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 Inflation Reduction Act (IRA) of 2022 became law, FDA issued a final rule on over-the-counter (OTC) hearing aids, and CMS issued a proposed rule for mandatory Medicaid and CHIP reporting requirements. Read more about these actions and other news below.

I. Regulations, Notices & Guidance

• On August 16, 2022, the Food and Drug Administration (FDA) issued final guidance entitled, Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products; Guidance for Industry and Food and Drug Administration Staff; Availability. This guidance is intended to define hearing aids, personal sound amplification products (PSAPs), their respective intended uses, and the regulatory requirements that apply to these products. FDA took this action because the FDA Reauthorization Act of 2017 (FDARA) directed FDA to update and finalize the draft guidance entitled, Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products, issued on November 7, 2013.
• On August 16, 2022, FDA issued a final rule entitled, Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the-Counter Hearing Aids. FDA is establishing a regulatory category for over-the-counter (OTC) hearing aids and making related amendments to update the regulatory framework for hearing aids. Specifically, FDA defines OTC hearing aids and establishes applicable requirements; amends existing rules for consistency with the new OTC category; repeals the conditions for sale applicable to hearing aids; amends the existing labeling requirements for hearing aids; and updates regulations relating to decisions on applications for exemption from federal preemption that will become obsolete as a result of changes to the hearing aid requirements. In creating a regulatory category for OTC hearing aids and amending existing rules, FDA intends to provide reasonable assurance of safety and effectiveness for these devices as well as foster access to, and innovation in, hearing aid technology, thereby protecting and promoting the public health.
• On August 16, 2022, FDA issued draft guidance entitled, Hydrogen Peroxide-Based Contact Lens Care Products: Consumer Labeling Recommendations--Premarket Notification (510(k)) Submissions; Draft Guidance for Industry and Food and Drug Administration Staff; Availability. FDA is issuing this draft guidance to provide labeling recommendations for hydrogen peroxide-based contact lens care products (HPCPs) submitted in premarket notification (510(k)) submissions. The labeling recommendations in this draft guidance are intended to promote the safe and effective use of HPCPs and ensure that consumers receive and understand information regarding the benefits and risks associated with the use of the device.
• On August 16, 2022, FDA issued final guidance entitled, Replacement Reagent and Instrument Family Policy for In Vitro Diagnostic Devices; Guidance for Industry and Food and Drug Administration Staff; Availability. This guidance is intended to update and provide clarity on the replacement reagent and instrument family policy for manufacturers of in vitro diagnostic devices and FDA staff to promote consistent application of the concepts in this guidance. Specifically, it addresses a manufacturer’s application of an assay that was previously cleared for use based on performance characteristics when used with a specified instrument to an additional instrument that was previously cleared, or that is a member of an instrument family from which another member has been previously cleared.
• On August 17, 2022, the National Institutes of Health (NIH) issued a notice entitled, Government-Owned Inventions; Availability for Licensing. The National Institute of Allergy and Infectious Diseases (NIAID) has developed a method of treatment for COVID-19-induced lung fibrosis using nebulized thrombin inhibitors. This innovative technology addresses the pathology of virus-induced lung fibrosis at the proper location instead of indiscriminately. This technology is available for licensing for commercial development.
• On August 18, 2022, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule entitled, Medicaid Program and CHIP; Mandatory Medicaid and Children’s Health Insurance Program (CHIP) Core Set Reporting. This proposed rule would establish the requirements for mandatory annual state reporting of the Core Set of Children’s Health Care Quality Measures for Medicaid and CHIP, the behavioral health measures on the Core Set of Adult Health Care Quality Measures for Medicaid, and the Core Sets of Health Home Quality Measures for Medicaid. This proposed rule would also establish compliance requirements.
• On August 19, 2022, the Centers for Disease Control and Prevention (CDC) issued a notice entitled, Solicitation of Nominations for Appointment to the Board of Scientific Counselors, National Center for Health Statistics (BSC, NCHS). BSC, NCHS consists of up to 15 experts, including the Chair, in fields associated with statistical, demographic, and epidemiological research. Nominations are being sought for individuals who have the expertise and qualifications necessary to contribute to the accomplishment of the Board’s objective to provide advice and guidance on statistical and epidemiological research, data collection, and activities that support NCHS. Nominations for membership in BSC, NCHS must be received no later than October 14, 2022.

