Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies, and analyses; and other health policy news.

Week in Review Highlight of the Week:

This week, the House Committee on Energy and Commerce Subcommittee on Health held a hearing on artificial intelligence (AI) and its impact on healthcare, and CMS extended the application deadline for the Making Care Primary (MCP) Model until December 14, 2023.

I. Regulations, Notices & Guidance

• On November 27, the Centers for Disease Control and Prevention (CDC) issued a notice entitled, Reporting of Pregnancy Success Rates from Assisted Reproductive Technology (ART) Programs; Proposed Modifications to Data Collection Fields and Data Validation Procedures; Request for Comment. The CDC is announcing the opening of a docket to obtain comment on and review of proposed modifications to data collection fields for reporting of pregnancy success rates from assisted reproductive technology (ART) programs and proposed modifications to data validation procedures. This reporting is required by the Fertility Clinic Success Rate and Certification Act of 1992 (FCSRCA).
• On November 27, the Department of Veterans Affairs (VA) issued a final rule entitled, Payments Under State Home Care Agreements for Nursing Home Care. The VA finalized a proposed rule, with one change, amending its state home per diem regulation to provide a new formula for calculating the prevailing rate VA would pay a State home that enters into a State home care agreement to provide nursing home care to eligible veterans
• On November 29, 2023, the Centers for Medicare & Medicaid Services (CMS) issued a notice entitled, Privacy Act of 1974; Matching Program. In accordance with the Privacy Act of 1974, the Department of Health and Human Services (HHS) and CMS are providing notice of the re-establishment of a matching program between CMS and the Peace Corps for Verification of Eligibility for Minimum Essential Coverage Under the Patient Protection and Affordable Care Act through a Peace Corps Health Benefit Plan.
• On November 29, 2023, the Food and Drug Administration (FDA) issued a notice entitled, Effective Date of Requirement for Premarket Approval Applications for Certain Solid Wound Dressings; Wound Dressings Formulated as a Gel, Cream, or Ointment; and Liquid Wound Washes Containing Medically Important Antimicrobials. FDA is proposing to require the filing of a premarket approval application (PMA) for certain solid wound dressings; wound dressings formulated as a gel, cream, or ointment; and liquid wound washes containing antimicrobials with a high level of antimicrobial resistance (AMR) concern (i.e., medically important antimicrobials) acting as either protectants or preservatives, which are unclassified, preamendment devices. FDA is summarizing its proposed findings regarding the degree or risk of illness or injury designed to be eliminated or reduced by requiring the devices to meet the PMA requirements of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the benefits to the public from the use of the devices.
• On November 29, 2023, FDA issued a proposed rule entitled, Medical Devices; General and Plastic Surgery Devices; Classification of Certain Solid Wound Dressings; Wound Dressings Formulated as a Gel, Creams, or Ointment; and Liquid Wound Washes. FDA is proposing to classify certain types of wound dressings and liquid wound washes containing antimicrobials and/or other chemicals (unclassified, preamendment devices) as solid wound dressings; wound dressings formulated as a gel, cream, or ointment; and liquid wound washes. FDA currently regulates these unclassified devices as devices requiring premarket notification, with the product codes FRO, GER, MGP, MGQ, and EFQ, but FDA intends to create new product codes for these proposed classifications upon finalization of this classification action. FDA is proposing to classify certain wound dressings and liquid wound washes containing antimicrobials with a high level of antimicrobial resistance (AMR) concern (i.e., medically important antimicrobials) into class III. In addition, FDA is proposing to classify certain wound dressings and liquid wound washes containing antimicrobials with a medium or low level of AMR concern and/or other chemicals, into class II.
• On November 30, 2023, CDC issued a notice entitled, Board of Scientific Counselors, Office of Readiness and Response; (Formerly Known as the Board of Scientific Counselors, Center for Preparedness and Response); Notice of Charter Renewal. CDC is announcing the renewal of the charter of the Board of Scientific Counselors, Office of Readiness and Response (BSC, ORR); (formerly known as the Board of Scientific Counselors, Center for Preparedness and Response (BSC, CPR)).
• On November 30, 2023, CDC issued a notice entitled, CDC Recommendations for Hepatitis C Testing Among Perinatally Exposed Infants and Children-United States, 2023. CDC is announcing the availability of the final CDC Recommendations for Hepatitis C Testing Among Perinatally Exposed Infants and Children—United States, 2023.
• On November 30, 2023, the Substance Abuse and Mental Health Services Administration (SAMHSA) issued a notice entitled, Current List of HHS-Certified Laboratories and Instrumented Initial Testing Facilities Which Meet Minimum Standards To Engage in Urine and Oral Fluid Drug Testing for Federal Agencies. SAMHSA is notifying Federal agencies of the laboratories and Instrumented Initial Testing Facilities (IITFs) currently certified to meet the standards of the Mandatory Guidelines for Federal Workplace Drug Testing Programs using Urine or Oral Fluid (Mandatory Guidelines).
• On December 1, 2023, the Office of Inspector General (OIG), HHS issued a notice entitled, Solicitation of Proposals for New and Modified Safe Harbors and Special Fraud Alerts. In accordance with section 205 of the Health Insurance Portability and Accountability Act of 1996 (HIPAA), this annual notification solicits proposals and recommendations for developing new, or modifying existing, safe harbor provisions under section 1128B(b) of the Social Security Act (the Act), the Federal anti-kickback statute, as well as developing new OIG Special Fraud Alerts.

