THE NYS DEPARTMENT OF HEALTH’S CLARIFICATION OF BILLING PRACTICES FOR PHYSICIANS WHO DISPENSE PRESCRIPTION DRUGS UNDER THE MEDICAID PROGRAM IS VALID; THE CLARIFICATION IS NOT A “RULE” AND IS NOT VOID FOR VAGUENESS (THIRD DEPT).

The Third Department, in a full-fledged opinion by Justice Garry, determined a clarification issued by the respondent NYS Department of Health, was valid, was not a rule, and was not void for vagueness. The clarification concerned the billing practices for physicians who dispense prescription drugs:

As it regularly does, respondent [NYS Department of Health] took steps to clarify appropriate billing practices. This included issuance of the July 2022 edition of its official newsletter of the New York State Medicaid Program — Medicaid Update. In a section entitled “Policy Clarification for Practitioner Dispensing” … , which purported to “supersede[ ] previous communications on this topic,” respondent stated that the state Medicaid program reimburses for drugs furnished by practitioners to their patients on the basis of the acquisition cost to the practitioner and that additional registration or ownership of a pharmacy is not required. The clarification went on to provide that practitioners billing for medications dispensed to its fee-for-service patients should use the medical claim format and that practitioners still participating in managed care should check with the patient’s health plan to determine the billing policy for prescription drugs dispensed directly to patients. Reportedly confused by the alleged change in billing practice, petitioner subsequently contacted respondent for further clarification. In response, respondent reiterated that a practitioner that dispenses drugs to their patients is not considered a pharmacy under either statutory or enrollment requirements and therefore should not be enrolled or billing as a pharmacy provider.

Petitioner then commenced this CPLR article 78 proceeding to annul the clarification as an unpromulgated rule, unconstitutionally vague, irrational and violative of section 504 the Rehabilitation Act of 1973 (see 29 USC § 794). Citing anticipated financial losses for expenses attendant to medication dispensing, that is, beyond the acquisition cost of the drugs, petitioner argued that respondent’s alleged new rule would force it to cease its physician-dispensing services altogether, thereby both irrationally depriving cancer patients from effective treatment and discriminating against them by effectively precluding them from meaningful access to the provider of their choice. Matter of North Shore Hematology-Oncology Assoc., P.C. v New York State Dept. of Health, 2025 NY Slip Op 01985, Third Dept 4-3-25