Health Care Watch: July 22, 2024
The following Federal Health Policy (FHP) Strategies Weekly Health Care Watch provides a summary of legislative and regulatory health care activities from July 14 – July 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
The House returns from its recess on July 22.
Senate
On July 16, Judiciary Committee Chairman Dick Durbin (D-IL) launched an inquiry into medical and mental health care for people in custody in U.S. Immigration and Customs Enforcement (ICE) detention facilities, requesting information from ICE as well as requesting an audit of ICE’s mental health care services by the Government Accountability Office (GAO).
On July 18, Health, Education, Labor & Pensions (HELP) Committee Ranking Member Bill Cassidy (R-LA) announced that the HELP Committee will vote on July 25 to consider a subpoena to compel Steward Health CEO Dr. Ralph de la Torre to testify on the company’s financial mismanagement of its hospitals which resulted in Steward filing for bankruptcy in May 2024.
The Senate returns from its recess on July 23.
REGULATORY UPDATE
On July 15, the Food & Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) announced new organizational changes to help strengthen the Center. The changes aim to increase organizational agility and advance efforts to meet commitments under the Medical Device User Fee Amendments (MDUFA) reauthorization, as well as CDRH’s 2022-2025 Strategic Priorities. Specifically, CDRH is elevating the Office of Communication and Education (OCE) into a “Super Office” and creating a new Division of Digital Communication and Marketing. The new Super Office will be responsible for delivering clear, meaningful, insights-based communications, education, and disclosures about medical devices and radiation-emitting products.
On July 16, the Centers for Medicare & Medicaid Services (CMS) released the final part two guidance regarding Part D plan sponsor outreach and education for the Medicare Prescription Payment Plan. Beginning in 2025, the Medicare Prescription Payment Plan provides the option to people with Medicare prescription drug coverage to spread the costs of their prescription drugs over the calendar year rather than paying in full each time they fill a prescription. People with Medicare must opt into the Medicare Prescription Payment Plan to utilize the new benefit. In addition to the final guidance, CMS also released six model documents to support Part D plans in meeting the payment plan requirements.
On July 16, the Health Resources and Services Administration (HRSA) announced the first-ever Licensure Portability Grant Program investment in a multi-state social worker licensure compact. HRSA’s new $2.5 million investment in licensure compacts will support the work to launch a social worker compact as well as HRSA’s ongoing support for building and sustaining primary care, psychology, and podiatry compacts. HRSA aims to expand access to behavioral health services through these investments.
On July 16, the Department of Health & Human Services (HHS) released a statement regarding the second anniversary of the 988 Suicide & Crisis Lifeline. HHS stated that it has invested nearly $1.5 billion into 988 resulting in more than 10 million calls, texts, and chats to the line. HHS stated that it will continue to work to improve the efficiency and reach of the 988 crisis lifeline.
On July 16, FDA released revised final guidance entitled Application User Fees for Combination Products. The document addresses how the Agency applies user fees for combination products when separate applications are submitted for the constituent parts. It also includes revisions for consistency with current medical device and drug user fee programs and legislation.
On July 17, FDA announced that it plans to establish a Rare Disease Innovation Hub. The Hub will work across rare diseases and will focus on products intended for smaller populations or for diseases where the natural history is variable and not fully understood. The Hub will have three primary functions: 1) serve as a single point of connection and engagement with the rare disease community; 2) enhance intercenter collaboration to address common scientific, clinical and policy issues related to rare disease product development; and 3) advance regulatory science with dedicated workstreams for consideration of novel endpoints, biomarker development and assays, innovative trial design, real world evidence, and statistical methods. FDA plans to hold an open public meeting in the fall to collect feedback on the hub’s priorities.
On July 19, CMS released a statement on system changes to stop unauthorized agent and broker marketplace activity. CMS stated that it will immediately block an agent or broker from making changes to a consumer’s Federally-facilitated Marketplace (FFM) enrollment unless the agent is already associated with the consumer’s enrollment. Unassociated or “new” agents and brokers will be required to conduct a three-way call with the consumer and the Marketplace Call Center or to direct the consumer to submit the change themselves through HealthCare.gov or via an approved Classic Direct Enrollment or Enhanced Direct Enrollment partner website with a consumer pathway.
WHITE HOUSE
On June 21, President Joe Biden announced that he would not seek re-election and endorsed Vice President Kamala Harris for the nomination.
