S T A T E   O F   N E W   Y O R K
 ________________________________________________________________________
 
                                   2163
 
                        2023-2024 Regular Sessions
 
                           I N  A S S E M B L Y
 
                             January 23, 2023
                                ___________
 
 Introduced  by  M.  of  A. L. ROSENTHAL -- read once and referred to the
   Committee on Insurance
 
 AN ACT to amend the insurance law and the public health law, in relation
   to establishing patient safety and quality assurance measures  regard-
   ing  the  distribution of patient-specific medication from an insurer-
   designated pharmacy

   THE PEOPLE OF THE STATE OF NEW YORK, REPRESENTED IN SENATE AND  ASSEM-
 BLY, DO ENACT AS FOLLOWS:
 
   Section  1. Section 3217-b of the insurance law is amended by adding a
 new subsection (p) to read as follows:
   (P) (1) NO INSURER SUBJECT TO THIS ARTICLE SHALL BY CONTRACT,  WRITTEN
 POLICY OR WRITTEN PROCEDURE ALLOW OR REQUIRE AN INSURER-DESIGNATED PHAR-
 MACY  TO  DISPENSE A MEDICATION DIRECTLY TO A PATIENT WITH THE INTENTION
 THAT SUCH PATIENT  WILL  TRANSPORT  SUCH  MEDICATION  TO  A  PHYSICIAN'S
 OFFICE, HOSPITAL OR CLINIC FOR ADMINISTRATION.
   (2)  AN  INSURER  SUBJECT  TO THIS ARTICLE MAY OFFER COVERAGE FOR, BUT
 SHALL NOT REQUIRE THE USE OF A HOME INFUSION PHARMACY TO DISPENSE  STER-
 ILE  INTRAVENOUS  DRUGS ORDERED BY PHYSICIANS TO PATIENTS IN THEIR HOMES
 OR THE USE OF AN INFUSION SITE EXTERNAL TO A PATIENT'S  PROVIDER  OFFICE
 OR CLINIC.
   (3)  AN  INSURER  SUBJECT  TO  THIS  ARTICLE,  IN ORDER TO REQUIRE THE
 DISTRIBUTION OF PATIENT-SPECIFIC MEDICATION FROM  AN  INSURER-DESIGNATED
 PHARMACY TO A PHYSICIAN'S OFFICE, HOSPITAL OR CLINIC FOR ADMINISTRATION,
 SHALL  ESTABLISH  AN  AGREEMENT  WITH  THE PHYSICIAN, HOSPITAL OR CLINIC
 RESPONSIBLE FOR RECEIVING AND ADMINISTERING SUCH MEDICATIONS  TO  ENSURE
 PROPER  RECEIPT, TRANSFER, HANDLING, AND STORAGE OF THE MEDICATION PRIOR
 TO ADMINISTRATION THAT INCLUDES, BUT IS NOT LIMITED  TO,  THE  FOLLOWING
 PROVISIONS:
   (A)  PROVIDE  AT  LEAST  NINETY DAYS' NOTICE TO PROVIDERS AND INSURERS
 PRIOR TO THE IMPLEMENTATION OF SUCH A REQUIREMENT;
 
  EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets
                       [ ] is old law to be omitted.
                                                            LBD05796-01-3
 A. 2163                             2
              

