Alston & Bird Health Care Week in Review, July 2, 2020

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 Monday, the U.S. House of Representatives passed legislation to expand the ACA’s insurance subsidies and encourage more states to extend Medicaid eligibility. Read more about this bill and other news below.

I. Regulations, Notices, & Guidance

• On June 29, 2020, the Food and Drug Administration (FDA) issued guidance entitled, Review and Update of Device Establishment Inspection Processes and Standards. FDA is issuing this draft guidance to comply with section 702(b)(1) of the FDA Reauthorization Act of 2017 (FDARA) (Public Law 115-52), which directs FDA to issue draft guidance that specifies how the Agency will implement uniform processes and standards that are applicable to inspections ( other than for-cause) of foreign and domestic medical device establishments. FDA updated processes and standards as needed, to address the new provisions in section 704(h)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) that were added by FDARA section 702(a), and to establish a standard timeframe for inspections. This draft guidance also describes standardized methods of communication during the inspection process, and identifies practices for investigators and device establishments to facilitate the continuity of inspections of such establishments.
• On June 29, 2020, the FDA issued guidance entitled, Development of Anti-Infective Drug Products for the Pediatric Population. The purpose of this guidance is to provide general recommendations on the development of anti-infective drug products for the pediatric population. FDA encourages sponsors to discuss their initial pediatric study plans (iPSPs) for anti-infective drug products with the Agency early and, in most instances, no later than 60-calendar days after the end-of-phase 2 meeting.
• On June 30, 2020, FDA issued guidance entitled, Development and Licensure of Vaccines to Prevent COVID-19. FDA plays a critical role in protecting the United States from threats such as emerging infectious diseases, including the COVID-19 pandemic which has been caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).  FDA is committed to providing timely guidance to support response efforts to this pandemic. FDA is issuing this guidance to assist sponsors in the clinical development and licensure of vaccines for the prevention of COVID-19.
• On July 1, 2020, FDA issued guidance entitled, Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices and Certain Devices Requiring Direct Marking. FDA's unique device identification system is designed to adequately identify devices through distribution and use. Its requirements were designed to be phased in over seven years according to established compliance dates based primarily on device classification. This guidance describes FDA's intention with regard to enforcement of these requirements for class I and unclassified devices. This guidance also describes FDA's direct mark compliance policy for class III, LS/LS, and class II devices that are non-sterile, that are manufactured and labeled prior to their applicable direct mark compliance date, and that remain in inventory, as well as for class I and unclassified devices that are not LS/LS devices, that are non-sterile, that are manufactured and labeled prior to September 24, 2022, and that remain in inventory.

Event Notices

• July 14, 2020: FDA announced a public meeting entitled, Meeting of the Oncologic Drugs Advisory Committee. The committee will discuss biologic license application (BLA) 761158, for belantamab mafodotin, submitted by GlaxoSmithKline Intellectual Property Development Ltd. England. The proposed indication for this product is for the treatment of adults with relapsed or refractory multiple myeloma who have received at least four prior therapies including an anti-CD38 monoclonal antibody, a proteasome inhibitor, and an immunomodulatory agent.
• July 16, 2020: The Centers for Disease Control and Prevention (CDC) announced a public meeting entitled, Meeting for the Board of Scientific Counselors, Center for Preparedness and Response. The agenda will include discussions on Center for Preparedness and Response Director Updates and Board of Scientific Counselors members’ perspectives on COVID-19 pandemic preparedness and response.
• July 21, 2020: FDA announced a public meeting entitled, Generic Drug User Fee Amendments (GDUFA) of 2017. At the end of September 2022, new legislation will be required for FDA to continue to collect generic drug user fees for future fiscal years. The purpose of this meeting is for the public to present its views on the reauthorization, including specific suggestions for changes to the goals referred to in the GDUFA Reauthorization Performance Goals and Program Enhancements Fiscal Years 2018-2022 (i.e., the GDUFA II Commitment Letter).
• July 22, 2020: The Centers for Medicare & Medicaid Services (CMS) announced a public meeting entitled, Meeting of the Medicare Evidence Development and Coverage Advisory Committee. This meeting will focus on the home use of noninvasive positive pressure ventilation in patients with chronic respiratory failure (CRF) consequent to chronic obstructive pulmonary disease (COPD). CMS is seeking the MEDCAC’s recommendations regarding the characteristics that define those patient selection and usage criteria, concomitant services, and equipment parameters necessary to best achieve positive patient health outcomes in beneficiaries with CRF consequent to COPD.
• July 23, 2020: FDA announced a public meeting entitled, Reauthorization of the Prescription Drug User Fee Act. The purpose of the meeting is to discuss proposed recommendations for the reauthorization of the Prescription Drug User Fee Act (PDUFA) for fiscal years 2023 through 2027.
• July 25, 2020: CMS announced a public meeting entitled, Meeting of the Advisory Panel on Outreach and Education (APOE). The purpose of the meeting is to discuss opportunities to enhance the effectiveness of consumer education strategies concerning the Health Insurance Marketplace, Medicare, Medicaid, and the Children's Health Insurance Program (CHIP).
• July 30, 2020: The Health Resources and Services Administration announced a public meeting entitled, Meeting of the National Advisory Committee on Rural Health and Human Services. At this meeting, the National Advisory Committee on Rural Health and Human Services (NACRHHS) will discuss the development of a vision statement that emphasizes rural community transformation, sustainable services, and resiliency

