December 18, 2012 Meeting Materials

1. Call to order by Carter Beck, M.D., (Committee Chair)

2. Approval of Agenda

3. Approval of November 26, 2012 minutes

4. Legislative Bill priorities - Jean Branscum and Kiely Keane a. Scope of Practice Review Commission b. Peer Review c. Physician Workforce Data Collection, NMCHWA Report, License Data Collection d. Defensive Medicine, Kiely Keane email e. Tort Reform 3/2 year filing limit f. Health Care Provider Transparency

5. Medicaid Reform Workgroup Update – Carter Beck, M.D.

6. Other Legislative items – Carter Beck, M.D. a. Pharmacists and Vaccinations (comments), Medication Care Coordination b. Report on meeting with Governor-elect’s staff c. LAWS list - Health Care, Workers' Compensation

7. Old Business - Updates by Jean Branscum a. In-office Exception for Ancillaries exception to the Stark law b. Frontier definition methodology, Draft Briefing c. Uncompensated Care in Physician Offices

8. National Issues and report on meeting with Senator Baucus’ staff – Jean Branscum

9. Other Business a. Adopted Rule on Enhanced Primary Care Payment

10. Next Meeting: January 15(third Tuesday of Month) at 7:00 PM?

11. Adjourn

Parking Lot Itinerant Surgery Position Paper (Doctor Grmoljez)

Upcoming Meetings January 7: 7:00 AM Legislative Meeting

2013 Tentative Legislative Bill Topics 1. Workers Compensation (reimbursement sunset) 2. Medicaid Provider Reimbursement 3. Tanning Beds and Minors – Need Sponsor 4. Maternal Mortality Tracking 5. Tort Reform 6. Truth in Advertising (Transparency) 7. Itinerant Surgery 8. Medical Education 9. Prescription Drug Registry 10. Patient Centered Medical Homes 11. Scope of Practice Review Committee 12. Peer Review 13. Defensive Medicine 14. Medicaid Reform measures 15. Concussion Youth Athletes Draft – Confidential and Not for Dissemination Committee on Legislation Minutes – Monday, November 26, 2012

Committee on Legislation Monday, November 26, 2012 Telephone Conference Call

Meeting Highlights  Legislative Bills Update: AMA Scope of  Medicaid Reform Workgroup Update Practice Review Committees model bill; Peer  Physician Survey Results Review; Physician Workforce Data; Revised  National Issues – GCPI and Medicare Rule Tanning Draft Bill; Update on “Protection of  Legislative Health Forums Youth Athletes with Head Injuries’”

Motions and Actions  Ms. Branscum and Ms. Keane to work on bill  Ms. Branscum to draft letter of support to draft for BOME regarding Physician AMA opposition to In-office Exception for Workforce Data Ancillaries  Ms. Branscum to contact Legislative  Ms. Branscum to summarize meetings related Leadership and David Hemion regarding ideas to Frontier definition about concepts for Scope of Practice Review  Ms. Branscum will check out Montana Family Committee model bill residency or WWAMI to see if participating in  Ms. Branscum to coordinate meeting with White Coat Day Governor Elect Bullock to ascertain position on potential legislative issues  Ms. Branscum to secure place holder for the six identified MMA legislative priorities

Call to Order Carter E. Beck, M.D., Chair, called the meeting to order at 7:00 p.m. Those in attendance were Michael S. Brown, M.D., Shaun J. Gillis, M.D., Tim J. McInnis, M.D., Joan McMahon, M.D., Paul Grmoljez, M.D., J. Bruce Robertson, M.D., Richard Popwell, M.D., Sheila Idzerda, M.D. Also in attendance were Jean Branscum, Executive Vice President, Kiely Keane, Esq., and Tonya McCormack, Association Management Services Director.

Approve Minutes It was regularly moved and seconded to approve the minutes of October 16, 2012

Legislative Bills Update The Committee discussed the following legislative bills, identifying matters for further follow up.  Protection of Youth Athletes with Head Injuries - Dr. Beck noted he reached out about physician responsibilities and standards. The bill was revised to add new language that would require a physician sign-off showing they understand CDC recommendations related to treatment of concussions.  Peer Review – Ms. Keane provided background on the peer review process and recent Supreme Court decision. She noted it was not a reported decision and thus cannot be used as a precedent. She has reviewed the law and the definition section and will draft bill language to address concerns. Ms. Branscum was directed to request that Senator Bruce Tutvedt put in a place holder for a bill.  Physician Workforce Data Collection - After a general discussion, the Committee decided legislation should be pursued to mandate workforce data collection and the MMLP database be considered for the central location to house this data.

Draft – Confidential and Not for Dissemination Committee on Legislation Minutes – Monday, November 26, 2012  Revised Tanning Draft Bill– Ms. Branscum reported she had spoken with Dr. Kutsch and they were in search of a sponsor for the bill. She noted that Dr. Kutsch was going to reach out to Representative David Hagstrom of Billings to discuss possibility of sponsorship.  AMA Scope of Practice Review Committees model bill – Ms. Branscum was requested to check with Legislative Leadership and David Hemion, Executive Director for the Montana Dental Association, to see if whether or not there was support for a review committee.

Physician Survey Results & MTMedPAC Survey Results Ms. Branscum reviewed the survey results and comments with the Committee. After much discussion the Committee requested Ms. Branscum arrange a meeting with Governor Elect Steve Bullock to discuss and gauge position on tort reform and defensive medicine.

Election Results and Legislative Leadership and Committees Ms. Keane and the Committee discussed the election results and Ms. Keane updated the Committee on the Leadership and Committee Assignments for the 2013 Legislature.

Legislative Priorities The Committee discussed the legislative priorities with the need to limit the focus on no more than five to six bills to present at the December 3, Board of Trustee Meeting. The Committee identified six legislative priorities and requested Ms. Branscum secure place holders for the following: Scope of Practice Review Commission; Health Care Provider Transparency; Physician Workforce Data Collection; Peer Reviews; Defensive Medicine; and the statutory change from 3/2 years for filing a malpractice claim.

National Issues Ms. Branscum indicated she had been contacted by Sami Spencer with the Missoula Bone & Joint and Surgery Center regarding the impact and need for the MMA to take separate action in assisting physicians on fighting the proposed legislation to restrict the provision of in-office exception for ancillary service in medical practices. After a brief discussion by the Committee motion was made and approved to have Ms. Branscum draft a letter in support of AMA opposition to remove In-Office Exception for Ancillaries.

Ms. Branscum discussed with the Committee the Federal Register notice published describing the new Frontier definition methodology. She noted this was addressed at the December 6 and 10 AHEC meetings as well. At the request of the Committee Ms. Branscum agreed to prepare a summary for the Committees consideration in deciding whether to offer comment by January 5.

Other Business Ms. Branscum noted she was following up with the Committee on the Legislative Health Forums arranged by the Alliance for Healthy Montana as they progressed within the 16 communities, noting at the last meeting it was identified it may be beneficial for individual members to participate in local forums to address MMA issues.

Ms. Branscum indicated an inquiry had been as to whether or not the MMA would be participating in White Coat Day at the 2013 Legislature as had been done in the past. After a brief discussion the Committee requested Ms. Branscum check with the Montana Family Residency program or WWAMI to see if the students are doing a White Coat Day during the legislative session.

The Committee confirmed with Ms. Branscum their desire to continue the weekly Legislative Meetings held at 7:00 a.m. on Mondays during session. Individuals or groups wishing to bring forth an issue for consideration would need to contact the MMA Office to be added to the agenda.

Ms. Branscum advised the Committee comment had been submitted on the Administrative Rule proposal for enhanced primary care payment and thanked everyone for their feedback and comments on the rule proposal.

Draft – Confidential and Not for Dissemination Committee on Legislation Minutes – Monday, November 26, 2012 Dr. Grmoljez provided an update on the Itinerant Surgery Position Paper he has been working on, noting the American College of Surgeons, apart from the code of conduct, was unable to come up with any laws that enforce this. After a brief discussion, it was decide once finalized the paper will be placed on the MMA website for reference.

Next Meeting Date Dr. Beck informed the Committee the next meeting date will be Tuesday, December 18, at 7:00 p.m.

Adjourn There being no further business, Doctor Beck adjourned the Legislative Committee meeting at 9:25 p.m.

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Legislative Template: State-based Scope of Practice Review Committees

This template provides an overview of various potential elements of legislation and/or regulation to address the creation of state-level scope of practice review committees.

I. Table of Contents

II. GENERAL OVERVIEW……………………………………………………………………... 1 III. LEGISLATIVE PURPOSE………………………………………………………………….. 2 IV. APPLICATION……………………………………………………………………………... 3 a. In General…………………………………………………………………………...... 3 b. Examples of Legislative Language………………………………………………...... 3 V. DEFINITIONS……………………………………………………………………………….. 3 VI. REQUIREMENTS…………………………………………………………………………… 4 a. Composition of the Scope of Practice Review Committee…………………………… 4 b. Restriction on Public Membership………………………………………………...... 5 c. Compensation…………………………………………………………………………. 6 i. In General…………………………………………………………………...... 6 ii. Examples of Other Legislative Language………………………………...... 6 VII. CREATION OF REVIEW PANEL/SUBCOMMITTEE/WORKING GROUP a. In General…………………………………………………………………………...... 7 b. Points of Interest……………………………………………………………………… 7 VIII. APPLICANTS FOR INCREASE IN SCOPE OF PRACTICE; FACTORS………………. 7 IX. COMMITTEE SCOPE OF PRACTICE REVEIWS AND ANALYSIS…………………… 8 X. FAILURE TO SUBMIT…………………………………………………………..…………. 10 XI. OTHER COMMITTEE DUTIES…………………………………………………...... 10 XII. NOTICE AND PUBLIC HEARING………………………………………………………... 10

II. Overview

State legislatures are routinely overwhelmed with the number of scope of practice proposals they are asked to consider. Oftentimes legislators do not have available to them a thorough, professional and independent understanding of the health and economic implications of such proposals. The creation of a state-level scope of practice review committee, that assesses scope of practice initiatives prior to their introduction at the legislative or regulatory rule-making level, may serve to expose such initiatives to the scrutiny of multiple health care disciplines. These committees have the potential to encourage debate by those most appropriately positioned to consider such issues. They provide a procedure for objective review of proposed changes in the scope of practice of nonphysician practitioners licensed in their state to ensure that the changes contribute to the improvement of the overall health of the state’s citizens.

Several states have passed legislation similar to the proposed model bill, most notably Arizona, Nebraska, and Connecticut. While Arizona has experienced much success with their law, Nebraska’s experience has been more tempered. In addition to the Arizona and Nebraska laws, New Mexico and Texas have seen legislation introduced on this issue in the last 2-3 years. Each one of these bills (AZ, CT, NE, NM, TX) is unique and state specific. For example, each state has addressed the composition of the scope of practice review committee in a different manner (i.e. Arizona’s committee is primarily composed of legislators, while Texas’ Advocacy Resource Center © 2012 American Medical Association. All rights reserved.

committee is a mixture of legislators, state agency leaders, academics and public members, while Connecticut’s committee is composed of individuals representing health care professionals directly affected by the proposed change in scope). As a result, it is strongly recommended that any state medical association considering this type of legislation take into account its unique state needs, political climate, etc., when determining committee composition and other provisions contained in such legislation.

The AMA does not have model state legislation that addresses the creation of scope of practice review committees, nor is there specific AMA policy that addresses this issue. This template provides the Federation with a proactive mechanism that establishes review committees that span the authority of more than one health professional regulatory board in the state. Notably, the template combines the “best of” provisions from legislation introduced on this issue to date and allows for flexibility when defining the composition of the scope of practice review committee.

In this advocacy tool, we have endeavored to highlight various state laws that have attempted to compose scope of practice review committees. We hope that the information in this template will be a useful tool for states that wish to advocate for such legislation.

III. Legislative purpose

The following is a compilation of the “best of” provisions from all legislation introduced on this issue. This is meant only as an example and can be altered on an as needed basis:

The Legislature hereby finds and declares that:

a. The Legislature is routinely overwhelmed with the number of proposals it is asked to consider that recommend changes in healthcare practitioner scopes of practice.

b. Oftentimes legislators may not have available to them a thorough, professional and independent understanding of the health and economic implications of such recommendations on an individual basis.

c. Currently, when a healthcare practitioner scope of practice change is proposed, the [NAME OF STATE] Legislature must consider many complex issues in a relatively short time frame.

d. Effective legislative decision-making is dependent on each legislator having access to balanced, thoroughly researched information.

e. The purpose of this Act is to:

i. Provide a procedure for objective review of proposed changes in the scope of practice of healthcare practitioners licensed in this state to ensure that the changes contribute to the improvement of the overall health of people in this state; and

ii. Establish a committee to make recommendations to the [INSERT NAME OF STATE] Legislature.

IV. Application

a. General

The legislation should cover any health professional group or organization or individual that proposes to increase the scope of practice of a health profession.

b. Examples of legislative language

“‘Applicant group’ means any health professional group or organization, any individual or any other interested party that proposes that any health professional group not presently regulated be regulated or that proposes to increase the scope of practice of a health profession.” ARIZ. REV. STAT. ANN. § 32-3101 (1).

“Any person or entity, acting on behalf of a health care profession that seeks to establish a new scope of practice or change the profession’s scope of practice…” CONN. GEN. STAT. ANN. § 19a-16d(a).

“‘Applicant group’ shall mean any health professional group or organization, any individual or any other interested party that proposes that any health professional group not presently regulated be regulated or that proposes to increase the scope of practice of a regulated health profession.” NEB. REV. STAT. § 71-6204.

“…A member of a licensing board, a licensee or the licensing board or any other person seeking a change in the scope of practice of a health profession…” NM SB 381 (First Session, 2005) (Sec. 4(A)).

“…A person who seeks to change the scope of practice of a health profession, including a person who is a member of the relevant licensing entity or a license holder in that profession…” TX HB 2706 (2005) (Sec. 113.101(a)).

“Any professional or occupational group or organization, any individual or any other interested party which proposes the regulation of any unregulated professional or occupational group or organization, or who proposes to establish, revise or expand the scope of practice of a regulated profession or occupation...” WV SB 214 (March 6, 2012)

V. Definitions

Every state will have to determine what definitions it needs to provide in order to ensure this legislation is clear and unambiguous. Each statute or piece of legislation discussed in this template differs in this regard.

The following is a sampling of definitions that ARC staff recommends that any state medical association consider prior to introduction of this type of legislation:

a. “Applicant group” means any health professional group or organization, any individual or any other interested party that proposes to increase the scope of practice of its profession.

b. “Committee” means the Scope of Practice Review Committee.

c. “Health profession” means a health-related activity or occupation for which a person must hold a license under this title.

d. “License” includes a license, certificate, registration, permit, or other authorization issued by a licensing entity.

e. “Licensing entity” means an agency, board, department, commission, or other entity that issues a license under this title to practice a specific health profession.

f. “Scope of practice” means those activities that a person licensed to practice a health profession is permitted to perform, as prescribed by the appropriate statutes and by rules adopted by the appropriate licensing entity.

VI. Requirements

a. Composition of the scope of practice review committee

i. Considerations

1. When establishing a scope of practice review committee, a state should ensure that it is administratively attached to a specific state agency.

2. The members of the Committee ought to be defined in statute.1

3. If a state decides to include, as a member of the Committee, an employee of a state agency representative of an institution of higher education, that member ought to be designated by that agency or institution.

4. States should consider allowing their respective governor to appoint any public members of the Committee.

5. States should consider naming the commissioner of the appropriate state department or agency as the chair of the Committee.

ii. State approaches

1. Arizona: “…consisting of five members of the senate appointed by the president of the senate, one of whom shall be a member of the senate appropriations committee, and five members of the house of representatives appointed by the speaker of the house of representatives, one of whom shall be a member of the house of representatives appropriations committee. Selection of members shall be based on their understanding and interest in legislative audit oversight functions. Not more than three appointees of each house shall be of the same political party. The president and the speaker shall designate one of their

1 The issue of committee composition is a critical one. Several states (AZ, CT, NE, NM, TX) have approached the committee composition issue, which the resulting legislative language differing significantly from one state to the next. Any state medical association considering this type of legislation needs to consider its unique state needs, political climate, etc., when determining committee composition. Advocacy Resource Center © 2012 American Medical Association. All rights reserved. 4

appointed members as chairman of their respective delegation. The chairman of the audit committee shall serve for the term of each legislature. The chairmanship of the audit committee shall alternate… The president of the senate and the speaker of the house of representatives shall also serve as ex officio members of the committee…”2

2. Connecticut: “[T]he Commissioner of public Health shall, within available appropriations allocated to the department, establish and appoint members to a scope of practice review committee for each timely scope of practice request submitted to the department…. Committees established pursuant to this section shall consist of the following members: (1)Two members recommended by the requestor to represent the health care profession making the scope of practice request; (2) two members recommended by each person or entity that has submitted a written impact statement… to represent the health care profession directly impacted by the scope of practice request; and (3) the Commissioner of Public Health or the commissioner’s designee, who shall serve as an ex-officio, nonvoting member of the committee. The Commissioner of Public Health or the commissioner's designee shall serve as the chairperson of any such committee. The Commissioner of Public Health may appoint additional members to any committee established pursuant to this section to include representatives from health care professions having a proximate relationship to the underlying request if the commissioner or the commissioner's designee determines that such expansion would be beneficial to a resolution of the issues presented.”3

3. Nebraska: “The director [of Regulation and Licensure] with the advice of the [state] board [of health] shall appoint an appropriate technical committee to examine and investigate each application. The committee shall consist of six appointed members and one member of the board designated by the board who shall serve as chairperson of the committee. The chairperson of the committee shall not be a member of the applicant group… or any health profession which is directly or indirectly affected by the application. The director shall ensure that the total composition of the committee is fair, impartial, and equitable. In no event shall more than two members of the same regulated health profession, the applicant group… serve on the technical committee.”4

4. New Mexico: “The commission responsible under this construct is the New Mexico Health Policy Commission, which is an independent State agency whose mission is to improve access and quality health care for all New Mexicans by providing timely, relevant health care information and analysis on health policy research and planning issues. This commission has the authority to appoint an “…ad hoc review panel of sufficient numbers and expertise to review and make recommendations on the proposed change. Each panel: (1) shall include one board member of the licensing board for the health profession from which the

2 ARIZ. REV. STAT. ANN. § 32-3101 et seq. 3 CONN. GEN. STAT. ANN. § 19a-16e(a) 4 NEB. REV. STAT. § 71-6201 et seq. Notably, Nebraska’s law provides that the technical committee file a report with the state board of health and the director of regulation and licensure. The state board of health then files a separate report with the director of regulation and licensure. Finally, the director of regulation and licensure prepares a final report for various members of the Legislature. Advocacy Resource Center © 2012 American Medical Association. All rights reserved. 5

proposed change in scope of practice originates; (2) may include one additional member from the profession from which the proposed change originates who shall be from the professional association of that profession; and (3) shall have at least one-fourth of its membership as individuals who have no economic interest in the profession originating the request for a change in scope of practice…”5

5. Texas: “(a) The commission consists of the following members: (1) the commissioner of the Department of State Health Services; (2) an employee of the Legislative Budget Board who works in the Texas Performance Review section; (3) a representative of the Center for Public Policy Dispute Resolution at The University of Texas School of Law; (4) a representative of the Health Law and Policy Institute at the University of Houston; (5) an employee of the Texas Legislative Council who has expertise in scope of practice issues; and (6) two representatives of the public. (b) A member who is an employee of a state agency or representative of an institution of higher education shall be designated by that agency or institution. (c) The governor shall appoint the public members of the commission.”6

6. West Virgina: “The committee is composed of fifteen members as follows, five members of the Senate, to be appointed by the President, with no more than three being from the same political party, five members of the House of Delegates, to be appointed by the Speaker, with no more than three being from the same political party; and Five citizen members from this state who are not legislators, public officials or public employees, to be appointed by the Speaker of the House and the President of the Senate, with no more than three being from the same political party and at least one of whom shall reside in each congressional district of this state. The committee has two cochairs, one selected by the President of the Senate from the members appointed from the Senate and one selected by the Speaker of the House of Delegates from the members appointed from the House of Delegates.”7

b. Restriction on public membership

Texas’ legislation, in Sec. 113.053, places restrictions on public membership. This is an important component to this legislation. It ensures a balanced composition of this Committee. The following are some examples of possible language – all taken from Texas’ HB 2706:

i. In this section, “[NAME OF STATE] trade association” means a cooperative and voluntarily joined statewide association of business or professional competitors in this state designed to assist its members and its industry or profession in dealing with mutual business or professional problems and in promoting their common interest.

ii. A person may not be a public member of the Committee if:

1. The person is an officer, employee, manager, or paid consultant of a [NAME OF STATE] trade association in the field of health care;

2. The person’s spouse is an officer, manager, or paid consultant of a [NAME OF STATE] trade association in the field of health care;

3. The person is required to register as a lobbyist under [CITATION OF APPROPRIATE STATE STATUTE] because the person’s activities for compensation on behalf of a health profession related to the activities of the Committee; or

4. The person has a direct financial interest in a health care profession or is employed within the health care industry.

iii. Examples of other legislative language

Some states, rather than address the issue of public membership in a separate section of the legislation, simply define “public member” in the definitions section. Examples of this tactic are as follows:

1. “‘Public member’ means an individual who is not and never has been a member or spouse of a member of the health profession being regulated and who does not have and never has had a material financial interest in either the rendering of the health professional service being regulated or an activity directly related to the profession being regulated.” ARIZ. REV. STAT. ANN. § 32-3101(10).

2. “Public member, defined. Public member shall mean an individual who is not, and never was, a member of the health profession being regulated, the spouse of a member, or an individual who does not have and never has had a material financial interest in the rendering of the health professional service being regulated or an activity directly related to the profession being regulated.” NEB. REV. STAT. § 71-6216. c. Compensation

i. General

“When considering this legislation, states ought to consider requiring that any member of the Committee not receive compensation for service as a Committee member.” TX HB 2706 (2005) (Sec. 113.055).

“All members of the committee are entitled to compensation and reimbursement for expenses as authorized for members of the Legislature in accordance with the performance of their interim duties.” W. Va. Code, § 4-10-4

ii. Examples of other legislative language

“Committee members shall receive no salary, but shall be reimbursed for their actual and necessary expenses as provided in sections…” NEB. REV. STAT. § 71-6227(3).

“Any member of such committee shall serve without compensation.” CONN GEN. STAT. ANN. § 19a-16e(a)

VII. Creation of the review panel / subcommittee working group

a. General

States considering the development of this type of legislation, should consider allowing the Committee to create a review panel, subcommittee or working group to assist in performing the Committee’s duties.

b. Points of interest

i. It ought to be mandated that any such panel/subcommittee/working group ought to consist of persons other than members of the Committee.

ii. Also, the name, occupation, employer, and community of residence of each member of the review panel/ subcommittee/working group must be made part of the record of the Committee and detailed in any report resulting from the work of the review panel/subcommittee/working group. TX HB 2706 (2005) (Sec. 113.056).

VIII. Applicants for increase in scope of practice; factors

Each statute or piece of legislation discussed in this template differs in this regard. The following is a sampling of factors that ARC staff recommends that any state medical association consider prior to introduction of this type of legislation.

This language is a compilation of the “best of” provisions found in existing law and/or legislation.

a. Applicants, applicant groups, members of a licensing board, a licensee of the licensing board or any other person seeking a change in the scope of practice of a healthcare practitioner profession shall notify the respective licensing board and request a hearing on the proposal.

b. This request shall be submitted on or before August 1 prior to the start of the legislative session for which the legislation is proposed.

c. The licensing board, upon receiving such request, shall notify the Committee and shall:

i. Collect data, including information from the applicant and all other appropriate persons, necessary to review the proposal;

ii. Conduct a technical assessment of the proposal, if necessary, with the assistance of a technical review panel established for that specific purpose, to determine whether the proposal is within the profession’s current scope of practice; and

iii. Provide its analysis, conclusions and any recommendations, together with all materials gathered for the review, to the Committee.

d. The person or entity seeking the change in scope of practice shall provide the licensing board with all information requested, including: Advocacy Resource Center © 2012 American Medical Association. All rights reserved. 8

i. A summary of state and/or federal laws that govern the health care profession making the request;

ii. A summary of the state’s current regulatory oversight of the health care profession making the request;

iii. A definition of the problem and why a change in scope of practice is necessary including the extent to which consumers need and will benefit from practitioners with this scope of practice;

iv. The extent to which the public can be confident that qualified practitioners are competent including:

1. Evidence that the profession’s regulatory board has functioned adequately in protecting the public;

2. Whether effective quality assurance standards exist in the health profession, such as legal requirements associated with specific programs that define or endorse standards or a code of ethics; and

3. Evidence that state approved educational programs provide or are willing to provide core curriculum adequate to prepare practitioners at the proposed level.

v. The extent to which the proposed scope of practice increase may harm the public including the extent to which the proposed increase will restrict entry into practice and whether the proposed increase requires registered, certified or licensed practitioners in other jurisdictions who migrate to this state to qualify in the same manner as state applicants for registration, certification and licensure as those in this state;

vi. The cost to [NAME OF STATE] and to the general public of implementing the proposed scope of practice increase; and

vii. A detailed statement of the proposed funding mechanism to pay the administrative costs of the regulation or the establishment, revision or expansion of the scope of practice, or of the fee structure conforming with the statutory requirements of financial autonomy.

viii. A detailed statement of the location and manner in which the group plans to maintain records which are accessible to the public.

ix. Any proposal which contains a continuing education requirement for a health profession shall be accompanied by evidence that such a requirement has been proven effective for the health profession.

IX. Committee scope of practice reviews and analysis

Each statute or piece of legislation discussed in this template differs in this regard. The following is a sampling of requirements related to a Committee’s review and analysis that ARC staff recommends that any state medical association consider prior to introduction of this type of legisaltion.

This language is a compilation of the “best of” provisions found in existing law and/or legislation.

a. Upon receipt of notice, as required under Section 4 (c) (b) of this Act, the Committee shall review and make recommendations on the proposed scope of practice change.

b. In performing its duties under this Section, the Committee shall:

i. Familiarize itself with the Committee’s rules on procedures and criteria for such reviews;

ii. Ensure appropriate public notice of its proceedings;

iii. Invite testimony from persons with special knowledge in the field of the proposed change;

iv. Assess the proposal using the following criteria:

1. Whether the proposed change could potentially harm the public health, safety, or welfare;

2. Whether the proposed change will benefit the health, safety and welfare of health consumers;

3. What economic impact on overall health care delivery the proposed change is likely to have;

4. Whether potential benefits of the proposed change outweighs potential harm;

5. Whether the public can be adequately protected by other means in a more cost- effective manner; and

6. The extent to which the proposed changes will affect the availability, accessibility, delivery and quality of health care in [INSERT NAME OF STATE].

v. Evaluate the quality and quantity of the training provided by health care professional degree curricula and post-graduate training programs to healthcare practitioners in active practice with regard to the increased scope of practice proposed;

vi. Whether the practice of the profession or occupation requires specialized skill or training which is readily measurable or quantifiable so that examination or training requirements would reasonably assure initial and continuing professional or occupational competence

vii. Determine whether a need exists for the proposed scope of practice change;

viii. Draft a report that includes findings from subparagraph (iv) above, as well as:

1. A review of other states that have a scope of practice for the relevant profession that is identical or similar to the proposed change and any available information on how that scope of practice has affected the quality and cost of health care in the state;

2. A review of any statutory or regulatory changes that were required in the other state to implement the identical or similar scope of practice change;

3. An objective and balanced review that examines the extent to which the potential benefits predicted by proponents of the change or concerns raised by opponents of the change materialized after the scope of practice change took effect in the other state;

4. This report must include evidence-based legislative recommendations for each proposed scope of practice change submitted to the Committee; and

ix. The Committee shall report, not later than December 31 of each year, the results of its review to the:

1. Governor;

2. Lieutenant Governor;

3. Speaker of the House of Representatives;

4. President of the Senate; and

5. standing committees of the [NAME OF STATE] Senate and House of Representatives having jurisdiction over [APPROPRIATE ISSUES, I.E. STATE FINANCE, HEALTH AND HUMAN SERVICES, ETC.].

X. Failure to submit

Any state considering this type of legislation ought to address the issue of an applicant groups failure to submit their legislative proposal for a scope of practice expansion by the deadline set forth in this legislation.

An example of this type of language is as follows: “[a]ny bill that proposes to expand, contract or change the scope of practice of a healthcare practitioner profession that was not submitted to the Committee will not be considered by [NAME OF STATE] Legislature.”

XI. Other committee duties

States ought to consider mandating that as the Committee determines appropriate, the Committee ought to conduct other reviews and perform research on issues related to the scope of practice of a health profession, including retrospective reviews of scope of practice changes.

In addition, this Committee ought to be allowed to provide assistance to the respective states’ Legislature, on an as needed basis, with regard to a proposed health profession scope of practice change.

This Committee should also provide staff services to any review panel/subcommittee/ working group established under this law.

Finally, states ought to consider allowing these Committees to have the power of legislative subpoena. ARIZ. REV. STAT. ANN. § 41-1279(C)(3).

XII. Notice and public hearing

States considering this type of legislation ought to legislate the following to ensure an open and fair process:

a. that the Committee shall notify, on an annual basis, each licensing entity and, whenever possible, each professional association and group of health professions, of both the Committee’s duties under this Act; and

b. that a public hearing conducted under this Act shall be open to the public and is subject to the requirements of the appropriate state statute.

Updated 10/2/12

Add Legislative Intent language in support of peer review

50-16-201. Definitions. As used in this part, the following definitions apply: (1) (a) "Data" means written reports, notes, or records or oral reports or proceedings created by or at the request of a utilization review, peer review, medical ethics review, quality assurance, or quality improvement committee of a health care facility that are used exclusively in connection with quality assessment or improvement activities, including the professional training, supervision, or discipline of a medical practitioner by a health care facility. Data includes all subsequent evaluations of the event, including any and all analysis, opinions and/or conclusions of the reviewer(s). (b) The term does not include: (i) incident reports or occurrence reports; or (ii) health care information that is used in whole or in part to make decisions about an individual who is the subject of the health care information. (2) "Health care facility" has the meaning provided in 50-5-101. (3) (a) "Incident reports" or "occurrence reports" means a written business record of a health care facility, which may be created in response to an untoward event, such as a patient injury, adverse outcome, or interventional error, for the purpose of ensuring a prompt evaluation of the event. (b) An incident or occurrence report is limited to the factual rendition of the event. It is created by the staff involved and does not include any analysis, opinions, or conclusions regarding the event or other events and/or circumstances. (cb) The terms An incident or occurrence report doesdo not include any subsequent evaluations of the event whether or not in the subsequent evaluation of the event occurred in response to an incident report or occurrence report created by or at the request of a utilization review, peer review, medical ethics review, quality assurance, or quality improvement committee. The creation of an incident or occurrence report is not a condition precedent for the subsequent evaluation of an event. (4) "Medical practitioner" means an individual licensed by the state of Montana to engage in the practice of medicine, osteopathy, podiatry, optometry, or a nursing specialty described in 37-8-202 or licensed as a physician assistant pursuant to 37-20-203. History: En. Sec. 4, Ch. 104, L. 1969; R.C.M. 1947, 69-6304; amd. Sec. 1, Ch. 359, L. 2001; amd. Sec. 5, Ch. 396, L. 2003; amd. Sec. 124, Ch. 467, L. 2005; amd. Sec. 25, Ch. 519, L. 2005.

Draft dated 12/12/12 ‐‐‐‐‐Original Message‐‐‐‐‐ From: Murdo, Patricia [mailto:[email protected]] Sent: Monday, August 20, 2012 6:32 PM To: 'Foster, Michael' Cc: Jean Branscum Subject: thoughts on bill draft for medical licensing issues

Hi ‐ Based on our conversation regarding the medical licensing issues, here are some thoughts:

For the data‐gathering add to 37‐1‐131(1)(a) Duties of boards ‐‐ quorum required ‐‐‐ add a new subsection: (iii) collect data as part of the licensing procedure that may be used to determine specifics, including but not limited to geographic location and type of practice, regarding a licensed person's profession or occupation provided that the data, if used without personal identifying information, is needed for a statewide planning purpose to improve public health, safety, or welfare.

Add a new statute: It is the intent of the legislature that a board serve a public purpose and, secondarily, the purpose of serving consumers and the interests of the licensed profession or occupation. As part of that public purpose, a board shall include within the licensing procedure: (1) requirements to gather data determined necessary by the board or by a state agency, as defined in 2‐15‐141, that supplies the board with a rational basis for needing information on a long‐term basis provided that the information, after being gathered and when shared, does not personally identify the licensee; and (2) an expedited review for licensing that incorporates reciprocity under 37‐1‐304 and that presumes qualifications for a temporary license unless protection of the public health, welfare, or safety supersedes granting a temporary license.

So, after toying with this language I see that there are constitutional concerns about privacy vs. the public need to know. There also is a question whether the 37‐1‐131 change needs to be made for all licensing boards. I think there may be a reason for it but this would be a requirement "the board shall..." and that may be a broader requirement than is needed since it would cover all boards.

But the concepts might work, under your hands, and they are just suggestions, after all. I also can see that the new statute (2) provision might do no good if a board were to say that the public health, welfare, or safety supersedes granting the license. There already is a provision in Title 10, chapter 3, for Hurricane Katrina events when general public health, welfare, or safety is at stake. 10‐3‐‐118 allows interstate licensure of a "volunteer professional" so perhaps there needs to be a different approach there. ‐ pat

The New Mexico Center for Health Workforce Analysis At the University of New Mexico, Health Sciences Center

Report to the New Mexico State Legislature October 31, 2012

Submitted on Behalf of: Dr. Paul Roth, Chancellor University of New Mexico, Health Sciences Center

And

Dr. Art Kaufman, Vice-Chancellor for Community Health and Director, Office for Community Health, University of New Mexico, Health Sciences Center

And

Dr. Richard Larson, Executive Vice-Chancellor; Vice Chancellor for Research University of New Mexico, Health Sciences Center

Report Prepared by:

Dr. Sam Howarth, Director, New Mexico Center for Health Workforce Analysis and Senior Fellow, Robert Wood Johnson Center for Health Policy at UNM

Table of Contents

Background page 1 Introduction page 1 Project Team page 3 NMCHWA Healthcare Workforce Work Group page 5 Transfer of Data page 6 The Data page 6 Going Forward page 8 Center Financing page 10

Appendix A House Bill 19, the Health Care Workforce Data Collection, Analysis and Policy Act page 11

Background House Bill 19 (Representative Mimi Stewart, 2012 legislative session) authorizes the University of New Mexico, Health Sciences Center to create the New Mexico Center for Health Workforce Analysis (NMCHWA). Signed into law by the Governor in February 2012, the Health Care Workforce Data Collection, Analysis and Policy Act (Act) authorizes the transfer of health professional licensure and survey data from the New Mexico Department of Health and the New Mexico Regulation and Licensing Department to the UNM Health Sciences Center for analysis. The Act also requires health professional licensing boards to conduct electronic surveys of their health professionals. Lastly, the Center is to submit reports annually to the Legislature by October 1st, inclusive of recommendations from a comprehensive NMCHWA Healthcare Workforce Work Group that will be convened under the direction of the HSC Chancellor, Dr. Paul Roth.

Introduction Funds were not appropriated with this Act. However, the Chancellor of the UNM Health Sciences Center has a strong commitment to implementing the requirements of the Act and has temporarily redirected resources in order to support the Act’s requirements in this first year. With these temporary resources, significant progress has been made. In the eight months since the Act was signed into law, the Chancellor or Health Sciences Center staff have: • Created the New Mexico Center for Health Workforce Analysis, housed at the UNM Health Sciences Center’s Office for Community Health • Identified and temporarily reassigned staff to begin work at the NMCHWA • Negotiated with the Robert Wood Johnson Center for Health Policy at UNM for additional staff support • Committed diverse UNM Health Sciences Center leadership to support NMCHWA data analyses and to participate on the NMCHWA Working Group • Completed a Memorandum of Understanding, thereby entering into an agreement with the State of New Mexico that will allow for the ongoing transfer of health professional and licensure data to the NMCHWA • Overseen the transfer of a now complete set of health professional data from the NM Department of Health, the NM Regulation Department, the Board of Nursing and the Medical Board to the NMCHWA • Allocated secure server capacity at the UNM Health Sciences Center’s Clinical Translational Science Center to store health professional workforce and licensure data • Supported preliminary data testing, methodology testing (assuring that the methodologies used by the NMCHWA are the same as the methodologies used prior by the NM Department of Health and the New Mexico Health Policy Commission to assure longitudinal congruency) and preliminary analyses

The Chancellor of the UNM Health Sciences Center recognizes the importance of the work contained within the Act. It is anticipated that in the coming year, the work of the NMCHWA will include the completion of health professional workforce analyses that will inform policy makers, institutions of higher education and other stakeholders on concrete ways to increase the number of health professionals serving in the state, improve access to healthcare, and, ultimately, improve the health of New Mexicans. It should be noted that to sustain, enrich and expand this work and the analyses and reports issued by the NMCHWA, additional external funding will be needed. Towards this end, the University of New Mexico will be making a legislative request during the 2013 legislative session and will continue to seek grant funding.

This report further details progress to date.

Project Team Currently, the New Mexico Center for Health Workforce Analysis Project Team includes the following individuals:

• Dr. Arthur Kaufman Vice-Chancellor for Community Health, UNM Health Sciences Center Director, Office of Community Health, UNM Health Sciences Center Distinguished Professor, Family and Community Medicine, UNM Health Sciences Center Primary Investigator, NM Center for Health Workforce Analysis, UNM Health Sciences Center

Dr. Kaufman has a long history of educational innovation at the UNM School of Medicine. His innovations have focused on the role of problem-based learning and community-oriented learning in medical education. His focus has been education for rural practice and for service to the underserved. He was one of the key drivers of the School of Medicine’s Primary Care Curriculum, the School’s Health of the Public Program and he oversaw the expansion of the Family Medicine residency into three rural sites. He has published extensively on research in innovations in medical education.

• Dr. Sam Howarth Assistant Research Professor, Department of Economics at UNM Senior Fellow, Robert Wood Johnson Foundation Center for Health Policy at UNM Director, NM Center for Health Workforce Analysis, UNM Health Sciences Center

Dr. Howarth is uniquely qualified to direct this project. Prior to joining the Department of Economics and the Robert Wood Johnson Center for Health Policy at UNM, he was the Executive Director of the New Mexico Health Policy Commission where he oversaw the collection, storage and analyses of the Hospital Inpatient, County Indigent Fund, and Geographic Access System (GADS) data. The GADS data (health professional licensure data), in addition to newer health professional survey data, are the data that will be housed and analyzed by the NMCHWA.

• Dr. Maurice Moffett Research Assistant Professor, Department of Family & Community Medicine, UNM Health Sciences Center Health Economist, UNM Health Sciences Center Senior Fellow, Robert Wood Johnson Foundation Center for Health Policy, UNM Project Economist and Data Analyst, NM Center for Health Workforce Analysis, UNM Health Sciences Center

Dr. Moffett has over ten years of experience conducting econometric analyses in health services research. He has evaluated the future demand for primary care physicians in New Mexico and evaluated the supply of nurse practitioners in the state. Dr. Moffett has served as a labor economist for the NM Department of Labor (now called Workforce Solutions) evaluating market dynamics using the unemployment insurance database and mass layoff impact using input-output models. Prior to joining the Department of Family & Community Medicine and the Robert Wood Johnson Center for Health Policy at UNM, he was a researcher at the Baylor College of Medicine, Michael E. DeBakey VA Medical Center and the West Virginia University Heath Sciences Center. Dr. Moffett has the skills and experience to lead the modeling, forecasting and analysis of health workforce data through the NMCHWA.

The project is further supported by Dr. Richard Larson, Executive Vice Chancellor for Research at the UNM Health Sciences Center who, through the Clinical Translational Science Center, has agreed to house the health professional licensure and survey data. He has also agreed to temporarily redirect some staff time to maintain the databases that contain these data and provide some limited staff support to assist Dr. Moffet with data queries and analyses.

As dedicated funding is identified for the center, permanent staff can be supported.

Additionally, a cross-disciplinary group of Health Sciences Center and other university leaders will participate on the statutorily-required, and soon-to-be- convened, NMCHWA Healthcare Workforce Work Group. The Chancellor has already identified the following, internal, representatives to participate on the Work Group. These individuals represent leadership at the UNM Health Sciences Center responsible for health professional training: • Dr. Richard Larson, Executive Vice Chancellor; Vice Chancellor for Research • Dr. Valerie Romero-Leggott, Vice Chancellor for Diversity • Dr. Tom Williams, Executive Dean of the School of Medicine • Dr. David Sklar, Associate Dean and Designated Institutional Official for Graduate Medical Education • Dr. Lynda Welage, Dean of the College of Pharmacy • Dr. Nancy Ridenour, Dean of the College of Nursing, and • Dr. Leslie Danielson, Associate Dean of Health Professions and Public Health, which includes, the public health program, occupational therapy, physical therapy, dental programs, emergency medical services, physician assistants program, radiologic sciences, nuclear medicine imaging, and medical laboratory sciences

NMCHWA Healthcare Workforce Work Group The Act stipulates that the Chancellor is to convene the Healthcare Workforce Work Group (Work Group). The Work Group is to advise and support the Center on all activities. It is to have representation from: • Health care consumers • Health care providers • Organized groups representing physicians, physician assistants, nurses, nurse practitioners, dentists, dental hygienists and pharmacists • Health care work force training institutions • The NM Department of Health • The NM Public Education Department • The Higher Education Department, and • Health professional licensing boards

In addition to advising the Center, the Work Group is to: • Analyze and make recommendations to the legislature regarding incentives to attract qualified individuals, including those from minority groups underrepresented among health care professions, to pursue health care education and practice in New Mexico • Develop a short-term plan and a five-year plan to improve health care access, with a draft report on the plans to be submitted to the interim legislative health and human services committee by November 1, 2011. Beginning October 1, 2012, the work group shall make detailed annual reports to the legislative health and human services committee by October 1 of each year • Analyze the collected data and make recommendations to the legislature for building healthier communities and improving health outcomes, and • Devise an electronic survey, designed to be completed by applicants within fifteen minutes, for boards to provide to applicants for licensure or renewal of licensure, which includes questions regarding the information required pursuant to Subsection C of Section 24-14C-5 NMSA 1978 and any other survey questions that the chancellor and the work group deem appropriate

In the coming weeks, NMCHW will be meeting with State and university officials to identify the appropriate membership to make up the Work Group. It is anticipated that membership will include members from: • The UNM Health Sciences Center as indicated above and other New Mexico institutions of higher education • The New Mexico Workforce Assessment and Recommendation Partnership, convened by the NM Department of Workforce Solutions of the course of 2011 to develop strategies to increase new Mexico’s health professional shortages • Various and representative health professional licensing boards and commissions, and • Various professional organizations and consumer groups

It is the intent of the Chancellor to convene the first meeting of the NMCHW before the end of 2012.

Transfer of Data As indicated, the Act authorizes the transfer of health professional licensure and survey data from the New Mexico Department of Health, the New Mexico Regulation and Licensing Department, the Board of Nursing and the NM Medical Board to the New Mexico Center for Health Workforce Analysis at the UNM Health Sciences Center for analysis.

To date, the NMCHWA has received: • 2006 – 2010 health professional licensure data from the NM Department of Health • 02/2010 – 09/2012 physician survey data from the NM Medical Board, and • 2010 nurse survey data from the NM Board of Nursing

While the transfer of all 2006 – 2010 data went quickly, it took some time to finalize the required Memorandum of Understanding (MOU) between the UNM Health Sciences Center and the NM Regulation and Licensing Department that would allow for the transfer of the 2011 and subsequent year data. The MOU was finalized on September 19, 2012.

The Data As such, the NMCHWA now has a complete set of health professional licensure data (2006 – 2010) for the following health professionals: • Medical Doctors: primary care and specialty • Physician Assistants • Nurses: RNs, NPs, LPNs • Midwives: Licensed and Certified • Dentists: general and specialty • Other dental practitioners: Hygienists and Dental Assistants • Pharmacists, Pharmacy Clinicians, Pharmacy Techs • Behavioral health professionals: Psychiatrists, Psychologists, Social Workers, Counselors • Certified First Responders • Emergency Medical Technicians: Basics, Intermediates, Paramedics • Chiropractors, and • Doctors of Osteopathic Medicine

As required by the Act, all licensed health professionals must complete a survey designed by their respective licensing boards. To date, the NM Board of Medicine and the NM Board of Nursing have required their members to complete such surveys. Both boards require their members to complete surveys when their

members apply for initial licensure or make re-application for licensure (every three years for MDs and every two years for nurses). The Medical Board is in its fourth year requiring physicians to complete a survey with licensure application/re- application and the Board of Nursing is in its third year. As such, the NMCHWA has survey responses for a complete cohort of both MDs and nurses. (Other health professional boards are in the process of developing and/or administering their surveys and the NMCHWA will be reaching out to these Boards to assist them in the development of surveys as needed.)

Whereas, the health professional licensure data for the various health professionals provides only limited information (license type, area of specialization if any, licensee address by county, and licensee gender and age), the survey data are much richer, providing an opportunity for much more complex and interesting analyses.

The MD survey, for example, provides data on the following indicators: • Current work status o Practice in: NM, TX, AZ, CO or other o Inactive o Retired o Resident or fellowship training • Current activities o Weeks per year practice in NM o Hours per week practice in NM o Time allocation: direct patient care/research/teaching/administration • Training and Education: New Mexico/other U.S. state or Canada/foreign trained • Practice specialties by effort allocation for primary and secondary specialties • Admitting privileges • Reimbursement • Practice location • Practice setting o Practice size o Ownership o Current capacity o Electronic medical record capabilities o Referral difficulties o Recruitment difficulties • Demographics o Gender o Race/ethnicity • Near future practice plans

The nursing survey provides data on the following indicators: • Demographics o Gender o Age o Race/ethnicity (starting in 2011) • License status • Employment status (starting in 2010) • Practice specific o Practice area (Starting 2010) o Location of employment (Starting in 2010): hospital/clinic/home health/etc. o Geographic location (Starting in 2011) • Education location

All licensure and survey data have been successfully transferred and is stored on secure servers at the Clinical Translational Science Center at the UNM Health Sciences Center for access by the NMCHWA team. Additional and regular transfers of new data will be made as those data are collected by the NM Regulation and Licensing Department, the NM Board of Nursing and NM Medical Board.

Going Forward As indicated above, the Chancellor will convene the Healthcare Workforce Work Group before the end of 2012. At this time the Center is positioned to begin running queries of the licensure and survey data and undertake analyses of these data. In addition to the early runs performed to assure methodological consistency of the GADS data, the Center has begun some preliminary runs and analyses. In collaboration with the NM Center for Nursing Excellence, the Center for Education Policy and Research at UNM, and the Center for Behavioral Health Research and Training at UNM, the Center has begun to look at the location, license type, and practices of nurses in New Mexico.

Over the course of the coming year the Center will: • Complete two new GADS reports using 2010 and 2011 health professional licensure data. These reports will show where the various health professionals, by licensure type and specialty, are located in the state. The report will also examine the age and gender of the various health professionals. These reports are important as they allow for longitudinal comparisons with the same data and reports from prior years published by the New Mexico Health Policy Commission. • Analyze physician and nurse survey data and issue reports. As indicated above, responses to these surveys provide much more and much richer information about the work of these health professionals in the state. For example, we anticipate producing reports on actual FTEs of nurses and physicians providing direct patient care, and their respective FTEs

performing administrative functions or teaching. Additionally, we anticipate issuing reports on: o The race/ethnicity of physicians and nurses, o An analysis of their educational backgrounds and if where they were educated seems to impact their decisions to work in New Mexico o An analysis of the payer sources for care o An analysis of the populations being served o Factors related to part- or full-time work status o Diffusion of electronic medical record utilization o Determinants of near future plans to retire or change practice locations, and o Other analyses and reports as determined in collaboration with the Healthcare Workforce Work Group • These reports, including recommendations, will be made available to the legislature and other stakeholders to inform policymakers about the status of the health professional workforce in New Mexico and ways to increase the numbers of health professionals serving in New Mexico. • Meet with the NM Regulation and Licensing Department and the various health professional licensing boards to determine progress by the boards implementing Section 5 of the Health Care Workforce Data Collection, Analysis and Policy Act that requires that all health professional licensing boards implement an electronic survey of their members that collects, at a minimum, the following data: o Demographics, including race, ethnicity and primary and other languages spoken o Practice status, including, but not limited to: . active practices in New Mexico and other locations . Practice type, and . Practice settings, such as hospitals, public schools, higher education institutions, clinics and other clinical settings . Education, training and primary and secondary specialties for all health professions as appropriate . Average hours worked per week and the average number of weeks worked per year in the licensed profession over the past twelve months . Percentage of practice engaged in direct patient care and in other activities, such as teaching, research and administration, in the licensed profession . Practice plans for the next five years, including retiring from a health care profession, moving out of state or changing health care work hours, and . Professional liability insurance costs and availability as they relate to barriers to practice

Once this assessment of progress has been completed, the Center will assist all health-related licensing boards that have not completed an on-line survey to develop and conduct electronic surveys of their licensees. As this occurs, the Center will receive and analyze these data and produce similar analyses as those listed above for these additional health professions.

Center Financing To date, project activities have been provided on a temporary basis by redirecting staff from the UNM Health Sciences Center and the Robert Wood Johnson Center for Health Policy. Center staff is in the process of pursuing funding to support NMCHWA activities. In September 2012, the Center was notified that it had received grant funding from the Association of American Medical Colleges. The grant will provide $80,000/year for three years. This grant requires the Center to do specific analyses that focus on health professional workforce shortages in urban areas. The Health Sciences Center is requesting an appropriation of $265,000 during the 2013 legislative session. Additionally the Center will continue to seek grant and/or other funding.

Appendix A

HB19 (Representative Mimi Stewart, 2012 Session of the New Mexico State Legislature)

The Health Care Work Force Data Collection, Analysis and Policy Act

11 AN ACT

RELATING TO HEALTH CARE; AMENDING SECTIONS OF THE HEALTH CARE

WORK FORCE DATA COLLECTION, ANALYSIS AND POLICY ACT TO DIRECT

THAT THE UNIVERSITY OF NEW MEXICO ASSUME DATA-RELATED DUTIES

PURSUANT TO THAT ACT; PROVIDING THE DEPARTMENT OF HEALTH

ACCESS TO DATA; TRANSFERRING ALL DATA, APPROPRIATIONS,

PROPERTY, PERSONNEL, RECORDS AND CONTRACTS RELATED TO DATA

COLLECTION, ANALYSIS, STORAGE OR USE UNDER THE HEALTH CARE

WORK FORCE DATA COLLECTION, ANALYSIS AND POLICY ACT FROM THE

DEPARTMENT OF HEALTH TO THE UNIVERSITY OF NEW MEXICO.

BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF NEW MEXICO:

SECTION 1. Section 24-14C-1 NMSA 1978 (being Laws 2011,

Chapter 152, Section 1) is amended to read:

"24-14C-1. SHORT TITLE.--Chapter 24, Article 14C NMSA

1978 may be cited as the "Health Care Work Force Data

Collection, Analysis and Policy Act"."

SECTION 2. Section 24-14C-2 NMSA 1978 (being Laws 2011,

Chapter 152, Section 2) is amended to read:

"24-14C-2. DEFINITIONS.--As used in the Health Care

Work Force Data Collection, Analysis and Policy Act:

A. "board" means any state health care work force licensing or regulatory board, including the New Mexico medical board; the board of osteopathic medical examiners; the

New Mexico board of dental health care; the board of nursing; HHGAC/HB 19 Page 1 the board of pharmacy; any other licensing or regulatory board that the chancellor designates; any other health professional licensing board listed in Chapter 61 NMSA 1978; and the university;

B. "chancellor" means the chancellor for health sciences of the university of New Mexico;

C. "database" means the health care work force database created pursuant to the Health Care Work Force Data

Collection, Analysis and Policy Act;

D. "ethnicity" means an individual's self- identification or affiliation as either "Hispanic or Latino" or "not Hispanic or Latino" according to cultural, historical, linguistic or religious ties;

E. "New Mexico center for health care workforce analysis" means a state entity that collects, analyzes and reports data regarding the state's health care work force and collaborates with the federal national center for health care workforce analysis pursuant to Section 5103 of the federal

Patient Protection and Affordable Care Act;

F. "race" means an individual's self- identification or affiliation with one of the following categories used to identify individuals according to historical or phenotypical characteristics:

(1) American Indian or Alaska Native;

(2) Asian; HHGAC/HB 19 Page 2 (3) Black or African American;

(4) Native Hawaiian or other Pacific

Islander;

(5) White; or

(6) a mixture of any of the categories listed in Paragraphs (1) through (5) of this subsection; and

G. "university" means the university of New

Mexico."

SECTION 3. Section 24-14C-3 NMSA 1978 (being Laws 2011,

Chapter 152, Section 3) is amended to read:

"24-14C-3. HEALTH CARE WORK FORCE DATABASE--COLLECTION

OF DATA--HOUSING OF DATA--ANALYSIS AND REPORTING.--

A. Subject to the availability of state, federal or private foundation funding or other sources of funding, the chancellor shall create and maintain the "health care work force database". The chancellor shall:

(1) enter into agreements with entities to create, house and provide information to state agencies, the legislature and the governor and, as the legislature or governor deems appropriate, any others regarding the state's health care work force; and

(2) seek federal or other sources of funding to create a New Mexico center for health care workforce analysis and to ensure the additional funding and staffing needed to achieve the anticipated outcomes. HHGAC/HB 19 Page 3 B. A board shall supply the university with data pertaining to licensed health care providers for inclusion in the database. A board shall collect a core essential data set at the time of new licensure or licensure renewal, including, but not limited to, a provider's:

(1) demographics, including race, ethnicity and primary and other languages spoken;

(2) practice status, including, but not limited to:

(a) active practices in New Mexico and other locations;

(b) practice type; and

(c) practice settings, such as hospitals, public schools, higher education institutions, clinics and other clinical settings;

(3) education, training and primary and secondary specialties for all health professions as appropriate;

(4) average hours worked per week and the average number of weeks worked per year in the licensed profession over the past twelve months;

(5) percentage of practice engaged in direct patient care and in other activities, such as teaching, research and administration, in the licensed profession;

(6) practice plans for the next five years, HHGAC/HB 19 Page 4 including retiring from a health care profession, moving out of state or changing health care work hours; and

(7) professional liability insurance costs and availability as they relate to barriers to practice.

