S T A T E O F N E W Y O R K
________________________________________________________________________
11256
I N A S S E M B L Y
May 4, 2026
___________
Introduced by M. of A. JENSEN -- read once and referred to the Committee
on Insurance
AN ACT to amend the insurance law, in relation to requiring health plan
coverage to include certain generic drugs and biosimilars
THE PEOPLE OF THE STATE OF NEW YORK, REPRESENTED IN SENATE AND ASSEM-
BLY, DO ENACT AS FOLLOWS:
Section 1. Section 3242 of the insurance law is amended by adding a
new subsection (d) to read as follows:
(D) (1) FOR THE PURPOSES OF THIS SUBSECTION, THE FOLLOWING TERMS SHALL
HAVE THE FOLLOWING MEANINGS:
(A) "BIOSIMILAR" MEANS ANY BIOLOGICAL PRODUCT THAT IS LICENSED UNDER
42 U.S.C.§ 262(K) AND HAS BEEN LISTED IN THE FDA'S DATABASE OF LICENSED
BIOLOGICAL PRODUCTS, COMMONLY REFERRED TO AS THE PURPLE BOOK, AS BIOSI-
MILAR TO OR INTERCHANGEABLE WITH A REFERENCE BIOLOGICAL PRODUCT.
(B) "BRAND DRUG" MEANS A DRUG FOR WHICH AN APPLICATION HAS BEEN
APPROVED UNDER 21 U.S.C. § 355(C), OR A BIOLOGICAL PRODUCT, OTHER THAN A
BIOSIMILAR, THAT IS LICENSED UNDER 42 U.S.C. § 262(A).
(C) "FDA" MEANS THE U.S. FOOD AND DRUG ADMINISTRATION.
(D) "FORMULARY" MEANS A LIST OF PRESCRIPTION DRUGS THAT IS DEVELOPED
BY A PHARMACY AND THERAPEUTICS COMMITTEE OR OTHER CLINICAL AND PHARMACY
EXPERTS AND REPRESENTS A POLICY'S PRESCRIPTION DRUGS APPROVED FOR USE.
(E) "GENERIC DRUG" MEANS A DRUG FOR WHICH AN APPLICATION HAS BEEN
APPROVED UNDER 21 U.S.C. §355(J) AND WHICH HAS BEEN LISTED IN THE FDA'S
APPROVED DRUG PRODUCTS WITH THERAPEUTIC EQUIVALENCE EVALUATIONS, COMMON-
LY REFERRED TO AS THE ORANGE BOOK, AS THERAPEUTICALLY EQUIVALENT TO A
REFERENCE DRUG, EVEN IF THE MANUFACTURER OF SUCH DRUG APPLIES A TRADE
NAME TO THE DRUG.
(F) "POLICY" MEANS A POLICY DELIVERED OR ISSUED FOR DELIVERY IN THIS
STATE THAT PROVIDES COVERAGE FOR PRESCRIPTION DRUGS.
(G) "REFERENCE LISTED DRUG" IS THE LISTED DRUG IDENTIFIED BY THE FDA
AS THE DRUG PRODUCT UPON WHICH AN APPLICANT RELIES IN SEEKING APPROVAL
OF ITS APPLICATION SUBMITTED UNDER 21 U.S.C. §355(J).
(H) "REFERENCE PRODUCT" IS A SINGLE BIOLOGICAL PRODUCT, LICENSED BY
THE FDA UNDER 42 U.S.C. § 262(A), AGAINST WHICH A PROPOSED BIOSIMILAR OR
EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets
[ ] is old law to be omitted.
LBD14739-01-6
A. 11256 2
INTERCHANGEABLE PRODUCT IS COMPARED, AND LISTED AS A REFERENCE PRODUCT
IN THE FDA'S DATABASE OF LICENSED BIOLOGICAL PRODUCTS, COMMONLY REFERRED
TO AS THE PURPLE BOOK.
(I) "WHOLESALE ACQUISITION COST" HAS THE SAME MEANING AS DEFINED BY 42
U.S.C. § 1395W-3A(C)(6)(B).
