Alston & Bird Health Care Week in Review, May 13, 2022

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, HRSA released over $450 million in American Rescue Plan (ARP) Rural payments to 2,200 providers and suppliers. Read more about this action and other news below.

I. Regulations, Notices & Guidance

• On May 9, 2022, the Food and Drug Administration (FDA) issued draft guidance entitled, Benefit-Risk Considerations for Product Quality Assessments; Draft Guidance for Industry; Availability. This guidance describes the benefit-risk principles applied by FDA when conducting product quality-related assessments of chemistry, manufacturing, and controls (CMC) information submitted for FDA assessment as part of original new drug applications (NDAs), original biologics license applications (BLAs), or supplements to such applications, in addition to other information (e.g., inspectional findings) available to FDA during its assessment. This guidance discusses how FDA assesses risks, sources of uncertainty, and possible mitigation strategies for a product quality-related issue and how those considerations inform FDA’s understanding of the potential effect on a product. This guidance also discusses how unresolved product quality issues may be addressed in the context of regulatory decision making. The guidance notes that product quality assessments are also done for abbreviated new drug applications (ANDAs), and it discusses how, in certain rare circumstances, unresolved product quality issues may be addressed when there is an urgent clinical need for an ANDA (e.g., a public health emergency or a pervasive drug shortage).
• On May 11, 2022, the Centers for Disease Control and Prevention (CDC) issued a notice entitled, Solicitation of Nominations for Appointment to CDC’s Advisory Committee to the Director (ACD) Laboratory Workgroup (LW); Amended Notice. Nominees will be selected based on expertise in the fields of public health laboratory science and practice, laboratory quality management, diagnostic regulations, and clinical laboratory testing and research. LW members will serve terms ranging from six months to one year and be required to attend LW meetings approximately 1-2 times per month (virtually or in person), and contribute time between meetings for research, consultation, discussion, and writing assignments.
• On May 12, 2022, the Department of Agriculture’s (USDA) Rural Business-Cooperative Service (RBS) issued a notice of funding availability entitled, Inviting Applications for the Delta Health Care Services (DHCS) Grant Program. This notice announces RBS is accepting fiscal year (FY) 2022 applications for the DHCS grant program. The purpose of this program is to provide financial assistance to address the continued unmet health needs in the Delta Region through cooperation among health care professionals, institutions of higher education, research institutions, and economic development entities in the Delta Region. $3 million is currently available for FY 2022. All funds must support projects located in persistent poverty counties in the Delta Region.
• On May 12, 2022, the Centers for Medicare & Medicaid Services (CMS) issued a notice entitled, Medicare and Medicaid Programs; Quarterly Listing of Program Issuances— January through March 2022. The quarterly notice lists CMS manual instructions, substantive and interpretive regulations, and other Federal Register notices that were published from January through March 2022, relating to the Medicare and Medicaid programs and other programs administered by CMS.
• On May 12, 2022, CMS issued a final rule entitled, Medicaid Program; Reassignment of Medicaid Provider Claims. This final rule reinterprets the scope of the general requirement that State payments for Medicaid services under a state plan must generally be made directly to the individual practitioner or institution providing services or to the beneficiary, in the case of a class of practitioners for which the Medicaid program is the primary source of revenue. Specifically, this final rule explicitly authorizes States to make payments to third parties on behalf of individual practitioners, for individual practitioners’ health insurance and welfare benefits, skills training, and other benefits customary for employees, if the individual practitioner consents to such payments on their behalf.
• On May 13, 2022, CDC issued draft guidance with request for comment entitled, Draft National Institute for Occupational Safety and Health (NIOSH) Healthcare Personal Protective Technology (PPT) Targets for 2020 to 2030; Request for Comment. This notice is in response to the National Institute for Occupational Safety and Health (NIOSH) recognizing a growing need for its unique capabilities related to personal protective technology (PPT) research, development, performance standards and test methods, and conformity assessment related to infectious diseases and non-infectious hazards. In response to this growing need, NIOSH established Draft Healthcare PPT Targets for 2020 to 2030.
• On May 13, 2022, FDA issued a final rule entitled, Microbiology Devices; Reclassification of Human Immunodeficiency Virus Serological Diagnostic and Supplemental Tests and Human Immunodeficiency Virus Nucleic Acid Diagnostic and Supplemental Tests. FDA is issuing a final rule to reclassify certain human immunodeficiency virus (HIV) serological diagnostic and supplemental tests and HIV nucleic acid (NAT) diagnostic and supplemental tests, post-amendments class III devices with the product code MZF, into class II (special controls), subject to premarket notification. Through this final order, FDA is also adding two new device classification regulations and identifying special controls that FDA believes are necessary to provide a reasonable assurance of safety and effectiveness for these device types. This final order will reduce the regulatory burdens associated with these device types, as manufacturers will no longer be required to submit a premarket approval application (PMA) but can instead submit a premarket notification (510(k)) and receive clearance before marketing their device.