Event Notices

• September 12, 2022: NIH announced a public meeting of NIAID’s AIDS Research Advisory Committee. The agenda will include a report from the Division Director and staff.
• September 12, 2022: NIH announced a public meeting of NIAID’s National Advisory Allergy and Infectious Diseases Council. The open portions of the meeting will include reports from the NIAID Director, the Division Director, and Division staff.
• September 12-13, 2022: NIH announced a public meeting of the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) National Advisory Child Health and Human Development (NACHHD) Council. The open portion of the meeting will include opening remarks, a discussion of administrative matters, the NICHD Director’s report, and other business of the Council.
• September 13, 2022: NIH announced a public meeting of the National Institute on Drug Abuse (NIDA) National Advisory Council on Drug Abuse (NACDA). The open portion of the meeting will include presentations and other NACDA business.
• September 13, 2022: NIH announced a public meeting of the National Institute of Dental and Craniofacial Research (NIDCR) National Advisory Dental and Craniofacial Research Council. The open portion of the meeting will include a report from the NIDCR Director and concept clearances.
• September 13, 2022: NIH announced a public meeting of the National Heart, Lung, and Blood Institute (NHLBI) National Heart, Lung, and Blood Advisory Council. The meeting agenda will include a discussion of program policies and issues.
• September 14, 2022: NIH announced a public meeting of the National Arthritis and Musculoskeletal and Skin Diseases (NIAMS) Advisory Council. The open portion of the meeting will include a discussion of program policies and issues, as well as a report from BSC, NIAMS.
• September 19-20, 2022: The Department of Health and Human Services (HHS) announced a public meeting of the Presidential Advisory Council on HIV/AIDS (PACHA). The meeting agenda will include PACHA providing advice, information, and recommendations to the HHS Secretary regarding programs and policies intended to promote effective HIV diagnosis, treatment, prevention, and quality care services.
• September 28, 2022: HHS announced a public meeting of the President’s Advisory Commission on Asian Americans, Native Hawaiians, and Pacific Islanders. The meeting agenda will include a discussion regarding the development of recommendations to promote equity, justice, and opportunity for Asian American, Native Hawaiian, and Pacific Islander (AA and NHPI) communities.
• September 29, 2022: CDC announced a public meeting of the Advisory Board on Radiation and Worker Health (ABRWH), Subcommittee for Procedures Reviews (SPR). The agenda will include discussions on the following: a) technical guidance documents related to: Texas City Chemicals, Weldon Spring Plant, Birdsboro Steel and Foundry Company, Grand Junction Facilities, Peek Street Facility, dose reconstruction default assumptions and methods, and template dose reconstruction methodologies; (b) preparation for the December 2022 full ABRWH meeting; and (c) newly issued guidance documents and supplemental topics.
• October 4, 2022: CDC announced a public meeting of the Board of Scientific Counselors, National Institute for Occupational Safety and Health (BSC, NIOSH). The agenda for the meeting will include health communications and updates from the National Firefighter Registry Subcommittee, as well as discussions about the progress of the NIOSH Evaluation Capacity Building Plan and implementation science.
• October 6, 2022: FDA announced a public meeting of the Vaccines and Related Biological Products Advisory Committee (VRBPAC). This meeting will be held to discuss the strain selection for the influenza virus vaccines for the 2023 Southern Hemisphere Influenza Season.
• November 2-3, 2022: The Health Resources and Services Administration (HRSA) announced a public meeting of the HHS Secretary’s National Advisory Council on Migrant Health (NACMH). The meeting agenda will include a discussion of topics related to migratory and seasonal agricultural worker health.

