Alston & Bird Health Care Week in Review, June 26, 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:

This week, CMS issued its home health proposed payment rule for 2021, which would boost Medicare reimbursement and make permanent COVID-19 telehealth flexibilities. Read more about the proposal and other news below.

I. Regulations, Notices, & Guidance

• On June 19, 2020, the Food and Drug Administration (FDA) issued guidance entitled, Notifying CDRH of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act During the COVID-19 Public Health Emergency (Revised). FDA is issuing this guidance to implement section 506J of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 351 et seq.), as added by section 3121 of the CARES Act, as it relates to device shortages and potential device shortages occurring during the COVID-19 pandemic, for the duration of the COVID-19 public health emergency. Section 506J of the FD&C Act requires manufacturers to notify FDA of a permanent discontinuance in the manufacture of certain devices or an interruption in the manufacture of certain devices that is likely to lead to a meaningful disruption in supply of that device in the United States. This guidance is intended to assist manufacturers in providing FDA timely, informative notifications about changes in the production of certain medical device products that will help the Agency prevent or mitigate shortages of such devices during the COVID-19 public health emergency. This guidance also recommends that manufacturers voluntarily provide additional details to better ensure FDA has the specific information it needs to help prevent or mitigate shortages during the COVID-19 public health emergency.
• On June 19, 2020, FDA issued guidance entitled, Good Manufacturing Practice Considerations for Responding to COVID-19 Infection in Employees in Drug and Biological Products Manufacturing. FDA is issuing this guidance to provide recommendations to drug and biological product manufacturers regarding manufacturing controls to prevent contamination of drugs; risk assessment of SARS-CoV-2 as it relates to drug safety or quality; and continuity of manufacturing operations.
• On June 22, 2020, FDA issued guidance entitled, Effects of the COVID-19 Public Health Emergency on Formal Meetings and User Fee Applications for Medical Devices. FDA is issuing this guidance to provide answers to frequently asked questions about regulatory and policy issues related to device development for the duration of the COVID-19 public health emergency.
• On June 24, 2020, FDA issued guidance entitled, Community-Acquired Bacterial Pneumonia. The purpose of this guidance is to assist sponsors in the clinical development of antibacterial drugs for the treatment of community-acquired bacterial pneumonia (CABP) based on comments that were received and current recommendations.
• On June 24, 2020, FDA issued guidance entitled, Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia. The purpose of this final guidance is to help sponsors and investigators in the clinical development of antibacterial drugs for the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) based on comments that were received and current recommendations.
• On June 25, 2020, FDA issued guidance entitled, Documents Related to Coronavirus Disease 2019 (COVID-19). The FDA is announcing the availability of FDA guidance documents related to the Coronavirus Disease 2019 (COVID-19) public health emergency (PHE). This notice of availability (NOA) is pursuant to the process that FDA announced, in the Federal Register of March 25, 2020, for making available to the public COVID-19-related guidances. The guidances identified in this notice address issues related to the COVID-19 PHE and have been issued in accordance with the process announced in the March 25, 2020, notice. The guidance documents have been implemented without prior comment, but they remain subject to comment in accordance with the Agency’s good guidance practices.
• On June 25, 2020, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule entitled, CY 2021 Home Health Prospective Payment System Rate Update; Home Health Quality Reporting Requirements; and Home Infusion Therapy Services Requirements. This proposed rule would update the home health prospective payment system (HH PPS) payment rates and wage index for calendar year (CY) 2021. This proposed rule also proposes to make permanent the changes to the home health regulations regarding the use of technology in providing services under the Medicare home health benefit as described in the Medicare and Medicaid Programs; Revisions in Response to the COVID-19 Public Health Emergency interim final rule with comment period. This proposed rule also proposes to remove provisions related to test transmission of OASIS data by a new HHA, because the provision is now obsolete due to changes in CMS’s data submission system. This proposed rule discusses policies finalized in the CY 2020 HH PPS final rule with comment period regarding the permanent home infusion therapy services benefit for CY 2021, and proposes conforming regulations text changes excluding home infusion therapy services from coverage under the Medicare home health benefit. Additionally, this proposed rule discusses Medicare enrollment policies for qualified home infusion therapy suppliers.
• On June 26, 2020, FDA issued guidance entitled, Review and Update of Device Establishment Inspection Processes and Standards. FDA is issuing this guidance to comply with changes to the FD&C Act as amended by the FDA Reauthorization Act of 2017 (FDARA), which requires that FDA review and update, as needed, the processes and standards applicable to inspections (other than for-cause) of domestic and foreign medical device establishments in place as of August 18, 2017. This guidance describes how FDA will implement uniform inspection processes and standards. The 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.

