Health Care Week In Review: CMS and HHS issue proposed rules

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 2024 PFS and OPPS annual payment proposed rules and HHS announced new proposed rules to expand childcare and affirm LGBTQ rights in its programs. Read more about these actions and other news below.

I. Regulations, Notices & Guidance

• On July 11, 2023, the Consumer Financial Protection Bureau (CFPB), the Centers for Medicare & Medicaid Services (CMS), the Department of Health and Human Services (HHS), and the Department of the Treasury (Treasury) issued a request for information (RFI) entitled, Request for Information Regarding Medical Payment Products. The CFPB, an independent agency, HHS, and the Treasury (collectively, the agencies), are soliciting comments from the public and interested parties on medical credit cards, loans, and other financial products used to pay for health care. The agencies seek to understand the prevalence, nature, and impact of these products, including disparities across different demographic groups. The agencies also seek to understand the effects these products may have on patients and on the health care system. In particular, the agencies seek comment on whether these products may allow health care providers to operate outside of a broad range of patient and consumer protections. The agencies also seek comment on whether these products may contribute to health care cost inflation, displace hospitals’ provision of financial assistance, lead patients to pay inaccurate or inflated medical bills, increase the amount patients must pay due to financing costs, or otherwise harm patients’ mental, physical, and financial well-being, including through downstream credit reporting and debt collection practices. In line with the agencies’ work to lower health care costs and reduce the burden of medical debt, the agencies also seek comment on policy options to protect consumers from harm. Comments must be received by September 10, 2023.
• On July 11, 2023, the Food and Drug Administration (FDA) issued revised draft guidance entitled, Inborn Errors of Metabolism That Use Dietary Management: Considerations for Optimizing and Standardizing Diet in Clinical Trials for Drug Product Development. This draft guidance describes FDA’s current recommendations for optimizing and standardizing dietary management in clinical trials for the development of drug products intended to treat inborn errors of metabolism (IEM) when dietary management is a key component of patients’ metabolic control. Optimizing and standardizing dietary management in these patients before they enter clinical trials and during clinical trials is essential to providing an accurate evaluation of the efficacy of new drug products. This guidance revises the draft guidance of the same name issued on July 24, 2018.
• On July 11, 2023, FDA issued a notice entitled, Request for Nominations for Individuals and Consumer Organizations for Advisory Committees. FDA is requesting that any consumer organizations interested in participating in the selection of voting and/or nonvoting consumer representatives to serve on its advisory committees or panels notify FDA in writing. FDA is also requesting nominations for voting and/or nonvoting consumer representatives to serve on advisory committees and/or panels for which vacancies currently exist or are expected to occur in the near future. Nominees recommended to serve as a voting or nonvoting consumer representative may be self-nominated or may be nominated by a consumer organization. FDA seeks to include the views of individuals on its advisory committee regardless of their gender identification, religious affiliation, racial and ethnic identification, or disability status and, therefore, encourages nominations of appropriately qualified candidates from all groups. Nominations must be received by August 26, 2023.
• On July 11, 2023, HHS issued a proposed rule entitled, Health and Human Services Grants Regulation. HHS’ Office for Civil Rights (OCR) and Office of the Assistant Secretary for Financial Resources (ASFR) issued this notice of proposed rulemaking (NPRM) to repromulgate and revise certain regulatory provisions of the HHS, Uniform Administrative Rule Requirements, Cost Principles, and Audit Requirements for HHS Awards. Specifically, this NPRM affirms civil rights and equal opportunity for LGBTQ+ in HHS-funded programs. It clarifies the prohibition of discrimination on the basis of sexual orientation and gender identity in HHS programs, including Head Start, grants, mental health and substance use disorder treatment, community services, etc. The proposed rule also includes a provision that ensures that those with religious objections may seek modifications or exemptions from program requirements. Comment on this proposed rule must be received by September 11, 2023.
