Health Care Week in Review: CMS Releases Mandatory TEAM Hospital Participants and Issues RFI on Medicare Administrative Contractor (MAC) Consolidation

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 the hospitals that are required to participate the Transforming Episode Accountability Model (TEAM), and issued a RFI on consolidating MAC jurisdictions and extending their contract lengths.

I. Regulations, Notices, & Guidance

• On September 3, 2024, the Food and Drug Administration (FDA) released a notice entitled, Determination That FLAGYL (Metronidazole) Tablets, 250 Milligrams and 500 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness. FDA has determined that Flagyl (metronidazole) tablets, 250 milligrams (mg) and 500 mg, were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to these drug products, and it will allow FDA to continue to approve ANDAs that refer to these products as long as they meet relevant legal and regulatory requirements.
• On September 3, 2024, the Health Resources and Services Administration (HRSA) released a notice entitled, Solicitation of Nominations for Membership to serve on the Advisory Commission on Childhood Vaccines. HRSA is seeking nominations of qualified candidates to consider for appointment as members of the Advisory Commission on Childhood Vaccines (ACCV). ACCV advises the Secretary of the Department of Health and Human Services (HHS) on issues related to the implementation of the National Vaccine Injury Compensation Program (VICP).
• On September 3, 2024, the National Institutes of Health (NIH) released a notice entitled, Government-Owned Inventions; Availability for Licensing. The inventions listed in this notice are owned by a government agency and are available for licensing to achieve expeditious commercialization of results of federally funded research for the benefit of the public health.
• On September 3, 2024, the Administration for Strategic Preparedness and Response (ASPR) released a notice entitled, Statement of Organization, Functions, and Delegations of Authority. This notice announces revisions to the organizations within ASPR.
• On September 4, 2024, FDA released a notice entitled, Medical Devices; Cardiovascular Devices; Classification of the Adjunctive Open Loop Fluid Therapy Recommender. FDA is classifying the adjunctive open loop fluid therapy recommender into class II. The special controls that apply to the device type are identified in this order and will be part of the codified language for the adjunctive open loop fluid therapy recommender’s classification. FDA is taking this action because the agency has determined that classifying the device into class II 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 4, 2024, FDA released a notice entitled, Medical Devices; Dental Devices; Classification of the Radiofrequency Toothbrush. FDA is classifying the radiofrequency toothbrush into class II. The special controls that apply to the device type are identified in this order and will be part of the codified language for the radiofrequency toothbrush’s classification. FDA is taking this action because the agency has determined that classifying the device into class II 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 4, 2024, FDA released a notice entitled, Medical Devices; Hematology and Pathology Devices; Classification of the Heparin and Direct Oral Factor Xa Inhibitor Drug Test System. FDA is classifying the heparin and direct oral factor Xa inhibitor drug test system into class II. The special controls that apply to the device type are identified in this order and will be part of the codified language for the heparin and direct oral factor Xa inhibitor drug test system’s classification. FDA is taking this action because the agency has determined that classifying the device into class II 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 4, 2024, FDA released a notice entitled, Medical Devices; Ophthalmic Devices; Classification of the Hydrophilic Re-Coating Solution. FDA is classifying the hydrophilic re-coating solution into class II. The special controls that apply to the device type are identified in this order and will be part of the codified language for the hydrophilic re-coating solution’s classification. FDA is taking this action because the agency has determined that classifying the device into class II 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 4, 2024, FDA released a notice entitled, Control of Nitrosamine Impurities in Human Drugs; Guidance for Industry; Availability. This guidance recommends steps manufacturers of active pharmaceutical ingredients (APIs) and drug products should take to detect and prevent unacceptable levels of nitrosamine impurities in pharmaceutical products. The guidance describes two general structural classes of nitrosamine impurities: small-molecule nitrosamine impurities (i.e., nitrosamine impurities that do not share structural similarity to the API), and nitrosamine drug substance-related impurities (NDSRIs), which share structural similarity to the API and are generally unique to each API. The potential root causes of small-molecule nitrosamine impurities and NDSRI formation, detection of nitrosamine impurities, and recommendations for risk assessments, testing, and implementation of controls and other appropriate strategies to prevent or reduce the presence of small-molecule nitrosamine impurities and NDSRIs are provided. This guidance revises the final guidance of the same name issued on February 24, 2021.
