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 of Representatives passed a “minibus,” finalizing fiscal year (FY) 2024 funding for six appropriations bills, and HHS issued a request for information (RFI) on private equity’s involvement in health care.

I. Regulations, Notices & Guidance

• On March 4, 2024, the Centers for Medicare & Medicaid Services (CMS) released a notice entitled, Clinical Laboratory Improvement Amendments of 1988 (CLIA) Fees; Histocompatibility, Personnel, and Alternative Sanctions for Certificate of Waiver Laboratories; Correction. This document corrects technical and typographical errors in the final rule that appeared in the December 28, 2023, Federal Register entitled, “Clinical Laboratory Improvement Amendments of 1988 (CLIA) Fees; Histocompatibility, Personnel, and Alternative Sanctions for Certificate of Waiver Laboratories”.
• On March 4, 2024, the Health Resources and Services Administration (HRSA) released a notice entitled, Request for Information: Nomination and Evidence-based Review Process of the Advisory Committee on Heritable Disorders in Newborns and Children. At the request of the Advisory Committee on Heritable Disorders in Newborns and Children (ACHDNC), HRSA is requesting input from the public on the process used by the Committee for nomination and evidence-based review of conditions that are considered for inclusion in the Recommended Uniform Screening Panel (RUSP). As an entity that advises the Secretary of Health and Human Services (HHS) based on evidence-based information, ACHDNC periodically considers and evaluates its processes. During the November 2023 meeting, ACHDNC hosted listening sessions to learn more from stakeholders regarding their views on the process used by ACHDNC for nomination and evidence-based review of conditions. In support of this work, HRSA is seeking public input on a series of questions that will help inform the nomination and review processes.
• On March 5, 2024, the Agency for Healthcare Research and Quality (AHRQ) released a notice entitled, Common Formats for Patient Safety Data Collection. As authorized by the HHS Secretary, AHRQ coordinates the development of common definitions and reporting formats for reporting on health care quality and patient safety. The purpose of this notice is to announce the availability of Common Formats for Surveillance – Hospital Version 1.0 for public review and comment.
• On March 5, 2024, CMS released a notice entitled, Medicare Program; Announcement of the Re-Approval of COLA under the Clinical Laboratory Improvement Amendments of 1988. This notice announces the application of the Commission on Office Laboratory Accreditation (COLA) for re-approval as an accreditation organization for clinical laboratories under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) program for the following specialty and subspecialty areas under CLIA: microbiology, including bacteriology, mycobacteriology, mycology, parasitology, and virology; diagnostic immunology, including syphilis serology, and general immunology; chemistry, including routine chemistry, toxicology, and endocrinology; hematology, including routine hematology and coagulation; immunohematology, including ABO Group, D (Rho) typing, unexpected antibody detection, compatibility testing, and antibody identification; pathology, including histopathology, oral pathology, and cytology. CMS has determined that COLA meets or exceeds the applicable CLIA requirements. CMS is announcing the re-approval and grant COLA deeming authority for a period of six years.
• On March 5, 2024, the Food and Drug Administration (FDA) released a notice entitled, Advisory Committee; Genetic Metabolic Diseases Advisory Committee; Addition to List of Standing Committees. FDA is amending the standing advisory committee regulations to add the establishment of the Genetic Metabolic Diseases Advisory Committee (GeMDAC) to the list of standing committees.
• On March 5, 2024, FDA released a notice entitled, Dietary Supplements: New Dietary Ingredient Notification Procedures and Timeframes: Guidance for Industry; Availability. The guidance focuses on frequently asked questions about the new dietary ingredient notification submission and review process. The guidance is intended to help manufacturers and distributors of new dietary ingredients and dietary supplements prepare and submit new dietary ingredient notifications to FDA.
• On March 5, 2024, HRSA released a notice entitled, National Vaccine Injury Compensation Program: Revised Amount of the Average Cost of a Health Insurance Policy. HRSA is publishing an updated monetary amount of the average cost of a health insurance policy as it relates to the National Vaccine Injury Compensation Program (VICP).
• On March 6, 2024, the Centers for Disease Control and Prevention (CDC) released a notice entitled, Reorganization of the National Institute for Occupational Safety and Health. CDC has modified its structure. This notice announces the reorganization of the World Trade Center (WTC) Health Program within the National Institute for Occupational Safety and Health (NIOSH). The WTC Health Program has established three branches.
• On March 6, 2024, FDA released a notice entitled, Advisory Committee; Gastrointestinal Drugs Advisory Committee; Renewal. FDA is announcing the renewal of the Gastrointestinal Drugs Advisory Committee by the Commissioner of Food and Drugs (the Commissioner). The Commissioner has determined that it is in the public interest to renew the Gastrointestinal Drugs Advisory Committee for an additional two years beyond the charter expiration date. The new charter will be in effect until it expires on March 3, 2026.
• On March 6, 2024, FDA released a notice entitled, Q2(R2) Validation of Analytical Procedures and Q14 Analytical Procedure Development; International Council for Harmonisation; Guidances for Industry; Availability. FDA is announcing the availability of final guidances for industry entitled “Q2(R2) Validation of Analytical Procedures” and “Q14 Analytical Procedure Development.” The guidances were prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The guidance entitled “Q2(R2) Validation of Analytical Procedures” provides a general framework for the principles of analytical procedure validation, including validation principles that cover the analytical use of spectroscopic data. The guidance entitled “Q14 Analytical Procedure Development” provides harmonized guidance on scientific approaches for analytical procedure development and describes principles to facilitate more efficient, science-based, and risk-based postapproval change management. The guidances are intended to facilitate regulatory evaluations and potential flexibility in postapproval change management of analytical procedures when scientifically justified.
• On March 7, 2024, CDC released a notice entitled, Clinical Laboratory Improvement Advisory Committee; Notice of Charter Renewal. CDC announced the renewal of the charter of the Clinical Laboratory Improvement Advisory Committee (CLIAC).
• On March 8, 2024, FDA released a notice entitled, Revocation of Emergency Use of a Drug Product During the COVID-19 Pandemic; Availability. FDA is announcing the revocation of the Emergency Use Authorization (EUA) (the Authorization) issued to Eli Lilly and Co. (Lilly), for bamlanivimab and etesevimab administered together. FDA revoked the Authorization on December 14, 2023, under the Federal Food, Drug, and Cosmetic Act (FD&C Act). The revocation, which includes an explanation of the reasons for the revocation, is reprinted in the notice.

