The Rheum Advocate: November 13, 2025

From the DC Office: Administration Acts on Visa Fees, FDA Targets Biosimilars, as Shutdown Hits Historic Length

This week, in DC, guidance for new fees for H-1B visas does not offer a clear exception for physicians as hoped. Additionally, Congress continues to grapple with the shutdown, and the FDA updates guidance on biosimilars. The ACR’s work on these issues is laid out here.

ACR Urges Widespread Exemption of $100K H-1B Visa Fee for Healthcare Providers
The American College of Rheumatology (ACR) is actively advocating for healthcare workers to receive a broad exemption from the newly imposed $100,000 filing fee on certain new H-1B visa petitions, announced in September 2025.

This fee poses a major concern for international medical graduates (IMGs) working in the U.S., especially in specialties like rheumatology where workforce shortages already jeopardize patient access.

USCIS guidance clarifies the fee applies to new petitions filed after September 21, 2025, for beneficiaries outside the U.S. without a valid H-1B visa. Existing visa holders and certain petition amendments or status changes within the U.S. are generally exempt. The fee may be waived via the National Interest Waiver only under stringent criteria—proof that the beneficiary’s presence benefits U.S. national interest, no American worker can fill the role, no security risks exist, and fee payment would undermine U.S. interests.

The ACR shares concerns echoed by the American Medical Association (AMA) and American Hospital Association (AHA) that the fee will worsen physician shortages, particularly in rural and underserved areas where roughly 64% of IMGs practice.

IMGs constitute 23% of U.S. physicians and fill critical care gaps, especially outside major metro regions. To protect patient access and the healthcare workforce, ACR is urging members to contact Congress and support efforts for a broad exemption for healthcare professionals. The ACR believes the fee’s unintended impact threatens healthcare delivery and continues to engage with the Department of Homeland Security to secure relief. Members can visit the ACR Advocacy Portal to learn how to participate.

Government Shutdown Now Longest in U.S. History
The federal government shutdown began October 1, 2025, due to Congress’s failure to pass a discretionary appropriations bill to fund government operations. The House passed a short-term funding resolution, but the Senate did not approve it or an alternative measure by the deadline. This marks the longest government closure in American history, surpassing the previous record of 35 days set in late 2018 during the Trump administration. Late Monday, the Senate passed an agreement on a continuing resolution (CR) to reopen the government, extending federal funding and authorities that expired in September through January 30, 2026. The House will now reconvene in D.C. to consider that package.

The shutdown has halted funding for all nonessential federal programs and agencies. While healthcare services continue, many Americans outside the healthcare system face impacts. For example, 42 million people relying on Supplemental Nutrition Assistance Program (SNAP) benefits have seen reduced disbursement due to lapsed funding. Staffing shortages among unpaid air traffic controllers have prompted flight reductions ahead of the busy Thanksgiving travel season.

Election Results and Shutdown Negotiations
Recent election outcomes have emboldened Democrats in Congress to push for the reinstatement of Affordable Care Act (ACA) subsidies as a condition for reopening government funding. Republicans acknowledge the election results but remain divided on their approach, complicating compromise. Polls show growing public frustration predominantly blaming congressional Republicans and the White House for the prolonged shutdown. These shifting dynamics make the future of the Senate’s negotiated package in the House unclear but at 1:30 am Wednesday morning the House Rules Committee approved a resolution allowing the chamber to take up the Senate-passed funding package to reopen the government signaling confidence in immediate action.

Medicare Reimbursements and Telehealth
Since October 21, the Centers for Medicare & Medicaid Services (CMS) resumed processing Medicare claims after a temporary hold during the shutdown. Providers may continue telehealth services but should inform patients that claims for telehealth after October 1 may not be reimbursed unless Congress passes legislation for retroactive payments.

The CR passed by the Senate on Monday extends federal funding and authorities that expired in September through January 30, 2026. One of those expired authorities is telehealth flexibilities which would be reinstated through January under this legislation. Additionally, any telehealth claims that were put on hold since the lapse in funding would be paid retroactively, starting from October 1. Additionally, claims that were previously paid at a lower rate because geographic adjustments had expired may also be reprocessed and corrected if the House passes this legislation. The ACR is prioritizing advocacy to restore telehealth flexibilities essential for rheumatology care.

Members are encouraged to support telehealth through the ACR’s Legislative Action Center: Ensure Telemedicine Continues to Support Patient Care!

FDA Releases New Draft Guidance on Biosimilars
Biosimilars provide competition to originator biologics, which are drugs that contain active substances derived from biological sources and are frequently used to treat rheumatic disease. Unlike small molecule generic medicines where the active ingredient is chemically identical to the originator drug, biosimilars are never completely identical to those biologics they are developed with reference to. This scientific reality has been the basis of regulatory hurdles biosimilar developers need to clear to obtain marketing authorization. Biosimilar candidates must evidence ‘biosimilarity’ with the originator product to regulators. In practice, regulators, including the U.S. Food and Drug Administration (FDA), have typically required comparative efficacy studies, or clinical comparability studies, to be carried out to meet this requirement. This entails conducting expensive and time-consuming ‘phase three’ clinical trials with patients.