 
   (B) HAVE A PATIENT-SPECIFIC EXPEDITED EXCEPTION PROCESS FOR  CASES  IN
 WHICH  A  PROVIDER  CERTIFIES THAT IT IS UNSAFE FOR A PATIENT TO RECEIVE
 MEDICATION FROM AN INSURER-DESIGNATED PHARMACY;
   (C) PROVIDE SAME DAY DELIVERY OF MEDICATIONS;
   (D) MAKE AVAILABLE ON-CALL ACCESS TO A PHARMACIST OR NURSE TWENTY-FOUR
 HOURS PER DAY, SEVEN DAYS PER WEEK;
   (E)  UTILIZE  COLD  CHAIN  LOGISTICS  OR  OTHER MEANS TO ENSURE A DRUG
 REMAINS AT THE APPROPRIATE TEMPERATURE THROUGH ALL STAGES OF SUPPLY  AND
 STORAGE;
   (F)  PROVIDE  A  MEDICATION'S  PEDIGREE  TO CERTIFY TO THE PHYSICIAN'S
 OFFICE, HOSPITAL OR CLINIC  THAT  THE  DRUG  WAS  HANDLED  APPROPRIATELY
 THROUGH THE SUPPLY CHAIN;
   (G) DEMONSTRATE EXPERTISE AND RELIABILITY IN RISK EVALUATION AND MITI-
 GATION  STRATEGY  TO  COMPLY  WITH  UNITED STATES FOOD AND DRUG ADMINIS-
 TRATION REPORTING REQUIREMENTS;
   (H) DEMONSTRATE THE INSURER-DESIGNATED PHARMACY  IS  ACCREDITED  BY  A
 NATIONAL ACCREDITATION ORGANIZATION;
   (I)  DEMONSTRATE  ABILITY  TO  DELIVER  MEDICATIONS  TO  A PHYSICIAN'S
 OFFICE, HOSPITAL OR CLINIC IN A CLINICALLY APPROPRIATE DOSAGE AND  IN  A
 READY-TO-ADMINISTER DOSAGE FORM; AND
   (J) OFFER SITE NEUTRAL PAYMENT FOR SUCH MEDICATIONS TO THE PHYSICIAN'S
 OFFICE,  HOSPITAL  OR CLINIC ADMINISTERING THE MEDICATION, WHICH PAYMENT
 SHALL INCLUDE THE COSTS FOR THE PROVIDERS TO INTAKE, STORE  AND  DISPOSE
 OF SUCH MEDICATIONS.
   (4)  NO  INSURER  SUBJECT  TO  THIS ARTICLE SHALL BY CONTRACT, WRITTEN
 POLICY OR WRITTEN PROCEDURE REQUIRE (A) A MEDICATION  REQUIRING  STERILE
 COMPOUNDING BY THE PROVIDER, OR (B) A MEDICATION WITH A PATIENT-SPECIFIC
 DOSAGE  REQUIREMENT  TO  BE BASED UPON LAB OR TEST RESULTS ON THE DAY OF
 THE PATIENT VISIT, TO BE DISTRIBUTED FROM AN INSURER-DESIGNATED PHARMACY
 TO A PHYSICIAN'S OFFICE, HOSPITAL OR CLINIC FOR ADMINISTRATION.
   § 2. Section 4325 of the insurance law is  amended  by  adding  a  new
 subsection (p) to read as follows:
   (P) (1) NO CORPORATION ORGANIZED UNDER THIS ARTICLE SHALL BY CONTRACT,
 WRITTEN  POLICY  OR WRITTEN PROCEDURE ALLOW OR REQUIRE AN INSURER-DESIG-
 NATED PHARMACY TO DISPENSE A MEDICATION DIRECTLY TO A PATIENT  WITH  THE
 INTENTION  THAT  THE  PATIENT  WILL TRANSPORT THE MEDICATION TO A PHYSI-
 CIAN'S OFFICE, HOSPITAL OR CLINIC FOR ADMINISTRATION.
   (2) A CORPORATION ORGANIZED UNDER THIS ARTICLE MAY OFFER COVERAGE FOR,
 BUT SHALL NOT REQUIRE THE USE OF A HOME INFUSION  PHARMACY  TO  DISPENSE
 STERILE  INTRAVENOUS  DRUGS  ORDERED  BY PHYSICIANS TO PATIENTS IN THEIR
 HOMES OR THE USE OF AN INFUSION SITE EXTERNAL TO  A  PATIENT'S  PROVIDER
 OFFICE OR CLINIC.
   (3)  A  CORPORATION  ORGANIZED UNDER THIS ARTICLE, IN ORDER TO REQUIRE
 THE DISTRIBUTION OF PATIENT-SPECIFIC MEDICATION FROM  AN  INSURER-DESIG-
 NATED  PHARMACY TO A PHYSICIAN'S OFFICE, HOSPITAL OR CLINIC FOR ADMINIS-
 TRATION, SHALL ESTABLISH AN AGREEMENT WITH THE  PHYSICIAN,  HOSPITAL  OR
 CLINIC  RESPONSIBLE  FOR RECEIVING AND ADMINISTERING SUCH MEDICATIONS TO
 ENSURE PROPER RECEIPT, TRANSFER, HANDLING, AND STORAGE OF THE MEDICATION
 PRIOR TO ADMINISTRATION THAT  INCLUDES,  BUT  IS  NOT  LIMITED  TO,  THE
 FOLLOWING PROVISIONS:
   (A)  PROVIDE  AT  LEAST  NINETY DAYS' NOTICE TO PROVIDERS AND INSUREDS
 PRIOR TO THE IMPLEMENTATION OF SUCH A REQUIREMENT;
   (B) HAVE A PATIENT-SPECIFIC EXPEDITED EXCEPTION PROCESS FOR  CASES  IN
 WHICH  A  PROVIDER  CERTIFIES THAT IT IS UNSAFE FOR A PATIENT TO RECEIVE
 MEDICATION FROM AN INSURER-DESIGNATED PHARMACY;
   (C) PROVIDE SAME DAY DELIVERY OF MEDICATIONS;
 A. 2163                             3
 