Event Notices

March 13, 2024: The National Institutes of Health (NIH) announced a meeting of the National Cancer Institute Clinical Trials and Translational Research Advisory Committee. This is a virtual meeting open to the public.

March 13, 2024: CDC announced a meeting of the Board of Scientific Counselors, National Institute for Occupational Safety and Health. This is a virtual meeting open to the public.

March 13, 2024: FDA announced a meeting of the Oncologic Drugs Advisory Committee. This is a virtual meeting open to the public.

March 14, 2024: CDC announced a meeting of the Subcommittee on Procedures Reviews (SPR) of the Advisory Board on Radiation and Worker Health. This is a virtual meeting open to the public.

March 14, 2024: HRSA announced a meeting of the National Advisory Council for Healthcare Research and Quality. This is a virtual meeting open to the public.

March 18, 2024: NIH announced a meeting of the Muscular Dystrophy Coordinating Committee. This is a virtual meeting open to the public.

March 19, 2024: CDC announced a meeting of the ICD-10 Coordination and Maintenance Committee. This is a virtual meeting open to the public.

March 20, 2024: NIH announced a meeting of the National Cancer Institute Board of Scientific Advisors. This is a virtual meeting open to the public.

March 20, 2024: HHS announced a meeting of the Secretary’s Advisory Committee on Human Research Protections. This is a virtual meeting open to the public.

March 21, 2024: The Administration for Community Living (ACL) announced a meeting of the President’s Committee for People with Intellectual Disabilities. This is a virtual meeting open to the public.

March 21, 2024: FDA announced a meeting of the Ophthalmic Devices Panel of the Medical Devices Advisory Committee. This is a virtual meeting open to the public.

March 22, 2024: NIH announced a meeting of the National Advisory Child Health and Human Development Council Task Force on Research Specific to Pregnant Women and Lactating Women (PRGLAC) Implementation Working Group. This is a hybrid meeting open to the public.

