Health Care Watch: December 9, 2023
The following Federal Health Policy (FHP) Strategies Weekly Health Care Watch provides a summary of legislative and regulatory health care activities from December 3 – December 9. 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 December 4, the House passed the Senate-amended Tranq Research Act which requires the National Institute of Standards and Technology (NIST) to coordinate science and research into illegal drugs containing the horse tranquilizer xylazine. The bill now heads to President Biden for his signature.
On December 6, the Energy & Commerce Committee advanced multiple pieces of health care legislation including provisions aimed at reigning in pharmacy benefit managers (PBMs), adjusting spread pricing, and expanding telehealth services.
On December 7, Energy & Commerce Committee Chair Cathy McMorris Rodgers (R-WA), Health Subcommittee Chairman Brett Guthrie (R-KY), and Oversight & Investigations Subcommittee Chairman Morgan Griffith (R-VA) wrote to Centers for Disease Control and Prevention (CDC) Director Mandy Cohen. The letter, which comes after Director Cohen’s testimony before the Oversight Subcommittee, follows up on a previous request made in June for information on the CDC’s lab safety practices. The Chairs note their intent to subpoena the documents should CDC not comply with the request.
On December 11, the House will vote on H.R. 5378, the Lower Costs, More Transparency Act. The legislation aims to increase transparency requirements for insurers, hospitals, and PBMs. A CBO score can be found here. The House will also consider H.R. 4531, the Support for Patients and Communities Reauthorization Act, which would extend numerous mental health and substance abuse treatment legislation.
Senate
On December 5, the Health, Education, Labor & Pensions (HELP) Committee announced that they have reached an agreement to markup legislation reauthorizing the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Reauthorization Act on December 12.
On December 5, the Appropriations Committee released a supplemental funding package that contains a $1.2 billion request by the Biden Administration to fight fentanyl by allowing sanctions on fentanyl cartels.
On December 5, the Finance Committee held a hearing entitled Drug Shortages: Examining Supply Challenges, Impacts, and Policy Solutions from a Federal Health Program Perspective. During the hearing, members discussed ongoing generic drug shortages and expert witnesses presented testimony and policy solutions to combat continuing shortages.
On December 5, HELP Committee Ranking Member Bill Cassidy (R-LA) released a request for information (RFI) from stakeholders on ways to improve and protect access to gene therapies for Americans with ultra-rare diseases. Ranking Member Cassidy stated that he hopes to use the feedback to inform future legislation to modernize and improve the market structure for gene therapies to ensure that the commercial health insurance market supports Americans with ultra-rare diseases.
On December 7, Finance Committee Chair Ron Wyden (D-OR) and Ranking Member Mike Crapo (R-ID) released legislative text for the committee-advanced Better Mental Health Care, Lower-Cost Drugs, and Extenders Act. The legislation would expand mental health care and substance use disorder services under Medicaid and Medicare and reduces prescription drug costs for seniors. The Finance Committee unanimously moved the legislation on November 8. A summary can be found here.
REGULATORY UPDATE
On December 3, the Department of Health & Human Services (HHS) delegation to the United Nations Climate Change Conference (COP28) released a Climate Change and Health Equity Strategy Supplement, outlining the work of agencies across the Department to support climate resilience and greenhouse gas emission reduction in the U.S. health sector. The Supplement describes HHS agencies' accomplishments and planned actions to help public health, health care and human services stakeholders better address climate-related risks and reduce their greenhouse gas emissions. The Supplement includes more than 50 planned actions – such as research programs, forecasting tools and technical assistance supports for communities and healthcare providers.
On December 4, Surgeon General Vivek Murthy released the 5-for-5 Connect Challenge as part of his strategy to combat loneliness and social isolation – problems he has identified as a profound threat to the nation’s health and well-being. The challenge encourages people to take one action a day to forge connection — like expressing gratitude, offering support or asking for help — for five days in a row.
