Alston & Bird Health Care Week in Review – April 2022 #2 – JD Supra

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, CMS announced that Medicare Part B beneficiaries will now be eligible for free over-the-counter COVID-19 tests during the COVID-19 public health emergency. Read more about this action and other news below.

I. Regulations, Notices & Guidance

On April 4, 2022, the Centers for Disease Control and Prevention (CDC) issued a notice entitled, Amended Order Implementing Presidential Proclamation on Advancing the Safe Resumption of Global Travel During the COVID-19 Pandemic. CDC amended its Order issued October 20, 2021, to align with revised CDC guidance published on January 4, 2022, related to isolation and quarantine after travel. The order reduces the number of days for travelers to self-quarantine after international travel from seven days to five days. The number of days for isolation for those who are diagnosed with COVID-19 or have COVID-19 symptoms is also reduced from 10 days to five days.
On April 5, 2022, CDC issued a notice entitled, Solicitation of Nominations for Appointment to the Healthcare Infection Control Practices Advisory Committee (HICPAC). CDC is seeking nominations for membership on the HICPAC. The HICPAC consists of 14 experts in fields including but not limited to, infectious diseases, infection prevention, healthcare epidemiology, nursing, clinical microbiology, surgery, hospitalist medicine, internal medicine, epidemiology, health policy, health services research, public health, and related medical fields.
On April 6, 2022, the Food and Drug Administration (FDA) issued a notice entitled, Chronic Hepatitis B Virus Infection: Developing Drugs for Treatment; Guidance for Industry; Availability. The purpose of this guidance is to assist sponsors in the clinical development of drugs and biologics for the treatment of chronic hepatitis B virus (HBV) infection from the initial investigational new drug application (IND) through the new drug application (NDA)/biologics license application (BLA) and post marketing phases. This guidance finalizes the draft guidance of the same title issued on November 2, 2018.
On April 6, 2022, the Food and Drug Administration (FDA) issued a notice entitled, M7(R2) Addendum: Application of the Principles of the ICH M7 Guideline to Calculation of Compound-Specific Acceptable Intakes; International Council for Harmonisation; Draft Guidance for Industry; Availability. The draft guidance adds monographs for seven new compounds to the M7 Guideline which outlines considerations for assessment and control of DNA reactive (mutagenic) impurities to limit potential carcinogenic risk. The compounds are: acetaldehyde, dibromoethane, epichlorohydrin, ethyl bromide, formaldehyde, styrene, and vinyl acetate. The addendum is intended to update the M7 Guideline in line with the ICH process for its maintenance and includes other revisions.
On April 6, 2022, the Department of Health and Human Services (HHS) issued a notice entitled, Mandatory Guidelines for Federal Workplace Drug Testing Programs. HHS is proposing to revise the Mandatory Guidelines for Federal Workplace Drug Testing Programs using Oral Fluid (OFMG) which published in the Federal Register of October 25, 2019.
On April 7, 2022, the White House issued a notice entitled, Continuing to Strengthen Americans’ Access to Affordable, Quality Health Coverage. The executive order establishes the Biden Administration’s commitment to the Affordable Care Act (ACA) and directs executive departments and agencies to review agency actions, policies, and guidance to ensure they comply with that goal.
On April 7, 2022, FDA issued a notice entitled, Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions; Draft Guidance for Industry and Food and Drug Administration Staff; Availability. This draft guidance is intended to further emphasize the importance of ensuring that devices are designed securely, are designed to be capable of mitigating emerging cybersecurity risks throughout the Total Product Life Cycle, and to clearly outline FDA’s recommendations for premarket submission content to address cybersecurity concerns.
