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 finalized the Transitional Coverage for Emerging Technologies (TCET) pathway for Medicare coverage of breakthrough medical technologies and HRSA announced funding for health centers to bolster cancer care.

I. Regulations, Notices & Guidance

• On August 5, 2024, the Administration for Community Living (ACL) released a notice entitled, Announcing the Intent to Award a Single-Source Supplement for the National Center for Benefits Outreach and Enrollment (NCBOE). ACL is announcing the intent to award a single-source supplement to the current cooperative agreement held by the National Council on Aging (NCOA) for the National Center for Benefits Outreach and Enrollment (NCBOE). The purpose of the NCBOE is to provide technical assistance to states, Area Agencies on Aging, Aging and Disability Resource Centers and community-based organizations who conduct outreach and low-income benefits enrollment assistance, particularly to older individuals with greatest economic need for federal and state programs. The administrative supplement for FY 2024 will be for $3,207,650, bringing the total award for FY 2024 to $14,707,650.
• On August 5, 2024, the Centers for Medicare & Medicaid Services (CMS) issued a final rule correcting amendment entitled, Medicare Program; Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Program for Contract Year 2024—Remaining Provisions and Contract Year 2025 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit Program, Medicare Cost Plan Program, and Programs of All-Inclusive Care for the Elderly (PACE); Correcting Amendment. This document corrects technical and typographical errors in the final rule that appeared in the April 23, 2024 Federal Register entitled, “Medicare Program; Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Program for Contract Year 2024—Remaining Provisions and Contract Year 2025 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit Program, Medicare Cost Plan Program, and Programs of All-Inclusive Care for the Elderly (PACE).” The effective date of the final rule was June 3, 2024.
• On August 7, 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, as required by the Public Health Service (PHS) Act, as amended. While the Secretary of the Department of Health and Human Services (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 August 7, 2024, HRSA released a notice entitled, Alliance for Innovation on Maternal Health – Community Care Initiative (AIM CCI)/ Non-Competitive Supplement. HRSA is providing non-competitive supplemental funds in fiscal year (FY) 2024 to pilot test community-based methods and/or maternal safety bundles to address hypertension during pregnancy and the postpartum period to improve maternal health.
• On August 7, 2024, HHS issued a final rule entitled, Annual Civil Monetary Penalties Inflation Adjustment. HHS is updating its regulations to reflect required annual inflation-related increases to the civil monetary penalty (CMP) amounts in its statutes and regulations under the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015.
• On August 7, 2024, the Food and Drug Administration (FDA) released a notice entitled, Antimicrobial Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments--New Drug Application 213972 for Sulopenem Etzadroxil/Probenecid Tablets. FDA is announcing a forthcoming public advisory committee meeting of the Antimicrobial Drugs Advisory Committee. The general function of the Committee is to provide advice and recommendations to FDA on regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.
• On August 7, 2024, FDA released a notice entitled, Advisory Committee; Blood Products Advisory Committee; Renewal. FDA is announcing the renewal of the Blood Products Advisory Committee by the Commissioner of Food and Drugs. The Commissioner has determined that it is in the public interest to renew the Blood Products Advisory Committee for an additional two years beyond the charter expiration date. The new charter will be in effect until the May 13, 2026, expiration date.
• On August 7, 2024, FDA released a notice entitled, Amending Over-the-Counter Monograph M013: Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use; Reopening the Comment Period. FDA is reopening the comment period for the proposed administrative order entitled, “Amending Over-the-Counter Monograph M013: Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use,” announced in the Federal Register on June 14, 2024.
• On August 8, 2024, CMS issued a final notice entitled, Medicare Program; Transitional Coverage for Emerging Technologies. This final notice finalizes the process and procedures for the Transitional Coverage for Emerging Technologies (TCET) pathway and provides our responses to the public comments received.
• On August 8, 2024, FDA issued guidance entitled, Food and Drug Administration Enforcement Policy for Association of American Feed Control Officials-Defined Animal Feed Ingredients; Draft Guidance for Industry; Availability. FDA is announcing the availability of a draft guidance for industry (GFI) #293 entitled, “FDA Enforcement Policy for AAFCO-Defined Animal Feed Ingredients.” This draft guidance, when finalized, will communicate FDA’s enforcement policy regarding ingredients listed in chapter six of the 2024 Association of American Feed Control Officials (AAFCO) Official Publication (OP) after the expiration of the Agency’s memorandum of understanding (MOU) with AAFCO. The current MOU, which expires in October 2024, will not be renewed.
