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 issued an advisory highlighting the need to address the health worker burnout crisis and announced ARPA-H as an independent agency within NIH. Read more about these actions and other news below.
I. Regulations, Notices & Guidance
- On May 23, 2022, the Food and Drug Administration (FDA) issued draft guidance entitled, Antibacterial Therapies for Patients With an Unmet Medical Need for the Treatment of Serious Bacterial Diseases--Questions and Answers (Revision 1); Draft Guidance for Industry; Availability. The purpose of this draft guidance is to assist sponsors in the clinical development of new antibacterial drugs and provide updates to the options for development programs, given the availability of new therapeutic options.
- On May 23, 2022, FDA issued draft guidance entitled, Blood Pressure and Pulse Donor Eligibility Requirements: Compliance Policy; Draft Guidance for Industry; Availability. The draft guidance addresses certain regulatory requirements for determining donor eligibility that apply to blood establishments that collect blood and blood components for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.
- On May 23, 2022, the Executive Office of the President (EOP) issued a memorandum to the Department of Health and Human Services (HHS) entitled, Delegating Authority Under the Defense Production Act to Ensure an Adequate Supply of Infant Formula. The notice gives HHS the authority to determine, in consultation with heads of relevant executive departments and agencies, the proper nationwide priorities and allocation of all ingredients necessary to manufacture infant formula, including controlling the distribution of such materials (including applicable services) in the civilian market, for responding to the shortage of infant formula within the U.S.
- On May 23, 2022, FDA issued final guidance entitled, Recommendations to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Components; Guidance for Industry; Availability. The guidance document provides blood establishments that collect blood and blood components with recommendations intended to reduce the possible risk of transmission of Creutzfeldt-Jakob disease (CJD) and variant Creutzfeldt-Jakob disease (vCJD) by blood and blood components. The recommendations in the guidance apply to the collection of Whole Blood and blood components intended for transfusion or for use in further manufacturing, including Source Plasma. The guidance removes the recommendations to defer indefinitely blood donors for geographic risk of possible exposure to bovine spongiform encephalopathy for time spent in the United Kingdom (U.K.) from 1980 to 1996 and for time spent in France and Ireland from 1980 to 2001, and receipt of a blood transfusion in the U.K., France, and Ireland from 1980 to the present. The guidance also provides recommendations for requalification of individuals previously deferred for these geographic risk factors, provided they meet all other eligibility requirements.
- On May 23, 2022, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule entitled, Basic Health Program; Federal Funding Methodology for Program Year 2023 and Proposed Changes to Basic Health Program Regulations. This document proposes the methodology and data sources necessary to determine Federal payment amounts to be made for program year 2023 to states that elect to establish a Basic Health Program under the Patient Protection and Affordable Care (PPACA) Act to offer health benefits coverage to low-income individuals otherwise eligible to purchase coverage through Health Insurance Exchanges.
- On May 24, 2022, the Administration for Community Living (ACL) issued a notice entitled, Availability of Program Application Instructions for Long-Term Care Ombudsman Program Funds. The purpose of this funding opportunity for State Long-Term Care Ombudsman Programs is to enhance their capacity to respond to and resolve complaints about abuse and neglect, especially in board and care facilities and similar adult care homes, including assisted living facilities. These funds will allow Ombudsman programs to develop capacity through activities such as hiring staff and recruiting and training volunteers to conduct visits and investigate complaints, develop resident and family councils, and provide information and assistance and education on resident rights and prevention of abuse and neglect.
- On May 24, 2022, the Centers for Disease Control and Prevention (CDC) issued a notice entitled, Draft Guidelines for Examining Unusual Patterns of Cancer and Environmental Concerns. CDC is opening a public docket to obtain comment on the Draft Guidelines for Examining Unusual Patterns of Cancer and Environmental Concerns (2022 Draft Guidelines). The 2022 Draft Guidelines provide updates to the 2013 publication, Investigating Suspected Cancer Clusters and Responding to Community Concerns: Guidelines from the CDC and the Council of State and Territorial Epidemiologists (CSTE) (2013 Guidelines). The updates provide state, tribal, local, and territorial health departments guidance for a revised and expanded approach to evaluating concerns about unusual patterns of cancer in communities, including those associated with local environmental concerns.
- On May 25, 2022, FDA issued final guidance entitled, Importation of Prescription Drugs Final Rule Questions and Answers; Guidance for Industry: Small Entity Compliance Guide; Availability. The guidance is intended to help small entities comply with the final rule entitled, Importation of Prescription Drugs. The final rule was issued to implement a provision of the Federal Food, Drug, and Cosmetic Act (FD&C Act) to allow importation of certain prescription drugs from Canada.
- On May 25, 2022, HHS issued a notice entitled, Establishment of the Advanced Research Projects Agency for Health. The purpose of this announcement is the establishment of the Advanced Research Projects Agency for Health (ARPA-H). The notice also details changes to the organization, functions, and delegations of authority of the National Institutes of Health (NIH), which will house ARPA-H.