Event Notices

• June 7, 2022: FDA announced a public meeting to discuss the financial transparency and efficiency of the Prescription Drug User Fee Act, Biosimilar User Fee Act, and Generic Drug User Fee Amendments. The meeting will include presentations from FDA on topics related to the financial management of certain user fee programs, including presentations on the following: (1) the 5- year financial plan for the Prescription Drug User Fee Act (PDUFA) VI, Biosimilar User Fee Act (BsUFA) II, and Generic Drug User Fee Amendments (GDUFA) II and (2) the Agency’s progress in implementing resource capacity planning and modernized time reporting.
• June 9-10, 2022: The National Institutes of Health (NIH) announced a public meeting of the Advisory Committee to the Director (ACD). The agenda will include the NIH Acting Director’s Report, updates on ARPA-H and COVID-19, ACD Working Group updates, as well as discussion of the Diversity, Equity, Inclusion and Accessibility (DEIA) Strategic Plan.
• June 14, 2022: The Substance Abuse and Mental Health Services Administration (SAMHSA) announced a public meeting of the Advisory Committee for Women’s Services (ACWS). The meeting will include discussions on assessing SAMHSA’s current strategies, including the mental health and substance use needs of the women and girls’ population. Additionally, ACWS will be addressing priorities regarding the impact of COVID-19 on the behavioral health needs of women and children and directions around behavioral health services and access for women and children.
• June 14-15, 2022: NIH announced a public meeting of the National Advisory Child Health and Human Development Council. The agenda will include opening remarks, administrative matters, the National Institute of Child Health and Human Development (NICHD) Directors’ report, and a discussion of a proposed organizational change to the Division of Extramural Activities and Division of Extramural Research, Grant Applications and/or Proposals. This meeting will include a public discussion of the Institute’s proposal to reorganize its Division of Extramural Activities and Division of Extramural Research. The proposal would simplify the organizational structure of the NICHD, create new organizational components to reduce ‘siloing’, increase administrative efficiencies, facilitate transdisciplinary research and idea exchange, and benefit the institute’s internal and external communities.
• June 15, 2022: CDC announced a public meeting of the Advisory Board on Radiation and Worker Health (ABRWH). The agenda will include discussions on the following: Work Group and Subcommittee Reports; Update on the Status of SEC Petitions; and plans for the August 2022 Advisory Board Meeting.
• June 16, 2022: NIH announced a public meeting of the Diabetes Mellitus Interagency Coordinating Committee Meeting. The meeting’s discussion topic will be, “National Clinical Care Commission Report Perspectives from Federal Partners to Prevent and Control Diabetes and its Complications.”
• June 21-22, 2022: CDC announced a public meeting of the Advisory Council for the Elimination of Tuberculosis. The agenda will include discussions on NIH-funded clinical trials, domestic pediatric tuberculosis, immigration and tuberculosis, and considerations for bringing new tuberculosis drugs to market.
• June 22-23, 2022: CDC announced a public meeting of the Advisory Committee on Immunization Practices (ACIP). The agenda will include discussions on influenza vaccines; pneumococcal vaccine; human papillomavirus vaccine; measles, mumps, rubella (MMR) vaccine; respiratory syncytial virus vaccine; rotavirus vaccine; and Chikungunya vaccine. Recommendation votes on influenza vaccines, pneumococcal vaccine, and MMR vaccine are scheduled.
• June 23, 2022: NIH announced a public meeting of the Office of AIDS Research (OAR) Advisory Council (OARAC). The agenda will include the OAR Director’s Report; updates from the Clinical Guidelines Working Groups of OARAC; updates from NIH HIV-related advisory councils; presentation and discussions on Data Science, and NIH-wide programs and initiatives; and public comment.
• June 27, 2022: CDC announced a public meeting of the NIOSH Fire Fighter Fatality Investigation and Prevention Program (FFFIPP). NIOSH will provide a brief presentation and will facilitate discussion on the following two topics: 1) the primary audiences for NIOSH line-of-duty death investigation reports and the strengths and weaknesses of those reports, including report content, format, and length; and 2) specific feedback on how the NIOSH FFFIPP prioritization guideline for planning investigations can be enhanced to meet the needs of the fire service community.

