Health Care Week in Review: President’s Budget and ASPR Cybersecurity Guide

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, President Biden unveiled his FY 2024 Budget, and ASPR released a cybersecurity implementation guide for health care organizations. Read more about these actions and other news below.

I. Regulations, Notices & Guidance

• On March 6, 2023, the Food and Drug Administration (FDA) issued a final rule entitled, Guidance for Industry: Labeling of Infant Formula. FDA is publishing this reminder to infant formula manufacturers and distributors about certain labeling requirements for infant formula products. While this guidance provides information about the labeling requirements for infant formula products generally, FDA is concerned particularly about the number of infant formula products that bear the same or similar statements of identity but are different in composition or intended use. FDA has also noticed an increased use of nutrient content claims that render products misbranded under the Federal Food, Drug, and Cosmetic Act (FD&C Act). This guidance provides information that can help infant formula manufacturers and distributors understand and comply with relevant labeling requirements.
• On March 7, 2023, the Health Resources and Services Administration (HRSA) issued a notice entitled, Solicitation of Nominations for Membership to serve on the National Advisory Council on Migrant Health. HRSA is seeking nominations of qualified candidates for consideration for appointment as members of the National Advisory Council on Migrant Health (NACMH). NACMH advises, consults with, and makes recommendations to the Secretary of the Department of Health and Human Services (HHS) concerning the organization, operation, selection, and funding of migrant health centers (MHCs) and other entities, under grants and contracts under the Public Health Service (PHS) Act. HRSA is seeking nominations to fill two positions on NACMH and will accept written nominations for NACMH membership on a continuous basis.
• On March 8, 2023, the Agency for Healthcare Research and Quality (AHRQ) published a notice entitled, Supplemental Evidence and Data Request on Genitourinary Syndrome of Menopause. AHRQ is seeking scientific information submissions from the public to inform its review on Genitourinary Syndrome of Menopause, which is currently being conducted by the AHRQ’s Evidence-based Practice Centers (EPC) Program. AHRQ believes access to published and unpublished pertinent scientific information will improve the quality of this review.
• On March 8, 2023, FDA issued a proposed rule entitled, Requirements for Tobacco Product Manufacturing Practice. FDA is proposing to establish tobacco product manufacturing practice requirements for manufacturers of finished and bulk tobacco products. This proposed rule, if finalized, would set forth the requirements with which finished and bulk tobacco product manufacturers must comply in the manufacture, preproduction design validation, packing, and storage of finished and bulk tobacco products, to assure that the public health is protected and that tobacco products are in compliance with chapter IX of the FD&C Act.
• On March 8, 2023, FDA issued a request for comments entitled, Proposed Requirements for Tobacco Product Manufacturing Practice; Public Hearing; Request for Comments. FDA is announcing a public oral hearing entitled “Proposed Requirements for Tobacco Product Manufacturing Practice.” The FD&C Act authorizes FDA to prescribe current good manufacturing practice (cGMP) or hazard analysis and critical control point methodology (HACCP) regulations related to the manufacture, preproduction design validation, packing, and storage of tobacco products to protect public health and ensure compliance with the FD&C Act. In accordance with this provision, FDA is proposing requirements for tobacco product manufacturing practice (TPMP). The FD&C Act further requires FDA to afford an opportunity for an oral hearing on the proposed regulation. FDA is holding this public oral hearing on April 12, 2023 to carry out this statutory mandate and obtain information and views on the proposed TPMP requirements.
• On March 8, 2023, HRSA issued a notice entitled, Freedom of Information Act Predisclosure Notice. This notice informs submitters who reported COVID-19 data in 2020 for the High-Impact Area Distribution that HRSA received a Freedom of Information Act (FOIA) request for data reported to HHS that was used in determining COVID-19 High-Impact Area Distribution payments under the Provider Relief Fund (PRF). Specifically, the request seeks certain information pertaining to providers who did not receive COVID-19 High-Impact Area Distribution payments. This notice seeks input from these providers so that HRSA can respond to the FOIA request.
• On March 9, 2023, FDA issued a final rule entitled, Mammography Quality Standards Act. FDA is issuing this final rule to update the mammography regulations that were issued under the Mammography Quality Standards Act of 1992 (MQSA) and the FD&C Act. FDA is issuing updates to modernize the regulations by incorporating current science and mammography best practices. These updates are intended to improve the delivery of mammography services by strengthening the communication of healthcare information; allowing for more informed decision making by patients and providers (by requiring facilities to provide them with additional health information); helping to ensure the availability of qualified mammography personnel; bolstering the medical outcomes audit to provide feedback to improve mammography interpretations; modernizing technological aspects of the standards; and adding additional tools to deal with noncompliant facilities. The rule is effective September 10, 2024.
• On March 10, 2023, FDA issued guidance entitled, Documents Related to Coronavirus Disease 2019 (COVID-19). On February 9, 2023, the Secretary of HHS renewed the COVID-19 public health emergency (PHE) declaration issued under section 319 of the PHS Act (“PHE declaration”), effective February 11, 2023. The declaration is expected to expire at the end of the day on May 11, 2023. FDA has issued guidance documents to address the circumstances of the PHE and, more generally, COVID-19. Many of those guidance documents are tied to the duration of the PHE declaration. This notice is intended to provide clarity to stakeholders with respect to the guidance documents that will no longer be effective with the expiration of the PHE declaration and the guidances that FDA is revising to continue in effect after the expiration of the PHE declaration.
• On March 10, 2023, FDA issued final guidance entitled, Evaluation of Gastric pH-Dependent Drug Interactions with Acid-Reducing Agents: Study Design, Data Analysis, and Clinical Implications. This guidance focuses on specific recommendations pertinent to pH-dependent drug-drug interaction (DDI) assessment and describes the current recommendations of FDA regarding when clinical DDI studies with acid-reducing agents (ARAs) are needed, design of the clinical studies, interpretation of study results, and options for managing pH-dependent DDIs in patients. This guidance finalizes the draft guidance of the same title issued on December 1, 2020.

