Health Care Watch: July 8, 2024
The following Federal Health Policy (FHP) Strategies Weekly Health Care Watch provides a summary of legislative and regulatory health care activities from June 30 – July 6. Where available, hyperlinks are included to the relevant documents. Please let us know if you have any questions or would like additional information on the items below.
LEGISLATIVE UPDATE
House
On July 1, Energy & Commerce Committee Chair Cathy McMorris Rodgers (R-WA), Ways & Means Committee Chairman Jason Smith (R-MO), and Judiciary Committee Chairman Jim Jordan (R-OH) sent letters to U.S. Department of Health & Human Services (HHS) Inspector General Christi Grimm and Government Accountability Office (GAO) Comptroller General Gene Dodaro asking for systemic reviews of Obamacare enrollment to determine the breadth of improper enrollment and its underlying causes. The letters come following the release of a paper from Paragon Health Institute, which estimates that four to five million people are improperly enrolled in fully subsidized Obamacare plans, with incomes exceeding the qualifying level, at a cost of $15 to $26 billion per year to taxpayers.
The House returns from its recess on July 8.
Senate
On July 2, Finance Committee Chairman Ron Wyden (D-OR) and Senator Elizabeth Warren (D-MA) sent a letter to the GAO urging it to update its 2019 report on state Medicaid programs’ coverage of mifepristone. The 2019 GAO report found that 14 states were not in compliance with federal law by not covering mifepristone in their Medicaid program.
The Senate returns from its recess on July 8.
REGULATORY UPDATE
On June 28, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule entitled, Medicare Program: Mitigating the Impact of Significant, Anomalous, and Highly Suspect Billing Activity on Medicare Shared Savings Program Financial Calculations in Calendar Year 2023. CMS stated that the proposed rule is part of a larger strategy to address significant, anomalous, and highly suspect billing activity for selected intermittent urinary catheters within ACO reconciliation. CMS noted that additional information will be forthcoming in the Physician Fee Schedule Proposed Rule, which is expected to be released the week of July 8. A fact sheet detailing the proposed rule can be found here. Comments are due July 29, 2024.
On July 1, the Health Resources and Services Administration (HRSA) announced more than $200 million to support 42 programs across the country aimed at improving care for older Americans, including those experiencing Alzheimer’s disease and related dementias. HRSA’s Geriatrics Workforce Enhancement Program will train primary care physicians, nurse practitioners, and other health care clinicians to provide age-friendly and dementia-friendly care for older adults. The program also focuses on providing families and other caregivers of older adults with the knowledge and skills to help them best support their loved ones.
On July 2, the Biomedical Advanced Research and Development Authority (BARDA) announced that it will provide approximately $176 million to Moderna for development of an mRNA-based pandemic influenza vaccine. The award includes a “fair pricing agreement” and the option for large-scale production in case of a flu pandemic. The award was made through BARDA’s new Rapid Response Partnership Vehicle (RRPV) Consortium, managed by Advanced Technology International (ATI).
On July 2, CMS approved the latest in a series of Medicaid and Children’s Health Insurance Programs (CHIP) demonstrations that will allow Illinois, Kentucky, Oregon, Utah, and Vermont to provide coverage before being released from prison. The Medicaid Reentry Section 1115 Demonstration Opportunity allows a state to cover certain services not otherwise coverable in Medicaid and CHIP up to 90 days before an eligible person’s expected release from incarceration. This includes coverage of substance-use disorder (SUD) treatment before a Medicaid or CHIP beneficiary is released from jail, prison, or a youth correctional facility.
On July 2, the Food & Drug Administration (FDA) approved Eli Lilly’s Alzheimer’s drug Kisunla (donanemab-azbt) injection for the treatment of Alzheimer’s disease. The drug is approved for Alzheimer's treatment for adults with early symptomatic Alzheimer's disease (AD), which includes people with mild cognitive impairment (MCI) and people with the mild dementia stage of AD, with confirmed amyloid pathology.
The CY 2025 Physician Fee Schedule (PFS) Proposed Rule and CY 2025 Hospital Outpatient Prospective Payment System (OPPS) Proposed Rule have cleared OMB review and are expected to be released early next week.
