Health Care Watch: February 12, 2024
The following Federal Health Policy (FHP) Strategies Weekly Health Care Watch provides a summary of legislative and regulatory health care activities from February 5 – February 11. 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 February 5, the Rules Committee voted along party lines to advance H.R. 485, the Protecting Health Care for All Patients Act of 2023. The legislation would prohibit the use of quality-adjusted life years (QALYs) in federal health care programs. The House passed the legislation in a 211-208 vote on February 7.
On February 6, the Budget Committee voted unanimously to advance H.R. 766, the Preventive Health Savings Act. The legislation would reform how the Congressional Budget Office (CBO) handles estimates of preventative health care by requiring CBO to weigh whether a bill would save money over a 30-year budget window, as opposed to 10-year window.
On February 6, the Oversight and Accountability Committee advanced H.R. 6283, the Delinking Revenue from Unfair Gouging (DRUG) Act. The legislation would implement a flat service fee to compensate pharmacy benefit managers (PBMs) and would ban spread pricing.
On February 8, Energy & Commerce Committee Chair Cathy McMorris Rodgers (R-WA) announced that she will not seek reelection. Reps. Brett Guthrie (R-KY) and Bob Latta (R-OH) will run for the position. Rep. Richard Hudson (R-NC) may also enter the race.
Senate
On February 6, Health, Education, Labor & Pensions (HELP) Committee Chairman Bernie Sanders (I-VT) released a reportahead of the Committee’s hearing on rising drug prices with testimony from Bristol Myers Squibb, Johnson & Johnson and Merck CEOs. The report examines the drug companies’ business practices, stating that the companies' prices tend to rise over time.
On February 8, the HELP Committee held a hearing entitled Why Does the United States Pay, by Far, the Highest Prices in the World for Prescription Drugs. During the hearing, CEOs from Johnson & Johnson, Merck and Bristol Myers Squibb testified regarding their drugs prices and business practices.
On February 8, Sens. Marco Rubio (R-FL) and Tom Carper (D-DE) announced new legislation that would extend and expand at-home care for patients by creating a new pilot program that would test coverage of outpatient observation services furnished outside a hospital under the Acute Hospital Care at Home initiative.
On February 8, Sens. Marco Rubio (R-FL) and Tom Carper (D-DE) announced new legislation that would extend and expand at-home care for patients by creating a new pilot program that would test coverage of outpatient observation services furnished outside a hospital under the Acute Hospital Care at Home initiative.
On February 8, Sens. Martin Heinrich (D-NM) and Mike Braun (R-IN) led a letter to Food & Drug Administration (FDA) Commissioner Robert Califf asking the agency to include opioid use disorder (OUD) treatments, buprenorphine and methadone, on FDA’s List of Essential Medicines.
On February 8, the Finance Committee held a hearing entitled Artificial Intelligence (AI) and Health Care: Promise and Pitfalls. The hearing discussed the use of AI in health care and contained testimony from expert witnesses detailing the benefits, biases, and drawbacks of breakthrough AI technologies.
REGULATORY UPDATE
On February 5, FDA’s Center for Drug Evaluation and Research (CDER) released this year’s CDER Guidance Agenda, a list of new, revised draft, and immediately-in-effect guidance documents it plans to publish this year. The guidance includes a new document on AI that details what drugmakers should consider when using AI to generate data that supports applications for drug or biologic products.
On February 5, the Centers for Medicare & Medicaid Services (CMS) announced that it is publishing the Inpatient Rehabilitation Facility Patient Assessment Instrument (IRF-PAI) Manual, Version 4.2, effective October 1, 2024. The Manual and Change Table can be accessed here.
On February 5, Department of Health & Human Services (HHS) Secretary Xavier Becerra met virtually with pharmacy CEOs and leaders, to discuss COVID-19 therapeutics commercialization. Secretary Becerra reconvened pharmacy leaders as a follow-up to his larger meeting with pharmacies, PBMs, and insurers in January 2024. During the call, Secretary Becerra reiterated that no patient should be charged “hundreds of dollars” for Paxlovid at the pharmacy counter – stressing the importance of pharmacist education and clear communication to patients. Secretary Becerra reminded pharmacy leaders of the pathways for access that HHS negotiated with Pfizer and made it clear that HHS would continue to engage with pharmacist leadership as needed.
On February 5, CMS published a summary report covering the public, virtual listening session that was held on August 29, 2023 to seek feedback from administration and management staff, software vendors, and clinical staff on the possible expansion of collection and submission of Minimum Data Set (MDS) assessment data used for the Skilled Nursing Facility (SNF) Quality Reporting Program (QRP).
On February 6, HHS’ Office for Civil Rights (OCR) announced a settlement with Montefiore Medical Center, a non-profit hospital system based in New York City, for several potential violations of the Health Insurance Portability and Accountability Act (HIPAA) Security Rule. The $4.75 million monetary settlement and corrective action resolves multiple potential failures by Montefiore Medical Center relating to data security failures that led to an employee stealing and selling patients’ protected health information over a six-month period.
