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 issued a final rule outlining the fees for the Federal Independent Dispute Resolution process under the No Surprises Act and Ways and Means Democrats released additional reports detailing the U.S. health care system’s role in the climate crisis.
I. Regulations, Notices & Guidance
On December 18, 2023, the Food and Drug Administration (FDA) issued guidance entitled, Guidance: Use of Real-World Evidence To Support Regulatory Decision-Making for Medical Devices. FDA is issuing this draft guidance to clarify how FDA evaluates real-world data (RWD) to determine whether they are of sufficient quality for generating real-world evidence (RWE) that can be used in FDA regulatory decision-making for medical devices. This draft guidance proposes expanded recommendations to the 2017 guidance entitled Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices. This draft guidance is not final nor is it for implementation at this time.
On December 18, 2023, FDA issued guidance entitled, Guidance: Registration and Listing of Cosmetic Product Facilities and Products. The final guidance will assist persons submitting cosmetic product facility registrations and product listing submissions to FDA under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). This guidance also includes a new draft section, Appendix B, for comment purposes only, that describes frequently asked questions and answers about cosmetic product facility registrations and product listing submissions. Aside from that section, this guidance finalizes the draft guidance that was published on August 8, 2023.
On December 18, 2023, the Department of Health and Human Services (HHS), Labor, and Treasury (Departments) issued a final rule entitled, Federal Independent Dispute Resolution Process Administrative Fee and Certified Independent Dispute Resolution Entity Fee Ranges. This final rule finalizes proposals related to the fees established by the No Surprises Act (NSA) for the Federal I Dispute Resolution (IDR) process, as established by the Consolidated Appropriations Act, 2021 (CAA, 2021). These final rules amend existing regulations to provide that the administrative fee amount charged by the Departments to participate in the Federal IDR process, and the ranges for certified IDR entity fees for single and batched determinations, will be set by the Departments through notice and comment rulemaking.
On December 19, 2023, FDA issued a notice entitled, Notice to Public of Website Location of the Office of the Chief Scientist Proposed Guidance Development List. FDA is announcing the website location where the agency will post a list of possible topics for future guidance document development or revision by the Office of the Chief Scientist (OCS) during the next year. In addition, FDA has established a docket where interested persons may provide comments that could benefit the OCS guidance program and its engagement with stakeholders, including comments on the priority of topics for guidance. This feedback is critical to the OCS guidance program as FDA considers feedback from stakeholders along with agency resources and priorities.
On December 20, 2023, the Centers for Medicare & Medicaid Services (CMS) issued a notice entitled, Charter Renewal for Advisory Committee on Ground Ambulance and Patient Billing (GAPB). The NSA, enacted as part of the CAA, 2021, requires the Secretaries of HHS, Labor, and the Treasury (the Secretaries) to establish and convene an advisory committee, which will be referred to as the GAPB Advisory Committee, for the purpose of reviewing options to improve the disclosure of charges and fees for ground ambulance services, better inform consumers of insurance options for such services, and protect consumers from balance billing. The Secretaries established the GAPB Advisory Committee on November 16, 2021, with a standard 2-year expiration period ending November 16, 2023. In accordance with the Federal Advisory Committee Act (FACA), HHS is hereby giving notice that the charter for the Advisory Committee on Ground Ambulance and Patient Billing (GAPB) was renewed effective November 16, 2023.
On December 20, 2023, FDA issued a notice entitled, Medicare and Medicaid Programs; Application from The Compliance Team (TCT) for Continued Approval of its Rural Health Clinics Program. This proposed notice acknowledges the receipt of an application from the Compliance Team (TCT) for continued recognition as a national accrediting organization (AO) for Rural Health Clinics (RHCs) that wish to participate in the Medicare or Medicaid programs. The statute requires that within 60 days of receipt of an organization’s complete application, CMS will publish a notice that identifies the national accrediting body making the request, describes the nature of the request, and provides at least a 30-day public comment period.
On December 20, 2023, FDA issued a final rule entitled, Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations. The final rule amends FDA’s regulations to implement a provision of the 21st Century Cures Act (Cures Act). This final rule allows an exception from the requirement to obtain informed consent when a clinical investigation poses no more than minimal risk to the human subject and includes appropriate safeguards to protect the rights, safety, and welfare of human subjects. The final rule permits an institutional review board (IRB) to waive or alter certain informed consent elements or to waive the requirement to obtain informed consent, under limited conditions, for certain FDA-regulated minimal risk clinical investigations.
