S T A T E O F N E W Y O R K
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3935
2021-2022 Regular Sessions
I N A S S E M B L Y
January 29, 2021
___________
Introduced by M. of A. M. MILLER -- read once and referred to the
Committee on Insurance
AN ACT to amend the insurance law and the public health law, in relation
to off-label drug usage
THE PEOPLE OF THE STATE OF NEW YORK, REPRESENTED IN SENATE AND ASSEM-
BLY, DO ENACT AS FOLLOWS:
Section 1. The insurance law is amended by adding a new section 3114
to read as follows:
§ 3114. OFF-LABEL DRUG USAGE. (A) AS USED IN THIS SECTION, THE FOLLOW-
ING TERMS SHALL HAVE THE FOLLOWING MEANINGS:
(1) "MEDICAL LITERATURE" MEANS PUBLISHED SCIENTIFIC STUDIES PUBLISHED
IN ANY PEER-REVIEWED NATIONAL PROFESSIONAL JOURNAL.
(2) "STANDARD REFERENCE COMPENDIA" MEANS:
(A) THE UNITED STATES PHARMACOPEIA DRUG INFORMATION;
(B) THE AMERICAN MEDICAL ASSOCIATION DRUG EVALUATIONS;
(C) THE AMERICAN HOSPITAL FORMULARY SERVICE DRUG INFORMATION;
(D) THE NATIONAL COMPREHENSIVE CANCER NETWORK DRUGS AND BIOLOGICS
COMPENDIUM;
(E) THE THOMSON MICROMEDEX DRUGDEX; OR
(F) THE GOLD STANDARD/ELSEVIER CLINICAL PHARMACOLOGY.
(B) (1) ANY CONTRACT OR OTHER ARRANGEMENT ENTERED INTO BY A HEALTH
INSURER OFFERING HEALTH INSURANCE UNDER THIS CHAPTER THAT PROVIDES
COVERAGE FOR DRUGS SHALL EXCLUDE COVERAGE OF ANY SUCH DRUG FOR A PARTIC-
ULAR INDICATION ON THE GROUND THAT THE DRUG HAS NOT BEEN APPROVED BY THE
UNITED STATES FOOD AND DRUG ADMINISTRATION FOR THAT INDICATION, IF THE
DRUG IS RECOGNIZED FOR TREATMENT OF THE INDICATION IN ONE OF THE STAND-
ARD REFERENCE COMPENDIA, IN THE MEDICAL LITERATURE OR HAS BEEN SUCCESS-
FULLY USED FOR TREATMENT PREVIOUSLY BY THE INSURED FOR THE SAME INDI-
CATION; PROVIDED, HOWEVER, THAT NOTHING IN THIS SECTION SHALL BE
CONSTRUED TO AUTHORIZE THE COMMISSIONER OF HEALTH TO APPROVE ANY DRUG OR
DIRECT ANY PERSON THAT ISSUES AN INSURANCE POLICY TO MAKE PAYMENTS FOR
EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets
[ ] is old law to be omitted.
LBD08666-01-1
A. 3935 2
THE DRUG FOR A PARTICULAR INDICATION UNLESS THE DRUG IS RECOGNIZED FOR
TREATMENT OF THE INDICATION IN ONE OF THE STANDARD REFERENCE COMPENDIA,
IN THE MEDICAL LITERATURE OR HAS BEEN SUCCESSFULLY USED FOR TREATMENT
PREVIOUSLY BY THE INSURED FOR THE SAME INDICATION.
(2) ANY COVERAGE OF A DRUG REQUIRED BY THIS SECTION SHALL ALSO INCLUDE
MEDICALLY NECESSARY SERVICES ASSOCIATED WITH THE ADMINISTRATION OF THE
DRUG.
(3) THIS SECTION SHALL NOT BE CONSTRUED TO ALTER EXISTING LAW WITH
REGARD TO PROVISIONS LIMITING THE COVERAGE OF DRUGS THAT HAVE NOT BEEN
APPROVED BY THE UNITED STATES FOOD AND DRUG ADMINISTRATION.
(4) THIS SECTION SHALL NOT BE CONSTRUED TO REQUIRE COVERAGE FOR ANY
DRUG WHEN THE UNITED STATES FOOD AND DRUG ADMINISTRATION HAS DETERMINED
ITS USE TO BE CONTRA-INDICATED.
(5) THIS SECTION SHALL NOT BE CONSTRUED TO REQUIRE COVERAGE FOR EXPER-
IMENTAL DRUGS NOT OTHERWISE APPROVED FOR ANY INDICATION BY THE UNITED
STATES FOOD AND DRUG ADMINISTRATION.
(6) ANY DISPUTE ABOUT COVERAGE FOR OFF-LABEL USES BROUGHT TO THE
COMMISSIONER OF HEALTH SHALL BE RESOLVED BY THE APPROPRIATE GRIEVANCE
PROCESS AUTHORIZED BY THE DEPARTMENT.
