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 Energy & Commerce Committee held a markup of 16 bills and HRSA wrote a letter to Johnson & Johnson demanding they cease implementation of their 340B rebate model.
I. Regulations, Notices & Guidance
- On September 16, 2024, the Department of Health and Human Services (HHS) released a notice entitled, Requirements Related to the Mental Health Parity and Addiction Equity Act. This document sets forth final rules amending regulations implementing the Paul Wellstone and Pete Domenici Mental Health Parity and Addiction Equity Act of 2008 (MHPAEA) and adding new regulations implementing the nonquantitative treatment limitation (NQTL) comparative analyses requirements under MHPAEA, as amended by the Consolidated Appropriations Act, 2021 (CAA, 2021). Specifically, these final rules amend the existing NQTL standard to prohibit group health plans and health insurance issuers offering group or individual health insurance coverage from using NQTLs that place greater restrictions on access to mental health and substance use disorder (SUD) benefits as compared to medical/surgical benefits. As part of these changes, these final rules require plans and issuers to collect and evaluate relevant data in a manner reasonably designed to assess the impact of NQTLs on relevant outcomes related to access to mental health and SUD benefits and medical/surgical benefits and to take reasonable action, as necessary, to address material differences in access to mental health or SUD benefits as compared to medical/surgical benefits. These final rules also amend existing examples and add new examples on the application of the rules for NQTLs to clarify and illustrate the requirements of MHPAEA. Additionally, these final rules set forth the content requirements for NQTL comparative analyses and specify how plans and issuers must make these comparative analyses available to the Department of the Treasury (Treasury), the Department of Labor (DOL), and HHS, as well as to an applicable State authority, and to participants, beneficiaries, and enrollees. Finally, HHS finalized regulatory amendments to implement the sunset provision for self-funded non-Federal governmental plan elections to opt out of compliance with MHPAEA, as adopted in the Consolidated Appropriations Act, 2023 (CAA, 2023).
- On September 16, 2024, the Centers for Medicare & Medicaid Services (CMS) released a notice entitled, Medicare and Medicaid Programs; Application from the Accreditation Commission for Health Care, Inc. (ACHC) for Continued Approval of its Home Health Agency Accreditation Program. This proposed notice acknowledges the receipt of an application from the Accreditation Commission for Health Care, Inc. (ACHC) for continued recognition as a national accrediting organization for home health agencies (HHAs) 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 must 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 September 16, 2024, the Food and Drug Administration (FDA) released a notice entitled, Medical Devices; Immunology and Microbiology Devices; Classification of the Quantitative Viral Nucleic Acid Test for Transplant Patient Management. FDA is classifying the quantitative viral nucleic acid test for transplant patient management into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the quantitative viral nucleic acid test for transplant patient management’s classification. FDA is taking this action because the agency has determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. FDA believes this action will also enhance patients’ access to beneficial innovative devices.
- On September 16, 2024, FDA released a notice entitled, Chemistry, Manufacturing, and Controls Technical Section Filing Strategies; Draft Guidance for Industry; Availability. This draft guidance provides recommendations to sponsors submitting CMC data submissions to new animal drug applications. This guidance describes the options for soliciting early input from the Center for Veterinary Medicine (CVM) and the process for submission of components of the CMC technical section.
- On September 16, 2024, FDA released a notice entitled, Considerations for Generating Clinical Evidence from Oncology Multiregional Clinical Development Programs; Draft Guidance for Industry; Availability. This draft guidance provides recommendations to sponsors who are planning global clinical development programs for drugs intended to treat cancer, on improving the evidence obtained from one or more multiregional clinical trials (MRCTs) intended to support a marketing application. This draft guidance expands on principles described in FDA’s existing guidance documents related to this topic, by providing additional recommendations for the planning, design, conduct, and analysis of an oncology MRCT under certain conditions.
- On September 17, 2024, CMS released a notice entitled, Medicare Program; Application by the Community Health Accreditation Partner (CHAP) for Continued CMS Approval of Its Home Infusion Therapy (HIT) Accreditation Program. This final notice announces the agency’s decision to approve the Community Health Accreditation Partner (CHAP) 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 September 17, 2024, FDA released a notice entitled, Conducting Clinical Trials With Decentralized Elements; Guidance for Industry, Investigators, and Other Interested Parties Availability. This guidance provides recommendations regarding the implementation of decentralized elements in clinical trials for drugs, biological products, and devices. Decentralized elements allow trial-related activities to occur remotely at locations convenient for trial participants (e.g., telehealth visits with investigators or visits with local healthcare providers (HCPs)). FDA’s regulatory requirements are the same for trials that include decentralized elements and trials that do not include decentralized elements. To help ensure the appropriate oversight trials with decentralized elements, the integrity of trial data, and the safety of trial participants, this guidance covers the responsibilities of sponsors and investigators. This guidance finalizes the draft guidance entitled Decentralized Clinical Trials for Drugs, Biological Products, and Devices issued on May 3, 2023.
