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Determination of Regulatory Review Period for VYLOY Patent Extension

The FDA has determined the regulatory review period for VYLOY, a human biological product, for patent extension purposes. The Agency is publishing this notice as required by law due to patent extension applications submitted to the USPTO. Comments regarding date corrections must be submitted by June 2, 2026, and petitions for due diligence determinations may be filed by September 30, 2026.

Determination of Regulatory Review Period for Patent Extension; ENFLONSIA

The FDA has determined the regulatory review period for ENFLONSIA, a human biological product, and published this notice as required by 21 CFR Part 60. The notice allows any person to submit comments correcting dates by June 2, 2026, and any interested party may petition FDA by September 30, 2026 regarding due diligence during the review period.

Determination of Regulatory Review Period for Purposes of Patent Extension; EMRELIS

The FDA has determined the regulatory review period for EMRELIS, a human biological product, and published this notice as required by law for patent extension purposes. The determination affects the calculation of patent term extension under federal law. Comments on the determination may be submitted until June 2, 2026, and petitions regarding due diligence may be filed until September 30, 2026.

Determination of Regulatory Review Period for HYMPAVZI Patent Extension

The FDA has determined the regulatory review period for HYMPAVZI, a human biological product, and published this notice as required by law. The determination was made in connection with an application to the USPTO for extension of a patent claiming the product. Interested parties may submit comments or petitions regarding the determination.

Customer Service Satisfaction Survey Collection

The FDA is seeking public comments on a proposed information collection for customer service satisfaction surveys. Under the Paperwork Reduction Act of 1995, federal agencies must publish notice and allow 60 days for public comment on proposed collections. Comments are due by June 2, 2026.

Determination of Regulatory Review Period for INJECTAFER Patent Extension

FDA has determined the regulatory review period for INJECTAFER (ferric carboxymaltose injection) and published this notice as required by law. The determination is needed for the USPTO to calculate patent term extension under the Hatch-Waxman Act. Comments on the calculation may be submitted by June 2, 2026; petitions regarding due diligence may be filed by September 30, 2026.

Medicare Advantage and Part D Contract Year 2027 Final Rule

CMS issued a final rule updating Medicare Advantage and Part D programs for Contract Year 2027. The rule modifies the Star Ratings system by removing 11 administrative measures and adding a depression screening measure, while codifying Inflation Reduction Act provisions including elimination of the coverage gap phase and reduced annual out-of-pocket thresholds. The rule impacts Medicare Advantage organizations, Part D sponsors, and approximately 66 million Medicare beneficiaries.

FY 2027 Hospice Wage Index Payment Rate Update and Quality Reporting Program Proposed Rule

CMS issued proposed rule CMS-1851-P to update Medicare hospice payments for FY 2027, proposing a 2.4% payment rate increase ($785M estimated impact). The rule includes new Service and Spending Variation Index (SSVI) for oversight, mandatory hospice election addendum requirements, and changes to physician designee discharge authority.

FY 2027 Inpatient Rehabilitation Facility Prospective Payment System Proposed Rule

CMS issued a proposed rule updating Medicare payment policies for Inpatient Rehabilitation Facilities for FY 2027, proposing a 2.4% payment rate increase based on a 3.2% market basket update less a 0.8% productivity adjustment. The rule includes an estimated $355 million increase in IRF payments, updates to outlier thresholds and case-mix weights, and proposes clarifying that all therapies must be initiated within 36 hours of IRF admission.

Medicare Inpatient Psychiatric Facility Payment System Updates for FY 2027

CMS issued a proposed rule to update Medicare payment policies for Inpatient Psychiatric Facilities (IPF) for FY 2027, proposing a 2.3% payment rate update representing a $50 million increase in total payments. The rule includes proposals to reform outlier payment policy, remove two measures from the IPF Quality Reporting Program, and implement a standardized IPF patient assessment instrument.