On April 7, 2022, FDA issued a notice entitled, Use of Whole Slide Imaging in Nonclinical Toxicology Studies: Questions and Answers; Draft Guidance for Industry; Availability. When final, this guidance will represent FDA’s current thinking on the use of whole slide images during good laboratory practice (GLP)- compliant toxicology studies using non-human specimens.
On April 7, 2022, HHS issued a notice entitled, Request for Information (RFI): 2022 HHS Environmental Justice Strategy and Implementation Plan Draft Outline. HHS is issuing the RFI to receive input from the public on HHS’ draft outline to further the development of the 2022 Environmental Justice Strategy and Implementation Plan. With the engagement of and input from the public, the 2022 Environmental Justice Strategy and Implementation Plan will serve as a guide to confront environmental and health disparities and implement a multifaceted approach that will serve vulnerable populations and communities disproportionately impacted by environmental burdens.
On April 7, 2022, the Centers for Medicare & Medicaid Services issues a proposed rule entitled, Radiation Oncology (RO) Model. CMS is proposing to delay the current start date of the RO Model to a date to be determined through future rulemaking, and to modify the definition of the model performance period to provide that the start and end dates of the model performance period for the RO Model will be established in future rulemaking.
On April 7, 2022, CMS issued a final rule with comment period entitled, Medicare Program; Maximum Out-of-Pocket (MOOP) Limits and Service Category Cost Sharing Standards. This final rule with comment period (FC) will finalize the two remaining proposals from the proposed rule entitled, Medicare and Medicaid Programs; Contract Year 2021 and 2022 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit Program, Medicaid Program, Medicare Cost Plan Program, and Programs of All-Inclusive Care for the Elderly. The two proposals being finalized here from the February 2020 proposed rule include the maximum out-of-pocket (MOOP) limits for Medicare Parts A and B services and cost sharing limits for Medicare Parts A and B services, including service category cost sharing limits and per member per month actuarial equivalence cost sharing. In addition, CMS is requesting comments in section III of this FC on new or different ways to update and change cost sharing limits in future years for service categories subject to the regulations, including mental health services.
On April 8, 2022, FDA issued final guidance entitled, E8(R1) General Considerations for Clinical Studies; International Council for Harmonisation; Guidance for Industry. The guidance describes internationally accepted principles and practices for the design and conduct of clinical studies of drug and biological products. In addition, the guidance provides an overview of the types of clinical studies that may be performed and data sources used during the product’s life cycle. The guidance is intended to promote the quality of the studies submitted to regulatory authorities, while allowing for flexibility.
On April 8, 2022, FDA issued a notice of guidance entitled, Safety and Performance Based Pathway Device-Specific Guidances; Guidance for Industry and Food and Drug Administration Staff. In this notice, FDA is announcing the availability of two final device-specific guidance documents for the Safety and Performance Based Pathway–specifically, Surgical Sutures–Performance Criteria for Safety and Performance Based Pathway and Orthopedic Fracture Fixation Plates–Performance Criteria for Safety and Performance Based Pathway. The device-specific guidances identified in this notice were developed in accordance with the finalized guidance entitled, Safety and Performance Based Pathway.

