Alston & Bird Health Care Week in Review - January 2022 #3

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, HHS awarded $103 million to address mental health in the health care workforce and $13 million to increase access to behavioral health care services in rural America. Read more about these funds and other news below.

I. Regulations, Notices & Guidance

• On January 18, 2022, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule entitled, Clinical Laboratory Improvement Amendments of 1988 (CLIA) Proficiency Testing Regulations Related to Analytes and Acceptable Performance; Extension of Timeline for Publication of Final Rule. The Social Security Act specifies that a Medicare final rule must be published no later than 3 years after the publication date of the proposed rule or interim final rule, as applicable, except under exceptional circumstances. In accordance with the Act, this document announces an extension of the timeline for publication of the final rule and includes a brief explanation of the justification for the variation.
• On January 20, 2022, the Food and Drug Administration (FDA) issued a final rule entitled, Medical Devices; Ophthalmic Devices; Classification of the Retinal Diagnostic Software Device. FDA is classifying the retinal diagnostic software device 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 retinal diagnostic software device’s classification.
• On January 20, 2022, FDA issued a proposed rule entitled, Medical Devices; Immunology and Microbiology Devices; Classification of Human Leukocyte, Neutrophil and Platelet Antigen and Antibody Tests. FDA is proposing to classify Human Leukocyte Antigen (HLA), Human Platelet Antigen (HPA), and Human Neutrophil Antigen (HNA) devices, a generic type of device, into class II (special controls). FDA is identifying proposed special controls for HLA, HPA, and HNA devices that are necessary to provide a reasonable assurance of safety and effectiveness. FDA does not intend to exempt these device types from premarket notification requirements of the Federal Food, Drug, and Cosmetic Act (FD&C Act). FDA is publishing in this document the recommendations of the Blood Products Advisory Committee, serving as a device classification panel, regarding the classification of these devices. After considering public comments on the proposed classification, FDA will publish a final regulation classifying these device types.
• On January 20, 2022, FDA issued draft guidance entitled, Collecting and Providing 702(b) Portions of Food and Drug Administration Official Samples--Questions and Answers. This draft guidance is intended to assist industry and FDA staff with issues and questions related to the requirements for FDA to collect and provide a part of an official sample of an article to any person named on the label of the article, or the owner thereof, or his attorney or agent.
• On January 20, 2022, FDA issued a notice of availability entitled, Guidance Documents Related to Coronavirus Disease 2019. The guidances identified in this notice address issues related to the COVID-19 PHE and have been issued in accordance with the process announced in the March 25, 2020, notice. The guidances have been implemented without prior comment, but they remain subject to comment in accordance with the Agency’s good guidance practices.
• On January 20, 2022, the Department of Health and Human Services (HHS) issued a notice entitled, Annual Update of the HHS Poverty Guidelines. This notice provides an update of the HHS poverty guidelines to account for last calendar year’s increase in prices as measured by the Consumer Price Index.
• On January 21, 2022, HHS’s Office of the National Coordinator for Health Information Technology (ONC) issued a Request for Information (RFI) entitled, Request for Information: Electronic Prior Authorization Standards, Implementation Specifications, and Certification Criteria. This RFI seeks input from the public regarding electronic prior authorization standards, implementation specifications, and certification criteria that could be adopted within the ONC Health IT Certification Program. Responses to this RFI will be used to inform potential future rulemaking.

Event Notices

• February 10-11, 2022: The Health Resources and Services Administration (HRSA) announced a public meeting of the Advisory Committee on Heritable Disorders in Newborns and Children (ACHDNC). ACHDNC provides advice and recommendations to the Secretary of Health and Human Services (Secretary) on the development of newborn screening activities, technologies, policies, guidelines, and programs for effectively reducing morbidity and mortality in newborns and children having, or at risk for, heritable disorders. The ACHDNC reviews and reports regularly on newborn and childhood screening practices.
• February 10-11, 2022: HHS announced a public meeting of the National Vaccine Advisory Committee (NVAC). The NVAC was established to provide advice and make recommendations to the Director of the National Vaccine Program on matters related to the Program’s responsibilities. The Assistant Secretary for Health serves as Director of the National Vaccine Program.
• February 17, 2022: HHS announced the inaugural public meeting of the National Advisory Committee on Children and Disasters (NACCD). The NACCD shall evaluate issues and programs and provide findings, advice, and recommendations to the Secretary of HHS to support and enhance all-hazards public health and medical preparedness, response, and recovery aimed at meeting the unique needs of children and their families across the entire spectrum of their wellbeing.
• February 28-March 1, 2022: HHS announced a public meeting of the Tick-Borne Disease Working Group (TBDWG). In this meeting, the TBDWG will (1) hear presentations from six subcommittees on findings and potential actions from reports prepared for the TBDWG to consider and (2) further discuss plans for developing the next report to the HHS Secretary and Congress on federal tick-borne activities and research, taking into consideration the 2018 and 2020 report. The 2022 report will address a wide range of topics related to tick-borne diseases, such as, surveillance, prevention, diagnosis, diagnostics, and treatment; identify advances made in research, as well as overlap and gaps in tick-borne disease research; and provide recommendations regarding any appropriate changes or improvements to such activities and research.
• March 8-9, 2022: The Centers for Disease Control and Prevention (CDC) announced a public meeting of the National Center for Health Statistics (NCHS), ICD-10 Coordination and Maintenance (C&M) Committee. The ICD-10 Coordination and Maintenance (C&M) Committee is a public forum for the presentation of proposed modifications to the International Classification of Diseases, Tenth Revision, Clinical Modification and ICD-10 Procedure Coding System.

