Health Care Watch: May 20, 2024
The following Federal Health Policy (FHP) Strategies Weekly Health Care Watch provides a summary of legislative and regulatory health care activities from May 12 – May 18. 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 14, Oversight and Accountability Committee Chairman James Comer (R-KY) and Health Care and Financial Services Subcommittee Chairwoman Lisa McClain (R-MI) sent a letter to Drug Enforcement Administration (DEA) Administrator Anne Milgram regarding further investigation into the growing number of critical drug shortages. The letter requests documents and communications related to DEA’s impact on and response to the prolonged shortages of Schedule II drugs, including Adderall.
On May 15, the Oversight and Accountability Committee voted, 40-1, to advance the BIOSECURE Act. The legislation would prohibit the federal government from contracting with companies that have used products or services from companies of concern which the legislation lists as BGI, MGI, Complete Genomics, WuXi AppTec and WuXi Biologics.
On May 16, the Energy & Commerce Health Subcommittee voted unanimously to advance legislation that would extend eased telehealth rules in the Medicare program for two more years, extend hospital-at-home waivers for five years, and use pharmacy benefit manager (PBM) reform as a pay-for. The legislation is largely in line with a bill that the Ways and Means Committee advanced unanimously last week. Key differences between the bills are that the Energy & Commerce Committee’s bill would: establish payment parity for federally qualified health centers and rural health clinics for in-person and virtual care, require a modifier for billing for telehealth offered via a “telehealth virtual platform” and nonphysician providers, and establish a broader Part D policy delinking PBM compensation from list prices and utilization levels. The E&C bill also does not include the Medicare hospice offset.
Senate
On May 14, Health, Education, Labor & Pensions (HELP) Committee Ranking Member Bill Cassidy (R-LA) sent a letter to UnitedHealth Group (UHG) CEO Andrew Witty requesting more information from UHG on why it did not implement multifactor authentication or other agency recommendations that could have prevented the cybersecurity attack on Change Healthcare. The letter also requests information on how UHG is working with providers and other stakeholders to ensure all services are back online and patient care is not further impacted.
On May 14, Finance Committee Chairman Ron Wyden (D-OR) and Sens. Tammy Duckworth (D-IL) and Mazie Hirono (D-HI) sent a letter to Senate Appropriations Subcommittee on Labor, Health and Human Services, Education and Related Agencies leadership asking that the Committee provide increased funding–at least $32 million–for the U.S. Public Health Service Commissioned Corps (PHS) in FY 2025 to ensure that frontline workers are always ready and fully-deployable to protect the health, safety, and welfare.
On May 15, the Bipartisan Senate Artificial Intelligence (AI) Working Group, led by Majority Leader Chuck Schumer (D-NY), released new guidance detailing a roadmap for artificial intelligence (AI) policy. The guidance discusses high-risk AI, guardrails for legislators, Centers for Medicare & Medicaid Services (CMS) payment methods for AI, and continued AI research.
On May 17, Finance Committee Chairman Wyden and Ranking Member Mike Crapo (R-ID) released a white paper outlining policy concepts related to reforming the way physicians are paid by Medicare and treating chronic illness. The white paper outlines a number of areas of interest including: creating sustainable payment updates to ensure clinicians can own and operate their practices; incentivizing alternative payment models that reward providing better care at a lower cost; rethinking how Medicare measures quality care; improving primary care; supporting chronic care benefits in Medicare fee-for-service; and ensuring continued access to telehealth.
REGULATORY UPDATE
On May 13, Department of Health & Human Services’ (HHS’) Office of the National Coordinator for Health Information Technology (ONC) published a Special Emphasis Notice (SEN) under the Leading EdgeAcceleration Projects (LEAP) in Health Information Technology (Health IT) funding opportunity for fiscal year 2024. Specifically, ONC is seeking applications through this funding opportunity for projects that address one of the following areas of interests: 1) development of innovative ways to evaluate and improve the quality of health care data used by AI tools in health care; and 2) the acceleration of adoption of health IT in behavioral health.
On May 13, HHS announced that an investigation by HHS’ Office for Civil Rights (OCR) and the United States Attorney’s Office for the District of Rhode Island found that the State of Rhode Island violated federal civil rights laws by routinely and unnecessarily segregating children with mental health and/or developmental disabilities at Bradley Hospital, an acute-care psychiatric hospital. The federal government’s investigation resulted in a finding that the State left children in Rhode Island Department of Children, Youth and Families (DCYF) care hospitalized at Bradley for far longer than necessary. All findings from the investigation can be found here.
On May 13, the Food & Drug Administration (FDA) announced the virtual Medical Device Sterilization Town Hall: Sterilization Method Selection for New and Existing Devices. The town hall will be held on May 23, 2024, from 1:00-2:15 PM ET. During the town hall, FDA will host a panel discussion for what to consider when choosing a sterilization method or changing methods.
