N.Y. Comp. Codes R. & Regs. tit. 9 § 9960.1

Current through Register Vol. 46, No. 36, September 4, 2024

Section 9960.1 - Covered drug

(a) Definitions. For purposes of this Part, the following terms shall have the following meanings:

(1) Department means the New York State Department of Health.

(2) Commissioner means the New York State Commissioner of Health.

(3) EPIC means the Elderly Pharmaceutical Insurance Coverage Program established pursuant to section 19-K of the Executive Law.

(4) Eligible participant means a person deemed eligible to receive benefits coverage under EPIC.

(5) Licensed physician means a legally authorized prescriber of drugs.

(6) Excluded drug means any drug package, dosage form or administration deemed to be excluded as a covered benefit under EPIC pursuant to section 9960.3 of this Part.

(7) Drug Application Information form means a form developed by the department for the purpose of collecting information from licensed physicians and used by the department in determining coverage of excluded drugs under EPIC.

(8) Contractor means the private, not-for-profit, or proprietary corporation which has entered into a contract with EPIC to assist in carrying out the provisions of EPIC.

(b) To be eligible for an insurance benefit, a prescription drug shall be dispensed subject to a legally authorized prescription from a registered pharmacy.

(c) Insulin, insulin syringes and insulin needles shall qualify as a covered drug benefit.

(d) Dispensing of a covered drug shall be in quantities ordered by the prescriber not to exceed a 30-day supply or 100 doses, whichever is greater.

(e) A covered drug shall not include any drug product:

(1)

(i) where the Federal Food and Drug Administration (FDA) of the Federal Department of Health and Human Services (HHS) has issued any notice of a proposed order indicating that there is a lack of substantial evidence that such drug product will have the effect it purports or is represented to have under the conditions of use prescribed, recommended or suggested in its labeling until the secretary of HHS withdraws such order; or

(ii) which the FDA determines to be identical, related, or similar to the drug product identified in subparagraph (i) of this paragraph until such time as the secretary of HHS withdraws the order identified in subparagraph (i) of this paragraph.

(2) marketed by a company without FDA approval where the FDA finds its approval is required;

(3) which is generally available without a physician's prescription, including vitamins, except for insulin;

(4) properly administered only by a physician, dentist or podiatrist as indicated in the official labeling of such drug product;

(5) generally available free of charge to eligible participants;

(6) marketed as a therapeutic agent with official labeling which states that the product is contraindicated by virtue of age or therapeutic condition for program participants;

(7) any device for the aid or correction of vision; or

(8) for which a pharmaceutically and therapeutically equivalent drug is available in a less expensive package, or form of dosage or administration as identified and determined according to specified procedures delineated in section 9960.3 of this Part.

N.Y. Comp. Codes R. & Regs. Tit. 9 § 9960.1