The Massachusetts Register

Issue: 1227, Date: 2/1/2013

Published by: The Secretary of the Commonwealth, William Francis Galvin, Secretary $10.00

Page

THE GENERAL COURT Acts and Resolves 1

OFFICE OF THE SECRETARY OF THE COMMONWEALTH State Register of Historic Places 31

CENTER FOR HEALTH INFORMATION AND ANALYSIS Administrative Bulletin 13-01: 114.2 CMR 4.00: Resident Care Facilities, 114.2 CMR 6.00: Standard Payments to Nursing Facilities 33

EXECUTIVE OFFICE OF HEALTH AND HUMAN SERVICES Administrative Bulletin 13-01: 114.3 CMR 14.00: Dental Services 35 Administrative Bulletin 13-02: 114.3 CMR 6.00: Rates of Payment for Mental Health Services Provided in Community Health Centers and Mental Health Centers 39 Administrative Bulletin 13-03: 114.3 CMR 20.00: Coding Updates for Clinical Laboratory Services 41 Administrative Bulletin 13-04: CPT/HCPCS 2013 Coding Updates for 114.3 CMR 16.00: Surgery and Anesthesia Services, 114.3 CMR 17.00: Medicine, and 114.3 CMR 18.00: Radiology 45

ADMINISTRATIVE PROCEDURES Notices of Public Review of Prospective Regulations 59 Cumulative Table 113 Notice of Expiration of Emergency Regulation - Emergency Regulations - Permanent Regulations 117 Future Effective Date Regulations -

MASSACHUSETTS REGISTER (THE) (ISSN-08963681) is published biweekly for $300.00 per year by the Secretary of the Commonwealth, State House, Boston, MA 02133. Second Class postage is paid at Boston, MA. POSTMASTER: Send address change to: Massachusetts Register, State Bookstore, Room 116, State House, Boston, MA 02133.

Notice of Expiration of Emergency Regulation There are no Notices of Expiration on this Massachusetts Register.

Emergency Regulations

There are no Emergency Regulations in this Massachusetts Register

Permanent Regulations

101 CMR Executive Office of Health and Human Services 310.00 Adult Day Health Services 117 Establishes rate increases for adult day health services. Adds language to authorize the issuance of regulatory provisions via administrative bulletins, to clarify the filing and reporting requirements, and to update penalty language. Computes add-on rates for each service, applicable to services provided between 10/1/12 and 6/30/13 to maintain the annual impact of the rate increases.

105 CMR Department of Public Health 700.000 Implementation of M.G.L. c. 94C 119 Governs implementation of the Controlled Substances Act. Ensures: that the requirements for the prescription monitoring program (PMP) are consistent with statutory requirements; that the requirements for the prescriptive practice of nurse midwives are consistent with statutory requirements; and expands the Medication Administration Program (MAP) to facilities administered by the Department of Children and Families. 701.000 Regulations Adopted Jointly by the Department of Public Health and the Board of Registration in Pharmacy for the Implementation of M.G.L. c. 94C 121 Establishes rules for dispensing of certain drug products. Updates the language to be consistent with language in 105 CMR 700.000. 721.000 Standards for Prescription Format and Security in Massachusetts 123 Establishes rules for prescription format and security. Removes the requirement that a prescription issued by a nurse midwife include the name of a supervising physician. There are also minor technical amendments.

220 CMR Department of Public Utilities 18.00 Net Metering 125 Governs how Distribution Companies are to provide service to net metering customers and facilities. The emergency regulations, effective November 1, 2012, implemented amendments to the net metering provisions of M.G.L. c. 164, §§ 138 and 139 required by St. 2012, c. 209, §§ 23 through 30. In the final regulations, the DPU amended the emergency regulations by adding 220 CMR 18.07(8) which guarantees a small subset of Class I Net Metering Facilities the ability to net meter.

247 CMR Board of Registration in Pharmacy 2.00 Definitions - Compliance 127 6.00 Registration, Management and Operation of a Pharmacy or Pharmacy Department 129 Clarifies requirement that pharmacy obtain Board of Registration in Pharmacy approval prior to operation of central intravenous admixture services (revisions to 247 CMR 6.01(5)(c)). Establishes pharmacy and pharmacist duty to report certain factors of pharmacy operations to the Board of Registration in Pharmacy (new 247 CMR 6.15). 10.00 Disciplinary Proceedings 131 Inserts: definition of "conviction" (247 CMR 10.02); additional grounds for discipline of an individual or entity licensed by the Board of Registration in Pharmacy (247 CMR 10.03(1)); sections regarding summary cease and desist (247 CMR 10:06(8)) and quarantine (247 CMR 10.06(9)) notices that may be imposed by the Board of Registration in Pharmacy or Board President prior to hearing; and sections regarding summary cease and desist and quarantine notice process.

264 CMR Board of Registration of Real Estate Appraisers 1.00 Disciplinary Proceedings 133 Adopts the 2012-2013 edition of the Uniform Standards of Professional Appraisal Practice ("USPAP") that the Board must enforce in accordance with the Appraisal Foundation, the Board''s federal oversight authority. 5.00 Licensure/Certification Requirements 135 Addresses the education and work experience requirements necessary for licensure. Eliminates the use of certain old education/work experience, increases education requirements, and requires background checks of applicants per federal requirements.

8.00 Reciprocity for State-Licensed/State Certified Real Estate Appraisers 137 Addresses the Board’s ability to grant reciprocal licenses and licenses by endorsement. The Board meets new federal guidelines designed to reduce barriers on appraisers moving between different states.

606 CMR Department of Early Education and Care 10.00 Subsidized Child Care - Correction 139

956 CMR Commonwealth Health Insurance Connector Authority 7.00 Small Group Wellness Incentive Program 141 Implements provisions of M.G.L. c. 176Q, §7A. Applies to the Small Group Wellness Incentive Program offered to certain employers by the Commonwealth Health Insurance Connector Authority.

1 H 3450 Authorizing the Town of Great Barrington to Continue the 1/13/2012 Employment of Fire Chief, Harry Jennings and Deputy Fire Chief, Edward G. McCormick.

2 H 3447 Authorizing the City of Quincy to Abate Certain Fiscal Year 2010 1/13/2012 Real Property Taxes.

3 H 3548 Authorizing a Ballot Question in the Town of Arlington Relative to 1/13/2012 the Granting of Additional Licenses for the Sale of All Alcoholic Beverages not to be Drunk on the Premises.

4 S 1901 Authorizing Holyoke Community College to Borrow Funds for the 1/13/2012 Acquisition and Renovation of Certain Real Property in the City of Holyoke.

5 S 2095 Relative to the Election of the Freetown Lakeville Regional 1/17/2012 School District Committee Meeting.

6 H 3497 Authorizing the Town of Bolton to Grant a License for the Sale of 1/18/2012 All Alcoholic Beverages to be Drunk on the Premises.

7 H 3733 Establishing a Sick Leave Bank for Debra Callejas, an Employee 1/18/2012 of the Department of Industrial Accidents.

8 H 3533 Relative to the Granting of a Club License for the Sale of All 1/19/2012 Alcoholic Beverages to be Drunk on the Premises in the Town of Lincoln.

9 S 1878 Authorizing the Town of Peru to Establish a Fire Station 1/20/2012 Construction Fund.

10 S 1887 Authorizing the Town of Foxborough to Establish an Age Limit 1/20/2012 for Original Appointment to the Position of Police Officer.

11 H 3649 Further Regulating the Selectman - Town Manager Form of 1/20/2012 Government in the Town of Foxborough.

12 H 3712 Further Defining a Scenic Byway in the Towns of Arlington, 1/20/2012 Lexington, Lincoln and Concord.

13 H 3865 Establishing a Voting Precinct in the City of Newburyport. 1/27/2012

14 S 1948 Requiring Authorization by a Town Meeting Vote of Certain 1/27/2012 Contracts Made by the Town of Middleborough Regarding the Sale by the Town of Water or Wastewater Treatment Services.

15 H 3509 Authorizing the Town of Becket to Continue the Employment of 1/30/2012 the Chief of Police, William Elovirta. The foregoing was laid before the Governor on the nineteenth day of January, 2012 and after ten days has the force of law as prescribed by the Constitution as it was not returned by him to the branch in which it originated with his objections thereto within that time.

16 H 3486 Exempting the Position of Fire Chief in the City of Haverhill from 2/2/2012 the Civil Service Law.

17 H 3656 Relative to the City Clerk of the City of Revere. 2/2/2012

18 H 3647 Authorizing a Ballot Question in the Town of Arlington Relative to 2/2/2012 the Granting of Licenses for the Sale of Wines and Malt Beverages to be Drunk on the Premises in Certain Theaters.

19 H 3847 Relative to a Voting Precinct in the City of Peabody. 2/2/2012

20 S 2019 Authorizing the Town of Milton to Grant a License for the Sale of 2/2/2012 Wines and Malt Beverages to be Drunk on the Premises of a Certain Restaurant.

21 S 2025 Authorizing the City of Somerville to Incur Debt to Maintain 2/2/2012 Property Leased, Licensed, or Otherwise Under the Control of the City Pursuant to an Assessment Between the City and the Commonwealth.

22 H 3782 Relative to Voting Precincts in the City of Revere. 2/2/2012

23 H 3699 Authorizing the Town of Danvers to Grant an Additional License 2/2/2012 for the Sale of Wines and Malt Beverages to be Drunk on the Premises.

24 H 3815 Relative to Enhancing the Practice of Nurse-Midwives. 2/2/2012

25 H 3901 Authorizing the Town of Wellesley to Place a Certain Question 2/3/2012 Relative to the Sale of Alcoholic Beverages on the Town's Election Ballot.

26 H 3823 Establishing a Sick Leave Bank for Pamela Shuttle, an 2/9/2012 Employee of the Department of Public Health.

27 H 3459 Relative to the Granting of Club and Special Licenses for the 2/10/2012 Sale of Alcoholic Beverages in the Town of Weston.

28 H 3827 Authorizing the Town of Lincoln to Place a Certain Question on 2/10/2012 the Ballot Relative to the Sale of All Alcoholic Beverages to be Drunk on the Premises.

29 H 3460 Relative to Town Meeting Warrants in the Town of Templeton. 2/10/2012

30 H 3512 Authorizing the Town of Lincoln to Place a Certain Question on 2/14/2012 the Ballot Relative to the Granting of a License for the Sale of Wines and Malt Beverages not to be Drunk on the Premises.

31 H 3899 Designating an Additional Voting Precinct in the City of Quincy. 2/14/2012

32 H 3907 Establishing a Voting Precinct in the Town of Hingham. 2/14/2012

33 S 2117 Establishing a Sick Leave Bank for Frank Silveira, an Employee 2/15/2012 of the Department of Revenue.

34 S 1962 Establishing a Sick Leave Bank for Michael Monterio, an 2/15/2012 Employee of the Department of Correction.

35 S 1986 Authorizing the Sale of Land by the Wakefield Housing Authority. 2/15/2012

36 S 2112 Making Appropriations for the Fiscal Year 2012 to Provide for 2/17/2012 Supplementing Certain Existing Appropriations and for Certain Other Activities and Projects. Items 8910-0105, 8910-8200, 8910-8300 of Section 2 and Sections 36 and 37 were returned by the Governor to the Senate, the branch in which they originated, with his objections thereto. Said Items 8910- 0105, 8910-8200, 8910-8300 of Section 2 and Sections 36 and 37 were passed by the Senate on March 1, 2012, and in concurrence by the House of Representatives on March 7, 2012. The objection of the Governor notwithstanding, and in the manner prescribed by the Constitution, said Items and Sections therefore have the force of law. 37 H 3431 Authorizing the Town of Norton to Grant Easements and 2/17/2012 Restrictions Over Certain Town-owned Land.

38 S 1987 Providing Access to Forensic and Scientific Analysis. 2/17/2012

39 S 2067 Relative to a Uniform Anatomical Gift Act. 2/22/2012

40 H 3828 Relative to the Retirement of Penelope Harvey. 2/23/2012

41 H 3434 Authorizing the Appointment of Special Police Officers in the 2/24/2012 Town of Watertown.

42 H 3725 Authorizing the Town of Natick to Grant Certain Licenses for the 3/2/2012 Sale of Wines and Malt Beverages to be Drunk on the Premises.

43 S 2105 Relative to Improving Accountability and Oversight of Education 3/2/2012 Collaboratives.

44 S 2129 Establishing a Sick Leave Bank for Sharyn Lecesse, an 3/2/2012 Employee of the Registry of Motor Vehicles.

45 H 3956 Relative to Voting Precincts in the City of Chicopee. 3/5/2012

46 H 3958 Relative to a Voting Precinct in the Town of Dracut. 3/5/2012

47 H 3463 Relative to the Regulation of Salaries of Employees of the Town 3/9/2012 of Weston Serving in the Armed Forces of the United States.

48 H 3490 Relative to Outstanding Excise Tax and the Towing of Motor 3/9/2012 Vehicles and Trailers in the City of Springfield.

49 S 2048 Validating Certain Elections in the Town of Dudley. 3/9/2012

50 S 2062 Relative to Certain Affordable Housing in the City of Taunton. 3/9/2012

51 H 3720 Relative to Students with Disabilities in Post-secondary 3/9/2012 Education, Employment and Independent Living.

52 H 3920 Relative to the Division of Transportation in the Town of 3/14/2012 Brookline.

53 H 3738 Authorizing the City of Fitchburg to Grant an Additional License 3/14/2012 for the Sale of Wines and Malt Beverages not to be Drunk on the Premises.

54 S 2088 Establishing a Sick Leave Bank for Michael Foti, an Employee of 3/14/2012 the Department of Correction.

55 H 3894 Establishing a Sick Leave Bank for Catherine Blais, an Employee 3/15/2012 of the Trial Court.

56 H 3763 Providing for a Charter for the Town of Westford. 3/19/2012

57 S 2104 Relative to the Town Clerk in the Town of Tewksbury. 3/22/2012

58 S 1967 Relative to Community Housing and Services. 3/22/2012

59 H 3740 Designating a Certain Bridge in the City of Attleboro as the Lynn 3/22/2012 Goodchild and Shawn Nassaney September 11th Memorial Bridge.

60 H 3754 Providing Retirement Options for Nonprofit Organizations. 3/22/2012

61 S 2148 Relative to Tiered and Selective Network Health Plans. 3/23/2012

62 H 3716 Relative to the Number of Voting Precincts in the Town 3/23/2012 Chelmsford.

63 S 2186 Relative to the Charter of the Town of Norwell. 4/2/2012

64 H 3853 Relative to the Procurement and Award of Contracts for Certain 4/4/2012 Affordable Housing in the City of Boston.

65 H 3638 Designating a Certain Bridge in the Town of Dalton as the 2nd 4/4/2012 Lt. Michael J. Casey, Sr. Memorial Bridge.

66 H 3666 Relative to Compensated Absences in Cities and Towns. 4/4/2012

67 H 3953 Relative to a Certain Parcel of Land in the Town of Freetown. 4/6/2012

68 S 2174 Relative to the Dighton Water District in the Town of Dighton. 4/6/2012

69 H 2328 Authorizing the Town of Dartmouth to Establish a Trust Fund for 4/6/2012 Police Officer Municipal Benefits.

70 H 3333 Relative to the Duration of Contracts for the Position of Chief of 4/6/2012 Police in the Town of Natick.

71 H 3715 Authorizing the Town of Harvard to Issue One-day Liquor 4/6/2012 Licenses.

72 H 3843 Validating the Actions Taken at a Certain Town Meeting in the 4/11/2012 Town of Abington.

73 H 3728 Relative to the Recall of Elected Officers in the Town of 4/18/2012 Chelmsford.

74 H 3976 Establishing a Sick Leave Bank for Janet Ruggieri, an Employee 4/18/2012 of the Department of Revenue.

75 H 3910 Establishing a Sick Leave Bank for Pearlene Odom, an 4/18/2012 Employee of the Massachusetts Department of Transportation.

76 H 4015 Relative to the Appointment of Department Heads in the Town of 4/18/2012 Brookline.

77 S 2132 Relative to Medical Emergency Response Plans for Schools. 4/18/2012

78 H 3757 Designating a Certain Bridge on Interstate Highway Route 195 in 4/18/2012 the Town of Wareham as the First Sergeant Charles W. Parker Memorial Bridge.

79 H 3800 Amending the Charter of the Town of Westborough. 4/18/2012

80 S 1915 Authorizing the Town of Kingston to Install, Finance and Operate 4/18/2012 Wind Energy Facilities.

81 S 2051 Authorizing the Town of Wilbraham to Lease Certain Land. 4/18/2012

82 S 2107 Designating World Voice Week. 4/18/2012

83 H 3834 Authorizing the Town of Scituate to Continue the Employment of 4/26/2012 the Chief of Police, Brian E. Stewart.

84 S 2158 Increasing Screening for HIV. 4/27/2012

85 H 3869 Increasing the Membership of the Town Forest Committee of the 5/1/2012 Town of Natick.

86 H 3575 Designating a Certain Building in the City of Holyoke as the 5/1/2012 Raymond P. Murray, Jr. Congregate House.

87 H 99 Authorizing the Licensing Board for the City of Boston to Grant 5/3/2012 Restricted Airport Licenses for the Sale of All Alcoholic Beverages and for the Sale of Wines and Malt Beverages at Logan International Airport.

88 H 3950 Relative to the Supplemental Reserve Fund to Ensure Fiscal 5/3/2012 Stability in the Town of Swansea.

89 H 4032 Validating the Actions Taken at the Annual Town Election in the 5/10/2012 Town of Wareham.

90 H 3935 Establishing a Sick Leave Bank for Stephen Gladding, an 5/10/2012 Employee of the Massachusetts Department of Transportation.

91 H 3892 Authorizing the City of Woburn to Place a Certain Question on 5/10/2012 the State Election Ballot Relative to the Granting of Licenses for the Sale of Wines and Malt Beverages to be Drunk on the Premises of Certain Restaurants.

92 H 3668 Authorizing the Town of Natick to Grant an Additional License for 5/10/2012 the Sale of Wines and Malt Beverages not to be Drunk on the Premises.

93 H 3487 Authorizing the Board of Selectmen of the Town of Sherborne to 5/10/2012 Enter into an Employment Contract for the Position of Police Chief.

94 H 3758 Relative to the Mattapoisett River Valley Water District. 5/10/2012

95 H 3833 Relative to Shellfish Aquaculture License Fees in the Town of 5/10/2012 Mattapoisett.

96 H 4079 Making Appropriations for the Fiscal Year 2012 to Provide for 5/11/2012 Supplementing Certain Existing Appropriations and for Certain Other Activities and Projects. Sections 3 and 4 were returned by the Governor to the House of Representatives, the branch in which they originated, with his objection thereto. Said Sections 3 and 4 were passed by the House of Representatives on May 30, 2012, and in concurrence by the Senate on June 6, 2012. The objection of the Governor notwithstanding, and in the manner prescribed by the Constitution, said Sections therefore have the force of law.

97 H 3504 Amending the Charter of the Town of Harwich. 5/16/2012

98 H 3502 Increasing the Expenditure Limit on the Parks and Recreation 5/16/2012 Revolving Fund in the Town of Hanover.

99 H 3967 Establishing a Sick Leave Bank for Cheryl A. Cole, an Employee 5/16/2012 of the Office of Medicaid.

100 H 3955 Designating a Certain Pedestrian Bridge in the City of Revere as 5/16/2012 the Christina Markey and John Markey Memorial Pedestrian Bridge and the New Maintenance Facility for the Department of Conservation and Recreation Located in the City of Revere as the Captain Arthur "Icy" Reinstein Memorial Maintenance Facility.

101 H 4028 Establishing a Sick Leave Bank for Karen Langley, an Employee 5/17/2012 of the Executive Office of Health and Human Services.

102 H 3665 Validating the Actions Taken at the Annual Town Meeting in the 5/18/2012 Town of North Andover.

103 H 3503 Amending the Charter of the Town of Harwich. 5/23/2012

104 S 2246 Authorizing the Town of Essex to Sell or Lease Certain Real 5/23/2012 Estate at Conomo Point.

105 H 3996 Relative to the Town of Swansea Volunteer Fire Department. 5/23/2012

106 H 3625 Relative to Oversight of Private Occupational Schools. 5/24/2012

107 S 1724 Designating a Certain Bridge in the Town of Barre as the Purple 5/24/2012 Heart Bridge.

108 S 2254 Relative to Veterans' Access, Livelihood, Opportunity and 5/31/2012 Resources.

109 S 1958 Authorizing the Commissioner of Capital Asset Management and 6/1/2012 Maintenance to Grant Easements Within Monroe State Forest.

110 H 3849 Authorizing the City of Holyoke to Convey a Certain Parcel of 6/1/2012 Land to the Holyoke Community College Foundation.

111 H 3593 Authorizing the Appointment of Sean C. Lewis, Sr. as a 6/13/2012 Firefighter in the Town of North Andover Notwithstanding the Maximum Age Requirement.

112 S 1049 Authorizing the Town of Plymouth to Make Improvements to 6/13/2012 Unaccepted Roads.

113 S 2030 Authorizing the Town of Plymouth to Establish an Other Post- 6/13/2012 Employment Benefits Fund.

114 H 3844 Establishing a Sick Leave Bank for Paula Connelly, an Employee 6/13/2012 of the Trial Court.

115 S 2131 Establishing a Sick Leave Bank for Carl Senna, an Employee of 6/13/2012 the Department of Correction.

116 S 2161 Establishing a Sick Leave Bank for Judith Christianson, an 6/13/2012 Employee of the Department of Transitional Assistance.

117 S 2114 Amending the Charter of the Town of Bourne. 6/13/2012

118 H 4144 Making Appropriations for the Fiscal Year 2012 to Provide for 6/19/2012 Supplementing Certain Existing Appropriations and for Certain Other Activities and Projects.

119 H 4125 Providing for Certain Reforms Relative to the Massachusetts 6/21/2012 Department of Transportation.

120 S 2230 Relative to the Essex Regional Retirement System. 6/21/2012

121 H 4029 Establishing a Sick Leave Bank for Dacia Thompson, an 6/21/2012 Employee of the Department of Children and Families.

122 S 1949 Authorizing the Board of Selectmen in the Town of 6/21/2012 Middleborough to Impose Fees for the Employment of Senior Consultants.

123 H 3969 Establishing a Sick Leave Bank for Janet Ochner, an Employee 6/21/2012 of the Department of Developmental Services.

124 H 4065 Establishing a Sick Leave Bank for Mark Lewis, an Employee of 6/21/2012 the Department of Developmental Services.

125 H 537 Providing for the Protection of Volunteer Emergency Medical 6/21/2012 Technicians from Dismissal.

126 H 3825 Requiring Certain Information Relative to Down Syndrome be 6/22/2012 Provided to Certain Parents and Families.

127 H 4195 Making Certain Appropriations for Fiscal Year 2013 Before Final 6/25/2012 Action on the General Appropriation Bill.

128 H 3719 Authorizing the Town of Topsfield to Convey Certain 6/29/2012 Conservation Land.

129 S 2273 Relative to the Sale of Alcoholic Beverages in the Town of 6/29/2012 Wenham.

130 S 2234 Authorizing the Conveyance of Certain Properties by the Melrose 6/29/2012 Housing Authority in the City of Melrose.

131 S 2315 Providing for the Implementation of Education Evaluation 6/29/2012 Systems in School Districts.

132 H 4174 Relative to Financing and Reforming Public Transportation in the 6/29/2012 Commonwealth.

133 S 2329 Financing Improvements to the Commonwealth's Transportation 6/29/2012 System.

134 H 4194 Validating the Actions Taken at a Certain Town Election Held in 6/29/2012 the Town of Rowe.

135 H 4094 Establishing a Sick Leave Bank for Patricia Chasse, an 7/3/2012 Employee of the Department of Children and Families.

136 H 3972 Establishing a Sick Leave Bank for Mary M. Stanton, an 7/3/2012 Employee of the Department of Developmental Services.

137 S 2272 Establishing a Sick Leave Bank for Brian J. Waldron, an 7/3/2012 Employee of the Trial Court.

138 H 4089 Relative to Clear and Conspicuous Price Disclosure. 7/3/2012

139 H 4200 Making Appropriations for the Fiscal Year 2013 for the 7/8/2012 Maintenance of the Departments, Boards, Commissions, Institutions and Certain Activities of the Commonwealth, for Interest, Sinking Fund and Serial Bond Requirements and for Certain Permanent Improvements.

140 S 2128 Further Regulating the Probate Code and Establishing a Trust 7/8/2012 Code.

141 S 2218 Designating Certain Bridges in the Town of Bourne as the Staff 7/8/2012 Sergeant Matthew A. Pucino Bridge.

142 H 3947 Providing for Dementia-Specific Training for Certain Employees 7/8/2012 of Long-Term Care Facilities.

143 H 4219 Establishing the Social Innovation Financing Trust Fund and 7/8/2012 Authorizing the Lease of the Henderson Boat House.

144 H 3911 Authorizing Certain Licenses of the Division of Banks to 7/12/2012 Participate in a Multi-State Licensing System.

145 H 4005 Establishing a Sick Leave Bank for Michael W. Regan, an 7/12/2012 Employee of the Massachusetts Department of Transportation.

146 S 2232 Designating the Birthplace of Michael Bartlett and Dr. Elliot P. 7/12/2012 Joslin in the Town of Oxford.

147 H 4166 Establishing a Sick Leave Bank for Chereel Stafilopatis, an 7/18/2012 Employee of the Executive Office of Health and Human Services.

148 H 4159 Establishing a Sick Leave Bank for Clifton Watson, an Employee 7/18/2012 of the Registry of Motor Vehicles.

149 S 2093 Authorizing the Town of Erving to Grant an Additional License for 7/18/2012 the Sale of All Alcoholic Beverages not to be Drunk on the Premises.

150 H 3524 Authorizing the Town of Tyringham to Continue the Employment 7/18/2012 of the Chief of Police, Peter Curtin.

151 H 3710 Relative to Hamilton Development Corporation. 7/18/2012

152 S 2162 Further Regulating Business Practices Between Motor Vehicle 7/18/2012 Dealers, Manufacturers and Distributors.

153 S 2075 Relative to Water Safety for Children. 7/18/2012

154 H 3332 Authorizing the Town of Natick to Lease or Sell the Former East 7/24/2012 School.

155 H 3525 Authorizing the Town of Tyringham to Continue the Employment 7/24/2012 of Rainsford Morehouse, a Member of the Police Department.

156 S 97 Authorizing the Town of Hawley to Grant a License for the Sale 7/24/2012 or Service of Wine to be Drunk on the Premises of a Farmer- Winery.

157 S 2319 Establishing a Sick Leave Bank for Heidi A. Lennon, an 7/24/2012 Employee of the Department of Children and Families.

158 S 1787 Designating a Certain Bridge in the City of Boston as the 7/24/2012 Honorable Francis X. Coppinger Bridge.

159 S 1788 Designating a Certain Bridge in the City of Boston as the 7/24/2012 Honorable Charles Doyle Bridge.

160 H 4156 Designating a Certain Overpass in the Town of Yarmouth as the 7/25/2012 Marine Corporal Nicholas G. Xiarhos Veterans Memorial Overpass.

161 H 4237 Relative to the Electronic Benefit Transfer Program. 7/27/2012

162 H 843 Establishing Fragile X Awareness Day. 7/27/2012

163 H 3909 Authorizing the Division of Capital Asset Management and 7/27/2012 Maintenance to Grant an Easement in Certain Land in the Town of Hopkinton.

164 H 4235 Relative to the Terms of Certain Bonds Issued by the 7/27/2012 Commonwealth.

165 S 2342 To Improve the Administration of State Government and Finance. 7/27/2012

166 H 3870 Authorizing the Town of Natick to Lease Certain Town-Owned 7/27/2012 Property.

167 H 3871 Authorizing the Town of Natick to Lease Certain Town-Owned 7/27/2012 Property.

168 H 4158 Establishing a Sick Leave Bank for Lawrence Marino, an 7/27/2012 Employee of the Registry of Motor Vehicles.

169 H 4062 Authorizing the Town of Sudbury to Establish a Means Tested 7/27/2012 Senior Citizen Property Tax Exemption.

170 S 1718 Relative to Identification Cards. 7/30/2012

171 S 2320 Authorizing the Town of Groveland to Provide for the 7/30/2012 Construction and Maintenance of a Solar Generating Facility on Land Held for Water Supply Purposes.

172 H 3836 Authorizing the Nantucket Islands Land Bank to Sell, Convey or 7/30/2012 Otherwise Dispose of Certain Land Situated in the Town of Nantucket.

173 H 3650 Authorizing the Town of Hull to Extend the Lease of a Certain 7/30/2012 Building in the Town.

174 H 3881 Authorizing the Town of Chelmsford to Lease Sunny Meadow 7/30/2012 Farm.

175 H 4170 Authorizing the Town of Reading to Grant a Utility Easement 7/30/2012 Over Certain Parcels of Land.

176 H 920 Designating a State Road in the City of Waltham as Library Way. 7/30/2012

177 H 3856 Providing for the Lease and Refurbishment of the Bathing Beach 7/30/2012 Bathhouse in the Town of Hingham.

178 H 4238 Relative to the Registration of Motor Vehicles and Trailers. 7/31/2012 This bill was returned by the Governor to the House of Representatives, the branch in which it originated, with his objections thereto, was passed by the House of Representatives on July 30, 2012, and in concurrency by the Senate on July 30, 2012, the objectons of the Governor notwithstanding, in the manner prescribed by the Constitution, and therefore has the force of law. 179 H 4052 Relative to the Management of Town Buildings, Properties and 7/31/2012 Facilities in the Town of Foxborough.

180 S 2215 Authorizing a Lease of a Certain Parcel of Land Under the 7/31/2012 Control of the Department of Fish and Game to the Bourne Water District for Water Distribution Purposes.

181 H 3794 Relative to the Transfer of Land in the Town of Sharon. 8/1/2012

182 S 2367 Authorizing the Commissioner of the Division of Capital Asset 8/1/2012 Management and Maintenance to Convey Certain Land in New Bedford to the City of New Bedford.

183 H 3919 Authorizing the Town of Truro to Amend a Certain Conservation 8/1/2012 Restriction.

184 H 4327 Authorizing the Exchange of Land in the Town of Rockland. 8/1/2012

185 H 4336 Authorizing the Town of Maynard to Transfer a Certain Parcel of 8/1/2012 Conservation Land.

186 H 3312 Relative to the Exchange of Certain Land in the Town of Truro. 8/1/2012

187 H 3765 Relative to the Regulation of Cyber Cafes. 8/1/2012

188 H 3791 Relative to the Transfer of Certain Insurance Policies Among 8/1/2012 Certain Insurance Company Affiliates.

189 H 3986 Relative to Early Education and Care by Family Child Care 8/1/2012 Providers.

190 S 2063 Providing for Annual Caterer's Licenses for the Service of 8/1/2012 Alcoholic Beverages at Private Functions.

191 H 2366 Relative to Public Access of Private Restrooms. 8/1/2012

192 H 3818 Relative to Sentencing and Improving Law Enforcement Tools. 8/2/2012

193 S 2192 Further Regulating Animal Control. 8/2/2012

194 H 4323 Preventing Unlawful and Unnecessary Foreclosures. 8/3/2012

195 H 4335 Authorizing the Town of Maynard to Temporarily Transfer a 8/3/2012 Certain Parcel of Recreation Land for a Large Scale Photovoltaic System.

196 S 2154 Authorizing the Massachusetts Water Resources Authority to 8/3/2012 Provide Additional Sewer Services Through the City Known as the Town of Weymouth to the Town of Hingham.

197 H 4365 Authorizing the Exchange of Certain Parcels of Land in the Town 8/3/2012 of Marshfield.

198 S 2233 Authorizing the Division of Capital Asset Management and 8/3/2012 Maintenance to Grant to the City of Lowell Easements Over Certain Parcels of Land.

199 H 4171 Authorizing the Town of Wellfleet to Grant an Easement on 8/3/2012 Certain Land in the Town.

200 H 4272 Authorizing the Commissioner of Capital Asset Management and 8/3/2012 Maintenance to Convey Certain Land to the Foxborough Housing Authority.

201 H 4341 Authorizing and Directing the Commissioner of Capital Asset 8/3/2012 Management and Maintenance to Convey Certain Land in the Town of South Hadley.

202 S 2369 Relative to the Conveyance of Easements in the Town of Sutton. 8/3/2012

203 H 4033 Authorizing the Conveyance, Lease and Change of Use of 8/3/2012 Certain Park Lands in the City of Worcester.

204 H 4192 Establishing a Sick Leave Bank for Susan Tremblay, an 8/3/2012 Employee of the Department of Correction.

205 H 4278 Authorizing the Change of Use and the Lease of Certain Land in 8/3/2012 the Town of Lee for a Solar Powered Generation Facility.

206 S 2092 Relative to Superintendency Union Benefits. 8/3/2012

207 H 4187 Relative to Authorizing the Town of Needham to Authorize the 8/3/2012 Sale of All Alcoholic Beverages not to be Drunk on the Premises.

208 S 2216 Requiring the Registration of Motor Vehicles Glass Repair Shops. 8/3/2012

209 S 2395 Relative to Competitively Priced Electricity in the Commonwealth. 8/3/2012

210 H 4009 Authorizing the Town of Orange to Convey a Certain Parcel of 8/6/2012 Land.

211 S 2250 Authorizing the Massachusetts Department of Transportation to 8/6/2012 Acquire Certain Parcels of Land in the City of Worcester.

212 H 4342 Authorizing the Division of Capital Asset Management and 8/6/2012 Maintenance to Convey Certain Parcels of Land in the Town of Shrewsbury.

213 S 2385 Authorizing the Massachusetts Department of Transportation to 8/6/2012 Acquire a Parcel of Land in the Town of Hinsdale.

214 H 4277 Authorizing the Change of Use and the Lease of Certain Land in 8/6/2012 the Town of Lenox for a Solar Powered Generation Facility.

215 H 4103 Relative to Certain Conservation Restrictions in the Town of 8/6/2012 Canton.

216 S 2143 Relative to the Emergency Service Response of Public Utility 8/6/2012 Companies.

217 H 4340 Authorizing the Commissioner of Capital Asset Management and 8/6/2012 Maintenance to Convey a Certain Parcel of Land in the Town of Halifax.

218 H 4075 Authorizing the Town of Northborough to Convey Certain 8/6/2012 Parklands to Abutters.

219 H 4273 Authorizing the Department of Fish and Game to Exchange 8/6/2012 Certain Property in the Town of Shirley for Other Property in the Same Town.

220 H 2073 Establishing a Reserve Fund for Credit Unions. 8/6/2012

221 H 4202 Authorizing the Massachusetts Water Resources Authority to 8/6/2012 Convey Certain Land to the City of Chelsea Without a Restriction on its Use.

222 H 4332 Relative to Student Access to Educational Services and 8/6/2012 Exclusion from School.

223 S 2383 Authorizing the Lease of the Daly Field Complex Located in the 8/6/2012 Brighton Section of the City of Boston.

224 S 2400 Improving the Quality of Health Care and Reducing Costs 8/6/2012 Through Increased Transparency, Efficiency and Innovation.

225 H 4304 Establishing a Temporary Workers Right to Know. 8/6/2012

226 H 4339 Authorizing the Division of Capital Asset Management and 8/6/2012 Maintenance to Grant an Easement Over a Parcel of Land in the Town of Needham in Exchange for a Parcel of Land to be Conveyed to the Commonwealth.

227 H 2040 Relative to Limited Purpose Trust Companies. 8/6/2012

228 H 4230 Authorizing the Town of Cohasset to Transfer Certain Interests in 8/6/2012 Land.

229 H 4172 Authorizing the Town of Fairhaven to Grant an Easement Over 8/6/2012 Certain Land.

230 S 2408 Relative to Simulcasting. 8/6/2012

231 H 3886 Authorizing the Town of Groton to Convey a Certain Parcel of 8/6/2012 Land to the Department of Fish and Game and Place Conservation Restrictions on Certain Parcels of Land.

232 S 2338 Authorizing the Division of Capital Asset Management and 8/6/2012 Maintenance to Lease Certain Property in the City of Lawrence to the Greater Lawrence Community Boating Program, Inc.

233 H 52 Providing Hearing Aids for Children. 8/6/2012

234 H 3928 Relative to the Treatment of Cleft Palate and Cleft Lip. 8/6/2012

235 H 3806 Relative to Co-operative Banks. 8/6/2012

236 H 1402 Relative to Collective Bargaining Agreements. 8/6/2012

237 H 4242 Relative to Renovation and Repair Contracts. 8/6/2012

238 H 4352 Relative to Infrastructure Investment, Enhanced Competitiveness 8/7/2012 and Economic Growth in the Commonwealth. This bill was returned on August 7, 2012, by the Governor to the House, the branch in which said bill was originated, with His objections in writing to the following items therein: Items Disapproved: SECTIONS: 7, 26, 27, 28, 31, 32, 33, 34, 35A, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 96, 87, 99, and proposed section 38DD of chapter 96 of the General Laws inserted by SECTION 35 of this bill. The remainder of the bill was approved by the Governor on August 7, 2012 at ten o'clock and forty-five minutes, A.M Emergency Letter: August 7, 2012 @ 4:12 P.M. 239 H 4334 Making Appropriations for the Fiscal Year 2012 to Provide for 8/7/123 Supplementing Certain Existing Appropriations and for Certain Other Activities and Projects.

240 S 2410 Regarding Families and Children Engaged in Services. 8/7/2012

241 H 4362 Protecting Motor Vehicle Owners and Small Businesses in 8/7/2012 Repairing Motor Vehicles.

242 H 4371 Financing Improvements to the Commonwealth's Transportation 8/9/2012 System.

243 H 3951 Designating a Certain Bridge in the City of Lowell as the Gentz 8/9/2012 Brothers Memorial Bridge.

244 S 2125 Relative to Prescription Drug Diversion, Abuse and Addiction. 8/18/2012

245 H 3820 Restricting the Ability of the Water Supply District of Acton to 8/22/2012 Acquire Ground Water Sources in the Town of Boxborough.

246 S 2178 Modifying the Pittsfield Economic Development Authority. 8/22/2012

247 H 4164 Authorizing the City of Newburyport to Acquire Interests in Land 8/22/2012 in the Town of Newbury.

248 S 1065 Establishing a Sewer Construction Fund for the Town of 8/22/2012 Barnstable.

249 S 2106 Increasing the Membership on the Board of Health in the City of 8/22/2012 Northampton.

250 H 4280 Establishing a Sick Leave Bank for Louise Moson, an Employee 8/22/2012 of the Massachusetts Department of Transportation.

251 H 4229 Establishing a Sick Leave Bank for Diane Johnson, an Employee 8/22/2012 of the Department of Revenue.

252 S 2266 Establishing a Sick Leave Bank for Julie Nantais, an Employee 8/22/2012 of the Department of Public Health.

253 H 3826 Relative to Premature Infant Hospital Discharge and Quality 8/22/2012 Improvement.

254 S 2111 Establishing the Afterschool and Out-of-School Time 8/22/2012 Coordinating Council.

255 H 3717 Relative to Adding the Town of Harvard to the Devens Economic 8/22/2012 Target Area.

256 S 2126 Authorizing Governmental Bodies to Enter Into Contracts for the 8/22/2012 Inspection, Maintenance, Repair or Modification of Water Storage Facilities.

257 S 2286 Designating a Portion of the Route 128 Extension in the City of Gloucester as the Purple Heart Highway.

258 H 4378 Establishing a Sick Leave Bank for Timothy J. O'Brien, an 8/29/2012 Employee of the Executive Office of Health and Human Services.

259 S 2337 Designating Certain Bridges Under the Control of the 8/29/2012 Massachusetts Department of Transportation in the Town of Raynham and the City of Taunton.

260 S 2339 Establishing a Sick Leave Bank for Laurie Bourassa, an 8/29/2012 Employee of the Department of Developmental Services.

261 H 3937 Authorizing the Town of Hopedale to Allow Direct Deposit of 8/29/2012 Receipts Into Certain Funds.

262 H 4306 Relative to the Regulation of Plant Nutrients. 8/29/2012

263 H 3421 Designating a Certain Section of State Highway Route 53 in the 9/4/2012 City Known as the Town of Weymouth as the Stephen T. O'Donnell Memorial Highway.

264 H 4039 Exempting the Town of Southbridge from Attorney General 9/12/2012 Approval of By-Laws.

265 H 4040 Relative to Non-councilors on Committees in the Town of 9/12/2012 Southbridge.

266 H 4041 Relative to the Removal of the Vice-chairperson of the Council of 9/12/2012 the Town of Southbridge.

267 H 4042 Relative to the Prohibition of Multiple Appointments to Quasi- 9/12/2012 judicial Boards in the Town of Southbridge.

268 H 4043 Relative to the Addition of Members to the Board of Health in the 9/12/2012 Town of Southbridge.

269 H 4044 Relative to the Appointment of the Liquor Licensing Board in the 9/12/2012 Town of Southbridge.

270 H 4045 Relative to the Rescission of Appointments to Quasi-judicial 9/12/2012 Bodies in the Town of Southbridge.

271 H 4046 Relative to the Removal of the Manager of the Town of 9/12/2012 Southbridge.

272 4047 Relative to the Prohibition on Commercial Manufacturing or Sale 9/12/2012 of Alcohol by the Members of the Liquor Licensing Board of the Town of Southbridge.

273 H 4048 Relative to the Recall of Elective Officers in the Town of 9/12/2012 Southbridge.

274 S 2417 Establishing a Sick Leave Bank for June Graham, an Employee 9/12/2012 of the Department of Public Health.

275 H 4135 Validating the Actions Taken at a Certain Election Held in the 9/12/2012 Town of Lincoln.

276 H 4019 Designating Male Breast Cancer Awareness Week. 9/12/2012

277 H 4102 Revising the Charter for the City of Northampton. 9/12/2012

278 S 2316 Further Regulating the Position of Chief of Police in the Town of 9/12/2012 Millbury.

279 H 3970 Designating a Certain Bridge on Route 6 in the City of New 9/12/2012 Bedford as the Roland J. Hebert Bridge.

280 S 2294 Authorizing the City of Northampton to Grant an Additional 9/12/2012 License for the Sale of All Alcoholic Beverages to be Drunk on the Premises.

281 H 4030 Relative to the Appointment and Status of the Fire Chief and the 9/14/2012 Board of Fire Commissioners in the City of Fall River.

282 H 4294 Authorizing the City of Boston to Grant a Club License for the 9/14/2012 Sale of All Alcoholic Beverages to be Drunk on the Premises to the Irish Social Club Inc. of Boston.

283 H 4188 Relative to the Town of Marion Open Space Acquisition 9/20/2012 Commission.

284 H 4213 Exempting Certain Positions in the City of Gardner from the Civil 9/20/2012 Service Laws.

285 H 4246 Authorizing the City of Medford to Grant Additional Licenses for 9/20/2012 the Sale of All Alcoholic Beverages to be Drunk on the Premises.

286 H 4214 Exempting Certain Positions in the City of Gardner from the Civil 9/20/2012 Service Laws.

287 H 4243 Relative to Third Grade Reading Proficiency. 9/26/2012

288 H 4312 Relative to the Administrative Organization of Financial Officers 9/26/2012 in the City of Malden.

289 H 4184 Establishing a Sick Leave Bank for Gloria Chisholm, an 9/26/2012 Employee of the Massachusetts Department of Transportation.

290 H 4026 Exempting the Position of Deputy Police Chief in the Town of 9/26/2012 Duxbury from the Civil Service Law.

291 H 4311 Relative to Administrative Reorganization of the City of Malden. 9/26/2012

292 H 4209 Establishing a Charter for the Town of Hubbardston. 10/1/2012

293 S 2431 Establishing a Sick Leave Bank for Emmy Diaz, an Employee of 10/4/2012 the Massachusetts Rehabilitation Commission.

294 H 4399 Providing the Terms of Certain Bonds to be Issued by the 10/4/2012 Commonwealth to Finance Improvements to the Commonwealth's Transportation System.

295 H 4315 Relative to Authorizing the Board of Selectmen of the Town of 10/4/2012 Saugus to Hire an Auditing Firm to Conduct Annual Audits.

296 S 2381 Relative to the Use of Off-Highway and Recreation Vehicles. 10/4/2012

297 S 1959 Providing for Recall Elections in the Town of Norfolk. 10/11/2012

298 H 4211 Amending the Charter of the Town of Westborough. 10/11/2012

299 H 4319 Authorizing the Cedar Meadow Lake Watershed District to 10/11/2012 Prolong Retirement Payments.

300 H 3835 Authorizing the Appointment of Amy McCarthy as a Police 10/11/2012 Officer in the Town of North Andover Notwithstanding the Minimum Age Requirements.

301 S 72 Increasing Consumer Access to Licensed Marriage and Family 10/11/2012 Therapists.

302 H 4006 Relative to the New Bedford Police Association. 10/19/2012

303 H 4429 Establishing a Sick Leave Bank for Noelle Champoux-Olson, an 10/19/2012 Employee of the Department of Youth Services.

304 H 4353 Validating the Procedures at the Annual Town Meeting and the 10/19/2012 Annual Town Election in the Town of Heath.

305 S 2418 Establishing a Sick Leave Bank for Ellen Grady, an Employee of 10/19/2012 the Department of Public Health.

306 H 4292 Authorizing the City Known as the Town of Braintree to Grant 10/19/2012 Additional Liquor Licenses.

307 S 376 Establishing a Horseneck Beach Reservation Trust Fund. 10/19/2012

308 S 2239 Authorizing the Town of Rockport to Grant a License for the Sale 10/25/2012 of Wines and Malt Beverages at a Food Store.

309 H 4104 Relative to Special Police Officers in the Police Department of 10/25/2012 the City of Fitchburg.

310 H 3914 Validating Certain Actions Taken by the Old Colony Regional 10/25/2012 Vocational Technical High School District Relative to Certain Borrowing.

311 H 4163 Authorizing the Town of Sharon to Grant Licenses to Certain 10/25/2012 Establishments for the Sale of All Alcoholic Beverages to be Drunk on the Premises.

312 S 2359 Establishing Standards for Long-Term Care Insurance. 10/25/2012

313 S 361 Designating a Certain Node of the Blackstone River and Canal 10/25/2012 Heritage State Park in the Town of Uxbridge as the Effingham Capron Memorial Park.

314 S 2169 Designating a Certain Portion of Route 197 in the Town of 10/25/2012 Dudley as the Anthony B. DiDonato, Sr. Memorial Highway.

315 H 1802 Designating a Certain Bridge in the Town of Billerica as the 10/25/2012 William G. Greene, Jr. Bridge.

316 H 3845 Establishing the Melpet Farm Stable Operations and 10/25/2012 Improvement Fund for the Town of Dennis.

317 H 4389 Providing for the Appointment of Treasurer-Collector in the Town 10/26/2012 of Avon.

318 H 566 Relative to the Town of Tisbury Water Supply System. 10/26/2012

319 S 2288 Relative to the Charter of the City of Westfield. 10/26/2012

320 H 4142 Authorizing the Continued Employment of Thomas J. Osley, the 11/1/2012 Chief of Police of the Town of Hatfield.

321 H 4276 Authorizing Certain Development Parcel Tax Revenues to be 11/9/2012 Deposited into a Special Fund for the Town of Plympton.

322 H 4446 Establishing a Sick Leave Bank for Kathryn Woessner, an 11/9/2012 Employee of the Department of Correction.

323 S 2060 Establishing the Water and Sewer Commission on the Town of 11/9/2012 Dudley.

324 H 4450 Establishing a Sick Leave Bank for Kevin Lewis, an Employee of 11/14/2012 the Department of Developmental Services.

325 H 4317 Authorizing the Falmouth Retirement Board to Acquire Real 11/14/2012 Property in the Town of Falmouth.

326 H 4203 Relative to Collection of Estimated Water Assessments and 11/14/2012 General Fund Reimbursement in the Town of Charlton.

327 H 4287 Designating a Certain Intersection in the Town of Watertown as 11/14/2012 Menton Corner.

328 H 4293 Authorizing the Town of Fairhaven to Grant an Additional 11/19/2012 License for the Sale of All Alcoholic Beverages not to be Drunk on the Premises.

329 H 4417 Establishing the Position of Deputy Chief of the Stoughton Police 11/19/2012 Department and Exempting the Position from the Civil Service Law.

330 H 3875 Exempting Jeanine Bonnayer from the Maximum Age 11/29/2012 Requirement for Applying for Civil Service Appointment as a Police Officer in the Town of Ware.

331 H 4470 Authorizing Adam A. Seguin to Take the Civil Service 11/29/2012 Examination for Appointment as a Police Officer in the Town of Ware Notwithstanding the Maximum Age Requirement.

332 H 4354 Validating the Actions Taken at Certain Town Meetings in the 11/29/2012 Town of Westminster.

333 S 2420 Authorizing the Town of Seekonk to Convert Seasonal Licenses 11/29/2012 to Annual Licenses for the Sale of All Alcoholic Beverages to be Drunk on the Premises.

334 S 2353 Authorizing the Town of Seekonk to Grant Additional Licenses 11/29/2012 for the Sale of All Alcoholic Beverages to be Drunk on the Premises.

335 S 2449 Establishing a Sick Leave Bank for Gary Vuolo, an Employee of 11/29/2012 the Department of Correction.

336 S 2295 Relative to the Charter of the Town of Plymouth. 11/29/2012

337 S 2305 Designating a Certain Bridge in the Town of Billerica as the 11/29/2012 Helen Knight Bridge.

338 H 1784 Designating a Certain Roundabout in the Town of Freetown as 11/29/2012 the Navy Petty Officer Second Class Tyler J. Trahan Memorial Roundabout.

339 H 3591 Relative to Funding of Collective Bargaining Agreements in the 11/29/2012 Town of North Andover.

340 H 4479 Establishing a Sick Leave Bank for Jennifer O'Connell, an 11/30/2012 Employee of the Department of Correction.

341 H 2389 Authorizing the Boston Fire Department to Train and Certify Fire 12/5/2012 Service Personnel in the City of Boston.

342 H 3848 Exempting the Position of Plumbing Inspector and Gas Fitting 12/5/2012 Inspector in the City of Newburyport from the Civil Service Law.

343 S 2452 Establishing a Sick Leave Bank for James A. O'Connor, an 12/7/2012 Employee of the Division of Professional Licensure.

344 H 4462 Validating the Acts and Procedures at a Special Town Election in 12/12/2012 the Town of Templeton.

345 S 2223 Further Regulating Certain Town Meeting Notices in the Town of 12/12/2012 Belmont.

346 S 2450 Establishing a Sick Leave Bank for Lori Roche, an Employee of 12/12/2012 the Department of Children and Families.

347 H 3708 Relative to Authorizing the Town of Aquinnah to Refund a 12/12/2012 Certain Tax Payment.

348 S 2304 Authorizing the Town of Arlington to Establish a Separate 12/12/2012 Account for Proceeds from Wireless Communications Antenna Leases.

349 H 4497 Establishing a Sick Leave Bank for Wendy Watts, an Employee 12/12/2012 of the Department of Youth Services.

350 S 1934 Authorizing the Town of Newbury to Use Certain Fund Balances 12/12/2012 for Capital Expenditures.

351 S 1941 Providing for the Establishment of a Fire Department in the Town 12/12/2012 of Newbury.

352 H 4456 Designating a Certain Area in the City of Revere as the Peter E. 12/12/2012 McCauley Memorial Plaza.

353 H 4457 Designating 2 Pavillions in the City of Revere as the Norman 12/12/2012 Gautreau Pavillions.

354 H 4430 Relative to Wastewater Treatment in the City of Fall River. 12/20/2012

355 H 4106 Establishing the Town of Acton Energy Efficiency Fund. 12/20/2012

356 H 4474 Establishing a Sick Leave Bank for Dazlee Alvarado, an 12/20/2012 Employee of the Massachusetts Department of Public Health.

357 H 4481 Establishing a Sick Leave Bank for Wayne Murray, an Employee 12/20/2012 of the Highway Division of the Massachusetts Department of Transportation.

358 H 4488 Establishing a Sick Leave Bank for Barbara A. Dichiaro, an 12/20/2012 Employee of the Registry of Motor Vehicles.

359 H 4512 Establishing a Sick Leave Bank for Judith Rocha, an Employee 12/20/2012 of the Department of Children and Families.

360 S 1879 Establishing a Special Reserve Fund in the Town of Millville. 12/20/2012

361 S 2454 Establishing a Sick Leave Bank for Susan Sciola, an Employee 12/20/2012 of the Department of Revenue.

362 H 3784 Further Regulating the Boston Art Commission. 12/20/2012

363 H 4232 Establishing the Position of Treasurer-Collector in the Town of 12/20/2012 Oakham.

364 S 2271 Authorizing the Town of Ashburnham to Dispose of Certain 12/21/2012 Equipment.

365 H 4310 Regulating the Grant of Sewer System Connections by the 12/21/2012 Board of Sewer Commissioners of the Town of Kingston.

366 H 3489 Authorizing Property Tax Exemptions for Rental Properties in the 12/21/2012 Town of Truro Restricted as Affordable Housing.

367 H 4484 Relative to Town Meeting Warrents in the Town of Templeton. 12/21/2012

368 H 3882 To Protect Motor Vehicle Owners and Small Businesses in 12/21/2012 Repairing Motor Vehicles.

369 H 3885 For the Humanitarian Medical Use of Marijuana. 12/21/2012

370 H 4134 Validating the Actions Taken at a Certain Annual Town Election 12/28/2012 in the Town of Blackstone.

371 S 2058 Regulating Surgical Technology. 12/28/2012

372 S 2289 Dissolving the Redevelopment Authority in the Town of 12/28/2012 Wilmington.

373 H 3572 Designating a Certain Bridge in the Town of Framingham as the 12/28/2012 Gregory B. Vilidnitsky Memorial Bridge.

374 H 1003 Relative to Psychology Training. 12/28/2012

375 H 4494 Authorizing the City of Easthampton to Grant an Additional 12/28/2012 License for the Sale of All Alcoholic Beverages to be Drunk on the Premises.

376 H 4495 Authorizing the City of Easthampton to Grant an Additional 12/28/2012 License for the Sale of All Alcoholic Beverages to be Drunk on the Premises.

377 H 4477 Relative to the Finance Committee of the Town of Provincetown. 12/28/2012

378 H 4189 Relative to Civil Service Positions in the City Known as the Town 12/28/2012 of Agawam.

379 H 4274 Establishing Commonwealth Virtual Schools. 1/2/2013

380 H 4313 Amending the Town Charter of Oxford. 1/2/2013

381 H 4468 Further Regulating the Sale of Alcoholic Beverages in the City of 1/2/2013 Somerville.

382 S 2471 Establishing a Sick Leave Bank for Donald Mahoney, an 1/2/2013 Employee of the Department of Correction.

383 H 4487 Relative to the Regional Wastewater District Enabling Act for the 1/2/2013 Towns of Mansfield, Foxborough and Norton.

384 S 2468 Authorizing the Town of Webster to Grant an Additional License 1/2/2013 for the Sale of All Alcoholic Beverages to be Drunk on the Premises.

385 H 3675 Authorizing the Town of Westwood to Grant Special Licenses for 1/2/2013 the Sale of All Alcoholic Beverages and Wines and Malt Beverages.

386 H 4233 Exempting the Position of Deputy Police Chief of the Town of 1/2/2013 Westwood from the Civil Service Laws.

387 S 2348 Relative to Municipal Acceptance of Roads Within a Subdivision 1/2/2013 in the Town of Medway.

388 H 4410 Establishing a Sick Leave Bank for Kathleen Rezendes, an 1/2/2013 Employee of the Department of Transitional Assistance.

389 H 4455 Relative to the Position of Appointed Highway Surveyor in the 1/2/2013 Town of Hanson.

390 H 4538 Establishing a Sick Leave Bank for Laura Flowers, an Employee 1/2/2013 of the Department of Children and Families.

391 H 4504 Establishing a Sick Leave Bank for Scott Giroux, an Employee of 1/2/2013 the Department of Mental Health.

392 S 2472 Establishing a Sick Leave Bank for Daniel Hermanski, Jr., an 1/2/2013 Employee of the Highway Division of the Massachusetts Department of Transportation.

393 H 3824 Relative to the Membership of the Conservation Commission of 1/2/2013 the Town of Richmond.

394 S 1187 Including Call and Volunteer Firefighters on the Massachusetts 1/2/2013 Fire Service Commission.

395 S 2292 Designating a Portion of Route 8 in the Town of Hinsdale as the 1/2/2013 Pvt. Henry T. Johns Memorial Highway.

396 H 180 Further Regulating the Commission on Falls Prevention. 1/2/2013

397 H 3997 Relative to Elected Water Commissioners in the Town of 1/2/2013 Harvard.

398 H 4295 Making Faculty Sabbatical Provisions at State Universities 1/2/2013 Consistent With Other Higher Education Institutions.

399 H 4445 Authorizing the Town of Milton to Borrow Money for the Payment 1/3/2013 of Certain Medical Expenses.

400 H 4440 Relative to the Charter of the City of Somerville. 1/3/2013

401 S 2455 Establishing a Sick Leave Bank for Yolanda Marrero, an 1/3/2013 Employee of the Trial Court.

402 S 2402 Relative to Housing Rights for Victims of Domestic Violence, 1/3/2013 Rape, Sexual Assault and Stalking.

403 S 2363 Relative to Oral Cancer Therapy. 1/3/2013 Emergency Letter: January 4, 2013 @ 12:09 P.M. 404 H 4316 Exempting Certain Positions in the Town of North Andover from 1/4/2013 the Civil Service Law.

405 H 4536 Further Regulating the Granting of Temporary Licenses for the 1/4/2013 Sale of Wines at Certain Auctions.

406 H 4496 Exempting the Position of Chief of Police of the Town of 1/4/2013 Springfield from the Provisions of the Civil Service Laws.

407 H 4438 Making Certain Amendments to the Charter of the Town of 1/4/2013 Abington.

408 H 3857 Relative to Health Insurance Benefits in the City of Lawrence. 1/4/2013

409 H 4390 Authorizing Certain Tax Revenue in the Town of Wareham to be 1/4/2013 Used for Capital Improvements.

410 H 4528 Increasing the Board of Selectmen Membership in the Town of 1/4/2013 Sudbury from Three to Five.

411 H 4314 Relative to the Charter of the Town of North Andover. 1/4/2013

412 H 3592 Amending the Charter of North Andover. 1/4/2013

413 H 3991 Relative to Tax Titles in the Town of East Bridgewater. 1/4/2013

414 H 3831 Relative to the Recall of Elective Offices in the Town of North 1/4/2013 Andover.

415 S 88 Relative to Anti-Freeze and Engine Coolant. 1/4/2013

416 S 2487 Establishing a Sick Leave Bank for Katrin Fox, an Employee of 1/8/2013 the Highway Division of the Massachusetts Department of Transportation.