• On July 11, 2023, HHS issued a proposed rule entitled, Improving Child Care Access, Affordability, and Stability in the Child Care and Development Fund (CCDF). HHS’ Administration for Children and Families (ACF) proposes to amend the CCDF regulations. This NPRM proposes changes to lower families’ childcare costs, which can be a significant financial strain for families and disincentivize work, training, and education. It proposes changes to improve childcare provider payment rates and practices to increase parent choice for childcare arrangements and help stabilize operations for participating providers. It also proposes ways for CCDF Lead Agencies to streamline eligibility and enrollment processes so families can receive childcare assistance faster and so program bureaucracy is less likely to disrupt parent employment, training, and education and impede access to childcare. The NPRM also includes technical and other changes to improve clarity and program implementation. Comments on this proposed rule must be received by August 27, 2023.
• On July 13, 2023, FDA issued draft guidance entitled, Manufacturing Changes and Comparability for Human Cellular and Gene Therapy Products; Draft Guidance for Industry. The management of manufacturing changes presents many challenges for human cellular therapy or gene therapy (CGT) products due to the complexity of these products. This draft guidance provides sponsors of Investigational New Drug Applications (INDs) and applicants of Biologics License Applications (BLAs) for CGT products, with recommendations regarding product comparability and the management of manufacturing changes for investigational and licensed CGT products. The purpose of this draft guidance is to provide FDA’s current thinking on management and reporting of manufacturing changes for CGT products based on a life-cycle approach, and comparability studies to assess the effect of manufacturing changes on product quality.
• On July 13, 2023, FDA issued draft guidance entitled, Postmarketing Studies and Clinical Trials: Determining Good Cause for Noncompliance with Section 505(o)(3)(E)(ii) of the Federal Food, Drug, and Cosmetic Act. The Federal Food, Drug, and Cosmetic Act (FD&C Act) authorizes FDA to require certain postmarketing studies and clinical trials for prescription drugs at the time of approval or after approval if FDA becomes aware of new safety information. This draft guidance describes the factors FDA considers when determining whether an applicant has demonstrated good cause for failure to comply with the timetable for completion of studies or clinical trials required under the provisions. This draft guidance also provides information on relevant procedures, including how an applicant should communicate with FDA regarding compliance with these required studies and trials and describes actions FDA may take for noncompliance with the requirements.
• On July 13, 2023, FDA issued a request for applications (RFA) entitled, 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 the 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 are able to discuss an array of topics related to increasing meaningful patient engagement with diverse populations in medical product development and regulatory discussions at FDA. The activities of the PEC may include, but are not limited to, providing diverse perspectives on topics such as systematic patient engagement, transparency, and communication; providing considerations for implementing new strategies to enhance patient engagement at FDA; and proposing new models of collaboration in which patient, caregiver, and patient advocate perspectives are incorporated into general medical product development and regulatory processes. Up to 75 applications will be accepted for review between July 14, 2023 and August 13, 2023.
• On July 13, 2023, FDA issued a notice entitled, Request for Nominations from Industry Organizations Interested in Participating in the Selection Process for Nonvoting Industry Representatives and Request for Nominations for Nonvoting Industry Representatives on Public Advisory Committees. FDA is requesting that any industry organizations interested in participating in the selection of nonvoting industry representatives to serve on its public advisory committees for the Center for Drug Evaluation and Research (CDER) notify FDA in writing. FDA is also requesting nominations for nonvoting industry representatives to serve on CDER’s public advisory committees. A nominee may either be self-nominated or nominated by an organization to serve as a nonvoting industry representative. Nominations will be accepted for current vacancies effective with this notice. Any industry organization interested in participating in the selection of an appropriate nonvoting member to represent industry interests must send a letter of interest and nomination materials to FDA by August 13, 2023.
