S T A T E   O F   N E W   Y O R K
 ________________________________________________________________________
 
                                    663
 
                        2021-2022 Regular Sessions
 
                           I N  A S S E M B L Y
 
                                (PREFILED)
 
                              January 6, 2021
                                ___________
 
 Introduced   by  M.  of  A.  D. ROSENTHAL,  DICKENS,  COLTON,  WILLIAMS,
   SEAWRIGHT, COOK, O'DONNELL, SIMON, ABINANTI, JACOBSON  --  Multi-Spon-
   sored  by  --  M. of A.  GALEF, SALKA -- 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-
 
  EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets
              

                       [ ] is old law to be omitted.
                                                            LBD05130-01-1

 A. 663                              2
 
 ZATION  REVIEW, THE PROCESSING OF DRUG PRIOR AUTHORIZATION REQUESTS, THE
 ADJUDICATION OF APPEALS  OR  GRIEVANCES  RELATED  TO  PRESCRIPTION  DRUG
 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.

                             
                     S T A T E   O F   N E W   Y O R K
 ________________________________________________________________________
 
                                  663--B
 
                        2021-2022 Regular Sessions
 
                           I N  A S S E M B L Y
 
                                (PREFILED)
 
                              January 6, 2021
                                ___________
 
 Introduced   by  M.  of  A.  D. ROSENTHAL,  DICKENS,  COLTON,  WILLIAMS,
   SEAWRIGHT, COOK, O'DONNELL,  SIMON,  ABINANTI,  JACOBSON,  GRIFFIN  --
   Multi-Sponsored  by -- M. of A. GALEF, SALKA -- read once and referred
   to the Committee on Health -- recommitted to the Committee  on  Health
   in  accordance  with  Assembly Rule 3, sec. 2 -- committee discharged,
   bill amended, ordered reprinted as amended  and  recommitted  to  said
   committee  --  again  reported  from  said  committee with amendments,
   ordered reprinted as amended and recommitted to said committee
 
 AN ACT to amend the insurance law,  in  relation  to  requiring  certain
   manufacturers  of  prescription  drugs to notify the superintendant of
   any 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 insurance law is amended by adding a new section  111-a
 to read as follows:
   § 111-A. NOTIFICATION OF PRESCRIPTION DRUG PRICE INCREASES BY MANUFAC-
 TURERS. (A) THIS SECTION SHALL APPLY TO A MANUFACTURER OF A PRESCRIPTION
 DRUG THAT IS PURCHASED OR REIMBURSED IN THIS STATE BY ANY OF THE FOLLOW-
 ING:
   (1)  AN  INSURANCE  COMPANY AUTHORIZED IN THIS STATE TO WRITE ACCIDENT
 AND HEALTH INSURANCE, A COMPANY ORGANIZED  PURSUANT  TO  ARTICLE  FORTY-
 THREE  OF  THIS  CHAPTER,  A  MUNICIPAL  COOPERATIVE HEALTH BENEFIT PLAN
 ESTABLISHED PURSUANT TO ARTICLE FORTY-SEVEN OF THIS CHAPTER,  AN  ORGAN-
 IZATION  CERTIFIED  PURSUANT  TO ARTICLE FORTY-FOUR OF THE PUBLIC HEALTH
 LAW, AN INSTITUTION OF HIGHER EDUCATION CERTIFIED  PURSUANT  TO  SECTION
 ONE  THOUSAND  ONE  HUNDRED TWENTY-FOUR OF THIS CHAPTER, OR THE NEW YORK
 STATE HEALTH INSURANCE PLAN ESTABLISHED PURSUANT TO  ARTICLE  ELEVEN  OF
 THE CIVIL SERVICE LAW; OR
   (2)  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
              

 
  EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets
                       [ ] is old law to be omitted.
                                                            LBD05130-05-2
 A. 663--B                           2
 
 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
 COVERAGE, CONTRACTING WITH NETWORK PHARMACIES, AND CONTROLLING THE  COST
 OF COVERED PRESCRIPTION DRUGS.
   (B)  (1) A MANUFACTURER OF A PRESCRIPTION DRUG WITH A WHOLESALE ACQUI-
 SITION COST OF MORE THAN FORTY DOLLARS FOR A  COURSE  OF  THERAPY  SHALL
 NOTIFY THE SUPERINTENDENT, HIS OR HER DEPUTY OR OTHER OFFICER DESIGNATED
 BY THE SUPERINTENDENT, 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  TWENTY-FOUR MONTHS. 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.
   (2) (I) THE NOTICE REQUIRED BY PARAGRAPH (1) OF THIS SUBSECTION  SHALL
 BE  PROVIDED  IN WRITING TO THE SUPERINTENDENT AT LEAST SIXTY DAYS PRIOR
 TO THE PLANNED EFFECTIVE DATE OF THE  INCREASE  AND  SHALL  INCLUDE  THE
 PROPOSED  INCREASE AND THE CUMULATIVE INCREASES THAT OCCURRED WITHIN THE
 PREVIOUS TWENTY-FOUR MONTHS.
   (II) THE SUPERINTENDENT SHALL FORTHWITH PUBLISH THE NOTICE REQUIRED BY
 PARAGRAPH (A)  OF  THIS  SUBDIVISION  ON  THE  DEPARTMENT  OF  FINANCIAL
 SERVICES WEBSITE WITHIN FIVE DAYS OF ITS RECEIPT.
   (3)  (I) THE NOTICE REQUIRED BY PARAGRAPH (1) OF THIS SUBSECTION 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 (1) OF THIS SUBSECTION 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.
   (4) INFORMATION SUPPLIED BY A MANUFACTURER PURSUANT  TO  THIS  SECTION
 THAT  THE MANUFACTURER HAS DESIGNATED AS A TRADE SECRET SHALL BE CONSID-
 ERED CONFIDENTIAL AND A TRADE SECRET AND SHALL NOT BE DISCLOSED DIRECTLY
 OR INDIRECTLY  BY  THE  SUPERINTENDENT.  NOTWITHSTANDING  THE  FOREGOING
 SENTENCE,  THE SUPERINTENDENT SHALL BE PERMITTED TO DISCLOSE INFORMATION
 IN AN AGGREGATED FORMAT IF SUCH AGGREGATE INFORMATION CANNOT DIRECTLY OR
 INDIRECTLY BE USED TO IDENTIFY TRADE SECRET  INFORMATION  RELATED  TO  A
 SPECIFIC MANUFACTURER OR THE MANUFACTURER'S PRESCRIPTION DRUG, INCLUDING
 BUT  NOT  LIMITED TO ANY INFORMATION RELATED TO PRICING FOR THE MANUFAC-
 TURER'S PRESCRIPTION DRUG THAT HAS BEEN DESIGNATED AS A TRADE SECRET.
   (5) IN THE EVENT THAT A MANUFACTURER OF A PRESCRIPTION DRUG SUBJECT TO
 THIS SECTION DOES NOT REPORT THE INFORMATION REQUIRED IN  PARAGRAPH  (1)
 OF  THIS  SUBSECTION,  THE  SUPERINTENDENT  IS  AUTHORIZED TO IMPOSE ANY
 PENALTY OR REMEDY AUTHORIZED BY THIS CHAPTER, AFTER NOTICE AND  A  HEAR-
 ING,  AGAINST  SUCH  MANUFACTURER OF UP TO FIVE 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.