417 H 901 Relative to Commuter Shuttles and Public Transportation 1/8/2013 Improvements.

418 S 2476 Exempting the Position of Police Chief in the City of Malden from 1/8/2013 the Civil Service Law.

419 S 2139 Relative to Residents of Continuing Care Retirement 1/8/2013 Communities.

420 S 2328 Increasing the Membership of Dental Hygienists on the Board of 1/8/2013 Registration in Dentistry.

421 S 2421 Making Technical Corrections to the Charter of the City Known 1/8/2013 as the Town of Greenfield.

422 S 2422 Making a Certain Technical Correction to the Charter of the City 1/8/2013 Known as the Town of Greenfield.

423 S 2423 Amending the Charter of the City Known as the Town of 1/8/2013 Greenfield to Make a Certain Technical Correction.

424 S 2424 Making Certain Technical Corrections in the Charter of the City 1/8/2013 Known as the Town of Greenfield Relative to School Committee Officers.

425 S 2426 Amending the Charter of the City Known as the Town of 1/8/2013 Greenfield Relative to the Budget Review Process.

426 S 2429 Amending the Charter of the City Known as the Town of 1/8/2013 Greenfield to Further Regulate the Interdepartmental Transfers of Funds.

427 S 2473 Making Technical Corrections to the Charter of the City Known 1/8/2013 as the Town of Greenfield.

428 S 2480 Amending the Charter of the City Known as the Town of 1/8/2013 Greenfield to Establish a Mayor's Task Force Against Domestic Violence.

429 S 2379 Relative to the Licensure of Behavior Analysts. 1/8/2013

430 H 3637 Designating a Portion of Route 9 from the City of Northampton to 1/8/2013 the City of Pittsfield as the Marine Corps League Highway.

431 H 3948 Relative to Annual Immunization Against Influenza for Children. 1/8/2013

432 H 3959 Relative to Access to Epinephrine in Schools. 1/8/2013

433 H 4252 Providing for a Definintion of Intellectual Disability Consistent 1/8/2013 with the American Association of Intellectual and Developmental Disabilities.

434 H 4296 Relative to Life Settlements and Stranger Originated Life 1/8/2013 Insurance.

435 H 4271 Relative to Certain Retirement Rights. 1/9/2013

436 H 4308 Authorizing the Town of North Andover to Grant an Additional 1/9/2013 License for the Sale of All Alcoholic Beverages not to be Drunk on the Premises.

437 H 4388 Relative to the Leadership and Governance of the City Known as 1/9/2013 the Town of Agawam.

438 H 4535 Establishing a Building Maintenance Fund in the Town of 1/9/2013 Northbridge.

439 H 4551 Making Corrective Changes to Certain Amendments to the Town 1/9/2013 of Southbridge Charter.

440 S 2474 Further Regulating Certain Reimbursements by the City of 1/9/2013 Medford to the Water Enterprise Fund.

441 H 1609 Designating a Certain Bridge in the Town of Newbury as the 1/9/2013 John B. Hayden Bridge.

442 H 3936 Providing Retirement Benefits for a Member of the Franklin 1/9/2013 Regional Retirement System.

443 H 3832 Relative to Vacancies in the Office of Selectmen in the Town of 1/9/2013 North Andover.

444 S 1904 Protecting Lakes and Ponds from Aquatic Nuisances. 1/9/2013

445 S 2168 Establishing the Fire Prevention Regulations Appeals Board. 1/9/2013

446 S 2371 Protecting Public Water Supply Lands. 1/9/2013

447 H 4270 Relative to the Filing of Statements of Financial Condition by 1/9/2013 Public Employee Retirement Systems.

448 S 1985 Further Regulating Dam Safety, Repair and Removal. 1/9/2013

449 H 4175 Authorizing the Orleans, Brewster and Eastham Groundwater 1/9/2013 Protection District to Provide Retirement Benefits for District Employees.

450 H 4506 Designating a Certain Bridge in the City of Fall River as the Army 1/9/2013 Specialist Scott A. Andrews Memorial Bridge.

451 H 4527 Relative to Health and Life Insurance Coverage for Certain 1/9/2013 Elected Officials in the West Barnstable Fire District.

452 H 4485 Relative to the Insurance Contributions of Elected Officials in the 1/9/2013 Cotuit Fire District.

453 S 2368 Exempting Certain Positions in the Town of Milton from the Civil 1/10/2013 Service Law.

454 S 2475 Establishing a Sick Leave Bank for Sarah Bok, an Employee of 1/10/2013 the Trial Court.

455 H 4530 Establishing a 5-Member Board of Health in the City of Methuen. 1/10/2013

456 H 4547 Relative to the Position of Collector and Clerk-Treasurer in the 1/10/2013 Town of South Hadley.

457 H 4473 Relative to the Charter of the Town of Chatham. 1/10/2013

458 H 4548 Establishing a Selectboard-Town Administrator Form of 1/10/2013 Government for the Town of South Hadley.

459 H 4307 Relative to Background Checks. 1/10/2013

460 H 4552 Relative to the Town of Dartmouth Fire District No. 1. 1/10/2013

461 H 4553 Increasing the Membership of the Permanent Commission on 1/10/2013 the Status of Grandparents Raising Grandchildren.

462 S 2386 To Ensure Transparency of Workforce Participation in Public 1/10/2013 Construction Contracts.

463 S 2302 Authorizing the Town of Burlington to Grant Retroactive 1/10/2013 Abatements for Certain Taxes to Certain Military Personnel.

464 H 4561 Relative to the Medical Loss Ratio. 1/11/2013

1 H 4261 Relating to the Tribal-State Compact Between the Mashpee 7/30/2012 Wampanoag Tribe and the Commonwealth of Massachusetts.

Marion Handy, Caleb House and Tavern PR 11/9/2012 152 Front St

Nantucket Fire Hose Cart House #7 and # 10 PR 12/17/2012 8 Gardner St

Rowley Bradstreet Farm PR 12/28/2012 5 239 Main St

Wilmington Boutell-Hathorn House PR 12/17/2012 10 280 Woburn St

Two Boylston Street, Boston, lvlA 02116 617-988-3100 • Fax617-727-7662 www.mass.go1J/ chia ARON BOROS Executive Director

114.2 CMR 4.00 Resident Care Facilities 114.2 CMR 6.00 Standard Payments to Nursing Facilities

The Center for Health Information and Analysis is revising the due dates for the 2012 nursing facility and resident care facility cost reports. The following reports will be due May 1, 2013:

HCF-1: Nursing Facility HCF-2-NH: Realty Company (Nursing Facility) HCF-2-RH: Realty Company (Resident Care Facility) HCF-3 Management Company HCF-4: Resident Care Facility

If you have questions regarding this bulletin, please contact the Provider Assistance line at (617) 988-3297.

7. . : II I 8I ! r £1ill

DEVAL L. PATRICK Governor

TIMOTHY P. MURRAY Lieutenant Governor

JUDYANN BIGBY, M.D. Secretarv

Under authority of Regulation 114.3 CMR 14.01 (5), the Executive Office of Health and Human Services (EOHHS) is adding 35 codes and deleting 10 codes of general dental service as specified in the HCPCS Level II Current Dental Terminology 2012-2013 set by the American Dental Association for the calendar year 2013. The changes below are effective January 1, 2013.

All codes in this bulletin that require pricing are reimbursed at individual consideration (I.C.). Rates listed in this informational bulletin are applicable until revised rates are issued by EOHHS. Deleted codes will no longer be available for use after 2012.

Added Code New EPSDT New Allowed Description Rate Fee 00190 I.C. I.C. Screening of patient 00191 I.C. I.C. Assessment of patient 00364 I.C. I.C. cone beam CT capture and interpretation with limited field of view - less than one whole jaw 00365 I.C. I.C. cone beam CT capture and interpretation with field of view of one full dental arch - mandible 00366 I.C. I.C. cone beam CT capture and interpretation with field of view of one full dental arch - maxilla, with or without cranium 00367 I.C. I.C. cone beam CT capture and interpretation with field of view of both jaws, with or without cranium 00368 I.C. I.C. cone beam CT capture and interpretation for TMJ series including two or more exposures 00369 I.C. I.C. maxillofacial MRI capture and interpretation 00370 I.C. I.C. maxillofacial ultrasound capture and interpretation 00371 I.C. I.C. sialoendoscopy capture and interpretation 00380 I.C. I.C. cone beam CT image capture with

Deleted EPSDT Rate Allowed Fee Description Code 00360 I.C. I.C. cone beam CT - craniofacial data capture 00362 I.C. I.C. cone beam - two-dimensional image reconstruction using existing data, includes multiple imaQes 01203 n/a $29 Topical application of fluoride - child 01204 $26 n/a Topical application of fluoride - adult 04271 $704 $518 free soft tissue graft procedure (including donor site surgery) 06970 $408 $357 post and core in addition to fixed partial denture retainer, indirectly fabricated 06972 $184 $143 prefabricated post and core in addition to fixed partial denture retainer 06973 $160 $126 core build up for retainer, including any pins 06976 I.C. I.C. each additional indirectly fabricated post - same tooth 06977 I.C. I.C. each additional prefabricated post - same tooth

DEVAL L. PATRICK Governor

TIMOTHY P. MURRAY Lieutenant Governor

JUDYANN BIGBY, M.D. SecretaIY

114.3 CMR 6.00: Rates of Payment for Mental Health Services Provided in Community Health Centers and Mental Health Centers

Under the authority of regulation 114.3 CMR 6.03(4), "Coding Updates and Corrections," the Executive Office of Health and Human Services (EOHHS) is adding and deleting certain codes. The deleted codes were cross-walked to the new codes as specified in the calendar year 2013 Centers for Medicare & Medicaid Services Fee Schedule Test Codes and Final Payment Determinations ..

Rates listed in this informational bulletin are applicable until revised rates are issued by EOHHS. Deleted codes will no longer be available for use after 2012.

Deleted New Code I Description Rate for Code CMS Cross-walked Crosswalk Code 90801 90791 Psychiatric diagnostic evaluation $85.83 per hour 90801-HA 90791-HA Psychiatric diagnostic evaluation performed $100.85 with a CANS (Children and Adolescent per hour Needs and Strengths) 90804 and 90832 Psychotherapy, 30 minutes with patient $34.84 90816 and/or family member 90804 and 90833 Psychotherapy, 30 minutes with patient $34.84 90816 and/or family member when performed with an evaluation and management service (List separately in addition to the code for primary procedure) 90806 and 90834 Psychotherapy, 45 minutes with patient $69.68 90818 and/or family member 90806 and 90836 Psychotherapy, 45 minutes with patient $69.68 90818 and/or family member when performed with an evaluation and management service (List separately in addition to the code for primary procedure) 90862 90213 Existing Patient Office or Other Outpatient $40.91 per visit visit. (Medication Visit)

DEVAL L. PATRICK Governor

TIMOTHY P. MURRAY Lieut.enant Governor

JUDYANN BIGBY, M.D. SecretarY

114.3 CMR 20.00: Coding Updates for Clinical Laboratory Services

Effective January 1, 2013

Under the authority of regulation 114.3 CMR 20.01 (3), "Coding Updates and Corrections," the Executive Office of Health and Human Services (EOHHS) is adding new procedure codes and deleting outdated codes as specified in the calendar year 2013 Centers for Medicare & Medicaid Services New Clinical Laboratory Fee Schedule Test Codes and Final Payment Determinations. The rates for code additions are priced at 74.67% of the prevailing Medicare fee if available, with the exception of code 81217 which directly replaces deleted code S3820. The rate for code 81217 is paid at the current rate of the deleted code S3820 contained in 114.3 CMR 20.00: Clinical Laboratory Services. The changes below are effective January 1, 2013.

All other codes in this bulletin that require pricing are reimbursed at individual consideration (I.C.). Rates listed in this informational bulletin are applicable until revised rates are issued by EOHHS. Deleted codes will no longer be available for use after 2012.

Code Change Rate Code Description 81201 Addition I.C. APC (adenomatous polyposis coli) (eg, familial adenomatosis polyposis [FAP], attenuated FAP) gene analysis; full gene sequence 81202 Addition I.C. APC (adenomatous polyposis coli) (eg, familial adenomatosis polyposis [FAP], attenuated FAP) gene analvsis; known familial variants 81203 Addition I.C. APC (adenomatous polyposis coli) (eg, familial adenomatosis polyposis [FAP], attenuated FAP) gene analysis; duplication/deletion variants 81217 Addition $385.00 BRCA2 (breast cancer 2) (e.g. hereditary breast and ovarian cancer) gene analysis; full sequence analysis; known familial variant 81235 Addition I.C. EGFR (epidermal growth factor receptor) (eg, non-small cell lung cancer) gene analysis, common variants (e.g., exon 19 LREA deletion, L858R, T790M, G719A, G719S, L861 Q) 81252 Addition I.C. GJB2 (gap junction protein, beta 2, 26kDa, connexin 30) (e.g., nonsyndromic hearing loss) gene analysis; full gene analysis 81253 Addition I.C. GJB2 (gap junction protein, beta 2, 26kDa, connexin 30) (e.g., nonsyndromic hearing loss) gene analysis; known familial variants 81254 Addition I.C. GJB6 (gap junction protein, beta 6, 30kDa, connexin 30)

The text of the regulations published in the electronic version of the Massachusetts Register is unofficial and for informational purposes only. The official version is the printed copy which is available from the State Bookstore at http://www.sec.state.ma.us/spr/sprcat/catidx.htm. (e.g, nonsyndromic hearing loss), gene analysis, common variants (eg, 309kb [del(GJB6-D13S1830)] and 232kb [del(GJB6-D13S1854)]) 81321 Addition I.C. PTEN (phosphatase and tensin homolog) (e.g., Cowden syndrome, PTEN hamartoma tumor syndrome) gene analysis; full sequence analysis 81322 Addition I.C. PTEN (phosphatase and tensin homolog) (e.g., Cowden syndrome, PTEN hamartoma tumor syndrome) gene analysis; known familial variant 81323 Addition I.C. PTEN (phosphatase and tensin homolog) (e.g., Cowden syndrome, PTEN hamartoma tumor syndrome) gene analysis; duplication/ deletion analysis 81324 Addition I.C. PMP22 (peripheral myelin protein 22) (e.g., Charcot-Marie- Tooth, hereditary neuropathy with liability to pressure palsies) gene analysis; duplication/deletion analysis 81325 Addition I.C. PMP22 (peripheral myelin protein 22) (e.g., Charcot-Marie- Tooth, hereditary neuropathy with liability to pressure palsies) Qene analysis; full sequence analysis 81326 Addition I.C. PMP22 (peripheral myelin protein 22) (e.g., Charcot-Marie- Tooth, hereditary neuropathy with liability to pressure palsies) gene analysis; known familial variant 81479 Addition I.C. Unlisted molecular patholoQy procedure 81500 Addition I.C. Oncology (ovarian), biochemical assays of two proteins (CA- 125 and HE4), utilizing serum, with menopausal status, algorithm reported as risk score 81503 Addition I.C. Oncology (ovarian), biochemical assays of five proteins (CA- 125, apoliproprotein A 1, beta-2 microglobulin, transferring, pre-albumin), utilizing serum, algorithm reported as a risk score 81506 Addition I.C. Endocrinology (type 2 diabetes), biochemical assays of seven analytes (glucose, HbA1c, insulin, hs-CRP, adoponectin, ferritin, interleukin 2-receptor alpha), utilizing serum or plasma, algorithm reportinq a risk score 81508 Addition I.C. Fetal congenital abnormalities, biochemical assays of two proteins (PAPP-A, hCG [any form]), utilizing maternal serum, algorithm reported as a risk score 81509 Addition I.C. Fetal congenital abnormalities, biochemical assays of three proteins (PAPP-A, hCG [any form], DIA), utilizing maternal serum, alQorithm reported as a risk score 81510 Addition I.C. Fetal congenital abnormalities, biochemical assays of three analytes (AFP, uE3, hCG [any form]), utilizing maternal serum, algorithm reported as a risk score 81511 Addition I.C. Fetal congenital abnormalities, biochemical assays of four analytes (AFP, uE3, hCG [any form], DIA), utilizing maternal serum, algorithm reported as a risk score (may include additional results from previous biochemical testing) 81512 Addition I.C. Fetal congenital abnormalities, biochemical assays of five analytes (AFP, uE3, hCG [any form], hyperglycosylated hCG, DIA), utilizing maternal serum, algorithm reported as a risk score 81599 Addition I.C. Unlisted multianalyte assay with alQorithmic analysis 82777 Addition $13.29 Galectin-3 83890 Deletion - - Molecular diagnostics; molecular isolation or extraction, each nucleic acid type (i.e., DNA or RNA) 83891 Deletion - - Molecular diagnostics; isolation or extraction of highly purified nucleic acid, each nucleic acid type (i.e., DNA or

The text of the regulations published in the electronic version of the Massachusetts Register is unofficial and for informational purposes only. The official version is the printed copy which is available from the State Bookstore at http://www.sec.state.ma.us/spr/sprcat/catidx.htm. RNA) 83892 Deletion - - Molecular diagnostics; enzymatic digestion, each enzyme treatment 83893 Deletion - - Molecular diagnostics; dot/slot blot production, each nucleic acid preparation 83894 Deletion - - Molecular diagnostics; separation by gel electrophoresis (e.g., agarose, polyacrylamide), each nucleic acid preparation 83896 Deletion - - Molecular diagnostics; nucleic acid probe, each 83897 Deletion - - Molecular diagnostics; nucleic acid transfer (e.g., Southern, Northern), each nucleic acid preparation 83898 Deletion - - Molecular diagnostics; amplification, target, each nucleic acid sequence 83900 Deletion - - Molecular diagnostics; amplification, target, multiplex, first 2 nucleic acid sequences 83901 Deletion - - Molecular diagnostics; amplification, target, multiplex, each additional nucleic acid sequence beyond 2 (List separately in addition to code for primary procedure) 83902 Deletion - - Molecular diaQnostics; reverse transcription 83903 Deletion - - Molecular diagnostics; mutation scanning, by physical properties (e.g., single strand conformational polymorphisms [SSCP] heteroduplex, denaturing gradient gel electrophoresis ([DGGEl, RNA'ase A), single segment, each 83904 Deletion - - Molecular diagnostics; mutation identification by sequencinQ, sinQle seQment, each segment 83905 Deletion - - Molecular diagnostics; mutation identification by allele specific transcription, single segment, each segment 83906 Deletion - - Molecular diagnostics; mutation identification by allele specific translation, sinQle segment, each seQment 83907 Deletion - - Molecular diagnostics; lysis of cells prior to nucleic acid extraction (e.g., stool specimens, paraffin, embedded tissue), each specimen 83908 Deletion - - Molecular diagnostics; amplification, signal, each nucleic acid sequence 83909 Deletion - - Molecular diagnostics; separation and identification by high resolution technique (e.g., capillary electrophoresis), each nucleic acid preparation 83912 Deletion - - Molecular diaQnostics; interpretation and report 83913 Deletion - - Molecular diagnostics; RNA stabilization 83914 Deletion - - Mutation identification by enzymatic ligation or primer extension, single segment, each segment (e.g., oligonucleotide ligation assay [OLA], single base chain extension [SBCEl, or allele-specific primer extension 86152 Addition I.C. Cell enumeration using immunologic selection and identification in fluid specimen (e.g., circulation tumor cells in blood); 86153 Addition I.C. Cell enumeration using immunologic selection and identification in fluid specimen (e.g., circulation tumor cells in blood); physician interpretation and report 86711 Addition $14.78 Antibody; JC (John CunninQham) virus 86828 Addition $40.62 Antibody to human leukocyte antigens (HLA), solid phase assays (e.g., microspheres or beads, ELISA, flow cytometry); qualitative assessment of the presence or absence of antibody(ies) to HLA Class I and Class II HLA antiQens

The text of the regulations published in the electronic version of the Massachusetts Register is unofficial and for informational purposes only. The official version is the printed copy which is available from the State Bookstore at http://www.sec.state.ma.us/spr/sprcat/catidx.htm. 86829 Addition $30.47 Antibody to human leukocyte antigens (HLA), solid phase assays (e.g., microspheres or beads, ELISA, flow cytometry); qualitative assessment of the presence or absence of antibody(ies) to HLA Class I or Class II HLA antigens 86830 Addition $82.27 Antibody to human leukocyte antigens (HLA), solid phase assays (e.g., microspheres or beads, ELISA, flow cytometry); antibody identification by qualitative panel using complete HLA phenotypes; HLA Class I 86831 Addition $70.52 Antibody to human leukocyte antigens (HLA), solid phase assays (e.g., microspheres or.beads, ELISA, flow cytometry); antibody identification by qualitative panel using complete HLA phenotypes; HLA Class II 86832 Addition $129.28 Antibody to human leukocyte antigens (HLA), solid phase assays (e.g., microspheres or beads, ELISA, flow cytometry); high definition qualitative panel for identification of antibody specificities (e.g., individual antigen per bead methodology), HLA Class I 86833 Addition Antibody to human leukocyte antigens (HLA), solid phase $117.53 assays (e.g., microspheres or beads, ELISA, flow cytometry); high definition qualitative panel for identification of antibody specificities (e.g., individual antigen per bead methodoloQY), HLA Class II 86834 Addition $364.34 Antibody to human leukocyte antigens (HLA), solid phase assays (e.g., microspheres or beads, ELISA, flow cytometry); semi-qualitative panel (e.g., titer), HLA Class I 86835 Addition $329.09 Antibody to human leukocyte antigens (HLA), solid phase assays (e.g., microspheres or beads, ELISA, flow cytometry); semi-qualitative panel (e.g., titer), HLA Class II 87631 Addition $77.76 Infectious agent detection by nucleic acid (DNA or RNA); respiratory virus (e.g., adenovirus, influenza virus, coronavirus, metapneumovirus, parainfluenza virus, respiratory syncytial virus, rhinovirus), multiplex reverse transcription and amplified probe technique, multiple types and subtypes, 3-5 targets 87632 Addition $117.90 Infectious agent detection by nucleic acid (DNA or RNA); respiratory virus (e.g., adenovirus, influenza virus, coronavirus, metapneumovirus, parainfluenza virus, respiratory syncytial virus, rhinovirus), multiplex reverse transcription and amplified probe technique, multiple types and subtypes, 6-11 targets 87633 Addition $218.26 Infectious agent detection by nucleic acid (DNA or RNA); respiratory virus (e.g., adenovirus, influenza virus, coronavirus, metapneumovirus, parainfluenza virus, respiratory syncytial virus, rhinovirus), multiplex reverse transcription and amplified probe technique, multiple types and subtypes, 12-25 targets 87910 Addition $84.44 Infectious agent genotype analysis by nucleic acid (DNA or RNA); ctyomegalovirus 87912 Addition $84.44 Infectious agent genotype analysis by nucleic acid (DNA or RNA); Hepitatis 8 virus

DEVAL 1. PATRICK Governor

TIMOTHY P. MURRAY Lieutenant Governor

,JUDYANN BfGBY, M.D. Secretarv

CPT/HCPCS 2013 Coding Updates for 114.3 CMR 16.00: Surgery and Anesthesia Services 114.3 CMR 17.00: Medicine 114.3 CMR 18.00: Radiology

In accordance with 114.3 CMR 16.01 (4), 17.01 (4), and 18.01 (4), the following coding changes are effective on January 1, 2013. The following list specifies those codes that are added and codes that are deleted, with crosswalks to new codes that replace corresponding deleted codes. New codes with RVUs are reimbursed at rates calculated using the current MassHealth conversion factor. Codes with one-to-one crosswalks to deleted codes are reimbursed at the current payment rate of the deleted codes. Codes with one-to-one crosswalks to existing codes are reimbursed at the current payment rate of the existing codes. For codes with multiple crosswalks, rates for the 2013 additions are calculated according to the rate methodology used in setting physician rates. All other codes in this bulletin that require pricing are reimbursed at individual consideration (I.C.). Rates listed in this informational bulletin are applicable until revised rates are issued by the Executive Office of Health and Human Services (EOHHS). Deleted codes will no longer be available for use after 2012.

Code Description 22586 Arthrodesis, pre-sacral interbody technique, including disc space preparation, discectomy, with posterior instrumentation, with image guidance, includes bone graft when performed, L5-S1 interspace 23473 Revision of total shoulder arthroplasty, including allograft when performed; humeral or glenoid component 23474 Revision of total shoulder arthroplasty, including allograft when performed; humeral and glenoid component 24370 Revision of total elbow arthroplasty, including allograft when performed; humeral or ulnar component 24371 Revision of total elbow arthroplasty, including allograft when performed; humeral and ulnar component 31647 Bronchoscopy, rigid or flexible, including fluoroscopic guidance, when performed; with balloon occlusion, when performed, assessment of air leak, airway sizing, and insertion of bronchial valve(s), initial lobe 31648 Bronchoscopy, rigid or flexible, including fluoroscopic guidance, when performed; with removal of bronchial valve(s), initial lobe 31649 Bronchoscopy, rigid or flexible, including fluoroscopic guidance, when performed; with removal of bronchial valve(s), each additional lobe (List separately in addition to code

The text of the regulations published in the electronic version of the Massachusetts Register is unofficial and for informational purposes only. The official version is the printed copy which is available from the State Bookstore at http://www.sec.state.ma.us/spr/sprcat/catidx.htm. Code Description for primary procedure) 31651 Bronchoscopy, rigid or flexible, including fluoroscopic guidance, when performed; with balloon occlusion, when performed, assessment of air leak, airway sizing, and insertion of bronchial valve(s), each additional lobe (List separately in addition to code for primary procedure[s]) 31660 Bronchoscopy, rigid or flexible, including fluoroscopic guidance, when performed; with bronchial thermoplasty, 1 lobe 31661 Bronchoscopy, rigid or flexible, including fluoroscopic guidance, when performed; with bronchial thermoplasty, 2 or more lobes 32554 Thoracentesis, needle or catheter, aspiration of the pleural space; without imaging Quidance 32555 Thoracentesis, needle or catheter, aspiration of the pleural space; with imaging guidance 32556 Pleural drainage, percutaneous, with insertion of indwelling catheter; without imaging guidance 32557 Pleural drainage, percutaneous, with insertion of indwelling catheter; with imaging guidance 32701 Thoracic target(s} delineation for stereotactic body radiation therapy (SRS/SBRT), (photon or particle beam), entire course of treatment 33361 Transcatheter aortic valve replacement (TAVRITAVI) with prosthetic valve; percutaneous femoral artery approach 33362 Transcatheter aortic valve replacement (TAVRITAVI) with prosthetic valve; open femoral artery approach 33363 Transcatheter aortic valve replacement (TAVRITAVI) with prosthetic valve; open axillary artery approach 33364 Transcatheter aortic valve replacement (TAVRIT AVI) with prosthetic valve; open iliac artery approach 33365 Transcatheter aortic valve replacement (TAVRIT AVI) with prosthetic valve; transaortic approach (eg, median sternotomy, mediastinotomy) 33367 Transcatheter aortic valve replacement (TAVRITAVI) with prosthetic valve; cardiopulmonary bypass support with percutaneous peripheral arterial and venous cannulation (eg, femoral vessels) (List separately in addition to code for primary procedure) 33368 Transcatheter aortic valve replacement (TAVRITAVI) with prosthetic valve; cardiopulmonary bypass support with open peripheral arterial and venous cannulation (eg, femoral, iliac, axillary vessels) (List separately in addition to code for primary procedure) 33369 Transcatheter aortic valve replacement (TAVRITAVI) with prosthetic valve; cardiopulmonary bypass support with central arterial and venous cannulation (eg, aorta, right atrium, pulmonary artery) (List separately in addition to code for primary procedure) 33990 Insertion of ventricular assist device, percutaneous including radiological supervision and interpretation; arterial access only 33991 Insertion of ventricular assist device, percutaneous including radiological supervision and interpretation; both arterial and venous access, with transseptal puncture 33992 Removal of percutaneous ventricular assist device at separate and distinct session from insertion 33993 Repositioning of percutaneous ventricular assist device with imaging guidance at separate and distinct session from insertion 36221 Non-selective catheter placement, thoracic aorta, with angiography of the extracranial carotid, vertebral, and/or intracranial vessels, unilateral or bilateral, and all associated radiological supervision and interpretation, includes angiography of the cervicocerebral arch, when performed 36222 Selective catheter placement, common carotid or innominate artery, unilateral, any

The text of the regulations published in the electronic version of the Massachusetts Register is unofficial and for informational purposes only. The official version is the printed copy which is available from the State Bookstore at http://www.sec.state.ma.us/spr/sprcat/catidx.htm. Code Descri tion approach, with angiography of the ipsilateral extracranial carotid circulation and all associated radiological supervision and interpretation, includes angiography of the cervicocerebral arch, when erformed 36223 Selective catheter placement, common carotid or innominate artery, unilateral, any approach, with angiography of the ipsilateral intracranial carotid circulation and all associated radiological supervision and interpretation, includes angiography of the extracranial carotid and cervicocerebral arch, when erformed 36224 Selective catheter placement, internal carotid artery, unilateral, with angiography of the ipsilateral intracranial carotid circulation and all associated radiological supervision and interpretation, includes angiography of the extracranial carotid and cervicocerebral arch, when erformed 36225 Selective catheter placement, subclavian or innominate artery, unilateral, with angiography of the ipsilateral vertebral circulation and all associated radiological supervision and interpretation, includes angiography of the cervicocerebral arch, when erformed 36226 Selective catheter placement, vertebral artery, unilateral, with angiography of the ipsilateral vertebral circulation and all associated radiological supervision and inter retation, includes an io ra h of the cervicocerebral arch, when erformed 36227 Selective catheter placement, external carotid artery, unilateral, with angiography of the ipsilateral external carotid circulation and all associated radiological supervision and interpretation List se aratel in addition to code for rima procedure 36228 Selective catheter placement, each intracranial branch of the internal carotid or vertebral arteries, unilateral, with angiography of the selected vessel circulation and all associated radiological supervision and interpretation (eg, middle cerebral artery, posterior inferior cerebellar artery) (List separately in addition to code for primary procedure) 37197 Transcatheter retrieval, percutaneous, of intravascular foreign body (eg, fractured venous or arterial catheter), includes radiological supervision and interpretation, and ima in uidance ultrasound or fluorosco , when erformed 37211 Transcatheter therapy, arterial infusion for thrombolysis other than coronary, any method, includin radiolo ical su ervision and inter retation, initial treatment da 37212 Transcatheter therapy, venous infusion for thrombolysis, any method, including radiolo ical su ervision and inter retation, initial treatment da 37213 Transcatheter therapy, arterial or venous infusion for thrombolysis other than coronary, any method, including radiological supervision and interpretation, continued treatment on subsequent day during course of thrombolytic therapy, including follow-up catheter contrast in"ection, osition chan e, or exchan e, when erformed; 37214 Transcatheter therapy, arterial or venous infusion for thrombolysis other than coronary, any method, including radiological supervision and interpretation, continued treatment on subsequent day during course of thrombolytic therapy, including follow-up catheter contrast injection, position change, or exchange, when performed; cessation of thrombol sis includin removal of catheter and vessel closure b an method 38243 Hemato oietic ro enitor cell HPC; HPC boost 43206 Eso ha oscop , ri id or flexible; with optical endomicroscop 43252 Upper gastrointestinal endoscopy including esophagus, stomach, and either the duodenum and/or "e"unum as a ropriate; with 0 tical endomicrosco 44705 Pre aration of fecal microbiota for instillation, includin assessment of donor s ecimen 52287 C stourethrosco , with in"ection s for chemodenervation of the bladder 64615 Chemodenervation of muscle(s); muscle(s) innervated by facial, trigeminal, cervical sinal and accesso nerves, bilateral (e , for chronic mi raine 88375 Optical endomicroscopic image(s), interpretation and report, real-time or referred, each endosco ic session

31715 32420 32421 32422

37201 37203

37209 43234

83912 88384 88385 88386

Replacement Deleted Codes Codes 31656,31715 31899 32420 32405 32421,32422 32554-32555 37201,37209 37211-37214 37203 37197 43234 43235 65805 65800

NFAC FAC TC Code Fee Fee Global PC Fee Fee 22586 - - - - $1,154.58 - - - - 23473 - - - - $1,261.30 - - - - 23474 - - - - $1,361.34 - - - - 24370 - - - - $1,194.03 - - - - 24371 - - - - $1,374.51 - - - - 31647 - - - - $171.98 - - - - 31648 - - - - $180.98 - - - - 31649 - - - - $57.27 - - - - 31651 - - - - $60.52 - - - - 31660 - - - - $173.05 - - - -

The text of the regulations published in the electronic version of the Massachusetts Register is unofficial and for informational purposes only. The official version is the printed copy which is available from the State Bookstore at http://www.sec.state.ma.us/spr/sprcat/catidx.htm. Code Descri tion 90653 Influenza vaccine, inactivated, subunit, ad"uvanted, for intramuscular use 90672 Influenza virus vaccine, uadrivalent, live, for intranasal use 90685 Influenza virus vaccine, quadrivalent, split virus, preservative free, when administered to children 6-35 months of a e, for intramuscular use Influenza virus vaccine, quadrivalent, split virus, preservative free, when administered to individuals 3 ears of a e and older, for intramuscular use Influenza virus vaccine, quadrivalent, split virus, when administered to children 6-35 months of a e, for intramuscular use Influenza virus vaccine, quadrivalent, split virus, when administered to individuals 3 ears of a e and older, for intramuscular use 90739 He atitis B vaccine, adult dosa e 2 dose schedule, for intramuscular use 90785 Interactive com lexit List se aratel in addition to the code for rocedure 90791 Ps chiatric dia nostic evaluation 90792 Ps chiatric dia nostic evaluation with medical services 90832 Ps chothera ,30 minutes with atient and/or famil member 90833 Psychotherapy, 30 minutes with patient and/or family member when performed with an evaluation and management service (List separately in addition to the code for primary rocedure) 90834 Ps chothera ,45 minutes with atient and/or famil member 90836 Psychotherapy, 45 minutes with patient and/or family member when performed with an evaluation and management service (List separately in addition to the code for primary rocedure 90837 Ps chothera ,60 minutes with patient and/or famil member 90838 Psychotherapy, 60 minutes with patient and/or family member when performed with an evaluation and management service (List separately in addition to the code for primary rocedure 90839 Ps chothera for crisis; first 60 minutes 90840 Psychotherapy for crisis; each additional 30 minutes (List separately in addition to code for rimar service Pharmacologic management, including prescription and review of medication, when performed with psychotherapy services (List separately in addition to the code for primar procedure Gastrointestinal transit and pressure measurement, stomach through colon, wireless capsule, with interpretation and re ort Gastrointestinal transit and pressure measurement, stomach through colon, wireless ca sule, with inter retation and re ort Gastrointestinal transit and pressure measurement, stomach through colon, wireless ca sule, with inter retation and re ort Percutaneous transluminal coronary angioplasty; single major coronary artery or branch Percutaneous transluminal coronary angioplasty; each additional branch of a major coronar arter List se aratel in addition to code for rima rocedure Percutaneous transluminal coronary atherectomy, with coronary angioplasty when erformed; sin Ie ma"or coronar arter or branch Percutaneous transluminal coronary atherectomy, with coronary angioplasty when performed; each additional branch of a major coronary artery (List separately in addition to code for rimar procedure Percutaneous transcatheter placement of intracoronary stent(s), with coronary an io last when erformed; sin Ie ma"or coronar arter or branch

The text of the regulations published in the electronic version of the Massachusetts Register is unofficial and for informational purposes only. The official version is the printed copy which is available from the State Bookstore at http://www.sec.state.ma.us/spr/sprcat/catidx.htm. Code Descri tion 92929 Percutaneous transcatheter placement of intracoronary stent(s), with coronary angioplasty when performed; each additional branch of a major coronary artery (List separatel in addition to code for rimar rocedure Percutaneous transluminal coronary atherectomy, with intracoronary stent, with coronar an io last when performed; sin Ie ma"or corona arte or branch Percutaneous transluminal coronary atherectomy, with intracoronary stent, with coronary angioplasty when performed; each additional branch of a major coronary arter (List separatel in addition to code for rimar procedure Percutaneous transluminal revascularization of or through coronary artery bypass graft (internal mammary, free arterial, venous), any combination of intracoronary stent, atherectomy and angioplasty, including distal protection when performed; single vessel Percutaneous transluminal revascularization of or through coronary artery bypass graft (internal mammary, free arterial, venous), any combination of intracoronary stent, atherectomy and angioplasty, including distal protection when performed; each additional branch subtended by the bypass graft (List separately in addition to code for rimar rocedure Percutaneous transluminal revascularization of acute total/subtotal occlusion during acute myocardial infarction, coronary artery or coronary artery bypass graft, any combination of intracoronary stent, atherectomy and angioplasty, including aspiration thrombectom when erformed, sin Ie vessel Percutaneous transluminal revascularization of chronic total occlusion, coronary artery, coronary artery branch, or coronary artery bypass graft, any combination of intracorona stent, atherectom and an io last ; sin Ie vessel Percutaneous transluminal revascularization of chronic total occlusion, coronary artery, coronary artery branch, or coronary artery bypass graft, any combination of intracoronary stent, atherectomy and angioplasty; each additional coronary artery, coronary artery branch, or bypass graft (List separately in addition to code for primary rocedure Comprehensive electrophysiologic evaluation including insertion and repositioning of multiple electrode catheters with induction or attempted induction of an arrhythmia with right atrial pacing and recording, right ventricular pacing and recording, His recording with intracardiac catheter ablation of arrhythmogenic focus; with treatment of supraventricular tachycardia by ablation of fast or slow atrioventricular pathway, accessory atrioventricular connection, cavo-tricuspid isthmus or other single atrial focus or source of atrial re-entr Comprehensive electrophysiologic evaluation including insertion and repositioning of multiple electrode catheters with induction or attempted induction of an arrhythmia with right atrial pacing and recording, right ventricular pacing and recording, His recording with intracardiac catheter ablation of arrhythmogenic focus; with treatment of ventricular tachycardia or focus of ventricular ectopy including intracardiac electrophysiologic 3D mapping, when performed, and left ventricular pacing and recordin ,when erformed Intracardiac catheter ablation of a discrete mechanism of arrhythmia which is distinct from the primary ablated mechanism, including repeat diagnostic maneuvers, to treat a spontaneous or induced arrhythmia (List separately in addition to code for primary rocedure Comprehensive electrophysiologic evaluation including transseptal catheterizations, insertion and repositioning of multiple electrode catheters with induction or attempted induction of an arrhythmia with atrial recording and pacing, when possible, right ventricular pacing and recording, His bundle recording with intracardiac catheter ablation of arrhythmogenic focus, with treatment of atrial fibrillation by ablation by ulmonar vein isolation

The text of the regulations published in the electronic version of the Massachusetts Register is unofficial and for informational purposes only. The official version is the printed copy which is available from the State Bookstore at http://www.sec.state.ma.us/spr/sprcat/catidx.htm. Code Description 93657 Additional linear or focal intracardiac catheter ablation of the left or right atrium for treatment of atrial fibrillation remaining after completion of pulmonary vein isolation (List separately in addition to code for primary procedure) 95017 Allergy testing, any combination of percutaneous (scratch, puncture, prick) and intracutaneous (intradermal), sequential and incremental, with venoms, immediate type reaction, inciudinQ test interpretation and report, specify number of tests 95018 Allergy testing, any combination of percutaneous (scratch, puncture, prick) and intracutaneous (intradermal), sequential and incremental, with drugs or biologicals, immediate type reaction, including test interpretation and report, specify number of tests 95076 Ingestion challenge test (sequential and incremental ingestion of test items, eg, food, drug or other substance); initial 120 minutes of testinQ 95079 Ingestion challenge test (sequential and incremental ingestion of test items, eg, food, drug or other substance); each additional 60 minutes of testing (List separately in addition to code for primary procedure) 95782 Polysomnography; younger than 6 years, sleep staging with 4 or more additional parameters of sleep, attended by a technoloQist 95782 Polysomnography; younger than 6 years, sleep staging with 4 or more additional parameters of sleep, attended by a technoloqist 95782 Polysomnography; younger than 6 years, sleep staging with 4 or more additional parameters of sleep, attended by a technologist 95783 Polysomnography; younger than 6 years, sleep staging with 4 or more additional parameters of sleep, with initiation of continuous positive airway pressure therapy or bi-Ievel ventilation, attended by a technoloqist 95783 Polysomnography; younger than 6 years, sleep staging with 4 or more additional parameters of sleep, with initiation of continuous positive airway pressure therapy or bi-Ievel ventilation, attended by a technologist 95783 Polysomnography; younger than 6 years, sleep staging with 4 or more additional parameters of sleep, with initiation of continuous positive airway pressure therapy or bi-Ievel ventilation, attended by a technoloQist 95907 Nerve conduction studies; 1-2 studies 95907 Nerve conduction studies; 1-2 studies 95907 Nerve conduction studies; 1-2 studies 95908 Nerve conduction studies; 3-4 studies 95908 Nerve conduction studies; 3-4 studies 95908 Nerve conduction studies; 3-4 studies 95909 Nerve conduction studies; 5-6 studies 95909 Nerve conduction studies; 5-6 studies 95909 Nerve conduction studies; 5-6 studies 95910 Nerve conduction studies; 7-8 studies 95910 Nerve conduction studies; 7-8 studies 95910 Nerve conduction studies; 7-8 studies 95911 Nerve conduction studies; 9-10 studies 95911 Nerve conduction studies; 9-10 studies 95911 Nerve conduction studies; 9-10 studies 95912 Nerve conduction studies; 11-12 studies 95912 Nerve conduction studies; 11-12 studies 95912 Nerve conduction studies; 11-12 studies 95913 Nerve conduction studies; 13 or more studies 95913 Nerve conduction studies; 13 or more studies

The text of the regulations published in the electronic version of the Massachusetts Register is unofficial and for informational purposes only. The official version is the printed copy which is available from the State Bookstore at http://www.sec.state.ma.us/spr/sprcat/catidx.htm. Code Descri tion 95913 Nerve conduction studies; 13 or more studies 95924 Testing of autonomic nervous system function; combined parasympathetic and s m athetic adrener ic function testin with at least 5 minutes of assive tilt Testing of autonomic nervous system function; combined parasympathetic and s m athetic adrener ic function testin with at least 5 minutes of assive tilt Testing of autonomic nervous system function; combined parasympathetic and s m athetic adrener ic function testin with at least 5 minutes of assive tilt Continuous intraoperative neurophysiology monitoring in the operating room, one on one monitoring requiring personal attendance, each 15 minutes (List separately in addition to code for rimar rocedure Continuous intraoperative neurophysiology monitoring, from outside the operating room (remote or nearby) or for monitoring of more than one case while in the operatin room, er hour List separatel in addition to code for rima rocedure Simultaneous, independent, quantitative measures of both parasympathetic function and sympathetic function, based on time-frequency analysis of heart rate variability concurrent with time-frequency analysis of continuous respiratory activity, with mean heart rate and blood pressure measures, during rest, paced (deep) breathing, Valsalva maneuvers, and head-u ostural chan e Simultaneous, independent, quantitative measures of both parasympathetic function and sympathetic function, based on time-frequency analysis of heart rate variability concurrent with time-frequency analysis of continuous respiratory activity, with mean heart rate and blood pressure measures, during rest, paced (deep) breathing, Valsalva maneuvers, and head-u ostural chan e Simultaneous, independent, quantitative measures of both parasympathetic function and sympathetic function, based on time-frequency analysis of heart rate variability concurrent with time-frequency analysis of continuous respiratory activity, with mean heart rate and blood pressure measures, during rest, paced (deep) breathing, Valsalva maneuvers, and head-u ostural chan e Supervision by a control physician of interfacility transport care of the critically ill or critically injured pediatric patient, 24 months of age or younger, includes two-way communication with transport team before transport, at the referring facility and during the trans ort, includin data inter retation and re ort; first 30 minutes Supervision by a control physician of interfacility transport care of the critically ill or critically injured pediatric patient, 24 months of age or younger, includes two-way communication with transport team before transport, at the referring facility and during the transport, including data interpretation and report; each additional 30 minutes (List separatel in addition to code for rimar procedure) Complex chronic care coordination services; first hour of clinical staff time directed by a physician or other qualified health care professional with no face-to-face visit, per calendar month Complex chronic care coordination services; first hour of clinical staff time directed by a physician or other qualified health care professional with one face-to-face visit, per calendar month Complex chronic care coordination services; each additional 30 minutes of clinical staff time directed by a physician or other qualified health care professional, per calendar month (List se aratel in addition to code for rimar rocedure Transitional Care Management Services with the following required elements: Communication (direct contact, telephone, electronic) with the patient and/or caregiver within 2 business days of discharge Medical decision making of at least moderate complexity during the service period Face-to-face visit, within 14 calendar days of discharge Transitional Care Management Services with the following required elements: Communication (direct contact, telephone, electronic) with the patient and/or caregiver within 2 business days of discharge Medical decision making of high complexity during the service period Face-to-face visit, within 7 calendar da s of dischar e

The text of the regulations published in the electronic version of the Massachusetts Register is unofficial and for informational purposes only. The official version is the printed copy which is available from the State Bookstore at http://www.sec.state.ma.us/spr/sprcat/catidx.htm. Code Description 90665 L me disease vaccine, adult dosa e, for intramuscular use 90701 Diphtheria, tetanus toxoids, and whole cell pertussis vaccine (DTP), for intramuscular use Tetanus and diphtheria toxoids (Td) adsorbed when administered to individuals 7 years or older, for intramuscular use 90801 Ps chiatric dia nostic interview examination 90802 Interactive psychiatric diagnostic interview examination using play equipment, physical devices, Ian ua e interpreter, or other mechanisms of communication Individual psychotherapy, insight oriented, behavior modifying and/or supportive, in an office or out atient facilit ,approximatel 20 to 30 minutes face-to-face with the patient; Individual psychotherapy, insight oriented, behavior modifying and/or supportive, in an office or out atient facilit ,approximatel 45 to 50 minutes face-to-face with the patient; Individual psychotherapy, insight oriented, behavior modifying and/or supportive, in an office or out atient facilit ,ap roximatel 75 to 80 minutes face-to-face with the atient; Individual psychotherapy, interactive, using play equipment, physical devices, language interpreter, or other mechanisms of non-verbal communication, in an office or outpatient facilit ,a roximatel 20 to 30 minutes face-to-face with the atient; Individual psychotherapy, interactive, using play equipment, physical devices, language interpreter, or other mechanisms of non-verbal communication, in an office or out atient facilit ,a roximatel 45 to 50 minutes face-to-face with the atient; Individual psychotherapy, interactive, using play equipment, physical devices, language interpreter, or other mechanisms of non-verbal communication, in an office or outpatient facilit ,a roximatel 75 to 80 minutes face-to-face with the atient; Individual psychotherapy, insight oriented, behavior modifying and/or supportive, in an inpatient hospital, partial hospital or residential care setting, approximately 20 to 30 minutes face-to-face with the atient; Individual psychotherapy, insight oriented, behavior modifying and/or supportive, in an inpatient hospital, partial hospital or residential care setting, approximately 45 to 50 minutes face-to-face with the patient; Individual psychotherapy, insight oriented, behavior modifying and/or supportive, in an inpatient hospital, partial hospital or residential care setting, approximately 75 to 80 minutes face-to-face with the patient; Individual psychotherapy, interactive, using play equipment, physical devices, language interpreter, or other mechanisms of non-verbal communication, in an inpatient hospital, partial hospital or residential care setting, approximately 20 to 30 minutes face-to-face with the patient; Individual psychotherapy, interactive, using play equipment, physical devices, language interpreter, or other mechanisms of non-verbal communication, in an inpatient hospital, partial hospital or residential care setting, approximately 45 to 50 minutes face-to-face with the patient; Individual psychotherapy, interactive, using play equipment, physical devices, language interpreter, or other mechanisms of non-verbal communication, in an inpatient hospital, partial hospital or residential care setting, approximately 75 to 80 minutes face-to-face with the atient; 90857 Interactive rou s chotherap 92980 Transcatheter placement of an intracoronary stent(s), percutaneous, with or without other thera eutic intervention, an method; sin Ie vessel Transcatheter placement of an intracoronary stent(s), percutaneous, with or without other therapeutic intervention, any method; each additional vessel (List separately in addition to code for rimar procedure

Deleted Codes Replacement Codes 90801,90802 90791-90792 90804, 90816 90832 90806, 90818 90834 90808, 90821 90837 90810,90823 90785, 90832 90812, 90826 90785, 90834 90814, 90828 90785, 90837 90857, 92980, 90785, 90853 92981, 92982, 92984 92995 92924, 92933, 92937, 92941,92943 92996 92925, 92934, 92938, 92944 93651,93652 93653-93657

NFAC FAC Code Fee Fee Global PC Fee TC Fee 90653 - - - - I.C. - - - - 90672 - - - - I.C. - - - - 90685 - - - - I.C. - - - - 90686 - - - - I.C. - - - - 90687 - - - - I.C. - - - - 90688 - - - - I.C. - - - - 90739 - - - - I.C. - - - - 90785 - - - - $3.61 - - - - 90791 $117.42 $89.51 ------90792 $95.06 $92.24 ------90832 $48.53 $37.26 ------90833 $31.77 $31.49 ------90834 $61.81 $55.89 ------90836 - - - - $51.58 - - - - 90837 $90.29 $84.37 ------90838 $83.11 $82.83 ------90839 - - - - I.C. - - - - 90840 - - - - I.C. - - - - 90853 $21.81 $23.76 ------90863 - - - - I.C. - - - - 91112 - - - - $978.86 $87.09 $891.77 92920 - - - - $409.13 - - - - 92921 - - - - I.C. - - - - 92924 - - - - $515.61 - - - - 92925 - - - - $137.76 - - - - 92928 - - - - $454.04 - - - - 92929 - - - - I.C. - - - - 92933 - - - - $515.61 - - - - 92934 - - - - $137.76 - - - - 92937 - - - - $515.61 - - - - 92938 - - - - $137.76 - - - - 92941 - - - - $515.61 - - - - 92943 - - - - $515.61 - - - - 92944 - - - - $137.76 - - - - 93653 - - - - $619.52 - - - - 93654 - - - - $826.78 - - - - 93655 - - - - $309.80 - - - -

Code Description 78012 Thyroid uptake, single or multiple quantitative measurement(s) (including stimulation, su ression, or dischar e, when performed) 78013 Th roid ima in includin vascular flow, when erformed; 78014 Thyroid imaging (including vascular flow, when performed); with single or multiple uptake(s) quantitative measurement(s) (including stimulation, suppression, or dischar e, when erformed Parathyroid planar imaging (including subtraction, when performed); with tomographic SPECT) Parathyroid planar imaging (including subtraction, when performed); with tomographic (SPECT), and concurrently acquired computed tomography (CT) for anatomical localization

Code 71040 71060 75650

Deleted Code Replacement Code 71040,71060 76499 75650 36221-36226 75660, 75662 36227 75665, 75671 36223-36224 75676, 75680 36222-36224 75685 36225-36226 75900 37211-37214 75961 37197 78000-78001,78003, 78012-78014 78006-78007,78010- 78011

NFAC PC Code Fee NFAC Global Fee TC Fee 78012 - - - - $68.45 $7.08 $61.37 78013 - - - - $173.29 $13.71 $159.58 78014 - - - - $200.45 $18.32 $182.13 78071 - - - - $297.50 $43.49 $254.01 78072 ------$60.68 - - 76499 - - - - I.C. - - - -

NOTICES OF PUBLIC REVIEW OF PROSPECTIVE REGULATIONS PUBLISHED IN COMPLIANCE WITH M.G.L. c. 30A, SECTIONS 2 AND 3

Published February 01, 2013

Energy and Environmental 301 CMR 4.00 3/11/13, 11:00 A.M. - 2:00 P.M. Affairs, Executive Office of Written testimony accepted until 3/22/13 @ 3/22/13.

Health and Human Services, 101 CMR 420.00 2/26/13 @ 10.00 A.M. Electronic Executive Office for and Written testimony accepted until 3/8/13 @ 5:00 P.M.

Marine Fisheries, Division of 322 CMR 3.00, 6.00, 7.00, 8.00 2/13/13, 5:30 P.M. - 9:30 P.M. & 12.00 Comments accepted until 2/15/13 @ 5:00 P.M.

Public Health, Department of 105 CMR 216.000 2/11/13 @ 11:00 A.M. 2/14/13 @ 1:00 P.M. Testimony accepted until 2/15/13 @ 5:00 P.M.

105 CMR 651.000 2/13/13 @ 2:00 P.M. Testimony due by 2/15/13 @ 5:00 P.M.

Notice is hereby given that the Massachusetts Executive Office of Energy and Environmental Affairs (EEA), under its authority pursuant to M.G.L. c. 94 Section 321 - 326, and in conformance with M.G.L. c.30A, will hold a public hearing on proposed amendments to the Provisions for Recycling of Beverage Containers regulations at 301 CMR 4.00. The proposed change is a revision to 310 CMR 4.05 (4) proposing to change the handling fee for bottles from 2.25 cents/beverage container to 3.25 cents/beverage container.

A public hearing will be conducted on the following date at the following location to receive comments on the proposed revisions. Testimony may be presented orally or in writing at the hearing.

Wednesday, March 11,2013, 11:00 - 2:00 PM 100 Cambridge Street 2nd Floor Conference Room Boston, MA 02114

Written testimony will be accepted from the opening of the comment period on Friday, February 1,2013 until 5 P.M. Friday, March 22,2013. Written testimony should be submitted via email to [email protected] or mailed to: Dan Sieger, Executive Office of Energy and Environmental Affairs, 100 Cambridge Street, Suite 900, Boston, MA 02114. Copies of the proposed regulations are available on the EEA website at http://www.mass.gov/eeal or may be obtained by calling Dan Sieger at 617-626-1172. For special accommodations for this event or to obtain this information in an alternative format, you may contact Barbara Nobles Crawford, Executive Office of Energy and Environmental Affairs, ADA coordinator, at 617-626-1161, 100 Cambridge Street, Suite 900, Boston, MA 02114.

By the order of the Executive Office of Energy and Environmental Affairs Richard K. Sullivan Jr.

Describe the Scope and Objectives of the Regulation: The proposed change to 301 CMR 4.00 would raise the handling fee paid to redemption centers from the current 2.25¢ per beverage container to 3.25¢. This fee is paid to redemption centers by distributors for the acceptance and management of deposit containers received from consumers. The fee has not been raised since 1991. The objective of the change is to raise the fee to better reflect current market conditions.

Types of Businesses Included in the Industry(ies): Redemption Centers, Beer and Soft Drink Manuafacturers/Distributors

Total Number of Small Businesses Included in the Regulated Industry(ies) Please see the attached guidance documentsfor assistance determining the total number ofsmall businesses: 146 Redemption Centers - all Small businesses - This is a combination of stand alone redemption centers(76) and dealers that have also registered as redemption centers (70). 40 BottlerslDistributors.

Number of Small Businesses Potentially Subject to the Proposed Regulation: 186 - 146 redemption centers will benefit - 40-45 small distributors/bottlers will be required to pay a higher handling fee.

Yes No Will small businesses have to create, file, or issue additional reports? 0 ~ Administration of the regulation by EOEEA will not change under the proposed amendment. Procedures currently employed by small business will not change as a result of the proposed amendment

Yes No Will small businesses have to implement addiWt~Hd recordkeeping procedures?

Yes No Will small businesses have to provide additional administrative oversight? 0 ~ Administration of the regulation by EOEEA will not change under the proposed amendment. Procedures and administration currently employed by small business will not change as a result of the proposed amendment

Yes No Will small businesses have to hire additional employees in order to comply with the ~ ~ proposed regulation? Administration of the regulation by EOEEA will not change under the proposed amendment. More redemption centers may be established as a result of the increase in the handling fee and existing redemption centers may hire more people to address an increase in volume. Procedures currently employed by small bottlers/distributors will not change as a result of the proposed amendment therefore no increase in employees will be necessary

Yes No Does compliance with the regulation require small businesses to hire other professionals 0 ~ (e.g. a lawyer, accountant, engineer, etc.)? Administration of the regulation by EOEEA will not change under the proposed amendment. Procedures currently employed by small business will not change as a result of the proposed amendment. No outside professionals will be necessary.

Yes No Does the regulation require small businesses to purchase a product or make any other 0 ~ capital investments in order to comply with the regulation? Administration of the regulation by EOEEA will not change under the proposed amendment. Procedures cUrFently employed by small business will not change as a result ofthe proposed amendment, therefore no new capital investments will be necessary.

Yes No Are performance standards more appropriate than design standards? 0 ~ The proposed change is an amendment to an existing performance standard - the handling fee paid to redemption centers based on each container redeemed.

Yes No Does the regulation require small businesses to cooperate with audits, inspections, or 0 ~ other regulatory enforcement activities? Administration of the regulation by EOEEA will not change under the proposed amendment. Pr-ocedures currently employed by small business will not change as a result of the proposed amendment, therefore no new audits, inspections or other enforcement will be necessary.

Yes No Will the regulation have the effect of creating additional taxes and/or fees for small ~ 0 businesses? A small number of bottlers/distributors (est. 40-45) will be required to pay an increased handling fee to redemption centers. 146 redemption centers will benefit from this increase and the increase may result in the establishment of more redemption centers

Yes No Does the regulation require small businesses to provide educational services to keep up to 0 ~ date with regulatory requirements? N(}, the proposed change does not change administrative aspects of the regulation just the amount of the fee paid by distributors/bottlers to redemption centers.

Yes No Is the regulation likely to encourage the formation of small businesses in Massachusetts? [gI D Yes the proposed change will likely result in the establishment of more redemption centers in Massachusetts as a result of improved economics for redemption centers connected to the handling fee increase.

Yes No Can the regulation provide for less stringent compliance or reporting requirements for D [gI small businesses? Administration of the regulation by EOEEA will not change under the proposed amendment. Procedures currently employed by small business will not change as a result of the proposed amendment

Yes No Can the regulation establish less stringent schedules or deadlines for compliance or D [gI reporting requirements for small businesses? Administration of the regulation by EOEEA will not change under the proposed amendment. Procedures currently employed by small business will not change as a result of the proposed amendment

Yes No Can the compliance or reporting requirements be consolidated or simplified for small D [gI businesses? Administration of the regulation by EOEEA will not change under the proposed amendment. Procedures currently employed by small business will not change as a result of the proposed amendment

Yes No Can performance standards for small businesses replace design or operational standards? D [gI The proposed change is an amendment to an existing performance standard - the handling fee paid to redemption centers based on each container redeemed.

Yes No Are there alternative regulatory methods that would minimize the adverse impact on D [gI small businesses? Administration of the regulation by EOEEA will not change under the proposed amendment. Procedures currently employed by small business will not change as a result of the proposed amendment

Yes No Were any small businesses or small business organizations contacted during the [gI D preparation of this document? If so, please describe. Yes, EOEEA has had extensive conversations with redemption centers, bottlers and beverage distributors with regard to the bottle deposit law and the handling fee.

