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Rules in motion

273 healthcare rules, from first draft to the day they bite. Tell us who you are to see what each one means for you.

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Calendar Year 2027 Home Health Prospective Payment System (HH PPS) proposed rule CMS · Proposed

Fourth Temporary Extension of COVID-19 Telemedicine Flexibilities for Prescription of Controlled Substances DEA · Effective · Expires Dec 31, 2026

Temporary Placement of 7-hydroxymitragynine Above a Specified Threshold in Schedule I HHS · Proposed

Contract Year 2027 Medicare Advantage and Part D Rate Announcement CMS · Final

2023 RADV Audit Rule (Medicare Advantage risk adjustment data validation) CMS · Litigated

CY 2027 Hospital OPPS/ASC proposed rule CMS · Proposed · Botulinum prior auth effective Jul 1, 2027

ACCESS Model CMS · Effective

Tax Exempt Hospital Transparency Act (H.R. 9504) Congress · Proposed

State pharmacy benefit manager laws (Virginia S.B. 669, California licensing, Ohio H.B. 229) State agency · Effective · California license deadline Jan 1, 2027

Medicaid Community Engagement Requirement interim final rule CMS · Litigated · Work requirement starts Jan 1, 2027

Nurse Practitioner Modernization Act independent-practice provision (sunset) State agency · Effective

Medicare Program; Strengthening Oversight of Accrediting Organizations CMS · Final · Effective Jun 16, 2027

Medicare Advantage 2026 star ratings methodology CMS · Litigated

Missouri Senate Bill 751 (340B contract-pharmacy law) State agency · Litigated

CMS-2449-P: Medicaid Managed Care State Directed Payments and Medicaid Fee-for-Service Targeted Medicaid Practitioner Payments CMS · Proposed

Medicaid 80-hour-a-month community-engagement (work) requirement State agency · Effective · All states deadline Jan 1, 2027

CY 2027 Home Health Prospective Payment System proposed rule (CMS-1844-P) CMS · Proposed

Calendar Year 2027 Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) proposed rule CMS · Proposed

Temporary Placement of 7-Hydroxymitragynine Above a Specified Threshold in Schedule I DEA · Proposed

Nondiscrimination on the Basis of Disability final rule, Section 504 accessible medical equipment requirement HHS-OCR · Effective

Calendar Year 2027 Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Proposed Rule CMS · Proposed

Marijuana rescheduling from Schedule I to Schedule III DEA · Litigated

Medicaid work requirement interim final rule (medically frail exemption) CMS · Litigated

Ambulatory Specialty Model (ASM) for heart failure CMS · Final · Launch Jan 1, 2027

Medicaid Managed Care State Directed Payments and Medicaid Fee-for-Service Targeted Medicaid Practitioner Payments (CMS-2449-P) CMS · Proposed · Phase down start Jan 1, 2028

Calendar Year 2027 Hospital OPPS/ASC Proposed Rule CMS · Proposed

Transcatheter Aortic Valve Replacement (TAVR) National Coverage Determination (CAG-00430R2) CMS · Proposed

CY2027 Hospital OPPS/ASC Rule (Site-Neutral Imaging Payment Cut) CMS · Proposed

Missouri health care bill package (HB 2372, HB 2974, SB 878, SB 999, SB 1019, SB 1233) State agency · Final

Change in Eligibility Period for Refugee Cash Assistance and Refugee Medical Assistance HHS · Effective

Patients First Act of 2026 with ROOT Act (S. 5672) Congress · Proposed

Calendar Year 2027 Physician Fee Schedule Proposed Rule (CMS-1848-P) CMS · Proposed · Aco part b waiver start Apr 1, 2027

Psychedelic Drugs: Considerations for Clinical Investigations; final guidance and Request for Information on care delivery models FDA · Final

Senate Bill 3025 (Act 220), Medical Debt Acquisition and Forgiveness Program State agency · Effective

Designated Placement Requirements Under Titles IV-E and IV-B for LGBTQI+ Children; Rescission HHS · Final

Advisory Opinion 26-16, Food as Medicine Program HHS-OIG · Final

FY2027 IPPS Rule (TEAM Spinal Fusion Expansion) CMS · Proposed

Clinical Laboratory Improvement Amendments (CLIA) regulations Request for Information CMS · Proposed