- On September 17, 2024, FDA released a notice entitled, Integrating Randomized Controlled Trials for Drug and Biological Products Into Routine Clinical Practice; Draft Guidance for Industry; Availability. This draft guidance is intended to support the conduct of randomized controlled drug trials with streamlined protocols and procedures that can integrate research into routine clinical practice.
- On September 18, 2024, the Centers for Disease Control and Prevention (CDC) released a notice entitled, Reorganization of the Office of Health Equity. CDC has modified its structure. This notice announces the reorganization of the Office of Health Equity (OHE). OHE abolished an office and modified mission and function statements.
- On September 18, 2024, CDC released a notice entitled, Reorganization of the Office of Laboratory Science and Safety. CDC has modified its structure. This notice announces the reorganization of the Office of Laboratory Science and Safety (OLSS). OLSS was retitled to the Office of Laboratory Systems and Response (OLSR) and additional organizational updates were approved.
- On September 18, 2024, CMS released a notice entitled, Medicare Program; Application by The Compliance Team (TCT) for Continued CMS Approval of Its Home Infusion Therapy (HIT) Accreditation Program. This final notice announces CMS’s decision to approve The Compliance Team (TCT) for continued recognition as a national accrediting organization that accredits suppliers of HIT services that wish to participate in the Medicare or Medicaid programs.
- On September 18, 2024, CMS released a notice entitled, Medicare Program; Application by the National Association of Boards of Pharmacy (NABP) for Continued CMS Approval of Its Home Infusion Therapy (HIT) Accreditation Program. This final notice announces CMS’s decision to approve the National Association of Boards of Pharmacy (NABP) for continued recognition as a national accrediting organization that accredits suppliers of HIT services that wish to participate in the Medicare or Medicaid programs.
- On September 18, 2024, FDA released a notice entitled, Fee Rate for Using a Priority Review Voucher in Fiscal Year 2025. FDA is announcing the fee rate for using a priority review voucher for FY 2025. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended, authorizes FDA to determine and collect priority review user fees for certain applications for review of human drug or biological products when those applications use a tropical disease, rare pediatric disease, or material threat medical countermeasure (MCM) priority review voucher. These vouchers are awarded to the sponsors of tropical disease, rare pediatric disease, or material threat MCM product applications, respectively, that meet the requirements of the FD&C Act, upon FDA approval of such applications. The amount of the fee for using a priority review voucher is determined each fiscal year, based on the difference between the average cost incurred by FDA to review a human drug application designated as priority review in the previous fiscal year, and the average cost incurred in the review of an application that is not subject to priority review in the previous fiscal year. This notice establishes the FY 2025 priority review fee rate applicable to submission of eligible applications for review of human drug or biological products using a rare pediatric disease, material threat MCM, or tropical disease priority review voucher and outlines the payment procedures for such fees.
- On September 18, 2024, the Health Resources and Services Administration (HRSA) released 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 HHS is named as the respondent in all proceedings brought by the filing of petitions for compensation under the Program, the U.S. Court of Federal Claims is charged by statute with responsibility for considering and acting upon the petitions.
- On September 18, 2024, HRSA released a notice entitled, Notice of Supplemental Award; Alumni Peer Navigator Services Pilot. HRSA will provide supplemental award funds in FY 2024 to the current recipient of the Supporting Healthy Start (HS) Performance Project cooperative agreement (HRSA-24-038) to support the second year of the Alumni Peer Navigator (APN) Services Pilot.
- On September 19, 2024, FDA released a notice entitled, Regulatory Hearing Before the Food and Drug Administration; General Provisions; Amendments. FDA is issuing a direct final rule amending the Scope section of its regulation that provides for a regulatory hearing before FDA to clarify when such hearings are available. FDA is revising the list of statutory provisions enumerated in the Scope section of the regulation by adding one statutory reference and removing a different statutory reference. FDA is issuing these amendments directly as a final rule because FDA believes they are noncontroversial and anticipates no significant adverse comments.
