STATE OF NEW YORK ________________________________________________________________________ 9115 IN ASSEMBLY January 21, 2020 ___________ Introduced by M. of A. M. L. MILLER -- read once and referred to the Committee on Insurance AN ACT to amend the insurance law and the public health law, in relation to off-label drug usage 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 3114 2 to read as follows: 3 § 3114. Off-label drug usage. (a) As used in this section, the follow- 4 ing terms shall have the following meanings: 5 (1) "Medical literature" means published scientific studies published 6 in any peer-reviewed national professional journal. 7 (2) "Standard reference compendia" means: 8 (A) The United States Pharmacopeia Drug Information; 9 (B) The American Medical Association Drug Evaluations; 10 (C) The American Hospital Formulary Service Drug Information; 11 (D) The National Comprehensive Cancer Network Drugs and Biologics 12 Compendium; 13 (E) The Thomson Micromedex DrugDex; or 14 (F) The Gold Standard/Elsevier Clinical Pharmacology. 15 (b) (1) Any contract or other arrangement entered into by a health 16 insurer offering health insurance under this chapter that provides 17 coverage for drugs shall exclude coverage of any such drug for a partic- 18 ular indication on the ground that the drug has not been approved by the 19 United States food and drug administration for that indication, if the 20 drug is recognized for treatment of the indication in one of the stand- 21 ard reference compendia, in the medical literature or has been success- 22 fully used for treatment previously by the insured for the same indi- 23 cation; provided, however, that nothing in this section shall be 24 construed to authorize the commissioner of health to approve any drug or 25 direct any person that issues an insurance policy to make payments for 26 the drug for a particular indication unless the drug is recognized for 27 treatment of the indication in one of the standard reference compendia, EXPLANATION--Matter in italics (underscored) is new; matter in brackets [ ] is old law to be omitted. LBD14454-01-9

A. 9115 2 1 in the medical literature or has been successfully used for treatment 2 previously by the insured for the same indication. 3 (2) Any coverage of a drug required by this section shall also include 4 medically necessary services associated with the administration of the 5 drug. 6 (3) This section shall not be construed to alter existing law with 7 regard to provisions limiting the coverage of drugs that have not been 8 approved by the United States food and drug administration. 9 (4) This section shall not be construed to require coverage for any 10 drug when the United States food and drug administration has determined 11 its use to be contra-indicated. 12 (5) This section shall not be construed to require coverage for exper- 13 imental drugs not otherwise approved for any indication by the United 14 States food and drug administration. 15 (6) Any dispute about coverage for off-label uses brought to the 16 commissioner of health shall be resolved by the appropriate grievance 17 process authorized by the department. 18 (7) The commissioner of health shall have the authority to direct any 19 person who issues an insurance policy to make payments required by this 20 section. 21 § 2. Subdivision 4 of section 280-a of the public health law is renum- 22 bered subdivision 5 and a new subdivision 4 is added to read as follows: 23 4. (a) No pharmacy benefit manager shall exclude coverage of any such 24 drug for a particular indication on the ground that the drug has not 25 been approved by the United States food and drug administration for that 26 indication, if the drug is recognized for treatment of the indication in 27 one of the standard reference compendia, in the medical literature or 28 has been successfully used for treatment previously by the insured for 29 the same indication; provided, however, that nothing in this subdivision 30 shall be construed to authorize the commissioner to approve any drug or 31 direct any pharmacy benefit manager to make payments for the drug for a 32 particular indication unless the drug is recognized for treatment of the 33 indication in one of the standard reference compendia, in the medical 34 literature or has been successfully used for treatment previously by the 35 insured for the same indication. 36 (b) Any coverage of a drug required by this subdivision shall also 37 include medically necessary services associated with the administration 38 of the drug. 39 (c) This subdivision shall not be construed to alter existing law with 40 regard to provisions limiting the coverage of drugs that have not been 41 approved by the United States food and drug administration. 42 (d) This subdivision shall not be construed to require coverage for 43 any drug when the United States food and drug administration has deter- 44 mined its use to be contra-indicated. 45 (e) This subdivision shall not be construed to require coverage for 46 experimental drugs not otherwise approved for any indication by the 47 United States food and drug administration. 48 (f) Any dispute about coverage for off-label uses brought to the 49 commissioner shall be resolved by the appropriate grievance process 50 authorized by the department. 51 (g) The commissioner shall have the authority to direct any pharmacy 52 benefit manager to make payments required by this subdivision. 53 (h) As used in this subdivision, the following terms shall have the 54 following meanings: 55 (1) "Medical literature" means published scientific studies published 56 in any peer-reviewed national professional journal.

A. 9115 3 1 (2) "Standard reference compendia" means: 2 (A) The United States Pharmacopeia Drug Information; 3 (B) The American Medical Association Drug Evaluations; 4 (C) The American Hospital Formulary Service Drug Information; 5 (D) The National Comprehensive Cancer Network Drugs and Biologics 6 Compendium; 7 (E) The Thomson Micromedex DrugDex; or 8 (F) The Gold Standard/Elsevier Clinical Pharmacology. 9 § 3. This act shall take effect on the ninetieth day after it shall 10 have become a law and shall apply to insurance policies issued, amended, 11 or renewed on or after such effective date.

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