II. Congressional Hearings

U.S. House of Representatives

• On May 11, 2022, the House Committee on Appropriations Subcommittee on Departments of Labor, Health and Human Services, Education, and Related Agencies held a hearing entitled, Fiscal Year (FY) 2023 Budget Request for the National Institutes of Health. Witnesses present included: Dr. Diana Bianchi, Director, Eunice Kennedy Shriver National Institute of Child Health and Human Development; Dr. Anthony S. Fauci, Director, National Institute of Allergy and Infectious Diseases; Dr. Gary H. Gibbons, Director, National Heart, Lung, and Blood Institute; Dr. Douglas R. Lowy, Acting Director, National Cancer Institute; Dr. Lawrence A. Tabak, Acting Director, National Institutes of Health; and Dr. Nora D. Volkow, Director, National Institute on Drug Abuse.
• On May 11, 2022, the House Committee on Appropriations Subcommittee on Commerce, Justice, Science, and Related Agencies held a hearing entitled, FY 2023 Budget Request for the National Science Foundation. Witnesses present included: The Honorable Sethuraman Panchanathan, Director, National Science Foundation.
• On May 11, 2022, the House Committee on Energy & Commerce Subcommittee on Health held a markup of six bills. Legislation discussed included: H.R. 7667, the Food and Drug Amendments of 2022, H.R. 7666, the Restoring Hope for Mental Health and Well-Being Act of 2022, H.R. 7233, the Keeping Incarceration Discharges Streamlined for Child and Accommodating Resources in Education (KIDS CARES) Act, H.R. 623, the Gabriella Miller Kids First Research Act 2.0, H.R. 3771, the South Asian Heart Health Awareness Act of 2021, and H.R. 5585, the Advanced Research Project Agency-Health (ARPA-H) Act. All six bills were ordered reported favorably to the full Committee.
• On May 12, 2022, the House Committee on Appropriations Subcommittee on Departments of Labor, Health and Human Services, Education, and Related Agencies held a hearing entitled, Healthy Aging: Maximizing the Independence, Well-being, and Health of Older Adults. Witnesses present included: Robert B. Blancato, National Coordinator, Elder Justice Coalition; Patricia Lyons, President and CEO, Senior Citizens, Inc.; Karen Orsi, Director, Oklahoma Mental Health and Aging Coalition; and Dr. Martha B. Pelaez, Board Member, National Council on Aging and Evidence-Based Leadership Collaborative.
• On May 12, 2022, the House Committee on Homeland Security Subcommittee on Border Security, Facilitation, and Operations held a hearing entitled, Examining the Department of Homeland Security’s (DHS) Efforts to Combat the Opioid Epidemic. Witnesses present included: Mr. Brian Sulc, Executive Director, Transnational Organized Crime Mission Center, Office of Intelligence & Analysis, U.S. Department of Homeland Security; Mr. Pete Flores, Executive Assistant Commissioner, Office of Field Operations, U.S. Customs & Border Protection, U.S. Department of Homeland Security; and Mr. Steve Cagan, Assistant Director for Countering Transnational Organized Crime, Homeland Security Investigations, U.S. Immigration & Customs Enforcement, U.S. Department of Homeland Security.