DEVAL L. PATRICK Govemor

TIMOTHY P. MURRAY Lieutenant Govemor

JUDYANN BIGBY, M.D. Secretary

NOTICE OF PUBLIC HEARING Pursuant to the provisions ofM.G.L. c.118E and in accordance with M.G.L. c. 30A, as amended, a public hearing will be held on Tuesday, February 26, 2013, at 10:00 a.m. at the Hoagland-PincLls Conference Center, University of Massachusetts Medical School, 222 Maple Avenue, Shrewsbury, MA 01545 relative to the adoption of:

This is a new regulation being promulgated by the Executive Office of Health and Human Services (EOHHS) pursuant to c. 257 of the Acts of2008. The proposed regulation governs the payment rates for Adult Long-Term Residential Services purchased by a governmental unit including but not limited to the Department of Developmental Services (DDS), Massachusetts Commission for the Blind (MCB) and Massachusetts Rehabilitation Commission (MRC). The regulation establishes standard per diem rates for programs that provide individuals 24 hours a dayl7 days a week overnight housing for an extended period of time in a specialized residential setting with necessary daily living, physical, social, clinical and/or medical supports. Many individuals attend separate day or work-related programs, but the residential program needs to accommodate the possibility of providing day support in case of illness or other reason. Providers will receive two rates for each model-one related to program resources and the other for the provision of the physical site. The programmatic rates were developed using model budgets that reflect a variety of program sizes, staffing ratios and expertise designed to address the needs of the residents. The purchasing agencies provided the staffing standards for each service model. The cost benchmarks used to develop the rates were based on analysis of contract budget data, other relevant available market data or existing benchmarks from comparable services. All program models reflect consistent salary, staff relief, tax and fringe benefit, and administrative overhead factors. Rates were calculated on a per client per day basis using a productivity factor of 95% and a cost adjustment factor of 3.93%. Standard add-on rates are also proposed to accommodate temporary needs for additional resources. The per diem rates for the physical site portion are based on analysis of data gathered through a specialized provider cost survey conducted for this resource and represent price points along the continuum of unit cost revealed this analysis.

EOHHS is proposing this regulation to ensure that payment rates are consistent with efficiency, economy, and quality of care. The regulation will be effective for procurements issued in FY 2013 and thereafter. The regulation contains a phase in feature that implements half of the estimated increase in rates in FY 2014 and the remainder in rates effective FY 2015. It is anticipated that aggregate annual public expenditures will increase by a total of approximately $53.6 million in fiscal year 2014 and $89.3 million in fiscal year 2015 as a result of this regulation. These increases will be reduced by $20.4 million in federal matching revenue for fiscal year 2014 and $31.1 million for fiscal year 2015.

Individuals that notify EOHHS of their intent to testify at the hearing will be afforded an earlier opportunity to speak. Speakers may notify EOHHS of their intention to testify at the hearing by registering online at www.mass.gov\chia\regulations. Individuals may also submit written testimony by [email protected]. Please submit electronic testimony as an attached Word document or as text within the body of the email with the name of the regulation in the subject line. All submissions must include the sender's full name and address. Individuals who are unable to submit testimony by email should mail written testimony to EOHHS, c/o Corine Peach, Center for Health Information and Analysis, Two Boylston Street, Boston, MA 02116. Written testimony must be submitted by 5:00 p.m. on Friday, March 8, 2013. Copies of the proposed regulation are available for inspection and/or purchase at EOHHS or viewed at EOHHS's website at www.mass.gov\dhcfp\regulations.

Other Agencies Affected: Department of Developmental Services (DDS), Massachusetts Commission for the Blind (MCB), Massachusetts Rehabilitation Commission (MRC)

Describe the Scope and Objectives of the Regulation: Regulation 101.4 CMR 20.00 is a new regulation which governs the payment rates for Adult Long-Term Residential Services (ALTR) purchased by a governmental unit including but not limited to DDS, MCB or MRC.

Yes No Is the regulation likely to deter the formation of sma)) businesses in Massachusetts? D [gI

Yes No Is the regulation likely to encourage the formation of small businesses jn Massachusetts? D [gI

Yes No Can the regulation provide for less stringent compliance or reporting requirements for sma)) businesses? D [gI

Yes No Can the regulation establish less stringent schedules or deadlines for compliance or reporting requirements for small businesses? D [gI

Yes No Can the compliance or reporting requirements be consolidated or simplified for small businesses? D [gI

Yes No Can performance standards for sma)) businesses replace design or operational standards? D [gI

Yes No Are there alternative regulatory methods that would minimize the adverse impact on sma)) businesses? D [gI

Yes No Were any sma)) businesses or sma)) business organizations contacted during the preparation of this document? If so, please describe. D [gI

Under the provisions of M.G.L. c. 30A and pursuant to the authority found at M.G.L. c. 130 § 17A, 21 and 80 the Division of Marine Fisheries (DMF) and the Marine Fisheries Advisory Commission have scheduled a public hearing and public comment period to accept comment on regulations to amend 322 CMR 3.00,6.00, 7.00, 8.00 and 12.00. The proposed regulations will:

1. Lobster Management (322 CMR 6.01, 6.02 and 12.00) a. Permanently codify the recently enacted emergency regulations that increased the minimum carapace size for lobsters taken from Lobster Management Area 3 from 3 12 inch to 3 17/32 inch; and b. Beginning in 2014, to reduce the risk of right whale entanglements in lobster gear: i. Implement a mandatory February 1 - April 30 closure to all lobster gear set in the state waters portion of the Cape Cod Bay Right Whale Critical Habitat Area; and ll. Shift the two-month Outer Cape Cod Lobster Management Area haul-out period from January 15 - March 15 to February 1 - March 31 to better correspond with the local presence of right whales.

2. Commercial Scup and Black Sea Bass Management (322 CMR 6.27 and 6.28) a. Amend commercial black sea bass seasons, daily limits and open fishing days. i. Postpone the opening of the commercial fishery until later in the year. Options for proposed opening dates include July 1, August 1, or September I; II. Contingent up the adoption of the above proposal: 1. Eliminate the 100 lbs. black sea bass bycatch limit during January- April; 2. Increase the commercial trip limits to 500 lbs. per day for licensed sea bass pot fishermen and 200 lbs. for other authorized gear types (hook and line, trawl and weir); and 3. Establish Sunday through Thursday as open fishing days during the open commercial fishing season. b. Amend commercial scup seasons, daily limits and open fishing days - i. For Hook and Line and Pot Gears Only: 1. During May 1 - May 31, increase the trip limit for fishermen using hook and line or fish pots from 400 to 800 lbs. and allow commercial fishing five days per week (Sunday through Thursdays); 2. During June I - June 30 allow commercial fishermen using hook and line or fish pots to land 400 lbs. and allow commercial fishing three days per week (Sunday, Tuesday and Wednesday); and 11. For All Gears: 1. Amend scup seasonal trip limits during July - October for all gears (hook and line, pots, and otter trawls) from 800 to 1500 lbs.

3. Commercial Horseshoe Crab Management (322 CMR 6.34) a. Expand the May-June lunar-based spawning closures into April to address early season spawning related to warming water temperatures; and b. Eliminate the quota monitoring closure language that allowed DMF to close the fishery on July 7 to tally monthly catch data for quota management purposes. Weekly dealer reporting negated the need for this regulation.

4. Eliminate outdated recreational regulations (322 CMR 3.00,7.05,8.07 and 8.11) a. Eliminate restrictions on the numbers of hooks anglers may use to catch shad on the Palmer River and white perch on the Agawam river; b. Eliminate regulations pertaining to coho salmon; and c. Adjust various section references to conform to changes to 322 CMR 3.00.

5. Minimum Size For Surf Clams Harvested in Federal Waters (322 CMR 6.08) a. When warranted, exempt on an annual basis, federal surf clam vessels fishing in federal waters and their dealers from the state's minimum size standard, so as to conform to federal regulations.

6. Charter Boats and Posting Rules (322 CMR 7.10) a. Exempt permitted for-hire charter boats from the requirement to post minimum sizes and possession limits aboard the vessel.

7. Gillnet Pingers (322 CMR 12.04) a. Eliminate state regulations requiring gillnet fishermen to use pingers to deter harbor porpoise entanglements. Note: All vessels using gillnets in state-waters will still be subject to federal gillnet pinger regulations.

Wednesday February 13,2013 at the Massachusetts Maritime Academy Admiral's Hall, 101 Academy Drive, Buzzards Bay, Massachusetts 02532. From 5:30 PM - 9:30 PM.

Public comments will be accepted until 5PM on Friday, February 15,2013. Please e-mail all public comments to jared.silva0)state.ma.us or send to 251 Causeway Street, Suite 400, Boston, MA 02114.

For further information or to obtain a copy of the full proposed regulations please contact Jared Silva by phone (617-626-1534) or through e-mail (jared.silva0Jstate.ma.us). or visit our website (www.mass.gov/mari nefisheries).

Describe the Scope and Objectives of the Regulation: The purpose of the regulation is to constrain catch by limiting the number of hooks to one while fishing for shad in the Palmer River between the Shad Dam and the Providence Street Bridge between April 15 and July 15. After analysis of this regulatory provision in the context of small business impacts, DMF has determined that the elimination of this regulatory provision will not adversely impact the resource, may improve recreational fishing and provide a diminutive benefit to bait and tackle shops.

Business Industry(ies) Affected by the Regulation: The businesses affected by this regulation are generally considered sporting goods stores, specifically those that sell bait and tackle.

Types of Businesses Included in the Industry(ies): Bait and tackle shops are the applicable types of businesses in this industry.

Total Number of Small Businesses Included in the Regulated Industry(ies) Please see the attached guidance documents for assistance determining the total number of small businesses: The SBA dynamic small business search tool identifies 13 sporting good stores (NAISC code 451110) that qualify as small businesses in Massachusetts. DMF permits bait dealers and provides information to tackle shops, through these action the agency has determined there are 130 bait and tackle shops that qualify as small businesses within 15 miles of the coast.

Number of Small Businesses Potentially Subject to the Proposed Regulation: DMF has identified 4 bait shops in the Rehoboth area that are affected by these regulations.

Yes No Will small businesses have to create, file, or issue additional reports?

Yes No Will small businesses have to implement additional recordkeeping procedures? 0 X 322 CMR 3.0 I places gear restrictions on a discrete group of recreational fishermen, it does not 0 affect the paperwork load required of bait and tackle shops. If this rule was eliminated, these shops would not implement additional record keeping procedures.

Yes No Will small businesses have to provide additional administrative oversight? 0 Ox 322 CMR 3.01 places gear restrictions on a discrete group of recreational fishermen, it does not affect the paperwork load required of bait and tackle shops. If this rule was eliminated bait and tackle shops would not have to provide additional oversight.

Yes No Will small businesses have to hire additional employees in order to comply with the 0 Ox proposed regulation? 322 CMR 3.0 I places gear restrictions on a discrete group of recreational fishermen, it does not affect the paperwork load required of bait and tackle shops. If this rule was eliminated bait and tackle shops would not have to hire additional employees in order to ensure compliance.

Yes No Does compliance with the regulation require small businesses to hire other professionals 0 Ox (e.g. a lawyer, accountant, engineer, etc.)? 322 CMR 3.01 places gear restrictions on a discrete group of recreational fishermen, it does not affect the paperwork load required of bait and tackle shops. If this rule was eliminated bait and tackle shops would not have to hire additional professionals in order to ensure compliance.

Yes No Does the regulation require small businesses to purchase a product or make any other 0 Ox capital investments in order to comply with the regulation? 322 CMR 3.01 does not require bait and tackle shops make a capital investment to comply with this regulation. However, the sales at local bait and tackle shops may be diminished because the regulation restricts the number of hooks a recreational fisherman may use while fishing for shad on the Palmer River between the shad dam and the Providence Street Bridge.

Yes No Are performance standards more appropriate than design standards? 0 Ox Not applicable.

Yes No Does the regulation require small businesses to cooperate with audits, inspections, or other 0 Ox regulatory enforcement activities? 322 CMR 3.01 does not hold bait and tackle shops subject to regulatory enforcement activity. However, pursuant to MGL c. 130 § 9, recreational anglers fishing for shad on the Palmer River between the shad dam and the Providence bridge are subject to inspections to ensure they are fishing lines with no more than one hook. Eliminating 322 CMR 3.0 I will not affect enforcement activity at bait and tackle shops, but it reduces the scope of enforcement activity on private recreational anglers fishing for shad in a certain area of the Palmer River.

Yes No Will the regulation have the effect of creating additional taxes and/or fees for small 0 Ox businesses? 322 CMR 3.01 does not implement taxes or fees. If this rule was eliminated bait and tackle shops would not be subject to new or additional taxes and/or fees.

Yes No Does the regulation require small businesses to provide educational services to keep up to 0 Ox

Yes No Is the regulation likely to deter the formation ofsmall businesses in Massachusetts? 0 Ox At present this regulation does not deter the formation of small business in MA. However, by eliminating this regulation, recreational fishermen will not be subject to this gear restriction.

Yes No Is the regulation likely to encourage the formation of small businesses in Massachusetts? 0 Ox At present this regulation does not encourage the formation of small business in MA. The elimination of this regulation will not have a profound enough affect on bait and tackle shops to encourage the formation of new shops. However, those shops already in existence may see a boost in hook and line sales because recreational fishermen will no longer be subj ect to this gear restriction.

Yes No Can the regulation provide for less stringent compliance or reporting requirements for 0 Ox small businesses? 322 CMR 3.01 does not subject bait and tackle shops to compliance or reporting requirements.

Yes No Can the regulation establish less stringent schedules or deadlines for compliance or 0 Ox reporting requirements for small businesses? 322 CMR 3.01 does not establish compliance or reporting schedules for bait and tackle shops. If this rule was eliminated bait and tackle shops not have to meet any new or additional compliance or reporting schedules or deadlines.

Yes No Can the compliance or reporting requirements be consolidated or simplified for small 0 Ox businesses? 322 CMR 3.0 I does not require bait and tackle shops comply with certain regulations or reporting requirements. However, 322 CMR 3.01 requires recreational fishermen comply with onerous gear restrictions when fishing for shad in the Palmer River between the shad dam and the Providence Bridge.

Yes No Can performance standards for small businesses replace design or operational standards? 0 Ox Not applicable.

Yes No Are there alternat ive regulatory methods that would minimize the adverse impact on 0 Ox small businesses? By eliminating 322 CMR 3.01, recreational fishermen fishing for shad on the Palmer River between the shad dam and the Providence Bridge may choose to fish lines with multiple hooks.

Yes No Were any small businesses or small business organizations contacted during the 0 Ox preparation of this document?If so, please descri be. No.

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Describe the Scope and Objectives of the Regulation: The purpose of the regulation is to constrain the catch of white perch by limiting the number of hooks to two that white perch may be taken with from the Agawam River in Wareham between route 28 and the high tension lines.

After analysis of this regulatory provision in the context of small business impacts, DMF has determined that the elimination of this regulatory provision will not adversely impact the resource, may improve recreational fishing and may provide a diminutive increase in the sale of hook and line gear by bait and tackle shops.

Total Number of Small Businesses Included in the Regulated Industry(ies) Please see the attached guidance documents for assistance determining the total number of small businesses: The SBA dynamic small business search tool identifies 13 sporting good stores (NAISC code 451110) that qualify as small businesses in Massachusetts. DMF permits bait dealers and provides information to tackle shops, through these actions the agency has determined there are 130 bait and tackle shops that qualify as small businesses within 15 miles of the coast.

Number of Small Businesses Potentially Subject to the Proposed Regulation: DMF has identified 6 bait shops in the Wareham area that are affected by these regulations.

Yes No Will small businesses have to create, file, or issue additional reports? 0 Ox 322 CMR 3.02 places gear restrictions on a discrete group of recreational fishermen, it does not affect the paperwork load required of bait and tackle shops. If this rule was eliminated, these

Yes No Will small businesses have to implement additional record keeping procedures? 0 Ox 322 CMR 3.02 places gear restrictions on recreational anglers and has no effect on bait and tackle shops. Therefore, this rule does not prompt additional record keeping by bait and tackle shops. Ifthis rule was elimi nated, these shops would not have to implement new or additional record keeping procedures.

Yes No Will small businesses have to provide additional administrative oversight? 0 Ox 322 CMR 3.02 places gear restrictions on recreational anglers and does not effect bait and tackle shops. Therefore, this rule does not prompt additional administrative oversight at bait and tackle shops. If this rule were eliminated, these shops would not have to provide additional administrative oversight.

Yes No Will small businesses have to hire additional employees in order to comply with the 0 Ox proposed regula tion? 322 CMR 3.02 places gear restrictions on recreational anglers and does not effect bait and tackle shops. Therefore, this rule does not prompt bait and tackle shops to hire additional employees for the purpose of ensuring compliance. If this rule was eliminated, these shops would not have to hire additional employees for the purpose of compliance.

Yes No Does compliance with the regulation require small businesses to hire other professionals 0 Ox (e.g. a lawyer, accountant, engineer, etc.)? 322 CMR 3.02 places gear restrictions on recreational anglers and does not effect bait and tackle shops. Therefore, this rule does not prompt bait and tackle shops to hire professionals for the purpose of ensuring compliance. If this rule was eliminated, these shops would not have to hire professionals for the purpose of compliance.

Yes No Does the regulation require small businesses to purchase a product or make any other 0 Ox capital investments in order to comply with the regulation? 322 CMR 3.02 places gear restrictions on recreational anglers and does not effect bait and tackle shops. If this rule was eliminated, these shops would not have to produce capital investments for the purpose of compliance.

Yes No Are performance standards more appropriate than design standards? 0 Ox Not applicable.

Yes No Does the regulation require small businesses to cooperate with audits, inspections, or other 0 Ox regulatory enforcement activities? 322 CMR 3.02 does not hold bait and tackle shops subject to regulatory enforcement activity. However, pursuant to MGL c. 130 § 9, recreational anglers fishing this area of the Agawam River for white perch are bridge are subject to inspections to ensure they are fishing lines with no more than two hooks per line.

Yes No Will the regulation have the effect of creating additional taxes and/or fees for small 0 Ox businesses? 322 CMR 3.02 does not implement taxes or fees. If this rule was eliminated, these shops would not be subject to new taxes or fees.

Yes No Does the regulation require small businesses to provide educational services to keep up to 0 Ox date with regulatory requirements?

Yes No Is the regulation likely to deter the formation of small businesses in Massachusetts? 0 Ox At present this regulation does not deter the formation of small business in MA.

Yes No Is the regulation likely to encourage the formation of small businesses in Massachusetts? 0 Ox At present this regulation does not encourage the formation of small business in MA.

Yes No Can the regulation provide for less stringent compliance or reporting requirements for 0 Ox small businesses? 322 CMR 3.02 does not implement compliance or reporting requirements for bait and tackle shops.

Yes No Can the regulation establish less stringent schedules or deadlines for compliance or 0 Ox reporting requirements for small businesses? 322 CMR 3.02 does not implement compliance or reporting schedules for bait and tackle shops. If this rule was eliminated bait and tackle shops not have to meet any new or additional compliance or reporting schedules or deadlines.

Yes No Can the compliance or reporting requirements be consolidated or simplified for small 0 Ox businesses? 322 CMR 3.02 does not implement compliance or reporting schedules for bait and tackle shops.

Yes No Can performance standards for small businesses replace design or operational standards? 0 Ox Not applicable.

Yes No Are there alternat ive regulatory methods that would minimize the adverse impact on 0 Ox small businesses? The current regulation imposes a gear restriction on recreational fishermen fishing for white perch in the Agawam River.

Yes No Were any small businesses or small business organizations contacted during the 0 Ox preparation of this document?1f so, please descri be. No bait and tackle shops were contacted.

Describe the Scope and Objectives of the Regulation: In the late 1970's DMF began a program to introduce coho salmon to the waters of Massachusetts with the hopes they would spawn and populate the area. 322 CMR 3.06 was developed to regulate the catch ofthese fish. However, by the late 1980's coho salmon failed to populate Massachusetts waters and the program was discontinued. As state waters did not maintain a population of coho salmon a fishery does not exist. Consequently, DMF has determined that this regulation has no impact on small business in the state, but is, however, obsolete.

Number of Small Businesses Potentially Subject to the Proposed Regulation: As coho salmon populations were not established, there are no businesses impacted by this regulation.

Effective Date Used In Cost Estimate: December 2011.

Yes No Will small businesses have to create, file, or issue additional reports? 0 X This rule has been obsolete since the 1980's. No coho salmon fishery or fishery support 0 businesses exist to be affected by this regulation. No reporting is required by the regulation. Nor will its deletion from the CMR require any additional reporting.

Yes No Will small businesses have to implement additional recordkeeping procedures?

Yes No Will small businesses have to provide additional administrative oversight? 0 X This rule has been obsolete since the 1980's. No coho salmon fishery or fishery support 0 businesses exist to be affected by this regulation. Moreover, no administrative oversight is required by the regulation, nor will its deletion from the CMR require any administrative oversight.

Yes No Will small businesses have to hire additional employees in order to comply with the 0 X proposed regulation? 0 This rule has been obsolete since the 1980's. No coho salmon fishery or fishery support businesses exist to be affected by this regulation. Moreover, this regulation does not require the hiring of employees for the purpose of ensuring compliance, nor will its deletion from the CMR require any such action.

Yes No Does compliance with the regulation require small businesses to hire other professionals 0 X (e.g. a lawyer, accountant, engineer, etc.)? 0 This rule has been obsolete since the 1980's. No coho salmon fishery or fishery support businesses exist to be affected by this regulation. Moreover, this regulation does not require the hiring of employees for the purpose of ensuring compliance, nor will its deletion from the CMR require any such action.

Yes No Does the regulation require small businesses to purchase a product or make any other 0 X capital investments in order to comply with the regulation? 0 This rule has been obsolete since the 1980's. No coho salmon fishery or fishery support businesses exist to be affected by this regulation. Moreover, this regulation does not require capital investment for the purpose of ensuring compliance, nor will its deletion from the CMR require any such action.

Yes No Are performance standards more appropriate than design standards? 0 X Not applicable. 0 Yes No Does the regulation require small businesses to cooperate with audits, inspections, or other 0 X regulatory enforcement activities? 0 All fishery businesses are subject to inspections pursuant to M.G.L. 130 s. 9. However, this fishery has been obsolete for 25 years and there are no coho salmon businesses to inspect.

Yes No Will the regulation have the effect of creating additional taxes and/or fees for small 0 X businesses? 0 This rule has been obsolete since the 1980's. No coho salmon fishery or fishery support businesses exist to be affected by this regulation. Moreover, this regulation does not require fees or taxes to ensure compliance, nor will its deletion from the CMR require any such action.

Yes No Does the regulation require small businesses to provide educa tional services to keep up to 0 X date with regulatory requirements? 0 This rule has been obsolete since the 1980's. No coho salmon fishery or fishery support businesses exist to be affected by this regulation. Moreover, this regulation does not require the production of educational materials for the purpose of ensuring compliance, nor will its deletion

Yes No Is the regulation likely to deter the formation of small businesses in Massachusetts? D X The coho salmon introduction program failed to populate MA waters. Therefore, a resource D does not exist to support a business. This regulation is obsolete; striking it from the CMR will not deter the formation of small business.

Yes No Is the regulation likely to encourage the formation of small businesses in Massachusetts? D X The coho salmon introduction program failed to populate MA waters. Therefore, a resource D does not exist to support a business. This regulation is obsolete; striking it from the CMR will not encourage the formation of small business.

Yes No Can the regulation provide for less stringent compliance or reporting requirements for D X small businesses? D This rule has been obsolete since the 1980's. No coho salmon fishery or fishery support businesses exist to be affected by this regulation. The deletion of this regulation will not implement compliance or reporting requirements.

Yes No Can the regulation establish less stringent schedules or deadlines for compliance or D X reporting requirements for small businesses? D This rule has been obsolete since the 1980's. No coho salmon fishery or fishery support businesses exist to be affected by this regulation. The deletion ofthis regulation will not implement compliance or reporting schedules or deadlines.

Yes No Can the compliance or reporting requirements be consolidated or simplified for small xD D businesses? As these rules are obsolete, this section of the CMR can be deleted.

Yes No Can performance standards for small businesses replace design or operational standards? D X Not applicable. D Yes No Are there alternative regulatory methods that would minimize the adverse impact on D X small businesses? D While not minimizing impacts on small business, this regulation is obsolete and should be eliminated.

Yes No Were any small businesses or small business organizations contacted during the D X preparation of this document?If so, please descri be. D No small businesses exist to be contacted.

c: Describe the Scope and Objectives of the Regulation: Require all offshore fishermen authorized to commercial harvest lobster to discard lobsters taken from Lobster Conservation Management Area 3 (LCMA3) with a carapace smaller than 3 17/32". This action is being taken pursuant to the Atlantic States Marine Fisheries Commission's Addendum XVll to the American Lobster Interstate Fishery Management Plan.

Business Industry(ies) Affected by the Regulation: Commercial fishing businesses authorized to catch, retain and land American lobster from LCMA3.

Types of Businesses Included in the Industry(ies): Commercial lobster trap, gillnet and mobile gear vessels permitted to take lobster from LCMA 3.

Total Number of Small Businesses Included in the Regulated Industry(ies) Please see the attached guidance documents for assistance determining the total number of small businesses: After reviewing the results of the SBA dynamic small business search tool, it has been determined that this tool is inadequate at accurately identifying the number of small businesses (NAISC codes: 114111 (finfish fishermen); 114112 (shellfish fisherman) potentially affected by this regulation. DMF instead finds it appropriate to use permitting and reporting data to identify these businesses. In 2011 there were 23 permits that reported landing lobsters from traps in LCMA 3. Additionally, in 20 II there are were 247 vessels authorized to take lobsters with net gear in LCMA 3 - it is difficult to determine how many would be affected by this because many of these vessels fish across different Lobster Management Areas, which makes catch report data less reliable when determining area oflobster harvest.

Number of Small Businesses Potentially Subject to the Proposed Regulation: In 2011 there were 23 permits that reported landing lobsters from traps from LMCA 3. Additionally, in 20 II there are were 247 vessels authorized to take lobsters with net gear in LCMA 3; it is difficult to determine how many would be affected by this because many of these vessels fish across different Lobster Management Areas, which makes catch report data less reliable when determining area oflobster harvest.

*Note: For each question, please answer 'yes" or "no" and offer a brief explanation. Please describe any facts, data, views, arguments, or other inputfrom small businesses,

Yes No Will small businesses have to create, file, or issue additional reports?

0 X This proposed action will not require commercial lobster fishermen file additional reports. All commercial fishermen are subject to the reporting requirements set forth at 50 CFR or developed pursuant to M.G.L. c. 130 s. 21.

Yes No Will small businesses have to implement additional record keeping procedures?

0 X This action does not require additional recordkeeping.

Yes No Will small businesses have to provide additional administrative oversight?

0 X This action does not require additional administrative oversight.

Yes No Will small businesses have to hire additional employees in order to comply with the proposed regulation? 0 X This will have no effect on the payroll of commercial lobster business.

Yes No Does compliance with the regulation require small businesses to hire other professionals (e.g. a lawyer, accountant, engineer, etc.)? 0 X This will have no effect on the payroll of commercial lobster business.

Yes No Does the regulation require small businesses to purchase a product or make any other capital investments in order to comply with the regulation? 0 X This requires no capital investment for the purpose of compliance.

Yes No Are performance standards more appropriate than design standards?

0 X Not applicable.

Yes No Does the regulation require small businesses to cooperate with audits, inspections, or other regulatory enforcement activities? 0 X This will not produce additional audits or inspections, commercial permit holders will be subject to typical law enforcement activity authorized by M.GL c. 130.

Yes No Will the regulation have the effect of creating additional taxes and/or fees for small businesses? 0 X This regulation will not create additional taxes or fees commerciallobstermen are subject to.

Yes No Does the regulation require small businesses to provide educational services to keep up to date with regulatory requirements? 0 X This regulation does not require commercial lobster permit holders provide educational services.

Yes No Is the regulation likely to deter the formation of small businesses in Massachusetts?

Yes No Is the regulation likely to encourage the formation of small businesses in Massachusetts?

0 X Entrance into the lobster fishery is constrained by a limited entry permitting scheme.

Yes No Can the regulation provide for less stringent compliance or reporting requirements for small businesses? 0 X The Atlantic Coastal Fisheries Cooperative Management Act (ACFCMA) requires all states implement regulations that uphold and comply with the interstate fishery management plans (FMP). The lobster FMP was recently amended to require this increase to the LMA3 minimum size.

Yes No Can the regulation establish less stringent schedules or deadlines for compliance or reporting requirements for small businesses? 0 X January 1,2013

Yes No Can the compliance or reporting requirements be consolidated or simplified for small businesses? 0 X This is not applicable.

Yes No Can performance standards for small businesses replace design or operational standards?

0 X This is not applicable.

Yes No Are there alternative regulatory methods that would minimize the adverse impact on small businesses? 0 X The Atlantic Coastal Fisheries Cooperative Management Act (ACFCMA) requires all states implement regulations that uphold and comply with the interstate fishery management plans (FMP). The lobster FMP was recently amended to require this increase to the LMA3 minimum size.

Yes No Were any small businesses or small business organizations contacted during the preparation of this document?1f so, please descri be. Ox 0 Yes. Massachusetts commerciallobstermen, through their involvement on the Lobster Conservation and Management Team, helped develop this management action.

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Describe the Scope and Objectives of the Regulation: The purpose of322 CMR 6.08(3)(c) is to implement a minimum size for the commercial surf clam fishery. This regulation conserves the resource by reducing the take of juvenile surf clams, and thereby allowing for reproduction.

After an analysis of this regulatory provision, in the context of small business impacts, DMF has determined that exempting federal permitted commercial surf clams harvesters and wholesale dealers from the minimum size, which is consistent with the federal rule,w ould not result in the depletion of the resource, and would enhance economic benefits to these commercial fishermen. To ensure compliance with the current rules, federal waters harvesters must sort high volumes of surf clams at sea and discard those smaller than the 5" minimum size in order to possess and land these clams in Massachusetts. This requires a tremendous amount of time but failure to comply puts both the harvester and dealer/processor at risk for non-compliance fines for possessing sub-legal shellfish. Eliminating the minimum size requirement would create more efficient fishing by doing away with the onerous process associated with separating the different sized clams.

Business Industry(ies) Affected by the Regulation: The affected businesses include offshore commercial surf clam harvesters and wholesale dealers purchasing surf clams.

Types of Businesses Included in the Industry(ies): Offshore surf clam dredge businesses and wholesale dealers that handle shellfish.

Total Number of Small Businesses Included in the Regulated IndustryCies) Please see the attached guidance documents for assistance determining the total number ofsmall businesses: Under NAISC code 11412 (shellfish), the SBA dynamic small business search tool does not provide an accurate number of commercial surf clam vessels and dealers. As commercial fishing and procurement offish in Massachusetts is permitted and reporting is required,DM F statistics more accurately depicts the num ber of small businesses in the regulated industry. In 2011, there were 31 federal surf clam perm it holders with surf clam landings in Massachusetts and 15 wholesale dealers in Massachusetts purchasing surf clams from federally permitted harvesters.

Yes No Will small businesses have to create, me, or issue additional reports? 0 Ox No.

Yes No Will small businesses have to implement additional record keeping procedures? 0 Ox No.

Yes No Will small businesses have to provide additional administrative oversight? 0 Ox No.

Yes No Will small businesses have to hire additional employees in order to comply with the 0 Ox proposed regulation? No.

Yes No Does compliance with the regulation require small businesses to hire other professionals 0 Ox (e.g. a lawyer, accountant, engineer, etc.)? No.

Yes No Does the regulation require small businesses to purchase a product or make any other 0 Ox capital investments in order to comply with the regulation? No.

Yes No Are performance standards more appropriate than design standards? 0 Ox Not applicable.

Yes No Does the regulation require small businesses to cooperate with audits, inspections, or other 0 Ox regulatory enforcement activities? Pursuant to 50 CFR 648 and MGL c. 130 § 4A & 9, fishing vessels and wholesale dealers are subject to inspection. 322 CMR 6.08(3)(c), does not trigger additional enforcement activity. However, amending this rule to exempt federal permit holders and wholesale dealers from the surf clam minimum size will reduce the time needed to sort catch to comply with the minimum size rule and will reduce the scope of enforcement activity some of the regulated community must comply with.

Yes No Will the regulation have the effect of creating additional taxes and/or fees for small 0 Ox businesses? No.

Yes No Does the regulation require small businesses to provide educa tiona Iservices to keep up to 0 Ox date with regulatory requirements? No.

Yes No Is the regulation likely to deter the formation of small businesses in Massachusetts? 0 Ox This regulation has no net effect on the formation of small businesses in Massachusetts.

Yes No Is the regulation likely to encourage the formation of small businesses in Massachusetts? 0 Ox This regulation has no net effect on the formation of small businesses in Massachusetts. However, refining it to exempt federal permit holders and whole sale dealers from minimum size restrictions will allow current participants to operate their businesses more efficiently.

Yes No Can the regulation provide for less stringent compliance or reporting requirements for xO 0 small businesses? Yes. Exempting federal harvesters from minimum size standards will ensure they will not have to sort high volumes of surf clams to ensure compliance with the state's minimum size.

Yes No Can the regulation establish less stringent schedules or deadlines for compliance or 0 Ox reporting requirements for small businesses? There are no applicable compliance schedules or deadlines.

Yes No Can the compliance or reporting requirements be consolidated or simplified for small Ox 0 businesses? Yes. Exempting federal harvesters from minimum size standards will ensure they will not have to sort high volumes of surf clams to ensure compliance with the state's minimum size.

Yes No Can performance standards for small businesses replace design or operational standards? 0 Ox Not applicable.

Yes No Are there alternative regulatory methods that would minimize the adverse impact on Ox 0 small businesses? Yes. Exempting federal harvesters from minimum size standards will ensure they will not have to sort high volumes of surf clams to ensure compliance with the state's minimum size.

Yes No Were any small businesses or small business organizations contacted during the 0 Ox preparation ofthis document? If so, please descri be. DMF did not consult any small businesses during the preparation of this document. However, federal permit holders and wholesale dealers have recently made DMF aware that they wish to be exempt from the minimum size at 322 CMR 6.08(3)(c).

Describe the Scope and Objectives of the Regulation: 322 CMR 6.27(4)(a) requires all commercially permitted black sea bass and scup fishermen report their catch on forms supplied by the Director no later than January 31 of each year and the failure to submit an accurate report of falsifying such a report may result in the suspension or revocation of the scup or black sea bass permit.

After an analysis of this regulatory provision, in the context of small business impacts, D MF has determined that this regulation can be eliminated to reduce the burden of reporting requirements and schedules. DMF no longer requires annual catch reports, and as commercial black sea bass and scup permit endorsement holders are currently required to file monthly trip level reports, it is duplicitous and unnecessary to require they also submit annual reports. Business Industry(ies) Affected bv the Regulation: The industry sectors affected by this regulation includes commercial fishermen permitted to take scup and black sea bass.

Types of Businesses Included in the Industry(ies): Businesses within this industry sector include commercial pot and trap fishermen, commercial hook and line fishermen and commercial trawlers.

Total Number of Small Businesses Included in the Regulated Industrv(ies) Please see the attached guidance documents for assistance determining the total number ofsmall businesses: The SBA dynamic small business search tool does not provide an accurate number commercial fishing businesses permitted to take black sea bass and scup - NAISC code 114111 (finfish). As all commercial fishing in Massachusetts is permitted and all permit holders are required to file catch reports, DMF statistics can more accurately describe the number of small businesses in the regulated industry. For 20 11, there were 3,474 commercial scup and black sea bass permit holders who were required to produce monthly trip level reports and annual catch reports. However, as scup and black sea bass are commonly caught together a substantial amount of these permits are held by dual permit holders.

Number of Small Businesses Potentially Subject to the Proposed Regulation: All 3,747 scup and sea bass permit endorsement holders are required to report their catch in an annual catch report. However, only 997 were actively fished in 2011 and over the past 3 years there have been on average 937 active

Yes No Will small businesses have to create, file, or issue additional reports? xD D Pursuant to M.G.L. c. 130 s. 21, commercial fishermen shall file catch reports as required by the Director of the Division of Marine Fisheries. Beginning in 2010, DMF required all commercial fishermen file monthly trip level catch reports. Despite, 322 CMR 6.27(4)(a), DMF does not require fishermen submit annual catch reports, as monthly trip level reporting helps DMF better monitor catch rates, effort and quota. Therefore, this regulation is duplicitous and unnecessary.

Yes No Will small businesses have to implement additional record keeping procedures? D X This rule does not require additional recordkeeping procedures. However, by eliminating 322 D CMR 6.27(4)(a), commercial black sea bass and scup permit holders will not be required to maintain annual reporting records in addition to trip level reporting records.

Yes No Will small businesses have to provide additional administrative oversight? D X This rule does not require additional administrative oversight. Moreover, eliminating this rule D will not require additional administrative oversight.

Yes No Will small businesses have to hire additional employees in order to comply with the D X proposed regulation? D This rule does not require the hiring of additional employees. Moreover, eliminating this rule will not require the hiring of additional employees.

Yes No Does compliance with the regulation require small businesses to hire other professionals D X (e.g. a lawyer, accountant, engineer, etc.)? D This rule does not require the hiring of additional professionals. Moreover, eliminating this rule will not require the hiring of additional professionals.

Yes No Does the regulation require small businesses to purchase a product or make any other D X capital investments in order to comply with the regulation? D Complying with this rule does not require capital investment. Moreover, eliminating this rule will not require additional capital investment.

Yes No Are performance standards more appropriate than design standards? D X Not applicable. D Yes No Does the regulation require small businesses to cooperate with audits, inspections, or other D X regulatory enforcement activities? D This regulation does not require commercial black sea bass or scup permit holders cooperate with regulatory enforcement activities, these fishermen are required to do so pursuant to M.G.L. c. 130 § 9. Moreover, eliminating 322 CMR 6.27(4)(a) will not make these fishermen subject to additional inspections or enforcement activities.

Yes No Does the regulation require small businesses to provide educa tional services to keep up to D X date with regulatory requirements? D 322 CMR 6.27(4)(a) does not require educational services be provided, eliminating this rule will not require it either.

Yes No Is the regulation likely to deter the formation of small businesses in Massachusetts? D X 322 CMR 6.27(4)(a) does not influence the development of new businesses in MA; quota D availability, permit availability, species market value, fish abundance and operating cost are the driving factors in the development of new black sea bass and scup fishing businesses. Eliminating this rule will, however, allow current businesses to operate without redundant reporting requirements.

Yes No Is the regulation likely to encourage the formation of small businesses in Massachusetts? D X 322 CMR 6.27(4)(a) does not influence the development of new businesses in MA; quota D availability, permit availability, species market value, fish abundance and operating cost are the driving factors in the development of new black sea bass and scup fishing businesses. Eliminating this rule will, however, allow current businesses to operate without redundant reporting requirements.

Yes No Can the regulation provide for less stringent compliance or reporting requirements for xD D small businesses? By eliminating 322 CMR 6.27( 4)(a), black sea bass and scup commercial permit holders will not be required by law to submit redundant catch reports.

Yes No Can the regulation establish less stringent schedules or deadlines for compliance or xD D reporting requirements for small businesses? By eliminating 322 CMR 6.27(4)(a), black sea bass and scup commercial permit holders will not be required by law to submit an annual catch report in addition to monthly trip level reports.

Yes No Can the compliance or reporting requirements be consolidated or simplified for small xD D businesses? By eliminating 322 CMR 6.27(4)(a), black sea bass and scup commercial permit holders will not be required by law to submit redundant catch reports and therefore these permit holders will be subject to only monthly reporting deadlines.

Yes No Can performance standards for small businesses replace design or operational standards? D X Not applicable. D Yes No Are there alternat ive regulatory methods that would minimize the adverse impact on xD D small businesses? By eliminating 322 CMR 6.27(4)(a), black sea bass and scup commercial permit holders will not be required by law to submit redundant catch reports.

Yes No Were any small businesses or small business organizations contacted during the D X preparation of this document?If so, please descri be. D No.

Describe the Scope and Objectives of the Regulation: Manages the state's commercial scup and black sea bass quota managed fisheries through seasons, fishing days, trip limits and minimum sizes.

Types of Businesses Included in the Industry(ies): Commercial finfish fishermen with permit endorsements to possess and land black sea bass and scup and seafood dealers that purchase black sea bass and scup.

Total Number of Small Businesses Included in the Regulated Industry(ies) Please see the attached guidance documents for assistance determining the total number of small businesses: After reviewing the SBA number for 114111 "Finfish Fishing," the DMF does not believe the directory adequately describes the total number of permitted businesses in the Commonwealth of Massachusetts. Pursuant to MGL c. 130 s. 80, the Division of Marine Fisheries issues permits to all commercial fishing operations in the Commonwealth. In 2011, the Division of Marine Fisheries issued 3,474 commercial scup and black sea bass endorsements, however, each endorsement is not a unique permit holder as many fishermen hold both a scup and black sea bass endorsements and some individuals even hold more than one specific species en dorsements.

After reviewing the SBA number for 424460 "Fish and Seafood Merchants," DMF does not believe the directory adequately describes the total number of permitted businesses in the Commonwealth of Massachusetts. Pursuant to M.G.L. c. 130 s. 80, the Division of Marine Fisheries issues permits to all Massachusetts commercial seafood dealers. In 20 II, the Division of Marine Fisheries issued 1,710 seafood dealer permits.

Number of Small Businesses Potentially Subject to the Proposed Regulation: While all 3,474 permit holders may be subject to this regulation, only 997 scup and black sea bass endorsements reported landings in 2011. This is typical, as over the past 3 years there has been an average of937 active permit holders.

Similarly, the 1,710 seafood dealers may all be potentially affected by these regulations; however, only 454 of them were authorized as primary buyers in 2011 and allowed to purchase fish directly from fishermen.

Yes No Will small businesses have to create, file, or issue additional reports? The proposed amendments to 322 CMR 6.28 will not require the creation or filling of additional reports. 0 [gJ

Yes No Will small businesses have to implement additional record keeping procedures? The proposed amendments to 322 CMR 6.28 will not require additional recordkeeping. 0 [gJ

Yes No Will small businesses have to provide additional administrative oversight? The proposed amendments to 322 CMR 6.28 will not require additional administrative oversight to ensure [gJ 0 compliance.

Yes No Will small businesses have to hire additional employees in order to comply with the proposed regulation? The proposed amendments to 322 CMR 6.28 will not require the hiring [gJ 0 of additional employees to ensure compliance.

Yes No Does compliance with the regulation require small businesses to hire other professionals (e.g. a lawyer, accountant, engineer, etc.)? The proposed amendments to 322 CMR 6.28 will [gJ 0 not require the hiring of additional professionals to ensure compliance.

Yes No Does the regulation require small businesses to purchase a product or make any other capital investments in order to comply with the regulation? No capital investment is [gJ 0 required to comply with the proposed regulations.

Yes No Are performance standards more appropriate than design standards? Not applicable. 0 [gJ

Yes No Does the regulation require small businesses to cooperate with audits, inspections, or other regulatory enforcement activities? Fishing operations are already subject to audits and [gJ 0 inspections by the Environmental Police to ensure compliance with fishery regulations. The proposed regulation does not require additional cooperation with audits or inspections.

Yes No Will the regulation have the effect of creating additional taxes and/or fees for small businesses? The proposed amendments to 322 CMR 6.28 will not require the paying of [gJ 0 additional taxes or fees for the purpose of compliance.

Yes No Does the regulation require small businesses to provide educational services to keep up to date with regulatory requirements? The proposed amendments to 322 CMR 6.28 will not [gJ 0 require education services for the purpose of compliance.

Yes No Is the regulation likely to deter the formation ofsmall businesses in Massachusetts? Entrance into the black sea bass fishery is constrained by a limited entry permitting scheme. [gJ 0 Price, value and permit availability are the greatest constraining factors on the formation of business in Massachusetts. Therefore, this action is unlikely to deter the formation of business

Scup is an open access fishery. While overhead costs and market value ofscup will likely limit the formation of small businesses, the increased trip limits m ay provide greater incentive for presently permitted commercial fishermen to pursue the scup fishery.

Seafood dealers will be affected by the availability of the fish for the market but this availability of fish will not likely influence the formation of new seafood dealer businesses.

Yes No Is the regulation likely to encourage the formation of small businesses in Massachusetts? Entrance into the black sea bass fishery is constrained by a limited entry permitting scheme. 0 ~ Price, value and permit availability constrain the formation of new fishing businesses in Massachusetts.

Overhead costs, market value and the availabil ity of other species endorsements will constrain the formation of new commercial scup businesses. However, the increased trip limits may provide greater incentive for presently permitted commercial fishermen to pursue the scup fishery.

Seafood dealers will be affected by the availability of the fish for the market but this availability offish will not likely influence the formation of new seafood dealer businesses.

Yes No Can the regulation provide for less stringent compliance or reporting requirements for small businesses? This regulation does not affect compliance or reporting requirements. 0 ~ Compliance is determined by the environmental police through inspection pursuant to M.G.L. c. 130 s. 9,10, 12 and 13. Commercial fishermen are required to report their commercial landings on a monthly trip level basis pursuant to M.G.L. c. 130 s. 21.

Yes No Can the regulation establish less stringent schedules or deadlines for compliance or reporting requirements for small businesses? This regulation does not affect compliance or 0 ~ reporting schedules. Compliance is determined by the environmental police through inspection pursuant to M.G.L. c. 130 s. 9, 10,12 and 13. Commercial fishermen are required to report their commercial landings on a monthly trip level basis pursuant to M.G.L. c. 130 s. 2l.

Yes No Can the compliance or reporting requirements be consolidated or sim plified for small businesses? This regulation does not affect compliance or reporting. Compliance is 0 ~ determined by the environmental police through inspection pursuant to M.G.L. c. 130 s. 9, 10, 12 and 13. Commercial fishermen are required to report their commercial landings on a monthly trip level basis pursuant to M.G.L. c. 130 s. 21.

Yes No Can performance standards for small businesses replace design or operational standards? Not applicable. 0 ~

Yes No Are there alternat ive regulatory methods that would minimize the adverse impact on small businesses? Not applicable. 0 ~

Yes No Were any small businesses or small business organizations contacted during the preparation of this document?If so, please describe. No. 0 ~

Describe the Scope and Objectives of the Regulation: This regulation proposes to eliminate the horseshoe crab quota monitoring closure at 322 CMR 6.34(4), as weekly dealer reporting has rendered this closure obsolete. At 322 CMR 6.34(7), DMF is also proposing to implement spawning closures to protect and conserve local horseshoe crab populations.

Business Industry(ies) Affected by the Regulation: Commercial horseshoe crab fishermen, LAL bio-medical extraction companies and commercial bait dealers.

Types of Businesses Included in the Industry(ies): Commercial fishermen, commercial bait dealers and LAL biomedical extraction companies.

Total Number of Small Businesses Included in the Regulated Industry(ies) Please see the attached guidance documents for assistance determining the total number of small businesses: Under NAISC code 11412 (shellfish), the SBA dynamic small business search tool does not provide an accurate number commercial permit holders harvesting horseshoe crabs. As all commercial fishing in Massachusetts is permitted and all permit holders must file catch reports, DMF statistics more accurately depicts the number of small businesses in the regulated industry. In 2011 there were 55 commercial permit holders harvesting horseshoe crabs.

After reviewing the SBA number for 424460 "Fish and Seafood Merchants," DMF does not believe the directory adequately describes the total number of permitted businesses in the Commonwealth of Massachusetts. Pursuant to M.G.L. c. 130 s. 80, the Division of Marine Fisheries issues permits to all Massachusetts commercial bait dealers. In 2011, the Division of Marine Fisheries issued 159 bait dealer permits of which 15 purchased horseshoe crabs directly from fishermen.

After reviewing the SBA number for 541711, Biotechnology, DMF does not believe the directory adequately describes the total number of businesses extract LAL from horseshoe crabs in Massachusetts. Through prior experience there is only one business in the Commonwealth obtaining horseshoe crabs for this purpose.

Number of Small Businesses Potentially Subject to the Proposed Regulation: There are 55 commercial permit holders harvesting horseshoe crabs in MA, 15 bait dealers and 1 biomedical business that may be potentially affected by proposed draft regulation.

Yes No Will small businesses have to create, file, or issue additional reports? The proposed amendments to 322 CMR 6.34 will not require the creation or filling of additional reports. D [gJ

Yes No Will small businesses have to implement additional recordkeeping procedures? The proposed amendments to 322 CMR 6.34 will not require additional recordkeeping. D [gJ

Yes No Will small businesses have to provide additional administrative oversight? The proposed amendments to 322 CMR 6.34 will not require additional administrative oversight to ensure [gJ D compliance.

Yes No Will small businesses have to hire additional employees in order to comply with the proposed regulation? The proposed amendments to 322 CMR 6.34 will not require the hiring [gJ D of additional employees to ensure compliance.

Yes No Does compliance with the regulation require small businesses to hire other professionals (e.g. a lawyer, accountant, engineer, etc.)? The proposed amendments to 322 CMR 6.34 will [gJ D not require the hiring of additional professionals to ensure compliance.

Yes No Does the regulation require small businesses to purchase a product or make any other capital investments in order to comply with the regulation? No capital investment is [gJ D required to comply with the proposed regulations.

Yes No Are performance standards more appropriate than design standards? Not applicable. D [gJ

Yes No Does the regulation require small businesses to cooperate with audits, inspections, or other regulatory enforcement activities? Fishing operations are already subject to audits and [gJ D inspections by the Environmental Police to ensure compliance with fishery regulations. The proposed regulation does not require additional cooperation with audits or inspections.

Yes No Will the regulation have the effect of creating additional taxes and/or fees for small businesses? The proposed amendments to 322 CMR 6.6.34 will not require the paying of [gJ D additional taxes or fees for the purpose of compliance.

Yes No Does the regulation require small businesses to provide educational services to keep up to date with regulatory requirements? The proposed amendments to 322 CMR 6. 6.34 will not [gJ D require education services for the purpose of compliance.

Yes No Is the regulation likely to encourage the formation of small businesses in Massachusetts? Entry into the commercial horseshoe crab harvest is limited. Therefore, this regulation will 0 I:8J have no affect on the formation of small businesses in Massachusetts. Horseshoe crabs provide a small portion of the general bait market and this regulation should not affect the formation of bait businesses. Only one business has actively pursued extracting LAL from horseshoe crab blood prior to this regulation, management of this fishery does not likely limit the formation of new bio-tech businesses.

Yes No Can the regulation provide for less stringent compliance or reporting requirements for small businesses? This regulation does not affect compliance or reporting requirements. 0 I:8J Compliance is determined by the environmental police through inspection pursuant to M.G.L. c. 130 s. 9, 10, 12 and 13. Commercial fishermen are required to report their commercial landings on a monthly trip level basis pursuant to M.G.L. c. 130 s. 21 and commercial dealers acting as primary buyers are required to report their purchases.

Yes No Can the regulation establish less stringent sched ules or deadlines for compliance or reporting requirements for small businesses? This regulation does not affect current 0 I:8J compliance or reporting schedules for any of the affected businesses.

Yes No Can the compliance or reporting requirements be consolidated or sim plified for small businesses? This regulation does not affect compliance or reporting requirements for any ofthe 0 I:8J affected businesses.

Yes No Can performance standards for small businesses replace design or operational standards? Not applicable. 0 I:8J

Yes No Are there alternative regulatory methods that would minimize the adverse impact on small businesses? Not applicable. 0 I:8J

Yes No Were any small businesses or small business organizations contacted during th e preparation of this document?1f so, please describe. No. 0 I:8J

Describe the Scope and Objectives of the Regulation: 322 CMR 7.1 0(5)(b) requires all for-hire recreati onal fishing operations notify all persons fishing on board their vessel ofthe applicable fishing rules. To that end, all charter and head boat operators in Massachusetts must conspicuously post written rules detailing minimum sizes and bag limits of all target species and give verbal notice to all persons fishing on board their vessels ofthe minimum sizes and bag limits for all target species.

After analysis ofthis regulatory provision for the purpose of small business impacts, DMF has determined it is onerous to require charter boat captains post these fishery rules or face non-compliance fines. Many of the state's charter vessels are 20-30' center counsole vessels with limited space to post such notices. As such, DMF finds it appropriate to exempt charter vessels from 322 CMR 7.1 0(5)(b)(i).

Business Industry(ies) Affected by the Regulation: Recreational for-hire fishing vessels.

Types of Businesses Included in the Industry(ies): Recreational charter fishing vessels.

Total Number of Small Businesses Included in the Regulated Industry(ies) Please see the attached guidance documents for assistance determining the total number ofsmall businesses: The SBA dynamic small business search tool does not provide an accurate number for hire fishermen (NAISC code 114111 (finfish). All for-hire fishing businesses in Massachusetts are small businesses and are permitted through DMF. As such, DMF's permit holder data more accurately depicts the number of regulated vessels. In 2011, there were 930 permitted for-hire fishing businesses in Massachusetts.

Number of Small Businesses Potentially Subject to the Proposed Regulation: All 930 for-hire fishing businesses are subject to the regulations at 322 CMR 7.1 0(5)(b). IfDMF was to exempt charter boats from said regulation, it would be exempting 871 of those vessels.

Effective Date Used In Cost Estimate: December 2011.

Yes No Will small businesses have to create, file, or issue additional reports?

D X For-hire vessels are not required to create, file or issue reports under 322 CMR 7.IO(5)(b). The D national Marine Recreational Fishing Statistical Survey may contact to survey operators or survey the patron's catch to help determine recreational harvest data. Exempting charter vessels from the requirements of322 CMR 7.1 O(5)(b)(i) will not require reporting.

Yes No Will small businesses have to implement additional record keeping procedures?

D X For-hire vessels are not required to implement recordkeeping procedures under 322 CMR D 7. I O(5)(b). The national Marine Recreational Fishing Statistical Survey may contact operators or survey for catch to help determine recreational harvest data. Exempting charter vessels from the requirements of322 CMR 7.IO(5)(b)(i) will not require recordkeeping.

Yes No Will small businesses have to provide additional administrative oversight?

D X For-hire vessels are not required to provide additional administrative oversight under 322 CMR D 7.IO(5)(b). Exempting charter vessels from the requirements of322 CMR 7.1O(5)(b)(i) will not require additional administrative requirements.

Yes No Will small businesses have to hire additional employees in order to comply with the proposed regulation? D X D For-hire vessels are not required to hire additional employees to comply with 322 CMR 7.1O(5)(b). Exempting charter vessels from the requirements of322 CMR 7.1 O(5)(b )(i) will not require additional employees for the purpose of ensuring compliance.

Yes No Does compliance with the regulation require small businesses to hire other professionals (e.g. a lawyer, accountant, engineer, etc.)? D X D For-hire vessels are not required to hire additional professionals to comply with 322 CMR 7.IO(5)(b). Exempting charter vessels from the requirements of 322 CMR 7.1 O(5)(b)(i) will not require additional professionals for the purpose of ensuring compliance.

Yes No Does the regulation require small businesses to purchase a product or make any other capital investments in order to comply with the regulation? xD D 322 CMR 7.1 O(5)(b) requires for-hire vessels invest in a document that depicts target fish species and provides the minimum size and bag limits for these species. By exempting charter vessels from this regulation, this majority component of the for-hire fleet will not have invest in the production of this document.

Yes No Are performance standards more appropriate than design standards?

D X Not applicable. D

Yes No Does the regulation require small businesses to cooperate with audits, inspections, or other

Pursuant to M.G.L. c. 130 s. 13 anyone engaged in fishing activity must display fish upon demand. 322 CMR 7.1O(5)(b) has no authority over regulatory law enforcement activity. If charter boats are exempt from 322 CMR 7. I 0(5)(b)(i), they will not be forced to comply with an onerous regulatory requirement to post fishing rules.

Yes No Will the regulation have the effect of creating additional taxes and/or fees for small businesses? 0 X 0 No, 322 CMR 7.1 0(5)(b) does not subject for-hire vessels to additional taxes or fees. Exempting charter vessels from the requirements of 322 CMR 7.1 0(5)(b)(i) will not require additional taxes or fees.

Yes No Does the regulation require small businesses to provide educa tional services to keep up to date with regulatory requirements? xO 0 322 CMR 7.1 0(5)(b) does require for-hire vessel operators educate their customers on the sizes and bag lim its of target fish species. This provision does not require a large investment in educational materials or services, beyond posting and verbally announcing the pertinent information. If charter vessels were exempt from 322 CMR 7.1 0(5)(b )(i) they would not have produce and post a document that shows pertinent fishing rules.

Yes No Is the regulation likely to deter the formation of small businesses in Massachusetts?

0 X The establishment of for-hire fishing businesses is reliant on fish availability and abundance, 0 tourism and the knowledge ofthe operator. 322 CMR 7.10 does not have an effect on these aspects of the business,an d therefore, should not deter the formation of small businesses. However, if charter boat operators were exempt from 322 CMR 7.1 0 current and future small businesses will not be subject to onerous requirements.

Yes No Is the regulation likely to encourage the formation of small businesses in Massachusetts?

0 X The establishment of for-hire fishing businesses is reliant on fish availability and abundance, 0 tourism and the knowledge of the operator. 322 CMR 7.1 0 does not have an effect on these aspects of the business and therefore, should not encourage the formation of for-hire businesses. However, if charter boat operators were exempt from 322 CMR 7.1 0 current and future small businesses will not be subject to onerous requirements.

Yes No Can the regulation provide for less stringent compliance or reporting requirements for small businesses? xO 0 Yes, by exempting charter vessels from 322 CMR 7.1 0(5)(b)(i) these vessels will not be subject to stringent and onerous regulations that require they conspicuously post rules on their vessel, when their vessel may not have the space to accommodate such a posting.

Yes No Can the regulation establish less stringent schedules or deadlines for compliance or reporting requirements for small businesses? 0 X 0 322 CMR 7.1 0(5)(b) does not govern deadlines or schedules for compliance and reporting.

Yes No Can performance standards for small businesses replace design or operational standards?

0 X Not applicable. 0

Yes No Are there alternative regulatory methods that would minimize the adverse impact on small businesses? xD 0 Yes, by exempting charter vessels from 322 CMR 7.1 O(5)(b )(i) these vessels will not be subject to stringent and onerous regulations that require they conspicuously post rules on their vessel, when their vessel may not have the space to accommodate such a posting.

Yes No Were any small businesses or small business organizations contacted during the preparation of this document?1f so, please descri be. xD 0 When implementing the recreational fishing permit last winter, DMF received comment from charter vessels requesting an exemption from 322 CMR 7.1 O(5)(b )(i). However, due to administrative burdens, DMF was not able to accommodate a rule change at that time.

Describe the Scope and Objectives of the Regulation: Improve the organization of322 CMR 12.00. Implement a February I - April 30 gear haul out for the Right Whale Critical Habitat Area in Eastern Cape Cod Bay. Adjust the Outer Cape Cod gear haul out period from January 15 - March 15 to February I - March 31.

Number of Small Businesses Potentially Subject to the Proposed Regulation: There are about 100 affected commercial lobster fishermen. There are about 10,000 recreational lobster permit holders who may be affected, however, most do not set gear during the winter season.

Yes No Will small businesses have to create, file, or issue additional reports?

0 ~ No additional reporting will be required.

Yes No Will small businesses have to implement additional record keeping procedures?

0 ~ No additional record keeping will be required.

Yes No Will small businesses have to provide additional administrative oversight?

