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 passed an appropriations bill to fund HHS and other agencies for the remainder of fiscal year (FY) 2024, with the Senate expected to vote shortly, and CMS introduced the ACO Primary Care Flex Model.

I. Regulations, Notices & Guidance

• On March 19, 2024, the Centers for Disease Control and Prevention (CDC) released a notice entitled, Reorganization of the Office of Safety, Security and Asset Management. This notice announces the reorganization of the Office of Safety, Security and Asset Management (OSSAM).
• On March 19, 2024, the Food and Drug Administration (FDA) released a proposed rule entitled, 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. FDA proposed to establish criteria for the lists of drug products or categories of drug products that present demonstrable difficulties for compounding (Demonstrable Difficulties for Compounding Lists or (“DDC Lists”)) under certain sections of the Federal Food, Drug, and Cosmetic Act (FD&C Act). Drug products or categories of drug products that appear on the DDC Lists cannot qualify for certain statutory exemptions, and therefore may not be compounded under, either section 503A or section 503B, respectively.
• On March 19, 2024, the Health Resources and Services Administration (HRSA) released a notice entitled, Statement of Organization, Functions, and Delegations of Authority. This notice states that HRSA will reorganize sections of the Office of Special Health Initiatives, Office of Operations, Office of Intergovernmental and External Affairs, and Office of Federal Assistance Management, which are agencies within HRSA. These reorganization updates realigns functions, including delegations of authority for the: (1) Office of Special Health Initiatives, (2) Office of Operations, (3) Office of Intergovernmental and External Affairs, and (4) Office of Federal Assistance Management.
• On March 19, 2024, the Indian Health Service (IHS) released a notice entitled, Native Public Health Resilience. IHS announced that it is accepting grant applications for Native Public Health Resilience. This program is authorized under the Snyder Act, 25 U.S.C. 13; the Transfer Act, 42 U.S.C. 2001(a); and the American Rescue Plan Act, Public Law No. 117-2, 135 Stat. 42 (2021).
• On March 19, 2024, IHS released a notice entitled, Native Public Health Resilience Planning. IHS announced that it is accepting applications for grants for Native Public Health Resilience Planning. This program is authorized under the Snyder Act, 25 U.S.C. 13; the Transfer Act, 42 U.S.C. 2001(a); and the American Rescue Plan Act, Public Law No. 117-2, 135 Stat. 42 (2021).
• On March 20, 2024, the Executive Office of the President (EOP) released an executive order entitled, Advancing Women's Health Research and Innovation. This executive order announced an investment of $12 billion in new funding for women’s health research. This investment would be used to create a Fund for Women’s Health Research at the National Institutes of Health (NIH) to advance a cutting-edge, interdisciplinary research agenda and to establish a new nationwide network of research centers of excellence and innovation in women’s health—which would serve as a national gold standard for women’s health research across the lifespan.
• On March 20, 2024, FDA released a notice entitled, Revocation of Six Authorizations of Emergency Use of In Vitro Diagnostic Device for Detection and/or Diagnosis of COVID-19; Availability. FDA announced the revocation of the Emergency Use Authorizations (EUAs) issued to Life Technologies Corp. (a legal entity of Thermo Fisher Scientific, Inc.), for the TaqPath COVID–19 Pooling Kit; Bio-Rad Laboratories, Inc., for the Reliance SARS–CoV–2 RT–PCR Assay Kit; Revvity, Inc., (on behalf of Revvity Omics (a Revvity, Inc. company that was a rebranding of PerkinElmer Genomics)), for the PerkinElmer SARS–CoV–2 RT–qPCR Reagent Kit; bioMérieux SA for the VIDAS SARS–CoV–2 IgM kit; bioMérieux SA for the VIDAS SARS–CoV–2 IgG kit; and Luminex Corp. for the xMAP SARS–CoV–2 Multi-Antigen IgG Assay. FDA revoked the Authorizations under the Federal Food, Drug, and Cosmetic Act as requested by the Authorization holder.
