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, HHS Secretary Becerra appeared before Senate Committees to discuss the President's FY 2024 budget and HRSA announced modernization efforts for the organ transplant network. Read more about these actions and other news below.
I. Regulations, Notices & Guidance
- On March 20, 2023, the Centers for Disease Control and Prevention (CDC) issued a notice entitled, Recommendations for Hepatitis B Screening and Testing – United States, 2022. In 2022, CDC determined that CDC Recommendations for Hepatitis B Screening and Testing — United States, 2022 constituted influential scientific information (ISI) that will have a clear and substantial impact on important public policies and private sector decisions. As such, five clinicians with expertise in hepatology, gastroenterology, internal medicine, infectious diseases, and/or pediatrics provided structured peer reviews. CDC also received 28 public comments on the recommendations. Upon reviewing these comments, CDC finalized the recommendations. The final document was published as an MMWR Reports & Recommendations on March 10, 2023.
- On March 20, 2023, the Health Resources and Services Administration (HRSA) issued a notice entitled, Solicitation of Nominations for Membership to Serve on the Council on Graduate Medical Education. HRSA is seeking nominations of qualified candidates for consideration for appointment as members of the Council on Graduate Medical Education (COGME or Council). COGME provides advice and recommendations on policy, program development, and other matters of significance concerning the physician training and the physician workforce. Issues addressed by COGME include the supply and distribution of the physician workforce in the U.S., including any projected shortages or excesses of physicians in medical and surgical specialties and subspecialities; international medical graduates; the nature and financing of undergraduate and graduate medical education; appropriation levels for certain programs under title VII of the Public Health Service Act (PHS Act); and deficiencies in databases of the supply and distribution of the physician workforce and postgraduate programs for training physicians. Nominations will be accepted on a continuous basis.
- On March 21, 2023, HRSA issued a notice entitled, Low-Income Levels Used for Various Health Professions and Nursing Programs Authorized in the Public Health Service Act. HRSA is updating income levels used to identify a “low-income family” for the purpose of determining eligibility for programs that provide health professions and nursing training to individuals from disadvantaged backgrounds. These various programs are authorized in the PHS Act. HHS periodically publishes in the Federal Register, low-income levels to be used by institutions receiving grants or cooperative agreement awards to determine eligibility for programs providing training for disadvantaged individuals, individuals from disadvantaged backgrounds, or individuals from low-income families.
- On March 21, 2023, the Department of Health and Human Services (HHS) issued a proposed rule entitled, Administrative Simplification: Adoption of Standards for Health Care Attachments Transactions and Electronic Signatures, and Modification to Referral Certification and Authorization Transaction Standard; Extension of Comment Period. This rule would implement requirements of the Administrative Simplification subtitle of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) and the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act of 2010, enacted on March 30, 2010—collectively, the Affordable Care Act. Specifically, this proposed rule would adopt standards for “health care attachments” transactions, which would support both health care claims and prior authorization transactions, and a standard for electronic signatures to be used in conjunction with health care attachments transactions. To better support the use of the proposed standards for attachments transactions with prior authorization transactions, this rule also proposes to adopt a modification to the standard for the referral certification and authorization transaction (X12 278) to move from Version 5010 to Version 6020. The comment period for the proposed rule, which would end on March 21, 2023, is extended until April 21, 2023.
- On March 22, 2023, the Agency for Healthcare Research and Quality (AHRQ) issued a request for information (RFI) entitled, Potential Consumer Assessment of Healthcare Providers and Systems Survey on Prenatal and Childbirth Care Experiences in Ambulatory and Inpatient Settings. AHRQ invites public comment in response to this RFI about a potential Consumer Assessment of Healthcare Providers and Systems (CAHPS®) survey to assess patients’ prenatal care and childbirth care experiences in ambulatory and inpatient care settings. Currently, no CAHPS instrument is available that is specifically designed to measure prenatal and childbirth care from the patient’s perspective in these settings. Accordingly, this RFI seeks comments regarding methodologically sound approaches to assessing prenatal and childbirth care experiences in healthcare settings about topics such as communication with providers, respect, access to services, and patients’ perceptions of bias in receiving care. This RFI also seeks comments about any (1) existing patient experience surveys or survey items that might be incorporated into public domain CAHPS ambulatory and inpatient prenatal and childbirth experience surveys; and (2) special considerations or concerns associated with the collection of such information. This RFI will help inform the development of scientifically sound surveys to potentially measure the experience of patients receiving prenatal and childbirth care. Comments must be received by May 5, 2023.