II. Congressional Hearings

U.S. House of Representatives

• On June 30, 2020, the House Committee on Energy and Commerce Subcommittee on Health held a hearing entitled, High Anxiety and Stress: Legislation to Improve Mental Health During Crisis. Witnesses present included: Former Representative Patrick J. Kennedy, Founder, The Kennedy Forum; Dr. Arthur C. Evans, Jr., CEO, American Psychological Association; Dr. Jeffrey L. Geller, President, American Psychiatric Association, Professor of Psychiatry and Director of Public Sector Psychiatry at the University of Massachusetts Medical School Worcester Recovery Center and Hospital; and Arriana Gross, National Youth Advisory Board Member, Sandy Hook Promise Students Against Violence Everywhere (SAVE) Promise Club.
• On July 2, 2020, the House Select Subcommittee on the Coronavirus Crisis held a hearing entitled, , The Administration’s Efforts to Procure, Stockpile, and Distribute Critical Supplies. Witnesses present included: The Honorable Kevin Fahey, Assistant Secretary of Defense for Acquisition, Department of Defense; Admiral Brett Giroir, MD, Assistant Secretary for Health, United States Department of Health and Human Services (HHS); and Rear Admiral John Polowczyk, Vice Director of Logistics, Joint Chiefs of Staff, Supply Chain Stabilization Task Force, Department of Defense.
• On July 2, 2020, the House Committee on Small Business Subcommittee on Economic Growth, Tax, and Capital Access held a hearing entitled, Supply Chain Resiliency. Witnesses present included: Dr. Eswar Prasad, Professor of Trade Policy, Cornell University & Senior Fellow, Brookings Institution; Ms. Christine Fagnani, Co-Owner and Vice President, Lynn Medical Instrumentation Company; Mr. David Billstrom, CEO, Kitsbow Cycling Apparel; and Ms. Sheila Lawson, Chief Operations Officer and Vice President of Supply Chain, RL Hudson.

U.S. Senate

• On June 30, 2020, the Senate Health, Education, Labor, and Pensions (HELP) Committee held a hearing entitled, COVID-19: Update on Progress Toward Safely Getting Back to Work and Back to School. Witnesses present included: Witnesses present included: Anthony Fauci, Director, National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH); Dr. Robert Redfield, Director, United States Centers for Disease Control and Prevention (CDC); Admiral Brett Giroir, MD, Assistant Secretary for Health, HHS; and Dr. Stephen Hahn, FDA Commissioner.
• On June 30, 2020, the Senate Foreign Relations Committee held a hearing entitled, COVID-19 and the U.S. International Pandemic Preparedness, Prevention, and Response: Additional Perspectives. Witnesses present included: Dr. Mark Dybul, Co-Director of the Center for Global Health Practice and Impact and Professor in the Department of Medicine, Georgetown University Medical Center; Dr. Ashish K. Jha, Director, Harvard Global Health Institute; Jimmy J. Kolker, Former Assistant Secretary for Global Affairs, HHS; and Mr. Jeremy Konyndyk, Senior Policy Fellow, Center for Global Development.
• On July 1, 2020, the Senate Indian Affairs Committee held a hearing entitled, Evaluating the Response and Mitigation to the COVID-19 Pandemic in Native Communities. Witnesses present included: RADM Michael Weahkee, Director, Indian Health Service, HHS; Mr. Robert Fenton Jr., Regional Administrator, Region 9, Federal Emergency Management Agency, U.S. Department of Homeland Security; Mr. Scott Davis, Executive Director, North Dakota Indian Affairs Commission, Office of the Governor, State of North Dakota; and Ms. Lisa Elgin, Secretary, National Indian Health Board.
• On July 3, 2020, the Senate Committee on Appropriations Subcommittee on Labor, Health and Human Services, Education, and Related Agencies held a hearing entitled, Review of Operation Warp Speed: Researching, Manufacturing, and Distributing a Safe and Effective Coronavirus Vaccine. Witnesses present included: Dr. Francis Collins, Director, NIH; Dr. Robert Redfield, Director, CDC; and Dr. Gary Disbrow, Acting Director, Biomedical Advanced Research and Development Authority Acting Deputy Assistant Secretary for Preparedness and Response, HHS.