• On July 13, 2023, CMS issued a proposed rule entitled, Medicare and Medicaid Programs: CY 2024 Payment Policies under the Physician Fee Schedule and Other Changes to Part B Payment and Coverage Policies; Medicare Shared Savings Program Requirements; Continued Implementation of Requirements for Manufacturers of Certain Single-dose Container or Single-use Package Drugs to Provide Refunds with Respect to Discarded Amounts; Medicare Advantage; Medicare and Medicaid Provider and Supplier Enrollment Policies; and Basic Health Program. This major 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; payment for dental services inextricably linked to specific covered medical services; Medicare Shared Savings Program requirements; updates to the Quality Payment Program; Medicare coverage of opioid use disorder (OUD) services furnished by opioid treatment programs; updates to certain Medicare and Medicaid provider and supplier enrollment policies, electronic prescribing for controlled substances for a covered Part D drug under a prescription drug plan or a Medicare Advantage Prescription Drug (MAPD)plan under the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (SUPPORT Act); updates to the Ambulance Fee Schedule (AFS) regulations and the Medicare Ground Ambulance Data Collection System (GADCS); codification of the Inflation Reduction Act (IRA) and Consolidated Appropriations Act, 2023 (CAA, 2023) provisions; expansion of diabetes screening and diabetes definitions; pulmonary rehabilitation, cardiac rehabilitation and intensive cardiac rehabilitation expansion of supervising practitioners; appropriate use criteria for advanced diagnostic imaging; early release of MA risk adjustment data; a social determinants of health (SDOH) risk assessment in the annual wellness visit and Basic Health Program.
• On July 13, 2023, CMS issued a proposed rule entitled, Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems; Quality Reporting Programs; Payment for Intensive Outpatient Services in Rural Health Clinics, Federally Qualified Health Centers, and Opioid Treatment Programs; Hospital Price Transparency; Changes to Community Mental Health Centers Conditions of Participation, Proposed Changes to the Inpatient Prospective Payment System Medicare Code Editor; Rural Emergency Hospital Conditions of Participation Technical Correction. 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 (CY) 2024 based on CMS’ continuing experience with these systems. In this proposed rule, CMS describes the changes to the amounts and factors used to determine the payment rates for Medicare services paid under the OPPS and those paid under the ASC payment system. This proposed rule also would update and refine the requirements for the Hospital Outpatient Quality Reporting (OQR) Program, the ASC Quality Reporting (ASCQR) Program, and the Rural Emergency Hospital Quality Reporting (REHQR) Program. This proposed rule would also establish payment for certain intensive outpatient services under Medicare, beginning January 1, 2024. In addition, this proposed rule would update and refine requirements for hospitals to make public their standard charge information and enforcement of hospital price transparency. CMS also proposes to codify provisions of the Consolidated Appropriations Act, 2023, in Community Mental Health Centers Conditions of Participation (CoPs). CMS proposes to revise the personnel qualifications of Mental Health Counselors and add personnel qualifications for Marriage and Family Therapists in the CMHC CoPs. CMS also seeks comment on separate payment under the Inpatient Prospective Payment System (IPPS) for establishing and maintaining access to a buffer stock of essential medicines to foster a more reliable, resilient supply of these medicines. Finally, CMS proposes to address any future revisions to the IPPS Medicare Code Editor (MCE), including any additions or deletions of claims edits, as well as the addition or deletion of ICD-10 diagnosis and procedure codes to the applicable MCE edit code lists, outside of the annual IPPS rulemakings. Additionally, CMS is proposing a technical correction to the Rural Emergency Hospital (REH) CoPs.
• On July 14, 2023, CMS issued an RFI entitled, Request for Information: Episode-based Payment Model. This RFI seeks input from the public regarding the design of a new episode-based payment model that would be designed with a goal to improve beneficiary care and lower Medicare expenditures by reducing fragmentation and increasing care coordination across health care settings. Specifically, CMS requests input on questions related to care delivery and incentive structure alignment and six foundational components: (1) clinical episodes; (2) participants; (3) health equity; (4) quality measures, interoperability, and multi-payer alignment; (5) payment methodology; and (6) model overlap. Responses to this RFI may be used to inform potential future rulemaking or other policy development. Comments on this RFI are due by August 17, 2023.