Yes No Will small businesses have to hire additional employees in order to comply with the proposed regulation? 0 ~ Affected commerciallobstermen will not have to hire additional employees to comply with this regulation.

Yes No Does compliance with the regulation require small businesses to hire other professionals (e.g. a lawyer, accountant, engineer, etc.)? 0 ~ Affected commerciallobstermen will not have to hire professional employees to comply with this regulation.

Yes No Does the regulation require small businesses to purchase a product or make any other capital investments in order to comply with the regulation? 0 ~ No capital investment is required to comply.

Yes No Are performance standards more appropriate than design standards?

0 ~ Not applicable.

Yes No Does the regulation require small businesses to cooperate with audits, inspections, or other regulatory enforcement activities? 0 ~ No audits or inspections are required.

Yes No Will the regulation have the effect of creating additional taxes and/or fees for small businesses? 0 ~ No additional taxes or fees will be levied.

Yes No Does the regulation require small businesses to provide educational services to keep up to date with regulatory requirements? 0 ~ Education services are not required.

Yes No Is the regulation likely to deter the formation of small businesses in Massachusetts?

0 ~ The commercial lobster industry in Massachusetts is constrained by a limited entry permitting scheme. This regulation does not affect the number of available lobster permits and therefore will not deter the formation of new businesses.

Yes No Is the regulation likely to encourage the formation of small businesses in Massach usetts?

Yes No Can the regulation provide for less stringent compliance or reporting requireme nts for small businesses? 0 ~ At present, this regulation is less stringent and does not require a gear haul out in Cape Cod

Yes No Can the regulation establish less stringent schedules or deadlines for compliance or reporting requirements for small businesses? 0 C8J Schedules and deadlines for compliance are not required. DMF will lift these gear haul out periods when right whale aggregations disperse the affected areas.

Yes No Can the compliance or reporting requirements be consolidated or simplified for small businesses? 0 C8J No.

Yes No Can performance standards for small businesses replace design or opera tional standards?

0 C8J Not applicable.

Yes No Are there alternative regulatory methods that would minimize the adverse impact on small businesses? 0 C8J No, this proposed action will has a minimal impact on small businesses, as only 2% ofthe overall annual landings from affected area are taken during this time period.

Yes No Were any small businesses or small business organizations contacted during the preparation of this document?1f so, please descri be. C8J 0 DMF has been working with commercial lobstermen from the affected area in developing this regulation.

!j) ::.~... -~~r--'

Describe the Scope and Objectives ofthe Regulation: Consistent with the federal Harbor Porpoise Take Reduction Plan (HPTRP) and the Marine Mammal Protection Act, these regulations aim to minimize harbor porpoises entanglements with sink gillnet fishing gear. These measures include a March closure to sink gillnet fishing gear to a discrete area in Massachusetts Bay and a discrete area south of and west of Cape Cod. It also requires sink gillnet fishermen use pingers in discrete areas 0 f Massachusetts Bay and southern New England when harbor porpoise are commonly found.

Pursuant to the Marine Mammal Protection Act, the rules of the federal harbor porpoise take reduction plan extend from shore through the Economic Exclusive Zone (200 mi) and are therefore applicable in state waters. In May 2010, the HPTRP was updated and the closure and pinger areas increased in size, including in areas of state waters. However, the Division of Marine Fisheries was not authorized to adjust the state regulations accordingly. As such, state rules are more liberal than federal rules, and these discrepancies may confuse state waters gill net fishermen. This may lead sink gillnet fishermen to believe they are authorized to set sink gillnet gear in closed areas or set sink gillnet gear without pingers in pinger areas. Federal fines for non-compliance with the HPTRP range from $2,000 - $100,000. After an analysis of this regulatory provision in the context of small business impacts, DMF has determined that 322 CMR 12.04(2)(b) & (c) and 12.04(3), expose state waters gillnet fishermen to confusing and non-conforming regulations that may result in severe non-compliance penalties and should be eliminated.

Business Industry(ies) Affected by the Regulation: Businesses affected by the regulation include state-waters sink gillnet fishermen.

Types of Businesses Included in the Industry(ies): Types of businesses included in the industry are fishing businesses that use sink gillnet gear in state waters.

Total Number of Small Businesses Included in the Regulated Industry(ies) Please see the attached guidance documents for assistance determining the total number of small businesses: The SBA dynamic small business search tool does not provide an accurate number of state waters gillnet fishermen - NAISC code 114111 (finfish fishermen). All commercial fishing in Massachusetts is permitted and all permit holders must file catch reports. As such, DMF statistics more accurately depicts the number of small businesses in the regulated industry. For 2011, there were 33 state waters sink gillnet permit holders, as each gillnet fishing operation employs less than 500 people, there were 33 small businesses in the regulated industry.

Yes No Will small businesses have to create, file, or issue additional reports? D xD Commercial permit holders must file catch reports pursuant to 50 CFR 648 (federal) and MGL c. 130 § 21 (state). 322 CMR 12.04(b)&(c) and 12.04(3) does not require permitted state sink gillnet permit holders file additional reports. Therefore, amending 322 CMR l2.04(b)&(c) and 12.04(3) to eliminate confusion between state and federal rules will not require additional reporting.

Yes No Will small businesses have to implement additional record keeping procedures? D X 322 CMR 12.04(b )&(c) and 12.04(3) does not require permitted state waters sink gillnet fishing D businesses keep records. Therefore, amending 322 CMR l2.04(b)&(c) and 12.04(3) to eliminate confusion between state and federal rules will not require additional administrative requirements.

Yes No Will small businesses have to provide additional administrative oversight? D X 322 CMR 12.04(b )&(c) and 12.04(3) does require administrative oversight of state waters sink D gillnet fishing businesses. Therefore, amending 322 CMR 12.04(b )&( c) and 12.04(3) to eliminate confusion between state and federal rules will not require additional administrative oversights.

Yes No Will small businesses have to hire additional employees in order to comply with the D X proposed regulation? D The sink gillnet closure and sink gillnet pigner requirements at 322 CMR 12.04(b )&( c) and 12.04(3) does not require the hiring of employees to comply with current regulations. Therefore, amending 322 CMR 12.04(b)&(c) and 12.04(3) to eliminate confusion between state and federal rules will not require sink gillnet vessels hire additional employees to ensure compliance.

Yes No Does compliance with the regulation require small businesses to hire other professionals D X (e.g. a lawyer, accountant, engineer, etc.)? D The sink gillnet closure and sink gillnet pigner requirements at 322 CMR 12.04(b)&(c) and 12.04(3) does not require the hiring of professional staff to comply with current regulations. Therefore, amending 322 CMR 12.04(b)&(c) and 12.04(3) to eliminate confusion between state and federal rules will not require sink gillnet vessels hire additional professional staff to ensure compliance.

Yes No Does the regulation require small businesses to purchase a product or make any other D D capital investments in order to comply with the regulation? X The Federal Harbor Porpoise Take Reduction plan requires all sink gillnet fishermen fishing in state and federal waters attach pingers to the sink gillnet strings in certain discrete areas during

Yes No Are performance standards more appropriate than design standards? 0 X Not applicable. 0 Yes No Does the regulation require small businesses to cooperate with audits, inspections, or other 0 X regulatory enforcement activities? 0 Pursuant to 50 CFR and MGL c. 130 § 9, fishing vessels and their gear are subject to inspection. 322 CMR 12.04(b )&( c) and 12.04(3) does not trigger additional enforcement activity. However, eliminating this rule will reduce confusion pertaining to the current discrepancies between state and federal rules, which could eliminate accidental non-compliance incidents subject to large federal non-compliance fines.

Yes No Will the regulation have the effect of creating additional taxes and/or fees for small 0 X businesses? 0 322 CMR 12.04(b)&(c) and 12.04(3) does not create additional taxes or fees. Refining this provision to eliminate conflicting federal and state rules will not require any additional taxes or fees.

Yes No Does the regulation require small businesses to provide educational services to keep up to 0 X date with regulatory requirements? 0 322 CMR 12.04(b )&(c) and 12.04(3) does not require educational services. Elim inating this provision will not require any educational services be provided.

Yes No Is the regulation likely to deter the formation of small businesses in Massachusetts? 0 X This regulation has no effect on the formation of small businesses in Massachusetts, as the sink 0 gillnet fishery is managed under a limited entry permitting scheme. However, the current conflicting state and federal regulations may result in large non-compliance fines levied against Massachusetts' sink gillnet vessels.

Yes No Is the regulation likely to encourage the formation of small businesses in Massachusetts? 0 X This regulation has no effect on the formation of small businesses in Massachusetts, as the sink 0 gillnet fishery is managed under a limited entry permitting scheme. However, the current conflicting state and federal regulations may result in large non-compliance fines levied against Massachusetts' sink gillnet vessels. Elim inating the conflicting state rules will reduce the chances of accidental non-compliance and the subsequent issuance of federal penalties.

Yes No Can the regulation provide for less stringent compliance or reporting requirements for xD 0 small businesses? As the rules at 322 CMR 12.04(b )&(c) and 12.04(3) conflict with the federal plan, regulated state-waters businesses may be vulnerable to non-compliance. Eliminating this provision will reduce regulatory confusion and reduce the risk that large federal non-compliance fines are levied against these businesses.

Yes No Can the regulation establish less stringent schedules or deadlines for compliance or 0 X reporting requirements for small businesses? 0 322 CMR 12.04(b)&(c) and 12.04(3) does not establish schedules or deadlines for compliance or reporting. Refining this provision to eliminate conflicting federal and state rules will not

Yes No Can the compliance or reporting requirements be consolidated or simplified for small xD 0 businesses? Eliminating 322 CMR 12.04(b)&(c) and 12.04(3), which conflicts with the federal plan, will simplify compliance requirements for state sink gillnet fishermen and will consequently reduce the chances of accidental non-compliance and the subsequent issuance of federal penalties.

Yes No Can performance standards for small businesses replace design or operational standards? 0 X Not applicable. 0 Yes No Are there alternat ive regulatory methods that would minimize the adverse impact on 0 X small businesses? 0 The federal plan must be adopted by all vessels using sink gillnets.

Yes No Were any small businesses or small business organizations contacted during the xD 0 preparation of this document?1f so, please descri be. At past public hearings and meetings, sink gillnet operators have requested DMF either eliminate 322 CMR 12.04(b)&(c) and 12.04(3) to reduce regulatory confusion or revise it so that it is consistent with the federal rule.

Describe the Scope and Objectives of the Regulation: This regulation establishes the Coastal Access Permit for fishermen using mobile gear in state-waters.

Business Industry(ies) Affected by the Regulation: Commercial fishing businesses that use mobile gear in state waters.

Types of Businesses Included in the Industry(ies): Commercial fishermen permitted to use trawl and dredge gear.

Total Number of Small Businesses Included in the Regulated Tndustry(ies) Please see the attached guidance documents for assistance determining the total number of small businesses: After reviewing the SBA number for 114111 "Finfish Fishing," and 114112 "Shellfish Fishing" DMF does not believe that these numbers adequate quantify the number of participants issued commercial fishing permits to use mobile gear in state waters. Pursuant to MGL c. 130 s. 80, the Division of Marine Fisheries issues permits to all commercial fishing operations in the Commonwealth. DMF issued 210 Coastal Access Permits in 2011.

Number of Small Businesses Potentially Subject to the Proposed Regulation: No business are affected by this proposed regulation. This action is a technical correction that changes the reference at 322 CMR 7.05 to 322 CMR 3.04. This action is necessary, as the section 322 CMR 3.00 is being revised.

Yes No Will small businesses have to create, file, or issue additional reports? D X No. This is a technical correction to a reference to 322 CMR 3.04 at 322 CMR 7.05 - a result of D proposed revisions to 322 CMR 3.00.

Yes No Will small businesses have to implement additional record keeping procedures?

Yes No Will small businesses have to provide additional administrative oversight? 0 Ox No. This is a technical correction to a reference to 322 CMR 3.04 at 322 CMR 7.05 - a result of proposed revisions to 322 CMR 3.00.

Yes No Will small businesses have to hire additional employees in order to comply with the 0 Ox proposed regulation? No. This is a technical correction to a reference to 322 CMR 3.04 at 322 CMR 7.05 - a result of proposed revisions to 322 CMR 3.00.

Yes No Does compliance with the regulation require small businesses to hire other professionals 0 Ox (e.g. a lawyer, accountant, engineer, etc.)? No. This is a technical correction to a reference to 322 CMR 3.04 at 322 CMR 7.05 - a result of proposed revisions to 322 CMR 3.00.

Yes No Does the regulation require small businesses to purchase a product or make any other 0 Ox capital investments in order to comply with the regulation? No. This is a technical correction to a reference to 322 CMR 3.04 at 322 CMR 7.05 - a result of proposed revisions to 322 CMR 3.00.

Yes No Are performance standards more appropriate than design standards? 0 Ox No. This is a technical correction to a reference to 322 CMR 3.04 at 322 CMR 7.05 - a result of proposed revisions to 322 CMR 3.00.

Yes No Does the regulation require small businesses to cooperate with audits, inspections, or other 0 Ox regulatory enforcement activities? No. This is a technical correction to a reference to 322 CMR 3.04 at 322 CMR 7.05 - a result of proposed revisions to 322 CMR 3.00.

Yes No Will the regulation have the effect of creating additional taxes and/or fees for small 0 Ox businesses? No. This is a technical correction to a reference to 322 CMR 3.04 at 322 CMR 7.05 - a result of proposed revisions to 322 CMR 3.00.

Yes No Does the regulation require small businesses to provide educational services to keep up to 0 Ox date with regulatory requirements? No. This is a technical correction to a reference to 322 CMR 3.04 at 322 CMR 7.05 - a result of proposed revisions to 322 CMR 3.00.

Yes No Is the regulation likely to deter the formation of small businesses in Massachusetts? 0 Ox No. This is a technical correction to a reference to 322 CMR 3.04 at 322 CMR 7.05 - a result of proposed revisions to 322 CMR 3.00.

Yes No Is the regulation likely to encourage the formation of small businesses in Massachusetts? 0 Ox No. This is a technical correction to a reference to 322 CMR 3.04 at 322 CMR 7.05 - a result of proposed revisions to 322 CMR 3.00.

Yes No Can the regulation provide for less stringent compliance or reporting requirements for 0 Ox small businesses? No. This is a technical correction to a reference to 322 CMR 3.04 at 322 CMR 7.05 - a result of

Yes No Can the regulation establish less stringent schedules or deadlines for compliance or 0 Ox reporting requirements for small businesses? No. This is a technical correction to a reference to 322 CMR 3.04 at 322 CMR 7.05 - a result of proposed revisions to 322 CMR 3.00.

Yes No Can the compliance or reporting requirements be consolidated or simplified for small 0 Ox businesses? No. This is a technical correction to a reference to 322 CMR 3.04 at 322 CMR 7.05 - a result of proposed revisions to 322 CMR 3.00.

Yes No Can performance standards for small businesses replace design or operational standards? 0 Ox No. This is a technical correction to a reference to 322 CMR 3.04 at 322 CMR 7.05 - a result of proposed revisions to 322 CMR 3.00.

Yes No Are there alternative regulatory methods that would minimize the adverse impact on 0 Ox small businesses? t I I _.- -- - - . .•••••••••••• _'II E"Y"O _ n~ 1.•. _.s:- ,

Describe the Scope and Objectives of the Regulation: This section establishes regulations to protect and conserve the state's coastal fisheries.

Business Industry(ies) Affected by the Regulation: All commercial fmfish fishermen.

Types of Businesses Included in the Industry(ies): All commercial net and hook and line fishermen.

Total Number of Small Businesses Included in the Regulated Industry(ies) Please see the attached guidance documents for assistance determining the total number of small businesses: After reviewing the SBA number for 114111 "Finfish Fishing," the DMF does not believe the directory adequately describes the total number of permitted businesses in the Commonwealth of Massachusetts. Pursuant to MGL c. 130 s. 80, the Division of Marine Fisheries issues permits to all commercial fishing operations in the Commonwealth. In 2011, DMF issued more than 4,000 commercial fisherman permits.

Number of Small Businesses Potentially Subject to the Proposed Regulation: No business are affected by this proposed regulation. This action is a technical correction that changes the reference at 322 CMR 8.07 and 8.11 to 322 CMR 3.00. This action is necessary, as the section 322 CMR 3.00 is being revised.

Yes No Will small businesses have to create, file, or issue additional reports? D X No. This is a technical correction to a reference to 322 CMR 3.04 at 322 CMR 8.07 and 8.11 - D a result of proposed revisions to 322 CMR 3.00.

Yes No Will small businesses have to provide additional administrative oversight? 0 Ox No. This is a technical correction to a reference to 322 CMR 3.04 at 322 CMR 8.07 and 8.11 - a result of proposed revisions to 322 CMR 3.00.

Yes No Will small businesses have to hire additional employees in order to comply with the 0 Ox proposed regulation? No. This is a technical correction to a reference to 322 CMR 3.04 at 322 CMR 8.07 and 8.11 - a result of proposed revisions to 322 CMR 3.00.

Yes No Does compliance with the regulation require small businesses to hire other professionals 0 Ox (e.g. a lawyer, accountant, engineer, etc.)? No. This is a technical correction to a reference to 322 CMR 3.04 at 322 CMR 8.07 and 8.11 - a result of proposed revisions to 322 CMR 3.00.

Yes No Does the regulation require small businesses to purchase a product or make any other 0 Ox capital investments in order to comply with the regulation? No. This is a technical correction to a reference to 322 CMR 3.04 at 322 CMR 8.07 and 8.11 - a result of proposed revisions to 322 CMR 3.00.

Yes No Are performance standards more appropriate than design standards? 0 Ox No. This is a technical correction to a reference to 322 CMR 3.04 at 322 CMR 8.07 and 8.11 - a result of proposed revisions to 322 CMR 3.00.

Yes No Does the regulation require small businesses to cooperate with audits, inspections, or other 0 Ox regulatory enforcement activities? No. This is a technical correction to a reference to 322 CMR 3.04 at 322 CMR 8.07 and 8.11 - a result of proposed revisions to 322 CMR 3.00.

Yes No Will the regulation have the effect of creating additional taxes and/or fees for small 0 Ox businesses? No. This is a technical correction to a reference to 322 CMR 3.04 at 322 CMR 8.07 and 8.11 - a result of proposed revisions to 322 CMR 3.00.

Yes No Does the regulation require small businesses to provide educational services to keep up to 0 Ox date with regulatory requirements? No. This is a technical correction to a reference to 322 CMR 3.04 at 322 CMR 8.07 and 8.11 - a result of proposed revisions to 322 CMR 3.00.

Yes No Is the regulation likely to deter the formation of small businesses in Massachusetts? 0 Ox No. This is a technical correction to a reference to 322 CMR 3.04 at 322 CMR 8.07 and 8.11 - a result of proposed revisions to 322 CMR 3.00.

Yes No Is the regulation likely to encourage the formation of small businesses in Massachusetts? 0 Ox No. This is a technical correction to a reference to 322 CMR 3.04 at 322 CMR 8.07 and 8.11 - a result of proposed revisions to 322 CMR 3.00.

Yes No Can the regulation provide for less stringent compliance or reporting requirements for 0 Ox small businesses?

Yes No Can the regulation establish less stringent schedules or deadlines for compliance or 0 Ox reporting requirements for small businesses? No. This is a technical correction to a reference to 322 CMR 3.04 at 322 CMR 8.07 and 8.11 - a result of proposed revisions to 322 CMR 3.00.

Yes No Can the compliance or reporting requirements be consolidated or simplified for small 0 Ox businesses? No. This is a technical correction to a reference to 322 CMR 3.04 at 322 CMR 8.07 and 8.11 - a result of proposed revisions to 322 CMR 3.00.

Yes No Can performance standards for small businesses replace design or operational standards? 0 Ox No. This is a technical correction to a reference to 322 CMR 3.04 at 322 CMR 8.07 and 8.11 - a result of proposed revisions to 322 CMR 3.00.

Yes No Are there alternative regulatory methods that would minimize the adverse impact on 0 Ox small businesses? No. This is a technical correction to a reference to 322 CMR 3.04 at 322 CMR 8.07 and 8.11 - a result of proposed revisions to 322 CMR 3.00.

Yes No Were any small businesses or small business organizations contacted during the 0 Ox preparation of this document? If so, please describe. No. This is a technical correction to a reference to 322 CMR 3.04 at 322 CMR 8.07 and 8.11 - a result of proposed revisions to 322 CMR 3.00.

OEVAL L. PATRICK GOVERNOR Office of the General Counsel TIMOTHY P. MURRAY LIEUTENANT GOVERNOR Second Floor JUOYANN BIGBY, MO SECRETARY Telephone (617) 624-5230 LAUREN A. SMITH, MO, MPH INTERIM COMMISSIONER Fax (617) 624-5234

Notice is hereby given pursuant to M.G.L. c. 30A, §2, that the Department of Public Health will hold public hearings on an emergency regulation 105 CMR 216.000: Massachusetts Wellness Tax Credit Incentive.

The Massachusetts Legislature enacted a tax credit to incentivize smaller businesses to offer wellness programs in 2013 - 2017. The regulation establishes criteria that will make businesses with 500 or fewer employees, and especially those with 100 or fewer employees, eligible for a tax credit towards costs of implementing a DPH-certified program.

Hearings will be held on Monday, February 11,2013 at 11:00 a.m. in the Public Health Council Room, Second Floor, Department of Public Health, 250 Washington Street, Boston, Massachusetts and Thursday, February 14,2013 at 1 PM at DPH Western Regional Health Office, 23 Service Center, Northampton, MA 01060.

Speakers are requested to provide a copy of their oral testimony. The Department encourages all interested parties to submit testimony electronically to the following address: [email protected]. Please submit electronic testimony as an attached Word document or as text within the body of an email and type "wellness tax credit incentive" in the subject line. All submissions must include the sender's full name and address. The Department will post all electronic testimony that complies with these instructions on its website. Parties who are unable to submit electronic testimony should mail submissions to LouAnn Stanton, Office of the General Counsel, Department of Public Health, 250 Washington Street, Boston, MA 02108. All testimony must be submitted by 5:00 p.m. on Friday, February 15,2013

A copy of the emergency regulation may be viewed on the Department's website or obtained from LouAnn Stanton, Office of the General Counsel, at 617-624-5220.

7.2 :2H!d 9 I ;l\fr £ IOl ~G!S!' .- i J ' ('

Statutory Authority: St. 2012 c.224 , sections 41, 56, 60, 297 M.G.L. c. 62 § 6N and M.G.L. c. 63 § 38FF, and M.G.L. c. 111, §§2G, 206, 206A.

Describe the Scope and Objectives of the Regulation: Chapter 224 Wellness Tax Credit provides a state tax credit of25% ofthe costs related to implementing an employee wellness program by a Massachusetts small business, up to $10,000 in a given year. It is designed to improve the health of individual employees by creating a supportive environment in the worksite, offering awareness and education programs that disseminate health information that address the specific needs and health risks of employees, and supporting employees seeking to improve their health through lifestyle change.

Business Industry(ies) Affected by the Regulation: Small employers with less than 500 employees may voluntarily implement employee wellness programs and if the program receives seal of approval, the employer may apply for a state tax credit of25% of the costs incurred.

Types of Businesses Included in the Industry(ies): all types of industries can apply for the Wellness Tax Credit Incentive

Number of Small Businesses Potentially Subject to the Proposed Regulation: none are mandated, participation is voluntary

r8J D 1. Employers seeking the tax credit must complete forms required by the Department to determine their eligibility for the Wellness Program Tax Credit. In addition to contact information, the form requests information on items such as:

a. Whether the employer offers employees health benefits

b. The employee participation rate

c. Where employees reside

d. Minimum program requirements

3. The employer will also need to provide certain information to the Department of Revenue to claim the Wellness Tax Credit.

Yes No Will small businesses have to implement additional record keeping procedures?

r8J D Those voluntarily participating will have to maintain documentation of their eligibility as well as of eligible expenses.

Yes No Will small businesses have to provide additional administrative oversight?

D r8J voluntary

Yes No Will small businesses have to hire additional employees in order to comply with the proposed regulation? D r8J voluntary, though employers may wish to hire contactors or vendors to implement the program

Yes No Does compliance with the regulation require small businesses to hire other professionals (e.g. a lawyer, accountant, engineer, etc.)? D r8J voluntary, though employers may wish to hire contactors or vendors to implement the program

Yes No Does the regulation require small businesses to purchase a product or make any other capital investments in order to comply with the regulation? D r8J voluntary

Yes No Are performance standards more appropriate than design standards?

r8J D If the small business chooses to participate and receive a 25% tax credit, it is expected that the business will meet minimum eligibility requirements including employee participation.

Yes No Does the regulation require small businesses to cooperate with audits, inspections, or other regulatory enforcement activities? D r8J They are expected to apply for certification and attest that the answers are correct and true.

Yes No Will the regulation have the effect of creating additional taxes and/or fees for small

This is a Wellness Tax Credit Incentive program

Yes No Does the regulation require small businesses to provide educational services to keep up to date with regulatory requirements? 0 I:8J

Yes No Is the regulation likely to deter the formation of small businesses in Massachusetts?

0 I:8J No, this is a voluntary incentive program.

Yes No Is the regulation likely to encourage the formation of small businesses in Massachusetts? 0 I:8J

Yes No Can the regulation provide for less stringent compliance or reporting requirements for small businesses? 0 I:8J I (;~ l'U Lan lIlt: rt;~Ula"'IUu t:~ •.aUl1~1l Ie.,., 3t.IIUe"'Ut. .,,,u,,,uu..,,,., va _"',..._•••• "'0,7 JI.""' __ v •...,..,.u....__ ...... reporting requirements for small businesses? 0 I:8J This is voluntary and is created for only small businesses

Yes No Can the compliance or reporting requirements be consolidated or simplified for small businesses? 0 I:8J This is voluntary and is created for only small businesses

Yes No Can performance standards for small businesses replace design or operational standards?

0 I:8J This is voluntary and is created for only small businesses

Yes No Are there alternative regulatory methods that would minimize the adverse impact on small businesses? 0 I:8J This is voluntary and is created for only small businesses and has no adverse impact on small businesses

Yes No Were any small businesses or small business organizations contacted during the preparation of this document? If so, please describe. I:8J 0 Representatives of small businesses are invited to participate in a listening session on November 28,2012.

DEVAL L. PATRICK GOVERNOR TIMOTHY P. MURRAY LIEUTENANT GOVERNOR

JUDYANN BIGBY, MD SECRETARY LAUREN A. SMITH, MD, MPH INTERIM COMMISSIONER

NOTICE OF PUBLIC HEARING

Notice is hereby given pursuant to M.G.L. c. 30A, §2, that the Department of Public Health will hold a public hearing on proposed rescission of 105 CMR 651.000: Program for Air Testing Testing and Remedial Measures for Residential Dwellings Insulated with Urea Formaldehyde Foam Insulation (UFFI).

The Department of Public Health proposes to rescind 105 CMR 651.000. Since the statutes authorizing this regulation have been repealed and the air testing and remedial program has been completed, this regulation is now obsolete. The hearing will be held on Wednesday, February 13, 2013 at 2:00 p.m. in the Public Health Council Room, Second Floor, Department of Public Health, 250 Washington Street, Boston, Massachusetts. Speakers are requested to provide a copy of their oral testimony. The Department encourages all interested parties to submit testimony electronically to the following address: [email protected] Please submit electronic testimony as an attached Word document or as text within the body of an email and type “UFFI” in the subject line. All submissions must include the sender’s full name and address. The Department will post all electronic testimony that complies with these instructions on its website. Parties who are unable to submit electronic testimony should mail submissions to LouAnn Stanton, Office of the General Counsel, Department of Public Health, 250 Washington Street, Boston, MA 02108. All testimony must be submitted by 5:00 p.m. on Friday, February 15, 2013.

A copy of the proposed amendments may be viewed on the Department’s website or obtained from LouAnn Stanton, Office of the General Counsel, at 617-624-5220.

Regulation No: 105 CMR 651.000: Program for Air Testing and Remedial Measures for Residential Dwellings Insulated with Urea Formaldehyde Foam Insulation (UFFI)

Statutory Authority: M.G.L. c. 111, § 5; c. 112, § 87AAAY2; c. 167, § 47; c. 225, § 121; St. 1985, c. 728, § 14

Describe the Scope and Objectives of the Regulation: MDPH intends to rescind this regulation. The program established by the regulation was successfully completed many years ago, and all specific enabling statutes have been repealed.

Yes No *Note: For each question, please answer 'yes" or "no" and offer a brief explanation. Please describe any facts, data, views, arguments, or other input from small businesses, or/(anizations or any other sources that were used to quantify the impacts outlined below. Yes No Will small businesses have to create, file, or issue additional reports? 0 ~ Yes No Will small businesses have to implement additional recordkeeping procedures? 0 ~ Yes No Will small businesses have to provide additional administrative oversight? 0 ~ Yes No Will small businesses have to hire additional employees in order to comply with the 0 ~ proposed regulation?

Yes No Does compliance with the regulation require small businesses to hire other professionals 0 ~ (e.g. a lawyer, accountant, engineer, etc.)?

Yes No Does the regulation require small businesses to purchase a product or make any other 0 ~ capital investments in order to comply with the regulation?

Yes No Will the regulation have the effect of creating additional taxes and/or fees for small D ~ businesses?

Yes No Does the regulation require small businesses to provide educational services to keep up to D ~ date with regulatory requirements?

Yes No Is the regulation likely to deter the formation of small businesses in Massachusetts? D ~ Yes No Is the regulation likely to encourage the formation of small businesses in Massachusetts? D ~ Yes No Can the regulation provide for less stringent compliance or reporting requirements for D ~ small businesses?

Yes No Can the regulation establish less stringent schedules or deadlines for compliance or D ~ reporting requirements for small businesses?

Yes No Can the compliance or reporting requirements be consolidated or simplified for small D ~ businesses?

Yes No Can performance standards for small businesses replace design or operational standards? D ~ Yes No Are there alternative regulatory methods that would minimize the adverse impact on D ~ small businesses?

Yes No Were any small businesses or small business organizations contacted during the D ~ preparation of this document? If so, please describe.

2013 CUMULATIVE TABLE TO THE MASSACHUSETTS REGISTER 1225 - 1227

The cumulative Table lists all regulations and amendments thereto published in the Massachusetts Register during the current year. The Table is published in each Register.

State agencies are listed in the Table as they appear in the Code of Massachusetts Regulations (CMR or Code) in CMR numerical order which is based on the cabinet structure. For example, all Human Service agencies are prefaced by the number “1" and are designated as 101 CMR through 130 CMR.

The Cumulative Tables published in the last issue of previous years will have a listing of all regulations published for that year. These Registers are: April 6, 1976 - 1977 Register: # 88 Date: 1995 Register: #871 1978 138 1996 Supp. # 2 807 1979 193 1997 833 1980 241 1998 859 1981 292 1999 885 1982 344 2000 911 1983 396 2001 937 1984 448 2002 963 1985 500 2003 989 1986 546 2004 1016 1987 572 2005 1042 1988 598 2006 1068 1989 624 2007 1094 1990 650 2008 1120 1991 676 2009 1146 1992 702 2010 1172 1993 729 2011 1198 1994 755 2012 1124

Effective Issue Date

101 CMR Executive Office for Health and Human Services 310.00 Adult Day Health Services ...... 1227 2/1/13

113 The text of the regulations published in the electronic version of the Massachusetts Register is unofficial and for informational purposes only. The official version is the printed copy which is available from the State Bookstore at http://www.sec.state.ma.us/spr/sprcat/catidx.htm. Effective Issue Date

105 CMR Department of Public Health 700.000 Implementation of M.G.L. c. 94C ...... 1227 2/1/13 701.000 Regulations Adopted Jointly by the Department of Public Health and the Board of Registration in Pharmacy for the Implementation of M.G.L. c. 94C ...... 1227 2/1/13 721.000 Standards for Prescription Format and Security in Massachusetts - Emergency ...... 1225 12/18/12 ...... 1227 2/1/13

130 CMR Division of Medical Assistance 420.000 Dental Services - Emergency ...... 1226 1/1/13 433.000 Physician Services - Correction ...... 1225 9/28/12

202 CMR Division of Standards 7.00 Price Disclosure - Emergency ...... 1226 1/1/13

220 CMR Department of Public Utilities 18.00 Net Metering ...... 1227 2/1/13

247 CMR Board of Registration in Pharmacy 2.00 Definitions - Compliance (MA Reg. # 1222) ...... 1227 11/1/12 6.00 Registration, Management and Operation of a Pharmacy or Pharmacy Department ...... 1227 2/1/13 10.00 Disciplinary Proceedings ...... 1227 2/1/13

264 CMR Board of Registration of Real Estate Appraisers 1.00 Disciplinary Proceedings ...... 1227 2/1/13 5.00 Licensure/Certification Requirements ...... 1227 2/1/13 8.00 Reciprocity for State-Licensed/State Certified Real Estate Appraisers 1227 2/1/13

322 CMR Division of Marine Fisheries 6.00 Regulation of Catches - Emergency ...... 1226 12/31/12

515 CMR Department of State Police 1.00 Collection, Submission, Receipt, Identification, Storage, and Disposal of DNA Samples - Emergency ...... 1225 12/12/12 2.00 Testing and Analysis, Quality Assurance, Computerized Storage, Retrieval, and Dissemination for the State DNA Database - Emergency ...... 1225 12/12/12

540 CMR Registry of Motor Vehicles 2.00 Motor Vehicle Regulations ...... 1226 1/18/13

114 The text of the regulations published in the electronic version of the Massachusetts Register is unofficial and for informational purposes only. The official version is the printed copy which is available from the State Bookstore at http://www.sec.state.ma.us/spr/sprcat/catidx.htm. Effective Issue Date

603 CMR Department of Elementary and Secondary Education 7.00 Educator Licensure ...... 1225 1/4/13

606 CMR Department of Early Education and Care 10.00 Subsidized Child Care ...... 1226 1/18/13 - Correction (MA Reg. # 1226) ...... 1227 1/18/13

651 CMR Executive Office of Elder Affairs 4.00 The State Funded Nutrition Program for Elderly Persons ...... 1225 1/4/13

956 CMR Commonwealth Health Insurance Connector Authority 7.00 Small Group Wellness Incentive Program ...... 1227 2/1/13

115 The text of the regulations published in the electronic version of the Massachusetts Register is unofficial and for informational purposes only. The official version is the printed copy which is available from the State Bookstore at http://www.sec.state.ma.us/spr/sprcat/catidx.htm.

THE COMMONWEALTH OF MASSACHUSETTS William Francis Galvin Secretary of the Commonwealth

Regulation Filing To be completed by filing agency

CHAPTER NUMBER: 101 CMR 310.00

CHAPTER TITLE: Adult Day Health Services

AGENCY: Executive Office for Health and Human Services

SUMMARY OF REGULATION: State the general requirements and purposes of this regulation. The amendments establish rate increases for adult day health services. In addition, language was added to authorize the issuance of regulatory provisions via administrative bulletins, to clarify the filing and reporting requirements, and to update penalty language. To maintain the annual impact of the rate increases, add-on rates have been computed for each service, applicable to services provided between 10/1/12 and 06/30/13.

REGULATORY AUTHORITY: M.G.L. c. 118E and c. 12C

AGENCY CONTACT: Deborah M. Briggs PHONE: 617-847-3302

ADDRESS: 100 Hancock Street, Quincy, MA 02171

Compliance with M.G.L. c. 30A

EMERGENCY ADOPTION - if this regulation is adopted as an emergency, state the nature of the emergency.

PRIOR NOTIFICATION AND/OR APPROVAL - If prior notification to and/or approval of the Governor, Legislature or others was required, list each notification, and/or approval and date, including notice to the Local Government Advisory Commission. Executive Order 485: 07/16/12 Executive Office of Communities and Development: 08/31/12 Massachusetts Municipal Association: 08/31/12

PUBLIC REVIEW - M.G.L. c. 30A sections 2 and/or 3 requires notice of the hearing or comment period, including a small business impact statement, be filed with the Secretary of the Commonwealth, published in appropriate newspapers, and sent to persons to whom specific notice must be given at least 21 days prior to such hearing or comment period.

Date of public hearing or comment period: 10/12/12

For the first five years:

No fiscal effect:

SMALL BUSINESS IMPACT - M.G.L. c. 30A section 5 requires each agency to file an amended small business impact statement with the Secretary of the Commonwealth prior to the adoption of a proposed regulation. If the purpose of this regulation is to set rates for the state, this section does not apply.

Date amended small business impact statement was filed: n/a

CODE OF MASSACHUSETTS REGULATIONS INDEX - List key subjects that are relevant to this regulation:

ATTESTATION - The regulation described herein and attached hereto is a true copy of the regulation adopted by this agency. ATTEST:

SIGNATURE: SIGNATURE ON FILE DATE: Jan 18 2013

Publication - To be completed by the Regulations Division

MASSACHUSETTS REGISTER NUMBER: 1227 DATE: 02/01/2013

EFFECTIVE DATE: 02/01/2013

CODE OF MASSACHUSETTS REGULATIONS Remove these pages: Insert these pages: 1, 2 1, 2 ---- 81, 82 ---- 601 - 604

01/18/2013 kr

Table of Contents Page

(101 CMR 1.00 THROUGH 9.00: RESERVED) 5

101 CMR 10.00: TRANSITIONAL PLANNING SERVICES 45

Section 10.01: Purpose 45 Section 10.02: Definitions 45 Section 10.03: Appeal of Individual Transitional Plan by Disabled Person 45 Section 10.04: Appeal of Individual Transitional Plan by State Agency 45 Section 10.05: Extension of Individual Transitional Plan 46 Section 10.06: Termination of Individual Transitional Plan 46

(101 CMR 11.00 THROUGH 13.00: RESERVED) 53

101 CMR 14.00: PILOT PROGRAM OF NUTRITIONAL ASSISTANCE 59

101 CMR 15.00: CRIMINAL OFFENDER RECORD CHECKS 61

Section 15.01: Purpose 61 Section 15.02: Policy 61 Section 15.03: Scope 61 Section 15.04: Definitions 62 Section 15.05: Community Service and Work Release Workers 64 Section 15.06: Application Forms 64 Section 15.07: CORI Investigations 65 Section 15.08: Findings from CORI Investigations – No Further Review – Outstanding Warrants 65 Section 15.09: Findings from CORI Investigation - Crimes Subject to Review 65 Section 15.10: Post Audit and Compliance Review 67 Section 15.11: Dissemination 67 Section 15.12: Incidents 67 Section 15.13: Agency Regulations 67 Section 15.14: Severability 67 Section 15.15: Tables of Offenses 68

101 CMR 16.00: PERSONAL DATA USE AND PERMITTED DISCLOSURES BY AND AMONG THE EXECUTIVE OFFICE OF HEALTH AND HUMAN SERVICES AND ITS AGENCIES 73

Section 16.01: Applicability 73 Section 16.02: Purpose 73 Section 16.03: Definitions 73 Section 16.04: Use or Disclosure of Personal Data by EOHHS 74 Section 16.05: Use or Disclosure of Personal Data Between and Among Agencies 74 Section 16.06: Use and Disclosure Only Within EOHHS Agencies 74 Section 16.07: Safeguarding Personal Data 74

101 CMR 17.00: UNIFIED PLANNING TEAMS 75

Section 17.01: Regulatory Authority 75 Section 17.02: Purpose 75 Section 17.03: Definition of Terms 75 Section 17.04: Referrals 76 Section 17.05: Eligibility for Review 76 Section 17.06: Unified Planning Team Review Process 77 Section 17.07: Appeal Process 78 Section 17.08: Implementation of Services 79 Section 17.09: Confidentiality 79

8/6/10 101 CMR -1 The text of the regulations published in the electronic version of the Massachusetts Register is unofficial and for informational purposes only. The official version is the printed copy which is available from the State Bookstore at http://www.sec.state.ma.us/spr/sprcat/catidx.htm. 101 CMR: EXECUTIVE OFFICE OF HEALTH AND HUMAN SERVICES

Table of Contents Page

(101 CMR 18.00 THROUGH 309.00: RESERVED) 81

101 CMR 310.00: ADULT DAY HEALTH SERVICES 601

Section 310.01: General Provisions 601 Section 310.02: General Definitions 601 Section 310.03: Rate Provisions 602 Section 310.04: Reporting Requirements 603 Section 310.05: Severability 604

(PAGES 3 AND 4 ARE RESERVED FOR FUTURE USE.)

2/1/13 101 CMR - 2 The text of the regulations published in the electronic version of the Massachusetts Register is unofficial and for informational purposes only. The official version is the printed copy which is available from the State Bookstore at http://www.sec.state.ma.us/spr/sprcat/catidx.htm. 101 CMR: EXECUTIVE OFFICE OF HEALTH AND HUMAN SERVICES

(101 CMR 18.00 THROUGH 309.00: RESERVED)

2/1/13 101 CMR - 81 The text of the regulations published in the electronic version of the Massachusetts Register is unofficial and for informational purposes only. The official version is the printed copy which is available from the State Bookstore at http://www.sec.state.ma.us/spr/sprcat/catidx.htm. 101 CMR: EXECUTIVE OFFICE OF HEALTH AND HUMAN SERVICES

(PAGES 83 THROUGH 600 ARE RESERVED FOR FUTURE USE.)

2/1/13 101 CMR - 82 The text of the regulations published in the electronic version of the Massachusetts Register is unofficial and for informational purposes only. The official version is the printed copy which is available from the State Bookstore at http://www.sec.state.ma.us/spr/sprcat/catidx.htm. 101 CMR: EXECUTIVE OFFICE OF HEALTH AND HUMAN SERVICES

101 CMR 310.00: ADULT DAY HEALTH SERVICES

Section

310.01: General Provisions 310.02: General Definitions 310.03: Rate Provisions 310.04: Reporting Requirements 310.05: Severability

310.01: General Provisions

(1) Scope, Purpose and Effective Date. 101 CMR 310.00 governs the payment rates effective October 1, 2012, for Adult Day Health Services provided to Publicly-aided Patients. The payment rates in 101 CMR 310.00 also apply to individuals covered by the Workers' Compensation Act, M.G.L. c. 152.

(2) Coverage. The payment rates in 101 CMR 310.00 are full compensation for adult day health services as well as for any related administrative or supervisory duties rendered in connection with the provision of Adult Day Health Services.

(3) Disclaimer of Authorization of Services. 101 CMR 310.00 is neither authorization for nor approval of the substantive services for which rates are determined pursuant to 101 CMR 310.00. Governmental Units or workers compensation insurers that purchase care are responsible for the definition, authorization, and approval of care and services to covered individuals.

(4) Administrative Bulletins. EOHHS may issue administrative bulletins to clarify its policy on and understanding of substantive provisions of 101 CMR 310.00.

(5) Authority. 101 CMR 310.00 is adopted pursuant to M.G.L. c. 118E.

310.02: General Definitions

As used in 101 CMR 310.00, terms will have the meaning set forth in 101 CMR 310.02.

Adult Day Health Services. Programs approved by the Office of Medicaid under 130 CMR 404.000: Adult Day Health Services and that provide for adult recipients an alternative to 24 hour long-term institutional care through an organized program of health care and supervision, restorative services and socialization.

Adult. Any person 18 years of age or older.

Basic Level of Care. The level of care for publicly-aided clients receiving Adult Day Health services as defined in the Office of Medicaid's Regulation 130 CMR 404.414(D)(2).

Center. The Center for Health Information and Analysis established under M.G.L. c. 12C.

Complex Level of Care. The level of care for publicly-aided clients receiving Adult Day Health services as defined in the Office of Medicaid's Regulation 130 CMR 404.414(D)(3).

Day Setting. Any single physical facility that is open at least Monday through Friday for eight hours per day that has been reviewed and approved by the Office of Medicaid and other proper authorities for the operation of adult day health services program.

Eligible Provider. Any person, partnership, corporation, or other entity that is authorized in the Commonwealth of Massachusetts to engage in the business of furnishing Adult Day Health Services to the public and who also meets such conditions of participation by a governmental unit.

EOHHS. The Executive Office of Health and Human Services established under M.G.L. c. 6A.

2/1/13 101 CMR - 601 The text of the regulations published in the electronic version of the Massachusetts Register is unofficial and for informational purposes only. The official version is the printed copy which is available from the State Bookstore at http://www.sec.state.ma.us/spr/sprcat/catidx.htm. 101 CMR: EXECUTIVE OFFICE OF HEALTH AND HUMAN SERVICES

310.02: continued

Fiscal Year. The 12 month period defined by an Eligible Provider as its accounting period.

Governmental Unit. The Commonwealth, any department, agency, Board or commission of the Commonwealth and any political subdivision of the Commonwealth.

Health Promotion and Prevention Level of Care. The level of care for publicly-aided clients receiving Adult Day Health services as defined in the Office of Medicaid's Regulation 130 CMR 404.414(D)(1).

Publicly-aided Individual. A person whose medical and other services a governmental unit is in whole or part liable for under a statutory program.

Restorative Services. Indirect services, including but not limited to, case conferences or those of an in-service educational therapist, speech pathologist, or other qualified restorative therapist.

310.03: Rate Provisions

(1) Covered Services. The payment rates in 101 CMR 310.00 apply to Adult Day Health Services provided by Eligible Providers in a Day Setting, where: (a) a patient's medical condition indicates a need for nursing care, supervision or a need for therapeutic services that alone or in combination would require institutional placement; or (b) a patient's psycho-social condition is such that without program intervention the patient's medical condition would continue to deteriorate or is such that institutional placement is imminent.

(2) Exclusions. The payments rates in 101 CMR 310.00 do not apply to the following circumstances and services: (a) specialized day programs primarily for the developmentally disabled, blind, deaf, or acutely mentally ill; (b) adult day health programs operating out of state; (c) physician services paid on a fee for service basis under 114.3 CMR 16.00: Surgery and Anesthesia Services and 114.3 CMR 17.00: Medicine; (d) restorative therapy services paid on a fee for service basis under 114.3 CMR 39.00: Rehabilitation Clinic Services, Audiological Services; Restorative Services; (e) transportation costs incurred by the Eligible Provider to and from the adult day health center; (f) services and costs paid under other regulations promulgated by EOHHS.

(3) Payment Rates. (a) The base rate for Adult Day Health Services is the lower of the established charge or the rate listed.

Code Per Day Base Rate Description S5102 $58.83 Basic Level of Care S5102 TG $74.50 Complex Level of Care S5102 U1 $30.05 Health Promotion and Prevention Level of Care

Code Per 15 Minute Base Rate Description S5100 $2.45 Basic Level of Care S5100 TG $3.10 Complex Level of Care S5100 U1 $1.25 Health Promotion and Prevention Level of Care

2/1/13 101 CMR - 602 The text of the regulations published in the electronic version of the Massachusetts Register is unofficial and for informational purposes only. The official version is the printed copy which is available from the State Bookstore at http://www.sec.state.ma.us/spr/sprcat/catidx.htm. 101 CMR: EXECUTIVE OFFICE OF HEALTH AND HUMAN SERVICES

310.03: continued

(b) FY 2013 Annualization Adjustment. For the period from October 1, 2012 through June 30, 2013, there will be an additional annualization adjustment as set forth:

Code Per Day Base Rate FY 2013 Annualization FY 2013 Total Description Adjustment Payment S5102 $58.83 $1.23 $60.06 Basic Level of Care S5102 TG $74.50 $1.45 $75.95 Complex Level of Care S5102 U1 $30.05 $0.55 $30.60 Health Promotion and Prevention Level of Care

Code Per 15 Minute Base FY2013 FY2013 Total Description Rate Annualization Payment Adjustment S5100 $2.45 $0.05 $2.50 Basic Level of Care S5100 TG $3.10 $0.06 $3.16 Complex Level of Care S5100 U1 $1.25 $0.02 $1.28 Health Promotion and Prevention Level of Care

310.04: Reporting Requirements

(1) Required Reports. An Eligible Provider that was paid by a Governmental Unit for Adult Day Health Services provided in a prior Fiscal Year, and whose program operated for the entire prior fiscal year must submit the following information to the Center. (a) A complete Adult Day Health Center Cost Report for the prior Fiscal Year; (b) Financial Statements certified by a certified public accountant. In the absence of certified statements, the eligible provider may submit uncertified financial statements or a Balance Sheet and Operating Statement prepared by the agency, and approved by the Center. (c) Any other data, information or cost reporting the Center may request. (d) Statistical data shall be designated by the Center, including but not limited to the total number of resident days.

(2) Due Date. The due date of the annual Adult Day Health Center Cost Report and Financial Statements is determined by the fiscal year of the filing provider. The Center may amend cost reporting requirements, including the due date of required reports, by an Administrative Bulletin. Eligible Providers must submit any other information requested by the Center within 90 days from the date of notification, unless otherwise specified by the Center.

(3) Additional Information. Each Eligible Provider shall also make available all records, books and reports relating to its operations, including such data and statistics as the Center may request.

(4) Extension and Alternative Cost Reporting Methods. Upon written request from a provider demonstrating that good cause exists, the Center may grant an extension of time for filing required reports or at its discretion may allow a provider to substitute other cost data than required in the adult day cost report.

2/1/13 101 CMR - 603 The text of the regulations published in the electronic version of the Massachusetts Register is unofficial and for informational purposes only. The official version is the printed copy which is available from the State Bookstore at http://www.sec.state.ma.us/spr/sprcat/catidx.htm. 101 CMR: EXECUTIVE OFFICE OF HEALTH AND HUMAN SERVICES

310.04: continued

(5) Penalty for Non-compliance. EOHHS may reduce the payment rates by 15% for any Provider that fails to submit required information to the Center. EOHHS will notify the Provider in advance of its intention to impose a rate reduction. The rate reduction will remain in effect until the Center receives the required information.

310.05: Severability

The provisions of 101 CMR 310.00 are hereby declared to be severable and if any such provisions or the application of such provisions to any person or circumstances shall be held to be invalid or unconstitutional, such invalidity shall not be construed to affect the validity or constitutionality of any remaining provisions to eligible providers or circumstances other than those held invalid.

REGULATORY AUTHORITY

101 CMR 310.00: M.G.L. chs. 118E and 12C.

2/1/13 101 CMR - 604 The text of the regulations published in the electronic version of the Massachusetts Register is unofficial and for informational purposes only. The official version is the printed copy which is available from the State Bookstore at http://www.sec.state.ma.us/spr/sprcat/catidx.htm. Docket # 1,121

THE COMMONWEALTH OF MASSACHUSETTS William Francis Galvin Secretary of the Commonwealth

Regulation Filing To be completed by filing agency

CHAPTER NUMBER: 105 CMR 700.000

CHAPTER TITLE: Implementation of M.G.L. c. 94C

AGENCY: Department of Public Health

SUMMARY OF REGULATION: State the general requirements and purposes of this regulation. The regulation governs implementation of the Controlled Substances Act. These amendments (1) ensure that the requirements for the prescription monitoring program (PMP) are consistent with statutory requirements, (2) ensure that the requirements for the prescriptive practice of nurse midwives are consistent with statutory requirements, and (3) expand the Medication Administration Program (MAP) to facilities administered by the Department of Children and Families.

REGULATORY AUTHORITY: M.G.L. c. 94C, ss. 6, 7, 24A

AGENCY CONTACT: Alison J. Mehlman PHONE: 617-624-5232

ADDRESS: 250 Washington St., Boston, MA 02108

Compliance with M.G.L. c. 30A

EMERGENCY ADOPTION - if this regulation is adopted as an emergency, state the nature of the emergency.

PRIOR NOTIFICATION AND/OR APPROVAL - If prior notification to and/or approval of the Governor, Legislature or others was required, list each notification, and/or approval and date, including notice to the Local Government Advisory Commission. Massachusetts Municipal Association: 3/30/12, 4/19/12 Executive Office of Communities and Development: 3/30/12, 4/19/12

Date of public hearing or comment period: 7/20/12, 9/7/12, 11/9/12

Date amended small business impact statement was filed: 1/15/13

CODE OF MASSACHUSETTS REGULATIONS INDEX - List key subjects that are relevant to this regulation: Controlled Substances

ATTESTATION - The regulation described herein and attached hereto is a true copy of the regulation adopted by this agency. ATTEST:

SIGNATURE: SIGNATURE ON FILE DATE: Jan 17 2013

Publication - To be completed by the Regulations Division

MASSACHUSETTS REGISTER NUMBER: 1227 DATE: 02/01/2013

EFFECTIVE DATE: 02/01/2013

CODE OF MASSACHUSETTS REGULATIONS Remove these pages: Insert these pages: 93, 94 93, 94 3975 - 3988 3975 - 3988 3993, 3994 3993, 3994 4002.1 - 4002.4 4002.1 - 4002.4 01/17/2013 mrs

Table of Contents Page

(105 CMR 676.000 through 679.000: RESERVED) 3945

105 CMR 680.000: PHOSPHATES IN HOUSEHOLD CLEANSING PRODUCTS 3951

Section 680.001: Purpose 3951 Section 680.002: Authority 3951 Section 680.003: Definitions 3951 Section 680.004: Sale, Offering, Distribution and Use of House- hold Cleansing Products Containing Phosphorus 3952 Section 680.005: Recordkeeping and Reporting Requirements 3953 Section 680.006: Industrial Use Exemptions 3954 Section 680.007: Availability of Household Cleansing Product Information and Protection of Trade Secret Information 3956 Section 680.008: Penalties 3957 Section 680.009: Severability 3957

(105 CMR 681.000 through 699.000: RESERVED) 3959

105 CMR 700.000: IMPLEMENTATION OF M.G.L. c. 94C 3975

Section 700.001: Definitions 3975 Section 700.002: Schedules of Controlled Substances 3981 Section 700.003: Registration of Persons for a Specific Activity or Activities in Accordance with M.G.L. c. 94C, § 7(g) 3982 Section 700.004: Registration Requirements 3990 Section 700.005: Security Requirements 3995 Section 700.006: Requirements for Records, Inventories, and Reports 3996 Section 700.007: Inspection of Premises 3999 Section 700.008: Requirements Regarding Hypodermic Instruments 3999 Section 700.009: Research Involving Controlled Substances 4000 Section 700.010: Dispensing and Labeling of Sample Medications by Practitioners 4002 Section 700.011: Issuance of Prescriptions or Medication Orders for Implantable Infusion Pumps Containing Schedule II or Schedule III Controlled Substance 4002.1 Section 700.012: Prescription Monitoring Program 4002.1 Section 700.020: Severability 4002.4

105 CMR 701.000: REGULATIONS ADOPTED JOINTLY BY THE DEPARTMENT OF PUBLIC HEALTH AND THE BOARD OF REGISTRATION IN PHARMACY FOR THE IMPLEMENTATION OF M.G.L. c. 94C 4003

Section 701.001: Excluded Non-Narcotic Substances 4003 Section 701.002: Excepted Compounds 4004 Section 701.003: Emergency Situations in Which Controlled Substances in Schedule II May Be Dispensed upon Oral Prescription 4029 Section 701.004: Requirements for Positive Identification for Dispensing of a Controlled Substance in Schedule II through V 4030

(105 CMR 702.000 through 719.000: RESERVED) 4031

2/1/13 105 CMR - 93 The text of the regulations published in the electronic version of the Massachusetts Register is unofficial and for informational purposes only. The official version is the printed copy which is available from the State Bookstore at http://www.sec.state.ma.us/spr/sprcat/catidx.htm. 105 CMR: DEPARTMENT OF PUBLIC HEALTH

Table of Contents Page

105 CMR 720.000: LIST OF INTERCHANGEABLE DRUG PRODUCTS 4101

Section 720.001: Purpose 4101 Section 720.002: Citation 4101 Section 720.010: Scope and Application 4101 Section 720.020: Definitions 4101

Standards Section 720:040: Commission Review of Relevant Drug Products 4102 Section 720.050: List of Interchangeable Drug Products 4103 Section 720.060: Drug Products Excluded 4103 Section 720.070: Amendments to the Massachusetts List of Interchangeable Drugs 4103

Procedures for Amending List of Interchangeable Drug Products Section 720.080: Procedures for Amending the Massachusetts List of Interchangeable Drugs 4103 Section 720.081: Petition to Amend List of Interchangeable Drug Products 4104 Section 720.082: Commission Review of Petition 4104 Section 720.083: Notice of Public Comment Period 4104 Section 720.084: Commission Recommendation of Amendments to Department 4104 Section 720.090: Department Adoption of Amendments 4104 Section 720.100: Severability 4104 Section 720.200: Appendix A: List of Interchangeable Drugs 4105

105 CMR 721.000: STANDARDS FOR PRESCRIPTION FORMAT AND SECURITY IN MASSACHUSETTS 4133

Section 721.001: Purpose 4133 Section 721.002: Citation 4133 Section 721.003: Scope and Application 4133 Section 721.010: Definitions 4133 Section 721.020: Prescription Formats 4133 Section 721.030: Security Standards for Prescriptions 4134 Section 721.040: Invalid Prescriptions 4135 Section 721.050: Prescribing More than One Product 4135

2/13/04 105 CMR - 94 The text of the regulations published in the electronic version of the Massachusetts Register is unofficial and for informational purposes only. The official version is the printed copy which is available from the State Bookstore at http://www.sec.state.ma.us/spr/sprcat/catidx.htm. 105 CMR: DEPARTMENT OF PUBLIC HEALTH

105 CMR 700.000: IMPLEMENTATION OF M.G.L. c. 94C

Section

700.001: Definitions 700.002: Schedules of Controlled Substances 700.003: Registration of Persons for a Specific Activity or Activities in Accordance with M.G.L. c. 94C, § 7(g) 700.004: Registration Requirements 700.005: Security Requirements 700.006: Requirements for Records, Inventories, and Reports 700.007: Inspection of Premises 700.008: Requirements Regarding Hypodermic Instruments 700.009: Research Involving Controlled Substances 700.010: Dispensing and Labeling of Samples Medications by Practitioners 700.011: Issuance of Prescriptions or Medication Orders for Implantable Infusion Pumps Containing Schedule II or Schedule III Controlled Substance 700.012: Prescription Monitoring Program 700.020: Severability

700.001: Definitions

For the purpose of 105 CMR 700.000, the following definitions apply, in addition to those definitions appearing in M.G.L. c. 94C, § 1, unless the context or subject matter requires a different meaning.

Additional Drug means a controlled substance in Schedule VI determined by the Department to carry a bona fide potential for abuse.

Administer means the direct application of a controlled substance whether by injection, inhalation, ingestion or any other means to the body of a patient or research subject by: (1) A practitioner; or (2) A registered nurse or licensed practical nurse at the direction of a practitioner in the course of his or her professional practice; or (3) An ultimate user or research subject at the direction of a practitioner in the course of his or her professional practice.

Agent means an authorized person who acts on behalf of or at the direction of a manufacturer, distributor or dispenser; except that such term does not include a common or contract carrier, public warehouseman or employee of the carrier or warehouseman, when acting in the usual and lawful course of the carrier's or warehouseman's business.

Ambulance Service means an entity licensed as an ambulance service by the Department in accordance with M.G.L. c. 111C, § 6 and 105 CMR 170.000: Emergency Medical Services System.

Chemical Analyst means a person engaged in the qualitative or quantitative analysis of controlled substances within a scientific laboratory.