Improving Seniors' Timely Access to Care Act of 2025 (H.R. 3514) Congress · Proposed

Risk-Based Survey Process for Nursing Homes (QSO-26-14-NH) CMS · Final

CY2027 Medicare Physician Fee Schedule Rule (MIPS Sunset and Value Pathways) CMS · Proposed

CY2027 Hospital Outpatient Prospective Payment System proposed rule, EMTALA accreditor deeming provision CMS · Proposed

Acute Hospital Care at Home waiver extension, Consolidated Appropriations Act of 2026 CMS · Effective · Effective Sep 30, 2030

340B Rebate Model Pilot Program HRSA · Final · Pilot launch Jan 1, 2027

Title X family planning grant screening rules HHS · Litigated

PBM Compensation Reform (CAA 2026 Part D Delinking, DOL Fee Disclosure Rule, FTC Express Scripts Settlement) DOL / Treasury · Proposed

2027 Notice of Benefit and Payment Parameters final rule CMS · Litigated

503B Bulks List exclusion of semaglutide, tirzepatide, and liraglutide FDA · Proposed

CY 2027 Medicare Physician Fee Schedule Proposed Rule (CMS-1848-P) CMS · Proposed

State Private Equity Health Care Transaction Review Laws (California AB-1415, Rhode Island, Maine) State agency · Effective · Maine effective Jan 1, 2027

Medicare Drug Price Negotiation Program manufacturer effectuation guidance CMS · Proposed · Effective Jan 1, 2028

CY2027 Physician Fee Schedule Proposed Rule, G2211 Modifier and RPM/RTM Staffing Provisions CMS · Proposed

CY2027 Physician Fee Schedule Proposed Rule, MSSP Benchmark Provisions CMS · Proposed

DOJ 2011 Olmstead integration mandate enforcement guidance DOJ · Effective

CMS-ICE Medicaid data sharing agreement CMS · Litigated

New York Nurse Practitioner Independent Practice Authority Extension State agency · Effective · New sunset Jul 1, 2030

INSULIN Act of 2026 Congress · Proposed

Medicare Advantage Medical Loss Ratio Transparency Act Congress · Proposed · Effective Jan 1, 2029

National Coverage Determination reconsideration for Transcatheter Aortic Valve Replacement (TAVR) CMS · Proposed

CY2027 Hospital OPPS/ASC Proposed Rule (CMS-1850-P): 340B drug payment reduction CMS · Proposed · Effective Jan 1, 2027

2027 Notice of Benefit and Payment Parameters CMS · Litigated

2027 Medicare Physician Fee Schedule CMS · Proposed · Effective Jan 1, 2027

CY 2027 Physician Fee Schedule proposed rule CMS · Proposed

Mental Health Parity and Addiction Equity Act Enforcement - Field Assistance Bulletin 2026-03 DOL / Treasury · Litigated

Medicaid Program; Amending the Indirect Hold Harmless Threshold of Health Care-Related Taxes CMS · Proposed · Effective Oct 1, 2027

Nationwide Medicare enrollment moratoria for new hospices and home health agencies CMS · Effective · Expiration Nov 13, 2026

Hospice FY2027 Annual Payment Update HOPE Compliance Requirement CMS · Effective · Telecom gcode effective Jan 1, 2027

Section 340B rebate model HHS approval requirement HRSA · Litigated

Pennsylvania 2027 ACA Marketplace Rate Filings State agency · Proposed

CY2027 Hospital Outpatient Prospective Payment System and ASC Payment System Proposed Rule CMS · Proposed · Ipo list full elimination target Jan 1, 2029

Rescission of Title VI disparate-impact provisions, 45 CFR Part 80 HHS · Effective

Renewal of NCQA deeming authority for Medicare Advantage HMOs and PPOs CMS · Final

Medicaid community engagement (work) requirement interim final rule CMS · Effective · Compliance start Jan 1, 2027

2027 Notice of Benefit and Payment Parameters final rule CMS · Litigated

CY 2027 ESRD Prospective Payment System final rule CMS · Final · Low volume attestation Dec 31, 2026

Increasing Organ Transplant Access (IOTA) Model, Performance Year 2 transplant incentive increase CMS · Effective