III. Reports, Studies, & Analyses

• On June 30, 2020, RAND Corporation published a report entitled, Health Services and Primary Care Research Study. This report presents the results of a congressionally mandated, independent assessment of federally funded health services research (HSR) and primary care research (PCR) spanning the HHS and U.S. Department of Veterans Affairs (VA) from fiscal years 2012 to 2018. Through technical expert panels, stakeholder interviews, and a systematic environmental scan of research grants and contracts funded by HHS and the VA, the authors characterize the distinct contributions of agencies in these departments to the federal HSR and PCR enterprise. The authors also identify opportunities to improve detection and coordination of overlap in agency research portfolios, the impacts of HSR and PCR and how they cumulate across research portfolios, and gaps in research funding, methods, and dissemination. The authors offer recommendations to maximize the outcomes and value of future investments in federal HSR and PCR to better guide and serve the needs of a complex and rapidly changing U.S. health care system.
• On July 1, 2020, Republicans on the House Committee on Energy and Commerce released a report examining federal efforts to accelerate the development of vaccines and therapeutics to fight COVID-19. Among other recommendations, members are urging the federal government to protect the supply of seasonal influenza vaccines by encouraging more domestic production. They are also recommending the White House create a comprehensive, national vaccine plan, which members of both parties have been calling on the Trump Administration to roll out.

IV. Other Health Policy News

• On June 29, 2020, the U.S. House of Representatives passed R. 1425, The Patient Protection and Affordable Care Enhancement Act, a legislative package that would expand the Affordable Care Act’s (ACA) insurance subsidies and encourage more states to extend eligibility for their public health insurance programs for the poor by reducing federal funds to those states for certain administrative services. The bill also includes measures from the House-passed drug pricing package (H.R. 3), which would direct Medicare to negotiate prices for certain medications. However, the package is largely a messaging piece and has been declared dead on arrival in the Senate.
• On June 29, 2020, HHS announced an agreement to secure large supplies of the drug remdesivir for the United States from Gilead Sciences through September, allowing American hospitals to purchase the drug in amounts allocated by HHS and state health departments. More information about this agreement can be found here.
• On June 30, 2020, HHS announced that it will extend its partnership with national pharmacy and grocery retail chains CVS, Rite-Aid, Walgreens, Quest (through services at Walmart) and eTrueNorth (through services at Kroger, Health Mart, and Walmart) so they may continue to seamlessly provide Americans convenient access to COVID-19 testing. The partnership, which is part of the Community-Based Testing Program, has scaled up to more than 600 COVID-19 testing sites in 48 states and the District of Columbia. Approximately 70 percent of these testing sites are located in communities with moderate-to-high social vulnerability, as evidenced by their racial, and ethnic composition, and their housing, economic, language barrier, and similar considerations. More information about this announcement can be found here.
• On June 30, 2020, CMS proposed to update its national coverage policy for a procedure known as transcatheter edge-to-edge repair (TEER) of the mitral valve to include patients with functional mitral regurgitation (MR).  TEER is a less invasive treatment option that involves clipping together a portion of the mitral valve leaflets for patients with a condition where their mitral valves do not close properly. Under the coverage proposal announced today, CMS will expand coverage to patients with functional MR so more patients will have access to this procedure. More information about this proposal can be found here.

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