Senate Bill S599A

                             
                     S T A T E   O F   N E W   Y O R K
 ________________________________________________________________________
 
                                  599--A
     Cal. No. 75
 
                        2023-2024 Regular Sessions
 
                             I N  S E N A T E
 
                              January 5, 2023
                                ___________
 
 Introduced by Sens. SALAZAR, ADDABBO, LIU, MAY -- read twice and ordered
   printed,  and  when printed to be committed to the Committee on Health
   -- reported favorably from said committee and committed to the Commit-
   tee on Rules -- reported favorably from said committee, ordered  to  a
   third  reading,  passed  by  Senate  and  delivered  to  the Assembly,
   recalled, vote reconsidered, restored to third  reading,  amended  and
   ordered reprinted, retaining its place in the order of third reading
 
 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
 
  EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets
                       [ ] is old law to be omitted.
              

                                                            LBD00641-03-3
 S. 599--A                           2
 
 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
 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 SIXTEEN  PERCENT,  INCLUDING  THE
 PROPOSED  INCREASE AND THE CUMULATIVE INCREASES THAT OCCURRED WITHIN THE
 PREVIOUS TWENTY-FOUR MONTHS PRIOR TO THE PLANNED EFFECTIVE DATE  OF  THE
 INCREASE.    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 ONE 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 ONE OF THIS SUBSECTION ON THE DEPARTMENT OF FINANCIAL SERVICES
 WEBSITE WITHIN FIVE DAYS OF ITS RECEIPT.
   (3) (I) THE NOTICE REQUIRED BY PARAGRAPH ONE 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 ONE  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 REASONABLY DESIGNATED AS A TRADE SECRET  SHALL
 BE  CONSIDERED  CONFIDENTIAL  AND  A  TRADE SECRET, SHALL BE EXEMPT FROM
 PUBLIC DISCLOSURE AND COPYING UNDER ARTICLE SIX OF THE  PUBLIC  OFFICERS
 LAW AND SHALL NOT BE DISCLOSED DIRECTLY OR INDIRECTLY BY THE SUPERINTEN-
 DENT.  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 MANUFACTURER'S PRESCRIPTION  DRUG
 THAT HAS BEEN REASONABLY 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 ONE
 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
 S. 599--A                           3
 
 FOR  EVERY DAY AFTER THE REPORTING PERIOD DESCRIBED IN THIS SECTION THAT
 THE REQUIRED INFORMATION IS NOT REPORTED.
   § 2. This act shall take effect on the one hundred eightieth day after
 it shall have become a law.