Kidney Care Choices (KCC) Model Payment Updates, PY2026 CMS · Effective · Extension through Dec 31, 2027

Software as a Medical Service (SaMS) payment category, CY2027 Hospital OPPS rule CMS · Proposed

CY2027 Medicare Physician Fee Schedule Proposed Rule CMS · Proposed

Part D Premium Stabilization Demonstration CMS · Final · Demonstration ends Dec 31, 2026

Cancer Clinical Trial Eligibility Criteria guidances (laboratory values, washout periods and concomitant medications, and performance status) FDA · Final

CY 2027 Medicare Physician Fee Schedule proposed rule (CMS-1848-P) CMS · Proposed · Effective Jan 1, 2027

Fiscal Year 2027 Skilled Nursing Facility Prospective Payment System Final Rule (CMS-1843-F) CMS · Final

Wisconsin Medicaid postpartum coverage extension (60 days to 12 months) State agency · Effective

Fiscal Year 2027 Hospice Wage Index and Payment Rate Update and Hospice Quality Reporting Program Requirements Final Rule (CMS-1851-F) CMS · Final

FY2027 Inpatient Psychiatric Facility (IPF) Prospective Payment System Final Rule CMS · Final

Fiscal Year 2027 Skilled Nursing Facility Prospective Payment System Final Rule (CMS-1843-F) CMS · Final

CY2027 Hospital Outpatient Prospective Payment System proposed rule: Emergency Care Access and Timeliness (ECAT) eCQM CMS · Proposed

Proposed exclusion of semaglutide, tirzepatide, and liraglutide from the section 503B Bulks List FDA · Proposed

2027 Notice of Benefit and Payment Parameters final rule CMS · Litigated

FY2027 Hospice Wage Index and Payment Rate final rule (CMS-1851-F) CMS · Final

FY2027 IPPS/LTCH Prospective Payment System final rule (CMS-1849-F), including CJR-X CMS · Final · Cjr x start Jan 1, 2028

Medicare Program; Inpatient Rehabilitation Facility Prospective Payment System for Federal Fiscal Year 2027 (CMS-1845-F) CMS · Final

LEAD Model (Long-Term Enhanced ACO Design) CMS · Final · Launch Jan 1, 2027

CY2027 Medicare Physician Fee Schedule proposed rule CMS · Proposed

CY2027 MPFS same-day E/M reduction and remote monitoring consolidation CMS · Proposed

CJR-X mandatory joint replacement bundle CMS · Final · Effective Jan 1, 2028

Rural Health Care Program rate-justification waiver and Third Further Notice of Proposed Rulemaking Federal Communications… · Final

TAVR National Coverage Determination proposed decision memo CMS · Proposed

State Medicaid and CHIP Applied Behavior Analysis Toolkit CMS · Effective

Calendar Year 2027 Medicare Physician Fee Schedule proposed rule (CMS-1848-P) CMS · Proposed · Launch Jan 1, 2027

Federal Independent Dispute Resolution Operations Final Rule DOL / Treasury · Effective

CY2027 Hospital Outpatient Prospective Payment System and Ambulatory Surgical Center Payment Rule CMS · Proposed · Effective Jan 1, 2027

FY 2027 Hospital Inpatient Prospective Payment System and Long-Term Care Hospital Rule (CMS-1849-F), including the CJR-X mandatory bundle CMS · Final · Cjrx launch Jan 1, 2028

Temporary Placement of 7-Hydroxymitragynine and Mitragynine Pseudoindoxyl in Schedule I DEA · Proposed · Order earliest publication Nov 13, 2026

FY2027 Hospice Wage Index and Payment Rate Update (CMS-1851-F) CMS · Final

Medical Assistance Protection Act State AG · Effective

STOP FRAUD in Medicaid Act (H.R. 5364 / S. 4176) Congress · Proposed

Transforming Episode Accountability Model (TEAM) updates in the FY2027 Hospital IPPS Final Rule CMS · Final · Downside risk start Jan 1, 2027

Continuing resolution (H.R. 6500) funding the federal government through December 11, 2026 Congress · Proposed · Hemp thc ban delay Nov 12, 2026

Regulatory Alignment for Predictable and Immediate Device (RAPID) coverage pathway CMS · Proposed