Events Notices

April 19, 2022: FDA announced a public meeting entitled, Medical Device User Fee Amendments. The purpose of the meeting is to discuss proposed recommendations for the reauthorization of the Medical Device User Fee Amendments (MDUFA) for fiscal years (FYs) 2023 through 2027.
May 2-3, 2022: HHS announced a public meeting of the Advisory Council on Alzheimer’s Research, Care, and Services. The Advisory Council provides advice on how to prevent or reduce the burden of Alzheimer’s disease and related dementias on people with the disease and their caregivers. During the meeting, the Advisory Council will celebrate accomplishments since the release of the National Plan to Address Alzheimer’s Disease in May 2012.
May 3, 2022: CDC announced a public meeting of the Advisory Committee to the Director (ACD). The agenda will include discussions regarding CDC’s current and future work in the following topic areas: 1) data modernization; 2) laboratory quality; and 3) health equity. The ACD will consider the formation of working groups for each of the first two topics and hear a report from the existing health equity working group on the third topic.
May 11-12, 2022: FDA announced a public meeting of the Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee. On May 11, 2022, the subcommittee will discuss the development of a conceptual framework that will inform the decision making of FDA on sponsor plans and requests for waivers of early pediatric investigations of molecularly targeted cancer drugs and biologics when multiple same-in-class products are approved and/or in development, recognizing that the rarity of pediatric cancers may preclude the feasibility of investigations of multiple products. On May 12, 2022, the subcommittee will consider and discuss the potential utility and steps to validation of an intermediate clinical endpoint, response to induction therapy, in the development of new drugs for the first-line treatment of patients with high-risk neuroblastoma.
May 13, 2022: The National Institutes for Health (NIH) announced a public meeting of the Office of the Director. The meeting will include a discussion of policies and procedures that apply to the regular review of NIH intramural scientists and their work.
May 17, 2022: NIH announced a public meeting of the National Institute of Biomedical Imaging and Bioengineering. The agenda will include Report from the Institute Director, Council Members and other Institute Staff.
May 18, 2022: The Occupational Safety and Health Administration (OSHA) announced a public meeting of Healthcare Worker Whistleblower Stakeholders. OSHA is hosting the meeting to solicit comments and suggestions from stakeholders on issues facing the agency in the administration of the whistleblower laws it enforces.
May 25, 2022: CDC announced a public meeting of the Advisory Board on Radiation and Worker Health (ABRWH), Subcommittee on Procedures Reviews, National Institute for Occupational Safety and Health (NIOSH). The agenda will include discussions on the following: Case reviews for Westinghouse Nuclear Fuels Division, Norton Company, Parameters to Consider When Processing Claims for Construction Trade Workers, Document Tracking, Preparation for the August 2022 full ABRWH Meeting, and Newly Issued Guidance Documents and Supplemental topics.
May 26, 2022: CDC announced a public meeting of the Board of Scientific Counselors, National Center for Health Statistics (BSC, NCHS). The meeting agenda will include a Center update by the NCHS Director; an update on CDC’s Data Modernization Initiative (DMI) and DMI funded projects at NCHS; a report out from the Population Health Survey Planning, Methodology and Data Presentation (PHSPMDP) Workgroup on their assessment of the use of panel survey data by NCHS, and; a report out from the new Workgroup to Consider and Assess Measures of Discrimination for use in NCHS surveys.
May 31-June 3, 2022: The Health Resources and Services Administration (HRSA) announced a public meeting of the National Advisory Council on Migrant Health (NACMH). NACMH will discuss topics and issues related to migratory and seasonal agricultural worker health.