On December 21, 2023, FDA issued guidance entitled, Data Standards for Drug and Biological Product Submissions Containing Real-World Data. This guidance provides recommendations to sponsors to help support compliance with the Federal Food, Drug, and Cosmetic Act (FD&C Act) when submitting study data derived from RWD sources in applicable regulatory submissions using standards specified in the Data Standards Catalog. FDA is publishing this guidance as part of a series of guidance documents under its program to evaluate the use of RWE in regulatory decision making. This guidance finalizes the draft guidance of the same title issued on October 22, 2021.
On December 21, 2023, FDA issued guidance entitled, Digital Health Technologies for Remote Data Acquisition in Clinical Investigations; Guidance for Industry, Investigators, and Other Stakeholders. This guidance provides recommendations on the use of digital health technologies (DHTs) to acquire data remotely from participants in clinical investigations that evaluate medical products. DHTs for remote data acquisition in clinical investigations can include hardware and/or software to perform one or more functions. Use of DHTs as recommended in this guidance may improve the efficiency of clinical trials for sponsors, investigators, and other stakeholders and may increase the opportunities for individuals to participate in research and make participation more convenient. This guidance finalizes the draft guidance of the same title issued on December 23, 2021.
On December 21, 2023, FDA issued guidance entitled, Master Protocols for Drug and Biological Product Development. This draft guidance addresses the design and analysis of trials conducted under a master protocol as well as the submission of documentation to support regulatory review. The primary focus is on randomized umbrella and platform trials that are intended to contribute to a demonstration of safety and substantial evidence of effectiveness. The considerations in this guidance apply to a range of therapeutic areas. The draft guidance is intended to clarify the agency’s thinking on the use of master protocols in drug and biological product development, which was previously addressed in FDA’s guidance entitled, COVID–19: Master Protocols Evaluating Drugs and Biological Products for Treatment or Prevention.
On December 21, 2023, FDA issued guidance entitled, Real-World Data: Assessing Registries To Support Regulatory Decision-Making for Drug and Biological Products. This final guidance provides considerations for sponsors proposing to design a registry or to use an existing registry to support regulatory decision-making about a drug’s effectiveness or safety. FDA is issuing this guidance as part of its RWE Program and to satisfy, in part, the mandate under the FD&C Act to issue guidance on the use of RWE in regulatory decision-making. This guidance finalizes the draft guidance of the same title issued on November 30, 2021.
On December 21, 2023, HHS issued a notice entitled, Notice and Request for Comments on the Implications of Access and Benefit Sharing (ABS) Commitments/Regimes and Other Proposed Commitments Being Considered Under a WHO Convention, Agreement or Other International Instrument on Pandemic Prevention, Preparedness and Response. This Request for Comment seeks information from stakeholders, broadly defined, on concepts currently under consideration by parties negotiating a World Health Organization (WHO) Pandemic Preparedness Agreement. It seeks information on how stakeholders’ efforts to facilitate response efforts, including the rapid creation and equitable deployment of safe and effective vaccines, diagnostic tests, and treatments, can be advanced or hindered by concepts and commitments under consideration by the negotiating parties as reflected in current negotiating text.
On December 22, 2023, CMS issued a proposed rule entitled, Medicare Program: Appeal Rights for Certain Changes in Patient Status. This proposed rule would implement the court order in in Alexander v. Azar, 613 F. Supp. 3d 559 (D. Conn. 2020), aff’d sub nom., Barrows v. Becerra, 24 F.4th 116 (2d Cir. 2022). This order requires HHS to establish appeals processes for certain Medicare beneficiaries who are initially admitted as hospital inpatients but are subsequently reclassified as outpatients receiving observation services during their hospital stay and meet other eligibility criteria.
On December 22, 2023, FDA issued guidance entitled, Rare Diseases: Considerations for the Development of Drugs and Biological Products. This final guidance is intended to assist sponsors of drugs and biological products for treatment of rare diseases in conducting efficient and successful drug development programs through a discussion of selected issues commonly encountered in rare disease drug development. This guidance finalizes the draft guidance entitled Rare Diseases: Common Issues in Drug Development issued on February 1, 2019.
