Health Care Watch: March 17, 2024
The following Federal Health Policy (FHP) Strategies Weekly Health Care Watch provides a summary of legislative and regulatory health care activities from March 10 – March 17. 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 March 12, the Energy & Commerce Committee held a markup of 19 health policy-related bills. Most of the legislation received unanimous bipartisan support aside from H.R. 5074, Kidney PATIENT Act and H.R. 5526, Seniors’ Access to Critical Medications Act of 2023 facing some opposition from committee Democrats. However, both pieces of legislation advanced with votes of 16-10 and 19-6, respectively.
On March 12, it was announced that Rep. John James (R-MI) will assume the open seat on the Energy & Commerce Committee following former Rep. Bill Johnson’s (R-OH) departure.
On March 12, Rep. Ken Buck (R-CO) announced that he will leave Congress at the end of next week, leaving House Republicans with 218 members and the Democrats 213 seats.
During the week of March 18, two special elections will be held: California’s special primary election to fill former House Speaker Kevin McCarthy’s seat and Ohio’s special election to fill former Rep. Johnson's seat.
Senate
On March 12, Finance Committee Chairman Ron Wyden (D-OR) and Health, Education, Labor and Pension (HELP) Committee Chairman Bernie Sanders (I-VT) sent a letter to Secretaries of the Departments of Health & Human Services (HHS), Treasury, and Labor requesting that they issue guidance to insurers to crack down on cost-sharing practices that result in surprise medical billing to patients.
On March 13, HELP Committee Ranking Member Bill Cassidy (R- LA) issued a request for information (RFI) from stakeholders on ways to improve regulation of clinical tests in the United States. Ranking Member Cassidy states that he hopes to use the feedback on how Congress can modernize current regulations to support innovation while ensuring that clinical tests are safe and effective to use. Feedback is due on April 3, 2024.
On March 14, Finance Committee Chairman Wyden and Ranking Member Mike Crapo (R-ID) sent a letter to their Finance Committee colleagues reaffirming their commitment to passing their pharmacy benefit manager (PBM) reform legislation as soon as possible during this Congress. The letter was sent ahead of a press conference where the Senators were joined by PBM reform advocates.
On March 14, HELP Committee Ranking Member Cassidy and Sen. Tom Carper (D-DE) led a group of bipartisan senators in the rollout of legislation aimed at improving coordination of coverage for dual-eligible beneficiaries. TheDUALS Act of 2024 would require each state, with assistance from the Centers for Medicare & Medicaid Services (CMS), to develop and implement an integrated health plan tailored to dual-eligible beneficiaries. The bill would also establish a care coordinator for each enrollee, reduce look alike plans, and create a single appeals process for both programs.
REGULATORY UPDATE
On March 9, CMS announced that it continues to monitor and assess the impact that the cyberattack on UnitedHealth Group’s subsidiary Change Healthcare has had on all provider and supplier types. CMS stated that in addition to considering applications for accelerated payments for Medicare Part A providers, it will also be considering applications for advance payments for Part B suppliers.
On March 10, HHS sent a letter to health care leaders stating that the agency is urging UnitedHealth Group to take responsibility for the impact of the recent cyberattack that has delayed provider payments. In the letter, HHS Secretary Xavier Becerra called on UnitedHealth Group to ensure expedited delivery of funds to providers, communicate more frequently, and provide Medicaid agencies with a list of impacted providers. He also asks that insurers make interim payments to providers, particularly Medicaid providers.
On March 11, HHS Secretary Becerra released a statement on President Biden’s fiscal year (FY) 2025 budget. Secretary Becerra stated that the budget lays out a vision for a nation that invests in all aspects of health, fosters innovation, and supports its most vulnerable and continues the nation’s shift from one that focused on illness to one that promotes wellness.
On March 11, HHS released a fact sheet detailing the provisions included in President Biden’s FY 2025 budget aimed at lowering prescription drug costs. Proposed actions include letting Medicare “negotiate” prices for more drugs, expanding the cap on out-of-pocket prescription drug costs, lowering cost-sharing for high-value generic drugs in Medicare, and expanding the Inflation Reduction Act’s requirement that drug companies pay rebates when they increase prices faster than inflation to commercial sales. Additional HHS budget documents can be found here.
