S 8380

                     S T A T E   O F   N E W   Y O R K
 ________________________________________________________________________
                                   8380
                        2025-2026 Regular Sessions
                             I N  S E N A T E
                               June 6, 2025
                                ___________
 Introduced  by  Sen.  BYNOE  -- read twice and ordered printed, and when
   printed to be committed to the Committee on Rules
 AN ACT to amend the public health law, in relation to  requiring  trans-
   parency requirements for certain 340B 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
 280-d to read as follows:
   § 280-D. ACCOUNTABILITY TO SAFEGUARD BENEFITS FOR VULNERABLE PATIENTS.
 1.  FOR THE PURPOSES OF THIS SECTION, THE FOLLOWING TERMS SHALL HAVE THE
 FOLLOWING MEANINGS:
   (A) "340B DRUG" SHALL MEAN A COVERED OUTPATIENT DRUG, AS DEFINED BY 42
 USC § 1396R-8(K)(2), THAT HAS BEEN SUBJECT  TO  ANY  OFFER  FOR  REDUCED
 PRICES  BY  A  MANUFACTURER  PURSUANT  TO  42  USC  § 256B(A)(1), AND IS
 PURCHASED BY A COVERED ENTITY.
   (B) "340B  PROFITS"  SHALL  MEAN  THE  DIFFERENCE  BETWEEN  AGGREGATED
 PAYMENTS RECEIVED FROM INSURERS, PAYORS, OR SELF-PAYING PATIENTS FOR ALL
 340B DRUGS AND THE AGGREGATE ACQUISITION COST PAY FOR ALL 340B DRUGS.
   (C)  "340B  PROGRAM"  SHALL  MEAN  THE  FEDERAL  DRUG  PRICING PROGRAM
 DESCRIBED IN 42 USC § 256B.
   (D) "CHARITY CARE" SHALL HAVE THE SAME MEANING  AS  ASCRIBED  TO  SUCH
 TERM  AS  IS  FOUND IN LINE TWENTY-THREE OF THE S-10 MEDICARE COST WORK-
 SHEET OR ANY SUCCESSOR FORM.
   (E) "CONTRACT PHARMACY" SHALL MEAN A PHARMACY  WITH  WHICH  A  COVERED
 ENTITY  HAS  CONTRACTED TO DISPENSE 340B DRUGS ON BEHALF OF SUCH COVERED
 ENTITY TO PATIENTS  OF  SUCH  COVERED  ENTITY,  WHETHER  DISTRIBUTED  IN
 PERSON, VIA MAIL, OR BY OTHER MEANS.
   (F)  "COVERED  ENTITY"  SHALL  HAVE THE SAME MEANING AS UNDER 42 USC §
 256B(A)(4).
  EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets
                       [ ] is old law to be omitted.
                                                            LBD10744-01-5
 S. 8380                             2
   (G) "LOW-INCOME PATIENT" SHALL MEAN A PATIENT OF A COVERED ENTITY WITH
 A FAMILY INCOME BELOW TWO HUNDRED PERCENT OF THE FEDERAL POVERTY  GUIDE-
 LINES.
   2. BEGINNING APRIL FIRST, TWO THOUSAND TWENTY-SIX, EACH COVERED ENTITY
 SHALL  REPORT  TO THE DEPARTMENT WITH RESPECT TO SUCH COVERED ENTITY AND
 SEPARATELY FOR EACH OFFSITE OUTPATIENT  FACILITY  ASSOCIATED  WITH  SUCH
 COVERED  ENTITY,  IN  A FORM AND MANNER AS DETERMINED BY THE DEPARTMENT,
 THE FOLLOWING INFORMATION ABOUT THE PRIOR YEAR:
   (A) DELINEATED BY FORM OF INSURANCE OR PAYOR TYPE, INCLUDING  BUT  NOT
 LIMITED  TO  MEDICAID,  MEDICARE, COMMERCIAL INSURANCE, AND UNINSURED TO
 INCLUDE:
   (I) AGGREGATED ACQUISITION COSTS PAID FOR ALL 340B DRUGS;
   (II) AGGREGATED PAYMENTS RECEIVED FROM INSURERS, PAYORS, AND SELF-PAY-
 ING PATIENTS FOR ALL 340B DRUGS;
   (III) THE TOTAL NUMBER OF PRESCRIPTIONS AND PERCENTAGE OF THE  COVERED
 ENTITY'S PRESCRIPTIONS THAT WERE FILLED WITH 340B DRUGS; AND
   (IV) THE PERCENTAGE OF PATIENTS SERVED BY A SLIDING FEE SCALE FOR 340B
 DRUGS AT THE POINT OF SALE FOR LOW-INCOME PATIENTS.