Event Notices

• 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 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: 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 22, 2020, the House Committee on Education and Labor held a hearing entitled, Inequities Exposed: How COVID-19 Widened Racial Inequities in Education, Health, and the Workforce. Witnesses present included: Dr. Camara Jones, Adjunct Professor, Rollins School of Public Health at Emory University, Senior Fellow and Adjunct Associate Professor, Morehouse School of Medicine, Past President, American Public Health Association; Dr. Valerie Rawlston Wilson, Director, Program on Race, Ethnicity, and the Economy, Economic Policy Institute; Mr. Avik Roy, Co-Founder and President, The Foundation for Research on Equal Opportunity; and Mr. John B. King, Jr., President and CEO, The Education Trust.
• On June 23, 2020, the House Committee on Energy & Commerce held a hearing entitled, Oversight of the Trump Administration's Response to the COVID-19 Pandemic. Witnesses present included: Dr. Anthony Fauci, Director, National Institute for Allergy and Infectious Diseases, the National Institutes of Health (NIH); ADM Brett Giroir, M.D., Assistant Secretary for Health, U.S. Department of Health and Human Services (HHS); Dr. Stephen Hahn, Commissioner, FDA; and Dr. Robert Redfield, Director, CDC.
• On June 23, 2020, the House Committee on Ways & Means Subcommittee on Worker & Family Support held a hearing entitled, The Child Care Crisis and the Coronavirus Pandemic. Witnesses present included: Rasheed Malik, Senior Policy Analyst at the Center for American Progress; Regina McChriston, Essential Worker; Dr. Aaliyah Samuel, Executive Vice President of Government Affairs and Partnerships, Northwest Evaluation Association and Non-Resident Fellow at Harvard Center for the Developing Child; and Jennifer Sullivan, Secretary of the Indiana Family and Social Services Administration.
• On June 23, 2020, the House Committee on Budget held a hearing entitled, Health and Wealth Inequality in America: How COVID-19 Makes Clear the Need for Change. Witnesses present included: Sir Angus Deaton, Ph.D., Senior Scholar, Princeton University Woodrow Wilson School, Presidential Professor of Economic, University of Southern California; Dr. Patrice Harris, Immediate Past President of the American Medical Association; Dr. Damon Jones, Associate Professor, University of Chicago Harris School; Mr. Avik Roy, President, Foundation for Research on Equal Opportunity.
• On June 24, 2020, the House Committee on Veterans’ Affairs held a hearing entitled, VA Telehealth During the COVID-19 Pandemic: Expansion and Impact. Witnesses present included: Dr. Jennifer MacDonald, Chief Consultant to the Deputy Undersecretary for Health, Veterans Health Administration (VHA); Mr. Jack Galvin, Acting Deputy Assistant Secretary for IT Development Security Operations, Office of Information Technology (OIT); Dr. Neil Evans, Chief Officer, Office of Connected Care, VHA; Dr. Kevin Galpin, Executive Director, Telehealth Services, Office of Connected Care, VHA; Ms. Tammy Barlet, Associate Director, National Legislative Services, Veterans of Foreign Wars; Mr. Marquis Barefield, Assistant National Legislative Director, Disabled Veterans of America; Ms. Lindsay Church, Co-Founder/Executive Director, Minority Veterans of America; and Chief William Smith, Vice Chairperson, National Indian Health Board, Valdez Tribe of Alaska.
• On June 25, 2020, the House Committee on Ways & Means Subcommittee on Health held a hearing entitled, Examining the COVID-19 Nursing Home Crisis. Witnesses present included: Delia Satterwhite, Family Member; Melinda Haschak, Licensed Practical Nurse, Regalcare at Southport; Nicole Howell, Executive Director, Ombudsman Services of Contra Costa Inc.; Toby S. Edelman, JD; Senior Policy Attorney, Center for Medicare Advocacy; Dr. David Grabowski, Professor, Harvard Medical School; Dana Kennedy, Arizona State Director, AARP; and Rebecca Gould, President/CEO, Schuyler Hospital.
• On June 26, 2020, the House Select Subcommittee on the Coronavirus Crisis held a hearing entitled, Accountability in Crisis: GAO's Recommendations to Improve the Federal Coronavirus Response. Witnesses present included: The Honorable Gene L. Dodaro, Comptroller General of the U.S. Government Accountability Office (GAO).

