Objective:

To highlight federal actions by CMS and FDA that may impact physician practice in 2026.

Approach:

• 2026 Medicare Physician Fee Schedule Final Rule: Finalized Medicare payment policies under the Physician Fee Schedule effective January 1, 2026, with separate conversion factors for qualifying and non-qualifying alternative payment model participants.
• 2026 Medicare Advantage and Part D Program Changes: Implemented changes in prescription drug coverage, including protections for adult vaccines and insulin products.
• 2026 Hospital Outpatient and Ambulatory Surgical Center Payment Policies: Updated payment policies for hospital outpatient and ambulatory surgical center services, affecting approximately 4,000 hospitals and 6,000 ASCs.
• Electronic Prior Authorization Capabilities Finalized: Introduced electronic prescribing and prior authorization capabilities to reduce administrative burden and improve care delivery.
• CMS Proposes Electronic Prior Authorization Requirements for Drugs: Proposed extending prior authorization requirements for drugs, including electronic support and transparency measures.
• Approval of Oral GLP-1 Therapy for Weight Management: FDA approved Foundayo for weight management in adults with obesity, marking a rapid approval process.
• Expanded Approval of Teplizumab for Type 1 Diabetes: FDA granted accelerated approval for Tzield to delay insulin production decline in pediatric patients with Stage 3 type 1 diabetes.
• Over-the-Counter Continuous Glucose Monitor Cleared for Pediatric Use: FDA cleared Dexcom’s Stelo Glucose Biosensor System for over-the-counter use in children aged 2 years and older.

Key Findings:

• Separate conversion factors established for Medicare payment policies.
• Changes in Medicare Advantage and Part D enhance drug coverage.
• Payment updates for outpatient and surgical services reflect quality reporting.
• Electronic prior authorization aims to ease provider burden.
• New drug approvals include significant therapies for weight management and diabetes.

Interpretation:

The actions taken by CMS and FDA are expected to influence various aspects of healthcare delivery and reimbursement in 2026.

Conclusion:

The outlined actions represent significant regulatory changes that may affect clinical operations and patient access in 2026.