Alston & Bird Health Care Week in Review, June 5, 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 Thursday, HHS issued new laboratory data reporting guidance for COVID-19 testing. Read more about this guidance and other news below.

I. Regulations, Notices, & Guidance

• On June 2, 2020, the Food and Drug Administration (FDA) issued guidance entitled, Institutional Review Board (IRB) Review of Individual Patient Expanded Access Requests for Investigational Drugs and Biological Products During the COVID-19 Public Health Emergency Guidance for IRBs and Clinical Investigators. During the COVID-19 public health emergency, the FDA has received a substantially increased volume of individual patient expanded access requests for COVID-19 investigational drugs. Although FDA has issued guidance on expanded access requests, including expanded access for individual patients, the FDA is aware that Institutional Review Boards (IRBs) seek clarity regarding the key factors and procedures IRBs should consider when reviewing individual patient expanded access submissions, including for reviews conducted by a single member of the IRB, to fulfill its obligations under 21 CFR Part 56. Therefore, FDA is issuing this guidance to provide recommendations regarding the key factors and procedures IRBs should consider when reviewing expanded access submissions for individual patient access to investigational drugs for treating COVID-19.
• On June 3, 2020, FDA issued guidance entitled, Product-Specific Guidances. The guidances provide product-specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs).
• On June 5, 2020, FDA issued revised guidance entitled, Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency. FDA is issuing this guidance to provide a policy to help expand the availability and capability of non-invasive remote monitoring devices to facilitate patient monitoring while reducing patient and healthcare provider contact and exposure to COVID-19 for the duration of the COVID-19 public health emergency. This policy is intended to remain in effect only for the duration of the public health emergency related to COVID-19 declared by the Secretary of the Department of Health and Human Services (HHS) on January 31, 2020, effective January 27, 2020, including any renewals made by the HHS Secretary in accordance with section 319(a)(2) of the Public Health Service Act (PHS Act) (42 U.S.C. 247d(a)(2)).
• On June 5, 2020, the Drug Enforcement Administration (DEA) issued a final rule entitled, Listing of Ethylone in Schedule I of Controlled Substances and Assignment of an Administration Controlled Substances Code Number. This is a final rule establishes a specific listing and administration controlled substances code number for ethylone (also known as 1-(1,3-benzodioxol-5-yl)-2-(ethylamino)propan-1-one; 3,4- methylenedioxy-N-ethylcathinone; bk-MDEA; MDEC) in schedule I of the Controlled Substances Act (CSA).

Event Notices

• June 8, 2020: The National Institutes of Health (NIH) announced a public meeting entitled, Meeting of the Muscular Dystrophy Coordinating Committee. The purpose of this meeting is to bring together committee members, representing government agencies, patient advocacy groups, other voluntary health organizations, and patients and their families to update one another on progress relevant to the Action Plan for the Muscular Dystrophies and to coordinate activities and discuss gaps and opportunities leading to better understanding of the muscular dystrophies, advances in treatments, and improvements in patients' and their families' lives.
• June 9, 2020: HHS announced a public meeting entitled, Meeting of the National Vaccine Advisory Committee. The meeting will focus on coronavirus vaccine development, reimbursement, and changes in billing and coverage with updates from members.
• June 17-18: FDA announced a public meeting entitled, Meeting of the Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committe Information will be presented regarding pediatric development plans for four products that are in development for an adult oncology indication. The subcommittee will consider and discuss issues relating to the development of each product for pediatric use and provide guidance to facilitate the formulation of written requests for pediatric studies, if appropriate.
• June 22, 2020: The Centers for Medicare & Medicaid Services (CMS) announced a public meeting entitled, Public Meeting Regarding New and Reconsidered Clinical Diagnostic Laboratory Test Codes for the Clinical Laboratory Fee Schedule for Calendar Year 2021. The purpose of this meeting is to receive comments and recommendations (including data on which recommendations are based) on the appropriate basis for establishing payment amounts for new or substantially revised Healthcare Common Procedure Coding System codes being considered for Medicare payment under the Clinical Laboratory Fee Schedule (CLFS) for calendar year 2021.
• June 24, 2020: The Centers for Disease Control and Prevention (CDC) announced a public meeting entitled, Meeting of the Advisory Committee on Immunization Practices. The meeting agenda will include discussions on SARS-CoV-2(COVID-19) Vaccines, influenza vaccines, and meningococcal vaccines. A recommendation vote is scheduled for influenza vaccines and a VFC vote is schedule for meningococcal vaccines.
• June 26, 2020: HHS announced a public meeting entitled, Meeting of the National Clinical Care Commission. The Commission will evaluate and make recommendations to the HHS Secretary and Congress regarding improvements to the coordination and leveraging of federal programs related to diabetes and its complications.
• June 29-30, 2020: CMS announced a public meeting entitled, Meeting Announcement for the Medicare Advisory Panel on Clinical Diagnostic Laboratory Tests. The Panel will provide input and recommendations on the establishment of payment rates under section 1834A of the Act for new clinical diagnostic laboratory tests, including whether to use “crosswalking” or “gapfilling” processes to determine payment for a specific new test; the factors used in determining coverage and payment processes for new clinical diagnostic laboratory tests; and other aspects of the new payment system under section 1834A of the Act.
• June 30, 2020: FDA announced a public meeting entitled, Modernizing the Food and Drug Administration's Data Strategy. The purpose of the meeting is to provide an opportunity to hear from FDA staff and outside experts on topics directly related to modernizing FDA's data strategy, including data quality, data stewardship, data exchange, and data analytics.
• July 16, 2020: 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 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.