(2) (A) IF A GENERIC DRUG IS APPROVED BY THE FDA, IS MARKETED PURSUANT
TO SUCH APPROVAL, AND HAS A WHOLESALE ACQUISITION COST THAT IS LESS THAN
THE WHOLESALE ACQUISITION COST OF THE REFERENCE LISTED DRUG ON SUCH
GENERIC DRUG'S INITIAL DATE OF MARKETING, THEN POLICIES THAT PROVIDE
COVERAGE FOR SUCH GENERIC DRUG'S REFERENCE LISTED DRUG AT THE TIME OF
SUCH GENERIC DRUG'S MARKETING DATE SHALL:
(I) IMMEDIATELY MAKE SUCH GENERIC DRUG AVAILABLE ON THE FORMULARY WITH
MORE FAVORABLE COST SHARING, INCLUDING ACTUAL OUT-OF-POCKET COSTS, RELA-
TIVE TO SUCH REFERENCE LISTED DRUG; AND
(II) NOT IMPOSE ANY PRIOR AUTHORIZATION, STEP THERAPY, OR OTHER LIMI-
TATION ON COVERAGE OF A GENERIC DRUG FOR WHICH FORMULARY PLACEMENT IS
REQUIRED UNDER CLAUSE (I) OF THIS SUBPARAGRAPH, NOR IMPOSE ANY
RESTRICTION ON A PHARMACY THROUGH WHICH AN ENROLLEE MAY OBTAIN SUCH
GENERIC DRUG, THAT MAKES IT MORE DIFFICULT FOR AN ENROLLEE TO OBTAIN
COVERAGE OF OR ACCESS TO SUCH GENERIC DRUG THAN THE REFERENCE LISTED
DRUG.
(B) THE PROVISIONS OF SUBPARAGRAPH (A) OF THIS PARAGRAPH SHALL APPLY
AS LONG AS THE WHOLESALE ACQUISITION COST OF THE GENERIC DRUG IS LOWER
THAN THE WHOLESALE ACQUISITION COST OF THE REFERENCE LISTED DRUG.
(3) (A) IF A BIOSIMILAR IS LICENSED BY THE FDA, IS MARKETED PURSUANT
TO SUCH LICENSURE, AND HAS A WHOLESALE ACQUISITION COST THAT IS LESS
THAN THE WHOLESALE ACQUISITION COST OF THE REFERENCE PRODUCT OF SUCH
BIOSIMILAR ON THE INITIAL DATE OF MARKETING, THEN POLICIES THAT PROVIDE
COVERAGE FOR SUCH BIOSIMILAR'S REFERENCE PRODUCT AT THE TIME OF SUCH
BIOSIMILAR'S MARKETING DATE SHALL:
(I) IMMEDIATELY MAKE AT LEAST ONE BIOSIMILAR AVAILABLE ON THE FORMU-
LARY ON A TIER WITH MORE FAVORABLE COST SHARING, INCLUDING ACTUAL OUT-
OF-POCKET COSTS, RELATIVE TO THE REFERENCE PRODUCT; AND
(II) NOT IMPOSE ANY PRIOR AUTHORIZATION, STEP THERAPY, OR OTHER LIMI-
TATION ON COVERAGE OF A BIOSIMILAR FOR WHICH FORMULARY PLACEMENT IS
REQUIRED UNDER CLAUSE (I) OF THIS SUBPARAGRAPH, NOR IMPOSE ANY
RESTRICTION ON A PHARMACY THROUGH WHICH AN ENROLLEE MAY OBTAIN SUCH
BIOSIMILAR, THAT MAKES IT MORE DIFFICULT FOR AN ENROLLEE TO OBTAIN
COVERAGE OF OR ACCESS TO SUCH BIOSIMILAR THAN THE REFERENCE PRODUCT.
(B) SUBPARAGRAPH (A) OF THIS PARAGRAPH SHALL APPLY AS LONG AS THE
WHOLESALE ACQUISITION COST OF THE BIOSIMILAR IS LOWER THAN THE WHOLESALE
ACQUISITION COST OF THE REFERENCE PRODUCT.
(4) NOTHING IN THIS SUBSECTION SHALL REQUIRE A POLICY TO CONTINUE
PROVIDING COVERAGE FOR A BRAND DRUG AFTER A GENERIC DRUG OR BIOSIMILAR
IS APPROVED OR LICENSED, AS APPLICABLE, AND MARKETED.
(5) NOTHING IN THIS SUBSECTION SHALL REQUIRE A POLICY TO PROVIDE
COVERAGE FOR A BRAND DRUG, GENERIC DRUG, OR BIOSIMILAR IF THE CLINICAL
AND PHARMACY EXPERTS THAT DEVELOP SUCH POLICY'S FORMULARY DETERMINE THAT
SUCH DRUG OR BIOSIMILAR IS NO LONGER MEDICALLY APPROPRIATE OR COST-EF-
FECTIVE.
(6) THE SUPERINTENDENT SHALL BE AUTHORIZED TO PROMULGATE ANY RULES
AND/OR REGULATIONS NECESSARY TO EFFECTUATE THE PROVISIONS OF THIS
SUBSECTION.