C. The chancellor shall provide to the department of health, in a manner that conforms to department of health rules, access to health care work force data that the university administers pursuant to the Health Care Work Force

Data Collection, Analysis and Policy Act."

SECTION 4. Section 24-14C-4 NMSA 1978 (being Laws 2011,

Chapter 152, Section 4) is amended to read:

"24-14C-4. DATABASE ESTABLISHMENT AND MAINTENANCE--

DELEGATION.--

A. The chancellor may contract and collaborate with a private or public entity to establish and maintain the database, to analyze data collected, to develop reports for the legislature or the executive branch or to perform other duties to carry out the provisions of the Health Care Work

Force Data Collection, Analysis and Policy Act.

B. An entity that establishes, maintains or analyzes data or develops reports by contract pursuant to

Subsection A of this section shall provide to the department of health, in a manner that conforms to department of health rules, access to any health care work force data that the entity establishes, maintains, analyzes or reports." HHGAC/HB 19 Page 5 SECTION 5. Section 24-14C-5 NMSA 1978 (being Laws 2011,

Chapter 152, Section 5) is amended to read:

"24-14C-5. HEALTH CARE WORK FORCE DATA COLLECTION BY

BOARDS--MANDATORY COMPLIANCE FOR APPLICANTS--REPORTING BY

BOARDS--CONFIDENTIALITY OF DATA--RULEMAKING.--

A. An applicant for a license from a board or renewal of a license by a board shall provide the information prescribed by the chancellor pursuant to Subsection C of this section. This section applies to applicants for health professional licensure or renewal of health professional licensure pursuant to Chapter 61 NMSA 1978.

B. A board shall not approve a subsequent application for a license or renewal of a license until the applicant provides the information pursuant to Subsection C of this section.

C. A board shall adopt rules regarding the manner, form and content of reporting data; the consistency of data entry fields used; and the information that an applicant, pursuant to Subsection A of this section, shall provide to a board. At a minimum, the rules shall provide for a core essential data set, including the applicant's:

(1) demographics, including race, ethnicity and primary and other languages spoken;

(2) practice status, including, but not limited to: HHGAC/HB 19 Page 6 (a) active practices in New Mexico and other locations;

(b) practice type; and

(3) education, training and primary and secondary specialties;

(4) average hours worked per week and the average number of weeks worked per year in the licensed profession;

(5) percentage of practice engaged in direct patient care and in other activities, such as teaching, research and administration, in the licensed profession; and

(6) practice plans for the next five years, including retiring from the health care profession, moving out of state or changing health care work hours.

D. A board shall report health care work force information collected pursuant to this section to the chancellor.

E. A board shall keep confidential and not release personally identifiable data collected under this section for any person licensed, registered or certified by the board.

The provisions of this subsection do not apply to the release of information to a law enforcement agency for investigative purposes or to the release to the chancellor for state health HHGAC/HB 19 Page 7 planning purposes. A person with whom the university contracts to perform data collection, storage and analysis shall protect the privacy of that data. The chancellor shall ensure that the responses of applicants shall be kept confidential, including taking special precautions when the identity of an applicant may be ascertained due to the applicant's location or occupation.

F. A board shall promulgate rules as necessary to perform the board's duties pursuant to this section, including rules for collecting, storing and analyzing data in addition to the information required to be collected by the Health Care

Work Force Data Collection, Analysis and Policy Act."

SECTION 6. Section 24-14C-6 NMSA 1978 (being Laws 2011,

Chapter 152, Section 6) is amended to read:

"24-14C-6. HEALTH CARE WORK FORCE WORK GROUP--WORK

FORCE DATA ANALYSIS--RECRUITMENT PLANNING--STRATEGIC PLAN FOR

IMPROVING HEALTH CARE ACCESS--WORK FORCE SURVEY.--The chancellor for health sciences of the university of New Mexico shall convene a health care work force work group that includes representatives of health care consumers; health care providers; organized groups representing physicians, physician assistants, nurses, nurse practitioners, dentists, dental hygienists and pharmacists; health care work force training institutions; the department of health; the public education department; the higher education department; and the boards. HHGAC/HB 19 Page 8 The work group shall:

A. analyze and make recommendations to the legislature regarding incentives to attract qualified individuals, including those from minority groups underrepresented among health care professions, to pursue health care education and practice in New Mexico;

B. develop a short-term plan and a five-year plan to improve health care access, with a draft report on the plans to be submitted to the interim legislative health and human services committee by November 1, 2011. Beginning

October 1, 2012, the work group shall make detailed annual reports to the legislative health and human services committee by October 1 of each year;

C. analyze the collected data and make recommendations to the legislature for building healthier communities and improving health outcomes; and

D. devise an electronic survey, designed to be completed by applicants within fifteen minutes, for boards to provide to applicants for licensure or renewal of licensure, which includes questions regarding the information required pursuant to Subsection C of Section 24-14C-5 NMSA 1978 and any other survey questions that the chancellor and the work group deem appropriate."

SECTION 7. Laws 2011, Chapter 152, Section 7 is amended to read: HHGAC/HB 19 Page 9 "SECTION 7. TEMPORARY PROVISION--APPLICATION FOR GRANTS

PURSUANT TO THE FEDERAL PATIENT PROTECTION AND AFFORDABLE CARE

ACT.--In order to carry out the provisions set forth in the

Health Care Work Force Data Collection, Analysis and Policy

Act, the chancellor for health sciences of the university of

New Mexico shall seek funding pursuant to Section 5102 of the federal Patient Protection and Affordable Care Act, as well as funding from any other source, public or private, that the chancellor deems appropriate."

SECTION 8. TEMPORARY PROVISION--TRANSFER OF DATA,

APPROPRIATIONS, PROPERTY, PERSONNEL, RECORDS AND CONTRACTS TO

THE BOARD OF REGENTS OF THE UNIVERSITY OF NEW MEXICO.--On July

1, 2012:

A. all data, appropriations, property, personnel and records related to data collection, analysis, storage or use pursuant to the Health Care Work Force Data Collection,

Analysis and Policy Act shall be transferred from the department of health to the university of New Mexico; and

B. any contracts related to data collection, analysis, storage or use that are binding on the department of health pursuant to the Health Care Work Force Data Collection,

Analysis and Policy Act shall be binding on the board of regents of the university of New Mexico. HHGAC/HB 19 Page 10

Advancing Briefing: Solutions Licensed Health Professions’ Workforce Data Collection

Developed out of an initiative As passed by the 2009 Oregon State Legislature, Enrolled HB 2009-C includes language from the Governor's office that directs the Office of Oregon Health Policy and Research (OHPR) to collaborate with and sustained by dedicated seven health profession licensing boards representing key shortage occupations to collect health care, education and health care workforce data via the licensing and renewal processes. The workforce data to business professionals from be collected includes information on demographics, education, employment setting, private industry and the public practice location(s), anticipated changes in the practice, and languages spoken. sector, the Oregon Healthcare Workforce Institute (OHWI) is Provision of the data is required as a condition of relicensing and applies to occupational a non-profit public/private therapists, occupational therapy assistants, physicians, physician assistants, nurses, partnership that exists to nursing assistants, dentists, dental hygienists, physical therapists, physical therapist coordinate and advance a assistants, pharmacist, pharmacy technician, and dietitians. A licensing board may not comprehensive statewide response to Oregon’s growing approve a subsequent license renewal application until the health professional provides the health care workforce needs. workforce information. The law: Authorizes the licensing boards and the Oregon Health Policy Board to set fees to be paid by licensees to cover the cost of obtaining and reporting health care

OHWI's efforts include workforce information. research and analysis of health workforce supply and Authorizes the licensing boards to keep confidential a licensee’s personally demand data, expansion of identifiable workforce data collected under this effort. This does not apply to the educational program and release of information to law enforcement for investigative purposes or clinical training capacity, information released to OHPR for state health planning purposes. development and evaluation of public policies affecting Allows boards to take steps prior to the January 1, 2010 effective date in order to

Oregon’s health workforce begin the data collection effort. and convening interested parties for collaborative DEVELOPMENT OF A LICENSEE DATA COLLECTION WORK PLAN In 2008 the Oregon Healthcare Workforce Institute convened the Executive Directors problem solving, funding and information sharing. from the health profession licensing boards, health workforce and research experts and others to develop a work plan to collect accurate, consistent, uniform health care

workforce data routinely via the licensing process. The work group identified a phased-in data collection effort, targeting key access and shortage occupations. The frequency and method of data collection, whether in a paper application or online format, are determined by the individual board’s licensing renewal process. The plan identified essential workforce data collection questions that build off the current questions included on each board’s applications and will be designed and formatted to fit each occupation.

Oregon Healthcare An ongoing, accurate data collection system that reveals crucial workforce elements, such

Workforce Institute as the number of active practitioners, clinical specialties, geographic distribution and 4000 Kruse Way Place Building 2, Suite 210 diversity, is intrinsic to address the health care workforce shortage effectively. Health Lake Oswego, Oregon 97035 workforce data will help target finite public resources, inform educational capacity 503-479-6002 expansion and employment training programs, evaluate health care workforce-related www.oregonhwi.org policies and even help Oregon prepare for and respond to emergency and disaster

situations.

Continued on reverse Enrolled HB 2009-C: Healthcare Workforce Data

SECTION 1174. The Office for Oregon Health Policy and Research shall create and maintain a healthcare workforce database that will provide information upon request to state agencies and to the Legislative Assembly about Oregon's healthcare workforce, including: (a) Demographics, including race and ethnicity. (b) Practice status. (c) Education and training background. (d) Population growth. (e) Economic indicators. (f) Incentives to attract qualified individuals, especially those from underrepresented minority groups, to healthcare education.

(2) The Administrator for the Office for Oregon Health Policy and Research may contract with a private or public entity to establish and maintain the database and to analyze the data. The office is not subject to the requirements of ORS chapters 279A, 279B and 279C with respect to the contract.

SECTION 1175. 1) As used in this section, 'healthcare workforce regulatory board' means the: (a) Occupational Therapy Licensing Board; (b) Oregon Medical Board; (c) Oregon State Board of Nursing; (d) Oregon Board of Dentistry; (e) Physical Therapist Licensing Board; (f) State Board of Pharmacy; and (g) Board of Examiners of Licensed Dietitians.

(2)(a) An applicant for a license from a healthcare workforce regulatory board or renewal of a license by a healthcare workforce regulatory board shall provide the information prescribed by the Office for Oregon Health Policy and Research pursuant to subsection (3) of this section. (b) Except as provided in subsection (4) of this section, a healthcare workforce regulatory board may not approve a subsequent application for a license or renewal of a license until the applicant provides the information.

(3) The Administrator for the Office for Oregon Health Policy and Research shall collaborate with the healthcare workforce regulatory boards to adopt rules for the manner, form and content for reporting, and the information that must be provided to a healthcare workforce regulatory board under subsection (2) of this section, which may include: (a) Demographics, including race and ethnicity. (b) Education information. (c) License information. (d) Employment information. (e) Primary and secondary practice information. (f) Anticipated changes in the practice. (g) Languages spoken.

(4)(a) A healthcare workforce regulatory board shall report healthcare workforce information collected under subsection (2) of this section to the Office for Oregon Health Policy and Research. (b) A healthcare workforce regulatory board shall keep confidential and not release personally identifiable data collected under this section for a person licensed, registered or certified by a board. This paragraph does not apply to the release of information to a law enforcement agency for investigative purposes or to the release to the Office for Oregon Health Policy and Research for state health planning purposes.

(5) The requirements of subsection (2) of this section apply to an applicant for issuance or renewal of a license who is or who is applying to become: (a) An occupational therapist or certified occupational therapy assistant as defined in ORS 675.210; (b) A physician as defined in ORS 677.010; (c) A physician assistant as defined in ORS 677.495; (d) A nurse or nursing assistant licensed or certified under ORS 678.010 to 678.410; (e) A dentist or dental hygienist as defined in ORS 679.010; (f) A physical therapist or physical therapist assistant as defined in ORS 688.010; (g) A pharmacist or pharmacy technician as defined in ORS 689.005; or (h) A licensed dietitian, as defined in ORS 691.405.

(6) A healthcare workforce regulatory board may adopt rules as necessary to perform the board's duties under this section.

(7) In addition to licensing fees that may be imposed by a healthcare workforce regulatory board, the Oregon Health Policy Board shall establish fees to be paid by applicants for issuance or renewal of licenses reasonably calculated to reimburse the actual cost of obtaining or reporting information as required by subsection (2) of this section.

SECTION 1176. Sections 1174 and 1175 of this 2009 Act become operative on January 1, 2010.

SECTION 1177. A healthcare workforce regulatory board, as defined in section 1175 of this 2009 Act, and the Office for Oregon Health Policy and Research may take any action prior to the operative date specified in section 1176 of this 2009 Act that is necessary to enable a board or the office to exercise, on and after the operative date specified in section 1176 of this 2009 Act, all the duties, functions and powers conferred on a board and the office by sections 1174 and 1175 of this 2009 Act.

SECTION 1178. Section 1175 of this 2009 Act applies to an application for a license or license renewal filed on or after the operative date specified in section 1176 of this 2009 Act.

THE MONTANA MEDICAL CARE EFFICIENCY AND COST CONTAINMENT THROUGH THE REDUCTION OF DEFENSIVE MEDICINE WHEN TREATMENT RECOMMENDATIONS ARE BASED ON PHYSICIAN JUDGMENT ACT.

WHEREAS, it is in the interest of all Montanans that medical costs be controlled; and

WHEREAS, a majority of responding physicians admit to practicing defensive medicine on a regular basis; and

WHEREAS, defensive medicine is the practice of ordering medical tests, procedures, treatments, therapeutic interventions, or consultations of limited clinical value, often at the request of the patient in an effort to avoid litigation; and

WHEREAS, in order to control costs, the law should encourage physicians to avoid practicing defensive medicine and provide patients with care needed based on the physician's medical judgment made at the point of care if that clinical judgment meets the standard of care; and

WHEREAS, nationally the costs of defensive medicine as a subset of medical costs are substantial and are estimated to be from $45 to $126 billion annually; and

WHEREAS, the costs of defensive medicine will begin to be contained when physicians are allowed to make decisions based on sound medical judgment even though that treatment may ultimately prove not to be as successful as hoped; and

WHEREAS, the medical record is used by physicians to document information related to patient encounters, including his/her assessment and plan for patient care; and

WHEREAS, under Montana law, if there are two or more appropriate methods of diagnosing or treating a particular condition or ailment, a physician may properly select and follow one of the approved methods. See, for example, Juedeman v. Montana Deaconess Medical Center, 223 Mont. 311, 321-22, 726 P.2d 301, 307 (1986); and

WHEREAS, in an effort to control costs by addressing defensive medicine and in accordance with Montana law as to physician judgment, it is in the interest of all Montanans to preclude a finding of negligence against a physician when the physician, using his/her considered medical judgment selects, with the patient, a medically acceptable course of treatment and documents his/her rationale at the time of treatment for prescribing or not prescribing, recommending, and/or ordering a given test, procedure, treatment, consultation, or other therapeutic intervention and that rationale meets the standard of care; and

WHEREAS, under Montana law, when a physician in his/her medical judgment selects a medically appropriate course of treatment with the patient, a physician may not be found negligent: (1) because of his/her medical judgment with regard to the selected course, or (2) because the course of treatment followed was ultimately not successful, or (3) because the patient did not experience the desired outcome or result. See, for example, Hunsaker v. Bozeman Deaconess Foundation, 179 Mont. 305, 329, 588 P.2d 493, 506 (1978).

BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF MONTANA:

Section 1. Short title. [Sections 2 and 3] may be cited as the "Montana Medical Care Efficiency and Cost Containment Through the Reduction of Defensive Medicine when Treatment Recommendations are Based on Physician Judgment Act".

Section 2. Definitions. As used below, the following definitions apply:

(1) "Documented rationale" means a brief, comprehensive statement made by the physician in the patient's medical record at the time of treatment, which includes the physician's clinical rationale for prescribing or not prescribing, recommending and/or ordering a given test, procedure, treatment, consultation, or other therapeutic intervention.

(2) “Physician” is defined at 37-3-102.

Section 3. Preclusion of a finding of negligence against a physician when the physician uses acceptable medical judgment in determining an appropriate course of treatment, which is documented in the patient file. (1) For the purposes of a medical malpractice claim asserted against a physician in any court of law in this state in which an act or omission by the physician is alleged to have resulted in injury to a patient, the physician may not be found negligent if, using his/her medical judgment, the physician selects, with the patient, a medically acceptable course of treatment and documents in the medical record his/her rationale at the time of treatment for prescribing or not prescribing, recommending, and/or ordering a given test, procedure, treatment, consultation, or other therapeutic intervention. (2) A physician may, further, not be found negligent because: (a) the course of treatment followed was ultimately not successful, and/or (b) the patient did not experience the desired outcome or result.

Section 4. This section does not impose any additional duty on a physician.

Section 5. Saving clause. [This act] does not affect rights and duties that matured, penalties that were incurred, or proceedings that were begun before [the effective date of this act].

- END -

 Include PAs and Nurse Practitioners?

2 Becky Zaharko

To: Jean Branscum Subject: RE: Legislation samples-draft defensive medicine

From: Kiely Keane [mailto:[email protected]] Sent: Tuesday, December 18, 2012 3:34 PM To: Jean Branscum; Carter E. Beck, M.D.; Carter E. Beck, M.D./Kathleen Ryan; Shaun J. Gillis, M.D.; [email protected] Subject: RE: Legislation samples-draft defensive medicine

Thanks Jean! The safe harbor information is very interesting, with a layered approach. I think it would be something to keep in mind as we explore addressing defensive medicine. Since it has some moving parts, I think it could be a project for the next session if the MMA decides to go that direction. However, I am happy to discuss that further if the MMA would like to pursue it.

During our discussion last week, we talked about a different approach with the defensive medicine bill as cost containment. We also discussed the need to provide some peace of mind to physicians with this bill. With those goals in mind and as an initial point of discussion, I put together an initial draft of a revised defensive medicine bill. As we discussed, I do not think we will be able to obtain upfront immunity for physicians. However, the goal of this initial draft was to provide a framework where if physicians document their rationale and then end up in litigation, 3 good jury instructions could be pulled from this statute for the physician’s defense. The district court would have to order that the instructions be offered (and could decline), but I believe it would be persuasive to the judge in deciding to offer them to have this statutory language. The possible instructions are:

(1) the physician may not be found negligent if, using his/her medical judgment, the physician selects, with the patient, a medically acceptable course of treatment and documents in the medical record his/her rationale at the time of treatment for prescribing or not prescribing, recommending, and/or ordering a given test, procedure, treatment, consultation, or other therapeutic intervention.

(2) A physician may, further, not be found negligent because the course of treatment followed was ultimately not successful.

(3) A physician may, further, not be found negligent because the patient did not experience the desired outcome or result.

Ultimately, a jury will have to answer the question of negligence but, if accepted by the judge, these would be part of how the jury would be instructed on the law.

Please let me know if you have any questions, concerns, etc. These are just my initial thoughts in line with our discussion. I am open to any changes. I included Peter so he could provide his thoughts as well.

I also spoke with Senator Janna Taylor about the defensive medicine bill from last session and a possible revision for this session. She told legislative services to go ahead with the former HB 405 so it is drafted and ready to pick up. She said she can leave it there and not pick it up while the MMA decides the course of action. She is willing to discuss an alternative bill. She also had some questions about the confidentiality of the MMLP and consent clauses in malpractice insurance. 1

Talk soon.

Thanks! Kiely

From: Jean Branscum [mailto:[email protected]] Sent: Monday, December 17, 2012 7:42 PM To: Kiely Keane; Carter E. Beck, M.D.; Carter E. Beck, M.D./Kathleen Ryan; Shaun J. Gillis, M.D.; Peter J. Stokstad ([email protected]) Subject: FW: Legislation samples

I reached out to the AMA after our phone meeting last week and asked about safe harbors and what other states might have put in place. Attached is what I got back which seems helpful.

Jean Branscum, Executive Vice President Montana Medical Association 2021 Eleventh Avenue Helena, Montana 59601 406/443-4000 ext. 105 Toll free (intrastate): 877/443-4000 406/439-5960 (cell); 406/443-4042(fax) [email protected] From: Kristin Schleiter [mailto:[email protected]] Sent: Friday, December 14, 2012 9:39 AM To: Jean Branscum Cc: Daniel Eller Subject: RE: Legislation samples

Hi Jean!

Great timing – I was just about to write you an email about some prefiled med mal bills, particularly the safe harbor for EBM. Our statement of principles is attached, as information. I’d be happy to help, and support (eg, letter) wherever you think it would help!

Kristin

This email has been scanned for email related threats and delivered safely by Mimecast. For more information please visit http://www.mimecast.com

2 63rd Legislature LC0670.01

1 BILL NO.

2 INTRODUCED BY (Primary Sponsor) 3

4 A BILL FOR AN ACT ENTITLED: "AN ACT CHANGING THE STATUTE OF LIMITATIONS FOR MEDICAL

5 MALPRACTICE CLAIMS FROM 3 YEARS TO 2 YEARS; AMENDING SECTION 27-2-205, MCA; AND

6 PROVIDING AN IMMEDIATE EFFECTIVE DATE AND AN APPLICABILITY DATE."

8 WHEREAS, the provision of medical services to Montana residents is imperative to their health and

9 happiness; and

10 WHEREAS, it is increasingly difficult for Montana communities to attract and retain qualified medical

11 providers; and

12 WHEREAS, the acquisition of reasonably priced medical malpractice insurance coverage is a factor in

13 attracting medical providers to Montana and in retaining them; and

14 WHEREAS, the Legislature has determined that a shortage of health care providers in the state and an

15 inability to attract health care providers to the state would pose a serious threat to the health, welfare, and safety

16 of Montanans; and

17 WHEREAS, the number of insurance carriers that provide liability insurance for hospitals, physicians, and

18 dentists has declined significantly in the past decade; and

19 WHEREAS, insurance premiums for liability insurance for health care providers have historically forced

20 physicians and other providers in Montana to consider either curtailing certain medical services or, in the

21 alternative, relocating to other states where premiums are stabilized; and

22 WHEREAS, Montana has a compelling state interest in ensuring that Montana residents receive quality

23 and reasonably priced health care; and

24 WHEREAS, recently enacted federal health care reform failed to address tort reform measures, defensive

25 medicine costs, and abusive litigation practices; and

26 WHEREAS, all of Montana's neighboring states (Idaho, Wyoming, South Dakota, and North Dakota) have

27 a 2-year or less statute of limitations for medical malpractice actions; and

28 WHEREAS, the Legislature declares that it is the policy of the State of Montana to attempt to attract and

29 retain qualified health care providers to care for the residents of Montana and that reducing the statute of

30 limitations to 2 years will put Montana on a level playing field with its neighboring states.

- 1 - Authorized Print Version - LC 670 63rd Legislature LC0670.01

2 BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF MONTANA:

4 Section 1. Section 27-2-205, MCA, is amended to read:

5 "27-2-205. Actions for medical malpractice. (1) Action in tort or contract for injury or death against a

6 physician or surgeon, dentist, registered nurse, nursing home or hospital administrator, dispensing optician,

7 optometrist, licensed physical therapist, podiatrist, psychologist, osteopath, chiropractor, clinical laboratory

8 bioanalyst, clinical laboratory technologist, pharmacist, veterinarian, a licensed hospital or long-term care facility,

9 or licensed medical professional corporation, based upon alleged professional negligence or for rendering

10 professional services without consent or for an act, error, or omission, must, except as provided in subsection

11 (2), be commenced within 3 2 years after the date of injury or within 3 2 years after the plaintiff discovers or

12 through the use of reasonable diligence should have discovered the injury, whichever occurs last, but in no case

13 may an action be commenced after 5 years from the date of injury. However, this time limitation is tolled for any

14 period during which there has been a failure to disclose any act, error, or omission upon which an action is based

15 and that is known to the defendant or through the use of reasonable diligence subsequent to the act, error, or

16 omission would have been known to the defendant.

17 (2) Notwithstanding the provisions of 27-2-401, in an action for death or injury of a minor who was under

18 the age of 4 on the date of the minor's injury, the period of limitations in subsection (1) begins to run when the

19 minor reaches the minor's eighth birthday or dies, whichever occurs first, and the time for commencement of the

20 action is tolled during any period during which the minor does not reside with a parent or guardian."

22 NEW SECTION. Section 2. Effective date. [This act] is effective on passage and approval.

24 NEW SECTION. Section 3. Applicability. [This act] applies to civil actions filed on or after July 1, 2013.

25 - END -

- 2 - Authorized Print Version - LC 670 62nd Legislature HB0396.01

1 HOUSE BILL NO. 396

2 INTRODUCED BY S. SMALL

4 A BILL FOR AN ACT ENTITLED: "AN ACT CREATING THE HEALTH CARE PROVIDER TRANSPARENCY

5 ACT; SPECIFYING NOTIFICATION TERMS AND EXEMPTIONS TO THE NOTIFICATION; AND DESCRIBING

6 VIOLATIONS AS AN UNFAIR TRADE PRACTICE."

8 WHEREAS, an informed health care consumer needs not only the information allowed for in Title 50,

9 chapter 4, regarding certain health care cost information from health care providers and insurers but information

10 on health care quality, including treatment options and the potential efficacy of those treatments; and

11 WHEREAS, quality health care also depends in part on a consumer's informed choice of health care

12 provider, a choice made more difficult by advertising that often includes a dizzying array of initials, titles, or

13 degrees all of which may incorporate the term doctor, doctorate, medical, medicine, or physician in a way that

14 may mislead a consumer into paying for possibly inappropriate care; and

15 WHEREAS, a 2008 survey by the American Medical Association revealed general public confusion

16 regarding whether certain health care providers were also medical doctors, with patients wrongly responding that

17 a chiropractor, a doctor of nursing, a psychologist, an optometrist, and a podiatrist were medical doctors; and

18 WHEREAS, substantial differences exist among health care professionals in their training and

19 qualifications for correctly detecting, diagnosing, preventing, and treating illness or health conditions.

21 BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF MONTANA:

23 NEW SECTION. Section 1. Short title. [Sections 1 through 5] may be cited as the "Health Care

24 Provider Transparency Act".

26 NEW SECTION. Section 2. Purpose. The legislature finds that truthful representation from health care

27 providers and their representative organizations assist the public in making informed decisions regarding health

28 care expenditures and the choice of health care providers. The legislature further finds that there is a compelling

29 state interest in promoting the availability of prompt and understandable information to help patients make health

30 care choices.

- 1 - Authorized Print Version - HB 396 62nd Legislature HB0396.01

2 NEW SECTION. Section 3. Definitions. As used in [sections 1 through 5], the following definitions

3 apply:

4 (1) "Advertisement" or "advertising" means a commercial message in any medium, whether print,

5 electronic, or verbal, that names a health care provider in relation to a practice, profession, or institution that

6 involves health care services, whether the health care provider is employed, volunteers, or contracts to provide

7 the health care services. Advertising includes but is not limited to business cards, letterhead stationery, patient

8 brochures, websites, e-mail, audio, and video.

9 (2) "Deceptive or misleading", when used in describing advertising, includes but is not limited to an

10 advertisement for health care services that misstates, falsely describes, or falsely represents the health care

11 provider's degree, skills, training, expertise, education, board certification, or licensure.

12 (3) "Health care provider" means a person who is licensed, certified, or otherwise authorized by the laws

13 of this state to provide health care in the ordinary course of business or practice of a profession.

15 NEW SECTION. Section 4. Requirements. (1) Except as provided in subsections (4) and (5), a health

16 care provider shall identify in any advertisement to provide health care services:

17 (a) the type of degree or license held by the health care provider; and

18 (b) a title or designation authorized by the health care provider's license or the examination designations

19 required for licensure.

20 (2) An advertisement under this section may not contain deceptive or misleading information.

21 (3) In a practice setting, a health care provider shall affirmatively communicate the health care provider's

22 specific licensure by:

23 (a) during all patient encounters, wearing a nametag that clearly identifies the professional degree held

24 by the health care provider unless precluded by adopted sterilization or isolation protocols. The nametag must

25 be of sufficient size and be worn in a conspicuous manner so that the nametag is visible and apparent.

26 (b) in an office in which the health care provider sees current or prospective patients, displaying a posted

27 notice that clearly identifies the type of degree or license held by the health care provider. The notice must be of

28 sufficient size to be visible and apparent to a current or prospective patient. A health care provider who practices

29 in more than one office shall follow the procedures under this subsection (3) in each office.

30 (c) using only the degree titles or initials authorized by the health care provider's license and any

- 2 - Authorized Print Version - HB 396 62nd Legislature HB0396.01

1 examination designation required for licensure.

2 (4) A health care provider working in a nonpatient practice setting who does not have any direct

3 interactions with patients is not subject to the provisions of subsections (1) through (3).

4 (5) An aide to a health care provider or a student, intern, or resident working in a health care specialty

5 shall wear a nametag that clearly identifies the individual's name and position unless otherwise provided by the

6 licensing provisions for the health care provider responsible for the aide, student, intern, or resident.

8 NEW SECTION. Section 5. Violations. Failure to comply with any provision of [sections 1 through 5]

9 is:

10 (1) unprofessional conduct and is subject to disciplinary action by the board regulating the licensee's

11 health care profession or by the department of labor and industry for professions without a regulatory board; and

12 (2) a violation of 30-14-103, for which the penalty provisions of the Montana Unfair Trade Practices and

13 Consumer Protection Act of 1973 apply.

15 NEW SECTION. Section 6. Codification instruction. [Sections 1 through 5] are intended to be codified

16 as an integral part of Title 37, chapter 2, and the provisions of Title 37, chapter 2, apply to [sections 1 through 5].

17 - END -

- 3 - Authorized Print Version - HB 396 THE MONTANA MEDICAID PROGRAM

Montana Department of Public Health and Human Services Report to the 2011 Legislature

State Fiscal Years 2009/2010

DEPARTMENT OF PUBLIC HEALTH AND HUMAN SERVICES

Brian Schweitzer Anna Whiting Sorrell GOVERNOR DIRECTOR

STATE OF MONTANA www.dphhs.mt.gov PO BOX 4210 HELENA, MT 59604-4210 (406) 444-5622 FAX (406) 444-1970

December 22, 2010

Dear Legislators:

I am pleased to provide the Montana Medicaid Program Report to the 2011 Legislature, as is required by Montana law.

The Montana Medicaid program helps Montanans all across this state - from border to border – to be more self sufficient. Medicaid is a joint federal-state program that pays for a broad range of medically necessary health care and long-term care services for certain low income populations. DPHHS administers the program in a partnership with the federal Centers for Medicare and Medicaid Services (CMS).

We have prepared this overview to provide basic information for your use as a starting point in understanding the Medicaid program. The report outlines the eligibility process, including resource limit requirements, and the actual enrollment of and benefits paid to the separate eligible populations. Eligibility is primarily determined by staff in Offices of Public Assistance throughout the state in most counties, who work very hard to ensure that the determination process runs as efficiently as possible.

The overview explains Medicaid benefits; enrollment and expenditures by county; the number of participating providers and claims they submitted; and a summary of the rate setting process. There is also a section on waivers. DPHHS has requested several Medicaid waivers from CMS in order to better customize services for key populations. These waivers have allowed us to dramatically improve the lives of people participating in the Montana Medicaid program, while often times providing the most cost efficient service in their homes. Featured in the report is the Children’s Autism Waiver which was approved in January 2009. This waiver serves Montana children ages 15 months through 7 years old with autism and adaptive behavior deficits. Autism impacts families statewide, and this waiver has made a difference in Montana, while saving thousands of dollars.

Tribal activities is another key piece of this report. DPHHS contracts with Indian Health Services and Tribal health departments for services in many Tribal communities. In addition to services, the Medicaid Administrative Match Program (MAM) continues to flourish. MAM was created to reimburse contracted Montana Tribes with federal funds for allowable administrative costs related to Medicaid State Plan or waiver services.

This letter does not mention all the information contained in the report. Thank you for taking the time to better understand the Medicaid program by reading this in its entirety. If you have any questions, or if we can provide additional information, please feel free to contact me at (406) 444-5622, or Mary Dalton, State Medicaid Director, at 444-4084.

Sincerely,

Anna Whiting Sorrell, Director

The Montana Medicaid Program Report to the 2011 Legislature

Contents: Program Overview 3

Eligibility 3

Benefits 12

Waivers 14

Indian Health Service 19

Tribal Activities 19

Providers and Claims Processing 29

Rate Setting Process 30

Cost Containment Measures 31

Expenditure Analysis 34

Appendixes Chronology of Major Events in Medicaid 37

Glossary of Acronyms 45

The Montana Medicaid Program Report to the 2011 Legislature

The Montana Medicaid Program is authorized under 53-6-101, Montana Codes Annotated, and Article XII, Section 3 of the Montana Constitution. The Department of Public Health and Human Services (DPHHS) administers the program.

Program Mission:

To assure that necessary medical care is available to all eligible Montanans within available funding resources.

Basic Objectives:

• Promote the maintenance of good health by Medicaid eligible persons

• Assure that Medicaid eligible persons have access to necessary medical care

• Assure that the quality of care meets acceptable standards

• Promote the appropriate use of services by Medicaid eligible persons

• Assure that services are provided in the most cost effective manner

• Assure that only medically necessary care is provided

• Assure that the Medicaid program is operated within legislative appropriation

• Assure that prompt and accurate payments are made to providers

• Assure that accurate Medicaid program and financial information is available for management on a timely basis

• Assure that confidentiality and privacy of client information is maintained at all times

• Promote the appropriate utilization of preventive services

The Montana Medicaid Program Report to the 2011 Legislature

MEDICAID PROGRAM OVERVIEW

The Montana Medicaid program is a joint federal-state program. The State administers the program in partnership with the federal Centers for Medicare and Medicaid Services (CMS). States are required to provide the same amount, duration, and scope of services to all people who receive a Medicaid benefit unless they have a waiver. The State is responsible for determining eligibility for low-income populations including pregnant women, children, individuals with disabilities and the elderly. As a general rule, the Montana Medicaid program has flexibility to: 1) design our own eligibility package; 2) design our own benefit package; and 3) determine provider reimbursement within certain guidelines established by CMS. The Montana Medicaid benefits package meets the federal requirements.

Medicaid services are funded by a combination of federal and state (and in some situations, local) funds. In Montana, the matching rate is approximately 67% federal and 33% state funds. Simply stated, if DPHHS receives 33 cents in general funds, the 33 cents becomes a Medicaid dollar. Some Medicaid services receive an enhanced federal match rate such as services provided in Indian Health Service Facilities at 100% federal dollars; for family planning services at 90% federal; and services through the breast and cervical cancer program at 78%. In addition, administrative costs of the State are matched at 50% and data systems are matched at 75%.

MEDICAID ELIGIBILITY

The rules governing Medicaid eligibility changed with the passage of the Affordable Care Act. As of March 2010, a state can no longer decrease eligibility for Medicaid below the level in place as of that date. Montana can still choose to add eligibility categories but we cannot decrease either the number of categories/groups that we cover nor can we decrease the level of poverty that we provide coverage for.

These are the different groups/populations that Montana provides Medicaid coverage for:

Children – Medicaid is the largest provider of health care coverage for children in the State of Montana. During State Fiscal Year 2009, the average number of children enrolled in Medicaid each month was 47,952. For State Fiscal Year 2010 the average for each month was 56,992, with 64,099 children enrolled in the month of June 2010. Children are primarily covered by Medicaid under one of the following three programs:

 Healthy Montana Kids Plus - Children up to the age of 19 in families with countable income equal to or less than 133% of the Federal Poverty Level (FPL). There is no resource test for these children.

The Montana Medicaid Program Report to the 2011 Legislature

 Infants - Children born to women who are receiving Medicaid at the time of birth automatically qualify for Medicaid coverage through the month of their first birthday. There is no income or resource test for this coverage.

 Subsidized Adoption and Foster Care - Children who are eligible for an adoption subsidy through the Department are automatically eligible for Medicaid coverage. This coverage can continue through the month of the child’s 21st birthday. Children who are placed into licensed foster care homes by the Child and Family Services Division are eligible for Medicaid.

Pregnant Women – Medicaid must be provided to eligible pregnant women with countable income equal to or less than 150% FPL (increased from 133% FPL in July 2007) and countable resources that do not exceed $3000. The coverage extends for two months beyond the birth of their child.

2010 Federal Poverty Levels & Gross Monthly Income

Family Size 150% FPL 133% FPL 100% FPL 1 $1,354 $1,200 $903 2 $1,821 $1,615 $1,214 3 $2,289 $2,029 $1,526 4 $2,756 $2,444 $1,838

Families with Dependent Children – Parents or related caretakers (grandparents, aunts/uncles, etc.) whose countable income is below the Family Medicaid income level and whose countable resources do not exceed $3000 may receive Medicaid. TANF cash assistance eligibility must be determined separately from Medicaid.

Family-Transitional Medicaid - Under certain conditions, families are eligible for up to 12 months of extended Medicaid coverage after their eligibility for Section 1931 Medicaid coverage ends due to new or increased earned income. This coverage, called Family-Transitional Medicaid, is not dependent on income, and there is no resource limit. The family must meet all other eligibility criteria for the entire 12 months.

Monthly Income Limit Family Size Transitional SFY 2007 1 $1,574 2 $2,111 3 $2,647 4 $3,184

The Montana Medicaid Program Report to the 2011 Legislature

Aged – Individuals who are age 65 or older and whose countable income is within allowable guidelines and whose resources do not exceed $2000 for an individual or $3000 for a couple may be eligible for Medicaid.

Blind/Disabled – Individuals who have been determined to be blind or disabled using Social Security criteria, and whose income is within allowable limits and whose resources do not exceed $2000 for an individual or $3000 for a couple may be eligible for Medicaid.

Income limits for the aged, blind and disabled populations are $674 per month for an individual and $1011 for a couple.

People Who Are Aged, Blind, or Disabled and Receiving Supplemental Security Income (SSI) Low income aged, blind, and disabled persons make up a large group within the Medicaid program. Many aged, blind, and disabled clients live alone and struggle to maintain independence despite health conditions requiring regular medical attention. Medicaid is critical to maintaining their access to medical care and thereby supports a higher level of independence, often reducing the need for more costly medical and support services.

Persons who are aged, blind, or disabled and whose income and resources are below federal Supplemental Security Income (SSI) limits may receive both SSI cash benefits and Medicaid, or they may receive Medicaid only. The Department’s 2010 Disability Determination Bureau determines disability status Family Resource Monthly SSI for the SSI program. Aged, blind, or disabled persons with Size Limit Income Limit income above the SSI standards may be eligible for Medicaid under the medically needy program. 1 $2,000 $674 2 $3,000 $1,011

Enrollment and Expenditure Comparison Aged and Blind / Disabled

Note that graphs above do not include Medicare Savings Plan Only clients or expenditures.

The Montana Medicaid Program Report to the 2011 Legislature

Breast and Cervical Cancer Treatment - This is a program for women who are diagnosed with breast or cervical cancer or a precancerous condition of the breast or cervix. To be eligible, a woman must be under 65 years old, not have insurance that is considered to be ‘creditable coverage,’ meet citizenship or qualified alien requirements, be a Montana resident, and have been screened through the Montana Breast and Cervical Health Program. Countable income cannot exceed 200% of the Federal Poverty Level and there is no resource test.

Montana Medicaid for Workers with Disabilities (MWD) – Montana implemented MWD effective July 1, 2010, based on provisions of the Balanced Budget Act of 1997 (BBA). MWD allows certain SSDI and former SSI recipients who are not financially eligible for Medicaid to pay affordable premiums for Medicaid coverage. Individuals must be employed, either through an employer or self-employed, to be considered for this program.

Medically Needy – This is coverage for certain individuals or families whose income exceeds the program standards but who have a significant medical need. The individual or family pays the difference between their countable income and the Medically Needy Income Level toward medical expenses each month. This difference is called an incurment or spenddown and can be met by making cash payments to the Department, incurring medical bills or a combination of the two. The resource limit is $2000 for an individual, and $3000 for a couple or family. In Montana, the aged, blind, disabled, children and pregnant women arecovered under the medically needy program.

State Fiscal Year 2010 Limits for Medically Needy Monthly Income Family Size Resource Limit Limit 1 $2,000/$3,000** $525 2 $3,000 $525 3 $3,000 $658 4 $3,000 $792 5 $3,000 $925 6 $3,000 $1,058 7 $3,000 $1,192 8 $3,000 $1,317 9 $3,000 $1,383 10 $3,000 $1,450 **$2,000 for aged, blind, or disabled individuals, $3,000 for children, pregnant women and for aged, blind, or disabled couples.

The Montana Medicaid Program Report to the 2011 Legislature

Comparison between Categorically Needy and Medically Needy

Note that graphs above do not include Medicare Savings Plan Only clients or expenditures.

The Montana Medicaid Program Report to the 2011 Legislature

The column in the above chart “% of Montana Population” shows the percentage of Montana population for that beneficiary characteristic. For example 50% of Montana’s population is female, but 56% of the total Medicaid population in Montana is female.

The Montana Medicaid Program Report to the 2011 Legislature

SFY 2009 Enrollment and Expenditures by Major Aid Category 100%

90% 20.2%

80%

55.1% 13.3% 70%

60%

50%

47.0% 40% 14.0%

30%

20% 23.4%

10% 19.4% 7.5% 0% Enrollment Expenditures Aged Blind and Disabled Adults Children

The chart shows Medicaid enrollment in 2009 by aid category. The Aged and Disabled are a relatively small percentage of the entire Medicaid population, but account for a high percentage of the Medicaid funds expended. Conversely, Children represent slightly more than half of the Medicaid population but account for approximately one-fifth of the cost.

SFY 2009 Enrollment and Expenditures by Major Aid Category Average Monthly Percent of Percent of Aid Category Enrollment Enrollment Expenditures Expenditures Aged 6,126 7.5% $162,599,916 19.4% Blind and Disabled 19,059 23.4% $393,322,855 47.0% Adults 11,433 14.0% $111,604,852 13.3% Children 44,979 55.1% $169,336,452 20.2% Total 81,597 100% $836,864,075 100%

The Montana Medicaid Program Report to the 2011 Legislature

MEDICAID BENEFITS

The Montana Medicaid benefits package meets federal guidelines. Medicaid benefits are divided into two classes. Federal law requires that adults eligible for Medicaid are entitled to the following services unless waived under Section 1115 of the Social Security Act. These are referred to as mandatory services and include:  Physician & Nurse Practitioner  Nurse Midwife  Medical & Surgical Service of a Dentist  Laboratory and X-ray  Inpatient Hospital (excluding inpatient services in institutions for mental disease)  Outpatient Hospital  Federally Qualified Health Centers  Rural Health Clinics  Family Planning  Early and Periodic Screening, Diagnosis and Treatment (EPSDT)  Nursing Facility  Home Health  Durable Medical Equipment

States may elect to cover other optional services. Montana has chosen to cover a number of other cost-effective optional services including, but not limited to, the following:  Outpatient Drugs  Dental and Denturist Services  Comprehensive Mental Health Services  Ambulance  Physical & Occupational Therapies and Speech Language Pathology  Transportation & Per Diem  Home & Community Based Services  Eyeglasses & Optometry  Personal Assistance Services  Targeted Case Management  Podiatry

There is an exception to a state’s ability to decide which optional services it will cover. Early and Periodic Screening, Diagnostic and Treatment (EPSDT) services must be covered under the Medicaid program for categorically needy individuals under age 21. The EPSDT benefit is optional for the medically needy population. However, if the EPSDT benefit is elected for the medically needy population, it must be made available to all Medicaid eligible individuals under age 21.

Under the EPSDT regulations, a state must cover all medically necessary services available under the federal Medicaid program to treat or ameliorate a defect, physical and mental illness,

The Montana Medicaid Program Report to the 2011 Legislature or a condition identified by a screen. This is true of whether the service or item is otherwise included in the State Medicaid plan.

The following table outlines the services reimbursed by the Montana Medicaid Program:

Montana Medicaid and HMK Plus Medicaid Covered Services

The description of services presented here is a guide and not a contract to provide medical care. Administrative rules of Montana, Title 37, Chapters 81 through 88, govern access and payment of services. Categorically and Medically Needy: Family Related Children and Adult Basic Adults Alcohol, drug treatment: hospital inpatient, outpatient, non-hospital 1 1 Anesthesia 1 1 Audiology 1, 2 3 Case management—targeted 1, 2 1, 2 Chiropractic 5 7 Circumcision 1 1 Clinic: IHS, FQHC, RHC, public health 1 1 Dental, denturist 1 3 Developmental disability 1, 6 1, 6 Dialysis, outpatient and training for self-dialysis 1 1 Durable medical equipment 1, 2 3 EPSDT: Early and Periodic Screening, Diagnosis, and Treatment 5 7 Eye glasses, eye exams, optician 1, 2 3 Family planning services, birth control 1 1 Group home care 5, 2 7 Hearing aids, hearing exams, audiology 1, 2 3 Home, community based, home health 4 7 Home infusion 1 7 Hospital: inpatient, outpatient, emergency department, urgent care, birth center, transitional 1 1 Immunizations 1 1 Interpreter 1 1 Laboratory, imaging, X ray 1 1 Long term care, nursing home, private duty nursing, hospice 1, 6 1, 6 Mental health 1 1 Nurse advice line 1 1 Nutrition counseling 1, 2 1, 2 Obstetric, pregnancy, child birth 1 1 Orthodontia 5 7 Personal assistant 1, 2 7 Pharmacy: prescription and over-the-counter 1, 2 1, 2 Podiatry 1 1 School-based 5, 2 7 Surgery 1 1 Therapies: occupational, physical, speech 1, 2 1, 2 Therapy: respiratory 5 7 Tobacco cessation drugs and counseling 1 1 Transplants 1 1 Transportation, including ambulance for emergency 1, 2 1, 2

1. Covered. 2. Limits may apply 3. Usually not covered. Services may be authorized in emergency situations, if essential for employment, or for some medical conditions. 4. Home and community based services waiver may include coverage for these services for individuals covered by the waiver. 5. Covered for children only. 6. Level of care requirements. 7. Not covered

The Montana Medicaid Program Report to the 2011 Legislature

MEDICAID WAIVERS

State Medicaid programs may request from the Centers for Medicare and Medicaid Services (CMS) a waiver(s) of certain federal Medicaid requirements that are found in the Social Security Act. A common public misconception is that any portion of the Medicaid program can be waived by CMS. In reality, only certain requirements such as statewideness, freedom of choice, and comparability of eligibility and/or benefits can be waived. Waivers are also limited in that they must always be cost neutral to the federal government.

The following is a brief description of the three types of waivers that Montana operates:

 Section 1115 waivers authorize experimental, pilot, or demonstration project(s). The Secretary of Health and Human Services has complete discretion as to whether an 1115 waiver is granted. This kind of waiver is granted only when the Secretary feels that a state will demonstrate something that is of interest in promoting the objectives of the Medicaid program. This waiver can be used to expand eligibility for Medicaid. The number and type of services can either be limited or expanded under this type of waiver.

 Section 1915(b) waivers allow States to waive statewideness, comparability of services, and freedom of choice. 1915(b) waivers cannot be used for eligibility expansions. There are four 1915(b) Freedom of Choice Waivers available: (b)(1) mandates Medicaid enrollment into managed care (b)(2) utilize a “central broker” (b)(3) uses cost savings to provide additional services (b)(4) limits number of providers for services

 Section 1915(c) waivers are referred to as Medicaid Home and Community-Based Services (HCBS) waivers. They are alternatives to providing long-term care in an institutional setting (Medicaid defines an institution as a nursing facilities, hospital, or Intermediate Care Facilities for the Mentally Retarded. A 1915(c) waiver enables a state to pay for an expanded array of medical care and support services that assist people to continue to live in their homes and/or communities. These waivers also allow a state, if it wishes, to count only the income of the affected individual rather than that of the whole family when determining eligibility. States do have the discretion to provide a combination 1915(b) and 1915(c) waiver.

Montana operates a number of different waivers in order to better customize services for key populations. A brief description of our current waivers is found on the next several pages:

The Montana Medicaid Program Report to the 2011 Legislature

1115 Basic Medicaid Waiver – Health Resources and Addictive and Mental Disorders Division – Approved in 1996, this waiver offers a limited Basic Medicaid benefit package of optional services to Medicaid eligible adults, age 21 to 64. Participants cannot be pregnant or disabled, with the exception that is noted below. Participants receive a basic package of Medicaid benefits that excludes: audiology, dental and denturist, durable medical equipment, eyeglasses, optometry and ophthalmology for routine eye exams, personal care services, home infusion and hearing aids. DPHHS recognizes there may be situations where these excluded services are necessary in an emergency situation, when they prevent more costly care, or when they are essential to obtain or maintain employment. In these instances, excluded services may be provided at the State’s discretion. Examples of discretionary circumstances include coverage for emergency dental situations, medical conditions of the eye, which include but are not limited to annual dilated eye exams for individuals with diabetes or other medical conditions, and certain medical supplies such as diabetic supplies, prosthetic devices and oxygen.

Effective December 2010, the state received approval for the long-awaited “HIFA” waiver. CMS approved the addition of up to 800 individuals who previously qualified for the state funded Mental Health Services Plan. Eligible participants must be at least 18 years of age and have schizophrenia or bipolar disorder. Under the “MHSP” portion of the Basic Waiver, individuals will now be eligible to receive medical care as well as psychiatric services. Federal savings generated from the Basic Medicaid Waiver Able Bodied population will be used to fund the federal benefit costs.

1915(b) Waiver Passport to Health - Health Resources Division – Passport to Health is the primary care case management program in which most Medicaid and HMK Plus eligible individuals are enrolled. A client chooses a primary care provider who delivers all medical services or furnishes referrals for other medically-necessary care. Care management offered under the waiver enhances care while reducing costs to Medicaid and HMK Plus by minimizing ineffective or inappropriate medical care.

The waiver is operated in all 56 counties and involves 71 percent of all Montana Medicaid clients. Quality, access to care, and health outcomes are continuously monitored, tracked, and reported. Clients and providers report satisfaction with these care management programs that document annual cost savings to Medicaid.

This waiver also includes Team Care, a program for individuals identified with inappropriate or excessive utilization of health care services. Individuals are enrolled in Team Care for at least 24 months and receive services from one pharmacy and one medical provider.

1915 (b) Waiver – Health Improvement Program - Health Resources Division – The Health Improvement Program is an enhanced primary care case management program, administered in partnership with community health centers. High-cost, high-risk Medicaid and HMK Plus clients are identified by Medicaid through the use of predictive modeling software and provider referrals. Care managers and case managers employed by community health centers provide in- person and telephonic health care management services to improve health outcomes and reduce costs.

The Montana Medicaid Program Report to the 2011 Legislature

This waiver includes Nurse First, a 24/7 nurse advice line available to all Medicaid and HMK Plus clients. The advice line is operated by a vendor and directs callers to the most appropriate level of care: self-care, provider visit, or emergency department visit.

1915 (c) HCBS Children’s Autism Waiver - Developmental Services Division - CMS approved the waiver on January 1, 2009 to serve Montana children ages of 15 months through 7 years old with autism and adaptive behavior deficits. This children’s autism waiver provides early intervention based upon applied behavioral analysis (ABA) training models. Children receive about 20 hours of intensive training per week that is focused on improving skills in the areas of communication, socialization, academics, and activities of daily living while reducing maladaptive behaviors. The waiver serves 50 children per year. Children may be served for a maximum of three years. Seven agencies across the state provide program design and training, case management services, and other supports to enrolled children and their families.

Medicaid reimbursement is projected to be $2,150,000 at full enrollment of 50 children for an entire year. Approximately 52 children (under the age of 5) are currently on the waiting list for Children’s Autism Waiver services.

1915 (c) HCBS Comprehensive Services Waiver for Individuals with Developmental Disabilities - Developmental Services Division - This waiver for people with Developmental Disabilities (DD) was initiated in 1981. It was one of the first waivers in the country to provide community based services to persons needing DD services. It serves 344 children and 1659 adults. The majority of reimbursement for adults goes to group home, supported living, work/day, and transportation services. Children’s services include caregiver training and support and children’s case management. Specialized services available under this waiver include the following: psychological services, board certified behavioral analyst (BCBA) consultation, personal care, homemaker, respite, occupational therapy, physical therapy, speech therapy, environmental modifications, nutritional evaluations, private duty nursing, meals, personal emergency response systems (PERS), and respiratory services. The average cost per person served in this waiver was $37,382 in SFY09.

1915 (c) HCBS Community Supports Waiver - Developmental Services Division - The waiver was initially approved by CMS in 2001. Many persons in this waiver live at home. Services are often purchased to help unpaid primary care givers better meet the needs of an adult family member with a developmental disability. Waiver services include: homemaker, personal care, respite, residential habilitation, day habilitation, prevocational training, supported employment, environmental modifications, transportation, specialized medical and adaptive equipment, adult companion, private duty nursing, social/leisure/recreation opportunities, personal emergency response systems (PERS), health/safety supports and educational services. This waiver served 271 adults (age 18 years and up. Cost plans are capped at $7,800/person.

