[ Text of section added by 2024, 342, Sec. 34 effective April 8, 2025 applicable to all contracts entered into, renewed or amended on or after July 1, 2025. See 2024, 342, Sec. 39.]Section 4DDD.
(a)As used in this section, the following words shall have the following meanings unless the context clearly requires otherwise:"Brand name drug'', a drug that is:
(i)produced or distributed pursuant to an original new drug application approved under 21 U.S.C. 355(c) except for: (A)any drug approved through an application submitted under section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act that is pharmaceutically equivalent, as that term is defined by the United States Food and Drug Administration, to a drug approved under 21 U.S.C. 355(c); (B)an abbreviated new drug application t
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[ Text of section added by 2024, 342, Sec. 34 effective April 8, 2025 applicable to all contracts entered into, renewed or amended on or after July 1, 2025. See 2024, 342, Sec. 39.]Section 4DDD. (a) As used in this section, the following words shall have the following meanings unless the context clearly requires otherwise:"Brand name drug'', a drug that is: (i) produced or distributed pursuant to an original new drug application approved under 21 U.S.C. 355(c) except for: (A) any drug approved through an application submitted under section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act that is pharmaceutically equivalent, as that term is defined by the United States Food and Drug Administration, to a drug approved under 21 U.S.C. 355(c); (B) an abbreviated new drug application that was approved by the United States Secretary of Health and Human Services under section 505(c) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 355(c), before the date of the enactment of the Drug Price Competition and Patent Term Restoration Act of 1984, Public Law 98-417, 98 Stat. 1585; or (C) an authorized generic drug as defined in 42 C.F.R. 447.502; (ii) produced or distributed pursuant to a biologics license application approved under 42 U.S.C. 262(a)(2)(C); or (iii) identified by the health benefit plan as a brand name drug based on available data resources, including Medi-Span."Generic drug'', a retail drug that is: (i) marketed or distributed pursuant to an abbreviated new drug application approved under 21 U.S.C. 355(j); (ii) an authorized generic drug as defined in 42 C.F.R. 447.502; (iii) a drug that entered the market before January 1, 1962 and was not originally marketed under a new drug application; or (iv) identified by the health benefit plan as a generic drug based on available data resources, including Medi-Span.(b) A subscription certificate under an individual or group medical service agreement delivered, issued or renewed within the commonwealth shall identify 1 generic drug and 1 brand name drug used to treat each of the following chronic conditions: (i) diabetes; (ii) asthma; and (iii) the 2 most prevalent heart conditions among its enrollees.(c) The carrier shall identify insulin as the drug used to treat diabetes. In determining the 1 generic drug and 1 brand name drug used to treat each chronic condition, the carrier shall consider whether the drug is:(i) of clear benefit and strongly supported by clinical evidence;(ii) likely to: (A) reduce hospitalizations or emergency department visits; (B) reduce future exacerbations of illness progression; or (C) improve quality of life;(iii) cost effective for the carrier and its enrollees;(iv) at low risk for overutilization, abuse, addiction, diversion or fraud; and(v) one of the most widely utilized as a treatment for the chronic condition.(d) A subscription certificate under an individual or group medical service agreement delivered, issued or renewed within the commonwealth shall provide coverage for the brand name drugs and generic drugs identified pursuant to subsection (b). Coverage for the identified generic drugs shall not be subject to any cost-sharing, including co-payments and co-insurance and shall not be subject to any deductible; provided, however, that cost-sharing shall be required if the applicable plan is governed by the Internal Revenue Code and would lose its tax-exempt status as a result of the prohibition on cost-sharing under this section. Coverage for identified brand name drugs shall not be subject to any deductible or co-insurance and any co-payment shall not exceed $25 per 30-day supply. Coverage for 1 brand name insulin drug per dosage and type, including rapid-acting, short-acting, intermediate-acting, long-acting, ultra long-acting and premixed under this section shall not be subject to any deductible or co-insurance and any co-payment shall not exceed $25 per 30-day supply.(e) The carrier shall implement a continuity of coverage policy to apply to enrollees that are new to the plan and that provides coverage for a 30-day fill of a United States Food and Drug Administration-approved drug reimbursed through a pharmacy benefit that the enrollee has already been prescribed and on which the enrollee is stable, upon documentation by the enrollee's prescriber; provided, however, that a carrier shall not apply any greater deductible, coinsurance, copayments or out-of-pocket limits than would otherwise apply to other drugs covered by the plan.(f) The carrier may make changes in its selection of drugs pursuant to this section not more than annually.(g) The carrier shall make public the drugs selected pursuant to subsection (b).