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 Biden Administration submitted a $98.6 billion request to Congress for disaster relief and the Senate Health Care Cybersecurity Working Group proposed new health care cybersecurity legislation.
I. Regulations, Notices & Guidance
- On November 18, 2024, the Food and Drug Administration (FDA) released a draft guidance document entitled, Frequently Asked Questions--Developing Potential Cellular and Gene Therapy Products; Draft Guidance for Industry; Availability. This draft guidance document provides industry with answers to frequently asked questions (FAQs) and commonly faced issues that arise during the development of cellular and gene therapy (CGT) products. The FAQs represent common questions directed to the agency and span multiple disciplines, including regulatory review; chemistry, manufacturing, and controls (CMC); pharmacology/toxicology; clinical; and clinical pharmacology.
- On November 18, 2024, the National Institutes of Health (NIH) released a notice entitled, Office of the Director; Notice of Charter Renewal. Notice is hereby given that the charter for the National Toxicology Program Board of Scientific Counselors was renewed for an additional two-year period on November 14, 2024.
- On November 19, 2024, FDA released a notice entitled, Revocation of Two Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection and/or Diagnosis of COVID-19; Availability. FDA is announcing the revocation of the Emergency Use Authorizations (EUAs) (the Authorizations) issued to Cue Health, Inc., for the Cue COVID-19 Test, and Cue COVID-19 Test for Home and Over the Counter (OTC) Use. FDA revoked the Authorizations under the Federal Food, Drug, and Cosmetic Act (FD&C Act) as requested by the Authorization holder. The revocations, which include an explanation of the reasons for each revocation, are reprinted at the end of the document.
- On November 19, 2024, FDA released draft guidance entitled, Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability. This draft guidance provides product-specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs). In the Federal Register of June 11, 2010, FDA announced the availability of a guidance for industry entitled, Bioequivalence Recommendations for Specific Products that explained the process that would be used to make product-specific guidances available to the public on FDA’s website. The draft guidances identified in this notice were developed using the process described in that guidance.
- On November 19, 2024, FDA released a notice entitled, Statement of Organization, Functions, and Delegations of Authority. FDA’s Office of the Commissioner (OC), Office of Digital Transformation (ODT) has modified their organizational structure. The new organizational structure was approved by the Secretary of the Department of Health and Human Services (HHS) on September 20, 2024.
- On November 19, 2024, the Health Resources and Services Administration (HRSA) released a notice of supplemental funding entitled, Notice of Supplemental Funding; National Rural Health Information Clearinghouse Program. HRSA provided supplemental funds to the National Rural Health Information Clearinghouse Program recipient, University of North Dakota, to develop toolkits and other resources that address strategies to promote rural community health and support the improvement of health care in rural areas.
- On November 19, 2024, HRSA released a notice of supplemental funding entitled, Notice of Supplemental Funding; National Rural Health Policy, Community, and Collaboration Program. HRSA provided supplemental funds to the sole award recipient of the National Rural Health Policy, Community, and Collaboration Program to enhance rural health state partnerships, support ongoing work with technical assistance recipients, and work to support a toolkit designed to assist rural health networks.
- On November 19, 2024, HRSA released a notice of supplemental funding entitled, Notice of Supplemental Funding; Rural Health and Economic Development Analysis Program. HRSA provided supplemental funds to the sole award recipient of the Rural Health and Economic Development Analysis Program to support a research project that quantifies the relationships between health care and economic factors in rural communities.
- On November 19, 2024, NIH released a notice entitled, Prospective Grant of Exclusive License, Inter-Institutional Agreement-Institution Lead: Peptides And Peptide Microarrays For Detection And Differentiation Of Antibody Responses To Ebola Virus And Other Pathogens. The National Institute of Allergy and Infectious Diseases, an institute of NIH, HHS, is contemplating the grant of an exclusive, sublicensable patent license to The Trustees of Columbia University in the City of New York, Columbia Technology Ventures, located in New York, New York to practice the inventions embodied in the patent applications listed in the Supplementary Information section of this notice.
