Commonwealth of Massachusetts Executive Office of Health and Human Services Office of Medicaid 600 Washington Street Boston, MA 02111 www.mass.gov/masshealth MASSHEALTH TRANSMITTAL LETTER PHM-55 June 2006 TO: Pharmacy Providers Participating in MassHealth FROM: Beth Waldman, Medicaid Director RE: Pharmacy Manual (Revised Regulations About Tobacco Cessation Services) Beginning July 1, 2006, MassHealth will cover individual and group tobacco cessation counseling and pharmacotherapy through the MassHealth tobacco cessation benefit. Those members eligible to receive physician services, community health center services, acute outpatient hospital services, and pharmacy services are covered for tobacco cessation services, based on their MassHealth coverage type as described at 130 CMR 450.105. Pharmacotherapy Benefit MassHealth will cover medically necessary drugs used for tobacco cessation, subject to all other provisions of 130 CMR 406.000. Members may obtain a 90-day supply of the nicotine patch, gum, or lozenge, per cessation attempt; the nicotine inhaler and nasal spray require prior authorization. A maximum of two 90-day treatment regimens are covered per member per 12month cycle. Additional nicotine replacement therapy (NRT) requires prior authorization. The pharmacotherapy benefit also covers other medically necessary drugs for tobacco cessation, such as bupropion (the generic form of Zyban). Please see the MassHealth Drug List for further details about the pharmacotherapy benefit for tobacco cessation. The MassHealth Drug List can be found at www.mass.gov/druglist. It can also be accessed from the MassHealth Pharmacy Program home page at www.mass.gov/masshealth/pharmacy. Pharmacy Regulation Changes The pharmacy regulations have been changed by removing the blanket restriction on coverage of drugs indicated for use as aids for tobacco cessation treatment. This permits reimbursement to pharmacies for the dispensing of these drugs to eligible members. These regulations are effective July 1, 2006. If you have any questions about the information in this transmittal letter please contact MassHealth Customer Service at 1-800-841-2900, e-mail your inquiry to providersupport@mahealth.net, or fax your inquiry to 617-988-8974. NEW MATERIAL (The pages listed here contain new or revised language.) Pharmacy Manual Pages 4-7 and 4-8 MASSHEALTH TRANSMITTAL LETTER PHM-55 June 2006 Page 2 OBSOLETE MATERIAL (The pages listed here are no longer in effect.) Pharmacy Manual Pages 4-7 and 4-8 — transmitted by Transmittal Letter PHM-54 Commonwealth of Massachusetts MassHealth Provider Manual Series Pharmacy Manual Subchapter Number and Title 4. Program Regulations (130 CMR 406.000) Page 4-7 Transmittal Letter PHM-55 Date 07/01/06 (d) drugs packaged in such a way that the smallest quantity that may be dispensed is larger than a 30-day supply (for example, inhalers, ampules, vials, eye drops, and other sealed containers not intended by the manufacturer to be opened by any person other than the end user of the product); (e) drugs in topical dosage forms that do not allow the pharmacist to accurately predict the rate of the product’s usage (for example, lotions or ointments); (f) products generally dispensed in the original manufacturer’s packaging (for example, fluoride preparations, prenatal vitamins, and over-the-counter drugs); and (g) methylphenidate and amphetamine prescribed in 60-day supplies. (E) Prescription-Splitting. Providers must not split prescriptions by filling them for a period or quantity less than that specified by the prescriber. For example, a prescription written for a single 30-day supply may not be split into three 10-day supplies. The MassHealth agency considers prescription-splitting to be fraudulent. (See 130 CMR 450.238(B)(6).) (F) Excluded, Suspended, or Terminated Clinicians. The MassHealth agency does not pay for prescriptions written by clinicians who: (1) have been excluded from participation based on a notice by the U.S. Department of Health and Human Services Office of Inspector General; or (2) the MassHealth agency has suspended, terminated, or denied admission into its program for any other reason. 