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:
On Wednesday, HHS finalized its review of Phase 3 Provider Relief Fund applications and began distribution of the funds. Read more about this action and other news below.
I. Regulations, Notices & Guidance
- On December 14, 2020, the Department of Health and Human Services (HHS), along with several other agencies, issued a final rule entitled, Equal Participation of Faith-Based Organizations in the Federal Agencies’ Programs and Activities. This rule provides clarity about the rights and obligations of faith-based organizations participating in the Agencies’ Federal financial assistance programs and activities. This rulemaking is intended to ensure that the Agencies’ Federal financial assistance programs and activities are implemented in a manner consistent with the requirements of Federal law, including the First Amendment to the Constitution and the Religious Freedom Restoration Act.
- On December 15, 2020, HHS and the Office of Inspector General (OIG) issued a proposed rule entitled, Solicitation of New Safe Harbors and Special Fraud Alerts. In accordance with section 205 of the Health Insurance Portability and Accountability Act of 1996 (HIPAA), this annual notification solicits proposals and recommendations for developing new, or modifying existing, safe harbor provisions under section 1128B(b) of the Social Security Act (the Act), the Federal anti-kickback statute, as well as developing new OIG Special Fraud Alerts.
- On December 16, 2020, the Food and Drug Administration (FDA) issued guidance entitled, Controlled Correspondence Related to Generic Drug Development. This guidance provides information regarding the process by which generic drug manufacturers and related industry can submit controlled correspondence to FDA requesting information related to generic drug development and the Agency's process for providing communications related to such correspondence. This guidance also describes the process by which generic drug manufacturers and related industry can submit requests to clarify ambiguities in FDA's controlled correspondence response and the Agency's process for responding to those requests.
- On December 16, 2020, FDA issued guidance entitled, Interacting with the Food and Drug Administration on Complex Innovative Trial Designs for Drugs and Biological Products. This guidance provides recommendations to sponsors and applicants on interacting with FDA on complex innovative trial design (CID) proposals for drugs or biological products. FDA is issuing this guidance to satisfy, in part, a mandate under the 21st Century Cures Act (Cures Act). In accordance with the Cures Act mandate, this guidance discusses the use of novel trial designs in the development and regulatory review of drugs and biological products, how sponsors may obtain feedback on technical issues related to modeling and simulation, and the types of quantitative and qualitative information that should be submitted for review.
- On December 17, 2020, FDA issued guidance entitled, Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion. This guidance is intended to provide blood collection establishments and transfusion services with recommendations to control the risk of bacterial contamination of room temperature stored platelets intended for transfusion. The recommendations in this guidance apply to all platelet products stored at room temperature in plasma or additive solutions, including platelets manufactured by automated methods (apheresis platelets), and Whole Blood derived (WBD) single and pooled (pre-storage and post-storage) platelets. Additionally, this guidance provides licensed blood establishments with recommendations on how to report implementation of manufacturing and labeling changes under Title 21 of the Code of Federal Regulations (CFR) 601.12.
Event Notices
- January 7, 2021: CMS announced a public meeting entitled, Town Hall Meeting on Merit-based Incentive Payment System (MIPS) Value Pathway (MVP) Implementation. This notice announces a virtual Town Hall meeting for CMS to share updates on the Merit-based Incentive Payment System (MIPS) Value Pathway (MVP) policy considerations and for stakeholders to provide feedback on those MVP considerations for future implementation. Clinicians, professional organizations, third party vendors, stakeholders, and other interested parties are invited to this meeting to present their individual views on MVP design and implementation.
- January 19, 2021: The National Institutes of Health (NIH) announced a public meeting entitled, Meeting of the National Advisory Council for Biomedical Imaging and Bioengineering. The purpose of the meeting is for the Institute Director and other Institute staff to present their report.
- February 2, 2021: FDA announced a public meeting entitled, Scientific and Ethical Considerations for the Inclusion of Pregnant Women in Clinical Trials. The meeting is intended to gather industry, patient, clinician, researcher, institutional review board, ethicist, professional society and other stakeholder input on the scientific and ethical issues that surround the inclusion of pregnant women in clinical trials for drug development.
- February 2, 2021: NIH announced a public meeting entitled, Meeting of the National Advisory Child Health and Human Development Council. The agenda will include opening remarks, administrative matters, Director’s Report, Division of Extramural Research Report, and other business of the Council.
- February 4, 2021: HHS announced a public meeting entitled, Meeting of the National Vaccine Advisory Committee (NVAC). NVAC will hear presentations on vaccine safety, communication activities for COVID-19 vaccines, and immunization equity.
- February 10-11, 2021: HHS announced a public meeting entitled, Meeting of the Presidential Advisory Council on Combatting Antibiotic-Resistant Bacteria (PACCARB). The February 10-11 public meeting will be dedicated to presentations from two new working groups of the PACCARB, one on Inter-Professional Education and another on Antibiotics Access and Use, which were formed in response to a task letter from the Assistant Secretary for Health. The two-day virtual public meeting will also include an update on the impact of COVID-19 on antimicrobial resistance.
