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 negotiated prices under Medicare Part D for 10 high cost drugs, and ARPA-H awarded $150 million to eight research centers as part of the Cancer Moonshot initiative.

I. Regulations, Notices & Guidance

• On August 12, 2024, the Agency for Healthcare Research and Quality (AHRQ) released a notice entitled, Supplemental Evidence and Data Request on Environmental, Clinical and Economic Outcomes of Hospital Resources to Prevent Hospital-Acquired Infections. AHRQ is seeking scientific information submissions from the public. AHRQ is soliciting scientific information to inform their review on Environmental, Clinical and Economic Outcomes of Hospital Resources to Prevent Hospital-Acquired Infections, 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 Access to published and unpublished pertinent scientific information will improve the quality of this review.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 August 12, 2024, the Food and Drug Administration (FDA) released a notice entitled, Advisory Committee; Peripheral and Central Nervous System Drugs Advisory Committee; Renewal. FDA is announcing the renewal of the Peripheral and Central Nervous System Drugs Advisory Committee by the Commissioner of Food and Drugs. The Commissioner of Food and Drugs has determined that it is in the public interest to renew the Peripheral and Central Nervous System Drugs Advisory Committee for an additional 2 years beyond the charter expiration date. The new charter will be in effect until the June 4, 2026, expiration date.
• On August 13, 2024, FDA released a notice entitled, International Drug Scheduling; Single Convention on Narcotic Drugs; Convention on Psychotropic Substances; Hexahydrocannabinol; N-Pyrrolidino Protonitazene (Protonitazepyne); N-Pyrrolidino Metonitazene (Metonitazepyne); N-Piperidinyl Etonitazene (Etonitazepipne); N-Desethyl-isotonitazene; 3-Hydroxy-phencyclidine; N-Ethylheptedrone; Carisoprodol; Request for Comments. FDA is inviting interested persons to submit comments concerning abuse potential, actual abuse, medical usefulness, trafficking, and impact of scheduling changes on availability for medical use of eight drug substances. These comments will be considered in preparing a response from the U.S. to the World Health Organization (WHO) regarding the abuse liability and diversion of these drugs. WHO will use this information to consider whether to recommend that certain international restrictions be placed on these drug substances. This notice requesting comments is required by the Controlled Substances Act (CSA).
• On August 14, 2024, FDA released a notice entitled, Determination of Regulatory Review Period for Purposes of Patent Extension; MIEBO. FDA has determined the regulatory review period for MIEBO and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.
• On August 14, 2024, FDA released a notice entitled, Cubist Pharmaceuticals LLC; Withdrawal of Approval of a New Drug Application for ENTEREG (Alvimopan) Capsules, 12 Milligrams. FDA is withdrawing approval of a new drug application (NDA) for ENTEREG (alvimopan) Capsules, 12 milligrams (mg), held by Cubist Pharmaceuticals LLC, 126 East Lincoln Ave., Rahway, NJ 07065 (Cubist). Cubist notified FDA in writing that the drug product was no longer marketed and requested that the approval of the application be withdrawn.
• On August 15, 2024, FDA released a final order entitled, Medical Devices; General Hospital and Personal Use Devices; Classification of the Intravenous Catheter Force-Activated Separation Device. FDA is classifying the intravenous catheter force-activated separation device 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 intravenous catheter force-activated separation device’s classification. FDA is taking this action because FDA 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 August 15, 2024, FDA released a final order entitled, Medical Devices; Immunology and Microbiology Devices; Classification of the Device To Detect and Identify Nucleic Acid Targets Including SARS-CoV-2 in Respiratory Specimens. FDA is classifying the device to detect and identify nucleic acid targets in respiratory specimens from microbial agents that cause the SARS-CoV-2 respiratory infection and other microbial agents when in a multitarget test 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 device to detect and identify nucleic acid targets in respiratory specimens from microbial agents that cause the SARS CoV-2 respiratory infection and other microbial agents when in a multi-target test’s classification. FDA is taking this action because FDA 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 August 15, 2024, FDA released a final order entitled, Medical Devices; Immunology and Microbiology Devices; Classification of the Device to Detect and Identify Selected Microbial Agents That Cause Acute Febrile Illness. FDA is classifying the device to detect and identify selected microbial agents that cause acute febrile illness 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 device to detect and identify selected microbial agents that cause acute febrile illness’s classification. FDA is taking this action because FDA 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 August 15, 2024, FDA issued a proposed rule entitled, Submission of Food and Drug Administration Import Data in the Automated Commercial Environment for Certain Tobacco Products. FDA, with the Department of the Treasury’s concurrence, proposes amending its regulations to require that the Submission Tracking Number for Electronic Nicotine Delivery System tobacco products that are being imported or offered for import be submitted in the Automated Commercial Environment or any other electronic data interchange system authorized by U.S. Customs and Border Protection, at the time of entry.
• On August 15, 2024, FDA released guidance entitled, Voluntary Sodium Reduction Goals: Target Mean and Upper Bound Concentrations for Sodium in Commercially Processed, Packaged, and Prepared Foods; Draft Guidance for Industry (Edition 2); Availability. FDA is announcing the availability of a draft guidance for industry entitled “Voluntary Sodium Reduction Goals: Target Mean and Upper Bound Concentrations for Sodium in Commercially Processed, Packaged, and Prepared Foods (Edition 2).” The draft guidance, when finalized, will describe FDA’s views on the next voluntary goals (Phase II (3-year)) for sodium reduction in a variety of identified categories of foods that are commercially processed, packaged, or prepared. These goals are intended to address the excessive intake of sodium in the current population to help reduce the burden of diet-related chronic disease, promote improvements in public health, and advance health equity by supporting a healthier food supply.
• On August 15, 2024, the Department of Health and Human Services (HHS) released a semiannual regulatory agenda entitled, Regulatory Agenda. The Regulatory Flexibility Act of 1980 and Executive Order (EO) 12866 require the semiannual issuance of an inventory of rulemaking actions under development throughout HHS, offering for public review summarized information about forthcoming regulatory actions.
• On August 16, 2024, the Health Resources and Services Administration (HRSA) released a notice entitled, Notice of Supplemental Award; Infant-Toddler Court Program – State Awards. HRSA is providing supplemental award funds to the current Infant-Toddler Court Program (ITCP) – State Awards recipients in federal fiscal year (FY) 2024 to support the continuation and expansion of existing activities to build state and local capacity and implement the infant-toddler court approach.
• On August 16, 2024, HRSA released a notice entitled, National Practitioner Data Bank: Change in User Fee for Self-Query Mailed Paper Copies. HRSA is announcing a change in user fees charged to individuals requesting a supplemental mailed paper copy of their National Practitioner Data Bank (NPDB) self-query results. The supplemental fee will increase from $3.00 to $13.00 per mailed paper copy as these copies will be provided using U.S. Postal Service certified mail. The user fees for one-time query, continuous, and digitally certified self-query results will remain unchanged. The fee increase for mailed paper self-query results will be effective October 1, 2024.
• On August 16, 2024, HHS issued a final rule entitled, Supporting the Head Start Workforce and Consistent Quality Programming. This final rule makes regulatory changes to the Head Start Program Performance Standards (HSPPS) to support and stabilize the Head Start workforce and improve the quality of services Head Start programs provide to children and families. These changes include requirements for wages and benefits, breaks for staff, and enhanced support for staff health and wellness. The changes also include enhancements to mental health services to better integrate mental health into every aspect of program service delivery. Enhancements are also included in the areas of family service worker family assignments, identifying and meeting community needs, ensuring child safety, services for pregnant women and other pregnant people, and alignment with State early childhood systems. Finally, the changes include minor clarifications to promote better transparency and clarity of understanding for grant recipients.

