Health Care Watch: June 10, 2024
The following Federal Health Policy (FHP) Strategies Weekly Health Care Watch provides a summary of legislative and regulatory health care activities from June 2 – June 8. 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 June 4, the Energy & Commerce Oversight & Investigations Subcommittee held a hearing entitled Oversight of 340B Drug Pricing Program. The hearing examined the current 340B program and discussed potential reforms including additional transparency requirements. Various witnesses testified on the benefits and challenges of the program.
On June 6, Reps. Diana DeGette (D-CO) and Larry Bucshon (R-IN) sent a letter to stakeholders, interest groups, and health care advocates requesting information on what Congress can do to bring about the next generation of medical treatments to market. The letter discusses the 21st Century Cures Act and asks for input on policies, reforms, and support mechanisms for inclusion in the Cures 2.0 Act. Feedback is due by August 2.
Senate
On June 3, Senate Democrats, led by Sens. Tammy Duckworth (D-IL), Patty Murray (D-WA) and Cory Booker (D-NJ), released a legislative package that would preserve and expand access to assisted reproductive technologies, including in vitro fertilization (IVF). A fact sheet detailing the four pieces of legislation within the package can be found here.
On June 5, Finance Committee Chairman Ron Wyden (D-OR) sent a letter to Department of Health & Human Services (HHS) Secretary Xavier Becerra asking that the Department take immediate, enforceable steps to require large health care companies to improve their cybersecurity practices in light of the recent Change Healthcare cyberattack.
On June 5, a group of Senate Democrats, led by Sen. Chris Murphy (D-CT), sent a letter to the Biden Administration urging the administration to finalize a proposed rule from last year that would strengthen the Mental Health Parity and Addiction Equity Act of 2008. The letter states that the proposed rule would significantly help the national mental health and substance-use disorder crises.
On June 6, Finance Committee Chairman Wyden and committee members Chuck Grassley (R-IA), Ben Cardin (D-MD), and Todd Young (R-IN) sent a letter to Centers for Medicare & Medicaid Services (CMS) Administrator Chiquita Brooks-LaSure calling on the agency to take additional measures to prevent abuse of pancreata procurement by organ procurement organizations (OPOs) after rates of pancreata recovery have “dramatically increased” in recent years. Last year, the Senators launched an inquiry seeking information from 10 OPOs about their pancreata procurement practices. The Senators found that the total number of pancreata recovered for research increased from 169 in 2018 to 1606 in 2022, representing an 850% increase. In 2018, 87.6% of these pancreata were used for research related to islet cell transplantation, while in 2022 only 47.9% of the pancreata were used for the same purpose.
REGULATORY UPDATE
On May 31, HHS announced that providers affected by the ransomware attack at Change Healthcare can delegate to Change Healthcare the tasks of providing the required Health Insurance Portability and Accountability Act of 1996 (HIPAA) breach notifications on their behalf.
On June 3, HHS’ Health Resources and Services Administration (HRSA) announced a combined investment of $15 million over four years through the Rural Maternity and Obstetrics Management Strategies (Rural MOMS) Program to improve maternal health in rural communities and a new program focused on strengthening maternal care and reducing disparities in the Delta region (within Alabama, Arkansas, Illinois, Kentucky, Louisiana, Mississippi, Missouri, and Tennessee). The Rural MOMS Program awardees announced will each receive start-up funding of almost $4 million over four years to test out new approaches to support, enhance, and expand access to maternal care, including obstetric care, in rural communities and will focus on a network model-approach to coordinate care across rural hospitals, medical centers, community health centers and rural health clinics.
On June 4, HHS, through CMS, and in partnership with the Substance Abuse and Mental Health Services Administration (SAMHSA), announced the participation of 10 new states – Alabama, Illinois, Indiana, Iowa, Kansas, Maine, New Hampshire, New Mexico, Rhode Island and Vermont – in the Certified Community Behavioral Health Clinic (CCBHC) Medicaid Demonstration Program. The CCBHC Medicaid Demonstration Program provides states with sustainable funding that helps them expand access to mental health and substance use services.
On June 4, the Food & Drug Administration’s (FDA) Psychopharmacologic Drugs Advisory Committee voted 10-2 against the use of MDMA for treating PTSD. The panel stated that the data does not show MDMA is effective in treating PTSD and that the benefits don’t outweigh its risks to patients.
On June 5, FDA’s Vaccines and Related Biological Products Advisory Committee voted unanimously to recommend that this fall’s COVID-19 vaccines target the JN.1 variant.