On March 11, the Food & Drug Administration (FDA) announced that it is requesting $7.2 billion as part of President Biden’s FY 2025 proposed budget. FDA stated that the funding will allow the agency to enhance food safety and nutrition, advance medical product safety, help support supply chain resiliency, strengthen the agency’s public-health and mission-support capacity, and modernize the FDA’s infrastructure and facilities. The request includes an increase of $495 million—or 7.4% above the FY 2023 funding level.
On March 12, the Eighth Circuit Court of Appeals upheld an Arkansas law prohibiting drugmakers from restricting 340B drug discounts for providers using contract pharmacies. The court’s three judge panel disagreed with Pharmaceutical Research and Manufacturers of America’s (PhRMA) argument that Arkansas’ 340B Drug Pricing Nondiscrimination Act passed in 2021 is preempted by existing federal law outlining the program, which requires drug manufacturers to sell drugs at a discount to safety-net providers.
On March 12, FDA issued draft guidance entitled Select Updates for the Premarket Cybersecurity Guidance: Section 524B of the FD&C Act. The draft guidance proposes updated recommendations to industry on quality system considerations for cyber devices and for documentation in device premarket submissions.
On March 12, HHS Secretary Becerra and Deputy Secretary Andrea Palm, led a convening of health care community leaders – joined by White House Domestic Policy Advisor Neera Tanden, White House Deputy National Security Advisor (DNSA) for Cyber and Emerging Technologies Anne Neuberger, and others from the federal government – to discuss concrete actions to mitigate harms to patients and providers caused by the cyberattack on Change Healthcare. Secretary Becerra and Domestic Policy Advisor Tanden made clear the government and private sector must work together to help providers make payroll and deliver timely care. Biden Administration officials directly heard concerns from representatives of provider groups including hospitals, children’s health providers, physicians, infusion centers, pharmacies, community health centers, and long-term care facilities.
On March 12, CMS released a readout of CMS Administrator Chiquita Brooks-LaSure's participation in a roundtable with senior Administration leaders to hear from health care providers about the challenges they are experiencing following the cyberattack on Change Healthcare, and to urge health insurers to do more to support affected providers and suppliers. At the roundtable, CMS announced that guidance to states is forthcoming that will provide needed flexibilities to allow states to support Medicaid providers and suppliers, particularly those operating in fee-for-service delivery systems.
On March 13, CMS released a fact sheet detailing frequently asked questions regarding the Change Healthcare/ Optum Payment Disruption (CHOPD) accelerated and advance payments for Part A providers and Part B suppliers.
On March 13, HHS’ Office for Civil Rights (OCR) issued a Dear Colleague letter addressing the cybersecurity incident impacting Change Healthcare and many other health care entities. The letter states that OCR is initiating an investigation into the incident and will focus on whether a breach of protected health information occurred and on Change Healthcare’s and United HealthGroup’s compliance with Health Insurance Portability and Accountability Act(HIPAA) Rules.
On March 13, HHS released a fact sheet detailing in-vitro fertilization (IVF) use across the country. The fact sheet details infertility rates, causes and risk factors, treatment options, and health outcomes for individuals who have used or who are interested in using IVF technologies.
On March 14, FDA approved Rezdiffra (resmetirom) for the treatment of adults with noncirrhotic non-alcoholic steatohepatitis (NASH) with moderate to advanced liver scarring (fibrosis), to be used along with diet and exercise.
On March 15, CMS announced that it will host a webinar entitled Quality Counts, Safety Matters: Prioritizing Patient Safety Through Quality Measurement. The webinar will take place on March 21 at 2:00 PM ET. Registration can be found here.
