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 Senate Finance Committee advanced the Better Mental Health Care, Lower-Cost Drugs, and Extenders Act to expand mental health care and lower prescription drug costs for seniors, and CMS released the Contract Year 2025 Medicare Advantage (MA) and Part D Proposed Rule. Read more about these actions and other news below.

I. Regulations, Notices & Guidance 

• On November 6, 2023, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule entitled, 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; Health Information Technology Standards and Implementation Specifications. This proposed rule would revise the Medicare Advantage (Part C), Medicare Prescription Drug Benefit (Part D), Medicare cost plan, and Programs of All-Inclusive Care for the Elderly (PACE) regulations to implement changes related to Star Ratings, marketing and communications, agent/broker compensation, health equity, dual eligible special needs plans (DSNPs), utilization management, network adequacy, and other programmatic areas. This proposed rule also includes proposals to codify existing sub-regulatory guidance in the Part C and Part D programs.
• On November 6, 2023, CMS issued a notice entitled, Medicare, Medicaid, and Children's Health Insurance Programs; Provider Enrollment Application Fee Amount for Calendar Year 2024. This notice announced a $709.00 calendar year (CY) 2024 application fee for institutional providers that are initially enrolling in the Medicare or Medicaid program or the Children's Health Insurance Program (CHIP); revalidating their Medicare, Medicaid, or CHIP enrollment; or adding a new Medicare practice location. This fee is required with any enrollment application submitted on or after January 1, 2024, and on or before December 31, 2024.
• On November 7, 2023, FDA issued final guidance entitled, Real-Time Oncology Review. The purpose of this guidance is to provide recommendations to applicants on the process for submission of selected new drug applications (NDAs) and biologics license applications (BLAs) with oncology indications for review under Real Time Oncology Review (RTOR). This guidance finalizes the draft guidance of the same title issued on July 22, 2022.
• On November 8, 2023, CMS issued a correction entitled, Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Policy Changes and Fiscal Year 2024 Rates; Quality Programs and Medicare Promoting Interoperability Program Requirements for Eligible Hospitals and Critical Access Hospitals; Rural Emergency Hospital and Physician-Owned Hospital Requirements; and Provider and Supplier Disclosure of Ownership; and Medicare Disproportionate Share Hospital (DSH) Payments: Counting Certain Days Associated with Section 1115 Demonstrations in the Medicaid Fraction. This document corrects technical errors in the final rule that appeared in the August 28, 2023 Federal Register titled Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Policy Changes and Fiscal Year 2024 Rates; Quality Programs and Medicare Promoting Interoperability Program Requirements for Eligible Hospitals and Critical Access Hospitals; Rural Emergency Hospital and Physician-Owned Hospital Requirements; and Provider and Supplier Disclosure of Ownership; and Medicare Disproportionate Share Hospital (DSH) Payments: Counting Certain Days Associated with Section 1115 Demonstrations in the Medicaid Fraction.
• On November 8, 2023, CMS issued a notice entitled, Application by the Utilization Review Accreditation Commission for Continued Approval of its Home Infusion Therapy Accreditation Program. This notice acknowledges the receipt of an application from the Utilization Review Accreditation Commission (URAC) for continued approval by CMS of URAC’s national accrediting organization program for suppliers providing home infusion therapy (HIT) services and 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 November 8, 2023, FDA issued an amendment entitled, Hematology and Pathology Devices; Classification of the Container System for the Processing and Storage of Red Blood Cell Components Under Reduced Oxygen Conditions. FDA is classifying the container system for the processing and storage of Red Blood Cell components under reduced oxygen conditions 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 classification of the container system for the processing and storage of Red Blood Cell components under reduced oxygen conditions. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients’ access to beneficial innovative devices.
• On November 8, 2023, FDA issued final guidance entitled, Compliance Policy for Cosmetic Product Facility Registration and Cosmetic Product Listing. This guidance announced FDA’s intention to delay enforcement of the requirements related to cosmetic product facility registration and cosmetic product listing for an additional six months after the initial December 29, 2023, deadline.

