Health Care Watch: May 13, 2024
The following Federal Health Policy (FHP) Strategies Weekly Health Care Watch provides a summary of legislative and regulatory health care activities from May 6 – May 10. 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 May 8, the Ways & Means Committee held a markup of a package of six pieces of legislation aimed at extending Medicare telehealth services. Namely, the committee advanced, in a 41-0 vote, H.R. 8261, the Preserving Telehealth, Hospital, and Ambulance Access Act which would extend pandemic-era Medicare telehealth flexibilities through 2026 and hospital at home through 2029.
On May 14, the House will consider:
Senate
On May 6, Health, Education, Labor & Pensions (HELP) Committee Chairman Bernie Sanders (I-VT) announced that he will run for reelection.
On May 9, HELP Committee Ranking Member Bill Cassidy (R-LA) released a white paperdetailing proposals to improve the National Institutes of Health (NIH). The document emphasizes the importance of NIH maintaining a balanced portfolio, so all stages of medical research and other public health priorities are adequately funded. The report also examined how the U.S. can sustain its advantage in biomedical research and lays out several proposals including streamlining peer review of research and addressing challenges in recruiting and maintaining the biomedical workforce.
On May 9, Sens. John Fetterman (D-PA) and Tina Smith (D-MA) released legislation to establish a bipartisan Senate mental health commission that would aim to address gaps in patient care and provider payment. The U.S. Senate Commission on Mental Health Actwould create an independent commission charged with investigating barriers to care delivery; crafting an annual report that reviews ongoing research; and making recommendations to congressional leaders and the White House.
REGULATORY UPDATE
On May 6, the Medicare Boards of Trustees released the annual Medicare Trustees Reports. The reports state the Medicare Hospital Insurance (HI) Trust Fund (Part A) will be solvent until 2036, five years later than reported last year. The Trustees attributed this change to higher payroll tax collections due to an improved job market and lower than expected hospital inpatient and home health spending. A fact sheet detailing the reports can be found here.
On May 6, the Centers for Medicare & Medicaid Services (CMS) released a statement on agent and broker marketplace activity. CMS stated that it is taking stronger actions givenconcerning activity by some agents and brokers related to unauthorized plan switches and unauthorized enrollments. CMS received approximately 40,000 complaints of unauthorized plan switches in the first three months of 2024 and approximately 39,000 of the complaints have been resolved.
On May 6, the Department of Health & Human Services (HHS) Office on Women’s Health announced the final phase winners for the HHS Hypertension Innovator Award Competition. The national competition was created to identify and reward innovative programs that ensure women with hypertension during pregnancy and/or postpartum receive appropriate monitoring and follow-up. A list of final phase winners can be found here.
On May 6, the Food & Drug Administration (FDA) announced a webinar that will be held on May 14 to discuss the final rule “Medical Devices; Laboratory Developed Tests” (LDTs). During the webinar, FDA will provide an overview of the final rule amending FDA’s regulations to make it explicit that in vitro diagnostic products (IVDs) are devices under the Federal Food, Drug, and Cosmetic Act including when the manufacturer of the IVD is a laboratory; and describe the phaseout of the FDA’s general enforcement discretion approach for LDTs.
On May 7, Lilly announced that FDA will convene an in-person meeting of the Peripheral and Central Nervous System Drugs Advisory Committee (PCNS) on June 10, 2024, to discuss donanemab, which Lilly has submitted for FDA approval for the treatment of early symptomatic Alzheimer’s disease. The open public hearing portion of the meeting will be conducted virtually.
On May 7, FDA’s Center for Biologics Evaluation and Research (CBER) announced that the May 16 meeting of the Vaccines and Related Biological Products Advisory Committee (VRBPAC) is being rescheduled to June 5, 2024. The meeting, at which the Committee will discuss and make recommendations on the selection of strain(s) to be included in the 2024-2025 formula for COVID-19 vaccines, is being moved to a later date to allow for additional time to obtain surveillance data and other information on recently circulating strains and to ensure that committee members will have more up-to-date information when making their recommendations.
On May 7, FDA announced a meeting of the Psychopharmacologic Drugs Advisory Committee on June 4 to discuss a new drug application for midomafetamine (MDMA) capsules, submitted by Lykos Therapeutics, for the treatment of post-traumatic stress disorder. The committee will discuss the overall benefit-risk profile of the product, including the potential public health impact.
On May 7, HHS’ Administration for Community Living (ACL) issued a final rule to establish the first federal regulations for Adult Protective Services (APS). The new regulations promote high quality APS and will improve consistency in services across states. With the final rule, ACL aims to support the national network that delivers APS, with the goal of better meeting the needs of adults who experience, or are at risk of, maltreatment and self-neglect.
