Health Care Policy Update – Weekly Wrap-up and What’s Ahead – July 1, 2024


When is Congress in session? House 2024 Calendar Senate 2024 Calendar

What’s Ahead: This Week

Hearings and Markups – No notable hearings this week. Congress is not in session.

Notable Policy Events – No notable policy events for this week.

Weekly Wrap: Notable Health Care Developments from Last Week

Medicare & Medicaid 

  • On June 24, CMS announced that the District of Columbia submitted a request to renew its section 1115 demonstration waiver to continue to use Medicaid funding to reimburse institutions for mental diseases for treatment provided to Medicaid-eligible adults with substance use disorders and serious mental illness and expand services for justice involved individuals. The federal public comment period is open through July 24, 2024. Pending Application Submit comments
  • On June 25, CMS announced the 18 states that were recipients of the implementation, enhancement, and expansion of Medicaid and CHIP School-Based Services grants. Bulletin List of States
  • Also on June 25, the HHS Office of Inspector General (OIG) published a report finding that on North Carolina did not report and return all Medicaid overpayments for the state’s Medicaid Fraud Control Unit. Full Report Report in Brief
  • Also on June 25, Sen. Blackburn (R-TN) led 14 bipartisan Senators in a letter urging CMS to make reimbursement changes for Positron Emission Tomography (PET) and Single Photon Emission Computed Tomography (SPECT) in the calendar year 2025 Outpatient Prospective Payment System rule. Letter Press Release
  • On June 26, 2024, CMS issued the Calendar Year (CY) 2025 Home Health Prospective Payment System (HH PPS) proposed rule, which would update Medicare payment policies and rates for Home Health Agencies (HHAs). Comments are due August 26, 2024. Fact Sheet Proposed Rule
  • On June 27, CMS announced that New York submitted a request to amend its section 1115 demonstration to provide continuous eligibility to children up until age six who are enrolled in Medicaid and CHIP. The federal public comment period is open through July 26, 2024. Pending Application Submit Comments
  • Also on June 27, HHS OIG released findings from an audit of one Medicare Advantage organization. OIG found that most of the selected diagnosis codes submitted to CMS for use in CMS’s risk adjustment program did not comply with Federal requirements. Full Report Report in Brief
  • Also on June 27, CMS issued a proposed rule to update payment rates and policies under the End-Stage Renal Disease (ESRD) Prospective Payment System (PPS). Comments are due August 26, 2024. Fact Sheet Proposed Rule
  • On June 28, CMS released the latest enrollment figures for Medicare, Medicaid, and CHIP. As of March 2024, 67,178,618 people are enrolled in Medicare and 82,751,338 people are enrolled in Medicaid and CHIP. Enrollment Data

Marketplaces – On June 24, the Congressional Budget Office (CBO) released a report finding that permanently extending the ACA expanded premium tax credit would cost $383 billion over the next 10 years The report was requested by House Ways & Means Committee Chair Smith (R-MO) and House Budget Committee Chair Arrington (R-TX). CBO Press Release Report Ways & Means Committee Press Release

Payment & Delivery System Models – 

  • On June 26, CMS released the notice of funding opportunity (NOFO) application for the Transforming Maternal Health (TMaH) Model, which aims to improve health outcomes for mothers and their infants who are enrolled in Medicaid and CHIP. CMS will award up to 15 state Medicaid agencies with a maximum of $17 million to implement the model, which is set to run from January 20, 2025 – January 19, 2035. FAQs Model Fact Sheet TMaH Model
  • On June 28, CMS announced the release of the State Request for Applications (RFA) for the Cell and Gene Therapy (CGT) Access Model. Applications are due February 28, 2025. CGT Access Model State RFA
  • Also on June 28, CMS released a proposed rule that would address anomalous and billing activity for selected intermittent urinary catheters on Medicare Durable Medical Equipment, Prosthetics, Orthotics & Supplies (DMEPOS) claims for Medicare Shared Savings Program (MSSP) accountable care organizations (ACOs). Comments are due July 29, 2024. Proposed Rule Fact Sheet
  • Also on June 28, HHS OIG released findings from a study of the extent to which formularies used by Medicare Part D plans include drugs commonly used by full benefit dual eligible enrollees. Full Report