- On September 19, 2024, FDA released a notice entitled, Chemical Analysis for Biocompatibility Assessment of Medical Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability. FDA is issuing this draft guidance to describe recommended methodological approaches for chemical analysis for biocompatibility assessment of medical devices. The biocompatibility of medical devices is evaluated based on the duration of exposure and nature of contact with the body. Chemical characterization is one approach that manufacturers can consider when developing a strategy for the overall biocompatibility assessment of a device. This draft guidance is not final nor is it for implementation at this time.
- On September 20, 2024, FDA released a notice entitled, Microbiology Devices; Reclassification of Cytomegalovirus Deoxyribonucleic Acid Quantitative Assay Devices Intended for Transplant Patient Management. FDA is issuing a final order to reclassify cytomegalovirus (CMV) deoxyribonucleic acid (DNA) quantitative assay devices intended for transplant patient management, a post amendments class III device (product code PAB) into class II (general controls and special controls), subject to premarket notification.
- On September 20, 2024, FDA released a notice entitled, The Accreditation Scheme for Conformity Assessment Program; Draft Guidances for Industry, Accreditation Bodies, Testing Laboratories, and Food and Drug Administration Staff; Availability. In accordance with amendments made by the FDA User Fee Reauthorization Act of 2022 (FUFRA), part of the Medical Device User Fee Amendments of 2022 (MDUFA V), FDA was directed to conclude the Pilot Accreditation Scheme for Conformity Assessment Program by the end of FY 2023 and continue to operate the program consistent with the amended FD&C Act. These draft guidance documents are not final nor for implementation at this time.
- On September 20, 2024, CMS released a notice entitled, Medicaid Program; Misclassification of Drugs, Program Administration and Program Integrity Updates Under the Medicaid Drug Rebate Program. This final rule implements policies in the Medicaid Drug Rebate Program (MDRP) related to the new legislative requirements in the Medicaid Services Investment and Accountability Act of 2019 (MSIAA), which address drug misclassification, as well as drug pricing and product data misreporting by manufacturers. Additionally, CMS is finalizing several other proposed program integrity and program administration provisions or modifications in this final rule, including revising and finalizing key definitions used in the MDRP. This rule also finalizes a provision not directly related to MDRP that makes revisions to the third-party liability regulation due to amendments made by the Bipartisan Budget Act (BBA) of 2018. CMS is finalizing a proposal to rescind revisions made by the December 31, 2020 final rule Medicaid Program; Establishing Minimum Standards in Medicaid State Drug Utilization Review (DUR) and Supporting Value-Based Purchasing (VBP) for Drugs Covered in Medicaid, Revising Medicaid Drug Rebate and Third Party Liability (TPL) Requirements (“the 2020 final rule”) to the Determination of Best Price and Determination of Average Manufacturer Price (AMP) sections.
Event Notices
September 23, 2024: HHS announced a meeting of the President’s Advisory Commission on Asian Americans, Native Hawaiians, and Pacific Islanders. This is a hybrid meeting open to the public.
September 23, 2024: The National Institutes of Health (NIH) announced a meeting of the Center for Scientific Review. This is a hybrid meeting open to the public.
September 23, 2024: NIH announced a meeting of the Office of the Secretary. This is a virtual meeting open to the public.
September 23, 2024: CDC announced a meeting of the World Trade Center Health Program Scientific/Technical Advisory Committee. This is a virtual meeting open to the public.
September 25-26, 2024: HHS announced a meeting of the 2025 Dietary Guidelines Advisory Committee. This is a virtual meeting open to the public.
September 26, 2024: FDA announced a meeting of the Oncologic Drugs Advisory Committee. This is a hybrid meeting open to the public.
October 7, 2024: FDA announced a meeting of the Science Board to the FDA. This is a virtual meeting open to the public.
October 8, 2024: NIH announced a meeting of the NIH Office of the Director. This is a virtual meeting open to the public.
October 10, 2024: FDA announced a meeting of the Cardiovascular and Renal Drugs Advisory Committee. This is a hybrid meeting open to the public.
October 16-17: HRSA announced a meeting of the Advisory Committee on Infant and Maternal Mortality (ACIMM). This is a hybrid meeting open to the public.
October 16-17, 2024: CDC announced a meeting of the Community Preventive Services Task Force. 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 Sexually Transmitted Disease (STD) Prevention and Treatment. This is a hybrid meeting open to the public.
October 22, 2024: CDC announced a meeting of the Advisory Committee to the Director (ACD). 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.
October 30, 2024: FDA announced a meeting of the Patient Engagement Advisory Committee. This is a virtual meeting open to the public.
November 6, 2024: CDC announced a meeting of the Clinical Laboratory Improvement Advisory Committee. This is a virtual meeting open to the public.