Radiology Devices; Reclassification of Digital Breast Tomosynthesis System FDA · Proposed

Regulatory Alignment for Predictable and Immediate Device (RAPID) Coverage Pathway (CMS-3487-NC) CMS · Proposed

Substances Generally Recognized as Safe (GRAS) mandatory notification rule FDA · Comment open · Comment close Dec 9, 2026

Section 1135 Waivers for Washington Wildfire Public Health Emergency CMS · Effective

Prohibition on Federal Medicaid and CHIP Funding for Sex-Rejecting Procedures Furnished to Children CMS · Litigated · Hormone grace period ends Apr 13, 2027

HB 26-1195, AI Therapy Services State agency · Effective

Delivering Gold Standard Childhood Vaccine Recommendations for Americans CDC · Effective

CY2027 Medicare Physician Fee Schedule proposed rule (CMS-1848-P), dual obstetric billing codes CMS · Proposed

No Surprises Act qualifying payment amount calculation rule (2021 interim final rule) HHS · Litigated

Medicaid managed care state directed payments cap (CMS-2449-P) CMS · Proposed

Reclassification of In Situ Hybridization Test Systems for Use With a Corresponding Approved Oncology Therapeutic Product FDA · Final

Medicaid demonstration budget neutrality policy (SMD 26-003) CMS · Effective · Waiver expires Dec 31, 2026

RAPID Coverage Pathway (CMS-3487-NC) CMS · Proposed

Proposed rescheduling of dual orexin receptor antagonists to Schedule V DEA · Proposed

SUSTAIN 340B Act Congress · Proposed

Medicare Drug Price Negotiation Program and Medicare Prescription Drug Benefit Program integrity rule (CMS-4215-P) CMS · Proposed · Next selection deadline Feb 1, 2027

FEHB/PSHB gender-affirming care coverage exclusion directive OPM · Litigated

National Fraud Enforcement Division DOJ · Final

Emergency organ donor serology testing window (HIV and West Nile virus) OPTN · Effective

Prohibition on Federal Medicaid and Children's Health Insurance Program Funding for Sex-Rejecting Procedures Furnished to Children CMS · Final

Temporary Placement of O-Desmethyltramadol (O-DSMT) in Schedule I DEA · Effective · Expires Aug 12, 2028

No Surprises Act qualifying payment amount (QPA) formula DOL / Treasury · Litigated

Nurses for Nursing Homes Program (NNHP) System of Records Notice CMS · Proposed

Categories Used in Federal Vaccine Recommendations and the Role of Shared Clinical Decision-Making RFI HHS · Proposed

CY2027 Medicare Physician Fee Schedule: RPM/RTM outsourced staffing ban CMS · Proposed

Medicare Drug Price Negotiation Program (Inflation Reduction Act) CMS · Litigated

2027 Oregon health insurance rate approvals State agency · Final

CY2027 Medicare Physician Fee Schedule obstetric billing G-codes CMS · Proposed · Effective Jan 1, 2027

2027 Connecticut individual and small-group health insurance rate filings State agency · Proposed

NEISS-R hospital emergency department data collection program Consumer Product Safet… · Effective

CY2027 Medicare Physician Fee Schedule Proposed Rule (CMS-1848-P) CMS · Proposed

Medicare Drug Price Negotiation Program (Inflation Reduction Act) CMS · Litigated

LEAD Model (ACO REACH successor) CMS · Final · Performance year 1 start Jan 1, 2027

Medicare Advantage RADV audit extrapolation rule CMS · Litigated

Calendar Year 2027 Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Proposed Rule CMS · Proposed

CY 2027 Home Health Prospective Payment System Rate Update and Program Integrity Provisions CMS · Proposed

Most Favored Nation (MFN) drug pricing agreements The White House · Effective

Rhode Island 2027 Individual Market Health Insurance Rate Filings State agency · Proposed

Title X Family Planning Grant Conditions (HHS 2026) HHS · Litigated · Compliance deadline Apr 1, 2027

Regulation for Federal Financial Assistance (Uniform Guidance rewrite) Office of Management a… · Proposed · Cr funding through Dec 11, 2026

Local Coverage Determination for Trigger Point Injections (L33912, L35010) CMS · Effective

