United States: Alston & Bird Health Care Week In Review, January 14, 2022

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, the Supreme Court issued rulings on CMS's COVID-19 vaccination rule and OSHA's Emergency Temporary Standard. Read more about these decisions and other news below.

I. Regulations, Notices & Guidance

• On January 10, 2022, the Food and Drug Administration (FDA) issued draft guidance entitled, Notifying the Food and Drug Administration of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry and Food and Drug Administration Staff.  This guidance is intended to assist manufacturers in providing timely, informative notifications about changes in the production of certain medical device products that will help prevent or mitigate shortages of such devices during or in advance of a public health emergency. FDA is issuing this guidance to implement amendments to the Federal Food, Drug, and Cosmetic Act (FD&C Act) by the Coronavirus Aid, Relief, and Economic Security Act (CARES Act), as it relates to device shortages and potential device shortages during or in advance of a public health emergency.
• On January 12, 2022, the Centers for Medicare & Medicaid Services (CMS) issued a notice entitled, Medicare Program; Updates to Lists Related to Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Conditions of Payment.  CMS announced the updated Healthcare Common Procedure Coding System (HCPCS) codes on the Master List of DMEPOS Items Potentially Subject to Face-to-Face Encounter and Written Order Prior to Delivery and/or Prior Authorization Requirements. It also announces the initial selection of HCPCS codes on the Required Face-to-Face Encounter and Written Order Prior to Delivery List and the updates the HCPCS codes on the Required Prior Authorization List.
• On January 12, 2022, FDA issued a final rule entitled, Revised Procedures for the Announcement of Approvals and Denials of Premarket Approval Applications and Humanitarian Device Exemption Applications.  This final rule discontinues the publication in the Federal Register after each quarter of a list of PMA and HDE approvals and denials announced in that quarter. FDA will continue to post approval and denial notices for PMAs and HDEs on FDA's home page on the internet and will also continue to make available on the internet and place on public display summaries of safety and effectiveness data (SSED) for PMAs and summaries of safety and probable benefit (SSPB) for HDEs.
• On January 12, 2022, FDA issued a final rule entitled, Revocation of the Regulations for Human Tissue Intended for Transplantation and Human Dura Mater. FDA is issuing a final rule to revoke the regulations for human tissue intended for transplantation and human dura mater recovered prior to May 25, 2005. The revocation does not affect the regulations for human cells, tissues, and cellular and tissue-based products (HCT/Ps) recovered on or after May 25, 2005. The rule is being finalized because these regulations are obsolete or no longer necessary to achieve public health goals.
• On January 12, 2022, the Department of Health and Human Services (HHS) issued a final rule entitled, Acquisition Regulations: Buy Indian Act; Procedures for Contracting.  The Secretary of HHS is finalizing regulations guiding implementation of the Buy Indian Act, which provides the Indian Health Service (IHS) with authority to set-aside procurement contracts for Indian-owned and controlled businesses. This rule supplements the Federal Acquisition Regulations (FAR) and the Department of Health and Human Services Acquisition Regulations (HHSAR).

