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, Congress passed a Continuing Resolution that funds the government through December 16 and reauthorizes FDA’s user fee agreements through fiscal year 2027. Read more about this action and other news below.
I. Regulations, Notices & Guidance
- On September 27, 2022, the Centers for Medicare & Medicaid Services (CMS) issued a notice entitled, Medicare Program; Medicare Part B Monthly Actuarial Rates, Premium Rates, and Annual Deductible Beginning January 1, 2023. This notice announces the monthly actuarial rates for aged (age 65 and over) and disabled (under age 65) beneficiaries enrolled in Part B of the Medicare Supplementary Medical Insurance (SMI) program beginning January 1, 2023. In addition, this notice announces the monthly premium for aged and disabled beneficiaries, the deductible for 2023, and the income-related monthly adjustment amounts to be paid by beneficiaries with modified adjusted gross income above certain threshold amounts.
- On September 27, 2022, CMS issued a notice entitled, Medicare Program; CY 2023 Part A Premiums for the Uninsured Aged and for Certain Disabled Individuals Who Have Exhausted Other Entitlement. This notice announces Medicare’s Hospital Insurance Program (Medicare Part A) premium rates for uninsured enrollees in calendar year (CY) 2023. This premium is paid by enrollees aged 65 and over who are not otherwise eligible for benefits under Medicare Part A and by certain individuals with disabilities who have exhausted other entitlement benefits. The monthly Medicare Part A premium for the 12 months beginning January 1, 2023 for these individuals will be $506. The premium for certain other individuals as described in this notice will be $278.
- On September 27, 2022, CMS issued a notice entitled, Medicare Program; CY 2023 Inpatient Hospital Deductible and Hospital and Extended Care Services Coinsurance Amounts. This notice announces the inpatient hospital deductible, and the hospital and extended care services coinsurance amounts for services furnished in CY 2023 under Medicare Part A. The Medicare statute specifies the formulae used to determine these amounts.
- On September 27, 2022, the Food and Drug Administration (FDA) issued draft guidance entitled, Providing Over-the-Counter Monograph Submissions in Electronic Format; Draft Guidance for Industry; Availability. This guidance provides information on providing electronic submissions to FDA under the Federal Food, Drug, and Cosmetic Act (FD&C Act). This guidance is intended to assist submitters by describing the electronic over-the-counter (OTC) monograph submissions requirement in the FD&C Act and by providing recommendations and other information on how to send such OTC monograph submissions to FDA in an electronic format.
- On September 27, 2022, FDA issued final guidance entitled, Clinical Decision Support Software; Guidance for Industry and Food and Drug Administration Staff; Availability. This final guidance provides clarity on FDA’s oversight of clinical decision support (CDS) software intended for health care professionals and describes FDA’s regulatory approach to CDS software functions. This guidance clarifies the types of CDS functions that do not meet the definition of a device as amended by the 21st Century Cures Act (Cures Act).
- On September 27, 2022, FDA issued a proposed rule entitled, Protection of Human Subjects and Institutional Review Boards. This proposed rule, if finalized, would harmonize certain sections of FDA’s regulations on human subject protection and institutional review boards (IRBs), to the extent practicable and consistent with other statutory provisions, with the revised Federal Policy for the Protection of Human Subjects (the revised Common Rule), in accordance with the Cures Act. FDA believes the proposed changes, if finalized, will reduce regulatory burden on IRBs, sponsors, and investigators. In addition, FDA proposes related changes to the investigational device exemption (IDE) regulations to clarify and update the requirements for the submission of progress reports.
- On September 27, 2022, FDA issued a proposed rule entitled, Institutional Review Boards; Cooperative Research. FDA is proposing to replace current requirements for FDA-regulated cooperative research with new requirements that would require any institution located in the U.S. participating in FDA-regulated cooperative research to rely on review and approval by a single IRB for the portion of the research that is conducted in the U.S., with some exceptions. FDA is also proposing an IRB recordkeeping requirement for research that takes place at an institution in which IRB oversight is conducted by an IRB that is not operated by the institution. FDA is proposing these revisions to streamline the IRB review process and decrease administrative burdens and inefficiencies for investigators and IRBs without compromising human subject protections. This proposed rule would harmonize FDA’s requirements for cooperative research and IRB records, to the extent practicable and consistent with statutory provisions, with the revised Common Rule and is being issued in accordance with a provision of the Cures Act.
