S T A T E   O F   N E W   Y O R K
________________________________________________________________________

                                 7427--A

                       2015-2016 Regular Sessions

                          I N  A S S E M B L Y

                              May 12, 2015
                               ___________

Introduced  by  M. of A. CUSICK, SIMANOWITZ, BRINDISI -- Multi-Sponsored
  by -- M. of A.  LUPARDO -- read once and referred to the Committee  on
  Higher  Education  --  committee  discharged,  bill  amended,  ordered
  reprinted as amended and recommitted to said committee

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. The public health law is amended by adding  a  new  section
3340 to read as follows:
  S  3340.  SUBSTITUTION  OF OPIOIDS WITH ABUSE-DETERRENT TECHNOLOGY. 1.
NOTWITHSTANDING THE PROVISIONS OF SECTION SIXTY-EIGHT HUNDRED  SIXTEEN-A
OF  THE  EDUCATION LAW, NO PHARMACIST SHALL INTERCHANGE OR SUBSTITUTE AN
ABUSE-DETERRENT OPIOID ANALGESIC DRUG PRODUCT, BRAND OR GENERIC, WITH AN
OPIOID ANALGESIC DRUG PRODUCT LACKING  ABUSE-DETERRENT  PROPERTIES  WHEN
THE PRESCRIBER WRITES OR ELECTRONICALLY NOTATES "DISPENSE AS WRITTEN" OR
"DAW"  ON  THE  PRESCRIPTION, WITHOUT OBTAINING A NEW PRESCRIPTION FOR A
NON-ABUSE DETERRENT OPIOID DRUG FROM THE PRESCRIBER.  ANY  SUBSTITUTABLE
OPIOID  DRUG PRODUCT SHALL CONTAIN THE SAME OPIOID ACTIVE PHARMACEUTICAL
INGREDIENT AND THE SAME DRUG  RELEASE  CHARACTERISTICS  WITH  REGARD  TO
IMMEDIATE  RELEASE, OR EXTENDED RELEASE LONG ACTING PROPERTIES. A DETER-
MINATION OF INTERCHANGEABILITY BETWEEN TWO ABUSE-DETERRENT OPIOID  ANAL-
GESIC DRUG PRODUCTS SHALL NOT REQUIRE THAT BOTH PRODUCTS INCORPORATE THE
SAME METHODS OF ABUSE-DETERRENCE, BUT THAT THE OPIOID DRUG PRODUCTS HAVE
THE SAME LEVEL OF FDA-APPROVED ABUSE DETERRENCE LABELING CLAIMS.
  2. DEFINITIONS. AS USED IN THIS SECTION:
  (A)  "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 RELEASE LONG ACTING

 EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets
                      [ ] is old law to be omitted.
                                                           LBD08948-07-5

              

A. 7427--A                          2

FORM  AND  WHETHER  OR NOT COMBINED WITH OTHER DRUG SUBSTANCES TO FORM A
SINGLE DRUG PRODUCT OR OTHER DOSAGE FORM.
  (B)  "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.
  (C)  "INTERCHANGE OR SUBSTITUTION OF AN OPIOID DRUG" MEANS THE SUBSTI-
TUTION OF ANY ABUSE-DETERRENT OPIOID DRUG  PRODUCT,  BRAND  OR  GENERIC,
WITH AN OPIOID ANALGESIC DRUG LACKING ABUSE-DETERRENT PROPERTIES.
  (D)  "PHARMACIST"  INCLUDES  ANY PHARMACIST DISPENSING DRUGS UNDER THE
JURISDICTION OF THE STATE BOARD OF PHARMACY, INCLUDING BUT  NOT  LIMITED
TO, COMMUNITY PHARMACISTS, PHARMACISTS IN HOSPITAL-BASED PHARMACIES WHEN
FILLING  PRESCRIPTIONS FOR INPATIENT OR OUTPATIENT CARE, AND PHARMACISTS
IN MAIL ORDER PHARMACIES LICENSED BY THE  STATE  TO  DISTRIBUTE  IN  THE
STATE.
  S  2.  The  insurance law is amended by adding a new section 3216-a to
read as follows:
  S 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  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 PRESCRI-
BERS 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  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.
  S 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.