Event Notices

• November 13 and 14, 2023: The Administration for Strategic Preparedness and Response (ASPR) announced its Biomedical Advanced Research and Development Authority (BARDA) Industry Day 2023. BARDA annually hosts a two-day conference with industry and government partners to share BARDA’s goals and objectives, increase awareness of U.S. government medical countermeasure (MCM) priorities, and facilitate collaboration between public and private sectors within the health security space. This year, BARDA plans to discuss implementation efforts for the 2022-2026 Strategic Plan. This is a hybrid event open to the public.
• November 14, 2023: The Centers for Disease Control and Prevention (CDC) announced a meeting of the Advisory Committee to the CDC Director. This is a hybrid meeting that is open to the public. There will be an opportunity for public comment.
• November 16, 2023: The National Institutes of Health (NIH) announced that the Diabetes Mellitus Interagency Coordinating Committee will hold a public online meeting entitled, The Application of Digital Health Technology to Type 2 Diabetes Management: Current Status, Research Gaps, and Opportunities.
• November 16, 2023: FDA announced a meeting of the Oncologic Drugs Advisory Committee. This is a virtual meeting that will be open to the public and the agency is establishing a docket for public comment.
• November 17, 2023: 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) Implementation Working Group. This is a virtual meeting open to the public.
• November 28, 29, 30, 2023: CMS announced a virtual public meeting entitled, New Revisions to the Healthcare Common Procedure Coding System (HCPCS) to discuss preliminary coding, Medicare benefit category, and payment determinations for new revisions to the HCPCS Level II code set for non-drug and nonbiological products.
• November 29, 2023: NIH announced the National Cancer Institute will hold a meeting of their Frederick National Laboratory Advisory Committee. This is a virtual meeting open to the public.
• November 29, 2023: FDA announced a meeting of the Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee. This is a virtual meeting open to the public.
• November 30, 2023: CDC announced a meeting of the Board of Scientific Counselors, Deputy Director for Infectious Diseases. This is a virtual meeting open to the public.
• November 30, 2023: FDA announced a public workshop entitled, Advancing the Development of Pediatric Therapeutics on Drug Dosing in Pediatric Patients with Renal Impairment. The workshop will discuss the current landscape of drug dosing in pediatric patients with renal impairment, discuss the gaps in knowledge, and consider innovative approaches to improve the current paradigm for dosing in pediatric patients with renal impairment.
• December 4 and 5, 2023: NIH announced a meeting of the Eunice Kennedy Shriver National Institute of Child Health and Human Development. The meeting will be videocast and is open to the public.
• December 5 and 6, 2023: The Health Resources and Services Administration (HRSA) announced a meeting of the Advisory Committee on Infant and Maternal Mortality (ACIMM). This is a hybrid meeting open to the public.
• December 6, 2023: The Substance Use and Mental Health Services Administration (SAMHSA) announced a meeting of the Interdepartmental Substance Use Disorders Coordinating Committee (ISUDCC). The meeting will include reports from the ISUDCC working groups and discussion of the ISUDCC’s recommendations to the Department of Health and Human Services (HHS) on how the federal government can further integrate and coordinate harm reduction approaches and strategies across the continuum of prevention, treatment, and recovery policies, programs, and practices. This is a virtual meeting open to the public.
• December 7, 2023: NIH announced the National Heart, Lung, and Blood Institute will hold a meeting to update their Advisory Board and public stakeholders on research agendas across NIH for fiscal year (FY) 2024. This is a virtual public meeting that requires registration to attend.
• December 8, 2023: NIH announced the Muscular Dystrophy Coordinating Committee will hold a meeting, The meeting will bring together committee members, representing government agencies, patient advocacy groups, other voluntary health organizations, and patients and their families to update one another on progress relevant to the Action Plan for the Muscular Dystrophies and to coordinate activities and discuss gaps and opportunities leading to better understanding of the muscular dystrophies, advances in treatments, and improvements in patients' and their families' lives.
• December 12 and 13, 2023: CDC announced a meeting of the Advisory Council for the Elimination of Tuberculosis (ACET). This is a virtual meeting open to the public.
• December 13 and December 14, 2023: HHS announced it will hold a virtual public town hall meeting to discuss FY 2025 applications for add-on payments for new medical services and technologies under the hospital inpatient prospective payment system (IPPS).
• 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 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.

