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Proposed rules, draft specs, ballots and RFIs with an open comment window. Tracked proceedings keep their full history — from proposal to final decision — so you can follow where a requirement is heading.

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Closing soon Health and Human Services Department, Centers for Medicare & Medicaid Services RIN 0938-AV81

CMS proposes CY 2027 updates to ESRD PPS, AKI dialysis payment, and Quality Incentive Program

💬 Comments close in 8 days (Aug 24)

2 updates · 1 brief · view timeline →

Closing soon Health and Human Services Department, RIN 0936-AA16

HHS Seeks Input on Anti-Kickback Safe Harbors and Beneficiary Inducements Exceptions for Clinical Trial Remuneration

💬 Comments close in 8 days (Aug 24)

2 updates · 1 brief · view timeline →

Open for comment Health and Human Services Department, Centers for Medicare & Medicaid Services RIN 0938-AV83

CMS Proposes 2027 OPPS/ASC Payment Updates, Expands Prior Auth, and Issues HPT Standardization RFI

💬 Comments close in 15 days (Aug 31)

2 updates · 1 brief · view timeline →

Open for comment Health and Human Services Department, Centers for Medicare & Medicaid Services RIN 0938-AV80

CMS Proposes CY 2027 Home Health Payment Rates, Case-Mix Recalibration, and QRP/HHVBP Alignment Changes

💬 Comments close in 15 days (Aug 31)

2 updates · 1 brief · view timeline →

Open for comment Health and Human Services Department, Food and Drug Administration RIN 0910-AI94

FDA Proposes Streamlined Registration for Distributed Manufacturing Establishments

💬 Comments close in 26 days (Sep 11)

2 updates · 1 brief · view timeline →

Open for comment Health and Human Services Department, Centers for Medicare & Medicaid Services RIN 0938-AV82

CMS Proposes CY 2027 Physician Fee Schedule: Interoperability, Quality, and Payment Updates Open for Comment

💬 Comments close in 29 days (Sep 14)

2 updates · 1 brief · view timeline →

Open for comment Health and Human Services Department, Food and Drug Administration RIN 0910-AH59

FDA Proposes Extending Tobacco Establishment Registration and Product Listing to Foreign Facilities

💬 Comments close in 29 days (Sep 14)

2 updates · 1 brief · view timeline →

Open for comment Health and Human Services Department, Centers for Medicare & Medicaid Services RIN 0938-AW01

CMS Issues RFI to Update CLIA Regulations for 1988 Clinical Laboratory Standards

💬 Comments close in 29 days (Sep 14)

2 updates · 1 brief · view timeline →

Open for comment Health and Human Services Department, Food and Drug Administration

FDA Seeks Public Comment on Proposed Information Collection for Medical Device Voluntary Improvement Program

💬 Comments close in 30 days (Sep 15)

2 updates · 1 brief · view timeline →

Open for comment Health and Human Services Department, Food and Drug Administration

FDA Seeks Comment on Infant Formula Information Collection Requirements

💬 Comments close in 30 days (Sep 15)

2 updates · 1 brief · view timeline →

Open for comment Health and Human Services Department, Centers for Medicare & Medicaid Services RIN 0938-AV93

CMS Proposes Revised Medicaid Hold Harmless Threshold for Health Care-Related Taxes

💬 Comments close in 36 days (Sep 21)

2 updates · 1 brief · view timeline →

Open for comment Health and Human Services Department, Children and Families Administration

HHS Proposes Updated Mental Health and Health Intervention Forms for Refugee Children with DHS Data Sharing

💬 Comments close in 40 days (Sep 25)

2 updates · 1 brief · view timeline →

Open for comment Health and Human Services Department, Food and Drug Administration

FDA Proposes Reclassifying Digital Breast Tomosynthesis Systems from Class III to Class II

💬 Comments close in 54 days (Oct 9)

2 updates · 1 brief · view timeline →

Open for comment Health and Human Services Department, Centers for Medicare & Medicaid Services

CMS renews NCQA's deeming authority for MA HMOs and PPOs for 6 years

💬 Open for industry feedback

2 updates · 1 brief · view timeline →

Open for comment Health and Human Services Department, Food and Drug Administration