• On August 8, 2024, FDA issued guidance entitled, Animal Food Ingredient Consultation; Draft Guidance for Industry; Availability. FDA is announcing the availability of draft GFI #294 entitled, “Animal Food Ingredient Consultation (AFIC).” This draft guidance describes FDA’s interim AFIC process and explains one way FDA intends to work with firms that are developing animal food ingredients after the MOU with AAFCO expires on October 1, 2024, and while FDA evaluates the animal Food Additive Petition and generally recognized as safe (GRAS) notification programs. The new AFIC process will provide an additional way for engagement with FDA regarding ingredients for which firms may otherwise have used the AAFCO ingredient definition process. AFIC will help FDA identify any potential safety concerns associated with such ingredients. The AFIC process will also allow for public awareness of and input on such ingredients. In addition, this draft guidance describes FDA’s enforcement policy for certain ingredients assessed using the AFIC process.
• On August 8, 2024, FDA issued guidance entitled, Bacillus Calmette-Guérin-Unresponsive Non-muscle Invasive Bladder Cancer: Developing Drug and Biological Products for Treatment; Revised Draft Guidance for Industry; Availability. FDA is announcing the availability of a draft GFI entitled, “Bacillus Calmette-Guérin-Unresponsive Non-muscle Invasive Bladder Cancer: Developing Drug and Biological Products for Treatment.” The purpose of this guidance is to assist sponsors in the development of drug and biological products for the treatment of patients with bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC). This draft guidance reflects proposed revisions to the final guidance entitled, “BCG-Unresponsive Non-muscle Invasive Bladder Cancer: Developing Drugs and Biologics for Treatment,” published in February 2018, and incorporates changes based on review experience as well as the evolving landscape of drug development in bladder cancer.
• On August 8, 2024, FDA issued guidance entitled, Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases; Guidance for Industry; Availability. FDA is announcing the availability of a final GFI entitled, “Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases.” This guidance is intended to assist sponsors in identifying an optimized dosage(s) for human prescription drugs or biological products for the treatment of oncologic diseases during clinical development prior to submitting an application for approval for a new indication and usage. This guidance does not address selection of the starting dosage for first-in-human trials. In addition, this guidance does not address dosage optimization for radiopharmaceuticals, cellular and gene therapy products, oncolytics, microbiota, or cancer vaccines, nor does it specifically address pediatric drug development. However, some of the principles outlined may be applicable to these therapeutic modalities or to dosage optimization for pediatric patients. This guidance finalizes the draft guidance of the same title “Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases,” issued on January 23, 2023.
• On August 8, 2024, FDA released a notice entitled, Pre-Market Animal Food Ingredient Review Programs; Request for Comments. FDA is soliciting comments from the public regarding the Food Additive Petition and GRAS notification programs to determine if changes are needed to promote their efficiency. Specific questions and information requests are included in this notice to help guide input from stakeholders and other members of the public.
• On August 8, 2024, HHS issued a proposed rule entitled, HHS Acquisition Regulation: Acquisition of Information Technology; Standards for Health Information Technology (HHSAR Case 2023-001). HHS is proposing to amend and update its HHS Acquisition Regulation (HHSAR). These changes will implement requirements to procure health information technology (health IT) that meets standards and implement specifications adopted by the Office of the National Coordinator for Health Information Technology (ONC) in the following parts: Acquisition of Information Technology, Solicitation Provisions, and Contract Clauses.
• On August 9, 2024, HRSA released a notice entitled, Notice of Supplemental Award; Early Childhood Developmental Health Systems Program. HRSA is providing supplemental award funds in FY 2024 to the current recipient of the Early Childhood Developmental Health Systems Program (ECDHS) cooperative agreement (HRSA-22-091) to support existing activities relating to early childhood developmental health services.
• On August 9, 2024, HRSA released a notice entitled, Notice of Supplemental Award; Infant-Toddler Court Program – National Resource Center. HRSA is providing up to $1,750,000 in supplemental award funds in FY 2024 to the current recipient of the Infant-Toddler Court Program (ITCP) – National Resource Center (NRC) award to expand activities to help lead nationwide improvements to child welfare and early childhood systems.

