S T A T E   O F   N E W   Y O R K
 ________________________________________________________________________
 
                                   8253
 
                        2019-2020 Regular Sessions
 
                           I N  A S S E M B L Y
 
                               June 10, 2019
                                ___________
 
 Introduced  by  M.  of  A. D. ROSENTHAL -- read once and referred to the
   Committee on Health
 
 AN ACT to amend the public health law, in relation to requiring  certain
   manufacturers  of  prescription  drugs  to notify the drug utilization
   review board of the proposed increase  of  the  wholesale  acquisition
   cost of such prescription drugs

   THE  PEOPLE OF THE STATE OF NEW YORK, REPRESENTED IN SENATE AND ASSEM-
 BLY, DO ENACT AS FOLLOWS:
 
   Section 1. The public health law is amended by adding  a  new  section
 277-a to read as follows:
   § 277-A. NOTIFICATION OF PRESCRIPTION DRUG PRICE INCREASES BY MANUFAC-
 TURERS.  1. THIS SECTION SHALL APPLY TO A MANUFACTURER OF A PRESCRIPTION
 DRUG THAT IS PURCHASED OR REIMBURSED BY ANY OF THE FOLLOWING:
   (A) AN INSURANCE COMPANY AUTHORIZED IN THIS STATE  TO  WRITE  ACCIDENT
 AND  HEALTH  INSURANCE,  A  COMPANY ORGANIZED PURSUANT TO ARTICLE FORTY-
 THREE OF THE INSURANCE LAW, A MUNICIPAL COOPERATIVE HEALTH BENEFIT  PLAN
 ESTABLISHED  PURSUANT  TO  ARTICLE  FORTY-SEVEN OF THE INSURANCE LAW, AN
 ORGANIZATION CERTIFIED PURSUANT TO ARTICLE FORTY-FOUR OF  THIS  CHAPTER,
 AN  INSTITUTION  OF  HIGHER  EDUCATION CERTIFIED PURSUANT TO SECTION ONE
 THOUSAND ONE HUNDRED TWENTY-FOUR OF THE INSURANCE LAW, OR THE  NEW  YORK
 STATE  HEALTH  INSURANCE  PLAN ESTABLISHED PURSUANT TO ARTICLE ELEVEN OF
 THE CIVIL SERVICE LAW; OR
   (B) A PHARMACY BENEFIT MANAGER, INCLUDING AN ENTITY THAT  DIRECTLY  OR
 THROUGH AN INTERMEDIARY, MANAGES THE PRESCRIPTION DRUG COVERAGE PROVIDED
 BY  A  HEALTH INSURER UNDER A CONTRACT OR POLICY DELIVERED OR ISSUED FOR
 DELIVERY IN THIS STATE OR A HEALTH PLAN SUBJECT TO SECTION THREE HUNDRED
 SIXTY-FOUR-J OF THE SOCIAL SERVICES LAW, INCLUDING  THE  PROCESSING  AND
 PAYMENT OF CLAIMS FOR PRESCRIPTION DRUGS, THE PERFORMANCE OF DRUG UTILI-
 ZATION  REVIEW, THE PROCESSING OF DRUG PRIOR AUTHORIZATION REQUESTS, THE
 ADJUDICATION OF APPEALS  OR  GRIEVANCES  RELATED  TO  PRESCRIPTION  DRUG
 
  EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets
                       [ ] is old law to be omitted.
                                                            LBD11426-01-9
              

 A. 8253                             2
 
 COVERAGE,  CONTRACTING WITH NETWORK PHARMACIES, AND CONTROLLING THE COST
 OF COVERED PRESCRIPTION DRUGS.
   2. (A) A MANUFACTURER OF A PRESCRIPTION DRUG WITH A WHOLESALE ACQUISI-
 TION COST OF MORE THAN FORTY DOLLARS FOR A COURSE OF THERAPY SHALL NOTI-
 FY  THE  DRUG  UTILIZATION REVIEW BOARD IF THE INCREASE IN THE WHOLESALE
 ACQUISITION COST OF SUCH PRESCRIPTION DRUG IS  MORE  THAN  TEN  PERCENT,
 INCLUDING  THE  PROPOSED  INCREASE  AND  THE  CUMULATIVE  INCREASES THAT
 OCCURRED WITHIN THE PREVIOUS TWO CALENDAR YEARS  PRIOR  TO  THE  CURRENT
 YEAR.  FOR PURPOSES OF THIS SECTION, A "COURSE OF THERAPY" IS DEFINED AS
 EITHER OF THE FOLLOWING:
   (I) THE RECOMMENDED DAILY DOSAGE UNITS OF A PRESCRIPTION DRUG PURSUANT
 TO ITS PRESCRIBING LABEL AS APPROVED BY THE FEDERAL FOOD AND DRUG ADMIN-
 ISTRATION FOR THIRTY DAYS; OR
   (II) THE RECOMMENDED DAILY DOSAGE UNITS OF A PRESCRIPTION DRUG  PURSU-
 ANT  TO  ITS  PRESCRIBING LABEL AS APPROVED BY THE FEDERAL FOOD AND DRUG
 ADMINISTRATION FOR A NORMAL COURSE OF TREATMENT THAT IS LESS THAN THIRTY
 DAYS.
   (B) THE NOTICE REQUIRED BY PARAGRAPH (A) OF THIS SUBDIVISION SHALL  BE
 PROVIDED  IN WRITING TO THE DRUG UTILIZATION REVIEW BOARD AT LEAST SIXTY
 DAYS PRIOR TO THE PLANNED EFFECTIVE DATE OF THE INCREASE.
   (C) (I) THE NOTICE REQUIRED BY PARAGRAPH (A) OF THIS SUBDIVISION SHALL
 INCLUDE THE DATE OF THE INCREASE, THE CURRENT WHOLESALE ACQUISITION COST
 OF THE PRESCRIPTION DRUG, AND THE DOLLAR AMOUNT OF THE  FUTURE  INCREASE
 IN THE WHOLESALE ACQUISITION COST OF THE PRESCRIPTION DRUG.
   (II)  THE  NOTICE  REQUIRED BY PARAGRAPH (A) OF THIS SUBDIVISION SHALL
 INCLUDE A STATEMENT REGARDING WHETHER A CHANGE  OR  IMPROVEMENT  IN  THE
 DRUG  NECESSITATES  THE  PRICE  INCREASE.  IF SO, THE MANUFACTURER SHALL
 DESCRIBE THE CHANGE OR IMPROVEMENT.
   (D) IN THE EVENT THAT A MANUFACTURER OF A PRESCRIPTION DRUG SUBJECT TO
 THIS SECTION DOES NOT REPORT THE INFORMATION REQUIRED IN  PARAGRAPH  (A)
 OF  THIS  SUBDIVISION,  THE  COMMISSIONER  IS AUTHORIZED TO LEVY A CIVIL
 PENALTY, AFTER NOTICE AND A HEARING, AGAINST SUCH MANUFACTURER OF UP  TO
 ONE  THOUSAND  DOLLARS  PER DAY FOR EVERY DAY AFTER THE REPORTING PERIOD
 DESCRIBED IN THIS SECTION THAT THE REQUIRED INFORMATION IS NOT REPORTED.
   § 2. This act shall take effect immediately.