- On March 22, 2023, FDA issued a notice entitled, Changes to Third-Party Vendors for Risk Evaluation and Mitigation Strategies; Establishment of a Public Docket; Request for Comments. FDA is announcing the establishment of a docket to solicit comments on factors that generally should be considered by the Secretary of HHS when reviewing modification requests from sponsors of drugs subject to risk evaluation and mitigation strategies (REMS) related to changes in third-party vendors engaged by sponsors to aid in implementation and management of the strategies. Comments must be received by July 21, 2023.
- On March 23, 2023, FDA issued a notice entitled, Framework for the Use of Digital Health Technologies in Drug and Biological Product Development. FDA is announcing the publication of a digital health technology (DHT) framework by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER). This framework is entitled “Framework for the Use of Digital Health Technologies in Drug and Biological Product Development.” This fulfills an FDA commitment under the seventh iteration of the Prescription Drug User Fee Act (PDUFA VII) reauthorization, incorporated as part of the FDA User Fee Reauthorization Act of 2022. The framework will guide activities such as: (1) defining objectives for workshops and demonstration projects; (2) developing methodologies for evaluating DHTs proposed as measuring key (primary or important secondary) endpoints or other important measures (e.g., for safety monitoring or baseline characterization) in clinical trials; (3) managing submissions with extensive and continuous data (e.g., in order to develop acceptable approaches to capture adverse events); and (4) developing a standardized process for data management and analysis of large datasets from DHTs.
- On March 24, 2023, FDA issued draft guidance entitled, Clinical Trial Considerations to Support Accelerated Approval of Oncology Therapeutics. The purpose of this guidance is to provide recommendations to sponsors of anti-cancer drugs or biological products on considerations for designing trials intended to support accelerated approval. The accelerated approval pathway is commonly used for approval of oncology drugs due to the serious and life-threatening nature of cancer. Although single-arm trials have been commonly used to support accelerated approval, a randomized controlled trial is the preferred approach as it provides a more robust efficacy and safety assessment and allows for direct comparisons to an available therapy. This guidance describes considerations for designing, conducting, and analyzing data for trials intended to support accelerated approvals of oncology therapeutics.
- On March 24, 2023, FDA issued final guidance entitled, Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) Related to Coronavirus Disease 2019 (COVID-19). FDA recognizes that it will take time for device manufacturers, device distributors, healthcare facilities, healthcare providers, patients, consumers, and FDA to adjust from policies adopted and operations implemented during the COVID-19 pandemic to “normal operations.” To provide a clear policy for all stakeholders and FDA staff, the Agency is issuing this guidance to describe FDA’s general recommendations for this transition process with respect to devices issued EUAs related to COVID-19, including recommendations regarding submitting a marketing submission, as applicable, and taking other actions with respect to these devices.
- On March 24, 2023, FDA issued final guidance entitled, Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency. FDA recognizes that it will take time for device manufacturers, device distributors, healthcare facilities, healthcare providers, patients, consumers, and FDA to adjust from policies adopted and operations implemented during the COVID-19 public health emergency (PHE) to “normal operations.” To provide a clear policy for all stakeholders and FDA staff, the Agency is issuing this guidance to describe FDA’s general recommendations for a phased transition process with respect to devices that fall within certain enforcement policies issued during the COVID-19 PHE declared by the Secretary of HHS under the PHS Act, including recommendations regarding submitting a marketing submission, as applicable, and taking other actions with respect to these devices. This guidance applies to devices that fall within enforcement policies in guidances included in List 1 of this guidance. The phased transition process outlined in this guidance will begin on the “implementation date.” The implementation date is the day the PHE expires or 45 days after the finalization of this guidance, whichever comes later. Because the COVID-19 section 319 PHE declaration is anticipated to expire at least 45 days after the finalization of this guidance, or May 11, 2023, the implementation date is that date. The guidances in List 1 of this guidance will no longer be in effect after the 180-day transition period ends.