On December 6, the Centers for Medicare & Medicaid Services (CMS) released the CMS Enforcement of State Compliance with Reporting and Federal Medicaid Renewal Requirements interim final rule with comment period. The interim final rule implements reporting requirements and enforcement authorities in the Social Security Act (the Act) that were added by the Consolidated Appropriations Act, 2023 (CAA). CMS will use these new enforcement authorities if States fail to comply with the new reporting requirements added by the CAA or with Federal Medicaid eligibility redetermination requirements during a timeframe that is generally aligned with the period when States are restoring eligibility. Comments are due by February 2, 2024.
On December 6, CMS released the 2023 Measures Under Consideration (MUC) List. The MUC List identifies the quality and efficiency measures under consideration by CMS for use in certain Medicare quality programs. An overview of the 2023 MUC List is now available on the Measures Management System (MMS) Hub. Highlights from the 2023 MUC List include:
A total of 42 measures, including 18 new measures not currently used in CMS programs, are included for consideration;
95% of the measures on the list use digital data sources, advancing the CMS National Quality Strategy goal of prioritizing the development of interoperable and digital quality measures;
10 measures addressing person-centered care, accelerating equity and engagement for all individuals, and seven measures addressing the Equity goal of the CMS National Quality Strategy.
On December 6, CMS announced that nearly 7.3 million Americans have signed up for 2024 individual market health insurance coverage through the Marketplaces since the start of the 2024 Marketplace Open Enrollment Period (OEP) on November 1. This includes 6.5 million plan selections in the 32 states using the HealthCare.gov platform for the 2024 plan year, through December 2, 2023 (Week 5), and 775,000 plan selections in the 18 states and the District of Columbia with State-based Marketplaces (SBMs) that are using their own eligibility and enrollment platforms, through November 25, 2023.
On December 6, HHS released a concept paper that outlines the Department’s cybersecurity strategy for the health care sector. The concept paper builds on the National Cybersecurity Strategy that President Biden released last year and focuses specifically on strengthening resilience for hospitals, patients, and communities threatened by cyber-attacks. The paper details four pillars for action, including publishing new voluntary health care-specific cybersecurity performance goals, working with Congress to develop supports and incentives for domestic hospitals to improve cybersecurity, and increasing accountability and coordination within the health care sector.
On December 7, HHS’ Office for Civil Rights (OCR), announced a settlement with Lafourche Medical Group, a Louisiana medical group specializing in emergency medicine, occupational medicine, and laboratory testing. The settlement resolves an investigation following a phishing attack that affected the electronic protected health information of approximately 34,862 individuals.
On December 8, FDA approved two cell-based gene therapies for the treatment of sickle cell disease in patients 12 years and older: Casgevy and Lyfgenia. One of these therapies, Casgevy, is the first FDA-approved treatment to utilize the CRISPR gene-editing technology.
On December 8, CMS announced a Disease, Disability, and Injury Prevention and Control Special Emphasis Panel on Occupational Safety and Health Education and Research Centers (ERC). The panel will take place from February 26-27, 2024. More information regarding the panel can be found here.
WHITE HOUSE
On December 7, the Biden Administration announced a number of health care initiatives including a proposed framework issued by NIST to help agencies more broadly use so-called “march-in rights” — a controversial policy that allows it to invalidate patent rights from drug manufacturers whose products rely on federally funded research. The framework lays out when the agency might assert this authority and endorses using a drug’s price in that determination. Comments on the proposed framework are due by February 6, 2024. A press release on the proposed framework can be found here.
On December 8, the White House Office of National Drug Control Policy (ONDCP), HHS, and the U.S. Department of Housing and Urban Development (HUD) issued a joint letter to public health departments and health care systems to partner with housing providers, community development organizations, and other housing agencies to help expand access to naloxone and other life-saving overdose reversal medications in the communities they serve.
