Health Care Watch: April 15, 2024
The following Federal Health Policy (FHP) Strategies Weekly Health Care Watch provides a summary of legislative and regulatory health care activities from April 7– April 13. 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 April 8, Energy & Commerce Committee Chair Cathy McMorris Rodgers (R-WA) and Senate Commerce Committee Chair Maria Cantwell (D-WA) released draft legislation that would allow people to sue data companies for privacy violations of their health information that’s not protected by federal health privacy law. The draft legislation, entitled the American Privacy Rights Act, would limit the type of data companies can collect and use and would preempt many state data privacy laws, with exemptions for certain health and consumer protection laws.
On April 10, the Energy & Commerce Health Subcommittee held a hearing entitled Legislative Proposals to Support Patient Access to Telehealth Services. The hearing examined a variety of legislation that aimed to expand, enshrine, and reform telehealth services. A list of all legislation discussed can be found here.
On April 10, Rep. Tom Cole (R-OK) was named as the next chair of the House Appropriations Committee. Rep. Cole is giving up his Rules Committee chairmanship, with Rep. Michael Burgess (R-TX) succeeding him.
On April 11, Energy & Commerce Committee Chair McMorris Rodgers (R-WA) announced updates to Republican Members’ subcommittee assignments. Rep. Troy Balderson (R-OH) will leave the Communications and Technology Subcommittee to join the Health Subcommittee. Additionally, three Republican subcommittee members, Reps. Greg Pence (R-IN), Larry Bucshon (R-IN), and Michael Burgess (R-TX), are not seeking reelection. A list of all subcommittee assignments can be found here.
Senate
On April 9, Majority Whip Dick Durbin (D-IL), Homeland Security and Governmental Affairs Committee Chairman Gary Peters (D-MI) and Finance Committee Chairman Ron Wyden (D-OR) introduced legislation aimed at bolstering the federal government’s capacity to find and prosecute pandemic-related fraud. The $1.3 billion bill would devote about $675 million toward guarding programs from identity theft and would allocate roughly $550 million to the Justice Department and leading inspectors general to bolster their oversight of federal spending. The bill would also give federal law enforcement officials additional powers and more time to investigate crimes targeting certain pandemic relief programs.
On April 9, Health, Education, Labor & Pensions (HELP) Committee Chairman Bernie Sanders (I-VT) released a draft legislative proposal to address the Long COVID crisis. The legislation would provide $1 billion in mandatory funding per year for 10 years to the National Institutes of Health (NIH), create a centralized coordinating entity for the majority of Long COVID research activities, and require NIH to establish a new grant process for clinical trials related to Long COVID. Sen. Sanders has also requested input from the Long COVID community on the proposal.
REGULATORY UPDATE
On April 5, the Food & Drug Administration (FDA) revised the indications of both approved CAR T-cell therapies for relapsed multiple myeloma to allow the use of these therapies earlier in the course of the disease. Johnson & Johnson and Legend Biotech’s CARVYKTI is now FDA-approved for the treatment of adult patients with relapsed or refractory (r/r) multiple myeloma who have received at least one prior line of therapy, including a proteasome inhibitor and an immunomodulatory agent and are refractory to lenalidomide. Bristol Myers Squibb’s ABECMA is now approved for the treatment of adult patients with r/r multiple myeloma who have received at least two prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody.
On April 9, the Health Resources and Services Administration (HRSA) announced the availability of $51 million for funding opportunity for HRSA-funded health centers to implement innovative approaches to support transitions in care for people leaving incarceration. The action explicitly supports the provision of health services to individuals during the 90 days prior to their release. For this funding opportunity, approximately 51 health centers will implement approaches that focus on: reducing drug overdose risk; addressing mental health and substance use disorder treatment needs; managing chronic conditions; and preventing, screening, diagnosing, and treating hepatitis C, HIV, syphilis, and other infectious diseases. Applications are due on June 10, 2024.