FDA Announces Medical Device User Fee Rates for FY 2027 Effective October 2026

💬 Open for industry feedback

2 updates · 1 brief · view timeline →

Open for comment Health and Human Services Department, Centers for Medicare & Medicaid Services

HHS Publishes Secretarial Comments on Battelle/CBE 2025 Annual Quality Measures Report to Congress

💬 Open for industry feedback

2 updates · 1 brief · view timeline →

Closed — awaiting final decision

Closed — awaiting decision Health and Human Services Department

ONC Opens 60-Day Comment Window on Proposed Information Collection Under Paperwork Reduction Act

💬 Comment window closed

5 updates · 1 brief · view timeline →

Other open comment items

Comment opportunities from non–Federal Register sources — no lifecycle tracking.

Must read HL7 FHIR 💬 Comments close in 1 day (Aug 17)

FHIR R6 Ballot 4 Opens for Normative Comment — Final Shape of the Next Major Release Takes Form

HL7's fourth normative ballot of FHIR R6 is the consensus gate that will define the stable, binding specification healthcare-IT teams must eventually certify against. HL7 International has opened an out-of-cycle Normative ballot for FHIR Release 6 (v6.0.0-ballot4), with voting and comments...

Sources

HL7 International · FHIR R6 Ballot 4 (Normative, out-of-cycle) — HL7 International · Jul 17
Notable HITRUST Industry 💬 Comments close in 1 day (Aug 17)

NCQA Opens Ad-Hoc Public Comment on Proposed HEDIS Measure Retirements for MY 2027

NCQA is soliciting feedback on retiring select HEDIS measures it deems low-value relative to reporting burden — a rare mid-cycle comment window that could reshape quality reporting obligations for health plans and providers. NCQA has announced a short, ad-hoc public comment window — August 3–17,...

Sources

NCQA · Public Comment Opens Soon: Proposed Retirement of Select HEDIS® Measures · Jul 22
Notable HHS 💬 Comments close in 8 days (Aug 24)

HRSA Launches 340B Rebate Model Pilot Program Implementation

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...

Sources

Health and Human Services Department, Health Resources and Services Administration · Notice Regarding 340B Rebate Model Pilot Program · Aug 3
Notable CMS HHS 💬 Comments close in 12 days (Aug 28)

CMS re-establishes OPM data matching program for ACA eligibility verification

CMS and state entities will use Office of Personnel Management data to verify ACA exchange eligibility and affordability program qualifications. The Centers for Medicare & Medicaid Services (CMS) has announced the re-establishment of a matching program with the Office of Personnel Management...

Sources

Health and Human Services Department, Centers for Medicare & Medicaid Services · Privacy Act of 1974; Matching Program · Jul 29
Notable HHS CMS 💬 Comments close in 19 days (Sep 4)

CMS re-establishes Privacy Act matching program with Department of War for ACA eligibility verification

CMS seeks public comment on renewed data matching to verify ACA minimum essential coverage eligibility via Department of War health benefits. The Department of Health and Human Services (HHS), Centers for Medicare & Medicaid Services (CMS) has issued a notice in the Federal Register regarding the...

Sources

Health and Human Services Department, Centers for Medicare & Medicaid Services · Privacy Act of 1974; Matching Program · Aug 5
Notable HHS 💬 Comments close in 43 days (Sep 28)

AHRQ Seeks OMB Extension for CAHPS Database Collection with Proposed Changes

AHRQ requests OMB approval to continue collecting CAHPS survey data from health plans, proposing modifications to the existing information collection for quality measurement. The Agency for Healthcare Research and Quality (AHRQ) has announced its intention to request Office of Management and...

Sources

Health and Human Services Department, Agency for Healthcare Research and Quality · Agency Information Collection Activities: Proposed Collection; Comment Request · Jul 30
Notable HHS 💬 Open for industry feedback

NIDA proposes updates to data use certification for NIH Brain Development Cohorts Data Hub

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...

Sources

Health and Human Services Department, National Institutes of Health · Proposed Collection; 60-Day Comment Request, Data Use Certification for the NIH Brain Development Cohorts (NBDC) Data Hub, (National Institute on Drug Abuse) · Jul 31

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