Health Care Watch: November 18, 2024
The following Federal Health Policy (FHP) Strategies Weekly Health Care Watch provides a summary of legislative and regulatory health care activities from November 10 – November 16. 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 November 12, a group of Energy & Commerce Republicans, led by Committee Chair Cathy McMorris Rodgers (R-WA), sent a letter to Government Accountability Office (GAO) Comptroller General Gene Dodaro requesting an examination of the structure of laboratory safety programs at the Centers for Disease Control and Prevention (CDC), the Food & Drug Administration (FDA), and the National Institutes of Health (NIH). The letter states concern regarding the effectiveness of the oversight the Department of Health & Human Services (HHS) and its agencies provide to the laboratories they own and operate.
On November 12, House Republicans voted unanimously to nominate Speaker Mike Johnson (R-LA) to serve as the Speaker-elect for the 119th Congress. In addition to the internal vote, he must also win a formal vote on the House floor in January 2025.
On November 13, Republicans officially won control of the House, resulting in Republican control of both chambers and the White House.
On November 14, the GOP Doctors Caucus elected Rep. John Joyce (R-PA) to join Rep. Greg Murphy (R-NC) as co-chair of the caucus.
Senate
On November 13, Sen. John Thune (R-SD) won the three-way election, against Sens. John Cornyn (R-TX) and Rick Scott (R-FL), to serve as Senate Majority Leader in the 119th Congress.
On November 14, it was announced that Sen. Bill Cassidy (R-LA) will become Chairman of the Health, Education, Labor & Pensions (HELP) Committee in the 119th Congress.
REGULATORY UPDATE
On November 8, the Centers for Medicare & Medicaid Services (CMS) released the 2025 premiums, deductibles, and coinsurance amounts for the Medicare Part A and Part B programs, and the 2025 Medicare Part D income-related monthly adjustment amounts. CMS announced that the standard monthly premium for Medicare Part B enrollees will be $185 for 2025, an increase of $10.30 from 2024 and the annual deductible for all Medicare Part B beneficiaries will be $257 in 2025, an increase of $17 from 2024. The Medicare Part A inpatient hospital deductible that beneficiaries pay if admitted to the hospital will be $1,676 in 2025, an increase of $44 from 2024.
On November 12, CMS published Re-imagining Rural Health: Themes, Concepts, and Next Steps from the CMS Innovation Center “Hackathon” Series. The report describes lessons learned from previous Innovation Center models focused on rural health and their application to recent model development, as well as potential areas the Innovation Center might explore to support rural communities. The top thematic areas highlighted a need for training, regulatory changes, and collaboration to help improve access to care and support transformation. The paper also outlines possible considerations for future Accountable Care Organization-focused and other models.
On November 12, FDA announced that it has removed the clinical hold on Novavax's Investigational New Drug (IND) application for its COVID-19-Influenza Combination and stand-alone influenza vaccine candidates. FDA has cleared the company to begin enrolling the planned Phase 3 trial following the determination that Novavax satisfactorily addressed all clinical hold issues.
On November 12, the Department of Justice (DOJ) and four Democratic state attorneys general filed an antitrust lawsuit seeking to block UnitedHealth Group’s proposed $3.3 billion acquisition of Amedisys Inc., a major home health and hospice provider. The lawsuit alleges that the merger would stifle competition in the home health, hospice and labor markets, potentially limiting affordable care options for patients and reducing employment choices for nurses.
On November 12, Johnson & Johnson filed a lawsuit against the Biden Administration for prohibiting the drugmaker from charging certain hospitals participating in the 340B drug discount program full price for two drugs, Stelara and Xarelto, before applying drug rebates. Manufacturers participating in the 340B program provide up-front discounts to eligible providers. Johnson & Johnson argues that certain providers are misusing the 340B program, and that the company’s rebate plan meets the program's goal of keeping drugs available to low-income and uninsured patients.
On November 12, CMS released a report entitled Rural-Urban Disparities in Health Care in Medicare. The report presents information on the quality of health care received by people with Medicare nationwide, highlighting: 1) rural-urban differences in health care experiences and clinical care; 2) how rural-urban differences in health care experiences and clinical care vary by race and ethnicity; and 3) historic trends in quality of care for rural and urban residents.
On November 13, CMS announced the Essential Health Benefits (EHB)-Benchmark Plan Modernization Grant for States with a Federally-facilitated Exchange (FFE) Notice of Funding Opportunity (NOFO). The grants would fund states' efforts to review and potentially modernize their EHB benchmark plans due to enrollees having trouble accessing needed services, changes in medical evidence or scientific advancement, changes in the health needs of their populations, or other clinical considerations.
On November 14, HRSA announced a new nationwide campaign to raise public awareness of the National Maternal Mental Health Hotline (1-833-TLC-MAMA). As part of the campaign, HHS will collaborate with companies and organizations such as retailers, grocers, pharmacies, and health and community associations to publicize mental health resources for moms and pregnant women in everyday locations.
On November 14, FDA approved Kebilidi (eladocagene exuparvovec-tneq), an adeno-associated virus vector-based gene therapy indicated for the treatment of adult and pediatric patients with aromatic L-amino acid decarboxylase (AADC) deficiency. Kebilidi is the first FDA-approved gene therapy for treatment of AADC deficiency.
On November 14, CMS approved five Medicaid section 1115 demonstration amendments. These amendments will authorize Colorado, Hawaii, Minnesota, New York, and Pennsylvania to provide additional years of continuous eligibility for children beyond the minimum 12 months required by law and will newly provide continuous eligibility to individuals leaving incarceration in Colorado and Pennsylvania.