II. Congressional Hearings

U.S. House of Representatives

On April 5, 2022, the House Committee on Natural Resources Subcommittee on Oversight & Investigations held a hearing entitled, The Opioid Crisis in Tribal Communities. Witnesses present included: The Honorable Chuck Hoskin, Jr., Principal Chief, Cherokee Nation; Ms. Maureen Rosette, Board Member, National Council of Urban Indian Health; Mr. Art Del Cueto, Vice President, Western Region National, Border Patrol Council; and Mr. Wayne Cortez, Peer Support Specialist, Riverside-San Bernardino Indian Health, Inc.
On April 5, 2022, the House Committee on Energy & Commerce Subcommittee on Health held a hearing entitled, Communities in Need: Legislation to Support Mental Health and Well-Being. Legislation discussed during the hearing includes: R. 2376, the Excellence in Recovery Housing Act, H.R. 2929, the Virtual Peer Support Act; H.R. 4251, Native Behavioral Health Access Improvement Act of 2021; H.R. 4944, Helping Kids Cope Act of 2021; H.R. 5218, the Collaborate in an Orderly and Cohesive Manner; H.R. 7073, the Into the Light for Maternal Mental Health Act; H.R. 7076, the Supporting Children’s Mental Health Care Access Act of 2022; H.R. 7232, the 9–8–8 and Parity Assistance Act of 2022; H.R. 7233, the Keeping Incarceration Discharges Streamlined for Children and Accommodating Resources in Education Act (KIDS CARES Act); H.R. 7234, the Summer Barrow Prevention, Treatment, and Recovery Act; H.R. 7235, the Substance Use Prevention, Treatment, and Recovery Services Block Grant Act of 2022; H.R. 7236, the Strengthen Kids’ Mental Health Now Act of 2022; H.R. 7237, the Reauthorizing Evidence-based and Crisis Help Initiatives Needed to Generate Improved Mental Health Outcomes for Patients Act of 2022 (REACHING Improved Mental Health Outcomes for Patients Act of 2022); H.R. 7238, the Timely Treatment for Opioid Use Disorder Act of 2022; H.R. 7241, the Community Mental Health Services Block Grant Reauthorization Act; H.R. 7248, the Continuing Systems of Care for Children Act; H.R. 7249, the Anna Westin Legacy Act of 2022; H.R. 7254, the Mental Health Justice and Parity Act of 2022; and H.R. 7255, the Garrett Lee Smith Memorial Reauthorization Act. Witnesses present included: Witnesses included: Miriam E. Delphin-Rittmon, Ph.D., Assistant Secretary for Mental Health and Substance Use, Substance Abuse and Mental Health Services Administration (SAMHSA); Carole Johnson, M.A., Administrator, HRSA; Rebecca W. Brendel, M.D., J.D., President-Elect, American Psychiatric Association; Sandy L. Chung, M.D., F.A.A.P., F.A.C.H.E., President-Elect, American Academy of Pediatrics; Steven Adelsheim, M.D., Clinical Professor of Psychiatry and Director, Stanford Center for Youth Mental Health and Wellbeing, Stanford University School of Medicine, Stanford Children’s Health; Debra Pinals, M.D., Medical Director, Behavioral Health and Forensic Programs, Michigan Department of Health and Human Services, On behalf of the National Association of State Mental Health Program Directors; Cassandra Price, M.B.A., Director, Office of Addictive Diseases, Georgia Department of Behavioral Health and Developmental Disabilities, On behalf of the National Association of State Alcohol and Drug Abuse Directors; and LeVail W. Smith, C.P.S.S., Peer Support Specialist Instructor and Mentor.
On April 6, 2022, the House Committee on Education & Labor held a hearing entitled, Examining the Policies and Priorities of the U.S. Department of Health and Human Services. Witnesses present included: The Honorable Xavier Becerra, Secretary, HHS.

U.S. Senate

On April 5, 2022, the Senate Committee on Health, Education, Labor, and Pensions (HELP) held a hearing entitled, FDA User Fee Agreements: Advancing Medical Product Regulation and Innovation for the Benefit of Patients. Witnesses present included: Cartier Esham, Ph.D., Chief Scientific Officer and Executive Vice President of Emerging Companies, Biotechnology Innovation Organization; David Gaugh, Senior Vice President, Sciences and Regulatory Affairs, Association for Accessible Medicines; Mark Leahey, President and Chief Executive Officer, Medical Device Manufacturers Association; and Liz Richardson, Director, Health Care Products Project, The Pew Charitable Trusts.
On April 5, 2022, the Senate Committee on Finance held a hearing entitled, The President’s Fiscal Year 2023 Health and Human Services Budget. Witnesses present included: The Honorable Xavier Becerra, Secretary, HHS.