- On September 28, 2022, FDA issued a proposed rule entitled, Food Labeling: Nutrient Content Claims; Definition of Term “Healthy”. FDA is proposing to update the definition for the implied nutrient content claim “healthy” to be consistent with current nutrition science and federal dietary guidance, especially the Dietary Guidelines for Americans, regarding how consumers can maintain healthy dietary practices. This action, if finalized, will revise the requirements for when the term “healthy” can be used as an implied claim in the labeling of human food products to indicate that a food’s level of nutrients may help consumers maintain healthy dietary practices that conform to dietary recommendations.
- On September 29, 2022, CMS issued a notice entitled, Medicare Program; Medicare Appeals; Adjustment to the Amount in Controversy Threshold Amounts for Calendar Year 2023. This notice announces the annual adjustment in the amount in controversy (AIC) threshold amounts for Administrative Law Judge (ALJ) hearings and judicial review under the Medicare appeals process. The adjustment to the AIC threshold amounts will be effective for requests for ALJ hearings and judicial review filed on or after January 1, 2023. The calendar year 2023 AIC threshold amounts are $180 for ALJ hearings and $1,850 for judicial review.
- October 19-20, 2022: The Department of Health and Human Services (HHS) announced a public meeting of the Secretary’s Advisory Committee on Human Research Protections (SACHRP). The meeting agenda will include a discussion of the impact of social media use by research subjects. The discussion will be followed by the review and potential amendment of previously approved SACHRP recommendations on the ethical and regulatory considerations for the use of artificial intelligence in human subject research.
- October 24, 2022: HHS announced a public meeting of the Advisory Council on Alzheimer’s Research, Care, and Services. The meeting agenda will include presentations on access to long-term services and supports (LTSS) as well as end-of-life challenges for people living with Alzheimer’s disease and related dementias (ADRD). Federal agencies will also provide updates including a presentation from the Administration for Community Living (ACL) on the new National Strategy to Support Family Caregivers.
- October 26, 2022: FDA announced a public meeting to discuss the Animal Generic Drug User Fee Act (AGDUFA IV). The meeting agenda will include a discussion of proposed recommendations for the reauthorization of AGDUFA IV for fiscal years (FYs) 2024 through 2028.
- October 27, 2022: The National Institutes of Health (NIH) announced a public meeting of the Office of AIDS Research Advisory Council (OARAC). The meeting agenda will include a report from the OAR director; presentations from the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR), the U.S. Military HIV Research Program, and NIH-wide programs and initiatives; updates from the Clinical Guidelines Working Groups of OARAC; and updates from NIH HIV-related advisory councils.
- November 3, 2022: The Centers for Disease Control and Prevention (CDC) announced a public meeting of the Healthcare Infection Control Practices Advisory Committee (HICPAC). The agenda will include updates from the Healthcare Personnel Guideline Workgroup, the Isolation Precautions Guideline Workgroup, the Neonatal Intensive Care Unit Guideline Workgroup, and the Neonatal Pediatric Surveillance Workgroup.
- November 9, 2022: NIH announced a public meeting of the National Cancer Institute (NCI) Clinical Trials and Translational Research Advisory Committee (CTAC). The meeting agenda will include a strategic discussion of NCI CTAC’s research programs.
- December 8, 2022: CDC announced a public meeting of the Lead Exposure and Prevention Advisory Committee (LEPAC). The agenda will include presentations from school health organizations, healthy housing organizations, and the(?) Environmental Protection Agency (EPA) on lead in schools and discussions on these topics.
- December 14-15, 2022: CMS announced a public town hall meeting to discuss FY 2024 applications for new medical services and technologies add-on payments. The meeting agenda will include interested parties presenting comments, recommendations, and data regarding whether the FY 2024 new medical services and technologies applications meet the substantial clinical improvement criterion.
