Amendment #1002 to H4000
Substance Abuse Deterrent Medications
Mr. Golden of Lowell moves to amend the bill in section 78, by inserting at the end thereof the following new language:
Section 13 of Chapter 17 of the General Laws, as appearing in the 2012 Official Edition, is hereby amended by inserting after the third paragraph the following 2 new paragraphs:-
“The commission shall also prepare a drug formulary of abuse-deterrent interchangeable opioid drug products, which shall be adopted by regulations of the department, and which shall list commercially available abuse-deterrent products that serve as equivalent alternatives to non- abuse-deterrent opioid products. Said formulary shall include formulations of opioid drugs of schedules II through V that are pharmaceutically and therapeutically equivalent and interchangeable, and that also incorporate abuse-deterrent technology satisfying at least two of the following criteria:
(i) Physical or chemical barriers that can prevent chewing, crushing, cutting, grating, grinding, melting or other physical manipulations that enable abuse, or resist extraction of the opioid by common solvents such as water, alcohol or other organic solvents;
(ii) Agonist/antagonist combinations that interfere with, reduce or defeat the euphoria associated with abuse;
(iii) Aversion qualities that produce an unpleasant effect if the dosage form is manipulated or altered, or a higher dosage than directed is used;
(iv) Delivery systems that, pursuant to United States Food and Drug Administration guidance, offer resistance to abuse;
(v) Product techniques that limit opioid activity until transformed in the gastrointestinal tract; or
(vi) A combination of two or more of the above methods to deter abuse, or
(vii) Other techniques as may be identified or recommended by the Food and Drug Administration that offer significant abuse deterrence.
In preparing a formulary of abuse-deterrent opioid drug products that are interchangeable with non-abuse-deterrent opioid drug products, the commission shall consider information contained in an abuse-deterrent opioid drug product’s labeling approved by the United States Food and Drug Administration, and other regulatory and guidance documents distributed by said administration. A determination of interchangeability between two drug products shall not require that both products incorporate the same methods of abuse-deterrence, but that the products must have at least the same degree (tier) of FDA-approved abuse-deterrent labeling claims. Inclusion of a drug on this formulary shall not be construed to authorize labeling or marketing claims of abuse deterrence potential, unless such claims are authorized by the Food and Drug Administration.”
Said section 13 is hereby further amended by striking from lines 29, 34, and 39 the word “formulary” and inserting in place thereof, in each instance, the word:- “formularies”
Section 18 of Chapter 94C of the General Laws, as appearing in the 2012 Official Edition, is hereby amended by inserting after subsection (e) the following new subsection:-
“(f) A prescription shall not be issued or filled for any opioid drug product or substance contained in schedule II to IV that is formulated as a non-abuse-deterrent opioid drug, as defined in section 12D of chapter 112 of the General Laws, unless the drug formulary commission has determined, pursuant to section 13 of chapter 17 of the General Laws, that no abuse-deterrent interchangeable opioid drug product is available as a substitute for the indicated product or substance.”
Section 12D of Chapter 112 of the General Laws, as appearing in the 2012 Official Edition, is hereby amended by inserting after the definition of “Practitioner” the following two new definitions:-
“Non-abuse-deterrent opioid drug product”, any opioid drug product that is approved for medical use but that does not meet the requirements for listing as a abuse-deterrent interchangeable opioid drug product.
“Abuse-deterrent interchangeable opioid drug product”, an opioid drug that is rated by the U.S. Food and Drug Administration as pharmaceutically and therapeutically equivalent to the prescribed product or substance, and that also incorporates abuse-deterrent technology and has been identified as such by the drug formulary commission in accordance with section 13 of chapter 17 of the General Laws.”
Said section 12D is hereby further amended by inserting after the word “practitioner” in line 32 the following new paragraph:-
“Notwithstanding the substitution requirements of this section, or any brand name or “no substitution” indication by the practitioner, the pharmacist shall not, in any case, dispense an opioid drug of schedule II to schedule IV that is formulated as a non-abuse-deterrent opioid drug product, unless the drug formulary commission has determined that no abuse-deterrent interchangeable opioid drug product is available as a substitute for the indicated product or substance.
Chapter 176O of the General Laws, as appearing in the 2012 Official Edition, is hereby amended by inserting after Section 16 the following new section:
Section 16A. A carrier may not exclude or deny reimbursement for abuse-deterrent opioid drug products dispensed in accordance with section 12D of chapter 112 of the General Laws solely due to the cost of said abuse-deterrent products; provided however that this section shall not be construed to prohibit a carrier from applying prior authorization requirements and utilization reviews for opioid drug products when such measures, and any service denials made pursuant thereto, do not require treatment failure(s) of non-abuse deterrent product(s) in order access abuse-deterrent products.