Oct. 31, 2025: National Advocacy Update

FDA issues new guidance aimed at speeding biosimilar time to market and lower costs

On Oct. 29, the Department of Health and Human Services (HHS), along with the U.S. Food and Drug Administration (FDA) announced the release of new draft guidance aimed at accelerating the time to market for biosimilar drug products. The new guidance seeks to reduce the number of clinical studies needed to license a biosimilar medication, allowing biosimilar biologic products to come to market faster as well as reducing the cost of development.

FDA defines biosimilars as large molecule drugs that are “highly similar” to a reference biological drug product. Biosimilars for biologic products are like generic drug products to brand name medications. Biosimilars do not have clinically meaningful differences in efficacy, safety, purity or potency from their reference biologic product. Unlike other generic medications, FDA required comparative efficacy studies from biosimilar applicants as part of their demonstration of biosimilarity for approval, increasing the time to market and cost. The draft guidance from FDA suggests the agency will now change their approach to biosimilar review and no longer require comparative efficacy studies as part of an application for review for several biosimilar drug products, including therapeutic protein products.

AMA has long supported efforts to reduce drug costs by promoting the development of and easy access to biosimilar drug products. Biological drugs represent some of the highest cost drugs on the market, with biosimilars in many cases offering more affordable options for patients.
 
The AMA will continue to support efforts to lower costs of drug products for patients across all agencies, including by promoting development of lower cost therapeutic options, opposing anticompetitive actions by brand manufacturers, and opposing actions by pharmacy benefit managers that serve to increase drug costs for patients.

Bicameral legislation would extend alternative payment model incentive payments

Advancing federal legislation that helps incentivize the movement towards value-based care as an alternative to traditional fee-for-service (FFS) reimbursement models remains a principal advocacy goal for the AMA. In fact, the AMA has consistently supported legislation to extend crucial incentive payments created by Congress via the Medicare Access and CHIP Reauthorization Act (MACRA) that help physicians cover the steep fiscal costs associated with accepting two-sided financial risk as part of the transition to “advanced” alternative payment models (APM). Since Congress failed to enact legislation before Jan. 1, 2025, that would retain traditional APM bonus payments for the 2025 Performance Year, the AMA sent two letters (H.R. 786/S. 1460, PDF) on Oct. 30 supporting H.R. 786/S. 1460 (PDF), the Preserving Patient Access to Accountable Care Act.

This bipartisan, bicameral bill would reinstate the 3.53% Advanced APM incentive payments through 2027. MACRA stipulates that bonus payments are issued two years after the 12-month performance period. In addition to retaining these bonuses for the 2025 and 2026 performance years, the bill preserves a 50 percent “Qualifying APM Threshold,” or the amount of money that participants need to derive from the Advanced APM to even qualify for the incentive payments. Unfortunately, current law stipulates an increase in the qualifying revenue threshold to 75%, an amount that is too steep for the vast majority of APMs, including Accountable Care Organizations (ACOs), to achieve. Senators John Barrasso, MD (R-WY) and Sheldon Whitehouse (D-RI) introduced S. 1460, while Representatives Darin LaHood (R-IL) and Suzan DelBene (D-WA) are the lead sponsors of the House legislation.

Along with advocating for Medicare payment updates for all physicians tied to inflation as measured by the Medicare Economic Index, the AMA will continue to press bipartisan, bicameral federal lawmakers to prioritize the extension of the APM incentive payments in any potential, yet-to-be-determined health care package that might emerge before the end of 2025.

Reminder: MIPS targeted review filings due by Nov. 14

As a reminder, the Centers for Medicare & Medicaid Services (CMS) has released Merit-based Incentive Payment System (MIPS) payment adjustment information for the 2024 performance period/2026 MIPS payment year. Physicians’ 2024 MIPS final score determines the MIPS payment adjustment they will receive in 2026. A positive, negative, or neutral payment adjustment will be applied to the Medicare paid amount for covered professional services furnished in 2026. The AMA encourages physicians to review their final score as soon as possible. If CMS miscalculated your final score or payment adjustment, the deadline to file a targeted review is Nov. 14, 2025.

Some examples of circumstances that could prompt a targeted review:

• Data were submitted under the wrong TIN or National Provider Identifier (NPI).

• You have Qualifying APM Participant (QP) status and should not receive a MIPS payment adjustment.

• Performance categories were not automatically reweighted even though you qualify for reweighting due to extreme and uncontrollable circumstances.

To access MIPS payment adjustment information or file a Targeted Review, physicians must log into the Quality Payment Program (QPP) website—the same website utilized to submit 2024 MIPS data. CMS has clarified to the AMA that CMS is still reviewing Targeted Review requests during the government shutdown, but some determinations may be delayed as a result of the disruption.

The latest CMS guidance: Medicare claims processing

According to the most recent CMS guidance to Medicare Administrative Contractors, the Medicare claims hold is lifted with the exception of certain telehealth services and most claims should be flowing. The AMA had been communicating with CMS behind the scenes and urging the agency to clarify its guidance in light of significant confusion about which claims are being paid during the ongoing federal government shutdown. Please contact [email protected] if you continue to experience Medicare payment delays.

Nov. 5 webinar: Impact of the One Big Beautiful Bill Act on physicians and patients and how the AMA is preparing for state implementation

Significant changes to health care are on the horizon now that the One Big Beautiful Bill Act of 2025 (OBBBA) has been signed into law: Medicaid eligibility and financing, access to health insurance coverage through Affordable Care Act marketplaces, federal support of medical student loans, and Medicare payment. What do physicians need to know and how they can help their patients navigate these changes? How is the AMA helping state medical associations prepare for implementation? 

Register now to join the AMA for this Advocacy Insights webinar on OBBBA implementation on Nov. 5 at 7:30 p.m. Central time.  

Host: 

• David H. Aizuss, MD, chair, AMA Board of Trustees 

Speakers: 

• Todd Askew, senior vice president, AMA Advocacy 

• Emily Carroll, senior attorney, AMA Advocacy Resource Center 

• Annalia Michelman, senior attorney, AMA Advocacy Resource Center 

More articles in this issue

• Oct. 31, 2025: State Advocacy Update