II. Congressional Hearings
U.S. House of Representatives
- On September 29, 2022, the House Committee on Oversight and Reform held a hearing entitled, Examining the Harm to Patients from Abortion Restrictions and the Threat of a National Abortion Ban. Witnesses present included: Kelsey Leigh, Advocate; Dr. Bhavik Kumar, Medical Director for Primary and Trans Care, Planned Parenthood Gulf Coast; Dr. Nisha Verma, Fellow, Physicians for Reproductive Health; Jocelyn Frye, President, National Partnership for Women & Families; and Dr. Monique C. Wubbenhorst, Senior Research Associate, de Nicola Center for Ethics and Culture, University of Notre Dame.
III. Reports, Studies & Analyses
- On September 26, 2022, the Government Accountability Office (GAO) published a report entitled, Medicare Telehealth: Actions Needed to Strengthen Oversight and Help Providers Educate Patients on Privacy and Security Risks. This report describes, among other issues, (1) the utilization of telehealth services, (2) CMS’ efforts to identify and monitor risks posed by Medicare telehealth waivers, and (3) a change the HHS’ Office of Civil Rights (OCR) made to its enforcement of regulations governing patients’ protected health information (PHI) during the COVID-19 public health emergency (PHE). GAO found that use of telehealth services increased from about 5 million services pre-waiver (April to December 2019) to more than 53 million services post-waiver (April to December 2020). Total utilization of all Medicare services declined by about 14 percent post-waiver due to a 25 percent drop in in-person service use. GAO made three recommendations for CMS to strengthen its telehealth oversight, and one for OCR to provide additional direction to providers to explain privacy and security risks to patients.
- On September 28, 2022, GAO published a report entitled, Medicaid: Efforts to Address Fraud in Nonemergency Medical Transportation. This report describes (1) states’ approaches to administer the Medicaid nonemergency medical transportation benefit; (2) outcomes and findings of related fraud investigations and program audits; and (3) strategies selected states used to address fraud related to nonemergency medical transportation. GAO found that state approaches to administering the nonemergency medical transportation benefit include administering the benefit directly (in-house), contracting with third-party transportation brokers, or contracting with managed care organizations (MCOs). GAO found that in order to mitigate fraud, states employed various strategies such as conducting provider and vehicle screenings; and requiring pre-trip approvals and post-trip validations.
- On September 28, 2022, the Congressional Budget Office (CBO) published a report entitled, The Opioid Crisis and Recent Federal Policy Responses. This report details the timeline and consequences of the U.S.’s opioid epidemic. The report also examines the contributing factors and federal responses to the opioid epidemic, as well as the effects the COVID-19 pandemic had on the crisis. CBO found that there have been more than 500,000 opioid-involved deaths since 2000. The report also highlights how Congress enacted three laws between 2016 and 2018 aimed at lowering the demand for and supply of opioids and reducing their harm. Additionally, CBO found that opioid misuse increased during the pandemic as people experienced worsened mental health, more social isolation, greater job losses, and reduced access to treatment.
- On September 29, 2022, HHS’ Office of the Inspector General (OIG) published a report entitled, HHS’s and HRSA’s Controls Related to Selected Provider Relief Fund Program Requirements Could Be Improved. OIG’s objective was to assess whether HHS’s and the Health Resources and Services Administration’s (HRSA) controls related to selected Provider Relief Funding (PRF) program requirements (i.e., those related to the requirements for submission of revenue information and attestation of rejection of payments) ensured that providers received the correct payments from the Phase 1 General Distribution. OIG found that HHS’s and HRSA’s procedures did not include: (1) requesting and reviewing providers’ supporting documentation to verify estimated revenue losses in March and April 2020, (2) subtracting the automatic payments made to providers’ subsidiaries when certain nonautomatic payments were calculated, and (3) specifying a deadline for providers to return rejected payments. OIG recommended that HRSA continues to perform post-payment quality control reviews of selected providers.
- On September 29, 2022, CBO published a report entitled, Policy Approaches to Reduce What Commercial Insurers Pay for Hospitals’ and Physicians’ Services. In this report, CBO outlines multiple policy approaches available to Congress that would reduce the prices that commercial insurers pay providers and thereby reduce premiums for that coverage. CBO’s policy options include promoting competition among providers, promoting price transparency, and capping the level or growth rate of prices. CBO determined that price-cap policies would have the largest effect on prices, but that each of the three policy approaches would reduce the federal deficit.
