130 CMR, § 406.413

Current through Register 1533, October 25, 2024

Section 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 (see130 CMR 406.422.); and

(2) the prescriber certified on the prescription that the brand-name drug is

(a) medically necessary and may not be substituted in a manner consistent with Massachusetts Department of Public Health regulations, and with all other applicable state and federal regulations; and

(b) is prescribed in the appropriate manner (e.g., written or electronic) and consistent with Massachusetts Department of Public Health regulations; or

(3) the MassHealth agency designates the brand-name drug as preferred in the Brand-name Preferred section of the MassHealth Drug List because the net cost of the brand-name drug after consideration of all rebates, is less than the cost of the generic equivalent.

(B)Drug Exclusions. The MassHealth agency does not pay for the following types of prescription or over-the-counter drugs or drug therapy.

(1)Cosmetic. The MassHealth agency does not pay for any drug when used for cosmetic purposes or for hair growth, unless medically neccessary.

(2)Cough and Cold. The MassHealth agency does not pay for any drug 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 a member who is a resident in a nursing facility or an intermediate care facility for individuals with intellectual disabilities (ICF/IID).

(3)Fertility. The MassHealth agency does not pay for any drug used to promote fertility.

(4)Less-than-effective Drugs. The MassHealth agency does not pay for any 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.

(5)Experimental and Investigational Drugs. The MassHealth agency does not pay for any drug that is experimental, medically unproven, or investigational in nature.

(6)Drugs for Sexual Dysfunction. The MassHealth agency does not pay for any drugs when used for the treatment of 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) do not apply to medically necessary drug therapy for MassHealth Standard and CommonHealth enrollees younger than 21 years old. The MassHealth Drug List specifies those 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. See130 CMR 450.303: Prior Authorization.

(2) The MassHealth agency does not pay for the following types of drugs, or drug therapies or non-drug products without prior authorization:

(a) immunizing biologicals and tubercular (TB) drugs that are supplied to the provider free of charge through local boards of public health or through the Massachusetts Department of Public Health (DPH); and

(b) any drug, drug therapy, or non-drug product designated in the MassHealth Drug List as requiring prior authorization.

(3) The MassHealth agency does not pay for any drug prescribed for other than the FDA-approved indications as listed in the package insert, except as the MassHealth agency determines to be consistent with current medical evidence.

(4) The MassHealth agency does not pay for any drugs that are provided as a component of a more comprehensive service for which a single rate of pay is established in accordance with 130 CMR 450.307: Unacceptable Billing Practices.