The Montana Medicaid Program Report to the 2011 Legislature

1915(c) HCBS Elderly and Physically Disabled Waiver - Senior and Long Term Care Division - The Elderly (age 65 and older) and Physically Disabled waiver started in 1982. The program recognizes that many individuals at risk of being placed in institutional settings can be cared for in their homes and communities, preserving their independence and ties to family and friends, at a cost no higher than that of institutional care. To qualify a person must be financially eligible for Medicaid and meet the program’s level of care requirements in a nursing facility or hospital. The Department contracts with case management teams to develop an individual plan of care in conjunction with the consumer. Waiver services include case management, respite, adult residential care, specialized services for those with traumatic brain injuries, environmental modifications, adult day health and personal response systems. In 2010 more than 2,300 individuals received HCBS funded services.

1915(c) HCBS Big Sky Bonanza Waiver - Senior and Long Term Care Division - In addition to the HCBS waiver program, the SLTC Division developed a new waiver, called the Big Sky Bonanza (BSB) waiver in 2006. The BSB waiver is similar to the HCBS waiver program, but provides more flexibility and choice through increased consumer direction. The BSB waiver is now available in forty-one counties and serves 24 individuals. This waiver will be expanded to the remainder of the state by the end of 2011.

The Montana Medicaid Program Report to the 2011 Legislature

1915( c) HCBS Severe Disabling Mental Illness Waiver (SDMI) - Additive and Mental Disorders Division - Implemented in December 2006, this waiver allows Medicaid reimbursement for community-based services for individuals who are 18 years of age or older with SDMI who meet certain criteria for nursing home level of care. The waiver’s 155 slots are distributed among four geographic core areas including Billings, Great Falls, Missoula and Butte plus surrounding counties for each. In each site, services are coordinated by a team that is made up of a registered nurse and a social worker. Services provided to persons enrolled in the SDMI waiver include case management, wellness recovery action plan (WRAP), illness management and recovery program, non-medical transportation, specialized medical equipment and supplies, personal emergency response, adult day care, respite, private duty nursing, day habilitation, prevocational services, supportive employment, additional occupational therapy, adult residential care, habilitation aide, chemical dependency counseling, residential and day habilitation, supportive living, personal assistance and specially trained attendants, and psychosocial rehabilitation.

1915(c ) Look Alike - Alternative to PRTF Demonstration Grant for Youth with Serious Emotional Disturbance (SED) - Developmental Services Division - Montana was one of ten states awarded the Psychiatric Residential Treatment Facility (Alternatives to PRTF) Demonstration Grant through the Deficit Reduction Act of 2005. CMS approved the five year grant effective October 1, 2007, with the possibility of the grant transforming to a HCBS Waiver at the end of the fifth year. This PRTF Waiver for Youth with SED is not available statewide. Services are available in Yellowstone Carbon, Stillwater, Musselshell, Big Horn, Missoula, Ravalli, Lewis and Clark, Jefferson, Broadwater, and Cascade counties.

A youth must be age 6 through 17 and require the level of care for a Psychiatric Residential Treatment Facility to qualify for services. Since the grant began in 2007, forty-eight youth have been served.

Grant services are individually tailored to meet the needs of the youth served and include: consultative clinical and therapeutic services; customized goods and services; education and support services; home-based therapist; non-medical transportation; respite care; family support specialist services; caregiver peer-to-peer support specialist services; and wraparound facilitation services.

The Montana Medicaid Program Report to the 2011 Legislature

Indian Health Service (IHS)

The Montana Medicaid Program provides 100% federal reimbursement for covered medical services to all Medicaid-eligible American Indians who receive those services through an Indian Health Service unit or Tribal health department. By law, the Medicaid program acts as the “pass through” agency for these services. Medicaid reimburses outpatient IHS services on an encounter basis and pays for inpatient services using a per diem payment.

Reimbursed expenditures to (IHS) facilities:

Tribal Activities

Many Native American people are eligible for both IHS and Medicaid services. Other Native American people are only eligible for Medicaid. In either of these circumstances, Medicaid reimburses tribal health department for care provided. Browning, Crow Agency, and Harlem provide both inpatient and outpatient services. Outpatient-only services are available in Lodge Grass, Poplar, Pryor, Polson, Hays, St. Ignatius, Heart Butte, Lame Deer, Wolf Point, and Arlee. Off the reservations, the Indian Health Board of Billings, the Helena Indian Alliance, the Native American Center of Great Falls, the Missoula Indian Center and the North American Indian Alliance of Butte operate and are paid as Federally Qualified Health Care Centers (FQHC) and do not receive 100 percent federal reimbursement.

Medicaid Administrative Match (MAM) MAM is a federal reimbursement program for the costs of “administrative activities” that directly support efforts to identify, and/or to enroll individuals in the Medicaid program or to assist those already enrolled in Medicaid to access benefits. Through MAM, tribes with contracts are reimbursed for allowable administrative costs directly related to the Montana State Medicaid plan or waiver service. The Montana Tribal Cost Allocation Plan gives Tribes a mechanism to seek reimbursement for Medicaid administrative activities that Tribes perform. The program, the first of its kind in the country, began July 1, 2008. Rocky Boy’s and Flathead are currently under contract. Crow, Ft. Belknap, & Northern Cheyenne all have contracts under current negotiations.

The Montana Medicaid Program Report to the 2011 Legislature

Chippewa-Cree Agreement In December 2007, the Department executed an agreement that allows the Chippewa Cree Tribe of the Rocky Boy’s Reservation to determine eligibility for Medicaid for residents on the reservation. The agreement reduces barriers/delays that may impede tribal members from obtaining Medicaid benefits and proper medical care. It was renewed in 2010.

Tribal Medicaid Specialist To help assure that mutual respect and stronger government-to-government relationships are maintained between the Department and American Indian Nations in Montana, a tribal Medicaid Specialist was authorized by the 2005 Legislature. This liaison position assists Tribes to maximize enrollment in and reimbursement by Medicaid. New Tribal consultation guidelines have been developed and are being used to oversee proper enrollment of eligible patients in Medicaid, thus opening up better treatment options and services available with the FMAP 100% federal pass-through payment rate. Better use of this pass-through rate saves both state general fund and Indian Health Service dollars.

The Montana Medicaid Program Report to the 2011 Legislature

The following charts graphically represent the data presented in the above table.

The Montana Medicaid Program Report to the 2011 Legislature

SFY 2006 to SFY 2009 Benefit Expenditures by Category 150,000,000

125,000,000

100,000,000

75,000,000

50,000,000

25,000,000

SFY 2006 SFY 2007 SFY 2008 SFY 2009 Medicaid Expenditures (Actual) Categories SFY 2006 SFY 2007 SFY 2008 SFY 2009 Inpatient Hospital (including CAHS) $ 78,303,547 $ 78,319,984 $ 79,658,259 $ 84,953,574 Outpatient Hospital (including CAHS) $ 35,393,638 $ 37,765,422 $ 39,249,889 $ 45,110,000 Hospital Utilization Fees / DSH $ 37,716,225 $ 40,465,759 $ 53,030,319 $ 61,826,736 Other Hospital & Clinical Services $ 11,787,864 $ 11,753,477 $ 11,992,953 $ 12,766,913 Physician & Psych. $ 42,149,160 $ 43,311,281 $ 43,290,531 $ 46,876,855 Other Practitioners $ 4,901,889 $ 4,785,610 $ 4,852,663 $ 5,842,707 Other Managed Care Services $ 8,271,772 $ 8,553,823 $ 7,266,542 $ 9,188,638 Drugs & Part-D Clawback $ 87,258,987 $ 70,063,317 $ 76,525,833 $ 78,963,430 Drug Rebates $ (30,537,567) $ (20,183,231) $ (24,550,872) $ (24,150,008) Dental & Denturists $ 8,453,493 $ 8,229,785 $ 10,633,911 $ 13,734,316 Durable Medical Equipment $ 10,854,321 $ 11,136,613 $ 12,000,401 $ 12,725,173 Other Acute Services $ 405,713 $ 2,453,552 $ 2,942,189 $ 4,028,362 Nursing Homes & Swing Beds $ 139,516,216 $ 141,562,834 $ 146,670,598 $ 148,878,454 Nursing Home IGT $ 6,490,490 $ 6,185,563 $ 5,428,136 $ 6,255,429 Personal Care $ 26,607,827 $ 25,908,857 $ 28,668,961 $ 33,598,041 Other SLTC Home Based Services $ 2,054,053 $ 2,861,436 $ 2,793,065 $ 3,525,183 SLTC HCBS Waiver $ 23,589,537 $ 25,362,809 $ 29,688,659 $ 32,152,846 Medicare Buy-In $ 17,963,966 $ 19,889,274 $ 21,385,058 $ 21,947,428 Children's Mental Health $ 60,347,979 $ 60,073,955 $ 59,248,226 $ 61,185,565 Adult Mental Health and Chem Dep $ 33,082,675 $ 32,480,158 $ 34,569,692 $ 40,019,113 Disability Services Waiver $ 65,944,814 $ 69,336,814 $ 78,067,644 $ 83,158,098 Indian Health Services - 100% Fed funds $ 29,156,492 $ 29,799,391 $ 29,082,729 $ 28,245,403 School Based Services - 100% Fed funds $ 9,879,620 $ 12,012,236 $ 14,429,272 $ 20,111,547 MDC & ICF Facilities - 100% Fed funds $ 12,162,410 $ 10,472,138 $ 12,395,498 $ 13,147,003 Total $ 721,755,122 $ 732,600,856 $ 779,320,156 $ 844,090,808 25

The Montana Medicaid Program Report to the 2011 Legislature

State Fiscal Year 2009 Medicaid Benefit Expenditures

Disability Services Adult Mental Health Waiver 5% 10% Indian Health Services Children's Mental Health 3% 7% School Based Services 2% Medicare Buy‐In 3% All Other SLTC HCBS Waiver 5% 4%

Personal Care 4% Inpatient Hospital $844,090,808 10%

Outpatient Hospital Nursing Homes 5% 18%

Hospital Utilization Fee 7%

Dental & Denturists 2% Physician & Psych. Drugs & Clawback 6% 9%

The Montana Medicaid Program Report to the 2011 Legislature

Montana Medicaid Growth Compared to Health Care Price Index (HCPI) and Increases in Health Insurance Premiums 12.0%

10.0% 9.7% 9.3% 8.1% 8.0% 6.8% 6.9% Change 6.1% 6.0% 5.5% 5.5% 5.5%

Percent 4.7% 4.7% 4.0% 4.4% 4.2% 4.0% 4.4% Annual

3.7% 3.2% 2.0% Average 0.0% SFY 2004 SFY 2005 SFY 2006 SFY 2007 SFY 2008 SFY 2009 Health care CPI * 4.4% 4.2% 4.0% 4.4% 3.7% 3.2% Health Insurance Premium ** 9.7% 9.3% 5.5% 5.5% 4.7% 5.5% Montana Medicaid Growth *** 6.8% 5.6% 6.9% 4.7% 8.1% 6.1% * Health Care CPI from US Department of Labor 1982 ‐ 1984 base year. ** Health insurance Premium Increases from Kaiser/HRET 2010 Annual Survey ‐ Average Annual Premiums for family coverage. *** Montana Medicaid growth isbased on the perenrollee permonth cost increases from year to year.

The Montana Medicaid Program Report to the 2011 Legislature

PROVIDERS AND CLAIMS PROCESSING

Medicaid provides services through a network of private and public providers. 15,419 providers were enrolled as Montana Medicaid providers as of August 2010. Some of these providers treat a limited number of clients and during SFY 2010, only 7419 providers actively billed Montana Medicaid.

The Department contracts with Affiliated Computer Services (ACS) to process claims for reimbursement. ACS meets the rigorous requirements established by the Centers for Medicare and Medicaid Services to be a Medicaid fiscal agent. In addition to processing over 6 million claims in SFY 2010, ACS answered 141,155 calls about Medicaid and enrolled 1,012 new providers were enrolled.

Below are the statistics on the number of claims submitted and processed in SFY 2010.

Claim Type Number Processed % of Total Paper Claims 599,582 9.6% Electronic Claims 5,676,094 90.4% Total Claims 6,275,676 100.0%

Paper Claims 9.6%

Electronic Claims 90.4%

The Montana Medicaid Program Report to the 2011 Legislature

RATE SETTING PROCESS

The Montana Medicaid Program uses several methods to establish payment rates for services. The methodology used for reimbursement varies from service to service.

Reimbursement Systems for Hospitals Montana Medicaid’s reimbursement systems include a Diagnosis Related Groups (DRG) system for inpatient services for some hospitals, Ambulatory Payment Classification (APC) for these same hospitals for outpatient hospital services, cost based reimbursement for hospitals classified as Critical Access Hospitals and Resource Based Relative Value Scale (RBRVS) for physician/professional services. These reimbursement systems use cost, utilization, and other factors – such as measures of relative value or relative acuity – in determining provider payment rates.

Resource Based Relative Value System (RBRVS) Montana Medicaid reimburses physicians and other providers who bill on CMS-1500 forms with Medicare’s resource based relative value system (RBRVS). Reimbursement is based on the value of a service relative to all other services. The calculations compare the resources needed for a specific service (office expenses, malpractice insurance, and provider work effort and complexity) to those needed for other services. Each service code is assigned one or more relative value units (RVU’s) designating its position on the relative value scale. This system was developed nationally by Centers for Medicare & Medicaid Services (CMS), the American Medical Association, and non-physician provider associations; it is adjusted annually. Montana receives the benefit of this large, ongoing investment in research and policy-making without yielding control of costs. The fee for each code is determined by multiplying the RVU by a conversion factor with a dollar value. The conversion factor is Montana-specific to insure the overall budget neutrality of the Medicaid appropriation. The conversion factor is adjusted annually based on the Montana Legislature’s most recent biennial appropriation.

Price-Based Reimbursement System Nursing facilities are reimbursed under a case mix, price-based system where rates are determined annually, effective July 1. Each nursing facility receives a facility specific rate. The statewide price for nursing facility services is established annually through a public process. Each nursing facility’s payment is comprised of two components, the operating component including capital and the direct resident care component. Each nursing facility receives the same operating per diem rate, which is 80% of the statewide price. The remaining 20% of the statewide price represents the direct resident care component of the rate and is acuity adjusted using minimum data set (MDS). Each facility’s direct resident care component rate is specific to the facility based on the acuity of the Medicaid residents served in the facility.

The Montana Medicaid Program Report to the 2011 Legislature

Fee-for-Service Fee-for-service simply means that a fee is established for a certain product or service. Pharmacy services are one of the major services reimbursed under the fee for service methodology. Pharmacies receive both a dispensing fee for each prescription plus the cost of the ingredient.. Ingredient costs are reimbursed at the estimated acquisition cost for each product.

Medicaid uses the Medicare fee-for-service rates and per encounter payment systems for some programs. This allows efficient maintenance and the use of already established fee schedules for certain areas. Some examples of programs that use Medicare fee schedules include Durable Medical Equipment, Ambulatory Surgical Centers, and Federally Qualified Health Clinics.

COST CONTAINMENT MEASURES

The Medicaid program continues to develop cost containment measures that enhance the cost effectiveness and efficiency of the program. Some examples include:

School Based Services:  Services formerly paid with state or local funds only are now matched with federal funds in the Medicaid program. This has allowed children to receive additional needed services such as mental health care and speech therapy at no additional cost to the school district. The Office of Public Instruction certifies the match for the general fund portion for Medicaid reimbursed health-related services written into the Children’s Individualized Education Plans.

Health Resources Cost Containment Measures:  Nurse Advice Line - Toll free, confidential advice line available to all people with Medicaid. Registered nurses triage caller’s symptoms and guide callers to obtain care in appropriate settings (self-care, physician, or urgent or emergent care).

 Team Care - Medicaid clients with a history of using Medicaid services at an amount or frequency that is not medically necessary are required to participate in order to control utilization. Team Care clients are managed by a team consisting of a PASSPORT primary care provider, one pharmacy, the Nurse Advice Line, and DPHHS staff. Team Care currently has 600 clients.

 PASSPORT to Health - Primary Case Management Program was implemented in 1993 to cost-avoid medical costs and improve quality of care. A client chooses one primary care provider who performs or provides referrals for almost all of the client’s care. Periodic surveys show that more than 80% of both providers and clients are satisfied with PASSPORT to Health.

The Montana Medicaid Program Report to the 2011 Legislature

 Out-of-State Inpatient & Outpatient Hospital - Prior authorization requiring a mandatory advance approval for all inpatient hospital services out-of-state. Encourage the utilization of available health resources in-state.

 Prior authorization and assistance with obtaining certain transportation services.

 Bulk purchase of eyeglass services.

Pharmacy:  Prior Authorization - Mandatory advance approval of certain drugs before they are dispensed for any medically accepted indication.

 Drug Utilization Review - Prospective and retrospective review of drug use.

 Over-the-Counter Drug Coverage - When prescribed by a physician a cost effective alternative to higher priced federal legend drugs.

 Mandatory Generic Substitution - Requires pharmacies to dispense the generic form of the drug.

 Other Permissible Restrictions - Minimum or maximum quantities per prescription or number of refills.

 Preferred Drug List and Supplemental Rebates - Medicaid’s Drug Utilization Review Board/Formulary committee selects drugs in various classes of medications. Extensive review of the medications by the Board yields drugs that represent the best value to the Medicaid program. Many of the preferred drugs also provide supplemental rebates above what is currently offered to the Medicaid program.

 Drug Rebate Collection - The Department has two full time staff dedicated to the rebate program and the use of the Drug Rebate Analysis and Management System (DRAMS). The staff conducts claims audits and invoice audits prior to invoicing pharmaceutical manufacturers. These staff procedures assure more accurate invoices being sent to the manufacturers and eliminate or reduce disputes with the manufacturers. This results in more timely payments being received from the manufacturers. Drug rebates averaged approximately 30% of the Medicaid pharmacy expenditures. This percentage rate is higher than the past years and is related to Part D and the Average Manufacture Pricing (AMP) calculation. This percentage will be lower as the AMP rates are now being readjusted at the federal level for future fiscal years. The Department has also contracted with Affiliated Computer Services (ACS) to collect rebates on selected physician administered drugs.

The Montana Medicaid Program Report to the 2011 Legislature

Senior and Long Term Care Cost Containment Measures:

 Long term care insurance partnerships were added to the insurance options that are available in Montana for consumers. Purchase of insurance will help defray Medicaid costs in the future once partnership policies are utilized. An institutionalized/waiver individual or spouse who purchased a Qualified Long Term Care Partnership (LTC) policy or converted a previously-existing LTC policy to a Qualified LTC Partnership policy on or after July 1, 2009 may protect resources equal to the insurance benefits received from the policy.

Asset protection through LTC Partnership is available only after Qualified LTC Partnership policy lifetime limits have been fully exhausted on LTC services for the Medicaid applicant or spouse. The amount of assets protected will be equal to the insurance benefits paid

 Prior authorization for personal assistance services

 Intergovernmental fund transfer for counties to provide additional payments to at risk nursing facilities.

 Effective July 1, 2001 a new price based reimbursement methodology was adopted for reimbursement of nursing facilities in the state and continues to this day to provide for predictability in reimbursement for these providers.

 Nursing facility transitions have been used as a vehicle to provide services in the least restrictive setting to consumers who move from the nursing facility into community services; with dollars for services following them from the nursing facility budget in a money follows the person approach to rebalancing the long term care system. Typically individuals can be served in the community at a lower cost than in the institution. This approach has been in existence since 2004 and since that time over 250 individuals have transitioned to community options.

The Montana Medicaid Program Report to the 2011 Legislature

EXPENDITURE ANALYSIS

Medicaid services are funded by a combination of federal and state (and in some situations local) funds. The federal match rate for Medicaid services is based on a formula that takes into account the state average per capita income compared to the national average.

A decrease in the federal matching rate has a negative effect on the total dollars available for funding services. The following chart illustrates the effect of the loss of the FMAP that was made available by the federal government in times of national economic downturn.

Montana Medicaid Benefits Federal Matching

State Fiscal Year 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 Federal Match Rate 75.36% 71.96% 70.66% 69.29% 68.59% 74.80% 77.65% 74.58% 66.19% 65.74% State Funds Percent 24.64% 28.04% 29.34% 30.71% 31.41% 25.20% 22.35% 25.42% 33.81% 34.26%

Montana Medicaid Benefits Federal Matching FMAP State Share Blended Rates FY 2001‐2013 36.0% 35.0% Regular 34.0% Actual / Enhanced 33.0% 32.0% 31.0% 30.0% 29.0% 28.0% 27.0% 26.0% 25.0% 24.0% 23.0% 22.0% 21.0% 20.0% 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 ‐ State Fiscal Years ‐ FMAP Category 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 Blended FMAP 27.15% 27.12% 27.04% 27.19% 28.04% 29.34% 30.71% 31.41% 31.92% 32.52% 33.14% 33.81% 34.26% Actual ‐ Enhanced FMAP 27.15% 27.12% 25.85% 24.64% 28.04% 29.34% 30.71% 31.41% 25.20% 22.35% 25.42% 33.81% 34.26%

*Changes to Enhanced rate from FY 2003‐04 implemented as a result of the Jobs and Growth Tax Relief Reconciliation Act of 2003. *Changes to Enhanced rate from FY 2008‐11 due to the enactment of the American Recovery and Reinvestment Act of 2009.

The Montana Medicaid Program Report to the 2011 Legislature

Montana Medicaid Benefits Related Expenditures

The following series of Medicaid expenditure data only includes benefit related expenditures. It does not include administrative activity costs. Benefit related expenditures for Hospital Utilization Fee distributions, Medicaid Buy-in, Intergovernmental Transfers (IGT), Pharmacy Rebates, Part-D Pharmacy Clawback, Institutional Reimbursements for Medicaid, Third Party (TPL) and Medically Needy offsets are included. These are non-audited expenditures on a date of service basis.

Medicaid Benefit Related Expenditures by State Fiscal Year

$1,100,000,000

$1,000,000,000

$900,000,000

$800,000,000

$700,000,000

$600,000,000

$500,000,000

$400,000,000

$300,000,000

$200,000,000

$100,000,000 2004 2005 2006 2007 2008 2009 2010* 2011* 2012* 2013*

*2010 - 2013 Governor's Budgeted Amounts / Estimates Budgeted Federal and State Funds $1,000,000,000 $900,000,000 $800,000,000 $700,000,000 $600,000,000 $500,000,000 $400,000,000 $300,000,000 $200,000,000 $100,000,000 $0 SFY 2010 SFY 2011 SFY 2012 SFY 2013 Federal Funding $731,984,303 $739,084,025 $672,702,290 $697,972,886 State Special Revenue $65,218,289 $69,448,212 $64,746,166 $65,303,233 State General Fund $139,328,557 $169,964,072 $242,383,583 $250,582,368 Total Budgeted Expenditures $936,531,149 $978,496,309 $979,832,039 $1,013,858,487

The Montana Medicaid Program Report to the 2011 Legislature

Governor's Budget SFY 2010 to SFY 2013 Benefit Expenditures 150,000,000

125,000,000

100,000,000

75,000,000

50,000,000

25,000,000

SFY 2010 SFY 2011 SFY 2012 SFY 2013

Medicaid Expenditures (Projected / Gov's Budget) Categories SFY 2010 SFY 2011 SFY 2012 SFY 2013 Inpatient Hospital (including CAHS) $ 88,601,768 $ 91,041,203 $ 91,847,652 $ 93,416,736 Outpatient Hospital (including CAHS) $ 52,058,610 $ 53,410,428 $ 53,810,459 $ 54,806,608 Hospital Utilization Fees / DSH $ 76,384,586 $ 82,697,042 $ 67,024,129 $ 66,509,016 Other Hospital & Clinical Services $ 16,145,649 $ 16,336,068 $ 16,808,093 $ 17,372,430 Physician & Psych. $ 56,654,455 $ 58,902,896 $ 60,776,264 $ 62,143,518 Other Practitioners $ 7,113,728 $ 7,275,285 $ 7,355,331 $ 7,394,278 Other Managed Care Services $ 10,866,768 $ 12,065,707 $ 12,451,574 $ 12,685,770 Drugs & Part-D Clawback $ 78,457,507 $ 78,957,399 $ 78,864,717 $ 79,300,100 Drug Rebates $ (27,020,966) $ (20,506,609) $ (20,307,654) $ (19,509,500) Dental & Denturists $ 19,786,981 $ 22,656,093 $ 23,878,387 $ 24,594,739 Durable Medical Equipment $ 13,718,459 $ 13,799,329 $ 13,661,336 $ 13,661,336 Other Acute Services $ 9,898,808 $ 10,513,953 $ 10,762,452 $ 10,891,319 Nursing Homes & Swing Beds $ 152,492,178 $ 150,685,559 $ 140,715,098 $ 139,520,295 Nursing Home IGT $ 4,104,346 $ 3,671,830 $ 7,600,089 $ 8,614,173 Personal Care $ 34,658,984 $ 35,789,701 $ 36,886,796 $ 38,731,136 Other SLTC Home Based Services $ 11,432,562 $ 12,313,759 $ 10,655,403 $ 11,018,809 SLTC HCBS Waiver $ 36,022,758 $ 36,750,444 $ 32,771,294 $ 32,771,294 Medicare Buy-In $ 24,636,881 $ 26,550,000 $ 27,250,000 $ 27,970,000 Children's Mental Health $ 67,748,491 $ 70,058,173 $ 71,640,678 $ 72,649,460 Adult Mental Health and Chem Dep $ 42,760,975 $ 43,712,910 $ 44,048,665 $ 44,496,911 Disability Services Waiver $ 88,409,956 $ 91,814,001 $ 90,791,166 $ 92,158,422 Indian Health Services - 100% Fed funds $ 31,499,158 $ 34,334,082 $ 48,748,737 $ 60,935,921 School Based Services - 100% Fed funds $ 25,200,000 $ 31,248,000 $ 39,060,000 $ 48,825,000 MDC & ICF Facilities - 100% Fed funds $ 14,898,508 $ 14,419,054 $ 12,731,373 $ 12,900,719 Total $ 936,531,149 $ 978,496,309 $ 979,832,039 $ 1,013,858,487 *Updated 1/12/11. Some expenditure areas in 2011-2013 were realigned to match history. Total amount is unchanged, only reporting categories updated. 36

The Montana Medicaid Program Report to the 2011 Legislature

CHRONOLOGY OF MAJOR EVENTS IN MONTANA MEDICAID

2009 – The Disabilities Services Division was renamed the Developmental Services Division and includes Children’s Mental Health, the Developmental Disabilities Program, and Montana Developmental Center.

2009 – On January 1, the Developmental Disabilities Program received approval from CMS for the Children’s Autism Waiver. Within the year, 50 children were selected and services were implemented.

2009 - On October 1, 2008 a new program was implemented to serve elderly Montanan’s in a community setting. The Program for All inclusive Care for the Elderly (PACE) is a capitated managed care model that offers a comprehensive service delivery system and intergrated Medicare and Medicaid funding. This program is exclusively for individuals 55 and older who live in Yellowstone County or Livingston and meet nursing facility level of care.

2008- The 2007 Legislature provided Medicaid funding to provide a rate increase when health insurance is provided for direct care workers in the personal assistance and private duty nursing program. The 2009 Legislature annualized these funds in the Health Care for Health Care Worker program to cover the cost of premiums for health insurance that meets a defined benchmark criteria.

2008- In fiscal year 2008 the department began claiming 100% federal match for tribal entities providing Medicaid funded personal assistance services. Currently the Blackfeet, Rocky Boy and Fort Belknap Reservations provide personal assistance services that are reimbursed at 100% federal match.

2008 - The Medicaid Administrative Match (MAM) is a federal reimbursement program for the costs of “administrative activities” that directly support efforts to identify, and/or to enroll individuals in the Medicaid program or to assist those already enrolled in Medicaid to access benefits. Through MAM, contracted Montana Tribes are able to be reimbursed for allowable administrative costs directly related to the Montana State Medicaid plan or waiver service. The Montana Tribal MAM Cost Allocation Plan will give tribes a mechanism to seek reimbursement for the Medicaid administrative activities the Montana tribes now perform. Currently the Department is working on finalizing contracts with the Tribes.

2008 - The Hospital & Clinic program implemented the APR-DRG payment system and changed the ACS pricing methodology. On October 1, 2008, Montana Medicaid implemented a new inpatient reimbursement methodology for all hospitals, which is based on “All Patient Refined Diagnosis Related Groups” (APR-DRGs). In-state critical access hospitals will continue to be paid percent of charges using their cost-to-charge ratio. All other hospitals will be paid a prospective APR-DRG payment that reflects the cost of hospital resources used to treat similar cases.

The Montana Medicaid Program Report to the 2011 Legislature

2008 - On July 1, 2008 the Department submitted a Medicaid family planning waiver to the Centers for Medicare and Medicaid Services (CMS) for approval. Upon approval from CMS family planning services are anticipated to be provided to about 4,000 low-income women of child bearing age beginning in July 2009. The waiver will decrease the number of unintended pregnancies, improve the overall health of enrollees, and save money for the Montana Medicaid program.

2008 - In June of 2008 a pared down Health Insurance Flexibility and Accountability (HIFA) waiver was resubmitted to the Centers for Medicare and Medicaid Services for their consideration. The targeted uninsured (those without physical health care coverage) populations to be assisted with Medicaid benefits were refocused to include 1,600 individuals receiving limited mental health benefits through Mental Health Services Plan, 200 youth with a Serious Emotional Disturbance that had aged out of the Montana Foster Care system, and 150 individuals to be assisted with the costs of affordable health care coverage through their ability to participate in the Montana Comprehensive Health Association Premium Assistance Plan.

2008 - Increased the base wage rates for direct-care staff providing services to consumers with developmental disabilities and raised direct-care wages to at least $9.50 an hour.

2008 - The 2007 Legislature increased direct care worker wage to a minimum of $8.50 per hour, but in addition in SLTCD community based services was raised to $9.35 per hour and nursing homes to $9.20 per hour for certified nurse aides and personal care attendants. Also, direct care wage adjustments were legislatively approved for the providers who contract with the Children Mental Health Bureau.

2007 - Nursing facility provider tax was increased by $1.25 from $7.05 to $8.30 per day to fund nursing facility rates and services.

2007 - The eligibility requirements for pregnant women increased from 133% to 150% of the federal poverty level by legislative action.

2007 - The 2007 Legislature increased health-care provider rates, the increases vary across services and provider types, from a low of 1.39% to a high of 4.26%. The increases for SFY2007 generally began in October 2007 and the SFY2008 increases generally began in July 2008.

2007 - Home and Community-Based Services (HCBS) waiver for adults age 18 and over with severe disabling mental illness (SDMI), who without the waiver would be in nursing homes, was implemented. The SDMI waiver is available in certain core areas of the state and the surrounding counties. The waiver team in each core area consists of a nurse and a social worker who coordinates services provided to the covered individuals.

2007-Executed an agreement with the Chippewa Cree Tribe to facilitate the provision of Medicaid benefits to reservation residents. The agreement enables the Tribe to make Medicaid eligibility determinations on the reservation, reducing barriers or delays that might otherwise impede tribal members from obtaining Medicaid benefits and proper medical care.

The Montana Medicaid Program Report to the 2011 Legislature

2006 - Medicare Modernization Act implemented the Medicare Part D drug program that applied to approximately 16,000 Montanans who were eligible for both Medicare and Medicaid (dual eligibles). With the implementation of the Act, the dual eligibles will no longer receive prescription drug coverage through Medicaid, instead their prescription drugs are covered by a Medicare Part D plan. The Department is mandated to pay a portion of the drug cost through a Phased-Down Contribution (clawback) for dual eligible clients enrolled in Medicare Part D. Medicaid continues to cover barbiturates, benzodiazepines, smoking cessation drugs, prescription vitamins and the over-the-counter drugs for the dual eligibles as allowed in the Medicaid program.

2006 - The amount of assets a family can have and still qualify for children’s Medicaid increased from $3,000 to $15,000 as a result of 2005 Montana Legislative action. Families must continue to meet income requirements to be eligible for children’s Medicaid.

2006 - The most recent amendment to the Developmentally Disabled Waiver occurred. The waiver serves people with significant support needs and the amendment expanded service options to include adult foster support, community transition services, adult companionship, assisted living and residential training support.

2006 – The Health Insurance Flexibility and Accountability (HIFA) waiver was submitted to the Centers for Medicare and Medicaid Services (CMS). The Waiver is intended to create a mechanism for Medicaid to pay for services that have historically been funded entirely with state dollars. This will allow the freed up state dollars to leverage additional Medicaid federal dollars.

2006 – The Deficit Reduction Act of 2005 (DRA) mandated certain Medicaid eligibility changes for people who are going to be institutionalized, reside in a nursing home or who are on a waiting list for a Waiver opening. The DRA eligibility changes include increasing the penalty look-back period from three years to five years for nursing home benefits for individuals who transfer assets at less than fair market value, with the look-back period changed to begin when the individual becomes eligible for Medicaid; new citizenship and identity verification requirements of applications for Medicaid; annuities owned by an ineligible or community spouse are considered countable resources for Medicaid applicants; the unpaid balance of a promissory note is considered a countable resource for Medicaid applicants; and the establishment of a $500,000 home equity exclusion limit for long term care applicants/recipients.

2006 – Direct care worker wage increase of $1.00 per hour for nursing facilities and community service providers were implemented utilizing I-149 funding. Also, direct care wage adjustments were legislatively approved for the providers who contract with the Children Mental Health Bureau.

2006 – Implemented a 3% provider rate increase to nursing facilities and community service providers utilizing I-149 funding.

2006 – Nursing facility provider tax was increased by $1.75 from $5.30 to $7.05 to fund nursing facility provider rates and services.

The Montana Medicaid Program Report to the 2011 Legislature

2005 - As a result of the Montana Health Care Redesign Project the 2005 Montana Legislature authorized DPHHS to revise the asset test used to determine children’s eligibility for Medicaid and the submission of a Health Insurance Flexibility and Accountability (HIFA) Waiver.

2005 - Montana joined the National Medicaid Pooling Initiative (NMPI) in implementing a Preferred Drug List (PDL). The pooling initiative included seven other states: Nevada, Michigan, Vermont, New Hampshire, Alaska, Minnesota and Hawaii and will be implemented through a contract with First Health Services Corporation (FHSC). Under the initiative, the state Medicaid program will create a list of preferred medications in 50 classes of drugs. Preferred drugs are chosen based on their clinical efficiency by a committee of Montana physicians and pharmacists and by the Department based on cost savings. By contracting with FHSC, Montana was able to combine our 80,000 covered lives with covered lives of the other NMPI states resulting in over 3,000,000 covered lives which allow our contractor to negotiate lower discounts with Pharmaceutical Manufacturers.

2005 - The first five year renewal of the Developmental Disabilities Community Supports Waiver occurred. The waiver offers a number of innovative and flexible service options for persons with limited support needs.

2005 – Nursing facility provider tax was increased from $4.50 to $5.30 to fund nursing facility provider rates.

2004 - Team Care program was implemented to targeted to people who over-use the Medicaid system. The program requires a group of identified Medicaid clients to enroll in the program and choose one primary care provider and one pharmacy to manage their health care. Clients will receive the professional care they need and have a team to help them decide how and when to access care.

2004 - Montana Health Care Redesign Project Report was published. The Project resulted from 2003 Montana Legislative action and was intended to examine the various options for redesigning the Montana Medicaid program. The Report was provided to the 2005 Legislature outlining the options that could be undertaken to redesign the identified health programs in a fashion that was financially sustainable into the future.

2004 – Nurse First Care Management program was implemented to reduce ineffective use of medical services. Key components are a Nurse Advice Line for most individuals on Medicaid and a Disease Management program for those with chronic conditions such as asthma, diabetes and congestive heart failure.

2004 – FAIM Basic Medicaid waiver expired on January 31, 2004. A replacement 1115 waiver was approved effective February 1, 2004 continuing basic Medicaid coverage for able-bodied adults ages 21 - 64 who are not disabled or pregnant and who are eligible for Medicaid under - Sections 1925 or 1931 of the Social Security Act.

The Montana Medicaid Program Report to the 2011 Legislature

2004 - Hospital tax was implemented. This change provided increased reimbursement to hospitals using a state tax on hospitals matched with federal Medicaid dollars.

2004 – Nursing facility provider tax increased from $2.80 to $4.50 to fund nursing facility provider rates.

2003 – Children’s Mental Health Bureau was created in the Health Resources Division.

2003 – Eliminated coverage of gastric bypass surgery and routine circumcisions at the recommendation of the Medicaid Coverage Review Panel composed of Montana physicians.

2003 – Child and Family Services Division began billing Medicaid for targeted case management services provided to children at risk of abuse and neglect.

2003 – Outpatient reimbursement methodology was changed to Ambulatory Payment Classification (APC).

2003 – On January 10, 2003 implemented a 7% net pay reduction to providers (sunset June 30, 2003).

2003 – On February 1, 2003 reduced inpatient base rate for hospitals reimbursed by DRG prospective payment system (sunset June 30, 2003).

2003 – On August 1, 2003, reduced inpatient base rate for hospitals reimbursed by DRG prospective payment system. Changed all interim reimbursement rates for cost-based facilities to the hospital specific cost to charge ratio.

2002 – Increase cost sharing requirements for which the Medicaid eligible persons are responsible.

2002 – Began covering outpatient chemical dependency for adults.

2002 – Implemented a 2.6% net pay reduction to providers (sunset June 30, 2002).

2002 – Implemented reimbursement reductions to hospital inpatient services by reducing the base rates, decreasing the DRG weights by 2%, and eliminating the additional catastrophic case payment.

2002 – July 1, 2001 moved to a case mix price-based system of reimbursement for nursing facility providers.

2001 – Implemented a mandatory generic substitutive policy for pharmaceuticals in the outpatient drug program.

The Montana Medicaid Program Report to the 2011 Legislature

2001 - The Montana Legislature passed legislation creating the Montana Breast and Cervical Cancer Treatment program for low income uninsured women with breast or cervical cancer diagnosed through the National Breast and Cervical Cancer Early Detection Program, for their cancer treatment.

2001 – Implemented new reimbursement methodology for Ambulance & Dental Services. Included an 18% increase in funding for the dental program.

2000 – Medicaid HMO program was discontinued due to low penetration and high administrative expenses.

2000 – Nursing Facility Intergovernmental Transfers are implemented to save state general fund.

2000 – Hospital Intergovernmental Transfers are implemented.

2000 – Prior Authorization was required in Personal Assistance Services.

1999 – Mental Health Managed Care abandoned per legislative requirement.

1999 - Ambulatory Surgical Center provider reimbursement was restructured to align with Medicare reimbursement methodologies.

1998 – Area Agencies on Aging converted state general fund to buy slots to expand Waiver.

1997 - New MMIS contract was instituted with Consultec as the fiscal agent (Consultec later changed its name to Affiliated Computer Services – ACS).

1997 – Resource Based Relative Value System (RBRVS) was implemented to reimburse Physicians, Mid-Level Practitioners and Therapies.

1997 - Mental Health Managed Care was implemented. This program institutes a full-risk, capitated managed care contract for all mental health services statewide.

1997 – Prior authorization was required of Home Health Agency services.

1996 – Federal welfare reform was passed on August 22, 1996. Under the Personal Responsibility and Work Opportunities Reconciliation Act, Medicaid was “de-linked” from AFDC/TANF and began operating without regard to eligibility for cash assistance.

1996 - Departmental reorganization was implemented. Reorganization results in a decentralization of Medicaid; services are managed in divisions primarily responsible for services to specific populations. For example, the Addictive and Mental Disorders Division manages all Medicaid mental health services.

The Montana Medicaid Program Report to the 2011 Legislature

1996 - New outpatient prospective payment system was introduced. The system uses Day Procedure Groups (DPGs) to bundle services at one basic rate.

1995 - Liens and Estates Recovery Program was implemented by the legislature.

1995 - The Families Achieving Independence in Montana (FAIM), welfare reform waiver, received federal approval. The FAIM program began phasing-in implementation in February 1996. Even though the cash assistance caseload experienced a significant reduction, Medicaid eligibility continued for most of families. Cost savings were due to the reduced package of services under FAIM Basic Medicaid, not because of decreased caseloads.

1995 - The Medicaid HMO program was implemented for AFDC recipients in counties where HMOs exist.

1993 - Passport to Health program was implemented. The program assigns a primary care case manager provider to each participating Medicaid enrollee as a health care manager and gatekeeper of services. The program has yielded significant savings in subsequent years and maintained quality of care.

1993 - New hospital reimbursement system was implemented. The system features updated DRG rates and restrictions on procedures outside of the basic reimbursement package. This change results in significant savings in subsequent years.

1993 - Out of state hospital initiative was implemented. This program restricts the use of higher cost out of state hospitals when in state hospitals provide the same services. This initiative results in significant savings in subsequent years.

1993 - Medicaid coverage for inpatient psychiatric services was terminated by the legislature

1992 - Federal OBRA 89 increased eligibility for pregnant women and children under age 6 to 133% of the federal poverty level. OBRA 89 stipulates that children are eligible for all medically necessary services.

1992 - Federal OBRA 90 was implemented. A major component of this mandate is to increase eligibility for children aged 6 through 18 to 100% of the federal poverty level. This mandate is being phased in through 2002.

1992 - "Residential Psychiatric Services" was implemented as a Medicaid Service. This service brings rapid increases in cost for the next several years.

1992 - Drug Rebate Program was implemented and began to return a significant portion of prescription drug costs to the state in the form of rebates.

The Montana Medicaid Program Report to the 2011 Legislature

1992 - Formulary and Drug Utilization Review Program was implemented for Medicaid pharmacy services. This program provides significant internal controls and cost savings in subsequent years.

1991 - Nursing home provider tax was implemented. This change increased reimbursement to nursing homes using a state tax on nursing homes matched with federal Medicaid dollars.

1990 - Federal OBRA 87 was implemented. This federal mandate imposed new regulations for nurse aides, client safety, and client screening. This mandate affects primarily the nursing home industry and increased Medicaid costs through increased reimbursement to providers. OBRA87 also raised the threshold for financial eligibility to 100% of poverty for pregnant women and children younger than 6 years.

1988 - "Inpatient Psychiatric Services for Children under age 21" became a Medicaid service. This service increased costs rapidly for the next several years.

1987 - New Hospital reimbursement system was instituted. This Diagnosis Related Group (DRG) system is a prospective rate system.

1985 - New MMIS was instituted with Consultec as the fiscal agent.

1983 - Department lost Boren Amendment lawsuit to Montana Health Care Association (Nursing Homes) for insufficient reimbursement rates. Financial implications include: 1) retroactive payments for prior years; 2) increased reimbursement rates for subsequent years.

1982 - The HCBS waiver was implemented. This program consists of multiple services not traditionally offered to Medicaid recipients and designed to help people stay in their own homes rather than moving to an institution.

1982 - Prospective reimbursement system was instituted for the Nursing Home program.

The Montana Medicaid Program Report to the 2011 Legislature

GLOSSARY OF ACRONYMS

ACS: Affiliated Computer Services

AFDC: Aid to Families with Dependent Children

AMDD: Addictive and Mental Disorders Division

APC: Ambulatory Payment Classification

CD: Chemical Dependency

CFSD: Child and Family Services Division

CMS: Centers for Medicare and Medicaid Services

CPI: Consumer Price Index

DD: Developmental Disabilities

DPGs: Day Procedure Groups

DRAMS: Drug Rebate Analysis and Management System

DRG: Diagnosis Related Group

DSD: Developmental Services Division

EFE: Essential For Employment

EPSDT: Early and Periodic Screening, Diagnosis, and Treatment

FAIM: Families Achieving Independence in Montana

FFS: Fee-for-Service

FMAP: Federal Medical Assistance Percentage (the Federal reimbursement percentage for approved medical services)

FPL: Federal Poverty Level

FQHC: Federal Qualified Health Center

FY: Fiscal Year (state FY is July 1—June 30; federal FY is October 1—September 30) 45

The Montana Medicaid Program Report to the 2011 Legislature

HCFA: Health Care Financing Administration (now Centers for Medicare and Medicaid Services – CMS)

HCBS: Home and Community Based Services

HCPI: Health Care Price Index

HCSD: Human and Community Services Division

HMO: Health Maintenance Organization

HRD: Health Resources Division

ICF/MR: Intermediate Care Facility for Mental Retardation

IHS: Indian Health Services

IMD: Intermediate Care Facility for Mental Disease

MCDC: Montana Chemical Dependency Center

MDC: Montana Developmental Center

MH: Mental Health

MHO: Mental Health Organization

MMHNCC: Montana Mental Health Nursing Care Center

MMIS: Medicaid Management Information System

MSH: Montana State Hospital

NDC: National Drug Code

NH: Nursing Home

OBRA: Omnibus Budget Reconciliation Act

PAS: Personal Assistance Services

PD: Physically Disabled

QAD: Quality Assurance Division

The Montana Medicaid Program Report to the 2011 Legislature

RBRVS: Resource-Based Relative Value Scale

RHC: Rural Health Clinic

RVU: Relative Value Unit

SAMHSA: Substance Abuse and Mental Health Services Administration

SDMI: Severe and Disabling Mental Illness

SED: Serious Emotional Disturbance (children and adolescents)

SFY: State Fiscal Year (July 1—June 30)

SLTC: Senior and Long Term Care Division

SSI: Supplemental Security Income

TANF: Temporary Assistance for Needy Families

AMERICAN MEDICAL ASSOCIATION HOUSE OF DELEGATES

Resolution: 212 (I-12)

Introduced by: Louisiana Delegation

Subject: Pharmacist Administration of Vaccines

Referred to: Reference Committee B (Noel N. Deep, MD, Chair)

1 Whereas, In a concerted effort across this country to promote preventative care, which includes 2 improvement in the number of adequately immunized Americans, especially adults, many states 3 are allowing pharmacists to administer vaccines, often without any involvement or inclusion of 4 the patient's physician; and 5 6 Whereas, The CDC Advisory Committee on Immunization Practices recommends standing 7 orders, not physician orders, for pharmacist administration to be developed by the "state 8 pharmacy associations, board of pharmacy, and health departments" without mention of the 9 state's medical board thus minimizing physician input into this pharmacist expansion into the 10 practice of medicine1; and 11 12 Whereas, Our AMA has advocated strongly for a physician-led medical home model for patient 13 care, through which preventive medical services are coordinated and documented; and 14 15 Whereas, Although the increased access to immunizations by citizens of our country is 16 laudable, it should be weighed against the very real and substantial risk that the administration 17 of vaccines by pharmacists independently of the medical home reduces the opportunities for 18 physicians to provide other preventative services such as the prevention and detection of 19 treatable diseases such as hypertension, diabetes and heart disease which undermines our 20 national goals of integrated, accountable care; and 21 22 Whereas, Presently thirty-six states have legislated authority to pharmacists to administer 23 vaccines without a physician prescription or requiring collaboration with physicians, and there 24 exists an organized movement to expand this authority to all fifty states under the guise of 25 increased access to care; and 26 27 Whereas, Pharmacists may lack adequate training concerning the indications for and the 28 management of potential side effects of vaccine administration; and 29 30 Whereas, Access to one aspect of patient care should not come at the detriment of a patient's 31 overall preventive care; therefore be it 32 33 RESOLVED, That our American Medical Association recognize the role of the pharmacist as an 34 essential member of the medical home model health team and the potential role that 35 pharmacists may play in increasing immunization rates in this country (New HOD Policy); and 36 be it further

1 ASHP Guidelines on the Pharmacist's Role in Immunization, Am J Syst Pharm. 2000:60(13) 07/24/2003. Resolution: 212 (I-12) Page 2 of 4

1 RESOLVED, That our AMA reaffirm its commitment that such endeavors are physician-led and 2 that pharmacists administration of immunizations is only proper when any of the following 3 criteria are satisfied: 4 5 1) The pharmacist has an order from a physician licensed to practice medicine 6 in the state where the immunization is to be administered. 7 2) The pharmacist has a collaborative agreement with a physician licensed to 8 practice in the state where the immunization is to be administered. 9 3) The state where the immunization is to be administered has designated a 10 state of emergency which necessitates the rapid immunization of the 11 population in order to respond to the public health state of emergency. 12 Administration by pharmacists should be limited to the specific vaccine 13 required to respond to the emergency and only for the duration of the 14 emergency declaration (New HOD Policy); and be it further 15 16 RESOLVED, That our AMA support that a state's educational requirements of pharmacists who 17 administer immunizations be developed from input by both the state's boards of medicine and 18 pharmacy (New HOD Policy); and be it further 19 20 RESOLVED, That our AMA oppose any federal or state legislation allowing pharmacists to 21 administer immunizations without a licensed physician's order or collaborative agreement, or 22 during a designated state of emergency (New HOD Policy); and be it further 23 24 RESOLVED, That our AMA draft model legislation which supports a medical home model and 25 requires a physician’s written or standing order, or a collaborative practice agreement between 26 a physician and a pharmacist for the administration of immunizations, and to outline educational 27 and safety requirements which must be satisfied in order for a pharmacist to administer 28 immunizations (Directive to Take Action); and be it further 29 30 RESOLVED, That our AMA distribute this model legislation to state and specialty societies. 31 (Directive to Take Action)

Fiscal Note: Modest - between $1,000 - $5,000.

Received: 9/28/12 Resolution: 212 (I-12) Page 3 of 4

RELEVANT AMA POLICY

H-160.919 Principles of the Patient-Centered Medical Home 1. Our AMA adopts the American Academy of Family Physicians, American Academy of Pediatrics, American College of Physicians and the American Osteopathic Association "Joint Principles of the Patient-Centered Medical Home" as follows: Principles Personal Physician - Each patient has an ongoing relationship with a personal physician trained to provide first contact, continuous and comprehensive care. Physician Directed Medical Practice - The personal physician leads a team of individuals at the practice level who collectively take responsibility for the ongoing care of patients… (Res. 804, I-08; CMS Rep. 8, A-09; Reaffirmed: CME Rep. 15, A-10; Reaffirmed: Res. 723, A-11; Appended: Res. 723, A-11; Reaffirmed: BOT Rep. 9, I-11; Reaffirmed in lieu of Res. 706, A-12)

D-35.985 Support for Physician Led, Team Based Care Our AMA: 1. Reaffirms, will proactively advance at the federal and state level, and will encourage state and national medical specialty societies to promote policies H-35.970, H- 35.973, H-35.974, H-35.988, H-35.989, H-35.992, H-35.993, H-160.919, H-160.929, H-160.947, H-160.949, H-160.950, H-360.987, H 405.969 and D-35.988. 2. Will identify and review available data to analyze the effects on patients’ access to care in the opt-out states (states whose governor has opted out of the federal Medicare physician supervision requirements for anesthesia services) to determine whether there has been any increased access to care in those states. 3. Will identify and review available data to analyze the type and complexity of care provided by all non-physician providers, including CRNAs in the opt-out states (states whose governor has opted out of the federal Medicare physician supervision requirements for anesthesia services), compared to the type and complexity of care provided by physicians and/or the anesthesia care team. 4. Will advocate to policymakers, insurers and other groups, as appropriate, that they should consider the available data to best determine how non- physicians can serve as a complement to address the nation’s primary care workforce needs. 5. Will continue to recognize non-physician providers as valuable components of the physician- led health care team. 6. Will continue to advocate that physicians are best qualified by their education and training to lead the health care team. 7. Will call upon the Robert Wood Johnson Foundation to publicly announce that the report entitled, "Common Ground: An Agreement between Nurse and Physician Leaders on Interprofessional Collaboration for the Future of Patient Care" was premature; was not released officially; was not signed; and was not adopted by the participants. (BOT Rep. 9, I-11; Reaffirmed: CMS Rep. 1, A-12)

D-35.987 Evaluation of the Expanding Scope of Pharmacists' Practice Our AMA: (1) will re-evaluate the expanding scope of practice of pharmacists in America and develop additional policy to address the proposed new services provided by pharmacists that may constitute the practice of Medicine; (2) will continue to collect and disseminate state specific information in collaboration with state medical societies regarding the current scope of practice for pharmacists in each state; studying if and how each state is addressing these expansions of practice; (3) will develop model state legislation to address the expansion of pharmacist scope of practice that is found to be inappropriate or constitutes the practice of medicine, including but not limited to the issue of interpretations or usage of independent practice arrangements without appropriate physician supervision and work with interested states and specialties to advance such legislation; (4) opposes federal and state legislation allowing pharmacists to independently prescribe or dispense prescription medication without a valid order by, or under the supervision of, a licensed doctor of medicine, osteopathy, dentistry or podiatry; (5) opposes federal and state legislation allowing pharmacists to dispense medication beyond the expiration of the original prescription; and (6) opposes the inclusion of Doctors of Resolution: 212 (I-12) Page 4 of 4

Pharmacy (PharmD) among those health professionals designated as a "Physician" by the Centers for Medicare & Medicaid Services. (Res. 219, A-11; Appended: Res. 218, A-12)

H-35.973 Scopes of Practice of Physician Extenders Our AMA supports the formulation of clearer definitions of the scope of practice of physician extenders to include direct appropriate physician supervision and recommended guidelines for physician supervision to ensure quality patient care. (Res. 213, A-02; Reaffirmed: BOT Rep. 9, I-11)

D-35.996 Scope of Practice Model Legislation Our AMA Advocacy Resource Center will continue to work with state and specialty societies to draft model legislation that deals with non-physician independent practitioners’ scope of practice, reflecting the goal of ensuring that non-physician scope of practice is determined by training, experience, and demonstrated competence; and our AMA will distribute to state medical and specialty societies the model legislation as a framework to deal with questions regarding non-physician independent practitioners’ scope of practice. (Res. 923, I-03)

The MMA has been approached on what our position would be on a proposed legislative bill that would broaden the ability for pharmacists to give vaccinations to children and adults. Part of the benefits, in the view of the proponents, is the added convenience which may increase the number of individuals who do get vaccines and the expectation of lowering health care costs as patients would not incur an office visit charge to get a vaccination.