Chronic Patient means, for the purposes of 105 CMR 700.000 only, a person diagnosed by a physician as having a physical or mental illness characterized by slow progress and long continuance.

Commissioner means the Commissioner of Public Health or his or her duly authorized agent.

Community Program means any community residential or day program that is funded, operated or licensed by the Massachusetts Department of Mental Health, Department of Developmental Services, or Department of Children and Families, with the exception of programs funded under Title XIX of the Social Security Act.

Controlled Substance means a drug, substance, or immediate precursor in any schedule or class referred to in M.G.L. c. 94C or 105 CMR 700.000.

2/1/13 105 CMR - 3975 The text of the regulations published in the electronic version of the Massachusetts Register is unofficial and for informational purposes only. The official version is the printed copy which is available from the State Bookstore at http://www.sec.state.ma.us/spr/sprcat/catidx.htm. 105 CMR: DEPARTMENT OF PUBLIC HEALTH

700.001: continued

Compounding means in the definition of "Manufacture", compounding a controlled substance other than: (1) By a practitioner; or (2) By a pharmacist subject to a prescription.

Customer Identifier means the identification number on a valid government issued identification, as specified by the Department, which a pharmacy obtains by inspecting the identification of the ultimate user or agent of the ultimate user to whom a prescription is dispensed.

Deliver means to transfer, whether by actual or constructive transfer, a controlled substance from one person to another, whether or not there is an agency relationship.

Dental Hygienist means a person registered by the Board of Registration in Dentistry pursuant to M.G.L. c. 112, § 51.

Department means the Department of Public Health.

Department of Children and Families means the Massachusetts Department of Children and Families.

Department of Developmental Services means the Massachusetts Department of Developmental Services.

Department of Mental Health means the Massachusetts Department of Mental Health.

Depressant or Stimulant Substance means: (1) A drug which contains any quantity of barbituric acid or any of the salts of barbituric acid; or any derivative of barbituric acid which the United States Secretary of Health, Education and Welfare has by regulation designated as habit forming; or (2) A drug which contains any quantity of amphetamine or any of its optical isomers; any salt of amphetamine or any salt of an optical isomer of amphetamine; or any substance which the United States Attorney General has by regulation designated as habit forming because of its stimulant effect on the central nervous system; or (3) Lysergic acid diethylamide; or (4) Any drug except marihuana which contains any quantity of a substance which the United States Attorney General has by regulation designated as having a potential for abuse because of its depressant or stimulant effect on the central nervous system or its hallucinogenic effect.

Dispense means to deliver a controlled substance to an ultimate user or research subject or to the agent of an ultimate user or research subject by a practitioner or pursuant to the order of a practitioner, including the prescribing and administering of a controlled substance and the packaging, labeling, or compounding necessary for such delivery.

Distribute means to deliver other than by administering or dispensing a controlled substance.

Drug means: (1) Substances recognized as drugs in the official United States Pharmacopoeia, official Homeopathic Pharmacopoeia of the United States or official National Formulary or any supplement to any of them; (2) Substances intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in man or animals; (3) Substances, other than food, intended to affect the structure or any function of the body of man and animals; or (4) Substances intended for use as a component of any article specified in 105 CMR 700.001(M)(1) through (3), exclusive of devices or their components, parts or accessories.

Drug Enforcement Administration means the United States Drug Enforcement Administration in the United States Department of Justice, or its successor agency.

2/1/13 105 CMR - 3976 The text of the regulations published in the electronic version of the Massachusetts Register is unofficial and for informational purposes only. The official version is the printed copy which is available from the State Bookstore at http://www.sec.state.ma.us/spr/sprcat/catidx.htm. 105 CMR: DEPARTMENT OF PUBLIC HEALTH

700.001: continued

EMS First Responder (EFR) means a person certified as an EFR by the Department, in accordance with M.G.L. c. 111C, § 9 and 105 CMR 170.000: Emergency Medical Services System, and authorized to administer controlled substances pursuant to his or her certification and the Statewide Treatment Protocols.

EMS First Response Service (EFR Service) means an entity licensed as an EFR service by the Department in accordance with M.G.L. c. 111C, § 6 and 105 CMR 170.000: Emergency Medical Services System.

Emergency Medical Technician (EMT) means a person certified by the Department, pursuant to M.G.L. c. 111C, § 9 and 105 CMR 170.000: Emergency Medical Services System, in accordance with his or her level of training, to administer controlled substances pursuant to his or her training and the Statewide Treatment Protocols. The term EMT shall include EMT-Basic and the ALS levels of EMT-Intermediate and EMT-Paramedic as defined in 105 CMR 170.000.

First Responder means a First Responder as defined in M.G.L. c. 111, § 201 and 105 CMR 171.000: Massachusetts First Responder Training, and who is authorized to administer controlled substances in accordance with 105 CMR 171.000, his or her training thereunder and the Statewide Treatment Protocols.

Fluoride Program Monitor means a dental assistant, school teacher, school aide or school volunteer.

Health Facility means: (1) A hospital, hospital pharmacy, long-term care facility, or clinic or institution for unwed mothers, infirmary maintained in a town, convalescent home, nursing home or charitable home for the aged, licensed or maintained by the Department; or (2) A public medical institution as defined in M.G.L. c. 118E, § 2; or (3) Any institution licensed or maintained by the Department of Mental Health; (4) Any hospital, long-term care facility or clinic maintained by the Commonwealth; or (5) Any ambulance service licensed by the Department to provide Advanced Life Support services.

Home Care Setting means any place where a person resides which is not licensed or funded by the Commonwealth to provide institutional care or custody. Home care settings include, but are not limited to the following: (1) an individual's private home; (2) community residences or group homes licensed or funded by an agency of the commonwealth; (3) shelters and day centers for the homeless; and (4) hospice settings which are approved by the Department and which are not licensed to provide acute care or operated by a hospital so licensed.

Hospital means any institution, however named, whether conducted for charity or for profit, which is advertised, announced, established or maintained for the purpose of caring for persons admitted thereto for diagnosis, medical, surgical or restorative treatment which is rendered within said institution.

Immediate Precursor means a substance which the Commissioner has found to be and by rule designates as being the principal compound commonly used or produced primarily for use, and which is an immediate chemical intermediary used or likely to be used in the manufacture of a controlled substance, the control of which is necessary to prevent, curtail or limit manufacture.

Implantable Infusion Pump means a device that is intended to be implanted in the human body for the purpose of delivering a controlled flow of drug(s).

Institutionalization means admission on an inpatient basis to in one of the following settings: (1) long-term care facilities, as that term is defined in 105 CMR 700.000; (2) hospitals, as that term is defined in 105 CMR 700.000.

2/1/13 105 CMR - 3977 The text of the regulations published in the electronic version of the Massachusetts Register is unofficial and for informational purposes only. The official version is the printed copy which is available from the State Bookstore at http://www.sec.state.ma.us/spr/sprcat/catidx.htm. 105 CMR: DEPARTMENT OF PUBLIC HEALTH

700.001: continued

Investigation means, for the purpose of 105 CMR 700.012(D)(2), an inquiry, appropriate to agency authority, that has been opened previously, is ongoing, has been undertaken with a stated purpose and is based on a complaint, allegation, evidence or other useful information concerning a potential violation of law or regulation by a specific prescriber, pharmacy, or patient or other individual to whom a controlled substance has reportedly been dispensed.

Isomer means the optical isomer, except that wherever appropriate it shall mean the optical, position or geometric isomer.

Labeling means in the definition of "manufacture", labeling or relabeling other than: (1) By a practitioner, or (2) By a pharmacist.

Long-term Care Facility means any institution whether conducted for charity or profit, which is advertised, announced or maintained for the express or implied purpose of providing three or more individuals admitted thereto with long-term resident, nursing, convalescent or rehabilitative care; supervision and care incident to old age for ambulatory persons; or retirement home care for elderly persons. For the purposes of 105 CMR 700.000 only, long-term care facility shall include hospitals which are licensed solely to provide chronic and/or rehabilitative care, state schools for mentally retarded persons, state hospitals for mentally ill persons, convalescent or nursing homes, rest homes, infirmaries maintained in towns and charitable homes for the aged. (1) "Convalescent or nursing homes, rest homes, infirmaries maintained in a town, and charitable homes for the aged" shall have the same meanings as those terms defined in M.G.L. c. 111, § 71. (2) "Long-term Care" means care of significant duration, as distinguished from acute short-term care provided in a general hospital, and shall not include care provided in a hospital licensed to provide acute care.

Manufacture means the production, preparation, propagation, compounding, conversion or processing of a controlled substance, either directly or indirectly by extraction from substances of natural origin or independently by means of chemical synthesis, including any packaging or repackaging of the substance or labeling or relabeling of its container except that this term does not include the preparation or compounding of a controlled substance by an individual for his or her own use or the preparation, compounding, packaging or labeling of a controlled substance: (1) By a practitioner as an incident to his or her administering a controlled substance in the course of his professional practice, or (2) By a practitioner, or by his or her authorized agent under his or her supervision, for the purpose of, or as an incident to, research, teaching or chemical analysis and not for sale.

Marihuana means all parts of the plant Cannabis sativa L., whether growing or not; the seeds thereof; and resin extracted from any part of the plant; and every compound, manufacture, salt, derivative, mixture or preparation of the plant, its seeds or resin. It does not include the mature stalks of the plant, fiber produced from the stalks, oil or cake made from the seeds of the plant, any other compound, manufacture, salt derivative, mixture or preparation of the mature stalks, except the resin extracted therefrom, fiber, oil or cake of the sterilized seed of the plant which is incapable of germination.

Medication Order means a written order for a medication entered on a patient's medical record maintained at a hospital, other health facility, or ambulatory health care setting and is dispensed for immediate administration to the ultimate user by an individual authorized by M.G.L. c. 94C to administer such medication.

Narcotic Drug means any of the following, whether produced directly or indirectly by extraction from substances of vegetable origin, or independently by means of chemical synthesis, or by a combination of extraction and chemical synthesis: (1) Opium and opiate, and any salt, compound, derivative, or preparation of opium or opiate; (2) Any salt, compound, isomer, derivative or preparation thereof which is chemically equivalent or identical with any of the substances referred to in 105 CMR 700.001(T)(1), but not including the isoquinoline alkaloids of opium; (3) Opium poppy and poppy straw;

2/1/13 105 CMR - 3978 The text of the regulations published in the electronic version of the Massachusetts Register is unofficial and for informational purposes only. The official version is the printed copy which is available from the State Bookstore at http://www.sec.state.ma.us/spr/sprcat/catidx.htm. 105 CMR: DEPARTMENT OF PUBLIC HEALTH

700.001: continued

(4) Coca leaves and any salt, compound, derivative, or preparation of coca leaves, and any salt, compound, isomer, derivative or preparation thereof which is chemically equivalent or identical with any of these substances, but not including decocainized coca leaves or extractions of coca leaves which do not contain cocaine or ecgonine.

National Association of Boards of Pharmacy (NABP) Number means a unique seven digit number issued by the National Council for Prescription Drug Programs (NCPDP).

National Drug Code Number (NDC) means a nationally recognized standard which identifies drug products using a unique number, issued by the United States Food and Drug Administration, involving three components. The first component identifies the drug manufacturer ("LABELER NO.") the second identifies the product ("PRODUCT NO."), the third identifies the package size ("PKG").

Non-self-administering means personally taking or applying a controlled substance in the manner directed by the prescribing practitioner, with more than minimal assistance or direction by the program staff, as determined in accordance with procedures and criteria established by the Department of Mental Health, Department of Developmental Services, or Department of Children and Families and approved by the Department of Public Health.

Nurse Anesthetist means a registered nurse authorized to practice as a nurse anesthetist by the Board of Registration in Nursing as provided for in M.G.L. c. 112, § 80B and 244 CMR 4.00: The Practice of Nursing in the Expanded Role, most specifically 244 CMR 4.11 through 4.27.

Nurse Midwife means a registered nurse authorized to practice as a certified nurse midwife by the Board of Registration in Nursing as provided for in M.G.L. c. 112, § 80B and 244 CMR 4.00: The Practice of Nursing in the Expanded Role, most specifically 244 CMR 4.11 through 4.27

Nurse Practitioner means a registered nurse authorized to practice as a nurse practitioner by the Board of Registration in Nursing as provided for in M.G.L. c. 112, § 80B and 244 CMR 4.00: The Practice of Nursing in the Expanded Role, most specifically 244 CMR 4.11 through 4.27.

Opiate means any substance having an addiction-forming or addiction-sustaining liability similar to morphine or being capable of conversion into a drug having addiction-forming or addiction-sustaining liability. It does not include, unless specifically designated as controlled under M.G.L. c. 94C, § 2, the dextrorotatory isomer of 3-methoxy-n-methyl-morphinan and its salts, dextromethorphan. It does include its racemic and levorotatory forms.

Opium Poppy means the plant of the species Papaver somniferum L., except its seeds.

Oral Prescription means an oral order for medication which is dispensed to or for an ultimate user, but not including an order for medication which is dispensed for immediate administration to the ultimate user by a practitioner, registered nurse, or practical nurse.

Packaging means in the definition of "manufacture", packaging or repackaging a controlled substance other than: (1) By a practitioner or, (2) By a pharmacist.

Person means individual, corporation, government, governmental subdivision or agency, business trust, estate, trust, partnership, association, or any other legal entity.

Pharmacist means a pharmacist duly licensed by the Board of Registration in Pharmacy in accordance with M.G.L. c. 112, § 24 and 247 CMR 3.00: Personal Registration Requirements.

Physician Assistant means a physician assistant authorized to practice by the Board of Registration of Physician Assistants, as provided for in accordance with M.G.L. c. 112, § 9I and authorized to prescribe by St. 1991, c. 445, § 7(g) in accordance with 263 CMR 2.00: Purpose, Authority and Definitions.

2/1/13 105 CMR - 3979 The text of the regulations published in the electronic version of the Massachusetts Register is unofficial and for informational purposes only. The official version is the printed copy which is available from the State Bookstore at http://www.sec.state.ma.us/spr/sprcat/catidx.htm. 105 CMR: DEPARTMENT OF PUBLIC HEALTH

700.001: continued

Poppy Straw means all parts, except the seeds of the opium poppy, after mowing.

Practical Nurse means a nurse who is licensed pursuant to the provisions of M.G.L. c. 112, § 74A.

Practitioner means: (1) A physician, dentist, veterinarian, podiatrist, scientific investigator or other person registered to distribute, dispense, conduct research with respect to, or use in teaching or chemical analysis, a controlled substance in the course of professional practice or research in the commonwealth; (2) A pharmacy, hospital or other institution registered to distribute, dispense, conduct research with respect to or to administer a controlled substance in the course of professional practice or research in the commonwealth. (3) An optometrist authorized by M.G.L. c. 112, §§ 66 and 66B and registered pursuant to M.G.L. c. 94C, § 7(h) to utilize and prescribe topical therapeutic pharmaceutical agents, as defined in M.G.L. c. 112, § 66B, in the course of professional practice in the commonwealth.

Private School means the board of trustees, board of directors or comparable board responsible for operating a private elementary or secondary school program.

Prescription Drug means drug upon which the manufacturer or distributor has, in compliance with federal laws and regulations, placed the following: "Rx Only".

Psychiatric Nurse means a registered nurse authorized to practice as a psychiatric nurse mental health clinical specialist by the Board of Registration in Nursing, as provided for in M.G.L. c. 112, § 80B and 244 CMR 4.00: The Practice of Nursing in the Expanded Role, most specifically 244 CMR 4.11 through 4.27.

Registered Individual Practitioner shall mean a physician, dentist, veterinarian, podiatrist, nurse midwife, nurse practitioner, psychiatric nurse, nurse anesthetist or physician assistant who is registered pursuant to 105 CMR 700.004.

Registered Nurse means a nurse who is registered pursuant to the provisions of M.G.L. c. 112, § 74.

Registrant means a person who is registered pursuant to any provision of M.G.L. c. 94C.

Registration means unless the context specifically indicates otherwise such registration as is required and permitted only pursuant to the provisions of M.G.L. c. 94C.

Registration Number means the unique registration number required with respect to a practitioner by, and assigned to a practitioner by, the Drug Enforcement Administration or by the Department of Public Health or both.

Researcher means a person who engages in or conducts research involving substances, whether controlled or not, which are being used or are to be used on humans.

Sample Medication for the purpose of 105 CMR 700.000 shall mean a unit of prescription drug distributed by the manufacturer or distributor to practitioners in the original package from the manufacturer, not repackaged and given free of charge to patients. Such medications shall include but not be limited to those medications dispensed as part of an indigent patient drug program.

Schedule means the list of controlled substances established by the Commissioner pursuant to the provisions of M.G.L. c. 94C, § 2 for purposes of administration and regulation.

School means a public or private elementary or secondary school, or day care center or group care facility licensed by the Office for Children in accordance with M.G.L. c. 28A, § 10.

School District means the local educational agency, which includes the school committee, board of trustees, educational collaborative board, or other public entity responsible for operating a public elementary or secondary school program.

2/1/13 105 CMR - 3980 The text of the regulations published in the electronic version of the Massachusetts Register is unofficial and for informational purposes only. The official version is the printed copy which is available from the State Bookstore at http://www.sec.state.ma.us/spr/sprcat/catidx.htm. 105 CMR: DEPARTMENT OF PUBLIC HEALTH

700.001: continued

Scientific Laboratory means a facility maintained primarily for the analysis or examination of controlled substances or their precursors, and which is not a facility or part of a facility otherwise registered to manufacture, distribute, dispense or possess controlled substances.

Self-administering means personally taking or applying a controlled substance in the manner directed by the prescribing practitioner, with no more than minimal assistance or direction from program staff, in accordance with procedures and criteria established by the Department of Mental Health, Department of Developmental Services, or Department of Children and Families and approved by the Department of Public Health.

Statewide Treatment Protocols means the Emergency Medical Service Pre-hospital Treatment Protocols approved by the Department for application statewide in accordance with M.G.L. c. 111C and 105 CMR 170.000: Emergency Medical Services System.

Supervising Physician means a physician who provides supervision to a physician assistant, nurse practitioner, psychiatric nurse, pharmacist or nurse anesthetist in accordance with M.G.L. c. 112, §§ 2 through 12CC and 243 CMR 2.00: The Practice of Medicine.

Teacher means a person who conducts teaching activities using controlled substances in a teaching institution accredited by the Commission on Institutions of Higher Education.

Tetrahydrocannabinol means tetrahydrocannabinol or preparations containing tetrahydrocannabinol excluding marihuana except when it has been established that the concentration of delta-9 tetrahydrocannabinol in said marihuana exceeds 2½%.

Ultimate User means a person who lawfully possesses a controlled substance for his or her own use or for the use of a member of his or her household or for administering to an animal owned by him or her or by a member of his or her household.

Universal Claim Form (UCF) means a nationally recognized standard form developed by the National Council for Prescription Drug Programs, used for billing prescription drug claims to insurance plans and available through the pharmacy's local wholesaler.

Written Prescription means a lawful order from a practitioner for a drug or device for a specific patient that is communicated directly to a pharmacist in a licensed pharmacy, including an electronic prescription; provided, however, that "written prescription" shall not include an order for medication which is dispensed for immediate administration to the ultimate user by a practitioner, registered nurse or practical nurse.

700.002: Schedules of Controlled Substances

The following schedules of controlled substances are established:

(A) Schedule I. Schedule I shall consist of the drugs and other substances, by whatever official name, common or usual name, chemical name, or brand name designated, listed in 21 CFR 1308.11.

(B) Schedule II. Schedule II shall consist of the drugs and other substances, by whatever official name, common or usual name, chemical name, or brand name designated, listed in 21 CFR 1308.12.

(C) Schedule III. Schedule III shall consist of the drugs and other substances, by whatever official name, common or usual name, chemical name, or brand name designated, listed in 21 CFR 1308.13.

(D) Schedule IV. Schedule IV shall consist of the drugs and other substances, by whatever official name, common or usual name, chemical name, or brand name designated, listed in 21 CFR 1308.14.

2/1/13 105 CMR - 3981 The text of the regulations published in the electronic version of the Massachusetts Register is unofficial and for informational purposes only. The official version is the printed copy which is available from the State Bookstore at http://www.sec.state.ma.us/spr/sprcat/catidx.htm. 105 CMR: DEPARTMENT OF PUBLIC HEALTH

700.002: continued

(E) Schedule V. Schedule V shall consist of the drugs and other substances, by whatever official name, common or usual name, chemical name, or brand name designated, listed in 21 CFR 1308.15.

(F) Schedule VI. Schedule VI shall consist of all prescription drugs, which are not included in any other schedule established by the Commissioner.

700.003: Registration of Persons for a Specific Activity or Activities in Accordance with M.G.L. c. 94C, § 7(g)

(A)(1) An EMT-Paramedic, or an EMT-Paramedic student as part of his or her participation in a Department-approved Paramedic training program, may administer only those controlled substances, in quantity and kind, that are necessary for the performance of his or her duties; (2) An EMT-Intermediate, EMT-Intermediate student as part of his or her participation in a Department-approved Intermediate training program, EMT-Basic or EFR may administer only those controlled substances in Schedule VI for which he or she has been approved by the Department and that are necessary for the performance of his or her duties; (3) Administration of controlled substances by an EMT, EMT-Paramedic student, EMT- Intermediate student or EFR is also subject to the following conditions: (a) The ambulance service or EFR service for which the individual serves, shall be registered in accordance with 105 CMR 700.004 for the appropriate controlled substances; (b) The ambulance service or EFR service shall maintain a current listing of names of its employees and volunteers who are authorized to administer controlled substances; (c) The EMT, EMT-Paramedic student, EMT-Intermediate student or EFR shall perform only those functions for which he or she is authorized by, and trained in accordance with 105 CMR 170.000: Emergency Medical Services System; (d) Administration of controlled substances shall be conducted: 1. pursuant to the order of a practitioner and the Statewide Treatment Protocols; and 2. in accordance with 105 CMR 170.000: Emergency Medical Services System and the provisions of the Statewide Treatment Protocols.

(B) Dental hygienists and fluoride program monitors employed by or affiliated with a registered school may administer fluoride tablets or fluoride mouth rinse to school children aged three through 18 provided that: (1) The school has registered with the Department by sending a letter of intent to administer fluoride treatments to the Division of Dental Health and by providing whatever further information the Commissioner may require; and (2) The child's parent or guardian has been informed in writing of the nature, dose and effects of fluoride tablets and mouthrinse, and has consented in writing to the administration of fluoride tablets or mouthrinse on behalf of the child; and (3) The tablets or mouthrinse is administered in accordance with the order of a physician or dentist employed by or associated with a local Board of Health or school; and (4) The fluoride program monitor has been trained to administer and store fluoride tablets and mouthrinse in accordance with a training program designed by the Commissioner; and (5) All fluoride mouthrinse and tablets possessed by the registered school are stored securely under lock and key; and (6) The registered school maintains such records and files such reports concerning the fluoride program as the Commissioner may require.

(C) (1) A nurse practitioner, psychiatric nurse, nurse anesthetist or physician assistant may issue written prescriptions and medication orders for Schedule II through VI controlled substances, provided that the following requirements are met: (a) The nurse practitioner, nurse anesthetist and psychiatric nurse meets all requirements set forth in 244 CMR 4.00: The Practice of Nursing in the Expanded Role and M.G.L. c. 112, §§ 80B, 80E, and 80H. (b) The physician assistant meets all requirements set forth in regulations established by the Board of Registration of Physician Assistants, 263 CMR 2.00: Purpose, Authority and Definitions and M.G.L. c. 13, § 10B and M.G.L. c. 112, §§ 9C through 9K.

2/1/13 105 CMR - 3982 The text of the regulations published in the electronic version of the Massachusetts Register is unofficial and for informational purposes only. The official version is the printed copy which is available from the State Bookstore at http://www.sec.state.ma.us/spr/sprcat/catidx.htm. 105 CMR: DEPARTMENT OF PUBLIC HEALTH

700.003: continued

(c) The nurse practitioner, psychiatric nurse, nurse anesthetist or physician assistant registers with the Department's Division of Food and Drugs, in accordance with 105 CMR 700.004 and with the Drug Enforcement Administration, in accordance with 21 CFR 1300. (d) The nurse practitioner, psychiatric nurse, nurse anesthetist or physician assistant practices in accordance with written guidelines governing the prescription of medication mutually developed and agreed upon by the nurse practitioner, psychiatric nurse, nurse anesthetist or physician assistant and a supervising physician pursuant to regulations promulgated under M.G.L. c. 112, §§ 80B, 80E, and 80H and M.G.L. c. 112, § 9E that describes the methods to be followed in managing a health care situation or in resolving a health care problem. All prescriptions issued by the nurse practitioner, psychiatric nurse, nurse anesthetist or physician assistant are consistent with the scope of practice as defined by 244 CMR 4.26 for nurses practicing in the expanded role and 263 CMR 5.00: Scope of Practice and Employment of Physician Assistants for physician assistants. (e) The nurse practitioner, psychiatric nurse, nurse anesthetist or physician assistant may order controlled substances in Schedule VI from a drug wholesaler, manufacturer, laboratory or distributor. For the purpose of dispensing medication in Schedules II-V for immediate treatment, the nurse practitioner, psychiatric nurse, nurse anesthetist or physician assistant may obtain such medication only as supplied by the supervising physician, obtained through a written prescription for the patient, or in the case of a nurse anesthetist, as supplied by a practitioner for immediate treatment of a patient, in accordance with guidelines of the Board of Registration in Medicine. (f) A nurse practitioner, psychiatric nurse, nurse anesthetist or physician assistant may issue oral prescriptions in accordance with M.G.L. c. 94C, § 20, provided that the person issuing the prescription clearly identifies his or her name and professional designation to the pharmacist and provides his or her registration number, work address, phone number, and the name of the supervising physician. An oral prescription shall be followed up with a written prescription by the nurse practitioner, psychiatric nurse, nurse anesthetist or physician assistant to be provided to the pharmacist or postmarked within a period of not more than seven days or such shorter period as required by federal law, in accordance with M.G.L. c. 94C, § 20. (g) A nurse practitioner, psychiatric nurse, nurse anesthetist or physician assistant may prescribe controlled substances for a patient in a health facility or other setting through use of written medication orders entered on the patient's medical record maintained at the facility, provided that such written orders meet all applicable provisions of 105 CMR 700.000. (2) A nurse midwife may issue written prescriptions and medication orders, in accordance with the provisions of M.G.L. c. 112, §§ 80C and 80G, for those controlled substances in Schedules II through VI.

(D) Persons specified in 105 CMR 700.003(D) may administer epinephrine or atropine, pralidoxime chloride or other designated nerve agent antidotes in a life threatening emergency, where medical professionals are not readily available, in accordance with any applicable Department protocols and the following: (1) To the extent authorized by 105 CMR 700.003(D), the following persons may administer epinephrine or nerve agent antidotes (a) a first responder may administer epinephrine in accordance with 105 CMR 171.000: Massachusetts First Responder Training and the Statewide Treatment Protocols; (b) a public employee of or volunteer to a municipality or an agency, department or authority of the Commonwealth (“agency”), whose function includes emergency preparedness and response and who is designated by a municipality’s or agency’s medical director pursuant to 105 CMR 700.003(6)(b) (“authorized public employee”), may administer epinephrine as well as atropine, pralidoxime chloride and other nerve agent antidotes approved by the Department (“nerve agent antidotes”) to another authorized public employee; and (c) an authorized employee of or volunteer to a facility or program funded, operated or licensed by a municipality or agency may administer epinephrine to individuals served by such a program or facility (“program”);

2/1/13 105 CMR - 3983 The text of the regulations published in the electronic version of the Massachusetts Register is unofficial and for informational purposes only. The official version is the printed copy which is available from the State Bookstore at http://www.sec.state.ma.us/spr/sprcat/catidx.htm. 105 CMR: DEPARTMENT OF PUBLIC HEALTH

700.003: continued

(2) A municipality or agency may approve administration of epinephrine or nerve agent antidotes by authorized public employees, and a municipality or agency may approve administration of epinephrine by employees or volunteers of a program, provided that the municipality or agency registers with the Department in accordance with 105 CMR 700.004. This registration requirement shall not apply to: (a) a municipality or agency registered under 105 CMR 700.004(A)(2)(a) through (t); (b) a school district or non-public school subject to the provisions of 105 CMR 210.000: The Administration of Prescription Medications in Public and Private Schools; (3) Any administration is pursuant to the order of a practitioner, and, in the case of first responders, and the Statewide Treatment Protocols. (4) The epinephrine or nerve agent antidote is: (a) dispensed by a pharmacy pursuant to the order or prescription of a practitioner or other authorized prescriber; or (b) obtained by a municipality or agency in accordance with said entity’s registration. (5) The epinephrine or other antidote is packaged in a prefilled, automatic injection device intended for self-administration; (6) A qualified, licensed practitioner shall be designated by the registered municipality or agency as medical director for purposes of 105 CMR 700.003(D). Such person shall: (a) be the responsible person named on the registration of the municipality or agency; (b) authorize administration of epinephrine and nerve agent antidotes, as appropriate, and oversee compliance with 105 CMR 700.003(D); (c) establish and enforce written protocols and procedures to ensure that individuals administering epinephrine or nerve agent antidotes are properly trained, evaluated for competence, and up to date in their skills and knowledge. Training shall include, but not be limited to: 1. procedures for risk reduction; 2. recognition of the symptoms of a severe allergic or nerve agent reaction; 3. proper use of an auto-injector; 4. procedures for notification of emergency medical services and other appropriate persons following administration; (d) establish and enforce written protocols and procedures to ensure: 1. proper storage, handling and return or disposal of epinephrine or nerve agent antidote; 2. review and evaluation of an emergency response; 3. reporting of adverse events to the medical director; 4. monitoring of program compliance with 105 CMR 700.003(D); and (e) establish and enforce written protocols and procedures to ensure that a registered municipality or agency, or a program if authorized to administer epinephrine by a municipality or agency, maintains current and readily retrievable records of: 1. the authorized public employees or volunteers who may administer epinephrine and nerve agent antidotes or authorized program employees or volunteers who may administer epinephrine; 2. individual trainings and evaluations; 3. receipt and any return or disposal of epinephrine or nerve agent antidotes; and 4. administration of epinephrine or nerve agent antidote; (7) Each program authorized by a registered municipality or agency to administer epinephrine pursuant to 105 CMR 700.003(D) shall: (a) comply with the policies and procedures established pursuant to 105 CMR 700.003(D) by the registered municipality or agency; (b) designate a licensed health care practitioner, whenever possible, or the program director or designee, to oversee the program’s implementation of said policies and procedures; (c) in the case of minors served by the program, obtain prior informed consent whenever possible from the minor’s parent or legal guardian for the administration of epinephrine; (d) develop individualized medication administration plans that address indications for administration of epinephrine, any unique issues around storage or handling of the epinephrine and persons to be notified in the event that epinephrine is administered; and

9/2/11 105 CMR - 3984 The text of the regulations published in the electronic version of the Massachusetts Register is unofficial and for informational purposes only. The official version is the printed copy which is available from the State Bookstore at http://www.sec.state.ma.us/spr/sprcat/catidx.htm. 105 CMR: DEPARTMENT OF PUBLIC HEALTH

700.003: continued

(e) immediately notify emergency medical services and designated contact persons, including those identified in the medication plan, in the event that epinephrine is administered; and (8) The registered municipality or agency, and the Department of Public Health, shall have full access to all pertinent records for monitoring purposes.

(E) A school district or private school may register solely for the purpose of permitting trained school personnel to administer controlled substances in accordance with 105 CMR 210.000: The Administration of Prescription Medications in Public and Private Schools.

(F) An employee of a community program may administer or assist in the administration of a controlled substance or other prescription medication (prescription drug) to a non-self- administering person, provided that: (1) Registration. The community program is registered with the department in accordance with 105 CMR 700.004, and meets the following requirements: (a) Administration or assistance in the administration of prescription medication to a non-self-administering individual shall be carried out only by a duly licensed professional staff or by an unlicensed program staff of a registered community program who has successfully completed the training specified in 105 CMR 700.003(F)(2); (b) The program shall establish, maintain, and operate in accordance with policies that ensure that only properly trained and certified personnel administer medication; (c) The program shall maintain a current written listing of those staff members who have successfully completed a training program meeting the requirements of 105 CMR 700.003(F)(2); (d) The Department of Public Health shall be permitted by the program to inspect program and individuals' records pertaining to the use and administration of prescription medications and is permitted announced or unannounced on-site visits or inspections of common areas and such other inspections as the Department of Public Health is authorized to make in order to monitor the program's compliance with 105 CMR 700.000. (e) The Drug Control Program within the Department of Public Health shall promptly be notified by the program of any suspected shortages or diversion of prescription medication; (f) The program shall document in the individual's record any administration of prescription medication in a manner inconsistent with the practitioner's prescription or order or in violation of 105 CMR 700.000. The program shall also promptly report to the Department of Mental Health, Department of Developmental Services, or Department of Children and Families, in accordance with procedures and on a form approved jointly by the Department of Public Health and said Departments, any administration of prescription medication in a manner inconsistent with the practitioner's prescription or in violation of 105 CMR 700.000. Such form shall be provided, upon request, to the Department of Public Health; (g) The program shall provide or arrange for technical assistance and advice to be provided as needed by a Registered Nurse, Registered Pharmacist, or other Licensed Practitioner when questions arise regarding appropriate administration practices or the effects of medications. The program shall establish policies and procedures that ensure reasonable access to such assistance and advice; (h) The program, professional staff and program staff shall comply with all applicable requirements of M.G.L. c. 94C, the Controlled Substances Act, as well as 105 CMR 700.000 and all pertinent regulations of the Department of Mental Health, Department of Developmental Services, or Department of Children and Families, as appropriate, including those pertaining to storage, labeling, administration and documentation of prescription medication, medical back-up, review of medication, and emergency procedures. (2) Training. No unlicensed staff person may administer or assist in the administration of a prescription medication without successfully completing a training program that meets the specifications for a training curriculum and examination process established jointly by the Department of Public Health and the Department of Mental Health, Department of Developmental Services, or Department of Children and Families, as well as the following requirements:

2/1/13 105 CMR - 3985 The text of the regulations published in the electronic version of the Massachusetts Register is unofficial and for informational purposes only. The official version is the printed copy which is available from the State Bookstore at http://www.sec.state.ma.us/spr/sprcat/catidx.htm. 105 CMR: DEPARTMENT OF PUBLIC HEALTH

700.003: continued

(a) The training program shall be taught by a registered nurse, nurse practitioner, physician assistant, pharmacist, or physician who meets applicable requirements for a trainer established jointly by the Department of Public Health and the Department of Mental Health, Department of Developmental Services, or Department of Children and Families; (b) The Department of Public Health and, as appropriate, the Department of Mental Health, Department of Developmental Services, and Department of Children and Families shall have the authority to monitor the training program for compliance with established standards; (c) The training program shall keep records of all persons who have successfully completed the training program which shall be made available to the Department of Public Health and, as appropriate, to the Department of Mental Health, Department of Developmental Services, or Department of Children and Families upon request; (d) Each person who successfully completes the training program shall be certified by the Department of Mental Health, Department of Developmental Services, and Department of Children and Families, and shall be provided with such documentation of completion of the training program as approved by the Department of Mental Health, Department of Developmental Services, and Department of Children and Families. Documentation of certification shall be provided to and maintained by the program; (e) No person may continue to administer or assist in the administration of prescription medication beyond two years from the completion of the initial certification unless such person has met standards for retraining and/or retesting established by the Department of Mental Health, Department of Developmental Services, and Department of Children and Families and approved by the Department of Public Health. (3) Storage. The program meets all applicable regulations of the Department of Mental Health, Department of Developmental Services, or Department of Children and Families, as appropriate, and Department of Public Health regarding storage and handling of prescription medications as well as the following requirements: (a) All prescription medications that are consumed by individulas who are non-self- administering shall be appropriately secured in a locked container or area. The program shall have a written policy on which persons may have access to such container or area, how access to the key or combination and container or area is to be restricted, and under what conditions authorized persons may have access to the container or area; (b) Prescription medications for individuals who are self-administering shall be stored in a locked container or area unless the program director makes a determination that unlocked storage of the prescription medication poses no threat to the health or safety of the individual or other individuals; provided, however, that all controlled substances in Schedules II through V shall be appropriately secured in a locked container or area; (c) Outdated prescription medications and prescription medications that have not been administered due to a change in the prescription or a stop order shall be disposed of and the disposal documented in accordance with policies established by the program, provided that disposal occurs in the presence of at least two witnesses and in accordance with any policies of the Department of Public Health: (4) Labeling. All medications are properly labeled in accordance with M.G.L. c. 94C, § 21 and the following requirements: (a) Program staff shall not repack or relabel prescription medications that are taken or applied at any location or program regularly or frequently attended by the individual. All such prescription medications shall be packed and labeled by a pharmacist or, in the case of prescription medication dispensed for immediate treatment, by the dispensing practitioner; (b) Where prescription medication is consumed by an individual at two or more locations on a regular or frequent basis, the prescription medication shall be stored in a separate, properly packaged, labeled, and appropriately secured medication container at each location. In circumstances in which this is not practical or feasible, the Department of Mental Health, Department of Developmental Services, or Department of Children and Families shall establish an alternative procedure approved by the Department of Public Health. (c) The program shall have policies for obtaining a properly labeled container where there is a change in prescription or where the individual frequently or regularly receives prescription medication in two or more locations.

2/1/13 105 CMR - 3986 The text of the regulations published in the electronic version of the Massachusetts Register is unofficial and for informational purposes only. The official version is the printed copy which is available from the State Bookstore at http://www.sec.state.ma.us/spr/sprcat/catidx.htm. 105 CMR: DEPARTMENT OF PUBLIC HEALTH

700.003: continued

(5) Administration. All prescription medications are administered in accordance with M.G.L. c. 94C, regulations for the Department of Mental Health in 104 CMR 28.06: Medication, Department of Developmental Services in 115 CMR 5.15: Medication, or Department of Children and Families in 110 CMR 11.00: Medical Authorizations, and the following requirements: (a) All prescription medications shall be administered in accordance with the prescription of a practitioner; (b) Prescribed medications shall only be administered to or taken by the individual for whom the prescription has been written; (c) The program shall have a policy that specifies the administrative procedures to be followed when there is a medical emergency relating to medication. Such policy shall include a list of staff persons and medical personnel to be contacted which is up to date, readily available to staff and clearly indicates who is to be contacted on a 24 hour a day, seven day a week basis. The medical personnel to be contacted shall include the prescribing practitioner or, if unavailable, another licensed practitioner or appropriate emergency room personnel; (d) Certified staff employed by programs registered with the Department may only administer prescription medications that are oral, topical, ophthalmic, otic, internasal, suppository, or products that are administered by inhalation; (e) Parenteral drugs generally intended for self administration, or drugs administered via a gastrostomy/jejunostomy tube may be administered by certified staff members who have successfully completed a specialized training program in such technique taught by a physician, physician assistant, pharmacist, registered nurse, or nurse practitioner, approved by the Department of Public Health and the Department of Mental Health, Department of Developmental Services, or Department of Children and Families. Such technique shall be used only with the written authorization and in accordance with the written instructions of the prescribing physician; (f) Whenever possible, a prescription for medication shall be limited to a 37-day supply and one refill. The prescribing practitioner shall be notified by program staff of this requirement; (g) Where an individual who is non-self-administering receives prescription medication at a location other than a program site covered by 105 CMR 700.000 (off-site), the program whenever possible shall identify program staff responsible for administering the medication and make available to that person instructions as to how the medication is to be administered; (h) An over-the-counter drug may be consumed or applied by a non-self administering individual who is already receiving prescription medication only: 1. with the prior approval of a practitioner; or 2. after consultation with a pharmacist or registered nurse; or 3. in accordance with applicable guidelines established by the Department of Mental Health, Department of Developmental Services, or Department of Children and Families, with the approval of the Department of Public Health. (6) Documentation. All prescriptions and administration of prescription medications shall be documented in accordance with applicable regulations of the Department of Mental Health, Department of Developmental Services, or Department of Children and Families and the following requirements: (a) All prescriptions for medication shall be documented in the individual's record. Such documentation shall specify for each individual the name and dosage of medication, the indication for which the medication is prescribed, and contraindications or possible allergic reactions, possible side effects and appropriate staff response, and special instructions, including steps to be taken if a dose is missed. The program shall establish appropriate policy and procedures to address how program staff shall obtain relevant prescription information in accordance with the requirements of 105 CMR 700.003(F)(6). In addition, such policy and procedures shall ensure that telephone medication orders and medication changes are received from licensed practitioners and properly documented in the individual's record; (b) The program shall ensure that staff have ready access to such information as listed in 105 CMR 700.003(F)(6)(a), by maintaining on site either an appropriate reference approved by the Department of Public Health or, for each drug administered, a copy of the pertinent section of such reference or a medication-specific drug information sheet that states in plain language generally why the drug is used, when it is to be administered, how it should be administered, any special instructions or precautions, proper storage conditions, possible side effects and what is to be done if a dose is missed;

2/1/13 105 CMR - 3987 The text of the regulations published in the electronic version of the Massachusetts Register is unofficial and for informational purposes only. The official version is the printed copy which is available from the State Bookstore at http://www.sec.state.ma.us/spr/sprcat/catidx.htm. 105 CMR: DEPARTMENT OF PUBLIC HEALTH

700.003: continued

(c) The taking or applying of medications for non-self-administering individuals, including over-the-counter drugs, shall be documented in the individual's record; 1. the time that the medication is taken or applied shall be noted in the record; 2. the record shall indicate any off-site taking or applying of medication by a non-self-administering individual that would normally occur at the program site; 3. individuals who are self-administering shall not be required to document their own self-administration of medication; (d) Any change in medications or dosage levels of a medication shall be treated as a new medication order for the purposes of documentation; (e) A non-self-administering individual's residential program shall notify the individual's day program of any prescription medications that the individual is taking and shall provide the program with a copy of the medication order for each prescription medication that the individual receives. Where a non-self-administering individual receives prescription medication solely at the day program, the day program shall have responsibility for notifying the residential program and providing it with a copy of the medication order; (f) The program shall establish procedures to document the date that any individual's prescription is filled and the quantity of medication dispensed by the pharmacy; (g) Except for persons who are self-administering, the program shall maintain a documented accounting of the quantities of all controlled substances in Schedules II through V, stored by the program, which shall be reconciled at the end of each shift or as otherwise approved by the Department.

(G) Optometrists may utilize and issue written prescriptions and medication orders, in accordance with the provisions of M.G.L. c. 112, §§ 66 and 66B, for those topical pharmaceutical agents in Schedule VI required for the diagnosis, prevention, management or treatment of abnormal ocular conditions or diseases as defined in M.G.L. c. 112, § 66, except glaucoma.

(H) Notwithstanding any other Department regulation, a health care professional duly licensed or certified by the Department, or a medical or nursing student duly enrolled in an approved or accredited program for licensure and acting in accordance with the policies of that program, may possess and administer vaccine for the prevention of a pandemic, novel or seasonal influenza virus, provided the Commissioner determines that there are or will be insufficient health care professionals available for timely vaccine administration and issues an order authorizing such administration. (1) To the extent authorized by 105 CMR 700.003(H), a health care professional duly licensed or certified by the Department, or a medical or nursing student duly enrolled in an approved or accredited program for licensure and acting in accordance with the policies of that program, may administer vaccine if: (a) authorized to administer vaccine by order of the Commissioner; (b) administration is in accordance with the Commissioner's order and the order or prescription of a duly registered practitioner authorized to issue an order or prescription for a vaccine pursuant to 105 CMR 700.000; and (c) with respect to a student administering vaccine pursuant to 105 CMR 700.003(H), authorized and supervised by a licensed and qualified health care professional. (2) In accordance with the Commissioner's order, a person administering vaccine shall: (a) receive proper training and supervision in the administration of the vaccine; (b) comply with written protocols to ensure proper storage, handling and return of vaccine, record keeping regarding administration, response to adverse events, and safe and appropriate administration of vaccine.

(I) A pharmacist may issue, modify or discontinue a written prescription, oral prescription or medication order as authorized in a collaborative practice agreement meeting the requirements of 247 CMR 16.00: Collaborative Drug Therapy Management, 243 CMR 2.12: Collaborative Drug Therapy Management (CDTM) with Authorized Pharmacies and M.G.L. c. 112, § 24B½, provided the following requirements are met: (1) the pharmacist meets all applicable requirements of the Board of Registration in Pharmacy established in accordance with M.G.L. c. 112, § 24 and 247 CMR 1.00 through 16.00;

2/1/13 105 CMR - 3988 The text of the regulations published in the electronic version of the Massachusetts Register is unofficial and for informational purposes only. The official version is the printed copy which is available from the State Bookstore at http://www.sec.state.ma.us/spr/sprcat/catidx.htm. 105 CMR: DEPARTMENT OF PUBLIC HEALTH

700.004: continued

2. epinephrine, atropine, pralidoxime chloride and other nerve agent antidotes approved by the Department for use by public employees and volunteers whose functions include emergency preparedness and response, including first responders. (k) A pharmacist is registered for the purpose of issuing, modifying or discontinuing a written prescription, oral prescription or medication order in accordance with requirements for collaborative drug therapy management specified in 247 CMR 16.00: Collaborative Drug Therapy Management, 243 CMR 2.12: Collaborative Drug Therapy Management (CDTM) with Authorized Pharmacies and M.G.L. c. 112, § 24B½. (l) A nurse practitioner, psychiatric nurse, nurse anesthetist or physician assistant, authorized and registered by the appropriate board of registration is deemed to be registered to dispense controlled substances in accordance with written guidelines mutually developed and agreed upon with a supervising physician. (m) A nurse midwife, authorized and registered by the Board of Registration in Nursing (244 CMR), is deemed to be registered to dispense controlled substances. (n) A registered optometrist registered by the Board of Registration in Optometry may utilize and issue written prescriptions and medication orders, in accordance with the provisions of M.G.L. c. 112, §§ 66 and 66B, for those topical pharmaceutical agents in Schedule VI required for the diagnosis, prevention, management or treatment of abnormal ocular conditions or diseases as defined in M.G.L. c. 112, § 66, except glaucoma. (2) No person shall engage in any activities involving any controlled substance in any schedule for which he is not registered.

(D) Automatic Registrations. The Commissioner shall automatically issue a registration to dispense controlled substances other than for research pursuant to M.G.L. c. 94C, § 8, to any physician, dentist, podiatrist, or veterinarian who is duly authorized to practice his or her profession in the Commonwealth, provided that, any such physician, dentist, podiatrist, or veterinarian shall only be registered for Massachusetts Schedule VI and for the same schedules as he or she is registered with the Drug Enforcement Administration. (1) Any physician, dentist, podiatrist or veterinarian who is not registered with the Drug Enforcement Administration shall be automatically registered to dispense controlled substances but only for Massachusetts Schedule VI. (2) The Commissioner may periodically recall registrations to dispense controlled substances issued to practitioners, in accordance with M.G.L. c. 94C, § 7(f), and may issue a new registration upon verification that the practitioner continues to be duly authorized to practice his or her profession in Massachusetts.

(E) Time for Application and Term of Registration. No person required to be registered shall engage in any activity for which registration is required until he or she is registered for that activity. (1) Any person who is registered with the Commissioner may apply to be re-registered on a form provided by the Commissioner not more than 60 days before the expiration date of his or her registration. (2) Any registration issued by the Commissioner other than a registration to conduct research activities with Schedule I controlled substances or a registration to dispense automatically issued shall be effective for one year from the date of issuance. (3) A registration issued to conduct research with Schedule I controlled substances shall be for such period, not to exceed one year, as may be specified by the Commissioner. (4) Any person who is registered may at any time apply for a modification of his or her registration on a form supplied by the Commissioner.

(F) Separate Registrations Required for Separate Locations. A separate registration is required at each principal place of business or professional practice at one general physical location where the applicant or registrant manufactures, distributes or dispenses controlled substances, or uses controlled substances in research, teaching, or chemical analysis. (1) The following locations are deemed not to be places where controlled substances are manufactured, distributed, or dispensed: (a) A warehouse where controlled substances are stored by or on behalf of a registered person, unless such substances are distributed directly from such warehouse to registered locations other than the registered location from which the substances were delivered.

2/1/13 105 CMR - 3993 The text of the regulations published in the electronic version of the Massachusetts Register is unofficial and for informational purposes only. The official version is the printed copy which is available from the State Bookstore at http://www.sec.state.ma.us/spr/sprcat/catidx.htm. 105 CMR: DEPARTMENT OF PUBLIC HEALTH

700.004: continued

(b) An office used by an agent of a registrant where sales of controlled substances are solicited, made or supervised but which neither contains such substances, nor serves as a distribution point for filling sales orders. (c) An office or registered hospital or other registered health facility which is used by a registered individual practitioner, pharmacist or optometrist who is registered at another location which is his principal place of professional practice, provided that no controlled substances are maintained by such practitioner at any place where he or she is not registered.

(G) Limitations on Registration for Schedule I. No person other than a person proposing to manufacture controlled substances in Schedule I; or a person proposing to conduct research on human beings involving controlled substances in Schedule I pursuant to M.G.L. c. 94C, § 8; or a person proposing to engage in qualitative or quantitative analysis of those controlled substances in Schedule I within a scientific laboratory shall be registered for activities involving the manufacture, distribution or dispensing of Schedule I controlled substances unless expressly authorized so to do by the Commissioner: (1) Every applicant for registration for activities involving the manufacture, distribution or dispensing of controlled substances in Schedule I shall demonstrate to the satisfaction of the Commissioner, unless waived by the Commissioner: (a) That he or she is registered by the Drug Enforcement Administration specifically to manufacture, or conduct research involving, or to conduct chemical analysis with, controlled substances in Schedule I, and (b) That he or she has never had an application denied or suspended or revoked by the Drug Enforcement Administration or any predecessor agency for violation of any law or regulation and (c) That his or her physical security controls are specifically approved by the Drug Enforcement Administration, and (d) That in the case of an application to conduct research with controlled substances in Schedule I his or her protocol is attached to his or her application and satisfies the requirements of 105 CMR 700.009(H).

(H) Content and Form of Application. Each application for registration, renewal of a registration, or modification of a registration shall be on a form provided or approved by the Commissioner. (1) The application form shall include: (a) The applicant's name; (b) The name and title of a responsible authorized representative of the applicant if the applicant is an institution, corporation, or other entity; (c) The applicant's principal place of carrying on his or her or its business or profession; (d) The applicant's business or professional activity for which he or she proposes to be registered; (e) The schedules for which the applicant wishes to be registered; and (f) The applicant's Drug Enforcement Administration registration number, if any. (g) The application of a nurse practitioner, psychiatric nurse, nurse anesthetist, physician assistant or pharmacist shall include the name and address of a supervising physician, a general description of the supervising physician's scope of practice, and the signature of the supervising physician. The nurse practitioner, psychiatric nurse, nurse anesthetist, physician assistant or pharmacist shall promptly notify the Department of any termination of employment, change of address, or change of supervising physician. (2) The Commissioner may, in his or her judgment, require additional information.

(I) Application to Manufacture a New Controlled Substance. Any person who proposes to manufacture a controlled substance for which he or she is not registered with the Drug Enforcement Administration, shall file with the Commissioner a copy of DEA Form 130, which shall be treated as confidential by said Commissioner. (1) He or she shall file a copy thereof at the time he or she files such form with the Drug Enforcement Administration or before he or she begins manufacture, whichever is earlier. (2) The applicant need not disclose any technical detail of the process which he or she regards as a trade secret but he must identify each substance used in or resulting from successive stages of manufacture, in order to notify the Commissioner of precursors and byproducts.

2/1/13 105 CMR - 3994 The text of the regulations published in the electronic version of the Massachusetts Register is unofficial and for informational purposes only. The official version is the printed copy which is available from the State Bookstore at http://www.sec.state.ma.us/spr/sprcat/catidx.htm. 105 CMR: DEPARTMENT OF PUBLIC HEALTH

700.010: continued

(B) All sample medications dispensed by a registered individual practitioner shall be properly labeled. (1) Whenever a sample medication is dispensed by a registered individual practitioner, a label shall be affixed to the outside of the package, and shall include the following information: (a) a registered individual practitioner's name and address; (b) date of dispensing; and (c) name of the patient, unless a veterinary product. (2) In addition, the following information must be included on the label unless already provided for on the manufacturer's packaging of the sample medication: (a) name, dosage form and strength of the sample medication; (b) clear, simple and brief directions for use and any necessary cautionary statements; and (c) date on which the medication will expire. (3) Information provided to the patient under 105 CMR 700.010(B)(2) shall be, in the professional judgement of the registered individual practitioner, presented in a manner which can be easily understood by the patient. A combination of written information, labeling and counseling may be used to meet this requirement, based upon the individual needs of each patient. (4) If multiple packages of the same sample medication are dispensed at the same time to the same patient, the samples may be placed in a larger container to which the label containing applicable information required by 105 CMR 700.010 has been affixed.

700.011: Issuance of Prescriptions or Medication Orders for Implantable Infusion Pumps Containing Schedule II or Schedule III Controlled Substance

A prescription or medication order for an implantable infusion pump containing a Schedule II or Schedule III controlled substance may be filled for a maximum of a 90 day supply.

700.012: Prescription Monitoring Program

(A) Pharmacy Reporting Requirements. (1) The reporting requirement of 105 CMR 700.012 shall apply to every pharmacy in a health facility registered with the Commissioner that dispenses a controlled substance pursuant to a prescription in Schedules II through V, or a controlled substance classified by the Department as an additional drug, and to any pharmacy in another state, commonwealth, district or territory that delivers such a controlled substance to a person in Massachusetts. Such a pharmacy shall, in accordance with standards established by the Commissioner or designee, transmit to the Department or its agent the following information for each such prescription: (a) pharmacy identifier; (b) prescription number; (c) customer identifier, as defined in 105 CMR 700.001; (d) relationship of customer to patient; (e) patient name; (f) patient address; (g) patient date of birth; (h) patient gender; (i) source of payment for prescription; (j) date prescription written by prescriber; (k) date the controlled substance is dispensed; (l) identifier of controlled substance dispensed; (m) metric quantity of controlled substance dispensed; (n) estimated days supply of controlled substance dispensed; (o) refill information; and (p) prescriber identifier. (2) 105 CMR 700.012 shall not apply to the dispensing pursuant to a medication order of a controlled substance to an inpatient in a hospital.

2/1/13 105 CMR - 4002.1 The text of the regulations published in the electronic version of the Massachusetts Register is unofficial and for informational purposes only. The official version is the printed copy which is available from the State Bookstore at http://www.sec.state.ma.us/spr/sprcat/catidx.htm. 105 CMR: DEPARTMENT OF PUBLIC HEALTH

700.012: continued

(3) A pharmacy that dispenses a controlled substance subject to the requirements in 105 CMR 700.012 must report the customer identifier required by 105 CMR 701.004. A pharmacy may dispense a controlled substance without a customer identifier, provided it meets the requirements of 105 CMR 701.004(B) and provides to the Department those informational fields required by the Department. (4) The Commissioner or designee may waive or modify the requirement in 105 CMR 700.012(A)(1)(c) and/or (d), for a pharmacy to report a customer identifier and/or the relationship of the customer to the patient, for prescription refills, prescription deliveries and/or other activities/situations specified by the Commissioner or designee. (5) The information required by 105 CMR 700.012 shall be transmitted to the Department or its agent in accordance with any procedures established by the Commissioner or designee at least once every seven days and no later than ten days after dispensing, or as otherwise specified in guidelines of the Department, by use of encrypted electronic device or electronic transmission method in a format approved by the Commissioner or designee. (6) If a pharmacy is not able to submit dispensing information by electronic means, the Commissioner or designee may issue a waiver to authorize another means of transmission, provided that all information required in accordance with 105 CMR 700.012(A) is submitted in this alternate format.

(B) Prescription Monitoring Program Advisory Council. (1) The Commissioner of the Department of Public Health may establish a Prescription Monitoring Program Advisory Council to advise the Department on the implementation of 105 CMR 700.012. The membership of the Advisory Council may include, but need not be limited to, representatives of the Department of Public Health; Executive Office of Health and Human Services; Executive Office of Public Safety; Boards of Registration responsible for licensing professionals authorized to prescribe or dispense controlled substances, including the Boards of Registration in Medicine, Pharmacy, Dentistry, Podiatry, Veterinary Medicine, Optometry, Nursing and Physician Assistants; representatives of associations or societies representing professions authorized to prescribe or dispense controlled substances, patient interests, privacy interests; and a person with expertise in the design or operation of a secure automated data system. (2) The Prescription Monitoring Program Advisory Council may assist the Department and Boards of Registration, as appropriate, in designing education programs for the appropriate use of prescription monitoring program information.

(C) Prescription Monitoring Program Medical Review Group. (1) The Commissioner may establish the Prescription Monitoring Program Medical Review Group to advise the Department on accepted medical practice standards related to the disclosure of information pursuant to subsection 105 CMR 700.012(D)(4)(b). The Medical Review Group shall advise the Department in the evaluation of prescription information and clinical aspects of the implementation of 105 CMR 700.012. (2) Members of the Medical Review Group shall be licensed health care practitioners and pharmacists and, to the extent feasible, at least one member shall be licensed in the same discipline as the practitioner whose records are under review. Practitioners serving on the Medical Review Group must have a valid Controlled Substances Registration for Schedules II through VI pursuant to M.G.L. c. 94C, § 7.