- On May 26, 2022, FDA issued final guidance entitled, Advanced Prostate Cancer: Developing Gonadotropin-Releasing Hormone Analogues; Guidance for Industry; Availability. This guidance describes FDA’s current recommendations regarding the overall development program and clinical trial designs for developing gonadotropin-releasing hormone (GnRH) analogues to treat advanced prostate cancer.
- On May 26, 2022, HHS issued the withdrawal of a final rule entitled, Withdrawing Rule on Securing Updated and Necessary Statutory Evaluations Timely. The Securing Updated and Necessary Statutory Evaluations Timely (SUNSET) final rule was originally scheduled to take effect on March 22, 2021. However, after a lawsuit was filed on March 9, 2021, seeking to overturn the SUNSET final rule, HHS extended the effective date of the SUNSET final rule until September 22, 2022. HHS is now withdrawing the SUNSET final rule.
- June 7, 2022: FDA announced a public meeting of the Vaccines and Related Biological Products Advisory Committee (VRBPAC). This meeting will be held to discuss an Emergency Use Authorization (EUA) request by Novavax for a vaccine to prevent COVID-19 in individuals 18 years of age and older.
- June 9, 2022: CDC announced a public meeting of the National Committee on Vital and Health Statistics (NCVHS). The agenda will include stakeholder discussion of potential actions drafted for consideration by the NCVHS Subcommittee on Standards.
- June 13, 2022: NIH announced a public meeting of the National Cancer Advisory Board (NCAB) and the National Cancer Institute (NCI) Board of Scientific Advisors. The agenda will include NCAB subcommittee meetings, a joint meeting of NCAB and NCI Board of Scientific Advisors, and a report and presentation from the NCI Acting Director.
- June 14-15, 2022: FDA announced a public meeting of VRBPAC. This two-day virtual meeting will be held to discuss recent requests to amend the EUA of the Moderna COVID-19 mRNA vaccine to include the administration of a primary vaccine series to infants, children, and adolescents six months through 17 years of age and to amend the EUA of the Pfizer-BioNTech COVID-19 mRNA vaccine to include the administration of a primary series to infants and children six months through four years of age.
- June 14-15, 2022: The Health Resources and Services Administration (HRSA) announced a public meeting of the Advisory Committee on Infant and Maternal Mortality (ACIMM). The agenda may include discussion of the following topics: federal program updates; sudden infant death syndrome (SIDS) and sudden unexpected infant death (SUID); violence, incarceration, and substance abuse; cultural strength and resilience; American Indian/Alaskan Native maternal and infant health disparities; workforce and workforce development; and race concordant care.
- June 27, 2022: NIH announced a public meeting of the Frederick National Laboratory Advisory Committee to NCI. The agenda will include a discussion of the ongoing and new activities of the Frederick National Laboratory for Cancer Research.
- June 28, 2022: FDA announced a public meeting of VRBPAC. The committee will meet in open session to discuss whether and how the SARS-CoV-2 strain composition of COVID-19 vaccines should be modified.
- June 29-30, 2022: FDA announced a public meeting of the Cellular, Tissue, and Gene Therapies Advisory Committee. Matters considered at the meeting will include discussion of the current regulatory expectations for xenotransplantation products. The discussion topics include human cells that have had ex vivo contact with animal cells, and animal organs and cells for transplantation into human subjects, both of which are xenotransplantation products.
- July 28-29, 2022: FDA announced a public meeting of the General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee. The agenda will include discussion of skin lesion analyzer technology and its application to detecting skin cancers in various patient care settings, as well as the possible reclassification of approved computer-aided melanoma detection class III devices.
II. Congressional Hearings
U.S. House of Representatives
- On May 25, 2022, the House Committee on Energy and Commerce Subcommittee on Oversight and Investigations held a hearing entitled, Formula Safety and Supply: Protecting the Health of America’s Babies. Witnesses present included: Hon. Robert M. Califf, M.D., Commissioner, FDA; Frank Yiannas, M.P.H., Deputy Commissioner, Food Policy and Response, FDA; Susan Mayne, Ph.D., Director, Center for Food Safety and Applied Nutrition, FDA; Christopher J. Calamari, President, US and Canada Nutrition; and Senior Vice President, Abbott; Scott Fitz, Vice President, Technical & Production, Gerber Products Company; and Robert Cleveland, Senior Vice President, Nutrition, North America and Europe, Reckitt.
- On May 25, 2022, the House Committee on Appropriations Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies held a hearing entitled, The Infant Formula Crisis. Witnesses present included: Ginger Carney, Director of Clinical Nutrition, St. Jude Children’s Research Hospital; Sarah Chamberlin, Executive Director, National PKU News; Michael Gay, Owner and Manager, Food Fresh; and Brian Ronholm, Director of Food Policy, Consumer Reports.
- On May 25, 2022, the Senate Committee on Indian Affairs held a nomination hearing entitled, Nomination Hearing to consider Roselyn Tso to be Director of the Indian Health Service, Department of Health and Human Services. Witnesses present included: Roselyn Tso, Director, Indian Health Service (IHS).
- On May 26, 2022, the Senate Committee on Health, Education, Labor, and Pensions held a hearing entitled, Infant Formula Crisis: Addressing the Shortage and Getting Formula on Shelves. Witnesses present included: the Honorable Robert Califf, M.D., Commissioner, FDA.
