Health Care Watch: April 22, 2024
The following Federal Health Policy (FHP) Strategies Weekly Health Care Watch provides a summary of legislative and regulatory health care activities from April 14 – April 21. 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 15, bipartisan leaders from the Energy & Commerce Committee sent a letter to UnitedHealth Group, Inc., CEO Andrew Witty seeking information about the cyberattack on Change Healthcare. The letter asks for Mr. Witty to answer questions regarding the restoration of Change Healthcare systems and the number of transactions affected by the cyberattack. The Committee leaders requested answers by April 29, 2024.
On April 16, the Energy & Commerce Health Subcommittee held a hearing entitled Examining Health Sector Cybersecurity in the Wake of the Change Healthcare Attack. The hearing discussed actions taken by the federal government, doctors, hospitals, and other groups to combat the effects of the Change Healthcare cyberattack. Additionally, during the hearing, many members of the Committee called for UnitedHealth Group to be subpoenaed to learn more about the cyberattack on its subsidiary. A hearing memo can be found here.
On April 16, the Energy & Commerce Oversight & Investigations Subcommittee held a hearing on improper payments in the Medicare and Medicaid programs. The hearing focused on ways to strengthen oversight, reduce improper payments, and ensure efficient use of taxpayer dollars. A hearing memo can be found here.
The House is in recess until April 29.
Senate
On April 15, Special Committee on Aging Chairman Bob Casey (D-PA) and Sens. Tim Kaine (D-VA) and Tammy Baldwin (D-WI) introduced the Long-Term Care Workforce Support Act. The legislation aims to tackle the caregiving crisis by reprioritizing long-term caregivers and supporting their work based on the value they bring to families across the nation. Specifically, the legislation would: increase the number of direct care professionals; provide pathways to enter and be supported in the workforce for women, people of color, and people with disabilities; improve compensation for direct care professionals to reduce vacancies and turnover; and improve access and quality of long-term care for families.
On April 17, Health, Education, Labor & Pensions (HELP) Committee Ranking Member Bill Cassidy (R-LA) sent a letterto Food & Drug Administration (FDA) Commissioner Robert Califf rebuking FDA’s policy to expand its oversight over clinical decision support (CDS) software. Ranking Member Cassidy states that the policy goes beyond FDA’s statutory authority and limits access to crucial technology used to improve delivery of health care services. The letter asks that FDA respond to questions regarding its decision to regulate CDS by May 1, 2024.
The Senate is in recess until April 29.
REGULATORY UPDATE
On April 15, FDA announced the launch of the Center for Drug Evaluation and Research (CDER) Center for Clinical Trial Innovation (C3TI). C3TI’s mission is to promote CDER clinical trial innovation activities through enhanced communication and collaboration, both internally within CDER and externally. C3TI will be a central hub within CDER that supports innovative approaches to clinical trials that are designed to improve the efficiency of drug development.More information about C3TI can be found here.
On April 15, the Centers for Medicare & Medicaid Services (CMS) released the updated Skilled Nursing Facility (SNF) Provider Preview Reports. The reports contain provider performance scores for quality measures and can be found hereduring the July 2024 refresh.
On April 18, Department of Health & Human Services (HHS) senior leadership released statements on the one-year anniversary of President Biden’s Executive Order on increasing access to high-quality care and supporting caregivers. HHS Secretary Xavier Becerra stated that the Department will continue to work on policies that promote caregiver support and increase quality of care for all patients.
On April 18, the Health Resources and Services Administration (HRSA) released a final rule that lays out the 340B Program’s administrative dispute resolution process. The final rule enables all covered health-care entities to present disagreements with drugmakers over prices to a panel of experts from HRSA. The rule also establishes a timeline for dispute resolution decisions and provides an opportunity for parties unhappy with the panel’s initial decision to request reconsideration.
On April 18, the Federal Trade Commission (FTC), Department of Justice (DOJ), and HHS launched a portal for the public to submit healthcare competition complaints.
On April 18, FDA’s Center for Devices and Radiological Health released two annual reports on medical device safety and innovation.