On May 8, CMS issued a proposed rule announced the Increasing Organ Transplant Access (IOTA) Model. The proposed mandatory six-year model, which would be implemented by the Centers for Medicare and Medicaid Innovation, aims to increase access to kidney transplants for all people living with end-stage renal disease (ESRD), improve the quality of care for people seeking kidney transplants, reduce disparities among individuals undergoing the process to receive a kidney transplant, and increase the efficiency and capability of transplant hospitals selected to participate. Specifically, participating transplant hospitals would be measured by increases in the number of transplants, increased organ acceptance rates, and post-transplant outcomes. Additionally, the model would offer additional performance incentives to participating transplant hospitals to improve equity in the transplant process. CMS also proposed to codify standard provisions from the ESRD Treatment Choices (ETC) and Radiation Oncology (RO) models to apply to all models, as well as proposed new standard provisions regarding the reconsideration review process. Hospitals eligible for the proposed model are non-pediatric facilities that conduct at least 11 transplants each during a three-year baseline period. A fact sheet detailing the IOTA Model can be found here. Comments on the model are due on July 16.
On May 8, HHS announced that HHS’ Office of Inspector General (OIG) Office of Evaluation and Inspections (OEI) is conducting a study regarding the role of patient selection criteria in ensuring equitable access to kidney transplantation. As a part of this study, OIG is collecting data from Medicare-participating adult kidney transplant programs. In OIG’s first request for information, sent to transplant programs in April 2024, the Office requested that programs submit their written patient selection criteria and certain information regarding the population of patients evaluated for a deceased donor kidney transplant in calendar year 2023. OIG stated that it will contact some programs a second time for additional information regarding a sample of patients from this population.
On April 8, the Substance Abuse and Mental Health Services Administration (SAMHSA) announced $46.8 million in notices of funding opportunities to promote youth mental health, grow the behavioral health workforce, improve access to culturally competent behavioral care across the country, and strengthen peer recovery and recovery support. The funding opportunities invest in a range of behavioral health efforts including: $15.4 million for the Minority Fellowship Program; $14.9 million for the Cooperative Agreements for the Garrett Lee Smith State/Tribal Youth Suicide Prevention and Early Intervention Program; $9 million for the Addiction Technology Transfer Centers Cooperative Agreements; and $7.5 million for the National Center for Mental Health Dissemination, Implementation and Sustainment Cooperative Agreement.
On May 8, in response to President Biden’s Executive Order 14081, Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy, the Environmental Protection Agency (EPA), FDA, and Department of Agriculture (USDA) released a plan to update, streamline, and clarify their regulations and oversight mechanisms for products of biotechnology. The plan aims to ensure public confidence in the biotechnology regulatory system and improve its transparency, predictability, coordination, and efficiency. The agencies have identified five major areas of biotechnology product regulation where these actions will focus: modified plants; modified animals; modified microorganisms; human drugs, biologics, and medical devices; and cross-cutting issues.
On May 9, CMS’ Medicare-Medicaid Coordination Office announced a webinar entitled Improving Health Equity for Dually Eligible Enrollees in Rural Areas. The webinar will take place on May 21, 2024. Registration can be found here.
On May 9, CMS announced an extension of unwinding flexibilities to support state efforts to protect the continuity of coverage in Medicaid and the Children’s Health Insurance Program. States can continue to use certain waiver authorities to streamline eligibility redeterminations until June 30, 2025, adding a year to the previous deadline of June 2024.
On May 9, FDA issued final guidance to provide the medical device industry clarity on the definition of “remanufacturing” for reusable devices needing maintenance or repair. The final guidance seeks to ensure that there is consistency regarding what constitutes remanufacturing activities and to promote a better understanding of applicable federal law and regulations implicated by remanufacturing activities.
On May 9, FDA announced that it will hold its annual meeting to examine the financial transparency and efficiency of the Prescription Drug User Fee Act, Biosimilar User Fee Act, and Generic Drug User Fee Amendments on June 6. The agency will present five-year financial plans for the brand-name, biosimilar and generic drug user-fee programs.
On May 9, the Department of Justice (DOJ) announced the formation of the Antitrust Division’s Task Force on Health Care Monopolies and Collusion (HCMC). The HCMC will guide the division’s enforcement strategy and policy approach in health care, including by facilitating policy advocacy, investigations and, where warranted, civil and criminal enforcement in health care markets. The HCMC will be directed by Katrina Rouse, who previously served as Chief of the division’s Defense, Industrials and Aerospace Section, Assistant Chief of the Division’s San Francisco Office, a Special Assistant U.S. Attorney and a Trial Attorney in the division’s Healthcare and Consumer Products Section.