On December 22, 2023, CMS issued a final rule entitled, Clinical Laboratory Improvement Amendments of 1988 (CLIA) Fees; Histocompatibility, Personnel, and Alternative Sanctions for Certificate of Waiver Laboratories. This final rule updates the Clinical Laboratory Improvement Amendments of 1988 (CLIA) fees and clarifies the CLIA fee regulations. This final rule implements a process for sustainable funding for the CLIA program through a biennial two-part increase of CLIA fees. CMS is finalizing the incorporation of limited/specific laboratory fees, including fees for follow up surveys, substantiated complaint surveys, and revised certificates. The rule also finalizes the distribution of the administrative overhead costs of test complexity determination for waived tests and test systems with a nominal increase in Certificate of Waiver (CoW) fees. In addition, the rule finalizes the clarification of the methodology used to determine program compliance fees. This final rule ensures the continuing quality and safety of laboratory testing for the public. This final rule also amends histocompatibility and personnel regulations under CLIA to address obsolete regulations and update the regulations to incorporate technological changes. In addition, this final rule amends the provisions governing alternative sanctions (including civil money penalties, a directed plan of correction, a directed portion of a plan of correction, and onsite State monitoring) to allow for the imposition of such sanctions on CoW laboratories.
Event Notices
January 19, 2024: HHS announced a meeting of the 2023 Dietary Guidelines Advisory Committee. This is a virtual meeting open to the public.
January 19, 2024: The National Institutes of Health (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). This is a virtual meeting open to the public.
January 24, 2024: 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: The Health Resources and Services Administration (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 13-14, 2024: HHS announced a meeting of the Office of Minority Health. The meeting is open to the public. Individuals who wish to attend must register by emailing OMH-ACMH@hhs.gov by 5:00 p.m. EST on January 30, 2024. Each registrant should provide their name, affiliation, phone number, email address, days attending, and if participation is in-person or via webcast.
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.
March 13, 2024: 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.
II. Reports, Studies, & Analyses
On December 19, the Office of Inspector General (OIG) released a report entitled, The Provider Relief Fund Helped Select Nursing Homes Maintain Services During the COVID 19 Pandemic, but Some Found Guidance Difficult to Use. The report studied how 11 nursing homes in six locations used nearly $15 million in allocated funds during 2020 and 2021 to improve their COVID-19 responses. While the funds were vital for maintaining services, nursing home leaders found HRSA’s guidance on allowable uses unclear and challenging to navigate, leading to hesitancy in utilizing the funds. Despite facing distribution and attestation process challenges, nursing homes reported using about $12 million of the allocated funds for expenses and lost revenue. The report recommended that HRSA (1) create a document highlighting lessons learned from managing Provider Relief Fund (PRF) payments and (2) expedite audits of provider use of PRF payments, emphasizing the need for clearer guidance and efficient oversight to optimize fund utilization in the healthcare sector. HRSA concurred with the audit recommendation but did not agree with creating a lessons learned document.
On December 19, the Kaiser Family Foundation (KFF) released a report entitled, Recent Trends in Medicaid Outpatient Prescription Drug Utilization and Spending. The report found that, despite historic levels of Medicaid enrollment during the continuous coverage period, prescription drug utilization has remained below fiscal year (FY) 2017 levels through FY 2022. However, net Medicaid prescription drug spending has experienced a 47 percent increase, rising from $29.8 billion in FY 2017 to $43.8 billion in FY 2022. As states continue the Medicaid unwinding process and grapple with the introduction of new, high-cost drugs, the brief suggests ongoing challenges in managing and mitigating rising Medicaid prescription drug costs. Both states and the federal government are actively implementing measures to address increases in drug spending and costs.
On December 22, 2023, OIG released a report entitled, Medicare Part B Spending on Clinical Diagnostic Laboratory Tests in 2022. This report analyzed Medicare Part B claims data for lab tests in 2022, detailing total spending and key trends, including the top 25 lab tests by total spending and found that the Medicare Part B spending on clinical diagnostic laboratory tests decreased by 10 percent in 2022 compared to 2021. According to the report, this decline was influenced by changes in test volume rather than payment rate adjustments and was observed across various categories of lab tests, including COVID-19, genetic, and chemistry tests. Although most individual lab tests experienced decreases in spending and volume, not all followed this trend. OIG has reported on Medicare Part B lab test spending as mandated by the Protecting Access to Medicare Act of 2014 (PAMA). No recommendations were provided in this data snapshot. PAMA aimed to align Medicare Part B payment rates with private payor rates to manage lab test spending. CMS implemented new payment rates from 2018 to 2020, with delays in rate changes scheduled until January 1, 2026, from 2021 to 2023.
