S T A T E   O F   N E W   Y O R K
 ________________________________________________________________________
 
                                   9115
 
                           I N  A S S E M B L Y
 
                             January 21, 2020
                                ___________
 
 Introduced  by  M.  of  A. M. L. 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
 THE DRUG FOR A PARTICULAR INDICATION UNLESS THE DRUG IS  RECOGNIZED  FOR
 TREATMENT  OF THE INDICATION IN ONE OF THE STANDARD REFERENCE COMPENDIA,
 
  EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets
                       [ ] is old law to be omitted.
              

                                                            LBD14454-01-9

 A. 9115                             2
 
 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:
   (1)  "MEDICAL LITERATURE" MEANS PUBLISHED SCIENTIFIC STUDIES PUBLISHED
 IN ANY PEER-REVIEWED NATIONAL PROFESSIONAL JOURNAL.

 A. 9115                             3
 
   (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.