Alston & Bird Health Care Week in Review, April 1, 2022

Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in healthcare 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 released his FY 2023 budget request to Congress, including $127.3 billion for HHS. Read more about this action and other news below.

I. Regulations, Notices & Guidance

• On March 28, 2022, the Agency for Healthcare Research and Quality (AHRQ) issued a notice entitled, Supplemental Evidence and Data Request on Postpartum Home Blood Pressure Monitoring, Postpartum Treatment of Hypertensive Disorders of Pregnancy, and Peripartum Magnesium Sulfate Regimens for Preeclampsia With Severe Features. AHRQ is seeking scientific information submissions from the public. Scientific information is being solicited to inform its review on Postpartum Home Blood Pressure Monitoring, Postpartum Treatment of Hypertensive Disorders of Pregnancy, and Peripartum Magnesium Sulfate Regimens for Preeclampsia with Severe Features, which is currently being conducted by the AHRQ’s Evidence-based Practice Centers (EPC) Program.
• On March 28, 2022, the Food and Drug Administration (FDA) issued a notice entitled, Medical Devices: Technical Amendments. FDA is amending its medical device regulations to update mailing address information and to reduce (from three to one) the number of copies of certain documents that need to be submitted to FDA. The rule does not impose any new regulatory requirements on affected parties.
• On March 30, 2022, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule entitled, Medicare Program; FY 2023 Hospice Wage Index and Payment Rate Update and Hospice Quality Reporting Requirements. The proposed rule proposes to establish a permanent mitigation policy to smooth the impact of year-to-year changes in hospice payments related to changes in the hospice wage index. The rule also proposes updates to the hospice wage index, payment rates, and aggregate cap amount for Fiscal Year (FY) 2023.
• On March 31, 2022, CMS issued a proposed rule entitled, Medicare Program; FY 2023 Inpatient Psychiatric Facilities Prospective Payment System – Rate Update and Quality Reporting - Request for Information. The proposed rule would update the prospective payment rates, the outlier threshold, and the wage index for Medicare inpatient hospital services provided by Inpatient Psychiatric Facilities (IPF), which include psychiatric hospitals and excluded psychiatric units of an acute care hospital or critical access hospital. The proposed rule would also establish a permanent mitigation policy to smooth the impact of year-to-year changes in IPF payments related to decreases in the IPF wage index.
• On March 31, 2022, CMS issued a proposed rule entitled, Medicare Program; Inpatient Rehabilitation Facility Prospective Payment System for Federal Fiscal Year 2023 and Updates to the IRF Quality Reporting Program. This rulemaking proposes updating the prospective payment rates for inpatient rehabilitation facilities (IRFs) for Federal fiscal year (FY) 2023. As required by statute, this proposed rule includes the classification and weighting factors for the IRF prospective payment system’s case-mix groups and a description of the methodologies and data used in computing the prospective payment rates for FY 2023.
• On April 1, 2022, the Centers for Disease Control and Prevention (CDC) issued a notice entitled, CDC Recommendations for Hepatitis B Screening and Testing – United States, 2022; Request for Comment. CDC announces the opening of a docket to obtain comment on proposed updated recommendations for hepatitis B virus (HBV) infection screening and testing (Proposed Updated Recommendations), including hepatitis B screening at least once in a lifetime for persons 18 years of age and older, using a three-test panel.

Event Notices

• April 25-26, 2022: The National Institutes of Health (NIH) announced a public meeting of the National Institute of Environmental Health Sciences Board of Scientific Counselors. The agenda will include a meeting overview and Q & A session, as well as a poster session.
• May 10, 2022: NIH announced a public meeting of the National Advisory Council on Alcohol Abuse and Alcoholism. The agenda will include presentations and other business of the Council.
• May 12, 2022: AHRQ announced a public meeting of the National Advisory Council for Healthcare Research and Quality. The agenda will include discussions about AHRQ and the Patient-Centered Outcomes Research (PCOR) Trust Fund and AHRQ’s role in conducting and supporting health services research, analysis and evaluations focused on understanding the effects of healthcare financing policies.
• May 19-20, 2022: NIH announced a public meeting of the National Deafness and other Communication Disorders Advisory Council. The agenda will include staff reports on divisional, programmatical, and special activities.