Dr. Beck did not recall that the MMA was opposed to the change that allowed pharmacists to give flu vaccines to younger individuals, but wanted me to reach out to all of you to gain your perspective on this bill and where MMA should stand.

I was also told of another potential bill yesterday where pharmacists are seeking reimbursement for “medicine care coordination.” My understanding is that a pharmacist would review medicines being taken by Medicaid patients with that patient, educate them about what they are taking and how the meds may or may not interact with other meds being taken, and get reimbursed by Medicaid for doing this.

Please share your thoughts on both of these legislative bill proposals. We will share your viewpoints at the Committee on Legislation meeting planned for next Tuesday.

Jean Branscum, Executive Vice President Montana Medical Association

Comments

1. Shaun J. Gillis M.D.

This came up at the AMA last month. In discussing with national leadership. ACOG was fine with adult vaccines that don't require a series (such as hep B, HPV)unless the pharmacists intend to document and follow-up to assure the series was received. Peds was opposed to any pharmacies providing vaccines to pediatric patients. My personal opinion is the same. Certain vaccines are fine but not for peds and not a vaccine series.

Jean, please pull the resolution that passed the AMA and see what the final outcome was. I know we can do what we feel is right as a state but having the national policy on hand may be helpful for deliberations.

2. Sheila Idzerda, M.D.

The Montana AAP executive committee just met last night None of us support vaccinations for children from pharmacists. It is an ongoing struggle to properly educate families about vaccines, effectiveness and side effects and this should be done in the medical home. In regard to medication "coordination of care", we thought this was part of a pharmacists job, not something extra

LAWS Bill Search Results Page Page 1 of 13

Introduced Bills Matching the Search Criteria

Current Logon ID - MMA

Preference List - MMA health care bills

* after status indicates the bill is probably dead Total number of Introduced Bills - 26 Total number of Introduced and Unintroduced Bills - 155

Bill Type LC Primary Status Status Short Title Note - Number Number Sponsor Date HB16 LC0241 Ellie Boldman (H) Referred to 12/05/2012 Revise involuntary Hill Committee -- (H) commitment and Judiciary emergency detention laws HB28 LC0311 Liz Bangerter (H) Referred to 12/05/2012 Allow review of maternal Committee -- (H) deaths Human Services HB60 LC0352 Tom Berry (H) Referred to 12/12/2012 Revising termination date Committee -- (H) for required review of Business and Labor certain boards HB61 LC0511 Ryan Lynch (H) Referred to 12/12/2012 Allow addiction Committee -- (H) counselors to treat Business and Labor gambling additions HB76 LC0290 Carolyn (H) Introduced 12/10/2012 Creating an independent Pease-Lopez office of child and family ombudsman HB83 LC0124 Pat Noonan (H) Introduced 12/11/2012 Require DPHHS to measure outcomes for children's mental health services HB84 LC0125 Pat Noonan (H) Introduced 12/11/2012 Revise 72-hour presumptive eligibility requirements for crisis stabilization HB87 LC0379 Jeffrey W (H) Introduced 12/11/2012 Provide state insurance Welborn commissioner with health insurance rate review authority HB94 LC0395 Ed Lieser (H) Introduced 12/12/2012 Include naturopath as health provider in unemployment insurance law HB98 LC0120 Pat Noonan (H) Introduced 12/12/2012 Appropriate funds to increase participation in the school breakfast program HB100 LC0123 Ron Ehli (H) Introduced 12/12/2012 Create a medicaid pay-for-

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performance pilot project HB101 LC0348 Ron Ehli (H) Introduced 12/12/2012 Increase reimbursement rates for children's medicaid mental health services HB102 LC0349 Ron Ehli (H) Introduced 12/12/2012 Create advisory committee on cost-base medicaid mental health rate reimbursement HB104 LC0657 Keith Regier (H) Introduced 12/12/2012 Criminalize offenses involving death to an unborn child HB109 LC0386 Edith (Edie) (H) Introduced 12/13/2012 Allow certain boards to McClafferty issue cease and desist orders for unlicensed practices HB113 LC0860 Jean Price (H) Introduced 12/13/2012 Provide medicaid coverage for orientation and mobility services HB119 LC0312 Carolyn (H) Introduced 12/14/2012 Allow payment of Pease-Lopez expenses for deceased Medicaid and MT healthy kid enrollees SB7 LC0150 Mary Caferro (S) Referred to 12/14/2012 Revise Medicaid Committee -- (S) application process Public Health, Welfare and Safety SB10 LC0331 Mary Caferro (S) Referred to 12/14/2012 Provide for licensure and Committee -- (S) regulation of mental Business, Labor, and health peer support Economic Affairs specialists SB29 LC0382 Edward (S) Introduced 12/04/2012 Revise primary sector Buttrey workforce program laws SB51 LC0302 Shannon (S) Introduced 12/11/2012 Eliminate report on Augare medical parolee health care costs SB55 LC0240 Christine (S) Introduced 12/12/2012 Clarify coverage of Kaufmann routine costs for patients in approved clinical trials SB64 LC0720 Tom Facey (S) Introduced 12/12/2012 Revise certain complaint provisions for professional and occupational licensing SB69 LC0151 Edward (S) Introduced 12/13/2012 Revise Medicaid Walker qualification enforcement laws SB79 LC0030 Dave Lewis (S) Introduced 12/14/2012 Revise laws regarding access to nonprofit

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hospital records SB84 LC0378 Christine (S) Introduced 12/14/2012 Establish standards and Kaufmann structure for patient- centered medical homes

Unintroduced Bills Matching the Search Criteria

* after status indicates the bill is probably dead Total number of Unintroduced Bills - 129

Bill Draft No. Request Status Requestor Status Short Title Note (LC No.) Date Date LC0015 04/28/2011 Edward Buttrey (C) Draft On Hold 11/24/2012 Enhance technology use in Montana LC0021 06/22/2011 Art Wittich (C) Draft On Hold 12/04/2012 Generally revise medicaid administration laws LC0038 02/01/2012 David E (C) Draft On Hold 11/14/2012 Generally revise Wanzenried medical marijuana laws LC0063 04/18/2012 Jason Priest (C) Draft Canceled* 11/13/2012 Require public employees to use the federal healthcare exchange to buy insurance LC0064 04/18/2012 Jason Priest (C) Draft Canceled* 11/13/2012 Require medicaid expansion population to buy insurance through federal exchange LC0079 04/19/2012 Bill Harris (C) Pre-Introduction 11/13/2012 Revise the Letter Sent Montana Federal Mandates Accountability Act LC0152 06/08/2012 David E (C) Draft On Hold 11/05/2012 Require public Wanzenried disclosure of health care facility acquired infections LC0231 07/06/2012 Art Wittich (C) Draft to 12/14/2012 Require federal Requester for Review receipts contingency plans

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LC0250 07/11/2012 David E (C) Draft On Hold 11/14/2012 Revise medical Wanzenried marijuana laws to authorize coverage for PTSD LC0257 07/11/2012 Edward Walker (C) Draft Request 07/11/2012 Revise laws Received related to dental insurance plans and services LC0330 09/04/2012 Anders Blewett (C) Draft in 11/29/2012 Establish youth Assembly/Executive concussion Director Review protection laws LC0385 09/14/2012 For Department (C) Pre-Introduction 12/11/2012 Generally revise of Labor and Letter Sent licensing board Industry by laws Economic Affairs Interim Committee LC0408 09/18/2012 Mary Caferro (C) Draft On Hold 11/24/2012 Generally revise Montana comprehensive health association laws LC0409 09/18/2012 Mary Caferro (C) Draft On Hold 12/01/2012 Generally revise Montana comprehensive health association laws LC0410 09/18/2012 Mary Caferro (C) Draft On Hold 10/29/2012 Generally revise insurance laws LC0411 09/18/2012 Mary Caferro (C) Draft On Hold 10/29/2012 Generally revise insurance laws LC0412 09/18/2012 Mary Caferro (C) Draft On Hold 10/29/2012 Generally revise insurance laws LC0413 09/18/2012 Mary Caferro (C) Draft On Hold 10/29/2012 Generally revise insurance laws LC0414 09/18/2012 Mary Caferro (C) Draft On Hold 10/29/2012 Generally revise insurance laws LC0415 09/18/2012 Mary Caferro (C) Draft On Hold 12/01/2012 Generally revise insurance laws LC0416 09/18/2012 Mary Caferro (C) Draft On Hold 12/01/2012 Generally revise insurance laws LC0417 09/18/2012 Mary Caferro (C) Draft On Hold 12/01/2012 Generally revise insurance laws LC0418 09/18/2012 Mary Caferro (C) Draft On Hold 12/01/2012 Generally revise insurance laws LC0419 09/18/2012 Mary Caferro (C) Draft Request 09/18/2012 Generally revise

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Received insurances laws LC0420 09/18/2012 Mary Caferro (C) Draft On Hold 10/29/2012 Generally revise insurance laws LC0421 09/18/2012 Mary Caferro (C) Draft On Hold 10/29/2012 Generally revise insurance laws LC0434 09/30/2012 Mary Caferro (C) Draft On Hold 12/11/2012 Require Medicaid and HMK to cover treatment of autism spectrum disorders LC0435 09/30/2012 Mary Caferro (C) Draft On Hold 12/01/2012 Generally revise insurance laws LC0442 09/30/2012 Kelly Flynn (C) Draft in 12/14/2012 Revise state Assembly/Executive employee health Director Review insurance program laws LC0465 10/09/2012 Mary Caferro (C) Draft On Hold 10/18/2012 Generally revise medical marijuana laws LC0507 10/16/2012 Gerald (Jerry) (C) Draft On Hold 11/23/2012 Generally revise Bennett workers' compensation laws LC0508 10/16/2012 Gerald (Jerry) (C) Draft Canceled* 11/16/2012 Generally revise Bennett joint and several liability laws LC0520 10/16/2012 For Department (C) Draft On Hold 11/19/2012 Revise nonprofit of Justice by and charitable Law and Justice solicitation laws Interim Committee LC0545 10/25/2012 Jim Keane (C) Draft Request 10/25/2012 Revise Received collaborative practice laws for pharmacy immunizations LC0546 10/25/2012 Jim Keane (C) Draft Request 10/25/2012 Establish the Received pharmancy audit integrity and recovery act LC0556 10/31/2012 Jason Priest (C) Draft Canceled* 11/13/2012 Revise laws relted to health insurance mandates LC0563 10/31/2012 Jason Priest (C) Draft in 12/14/2012 Require cost- Assembly/Executive benefit analysis of Director Review mandated health insurfance

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coverge of service LC0570 10/31/2012 David E (C) Draft Request 10/31/2012 Revise laws Wanzenried Received governing board of speech- language pathologists and audiologists LC0593 11/04/2012 Alan Olson (C) Draft Request 11/04/2012 Revise laws Received related to health insurance coverages, plans, and programs LC0598 11/05/2012 Clayton Fiscus (C) Draft to 12/14/2012 Require losing Requester for Review party in litigation to pay litigation costs in certain lawsuits LC0601 11/07/2012 Austin Knudsen (C) Draft On Hold 12/03/2012 Provided for multistate nurse licensure compact LC0603 11/07/2012 Austin Knudsen (C) Draft On Hold 11/20/2012 Revise medical lien laws LC0604 11/07/2012 Austin Knudsen (C) Draft On Hold 12/11/2012 Generally revise medical malpractice laws LC0605 11/07/2012 Austin Knudsen (C) Draft On Hold 12/13/2012 Generally revise medical malpractice laws LC0606 11/07/2012 Austin Knudsen (C) Draft to 12/13/2012 Generally revise Requester for Review medical malpractice laws LC0607 11/07/2012 Austin Knudsen (C) Draft On Hold 12/12/2012 Generally revise medical malpractice laws LC0608 11/07/2012 Austin Knudsen (C) Draft to 12/13/2012 Generally revise Requester for Review medical malpractice law LC0609 11/07/2012 Austin Knudsen (C) Draft Request 11/07/2012 Revise medical Received insurance and medical payment laws LC0610 11/07/2012 Austin Knudsen (C) Draft On Hold 12/13/2012 Revise laws related to health care provider service payments LC0612 11/08/2012 Austin Knudsen (C) Draft On Hold 12/13/2012 Revise laws dealing with peer review and health

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services LC0642 11/08/2012 Ellie Boldman (C) Pre-Introduction 11/28/2012 Eliminate license Hill Letter Sent exemption for certain private adolescent treatment programs LC0644 11/08/2012 Ellie Boldman (C) Draft On Hold 11/14/2012 Generally revise Hill medical marijuana laws LC0664 11/08/2012 Scott Reichner (C) Draft On Hold 11/23/2012 Generally revise medicaid laws LC0665 11/08/2012 Scott Reichner (C) Draft On Hold 11/23/2012 Generally revise medicaid laws LC0667 11/08/2012 Cary Smith (C) Pre-Introduction 12/07/2012 Revise laws Letter Sent related to medicaid and children's health program fraud LC0668 11/08/2012 Cary Smith (C) Draft to 12/07/2012 Authorize choice Requester for Review for out-of-state health care insurance LC0670 11/08/2012 Cary Smith (C) Pre-Introduction 11/28/2012 Provide for timely Letter Sent filing and resolution of claims in medical liability cases LC0673 11/08/2012 Cary Smith (C) Draft in 12/14/2012 Mandated benefits Assembly/Executive review by Director Review Insurance Commissioner for the Legislature LC0674 11/08/2012 Cary Smith (C) Pre-Introduction 11/26/2012 Authorize Letter Sent healthcare tax credits for individuals and out-of-pocket expenses LC0675 11/08/2012 Cary Smith (C) Draft Request 11/08/2012 Provide for high Received deductible health insurance via reimbursements and tax credits LC0676 11/08/2012 Cary Smith (C) Pre-Introduction 11/26/2012 Allow deductions Letter Sent of health care sharing ministry expenses

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LC0677 11/08/2012 Cary Smith (C) Draft Request 11/08/2012 Provide for health Received care sharing ministries and exempt from insurance laws LC0692 11/08/2012 Nicholas (C) Draft On Hold 12/01/2012 Generally revise Schwaderer state occupational licensing laws LC0728 11/14/2012 Kris Hansen (C) Draft in 12/14/2012 Generally revise Assembly/Executive laws related to Director Review solid waste licenses and fees LC0751 11/14/2012 Robyn Driscoll (C) Draft On Hold 12/05/2012 Revise pharmacy laws LC0754 11/14/2012 Jonathan Windy (C) Draft On Hold 11/14/2012 Generally revise Boy mental health laws LC0755 11/14/2012 Jonathan Windy (C) Draft On Hold 11/14/2012 Generally revising Boy mental health laws LC0756 11/14/2012 Jonathan Windy (C) Draft On Hold 11/16/2012 Generally revise Boy health care laws LC0757 11/14/2012 Jonathan Windy (C) Draft On Hold 11/16/2012 Generally revise Boy health care laws LC0771 11/15/2012 Pat Noonan (C) Draft On Hold 11/16/2012 Generally revise laws related to mental illness LC0772 11/16/2012 Pat Noonan (C) Draft On Hold 11/16/2012 Generally revise laws related to mental illness LC0776 11/16/2012 Pat Noonan (C) Draft On Hold 11/16/2012 Generally revise laws related to medical marijuana LC0777 11/16/2012 Pat Noonan (C) Draft On Hold 11/16/2012 Generally revise medical marijuana laws LC0778 11/16/2012 Pat Noonan (C) Draft On Hold 11/16/2012 Generally revise medicaid laws LC0779 11/16/2012 Pat Noonan (C) Draft On Hold 11/16/2012 Generally revise medicaid laws LC0821 11/17/2012 Kimberly Dudik (C) Draft Request 11/17/2012 Generally revise Received informed consent with medical decision laws LC0822 11/17/2012 Kimberly Dudik (C) Draft Request 11/17/2012 Revised medical Received provider reciprocity

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licensing laws LC0881 11/17/2012 Gerald (Jerry) (C) Draft Request 11/17/2012 Generally revise Bennett Received laws related to health and safety LC0882 11/17/2012 Gerald (Jerry) (C) Draft On Hold 11/19/2012 Generally revise Bennett laws related to health and safety LC0894 11/17/2012 John Brenden (C) Draft On Hold 12/05/2012 Revise tort laws LC0899 11/17/2012 Dick Barrett (C) Draft Request 11/17/2012 Establish Received guidelines and immunities for physicians who provide end of life care LC0900 11/17/2012 Jim Keane (C) Draft Request 11/17/2012 Expand medicaid Received coverage LC0903 11/17/2012 Mike Miller (C) Draft in 12/13/2012 Require DPHHS Assembly/Executive to provide Director Review Medicaid recipients with an explanation of benefits LC0907 11/17/2012 Taylor Brown (C) Draft to 12/10/2012 Renew Montana Requester for Review charitable endowment tax credit LC0920 11/19/2012 Kimberly Dudik (C) Draft Request 11/19/2012 Require hospitals Received to provide public reporting of patient outcomes LC0923 11/20/2012 Janna Taylor (C) Draft in 12/13/2012 Revise medical Assembly/Executive malpractice laws Director Review LC0967 11/25/2012 Kelly McCarthy (C) Draft to 12/01/2012 Allow medical Requester for Review marijuana care givers to receive compensation LC0968 11/25/2012 Kelly McCarthy (C) Draft in Legal 12/13/2012 Remove Review limitations on number of patients medical marijuana care givers can serve LC0969 11/25/2012 Kelly McCarthy (C) Draft in Legal 12/13/2012 Eliminate board Review of medical examiners' medical marijuana review

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requirements LC0970 11/25/2012 Kelly McCarthy (C) Draft in Legal 12/13/2012 Eliminate medical Review marijuana recordkeeping and unannounced inpsection provisions LC0974 11/26/2012 Chuck Hunter (C) Draft Request 11/26/2012 An act to create Received the Montana health care database LC0975 11/26/2012 Chuck Hunter (C) Draft Request 11/26/2012 Revising Received professional occupation and licensing board and commission laws LC1001 11/26/2012 Art Wittich (C) Draft Request 11/26/2012 Generally revise Received health care laws LC1002 11/26/2012 Art Wittich (C) Draft On Hold 11/26/2012 Generally revise health insurance laws LC1011 11/26/2012 Art Wittich (C) Draft On Hold 11/26/2012 Generally revise workers' compensation laws LC1018 11/26/2012 Art Wittich (C) Draft On Hold 11/26/2012 Generally revise laws related to government transparency LC1022 11/26/2012 Art Wittich (C) Draft On Hold 11/26/2012 Generally articulating states' rights LC1024 11/26/2012 Art Wittich (C) Draft On Hold 11/26/2012 Generally revise state agency and board organizational laws LC1030 11/26/2012 Art Wittich (C) Draft On Hold 11/26/2012 Generally revise state government organizational laws LC1047 11/26/2012 Krayton Kerns (C) Draft On Hold 11/27/2012 Generally nullify the Patient Protection and Affordable Care Act LC1065 11/28/2012 David E (C) Draft Request 11/28/2012 Generally revise

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Wanzenried Received emergency medical service laws LC1066 11/28/2012 David E (C) Draft Request 11/28/2012 Generally revise Wanzenried Received public health laws LC1085 11/29/2012 Tom Berry (C) Draft On Hold 12/04/2012 Generally revising laws related to the board of realty regulation LC1086 11/29/2012 Tom Berry (C) Draft On Hold 12/04/2012 Generally revise laws related to the board of public accountants LC1088 11/29/2012 Douglas Coffin (C) Draft On Hold 11/29/2012 Establish a newborn critical congenital heart disease screening program LC1094 11/30/2012 Liz Bangerter (C) Draft On Hold 12/12/2012 Generally revise optometry laws LC1099 11/30/2012 JP (C) Draft On Hold 12/01/2012 Generally revise Pomnichowski labor laws LC1100 11/30/2012 JP (C) Draft Request 11/30/2012 Generally revise Pomnichowski Received labor laws LC1109 11/30/2012 Roger Webb (C) Draft Request 11/30/2012 Revise laws Received related to hospitals and related facility 3rd party accreditation LC1122 11/30/2012 Jim Keane (C) Draft Request 11/30/2012 Generally revise Received medical practice laws LC1149 12/03/2012 Chuck Hunter (C) Draft Request 12/03/2012 Revise medicaid Received in home care services fraud prevention laws LC1150 12/03/2012 Chuck Hunter (C) Draft Request 12/03/2012 Establish Received directory of medicaid personal care services in Montana LC1152 12/03/2012 Steve Lavin (C) Draft to 12/06/2012 Revise laws Requester for Review related to training and use of defibrillators LC1192 12/04/2012 Scott Sales (C) Draft On Hold 12/05/2012 Generally revise welfare laws

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"Probably Dead" is a Bill Progress Category, and is assigned to those bills that have been voted down or missed a transmittal deadline, and to those bill drafts that have been canceled. To revive a bill that is "probably dead" typically requires a supermajority vote (usually a 2/3 vote) by the House or Senate.

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Introduced Bills Matching the Search Criteria

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Preference List - MMA Work Comp bills

* after status indicates the bill is probably dead Total number of Introduced Bills - 1 Total number of Introduced and Unintroduced Bills - 10

Bill Type - LC Primary Status Status Short Title Note Number Number Sponsor Date SB54 LC0353 Tom Facey (S) 12/12/2012 Require worker's compsenation Introduced coverage for volunteer firefighters

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Bill Draft No. Request Status Requestor Status Short Title Note (LC No.) Date Date LC0116 05/08/2012 Edward (C) Draft On 10/25/2012 Generally revise workers' Walker Hold compensation laws LC0397 09/14/2012 Llew Jones (C) Draft 09/14/2012 Revise worker's compensation Request laws Received LC0577 11/02/2012 Edward (C) Draft 11/02/2012 Strengthen exclusive remedy Walker Request laws in workers' Received compensation LC0580 11/02/2012 Austin (C) Draft 11/02/2012 Generally revise workers' Knudsen Request compensation laws Received LC0635 11/08/2012 Dee Brown (C) Draft On 12/13/2012 Establish a workers' Hold compensation holiday for employers for new hires LC0872 11/17/2012 Anders (C) Draft 11/17/2012 Revise old fund workers' Blewett Request compensation fund liability Received LC1179 12/04/2012 Fred (C) Draft 12/04/2012 Generally revise workers' Thomas Request compensation laws Received LC1183 12/04/2012 Fred (C) Draft On 12/05/2012 Generally revise workers' Thomas Hold compensation laws LC1335 12/04/2012 Alan Olson (C) Draft 12/04/2012 Revise laws related to Request workers' compensation

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Received

http://laws.leg.mt.gov/legprd_pref/law_utilities.CallBillSearchResults?P_ENTY_ID_SE... 12/14/2012 Becky Zaharko

From: Jean Branscum Sent: Tuesday, December 18, 2012 4:43 PM To: Tonya McCormack; Becky Zaharko Subject: FW: Stark Law and ancillary services

Jean Branscum, Executive Vice President Montana Medical Association 2021 Eleventh Avenue Helena, Montana 59601 406/443-4000 ext. 105 Toll free (intrastate): 877/443-4000 406/439-5960 (cell); 406/443-4042(fax) [email protected] From: Jean Branscum Sent: Wednesday, December 12, 2012 2:38 PM To: Sami Spencer Cc: Shaun J. Gillis, M.D.; Carter E. Beck, M.D.; Carter E. Beck, M.D./Kathleen Ryan Subject: Stark Law and ancillary services

Sami, I met with staff in Senator Baucus’ office on Monday and discussed the in‐office ancillary services exception to the Stark Law. The Senate Finance and Claims staffer, Matt Kazan, attended and was pretty firm that this could be a real possibility because:

1) While the intent was for ease of scheduling and getting services same day, it is believed that these “exceptions” are not being done same day for purposes of a quicker medical diagnosis. 2) A GAO study shows that the services delivered by physicians who self‐refer are higher in number when compared to what is ordered by a physician who is not self‐referring. 3) Need to find monies for the “grand bargain” that will be struck in 2013.

The MMA was challenged to review the GAO report (below) and explain to Matt why self‐referring physicians would order more of these services, to share any reasoning for belief that some of the exceptions do meet intent and should remain as an exception, and to offer up where monies might be found for the grand bargain.

I wanted to share this with you in hopes that the physicians there could provide additional input and comments on Matt’s challenge related to the ancillary services. This item was discussed at the Committee on Legislation which led to the discussion I had with Senator Baucus’ staff earlier this week. This Committee will meet again in the upcoming week and any input from physicians there would be helpful. http://gao.gov/products/GAO‐12‐966

Thank you!

Jean Branscum, Executive Vice President Montana Medical Association 2021 Eleventh Avenue Helena, Montana 59601 406/443-4000 ext. 105 1 Toll free (intrastate): 877/443-4000 406/439-5960 (cell); 406/443-4042(fax) [email protected]

2 United States Government Accountability Office GAO Report to Congressional Requesters

September 2012 MEDICARE Higher Use of Advanced Imaging Services by Providers Who Self-Refer Costing Medicare Millions

To access this report electronically, scan this QR Code. Don't have a QR code reader? Several are available for free online.

GAO-12-966 September 2012 MEDICARE Higher Use of Advanced Imaging Services by Providers Who Self-Refer Costing Medicare Millions

Highlights of GAO-12-966, a report to congressional requesters

Why GAO Did This Study What GAO Found Medicare Part B expenditures—which From 2004 through 2010, the number of self-referred and non-self-referred include payment for advanced imaging advanced imaging services—magnetic resonance imaging (MRI) and computed services—are expected to continue tomography (CT) services—both increased, with the larger increase among self- growing at an unsustainable rate. referred services. For example, the number of self-referred MRI services Questions have been raised about self- increased over this period by more than 80 percent, compared with an increase referral’s role in this growth. Self- of 12 percent for non-self-referred MRI services. Likewise, the growth rate of referral occurs when a provider refers expenditures for self-referred MRI and CT services was also higher than for non- patients to entities in which the self-referred MRI and CT services. provider or the provider’s family members have a financial interest. GAO’s analysis showed that providers’ referrals of MRI and CT services GAO was asked to examine the substantially increased the year after they began to self-refer—that is, they prevalence of advanced imaging self- purchased or leased imaging equipment, or joined a group practice that already referral and its effect on Medicare self-referred. Providers that began self-referring in 2009—referred to as spending. This report examines switchers—increased MRI and CT referrals on average by about 67 percent in (1) trends in the number of and 2010 compared to 2008. In the case of MRIs, the average number of referrals expenditures for self-referred and non- switchers made increased from 25.1 in 2008 to 42.0 in 2010. In contrast, the self-referred advanced imaging average number of referrals made by providers who remained self-referrers or services, (2) how provision of these non-self-referrers declined during this period. This comparison suggests that the services differs among providers on increase in the average number of referrals for switchers was not due to a the basis of whether they self-refer, general increase in the use of imaging services among all providers. GAO’s and (3) implications of self-referral for Medicare spending. GAO analyzed examination of all providers that referred an MRI or CT service in 2010 showed Medicare Part B claims data from 2004 that self-referring providers referred about two times as many of these services through 2010 and interviewed officials as providers who did not self-refer. Differences persisted after accounting for from the Centers for Medicare & practice size, specialty, geography, or patient characteristics. These two Medicaid Services (CMS) and other analyses suggest that financial incentives for self-referring providers were likely a stakeholders. Because Medicare major factor driving the increase in referrals. claims lack an indicator identifying self- referred services, GAO developed a Change in Average Number of MRI Services Referred, 2008 and 2010 claims-based methodology to identify self-referred services and expenditures Average 2008 referred Average 2010 referred and to characterize providers as self- MRI services MRI services Percentage change referring or not. Switchers 25.1 42.0 67.3 What GAO Recommends Non-self-referrers 20.6 19.2 -6.8 Self-referrers 47.0 45.4 -3.4

GAO recommends that CMS improve Source: GAO analysis of Medicare data. its ability to identify self-referral of Note: Pattern observed for MRI services was similar for CT services. GAO defines switchers as those advanced imaging services and providers that did not self-refer in 2007 or 2008, but did self-refer in 2009 and 2010. address increases in these services. The Department of Health and Human GAO estimates that in 2010, providers who self-referred likely made 400,000 Services, which oversees CMS, stated more referrals for advanced imaging services than they would have if they were it would consider one recommendation, not self-referring. These additional referrals cost Medicare about $109 million. To but did not concur with the others. the extent that these additional referrals were unnecessary, they pose GAO maintains CMS should monitor these self-referred services and ensure unacceptable risks for beneficiaries, particularly in the case of CT services, which they are appropriate. involve the use of ionizing radiation that has been linked to an increased risk of developing cancer. View GAO-12-966. For more information, contact James C. Cosgrove at (202) 512-7114 or [email protected].

United States Government Accountability Office

Contents

Letter 1 Background 7 Self-Referred MRI and CT Services and Expenditures Grew Overall, While Non-Self-Referred Services and Expenditures Grew Slower or Decreased 10 Self-Referring Providers Referred Substantially More Advanced Imaging Services on Average Than Did Other Providers 16 Higher Use of Advanced Imaging Services by Self-Referring Providers Results in Substantial Costs to Medicare 22 Conclusions 24 Recommendations for Executive Action 25 Agency Comments and Our Evaluation 25

Appendix I Scope and Methods 30

Appendix II Select Implemented or Proposed Policies Designed to Address Self-Referral or the Utilization of Advanced Imaging Services 37

Appendix III Self-Referral of MRI and CT Services, by Provider Specialty, in 2004 and 2010 40

Appendix IV Comments from the Department of Health and Human Services 42

Appendix V GAO Contact and Staff Acknowledgments 46

Tables Table 1: Average Number of MRI and CT Services Referred by Non- Self-Referring and Self-Referring Providers, 2010 18 Table 2: Average Number of MRI and CT Services Referred by Non- Self-Referring and Self-Referring Providers in Urban and Rural Locations, 2010 20

Page i GAO-12-966 Medicare Self-Referral of Advanced Imaging Services

Table 3: Patient Characteristics of Non-Self-Referring and Self- Referring MRI and CT Providers, 2010 21 Table 4: Change in Average Number of MRI and CT Services Referred, 2008 and 2010 22 Table 5: Self-referral Rates of MRI and CT Services for Select Provider Specialties 41

Figures Figure 1: Distribution of Advanced Imaging Services by Modality and Setting, 2010 9 Figure 2: Number of Self-Referred and Non-Self-Referred MRI Services, 2004-2010 11 Figure 3: Number of Self-Referred and Non-Self-Referred CT Services, 2004-2010 12 Figure 4: Self-Referred and Non-Self-Referred MRI Expenditures, 2004-2010 14 Figure 5: Self-Referred and Non-Self-Referred CT Expenditures, 2004-2010 15 Figure 6: Potential Savings under Alternative Scenario for Self- Referring Providers, 2010 23

Page ii GAO-12-966 Medicare Self-Referral of Advanced Imaging Services

Abbreviations

BETOS Berenson-Eggers Type of Service CMS Centers for Medicare & Medicaid Services CT computed tomography DRA Deficit Reduction Act of 2005 FFS fee-for-service HCPCS Healthcare Common Procedure Coding System HHS Department of Health and Human Services IDTF independent diagnostic testing facility MedPAC Medicare Payment Advisory Commission MRI magnetic resonance imaging NPI national provider identifier PC professional component PPACA Patient Protection and Affordable Care Act TC technical component TIN taxpayer identification number

This is a work of the U.S. government and is not subject to copyright protection in the United States. The published product may be reproduced and distributed in its entirety without further permission from GAO. However, because this work may contain copyrighted images or other material, permission from the copyright holder may be necessary if you wish to reproduce this material separately.

Page iii GAO-12-966 Medicare Self-Referral of Advanced Imaging Services United States Government Accountability Office Washington, DC 20548

September 28, 2012

Congressional Requesters

Expenditures for Medicare Part B services—which include physician and other outpatient services—are expected to continue exceeding the overall growth rate of the U.S. economy, heightening concerns about the long- range fiscal sustainability of Medicare.1 While Medicare spending growth has slowed in recent years, expenditures for Medicare Part B grew by an average of 5.9 percent annually from 2007 through 2011 and are projected to grow by an average of 7.6 percent annually from 2012 through 2016.2 In comparison, the national economy grew by an average annual rate of 2.5 percent from 2007 through 20113 and is projected to increase on average by 4.6 percent annually from 2012 through 2016.4 Medicare Part B spending includes payments for advanced imaging services—magnetic resonance imaging (MRI) and computed tomography (CT) services—which providers use in the diagnosis and treatment of many diseases and disorders, such as different types of cancer, cardiovascular diseases, and musculoskeletal disorders.5

1Medicare is the federally financed health insurance program for persons aged 65 and over, certain individuals with disabilities, and individuals with end-stage renal disease. Medicare Part A covers hospital and other inpatient stays. Medicare Part B is optional insurance, and covers physician, outpatient hospital, home health care, and certain other services. Medicare Parts A and B are known as original Medicare or Medicare fee-for- service (FFS). 2See The Boards of Trustees, 2012 Annual Report of the Boards of Trustees of the Federal Hospital Insurance and Federal Supplementary Medical Insurance Trust Funds (Washington, D.C.: April 2012). The projected Medicare Part B growth rate assumes that scheduled statutory cuts in physician payment rates will be overridden by Congress as they have been every year since 2003. 3See Bureau of Economic Analysis, “Gross Domestic Product (GDP) Percent change from preceding period,” National Economic Accounts (Washington, D.C.: May 31, 2012), accessed June 27, 2012, http://www.bea.gov/national/xls/gdpchg.xls. 4See Congressional Budget Office, The Budget and Economic Outlook: Fiscal Years 2012 through 2022 (Washington, D.C.: January 2012). 5Other advanced imaging services include nuclear medicine services. For the purposes of this report, “advanced imaging services” refers to only MRI and CT services.

Page 1 GAO-12-966 Medicare Self-Referral of Advanced Imaging Services

Policymakers and researchers have raised questions about the growth in Part B spending, noting that some of this growth may be partially attributed to self-referral and that not all of the advanced imaging services provided may be appropriate or necessary.6 Self-referral occurs when providers refer their patients to entities—such as themselves or a group practice—with which they or an immediate family member has a financial relationship, such as when a provider refers patients to his or her office for advanced imaging services after the provider purchases or leases advanced imaging equipment.7 Proponents of self-referral point out that such arrangements allow providers to make rapid diagnoses, improve coordination of care, and provide convenient access for patients. However, critics of self-referral note that the incentive for financial gain in such arrangements may result in inappropriate, unnecessary, or potentially harmful services. For example, CT services expose beneficiaries to ionizing radiation, which is associated with an increased risk of cancer.

Growth in imaging services expenditures—including expenditures for advanced imaging services—have prompted action from Congress and resulted in recommendations from us and others. Specifically, Congress, as part of the Deficit Reduction Act of 2005 (DRA),8 required that

6For example, see Laurence C. Baker, “Acquisition of MRI Equipment by Doctors Drives Up Imaging Use and Spending,” Health Affairs, vol. 29, no. 12 (2010); Medicare Payment Advisory Commission, Report to the Congress, Improving Incentives in the Medicare Program (Washington, D.C.: June 2009); and Senator Grassley Press Release, Grassley Works to Protect Medicare Dollars, Empower Patients with Information (July 25, 2008), accessed May 31, 2012. http://www.finance.senate.gov/newsroom/ranking/release/?id=bb006ccf-dedc-40fd-9b14- 6074cb2687f3. 7Compliance with the physician self-referral law, commonly known as the Stark law, is outside the scope of this report. The Stark law prohibits physicians from making referrals for certain designated health services paid for by Medicare, to entities with which the physicians or immediate family members have a financial relationship, unless the arrangement complies with a specified exception, such as in-office ancillary services. 42 U.S.C. § 1395nn(b)(2).The requirements of the in-office ancillary services exception are found at 42 C. F. R. § 411.355(b) (2011).The Patient Protection and Affordable Care Act (PPACA) amended the Stark law to establish an additional requirement with respect to the in-office ancillary services exception for certain types of advanced imaging services. That is, self-referring physicians must inform patients in writing at the time of referral for these services that the patient may obtain the service from a person other than the referring physician or someone in the physician’s group practice and provide the patient with a list of suppliers who furnish the service in the area in which the patient resides. Pub. L. No. 111-148, § 6003, 124 Stat. 119, 697 (codified at 42 U.S.C. § 1395nn(b)(2)). 8Pub. L. No. 109-171, § 5102(b), 120 Stat. 4, 39-40 (2006).

Page 2 GAO-12-966 Medicare Self-Referral of Advanced Imaging Services

Medicare payment for certain imaging services under the Medicare physician fee schedule—the payment system used to determine fees for physician-billed services in Medicare FFS—not exceed the amount Medicare pays under the hospital outpatient prospective payment system, used to pay for hospital outpatient services. In our 2008 report, we recommended that, to address the rapid growth in Medicare Part B imaging expenditures, the Centers for Medicare & Medicaid Services (CMS)—the agency within the Department of Health and Human Services that administers the Medicare program—examine the feasibility of expanding the use of front-end approaches for managing the utilization of advanced imaging services.9 Front-end approaches to managing services are conducted prior to, rather than after, services are performed and payment is made. Examples of such approaches include requiring prior authorization (specific approval from a payer to perform a service) and privileging (limiting the authority to order certain services to only providers with specified qualifications). In contrast, back-end approaches are used after CMS issues payment, and could include targeted audits of providers that refer a high volume of services. Further, the Medicare Payment Advisory Commission (MedPAC) has recommended that certain providers with higher advanced imaging utilization participate in a prior authorization program and that CMS reduce payment rates for imaging services when the same provider orders and performs a service.10 According to MedPAC, such a reduction would account for certain efficiencies that occur when the same provider orders and performs a service. Specifically, in these situations, the provider has likely already performed certain work involved in interpreting an imaging service, such as reviewing the patient’s history, prior to making the referral. As of June 2012, CMS has not implemented MedPAC’s or our recommendation.

You asked us to examine the prevalence of self-referral for advanced imaging services and Medicare spending for these services.11 In this

9See GAO, Medicare Part B Imaging Services: Rapid Spending Growth and Shift to Physician Offices Indicate Need for CMS to Consider Additional Management Practices, GAO-08-452 (Washington, D.C.: June 13, 2008). 10See Medicare Payment Advisory Commission, Report to the Congress: Medicare and the Healthcare Delivery System (Washington, D.C.: June 2011).

11In addition to this report on advanced imaging, we also have ongoing work related to the self-referral of anatomic pathology services, intensity-modulated radiation therapy services, and physical therapy services.

Page 3 GAO-12-966 Medicare Self-Referral of Advanced Imaging Services

report, we examine (1) trends in the number of and expenditures for self- referred and non-self-referred advanced imaging services from 2004 through 2010, (2) the extent to which the provision of advanced imaging services differs for providers who self-refer when compared with other providers, and (3) the implications of self-referral for Medicare spending on advanced imaging services.

To identify trends in the number of and expenditures for self-referred and non-self-referred advanced imaging services from 2004 through 2010, we analyzed claims from the Medicare Part B Carrier File for MRI and CT services.12 Because there is no indicator or “flag” on the claim that identifies whether services are self-referred or non-self-referred and CMS has no other method for identifying whether a service was self-referred, we developed a claims-based methodology for identifying self-referred services.13 Specifically, we classified services from the period we reviewed as self-referred if the provider that referred the beneficiary for a MRI or CT service and the provider that performed the MRI or CT service were identical or had a financial relationship with the same entity.14 We removed MRI or CT services referred by radiologists or other providers that primarily practice in an independent diagnostic testing facility (IDTF) because they have limited ability to self-refer services.15 We limited the universe for this portion of our analysis to those advanced imaging

12For the purposes of our report, we limited MRI or CT services (1) to those that were designated health services—services which, in the absence of an exception, a physician may not make a referral to furnish to an entity with which he has a financial relationship without implicating the Stark law—and (2) to those where the service includes the performance of the imaging service—which can be billed with or separately from the interpretation of a MRI or CT imaging service. 13An indicator or “flag” could be, for example, a modifier that a provider lists on a claim to indicate that a service is self-referred. Providers currently use modifiers to provide additional information about a service to CMS. For example, if a provider is only billing for the technical component of an imaging service, the provider would use a modifier to alert CMS that the claim does not cover the professional component of the service. 14Providers could have a financial relationship with the same entity if, for example, they are part of the same group practice. 15IDTFs are diagnostic testing facilities that are independent of a physician’s office or hospital and that comply with a number of requirements including those related to the use of qualified supervising physicians, qualified nonphysician personnel, performance of only specifically ordered tests, and compliance with all applicable state laws. See 42 C.F.R. § 410.33 (2011). Radiologists and providers in IDTFs predominantly perform advanced imaging services and have limited ability to refer beneficiaries for advanced imaging services. These providers are unlikely to self-refer MRI or CT services.

Page 4 GAO-12-966 Medicare Self-Referral of Advanced Imaging Services

services performed in a provider’s office or in an IDTF, which represents approximately one-fifth of all advanced imaging services provided to Medicare FFS beneficiaries.16 Providers in our analysis include primarily physicians, but could include other providers, such as nurse practitioners and physician assistants. We focused on services performed in these settings because our previous work showed rapid growth among such services and because the financial incentive for providers to self-refer is most direct when the service is performed in a physician office. We used the claims to identify trends in the number and proportion of self-referred and non-self-referred MRI and CT services performed from 2004 through 2010, the expenditures for these services from 2004 through 2010, and the proportion of self-referred and non-self-referred MRI and CT services by provider specialty for 2004 and 2010. To determine expenditures, we used the allowed charges variable from the Medicare Part B Carrier File, which includes the amounts paid by Medicare and the beneficiary.

To determine the extent to which the provision of advanced imaging services differed for providers who self-refer when compared with other providers, we performed two separate analyses. First, we compared the provision—that is, the number of referrals made—of MRI and CT services by self-referring providers and non-self-referring providers in 2010, after accounting for factors such as practice size (i.e., the number of Medicare beneficiaries), provider specialty, geography (i.e., urban or rural), and patient characteristics.17 For this analysis, our universe of providers included all those providers that referred at least one MRI or CT service, except for providers that had a specialty of radiology, emergency medicine, or provided services in an IDTF.18 Second, we determined the extent to which the number of MRI and CT referrals made by providers changed after they began to self-refer. Specifically, we identified a group

16Providers can also provide advanced imaging services in settings other than physician offices or IDTFs, such as hospitals. 17We defined urban areas as metropolitan statistical areas, a geographic entity defined by the Office of Management and Budget as a core urban area of 50,000 or more population; all other settings are considered rural. 18Providers with a radiology or IDTF specialty were removed because they have limited ability to refer beneficiaries for advanced imaging services, and thus are not likely to self- refer MRI or CT services. We excluded emergency medicine providers from our analysis because they did not practice in provider offices. After we made our exclusions, there were 419,884 providers that referred at least one MRI service and 477,547 providers that referred at least one CT service in 2010.

Page 5 GAO-12-966 Medicare Self-Referral of Advanced Imaging Services

of providers that began to self-refer advanced imaging services in 2009. We then calculated the change in the number of MRI or CT referrals made from 2008 (i.e., the year before they began self-referring) to 2010 (i.e., the year after they began self-referring). We compared the change in the number of referrals made by these providers to the change in the number of referrals made over the same time period by providers who did not change whether or not they self-referred advanced imaging services. We classified providers as self-referring if they self-referred at least one MRI or CT service and non-self-referring if they referred—but did not self- refer—at least one MRI or CT service.19 For both analyses we counted all services that a provider referred, regardless of whether it was performed in a provider office, IDTF, or other setting, such as a hospital.

To determine the implications of self-referral for Medicare spending on advanced imaging services, we estimated what Medicare expenditures under the physician fee schedule for self-referred advanced imaging services would have been in 2010 if the rate of referrals made by self- referring providers equaled the rate of referrals made by providers who did not self-refer. We compared this to the actual expenditures under the physician fee schedule, using the allowed charges variable, for self- referred advanced imaging services of the same specialty and provider size and calculated the difference. To ensure comparisons were meaningful, we limited this analysis to providers in those specialties that had at least 1,000 self-referring providers.20

We took several steps to ensure that the data used to produce this report were sufficiently reliable. Specifically, we assessed the reliability of the CMS data we used by interviewing officials responsible for overseeing these data sources, reviewing relevant documentation, and examining the data for obvious errors. We determined that the data were sufficiently reliable for the purposes of our study. (See app. I for more details on our scope and methodology.)

19In 2010, 35,950 providers self-referred an MRI service and 39,913 providers self- referred a CT service. In comparison, there were 383,934 non-self-referring MRI providers and 437,634 non-self-referring CT providers. 20We defined physician specialty using the specialty codes included in the Medicare claims. These specialty codes include physician specialties, such as cardiology and hematology/oncology, and nonphysician provider types, such as nurse practitioners and physician assistants.

Page 6 GAO-12-966 Medicare Self-Referral of Advanced Imaging Services

We conducted this performance audit from May 2010 through September 2012 in accordance with generally accepted government auditing standards. Those standards require that we plan and perform the audit to obtain sufficient, appropriate evidence to provide a reasonable basis for our findings and conclusions based on our audit objectives. We believe that the evidence obtained provides a reasonable basis for our findings and conclusions based on our audit objectives.

Background MRI and CT services are two types of medical imaging that aid in the diagnosis and treatment of myriad diseases and disorders. Medicare reimburses providers for performing the services and, subsequently, interpreting the results. Payment for the performance of the service can be made through different payment systems, depending on where the service is performed. In 2010, 6.8 million MRI and CT services were performed in a physician office or IDTF, representing about 23 percent of all MRI and CT services received by Medicare FFS beneficiaries. CMS has implemented several policies to limit self-referral, and MedPAC and other researchers have proposed further reforms.

MRI and CT Services Medical imaging is a noninvasive process used to obtain pictures of the internal anatomy or function of the anatomy using one of many different types of imaging equipment and media for creating the image. MRI and CT services are two of the six medical imaging modalities.21 MRI services use magnets, radio waves, and computers to create images of internal body tissues. CT services use ionizing radiation and computers to produce cross-sectional images of internal organs and body structures. For certain advanced imaging services, contrast agents, such as barium or iodine solutions, are administered to patients orally or intravenously. By using contrast, sometimes referred to as “dye,” as part of the imaging examination, providers can view soft tissue and organ function more clearly. MRI and CT services help diagnose and treat many diseases and disorders such as different types of cancer, cardiovascular diseases, and musculoskeletal disorders. They can also reduce the need for more- invasive medical procedures and improve patient outcomes.

21The other four imaging modalities are nuclear medicine, ultrasound, X-ray and other standard imaging, and procedures that use imaging.

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Medicare Billing and Medicare payments for advanced imaging services are separated into two Payment Policies for components—the technical component (TC) and the professional Advanced Imaging component (PC). The TC is intended to cover the cost of performing a Services test, including the costs for equipment, supplies, and nonphysician staff. The PC is intended to cover the provider’s time in interpreting the image and writing a report on the findings. The PC and TC can be billed together, on what is called a global claim. The components can also be billed separately. For instance, a global claim could be billed if the same provider performs and interprets the examination, whereas the TC and PC could be billed separately if the performing and interpreting providers are different. Typically, the Medicare payment for the TC is substantially higher than the payment for the PC. For instance, for a CT of the pelvis with dye billed under the 2010 Medicare physician fee schedule, the TC accounted for 79 percent of the total payment, and the PC accounted for 21 percent.

Medicare reimburses providers through different payment systems depending on where the advanced imaging service is performed. When an advanced imaging service is performed in a provider’s office or an IDTF, both the PC and TC are reimbursed under the Medicare physician fee schedule. Alternatively, when the service is performed in an institutional setting, such as a hospital outpatient or inpatient department, the provider is reimbursed under the Medicare physician fee schedule for the PC, while the TC is reimbursed under a different Medicare payment system, according to the setting in which the service was provided. For instance, the TC of an advanced imaging service performed in a hospital outpatient department is reimbursed under the Medicare hospital outpatient payment system, while a service performed in a hospital inpatient setting is reimbursed through a facility payment paid under Medicare Part A.

2010 Advanced Imaging In 2010, Medicare FFS beneficiaries received 30.0 million advanced Utilization by Setting and imaging services, approximately 6.8 million (23 percent) of which were Medicare Physician Fee performed in an IDTF or physician’s office. Of the 6.8 million advanced Schedule Expenditures imaging services performed in an IDTF or physician’s office, 2.9 million were MRI services and 3.9 million were CT services. The remaining 23.2 million advanced imaging services were performed in other settings, such as hospital inpatient or outpatient departments, and their associated TCs were billed through different payment systems (see fig. 1). The total expenditures for all advanced imaging services billed under the Medicare physician fee schedule, including TCs and PCs, reached $4.2 billion in 2010.

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Figure 1: Distribution of Advanced Imaging Services by Modality and Setting, 2010

Select Implemented or Numerous policies have been implemented or proposed by CMS, Proposed Policies MedPAC, or other researchers that are designed to limit self-referral or Designed to Address reduce inappropriate utilization of advanced imaging services. These Utilization or Expenditures policies can affect self-referral or advanced imaging utilization through various means such as prohibiting different types of physician self- Associated with Self- referral, informing beneficiaries of physician self-referral, mandating Referral of Advanced accreditation of staff performing MRI and CT services, improving payment Imaging Services accuracy, reducing payments for self-referred services, and ensuring services are clinically appropriate. One type of physician self-referral arrangement that CMS has prohibited is “per-click” self-referral arrangements where, for instance, a physician leases an imaging machine to a hospital, refers patients for imaging services, and then is paid on a per-service basis by the hospital. CMS has also solicited comments on prohibiting self-referral of diagnostic tests provided as an ancillary service in a physician’s office that are not usually provided during an office visit, because a key rationale for permitting self-referral of such services is that receiving a diagnostic service during the same office visit when a physician orders a test is convenient for beneficiaries. MedPAC, in its June 2010 report to Congress, noted that MRI and CT

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services were performed on the same day as an office visit less than a quarter of the time, with only 8.4 percent of MRI services of the brain being performed on the same day as an office visit.22 Appendix II lists a select number of such policies in addition to these two policies that have been implemented or put forth by CMS, MedPAC, and other researchers.

Self-Referred MRI and From 2004 through 2010, the number of self-referred MRI and CT services performed in a provider’s office and non-self-referred MRI and CT Services and CT services performed in a provider’s office or IDTF increased, with the Expenditures Grew larger increase for self-referred services. Similarly, expenditures for self- referred advanced imaging services also increased over this period, and Overall, While Non- this increase was larger than the changes in expenditures for advanced Self-Referred Services imaging services that were not self-referred. Over the period we reviewed, the share of advanced imaging services that were self-referred and Expenditures also increased overall and across all provider specialties we examined. Grew Slower or

Decreased

Number of Self-Referred While the number of self-referred MRI services performed in a provider’s and Non-Self-Referred MRI office and non-self-referred MRI services performed in a provider’s office or IDTF both increased from 2004 through 2010, a significantly larger and CT Services Increased 23 Overall from 2004 to 2010, increase occurred among the self-referred services. Specifically, the number of self-referred MRI services increased from about 380,000 with the Larger Increase services in 2004 to about 700,000 services in 2010—an increase of more among Self-Referred than 80 percent (see fig 2). In contrast, the number of non-self-referred Services MRI services grew about 12 percent over the same time period, from about 1.97 million services in 2004 to about 2.21 million services in 2010. Despite an overall increase during this time, both self-referred and non- self-referred services declined at some point during the years of our study. However, the number of self-referred services grew faster in the

22Medicare Payment Advisory Commission, Report to Congress: Aligning Incentives in Medicare (Washington, D.C.: June 2010). 23As noted in the Scope and Methodology section, the universe of services for this finding refers to advanced imaging services performed in a provider’s office or in an IDTF. We focused on these settings because our previous work showed rapid growth among such services and because the financial incentive for providers to self-refer is most direct when the service is performed in a physician office.

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earlier years and declined less in the later years than the number of non- self-referred services.

Figure 2: Number of Self-Referred and Non-Self-Referred MRI Services, 2004-2010

Note: Results include services performed in a physician office or IDTF. Services performed in other settings, such as hospital outpatient departments, are not included.

Similar to MRI services, the number of self-referred and non-self-referred CT services both increased from 2004 through 2010, with a considerably larger increase occurring in self-referred services. Specifically, the number of self-referred CT services more than doubled from 2004 through 2010, growing from about 700,000 services to about 1.45 million services (see fig. 3). In contrast, the number of non-self-referred CT services increased about 30 percent during these years, from about 1.90 million services to about 2.48 million services. Although the number of both self-referred and non-self-referred CT services increased over the period of our study, the number of non-self-referred CT services decreased from 2009 through 2010.

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Figure 3: Number of Self-Referred and Non-Self-Referred CT Services, 2004-2010

Note: Results include services performed in a physician office or IDTF. Services performed in other settings, such as hospital outpatient departments, are not included.

The number of self-referred advanced imaging services increased from 2004 through 2010, even after accounting for change in the number of Medicare FFS beneficiaries. Specifically, the number of self-referred MRI services per 1,000 Medicare FFS beneficiaries grew from 10.8 in 2004 to 20.0 in 2010—an increase of about 85 percent. Similarly, the number of self-referred CT services per 1,000 Medicare FFS beneficiaries more than doubled, growing from about 19.6 in 2004 to 41.2 in 2010.