- On November 20, 2024, FDA released final guidance entitled, 510(k) Third Party Review Program and Third Party Emergency Use Authorization Review; Guidance for Industry, Food and Drug Administration Staff, and Third Party Review Organizations; Availability. This guidance provides FDA’s current thinking regarding the 510(k) Third Party (3P510k) Review Program and review of EUA requests by a third-party review organization (3PEUA review). The 3P510k Review Program and 3PEUA review create an alternative process for manufacturers to seek review of 510(k) submissions and EUA requests to assist FDA in reviewing in a timely manner.
- On November 20, 2024, HRSA released a notice entitled, Inclusion of Terrain Factors in the Definition of Rural Area for Federal Office of Rural Health Policy Grants. HRSA’s Federal Office of Rural Health Policy (FORHP) is modifying the definition of “rural area” for the purposes of determining geographic eligibility to apply for or receive services funded by FORHP’s rural health grants. With a data-driven methodology, this update to the definition of rural area will integrate the new Road Ruggedness Score (RRS) released in 2023 by the Economic Research Service of the U.S. Department of Agriculture. This notice responds to comments received on proposed modifications to HRSA’s FORHP definition published in the Federal Register on April 26, 2024.
- On November 21, 2024, FDA released final guidance entitled, Orthopedic Non-Spinal Bone Plates, Screws, and Washers - Premarket Notification (510(k)) Submissions; Guidance for Industry and Food and Drug Administration Staff; Availability. This final guidance document provides recommendations for information to include in 510(k) submissions for non-resorbable bone plate, screw, and washer devices. The scope of this guidance includes devices that are indicated for orthopedic bone fixation but does not include devices indicated for spinal, mandibular, maxillofacial, cranial, and orbital fracture fixation.
- On November 22, 2024, FDA released final guidance entitled, Orthopedic Non-Spinal Metallic Bone Screws and Washers - Performance Criteria for Safety and Performance Based Pathway: Guidance for Industry and Food and Drug Administration Staff. This guidance provides performance criteria for non-spinal metallic bone screws and their associated washers in support of the Safety and Performance Based Pathway. Under this framework, submitters planning to submit a 510(k) using the Safety and Performance Based Pathway for non-spinal metallic bone screws and washers will have the option to use the performance criteria proposed in this guidance to support substantial equivalence, rather than a direct comparison of the performance of the subject device to that of a predicate device. The recommendations are intended to promote consistency and facilitate efficient review of orthopedic non-spinal metallic bone screws and washers.
- On November 22, 2024, the Assistant Secretary for Technology Policy/Office of the National Coordinator for Health Information Technology (ASTP/ONC) released a notice entitled, Notice of Publication of Common Agreement for Nationwide Health Information Interoperability (Common Agreement) Version 2.1. This notice fulfills an obligation under the Public Health Service Act (PHSA). The Act requires the National Coordinator for Health Information Technology to publish on ONC’s public website, and in the Federal Register, the Trusted Exchange Framework and Common Agreement (TEFCA) developed under the PHSA. This notice is for publishing an updated version of the Common Agreement (Version 2.1).
Event Notices
December 2-3, 2024: NIH announced a meeting of the National Cancer Advisory Board (NCAB) and National Cancer Institute Board of Scientific Advisors (BSA). This is a hybrid meeting open to the public.
December 2-3, 2024: NIH announced a meeting of the National Advisory Board on Medical Rehabilitation Research. This is a hybrid meeting open to the public.
December 3, 2024: The Centers for Disease Control and Prevention (CDC) announced a meeting of the Advisory Council for the Elimination of Tuberculosis. This is a virtual meeting open to the public.
December 3, 2024: The Substance Abuse and Mental Health Services Administration (SAMHSA) announced a meeting of the Center for Substance Abuse Prevention’s Drug Testing Advisory Board. This is a virtual meeting open to the public.
December 3, 2024: NIH announced a meeting of the Novel and Exceptional Technology and Research Advisory Committee. This is a virtual meeting open to the public.
December 4, 2024: FDA announced a meeting of the Pharmacy Compounding Advisory Committee. This is a hybrid meeting open for public comment.