The FDA has a degree of discretion over how it enables biosimilar developers to demonstrate biosimilarity. However, guidance it issued in 2015, while not binding, effectively recognized carrying out clinical comparability studies as a necessary part of that process, with the onus on developers to provide scientific evidence to justify a departure from that approach. However, in draft new guidance, the FDA has shifted its position, outlining how biosimilar developers can demonstrate biosimilarity without necessarily having to undertake a clinical comparability study. The FDA’s updated position aligns with that of other major medicines regulators in Europe.

ACR is assessing this shift with an eye on patient safety and welcomes member feedback on the topic through advocacy@rheumatology.org.

CMS Finalizes 2026 Medicare Physician Fee Schedule: ACR Applauds Payment Increase, but Urges Long-Term Reform

On October 31, the Centers for Medicare & Medicaid Services (CMS) released its Calendar Year (CY) 2026 Medicare Physician Fee Schedule (PFS) final rule, which finalizes proposals related to Medicare physician payment and the Quality Payment Program (QPP). These policies will be effective on January 1, 2026. Among others, the ACR provided comments on the following provisions.

Fee Schedule Provisions

Physician Reimbursement

CMS finalized two separate conversion factors for 2026: one for non-Alternative Payment Model (APM) participant where the CF went from $32.35 to $33.40 and $33.57 for qualifying APM participants. This will give an overall 3% increase to payments for rheumatology practices.

• ACR Position: The ACR believes this increase is a positive step in the reimbursement for the treatment of complex patients with rheumatologic conditions, but believes there needs to be continuous conversation with CMS to work on a permanent fix beyond the proposed amount to at least keep pace with the MEI and to collaborate with Congress to enact a permanent update for physician payments.

Efficiency Adjustment

CMS finalized an efficiency adjustment structure which will decrease the work Relative Value Units (RVU) and physician intraservice time for approximately 7,000 non-time-based services that are expected to gain productivity over time.

• ACR Position: The ACR recognizes there needs to be more work on the overall relative value structure but there are significant concerns regarding the potential downstream impact of the adjustment proposal every three years. The ACR will continue to engage CMS in dialogue and welcome the opportunity to contribute clinical expertise to help shape an alternative solution that will be fair to both physicians and their patients.

Practice Expense Methodology

CMS is reducing the amount of indirect practice expenses allocated per work Relative Value Unit (RVU) for facility services to 50% of the amount allocated for non-facility services (i.e., office vs hospital setting) for many services.

• ACR Position: The ACR is concerned that this will significantly lower reimbursement for practices in the facility setting and exacerbate already insufficient Medicare reimbursement for rheumatology services.

Telehealth

CMS is permanently adopting proposals to define “direct supervision” to include virtual presence via real-time audio/video communications for certain services and to allow teaching physicians to use virtual presence for purposes of billing for services involving residents in teaching settings.

• ACR Position: While the ACR supports both these proposals, we continue to encourage CMS to work with Congress to permanently extend all regulatory flexibilities on telehealth reimbursement. The ACR also continues to call for CMS to remove all restrictions on payment parity and remove any barriers to interstate licensure that bar providers from treating beneficiaries across state lines.

Average Sales Price (ASP)

CMS clarified that units of selected drugs sold at the Maximum Fair Price (MFP) are included in the calculation of ASP, effective January 1, 2026. For quarters in which Medicare payment is based on MFP, the Medicare Part B Drug Payment Limit File will display the MFP-based payment limit.

• ACR Position: The ACR is concerned that this provision will lower the current ASP for Part B drugs and thus exacerbate the financial issues that rheumatologists are already experiencing when procuring and infusing many of these drugs. It also may pose additional access issues for patients by forcing more providers in private practice to either consolidate or close their doors. The ACR will continue to call for CMS to create a reimbursement floor so that ASP reductions from MFPs do not push reimbursement below drug acquisition and administration costs.

Quality Payment Program

MIPS performance categories will be maintained at their current weightings: The quality performance category will be weighted at 30% and the cost performance category will be weighted by 30%. Promoting interoperability and Improvement Activities performance categories will maintain their respective 25% and 15% weights.

CMS will maintain the data completeness threshold for the MIPS Quality Performance Category at 75% for the 2025 through 2028 performance years.

• ACR Position: ACR supports both provisions.

ACR/ARP members should email the ACR’s advocacy team at advocacy@rheumatology.org with any questions and comments they may have. We will monitor the rule’s implementation and serve as an educational resource for members on its provisions and the impact they will have on rheumatology.