On May 14, HHS announced the release of the National Strategy to Improve Maternal Mental Health Care. The strategy includes recommendations developed by the Task Force on Maternal Mental Health to address the urgent public health crisis of maternal mental health and substance use issues. The national strategy calls for integration of perinatal mental health and substance use care across medical, community, and social systems that increases equity and access, improves federal coordination, and elevates culturally relevant supports. The five pillars of the national strategy focus on: 1) building a national infrastructure that prioritizes perinatal mental health and well-being; 2) making care and services accessible, affordable, and equitable; 3) using data and research to improve outcomes and accountability; 4) promoting prevention and engaging, educating, and partnering with communities; and 5) lifting up the voices of people with lived experience.
On May 15, CMS released the 2024 Quality Measure Development Plan (MDP) Annual Report, which describes progress in developing clinician quality measures to support the Quality Payment Program (QPP). The 2024 report records fiscal year (FY) 2023 expenditures of $1.1 million for measure development funded by title XVIII of the Act, including $161,077 to complete Adult COVID-19 Vaccination Status.
On May 15, CMS provided an update on work related to the Misclassification of Drugs, Program Administration and Program Integrity Updates Under the Medicaid Drug Rebate Program proposed rule. As part of the proposed rule, CMS proposed revisions to the regulations for the determination of best price at § 447.505(d)(3) to make clearer that the manufacturer must adjust the best price for a drug for a rebate period if cumulative discounts, rebates, or other arrangements to best price eligible entities subsequently adjust the prices available from the manufacturer, and that those discounts, rebates, or other arrangements must be “stacked” for a single transaction to determine a final price realized by the manufacturer for a drug. CMS received comments both supporting and opposing the proposed revisions to § 447.505(d)(3). CMS stated that while they are still working on finalizing other proposals in the rule, they wanted to convey that they are not finalizing the proposal regarding “stacking” at this time. Instead, CMS is going to pursue the collection of additional information from manufacturers related to best price stacking methodologies to better understand and inform future rulemaking.
On May 15, HHS announced that it has suspended federal grants issued to EcoHealth Alliance, the infectious disease research group caught up in a controversy over its work in China, and plans to bar it from receiving future funding. HHS’ decision comes two weeks after House lawmakers grilled EcoHealth President Peter Daszak on the nonprofit’s research, oversight, and safety measures, particularly its work with the Wuhan Institute of Virology, and contentious infectious disease studies.
On May 15, the Department of Justice (DOJ) announced that the Attorney General has submitted to the Federal Register a notice of proposed rulemaking initiating a formal rulemaking process to consider moving marijuana from a schedule I to schedule III drug under the Controlled Substances Act (CSA).
On May 16, HHS’ Administration for Children and Families (ACF) announced new policy guidance and resources for states, Tribes, territories and local early childhood programs to promote the mental health and wellness of children, families and the early care and education workforce. The new resources are tailored to recipients of ACF’s four early childhood funding streams—the Child Care and Development Fund, the Head Start program, the Preschool Development Grants Birth through Five program and the Tribal Home Visiting Program – and provide a range of actionable recommendations, resources, and strategies to promote healthy child development and to integrate mental and behavioral health supports into early care and education programs.
WHITE HOUSE
On May 14, President Joe Biden announced the implementation of tariffs on a variety of imports from China, including medical products. Tariffs on medical products include a 50% tax on Chinese-made syringes and needles, a 25% tariff on certain imported personal protective equipment, including some respirators and face masks, and a 25% tax on Chinese-manufactured rubber medical and surgical gloves.
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
Platform Technology Designation Program; Draft Guidance for Industry; Availability; Agency Information Collection Activities; Proposed Collection; Comment Request (CDER, 2024-87); Notice; 5/13/24
ONC
Health Data, Technology, and Interoperability: Patient Engagement, Information Sharing, and Public Health Interoperability; Proposed Rule; 1/18/24
REPORTS
Office of Inspector General (OIG)
On May 13, OIG released a report examining New Mexico’s Medicaid nursing facility level-of-care managed care capitated payments. OIG found that New Mexico performed reconciliations of capitated payments for community benefit (CB) services as required under its contracts with managed care organizations (MCOs). OIG found that of the $3.8 billion in CB services capitated payments for the audit period, New Mexico did not recoup $139.2 million in overpayments for enrollees who did not use CB services within 90 calendar days of their approval for CB services. As a result, New Mexico did not return the related Federal share of $98.6 million. OIG recommends that New Mexico: 1) recoup $139.2 million in CB services capitated payments from its MCOs and refund the $98.6 million in Federal share to the Federal Government; 2) recoup the $29.4 million in nursing facility level-of-care (NFLOC) capitated payments from its MCOs and refund the $20.5 million Federal share to the Federal Government; and 3) establish policies and procedures to recoup the NFLOC capitated payments made to its MCOs based on settings-of-care that are removed after payment and no longer valid.
