The New York State Senate

 
                     S T A T E   O F   N E W   Y O R K
 ________________________________________________________________________
 
                                   1707
 
                        2023-2024 Regular Sessions
 
                           I N  A S S E M B L Y
 
                             January 18, 2023
                                ___________
 
 Introduced   by  M.  of  A.  D. ROSENTHAL,  DICKENS,  COLTON,  WILLIAMS,
   SEAWRIGHT, COOK, SIMON, JACOBSON -- read  once  and  referred  to  the
   Committee on Health
 
 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
 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
 
  EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets
                       [ ] is old law to be omitted.
                                                            LBD00641-01-3

 A. 1707                             2
 
 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.