• On March 20, 2024, FDA released a notice entitled, Real-World Evidence: Considerations Regarding Non-Interventional Studies for Drug and Biological Products; Draft Guidance for Industry; Availability. FDA issued this draft guidance as part of a series of guidance documents under its Real-World Evidence (RWE) Program and to satisfy, in part, a mandate under the Federal Food, Drug, and Cosmetic Act to issue guidance about the use of RWE in regulatory decision-making. The draft guidance provides recommendations to sponsors who are considering submitting a non-interventional study, also referred to as an observational study, to FDA to contribute to a demonstration of substantial evidence of effectiveness and/or evidence of safety of a drug. This draft guidance was developed in response to stakeholders’ growing interest in the potential use of non-interventional studies to contribute to a demonstration of the effectiveness or safety of a drug.
• On March 20, 2024, FDA released a notice entitled, Eli Lilly and Company; Withdrawal of Approval of SARAFEM (Fluoxetine Hydrochloride) Capsules, Equivalent to 10 Milligrams Base and Equivalent to 20 Milligrams Base, Including the Premenstrual Dysphoric Disorder Indication Approved Under New Drug Application 018936. FDA withdrew approval of SARAFEM (fluoxetine hydrochloride (HCl)) capsules, equivalent to (EQ) 10 milligrams (mg) base and EQ 20 mg base, including the premenstrual dysphoric disorder (PMDD) indication, approved under new drug application (NDA) 018936. This NDA is held by Eli Lilly and Co.(Lilly). Lilly notified the Agency in writing that SARAFEM (fluoxetine HCl) capsules, EQ 10 mg base and EQ 20 mg base, indicated for the treatment of PMDD, was no longer marketed and requested that the approval of SARAFEM (fluoxetine HCl) capsules, including the PMDD indication, be withdrawn.
• On March 21, 2024, the Centers for Medicare & Medicaid Services (CMS) released a notice entitled, Medicare Program; Application by the Utilization Review Accreditation Commission (URAC) for Continued CMS Approval of its Home Infusion Therapy (HIT) Accreditation Program. This final notice announced CMS’s decision to approve the Utilization Review Accreditation Commission (URAC) for continued recognition as a national accrediting organization that accredits suppliers of home infusion therapy (HIT) services that wish to participate in the Medicare or Medicaid programs.
• On March 21, 2024, the National Institutes of Health (NIH) released a notice entitled, Prospective Grant of an Exclusive Patent License: Adoptive T Cell Therapy Products Produced Using a Pharmacological p38 Mitogen-Activated Protein Kinase (MAPK) Inhibitor. The National Cancer Institute, an institute of the NIH, is contemplating the grant of an Exclusive Patent License to practice the inventions embodied in the Patents and Patent Applications listed in the Supplementary Information section of this Notice to Poolbeg Pharma (UK) Limited, incorporated in the United Kingdom.
• On May 22, 2024, the Substance Abuse and Mental Health Services Administration (SAMHSA) released a notice entitled, Fiscal Year (FY) 2024 Funding Opportunity. SAMHSA announced that it intends to award up to $675,000 per year for up to five years to the Community-Based, Advocacy-Focused, Data-Driven, Coalition-Building Association (CADCA). The purpose of the award is to leverage existing resources to expand SAMHSA’s scope and prevention capacity; provide training and technical assistance to state and community prevention leaders, including members of anti-drug community coalitions from around the country who are committed to addressing the evolving needs of the behavioral health field; and to promote prevention workforce development. The training and workforce development activities supported through this cooperative agreement include SAMHSA’s Prevention Day and SAMHSA’s participation in the annual National Leadership Forum, the annual Mid-Year Training Institute of CADCA, and developing youth leaders across the three conferences/events listed above.