II. Congressional Hearings

U.S. Senate

• On March 30, 2022, the Senate Committee on Finance held a hearing entitled, Behavioral Health Care When Americans Need It: Ensuring Parity and Care Integration. Witnesses included John Dicken, Director, Health Care, United States Government Accountability Office; Andy Keller, Ph.D., President and CEO, Linda Perryman Evans Presidential Chair, Meadows Mental Health Policy Institute; Anna Ratzliff, MD, Ph.D., Co-Director of the Advancing Integrated Mental Health Solutions (AIMS) Center and Professor; and Reginald D. Williams II, Vice President for International Health Policy and Practice Innovations, Commonwealth Fund.
• On March 30, 2022, the Senate Committee on the Budget held a hearing entitled, The President’s Fiscal Year 2023 Budget Proposal. Witnesses included the Honorable Shalanda D. Young, Director, Office of Management and Budget.

U.S. House of Representatives

• On March 29, 2022, the House Committee on Oversight and Reform held a hearing entitled, Examining Pathways to Universal Health Coverage. Witnesses present included: Ady Barkan, JD, Founder, Be a Hero; Uche Blackstock, MD, Emergency Physician, Founder and Chief Executive Officer, Advancing Health Equity; Sara R. Collins, PhD, Vice President of Health Coverage and Access, The Commonwealth Fund; Jamila Michener, PhD, Associate Professor, Cornell University Department of Government, Co-Director, Cornell University Center for Health Equity; Jeffrey D. Sachs, PhD, Director, Columbia University Center for Sustainable Development, President, United Nations Sustainable Development Solutions Network; and Grace-Marie Turner, President, Galen Institute.
• On March 29, 2022, the House Budget Committee held a hearing entitled, The President’s Fiscal Year 2023 Budget. Witnesses present included: the Honorable Shalanda D. Young, Director, Office of Management and Budget.
• On March 30, 2022, the House Committee on Energy & Commerce Subcommittee on Health held a hearing entitled, FDA User Fee Reauthorization: Ensuring Safe and Effective Medical Devices. Legislation discussed during the hearing included: R. 7084, the “Protecting and Transforming Cyber Health Care Act of 2022” or the “PATCH ACT”, H.R. 7192, the “Diagnostic Device Advisory Committee Act”, and H.R. ____, the “Medical Device User Fee Amendments of 2022”. Witnesses present included: Jeff Shuren, M.D., Director, Centers for Devices and Radiological Health, Food and Drug Administration; Richard J. Kovac, M.D., Q.E. and Sally Russell Professor of Medicine, Indiana University School of Medicine, Chief Medical Officer, American College of Cardiology; Mark Leahy, President & CEO, Medical Device Manufacturers Association; Janet Trunzo, Senior Executive Vice President, Technology and Regulatory Affairs, Advanced Medical Technology Association (AdvaMed); and Diane Wurzburger, Executive of Regulatory Affairs, GE Healthcare.
• On March 30, 2022, the House Committee on Oversight and Reform Select Subcommittee on the Coronavirus Crisis held a hearing entitled, Moving Beyond the Coronavirus Crisis: The Biden Administration’s Progress in Combating the Pandemic and Plan for the Next Phase. Witnesses present included: The Honorable Rochelle Walensky, MD, MPH, Director, Centers for Disease Control and Prevention; Vice Admiral Vivik Murthy, MD, MPH, Unites States Surgeon General, Department of Health and Human Services; and The Honorable Dawn O'Connell, Assistant Secretary for Preparedness and Response, Department of Health and Human Services.
• On March 31, 2022, the House Committee on Appropriations held a hearing entitled, FY 2023 Budget Request for the Department of Health and Human Services. Witnesses present included: The Honorable Xavier Becerra, Secretary, Department of Health and Human Services.