Event Notices

• August 10-11, 2023: The Health Resources and Services Administration (HRSA) announced a public meeting of the Advisory Committee on Heritable Disorders in Newborns and Children (ACHDNC). At this meeting, ACHDNC will hear from experts in the fields of public health, medicine, heritable disorders, rare disorders, and newborn screening. Agenda items: (1) a presentation on health equity and newborn screening; (2) an update on the Duchenne muscular dystrophy condition nomination and a potential vote on whether to move it forward to full evidence-based review, which, depending on the strength of the evidence, could lead to a future recommendation to add this condition to the Recommended Uniform Screening Panel (RUSP); (3) a presentation, discussion, and vote on an ACHDNC expedited review process for resubmitted condition nomination packages; and (4) a potential presentation and vote on whether to consider Krabbe disease through the ACHDNC expedited review process described above.
• August 21-22, 2023: HHS announced a virtual meeting of the Advisory Panel on Hospital Outpatient Payment (the Panel). The purpose of the Panel is to advise the Secretary of HHS and the Administrator of CMS concerning the clinical integrity of the Ambulatory Payment Classification (APC) groups and their associated weights, which are major elements of the OPPS and the ASC payment system; and supervision of hospital outpatient therapeutic services. At this meeting, the panel will discuss: (1) addressing whether procedures within an APC group are similar both clinically and in terms of resource use, (2) reconfiguring APCs, (3) evaluating APC group weights, (4) reviewing packaging costs of items and services, including drugs and devices, into procedures and services, including the methodology for packaging and the impact of packaging the cost of those items and services on APC group structure and payment; (5) removing procedures from the inpatient only list for payment under the OPPS; (6) using claims and cost report data for CMS’ determination of APC group costs; (7) addressing other technical issues concerning APC group structure; (8) evaluating the required level of supervision for hospital outpatient services; and (9) OPPS APC rates for covered Ambulatory Surgical Center (ASC) procedures.
• August 22, 2023: The Centers for Disease Control and Prevention (CDC) announced a public virtual meeting of the Healthcare Infection Control Practices Advisory Committee (HICPAC). The agenda will include the following updates: The Healthcare Personnel Guideline Workgroup; Isolation Precautions Guideline Workgroup; National Healthcare Safety Network Workgroup; and Dental Unit Waterlines Guideline Update.
• August 28, 2023: HHS announced an online public meeting of the Administration for Strategic Preparedness and Response’s (ASPR) National Biodefense Science Board (NBSB). The NBSB provides expert advice and guidance to HHS regarding current and future chemical, biological, radiological, and nuclear threats, as well as other matters related to disaster preparedness and response.
• August 29, 2023: The Substance Abuse and Mental Health Services Administration (SAMHSA) announced a virtual meeting of the Tribal Technical Advisory Committee (TTAC). This meeting will include, but is not limited to, remarks from the Assistant Secretary for Mental Health and Substance Use; updates on SAMHSA priorities; follow up on topics related to the previous TTAC meetings; and council discussions. Immediately following the TTAC meeting, SAMHSA will host American Indian and Alaska Native (AI/AN) Federally Recognized Tribes for a virtual Tribal Consultation session on the Behavioral Health and Substance Use Disorder Resources for Native Americans Program. TTAC meetings are exclusively between federal officials and elected officials of Tribal governments (or their designated employees) to exchange views, information, or advice related to the management or implementation of SAMHSA programs. The public may attend but are not allowed to participate in the meeting.
• September 11-12,2023: FDA announced a public advisory committee meeting of the Nonprescription Drugs Advisory Committee (the Committee). The Committee will discuss new data regarding the ‘Generally Recognized as Safe and Effective’ (GRASE) status of oral phenylephrine as a nasal decongestant that have become available since FDA last examined the issue.
• September 19-20, 2023: FDA announced a public advisory committee meeting of the Pediatric Advisory Committee (the Committee). The purpose of this public meeting is to discuss the appropriate development plans for establishing safety and effectiveness of artificial womb technology devices, including regulatory and ethical considerations for first in human studies.