III. Reports, Studies & Analyses
- On May 23, 2022, the Government Accountability Office (GAO) published a report entitled, Prevalence of and Efforts to Screen and Treat Mental Health Conditions in Prenatal and Postpartum TRICARE Beneficiaries. This report describes the prevalence of perinatal mental health conditions in the TRICARE population; and the Department of Defense’s (DOD) efforts to screen and treat such conditions. GAO analyzed TRICARE data for pregnancy outcomes (live deliveries and losses) in fiscal years 2017 through 2019, to identify (1) mental health diagnoses during pregnancy or up to 1 year after, and (2) mental health-related prescriptions dispensed and psychological services.
- On May 24, 2022, Alston & Bird published a report entitled, Healthy Byte: OCR Seeks Comment on Recognized Security Practices, Penalties, and HIPAA Settlement Sharing. In this Healthy Byte, Alston & Bird’s Alysa Austin and Lance Taubin discussed HHS’ Office of Civil Rights (OCR) expectations for implementing recognized security practices, the steps covered entities should be taking now, what should constitute a compensable “harm,” and payment methodologies to determine settlement sharing.
- On May 25, 2022, the Congressional Budget Office (CBO) published a report entitled, The Budget and Economic Outlook: 2022 to 2032. The report presents CBO’s baseline projections of what the federal budget and the economy would look like in the current year and over the next 10 years if current laws governing taxes and spending generally remained unchanged. Notably, the report includes projections based on the current COVID-19 public health emergency (PHE) lasting until July 2023. The report also projects that the Medicare Hospital Insurance (HI) Trust Fund will be exhausted in 2030.
- On May 27, 2022, the Kaiser Family Foundation (KFF) published a report entitled, Health Care Disparities Among Asian, Native Hawaiian, and Other Pacific Islander (NHOPI) People. This report uses 2019 American Community Survey (ACS) data to examine how demographic characteristics as well as measures of health coverage and other social and economic factors that drive health and health care vary for Asian and NHOPI people overall and by subgroups.
- On May 27, 2022, Alston & Bird published a report entitled, Healthy Byte: How Does a Recent OIG Advisory Opinion Support Providers Seeking to Expand Telehealth Services? In this Healthy Byte, Alston & Bird’s Sean Sullivan and CJ Frisina discuss the fraud and abuse implications of providing free smartphones to patients, including key safeguards and how the COVID-19 public health emergency and telehealth reimbursement impacted the analysis. This discussion is in response to a favorable advisory opinion from HHS OIG, where OIG reviewed an arrangement that featured a provider giving free smartphones to existing patients to access telehealth services.
IV. Other Health Policy News
- On May 23, 2022, U.S. Surgeon General Dr. Vivek Murthy issued a Surgeon General’s Advisory highlighting the urgent need to address the health worker burnout crisis across the country. Health workers, including physicians, nurses, community and public health workers, nurse aides, among others, have faced systemic challenges in the health care system even before the COVID-19 pandemic, leading to crisis levels of burnout. There is a projected shortage of more than three million essential low-wage health workers in the next five years and a projected shortage of nearly 140,000 physicians by 2033. More information on this action can be found here and here.
- On May 25, 2022, CMS approved California, Florida, Kentucky, and Oregon’s actions to expand Medicaid and CHIP coverage to 12 months postpartum for a total of an additional 126,000 families across their states. The expansion of coverage in California, Kentucky, and Oregon was made possible by a new state plan opportunity included in the American Rescue Plan (ARP) Act. Florida will offer its coverage through a Medicaid and CHIP section 1115 demonstration. California, Florida, Kentucky, and Oregon join South Carolina, Tennessee, Michigan, Louisiana, Virginia, New Jersey, and Illinois in extending Medicaid and CHIP coverage from 60 days to 12 months postpartum. More information on this action can be found here.
- On May 25, 2022, HHS Secretary Xavier Becerra announced the formal establishment of ARPA-H as an independent entity within NIH and the appointment of Adam H. Russell, D.Phil., as the agency’s acting deputy director. Currently, Dr. Russell is the Chief Scientist at University of Maryland's Applied Research Laboratory for Intelligence and Security (ARLIS). He will begin his role as acting deputy director in June. More information on this action can be found here.
- On May 27, 2022, HHS announced that Medicare Part B premiums paid by Medicare beneficiaries for 2022 should be adjusted downward to account for an overestimate in costs attributable to the inclusion of new Alzheimer's drug Aduhelm within the Medicare program for reimbursement. Due to the legal and operational hurdles in adjusting Medicare premiums midstream in 2022, the reduction in premium costs attributable to Aduhelm will be incorporated into Medicare premiums for 2023 to lower Part B premiums paid by Medicare beneficiaries. The decision to lower premium payments came after CMS released a report that concluded that cost savings from lower-than-expected Medicare Part B spending on Aduhelm can be passed along to Medicare beneficiaries by lowering the 2023 Part B premium. More information on the HHS announcement and CMS report can be found here and here.
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