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 the SUPPORT for Patients and Communities Reauthorization Act and the Lower Cost, More Transparency Act, and the Department of Health and Human Services (HHS) issued a final rule to advance health IT interoperability and algorithm transparency. Read more about these actions and other news below.

I. Regulations, Notices & Guidance

• On December 11, 2023, the Agency for Healthcare Research and Quality (AHRQ) issued a notice entitled, Supplemental Evidence and Data Request on Systematic Review – Interventions to Improve Care of Bereaved Persons. AHRQ is seeking scientific information submissions from the public. Scientific information is being solicited to inform our review on Systematic Review - Interventions to Improve Care of Bereaved Persons, which is currently being conducted by the AHRQ’s Evidence-based Practice Centers (EPC) Program. Access to published and unpublished pertinent scientific information will improve the quality of this review.
• On December 12, 2023, the Food and Drug Administration (FDA) issued a notice entitled, Advisory Committee; Genetic Metabolic Diseases Advisory Committee; Establishment. Under the Federal Advisory Committee Act, FDA is announcing the establishment of the Genetic Metabolic Diseases Advisory Committee. The Commissioner of Food and Drugs (Commissioner) has determined that it is in the public interest to establish such a committee. Duration of this committee is two years from the date the Charter is filed, unless the Commissioner formally determines that renewal is in the public interest.
• On December 12, 2023, FDA issued a notice entitled, Data Standards; Support and Requirement Begins for the Clinical Data Interchange Standards Consortium Version 2.0 of the Study Data Tabulation Model, Version 3.4 of the Study Data Tabulation Model Implementation Guide, and Version 1.0 of the Standard for Exchange of Nonclinical Data Implementation Guide--Genetox; Requirement Ends for the Clinical Data Interchange Standards Version 3.2 of the Study Data Tabulation Model Implementation Guide. FDA, the Center for Biologics Evaluation and Research (CBER) and Center for Drug Evaluation and Research (CDER) are announcing that support begins for version 2.0 of the Clinical Data Interchange Standards Consortium (CDISC) Study Data Tabulation Model (SDTMv2.0), version 3.4 of the CDISC Study Data Tabulation Model Implementation Guide (SDTMIGv3.4), and version 1.0 of the Standard for Exchange of Nonclinical Data Implementation Guide--Genetox (SENDIGGenetoxv1.0) and announcing the date that these version updates are required in certain submissions. CBER and CDER are also announcing the date that requirement ends for version 3.2 of the CDISC SDTMIG (SDTMIGv3.2). The FDA will update the FDA Data Standards Catalog (Catalog) to reflect these changes. The FDA will also publish in the technical specifications document entitled “Study Data Technical Conformance Guide” additional details on how to implement new variables.
• On December 12, 2023, FDA issued draft guidance entitled, Advanced Manufacturing Technologies Designation Program; Draft Guidance for Industry; Availability; Agency Information Collection Activities; Proposed Collection; Comment Request. FDA encourages the early adoption of advanced manufacturing technologies (AMTs) that have the potential to benefit patients by improving manufacturing and supply dependability and optimizing development time of drug and biological products. These technologies can be integral to ensuring quality and supporting a robust supply of drugs that are life-supporting, life-sustaining, of critical importance to providing healthcare, or in shortage. AMTs can directly improve product quality through higher capability manufacturing designs and enhanced controls (e.g., leading to fewer human errors). This draft guidance provides recommendations to persons and organizations interested in participating in FDA’s Advanced Manufacturing Technologies Designation Program, which is intended to facilitate the development of drugs, including biological products, manufactured using an AMT that has been designated as such under the program.
• On December 12, 2023, FDA issued a notice entitled, Methodological Challenges Related to Patient Experience Data; Summary of Received Comments. FDA is announcing the availability of a summary on the comments received for the “Methodological Challenges Related to Patient Experience Data; Request for Information and Comments” notice published on May 2, 2023. The input received in response to the Request for Information (RFI) will help FDA plan two public workshops focused on methodological challenges and will help FDA identify priorities for future work.
• On December 13, 2023, the Centers for Medicare & Medicaid Services (CMS) issued a notice entitled, Medicare Program; Application by The Joint Commission (TJC) for Continued CMS Approval of its Home Infusion Therapy (HIT) Accreditation Program. This final notice announces CMS’ decision to approve The Joint Commission (TJC) 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 December 13, 2023, the Health Resources and Services Administration (HRSA) issued a notice entitled, National Vaccine Injury Compensation Program; List of Petitions Received. HRSA is publishing this notice of petitions received under the National Vaccine Injury Compensation Program (the Program), as required by the Public Health Service (PHS) Act, as amended. While the Secretary of the Department of Health and Human Serviced (HHS) is named as the respondent in all proceedings brought by the filing of petitions for compensation under the Program, the United States Court of Federal Claims is charged by statute with responsibility for considering and acting upon the petitions.
• On December 14, 2023, CMS issued a notice entitled, Inflation Reduction Act (IRA) Revised Program Guidance. CMS is announcing the availability of CMS’ revised guidance for the Medicare Part B and Part D Prescription Drug Inflation Rebate Program for the implementation of the Inflation Reduction Act (IRA). CMS will release additional IRA-related guidance; all can be viewed on the dedicated IRA section of the CMS website.
• On December 15, 2023, the Indian Health Services (IHS) issued a notice entitled, Funding Opportunity for the Community Opioid Intervention Prevention Program. The purpose of this grant program is to address the opioid crisis in American Indian/Alaska Native communities by doing the following: (1) developing and expanding community education and awareness of prevention, treatment, and recovery activities for opioid misuse and opioid use disorder (OUD); (2) increasing knowledge and use of culturally appropriate interventions and to encourage an increased use of medication-assisted treatment/medications for OUD (MAT/MOUD); (3) supporting Tribal and Urban Indian communities in their effort to provide prevention, treatment, and recovery services to address the impact of the opioid crisis; and (4) increase harm reduction within their communities.

