N.Y. Comp. Codes R. & Regs. tit. 12 § 441.1

Current through Register Vol. 46, No. 45, November 2, 2024

Section 441.1 - Definitions

(a) "Compound drug" means a drug that is created by combining one or more active pharmaceutical ingredients, and/or one or more inactive ingredients, to meet specific patient medical needs that are not met with U.S. Food and Drug Administration ("FDA")-approved prescription drugs, FDA-approved non-prescription drugs, or other drugs commercially available in the marketplace. For the purposes of this Part, a compound drug shall, at all times, be subject to federal law governing compounding, including title 21, United State Code, sections 353a, 353a-1 and 353b. A compound drug that incorporates a drug identified in Phase A or B of the Formulary or FDA-approved non-prescription drug may only be dispensed for the route of administration (oral, topical or systemic) for which it is FDA-approved. Prior authorization is required for all compound drugs prior to prescription and/or dispensing of such drug.

(b) "Accident or injury" means any accident occurring in the course of employment or any alleged accident that results in personal injury which has caused or will cause a loss of time from regular duties of one day beyond the working day or shift on which the accident or alleged accident occurred, or which has required or will require medical treatment beyond ordinary first aid or more than two treatments by a person rendering first aid; or any disease or alleged disease claimed to have been caused by the nature of the employment and contracted therein. An accident or injury may also be referred to as a Disability event.

(c) "Dispense," "dispensed," or "dispensing" means

(1) the furnishing of a drug upon a medical prescription, or

(2) the furnishing of drugs directly to a patient by a medical provider acting within the scope of his or her practice and pursuant to the dispensing limitations set forth in section 6807 (2) of the Education Law.

(d) "FDA-approved drug" means a prescription or nonprescription drug that has been approved by the FDA under the federal Food, Drug, and Cosmetic Act, title 21, United States Code, section 301 et seq. for the route of administration (oral, topical or systemic) prescribed.

(e) "FDA OTC Monograph" means the data standards manual (DSM) established by the FDA setting forth acceptable ingredients, doses, formulations, and labeling for a class of over the counter drugs.

(f) "Generic drug" means an FDA-approved drug that is therapeutically equivalent to a brand name drug, as determined by the FDA's designation of the drug with the Therapeutic Equivalence Evaluation Code designation as an "A" product in the "Approved Drug Products with Therapeutic Equivalence Evaluations" (commonly referred to as the Orange Book), irrespective of dosage for the route of administration (oral, topical or systemic) prescribed. A brand name drug may not be dispensed when a generic version of the same active ingredient is commercially available in a different strength/dosage. For example, if a drug is available generically in 5mg and 10mg tablets and brand name only in 7.5mg tablets, the 7.5mg would be considered non-formulary and may not be dispensed without prior authorization.

(g) "Carrier's Physician" means a physician or physicians, licensed by New York State, or the appropriate state where the professional practices, who is:

1. employed or contracted by the insurance carrier or self-insured employer; or

2. is employed by a URAC accredited company retained by the insurance carrier or self-insured employer through a contract to review claims requests for non-formulary agents and advise the insurance carrier or self-insured employer; and

3. is not employed or contracted by the carrier or self-insured employer's pharmacy benefits network.

(h) "Formulary" means the New York Workers' Compensation Formulary which is a list of prescription and over-the-counter drugs for work-related injuries that is incorporated by reference in section 441.2 of this Part and that must be used to prescribe medication for all accidents or injuries. The Formulary includes medications available in Phase A and B; and, also includes a list of medications available for Perioperative periods that may be prescribed without Prior Authorization during the applicable Phase or Perioperative period.

(i) "Non-Formulary drug" means a drug that does not appear on the Formulary and which is one of the following: an FDA-approved prescription drug; an FDA-approved nonprescription drug; or a nonprescription over the counter drug that is marketed pursuant to an FDA OTC Monograph. Non-Formulary drugs do not include non-FDA approved drugs and such drugs may not be prescribed.

(j) "Over-the -counter drug" means a drug that is available without a prescription. The carrier or pharmacy benefits manager should be billed for over-the-counter drugs included in the Formulary. Over-the- counter drugs that are not included on the Formulary require Prior Authorization or direct payment by the claimant (which thereafter may be submitted to the carrier in a reimbursement request).

(k) "Perioperative Formulary drug" are those drugs listed in the Perioperative Drug Formulary where the drug is prescribed for work-related injuries in accordance with subdivision (c) of section 441.4 herein.

(l) "Phase A drug" are those drugs listed in Phase A of the Formulary. Phase A drugs may be prescribed and dispensed without Prior Authorization and Medical Treatment Guidelines corroboration when prescribed in accordance with subdivision (a) of section 441.4 herein.

(m) "Phase B drug" are those drugs listed in Phase B of the Formulary and may be prescribed and dispensed without Prior Authorization and Medical Treatment Guidelines corroboration when prescribed in accordance with subdivision (b) of section 441.4 herein.

(n) "Prior Authorization process" means the pre-approval review procedure initiated by the medical provider that is conducted prior to the prescribing or dispensing of a Non-Formulary drug; a brand-name drug when a Generic drug is available; or a Formulary drug prescribed not in accordance with the applicable Phase of the Formulary or in accordance with applicable Medical Treatment Guidelines.

(o) "Prior Authorization" means the carrier's approval of a Prior Authorization request initiated by the medical provider.

(p) "Refill" means a fill of a prescription that is authorized at the point in time when the provider writes the original prescription and the number of such fills is explicitly included in the original prescription.

(q) "Renewal" means a prescription that the claimant has been taking but for which there are no available refills and must be reinitiated by the provider writing a new prescription.

(r) "URAC" means the Washington DC-based non-profit organization of that name that helps promote health care quality through the accreditation of organizations involved in medical care services.

N.Y. Comp. Codes R. & Regs. Tit. 12 § 441.1

Adopted New York State Register June 5, 2019/Volume XLI, Issue 22, eff. 6/5/2019

Amended New York State Register September 1, 2021/Volume XLIII, Issue 35, eff. 9/1/2021