The Centers for Medicare & Medicaid Services and the US Food and Drug Administration issued several policy decisions, approvals, and safety actions with potential implications for physician practice in 2026. The following 10-item framework highlights federal actions that may affect reimbursement, prescribing, patient access, and clinical operations across multiple specialties.
2026 Medicare Physician Fee Schedule Final Rule — On October 31, 2025, the Centers for Medicare & Medicaid Services issued the Calendar Year 2026 Medicare Physician Fee Schedule final rule, which finalized Medicare payment policies under the Physician Fee Schedule and other Medicare Part B policy changes effective on or after January 1, 2026. According to CMS, the rule establishes separate conversion factors for qualifying alternative payment model participants and physicians and practitioners who are not qualifying participants. CMS said the qualifying APM conversion factor includes a statutory 0.75% update, while the nonqualifying APM conversion factor includes a statutory 0.25% update. CMS also said both conversion factors reflect a one-year statutory 2.50% increase for 2026 and an estimated 0.49% adjustment related to finalized changes in work relative value units.
2026 Medicare Advantage and Part D Program Changes — On April 4, 2025, the Centers for Medicare & Medicaid Services issued the Contract Year 2026 Medicare Advantage and Part D final rule, which addresses Medicare Advantage, Medicare Part D, Medicare cost plans, and Programs of All-Inclusive Care for the Elderly. According to CMS, the rule implements changes involving prescription drug coverage, the Medicare Prescription Payment Plan, dual-eligible special needs plans, Star Ratings, and the Medicare Drug Price Negotiation Program. CMS also said the rule codifies statutory Part D protections that eliminate deductible and cost-sharing requirements for covered adult vaccines recommended by the Advisory Committee on Immunization Practices and limit cost sharing for covered insulin products.
2026 Hospital Outpatient and Ambulatory Surgical Center Payment Policies — On November 21, 2025, the Centers for Medicare & Medicaid Services issued updates to Medicare payment policies and rates for hospital outpatient and ambulatory surgical center services in the Calendar Year 2026 Hospital Outpatient Prospective Payment System and Ambulatory Surgical Center Payment System final rule with comment period. According to CMS, the payment policies affect approximately 4,000 hospitals and approximately 6,000 ASCs. CMS finalized a 2.6% update to OPPS payment rates for hospitals meeting applicable quality reporting requirements and a 2.6% update to ASC payment rates for ASCs meeting relevant quality reporting requirements. CMS said both updates reflect a 3.3% market-basket increase reduced by a 0.7-percentage-point productivity adjustment.
Electronic Prior Authorization Capabilities Finalized in Certified Health IT — In the FY 2026 IPPS/LTCH PPS final rule, CMS included an Assistant Secretary for Technology Policy/Office of the National Coordinator for Health Information Technology electronic prescribing, real-time prescription benefit, and electronic prior authorization rider, known as HTI-4. According to CMS, the rider focuses on improving care delivery and reducing administrative burden through the exchange of clinical and administrative information. CMS said the rule finalizes updates to the ONC Health IT Certification Program intended to advance health care providers’ ability to use electronic prescribing, conduct real-time prescription benefit checks, and engage in electronic prior authorization. CMS further stated that the capabilities build on and complement earlier CMS policies and support the department’s efforts to ease provider burden and help patients receive timely, evidence-based care.
CMS Proposes Electronic Prior Authorization Requirements for Drugs — On April 10, 2026, CMS released the 2026 CMS Interoperability Standards and Prior Authorization for Drugs proposed rule. According to CMS, the proposal would extend many of the prior authorization requirements established in its 2024 final rule for non-drug items and services to prior authorizations for drugs. CMS also proposes requiring impacted payers to support electronic prior authorization for certain drugs, issue prior authorization decisions within specified timeframes, and increase transparency around drug prior authorization requests and decisions.
Approval of Oral GLP-1 Therapy for Weight Management — The US Food and Drug Administration approved Foundayo (orforglipron), in combination with a reduced-calorie diet and increased physical activity, to reduce excess body weight and maintain long-term weight reduction in adults with obesity or adults with overweight and at least one weight-related comorbid condition. According to the FDA, Foundayo is a glucagon-like peptide-1 receptor agonist in tablet form that is taken once daily. The agency reported that Foundayo was the first new molecular entity approved under the Commissioner’s National Priority Voucher pilot program and that the decision, issued 50 days after the application was filed, marked the fastest approval of a new molecular entity since 2002.
Expanded Approval of Teplizumab for Type 1 Diabetes — The FDA granted accelerated approval to Tzield (teplizumab) for a new indication: delaying the decline of insulin production in pediatric patients aged 8 through 17 years who were recently diagnosed with Stage 3 type 1 diabetes. According to the FDA, Tzield is the first FDA-approved treatment for this indication. The approval was based on an adequate and well-controlled clinical trial in which Tzield demonstrated a statistically significant effect on C-peptide, a surrogate endpoint the FDA determined was reasonably likely to predict clinical benefit. A required postapproval study is ongoing to verify the anticipated clinical benefit.
Over-the-Counter Continuous Glucose Monitor Cleared for Pediatric Use — On June 12, 2026, the FDA cleared Dexcom’s Stelo Glucose Biosensor System for over-the-counter use by people aged 2 years and older who do not use insulin. The agency described Stelo as the first nonprescription continuous glucose monitor cleared for children. The FDA previously cleared the system for over-the-counter use by adults aged 18 years and older in March 2024.
Additional OTC Naloxone Nasal Spray Approved — The FDA approved Rextovy, a 4-mg naloxone hydrochloride nasal spray, for over-the-counter use in the emergency treatment of opioid overdose. According to the agency, consumers may purchase the product without a prescription at locations such as pharmacies and convenience stores or online. The FDA stated that naloxone rapidly reverses the effects of opioid overdose and is the standard treatment for opioid overdose. The agency said Rextovy contains the same active ingredient as other naloxone nasal sprays and that the availability of multiple approved formulations expands access and market availability and provides alternative sourcing options.
Orlistat Labeling Updated for Kidney Stones and Kidney Injury — The FDA approved changes to the Drug Facts label for the OTC weight loss drug alli (orlistat) 60 mg capsules to warn of the risks of acute kidney injury, which the agency described as a rare side effect. The updated labeling advises consumers to ask a health care provider before using alli if they have ever had kidney disease or kidney stones. It also instructs consumers to stop using alli and ask a doctor if they develop symptoms of kidney injury or kidney stones, including back or groin pain, painful urination, blood in the urine, swelling of the feet or legs, or less frequent urination. According to the FDA, the risk of renal injury is now described consistently across the labeling for all FDA-approved orlistat products, including OTC and higher-strength prescription formulations.
Sources: Centers for Medicare & Medicaid Services, US Food and Drug Administration