III. Reports, Studies & Analyses

• On March 28, 2022, HHS Office of Inspector General (OIG) published a report entitled, FY 2023 Congressional Budget Justification. OIG’s FY 2023 budget submission includes a total of $453.8 million to oversee HHS programs, including $112.8 million for oversight of HHS’s Public Health and Human Services (PHHS) programs and $341 million for oversight of the Medicare and Medicaid programs, including Health Care Fraud and Abuse Control (HCFAC) Program activities and law enforcement activities coordinated with HHS and the Department of Justice.
• On March 29, 2022, the Congressional Research Service (CRS) published a report entitled, Medicare and Budget Sequestration. This report begins with an overview of budget sequestration and Medicare before discussing how budget sequestration has been implemented across the different parts of the Medicare program.
• On March 30, 2022, the Government Accountability Office (GAO) published a report entitled, Mental Health Care: Consumers with Coverage Face Access Challenges. This report focuses on consumers who have coverage for mental health care and the challenges they encounter despite having that coverage. There have been longstanding concerns in the U.S. about the accessibility of mental health services for these consumers. Although approximately 91 percent of the U.S. population is covered by public or private health plans, having such coverage does not guarantee access to mental health services.
• On March 30, 2022, GAO published a report entitled, Mental Health Care: Access Challenges for Covered Consumers and Relevant Federal Efforts. Based on stakeholders interviewed and research reviewed, GAO found that consumers with coverage for mental health care experience challenges finding in-network providers. For example, in-network providers may not be accepting new patients or there may be long wait times to see them. Such challenges could cause consumers to face higher health care costs, delays in receiving care, or difficulties in finding a provider close to home. Factors contributing to these challenges included low reimbursement rates for mental health services and inaccurate or out-of-date information on provider networks.
• On March 31, 2022, GAO published a report entitled, Medicaid: CMS Should Assess Effect of Increased Telehealth Use on Beneficiaries' Quality of Care. GAO’s analysis of CMS data in five selected states shows that the number and percentage of services delivered via telehealth and Medicaid beneficiaries receiving them increased exponentially at the beginning of the COVID-19 pandemic in March 2020. From March 2020 through February 2021, 32.5 million services were delivered via telehealth to about 4.9 million beneficiaries in the five states, compared with 2.1 million services to about 455,000 beneficiaries in the 12 months prior to the pandemic.
• On March 31, 2022, HHS OIG published a report entitled, Medicare Part D and Beneficiaries Could Realize Significant Spending Reductions With Increased Biosimilar Use. OIG found that Medicare Part D and its beneficiaries could realize significant spending reductions if biosimilar use becomes more widespread, but the lack of biosimilar coverage on Part D formularies may limit increased utilization. OIG estimated that with increased use of biosimilars instead of reference products, Part D and beneficiary spending could have been considerably reduced in 2019. Specifically, Part D spending on biologics with available biosimilars could have decreased by $84 million, or 18 percent, if all biosimilars had been used as frequently as the most-used biosimilars. Additionally, beneficiaries’ out-of-pocket costs for these drugs could have decreased by $1.8 million, or 12 percent.
• On March 31, 2022, the Bipartisan Policy Center (BPC) published a report entitled, An Updated Policy Roadmap: Caring for Those with Complex Needs. BPC has issued more than a dozen reports with recommendations addressing complex care, some of which have been enacted into law or incorporated into regulations or other agency guidance. This report draws on recommendations from 12 previous reports to lay out a roadmap of policy solutions that Congress and federal agencies should still consider. This report presents the recommendations in two parts. Part I focuses on proposals that improve health and long-term services and supports for low-income individuals through the Medicaid program. Part II includes recommendations to provide support for middle- and higher-income individuals who may also face catastrophic long-term care costs, often causing them to exhaust their financial resources until they must rely on Medicaid.

IV. Other Health Policy News

• On March 28, 2022, President Biden released his FY 2023 budget request, which included $127.3 billion for HHS. The budget reflects the Biden Administration’s priorities, such as reinvesting in public health, and making major investments in areas like overdose prevention, mental health, maternal health, cancer, and HIV. It also advances equity through the work of the federal government and focuses on programs that serve people of color and other marginalized populations. The full budget request can be found here. HHS also released an accompanying FY 2023 budget in brief, which can be found here.
• On March 30, 2022, HHS announced it is awarding $256.6 million in grant funding to support 76 grantees to deliver equitable, affordable, client-centered, and high-quality family planning services. These grants will restore access to Title X services nationwide and fill service gaps caused by more than a quarter of Title X providers withdrawing from the program over the past two and a half years in response to the previous administration’s Title X rule. More information on this funding can be found here.
• On March 31, 2022, HHS announced that CMS is announcing it will offer more than $110 million to expand access to home and community-based services (HCBS) through Medicaid’s Money Follows the Person (MFP) program. First authorized in 2005, MFP has provided states with $4.06 billion to support people who choose to transition out of institutions and back into their homes and communities. The new Notice of Funding Opportunity (NOFO) makes individual awards of up to $5 million available for more than 20 states and territories not currently participating in MFP. These funds will support initial planning and implementation to get the state/territory programs off the ground, which would ensure more people with Medicaid can receive high-quality, cost-effective, person-centered services in a setting they choose. More information on this funding can be found here.

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