Most-Favored-Nation Drug Pricing Agreements HHS · Effective

UnitedHealthcare removal of prior authorization for 1,700 procedure codes UnitedHealthcare · Effective

Counseling Compact Counseling Compact Com… · Effective

False Claims Act qui tam whistleblower provision (Appointments Clause challenge) Court · Litigated

Colorado 340B contract pharmacy access law State agency · Litigated

Temporary Placement of Mitragynine Pseudoindoxyl, MGM-15, and MGM-16 in Schedule I DEA · Effective

CY 2027 Hospital Outpatient Prospective Payment System and Ambulatory Surgical Center Payment Systems CMS · Proposed

Wasteful and Inappropriate Service Reduction (WISeR) Model CMS · Effective · End date Dec 31, 2031

2027 ACA Marketplace Rate Approvals State agency · Final · Open enrollment Nov 1, 2026

Texas Medicaid Directed Payment Programs (including CHIRP) CMS · Proposed

APRN Modernization Act State agency · Effective

Calendar Year 2027 Medicare Physician Fee Schedule CMS · Proposed

Doctors Not AI Act (H.R. 10210) Congress · Proposed

Compounding of Starter Parenteral Nutrition for Neonates (temporary enforcement priorities guidance) FDA · Effective

Illinois End-of-Life Options for Terminally Ill Patients Act (EOLA) State agency · Litigated

CDC Childhood Vaccine Schedule Revision (January 2026) CDC · Litigated

CY 2027 Medicare Physician Fee Schedule Proposed Rule CMS · Proposed

FDA mifepristone mail-order and telehealth prescribing authorization (2023) FDA · Litigated

2027 Medicare Advantage Star Ratings Cutpoints CMS · Proposed

Calendar Year 2027 Medicare Physician Fee Schedule Proposed Rule CMS · Proposed · Effective Jan 1, 2027

Medicaid Targeted Supplemental Payment Cap for Ground Emergency Medical Transport CMS · Proposed · Effective Jan 1, 2029

Indiana House Enrolled Act 1271 - Payment of Health Claims State agency · Effective

Oregon Senate Bill 951 - Corporate Practice of Medicine State agency · Effective

Washington 2027 Individual Market Rate Filing Approval State agency · Final

2027 Current Procedural Terminology (CPT) Code Set American Medical Assoc… · Final · Effective Jan 1, 2027

Cardiovascular Machine Learning-Based Notification Software Classification (Class II) FDA · Final

GLP-1 Bridge Demonstration CMS · Effective · End Dec 31, 2027

Medicare Part D Reasonable and Relevant Pharmacy Contracting Standards CMS · Comment open · Comment close Nov 23, 2026

2027 Health Insurance Rate Filings, Pennsylvania Individual and Small Group Markets State agency · Proposed · Open enrollment Nov 1, 2026

CY 2027 Medicare Physician Fee Schedule Proposed Rule CMS · Proposed · Effective Jan 1, 2027

One Big Beautiful Bill Act Section 71109 - Medicaid Noncitizen Eligibility Narrowing CMS · Effective

ACCESS (Advancing Chronic Care with Effective, Scalable Solutions) Innovation Center Model Expansion CMS · Final · Tracks open Apr 1, 2027

Preventive Health Savings Act Congress · Proposed

Johnson and Johnson 340B Covered Entity Claims Data Reporting Policy Johnson and Johnson · Effective · Effective federal grantees Nov 3, 2026

Apples to Apples Comparison Act of 2025 House Committee on Way… · Proposed

Amending the Indirect Hold Harmless Threshold of Health Care-Related Taxes CMS · Proposed · Phasedown starts Oct 1, 2027

GENEROUS Model (GENErating cost Reductions fOr U.S. Medicaid) CMS · Effective

2027 ACA Individual and Small-Group Rate Decisions State agency · Final

Medicaid Work Requirements Interim Final Rule (Medical Frailty Exemption) CMS · Litigated

CY2027 Medicare Physician Fee Schedule Proposed Rule CMS · Proposed · Effective Jan 1, 2027

Ambulatory Specialty Model (ASM) CMS · Final · Effective Jan 1, 2027

Justice Manual Revisions JM 1-19.000 and JM 4-4.111 (Brand Memo Revival) DOJ · Final