White House
On April 16, the Biden Administration launched the U.S. Global Health Security Strategy (GHSS). The strategy outlines actions the U.S. will take over the next five years to prevent, detect, and effectively respond to biological threats wherever they emerge. The strategy sets out three goals to guide the United States’ affirmative agenda to advance global health security: 1) strengthen global health security capacities through bilateral partnerships; 2) catalyze political commitment, financing, and leadership to achieve health security; and 3) increase linkages between health security and complementary programs to maximize impact. A fact sheet detailing the strategy 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
Alternative Payment Model Updates; Increasing Organ Transplant Access (IOTA) Model (CMS-5535); Proposed Rule; 11/9/23
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
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 15, GAO released a report detailing states’ regulation of pharmacy benefit managers (PBMs). GAO reviewed PBM laws in five states – Arkansas, California, Louisiana, Maine, and New York – and found that: 1) four of the five states enacted laws to impose a duty of care on PBMs; 2) all five states enacted a variety of laws relating to drug pricing and pharmacy payments; 3) all five states enacted laws that require PBMs to be licensed by or registered with the state, or both, and to report certain information such as drug pricing, fees charged, and the amounts of rebates received and retained; and 4) all five states enacted laws regarding pharmacy networks and patient access. GAO did not make any recommendations in this report.
On April 16, GAO released a report detailing actions needed to enhance Medicare and Medicaid program integrity. GAO stated that HHS estimated a combined total of over $100 billion in improper payments in the Medicare and Medicaid programs in fiscal year 2023, representing 43% of the government-wide total of estimated improper payments that agencies reported for that year. GAO found that CMS action on recommendations that remain unimplemented would further enhance program integrity and save billions of dollars in Medicare and Medicaid spending. GAO made several recommendations to CMS prior to the report, including that CMS: expand its review of states' implementation of provider screening and enrollment requirements in Medicaid, and monitor progress when states are not fully compliant; implement a risk-based plan for revalidating enrollment for Medicare providers after pauses during the COVID-19 pandemic; and seek legislative authority to allow Recovery Auditors to conduct prepayment claim reviews. GAO stated that as of March 2024, over 100 recommendations to CMS remain unimplemented, including 15 related to improper payments.
On April 18, GAO released a report examining HHS’ response to mpox. GAO found that the six states, the District of Columbia, and seven local jurisdictions GAO interviewed described challenges with HHS' initial response to mpox that were similar to those GAO identified in HHS' response to past emergencies. Specifically, jurisdictions noted challenges with communication and the availability of vaccines, tests, and treatments, among other problems. Similar persistent and recurring deficiencies led GAO to add HHS' leadership and coordination of public health emergencies to its High-Risk List in January 2022, calling for an HHS leadership commitment to transform its efforts. GAO recommends that HHS adopt a coordinated, department-wide program that incorporates input from external stakeholders to identify and resolve challenges.
Congressional Budget Office (CBO)
On April 16, CBO released a report entitled Medicare Accountable Care Organizations (ACOs): Past Performance and Future Directions. CBO found that certain types of ACOs are associated with greater savings. The report found that ACOs led by independent physician groups, ACOs with a larger proportion of primary care providers (PCPs), and ACOs whose initial baseline spending was higher than the regional average, are associated with greater savings. Additionally, CBO found that some factors limit the savings from Medicare ACOs, including weak incentives for ACOs to reduce spending, a lack of the resources necessary for providers to participate in ACO models, and providers’ ability to selectively enter and exit the program on the basis of the financial benefits or losses they anticipate from participating.
UPCOMING HEARINGS
House
Energy & Commerce Committee
May 1; TBD
Hearing examining the Change Healthcare Cyberattack
Likely Witness: United Health Group CEO Andrew Witty
Senate
Finance Committee
April 30; TBD
Hearing on UnitedHealth Group
Likely Witness: United Health Group CEO Andrew Witty
Budget Committee
TBD
Hearing on Competition on Health Care
OTHER POLICY NEWS
On April 16, Alvotech and Teva Pharmaceuticals announced that the FDA has approved Selarsdi, a biosimilar version of the psoriasis drug Stelara. Selarsdi will enter the market on or after February 21, 2025, following a settlement with Johnson & Johnson, the manufacturer of Stelara. Selarsdi is the second biosimilar approved for Stelara. The first Stelara biosimilar, Amgen’s Wezlana, received FDA approval in October 2023 with interchangeable status. Stelara’s biosimilars could impact the drug’s selection as one of the 10 drugs selected for negotiation under the first year of the Medicare Drug Price Negotiation Program, assuming the biosimilars capture adequate market share.
On April 16, the Florida Agency for Health Care Administration filed a lawsuit against the Biden Administration regarding a new mandate requiring 12 months of continuous coverage for eligible minors in Medicaid and the Children’s Health Insurance Program (CHIP). The lawsuit alleges that CMS overstepped its authority by prohibiting states from removing children from the safety-net programs, even if monthly premiums remain unpaid. Florida is seeking a preliminary injunction.