Self-Referred MRI and CT Expenditures for self-referred MRI services grew overall from 2004 Expenditures Grew More through 2010, while expenditures for non-self-referred MRI services Than Non-Self-Referred declined. Specifically, self-referred MRI expenditures grew about Expenditures Overall with 55 percent during the time of our review, from approximately $239 million in 2004 to about $370 million in 2010 (see fig. 4). In contrast, Non-Self-Referred MRI expenditures for non-self-referred MRI services decreased about Expenditures Declining 8.5 percent during the same period. Expenditures for both self-referred

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and non-self-referred MRI services increased rapidly from 2004 through 2006, then decreased sharply in 2007. These declines in 2007 corresponded with the first year of implementation of a DRA provision that reduced fees for certain advanced imaging services.24 Since the declines in 2007, expenditures for non-self-referred MRI services have declined further while self-referred expenditures have increased.

24Under a provision in the DRA, Medicare fees for certain imaging services covered by the Medicare physician fee schedule cannot exceed what Medicare pays under the hospital outpatient prospective payment system, effectively mandating reduction in fees for certain services. Pub. L. No. 109-171, § 5102(b), 120 Stat. 4, 39-40 (2006). See GAO, Medicare: Trends in Fees, Utilization, and Expenditures for Imaging Services before and after Implementation of the Deficit Reduction Act of 2005, GAO-08-1102R (Washington, D.C.: September 26, 2008).

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Figure 4: Self-Referred and Non-Self-Referred MRI Expenditures, 2004-2010

Note: Expenditures include those services we could determine were performed in a physician office or IDTF setting. This included global claims where the performance and interpretation of the advanced imaging service were billed together—and claims where the performance of the advanced imaging service was billed separately from the interpretation of the image. We excluded expenditures for claims where the interpretation of the exam was billed separately because this service may have been performed in another setting, such as a hospital outpatient department.

Relative to 2004, expenditures for both self-referred and non-self-referred CT services have grown through 2010, but the increase was larger for self-referred CT services (see fig. 5). Specifically, expenditures for self- referred CT services increased from $204 million in 2004 to about $340 million in 2010, an increase of about 67 percent. In contrast, expenditures for non-self-referred CT services increased from about $609 million in 2004 to about $642 million in 2010, an increase of about 5 percent.

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Figure 5: Self-Referred and Non-Self-Referred CT Expenditures, 2004-2010

Share of Self-Referred MRI Because the self-referred advanced imaging services grew at a greater and CT Services Increased rate than non-self-referred services from 2004 through 2010, the Overall and across All proportion of MRI and CT services that were self-referred increased Major Referring Provider during that time period. Specifically, the proportion of MRI services that were self-referred increased from 16.3 percent in 2004 to 24.2 percent in Specialties 2010. Similarly, the proportion of CT services that were self-referred grew from 26.8 percent in 2004 to 37.0 percent in 2010. Consistent with the overall trend, the proportion of MRI and CT services that were self- referred increased from 2004 through 2010 for all provider specialties that

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we studied.25 For further information on self-referral rates across provider specialties, see appendix III.

Self-Referring We found that, in 2010, providers that self-referred beneficiaries for MRI and CT services referred substantially more of those services than did Providers Referred providers who did not self-refer these services, even after we accounted Substantially More for differences in practice size, specialty, geography, and patient characteristics. We also found that the year after providers purchased Advanced Imaging MRI or CT equipment, leased MRI or CT equipment, or joined a group Services on Average practice that self-referred, they increased the number of services they referred when compared with providers that did not begin to self-refer Than Did Other advanced imaging services.

Providers

Self-Referring Providers In 2010, self-referring providers referred substantially more advanced Referred Substantially imaging services than providers who did not self-refer such services that More MRI and CT Services year.26 Specifically, providers that self-referred at least one beneficiary for Than Other Providers, an MRI service in 2010 averaged 36.4 MRI referrals, compared with an average of 14.4 MRI referrals for non-self-referrers. Similarly, providers Regardless of Practice or that self-referred at least one beneficiary for a CT service in 2010 Patient Characteristics averaged 73.2 CT referrals, or 2.3 times as many as the 32.3 CT referrals averaged by non-self-referring providers. About 10 percent of all MRI and CT services referred by self-referring providers in 2010 were ordered, performed, and interpreted by the same provider. Certain efficiencies may be gained when the same provider orders, performs, and interprets an advanced imaging service, such as reviewing a patient’s clinical history only once. CMS has taken steps to ensure that fees for services paid under the physician fee schedule take into account efficiencies that

25We included specialties that referred at least 1.5 percent of self-referred MRI or CT services in 2004 and 2010. Sixteen provider specialties met these criteria for MRI services, CT services, or both types of services. These specialties were Cardiology, Family Practice, Gastroenterology, General Surgery, Hematology/Oncology, Internal Medicine, Medical Oncology, Neurology, Neurosurgery, Physical Medicine, Pulmonary Disease, Orthopedic Surgery, Otolaryngology, Radiation Oncology, Rheumatology, and Urology. 26As discussed earlier, the scope of services included in this analysis is broader than our analysis of self-referred services. Specifically, this analysis includes settings other than a physician office or IDTF, such as a hospital. We did this to fully capture the advanced imaging referral patterns of self-referring and non-self-referring providers to ensure that the comparison between the groups was comparable.

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resulted from how the services are provided, and we recently recommended that CMS expand these efforts.27

Differences in advanced imaging referrals between self-referring and non- self-referring providers persisted after accounting for differences in practice size, specialty, geography, or patient characteristics.

Practice Size Self-referring providers referred more MRI and CT services than did non- self-referring providers, regardless of differences in practice size. In general, self-referring providers tend to work in practices with a larger number of Medicare beneficiaries. However, in 2010, self-referring providers referred more MRI and CT services than non-self-referring providers regardless of practice size, and the difference in number of services referred generally increased as provider size increased (see table 1). For example, self-referring providers that had 50 or fewer patients referred 1.8 times as many MRI services as did non-self-referring providers. In comparison, self-referring providers with 500 or more patients referred 2.4 times as many MRI services as non-self-referring providers did.

27CMS has a long-standing policy called a multiple procedure payment reduction that is meant to avoid duplicate payments for expenses that are incurred only once when two or more surgical services are furnished together by the same physician during the same operating session. CMS expanded the multiple procedure payment reduction to include certain imaging services in 2006. Medicare Program: Revisions to Payment Policies Under the Physician Fee Schedule for Calendar Year 2006, 70 Fed. Reg. 70116 (Nov. 21, 2005). In our 2009 report, we recommended that CMS expand its efforts to ensure that fees for services paid under the physician fee schedule reflect efficiencies that occur when services are performed by the same physician to the same beneficiary on the same day. See GAO, Medicare Physician Payments: Fees Could Better Reflect Efficiencies Achieved When Services Are Provided Together, GAO-09-647 (Washington, D.C.: July 31, 2009). In 2012, CMS expanded its multiple procedure payment reduction policy by applying a reduction to the PC of imaging services that are provided during the same session, to the same patient, on the same day; the agency had previously applied the multiple procedure payment reduction to only the TC of imaging services that met the same criteria.

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Table 1: Average Number of MRI and CT Services Referred by Non-Self-Referring and Self-Referring Providers, 2010

MRI services CT services Number of unique Relative rate of Relative rate of Medicare FFS self-referring self-referring beneficiariesa Non-self-referring Self-referring providersb Non-self-referring Self-referring providersb 1 to 50 3.2 5.7 1.8 5.2 7.1 1.4 51 to 100 7.2 12.3 1.7 13.7 19.0 1.4 101 to 250 13.0 24.0 1.8 26.7 40.8 1.5 251 to 500 20.4 42.8 2.1 48.7 78.8 1.6 >500 29.7 71.1 2.4 89.9 151.0 1.7

Source: GAO analysis of Medicare data. Notes: Providers were considered to be self-referring if they self-referred beneficiaries for at least one service. Providers with a specialty of radiology or independent diagnostic testing facility (IDTF) were removed from this analysis because they should not be able to self-refer services. Additionally, because emergency medicine providers generally did not practice in provider offices, they were removed from our analysis. Of the 419,884 providers that referred at least one beneficiary for an MRI service in 2010, 35,950 were self-referring and 383,934 were non-self-referring. Of the 477,547 providers that referred at least one beneficiary for a CT service in 2010, 39,913 were self-referring and 437,634 were non-self-referring. aThe number of unique Medicare FFS beneficiaries refers to the number of unique beneficiaries that received at least one service from a provider. bThe relative rate of self-referring providers refers to the factor by which the average number of services referred by self-referring providers is greater than the average number of services referred by non-self-referring providers. For example, if the relative rate of self-referring providers is equal to 3, it would mean that, on average, self-referrers refer 3 times as many advanced imaging services as do non-self-referrers.

Specialty Self-referring providers generally referred more MRI and CT services than did non-self-referring providers, regardless of differences in specialties. Self-referring providers were more likely than non-self-referring providers to belong to specialties that had a greater-than-average number of referrals per physician for advanced imaging services in 2010. However, for the 7 specialties that had at least 1,000 providers that self-referred beneficiaries for MRI services, self-referring providers generally averaged more referrals for MRI services than did non-self-referring providers, regardless of practice size.28 Similarly, self-referring providers in 9 of the

28We grouped providers of each specialty with at least 1,000 self-referring providers into five provider-size categories: (1) fewer than 50 unique Medicare FFS patients; (2) 51-100 unique Medicare FFS patients; (3) 101-250 unique Medicare FFS patients; (4) 251-500 unique Medicare FFS patients; and (5) more than 500 unique Medicare FFS patients. The seven specialties that had at least 1,000 self-referring providers were Family Practice, Hematology/Oncology, Internal Medicine, Neurology, Nurse Practitioners, Orthopedic Surgeons, and Physician Assistants.

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13 specialties that had at least 1,000 self-referring CT providers generally referred more beneficiaries for CT services than non-self-referring providers, regardless of practice size.29

Geography Self-referring providers referred more MRI and CT services than non-self- referring providers, regardless of differences in geography. Providers that self-referred MRI services averaged 36.3 MRI referrals and 37.3 MRI referrals in urban and rural locations, respectively. In comparison, non- self-referring providers averaged 14.3 MRI referrals in urban locations and 15.2 MRI referrals in rural locations. Providers that self-referred beneficiaries for CT services averaged 72.7 referrals in urban locations and 77.2 referrals in rural locations, while non-self-referring providers averaged 31.1 CT referrals in urban locations and 40.7 referrals in rural locations. We found that differences in the number of MRI and CT referrals made by self-referring and non-self-referring providers persisted when accounting for provider size along with geography (see table 2).

29The nine specialties where self-referring providers referred more beneficiaries for CT services than non-self-referring providers across the majority of provider size categories were: Cardiology, Gastroenterology, General Surgery, Hematology/Oncology, Nurse Practitioners, Orthopedic Surgery, Otolaryngology, Urology, and Pulmonary Disease specialists. The four specialties where non-self-referring providers referred more beneficiaries for CT services, on average, than self-referring providers across the majority of provider size categories were Family Practice, Internal Medicine, Neurology, and Physician Assistants.

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Table 2: Average Number of MRI and CT Services Referred by Non-Self-Referring and Self-Referring Providers in Urban and Rural Locations, 2010

MRI services CT services Number of unique Relative rate of Relative rate of Geographic Medicare FFS Non-self- self-referring Non-self- self-referring designation beneficiariesa referring Self-referring providersb referring Self-referring providersb Urban 1 to 50 3.3 5.8 1.8 5.4 7.3 1.4 51 to 100 7.5 12.4 1.7 14.2 19.4 1.4 101 to 250 13.5 24.4 1.8 27.2 41.9 1.5 251 to 500 20.8 43.9 2.1 48.2 80.8 1.7 >500 29.5 72.1 2.4 86.5 151.5 1.8 Rural 1 to 50 2.8 4.7 1.7 4.3 5.2 1.2 51 to 100 5.7 10.2 1.8 10.4 12.7 1.2 101 to 250 10.5 20.1 1.9 23.8 30.3 1.3 251 to 500 19.0 34.6 1.8 51.3 64.7 1.3 >500 30.5 65.4 2.1 102.8 147.8 1.4

Patient Characteristics Self-referring providers referred more MRI and CT services than non-self- referring providers, in spite of similarities in patient characteristics. Specifically, the patient populations of self-referring and non-self-referring MRI and CT providers were similar in terms of most patient characteristics, with self-referring providers having slightly healthier patients than non-self-referring providers, as indicated by their lower average risk score (see table 3). If self-referring providers had patients that were older or sicker, it could have explained why self-referring providers referred their patients for more services than non-self-referring providers.

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Table 3: Patient Characteristics of Non-Self-Referring and Self-Referring MRI and CT Providers, 2010

MRI services CT services Patient characteristics, average Non-self-referring Self-referring Non-self-referring Self-referring Average age (years) 70 71 70 71 Percent female 59 60 59 57 Average risk scorea 1.53 1.40 1.57 1.44

Source: GAO analysis of Medicare data. aA beneficiary’s risk score is a proxy for health status and is equivalent to the ratio of expected health care expenditures for that beneficiary under Medicare FFS relative to the average health care expenditures for all Medicare FFS beneficiaries. For example, a beneficiary with a risk score of 1.05 would have expected expenditures that were 5 percent higher than an average Medicare FFS beneficiary. The risk scores presented are normalized using the FFS normalization factor of 1.041 that CMS used to normalize risk scores in 2010. Normalization keeps the average Medicare FFS risk score constant at 1.0 over time.

Providers’ Referrals for Our analysis indicated that providers’ referrals for MRI and CT services MRI and CT Services substantially increased the year after they began to self-refer. In our Substantially Increased the analysis, we compared the number of MRI and CT referrals for Year after They Began to switchers—those providers that did not self-refer in 2007 or 2008 but did self-refer in 2009 and 2010—to providers that did not change their self- Self-Refer referral status during the same time period. Providers could self-refer by purchasing imaging equipment, leasing equipment, or joining a group practice that already self-referred. Overall, the switcher group of providers who began self-referring in 2009 increased the average number of MRI and CT referrals they made by about 67 percent in 2010 compared to the average in 2008. In the case of MRIs, the average number of referrals switchers made for MRI services increased from 25.1 in 2008 to 42.0 in 2010. In contrast, the average number of MRI and CT referrals declined for providers that did not self-refer and providers who self-referred from 2008 through 2010. This comparison suggests that the increase in the average number of referrals for switchers from 2008 to 2010 was not due to a general increase in the use of imaging services among all providers. (See table 4.)

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Table 4: Change in Average Number of MRI and CT Services Referred, 2008 and 2010

MRI Services CT Services Average Average Average Average Number 2008 2010 Percentage Number 2008 2010 Percentage Provider of referred MRI referred MRI change, of referred CT referred CT change, referral type providers services services 2008 to 2010 providers services services 2008 to 2010 Switchers 2,803 25.1 42.0 67.3 3,329 56.3 93.9 66.7 Non-self-referrers 199,102 20.6 19.2 -6.8 241,097 59.1 58.1 -1.7 Self-referrers 17,753 47.0 45.4 -3.4 19,756 89.6 87.3 -2.6

Source: GAO analysis of Medicare data. Note: We define switchers as those providers that did not self-refer in 2007 or 2008, but did self-refer in 2009 and 2010.

The increase in MRI and CT referrals for providers that began self- referring in 2009 cannot be explained exclusively by factors such as providers joining practices with higher patient volumes, different patient populations, or different practice cultures. Specifically, providers that remained in the same practice from 2007 through 2010, but began self- referring in 2009, also had a bigger increase in the number of MRI and CT referrals than did providers that did not change their self-referral status.30 Providers that remained in the same practice from 2008 through 2010, but began self-referring in 2009 had a 21.0 percent increase in MRI referrals and a 14.4 percent increase in CT referrals.

Higher Use of On the basis of our estimates, Medicare spent about $109 million more in 2010 than the program would have if self-referring providers referred Advanced Imaging advanced imaging services at the same rate as non-self-referring Services by Self- providers of the same specialty and provider size (see fig. 6). This additional spending can be attributed to the fact that self-referring Referring Providers providers referred over 400,000 more MRI and CT services in 2010 than Results in Substantial if they had referred at the same rate as non-self-referring providers of the same size and specialty. Specifically, we estimate there were 143,303 Costs to Medicare additional referrals for MRI services and 283,725 additional referrals for CT services.

30We considered a provider to have remained in the same practice if the entity to which they most commonly referred MRI or CT services remained the same from 2007 through 2010.

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Figure 6: Potential Savings under Alternative Scenario for Self-Referring Providers, 2010

Note: We included imaging expenditures for those specialties that had at least 1,000 self-referring providers. Overall, specialties that met these criteria referred approximately 66 percent of self- referred MRI services and approximately 81 percent of self-referred CT services. Under the alternative scenario, we calculated expenditures for services as if self-referring providers referred MRI and CT services at the same rate as non-self-referring providers of the same specialty and practice size in 2010.

The additional Medicare imaging expenditures attributed to self-referring providers is likely higher than $109 million in 2010.31 This is because a significant portion of self-referring providers are not included in this estimate. Specifically, we limited our analysis to those specialties that had at least 1,000 self-referring providers. Approximately 34 percent of the

31We limited our analysis to expenditures directly related to imaging services. There may be additional costs associated with the increased use of advanced imaging services by self-referring providers, if these imaging services reveal abnormalities that have no clinical relevance or result in unnecessary surgeries. In contrast, increased use of advanced imaging may partially offset some of these direct imaging costs if increased use led to the early detection of disease and resulted in less-invasive and less-costly treatments.

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providers who self-referred beneficiaries for MRI services and 19 percent of the providers who self-referred beneficiaries for CT services belonged to a specialty other than those that met the 1,000 self-referring providers criteria.

Conclusions Advanced imaging services can help in the early detection and aid in the treatment of certain diseases, resulting in less-invasive treatments and improved patient outcomes. The ability of providers to self-refer beneficiaries for these services can, for example, improve coordination of care and help ensure convenient access to these services among beneficiaries. However, our review indicates that some factor or factors other than the health status of patients, provider practice size or specialty, or geographic location (i.e., rural or urban) helped drive the higher advanced imaging referral rates among self-referring providers compared to non-self-referring providers. We found that providers who began to self-refer advanced imaging services—after purchasing or leasing imaging equipment or joining practices that self-referred—substantially increased their referrals for MRI and CT services relative to other providers. This suggests that financial incentives for self-referring providers may be a major factor driving the increase in referrals. These financial incentives likely help explain why, in 2010, providers who self- referred made 400,000 more referrals for advanced imaging services than they would have if they were not self-referring. These additional referrals cost CMS more than $100 million in 2010 alone. To the extent that these additional referrals are unnecessary, they pose an unacceptable risk for beneficiaries, particularly in the case of CT services, which involve the use of ionizing radiation.

Given the challenges to the long-range fiscal sustainability of Medicare, it is imperative that CMS develop policies to address the effect of self- referral on the utilization of and expenditures for advanced imaging services. CMS first needs to improve its ability to identify services that are self-referred. Claims do not include an indicator or “flag” that identifies whether services are self-referred or non-self-referred, and CMS does not currently have a method for easily identifying such services. A systematic method for identifying self-referred advanced imaging services would give CMS the ongoing ability to determine the extent to which these services are self-referred and help the agency identify those services that may be inappropriate, unnecessary, or potentially harmful to beneficiaries. Including a self-referral flag on Medicare Part B claims submitted by providers who bill for advanced imaging services is likely the easiest and most cost-effective approach. Second, we found that about 10 percent of

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advanced imaging services referred by self-referring physicians in 2010 were also performed and interpreted by the same physician. Certain efficiencies may be gained when the same provider orders, performs, and interprets an advanced imaging service, such as reviewing a patient’s clinical history only once. MedPAC recommended in 2011 that CMS should reduce its payments for advanced imaging services in which the same provider refers and performs the service, to account for efficiencies that are realized in these circumstances. This is consistent with previous efforts by CMS to reduce fees for services paid under the physician fee schedule when efficiencies are realized and with our previous recommendation that CMS expand these efforts. Third, if CMS were able to easily identify self-referred services, the agency may be better positioned to implement an approach that ensures the appropriateness of advanced imaging services that Medicare beneficiaries receive—beyond examining the feasibility of such methods, as we recommended in our 2008 report. Approaches for managing advanced imaging utilization could be “front-end” or used before CMS issues payment, such as prior authorization. CMS could also explore back-end approaches used after CMS issues payment, such as targeted audits of self-referring providers that refer a high volume of services.

Recommendations for In order to improve CMS’s ability to identify self-referred advanced imaging services and help CMS address the increases in these services, Executive Action we recommend that the Administrator of CMS take the following three actions:

1. Insert a self-referral flag on its Medicare Part B claims form and require providers to indicate whether the advanced imaging services for which a provider bills Medicare are self-referred or not. 2. Determine and implement a payment reduction for self-referred advanced imaging services to recognize efficiencies when the same provider refers and performs a service. 3. Determine and implement an approach to ensure the appropriateness of advanced imaging services referred by self-referring providers.

Agency Comments HHS reviewed a draft of this report and provided written comments, which are reprinted in appendix IV. In its comments, HHS stated that it would and Our Evaluation consider one of our recommendations but did not concur with our other two recommendations. HHS did not comment on our findings that self- referring providers referred substantially more advanced imaging services

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than non-self-referring providers or our conclusion that financial incentives for self-referring providers may be a major factor driving the increase in referrals for advanced imaging services.

HHS noted that it would consider our recommendation that CMS determine and implement an approach to ensure the appropriateness of advanced imaging services referred by self-referring providers. According to HHS, CMS would consider this recommendation when refining its medical review strategy for advanced imaging services. HHS also indicated that CMS does not have statutory authority to implement some of the approaches discussed in the report. We are pleased that CMS plans to consider this recommendation and note that we did not identify a specific approach, having identified several examples in our report of both front-end and back-end approaches to managing utilization of advanced imaging services. As we reported, CMS could explore back-end approaches used after CMS issues payment, such as targeted audits of self-referring providers. CMS could also explore other approaches the agency determines are within its statutory authority. Further, if deemed necessary, CMS could seek legislative authority to implement promising approaches to managing advanced imaging utilization.

HHS did not concur with our recommendation that CMS insert a self- referral flag on its Medicare Part B claims and require providers to indicate whether the advanced imaging services for which a provider bills Medicare are self-referred or not. According to HHS, CMS believes that a new checkbox on the claim form identifying self-referral would be complex to administer and providers may not characterize referrals accurately. CMS believes that other payment reforms, such as paying networks of providers, hospitals, or other entities that share responsibility for providing care to patients, would better address overutilization. We continue to believe that including an indicator or flag on the claims would likely be the easiest and most cost-effective approach to improve CMS’s ability to identify self-referred advanced imaging services. We do not suggest, nor did we intend, that CMS use the self-referral flag or indicator we recommended to determine compliance with the physician self-referral law. Without a self-referral flag or indicator, CMS will not be able to monitor trends in utilization and expenditures associated with physician self-referral without considerable time and effort. Further, a self-referral flag does not have to be a “checkbox” on the claim and could be a modifier, similar to other modifiers that CMS uses to characterize claims. In addition, HHS did not provide reasons to support CMS’s contention that such a flag would be complex to administer.

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HHS also did not concur with our recommendation that CMS determine and implement a payment reduction for self-referred advanced imaging services to recognize efficiencies when the same provider refers and performs a service. According to HHS, CMS’s multiple procedure payment reduction already captures efficiencies inherent in providing multiple advanced imaging services by the same physician or group practice during the same session. CMS also noted that a further payment reduction may reduce, but not eliminate, the underlying financial incentive to self-refer advanced imaging services and may cause providers to refer more services, in an effort to maintain their income. CMS also noted that providers in a group practice could easily avoid this reduction by having one physician order the service while another furnishes the service. According to HHS, CMS also questions its statutory authority to impose the payment reduction for the subset of physicians who self-refer, citing a prohibition on paying a differential by physician specialty for the same service. Our report shows that self-referring providers generally referred more MRI and CT services, regardless of differences in specialties, and CMS did not indicate how this recommendation would implicate the prohibition on paying a differential by specialty. Additionally, while HHS cites the multiple procedure payment reduction as a means to address certain efficiencies in the delivery of advanced imaging services, these are not the efficiencies targeted by our recommendation. Instead, as noted in our report, our recommended payment reduction would capture those efficiencies gained when the same provider orders and performs an advanced imaging service. Such efficiencies could be captured in a single—rather than multiple—advanced imaging service. This recommendation is also consistent with a 2011 MedPAC recommendation. As noted in our report, this payment reduction would affect about 10 percent of advanced imaging services referred by self- referring providers. As for CMS’s concern about overutilization of advanced imaging services resulting from a payment reduction, CMS could help address this issue by implementing our recommendation to use a flag indicating self-referral to monitor utilization of these services.

On the basis of HHS’s written response to our report, we are concerned that neither HHS nor CMS appears to recognize the need to monitor the self-referral of advanced imaging services on an ongoing basis and determine those services that may be inappropriate, unnecessary, or potentially harmful to beneficiaries. HHS did not comment on our key finding that self-referring physicians referred about two times as many advanced imaging services, on average, as providers who did not self refer. Nor did HHS comment on our estimate that these additional referrals for advanced imaging services cost CMS more than $100 million

Page 27 GAO-12-966 Medicare Self-Referral of Advanced Imaging Services

in 2010 alone. Given these findings, we continue to believe that CMS should take steps to monitor the utilization of advanced imaging services and ensure that the services for which Medicare pays are appropriate.

HHS also provided technical comments that we incorporated as appropriate.

As agreed with your offices, unless you publicly announce the contents of this report earlier, we plan no further distribution until 30 days from the report date. At that time, we will send copies to the Secretary of HHS, interested congressional committees, and others. In addition, the report will be available at no charge on the GAO website at http://www.gao.gov.

If you or your staff has any questions about this report, please contact me at (202) 512-7114 or [email protected]. Contact points for our Offices of Congressional Relations and Public Affairs may be found on the last page of this report. GAO staff who made major contributions to this report are listed in appendix V.

James C. Cosgrove Director, Health Care

Page 28 GAO-12-966 Medicare Self-Referral of Advanced Imaging Services

List of Requesters

The Honorable Max Baucus Chairman Committee on Finance United States Senate

The Honorable Chuck Grassley Ranking Member Committee on the Judiciary United States Senate

The Honorable Henry A. Waxman Ranking Member Committee on Energy and Commerce House of Representatives

The Honorable Sander Levin Ranking Member Committee on Ways and Means House of Representatives

The Honorable Pete Stark Ranking Member Subcommittee on Health Committee on Ways and Means House of Representatives

Page 29 GAO-12-966 Medicare Self-Referral of Advanced Imaging Services

Appendix I: Scope and Methods

This section describes the scope and methodology used to analyze our three objectives: (1) trends in the number of and expenditures for self- referred and non-self-referred advanced imaging services from 2004 through 2010, (2) the extent to which the provision of advanced imaging services differs for providers who self-refer when compared with other providers, and (3) the implications of self-referral for Medicare spending on advanced imaging services.

For all three objectives, we used the Medicare Part B Carrier File, which contains final action Medicare Part B claims for noninstitutional providers, such as physicians. Claims can be for one or more services or for individual service components.1 Each service or service component is identified on a claim by its Healthcare Common Procedure Coding System (HCPCS) code, which the Centers for Medicare & Medicaid Services (CMS) assigns to products, supplies, and services for billing purposes. HCPCS codes are also categorized by CMS using the Berenson-Eggers Type of Service (BETOS) categorization system, which assigns HCPCS to broad service categories.2

We limited our universe of services and service components for our study to those for magnetic resonance imaging (MRI) and computed tomography (CT) services. We classified MRI and CT services and service components as those with HCPCS codes included in a BETOS category where the first two digits were equal to “I2”, defined as advanced imaging services. We further limited our universe to only those MRI and CT services that were considered designated health services—services for which, in the absence of an exception, a physician may not make a referral to furnish to an entity with which he has a financial relationship

1Services can have technical components (TC) and professional components (PC). The TC of a service is intended to cover the performance of a test, including the cost of equipment, supplies, and nonphysician staff. In addition, services have a PC, which for advanced imaging services is intended to cover the physician’s time in interpreting an image and writing a report on the findings. The TC and PC of a service can be billed together on the same claim—called a global claim—or separately. 2The BETOS categorization system was developed by CMS primarily for analyzing the growth in Medicare expenditures by broad categories. Each billing code is assigned to only one BETOS category.

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Appendix I: Scope and Methods

without implicating the Stark law.3 Annually, CMS publishes a list of designated health services as part of the physician fee schedule. We also restricted our universe to those HCPCS codes that involved the performance of an advanced imaging service, which can be billed with or separately from the interpretation of a MRI or CT imaging service. We identified 125 HCPCS codes that met these criteria.

Because there is no indicator or “flag” on the claim that identifies whether services were self-referred or non-self-referred, we developed a claims- based methodology for identifying self-referred services. Specifically, we classified services as self-referred if the provider that referred the beneficiary for a MRI or CT service and the provider that performed the MRI or CT service was identical or had a financial relationship with the same entity. We used taxpayer identification number (TIN), an identification number used by the Internal Revenue Service, to determine providers’ financial relationships. The TIN could be that of the provider, the provider’s employer, or another entity to which the provider reassigns payment.4 In order to identify the associated TINs for the referring and performing providers, we created a crosswalk of the performing provider’s unique physician identification number or national provider identifier (NPI)

3Compliance with the physician self-referral law, commonly known as the Stark law, is outside the scope of this report. The Stark law prohibits physicians from making referrals for certain designated health services paid for by Medicare, to entities with which the physicians or immediate family members have a financial relationship, unless the arrangement complies with a specified exception, such as in-office ancillary services. 42 U.S.C. § 1395nn(b)(2). 4Some providers may be associated with TINs with which they do not have a direct or indirect financial relationship and thus would not have the same incentives as other self- referring providers. We anticipate that relatively few providers in our self-referring group meet this description but to the extent that they do, it may have limited the differences we found in utilization and expenditure rates between self-referring and non-self-referring providers.

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Appendix I: Scope and Methods

to the TIN that appeared on the claim and used that to assign TINs to the referring and performing providers.5

We considered global services and separately-billed TCs to be self- referred if one or more of the TINs of the referring and performing provider matched. However, we did not consider separately-billed PCs to be self-referred, even if they met the same criterion. Compared to the payment for the TC of an advanced imaging service, the payment for the PC is relatively small, and thus there is little incentive for providers to only self-refer the PC of a service. As part of developing this claims-based methodology to identify self-referred services, we interviewed officials from CMS, provider groups, and other researchers.

To describe the trends in the number of and expenditures for self-referred and non-self-referred advanced imaging services from 2004 through 2010, we used the Medicare Part B Carrier File to calculate utilization and expenditures for self-referred and non-self-referred MRI and CT services, both in aggregate and per beneficiary. We limited this portion of our analysis to global claims or claims for a separately-billed TC, which indicates that the performance of the imaging service was billed under the physician fee schedule. As a result, the universe for this portion of our analysis are those advanced imaging services performed in a provider’s office or in an independent diagnostic testing facility (IDTF), which both bill for the performance of an advanced imaging service under the physician fee schedule. We focused on these settings because our previous work showed rapid growth among such services and because the financial incentive for providers to self-refer is most direct when the service is performed in a physician office. Approximately one-fifth of all

5The final rule implementing the Health Insurance Portability and Accountability Act established the standard for a unique health identifier for health care providers for use in the health care system and announced the adoption of the NPI as that standard. HIPAA Administrative Simplification: Standard Unique Health Identifier for Health Care Providers, 69 Fed. Reg. 2424 (Jan. 23, 2004) (adding a new subpart D to 45 C.F.R. part 162). Performing physicians were required to include their NPI on any claim submitted to Medicare as of May 23, 2008. Prior to implementation of the NPI, Medicare required providers to submit another type of unique provider identifier called the unique physician identification number. Our methodology for identifying self-referred services was similar to the methodology used by MedPAC for its study of the effect of physician self-referral on use of imaging services within an episode. See Medicare Payment Advisory Commission: Report to the Congress: Improving Incentives in the Medicare Program (Washington, DC, June 2009).

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Appendix I: Scope and Methods

advanced imaging services provided to Medicare FFS beneficiaries were performed in a physician office or IDTF. To calculate the number of Medicare beneficiaries from 2004 through 2010 needed for per beneficiary calculations, we used the Denominator File, a database that contains enrollment information for all Medicare beneficiaries enrolled in a given year. Because radiologists and IDTFs are limited in their ability to generate referrals for advanced imaging services, we removed services referred by an IDTF or radiologist.

To determine the extent to which the provision of advanced imaging services differs for providers who self-refer when compared with other providers, we first classified providers on the basis of the type of referrals they made. Specifically, we classified providers as self-referring if they self-referred at least one beneficiary for an advanced imaging service.6 We classified providers as non-self-referring if they referred a beneficiary for an advanced imaging service, but did not self-refer any of the services. Because radiologists and providers in IDTFs predominantly perform advanced imaging services and have limited ability to refer beneficiaries for advanced imaging services, we removed those providers from our analysis. Additionally, because emergency medicine providers generally did not practice in provider offices, they were removed from our analysis. We assigned to each provider the MRI and CT service and service-components that he or she referred, including those for the performance of an imaging service and those for the interpretation of the imaging service result. If the TC and PC were billed separately for the same beneficiary, we counted these two components as one referred service. As a result, we counted all services that a provider referred, regardless of whether it was performed in a provider office, IDTF, or other setting. We then performed two separate analyses.

First, we compared the provision—that is, the number of referrals made— of MRI and CT services by self-referring providers and non-self-referring providers in 2010, after accounting for factors such as practice size (i.e., the number of Medicare beneficiaries), provider specialty, geography (i.e., urban or rural), and patient characteristics. We used the number of unique Medicare fee-for-service (FFS) beneficiaries for which providers provided services in 2010 as a proxy for practice size, which we identified

6Providers in our analysis that could self-refer include primarily physicians, but also could include other providers, such as nurse practitioners and physician assistants.

Page 33 GAO-12-966 Medicare Self-Referral of Advanced Imaging Services

Appendix I: Scope and Methods

using 100 percent of providers’ claims from the Medicare Part B Carrier File. We defined urban settings as metropolitan statistical areas, a geographic entity defined by the Office of Management and Budget as a core urban area of 50,000 or more population. We used rural-urban commuting area codes—a Census tract-based classification scheme that utilizes the standard Bureau of Census Urbanized Area and Urban Cluster definitions in combination with work-commuting information to characterize all of the nation’s Census tracts regarding their rural and urban status—to identify providers as practicing in metropolitan statistical areas.7 We considered all other settings to be rural. We identified providers’ specialties on the basis of the specialties listed on the claims. These specialty codes include physician specialties, such as cardiology and hematology/oncology, and nonphysician provider types, such as nurse practitioners and physician assistants. We also examined the extent to which the characteristics of the patient populations served by self-referring and non-self-referring providers differed. We used CMS’s risk score file to identify average risk score, which serves as a proxy for beneficiary health status. Information on additional patient characteristics, such as age and sex, came from the Medicare Part B Carrier File claims. To calculate the percentage of advanced imaging services referred by self-referring providers that were referred, performed, and interpreted by the same provider, we summed global advanced imaging claims where the referring and performing provider were the same and claims where the TC and PC were referred and performed separately for the same beneficiary by the same provider. We then divided the total by the number MRI and CT services referred by self-referring providers.

Second, we determined the extent to which the number of MRI and CT referrals made by providers changed after they began to self-refer. Specifically, we identified a group of providers that began to self-refer advanced imaging services in 2009.8 We refer to this group of providers as “switchers” because it represents providers that did not self-refer in 2007 or 2008, but did self-refer in 2009 and 2010. We then calculated the change in the number of MRI or CT referrals made from 2008 (i.e., the

7We considered a location with a rural-urban commuting area code of 1.0, 1.1, 2.0, 2.1, or 3.0 to be a metropolitan statistical area.

8We used 4 years of experience (2007 through 2010) to categorize providers even though we compared referrals in 2008 to 2010 because we wanted to ensure that providers that began self-referring in 2009 did not self-refer for at least the 2 prior years.

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Appendix I: Scope and Methods

year before the switchers began self-referring) to 2010 (i.e., the year after they began self-referring). We compared the change in the number of referrals made by these providers to the change in the number of referrals made over the same time period by providers who did not change whether or not they self-referred advanced imaging services. Specifically, we compared the change in the number of referrals made by switchers to those made by (1) self-referring providers—providers that self-referred in years 2007 through 2010, and (2) non-self-referring providers—providers that did not self-refer in years 2007 through 2010. For each provider, we also identified the most common TIN to which they referred MRI or CT services. If the TIN was the same for all 4 years, we assumed that they remained part of the same practice for all 4 years. We calculated the number of referrals in 2008 and 2010 separately for providers that met this criterion.

To determine the implications of self-referral for Medicare spending on advanced imaging services, we summed the number of and expenditures for all MRI and CT services performed in 2010 by providers of those specialties with at least 1,000 self-referring providers. We then created an alternative scenario in which self-referring providers referred the same number of services as non-self-referring providers of the same provider size and specialty and calculated how this affected expenditures. To do this, we calculated the number of advanced imaging services non-self- referring providers referred per unique Medicare FFS beneficiary for each specialty and practice size. We then multiplied the referral rate times the number of patients seen by self-referring providers of the same practice size and specialty, representing the number of services self-referring providers would have referred if they referred at the non-self-referring rate. To calculate the cost of additional services to Medicare, we multiplied the difference between the self-referred services and the number of services they would have referred if they referred at the same rate as non-self-referring providers by the average expenditures for a MRI or CT service.

Page 35 GAO-12-966 Medicare Self-Referral of Advanced Imaging Services

Appendix I: Scope and Methods

Page 36 GAO-12-966 Medicare Self-Referral of Advanced Imaging Services

Appendix II: Select Implemented or Proposed Policies Designed to Address Self-Referral or Appendix II: Selectthe Utilization Implemented of Advanced Imaging Services or Proposed

Policies Designed to Address Self-Referral or the Utilization of Advanced Imaging Services

Policy approach Description and examples of policies Informing Beneficiaries of Physician Effective January 1, 2011, the Patient Protection and Affordable Care Act of 2010 Self-Referral (PPACA) requires physicians who self-refer MRI, CT, or positron emission tomography services under certain circumstances to inform their patients that they may obtain these services from another provider and provide their patients with a list of alternative providers in their area.a The effect of this requirement on physician self-referral is unclear. The American College of Radiology reports that multiple states had similar requirements in place before the implementation of PPACA.b Mandating Accreditation of Staff In 2008, the Centers for Medicare and Medicaid (CMS) proposed, but did not adopt, a Performing MRI and CT Services requirement that provider office-based imaging practices enroll as independent diagnostic testing facilities (IDTF).c However, the Medicare Improvements for Patients and Providers Act of 2008 requires physicians and other providers to be accredited by a CMS-approved national accreditation organization by January 1, 2012, in order to continue to furnish the technical component of services such as MRI and CT services.d While the intent of this requirement was to improve quality of care, this policy could reduce the number of providers who self-refer if they fail to gain accreditation. However, this policy’s actual effect on self-referral is unclear. Improving Payment Accuracy The Medicare Payment Advisory Commission (MedPAC) has noted that improving the payment accuracy of services could reduce the incentive to self-refer those services by making them less financially beneficial.e Consistent with our previous recommendations, payment rates for MRI and CT services have been reduced several times over the last few years to reflect efficiencies that occur when the same provider performs multiple services on the same patient on the same day.f,g Reducing Payments for Physician In its June 2010 report, MedPAC noted that reducing payments for physician self-referred Self-Referred Services services could limit Medicare expenditures when self-referral occurs and reduce the incentive to self-refer by making it less financially beneficial.h One option put forth in the report is reducing payments for certain self-referred services by an amount equal to the percent expenditures increase due to self-referral. Another option discussed is reducing the payment for self-referred services when they include activities already performed by self-referring physicians, such as reviewing the medical history of a beneficiary. Ensuring Services are Clinically In addition to a similar recommendation from MedPAC, we have recommended CMS Appropriate consider expanding its front-end management capabilities, such as prior authorization— an approach whereby providers must seek some sort of approval before ordering an advanced imaging service.i,j Such policies could limit the increased utilization associated with self-referral by ensuring that self-referred services are clinically appropriate. One researcher suggested expanding postpayment reviews by making imaging a subject for medical review by recovery audit contractors.k,l

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Appendix II: Select Implemented or Proposed Policies Designed to Address Self-Referral or the Utilization of Advanced Imaging Services

Policy approach Description and examples of policies Prohibiting Different Types of Physician CMS has prohibited different types of physician self-referral that the agency deemed Self-Referral particularly susceptible to abuse. Effective October 1, 2009, CMS prohibits “per-click” self-referral arrangements where, for instance, a physician leases an imaging machine to a hospital, refers patients to that hospital in order to receive imaging services, and then is paid on a per service basis by the hospital.m In 2008, CMS considered but did not prohibit “block time” self-referral arrangements where, for instance, a physician leases a block of time on a facility’s MRI or CT machine, refers his or her patients to receive services on the facility’s machine, and then bills for the services.n CMS has also solicited comments on a prohibition against physician self-referral for diagnostic tests provided in physician offices when those tests are not needed at the time of a patient’s office visit in order to assist the physician in determining an appropriate diagnosis or plan of treatment.o MedPAC has found that MRI and CT services are performed on the same day as an office visit less than a quarter of the time, with only 8.4 percent of MRIs of the brain being performed on the same day as an office visit.p Another policy, discussed in MedPAC’s June 2010 report, that would limit physician self- referral is restricting certain types of self-referral to only those practices that are clinically integrated. Maryland prohibits providers from making self-referrals for certain MRI and CT services.q

Source: GAO analysis of select self-referral regulations and proposals. aPub. L. No. 11-148, § 6003, 124 Stat. 199, 697. bAmerican College of Radiology, State-by-State Comparison of Physician Self-Referral Laws, accessed July 26, 2010. cMedicare Program; Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2009, 73 Fed. Reg. 38502, 28533 (July 7, 2008). dPub. L. No. 110-275, §135(a), 122 Stat. 2494, 2532. eSee Medicare Payment Advisory Commission, Report to Congress: Aligning Incentives in Medicare (Washington, D.C.: June 2010). fSee GAO, Medicare Physician Payments: Fees Could Better Reflect Efficiencies Achieved When Services Are Provided Together, GAO-09-647 (Washington, D.C.: July 31, 2009). gFor instance, in 2006, CMS began reducing the payment for the technical component of the lower- priced imaging service by 25 percent when multiple services are performed on contiguous body parts during the same session. See Medicare Program: Revisions to Payment Policies Under the Physician Fee Schedule for Calendar Year 2006, 70 Fed. Reg. 70116 (Nov. 21, 2005). PPACA increased the payment reduction from 25 percent to 50 percent beginning July 1, 2010. Pub. L. No. 111-148, §3135(b), 124 Stat. 119, 437. CMS also expanded this policy beginning January 1, 2012 by reducing payments for the lower-priced professional component of advanced imaging services by 25 percent when two or more services are furnished by the same physician to the same patient, in the same session, on the same day. hSee Medicare Payment Advisory Commission, Report to Congress: Aligning Incentives in Medicare (Washington, D.C.: June 2010). iSee Medicare Payment Advisory Commission, Report to the Congress: Medicare and the Healthcare Delivery System (Washington, D.C.: June 2011). jSee GAO, Medicare Part B Imaging Services: Rapid Spending Growth and Shift to Physician Offices Indicate Need for CMS to Consider Additional Management Practices, GAO-08-452 (Washington, D.C.: June 13, 2008). kDonald H. Romano, “Self-Referral of Imaging and Increased Utilization: Some Practical Perspectives on Tackling the Dilemma,” Journal of the American College of Radiology (2009): 773-779.

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Appendix II: Select Implemented or Proposed Policies Designed to Address Self-Referral or the Utilization of Advanced Imaging Services

lThe stated goal of the recovery audit program is to identify improper payments for services provided to Medicare beneficiaries. Improper payments may be overpayments or underpayments. Overpayments can occur when health care providers submit claims that do not meet Medicare’s coding or medical necessity policies. mMedicare Program; Changes to Disclosure of Physician Ownership in Hospitals and Physician Self- Referral Rules, 73 Fed. Reg. 48434, 48713 (Aug. 19, 2008). nMedicare Program; Changes to Disclosure of Physician Ownership in Hospitals and Physician Self- Referral Rules, 73 Fed. Reg. 48434, 48719 (Aug. 18, 2008). oMedicare Program; Proposed Revisions to Payment Policies Under the Physician Fee Schedule, and Other Part B Payment Policies for CY 2008, 72 Fed. Reg. 38122, 38181 (July 12, 2007). pSee Medicare Payment Advisory Commission, Report to Congress: Aligning Incentives in Medicare (Washington, D.C.: June 2010). qMd. Code Ann., Health Occ. § 1-301(k)(2).

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Appendix III: Self-Referral of MRI and CT Services, by Provider Specialty, in 2004 and Appendix III: Self-Referral2010 of MRI and CT

Services, by Provider Specialty, in 2004 and 2010

The proportion of MRI services and CT services that were self-referred increased from 2004 through 2010 for all provider specialties we examined for our study. We examined all provider specialties that performed a minimum proportion of either self-referred MRI or CT services in 2004 and 2010.1 While this increase across provider specialties is consistent with the overall trend of increased self-referral, the increases varied among provider specialties. For MRI services, increases in the self-referral rate for provider specialties ranged from about 4 percentage points (Internal Medicine) to about 19 percentage points for Hematology/Oncology. Similarly, for CT services, increases in the self-referral rates for provider specialties ranged from about 2 percentage points (Internal Medicine) to over 38 percentage points (Radiation Oncology). (see table 5).

1Specifically, for MRI and CT services, we examined provider specialties that referred at least 1.5 percent of the MRI or CT services that were self-referred in both 2004 and 2010. Specialties we examined referred about 86 percent of self-referred MRI services in 2004 and about 81 percent of self-referred MRI services in 2010. These specialties referred about 82 percent of self-referred CT services in 2004 and about 88 percent of self-referred CT services in 2010.

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Appendix III: Self-Referral of MRI and CT Services, by Provider Specialty, in 2004 and 2010

Table 5: Self-referral Rates of MRI and CT Services for Select Provider Specialties

Change in Change in MRI Self-referral CT self-referral Percentage of Percentage of rate from Percentage of Percentage of rate from MRI services MRI services 2004 to 2010 CT services CT services 2004 to 2010 self-referred self-referred (percentage self-referred self-referred (percentage Specialtya in 2004 in 2010 points) in 2004 in 2010 points) Cardiology n/a n/a n/a 33.5 % 55.4% 21.9 Family Practice 10.8 15.7 4.8 25.0 27.6 2.6 Gastroenterology n/a n/a n/a 18.5 24.0 5.5 General Surgery n/a n/a n/a 21.5 24.8 3.3 Hematology/Oncology 15.3 34.3 19.0 39.8 48.7 9.0 Internal Medicine 12.1 16.1 4.0 27.2 29.0 1.8 Medical Oncology n/a n/a n/a 39.7 51.7 12.0 Neurology 19.7 28.9 9.1 n/a n/a n/a Neurosurgery 20.5 26.1 5.6 n/a n/a n/a Physical Medicine 22.7 29.4 6.7 n/a n/a n/a Orthopedic Surgery 27.1 38.4 11.4 n/a n/a n/a Otolaryngology n/a n/a n/a 21.3 32.4 11.1 Pulmonary Disease n/a n/a n/a 27.8 29.7 1.9 Radiation Oncology n/a n/a n/a 37.7 76.1 38.4 Rheumatology 29.4 38.6 9.2 n/a n/a n/a Urology n/a n/a n/a 27.8 51.2 23.4

Source: GAO analysis of Medicare data. Notes: “n/a” indicates that the provider specialty referred less than1.5 percent of all self-referred services, for MRI or CT services, in either 2004 or 2010. If a provider specialty did not refer at least 1.5 percent of all self-referred services for both 2004 and 2010 for either MRI or CT services, it is not included in the table. aProvider specialties are included in Medicare claims data and are self-reported.

Page 41 GAO-12-966 Medicare Self-Referral of Advanced Imaging Services Appendix IV: Comments from the Department Appendix IV: Commentsof Health and Human Services from the Department of Health and Human Services

Page 42 GAO-12-966 Medicare Self-Referral of Advanced Imaging Services Appendix IV: Comments from the Department of Health and Human Services

Page 43 GAO-12-966 Medicare Self-Referral of Advanced Imaging Services Appendix IV: Comments from the Department of Health and Human Services

Page 44 GAO-12-966 Medicare Self-Referral of Advanced Imaging Services Appendix IV: Comments from the Department of Health and Human Services

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Appendix V: GAO Contact and Staff Acknowledgments Appendix V: GAO Contact and Staff

Acknowledgments

GAO Contact James C. Cosgrove, (202) 512-7114 or [email protected]

Staff In addition to the contact named above, Jessica Farb, Assistant Director; Thomas Walke, Assistant Director; Manuel Buentello; Krister Friday; Acknowledgments Gregory Giusto; Brian O’Donnell; and Daniel Ries made key contributions to this report.

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Please Print on Recycled Paper. Federal Register / Vol. 77, No. 214 / Monday, November 5, 2012 / Notices 66471

measures for viewing by improvement The annual estimate of burden is as teams, the NCC, and HRSA. follows:

Responses Instrument Number of per Total Hours per Total burden respondents respondent* responses response hours

Participant Profile Form ...... 9 12 108 5.0 540 Acute Care Visit Form ...... 9 12 108 10.0 1080 Ambulatory Care Visit Form ...... 9 12 108 10.0 1080

Total ...... 27 ...... 324 ...... 2700 * This burden table has been revised from the one published in the 60-day notice to reflect the accurate count of responses per respondent. The number 12 reflects the number of times a respondent will be approached for data collection annually, not the total number of data collection forms completed as was previously reported.

Written comments and methodologies and definitions that best www.ers.usda.gov/data-products/rural- recommendations concerning the suit their program requirements. urban-commuting-area-codes.aspx). proposed information collection should DATES: The public is encouraged to Using data from the Census Bureau, be sent within 30 days of this notice to submit written comments on the every census tract in the United States the desk officer for HRSA, either by proposed FAR methodology no later is assigned a RUCA code. Codes range email to than January 4, 2013. All public from 1 through 10, with 23 sub codes, [email protected] or by comments received will be available for with code 1 representing the most fax to (202) 395–6974. Please direct all public inspection at HRSA’s ORHP on densely populated urban areas and code correspondence to the ‘‘attention of the weekdays between 8:30 a.m. and 5:00 10 representing rural areas with primary desk officer for HRSA.’’ p.m. commuting to a tract outside an Dated: October 25, 2012. Urbanized Area or Cluster. HRSA ADDRESSES: Comments may be believes that the use of RUCAs allows Bahar Niakan, submitted via email to more accurate targeting of resources Director, Division of Policy and Information [email protected]; mail to Office of Rural intended for the rural population. Both Coordination. Health Policy, Health Resources and ORHP and the Centers for Medicare & [FR Doc. 2012–26935 Filed 11–2–12; 8:45 am] Services Administration, 5600 Fishers Medicaid Services have been using BILLING CODE 4165–15–P Lane, Parklawn Building, 5A–05, RUCAs for several years to determine Rockville, MD 20857; or fax to (301) programmatic eligibility for rural areas 443–2803. inside of metropolitan counties. DEPARTMENT OF HEALTH AND FOR FURTHER INFORMATION CONTACT: ORHP currently considers all census HUMAN SERVICES Questions about this request for public tracts with RUCA codes 4 through 10 to comment can be directed to Steven be rural. While use of the RUCA codes Health Resources and Services Hirsch using the contact information has allowed identification of rural Administration listed above. census tracts in metropolitan counties, Methodology for Designation of SUPPLEMENTARY INFORMATION: among the more than 60,000 tracts in Frontier and Remote Areas the U.S., there are some that are Background extremely large and where use of RUCA AGENCY: Health Resources and Services ORHP was authorized by Congress in codes alone fails to account for distance Administration, HHS. December of 1987 by Section 711 of the to services and sparse population. In Social Security Act [42 U.S.C. 912], and response to these concerns, ORHP has ACTION: Request for public comment on charged with informing and advising designated 132 large area census tracts methodology for designation of frontier HHS on matters affecting rural hospitals with RUCA codes 2 or 3 as rural. These and remote areas. and health care and coordinating tracts are at least 400 square miles in activities within the Department that area with a population density of no SUMMARY: This notice announces a relate to rural health care. more than 35 people per square mile. request for public comment on a Definition of ‘‘rural.’’ ORHP considers There is also a ZIP code-based version methodology derived from the Frontier all nonmetropolitan (nonmetro) of the RUCA codes that is often used for and Remote (FAR) system for counties to be ‘‘rural’’ for the purposes policy analysis, research, and other designating U.S. frontier areas. This of eligibility for its grant programs. Over purposes (see: http:// methodology was developed in a the years, ORHP has funded depts.washington.edu/uwruca/). collaborative project between the Office development of a rational, data-driven Need for definition of ‘‘frontier and of Rural Health Policy (ORHP) in the method to designate rural areas inside of remote.’’ Rural experts, researchers, and Health Resources and Services metropolitan counties. The Rural-Urban others have been calling for an Administration (HRSA); and the Commuting Area (RUCA) codes are used improved way to identify frontier and Economic Research Service (ERS) in the for determining grant eligibility. The remote areas. The most commonly used U.S. Department of Agriculture (USDA). RUCAs, which were developed by standard to date has been to identify While other agencies of the Department Richard Morrill and Gary Hart of the frontier areas as those counties with six of Health and Human Services (HHS) University of Washington and John or fewer people per square mile. and the ERS may in the future choose Cromartie of the USDA’s ERS, are based Researchers and policy experts have to use the FAR methodology to on a sub-county unit, the census tract, noted the shortcomings of this approach demarcate the frontier areas of the U.S., permitting a delineation of what since it relies solely on population there is no requirement that they do so, constitutes rural areas inside density and uses counties as the unit of and they may choose other, alternate metropolitan areas (see: http:// measure despite the great disparity in

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county size across the country (Ciarlo, contemporary U.S., no definition can are significant political entities; (3) 1996). This definition lacks precision. account for every variation; and there seldom change boundaries; (4) are Demand has been growing for a will be areas included or excluded that traditionally used in many reporting statistically based, nationally consistent would seem to many to be erroneously systems and data sets; and (5) are well definition of ‘‘frontier territory;’’ one classified. Therefore, it is necessary to known to the general public, program that is adjustable within a reasonable build some degree of flexibility into any managers, researchers, and politicians. range, and applicable in different definition that will allow users to However, there are significant problems research and policy contexts. The U.S. choose the sub-definition that best suits with county use for many purposes. Congress passed legislation directing the their purpose. The FAR codes described Counties were created by means of Secretary of HHS to issue regulations here allow a range of choices rather than political processes and often are that would define the concept of a dichotomy. It will be up to extremely heterogeneous units where ‘‘Frontier Area’’ to be used in the researchers, policymakers, program aggregate averages of data items end up Telehealth programs (Section 330I(r) of managers, and policy advocates to being unrepresentative of particular the Public Health Service Act, 42 U.S.C. ensure that the codes are applied places within the county. The rural/ 254c–14(r)). The definition proposed appropriately within specific contexts. urban character within many counties below differs in several respects from varies dramatically. For instance, Pima Why is it important to delineate frontier the statutory provision governing the County, Arizona, ranges from an urban areas? Telehealth programs, and thus it will city of over half a million population not be applicable to them. As used in This project seeks to delineate U.S. near its northeast corner to large remote this notice, the term ‘‘frontier’’ denotes territory characterized by very low areas that are extremely sparsely territory characterized by some population density and a high degree of populated along its southwest Mexico/ combination of relatively low remoteness. Such territory lies at one U.S. border. Some large states like population density and high geographic end of the rural-urban continuum and Arizona (114,006 square miles— remoteness. can be generally viewed as a subset of significantly larger than the United In performing analysis for this project, rural. Job creation, population retention, Kingdom) have few counties (17 HRSA intended to create a definition of provision of services such as health counties), while smaller states like ‘‘frontier’’ based on easily explained care, and access to food, clothing, and Virginia (42,769 square miles) have concepts of remoteness and population other consumer items may require many smaller counties (134 counties). sparseness. HRSA’s goal was to create a increased efforts in very rural, remote Counties vary in size from state to state, statistical delineation that will be useful communities. Recent research indicates with the counties in the west generally in a wide variety of research and policy that the demographic and economic much larger than those of the east. contexts and adjustable to the penalties associated with small size and Some definitions go beyond a simple circumstances in which it is applied. remoteness may be increasing division of counties into rural/urban or We believe that the new geographic (Partridge, 2008). metro/nonmetro categories. For taxonomy should prove useful in Perhaps the fundamental and defining instance, the ERS’ county-based Urban various research and policy challenges facing frontier communities Influence Codes (UICs) consist of a environments, such as rural health care, are the increased per capita costs of dozen codes and uses the Office of regional science, demography, rural providing services. Access to health care Management and Budget’s definition of sociology, and agricultural economics. is a primary concern motivating this metropolitan to divide the nation’s Two features distinguish the research, but distance and low urban-like and rural-like counties into methodology described here from earlier population densities increase costs of two groups. The taxonomy divides the classifications. First, the approach providing all types of social and public nonmetro counties into 10 categories. strives for the most accurate measures of services, including schools, police and The most frontier-like of these distance possible for the smallest units fire protection, public utilities, and categories (i.e., category number 12) of geography containing population transportation. could be considered as possible frontier/ data. Travel time by car to nearby urban remote areas, but because it uses a Placing Frontier Definitions in a areas is calculated for coterminous U.S. county level analysis, the use of UIC Broader Rural Context territory at the 1x1 kilometer grid level still mischaracterizes some areas within (11.9 million grid cells). Once frontier For purposes of this project, ‘‘frontier/ counties that have a high degree of territory is delimited at the grid level, remote’’ is generally considered a subset heterogeneity in terms of their degree of frontier populations may be aggregated of ‘‘rural.’’ Of course, there are many being frontier/rural. to ZIP code areas, as demonstrated here, definitions of ‘‘rural’’ and as much ‘‘The choice of definition for ‘rural’ or to census tracts, counties, or other disagreement about them as there is that is used to present demographic and useful geographic units. Second, travel about frontier. Many of the rural health data can make a substantive time thresholds around urban areas taxonomies have multiple categories, difference. For example, whether a were allowed to vary by urban-area some of which can be used and disproportionate number of rural population size. This is desirable evaluated for their utility in designating residents are elderly depends on how because the effect of urban population frontier/remote areas. Only by defining rural is defined. Furthermore, wide size on adjacent rural population ‘‘rural’’ appropriately can policymakers variations in health status indicators density is not uniform across all urban better understand the implications of within non-metro areas will not be sizes. In general, the higher the certain policy options. The definition of apparent unless non-metro data are population of an urbanized area, the rurality used for one purpose may be disaggregated by region, urbanization, greater the population density of any inappropriate or inadequate for another proximity to urban areas, or other given area nearby. (Larson and Hart, 2003). relevant factors,’’ (Hewitt, 1989). However, any statistical delineation of Most of the rural definitions are based Depending on which categorization is this nature is approximate at best, and on counties (or their equivalents) as the chosen, estimates of the rural not suited to all applications. Given the geographic unit. The most important population of the U.S. can vary widely. remarkable diversity of settlement reasons for using counties include that Such differences make reported patterns and conditions across the they: (1) Have much available data; (2) information vastly different depending

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on which definition is employed. Census, Frank Popper published a series Many of the listed factors have a face Although having ‘‘rural’’ definitions that of academic and news articles in which validity that is quite obvious. For differ in geographic units and criteria is he applied the term frontier to all instance, society’s perception of rural not inherently bad because they may be sparsely settled territory, as many others areas is that they are those places where used for different purposes, this were doing, and his research showed the population settlement pattern example does demonstrate that they can that more than half the land area of the demonstrates low density (i.e., sparsely lead to considerably different U.S. was still frontier. He also claimed settled areas). populations being designated. that the number of frontier communities Geographic Taxonomy Development There are some taxonomies that are was growing because of persistent Concerns based on sub-county units. The oldest population loss throughout the nation’s and most used such geographic heartland (Popper, F.J., 1986). Social The ORHP/ERS-funded frontier taxonomy is that of the U.S. Census scientists and others are increasingly taxonomy project to develop a needed Bureau. This utilizes census tract and using the term ‘‘frontier’’ to describe national definition of ‘‘frontier’’ and block group data to define Urbanized sparsely settled and geographically ‘‘remote’’ was started in 2008, and Areas and Urban Clusters (described remote territory, especially in the U.S. included the following components: below). The other taxonomy that has (Duncan, 1993; McGranahan and Beale, (1) Creation of a comprehensive gained significant use, especially related 2002). On the federal and state health review and inventory of rural and to health care, is the RUCAs, which care front, frontier came to have a frontier definitions; were described above. general meaning similar to that (2) Establishment and use of a There are many different types of advocated by Popper (i.e., sparsely Technical Advisory Group (five ‘‘rural’’ and ‘‘frontier’’ definitions. Many settled) with remoteness often academic experts), conference calls, and of these definitions were developed in emphasized. ‘‘In the mid-1980s, the other communication and feedback; response to specific needs, but this is federal Community Health Center (3) Formation and use of a not always considered when they are program decided to consider as frontier Stakeholder Advisory Group (seven applied to other tasks and different those counties with a population less relevant stakeholders), conference calls, purposes. Deciding which ‘‘rural’’ than or equal to six persons per square and other communications and definition to apply to a research or mile located at considerable distance feedback; policy analysis topic depends on the (greater than 60 minutes travel time) to (4) Planning and implementing five purpose at hand, the availability of data, a medical facility able to perform a regional stakeholder meetings in and the appropriate and available caesarian section delivery or handle a Washington (District of Columbia), taxonomy. All currently available patient having a cardiac arrest. These Albuquerque (New Mexico), Omaha definitions of ‘‘rural’’ have their latter criteria were forgotten through the (Nebraska), and two in Seattle limitations, however the approach years, and programs began to define (Washington)—one of which was more described in this notice is intended to frontier counties with only a single specifically about islands. Meetings provide an empiric approach to the criteria—population density of six were limited to approximately 30 definition of ‘‘frontier’’ and ‘‘remote.’’ persons per square mile or less,’’ stakeholders. In addition, many other Although it is unlikely that all (Definition of Frontier section of presentations with time for feedback researchers, analysts, and advocates will following web page accessed 4/21/2011: were made (e.g., presentations to the ever agree that a single definition of http://frontierus.org/defining.php). For a Frontier Partners Group); ‘‘rural’’ is appropriate in all bibliography, demographics, federal (5) Analytical testing of the alternate circumstances, we believe that the programs, and other materials related to approaches and results; approach below may provide interested (6) Solicitation of feedback regarding frontier, see the National Center for parties with an additional instrument to approaches and results; Frontier Communities Web site (http:// gauge the relative rurality of an area. (7) Selection of final methodological frontierus.org/). approach; and General Review of the Frontier Concept It is clear from an overview of the (8) Analyses using final methodology The ‘‘frontier’’ definition discussed literature that a fairly small group of on 2000 data. here is a geographical concept meant to factors have a tendency to be included All the components have been delineate areas characterized primarily in most of the rural and frontier completed. by remoteness. Applying this particular taxonomies. The Census Bureau used meaning to the term has increased in population density (areas of less than Frontier and Remote (FAR) recent years, especially in the rural two people per square mile) exclusively Methodology health policy arena, and represents a in its 19th century definition. In To assist in providing policy-relevant natural evolution of the term with contemporary applications, geographic information about conditions in remote parallels in other disciplines (as remoteness has been equally areas to policymakers, public officials, described below). Though a more emphasized. For instance, McGranahan researchers, and the general public, neutral label, such as ‘‘remote areas’’ and Beale (2002) identified a set of ORHP has helped fund the development could easily be substituted, there are frontier counties based on two measures of a set of ZIP code-level frontier codes benefits to use of the term ‘‘frontier’’ for applied to nonmetro counties: by ERS. several reasons, one being the use of a Population density (less than 10.1 The term ‘‘frontier’’ is used here to shorter, more intuitively appealing persons per square mile) and non- describe territory characterized by some descriptive label in research adjacency to a metro area as a proxy for combination of low population size and publications and other outlets. remoteness. Many other measures high geographic remoteness. This pilot For geographers and others, the term attempt to capture these overlapping but FAR version, based on 2000 Census ‘‘frontier’’ came to mean not just the line distinct concepts of sparseness and data, provides four separate frontier dividing more densely settled and less remoteness: population size, distance to definitions (Levels), ranging from one densely settled territory, but all of the urban areas (measured in linear miles, that is relatively inclusive (18.0 million less densely settled territory beyond the travel miles, or travel time), and degree people classified as living in frontier line. For example, after the 1980 of urbanization. areas) to a relatively restrictive version

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(4.8 million frontier residents). Different population, 10,000–24,999 population, instance, if a ZIP code area was 70 definitions are necessary because rural and 2,500–9,999 population; minutes from an Urban Area of 105,000 areas experience degrees of remoteness (6) for each of the 11.9 million grid population and 55 minutes from an at differing population levels that affect cells, the information in #4 and #5 Urban Area of 37,000, it would qualify access to different types of goods and above were used to determine frontier as FAR, but if it was 70 minutes from services. A relatively large share of the status for each of the four levels an Urbanized Area of the same population live far from cities providing (described below); population and 29 minutes from an ‘‘high-order’’ goods and services, such (7) the grid-cell populations (now Urban Area of the same size it would as advanced medical procedures, major classified as frontier or non-frontier) not be designated as FAR. Because the household appliances, regional airport were then aggregated to ZIP code areas base cell information used for the hubs, or professional sports franchises. (ZIP code areas used here come from an conterminous states was not available A much smaller, but still significant, ESRI map boundary file reflecting the for Alaska and Hawaii, the designation share of U.S. residents finds it hard to U.S. Postal Service December 2010 process has to be modified and access ‘‘low-order’’ goods and services, inventory); and performed in a more tailored and such as grocery stores, gas stations, and (8) ZIP code areas were assigned as analyst-intensive fashion. A trial of this basic health care needs. Other types of being FAR or not based on whether 50 method indicates that the final goods and services—clothing stores, car percent or more of the populations in designations for these two states will be dealerships, movie theaters—fall their cells were designated as FAR (this for all intents and purposes parallel somewhere in between. was performed for each of the four Level with those of the other 48 states. The Calculation of travel times from urban criteria—described below). final version of the designations for areas was performed for 1x1 kilometer Not only can the cell data be Alaska and Hawaii will be performed grid cells that also included an aggregated and calculated for ZIP code when the 48 states are redone with the estimated 2000 Census population. The areas, but also the same is being done Census designation of Urban Areas with use of these small, 1 square kilometer for census tracts and could be done for 2010 data. cells, allows more accuracy of other types of geographic units. Note Not all cells and populations are measurement than use of larger units, that aggregating the information to connected to larger places by roads. In such as census tracts or county larger geographic units (such as counties many cases, other means of boundaries. Once the frontier status for and states) creates many more units that transportation must be utilized (e.g., all grid cells was determined, the grid- combine both frontier and non-frontier airplanes, trains, ferries, ships, and cell population was aggregated to ZIP populations. boats). This is not only true for the code areas. For each of the four frontier The four FAR Levels are defined as many islands of Hawaii and Alaska, but Levels, the percentage of a ZIP code follows (travel times are calculated one- for many of the other states (e.g., area’s population classified as frontier way by the fastest paved road route): Washington’s San Juan Islands in the (1) Frontier Level 1 areas are 60 was determined. If the majority of the Puget Sound and Massachusetts’ minutes or greater from Census Bureau- Nantucket Island). There are also towns ZIP code areas’ population was defined Urban Areas of 50,000 or more such as Alaska’s Bethel that are not classified as frontier, that ZIP code area population; connected to larger towns/cities by was considered to be a frontier area. (2) Frontier Level 2 areas are 60 roads (i.e., in this case only by air). In Use of the FAR Methodology and minutes or greater from Urban Areas of these cases (e.g., where air flights are associated data can be used to generate 50,000 or more people and 45 minutes necessary), one hour is added to the alternative ‘‘frontier’’ definitions that or greater from Urban Areas of 25,000– road travel time for the area, which is might better fit potential user purposes. 49,999; more than enough for an area to be The FAR codes can also be used in (3) Frontier Level 3 areas are 60 designated as FAR if it can qualify by conjunction with other data, such as minutes or greater from Urban Areas of specific definition level criteria (e.g., to socioeconomic characteristics of 50,000 or more people; 45 minutes or qualify for Level 3, the town would populations, to allow further research greater from Urban Areas of 25,000– need to have fewer than 10,000 analysis or better policy use. 49,999; and 30 minutes or greater from population). For example, Kauai’s A synopsis of the methods for the new Urban Areas of 10,000–24,999; and largest city is Kappa with a 2010 FAR definition is as follows: (4) Frontier Level 4 areas are 60 population of 10,699. The entire island (1) The developmental analyses were minutes or greater from Urban Areas of clearly qualifies as frontier per FAR based on the 2000 Bureau of the Census 50,000 or more people; 45 minutes or Level 1 and Level 2 definitions. Large data; greater from Urban Areas of 25,000– portions of the island (but not all of it) (2) the conterminous U.S. was divided 49,999; 30 minutes or greater from also qualify per the FAR Level 3 (i.e., a into 11.9 million 1x1 kilometer squares Urban Areas of 10,000–24,999; and 15 portion of Kauai’s population reside for analysis; minutes or greater from Urban Areas of greater than 30 minutes travel from a (3) settlement population aggregations 2,500–9,999. city of over 10,000) and Level 4 were based on the Census Bureau’s FAR Level 1 includes a larger definitions. Bethel, Alaska, which is not designated Urbanized Areas and Urban proportion of the population and land connected to other cities and towns via Clusters based on the 2000 Census data; area of the U.S than Level 2, which road with a 2010 population of 17,013, (4) travel times were calculated to the includes more area and population than also qualifies as frontier per the FAR nearest edges of Urbanized Areas of Level 3, etc. Thus, a ZIP code area that Level 1 and Level 2 definitions but not 2500 or greater population (travel times is designated as FAR per the Level 2 by the FAR Level 3 and Level 4 were estimated using speed limits and definition would need to be located an definitions (i.e., the city has greater than the fastest routes were determined and hour or more travel time from the 10,000 population), though surrounding employed in the analyses); nearest edge of the closest Urbanized areas would qualify because of the (5) travel times were calculated to the Area (50,000 or more population), and severe travel barriers (i.e., no roads into nearest Urbanized Areas regarding each also be located 45 minutes travel time town). of the following categories: 50,000 or from the nearest edge of an Urban Area Given that different geographical greater population, 25,000–49,999 of 25,000–49,999 population. For units (e.g., residential ZIP code areas,

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census tracts etc.) would aggregate areas population and land area. The following (3) Maps. differently, a small Gulf island 100 FAR development project data and Web location #2 (Center for Rural yards off Florida with no connecting materials are available to users at the Health, University of North bridge might qualify differently using two cited web locations: Dakota):http://ruralhealth.und.edu/ different geographic units. As indicated Web location #1 (Economic Research frontier/. above, the FAR designations for ZIP Service): http://www.ers.usda.gov/data- (1) Current version of the rural, code areas were based on a criterion of products/frontier-and-remote-area- frontier, and island definition literature 50 percent or greater being designated. codes.aspx. review (this review will continue to be Data will be made available so that users (1) General description of the FAR updated as new material is obtained and can modify this criterion for their own taxonomy; and as new definitions are created); specific purposes (for any or all of the (2) Downloadable files by state and for (2) Detailed description of the level definitions). For example, if the whole nation for residential ZIP developmental project (e.g., summary of federal or state policymakers need to code areas, and census tracks will be regional stakeholder meetings and target a program to ZIP code areas where available (the files will include: composition of advisory groups); the large preponderance of population Identification code; population count; was living in frontier/remote locals, a Level 1, 2, 3, and 4 designation status, (3) Description of the purposes and FAR criterion of 80 percent could be frontier or not based on majority of principles upon which the taxonomy applied. The results for the trial population); percentage of population was developed; application of the FAR Methodology for that meet and do not meet frontier (4) Detailed description of the ZIP codes with 2000 Census data and criteria for each of the levels; land area analytical methods; and Urban Area definitions for the lower 48 designated as frontier/remote by each of (5) Sensitivity analyses, comparisons states and supporting material are the Levels, land area not designated as with other designation methods, maps available on the web. The available frontier/remote by each of the Levels, and the like. tables are by state, the four definition and state where the majority of the The aggregate results are summarized Levels, and in aggregate for both population resides; and below in Table 1.

TABLE 1—AGGREGATE FAR US 2000 CENSUS RESULTS FOR 48 CONTERMINOUS STATES BY DEFINITION LEVEL CATEGORIES

Percent of Level Population population Percent land area

Level 1 ...... 17,960,713 6.5 54.8 Level 2 ...... 12,391,300 4.5 48.8 Level 3 ...... 8,032,822 2.9 43.0 Level 4 ...... 4,782,328 1.7 35.2

The state-level results are available at and Nebraska (10.3%). Note that Alaska only a tool to better delineate those the FAR section of the ERS Web site and Hawaii are not included here but isolated and remote areas in the country (see: http://www.ers.usda.gov/data- will be included in the 2010 version of to help researchers and policy makers products/frontier-and-remote-area- the FAR codes and will undoubtedly better understand the unique codes.aspx). For instance, for the Level appear on the lists. circumstances of this geographic subset. HRSA is now seeking public 1 FAR sub definition, the states in order Dated: October 26, 2012. comments on: from highest to lower for percentages Mary K. Wakefield, (top 10) of frontier population are: (1) The use of a population threshold Administrator. Wyoming (61.2%), Montana (57.7%), of 50,000 as the central place from North Dakota (48.6%), South Dakota which to measure in defining FAR Bibliography (45.4%), Mississippi (39.6%), Nebraska areas; (2) The use of 60 minutes travel time Ciarlo, J.A., J.H. Wackwitz, et al. ‘Focusing on (35.9%), New Mexico (32.4%), Kansas ‘‘Frontier’: Isolated Rural America.’’ Letter (25.4%), Vermont (24.9%), and Iowa from the central place; (3) Whether the 50 percent population to the Field No. 2. Frontier Mental Health (23.5%). The similar top 10 for threshold for assigning frontier status to Services Resource Network. (1996). http:// percentage of land area are: Nevada a ZIP code/census tract is the www.wiche.edu/MentalHealth/Frontier/ (90.1%), Montana (87.5%), Nebraska appropriate level for the four standard letter2.asp (87.2%), South Dakota (86.8%), provided levels; Duncan, D. Miles From Nowhere: Tales From Wyoming (86.7%), North Dakota (4) Other ways of representing urban America’s Contemporary Frontier. (New (86.5%), New Mexico (82.2%), Utah and rural areas; York: Penguin Books. 1993) (81.8%), Kansas (76.9%), and Colorado (5) Alternatives to using grid cells for Hewitt, M. Defining ‘‘Rural’’ Areas: Impact (74.1%). The similar top 10 by total on Health Care Policy and Research. measuring remoteness; (Health Program Office of Technology frontier population are: Texas, (6) Applicability of the FAR Assessment, Congress of the United States. Mississippi, Missouri, Minnesota, methodology to island populations; and Kentucky, Michigan, Iowa, Kansas, 1989). (7) Need for a Census tract and county Larson, Eric H. and Hart, L. Gary. ‘‘Rural Nebraska, and Illinois. The lists for the version of the FAR. Health Workforce Methods and Analysis.’’ other Levels vary. For example, the top Comments on other aspects of the In Larson, Eric H.; Johnson, Karin E.; five regarding percentage of the methodology are welcomed. Norris, Thomas E.; Lishner, Denise M.; population designated as frontier per Commenters are reminded that this is Rosenblatt, Roger A.; and Hart, L. Gary, the Level 4 sub definition are: North only a proposed methodology, and it is State of the Health Workforce in Rural Dakota (26.2%), South Dakota (24.5%), not currently tied to any current federal America: State Profiles and Comparisons. Montana (15.5%), Wyoming (12.9%), program or allocation of resources. It is Seattle, WA: WWAMI Rural Health

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Research Center, University of Washington, than November 14, 2012 and must be NED works through well-established pp. 15–22 (August 2003) identified by Docket ID FEMA–2007– and expanding partnerships within all McGranahan, D. A. & C. L. Beale. 0008 and may be submitted by one of levels of government, the private sector, Understanding Rural Population Loss. the following methods: and international communities. Exercise Rural America, 17: 2–11. (2002) • Federal eRulemaking Portal: http:// Partridge, M.D., D.S. Rickman, et al. ‘‘Lost in support is administered through the Space: Population Growth in the American www.regulations.gov. Follow the NEP. Information regarding the NEP, the instructions for submitting comments. Principal Objectives, and General Hinterlands and Small Cities.’’ Journal of • Economic Geography 8(6):727–757. (2008) Mail/Hand Deliver/Courier: Objectives can be found in the relative Popper, Frank J. The Strange Case of the Regulatory Affairs Division, Office of sections at: http://www.fema.gov/ Contemporary American Frontier, The Chief Counsel, FEMA, 500 C Street SW., national-exercise-program. Yale Review 76: 101–121. (1986) Room 840, Washington, DC 20472– The Federal Advisory Committee Act Prescott, John RV. Boundaries and Frontiers. 3100. requires that notices of meetings of (New York: Rowman and Littlefield, 1978) Instructions: All submissions received advisory committees be announced in Turner, F.J. The Frontier in American must include the words ‘‘Federal the Federal Register 15 days prior to the History. (New York: Henry Holt and Emergency Management Agency’’ and meeting date. This notice of a Company, 1921) the Docket ID FEMA–2007–0008 for this [FR Doc. 2012–26938 Filed 11–2–12; 8:45 am] teleconference of the NAC is published action. Comments received will be BILLING CODE 4165–15–P less than 15 days prior to the posted without alteration at http:// teleconference due to closure of Federal www.regulations.gov, including any government offices during Hurricane personal information provided. Sandy. Since the NAC is meeting via DEPARTMENT OF HOMELAND Docket: For access to the docket to SECURITY teleconference, there will not be an read background documents or undue burden on the public to arrange comments received by the National Federal Emergency Management travel to attend this meeting. Notice of Advisory Council, go to http:// Agency this meeting is also provided on the www.regulations.gov. NAC’s Web site at http://www.fema.gov/ [Docket ID FEMA–2007–0008] FOR FURTHER INFORMATION CONTACT: national-advisory-council. Alexandra Woodruff, Alternate National Advisory Council W. Craig Fugate, Designated Federal Officer, Office of the Administrator, Federal Emergency AGENCY: National Advisory Council, Federal Federal Emergency Management Agency. Management Agency, DHS. Emergency Management Agency (Room [FR Doc. 2012–26964 Filed 11–2–12; 8:45 am] ACTION: Committee Management; Notice 825), 500 C Street SW., Washington, DC BILLING CODE 9111–48–P of Federal Advisory Committee Meeting. 20472–3100, telephone (202) 212–4349, fax (540) 504–2331, and email FEMA– SUMMARY: The National Advisory [email protected]. The National Council will meet by teleconference on Advisory Council Web site is located at: DEPARTMENT OF THE INTERIOR Monday, November 19, 2012. The http://www.fema.gov/national-advisory- Fish and Wildlife Service meeting will be open to the public. council. DATES: The National Advisory Council SUPPLEMENTARY INFORMATION: Notice of [FWS–HQ–IA–2012–N258; will meet Monday, November 19, 2012, this meeting is given under the Federal FXIA16710900000P5–123–FF09A30000] from 1:00 p.m. to 3:00 p.m. EST. Please Advisory Committee Act, 5 U.S.C. App. Endangered Species; Marine note that the teleconference may close (Pub. L. 92–463). The National Advisory Mammals; Receipt of Applications for early if the committee has completed its Council (NAC) advises the Permit business. Administrator of the Federal Emergency ADDRESSES: The meeting will be held by Management Agency (FEMA) on all AGENCY: Fish and Wildlife Service, teleconference. Members of the public aspects of emergency management. The Interior. who wish to obtain the listen-only call- NAC incorporates State, local, and ACTION: Notice of receipt of applications in number, access code, and other Tribal governments, and private sector for permit. information for the public partners’ input in the development and teleconference, please contact the Office revision of FEMA policies and SUMMARY: We, the U.S. Fish and of the National Advisory Council. strategies. FEMA’s Office of the NAC Wildlife Service, invite the public to For information on services for serves as the focal point for all NAC comment on the following applications individuals with disabilities or to coordination. to conduct certain activities with request special assistance on the call, Agenda: The FEMA National endangered species, marine mammals, contact the Office of the National Advisory Council will be meeting by or both. With some exceptions, the Advisory Council as soon as possible. teleconference to discuss the National Endangered Species Act (ESA) and See contact information under FOR Exercise Program (NEP) two-year cycle Marine Mammal Protection Act FURTHER INFORMATION CONTACT section 2013–1014. The Council will discuss (MMPA) prohibit activities with listed below. potential recommendations on the species unless Federal authorization is To facilitate public participation, General Objectives for inclusion in the acquired that allows such activities. members of the public are invited to NEP two-year cycle. The Council will DATES: We must receive comments or comment on the issues to be considered use the specific priorities from the requests for documents on or before by the committee which are available on Principal Objectives as guidelines to December 5, 2012. We must receive the FEMA Web site at http:// develop their recommendations for requests for marine mammal permit www.fema.gov/national-exercise- General Objectives. FEMA’s National public hearings, in writing, at the program. See the additional information Exercise Division (NED) is responsible address shown in the ADDRESSES section provided in the SUPPLEMENTARY for providing exercise guidance and by December 5, 2012. INFORMATION section. Written comments planning support to the Nation’s ADDRESSES: Brenda Tapia, Division of must be submitted in writing no later emergency preparedness community. Management Authority, U.S. Fish and

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Draft Briefing Paper - Defining Frontier Montana Office of Rural Health/Area Health Education Center December 2012

Background

A new methodology for identifying frontier areas has been presented by the United States Department of Agriculture (USDA) and the Office of Rural Health Policy called the Frontier and Remote (FAR) system. The definition has been published in the Federal Register and is open for comment. As Montana is one of the most frontier of all states, the definition has the potential to impact decisions about funding and programs for the state.

According to the National Center for Frontier Communities (NCFC), different organizations utilize different criteria to define frontier communities for their different programmatic purposes. This paper provides an overview of the definitions.

The New Proposed Designation Methodology

Proposed Methodology for Designation of Frontier and Remote Areas (FAR) https://www.federalregister.gov/articles/2012/11/05/2012-26938/methodology-for- designation-of-frontier-and-remote-areas

According to the Federal Register website, this methodology was developed in a collaborative project between the Office of Rural Health Policy (ORHP) in the Health Resources and Services Administration (HRSA); and the Economic Research Service (ERS) in the U.S. Department of Agriculture (USDA). While other agencies of the Department of Health and Human Services (HHS) and the ERS may in the future choose to use the FAR methodology to demarcate the frontier areas of the U.S., there is no requirement that they do so, and they may choose other, alternate methodologies and definitions that best suit their program requirements.

A synopsis of the methods for the new FAR definition is as follows: 1) The developmental analyses were based on the 2000 Bureau of the Census data; 2) the conterminous U.S. was divided into 11.9 million 1x1 kilometer squares for analysis; 3) settlement population aggregations were based on the Census Bureau's designated Urbanized Areas and Urban Clusters based on the 2000 Census data; 4) travel times were calculated to the nearest edges of Urbanized Areas of 2500 or greater population (travel times were estimated using speed limits and the fastest routes were determined and employed in the analyses); 5) travel times were calculated to the nearest Urbanized Areas regarding each of the following categories: 50,000 or greater population, 25,000-49,999 population, 10,000-24,999 population, and 2,500-9,999 population; 6) for each of the 11.9 million grid cells, the information in #4 and #5 above were used to determine frontier status for each of the four levels (described below); 7) the grid-cell populations (now classified as frontier or non-frontier) were then aggregated to ZIP code areas (ZIP code areas used here come from an ESRI map boundary file reflecting the U.S. Postal

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Service December 2010 inventory); and 8) ZIP code areas were assigned as being FAR or not based on whether 50 percent or more of the populations in their cells were designated as FAR (this was performed for each of the four Level criteria—described below).

The term “frontier” is used by the FAR system to describe territory characterized by some combination of low population size and high geographic remoteness. This pilot FAR version, based on 2000 Census data, provides four separate frontier definitions (Levels), ranging from one that is relatively inclusive (18.0 million people classified as living in frontier areas) to a relatively restrictive version (4.8 million frontier residents). The four FAR Levels are defined as follows (travel times are calculated one way by the fastest paved road route);

Frontier Level 1 areas are 60 minutes or greater from Census Bureau defined Urban Areas of 50,000 or more population; Frontier Level 2 areas are 60 minutes or greater from Urban Areas of 50,000 or more people and 45 minutes or greater from Urban Areas of 25,000–49,999; Frontier Level 3 areas are 60 minutes or greater from Urban Areas of 50,000 or more people; 45 minutes or greater from Urban Areas of 25,000–49,999; and 30 minutes or greater from Urban Areas of 10,000–24,999; and Frontier Level 4 areas are 60 minutes or greater from Urban Areas of 50,000 or more people; 45 minutes or greater from Urban Areas of 25,000–49,999; 30 minutes or greater from Urban Areas of 10,000–24,999; and 15 minutes or greater from Urban Areas of 2,500–9,999.

Current Frontier Definitions

There are multiple, accepted definitions of frontier. Definitions of frontier vary by state and federal program depending on the purpose of the project being funded. The National Rural Health Association (NRHA) identifies the following issues in frontier classification that are currently used including: population density, distance from a population center or specific service, travel time to reach a population center or service, functional association with other places, availability of paved roads, and seasonal changes in access to services. In addition, frontier may be defined at the county level, by ZIP code or by census tract. Definitions are copied verbatim from the sources provided.

Department of Health and Human Services Definition of Frontier (2008) http://bhpr.hrsa.gov/shortage/proposedrule/proposedfile.pdf

Frontier Area means those areas identified by the Secretary (through the Frontier Work Group of the Office for the Advancement of Telehealth) as frontier areas, or, until an official list of frontier areas is issued, those U.S. counties or county- equivalent units with a population density less than or equal to 6 persons per square mile.

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The current HRSA [Health Resources and Services Administration] definition of a frontier community is based on population density in each county, specifically having 6 or fewer persons per square mile. In Montana this means that 45 out 56 counties are designated frontier.

National Center for Frontier Communities (NCFC) http://www.frontierus.org/documents/consensus_paper1998.pdf

The “consensus definition” presented by the NCFC weights population density, distance in miles and travel time in minutes from a market-service area. This methodology was formally adopted by the Western Governors' Association. A group of rural and frontier experts from around the United States agreed to use a Consensus Development Process, based on the methodology used by the National Institutes of Health to develop consensus statements.

This definition utilizes a matrix tool for determining frontier status. It establishes a graphic mechanism for scoring population density and isolation/distance. An area receives points for ranges of population density and miles or minutes distant from a market. Using this method, any area which receives a minimum of 50 points will be considered frontier.

Rural-Urban Commuting Area Codes (RUCAs) http://depts.washington.edu/uwruca/

RUCAs, Rural-Urban Commuting Area Codes, are a Census tract-based classification scheme that utilizes the standard Bureau of Census Urbanized Area and Urban Cluster definitions in combination with work commuting information to characterize all of the nation's Census tracts regarding their rural and urban status and relationships. In addition, a ZIP Code RUCA approximation was developed. The Office of Rural Health Policy funded the development of RUCAs, by the WWAMI Rural Research Center at the University of Washington and the Department of Agriculture's Economic Research Service, to designate "Rural" areas.

California’s Frontier Methodology http://www.oshpd.ca.gov/RHSU/About_US/definitions.html

A frontier Medical Service Study Area (MSSA) is the same as a rural MSSA adopted by the California Health Manpower Policy Commission, but with a smaller population density of less than 11 persons per square mile.

Office for the Advancement of Telehealth, Methodology for Designating Frontier Areas (2006) http://ruralhealth.und.edu/pdf/FrontierDefinition_May06.pdf

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Definition of Frontier Area for use associated with programs within the jurisdiction of the Office for the Advancement of Telehealth: ZIP code areas whose calculated population centers are more than 60 minutes or 60 miles along the fastest paved road trip to a short-term nonfederal general hospital of 75 beds or more, and are not part of a large rural town with a concentration of over 20,000 population. A reconsideration process is also recommended as part of the application of this definition.

The following section provides rationale for these elements of the recommended definition of Frontier Area.

Description of proposed characteristics of the definition of Frontier Area Medical facility that is a 75 bed (or more), non-federal short term general hospital, as noted earlier, was chosen because the panel members believed that this size could best serve as a proxy for the availability of a full complement of essential services. More specifically, after considering a range of medical facility characteristics, the Panel members recommended this size and type of facility because it would achieve a minimum range of services and associated physician specialties that could function as a source for telehealth services.

Travel distance in miles to nearest facility or travel time in minutes to nearest facility. Sixty minutes or sixty miles was chosen. In examining distance in mileage and travel time, it was determined that either travel time or distance, combined with going outside of urbanized areas or large cities, adequately addressed the time and distance issues. Panel members believed that exceeding sixty minutes or sixty miles would compromise access to many specialty and critical support services, even with emergency and other medical transportation. Sixty minutes is often referred to in the emergency medical services literature as ‘the golden hour,’ when access to medical care for categories of patients may be critically important. In the test analysis, sixty miles provides little additional refinement to the definition of Frontier Area, but by it its inclusion, incorporates an additional population that would be otherwise excluded using only sixty minutes.

Population density is reflected as less densely settled areas indexed by areas outside of large urban aggregations (either outside of urbanized areas or outside of nonmetropolitan cities with concentrated populations of 20,000 or more) that are 60 minutes or 60 miles from the designated medical facility.

Impact of this approach. Based on 1998 population data, the test analyses suggested that the proposed definition would result in the designation of communities containing approximately 7,000,000 people that would qualify for a “Frontier” preference under the telehealth programs authorized under Public 16 Law 107-251. However, as these characteristics of a Frontier Area definition are applied, results will vary when: 1) all ZIP code areas and updated ZIP code area populations are used instead of the Census Bureau ZCTAs; 2) ZIP code areas, 2000 Census Bureau Urbanized Area definitions

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and designations are updated and employed via the updated version 2.0 RUCAs; 3) hospital information is updated and, 4) the travel distance/time data are updated. If the definition of Frontier Area recommended in this report is adopted, the actual eligibility would need to be more carefully determined using the latest data. It is important to note that the developmental data used (e.g., 1998 populations) were used because they were convenient and economical. Nevertheless, it is anticipated that the findings will not be substantially different in the aggregate as the aforementioned information is updated.

Frontier Extend Stay Clinic Criteria ftp://ftp.hrsa.gov/ruralhealth/FESC_RFP.pdf

The FESC (Frontier Extended Stay Clinic) must be located in a community which is at least 75 miles away from the nearest acute care hospital or critical access hospital or which is inaccessible by public road. This definition was used in order to be considered for a waiver of Medicare provisions.

What does this mean for Montana?

Frontier communities face challenges due to their remoteness and limited availability of important services. It is a difficult task to define rurality and the health status of the rural and frontier communities of Montana. The large geographic size, economic and environmental diversity, and low population density creates a unique health environment within each community. There are several standard health indices used to rank and monitor health in an urban setting that do not translate as accurately in rural and frontier areas. Health status data is reported by county for some health indices and by region for others due to a low overall population density. Thus population density itself makes it a challenge to understand rural health status and access issues. Communities that are designated as frontier may be eligible for funding and grants through state and federal programs to address the unique challenges of areas with low population density as well as being at a distance from larger centers of care.

The proposed FAR methodology could be used to determine eligibility for a wide variety of federal funding and grant opportunities. No definition can account for every variation of communities and populations. The Federal Register has stated that most of the rural definitions are based on counties (or their equivalents) as the geographic unit and the most important reasons for using counties is that they “have much available data” (Source: https://www.federalregister.gov/articles/2012/11/05/2012-26938/methodology-for-designation- of-frontier-and-remote-areas#h-10) However, in states like Montana, there is often not “much available data” even at the county level because low populations make it difficult to report health data.

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Appendix

List of Urban, Rural, & Frontier counties in Montana based on the previous Frontier designation of “6 or fewer persons per square mile.” 45 of Montana’s 56 counties are considered Frontier (2010)

US Census Bureau, Population Density: July 1, 2009, Population Division, Estimates of Population, released March 20, 2010

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Map 1: (2010) Map of Urban, Rural, & Frontier counties in Montana based on the previous Frontier designation of “6 or fewer persons per square mile.” 45 of Montana’s 56 counties are considered Frontier.

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Map 2: (2010) State Definitions of Frontier. NCFC

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The 1998 -2007 Matrix (NCFC) – Consensus Definition

http://www.frontierus.org/documents/consensus_paper1998.pdf

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Map 3: (2010) Frontier counties in the United States based on the previous Frontier designation of “6 or fewer persons per square mile.”

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Map 4: The Four Levels of Frontier areas in the United States based on the newly proposed Frontier designation. *Note: Each of the four levels is a separate map.

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Page 12

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http://www.ama-assn.org/grassroots http://www.ampaconline.org -2625-

BEFORE THE DEPARTMENT OF PUBLIC HEALTH AND HUMAN SERVICES OF THE STATE OF MONTANA

In the matter of the adoption of New ) NOTICE OF ADOPTION AND Rule I (37.86.1201) and amendment ) AMENDMENT of ARM 37.85.207, 37.85.220, ) 37.85.905, 37.86.101, 37.86.104, ) 37.86.105, 37.86.202, 37.86.205, ) 37.86.501, 37.86.1401, 37.86.1701, ) and 37.86.3201 pertaining to primary ) care service enhanced ) reimbursement and birth attendant ) services )

TO: All Concerned Persons

1. On October 25, 2012, the Department of Public Health and Human Services published MAR Notice No. 37-609 pertaining to the public hearing on the proposed amendment of the above-stated rules at page 2131 of the 2012 Montana Administrative Register, Issue Number 20.

2. The department has amended ARM 37.85.207, 37.85.220, 37.85.905, 37.86.105, 37.86.501, 37.86.1401, 37.86.1701, and 37.86.3201 as proposed.

3. As a result of comments, the department has adopted the following rule:

NEW RULE I (37.86.1201) BIRTH ATTENDANT SERVICE (1) "Birth Attendant" means a person that is licensed as a direct entry midwife as defined in Title 37, chapter 27, MCA and ARM Title 24, chapter 111, subchapter 6. (2) Birth attendants may only provide prenatal labor and delivery or postpartum care in a birthing center as defined at ARM 37.86.3001. (3) Reimbursement for birth attendants will be determined in accordance with ARM 37.85.212 for allied service providers.

AUTH: 53-2-201, 53-6-113, MCA IMP: 53-6-101, MCA

4. The department has amended the following rules as proposed, but with the following changes from the original proposal, new matter underlined, deleted matter interlined:

37.86.101 PHYSICIAN SERVICES, DEFINITIONS (1) through (5) remain as proposed. (6) A "primary care physician" for purposes of this rule means a physician with a specialty designation of family medicine, general internal medicine, or pediatric medicine and all subspecialties of these three specialties recognized by the

Montana Administrative Register 24-12/20/12 -2626-

American Board of Medical Specialties, American Board of Physician Specialties, and American Osteopathic Association.

AUTH: 53-6-101, 53-6-113, MCA IMP: 53-6-101, 53-6-113, 53-6-141, MCA

37.86.104 PHYSICIAN SERVICES, REQUIREMENTS (1) through (12) remain as proposed. (13) The department will confirm the self-attestation of the physician. Providers that are found to be eligible for this program are eligible to receive additional reimbursement commencing from the date of confirmation. Confirmation consists of: (a) verification of board certification by the American Board of Medical Specialties, American Board of Physician Specialties, and American Osteopathic Association as a primary care physician as defined in ARM 37.86.101(6); or (b) remains as proposed.

AUTH: 53-2-201, 53-6-113, MCA IMP: 53-2-201, 53-6-101, 53-6-111, 53-6-113, 53-6-141, MCA

37.86.202 MID-LEVEL PRACTITIONER SERVICES, DEFINITIONS For the purpose of these rules, the following definitions will apply: (1) remains as proposed. (2) "Birth Attendant" means a person that is licensed as a direct entry midwife as defined in Title 37, chapter 27, MCA and ARM Title 24, chapter 111, subchapter 6 and is providing prenatal labor and delivery or postpartum care in a birthing center as defined in ARM 37.86.3001. (3) through (5) remain as proposed, but are renumbered (2) through (4). (6) (5) "Mid-level practitioner" means the following professionals: (a) advanced practice registered nurse; and (b) physician assistant; and (c) birth attendant. (7) (6) "Mid-level practitioner services" means those services provided by mid- level practitioners in accord with the laws and rules defining and governing through licensing and certification the practices of advanced practice registered nurses, and physician assistants, and birth attendants. (8) through (16) remain as proposed, but are renumbered (7) through (15).

AUTH: 53-2-201, 53-6-113, MCA IMP: 53-6-101, MCA

37.86.205 MID-LEVEL PRACTITIONER SERVICES, REQUIREMENTS AND REIMBURSEMENT (1) through (6) remain as proposed. (7) Mid-level practitioners under the supervision of a primary care physician and performing primary care services as defined in ARM 37.86.101 and 37.86.104 qualify for enhanced reimbursement as defined at ARM 37.86.105 except that reimbursement must be reduced in accordance with provisions in this rule.

24-12/20/12 Montana Administrative Register -2627-

(7) through (9) remain as proposed, but are renumbered (8) through (10).

AUTH: 53-2-201, 53-6-113, MCA IMP: 53-6-101, MCA

5. The department has thoroughly considered the comments and testimony received. A summary of the comments received and the department's responses are as follows:

COMMENT #1: Several commenters noted that proposed rule amendments concerning primary care physicians are appreciated by the provider community and will permit them to better serve the primary care needs of Montanans.

RESPONSE #1: The department agrees and appreciates the comments.

COMMENT #2: A commenter suggests that the department should amend the proposed rule amendment at ARM 37.86.101(6) which states "A "primary care physician" for purposes of this rule means a physician with a specialty designation of family medicine, general medicine, or pediatric medicine and all subspecialties of these three specialties recognized by the American Board of Medical Specialties." The commenter suggests striking "family medicine, general medicine, or pediatric medicine" and inserting "family medicine, internal medicine or pediatrics."

RESPONSE #2: The language in the proposed rule amendment mirrors the federal rule. Although the comment has merit, the department will not stray from the federal terminology for purposes of adopting this rule amendment.

COMMENT #3: Two comments stated that the proposed rule amendment at ARM 37.86.101(6) uses the term "general medicine" as one of the physician specialties recognized in the rule. The final federal rule uses the term "general internal medicine". The department should amend their rule to reflect this.

RESPONSE #3: The purpose of this rule amendment is to implement federal rules concerning the Affordable Care Act. ARM 37.86.101(6) will be amended to use the term "general internal medicine" to mirror the final federal rule.

COMMENT #4: A commenter noted that physicians with specialties of obstetrics and gynecology should be allowed to participate in this program.

RESPONSE #4: The department will mirror the federal rule which provides enhanced federal participation to state Medicaid programs when enhancing reimbursement to primary care physicians as defined by federal rule. This permits physicians with specialties of family medicine, general internal medicine or pediatric medicine, or any subspecialty thereof to participate. Physicians who do not qualify for enhanced reimbursement under the federal rule will not receive enhanced reimbursement as a result of these rule amendments.

Montana Administrative Register 24-12/20/12 -2628-

COMMENT #5: A commenter stated that the rule amendment should require qualifying providers to become Passport providers.

RESPONSE #5: The purpose of the rule amendment is to implement requirements of the Affordable Care Act. Although the suggestion has merit, the department will not require qualifying providers to become Passport providers at this time.

COMMENT #6: A commenter noted that under the final federal rule state Medicaid programs may enhance the reimbursement to mid-level practitioners that are supervised by physicians who qualify for this program. They expressed concern about how the department will interpret this requirement. The commenter requests the department provide guidance.

RESPONSE #6: The department shares this concern. State Medicaid programs have asked the Centers for Medicare and Medicaid Services for guidance concerning supervision requirements. We are waiting for a response from them and will share it once guidance is received. Because the final federal rule requires mid- level practitioners under the supervision of a qualifying physician to receive enhanced reimbursement, the department will amend ARM 37.86.202 as described below:

"Mid-level practitioners under the supervision of a primary care physician and performing primary care services as defined in ARM 37.86.101 and 37.86.104 qualify for enhanced reimbursement as defined at ARM 37.86.105 except that reimbursement must be reduced in accordance with provisions in this rule."

COMMENT #7: A commenter stated that the department should add additional accreditation bodies to the administrative rule so they mirror those listed in the final federal rule.

RESPONSE #7: The proposed rule amendments at ARM 37.86.101(6) and 37.86.104(13)(a) permit certification exclusively by the American Board of Medical Specialties. This was the only board allowed for certification purposes in the proposed federal rule which the department's proposed rule amendments are based on. The final federal rule requires state Medicaid programs to allow accreditation from the American Osteopathic Association and American Board of Physician Specialties in addition to the American Board of Medical Specialties. The department agrees with this comment and will add the additional accreditation bodies to the final rule at ARM 37.86.101(6) and 37.86.104(13)(a).

COMMENT #8: Two commenters stated that because this program will have an effective date of January 1, 2013 and an implementation date some time thereafter, they are concerned that a mass adjustment of claims will create an administrative burden. They prefer a lump sum payment.

RESPONSE #8: The department will attempt to keep the administrative burden as low as possible. The department will consult with its fiscal intermediary to determine

24-12/20/12 Montana Administrative Register -2629-

the least administratively burdensome solution. Providers will be apprised of how the department will make these payments.

COMMENT #9: Several commenters opposed proposed amendments to define and reimburse birth attendants as mid-level practitioners at ARM 37.86.202. They contend the rules in place presently governing mid-level practitioners are appropriate and should not be amended. They urge the department to only allow advanced practice registered nurses and physician assistants to be considered mid-level practitioners.

RESPONSE #9: Due to the concern voiced by the provider community in opposition to adding birth attendants to the mid-level rules, the department removes the proposed amendments at ARM 37.86.202. The department will instead create a New Rule I (37.86.1201) for birth attendants defining and reimbursing them as allied service providers. The text in New Rule I (37.86.1201) was originally proposed in ARM 37.86.202.

6. These rule amendments are effective January 1, 2013.

/s/ John Koch /s/ Mary E. Dalton acting for Rule Reviewer Anna Whiting Sorrell, Director Public Health and Human Services

Certified to the Secretary of State December 12, 2012

Montana Administrative Register 24-12/20/12 SENATE BILL NO.2

INTRODUCED BY ______

A BILL FOR AN ACT ENTITLED “AN ACT PROHIBITING THE USE OF TANNING DEVICES BY A PERSON UNDER 18 YEARS OF AGE; PROVIDING DEFINITIONS, PROVIDING A PENALTY FOR VIOLATION, AND AMENDING SECTION 45-5-623, MCA”

WHEREAS, melanoma, the most deadly form of skin cancer, has continued to increase its incidence in the United States and worldwide over the last four decades.1 Since 2004, incidence rates of melanoma among Caucasians have increased about 3% per year in both men and women.1 There is an increasing incidence of thicker and more fatal melanomas in a recent analysis using data from the National Cancer Institute’s Surveillance Epidemiology and End Results (SEER) program.2

WHEREAS, melanoma is the most common cancer among people 25-29 years old, and the second most common cancer in adolescents and young adults ages 15-29;3

WHEREAS, THE U.S. Department of Health and Human Services and the World Health Organization (WHO) International Agency of Research on Cancer Panel has declared ultraviolet radiation from the sun and artificial sources, such as tanning beds and sun lamps, as a known cancer causing agent4 and the American Academy of Dermatology supports the WHO recommendation that minors should not use indoor tanning equipment because overexposure to UV radiation can lead to the development of skin cancer.5

WHEREAS, more than 2.3 million teenagers use artificial tanning devices each year, more than 25% of American teenagers have used tanning beds three or more times, and nearly 70% of tanning salon patrons are young Caucasian women ages 16-29.6,7,8

WHEREAS, research shows that the ultraviolet light received from indoor tanning increases a person’s melanoma risk by 75%.9,10,11

WHEREAS in females aged 15-29 years old, the torso/trunk is the most common location for developing melanoma, which may be due to high risk tanning behaviors.12,2

WHEREAS the risk of melanoma is increased by 87% for individuals who started using tanning beds before the age of 35,11 and exposure to tanning beds increases the risk of melanoma, especially in women aged 45 years or younger.13

WHEREAS, it is in the public interest to protect children from the harmful effects of ultraviolet radiation through the use of artificial tanning devices by restricting minors’ access to the devices.

BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF MONTANA:

NEW SECTION. Section 1. Definitions. For purposes of (sections 1 and 2), the following definitions apply: 1. “Minor” means a person less than 18 years of age. 2. “Phototherapy device” means equipment that emits ultraviolet radiation and is used in treating disease. 3. “Tanning device” means any equipment that emits electromagnetic radiation with wavelengths in the air between 200 and 400 nanometers used for the tanning of skin, including: a sunlamp; and a tanning booth or bed. The term does not include a phototherapy device used by a physician. 4. “Tanning facility” means any location, place, area, structure or business that provides persons access to any tanning device.

NEW SECTION. Section 2. Unlawful use of tanning device.

1. Except as provided in subsection (2), it is unlawful for any owner or operator of a tanning facility to allow a minor to use a tanning device. 2. A physician prescribing the use of a phototherapy device for a minor is not subject to the provisions of this section. 3. A person who violates this section is guilty of an unlawful transaction with a minor and is subject to the penalties provided in 45-5-623.

Section 3. Section 45-5-623, MCA, is amended to read:

“45-5-623. Unlawful transactions with children. (1) Except as provided in 16-6-305, a person commits the offense of unlawful transactions with children is the person knowingly does any of the following:

a. Sells or gives explosives to a child under the age of majority except as authorized under appropriate city ordinances; b. Sells or gives intoxicating substances other than alcoholic beverages to a child under the age of majority; c. Sells or gives an alcoholic beverage to a person under 21 years of age; d. Being a junk dealer, pawnbroker, or secondhand dealer, receives or purchases goods from a child under the age of majority without authorization from a parent or guardian; e. Tattoos or provides a body piercing on a child under the age of majority without the explicit in-person consent of the child’s parent or guardian. For purposes of this subsection (1.e), “tattoo and “body piercing” have the meaning provided in 50-48- 102. Failure to adequately verify the identity of a parent or guardian is not an excuse for violation of this subsection (1.e) f. Provides the use of a tanning device at a tanning facility to a minor. For purposes of this subsection (1.f), “minor”, “tanning device”, and “tanning facility” have the meaning provided in section1. Failure to adequately verify the age of a tanning salon patron is not an excuse for violation of this subsection (1.f).

2. A person convicted of the offense of unlawful transactions with children shall be fined an amount not to exceed $500.00 or be imprisoned in the county jail for any term not to exceed 6 months, or both. A person convicted of a second offense of unlawful transactions with children shall be fined an amount not to exceed $1,000.00 or be imprisoned in the county jail for any term not to exceed 6 months, or both.

NEW SECTION. Section 4. Codification instruction. (Sections 1 and 2) are intended to be codified as an integral part of Title 50, and the provisions of Title 50 apply to (sections 1 and 2).

BIBLIOGRAPHY

1American Cancer Society, Cancer Facts and Figures 2012. http://www.cancer.org/Research/CancerFactsFigures/ACSPC-031941

2Linos E, Swetter SM, Cockburn MG, Colditz GA, Clarke CA, Increasing burden of melanoma in the United States. J Invest Dermatol. 2009 Jul; 129 (7): 1666-74. Epub 2009 Jan 8.

3Howlader N, Noone AM, Krapcho M, et al. SEER Cancer Statistics Review, 1975-2008, National Cancer Institute. Bethesda, MD, http://seer.cancer.gov/csr/1975_2009_pops09/, based on November 2010 SEER data submission, posted to the SEER web site 2011.

4U.S. Department of Health and Human Services, Public Health Service, National Toxicology Program. Report on carcinogens, 11th ed.; Exposure to sunlamps or sunbeds.

5Position Statement on Indoor Tanning. American Academy of Dermatology and AAD Association; Amended by the Board of Directors November 14, 2009; http://www.aad.org

6Kwon HT, Mayer JA, Walker KK, Yu H, Lewis EC, Belch, GE .Promotion of frequent tanning sessions by indoor tanning facilities: two studies. J Am Acad Dermatol 2002, 46:700-5.

7Dellavalle RP, Parker ER, Ceronsky N, Hester EJ, Hemme B, Burkhardt DL, et al. Youth access laws: in the dark at the tanning parlor? Arch Dermatol 2003; 139:443-8.

8Swerdlow AJ, Weinstock MA. Do tanning lamps cause melanoma? An epidemiologic assessment. J Am Acad Dermatol 1998; 38:89-98.

9Lazovich D, et al. “Indoor Tanning and Risk of Melanoma: A Case-Control Study in a Highly Exposed Population.” Cancer Epidemiol Biomarkers Prev. 2010 June, 19(6):1557-1568.

10The International Agency for Research on Cancer Working Group on artificial ultraviolet (UV) light and skin cancer. “The association of use of sunbeds with cutaneous malignant melanoma and other skin cancers: A systematic review.” International Journal of Cancer. 2007 March 1;120: 111-1122. 11Cutaneous melanoma attributable to sunbed use: systematic review and meta-analysis. British Medical Journal 2012; 345:e4757.

12Cancer Epidemiology in Older Adolescents & Young Adults. SEER AYA Monograph. Pages 53-57, 2007.

13Ting W, Schultz K, Cac NN, Peterson M, Walling HW. Tanning bed exposure increases the risk of malignant melanoma. Int J Dermatol 2007 Dec; 46 (12): 1253-7.

-END-

ORIGINAL ARTICLE

Increasing Burden of Melanoma in the United States Eleni Linos1,2, Susan M. Swetter2,3,4, Myles G. Cockburn5, Graham A. Colditz6 and Christina A. Clarke1,4

It is controversial whether worldwide increases in melanoma incidence represent a true epidemic. Dramatic increases in incidence in the setting of relatively stable mortality trends have also been attributed to expanded skin screening and detection of biologically indolent tumors with low metastatic potential. To better understand how melanoma incidence trends varied by severity at diagnosis and factors relevant to screening access, we assessed recent United States incidence and mortality trends by histologic type, tumor thickness, and area-level socioeconomic status (SES). We obtained population-based data regarding diagnoses of invasive melanoma among non-Hispanic whites from nearly 291 million person-years of observation by the Surveillance Epidemiology and End Results (SEER) program (1992–2004). Age-adjusted incidence and mortality rates were calculated for SEER and a subset (California) for which small-area SES measure was available. Overall, melanoma incidence increased at 3.1% (Po0.001) per year. Statistically significant rises occurred for tumors of all histologic subtypes and thicknesses, including those 44 mm. Melanoma incidence rates doubled in all SES groups over a 10-year period whereas melanoma mortality rates did not increase significantly. We conclude that screening- associated diagnosis of thinner melanomas cannot explain the increasing rates of thicker melanomas among low SES populations with poorer access to screening. Journal of Investigative Dermatology advance online publication, 8 January 2009; doi:10.1038/jid.2008.423

INTRODUCTION supported by relatively stable trends in melanoma mortality Malignant melanoma is one of the fastest growing cancers for most groups. Promotion of skin screening programs (that worldwide; studies from Europe (Mansson-Brahme et al., is, population-based screening, skin self-examination prac- 2002; de Vries and Coebergh, 2004; Lasithiotakis et al., tices, and routine, opportunistic physician exams) may inflate 2006; Stang et al., 2006), Singapore (Koh et al., 2003) Canada the numbers of cases, particularly those diagnosed at early (Ulmer et al., 2003), and the United States (Dennis, 1999; stage in the initial phases of program implementation, but Hall et al., 1999; Geller et al., 2002) suggest consistent and may also preferentially detect slow growing or clinically dramatic increases in incidence since the 1950s. Yet the insignificant disease. Therefore, to quantify the true burden of underlying causes of these observed trends are widely clinically relevant disease, incidence patterns of thicker debated (Swerlick and Chen, 1996, 1997; Lamberg, 2002; melanomas may be more informative than those for all Florez and Cruces, 2004), with some authors attributing the melanomas combined. rapid rises to environmental risk factors and sun exposure There are several reasons that examining melanoma trends behavior (Diffey, 2004), and others maintaining they result according to socioeconomic status (SES) may be informative. from expanded screening, biopsy (Welch et al., 2005), and Socioeconomic status may be associated with both knowl- reporting of lower-risk melanomas to cancer registries edge about melanoma, as well as access to physician skin (Swerlick and Chen, 1996, 1997; Hall et al., 2003), notions screening, and low SES correlates with poorer health-care access in the United States (Saraiya et al., 2004; Weissman and Schneider, 2005). In the United States, patients from higher SES groups are more likely to be diagnosed with 1Northern California Cancer Center, Fremont, California, USA; 2Department of Dermatology, Pigmented Lesion and Melanoma Program, Stanford melanoma, but patients from lower SES groups, and those University Medical Center, Stanford, California, USA; 3Veterans Affairs Palo with no or substandard health insurance are more likely to Alto Health Care System, Palo Alto, California, USA; 4Stanford have an advanced stage at diagnosis and to die from 5 Comprehensive Cancer Center, Stanford, California, USA; Department of melanoma (Roetzheim et al., 1999; Ortiz et al., 2005; Pollitt Preventive Medicine, University of Southern Calfornia/Keck School of Medicine, Los Angeles, California, USA and 6Washington University School et al., 2008). Therefore, a detailed assessment of time trends of Medicine, Siteman Cancer Center, St Louis, Missouri, USA in melanoma incidence and mortality among lower SES Correspondence: Dr Eleni Linos, Department of Dermatology, Stanford groups can be informative about the underlying changes in University Medical Center, 900 Blake Wilbur Drive, W0069 Stanford, cancer rates among a potentially more poorly screened California 94305, USA. population with more severe disease. Because information on E-mail: [email protected] SES is generally not collected for individual patients by Abbreviations: APC, annual percent change; CI, confidence interval; SES, socioeconomic status; SEER, Surveillance Epidemiology and End Results cancer registries, assessments of melanoma trends by SES, Received 27 August 2008; revised 30 October 2008; accepted 23 November and tumor thickness have not been published, to our knowl- 2008 edge. Moreover, prior analyses of melanoma incidence

& 2009 The Society for Investigative Dermatology www.jidonline.org 1 E Linos et al. Melanoma in the United States

trends have assessed trends for all persons of white race, 17.7–18.8) per 100,000 whereas in 2004 it was 26.3 (95% regardless of ethnicity; however, this classification includes CI: 25.7–27.0) per 100,000. Incidence rates varied more than two distinct groups: non-Hispanic whites who account for 10-fold according to age and gender groups. Among those over 90% of cutaneous melanoma cases in the United States, younger than 65 years, incidence rates were 18.8 cases per and Hispanic whites in whom melanoma rates are very low, 100,000 men and 17.9 cases per 100,000 women. Among but increasing (Cockburn et al., 2006). It is unclear to what men 65 years and older, 73.2 (95% CI: 68.4–78.4) new cases extent this mixing of two groups with heterogeneous per 100,000 were diagnosed in 1992, giving this group both melanoma risks have biased prior estimations of melanoma the highest absolute rate as well as the fastest growing rate trends. incidence rate (APC 4.50% per year), which reached 126.1 The primary aim of this analysis was to update our (95% CI: 120.2–132.4) per 100,000 in 2004. understanding of melanoma trends in recent years, with Among non-Hispanic whites, 37.5% had superficial specific attention to their support of the notion of a possible spreading melanoma (N ¼ 26,461), 7.4% had nodular mela- epidemic. Using data from the national Surveillance, noma (N ¼ 5264), 7.3% had lentigo maligna melanoma Epidemiology, and End Results (SEER) Program, we analyzed (N ¼ 5141), 0.9% had acral lentiginous melanoma incidence and mortality rates for invasive melanoma among (N ¼ 616) and 4.4% had other subtypes (N ¼ 3137). Over non-Hispanic whites according to tumor thickness and 40% of cases (N ¼ 29,977) were missing histologic subtype histologic type, as well as by area SES in a subset of SEER classification (for example, not otherwise specified). Regard- data. less, no significant differences in the proportions of tumors according to histologic subtype were evident over time. The RESULTS incidence rates per 100,000 of superficial spreading mela- In 2004, 7046 new cases of malignant melanoma were noma increased from 7.6 in 1992 to 8.5 in 2004; incidence reported in the 13 SEER registry areas of the United States. rates of nodular melanoma increased from 1.5 in 1992 to 1.7 The vast majority of cases occurred among non-Hispanic in 2004, and rates of lentigo maligna melanoma rose from 1.2 whites (N ¼ 6569, 93%), whereas 3% occurred in Hispanic to 2.0 over the same period. whites, 1% in Asians and Pacific islanders, and less than 1% Overall mortality from malignant melanoma increased at in blacks and American Indians, respectively. Melanoma an annual rate of 0.4% from 1990 to 2004 (Table 1). For men affected both sexes with a male: female ratio of 3:2. Data on and women over 65 years of age, mortality increased by tumor thickness were available for 85% of cancer patients; of 1.7% annually, reaching 14.3 deaths per 100,000 in 2004. these, most were p1 mm (69%) with other thickness Men over 65 years had the fastest increase in mortality over distributions as follows: 17% 1.01–2mm, 9% 2.01–4mm this period (APC 1.9%) reaching 22.7 deaths per 100,000 in and 5% 44 mm. 2004. Mortality rates decreased among persons younger than 65 years at diagnosis (APC—0.9%) remaining low at 1–2 Incidence and mortality trends among non-Hispanic whites deaths per 100,000 (Figure 2). 1992–2004 A total of 70,596 new cases of malignant melanoma Incidence trends by tumor thickness were diagnosed over the study period, which included Melanoma incidence rates increased across all groups of 290,913,376 person-years of observation. Incidence rates of tumor thickness. The overall annual increase in incidence malignant melanoma increased significantly since 1992 ranged from 0.43 to 6.88% per year across the four groups of (Figure 1), with an overall 45% increase and estimated tumor thickness (Table 2). The overall incidence of tumors 3.1% annual percent change (APC; Po0.001). In 1992, the 44 mm thick increased by 3.86% each year (4.10% men, incidence rate was 18.2 (95% confidence interval, CI: 3.30% women). The annual percent increase in incidence was highest for men over 65 years old, 4.50% overall and per thickness categories: 6.88% for melanomas p1 mm, 4.76% for 1.01–2mm, 3.86% for 2.01–4mm, and 5.67% for 44mm tumors. 100 Because complete reporting of tumor thickness improved over the study period, we quantified the potential impact of this change on observed trends. The proportion of melanoma cases missing thickness information dropped from 20% in log incidence 1992–1996 to 12% in 2000–2004, a reduction of approximately 40%. To understand the impact of this change, we 1 reallocated 40% of the missing tumors in 1992–1996 to each 1992 1996 2000 2004 of the groups with known thickness (Table 3) in several Year of diagnosis iterations: (1) proportionally to all thickness categories, which Men 65+ Women 65+ assumes that reporting improved uniformly across all thick- Men 0–64 Women 0–64 ness levels; (2) disproportionately (twice as many cases to Figure 1. Age adjusted incidence of malignant melanoma per 100,000 the 2.01–4mm and 4 mm þ groups), which assumes that according to age and sex 1992–2004. Note: Y axis is logarithmic scale. reporting improved selectively among thicker tumors; and

2 Journal of Investigative Dermatology E Linos et al. Melanoma in the United States

Table 1. Deaths from malignant melanoma, age adjusted (2000 US standard) mortality rate among non-Hispanic whites for 2004: annual percent change in mortality rates 1990–2004 0–64 years 65+ years 0–85+ years

Men No. of deaths from melanoma in 2004 2,168 2,799 4,967 Mortality rate per 100,000 in 2004 2.2 (2.1–2.3) 22.7 (21.9–23.6) 4.8 (4.6–4.9) Trend APC (%), P-value 1.0* 1.9* 0.6*

Women No. of deaths from melanoma in 2004 1,156 1,531 2,687 Mortality rate per 100,000 in 2004 1.2 (1.1–1.2) 8.5 (8.0–8.9) 2.1 (2.1–2.2) Trend APC (%), P-value 0.9* 0.8* 0.1

All No. of deaths from melanoma in 2004 3,324 4,330 7,654 Mortality rate per 100,000 in 2004 1.7 (1.6–1.7) 14.3 (13.8–14.7) 3.3 (3.2–3.3) Trend APC (%), P-value 0.9* 1.7* 0.4* APC, annual percent change in mortality rate. *Statistically significant difference Po0.05.

100 in areas of highest SES were at higher absolute risk of all melanomas. As shown in Figure 3, increasing trends in incidence rates over time were observed across all SES groups and tumor thickness levels. For each of the SES groups and tumor thickness classifications, there was at least a twofold 10 increase in rates comparing the period of 1988–1992 to 1998–2002. Persons living in low SES areas experienced the log mortality highest increases in melanoma incidence, and among the lowest SES group, the steepest rises in melanoma incidence were observed for thicker tumors (2.01–4 and X4.01 mm; 1 Table 4). Mortality rates among different socioeconomic 1990 1994 1998 2002 groups did not change significantly between the two time Date of death periods (data not shown). Men 0–64 Men 65+ Women 0–64 Women 65+ DISCUSSION Figure 2. Age adjusted mortality rates from melanoma per 100,000 Our analysis of almost 300 million person-years and over according to age and sex 1990–2004. 70,000 new cases of malignant melanoma, the largest such assessment to date, suggests a continued rise in new cases of malignant melanoma in the United States. These findings (3) disproportionately to the thinnest tumor category update through 2004 prior reports indicating persistent rises (p1 mm), which assumes that reporting improved selectively in incidence from the 1960s in the United States (Geller et al., among thin tumors. We considered the latter iteration to be 2002; Ries et al., 2002) and are consistent with mounting the most realistic, because most of the cases with missing evidence of similar trends worldwide (Mansson-Brahme thickness information were among high SES groups, which et al., 2002; de Vries et al., 2003a, b; Ulmer et al., 2003; include a higher proportion of thinner tumors. In all Koh et al., 2003; de Vries and Coebergh, 2004; Lasithiotakis iterations, incidence trends remained statistically significant et al., 2006; Stang et al., 2006). Unlike prior large SEER-based across all thickness levels (Table 3). Therefore, we concluded analyses, we were able to assess trends jointly by tumor that trends in missing thickness level did not change the thickness and SES, which allowed for more precise char- interpretation of our findings. acterization of thick melanoma trends in populations likely to be unscreened or with limited access to physician screening. Trends according to socioeconomic status in California We observed that melanoma incidence increased for both A total of 29,792 cases of cutaneous melanoma in the state of men and women across all categories of tumor thickness, California were included in the SES analyses. Persons living including a significant 3.86% annual increase among the

www.jidonline.org 3 E Linos et al. Melanoma in the United States

Table 2. Age adjusted (2000 US standard) incidence of malignant melanoma among non-Hispanic whites and 95% confidence intervals for 2004 according to age and tumor thickness, SEER 1992–2004 Men Women No. of cases Age-adjusted incidence Trend APC (%) No. of cases Age-adjusted incidence Trend APC (%) Tumor thickness (%) rate per 100,000 in 2004 1992–2004 (%) rate per 100,000 in 2004 1992–2004

Age 0–85+ years p1 mm 2,306 (61%) 19.7 (18.9–20.6) 4.84* 1,869 (66%) 14.9 (14.3–15.6) 4.68* 1.01–2mm 499 (13%) 4.3 (3.9–4.7) 2.39* 389 (14%) 3.0 (2.7–3.3) 3.16* 2.01–4mm 318 (8%) 2.8 (2.5–3.1) 2.54* 153 (5%) 1.1 (0.9–1.3) 1.80 X4.01 mm 200 (5%) 1.7 (1.5–2.0) 4.10* 103 (4%) 0.7 (0.6–0.9) 3.30* Unknown 435 (12%) 3.8 (3.4–4.1) 2.88* 297 (11%) 2.3 (2.0–2.6) 2.48* All1 3758 32.3 (31.3–33.4) 2.96* 2811 22.0 (21.2–22.9) 3.21*

0–64 years p1 mm 1,346 (64%) 12.1 (11.4–12.8) 3.42* 1,344 (72%) 12.8 (12.2–13.6) 4.33* 1.01–2mm 273 (13%) 2.5 (2.2–2.8) 0.44 243 (13%) 2.3 (2.0–2.6) 2.91* 2.01–4mm 145 (7%) 1.3 (1.1–1.5) 0.84 75 (4%) 0.7 (0.5–0.9) 0.42 X4.01 mm 100 (5%) 0.9 (0.7–1.1) 1.96 39 (2%) 0.4 (0.3–0.5) 1.40 Unknown 229 (11%) 2.1 (1.8–2.3) 3.66* 177 (9%) 1.7 (1.4–2.0) 2.65* All1 2,093 18.8 (18.0–19.6) 1.68* 1,878 17.9 (17.1–18.7) 2.97*

65+ years p1 mm 960 (58%) 72.6 (68.1–77.4) 6.88* 525 (56%) 29.4 (26.9–32.1) 5.88* 1.01–2mm 226 (14%) 17.1 (15.0–19.5) 4.76* 146 (16%) 7.7 (6.4–9.0) 3.71* 2.01–4mm 173 (6%) 13.2 (11.3–15.3) 3.86* 78 (8%) 4.1 (3.2–5.1) 3.73* X4.01 mm 100 (10%) 7.6 (6.2–9.2) 5.67* 64 (7%) 3.2 (2.5–4.1) 5.10* Unknown 206 (12%) 15.6 (13.6–17.9) 2.14* 120 (13%) 6.4 (5.3–7.7) 2.17* All1 1,665 126.1 (120.2–132.4) 4.50* 933 50.8 (47.5–54.2) 3.84* APC, annual percent change in incidence rate. *Statistically significant difference Po0.05. 1Includes all malignant melanoma, including those for which thickness was not recorded.

thickest tumors (44 mm). Interestingly, this increase did not presumably because of accumulating DNA damage over correlate with a disproportionate increase in nodular time. Melanoma in the elderly may have a different melanomas, which are characterized by rapid growth and biology and altered host immune response, both of may elude early detection. As with prior reports (Geller et al., which could contribute to increased incidence and mortality 2002), incidence increases were most dramatic for men aged (Balch et al., 2001b). Regardless, the pattern of dramatic 65 and older. These observations persisted in analyses increases in melanoma among persons over 65 in the face accounting for improvements in reporting of tumor thickness. of decreasing mortality among younger men and women is When patients were divided according to neighborhood-level notable. SES, increases were noted in all groups, especially those in Some have argued that the rapid rises in melanoma the lowest two quintiles. Importantly, the lowest SES group incidence are indicative of a true epidemic on the basis of demonstrated the steepest rise in the incidence of thick greater ultraviolet radiation-induced carcinogenesis, whereas tumors 44 mm. others insist that the apparent trends are an artifact of Mortality from melanoma continued to increase, improved surveillance, diagnostic scrutiny (Welch et al., especially among men aged 65 and older (approximately 2005), and regular screening (Swerlick and Chen, 1996) 2% increase annually), consistent with previous reports leading to increased diagnosis of thinner tumors with lower (Geller et al., 2002; Ries et al., 2002) although mortality or no metastatic potential. Our findings inform this debate by rates decreased for men and women younger than 65. For showing persistent increases among more fatal, thick all cancers, age is one of the strongest risk factors, (44 mm) tumors and contest the argument that rising

4 Journal of Investigative Dermatology E Linos et al. Melanoma in the United States

Table 3. Sensitivity analysis assessing the impact of improved reporting of tumor thickness on melanoma trends according to tumor thickness Total 1992 1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004

% Missing before correction 15 23 21 20 17 16 15 15 14 13 13 12 12 11 % Missing after correction 12 13 11 11 9 8 15 15 14 13 13 12 12 11

1. Underreporting in 2. Selective underreporting 3. Selective underreporting Annual percent change all thicknesses of thick tumors of thin tumors

1 mm 3.85* 4.14* 3.40* 1–2mm 1.41* 1.76* 2.68* 2–4mm 1.54* 0.25 2.22* 4 mm+ 3.37 1.85* 3.86* Missing thickness 3.14 3.44 3.08* Overall 2.97* 3.08* 2.16 *Statistically significant difference Po0.05.

SES 1 SES 2 SES 3 100 100 100

10 10 10

1 1 1

0.1 0.1 0.1 1988–1992 1998–2002 1988–1992 1998–2002 1988–1992 1998–2002

SES 4 SES 5 100 100

10 10 Tumor Thickness 0.01–1mm 1 1 1.01–2mm 2.01–4mm 0.1 0.1 4.01+mm 1988–1992 1998–2002 1988–1992 1998–2002

Figure 3. Age adjusted incidence of melanoma according to levels of SES (1–5) and by tumor thickness. Note: Y axis in all graphs is log incidence. incidence rates are solely attributable to increased diagnosis However, the proportion of non-Hispanic white adults who of thinner tumors. reported ever having a physician skin examination in Increasing incidence of thicker melanomas has been National Health Interview Surveys conducted in 1992, reported in earlier population-based studies (Dennis, 1999; 1998, and 2000 ranges from only 14 to 21%, and physician Geller et al., 2002) but was not noted in recent regional screening is rare among those without health insurance studies from France (Lipsker et al., 2007) and Germany (Saraiya et al., 2004). Our data showing increases in (Lasithiotakis et al., 2006). This discrepancy may reflect melanoma incidence across all SES groups are consistent variations in patterns of disease presentation or study with previous reports of melanoma increases by census tract methodology differences including smaller sample sizes in poverty level from 1975 to 1999 (Singh et al., 2003). the European studies. Above and beyond diagnostic surveil- However, our findings of increasing incidence in low SES lance, it is possible that reported trends in melanoma have groups, who may have reduced access to health prevention been influenced by patterns of melanoma reporting to cancer education and practices, suggest a true increase in melanoma registries. Although it is likely that reporting of thin tumors did burden independent of screening access. improve over time as physicians realized their reporting Our observations of modest increases in mortality rates in responsibilities, we did not find evidence of selective the presence of dramatic increases in incidence are curious, overreporting of thin tumors among persons of higher SES and are probably not attributable to improvements in groups. Thus, it is unlikely that reporting patterns explain the survival, treatment, or early detection alone. Median survival SES-specific incidence patterns observed here. for late-stage melanoma in the United States has not changed Routine screening for skin cancer is currently recom- appreciably over the past 30 years (Barth et al., 1995), nor mended by the American Cancer Society (Smith et al., 2007). have there been any major innovations in melanoma

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Table 4. Trends over time according to SES and tumor thickness: incidence rate ratio1 comparing period 2 (1998–2002) to period 1 (1988–1992) Women Men All Thickness SES2 0–64 years 65+ years 0–64 years 65+ years 0–64 years 65+ years

p1mm 1 2.24 2.01 2.22 2.70 2.26 2.42 2 1.88 1.97 1.98 2.38 1.93 2.19 3 1.96 1.96 1.89 2.18 1.94 2.13 4 2.08 2.13 1.76 2.13 1.93 2.17 5 1.67 1.84 1.73 1.97 1.69 1.95

1.01–2mm 1 5.25 7.00 4.00 3.97 4.4 4.89 2 3.8 3.89 3.83 8.11 3.5 5.56 3 3.14 3.58 3.09 4.68 3.11 4.24 4 2.36 4.14 2.54 4.06 2.42 4.16 5 2.55 2.44 2.47 3.28 2.5 2.98

2.01–4mm 1 — 12.25 3.33 6.52 5.00 8.3 2 4.00 8.83 5.67 9.75 4.33 9.88 3 2.67 4.45 2.83 4.88 3.00 5.27 4 2.50 2.57 2.25 4.39 2.33 3.48 5 2.25 3.33 2.29 3.05 2.00 3.23

X4.01 mm 1 4.0 4.0 13.0 5.48 8.0 5.38 2 — 4.5 3.33 11.29 4.0 6.71 3 4.0 4.0 3.33 6.69 3.5 5.44 4 2.0 4.13 2.67 5.4 3.0 5.17 5 2.0 4.33 2.67 4.36 2.0 4.31

Unknown3 1 0.45 0.52 0.69 0.85 0.57 0.68 2 0.45 0.58 0.46 0.67 0.45 0.61 3 0.45 0.66 0.42 0.68 0.43 0.64 4 0.40 0.53 0.45 0.68 0.43 0.61 5 0.40 0.53 0.39 0.57 0.39 0.54

All 1 1.68 1.68 1.74 2.07 1.70 1.93 2 1.49 1.71 1.51 1.98 1.50 1.87 3 1.54 1.67 1.43 1.81 1.49 1.81 4 1.50 1.67 1.37 1.88 1.42 1.83 5 1.30 1.55 1.32 1.63 1.31 1.63 SES, socioeconomic status. —used when unable to calculate ratio as denominator is equal to zero. 1Incidence rate ratio was calculated as the number of new cases of melanoma per 100,000 that occurred during period 1 (1998–2002) divided by the number of new cases of melanoma per 100,000 in period 2 (1988–1992). 2Socioeconomic status was divided into 5 quintiles based on an index of neighborhood SES based on characteristics of the census tract of patient residence at the time of diagnosis. SES1 (lowest), SES 5 (highest) (Yost et al., 2001). 3The percentage of cases with missing thickness across SES groups 1 through 5 is: 32, 28, 25, 22, and 21% respectively.

6 Journal of Investigative Dermatology E Linos et al. Melanoma in the United States

treatment (Korn et al., 2008). Although the influence of a importance of complete and accurate reporting of all stage distribution shift toward thinner, more curable tumors melanoma cases by hospitals and private physicians. has occurred in recent decades (Geller et al., 2007), the incidence of thicker melanoma has not declined (Jemal et al., MATERIALS AND METHODS 2001) as supported by our findings of persistent increases in Population melanomas of all thicknesses over the study period. Data on newly diagnosed cases of malignant melanoma were This study provides a comprehensive analysis of the most obtained from the National Cancer Institute’s SEER program (SEER). recent SEER data covering a large segment of the US Information on mortality from melanoma was obtained from the population. Additional strengths include a more specific National Center for Health Statistics. SEER data are collected by 13 classification of ethnicity of non-Hispanic whites, providing population-based cancer registries including Atlanta, Connecticut, precise estimates of risk of melanoma among those at highest Detroit, Hawaii, Iowa, New Mexico, San Francisco-Oakland, risk. Moreover, calculation of SES-specific incidence trends Seattle-Puget Sound, Utah, Los Angeles and San Jose-Monterey, rural allowed us to examine trends of thicker tumors in a Georgia and the Alaska Native Tumor Registry. The non-Hispanic population with poorer access to screening. Complete SES white population covered by SEER is somewhat more urban but data were available for the state of California; however, this otherwise generally representative of the overall US population. reflected relative SES of the patient’s neighborhood at the Because of the disparate incidence of melanoma in fair-skinned time of diagnosis, and therefore may be misclassified with populations, previous studies on melanoma trends in the United respect to socioeconomic characteristics measured at the States have restricted analyses to individuals of white ethnicity (Hall individual level or for time periods before diagnosis. SES- et al., 1999; Geller et al., 2002). For more accurate assessment, we specific data were not available outside the state of limited our analyses to non-Hispanic whites who account for over California. 90% of melanoma cases in the United States. Because of our Incomplete reporting of certain cancer registry data items, particular interest in melanoma trends according to tumor thickness, including histologic subtype and thickness, may have biased we further restricted our analysis to the time period for which data on the ultimate representativeness of our final study cohort. This these variables were available in the SEER database; from 1992 to issue underscores the dependence of accurate melanoma 2004 (the most recent year available for which Veterans Adminis- surveillance on both the quality and completeness of tration reporting to SEER was complete). We obtained data regarding melanoma reporting to cancer registries by diagnosing all incident cases of invasive cutaneous melanoma (International hospitals and physicians (Hall et al., 2003). Underreporting Classification of Diseases for Oncology topography codes C44.0 (Koh et al., 1992; Zippin et al., 1995; Cockburn et al., 2008, through C44.9) including year at diagnosis, tumor thickness, in press) and delayed reporting (Clegg et al., 2002) of histology, patient age, race, and sex. All patient and tumor melanoma to cancer registries have been documented and information was abstracted and coded directly from the medical indicate that even the best assessments of melanoma record or death certificate by trained cancer registry personnel. incidence patterns likely represent underestimates. Assignment of patient Hispanic race/ethnicity was augmented by We do not believe that improvements in the reporting of Hispanic surname lists. International Classification of Diseases for thickness information over time could fully explain our Oncology-3 classification of histology was used to examine trends observations of increasing incidence trends across all in superficial spreading melanoma (8743), nodular melanoma thickness categories, as demonstrated in our sensitivity (8721), lentigo maligna melanoma (8742), acral lentiginous mela- analyses described above. Furthermore, missing thickness noma (8744), melanoma not otherwise specified (8720) and other was not associated with patient age, sex, or suggesting that histologic types (other; 8723, 8730, 8740, 8745, 8761, 8770–8773, thickness data are largely missing at random. and 8780). Tumor thickness was classified according to 2002 The absolute magnitude of melanoma incidence in older American Joint Committee on Cancer tumor (T) categories as o1, white men warrants greater public health attention, as these 1.01–2, 2.01–4 or 44 mm (Balch et al., 2001a). On average, tumor data suggest a contemporary incidence rate exceeding 125 thickness was not recorded in 15.1% of the SEER melanoma patients. cases per 100,000 men aged 65 and older. This is Patients with missing thickness information did not differ signi- proportional to the incidence of non-Hodgkin’s lymphoma ficantly from patients with known melanoma thickness by age at in the same population, making malignant melanoma the fifth diagnosis or gender, although missing thickness information was most common cancer in older white men following prostate, more common among higher SES groups. The proportion of lung, colorectal, and bladder cancer. If melanoma is truly melanomas with missing thickness information declined over time. increasing in all thickness categories and across socio- We therefore performed sensitivity analyses to assess the impact on economic levels, it will soon become a major concern for our results of improved reporting of thickness over time. an increasingly aging population and their health-care providers. Secondary prevention through early detection of Socioeconomic status index melanoma is especially important in reducing mortality in Three of the SEER member registries, together comprising the high-risk groups (Geller et al., 2006), including those of statewide California Cancer Registry, developed a measure of lowest SES who demonstrated the sharpest rises in thick neighborhood SES based on characteristics of the census tract of melanoma incidence in the California data. Our analysis also patient residence at the time of diagnosis. This small-area measure highlights the need for continued, detailed surveillance of has been used previously to predict cancer and other health melanoma occurrence, which in turn, underscores the outcomes (Yost et al., 2001; Clarke et al., 2005). This index

www.jidonline.org 7 E Linos et al. Melanoma in the United States

incorporates information regarding education, median household melanoma patients: validation of the American Joint Committee on income, proportion living 200% below poverty level, proportion of Cancer melanoma staging system. J Clin Oncol 19:3622–34 blue-collar workers, proportion older than 16 years and unem- Barth A, Wanek LA, Morton DL (1995) Prognostic factors in 1,521 melanoma ployed, median rent and median house value using principal patients with distant metastases. J Am Coll Surg 181:193–201 components analysis as described by Yost et al. (2001). The index Clarke CA, Glaser SL, Keegan TH, Stroup A (2005) Neighborhood socio- ¼ ¼ economic status and Hodgkin’s lymphoma incidence in California. was divided into quintiles (1 lowest, 5 highest). Complete Cancer Epidemiol Biomarkers Prev 14:1441–7 information on census tract SES index was available for all Clegg LX, Feuer EJ, Midthune DN, Fay MP, Hankey BF (2002) Impact of individuals in this analysis. This was assigned randomly within reporting delay and reporting error on cancer incidence rates and trends. county of residence at diagnosis for patients with unknown census J Natl Cancer Inst 94:1537–45 tract of residence. Because census tract-level population denomi- Cockburn M, Swetter SM, Peng D, Keegan TH, Deapen D, Clarke CA (2008) nators are available from the US Census Bureau for decennial census Melanoma underreporting: Why does it happen, how big is the problem, and how do we fix it?. J Arn Acad Dermatol 59:1081–5 years only, we examined SES-specific trends for the 5-year periods Cockburn MG, Zadnick J, Deapen D (2006) Developing epidemic of surrounding decennial census years, (for example, 1988–1992 and melanoma in the Hispanic population of California. Cancer 106:1162–8 1998–2002). de Vries E, Bray FI, Coebergh JW, Parkin DM (2003a) Changing epidemiology of malignant cutaneous melanoma in Europe 1953–1997: rising trends in Statistical analysis incidence and mortality but recent stabilizations in western Europe and decreases in Scandinavia. Int J Cancer 107:119–26 SEER*Stat software (SEER*Stat) was used to calculate annual melanoma incidence and mortality rates for each year between de Vries E, Coebergh JW (2004) Cutaneous malignant melanoma in Europe. Eur J Cancer 40:2355–66 1992 and 2004, reported as cases or deaths per 100,000 people, and de Vries E, Schouten LJ, Visser O, Eggermont AM, Coebergh JW (2003b) age-adjusted to the 2000 US population standard. Standard errors, Rising trends in the incidence of and mortality from cutaneous 95% confidence intervals, and all tests of statistical significance are melanoma in the Netherlands: a Northwest to Southeast gradient? Eur J two-sided, P-value ¼ 0.05. Incidence trends for each classification Cancer 39:1439–46 of tumor thickness were examined using estimated APCs from 1992 Dennis LK (1999) Analysis of the melanoma epidemic, both apparent and to 2004, calculated by fitting a least squares regression line to the real: data from the 1973 through 1994 surveillance, epidemiology, and end results program registry. Arch Dermatol 135:275–80 natural logarithm of the rates, using calendar year as the dependent Diffey B (2004) Climate change, ozone depletion and the impact on variable. Because only two time periods were available for SES- ultraviolet exposure of human skin. Phys Med Biol 49:R1–11 specific trends, we calculated SES-specific incidence rate ratios to Florez A, Cruces M (2004) Melanoma epidemic: true or false? Int J Dermatol comparing period 2 (1998–2002) to period 1 (1988–1992). 43:405–7 Geller AC, Miller DR, Annas GD, Demierre MF, Gilchrest BA, Koh HK (2002) CONFLICT OF INTEREST Melanoma incidence and mortality among US whites, 1969–1999. JAMA The authors state no conflict of interest. 288:1719–20 Geller AC, Miller DR, Swetter SM, Demierre MF, Gilchrest BA (2006) A call for the development and implementation of a targeted national ACKNOWLEDGMENTS melanoma screening program. Arch Dermatol 142:504–7 We acknowledge the helpful statistical input of Sarah J Shema, MS, Northern California Cancer Center in this analysis. Geller AC, Swetter SM, Brooks K, Demierre MF, Yaroch AL (2007) Screening, early detection, and trends for melanoma: current status (2000–2006) Financial Disclosure and future directions. J Am Acad Dermatol 57:555–72 This study was supported by a developmental cancer research award from the Hall HI, Jamison P, Fulton JP, Clutter G, Roffers S, Parrish P (2003) Reporting Stanford Comprehensive Cancer Center. The National Institutes of Health cutaneous melanoma to cancer registries in the United States. J Am Acad grant R25 CA098566 provided salary support for EL. MC was supported in Dermatol 49:624–30 part by NIEHS grant 5P30 ES07048, and National Institutes of Health grant Hall HI, Miller DR, Rogers JD, Bewerse B (1999) Update on the incidence and R01 CA121052. The collection of cancer incidence data used in this study mortality from melanoma in the United States. J Am Acad Dermatol was supported by the California Department of Public Health as part of the 40:35–42 statewide cancer reporting program mandated by California Health and Safety Code Section 103885; the National Cancer Institute’s Surveillance, Epide- Jemal A, Devesa SS, Hartge P, Tucker MA (2001) Recent trends in cutaneous miology and End Results Program under contract N01-PC-35136 awarded to melanoma incidence among whites in the United States. J Natl Cancer the Northern California Cancer Center, contract N01-PC-35139 awarded to Inst 93:678–83 the University of Southern California, and contract N01-PC-54404 awarded Koh D, Wang H, Lee J, Chia KS, Lee HP, Goh CL (2003) Basal cell carcinoma, to the Public Health Institute; and the Centers for Disease Control and squamous cell carcinoma and melanoma of the skin: analysis of the Prevention’s National Program of Cancer Registries, under agreement Singapore Cancer Registry data 1968–97. Br J Dermatol 148:1161–6 1U58DP00807-01 awarded to the Public Health Institute. The ideas and opinions expressed herein are those of the authors and endorsement by the Koh HK, Geller A, Miller DR, Clapp RW, Lew RA (1992) Underreporting of State of California, Department of Public Health the National Cancer Institute, cutaneous melanoma in cancer registries nationwide. J Am Acad and the Centers for Disease Control and Prevention or their Contractors and Dermatol 27:1035–6 Subcontractors is not intended nor should be inferred. Korn EL, Liu PY, Lee SJ, Chapman JA, Niedzwiecki D, Suman VJ et al. (2008) Meta-analysis of phase II cooperative group trials in metastatic stage IV melanoma to determine progression-free and overall survival bench- marks for future phase II trials. J Clin Oncol 26:527–34 REFERENCES Lamberg L (2002) ‘‘Epidemic’’ of malignant melanoma: true increase or better Balch CM, Buzaid AC, Soong SJ, Atkins MB, Cascinelli N, Coit DG et al. detection? JAMA 287:2201 (2001a) Final version of the American Joint Committee on Cancer staging Lasithiotakis KG, Leiter U, Gorkievicz R, Eigentler T, Breuninger H, Metzler G system for cutaneous melanoma. J Clin Oncol 19:3635–48 et al. (2006) The incidence and mortality of cutaneous melanoma in Balch CM, Soong SJ, Gershenwald JE, Thompson JF, Reintgen DS, Southern Germany: trends by anatomic site and pathologic character- Cascinelli N et al. (2001b) Prognostic factors analysis of 17,600 istics, 1976 to 2003. Cancer 107:1331–9

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Lipsker D, Engel F, Cribier B, Velten M, Hedelin G (2007) Trends in Smith RA, Cokkinides V, Eyre HJ (2007) Cancer screening in the United melanoma epidemiology suggest three different types of melanoma. States, 2007: a review of current guidelines, practices, and prospects. Br J Dermatol 157:338–43 CA Cancer J Clin 57:90–104 Mansson-Brahme E, Johansson H, Larsson O, Rutqvist LE, Ringborg U Stang A, Pukkala E, Sankila R, Soderman B, Hakulinen T (2006) Time trend (2002) Trends in incidence of cutaneous malignant melanoma in a analysis of the skin melanoma incidence of Finland from 1953 through Swedish population 1976–1994. Acta Oncol 41:138–46 2003 including 16,414 cases. Int J Cancer 119:380–4 Ortiz CA, Goodwin JS, Freeman JL (2005) The effect of socioeconomic factors Surveillance, Epidemiology, and End Results (SEER) Program ( www.seer. on incidence, stage at diagnosis and survival of cutaneous melanoma. cancer.gov ) SEER*Stat Database: Mortality – All COD, Public-Use With Med Sci Monit 11:RA163–72 State, Total U.S. (1990–2004), National Cancer Institute, DCCPS, Pollitt RA, Clarke CA, Shema SJ, Swetter SM (2008) California Medicaid Surveillance Research Program, Cancer Statistics Branch, released April enrollment and melanoma stage at diagnosis: a population-based study. 2007. Underlying mortality data provided by NCHS ( www.cdc.gov/nchs) Am J Prev Med 35:7–13 Swerlick RA, Chen S (1996) The melanoma epidemic. Is increased Ries L, Eisner M, Kosary C (2002) SEER Cancer Statistics Review, 1975–2002. surveillance the solution or the problem? Arch Dermatol 132:881–4 Bethesda, MD: National Cancer Institute Swerlick RA, Chen S (1997) The melanoma epidemic: more apparent than Roetzheim RG, Pal N, Tennant C, Voti L, Ayanian JZ, Schwabe A et al. (1999) real? Mayo Clin Proc 72:559–64 Effects of health insurance and race on early detection of cancer. J Natl Ulmer MJ, Tonita JM, Hull PR (2003) Trends in invasive cutaneous melanoma Cancer Inst 91:1409–15 in Saskatchewan 1970–1999. J Cutan Med Surg 7:433–42 Saraiya M, Hall HI, Thompson T, Hartman A, Glanz K, Rimer B et al. (2004) Weissman JS, Schneider EC (2005) Social disparities in cancer: lessons from Skin cancer screening among U.S. adults from 1992, 1998, and 2000 a multidisciplinary workshop. Cancer Causes Control 16:71–4 National Health Interview Surveys. Prev Med 39:308–14 Welch HG, Woloshin S, Schwartz LM (2005) Skin biopsy rates and incidence SEER. http://seer.cancer.gov/registries/characteristics.html of melanoma: population based ecological study. BMJ 331:481 SEER*Stat software, version 6.1.4 Bethesda MD: Surveillance Research Yost K, Perkins C, Cohen R, Morris C, Wright W (2001) Socioeconomic status Program, National Cancer institute 2005 and breast cancer incidence in California for different race/ethnic Singh G, Miller B, Hankey B, Edwards B (2003) Area Socioeconomic groups. Cancer Causes Control 12:703–11 Variations in U.S. Cancer Incidence, Mortality, Stage, Treatment and Zippin C, Lum D, Hankey B (1995) Completeness of hospital cancer case Survival, 1975–1999: 1–129. NCI Cancer Surveillance Monograph reporting from the SEER Program of the National Cancer Institute. Cancer Series 4 76:2343–5

www.jidonline.org 9 Report on Carcinogens, Twelfth Edition (201) Table of Contents: http://ntp.niehs.nih.gov/go/roc12

Ultraviolet-Radiation-Related Exposures Carcinogenicity Exposure to sunlamps or sunbeds is known to be a human carcino- Introduction gen based on sufficient evidence of carcinogenicity from studies in Ultraviolet radiation (UVR) is electromagnetic radiation found be- humans. Sunlamps and sunbeds emit primarily UVA and UVB radia- tween X-radiation and light in the electromagnetic spectrum. It is tion. Epidemiological studies have shown that exposure to sunlamps emitted by the sun and artificial devices, including sunbeds or sun- or sunbeds increases the risk of malignant melanoma (Swerdlow et lamps. UVR can be divided into ultraviolet A (UVA), ultraviolet B al. 1988, Walter et al. 1990, 1999, Autier et al. 1994, Westerdahl et al. (UVB), and ultraviolet C (UVC) radiation components. 1994, 2000, Chen et al. 1998). The longer the exposure, the greater the Solar radiation and exposure to sunlamps or sunbeds were first risk, especially in individuals exposed before the age of 30 and indi- listed in the Ninth Report on Carcinogens in 2000, and broad-spec- viduals who have been sunburned. Malignant melanoma of the eye trum UVR and its components (UVA, UVB, and UVC) were first also is associated with exposure to sunlamps (IARC 1992). listed in the Tenth Report on Carcinogens in 2002. Exposure to solar radiation and to sunlamps or sunbeds involves exposure to broad- Broad-Spectrum UVR spectrum UVR; therefore, these listings were combined for the Tenth Report on Carcinogens. The listings for exposures related to UVR are CAS No.: none assigned as follows: Known to be a human carcinogen • Solar radiation is known to be a human carcinogen. First listed in the Tenth Report on Carcinogens (2002) • Exposure to sunlamps or sunbeds is known to be a human carcinogen. Carcinogenicity • Broad-spectrum UVR is known to be a human carcinogen. Broad-spectrum UVR is known to be a human carcinogen based on • Ultraviolet A radiation is reasonably anticipated to be a sufficient evidence of carcinogenicity from studies in humans. Evi- human carcinogen. dence that the broad-spectrum UVR component of solar radiation • Ultraviolet B radiation is reasonably anticipated to be a is carcinogenic comes from (1) studies of human cancer associated human carcinogen. with exposure to devices that emit artificial broad-spectrum UVR, • Ultraviolet C radiation is reasonably anticipated to be a (2) the fact that tumors develop at the same tissue sites in humans human carcinogen. exposed to sunlight and in animals exposed to broad-spectrum UVR Much of the evidence for listing of the various UVR-related expo- from artificial sources, and (3) mechanistic studies in which human sures applies to more than one type of UVR. For example, evidence tissue was exposed to artificial sources of broad-spectrum UVR (see for the carcinogenicity of broad-spectrum UVR comes from studies Studies on Mechanisms of Carcinogenesis, below). on solar radiation and on exposure to sunlamps or sunbeds. Similarly, studies that evaluated the carcinogenicity of solar radiation in exper- Cancer Studies in Humans imental animals or the mechanism(s) by which sunlight causes can- Epidemiological studies have shown that exposure to broad-spectrum cer (mechanistic studies) involved exposure to broad-spectrum UVR UVR from solar radiation causes skin cancer (malignant melanoma or its UVA, UVB, or UVC components. Most of the information on and non-melanocytic cancer) (IARC 1992). Studies of humans ex- mechanisms of carcinogenesis and on properties, use, production, posed to solar radiation, artificial devices emitting broad-spectrum exposure, and regulations is common to all listings for exposures re- UVR, or devices emitting predominantly UVA or UVB all contrib- lated to UVR. Therefore, the carcinogenicity section for each of these ute to these conclusions. listings is presented separately, and the other sections are combined. Cancer Studies in Experimental Animals Solar Radiation Exposure of albino rats and mice to broad-spectrum UVR caused benign and malignant skin tumors (papilloma, squamous-cell carci- CAS No.: none assigned noma, and spindle-cell sarcoma). Exposure to broad-spectrum UVR Known to be a human carcinogen also caused malignant eye tumors in albino rats (spindle-cell sarcoma) and in hamsters (fibrosarcoma) (IARC 1992). First listed in the Ninth Report on Carcinogens (2000) Carcinogenicity UVA Solar radiation is known to be a human carcinogen based on sufficient CAS No.: none assigned evidence of carcinogenicity from studies in humans, which indicate that exposure to solar radiation causes skin cancer (malignant mel- Reasonably anticipated to be a human carcinogen anoma and non-melanocytic cancer). Some studies suggest that so- First listed in the Tenth Report on Carcinogens (2002) lar radiation may also be associated with melanoma of the eye and non-Hodgkin’s lymphoma (IARC 1992). Carcinogenicity UVA is reasonably anticipated to be a human carcinogen based on Exposure to Sunlamps or Sunbeds (1) limited evidence of carcinogenicity from studies in humans and (2) sufficient evidence of carcinogenicity from studies in experimen- CAS No.: none assigned tal animals. Known to be a human carcinogen Cancer Studies in Humans First listed in the Ninth Report on Carcinogens (2000) Epidemiological studies on the effects of sunlight or artificial broad- spectrum UVR cannot identify effects due specifically to UVA, UVB,

Page 429 National Toxicology Program, Department of Health and Human Services Report on Carcinogens, Twelfth Edition (201) or UVC exposure. However, information about the specific effects of in solar radiation causes DNA damage (see Studies on Mechanisms UVA, UVB, and UVC exposure can be inferred by comparing the re- of Carcinogenesis, below). sults of human epidemiology studies on the effects of specific UVR components in experimental animals and human tissues. In studies Cancer Studies in Experimental Animals where most of the UVR exposure was to UVA (i.e., exposure to solar Exposure to high doses of radiation from devices emitting primar- radiation or UVA-emitting sunbeds), exposure increased the risk of ily UVC caused skin cancer in rats (keratoacanthoma-like tumors) skin cancer. Exposure to sunbeds emitting mainly UVA (with 0.1% to and mice (squamous-cell carcinoma and fibrosarcoma) (IARC 1992). 2.1% UVB) increased the risk of melanoma (Westerdahl et al. 2000). Cancer Studies in Humans Cancer Studies in Experimental Animals No epidemiological studies have adequately evaluated the carcino- Exposure to UVA caused benign and malignant skin tumors (papil- genicity of UVC in humans. UVC is absorbed by the ozone layer and loma and squamous-cell carcinoma) in mice (IARC 1992) and mel- does not contribute to UVR exposure from solar radiation. In stud- anoma in fish (Setlow et al. 1993). ies of exposure to artificial devices emitting UVC, the devices also emitted other components of UVR. UVB Ultraviolet-Radiation-Related Exposures CAS No.: none assigned Reasonably anticipated to be a human carcinogen Studies on Mechanisms of Carcinogenesis First listed in the Tenth Report on Carcinogens (2002) Broad-spectrum UVR causes skin cancer via DNA damage, suppression of the immune system, tumor promotion, and mutations in the Carcinogenicity p53 tumor-suppressor gene. Broad-spectrum UVR causes mutations UVB is reasonably anticipated to be a human carcinogen based on in cultured human cells; the type of damage depends on the specific (1) limited evidence of carcinogenicity from studies in humans and wavelength of UVR and whether the affected cells can repair the dam- (2) sufficient evidence of carcinogenicity from studies in experimen- age without error. DNA absorbs broad-spectrum UVR (mainly UVB tal animals. In addition, mechanistic studies with human tissue have and UVC), and this reaction yields products that can cause mutations demonstrated that the UVB component in solar radiation causes (discussed below, under Properties). UVB causes the following four DNA damage (see Studies on Mechanisms of Carcinogenesis, below). major DNA base modifications in humans: cyclobutane-type pyrimidine dimers, (6-4) photoproducts, the corresponding Dewar isomers, Cancer Studies in Humans and thymine glycols. Both UVA and UVB induce 8-hydroxydeoxy- Epidemiological studies linking UVR exposure to skin cancer are lim- guanosine production from guanosine by the action of singlet oxy- ited because they lack information on the specific wavelengths of UVR gen (Griffiths et al. 1998). to which the individuals were exposed. Increased risk of skin cancer is UVA, UVB, and UVC as individual components of broad- clearly associated with exposure to UVB (as a component of solar ra- spectrum UVR have been shown to cause genetic damage in several diation or from sunlamps used before the early 1970s). However, the in vitro test systems, including bacteria, yeast, rodent cells, and hu- individuals in these studies were also exposed to other components man cells. Moreover, exposure to each of the three components of of broad-spectrum UVR; therefore, the studies could not distinguish broad-spectrum UVR causes DNA damage in humans. UVA’s bio- between the effects of UVB and other components of UVR. Sunlamps logical effects are indirect and largely the result of energy transferred used in the early 1970s produced significant amounts of UVB (22% to through reactive oxygen intermediates, whereas UVB and UVC are 40%); one study found that exposure to UVB-emitting sunlamps in- absorbed by DNA and directly damage DNA through base modifi- creased the risk of malignant melanoma of the skin (Chen et al. 1998). cations. Based on the numbers of studies showing genetic damage, UVC is the strongest genotoxin of the three components of broad- Cancer Studies in Experimental Animals spectrum UVR, and UVA is the weakest. Prolonged exposure to devices emitting primarily UVB caused benign More than 90% of human squamous-cell carcinomas contain and/or malignant skin tumors in rats (papilloma), mice (papilloma, mutations of the p53 tumor suppressor gene. These mutations were squamous-cell carcinoma, fibrosarcoma, and keratoacanthoma), found in 74% of sun-exposed normal human skin samples and only guinea pigs (fibroma and trichofolliculoma), and opossums (mela- 5% of unexposed skin samples, indicating a strong association with nocytic hyperplasia and melanoma) (IARC 1992). sun exposure. Observed p53 gene mutations were most frequently C to T or C:C to T:T transitions at pyrimidine–pyrimidine sequences. UVC These specificp53 mutations now are considered a signature of broad- spectrum UVR carcinogenesis (Brash et al. 1991, Ziegler et al. 1993, CAS No.: none assigned Griffiths et al. 1998, Wikonkal and Brash 1999). Reasonably anticipated to be a human carcinogen Exposure to solar radiation and broad-spectrum UVR alters immune function in humans and experimental animals (IARC 1992). First listed in the Tenth Report on Carcinogens (2002) Evidence that immunosuppression is related to skin cancer comes from the following observations: (1) immunosuppressed organ trans- Carcinogenicity plant recipients showed a marked increase in skin cancer, particu- UVC is reasonably anticipated to be a human carcinogen based on larly squamous-cell carcinoma, (2) broad-spectrum UVR decreased (1) limited evidence of carcinogenicity from studies on mechanisms the ability to mount a delayed-type hypersensitivity response, and of carcinogenesis in human tissue and (2) sufficient evidence of car- (3) mice exposed to low levels of broad-spectrum UVR failed to re- cinogenicity from studies in experimental animals. Mechanistic stud- ject highly immunogenic tumor cell lines (Quinn 1997). ies with human tissue have demonstrated that the UVC component

National Toxicology Program, Department of Health and Human Services Report on Carcinogens, Twelfth Edition (201)

Exposure of human skin grafts on mice to UVB radiation caused healthy bones. Brief exposure to sunlight on a regular basis is suf- precancerous lesions (melanocytic hyperplasia), and exposure to ficient to produce all of the vitamin D most people need. This vita- UVB after pretreatment with the carcinogen dimethylbenz[a]anthra- min can also be obtained from dietary sources. Artificial sources of cene caused the grafts to develop human skin tumors (squamous-cell broad-spectrum UVR have many uses, including tanning, medical carcinoma, actinic keratoses, melanocytic hyperplasia, and mela- diagnosis and treatment, and promotion of polymerization reactions noma) (Atillasoy et al. 1997). (e.g., curing of protective coatings). Sunbeds use artificially produced UVR to enable individuals to develop a suntan for cosmetic reasons. Properties Originally, sunbeds were built with mercury arc lamps, which emit- Solar radiation includes most of the electromagnetic spectrum. Of ted large quantities of UVB and UVC. Now, sunbeds and solaria emit the bands within the optical radiation spectrum, UVR is the stron- mostly UVA (IARC 1992). gest and most damaging to living things (IARC 1992). Broad-spec- Broad-spectrum UVR has both diagnostic and therapeutic uses in trum UVR includes wavelengths of light ranging from 100 to 400 nm. medicine and dentistry. More than 30 disorders now can be treated UVR is divided into wavelength ranges identified as UVA (315 to through UVA exposure combined with compounds called psoralens 400 nm), UVB (280 to 315 nm), and UVC (100 to 280 nm). Of the (PUVA therapy). Psoriasis and eczema are the skin diseases most fre- solar UV energy reaching the equator, 95% is UVA and 5% is UVB. quently treated with PUVA therapy. PUVA can also be used with UVB No measurable UVC from solar radiation reaches the earth’s surface, exposure to treat psoriasis patients who are not good candidates for because the shortest UV wavelengths are completely absorbed by systemic therapy with methotrexate or etretinate (Morrison 1992). ozone, molecular oxygen, and water vapor in the upper atmosphere In addition, broad-spectrum UVR and, more commonly, UVB are (Farmer and Naylor 1996). used with coal-tar creams to treat psoriasis (Reid 1996). UVB also Molecules that absorb UVR and visible light (photoreactive mol- may be used to convert 7-dehydrocholesterol (provitamin D) to vi- ecules) contain segments that react with light (called chromophores), tamin D in the skin of vitamin D-deficient patients. in which photons of light excite electrons from the ground state to UVA may be a component of the phototherapy used to treat neo- higher-energy states. These molecules then generally re-emit light natal jaundice or hyperbilirubinemia. Typically, an infant is irradiated on returning to lower-energy or ground states (Dyer 1965). The var- with visible light for several hours a day, for up to one week. However, ious molecules sensitive to UVR differ in the wavelengths of UVR the lamps also may emit UVR, and one commercial neonatal photo- that they absorb and the light that they emit. Photochemical and therapy unit was found to emit UVA and shorter wavelengths of UVR photobiological interactions occur when photons react with a pho- (IARC 1992). UVA has been found to react with melatonin, a hor- toreactive molecule, forming either an altered molecule or two sep- mone that helps to regulate sleep-wake cycles. Although the photo- arate molecules (Phillips 1983, Smith 1989). For such a reaction to products of melatonin have not been identified, melatonin has been occur, the photons must have enough energy to alter a photoreactive predicted to be moderately phototoxic (Kim et al. 1999). chemical bond (i.e., to break the original bond or form new bonds). Broad-spectrum UVR has many industrial applications. One of The photobiological reactions related to skin cancer risk due to its major industrial uses is in photopolymerization, including curing UVR exposure are the reactions with the main chromophores of the of protective coatings and inks. Broad-spectrum UVR is used to sim- skin’s outer layer — urocanic acid, DNA, tryptophan, tyrosine, and ulate weathering of various materials, such as polymers. UVR (usu- the melanins. The products resulting from the reaction of UVR with ally UVC at 260 to 265 nm) is used to sterilize and disinfect tools DNA (DNA photoproducts) include pyrimidine dimers, pyrimidine- and materials. UVR is also used in UV photography, UV lasers, and pyrimidone (6-4) photoproducts, thymine glycols, and DNA exhib- dental examinations to detect early dental caries, dental plaque, and iting cytosine and purine damage and other damage, such as DNA calculus (IARC 1992). strand breaks and cross-links and DNA-protein cross-links. The various DNA photoproducts differ in their mutagenic potential (IARC Sources 1992). UVR-induced DNA photoproducts cause a variety of cellu- In the broadest sense, broad-spectrum UVR is formed when some- lar responses that contribute to skin cancer. Unrepaired DNA pho- thing is heated or when electrons that have been raised to an excited toproducts may result in the release of cyto kines that contribute to state return to a lower energy level. Broad-spectrum UVR is naturally tumor promotion, tumor progression, immunosuppression, and the emitted by the sun. An estimated two thirds of the energy emitted induction of latent viruses (IARC 1992, Yarosh and Kripke 1996). by the sun penetrates the atmosphere. Broad-spectrum UVR consti- UVB is considered to be the major cause of skin cancer, despite tutes approximately 5% of the solar radiation that reaches the earth’s the fact that it does not penetrate the skin as deeply as UVA or re- surface (IARC 1992). act with the outer skin layer as vigorously as UVC. Its high reactivity Six artificial sources of broad-spectrum UVR have been identi- with macromolecules, coupled with the depth to which it penetrates fied: incandescent lights, gas-discharge lamps, arc lamps, fluorescent skin, makes UVB the most potent portion of the UV spectrum for lamps, metal halide lamps, and electrodeless lamps. Incandescent both short-term and long-term biological effects. UVA, while pos- sources provide visible radiation in a continuous spectrum. Gas- sibly not as dangerous, also causes biological damage (Farmer and discharge lamps produce visible radiation when an electrical current Naylor 1996). is passed through a gas. The type of gas present in the lamp determines the emission wavelengths; low gas pressures produce narrow Use bands, whereas higher pressures produce broad bands. Arc lamps are Broad-spectrum UVR has many uses as a natural source of energy intense sources of broad-spectrum UVR and often are used to sim- and is important in various biological processes. Solar radiation is ulate solar radiation. Fluorescent lamps emit radiation from a low- required for life. Plants must have sunlight to grow and to produce pressure mercury discharge, which produces a strong emission at carbohydrates and oxygen. Broad-spectrum UVR from solar radia- 254 nm; this radiation excites the phosphor-coated lamp to produce tion helps produce vitamin D in human skin cells. Vitamin D me- fluorescence. Various emission spectra can be obtained by altering tabolites promote the absorption of calcium by the intestinal tract; the makeup and thickness of the phosphor and the glass envelope. therefore, vitamin D is essential for the growth and development of In metal halide lamps, metal halide salts are added to a mercury-

National Toxicology Program, Department of Health and Human Services Report on Carcinogens, Twelfth Edition (201) vapor discharge lamp, thus creating extra emission lines. Electrode- tanner. About 25 million people in the United States use sunbeds each less lamps use magnetrons to generate microwave energy, which then year, and 1 million to 2 million people visit tanning facilities as often is absorbed by the discharge tube (IARC 1992). as 100 times per year (Sikes 1998, Swerdlow and Weinstock 1998). Low-pressure mercury-vapor lamps, sunlamps, and black-light Teenagers and young adults are prominent among users. A 1995 U.S. lamps are considered to be low-intensity UVR sources. High-intensity survey found that of commercial tanning salon patrons, 8% were 16 UVR sources include high-pressure mercury-vapor lamps, high-pres- to 19 years old, 42% were 20 to 29 years old, and 71% were female sure xenon arc lamps, xenon-mercury arc lamps, plasma torches, and (Swerdlow and Weinstock 1998). welding arcs. Anyone working outside (such as agricultural, construction, or Sunlamps and sunbeds emit broad-spectrum UVR. Sunbeds now road-work laborers) is occupationally exposed to solar radiation. For chiefly emit UVA; however, before the mid 1970s, they more com- a group of more than 800 outdoor workers in the United States at monly emitted UVB and UVC (IARC 1992). Three different UVA 39° N latitude (the latitude of Philadelphia, Pennsylvania), personal phosphors have been used in sunlamps sold in the United States annual exposure of the face was estimated at 30 to 200 MED (Rosen- since the late 1970s, producing emission spectra that peak at 340, 350, thal et al. 1991). However, this estimate may be low, because facial or 366 nm. Two modern sunlamps evaluated by the U.S. Food and exposure was assumed to be only 5% to 10% of ambient exposure, Drug Administration emitted 99.0% and 95.7% UVA; the remaining whereas other data suggest that it could be as high as 20%. Based on radiation was UVB. A new high-pressure UVA sunbed with eighteen this higher estimate, the annual facial exposure doses for these out- 1,600-watt filtered arc lamps emitted 99.9% UVA. An older type of door workers would be 80 to 500 MED (IARC 1992). sunlamp, used prior to the late 1970s (UVB/FS type), emitted 48.7% Occupational exposure to artificial broad-spectrum UVR occurs UVA (Miller et al. 1998). in industrial photo processes, principally UV curing of polymer inks, coatings, and circuit board photoresists; sterilization and disinfection; Exposure quality assurance in the food industry; medical and dental practices; The greatest source of human exposure to broad-spectrum UVR is and welding (IARC 1992). UV lasers, such as those used in cornea solar radiation; however, the exposure varies with geographical lo- shaping and coronary angioplasty, are another potential source of cation. Information on global broad-spectrum UVR levels has been occupational exposure, with relative risks that could be compara- compiled from data gathered for epidemiological studies of skin can- ble to risks for individuals in outdoor professions (Sterenborg et al. cer and other health effects, such as premature aging of the skin, cata- 1991). Electric arc welders are the largest occupational group with racts, and suppression of the immune response. Despite the large exposure to artificial broad-spectrum UVR. It is estimated that more number of measurements, estimating human exposure is complex. than 500,000 welders in the United States have been occupationally The UVR wavelengths to which an individual is exposed vary con- exposed to broad-spectrum UVR. Occupational exposure to artifi- siderably with latitude, altitude, time of day, and season. People also cial broad-spectrum UVR depends on both the source of exposure vary in their length of outdoor exposure, the parts of the body they and the protective methods used to decrease exposure. Some ar- expose, and the shapes of their bodies. Nevertheless, many studies tificial broad-spectrum UVR sources (such as germicidal lamps in have estimated exposure to broad-spectrum UVR. Few studies, how- some uses) are self-contained and present no risk to workers. Other ever, were able to distinguish between UVA, UVB, and UVC expo- occupational uses, such as use of UVR in laboratories, UV photog- sure (IARC 1992). raphy, and UV lasers, inevitably lead to broad-spectrum UVR expo- Various factors influence terrestrial levels of UVA (i.e., levels found sure, which may include intense short-term exposures (IARC 1992). at the earth’s surface). UVA levels decrease with increasing distance from the equator and increase with increasing altitude. Terrestrial Regulations UVA levels are also decreased by stratospheric ozone, which varies Environmental Protection Agency (EPA) with latitude and season. When there is less ozone, more UVA reaches Clean Air Act the earth’s surface. Time of day also influences UVA levels. Clouds EPA has developed a suite of regulations to protect stratospheric ozone, guarding against increased reduce the amount of UVA reaching ground level. Air pollution, in- UVR exposures resulting from its loss. cluding tropospheric ozone, can decrease UVA exposure, especially Food and Drug Administration (FDA) in urban areas. Surface reflection also contributes to personal expo- Performance standards for sunlamps and other devices that emit UVR have been developed. sures to UVA and can result in exposure to body parts that other- User instructions and warning labels must accompany sunlamps and other devices that emit UVR. wise would be shaded from the sun (IARC 1992). Specifications for the use of UVR for processing and treating food have been developed. A warning must be included with products containing coal tar for the control of psoriasis that reads Terrestrial UVB levels are affected by the same factors as terres- “Do not use this product with other forms of psoriasis therapy such as ultraviolet radiation or trial UVA levels. However, since UVB is absorbed more by strato- prescription drugs unless directed to do so by a doctor.” spheric ozone than is UVA, differences in latitude and altitude affect Occupational Safety and Health Administration (OSHA) UVB exposure more than UVA exposure. Seasonal changes affect Regulations have been enacted to protect welders and other workers from UVR exposure during UVB levels, mostly in temperate regions. Generally, cloud cover scat- welding operations. ters less than 10% of the UVB under a clear sky; however, very heavy cloud cover virtually eliminates UVB, even in the summer. Surface Guidelines reflection also contributes to human UVB exposure (IARC 1992). American Conference of Governmental Industrial Hygienists (ACGIH) Commonly used fluorescent sunlamps deliver 0.3 to 1.2 times the Threshold limit values (TLVs) have been developed for 56 different wavelengths (ranging from 180 annual UVA dose from the sun to a typical tanner exposed for 20 ses- to 400 nm) in the UV spectrum. In addition to these TLVs, specific protections for the eye from sions at 2 minimal erythemal doses (MED) per session (Miller et al. exposure to UVR in the 315- to 400-nm spectral range have been developed. 1998). (The MED is the lowest UVR exposure sufficient to produce National Institute for Occupational Safety and Health (NIOSH) well-defined reddening of the skin within 24 hours of exposure.) A NIOSH has established technical guidance for using ultraviolet germicidal irradiation (UVGI) systems to frequent tanner (100 sessions at 4 MED per session) receives 1.2 to help protect health-care workers who may have an occupational risk of tuberculosis infection. It has been recommended that employers reduce worker exposure to UVR through work scheduling, 4.7 times the annual solar UVA dose, while the newer high-pressure providing shade, and providing information on UVR exposure risks. sunlamps deliver 12 times the annual solar UVA dose to the frequent

National Toxicology Program, Department of Health and Human Services Report on Carcinogens, Twelfth Edition (201)

References Atillasoy ES, Elenitsas R, Sauter ER, Soballe PW, Herlyn M. 1997. UVB induction of epithelial tumors in human skin using a RAG-1 mouse xenograft model. J Invest Dermatol 109(6): 704-709. Autier P, Dore JF, Lejeune F, Koelmel KF, Geffeler O, Hille P, et al. 1994. Cutaneous malignant melanoma and exposure to sunlamps or sunbeds: an EORTC multicenter case-control study in Belgium, France and Germany. EORTC Melanoma Cooperative Group. Int J Cancer 58(6): 809-813. Brash DE, Rudolph JA, Simon JA, Lin A, McKenna GJ, Baden HP, Halperin AJ, Ponten J. 1991. A role for sunlight in skin cancer: UV-induced p53 mutations in squamous cell carcinoma. Proc Natl Acad Sci U S A 88(22): 10124-10128. Chen YT, Dubrow R, Zheng T, Barnhill RL, Fine J, Berwick M. 1998. Sunlamp use and the risk of cutaneous malignant melanoma: a population-based case-control study in Connecticut, USA. Int J Epidemiol 27(5): 758-765. Dyer JR. 1965. Introduction. In Applications of Absorption Spectroscopy of Organic Compounds. Englewood Cliffs, NJ: Prentice-Hall. pp. 3-21. Farmer KC, Naylor MF. 1996. Sun exposure, sunscreens, and skin cancer prevention: a year-round concern. Ann Pharmacother 30(6): 662-673. Griffiths HR, Mistry P, Herbert KE, Lunec J. 1998. Molecular and cellular effects of ultraviolet light-induced genotoxicity. Crit Rev Clin Lab Sci 35(3): 189-237. IARC. 1992. Solar and Ultraviolet Radiation. IARC Monographs on the Evaluation of Carcinogenic Risk of Chemicals to Humans, vol. 55. Lyon, France: International Agency for Research on Cancer. 316 pp. Kim YO, Chung HJ, Chung ST, Kim JH, Park JH, Kil KS, Cho DH. 1999. Phototoxicity of melatonin. Arch Pharm Res 22(2): 143-150. Miller SA, Hamilton SL, Wester UG, Cyr WH. 1998. An analysis of UVA emissions from sunlamps and the potential importance for melanoma. Photochem Photobiol 68(1): 63-70. Morrison WL. 1992. Phototherapy and photochemotherapy. Adv Dermatol 7: 255-270. Phillips R. 1983. Sources and Applications of Ultraviolet Radiation. London: Academic Press. 434 pp. Quinn AG. 1997. Ultraviolet radiation and skin carcinogenesis. Br J Hosp Med 58(6): 261-264. Reid CD. 1996. Chemical photosensitivity: another reason to be careful in the sun. FDA Consumer 30(4). http://permanent.access.gpo.gov/lps1609/www.fda.gov/fdac/features/496_sun.html. Rosenthal FS, West SK, Munoz B, Emmett EA, Strickland PT, Taylor HR. 1991. Ocular and facial skin exposure to ultraviolet radiation in sunlight: a personal exposure model with application to a worker population. Health Phys 61(1): 77-86. Setlow RB, Grist E, Thompson K, Woodhead AD. 1993. Wavelengths effective in induction of malignant melanoma. Proc Natl Acad Sci U S A 90: 6666-6670. Sikes RG. 1998. The history of suntanning: a love/hate affair.J Aesthetic Sci 1(2): 6-7. Smith KC, ed. 1989. The Science of Photobiology, 2nd ed. New York: Plenum. pp. 47-53. Sterenborg HJ, de Gruijl FR, Kelfkens G, van der Leun JC. 1991. Evaluation of skin cancer risk resulting from long term occupational exposure to radiation from ultraviolet lasers in the range from 190 to 400 nm. Photochem Photobiol 54(5): 775-780. Swerdlow AJ, English JS, MacKie RM, O’Doherty CJ, Hunter JA, Clark J, Hole DJ. 1988. Fluorescent lights, ultraviolet lamps, and risk of cutaneous melanoma. Br Med J 297(6649): 647-650. Swerdlow AJ, Weinstock MA. 1998. Do tanning lamps cause melanoma? An epidemiologic assessment. J Am Acad Dermatol 38(1): 89-98. Walter SD, Marrett LD, From L, Hertzman C, Shannon HS, Roy P. 1990. The association of cutaneous malignant melanoma with the use of sunbeds and sunlamps. Am J Epidemiol 131(2): 232-243. Walter SD, King WD, Marrett LD. 1999. Association of cutaneous malignant melanoma with intermittent exposure to ultraviolet radiation: results of a case-control study in Ontario, Canada. Int J Epidemiol 28(3): 418-427. Westerdahl J, Olsson H, Masback A, Ingvar C, Jonsson N, Brandt L, Jonsson PE, Moller T. 1994. Use of sunbeds or sunlamps and malignant melanoma in southern Sweden. Am J Epidemiol 140(8): 691-699. Westerdahl J, Ingvar C, Masback A, Jonsson N, Olsson H. 2000. Risk of cutaneous malignant melanoma in relation to use of sunbeds: further evidence for UV-A carcinogenicity. Br J Cancer 82(9): 1593-1599. Wikonkal NM, Brash DE. 1999. Ultraviolet radiation induced signature mutations in photocarcinogenesis. J Investig Dermatol Symp Proc 4(1): 6-10. Yarosh DB, Kripke ML. 1996. DNA repair and cytokines in antimutagenesis and anticarcinogenesis. Mutat Res 350(1): 255-260. Ziegler A, Leffell DJ, Kunala S, Sharma HW, Gailani M, Simon JA, et al. 1993. Mutation hotspots due to sunlight in the p53 gene of nonmelanoma skin cancers. Proc Natl Acad Sci U S A 90(9): 4216-4220.

National Toxicology Program, Department of Health and Human Services

Position Statement on Indoor Tanning (Approved by the Board of Directors October 1998; Amended by the Board of Directors February 7, 2004; Amended by the Board of Directors November 14, 2009; Amended by the Board of Directors August 18, 2012)

The American Academy of Dermatology Association (AADA) opposes indoor tanning and supports prohibiting the sale and use of commercial indoor tanning equipment. The United States Department of Health and Human Services and the World Health Organization classify ultraviolet (UV) radiation from indoor tanning devices as carcinogenic to humans. Use of indoor tanning devices represents a significant and avoidable risk factor for the development of both melanoma and non-melanoma skin cancers. Other adverse effects due to indoor tanning include burns, premature aging of the skin, infection, and exacerbation of certain serious light sensitive conditions including lupus. In addition the Federal Trade Commission has sanctioned the Indoor Tanning Association for making false and misleading health claims.

With the rising incidence of melanoma and non-melanoma skin cancer in the United States, as well as increasing usage of tanning salons for cosmetic purposes by the public, the AADA encourages implementation of federal, state and local legislation regulating tanning salons. Further, the AADA encourages appropriate funding of the regulatory agencies responsible for enforcement of those regulations. Additionally, the AADA urges the Food and Drug Administration (FDA) to take action that will prohibit the sale and use of commercial tanning equipment, and at a minimum reclassify tanning devices to more appropriately designate the health hazards associated with their use. We encourage education of the public on the dangers of indoor tanning by educational entities, government, industry, public health and medical professionals.

Unless and until the FDA takes action to prohibit the sale and use of tanning equipment for non-medical purposes, the AADA supports the following requirements for indoor tanning facilities:

1. No minor, under 18 years old, should be permitted to use tanning devices. 2. A Surgeon General’s warning should be placed on all tanning devices. 3. The warning label required of manufacturers for all tanning devices should read, “Ultraviolet radiation is a known human carcinogen and can cause melanoma and non-melanoma skin cancers and lead to other nonreversible forms of damage to the skin.” The AADA encourages the FDA to amend the warning label requirements for sunlamp products to include specific formatting and placement requirements to more clearly and effectively convey the risks that Indoor Tanning Page 2 of 2

these devices pose for the development of irreversible damage to the eyes and skin, including skin cancer. 4. A warning sign listing known hazards, including the development of melanoma and non-melanoma skin cancer, of tanning device use, including information regarding the FDA’s recommended limits of weekly and yearly exposure dose and the FDA’s recommended limit on the frequency of usage, should be conspicuously posted next to each tanning device. The warning sign shall have dimensions not less than 11 inches by 17 inches and lettering must be clear, legible and at least 0.25 inches high. 5. A warning statement defining the known hazards and consequences of exposure to Ultraviolet A and Ultraviolet B radiation (UVA and UVB), should be signed by each patron. 6. All tanning devices should be inspected regularly for defects by a local or state agency; written reports should be kept for each inspection. 7. Tanning device operators should receive comprehensive training to correctly operate the tanning facility and tanning devices, recognize injury or overexposure to ultraviolet radiation, determine skin type of patrons, and implement emergency procedures in case of injury. 8. Tanning device operators should be required to provide sanitary, protective eyewear to each patron for use during tanning. Tanning device operators should be required to thoroughly sanitize the equipment after every use. 9. Tanning device operators should limit exposure time to the exposure time recommended by the device manufacturer on the tanning device or in the device operating manual. 10. No person or facility should advertise the use of any Ultraviolet A or Ultraviolet B tanning device as having positive health benefits or using wording such as “safe,” “safe tanning,” “no harmful rays,” “no adverse effect,” or similar wording or concepts. In addition, advertisements touting benefits of vitamin D should contain a disclosure: “You do not need to become tan for your skin to make vitamin D. The safest way to obtain vitamin D is through diet and supplementation.1 Exposure to ultraviolet radiation is a known risk factor in the development of melanoma and non-melanoma skin cancers.”

1 Ross AC, Manson JE, Abrams SA, Aloia JF, Brannon PM, Clinton SK, et al. The 2011 Report on Dietary Reference Intakes for Calcium and Vitamin D from the Institute of Medicine: What Clinicians Need to Know. J Clin Endocrinol Metab Nov 29 2010 (epub ahead of print) Promotion of frequent tanning sessions by indoor tanning facilities: Two studies

Harry T. Kwon, MPH, CHES,a Joni A. Mayer, PhD,a Kristina K. Walker, MPH,a Henry Yu, MPH,a Elizabeth C. Lewis, MPH,a and George E. Belch, PhDb San Diego, California

Background: Indoor tanning may increase the risk of melanoma and other health problems. Frequent users of indoor tanning facilities may be at particularly high risk. Objective: In study 1 our purpose was to assess the prevalence and nature of indoor tanning advertisements; in study 2 we aimed to assess tanning facility compliance to recommended exposure schedules. Methods: In study 1, tanning facility advertisements over a 4-month period from 24 San Diego County newspapers were monitored. In study 2, we assessed compliance with recommended exposure schedules via a telephone interview of 60 San Diego County tanning facilities. Results: Approximately 75% of the indoor tanning advertisements promoted unlimited tanning. Only 5% of facilities were in compliance with recommended tanning schedules, and 100% offered “unlimited” tanning packages. Conclusions: These findings suggest that the indoor tanning industry, through pricing incentives that allow frequent sessions, may be promoting overexposure to UVR. Stronger legislation is needed to address this issue. (J Am Acad Dermatol 2002;46:700-5.)

ith an expected one million new cases per beds use fluorescent light bulbs that emit mostly year, skin cancer is the most common of all UVA rays and deliver up to 3 times the UVA dose cancers and accounts for nearly half of all delivered by natural sunlight.5 W 1 cancer cases. Since the 1970s, the incidence rate of The demand for tanned skin has yielded an expo- melanoma has increased significantly to about 4% nential growth of tanning facilities in recent years. It annually and will account for more than 9000 deaths is estimated that there are 28 million users of tanning this year.1 The link between exposure to solar ultra- facilities and 50,000 tanning facilities nationwide, violet radiation (UVR) and skin cancer is well accept- producing a billion dollar industry.* In San Diego ed by the scientific community.2 Although the County alone, there are more than 100 tanning facil- studies assessing the relationship between indoor ities located within county lines. An estimated 5% of tanning (ie, exposure to artificial UVR) and the US population are regular users of tanning beds.6 melanoma have yielded mixed results, there now are Because of the growth of the tanning facility at least 7 studies that show a significant, elevated industry, the Food and Drug Administration (FDA) risk.3,4 Most of the studies documented some form has established guidelines that limit amounts of UVR of a dose-response relationship.3 Modern tanning to a person. Currently, the recommended exposure schedule is “no more than 0.75 minimal erythemal dose (MED) 3 times the first week,” gradually From the Graduate School of Public Healtha and the Department of increasing the exposure thereafter.7 The Federal Marketing,b San Diego State University. Funding: None. Trade Commission investigates deceptive and false Conflict of interest: None. advertising of tanning devices, including claims that Accepted for publication May 31, 2001. indoor tanning is safe.8 Approximately one half of Reprint requests: Joni A. Mayer, PhD, Graduate School of Public the states have passed tanning facility regulations.9 Health–Hardy Tower 119, San Diego State University, San Diego, CA 92182-4162. E-mail: [email protected]. Copyright © 2002 by the American Academy of Dermatology, Inc. *Cyr WH. CDRH evaluation of UV-emitting sunlamp products. In: 0190-9622/2002/$35.00 + 0 16/1/119560 Proceedings of the Centers for Disease Control and Prevention doi:10.1067/mjd.2002.119560 conference, San Diego, Calif, Feb 18, 1999.

700 J AM ACAD DERMATOL Kwon et al 701 VOLUME 46, NUMBER 5

California’s Filante Tanning Facility Act of 1988 states ment. “Unlimited tanning advertisement” was that tanning facilities must (1) give each customer a defined as any advertisement that fulfilled the defi- written statement warning them about specific risks nition above and included the following terms or (eg, not using eye protection may cause eye damage, offers: unlimited tanning, no limit tanning, tanning repeated exposure may cause skin cancer); (2) post packages without a specified period of time to ren- warning signs related to UVR; (3) not claim that der services, packages with 3 or more sessions with- using a tanning device is safe; (4) have sufficiently in one week, monthly tanning packages, or if time trained operators present; (5) provide each cus- period to render tanning services was not specified. tomer with sanitized protective eyewear and man- Additional characteristics recorded for the tan- date use of the eyewear; (6) show each customer ning advertisement included date printed, source of how to use the device properly; (7) use an accurate advertisement, type of printed media, location of timer during each session; (8) limit each customer to advertisement (section), classification of unlimited the manufacturer’s recommended maximum expo- tanning, and cost of service. In addition, each adver- sure time; (9) obtain signed informed consent from tisement was examined to see whether it was in each customer acknowledging understanding of the accordance with California’s Filante Tanning Facility warnings; (10) obtain signed parental consent for Act of 1988, which prohibits the distribution of pro- customers aged 14 to 18 years; and (11) require that motional material claiming that use of a tanning customers younger than 14 years be accompanied by device (tanning bed) was safe or free from risk.10 a parent or legal guardian.10 Twenty-four newspapers were examined over a 4- In a previous study recently published in this month period during the winter/early spring season Journal, our research group found that 94.4% of 54 of 1999-2000. Attainment of newspapers was accom- indoor tanning facilities in San Diego County were plished in 3 ways: archival retrieval at local libraries; allowing a session per day the first week of tanning.11 issue picked up at drop-off locations; and, if applica- During that study, the investigators informally encoun- ble, visiting publishers to examine issues. When tered promotional incentives that provided “unlimit- tanning advertisements were found, they were pho- ed” tanning for a flat monthly rate. Subsequently, we tocopied or excised, labeled with a record identifica- conducted the two studies reported in this article to tion number, and catalogued onto a data record list. focus specifically on the issue of promoting frequent Data were entered into the Statistical Package for tanning sessions. In study 1, we systematically moni- the Social Sciences (SPSS); the issue of the newspa- tored newspapers in San Diego County, California, to per was the unit of analysis. Descriptive data were assess the rate of “unlimited” tanning ads. To our calculated for all variables. Assessments of the preva- knowledge, this was the first study to evaluate promo- lence of tanning advertisements in newspapers were tional strategies for soliciting indoor tanning facility made by examining the percentage of the issues that customers. In study 2, we conducted a partial replica- contained an advertisement. Of these advertise- tion of our earlier facility compliance study,11 with ments, the percentage promoting unlimited tanning emphasis on the number of sessions allowed by oper- was computed. A test of association between tanning ators during a customer’s first week and the rate of advertisement and type of newspaper was conduct- “unlimited” tanning fee packages. ed with a chi-square test.

METHODS Study 2 Study 1 Study 2 used a cross-sectional design consisting of Study 1 consisted of a systematic evaluation of telephone interviews of tanning facility operators in promotional tanning advertisements in local news- San Diego County. The sample consisted of 60 tanning papers. The sample included 24 local newspapers facilities in San Diego County. A tanning facility was representing a variety of readerships in San Diego defined as any location, place, area, structure, or busi- County. The publications were selected from the var- ness that provided persons access to any tanning ious geographic regions of San Diego County and device (California Statute of 1988, Chapter 23, Section consisted of daily city-wide, collegiate, community, 22702, Part A).10 A list of tanning facilities in San Diego and entertainment newspapers. County was created by means of a document search The following operational definitions were used through Pacific Bell Yellow Pages and by the Internet to quantify the rates of advertisements. “Tanning through the search engines of the World Wide Web. advertisement” was defined as any advertisement or The search term selected for both electronic and reference located within a newspaper that included paper directories was “tanning salon,” and the regions the word “tanning” and referred to a service provid- selected were San Diego, San Diego County, and the ed by the business represented in the advertise- area codes of 619, 858, and 760. Inclusion criteria 702 Kwon et al J AM ACAD DERMATOL MAY 2002

reviewed by and received approval from the Committee on Protection of Human Subjects at San Diego State University. The SPSS was used for all statistical analyses. Descriptive statistics were computed for all variables. Frequencies were calculated for categorical variables. Chi-square tests were used to test the association between compliance of tanning sessions recommended for the first week and gender of the operator and the type of facility (eg, salon, gym). Percent agreement and the κ statistical test were used to assess the interrater reliability between the two interviewers.

Fig 1. Frequency of tanning advertisements over 4 RESULTS months. Study 1 Sample characteristics and prevalence of advertisements. A total of 584 newspaper issues included any facility that was in business and had at out of 606 eligible issues was examined over a 4- least one operable tanning bed. Random selection was month period. Twenty-two issues were not examined used for tanning facilities that were part of a chain (>1 either because the issue was missing or because it facility with the same business name). One facility rep- was not recovered. The sample comprised 14 com- resenting each chain was selected. munity papers (189 issues, 32% of all issues), 4 col- The principal outcome variables in study 2 were legiate (84 issues, 14%), 4 entertainment/special tanning facility compliance with recommended interest (68 issues, 12%), and 2 major daily newspa- exposure schedule guidelines and prevalence of tan- pers (243 issues, 42%). ning session packages and pricing structures. Data Seventy-three tanning advertisements were found were collected in March 2000 by telephone by a 24- and recorded. Based on the operational definition of year-old male confederate (H. T. K.) who posed as a an unlimited tanning advertisement, 55 tanning prospective customer. The confederate prefaced his advertisements (75.3%) were labeled as offering target questions by indicating he had fair skin and unlimited tanning packages. In addition, 7 tanning was planning to vacation in Acapulco in a couple of advertisements (9.6%) were found to promote safe weeks. He then asked the operator about (1) the tanning devices, which is a violation of the California operator’s personal recommendation for the most Filante Tanning Facility Act of 1988 and Federal Trade number of times he should tan the first week, (2) the Commission regulations. duration per session, (3) the kinds of packages Price data. Promotional prices located in the offered by the facility, and (4) whether the facility advertisement were recorded if the tanning advertise- offered “unlimited” tanning. Facilities were consid- ment had a monthly-unlimited package price or ered compliant if the operator’s responses were economic incentive. For promotional prices in adver- within the FDA’s recommended exposure guidelines tisements with more than 1 month of tanning at a spe- on the frequency of sessions.7 For the duration of cific price, a monthly average cost was computed. The each session, the FDA’s recommendation is stated in average cost of an unlimited monthly tanning package terms of MED rather than minutes. Consequently, to was $29.86 (standard deviation [SD], $3.21). Forty- conduct the assessment of compliance with dura- one tanning advertisements (56.2%) were linked to a tion, we adopted the limit used in a recommenda- facility chain. Of those chains, 31 advertisements rep- tion of the Council on Scientific Affairs, American resented a chain of 4 facilities and 10 advertisements Medical Association2; we coded maximum durations represented a chain of 5 or more facilities, all within of 30 minutes or less as compliant. the San Diego metropolitan area. As shown in Fig 1, a To assess reliability, all facilities were interviewed a seasonal pattern of a number of advertisements dis- second time by a different interviewer. This inter- played was found. More tanning advertisements (gen- viewer was a 25-year-old male graduate student. A eral and unlimited) were prevalent toward the end of modified script and a subset of the initial questions the 4-month period. were used. To assess further point-to-point reliabili- Associations between newspaper type and ty, the first name of the tanning facility operator from advertisement prevalence. Table I presents the the primary and secondary interview was recorded proportions of newspapers, by type, that contained at and matched when applicable. Both studies were least one tanning advertisement and at least one J AM ACAD DERMATOL Kwon et al 703 VOLUME 46, NUMBER 5

Table I. Association between tanning advertisements and type of newspaper

Major Entertainment Collegiate Community Advertisements No. (%) No. (%) No. (%) No. (%) χ2 (df) P value

Had tanning ad 0 (-)* 18 (26.5%)† 16 (19.0%) 1 (0.5%)* 101.53 (3) <.001 Had unlimited tanning ad 0 (-)* 18 (26.5%)† 14 (16.7%) 1 (0.5%)* 98.26 (3) <.001

*Significantly different from other types, but not from each other. †Significantly different from collegiate types.

Table II. Percentage agreement between observers and κ statistics

Same operator (n = 15) Different operator (n = 45)

Item Percentage agreement κ Percentage agreement κ

Sex 100.0 1 77.3 .335 Frequency/week 60.0* — 42.2* — Duration/session 53.4* — 58.5 .131 Have unlimited tanning 100.0† — 100.0† —

The following cut-offs for interpreting reliability from the kappas were used: 0 to 0.4 = marginal, 0.4 to 0.75 = good, 0.75 to 1 = excellent. *κ could not be computed because row values did not equal column values in a table. †κ could not be computed because the number of nonempty rows and columns equaled 1. unlimited tanning advertisement, as well as the Table III. Summary of tanning facility response to results of the chi-square analysis. As noted, type of interview questions newspaper was significantly associated with both the No. of tanning presence of any tanning ad and the presence of an Item and response facilities % unlimited ad. Post hoc multiple comparisons indicated that major and community types of newspapers Frequency during first week had significantly smaller proportions of tanning Everyday 37 61.7 advertisements than the other types of newspapers Every other day 17 28.3 (collegiate and entertainment), but were not different Three or less 4 6.7 from each other. Entertainment newspapers had sig- Unable to determine* 2 3.3 Duration per session nificantly larger proportions of tanning advertise- 3-5 min 2 3.3 ments than collegiate newspapers. Multitude compar- 6-10 min 44 73.3 isons for unlimited tanning yielded parallel findings. 11-15 min 6 10 16-20 min 5 8.3 Study 2 Unable to determine* 3 5 Sample characteristics. A total of 60 telephone Have unlimited tanning interviews was conducted. From an initial sample of Yes 60 100 90 tanning facilities, 30 facilities did not meet the Come in as much as I want inclusion criteria, including no longer having opera- Yes 43 71.7 ble tanning beds or being out of business. The tan- Only once per day 17 28.3 ning facility sample consisted of 51 tanning salons *Respondents replied that they needed to see the customer before (85%), 5 gym/fitness centers (8.3%), and 4 hair/beau- giving an answer. ty salons (6.7%). Respondents included 17 male and 43 female tanning facility operators. The average completion time of the primary interview was 3.23 min- ers. These data are shown in Table II. κ Values for 5 of utes (SD, 0.96; range, 2-6 minutes). the 8 variables could not be computed. With the raw Interobserver reliability. Percent agreement percentage agreement data, agreement ranged from between observers and κ statistic values for inter- 42.2% to 100%, with generally higher agreement views with the same or different operator by both found for observations of the same operator. interviewers were calculated. Fifteen of the facility Compliance and other outcomes. Table III operators (25%) were interviewed by both interview- presents the distribution of responses to the confed- 704 Kwon et al J AM ACAD DERMATOL MAY 2002

erate’s key questions. Only 4 of 58 specific respons- monthly unlimited tanning package price based on es (6.8%) to the first-week-session-frequency recom- our interview data, we estimate that a consumer tan- mendation were classified as compliant (≤ 3 times ning daily over a 30-day period would pay approxi- per week). In contrast, of the 57 operators who gave mately $1.28 per session. In contrast, the single ses- a specific number of minutes for the duration rec- sion price was $6.48. (The monthly rates of these ommendation, all responded with a duration of less strategies are $38.50 and $194.40, respectively.) than 30 minutes and were considered compliant. We do not have direct evidence that the package Tests of association were performed to assess rela- pricing strategy promotes greater session frequency tionships between compliance with recommenda- (and cumulative exposure) than the individual ses- tions and gender of operator and facility type (eg, sion strategy. However, it is likely that the former salon, gym). No statistically significant chi-square val- strategy attracts a larger number of first-time users, ues were found between any of the compliance out- given that it provides an 80% discount. This discount comes and either operator gender or facility type. may be particularly attractive to adolescents, who may All 60 facilities (100%) reported offering unlimited have less money, place a high value on being tanning packages. Fifty-four facilities released tanned,14 and may be at greater risk for skin cancer monthly-unlimited tanning package prices over the than adults because of cumulative UVR exposure.15-17 phone. The average cost per month of an unlimited Young age (16-24 years) predicted sunbed use among tanning package was $38.50 (SD, $8.10). The range New York state residents18 and a survey of adoles- of reported prices was from $15 to $55. During the cents in St. Paul showed high rates of indoor tanning, second (reliability) interview, 59 of the 60 facilities particularly among girls.19 released single tanning session prices; these were Both studies had methodologic limitations. Study not assessed during the primary interview. The aver- 1 would have been strengthened by sampling news- age cost of a single tanning session was $6.48 (SD, papers over a 12-month period and by obtaining reli- $1.16). The prices ranged from $4 to $10 per session. ability estimates. In study 2, respondents reported their practices for a future visit; these data may not DISCUSSION correlate with the practices during an actual visit. In A key convergent finding from these two studies addition, the interconfederate agreement estimates was the frequent use by indoor tanning facilities of were relatively low for some of the variables. The “unlimited” tanning packages as a promotional strat- lack of concordance may be explained, in part, by egy. Three fourths of the print ads used this strategy, interviewing different operators at most of the facili- and all of the facilities in our sample offered it as a ties. It may also reflect a lack of consistency in what payment option. Compatible with this practice, the one operator says to different clients. Finally, all majority of facility operators indicated they would indoor tanning facilities in San Diego County may allow a fair-skinned confederate to tan at high fre- not have been listed in the Yellow Pages or Internet quencies (that exceed the FDA’s recommended directories. Furthermore, beauty salons and other guidelines). Although our data on tanning duration businesses offering indoor tanning as an ancillary were more encouraging, allowing such frequent ses- service may not have had a listing under “tanning sions nevertheless may result in consumers’ overex- salons.” Thus the search strategy may have omitted posure to UVR. some tanning businesses. In future studies, supple- Not surprisingly, because this 2000 sample of local mental databases, such as American Business Disc facilities overlapped with the sample in our 1998 and Dun & Bradstreet Marketing Service, should be study,11 the patterns of compliance were compara- used to identify potential sites. ble, with low compliance with the frequency recom- As stated in our earlier article,11 to improve con- mendation and high compliance with the duration sumer safety we recommend mandatory operator limit. Other studies also have reported low compli- training and systematic enforcement of existing reg- ance with the frequency guidelines.12,13 ulations. Because the session frequency criterion is To our knowledge, ours are the only studies to only a recommendation, federal, state, and local pol- date that have systematically examined pricing strate- icy-makers should consider changing it to a regula- gies. The average package price quoted in the ads tion. (The FDA currently is considering revisions to (study 1) was lower than the average price given by sunlamp product performance standards.20) Finally, facility operators in the study 2 interviews. This may additional exploration is warranted of the “unlimit- have been due to a greater tendency of lower priced ed” tanning promotional strategies. Researchers facilities (relative to higher priced facilities) to adver- need to systematically evaluate the specific impacts tise and/or to the occurrence of one-time-only pro- these strategies have on facility use, particularly motional prices quoted in the ads. Using the mean among adolescents. In the meantime, given the J AM ACAD DERMATOL Kwon et al 705 VOLUME 46, NUMBER 5

widespread use of these strategies, health advocates 10. California Department of Health Services, Department of should develop interventions targeted at consumers Consumer Affairs. Filante Tanning Facility Act of 1988. Business (and their parents), informing them about exposure and Professions Code; Chapter 23-22700-08 1998. 11. Culley CA, Mayer JA, Eckhardt L, Busic AJ, Eichenfield LF,Sallis JF, guidelines. As one intervention component, select et al. Compliance with federal and state legislation by indoor communications could be placed in the same media tanning facilities in San Diego.J Am Acad Dermatol 2001;44:53- that print indoor tanning advertisements. 60. 12. Bruyneel-Rapp F,Dorsey SB, Guin JD.The tanning salon: an area REFERENCES survey of equipment, procedures, and practices. J Am Acad 1. American Cancer Society. Cancer facts and figures, 2000. Dermatol 1988;18:1030-8. Atlanta: American Cancer Society; 2000. 13. Fairchild A, Gemson D. Safety information provided to cus- 2. Council on Scientific Affairs. Harmful effects of ultraviolet radia- tomers of New York City suntanning salons. Am J Prev Med tion. JAMA 1989;262:380-4. 1992;8:381-3. 3. Swerdlow AJ, Weinstock MA. Do tanning lamps cause 14. Mermelstein RJ, Riesenberg LA. Changing knowledge and atti- melanoma? An epidemiologic assessment. J Am Acad Dermatol tudes about skin cancer risk factors in adolescents. Health 1998;38:89-98. Psychol 1992;11:371-6. 4. Westerdahl J, Ingvar C, Måsbäck A, Jonsson N, Olsson H. Risk of 15. Marks R. An overview of skin cancers: incidence and causation. cutaneous malignant melanoma in relation to use of sunbeds: Cancer Suppl 1995;75:607-12. further evidence for UV-A carcinogenicity. Br J Cancer 2000; 16. Marks R. Skin cancer—childhood protection affords lifetime 82:1593-9. protection. Med J Aust 1997;147:475-6. 5. Diffey BL. Use of UV-A sunbeds for cosmetic tanning. Br J 17. Weinstock MA, Colditz GA, Willett WC, Stampfer MJ, Bronstein Dermatol 1986;115:67-76. BR,Mihm MC,et al.Nonfamilial cutaneous melanoma incidence 6. DeLeo VA. Tanning salons. In: American Academy of in women associated with sun exposure before 20 years of age. Dermatology, editors. Proceedings of national conference on Pediatrics 1989;84:199-204. environmental hazards to the skin, October 1992. Schaumburg 18. Lillquist PP, Baptiste MS, Witzigman MA, Nasca PC. A popula- (IL): American Academy of Dermatology; 1994. p. 37-41. tion-based survey of sun lamp and tanning parlor use in New 7. US Department of Health and Human Services. Quality control York State, 1990. J Am Acad Dermatol 1994;31:510-2. guide for sunlamp products. Rockville (MD): Public Health 19. Oliphant JA, Forster JL, McBride CM.The use of commercial tan- Service; 1988. DHHS Publication No. FDA 88-8234. ning facilities by suburban Minnesota adolescents. Am J Public 8. Federal Trade Commission. Indoor tanning (factsheet); 1997 Health 1994;84:476-8. [online]. Available at: URL: http://www.ftc.gov/bcp/conline/ 20. Department of Health and Human Services, Food and Drug pubs/health/indootan.htm. Accessed January 15, 2000. Administration. Medical devices; sunlamp products perform- 9. American Academy of Dermatology. American Academy of ance standard; requests for comments and information, pro- Dermatology summary of tanning parlor legislation; posed rule (21 CFR § 1020). Fed Reg 1999;64:6288-90. Schaumburg (IL): American Academy of Dermatology; 1995. 63rd Legislature HB0028.01

1 HOUSE BILL NO. 28

2 INTRODUCED BY L. BANGERTER

3 BY REQUEST OF THE CHILDREN, FAMILIES, HEALTH, AND HUMAN SERVICES INTERIM COMMITTEE

5 A BILL FOR AN ACT ENTITLED: "AN ACT REVISING THE FETAL, INFANT, AND CHILD MORTALITY

6 PREVENTION ACT TO ALLOW FOR REVIEW OF MATERNAL MORTALITY; ESTABLISHING MEMBERSHIP

7 REQUIREMENTS FOR TEAMS REVIEWING MATERNAL DEATHS; REVISING CONFIDENTIALITY

8 REQUIREMENTS; AND AMENDING SECTIONS 50-16-522, 50-16-804, 50-16-805, 50-19-401, 50-19-402,

9 50-19-403, AND 50-19-404, MCA."

11 BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF MONTANA:

13 Section 1. Section 50-16-522, MCA, is amended to read:

14 "50-16-522. Representative of deceased patient. A Except as provided in 50-19-402, a personal

15 representative of a deceased patient may exercise all of the deceased patient's rights under this part. If there is

16 no personal representative or upon discharge of the personal representative, a deceased patient's rights under

17 this part may be exercised by the surviving spouse, a parent, an adult child, an adult sibling, or any other person

18 who is authorized by law to act for the deceased patient."

20 Section 2. Section 50-16-804, MCA, is amended to read:

21 "50-16-804. Representative of deceased patient's estate. A Except as provided in 50-19-402, a

22 personal representative of a deceased patient's estate may exercise all of the deceased patient's rights under

23 this part. If there is no personal representative or upon discharge of the personal representative, a deceased

24 patient's rights under this part may be exercised by the surviving spouse, a parent, an adult child, an adult sibling,

25 or any other person who is authorized by law to act for the deceased person."

27 Section 3. Section 50-16-805, MCA, is amended to read:

28 "50-16-805. Disclosure of information for workers' compensation and occupational disease

29 claims and law enforcement purposes allowed for certain purposes. (1) To the extent provided in 39-71-604

30 and 50-16-527, a signed claim for workers' compensation or occupational disease benefits authorizes disclosure

- 1 - Authorized Print Version - HB 28 63rd Legislature HB0028.01

1 to the workers' compensation insurer, as defined in 39-71-116, by the health care provider.

2 (2) A health care provider may disclose health care information about an individual for law enforcement

3 purposes if the disclosure is to:

4 (a) federal, state, or local law enforcement authorities to the extent required by law; or

5 (b) a law enforcement officer about the general physical condition of a patient being treated in a health

6 care facility if the patient was injured by the possible criminal act of another.

7 (3) A health care provider may disclose health care information to a fetal, infant, child, and maternal

8 mortality review team for the purposes of 50-19-402."

10 Section 4. Section 50-19-401, MCA, is amended to read:

11 "50-19-401. Short title. This part may be cited as the "Fetal, Infant, and Child, and Maternal Mortality

12 Prevention Act"."

14 Section 5. Section 50-19-402, MCA, is amended to read:

15 "50-19-402. Statement of policy -- access to information. (1) The prevention of fetal, infant, and child,

16 and maternal deaths is both the policy of the state of Montana and a community responsibility. Many community

17 professionals have expertise that can be used to promote the health, safety, and welfare of fetuses, infants, and

18 children, and postnatal women. The use of these professionals in reviewing fetal, infant, and child, and maternal

19 deaths can lead to a greater understanding of the causes of death and the methods of preventing deaths. It is

20 the intent of the legislature to encourage local communities to establish voluntary multidisciplinary fetal, infant,

21 and child, and maternal mortality review teams to study the incidence and causes of fetal, infant, and child, and

22 maternal deaths and to make recommendations for community or statewide change, if appropriate, that may help

23 prevent future deaths.

24 (2) (a) A health care provider may disclose information about a patient without the patient's authorization

25 or without the authorization of the representative of a patient who is deceased upon request of a local fetal, infant,

26 and child, and maternal mortality review team. The review team may request and may receive information from:

27 (i) a county attorney as provided in 44-5-303(4), from;

28 (ii) a tribal attorney, and from; and

29 (iii) a health care provider as permitted in:

30 (A) Title 50, chapter 16, part 5, or 8; or

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1 (B) applicable federal law.

2 (b) The review team shall maintain the confidentiality of the information received.

3 (3) (a) The local fetal, infant, and child, and maternal mortality review team may:

4 (a)(i) perform an indepth analysis of fetal, infant, and child deaths, including a review of records available

5 by law;

6 (ii) perform an indepth analysis of maternal deaths that occur within a year of the time a woman gave

7 birth;

8 (b)(iii) compile statistics of fetal, infant, and child, and maternal mortality and communicate the statistics

9 to the department of public health and human services for inclusion in statistical reports;

10 (c)(iv) analyze the preventable causes of fetal, infant, and child, and maternal deaths, including child

11 abuse and neglect and postpartum complications; and

12 (d)(v) recommend measures to prevent future fetal, infant, and child, and maternal deaths.

13 (b) The analysis authorized under this subsection (3) may include a review of records available by law.

14 (4) A local fetal, infant, and child, and maternal mortality review team may not review deaths of under

15 this section if:

16 (a) the deaths involve fetuses, infants, or children, or women who are Indians and which deaths;

17 (b) the deaths occur within the boundaries of an Indian reservation with a; and

18 (c) the tribal government that opposes the review."

20 Section 6. Section 50-19-403, MCA, is amended to read:

21 "50-19-403. Local fetal, infant, and child, and maternal mortality review team. (1) A local fetal, infant,

22 and child, and maternal mortality review team must be approved by the department of public health and human

23 services. Approval may be given if:

24 (a) the county health department, a tribal health department, if the tribal government agrees, or both are

25 represented on the team and the plan provided for in subsection (1)(d) (1)(e) includes the roles of the county

26 health department, tribal health department, or both;

27 (b) a lead person has been designated for the purposes of management of the review team;

28 (c) at least five of the individuals listed in subsection (2) have agreed to serve on the review team; and

29 (d) a team reviewing a maternal death includes at least one obstetrician or one family practice physician;

30 and

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1 (d)(e) a plan has been developed by the team has developed a plan that includes, at a minimum,

2 operating policies of the review team covering collection and destruction of information obtained pursuant to

3 44-5-303(4) or 50-19-402(2).

4 (2) If a local fetal, infant, and child, and maternal mortality review team is established, the team must be

5 multidisciplinary and may include only:

6 (a) the county attorney or a designee;

7 (b) a law enforcement officer;

8 (c) the medical examiner or coroner for the jurisdiction;

9 (d) a physician;

10 (e) a school district representative;

11 (f) a representative of the local health department;

12 (g) a representative from a tribal health department, appointed by the tribal government;

13 (h) a representative from a neighboring county or tribal government if there is an agreement to review

14 deaths for that county or tribe;

15 (i) a representative of the department of public health and human services;

16 (j) a forensic pathologist;

17 (k) a pediatrician;

18 (l) a family practice physician;

19 (m) an obstetrician;

20 (n) a nurse practitioner;

21 (o) a public health nurse;

22 (p) a mental health professional;

23 (q) a local trauma coordinator;

24 (r) a representative of the bureau of Indian affairs or the Indian health service, or both, who is located

25 within the county; and

26 (s) representatives of the following:

27 (i) local emergency medical services;

28 (ii) a local hospital;

29 (iii) a local hospital medical records department;

30 (iv) a local governmental fire agency organized under Title 7, chapter 33; and

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1 (v) the local registrar.

2 (3) The designated lead person for the team shall submit membership lists to the department of public

3 health and human services annually."

5 Section 7. Section 50-19-404, MCA, is amended to read:

6 "50-19-404. Records -- confidentiality. Material and information obtained by a local fetal, infant, and

7 child, and maternal mortality review team are not subject to disclosure under the public records law. Material and

8 information obtained by a local fetal, infant, and child mortality review team are not subject to subpoena."

10 NEW SECTION. Section 8. Notification to tribal governments. The secretary of state shall send a

11 copy of [this act] to each tribal government located on the seven Montana reservations and to the Little Shell

12 Chippewa tribe.

13 - END -

- 5 - Authorized Print Version - HB 28 63rd Legislature LC0670.01