Event Notices

• March 21, 2023: The National Institutes of Health (NIH) announced a meeting of the National Cancer Institute (NCI) Board of Scientific Advisors (BSA). The agenda will include a Director’s report; Request for Applications (RFA), Request for Proposals (RFP), and Program Announcement with Receipt (PAR) concept reviews; and scientific presentations.
• March 27, 2023: NIH announced a meeting of the Center for Scientific Review (CSR). The agenda includes discussion to provide advice to the CRS Director on matters related to the planning, execution, conduct, support, review, evaluation, and receipt and referral of grant applications at CSR.
• March 27, 2023: NIH announced a partially open meeting of NCI’s National Cancer Advisory Board (NCAB). The open agenda will include discussions on the NCI Director’s report and other related business. The closed agenda will include a review of ongoing intramural research efforts and the discussion of confidential personnel issues.
• April 17, 2023: FDA announced an advisory committee meeting of the Antimicrobial Drugs Advisory Committee (ADAC). The committee will discuss new drug application (NDA) 216974, for sulbactam-durlobactam for injection, submitted by Entasis Therapeutics, Inc. The Applicant’s proposed indication is for the treatment of infections due to Acinetobacter baumannii-calcoaceticus complex including multidrug-resistant and carbapenem-resistant strains.
• April 19-20, 2023: The Centers for Disease Control and Prevention (CDC) announced a meeting of the Advisory Board on Radiation and Worker Health (ABRWH or the Advisory Board). ABRWH established under the Energy Employees Occupational Illness Compensation Program Act of 2000 to advise the President on policy and technical functions required to implement the compensation program. The agenda will include discussions on the following: program updates from the National Institute for Occupational Safety and Health (NIOSH), Department of Labor (DOL), and Department of Energy (DOE); U.S. Securities and Exchange Commission (SEC) petitions update; procedures review finalization and document approvals; Savannah River Site workgroup update; and a ABRWH work session.
• April 20, 2023: FDA announced a public advisory committee meeting of the Orthopaedic and Rehabilitation Devices Panel (ORDP) of the Medical Devices Advisory Committee (MDAC). The committee will discuss, make recommendations, and vote on clinical information related to the De Novo request for the NUsurface Meniscus Implant sponsored by Active Implants, Inc. The device is a polymeric disc-shaped device implanted in the medial compartment of the knee to distribute load between the distal femur and proximal tibia and is intended to improve pain and function in the medial compartment of a knee in which the medial meniscus has been resected.
• April 21, 2023: CDC announced a meeting of the Board of Scientific Counselors (BSC), NIOSH. BSC, NIOSH provides advice to the Director of NIOSH on research and prevention programs. The agenda for the meeting addresses Per- and Polyfluoroalkyl Substances and Occupational Safety and Health Economics.
• April 25, 2023: The Substance Abuse and Mental Health Services Administration (SAMHSA) announced a meeting of the Center for Substance Abuse Treatment (CSAT) National Advisory Council (NAC). The agenda will include consideration of minutes from the SAMHSA CSAT NAC meeting of August 30, 2022; a discussion with SAMHSA leadership; a discussion on Hepatitis C Elimination; a discussion on recent policy changes impacting substance use disorder care, including sections 1262 and 1263 of the Consolidated Appropriations Act of 2023 (commonly known as the Mainstreaming Addiction Treatment (MAT) and Medication Access and Training Expansion (MATE) Act provisions, respectively); and a discussion on Low Barrier Models for Medication for Opioid Use Disorder (MOUD). The agenda will also include updates on CSAT activities from the Office of the Director (OD); the Division of Pharmacologic Therapies (DPT); the Division of States and Community Systems (DSCS); the Division of Services Improvement (DSI); Office of Program Analysis and Coordination (OPAC); and Office of Performance Analysis and Management (OPAM).
• May 18, 2023: FDA announced a public advisory committee meeting of the Tobacco Products Scientific Advisory Committee (TPSAC). This meeting will be held to discuss and provide an opportunity for recommendations on the Requirements for Tobacco Product Manufacturing Practice (TPMP) proposed rule.
• May 19, 2023: FDA announced a public advisory committee meeting of the Gastrointestinal Drugs Advisory Committee (GDAC). The committee will discuss new drug application (NDA) 212833, obeticholic acid (OCA) 25 mg oral tablets, submitted by Intercept Pharmaceuticals, Inc., for the treatment of pre-cirrhotic liver fibrosis due to nonalcoholic steatohepatitis.