- On March 24, 2023, FDA issued a notice entitled, Over-the-Counter Monograph Drug User Fee Rates for Fiscal Year 2023. FDA is announcing the fee rates under the over-the-counter (OTC) monograph drug user fee program (OMUFA) for fiscal year (FY) 2023. The FD&C Act authorizes FDA to assess and collect user fees from qualifying manufacturers of OTC monograph drugs and submitters of OTC monograph order requests. This notice publishes the OMUFA fee rates for FY 2023. These fees are effective on October 1, 2022, and will remain in effect through September 30, 2023.
- April 20, 2023: HHS announced a public meeting of the National Advisory Committee on Individuals with Disabilities and Disasters (NACIDD). The NACIDD evaluates issues and programs and provide findings, advice, and recommendations to the Secretary of HHS and the Administration for Strategic Preparedness and Response (ASPR) to support and enhance all-hazards public health and medical preparedness, response, and recovery aimed at meeting the needs of people with disabilities.
- April 26, 2023: The Substance Abuse and Mental Health Services Administration (SAMHSA) announced a joint meeting of four of its advisory councils: 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). The meeting will include remarks from the Assistant Secretary for Mental Health and Substance Use; SAMHSA’s updates by the Centers and Office Directors; a presentation and discussion addressing the children’s mental health crisis; discussion/feedback on how to improve the mental health and substance use disorders services during a PHE; and a presentation and discussion on the impact on fentanyl in American communities.
- April 27, 2023: SAMHSA announced a meeting of the National Advisory Council (NAC). The meeting will include, but not be limited to, remarks from the Assistant Secretary for Mental Health and Substance Use; approval of the meeting minutes of August 10, 2022; updates and recap of the joint meetings of the councils (JNAC) and Lessons Learned; presentations on initiatives by the National Mental Health and Policy Laboratory (Policy Lab); update on the Strategic Plan and Public Comment Response; and overview of the Evidence-Based Practices Resource Center with group discussion; a presentation and discussion regarding the integration of equity; updates on the Interagency Task Force on Trauma Informed Care (TIC Task Force); updates on the Interdepartmental Serious Mental Illness Coordinating Committee (ISMICC); updates on the Interdepartmental Substance Use Disorders Coordinating Committee (ISUDCC); Council discussion and public comments.
- May 1-2, 2023: The National Institutes of Health (NIH) announced an open meeting of the National Advisory Board on Medical Rehabilitation Research (NABMRR) in the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). The first day’s agenda will include: National Center for Medical Rehabilitation Research (NCMRR) Director's report; NCMRR Portfolio Analysis; report out on NCMRR conferences; Research Talk: Therapeutic Strategies to Maximize Development in Children with Neuromotor Disorders; Research Talk: Neural and Biomechanical Contributors to Posture and Movement; training and career development breakout groups. The second day’s agenda will include: NICHD Director's report; report out from Breakout Groups and Training Work Group formation; Science Talk: Knowledge Translation; Concept Clearance; comments from retiring board members; planning for the next board meeting in December 2023.
- May 11, 2023: CDC announced a public meeting of the Advisory Committee to the Director (ACD). The agenda will include discussions regarding CDC’s current and future work in the following topic areas: (1) communications; (2) laboratory quality; (3) global health; (4) health equity; (5) response readiness; and (6) data and surveillance. The ACD will hear reports from its workgroups on data and surveillance, laboratory quality, and health equity topics. In addition, the ACD will hear an update on communications, global health, and response readiness.