II. Hearings & Markups

U.S. House of Representatives

• On July 11, 2023, the House Committee on Oversight and Accountability Select Subcommittee on the Coronavirus Pandemic held a hearing entitled, Investigating the Proximal Origin of a Cover Up. Witnesses present included: Dr. Kristian Andersen, Professor, Scripps Research; and Dr. Robert Garry, Professor, Tulane University School of Medicine.
• On July 12, 2023, the House Committee on Education & the Workforce held a markup entitled, Transparency in Billing Act, Transparency in Coverage Act, Health DATA Act, and Hidden Fee Disclosure Act. The bills considered during this markup included: H.R. 4509, the Transparency in Billing Act; H.R. 4507, the Transparency in Coverage Act; H.R. 4527, the Health DATA Act; and H.R. 4508, the Hidden Fee Disclosure Act.
• On July 13, 2023, the House Committee on the Judiciary held a hearing entitled, Oversight of the Federal Trade Commission. Witnesses present included: the Honorable Lina Khan, Chair, Federal Trade Commission (FTC).
• On July 13, 2023, the House Committee on Energy and Commerce Subcommittee on health held a markup of 17 bills. Legislation considered included: R. 824, the Telehealth Benefit Expansion for Workers Act of 2023; H.R. 3226, the Prematurity Research Expansion and Education for Mothers who deliver Infants Early (PREEMIE) Reauthorization Act of 2023; H.R. 3838, the Preventing Maternal Deaths Reauthorization Act of 2023; H.R. 3843, the Action for Dental Health Act of 2023; H.R. 3884, the Sickle Cell Disease and Other Heritable Blood Disorders Research, Surveillance, Prevention, and Treatment Act of 2023; H.R. 3821, the Firefighter Cancer Registry Reauthorization Act of 2023; H.R. 2365, the National Plan to End Parkinson’s Act; H.R. 3391, the Gabriella Miller Kids First Research Act 2.0; H.R. 4421, the Preparing for All Hazards and Pathogens Reauthorization Act; H.R. 4420, the Preparedness and Response Reauthorization Act; H.R. 4529, the Public Health Guidance Transparency and Accountability Act of 2023; H.R. 4381, the Public Health Emergency Congressional Review Act; H.R. 3813, the CDC Leadership Accountability Act of 2023; H.R. 3836, the Medicaid Primary Care Improvement Act; H.R. 4531, the Support for Patients and Communities Reauthorization Act; H.R. 4056, the Ensuring Medicaid Continuity for Foster Care Act of 2023; and H.R. 3887, the Children’s Hospital GME Support Reauthorization Act of 2023.

U.S. Senate

• On July 11, 2023, the Senate Committee on Appropriations held a hearing entitled, Accelerating Breakthroughs: How the Special Diabetes Program Is Creating Hope for those Living with Type 1 Diabetes. Witnesses present in panel one included: Dr. Griffin P. Rodgers, Director, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institutes of Health (NIH). Witnesses present in panel two included: Dr. Aaron J. Kowalski, Chief Executive Officer (CEO), JDRF; James "Jimmy Jam" Harris, Award-winning Music Producer and Philanthropist; Maria Muayad, JDRF 2023 Children’s Congress Delegate; and Elise Cataldo, JDRF 2023 Children’s Congress Delegate.
• On July 11, 2023, the Senate Committee on Health, Education, Labor, and Pensions (HELP) Subcommittee on Primary Health and Retirement Security held a hearing entitled, Superbugs: The Impact of Antimicrobial Resistance on Modern Medicine. Witnesses present included: Dr. Michael Apley, Professor, College of Veterinary Medicine at Kansas State University; Dr. Helen Boucher, Dean and Professor of Medicine, Tufts University School of Medicine; Melanie Lawrence, Healthcare Advocate; Christine Ann Miller, President & CEO, Melinta Therapeutics.