Health IT, Privacy, & Digital Health – 

  • On June 24, HHS issued a final rule that establishes disincentives for health care providers that have committed information blocking, practices that the health care providers knew were unreasonable and were likely to interfere with, prevent, or materially discourage the access, exchange, or use of electronic health information (EHI), except as required by law or covered by a regulatory exception. Final Rule Press Release
  • On June 25, Rep. Nadler (D-NY) and Sen. Warren (D-MA) led 45 Representatives and four Senators in a bicameral, bipartisan letter to CMS urging oversight of artificial intelligence (AI) used in Medicare Advantage coverage decisions. Letter Press Release

Mental Health and Substance Use Disorder Policy – On June 24, the U.S. Department of Veterans Affairs announced $10 million in new funding for eligible states, territories, and Tribal governments through cooperative agreements to better inform Veteran suicide prevention strategies. Notice of Funding Press Release

Prescription Drugs & Health Innovation – 

  • On June 24, Senate Finance Committee Chair Wyden (D-OR) sent a letter to CMS asking the agency to increase enforcement and oversight of pharmacy benefit managers (PBMs) in Medicare Part D. Letter Press Release
  • On June 25, the FDA issued a Small Entity Compliance Guide to help small entities comply with FDA regulations pertaining to in vitro diagnostic (IVD) products. Small Entity Compliance Guide
  • On June 26, HHS announced some Medicare enrollees will pay less for 64 drugs available through Medicare Part B under the Inflation Reduction Act. Press Release
  • On June 27, Sen. Warren (D-MA) and Rep. Carter (R-GA) led 20 Representatives and two Senators in a bicameral, bipartisan letter to the Department of Defense (DOD) raising concerns over an exclusive contract to administer TRICARE’s pharmacy program. Letter Press Release

SDOH & Health Equity –

  • On June 26, the FDA issued draft guidance to increase the enrollment of participants from underrepresented populations in clinical studies. Comments are due September 26, 2024. Draft Guidance Press Release
  • On June 27, Sens. Wyden (D-OR) and Merkley (D-OR) sent a letter to the Office of the National Coordinator for Health Information Technology (ONC) supporting the HHS proposal to make data collection on sexual orientation and gender identity more inclusive in electronic health records. Letter Press Release

Misc. – On June 27, the Department of Justice (DOJ) announced the 2024 National Health Care Fraud Enforcement Action, which charged 193 defendants for alleged health care fraud schemes involving over $2.75 billion in false claims. Press Release

Legislative Activity –

Votes and Committee Activity –

  • On June 27, the House Appropriations Labor, Health and Human Services, Education, and Related Agencies Subcommittee advanced the Departments of Labor, Health and Human Services, Education, and Related Agencies appropriations for fiscal year (FY) 2025 by voice vote. The bill heads to the full Committee for consideration. Bill Summary Bill Text Press Release
  • Also on June 27, the House Ways & Means Committee advanced four health bills out of Committee. The bills now head to the full House for consideration. Press Release
    • The Ensuring Patient Access to Critical Breakthrough Products Act of 2023 (H.R. 1691) passed by a vote of 36-5. The bill would ensure prompt coverage of breakthrough devices under the Medicare program. Bill Text One-Pager
    • The Nancy Gardner Sewell Medicare Multi-Cancer Early Detection Screening Coverage Act (H.R. 2407) passed by a vote of 38-0. The bill would provide for Medicare coverage of multi-cancer early detection screening tests. Bill Text One-Pager
    • The American Medical Innovation and Investment Act (H.R. 8816) passed by a vote of 40-0. The bill would provide for a cognitive impairment detection benefit under the Medicare program. Bill Text One-Pager
    • The Treat and Reduce Obesity Act (TROA) of 2023 (H.R. 4818) passed by a vote of 36-4. The bill would provide for the coordination of programs to prevent and treat obesity. Bill Text One-Pager

Introduced Legislation –

  • On June 25, Rep. Burlison (R-MO) introduced the Improving Access to Long-Term Care Insurance Act (H.R. 8820), which would provide an above-the-line deduction for long-term care insurance premiums and reduce certain tax credits. Bill Text Press Release
  • On June 26, Rep. Caraveo (D-CO) and seven bipartisan cosponsors introduced the Maternal and Infant Syphilis Prevention Act (H.R. 8839), which would issue guidance to states on best practices for screening and treatment of congenital syphilis under Medicaid and CHIP. Bill Text Press Release
  • Also on June 26, Rep. Schakowsky (D-IL) and seven cosponsors introduced the Affordable and Safe Prescription Drug Importation Act (H.R. 8848), which would allow for the importation of affordable and safe drugs by wholesale distributors, pharmacies, and individuals. Press Release