Alston & Bird Health Care Week in Review, October 15, 2021

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 Department of Health and Human Services announced $100 million in American Rescue Plan funding for state programs supporting primary health care workers in underserved communities. Read more about this funding and other news below.

I. Regulations, Notices & Guidance

• On October 12, 2021, the Food and Drug Administration (FDA) issued a notice entitled, Alcohol-Based Hand Sanitizer Products; Withdrawal of Three Temporary Guidance Documents Issued During the Public Health Emergency of the Coronavirus Disease 2019. FDA announced the withdrawal of three guidance documents entitled, Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19), Policy for Temporary Compounding of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency, and Temporary Policy for Manufacture of Alcohol for Incorporation Into Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19. FDA is withdrawing these three guidance documents because current data indicate that consumers and healthcare personnel are no longer experiencing difficulties accessing alcohol-based hand sanitizer products, and these temporary policies are no longer needed to help meet demand for alcohol-based hand sanitizer products or for alcohol for use in alcohol-based hand sanitizer.
• On October 13, 2021, the Department of Health and Human Services (HHS) issued a proposed rule entitled, Acquisition Regulation - Electronic Submission and Processing of Payment Requests. HHS is proposing to amend HHS’s Federal Acquisition Regulation Supplement, the HHS Acquisition Regulation (HHSAR), to support the HHS Electronic Invoicing Implementation Project and HHS’s transition to the Department of the Treasury’s Invoice Processing Platform.
• On October 13, 2021, FDA issued final guidance entitled, Voluntary Sodium Reduction Goals: Target Mean and Upper Bound Concentrations for Sodium in Commercially Processed, Packaged, and Prepared Foods. The guidance describes our views on voluntary short-term (2.5-year) goals for sodium reduction in a variety of identified categories of foods that are commercially processed, packaged, or prepared. These goals are intended to address the excessive intake of sodium in the current population and promote improvements in public health.
• On October 13, 2021, FDA issued draft guidance entitled, Select Updates for Unique Device Identification: Policy Regarding Global Unique Device Identification Database Requirements for Certain Devices. This draft guidance explains that there are certain class I devices for which FDA does not intend to enforce Global Unique Device Identification Database (GUDID) submission requirements and describes how a labeler of a class I device can determine if its device is one of these devices in the revised section III of this draft guidance. When this draft guidance is finalized, the updates in section III of this draft guidance would supersede the recommendations in section III of the guidance entitled, Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices and Certain Devices Requiring Direct Marking.
• On October 13, 2021, FDA issued draft guidance entitled, Q13 Continuous Manufacturing of Drug Substances and Drug Products. The draft guidance was prepared under the auspices of the International Council for Harmonisation (ICH). The draft guidance provides clarification on continuous manufacturing (CM) concepts and describes scientific approaches and regulatory considerations specific to CM of drug substances and drug products. The draft guidance is intended to provide scientific and regulatory considerations for the development, implementation, operation, and lifecycle management of CM.
• On October 15, 2021, the Drug Enforcement Agency (DEA) issued a notice with a request for comments entitled, Proposed Aggregate Production Quotas for Schedule I and II Controlled Substances and Assessment of Annual Needs for the List I Chemicals Ephedrine, Pseudoephedrine, and Phenylpropanolamine for 2022. DEA proposes to establish the 2022 aggregate production quotas for controlled substances in schedules I and II of the Controlled Substances Act (CSA) and the assessment of annual needs for the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine.

