Health Care Week in Review: House Committee on Oversight and Accountability Held a Hearing on PBMs; HHS Reorganizes Technology, Cybersecurity, Data, and AI Offices

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 Oversight and Accountability held a hearing on pharmacy benefit manager (PBM) transparency and accountability, and HHS announced a reorganization of technology, cybersecurity, data, and artificial intelligence (AI) strategy and policy functions.

I. Regulations, Notices & Guidance

• On July 22, 2024, the Food and Drug Administration (FDA) released guidance entitled, Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products: Questions and Answers; Draft Guidance for Industry; Availability. This draft guidance provides answers to commonly asked questions from applicants and other interested parties regarding postapproval manufacturing changes made to biosimilar and interchangeable biosimilar products licensed under the Public Health Service Act (PHS Act).
• On July 22, 2024, FDA released a notice entitled, Food and Drug Administration Information Technology Strategy and Customer Experience Strategy; Request for Comments; Extension of Comment Period. FDA is extending the comment period for the notice announcing a request for comments that appeared in the Federal Register of June 26, 2024. In the notice, FDA requested comments on its “Information Technology (IT) Strategy” and “Customer Experience (CX) Strategy.” FDA is taking this action to allow interested persons additional time to submit comments.
• On July 22, 2024, the National Institutes of Health (NIH) released a notice entitled, Notice of Listing of Members of the National Institutes of Health’s Senior Executive Service 2024 Performance Review Board (PRB). NIH is announcing the persons who will serve on NIH’s Senior Executive Service 2024 Performance Review Board.
• On July 23, 2024, the Department of Health and Human Services (HHS) released a notice entitled, Declaration of Emergency Pursuant to the Federal Food, Drug and Cosmetic Act. The HHS Secretary is issuing this notice pursuant to the Federal Food, Drug, and Cosmetic (FD&C) Act. On July 18, 2024, the Secretary amended the April 19, 2013, determination made pursuant to the FD&C Act, regarding the avian influenza A (H79N) virus, and determined pursuant to his authority under the FD&C Act that there is a significant potential for a public health emergency (PHE) that has a significant potential to affect national security or the health and security of U.S. citizens living abroad and that involves biological agents, namely pandemic influenza A viruses and influenza A viruses with pandemic potential.
• On July 24, 2024, HHS issued a proposed rule entitled, Health Data, Technology, and Interoperability: Patient Engagement, Information Sharing, and Public Health Interoperability. This proposed rule seeks to advance interoperability, improve transparency, and support the access, exchange, and use of electronic health information through proposals for: standards adoption; adoption of certification criteria to advance public health data exchange; expanded uses of certified application programming interfaces, such as for electronic prior authorization, patient access, care management, and care coordination; and information sharing under the information blocking regulations. It proposes to establish a new baseline version of the United States Core Data for Interoperability. The proposed rule would update the ONC Health IT Certification Program to enhance interoperability and optimize certification processes to reduce burden and costs. The proposed rule would also implement certain provisions related to the Trusted Exchange Framework and Common Agreement (TEFCA), which would support the reliability, privacy, security, and trust within TEFCA.
• On July 24, 2024, the Centers for Disease Control and Prevention (CDC) released a notice entitled, Partnership Opportunity to Determine the Fit of Air Purifying Filtering Facepiece Respirators Worn Over Beard Bands for Workers with Facial Hair. The CDC National Institute for Occupational Safety and Health (NIOSH) is announcing the opportunity for respirator manufacturers, NIOSH approval holders, and beard band manufacturers to participate, through a collaborative agreement, in a project titled Fit Testing of Respirators on Those Wearing Beard Bands to determine how well respirators provide protection to workers with facial hair when using a beard band.
