NY State Senate Bill 2023-S7413

Senate Bill S7413

2023-2024 Legislative Session

Establishes patient safety and quality assurance measures regarding the distribution of patient-specific medication from an insurer-designated pharmacy

download bill text pdf

Current Bill Status - In Senate Committee Insurance Committee

Introduced
- In Committee Assembly
- In Committee Senate
- On Floor Calendar Assembly
- On Floor Calendar Senate
- Passed Assembly
- Passed Senate
Delivered to Governor
Signed By Governor

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	Assembly Actions - Lowercase Senate Actions - UPPERCASE
Jan 03, 2024	referred to insurance
May 23, 2023	referred to insurance

2023-S7413 (ACTIVE) - Details

See Assembly Version of this Bill:: A2163
Current Committee:: Senate Insurance
Law Section:: Insurance Law
Laws Affected:: Amd §§3217-b & 4325, Ins L; amd §4406-c, Pub Health L
Versions Introduced in 2021-2022 Legislative Session:: S7252, A9516

2023-S7413 (ACTIVE) - Summary

Establishes patient safety and quality assurance measures regarding the distribution of patient-specific medication from an insurer-designated pharmacy; prohibits certain "brown bagging" and "white bagging" policies regarding pharmacy provided medications.

2023-S7413 (ACTIVE) - Sponsor Memo

                                 
BILL NUMBER: S7413

SPONSOR: BRESLIN
 
TITLE OF BILL:

An act to amend the insurance law and the public health law, in relation
to establishing patient safety and quality assurance measures regarding
the distribution of patient-specific medication from an insurer-desig-
nated pharmacy

 
PURPOSE OR GENERAL IDEA OF BILL:

The purpose of this legislation is to improve patient safety and quality
assurance associated with health plan policies requiring the use of a
designated pharmacy to dispense a specialty drug intended for adminis-
tration by a clinician. These policies are commonly referred to as
"white bagging" and "brown bagging."

 
SUMMARY OF SPECIFIC PROVISIONS:

This bill would amend §§ 3217-b and 4325 of the insurance law and 4406-c
of the public health law to ensure quality assurance and patient safety

regarding policies known as white and brown bagging of specialty drugs.

The bill would:Prohibit a health insurer from requiring the use of an
insurer-designated pharmacy to dispense a drug directly to a patient
with the intention that the patient will transport the medication to a
physician's office, hospital or clinic for administration. This is type
of policy is also known "brown bagging."

Authorize an insurer to offer coverage for, but not require, the use of
a home infusion pharmacy. to dispense intravenous drugs that have been
ordered by a physician for administration to a patient at a site other
than the patient's provider site.

Prohibit an insurer from requiring the distribution of patient-specific
medication from an insurer-designated pharmacy to a physician's office,
hospital or clinic (known as "white bagging") unless the insurer has an
agreement with the provider that is responsible for receiving and admin-
istering the medication that includes specified notice, quality assur-
ance and patient safety provisions.

Prohibit "white bagging" policies for medications requiring sterile
compounding by a provider or medications with a patient-specific dosage
requirement that is based on lab or test results on the day of the
patient's visit.

 
JUSTIFICATION:

Increasingly, health insurance plans have begun implementing policies
that prohibit a healthcare provider from procuring and managing the
handling of a drug used in patient care. Instead the insurer requires
the use of an insurer-designated, third-party specialty pharmacy to
dispense a specialty drug for administration by a clinician. These poli-
cies are commonly referred to as "white bagging" and "brown bagging."

"Brown bagging" policies require a specialty drug to be dispensed by an
insurer-designated pharmacy directly to a Patient, who then delivers the
drug to a clinician for administration. This policy presents numerous
chain of custody and patient safety concerns, which were recognized as
problematic and as such, prohibited by the NYS Medicaid program in its
August 2019 eMed guidance. The guidance states that this practice "caus-
es concern regarding proper storage or handling, which can affect the
drug efficacy. Brown bagging is not acceptable under NYS Medicaid." This
bill would extend and apply this prohibition to all state-regulated
insurance plans and policies.

"White bagging" policies also require the use of a third-party,
insured-directed pharmacy to dispense a specialty drug. However, in this
case, the drug is delivered directly to a hospital pharmacy or physi-
cian's office, which then stores the drug until a clinician administers
the drug to the patient. Since the provider no longer controls or owns
the specialty drug, they cannot verify the source of the medications.
Also since they are not responsible for coordinating the delivery and
receipt of the drug they are unable to ensure that the drug was stored
at the proper temperature prior to arrival at the hospital or clinic, or
that the hospital or clinic is ready and able to receive and store
products. Unexpected or surprise deliveries create significant, avoid-
able challenges related to supply chain and storage capacity that could
result in a violation of the individual hospital supply acquisition
guidelines.

The NYS Medicaid program also recognizes this "white bagging" policy and
deems it acceptable only under specific guidelines addressing concerns
related to responsibility and timeliness of delivery of these drugs to
the administering clinician. This bill would extend and expand these
guidelines to all state-regulated insurance plans and policies to ensure
that comprehensive patient protections and quality assurance measures
are in place for all insureds, regardless of their health insurance
plan.

The bill would also include additional "white bagging" protections to
address patient care implications related to certain drug therapy treat-
ments, such as oncology. The bill would prohibit "white bagging" for
drugs that require a provider to make real-time medication adjustments
based on necessary, same day lab and test results. This important
patient-protection would prevent unnecessary delays in treatment, which
could increase patient risk and adversely affect the patient's treat-
ment.

 
PRIOR LEGISLATIVE HISTORY:

S7252 - 2022

 
FISCAL IMPLICATIONS:

None to the state.

 
EFFECTIVE DATE:
This act shall take effect immediately.

2023-S7413 (ACTIVE) - Bill Text download pdf

                             
                     S T A T E   O F   N E W   Y O R K
 ________________________________________________________________________
 
                                   7413
 
                        2023-2024 Regular Sessions
 
                             I N  S E N A T E
 
                               May 23, 2023
                                ___________
 
 Introduced  by  Sen. BRESLIN -- read twice and ordered printed, and when
   printed to be committed 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
 S. 7413                             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;
 S. 7413                             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;
 S. 7413                             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.

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