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 issued the calendar year (CY) proposed 2025 Medicare Physician Fee Schedule (PFS) and Hospital Outpatient Prospective Payment System (OPPS) rules.

I. Regulations, Notices & Guidance

• On July 1, 2024, the Agency for Healthcare Research and Quality (AHRQ) released a notice entitled, Supplemental Evidence and Data Request on Mindfulness-Based Interventions for Mental Health and Wellbeing in Children and Adolescents: A Systematic Review. AHRQ is seeking scientific information submissions from the public. Scientific information is being solicited to inform the agency’s review on Mindfulness-Based Interventions for Mental Health and Wellbeing in Children and Adolescents: A Systematic Review, which is currently being conducted by AHRQ’s Evidence-based Practice Centers (EPC) Program. Access to published and unpublished pertinent scientific information will improve the quality of this review.
• On July 1, 2024, the Administration for Children and Families (ACF) released a notice entitled, Announcement of the Intent to Award a Supplement to the three recipients of the Preferred Communities (PC) program - Church World Service (CWS), US Committee for Refugees and Immigrants (USCRI), and HIAS. The Office of Refugee Resettlement (ORR) announced the intent to award a supplement up to the amount of $ 5,500,000 to be distributed among the three recipients of the Preferred Communities (PC) program that are implementing the Ms. L. Settlement Agreement to provide housing. The three recipients are Church World Service (CWS), US Committee for Refugees and Immigrants (USCRI), and the Hebrew Immigrant Aid Society (HIAS). The supplement is for the provision of housing assistance as specified by the settlement agreement for Ms. L., et al. vs U.S. Immigration and Customs Enforcement et al. These three recipients have already begun implementing the services, and additional supplemental funding will assist in the ability to serve the number of clients estimated to seek services within the proposed period of performance.
• On July 2, 2024, the Department of Health and Human Services (HHS) released a notice entitled, The Interagency Coordination Committee on the Prevention of Underage Drinking Requests for Public Comments. The Interagency Coordinating Committee on the Prevention of Underage Drinking requests public comments on the Alcohol Intake and Health methodology developed for performing a series of studies assessing the relationship between alcohol intake and related health conditions. The Alcohol Intake and Health studies will be completed by experts with experience conducting meta-analyses, relative risk estimates, and systematic reviews related to alcohol intake and health. The studies will assess the current, best, and most applicable scientific evidence on the relationship between consumption of alcohol and health outcomes.
• On July 3, 2024, the Centers for Disease Control and Prevention (CDC) released a notice entitled, Extension of the Application Deadline: The REACH Lark Galloway-Gilliam Award for Advancing Health Equity Challenge (REACH Lark Award Challenge). On April 25, 2024, CDC published a notice announcing the 2024 Racial and Ethnic Approaches to Community Health (REACH) Lark Galloway-Gilliam for Advancing Health Equity Award Challenge (REACH Lark Award Challenge). CDC established a deadline date of June 21, 2024, for the transmittal of applications. This notice extends the deadline date for applications through July 12, 2024.
• On July 3, 2024, the Food and Drug Administration (FDA) released a notice entitled, Notice: Authorization of Emergency Use of an In Vitro Diagnostic Device in Response to an Outbreak of Mpox; Availability. FDA announced the issuance of an Emergency Use Authorization (EUA) under the Federal Food, Drug, and Cosmetic Act (FD&C Act) in response to an outbreak of Mpox. FDA has issued an authorization for an in vitro diagnostic device, Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set as requested by CDC. The authorization follows the August 9, 2022, determination by the Secretary of HHS that there is a public health emergency, or a significant potential for a public health emergency, that affects, or has a significant potential to affect, national security or the health and security of U.S. citizens living abroad, and that involves monkeypox virus. On the basis of such determination, the Secretary of HHS declared, on September 7, 2022, that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of infection with the monkeypox virus, including in vitro diagnostics that detect and/or diagnose infection with non-variola Orthopoxvirus, pursuant to the FD&C Act, subject to terms of any authorization issued under that section.