II. Hearings & Markups

U.S. House of Representatives

• On March 7, 2023, the House Permanent Select Committee on Intelligence held a markup of R. 1376, COVID-19 Origins Act of 2023. The bill was passed by voice vote onto the House of Representatives.
• On March 8, 2023, the House Committee on Oversight and Accountability Select Subcommittee on the Coronavirus Pandemic held a hearing entitled, Investigating the Origins of COVID-19. Witnesses present included: Dr. Robert Redfield, M.D., Former Director, CDC; Dr. Jamie Metzl, Ph.D., Senior Fellow, The Atlantic Council; and Mr. Nicholas Wade, Former Science and Health Editor, The New York Times and Former Editor, Science; and Former Editor, Nature.
• On March 8, 2023, the House Energy and Commerce Subcommittee on Health held a markup entitled, A Health Subcommittee Markup of Five Bills. The bills considered were H.R. 501, the “Block, Report, And Suspend Suspicious Shipments Act; H.R. 498, the 9-8-8 Lifeline Cybersecurity Responsibility Act; H.R. 485, the Protecting Health Care for All Patients Act of 2023; H.R. 467, the HALT Fentanyl Act; and H.R. 801, the Securing the Border for Public Health Act of 2023.
• On March 8, 2023, the House Committee on Appropriations Subcommittee on Labor, Health and Human Services, Education, and Related Agencies held a session entitled, Member Day. Witnesses present included: The Honorable Greg Landsman, Member of the House of Representatives.
• On March 10, 2023, the House Committee on Ways and Means held a hearing entitled, Hearing on President Biden’s Fiscal Year 2024 Budget Request with Treasury Secretary Yellen. Witnesses present included: Janet L. Yellen, United States Secretary of the Treasury.

U.S. Senate

• On March 9, 2023, the Senate Special Committee on Aging held a hearing entitled, Uplifting Families, Workers, and Older Adults: Supporting Communities of Care. Witnesses present included: Dr. Kezia Scales, Ph.D., Vice President of Research & Evaluation, Paraprofessional Health Institute (PHI); Dr. Hannah Maxey, Ph.D., M.P.H., Associate Professor of Family Medicine and Director of the Bowen Center for Health Workforce Research and Policy, Indiana University School of Medicine; Ms. Pam Lowy, Executive Director, Great Bay Services; and Ms. Jacinta Burgess, Home Caregiver/Direct Care Worker.