On May 10, HHS and the Department of Agriculture (USDA) announced assistance for producers with H5N1 affected premises to improve on-site biosecurity in order to reduce the spread. USDA is taking steps to make available financial tools for lost milk production in herds affected by H5N1. Among other actions, USDA will provide: financial support (up to $2,000 per affected premises per month) for producers who supply PPE to employees and/or provide outerwear uniform laundering; support (up to $1,500 per affected premises) to develop biosecurity plans based on existing secure milk supply plans; and funding for heat treatment to dispose of milk in a bio secure fashion.
White House
On May 6, the White House Office of Science and Technology Policy released a new policyfor oversight of dual use research of concern and pathogens with enhanced pandemic potential. The policy addresses oversight of research on biological agents and toxins that, when enhanced, have the potential to pose risks to public health, agriculture, food security, economic security, or national security. Researchers who seek federal funding to conduct research on these types of pathogens must submit a risk-mitigation plan to the agency funding the work. The agency will weigh the benefits and risks to decide whether to fund the project and a panel of scientific experts will review the research plan before it’s approved. Implementation guidance can be found here.
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
FDA
Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies; Guidance for Industry; Notice; 4/10/24
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 May 8, GAO released a report examining Medicare Hospice and the need for CMS to fully implement statutory provisions from the Consolidated Appropriations Act, 2021 related to hospice oversight. GAO found that about 15% of hospices that had at least one standard survey in each three year reporting cycle between 2017 and 2022 were cited with serious quality deficiencies, and most were cited with multiple such deficiencies. CMS policy requires that these hospices undergo additional monitoring and face termination from the Medicare program without timely resolution; according to CMS officials, 18 hospices were terminated between 2017 and 2022. Additionally, GAO found that as of May 2023, about 10% of hospices participating in Medicare for 36 months or more were overdue for a survey, and of the hospices with overdue surveys, over one quarter had not had a standard survey in at least 5 years. GAO made four recommendations to CMS, including that the agency fully implement the remaining three CAA provisions, and prioritize completion of standard surveys for those hospices that are overdue based on potential risk factors. HHS agreed with three recommendations but disagreed with prioritizing survey completion based on risk factors.
Office of Inspector General (OIG)
On May 10, OIG released a report examining potential vulnerabilities in CMS oversight of Medicare add-on payments for COVID-19 tests. Based on OIG’s analysis of $339.4 million in Medicare add-on payments made to 9,380 laboratories for COVID-19 diagnostic tests provided to more than 4 million enrollees during the audit period, OIG determined that more than two-thirds of laboratories that billed Medicare at least once for the add-on payment during the audit period billed for that payment with all of their COVID-19 tests. OIG also identified the following potential vulnerabilities related to CMS and the Medicare Administrative Contractors’ (MACs’) oversight of add-on payments for COVID-19 tests: 1) CMS requirements related to supporting documentation for add-on payments were vague, and documentation from the laboratories was inconsistent; and 2) CMS and the MACs did not perform adequate reviews of claims for add-on payments. OIG stated that the office believes that it is important for CMS and MACs to provide oversight of add-on payments to prevent fraud, waste, and abuse in the Medicare program
House
Education & Workforce Committee
May 15; 10:15 AM; 2175 Rayburn
Examining the Policies and Priorities of the Department of Health & Human Services
Witness: HHS Secretary Xavier Becerra
Energy & Commerce Committee
Health Subcommittee
May 22; 10:00 AM; 2322 Rayburn
Check Up: Examining FDA Regulation of Drugs, Biologics, and Devices
Witnesses: Patrizia Cavazzoni, M.D., Director, Center for Drug Evaluation and Research (CDER), FDA; Peter Marks, M.D., Director, Center for Biologics Evaluation and Research (CBER), FDA; Jeffrey Shuren, M.D., Director, Center for Devices and Radiological Health (CDRH), FDA
Week of May 20
Expected markup of telehealth legislation
UPCOMING HEARINGS
Senate
HELP Committee
May 16; 10:00 AM; SD-430
Examining the Dental Care Crisis in America: How Can We Make Dental Care More Affordable and More Available?
Finance Committee
May 10; 10:00 AM; 215 Dirksen
Rural Health Care: Supporting Lives and Improving Communities
Witnesses: Keith Mueller, Gerhard Hartman Professor of Health Management and Policy and Director, Rural Policy Research Institute (RUPRI); Lori Rodefeld, MS, Director of GME Development, Wisconsin Collaborative for Rural Graduate Medical Education (WCRGME); Michael Topchik, Executive Director, Chartis Center for Rural Health; Jeremy P. Davis, MHA, President and Chief Executive Officer, Grande Ronde Hospital
May 23
Expected hearing on fentanyl and expanding access to treatment
OTHER POLICY NEWS
On May 6, the American Journal of Preventive Medicine published research finding that HHS’ COVID-19 Vaccination Public Education Campaign, We Can Do This, resulted in an estimated $731.9 billion in societal benefits due to averted illness and related costs, resulting in a nearly $90 return in societal benefits for every $1 spent.