• On July 8, 2024, FDA released a notice entitled, M14 General Principles on Plan, Design, and Analysis of Pharmacoepidemiological Studies That Utilize Real-World Data for Safety Assessment of Medicines; International Council for Harmonisation; Draft Guidance for Industry; Availability. This draft guidance was prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The draft guidance outlines general principles on planning, designing, and analyzing observational (noninterventional) pharmacoepidemiological studies that utilize fit-for-purpose data for safety assessment of medicines (drugs, vaccines, and other biological products). The draft guidance includes recommendations and high-level best practices for the conduct of these studies. The draft guidance is intended to streamline the development and regulatory assessment of postmarketing pharmacoepidemiological safety studies that include Real-World Data. This guidance also seeks to improve the ability of the study protocol and/or results to be accepted across health authorities and support decision making in response to study results.
• On July 8, 2023, FDA released a notice entitled, Addressing Misinformation About Medical Devices and Prescription Drugs: Questions and Answers; Draft Guidance for Industry; Availability; Agency Information Collection Activities; Proposed Collection; Comment Request. This revised draft guidance, when finalized, will describe FDA’s current thinking on common questions firms may have when voluntarily addressing misinformation about or related to their approved/cleared medical products. This guidance revises and replaces the draft guidance for industry entitled Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices issued in June 2014. This revised draft guidance is not final nor is it in effect at this time.
• On July 8, 2024, FDA released a notice entitled, Purpose and Content of Use-Related Risk Analyses for Drugs, Biological Products and Combination Products; Draft Guidance for Industry and Food and Drug Administration Staff; Availability. This document provides guidance to industry and FDA staff on the purpose and content of a use related risk analysis (URRA) and how a URRA, along with other information, can be used to determine human factors (HF) data needs during product development and to support a marketing application.
• On July 8, 2024, FDA released a notice entitled, Request for Applications for New Members of the Clinical Trials Transformation Initiative/Food and Drug Administration Patient Engagement Collaborative. FDA, in collaboration with the Clinical Trials Transformation Initiative (CTTI), is requesting applications from patient advocates interested in participating on the Patient Engagement Collaborative (PEC). The PEC is an ongoing, collaborative forum coordinated through FDA’s Patient Affairs Staff, Office of Clinical Policy and Programs (OCPP), Office of the Commissioner at FDA, and is hosted by CTTI. Through the PEC, the patient community and FDA staff can discuss an array of topics related to increasing meaningful patient engagement with diverse populations in medical product development and regulatory discussions at FDA.
• On July 8, 2024, the Indian Health Service (IHS) released a notice entitled, Funding Opportunity for Ending the HIV/HCV/Syphilis Epidemics in Indian Country II (ETHIC II): A Syndemic Elimination Program for American Indian/Alaska Native Tribes and Urban Indian Communities. IHS is accepting applications for the second round of cooperative agreement for the Ending the Human Immunodeficiency Virus (HIV), Hepatitis C Virus (HCV), and Syphilis Epidemics (known as “the Syndemic”) in Indian Country (ETHIC II) program. This program is authorized under the Snyder Act, 25 U.S.C. 13; the Transfer Act, 42 U.S.C. 2001(a); and the Indian Health Care Improvement Act, 25 U.S.C. 1621q, 1660e.
• On July 9, 2024, CDC released a notice entitled, Reorganization of the Office of Financial Resources. CDC has modified its structure. This notice announces the reorganization of the Office of Financial Resources (OFR) and the CDC Immediate Office of the Director (IOD). OFR added a branch and a new office was established within the CDC IOD.
• On July 9, 2024, CDC released a notice entitled, Reorganization of the Office of the Chief of Staff. CDC has modified its structure. This notice announces the reorganization of the Office of the Chief of Staff (OCS). OCS has retitled components and updated mission and function statements.
• On July 9, 2024, FDA released a notice entitled, Advisory Committee; Allergenic Products Advisory Committee; Termination; Removal from List of Standing Committees. FDA announced the termination of the Allergenic Products Advisory Committee, Center for Biologics Evaluation and Research. This document announces the reasons for termination and removes the Allergenic Products Advisory Committee from FDA’s list of standing advisory committees.
• On July 10, 2024, the Centers for Medicare & Medicaid Services (CMS) released a proposed rule entitled, Medicare and Medicaid Programs: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems; Quality Reporting Programs, including the Hospital Inpatient Quality Reporting Program; Health and Safety Standards for Obstetrical Services in Hospitals and Critical Access Hospitals; Prior Authorization; Requests for Information; Medicaid and CHIP Continuous Eligibility; Medicaid Clinic Services Four Walls Exceptions; Individuals Currently or Formerly in Custody of Penal Authorities; Revision to Medicare Special Enrollment Period for Formerly Incarcerated Individuals; and All-Inclusive Rate Add-On Payment for High-Cost Drugs Provided by Indian Health Service and Tribal Facilities. This proposed rule would revise the Medicare hospital Outpatient Prospective Payment System (OPPS) and the Medicare Ambulatory Surgical Center (ASC) payment system for calendar year 2025 based on CMS’ continuing experience with these systems.
