Before heading out for the holidays, the Department of Health and Human Services (HHS) released their 2024 regulatory agenda. HHS included 177 rules currently in the various stages of rulemaking: Prerule Stage, Proposed Rule Stage and the Final Rule Stage. Below are just some of the rules we are watching with their expected due dates – please note, these dates may change.

HHS has committed to releasing proposed payment rules in line with their required statutory deadlines:

Expected April ’24

• FY 2025 Hospital Inpatient Prospective Payment Systems (IPPS) for Acute Care Hospitals; the Long-Term Care Hospital Prospective Payment System
• Episode-Based Payment Model
• FY 2025 Hospice Wage Index, Payment Rate Update, and Quality Reporting Requirements
• FY 2025 Skilled Nursing Facility (SNFs) Prospective Payment System and Updates to the Value-Based Purchasing and Quality Reporting Programs
• FY 2025 Inpatient Rehabilitation Facility (IRF) Prospective Payment System Rate Update and Quality Reporting Program
• FY 2025 Inpatient Psychiatric Facilities Prospective Payment System Rate and Quality Reporting Updates

Expected June ’24

• CY 2025 Hospital Outpatient Prospective Payment System (OPPS) Policy Changes and Payment Rates and Ambulatory Surgical Center (ASC) Payment System Policy Changes
• CY 2025 Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Medicare Part B
• Medicare Advantage and Medicare Prescription Drug Benefit Program Payment Policy
• CY 2025 Changes to the End-Stage Renal Disease (ESRD) Prospective Payment System and Quality Incentive Program
• CY 2025 Home Health Prospective Payment System Rate Update and Home Infusion Therapy and Home IVIG Services Payment Update

Expected December ’24

• Federal Independent Dispute Resolution Process Fees (Final Rule)

The Department is also working on rules addressing the Social Determinants of Health…

Tobacco Cessation

• Tobacco Product Standard for Nicotine Level of Certain Tobacco Products
  (Proposed Rule; April ’24)
• Prohibition of Sale of Tobacco Products to Persons Younger Than 21 Years of Age
  (Final Rule; April ’24)

Access to Care

• Medications for the Treatment of Opioid Use Disorder (Final Rule; January ’24)
• Streamlining the Medicaid, CHIP, and BHP Application, Eligibility Determination, Enrollment, and Renewal Processes (Final Rule; February ’24)
• Amendments to Rules Governing Organ Procurement Organizations (Proposed Rule; February ’24)
• Rulemaking on Discrimination on the Basis of Disability in Health and Human Services Programs or Activities (Proposed Rule; April ’24)
• Ensuring Access to Medicaid Services (Final Rule; April ’24)
• Provider Nondiscrimination Requirements for Group Health Plans and Health Insurance Issuers in the Group and Individual Markets (Proposed Rule; August ’24)
• Coverage of Certain Preventive Services Under the ACA (Final Rule; August ’24)

… and Health Information Technology.

• Establishment of Disincentives for Health Care Providers Who Have Committed Information Blocking (Proposed Rule; January ’24)
• Standards for Data Exchange (Proposed Rule; May ’24)
• Proposed Modifications to the HIPAA Security Rule to Strengthen the Cybersecurity of Electronic Protected Health Information (Proposed Rule; September ’24)

HHS also has a few promised regulations left over from 2023. The Department still plans to release proposed rules on:

• Health Data, Technology, and Interoperability: Patient Engagement, Information Sharing, and Public Health Interoperability
• Healthcare System Resiliency and Modernization
• Alternative Payment Model: Increasing Organ Transplant Access (IOTA) Model
• Mental Health Parity and Addiction Equity Act and the Consolidated Appropriations Act, 2021