- May 12, 2023: NIH announced a partially open meeting of the National Advisory Council of the National Center for Complementary & Integrative Health (NCCIH). The open agenda will include reports and updates about recent and ongoing NCCIH-led or involved activities by NCCIH staff and its director. The closed agenda will include review and evaluation of grant applications.
- May 15-16, 2023: NIH announced a partially open meeting of the National Advisory Council of the National Human Genome Research Institute (NHGRI). The open agenda will include a report from the NHGRI director and staff. The closed agenda will include review and evaluation of grant applications as well as a presentation of the NHGRI Board of Scientific Counselors (BSC) report.
- May 16, 2023: NIH announced a symposium to be held by the Office of Research on Women’s Health (ORWH) entitled, Menopause and Optimizing Midlife Health of Women. The symposium will discuss menopausal transition, accumulation of morbidity after menopause, menopause in special populations, social determinants of health, menopausal hormonal therapy, and interventions to promote healthy aging.
- May 18, 2023: NIH announced a partially open meeting of the National Advisory Council of the National Institute of General Medical Sciences (NIGMS). The open agenda will include discussion of program policies and issues; opening remarks; report of the NIGMS Director; and other business of the Council. The closed agenda will include review and evaluation of grant applications.
II. Hearings & Markups
U.S. House of Representatives
- On March 23, 2023, the House Committee on Appropriations held its Public Witness Day - Labor, Health and Human Services, Education, and Related Agencies. Witnesses present included: Mr. Jared C. Bass, Senior Director for Higher Education, Center for American Progress (CAP); Ms. Katherine Brunett McGuire, Chief Advocacy Officer, American Psychological Association Services (APA Services); Mr. Clarke Forsythe, Senior Counsel, Americans United for Life (AUL); Ms. Katie Hoff Anderson, Olympic Medalist and Pulmonary Embolism Survivor, National Blood Clot Alliance (NBCA); Mr. Michael Kutcher, Cerebral Palsy and Disability Advocate, Cerebral Palsy Foundation (CPF); Mr. Kevin Longino, Chief Executive Officer (CEO), National Kidney Foundation(NKF); Ms. Amanda Peel Crowley, Founding Member, National Alliance for Pediatric Acute-Onset Neuropsychiatric Syndrome (PANS) & Pediatric Autoimmune Neuropsychiatric Disorders Associated with Streptococcus (PANDAS); Dr. Brian Persing M.D., Medical Oncologist and Hematologist, Association for Clinical Oncology; Mr. Jonathan Plucker, Professor of Education, Johns Hopkins University School of Education; Ms. Sarah Rittling, Executive Director, First Five Years Fund (FFYF); Mr. Paul W. Schroeder, Vice President for Impact and Outreach, American Printing House for the Blind (APH); Ms. Felicia Simpson, Co-Director, Alabama Expanded Learning Alliance (AELA); Dorothea Staursky, Volunteer and Bone Marrow Donor, National Marrow Donor Program (NMDP); Mr. Richard Stern, Director, Grover M. Hermann Center for the Federal Budget, The Heritage Foundation; Ms. Amy Templeton, President & CEO, McWane Science Center, on behalf of American Alliance of Museums (AAM); Dr. Yolanda Wilson, President, College of Southern Maryland; Dr. Anne Zink M.D., FACEP, President & CEO, Association of State and Territorial Health Officials & Alaska Department of Health.
- On March 23, 2023, the House Committee on Ways and Means Subcommittee on Health hearing entitled, Why Health Care is Unaffordable: The Fallout of Democrats’ Inflation on Patients and Small Businesses. Witnesses present included: Kelly Moore, Owner, NAPA Auto Parts; Matt Niswander, NP, Owner and Nurse Practitioner, Niswander Family Medicine; Brian Blase, Ph.D., President, Paragon Health Institute; Karen Kerrigan, President & CEO, Small Business & Entrepreneurship Council; and Patricia Kelmar, Senior Director of Health Care Campaigns, U.S. Public Interest Research Group.