   (D) MAKE AVAILABLE ON-CALL ACCESS TO A PHARMACIST OR NURSE TWENTY-FOUR
 HOURS PER DAY, SEVEN DAYS PER WEEK;
   (E)  UTILIZE  COLD  CHAIN  LOGISTICS  OR  OTHER MEANS TO ENSURE A DRUG
 REMAINS AT THE APPROPRIATE TEMPERATURE THROUGH ALL STAGES OF SUPPLY  AND
 STORAGE;
   (F)  PROVIDE  A  MEDICATION'S  PEDIGREE  TO CERTIFY TO THE PHYSICIAN'S
 OFFICE, HOSPITAL OR CLINIC  THAT  THE  DRUG  WAS  HANDLED  APPROPRIATELY
 THROUGH THE SUPPLY CHAIN;
   (G) DEMONSTRATE EXPERTISE AND RELIABILITY IN RISK EVALUATION AND MITI-
 GATION  STRATEGY  TO  COMPLY  WITH  UNITED STATES FOOD AND DRUG ADMINIS-
 TRATION REPORTING REQUIREMENTS;
   (H) DEMONSTRATE THE INSURER-DESIGNATED PHARMACY  IS  ACCREDITED  BY  A
 NATIONAL ACCREDITATION ORGANIZATION;
   (I)  DEMONSTRATE  ABILITY  TO  DELIVER  MEDICATIONS  TO  A PHYSICIAN'S
 OFFICE, HOSPITAL OR CLINIC IN A CLINICALLY APPROPRIATE DOSAGE AND  IN  A
 READY-TO-ADMINISTER DOSAGE FORM; AND
   (J) OFFER SITE NEUTRAL PAYMENT FOR SUCH MEDICATIONS TO THE PHYSICIAN'S
 OFFICE,  HOSPITAL  OR CLINIC ADMINISTERING THE MEDICATION, WHICH PAYMENT
 SHALL INCLUDE THE COSTS FOR THE PROVIDERS TO INTAKE, STORE  AND  DISPOSE
 OF SUCH MEDICATIONS.
   (4)  NO  CORPORATION  ORGANIZED  UNDER THIS ARTICLE SHALL BY CONTRACT,
 WRITTEN POLICY OR WRITTEN PROCEDURE REQUIRE (A) A  MEDICATION  REQUIRING
 STERILE  COMPOUNDING  BY  THE  PROVIDER,  OR  (B)  A  MEDICATION  WITH A
 PATIENT-SPECIFIC DOSAGE REQUIREMENT TO BE BASED UPON LAB OR TEST RESULTS
 ON THE DAY OF THE PATIENT VISIT, TO BE DISTRIBUTED FROM  AN  INSURER-DE-
 SIGNATED PHARMACY TO A PHYSICIAN'S OFFICE, HOSPITAL OR CLINIC FOR ADMIN-
 ISTRATION.
   §  3.  Section  4406-c of the public health law is amended by adding a
 new subdivision 13 to read as follows:
   13. (A) NO HEALTH CARE PLAN SHALL BY CONTRACT  OR  WRITTEN  POLICY  OR
 WRITTEN  PROCEDURE  ALLOW  OR  REQUIRE  A  PLAN-DESIGNATED  PHARMACY  TO
 DISPENSE A MEDICATION DIRECTLY TO A PATIENT WITH THE INTENTION THAT  THE
 PATIENT  WILL TRANSPORT THE MEDICATION TO A PHYSICIAN'S OFFICE, HOSPITAL
 OR CLINIC FOR ADMINISTRATION.
   (B) A HEALTH CARE PLAN MAY OFFER COVERAGE FOR, BUT SHALL  NOT  REQUIRE
 THE  USE  OF  A  HOME  INFUSION PHARMACY TO DISPENSE STERILE INTRAVENOUS
 DRUGS ORDERED BY PHYSICIANS TO PATIENTS IN THEIR HOMES OR THE USE OF  AN
 INFUSION SITE EXTERNAL TO A PATIENT'S PROVIDER OFFICE OR CLINIC.
   (C)  A  HEALTH  CARE  PLAN,  IN  ORDER  TO REQUIRE THE DISTRIBUTION OF
 PATIENT-SPECIFIC MEDICATION FROM AN  INSURER-DESIGNATED  PHARMACY  TO  A
 PHYSICIAN'S  OFFICE, HOSPITAL OR CLINIC FOR ADMINISTRATION, SHALL ESTAB-
 LISH AN AGREEMENT WITH THE PHYSICIAN, HOSPITAL OR CLINIC RESPONSIBLE FOR
 RECEIVING AND ADMINISTERING SUCH MEDICATIONS TO ENSURE  PROPER  RECEIPT,
 TRANSFER,  HANDLING,  AND  STORAGE  OF  THE MEDICATION PRIOR TO ADMINIS-
 TRATION THAT INCLUDES, BUT IS NOT LIMITED TO, THE FOLLOWING PROVISIONS:
   (I) PROVIDE AT LEAST NINETY DAYS' NOTICE TO  PROVIDERS  AND  ENROLLEES
 PRIOR TO THE IMPLEMENTATION OF SUCH A REQUIREMENT;
   (II)  HAVE A PATIENT-SPECIFIC EXPEDITED EXCEPTION PROCESS FOR CASES IN
 WHICH A PROVIDER CERTIFIES THAT IT IS UNSAFE FOR A  PATIENT  TO  RECEIVE
 MEDICATION FROM A PLAN-DESIGNATED PHARMACY;
   (III) PROVIDE SAME DAY DELIVERY OF MEDICATIONS;
   (IV)  MAKE  AVAILABLE  ON-CALL ACCESS TO A PHARMACIST OR NURSE TWENTY-
 FOUR HOURS PER DAY, SEVEN DAYS PER WEEK;
   (V) UTILIZE COLD CHAIN LOGISTICS OR  OTHER  MEANS  TO  ENSURE  A  DRUG
 REMAINS  AT THE APPROPRIATE TEMPERATURE THROUGH ALL STAGES OF SUPPLY AND
 STORAGE;
 A. 2163                             4
 