Event Notices

• December 4 and 5, 2023: The National Institutes of Health (NIH) announced a meeting of the Eunice Kennedy Shriver National Institute of Child Health and Human Development. The meeting will be videocast and is open to the public.
• December 5, 2023: The Health Resources and Services Administration (HRSA) announced the Maternal and Child Health Bureau Office of Epidemiology and Research, Division of Research is hosting the next Engaging Research Innovations & Challenges (EnRICH) webinar entitled, The National Survey of Children’s Health: New Data, Opportunities, and Directions. This is a virtual meeting open to the public.
• December 5 and 6, 2023: HRSA announced a meeting of the Advisory Committee on Infant and Maternal Mortality (ACIMM). This is a hybrid meeting open to the public.
• December 6, 2023: SAMHSA announced a meeting of the Interdepartmental Substance Use Disorders Coordinating Committee (ISUDCC). The meeting will include reports from the ISUDCC working groups and discussion of the ISUDCC’s recommendations to HHS on how the federal government can further integrate and coordinate harm reduction approaches and strategies across the continuum of prevention, treatment, and recovery policies, programs, and practices. This is a virtual meeting open to the public.
• December 6, 2023: VA announced a meeting of the National Research Advisory Council. This meeting is open to the public and will include time reserved for public comment at the end of the meeting.
• December 6, 2023: HHS announced a meeting of the Presidential Advisory Council on HIV/AIDS (PACHA). This is a hybrid meeting open to the public.
• December 6-7, 2023: HRSA announced a meeting of the National Advisory Council on Nurse Education and Practice. This is a hybrid meeting open to the public.
• December 7, 2023: NIH announced the National Heart, Lung, and Blood Institute will hold a meeting to update their Advisory Board and public stakeholders on research agendas across NIH for fiscal year (FY) 2024. This is a virtual public meeting that requires registration to attend.
• December 7, 2023: CDC announced Advisory Board on Radiation and Worker Health, National Institute for Occupational Safety and Health will hold a meeting open to the public.
• December 8, 2023: NIH announced the Muscular Dystrophy Coordinating Committee will hold a meeting, The meeting will bring together committee members, representing government agencies, patient advocacy groups, other voluntary health organizations, and patients and their families to update one another on progress relevant to the Action Plan for the Muscular Dystrophies and to coordinate activities and discuss gaps and opportunities leading to better understanding of the muscular dystrophies, advances in treatments, and improvements in patients’ and their families’ lives.
• December 12 and 13, 2023: CDC announced the Advisory Council for the Elimination of Tuberculosis (ACET) will hold a meeting open to the public.
• December 13 and 14, 2023: HHS announced it will hold a virtual public town hall meeting to discuss FY 2025 applications for add-on payments for new medical services and technologies under the hospital inpatient prospective payment system (IPPS).
• December 14 and 15: NIH announced a meeting of the Advisory Committee to the Director, National Institutes of Health. This is a hybrid meeting open to the public.
• December 20: HHS announced a meeting of the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria. This is a virtual meeting open to the public.
• January 24, 2024: NIH announced the Interagency Autism Coordinating Committee will hold a meeting to discuss committee business, updates, and issues related to autism research and services activities. This is a hybrid meeting open to the public.
• January 29, 2024: NIH announced the National Heart, Lung, and Blood Institute Sickle Cell Disease Advisory Committee will hold a virtual meeting open to the public.
• February 2, 2023: FDA announced the Anesthesiology and Respiratory Therapy Devices Panel of the Medical Devices Advisory Committee will hold a meeting that is open to the public.
• February 6, 2024: FDA announced the General Hospital and Personal Use Devices Panel of the Medical Devices Advisory Committee hill hold a meeting that is open to the public.