U.S. Senate

• On June 23, 2020, the Senate Health, Education, Labor, and Pensions (HELP) Committee held a hearing entitled, COVID-19: Lessons Learned to Prepare for the Next Pandemic. Witnesses present included: Dr. William Frist, Former U.S. Senate Majority Leader; Dr. Joneigh Khaldun, Chief Medical Executive and Chief Deputy Director for Health, Michigan Department of Health and Human Services; Dr. Julie Gerberding, Executive Vice President and Chief Patient Officer, Merck & Co., Inc., Co-Chair, CSIS Commission on Strengthening America’s Health Security; and Governor Michael O. Leavitt, Former HHS Secretary.
• On June 24, 2020, the Senate Committee on Homeland Security & Governmental Affairs held a hearing entitled, The Role of the Strategic National Stockpile in Pandemic Response. Witnesses present included: Dr. Julie L. Gerberding, Former Director of the CDC (2002-2009); Daniel M. Gerstein, Ph.D., Senior Policy Researcher, RAND Corporation; W. Gregory Burel, Former Director of the Strategic National Stockpile (2007-2020); and Andrew Phelps, Director, Oregon Office of Emergency Management.

III. Reports, Studies, & Analyses

• On June 22, 2020, the Kaiser Family Foundation (KFF) published an issue brief entitled, State Efforts to Expand Medicaid Coverage & Access to Telehealth in Response to COVID-19. To increase health care accessibility and limit risk of exposure during the COVID-19 pandemic, all fifty states and DC are expanding telehealth access for Medicaid beneficiaries. This issue brief highlights recently released federal guidance to assist Medicaid programs in developing telehealth policies in response to the COVID-19, discusses trends in state Medicaid activity to expand coverage and access to telehealth, and highlights state and federal activity support provider infrastructure and patient access to telehealth.
• On June 25, 2020, KFF published an issue brief entitled, How Many Uninsured Adults Could Be Reached If All States Expanded Medicaid? As more people lose their jobs and accompanying employer sponsored insurance, more may fall into the coverage gap, particularly starting in 2021 after unemployment benefits expire for many who have lost their jobs and incomes are likely to drop below the minimum threshold for marketplace subsidies. This analysis estimates how many uninsured adults—including those uninsured even before the pandemic and those who could become uninsured as a result of it—could become eligible for Medicaid if states that have not yet expanded the program do so.
• On June 25, 2020, GAO published a report entitled, COVID-19: Opportunities to Improve Federal Response and Recovery Efforts. The CARES Act includes a provision for GAO to report bimonthly on its ongoing monitoring and oversight efforts related to the COVID-19 pandemic. This initial report examines key actions the federal government has taken to address the COVID-19 pandemic and evolving lessons learned relevant to the nation’s response to pandemics, among other things. GAO reviewed data and documents from federal agencies about their activities and interviewed federal and state officials as well as industry representatives. GAO also reviewed available economic, health, and budgetary data.

IV. Other Health Policy News

• On June 23, 2020, a federal judge ruled the Trump Administration can proceed with its mandate that hospitals publish negotiated rates, rejecting the American Hospital Association’s call for the court to scrap CMS’ hospital price transparency rule that is expected to go into effect in January 2021. The 2019 final rule requires that hospitals make their standard charges public for all items and services, meaning a hospital’s gross charges and payer-specific negotiated charges must be revealed. These public standard charges are required to be machine-readable and include common billing or accounting codes and a description of the item or service, CMS says. The rule requires hospitals reveal the prices of at least 300 services, with some chosen by CMS, in a consumer-friendly manner. The American Hospital Association said it will appeal the case and seek expedited review.
• On June 23, 2020, CMS announced the creation of the Office of Burden Reduction and Health Informatics to unify the agency’s efforts to reduce regulatory and administrative burden and to further the goal of putting patients first. The new office is an outgrowth of the agency’s Patients over Paperwork Initiative, which is the cornerstone of CMS’s ongoing efforts to implement President Trump’s 2017 executive order to “Cut the Red Tape” and eliminate duplicative, unnecessary, and excessively costly requirements and regulations. More information about this organizational change can be found here.
• On June 23, 2020, the HHS Office of Minority Health (OMH) announced the selection of the Morehouse School of Medicine as the awardee for a new $40 million initiative to fight COVID-19 in racial and ethnic minority, rural and socially vulnerable communities. The Morehouse School of Medicine will enter into a cooperative agreement with OMH to lead the initiative to coordinate a strategic network of national, state, territorial, tribal and local organizations to deliver COVID-19-related information to communities hardest hit by the pandemic. More information on this partnership can be found here.
• On June 25, 2020, CMS released a trends report that provides data on the number of individuals who signed up for coverage on HealthCare.gov through a special enrollment period (SEP) during the COVID-19 pandemic. More information about the report can be found here.
• On June 25, 2020, HHS published an updated solid organ transplant guideline to assess donors and monitor recipients for human immunodeficiency virus (HIV), hepatitis B virus, and hepatitis C virus infections. This guideline reflects advances in transplant technology and safety that can increase the number of organs available for transplants. More information about the updated guidance can be found here.

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