On March 15, the FDA’s Oncologic Drugs Advisory Committee (ODAC) voted to recommend that the FDA agency allow patients with multiple myeloma to access two chimeric antigen receptor T-cell (CAR-T) therapies earlier in the course of disease progression, despite FDA scientists’ concerns about the treatments potentially contributing to early deaths. The two CAR-T therapies are: Legend Biotech and Johnson & Johnson’s CARVYKTI and Bristol Myers Squibb’s ABECMA. ODAC’s voting members unanimously voted to recommend FDA approve the Carvykti for patients earlier in the course of myeloma disease progression and voted 8-3 to recommend the same for ABECMA.
White House
On March 11, President Biden released his FY 2025 budget. The budget asks for $130.7 billion for HHS, a $2.2 billion increase from 2023. Accompanying the budget, the Administration released the HHS Budget in Brief, which provides additional details on health proposals including: expanding the number of drugs subject to Medicare price negotiations from 20 to 50 a year, extending the $2,000 out-of-pocket prescription drug spending cap that’s set to take effect for Medicare beneficiaries next year to commercial insurance plans, and extending the $35 insulin cap to the commercial market. Additionally, the budget proposes $125 million in funding to aid states in enforcing mental health parity requirements and includes provisions that provide Medicaid-like coverage to individuals in the 10 states that have yet to expand coverage.
On March 13, President Biden announced the White House Challenge to Save Lives from Overdose. The Challengeis a nationwide call-to-action to stakeholders across all sectors to save lives by committing to increase training on and access to lifesaving opioid overdose reversal medications. Organizations may make a commitment here.
On March 13, Assistant to the President and Director of the Gender Policy Council Jennifer Klein and Senior Advisor and Assistant to the President and Director of the White House Office of Intergovernmental Affairs Tom Perez convened legislative leaders to discuss their efforts to protect access to fertility care across the country. Legislators discussed strategies to combat legislation restricting reproductive freedom, including access to IVF and other fertility services, and also discussed efforts to improve access to fertility care, including through comprehensive insurance coverage.
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
Streamlining the Medicaid, CHIP, and BHP Application, Eligibility Determination, Enrollment, and Renewal Processes (CMS-2421); Final Rule’ 12/19/23
Medicaid and Children's Health Insurance Program (CHIP) Managed Care Access, Finance, and Quality (CMS-2439); Final Rule; 12/20/23
Ensuring Access to Medicaid Services (CMS-2442); Final Rule; 1/26/24
Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals; the Long-Term Care Hospital Prospective Payment System; and FY 2025 Rates (CMS-1808); Proposed Rule; 1/31/24
HHS Notice of Benefit and Payment Parameters for 2025 (CMS-9895); Final Rule; 2/15/24
FY 2025 Hospice Wage Index, Payment Rate Update, and Quality Reporting Requirements (CMS-1810); Proposed Rule; 2/16/24
Short-Term, Limited-Duration Insurance; Independent, Noncoordinated Excepted Benefits Coverage; and Tax Treatment of Certain Accident and Health Insurance (CMS-9904); Final Rule; 2/22/24
Contract Year 2025 Policy and Technical Changes to the Medicare Advantage, Medicare Prescription Drug Benefit, and Medicare Cost Plan Programs, and PACE (CMS-4205); Final Rule; 2/22/24
FY 2025 Inpatient Psychiatric Facilities Prospective Payment System Rate and Quality Reporting Updates (CMS-1806); Proposed Rule; 2/28/24
Minimum Staffing Standards for Long-Term Care Facilities and Medicaid Institutional Payment Transparency Reporting (CMS-3442); Final Rule; 3/1/24
FY 2025 Inpatient Rehabilitation Facility (IRF) Prospective Payment System Rate Update and Quality Reporting Program (CMS-1804); Proposed Rule; 3/4/24
FY 2025 Skilled Nursing Facility (SNFs) Prospective Payment System and Consolidated Billing and Updates to the Value-Based Purchasing and Quality Reporting Programs (CMS-1802); Proposed Rule; 3/5/24
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
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
Office of Inspector General (OIG)
On March 14, OIG released the Medicaid Fraud Control Units FY 2023 Annual Report. The report states that there were 1,143 convictions, 850 individuals or entities excluded from federal funded programs, 436 civil settlements and judgements, and $1.2 billion recovered. The full report can be found here.
