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:
On March 27, 2020, President Donald Trump signed into law the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) of 2020. Read more about the bill and other news below.
I. Regulations, Notices, & Guidance
- On March 23, 2020, the Food and Drug Administration (FDA) issued guidance entitled, Enforcement Policy for Ventilators and Accessories and Other Respiratory Devices During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency. The FDA plays a critical role in protecting the U.S. from emerging infectious diseases, including the Coronavirus Disease 2019 (COVID-19) pandemic. FDA is committed to providing timely guidance to support response efforts to this pandemic. FDA is issuing this guidance to provide a policy to help expand the availability of ventilators as well as other respiratory devices and their accessories during this pandemic. This policy is intended to remain in effect only for the duration of the public health emergency related to COVID-19 declared by the Department of Health and Human Services (HHS), including any renewals made by the Secretary in accordance with section 319(a)(2) of the PHS Act.
- On March 23, 2020, FDA issued guidance entitled, Policy for Certain REMS Requirements During the COVID-19 Public Health Emergency Guidance for Industry and Health Care Professionals. FDA is issuing this guidance to communicate its temporary policy for certain risk evaluation and mitigation strategies (REMS) requirements for the duration of the public health emergency (PHE) declared by the Secretary of Health and Human Services (HHS) on January 31, 2020.
- On March 25, 2020, FDA issued guidance entitled, Temporary Policy Regarding Preventive Controls and Foreign Supplier Verification Programs Food Supplier Verification Onsite Audit Requirements During the COVID-19 Public Health Emergency. This guidance communicates FDA’s intention not to enforce certain onsite audit requirements in three of our food safety regulations in certain circumstances related to the impact of the coronavirus if other supplier verification methods that are designed to provide sufficient assurance that hazards have been significantly minimized or prevented are used instead during the period of onsite audit delay.
- On March 27, 2020, the Drug Enforcement Administration issued a final rule entitled, Schedules of Controlled Substances: Placement of FUB-AMB in Schedule I. The DEA places methyl 2-(1-(4- fluorobenzyl)-1H-indazole-3-carboxamido)-3-methylbutanoate (other names: FUBAMB, MMB-FUBINACA, AMB-FUBINACA), including its salts, isomers, and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible, in schedule I of the Controlled Substances Act. This action continues the imposition of the regulatory controls and administrative, civil, and criminal sanctions applicable to schedule I controlled substances on persons who handle (manufacture, distribute, import, export, engage in research, conduct instructional activities or chemical analysis, or possess), or propose to handle FUB-AMB.
- On March 27, 2020, FDA issued guidance entitled, Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing Under Section 506C of the FD&C Act. Due to the COVID-19 pandemic, FDA has been closely monitoring the medical product supply chain with the expectation that it may be impacted by the COVID-19 outbreak, potentially leading to supply disruptions or shortages of drug and biological products in the U.S. FDA is issuing this guidance to assist applicants and manufacturers in providing FDA timely, informative notifications about changes in the production of certain drugs and biological products that will, in turn, help the Agency in its efforts to prevent or mitigate shortages of such products.
- On March 27, 2020, FDA issued guidance entitled, Center for Devices and Radiological Health (CDRH) Appeals Processes: Questions and Answers About 517A. This guidance document provides the Center for Devices and Radiological Health (CDRH or the Center) interpretation of key provisions set forth in section 517A of the Federal Food, Drug, and Cosmetic Act (FD&C Act), as those provisions pertain to requests for appeals of significant decisions under 21 CFR 10.75, as well as for the timeframes and procedures of regulatory decisions and actions taken by CDRH under 21 CFR 800.75.
Event Notices
- April 15, 2020:The National Institutes of Health (NIH) announced a Committee meeting of the National Institute of Allergy and Infectious Diseases Special Emphasis Panel NIAID Resource-Related Research Projects.
- April 16, 2020:The FDA announced a public meeting entitled, Scientific and Ethical Considerations for the Inclusions of Pregnant Women in Clinical Trials. The meeting is intended to gather industry, patient, clinician, researcher, institutional review board, ethicist, professional society and other stakeholder input on the scientific and ethical issues that surround the inclusion of pregnant women in clinical trials for drug development.