- On March 23, 2023, the House Committee on Energy and Commerce held a markup entitled, Full Committee Markup Of 19 Bills. Health-related bills that were heard include: H.R. 498, the 9-8-8 Lifeline Cybersecurity Responsibility Act; H.R. 485, the Protecting Health Care for All Patients Act of 2023; R. 467, the Halt All Lethal Trafficking of Fentanyl Act; and H.R. 801, the Securing the Border for Public Health Act of 2023.
- On March 22, 2023, the Senate Committee on Health, Education, Labor and Pensions (HELP) held a hearing entitled, Taxpayers Paid Billions For It: So Why Would Moderna Consider Quadrupling the Price of the COVID Vaccine? Witnesses present included: Stéphane Bancel, M.B.A., M.Eng., M.Sc., CEO and Director, Moderna, Inc.; Christopher J. Morten, Ph.D., J.D., Associate Clinical Professor of Law, Columbia Law School; Ameet Sarpatwari, Ph.D., J.D., Assistant Professor of Medicine, Harvard Medical School; and Craig Garthwaite, Ph.D., M.P.P., Herman Smith Research Professor in Hospital and Health Services Management, Kellogg School of Management, Northwestern University.
- On March 22, 2023, the Senate Committee on Homeland Security & Governmental Affairs (HSGAC) held a hearing entitled, Drug Shortage Health and National Security Risks: Underlying Causes and Needed Reforms. Witnesses present included: Andrew Shuman, M.D., Associate Professor of Otolaryngology-Head and Neck Surgery and Chief of the Clinical Ethics Service Center for Bioethics and Social Sciences in Medicine, University of Michigan Medical School; Vimala Raghavendran, Vice President Informatics Product Development, U.S. Pharmacopeia; Erin Fox, Pharm.D., Associate Chief Pharmacy Officer of Shared Services and Adjunct Professor, College of Pharmacy, University of Utah; and John C. Goodman, PH.D., President, Goodman Institute for Public Policy Research.
- On March 22, 2023, the Senate Committee on Finance held a hearing entitled, The President’s Fiscal Year 2024 Health and Human Services Budget. Witnesses present included the Honorable Xavier Becerra, Secretary, HHS.
- On March 22, 2023, the Senate Committee on Appropriations Subcommittee on Labor, Health and Human Services, Education, and Related Agencies held a hearing entitled, A Review of the President’s FY 2024 Funding Request and Budget Justification for the Department of Health and Human Services. Witnesses present included: the Honorable Xavier Becerra, Secretary, HHS.
III. Reports, Studies & Analyses
- On March 20, 2023, the Government Accountability Office (GAO) published a report entitled, COVID-19 in Nursing Homes: Experts Identified Actions Aimed at Improving Infection Prevention and Control. Nursing home residents were one of the most vulnerable populations during the COVID-19 pandemic. In fact, even prior to the pandemic, infections were a leading cause of hospitalization and death in nursing homes. GAO conducted this study to review federal oversight in nursing homes as a result of the pandemic and actions HHS took to improve infection prevention and control practices. Specifically, GAO convened a roundtable of 13 experts to identify actions HHS should continue, enhance, or stop in order to improve infection prevention and control in nursing homes. Examples of actions GAO recommended HHS should continue include: (1) continuing to require data reporting to the National Healthcare Safety Network (NHSN) and (2) deploying strike teams. Examples of actions GAO recommended HHS should enhance include: (1) developing staffing solutions and (2) strengthening the use of non-monetary enforcement actions. Examples of actions GAO advised that HHS should discontinue include limiting visitation or group activities.