II. Hearings & Markups

 U.S. Senate

• On November 8, 2023, the Senate Health, Education, Labor, and Pension (HELP) Subcommittee on Primary Health and Retirement Security held a hearing entitled, Avoiding a Cautionary Tale: Policy Considerations for Artificial Intelligence in Health Care. Witnesses present included Dr. Thomas Inglesby, Director, Johns Hopkins Center for Health Security; Dr. Kenneth D. Mandl, Harvard Professor and Director, Computational Health Informatics Program, Boston Children’s Hospital; Ms. Christine Huberty, Supervising Attorney, Greater Wisconsin Agency on Aging Resources; and, Dr. Keith Sale, Vice President and Chief Physician Executive of Ambulatory Services, The University of Kansas Health System.
• On November 8, 2023, the Senate Committee on Finance held a markup entitled, Open Executive Session to consider an original bill entitled the Better Mental Health Care, Lower-Cost Drugs, and Extenders Act. Legislation considered included the Better Mental Health Care, Low-Cost Drugs, and Extenders Act. The bill was advanced with a 26-0 vote.

III. Reports, Studies, & Analyses

• On November 7, 2023, the Government Accountability Office (GAO) released a report entitled, Public Health Preparedness: Building and Maintaining Infrastructure beyond the COVID-19 Pandemic. The report builds upon lessons learned from the COVID-19 pandemic and examines the challenges states and local entities face in maintaining infrastructure to prepare for public health threats. Through interviews with jurisdictional officials and public health stakeholders, the report found that major barriers to strong public health infrastructure include fragmented timing for public health funding, varied levels of jurisdictional funding, and public health workforce challenges. While the report did not offer recommendations, the GAO warned that barriers to strong public health infrastructure, including lack of funding and an insufficient workforce, can impact jurisdictions’ abilities to adequately respond to public health threats.
• On November 8, the Journal of American Medical Association (JAMA) Health Forum released the following study entitled, Transparency in Coverage Data and Variation in Prices for Common Health Care Services. The analysis examined Humana’s Transparency in Coverage (TIC) pricing data for seven commonly used services to provide transparency and identify differences across the country in negotiated in-network rates. The study revealed that the average county-level rates were typically lowest in Florida and the Central U.S. while rates were highest in the upper-Midwest, Southeast, and California. However, the report highlighted that county-level prices varied widely across all states and oftentimes, lower-priced and higher-priced counties bordered each other.
• On November 9, 2023, the Kaiser Family Foundation (KFF) released a report entitled, Navigating the Unwinding of Medicaid Continuous Enrollment: A Look at Enrollee Experiences. KFF conducted five virtual focus groups to learn about their experiences with Medicaid, awareness of the end of the continuous enrollment provision, experiences renewing their coverage since the start of the unwinding, and if they were disenrolled, efforts to regain Medicaid or transition to other coverage. Findings showed that the renewal process can be easy and seamless for some individuals, but for others the process may be complicated and result in confusion and termination of coverage. As unwinding continues, these enrollee experiences can help inform policy makers about opportunities to improve communication and outreach, simplify notices, aid with renewals including through call centers, and help enrollees who were disenrolled regain Medicaid if eligible or transition to other coverage if no longer eligible.

