High
CMS
Updates Medicare payment rates for inpatient rehabilitation facilities, phases out the rural adjustment, and revises quality reporting and admission timing requirements for FY 2027. This final rule from the Centers for Medicare & Medicaid Services (CMS) updates the prospective payment rates for...
High
CMS
Rule updates hospice wage index, payment rates, and quality measures while finalizing hospice election statement addendum requirement for all Medicare beneficiaries. The Centers for Medicare & Medicaid Services (CMS) has issued a final rule updating the hospice wage index, payment rates, and...
High
HL7
FHIR
The new HL7 FHIR Implementation Guide enables scalable, interoperable consent management across healthcare data exchange networks. The HL7 FHIR at Scale Taskforce (FAST) has released the Scalable Consent Management Implementation Guide to address growing challenges in consent enforcement across...
High
CMS
The rule sets payment rates for skilled nursing facilities in FY 2027 while refining quality measure requirements under both the SNF QRP and VBP programs. CMS has issued a final rule updating the Skilled Nursing Facility Prospective Payment System (PPS) and consolidated billing policies for...
High
FDA
Global regulators converge on protecting data confidentiality, integrity, and availability for AI-enabled medical devices but apply distinct regulatory architectures, with FDA integrating cybersecurity into quality systems and design controls. The United States FDA, European Union Medical Device...
High
CMS
CMS introduces a voluntary interoperability framework encouraging gradual adoption while establishing baseline technical requirements for network participation, raising concerns about equitable access for resource-constrained providers. The Centers for Medicare & Medicaid Services (CMS) has...
Notable
HHS
HRSA is proceeding with the 340B Rebate Model Pilot Program starting January 1, targeting 25 potentially eligible drugs despite covered entities' concerns about administrative burden. The Health Resources & Services Administration (HRSA) is advancing its revised 340B Rebate Model Pilot Program,...
Notable
CMS
CMS locks in inpatient hospital payment update at 2.3%, below earlier proposal but projecting hundreds of millions in higher hospital payments from rule changes. The Centers for Medicare & Medicaid Services (CMS) has finalized the Inpatient Prospective Payment System (IPPS) rule, establishing a...
Notable
HHS
💬 Comments close in 21 days (Aug 24)
HRSA announces a pilot implementing rebates instead of upfront discounts to achieve 340B ceiling prices, building on stakeholder input from prior RFI. The Health Resources and Services Administration (HRSA) has announced the availability of a revised 340B Rebate Model Pilot Program, implementing...
Notable
HHS
💬 Open for industry feedback
The update adds NIST security attestations and clarifies project close-out procedures while maintaining current burden estimates. The National Institute on Drug Abuse (NIDA) has published a 60-day comment request for proposed revisions to the data use certification process for the NIH Brain...
Notable
HHS
💬 Comments close in 53 days (Sep 25)
The proposal merges two public health forms into a single Onsite Health Intervention Form and adds limited sharing of health data with DHS to ensure continuity of care for unaccompanied refugee minors. The Administration for Children and Families (ACF), through its Office of Refugee Resettlement...
Notable
FDA
💬 Comments close in 42 days (Sep 14)
The FDA proposes to require foreign tobacco product establishment owners and operators to register and list their products, closing current gaps in Agency oversight. The FDA is proposing regulations to establish the format, content, and procedures for tobacco product establishment registration...