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: The Centers for Medicare & Medicaid Services (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.
• August 29, 2024: HHS announced a meeting of the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria. This is a virtual meeting open to the public.
• September 4-6, 2024: HRSA announced a meeting of the National Advisory Committee on Rural Health and Human Services. This is a hybrid 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 7, 2024: FDA announced a meeting of the Science Board to the Food and Drug Administration. This is a virtual meeting open to the public.
• October 8, 2024: NIH announced a meeting of the Office of the Director, National Institutes of Health; Notice of Meeting. 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 15, 2024, the Government Accountability Office (GAO) released a study entitled, Medical Devices: FDA Has Begun Building an Active Postmarket Surveillance System. The report examines FDA’s efforts to establish an active postmarket surveillance system for medical devices, as mandated by federal law in 2012. GAO reviewed FDA documentation, interviewed FDA officials and various stakeholders, including health systems, research organizations, and associations representing device manufacturers, healthcare providers, and patients. The report highlights a 2018 study that linked over 1.7 million injuries and 83,000 deaths to potentially faulty medical devices over a 10-year period in the U.S. GAO found that FDA has taken significant steps to implement the surveillance system, including establishing a coordinating center in 2016 to organize a network of data sources and completing a cloud-based data infrastructure in 2021 to collect evidence of medical device performance while protecting patient privacy. Furthermore, FDA is planning to begin active postmarket surveillance of two medical devices by December 2024, with plans to expand over five years.
• On August 16, 2024, the Kaiser Family Foundation released a report entitled, A Look at Variation in Medicaid Spending Per Enrollee by Group and Across States. The report analyzes Medicaid spending per enrollee for full-benefit recipients across different eligibility groups and states, using data from 2021. Key findings include a national average Medicaid spending of $7,593 per enrollee, with significant variations among eligibility groups and states. Seniors and individuals with disabilities accounted for 21 percent of enrollment but 52 percent of spending, with per-enrollee costs about six times higher than those for children. State-level spending ranged from $3,750 to $12,425 per enrollee, reflecting differences in state policies, demographics, and healthcare markets. The report also highlights considerable variation within eligibility groups across states, with the widest range observed for individuals with disabilities. Additionally, the study found that states that expanded Medicaid generally had higher per-enrollee spending across all eligibility groups compared to non-expansion states.