(D) Privacy, Confidentiality and Disclosure. (1) Except where otherwise provided by judicial order, statute or regulation, including but not limited to 105 CMR 700.012(D)(2), the information collected pursuant to 105 CMR 700.012 shall be kept confidential by the Department. (2) The Department shall, upon request and to the extent made feasible by 105 CMR 700.012(F), provide data collected pursuant to 105 CMR 700.012 to: (a) an individual authorized and registered to prescribe or dispense controlled substances, for the purpose of providing medical or pharmaceutical care to a patient; (b) a person authorized to act on behalf of an entity designated by M.G.L. c. 94C, § 24A, provided the request is in connection with a bona fide specific controlled substance or additional drug-related investigation, and further provided that such entity is:

2/1/13 105 CMR - 4002.2 The text of the regulations published in the electronic version of the Massachusetts Register is unofficial and for informational purposes only. The official version is the printed copy which is available from the State Bookstore at http://www.sec.state.ma.us/spr/sprcat/catidx.htm. 105 CMR: DEPARTMENT OF PUBLIC HEALTH

700.012: continued

1. a state board or regulatory agency that supervises or regulates a profession that may prescribe or dispense controlled substances; 2. a local, state or federal law enforcement agency or prosecutorial office working with the Executive Office of Public Safety engaged in the administration, investigation or enforcement of criminal law governing controlled substances; 3. the Executive Office of Health and Human Services, acting with regard to a MassHealth program recipient; 4. the United States Attorney; 5. the Office of the Attorney General; or 6. the office of a District Attorney. (c) a duly authorized representative of a health department or other agency in another state, commonwealth, district, territory or country that maintains prescription information in a data system with privacy, security and other disclosure requirements consistent with those established in the Commonwealth, in accordance with a valid, written reciprocal data sharing agreement establishing the terms and conditions for exchange of data; and (d) an individual or the individual's parent or legal guardian, who requests the individual's own prescription monitoring information in accordance with procedures established under M.G.L. c. 66A and other applicable statute or regulation of the Commonwealth. (3) A request for information collected pursuant to 105 CMR 700.012 shall be in writing or, if applicable, transmitted electronically pursuant to 105 CMR 700.012(F) and shall be made in accordance with procedures established by the Commissioner or designee to ensure compliance with the requirements of 105 CMR 700.012(D) and (E). (4) The Commissioner or designee may initiate disclosure of data on a patient or research subject collected pursuant to 105 CMR 700.012 to an individual authorized and registered to prescribe or dispense controlled substances in any or all of the Schedules II through V, and Schedule VI if applicable, pursuant to 105 CMR 700.000, provided that: (a) The authorized individual has prescribed or dispensed such a controlled substance to the patient or research subject; (b) The Commissioner or designee has determined that the patient or research subject is receiving a controlled substance or additional drug from more than one source and in quantities that he determines to be harmful to the health of the patient or research subject or that disclosure is otherwise necessary to prevent the unlawful diversion of a controlled substance; and (c) Such disclosure shall not require or direct the authorized individual to take action that he or she believes to be contrary to the patient's or research subject's best interests. (5) (a) The Department shall review the prescription monitoring information collected pursuant to 105 CMR 700.012. If there is reasonable cause to believe a violation of law or breach of professional standards may have occurred, the Department shall notify the appropriate law enforcement or professional licensing, certification or regulatory agency or entity and provide prescription monitoring information required for an investigation. (b) Disclosure at the initiation of the Commissioner or designee pursuant to 105 CMR 700.012(D)(4) and (5) shall be in conformance with any protocols established by the Commissioner or designee, who may consult with the Medical Review Group. When such consultation is provided on Commissioner initiated disclosure, the Medical Review Group shall review the content and application of the protocols, make recommendations to the Commissioner for effective use of such protocols and as needed review specific instances of Commissioner initiated disclosure. If undertaking such review, the Medical Review Group may be provided upon request with such pertinent information as needed. (6) The Commissioner or designee may provide de-identified, aggregate data to a public or private entity for statistical research or educational purposes. (7) Data collected pursuant to 105 CMR 700.012(A) shall not be a public record and shall not be disclosed to anyone other than those persons specifically authorized under 105 CMR 700.012(D).

2/1/13 105 CMR - 4002.3 The text of the regulations published in the electronic version of the Massachusetts Register is unofficial and for informational purposes only. The official version is the printed copy which is available from the State Bookstore at http://www.sec.state.ma.us/spr/sprcat/catidx.htm. 105 CMR: DEPARTMENT OF PUBLIC HEALTH

700.012: continued

(E) Security Protections. (1) Any disclosure or transmission of personally identifying information collected pursuant to 105 CMR 700.012 shall be in accordance with Department security requirements for such disclosure and transmission, including requirements for technical non-repudiation, confidentiality, and authentication, as those terms are defined in 105 CMR 721.000. Such protections shall include the establishment of a record of each request and transmission. (2) A person authorized to receive information pursuant to 105 CMR 700.012(D) shall promptly notify the Department of any potential violation of confidentiality or use of the data in a manner contrary to 105 CMR 700.012 or applicable professional standards. (3) A person's Controlled Substance Registration may be suspended or terminated in accordance with 105 CMR 700.004(L)(1) for the following: (a) a request for data pursuant to 105 CMR 700.012(D), or use or disclosure of data that involves a willful failure to comply with the standards in 105 CMR 700.012 for request, transmission or disclosure of data; (b) a failure to reasonably protect data in accordance with the requirements of 105 CMR 700.012 or other applicable state or federal law; or (c) an attempt to obtain data through fraud or deceit.

(F) Electronic Transmission of Prescription Monitoring Program Information. (1) The Department may establish means for secure electronic transmission of prescription monitoring program information to facilitate disclosure of such information authorized pursuant to 105 CMR 700.012. (2) The Department may allow an authorized individual listed in 105 CMR 700.012(D)(2)(a) through (c), or a designee of such individual as approved by the Commissioner or designee, to use the secure electronic transmission system established pursuant to 105 CMR 700.012(F)(1) in accordance with security protocols established by the Commissioner or designee. (3) Use of the secure electronic transmission system shall be limited to the uses authorized by 105 CMR 700.012. (4) An authorized end user of the secure electronic transmission system must agree and attest to terms and conditions of use established by the Commissioner or designee. (5) Failure of an end user to comply with 105 CMR 700.012 may result in revocation of the end user's authorization to use the secure electronic transmission system and may subject the end user to further sanction pursuant to 105 CMR 700.012(E)(3) or other state law.

700.020: Severability

The provisions of 105 CMR 700.000 are severable, and if any provision shall be in violation of any Federal rule or regulation or any Federal or Massachusetts law, such provision shall be null and void and such violation shall not affect or impair any of the remaining provisions.

REGULATORY AUTHORITY

105 CMR 700.000: M.G.L. c. 94C, §§ 2, 6, 24 and 24A.

2/1/13 105 CMR - 4002.4 The text of the regulations published in the electronic version of the Massachusetts Register is unofficial and for informational purposes only. The official version is the printed copy which is available from the State Bookstore at http://www.sec.state.ma.us/spr/sprcat/catidx.htm. Docket # 1,122

THE COMMONWEALTH OF MASSACHUSETTS William Francis Galvin Secretary of the Commonwealth

Regulation Filing To be completed by filing agency

CHAPTER NUMBER: 105 CMR 701.000

CHAPTER TITLE: Regulations Adopted Jointly by Dept. of Public Health & Bd. of Reg. in Pharmacy to Implement M.G.L. c. 94C AGENCY: Department of Public Health

SUMMARY OF REGULATION: State the general requirements and purposes of this regulation. This regulation establishes rules for dispensing of certain drug products. The amendments update the language to be consistent with language in 105 CMR 700.000.

REGULATORY AUTHORITY: M.G.L. c. 94C, s. 4

AGENCY CONTACT: Alison J. Mehlman PHONE: 617-624-5232

ADDRESS: 250 Washington St., Boston, MA 02108

Compliance with M.G.L. c. 30A

EMERGENCY ADOPTION - if this regulation is adopted as an emergency, state the nature of the emergency.

PRIOR NOTIFICATION AND/OR APPROVAL - If prior notification to and/or approval of the Governor, Legislature or others was required, list each notification, and/or approval and date, including notice to the Local Government Advisory Commission. Massachusetts Municipal Association: 3/30/12 Executive Office of Communities and Development: 3/30/12

Date of public hearing or comment period: 7/20/12

For the first five years:

No fiscal effect: No fiscal effect on public or private sectors

Date amended small business impact statement was filed: 1/15/13

CODE OF MASSACHUSETTS REGULATIONS INDEX - List key subjects that are relevant to this regulation: Controlled Substances

ATTESTATION - The regulation described herein and attached hereto is a true copy of the regulation adopted by this agency. ATTEST:

SIGNATURE: SIGNATURE ON FILE DATE: Jan 17 2013

Publication - To be completed by the Regulations Division

MASSACHUSETTS REGISTER NUMBER: 1227 DATE: 02/01/2013

EFFECTIVE DATE: 02/01/2013

CODE OF MASSACHUSETTS REGULATIONS Remove these pages: Insert these pages: 4003, 4004 4003, 4004 4029, 4030 4029, 4030

01/17/2013 mrs

105 CMR 701.000: REGULATIONS ADOPTED JOINTLY BY THE DEPARTMENT OF PUBLIC HEALTH AND THE BOARD OF REGISTRATION IN PHARMACY FOR THE IMPLEMENTATION OF M.G.L. c. 94C

Section

701.001: Excluded Non-Narcotic Substances 701.002: Excepted Compounds 701.003: Emergency Situations in Which Controlled Substances in Schedule II May Be Dispensed upon Oral Prescription 701.004: Requirements for Positive Identification for Dispensing of a Controlled Substance in Schedule II through V

701.001: Excluded Non-Narcotic Substances

The following nonnarcotic substances which may, under the Federal Food, Drug, and Cosmetic Act be lawfully sold over the counter without a prescription, are excluded from all schedules.

Table 1.

Amodrine Tablet: Phenobarbital, 8mg.; G.D. Searle & Co. aminophylline, 100 mg.; racephedrine hydrochloride, 25 mg. Bronkaid Tablet: Phenobarbital, 8 mg.; Drew Pharmacal Co., Inc. ephedrine sulfate, 24 mg.; glyceryl guaiacolate, 100 mg.; theophylline, 100 mg.; thenyldiamine, 10 mg.

Bronkolixir Elixir (5cc); Phenobarbital, 4 Breon Laboratories, Inc. mg.; ephedrine sulfate, 12 mg.; glyceryl guaiacolate, 50 mg.; theophylline, 15 mg.; chlorpheniramine maleate, 1 mg.

Bronkotabs Tablet: Phenobarbital, 8 mg., Do. ephedrine sulfate, 24 mg.; glyceryl gualacolate, 100 mg.; theophyline, 100 mg.; thenyldiamine, 10 mg.

Primatene Tablet: Phenobarbital, c gr.; Whitehall Laboratories ephedrine d gr. Tedral Tablet: Phenobarbital, 8 mg.; Warner-Chilcott Laboratories theophylline, 130 mg.; ephedrine hydrochloride, 24 mg.

Tedral Anti-H Tablet: Phenobarbital, 8 mg. Do. chlorpheniramine maleate, 2 mg.; theophylline, 130 mg.; ephedrine hydrochloride, 24 mg.

2/1/13 105 CMR - 4003 The text of the regulations published in the electronic version of the Massachusetts Register is unofficial and for informational purposes only. The official version is the printed copy which is available from the State Bookstore at http://www.sec.state.ma.us/spr/sprcat/catidx.htm. 105 CMR: DEPARTMENT OF PUBLIC HEALTH

701.001: continued

Tedral ½ strength Tablet: Phenobarbital, 4 mg.; Do. theophylline, 65 mg.; ephedrine hydrochloride, 12 mg.

Tedral Pediatric Suspension Suspension (5cc); Do. Phenobarbital, 4 mg.; ephedrine hydrochloride, 12 mg.; theophylline, 65 mg.

Tedral suppositories double Suppository: Phenobarbital, 16 Do. strength mg.; theophylline 260 mg.; ephedrine hydrochloride, 48 mg. Tederal suppositories regular Suppository: Phenobarbital, 8 Do. strength mg.; theophylline, 130 mg.; ephedrine hydrochloride, 24 mg.

Verequad Tablet: Phenobarbital, 8 mg.; Knoll Pharmaceutical Co. theophylline calcium salicylate, 130 mg.; ephedrine hydrochloride, 24 mg.; glyceryl guaiacoate, 100 mg. Verequad Suspension (5cc): Do. Phenobarbital, 4 mg.; theophylline calcium salicylate, 65 mg.; ephedrine hydrochloride, 12 mg.; glyceryl guaiacolate, 50 mg.

701.002: Excepted Compounds

(A) The following drugs in dosage unit form, and any other drug of the quantitative composition shown below for one of the following drugs or which is the same except that it contains a lesser quantity of controlled substances or other substances which do not have a stimulant, depressant, or hallucinogenic effect, and which are restricted by law to dispensing on prescription, are excepted from all schedules except Schedule VI.

Trade name or other designation Composition Manufacturer or supplier

A.E.A. Tablet: Amobarbital, 25 mg.; Haack Laboratories, Inc. aminophylline, 120 mg.; ephedrine hydrochloride, 25 mg.

Alased Tablet: Phenobarbital, 16.2 Norgine Laboratories, Inc. mg.; homatropine methylbromide, 3.6 mg.; aluminum hydroxide gel, dried 7½ gr.: magnesium trisilicate, 2½ gr.

Alcitex Tablet: Phenobarbital, c gr.; Paul B. Elder Co., Inc. atropine sulfate, 1/300 gr.; calcium carbonate, 3cgr., magnesium carbonate, 2½ gr.; cerium oxalate, ½ gr.

4/1/94 105 CMR - 4004 The text of the regulations published in the electronic version of the Massachusetts Register is unofficial and for informational purposes only. The official version is the printed copy which is available from the State Bookstore at http://www.sec.state.ma.us/spr/sprcat/catidx.htm. 105 CMR: DEPARTMENT OF PUBLIC HEALTH

701.002: continued

(B) A controlled substance in Schedule V may be dispensed by a pharmacist without a prescription to a purchaser at retail provided that: (1) The compound, mixture or preparation containing the controlled substance is not a prescription drug and, (2) The compound, mixture, or preparation contains not more than 100 milligrams of opium per 100 milliliters or per 100 grams.

(C) Substances Excepted from Schedule V are subject to the following conditions: (1) That such preparation shall be dispensed or sold in good faith as a medicine and not for the purpose of evading the provisions of the controlled substance law; and (2) That the purchaser of such preparation identify himself to the satisfaction of the pharmacist; and (3) That no more than four ounces of such preparation are dispensed or sold to a person during any 48 hour period, and (4) That the pharmacist dispensing such excepted substances shall keep an accurate record book including the name and address of the purchaser, the name of the preparation, the strength per dosage unit, the quantity dispensed and the date.

701.003: Emergency Situations in Which Controlled Substances in Schedule II May Be Dispensed upon Oral Prescription

(A) "Emergency situations", for the purpose of permitting the dispensing of any controlled substance in Schedule II upon oral prescription, means those situations in which the practitioner who proposes to prescribe a controlled substance in Schedule II determines: (1) That the immediate administration of the controlled substance is necessary for proper treatment of the intended ultimate user, and (2) That no appropriate alternative treatment is available, including administration of a controlled substance which is not in Schedule II, and (3) That it is not reasonably possible for the practitioner to provide a written prescription to be presented to the person dispensing the controlled substance prior to the dispensing.

(B) In case of an emergency situation as defined above, a pharmacist may dispense a controlled substance in Schedule II upon receiving oral authorization of a prescribing individual practitioner; provided that: (1) The quantity prescribed and dispensed is limited to the amount adequate to treat the patient during the emergency period; and (2) The prescription is immediately reduced to writing by the pharmacist and contains all information required in M.G.L. c. 94C, § 20(a), except for the signature of the prescribing individual practitioner; and (3) If the prescribing individual practitioner is not known to the pharmacist, he makes reasonable good faith effort to determine that the oral authorization came from a registered individual practitioner, including a callback to the prescribing individual practitioner using his phone number listed in the telephone directory or other good faith efforts to insure his identity.

(C) Within 72 hours after authorizing an emergency oral prescription, the prescribing individual practitioner shall cause a written prescription for the emergency quantity prescribed to be delivered to the dispensing pharmacist. In addition to conforming to the requirements of M.G.L. c. 94C, § 20(a), the prescription shall have written on its face "Authorization for Emergency Dispensing". The written prescription may be delivered to the pharmacist in person or by mail, but if delivered by mail it must be postmarked within the 72-hour period.

4/1/94 105 CMR - 4029 The text of the regulations published in the electronic version of the Massachusetts Register is unofficial and for informational purposes only. The official version is the printed copy which is available from the State Bookstore at http://www.sec.state.ma.us/spr/sprcat/catidx.htm. 105 CMR: DEPARTMENT OF PUBLIC HEALTH

701.003: continued

(D) Upon receipt of the written prescription the dispensing pharmacist shall attach the prescription to the oral emergency prescription which had earlier been reduced to writing. The pharmacist shall notify the nearest office of the Bureau of Narcotics and Dangerous Drugs, U.S. Department of Justice and the Commissioner of Public Health if the prescribing individual practitioner fails to deliver a written prescription to him within seven days.

701.004: Requirements for Positive Identification for Dispensing of a Controlled Substance in Schedule II Through V

(A) A pharmacy shall require that a customer identifier, as defined in 105 CMR 700.001: Definitions, be presented by the ultimate user or agent of the ultimate user to whom a prescription for a controlled substance in Schedules II through V, or a controlled substance classified as an additional drug in accordance with 105 CMR 700.012(A)(1), is dispensed.

(B) The pharmacy may dispense a controlled substance in Schedules II through V or an additional drug without meeting the requirement in 105 CMR 701.004(A), provided that: (1) the pharmacy has reason to believe that the failure to dispense the controlled substance or additional drug would result in a serious hardship for the ultimate user or agent of the ultimate user, and documents the reason; and (2) the ultimate user or agent of the ultimate user prints his or her name and address on the reverse side of the prescription and signs his or her name thereto.

(C) The Commissioner may waive or modify the requirement in 105 CMR 701.004(A) for prescription refills, prescription deliveries or other activities/situations specified by the Commissioner.

REGULATORY AUTHORITY

105 CMR 701.000: M.G.L. c. 94C, § 4.

2/1/13 105 CMR - 4030 The text of the regulations published in the electronic version of the Massachusetts Register is unofficial and for informational purposes only. The official version is the printed copy which is available from the State Bookstore at http://www.sec.state.ma.us/spr/sprcat/catidx.htm. Docket # 1,123

THE COMMONWEALTH OF MASSACHUSETTS William Francis Galvin Secretary of the Commonwealth

Regulation Filing To be completed by filing agency

CHAPTER NUMBER: 105 CMR 721.000

CHAPTER TITLE: Standards for Prescription Format and Security in Massachusetts

AGENCY: Department of Public Health

SUMMARY OF REGULATION: State the general requirements and purposes of this regulation. This regulation establishes rules for prescription format and security. These amendments remove the requirement that a prescription issued by a nurse midwife include the name of a supervising physician. There are also minor technical amendments.

REGULATORY AUTHORITY: M.G.L. c. 94C, s. 7

AGENCY CONTACT: Alison J. Mehlman PHONE: 617-624-5232

ADDRESS: 250 Washington St., Boston, MA 02108

Compliance with M.G.L. c. 30A

EMERGENCY ADOPTION - if this regulation is adopted as an emergency, state the nature of the emergency.

PRIOR NOTIFICATION AND/OR APPROVAL - If prior notification to and/or approval of the Governor, Legislature or others was required, list each notification, and/or approval and date, including notice to the Local Government Advisory Commission. Massachusetts Municipal Association: 4/19/12 Executive Office of Communities and Development: 4/19/12

Date of public hearing or comment period: 11/9/12

For the first five years:

No fiscal effect: No fiscal effect for public or private sectors

Date amended small business impact statement was filed: 1/15/13

CODE OF MASSACHUSETTS REGULATIONS INDEX - List key subjects that are relevant to this regulation: Controlled Substances Prescription Drugs

ATTESTATION - The regulation described herein and attached hereto is a true copy of the regulation adopted by this agency. ATTEST:

SIGNATURE: SIGNATURE ON FILE DATE: Jan 17 2013

Publication - To be completed by the Regulations Division

MASSACHUSETTS REGISTER NUMBER: 1227 DATE: 02/01/2013

EFFECTIVE DATE: 02/01/2013

CODE OF MASSACHUSETTS REGULATIONS Remove these pages: Insert these pages: 4133 - 4136 4133 - 4136

01/17/2013 mrs

105 CMR 721.000: STANDARDS FOR PRESCRIPTION FORMAT AND SECURITY IN MASSACHUSETTS

Section

721.001: Purpose 721.002: Citation 721.003: Scope and Application 721.010: Definitions 721.020: Prescription Formats 721.030: Security Standards for Prescriptions 721.040: Invalid Prescriptions 721.050: Prescribing More than One Product

721.001: Purpose

The purpose of 105 CMR 721.000 is to specify the requirements for prescription format and security in Massachusetts.

721.002: Citation

105 CMR 721.000 shall be known as 105 CMR 721.000: Standards for Prescription Format and Security in Massachusetts.

721.003: Scope and Application

105 CMR 721.000 establishes the standards for format and security in the Commonwealth that all prescriptions issued by practitioners or reduced to writing by pharmacists must meet in order to comply with M.G.L. c. 112, § 12D and M.G.L. c. 94C.

721.010: Definitions

The terms used herein shall have the meanings set forth in 105 CMR 721.010. Terms defined in M.G.L. c. 112, § 12D and c. 94C, § 1 and not defined herein shall have the meanings set forth therein when used in 105 CMR 721.000, unless the context clearly requires a different interpretation.

Authentication means that the identities of the parties sending and receiving electronic prescription data are duly verified.

Confidentiality means that only authorized persons have access to prescription data.

Content Integrity means that the electronic prescription data have not been altered or compromised in transmission.

Drug Product means the final dosage form of a drug that is marketed under a brand or generic name.

Electronic Signature means an electronic sound, symbol or process attached to or logically associated with a prescription record and executed or adopted by a practioner with the intent to sign said prescription record.

Technical Non-repudiation means that parties to the generation, transmission, receipt or storage of an electronic prescription cannot reasonably deny having participated in said activities.

721.020: Prescription Formats

Every prescription written in the Commonwealth must be in a prescription format that conforms to the following requirements:

(A) a prescription must permit the practitioner to instruct the pharmacist to dispense a brand name drug product by indicating “no substitution”, provided that:

2/1/13 105 CMR - 4133 The text of the regulations published in the electronic version of the Massachusetts Register is unofficial and for informational purposes only. The official version is the printed copy which is available from the State Bookstore at http://www.sec.state.ma.us/spr/sprcat/catidx.htm. 105 CMR: DEPARTMENT OF PUBLIC HEALTH

721.020: continued

(1) the indication of “no substitution” is not the default indication; (2) the prescription indicates that “Interchange is mandated unless the practitioner indicates ‘no substitution’ in accordance with the law”; and (3) the indication of “no substitution” is a unique element in the prescription and shall not be satisfied by use of any other element, including the signature;

(B) if the prescription is paper-based, including but not limited to a prescription that is transmitted via facsimile or similar technology, or reduced to writing by a pharmacist, the prescription must be on a form that contains a signature line for the practitioner's signature on the lower portion of the form. Hospital and clinic prescription forms shall contain a line directly below the signature line for the practitioner to print or type his/her name. Below the signature line, or in the case of hospital and clinic prescription forms, below the line provided for the practitioner to print or type his or her name, there shall be a space in which the practitioner may indicate "no substitution". Below this space shall be printed the words "Interchange is mandated unless the practitioner indicates 'no substitution' in accordance with the law”;

(C) if the prescription is transmitted electronically, the practitioner shall generate and transmit the prescription in a format that can be read and stored by a pharmacy in a retrievable and readable form;

(D) the name and address of the practitioner shall be clearly indicated on the prescription. A hospital or clinic prescription shall have the name and address of the hospital or clinic clearly indicated on the prescription;

(E) the prescription shall contain the following information: (1) the registration number of the practitioner or nurse midwife; (2) date of issuance of the prescription; (3) name, dosage, and strength per dosage unit of the controlled substance prescribed, and the quantity of dosage units; (4) name and address of the patient, except in a veterinary prescription or a prescription for expedited partner therapy issued in accordance with 105 CMR 700.003(J), in which case the words “Expedited Partner Therapy”, “E.P.T.” or “EPT” may be used in place of the name of the patient, and the address may be left blank; (5) directions for use, including any cautionary statements required; (6) a statement indicating the number of times to be refilled;

(F) beginning July 1, 2013, a prescription must be written on a tamper-resistant form consistent with federal requirements for Medicaid; and

(G) a prescription issued by a nurse practitioner, psychiatric nurse, physician assistant, nurse anesthetist or pharmacist shall also contain the name of the supervising physician.

721.030: Security Standards for Prescriptions

(A) A prescription may be transmitted electronically provided that: (1) if said prescription is for a controlled substance in Schedules II through V, it is validated and authenticated in accordance with M.G.L. c. 94C and applicable Department regulations, if any, and 21 CFR 1306 and other applicable federal regulations; (2) if said prescription is for a controlled substance in Schedule VI it is validated and authenticated in accordance with requirements in M.G.L. c. 94C and applicable Department regulations for oral prescriptions or by utilizing a system that includes: (a) a combination of technical security measures, such as, but not necessarily limited to, those listed in Security Standards for the Protection of Electronic Protected Health Information (HIPAA), 45 CFR Part 164, Subpart C, § 164.312, to ensure a reasonable and appropriate level of: 1. practitioner and dispenser authentication; 2. technical non-repudiation; 3. content integrity; and 4. confidentiality.

2/1/13 105 CMR - 4134 The text of the regulations published in the electronic version of the Massachusetts Register is unofficial and for informational purposes only. The official version is the printed copy which is available from the State Bookstore at http://www.sec.state.ma.us/spr/sprcat/catidx.htm. 105 CMR: DEPARTMENT OF PUBLIC HEALTH

721.030: continued

(b) an electronic signature that is: 1. unique to an identified practitioner; 2. originated solely by and under the ultimate control of the practitioner; and 3. capable of verification. (c) reasonable and appropriate security measures to invalidate a prescription if either the electronic signature or the prescription record to which it is attached or logically associated is altered or compromised; and (3) said prescription meets any other generally applicable requirements of the federal Health Insurance Portability and Accountability Act (HIPAA) and related regulations.

(B) An electronic signature that meets the requirements of 105 CMR 721.031 shall have the full force and effect of a handwritten signature on a paper-based written prescription.

(C) A paper-based written prescription must be written and signed by the practitioner in accordance with M.G.L. c. 94C, § 23 and 105 CMR 721.000.

721.040: Invalid Prescriptions

(A) A prescription in a format that does not conform to 105 CMR 721.000 is invalid and shall not be filled.

(B) A prescription that does not meet the security requirements of 105 CMR 721.000 is invalid and shall not be filled.

721.050: Prescribing More Then One Drug Product

Practitioners who wish to prescribe more than one drug product, with the same or different dispensing instructions, shall place each prescription on a separate prescription form or record. More than one drug product may be prescribed in the hospital setting on a single form or record provided, however, that the prescription provides clear directions for use and interchange of each drug product.

REGULATORY AUTHORITY

105 CMR 721.000: M.G.L. c. 30A, § 2; c. 94C, § 6; c. 111, § 3; and c. 112, § 12D.

2/1/13 105 CMR - 4135 The text of the regulations published in the electronic version of the Massachusetts Register is unofficial and for informational purposes only. The official version is the printed copy which is available from the State Bookstore at http://www.sec.state.ma.us/spr/sprcat/catidx.htm. 105 CMR: DEPARTMENT OF PUBLIC HEALTH

NON-TEXT PAGE

2/1/13 105 CMR - 4136 The text of the regulations published in the electronic version of the Massachusetts Register is unofficial and for informational purposes only. The official version is the printed copy which is available from the State Bookstore at http://www.sec.state.ma.us/spr/sprcat/catidx.htm. Docket # 316

THE COMMONWEALTH OF MASSACHUSETTS William Francis Galvin Secretary of the Commonwealth

Regulation Filing To be completed by filing agency

CHAPTER NUMBER: 220 CMR 18.00

CHAPTER TITLE: Net Metering

AGENCY: Department of Public Utilities

SUMMARY OF REGULATION: State the general requirements and purposes of this regulation. Department of Public Utilities ("DPU") regulation 220 CMR 18.00 governs how Distribution Companies are to provide service to net metering customers and facilities. The emergency regulations, effective November 1, 2012, implemented amendments to the net metering provisions of G.L. c. 164, §§ 138 and 139 required by St. 2012, c. 209, §§ 23-30. In the final regulations, the DPU amended the emergency regulations by adding 220 CMR 18.07(8) which guarantees a small subset of Class I Net Metering Facilities the ability to net meter.

REGULATORY AUTHORITY: St. 2008, c. 169, § 78; St. 2010, c. 359, §§ 25 through 30; St. 2012, c. 209, § § 23 through 30. AGENCY CONTACT: Mike Wallerstein PHONE: (617) 305-3724

ADDRESS: One South Station, Boston, MA 02110

Compliance with M.G.L. c. 30A

EMERGENCY ADOPTION - if this regulation is adopted as an emergency, state the nature of the emergency.

PRIOR NOTIFICATION AND/OR APPROVAL - If prior notification to and/or approval of the Governor, Legislature or others was required, list each notification, and/or approval and date, including notice to the Local Government Advisory Commission. Notified Local Government Advisory Committee: 11/1/12 Notified Department of Environmental Protection: 11/1/12 Executive Office of Administration and Finance Approval: 1/17/13

Date of public hearing or comment period: Public Hearing: 12/13/12. Comment Period: 11/1/12 – 12/13/12

For the first five years: Approximately $116 million, which includes approximately $25 million for 2015 and $28 million per year for both 2016 and 2017 No fiscal effect:

Date amended small business impact statement was filed: 1/16/13

CODE OF MASSACHUSETTS REGULATIONS INDEX - List key subjects that are relevant to this regulation: Net Metering; Electric Industry Restructuring; Distribution Companies; Competitive Suppliers; Electricity Brokers

ATTESTATION - The regulation described herein and attached hereto is a true copy of the regulation adopted by this agency. ATTEST:

SIGNATURE: SIGNATURE ON FILE DATE: Jan 18 2013

Publication - To be completed by the Regulations Division

MASSACHUSETTS REGISTER NUMBER: 1227 DATE: 02/01/2013

EFFECTIVE DATE: 02/01/2013

CODE OF MASSACHUSETTS REGULATIONS Remove these pages: Insert these pages: 3, 4 3, 4 112.33 - 112.38 112.33 - 112.38

01/18/2013 mrs

Table of Contents Page

(220 CMR 10.00: RESERVED) 85

220 CMR 11.00: RULES GOVERNING THE RESTRUCTURING OF THE ELECTRIC INDUSTRY 110.1

Section 11.01: Purpose and Scope 110.1 Section 11.02: General Definitions 110.1 Section 11.03: Transition Cost Recovery 110.5 Section 11.04: Distribution Company Requirements 110.7 Section 11.05: Competitive Supplier and Electricity Broker Requirements 110.13 Section 11.06: Information Disclosure Requirements 110.16 Section 11.07: Complaint and Damage Claim Resolution; Penalties 110.22 Section 11.08: Exceptions 112

220 CMR 12.00: STANDARDS OF CONDUCT FOR DISTRIBUTION COMPANIES AND THEIR COMPETITIVE AFFILIATES 112.1

Section 12.01: Purpose and Scope 112.1 Section 12.02: Definitions 112.1 Section 12.03: General Standards of Conduct 112.2 Section 12.04: Pricing of Transactions Between Distribution Companies and Affiliates 112.4 Section 12.05: Penalties 112.4

220 CMR 13.00: CONSUMER PROTECTION FROM THE UNAUTHORIZED CHANGING OF LOCAL OR LONG DISTANCE TELEPHONE SERVICE PROVIDERS 112.5

Section 13.01: Purpose and Scope 112.5 Section 13.02: Definitions 112.5 Section 13.03: Requirements for Third Party Verification Calls 112.6 Section 13.04: Authorized Changes, Dispute Resolution Procedure for Slamming Complaints 112.7 Section 13.05: Informal Dispute Resolution Procedure for Slamming Complaints 112.7 Section 13.06: Procedure to Record Slamming Complaints 112.7 Section 13.07: Application Form for Third Party Verification Companies 112.8 Section 13.08: Exception 112.8

220 CMR 14.00: THE UNBUNDLING OF SERVICES RELATED TO THE PROVISION OF NATURAL GAS 112.9

Section 14.01: Purpose and Scope 112.9 Section 14.02: General Definitions 112.9 Section 14.03: Local Distribution Company Requirements 112.10 Section 14.04: Supplier and Retail Agent Requirements 112.13 Section 14.05: Information Disclosure Requirements 112.16 Section 14.06: Complaint and Damage Claim Resolution; Penalties 112.17 Section 14.07: Exceptions 112.18

10/3/08 220 CMR - 3 The text of the regulations published in the electronic version of the Massachusetts Register is unofficial and for informational purposes only. The official version is the printed copy which is available from the State Bookstore at http://www.sec.state.ma.us/spr/sprcat/catidx.htm. 220 CMR: DEPARTMENT OF PUBLIC UTILITIES

Table of Contents Page

220 CMR 15.00: ACCELERATED DOCKET FOR DISPUTES INVOLVING COMPETING TELECOMMUNICATIONS CARRIERS 112.19

Section 15.01: General Provisions 112.19 Section 15.02: Definitions 112.19 Section 15.03: Request for Expedited Review 112.19 Section 15.04: Docketing a Complaint on the Accelerated Docket 112.20 Section 15.05: Complaint and Answer 112.21 Section 15.06: Discovery; Automatic Disclosure 112.21 Section 15.07: Initial Status Conference 112.22 Section 15.08: Expedited Hearing 112.22 Section 15.09: Decision 112.23 Section 15.10: Exceptions 112.23

220 CMR 16.00: RULES GOVERNING THE RECOVERY OF EXPENSES RELATING TO THE PROVISION OF WIRELINE ENHANCED 911 (E-911) SERVICES, DUAL PARTY TDD/TTY MESSAGE RELAY SERVICES, AND ADAPTIVE EQUIPMENT SERVICES BY TELECOMMUNICATIONS CARRIERS 112.25

Section 16.01: Purpose and Scope 112.25 Section 16.02: Definitions 112.25 Section 16.03: Application of the Telephone Surcharge 112.26 Section 16.04: Establishment of the Funding Mechanism 112.28 Section 16.05: Reporting Requirements 112.28 Section 16.06: Miscellaneous 112.28

220 CMR 17.00: LONG-TERM CONTRACTS FOR RENEWABLE ENERGY 112.29

Section 17.01: Purpose and Scope 112.29 Section 17.02: Definitions 112.29 Section 17.03: General Terms and Conditions 112.29 Section 17.04: Methods for Soliciting and Entering Long-term Contracts 112.30 Section 17.05: General Criteria for Long-term Contracts and Renewable Energy Generation Sources 112.30 Section 17.06: Use of Energy and RECs Obtained through Long-term Contracts 112.30 Section 17.07: Remuneration to Distribution Companies 112.31 Section 17.08: Long-term Contracts and RPS Requirements 112.31 Section 17.09: Exceptions 112.31

220 CMR 18.00: NET METERING 112.33

Section 18.01: Purpose and Scope 112.33 Section 18.02: Definitions 112.33 Section 18.03: Net Metering Services 112.35 Section 18.04: Calculation of Net Metering Credits 112.35 Section 18.05: Allocation of Net Metering Credits 112.36 Section 18.06: Eligibility for Net Metering 112.36 Section 18.07: Net Metering Capacity 112.36 Section 18.08: Net Metering Reports 112.37 Section 18.09: Miscellaneous 112.38

220 CMR 19.00: STANDARDS OF PERFORMANCE FOR EMERGENCY PREPARATION AND RESTORATION OF SERVICE FOR ELECTRIC DISTRIBUTION AND GAS COMPANIES 112.39

Section 19.01: Purpose and Scope 112.39 Section 19.02: Definitions 112.39

2/1/13 220 CMR - 4 The text of the regulations published in the electronic version of the Massachusetts Register is unofficial and for informational purposes only. The official version is the printed copy which is available from the State Bookstore at http://www.sec.state.ma.us/spr/sprcat/catidx.htm. 220 CMR: DEPARTMENT OF PUBLIC UTILITIES

220 CMR 18.00: NET METERING

Section

18.01: Purpose and Scope 18.02: Definitions 18.03: Net Metering Services 18.04: Calculation of Net Metering Credits 18.05: Allocation of Net Metering Credits 18.06: Eligibility for Net Metering 18.07: Net Metering Capacity 18.08: Net Metering Reports 18.09: Miscellaneous

18.01: Purpose and Scope

(1) Purpose. 220 CMR 18.00 establishes regulations governing how Distribution Companies are to provide Net Metering services to Customers consistent with the net metering provisions of St. 2008, c. 169, an Act Relative to Green Communities, St. 2010, c. 359, an Act Making Appropriations for the Fiscal Years 2010 and 2011 to Provide for Supplementing Certain Existing Appropriations and for Certain Other Activities and Projects, and St. 2012, c. 209, §§ 23 through 30, an Act Relative to Competitively Priced Electricity in the Commonwealth. St. 2008, c. 169, § 78; St. 2010, c. 359, §§ 25 through 30; St. 2012, c. 209, §§ 23 through 30.

(2) Scope. 220 CMR 18.00 applies to all Distribution Companies subject to the jurisdiction of the Department.

18.02: Definitions

The terms set forth in 220 CMR 18.02 shall be defined as follows, unless the context otherwise requires.

Agricultural Net Metering Facility means a Renewable Energy generating facility that is operated as part of an agricultural business, generates electricity, does not have a generation capacity of more than two megawatts, is located on land owned or controlled by the agricultural business, and is used to provide energy to metered accounts of the business. “Agriculture” has the same meaning as provided in M.G.L. c. 128, § 1A; provided that, when necessary, the Commissioner of the Department of Agricultural Resources shall determine if a business is an agricultural business and whether the facility is operated as part of that business.

Anaerobic Digestion Net Metering Facility means a facility that (a) generates electricity from a biogas produced by the accelerated biodegradation of organic materials under controlled anaerobic conditions; (b) has been determined by the Department of Energy Resources, in coordination with the Department of Environmental Protection, to qualify under the Department of Energy Resources' regulations as a Class I renewable energy generating source under 225 CMR 14.00: Renewable Energy Portfolio Standard - Class I and M.G.L. c. 25A, § 11F; and (c) is interconnected to a Distribution Company.

Billing Period means the period of time set forth in a Distribution Company’s terms and conditions for which a Distribution Company bills a Customer for its electricity consumed or estimated to have been consumed.

Class I Net Metering Facility means a plant or equipment that is used to produce, manufacture, or otherwise generate electricity and that is not a transmission facility and that has a design capacity of 60 kilowatts or less.

Class II Net Metering Facility means an Agricultural Net Metering Facility, Anaerobic Digestion Net Metering Facility, Solar Net Metering Facility, or Wind Net Metering Facility with a generating capacity of more than 60 kilowatts but less than or equal to one megawatt; provided, however, that a Class II Net Metering Facility of a Municipality or Other Governmental Entity may have a generating capacity of more than 60 kilowatts but less than or equal to one megawatt per unit.

2/1/13 220 CMR - 112.33 The text of the regulations published in the electronic version of the Massachusetts Register is unofficial and for informational purposes only. The official version is the printed copy which is available from the State Bookstore at http://www.sec.state.ma.us/spr/sprcat/catidx.htm. 220 CMR: DEPARTMENT OF PUBLIC UTILITIES

18.02: continued

Class III Net Metering Facility means an Agricultural Net Metering Facility, Anaerobic Digestion Net Metering Facility, Solar Net Metering Facility, or Wind Net Metering Facility with a generating capacity of more than one megawatt but less than or equal to two megawatts; provided, however, that a Class III Net Metering Facility of a Municipality or Other Governmental Entity may have a generating capacity of more than one megawatt but less than or equal to two megawatts per unit.

Governmental Cooperative means a cooperative, organized pursuant to M.G.L. c. 164, § 136, whose members or shareholders are all Municipalities or Other Governmental Entities.

Customer means any person, partnership, corporation, or any other entity, whether public or private, who obtains distribution service at a customer delivery point and who is a customer of record of the Distribution Company for its own electricity consumption.

Distribution Company means a company engaging in the distribution of electricity or owning, operating or controlling distribution facilities; provided, however, that a distribution company shall not include any entity which owns or operates plant or equipment used to produce electricity, steam and chilled water, or an affiliate engaged solely in the provision of such electricity, steam and chilled water, where the electricity produced by such entity or its affiliate is primarily for the benefit of hospitals and non-profit educational institutions, and where such plant or equipment was in operation before January 1, 1986.

Host Customer means a Customer with a Class I, II, or III Net Metering Facility that generates electricity on the Customer’s side of the meter.

ISO-NE means ISO New England Inc., the independent system operator for New England, or its successor, authorized by the Federal Energy Regulatory Commission to operate the New England bulk power system and administer New England’s organized wholesale electricity market pursuant to the ISO-NE Tariff and operation agreements with transmission owners.

Municipality means a city or town.

Neighborhood means a geographic area within a Municipality, subject to the right of the Department to grant exceptions pursuant to 220 CMR 18.09(7), that: (a) is recognized by the residents as including a unique community of interests; (b) falls within the service territory of a single Distribution Company and within a single ISO-NE load zone; and (c) may encompass residential, commercial, and undeveloped properties.

Neighborhood Net Metering Facility means a Class I, II, or III Net Metering Facility that: (a) is owned by, or serves the energy needs of, a group of ten or more residential Customers that reside in a single Neighborhood and are served by a single Distribution Company; (b) may also be owned by, or serve the energy needs of, other Customers who reside in the same Neighborhood and are served by the same Distribution Company as the residential Customers that own or are served by the facility; and (c) is located within the same Neighborhood as the Customers that own or are served by the facility.

Net Metering means the process of measuring the difference between electricity delivered by a Distribution Company and electricity generated by a Class I, Class II, Class III Net Metering Facility and fed back to the Distribution Company.

Net Metering Facility of a Municipality or Other Governmental Entity means a Class II or III Net Metering Facility: (a) that is owned or operated by a Municipality or Other Governmental Entity; or (b) of which the Municipality or Other Governmental Entity is the Host Customer and is assigned 100% of the output.

Other Governmental Entity means a department or agency of the Federal government or of the Commonwealth, and any other entity as approved by the Department.

2/1/13 220 CMR - 112.34 The text of the regulations published in the electronic version of the Massachusetts Register is unofficial and for informational purposes only. The official version is the printed copy which is available from the State Bookstore at http://www.sec.state.ma.us/spr/sprcat/catidx.htm. 220 CMR: DEPARTMENT OF PUBLIC UTILITIES

18.02: continued

Renewable Energy means energy generated from any source that qualifies as a Class I or Class II Renewable Energy generating source under M.G.L. c. 25A, § 11F; provided, however, that after conducting administrative proceedings, the Department of Energy Resources, in consultation with the Department of Agricultural Resources, may add technologies or technology categories.

Solar Net Metering Facility means a facility for the production of electrical energy that uses sunlight to generate electricity and is interconnected to a Distribution Company.

Wind Net Metering Facility means a facility for the production of electrical energy that uses wind to generate electricity and is interconnected to a Distribution Company.

18.03: Net Metering Services

(1) Each Distribution Company shall provide services to Customers and Host Customers necessary to permit Net Metering, including those related to interconnection, metering and calculation and billing of Net Metering credits, as specified in the Distribution Company’s Net Metering tariffs pursuant to 220 CMR 18.09(2) and 220 CMR 18.09(3).

(2) Each Distribution Company shall be prohibited from imposing special fees on a Host Customer with a Class I Net Metering Facility such as backup charges and demand charges, or additional controls or liability insurance, provided that the facility meets the other requirements of the interconnection tariff, and all relevant safety and power quality standards.

(3) Each Distribution Company shall calculate a Net Metering credit as set forth in 220 CMR 18.04, and not bill a Host Customer for kilowatt-hour usage, for any Billing Period in which the kilowatt-hours generated by a Class I, II, or III Net Metering Facility exceed the kilowatt-hour usage of the Host Customer.

(4) Each Distribution Company shall bill a Host Customer for excess consumption for any Billing Period in which the kilowatt-hours consumed by a Host Customer exceed the kilowatt- hours generated by a Class I, II or III Net Metering Facility.

18.04: Calculation of Net Metering Credits

(1) For a Class I Wind Net Metering Facility, Class I Solar Net Metering Facility, Class I Agricultural Net Metering Facility, Class I Anaerobic Digestion Net Metering Facility, Class II Net Metering Facility, and Net Metering Facility of a Municipality or Other Governmental Entity, each Distribution Company shall calculate for each Billing Period a Net Metering credit equal to the product of the: (a) excess kilowatt-hours, by time-of-use if applicable; and (b) sum of the following Distribution Company charges applicable to the rate class under which the Host Customer takes service: 1. the default service kilowatt-hour charge (in the ISO-NE load zone where the Host Customer is located); 2. the distribution kilowatt-hour charge; 3. the transmission kilowatt-hour charge; and 4. the transition kilowatt-hour charge.

(2) For a Class I Net Metering Facility other than a Class I Wind Net Metering Facility, Class I Agricultural Net Metering Facility, Class I Anaerobic Digestion Net Metering Facility, or a Class I Solar Net Metering Facility, each Distribution Company shall calculate a Net Metering credit for each Billing Period as the product of the: (a) excess kilowatt-hours, by time-of-use if applicable; and (b) average monthly clearing price at the ISO-NE.

(3) For a Neighborhood Net Metering Facility or a Class III Net Metering Facility other than a Net Metering Facility of a Municipality or Other Governmental Entity, each Distribution Company shall calculate a Net Metering credit for each Billing Period as the product of the:

2/1/13 220 CMR - 112.35 The text of the regulations published in the electronic version of the Massachusetts Register is unofficial and for informational purposes only. The official version is the printed copy which is available from the State Bookstore at http://www.sec.state.ma.us/spr/sprcat/catidx.htm. 220 CMR: DEPARTMENT OF PUBLIC UTILITIES

18.04: continued

(a) excess kilowatt-hours, by time-of-use if applicable; and (b) sum of the following Distribution Company charges applicable to the rate class under which the Host Customer takes service: 1. the default service kilowatt-hour charge (in the ISO-NE load zone where the Host Customer is located); 2. the transmission kilowatt-hour charge; and 3. the transition kilowatt-hour charge.

(4) The calculation of Net Metering credits under 220 CMR 18.04 shall not include the demand side management and renewable energy kilowatt-hour charges set forth in M.G.L. c. 25, §§ 19 through 20.

(5) For any Billing Period for which a Distribution Company calculates a Net Metering credit for a Host Customer, the Distribution Company shall apply the Net Metering credit to the Host Customer’s account for the subsequent Billing Period, unless the Host Customer provides otherwise pursuant to 220 CMR 18.05. The Distribution Company shall carry forward, from Billing Period to Billing Period, any remaining Net Metering credit balance.

18.05: Allocation of Net Metering Credits

(1) For a Class I, II or III Net Metering Facility, each Distribution Company shall allocate Net Metering credits, as designated in writing by the Host Customer, to other Customers who are in the Distribution Company's service territory and are located in the same ISO NE load zone. The manner and form of credit designation shall be as specified in the Distribution Company's Net Metering Tariff pursuant to 220 CMR 18.09(2). Notwithstanding the foregoing, if the Host Customer is a Municipality or Other Governmental Entity, including a Governmental Cooperative, it may direct its Distribution Company to allocate Net Metering credits only to other Customers that are Municipalities or Other Governmental Entities.

(2) For a Neighborhood Net Metering Facility, the Distribution Company may only allocate Net Metering credits to residential or other Customers who reside in the same Neighborhood in which the Neighborhood Net Metering Facility is located and have an ownership interest in, or are served by, the Neighborhood Net Metering Facility.

(3) The Distribution Company shall carry forward, from Billing Period to Billing Period, any remaining Net Metering credit balance.

(4) For a Class III Net Metering Facility, a Distribution Company may elect to pay to the Host Customer Net Metering credits rather than allocating such credits pursuant to 220 CMR 18.05(1).

18.06: Eligibility for Net Metering

(1) Distribution Companies shall not provide Net Metering services to a Host Customer who is an electric company, generation company, aggregator, supplier, energy marketer, or energy broker, as those terms are used in M.G.L. c. 164, §§ 1 and 1F and 220 CMR 11.00: Rules Governing the Restructuring of the Electric Industry.

(2) A Governmental Cooperative shall not be considered an electric company, generation company, aggregator, supplier, energy marketer or energy broker, as those terms are used in M.G.L. c. 164, §§ 1 and 1F and 220 CMR 11.00: Rules Governing the Restructuring of the Electric Industry.

18.07: Net Metering Capacity

(1) Each Distribution Company shall make Net Metering services available to Host Customers such that the aggregate capacity of: (a) Net Metering Facilities that are not Net Metering Facilities of a Municipality or Other Governmental Entity does not exceed 3% of the Distribution Company’s highest historical peak load; and

2/1/13 220 CMR - 112.36 The text of the regulations published in the electronic version of the Massachusetts Register is unofficial and for informational purposes only. The official version is the printed copy which is available from the State Bookstore at http://www.sec.state.ma.us/spr/sprcat/catidx.htm. 220 CMR: DEPARTMENT OF PUBLIC UTILITIES

18.07: continued

(b) Net Metering Facilities of a Municipality or Other Governmental Entity does not exceed 3% of the Distribution Company's highest historical peak load.

(2) The maximum amount of generating capacity eligible for Net Metering by a Municipality or Other Governmental Entity shall be ten megawatts, as determined by the sum of the nameplate ratings of Class II and III Net Metering Facilities for which the Municipality or Other Governmental Entity is the Host Customer; except as provided in 220 CMR 18.07(6).

(3) Each Distribution Company shall identify on an annual basis its highest historical peak load and post that data on its website by February 1st of the following year.

(4) For the purpose of calculating the aggregate capacity of Class I, II, and III Net Metering Facilities, the capacity of a: (a) Solar Net Metering Facility shall be 80% of the facility’s direct current rating at standard test conditions; and (b) Wind Net Metering Facility, and all other non-solar net metering facilities, shall be the nameplate rating.

(5) A Class I Net Metering Facility shall be exempt from the calculation of the aggregate capacity of Net Metering facilities that are not Net Metering facilities of a Municipality or Other Governmental Entity if: (a) it is a Renewable Energy generating facility; and (b) its nameplate rating is equal to or less than 1. ten kilowatts on a single-phase circuit; or 2. 25 kilowatts on a three-phase circuit.

(6) A Municipality or Other Governmental Entity that is a member of a Governmental Cooperative may transfer any or all of the net metering generating capacity associated with one or more Class II or III Net Metering Facilities to said Governmental Cooperative by providing written assent to the Governmental Cooperative and obtaining approval from the Department.

(7) A Governmental Cooperative may serve as a Host Customer for a Net Metering Facility of a Municipality or Other Governmental Entity for all capacity allocated pursuant to 220 CMR 18.07(6) and its own capacity as an Other Governmental Entity, provided that the net metering credits for which such Governmental Cooperative serves as Host Customer shall only be allocated to that same Governmental Cooperative or its members.

(8) Notwithstanding the capacity limits set forth in 220 CMR 18.07, a Class I Net Metering Facility shall be eligible for Net Metering if it qualifies under the Department of Energy Resources' regulations as a Class I renewable energy generating source under 225 CMR 14.00: Renewable Energy Portfolio Standard - Class I and M.G.L. c. 25A, § 11F and its nameplate capacity is either: (a) equal to or less than ten kilowatts on a single-phase circuit; or (b) equal to or less than 25 kilowatts on a three phase circuit.

18.08: Net Metering Reports

(1) Each Distribution Company shall track at least the following: (a) the size, generation type, Net Metering class, fuel type, and the Municipality within which each Net Metering facility receives Net Metering services; (b) the size, generation type, fuel type, and the Municipality within which each Net Metering facility has requested interconnection with the Distribution Company; and (c) the aggregate capacity of Net Metering facilities that have interconnected, and that have requested interconnection, to the Distribution Company.

(2) Each Distribution Company shall file with the Department information regarding the provision of Net Metering services to its Customers, in a format and according to a schedule as determined by the Department.

2/1/13 220 CMR - 112.37 The text of the regulations published in the electronic version of the Massachusetts Register is unofficial and for informational purposes only. The official version is the printed copy which is available from the State Bookstore at http://www.sec.state.ma.us/spr/sprcat/catidx.htm. 220 CMR: DEPARTMENT OF PUBLIC UTILITIES

18.08: continued

(3) Each Distribution Company shall post data to a publicly accessible website tracking the aggregate capacity of eligible Net Metering facilities that have connected, and that have requested interconnection, relative to the Net Metering capacity set forth in 220 CMR 18.07. The data shall be updated on a monthly basis.

18.09: Miscellaneous

(1) The provision of Net Metering services does not entitle Distribution Companies to ownership of, or title to the renewable energy or environmental attributes, including renewable energy certificates, associated with any electricity produced by a Net Metering facility.

(2) Each Distribution Company shall implement its responsibilities and obligations regarding the provision of Net Metering services to Customers and Host Customers pursuant to a Department-approved tariff.

(3) Each Distribution Company shall implement its responsibilities and obligations regarding the provision of interconnection services to Customers and Host Customers pursuant to a Department-approved tariff.

(4) Each Distribution Company shall be allowed to recover the aggregate of the distribution portion of any Class I, II, or III Net Metering credits and the Distribution Company delivery charges displaced by a Class I, II or III Net Metering Facility through a uniform per kilowatt-hour surcharge or surcharges billed to all of its Customers on an annual basis.

(5) Nothing in 220 CMR 18.00 is intended in any way to limit eligibility for Net Metering services based upon a third party ownership or financing agreement related to a Net Metering facility, where Net Metering services would otherwise be available.

(6) Unless otherwise indicated, all capacity and energy measurements referenced in 220 CMR 18.00 refer to alternating current.

(7) The Department may, where appropriate, grant an exception from any provision of 220 CMR 18.00.

REGULATORY AUTHORITY

220 CMR 18.00: St. 2008, c. 169, § 78, St. 2010, c. 359, §§ 25 through 30; St. 2012, c. 209, §§ 23 through 30.

2/1/13 220 CMR - 112.38 The text of the regulations published in the electronic version of the Massachusetts Register is unofficial and for informational purposes only. The official version is the printed copy which is available from the State Bookstore at http://www.sec.state.ma.us/spr/sprcat/catidx.htm. Docket # 77

THE COMMONWEALTH OF MASSACHUSETTS William Francis Galvin Notice of Compliance Secretary of the Commonwealth Regulation Filing To be completed by filing agency

CHAPTER NUMBER: 247 CMR 2.00

CHAPTER TITLE: Definitions

AGENCY: Board of Registration in Pharmacy

THIS REGULATION WAS ORIGINALLY FILED AS AN EMERGENCY: Published in Massachusetts Register Number: 1222 Date: 11/23/2012

Date of public hearing or comment period: December 4, 2012

Date amended small business impact statement was filed: January 14, 2013

AGENCY CONTACT: Heather A. Engman PHONE: 617-973-0992

ADDRESS: DPH/DHPL/Board of Registration in Pharmacy/ 239 Causeway Street, Boston, MA 02114 ATTESTATION - The regulation described herein and attached hereto is a true copy of the regulation adopted by this agency. ATTEST:

SIGNATURE ON FILE Jan 17 2013 SIGNATURE: DATE:

01/17/2013 mrs

Table of Contents Page

(247 CMR 1.00: RESERVED) 5

247 CMR 2.00: DEFINITIONS 7

Section 2.00: Definitions 7

247 CMR 3.00: PERSONAL REGISTRATION REQUIREMENTS 13

Section 3.01: Examination for Personal Registration as a Pharmacist 13 Section 3.02: Personal Registration by Reciprocity 14 Section 3.03: Duplicate Certificate of Personal Registration 15

247 CMR 4.00: PERSONAL REGISTRATION RENEWAL; CONTINUING EDUCATION REQUIREMENT 19

Section 4.01: Authority and Purpose 19 Section 4.02: Personal Registration Expiration and Renewal 19 Section 4.03: Continuing Education Requirement 20 Section 4.04: Board Continuing Education Committee 20 Section 4.05: Criteria for Board Approval of Continuing Education Programs 21 Section 4.06: Certificate of Completion of CEU's 22 Section 4.07: Record-keeping by Authorized Providers 22 Section 4.08: Record-keeping by Registered Pharmacists 23 Section 4.09: Continuing Education Credit for Pharmacist Instructors 23 Section 4.10: Continuing Education Credit for Postgraduate Pharmacy Curriculum/ Program 23

247 CMR 5.00: ORALLY AND ELECTRONICALLY TRANSMITTED PRESCRIPTIONS; PRESCRIPTION MONITORING PROGRAM (PMP) REPORTING REQUIREMENTS 25

Section 5.01: Foreword 25 Section 5.02: Electronically Transmitted Prescriptions 25 Section 5.03: Emergency Situations in Which Controlled Substances in Schedule II May be Dispensed Upon Orally or Electronically Transmitted Prescription 25 Section 5.04: Reporting Requirements to the Prescription Monitoring Program (PMP) 26

247 CMR 6.00: REGISTRATION, MANAGEMENT AND OPERATION OF A PHARMACY OR PHARMACY DEPARTMENT 29

Section 6.01: Application for a Registration to Manage and Operate a Pharmacy or Pharmacy Department; Inspection of Proposed Pharmacy or Pharmacy Department 29 Section 6.02: Conditions for Continuing Registration and Operation of a Pharmacy or Pharmacy Department 31 Section 6.03: Requirements for Reporting to the Board a Change in the Management, Operation and/or Ownership of a Pharmacy or Pharmacy Department 32 Section 6.04: Requirements for Reporting to the Board Changes in the Configuration, Square Footage or Location of a Pharmacy or Pharmacy Department 33 Section 6.05: Continuing Responsibilities of All Registered Pharmacists 34 Section 6.06: Renewal of a Pharmacy Permit 34 Section 6.07: Pharmacist Manager of Record 34 Section 6.08: Certificate of Fitness Issued by the Board Permitting Manufacture and Sale of Alcoholic Beverages 35 Section 6.09: Closing a Pharmacy or Pharmacy Department 36 Section 6.10: Distribution of Controlled Substances Upon Discontinuance or Transfer of Business of a Pharmacy or Pharmacy Department 37

2/10 /10 247 CMR - 1 The text of the regulations published in the electronic version of the Massachusetts Register is unofficial and for informational purposes only. The official version is the printed copy which is available from the State Bookstore at http://www.sec.state.ma.us/spr/sprcat/catidx.htm. 247 CMR: BOARD OF REGISTRATION IN PHARMACY

Table of Contents Page

247 CMR 6.00: REGISTRATION, MANAGEMENT AND OPERATION OF A PHARMACY OR PHARMACY DEPARTMENT (continued)

Section 6.11: Inspections of Pharmacies and Pharmacy Departments 37 Section 6.12: Deficiency Statements 38 Section 6.13: Plans of Correction 38 Section 6.14: Duty to Report Certain Improper Drug Dispensing to the Board 38 Section 6.15: Duty to Report Certain Factors of Pharmacy Operations 38.1

247 CMR 7:00: WHOLESALE DRUGGISTS 39

Section 7.01: Scope and Purpose 39 Section 7.02: Licensing Requirements 39 Section 7.03: Penalties 40 Section 7.04: Minimum Requirements for the Storage and Handling of Prescription Drugs and for the Establishment and Maintenance of Prescription Drug Distribution Records 41

247 CMR 8.00: PHARMACY INTERNS AND TECHNICIANS 45

Section 8.01: Pharmacy Interns 45 Section 8.02: Pharmacy Technicians 46 Section 8.03: Pharmacy Technician Trainees 47 Section 8.04: Certified Pharmacy Technicians 48 Section 8.05: Requirements for the Handling of Schedule II Controlled Substances by Pharmacy Interns, Certified Pharmacy Technicians, Pharmacy Technicians, and Pharmacy Technician Trainees 48 Section 8.06: Duties of Pharmacist Utilizing Pharmacy Interns, Certified Pharmacy Technicians, Pharmacy Technicians, and Pharmacy Technician Trainees 48.1 Section 8.07: Registration and Renewal Procedures; General Requirements 48.1

247 CMR 9.00: CODE OF PROFESSIONAL CONDUCT; PROFESSIONAL STANDARDS FOR REGISTERED PHARMACISTS, PHARMACIES AND PHARMACY DEPARTMENTS 49

Section 9.01: Code of Professional Conduct for Registered Pharmacists, Pharmacies and Pharmacy Departments 49 Section 9.02: Transfer of Prescriptions 50 Section 9.03: Advertising 51 Section 9.04: Requirements for Dispensing and Refilling Prescriptions 52 Section 9.05: Maintenance of Prescription Files 53 Section 9.06: Procedures for Verifying a Practitioner's Prescriptive Authority 53 Section 9.07: Maintaining Patient Records, Conducting a Prospective Drug Utilization Review and Patient Counseling 53

247 CMR 10.00: DISCIPLINARY PROCEEDINGS 55

Section 10.01: Purpose 55 Section 10.02: Definitions 55 Section 10.03: Grounds for Discipline 55 Section 10.04: Investigative Conference 56 Section 10.05: Disposition by the Board 56 Section 10.06: Disciplinary Action 56 Section 10.07: Suspension Prior to Hearing 56.1 Section 10.08: Summary Cease and Desist and Quarantine Notice 56.2

2/1/13 247 CMR - 2 The text of the regulations published in the electronic version of the Massachusetts Register is unofficial and for informational purposes only. The official version is the printed copy which is available from the State Bookstore at http://www.sec.state.ma.us/spr/sprcat/catidx.htm. 247 CMR: BOARD OF REGISTRATION IN PHARMACY

247 CMR 2.00: DEFINITIONS

Section

2.00: Definitions

Additional definitions pertaining to:

(1) nuclear pharmacies are contained in 247 CMR 13.00: Registration Requirements and Minimal Professional Standards for Nuclear Pharmacies;

(2) disciplinary proceedings are contained in 247 CMR 10.00: Disciplinary Proceedings; and

(3) continuous quality improvement programs are contained in 247 CMR 15.00: Continuous Quality Improvement Program; and

(4) duty to report certain factors of pharmacy operations are contained in 247 CMR 6.15: Duty to Report Certain Factors of Pharmacy Operations.

