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:
Congress approved an $8.3 billion supplemental funding package to respond to the COVD-19 outbreak. Read more about this week’s congressional and regulatory activity below.
I. Regulations, Notices, & Guidance
- On March 2, 2020, the Food and Drug Administration (FDA) issued a notice entitled, Product-Specific Guidances; Draft and Revised Draft Guidances for Industry. The guidances provide product-specific recommendations on, among other things, the design of bioequivalence studies to support abbreviated new drug applications.
- On March 4, 2020, the FDA issued a notice entitled, Purple Book Enhancement; Establishment of a Public Docket; Request for Comments. This announces the completion of the first phase of the enhanced Purple Book on February 24, 2020. The FDA is transitioning the current table format to a searchable, public-facing online database.
- On March 4, 2020, the FDA issued a guidance entitled, The “Deemed to Be a License” Provision of the Biologics Price Competition and Innovation Act: Questions and Answers; Guidance for Industry; Availability. The guidance is intended to provide answers to common questions about FDA’s implementation of the statutory provision under which an application for a biological product approved under the Federal Food, Drug, and Cosmetic Act (FD&C Act) as of March 23, 2020, will be deemed to be a license for the biological product under the Public Health Service Act on March 23, 2020. This guidance also describes FDA’s compliance policy for the labeling of biological products that will be the subject of deemed biologics license applications. This guidance is intended to facilitate planning for the March 23, 2020, transition date and provide further clarity regarding the FDA’s implementation of the statutory provision. This guidance finalizes the draft guidance of the same title issued on December 12, 2018.
- On March 5, 2020, the FDA issued a notice entitled, Policy for Diagnostics Testing in Laboratories Certified to Perform High Complexity Testing Under the Clinical Laboratory Improvement Amendments Prior to Emergency Use Authorization for Coronavirus Disease-2019 During the Public Health Emergency; Immediately in Effect Guidance for Clinical Laboratories and Food and Drug Administration Staff; Availability. On February 4, 2020, the Secretary of Health and Human Services (HHS) determined that there is a public health emergency and that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of the novel coronavirus (2019-nCoV). Rapid detection of Coronavirus Disease-2019 (COVID-19) cases in the United States requires wide availability of diagnostic testing to control the emergence of this rapidly spreading, severe illness. This guidance describes a policy regarding laboratories using tests they develop and validate before FDA has issued an Emergency Use Authorization (EUA) for their test in order to achieve more rapid testing capacity in the United States. The guidance document is immediately in effect, but it remains subject to comment in accordance with the Agency's good guidance practices.
Event Notices
- March 9, 2020: FDA and the Federal Trade Commission (FTC) announced a public workshop entitled, Workshop on a Competitive Marketplace for Biosimilars. The purpose of the public workshop is to discuss FDA and FTC's collaborative efforts to support appropriate adoption of biosimilars, discourage false or misleading communications about biosimilars, and deter anticompetitive behaviors in the biologic product marketplace.
- March 10, 2020: FDA announced a public meeting entitled, Patient-Focused Drug Development for Stimulant Use Disorder. The purpose of the meeting is to allow FDA to obtain stakeholder perspectives on the impact of stimulant use disorder and views on treatment approaches for stimulant use disorder.
- 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.
II. Congressional Hearings
U.S. Senate
- On March 3, 2020, the Senate Committee on Health, Education, Labor and Pensions held a hearing entitled, An Emerging Disease Threat: How the U.S. is Responding to COVID-19, the Novel Coronavirus.
House of Representatives
- On March 3, 2020, the House Energy & Commerce Committee Subcommittee on Health held a hearing entitled, Combatting an Epidemic: Legislation to Help Patients with Substance Use Disorders.
- On March 3, 2020, the House Appropriation Subcommittee on Labor, Health and Human Services, Education, and Related Agencies held a hearing entitled, Reducing Child Poverty.
- On March 4, 2020, the House Appropriations Subcommittee on Labor, Health and Human Services, Education, and Related Agencies held a hearing on the National Institutes of Health Budget Request.
III. Reports, Studies, & Analyses
- On March 4, 2020, the Congressional Budget Office (CBO) issued a cost estimate on H.R. 6074, the Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020. The bill would authorize $7.7 billion in discretionary funding to respond to the outbreak and $490 million for changes to telemedicine payment requirements under Medicare to treat seniors remotely.
IV. Other Health Policy News
- On March 5-6, 2020, the Medicare Payment and Access Commission held their March meeting. The meeting agenda is accessible here.
- On March 5, 2020, the Centers for Medicare & Medicaid Services (CMS) developed a Healthcare Common Procedure Coding System (HCPCS) code that laboratories can use to bill for COVID-19 diagnostic tests. Last month, CMS developed a code that was specific to Centers for Disease Control and Prevention (CDC) labs to test for SARSCoV-2. This new code allows laboratories to bill for non-CDC laboratory tests for SARS-CoV-2/2019-nCoV (COVID-19). Additional information regarding the new code is available here.
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