Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies, and analyses; and other health policy news.
Week in Review Highlight of the Week:
This week, the Centers for Medicare & Medicaid Services released the final part two guidance for the Medicare Prescription Payment Plan intended to reduce high out-of-pocket prescription drug costs for Medicare beneficiaries.
I. Regulations, Notices & Guidance
- On July 15, 2024, the Centers for Medicare & Medicaid Services (CMS) released a notice entitled, Medicare and Medicaid Programs: Application by DNV Healthcare USA Inc. for Continued CMS Approval of Its Psychiatric Hospital Accreditation Program. This notice acknowledges the approval of an application from DNV Healthcare USA Inc. for continued CMS approval as a national accrediting organization for psychiatric hospitals that wish to participate in the Medicare or Medicaid programs.
- On July 15, 2024, the Administration for Community Living (ACL) released a notice entitled, Announcing the Intent to Award a Single-Source Supplement for the National Paralysis Resource Center (PRC). ACL announced the intent to award a single-source supplement to the current cooperative agreement held by the Christopher and Dana Reeve Foundation. The National Paralysis Resource Center (NPRC) is operated by the Christopher and Dana Reeve Foundation and offers important programmatic opportunities for persons with disabilities and older adults. The NPRC provides comprehensive information for people living with spinal cord injury, paralysis, and mobility-related disabilities and their families. Resources include information and referral by phone and email in multiple languages; a peer and family support mentoring program; a military and veterans’ program; multicultural outreach services; multiple quality of life grants; and a national website. The administrative supplement for fiscal year (FY) 2024 will be in the amount of $1,300,000, bringing the total award for FY 2024 to $10,000,000.
- On July 16, 2024, CMS released a notice entitled, Medicare Program; Alternative Payment Model (APM) Incentive Payment Advisory for Clinicians-Request for Current Billing Information for Qualifying APM Participants. This advisory is to alert certain clinicians who are Qualifying APM participants (QPs) and have earned an APM Incentive Payment that CMS does not have the current information needed to disburse the payment. This advisory provides information to QPs on how to update their Medicare billing information so that CMS can disburse APM Incentive Payments.
- On July 16, 2024, the Food and Drug Administration (FDA) released a notice entitled, Notice of Approval of Product Under Voucher: Rare Pediatric Disease Priority Review Voucher; VYVGART HYTRULO (efgartigimod alfa and hyaluronidase-qvfc). FDA announced the issuance of approval of a product redeeming a priority review voucher. The Federal Food, Drug, and Cosmetic Act (FD&C Act) authorizes FDA to award priority review vouchers to sponsors of approved rare pediatric disease product applications that meet certain criteria. FDA is required to publish notice of the issuance of priority review vouchers as well as the approval of products redeeming a priority review voucher. FDA has determined that the supplemental application (Supplement-5) for VYVGART HYTRULO (efgartigimod alfa and hyaluronidase-qvfc), approved June 21, 2024, meets the criteria for redeeming a priority review voucher.
- On July 16, 2024, FDA released a notice entitled, Platform Technology Designation Program; Draft Guidance for Industry; Extension of Comment Period. FDA is extending the comment period for the draft guidance for industry entitled Platform Technology Designation Program for Drug Development that appeared in the Federal Register on May 29, 2024. In the notice of availability for the draft guidance, FDA requested comments on the proposed collection of information. FDA is taking this action in response to requests for an extension to allow interested persons additional time to submit comments.
- On July 17, 2024, the Centers for Disease Control and Prevention (CDC) released a notice entitled, Solicitation of Nominations for Appointment to the Advisory Committee on Immunization Practices. CDC is seeking nominations for membership on the Advisory Committee on Immunization Practices (ACIP). The ACIP consists of up to 19 experts in fields associated with immunization practices and public health, use of vaccines and other immunobiological agents in clinical practice or preventive medicine, clinical or laboratory vaccine research, assessment of vaccine efficacy and safety, or have knowledge about consumer perspectives and/or social and community aspects of immunization programs.
- On July 17, 2024, CMS released a notice entitled, Medicare and Medicaid Programs: Application From The Joint Commission for Continued Approval of Its Ambulatory Surgical Center (ASC) Accreditation Program. This notice announces CMS’s decision to approve The Joint Commission for continued recognition as a national accrediting organization for ambulatory surgical centers that wish to participate in the Medicare or Medicaid programs.
- On July 17, 2024, FDA issued guidance entitled, Blood Pressure and Pulse Donor Eligibility Requirements: Compliance Policy; Guidance for Industry; Availability. The guidance document addresses certain regulatory requirements for determining donor eligibility that apply to blood establishments that collect blood and blood components for transfusion or for further manufacturing use, including source plasma. In a final rule dated May 22, 2015, FDA amended the regulations applicable to blood establishments for determining donor eligibility and testing blood and blood components. The revised requirements were implemented in order to assure the safety of the blood supply and to protect donor health. This guidance finalizes the draft guidance entitled Blood Pressure and Pulse Donor Eligibility Requirements: Compliance Policy; Draft Guidance for Industry issued on May 24, 2022.
- On July 17, 2024, FDA issued guidance entitled, Clinical Pharmacology Considerations for Human Radiolabeled Mass Balance Studies; Guidance for Industry; Availability. This guidance describes FDA’s recommendations regarding clinical pharmacology considerations for conducting human radiolabeled mass balance studies, including deciding whether and when to conduct the study, designing the study, and reporting results.
