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, the Medicare Trustees released a report about the Medicare HI Trust Fund projecting Medicare would remain solvent until 2028. Read more about this report and other news below.
I. Regulations, Notices & Guidance
- On May 31, 2022, the Department of Health and Human Services (HHS) issued a notice entitled, Establishment of the Office of Environmental Justice. This notice announces the modification of the Office of the Assistant Secretary for Health’s (OASH’s) structure and the establishment of the Office of Environmental Justice (OEJ) in OASH’s Office of Climate Change and Health Equity (OCCHE). This notice reflects the establishment of an office to coordinate and provide expertise to support HHS’ efforts to protect the health of disadvantaged communities and vulnerable populations on the frontlines of pollution and environmental hazards.
- On May 31, 2022, the Food and Drug Administration (FDA) issued a final rule entitled, Medical Devices; Cardiovascular Devices; Classification of the Coronary Artery Disease Risk Indicator Using Acoustic Heart Signals. With this rule, FDA is classifying the coronary artery disease risk indicator using acoustic heart signals into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the coronary artery disease risk indicator using acoustic heart signals’ classification.
- On June 1, 2022, the Centers for Disease Control and Prevention (CDC) issued a notice entitled, Solicitation of Nominations for Appointment to the CDC/HRSA Advisory Committee on HIV, Viral Hepatitis and STD Prevention and Treatment (CHACHSPT). CHACHSPT consists of 18 experts in fields associated with public health; epidemiology; laboratory practice; immunology; infectious diseases; drug abuse; behavioral science; health education; healthcare delivery; state health programs; clinical care; preventive health; medical education; health services and clinical research; and healthcare financing. Nominations for membership in CHACHSPT must be received no later than October 1, 2022.
- On June 3, 2022, the National Institutes of Health (NIH) issued a notice entitled, National Institute of Biomedical Imaging and Bioengineering (NIBIB); Notice of Proposed Reorganization. NIBIB is hosting a public online forum to enable public discussion of the Institute’s proposal to establish the Center for Biomedical Imaging and Technology Acceleration (βETA). The proposed reorganization aims to accelerate the development, validation, and dissemination of high-impact biomedical technologies to address urgent national and global health needs. The online forum will allow members of the public to review the reorganization proposal and submit comments. The public online forum will become available on June 21, 2022, and will remain open for five calendar days, through June 25, 2022.
- On June 3, 2022, FDA issued final guidance entitled, Electromagnetic Compatibility of Medical Devices; Guidance for Industry and Food and Drug Administration Staff; Availability. This guidance is intended to recommend information that should be provided in a premarket submission. For example, a premarket approval application (PMA), humanitarian device exemption (HDE), premarket notification (510(k)) submission, investigational device exemption (IDE), De Novo requests, and certain biologics license applications (BLAs) and investigational new drug (IND) applications to demonstrate electromagnetic compatibility (EMC) for electrically powered medical devices and medical devices with electrical or electronic functions.
- On June 3, 2022, FDA issued a final rule entitled, Medical Devices; Gastroenterology-Urology Devices; Classification of the Non-Implanted Electrical Stimulation Device for Management of Premature Ejaculation. FDA is classifying the nonimplanted electrical stimulation device for management of premature ejaculation into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the non-implanted electrical stimulation device for management of premature ejaculation’s classification.
- June 23, 2022: The Centers for Medicare & Medicaid Services (CMS) announced a public meeting of the Advisory Panel on Outreach and Education (APOE). The agenda will include a listening session with CMS leadership, a recap of the previous meeting, and a discussion of CMS programs, initiatives, and priorities. The agenda will also include a meeting summary, a review of recommendations, and a discussion of next steps.
- June 29, 2022: NIH announced a public hearing to discuss NIBIB’s proposal to establish βETA. The public hearing will take place using NIBIB’s social media accounts. The agenda will include a public discussion of NIBIB’s proposal.
- June 29, 2022: NIH announced a public meeting of the National Cancer Institute (NCI) Council of Research Advocates. The agenda will include opening remarks, NCI updates, a legislative update, and the acting director’s update.
- June 30, 2022: The Agency for Healthcare Research and Quality (AHRQ) announced a public meeting to discuss the implementation of the Common Formats with software developers and other interested parties. This meeting is designed as an interactive forum where software developers can provide input on use of the formats. AHRQ especially requests participation by and input from those entities which have used AHRQ’s technical specifications and implemented, or plan to implement, the Common Formats electronically. The Common Formats include technical specifications to facilitate the collection of electronically comparable data by Patient Safety Organizations (PSOs) and other entities.
- July 21, 2022: AHRQ announced a public meeting of the National Advisory Council (NAC) for Healthcare Research and Quality. The meeting will begin with an introduction of NAC members and a report by the AHRQ Director. NAC will then commence a discussion on the meaning of quality across healthcare delivery systems in the future and the impact of innovations in the healthcare marketplace.
