NY State Senate Bill 2023-S6332

Senate Bill S6332

2023-2024 Legislative Session

Limits the substitution of abuse-deterrent analgesic opioid drug products for analgesic opioids lacking such technology

download bill text pdf

Current Bill Status - In Senate Committee Health 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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Actions

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	Assembly Actions - Lowercase Senate Actions - UPPERCASE
Jan 03, 2024	referred to health
Apr 14, 2023	referred to health

2023-S6332 (ACTIVE) - Details

See Assembly Version of this Bill:: A62
Current Committee:: Senate Health
Law Section:: Public Health Law
Laws Affected:: Amd §273, Pub Health L; add §3216-a, Ins L
Versions Introduced in Other Legislative Sessions:: 2019-2020: S6397
2021-2022: S4532, A4667

2023-S6332 (ACTIVE) - Summary

Provides for patient access to FDA approved abuse-deterrent technology to help combat opioid abuse.

2023-S6332 (ACTIVE) - Sponsor Memo

                                 
BILL NUMBER: S6332

SPONSOR: BROUK
 
TITLE OF BILL:

An act to amend the public health law and the insurance law, in relation
to the use of abuse-deterrent technology for opioids as a mechanism for
reducing abuse and diversion of opioid drugs

 
PURPOSE:

To help prevent the abuse and diversion of opioid analgesic drugs by
ensuring that abuse-deterrent drugs approved by the FDA are accessible
to patients and that that insurance coverage does not disadvantage.
access for patients to drugs approved by the FDA as abuse-deterrent.

 
SUMMARY OF PROVISIONS:

Section 1 adds a new subdivision 11 to section 273 of the public health
law to ensure patient access to abuse-deterrent opioid analgesic drugs
by requiring that a minimum of one opioid abuse-deterrent opioid anal-
gesic drug per opioid analgesic active ingredient is covered by insur-

ance plans and to ensure that a patient is not required to take a non-a-
buse deterrent opioid before an abuse-deterrent opioid version.

Section 2 adds a new section 3216-a to the insurance law to ensure
patient access to abuse-deterrent opioid analgesic drugs by requiring
that a minimum of one opioid abuse-deterrent opioid analgesic drug per
opioid analgesic active ingredient is covered by insurance plans and to
ensure that a patient is not required to take a non-abuse deterrent
opioid before an abuse-deterrent opioid version.

Section 3 sets the effective date.

 
JUSTIFICATION:

Abuse deterrent formulations (ADFs) represent a breakthrough technology
that helps prevent the crushing, snorting, and injection of painkillers.
Currently, many prescription drug plans present access barriers for
chronic pain patients to ADFs including cost-sharing tiers, fail-first
requirements, and prior authorization requirements. Instead of receiving
ADFs, often patients are limited to using traditional opioids that can
be easily diverted, crushed, snorted, and injected. The U.S. Food and
Drug Administration (FDA)is encouraging the development of prescription
opioids with abuse-deterrent formulations to help combat the opioid
crisis. The agency recognizes that abuse-deterrent opioids are not
abuse- or addiction-proof but are a step toward products that may help
reduce abuse. According to the FDA, "abuse-deterrent formulations target
the known or expected routes of abuse, such as crushing in order to
snort or dissolving in order to inject, for the specific opioid drug
substance. The science of abuse deterrence is relatively new, and both
the formulation technologies and the analytical, clinical, and statis-
tical methods for evaluating those technologies are rapidly evolving."

 
LEGISLATIVE HISTORY:

2021-22: S4532 - Passed Senate;A4667 - Referred to Insurance.

 
FISCAL IMPLICATIONS:
None.

 
EFFECTIVE DATE:
This act shall take effect on the 120th day after it shall have become a
law, and shall apply to all policies and contracts issues, renewed,
modified, altered or amended on or after such date.

2023-S6332 (ACTIVE) - Bill Text download pdf

                             
                     S T A T E   O F   N E W   Y O R K
 ________________________________________________________________________
 
                                   6332
 
                        2023-2024 Regular Sessions
 
                             I N  S E N A T E
 
                              April 14, 2023
                                ___________
 
 Introduced  by  Sen.  BROUK  -- read twice and ordered printed, and when
   printed to be committed to the Committee on Health
 
 AN ACT to amend the public health law and the insurance law, in relation
   to the use of abuse-deterrent technology for opioids  as  a  mechanism
   for reducing abuse and diversion of opioid drugs

   THE  PEOPLE OF THE STATE OF NEW YORK, REPRESENTED IN SENATE AND ASSEM-
 BLY, DO ENACT AS FOLLOWS:
 