• On July 24, 2024, FDA released a notice entitled, Filing of Food Additive Petition from Environmental Defense Fund, Breast Cancer Prevention Partners, Center for Food Safety, Environmental Working Group, Tom Neltner, and Maricel Maffini; Request to Amend the Food Additive Regulations to Remove Authorization of Fluorinated Polyethylene; Reopening of the Comment Period; Correction. FDA is reopening the comment period for the notification of petition, published in the Federal Register of April 26, 2024, announcing that FDA has filed a food additive petition, submitted by Environmental Defense Fund, et al., proposing that the food additive regulations be amended to remove fluorinated polyethylene. FDA is reopening the comment period to add the food additive petition to the docket. FDA is also making a correction to the filing notice.
• On July 24, 2024, FDA released a notice entitled, Authorization of Emergency Use of Certain Medical Devices During COVID-19; Availability. FDA is announcing the issuance of Emergency Use Authorizations (EUAs) (the Authorizations) for certain medical devices related to COVID-19. FDA has issued the Authorizations listed in this document under the FD&C Act. These Authorizations contain, among other things, conditions on the emergency use of the authorized products. The Authorization follows the February 4, 2020, determination by the HHS Secretary, as amended on March 15, 2023, that there is a PHE, or a significant potential for a PHE, that affects, or has a significant potential to affect, national security or the health and security of U.S. citizens living abroad and that involves the virus that causes COVID-19, and the subsequent declarations on February 4, 2020, March 2, 2020, and March 24, 2020, that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of the virus that causes COVID-19, personal respiratory protective devices, and medical devices, including alternative products used as medical devices, respectively, subject to the terms of any authorization issued under the FD&C Act. These Authorizations, which include an explanation of the reasons for issuance, are listed in this document, and can be accessed on FDA’s website from the links indicated.
• On July 24, 2024, FDA released a notice entitled, Revocation of Authorization of Emergency Use of In Vitro Diagnostic Device for Detection and/or Diagnosis of COVID-19; Availability. FDA is announcing the revocation of the EUA issued to Mesa Biotech Inc., (a legal entity of Thermo Fisher Scientific), for the Accula SARS-CoV-2 Test. FDA revoked the Authorization under the FD&C Act as requested by the Authorization holder. The revocation, which includes an explanation of the reasons for revocation, is reprinted at the end of this document.
• On July 24, 2024, FDA released a notice entitled, Biosimilar Product Development Guidance; Establishment of a Public Docket; Request for Information and Comments. FDA is announcing the establishment of a docket to obtain information and comments that will assist the agency in assessing how best to advance the development of new biosimilar biological products (biosimilars or biosimilar products), as part of the Biosimilar User Fee Amendments of 2022 (BsUFA III). As FDA continues to advance the development of biosimilars, FDA is seeking input from industry on whether biosimilar product development would be best served by focusing on product class-specific guidance documents that address common development issues that apply to a broad class of products, or by developing product-specific guidance documents, similar to the approach taken in the Generic Drug User Fee Amendments (GDUFA) program.
• On July 24, 2024, FDA released a notice entitled, Evaluating the Immunogenicity Risk of Host Cell Proteins in Follow-On Recombinant Peptide Products; Establishment of a Public Docket; Request for Information and Comments. FDA is establishing a public docket to collect information and comments on evaluating and mitigating the immunogenicity risk of host cell proteins (HCPs). For the purpose of this request, FDA is specifically interested in comments on suitable methods to detect, identify, and quantify HCPs, on achievable residual amounts of HCPs for recombinant peptide products, and on the use of in vitro, in silico immunogenicity assessment (IVISIA) of HCPs in a recombinant peptide (rPeptide) product. For this request, a “follow-on” peptide product refers to the