Government Accountability Office (GAO)
On March 14, GAO released a report examining the need for additional federal action to fully leverage new appeals and grievances in Medicaid managed care. GAO found that data from state annual managed care reports indicated that rates of appeals and grievances per 1,000 enrollees varied widely across states in 2022, signaling a potential problem with access to needed services. GAO made two recommendations to CMS: 1) to require states to report on appeal outcomes and number of denials; and 2) to implement planned actions for analyzing, using, and publicly posting the appeals and grievances data.
UPCOMING HEARINGS
House
Appropriations Committee
March 20; 10:00 AM; 5358-C Rayburn
Fiscal Year 2025 Budget Request for the Department of Health &Human Services
Witnesses: HHS Secretary Becerra
Ways and Means Committee
March 18; 2:00 PM CST; Denton, TX
Field Hearing on Access to Health Care in America: Ensuring Resilient Emergency Medical Care
Witnesses: Chloe Burke. Emergency Care Patient; Edward Racht, M.D., Chief Medical Officer, Global Medical Response; Matt Zavadsky, Chief Transformation Officer, Medstar Mobile Healthcare; Ted Matthews; CEO, Anson General Hospital; Robert Morris, CEO, Complete Care; Lauren Miller, Emergency Care Patient.
March 20; 2:00 PM; 1100 Longworth
Hearing with Health & Human Services Secretary Becerra on President Biden’s FY25 HHS Budget Request
Witness: HHS Secretary Becerra
Energy and Commerce Committee
Health Subcommittee
March 21; 10:00 AM; 2123 Rayburn
Evaluating Approaches to Diagnostic Test Regulation and the Impact of FDA’s Proposed Rule
Witnesses: Susan Van Meter, President, American Clinical Laboratory Association; Zach Rothstein, Executive Director, AdvaMedDx; Donald Karcher, MD, President of the College of American Pathologists; Jeff Allen, President and CEO, Friends of Cancer Research; Dara Aisner, MD, Medical Director, Colorado Molecular Correlates Laboratory, Professor of Pathology, University of Colorado; Representative of the Academic Coalition for Effective Laboratory Developed Tests
Senate
Judiciary Committee
March 20; 2:30 PM; G50 Dirksen
The Continued Assault on Reproductive Freedoms in a Post-Dobbs America
Finance Committee
March 21; 10:00 AM; 215 Dirksen
Hearing on the President’s Fiscal Year 2025 Budget
Witnesses: Department of Treasury Secretary Janet Yellen
OTHER POLICY NEWS
On March 12, Bluebird Bio announced that it signed its first outcome-based payment agreement with a public payer, Michigan’s Medicaid program, for its sickle cell gene therapy, LYFGENIA.
On March 13, the Biotechnology Innovation Organization (BIO) announced that it is cutting ties with the Chinese-owned biologics company Wuxi Apptec and committed to support the BIOSECURE Act, legislation that would ban federal agencies from contracting or procuring equipment or services from biotechnology companies of concern, including any company that “is subject to the jurisdiction, direction, control, or operates on behalf of the government of a foreign adversary” and poses a biotechnology security concern. BIO became a target of the House Select Committee on the Chinese Communist Party over a letter it sent in February expressing concern over the BIOSECURE Act.
On March 15, the Medicare Payment Advisory Commission (MedPAC) released the March 2024 report to Congress on Medicare payment policy. The 2024 report considers the context of the Medicare program, including the near-term consequences of the end of the coronavirus public health emergency (PHE) and higher-than-usual inflation, and the longer-term effects of program spending on the federal budget and the program’s financial sustainability. The report makes recommendations for how payments should be updated in 2025 for Medicare fee-for-service (FFS) payment systems and satisfies two congressional mandates: one to review special needs plans for beneficiaries dually eligible for Medicare and Medicaid and another on a new provider designation, rural emergency hospitals. The full report can be found here.