II. Reports, Studies & Analyses
- On May 31, 2022, the Kaiser Family Foundation (KFF) published a report entitled, Price Regulation, Global Budgets, and Spending Targets: A Road Map to Reduce Health Care Spending and Improve Affordability. In this report, KFF examines several policy options to reduce health care spending and improve affordability through constraints on prices, including price regulation (i.e., setting or capping prices or price growth), global budgets (i.e., limiting spending to a budget), and spending growth targets (i.e., limiting spending growth). The report also provides examples of these policy options in practice, discusses the tradeoffs and implications of adopting each option, and discusses the legislative and regulatory pathways for adopting new policies.
- On May 31, 2022, the Government Accountability Office (GAO) published a report entitled, Private Health Insurance: Limited Data Hinders Understanding of Short-Term Plans’ Role and Value during the COVID-19 Pandemic. In this report, GAO describes what is known about short-term health insurance plans and the role that they might play for individuals who lost employer sponsored insurance (ESI) during the COVID-19 pandemic. Stakeholder views of the value of short-term plans in meeting consumer needs are also discussed. GAO found that limited and inconsistent data hinder understanding of the role short-term plans played during the COVID-19 pandemic for those who lost ESI, such as whether they were used by consumers as temporary coverage or as a longer-term alternative to plans compliant with the Patient Protection and Affordable Care Act (PPACA).
- On May 31, 2022, Kaufman Hall published a report entitled, National Hospital Flash Report: May 2022. The report details how hospitals and health systems saw significant revenue declines in April 2022. Additionally, gross operating, inpatient, and outpatient revenues for hospitals and health systems all dropped by about 7 percent in April compared to March. The report noted that hospital and health system expenses were down from March 2022 but remained high in April 2022 and well above pre-pandemic levels, while expenses were up 8.3 percent year over year.
- On June 1, 2022, KFF published a report entitled, Traditional Medicare Spending Fell Almost 6% in 2020 as Service Use Declined Early in the COVID-19 Pandemic. KFF’s analysis used data from CMS to examine trends in spending and utilization by type of health care service between 2010 and 2020 for Medicare beneficiaries who were enrolled in both Part A and Part B of traditional Medicare. KFF found that, in 2020, spending for traditional Medicare beneficiaries declined for the first time in more than two decades. The drop in spending followed the sharp decline in the use of health care services during the initial months of the COVID-19 pandemic and reflects a decrease in spending among traditional Medicare beneficiaries on most health care goods and services.
- On June 2, 2022, the U.S. Treasury Department and the Boards of Trustees of the Federal Hospital Insurance Trust Fund and the Federal Supplementary Medical Insurance Trust Fund issued their annual report entitled, 2022 Annual Report of the Boards of Trustees of the Federal Hospital Insurance and Federal Supplementary Medical Insurance Trust Funds. Notably, the 2022 report estimates that the Hospital Insurance (HI) trust fund will be depleted in 2028, which is two years later than was projected in the 2021 report. HI income is projected to outstrip the 2021 estimates because the number of covered workers and average wages are projected to increase. Additionally, HI expenditures are anticipated to be lower than the 2021 estimates largely due to the pandemic but are estimated to be larger than the 2021 estimates after 2023 due to increased provider payments. The 2022 report projected the Supplementary Medical Insurance (SMI) trust fund will be adequately funded over the next decade and beyond because the income generated from Medicare Part B and Part D premiums is reset each year to account for anticipated costs and ensure a reserve is available for Part B.
III. Other Health Policy News
- On May 31, 2022, the Indian Health Service (IHS) announced the appropriation of $700 million in each fiscal year from FY 2022 through FY 2026, for a total of $3.5 billion for the IHS Sanitation Facilities Construction Program. The funding was appropriated to IHS in the Bipartisan Infrastructure Law. The funding will provide 71,000 American Indian and Alaska Native homes with critical services like water wells and onsite wastewater disposal systems and connections to community water supply and wastewater disposal systems. More information on this funding can be found here.
- On June 1, 2022, HHS, through the Health Resources and Services Administration (HRSA), published an article entitled, Blueprint for Change: A National Framework for a System of Services for Children and Youth with Special Health Care Needs. The Blueprint for Change was published in the Pediatrics journal and outlines a national framework for improving care for children and youth with special health care needs (CYSHCN). To positively transform care for children and youth with special health care needs, The Blueprint for Change is organized around four critical areas: health equity, family and child well-being and quality of life, access to services, and financing of services. The Blueprint for Change provides a definition, overall vision, key principles, and actionable strategies for each area, and recognizes that disability is a natural part of the human experience. More information on this announcement can be found here.
- On June 3, 2022, HHS notified states that they now have an additional year — through March 31, 2025 — to use funding made available by the American Rescue Plan (ARP) to enhance, expand, and strengthen home- and community-based services (HCBS) for people with Medicaid who need long-term services and supports. This funding allows states to identify and implement changes aimed at addressing existing HCBS workforce and structural issues. It will also help expand states’ capacity to provide critical services and meet the needs of family caregivers and people on HCBS waitlists. More information on this action can be found here.
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