III. Reports, Studies & Analyses

• On July 10, 2023, Center for Medicare & Medicaid Innovation (CMMI) released a white paper entitled, Assessing Equity to Drive Health Care Improvements: Learnings from the CMS Innovation Center. CMMI prioritized health equity in a 2021 strategy refresh. As such, in this paper, the agency analyzed the degree of and impact of health equity incorporation into 17 model designs and evaluations between January 2018 and June 2022. CMMI identified two groups of models: (1) models designed to address the needs of underserved enrollees, and (2) models that include underserved enrollees but are designed to address the population at large. It found that Group One models reached a higher proportion of racial and ethnic minorities, included the highest proportion of Medicaid enrollees, and all screened for health-related social needs (HRSNs). Additionally, CMMI found that many models encountered data challenges to addressing health equity (e.g., small population size, missing data, etc.) and noted that there are opportunities to improve data (e.g., link data sets to fill information gaps, target sampling in data collection, etc.). It also noted that by incorporating health equity priorities into a model design from the onset (e.g., requiring participating entities to collect key demographic information), it could further improve its understanding of health equity considerations in model designs and evaluations. CMMI concluded that by addressing gaps in assessing health equity through its models, it can better promote equitable quality improvement across the health care system.
• On July 11, 2023, GAO published a report entitled, COVID-19: GAO Recommendations Can Help Federal Agencies Better Prepare for Future Public Health Emergencies. This report summarizes GAO's findings and recommendations from COVID-19 oversight reports issued from April 2022 through April 2023 on the following topics: (1) public health preparedness, (2) improper payments and fraud, (3) vulnerable populations, (4) distribution of federal COVID-19 funding, and (5) COVID-19 and the economy. GAO published this report with key data updates and five enclosures that summarize and highlight previous GAO reports to describe findings and recommendations on the five topic areas previously listed. For example, GAO found that HHS did not adequately lead federal efforts to prepare for and respond to the COVID-19 pandemic, which hindered the U.S.’s capacity to expand access to diagnostic testing and medical countermeasures as well as real-time health information. Additionally, GAO found that improper payments and fraud in federal programs and funding greatly increased during the pandemic. As of April 2023, GAO has issued a total of 386 recommendations to 26 federal agencies and 19 suggestions to Congress to strengthen emergency response and preparedness; about 45 percent of these recommendations have been fully or partially addressed.
• On July 12, 2023, the Kaiser Family Foundation (KFF) published a report entitled, A Small Number of Drugs Account for a Large Share of Medicare Part D Spending. This report aimed to provide context for the new Medicare Drug Price Negotiation Program established by the IRA, which would require the federal government to negotiate the price of certain high-spend Part D drugs, by identifying the 10 top-selling Part D drugs in 2021 and examining changes in spending as a share of total Medicare Part D drug spending and use of these drugs since 2018. KFF authors found that the 10 top-selling drugs accounted for only 0.3 percent of covered drugs but 22 percent of total gross Medicare Part D spending in 2021 ($48 billion). The top-selling drug accounted for nearly one-quarter of the $48 billion itself. Authors also found that aggregate Medicare spending for the 10 top-selling Part D drugs more than doubled between 2018 and 2021. They concluded that Medicare Part D spending is highly concentrated among a small share of covered brand-name drugs and that the 10 top-selling drugs have contributed greatly to the substantial increase in Medicare drug spending overall.
• On July 13, 2023, the United Nations Population Fund published a report entitled, Maternal Health Analysis of Women and Girls of African Descent in the Americas. This report assessed comparative data on maternal health outcomes and experiences of Afrodescendant women in the Americas. It highlights three primary findings: (1) Afrodescendant women are disadvantaged before, during, and after pregnancy in both South and North America, (2) maternal deaths among Afrodescendant women in the Americas occur at “alarmingly high” rates, and (3) structural racism, sexism, and income disparities are evident in and exacerbate maternal health disparities in the Americas. The UN Population Fund also found that the lack of data disaggregated by race and gender as well as national policies that overlook particular health vulnerabilities of the Afrodescendant population contribute to poor access and provision of quality maternal, sexual, and reproductive health care for Afrodescendant women. As such, it recommends that national governments, international organizations, and health care providers take intentional steps to address the root causes of structural racism, sexism, and discrimination to improve the maternal health outcomes and experiences of Afrodescendant women in South and North America.
• On July 13, 2023, GAO published a report entitled, Regenerative Medicine: Therapeutic Applications, Challenges, and Policy Options. GAO assessed current and emerging regenerative medicine technologies and therapeutic applications to understand: (1) potential benefits of current and emerging regenerative medicine technologies, (2) challenges that hinder their development and use, and (3) policy options that could mitigate these challenges. Regenerative medicine can help restore or replace cell, tissue, and organ functions affected by disease, injury, or aging. Examples of regenerative medicines include CAR T cell therapy, in which a patient’s immune cells are altered so they can better fight cancer cells, and genetically edited stem cell therapy, in which a patient’s cells are genetically edited to address their sickle cell disease. GAO identified many challenges that may affect the development and use of regenerative medicine technologies and therapies including: (1) it is difficult to standardize practices, policies, guidelines, even federal regulation for developing these therapies because they are so complex and innovative; and (2) it is difficult to rapidly produce these therapies and scale their production because they are so complex and unique, which also makes it difficult to monitor and ensure quality. To address these challenges, GAO developed 11 policy options to help address these challenges, including: (1) invest in standards development; (2) increase interaction and communication between federal regulators and manufacturers; and (3) create training opportunities at community and technical colleges to address manufacturing workforce shortages.