2026 Medicare Advantage Star Ratings Recalculation CMS · Litigated

National Coverage Determination for Transcatheter Aortic Valve Replacement CMS · Final

Medicare National Coverage Determination for Transcatheter Aortic Valve Replacement CMS · Final

CY2027 Medicare Clinical Laboratory Fee Schedule CMS · Proposed · Effective Jan 1, 2027

ACA Marketplace Anti-Fraud Interim Final Rule 2026 CMS · Effective

Ryan White HIV/AIDS Program Gender-Affirming Care Funding Conditions 2026 HRSA · Litigated

Medicare Part D Reasonable and Relevant Pharmacy Contracting Standards CMS · Comment open · Comment close Nov 23, 2026

Investing in Health Outcomes Medicaid Quality Initiative CMS · Effective

Merck 340B Program Integrity Initiative Contract Pharmacy Restriction Merck · Effective

HHS Section 504 Community Integration Provisions (2024 Final Rule) HHS · Litigated

Long-Term Enhanced ACO Design (LEAD) Model CMS · Final · Implementation period end Dec 31, 2026

CY 2027 Physician Fee Schedule Proposed Rule, Remote Monitoring Direct-Employment Requirement CMS · Proposed · Effective Jan 1, 2027

Calendar Year 2027 Medicare Physician Fee Schedule CMS · Proposed

Medicare Advantage Star Ratings Methodology CMS · Litigated · Final replies due Nov 18, 2026

Calendar Year 2027 Medicare Physician Fee Schedule Final Rule CMS · Final · Statutory deadline Nov 1, 2026

Medicaid work requirements medically frail definition (Massachusetts v. Oz) CMS · Litigated · Effective Jan 1, 2027

Medicaid Program; Amending the Indirect Hold Harmless Threshold of Health Care-Related Taxes CMS · Comment open

ACGME proposal to delete emergency medicine-specific resident hour and faculty ratio requirements Accreditation Council … · Proposed

Clinical Laboratory Improvement Amendments Virtual Access, Gynecologic Cytology Proficiency Testing, and Personnel Qualifications Proposed Rule CMS · Comment open · Comment close Dec 7, 2026

Hospital Readmissions Reduction Program FY2027 CMS · Effective

2025 Reconciliation Law Medicaid and CHIP Non-Citizen Eligibility Restrictions CMS · Effective

Lower Premiums, Faster Payments Act Congress · Proposed · Effective Nov 13, 2026

Medicaid Section 1115 Reentry Demonstrations CMS · Effective · Expiration Sep 30, 2031

Section 232 Pharmaceutical Import Tariffs White House · Effective · Hhs pricing deal zero through Jan 20, 2029

Tennessee PBM and Insurer Pharmacy Ownership Ban State agency · Litigated · Effective Jul 1, 2028

HHS 340B rebate pilot HHS · Litigated

Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products: Questions and Answers FDA · Final

Requirements for Additional Traceability Records for Certain Foods: Enforcement Policy for Certain Retail Food Establishments and Restaurants FDA · Comment open · Comment close Nov 23, 2026

FDA Request for Information: Early-Stage Human Trials of Ibogaine FDA · Comment open · Comment close Nov 20, 2026

Standards of Identity Salt Substitutes Final Rule FDA · Final · Dairy objections due Nov 12, 2026

Transparency in Coverage Final Rule CMS · Final · Effective Dec 7, 2026

2027 Medicare Advantage star ratings methodology CMS · Litigated

Classification of System for Detection of Nucleic Acid From Non-Viral Microorganisms Causing Sexually Transmitted Infections FDA · Final

Classification of Infant Pulse Rate and Oxygen Saturation Monitor for Over-the-Counter Use FDA · Final

2027 Supplement to the Physical Activity Guidelines for Americans HHS · Comment open · Comment close Nov 12, 2026

Ambulatory Specialty Model Heart-Failure Track Final Participant List CMS · Final · Start Jan 1, 2027

CY 2027 Medicare Physician Fee Schedule (proposed rule) CMS · Proposed

Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products: Questions and Answers FDA · Final

Use of Salt Substitutes To Reduce the Sodium Content in Standardized Foods FDA · Final · Dairy objections due Nov 12, 2026

