WISeR Model Prior Authorization Technical Correction
CMS issued a correction notice correcting typographical and technical errors in the July 1, 2025 Federal Register notice regarding the WISeR (Wasteful and Inappropriate Services Reduction) Model prior authorization requirements. The corrections refine the lists of Local Coverage Determination (LCD) codes for specific services including Epidural Steroid Injections, Vertebral Compression Fracture procedures, Fusion surgeries, and Sleep Apnea treatments. The corrections are effective April 6, 2026, with applicability to WISeR items and services implemented on January 1, 2026.
Public Data Asset Release Under OPEN Government Data Act
CMS announced the release of seven public data assets containing Original Medicare utilization and payment data aggregated by provider and service, including physician services, inpatient/outpatient hospitals, Part D prescribers, DMEPOS, and Medicaid provider spending. The datasets are released in open, machine-readable formats under an open license pursuant to the OPEN Government Data Act. CMS evaluated privacy protections under HIPAA, 21st Century Cures Act, and 42 CFR Part 2, determining the data has been de-identified and appropriately limited to mitigate re-identification risk.
CMS PRA Information Collection Request - Annual EPSDT Participation Report
The Centers for Medicare & Medicaid Services (CMS) published a Paperwork Reduction Act (PRA) notice inviting public comment on the revision of Form CMS-416, the Annual Early and Periodic Screening, Diagnostic and Treatment (EPSDT) Participation Report. The notice summarizes the proposed data collection to assess state effectiveness in providing child health screening and treatment services to Medicaid-eligible children. Comments must be submitted to the OMB desk officer by May 6, 2026.
PRA Notice - Skilled Nursing Facility Physician Certification Information Collection
CMS published a 60-day notice under the Paperwork Reduction Act requesting public comment on an information collection related to physician certifications and recertifications in skilled nursing facilities under Section 1814(a) of the Social Security Act. The notice includes burden estimates and invites comments on the necessity, utility, and accuracy of the proposed information collection. Comments must be received by June 5, 2026.
Medicare Advantage and Part D Drug Benefit Changes
CMS issued a final rule effective June 1, 2026 (applicable to coverage beginning January 1, 2027) implementing Medicare Advantage (Part C), Medicare Part D, and Medicare cost plan changes. The rule codifies Inflation Reduction Act section 11201 changes to Part D benefit design, including new coverage phases, out-of-pocket thresholds, and the Manufacturer Discount Program replacing the Coverage Gap Discount Program.
FY2027 IRF Prospective Payment Rate Updates and Policy Changes
CMS proposes updates to Inpatient Rehabilitation Facility (IRF) prospective payment rates for Federal fiscal year 2027, including the third year of rural adjustment phaseout. The proposed rule includes new requirements for therapy initiation timing (within 36 hours of admission), functional status documentation on preadmission screenings, and interdisciplinary team meeting requirements. Comments are due June 1, 2026.
Hospice Wage Index and Payment Update for FY2027
CMS has issued a proposed rule updating the hospice wage index, payment rates, and aggregate cap amount for Fiscal Year 2027. The proposed rule would require hospices to provide the hospice election statement addendum to all Medicare beneficiaries at the time of hospice election. Comments are due by June 1, 2026.
WISeR Prior Authorization Implementation Delay
CMS issued a notice delaying implementation of prior authorization requirements for two services under the Wasteful and Inappropriate Services Reduction (WISeR) model: Deep Brain Stimulation for Essential Tremor and Parkinson's Disease (NCD 160.24) and Percutaneous Image-Guided Lumbar Decompression for Spinal Stenosis (NCD 150.13). The original January 1, 2026 implementation date is postponed until a future date to be announced. This is a routine administrative delay to allow additional time for operational readiness.
Generic Omeprazole Oral Paste Approved for Horse Gastric Ulcers
The FDA approved Gastrobim (omeprazole) oral paste as a generic equivalent to Gastrogard for the treatment and prevention of gastric ulcers in horses and foals four weeks of age and older. Sponsored by Bimeda Animal Health Ltd. of Ireland, the drug was determined bioequivalent to the brand-name product approved in 1999. Gastrobim is available only by prescription from a licensed veterinarian.
Maria Anzures-Camarena Permanent Debarment - FDA Drug Applications
FDA issued a permanent debarment order for Maria Anzures-Camarena, prohibiting her from submitting or assisting in the preparation of drug applications to the agency. The debarment stems from her felony conviction related to drug application matters. All FDA-regulated drug product applications submitted by or on behalf of Ms. Anzures-Camarena are permanently barred.
Bernardo Garmendia Permanent Debarment Order
The FDA issued a permanent debarment order against Bernardo Garmendia, preventing him from providing services in any capacity related to drug marketing or distribution under the FD&C Act. The order, effective March 14, 2025, follows Garmendia's felony conviction for a drug-related offense, denying his request for a hearing. Pharmaceutical companies and clinical investigators must ensure no engagement with debarred parties.
FDA Permanent Debarment Order - John Warrington Kosolcharoen
FDA issued a final permanent debarment order against John Warrington Kosolcharoen, barring him from participating in any way in the submission of applications for FDA approval or accreditation. The debarment relates to activities concerning FDA-regulated products, specifically applications under the Federal Food, Drug, and Cosmetic Act.
Permanent Debarment Order - Miguel Angel Montalvo Villa
The FDA issued a Final Debarment Order permanently excluding Miguel Angel Montalvo Villa from submitting or providing assistance in the preparation of drug applications under section 306(a) or (b) of the FD&C Act. The debarment follows a conviction under federal law related to drug product approval. This action prohibits Montalvo Villa from any role in drug application submissions to FDA.
Matthew Teltser Permanent Debarment Order
The FDA issued a final order permanently debarring Matthew Teltser from providing services to any person or entity that has an approved or pending drug application. The debarment prohibits Teltser from directly or indirectly participating in any FDA-regulated drug business activities. This enforcement action (Docket No. FDA-2025-N-1956) took effect on February 6, 2026.
WHO World Health Day Campaign: Global Commitment to Science
WHO released its World Health Day 2026 campaign theme "Together for health. Stand with science." The campaign calls on people globally to renew commitment to science and international collaboration as drivers of health progress. The announcement highlights achievements including a 40% reduction in maternal mortality since 2000 and over 154 million children's lives saved through immunization over 50 years.
WHO head emergencies visit Lebanon reaffirms support to health system
WHO's Health Emergencies Programme Director Dr. Chikwe Ihekweazu completed a three-day visit to Lebanon reaffirming WHO's support for the national health emergency response amid escalating conflict pressures. WHO launched a $30 million Flash Appeal, with $10 million allocated for Lebanon, to address urgent health needs across five affected countries. Since March 2, 2026, 92 attacks on healthcare have been reported, resulting in 137 injuries and 53 deaths.
Alepsal Unavailable - Therapeutic Alternatives Identified
ANSM announces temporary unavailability of Alepsal (phenobarbital/caffeine anti-epileptic medication) due to supply disruptions affecting all dosages. Manufacturer Teofarma reports difficulties linked to a raw material supplier change, with normal supply expected by summer 2026. Three caffeine-free alternatives have been identified in coordination with the French neurology professional society: Gardenal 10mg and 100mg, and Phenobarbital Richard 100mg.