§ 2. Section 4329 of the insurance law is amended by adding a new
subsection (d) to read as follows:
A. 11256 3
(D) (1) FOR THE PURPOSES OF THIS SUBSECTION, THE FOLLOWING TERMS SHALL
HAVE THE FOLLOWING MEANINGS:
(A) "BIOSIMILAR" MEANS ANY BIOLOGICAL PRODUCT THAT IS LICENSED UNDER
42 U.S.C.§ 262(K) AND HAS BEEN LISTED IN THE FDA'S DATABASE OF LICENSED
BIOLOGICAL PRODUCTS, COMMONLY REFERRED TO AS THE PURPLE BOOK, AS BIOSI-
MILAR TO OR INTERCHANGEABLE WITH A REFERENCE BIOLOGICAL PRODUCT.
(B) "BRAND DRUG" MEANS A DRUG FOR WHICH AN APPLICATION HAS BEEN
APPROVED UNDER 21 U.S.C. § 355(C), OR A BIOLOGICAL PRODUCT, OTHER THAN A
BIOSIMILAR, THAT IS LICENSED UNDER 42 U.S.C. § 262(A).
(C) "FDA" MEANS THE U.S. FOOD AND DRUG ADMINISTRATION.
(D) "FORMULARY" MEANS A LIST OF PRESCRIPTION DRUGS THAT IS DEVELOPED
BY A PHARMACY AND THERAPEUTICS COMMITTEE OR OTHER CLINICAL AND PHARMACY
EXPERTS AND REPRESENTS A PLAN'S PRESCRIPTION DRUGS APPROVED FOR USE.
(E) "GENERIC DRUG" MEANS A DRUG FOR WHICH AN APPLICATION HAS BEEN
APPROVED UNDER 21 U.S.C. § 355(J) AND WHICH HAS BEEN LISTED IN THE FDA'S
APPROVED DRUG PRODUCTS WITH THERAPEUTIC EQUIVALENCE EVALUATIONS, COMMON-
LY REFERRED TO AS THE ORANGE BOOK, AS THERAPEUTICALLY EQUIVALENT TO A
REFERENCE DRUG, EVEN IF THE MANUFACTURER OF SUCH DRUG APPLIES A TRADE
NAME TO THE DRUG.
(F) "PLAN" MEANS A CONTRACT ISSUED BY A CORPORATION SUBJECT TO THE
PROVISIONS OF THIS ARTICLE THAT PROVIDES COVERAGE FOR PRESCRIPTION
DRUGS.
(G) "REFERENCE LISTED DRUG" IS THE LISTED DRUG IDENTIFIED BY THE FDA
AS THE DRUG PRODUCT UPON WHICH AN APPLICANT RELIES IN SEEKING APPROVAL
OF ITS APPLICATION SUBMITTED UNDER 21 U.S.C. § 355(J).
(H) "REFERENCE PRODUCT" IS A SINGLE BIOLOGICAL PRODUCT, LICENSED BY
THE FDA UNDER 42 U.S.C. § 262(A), AGAINST WHICH A PROPOSED BIOSIMILAR OR
INTERCHANGEABLE PRODUCT IS COMPARED, AND LISTED AS A REFERENCE PRODUCT
IN THE FDA'S DATABASE OF LICENSED BIOLOGICAL PRODUCTS, COMMONLY REFERRED
TO AS THE PURPLE BOOK.
(I) "WHOLESALE ACQUISITION COST" HAS THE SAME MEANING AS DEFINED BY 42
U.S.C. § 1395W-3A(C)(6)(B).
(2) (A) IF A GENERIC DRUG IS APPROVED BY THE FDA, IS MARKETED PURSUANT
TO SUCH APPROVAL, AND HAS A WHOLESALE ACQUISITION COST THAT IS LESS THAN
THE WHOLESALE ACQUISITION COST OF THE REFERENCE LISTED DRUG ON SUCH
GENERIC DRUG'S INITIAL DATE OF MARKETING, THEN PLANS THAT PROVIDE COVER-
AGE FOR SUCH GENERIC DRUG'S REFERENCE LISTED DRUG AT THE TIME OF SUCH
GENERIC DRUG'S MARKETING DATE SHALL:
(I) IMMEDIATELY MAKE SUCH GENERIC DRUG AVAILABLE ON THE FORMULARY WITH
MORE FAVORABLE COST SHARING, INCLUDING ACTUAL OUT-OF-POCKET COSTS, RELA-
TIVE TO SUCH REFERENCE LISTED DRUG; AND
(II) NOT IMPOSE ANY PRIOR AUTHORIZATION, STEP THERAPY, OR OTHER LIMI-
TATION ON COVERAGE OF A GENERIC DRUG FOR WHICH FORMULARY PLACEMENT IS
REQUIRED UNDER CLAUSE (I) OF THIS SUBPARAGRAPH, NOR IMPOSE ANY
RESTRICTION ON A PHARMACY THROUGH WHICH AN ENROLLEE MAY OBTAIN SUCH
GENERIC DRUG, THAT MAKES IT MORE DIFFICULT FOR AN ENROLLEE TO OBTAIN
COVERAGE OF OR ACCESS TO SUCH GENERIC DRUG THAN THE REFERENCE LISTED
DRUG.