   Section 1. Section 273 of the public health law is amended by adding a
 new subdivision 11 to read as follows:
   11. ANY PRIOR AUTHORIZATION REQUIREMENTS FOR OPIOID ANALGESIC AND  ANY
 SERVICE  DENIALS  MADE  PURSUANT THERETO SHALL NOT REQUIRE USE OF OPIOID
 ANALGESIC  DRUG  PRODUCTS  WITHOUT  ABUSE-DETERRENT  PROPERTIES   BEFORE
 AUTHORIZING THE USE OF ABUSE-DETERRENT OPIOID ANALGESIC DRUG PRODUCTS.
   §  2.  The  insurance law is amended by adding a new section 3216-a to
 read as follows:
   § 3216-A.  ACCESS TO ABUSE-DETERRENT OPIOID MEDICATIONS. (A) AN INSUR-
 ANCE CARRIER OR HEALTH PLAN SHALL PROVIDE  COVERAGE  ON  ITS  FORMULARY,
 DRUG  LIST  OR  OTHER LISTS OF SIMILAR CONSTRUCT FOR AT LEAST ONE ABUSE-
 DETERRENT OPIOID ANALGESICS DRUG PRODUCT PER  OPIOID  ANALGESICS  ACTIVE
 INGREDIENT.
   (1)  COST-SHARING FOR BRAND NAME ABUSE-DETERRENT OPIOID ANALGESIC DRUG
 PRODUCTS COVERED PURSUANT TO THIS SECTION SHALL NOT  EXCEED  THE  LOWEST
 COST-SHARING  LEVEL  APPLIED  TO  BRAND  NAME NON-ABUSE DETERRENT OPIOID
 DRUGS COVERED UNDER THE APPLICABLE HEALTH PLAN OR POLICY.
   (2) COST-SHARING FOR GENERIC  ABUSE-DETERRENT  OPIOID  ANALGESIC  DRUG
 PRODUCTS  COVERED  PURSUANT  TO THIS SECTION SHALL NOT EXCEED THE LOWEST
 COST-SHARING LEVEL APPLIED TO GENERIC NON-ABUSE DETERRENT  OPIOID  DRUGS
 COVERED UNDER THE APPLICABLE HEALTH PLAN OR POLICY.
   (3)  AN INCREASE IN PATIENT COST-SHARING OR DISINCENTIVES FOR PRESCRI-
 BERS OR DISPENSERS SHALL NOT BE ALLOWED TO ACHIEVE COMPLIANCE WITH  THIS
 SECTION.
 
  EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets
                       [ ] is old law to be omitted.
                                                            LBD01769-01-3

 S. 6332                             2
 
   (B)  ANY  PRIOR-AUTHORIZATION REQUIREMENTS OR OTHER UTILIZATION REVIEW
 MEASURES FOR OPIOID ANALGESICS, AND ANY SERVICE  DENIALS  MADE  PURSUANT
 THERETO, SHALL NOT REQUIRE USE OF OPIOID ANALGESIC DRUG PRODUCTS WITHOUT
 ABUSE-DETERRENT  PROPERTIES  IN  ORDER  TO ACCESS ABUSE-DETERRENT OPIOID
 ANALGESIC DRUG PRODUCTS.
   (C) DEFINITIONS. AS USED IN THIS SECTION:
   (1)  "OPIOID  ANALGESIC DRUG PRODUCT" MEANS A DRUG IN THE OPIOID ANAL-
 GESIC DRUG CLASS PRESCRIBED TO TREAT MODERATE TO SEVERE  PAIN  OR  OTHER
 CONDITIONS, WHETHER IN IMMEDIATE RELEASE OR EXTENDED LONG ACTING RELEASE
 FORM  AND  WHETHER  OR NOT COMBINED WITH OTHER DRUG SUBSTANCES TO FORM A
 SINGLE DRUG PRODUCT OR OTHER DOSAGE FORM.
   (2) "ABUSE DETERRENT OPIOID ANALGESIC DRUG PRODUCT" MEANS A  BRAND  OR
 GENERIC  OPIOID  ANALGESIC DRUG PRODUCT APPROVED BY THE FEDERAL FOOD AND
 DRUG ADMINISTRATION WITH ABUSE-DETERRENCE LABELING CLAIMS INDICATING ITS
 ABUSE-DETERRENT PROPERTIES ARE EXPECTED TO DETER OR REDUCE ITS ABUSE.
   (3) "COST-SHARING" MEANS ANY COVERAGE LIMIT,  COPAYMENT,  COINSURANCE,
 DEDUCTIBLE OR OTHER OUT-OF-POCKET PATIENT EXPENSE REQUIREMENTS.
   § 3. This act shall take effect on the one hundred twentieth day after
 it  shall  have  become  a  law,  and  shall  apply  to all policies and
 contracts issued, renewed, modified, altered or amended on or after such
 date.

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