Event Notices

• October 19-21, 2021: The National Institutes of Health (NIH) announced a public meeting of the National Institute on Aging’s Board of Scientific Counselors. The meeting will review and evaluate personnel qualifications and performance, and competence of individual investigators and hear a Committee discussion, individual presentations, and laboratory overview.
• October 26, 2021: FDA announced a public advisory committee meeting of the Vaccines and Related Biological Products Advisory Committee (VRBPAC). The general function of the committee is to provide advice and recommendations to FDA on regulatory issues.
• October 26-27, 2021: HHS announced a public meeting of the Secretary’s Advisory Committee on Human Research Protections (SACHRP). SACHRP was established to provide expert advice and recommendations to the Secretary of Health and Human Services, through the Assistant Secretary for Health, on issues and topics pertaining to or associated with the protection of human research subjects.
• October 28, 2021: HHS announced a public meeting of the COVID-19 Health Equity Task Force. The purpose of this meeting is to present and vote on the Task Force Final Report with recommended Implementation Plan and Accountability Plan for mitigating inequities caused or exacerbated by the COVID-19 pandemic and for preventing such inequities in the future.
• November 8-9, 2021: The Office of Workers’ Compensation Programs (OWCP) announced a public meeting of the Advisory Board on Toxic Substances and Worker Health for the Energy Employees Occupational Illness Compensation Program Act (EEOICPA). The purpose of the Advisory Board is to advise the Secretary with respect to: 1) the Site Exposure Matrices (SEM) of the Department of Labor; 2) medical guidance for claims examiners for claims with the EEOICPA program, with respect to the weighing of the medical evidence of claimants; 3) evidentiary requirements for claims under Part B of EEOICPA related to lung disease; 4) the work of industrial hygienists and staff physicians and consulting physicians of the Department of Labor and reports of such hygienists and physicians to ensure quality, objectivity, and consistency; 5) the claims adjudication process generally, including review of procedure manual changes prior to incorporation into the manual and claims for medical benefits; and 6) such other matters as the Secretary considers appropriate.
• November 16, 2021: FDA announced a virtual public meeting entitled, Enhanced Drug Distribution Security at the Package Level Under the Drug Supply Chain Security Act (DSCSA). This public meeting is intended to provide members of the pharmaceutical distribution supply chain and other interested stakeholders an opportunity to discuss enhanced drug distribution security requirements of the DSCSA related to system attributes necessary to enable secure tracing of product at the package level.
• December 8-9, 2021: The Centers for Disease Control and Prevention (CDC) announced a public meeting for the Mine Safety and Health Research Advisory Committee (MSHRAC). This committee is charged with providing advice to the Secretary, Department of Health and Human Services; the Director, CDC; and the Director, NIOSH, on priorities in mine safety and health research, including grants and contracts for such research.

II. Congressional Hearings

U.S. House of Representatives

• On October 14, 2021, the House Committee on Energy & Commerce Subcommittee on Consumer Protection and Commerce held a hearing entitled, Investing in American Jobs: Legislation to Strengthen Manufacturing and Competitiveness. Witnesses present included: Caolionn O'Connell, Ph.D., Senior Physical Scientist, RAND Corporation; Scott Paul, President, Alliance for American Manufacturing; Eric Sills, CEO, Standard Motor Products; and Scott Lincicome, Senior Fellow, Economic Studies, CATO Institute. The hearing discussed the following legislation:
  • R. 2907, the Global Investment in American Jobs Act;
  • R. 3774, the Advancing Gig Economy Act;
  • R. 4594, the Restoring Brand USA Act;
  • R. 5474, the Reinforcing American-Made Products Act;
  • R. 5476, the Advancing Tech Startups Act;
  • R. 5479, the Supply Chain Health and Integrity for the Nation Act;
  • R. 5492, the Manufacturing Economy and National Security Act;
  • R. 5495, the Building Resilient Supply Chains Act;
  • R. 5502, the Integrity, Notification, and Fairness in Online Retail Marketplaces for Consumers Act; and
  • R. 5505, the Supply Chain Security and Resilience Act.