(B) THE PROVISIONS OF SUBPARAGRAPH (A) OF THIS PARAGRAPH SHALL APPLY
AS LONG AS THE WHOLESALE ACQUISITION COST OF THE GENERIC DRUG IS LOWER
THAN THE WHOLESALE ACQUISITION COST OF THE REFERENCE LISTED DRUG.
(3) (A) IF A BIOSIMILAR IS LICENSED BY THE FDA, IS MARKETED PURSUANT
TO SUCH LICENSURE, AND HAS A WHOLESALE ACQUISITION COST THAT IS LESS
THAN THE WHOLESALE ACQUISITION COST OF THE REFERENCE PRODUCT OF SUCH
BIOSIMILAR ON THE INITIAL DATE OF MARKETING, THEN PLANS THAT PROVIDE
A. 11256 4
COVERAGE FOR SUCH BIOSIMILAR'S REFERENCE PRODUCT AT THE TIME OF SUCH
BIOSIMILAR'S MARKETING DATE SHALL:
(I) IMMEDIATELY MAKE AT LEAST ONE BIOSIMILAR AVAILABLE ON THE FORMU-
LARY ON A TIER WITH MORE FAVORABLE COST SHARING, INCLUDING ACTUAL OUT-
OF-POCKET COSTS, RELATIVE TO THE REFERENCE PRODUCT; AND
(II) NOT IMPOSE ANY PRIOR AUTHORIZATION, STEP THERAPY, OR OTHER LIMI-
TATION ON COVERAGE OF A BIOSIMILAR FOR WHICH FORMULARY PLACEMENT IS
REQUIRED UNDER CLAUSE (I) OF THIS SUBPARAGRAPH, NOR IMPOSE ANY
RESTRICTION ON A PHARMACY THROUGH WHICH AN ENROLLEE MAY OBTAIN SUCH
BIOSIMILAR, THAT MAKES IT MORE DIFFICULT FOR AN ENROLLEE TO OBTAIN
COVERAGE OF OR ACCESS TO SUCH BIOSIMILAR THAN THE REFERENCE PRODUCT.
(B) SUBPARAGRAPH (A) OF THIS PARAGRAPH SHALL APPLY AS LONG AS THE
WHOLESALE ACQUISITION COST OF THE BIOSIMILAR IS LOWER THAN THE WHOLESALE
ACQUISITION COST OF THE REFERENCE PRODUCT.
(4) NOTHING IN THIS SUBSECTION SHALL REQUIRE A PLAN TO CONTINUE
PROVIDING COVERAGE FOR A BRAND DRUG AFTER A GENERIC DRUG OR BIOSIMILAR
IS APPROVED OR LICENSED, AS APPLICABLE, AND MARKETED.
(5) NOTHING IN THIS SUBSECTION SHALL REQUIRE A PLAN TO PROVIDE COVER-
AGE FOR A BRAND DRUG, GENERIC DRUG, OR BIOSIMILAR IF THE CLINICAL AND
PHARMACY EXPERTS THAT DEVELOP SUCH PLAN'S FORMULARY DETERMINE THAT SUCH
DRUG OR BIOSIMILAR IS NO LONGER MEDICALLY APPROPRIATE OR COST-EFFECTIVE.
(6) THE SUPERINTENDENT SHALL BE AUTHORIZED TO PROMULGATE ANY RULES
AND/OR REGULATIONS NECESSARY TO EFFECTUATE THE PROVISIONS OF THIS
SUBSECTION.
§ 3. This act shall take effect on the first of January next succeed-
ing the date on which it shall have become a law, and shall apply to
policies and contracts issued, renewed or amended on or after such
effective date. Effective immediately, the addition, amendment and/or
repeal of any rule or regulation necessary for the implementation of
this act on its effective date are authorized to be made and completed
on or before such effective date.