On April 10, the Centers for Medicare & Medicaid Services (CMS) released the Fiscal Year (FY) 2025 Medicare Hospital Inpatient Prospective Payment System (IPPS) and Long-term Care Hospital Prospective Payment System (LTCH PPS) proposed rule. The rule proposes a 2.6% increase in Medicare reimbursements for inpatient hospitals that successfully participate in the Hospital Inpatient Quality Reporting Program and are meaningful electronic health record users, an estimated increase of $3.2 billion over the current year. The increase reflects a projected FY 2025 hospital market basket percentage increase of 3%, reduced by a 0.4 percentage point productivity adjustment. The proposed rule also includes a 2.8% increase in the standard payment rate for LTCHs, coupled with an increase for certain discharges. Additionally, the rule proposes new equity incentives for hospitals by: 1) adding new social determinants of health data elements into LTCH quality reporting; 2) extending a temporary policy that addresses wage index disparities affecting low-wage index hospitals, which includes many rural hospitals; and 3) including a separate payment under the IPPS for small, independent hospitals to establish and maintain a buffer stock of essential medicines for use during future shortages. The rules also proposes to test a mandatory episode-based payment model called the Transforming Episode Accountability (TEAM) Model. This five-year model would begin in 2026 and would incentivize coordination between care providers during a surgery, as well as the services provided during the 30 days that follow and require referral to primary care services to support continuity of care and drive positive long-term health outcomes. A fact sheet detailing the final rule can be found here. Comments are due on June 10, 2024.
On April 10, FDA announced expanded actions for Jiangsu Shenli Medical Production Co. Ltd. with an additional import alert for not meeting device quality system requirements, to prevent all plastic syringes by this manufacturer from entering the United States. Until further notice FDA recommends that U.S. suppliers of plastic syringes, consumers, health care providers and facilities immediately transition away from using all models of plastic syringes manufactured by Jiangsu Shenli Medical Production Co Ltd.
On April 11, the Centers for Disease Control and Prevention (CDC) released an updated public health data strategy for 2024-2025. The strategy addresses challenges in data exchange between healthcare organizations and public health authorities and between state, tribal, local, territorial and federal public health authorities.
White House
On April 10, President Biden released a statement on Black maternal health. He reiterated the Administration’s actions and commitment to addressing the high rate of mortality for Black mothers and their children. He stated that the Administration will continue to expand its work and research on this topic.
On April 12, President Biden released an Executive Order (EO) on COVID-19 and public health preparedness and response. The Executive Order transfers roles and responsibilities established by other EOs related to COVID-19 to the Office of Pandemic Preparedness and Response Policy (OPPR). Transferred duties include organizing and mobilizing the U.S. government to provide a unified and effective response to combat COVID-19 and ensuring a data-driven response to COVID-19 and future high-consequence public health threats.
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
Alternative Payment Model Updates; Increasing Organ Transplant Access (IOTA) Model (CMS-5535); Proposed Rule; 11/9/23
Ensuring Access to Medicaid Services (CMS-2442); Final Rule; 1/26/24
Minimum Staffing Standards for Long-Term Care Facilities and Medicaid Institutional Payment Transparency Reporting (CMS-3442); Final Rule; 3/1/24
Misclassification of Drugs, Program Administration and Program Integrity Updates Under the Medicaid Drug Rebate Program (CMS-2434); Final Rule; 3/22/24
FDA
Medical Devices; Laboratory Developed Tests; Final Rule; 3/1/24
Enforcement Policy for Certain In Vitro Diagnostic Devices for Immediate Public Health Response in the Absence of a Declaration under Section 564.; Notice; 3/5/24
Consideration of Enforcement Policies for Tests During a Section 564 Declared Emergency; Draft Guidance for Industry and Food and Drug Administration Staff; Availability; Notice; 3/7/24
Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies; Guidance for Industry; Notice; 4/10/24
OCR
Rulemaking on Discrimination on the Basis of Disability in Health and Human Services Programs or Activities; Final Rule; 3/4/24
Health and Human Services Grants Regulation; Final Rule; 3/6/24
ONC
Health Data, Technology, and Interoperability: Patient Engagement, Information Sharing, and Public Health Interoperability; Proposed Rule; 1/18/24
REPORTS
Government Accountability Office (GAO)
On April 8, GAO released a report examining health centers’ revenue, grant funding, and methods for meeting certain access-to-care requirements. GAO found that in 2022, nearly 1,400 health centers provided primary and preventive health services to more than 30 million people, regardless of their ability to pay. Health centers' total revenue rose from about $28.7 billion in 2018 to $42.9 billion in 2022—an increase of more than $14 billion. GAO stated that the largest single source of revenue was Medicaid, accounting for over one-third of total revenue each year, and the second largest revenue source each year was grants, including those provided by HRSA. GAO made no recommendations in this report.