RULES AT THE WHITE HOUSE OFFICE OF MANAGEMENT & BUDGET (OMB)
Pending Review
ASPR
Health Resources Priority and Allocations System (HRPAS); Final Rule; 11/17/23
CMS
Clinical Laboratory Improvement Amendments of 1988 (CLIA) Fees; Histocompatibility, Personnel, and Alternative Sanctions for Certificate of Waiver Laboratories (CMS-3326); Final Rule; 7/31/23
Strengthening Oversight of Accrediting Organizations (AO) and Preventing AO Conflict of Interest, and Related Provisions (CMS-3367); Proposed Rule; 12/27/22
Appeal Rights for Certain Changes in Patient Status (CMS-4204); Proposed Rule; 9/18/23
Interoperability and Prior Authorization for MA Organizations, Medicaid and CHIP Managed Care and State Agencies, FFE QHP Issuers, MIPS Eligible Clinicians, Eligible Hospitals and CAHs (CMS-0057); Final Rule; 10/25/23
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
Federal Independent Dispute Resolution Process Fees (CMS-9890); Final Rule; 11/14/23
Advance Notice of Methodological Changes for Calendar Year 2025 for Medicare Advantage Capitation Rates and Part C and Part D Payment Policies & Draft CY 2025 Part D Redesign Program Instructions; Proposed Rule; 12/1/23
FDA
Drug Products or Categories of Drug Products That Present Demonstrable Difficulties for Compounding Under Sections 503A or 503B of the Federal Food, Drug, and Cosmetic Act; Proposed Rule; 8/29/23
Collection of Race and Ethnicity Data in Clinical Trials and Clinical Studies for FDA-Regulated Medical Products; Revised Draft Guidance for Industry (CDER, 2023-36); Notice; 12/1/23
Medical Devices; Quality System Regulation Amendments; Final Rule; 12/6/23
Conducting Remote Regulatory Assessments--Questions and Answers; Revised Draft Guidance for Industry; Notice; 12/7/23
OCR
Safeguarding the Rights of Conscience as Protected by Federal Statutes; Final Rule; 9/15/23
Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing; Final Rule; 10/19/23
Confidentiality of Substance Use Disorder Patient Records; Final Rule; 12/4/23
SAMHSA
Medications for the Treatment of Opioid Use Disorder; Final Rule; 10/24/23
IHS
Calendar Year 2024 Reimbursement Rates Notice; Notice; 11/10/23
REPORTS
Office of Inspector General (OIG)
On December 6, OIG released a report examining Louisiana nursing homes’ compliance with requirements that prohibit employment of individuals with disqualifying background checks. OIG found that Louisiana ensured, for the period October 1, 2019, to June 30, 2021, that all nine selected nursing homes in the State complied with Federal requirements that prohibit the employment of individuals with disqualifying backgrounds. In addition, OIG determined that 77 licensed employees who were selected for review from the same 9 selected nursing homes were free from any disciplinary action against their professional license; thus, their licensure statuses were in good standing. OIG recommends that Louisiana conduct routine monitoring of nursing homes' compliance with background check requirements.
UPCOMING HEARINGS
House
Energy & Commerce Committee
December 13, 10:00 AM; 2123 Rayburn
Hearing on Leveraging Agency Expertise to Foster American AI Leadership and Innovation
Witnesses: Helena Fu, Director of Critical and Emerging Technology, Office of the Undersecretary for Science, Department of Energy; Dr. Micky Tripathi, National Coordinator for Health Information Tech, HHS; Saif Khan, Senior Advisor to Secretary for Critical and Emerging Technologies, Department of Commerce.
Senate
HELP Committee
December 12; 10:00 AM; SD-430
Executive Session: S. 1840, S. 3392, S. 3393, and S. 644
Legislation to be discussed: S. 1840, SCREENS for Cancer Act of 2023; S. 3392, Advancing Research in Education Act; S. 3393, SUPPORT for Patients and Communities Reauthorization Act; S. 644, Modernizing Opioid Treatment Access Act.
December 14; 10:00 AM; SD-430
Hearing on What is Fueling the Diabetes Epidemic?
January 25; 10:00 AM
Why Does the United States Pay, By Far, The Highest Prices in the World for Prescription Drugs?
OTHER POLICY NEWS
On December 7 and 8, the Medicare Payment Advisory Commission (MedPAC) held its monthly public meetings. The meetings discussed Medicare payment adequacy of hospital inpatient and outpatient services, hospice services, outpatient dialysis services, skilled nursing facility services, home health care services, and inpatient rehabilitation facility services.