• On July 10, 2024, FDA released a notice entitled, Clinical Considerations for Studies of Devices Intended To Treat Opioid Use Disorder; Guidance for Industry and Food and Drug Administration Staff; Availability. To help spur innovative options to combat the opioid overdose crisis and treat opioid use disorder (OUD), this guidance provides recommendations on the design of pivotal clinical studies for devices intended to treat OUD (OUD device studies). Through these recommendations, FDA intends to aid sponsors in developing OUD device studies that provide scientific evidence used to determine whether there is a reasonable assurance of safety and effectiveness for treating OUD.
• On July 10, 2024, CMS released a proposed rule entitled, Medicare and Medicaid Programs; CY 2025 Payment Policies under the Physician Fee Schedule and Other Changes to Part B Payment and Coverage Policies; Medicare Shared Savings Program Requirements; Medicare Prescription Drug Inflation Rebate Program; and Medicare Overpayments. This proposed rule addresses: changes to the physician fee schedule (PFS); other changes to Medicare Part B payment policies to ensure that payment systems are updated to reflect changes in medical practice, relative value of services, and changes in the statute; codification of, and proposing policies for, the Medicare Prescription Drug Inflation Rebate Program under the Inflation Reduction Act of 2022; updates to the Medicare Diabetes Prevention Program expanded model; payment for dental services inextricably linked to specific covered medical services; updates to drugs and biological products paid under Part B including immunosuppressive drugs and clotting factors; Medicare Shared Savings Program (MSSP) requirements; updates to the Quality Payment Program (QPP); Medicare coverage of opioid use disorder services furnished by opioid treatment programs; updates to policies for Rural Health Clinics (RHCs) and Federally Qualified Health Centers (FQHCs); electronic prescribing for controlled substances for a covered Part D drug under a prescription drug plan or a Medicare Advantage Prescription Drug (MA-PD) plan under the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (SUPPORT Act); update to the Ambulance Fee Schedule regulations; codification of the Inflation Reduction Act and Consolidated Appropriations Act, 2023 provisions; updates to Clinical Laboratory Fee Schedule regulations; updates to the diabetes payment structure and public health emergency (PHE) flexibilities; expansion of colorectal cancer screening and Hepatitis B vaccine coverage and payment; establishing payment for drugs covered as additional preventive services; Medicare Parts A and B Overpayment Provisions of the Affordable Care Act.
• On July 11, 2024, FDA released a notice entitled, Dental Composite Resin Devices and Dental Curing Lights--Premarket Notification (510(k)) Submissions Guidances; Draft Guidances for Industry and Food and Drug Administration Staff; Availability. These draft guidance documents provide recommendations for device description, performance testing, and labeling to include in 510(k) submissions for dental composite resin devices and dental curing lights. When final, these guidances will supersede the guidances Dental Composite Resin Devices--Premarket Notification [510(k)] Submissions dated October 26, 2005 and Dental Curing Lights--Premarket Notification [510(k)] Submissions dated March 27, 2006. The recommendations in these draft guidances are intended to promote consistency and facilitate efficient review of these submissions. These draft guidances are not final nor are they for implementation at this time.
• On July 12, 2024, HHS released a notice entitled, Increase Flexibility for Tribes in Child Care and Development Fund (CCDF) Eligibility. HHS, through ACF, is proposing to amend the Child Care and Development Fund (CCDF) regulations through this notice of proposed rulemaking (NPRM) to allow all Indian Tribes and Tribal Organizations operating CCDF programs, at their discretion, to establish and use eligibility criteria regardless of family income.
• On July 12, 2024, FDA released a notice entitled, Cellular and Gene Therapies Interactive Site Tours Program for Regulatory Project Managers and Reviewers; Information Available to Industry. The FDA Center for Biologics Evaluation and Research (CBER), Office of Therapeutic Products (OTP) is announcing the Cellular and Gene Therapies Interactive Site Tours Program (the Interactive Site Tours Program). This program is intended to give CBER regulatory project managers and/or reviewers an opportunity to tour biotechnology manufacturing facilities developing cellular and gene therapy products, and to exchange regulatory experiences with their industry counterparts. With this program, CBER intends to enhance review efficiency and quality by providing CBER staff with a better understanding of the biotechnology manufacturing industry and its operations. The purpose of this notice is to invite companies developing cellular and gene therapy products interested in participating in this program to contact OTP for more information.