March 25, 2024: NIH announced a meeting of the Center for Scientific Review Advisory Council. This is a hybrid meeting open to the public.

March 25-26, 2024: HHS announced a meeting of the Physician-Focused Payment Model Technical Advisory Committee (PTAC). This is a hybrid meeting open to the public.

March 27, 2024: The Substance Abuse and Mental Health Services Administration (SAMHSA) announced a meeting of the Interdepartmental Serious Mental Illness Coordinating Committee. This is a hybrid meeting open to the public.

April 4-5, 2024: NIH announced a meeting of the Sleep Disorders Research Advisory Board. This is a hybrid meeting open to the public.

April 5, 2024: HHS announced a meeting of the Office of Global Affairs on Public Health Emergencies Preparedness and Response Negotiations. This is a virtual meeting open to the public.

April 9, 2024: NIH announced a meeting of the Advisory Committee on Research on Women’s Health. This is a hybrid meeting open to the public.

April 10, 2024: CDC announced a meeting of the Clinical Laboratory Improvement Advisory Committee. This is a virtual meeting open to the public.

April 9-11, 2024: HRSA announced a meeting of the National Advisory Committee on Rural Health and Human Services. This is a hybrid meeting open to the public.

April 17, 2024: CDC announced a meeting of the Advisory Board on Radiation and Worker Health, National Institute for Occupational Safety and Health. This is a hybrid meeting open to the public.

April 17, 2024: CDC announced a meeting of the Community Preventative Services Task Force. This is a virtual meeting open to the public.

May 9, 2024, FDA announced a meeting of the Blood Products Advisory Committee. This is a virtual meeting open to the public.  

II. Hearings & Markups

House of Representatives

• On March 6, 2024, the House Ways and Means Committee held a markup of three bills: H.R. 7513, the Protecting America’s Seniors’ Access to Care Act; H.R. 5074, the Kidney PATIENT Act of 2023; and H.R. 7512, The Real-Time Benefit Tool Implementation Act.

Senate

• On March 6, 2024, the Senate Budget Committee held a hearing entitled, How Primary Care Improves Health Care Efficiency. Witnesses present included: Mr. Christopher Koller, President, Milbank Memorial Fund; Dr. Amol Navathe, Associate Professor, Perelman School of Medicine & the Wharton School, University of Pennsylvania; Dr. Bob Rauner, President, Partnership for a Healthy Nebraska & Representative, American Academy of Family Physicians; Ms. Lisa M. Grabert, Visiting Research Professor, Marquette University College of Nursing; and, Dr. Christina Taylor, Chief Medical Officer, Value Based Care, Clover Health, & President-elect, Iowa Medical Society.
• On March 7, 2024, the Senate Health, Education, Labor, and Pensions (HELP) Committee held a hearing entitled, The Older Americans Act: Supporting Efforts to Meet the Needs of Seniors. Witnesses present included: Ramsey Alwin, President and CEO, National Council on Aging; Ellie Hollander, President and CEO, Meals on Wheels America; Michelle Branham, Secretary, Florida Department of Elder Affairs; Martha (Marti) Y. Kubik, PhD, RN, FAAN, Professor of Nursing, College of Public Health, George Mason University; Dorothy Hutchins, Virginia Older Adult; and, Alison Barkoff, Principal Deputy Administrator and performing the duties of the Administrator and Assistant Secretary for Aging, Administration for Community Living, HHS.