   (VI) PROVIDE A MEDICATION'S PEDIGREE TO  CERTIFY  TO  THE  PHYSICIAN'S
 OFFICE,  HOSPITAL  OR  CLINIC  THAT  THE  DRUG WAS HANDLED APPROPRIATELY
 THROUGH THE SUPPLY CHAIN;
   (VII)  DEMONSTRATE  EXPERTISE  AND  RELIABILITY IN RISK EVALUATION AND
 MITIGATION STRATEGY TO COMPLY WITH UNITED STATES FOOD AND DRUG  ADMINIS-
 TRATION REPORTING REQUIREMENTS;
   (VIII)  DEMONSTRATE THE INSURER-DESIGNATED PHARMACY IS ACCREDITED BY A
 NATIONAL ACCREDITATION ORGANIZATION;
   (IX) DEMONSTRATE ABILITY  TO  DELIVER  MEDICATIONS  TO  A  PHYSICIAN'S
 OFFICE,  HOSPITAL  OR CLINIC IN A CLINICALLY APPROPRIATE DOSAGE AND IN A
 READY-TO-ADMINISTER DOSAGE FORM; AND
   (X) OFFER SITE NEUTRAL PAYMENT FOR SUCH MEDICATIONS TO THE PHYSICIAN'S
 OFFICE, HOSPITAL OR CLINIC ADMINISTERING THE MEDICATION,  WHICH  PAYMENT
 SHALL  INCLUDE  THE COSTS FOR THE PROVIDERS TO INTAKE, STORE AND DISPOSE
 OF SUCH MEDICATIONS.
   (D) NO HEALTH CARE PLAN SHALL BY CONTRACT, WRITTEN POLICY  OR  WRITTEN
 PROCEDURE  REQUIRE  (I)  A MEDICATION REQUIRING STERILE COMPOUNDING BY A
 PROVIDER, OR (II) A MEDICATION WITH A PATIENT-SPECIFIC  DOSAGE  REQUIRE-
 MENT  TO  BE  BASED  UPON  LAB OR TEST RESULTS ON THE DAY OF THE PATIENT
 VISIT, TO BE DISTRIBUTED FROM A PLAN-DESIGNATED  PHARMACY  TO  A  PHYSI-
 CIAN'S OFFICE, HOSPITAL OR CLINIC FOR ADMINISTRATION.
   § 4. This act shall take effect immediately.