CMS Issues Physician Fee Schedule Final Rule

On November 1, 2024, the Centers for Medicare and Medicaid Services (CMS) issued the Physician Fee Schedule Final Rule (Final Rule), which is scheduled to be published in the Federal Register on December 9, 2024. In addition to finalizing payment rates, the Final Rule includes a variety of provisions that may impact managed care pharmacy. 

Medicare Prescription Drug Inflation Rebate Program 

• For Part B, CMS finalized policies and processes on the following: Determining when to apply a coinsurance adjustment by comparing quarterly pricing files and inflation-adjusted payment amounts; 
• Removing 340B units for professional claims with 2024 dates of service;
• Reconciling rebate amounts to account for revised information, calculation error, or misreporting and excluding units of refundable single dose container or single-use package drugs subject to discarded drug refunds; and 
• Establishing a civil money penalty process for failure to timely pay the rebate amount. 

For Part D, CMS finalized policies and processes on the following: 

• Identifying the benchmark period for a Part D rebatable drug when there is missing manufacturer reported Average Manufacturer Price (AMP) data;
• Reconciling rebate amounts to account for revised information, calculation error, or misreporting, including the circumstances that may trigger such a reconciliation; and 
• Establishing a civil money penalty process for failure to timely pay the rebate amount. 

Digital Mental Health Treatment Devices 

CMS finalized policies around Medicare payment for digital mental health treatment devices (DMHTDs): 

• DMHTDs are cleared under section 510(k) of the Federal Food, Drug and Cosmetic Act, or granted de no novo authorization by FDA and furnished incident to professional behavioral health services and are used in conjunction with ongoing behavioral health care treatment. 
• Three new HCPCS codes were created to describe these services. 

Electronic prescribing for controlled substances (EPCS) for a covered Part D drug 

The Final Rule includes provisions that: 

• Extend the date after which prescriptions written for a beneficiary in a long-term care (LTC) facility would be included in determining EPCS Program compliance, from January 1, 2025, to January 1, 2028. This aligns with the date by which the new NCPDP SCRIPT standard version 2023011 will be required. 

Preventive services 

• The Final Rule includes a coverage expansion of the hepatitis B vaccine and colorectal cancer screening. 
• CMS finalized payment under Part B as an additional preventive service for Pre-Exposure Prophylaxis (PrEP) to Prevent Human Immunodeficiency Virus (HIV), following September’s release of the National Coverage Determination. The Final Rule also includes a fee schedule for Drugs Covered as Additional Preventive Services (DCAPS drugs). 

See the Final Rule and associated fact sheets for additional details. The Final Rule is effective on January 1, 2025. 

More on This Topic:

• Final Rule
• Fact Sheet
• Inflation Rebate Program Fact Sheet
• National Coverage Determination

For questions, please reach to Vicky Jucelin.