   (B)  THE  TOTAL  OPERATING COSTS FOR SUCH COVERED ENTITY, AND ITEMIZED
 COSTS FOR:
   (I) IMPLEMENTING DIRECT PASS THROUGH OF 340B PROFITS  TO  PATIENTS  IN
 THE FORM OF LOWER COST SHARING FOR 340B DRUGS AT THE POINT OF DISPENSING
 OR ADMINISTRATION;
   (II)  IMPLEMENTING  A SLIDING FEE SCALE FOR 340B DRUGS AT THE POINT OF
 SALE FOR LOW-INCOME PATIENTS; AND
   (III) CHARITY CARE.
   (C) THE TOTAL PAYMENTS MADE TO:
   (I) CONTRACT PHARMACIES FOR 340B PROGRAM RELATED  SERVICES  AND  OTHER
 FUNCTIONS;
   (II)  THIRD-PARTY  ADMINISTRATORS  FOR MANAGING ANY COMPONENTS OF SUCH
 COVERED ENTITY'S 340B PROGRAM; AND
   (III) ANY OTHER THIRD PARTIES IN CONNECTION WITH 340B  PROGRAM-RELATED
 COMPLIANCE, LEGAL, EDUCATIONAL, AND/OR ADMINISTRATIVE COSTS.
   (D) THE TOTAL NUMBER OF CONTRACT PHARMACIES, INCLUDING:
   (I)  THE  NUMBER  OF  CONTRACT PHARMACIES LOCATED OUT-OF-STATE AND THE
 STATES IN WHICH SUCH OUT-OF-STATE PHARMACIES ARE LOCATED;
   (II) THE TOTAL NUMBER OF  PRESCRIPTIONS  AND  THE  PERCENTAGE  OF  THE
 COVERED  ENTITY'S PRESCRIPTIONS THAT WERE FILLED AT CONTRACT PHARMACIES,
 DELINEATED BY IN-STATE AND OUT-OF-STATE CONTRACT PHARMACIES;
   (III) THE TOTAL REMUNERATION PAID TO OR RETAINED BY  CONTRACT  PHARMA-
 CIES OR THEIR AFFILIATES FOR ANY 340B PROGRAM-RELATED SERVICES PERFORMED
 ON BEHALF OF THE COVERED ENTITY; AND
   (IV)  THE  PERCENTAGE CHANGE IN TOTAL REMUNERATION PAID TO OR RETAINED
 BY CONTRACT PHARMACIES OR THEIR AFFILIATES AS DESCRIBED IN  SUBPARAGRAPH
 (III) OF THIS PARAGRAPH COMPARED TO THE PRIOR YEAR.
   3.  AN  OFFICER OF A COVERED ENTITY SHALL CERTIFY THE COMPLETENESS AND
 ACCURACY OF THE REPORT SUBMITTED PURSUANT TO  SUBDIVISION  TWO  OF  THIS
 SECTION.
   4. THE DEPARTMENT SHALL POST ALL REPORTS SUBMITTED BY COVERED ENTITIES
 PURSUANT  TO  SUBDIVISION  TWO  OF THIS SECTION ON A PUBLICLY ACCESSIBLE
 WEBSITE.
   § 2. This act shall take effect immediately.