III. Reports, Studies, & Analyses

• On March 4, 2024, the Congressional Research Service (CRS) released a report entitled, Connecting Older Adults to Information on Benefits and Services. The purpose of this report is to aid Members of Congress and their staff in assisting older adults with inquiries regarding federal benefits, programs, and services. It organizes information by subject matter such as elder justice, employment, food assistance, etc. Additionally, the report includes descriptions of federally funded referral services and key federal programs relevant to older adults. While not exhaustive, it provides a comprehensive overview of resources available and eligibility criteria.
• On March 7, 2024, the Office of the Inspector General (OIG) released a report entitled, HRSA Made Some Potential Overpayments to Providers Under the Phase 2 General Distribution of the Provider Relief Fund Program. OIG conducted an audit to ensure the accuracy and validity of Provider Relief Fund (PRF) payments distributed under the Phase 2 General Distribution during the COVID-19 pandemic. Out of a sample of 150 providers, OIG found errors in the calculation or documentation of PRF payments for 17 providers, resulting in $18.4 million in potential overpayments. These errors were attributed to inadequate procedures in processing and reviewing PRF applications, such as the omission of documentation requirements for revenue from patient care. OIG made recommendations to HRSA to address these issues and safeguard taxpayer funds in future emergency situations, with HRSA partially concurring and providing plans for corrective actions.
• On March 8, 2024, the Kaiser Family Foundation (KFF) released a report entitled, Access to Adult Dental Care Gets Renewed Focus in ACA Marketplace Proposal. Currently, adult dental care is prohibited as being considered an essential health benefit (EHB) in individual and small group markets. Conversely, children’s dental coverage is considered an EHB under the Affordable Care Act (ACA) statute. The proposed 2025 Notice of Benefit and Payment Parameters (NBPP) proposes removing the prohibition on classifying adult dental care as an EHB. KFF’s highlights its previous findings in the KFF Consumer Survey of Consumer Experiences with Health Insurance which found that one in four adults with health insurance had cost barriers to accessing dental benefits. However, Marketplace enrollees report enhanced barriers to dental care due to cost concerns. Notably, 39 percent and 37 percent of people covered by Medicaid and Marketplace care, respectively, reported delaying or forging dental care because of cost concerns, compared to 28 percent of adults with health insurance. The report notes that the NBPP proposal could present issues, including increasing costs for the federal government and insurer and imposing cost-sharing on consumers.  for dental services.

IV. Other Health Policy News

• On March 4, 2024, the Biden-Harris Administration announced it received counteroffers from drug companies in response to negotiations aimed at lowering drug prices under the Inflation Reduction Act (IRA). HHS Secretary Xavier Becerra expressed optimism about the ongoing talks, emphasizing the Administration’s commitment to reducing costs for Americans. CMS Administrator Chiquita Brooks-LaSure highlighted the significance of reaching this milestone in negotiations, emphasizing the aim to improve access to expensive drugs for people with Medicare. Negotiations will continue in the coming months, with new negotiated prices expected to be published by September 1, 2024. A press release with more information is available here.
• On March 4, 2024, a group of ten Democratic Senators, led by Senators Elizabeth Warren (D-MA) and Sherrod Brown (D-OH), sent a letter to HHS and CMS, calling on the Administration to improve beneficiary coverage and reduce taxpayer costs in Medicare Advantage (MA). The letter notes that, on average, CMS pays six percent more per MA enrollee than the agency would pay to cover the same enrollee in traditional Medicare (TM). Furthermore, the Senators say that MA plans frequently deny or delay medically necessary care. The letter calls on CMS to incorporate MA reforms in the Calendar Year (CY) 2025 Advance Notice that make it easier for MA beneficiaries receive care, ensure MA funds are being invested in patients and providers, and modernize TM benefits. Specifically, the letter calls on CMS and HHS to:

1. “Prevent insurance companies from imposing barriers to care, such as onerous prior authorizations, Artificial Intelligence (AI) algorithms, or limited networks;
2. Strengthen transparency to improve public understanding of the effects of insurer-run Medicare Advantage plans on patients and the Medicare program;
3. Crack down on upcoding and other deceptive tactics to rein in overpayments to insurance companies in MA;
4. Address misleading and deceptive marketing practices; and
5. Use administrative action to strengthen TM.”