III. Reports, Studies & Analyses

• On March 6, 2023, the Congressional Research Service (CRS) published a report entitled, The Federal Status of Marijuana and the Expanding Policy Gap with States. This report examines the differences in how marijuana is regulated by the federal government versus individual state governments. As a Schedule I controlled substance under the Controlled Substances Act (CSA), the federal government strictly regulates marijuana and prohibits its manufacture, distribution, dispensation, and possession except for stringently approved research purposes. The federal government has also not approved a marketing application for marijuana for the treatment of any condition except for one marijuana-derived drug and three marijuana-related drugs that are available by prescription. On the other hand, states are deviating from the strict federal standards and allow for some cultivation, sale, distribution, and possession of marijuana. State allowance of marijuana for medical and/or recreational violate the CSA. Although state laws do not affect the status of marijuana under federal law, there are many implications of the widening legal and policy gap between state and federal regulation of marijuana. Some implications include: marijuana’s designation as a Schedule I controlled substance, financial and tax issues for marijuana businesses, and federal law’s enforcement ability.
• On March 7, 2023, the Kaiser Family Foundation (KFF) published a fact sheet entitled, The U.S. Government & Gavi, the Vaccine Alliance. This fact sheet describes Gavi, the Vaccine Alliance (Gavi), which is an independent, public-private partnership and multilateral funding mechanism that aims to increase access to immunization in vulnerable countries and communities (e.g., areas with less resources and children). The authors also identify and explore how the U.S. government supports Gavi, noting that the U.S. is one of Gavi’s top government donors (the U.S. contributes nearly $290 million each year and amounts for 13 percent of all cumulative funding Gavi has received through 2022). The U.S. also provides Gavi with technical support from CDC and the United States Agency for International Development (USAID) and holds a seat on the Gavi Board. The authors recognized that the COVID-19 pandemic exacerbated challenges in access to and administration of vaccines and urged the U.S. to carefully consider how to address these issues during future engagement with Gavi.
• On March 7, 2023, KFF published a report entitled, The COVID-19 Pandemic: Insights from Three Years of KFF Polling. The authors shared several findings from KKF’s polls on the COVID-19 pandemic. One, over the pandemic, trust in public health officials has declined, particularly among Republicans. Two, misinformation about COVID-19 is common, particularly due to the polarization of news and the pace of scientific development during the pandemic. Three, racial disparities and gaps in COVID-19 vaccination rates were essentially eliminated over the course of the pandemic. Four, partisanship greatly influenced individual’s willingness to take preventive actions to protect themselves and others from COVID-19, such as wearing masks and getting vaccinated. Five, the pandemic has had a great impact on people’s lives beyond their health, including on their finances, school preparedness, and more.
• On March 9, 2023, the Government Accountability Office (GAO) released a report entitled, Payment Integrity: Additional Coordination Is Needed for Assessing Risks in the Improper Payment Estimation Process for Advance Premium Tax Credits. GAO conducted this study to review advance premium tax credit payment integrity efforts issued under the Affordable Care Act (ACA). These tax credits help certain eligible individuals purchase health coverage plans through the Marketplaces. As such, GAO examined: (1) key control activities selected states and CMS implemented to prevent providing advance premium tax credits to ineligible individuals through state-based marketplaces; and (2) the extent to which CMS developed a reliable methodology to estimate improper payments in the program. GAO found that control activities to prevent providing tax credits to ineligible beneficiaries varied between states and that all of the selected states exercised certain flexibilities in their eligibility-verification processes. However, GAO also found that CMS did not coordinate with the states to conduct a risk assessment to evaluate the likelihood of improper eligibility determinations when exercising these flexibilities. As such, GAO recommended that CMS coordinates with the states to identify any residual risks and support efforts to take additional risk-mitigation strategies when states exercise additional flexibilities in their eligibility-verification processes.
• On March 10, 2023, GAO published a report entitled, Drug Manufacturing: FDA Should Fully Assess Its Efforts to Encourage Innovation. GAO conducted this study to examine FDA’s efforts to support the use of advanced manufacturing for drug development, which are innovative technologies that improve product quality and process performance (e.g., 3D printing of drugs). GAO found that although advanced manufacturing can promote supply chain resiliency, few drugs have been made using advanced manufacturing. Over the COVID-19 pandemic, FDA utilized its industry engagement effort to approve two drugs made using advanced manufacturing technology to treat COVID-19-related complications. However, GAO noted that FDA is unaware of the extent to which its industry engagement efforts encourage adoption of advanced manufacturing. Additionally, GAO found that stakeholders reported that regulatory challenges confounded their ability to understand whether a drug manufactured using advanced manufacturing will be approved. As such, GAO recommended that FDA formally document and finalize performance goals and measures related to its advanced manufacturing program efforts and regularly assess program progress to help FDA make informed program management decisions and to help stakeholders understand the advanced manufacturing review process.