President Will Harvey’s Vision: Advocacy First

William (Will) F. Harvey, MD, MSc, FACR has begun his term as the new President of the American College of Rheumatology (ACR), stepping into a leadership role during one of the most challenging times in the specialty’s recent history. Dr. Harvey, a practicing rheumatologist, educator, and researcher at Tufts Medical Center, is shaping his agenda around advocacy, member engagement, and hope for the future.

Dr. Harvey sees advocacy as both his passion and the essential pillar for rheumatology’s survival. With the field facing cuts in research funding, changes to Medicare and Medicaid, and insurance battles, he believes that “doubling-down on our principles” is the only way forward. He urges the ACR to remain ruthlessly apolitical, focusing on bipartisan solutions that support high-quality care rather than political divides. For more read: Meet New ACR President William (Will) F. Harvey in The Rheumatologist.

ACR Board Greenlights New Health Policy Framework

The ACR Board of Directors approved three additions and two timely updates to the College’s Health Policy Statements at their October meeting. These statements were considered out of cycle (2026 updates will be reviewed as scheduled in February) to protect and advance the interests of members of the College and the rheumatology community.

As the official public policy positions of the College, the ACR Health Policy Statements inform Congress, federal agencies, and partner organizations of the ACRs policy positions and recommendations in areas impacting rheumatology practice and patient care.

Recent Board action takes into account emerging issues impacting our community reflected in the following policy positions:

• Medicaid: Voices concern with cuts to funding for state Medicaid programs over the next 10 years and the threat to access to care particularly for pediatric and rural patients. Supports Medicaid payment parity with Medicare, increased reimbursement for pediatric rheumatology care, and reforms that improve equity and care coordination. Cautions administrative barriers to Medicaid access and enrollment.
• Rights of Immigrants and Visa Holders Voices concerns with new fees and policies that restrict movement of those serving the healthcare workforce with visas, visitors to the U.S., and immigrants. Highlights the positive impact of the global nature of the rheumatology workforce. Adds support for policies that remove barriers to access for visa and green card holders to the U.S. workforce and policies that foster global collaboration.
• State Prescription Drug Affordability Boards (PDABs): Urges caution in PDAB implementation to avoid upper payment limits limiting access for patients to essential rheumatology medications. Encourages transparent methodologies and stakeholder feedback in PDAB implementation.
• Vaccines and Immunizations: Expands statement to explicitly support access to vaccination as an essential measure to protect immunocompromised individuals with rheumatic disease, policies that promote vaccination among school-age children, and unimpeded access to vaccines for patients, caregivers, and healthcare workers. Also updates guidance in reaction to changes to the CDC Advisory Committee on Immunization Practices (ACIP).
• Workforce Equity, Access, and Optimization: States that every person in the U.S. should be represented when recruiting, educating and promoting clinicians, care teams and researchers, designing clinical trials, and designing patient care models. Opposes discrimination and retaliation in healthcare and academic settings.

Read the updated Health Policy Statements >

Watch: New SLE Clinical Guideline Overview

The ACR unveiled its updated guideline for the treatment of systemic lupus erythematosus (SLE), offering critical new recommendations and deeper guidance for both clinicians and patients. Unveiled at the 2025 ACR Convergence conference, this release highlights evidence-based strategies aimed at improving patient outcomes, minimizing treatment toxicity, and supporting shared decision-making between providers and those living with lupus. Watch a video summary reviewing the key changes, practical impacts for patients and clinicians, and what the next steps might look like in lupus care:

Visit Clinical Practice Guidelines for direct access to the SLE treatment recommendations and related lupus resources.

Complete the 2025 ACR Rheumatology Physician and Faculty Survey by November 18!

Check your inbox—and your spam folder—for an email reminder sent from acollins@ecgmc.com. This message includes your link to the ACR Rheumatology Physician and Faculty Survey, conducted in partnership with ECG Management Consultants. Your input helps ACR better understand and support the professional and practice needs of rheumatologists. Please complete the survey as soon as possible. All responses are blinded and confidential.

If you have not yet done so, take a moment to share your practice manager’s name and email by November 17. Practice managers will then receive an invitation to the ACR Leader Survey, which focuses on key issues in private practice management—staffing, operations, and fair compensation. Participating managers will receive an aggregate summary report early next year to benchmark and improve practice performance.

Read more about both surveys in The Rheumatologist.

Together, we can shape the future of rheumatology.

Call for Interested Practice Sites – Help Pilot Age-Friendly Rheumatology Care

As part of an initiative to develop tools that improve the care of older adults living with rheumatic diseases, the ACR is looking for interested practices, as well as subject matter experts to serve on a working group.

Selected practice sites will integrate age-friendly care strategies into their practices and collect data on implementation and patient impact; practices will receive $7,500 to support the effort. Private/community rheumatology practices as well as academic-based practices are encouraged to indicate interest via email to practice@rheumatology.org by November 26.

See details for practices and/or individuals interested in being involved in this project >