- On March 21, 2023, the Congressional Research Service (CRS) published a report entitled, Overview of the Emergency Medical Treatment and Active Labor Act (EMTALA) and Emergency Abortion Services. EMTALA is a federal law that requires Medicare-certified hospitals to provide emergency care to any individual, regardless of their ability to pay. However, questions of EMTALA’s application have been called into question given the recent Supreme Court decision in Dobbs v. Jackson Women’s Health Organization (Dobbs) which overturned constitutional protections on the right to abortion. As such, CRS published this report to detail EMTALA’s provisions and enforcement, how it relates to abortion services, and considerations for Congress. Particularly, the report notes that an emergency medical condition would fall under EMTALA if the health of a woman or her unborn child are in danger. For example, physicians must render treatment to pregnant patients in emergency departments who are experiencing conditions that are likely to become emergencies, as well as those who require an abortion as stabilizing treatment. CRS concluded the report by urging Congress to consider how to improve health care access and cost in emergent situations, clarify EMTALA’s scope, and address how EMTALA interacts with state laws related to emergency abortion care.
- On March 22, 2023, CRS published a report entitled, State Laws Restricting or Prohibiting Abortion. Following the Supreme Court’s Dobbs decision, CRS published this report to provide an overview of existing, recently passed, or “triggered” state laws prohibiting or limiting abortion prior to 24 weeks’ gestational age. Trigger laws are laws that would go into effect if Roe v. Wade was overturned. 24 weeks is generally considered the point of viability for an unborn child, although medical advancements may have moved the point of viability earlier in gestational age. CRS acknowledged that the report may not be comprehensive, as some laws are not in effect due to court injunctions and not all state statutes may have been captured in the database search. The report details laws that passed since June 24, 2022, when the Supreme Court issued the Dobbs decision; laws that were triggered upon the Dobbs decision; laws passed prior to the Dobbs decision; laws prohibiting abortion once cardiac activity is detected in the fetus; and laws prohibiting abortion after eight-, 15-, 18-, 20-, 22-, and 24-weeks’ gestational age.
- On March 23, 2023, GAO published a report entitled, Regenerative Medicine and Advanced Therapies: Information on Workforce and Education. GAO conducted this study to review the regenerative medicine and advanced therapies (e.g., cell, gene, and tissue-based therapies) workforce in the commercial and academic sectors. The goal of regenerative medicine and advanced therapies is to repair or replace damaged human cells, tissues, or organs to supplement or restore function. They require a multidisciplinary and diverse workforce to help treat and identify underlying causes for previously untreatable diseases and conditions. Examples of individuals who could comprise a team include scientists, biomanufacturing associates, clinical staff, medical technologists, and regulatory affairs consultants. In their review, GAO found that individuals working with regenerative medicine and advanced therapies need advanced degrees and specialized training. Stakeholders GAO interviewed shared that there were many shortages across the workforce, in part due to the high education necessary to enter the field. Stakeholders also recommended establishing a core nationally recognized curriculum to support a competent workforce.
- On March 23, 2023, CRS published a report entitled, Digital Biology: Implications of Genetic Sequencing. Gene synthesis technologies can both read and write DNA that enable researchers to reprogram cellular systems for specific functional outputs. Examples of massive genetic sequencing efforts include: (1) NIH’s All of Us precision medicine research program, which aims to collect clinical, lifestyle, and genomic data from one million people to advance the development of precision medicine; and (2) the White House Office of Science and Technology Policy (OSTP)’s 2023 goal to sequence one million microbial species’ genomes within five years. This work requires access to large and comprehensive data sets that can then be interpreted and stored by various advanced technologies, including artificial intelligence (AI). Sequencing and related capabilities have raised concerns over who is collecting the data, where the data is being stored, what the data is and can be used for, and who owns the data. Although there are some international governance standards as to how genomic sequencing information can be used, stored, or shared, concerns about biosafety, biosecurity, and national security remain. The report urges policymakers to consider how current federal efforts to research, collect, use, and store genomic sequence data may affect U.S. competitiveness and national security. The report also recommends that Congress consider whether the federal government should regulate genomic data.