Event Notices

August 22, 2024: 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: The Centers for Disease Control and Prevention (CDC) announced a meeting of the Board of Scientific Counselors, National Institute for Occupational Safety and Health (NIOSH). This is a hybrid meeting open to the public.

August 22, 2024: CDC announced a meeting of the Healthcare Infection Control Practices Advisory Committee. This is a virtual meeting open to the public.

August 26-27, 2024: 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 27, 2024: SAMHSA announced a meeting of the Advisory Committee for Women’s Services (ACWS). This is a virtual 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: 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 6, 2024: FDA announced a workshop entitled, Enhancing Diversity in Therapeutics Development for Pediatric Patients. This is a hybrid 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 11, 2024: The National Institutes of Health (NIH) announced a meeting of the National Institute on Drug Abuse. This is a hybrid meeting open to the public.

September 13, 2024: CDC announced a meeting of the Advisory Committee on Breast Cancer in Young Women. This is a hybrid meeting open to the public. Registration is required.

September 17, 2024: NIH announced a meeting of the Scientific Advisory Committee on Alternative Toxicological Methods. This is a hybrid 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 Sexually Transmitted Disease (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. Reports, Studies, & Analyses

• On August 8, 2024, the Kaiser Family Foundation (KFF) released a report entitled, Use of Prior Authorization in Medicare Advantage Exceeded 46 Million Requests in 2022. The report finds that in 2022, Medicare Advantage (MA) insurers received over 46 million prior authorization requests, a significant increase from 37 million requests in 2019. This increase in requests was largely due to growing enrollment, as the rate of requests per enrollee remained stable at 1.7. However, KFF finds that the denial rate rose to 7.4 percent in 2022, up from 5.7 percent in 2019. Only 9.9 percent of denials were appealed, though this represented an increase from 2019. Notably, 83.2 percent of appeals resulted in overturning the initial denial, potentially indicating delays in necessary care. The use of prior authorization varied among insurers, affecting enrollees' experiences differently depending on their chosen plan.
• On August 8, 2025, the Government Accountability Office (GAO) released a report entitled, Kidney Transplants: Medicare Coverage of Immunosuppressive Drugs. In the report, GAO details Medicare's immunosuppressive drug benefit and highlights the implementation of a new Medicare benefit for kidney transplant patients, effective January 2023. The report states that the benefit helps eligible patients cover immunosuppressive drug costs, with CMS monitoring patient eligibility and compliance. As of February 2024, 104 patients were enrolled, with additional oversight measures in place to ensure correct enrollment and prevent issues like nonpayment of premiums. The report provides detailed insights into CMS's efforts to manage and evaluate the benefit, including steps for verifying patient eligibility, tracking compliance, and addressing potential issues like premium nonpayment. The report also covers the oversight mechanisms CMS has put in place to monitor the benefit's implementation and effectiveness, ensuring that it meets its intended goals and adheres to regulatory requirements.

III. Other Health Policy News

• On August 7, 2024, the Biden Administration announced that HRSA awarded nearly $9 million to HRSA-funded health centers to mark National Health Center Week. The awards will facilitate partnerships between health centers and National Cancer Institute-Designated Cancer Centers to improve access to cancer screenings and treatment in underserved communities. Additionally, funding will support outreach specialists and patient navigators to enhance early cancer detection and expedite access to care, particularly in communities facing significant health disparities. These efforts are part of the Biden Administration’s broader Cancer Moonshot initiative to reduce the cancer death rate by 50 percent over 25 years and improve the experience of cancer patients, building on previous investments totaling $16 million in 2022 and 2023. A press release with more information, including a list of awardees, is available here.
• On August 7, 2024, CMS issued a final procedural notice detailing the TCET Pathway. This pathway is designed to ensure timely and predictable access to new medical technologies for Medicare beneficiaries, focusing on FDA-designated Breakthrough Devices. The TCET Pathway will expedite Medicare coverage through an enhanced and transparent national coverage determination (NCD) process, with a goal to finalize NCDs within six months after FDA market authorization. The pathway aims to balance early access to innovations while ensuring safety and efficacy through evidence development and collaboration with manufacturers. The TCET Pathway allows for up to five devices to be accepted annually, providing manufacturers with a more predictable coverage review process and encouraging innovation. The pathway includes steps such as an Evidence Preview and an Evidence Development Plan (EDP) to address any gaps in clinical evidence.
• CMS has made several adjustments to the TCET process in response to public feedback, intended to improve both the nomination process and overall transparency. One notable change is the introduction of an earlier nomination period for manufacturers, allowing them to submit a non-binding letter of intent approximately 18 to 24 months before they anticipate FDA marketing authorization. To enhance transparency, CMS is now requiring interim reporting within EDPs to ensure that studies are making adequate progress and that any significant changes to the study protocols are disclosed. Additionally, CMS will now post an evidence summary, including details about the contractor responsible for the review, on the CMS website along with the tracking sheet when an NCD is opened. CMS has also introduced quarterly reviews for TCET nominations to provide a more structured and predictable timeline for manufacturers. CMS also expressed its intent to release proposed factors for prioritizing TCET nominations, aiming to offer greater transparency, consistency, and predictability in the nomination process. Finally, CMS will be adding information about TCET devices to the NCD Dashboard, which will include details such as the number of devices in the TCET pathway, the nomination date, acceptance date, and the initiation date of the NCD process. This dashboard will be updated regularly to keep stakeholders informed. The pathway is expected to last approximately five years per device, with ongoing evaluation to ensure continued appropriateness of coverage. A fact sheet with more information is available here.

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