Government Accountability Office (GAO)
On May 17, GAO released a report examining the activities of the national mental health and substance use policy laboratory. GAO found that the Policy Lab performs activities that generally align with its statutory responsibilities. Policy Lab activities include the following: 1) facilitating SAMHSA's implementation of policy changes from multiple sources such as the White House, Congress, and HHS, including SAMHSA leadership; 2) coordinating cross-SAMHSA and inter-agency policy efforts and promoting coordination and collaboration of SAMHSA programs; 3) facilitating communication between SAMHSA's training and technical assistance providers; 4) reviewing budget formulation and funding announcements to identify and develop recommendations to address SAMHSA programs that are potentially duplicative or not evidence-based or effective; and 5) working with SAMHSA's Center for Behavioral Health Statistics and Quality to collect, evaluate, and disseminate information on evidence-based practices in consultation with other agencies and experts.
UPCOMING HEARINGS
House
Energy and Commerce Committee
Health Subcommittee
May 22; 10:00 AM; 2322 Rayburn
Check Up: Examining FDA Regulation of Drugs, Biologics, and Devices
Witnesses: Patrizia Cavazzoni, MD, Director, Center for Drug Evaluation and Research (CDER), FDA; Peter Marks, MD, Director, Center for Biologics Evaluation and Research (CBER), FDA; Jeffrey Shuren, MD, Director, Center for Devices and Radiological Health (CDRH), FDA
Ways and Means Committee
Subcommittee on Health
May 23; 9:00 AM; 1100 Longworth
Hearing on The Collapse of Private Practice: Examining the Challenges Facing Independent Medicine
Senate
Judiciary Committee
May 21; 10:00 AM; G50 Dirksen
Ensuring Affordable & Accessible Medications: Examining Competition in the Prescription Drug Market
Witnesses: William Feldman, MD, Associate Physician, Division of Pulmonary and Critical Care Medicine, Brigham and Women’s Hospital; David Mitchell, President and Founder, Patients for Affordable Drugs; Adam Mossof, Professor of Law, George Mason University; Arti Rai, Professor of Law, Duke University; and Jocelyn Ulrich, VP, Policy and Research, PhRMA
Budget Committee
May 23; 10:00 AM; 210 Cannon
Breaking Up Health Care Monopolies: Examining the Budgetary Effects of Health Care Consolidation
Witnesses: Chapin White, Director of Health Analysis, Congressional Budget Office; Benedic Ippolito, Senior Fellow in Economic Policy Studies, American Enterprise Institute; Adam Bruggeman, MD, Texas Spine Care Center
Finance Committee
May 23; 10:00 AM
Front Lines of the Fentanyl Crisis: Supporting Communities and Combating Addiction through Prevention and Treatment
Witnesses: Tony Vezina, Executive Director, 4th Dimension Recovery Center; Jeanmarie Perrone, MD, Director, Center for Addiction Medicine and Policy, University of Pennsylvania; Caleb Banta-Green, Research Professor, University of Washington School of Medicine; Abigail Herron, DO, Vice President And Chief Behavioral Health Officer, The Institute for Family Health
Appropriations Committee
Subcommittee on Labor, Health and Human Services, Education, and Related Agencies
May 23; 10:00 AM; 124 Dirksen
A Review of the President’s Fiscal Year 2025 Budget Request for the National Institutes of Health
Witnesses: Monica Bertagnolli, MD, Director, National Institutes of Health; Kimryn Rathmell, MD, Director, National Cancer Institute; Jeanne Marrazzo, MD, Director, National Institute of Allergy and Infectious Diseases; Nora Volkow, MD, Director, National Institute on Drug Abuse; Richard Hodes, MD, Director, National Institute on Aging; Gary Gibbons, MD, Director, National Heart, Lung, and Blood Institute
HELP Committee
May 23; 10:00 AM; SD-430
S. 3679, S. 3765, S. 4351, S. 3775, S. 4325, S. 3757, S. 4045, and Nomination
Legislation to be considered:
S. 3679, Dr. Lorna Breen Health Care Provider Protection Reauthorization Act
S. 3765, Emergency Medical Services for Children Reauthorization Act of 2024
S. 4351, A bill to amend the Public Health Service Act to reauthorize certain poison control programs.
S. 3775, BOLD Infrastructure for Alzheimer's Reauthorization Act of 2024
S. 4325, A bill to amend the Public Health Service Act to reauthorize the program relating to lifespan respite care, and for other purposes.
S. 3757, Congenital Heart Futures Reauthorization Act of 2024
S. 4045, East Palestine Health Impact Monitoring Act of 2024