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, HRSA released its list of designated mental, primary, medical, and dental health professional shortage areas (HPSAs) and President Biden gave HHS greater authority to address drug shortages under the Defense Production Act (DPA).
I. Regulations, Notices & Guidance
- On January 29, 2024, the Centers for Medicare & Medicaid Services (CMS) issued a notice entitled, Medicare and Medicaid Programs; Quarterly Listing of Program Issuances— October through December 2023. This quarterly notice lists CMS manual instructions, substantive and interpretive regulations, and other Federal Register notices that were published in the 3-month period, relating to the Medicare and Medicaid programs and other programs administered by CMS.
- On January 29, 2024, the Food and Drug Administration (FDA) issued a notice entitled, Guidance: Collection of Race and Ethnicity Data in Clinical Trials and Clinical Studies for Food and Drug Administration-Regulated Medical Products. The purpose of this guidance is to provide FDA’s expectations for, and recommendations on, use of a standardized approach for collecting and reporting race and ethnicity data in submissions including information collected and reported from clinical studies and clinical trials for FDA-regulated medical products. Using standard terminology for race and ethnicity helps ensure that data are collected and reported consistently in submissions to FDA. This draft guidance revises the final guidance for industry and FDA staff entitled Collection of Race and Ethnicity Data in Clinical Trials issued on October 26, 2016.
- On January 29, 2024, FDA issued a notification of availability entitled, Human Gene Therapy Products Incorporating Human Genome Editing; Guidance for Industry; Availability. FDA is announcing the availability of a final guidance entitled Human Gene Therapy Products Incorporating Human Genome Editing; Guidance for Industry. The guidance document provides recommendations to sponsors developing human gene therapy products incorporating genome editing (GE) of human somatic cells. Specifically, the guidance provides recommendations regarding information that should be provided in an investigational new drug (IND) application to assess the safety and quality of the investigational GE product, including information on product design, product manufacturing and testing, nonclinical safety assessment, and clinical trial design. The guidance announced in this notice finalizes the draft guidance of the same title dated March 2022.
- On January 29, 2024, FDA issued a notification of availability entitled, Considerations for the Development of Chimeric Antigen Receptor T Cell Products; Guidance for Industry; Availability. FDA is announcing the availability of a final guidance entitled Considerations for the Development of Chimeric Antigen Receptor (CAR) T Cell Products; Guidance for Industry. The guidance is intended to assist sponsors, including industry and academic sponsors, developing ex vivo-manufactured CAR T cell products. The guidance provides CAR T cell specific recommendations regarding chemistry, manufacturing, and control (CMC), pharmacology and toxicology, and design of clinical studies for oncology indications (including hematologic malignancies and solid tumors). The guidance announced in this notice finalizes the draft guidance of the same title dated March 2022.
- On January 29, 2024, the Department of Health and Human Services (HHS) issued a notice entitled, Notice of Interest Rate on Overdue Debts. Section 30.18 of HHS’ claims collection regulations (45 CFR part 30) provides that the HHS Secretary shall charge an annual rate of interest, which is determined and fixed by the Secretary of the Treasury after considering private consumer rates of interest on the date that HHS becomes entitled to recovery. The rate cannot be lower than the Department of Treasury’s current value of funds rate or the applicable rate determined from the Schedule of Certified Interest Rates with Range of Maturities unless the Secretary waives interest in whole or part, or a different rate is prescribed by statute, contract, or repayment agreement. The Secretary of the Treasury may revise this rate quarterly. HHS publishes this rate in the Federal Register. The current rate of 12 3/8 percent, as fixed by the Secretary of the Treasury, is certified for the quarter ended December 31, 2023. This rate is based on the Interest Rates for Specific Legislation, National Health Services Corps Scholarship Program (42 U.S.C. 254o(b)(1)(A)) and National Research Service Award Program (42 U.S.C. 288(c)(4)(B)). This interest rate will be applied to overdue debt until HHS publishes a revision.
- On January 30, 2024, CMS issued a correction for a final rule entitled, Medicare Program; Calendar Year (CY) 2024 Home Health (HH) Prospective Payment System Rate Update; HH Quality Reporting Program Requirements; HH Value-Based Purchasing Expanded Model Requirements; Home Intravenous Immune Globulin Items and Services; Hospice Informal Dispute Resolution and Special Focus Program Requirements, Certain Requirements for Durable Medical Equipment Prosthetics and Orthotics Supplies; and Provider and Supplier Enrollment Requirements; Correction. This document corrects technical errors in the final rule that appeared in the Federal Register on November 13, 2023.