The following definitions apply to 247 CMR.

ACPE means the Accreditation Council for Pharmacy Education.

ACPE-approved Provider means an institution, organization or agency that is recognized by the ACPE, in accordance with its policies and procedures, as qualified to provide continuing education for pharmacists.

Approved College/School of Pharmacy means a college or school of pharmacy which has been accredited by the ACPE or approved by the Board.

Authorized Provider means a person who or agency which, sponsors or co-sponsors one or more contact hours of continuing education for pharmacists and which has received the approval of the ACPE, CME/Category 1, or the Board.

Blood means whole blood collected from a single donor and processed, whether for transfusion or further manufacturing.

Blood Component means that part of blood separated by physical or mechanical means.

Board means the Massachusetts Board of Registration in Pharmacy.

Board-approved Program means a program which has been approved by the Board for continuing education credits. Such program may be sponsored by the ACPE, and/or sponsored or co- sponsored by any person who has been granted prior written approval by the Board for the particular program. The Board may, within its discretion, accept comparable continuing education hours approved by other Boards of Pharmacy.

Certificate of Approved CEUs means a document, issued to a named pharmacist by an authorized provider, certifying that the pharmacist has satisfactorily completed a specified number of CEUs.

Certificate of Fitness means a document issued by the Board to a pharmacy or pharmacy department which permits a pharmacy or pharmacy department to use alcohol for the manufacture of U.S. Pharmacopoeia or National Formulary preparations and all medicinal preparations unfit for beverage purposes, and to sell alcohol as authorized under M.G.L. c. 138.

Certified Pharmacy Technician means a pharmacy technician who is currently: (a) registered by the Board; and (b) certified by a Board-approved certifying body.

2/1/13 (Effective 11/1/12) 247 CMR - 7 The text of the regulations published in the electronic version of the Massachusetts Register is unofficial and for informational purposes only. The official version is the printed copy which is available from the State Bookstore at http://www.sec.state.ma.us/spr/sprcat/catidx.htm. 247 CMR: BOARD OF REGISTRATION IN PHARMACY

2.00: continued

A pharmacy technician may perform the duties authorized to be performed by a certified pharmacy technician in 247 CMR 8.04: Certified Pharmacy Technicians when Board-approved certification is current. If certification lapses, the individual is required to function as a pharmacy technician until certification is current.

Contact Hour means a unit of measure of educational credit which is a minimum of 50 minutes, or the equivalent as determined by the Board, of satisfactory participation in a Board-approved program of continuing education.

Continuing Education (CE) means participation by registered pharmacists in Board-approved educational programs and is a prerequisite for the renewal of a personal registration.

Continuing Education Unit (CEU) means a unit of measure of educational credit which is equal to ten contact hours, or it's equivalent as determined by the Board, of satisfactory participation in a Board-approved program of continuing education.

Controlled Substance means a drug, substance, or immediate precursor in any schedule or class referred to in M.G.L. c. 94C.

Controlled Substance Registration means a document issued by the Board which allows the holder to receive and dispense, pursuant to a valid prescription, controlled substances.

CME/Category 1 means continuing medical education (CME) credits sponsored by an organization accredited for CME by the Accreditation Council for Continuing Medical Education, the Postgraduate Medical Institute or the state medical society.

Department means the Massachusetts Department of Public Health.

Direct Supervision means: (a) the type of supervision a Board-approved registered pharmacist preceptor in a pharmacy, pharmacy department, or institutional pharmacy is required to provide to a pharmacy intern when said preceptor oversees and directs the professional activities of the pharmacy intern, and includes directly reviewing the work of the intern; and (b) the type of supervision a registered pharmacist in a pharmacy, pharmacy department, hospital pharmacy, or institutional pharmacy is required to provide a pharmacy technician when said pharmacist oversees and directs the activities of the pharmacy technician.

Dispensing means the physical act of delivering a drug, chemical, device or combination thereof to an ultimate user pursuant to the lawful order of a practitioner, as defined in M.G.L. c. 94C, § 1, including the utilization of the professional judgment of the pharmacist and the packaging, labeling, or compounding necessary to prepare the drug, chemical, or device for delivery.

Drug Sample means a unit of a prescription drug that is not intended to be sold.

Electronically Transmitted Prescription means an order of a practitioner which has been transmitted electronically to a pharmacy in accordance with 105 CMR 721.020: Prescription Formats.

Facsimile Machine (fax) means a machine that electronically transmits exact images through connection with an electronic network.

FPGEC means the NABP's Foreign Pharmacy Graduate Examination Committee.

FPGEC Certificate means a document issued by the NABP evidencing the assessment of the educational equivalency of a graduate of a non-approved college/school of pharmacy.

2/1/13 (Effective 11/1/12) 247 CMR - 8 The text of the regulations published in the electronic version of the Massachusetts Register is unofficial and for informational purposes only. The official version is the printed copy which is available from the State Bookstore at http://www.sec.state.ma.us/spr/sprcat/catidx.htm. 247 CMR: BOARD OF REGISTRATION IN PHARMACY

2.00: continued

FPGEC Certification means the NABP’s Foreign Pharmacy Graduate Examination Committee’s process of documenting and assessing the educational equivalency of a graduate of a non- approved college/school of pharmacy.

FPGEE means the NABP’s Foreign Pharmacy Graduate Equivalency Examination.

Good Moral Character means those virtues of a person which are generally recognized as beneficial to the public health, safety and welfare.

Good Standing means the pharmacist’s personal registration is not currently being sanctioned by the Board.

Graduate of Non-approved College/School of Pharmacy means a pharmacist whose undergraduate pharmacy degree was not conferred by an ACPE-accredited or Board-approved college/school of pharmacy yet was conferred by a recognized college/school of pharmacy outside of the United States, the District of Columbia and Puerto Rico. Recognized colleges/schools of pharmacy are those colleges and universities listed in the World Health Organization’s World Directory of Schools of Pharmacy, or otherwise approved by the FPGEC.

Home-study and Other Mediated Instruction means continuing education activities which do not provide for direct interaction between faculty and participants and may include audio tapes, video tapes, cable television, computer assisted instruction, journal articles and monographs.

Institutional Pharmacy means the physical portion of an organization, including but not limited to hospitals, health maintenance organizations and clinic pharmacies, whose primary purpose is to a provide a physical environment for patients to obtain health care services under the supervision and direction of a registered pharmacist and is authorized to dispense controlled substances.

Internship means the period of training under the supervision of a Board-approved registered pharmacist preceptor, which training is a prerequisite to examination for personal registration as a pharmacist in the Commonwealth of Massachusetts.

Legend Drug, Device or Gas means a drug, device or gas which by federal law must bear the legend: "Caution: Federal law prohibits dispensing without prescription."

Live Program means a continuing education program that provides for direct interaction between faculty and participants and may include, but not be limited to, lectures, symposia, live teleconferences and workshops.

Manager of Record or Pharmacist Manager of Record means a pharmacist, currently registered by the Board pursuant to 247 CMR 6.07: Pharmacist Manager of Record, who is responsible for the operation of a pharmacy or pharmacy department in conformance with all laws and regulations pertinent to the practice of pharmacy and the distribution of drugs.

Manufacturer means a person who is engaged in manufacturing, preparing, propagating, compounding, processing, packaging, repackaging or labeling a prescription drug.

MPJE means the Multistate Pharmacy Jurisprudence Examination.

NABP means the National Association of Boards of Pharmacy.

NABP Number means a unique seven digit number issued by the National Council for Prescription Drug Programs.

NAPLEX means the North American Pharmacist Licensure Examination.

2/1/13 (Effective 11/1/12) 247 CMR - 9 The text of the regulations published in the electronic version of the Massachusetts Register is unofficial and for informational purposes only. The official version is the printed copy which is available from the State Bookstore at http://www.sec.state.ma.us/spr/sprcat/catidx.htm. 247 CMR: BOARD OF REGISTRATION IN PHARMACY

2.00: continued

National Drug Code (NDC) Number means a nationally recognized standard which identifies drug products using a unique number issued by the United States Food and Drug Administration. The NDC number has three components: the first component identifies the drug manufacturer ("Labeler No."); the second component identifies the product ("Product No."); and the third component identifies the package size ("Pkg.").

NCPDP means the National Council for Prescription Drug Programs.

Over-the-counter Drug means any drug whose availability is not restricted to an order of a practitioner.

Person means an individual, corporation, government, governmental subdivision or agency, business trust, estate trust, partnership or association, or any other legal entity.

Personal Registration means a document issued by the Board to a qualified pharmacist, under the provisions of M.G.L. c. 112, § 24, permitting the pharmacist to engage in the practice of pharmacy.

Pharmacy means a facility under the direction or supervision of a registered pharmacist which is authorized to dispense controlled substances. The term "pharmacy" shall not include institutional pharmacies or pharmacy departments except as otherwise provided in 247 CMR.

Pharmacy Department means that part of a retail store registered by the Board in which a drug business, as defined in M.G.L. c. 112, § 37, is transacted.

Pharmacy Intern means an individual who has completed two years of academic curriculum or who has standing as a student beyond the second-year class in the undergraduate academic sequence of an approved college/school of pharmacy, and who is registered by the Board to acquire, under the direction of a Board-approved registered pharmacist preceptor to whom he or she has been assigned, that practical experience which is a prerequisite to examination for personal registration as a pharmacist. A pharmacy intern may engage in the full range of activities conducted by a registered pharmacist provided that at all time he or she is under the direct supervision of a registered pharmacist preceptor.

Pharmacy Permit means a document issued by the Board to a registered pharmacist in the name of a pharmacy or pharmacy department to manage and operate a pharmacy or a pharmacy department.

Pharmacy Technician means an individual who is registered by the Board, pursuant to 247 CMR 8.02: Pharmacy Technicians, who performs pharmacy duties under the direct supervision of a pharmacist.

Pharmacy Technician Trainee means an individual preparing to be registered as a pharmacy technician who performs pharmacy duties under the direct supervision of a pharmacist.

Postgraduate means graduation and award of an entry-level degree in pharmacy from a Board- approved or ACPE-accredited college/school of pharmacy.

Practitioner means any person with prescriptive privileges as defined in M.G.L. c. 94C, § 1.

Preceptor means a registered pharmacist in good standing who has completed at least one year of the actual practice of pharmacy and who the Board has approved to supervise and direct the training of pharmacy interns and to assist in the training of other pharmacy interns.

Prescription means an order for a drug, chemical, device or combination thereof, either written, given orally or otherwise transmitted to a registered pharmacy by a practitioner or his or her expressly authorized agent, to be dispensed or compounded in a registered pharmacy and dispensed by a registered pharmacist to a patient or his or her agent with necessary and appropriate counseling.

2/1/13 (Effective 11/1/12) 247 CMR - 10 The text of the regulations published in the electronic version of the Massachusetts Register is unofficial and for informational purposes only. The official version is the printed copy which is available from the State Bookstore at http://www.sec.state.ma.us/spr/sprcat/catidx.htm. Docket # 80

THE COMMONWEALTH OF MASSACHUSETTS William Francis Galvin Secretary of the Commonwealth

Regulation Filing To be completed by filing agency

CHAPTER NUMBER: 247 CMR 6.00

CHAPTER TITLE: Registration, Management and Operation of a Pharmacy or Pharmacy Department AGENCY: Board of Registration in Pharmacy

SUMMARY OF REGULATION: State the general requirements and purposes of this regulation. Clarifies requirement that pharmacy obtain Board of Registration in Pharmacy approval prior to operation of central intravenous admixture services (revisions to 247 CMR 6.01(5)(c)).

Establishes pharmacy and pharmacist duty to report certain factors of pharmacy operations to the Board of Registration in Pharmacy (new 247 CMR 6.15).

REGULATORY AUTHORITY: M.G.L. c. 112, s. 42A

AGENCY CONTACT: Heather A. Engman PHONE: 617-973-0992

ADDRESS: DPH/DHPL/Board of Registration in Pharmacy, 239 Causeway Street, 5th Floor, Boston, MA 02114 Compliance with M.G.L. c. 30A

EMERGENCY ADOPTION - if this regulation is adopted as an emergency, state the nature of the emergency. This regulation was initially adopted as an emergency regulation on November 1, 2012. Immediate implementation of the duty to report certain factors of pharmacy operations was necessary to protect the public health, safety, and welfare.

Date of public hearing or comment period: December 4, 2012

For the first five years:

No fiscal effect: Minimal costs associated with additional reporting requirements.

Date amended small business impact statement was filed: January 14, 2013

CODE OF MASSACHUSETTS REGULATIONS INDEX - List key subjects that are relevant to this regulation: Pharmacist Pharmacy Pharmacy Department

PROMULGATION - State the action taken by this regulation and its effect on existing provisions of the Code of Massachusetts Regulations (CMR) or repeal, replace or amend. List by CMR number: Amends 247 CMR by revising 6.01(5)(c) and inserting a new section 6.15.

ATTESTATION - The regulation described herein and attached hereto is a true copy of the regulation adopted by this agency. ATTEST:

SIGNATURE: SIGNATURE ON FILE DATE: Jan 17 2013

Publication - To be completed by the Regulations Division

MASSACHUSETTS REGISTER NUMBER: 1227 DATE: 02/01/2013

EFFECTIVE DATE: 02/01/2013

CODE OF MASSACHUSETTS REGULATIONS Remove these pages: Insert these pages: 29 - 32 29 - 32 37, 38 37 - 38.2

01/17/2013 mrs

247 CMR 6.00: REGISTRATION, MANAGEMENT AND OPERATION OF A PHARMACY OR PHARMACY DEPARTMENT

Section

6.01: Application for a Registration to Manage and Operate a Pharmacy or Pharmacy Department; Inspection of Proposed Pharmacy or Pharmacy Department 6.02: Conditions for Continuing Registration and Operation of a Pharmacy or Pharmacy Department 6.03: Requirements for Reporting to the Board a Change in the Management, Operation and/or Ownership of a Pharmacy or Pharmacy Department 6.04: Requirements for Reporting to the Board Changes in the Configuration, Square Footage or Location of a Pharmacy or Pharmacy Department. 6.05: Continuing Responsibilities of All Registered Pharmacists 6.06: Renewal of a Pharmacy Permit 6.07: Pharmacist Manager of Record 6.08: Certificate of Fitness Issued by the Board Permitting the Manufacture and Sale of Alcoholic Beverages 6.09: Closing a Pharmacy or Pharmacy Department 6.10: Distribution of Controlled Substances Upon Discontinuance or Transfer of Business of a Pharmacy or Pharmacy Department 6.11: Inspections of Pharmacies and Pharmacy Departments 6.12: Deficiency Statements 6.13: Plans of Correction 6.14: Duty to Report Certain Improper Drug Dispensing to the Board 6.15: Duty to Report Certain Factors of Pharmacy Operations

6.01: Application for Registration to Manage and Operate a Pharmacy or Pharmacy Department; Inspection of a Proposed Pharmacy or Pharmacy Department

(1) In order to be registered by the Board to manage and operate a pharmacy or pharmacy department and be issued a permit to do so, the registered pharmacist who shall be responsible for the management and operation of the pharmacy or pharmacy department shall obtain and submit to the Board an application for registration to manage and operate a pharmacy or pharmacy department available from the Board. A completed application shall be: (a) fully and properly completed and signed, under the penalties of perjury, by the pharmacist who is to manage and operate the pharmacy or pharmacy department; (b) accompanied by a statement of the scheduled hours during which the pharmacy or pharmacy department is to remain open, including the time of opening and closing during regular business hours for each day of the week; (c) accompanied by an application, available from the Board, for a Massachusetts controlled substance registration; (d) accompanied by an application, available from the Board, for a certificate of fitness, if applicable; (e) accompanied by a check or money order made payable, in the proper amount, to the “Commonwealth of Massachusetts Board of Registration in Pharmacy”; and (f) accompanied by any additional information as determined by the Board.

(2) A completed application to operate a pharmacy shall include: (a) a copy of the corporation's Articles of Organization, signed and sealed by the Secretary of the Commonwealth if the corporation is incorporated in the Commonwealth; (b) a copy of the corporation's Foreign Corporation Certificate, signed and sealed by the Secretary of the Commonwealth pursuant to M.G.L. c. 181, § 4, if the corporation in incorporated in another state; (c) a statement of the name and address of each officer and director of the corporation and the position held; (d) the d/b/a (doing business as) name of the corporation; and (f) if the corporation is not publicly owned, the total amount and type of stock issued to each stockholder and the names and addresses of said stockholder(s).

(3) The Board shall not register nor permit ownership of a pharmacy or pharmacy department by a practitioner with prescriptive privileges.

(4) Before acting upon any application for registration to manage and operate a pharmacy or pharmacy department, the Board may require a hearing and, if requested to do so, the applicant

2/1/13 247 CMR - 29 The text of the regulations published in the electronic version of the Massachusetts Register is unofficial and for informational purposes only. The official version is the printed copy which is available from the State Bookstore at http://www.sec.state.ma.us/spr/sprcat/catidx.htm. 247 CMR: BOARD OF REGISTRATION IN PHARMACY

6.01: continued

shall personally appear before the Board to answer questions to enable the Board to determine that issuance of a permit would be in the best interests of the public health, welfare and safety as set forth in M.G.L. c. 112, § 39.

(5) The Board may require an inspection of the pharmacy or pharmacy department before final approval of the application is granted. All proposed pharmacies and pharmacy departments shall comply with the following requirements: (a) No application for registration to manage and operate a pharmacy or pharmacy department shall be approved unless, upon inspection, the following is maintained on the pharmacy premises: 1. a current copy or electronic version of the Massachusetts List of Interchangeable Drugs (MLID), including the Orange Book, Additional List, Exception List; 2. a current copy or electronic version (with quarterly updates) of a compendia appropriate to the practice setting approved by the pharmacist manager of record. 3. a current copy or electronic version of the Board Regulations (247 CMR); 4. a balance capable of accurately weighing quantities as small as 13 milligrams, which balance shall be tested and sealed by the state or local sealer of weights and measures annually; 5. the equipment necessary to conduct the practice of pharmacy according to the standards set forth by most current edition of the United States Pharmacopoeia; 6. prescription labels which bear the name and address of the proposed pharmacy; 7. appropriate sanitary appliances, including a suitable sink which shall be equipped for hot and cold running water and which shall be situated in or near the area in which prescriptions are to be filled; 8. whenever applicable, at least one bound book for recording sales of controlled substances which may be sold over-the-counter without a prescription; and 9. whenever applicable, at least one book for recording sales of alcoholic beverages and signatures of the purchasers of these beverages. (b) There shall be within every pharmacy or pharmacy department a prescription area of not less than 300 square feet to accommodate the appropriate pharmaceutical equipment, apparatus, and supplies, and to facilitate the proper preparation and compounding of prescribed medications. This area shall provide for an arrangement and storage of drugs that is calculated to prevent their accidental misuse. (c) Any pharmacy or pharmacy department which establishes a central intravenous admixture service (CIVAS) or performs sterile compounding shall, in addition to the 300 square feet required by 247 CMR 6.01(5)(b), provide for a separate room referred to as a "clean room" apart from all other areas of the pharmacy or pharmacy department. The pharmacy shall obtain approval from the Board indicating compliance with 247 CMR 6.01 and United States Pharmacopeia General Chapter 797 prior to initial operation of central intravenous admixture services or performance of any sterile compounding. The Board's approval shall be conspicuously posted and visible to the public, on the pharmacy premises. This clean room shall meet the following requirements: 1. There shall be a minimum working area of 72 square feet; 2. it shall be closed on all sides except for a door and an opening to allow for the passage of materials; 3. it shall have a laminar flow hood with either vertical or horizontal air flow; 4. the laminar flow hood standards of operation of HEPA (High Energy Particulate Air) filters and prefilters must be determined and certification shall be made annually by a Board-approved hood certification service; 5. the Board shall be notified before beginning operation of the clean room to verify hood certification; 6. the area of the clean room shall be under continual positive pressure unless the hood is self-venting; and 7. applications for construction of a pharmacy with a clean room received after September 30, 1996 shall show the clean room located directly adjacent to the prescription area/department. (d) Patient Consultation Area. 1. A pharmacy must provide a designated consultation area, with signage stating “Patient Consultation Area”, designed to provide adequate privacy for confidential visual and auditory patient counseling. The private consultation area must be accessible by a patient from the outside of the prescription dispensing area without having to traverse a stockroom or the prescription dispensing area.

2/1/13 247 CMR - 30 The text of the regulations published in the electronic version of the Massachusetts Register is unofficial and for informational purposes only. The official version is the printed copy which is available from the State Bookstore at http://www.sec.state.ma.us/spr/sprcat/catidx.htm. 247 CMR: BOARD OF REGISTRATION IN PHARMACY

6.01: continued

2. 247 CMR 6.01(5)(d) shall be effective for all new or relocating pharmacies on April 1, 2005. All existing pharmacies must comply with 247 CMR 6.01(5)(d) by January 1, 2007.

(6) The Board shall issue a permit indicating the pharmacy or pharmacy department’s registration number if the Board finds, in its reasonable discretion, that approving the application would be consistent with the best interest of public health, welfare and safety.

(7) All fees submitted to the Board in connection with an application for registration to operate a pharmacy or pharmacy department, which are reviewed and acted upon by the Board, are nonrefundable.

6.02: Conditions for Continuing Registration and Operation of a Pharmacy or Pharmacy Department

Except as provided by exemptions set forth in 247 CMR 12.00: Restricted Pharmacy with respect to restricted pharmacies and 247 CMR 13.00: Registration Requirements and Minimal Professional Standards for Nuclear Pharmacies with respect to nuclear pharmacies, the following conditions shall apply to the continuing operation of a pharmacy or pharmacy department:

(1) The premises of the pharmacy or pharmacy department shall at all times be kept in a clean and sanitary manner.

(2) The equipment and publications set forth in 247 CMR 6.01(5)(a) shall be maintained in the pharmacy or pharmacy department at all times.

(3) The following shall be conspicuously displayed within the pharmacy or pharmacy department: (a) the pharmacy permit; (b) the pharmacy's Massachusetts controlled substance registration; (c) the pharmacy's U.S. Drug Enforcement Administration controlled substance registration; and (d) whenever applicable, the pharmacy's certificate of fitness.

(4) The pharmacy or pharmacy department shall maintain on the premises at all times a sufficient variety and supply of medicinal chemicals and preparations which are necessary to compound and dispense commonly prescribed medications in accordance with the usual needs of the community.

(5) A pharmacy or pharmacy department shall have a reasonably-sized sign affixed to the main entrance of the business or otherwise installed in an easily observable area outside the premises, identifying the presence of a pharmacy or pharmacy department.

(6) A pharmacy or pharmacy department shall conform to the following security requirements: (a) All controlled substances in Schedules II through V shall be stored within the prescription area; (b) controlled substances in Schedule VI shall be stored within the prescription area or in the clean room if the clean room is directly adjacent to the prescription area; (c) controlled substances in Schedules II, III, IV, and V shall be stored in a securely locked and substantially constructed cabinet, or dispersed in the prescription-drug storage area throughout the stock of Schedule VI controlled substances in such a manner as to obstruct the theft or diversion of these controlled substances; (d) there shall be a separate working alarm for the pharmacy or pharmacy department which shall be activated when the pharmacy or pharmacy department is closed; (e) a pharmacy department must be secured by a floor to ceiling barrier, securely locked and separately alarmed at all times when the pharmacy department is closed; (f) the pharmacist Manager of Record and the pharmacist on duty shall be responsible for pharmacy security and shall control access to the prescription area; (g) all drug order deliveries containing controlled substances shall be delivered directly to the pharmacy or pharmacy department or to a secured area if the pharmacy is closed, and the security of those controlled substances is the responsibility of the pharmacist Manager of Record; and (h) each pharmacy or pharmacy department shall comply with all other security requirements which the Board may deem necessary for the protection of the public.

2/1/13 247 CMR - 31 The text of the regulations published in the electronic version of the Massachusetts Register is unofficial and for informational purposes only. The official version is the printed copy which is available from the State Bookstore at http://www.sec.state.ma.us/spr/sprcat/catidx.htm. 247 CMR: BOARD OF REGISTRATION IN PHARMACY

6.02: continued

(7) A pharmacy or a pharmacy department shall conspicuously display, in legible letters not less than one inch high, over, on or adjacent to the main entrance of the pharmacy or pharmacy department, the name of the pharmacist Manager of Record who is responsible for the management and operation of the pharmacy or pharmacy department.

(8) A pharmacy or pharmacy department shall meet the following requirements concerning the posting of hours of operation: (a) The hours of operation shall be prominently posted at all consumer entrances to the pharmacy and, in the case of a pharmacy department, the hours shall also be posted at all consumer entrances to the retail store and at the pharmacy department; (b) if the hours of operation of a pharmacy department, subject to the requirements of 247 CMR 6.02(6)(e) and (10), are different from those of the retail store in which it is located, all advertising referring to the pharmacy department shall clearly specify the pharmacy department's hours of operation; and (c) if the hours of operation of a pharmacy's prescription area, subject to the requirements of 247 CMR 6.02(10), are different from the hours of operation for its non-prescription business, all advertising for the pharmacy shall clearly specify the hours of operation of the pharmacy's prescription area.

(9) A pharmacy or pharmacy department shall meet the following requirements concerning registered pharmacists on duty and shall be present at all times when non-pharmacist personal have unrestricted access to the pharmacy or pharmacy department: (a) A registered pharmacist shall be on duty and on the pharmacy premises at all times the pharmacy or pharmacy department is open for business and shall be present at all times when non-pharmacist personal have unrestricted access to the pharmacy or pharmacy department; (b) each registered pharmacist who is a full-time employee of the pharmacy shall have readily available, or displayed in a conspicuous place, his or her certificate of registration to practice pharmacy and the original or a copy of, his or her current wallet registration card; and (c) a registered pharmacist shall not remain on duty for more than 12 hours per day.

(10) A pharmacy or pharmacy department shall report a theft or loss of a significant amount of controlled substances by submitting to the Board a copy of " Report of Theft or Loss of Controlled Substance" (DEA BND Form 106), within seven days of such theft or significant loss and, where applicable, shall comply with the reporting requirements of the DEA, the Department and the state and local police.

6.03: Requirements for Reporting to the Board a Change in the Management, Operation and/or Ownership of a Pharmacy or Pharmacy Department

(1) Whenever there is a change in the pharmacist Manager of Record of a pharmacy or pharmacy department, an application for a change in pharmacist Manager of Record shall be obtained from and promptly submitted to the Board. A completed application shall be fully and properly completed and signed, under the penalties of perjury, by a duly authorized representative of the pharmacy or pharmacy department and include; (a) a sworn statement confirming that a complete inventory of controlled substances in Schedules II, III, IV and V signed by the outgoing pharmacist Manager of Record and the incoming pharmacist Manager of Record has been taken and filed with the pharmacy’s controlled substance records. In the event the outgoing pharmacist Manager of Record is unavailable due to death, serious illness, or termination for inappropriate handling of controlled substances, a staff pharmacist may be authorized to sign the inventory, provided the Board is notified at the time the application is submitted why the staff pharmacist is signing the inventory; (b) an application for a certificate of fitness, if applicable; (c) the pharmacy permit and, if applicable, the pharmacy or pharmacy department's certificate of fitness; (d) required fee(s); and (e) any additional information as determined by the Board.

1/4/05 247 CMR - 32 The text of the regulations published in the electronic version of the Massachusetts Register is unofficial and for informational purposes only. The official version is the printed copy which is available from the State Bookstore at http://www.sec.state.ma.us/spr/sprcat/catidx.htm. 247 CMR: BOARD OF REGISTRATION IN PHARMACY

6.09: continued

(2) Within ten days of the closure of a pharmacy or pharmacy department, the following shall be completed by the pharmacy or pharmacy department: (a) the pharmacy permit shall be returned to the Board; (b) the pharmacy controlled substance registration shall be returned to the Board; (c) the pharmacy certificate of fitness, if issued, shall be returned to the Board; and (d) the Board shall be notified that all controlled substances have been disposed of in accordance with federal regulations at 21 CFR 1307.21.

6.10: Distribution of Controlled Substances Upon Discontinuance or Transfer of Business of a Pharmacy or Pharmacy Department

(1) Any person who intends to transfer controlled substances in Schedules II through VI from one pharmacy or pharmacy department to another pharmacy or pharmacy department within the Commonwealth shall officially notify the Board in writing, by certified mail at least 14 days before the intended transfer, unless otherwise authorized by the Board, and shall provide the Board with the following information: (a) The name, address and telephone number of the transferor pharmacy or pharmacy department; (b) the name, address and telephone number of the transferee pharmacy or pharmacy department. (c) the pharmacy permit number of the transferor pharmacy or pharmacy department; (d) the pharmacy permit number of the transferee pharmacy or pharmacy department; (e) the pharmacy controlled substance registration number of the transferor pharmacy or pharmacy department; (f) the pharmacy controlled substance registration number of the transferee pharmacy or pharmacy department; (g) the name and pharmacist registration number of the Manager of Record of the transferor pharmacy or pharmacy department; (h) the name and pharmacist registration number of the Manager of Record of the transferee pharmacy or pharmacy department; (i) the date on which the transfer of the controlled substances will take place; and (j) the intended security procedures for transfer of the controlled substances.

(2) After proper notification, the transfer of controlled substances may occur provided the following procedures are adhered to: (a) On the date of the transfer, a complete inventory of all controlled substances in Schedules II through V shall be taken in accordance with federal and state law; (b) said inventory shall be signed by the pharmacist Manager of Record of the transferor pharmacy or pharmacy department and the pharmacist Manager of Record of the transferee pharmacy or pharmacy department. In the event that either pharmacist Manager of Record is unavailable due to death, serious illness, or termination for inappropriate handling of controlled substances, a staff pharmacist may be authorized to sign the inventory, provided the Board is notified at the time the application is submitted as to why the staff pharmacist is signing the inventory; (c) both the transferor and transferee pharmacy or pharmacy department shall maintain a copy of the inventory for two years or as otherwise required by law; (d) a copy of said inventory shall be filed with the Board within ten days of the transfer; (e) the transferee pharmacy or pharmacy department shall receive all required controlled substance and controlled substance inventory records on the date of the transfer and maintain those records for two years; and (f) the transferor pharmacy or pharmacy department shall not possess any controlled substances after the date of transfer.

6.11: Inspections of Pharmacies and Pharmacy Departments

The Board or its designees may visit a pharmacy or pharmacy department at any time without prior notice and inspect it, its staff, activities, and records to determine compliance with state law and 247 CMR 2.00 et seq. The Board may also inspect pharmacies and pharmacy department premises pursuant to 247 CMR 11.12.

6/29/07 247 CMR - 37 The text of the regulations published in the electronic version of the Massachusetts Register is unofficial and for informational purposes only. The official version is the printed copy which is available from the State Bookstore at http://www.sec.state.ma.us/spr/sprcat/catidx.htm. 247 CMR: BOARD OF REGISTRATION IN PHARMACY

6.12: Deficiency Statements

After every Board inspection in which any violation of 247 CMR 2.00 et seq. is observed, the Board or its designees shall prepare a deficiency statement citing every violation observed, a copy of which shall be sent to the pharmacy or pharmacy department.

6.13: Plans of Correction

A pharmacy or pharmacy department shall submit to the Board a written plan of correction of violations cited in a deficiency statement prepared pursuant to 247 CMR 6.12 within 15 business days after the deficiency statement is sent. Every plan of correction shall set forth, with respect to each deficiency, the specific corrective step(s) to be taken, a timetable for such steps, and the date by which compliance with the relevant 247 CMR section will be achieved. The timetable and the compliance dates shall be consistent with achievement of compliance in the most expeditious manner possible. A plan of correction which does not meet the requirements of the relevant 247 CMR section shall be considered unacceptable by the Board and returned to the pharmacy or pharmacy department.

6.14: Duty to Report Certain Improper Drug Dispensing to the Board

Effective January 1, 2010, a pharmacy licensed by the Board is required to report to the Board any improper dispensing of a prescription drug that results in serious injury or death, as defined by the Board, as soon as is reasonably and practicably possible but not later than 15 business days after discovery or being informed of such improper dispensing. The duty to report to the Board any improper dispensing of a prescription drug that results in serious injury or death, pursuant to M.G.L. c. 112, § 39D and 247 CMR 6.14(2), shall be in addition to the Continuous Quality Improvement (CQI) Program requirements of 247 CMR 15.00. Only those events of improper dispensing of a prescription drug that result in serious injury or death are required to be reported to the Board, in accordance with M.G.L. c. 112, § 39D and 247 CMR 6.14(2).

(1) Definitions. For purposes of reporting to the Board, as required by M.G.L. c. 112, § 39D: (a) Improper Dispensing of a Prescription Drug shall mean the incorrect dispensing of a prescribed medication that is received by a patient, as more particularly described in 247 CMR 15.01: Quality-related Event or QRE. (b) Pharmacy, as referenced in 247 CMR 6.14, shall mean a pharmacy, or a group of pharmacies under common ownership and control of one entity, licensed by the Board pursuant to M.G.L. c. 112. (c) Serious Injury shall mean an injury that is life threatening, results in serious disability or death, or requires a patient to undergo significant additional treatment measures. (d) Serious Disability shall include, but is not limited to, injuries requiring major intervention and loss, or substantial limitation, of bodily function lasting greater than seven days (e.g. bodily function related to breathing, dressing/undressing; drinking; eating; eliminating waste products; getting into and out of bed, chair, etc.; hearing; seeing; sitting; sleeping or walking).

(2) Reporting Responsibility. Effective January 1, 2010, a pharmacy shall file a report with the Board of the improper dispensing of a prescription drug that results in serious injury or death, on a form to be provided by the Board, within 15 business days of the pharmacy discovering or being informed of such improper dispensing. A pharmacy shall provide all records relating to such improper dispensing to the Board upon request.

(3) Records Retention. The pharmacy shall retain all records relating to the improper dispensing of a prescription drug that results in serious injury or death which is required to be reported to the Board, in accordance with the requirements of M.G.L. c. 112, § 39D and 247 CMR 6.14(2), for a minimum period of two years from the date the report is filed with the Board.

2/1/13 247 CMR - 38 The text of the regulations published in the electronic version of the Massachusetts Register is unofficial and for informational purposes only. The official version is the printed copy which is available from the State Bookstore at http://www.sec.state.ma.us/spr/sprcat/catidx.htm. 247 CMR: BOARD OF REGISTRATION IN PHARMACY

6.15: Duty to Report Certain Factors of Pharmacy Operations

(1) Definitions. (a) Abnormal Results means results of viable and nonviable testing, such as for environmental contaminants and potency, that are not within acceptable United States Pharmacopeia General Chapter 797 standards or criteria. (b) Accreditation means a process by which a professional association or non-governmental agency grants recognition to a pharmacy for demonstrated ability to meet certain pre-defined criteria. (c) Disciplinary actions means actions including, but not limited to revocation, suspension, probation, censure, reprimand, or restriction of the license to operate a pharmacy or practice pharmacy, denial of application for renewal, denial or restriction of privileges or termination from Medicare or Medicaid programs including any adverse actions or fines imposed by a state or federal agency. (d) Federal agency means any U.S. Government agency that has regulatory purview over the clinical practice of pharmacy or of pharmacy operations, including, but not limited to, all agencies in the U.S. Department of Health and Human Services, the U.S. Occupational Safety and Health Administration, and the U.S. Department of Justice. (e) State agency means any U.S. State or Territory that licenses or otherwise regulates pharmacies or pharmacist practice. (f) Sterile compounding means the preparation, mixing, assembling, packaging, and labeling of a drug or device that is required to be prepared in accordance with United States Pharmacopeia General Chapter 797 and dispensed pursuant to a valid prescription as defined by 247 CMR 2.00.

(2) Every pharmacy licensed pursuant to M.G.L. c. 112, § 39, and pharmacist licensed or registered pursuant to M.G.L. c. 112, § 24, shall report to the Board within seven business days of receipt, in a manner and format determined by the Board, all non-routine notices, correspondence, and disciplinary actions as defined in 247 CMR 6.15.

(3) Every pharmacy licensed pursuant to M.G.L. c. 112, § 39, and pharmacist licensed or registered pursuant to M.G.L. c. 112, § 24, shall report to the Board any adverse change in status of accreditation, including but not limited to withdrawal, discontinuance, termination, revocation, suspension, probation, or warning. All such reports shall be made within seven business days of an action taken by the accrediting agency, and in a manner determined by the Board.

(4) Every pharmacy licensed pursuant to M.G.L. c. 112, § 39, and pharmacist licensed or registered pursuant to M.G.L. c. 112, § 24, shall provide the Board with responsive documents sent from a registrant or licensee to a state or federal agency with respect to reports or responses submitted pursuant to 247 CMR 6.15(2) and (3). All such materials shall be provided to the board within seven business days of response to the aforementioned state or federal agency.

(5) Every pharmacy licensed pursuant to M.G.L. c. 112, § 39, that performs central intravenous admixture services (CIVAS), or engages in sterile compounding, shall report to the Board every six months, or upon request by the Board, at a minimum, the following information: (a) total number and type of prescriptions dispensed, distribution data identifying the states in which the prescriptions were distributed, status of any non-resident licenses issued by other states, hood certifications required by 247 CMR 6.01(5)(c)5., and all International Organization for Standardization (ISO) certifications in the pharmacy, status of CIVAS approval(s) where applicable, and any other information required by the Board. (b) All such reports shall be accurate and comply with the Board's reporting requirements. (c) All reports shall be accompanied by an affidavit attesting compliance with all laws and regulations pertinent to sterile compounding and United States Pharmacopeia General Chapter 797. This attestation shall be made under pains and penalties of perjury, and include attestation to the following "this registrant/licensee only dispenses medication pursuant to a valid prescription as defined in M.G.L. c. 94C for a single patient, regardless of whether the medication is prepared for a Massachusetts or out-of-state patient."

2/1/13 247 CMR - 38.1 The text of the regulations published in the electronic version of the Massachusetts Register is unofficial and for informational purposes only. The official version is the printed copy which is available from the State Bookstore at http://www.sec.state.ma.us/spr/sprcat/catidx.htm. 247 CMR: BOARD OF REGISTRATION IN PHARMACY

6.15: continued

(6) Every pharmacy engaged in sterile compounding and licensed pursuant to M.G.L. c. 112, § 39 shall report within seven business days of identification all errors relating to the preparation of medications in that pharmacy inconsistent with United States Pharmacopeia General Chapter 797 standards or criteria for factors including but not limited to pyrogenicity, stability, improper composition, mislabeling, or sterility.

(7) Every pharmacy licensed pursuant to M.G.L. c. 112, § 39 shall report within seven business days all abnormal results, including failure of certification as required pursuant to 247 CMR 6.01(5)(c), and identification of environmental contaminants or improper potency in that pharmacy inconsistent with United States Pharmacopeia General Chapter 797 standards or criteria.

(8) Failure to comply with reporting requirements described in 247 CMR 6.15(2) through (7) or to cooperate fully in the Board's investigation of any such report to the Board shall be grounds for disciplinary action pursuant to 247 CMR 10.03: Grounds for Discipline(1)(q).

REGULATORY AUTHORITY

247 CMR 6.00: M.G.L. c. 112, §§ 42A and 30; c. 138, §§ 29 through 30G.

2/1/13 247 CMR - 38.2 The text of the regulations published in the electronic version of the Massachusetts Register is unofficial and for informational purposes only. The official version is the printed copy which is available from the State Bookstore at http://www.sec.state.ma.us/spr/sprcat/catidx.htm. Docket # 81

THE COMMONWEALTH OF MASSACHUSETTS William Francis Galvin Secretary of the Commonwealth

Regulation Filing To be completed by filing agency

CHAPTER NUMBER: 247 CMR 10.00

CHAPTER TITLE: Disciplinary Proceedings

AGENCY: Board of Registration in Pharmacy

SUMMARY OF REGULATION: State the general requirements and purposes of this regulation. Revises 247 CMR 10.00 by inserting: (a) definition of "conviction" (247 CMR 10.02); (b) additional grounds for discipline of an individual or entity licensed by the Board of Registration in Pharmacy (247 CMR 10.03(1)); (c) sections regarding summary cease and desist (247 CMR 10:06(8)) and quarantine (247 CMR 10.06(9)) notices that may be imposed by the Board of Registration in Pharmacy or Board President prior to hearing; and (d) sections regarding summary cease and desist and quarantine notice process.

REGULATORY AUTHORITY: M.G.L. c. 112, s. 42A

AGENCY CONTACT: Heather A. Engman PHONE: 617-973-0992

ADDRESS: DPH/DHPL/Board of Registration in Pharmacy, 239 Causeway Street, 5th Floor, Boston, MA 02114 Compliance with M.G.L. c. 30A

EMERGENCY ADOPTION - if this regulation is adopted as an emergency, state the nature of the emergency. This regulation was initially adopted as an emergency regulation on November 1, 2012. Immediate implementation of the duty of an individual or entity licensed by the Board to report certain information to the Board of Registration in Pharmacy and the process of imposing cease and desist and/or quarantine notices was necessary to protect the public health, safety, and welfare. PRIOR NOTIFICATION AND/OR APPROVAL - If prior notification to and/or approval of the Governor, Legislature or others was required, list each notification, and/or approval and date, including notice to the Local Government Advisory Commission. Notification to Executive Office of Communities and Development and Massachusetts Municipal Association sent on 11/2/12.

Date of public hearing or comment period: December 4, 2012

For the first five years:

No fiscal effect: No fiscal effect.

Date amended small business impact statement was filed: January 14, 2013

CODE OF MASSACHUSETTS REGULATIONS INDEX - List key subjects that are relevant to this regulation: Pharmacist Pharmacy Pharmacy Department

PROMULGATION - State the action taken by this regulation and its effect on existing provisions of the Code of Massachusetts Regulations (CMR) or repeal, replace or amend. List by CMR number: Amends 247 CMR sections 10.02, 10.03, and 10.06; adds new sections 247 CMR 10.08.

ATTESTATION - The regulation described herein and attached hereto is a true copy of the regulation adopted by this agency. ATTEST:

SIGNATURE: SIGNATURE ON FILE DATE: Jan 17 2013

Publication - To be completed by the Regulations Division

MASSACHUSETTS REGISTER NUMBER: 1227 DATE: 02/01/2013

EFFECTIVE DATE: 02/01/2013

CODE OF MASSACHUSETTS REGULATIONS Remove these pages: Insert these pages: 55 - 56.2 55 - 56.2

01/17/2013 mrs

247 CMR 10.00: DISCIPLINARY PROCEEDINGS

Section

10.01: Purpose 10.02: Definitions 10.03: Grounds for Discipline 10.04: Investigative Conference 10.05: Disposition by the Board 10.06: Disciplinary Action 10.07: Suspension Prior to Hearing 10.08: Summary Cease and Desist and Quarantine Notice

10.01: Purpose

The purpose of 247 CMR 10.00 is to outline the procedures used by the Board in order to handle complaints received against Board registrants or licensees. The Board may take disciplinary action against a registered pharmacist, pharmacy technician, pharmacy, pharmacy department, wholesale license, and/or controlled substance registration issued by the Board.

10.02: Definitions

Adjudicatory Hearing means a formal administrative hearing held by the Board conducted to determine the truth and validity of complaints filed against a registrant or licensee. Such hearing is held pursuant to M.G.L. c. 30A and 801 CMR 1.01: Formal Rules.

Complaint means a communication filed with the Board or the Division of Health Professions Licensure which the Board determines, after investigation, merits further consideration or action.

Conviction shall include any guilty verdict or finding of guilt and any admission to or finding of sufficient facts to warrant a finding of guilt, regardless of adjudication, a continuance without a finding, and any plea of guilty or nolo contendere, of or to a crime in any jurisdiction, which has been accepted by the court, whether or not a sentence has been imposed. A conviction of any person licensed or registered by the Board shall be conclusive evidence of the commission of that crime in any disciplinary proceeding against such person based upon the conviction.

Investigative Conference means an informal discussion relating to a complaint held with the Board.

Order to Show Cause means a document served by the Board upon a registrant ordering the registrant or licensee to appear before the Board for a formal adjudicatory hearing.

10.03: Grounds for Discipline

(1) The Board may impose disciplinary action against an individual or entity licensed or registered by the Board, on one or more of the grounds for discipline listed in M.G.L. c. 112, § 61 or one or more of the following grounds: (a) Violating any of the duties and standards set out in Board regulations (247 CMR 2.00: Definitions) or any rule or written policy adopted by the Board; (b) Violating any provision of M.G.L. c. 112, §§ 24 through 42A or any provision of state or federal statutes or rules or regulations promulgated thereunder related to the practice of the profession; (c) Failing to submit an acceptable plan of correction pursuant to 247 CMR 6.13: Plans of Correction; (d) Failing to remedy or correct a violation cited in a deficiency statement by the date specified in the plan of correction submitted in accordance with 247 CMR 6.13: Plans of Correction, as accepted or modified by the Board, unless the pharmacy or pharmacy department demonstrates to the satisfaction of the Board that such failure was not due to any neglect of duty and occurred despite his/her good faith attempt to remedy or correct the violations(s) by the specified time; (e) Engaging in misconduct in the practice of the profession; (f) Engaging in conduct beyond the authorized scope of a pharmacist, pharmacy intern or pharmacy technician;

2/1/13 247 CMR - 55 The text of the regulations published in the electronic version of the Massachusetts Register is unofficial and for informational purposes only. The official version is the printed copy which is available from the State Bookstore at http://www.sec.state.ma.us/spr/sprcat/catidx.htm. 247 CMR: BOARD OF REGISTRATION IN PHARMACY

10.03: continued

(g) Practicing the profession while the ability to practice is impaired by illness, use of alcohol, drugs, chemicals, or any other type of substance, or as a result of any mental or physical condition; (h) Engaging in abuse or illegal use of prescription drugs or controlled substances; (i) Continuing to practice the profession after a registration is lapsed, suspended or revoked; (j) Violating the terms of a Consent Agreement, Final Decision and Order, Surrender Agreement or any other order issued by or agreement entered into with the Board; (k) Engaging in conduct that has the capacity or potential to place the public health, safety or welfare at risk; (l) Engaging in conduct that has the capacity or potential to deceive or defraud; (m) Knowingly permitting, aiding or abetting an unlicensed person to perform activities requiring a license or registration; (n) Being convicted of any crime, entering a plea of guilty to any crime, entering a plea of nolo contendere to any crime, or admitting to sufficient facts to warrant a finding of guilty of any crime; (o) Fraudulently procuring a license or registration or its renewal; (p) Providing false information on an application for a license or registration or its renewal; (q) Failing without cause, to cooperate with any request by the Board to appear before it or to provide requested information; failing to respond to a Board subpoena or failing to furnish the Board, its investigators or representatives with records, documents, information or testimony to which the Board is legally entitled; (r) Engaging in conduct that demonstrates a lack of good moral character; (s) Cheating on or attempting to compromise the integrity of any licensing or registration examination; (t) Having been disciplined in another jurisdiction in any way for reasons substantially the same as those set forth in 247 CMR 10.03; (u) Engaging in conduct which undermines public confidence in the integrity of the profession; (v) Committing an act that violates recognized standards of pharmacy practice; (w) Failing to comply with recognized ethical standards of the profession, including, but not limited to, the standards of practice of pharmacists, pharmacy interns, pharmacies and pharmacy departments set forth in 247 CMR 9.01: Code of Conduct for Registered Pharmacists, Pharmacies and Pharmacy Departments; (x) Violation of M.G.L. c. 94C or any rules or regulations promulgated thereunder; (y) Failing to report or failing to accurately report to the Board within seven business days, in a manner and format determined by the Board, discipline (247 CMR 10.06) on the basis of actions listed in 247 CMR 10.03(1); (z) Failing to report to the Board, in a manner and format determined by the Board, within seven business days, any final action (including license surrender or resignation) regarding a registrant or licensee, including any against any other health care related professional registration or license held by a registrant or licensee, by any other governmental authority in this state or another jurisdiction; (aa) Failing to report to the Board, in writing, within 30 days, any pending criminal charge or conviction, as defined in 247 CMR 10.02, of a registrant or licensee, in Massachusetts or any other jurisdiction; and (bb) Failure to comply with reporting requirements described in 247 CMR 6.15: Duty to Report Certain Factors of Pharmacy Operations(2) through (7) or to cooperate fully in the Board's investigation of any such report.

(2) Nothing in 247 CMR 10.03 shall limit the Board's adoption of policies and grounds for discipline through adjudication as well as through rulemaking.

10.04: Investigative Conference

To facilitate disposition of any complaint, the Board may schedule an investigative conference at any time prior to the commencement of a formal adjudicatory proceeding. The Board shall give timely notice of the conference, and this notice shall include a general statement of the nature of the issues to be discussed.

2/1/13 247 CMR - 56 The text of the regulations published in the electronic version of the Massachusetts Register is unofficial and for informational purposes only. The official version is the printed copy which is available from the State Bookstore at http://www.sec.state.ma.us/spr/sprcat/catidx.htm. 247 CMR: BOARD OF REGISTRATION IN PHARMACY

10.05: Disposition by the Board

After receipt of a complaint and all related investigative materials, the Board may schedule an investigative conference or may schedule a formal adjudicatory hearing pursuant to M.G.L. c. 30A and 801 CMR 1.01: Formal Rules if it determines that one is required.

10.06: Disciplinary Action

Actions which may be taken by the Board are:

(1) Dismissal of the complaint.

(2) Advisory Letter. An official written document retained in the Board’s files delineating the Board’s concerns with the registrant's or licensee’s professional practice. An advisory letter does not constitute formal disciplinary action.

(3) Reprimand or Censure of the Registrant or Licensee. A reprimand constitutes formal disciplinary action. A censure is a severe reprimand.

(4) Probation. Probation constitutes disciplinary action against the registrant or licensee and consists of a period of time during which the registrant or licensee may practice under conditions imposed by the Board pursuant to a formal adjudicatory hearing or consent agreement.

(5) Suspension/Revocation of Personal Registration, Pharmacy Permit, License or Controlled Substances Registration. Suspension or revocation of a personal registration, pharmacy permit, license or controlled substance registration may be imposed pursuant to a decision and order of the Board following a formal adjudicatory hearing or following the execution of a consent agreement.

(6) Consent Agreement. A resolution of a complaint agreed upon by the Board and the registrant or licensee which may contain conditions placed by the Board on the registrant's or licensee’s professional conduct and practice and which may include the voluntary suspension or surrender of a personal registration, pharmacy permit, license or controlled substance registration. The voluntary surrender of a personal registration, pharmacy permit, license, or controlled substance registration, may be permanent or for a fixed period of time. The voluntary surrender agreement shall: (a) be in writing and be signed by the registrant or the licensee and the Board; (b) recite the facts upon which the agreement is based and shall include, but not be limited to provisions addressing reinstatement and any conditions the Board may elect to impose; (c) state that the registrant or licensee realizes that the voluntary surrender of his or her personal registration, pharmacy permit, license or controlled substance registration, is an act which deprives him or her of all privileges of registration and is not subject to judicial review; and (d) be placed in the registrant's or licensee’s Board file as part of the registrant's or licensee’s permanent Board records.

(7) Disciplinary Action Against a Massachusetts Registrant or Licensee Taken in Another State. Disciplinary action taken against a Massachusetts registrant or licensee by another state or jurisdiction in which that person is also registered or licensed may be the basis for initiation by the Board of disciplinary action against the Massachusetts registrant or licensee provided that the conduct disciplined in another state or jurisdiction constitutes a violation of Massachusetts law.

(8) Summary Cease and Desist Notice. A summary cease and desist notice may be imposed by the Board or Board President prior to hearing in order to stop or restrict operations by a registrant or licensee to immediately protect the public health, safety or welfare. The Board or Board President may rescind or amend a summary cease and desist notice.

(9) Summary Quarantine Notice. A summary quarantine notice may be imposed by the Board or Board President prior to hearing in order to prevent the use of medications prepared by or in possession of a registrant or licensee to immediately protect the public health, safety or welfare. The Board or Board President may rescind or amend a summary quarantine notice.

2/1/13 247 CMR - 56.1 The text of the regulations published in the electronic version of the Massachusetts Register is unofficial and for informational purposes only. The official version is the printed copy which is available from the State Bookstore at http://www.sec.state.ma.us/spr/sprcat/catidx.htm. 247 CMR: BOARD OF REGISTRATION IN PHARMACY

10.07: Suspension Prior to Hearing

If, based upon affidavits or other documentary evidence, the Board determines that a licensee is an immediate or serious threat to the public health, safety, or welfare, the Board may suspend or refuse to renew a license pending a final hearing on the merits of the allegations regarding the licensee. A hearing limited to the determination of the necessity of the summary action shall be afforded the licensee within seven days of the Board’s action.

10.08: Summary Cease and Desist and Quarantine Notice

(1) If, based upon affidavits or other evidence, the Board or Board President determines that a registrant or licensee or the products prepared by a registrant or licensee are an immediate or serious threat to the public health, safety, or welfare, the Board or Board President may: (a) issue a Cease and Desist Notice and/or Quarantine Notice, requiring non-disciplinary cessation or restriction of any and all pharmacy operations, and prohibiting the use of medications prepared by or in possession of a pharmacy; or (b) issue a Cease and Desist Notice placing non-disciplinary restrictions on a Board registrant or licensee, to the extent necessary, to avert a continued threat, pending final investigation results.

(2) Requirements of the Cease and Desist Notice and/or Quarantine Notice shall remain in effect until the Board or Board President rescinds or amends such requirements or until such time as the Board takes final action on any related pending complaint and the Board issues a final decision.

(3) A hearing limited to the determination of the necessity of Notices issued pursuant to 247 CMR 10.06(8) and (9), or 247 CMR 10.08(1) shall be afforded the registrant or licensee within 15 business days of the Board or Board President's action.

REGULATORY AUTHORITY

247 CMR 10.00: 801 CMR 1.01; M.G.L. c. 112, §§ 24 and 42A; c. 30A.

2/1/13 247 CMR - 56.2 The text of the regulations published in the electronic version of the Massachusetts Register is unofficial and for informational purposes only. The official version is the printed copy which is available from the State Bookstore at http://www.sec.state.ma.us/spr/sprcat/catidx.htm. Docket # 73

THE COMMONWEALTH OF MASSACHUSETTS William Francis Galvin Secretary of the Commonwealth

Regulation Filing To be completed by filing agency

CHAPTER NUMBER: 264 CMR 1.00

CHAPTER TITLE: Disciplinary Proceedings

AGENCY: Board of Registration of Real Estate Appraisers

SUMMARY OF REGULATION: State the general requirements and purposes of this regulation. This regulation is being amended to adopt the 2012-2013 edition of the Uniform Standards of Professional Appraisal Practice ("USPAP") that the Board must enforce in accordance with the Appraisal Foundation, the Board's federal oversight authority.

REGULATORY AUTHORITY: G.L. c. 112, s. 173 through 195, G.L. c. 13, s. 91

AGENCY CONTACT: Charles Kilb PHONE: 617-727-2707

ADDRESS: Division of Professional Licensure, 1000 Washington St., Boston, MA 02118

Compliance with M.G.L. c. 30A

EMERGENCY ADOPTION - if this regulation is adopted as an emergency, state the nature of the emergency.

PRIOR NOTIFICATION AND/OR APPROVAL - If prior notification to and/or approval of the Governor, Legislature or others was required, list each notification, and/or approval and date, including notice to the Local Government Advisory Commission. Executive Order 485 Approval - 10/9/12 pre hearing, 12/26/12 post hearing Local Government Advisory Commission - 10/11/12 Notice in Mass. Register - 11/9/12; Boston Globe, Springfield Republican - 11/7/12

Date of public hearing or comment period: November 29, 2012

For the first five years: No fiscal impact anticipated

No fiscal effect: No fiscal impact anticipated

Date amended small business impact statement was filed: January 9, 2013

CODE OF MASSACHUSETTS REGULATIONS INDEX - List key subjects that are relevant to this regulation: Real Estate Appraisers, Disciplinary Proceedings, Uniform Standards of Professional Appraisal Practice, USPAP.