III. Other Health Policy News

• On August 15, 2024, CMS announced the maximum fair prices for 10 high cost drugs, as part of the Inflation Reduction Act of 2022 (IRA) drug negotiations. The negotiated prices for Medicare Part D beneficiaries will go into effect on January 1, 2026. The 10 drugs, whose discounts range from 38 to 79 percent of their 2023 list prices, are used to treat a variety of prevalent medical conditions including diabetes, heart disease, and cancer. CMS estimates that in 2026, the negotiated prices will save Medicare $6 billion and reduce Part D beneficiary out-of-pocket (OOP) costs by $1.5 billion. The Assistant Secretary for Planning and Evaluation (ASPE) also released a report entitled, Medicare Drug Price Negotiation Program: Medicare Prices Negotiated for 2026 Compared to List and U.S. Market Prices, which analyzes how the negotiated prices compare to their historical list prices. The report finds that nine of the 10 drugs saw list price increases from 2018 to 2023, with increases ranging from 20 percent to 55 percent. Additionally, the report notes that in 2023, the 10 drugs were utilized by 9 million Medicare beneficiaries and accounted for $56.2 billion in gross Part D spending. As required by the IRA, CMS will select 15 additional drugs to negotiate for 2027 and 2028, and 20 additional drugs to negotiate for subsequent years after. Furthermore, negotiations will begin for Medicare Part B drugs in 2028. ASPR’s report is available here. A fact sheet is available here. A press release is available here.
• On August 13, 2024, the Advanced Research Projects Agency for Health (ARPA-H) announced $150 million in funding for eight research centers to improve the precision and accuracy of cancerous tumor removals. The awards range from $15.1 to $32.6 million and will be used to fund research activities focused on technologies that: (1) improve imaging systems to better visualize excised tumors and cancerous cells, (2) identify any cancerous remnants remaining in the patient, and (3) improve anatomical visibility for surgeons. ARPHA-H notes that these technologies could substantially reduce repeat surgeries rates and unintentional injuries to other bodily structures, such as nerves or blood vessels. The funding is part of President Biden’s Cancer Moonshot initiative, which aims to reduce the cancer death rates by at least half by 2047. A fact sheet is available here. A press release is available here.

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