III. Reports, Studies & Analyses

• On October 12, 2021, the RAND Corporation published a report entitled, Going to the Doctor: Rideshare as Nonemergency Medical Transportation. This report builds on existing research on health care access to describe nonemergency medical transportation (NEMT) challenges that rideshare-based NEMT (RB-NEMT) may address for those who need NEMT by identifying rider and ride types most appropriate for RB-NEMT. The report found that RB-NEMT could help reduce system strain and satisfy an unmet or poorly met need for on-demand cost-effective solutions within the NEMT ecosystem.
• On October 13, 2021, the Kaiser Family Foundation (KFF) published an issue brief entitled, Seven in Ten Medicare Beneficiaries Did Not Compare Plans During Past Open Enrollment Period. KFF found that in 2019, 71 percent of all Medicare beneficiaries reported that they did not compare their plan to other Medicare plans that were available during the 2018 open enrollment period, while 29 percent of all Medicare beneficiaries reported that they compared Medicare plans. Among beneficiaries in Medicare Advantage plans, 68 percent reported that they did not compare Medicare plans during the 2018 open enrollment period, compared to 73 percent of those in traditional Medicare.
• On October 13, 2021, the Congressional Budget Office (CBO) published a presentation by Phillip Swagel, Director of CBO, which outlined the agency’s budget and economic analysis during the 2020–2021 coronavirus pandemic and described some of the challenges involved in analyzing current economic policy. Mr. Swagel’s remarks focused on CBO’s analysis of health policy, the macroeconomic effects of the legislative response to the pandemic, and labor market issues arising from the response and recovery. He also discussed the long-term effects of the recovery on economic growth, jobs, wages, productivity, and climate change. More information on this presentation can be found here.
• On October 14, 2021, the HHS Office of Inspector General (OIG) published a report entitled, Changes Made to States' Medicaid Programs To Ensure Beneficiary Access to Prescriptions During the COVID-19 Pandemic. The report’s objective was to identify actions that selected States took or planned to take to ensure that Medicaid beneficiaries continued to receive prescription drugs during the COVID-19 pandemic. OIG found that most States had implemented changes to ease restrictions on prior authorizations and early refill requirements, made changes to their prescription quantity limits to allow pharmacies to dispense increased quantities of some prescription drugs, and removed the requirement of obtaining a signature upon receipt of a prescription.
• On October 14, 2021, HHS OIG published a report entitled, S. Department of Health and Human Services Met the Requirements of the Digital Accountability and Transparency Act of 2014, With Areas That Require Improvement. OIG’s performance audit determined that HHS implemented and used Government-wide financial data standards and complied with the reporting requirements of the Digital Accountability and Transparency Act of 2014 (DATA Act) as stipulated by the Office of Management and Budget (OMB) and the Department of Treasury. HHS's overall data quality earned a rating of excellent based on the areas tested, indicating that HHS's data was generally reliable.
• On October 14, 2021, the Government Accountability Office (GAO) published a report entitled, COVID-19 Contracting: Indian Health Service Used Flexibilities to Meet Increased Medical Supply Needs. GAO found that the Indian Health Service (IHS) was able to acquire necessary products (including personal protective equipment and lab supplies) from a variety of vendors during the COVID-19 pandemic. However, GAO found that IHS's contracting officials did not notice some supplies were delivered late. IHS began taking steps to better track products in 2020—including obtaining new software to improve contractor oversight.
• On October 15, 2021, Alston & Bird published a Health Care Advisory entitled, Surprise Billing Regulations Part II – What Does It Mean for Insurers and Providers? The Advisory states that Part II of the Biden Administration’s rules on surprise medical bills adds more requirements for insurers and providers. Alston & Bird’s Health Care Group takes a deep dive into the brave new world created by the regulations under the No Surprises Act.

IV. Other Health Policy News

• On October 8, 2021, HHS launched a Spanish version of its QuestionBuilder app, which can help Latino patients prepare for their in-person or telehealth appointments. The HHS Agency for Healthcare Research and Quality (AHRQ) built QuestionBuilder en Español, which is being released during Hispanic Heritage Month and Health Literacy Month, to improve health care access and equity for Latinos. Latinos have among the highest uninsured rate of any racial or ethnic group within the United States. HHS also released a report that shows insurance coverage and access to care improved significantly for Latinos between 2013 and 2016 after passage of the Affordable Care Act. Despite these improvements, however, Latinos are still more likely to delay care and are less likely to have a usual source of care – disparities that are even larger among Spanish speaking individuals. More information on these actions can be found here.
• On October 8, 2021, HHS released a fact sheet highlighting several initiatives to promote behavioral health for children and youth. More information on the fact sheet can be found here.
• On October 14, 2021, HHS announced the availability of $100 million in American Rescue Plan (ARP) funding for state-run programs that support, recruit, and retain primary care clinicians who live and work in underserved communities. This funding represents a five-fold increase to the Health Resources and Services Administration’s (HRSA) State Loan Repayment Program (SLRP), and helps improve health equity by ensuring that clinicians working in high-need communities remain in them. More information on this funding can be found here.
• On October 15, 2021, the HHS Office of the Assistant Secretary for Preparedness and Response (ASPR) issued a Renewal of Determination that a public health emergency exists. As a result of the continued consequences of the Coronavirus Disease 2019 (COVID-19) pandemic, HHS Secretary Xavier Becerra renewed, effective October 18, 2021, the determination that a public health emergency exists and has existed since January 27, 2020, nationwide. More information about this renewal can be found here.

Click here to view the members of our Health Care Legislative & Public Policy team.