Event Notices

July 11-12, 2024: FDA announced a meeting entitled, Evaluating Immunosuppressive Effects of In Utero Exposure to Drug and Biologic Products. This is a hybrid meeting open to the public.

July 25, 2024: FDA announced a meeting of the Oncologic Drugs Advisory Committee. This meeting is open to the public.

August 2, 2024: FDA announced a meeting of the Genetic Metabolic Diseases Advisory Committee. This is a virtual meeting open to the public.

August 6, 2024: FDA announced a workshop entitled, Artificial Intelligence (AI) in Drug & Biological Product Development. This is a hybrid workshop open to the public.

August 22, 2024: The Health Resources and Services Administration (HRSA) announced a meeting of the Advisory Council on Blood Stem Cell Transplantation. 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 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: Advisory Committee for Women’s Services (ACWS) and the Tribal Technical Advisory Committee (TTAC). This is a virtual meeting open to the public.

II. Hearings & Markups

• On July 11, 2024, the Senate Committee on Aging held a hearing entitled, Health Care Transparency: Lowering Costs and Empowering Patients. Witnesses included: Dr. Chris Whaley, PhD, Associate Director of the Center for Advancing Health Policy through Research, Associate Professor of Health Services, Policy and Practice, Brown University School of Public Health; Chris Deacon, JD, Principal Owner, VerSan Consulting, LLC; Cora Opsahl, MBA, Health Fund Director, 32BJ Health Fund; and, Sophia Tripoli, MPH, Senior Director of Health Policy, Families USA.

III. Reports, Studies, & Analyses

• On July 2, 2024, the Kaiser Family Foundation (KFF) released an issue brief entitled, In 2024, A Majority of States Offer Medicare Advantage Plans to Their State Retirees, with 13 Offering Medicare Advantage Exclusively. The report found there has been a significant shift towards Medicare Advantage (MA) plans among states offering health benefits to Medicare-age retirees in 2024. Nearly all states and the District of Columbia provide health benefits to their Medicare-age retirees, with only Idaho and Nebraska not offering such benefits. Notably, 13 states now exclusively offer MA plans to their retirees, an increase from eight states in 2016. According to the issue brief, this shift is driven by the potential for cost savings and simplified administration for MA plans. Meanwhile, 21 states and DC offer a combination of MA and supplemental plans that wrap around traditional Medicare, providing retirees with more options. However, the number of states offering only supplemental plans has decreased. This trend reflects the growing preference for MA plans, which typically offer lower premiums and more comprehensive benefits, despite potential tradeoffs such as limited provider networks and the use of utilization management tools.