II. Congressional Hearings

U.S. House of Representatives

• On June 2, 2020, the House Committee on Energy and Commerce Subcommittee on Oversight and Investigations held a hearing entitled, On the Front Lines: How Governors are Battling the COVID-19 Pandemic. Witnesses present included: Governor Jared Polis (CO); Governor Gretchen Whitmer (MI); and Governor Asa Hutchinson (AR).
• On June 4, 2020, the House Appropriations Committee held a hearing on Thursday entitled, COVID-19 Response. Witnesses present included Dr. Robert Redfield, Director, CDC.

U.S. Senate

• On June 2, 2020, the Senate the Senate Judiciary Committee held a hearing entitled, Examining Best Practices for Incarceration and Detention During COVID-19. Witnesses present included: Mr. Michael Carvajal, Director, Federal Bureau of Prisons; Dr. Jeffry Allen, Medical Director, Federal Bureau of Prisons; Mr. Henry Lucero, Executive Associate Director, Enforcement and Removal Operation, U.S. Immigration and Customs Enforcement (ICE), Department of Homeland Security (DHS); Dr. Ada Rivera, Deputy Assistant Director for Clinical Services, ICE, Health Services Corps, DHS; Mr. Bryan Stirling, Director, South Carolina Department of Corrections; and Dr. Scott Allen, Professor Emeritus of Medicine, University of California Riverside.
• On June 2, 2020, the Senate Finance Committee held a hearing entitled, COVID-19 and Beyond: Oversight of the FDA’s Foreign Drug Manufacturing Inspection Process. Witnesses present included: Dr. Judith A McMeekin, Pharm.D, Associate Commissioner for Regulatory Affairs, Office of Regulatory Affairs, Food and Drug Administration (FDA); Dr. Douglas Throckmorton M.D., Deputy Director for Regulatory Programs, Center for Drug Evaluation and Research, FDA; Mark Abdoo, Associate Commissioner for Global Policy and Strategy, FDA; Dr. Mary Denigan-Macauley, Ph.D., Director, Health Care, United States Government Accountability Office (GAO); Martin VanTrieste, President & CEO, CivicaRx; and David Light, Founder and CEO, Valisure.
• On June 4, 2020, the Senate HELP Committee held a hearing entitled, COVID-19: Going Back to College Safely. Witnesses present included: Mitchell Daniels, President, Purdue University; Dr. Christina Paxson, President, Brown University; Dr. Logan Hampton, President, Lane College; and Dr. Georges Benjamin, Executive Director, American Public Health Association.

III. Reports, Studies, & Analyses

• On June 1, 2020, the HHS Office of Inspector General (OIG) published its Spring 2020 Semiannual Report to Congress. The spring Semiannual Report to Congress describes OIG's work identifying significant risks, problems, abuses, deficiencies, remedies, and investigative outcomes relating to the administration of HHS programs and operations that were disclosed during the semiannual reporting period, October 1, 2019, through March 31, 2020.
• On June 1, 2020, the Government Accountability Office (GAO) published a report entitled, Medicaid: State Views on Program Administration Challenges. GAO was asked to assess a range of federal Medicaid policies. This report describes states' perspectives on any challenges related to federal Medicaid policies, including laws, regulations, and procedures; and considerations for any related federal action to address the identified challenges. GAO interviewed Medicaid officials from 50 states and the District of Columbia to obtain information on challenges related to Medicaid program areas, Medicaid waiver processes, and Medicaid reporting requirements. GAO also obtained input from CMS officials on state-identified challenges, reviewed CMS documents and prior GAO work, and reviewed publications from organizations representing Medicaid providers and beneficiaries.
• On June 4, 2020, the Kaiser Family Foundation (KFF) published an issue brief entitled, Insulin Costs and Coverage in Medicare Part D. In light of heightened attention to insulin and the Trump Administration’s new Part D model to address out-of-pocket costs for insulin for Medicare beneficiaries, KFF researchers analyzed out-of-pocket spending on insulin by beneficiaries enrolled in Part D drug plans, variation in Part D plan formulary coverage and tier placement of insulin products, and trends in prices for insulin (not accounting for rebates), based on data from CMS. The authors also discuss the Administration’s Part D demonstration, which will take effect in 2021, and policy proposals introduced in the 116^thCongress that address cost concerns related to insulin.

IV. Other Health Policy News

• On June 1, 2020, CMS unveiled enhanced enforcement for nursing homes with violations of longstanding infection control practices. This announcement builds on the previous actions CMS has taken to ensure the safety and security of America’s nursing homes as the nation battles COVID-19, and is a key step in the Trump Administration’s Guidelines for Opening Up America Again. More information on the enhanced accountability measures can be found here.
• On June 4, 2020, HHS announced new guidance that specifies what additional data must be reported to HHS by laboratories along with COVID-19 test results. The guidance standardizes reporting to ensure that public health officials have access to comprehensive and nearly real-time data to inform decision making in their response to COVID-19. The new reporting requirements will provide information needed to better monitor disease incidence and trends by initiating epidemiologic case investigations, assisting with contact tracing, assessing availability and use of testing resources, and anticipating potential supply chain issues. More information on this guidance can be found here.
• On June 4, 2020, CMS posted the first set of underlying COVID-19 nursing home data. On April 19, 2020, CMS announced the requirement that nursing homes to inform residents, their families, and their representatives of COVID-19 cases in their facilities. In addition to this, nursing homes are required to report COVID-19 cases and deaths directly to the CDC and CMS is making this data publicly available. CMS is also posting the results from the targeted inspections announced on March 4, 2020, to allow inspectors to focus on the most serious health and safety threats like infectious diseases and abuse during the pandemic. More information on this data can be found here.

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