Office of Inspector General (OIG)
On April 11, OIG released a report examining Ohio’s Medicaid eligibility actions during the unwinding period. OIG found that of the 1,211,991 enrollees covered under the audit period, OIG sampled 140 enrollees and determined that 9 enrollees had their Medicaid enrollment incorrectly determined. Based on sample results, OIG estimated that Ohio incorrectly renewed or terminated Medicaid eligibility for 78,486 of the 1,211,991 Medicaid enrollees during the audit period. OIG recommends that Ohio: 1) take appropriate action with respect to the incorrect Medicaid eligibility determinations identified; 2) provide periodic training to caseworkers about verifying and documenting enrollees’ income during the renewal process; and 3) provide additional training to caseworkers about using current information when conducting enrollee eligibility determinations.
UPCOMING HEARINGS
House
Energy & Commerce Committee
Subcommittee on Health
April 16; 10:00 AM; 2123 Rayburn
Examining Health Sector Cybersecurity in the Wake of the Change Healthcare Attack
Subcommittee on Health
April 17; 2:00 PM; 2123 Rayburn
Fiscal Year 2025 Department of Health and Human Services Budget
Witness: HHS Secretary Xavier Becerra
Subcommittee on Oversight & Investigations
April 16; 10:30 AM; 2322 Rayburn
Examining How Improper Payments Cost Taxpayers Billions and Weaken Medicare and Medicaid
Education and Workforce Committee
Subcommittee on Health, Employment, Labor, and Pensions
April 16; 10:15 AM; 2175 Rayburn
ERISA’s 50th Anniversary: The Path to Higher Quality, Lower Cost Health Care
Appropriations Committee
Subcommittee on Agriculture, Rural Development, Food & Drug Administration
April 18; 9:00 AM; 2362-A Rayburn
Fiscal Year 2025 Budget Request for the Food and Drug Administration
Witnesses: FDA Commissioner Dr. Robert Califf
Senate
Special Committee on Aging
April 16; 10:00 AM; SD-562
The Long-Term Care Workforce: Addressing Shortages and Improving the Profession
Witnesses: Nicholas Smith, Direct Support Professional/Behavioral Health Specialist Lead, SPIN; Brooke Vogleman, Licensed Practical Nurse, TLC Management; Matthew Connell EdD, Sector Vice President for Healthcare, Ivy Tech Community College; Jasmine Travers, Assistant Professor, New York University Rory Meyers College of Nursing
Appropriations Committee
Subcommittee on Labor, Health and Human Services, Education, and Related Agencies
April 16; 10:00 AM; 138 Dirksen
A Review of the President’s Fiscal Year 2025 Budget Request for the Department of Health and Human Services
Witness: HHS Secretary Xavier Becerra
Finance Committee
April TBD
Hearing on UnitedHealth Group
Potential Witnesses: United Health Group CEO Andrew Witty
OTHER POLICY NEWS
On April 8, Virginia Governor Glenn Youngkin vetoed a bill that would have established a prescription drug affordability board (PDAB) in the state, rejecting it as a price control measure, and instead called for more transparency of drug prices. Under the legislation, the PDAB would have the authority to set an upper payment limit on a drug and use Medicare’s maximum fair price when applicable. The bill had passed the Virginia Senate 25-15 and House 52-46.
On April 9, it was reported that HHS Secretary Xavier Becerra is considering leaving the Biden administration to mount a run for California governor in 2026.
On April 11 and 12, the Medicare Payment Advisory Commission (MedPAC) held its April 2024 public meetings. Commissioners discussed telehealth status update, inpatient rehabilitation facility (IRF) payment alternatives, the Medicare physician fee schedule, and generic drug pricing. Transcripts from all meetings will be available here in the coming week.
On April 11 and 12, the Medicaid and CHIP Payment and Access Commission (MACPAC) held its April 2024 public meetings. Commissioners Medicaid demographic data collection, Medicaid and CHIP financing, state Medicaid agency contracts, home-and community-based services, hospital supplemental payment analyses and Medicaid unwinding. Transcripts from all meetings will be available here in the coming week.