On June 7, HHS issued five reports showing gains in health care coverage and highlighting increases in coverage among minority communities since the implementation of the Affordable Care Act’s (ACA) coverage provisions. HHS attributes the coverage gains to the Administration’s efforts to increase access to affordable, quality health care, especially in underserved communities, and “underscore the importance of the Inflation Reduction Act’s tax breaks that lower health care costs and make marketplace plans more affordable.” HHS also announced a new $500 million investment in Navigators, who play a key role in helping people across the country sign up for health care, particularly in underserved communities.
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
CY 2025 Changes to the End-Stage Renal Disease (ESRD) Prospective Payment System and Quality Incentive Program (CMS-1805); Proposed Rule; 4/18/24
CY 2025 Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Medicare Part B (CMS-1807); Proposed Rule; 4/18/24
CY 2025 Hospital Outpatient PPS Policy Changes and Payment Rates and Ambulatory Surgical Center Payment System Policy Changes and Payment Rates (CMS-1809); Proposed Rule; 4/24/24
CY 2025 Home Health Prospective Payment System Rate Update and Home Infusion Therapy and Home IVIG Services Payment Update (CMS-1803); Proposed Rule; 4/26/24
Mitigating the Impact of Anomalous Increases in Billing on Medicare Shared Savings Program Financial Calculations (CMS-1799); Proposed Rule; 5/28/24
FDA
Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies; Guidance for Industry; Notice; 4/10/24
Addressing Misinformation About Medical Devices and Prescription Drugs: Questions and Answers; Draft Guidance for Industry; Availability; Agency Information Collection Activities; Proposed Collection; Notice; 5/21/24
ONC
Health Data, Technology, and Interoperability: Patient Engagement, Information Sharing, and Public Health Interoperability; Proposed Rule; 1/18/24
REPORTS
Congressional Budget Office
On June 4, the Congressional Budget Office (CBO) announced that it will publish An Update to the Budget and Economic Outlook: 2024 to 2034 on June 18. The report will provide updated 10-year projections of the federal budget and the U.S. economy. On June 27, CBO will publish An Analysis of the Discretionary Spending Proposals in the President’s 2025 Budget. That report will provide an analysis of how the discretionary spending proposals in the President’s 2025 budget compare with CBO’s updated baseline projections.
Government Accountability Office (GAO)
On June 4, GAO released a report examining HHS priority open recommendations. The report outlines 35 open recommendations that HHS should prioritize in seven areas: 1) public health emergency preparedness, including the COVID-19 response; 2) public health and human services program oversight; 3) FDA oversight; 4) Medicaid program; 5) Medicare program; 6) Improper payments in Medicaid and Medicare; and 7) Health care infrastructure, information technology, and cybersecurity. For Medicaid, GAO recommendations include that HHS collect complete data on beneficiary blood lead screenings, ensure greater transparency for certain Medicaid demonstration applications, and improve oversight of state-directed payments for managed care. For Medicare, recommendations include that HHS fully validate Medicare Advantage (MA) encounter data and account for Medicaid payments that offset uncompensated care costs when making Medicare uncompensated care payments to individual hospitals. GAO also recommended that HHS improve the accuracy of the adjustment to MA payments to account for differences in diagnostic coding practices between MA and Medicare fee-for-service.
UPCOMING HEARINGS
House
Budget Committee
June 13; 10:00 AM; 210 Cannon
Medicare and Social Security: Examining Solvency and Impacts to the Federal Budget
Witnesses: Paul Spitalnic, Chief Actuary, CMS; Stephen Goss, Chief Actuary, Social Security Administration
Energy & Commerce Committee
Subcommittee on Health
June 13; 10:00 AM; 2123 Rayburn
Checking-In on CMMI: Assessing the Transition to Value-Based Care
Witness: Elizabeth Fowler, Deputy Administrator and Director, Center for Medicare and Medicaid Innovation, CMS
Oversight and Accountability Committee
Early June; TBD
Hearing on Pharmacy Benefit Manager (PBM) Practices
Ways and Means Committee
TBD
Markup of Health Care Innovation Policies
Senate
Finance Committee
June 12; 10:00 AM; G-50 Dirksen
Youth Residential Treatment Facilities: Examining Failures and Evaluating Solutions
Witnesses: Marc Miller (Invited), President and Chief Executive Officer, Universal Health Systems; Reagan Stanford, Abuse and Neglect Managing Attorney, Disability Rights Arkansas; Elizabeth Manley, Faculty and Senior Advisor for Health and Behavioral Health Policy, Innovations Institute, University of Connecticut School of Social Work