- February 11, 2021: NIH announced a public meeting entitled, Meeting of the National Cancer Institute President’s Cancer Panel. The purpose of the meeting is to discuss innovation to increase cancer screening.
II. Congressional Hearings
U.S. Senate
- On December 16, 2020, the Senate Committee on Finance Subcommittee on Health held hearing entitled The Alzheimer’s Crisis: Examining Testing and Treatment Pipelines and Fiscal Implications. The purpose of the hearing was to discuss the current state of research, therapeutics, and diagnostics for Alzheimer’s disease. Witnesses present included: Nikolay Dokholyan, G. Thomas Passananti Professor and Vice Chair for Research, Pennsylvania State College of Medicine; Dr. Randall J. Bateman, Charles F. and Joanne Knight Distinguished Professor of Neurology, Director, Dominantly Inherited Alzheimer’s Network (DIAN), DIAN Trials Unit (DIAN-TU), Washington University School of Medicine; Dr. Richard Mohs, Chief Scientific Officer, Global Alzheimer’s Platform Foundation; and Dr. Maria Carrillo, Chief Science Officer, Alzheimer’s Association.
III. Reports, Studies & Analyses
- On December 14, 2020, the Government Accountability Office (GAO) published a report entitled, Drug Pricing Program: HHS Uses Multiple Mechanisms to Help Ensure Compliance with 340B Requirements. GAO was asked to provide information on the Health Resources and Services Administration’s (HRSA) efforts to oversee covered entities’ compliance with 340B Program requirements. This report describes: (1) the audit findings that HRSA issued to address covered entity noncompliance with 340B Program requirements; and (2) other efforts HRSA uses to help ensure that covered entities comply with 340B Program requirements.
- On December 16, 2020, the Kaiser Family Foundation (KFF) published an issue brief entitled, Health Insurer Financial Performance Through September 2020. This brief analyzes third quarter data from 2018 to 2020 to examine how insurance markets performed financially through the end of September, as the pandemic continued and health care utilization climbed back towards previous levels. The brief uses financial data reported by insurance companies to the National Association of Insurance Commissioners (NAIC) and compiled by Mark Farrah Associates to look at average medical loss ratios and gross margins in the Medicare Advantage, Medicaid managed care, individual (non-group), and fully-insured group (employer) health insurance markets through the third quarter of each year.
IV. Other Health Policy News
- On December 15, 2020, HHS announced that the Centers for Disease Control and Prevention (CDC) will award $140 million for COVID-19 vaccine preparedness and almost $87 million for tracking and testing to 64 jurisdictions, including all 50 states and U.S. territories. More information about this announcement can be found here.
- On December 16, 2020, HHS, through HRSA, announced it has completed review of Phase 3 applications from the Provider Relief Fund (PRF) program and will distribute $24.5 billion to over 70,000 providers. Up from the $20 billion originally planned, the addition of another $4.5 billion in funding is being used to satisfy close to 90 percent of each applicant’s reported lost revenues and net change in expenses caused by the coronavirus pandemic in the first half of 2020. Payment distribution started today and will continue through January 2021. More information about this announcement can be found here.
- On December 17, 2020, HHS announced three ways the federal government will continue supporting SARS-CoV-2 (the virus that causes COVID-19) testing efforts by states and territories, especially for nursing homes, into the first quarter of 2021. First, HHS plans to continue to provide weekly shipments of SARS-CoV-2 sample collection supplies to states and territories through at least March 2021 and likely longer. Second, HHS is collaborating with the General Services Administration (GSA) to provide a streamlined process for states, territories, and other government agencies to purchase point-of-care diagnostic tests, starting with the Abbott BinaxNOW rapid antigen test. Finally, to ensure continued testing support of vulnerable populations, HHS is allocating an additional 30 million Abbott BinaxNOW tests for nursing homes, assisted living facilities, and home health care, hospice organizations, HBCUs, tribes, and other vulnerable groups. This 30 million will continue support to these organizations through approximately March 2021. More information about HHS efforts to support COVID-19 testing can be found here.
- On December 17, 2020, the Center for Medicare & Medicaid Innovation (CMMI) announced a new opportunity to enable Medicaid Managed Care Organizations (MCOs) to better serve enrollees who are dually eligible for Medicare and Medicaid. This new Model opportunity is the first CMS initiative designed to harness the power of Medicaid MCOs to coordinate Medicare and Medicaid services and improve health outcomes for the population of dually eligible beneficiaries who are in both Medicaid managed care and Medicare fee-for-service (FFS). The new opportunity for MCOs to participate in the Global and Professional Options of the Direct Contracting Model seeks to encourage Medicaid MCOs to partner with providers and suppliers and implement care coordination programs that can improve quality and reduce Medicare FFS costs. More information about these new Direct Contracting Model options can be found here.
- On December 18, 2020, HHS issued guidance on how the Health Insurance Portability and Accountability Act of 1996 (HIPAA) permits covered entities and their business associates to use health information exchanges (HIEs) to disclose protected health information (PHI) for the public health activities of a public health authority (PHA). The guidance provides examples relevant to the COVID-19 public health emergency on how HIPAA permits covered entities and their business associates to disclose PHI to an HIE for reporting to a PHA that is engaged in public health activities.
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