IV. Other Health Policy News
- On March 20, 2023, HHS announced a new office under the Administration for Children and Families (ACF) entitled, the Office of Family Violence Prevention and Services (OFVPS). OFVPS will prioritize activities related to addressing and preventing domestic violence, intimate partner violence, and dating violence. The office will also provide survivor services and a whole-family-approach to promote violence prevention. OFVPS has identified three priority goals: (1) develop an ACF-wide strategy for preventing and responding to domestic violence across all programs, (2) collaborate across agency partners, and (3) prioritize continued implementation appropriations to survivors of domestic violence and sexual assault. More information on this announcement can be found here.
- On March 21, 2023, HHS and the Department of Commerce (DOC) announced joint efforts to review their march-in authority under the Bayh-Dole Act, which allows entities who commercialize inventions developed using public funds to retain ownership and seek patents. The also Bayh-Dole Act allows the federal government to retain residual rights and ownership of inventions created using federal funds, including the right to grant licenses to third parties when such an invention is not reasonably available to the public, which is known as the march-in authority. HHS’ and DOC’s efforts also include the creation of the Interagency Working Group for Bayh-Dole, which will develop a framework for consistent implementation of the march-in provision under the Bayh-Dole Act. More information on this announcement can be found here.
- On March 22, 2023, HRSA announced a Modernization Initiative to strengthen accountability, equity, and performance in the organ donation and transplantation system, known as the Organ Procurement and Transplantation Network (OPTN). The plan will focus on five areas of reform: (1) technology, (2) data transparency, (3) governance, (4) operations, and (5) quality improvement and innovation. Examples of efforts HRSA plans to pursue under this initiative include data dashboards that detail organization-level data (e.g., on organ retrieval timeline, waitlist outcomes, demographic data, etc.) and soliciting contracts for multiple awards to manage the OPTN to foster competition. The President’s FY 2024 budget also includes $67 million, an increase of $36 million over FY 2023, for HRSA’s organ-related work and requests Congress to remove the ceiling on the amount that can be awarded to vendors for the OPTN under the National Organ Transplant Act (NOTA). These efforts aim to improve the organ matching process as well as patient safety and health. More information on this announcement can be found here.
- On March 23, 2023, the Centers for Medicare & Medicaid Services (CMS) highlighted record-breaking enrollment numbers during the 2023 Marketplace Open Enrollment Period (OEP). Nearly 16.4 million customers selected or re-enrolled in HealthCare.gov Marketplaces and State-based Marketplaces (SBMs) during the 2023 OEP, representing a 13 percent increase from 2022 and a 26 percent increase from 2021. During the 2023 OEP, 92 percent of HealthCare.gov enrollees had access to plans from three or more insurance companies, reflecting the competitive Marketplace. The Biden Administration emphasized that competition, along with subsidies and tax credits provided by the American Rescue Plan (ARP) Act and Inflation Reduction Act (IRA), allowed customers to save an average of $800 in premiums per year. The Biden Administration also invested $98.9 million in Navigator grant funding for the 2023 OEP to help customers navigate the Marketplace and reduce disparities among those who seek and receive coverage. More information on this announcement can be found here.
- On March 24, 2023, SAMHSA announced two funding opportunities totaling $123.6 million for Certified Community Behavioral Health Clinic (CCBHC) expansion: (1) the CCBHC Planning, Development, and Implementation (CCBHC-PDI) grant which will help clinics establish new CCBHC programs, and (2) the CCBHC Improvement and Advancement (CCBHC–IA) grant which will support existing CCBHCs. CCBHCs are community-based behavioral health outpatient clinics that provide a range of services, including crisis care, 24/7. They see people in crisis immediately, provide outpatient care, and support care coordination activities for other services a patient may need. Proponents assert that CCBHCs have demonstrated their ability to transform the mental health and substance use treatment system. For example, data shows that within the first six months of receiving care, CCBHCs decrease homelessness, the time spent in emergency rooms for mental health reasons, and the use of illegal substances. Additionally, the President’s FY 2024 budget proposes to make a CCBHC Medicaid demonstration program, which allows CCBHCs to receive Medicaid reimbursement at competitive rates for comprehensive services, permanent. More information on this announcement can be found here.
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