II. Hearings & Markups

U.S. House of Representatives

• On November 29, 2023, the House Committee on Energy and Commerce Health Subcommittee held a hearing entitled, Understanding How AI is Changing Health Care. Witnesses present included Dr. Michael Schlosser, M.D., MBA, Senior Vice President of Care Transformation and Innovation, HCA Healthcare; Dr. Benjamin Nguyen, Senior Product Manager, Transcarent; Mr. Peter Shen, Head of Digital Health – North America, Siemens Healthineers; Dr. Christopher Longhurst, M.D., Chief Medical Officer, Chief Digital Officer, and Association Dean, University of California,  San Diego (UCSD) Health; and, Dr. David Newman-Toker, M.D., Ph.D., Director, Division of Neuro-Visual and Vestibular Disorders, Department of Neurology, Professor of Neurology, Johns Hopkins University School of Medicine.
• On November 30, 2023, the House Committee on Energy and Commerce Oversight and Investigations Subcommittee held a hearing entitled, Unmasking Challenges CDC Faces in Rebuilding Public Trust Amid Respiratory Illness Season. The Director of the CDC, Honorable Mandy Cohen, was the sole witness.

III. Reports, Studies, & Analyses

• On November 28, 2023, OIG released a report entitled, Multiple States Made Medicaid Capitation Payments to Managed Care Organizations (MCO) After Enrollees’ Deaths. The report compiles fourteen previous OIG audits of state Medicaid agencies that revealed states were continuing to make capitated payments to MCOs after enrollees’ deaths. The report found that, across the fourteen audits, the states made over $249 million ($172 million of which were federal funds) in unallowable payments on behalf of deceased enrollees from July 1, 2009, to December 31, 2019. The report recommends that CMS (1) collect outstanding unallowable payments from MCOs, (2) ensure states comply with OIG’s previous recommendations in its individual state audits, and (3) continue exploring opportunity for stronger data oversight in Medicaid.
• On November 27, 2023, OIG released a report entitled, The Risk of Misuse and Diversion of Buprenorphine for Opioid Use Disorder in Medicare Part D Continues to Appear Low: 2022. OIG conducted an evaluation examining the use of buprenorphine in Medicare Part D in 2021 and found that buprenorphine's risk of misuse and diversion appeared to be low. According to the report, in 2021 almost all Medicare Part D enrollees who received buprenorphine for the treatment of Opioid Use Disorder (OUD) received the recommended amounts in 2022 and most enrollees received buprenorphine-naloxone combination products which are generally recommended to minimize the risk of misuse or diversion. Additionally, the report found that enrollees rarely received either very high amounts of buprenorphine or received buprenorphine at the same time as they received high amounts of other opioids. OIG found similar findings in its 2022 update, which suggests that the risk of misuse and diversion of buprenorphine in Medicare Part D continues to be low. These updated data provide important information about buprenorphine utilization that can assist CMS, HHS, and others as they continue to take steps to improve access to buprenorphine, while also ensuring that the risk of misuse and diversion remains low.
• On December 1, 2023, OIG released a report entitled, The Fall 2023 Semiannual Report to Congress (SAR). The report highlights OIG’s achievements in FY 2023, namely that over $3.44 billion are expected in recoveries as a result of OIG audits and investigations. The report overviews the enforcement actions taken against individuals and entities as a result of OIG investigations in FY 2023. Specifically, it highlights the 707 criminal enforcement actions for those involved in crimes targeting HHS and its beneficiaries, 746 civil actions taken, and 2,112 individuals and entities that were excluded from participating in federal health care programs. The report highlights notable OIG investigations including findings of overpayment in Medicare, disparities in access for opioid use disorder (OUD) among Medicaid beneficiaries, and failures of CMS public reporting on health and safety measurements among nursing homes.