IV. Other Health Policy News

• On November 3, 2023, the Biden-Harris Administration announced steps the administration is taking to improve the health of rural communities and help rural health care providers stay open. The initiative builds on existing legislation to increase access to affordable health coverage, maintain rural hospitals, strengthen the rural health workforce, and facilitate access to necessary care, including telehealth services. By focusing on lowering healthcare costs, expanding coverage, and addressing unique challenges faced by rural populations, the administration aims to improve rural health by implementing the following measures: 1) closing the Medicaid coverage gap; 2) enhancing Medicare programs; 3) increasing funding for rural hospitals; and, 4) bolstering the rural health workforce. Additionally, the press release highlighted existing measures to improve rural residents’ access to high-speed internet and telehealth services and address behavioral health needs, substance-use disorders, and maternal health needs in these communities. The administration’s efforts include financial support, policy changes, and collaborative initiatives across agencies to ensure accessible, quality healthcare in rural communities. A press release with more information is available here.
• On November 7, 2023, Dr. Monica Bertagnolli was confirmed by the Senate as the director of the NIH in a 62-36 vote. Her confirmation received bipartisan support, however 34 Republicans and two Democrats—including Senate HELP Committee Chair Bernie Sanders (I-VT) voted against her. While Dr. Bertagnolli was nominated for the role in May 2023, her nomination was stalled by Senator Sanders, who believes that NIH should be taking more aggressive action to lower drug costs. The Senate HELP committee held a hearing on Bertagnolli’s nomination on October 18, 2023, and voted to advance her nomination a week later. Dr. Bertagnolli is the first permanent NIH director in nearly two years.
• On November 7, 2023, HHS released an issue brief entitled, HHS Is Taking Action to Strengthen Primary Care detailing agency actions to expand primary care access, reduce health disparities, and improve health outcomes. The brief highlighted actions to promote primary care across reimbursement, workforce, and access through changes to the Medicare Physician Fee Schedule (PFS) for 2023 and 2024, scholarships and loan repayments awards through the National Health Service Corps, and expansions in training and telecommunication access for primary care providers treating mental health conditions. Additionally, HHS highlighted new models from the Centers for Medicare & Medication Innovation (CMMI) such as the Making Care Primary (MCP) Model and the States Advancing All-Payer Health Equity Approaches and Development (AHEAD) Model that increase investments in primary care and test new payment models. The brief outlined future steps to continue strengthening the primary care workforce, expanding health information technology (IT), and improving access to high quality, coordinated care. The issue brief is available here. A press release with more information is available here.
• On November 8, 2023, Republicans on the House Energy and Commerce Committee including Chair Cathy McMorris Rodgers (R-WA-5) and Subcommittee on Health Chair Brett Guthrie (R-KY-2) wrote a letter to the Assistant Secretary and Administrator for SAMHSA Dr. Delphin-Rittmon, requesting details on the use of over $9 billion in Covid-19 relief funds. The Chairs requested the following documents by November 27, 2023:
  • The most recent copies of each state’s Payment Management System and Federal Financial Report draw-down reports for COVID supplemental funding.
  • The most recent copies of Payment Management System and Federal Financial Report draw-down reports for each of the following programs that received COVID-19 supplemental funds: Certified Community Behavioral Health Clinics (CCBHCs); Suicide Prevention Programs; Project AWARE; Tribal Behavioral Health Grants; Substance Use Prevention, Treatment, & Recovery Services Block Grant; Community Mental Health Services Block Grant; National Childhood Traumatic Stress Network; and Community Based Substance Use Disorder Services
  • The most recent copies of each state’s Payment Management System and Federal Financial Report draw-down reports for 9-8-8 crisis care funding.

• The letter is available here.

• On November 8, 2023, CMS released a No Surprises Act (NSA) toolkit to help assisters and advocates who work with consumers faced with surprise medical bills. The toolkit contains the following resources: 1)  introductory language about the NSA; 2) documents that describe the key protections, how the protections apply to various consumers, and the status of implementation; 3) decision trees to help assess consumers’ situations regarding the various provisions of the NSA; 4) an overview of and common questions about how state laws and the NSA interact; and, 5) reference materials, including a glossary and legal citations chart. Altogether, the toolkit contains more than 20 individual resources and a PDF compilation of all the resources. The toolkit is available here.
• On November 9, 2023, Republicans on the House Ways and Means Committee, led by Chairman Jason Smith (R-MO-8), wrote a letter to HHS Secretary Xavier Becerra, Treasury Secretary Janet Yellen, and Acting Labor Secretary Julie Su calling on the Biden Administration to end surprise medical billing as indicated in the NSA. The letter follows a September hearing examining the fallout from the implementation of surprise medical billing protections and an October roundtable with Biden Administration officials highlighting the problems with the Administration’s implementation of the NSA. According to the letter, the Administration’s implementation of the law has led to fewer medical providers covered by health insurance plans, which has led to remaining in-network providers accepting a lower reimbursement rate, putting access to quality patient care in jeopardy. The letter is available here.

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