U.S. Senate

• On May 11, 2022, the Senate Committee on Appropriations Subcommittee on Interior, Environment, and Related Agencies held a hearing entitled, A Review of the FY 2023 President’s Budget for the Indian Health Service. Witnesses present included: The Honorable Elizabeth Fowler, Acting Director, Indian Health Service (IHS).

III. Reports, Studies & Analyses

• On May 10, 2022, the Kaiser Family Foundation (KFF) published an issue brief entitled, Fiscal and Enrollment Implications of Medicaid Continuous Coverage Requirement During and After the PHE Ends. This analysis projects enrollment growth through the end of FY 2022. It examines how much of the enrollment growth can be attributed to baseline, or expected enrollment increases without the pandemic, and how much to the maintenance of eligibility (MOE) continuous enrollment requirement during the Public Health Emergency (PHE). KFF explores the costs tied to MOE enrollment growth, estimates how much fiscal relief was provided to states through the enhanced federal Medicaid match rate (FMAP), and describes scenarios for enrollment going forward.
• On May 10, 2022, KFF published an issue brief entitled, Unwinding the PHE: What We Can Learn From Pre-Pandemic Enrollment Patterns. This brief examines typical enrollment patterns for Medicaid and CHIP and uses 2018 Medicaid claims data to gain insight into the effects of the continuous enrollment requirements by eligibility group to help inform the current policy discussion and better understand the factors that contribute to Medicaid enrollment changes.
• On May 11, 2022, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) published a report entitled, Department of Health and Human Services Met Many Requirements, but It Did Not Fully Comply with the Payment Integrity Information Act of 2019 and Applicable Improper Payment Guidance for the Fiscal Year 2021. The Payment Integrity Information Act of 2019 (PIIA: PL 116-117) was enacted on March 2, 2020 and requires OIGs to review and report on agencies’ annual improper payment information included in their Agency Financial Reports (AFRs) to determine compliance with PIIA.
• On May 12, 2022, HHS OIG published a report entitled, National Background Check Program for Long-Term-Care Providers: An Interim Assessment. This report is the fifth in a series to supplement the mandated evaluation-reviews Idaho and Mississippi, the last two States that are participating in the National Background Check Program. The interim review allows for CMS to assist the States in fully implementing Program requirements during participation.
• On May 12, 2022, HHS OIG published a report entitled, Adverse Events in Hospitals: A Quarter of Medicare Patients Experienced Harm in October 2018. In 2010, OIG reported the first national incidence rate of patient harm events in hospitals—27 percent of hospitalized Medicare patients experienced harm in October 2008. During that month, hospital care associated with these events cost Medicare and patients an estimated $324 million in reimbursement, coinsurance, and deductible payments. Nearly half of these events were preventable. OIG conducted a new study to update the national incidence rate of patient harm events among hospitalized Medicare patients in October 2018. This work included calculating a new rate of preventable events and updating the cost of patient harm to the Medicare program.
• On May 12, 2022, the Government Accountability Office (GAO) published a report entitled, FDA Took Steps to Help Make Tests Available; Policy for Future Public Health Emergencies Needed. This report examines, among other things, 1) the actions FDA took to help make COVID-19 tests available for use, 2) the number of tests FDA authorized and those for which it exercised enforcement discretion, and 3) FDA's monitoring of these tests after they were available for use. GAO reviewed agency documentation and interviewed FDA and associations that represent test developers.
• On May 12, 2022, KFF published a report entitled, Most Office-Based Physicians Accept New Patients, Including Patients with Medicare and Private Insurance. This brief builds on and updates previous KFF analyses by drawing on the 2019 National Electronic Health Records Survey (NEHRS) to examine: 1) the share of non-pediatric office-based physicians accepting new patients with Medicare or private insurance and how these rates have changed over time; and 2) the share of physicians accepting new patients by physician specialties, geographic areas, and physician and practice characteristics across Medicare and private insurance.

