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April 22, 2024

This Week in Health Policy for April 22

This Week (April 22 - 26)

The House and Senate are scheduled to be in recess this week and will return the week of April 29th.

Last Week (April 15 - 19)

Health Care Highlights

HRSA issues 340B Administrative Dispute Resolution process final rule. On Thursday (April 18), the Health Resources and Services Administration (HRSA) issued a final rule updating the 340B Drug Discount Program's Administrative Dispute Resolution (ADR) process. The updates, which are set to take effect in July, ensure the ADR process is open to all 340B covered entities and all claim disputes with drug companies. Among other things the rule:

  • Restructures the ADR panel so it is more representative of 340B subject-matter experts;
  • Allows covered entities to submit claims for instances in which they feel they have been overcharged by a pharmaceutical company including where the covered entity is denied access to 340B pricing;
  • Allows claims for ADR panel review even if the particular issue at stake is subject to concurrent federal court review;
  • Requires decisions be reached by the ADR process within one year of submission of claims for ADR review;
  • Establishes a reconsideration process for parties dissatisfied with the 340B ADR panel decision.

Senator raises concerns about FDA's CDS software policy. On Wednesday (April 17), Senate Health, Education, Labor, and Pensions (HELP) Committee ranking member Bill Cassidy (R-LA) sent a letter to Food and Drug Administration Commissioner Robert Califf raising concerns that the agency's guidance classifying some clinical decision support (CDS) software as medical devices subjects small health care software developers to unnecessary regulation.

White House launches global health security initiative. On Tuesday (April 16), the Biden administration launched its Global Health Security Strategy, which is designed to drive action across federal agencies and the private sector to improve global health preparedness and response. The strategy outlines three overarching goals: Strengthen global health security capacities through bilateral partnerships; Catalyze political commitment, financing and leadership to achieve health security; and Increase linkages between health security and complementary programs to maximize impact. As part of the strategy, the Biden administration announced partnerships with 50 countries.

CMS publishes fact sheet for potential Medicare coverage of PrEP using antiviral drugs. On Tuesday (April 16), CMS published a fact sheet ahead of a potential National Coverage Determination (NCD) for Preexposure Prophylaxis (PrEP) using antiretroviral drugs to prevent HIV infection.

Hearings, Markups, and Other Committee Activity

House Energy & Commerce Health Subcommittee held a hearing on "Examining Health Sector Cybersecurity in the Wake of the Change Healthcare Attack." On Tuesday (April 16), the Subcommittee heard from a panel of cybersecurity experts and representatives from hospitals and physician practices. During the hearing, much of the discussion focused on the cybersecurity risks posed by consolidation in health care, the ways payers and the federal government can mitigate the impact of cybersecurity incidents on patient care going forward, and ways to help providers and health care organizations increase and maintain cybersecurity platforms without increasing burdensome regulations.

  • More information available here.

House Energy & Commerce Health Subcommittee held a hearing on "Examining How Improper Payments Cost Taxpayers Billions and Weaken Medicare and Medicaid." On Tuesday (April 16), the Subcommittee held a hearing during which members heard testimony from representatives from the Government Accountability Office, HHS' Office of Inspector General, the Medicare Payment Advisory Commission, and the Medicaid and CHIP Payment and Access Commission. During the hearing, discussion focused on potential solutions to reduce improper payments in the Medicare and Medicaid programs, including the need for transparency.

  • More information available here.

House Committee on Education & the Workforce Subcommittee on Health, Employment, Labor, and Pensions held a hearing on "ERISA's 50th Anniversary: The Path to Higher Quality, Lower Cost Health Care." On Tuesday (April 16), the Subcommittee heard from a panel of witnesses representing employers, purchasers, legal experts, and policy experts on ways to update and strengthen the Employee Retirement Income Security Act of 1974 (ERISA). During the hearing, there was bipartisan support for ERISA with general consensus on the need to increase transparency and ensure employer plans have access to claims data. Key issues discussed include the importance of maintaining ERISA pre-emption, whether to extend fiduciary responsibility to pharmacy benefit managers and other third-party administrators, and potential changes to the taxation of employer plans. The hearing follows a request for information from the House Committee on Education & the Workforce on ways to bolster ERISA.

  • More information available here.

House Appropriations Subcommittee on Military Construction, Veterans Affairs, and Related held a budget hearing on "FY 2025 Request for the Department of Veterans Affairs." On Tuesday (April 16), the Subcommittee heard testimony from VA Secretary Denis McDonough on President Biden's FY 2025 budget request for the VA. During the hearing, discussion included VA programs related to telehealth, veteran suicide, prevention, and VA and DOD electronic health record integration, and more.

  • More information available here.

House Energy & Commerce Innovation, Data, and Commerce Subcommittee held a hearing on "Legislative Solutions to Protect Kids Online and Ensure Americans' Data Privacy Rights." On Wednesday (April 17), the Subcommittee held a hearing during which lawmakers discussed the importance of passing data privacy legislation that protects individual rights, particularly related to children. Several pieces of legislation were discussed, with most of the discussion focused on the American Privacy Rights Act (APRA), Kids Online Safety Act (KOSA) and the Children and Teens' Online Privacy Protection Act (COPPA 2.0). Lawmakers heard testimony from several witnesses who emphasized the importance of passing legislation such as APRA. However, many also provided recommendations to the Subcommittee to improve the bill further.

  • More information available here.

House Energy & Commerce Health Subcommittee and the Senate Appropriations Committee held separate hearings on "Fiscal Year 2025 Department of Health and Human Services Budget." This week, HHS Secretary Xavier Becerra testified before both the House Energy & Commerce Health Subcommittee and the Senate Appropriations Committee during which he fielded questions on HHS' implementation of the No Surprises Act, ongoing questions related to care for unaccompanied minor children, ways the Biden administration is addressing the fentanyl crisis, and more.

  • More information on House committee hearing available here.
  • More information on Senate committee hearing available here.

Senate Special Committee on Aging held a hearing on "The Long-Term Care Workforce: Addressing Shortages and Improving the Profession." On Tuesday (April 16), the Committee held a hearing to discuss ways to support and reform the long-term care workforce. During the hearing, Chair Robert Casey (D-PA) spoke about the Long-Term Care Workforce Support Act, which would support pathways to enter the workforce, improve compensation for the direct care workforce, ensure safe working environments and more.

  • More information available here.

Reports, Studies, and Journals

Congressional Budget Office: Medicare Accountable Care Organizations: Past Performance and Future Directions. The report summarizes the latest findings on Medicare ACOs and factors that have contributed or limited their ability to generate net budgetary savings, finding ACOs led by independent physician groups, those with a larger proportion of primary care providers, and whose initial baseline spending was higher than the regional average were associated with greater savings.

Commonwealth Fund: Advancing Racial Equity in U.S. Health Care. The report analyzes 25 metrics that track health care access, outcomes, and quality of care for five racial/ethnic groups in each U.S. state and found significant health disparities nationwide.

Centers for Medicare and Medicaid Services: Maryland Total Cost of Care Model Evaluation of the First Four Years (2019—2022). The report finds the model in its first four years had positive effects on spending and service use and reduced disparities in quality-of-care measures for beneficiaries by race and location.

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Contact Information

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Washington Council Ernst & Young