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S7009Senate2017-2018 SessionSame asA7999

Limit Opioid Substitutions

Official title

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

Sponsor Andrew J. LanzaSD-24Affects Finance
Status
In Senate Committee
Insurance
Impact
7/10
Significant
Passage
0%

Bill progress

Step 2 of 7

In committee · Insurance

What's happening

This bill requires insurance plans in New York to cover at least one abuse-deterrent opioid medication per active ingredient, with limits on patient cost-sharing.

Why it matters

  1. Could make abuse-deterrent opioids more accessible and affordable. by ensuring insurance plans can't put them in higher cost-sharing tiers than standard opioids, potentially encouraging safer prescribing and use.

  2. Limits insurance companies' ability to use prior authorization or step therapy to block access. to abuse-deterrent formulations, removing a common barrier for patients who need these medications.

  3. May help reduce opioid misuse and diversion. by increasing patient access to medications that are designed to be harder to abuse, addressing a root cause of the opioid crisis.

  4. Shifts some prescribing incentives. By prohibiting insurers from increasing costs for patients, prescribers, or pharmacists to comply, it could remove financial disincentives to choose abuse-deterrent drugs over traditional opioids.

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Who cares

Headline styles

Limit Opioid Substitutions

Plain English, a few words. Used as the page title.

Sponsors

Primary sponsor
Andrew J. Lanza

Senator · Senate District 24

Chair, Codes

No co-sponsors yet.

History

  1. Referred to insurance

Companion bill

The same bill in the other chamber. A bill becomes law when one version passes both houses and the governor signs it, so either number can carry it.

A7999Assembly

Protect Access to Safer Opioids

In Assembly Committee · Insurance · Sponsor Michael Cusick

Impact 7 · Significant0% to pass

Full text

2 pagesUnderlined is new[Struck] is removedOfficial text on nysenate.gov ↗

STATE OF NEW YORK

7009

IN SENATE (Prefiled)

January 3, 2018

Introduced by Sen. LANZA -- read twice and ordered printed, and when printed to be committed to the Committee on Insurance

AN ACT to amend 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 Assembly, do enact as follows:

Section 1. 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 insurance carrier or health plan shall provide coverage on its formulary, drug list or other lists of similar construct for at least one abusedeterrent opioid analgesic drug product per opioid analgesic 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 prescribers or dispensers shall not be allowed to achieve compliance with this section.

(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 analgesic drug class prescribed to treat moderate to severe pain or other

EXPLANATION--Matter in italics (underscored) is new; matter in brackets

[ ] is old law to be omitted.

LBD11878-01-7

S. 7009 2

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.

§ 2. 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.

Reflowed for reading: line numbers and page breaks removed. Cite the official text.

Sponsor's memo

Title of bill

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

Purpose or general idea of bill

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 specific provisions

Section 1 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 2 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 imple- mentation 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 whenev- er 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 "consider the development of these products a high public health-priority."

To combat opioid misuse and abuse, the FDA is encouraging manufacturers to develop abuse-deterrent formulations that when taken as prescribed still provide appropriate pain relief, but are-formulated to make it more difficult to alter the drug product for purposes of misuse or abuse, such as making the product harder to crush or liquefy in order to snort or inject. The FDA has provided guidance as to the steps that a manufacturer can take to demonstrate that an opioid drug product is formulated with abuse-deterrent technologies and after rigorous testing has shown that the abuse-deterrent formulation is expected to deter or reduce abuse of the drug product. It is only after achieving successful results on these tests that the FDA will allow for a drug product's label to include claims based on demonstration of meaningful abuse-det- errent properties.

This proposal 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.

This will help advance safe patient care by ensuring that abuse-deter- rent versions of available opioid analgesic drug products are covered, including those containing nonopioid drug substances to form a single drug product.

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.

Prior 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.

Summaries, headlines and scores are AI-generated from the official bill text. How we score bills. Source: NYS Open Legislation.