- On January 30, 2024, FDA issued a correction for a notice entitled, Development of Monoclonal Antibody Products Targeting SARS-CoV-2 for Emergency Use Authorization; Guidance for Industry; Correction. FDA is correcting a notice that appeared in the Federal Register on December 21, 2023. The document announced the availability of a final guidance for industry entitled “Development of Monoclonal Antibody Products Targeting SARS-CoV-2 for Emergency Use Authorization.” The document was published with an incorrect docket number. This document corrects that error.
- On January 30, 2024, FDA issued a notification of availability entitled, Hazard Analysis and Risk-Based Preventive Controls for Human Food; Draft Guidance for Industry; Availability. FDA is announcing the availability of a revised draft Introduction, and a revised draft Appendix 1, within a multichapter guidance for industry entitled, Hazard Analysis and Risk-Based Preventive Controls for Human Food. This multichapter draft guidance, when finalized, will explain FDA’s current thinking on how to comply with the requirements for hazard analysis and risk-based preventive controls under its rule entitled, Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food. We revised the draft Introduction and draft Appendix 1: Known or Reasonably Foreseeable Hazards (“Potential Hazards”) to address comments submitted on drafts that we made available in 2016. This draft guidance is not final nor is it in effect at this time.
- On January 31, 2024, FDA issued a final rule entitled, Medical Devices; Quality System Regulation Amendments. FDA is issuing a final rule to amend the device current good manufacturing practice (CGMP) requirements of the Quality System (QS) regulation to harmonize and modernize the regulation. FDA is harmonizing to align more closely with the international consensus standard for devices by converging with the quality management system (QMS) requirements used by other regulatory authorities from other jurisdictions (i.e., other countries). FDA is doing so by incorporating by reference an international standard specific for device quality management systems. Through this rulemaking FDA is also establishing additional requirements and making conforming edits to clarify the device CGMP requirements for such products. This action will continue FDA’s efforts to align its regulatory framework with that used by regulatory authorities in other jurisdictions to promote consistency in the regulation of devices and provide timelier introduction of safe, effective, high-quality devices for patients.
- On January 31, 2024, the Substance Abuse and Mental Health Services Administration (SAMHSA) issued a notice entitled, Current List of HHS-Certified Laboratories and Instrumented Initial Testing Facilities which Meet Minimum Standards to Engage in Urine and Oral Fluid Drug Testing for Federal Agencies. HHS notifies Federal agencies of the laboratories and Instrumented Initial Testing Facilities (IITFs) currently certified to meet the standards of the Mandatory Guidelines for Federal Workplace Drug Testing Programs using Urine or Oral Fluid (Mandatory Guidelines).
- On January 31, 2024, SAMSHA issued a final rule entitled, Medications for the Treatment of Opioid Use Disorder. This final rule modifies and updates certain provisions of regulations related to Opioid Treatment Program (OTP) accreditation, certification, and standards for the treatment of Opioid Use Disorder (OUD) with Medications for Opioid Use Disorder (MOUD) in OTPs. This includes making flexibilities put forth during the COVID-19 Public Health Emergency (PHE) permanent, as well as expanding access to care and evidence-based treatment for OUD. The final rule also removes all language and rules pertaining to the Drug Addiction and Treatment Act (DATA) Waiver from the regulations pursuant to the Consolidated Appropriations Act, 2023.
- On February 2, 2024, the Centers for Disease Control and Prevention (CDC) issued a notice entitled, Lead Exposure and Prevention Advisory Committee (LEPAC); Notice of Charter Renewal. This gives notice under the Federal Advisory Committee Act of October 6, 1972, that the Lead Exposure and Prevention Advisory Committee (LEPAC) has been renewed for a 2- year period through January 17, 2026.
Event Notices
February 6, 2024: FDA announced a meeting of the General Hospital and Personal Use Devices Panel of the Medical Devices Advisory Committee. This meeting is open to the public.
February 13-14, 2024: HHS announced a meeting of the Office of Minority Health. The meeting is open to the public. Individuals who wish to attend must register by emailing OMH-ACMH@hhs.gov by 5:00 p.m. EST on January 30, 2024. Each registrant should provide their name, affiliation, phone number, email address, days attending, and if participation is in-person or via webcast.
February 14, 2024: CDC announced a meeting of the Advisory Board on Radiation and Worker Health, National Institute for Occupational Safety and Health. This meeting is open to the public, but without a public comment period. The public can join the meeting by teleconference.
February 16, 2024: The National Institutes of Health (NIH) announced a meeting of the NIH Clinical Center Research Hospital Board. This is a hybrid meeting open to the public.
February 22, 2024: HHS announced a meeting of the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria. This is a hybrid meeting open to the public.
February 27, 2024: SAMHSA announced a meeting of SAMHSA’s Tribal Technical Advisory Committee (TTAC). This is a hybrid meeting open to the public.
February 27, 2024: SAMHSA announced a meeting of SAMSHA’s Center for Mental Health Services National Advisory Council. This is a hybrid meeting open to the public.