III. Other Health Policy News
On December 18, Senator Bill Cassidy (R-LA), Ranking Member of the Senate Health, Education, Labor and Pensions (HELP) Committee, released a letter entitled, 115 Organizations Call on Congress to Reauthorize PAHPA. In the letter, Ranking Member Cassidy underscored the urgency of reauthorizing the Pandemic and All-Hazards Preparedness Act (PAHPA) as a vital tool to bolster the nation’s readiness during health crises. Despite the HELP committee’s bipartisan approval in July 2023, the legislation has not been fully reauthorized since its expiration on September 30, 2023. With the support of 115 organizations, Ranking Member Cassidy emphasizes the necessity of passing PAHPA into law, citing its critical role in addressing public health emergencies (PHEs), including pandemics and natural disasters. Originally passed in 2006 after the federal response shortcomings during Hurricane Katrina, PAHPA has been previously reauthorized in 2013 and 2019.
On December 18, 2023, the Department of HHS, jointly with the Departments of Labor and the Treasury (Departments), issued a final rule outlining the fees for the Federal IDR process under the NSA, which was enacted as part of the CAA, 2021. The final rule amends existing regulations to provide that the administrative fees charged by the Departments to participate in the Federal IDR process, and the ranges for certified IDR entity fees for single and batched determinations, will be established by the Departments in notice and comment rulemaking (rather than in guidance). Further, the final rule establishes that the certified IDR entity fee ranges will be updated no more frequently than once per calendar year. In its final rule, the Departments are also finalizing an administrative fee amount of $115 per party for disputes initiated on or after the effective date of the final rule. In addition, the Departments are finalizing a certified IDR entity fee range of $200-$840 for single determinations and $268-$1,173 for batched determinations for disputes initiated on or after the effective date of the final rule (January 22, 2024). For batched determinations exceeding 25 dispute line items, the Departments are finalizing that certified IDR entities may set a fixed fee between $75-$250 for each increment of 25 dispute line items included in the batched dispute, beginning with the 26th line item. The final rule is available here. The fact sheet is available here.
On December 19, 2023, House Ways and Means Committee Democrats released additional reports detailing the role the U.S. health system plays in the climate crisis. The report focuses on the health care supply chain and includes a new fact sheet on stakeholder responses related to the environmental impact of pressurized metered dose inhalers. The new materials build on existing materials Committee Democrats previously released to document the ways group purchasing organizations (GPOs) are helping their members respond to extreme weather events. It also included information on the extent to which GPOs are leveraging purchasing power to encourage suppliers to improve their environmental, social, or governance standards. Of note, Committee Democrats reported that the health care supply chain represents 82 percent of total U.S. health sector emissions. Further, Committee Democrats highlighted that the health care industry is responsible for approximately 8.5 percent of greenhouse gas emissions in the country. The press release with the existing and new materials is available here.
On December 21, 2023, the Biden Administration announced initiatives to expand access to naloxone in federal facilities nationwide. HHS and the General Services Administration (GSA) introduced guidelines recommending the inclusion of overdose reversal medications, like naloxone, in safety stations across federal facilities. This step aims to make life-saving medications readily available during emergency situations and follows President Biden’s Unity Agenda to address the overdose crisis comprehensively. The updated guidelines introduce the concept of “safety stations” akin to automated external defibrillator (AED) programs, ensuring quick access to essential tools in federal facilities. These stations will include AEDs as well as opioid reversal agents or hemorrhagic control components. Expanding naloxone access aligns with the National Drug Control Strategy and the Administration’s efforts to address the overdose crisis. The Administration has invested substantially in programs like the State Opioid Response (SOR) grant, enabling states to distribute nearly 9 million naloxone kits, reversing over 500,000 overdoses. Additionally, FDA’s approval of certain naloxone nasal sprays for over-the-counter use and its availability in stores marks a significant milestone in enhancing accessibility. A press release with more information is available here.
On December 22, 2023, the Departments and the Office of Personnel Management announced that they intend to reopen the comment period for the proposed rule entitled, Federal Independent Dispute Resolution (IDR) Operations. The proposed rule proposes new requirements for group health plans and health insurance issuers; providers, facilities, and providers of air ambulance services; and certified IDR entities as they relate to the Federal IDR process under the NSA. The Departments intend to publish a notice in the Federal Register with further details on reopening the comment period. The current deadline is January 2, 2024. The proposed rule is available here. The fact sheet is available here.
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