Event Notices

• December 20, 2023: HHS announced a meeting of the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria. This is a virtual meeting open to the public.
• January 19, 2024: HHS announced a meeting of the 2023 Dietary Guidelines Advisory Committee. This is a virtual meeting open to the public.
• January 24, 2024: The National Institutes of Health (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 25, 2024: HRSA announced a meeting of the Advisory Committee on Interdisciplinary, Community-Based Linkages (ACICBL). 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 will hold a meeting that is open to the public.
• February 14, 2024: The Centers for Disease Control and Prevention (CDC) announced a meeting of the Advisory Board on Radiation and Worker Health, National Institute for Occupational Safety and Health. This meeting is open to the public, but without a public comment period. The public can join the meeting by teleconference.
• February 27, 2024: The Substance Abuse and Mental Health Services Administration (SAMHSA) announced a meeting of SAMHSA’s Tribal Technical Advisory Committee (TTAC). The meeting is open to the public and will be held in person.

II. Hearings & Markups

U.S. House of Representatives

• On December 13, 2023, the House Committee on Energy and Commerce held a hearing entitled, Leveraging Agency Expertise to Foster American AI Leadership and Innovation. Witnesses present included Director Helena Fu, Director of Critical and Emerging Technology, Office of the Undersecretary for Science, Department of Energy; Dr. Micky Tripathi, National Coordinator for Health Information Tech, HHS; and Mr. Saif Khan, Senior Advisor to Secretary for Critical and Emerging Technologies, Department of Commerce.
• On December 13, 2023, the House Committee on Oversight and Accountability held a hearing entitled, Reforming the WHO: Ensuring Global Health Security and Accountability. Witnesses present included Loyce Pace, M.P.H, Assistant Secretary for Global Affairs, HHS; John Nkengasong, M. Sc., Ph.D., Ambassador-at-Large, U.S. Global AIDS Coordinator, Senior Bureau Official for Global Health Security and Diplomacy, U.S. Department of State; and Atul Gawande, M.D., M.P.H., Assistant Administrator for Global Health, United States Agency for International Development.
• On December 13, 2023, the House Committee on Ways and Means Oversight Subcommittee held a hearing entitled, Growth of the Tax-Exempt Sector and the Impact on the American Political Landscape.

U.S. Senate

• On December 12, 2023, the Senate Committee on Health, Education, Labor, and Pensions (HELP) held a markup on S. 1840, the SCREENS for Cancer Act of 2023, S. 3392, the Advancing Research in Education Act, S. 3393, the SUPPORT for Patients and Communities Reauthorization Act, and S. 644, the Modernizing Opioid Treatment Access Act. All four bills under consideration were ordered reported favorably, as amended, to the full Senate.
• On December 14, the Senate HELP Committee held a hearing entitled, What is Fueling the Diabetes Epidemic?. Witnesses present included Ashley Gearhardt, Ph.D., Professor of Psychology, University of Michigan; Lindsey Smith Taillie, Ph.D., Associate Professor, Department of Nutrition, University of North Carolina; Kasia Lipska, M.D., M.H.S, Associate Professor of Medicine, Yale School of Medicine, Natalie Stanback, Volunteer, Juvenile Diabetes Research Foundation (JDRF); and Aaron J. Kowalski, Ph.D., Chief Executive Officer, JDRF.