II. Congressional Hearings

U.S. House of Representatives

• On January 19, 2022, the House Committee on Rules Subcommittee on Legislative and Budget Process held a hearing entitled, Using Budget Principles to Prepare for Future Pandemics and Other Disasters. Witnesses present included: Ms. Julia Tedesco, President & CEO, Foodlink, Inc.; Dr. Helene Gayle, CEO, Chicago Community Trust; Mr. Jeff Schlegelmilch, Director, National Center for Disaster Preparedness at Columbia Climate School; and The Honorable Robert Kadlec, Former Assistant Secretary for Preparedness and Response, HHS.
• On January 20, 2022, the House Select Subcommittee on the Coronavirus Crisis held a hearing entitled, A View from the States: Governors Respond to the Omicron Variant. Witnesses present included: Governor Jay Inslee, State of Washington; Governor Jared Polis, State of Colorado; Governor Pedro Pierluisi, Commonwealth of Puerto Rico; and Mayor Muriel Bowser, District of Columbia.

III. Reports, Studies & Analyses

• On January 19, 2022, the Government Accountability Office (GAO) published a report entitled, COVID-19: HHS and DOD Transitioned Vaccine Responsibilities to HHS, but Need to Address Outstanding Issues. Since May 2020, federal efforts to speed the development, manufacturing, and distribution of COVID-19 vaccines—previously known as Operation Warp Speed—have been led by the Departments of Health and Human Services and Defense. HHS took over sole responsibility for the work at the beginning of 2022. The report found that it is unclear whether HHS is ready to fully assume all responsibilities, especially those formerly led by DOD. HHS has assessed its workforce capabilities, but it has not addressed the loss of DOD officials with specialized skills.
• On January 19, 2022, the Congressional Budget Office (CBO) published a report entitled, Prescription Drugs: Spending, Use, and Prices. In recent years, policymakers have expressed concerns about the high prices of prescription drugs. Those drugs offer wide-ranging benefits, such as reducing the need for services provided by physicians and hospitals, improving the quality of life, and extending life. However, high prices reduce consumers’ access to such medications. They also contribute to higher spending that strains budgets, including the federal budget. In this report, the CBO examines trends in nationwide spending on prescription drugs over the 1980–2018 period. The report also provides a more detailed analysis of trends in spending, use, and prices in the Medicare Part D and Medicaid programs over the 2009–2018 period.
• On January 20, 2022, CBO published a report entitled, The Prices That Commercial Health Insurers and Medicare Pay for Hospitals’ and Physicians’ Services. In this report, CBO examined potential reasons that the prices paid by commercial health insurers for hospitals’ and physicians’ services are higher, rise more quickly, and vary more by area than the prices paid by the Medicare fee-for-service program.
• On January 20, 2022, Alston & Bird published the latest edition of Healthy Byte: What Is TEFCA and How Will It Advance Interoperability?. HHS ONC released the Trusted Exchange Framework and Common Agreement (TEFCA), a critical step in facilitating nationwide data exchange. Elinor Hiller and JP Paluskiewicz from Alston & Bird discuss the nonbinding principles under the Trusted Exchange Framework, the universal floor for interoperability via the Common Agreement, how we got here, and what to expect next.
• On January 21, 2022, the Kaiser Family Foundation (KFF) published an issue brief entitled, The Intersection of Medicaid, Special Education Service Delivery, and the COVID-19 Pandemic. This brief describes how Medicaid and special education services work in meeting children’s needs, explores how the pandemic has affected children who receive special education services, and identifies key issues to watch moving forward.

IV. Other Health Policy News

• On January 18, 2022, HHS’s ONC and its Recognized Coordinating Entity (RCE), The Sequoia Project, Inc., announced the publication of the Trusted Exchange Framework and the Common Agreement (TEFCA). Entities will soon be able to apply and be designated as Qualified Health Information Networks (QHINs). QHINs will connect to one another and enable their participants to engage in health information exchange across the country. More information on this announcement can be found here.
• On January 18, 2022, HHS announced the availability of $13 million in funding to increase access to behavioral health care services and address health inequities in rural America, including through evidence-based, trauma-informed treatment for substance use disorder. HRSA’s Federal Office of Rural Health Policy will make awards through the Rural Communities Opioid Response Program (RCORP) - Behavioral Health Care Support. More information on these funds can be found here.
• On January 20, 2022, HHS, through HRSA, announced $103 million in awards to improve the retention of health care workers and help respond to the nation’s critical staffing needs by reducing burnout and promoting mental health and wellness among the health care workforce. These awards will fund evidence-informed programs, practices, and training, with a specific focus on providers in underserved and rural communities. The funds, secured through the Biden-Harris Administration’s American Rescue Plan, will be disbursed to 45 grantees. More information on these funds can be found here.

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