Event Notices

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: The Department of Health and Human Services (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: SAMHSA announced a meeting of the Interdepartmental Serious Mental Illness Coordinating Committee. This is a hybrid meeting open to the public.

April 2-4, 2024: HRSA announced a meeting of the Advisory Committee on Infant and Maternal Health. 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: NIH announced a meeting of the Interagency Autism Coordinating Committee. 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 6, 2024: CDC announced a meeting of the National Advisory Board on Medical Rehabilitation Research.

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

May 21, 2024: CMS announced a meeting of the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC). This is a virtual meeting open to the public.

May 21-22, 2024: HHS announced a meeting of the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria. This is a hybrid meeting open to the public.

II. HEARINGS & MARKUPS

House of Representatives

• On March 18, 2024, the House Committee on Ways and Means held a field hearing in Denton, Texas, entitled, Access to Health Care in America: Ensuring Resilient Emergency Medical Care. Witnesses included: Chloe Burke, emergency care patient; Dr. Edward Racht, M.D., Chief Medical Officer, Global Medical Response (GMR); Matt Zavadsky, Chief Transformation Officer, Medstar Mobile Healthcare; Ted Matthews, CEO of Anson General Hospital; Robert Morris, CEO of Complete Care; and, Lauren Miller, emergency care patient.
• On March 20, 2024, the House Committee on Ways and Means held a hearing entitled, Hearing with Health and Human Services Secretary Becerra. HHS Secretary Xavier Becerra was the sole witness.
• On March 20, 2024, the House Energy and Commerce Committee held a markup of 28 bills. The healthcare related bills included were: H.R. 619, the NAPA Reauthorization Act; H.R. 620, the Alzheimer’s Accountability and Investment Act; H.R. 7218, the Building Our Largest Dementia (BOLD) Infrastructure for Alzheimer's Act of 2024; H.R. 4581, the Maternal and Child Health Stillbirth Prevention Act of 2024; H.R. 2706, the Charlotte Woodward Organ Transplant Discrimination Prevention Act; H.R. 4646, the SIREN Reauthorization Act; H.R. 6160, To amend the Public Health Service Act to reauthorize a lifespan respite care program; H.R. 6960, the Emergency Medical Services for Children Reauthorization Act of 2024; H.R. 7153, the Dr. Lorna Breen Health Care Provider Protection Reauthorization Act; H.R. 7251, the Poison Control Centers Reauthorization Act of 2024; H.R. 7224, To amend the Public Health Service Act to reauthorize the Stop, Observe, Ask, and Respond to Health and Wellness Training Program; H.R. 7208, the Dennis John Beningo Traumatic Brain Injury Program Reauthorization Act of 2024; H.R. 6829, the Cardiomyopathy Health Education, Awareness, and Research, and AED Training in the Schools (HEARTS) Act of 2024; H.R. 7189, the Congenital Heart Futures Reauthorization Act of 2024; H.R. 7406, the DeOndra Dixon INCLUDE Project Act of 2024; H.R. 3916, the SCREENS for Cancer Act of 2024; and, H.R. 5074, the Kidney PATIENT Act. All 28 bills were ordered and reported favorably to the House.
• On March 21, 2024, the House Energy and Commerce Health Subcommittee held a hearing entitled, Evaluating Approaches to Diagnostic Test Regulation and the Impact of the FDA’s Proposed Rule. Witnesses included: Susan Van Meter, President, American Clinical Laboratory Association (ACLA); Zach Rothstein, JD, Executive Director, AdvaMedDx; Donald S. Karcher, MD, FCAP, President of the College of American Pathologists (CAP); Jeff Allen, PhD, President and CEO, Friends of Cancer Research; and Dara L. Aisner, MD, PhD, Medical Director, Colorado Molecular Correlates Laboratory, Professor of Pathology, University of Colorado and Representative of the Academic Coalition for Effective Laboratory Developed Tests.

III. Reports, Studies, & Analyses

• On March 19, 2024, the Office of Inspector General (OIG) released a report entitled, South Carolina MMIS and E&E System Security Controls Were Adequate, but Some Improvements Are Needed. OIG is conducting a series of audits of multiple State Medicaid Management Information Systems (MMIS) and Eligibility and Enrollment (E&E) systems to ascertain how the systems are protected in the case of a cyberattack. The report found that South Carolina’s MMIS and E&E system had adequate protections in place to prevent against the cyberattacks simulated by OIG. However, OIG noted that some security controls should be enhanced, including four security controls that South Carolina failed to implement even though they are required by the National Institute of Standards and Technology (NIST) Special Publication (SP) 800-53, Revision 5. Since this research began, South Carolina has remediated two of the four security control findings to meet government standards. Furthermore, OIG found that a cybersecurity adversary would need a moderate level of sophistication, at a minimum, to compromise South Carolina’s system. OIG recommended that South Carolina remediate the remaining two NIST control standards that it failed to meet.
• On March 20, 2024, the Congressional Budget Office (CBO) released a report entitled, The Long-Term Budget Outlook: 2024 to 2054. CBO projects a significant increase in the total federal budget deficit over the next 30 years, reaching 8.5 percent of gross domestic product (GDP) in 2054. According to the report, this level of deficit is driven by rising interest costs and sustained primary deficits, averaging 2.2 percent of GDP over the period. CBO states that the federal debt held by the public is forecasted to rise each year, reaching 107 percent of GDP by 2029 and peaking at 166 percent of GDP in 2054. Such high and growing debt levels are expected to slow economic growth, increase interest payments to foreign debt holders, and constrain policy choices for lawmakers. Federal outlays, as a percentage of GDP, are projected to increase steadily, reaching 27.3 percent of GDP by 2054. This growth is fueled by rising net interest costs and spending on federal health care programs, particularly Medicare. On the revenue side, receipts are expected to fluctuate over the next decade before increasing, reaching 18.8 percent of GDP by 2054, primarily due to income growth boosting individual income tax revenues. In CBO’s updated budget projections, federal debt in 2053 is now forecasted to be 17 percentage points smaller, and the total deficit in 2053 is projected to be 1.6 percentage points smaller compared to previous estimates. This reduction in projected deficits is attributed to decreases in discretionary spending, driven by annual funding limits imposed by recent legislation. Overall, CBO’s debt projections have increased through 2031 but decreased in later years.