applications currently evaluated through the 505(b)(2) pathway. Although follow-on recombinant peptide products can rely on FDA’s findings of safety and effectiveness for a listed drug that is a peptide product, differences in recombinant expression systems used during the peptide production could result in quality attribute differences, including in the HCP profile, which in turn, could contribute to differences in immunogenicity risks between a follow-on recombinant peptide product and the listed drug. The public comments collected will help FDA develop recommendations on how HCP control and characterization can support comparative immunogenicity risk assessment between a recombinant follow-on peptide and the listed product.
• On July 24, 2024, FDA released guidance entitled, International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Impurities: Residual Solvents in New Veterinary Medicinal Products, Active Substances and Excipients (Revision 2); Guidance for Industry; Availability. This guidance has been developed for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). The objective of this guidance is to recommend acceptable amounts for residual solvents in pharmaceuticals for the safety of the target animal as well as for the safety of residues in products derived from treated food-producing animals. This revision updates the listings and classification of solvents.
• On July 24, 2024, FDA released guidance entitled, Providing Over-the-Counter Monograph Submissions in Electronic Format; Guidance for Industry; Availability. This guidance is intended to assist submitters by describing the electronic over-the-counter (OTC) monograph submissions requirement in the FD&C Act and providing recommendations and other information on how to send such OTC monograph submissions to FDA in electronic format. This guidance finalizes the draft guidance of the same title issued on September 28, 2022.
• On July 24, 2024, FDA released guidance entitled, Real-World Data: Assessing Electronic Health Records and Medical Claims Data To Support Regulatory Decision-Making for Drug and Biological Products; Guidance for Industry; Availability. FDA is issuing this guidance as part of its Real-World Evidence (RWE) program and to satisfy, in part, the mandate under the FD&C Act to issue guidance about the use of RWE in regulatory decision making. This guidance is intended to provide sponsors and other interested parties with considerations when proposing to use electronic health records (EHRs) or medical claims data in clinical studies to support a regulatory decision for effectiveness or safety. This guidance finalizes the draft guidance of the same title issued on September 30, 2021.
• On July 25, 2024, HHS released a notice entitled, Statement of Organization, Functions, and Delegations of Authority; Office of The National Coordinator for Health Information Technology. HHS is reorganizing the role and function of the Assistant Secretary for Administration to move technology and data policy and strategy functions from that office to the Office of National Coordinator for Health Information Technology (ONC). Under this reorganization, technology and data policy and strategy functions are moving from the Office of the Assistant Secretary for Administration (ASA) to ONC, including moving the Office of the Chief Data Officer, Office of the Chief Artificial Intelligence (AI) Officer, and a newly recreated Chief Technology Officer. ONC would be dually titled to the Assistant Secretary for Technology Policy and ONC.
• On July 26, 2024, FDA released a notice entitled, Advisory Committee; Pulmonary-Allergy Drugs Advisory Committee; Renewal. FDA is announcing the renewal of the Pulmonary-Allergy 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 Pulmonary-Allergy Drugs Advisory Committee for an additional 2 years beyond the charter expiration date. The new charter will be in effect until the May 30, 2026, expiration date.
• On July 26, 2024, NIH released a notice entitled, Request for Information (RFI) on Recommendations on Re-envisioning U.S. Postdoctoral Research Training and Career Progression within the Biomedical Research Enterprise. NIH is issuing a follow-up RFI as part of its effort to gauge feedback from the biomedical research community to inform the implementation of recommendations from the Advisory Committee to the Director Working Group on Re-envisioning NIH-Supported Postdoctoral Training.

