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Medicaid Provider Update: High-Cost Medicaid Drug Billing

Published Date: 2025-10-27

Billing Requirements for Medicaid-Covered Drugs

Highmark Wholecare is committed to compliance with Medicaid billing standards for high-cost drugs administered and billed by providers for outlier payment or single case agreements. In alignment with the Department of Human Services (DHS) and CMS Medicaid Drug Rebate Program, Highmark Wholecare requires the following for drug rebate eligibility.

General Billing Guidelines

Claims must be submitted using 837 Professional or 837 Institutional formats.
Drugs billed via HCPCS codes (e.g., J-codes) must also adhere to the following requirements:
- Accurate National Drug Codes (NDCs) and corresponding J-codes are included.
- The drug appears on a single claim line, with no other services.
- Drug administration is billed separately.
- 340B-purchased drugs must include the UD modifier.
  - Exception: Any provider identified by the Department as a 340B-covered entity must dispense or administer non-340B purchased gene therapy products unless otherwise approved to Medicaid beneficiaries.

Special Guidance: CMS Cell and Gene Therapy (CGT) Access Model for Sickle Cell Disease

For therapies like Lyfgenia and Casgevy, the following conditions apply:

Providers must be registered with the Center for International Blood & Marrow Transplant Research (CIBMTR) and participate in a CMS-specified study.
These therapies are excluded from 340B purchasing under the model.

Please ensure your billing teams are trained in these procedures and modifiers. Accurate claims submission is essential for timely payment and compliance with federal rebate programs.