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

9 Co-sponsors

• George Amedore
• Terrence P. Murphy
• Robert Ortt
• Phil Boyle
• Thomas Croci
• Martin J. Golden
• Ruth Hassell-Thompson
• William J. Larkin Jr.
• Jack M. Martins

BILL NUMBER:S5170A

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 dispensed whenever prescribed and not substituted by non-abuse deterrent opioids and that that insurance coverage does not disadvantage drugs approved by the FDA as abuse-deterrent.

Summary of provisions

Section 1 adds a new section 3340 to the Public health law to ensure that an opioid analgesic drug product, brand or generic, with abuse-deterrent technologies is not interchanged or substituted with an opioid analgesic drug product lacking abuse-deterrent technologies without obtaining a new prescription from the provider.

Section 2 adds a new section to the insurance law to: ensure that abuse-deterrent opioid products are covered by insurance plans at least the same levels as non-abuse-deterrent opioid products and ensure that a patient is not required to take a non-abuse-deterrent opioid before an abuse-deterrent version.

Section 3 is the effective date of the bill.

Justification

While pain management is an important and integral part of the health care system, abuse and diversion of opioids has necessitated the implementation of various anti-abuse policies. These policies need to be approached comprehensively by government, law enforcement, health care providers and manufacturers and an important component is to ensure that opioids incorporating abuse-deterrent technologies are dispensed whenever possible.

The U.S. Food and Drug Administration (FDA) has recognized that the development and implementation of abuse-deterrent technologies is an important "step towards the goal of creating safer opioid analgesics." In recently published FDA guidance on abuse-deterrent technologies for opioids, the FDA provided that they "considers the development of these products a high public health priority."

Under this proposal, when a physician prescribes an opioid analgesic drug that incorporates abuse-deterrent technologies, no substitution or interchange shall be permitted for that drug without a new prescription from their doctor or health care provider.

This proposal also recognizes that to further the goal of encouraging the use of abuse-deterrent technologies as part of a broader plan to reduce opioid addiction and abuse, it is imperative that insurance coverage is applied equitably and does not provide a disincentive to the use of abuse-deterrent opioids.

While New York State has been at the forefront of fighting prescription drug abuse, it is critical that the State continue to

strengthen its laws and protect against abuse while enhancing the integrity of its health care system. Enacting this proposal will be consistent with these goals and with the priorities set out by the FDA.

Legislative history

New bill.

Fiscal implications

None.

Effective date

This act shall take effect on the 120th day, and shall apply to all policies and contracts issued, renewed, modified, altered or amended on or after such date.