Event Notices

August 2, 2024: FDA announced a meeting of the Genetic Metabolic Diseases Advisory Committee. This is a virtual meeting open to the public.

August 5, 2024: HHS announced a meeting of the Advisory Council on Alzheimer’s Research, Care, and Services. This is a hybrid meeting open to the public.

August 6, 2024: FDA announced a workshop entitled, Artificial Intelligence (AI) in Drug & Biological Product Development. This is a hybrid workshop open to the public.

August 7-8, 2024: CDC announced a meeting of the Advisory Board on Radiation and Worker Health. This is a virtual meeting open to the public.

August 22, 2024: The Health Resources and Services Administration (HRSA) announced a meeting of the Advisory Council on Blood Stem Cell Transplantation. This is a virtual meeting open to the public.

August 22, 2024: CDC announced a meeting of the Board of Scientific Counselors, National Institute for Occupational Safety and Health. This is a hybrid meeting open to the public.

August 26-27, 2024: The Centers for Medicare & Medicaid Services (CMS) announced a meeting of the Advisory Panel on Hospital Outpatient Payment. This is a virtual meeting open to the public.

August 27, 2024: The Substance Abuse and Mental Health Services Administration (SAMHSA) announced a meeting of the Center for Substance Abuse Prevention National Advisory Council. This is a hybrid meeting open to the public.

August 28, 2024: SAMHSA announced a joint meeting of the SAMHSA National Advisory Council (NAC), the Center for Mental Health Services NAC, the Center for Substance Abuse Prevention NAC, the Center for Substance Abuse Treatment NAC; and the two SAMHSA advisory committees: Advisory Committee for Women’s Services (ACWS) and the Tribal Technical Advisory Committee (TTAC). This is a virtual meeting open to the public.

August 28-29, 2024: HHS announced a meeting of the Presidential Advisory Council on HIV/AIDS. This is a virtual meeting open to the public.

September 10-11, 2024: CDC announced a meeting of the ICD-10 Coordination and Maintenance Committee. This is a virtual meeting open to the public.

September 18, 2024: FDA announced a meeting of the Pediatric Advisory Committee (PAC). This is a virtual meeting open to the public.

October 21-22, 2024: HHS announced a meeting of the CDC/HRSA Advisory Committee on HIV, Viral Hepatitis, and STD Prevention and Treatment. This is a hybrid meeting open to the public.

October 22-23, 2024: HRSA announced a meeting of the National Advisory Council on Migrant Health. This is a hybrid meeting open to the public.

II. Hearings & Markups

• On July 23, 2024, the House Energy and Commerce Committee, Subcommittee on Health, held a hearing entitled, Are CDC's Priorities Restoring Public Trust and Improving the Health of the American People. The witness panel included: Dr. Henry Walke, M.D., M.P.H., Director, CDC Office of Readiness and Response; Dr. Jennifer Layden, M.D., Ph.D., Director, CDC Office of Public Health Data, Surveillance, and Technology; Dr. Daniel Jernigan, M.D., M.P.H., Director, CDC National Center for Emerging and Zoonotic Infectious Diseases; Dr. Karen Hacker, M.D., M.P.H., Director, CDC National Center for Chronic Disease Prevention and Health Promotion; Dr. Demetre Daskalakis, M.D., M.P.H., Director, CDC National Center for Immunization and Respiratory Diseases; and Dr. Allison Arwady, M.D., M.P.H., Director, CDC National Center for Injury Prevention and Control.
• On July 23, 2024, the House Committee On Oversight and Accountability held a hearing entitled, The Role of Pharmacy Benefit Managers in Prescription Drug Markets Part III: Transparency and Accountability. The witness panel included: Adam Kautzner, PharmD, President, Evernorth Care Management & Express Scripts; David Joyner, Executive Vice President, CVS Health; President, CVS Caremark; and Patrick Conway, MD, Chief Executive Officer, OptumRx.
• On July 23, 2024, the House Committee on Administration held a hearing entitled, Congress in a Post-Chevron World. The witness panel included: Mr. Wayne Crews, Fellow in Regulatory Studies, Competitive Enterprise Institute; Dr. Kevin Kosar, Resident Senior Fellow, American Enterprise Institute; The Honorable Paul Ray, Director, The Thomas A. Roe Institute for Economic Policy Studies at the Heritage Foundation; Mr. Satya Thallman, Senior Vice President of Government Affairs, Americans for Responsible Innovation; and, Dr. Josh Chafetz, Agnes Williams Sesquicentennial Professor of Law and Politics, Georgetown University Law Center.