406.412: Covered Drugs and Medical Supplies (A) Drugs. The MassHealth Drug List specifies the drugs that are payable under MassHealth. In addition, the following rules apply. (1) Legend Drugs. The MassHealth agency pays only for legend drugs that are approved by the U.S. Food and Drug Administration and manufactured by companies that have signed rebate agreements with the U.S. Secretary of Health and Human Services pursuant to 42 U.S.C. 1396r-8. Payment is calculated in accordance with DHCFP regulations at 114.3 CMR 31.00: Prescribed Drugs. (2) Nonlegend Drugs. Payment by the MassHealth agency for nonlegend drugs is calculated in accordance with DHCFP regulations at 114.3 CMR 31.00: Prescribed Drugs. (B) Medical Supplies. (1) The MassHealth agency pays only for the following medical supplies through POPS: (a) blood and urine testing reagent strips used for the management of diabetes; (b) disposable insulin syringe and needle units; (c) insulin cartridge delivery devices and needles or other devices for injection of medication (for example, Epipens); (d) lancets; (e) drug delivery systems for use with metered dose inhalers (for example, aerochambers); and (f) alcohol swabs. (2) Payment and coverage for all other medical supplies are described in MassHealth durable medical equipment regulations at 130 CMR 409.000. Commonwealth of Massachusetts MassHealth Provider Manual Series Pharmacy Manual Subchapter Number and Title 4. Program Regulations (130 CMR 406.000) Page 4-8 Transmittal Letter PHM-55 Date 07/01/06 406.413: Limitations on Coverage of Drugs (A) Interchangeable Drug Products. The MassHealth agency pays no more for a brand-name interchangeable drug product than its generic equivalent unless: (1) the prescriber has requested and received prior authorization from the MassHealth agency for a nongeneric multiple-source drug (see 130 CMR 406.422); and (2) the prescriber has written on the face of the prescription in the prescriber's own handwriting the words "brand name medically necessary" under the words "no substitution" in a manner consistent with applicable state law. These words must be written out in full and may not be abbreviated. (B) Drug Exclusions. The MassHealth agency does not pay for the following types of drugs or drug therapy. (1) Cosmetic. The MassHealth agency does not pay for legend or nonlegend preparations for cosmetic purposes or for hair growth. (2) Cough and Cold. The MassHealth agency does not pay for legend or nonlegend drugs used solely for the symptomatic relief of coughs and colds, including but not limited to, those that contain an antitussive or expectorant as a major ingredient, unless dispensed to an institutionalized member. (3)Fertility. The MassHealth agency does not pay for any drug used to promote male or female fertility. (4) Obesity Management. The MassHealth agency does not pay for any drug used for the treatment of obesity. (5) Less-Than-Effective Drugs. The MassHealth agency does not pay for drug products (including identical, similar, or related drug products) that the U.S. Food and Drug Administration has proposed, in a Notice of Opportunity for Hearing (NOOH), to withdraw from the market because they lack substantial evidence of effectiveness for all labeled indications. (6) Experimental and Investigational Drugs. The MassHealth agency does not pay for any drug that is experimental, medically unproven, or investigational in nature. (7) Drugs for Sexual Dysfunction. The MassHealth agency does not pay for drugs when used for the treatment of male or female sexual dysfunction. (C) Service Limitations. (1) MassHealth covers drugs that are not explicitly excluded under 130 CMR 406.413(B). The limitations and exclusions in 130 CMR 406.413(B)(1) through (5) do not apply to medically necessary drug therapy for MassHealth Standard enrollees under age 21. The MassHealth Drug List specifies the drugs that are payable under MassHealth. Any drug that does not appear on the MassHealth Drug List requires prior authorization, as set forth in 130 CMR 406.000. The MassHealth Drug List can be viewed online at www.mass.gov/druglist, and copies may be obtained upon request. The MassHealth agency will evaluate the prior-authorization status of drugs on an ongoing basis, and update the MassHealth Drug List accordingly. See 130 CMR 450.303.