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, CMS released guidance on the Medicare Prescription Payment Plan, which allows Medicare beneficiaries to pay prescription costs in monthly instalments, and the House held a legislative hearing on 19 bipartisan health care legislations.
I. Regulations, Notices & Guidance
- On February 12, 2024, the Food and Drug Administration (FDA) released a notice entitled, Use of Data Monitoring Committees in Clinical Trials; Draft Guidance for Industry; Availability; Agency Information Collection Activities; Proposed Collection; Comment Request. FDA is announcing the availability of a draft guidance for industry entitled, Use of Data Monitoring Committees in Clinical Trials. This guidance is intended to assist sponsors of clinical trials in determining when a data monitoring committee (DMC) (also known as a data and safety monitoring board (DSMB), a data and safety monitoring committee (DSMC), or an independent data monitoring committee (IDMC)) would be useful for trial monitoring and what procedures and practices should be considered to guide their operation. When finalized, this guidance will supersede the final guidance for clinical trial sponsors entitled Establishment and Operation of Clinical Trial Data Monitoring Committees, issued in March 2006. This draft guidance is not final nor is it in effect at this time.
- On February 13, 2024, the Administration for Community Living (ACL) released a notice entitled, Availability of Program Application Instructions for Adult Protective Services Funding. ACL is establishing the Elder Justice Act – Adult Protective Services funding opportunity in accordance with section 2042(b) of subtitle B of title XX of the Social Security Act, otherwise known as the Elder Justice Act (EJA) as authorized and funded through the Further Additional Continuing Appropriations and Other Extensions Act, 2024.
- On February 13, 2024, FDA released a notice entitled, Training Program for Regulatory Project Managers; Information Available to Industry. FDA’s Center for Drug Evaluation and Research (CDER) is announcing the continuation of the Regulatory Project Management Site Tours and Regulatory Interaction Program (the Site Tours Program). The purpose of this document is to invite pharmaceutical companies interested in participating in this program to contact CDER.
- On February 14, 2024, FDA released a notice entitled, Charging for Investigational Drugs Under an Investigational New Drug Application: Questions and Answers; Guidance for Industry; Availability. FDA is announcing the availability of a final guidance for industry entitled Charging for Investigational Drugs Under an IND: Questions and Answers. This guidance addresses frequently asked questions related to the implementation of FDA’s regulation on charging for investigational drugs under an investigational new drug application (IND) for the purpose of either clinical trials or expanded access for treatment use. This guidance finalizes the revised draft guidance of the same title issued on August 23, 2022, and replaces the final guidance issued on June 3, 2016.
- On February 15, 2024, FDA released a notice entitled, Guidance: Master Protocols for Drug and Biological Product Development. FDA is extending the comment period for the notice of availability that published in the Federal Register of December 22, 2023. In that notice, FDA requested comments on the draft guidance for industry entitled, Master Protocols for Drug and Biological Product Development. FDA is taking this action in response to requests for an extension to allow interested persons additional time to submit comments.
- On February 15, 2024, FDA released a notice entitled, Guidance: Product-Specific Guidances. FDA is announcing the availability of additional draft and revised draft product-specific guidances. The guidances provide 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 guidances identified in this notice were developed using the process described in that guidance.
- On February 16, 2024, the Agency for Healthcare Research and Quality (AHRQ) released a notice entitled, National Advisory Council for Healthcare Research and Quality: Request for Nominations for Members. The National Advisory Council for Healthcare Research and Quality (the Council) advises the Secretary of the Department of Health and Human Services (HHS) and the Director of AHRQ with respect to activities proposed or undertaken to carry out AHRQ’s statutory mission. AHRQ produces evidence to make health care safer, higher quality, more accessible, equitable, and affordable, and works within HHS and with other partners to make sure that the evidence is understood and used. Seven new members will be appointed to replace seven current members whose terms will expire in November 2024.
Event Notices
February 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.
February 22-23, 2024: HHS announced a meeting of the National Vaccine Advisory Committee (NVAC). This is a hybrid meeting open to the public.
February 27, 2024: The Substance Abuse and Mental Health Services Administration (SAMHSA) announced a meeting of SAMHSA’s Tribal Technical Advisory Committee (TTAC). This is a hybrid meeting open to the public.
February 27, 2024: SAMHSA announced a meeting of SAMSHA’s Center for Mental Health Services National Advisory Council. This is a hybrid meeting open to the public.