December 4, 2024: The Administration for Strategic Preparedness and Response (ASPR) announced a meeting of the National Advisory Committee on Children and Disasters. This is a virtual meeting open to the public.
December 5, 2024: NIH announced a meeting of the Sleep Disorders Research Advisory Board. This is a virtual meeting open to the public.
December 9, 2024: NIH announced a briefing on the National Academies of Science, Engineering, and Medicine’s (NASEM) Assessment of NIH Research on Women’s Health. This is a hybrid meeting open to the public.
December 10, 2024: ASPR announced a meeting of the National Advisory Committee on Individuals with Disabilities and Disasters. This is a virtual meeting open to the public.
December 11, 2024: CDC announced a meeting of the Lead Exposure and Prevention Advisory Committee. This is a virtual meeting open to the public.
December 12, 2024: 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 12, 2024: FDA announced a hearing of the Vaccines and Related Biological Products Advisory Committee. This is a virtual meeting open to the public.
December 13, 2024: FDA announced a public workshop entitled, “Patient-Focused Drug Development: Workshop to Discuss Methodologic and Other Challenges Related to Patient Experience Data.” This is a virtual meeting open to the public.
January 13, 2025: NIH announced a meeting of the National Advisory Child Health and Human Development Council. This is a virtual meeting open to the public.
January 27, 2025: NIH announced a meeting of the National Advisory Allergy and Infectious Diseases Council. This is a virtual meeting with some sessions open to the public.
January 28, 2025: NIH announced a meeting of the National Arthritis and Musculoskeletal and Skin Diseases Advisory Council. This is an in-person meeting open the public.
January 28, 2025: NIH announced a meeting of the National Advisory Council for Nursing Research. This is an in-person meeting open to the public.
April 3, 2025: NIH announced a meeting of the Board of Scientific Counselors for the National Institute of Diabetes and Digestive and Kidney Diseases. This is a hybrid meeting open to the public.
II. Hearings and Markups
- On November 19, 2024, the House Appropriations Labor, Health and Human Services, Education, and Related Agencies Subcommittee held a hearing entitled, National Institutes of Health. NIH Director Monica M. Bertagnolli was the sole witness.
- On November 19, 2024, the House Oversight and Accountability Full Committee held a hearing entitled, Oversight of the Federal Emergency Management Agency (FEMA). FEMA Administrator Deanne Criswell was the sole witness.
- On November 20, 2024, the House Appropriations Labor, Health and Human Services, Education, and Related Agencies Subcommittee held a hearing entitled, Social Security Administration (SSA). SSA Commissioner Martin O’Malley was the sole witness.
- On November 20, 2024, the House Foreign Affairs Global Health, Global Human Rights, and International Organizations Subcommittee held a hearing entitled Meeting the Challenges of Global Brain Health: Diagnosis and Treatment for the 21st Century. Witnesses included: Gladys E. Maestre, M.D., Ph.D., Director, Alzheimer’s Disease Resource Center for Minority Aging Research at the University of Texas; Benjamin C. Warf, M.D., Chairman, NeuroKids; Andy Shih, Ph.D., Chief Science Officer, Autism Speaks; and, Yashodhara Rana, Ph.D., Associate Director for Research, Eleanor Crook Foundation.
III. Reports, Studies, & Analyses
- On November 18, 2024, the Government Accountability Office (GAO) released a report entitled, Rare Disease Drugs: FDA Has Steps Underway to Strengthen Coordination of Activities Supporting Drug Development. GAO identified three actions critical to advancing rare disease drug development: (1) advancing understanding of the diseases; (2) expanding stakeholder engagement; and (3) supporting drug development efforts. GAO found that FDA had at least 18 programs addressing one of these three goals spread across its various centers. Specifically, GAO cited the recent establishment of the Rare Disease Innovation Hub as a promising step towards coordinating these various programs and enhancing cross-center collaborations, especially between the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER). GAO concluded that this initiative holds promise for guiding the agency’s rare disease activities in a strategic and coordinated fashion.