III. Reports, Studies, & Analyses

• On December 12, 2023, the Government Accountability Office (GAO) released a report entitled, Private Health Insurance: Roll out of Independent Dispute Resolution Process for Out-Of-Network Claims Has Been Challenging. The report finds that of the roughly 490,000 disputes filed from April 2022 to June 2023, about 61 percent were still unresolved as of June 2023. GAO identified that the primary causes for these delays include the complexity of determining if disputes are eligible for the independent dispute resolution (IDR) process, the higher-than-expected volume of the disputes filed, and budget constraints. GAO interviewed multiple providers and insurers as part of the report, finding that the backlog of disputes has resulted in delays of provider payments. While CMS and the Department of Labor (DOL) continue to look into complaints received, stakeholders expressed frustrations that their complaints are often not responded to.
• On December 12, 2023, the Congressional Budget Office (CBO) released a report entitled, Estimated Direct Spending and Revenue Effects of H.R. 5378, the Lower Costs, More Transparency Act. On September 14, 2023, CBO published an estimate for the Lower Costs, More Transparency Act, H.R. 5378. CBO estimated that enacting that version of the bill would reduce the federal deficit by $833 million over the 2024-2033 period. Subsequent changes to the language reduced estimated direct spending by $172 million, on net, and reduced estimated revenues by $290 million over the 10-year period. Changes to sections 106, 111, 304, and 404 increased direct spending by $1,267 million and reduced revenues by $290 million; changes to sections 301 and 302 reduced direct spending by $1,439 million.
• On December 14, 2023, the Office of the Inspector General (OIG) released a report entitled, The Consistently Low Percentage of Medicare Enrollees Receiving Medication to Treat Their Opioid Use Disorder Remains a Concern. The report highlighted concerns about low access to OUD treatment among Medicare enrollees, with only 18 percent receiving medication for their disorder. The report stated that certain groups faced more significant challenges in obtaining medication than others. According to the report, although over 600,000 Medicare enrollees received naloxone, a concern arose in its shift from prescription to over-the-counter status. This change potentially affects Medicare coverage of the drug and as stated in the report, could raise costs and limit access. OIG recommended CMS continue to enhance access to treatment for OUDs for Medicare beneficiaries. Additionally, OIG recommended continuing efforts to educate providers on the use of buprenorphine to treat OUD and informing enrollees about alternative access to naloxone as it transitions out of Part D coverage.