February 28-29, 2024: The Centers for Disease Control and Prevention (CDC) announced a meeting of the Advisory Committee on Immunization Practices. This is a virtual meeting open to the public.
March 5, 2024: HHS announced a meeting of the Vaccines and Related Biological Products Advisory Committee. This is a virtual meeting open to the public.
March 6, 2024: CDC announced a meeting of the Board of Scientific Counselors, National Center for Health Statistics. This meeting is open to the public.
March 7, 2024: AHRQ announced a meeting for Software Developers on the Common Formats for Patient Safety Data Collection. This is a virtual meeting open to the public.
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: 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 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.
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: SAMHSA announced a meeting of the Interdepartmental Serious Mental Illness Coordinating Committee.
II. Hearings & Markups
House of Representatives
- On February 14, 2023, the House Energy and Commerce Subcommittee on Health held a hearing entitled, Legislative Proposals to Support Patients and Caregivers. Witnessed included: Dr. Andy Shih, PhD, Chief Science Officer, Autism Speaks; Mr. Corey Feist, JD, MBA, Co-Founder and CEO, Dr. Lorna Breen Heroes' Foundation; Dr. Joanne Pike, DrPH, President and CEO, Alzheimer’s Association Dr. Gordon Tomaselli, MD, Former President, American Heart Association; Marilyn and Stanley M. Katz Dean, Emiritus and Professor of Medicine, Albert Einstein College of Medicine; Adjunct Professor of Medicine, Johns Hopkins University School of Medicine; Ms. Michelle Whitten, President, CEO, and Co-Founder, Global Down Syndrome Foundation; Mr. Randy Strozyk, President, American Ambulance Association; and Dr. Christina Annunziata, MD, PhD, Senior Vice President of Extramural Discovery Science, American Cancer Society.
- On February 14, 2024, the House Committee on the Budget held a hearing entitled, The Congressional Budget Office's Budget and Economic Outlook. The witnesses present was: Dr. Phillip Swagel, Director, Congressional Budget Office (CBO).
- On February 15, 2024, the House Committee on Oversight and Accountability Select Committee on the Coronavirus Pandemic held a hearing entitled, Assessing America’s Vaccine Safety Systems, Part 1. Witnesses included: Dr. Daniel Jernigan, M.D., M.P.H., Director, National Center for Emerging Zoonotic Infectious Diseases, CDC; Dr. Peter Marks, M.D., Ph.D., Director, Center for Biologics Evaluation and Research (CBER); and CDR George Reed Grimes, M.D., M.P.H., Director, Division of Injury Compensation Programs, HRSA.
III. Reports, Studies, & Analyses
- On February 15, 2024, the Government Accountability Office (GAO) released a report entitled, VA Health Care: Opportunities Exist to Further Meet Student Veterans' Mental Health Needs. The Department of Veterans Affairs (VA) provides mental health care to veterans, with data showing that student veterans receive such care at higher rates than the overall veteran population. To address this issue, the VA administers the Veterans Integration to Academic Leadership program to support student veterans’ mental health needs through partnerships with colleges. GAO found that as of October 2023, only a quarter of VA health care systems offer this program. Additionally, the report found that the VA lacks a systematic approach to inform its systems about program implementation. GAO recommends that VA regularly communicate comprehensive information about the program to all its health care systems to ensure they have the necessary guidance for participation. VA has concurred with this recommendation.
- On February 14, 2024, the Office of Inspector General (OIG) released a report entitled, Medicare Generally Paid for Evaluation and Management Services Provided via Telehealth During the First 9 Months of the COVID-19 Public Health Emergency That Met Medicare Requirements. OIG audited over 19 million Evaluation and Management (E/M) service claims, totaling roughly $1.4 billion in Medicare Part B payments, to assess if providers billing for 110 different telehealth E/M services complied with Medicare requirements from March 2020 to November 2020. The report found that during this nine month period, providers complied with Medicare requirements for 105 of the 110 E/M telehealth services that OIG sampled. OIG assessed compliance due to the rapid expansion of telehealth services in Medicare during the COVID-19 pandemic; however, OIG did not produce recommendations since most providers were found to be compliant.
