New York regulations
Title 9 Part 9960
Executive Department
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9 NYCRR 9960.1 - Covered drug
No later Register activity identified in this check.
Dates and status
- Compiling agency
- Executive Department
- Text status
- Phase2b Dequote Reversal
- Register checked through
- July 29, 2026/Vol. XLVIII, Issue 30 (2026-07-29)
- Activity status
- No later Register activity identified in this check.
- Source snapshot
- May 19, 2026
(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.
9 NYCRR 9960.2 - Process for allowing coverage of excluded drugs
No later Register activity identified in this check.
Dates and status
- Compiling agency
- Executive Department
- Text status
- Source receipt
- Compiled text through
- May 15, 2022
- Register checked through
- July 29, 2026/Vol. XLVIII, Issue 30 (2026-07-29)
- Activity status
- No later Register activity identified in this check.
- Source snapshot
- Jun 6, 2026
(a)Request for coverage.
(1)Any drug package, or form of dosage or administration excluded from coverage as a benefit under EPIC pursuant to section 9960.3 of this Part may be allowed to be dispensed to a specific eligible participant based upon a written request for coverage by a licensed physician and a legal prescription.
(2)Each request for coverage shall be supported by a written certification and specific reasons why an excluded drug package or form of dosage or administration is considered by a licensed physician to be medically indicated for treatment of a specific patient.
(3)Requests for coverage pursuant to paragraph (1) of this subdivision shall be made only by a licensed physician treating an eligible participant for whom such excluded drug benefit is considered to be medically indicated.
(4)All requests for coverage of an excluded drug benefit shall be supported by information submitted by a physician on a Drug Application Information form and submitted to the department. Telephone requests may be made to the department; however, all such telephone requests for information shall be followed by submission of the required information on a completed Drug Application Information form to facilitate proper review and disposition of each request.
(b)Drug Application Information form.
(1)Information to support a certification by a licensed physician as to the medical indication for treating an eligible participant with a drug considered to be an excluded drug shall be contained on a Drug Application Information form. Such information shall include the following:
(i)name of drug, dosage form, strength and name of marketer;
(ii)name and identification number of participant;
(iii)length of time physician has treated the participant;
(iv)name of illness/disease/condition being treated;
(v)length of time participant has been taking the drug requested;
(vi)list of other medications used to treat the participant;
(vii)specific reasons why requested drug is medically indicated;
(viii)medical consequences if excluded drug is not provided as a covered drug benefit;
(ix)identification and signature of the licensed physician treating the participant.
(2)Copies of the Drug Application Information form shall be made available by the department, or from local county offices for the aging or health departments, or the EPIC executive director or EPIC contractor.
(c)Decisions on coverage.
(1)Upon receipt of a completed Drug Application Information form submitted by a licensed physician, the department shall review the request and render a decision within three working days. Failure to render a decision within this time period shall not constitute approval by the department.
(2)Written notice of the decision shall be sent by the department to the licensed physician who requested coverage of an excluded drug for a particular eligible participant within seven working days following such decision. Similar written notice shall also be provided to the EPIC contractor by the EPIC executive director and to the participant to inform such person of this individual rights to be reimbursed for an excluded drug which is determined to be included as a covered benefit.
9 NYCRR 9960.3 - Procedures for determinations relating to package, dosage form or form of administration
No later Register activity identified in this check.
Dates and status
- Compiling agency
- Executive Department
- Text status
- Source receipt
- Compiled text through
- May 15, 2022
- Register checked through
- July 29, 2026/Vol. XLVIII, Issue 30 (2026-07-29)
- Activity status
- No later Register activity identified in this check.
- Source snapshot
- Jun 6, 2026
For purposes of designating a given package, dosage form or form of administration as excluded from coverage, the following shall apply:
(a)An initial determination based upon information and facts available, shall be made by the department utilizing such considerations as:
(1)the availability of low-cost alternative packaging, dosage form or forms of administration;
(2)any particular health needs of the EPIC population;
(3)the degree to which the packaging, dosage form or form of administration offers comfort, convenience or ease of administration at added cost;
(4)availability of pharmaceutically equivalent and therapeutically equivalent products for the covered population;
(5)any drug 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; or
(6)recommendations of the Technical Pharmacy Advisory Committee of the department, where appropriate, as to current pharmacy practice and drug marketing principles.
(b)The department shall notify the manufacturer(s) in writing of its intent to exclude a specific drug's packaging, dosage form or form of administration giving the reasons for the intended exclusion, together with the facts upon which the initial determination is based.
(c)The manufacturer(s) shall then have 15 days following receipt of notice of initial determination to notify the department in writing of intent to appeal the initial determination.
(1)Failure on the part of the manufacturer(s) to so notify the department of its intent to appeal within the 15 days, allows for immediate final determination to be made by the commissioner.
(2)If the manufacturer notifies the department of an intent to appeal, the manufacturer shall submit to the department, within 45 days of receiving the initial determination, all the information and documentation which forms the basis of the manufacturer's appeal.
(d)
(1)The department, within 15 days of receiving the manufacturer's basis for appeal, shall provide to the manufacturer any additional facts concerning the intent to exclude a drug product to support the initial determination.
(2)Within 10 days of receiving such additional facts, the manufacturer may submit to the department additional facts relevant to the drug package, or form of dosage or administration.
(3)Based upon all of the facts and information gathered and submitted, the commissioner shall make a final determination as to whether to designate a package, dosage form or form of administration, and exclude drug from program benefits coverage.
(4)As final determinations of excluded drugs relating to package, dosage form or form of administration are made by the commissioner pursuant to this subdivision, written notice of such determinations shall be made to the EPIC contractor by the EPIC executive director and to the drug manufacturer of such drug product.