IV. Other Health Policy News

• On November 27, 2023, Senate Majority Leader Chuck Schumer (D-NY) sent a Dear Colleague letter outlining his plan for the final work period of the first session of the 118th Congress. The letter outlines the Senate’s remaining priorities, including negotiations on long-term government funding, national security supplemental funding, the National Defense Authorization Act (NDAA), and other bipartisan legislation. It also confronts Senator Tommy Tuberville’s (R-AL) blockage of military promotions, and highlights Senator Schumer’s plan to confirm more of President Biden’s nominees to the federal bench. The Dear Colleague letter is available here.
• On November 27, 2023, the Biden Administration announced a list of steps it is taking to help strengthen the supply chain and domestic manufacturing and reduce shortages. The announcement was made during the inaugural meeting of a new White House Council on Supply Chain Resilience. President Biden will broaden HHS authorities under the Defense Production Act (Title III) to boost domestic manufacturing of essential medicines, medical countermeasures, and other critical inputs deemed by the President as essential to national defense. HHS has identified $35 million for investments in domestic production of key starting materials for sterile injectable medicines, which will help ensure the U.S. has all the tools and resources necessary to prepare for, respond to, and recover from future pandemics and other public health emergencies. Additionally, the Administration for Strategic Preparedness and Response (ASPR) and the U.S. Department of Commerce will partner to assess the U.S. Public Health Industrial Base supply chain to identify and address points of failure in the supply chain, focusing on supplies critical for the manufacturing of the influenza vaccine, FDA-designated essential medicines, and high-consequence biological medical countermeasures. HHS will also designate a new Supply Chain Resilience and Shortage Coordinator responsible for coordinating efforts to advance the resilience of medical product and food supply chains and accelerate responses to related shortages. A press release with more information is available here. A fact sheet outlining the Biden Administration’s actions is available here.
• On November 29, 2023, CMS announced an extension of the application deadline for the Making Care Primary (MCP) Model until December 14, 2023. The MCP Model is a voluntary, 10.5-year, multi-payer model that will run from July 2024 to December 2034, building on previous Centers for Medicare and Medication Innovation (CMMI) primary care models. Practices eligible to participate must be Medicare-enrolled, be the “regular source” of primary care for at least 125 attributed Medicare beneficiaries and must have the majority of their primary care sites within one of the following states: Colorado, Massachusetts, Minnesota, New Mexico, New Jersey, upstate New York, North Carolina, and Washington. MCP is intended to provide a pathway for primary care physicians with varying levels of experience in alternative payment models (APMs) and value-based care. One specific element of this model is its focus on practices that have not previously participated in value-based care arrangements, including those that support underserved communities and are small, independent, or rural. The goal is to support these practices in the gradual adoption of population-based payments and in delivering advanced primary care. More information on the MCP Model is available here.
• On November 29, 2023, Representative Frank Pallone (D-NJ-6), who serves as the Ranking Member of the Energy and Commerce Committee, sent a letter of support to the Biden Administration for their recent legal actions to bolster the No Surprises Act (NSA). The letter supports the Biden Administrations decision to exercise its enforcement discretion of the NSA in the wake of the ruling from the U.S. District Court for the Eastern District of Texas in Texas Medical Association et al. v. United States Department of Health and Human Services et al. (TMA III). The letter also supports the Biden Administration’s appeal of the TMA III decision. The Court in TMA III vacated certain provisions of CMS’ interim rules and guidance documents, including striking down how CMS calculates the Qualified Payment Amount (QPA) as outlined in their July 2021 interim final rule. The letter applauds CMS’ decision to exercise enforcement discretion, given the expectation the Administration will succeed in its appeal on the QPA methodology. The letter is available here.

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