(7) THE COMMISSIONER OF HEALTH SHALL HAVE THE AUTHORITY TO DIRECT ANY
PERSON WHO ISSUES AN INSURANCE POLICY TO MAKE PAYMENTS REQUIRED BY THIS
SECTION.
§ 2. Subdivision 4 of section 280-a of the public health law is renum-
bered subdivision 5 and a new subdivision 4 is added to read as follows:
4. (A) NO PHARMACY BENEFIT MANAGER SHALL EXCLUDE COVERAGE OF ANY SUCH
DRUG FOR A PARTICULAR INDICATION ON THE GROUND THAT THE DRUG HAS NOT
BEEN APPROVED BY THE UNITED STATES FOOD AND DRUG ADMINISTRATION FOR THAT
INDICATION, IF THE DRUG IS RECOGNIZED FOR TREATMENT OF THE INDICATION IN
ONE OF THE STANDARD REFERENCE COMPENDIA, IN THE MEDICAL LITERATURE OR
HAS BEEN SUCCESSFULLY USED FOR TREATMENT PREVIOUSLY BY THE INSURED FOR
THE SAME INDICATION; PROVIDED, HOWEVER, THAT NOTHING IN THIS SUBDIVISION
SHALL BE CONSTRUED TO AUTHORIZE THE COMMISSIONER TO APPROVE ANY DRUG OR
DIRECT ANY PHARMACY BENEFIT MANAGER TO MAKE PAYMENTS FOR THE DRUG FOR A
PARTICULAR INDICATION UNLESS THE DRUG IS RECOGNIZED FOR TREATMENT OF THE
INDICATION IN ONE OF THE STANDARD REFERENCE COMPENDIA, IN THE MEDICAL
LITERATURE OR HAS BEEN SUCCESSFULLY USED FOR TREATMENT PREVIOUSLY BY THE
INSURED FOR THE SAME INDICATION.
(B) ANY COVERAGE OF A DRUG REQUIRED BY THIS SUBDIVISION SHALL ALSO
INCLUDE MEDICALLY NECESSARY SERVICES ASSOCIATED WITH THE ADMINISTRATION
OF THE DRUG.
(C) THIS SUBDIVISION SHALL NOT BE CONSTRUED TO ALTER EXISTING LAW WITH
REGARD TO PROVISIONS LIMITING THE COVERAGE OF DRUGS THAT HAVE NOT BEEN
APPROVED BY THE UNITED STATES FOOD AND DRUG ADMINISTRATION.
(D) THIS SUBDIVISION SHALL NOT BE CONSTRUED TO REQUIRE COVERAGE FOR
ANY DRUG WHEN THE UNITED STATES FOOD AND DRUG ADMINISTRATION HAS DETER-
MINED ITS USE TO BE CONTRA-INDICATED.
(E) THIS SUBDIVISION SHALL NOT BE CONSTRUED TO REQUIRE COVERAGE FOR
EXPERIMENTAL DRUGS NOT OTHERWISE APPROVED FOR ANY INDICATION BY THE
UNITED STATES FOOD AND DRUG ADMINISTRATION.
(F) ANY DISPUTE ABOUT COVERAGE FOR OFF-LABEL USES BROUGHT TO THE
COMMISSIONER SHALL BE RESOLVED BY THE APPROPRIATE GRIEVANCE PROCESS
AUTHORIZED BY THE DEPARTMENT.
(G) THE COMMISSIONER SHALL HAVE THE AUTHORITY TO DIRECT ANY PHARMACY
BENEFIT MANAGER TO MAKE PAYMENTS REQUIRED BY THIS SUBDIVISION.
(H) AS USED IN THIS SUBDIVISION, THE FOLLOWING TERMS SHALL HAVE THE
FOLLOWING MEANINGS:
A. 3935 3
(1) "MEDICAL LITERATURE" MEANS PUBLISHED SCIENTIFIC STUDIES PUBLISHED
IN ANY PEER-REVIEWED NATIONAL PROFESSIONAL JOURNAL.
(2) "STANDARD REFERENCE COMPENDIA" MEANS:
(A) THE UNITED STATES PHARMACOPEIA DRUG INFORMATION;
(B) THE AMERICAN MEDICAL ASSOCIATION DRUG EVALUATIONS;
(C) THE AMERICAN HOSPITAL FORMULARY SERVICE DRUG INFORMATION;
(D) THE NATIONAL COMPREHENSIVE CANCER NETWORK DRUGS AND BIOLOGICS
COMPENDIUM;
(E) THE THOMSON MICROMEDEX DRUGDEX; OR
(F) THE GOLD STANDARD/ELSEVIER CLINICAL PHARMACOLOGY.
§ 3. This act shall take effect on the ninetieth day after it shall
have become a law and shall apply to insurance policies issued, amended,
or renewed on or after such effective date.