A10478 Summary:

Add 3216-a, Ins L
Provides for patient access to FDA approved abuse-deterrent technology to help combat opioid abuse.
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A10478 Actions:

05/27/2016referred to insurance
06/01/2016reported referred to codes
06/06/2016reported referred to rules
06/16/2016rules report cal.461
06/16/2016substituted by s6962a
 05/11/2016PRINT NUMBER 6962A
 05/17/2016PASSED SENATE
 05/17/2016referred to insurance
 06/16/2016substituted for a10478
 06/16/2016ordered to third reading rules cal.461
 06/16/2016passed assembly
 06/16/2016returned to senate
 11/28/2016VETOED MEMO.283
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A10478 Memo:

submitted in accordance with Assembly Rule III, Sec 1(f)
BILL NUMBER: A10478       REVISED MEMO 06/07/2016
  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 non-opioid 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.
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A10478 Text:

                STATE OF NEW YORK
                   IN ASSEMBLY
                                      May 27, 2016
        Introduced by M. of A. CUSICK -- read once and referred to the Committee
          on Insurance
        AN  ACT to amend the insurance law, in relation to the use of abuse-det-
          errent 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:

     1    Section 1. The insurance law is amended by adding a new section 3216-a
     2  to read as follows:
     3    § 3216-a.  Access to abuse-deterrent opioid medications. (a) An insur-
     4  ance carrier or health plan shall provide  coverage  on  its  formulary,
     5  drug  list  or  other lists of similar construct for at least one abuse-
     6  deterrent opioid analgesic drug  product  per  opioid  analgesic  active
     7  ingredient.
     8    (1)  Cost-sharing for brand name abuse-deterrent opioid analgesic drug
     9  products covered pursuant to this section shall not  exceed  the  lowest
    10  cost-sharing  level  applied  to  brand  name non-abuse deterrent opioid
    11  drugs covered under the applicable health plan or policy.
    12    (2) Cost-sharing for generic  abuse-deterrent  opioid  analgesic  drug
    13  products  covered  pursuant  to this section shall not exceed the lowest
    14  cost-sharing level applied to generic non-abuse deterrent  opioid  drugs
    15  covered under the applicable health plan or policy.
    16    (3)  An increase in patient cost-sharing or disincentives for prescri-
    17  bers or dispensers shall not be allowed to achieve compliance with  this
    18  section.
    19    (b)  Any  prior-authorization requirements or other utilization review
    20  measures for opioid analgesics, and any service  denials  made  pursuant
    21  thereto, shall not require use of opioid analgesic drug products without
    22  abuse-deterrent  properties  in  order  to access abuse-deterrent opioid
    23  analgesic drug products.
    24    (c) Definitions. As used in this section:
    25    (1) "Opioid analgesic drug product" means a drug in the  opioid  anal-
    26  gesic  drug  class  prescribed to treat moderate to severe pain or other
    27  conditions, whether in immediate release or extended long acting release
         EXPLANATION--Matter in italics (underscored) is new; matter in brackets
                              [ ] is old law to be omitted.

        A. 10478                            2
     1  form and whether or not combined with other drug substances  to  form  a
     2  single drug product or other dosage form.
     3    (2)  "Abuse  deterrent opioid analgesic drug product" means a brand or
     4  generic opioid analgesic drug product approved by the federal  food  and
     5  drug administration with abuse-deterrence labeling claims indicating its
     6  abuse-deterrent properties are expected to deter or reduce its abuse.
     7    (3)  "Cost-sharing"  means any coverage limit, copayment, coinsurance,
     8  deductible or other out-of-pocket patient expense requirements.
     9    § 2. This act shall take effect on the one hundred twentieth day after
    10  it shall have become  a  law,  and  shall  apply  to  all  policies  and
    11  contracts issued, renewed, modified, altered or amended on or after such
    12  date.
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