• On September 5, 2024, FDA issued a final rule entitled, Medical Devices; Gastroenterology-Urology Devices; Classification of the Hemodialyzer With Expanded Solute Removal Profile. FDA is classifying the hemodialyzer with expanded solute removal profile into class II. The special controls that apply to the device type are identified in this order and will be part of the codified language for the hemodialyzer with expanded solute removal profile’s classification. FDA is taking this action because FDA has determined that classifying the device into class II 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 5, 2024, FDA issued guidance entitled, Incorporating Voluntary Patient Preference Information over the Total Product Life Cycle; Guidance for Industry, Food and Drug Administration Staff and Other Interested Parties; Availability. FDA is announcing the availability of the draft guidance entitled “Incorporating Voluntary Patient Preference Information over the Total Product Life Cycle.” This draft guidance explains the principal concepts that sponsors and other interested parties should consider when choosing to collect and submit patient preference information (PPI). The knowledge gleaned from the use of PPI could be used across the total product life cycle, including for review in investigational device exemption (IDE) applications, premarket approval (PMA) applications, humanitarian device exemption (HDE) applications, De Novo classification requests, or premarket notifications (510(k)s). This draft guidance also discusses FDA’s inclusion of PPI in its decision summaries and provides recommendations for the inclusion of such information in device labeling for certain devices. This draft guidance is not final nor is it to be used for implementation at this time.
• On September 6, 2024, the Centers for Disease Control and Prevention (CDC) released a notice entitled, Solicitation of Nominations for Appointment to the Board of Scientific Counselors Infectious Diseases. CDC is seeking nominations for membership on the Board of Scientific Counselors (BSC) Infectious Diseases (BSC,ID). The BSC ID consists of up to 17 experts from authorities knowledgeable in the fields relevant to the issues addressed by CDC’s infectious disease national centers (e.g., respiratory diseases, healthcare-associated infections, antimicrobial resistance, foodborne diseases, zoonotic and vector-borne diseases, sexually transmitted diseases, preparedness) and related specialties, including clinical and public health practice (including state and local health departments), laboratory practice, research, diagnostics, microbiology, immunology, molecular biology, bioinformatics, infectious disease modeling and outbreak analytics, health policy/communications, and industry.
• On September 6, 2024, CDC released a notice entitled, Solicitation of Nominations for Appointment to the Board of Scientific Counselors, National Center for Health Statistics. CDC is seeking nominations for membership on the BSC, National Center for Health Statistics (BSC, NCHS). The BSC, NCHS consists of up to 15 experts, including the Chair, in fields associated with the scientific and technical program objectives of the National Center for Health Statistics.
• On September 6, 2024, the Centers for Medicare & Medicaid Services (CMS) issued a final rule correction entitled, Medicare Program; Medicare Prescription Drug Benefit Program; Health Information Technology Standards and Implementation Specifications; Correction. This document corrects typographical and technical errors in the final rule that appeared in the June 17, 2024, Federal Register, entitled, “Medicare Program; Medicare Prescription Drug Benefit Program; Health Information Technology Standards and Implementation Specifications.” The effective date of the final rule was July 17, 2024.
• On September 6, 2024, FDA issued a final rule entitled, Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Blood Collection Device for Cell-free Nucleic Acids. FDA is classifying the blood collection device for cell-free nucleic acids into class II. The special controls that apply to the device type are identified in this order and will be part of the codified language for the blood collection device for cell-free nucleic acids’ classification. FDA is taking this action because the agency has determined that classifying the device into class II 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, in part by reducing regulatory burdens.
• On September 6, 2024, FDA issued a final rule entitled, Medical Devices; Gastroenterology-Urology Devices; Classification of the Endoscopic Pancreatic Debridement Device. FDA is classifying the endoscopic pancreatic debridement device into class II. The special controls that apply to the device type are identified in this order and will be part of the codified language for the endoscopic pancreatic debridement device’s classification. FDA is taking this action because FDA has determined that classifying the device into class II 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 6, 2024, the Substance Abuse and Mental Health Services Administration (SAMHSA) released a notice entitled, Fiscal Year (FY) 2024 Notice of Supplemental Funding Opportunity. This notice is intended to inform the public that SAMHSA is supporting administrative supplements in the scope of the parent award for the 56 eligible grant recipients funded in FY 2024 Projects for Assistance in Transition from Homelessness Grant (PATH), Notice of Funding Opportunity (NOFO) SM-24- F2. Each PATH recipient may receive up to $8,967. These awards have a project end date of September 29, 2025.
• On September 6, 2024, SAMHSA released a notice entitled, FY 2024 Notice of Supplemental Funding Opportunity. This notice is to inform the public that SAMHSA is supporting administrative supplements in scope of the parent award for the 59-eligible Community Mental Health Services Block Grant (MHBG) recipients funded under the Combined Block Grant Application for FYs 2024-2025 (Office of Management and Budget (OMB) Control Number 0930-0168). The distribution of MHBG funds, including funds allocated for technical assistance, must adhere to a statutory formula. The formula considers the population at risk, the cost of providing services, and other relevant factors. To comply with these requirements, technical assistance funds will be distributed to States and territories using this established formula. These awards have a project end date of September 30, 2025.