IV. Other Health Policy News

• On March 19, 2024, CMS unveiled the ACO Primary Care (PC) Flex Model, a voluntary initiative designed to bolster access to high-quality primary care for underserved Medicare populations. This model empowers primary care providers within eligible Accountable Care Organizations (ACOs) to deliver innovative, team-based, person-centered proactive care. The model enhances primary care funding and incentivizes team-based approaches to medical and social needs. Operating within the Medicare Shared Savings Program (MSSP), the model prioritizes investment in low revenue ACOs, which have demonstrated potential for savings and quality improvement. By supporting these ACOs, the model seeks to promote competition and offer physicians a pathway to maintain independence while serving Medicare beneficiaries. Through the ACO PC Flex Model, ACOs will receive a one-time advanced shared savings payment and monthly prospective primary care payments (PPCPs). These payments aim to provide resources and flexibility to cover costs related to ACO formation and administrative activities, thereby enabling primary care practices to deliver customized care tailored to individuals' needs. It is anticipated to select approximately 130 ACOs for participation. Interested organizations, whether new or renewing ACOs, are encouraged to apply to the MSSP, with applications open from May 20, 2024, to June 17, 2024. The ACO PC Flex Model Request for Applications (RFA) is slated for release in the second quarter of 2024, providing comprehensive details and guidance for participation in this initiative. A press release with more information is available here.
• On March 22, 2024, HHS announced funding opportunities totaling $39.4 million to address behavioral health issues across the nation. These grants, administered by SAMHSA, align with the Biden Administration’s priorities to combat the overdose epidemic and tackle the mental health crisis, key components of the President's Unity Agenda. Miriam E. Delphin-Rittmon, Assistant Secretary for Mental Health and Substance Use at HHS, highlighted the broad range of support provided by SAMHSA grants, including primary and behavioral health care integration, substance use prevention and recovery, and support for individuals and families facing mental health challenges. The announced grant programs include initiatives such as the Building Communities of Recovery program, aimed at increasing access to recovery support services, and the Assisted Outpatient Treatment Program for Individuals with Serious Mental Illness, which supports the implementation of new Assisted Outpatient Treatment programs for adults with serious mental illness. Other programs include the Garrett Lee Smith Campus Suicide Prevention Grant Program, focused on enhancing behavioral health services for college students, and the Sober Truth on Preventing Underage Drinking Act (STOP Act) Grant Program, which aims to prevent and reduce alcohol use among youth and young adults. A press release with more information is available here.
• On March 22, 2024, the Biden Administration marked the 10-year anniversary of the Affordable Care Act (ACA) Marketplaces with the release of extensive enrollment data, showcasing significant strides in health insurance coverage. Reports from HHS revealed that over 21 million individuals opted for or were automatically enrolled in coverage during the 2024 Open Enrollment Period. Additionally, the data underscores the impact of the ACA, with over 45 million Americans now benefiting from coverage under ACA-related programs, including Medicaid expansion. The reports delve into enrollment trends across various demographic groups, highlighting increased coverage among historically underserved communities. Additionally, they shed light on the evolution of ACA Marketplaces over the past decade, emphasizing enhanced competition among insurers and crucial consumer protections introduced by the law, such as prohibiting denial of coverage based on pre-existing conditions and ensuring equitable premium rates regardless of gender or age. A press release with more information is available here.
• On March 22, 2024, the House of Representatives passed a ‘minibus’ that is set to fund the remaining six fiscal year (FY) 2024 appropriation bills, including funding for HHS and its programs. This $1.2 trillion deal, so called “2^nd Minibus”, will fund the remainder of the government for the rest of the fiscal year and follows four short term funding extensions since the start of the fiscal year. The package does not include many health care legislative priorities. The “1^st Minibus” passed two weeks ago and provided funding for six federal appropriations accounts including U.S. Department of Agriculture (USDA) where some rural health programs are housed. The 1^st Minibus included several health program extensions through the end of the calendar year, including funding for community health centers, National Health Service Corps, Teaching Health Center Graduate Medical Education (THCGME), and it extended the Medicare Dependent Hospital and Low Volume Hospital payment programs through January 1, 2025. Despite months of activity to advance additional hospital transparency requirements and site neutral payment reforms, neither bill included these proposals. The Senate is expected to finish their consideration of this package in the coming days. The bill text, summaries and congressional directed spending information can be found here.

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