November 7, 2024: CDC announced a meeting of the Mine Safety and Health Research Advisory Committee. This is a hybrid meeting open to the public.
November 15, 2024: HRSA announced a meeting of the Advisory Committee on Training in Primary Care Medicine and Dentistry. This is a virtual meeting open to the public.
II. Hearings & Markups
- On September 17, 2024, the Senate Finance Committee held a hearing entitled, Lower Health Care Costs for Americans: Understanding the Benefits of the Inflation Reduction Act. Witnesses included: Judy Aiken, Retired Registered Nurse; Jeanne Lambrew, Ph.D., Director of Health Care Reform and Senior Fellow, The Century Foundation; Rena Conti, Ph.D., Dean’s Research Scholar and Associate Professor, Markets, Public Policy and Law, Questrom School of Business, Boston University; Kirsten Axelsen, Nonresident Fellow at the American Enterprise Institute and Senior Policy Advisor at DLA Piper; and, Theo Merkel, Senior Research Fellow at the Paragon Health Institute and Senior Fellow at The Manhattan Institute, New York, NY.
- On September 18, 2024, the House Energy & Commerce held a full Committee markup of 16 bills. Legislation considered included: H.R. 8449, AM Radio for Every Vehicle Act; H.R. 7891, Kids Online Safety Act; H.R. 7890, Children and Teens’ Online Privacy Protection Act; H.R. 670, Think Differently Database Act; H.R. 8107, Ensuring Access to Medicaid Buy-in Programs Act of 2024; H.R. 8108, To amend title XIX of the Social Security Act to add a Medicaid State plan requirement with respect to the determination of residency of certain individuals serving in the Armed Forces; H.R. 3433, Give Kids a Chance Act of 2024; H.R. 7188, Shandra Eisenga Human Cell and Tissue Product Safety Act; H.R. 7623, Telehealth Modernization Act of 2024; H.R. 3227, Ensuring Seniors’ Access to Quality Care Act; H.R. 9067, Building America’s Health Care Workforce Act; H.J. Res. 139, Providing for congressional disapproval under chapter 8 of title 5, United States Code, of the rule submitted by the Centers for Medicare & Medicaid Services relating to "Medicare and Medicaid Programs: Minimum Staffing Standards for Long-Term Care Facilities and Medicaid Institutional Payment Transparency Reporting”; H.J.Res. 163, Providing for congressional disapproval under chapter 8 of title 5, United States Code, of the rule submitted by the Environmental Protection Agency relating to “New Source Performance Standards for Greenhouse Gas Emissions From New, Modified, and Reconstructed Fossil Fuel-Fired Electric Generating Units; Emission Guidelines for Greenhouse Gas Emissions From Existing Fossil Fuel-Fired Electric Generating Units; and Repeal of the Affordable Clean Energy Rule”; H.J.Res. 133, Providing for congressional disapproval under chapter 8 of title 5, United States Code, of the rule submitted by the Environmental Protection Agency relating to "Greenhouse Gas Emissions Standards for Heavy-Duty Vehicles-Phase 3"; and, H.J.Res. 117, Providing for congressional disapproval under chapter 8 of title 5, United States Code, of the rule submitted by the Environmental Protection Agency relating to "Reconsideration of the National Ambient Air Quality Standards for Particulate Matter". Notably, H.R. 7623, Telehealth Modernization Act of 2024, was reported to the full House, as amended, by a roll call vote of 41 to 0.
- On September 18, 2024, the House Ways & Means Health Subcommittee held a hearing entitled, Investing in a Healthier America: Chronic Disease Prevention and Treatment. Witnesses included: Senator Bill Frist, Former United States Senate Majority Leader, Chairman of the Executives Council, Cressey & Company; Dr. Mark Hyman, M.D., Founder, Institute for Functional Health; Dr. Anne Peters, M.D., Senior Scholar, USC Schaeffer Institute; Dr. Francesca Rinaldo, M.D., Chief Clinical Innovation Officer, Senior Care Action Network (SCAN) Health Plan; and Dr. Ashley Gearhardt, Professor of Psychology, Food and Addiction Science and Treatment, University of Michigan.
III. Reports, Studies, & Analyses
- On September 17, 2024, HHS released a progress report on federal efforts to implement the 2022 National Strategy to Support Family Caregivers entitled, 2024 Federal Progress Report: Federal Implementation of the 2022 National Strategy to Support Family Caregivers. The report highlights that almost all of the 350 actions outlined in the strategy have been completed or are underway, with an additional 40 actions committed since the strategy’s release. The report underscores the Biden Administration’s initiatives to enhance caregiver support across various sectors, addressing the critical role caregivers play in providing long-term care and their need for adequate resources and support.
