A 1428: Requires insurers to cover the substitution of a brand name prescription drug when the federal food and drug administration has declared that there is a supply issue with a generic drug.

  
  STATE OF NEW YORK ________________________________________________________________________ 1428 2025-2026 Regular Sessions  IN ASSEMBLY January 9, 2025 ___________ Introduced by M. of A. FORREST -- read once and referred to the Commit- tee on Insurance AN ACT to amend the insurance law, in relation to substituting brand name prescription drugs in the case of a drug shortage The People of the State of New York, represented in Senate and Assem- bly, do enact as follows: 1 Section 1. Section 3242 of the insurance law is amended by adding a 2 new subsection (d) to read as follows: 3 (d) (1) As used in this subsection: 4 (A) "Eligible prescription drug" means a prescription drug approved 5 under 21 U.S.C. 355(c) that is not under patent. 6 (B) "Generic drug" means a drug that is approved pursuant to an appli- 7 cation referencing an eligible prescription drug that is submitted under 8 subsection (j) of Section 505 of the Federal Food, Drug, and Cosmetic 9 Act, 21 U.S.C. 355. 10 (C) "Supply issue" means a drug shortage or meaningful disruption as 11 defined in 21 U.S.C. 356(c). 12 (2) In the event an AB-rated generic equivalent or interchangeable 13 biological product for an eligible prescription drug is covered in an 14 insurer's formulary and such generic drug equivalent is unavailable due 15 to a supply issue which has been recognized by the federal food and drug 16 administration pursuant to 21 U.S.C. 356e and the dosage cannot be 17 adjusted, an insurer that delivers or issues for delivery in this state 18 a policy that provides coverage for prescription drugs shall provide 19 coverage for a brand name eligible prescription drug to an insured who 20 is already receiving such prescription drug as a generic equivalent or 21 has been diagnosed with or presented with a condition on or prior to the 22 start of the plan year that is treated by such eligible prescription 23 drug or is an eligible prescription drug that is or would be part of the 24 insured's treatment regimen for such condition. Such brand name eligible 25 prescription drug shall be covered at the same level of coverage as the EXPLANATION--Matter in italics (underscored) is new; matter in brackets [ ] is old law to be omitted. LBD03949-01-5 
 A. 1428 2 1 generic drug in the insurer's formulary until such time as the supply 2 issue is resolved and the drug has been removed from the federal food 3 and drug administration's shortage list. 4 § 2. Section 4329 of the insurance law is amended by adding a new 5 subsection (d) to read as follows: 6 (d) (1) As used in this subsection: 7 (A) "Eligible prescription drug" means a prescription drug approved 8 under 21 U.S.C. 355(c) that is not under patent. 9 (B) "Generic drug" means a drug that is approved pursuant to an appli- 10 cation referencing an eligible prescription drug that is submitted under 11 subsection (j) of Section 505 of the Federal Food, Drug, and Cosmetic 12 Act, 21 U.S.C. 355. 13 (C) "Supply issue" means a drug shortage or meaningful disruption as 14 defined in 21 U.S.C. 356(c). 15 (2) In the event an AB-rated generic equivalent or interchangeable 16 biological product for an eligible prescription drug is covered in an 17 insurer's formulary and such generic drug equivalent is unavailable due 18 to a supply issue which has been recognized by the federal food and drug 19 administration pursuant to 21 U.S.C. 356e and the dosage cannot be 20 adjusted, a corporation subject to the provisions of this article that 21 issues a contract that provides coverage for prescription drugs shall 22 provide coverage for a brand name eligible prescription drug to an 23 insured who is already receiving such prescription drug as a generic 24 equivalent or has been diagnosed with or presented with a condition on 25 or prior to the start of the plan year that is treated by such eligible 26 prescription drug or is an eligible prescription drug that is or would 27 be part of the insured's treatment regimen for such condition. Such 28 brand name eligible prescription drug shall be covered at the same level 29 of coverage as the generic drug in the insurer's formulary until such 30 time as the supply issue is resolved and the drug has been removed from 31 the federal food and drug administration's shortage list. 32 § 3. This act shall take effect immediately.