FY2027 Hospital Inpatient Prospective Payment System Final Rule CMS · Effective

HHS Statement of Delegation of Authority - Section 1128(b) Permissive Exclusions to CMS Administrator HHS · Effective

Counseling Compact Counseling Compact Com… · Effective

Calendar Year 2027 Hospital Outpatient Prospective Payment System Proposed Rule CMS · Proposed

Premium Tax Credit DOL / Treasury · Comment open · Comment close Nov 30, 2026

2027 Medicare Advantage Star Ratings CMS · Litigated

CDC Order Continuing Suspension of Entry from Countries with Quarantinable Disease CDC · Effective · Expires Nov 10, 2026

CMS Hurricane Isaias Emergency Flexibilities for Florida and Alabama CMS · Effective

CY2027 Hospital Outpatient Prospective Payment System and Ambulatory Surgical Center Payment Rule CMS · Proposed

Part D PBM compensation proposed rule (CAA 2026 sections 6219, 6220, 6224) CMS · Comment open · Comment close Dec 15, 2026

DOJ and HHS-OIG coordinated health care fraud self-disclosure policy DOJ + HHS · Effective

FY2027 IRF PPS interdisciplinary team meeting timing enforcement discretion CMS · Final · Discretion end Mar 31, 2027

Regulatory Considerations for Prescription Drug Use-Related Software (final guidance) FDA · Final

HHS civil monetary penalty inflation adjustment for 2026 (no adjustment) HHS · Final

CY 2027 Medicare Physician Fee Schedule CMS · Proposed

CMS Interoperability and Prior Authorization Final Rule CMS · Final · Effective Jan 1, 2027

Executive Order 14437: Advancing Women's Health to Improve Outcomes in All Phases of Life HHS · Final

Action Levels for Cadmium in Processed Food Intended for Babies and Young Children (draft guidance) FDA · Comment open · Comment close Dec 22, 2026

Questions and Answers Regarding Mandatory Cosmetics Recalls (final guidance) FDA · Final

No Surprises Act QPA enforcement discretion (FAQ Part 73) CMS · Effective

Patient Protection and Affordable Care Act: Exchange Pre-Eligibility Verification CMS · Comment open · Comment close Nov 27, 2026

Improving Transparency into Pharmacy Benefit Manager Fee Disclosure Employee Benefits Secu… · Final · Published Nov 2, 2026

Healthcare False Claims Act Self-Disclosure Pilot Program DOJ + HHS · Effective · Comment close Apr 22, 2027

Ambulatory Specialty Model exceptions and updates (CY2027 PFS proposal) CMS · Proposed · Effective Jan 1, 2027

CY2027 Medicare Physician Fee Schedule proposed rule CMS · Proposed

Transcatheter Aortic Valve Replacement (TAVR) for Aortic Regurgitation (AR) CMS · Proposed · Proposed decision Mar 10, 2027

Requirement for Attestation for All Airline or Other Aircraft Passengers Arriving in the United States CDC · Final · Effective Nov 3, 2026

Calendar Year 2027 Outpatient Prospective Payment System rule CMS · Proposed

Medicare Drug Price Negotiation third cycle and 2028 effectuation draft guidance CMS · Proposed · Effective Jan 1, 2028

Health Data, Technology, and Interoperability: ONC Deregulatory Actions to Unleash Prosperity (HTI-5) ONC · Final

DEA special registration for telemedicine prescribing of controlled substances DEA · Proposed · Flexibilities expire Dec 31, 2026

Calendar Year 2027 Home Health Prospective Payment System Rate Update CMS · Proposed · Effective Jan 1, 2027

Enforcement discretion policy for 503A compounding of certain peptide bulk drug substances HHS · Comment open · Comment close Nov 13, 2026

Organ Procurement Organizations Conditions for Coverage final rule CMS · Final

Placement of centanafadine in Schedule III DEA · Effective · Comment close Nov 30, 2026

Drug Efficacy Study Implementation 7661 estrogen-androgen fixed-combination drugs FDA · Final · Effective May 4, 2027

Essential Drug Delivery Performance Characteristics for Devices Intended to Deliver Drugs and Biologics FDA · Comment open · Comment close Jan 28, 2027

Infant Formula Nutrient Requirements FDA · Comment open · Published Nov 2, 2026