February 28-29, 2024: CDC announced a meeting of the Advisory Committee on Immunization Practices. This is a virtual meeting open to the public.
March 6, 2024: CDC announced a meeting of the Board of Scientific Counselors, National Center for Health Statistics. This meeting is open to the public.
March 13, 2024: NIH announced a meeting of the National Cancer Institute Clinical Trials and Translational Research Advisory Committee. This is a virtual meeting open to the public.
March 13, 2024: CDC announced a meeting of the Board of Scientific Counselors, National Institute for Occupational Safety and Health. This is a virtual meeting open to the public.
March 13, 2024: FDA announced a meeting of the Oncologic Drugs Advisory Committee. This is a virtual meeting open to the public.
March 19, 2024: CDC announced a meeting of the ICD-10 Coordination and Maintenance Committee. This is a virtual meeting open to the public.
March 25-26, 2024: HHS announced a meeting of the Physician-Focused Payment Model Technical Advisory Committee (PTAC). This is a hybrid meeting open to the public.
II. Hearings & Markups
House of Representatives
- On January 31, 2024, the House Committee on Oversight and Accountability held a hearing entitled, Overseeing the Department of Health and Human Services’ Compliance with Congress. The witness was Hon. Melanie Egorin, Assistant Secretary for Legislation, HHS.
- On January 31, 2024, House Energy and Commerce Committee Subcommittee on Health held a hearing entitled, Health Care Spending In The United States: Unsustainable For Patients, Employers, And Taxpayers. Witnesses present included Dr. Chapin White, Ph.D., Director of Health Analysis, Congressional Budget Office; Ms. Sophia Tripoli, MPH, Senior Director of Health Policy, Families USA; Mr. Kevin Lyons, Plan Administrator, New Jersey State Policemen’s Benevolent Association, Inc.; Dr. Benedic Ippolito, Ph.D., M.S., Senior Fellow, American Enterprise Institute, and; Ms. Katie Martin, MPA, President and CEO, Health Care Cost Institute.
III. Reports, Studies, & Analyses
- On January 29, 2024, the Bipartisan Policy Center released a report entitled, Strengthening Regulatory Collaboration Between FDA and CMS. This policy brief outlines practical and bipartisan steps to enhance collaboration between FDA and CMS in the U.S. FDA is responsible for approving drugs for the marketplace based on safety and effectiveness, while CMS determines coverage and payment for these drugs under Medicare and Medicaid. The recommendations aim to improve information sharing between the agencies, fostering collaboration without altering statutory roles or approval processes. The report focused recommendations including providing CMS with timely information from FDA to facilitate independent coding, coverage, and payment decisions without relying on Congress to modify existing statutes. The report stated that the goal of the collaboration is to ensure access to safe and effective therapies promptly while meeting CMS’ statutory requirements.
- On January 30, 2024, the RAND Corporation released a report entitled, Modeling Early Detection and Geographic Variation in Health System Capacity for Alzheimer's Disease–Modifying Therapies. The study employed a simulation model to assess the demand and supply of Alzheimer’s disease (AD) disease-modifying therapies (DMTs) in the U.S, considering primary care practitioners' (PCPs) capacity at the county level. The findings indicated significant variation in health care system capacity to detect, diagnose, and treat early-stage AD with DMTs. The states with the longest wait times are identified, and the study suggests that engaging the primary care workforce in the diagnostic process is crucial to accelerate the delivery of AD DMTs. Primary care and telehealth models were proposed as recommendations to improve access to care, particularly in areas with longer wait times. The study emphasized the need for effective primary care-led models and technological advancements to address capacity disparities and enhance early-stage AD management.
- On January 31, 2024, the Kaiser Family Foundation (KFF) released a report entitled, How Does Use of Medicaid Wraparound Services by Dual-Eligible Individuals Vary by Service, State, and Enrollees’ Demographics? This issue brief analyzes the utilization of Medicaid wraparound services by dual-eligible individuals, offering insights into service types, state-level variations, and demographic patterns among enrollees. Overall, the analysis reveals that 61 percent of dual-eligible individuals, with at least 10 months of full Medicaid coverage, use at least one Medicaid wraparound service. Home- and community-based services (HCBS) and vision services are accessed by around one-fourth of full-benefit dual-eligible individuals, whereas dental care, non-emergency medical transportation (NEMT), and institutional long-term services and supports (LTSS) show lower usage rates. State-level disparities are significant, ranging from 32 percent utilization in Florida to 88 percent in Minnesota, with variations observed across specific services. Demographically, Hispanic dual-eligible individuals exhibit lower usage rates, while those aged 65 and older and females generally demonstrate higher rates for specific services. Policymakers are urged to consider these variations when proposing new Medicare benefits, recognizing Medicaid’s crucial role in providing wraparound services for dual-eligible individuals.