Event Notices

• January 25, 2022:  The National Institutes of Health (NIH) announced  a public meeting of the National Institute of Dental & Craniofacial Research's National Advisory Dental and Craniofacial Research Council. The meeting agenda will include a Report of the Director, NICDR, and concept clearances.
• January 31-February 1, 2022:  NIH announced a public meeting of the National Institute of Mental Health's (NIMH) National Advisory Mental Health Council. The meeting agenda will include a presentation of the NIMH Director's Report and a discussion of the NIMH program.
• February 1, 2022: NIH announced a public meeting of the National Institute of Arthritis and Musculoskeletal and Skin Diseases's National Arthritis and Musculoskeletal and Skin Diseases Advisory Council. The meeting agenda will include a discussion of program policies and skin diseases.
• February 1, 2022:  The Centers for Disease Control and Prevention (CDC) announced a public meeting of the Advisory Committee to the Director (ACD). The meeting agenda will include discussions on CDC's current work and priorities as they relate to: 1) health equity and 2) public health system infrastructure issues regarding data modernization and/or support for the public health workforce.
• February 3, 2022:  HHS announced a public inaugural meeting of the President's Advisory Commission on Asian Americans, Native Hawaiians, and Pacific Islanders. The meeting is the first in a series of federal advisory committee meetings regarding the development of recommendations to promote equity, justice, and opportunity for Asian American, Native Hawaiian, and Pacific Islander (AA and NHPI) communities.
• February 3, 2022:  CMS announced a public meeting of the Advisory Panel on Outreach and Education (APOE). The Panel advises and makes recommendations to the Secretary of the U.S. Department of Health and Human Services (HHS) (the Secretary) and the Administrator of CMS on opportunities to enhance the effectiveness of consumer education strategies concerning the Health Insurance Marketplace®, Medicare, Medicaid, and the Children's Health Insurance Program (CHIP).
• February 7-8, 2022:  NIH announced a public meeting of the National Human Genome Research Institute's National Advisory Council for Human Genome Research. The meeting agenda will include a report from the Institute Director and Institute staff.
• February 8, 2022:  NIH announced a public meeting of the National Heart, Lung, and Blood Institute's National Heart, Lung, and Blood Advisory Council. The meeting agenda will include a discussion of program policies and issues.
• February 15-16, 2022:  NIH announced a public meeting of the National Institute of Environmental Health Sciences's National Advisory Environmental Health Sciences Council. The meeting agenda will include a discussion of program policies and issues, and a Council discussion.
• February 24, 2022:  NIH announced  a public meeting of the Office of the Director's Office of AIDS Research Advisory Council (OARAC). The meeting agenda will include the OAR Director's Report; updates from the Clinical Guidelines Working Groups of OARAC; updates from NIH HIV-related advisory councils; presentation and discussions on HIV and COVID-19, and NIH-wide programs and initiatives; and public comment.
• March 10, 2022:  FDA announced a public hearing on scientific data and information related to the residue of carcinogenic concern for the new animal drug carbadox, a carcinogenic new animal drug used in swine feed.
• Various Dates:  The Federal Emergency Management Agency announced a series of meetings, under the Plan of Action to Establish a National Strategy for the Manufacture, Allocation, and Distribution of Medical Gases to Respond to COVID-19, to implement the Voluntary Agreement for the Manufacture and Distribution of Critical Healthcare Resources Necessary to Respond to a Pandemic.

II. Congressional Hearings

U.S. Senate

• On January 11, 2022, the Senate Committee on Health, Education, Labor and Pensions (HELP) held a hearing entitled, Addressing New Variants: A Federal Perspective on the COVID-19 Response.  Witnesses present included: Rochelle Walensky, MD, MPH, Director, United States Centers for Disease Control and Prevention; Anthony Fauci, MD, Director, National Institute of Allergy and Infectious Diseases, National Institutes of Health; Janet Woodcock, MD, Acting Commissioner, United States Food and Drug Administration; and Dawn O'Connell, Assistant Secretary for Preparedness and Response, United States Department of Health and Human Services.
• On January 12, 2022, the Senate HELP Committee held an executive session on Various Nominations, including the nomination of Robert Califf to be Commissioner of Food and Drugs, Food and Drug Administration, Department of Health and Human Services. The Committee supported Dr. Califf by a vote of 13-8, with six Republicans and two Democrats opposed to his confirmation.