III. Reports, Studies & Analyses

On April 4, 2022, the Kaiser Family Foundation (KFF) published an issue brief entitled, Nursing Facility Staffing Shortages During the COVID-19 Pandemic. This analysis presents the most recent national and state-level data on nursing facility-reported staff shortages and describes the Biden Administration’s new policy initiatives to address staffing and other quality issues in nursing facilities. National staff shortage trend data spans from May 2020, the first month when nursing facilities were required to report COVID-19 facility data to the CDC, through March 20, 2022, the most recent week of data available.
On April 4, 2022, KFF published an issue brief entitled, Medicaid Spending and Enrollment: Updated for FY 2022 and Looking Ahead to FY 2023. Early in the pandemic, Congress passed the Families First Coronavirus Response Act (FFCRA), which authorized a 6.2 percentage point increase in the federal Medicaid match rate (“FMAP”) for states that meet certain “maintenance of eligibility” (MOE) requirements, including a continuous enrollment requirement. This brief explores Medicaid enrollment and spending growth estimates, as reported by state Medicaid directors, for FY 2022 and projections for FY 2023.
On April 8, 2022, KFF published an issue brief entitled, What Happens When COVID-19 Emergency Declarations End? Implications for Coverage, Costs, and Access. This brief provides an overview of the major health-related COVID-19 federal emergency declarations that have been made, summarizes the flexibilities triggered by each, and identifies the implications for their ending, in the following areas: coverage, costs, and payment for COVID-19 testing, treatments, and vaccines; Medicaid coverage and federal match rates; telehealth; other Medicaid and Children’s Health Insurance Program (CHIP) flexibilities; other private insurance coverage flexibilities; access to medical countermeasures (vaccines, tests, and treatments) through FDA emergency use authorization (EUA); and liability immunity to administer medical countermeasures.

IV. Other Health Policy News

On April 1, 2022, HRSA announced the availability of $4.5 million for hiring, training, certifying, and compensating community-based doulas in areas with high rates of adverse maternal and infant health outcomes. This funding, provided through HRSA’s Healthy Start Initiative, will increase the total number of Healthy Start doula programs from 25 to approximately 50 nationwide. HRSA’s Healthy Start Initiative works to improve health before, during, and after pregnancy and reduce racial and ethnic disparities in rates of infant deaths and adverse maternal health outcomes. More information on this funding can be found here.
On April 4, 2022, HHS announced a new initiative in which more than 59 million Americans with Medicare Part B, including those enrolled in a Medicare Advantage (MA) plan, now have access to Food and Drug Administration (FDA) approved, authorized, or cleared over-the-counter COVID-19 tests at no cost. People with Medicare can get up to eight tests per calendar month from participating pharmacies and health care providers for the duration of the COVID-19 public health emergency. More information on this initiative can be found here.
On April 5, 2022, the Biden Administration announced a proposed rule to address the Affordable Care Act (ACA) “family glitch,” which has prevented family members from accessing federal subsidies to buy health insurance on the ACA health insurance marketplaces. The Department of Treasury’s proposed rule would allow family members of employees with affordable self-coverage and unaffordable family coverage to qualify for premium tax credits to purchase health insurance on the ACA health insurance marketplaces. The proposed rule would expand coverage to an estimated 200,000 uninsured individuals and make health insurance more affordable for an additional 1 million individuals whose coverage would otherwise cost more than 10 percent of their household income. The White House released a fact sheet with additional information on the proposed rule, which can be found here. The full text of the proposed rule can be found here.
On April 6, 2022, HHS’s Office for Civil Rights (OCR) released a Request for Information (RFI) seeking input from the public on two requirements of the Health Information Technology for Economic and Clinical Health Act of 2009 (HITECH Act), as amended in 2021. The growing number of cybersecurity threats are a significant concern driving the need for enhanced safeguards of electronic protected health information (ePHI). HHS states that this RFI will enable OCR to consider ways to support the healthcare industry’s implementation of recognized security practices. The RFI also will help OCR consider ways to share funds collected through enforcement with individuals who are harmed by violations of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Rules. More information on the RFI can be found here.
On April 7, 2022, the Centers for Medicare & Medicaid Services (CMS) issued a final Medicare national coverage determination (NCD) that covers Food and Drug Administration (FDA) approved monoclonal antibodies directed against amyloid for the treatment of Alzheimer’s disease (AD) when furnished in accordance to the Coverage Criteria specified below under coverage with evidence development (CED) for patients who have a clinical diagnosis of mild cognitive impairment (MCI) due to AD or mild AD dementia, both with confirmed presence of amyloid beta pathology consistent with AD. A fact sheet on the NCD can be found here. The full NCD can be found here.

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