Event Notices

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: NIH announced a meeting of the National Institute on Drug Abuse. This is a hybrid meeting open to the public.

September 12, 2024: HRSA announced a meeting of the Council on Graduate Medical Education (GME). This is a virtual meeting open to the public.

September 12-13, 2024: HHS announced a meeting of the National Vaccine Advisory Committee. 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.

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 17, 2024: SAMHSA announced a joint meeting of the Tribal Technical Advisory Committee (TTAC) and the Indian Health Service (IHS) National Tribal Advisory Committee on Behavioral Health (NTAC). 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.

September 19-20, 2024: CDC announced a joint meeting of the Subcommittee on Privacy, Confidentiality, and Security and the Subcommittee on Standards, two subcommittees of the National Committee on Vital and Health Statistics. This is a virtual meeting open to the public.

September 20, 2024: FDA announced a meeting of the Vaccines and Related Biological Products Advisory Committee. This is a virtual meeting open to the public.

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: 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.

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.

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 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. Reports, Studies, & Analyses

• On September 3, 2024, the HHS Office of Inspector General (OIG) published a report entitled, Massachusetts Opioid Treatment Program Services Met Many of the Federal and State Requirements. OIG audited Massachusetts' oversight of opioid treatment programs (OTPs) amidst the ongoing opioid crisis. OIG’s audit revealed that while Massachusetts had oversight procedures in place, the state’s procedures were not always sufficient to ensure full compliance with Federal and State requirements. Out of 100 sampled OTP services, 26 failed to meet all requirements, primarily due to inadequate treatment plan reviews. OIG recommended that Massachusetts follow up on unsupported services and strengthen its procedures to prevent future noncompliance. In response, Massachusetts agreed with the recommendations and outlined plans for corrective action, highlighting the importance of robust oversight in addressing the opioid epidemic through effective treatment programs.
• On September 6, 2024, the Kaiser Family Foundation (KFF) released a report entitled, Medicaid Waiver Priorities Under the Trump and Biden-Harris Administrations. The report analyzes the Section 1115 Medicaid demonstration waiver policies under the two administrations. Roughly five key areas of difference were identified between the administrations' approaches: work requirements, premiums and eligibility changes, social determinants of health (SDOH), financing and budget neutrality, and transparency and approval processes. The report finds that there were significant differences in waiver priorities, with the Trump administration emphasizing work requirements and eligibility restrictions, while the Biden-Harris administration focusing on expanding coverage and addressing SDOH. For example, while the Trump administration approved 13 state work requirement waivers, the Biden-Harris administration withdrew all previously approved work requirement waivers. The Biden-Harris administration also generally offered more flexibility for states to address health-related social needs, particularly through a new demonstration opportunity for health-related social needs initiatives.

III. Other Health Policy News

• On September 4, 2024, CMS released a Request for Information (RFI) to solicit public feedback on the potential to consolidate the four Medicare Administrative Contractors (MACs) jurisdictions into two jurisdictions. MACs are private health care insurers that CMS grants specific regional jurisdictions to handle and process Traditional Medicare claims, including those for Part A and B medical services, as well as Durable Medical Equipment (DME). CMS had previously planned to consolidate the MACs into two jurisdictions by 2017 but paused the consolidation in 2014 to build a competitive pool of MACs and promote program stability. The RFI asks for input on extending MAC contracts to 10 years. CMS currently awards MAC contracts for seven years but is considering extending this timeline to 10 years because the agency believes strong program stability has been achieved in recent years. RFI responses are due on October 4, 2024.
• On September 5, 2024, CMS published a list of 741 acute care hospitals (ACHs) that are required to participate in the Transforming Episode Accountability Model (TEAM). TEAM is a mandatory, episodic-based payment model that will bundle ACH payments for five types of surgical episodes. While the model will not be implemented in all states, it will operate in 188 Core-Based Statistical Areas (CBSAs) across the U.S. ACHs located in these CBSAs are required to participant in TEAM. TEAM launches on January 1, 2026, and will run for five years.

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