10 CMS and FDA Actions Affecting Care in 2026 - Summary - MDSpire
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10 CMS and FDA Actions Affecting Care in 2026
From Medicare payment updates to drug approvals and device access, these federal actions may affect reimbursement, prescribing, patient access, and clinical workflows.
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.
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