IV. Other Health Policy News

• On December 11, 2023, the House of Representatives voted in support of the Lower Costs, More Transparency Act, H.R. 5378.  This legislation was introduced by leadership of the House Energy and Commerce Committee, the Ways and Means Committee, and the House Education and Workforce Committee. The bill, approved by a vote of 320-71, would extend funding for several primary care and healthcare workforce programs including: (1) a 10 percent increase in mandatory funding for Community Health Centers (CHCs); (2) $350 million yearly funding for the National Health Service Corps (NHSC) for fiscal years (FYs) 2024 and 2025; and (3) a seven-year reauthorization for the Teaching Health Center Graduate Medical Education (THCGME) program and $300 million in funding for the program for FYs 2028, 2029, and 2030. Additionally, the bill would codify current hospital price transparency rules, increase the penalties for price transparency rule noncompliance, reform pharmacy benefit manager (PBM) practices, require site neutral Medicare reimbursement policies for hospital outpatient off-campus department physician administered drugs, and impose a national patient identifier number on hospital outpatient departments. The bill would also eliminate two years of the scheduled Medicaid Disproportionate Share Hospital (DSH) payment cuts. Prospects for Senate consideration of the bill currently are unclear as Senate committees of jurisdiction are developing their own versions of similar policies. The full text of the bill is available here.
• On December 12, 2023, the House of Representatives voted to advance, the SUPPORT for Patients and Communities Reauthorization Act, H.R. 4531. The bill reauthorizes expiring programs that were originally included in the Substance Use-Disorder That Promotes Opioid Use Recovery and Treatment for Patients and Communities (SUPPORT) Act. H.R. 4531 addresses funding for community-based mental health and substance use-disorder (SUD) treatment and recovery programs, eliminates the Institution of Medical Diseases exclusion, and requires state Medicaid programs to cover all three FDA-approved medications for OUD - buprenorphine, methadone, and naltrexone. The Senate HELP Committee also voted in support of S. 3393, its version of legislation reauthorizing the SUPPORT Act, in a committee markup on December 12, 2023, by a vote of 19-1.The text of the House bill is available here. The text of the Senate bill is available here.
• On December 12, 2023, HHS released the National Plan to Address Alzheimer’s Disease 2023 Update, showcasing progress made in the fight against Alzheimer’s and related dementias (ADRD). In 2023, FDA approved a drug to slow AD progression, CMS launched initiatives like the GUIDE Model to improve care and support for those with dementia and caregivers. The update outlines various actions taken throughout 2023, including a CDC-led summit on dementia risk reduction. The National Plan aims to achieve six critical goals by 2025, recognizing the increasing impact of dementia on public health due to the aging population. A press release with more information is available here.
• On December 12, 2023, HHS issued guidance to help states establish worker registries to connect Medicaid recipients with qualified healthcare workers and home and community-based services (HCBS). Emphasizing President Biden’s American Rescue Plan funding of $37 billion dollars, this initiative aims to address care shortages, improve quality, and allow people to remain in their communities. CMS released data supporting these efforts, aligning with broader goals to enhance Medicaid and support caregivers. A press release with more information is available here.
• On December 13, 2023, HHS Office of the National Coordinator (ONC) released its health information technology (HTI-1) final rule regarding how to make transparent the information on use of algorithms in health care clinical decision making. The final rule clarifies that health information technology (IT) developers are only responsible for the predictive algorithms they supply and establishes baseline requirement which health IT developers must make transparent about their algorithms.  According to HHS’ press release, the “HTI-1 final rule advances patient access, interoperability, and standards”, including the following:
• • Algorithm Transparency: the final rule establishes transparency requirements for the artificial intelligence (AI) and other predictive algorithms that are part of certified health IT. HHS’ approach will promote responsible AI and make it possible for clinical users to access a consistent, baseline set of information about the algorithms they use to support their decision making and to assess such algorithms for fairness, appropriateness, validity, effectiveness, and safety.
  • USCDI Version 3: the final rule adopts the United States Core Data for Interoperability (USCDI) Version 3 (v3) as the new baseline standard within the ONC Health IT Certification Program as of January 1, 2026. USCDI v3 includes updates to prior USCDI versions focused on advancing more accurate and complete patient characteristics data that could help promote equity, reduce disparities, and support public health data interoperability.
  • Enhanced Information Blocking Requirements: the final rule revises certain information blocking definitions and exceptions to support information sharing, and adds a new exception to encourage secure, efficient, standards-based exchange of electronic health information under the Trusted Exchange Framework and Common Agreement^SM (TEFCA^SM).
  • New Interoperability-Focused Reporting Metrics for Certified Health IT: the final rule implements the 21^st Century Cures Act’s requirement to adopt a Condition of Certification for developers of certified health IT to report certain metrics to give more insight into how certified health IT is used in support of care delivery.
• The final rule is available here. A press release with more information is available here.
• On December 14, 2023, Representatives Mariannette Miller-Meeks, M.D. (R-IA-01), Ami Bera, M.D. (D-CA-06), Larry Bucshon, M.D. (R-IN-08), and Kim Schrier, M.D. (D-WA-08) penned a letter to House and Senate leadership urging congressional action to prevent the impending 3.37 percent cut in Medicare reimbursement to physicians starting on January 1, 2024. The letter was signed by 193 Members of the House of Representatives. In the letter, Representatives highlight the critical necessity of congressional intervention to preserve Medicare patients’ access to high-quality health care. They underscore the challenges faced by healthcare providers in coping with inflationary pressures and workforce shortages. The cuts, if enacted, could lead to reduced access to care, particularly impacting seniors and those in underserved areas. Various medical organizations echoed these concerns, warning of service cuts, staff reductions, and decreased investments in healthcare programs. The Representatives emphasized the unsustainable nature of cuts to physician reimbursement and stressed the importance of congressional action to support healthcare providers serving Medicare patients. A press release with the letter is available here.

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