WHITE HOUSE
On November 14, president-elect Donald Trump nominated Robert F. Kennedy, Jr, to serve as Secretary of HHS. RFK Jr. has pledged to end “corporate corruption” at federal health and science agencies.
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
Administrative Simplification: Modifications to NCPDP Retail Pharmacy Standards (CMS-0056); Final Rule; 6/27/24
Amendments to Rules Governing Organ Procurement Organizations (CMS-3409); Proposed Rule; 8/8/24
Contract Year 2026 Policy and Technical Changes to the Medicare Advantage, Medicare Prescription Drug Benefit, and Medicare Cost Plan Programs, and PACE (CMS-4208); Proposed Rule; 9/20/24
Alternative Payment Model Updates; Increasing Organ Transplant Access (IOTA) Model (CMS-5535); Final Rule; 9/20/24
FDA
Expedited Program for Serious Conditions--Accelerated Approval of Drugs and Biologics; Draft Guidance for Industry; Availability; Notice; 7/9/24
Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions; Guidance for Industry and Food and Drug Administration Staff; Notice; 8/26/24
Nonprescription Drug Product With an Additional Condition for Nonprescription Use; Final Rule; 9/24/24
Notifying the Food and Drug Administration of a Permanent Discontinuance in the Manufacture or an Interruption of the Manufacture of an Infant Formula; Draft Guidance for Industry; Notice; 9/26/24
Considerations for Including Biopsies in Clinical Trials; Draft Guidance for Industry, Investigators, Institutions, and Institutional Review Boards; Notice; 9/27/24
Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products: Questions and Answers; Guidance for Industry (2023-663); Notice; 10/23/24
Validation of Certain In Vitro Diagnostic Devices for Emerging Pathogens During a Section 564 Declared Emergency; Draft Guidance for Industry and Food and Drug Administration Staff; Availability; Notice; 10/29/24
OASH
Organ Procurement and Transplantation: Implementation of the HIV Organ Policy Equity Act; Final Rule; 11/13/24
HEARINGS
House
Appropriations Committee
November 19; 10:00 AM; 2359-C Rayburn
Hearing: National Institutes of Health (NIH)
Witness: The Honorable Monica M. Bertagnolii, Director, NIH
Rescheduled to November 20; 10:30 AM; 2358-C Rayburn
Hearing: Social Security Administration
Witness: The Honorable Martin O'Malley, Commissioner, Social Security Administration
Judiciary Committee
November 20; 2:00 PM; 2141 Rayburn
Oversight of the Department of Health and Human Services’ Office of Refugee Resettlement
Witness: The Honorable Xavier Becerra, Secretary, HHS
Foreign Affairs Committee
Subcommittee on Global Health, Global Human Rights and International Organizations
November 20; 2:00 PM; 2172 Rayburn
Meeting the Challenges of Global Brain Health: Diagnosis and Treatment for the 21st Century
Witnesses: Gladys Maestre, M.D., Director, Alzheimer’s Disease Resource Center for Minority Aging Research, University of Texas; Benjamin Warf, M.D., Chairman, NeuroKid; Andy Shih, Chief Science Officer, Autism Speaks
REPORTS
Government Accountability Office (GAO)
On November 13, GAO released a report examining FDA’s drug safety inspection workforce. GAO found that FDA has struggled to retain staff and from November 2021 to June 2024, the vacancy rate among investigators who inspect foreign and domestic manufacturers jumped from 9% to 16%, leading to fewer inspections. FDA stated that concerns with travel, pay, training, workload, and work-life balance contribute to turnover. GAO recommends that FDA collaborate to develop and implement action plans to address the remaining root causes of investigator attrition that balance inspection needs against the need to retain investigators.
On November 13, GAO released a report examining HHS healthcare cybersecurity. Broadly, GAO stated that as the lead federal agency for the healthcare and public health critical infrastructure sector, HHS has faced challenges in carrying out its cybersecurity responsibilities. GAO found that HHS has not; 1) adequately monitored the sector's implementation of ransomware mitigation practices; 2) evaluated the effectiveness of the support it provides to the cybersecurity sector; and 3) conducted a comprehensive sector-wide cybersecurity risk assessment addressing IoT and OT devices. GAO stated that until HHS implements its prior recommendations related to improving cybersecurity, the department risks not being able to effectively carry out its lead agency responsibilities, resulting in potential adverse impacts on healthcare providers and patient care.
Office of Inspector General (OIG)
On November 14, OIG released a report examining hospice compliance with federal requirements for provider relief fund (PRF) payments. OIG found that the selected hospices reported that they used $80.2 million of their PRF payments to offset lost revenues, $89.8 million for general and administrative expenses, and $34.8 million for health care-related expenses. Of the 30 selected hospices, 23 hospices used PRF funds for allowable expenditures and lost revenues attributable to COVID-19; however, seven hospices did not comply with or may not have complied with Federal requirements. Of these seven hospices, which received $98.1 million in PRF payments, six hospices claimed a total of $8.3 million of unallowable PRF expenditures and inaccurately reported $1.5 million of lost revenues, and one hospice claimed $4 million in expenditures that may not have been allowable. OIG made two recommendations to HRSA, including that it require the selected hospices to return any unallowable expenditures to the Federal Government or ensure that the hospices properly account for these expenditures.
ADDITIONAL POLICY NEWS
On November 11, Cigna announced that it will not merge with Humana. A company press release stated that “the Cigna Group remains committed to its established M&A criteria and would only consider acquisitions that are strategically aligned, financially attractive, and have a high probability to close.”