II. Reports, Studies & Analyses

• On August 16, 2022, the HHS Office of the Inspector General (OIG) published a report entitled, The National Institutes of Health Did Not Ensure That All Clinical Trial Results Were Reported in Accordance With Federal Requirements. OIG’s objective in this report was to determine whether NIH ensured that NIH-funded Intramural and Extramural clinical trials complied with federal reporting requirements. NIH reviewed all 72 NIH-funded Intramural and Extramural clinical trials for which federal law and NIH policy required the results to be reported in calendar year (CY) 2019 or 2020. Following their review, OIG found that NIH did not ensure that all NIH-funded Intramural and Extramural clinical trials complied with federal reporting requirements for responsible parties to submit the results of clinical trials.
• On August 17, 2022, the Kaiser Family Foundation (KFF) published a report entitled, Key Facts About Medicare Part D Enrollment and Costs in 2022. This report provides the latest data about Medicare Part D enrollment and costs in 2022, and trends over time, based on data from CMS. Analysis found that in 2022, more than half of all Part D enrollees (53 percent, or 25.8 million) are enrolled in Medicare Advantage Prescription Drug Plans (MA-PDs) and 47 percent (23.1 million) are enrolled in stand-alone Prescription Drug Plans (PDPs)—the first year that MA-PD enrollment has surpassed PDP enrollment.
• On August 17, 2022, the Government Accountability Office (GAO) published a report entitled, Public Health Preparedness: COVID-19 Medical Surge Experiences and Related HHS Efforts. This report describes: (1) medical surge challenges selected hospitals faced in responding to the COVID-19 pandemic and how health care coalitions have supported their efforts, and (2) selected HHS programs and activities underway to support medical surge readiness. All hospitals in this review reported staffing challenges, such as a lack of staff to care for the increase in sick patients or staff becoming ill and unable to work, affecting hospital services. HHS has programs and activities underway intended to support medical surge readiness for hospitals and other health care organizations, but GAO concluded that it is too soon to know the effectiveness of these efforts.
• On August 18, 2022, KFF published a report entitled, Mental Health Parity at a Crossroads. This report explains the federal behavioral health parity requirements – including who they apply to and how they are enforced — and sets out key policy issues. This report addresses the consistent calls for more federal guidance on the specific protections in the federal behavioral health parity law, as well as for increased enforcement. KFF found key future parity policy issues to be the simplification of standards, a needed assessment of medical management criteria, an evaluation of enforcement tools, and an examination of how parity can address network adequacy challenges.
• On August 18, 2022, KFF published a report entitled, How Will the Prescription Drug Provisions in the Inflation Reduction Act Affect Medicare Beneficiaries? This report examines the potential impact of the Inflation Reduction Act’s (IRAs) prescription drug provisions for Medicare beneficiaries nationally and by state. KFF examines the bill’s provisions to lower drug prices, which include a requirement that the federal government negotiate prices for some high-cost drugs covered under Medicare and that drug manufacturers pay rebates to Medicare if they increase prices faster than inflation for drugs used by Medicare beneficiaries. The report also breaks down the number of Medicare beneficiaries who may be affected by prescription drug provisions in the bill by state.

III. Other Health Policy News

• On August 16, 2022, President Biden signed the Inflation Reduction Act (IRA) of 2022 into law. The signing came after the Senate passed the bill by a vote of 51-50 on August 7 and the House of Representatives passed the bill by a vote of 220 to 207 on August 12. The bill is expected to raise approximately $740 in revenue, with $430 billion going towards new spending and $300 billion going towards deficit reduction. Among the health provisions, the bill will extend Affordable Care Act (ACA) Marketplace premium assistance subsidies that were enhanced by the American Rescue Plan (ARP) Act for three additional years, cap Medicare beneficiary out-of-pocket costs for insulin at $35 per month, cap Medicare Part D beneficiary out-of-pocket costs at $2,000 annually, and require Medicare to negotiate directly with manufacturers for the price of prescription drugs starting in 2023. More information on this action can be found here.
• On August 16, 2022, HHS announced that it had approved the extension of Medicaid and CHIP coverage for 12 months after pregnancy in Hawaii, Maryland, and Ohio. As a result, an additional 34,000 people annually, across the three states, will now be eligible for Medicaid or Title XXI-funded Medicaid expansion CHIP coverage for a full year after pregnancy. An estimated 318,000 Americans in 21 states and D.C. are now eligible for 12 months of postpartum coverage following the announcement. More information on this announcement can be found here.
• On August 18, 2022, HHS announced three actions that it said will strengthen and expand access to high-quality, comprehensive health care for children across the country. The actions are in line with the Biden Administration’s focus on addressing the nation’s mental health crisis. First, HHS issued a new guidance document reminding states of their mandate to cover behavioral health services for children in Medicaid and urged states to leverage every resource to strengthen mental health care for children. HHS is issuing a second guidance document that urges states to expand school-based health care for children, including mental health care. Third, HHS issued a proposed rule that would require states to report certain quality measures to strengthen Medicaid and CHIP. More information on these actions can be found here.
• On August 18, 2022, CMS announced it will be discontinuing the use of Certificates of Medical Necessity (CMNs) and Durable Medical Equipment (DME) Information Forms (DIFs) for DME claims with dates of service on or after January 1, 2023. CMS suppliers must continue to submit CMN and/or DIF information for claims with dates of service before January 1, 2023 if it is required. This action is part of CMS’ ongoing efforts to increase access to care and to reduce unnecessary administrative burden for stakeholders. CMS is also aiming to enable frontline clinicians to focus on providing direct care and streamline the coverage process for suppliers. More information on this action can be found here.

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