III. Reports, Studies & Analyses

• On January 10, 2022, the Government Accountability Office (GAO) published a report entitled, Opioid Use Disorder: Opportunities to Improve Assessments of State Opioid Response Grant Program. The State Opioid Response (SOR) grant program provides grants to help address the negative effects of the opioid crisis, including overdose deaths. Through the program, the Substance Abuse and Mental Health Services Administration (SAMHSA) has awarded nearly $5.2 billion since 2018 to states, the District of Columbia, and U.S. territories for opioid-use disorder (OUD) prevention, treatment, and recovery support services. This report examines how SAMHSA assesses the grant program, among other things.
• On January 13, 2022, the Congressional Budget Office (CBO) published a presentation entitled, CBO's Model of New Drug Development. Chris Adams, an analyst in CBO's Health Analysis Division, described CBO's model of new drug development, which is intended to help the Congress understand the effect that legislative proposals would have on the development of new drugs. CBO uses the model to produce alternatives to elasticity estimates presented in the literature.

IV. Other Health Policy News

• On January 10, 2022, the Biden-Harris Administration announced it is requiring insurance companies and group health plans to cover the cost of over-the-counter, at-home COVID-19 tests, so people with private health coverage can get them for free starting January 15th. The new coverage requirement means that most consumers with private health coverage can go online or to a pharmacy or store, buy a test, and either get it paid for up front by their health plan, or get reimbursed for the cost by submitting a claim to their plan. This requirement incentivizes insurers to cover these costs up front and ensures individuals do not need an order from their health care provider to access these tests for free. More information on this requirement can be found here.
• On January 10, 2022, HHS announced that HRSA has updated comprehensive preventive care and screening guidelines for women and for infants, children, and adolescents. Under the Affordable Care Act (ACA), certain group health plans and insurance issuers must provide coverage with no out-of-pocket cost for preventive health services within these HRSA-supported comprehensive guidelines. Among a number of updates, for the first time the guidelines will require such group health plans and insurance plans to provide coverage without a co-pay or deductible for double electric breast pumps. HHS is also releasing a new report from the Office of the Assistant Secretary for Planning and Evaluation (ASPE) highlighting how the ACA has increased access to preventive care for millions of Americans, including vaccinations, contraception, and cancer screening. The ASPE report estimates that more than 150 million people with private insurance, including 58 million women and 37 million children, are receiving preventive services with no cost-sharing, as required by the ACA. More information on this announcement can be found here.
• On January 11, 2022, CMS released a proposed National Coverage Determination (NCD) decision memorandum for monoclonal antibodies directed against amyloid for the treatment of Alzheimer's disease. The proposed National Coverage Determination would cover FDA-approved monoclonal antibodies that target amyloid for the treatment of Alzheimer's disease through coverage with evidence development (CED) – which means that FDA-approved drugs in this class would be covered for people with Medicare only if they are enrolled in qualifying clinical trials. Note that Aduhelm™ (aducanumab) is currently the only monoclonal antibody directed against amyloid beta approved by the FDA for the treatment of Alzheimer's disease. The proposed National Coverage Determination is open to public comment for 30 days. More information on this action can be found here.
• On January 13, 2022, CMS Administrator Chiquita Brooks-LaSure issued a statement on the U.S. Supreme Court's decisions on CMS's vaccination standard rule and the Occupational Safety and Health Administration (OSHA) Emergency Temporary Standar The Supreme Court issued an 5-4 opinion upholding the Centers for Medicare & Medicaid Services (CMS) COVID-19 Health Care Staff Vaccination interim final rule with comment period (IFC), acknowledging that the rule aligns with the Department of Health and Human Services (HHS) mission to protect patient safety and health. The Supreme Court also issued an opinion blocking the Biden Administration from enforcing its Occupational Safety and Health Administration (OSHA) Emergency Temporary Standard (ETS) on employee COVID-19 vaccination and testing requirements for employers with 100 or more employees. More information on these actions can be found here.
• On January 14, 2022, as a result of the continued consequences of the Coronavirus Disease 2019 (COVID-19) pandemic, HHS Secretary Xavier Becerra renewed the determination that a that a public health emergency exists and has existed since January 27, 2020, nationwide. More information on this action can be found here.

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