On February 6, the Health Resources and Services Administration (HRSA) announced steps aimed at "improving transparency, performance, governance, and efficiency" of the Organ Procurement and Transplantation Network (OPTN). Since its inception over 40-years ago, all functions of the OPTN were managed by a single vendor rather than multiple contracts based on technical expertise in areas like IT or operations. HRSA is attempting to break up this monopoly by issuing requests for proposals (RFPs) to support multiple different contract awards to access best-in-class vendors. HRSA is also creating an OPTN Board of Directors independent from other OPTN contractors to strengthen accountability and oversight. Finally, HRSA is making changes to modernize the critical organ matching technology while increasing transparency and accountability by issuing new data reporting requirements to better address pre-waitlist and organ procurement practices. Additional information on these initiatives can be found here.
On February 6, HHS released the National Public Health Strategy to Prevent and Control Vector-Borne Diseases in People (VBD National Strategy). The strategy identifies and describes federal priorities to detect, prevent, respond to, and control diseases and conditions caused by vectors in the United States. This collaborative effort will help to address the significant public health challenges related to vector-borne diseases, incorporate a One Health approach to enhance coordination, and reverse the upward trends in illness, suffering, and death.
On February 6, the Association for Community Living (ACL) released a final rule to update the regulations for implementing its Older Americans Act (OAA) programs. The rule aligns regulations to the current statute, addresses issues that have emerged since the last update and clarifies several requirements. Additionally, the final rule aims to better support the national aging network that delivers OAA services and improves program implementation, with the goal of ensuring that the nation's growing population of older adults can continue to receive the services and supports they need to live in their own homes. The new regulations will take effect on March 15, 2024, but regulated entities have until October 1, 2025, to comply.
On February 6, HHS, through CMS, approved a proposal from New Mexico for community-based mobile crisis intervention teams to provide Medicaid crisis services. New Mexico is the 15th state to expand access to community-based mental health and substance use crisis care. With this approval, the state will be able to provide Medicaid services through mobile crisis teams by connecting eligible individuals in crisis to a behavioral health provider 24 hours per day, 365 days a year.
On February 6, CMS released corrections to the Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems; Quality Reporting Programs final rule. The corrections address technical and typographical errors in the final rule and can be found here.
On February 8, HHS, through its Office for Civil Rights (OCR) and the Substance Abuse and Mental Health Services Administration (SAMHSA), finalized modifications to the Confidentiality of Substance Use Disorder (SUD) Patient Records regulations at 42 CFR part 2 (“Part 2”) final rule, which protects the privacy of patients’ SUD treatment records. Specifically, the final rule increases coordination among providers treating patients for SUDs, strengthens confidentiality protections through civil enforcement, and enhances integration of behavioral health information with other medical records to improve patient health outcomes. The final rule permits use and disclosure of Part 2 records based on a single patient consent given once for all future uses and disclosures for treatment, payment, and health care operations and permits redisclosure of Part 2 records by HIPAA covered entities and business associates in accordance with the HIPAA Privacy Rule, with certain exceptions. A fact sheet detailing the final rule can be found here.
On February 8, CMS released the Strengthening Oversight of Accrediting Organizations (AOs) and Preventing Accrediting Organization Conflict of Interest proposed rule. The proposed rule would strengthen oversight of AOs, reduce conflicts of interest, and strive for enhanced consistency of survey processes. Specifically, the rule proposes to: hold AOs accountable to the same standards as State Survey Agencies (SAs); ensure that AOs remain independent reviewers by addressing conflicts of interest; prevent AO conflicts of interest; address potential and actual conflicts of interest; and improve AO performance, consistency and standardization in surveys nationwide. A fact sheet detailing the proposed rule can be found here. Comments are due April 15, 2024.
On February 9, HHS and the Department of Housing and Urban Development (HUD) announced that eight states and the District of Columbia (DC) have been selected to participate in a new federal initiative, known as the Housing and Services Partnership Accelerator (Accelerator), to help strengthen partnerships across housing, disability, aging, and health sectors; access available federal programs and resources, and maximize federal flexibilities to help keep people healthy. The Accelerator will help eight states and DC unlock critical resources to reduce homelessness by addressing health-related social needs, such as housing-related services.
WHITE HOUSE
On February 5, President Biden named Stephanie Psaki as his global health security coordinator. Psaki will help organize the government’s response when an emerging health threat is detected overseas.
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
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
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 February 6, OIG released a report examining Colorado nursing home compliance with federal requirements for life safety, emergency preparedness, and infection control. OIG found that Colorado could better ensure that nursing homes in the state that participated in the Medicare or Medicaid programs comply with Federal requirements for life safety, emergency preparedness, and infection control. During onsite visits, OIG identified deficiencies related to life safety, emergency preparedness, or infection control at all 20 nursing homes that were audited, totaling 556 deficiencies. Specifically, OIG identified 165 deficiencies related to life safety requirements, 210 deficiencies related to emergency preparedness requirements, and 181 deficiencies related to infection control requirements. OIG recommends that Colorado follow up with the 20 nursing homes reviewed in the audit to ensure that corrective actions have been taken regarding the life safety, emergency preparedness, and infection control deficiencies and work with CMS to develop a risk-based approach to identify nursing homes at which surveys would be conducted more frequently.
UPCOMING HEARINGS
House
Energy and Commerce Committee
Health Subcommittee
February 14; 10:00 AM; 2121 Rayburn