IV. Other Health Policy News
- On January 29, 2024, CMS announced that participation in its accountable care organization (ACO) initiatives increased in 2024. A total of 480 ACOs are participating in the Medicare Shared Savings Program, the largest ACO program in the country. This includes 19 newly formed ACOs participating in a new, permanent payment option that enables them to receive more than $20 million in advance investment payments for caring for underserved populations. Additionally, 245 organizations are continuing their participation in two CMS Innovation Center models: ACO Realizing Equity, Access, and Community Health (ACO REACH) and the Kidney Care Choices (KCC) models. Overall, about 13.7 million people with Traditional Medicare are aligned to an ACO in 2024. ACOs are now serving nearly half of the people with Traditional Medicare, representing a 3 percent increase since 2023. A press release with more information is available here.
- On January 30, 2024, Reps. Michelle Steel (R-CA) and Susie Lee (D-NV) introduced the Equal Access to Specialty Care Everywhere (EASE) Act, a bipartisan initiative addressing specialist shortages and enhancing healthcare access in underserved communities. The proposed legislation seeks to use existing CMS Medicare and Medicaid Innovation (CMMI) funds to establish a virtual specialty network, incorporating telehealth modalities such as clinical decision support and eConsults. By collaborating with primary care providers in underserved areas, including Federally Qualified Health Centers (FQHCs) and Rural Health Clinics (RHCs), the EASE Act aims to reduce wait times, prevent emergency room visits, and improve care coordination for Medicare and Medicaid beneficiaries. The bill responds to the challenge of extended wait times for specialty appointments in underserved and rural regions, offering a telehealth-driven solution to provide timely and cost-effective access to crucial specialty care services. The press release is available here.
- On January 31, 2024, CMS released the Calendar Year (CY) 2025 Advance Notice for the Medicare Advantage (MA) and Medicare Part D Prescription Drug Programs, proposing updates to payment policies. The proposed policies aim to ensure the strength and stability of the MA and Part D programs. If finalized, MA payments from the government to MA plans are expected to increase on average by 3.70 percent, or over $16 billion, from 2024 to 2025. CMS is also detailing improvements to the structure of the Medicare Part D drug benefit for CY 2025, resulting in lower drug costs for millions of Medicare beneficiaries. The proposed updates include an out-of-pocket cost cap at $2,000 for people with Medicare Part D in 2025. The Advance Notice is open for public comment until March 1, 2024. A press release with more information is available here. A fact sheet is available here.
- On February 1, 2024, the Biden Administration announced new actions as part of its Overdose Prevention Strategy, marking two years of efforts to combat overdoses. As part of this effort, SAMHSA released a final rule entitled, Medications for the Treatment of Opioid Use Disorder. This final rule expands access to life-saving medications for opioid use disorder (MOUD) through modifications and updates to certain regulations related to Opioid Treatment Program (OTP) accreditation, certification, and standards for the treatment of Opioid Use Disorder (OUD) with MOUD in OTPs. The effective date of this final rule is April 2, 2024, and the compliance date is April 2, 2026. Additionally, SAMHSA released an updated Overdose Prevention and Response Toolkit to provide guidance on preventing overdoses and responding to opioid or stimulant overdoses for various audiences. A press release with more information is available here. The final rule is available here.
- On February 1, 2024, the Biden Administration has initiated the Medicare Drug Price Negotiation Program to address prescription drug costs. Through the Inflation Reduction Act, Medicare can now directly negotiate prices with drug companies. Initial offers for the first 10 drugs selected are being sent, marking a crucial milestone. HHS released research showing significant price disparities between the U.S. and other developed nations, with U.S. drug prices nearly three times higher. The Inflation Reduction Act also expanded financial protections through the Low-Income Subsidy (LIS) program, eliminating partial benefits. To disseminate information, HHS launched LowerDrugCosts.gov, a resource hub providing plain language materials. A press release with more information is available here.
- On February 2, 2024, a Senate bipartisan 340B working group released the Supporting Underserved and Strengthening Transparency, Accountability, and Integrity Now and for the Future of 340B Act or the SUSTAIN 340B Act, a legislative discussion draft aimed at reforming the heavily scrutinized 340B drug discount program. The draft legislation includes numerous transparency requirements including requiring covered entities to report information about their use of 340B discounts and permits HHS to conduct audits of covered entities, contract pharmacies, child sites, and manufacturers. The draft also requires a national third-party clearinghouse to prevent duplicate discounts, establishes a user fee program in which covered entities must pay a fee to participate in the program, and defines the role of contract pharmacies and child sites. The working group seeks stakeholder input on how to define a “patient” and additional ideas to regulate contract pharmacies and child sites. The text of the bill is available here.
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