IV. Other Health Policy News

• On July 1, 2024, the Biden Administration announced the availability of over $200 million to enhance geriatric care, particularly for those with Alzheimer’s disease and related dementias. This funding, managed by HRSA, will support 42 programs across the nation, focusing on training primary care providers to deliver age-friendly and dementia-friendly care. Additionally, the initiative aims to equip families and caregivers with the necessary skills to support their aging loved ones effectively. In his statement, HHS Secretary Xavier Becerra emphasized the administration's dedication to building a skilled healthcare workforce to meet the growing needs of older adults. This effort is part of a broader Health Workforce Initiative to improve workforce recruitment, retention, and career advancement, aligning with the National Plan to Address Alzheimer’s Disease. The program aims to ensure that primary care providers can identify and address the unique needs of older patients, providing comprehensive support to over six million Americans living with Alzheimer’s and their caregivers. A press release with more information is available here.
• On July 8, 2024, the Biden Administration announced $27.5 million in funding opportunities to improve women’s behavioral health across the United States, as part of efforts led by SAMHSA. This funding aims to expand access to mental health and substance use services and enhance provider capacities to address these issues, particularly for pregnant and postpartum women. As part of this initiative, nearly $1 million has been awarded to support residential treatment services for this demographic. These investments, funded through the American Rescue Plan (ARP), will support programs like the Community-Based Maternal Behavioral Health Services Program and the Women’s Behavioral Health Technical Assistance Center. These initiatives aim to provide timely, culturally relevant care and strengthen community referral pathways for at-risk women, as well as enhance the capacity of providers to implement evidence-based practices. A press release with more information is available here.
• On July 10, 2024, CMS released the CY2025 PFS Proposed Rule addressing updates and changes to the Medicare program, aimed at improving healthcare efficiency, accessibility, and quality. In the rule, CMS proposes changes to drug payment policies, notably under the Medicare Prescription Drug Inflation Rebate Program, affecting both Part B and Part D drugs. This includes clarifications on rebate calculations and exclusion criteria for certain drugs, potentially impacting how these medications are priced. The rule also proposes continued reimbursement for telehealth services, via audio-only communication, for any telehealth service furnished to a beneficiary in their home if the distant site physician or practitioner is technically capable of using an interactive telecommunications system but the patient is not capable of, or does not consent to, the use of video technology. Additional key updates involve payment guidelines for dental services linked to specific medical services and changes to the Medicare Shared Savings Program (MSSP) to enhance savings and care coordination. Other provisions include expanded Medicare coverage for opioid use disorder treatments provided by opioid treatment programs, and policy updates for Rural Health Clinics (RHCs) and Federally Qualified Health Centers (FQHCs). The rule also includes revisions to the Ambulance Fee Schedule and Clinical Laboratory Fee Schedule regulations and expanded coverage for colorectal cancer screening and Hepatitis B vaccines. Comments to the rule are due by September 9, 2024. The text of the proposed rule is available here. A fact sheet is available here.
• On July 10, 2024, CMS released the CY2025 OPPS Proposed Rule. The 984-page annual proposed rule includes numerous proposals, including to revise the Medicare Hospital Outpatient Prospective Payment System (OPPS) and the Ambulatory Surgical Center (ASC) payment system for CY 2025. CMS also proposes numerous updates including, but not limited to: (1) modification of the “Four Walls” rule to allow, in part, federal reimbursement for services provided outside a behavioral health clinics and services provided by clinics in rural areas; (2) creation of new Conditions of Participation (CoP) for hospitals and critical access hospitals (CAH) that provide obstetrical (OB) services; and (3) separate payment for any diagnostic radiopharmaceutical with a per day cost greater than $630. Comments to the rule are due by September 9, 2024. The text of the rule is available here. A fact sheet is available here.

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