III. Reports, Studies, & Analyses

• On July 23, 2024, the Kaiser Family Foundation (KFF) released a report entitled, Medicare Advantage Enrollees Account for a Rising Share of Inpatient Hospital Days. The report finds that nearly half of inpatient days in 2022 were attributable to Medicare Advantage (MA) enrollees. Additionally, more than half of all eligible Medicare beneficiaries now receive their Medicare coverage through private MA plans and the data shows that three in 10 hospitals “had more inpatient days from Medicare Advantage enrollees than traditional Medicare enrollees in 2022,” and the fastest growth in MA inpatient days was in hospitals in non-metropolitan counties where the increase more than doubled in 2022.
• On July 25, 2024, the U.S. Government Accountability Office (GAO) released a report entitled, Public Health Preparedness: HHS Should Assess Jurisdictional Planning for Isolation and Quarantine. GAO found that while seven selected jurisdictions used isolation and quarantine during the COVID-19 pandemic, they faced challenges such as enforcement difficulties and facility logistics. Although some jurisdictions had detailed plans prior to the pandemic, others had only high-level provisions. In response to COVID-19, jurisdictions have updated their plans to better identify isolation and quarantine facilities. The CDC provided guidance and funding but did not give advance notice of guidance changes, which delayed implementation. The CDC has a new process for advance notice but has not documented it. Additionally, the CDC has not assessed jurisdictions' planning efforts, missing critical information needed to identify and address preparedness gaps. In the report, GAO recommended that the CDC document its process for sharing finalized guidance with jurisdictions before publication and assess jurisdictions' planning for isolation and quarantine. HHS agreed with these recommendations.

IV. Other Health Policy News

• On July 23, 2024, Senate Health, Education, Labor, and Pensions (HELP) Committee Ranking Member Bill Cassidy (R-LA) introduced the Upholding Standards of Accountability (USA) Act to address concerns about executive overreach following the Supreme Court’s recent overturning of Chevron deference. This landmark decision overturned the judicial precedence of deferring to federal agencies’ interpretations of ambiguous statutes, which Senator Cassidy argued has led to excessive executive power and reduced congressional oversight. The USA Act aims to enhance accountability by mandating that agency heads testify before the relevant committees of jurisdiction on major rules, requiring Senate-confirmed nominees to appear before the Senate committee with jurisdiction over such nomination, improving cost-benefit analyses through retrospective reviews, and ensuring timely and substantive responses to congressional oversight. This bill is part of Ranking Member Cassidy's response to the Supreme Court’s decision and efforts to ensure federal agencies adhere strictly to congressional intent. The bill text is available here.
• On July 24, 2024, Senator Edward Markey (D-MA) and Representative Pramila Jayapal (D-WA) introduced the Health Over Wealth Act to address concerns over private equity’s impact on health care. According to a press release from Senator Markey’s office, the legislation aims to enhance transparency and accountability for private equity firms and for-profit entities owning health care facilities. Key provisions include requiring detailed financial reporting, setting up escrow accounts to cover expenses in case of facility closures, and banning practices that undermine quality, safety, or access to care. The bill also seeks to address certain tax provisions and establish a task force to review private equity’s role in health care. The introduction parallels the Senate HELP Committee vote to investigate the Steward Health Care bankruptcy and subpoena Steward Health Care’s Chief Executive Office (CEO). The bill text is available here.
• On July 24, 2024, HHS awarded $45.1 million through SAMHSA to bolster mental health and substance use services across the lifespan. This funding includes $15.3 million specifically for children and youth, aimed at supporting mental health in schools, addressing trauma, and assisting transitional-age youth with serious conditions. The grants will support a range of initiatives, including services for the homeless, school-based mental health programs, and trauma-focused treatment for children. Additional funds will enhance supported employment, minority substance use treatment, and opioid recovery programs. A press release with more information is available here.
• On July 25, 2024, HHS announced a reorganization aimed at enhancing its technology, cybersecurity, data, and AI strategy and policy functions. This move will consolidate responsibilities previously spread across various offices to create a more streamlined structure to better address the growing opportunities in data and technology in healthcare. The reorganization will see ONC renamed as the Assistant Secretary for Technology Policy and Office of the National Coordinator for Health Information Technology (ASTP/ONC). This office will now oversee technology, data, and AI policy and strategy, including the roles of Chief Technology Officer, Chief Data Officer, and Chief AI Officer. Additionally, the health sector cybersecurity program (“405(d) Program”) will move to the Administration for Strategic Preparedness and Response (ASPR), aligning all healthcare cybersecurity activities under one umbrella. This restructuring aims to ensure HHS remains agile, accountable, and strategic in addressing the pressing issues in healthcare technology. A press release with more information is available here.

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