- On July 18, 2024, CDC released a notice entitled, Solicitation of Nominations for Appointment to the Lead Exposure and Prevention Advisory Committee. CDC is soliciting nominations for membership on the Lead Exposure and Prevention Advisory Committee (LEPAC). The LEPAC is composed of not more than 15 members and not less than half of the members must be Federal members in fields associated with lead screening, the prevention of lead exposure, and services for individuals and communities affected by lead exposure.
- On July 18, 2024, FDA issued guidance entitled, Pediatric Inflammatory Bowel Disease: Developing Drugs for Treatment; Draft Guidance for Industry; Availability. The draft guidance was prepared by the Division of Gastroenterology in the Center for Drug Evaluation and Research at FDA to help sponsors in the clinical development of drugs to treat pediatric patients with inflammatory bowel disease. The draft guidance provides FDA’s recommendations about the necessary attributes of clinical studies for drugs being developed for the treatment of pediatric ulcerative colitis or pediatric Crohn's disease, including study population, study design, efficacy considerations, and safety assessments.
- On July 19, 2024, CMS released a notice entitled, Medicare and Medicaid Programs; Quarterly Listing of Program Issuances— April through June 2024. This quarterly notice lists CMS manual instructions, substantive and interpretive regulations, and other Federal Register notices that were published from April to June 2024 relating to the Medicare and Medicaid programs and other programs administered by CMS.
- On July 19, 2024, FDA issued guidance entitled, Recommendations for Investigational and Licensed COVID-19 Convalescent Plasma; Guidance for Industry; Availability. The purpose of this guidance is to provide FDA’s recommendations to blood establishments for the submission of a Biologics License Application (BLA) for the manufacture of COVID-19 convalescent plasma intended for transfusion in patients with immunosuppressive disease or receiving immunosuppressive treatment in either the outpatient or inpatient setting. The guidance also provides FDA’s recommendations for investigational new drug applications (INDs) for investigational COVID-19 convalescent plasma for transfusion.
- On July 19, 2024, the Substance Abuse and Mental Health Services Administration (SAMHSA) released a notice entitled, FY 2024 Notice of Supplemental Funding Opportunity. SAMHSA is supporting administrative supplements in scope of the parent award for the 10 eligible grant recipients funded under the FY 2022 Rural Opioid Technical Assistance Regional Centers (ROTA-R), Notice of Funding Opportunity (NOFO). Each recipient may receive up to $650,000, for a total award amount of $6,500,000. This supplemental funding will extend the project period by one year. The supplemental funding will be used to continue to implement regional centers of excellence to develop and disseminate training and technical assistance addressing opioid and stimulant misuse affecting rural communities. Recipients will continue the identification of model programs; develop and update materials related to the prevention, harm reduction, treatment; and recovery activities for opioid use disorder (OUD) and/or stimulant use disorder, and ensure that high-quality training is provided.
Event Notices
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 7-8, 2024: CDC announced a meeting of the Advisory Board on Radiation and Worker Health. This is a virtual meeting 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 22, 2024: CDC announced a meeting of the Board of Scientific Counselors, National Institute for Occupational Safety and Health. This is a hybrid 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: 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.
August 28-29, 2024: The Department of Health and Human Services (HHS) announced a meeting of the Presidential Advisory Council on HIV/AIDS. This is a virtual meeting open to the public.
September 10-11, 2024: CDC announced a meeting of the ICD-10 Coordination and Maintenance Committee. This is a virtual meeting open to the public.
II. Reports, Studies, & Analyses
- On July 15, 2024, the Bipartisan Policy Center released an issue brief entitled, Positioning Telehealth Policy to Ensure High-Quality, Cost-Effective Care. The report urges Congress to act to preserve Medicare’s telehealth flexibilities, set to expire at the end of 2024. While an extension is likely, long-term policies are needed to ensure sustainable reimbursement and high-quality virtual care. Bipartisan proposals are underway to extend telehealth provisions through 2026, with key House committees advancing relevant legislation. The report offered evidence-based recommendations for telehealth policies, including: 1) developing long term reimbursement strategies; 2) ensuring high quality virtual care through appropriate oversight; and, 3) exploring permanent telehealth flexibilities such as the removal of originating site restrictions and repealing in-person visit requirements for telehealth mental health services.
III. Other Health Policy News
- On July 16, 2024, the Biden Administration announced the final part two guidance for the Medicare Prescription Payment Plan, which is part of the Inflation Reduction Act and intended to reduce high out-of-pocket prescription drug costs for Medicare beneficiaries. This guidance updates and finalizes requirements proposed in the draft part two guidance released in February 2024. Starting in 2025, Medicare beneficiaries will be able to spread their prescription drug costs over the calendar year instead of paying the full amount at the pharmacy counter. Additionally, annual out-of-pocket prescription drug costs will be capped at $2,000, providing financial relief to beneficiaries. This final guidance governs plan education and outreach activities to ensure beneficiaries, especially those with high prescription drug costs, are aware of and can benefit from this new payment option. A press release with more information is available here. The guidance is available here.
- On July 16, 2024, the Biden Administration announced an initiative to establish a multi-state social worker licensure compact to enhance access to mental health and substance use disorder treatment and address workforce shortages. This effort, led by HRSA, marks the first-ever investment in the Licensure Portability Grant Program for social workers. By enabling health care providers to practice across state lines without needing individual state licenses, the initiative aims to improve access to services and facilitate telehealth, especially in underserved and rural communities. HRSA’s $2.5 million investment will support the development of the social worker licensure compact and continue support for primary care, psychology, and podiatry compacts. The investment also aims to expand behavioral health care and reduce licensure barriers. The announcement, made at HRSA’s National Telehealth Conference, underscores the critical role of social workers in addressing key health issues like children’s mental health, the opioid crisis, and maternal depression. A press release with more information is available here.
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