• The full letter is available here.
• On March 5, the White House announced the Strike Force on Unfair and Illegal Pricing, which will tackle “corporate rip-offs and other unfair practices that keep prices high” in health care, the prescription drug market, and other consumer sectors, such as housing and food. The task force will be co-chaired by representatives from the Department of Justice (DOJ) and the Federal Trade Commission (FTC) and will be an interagency effort to prevent and stop illegal corporate behaviors that increase prices, such as anti-competitive, deceptive, or fraudulent business practices. The announcement says the task force will build upon the existing efforts of the White House Competition Council, including their work on march-in rights, MA marketing tactics, and privacy protections. The announcement comes shortly after the White House appointed its inaugural HHS Chief Competition Office, another effort to lower health care costs.
• On March 5, 2024, the Justice Department’s Antitrust Division, FTC, and HHS announced the launch of a cross government inquiry into private equity and other corporations’ control over health care. The agencies issued a Request for Information (RFI) to request public comment on various deals involving healthcare providers, facilities, and services. The RFI specifically targets transactions that may not be subject to antitrust review under existing laws. Stakeholders, including patients, healthcare workers, and market participants, are encouraged to contribute their perspectives. The feedback received will inform the agencies’ enforcement strategies and potential regulatory actions aimed at fostering competition and ensuring access to quality, affordable healthcare services. The public has 60 days to submit comments through Regulations.gov, until May 6. A press release with more information is available here. The RFI is available here.
• On March 6, 2024, the House passed its fourth short-term continuing resolutions for fiscal year (FY) 2024 to complete its appropriations for six of the 12 spending bills. The Senate is also expected to advance the package, preventing a partial government shutdown. An agreement was reached over the weekend on funding for the remainder of the FY24 for six appropriation bills, including the Agriculture/FDA appropriations. HHS is not included in this package, but many health extenders are included. These health extensions include:

• • Extending funding for Medicare-dependent hospital and low-volume hospital programs through December 2024;
  • Extending funding for community health centers, the National Health Service Corps (NHSC), and Teaching Health Centers Graduate Medical Education (THCGME) through December 2024;
  • Reducing a scheduled Medicare physician payment, retroactive to January 1, 2024; and
  • Eliminating the scheduled Medicaid Disproportionate Share Hospital (DSH) cut for FY2024.
• On March 6, 2024, the White House released a fact sheet detailing the Biden Administration’s health care priorities ahead of the President’s State of the Union Address on March 7, 2024. Key successes outlined in the fact sheet include:
  • Enabling Medicare to negotiate drug prices;
  • Implementing caps on out-of-pocket costs for prescription drugs in Medicare including insulin;
  • Expanding mental health coverage through finalizing the mental health parity rule and expanding access to mental health and behavioral health services in Medicare and private insurance; and,
  • Efforts to address surprise medical bills for ground ambulance providers.
• Additionally, the Administration expressed its intent to strengthen Medicare through continuous enrollment efforts, enhance healthcare quality standards, and expand healthcare coverage nationwide. The fact sheet is available here.
• On March 7, 2024, President Biden gave his State of the Union address. President Biden addressed rising health care costs and improving access to quality care. In addition, he highlighted the success of the IRA in reducing prescription drug costs, particularly for seniors on Medicare, by capping monthly insulin costs at $35 and yearly prescription drug costs at $2,000. President Biden underscored the importance of extending these benefits to all Americans and proposed expanding Medicare’s authority to negotiate lower drug prices for 500 medications over the next decade, projecting significant savings for both seniors and taxpayers. Further, President Biden reiterated his commitment to protecting and strengthening the ACA, emphasizing provisions such as coverage for pre-existing conditions and enhanced subsidies to make healthcare more affordable for millions. A recording of the State of the Union Address is available here. President Biden’s speech as prepared for delivery is available here.
• On March 7, 2024, the Biden Administration, through HRSA, unveiled a nearly $50 million initiative to support opioid treatment and recovery services in rural communities. Funding will be prioritized for increasing access to medications for opioid use disorder (OUD), such as buprenorphine, and addressing the unique challenges rural communities face including geographic isolation and limited healthcare providers. HRSA’s Rural Opioid Treatment and Recovery Initiative emphasizes a comprehensive approach that encompasses workforce development, recovery support, transportation, employment, and other essential services. The initiative encourages local solutions tailored to rural communities’ specific needs, with funding supporting activities like mobile units for medication distribution and integration of treatment into primary care settings. Applicants are encouraged to incorporate supportive services and address social determinants of health (SDOH), with a focus on overcoming transportation barriers. The funding opportunity, with an average award expected to be up to $750,000 per year over four years, is open for applications until May 6, 2024, accessible through grants.gov. A press release with more information is available here.

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