ATTESTATION - The regulation described herein and attached hereto is a true copy of the regulation adopted by this agency. ATTEST:

SIGNATURE: SIGNATURE ON FILE DATE: Jan 10 2013

Publication - To be completed by the Regulations Division

MASSACHUSETTS REGISTER NUMBER: 1227 DATE: 02/01/2013

EFFECTIVE DATE: 02/01/2013

CODE OF MASSACHUSETTS REGULATIONS Remove these pages: Insert these pages: 1 - 4 1 - 4

01/10/2013 cm

Table of Contents Page

264 CMR 1.00: DISCIPLINARY PROCEEDINGS 3

Section 1.01: Preface 3 Section 1.02: Definitions 3 Section 1.03: General Provisions 3 Section 1.04: Dispositions of Complaints 5 Section 1.05: Adjudicatory Hearing Procedures 6 Section 1.06: Final Decision and Order and Miscellaneous Provisions 6

264 CMR 2.00: GENERAL PROVISIONS 9

Section 2.01: Purpose and Authority 9 Section 2.02: Gender of Pronouns 9 Section 2.03: Definitions 9

264 CMR 3.00: APPLICATION, EXAMINATION AND REGISTRATION PROCEDURES: APPRAISAL TRAINEE, STATE-LICENSED APPRAISER, STATE-CERTIFIED RESIDENTIAL APPRAISER OR STATE-CERTIFIED GENERAL APPRAISER 15

Section 3.01: Application Procedures 15 Section 3.02: Examination Procedures 16 Section 3.03: Procedures for Receipt of Initial License or Certification 17 Section 3.04: Federal Appraiser Registry 17

264 CMR 4.00: RENEWAL PROCEDURES AND CONTINUING EDUCATION REQUIREMENTS 19

Section 4.01: General Renewal Procedures 19 Section 4.02: Renewal After Expiration of License or Certificate 20 Section 4.03: Continuing Education Requirement Deferrals 20

264 CMR 5.00: LICENSURE/CERTIFICATION REQUIREMENTS 21

Section 5.01: General Requirements 21 Section 5.02: Requirements for Real Estate Appraisal Trainee Licensure 21 Section 5.03: Requirements for State-licensed Real Estate Appraisers 21 Section 5.04: Requirements for State-certified Residential Real Estate Appraisers 22 Section 5.05: Requirements for State-certified General Real Estate Appraisers 22 Section 5.06: Experience Criteria 23 Section 5.07: Experience Audits 24 Section 5.08: Primary Education Criteria 24 Section 5.09: Required Core Curricula 24.1

264 CMR 6.00: PRACTICE OF REAL ESTATE APPRAISAL 25

Section 6.01: Scope of Practice 25 Section 6.02: Mandatory License Identification 26.1 Section 6.03: Use of Titles in Firm Advertising 26.2 Section 6.04: Records Retention 26.2

264 CMR 7.00: SPECIAL CLASSIFICATION OF LICENSE/CERTIFICATE 27

(Section 7.01: Transitional Licenses: Repealed) 27 Section 7.02: Temporary Registration 27

2/1/13 264 CMR - 1 The text of the regulations published in the electronic version of the Massachusetts Register is unofficial and for informational purposes only. The official version is the printed copy which is available from the State Bookstore at http://www.sec.state.ma.us/spr/sprcat/catidx.htm. 264 CMR: BOARD OF REGISTRATION OF REAL ESTATE APPRAISERS

Table of Contents Page

264 CMR 8.00: RECIPROCITY FOR STATE-LICENSED/STATE CERTIFIED REAL ESTATE APPRAISERS 29

Section 8.01: Reciprocity/Licensure by Endorsement 29

264 CMR 9.00: COURSE APPROVAL REQUIREMENTS FOR PROVIDERS OF PRIMARY AND CONTINUING EDUCATION 31

Section 9.01: Course Approval by Board 31 Section 9.02: Application for Course Approval 31 Section 9.03: Criteria for Course Approval 32 Section 9.04: Criteria for Instructor Qualification 32 Section 9.05: Primary Education 32 Section 9.06: Continuing Education 33 Section 9.07: Distance Education 33 Section 9.08: Uniform Standards of Professional Appraisal Practice (USPAP) Courses 34 Section 9.09: Approved Courses 34 Section 9.10: Renewal of Course Approval 34

(264 CMR 10.00: RESERVED) 35

264 CMR 11.00: STANDARDS OF PRACTICE AND ETHICS 37

Section 11.01: Standards of Practice and Ethics 37

264 CMR 12.00: BOARD PROCEDURES 39

Section 12.01: Establishment of Subcommittees 39 Section 12.02: Election of Officers 39 Section 12.03: Non-applicability of USPAP to Board-related Appraisal Reviews 39

2/1/13 264 CMR - 2 The text of the regulations published in the electronic version of the Massachusetts Register is unofficial and for informational purposes only. The official version is the printed copy which is available from the State Bookstore at http://www.sec.state.ma.us/spr/sprcat/catidx.htm. 264 CMR: BOARD OF REGISTRATION OF REAL ESTATE APPRAISERS

264 CMR 1.00: DISCIPLINARY PROCEEDINGS

Section

1.01: Preface 1.02: Definitions 1.03: General Provisions 1.04: Dispositions of Complaints 1.05: Adjudicatory Hearing Procedures 1.06: Final Decision and Order and Miscellaneous Provisions

1.01: Preface

264 CMR 1.00 governs the disposition of matters relating to the practice of real estate appraisal by any person applying for, holding or having held a license or certificate issued by the Board of Real Estate Appraisers under M.G.L. c. 112, §§ 173 through 195, and the conduct of adjudicatory hearings by the Board. 264 CMR 1.00 is based on the principle of fundamental fairness to licensees and shall be construed to secure a speedy and just disposition.

1.02: Definitions

Adjudicatory Hearing. A formal administrative hearing conducted pursuant to M.G.L. c. 30A.

Board. The Board of Registration of Real Estate Appraisers.

Complaint. A communication filed with, or by, the Board that charges a licensee with misconduct.

Informal. Not subject to strict procedural or evidentiary rules

Licensee. For the purposes of 264 CMR 1.00, a person holding or having held any type of license or certificate issued pursuant to M.G.L. c. 112, §§ 173 through 195.

Order to Show Cause. A document issued by the Board ordering a licensee to appear before the Board for an adjudicatory proceeding and show cause why the licensee should not be disciplined.

Party. A respondent, prosecutor representing the Board, or intervenor in an adjudicatory proceeding pursuant to 801 CMR 1.01(9): Intervention and Participation.

Presiding Officer. The individual(s) duly designated by the Board to conduct an adjudicatory proceeding, as provided in 801 CMR 1.00: Standard Adjudicatory Rules of Practice and Procedure.

Quorum. Five members of the Board.

Respondent. The licensee named in an Order to Show Cause.

Uniform Standards of Professional Appraisal Practice (USPAP). The 2012-2013 edition, effective January 1, 2012, of the uniform appraisal standards document titled Uniform Standards of Professional Appraisal and Advisory Opinions, including comments and statements, established and published by the Appraisal Standards Board (ASB). Prior to January 1, 2012, the 2010-2011 edition shall remain in effect.

1.03: General Provisions

(1) Communications. All written correspondence should be addressed to and filed with the Board of Registration of Real Estate Appraisers. (a) Disciplinary Proceeding. Communications by parties regarding disciplinary proceedings shall be in writing and directed to Board members as follows: Seven copies to the Chair of the Board, one copy to the Board Counsel, one copy to the hearing officer, and one copy to each party.

2/1/13 264 CMR - 3 The text of the regulations published in the electronic version of the Massachusetts Register is unofficial and for informational purposes only. The official version is the printed copy which is available from the State Bookstore at http://www.sec.state.ma.us/spr/sprcat/catidx.htm. 264 CMR: BOARD OF REGISTRATION OF REAL ESTATE APPRAISERS

1.03: continued

(b) Identification and Signature. All papers filed with the Board in the course of a disciplinary proceeding must contain the name, address, and telephone number of the party making the filing and must be signed by either the party or an authorized representative. (c) Date of Receipt. Communications are deemed received on the date of actual receipt by the Board. (d) Ex Parte Communication with Board Members. No party, or his or her representative(s) shall engage in ex parte communications with individual Board members regarding a disciplinary proceeding.

(2) Service. All papers served must be accompanied by a certificate of service. (a) Service by the Board. The Board shall provide notice of its actions in accordance with the Standard Adjudicatory Rules, set forth in 801 CMR 1.01(4)(b) and (5)(f), or otherwise with reasonable attempts at in-hand service, unless the respondent otherwise has actual notice of the Board’s action. Where 264 CMR 1.00 provides that the Board must notify parties, service may be made by first class mail. (b) Service by the Respondent. When a Presiding Officer has jurisdiction over an adjudicatory proceeding, proper service by the respondent includes filing copies of all papers and exhibits with: 1. the Board, care of its counsel; 2. the presiding officer assigned to the adjudicatory proceeding; and 3. the prosecutor assigned to the adjudicatory proceeding. (c) Notice of Appearance. A notice of appearance on behalf of a respondent shall be deemed an agreement to accept service of any document on behalf of the respondent, including a Final Decision and Order of the Board.

(3) Time. (a) Computation of Time. The Board shall compute time in accordance with 801 CMR 1.01(4)(c). (b) Extension of Time. The Board, in its discretion, may extend any time limit prescribed or allowed by 264 CMR 1.00.

(4) Decisions by the Board: Quorum. Unless 264 CMR 3.00 provides otherwise, a majority of members present and voting at a Board meeting shall make all decisions and the Board shall record its decision in the minutes of its meetings. A quorum is five members of the Board (M.G.L. c. 13, § 92).

(5) Availability of Board Records to the Public. The availability of the Board’s records to the public is governed by the provisions of the Public Records Law as set forth in M.G.L. c. 66, § 10 and M.G.L. c. 4, § 7, clause twenty-sixth.

(6) Public Nature of Board Meetings Under 264 CMR 1.00. (a) All meetings of the Board are open to the public to the extent required by M.G.L. c. 30A, § 11A. (b) As provided by M.G.L. c. 30A, § 11A, a Board meeting held for the purpose of making a decision required in an adjudicatory proceeding is not open to the public.

(7) Public Nature of Evidentiary Hearings. Evidentiary hearings before individual hearing officers are generally open to the public, but the Board may carry out its functions under 264 CMR 1.00 in closed session if either: (a) these functions affect an individual licensee, the licensee requests that the Board function in closed session, and the Board or Presiding Officer determines that functioning in closed session would be consistent with law and in the public interest; or, (b) Sua Sponte, the Board or Presiding Officer determines that functioning in closed session would be consistent with law and in the public interest.

4/8/05 264 CMR - 4 The text of the regulations published in the electronic version of the Massachusetts Register is unofficial and for informational purposes only. The official version is the printed copy which is available from the State Bookstore at http://www.sec.state.ma.us/spr/sprcat/catidx.htm. Docket # 74

THE COMMONWEALTH OF MASSACHUSETTS William Francis Galvin Secretary of the Commonwealth

Regulation Filing To be completed by filing agency

CHAPTER NUMBER: 264 CMR 5.00

CHAPTER TITLE: Licensure/Certification Requirements

AGENCY: Board of Registration of Real Estate Appraisers

SUMMARY OF REGULATION: State the general requirements and purposes of this regulation. This section addresses the education and work experience requirements necessary for licensure. These changes will eliminate the use of certain old education/work experience, will increase education requirements, and will require background checks of applicants per federal requirements.

REGULATORY AUTHORITY: G.L. c. 112, s. 173 through 195, G.L. c. 13, s. 91

AGENCY CONTACT: Charles Kilb PHONE: 617-727-2707

ADDRESS: Division of Professional Licensure, 1000 Washington St., Boston, MA 02118

Compliance with M.G.L. c. 30A

EMERGENCY ADOPTION - if this regulation is adopted as an emergency, state the nature of the emergency.

PRIOR NOTIFICATION AND/OR APPROVAL - If prior notification to and/or approval of the Governor, Legislature or others was required, list each notification, and/or approval and date, including notice to the Local Government Advisory Commission. Executive Order 485 Approval - 10/9/12 pre hearing, 12/26/12 post hearing Local Government Advisory Commission - 10/11/12 Notice in Mass. Register - 11/9/12; Boston Globe, Springfield Republican - 11/7/12

Date of public hearing or comment period: November 29, 2012

For the first five years: Minimal to no fiscal impact anticipated

No fiscal effect: Minimal to no fiscal impact anticipated

Date amended small business impact statement was filed: January 9, 2013

CODE OF MASSACHUSETTS REGULATIONS INDEX - List key subjects that are relevant to this regulation: Real Estate Appraisers, Criteria, Education, Audits.

ATTESTATION - The regulation described herein and attached hereto is a true copy of the regulation adopted by this agency. ATTEST:

SIGNATURE: SIGNATURE ON FILE DATE: Jan 10 2013

Publication - To be completed by the Regulations Division

MASSACHUSETTS REGISTER NUMBER: 1227 DATE: 02/01/2013

EFFECTIVE DATE: 02/01/2013

CODE OF MASSACHUSETTS REGULATIONS Remove these pages: Insert these pages: 21 - 24.2 21 - 24.2

01/10/2013 cm

264 CMR 5.00: LICENSURE/CERTIFICATION REQUIREMENTS

Section

5.01: General Requirements 5.02: Requirements for Real Estate Appraisal Trainee Licensure 5.03: Requirements for State-licensed Real Estate Appraisers 5.04: Requirements for State-certified Residential Real Estate Appraisers 5.05: Requirements for State-certified General Real Estate Appraisers 5.06: Experience Criteria 5.07: Experience Audits 5.08: Primary Education Criteria 5.09: Required Core Curricula

5.01: General Requirements

264 CMR 5.01 does not apply to temporary licenses. Criteria for such levels of licensure are contained in 264 CMR 7.00: Special Classification of License/Certification.

(1) All other applicants for licensure or certification must: (a) demonstrate that he or she is of good moral character with a reputation for honesty, trustworthiness, and integrity; (b) meet the requirements for the level of license or certificate for which he or she is applying, as set forth in 264 CMR 5.01; and (c) effective January 1, 2015, successfully undergo background screening meeting the criteria set out by the Appraiser Qualification Board (AQB) per federal law, 12 U.S.C. 3345(a).

(2) Individuals applying for a license or certificate may be awarded primary education credit for primary education classroom hours previously credited in an application for a different level license or certificate.

(3) Credit awarded in fulfilling continuing education renewal requirements may also be awarded to satisfy primary education requirements when an individual seeks a different level license or certificate than that held, providing the educational offering meets the criteria for primary education.

(4) Regardless of the date of application and in accordance with the Appraiser Qualification Board (AQB) mandates per federal law, 12 U.S.C. 3345(a), all licensure or certification applicants, with the exception of appraisal trainees, credentialed on or after January 1, 2008, shall be subject to new and additional AQB requirements. It shall be the responsibility of each applicant to ensure compliance with any and all AQB criteria in force and effect. This criteria is published by the Appraisal Foundation.

5.02: Requirements for Real Estate Appraisal Trainee Licensure

Each applicant shall complete 75 classroom hours of primary education in real estate appraisal. All courses shall be approved by the Board and shall satisfy the education criteria set forth in 264 CMR 9.00: Course Approval Requirements for Providers of Primary and Continuing Education and 5.09 and the Core Curriculum adopted by the AQB per federal law, 12 U.S.C. 3345(a). Notwithstanding 264 CMR 5.08, all education must be completed within five years of the date of application for a real estate appraisal trainee license. Effective January 1, 2015, applicants must also complete a Board approved course regarding the requirements and responsibilities of trainees and supervisory appraisers which meets the criteria of the AQB per federal law, 12 U.S.C. 3345(a).

5.03: Requirements for State-licensed Real Estate Appraisers

Each applicant shall:

(1) Pass the Massachusetts Examination for State-licensed Real Estate Appraisers or an equivalent examination approved by the Board, within two years from the date of Board approval to take such examination;

2/1/13 264 CMR - 21 The text of the regulations published in the electronic version of the Massachusetts Register is unofficial and for informational purposes only. The official version is the printed copy which is available from the State Bookstore at http://www.sec.state.ma.us/spr/sprcat/catidx.htm. 264 CMR: BOARD OF REGISTRATION OF REAL ESTATE APPRAISERS

5.03: continued

(2) Complete 150 classroom hours of primary education in real estate appraisal education. All courses shall be approved by the Board and satisfy the Education Criteria set forth in 264 CMR 9.00 and 5.09 and the Core Curriculum adopted by the AQB per criteria specified by federal law, 12 U.S.C. 3345(a);

(3) For applicants taking the examination on or after January 1, 2015: Hold an Associate's Degree or higher from an accredited college or university or must have successfully completed 30 semester hours of college-level education from an accredited college or university;

(4) Complete 2,000 hours of real estate appraisal experience over a minimum period of 24 months. Experience must satisfy the Real Estate Appraisal Experience Criteria forth in 264 CMR 5.06; and

(5) Meet the minimum AQB Real Property Appraiser Qualification Criteria and Interpretations as published by the Appraisal Foundation per criteria specified by federal law, 12 U.S.C. 3345(a).

5.04: Requirements for State-certified Residential Real Estate Appraisers

Each applicant shall:

(1) Pass the Massachusetts Examination for State-certified Real Estate Appraisers or an equivalent examination approved by the Board, within two years from the date of Board approval to take such examination;

(2) Complete 200 classroom hours of primary education in real estate appraisal. All courses must be approved by the Board and satisfy the Education Criteria set forth in 264 CMR 5.09 and 9.00: Course Approval Requirements for Providers of Primary and Continuing Education, and the Core Curriculum adopted by the AQB; and

(3) For applicants taking the examination prior to January 1, 2015 (complete applications meeting all other requirements of these regulations must be received by the Board at least 90 days prior to an examination date to ensure meeting this deadline): Hold an Associate’s degree or higher from an accredited college or university or must have successfully passed all of the following collegiate level subject matter courses from an accredited college or university: (a) English composition; (b) Principles of Economics (Macro Economics); (c) Finance; (d) Algebra, Geometry, or higher mathematics; (e) Statistics (f) Computer Science; and (g) Business or Real Estate law.

(4) For applicants taking the examination on or after January 1, 2015: Hold a Bachelor's degree or higher from an accredited college or university.

(5) Complete 2,500 hours of real estate appraisal experience over a minimum of 24 months. Experience must satisfy the Real Estate Appraisal Experience Criteria set forth in 264 CMR 5.06; and

(6) Meet the minimum AQB Real Property Appraiser Qualification Criteria and Interpretations as published by the Appraisal Foundation per criteria specified by federal law, 12 U.S.C. 3345(a).

5.05: Requirements for State-certified General Real Estate Appraisers

Each applicant shall:

(1) Pass the Massachusetts Examination for State-certified General Real Estate Appraisers or an equivalent examination approved by the Board within two years from the date of Board approval to take such examination;

2/1/13 264 CMR - 22 The text of the regulations published in the electronic version of the Massachusetts Register is unofficial and for informational purposes only. The official version is the printed copy which is available from the State Bookstore at http://www.sec.state.ma.us/spr/sprcat/catidx.htm. 264 CMR: BOARD OF REGISTRATION OF REAL ESTATE APPRAISERS

5.05: continued

(2) Complete 300 classroom hours of primary education in real estate appraisal. All courses must be approved by the Board and satisfy the Education Criteria set forth in 264 CMR 5.09 and 9.00: Course Approval Requirements for Providers of Primary and Continuing Education, and the Core Curriculum adopted by the AQB; and

(3) For applicants taking the examination prior to January 1, 2015 (complete applications meeting all other requirements of these regulations must be received by the Board at least 90 days prior to an examination date to ensure meeting this deadline): Hold a Bachelor’s degree or higher from an accredited college or university or must have successfully passed all of the following collegiate level subject matter courses from an accredited college or university: (a) English Composition; (b) Micro Economics; (c) Macro Economics; (d) Finance; (e) Algebra, Geometry, or higher mathematics; (f) Statistics; (g) Computer Science; (h) Business or Real Estate Law; and (i) Two elective courses in accounting, geography, architecture, business management, or real estate; and

(4) For applicants taking the examination on or after January 1, 2015: Hold a Bachelor's degree or higher from an accredited college or university;

(5) Complete 3,000 hours over a minimum period of at least 30 months of real estate appraisal experience. At least 50% of the experience must be non-residential appraisal experience. Experience must satisfy the Real Estate Appraisal Experience Criteria set forth in 264 CMR 5.06; and

(6) Meet the minimum AQB Real Property Appraiser Qualification Criteria and Interpretations as published by the Appraisal Foundation per criteria specified by federal law, 12 U.S.C. 3345(a).

5.06: Experience Criteria

The following specifications apply to the experience requirements for all classifications of licensure and certification.

(1) Experience may include but is not limited, to fee and staff appraisal, ad valorem tax appraisal, review appraisal analysis, real estate counseling, highest and best use analysis, and feasibility analysis/study. (a) Ad valorem tax appraisers shall demonstrate that they use techniques to value properties similar to those used by real estate appraisers and that they effectively use the appraisal process. (b) Components of the mass appraisal process that shall be given credit are highest and best use analysis, model specification (developing the model) and model calibration (developing adjustments to the model). Mass appraisals shall be performed in accordance with Uniform Standards of Professional Appraisal Practice (USPAP) Standards Rule 6. Other components of the mass appraisal process by themselves shall not be eligible for experience credit. (c) Review appraisals, signed by the Reviewer, which are in compliance with USPAP Standards Rule 3 may be awarded experience credit up to a maximum of 50% of the total experience requirement. (d) Appraisal analysis, real estate counseling, and feasibility analysis/study are defined in the USPAP as market analysis, consulting and feasibility analysis, respectively. Experience credit will be awarded for these functions when they are performed in accordance with USPAP Standards Rules 4 and 5. (e) A comparative market analysis (CMA) may be awarded experience credit when the valuation is prepared in conformity with USPAP Standards Rules 1 and 2. (f) All report writing must be performed in compliance with USPAP to qualify for experience credit.

2/1/13 264 CMR - 23 The text of the regulations published in the electronic version of the Massachusetts Register is unofficial and for informational purposes only. The official version is the printed copy which is available from the State Bookstore at http://www.sec.state.ma.us/spr/sprcat/catidx.htm. 264 CMR: BOARD OF REGISTRATION OF REAL ESTATE APPRAISERS

5.06: continued

(g) Experience credit will only be awarded when the applicant has performed or been directly involved in at least 75% of the appraisal process not including the site inspection for any particular appraisal. (h) A minimum of 50% of appraisal experience must be experience in qualifying summary appraisal report writing in compliance with USPAP Standard Rule 2.

(2) An hour of experience is defined as actual verifiable time spent performing tasks in accordance with 264 CMR 5.06 for which reports or file data can be provided.

(3) Experience hours may be treated as cumulative in order to achieve the necessary hours of appraisal experience; however, in accordance with 264 CMR 5.06, a minimum number of calendar months are required.)

(4) All experience to be utilized for purposes of obtaining a license must have been obtained after January 31, 1989 and must be USPAP compliant.

5.07: Experience Audits

(1) The Board or its agents may conduct an audit or request additional documentation to verify an applicant’s claimed experience. Applicants may only claim verifiable experience for which they can provide reports or file data upon a request from the Board.

(2) If an applicant fails to appear before the Board for a scheduled audit or otherwise respond to the Board without good cause within six months of such request, the Board may deny an application for licensure. If an application is denied for failure to appear before the Board for a scheduled audit or provide requested documentation or otherwise respond to the Board within six months of such request, a new application must be filed and an application fee paid by the applicant.

5.08: Primary Education Criteria

The following specifications apply to the Primary Education requirements for all classifications of licensure or certification:

(1) Applicants shall submit official documentation to the Board indicating completion of each course taken to satisfy primary education criteria. It shall be the applicant’s responsibility to ensure that the course provider verifies the number of classroom hours, the length of the education offering, and that the applicant successfully completed an appropriate examination for the course.

(2) Credit will only be granted once for courses taken repeatedly.

(3) The Board may accept credit that was obtained by challenge examination without actual classroom attendance prior to July 1, 1990, provided that the course is approved by the Board. The application shall reflect that credit was obtained by challenge examination.

(4) Credit toward the classroom hour requirement may be awarded to instructors of Board approved courses. Credit will be awarded only once for courses taught repeatedly and shall be limited to the number of hours of the course.

(5) Experience may not be substituted for education.

(6) Credit toward the classroom hour requirement may be awarded for classroom hours previously credited in an application for a different classification of license or certificate.

(7) There is no time frame within which Primary Education credit must be obtained.

(8) Primary Education courses must be approved pursuant to 264 CMR 9.00: Course Approval Requirements for Providers of Primary and Continuing Education prior to the time the applicant completes the course.

2/1/13 264 CMR - 24 The text of the regulations published in the electronic version of the Massachusetts Register is unofficial and for informational purposes only. The official version is the printed copy which is available from the State Bookstore at http://www.sec.state.ma.us/spr/sprcat/catidx.htm. 264 CMR: BOARD OF REGISTRATION OF REAL ESTATE APPRAISERS

5.09: Required Core Curricula

(1) Appraisal Trainee. (a) 30 hours in Basic Appraisal Principles (b) 30 hours in Basic Appraisal Procedures (c) 15 hour National USPAP or National USPAP Equivalency Course Approved by the AQB and the Board

(2) State Licensed Appraiser. (a) 30 hours in Basic Appraisal Principles (b) 30 hours in Basic Appraisal Procedures (c) 15 hour National USPAP or National USPAP Equivalency Course Approved by the AQB and the Board (d) 15 hours in Residential Market Analysis and Highest and best use (e) 15 hours Residential Appraiser Site Valuation and Cost Approach (f) 30 hours Residential Sales Comparison and Income Approaches (g) 15 hours Residential Report Writing and Case Studies

(3) Certified Residential Appraiser. (a) 30 hours in Basic Appraisal Principles (b) 30 hours in Basic Appraisal Procedures (c) 15 hour National USPAP or National USPAP Equivalency Course Approved by the AQB and the Board (d) 15 hours in Residential Market Analysis and Highest and best use (e) 15 hours Residential Appraiser Site Valuation and Cost Approach (f) 30 hours Residential Sales Comparison and Income Approaches (g) 15 hours Residential Report Writing and Case Studies (h) 15 hours Statistics, Modeling and Finance (i) 15 hours Advanced Residential Applications and Case Studies (j) 20 hours Appraisal Subject Matter Electives – may include additional hours in above topics

(4) Certified General Appraiser. (a) 30 hours in Basic Appraisal Principles (b) 30 hours in Basic Appraisal Procedures (c) 15 hour National USPAP or National USPAP Equivalency Course Approved by the AQB and the Board (d) 30 hours in General Appraiser Market Analysis and Highest and Best Use (e) 15 hours Statistics, Modeling and Finance (f) 30 hours in General Appraiser Sales Comparison Approaches (g) 30 hours in General Appraiser Site Valuation and Cost Approach (h) 60 hours in General Appraiser Income Approach (i) 30 hours in General Appraiser Report Writing and Case Studies (j) 30 hours in Other Appraisal Subject Matter Primary Courses – This may include additional hours in above topics

REGULATORY AUTHORITY

264 CMR 5.00: M.G.L. c. 13, § 92; c. 112, §§ 173 through 195.

2/1/13 264 CMR - 24.1 The text of the regulations published in the electronic version of the Massachusetts Register is unofficial and for informational purposes only. The official version is the printed copy which is available from the State Bookstore at http://www.sec.state.ma.us/spr/sprcat/catidx.htm. 264 CMR: BOARD OF REGISTRATION OF REAL ESTATE APPRAISERS

NON-TEXT PAGE

2/1/13 264 CMR - 24.2 The text of the regulations published in the electronic version of the Massachusetts Register is unofficial and for informational purposes only. The official version is the printed copy which is available from the State Bookstore at http://www.sec.state.ma.us/spr/sprcat/catidx.htm. Docket # 75

THE COMMONWEALTH OF MASSACHUSETTS William Francis Galvin Secretary of the Commonwealth

Regulation Filing To be completed by filing agency

CHAPTER NUMBER: 264 CMR 8.00

CHAPTER TITLE: Reciprocity for State-Licensed/State Certified Real Estate Appraisers

AGENCY: Board of Registration of Real Estate Appraisers

SUMMARY OF REGULATION: State the general requirements and purposes of this regulation. This section addresses the Board’s ability to grant reciprocal licenses and licenses by endorsement. With these changes, the Board will meet new federal guidelines designed to reduce barriers on appraisers moving between different states.

REGULATORY AUTHORITY: G.L. c. 112, s. 173 through 195, G.L. c. 13, s. 91

AGENCY CONTACT: Charles Kilb PHONE: 617-727-2707

ADDRESS: Division of Professional Licensure, 1000 Washington St., Boston, MA 02118

Compliance with M.G.L. c. 30A

EMERGENCY ADOPTION - if this regulation is adopted as an emergency, state the nature of the emergency.

PRIOR NOTIFICATION AND/OR APPROVAL - If prior notification to and/or approval of the Governor, Legislature or others was required, list each notification, and/or approval and date, including notice to the Local Government Advisory Commission. Executive Order 485 Approval - 10/9/12 pre hearing, 12/26/12 post hearing Local Government Advisory Commission - 10/11/12 Notice in Mass. Register - 11/9/12; Boston Globe, Springfield Republican - 11/7/12

Date of public hearing or comment period: November 29, 2012

For the first five years: No fiscal impact anticipated

No fiscal effect: No fiscal impact anticipated

Date amended small business impact statement was filed: January 9, 2013

CODE OF MASSACHUSETTS REGULATIONS INDEX - List key subjects that are relevant to this regulation: Real Estate Appraisers, Reciprocity, Endorsement.

ATTESTATION - The regulation described herein and attached hereto is a true copy of the regulation adopted by this agency. ATTEST:

SIGNATURE: SIGNATURE ON FILE DATE: Jan 10 2013

Publication - To be completed by the Regulations Division

MASSACHUSETTS REGISTER NUMBER: 1227 DATE: 02/01/2013

EFFECTIVE DATE: 02/01/2013

CODE OF MASSACHUSETTS REGULATIONS Remove these pages: Insert these pages: 29, 30 29, 30

01/10/2013 cm

264 CMR 8.00: RECIPROCITY FOR STATE-LICENSED/STATE CERTIFIED REAL ESTATE APPRAISERS

Section

8.01: Reciprocity/Licensure by Endorsement

(1) Appraisal trainees are not eligible for reciprocity.

(2) All reciprocity agreements between Massachusetts and any other state are null and void.

(3) An applicant for a license or certificate who holds a current state license, certified residential license or a certified general license or certificate issued by another state may be eligible for a Massachusetts license or certificate provided that: (a) The applicant is coming from a state that is currently in compliance with the requirements of the Appraisal Subcommittee per 12 U.S.C. 3347; and (b) the licensing or credentialing requirements of that state meet or exceed the requirements for licensure in Massachusetts.

(4) The Board may, upon review of the application and accompanying submissions, allow an individual who does not meet the requirements of 264 CMR 8.01(3) to obtain licensure after the successful completion of the Massachusetts examination, additional experience, and/or completion of Massachusetts approved courses.

REGULATORY AUTHORITY

264 CMR 8.00: M.G.L. c. 13, § 92; c. 12, §§ 173 through 195.

2/1/13 264 CMR - 29 The text of the regulations published in the electronic version of the Massachusetts Register is unofficial and for informational purposes only. The official version is the printed copy which is available from the State Bookstore at http://www.sec.state.ma.us/spr/sprcat/catidx.htm. 264 CMR: BOARD OF REGISTRATION OF REAL ESTATE APPRAISERS

NON-TEXT PAGE

2/1/13 264 CMR - 30 The text of the regulations published in the electronic version of the Massachusetts Register is unofficial and for informational purposes only. The official version is the printed copy which is available from the State Bookstore at http://www.sec.state.ma.us/spr/sprcat/catidx.htm. Docket # 5

THE COMMONWEALTH OF MASSACHUSETTS William Francis Galvin Notice of Correction Secretary of the Commonwealth Regulation Filing To be completed by filing agency

CHAPTER NUMBER: 606 CMR 10.00

CHAPTER TITLE: SUBSIDIZED CHILD CARE

AGENCY: Department of Early Education and Care

ORIGINAL PUBLICATION REFERENCE: 1226 Date: 01/18/2013

SUMMARY OF CORRECTION: Technical corrections to the subsidized child care regulations that were published in Register 1226 on 1/18/2013.

AGENCY CONTACT: Carmel C. Sullivan, Esq. PHONE: 617-988-2433

ADDRESS: 51 Sleeper Street, 4th Floor, Boston MA 02210

ATTESTATION - The regulation described herein and attached hereto is a true copy of the regulation adopted by this agency. ATTEST: SIGNATURE: SIGNATURE ON FILE DATE: Jan 18 2013 Publication To be completed by the Regulations Division

MASSACHUSETTS REGISTER NUMBER: 1227 DATE: 02/01/2013 EFFECTIVE DATE: 01/18/2013

CODE OF MASSACHUSETTS REGULATIONS Remove these pages: Insert these pages: 53, 54 53, 54 59, 60 59, 60

01/18/2013 mrs

10.02: continued

Part Time Child Care. Care up to 30 hours per week.

Part Time Service Need. Service need between 20 and up to 30 hours per week.

Protective Services. Families authorized for a child care subsidy based on clinical decision by DCF will be deemed to be in need of protective services, including foster care. Additionally, children may be deemed at risk of needing protective services in special circumstances, wherein families are unable to provide child care for any portion of a 24 hour day due to a situation of domestic violence or homelessness; a physical, mental, emotional or medical condition; or participation in a drug treatment or drug rehabilitation program.

Relative. Sibling, aunt, uncle, or grandparent, whether by birth, marriage or adoption.

Service Need. The amount of time child care is required due to the parent's participation in an approved activity.

State Median Income. The dollar amount which represents the midpoint in a rank ordering of the incomes of all families of the same size in Massachusetts.

Subsidy Administrator. A person or organization authorized or designated by EEC to conduct eligibility determinations for child care subsidies, subject to EEC oversight and review, including but not limited to a CCR&R or contracted child care educator/provider.

Supportive Child Care. A program of comprehensive educational and developmentally appropriate activities augmented by health and nutritional services, case management, social services and transportation, provided by child care educators/providers under contract with EEC to families determined eligible by DCF.

TAFDC. Transitional Aid to Families with Dependent Children.

Vocational Training Program. A program other than graduate, medical or law school, which is intended to teach a specific skill leading to employment.

Voucher Child Care Educator/Provider. A caregiver who provides child care services pursuant to an EEC voucher services agreement.

10.03: General Provisions

The following general provisions apply to all child care subsidies administered by EEC, unless otherwise stated.

(1) Eligibility. (a) Family Composition and Size. Prior to issuing a child care subsidy authorization, subsidy administrators shall verify, through documentary evidence, the family size and household composition of the applicant by verifying the relationship of each child younger than 18 years old, or younger than 24 years old, if the child is a full-time student, who resides in the household and is financially dependent on the parent(s) applying for child care financial assistance. Required documentary evidence shall be readily available to the applicant. Examples of acceptable documentation include: birth certificates; hospital birth records; copies of previously issued EEC child care authorizations or vouchers; social security benefits records; court orders establishing custody or guardianship; or school records verifying the address of the child, as well as the name and relationship of the relative responsible for the child. Any documents which reasonably establish family composition and size must be accepted, and no requirement for a specific type of documentation may be imposed. Parents of teen parents may include the teen parent and his or her child(ren) in the applicant's family size provided that the teen is not receiving EEC financial assistance for his or her child(ren).

2/1/13 (Effective 1/18/13) - corrected 606 CMR - 53 The text of the regulations published in the electronic version of the Massachusetts Register is unofficial and for informational purposes only. The official version is the printed copy which is available from the State Bookstore at http://www.sec.state.ma.us/spr/sprcat/catidx.htm. 606 CMR: DEPARTMENT OF EARLY EDUCATION AND CARE

10.03: continued

(b) Identity. Prior to the initial authorization, the subsidy administrator shall verify, through documentary evidence, the identity of each parent(s) applying for subsidized child care. Required documentary evidence shall contain a photo of the applicant and must be readily available to the applicant. Examples of acceptable documentation include: U.S. passports; certificates of naturalization; driver's licenses, permits or state identification cards; U.S. military cards; non-U.S. passports; or school identification cards. Any documents which reasonably establish identity must be accepted, and no requirement for a specific type of documentation may be imposed. (c) Residency. The subsidy administrator must verify that families seeking child care assistance reside in a Massachusetts household because subsidies administered by EEC are available only to residents of the Commonwealth of Massachusetts. Required documentary evidence shall be readily available to the applicant. Examples of acceptable documentation include: utility bills; property tax bills; individual income tax returns; mortgage documents or home owner insurance documents; vehicle registration cards; residential rental or lease agreements; or letters from shelter programs confirming residence in a Massachusetts shelter program. Any documents which reasonably establish residency must be accepted, and no requirement for a specific type of documentation may be imposed. (d) Citizenship or Immigration Status. In accordance with federal law, the subsidy administrator shall verify, through documentary evidence, the United States citizenship status or immigration status of each child for whom care is requested. Required documentary evidence shall be readily available to the applicant. Examples of acceptable documentation include: U.S. passports; birth certificates; or reports of birth abroad. Any documents which reasonably establish the citizenship or immigration status of the child must be accepted, and no requirement for a specific type of documentation may be imposed. No child shall be denied child care financial assistance based solely on an applicant's failure to demonstrate citizenship or immigration status without final review by EEC. (e) Eligibility Periods. Eligibility is determined for periods not to exceed 12 months, and is renewable subject to the family's continued eligibility for child care financial assistance. Subsidy administrators shall notify families, in writing, that their eligibility period is ending no less than 30 days prior to the end of the eligibility period. (f) Contact Information. In order to remain eligible for a child care subsidy, parents must maintain current address and telephone number information, if any, with the contracted child care educator/provider or CCR&R. A parent who does not have an address or telephone number must maintain as much current contact information as possible with the contracted child care educator/provider or CCR&R. (g) Documentation of Continued Eligibility. In order to remain eligible for a child care subsidy, parents must provide current documentation of income, service need and residence to their subsidy administrator. Such documentation must be provided prior to each voucher or authorization end date. (h) Current Eligibility Information. Parents receiving a child care subsidy must notify their contracted child care educator/provider or CCR&R whenever there is a substantial change that might affect their eligibility to receive financial assistance for early education and care, including significant changes in income (i.e., increases to total household income equaling or exceeding 20% of the previously reported gross income or increases to household income that may render the family ineligible for child care financial assistance, in accordance with 606 CMR 10.04(1)(a)), service need change (i.e., job loss, new employer, change in work or school/training schedule), change in address or change in family size (i.e., new household members) within 14 days of such a change. (i) Child Attendance. In order to remain eligible for a child care subsidy, all children receiving EEC financial assistance shall attend the early education and care program, in accordance with the terms of the child care authorization. Failure to attend the child care program may result in the termination of the child care subsidy for excessive absence, in accordance with 606 CMR 10.13. Children shall not be authorized for early education and care on days that they are regularly scheduled to be absent (i.e., every Friday, homework clubs, etc.). Payment for Child Care Absences. Educators/Providers shall not be paid for more than 30 child absence days in a six month period or for more than three consecutive unexplained absences without written approval from EEC.

1/18/13 606 CMR - 54 The text of the regulations published in the electronic version of the Massachusetts Register is unofficial and for informational purposes only. The official version is the printed copy which is available from the State Bookstore at http://www.sec.state.ma.us/spr/sprcat/catidx.htm. 606 CMR: DEPARTMENT OF EARLY EDUCATION AND CARE

10.05: continued

(b) Transitional Families. The written child care authorization is evidence of family relationship for all children included in the authorization. Subsidy administrators shall verify the identity of the parent(s) listed on the child care authorization issued by DTA, in accordance with 606 CMR 10.03(b). Parents must also submit evidence of their income, service need, residence, and their relationship to children or dependent grandparents not included in the child care authorization.

(4) Eligibility Period. Subsidy administrators should approve the length of time for subsidized child care based on the parent's TAFDC status, as described in 606 CMR 10.05(4)(a) and (b). The subsidy administrator shall notify families, in writing, that their eligibility period is ending no less than 30 days prior to the end of the eligibility period. (a) TAFDC Families. Subsidy administrators shall approve the subsidized child care based on the DTA authorization, not to exceed 12 months, provided that the family continues to receive TAFDC cash assistance. (b) Transitional Families. Subsidy administrators shall approve the subsidized child care based on the parent's service need, not to exceed 12 months from the date the family's TAFDC case closed.

(5) Enrollment. Parents will enroll children directly at the educator/provider child care site, in accordance with the procedures of the educator/provider.

(6) Denial or Termination of Authorization. Parents aggrieved by the denial or termination of a child care authorization by the Department of Transitional Assistance may pursue their grievance through the DTA Fair Hearing Process.

(7) Continuity of Care. Subject to appropriation, parent(s) seeking to continue eligibility upon the closure of the family's DTA Employment Services Program authorization or termination of transitional TAFDC benefits may continue to receive child care financial assistance through the Income Eligible Child Care program provided that the family meets the requirements set forth in 606 CMR 10.03 and 10.04.

10.06: Supportive Child Care Program

Subject to appropriation, DCF may issue authorizations or referrals for children that are receiving, or at risk of receiving protective services, as defined at 606 CMR 10.02, through the Supportive Child Care Program, as described in 606 CMR 10.06(1) through (9). DCF authorizations or referrals for subsidized child care shall be issued in accordance with the regulations, guidelines and policies established by DCF and in accordance with the general provisions for subsidized child care described in 606 CMR 10.03, unless otherwise noted.

(1) Authorization. For any child receiving or at risk of receiving protective services through DCF, DCF may issue a written authorization for child care services to the parent.

(2) Referral and Waitlist. DCF or its designee will determine the appropriateness of and authorize all referrals for supportive child care, and may either: (a) refer the parent to a child care educator/provider with supportive child care openings appropriate to the age and needs of the child; or (b) enter the child on a waitlist for child care, if there are no appropriate openings available.

(3) Eligibility Criteria. DCF or its designee shall determine eligibility of its clients for supportive child care services, in accordance with DCF regulations and policy. The written child care authorization is sufficient documentation that the children listed on the authorization are eligible for supportive child care services. Subsidy administrators shall verify the identity of the parent(s) listed on the child care authorization issued by DCF, in accordance with 606 CMR 10.03(b).

2/1/13 (Effective 1/18/13) - corrected 606 CMR - 59 The text of the regulations published in the electronic version of the Massachusetts Register is unofficial and for informational purposes only. The official version is the printed copy which is available from the State Bookstore at http://www.sec.state.ma.us/spr/sprcat/catidx.htm. 606 CMR: DEPARTMENT OF EARLY EDUCATION AND CARE

10.06: continued

(4) Eligibility Period. The supportive child care subsidy will be authorized by DCF for a maximum of six months, and may be renewed by DCF for a second six month period. Unless approved by the DCF Area Director, authorization for supportive services may not be renewed more than once. Subject to appropriation, DCF may authorize transitional supportive child care to continue beyond the closure of the DCF case for up to six months. The EEC subsidy administrator shall notify families, in writing, that their eligibility period is ending no less than 30 days prior to the end of the eligibility period.

(5) Fee Assessment. On a case by case basis, DCF will determine whether applicable parent fees shall be waived.

(6) Information Sharing. DCF or its designee will share information with the child care educator/provider regarding the child's behavior and the family's psychosocial history to assist the educator/provider in meeting the needs of the child and family.

(7) Enrollment. The parent must meet with the contracted educator/provider to complete the enrollment process in accordance with the educator’s/provider's policies and procedures.

(8) Denial or Termination of Supportive Child Care Services. Supportive Child Care Services will end when the protective case closes, or when DCF determines that services are no longer appropriate, whichever first occurs. Parents wishing to appeal the termination of Supportive Child Care Services may do so through the DCF Fair Hearing Process, in accordance with DCF policy and 110 CMR 10.00: Fair Hearings and Grievances.

(9) Continuity of Care. Subject to appropriation, parent(s) seeking to continue eligibility upon the closure of the family's Supportive Child Care Services may continue to receive child care financial assistance through the Income Eligible Child Care program provided that the family meets the requirements set forth in 606 CMR 10.03 and 10.04.

10.07: Teen Parent Child Care Services Program

Subject to appropriation, teen parents may be eligible to receive subsidized child care through the Teen Parent Child Care Services Program, as described in 606 CMR 10.07(1) through (7), and as provided they meet the requirements of the general provisions for subsidized child care described in 606 CMR 10.03, unless otherwise noted:

(1) Application and Referral. Teen parents may apply for child care subsidies at a CCR&R, a program contracted to provide Teen Parent Child Care services, a local DTA office, or any other location authorized by EEC. At the time of application and at each subsequent redetermination the parents must complete a child care application and fee agreement on forms provided or approved by EEC, and must submit documentation that verifies their income, service need, residence and family relationships, in accordance with EEC regulation and policy. If a teen parent has a current child care authorization from DTA, the authorization is sufficient documentation of their income and service need.

(2) Referral and Waitlist. Based on availability, parents will be referred to and/or enrolled, subject to an eligibility determination, in a program eligible to provide Teen Parent Child Care services. Parents unable to enroll in a Teen Parent Child Care Services Program due to a lack of available funding will be placed on a child care subsidy waitlist.

(3) Eligibility Criteria. Teen parents seeking access to subsidized child care through the Teen Parent Child Care Services Program must comply with the financial and service need requirements of 606 CMR 10.04, unless excepted in 606 CMR 10.07(3)(a) and (b). (a) Service Need Requirements. Unless authorized by DTA or DCF, teen parents must participate in a full time high school program or a high school equivalency (GED) program, or must have received a GED or high school diploma and be participating in an approved higher education, training, and/or work activity, as specified at 606 CMR 10.04(1)(b).

2/1/13 (Effective 1/18/13) - corrected 606 CMR - 60 The text of the regulations published in the electronic version of the Massachusetts Register is unofficial and for informational purposes only. The official version is the printed copy which is available from the State Bookstore at http://www.sec.state.ma.us/spr/sprcat/catidx.htm. Docket # 22

THE COMMONWEALTH OF MASSACHUSETTS William Francis Galvin Secretary of the Commonwealth

Regulation Filing To be completed by filing agency

CHAPTER NUMBER: 956 CMR 7.00

CHAPTER TITLE: Small Group Wellness Incentive Program

AGENCY: Commonwealth Health Insurance Connector Authority

SUMMARY OF REGULATION: State the general requirements and purposes of this regulation. The purpose of this proposed regulation is to implement provisions of M.G.L. c. 176Q, §7A. 956 CMR 7.00 applies to the Small Group Wellness Incentive Program offered to certain employers by the Commonwealth Health Insurance Connector Authority.

REGULATORY AUTHORITY: M.G.L. ch. 176Q, section 7A

AGENCY CONTACT: Edward DeAngelo, General Counsel PHONE: 617-933-3091

ADDRESS: 100 City Hall Plaza, 6th Floor, Boston, MA 02108

Compliance with M.G.L. c. 30A

EMERGENCY ADOPTION - if this regulation is adopted as an emergency, state the nature of the emergency.

PRIOR NOTIFICATION AND/OR APPROVAL - If prior notification to and/or approval of the Governor, Legislature or others was required, list each notification, and/or approval and date, including notice to the Local Government Advisory Commission. Notice of the proposed regulation 956 CMR 7.00 and the public hearing was delivered to the Local Government Advisory Committee on November 20, 2012. Notice of same, including the Small Business Impact Statement, was delivered to the Secretary of State on November 21, 2012.

Date of public hearing or comment period: Hearing: 10:00 a.m. on 1/3/2013 (CCA Boardroom, Boston); Comments Until: 4:00 p.m. 1/4/2013

Date amended small business impact statement was filed: January 7, 2013

CODE OF MASSACHUSETTS REGULATIONS INDEX - List key subjects that are relevant to this regulation:

PROMULGATION - State the action taken by this regulation and its effect on existing provisions of the Code of Massachusetts Regulations (CMR) or repeal, replace or amend. List by CMR number: The proposed regulation 956 CMR 7.00 is new and thus, will not repeal, replace or amend existing provisions of the Code of Massachusetts Regulations.

ATTESTATION - The regulation described herein and attached hereto is a true copy of the regulation adopted by this agency. ATTEST:

SIGNATURE: SIGNATURE ON FILE DATE: Jan 13 2013

Publication - To be completed by the Regulations Division

MASSACHUSETTS REGISTER NUMBER: 1227 DATE: 02/01/2013

EFFECTIVE DATE: 02/01/2013

CODE OF MASSACHUSETTS REGULATIONS Remove these pages: Insert these pages: 1, 2 1, 2 ---- 39 - 42

01/15/2013 mrs

Table of Contents Page

(956 CMR 1.00: RESERVED) 3

956 CMR 2.00: MEDICAID MANAGED CARE ORGANIZATION (MMCO) PARTICIPATION IN COMMONWEALTH CARE HEALTH INSURANCE PROGRAM (COMMONWEALTH CARE) 5

Section 2.01: Authority 5 Section 2.02: Purpose 5 Section 2.03: Scope 5 Section 2.04: Definitions 5 Section 2.05: Administration of the Connector 8 Section 2.06: General Provisions 8 Section 2.07: Administrative Information Bulletins 9 Section 2.08: Severability of Provisions 10

956 CMR 3.00: ELIGIBILITY AND HEARING PROCESS FOR COMMON- WEALTH CARE 11

Section 3.01: Authority 11 Section 3.02: Purpose 11 Section 3.03: Scope 11 Section 3.04: Definitions 11 Section 3.05: Eligibility for Commonwealth Care 14 Section 3.06: Matching Information 15 Section 3.07: Time Standards for an Eligibility Determination 15 Section 3.08: Eligibility Review 15 Section 3.09: Eligibility Requirements 15 Section 3.10: Responsibilities of Applicants and Enrollees 16 Section 3.11: Enrollment, Transfer and Disenrollment 16 Section 3.12: Commonwealth Care Enrollee Premium Contributions 18 Section 3.13: Choosing a Contracted MMCO (Reserved) 20 Section 3.14: Right to a Hearing 20 Section 3.15: Times and Methods for Filing Requests for Hearings 21 Section 3.16: Appeal from Health Plan Actions 21 Section 3.17: Hearings 21 Section 3.18: Administrative Information Bulletins 22 Section 3.19: Severability of Provisions 22

956 CMR 4.00: EMPLOYER SPONSORED HEALTH INSURANCE ACCESS 23

Section 4.01: Authority 23 Section 4.02: Purpose 23 Section 4.03: Scope 23 Section 4.04: Definitions 23 Section 4.05: Employers Subject to M.G.L. c. 151F 24 Section 4.06: Adoption and Maintenance of Section 125 Cafeteria Plan 26 Section 4.07: Filing Section 125 Cafeteria Plan Documents 28 Section 4.08: Other Provisions 28

956 CMR 5.00: MINIMUM CREDITABLE COVERAGE 29

Section 5.01: General Provisions 29 Section 5.02: Definitions 29 Section 5.03: Minimum Creditable Coverage 30 Section 5.04: Administrative Bulletins 32.2 Section 5.05: Severability 32.2

12/25/09 956 CMR - 1 The text of the regulations published in the electronic version of the Massachusetts Register is unofficial and for informational purposes only. The official version is the printed copy which is available from the State Bookstore at http://www.sec.state.ma.us/spr/sprcat/catidx.htm. 956 CMR: COMMONWEALTH HEALTH INSURANCE CONNECTOR AUTHORITY

Table of Contents Page

956 CMR 6.00: DETERMINING AFFORDABILITY FOR THE INDIVIDUAL MANDATE 33

Section 6.01: Authority 33 Section 6.02: Purpose 33 Section 6.03: Scope 33 Section 6.04: Definitions 33 Section 6.05: Determining Affordability 34 Section 6.06: Annual Certification 35 Section 6.07: Hardship Appeals 35 Section 6.08: Grounds for Appeal of Penalty 36 Section 6.09: Hearings 37 Section 6.10: Administrative Information Bulletins 37 Section 6.11: Severability of Provisions 38

956 CMR 7.00: SMALL GROUP WELLNESS INCENTIVE PROGRAM 39

Section 7.01: Purpose 39 Section 7.02: Scope 39 Section 7.03: Definitions 39 Section 7.04: Enrollment Eligibility 40 Section 7.05: Rebate Payment 40 Section 7.06: Appeals 40 Section 7.07: Administrative Information Bulletins 41 Section 7.08: Severability of Provisions 41

2/1/13 956 CMR - 2 The text of the regulations published in the electronic version of the Massachusetts Register is unofficial and for informational purposes only. The official version is the printed copy which is available from the State Bookstore at http://www.sec.state.ma.us/spr/sprcat/catidx.htm. 956 CMR: COMMONWEALTH HEALTH INSURANCE CONNECTOR AUTHORITY

956 CMR 7.00: SMALL GROUP WELLNESS INCENTIVE PROGRAM

Section

7.01: Purpose 7.02: Scope 7.03: Definitions 7.04: Enrollment Eligibility 7.05: Rebate Payment 7.06: Appeals 7.07: Administrative Information Bulletins 7.08: Severability of Provisions

7.01: Purpose

The purpose of 956 CMR 7.00 is to implement the provisions of M.G.L. c. 176Q, § 7A. 956 CMR 7.00 applies to the Small Group Wellness Incentive Program offered to certain employers by the Connector.

7.02: Scope

956 CMR 7.00 contains the Connector's regulations governing the operation of the Small Group Wellness Incentive Program, as specified in M.G.L. c. 176Q, § 7A. The Connector also promulgates other regulations and publishes other documents affecting its programs, including statements of policy and procedure, terms and conditions of participation, guidelines, administrative information bulletins and other documents as necessary.

7.03: Definitions

As used in 956 CMR 7.00, the following terms shall mean:

Connector. Commonwealth Health Insurance Connector Authority established under M.G.L. c. 176Q.

Director. The Executive Director of the Connector.

Eligible Small Employer. Any firm, corporation, partnership or association, including a tax-exempt organization, that purchases a group health plan through the Connector for at least one but not more than 25 Qualified Employees; provided, however, that an employer shall not be an Eligible Small Employer if the employer's sole owner is the only Qualified Employee of that employer.

Initially Enrolled Employees. The number of Qualified Employees enrolled in the group health plan at the time the group health plan is purchased by the Eligible Small Employer through the Connector.

Qualified Employee. Any employee of an Eligible Small Employer, including an owner or a partner in a partnership, who is covered in a group health plan purchased by an Eligible Small Employer through the Connector.

Rebate Payment. A payment to an Eligible Small Employer who completes enrollment and participation requirements for the Small Group Wellness Incentive Program as set by the Connector pursuant to 956 CMR 7.04 and 7.05.

Small Group Wellness Incentive Program. The program authorized by M.G.L. c. 176Q, § 7A to expand the prevalence of employee wellness initiatives by small businesses.

Term. The period beginning on the first of the month following an Eligible Small Employer's enrollment in the Connector's Small Group Wellness Incentive Program and extending for the subsequent 11 months.

2/1/13 956 CMR - 39 The text of the regulations published in the electronic version of the Massachusetts Register is unofficial and for informational purposes only. The official version is the printed copy which is available from the State Bookstore at http://www.sec.state.ma.us/spr/sprcat/catidx.htm. 956 CMR: COMMONWEALTH HEALTH INSURANCE CONNECTOR AUTHORITY

7.04: Enrollment Eligibility

(1) To enroll in the Small Group Wellness Incentive Program and be eligible for a Rebate Payment, an employer must be an Eligible Small Employer.

7.05: Rebate Payment

(1) To qualify for a Rebate Payment, an Eligible Small Employer shall: (a) provide to the Connector, or its designee, prior to the end of a Term, satisfactory documentation that the Eligible Small Employer and at least 33% of the Eligible Small Employer's Initially Enrolled Employees have met participation requirements for the Small Group Wellness Incentive Program as set by the Connector; and (b) provide to the Connector the information needed to calculate the amount of the rebate, on a form and within a time period specified by the Connector.

(2) The Rebate Payment shall, subject to 956 CMR 7.05(5), equal up to 15% of the Eligible Small Employer's share of the amount paid to purchase a group health plan for Qualified Employees through the Connector.

(3) The failure of an Eligible Small Group to meet the requirements of 956 CMR 7.05(1) will result in the Eligible Small Group not receiving a Rebate Payment for that Term.

(4) A Rebate Payment shall be paid to an Eligible Small Employer by the Connector at least annually.

(5) Rebate Payments are contingent on available funding as determined by the Connector. In the event there are insufficient funds, the Director may impose a cap on the number of Eligible Small Employers that may qualify for a Rebate Payment.

(6) Rebate Payment is only available to an Eligible Small Employer for three Terms in which an Eligible Small Employer has qualified for a Rebate Payment in accordance with 956 CMR 7.05(1).

7.06: Appeals

(1) An employer may appeal a decision by the Connector that the employer does not meet the definition of an Eligible Small Employer, that the Eligible Small Employer has not met the participation requirements set forth in 956 CMR 7.05(1), or that the Connector's calculation of the amount of the Eligible Small Employer's Rebate Payment is not correct.

(2) The Connector shall provide written notice to the employer of an adverse decision with respect to eligibility as an Eligible Small Employer, the Eligible Small Employer's satisfaction of participation requirements as set forth in 956 CMR 7.05(1), or the amount of the Eligible Small Employer's Rebate Payment.

(3) The employer must appeal the decision to the Connector within 30 days after the receipt of the notice of the adverse decision. In the absence of evidence to the contrary, the Connector will presume that the notice was received on the third day after mailing. An employer must appeal in writing on a form designated by the Connector.

(4) Appeals brought to the Connector under 956 CMR 7.06 will be heard by a hearing officer designated by the Director. Hearings will be conducted using the policies and procedures set forth for informal hearings pursuant to 801 CMR 1.02: Formal Rules or in any administrative bulletins issued by the Connector pursuant to 956 CMR 7.07. The hearing may be conducted by telephone. The decision may be made based solely on written submissions and documents. The decision of the hearing officer will be the final decision of the Connector.

(5) The Connector's final decision on the appeal will be subject to an action for judicial review under M.G.L. c. 30A, § 14.

2/1/13 956 CMR - 40 The text of the regulations published in the electronic version of the Massachusetts Register is unofficial and for informational purposes only. The official version is the printed copy which is available from the State Bookstore at http://www.sec.state.ma.us/spr/sprcat/catidx.htm. 956 CMR: COMMONWEALTH HEALTH INSURANCE CONNECTOR AUTHORITY

7.07: Administrative Information Bulletins

The Connector may issue administrative information bulletins that set out policies that are consistent with the substantive provisions of 956 CMR 7.00. In addition, the Connector may issue administrative information bulletins that specify the information and documentation necessary to implement 956 CMR 7.00. The Connector may also issue administrative bulletins containing interpretations of 956 CMR 7.00 and other information to assist persons in meeting the obligations under 956 CMR 7.00.

7.08: Severability of Provisions

The provisions of 956 CMR 7.00 are hereby declared to be severable. If any such provisions or the application of such provisions or circumstances shall be held invalid or unconstitutional, such invalidity shall not be construed to affect the validity or constitutionality of any remaining provisions of 956 CMR 7.00 or the application of such provisions or circumstances other than those held invalid.

REGULATORY AUTHORITY

956 CMR 7.00: M.G.L. c. 176Q, § 7A.

2/1/13 956 CMR - 41 The text of the regulations published in the electronic version of the Massachusetts Register is unofficial and for informational purposes only. The official version is the printed copy which is available from the State Bookstore at http://www.sec.state.ma.us/spr/sprcat/catidx.htm. 956 CMR: COMMONWEALTH HEALTH INSURANCE CONNECTOR AUTHORITY

NON-TEXT PAGE

2/1/13 956 CMR - 42 The text of the regulations published in the electronic version of the Massachusetts Register is unofficial and for informational purposes only. The official version is the printed copy which is available from the State Bookstore at http://www.sec.state.ma.us/spr/sprcat/catidx.htm. William Francis Galvin PERIODICALS Secretary of the Commonwealth State Bookstore U.S. POSTAGE PAID State House, Room 116 Boston, MA 02133 Boston, MA

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