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A Look Back at 2024 Regulatory Developments

From the College  |  January 6, 2025

In 2024, several key federal healthcare regulations and policy developments shaped the landscape of the practice of rheumatology. Spanning a broad range of areas, from health insurance to privacy protections, these regulations aimed to improve access to care, reduce costs and enhance the quality of healthcare services. The changes touch on multiple aspects important to practices, including physician reimbursement, the Inflation Reduction Act, the interchangeability status of biosimilars and more.

Physician Reimbursement

On Nov. 1, 2024, the Centers for Medicare & Medicaid Services (CMS) released the calendar year 2025 Revisions to Payment Policies Under the Physician Fee Schedule (PFS) and Other Revisions to Medicare Part B Final Rule.

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This rule includes significant changes to Medicare physician payment and the Quality Payment Program. The 2025 conversion factor is set at $32.3465, a reduction of more than 2.83% from 2024. The CMS also finalized policies related to telemedicine (although extension of COVID-era flexibilities require an act of Congress), the Merit-Based Incentive Payment System (MIPS) and the Medicare Shared Savings Program. Key updates include expansion of the G2211 add-on code for complexity and efforts to move MIPS reporting toward the MIPS Value Pathways by 2029.

In our comments, the ACR supported the provisions related to MIPS and complex biologics, but strongly dissented against CMS’ further cuts to physician reimbursement and its inactivity on telemedicine.

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Medicare Drug Price Negotiation

The Inflation Reduction Act of 2022 (IRA), signed into law by President Biden in August 2022, includes several provisions to lower prescription drug costs for people with Medicare and to reduce drug spending by the federal government.

One of the IRA’s key drug-related provisions is a requirement for the Secretary of Health & Human Services to negotiate prices with drug companies for certain drugs covered under Medicare Part D (starting in 2026) and Part B (starting in 2028). In August 2024, the CMS selected the first round of 10 drugs, including Enbrel, whose reduced pricing will take effect in 2026. The list of up to 15 Part D drugs for the second round of price negotiation is due to be announced by Feb. 1, 2025.

The future of the IRA and Medicare Drug Price Negotiation Program is unclear. The Trump Administration will be responsible for administering the program after he is inaugurated on Jan. 20. Although President Trump supported Medicare price negotiation in the past, it’s unclear where either he or Mehmet Oz, MD (the nominee for CMS Administrator), stand on the issue now. The Trump campaign backed off a similar proposal that would tie drug prices paid in the U.S. to prices paid by other countries.

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Filed under:GuidanceLegal Updates Tagged with:Regulation

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