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

S T A T E   O F   N E W   Y O R K
        ________________________________________________________________________

                                          1428

                               2025-2026 Regular Sessions

                                  I N  A S S E M B L Y

                                     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.