II. Congressional Hearings
There were no health-related hearings this week.
III. Reports, Studies, & Analyses
- On March 26, 2020, the Kaiser Family Foundation (KFF) published a report entitled, Medicaid and CHIP Eligibility, Enrollment, and Cost Sharing Policies as of January 2020: Findings from a 50-State Survey. This 18th annual survey of the 50 states and the District of Columbia (DC) provides data on Medicaid and the Children’s Health Insurance Program (CHIP) eligibility, enrollment, renewal, and cost sharing policies as of January 2020. The survey findings highlight state variation in policies that affect individuals’ ability to access coverage and care amid the COVID-19 public health crisis. They also provide examples of actions states can take to expand eligibility and simplify enrollment to respond to the COVID-19 epidemic. Further, the survey findings highlight how changes under the ACA to expand Medicaid eligibility and streamline enrollment and renewal processes have better positioned the Medicaid program to respond to a public health crisis such as COVID-19
- On March 27, 2020, KFF published an issue brief entitled, How Prepared is the U.S. to Respond to COVID-19 Relative to Other Countries? The collection of charts and analyses highlight available cross-national data on the healthcare workforce, hospital resources, and at-risk populations in select countries. Additional charts explore coverage and affordability barriers that may limit access to care or cause serious financial burden for those needing COVID-19 treatment. Where data are available, the authors compare the U.S. to countries that are similarly large and wealthy (Australia, Austria, Belgium, Canada, France, Germany, Japan, the Netherlands, Sweden, Switzerland, the United Kingdom) as well as other countries that have a large number of patients with COVID-19 (China, Italy, Iran, South Korea, and Spain).
- On March 26, 2020, the Government Accountability Office (GAO) published a report entitled, Drug Misuse: Sustained National Efforts Are Necessary for Prevention, Response, and Recovery. Drug misuse has been a persistent and long-standing public health issue in the U.S. Ongoing drug control efforts seek to address drug misuse through education and prevention, addiction treatment, and law enforcement and drug interdiction, as well as programs that serve populations affected by drug misuse. These efforts involve federal, state, local, and tribal governments as well as community groups and the private sector. In recent years, the federal government has spent billions of dollars and has enlisted more than a dozen agencies to address drug misuse and its effects. This report provides information on (1) trends in drug misuse; (2) costs and other effects of drug misuse on society and the economy; and (3) challenges the nation faces in addressing the drug crisis. GAO analyzed nationally representative federal data on drug misuse and deaths from overdoses for 2002–2018 (the most recent available); reviewed selected empirical studies published from 2014–2019; and compared GAO's High-Risk list criteria to findings and recommendations in over 75 GAO reports issued from fiscal year 2015 through March 2020.
IV. Other Health Policy News
- On March 23, 2020, President Trump issued an executive order intended to prevent the hoarding of health and medical resources to respond to the spread of COVID-19. On March 25, HHS Secretary Alex Azar announced a list of certain health and medical resources that are subject to hoarding prevention measures. The list can be found here.
- On March 24, 2020, HHS Office of the Assistant Secretary for Preparedness and Response (HHS ASPR) announced it will provide $100 million to aid U.S. healthcare systems in preparing quickly for a surge in COVID-19 patients. The support will directly benefit the National Special Pathogen System and is authorized in the Coronavirus Preparedness and Response Supplemental Appropriations Act of 2020. More information about this funding can be found here.
- On March 27, 2020, President Donald Trump signed into law the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) of 2020. The $2 trillion coronavirus relief package, which passed the U.S. Senate on March 25 and the U.S. House of Representatives on March 27, is intended to provide immediate assistance to many Americans, small businesses, and major industries on the brink of economic collapse amid the ongoing pandemic. The legislation is the largest emergency aid package in U.S. history and key elements of the package include sending checks directly to individuals and families, a major expansion of unemployment benefits, money for hard-hit hospitals and health care providers, financial assistance for small businesses and $500 billion in loans for distressed companies. More information about the provisions of the package can be found here.
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