- On November 18, 2024, the HHS Office of Inspector General (OIG) released a report entitled, Medicare Improperly Paid Acute-Care Hospitals an Estimated $190 Million Over 5 Years for Outpatient Services Provided to Hospice Enrollees. OIG conducted an audit that covered $283.7 million in Part B payments to acute-care hospitals for 1.3 million outpatient services billed with condition code 07 and provided to hospice enrollees. This code indicates that a service is not related to an enrollee’s terminal illness and related conditions. For 70 out of the100 outpatient service line items sampled, payments did not comply with the requirements. Specifically, OIG found that Medicare paid acute-care hospitals for outpatient services that palliated or managed hospice enrollees’ terminal illnesses and related conditions. These services were already covered as part of the hospices’ per diem payments and should have been provided directly by the hospices or under arrangements between the hospices and acute-care hospitals. OIG estimated that Medicare could have saved $190.1 million during the audit period. In addition, OIG estimated that enrollees could have saved $43.6 million in deductibles and coinsurance that may have been incorrectly collected from them or from someone on their behalf. OIG made six recommendations to CMS, including that CMS: (1) improve system edit processes to help reduce improper payments for outpatient services provided by acute-care hospitals to hospice enrollees; (2) educate acute-care hospitals to analyze whether outpatient services palliated or managed conditions related to enrollees’ terminal illnesses; and (3) clarify Medicare guidance to specifically mention “related conditions.” CMS concurred with five of six recommendations but did not concur with the first recommendation. CMS stated that it has concerns about the feasibility and effectiveness of the type of modifications to the system edits described in the report. After reviewing CMS’s comments, OIG refined its first recommendation.
IV. Other Health Policy News
- On November 18, 2024, the Biden Administration submitted to the House of Representatives a request for an additional $98.6 billion in funding to support disaster relief efforts following Hurricane Helene and Hurricane Milton. This request includes $2.7 billion for HHS, including $260 million for HRSA to support health center infrastructure in recovery and mitigating future disasters and $536 million for the Public Health and Social Services Emergency Fund to replace medical caches, improve infrastructure, and support the Medical Reserve Corps. $252 million would also be directed at strengthening the intravenous (IV) fluid short- and long-term supply chain, following the nationwide shortages triggered by damage to a critical Baxter manufacturing plant in North Carolina. Congress is expected to approve some form of disaster aid, but exactly how much has yet to be determined. The Biden Administration’s full request can be found here.
- On November 21, 2024, Senators John Boozman (R-AR) and Peter Welch (D-VT), joined by 39 other lawmakers, sent a letter to Senate leadership urging immediate action to address the impending 2.8 percent cut to the Medicare Physician Fee Schedule (PFS), set to take effect on January 1, 2025. The letter not only advocates for preventing the payment cut but also calls for comprehensive, long-term reforms to physician payment, including changes to budget neutrality requirements and inflationary adjustments to the PFS. According to the Senators, annual cuts to the PFS jeopardize the quality of care provided to Medicare beneficiaries, particularly in underserved and rural areas, underscoring the urgent need for reform to protect patient access to high-quality, Medicare-covered services.
- On November 22, 2024, Senator Bill Cassidy (R-LA), current Ranking Member of the Senate Health, Education, Labor, and Pensions (HELP) Committee and likely Chairman of the Committee next Congress, introduced a bill to strengthen cybersecurity requirements in the health care sector, alongside fellow members of the Senate Health Care Cybersecurity Working Group, Senators Mark Warner (D-VA), John Cornyn (R-TX), and Maggie Hassan (R-NH). The Health Care Cybersecurity and Resiliency Act of 2024 directs the HHS Secretary to share information with the Director of the Cybersecurity and Infrastructure Security Agency (CISA) and collaborate in developing a resilience strategy for cyberattacks in the health care sector. The bill would update reporting requirements following a health information breach, clarify that authority for health care cybersecurity oversight lies with ASPR, and mandate that health care entities adopt minimum standards such as multifactor authentication, data encryption, and regular audits, including penetration tests. The bill also authorizes grants administered by HRSA for technology updates, workforce training, and participation in health cybersecurity threat information sharing organizations, and requires additional consideration and guidance for cybersecurity adoption in rural settings. The full bill text can be found here, and the press release for the bill’s introduction can be found here.
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