WHITE HOUSE
On July 2, the Biden Administration released a statement reaffirming its commitment to enforcement of the Emergency Medical Treatment and Active Labor Act (EMTALA) following the Supreme Court’s decision in Moyle v. United States. Specifically, HHS Secretary Xavier Becerra and CMS Administrator Chiquita Brooks-LaSure sent a letter to hospital and provider associations across the country reminding them that it is a hospital’s legal duty to offer necessary stabilizing medical treatment (or transfer, if appropriate) to all patients in Medicare-participating hospitals who are found to have an emergency medical condition. CMS also announced that the investigation of EMTALA complaints would proceed in Idaho while litigation continues in the lower courts.
RULES AT THE WHITE HOUSE OFFICE OF MANAGEMENT & BUDGET (OMB)
Pending Review
CMS
Healthcare System Resiliency and Modernization (CMS-3426); Proposed Rule; 10/12/23
Misclassification of Drugs, Program Administration and Program Integrity Updates Under the Medicaid Drug Rebate Program (CMS-2434); Final Rule; 3/22/24
Administrative Simplification: Modifications to NCPDP Retail Pharmacy Standards (CMS-0056); Final Rule; 6/27/24
Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals; the Long-Term Care Hospital Prospective Payment System; and FY 2025 Rates (CMS-1808); Final Rule; 6/28/24
FY 2025 Skilled Nursing Facility (SNFs) Prospective Payment System and Consolidated Billing and Updates to the Value-Based Purchasing and Quality Reporting Programs (CMS-1802); Final Rule; 6/28/24
FY 2025 Inpatient Rehabilitation Facility (IRF) Prospective Payment System Rate Update and Quality Reporting Program (CMS-1804); Final Rule; 7/2/24
FDA
Recommendations for Investigational and Licensed COVID-19 Convalescent Plasma; Guidance for Industry; Availability; Notice; 7/2/24
REPORTS
Office of Inspector General (OIG)
On July 2, HHS’ OIG released a report examining 2023 performance data for the senior Medicare patrol (SMP) projects. OIG found that the COVID-19 pandemic continued to present challenges for the SMP projects that limited their in-person activities. In 2023, the 54 SMP projects had a total of 5,532 active team members who conducted a total of 22,356 group outreach and education events, reaching an estimated 1.2 million people. Additionally, the projects had 270,348 individual interactions with, or on behalf of, a Medicare beneficiary. Additionally, OIG found that for 2023, the SMP projects reported $111,277,683 in expected Medicare recoveries. OIG stated that Association for Community Living (ACL) needs to work with SMP projects to further focus on and document expected Medicare and Medicaid recoveries, additional Medicare and Medicaid recoveries, cost avoidance, and savings both to beneficiaries and to others to the extent possible.
UPCOMING HEARINGS
House
Appropriations Committee
July 10; 9:00AM; 2359 Rayburn
Full Committee Markup: Fiscal Year 2025 Labor, Health and Human Services, and Education, Transportation, Housing and Urban Development, and Agriculture, Rural Development, and Food and Drug Administration Bills and Revised Subcommittee Allocations
Oversight and Accountability Committee
TBD
Hearing on Pharmacy Benefit Manager (PBM) Practices
Senate
Appropriations Committee
July 11; 9:30 AM; 106 Dirksen
Full Committee Markup of the MilCon-VA, Agriculture-FDA, and Legislative Branch Appropriations Acts and Fiscal Year 2025 Subcommittee Allocations
Special Committee on Aging
July 11; 10:00 AM; 138 Dirksen
Health Care Transparency: Lowering Costs and Empowering Patients
Witnesses: Chris Whaley, Associate Director of the Center for Advancing Health Policy through Research, Associate Professor of Health Services, Policy and Practice, Brown University School of Public Health; Chris Deacon, Principal Owner, VerSan Consulting, LLC; Cora Opsahl, Health Fund Director, 32BJ Health Fund; Sophia Tripoli, Senior Director of Health Policy, Families USA
HELP Committee
July 11; 10:00 AM; 562 Dirksen
What Can Congress Do to End the Medical Debt Crisis in America?
September 24; 10:00 AM; SD-562
ADDITIONAL POLICY NEWS
On July 1, in a 6-3 decision in the case of Corner Post, Inc. v. Board of Governors of the Federal Reserve System, the Supreme Court ruled that agency actions can be challenged long after regulations are finalized. The Court held that plaintiffs can file an Administrative Procedure Act (APA) challenge to a federal regulation based on when the alleged injury occurs, not when the regulation is finalized. The decision opens the door to lawsuits seeking to invalidate a broad range of regulations based on the new, more intensive scrutiny that will be applied to agencies based on the Court’s recent decision to overturn Chevron deference in Loper Bright Enterprises et al. v. Raimondo.