- On September 17, 2024, the U.S. Government Accountability Office (GAO) released a report entitled, Older Americans Act: Agencies Should Take Steps to Better Manage Fraud Risks. In this report, GAO asserted that HHS and DOL have not adequately addressed fraud risks in their Older Americans Act programs. Despite managing billions in grants, these agencies have not conducted formal fraud risk assessments. The GAO made 14 recommendations, urging both agencies to designate entities responsible for fraud oversight and to implement comprehensive fraud risk assessments. Key recommendations include assigning specific fraud oversight responsibilities, conducting formal fraud risk assessments, and creating action plans to mitigate potential risks. It also emphasizes the need for better monitoring, reporting mechanisms, and coordination with stakeholders to identify vulnerabilities and prevent misuse of program funds. In the report, the agencies are encouraged to implement these strategies to protect resources as demands increase.
- On September 17, 2024, the Office of the Inspector General (OIG) released a report entitled, Medicare Part B Drug Payments: Impact of Price Substitutions Based on 2022 Average Sales Prices. In this report, OIG reviewed Medicare Part B drug payments and the impact of price substitutions based on 2022 data. Since 2013, price substitutions have saved Medicare and its enrollees over $74.3 million, including $966,307 in 2022. OIG found that CMS could achieve more savings—up to $8.5 million—by expanding its criteria for price substitutions. Additionally, errors in manufacturer price data hindered determining price substitutions for 30 drugs. OIG recommended that CMS expand its criteria and address data issues.
IV. Other Health Policy News
- On August 27, Johnson & Johnson (J&J) stated its intent to proceed with its rebate model, and on September 17, 2024, HRSA sent a warning letter to J&J stating that its unapproved rebate proposal violated statutory obligations under the 340B Program. HRSA directed the company to cease implementation of this proposal by September 30, 2024, or J&J would be subject to potential consequences such as termination of its Pharmaceutical Pricing Agreement and the imposition of civil monetary penalties (CMPs). In the meantime, Representatives Debbie Dingell (D-MI), Abigail Spanberger (D-VA), Dusty Johnson (R-SD), Doris Matsui (D-CA), Tracey Mann (R-KS), and Rob Wittman (R-VA) released a Dear Colleague letter seeking signatures on a bipartisan letter to HHS Secretary Xavier Becerra expressing concern about J&J’s efforts to replace 340B drug discounts with rebates for disproportionate share hospitals. The letter from HRSA to J&J is available here.
- On September 17, 2024, the Biden Administration announced nearly $100 million to strengthen the health workforce, focusing on primary care in underserved areas and addressing the opioid crisis. Of this, nearly $12 million is directed to three medical schools to increase the number of primary care physicians in rural and tribal communities. Additionally, over $63 million will support training peer support specialists and community-based providers to offer mental health services and family support for children affected by opioid and SUDs. These efforts aim to improve care access and address workforce shortages in critical areas. A press release with more information is available here.
- On September 17 and 18, 2024, the House of Representatives passed H.R. 4758, the Accelerating Kids Access to Care Act, legislation which would streamline the process for Medicaid and Children’s Health Insurance Program (CHIP) providers to treat out-of-state pediatric patients. The bill proposes to allow states to waive Medicaid provider screening requirements if an out-of-state provider already meets the requirement of their state. The bill would also prohibit PBMs from engaging in “spread pricing” practices, in which PBMs charge health plans more for a drug than they reimburse to pharmacies and retain the difference, in Medicaid programs. Additionally, the House passed H.R. 3800, the Chronic Disease Flexibility Act, which would codify guidance from the Internal Revenue Service (IRS) issued in 2019 that allows for high-deductible health plans (HDHPs) that are linked to health savings accounts (HSAs) to cover certain treatments and services without a deductible, including medications and monitoring devices to manage chronic conditions such as diabetes or heart conditions.
- On September 19, 2024, the Biden Administration announced $240 million in funding to integrate mental health and SUD treatment into primary care at over 400 community health centers (CHCs). These CHCs, serving more than 10 million patients, will expand access to behavioral health services, addressing the mental health and opioid crises. This initiative supports the Administration’s Unity Agenda by making mental health services more accessible, particularly in underserved communities. The Administration is pushing for further congressional action to make these services a requirement at all HRSA-supported CHCs nationwide. A press release with more information is available here.
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