IV. Other Health Policy News
- On September 26, 2022, HHS announced that it is making additional data publicly available that provides more information about the ownership of all Medicare-certified nursing homes. This data will give state licensing officials, state and federal law enforcement, researchers, and the public an enhanced ability to identify common owners of nursing homes across nursing home locations. This information can be linked to other data sources to identify the performance of facilities under common ownership, such as owners affiliated with multiple nursing homes with records of poor performance. The data provides detailed information on the ownership of the approximately 15,000 nursing homes certified as a Medicare Skilled Nursing Facility (SNF) – regardless of any change in ownership. For example, the expanded data elements include information about each organizational owner, such as whether it is a holding company or a consulting firm. More information on this announcement can be found here.
- On September 28, 2022, the Biden Administration held the first White House Conference on Hunger, Nutrition, and Health in more than 50 years. During his remarks, President Biden announced a goal of ending hunger and increasing healthy eating and physical activity by 2030. The conference included panel sessions featuring food and nutrition experts from both the public and private sectors and highlighted the release of the Biden Administration’s National Strategy on Hunger, Nutrition, and Health. The Biden Administration also announced over $8 billion in public-private partnerships, such as a partnership with Google to allow Medicare and Medicaid enrollees to schedule health care appointments directly within the Google Search tool. Further, to coincide with the conference, HHS announced that it had approved Medicaid 1115 waivers in Oregon and Massachusetts that will allow both states to enhance Medicaid coverage for health-related social needs. Oregon will expand coverage for food assistance, housing supports, and other interventions for individuals experiencing certain life transitions, including homelessness. The Massachusetts 1115 waiver will allow the state to provide time-limited housing supports, clinical nutrition education, and medically-tailored food assistance services to at-risk populations. More information on the White House Conference on Hunger, Nutrition, and Health can be found here.
- On September 29, 2022, the Senate voted 72-25 to pass a stopgap government funding bill, known as a Continuing Resolution (CR), that will avoid a government shutdown. The CR, which provides funding through December 16, 2022, includes a provision that would reauthorize the Food and Drug Administration’s (FDA) user fee agreements (UFAs) for fiscal years (FYs) 2023 through 2027. UFAs are fees paid to FDA by the pharmaceutical, medical device, generic drug, and biosimilar industries to fund the timely review and development of innovative therapeutics. Another inclusion in the bill is $62 million in funding to support the National Suicide Prevention Lifeline. The CR also includes short-term extensions of expiring Medicare provisions for increased rural hospitals payments under the Medicare Dependent Hospital program and the low volume hospital adjustment as well as a Medicaid provision for increased federal funding for U.S. territories. The CR does not include Biden Administration requests for $22 billion in funding to combat the COVID-19 pandemic and $4 billion to support the government’s ongoing monkeypox response. On September 30, 2022, the House passed the CR by a vote of 230-201, sending the CR to President Biden for his signature before the midnight deadline. More information on this action can be found here.
- On September 29, 2022, CMS announced that Medicare enrollees will see lower premiums for Medicare Advantage (MA) and Medicare Part D prescription drug plans in 2023. Additionally, Medicare beneficiaries’ prescription drug coverage will have improved and more affordable benefits, including a $35 cost-sharing limit on a month’s supply of each covered insulin product, as well as no cost-sharing requirements for adult vaccines that are recommended by the Advisory Committee on Immunization Practices (ACIP). The projected average premium for 2023 MA plans is $18 per month, a decline of nearly 8 percent from the 2022 average premium of $19.52. MA plans will continue to offer a wide range of supplemental benefits in 2023, including eyewear, hearing aids, preventive and comprehensive dental benefits, access to meals (for a limited duration), over-the-counter items, and fitness benefits. More information on this announcement can be found here.
- On September 30, 2022, HRSA awarded more than $266 million in American Rescue Plan (ARP) funding to grow the community and public health workforce. HRSA is awarding $225.5 million to 83 grantees as part of the Community Health Worker Training Program, which is a new multiyear program that will provide training and apprenticeships to support an estimated 13,000 new community health workers. HRSA is also awarding $40.7 million to 29 grantees through the Public Health Scholarship Program, which will incentivize individuals to pursue training and careers in public health, including as epidemiologists and other positions critical to community public health needs. This program aims to build public health workforce capacity in cities and states across the country. More information on this funding can be found here.
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