IV. Other Health Policy News

• On May 9, 2022, IHS announced $5 million to target resources directly to tribes, tribal organizations, urban Indian organizations, and IHS direct service facilities to address Alzheimer’s disease within tribal communities. This funding will support tribes, tribal organizations, and urban Indian organizations to develop comprehensive and sustainable approaches to addressing Alzheimer’s disease and other causes of dementia, focusing on awareness, recognition, diagnosis, assessment, management, and support for caregivers. More information on this funding can be found here.
• On May 10, 2022, HHS announced it had awarded $16.3 million in grant funding to support 31 grantees to enhance and expand the telehealth infrastructure and capacity of Title X family planning clinics in 26 states, one U.S. territory, and one freely associated state. HHS used funds made available through the American Rescue Plan (ARP) Act to award these grants to current Title X family planning grantees for a 12-month project period starting on May 15, 2022. More information on this funding can be found here.
• On May 10, 2022, the Health Resources and Services Administration (HRSA) released over $450 million in American Rescue Plan (ARP) Rural payments to 2,200 providers and suppliers who served rural Medicaid, Children's Health Insurance Program (CHIP), and Medicare beneficiaries from January 1, 2019 through September 30, 2020. With the announcement, a total of $7.9 billion ARP Rural payments has now been distributed to more than 46,000 providers in all 50 states, Washington D.C., and five territories. This is in addition to HRSA’s distribution of Provider Relief Fund Phase 4 payments totaling nearly $13.5 billion in funding to approximately 86,000 providers since November 2021. More information on this funding can be found here.
• On May 11, 2022, HHS announced the availability of $5 million for community health centers, funded by HRSA, to increase equitable access to life-saving cancer screenings. This funding supports President Biden’s Unity Agenda and his call to action on cancer screening and early detection as part of the Administration’s Cancer Moonshot initiative. In addition to helping health centers address and remove barriers to care, this funding will help increase the number of health center patients screened for cervical, breast, and colorectal cancer. Also, with support from National Cancer Institute-Designated Cancer Center partners, this funding will help ensure that health center patients have hands-on assistance accessing high quality cancer care and treatment if needed. More information on this funding can be found here.
• On May 12, 2022, the Biden Administration announced that it had licensed, through NIH, 11 COVID-19 research tools and early-stage vaccine and diagnostic candidates to the Medicines Patent Pool (MPP) through the World Health Organization’s COVID-19 Technology Access Pool (C-TAP). The licenses will allow manufacturers from all around the world to work with MPP and C-TAP to use these technologies for the potential development of COVID-19 vaccines, treatments, and diagnostics to benefit people living in low- and middle-income countries. Included in the technologies licensed is the SARS-CoV-2 stabilized spike protein—a patented invention included in multiple COVID-19 vaccines. More information on this action can be found here.
• On May 12, 2022, CMS issued guidance on Medicaid and CHIP coverage and payment for “stand-alone vaccine counseling.” CMS interprets the Medicaid Early and Periodic Screening, Diagnostic, and Treatment (EPSDT) benefit to require states to provide coverage of stand-alone vaccine counseling to Medicaid under the age of 21 who are eligible for EPSDT. This interpretation applies to stand-alone vaccine counseling related to all vaccines covered for beneficiaries eligible for EPSDT. More information on this guidance can be found here.

Click here to view the members of our Health Care Legislative & Public Policy team.