Health Care Week in Review August 7, 2020

Alston & Bird Health Care Week in Review, August 7, 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 Tuesday, CMS issued its annual proposed updates to the Medicare Outpatient Prospective Payment System and Physician Fee Schedule. Read more about the proposed rules and other news below.


I. Regulations, Notices, & Guidance

Event Notices

  • August 11, 2020: FDA announced a public meeting entitled, Independent Third-Party Assessment of IND FDA-Sponsor Communication Practices in PDUFA VI. The meeting will include a presentation from an independent third-party contractor about its assessment of FDA-sponsor communications during the investigational new drug (IND) stage of drug/biologic development in the Prescription Drug User Fee Act (PDUFA) VI; a series of presentations by and a panel discussion with invited regulatory and industry representatives, and an open public comment period.
  • August 13, 2020: FDA announced a public meeting entitled, Meeting of the Oncologic Drugs Advisory Committee. The committee will discuss biologics license application 125706, for remestemcel-L (ex-vivo culture-expanded adult human mesenchymal stromal cells suspension for intravenous infusion), submitted by Mesoblast, Inc. The proposed indication for this product is for the treatment of steroid-refractory acute graft-versus-host disease in pediatric patients.
  • August 19, 2020: The Substance Abuse and Mental Health Services Administration (SAMHSA) announced a public meeting entitled, Meeting of the Advisory Committee for Women’s Services. The meeting will include discussions on assessing SAMHSA’s current strategies, including the mental health and substance use needs of the women and girls’ population. Additionally, the ACWS will be addressing priorities regarding the impact of COVID-19 on the behavioral health needs of women and children, and the current ethnic/racial climate and related economic and health disparities on women, and directions around behavioral health services and access for women and children.
  • August 26, 2020: The Centers for Disease Control and Prevention (CDC) announced a public meeting entitled, Meeting of the Advisory Committee on Immunization Practices (ACIP). The agenda will include discussions on COVID-19 vaccines.
  • August 31, 2020: CMS announced a public meeting entitled, Meeting of the Advisory Panel on Hospital Outpatient Payment. The purpose of the Panel is to advise the Secretary of the Department of Health and Human Services (HHS) and the CMS Administrator concerning the clinical integrity of the Ambulatory Payment Classification groups and their associated weights, and supervision of hospital outpatient therapeutic services. The advice provided by the Panel will be considered as CMS prepares the annual updates for the hospital outpatient prospective payment system.
  • September 8-9, 2020: FDA announced a public meeting entitled, Meeting of the Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee. During the meeting, the committee will discuss the classification of several medical devices.
  • September 15, 2020: FDA announced a public meeting entitled, Meeting of the Pediatric Advisory Committee. The committee will discuss pediatric-focused safety reviews, as mandated by the Best Pharmaceuticals for Children Act (Pub. L. 107-109) and the Pediatric Research Equity Act of 2003 (Pub. L. 108-155).
  • September 23-24, 2020: HHS announced a public meeting entitled, Meeting of the National Vaccine Advisory Committee (NVAC). During the September 2020 NVAC meeting, sessions will focus on future coronavirus vaccines, the upcoming flu season, immunization equity, and routine vaccination.

II. Congressional Hearings

U.S. House of Representatives

  • On August 6, 2020, the House Committee on Oversight and Reform Subcommittee on the Coronavirus Crisis held a hearing entitled, Challenges to Safely Reopening K-12 Schools. Witnesses present included: The Honorable Arne Duncan, Managing Partner, Emerson Collective, Former Secretary of Education; Dr. Caitlin Rivers, Senior Scholar, Johns Hopkins Center for Health Security, Assistant Professor, Department of Environmental Health and Engineering, Johns Hopkins Bloomberg School of Public Health; Robert W. Runcie, Superintendent, Broward County Public Schools; and Angela Skillings, Teacher, Hayden Winkelman Unified School District.
  • On August 6, 2020, the House Committee on Ways and Means Rural and Underserved Communities Health Task Force held a roundtable entitled, Examining the Role of Telehealth During COVID-19 and Beyond. