Rules of Department of Social Services Division 70—MO HealthNet Division Chapter 20—Pharmacy Program

Title Page

13 CSR 70-20.010 Participating Drug Vendors (Rescinded September 30, 2018) ...... 3 13 CSR 70-20.030 Drugs Covered by Medicaid ...... 3 13 CSR 70-20.031 List of Excludable Drugs for Which Prior Authorization Is Required ...... 4 13 CSR 70-20.032 List of Excludable Drugs Excluded From Coverage Under the MO HealthNet Pharmacy Program...... 4 13 CSR 70-20.033 Medicaid Program Coverage of Investigational Drugs Used in the Treatment of Acquired Immunodeficiency Syndrome (AIDS) (Rescinded September 30, 2018)...... 4 13 CSR 70-20.034 List of Non-Excludable Drugs for Which Prior Authorization Is Required ...... 5 13 CSR 70-20.040 Five Prescription Limit Per Month Per Recipient...... 5 13 CSR 70-20.045 Thirty-One Day Supply Maximum Restriction on Pharmacy Services Reimbursed by the MO HealthNet Division ...... 6 13 CSR 70-20.050 Return of Drugs...... 7 13 CSR 70-20.060 Professional Dispensing Fee ...... 7 13 CSR 70-20.070 Computer-Generated Drug Pricing Tape and Drug Reimbursement Methodology...... 8 13 CSR 70-20.071 Multiple Source Drugs for Which There Exists a Federal Upper Limit on Reimbursement (Rescinded September 30, 2018)...... 8 13 CSR 70-20.080 Labeling of Medicaid Prescriptions (Rescinded December 9, 1993) ...... 8 13 CSR 70-20.100 Missouri Nonsteroidal Anti-Inflammatory Drug List (Rescinded September 30, 1991)...... 8 13 CSR 70-20.110 Medicaid Program Coverage of Approved Drugs for Treatment of Acquired Immunodeficiency Syndrome (AIDS) (Rescinded September 30, 1991)...... 8 13 CSR 70-20.120 Medicaid Program Coverage of Anti-Ulcer Preparations (Rescinded June 29, 1989) ...... 9

JOHN R. ASHCROFT (10/31/18) CODE OF STATE REGULATIONS 1 Secretary of State 13 CSR 70-20.200 Drug Prior Authorization Process ...... 9 13 CSR 70-20.250 Prior Authorization of New Drug Entities or New Drug Dosage Form ...... 10 13 CSR 70-20.300 Retrospective Drug Use Review Process...... 11 13 CSR 70-20.310 Prospective Drug Use Review Process and Patient Counseling ...... 12 13 CSR 70-20.320 Pharmacy Reimbursement Allowance...... 13 13 CSR 70-20.330 Medication Therapy Management (MTM) Program ...... 14 13 CSR 70-20.340 National Drug Code Requirement...... 15

2 CODE OF STATE REGULATIONS (10/31/18) JOHN R. ASHCROFT Secretary of State Chapter 20—Pharmacy Program 13 CSR 70-20

Title 13—DEPARTMENT OF exceptions: those products identified as Drug expired April 10, 1982. Emergency amend- SOCIAL SERVICES Efficacy Study Implementation (DESI) drugs ment filed Jan. 21, 1982, effective Feb. 1, Division 70—MO HealthNet Division by the federal Food and Drug Administration 1982, expired April 10, 1982. Amended: Chapter 20—Pharmacy Program (FDA); products considered by the federal Filed Dec. 21, 1981, effective April 11, 1982. FDA to be similar, identical or related to a Emergency amendment filed July 22, 1982, 13 CSR 70-20.010 Participating Drug DESI product; products identified in 13 CSR effective Aug. 1, 1982, expired Nov. 10, Vendors 70-20.031 and 13 CSR 70-20.032; and prod- 1982. Amended: Filed July 22, 1982, effec- (Rescinded September 30, 2018) ucts not meeting the definition of drug in sec- tive Nov. 11, 1982. Emergency amendment tions 505, 506 and 507 of the federal Food, filed Sept. 30, 1982, effective Oct. 10, 1982, AUTHORITY: section 207.020, RSMo 1986. Drug and Cosmetic Act. expired Jan. 28, 1983. Amended: Filed Jan. This rule was previously filed as 13 CSR 40- 14, 1983, effective May 12, 1983. Amended: 81.011. Original rule filed Nov. 13, 1978, (3) According to the federal Social Security Filed July 13, 1983, effective Oct. 13, 1983. effective Feb. 11, 1979. Rescinded: Filed Act, section 1927(a)(1) in order for federal Emergency amendment filed Dec. 21, 1983, March 2, 2018, effective Sept. 30, 2018. financial participation to be available for cov- effective Jan. 1, 1984, expired March 30, ered outpatient drugs of a manufacturer, the 1984. Emergency amendment filed March 21, manufacturer must have entered into and have 1984, effective March 31, 1984, expired July 13 CSR 70-20.030 Drugs Covered by in effect a rebate agreement with the secre- 11, 1984. Amended: Filed March 21, 1984, Medicaid tary of the federal Department of Health and effective July 12, 1984. Emergency amend- Human Services. States are periodically noti- ment filed April 20, 1984, effective May 1, PURPOSE: This rule implements recent fied by the federal Health Care Financing 1984, expired July 11, 1984. Amended: Filed changes in drug coverage as mandated by Administration of manufacturers that have June 13, 1984, effective Sept. 14, 1984. federal Health Care Financing Administra- entered into as well as terminated rebate Amended: Filed Sept. 12, 1984, effective Jan. tion. agreements with the secretary of the federal 12, 1985. Amended: Filed Jan. 15, 1985, Department of Health and Human Services. effective April 11, 1985. Amended: Filed (1) Limiting Definition—As defined in the The Missouri Medicaid Pharmacy Manual April 16, 1985, effective July 11, 1985. Social Security Act, section 1927(k)(3), the and updating bulletins shall provide the Amended: Filed Oct. 2, 1985, effective Jan. term covered outpatient drug does not include detailed listing of manufacturers that have in 1, 1986. Amended: Filed April 16, 1986, any drug, biological product, or insulin pro- effect a rebate agreement with the federal effective July 1, 1986. Amended: Filed Sept. vided as part of, or as incident to and in the Department of Health and Human Services. 17, 1986, effective Dec. 1, 1986. Amended: same setting as any of the following (and for Filed Nov. 14, 1986, effective Feb. 12, 1987. which payment may be made under this title AUTHORITY: section 208.152, 208.153, and Emergency amendment filed Dec. 18, 1986, as part of payment for the following and not 208.201, RSMo. 1994.* This rule was previ- effective Jan. 1, 1987, expired Feb. 11, 1987. as direct reimbursement for the drug): ously filed as 13 CSR 40-81.010. Original Amended: Filed Feb. 18, 1987, effective May “(A) Inpatient hospital services. rule filed Jan. 21, 1964, effective Jan. 31, 1, 1987. Amended: Filed April 17, 1987, “(B) Hospice services. 1964. Amended: Filed March 30, 1964, effective July 1, 1987. Amended: Filed June “(C) Dental services, except that drugs for effective April 10, 1964. Amended: Filed 16, 1987, effective Sept. 1, 1987. Amended: which the state plan authorized direct reim- April 27, 1965, effective May 7, 1965. Filed Aug. 18, 1987, effective Nov. 12, 1987. bursement to the dispensing dentist are cov- Amended: Filed Dec. 7, 1966, effective Dec. Amended: Filed Dec. 1, 1987, effective Feb. ered outpatient drugs. 17, 1966. Amended: Filed Oct. 11, 1967, 11, 1988. Amended: Filed April 4, 1988, “(D) Physicians’ services. effective Oct. 21, 1967. Amended: Filed Oct. effective July 1, 1988. Amended: Filed July “(E) Outpatient hospital services. 19, 1967, effective Oct. 29, 1967. Amended: 15, 1988, effective Oct. 13, 1988. Amended: “(F) Nursing facility services and services Filed Jan. 22, 1968, effective Feb. 2, 1968. Filed Sept. 15, 1988, effective Dec. 11, 1988. provided by an intermediate care facility for Amended: Filed Aug. 24, 1968, effective Amended: Filed April 4, 1989, effective July the mentally retarded. Sept. 4, 1968. Amended: Filed April 16, 1, 1989. Amended: Filed June 6, 1989, effec- “(G) Other laboratory and x-ray services. 1970, effective April 26, 1970. Amended: tive Sept. 1, 1989. Amended: Filed June 30, “(H) Renal dialysis. Filed Feb. 16, 1971, effective Feb. 26, 1971. 1989, effective Oct. 1, 1989. Amended: Filed “Such term also does not include any such Amended: Filed Jan. 3, 1973, effective Jan. Nov. 15, 1989, effective Feb. 1, 1990. drug or product for which a National Drug 13, 1973. Amended: Filed Feb. 6, 1975, Amended: Filed Feb. 16, 1990, effective May Code number is not required by the Food and effective Feb. 16, 1975. Amended: Filed 1, 1990. Amended: April 18, 1990, effective Drug Administration or a drug or biological March 9, 1977, effective June 11, 1977. June 30, 1990. Amended: Filed Aug. 10, used for a medical indication which is not a Amended: Filed June 13, 1977, effective Oct. 1990, effective Dec. 31, 1990. Emergency medically accepted indication.” 1, 1977. Amended: Filed March 13, 1978, amendment filed Dec. 21, 1990, effective Jan. effective June 11, 1978. Amended: Filed Feb. 1, 1991, expired April 30, 1991. Emergency (2) Participating Manufacturers—The Mis- 1, 1979, effective May 11, 1979. Emergency rescission and rule filed March 21, 1991, souri Division of Medical Services identifies amendment filed July 26, 1979, effective Aug. effective March 31, 1991, expired July 28, those manufacturers whose products are 1, 1979, expired Oct. 10, 1979. Amended: 1991. Emergency rescission filed April 2, reimbursable along with effective dates of Filed July 16, 1979, effective Oct. 11, 1979. 1991, effective April 12, 1991, expired Aug. 9, coverage, based on date of service, corre- Emergency amendment filed Aug. 11, 1981, 1991. Emergency rule filed April 2, 1991, sponding to effective dates of their participa- effective Aug. 21, 1981, expired Nov. 11, effective April 13, 1991, expired Aug. 10, tion under the national rebate contract. All 1981. Amended: Filed Aug. 11, 1981, effec- 1991. Emergency amendment filed June 21, products marketed by participating manufac- tive Nov. 12, 1981. Emergency amendment 1991, effective July 1, 1991, expired Aug. 10, turers are reimbursable, with the following filed Dec. 21, 1981, effective Jan. 1, 1982, 1991. Emergency rescission filed July 31,

JOHN R. ASHCROFT (8/31/18) CODE OF STATE REGULATIONS 3 Secretary of State 13 CSR 70-20—DEPARTMENT OF SOCIAL SERVICES Division 70—MO HealthNet Division

1991, effective Aug. 11, 1991, expired Dec. 6, states may exclude or otherwise restrict cover- MO HealthNet Pharmacy Program. 1991. Rescinded: Filed March 21, 1991, age of certain covered outpatient drugs. effective Sept. 30, 1991. Emergency rule filed Section 1927(d)(2) of the Social Security Act PUBLISHER’S NOTE: The secretary of state July 31, 1991, effective Aug. 11, 1991, expired provides a listing of the categories of drugs that has determined that the publication of the Dec. 7, 1991. Readopted: Filed July 15, are permissible for exclusion. Drugs included entire text of the material which is incorpo- 1991, effective Jan. 13, 1992. Emergency on this list may be excluded from coverage rated by reference as a portion of this rule amendment filed Sept. 23, 1991, effective entirely or restricted by diagnosis as deter- would be unduly cumbersome or expensive. Oct. 3, 1991, expired Dec. 7, 1991. mined by the state. This material as incorporated by reference in Emergency rule filed Nov. 27, 1991, effective this rule shall be maintained by the agency at Dec. 8, 1991, expired April 5, 1992. (2) As specified in Section 1927(d)(1) of the its headquarters and shall be made available Emergency amendment filed March 24, 1992, Social Security Act, states may subject to to the public for inspection and copying at no effective April 1, 1992, expired July 29, prior authorization any covered outpatient more than the actual cost of reproduction. 1992. Emergency amendment filed June 16, drug. Any such prior authorization program This note applies only to the reference mate- 1992, effective July 1, 1992, expired Oct. 28, shall comply with the requirements of Section rial. The entire text of the rule is printed 1992. Amended: Filed March 24, 1992, 1927(d)(5) of the Social Security Act. here. effective Sept. 6, 1992. Emergency amend- ment filed Sept. 21, 1992, effective Oct. 1, (3) List of drugs or categories of excludable (1) Permissible Exclusions—As specified in 1992, expired Jan. 28, 1993. Emergency drugs which are restricted to require prior the Social Security Act, Section 1927(d)(1)(B), amendment filed Jan. 15, 1993, effective Jan. authorization for certain specified indications states may exclude or otherwise restrict cover- 29, 1993, expired May 28, 1993. Amended: shall be made available through the Department age of certain covered outpatient drugs. Filed June 16, 1992, effective April 8, 1993. of Social Services, MO HealthNet Division Section 1927(d)(2) of the Social Security Act Emergency amendment filed March 19, 1993, website at dss.mo.gov/mhd, provider bulletins, provides a listing of the categories of drugs that effective April 1, 1993, expired July 29, and updates to the provider manual which are are permissible for exclusion. 1993. Emergency amendment filed June 18, incorporated by reference and made a part of 1993, effective July 1, 1993, expired Oct. 28, this rule as published by the Department of (2) List of drugs or classes which are exclud- 1993. Amended: Filed April 6, 1993, effec- Social Services, MO HealthNet Division, ed from reimbursement through the MO tive Dec. 9, 1993. Rescinded and readopted: 615 Howerton Court, Jefferson City, MO HealthNet Pharmacy Program shall be made Filed Oct. 15, 1993, effective June 6, 1994. 65109, at its website, October 15, 2013. This available through the Department of Social Amended: Filed June 29, 2000, effective Dec. rule does not incorporate any subsequent Services, MO HealthNet Division website at 30, 2000. amendments or additions. The division dss.mo.gov/mhd/index/htm, provider bul- reserves the right to affect changes in the list of letins, and updates to the provider manual *Original authority: 208.152, RSMo 1967, amended excludable drugs for which prior authorization which are incorporated by reference and 1969, 1971, 1972, 1973, 1975, 1977, 1978, 1981, 1986, is required by amending this rule. made a part of this rule as published by the 1988, 1990, 1992, 1993; 208.153, RSMo 1967, amended Department of Social Services, MO 1973, 1989, 1990, 1991 and 208.201, RSMo 1987. AUTHORITY: sections 208.153 and 208.201, HealthNet Division, 615 Howerton Court, RSMo Supp. 2013.* Original rule filed Dec. Jefferson City, MO 65109, at its website, 13, 1991, effective Aug. 6, 1992. Amended: 13 CSR 70-20.031 List of Excludable October 15, 2013. This rule does not incor- Filed May 15, 1992, effective Jan. 15, 1993. porate any subsequent amendments or addi- Drugs for Which Prior Authorization Is Amended: Filed March 1, 1996, effective Required tions. The division reserves the right to affect Oct. 30, 1996. Amended: Filed May 27, changes in the list of excluded drugs by 1999, effective Dec. 30, 1999. Emergency amending this rule. PURPOSE: This rule establishes a listing of amendment filed Nov. 21, 2000, effective excludable drugs and categories of drugs for Dec. 1, 2000, expired May 29, 2001. AUTHORITY: sections 208.153 and 208.201, which prior authorization is required in order Amended: Filed June 29, 2000, effective Feb. RSMo Supp. 2013.* Original rule filed Dec. for them to be reimbursable under the MO 28, 2001. Emergency amendment filed June 13, 1991, effective Aug. 6, 1992. Amended: HealthNet Pharmacy Program. 7, 2002, effective July 1, 2002, expired Dec. Filed June 30, 2000, effective Feb. 28, 2001. 27, 2002. Amended: Filed June 11, 2002, PUBLISHER’S NOTE: The secretary of state effective Jan. 30, 2003. Amended: Filed Jan. Emergency amendment filed June 7, 2002, has determined that the publication of the 16, 2007, effective July 30, 2007. Amended: effective July 1, 2002, expired Dec. 27, 2002. entire text of the material which is incorpo- Filed Sept. 16, 2013, effective March 30, Amended: Filed June 11, 2002, effective Jan. rated by reference as a portion of this rule 2014. 30, 2003. Amended: Filed Jan. 16, 2007, would be unduly cumbersome or expensive. effective July 30, 2007. Amended: Filed Sept. This material as incorporated by reference in *Original authority: 208.153, RSMo 1967, amended 16, 2013, effective March 30, 2014. 1967, 1973, 1989, 1990, 1991, 2007, 2012 and 208.201, this rule shall be maintained by the agency at RSMo 1987, amended 2007. *Original authority: 208.153, RSMo 1967, amended its headquarters and shall be made available 1967, 1973, 1989, 1990, 1991, 2007, 2012 and 208.201, to the public for inspection and copying at no RSMo 1987, amended 2007. more than the actual cost of reproduction. 13 CSR 70-20.032 List of Excludable Drugs This note applies only to the reference mate- Excluded From Coverage Under the MO rial. The entire text of the rule is printed HealthNet Pharmacy Program 13 CSR 70-20.033 Medicaid Program here. Coverage of Investigational Drugs Used in PURPOSE: This rule establishes a listing of the Treatment of Acquired Immunodefi- (1) Permissible Exclusions—As specified in excludable drugs or categories for which ciency Syndrome (AIDS) the Social Security Act, Section 1927(d)(1)(B), reimbursement is not available through the (Rescinded September 30, 2018)

4 CODE OF STATE REGULATIONS (8/31/18) JOHN R. ASHCROFT Secretary of State Chapter 20—Pharmacy Program 13 CSR 70-20

AUTHORITY: sections 208.152, 208.153 and Amended: Filed June 11, 2002, effective Jan. Carbamazepine 208.201, RSMo 1994. Emergency rule filed 30, 2003. Amended: Filed Jan. 16, 2007, Carbidopa and Levodopa Dec. 15, 1995, effective Jan. 1, 1996, effective July 30, 2007. Amended: Filed Aug. Chlorothiazide expired June 28, 1996. Original rule filed 17, 2009, effective Feb. 28, 2010. Chlorpropamide Tablets Dec. 15, 1995, effective July 30, 1996. Chlorthalidone and Clonidine HCl *Original authority: 208.152, RSMo 1967, amended Rescinded: Filed March 2, 2018, effective 1969, 1971, 1972, 1973, 1975, 1977, 1978, 1978, 1981, Chlorthalidone Tablets Sept. 30, 2018. 1986, 1988, 1990, 1992, 1993, 2004, 2005, 2007; Cholestyramine 208.153, RSMo 1967, amended 1967, 1973, 1989, 1990, Clofibrate 1991, 2007; and 208.201, RSMo 1987, amended 2007. Clonazepam 13 CSR 70-20.034 List of Non-Excludable Clonidine HCl Drugs for Which Prior Authorization Is Clonidine Transdermal Systems 13 CSR 70-20.040 Five Prescription Limit Required Codeine Phosphate, Ephedrine Sulfate Per Month Per Recipient and Guaifenesin Syrup PURPOSE: This rule establishes a listing of Colestipol HCl non-excludable drugs and categories of drugs PURPOSE: This rule imposes a limitation on Cromolyn Sodium for which prior authorization is required in the number of prescriptions which may be Demecarium Bromide Ophthalmic order for them to be reimbursable under the covered services within a specified time peri- MO HealthNet Pharmacy Program. od for each recipient. Solution Deserpidine and Methyclothiazide PUBLISHER’S NOTE: The secretary of state (1) The number of prescriptions which may Dexamethasone Sodium Phosphate has determined that the publication of the be filled or refilled will be limited to five (5) Nasal Inhaler entire text of the material which is incorpo- per recipient during any one (1) period of eli- Dexamethasone Sodium Phosphate Oral rated by reference as a portion of this rule gibility which does not exceed the normal Inhaler would be unduly cumbersome or expensive. monthly eligibility span for the recipient’s Dichlorphenamide Tablets This material as incorporated by reference in assistance category involved. Dicumarol Tablets this rule shall be maintained by the agency at (A) The only allowable exception to the Diflunisal its headquarters and shall be made available five (5)-prescription limitation will be for Digitalis to the public for inspection and copying at no certain specified drugs which are commonly Digitoxin Tablets more than the actual cost of reproduction. prescribed for long-term chronic medical Digoxin This note applies only to the reference mate- conditions and for prior authorized drugs. Diltiazem HCl rial. The entire text of the rule is printed (B) These listed drugs shall be considered Diltiazem HCl Sustained Release here. to be used for the treatment of long-term Capsules chronic medical conditions and shall there- Dipivefrin HCl Ophthalmic Solution (1) As specified in section 1927(d)(1) of the fore be exempted from the prescription limi- Dipyridamole Social Security Act, states may subject to tation. Disopyramide prior authorization any covered outpatient Disopyramide Sustained Release drug. Any such prior authorization program Acebutolol HCl Capsules shall comply with the requirements of section Acetazolamide 1927(d)(5) of the Social Security Act. Acetohexamide Dyphylline Albuterol Dyphylline and Guaifenesin (2) List of drugs or categories of drugs which Albuterol Sustained Release Tablets Echothiophate Iodide Ophthalmic are restricted to require prior authorization Amantadine HCl Solution for certain specified indications shall be made Amiloride HCl and Hydrochlorothiazide Enalapril Maleate available through the Department of Social Tablets Enalapril Maleate and Hydrochlorothiazide Services, MO HealthNet Division website at Amiloride HCl Tablets Encainide HCl www.dss.mo.gov/mhd, provider bulletins, Aminophylline Ephedrine Sulfate Capsules and updates to the provider manual which are Anhydrous Calcium Iodide and Ephedrine Sulfate Syrup incorporated by reference and made a part of Isoproternal Sulfate Syrup Ephedrine Sulfate and Guaifenesin this rule as published by the Department of Atenolol and Chlorthalidone Tablets Epinephrine Ophthalmic Solution Social Services, MO HealthNet Division, Atenolol Tablets Ergoloid Mesylates Sublingual 615 Howerton Court, Jefferson City, MO Beclomethasone Dipropionate Ethacrynic Acid 65109, at its website, September 15, 2009. Bendroflumethiazide Ethosuximide This rule does not incorporate any subse- Bendroflumethiazide and Nadolol Flecainide quent amendments or additions. The division Tablets Flunisolide Nasal Spray reserves the right to affect changes in prior Benztropine Mesylate Flunisolide Oral Inhaler authorization of non-excludable drugs by Betaxolol HCl Ophthalmic Solution Furosemide amending this rule. Bethanechol Chloride Gemfibrozil AUTHORITY: sections 208.152, 208.153, Biperiden Tablets Glipizide and 208.201, RSMo Supp. 2008.* Emergency Bitolterol Mesylate Glyburide rule filed Nov. 21, 2000, effective Dec. 1, Bumetanide Tablets Guaifenesin and Oxtriphylline Tablets 2000, expired May 29, 2001. Original rule Captopril and Hydrochlorothiazide Guaifenesin and Phenylpropanolamine filed June 29, 2000, effective Feb. 28, 2001. Tablets HCl Sustained Release Tablets Emergency amendment filed June 7, 2002, Captopril Tablets Guaifenesin and Theophylline Sodium effective July 1, 2002, expired Dec. 27, 2002. Carbachol Ophthalmic Solution Glycinate Tablets

JOHN R. ASHCROFT (10/31/18) CODE OF STATE REGULATIONS 5 Secretary of State 13 CSR 70-20—DEPARTMENT OF SOCIAL SERVICES Division 70—MO HealthNet Division

Guaifenesin and Pseudoephedrine HCl Nadolol Tablets Verapamil HCl Sustained Release Tablets Niacin Tablets Verapamil HCl Sustained Release Guaifenesin and Theophylline Capsules Nicardipine HCl Tablets Guaifenesin and Theophylline Tablets Nifedipine Capsules Warfarin Sodium Tablets Guanabenz Acetate Tablets Nifedipine Controlled Release Tablets Guanadrel Sulfate Tablets Nitroglycerin Spray AUTHORITY: sections 208.153, RSMo Supp. Guanethidine Monosulfate and Nitroglycerin Sublingual Tablets 1991 and 208.201, RSMo Supp. 1987.* This Hydrochlorothiazide Tablets Nitroglycerin Sustained Release rule was previously filed as 13 CSR 40- Guanethidine Monosulfate Tablets Capsules 81.012. Emergency rule filed Oct. 21, 1981, Guanfacine HCl Nitroglycerin Topical Ointment effective Nov. 1, 1981, expired Feb. 10, 1982. Hydralazine Nitroglycerin Transdermal Systems Original rule filed Oct. 21, 1981, effective Hydralazine and Hydrochlorothiazide Oxtriphylline Feb. 11, 1982. Amended: Filed March 14, Hydralazine, Hydrochlorothiazide and Papaverine HCl Sustained Release 1984, effective June 11, 1984. Amended: Reserpine 150 mg. Filed June 12, 1984, effective Sept. 14, 1984. Hydrochlorothiazide and Lisinopril Pentoxifylline Amended: Filed Jan. 15, 1985, effective April Hydrochlorothiazide and Methyldopa Phenobarbital 11, 1985. Amended: Filed April 16, 1985, Tablets Phenytoin effective July 11, 1985. Amended: Filed Oct. Hydrochlorothiazide and Metoprolol Pilocarpine HCl Ophthalmic Solution 2, 1985, effective Jan. 1, 1986. Amended: Tartrate Pindolol Filed April 16, 1986, effective July 1, 1986. Hydrochlorothiazide and Spironolactone Pirbuterol Acetate Emergency amendment filed Dec. 18, 1986, Tablets Polythiazide effective Jan. 1, 1987, expired Feb. 11, 1987. Hydrochlorothiazide and Timolol Potassium Chloride Capsules Amended: Filed Sept. 17, 1986, effective Hydrochlorothiazide and Triamterene Potassium Chloride 10% Liquid Dec. 1, 1986. Amended: Filed Nov. 14, 1986, Hydrochlorothiazide Tablets Potassium Chloride 20% Liquid effective Feb. 12, 1987. Amended: Filed Feb. Hydrochlorothiazide with Labetalol Potassium Chloride Oral Tablets 18, 1987, effective May 1, 1987. Emergency Hydroflumethiazide and Reserpine Potassium Chloride Sustained Release amendment filed Dec. 18, 1986, effective Indapamide Tablets Capsules Jan. 1, 1987, expired Feb. 11, 1987. Indomethacin Suppositories Potassium Chloride Sustained Release Amended: Filed April 17, 1987, effective July Insulin Tablets 1, 1987. Amended: Filed June 16, 1987, Intravenous Fluids Prazosin HCl effective Sept. 1, 1987. Amended: Filed Aug. Dextrose 25%, Sodium Chloride 0.45% Primidone 18, 1987, effective Nov. 12, 1987. Amended: Dextrose 5% Probucol Filed Dec. 1, 1987, effective Feb. 11, 1988. Dextrose 5%, Lactated Ringer’s Procainamide HCl Capsules Amended: Filed April 15, 1988, effective July Dextrose 5%, Sodium Chloride 0.225% Procyclidine 1, 1988. Amended: Filed July 15, 1988, Dextrose 5%, Sodium Chloride 0.3% Propranolol HCl Sustained Release effective Oct. 13, 1988. Amended: Filed July Dextrose 5%, Sodium Chloride 0.45% Capsules 15, 1988, effective Oct. 13, 1988. Amended: Dextrose 5%, Sodium Chloride 0.9% Propranolol HCl Tablets Filed Sept. 15, 1988, effective Dec. 11, 1988. Lactated Ringer’s Propylthiouracil Amended: Filed April 4, 1989, effective July Sodium Chloride 0.45% Quinethazone Tablets 1, 1989. Amended: Filed June 6, 1989, effec- Sodium Chloride 0.9% Quinidine Sulfate Tablets tive Sept. 1, 1989. Amended: Filed June 30, Ipatropium Bromide Rauwolfia Serpentina Tablets 1989, effective Oct. 1, 1989. Amended: Filed Isoetharine HCl Reserpine and Trichlormethiazide Nov. 15, 1989, effective Feb. 1, 1990. Isoflurophate Ophthalmic Reserpine Tablets Amended: Filed Aug. 13, 1990, effective Dec. Isoproterenol Spironolactone 31, 1990. Emergency amendment filed Dec. Isoproterenol and Phenylephrine Syringes, Disposable, Insulin 21, 1990, effective Jan. 1, 1991, expired Bitartrate Oral Inhaler Terazosin HCl April 30, 1991. Emergency amendment filed Isosorbide Dinitrate Terbutaline Sulfate March 21, 1991, effective April 1, 1991, Labetalol Theophylline expired July 29, 1991. Amended: Filed March Levobunolol HCl Ophthalmic Solution Theophylline Sustained Release 13, 1991, effective Oct. 31, 1991. Levodopa Capsules *Original authority: 208.153, RSMo 1967, amended Levothyroxine Sodium Theophylline Sustained Release 1973, 1989, 1990, 1991 and 208.201, RSMo 1987. Lisinopril Tablets Lovastatin Thyroid Tablets Mecamylamine HCl Timolol Maleate 13 CSR 70-20.045 Thirty-One Day Supply Metaproterenol Sulfate Tocainide Maximum Restriction on Pharmacy Methazolamide Tablets Tolazamide Tablets Services Reimbursed by the MO HealthNet Methyclothiazide Tolbutamide Division Methyldopa Triamcinolone Acetonide Oral Inhaler Metolazone Trichlormethiazide PURPOSE: This rule establishes a thirty-one Metoprolol Tartrate Trihexyphenidyl (31) day supply maximum restriction per dis- Metyrosine Valproic Acid pensing on pharmacy services reimbursed by Mexiletine HCl Valproic Acid, E.C. the MO HealthNet Division on behalf of

6 CODE OF STATE REGULATIONS (10/31/18) JOHN R. ASHCROFT Secretary of State Chapter 20—Pharmacy Program 13 CSR 70-20

patients eligible for any of the fee-for-service effective Nov. 30, 2018. 13 CSR 70-20.060 Professional Dispensing programs. Fee *Original authority: 208.152, RSMo 1967, amended PUBLISHER’S NOTE: The secretary of state 1969, 1971, 1972, 1973, 1975, 1977, 1978, 1978, 1981, PURPOSE: The MO HealthNet Division 1986, 1988, 1990, 1992, 1993, 2004, 2005, 2007, 2011, has determined that the publication of the 2013, 2014, 2015, 2016, 2018; 208.153, RSMo 1967, establishes the amount of the fee reim- entire text of the material which is incorporat- amended 1973, 1989, 1990, 1991, 2007, 2012; 208.201, bursable for the professional dispensing of ed by reference as a portion of this rule would RSMo 1987, amended 2007; and 660.017, RSMo 1993, each MO HealthNet covered prescription by a be unduly cumbersome or expensive. This amended 1995. pharmacy provider, raises the current dis- material as incorporated by reference in this pensing fee from three dollars ($3) to four rule shall be maintained by the agency at its dollars eighty-four cents ($4.84) and estab- 13 CSR 70-20.050 Return of Drugs headquarters and shall be made available to lishes a long-term care prescription fee add- the public for inspection and copying at no on of fifteen cents (15¢). more than the actual cost of reproduction. PURPOSE: This rule establishes that when a This note applies only to the reference mater- pharmacy dispenses drugs in a controlled- PUBLISHER’S NOTE: The secretary of state ial. The entire text of the rule is printed here. dose delivery system, the pharmacy must give the MO HealthNet Division credit for any has determined that the publication of the (1) The maximum days supply of medication unused portion of the drug that is reusable in entire text of the material which is incorpo- which may be provided per dispensing on accordance with applicable federal or state rated by reference as a portion of this rule behalf of a patient eligible for any of the fee- law. would be unduly cumbersome or expensive. for-service programs is thirty-one (31) day Therefore, the material which is so incorpo- supply, except for those drugs and/or cate- (1) Definitions. rated is on file with the agency who filed this gories under the provisions of this rule. (A) Controlled-dose delivery system. A rule, and with the Office of the Secretary of Medication may be dispensed in quantities controlled-dose delivery system is defined as a State. Any interested person may view this less than a thirty-one (31) day supply, if so system of dispensing of medications on behalf material at either agency’s headquarters or ordered by the prescriber, except as specified of a resident in a long-term care facility in the same will be made available at the Office elsewhere in this rule. manufacturer’s unit dose packaging or phar- of the Secretary of State at a cost not to macist packager’s unit dose, unit-of-use, or exceed actual cost of copy reproduction. The (2) Drugs and/or categories of medications strip packaging with each tablet or capsule entire text of the rule is printed here. This which are exempt from the thirty-one (31) individually wrapped, or in blister cards, all note refers only to the incorporated by refer- day supply limitation and therefore may be of which must be dispensed according to ence material. dispensed in quantities exceeding a thirty-one applicable state and federal laws or regula- (31) day supply are made available in the MO tions. (1) A dispensing fee of four dollars eighty- HealthNet Pharmacy Manual, section four cents ($4.84) shall be added to the MO 13.6.D(1), located through the Department of (2) The return and reuse of drugs must follow Social Services, MO HealthNet Division web- HealthNet maximum allowable payment for guidelines set by the State Board of Pharmacy each MO HealthNet reimbursable prescrip- site at manuals.momed.com/manuals, which in 20 CSR 2220-3.040, as amended. is incorporated by reference and made part of tion filled or refilled by a pharmacy provider. (A) The professional dispensing fees as this rule as published by the Department of (3) When a pharmacy dispenses drugs in a provided in this rule shall not be included in Social Services, MO HealthNet Division, 615 controlled-dose delivery system the pharmacy the computation of the MO HealthNet maxi- Howerton Court, Jefferson City, MO 65109, must give the MO HealthNet Division credit mum allowable drug payment for participant at its website, April 18, 2018. This rule does for all reusable items (any unused portion) not not incorporate any subsequent amendments taken by the MO HealthNet participant. In cost-sharing purposes. or additions. The division reserves the right to instances in which charges have been submit- affect changes in the list of drugs and/or cate- ted prior to the return of an item the pharmacy (2) All pharmacy providers supplying pre- gories of medications which are exempt from shall file an adjustment to notify the scribed MO HealthNet covered drugs to par- the thirty-one (31) day supply limitation by MO HealthNet Division of the need to process ticipants in long-term care facilities shall ¢ amending this rule. a credit. The dispensing pharmacy that receive an additional fifteen cent (15 ) dis- receives the returned drugs must provide a pensing fee per claim provided they— (3) All spend down recipients are exempt from credit to the MO HealthNet Division for the (A) Dispense medication in a drug distrib- the MO HealthNet thirty-one (31) day supply amount reimbursed for drug costs from which ution system(s) which meets minimum stan- maximum restriction on pharmacy services. the prescription was billed, prorated to the dards of container packaging (at least class B quantity of the drug returned. The credited as defined in United States Pharmacopeia (4) Exemptions from the thirty-one (31) day amount should not include dispensing fees. XXI); supply limitation may be given with prior (B) Certify to the MO HealthNet Division, authorization by the MO HealthNet Division to prevent a higher level of care. AUTHORITY: sections 208.153, 208.201, on a form, and in the manner prescribed by and 660.017, RSMo 2016.* Original rule the division, that they— AUTHORITY: sections 208.153, 208.201, filed Dec. 15, 2000, effective July 30, 2001. 1. Provide this dispensing service to and 660.017, RSMo 2016, and section Amended: Filed Sept. 16, 2013, effective their long-term care facility resident patients; 208.152, RSMo Supp. 2018.* Emergency rule March 30, 2014. Amended: Filed April 18, 2. Provide emergency services twenty- filed Nov. 21, 2000, effective Dec. 1, 2000, 2018, effective Nov. 30, 2018. four (24) hours a day with seven (7) days a expired May 29, 2001. Original rule filed week availability; and June 29, 2000, effective Feb. 28, 2001. *Original authority: 208.153, RSMo 1967, amended 3. Have ability and willingness to assist 1973, 1989, 1990, 1991, 2007, 2012; 208.201, RSMo Amended: Filed Dec. 5, 2000, effective June 1987, amended 2007; and 660.017, RSMo 1993, amended in accessing medications through the 30, 2001. Amended: Filed April 18, 2018, 1995. MO HealthNet Exception Process; and

JOHN R. ASHCROFT (10/31/18) CODE OF STATE REGULATIONS 7 Secretary of State 13 CSR 70-20—DEPARTMENT OF SOCIAL SERVICES Division 70—MO HealthNet Division

(C) Indicate, as prescribed by the MO add the Missouri Maximum Allowable Cost March 6, 1988. Original rule filed Dec. 1, HealthNet Division, on each claim that the (MMAC) limits, for multiple source drugs as 1987, effective Feb. 11, 1988. Emergency prescription was provided in packaging qual- defined, to the data shown on the tape amendment filed June 21, 1988, effective July ifying for the dispensing fee add-on to a par- described in section (1) of this rule. 1, 1988, expired Oct. 28, 1988. Amended: ticipant in a long-term care facility. Filed Aug. 16, 1988, effective Oct. 29, 1988. (3) Reimbursement for covered drugs will be Emergency amendment filed May 12, 1989, AUTHORITY: sections 208.153 and 208.201, made at the lower of the— effective June 1, 1989, expired Sept. 23, RSMo Supp. 2013.* Original rule filed Dec. (A) Usual and customary charge as billed 1989. Amended: Filed May 12, 1989, effec- 15, 1987, effective March 11, 1988. by the provider; or tive Aug. 11, 1989. Amended: Filed Nov. 15, Amended: Filed Sept. 26, 2013, effective (B) Price(s) included on the Drug Pricing 1989, effective Feb. 1, 1990. Amended: Filed March 30, 2014. File which is derived from one (1) or more of April 18, 1990, effective June 30, 1990. *Original authority: 208.153, RSMo 1967, amended the following: Emergency amendment filed Aug. 20, 1990, 1973, 1989, 1990, 1991, 2007, 2012 and 208.201, RSMo 1. The AWP as furnished by the state’s effective Sept. 1, 1990, expired Dec. 30, 1987, amended 2007. contracted agent, less ten and forty-three 1990. Amended: Filed Sept. 5, 1990, effec- hundredths percent (10.43%); tive Feb. 14, 1991. Emergency amendment 2. The MMAC as determined by the filed Dec. 20, 1990, effective Dec. 31, 1990, 13 CSR 70-20.070 Computer-Generated state agency for selected multiple source expired April 29, 1991. Emergency amend- Drug Pricing Tape and Drug Reimburse- drugs; ment filed March 21, 1991, effective March ment Methodology 3. Applicable federal upper limits as 31, 1991, expired July 28, 1991. Amended: found at www.dss.state.mo.us/dms; or Filed April 2, 1991, effective Oct. 31, 1991. PURPOSE: This rule establishes the basis 4. The WAC as furnished by the state’s and the method for pricing all drug claims in Emergency amendment filed Dec. 4, 1992, contracted agent, plus ten percent (10%). Missouri under the Title XIX Medicaid pro- effective Dec. 15, 1992, expired April 13, gram. The purchase of a computer-generated 1993. Emergency rescission and emergency AUTHORITY: sections 208.152, 208.153, tape, with weekly updates, will make it possi- rule filed April 2, 1993, effective April 13, and 208.201, RSMo 2000.* This rule was ble to utilize the computer for review purpos- 1993, expired Aug. 10, 1993. Amended: Filed previously filed as 13 CSR 40-81.150. es, which greatly increases the speed with Aug. 27, 1993, effective May 9, 1994. which claims can be paid. Original rule filed April 23, 1979, effective Amended: Filed Sept. 26, 2013, effective Aug. 11, 1979. Emergency amendment filed March 30, 2014. Rescinded: Filed March 2, PUBLISHER’S NOTE: The publication of the Sept. 9, 1981, effective Oct. 1, 1981, expired 2018, effective Sept. 30, 2018. full text of the material that the adopting Dec. 10, 1981. Amended: Filed Sept. 9, 1981, agency has incorporated by reference in this effective Dec. 11, 1981. Emergency amend- 13 CSR 70-20.080 Labeling of Medicaid rule would be unduly cumbersome or expen- ment filed Oct. 19, 1987, effective Oct. 29, Prescriptions sive. Therefore, the full text of that material 1987, expired Feb. 25, 1988. Amended: Filed (Rescinded December 9, 1993) will be made available to any interested per- Dec. 1, 1987, effective Feb. 11, 1988. son at both the Office of the Secretary of State Emergency amendment filed March 29, 1988, AUTHORITY: sections 207.020, RSMo 1986 and the office of the adopting agency, pur- effective April 8, 1988, expired Aug. 5, 1988. and 208.153, RSMo Supp. 1991. This rule suant to section 536.031.4, RSMo. Such Amended: Filed May 3, 1988, effective July was previously filed as 13 CSR 40-81.030. material will be provided at the cost estab- 28, 1988. Emergency amendment filed Dec. Original rule file Oct. 24, 1974, effective lished by state law. 21, 1990, effective March 17, 1991, expired Nov. 3, 1974. Rescinded: Filed April 6, 1993, April 30, 1991. Emergency amendment filed effective Dec. 9, 1993. (1) The Division of Medical Services will March 6, 1991, effective March 17, 1991, obtain, by contract with a reputable medical expired July 14, 1991. Emergency amendment publishing company, a weekly computer-gen- filed Sept. 4, 1991, effective Sept. 17, 1991, 13 CSR 70-20.100 Missouri Nonsteroidal erated tape which will provide the informa- expired Jan. 14, 1992. Amended: Filed Sept. Anti-Inflammatory Drug List tion needed to price all fee-for-service 4, 1991, effective Jan. 13, 1992. Amended: (Rescinded September 30, 1991) Medicaid drug claims. The tape will contain Filed Dec. 5, 2000, effective June 30, 2001. AUTHORITY: sections 208.153 and 208.201, National Drug Code (NDC), drug name, RSMo Supp. 1989. This rule was previously drug strength, dosage form, package size, the *Original authority: 208.152, RSMo 1967, amended filed as 13 CSR 40-81.013. Original rule filed Average Wholesale Price (AWP), the prices 1969, 1971, 1972, 1973, 1975, 1977, 1978, 1981, 1986, 1988, 1990, 1992, 1993; 208.153, RSMo 1967, amended Feb. 18, 1987, effective June 1, 1987. set by direct-selling manufacturers (direct 1973, 1989, 1990, 1991; and 208.201, RSMo 1987. Amended: Filed April 4, 1989, effective July prices), Wholesaler Acquisition Cost (WAC), 1, 1989. Amended: Filed Aug. 13, 1990, and federal Health and Human Services effective Dec. 31, 1990. Emergency rescission upper limits for specified multiple source 13 CSR 70-20.071 Multiple Source Drugs filed March 21, 1991, effective March 31, drugs. A multiple source drug is defined as a for Which There Exists a Federal Upper 1991, expired July 28, 1991. Rescinded: Filed drug marketed or sold by two (2) or more Limit on Reimbursement March 21, 1991, effective Sept. 30, 1991. manufacturers or labelers, or a drug market- (Rescinded September 30, 2018) ed or sold by the same manufacturer or label- er under two (2) or more different proprietary AUTHORITY: sections 208.153 and 208.201, 13 CSR 70-20.110 Medicaid Program names or both under a proprietary name and RSMo Supp. 2013. Emergency rule filed Oct. Coverage of Approved Drugs for Treat- without that name. 19, 1987, effective Oct. 29, 1987, expired ment of Acquired Immunodeficiency Syn- Feb. 25, 1988. Emergency amendment filed drome (AIDS) (2) The Division of Medical Services will Oct. 29, 1987, effective Nov. 8, 1987, expired (Rescinded September 30, 1991)

8 CODE OF STATE REGULATIONS (10/31/18) JOHN R. ASHCROFT Secretary of State Chapter 20—Pharmacy Program 13 CSR 70-20

AUTHORITY: sections 208.153, RSMo 1986 process that specifies the sequence in which (B) The United States Pharmacopoeia and 208.201, RSMo Supp. 1988. Emergency different prescription drugs are to be reim- Drug Information; and rule filed July 9, 1987, effective July 19, bursed. (C) Peer-reviewed medical literature. 1987, expired Nov. 15, 1987. Original rule (F) “Utilization edits” are defined as filed July 31, 1987, effective Nov. 12, 1987. prospective screening edits used to review the (5) If the division finds that the data enumer- Amended: Filed Nov. 15, 1989, effective Feb. appropriate use of medication and may be ated in section (4) of this rule has been doc- 1, 1990. Emergency rescission filed March advisory or preemptory. umented, the MO HealthNet Drug Prior 21, 1991, effective March 31, 1991, expired Authorization Committee shall hold a public July 28, 1991. Rescinded: Filed March 21, (2) This rule establishes a MO HealthNet hearing prior to making recommendations to 1991, effective Sept. 30, 1991. Drug Prior Authorization Committee in the the department and prior to any final decision Department of Social Services, MO by the division to require prior authorization HealthNet Division. The committee shall be for that pharmaceutical product, class, or cat- 13 CSR 70-20.120 Medicaid Program composed of three (3) practicing physicians egory. Coverage of Anti-Ulcer Preparations licensed pursuant to Chapter 334, RSMo; (Rescinded June 29, 1989) three (3) practicing pharmacists licensed pur- (6) The tentative meeting agenda of the MO AUTHORITY: sections 208.153, RSMo 1986 suant to Chapter 338, RSMo, one (1) of HealthNet Drug Prior Authorization Commit- and 208.201, RSMo Supp. 1987. Original whom shall hold a doctoral degree in phar- tee with the classes to be discussed shall be rule filed Oct. 18, 1988, effective Jan. 1, macy (Pharm. D.); and one (1) registered posted on the MO HealthNet Division website 1989. Amended: Filed March 16, 1989. professional nurse, as defined in Chapter (www.dss.mo.gov/mhd) approximately four- Emergency rescission filed April 7, 1989, 335, RSMo, practicing in a long-term care teen (14) days prior but no less than seven (7) effective April 20, 1989, expired Aug. 17, setting. All members shall be appointed by days prior to the meeting. 1989. Rescinded: Filed April 7, 1989, effec- the director of the Department of Social (A) The specific therapeutic class or class- tive June 29, 1989. Services. The members shall serve for a term es to be considered at the next regularly of four (4) years. Members of the committee scheduled MO HealthNet Drug Prior shall receive no compensation for their ser- Authorization Committee meeting shall be 13 CSR 70-20.200 Drug Prior Authoriza- vices, but shall be reimbursed for their actual placed on the current agenda or posted on the tion Process and necessary expenses incurred, as approved website approximately thirty (30) days prior by the MO HealthNet Division out of appro- to the scheduled meeting. PURPOSE: This rule establishes the division priations made for that purpose. The MO (B) Any interested party shall be granted process by which drugs may be restricted HealthNet Drug Prior Authorization the opportunity for clinically relevant public under Section 4401 of P.L. 101-508 (Omnibus Committee shall meet quarterly. The pro- comment for up to fifteen (15) minutes in the Budget Reconciliation Act of 1990) and are posed dates for the meetings shall be aggregate per medication under review by the determined to be appropriate for inclusion as announced for one (1) calendar year at the committee. The responsibility of scheduling a regular benefit of the MO HealthNet pro- last meeting of the previous calendar year. If the presentation shall rest with the manufac- gram or through prior authorization. a meeting date is changed the new date must turer of the drug product. be posted at www.dss.mo.gov/mhd for at (C) Following the consideration of all pre- (1) The following definitions shall be used in least thirty (30) days prior to the originally sented information, the committee shall make the interpretation and enforcement of this rule: scheduled meeting. their final recommendation to the MO (A) “Clinical editing” shall be defined as HealthNet Division by a majority vote of the that process which screens the use of specific (3) All persons eligible for medical assistance members of the committee present thereto in medications on the basis of clinical appropri- benefits shall have access to all pharmaceuti- a recorded roll call vote. ateness by requiring evidence of appropriate cal products for which there is federal finan- (D) The specific therapeutic class or class- indications for use, and to achieve a cost sav- cial participation except those drugs that may es recommended for restriction by means of ings, may require the initial use of less expen- be restricted under Section 4401 of P.L. 101- step therapy, clinical edit, fiscal edit, or pre- sive agents. 508 (Omnibus Budget Reconciliation Act of ferred drug list shall be available on the divi- (B) “Fiscal editing” shall be defined as a 1990). The MO HealthNet Drug Prior sion website at www.dss.mo.gov/mhd process that screens the use of specific med- Authorization Committee shall review those approximately fifteen (15) calendar days after ications to reimburse based on the least drugs that may be restricted and recommend the meeting. expensive dosage forms in order to achieve a those appropriate for inclusion as a regular cost savings. benefit of the MO HealthNet program or (7) The recommendations from the MO (C) “Open access” shall be defined as the through prior authorization. HealthNet Drug Prior Authorization Com- availability of a product without being sub- mittee shall be referred to the Drug jected to prior authorization, clinical edits or (4) The department or the division may Utilization Review (DUR) Board for place- step therapy but shall not preclude fiscal and require prior authorization of pharmaceutical ment upon the agenda of the next regularly utilization edits. products. Any such restriction shall be based scheduled meeting. The DUR board may (D) “Preferred Drug List” shall be defined on medical and clinical criteria, and Missouri- accept or alter the recommendations from the as a list of medications within a functional specific data. The committee shall develop MO HealthNet Drug Prior Authorization therapeutic class that are available via open this medical and clinical criteria based on Committee in arriving at their recommenda- access on the basis of supplemental rebate predetermined standards consistent with the tion for the MO HealthNet Division. If pro- status and consideration of available evi- following: vided to the division fourteen (14) days in dence-based clinical review findings. (A) The American Hospital Formulary advance of the DUR board meeting, clinical- (E) “Step therapy” shall be defined as a Service Drug Information; ly relevant written material shall be presented

JOHN R. ASHCROFT (8/31/18) CODE OF STATE REGULATIONS 9 Secretary of State 13 CSR 70-20—DEPARTMENT OF SOCIAL SERVICES Division 70—MO HealthNet Division

before the recommendation is considered by Drug Efficacy Study Implementation (DESI) (3) The review referenced in section (2) shall the DUR board. The DUR board, at their drugs as designated by federal law) pursuant occur within thirty (30) business days after sole discretion, may entertain clinically rele- to this rule without consulting the Drug Prior the division receives notice through pricing vant public comment up to fifteen (15) min- Authorization Committee. The division may updates of the availability of the drug entity utes in aggregate per medication. The limit the number of prescriptions allowed for on the market. Upon completion of the responsibility of scheduling the presentation each medical assistance participant. review, the division shall make the drug avail- shall rest with the manufacturer of the drug able for use by all MO HealthNet participants product. Any changes recommended by the (11) As used in the rule, DESI drugs are or refer the new drug or new drug dosage DUR board shall be made available via the drugs described in section 107(c)(3) of the form to the MO HealthNet Drug Prior approved minutes of the DUR board meeting Drug Amendments of 1962 and identical, Authorization Committee (MDPAC) with a similar or related drugs (within the meaning in a timely fashion, at least thirty (30) days recommendation for continued prior autho- prior to the implementation of the recommen- of section 310.6(b)(1) of Title 21 of the Code of Federal Regulations). rization. Staff recommendations regarding dations. continued prior authorization of a new drug (12) When implementing the provisions of or new drug dosage form shall be made in (8) After all recommendations have been section (4), Missouri-specific data shall writing to the MDPAC. A copy shall be avail- reviewed and accepted, the MO HealthNet include the consideration of use and cost able to the public prior to the MDPAC meet- Division staff shall coordinate the implemen- data, pharmacoeconomic information and ing in which the continued prior authoriza- tation of the recommendations. All pertinent prudent utilization of state funds, and shall tion is to be discussed. information relating to edit schedule and edit include medical and clinical criteria. criteria shall be made available to the public (4) The MDPAC shall consider any recom- by reasonable means, including, but not lim- AUTHORITY: sections 208.153 and 208.201, mendations related to continued prior autho- ited to, posting on the division website in a RSMo Supp. 2013.* Original rule filed Feb. rization of a new drug or new drug dosage timely fashion following the DUR board 3, 1992, effective Aug. 6, 1992. Emergency form at the next scheduled MDPAC meeting. meeting. Changes to the MO HealthNet phar- amendment filed May 22, 2002, effective The division and the MDPAC may actively macy benefit will be posted on a timely basis June 1, 2002, expired Nov. 27, 2002. seek comments about the proposed restric- on the division website. In addition, informa- Amended: Filed June 3, 2002, effective Nov. tions. The MDPAC shall include a minimum tion on covered medications shall be made 30, 2002. Amended: Filed Dec. 14, 2004, of fifteen (15) minutes for any interested par- available to the public for use with a personal effective June 30, 2005. Amended: Filed ties who have notified the division in advance digital assistant device. As determined by the Sept. 26, 2013, effective March 30, 2014. division, patients stabilized on certain of the scheduled meeting to comment about restricted medications shall be allowed to *Original authority: 208.153, RSMo 1967, amended, such proposed restrictions. access such medication through the MO 1967, 1973, 1989, 1990, 1991, 2007, 2012 and 208.201, RSMo 1987, amended 2007. (5) If the MDPAC finds that use and cost HealthNet program for as long as the MO data, pharmacoeconomic information, along HealthNet program determines that it is fis- with medical and clinical implications of cally prudent and clinically supported. 13 CSR 70-20.250 Prior Authorization of restriction, are documented and restriction is New Drug Entities or New Drug Dosage warranted, the MDPAC shall hold a public (9) On an annual basis, the MO HealthNet Form Drug Prior Authorization Committee shall hearing regarding the continued restriction review all criteria in place, including prior PURPOSE: This rule outlines the process by and make a recommendation to the division. authorization, step therapy, clinical edits, fis- which new drugs or new drug dosage forms of Such recommendation shall be provided to cal edits, and the preferred drug list. Annual existing drugs may be subject to prior autho- the division, in writing, prior to the division reviews will be staggered and scheduled to rization prior to payment by Missouri’s med- making a final determination. The division occur at the scheduled meeting closest to ical assistance program. shall provide notice of the final determination completion of a full calendar year after through the Department of Social Services, approval of the criteria. If additional clinical (1) New drug entities, and new drug product MO HealthNet Division website at or fiscal information is available since the dosage forms of existing drug entities, that dss.state.mo.gov/mhd, provider bulletins, original consideration, interested parties shall have been approved by the Food and Drug and updates to the provider manual. have the opportunity to address the commit- Administration and are available on the mar- tee and request reconsideration of prior ket, shall comply with prior authorization (6) If, after the hearing referenced in section requirements imposed by the division, in authorization, step therapy, clinical edits, fis- (5) above, prior authorization of the new drug compliance with federal law. cal edits, and preferred drug list criteria. All or new drug dosage form is required, the prior authorization requirement shall be requests shall be scheduled with the division (2) Prior authorization restrictions shall con- fourteen (14) days in advance of the meeting. tinue on new drug entities and new drug reviewed at least once every twelve (12) All such presentations shall be clinically rel- product dosage forms of existing drugs until months by the MDPAC. evant and limited to a maximum of fifteen reviewed by the division and the division (15) minutes. The responsibility of schedul- eliminates the restriction or makes a final AUTHORITY: sections 208.153 and 208.201, ing the presentation shall rest with the manu- determination to require restriction. The divi- RSMo Supp. 2013.* Emergency rule filed facturer of the drug product. sion shall consider known cost and use data, May 22, 2002, effective June 1, 2002, expired medical and clinical criteria, and prudent uti- Nov. 27, 2002. Original rule filed June 3, (10) The division shall not otherwise restrict lization of state funds in the review. 2002, effective Nov. 30, 2002. Amended: the prescribing and dispensing of covered Interested parties may present clinical data to Filed Sept. 16, 2013, effective March 30, outpatient prescription drugs (other than the division. 2014.

10 CODE OF STATE REGULATIONS (8/31/18) JOHN R. ASHCROFT Secretary of State Chapter 20—Pharmacy Program 13 CSR 70-20

*Original authority: 208.153, RSMo 1967, amended performance of their official duties. than ten (10) members per committee. A quo- 1967, 1973, 1989, 1990, 1991, 2007, 2012 and 208.201, rum of fifty-one percent (51%) of the total RSMo 1987, amended 2007. (7) The DUR board shall provide, either members must be present to conduct busi- directly or through contracts between the MO ness. Regional committee members shall have 13 CSR 70-20.300 Retrospective Drug Use HealthNet Division and accredited health care the same minimum qualifications as required Review Process schools, state medical societies or state phar- for the DUR board members. Regional com- macist associations or societies or other mittee meetings shall be held every other PURPOSE: This rule establishes the division appropriate organizations, for educational out- month. The members of each committee shall process by which the Drug Use Review Board reach programs as required by P.L. 101-508, elect a chairperson, who shall serve as an ex will be established as required by Section Section 4401, to educate practitioners on com- officio member of the DUR board. 4401 of P.L. 101-508 (Omnibus Budget mon drug therapy problems with the aim of Committee members shall receive no com- Reconciliation Act of 1990) and by section improving prescribing and dispensing prac- pensation other than reasonable expenses 208.175, RSMo. tices. This outreach shall include an educa- actually incurred in the performance of their tional newsletter to MO HealthNet providers official duties. (1) Drug Use Review (DUR) Board. This rule including appropriate drug use guidelines and establishes a MO HealthNet DUR board in the MO HealthNet utilization statistics. (12) The regional review committees shall Department of Social Services, MO HealthNet conduct patient profile reviews, including Division. The board shall be composed as (8) As specified by P.L. 101-508, Section opening and closing of cases at the committee specified in section 208.175, RSMo. 4401, the DUR board shall monitor drug use, meetings. Interventions shall be initiated and and prescribing and dispensing practices in the follow-up reviews performed by the regional (2) Members of the DUR board must have the MO HealthNet program. This monitoring committees. Patterns of inappropriate or following minimum qualifications: shall include reviewing and refining therapeu- aberrant prescribing or dispensing shall be (A) Must be licensed by Missouri, with tic criteria modules used in both retrospective identified and referred to the board in order that license in active status and in good stand- and prospective DUR, as well as overseeing for targeted education to be formulated. ing; and retrospective DUR intervention methods used. (B) Must have recognized knowledge and (13) Agency Responsibility Regarding expertise in one (1) or more of the following: (9) The DUR board shall advise the Confidentiality of Information. All informa- Department of Social Services regarding all 1. The clinically appropriate prescribing tion concerning applicants and MO HealthNet activities associated with the DUR process, of covered outpatient drugs; participants shall be confidential and any dis- including identifying types of intervention 2. The clinically appropriate dispensing closure of this information shall be restricted methods to be initiated by the review commit- and monitoring of covered outpatient drugs; to purposes directly related to the administra- tees, ranging from letters to physicians and 3. Drug use review, evaluation, and tion of the medical assistance program. pharmacists, face-to-face education and edu- intervention; or Purposes directly related to administration of cational symposiums for targeted providers. 4. Medical quality assurance. the medical assistance program include: The board shall provide educational support (A) Establishing eligibility; and guidance as needed by the review commit- (3) A chairperson shall be elected by the (B) Determining the amount of medical board members. tees. The review committees, in turn, shall report intervention results and make recom- assistance; (C) Providing services for recipients; and (4) The board shall meet at least once every mendations based on these results to the (D) Conducting or assisting an investiga- ninety (90) days. A quorum of two-thirds board. tion, prosecution, or civil or criminal pro- (2/3) of the total members, including no ceeding related to the administration of the fewer than two (2) physicians or two (2) phar- (10) The DUR board shall review and research macists, is required for the board to act in its recommendations from the Drug Prior program. official capacity. Authorization Committee, as established by 13 CSR 70-20.200, regarding the advisability (14) Provider Responsibility Regarding (5) Members shall serve four (4)-year terms, of implementing or removing prior authoriza- Confidentiality of Information. All informa- except the terms of the original members, two tion requirements for a drug or class of tion concerning applicants and participants of (2) shall be appointed for a term of two (2) drugs, and make a recommendation to the medical services shall be confidential. Any years, three (3) shall be appointed for a term Department of Social Services. disclosure of this information shall be of three (3) years, and three (3) shall be restricted to purposes directly related to the appointed for a term of four (4) years. (11) Specialized DUR Committees. Subject treatment of the patient and promotion of Members may be reappointed, provided that to appropriation, up to six (6) regional review improved quality of care. The confidential minimum qualifications for membership con- committees may be appointed by the director information includes: tinue to be met. Nominations shall be of the Department of Social Services for the (A) Names and addresses; referred for final appointment by the gover- areas surrounding St. Louis, Kansas City, (B) Social Security number; nor subject to advice and consent of the sen- Springfield, Cape Girardeau, Kirksville and (C) Medical services provided; ate. As vacancies occur, the DUR board shall Columbia. Other specialized review commit- (D) Social and economic conditions or cir- solicit and select a slate of nominees. tees may be formed at the discretion of the cumstances; Department of Social Services. Members of (E) Medical data, including diagnosis and (6) The members of the board shall receive the review committees shall be physicians and past history of disease or disability; no compensation for their services other than pharmacists appointed by the DUR board, (F) Any information received for verifying reasonable expenses actually incurred in the totaling no fewer than five (5) and no more income eligibility; and

JOHN R. ASHCROFT (8/31/18) CODE OF STATE REGULATIONS 11 Secretary of State 13 CSR 70-20—DEPARTMENT OF SOCIAL SERVICES Division 70—MO HealthNet Division

(G) Any information received in connec- (B) Adverse drug-drug interaction, that is, (5) MO HealthNet Patient Counseling. As tion with the identification of legally liable the potential for, or occurrence of, an adverse part of the prospective DUR program, partic- third-party resources. medical effect as a result of the participant ipating pharmacies shall perform patient using two (2) or more drugs together; counseling according to the standards estab- AUTHORITY: sections 208.153, 208.175, (C) Drug-disease contraindication, that is lished by the Board of Pharmacy under 20 and 208.201, RSMo Supp. 2013.* Original the potential for, or occurrence of— CSR 2220-2.190. rule filed Dec. 14, 1992, effective June 7, 1. An undesirable alteration of the ther- 1993. Amended: Filed Sept. 16, 2013, effec- apeutic effect of a given prescription because (6) MO HealthNet Patient Profiles. The term, tive March 30, 2014. of the presence, in the patient for whom it is reasonable effort means that each time a MO prescribed, of a disease condition; or HealthNet patient or caregiver presents a pre- *Original authority: 208.153, RSMo 1967, amended 2. An adverse effect of the drug on the scription, the pharmacist or pharmacist’s 1973, 1989, 1990, 1991, 2007, 2012; 208.175, RSMo 1992, amended 1993, 2011; and 208.201, RSMo 1987, patient’s disease condition. designee should request profile information amended 2007. (D) Therapeutic duplication, that is, the verbally or in writing. For example, if the prescribing and dispensing of two (2) or more patient presents the prescription in person, drugs from the same therapeutic class so that the request should be made verbally, and if 13 CSR 70-20.310 Prospective Drug Use the combined daily dose puts the participant the prescription is received by mail, the Review Process and Patient Counseling at risk of an adverse medical result or incurs request should be made in writing. This does additional program costs without additional not imply that the service should be denied PURPOSE: This rule establishes provisions therapeutic benefit; solely on the basis of the patient’s refusal to for prospective drug use review and patient (E) Incorrect duration of drug treatment, supply this information. Pharmacies must counseling for MO HealthNet beneficiaries, that is, the number of days of prescribed ther- make a reasonable effort to obtain records as required by Section 4401 or Public Law apy exceeds or falls short of the recommenda- and maintain patient profiles containing, at a 101-508 (Omnibus Budget Reconciliation Act tions contained in the predetermined stan- minimum: of 1990) and by section 208.176, RSMo. dards; (A) The name, address, telephone number, (F) Drug-allergy interactions, that is, the date of birth (or age), and gender of the (1) Prospective Drug Use Review (DUR). significant potential for, or the occurrence of, patient; This rule establishes a MO HealthNet an allergic reaction as a result of drug thera- (B) Individual medical history, if signifi- prospective drug use review process within py; and cant, including disease states, known aller- the Department of Social Services, MO (G) Clinical abuse/misuse, that is, the gies and drug reactions, and a comprehensive HealthNet Division, as specified in section occurrence of situations referred to in the list of medications and relevant devices; and 208.176, RSMo. definitions of abuse, gross overuse, overuti- (C) Pharmacist’s comments relevant to the lization and underutilization, as defined in 42 individual’s drug therapy. (2) Electronic Point-of-Sale Review. The MO CFR 456.702, and incorrect dosage and HealthNet Division shall provide for electron- incorrect duration, as defined in subsections (7) Documentation of Offer to Counsel. The ic point-of-sale review of drug therapy using (3)(A) and (E) of this rule. pharmacist shall document for each predetermined standards before each prescrip- MO HealthNet patient’s prescription in a uni- tion is dispensed to the MO HealthNet partic- (4) Screens Available for MO HealthNet form fashion, whether the offer to counsel was ipant or MO HealthNet participant’s caregiver Beneficiaries. The following screens will be accepted or refused by the patient or the for the current date of service. The process provided by the pharmacy point of service patient’s agent. will provide screening for potential drug ther- system: apy problems using clinical modules which (A) Drug Disease Contraindications. (8) Agency Responsibility Regarding Con- have been reviewed and approved for use by 1. Drug (actual) disease precaution. fidentiality of Information. All information the Missouri Drug Use Review Board. 2. Inferred Drug Disease precaution; concerning applicants and participants of med- (B) Drug to Drug Interactions; ical services shall be kept confidential by the (3) Federal Prospective DUR screening (C) Side Effects. MO HealthNet Division, and any disclosure of requirements for MO HealthNet beneficia- 1. Additive toxicity side effects. this information shall be restricted to purposes ries. 42 CFR part 456.705(b) requires that 2. Medical condition/additive side directly related to the administration of the the state plan must provide for a point of dis- effect. medical assistance program. Purposes directly tribution review of drug therapy using prede- 3. Side effect. related to administration of the medical assis- termined standards before each prescription 4. Drug indicated for side effect of pre- tance program include: is filled or delivered to the participant or the viously prescribed drug; (A) Establishing eligibility; participant’s caregiver. The review, per- (D) Dose Range Checking. (B) Determining the amount of medical formed with or without online access to the 1. High dose alert. assistance; pharmacy point of service system, must 2. Low dose alert; (C) Providing services for participants; and include screening to identify potential drug (E) Minimum/Maximum Daily Dose. (D) Conducting or assisting an investiga- therapy problems of the following types: 1. High dose alert. tion, prosecution, or civil or criminal pro- (A) Incorrect drug dosage, that is, the 2. Low dose alert; ceeding related to the administration of the dosage lies outside the daily dosage range (F) Duplicate Therapy Checking. program. specified in predetermined standards as nec- 1. Therapeutic duplication. essary to achieve therapeutic benefit. Dosage 2. Ingredient duplication; and (9) Provider Responsibility Regarding Con- range is the strength multiplied by the quanti- (G) Duration of Therapy (H2). fidentiality of MO HealthNet Beneficiary ty dispensed divided by days supply; 1. Excessive duration alert. Information. All information concerning

12 CODE OF STATE REGULATIONS (8/31/18) JOHN R. ASHCROFT Secretary of State Chapter 20—Pharmacy Program 13 CSR 70-20

applicants and participants of medical ser- 1. The PRA owed for existing pharma- (2) Payment of the PRA. vices shall be confidential. Any disclosure of cies shall be calculated by multiplying the (A) Offset. this information by the pharmacy provider pharmacy’s total gross retail prescription 1. Each pharmacy may request that its shall be restricted to purposes directly related receipts by the tax rate determined by the PRA offset against any MO HealthNet pay- to the treatment of the patient and promotion department. Subject to the limitations estab- ment due to that pharmacy. of improved quality of care, or conducting or lished in section 338.520, RSMo, such said A. A statement authorizing the offset assisting an investigation, prosecution, or tax rate shall be uniform and shall not exceed must be on file with the division before any civil or criminal proceeding related to the five percent (5%). offset may be made relative to the PRA by the administration of the program. The confiden- 2. The PRA shall be divided by and col- pharmacy. tial information includes: lected over the number of months for which B. Assessments shall be allocated and (A) Names and addresses; the PRA is effective. deducted over the applicable service period. (B) Social Security number; 3. The initial PRA owed by a newly C. Any balance due after the offset (C) Medical services provided; licensed pharmacy shall be calculated by esti- shall be remitted to the director of the (D) Social and economic conditions or cir- cumstances; mating the total prescription sales and multi- Department of Revenue and be deposited in (E) Medical data, including diagnosis and plying the estimate by the rate determined by the state treasury to the credit of the past history of disease or disability; the department, as described in paragraph Pharmacy Reimbursement Allowance Fund. (F) Any information received for verifying (1)(B)1. D. If the remittance is not received income eligibility; and 4. If a pharmacy ceases to provide out- before the next MO HealthNet payment cycle, (G) Any information received in connec- patient prescription drugs to the general pub- the division shall offset the balance due from tion with the identification of legally liable lic, the pharmacy is not required to pay the that check. third party resources. PRA during the time it did not provide outpa- (B) Check. tient prescription drugs. 1. If no offset has been authorized by the AUTHORITY: sections 208.153 and 208.201, 5. If the pharmacy reopens, it shall pharmacy, the division will begin collecting RSMo Supp. 2013.* Original rule filed June resume paying the PRA. It shall owe the same the pharmacy reimbursement allowance on 3, 1993, effective Dec. 9, 1993. Amended: PRA as it did prior to closing, if the PRA has the first day of each month for the preceding Filed Sept. 16, 2013, effective March 30, not changed per paragraph (1)(B)1. months. 2014. (C) Each pharmacy shall submit an affi- 2. The PRA shall be remitted by the davit to the department with the following pharmacy to the department. The remittance *Original authority: 208.153, RSMo 1967, amended information: shall be made payable to the director of the 1973, 1989, 1990, 1991, 2007, 2012 and 208.201, RSMo 1987, amended 2007. 1. Pharmacy name; Department of Revenue and be deposited in 2. Contact; the state treasury to the credit of the 3. Telephone number; Pharmacy Reimbursement Allowance Fund. 13 CSR 70-20.320 Pharmacy Reimburse- 4. Address; (C) Failure to comply with this request for ment Allowance 5. Federal tax ID number; information or failure to pay the PRA. 6. MO HealthNet pharmacy number (if 1. If a pharmacy fails to comply with a PURPOSE: This rule establishes a Pharmacy applicable); request for information from the MO Federal Reimbursement Allowance and the 7. Pharmacy sales (total); HealthNet Division or fails to pay its PRA methodologies to determine the formula for 8. MO HealthNet pharmacy sales; within thirty (30) days of notice, the PRA the amount of allowance each pharmacy is 9. Number of paid MO HealthNet pre- shall be delinquent. required to pay for the privilege of providing scriptions; and 2. For any delinquent PRA, the depart- outpatient prescription drugs. 10. Gross receipts attributable to pre- ment may: scription drugs that are delivered directly to A. Proceed to enforce the state’s lien (1) Pharmacy Reimbursement Allowance the patient via common carrier, by mail, or a of the property of the pharmacy; (PRA). PRA shall be assessed as described in courier service. B. Cancel or refuse to issue, extend, this section. (D) The department shall prepare a confir- or reinstate the MO HealthNet provider (A) Definitions. mation schedule of the information provided agreement; or 1. Department—Department of Social by each pharmacy and the amount of PRA C. Seek denial, suspension, or revo- Services. that is due from the pharmacy. cation of license granted under Chapter 338, 2. Director—Director of Department of (E) Each pharmacy shall review the infor- RSMo. Social Services. mation prepared by the department and the 3. The new owner, as a result of a 3. Division—MO HealthNet Division. amount of PRA calculated by the department change in ownership, shall have his/her PRA 4. Gross retail prescription receipts— to verify that the information is correct. paid by the same method the previous owner For ease of administration for the department 1. If the information supplied by the elected. as well as the industry, this shall be an annual department is incorrect, the facility, within (D) Each pharmacy, upon receiving written amount. The basis of tax in any fiscal year thirty (30) calendar days of receiving the con- notice of the final determination of its PRA, will be the gross prescription sales of the last firmation schedule must notify the division may file a protest with the director of the calendar year prior to the previous fiscal and explain the correction. department setting forth the grounds on year. 2. If the division does not receive cor- which the protest is based, within thirty (30) (B) Each pharmacy engaging in the busi- rected information within thirty (30) calendar days from the date of receipt of written notice ness of providing outpatient prescription days, it will be assumed to be correct, unless from the department. The director of the drugs in Missouri to the general public shall the pharmacy files a protest in accordance department shall reconsider the determina- pay a PRA. with subsection (2)(D) of this regulation. tion and, if the pharmacy so requested, grant

JOHN R. ASHCROFT (8/31/18) CODE OF STATE REGULATIONS 13 Secretary of State 13 CSR 70-20—DEPARTMENT OF SOCIAL SERVICES Division 70—MO HealthNet Division

the pharmacy a hearing to be held within program. interventions based on nationally accepted evi- forty-five (45) days after the protest was dence-based guidelines. Pharmacists are then filed, unless extended by agreement between PUBLISHER’S NOTE: The secretary of state messaged about only those participants who the pharmacy and the director. The director has determined that the publication of the are identified for one (1) or more issues perti- shall issue a final decision within forty-five entire text of the material which is incorpo- nent to the evidence-based criteria. The rules (45) days of the completion of the hearing. rated by reference as a portion of this rule engine uses current nationally accepted evi- After a final decision by the director, a phar- would be unduly cumbersome or expensive. dence-based guidelines for clinically appropri- macy’s appeal of the director’s final decision This material as incorporated by reference in ate drug therapy, and applies this criteria to shall be to the Administrative Hearing this rule shall be maintained by the agency at thirty-six (36) months of paid participant Commission in accordance with section its headquarters and shall be made available claims data which includes drugs, diagnoses, 208.156, RSMo 2000 and section 621.055, to the public for inspection and copying at no and procedures. When an eligible participant RSMo Supp. 2008. more than the actual cost of reproduction. meets certain disease-based criteria a pharma- (E) PRA Rates. This note applies only to the reference mate- cist may perform a wide variety of MTM ser- 1. The PRA tax rate will be a uniform rial. The entire text of the rule is printed vices directed by MO HealthNet to address effective rate of one and twenty hundredths here. specific treatment needs, such as: percent (1.20%) with an aggregate annual (A) Counseling participants on the impor- adjustment, by the MO HealthNet Division, (1) Administration. The Medication Therapy tance of medication adherence (alerting par- not to exceed five hundredths percent (.05%) Management (MTM) program shall be admin- ticipants to missed dosages and refills); based on the pharmacy’s total prescription istered by the Department of Social Services, (B) Providing medication education; volume. MO HealthNet Division. The MTM services (C) Providing self-care education for spe- 2. Beginning January 1, 2010, the PRA covered, the program limitations, and the cific chronic conditions; tax rate will be a uniform effective rate of one maximum allowable fees for all covered ser- (D) Contacting physicians to schedule and eighty-two hundredths percent (1.82%) vices shall be determined by the Department diagnostic testing; with an aggregate quarterly adjustment, by of Social Services, MO HealthNet Division, (E) Contacting physicians to make drug the MO HealthNet Division, not to exceed and shall be included in the pharmacy provider therapy recommendations; or five tenths percent (0.5%) based on the phar- manual and provider bulletins, which are (F) Connecting participants with other com- macy’s total prescription volume. incorporated by reference and made a part of munity-based resources as needed. 3. The maximum rate shall be five per- this rule as published by the Department of cent (5%). Social Services, MO HealthNet Division, 615 (5) The service is comprised of the following Howerton Court, Jefferson City, MO 65109, components: AUTHORITY: sections 208.201 and 338.505, at its website at dss.mo.gov/mhd/index.htm, (A) Assessing a participant’s health status; RSMo Supp. 2009.* Emergency rule filed September 1, 2015. This rule does not incor- (B) Developing a medication treatment June 20, 2002, effective July 1, 2002, expired porate any subsequent amendments or addi- plan; Feb. 27, 2003. Original rule filed July 15, tions. (C) Monitoring and evaluating a partici- 2002, effective Feb. 28, 2003. Amended: pant’s response to therapy; Filed Feb. 3, 2003, effective Aug. 30, 2003. (2) Persons Eligible. A person who is eligible (D) Providing a comprehensive medication Amended: Filed Nov. 3, 2003, effective April for Title XIX (Medicaid) or Title XXI (State review to identify, resolve, and prevent med- 30, 2004. Emergency amendment filed Sept. Children’s Health Insurance Program) or ication-related problems; 12, 2008, effective Sept. 22, 2008, expired Blind Pension and who meets certain disease- (E) Documenting the care provided and March 20, 2009. Amended: Filed Sept. 12, based criteria included in their health profile. communicating essential information to a 2008, effective April 30, 2009. Amended: participant’s primary care providers; Filed July 1, 2009, effective Jan. 30, 2010. (3) Provider Participation. To be eligible for (F) Providing oral education and training Emergency amendment filed Dec. 1, 2009, participation in the MO HealthNet MTM to enhance participant understanding and effective Jan. 1, 2010, expired June 29, 2010. program, a provider must be a qualified appropriate use of medications; Emergency amendment filed June 17, 2010, Missouri licensed pharmacist and have an (G) Providing information, support ser- effective July 1, 2010, expired Dec. 27, 2010. active MO HealthNet provider status, and vices, and resources to enhance participant Amended: Filed Dec. 1, 2009, effective June must have successfully completed two (2) adherence to therapeutic regimens; and 30, 2010. hours of ACPE (Accreditation Counsel for (H) Coordinating and integrating MTM Pharmacy Education) accredited continuing *Original authority: 208.201, RSMo 1987, amended 2007 services within the broader health care ser- and 338.505, RSMo 2002. education focused on the administration of vices provided to a participant. MTM approved by the MO HealthNet Division. (6) Reimbursement. Pharmacists will receive 13 CSR 70-20.330 Medication Therapy the payment for participating in MTM. The Management (MTM) Program (4) Medication Therapy Management Services. payment is contingent upon the provider log- MTM Services are available to any currently ging on to the electronic web tool to view, PURPOSE: This rule establishes the regula- eligible non-managed care MO HealthNet par- reserve, and complete interventions. Once an tory basis for the administration of the ticipant for whom the qualifying pharmacist intervention is complete, providers will submit MO HealthNet Medication Therapy receives a MO HealthNet directed electronic an electronic medical claim to MO HealthNet. Management (MTM) program, including des- drug utilization review (DUR) message The payment status of these claims will be ignation of professional persons who may through a Point-of-Sale transaction. MO reflected on the provider’s remittance advice. perform medication therapy management ser- HealthNet uses a clinically based rules engine The fee schedule is available at vices and defined covered services within the that juries which participants require MTM dss.mo.gov/mhd/providers/pages/cptagree.htm.

14 CODE OF STATE REGULATIONS (8/31/18) JOHN R. ASHCROFT Secretary of State Chapter 20—Pharmacy Program 13 CSR 70-20

AUTHORITY: section 208.201, RSMo Supp outpatient claims correctly submitted with the and clinical edits are designed to enhance 2013.* Original rule filed July 30, 2015, appropriate J-Code and the corresponding patient care and optimize the use of program effective Jan. 30, 2016. NDC, the system will automatically generate a funds through therapeutically prudent use of separate drug claim for the NDC to process as pharmaceuticals. The edits are based on evi- *Original authority: 208.201, RSMo 1987, amended 2007. a pharmacy claim and will appear as a sepa- dence-based clinical criteria and nationally rate claim on your Remittance Advice. The recognized peer-reviewed information. This 13 CSR 70-20.340 National Drug Code corresponding line with J-Code and NDC will clinical information is paired with fiscal eval- Requirement be dropped from the medical or outpatient uation and then developed into a therapeutic claim. If an NDC is not provided, the J-Code class PDL recommendation. The PDL PURPOSE: This rule implements the require- will remain on the claim to report the denied process incorporates clinical edits, including ment for the National Drug Code (NDC) for line. If the drug being provided does not have step therapies, into the MHD pharmacy pro- all medications administered in the clinic or a J-Code associated with it, the appropriate gram. Claims for drugs will automatically outpatient hospital setting. The Deficit Healthcare Common Procedure Coding and transparently be approved for those Reduction Act of 2005 (DRA) requires states System (HCPCS) procedure code should be patients who meet any of the system approval to collect rebates for certain physician- submitted with an NDC. For drugs without a criteria. For those patients who do not meet administered drugs. valid HCPCS procedure code, revenue code the system approval criteria, the drugs will 0250 “General Classification: Pharmacy” require a call to the MHD Drug Prior (1) Claims from 340B health care facilities must be used with the appropriate NDC. Authorization hotline at (800) 392-8030 to for outpatient hospital covered are exempt Only drugs and items used during outpatient initiate a review and potentially authorize from the NDC requirement in this rule so care in the hospital are covered. Take-home payment of claims. Providers may also use long as those claims utilize a valid J-Code medications and supplies are not covered by the CyberAccess tool to prospectively deter- (not a dump code) and comply with all other MHD under the Hospital Program. mine if a drug is a preferred agent or requires applicable state and federal laws. edit override, electronically initiate an edit (4) A critical component to submitting claims override review, and to review a participant’s (2) All drug products produced by manufac- with an NDC is to ensure that the appropriate MHD paid claim history. turers that have entered into a rebate agree- HCPCS procedure code is billed with each ment with the Federal Government are reim- NDC. To ensure accurate billing of drug (7) The quantity to be billed for injectables bursable under the MHD Pharmacy Program, charges, MHD will use the Noridian and other types of medications dispensed to with the exception of Drug Efficacy Study Crosswalk (www.dmepdac.com) to determine MHD participants must be calculated as fol- Implementation (DESI) drugs and drugs spec- whether the appropriate HCPCS procedure lows: ified in Section 13, “Benefits and Limitations,” code is billed for the submitted NDC. (A) Containers of medication in solution in the Pharmacy Manual. The MHD Pharmacy Claims will be denied if the NDC submitted (for example, ampoules, bags, bottles, vials, Manual can be found on the MHD website at: is not valid for the HCPCS procedure code syringes) must be billed by exact cubic cen- http://manuals.momed.com/collections/collec- submitted. timeters or milliliters (cc or mL) dispensed, tion_pha/print.pdf. A list of manufacturers even if the quantity includes a decimal (e.g., that have entered into a rebate agreement (5) Effective for dates of service on or after if three (3) 0.5 mL vials are dispensed, the with the Federal Government (along with the April 1, 2016, MO HealthNet Division correct quantity to bill is 1.5 mL); Labeler Code which is the first five (5) dig- (MHD) will require the National Drug Code (B) Single dose syringes and single dose its of the NDC number by which products (NDC) for all medications administered in vials must be billed per cubic centimeters or may also be identified), can be found on the the clinic or outpatient hospital setting, to milliliters (cc or mL), rather than per syringe Centers for Medicare and Medicaid Services comply with federal law. MHD must collect or per vial; (CMS) website, in Drug Manufacturer the eleven- (11-) digit NDC on all outpatient (C) Ointments must be billed per number Contact Information at: http://www.medic- drug claims submitted to MHD from all of grams even if the quantity includes a deci- aid.gov/Medicaid-CHIP-Program- providers for rebate purposes in order to mal; Information/By-Topics/Benefits/Prescription- receive federal financial participation. (D) Eye drops must be billed per number Drugs/Medicaid-Drug-Rebate- Providers will be required to submit their of cubic centimeters or milliliters (cc or mL) Program.html. Products for which the claims with the exact NDC that appears on in each bottle even if the quantity includes a Labeler Code is not included on the list are the product dispensed or administered to decimal; not reimbursable under the MHD Pharmacy receive payment from MHD. The NDC is (E) Powder filled vials and syringes that Program. found on the medication’s packaging and require reconstitution must be billed by the must be submitted in the five (5) digit – four number of vials; (3) Drug charges submitted by providers on an (4) digit – two (2) digit format. If the NDC (F) Combination products, which consist electronic Professional or Institutional ASC does not appear in the five (5) digit – four (4) of devices and drugs, designed to be used X12 837 Health Care claim transaction or digit – two (2) digit format on the packaging, together, are to be billed as a kit. Quantity manually entered on a medical or outpatient zero(s) (0) may be entered in front of the sec- will be the number of kits used; claim into MHD’s billing website eMOMED tion that does not have the required number of (G) The product Herceptin, by Genentech, (www.emomed.com), are to be billed with a digits. must be billed by milligram rather than by valid J-Code and a valid NDC for each med- vial due to the stability of the drug; and ication, including injections, provided to the (6) All drug claims shall be routed through an (H) Non-Vaccines for Children (VFC) participant. Medical or outpatient claim lines automated computer system to apply edits Immunizations and vaccines must be billed by submitted with a J-Code without the corre- specifically designed to ensure effective drug the cubic centimeters or milliliters (cc or mL) sponding NDC will be denied. For medical or utilization. The Preferred Drug List (PDL) dispensed, rather than per dose.

JOHN R. ASHCROFT (8/31/18) CODE OF STATE REGULATIONS 15 Secretary of State 13 CSR 70-20—DEPARTMENT OF SOCIAL SERVICES Division 70—MO HealthNet Division

(8) Contrast materials and radiopharmaceuti- cals used in radiologic procedures may be billed separately using the appropriate HCPCS code and/or the NDC representing the materials or agent used in the procedure. If available, MHD would prefer the NDC for reporting purposes. If the material or agent used does not have an NDC, the appropriate HCPCS code alone is acceptable. All HCPCS codes for contrast materials and radiopharmaceuticals are manually priced and must be billed with the manufacturer’s invoice of cost attached to the claim.

AUTHORITY: sections 208.153 and 208.201, RSMo Supp. 2013.* Emergency rule filed June 19, 2015, effective July 1, 2015, expired Dec. 28, 2015. Original rule filed July 1, 2015, effective Feb. 29, 2016.

*Original authority: 208.153, RSMo 1967, amended 1967, 1973, 1989, 1990, 1991, 2007, 2012 and 208.201, RSMo 1987, amended 2007.

16 CODE OF STATE REGULATIONS (8/31/18) JOHN R. ASHCROFT Secretary of State