IV. Other Health Policy News

• On July 13, 2023, CDC announced its plan to launch the Bridge Access Program for COVID-19 Vaccines. In Fall 2023, the U.S. Government COVID-19 Vaccine Distribution Program will end, transitioning these vaccines to the commercial market. In the commercial market, COVID-19 vaccines will still be free for most Americans through their health insurance plans and for children through the Vaccines for Children Program (VCF). However, there are 25-30 million adults (ages 18-64) without insurance and other adults who cannot afford vaccines even with insurance who may lose access to these critical vaccines when the federal program ends. To avoid this lapse in coverage, CDC will purchase and allocate COVID-19 vaccines through the new Bridge Access Program to allow adults who are uninsured or underinsured to receive the vaccines free of charge through December 2024. CDC also announced that it will work closely with pharmacies and manufacturers to ensure there is adequate supply and distribution of COVID-19 vaccines for this program. CDC notes that this is a temporary solution, and that the fiscal year (FY) 2023 and 2024 presidential budgets have proposed establishing a permanent Vaccines for Adults Program (VFA) to cover all recommended vaccines at no cost for uninsured adults. More information on this announcement can be found here.
• On July 13, 2023, HHS and SAMHSA announced the addition of Spanish text and chat services to its 988 Suicide & Crisis Lifeline (988 Lifeline). The Biden Administration launched the 988 Lifeline in July 2022 to address the growing mental health and substance use disorder (SUD) crisis in the U.S. Since last July, the 988 Lifeline network, comprised of more than 200 state and local call centers, answered nearly 5 million calls, texts, and chats from people experiencing mental health crises. Studies demonstrate that people experiencing mental health crises are likely to feel less depressed or suicidal and more hopeful after speaking with a trained crisis counselor. This announcement highlights the addition of Spanish text and chat services to this program, which will aim to help support even more communities and individuals. More information on this announcement can be found here.
• On July 13, 2023, CMS Administrator, Chiquita Brooks-LaSure, sent a letter to payers (e.g., Medicare, private insurers, and state Medicaid and Children’s Health Insurance Program (CHIP)) to clarify changes to coverage of COVID-19 vaccines following the upcoming shift away from U.S. Government purchasing of vaccines to a more traditional commercial market. Administrator Brooks-LaSure noted that, according to the Coronavirus Aid, Relief, and Economic Security (CARES) Act, Medicare and MA plans are required to cover COVID-19 vaccinations without cost-sharing as part of beneficiaries’ Part B coverage. Medicaid and CHIP programs are also required to cover COVID-19 vaccines without cost-sharing for nearly all beneficiaries through September 30, 2024 under the American Rescue Plan Act (ARP). States’ Medicaid and CHIP payments will be federally matched at 100 percent until September 30, 2024 and at the applicable state federal medical assistance percentage (FMAP) after that date. Finally, Administrator Brooks-LaSure stated that most private health insurance that is subject to the Affordable Care Act (ACA) are required to cover COVID-19 vaccines authorized for emergency use or recommended by the Advisory Committee on Immunization Practices (ACIP) without patient cost-sharing. More information on this announcement can be found here.

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