- On February 12, 2024, the RAND Corporation released a journal article entitled, Changes in Hospice Care Experiences During the COVID-19 Pandemic. The demand for hospice and palliative care services surged during the COVID-19 pandemic, despite challenges like staffing shortages and visitation restrictions in institutional settings. In this report, researchers analyzed national data from the Consumer Assessment of Healthcare Providers and Systems (CAHPS) Hospice Survey to understand how the pandemic may have affected patient characteristics, care settings, and experiences. According to the report, while patient characteristics remained consistent, there was a notable shift towards receiving care at home, away from other settings like nursing homes. Caregivers reported decreased involvement in care across all settings except home. Data showed that the pandemic had small negative effects on reported hospice care quality, with variations across settings. The shift to home care may have mitigated some pandemic-related challenges, but there were still concerns about care experiences in institutional settings due to physical separation from family members.
- On February 15, 2024, Alston & Bird issued a health care advisory entitled, HHS Final Rule Brings Sweeping, Complex Changes for Substance Use Records. On February 8, 2024, HHS issued a 485-page final rule, updating federal regulations governing substance use disorder (SUD) patient records at 42 CFR Part 2. These revisions align certain provisions with Health Insurance Portability and Accountability Act (HIPAA) while maintaining patient confidentiality. The final rule becomes effective 60 days post-publication, with a compliance deadline set at 24 months thereafter. Patients can now file complaints with HHS regarding Part 2 violations, similar to the HIPAA process, without facing adverse actions from Part 2 programs.
- Noncompliance with Part 2 regulations will be subject to HIPAA enforcement mechanisms and penalties. Definitions have been updated, and consent provisions now align with HIPAA’s authorization requirements. Various provisions regarding disclosures, redisclosures, breach notifications, and patient rights have been clarified and updated. HHS acknowledges the complexities of compliance with both Part 2 and HIPAA regulations and offers support and resources for implementation. Moving forward, affected entities should begin preparations for compliance, including updating privacy notices, establishing a patient complaint process, and revising policies, procedures, and consent forms. Companies operating across multiple states should assess their obligations under both federal and state regulations.
IV. Other Health Policy News
- On February 14, 2024, the Federal Trade Commission (FTC) and HHS jointly issued a Request for Information (RFI) to delve into the roles of group purchasing organizations (GPOs) and drug wholesalers in contributing to generic drug shortages. The agencies are specifically interested in understanding market concentration, compliance with legal obligations, and the impacts on smaller health care providers and rural hospitals. Additionally, they seek insights into how the compensation model of GPOs, which involves rebates and administrative fees from manufacturers, affects generic drug markets. This initiative aims to shed light on alleged opaque practices and potential solutions to ensure adequate access to affordable generic drugs. The public will have 60 days to submit comments at Regulations.gov. Once submitted, comments will be posted to Regulations.gov. A press release with more information is available here.
- On February 14, 2024, Senate Health, Education, Labor, and Pensions (HELP) Committee Chairman Bernie Sanders (I-VT) and Senator Mike Braun (R-ID) introduced S. 3548, the Health Care PRICE Transparency Act 2.0. The bill would establish regulations for insurers to reveal all negotiated rates; increase penalties for hospitals failing to disclose their pricing; broaden transparency mandates to include laboratories, imaging facilities, and outpatient surgery centers; and ensure employers have access to their claims information. This Senate bill goes farther than H.R.5378, the Lower Costs, More Transparency Act that was recently passed in the House by requiring hospitals and insurance companies to make public all actual prices—rather than just estimates—along with billing codes.
- On February 15, 2024, the Centers for Medicare & Medicaid Services (CMS) announced it had issued additional guidance on the Medicare Prescription Payment Plan, a program introduced under the Inflation Reduction Act (IRA), allowing Medicare beneficiaries to pay out-of-pocket prescription drug costs in monthly installments starting in 2025. The draft guidance outlines requirements for Medicare Part D plan sponsors, including education and outreach efforts, pharmacy processes, and operational considerations. This initiative aims to alleviate the burden of high upfront drug costs for seniors and individuals with disabilities by offering more manageable payment options. CMS has encouraged stakeholders to review the guidance and provide feedback to ensure effective implementation of the program. The Medicare Prescription Payment Plan is part of broader efforts to reduce prescription drug and healthcare costs for Medicare beneficiaries, complementing existing provisions such as expanded eligibility for the Low-Income Subsidy program and caps on out-of-pocket costs. A press release with more information is available here.
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