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
Administrative Simplification: Modifications to NCPDP Retail Pharmacy Standards (CMS-0056); Final Rule; 6/27/24
Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals; the Long-Term Care Hospital Prospective Payment System; and FY 2025 Rates (CMS-1808); Final Rule; 6/28/24
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); Final Rule; 6/28/24
FY 2025 Inpatient Rehabilitation Facility (IRF) Prospective Payment System Rate Update and Quality Reporting Program (CMS-1804); Final Rule; 7/2/24
FY 2025 Hospice Wage Index, Payment Rate Update, and Quality Reporting Requirements (CMS-1810); Final Rule; 7/8/24
FY 2025 Inpatient Psychiatric Facilities Prospective Payment System Rate and Quality Reporting Updates (CMS-1806); Final Rule; 7/8/24
HHS Notice of Benefit and Payment Parameters for 2026 (CMS-9888); Proposed Rule; 7/17/24
FDA
Expedited Program for Serious Conditions--Accelerated Approval of Drugs and Biologics; Draft Guidance for Industry; Availability; Notice; 7/9/24
REPORTS
Office of Inspector General (OIG)
On July 16, OIG released a report examining the Administration for Strategic Preparedness and Response’s (ASPR) compliance with federal requirements for awarding research and development contracts. OIG found that ASPR did not always award research and development contracts, including those awarded using the Biomedical Advanced Research and Development Authority (BARDA) DRIVe and ASPR Next programs, in accordance with Federal Acquisition Regulation (FAR) and HHS Acquisition Regulation requirements. Specifically, the contracting officers did not: 1) complete novation procedures timely upon the contractor’s sale of its business; and 2) properly finalize one contract before authorizing work to begin. Additionally, ASPR did not properly document all key administrative matters, including contracting decisions or activities for nine contracts. OIG made several recommendations, including that ASPR: 1) implement a review process to verify that Federal acquisition awarding procedures and contract funding are fully completed before contract performance begins; 2) correct the Recording Statute violation for the contract that was not properly finalized by ratifying the original contract and properly recording an obligation; and 3) correct the time violation for the improperly created purchase order by using no-year funds or multi-year funds available for obligation and report an Antideficiency Act violation if the time violation cannot be corrected
UPCOMING HEARINGS
House
Energy & Commerce Committee
Health Subcommittee
July 23; 10:30 AM; 2322 Rayburn
Are CDC's Priorities Restoring Public Trust and Improving the Health of the American People?
Witnesses: Dr. Karen Hacker, Director, National Center for Chronic Disease Prevention and Health Promotion, CDC; Dr. Allison Arwady, Director, National Center for Injury Prevention and Control, CDC; Dr. Daniel Jernigan, Director, National Center for Emerging and Zoonotic Infectious Diseases, CDC; Dr. Demetre Daskalakis, Director, National Center for Immunization and Respiratory Diseases, CDC; Dr. Henry Walke, Director, Office of Readiness and Response, CDC; Dr. Jennifer Layden, Director, Office of Public Health Data, Surveillance, and Technology, U.S. CDC
Oversight and Accountability Committee
July 23; 10:00 AM; 2154 Rayburn
The Role of Pharmacy Benefit Managers in Prescription Drug Markets Part III: Transparency and Accountability
Potential Witnesses: Representatives from Optum Rx, CVS Caremark, and Express Scripts
Senate
HELP Committee
September 24; 10:00 AM; SD-562
July 25; 10:00 AM; 562 Dirksen
Executive Session: Authorization for Investigation into the Bankruptcy of Steward Health Care
Authorization for Subpoena of Dr. Ralph de la Torre, Chairman and CEO, Steward Health Care Systems LLC, for Testimony Relating to the Committee Investigation into the Bankruptcy of Steward Health Care
Judiciary Committee
July 23; 9:30 AM; Field Hearing
Health Impacts of Abortion Ban on Georgia Women
Witnesses: TBA
ADDITIONAL POLICY NEWS
On July 15, Former President Donald Trump announced that he has selected Sen. J.D. Vance (R-OH) as his running mate for the 2024 Presidential Election. Sen. Vance has represented Ohio since 2023.
On July 16, the Medicare Payment Advisory Commission (MedPAC) released the 2024 data book on health care spending and the Medicare program. The publication provides data on Medicare spending, demographics of the Medicare population, beneficiaries' access to care, and quality of care in the program. The full data book can be found here.
On July 16, a federal judge ruled in favor of CMS rejecting the state of Georgia’s request to extend its Medicaid work requirement program. The judge ruled that the state must go through the CMS formal process to request an extension of the Medicaid waiver for the program. Georgia officials alleged the program’s waiver should be extended beyond 2025 because CMS delayed its implementation by two years. The program will expire in September 2025, unless CMS approves its extension.
On July 17, a panel of judges from the U.S. Court of Appeals for the 6th Circuit heard oral arguments in one of the first cases affected by the Supreme Court’s recent Chevron ruling. The State of Tennessee argues that Title X rules on abortion have been inconsistent in recent years and HHS’s counseling requirement violates its residents’ First and 10th amendment rights. It is expected that Tennessee will argue that the Supreme Court’s decision overturning the Chevron doctrine requires the appeals court to scrutinize the law itself rather than deferring to the agency’s interpretation.
On July 19, a widespread outage to Microsoft systems took down computers in health systems around the globe. The issue appears to have stemmed from a software update from the cybersecurity firm CrowdStrike, which disabled computers running Microsoft Windows.