IV. Other Health Policy News

• On March 6, 2023, HHS remembered and celebrated the life of disability rights leader, Judy Heumann. Ms. Heumann was a was a driving force behind key disability rights accomplishments., including the passage of the Rehabilitation Act, the Individuals with Disabilities Education Act, the Americans with Disabilities Act, and the United Nation’s (U.N.'s) adoption of the Convention on the Rights of Persons with Disabilities. Her leadership helped ensure people with disabilities had equal rights and opportunities around the world. See more about HHS’ commemoration of Ms. Heumann here.
• March 6, 2023, HHS Office of Inspector General (OIG) highlighted the legacy of June Gibbs-Brown, the first woman Inspector General (IG) both at HHS-OIG and in the IG community at large, for Women’s History Month. HHS OIG commemorated IG Brown’s service as IG the Department of Interior, the National Aeronautics and Space Administration (NASA), the Department of Defense (DOD), and HHS. At HHS, IG Brown helped ensure the Medicare program was able to guard against and prevent fraud, waste, and abuse. IG Brown also helped instill a commitment to public service and interagency collaboration at HHS OIG, to work-life balance, and to leadership. She inspired many women who followed in her footsteps and pursued federal careers. More information on HHS OIGs’ commemoration of IG Brown can be found here.
• On March 7, 2023, HHS and HRSA awarded $250,000 in emergency funding to Community Action Agency of Columbiana County, a HRSA-funded health center in Ohio to help support emergency response efforts and follow-up care for people affected by the East Palestine train derailment. This funding will support key response activities, including patient and community outreach. Community Action Agency of Columbiana County is providing East Palestine residents with medical, behavioral health, and dental appointments, has deployed mobile medical units to the affected communities, and supports a Health Assessment Clinic that can help answer community members’ medical concerns related to the train derailment. More information on this action can be found here.
• On March 8, 2023, HHS and the Administration for Strategic Preparedness and Response (ASPR), released a cybersecurity implementation guide to help public and private health care actors prevent and respond to cybersecurity incidents. The Cybersecurity Framework Implementation Guide outlines immediate and long-term actions health care organizations can take to assess and improve their cybersecurity practices and risks. Specifically, the implementation guide provides common language to help organizations understand cybersecurity risk management, identifies cost-effective risk management principles and best practices, and discusses how to apply the National Institute of Standards and Technology (NIST) Framework for Improving Critical Infrastructure Cybersecurity specifically for health care organizations. More information on this announcement can be found here.
• On March 8, 2023, the Department of State and HHS were part of a U.S. delegation to a meeting of the Intergovernmental Negotiating Body at the World Health Organization (WHO) to develop a pandemic accord. This accord aims to build capacity; reduce the threat posed by disease with pandemic-potential; enable rapid and more equitable responses; and establish sustainable financing, governance, and accountability to address future pandemics. The accord will also help increase transparency and cooperation among nations to jointly address future pandemic threats. The Intergovernmental Negotiating Body hopes to finalize this accord by May 2024. More information on this announcement can be found here.
• On March 9, 2023, HHS’ Office of Climate Change and Health Equity (OCCHE) announced that the White House-HHS Health Sector Climate Pledge (the Pledge) will accept new signatories on an ongoing basis. The Pledge is a voluntary commitment to reduce emissions and improve climate resilience. Signatories commit to cut their greenhouse gas emissions by 50 percent by 2030 and achieve net zero emissions by 2050. As of 2022, 102 organizations – representing a wide range of stakeholders including 837 hospitals, health centers, suppliers, insurance companies, group purchasing organizations, and pharmaceutical companies – signed the Pledge. The Pledge advances the Biden Administration’s commitment to achieve climate resilience and emissions reduction, especially given that the health care sector accounts for 8.5 percent of all U.S. emissions. More information on this announcement can be found here.
• On March 9, 2023, President Biden traveled to Philadelphia, Pennsylvania to unveil his fiscal year (FY) 2024 annual budget blueprint for Congress. Each year, the Office of Management and Budget (OMB) produces the annual President’s budget, which outlines the President’s priorities and economic initiatives. The President’s Budget includes several health care provisions that aim to lower drug costs, improve public health preparedness and systems, expand access to health care particularly for vulnerable populations (e.g., children and seniors), support the health care workforce, and advance research. Examples of specific health-related budget items include: (1) a legislative proposal to extend the Medicare Trust Fund’s solvency by at least 25 years; (2) $183 billion over ten years to make the enhanced ACA premium tax credits under the Inflation Reduction Act permanent; (3) $995 million for the Strategic National Stockpile (SNS); (4) $100 million for mobile crisis response and $836 million to the 9-8-8 and Behavioral Health Services program; (6) $600 billion over 10 years to support childcare and preschool for low and middle-income families; and (7) $7.8 billion to drive cancer research and treatment. The President’s FY 2024 budget can be found here.

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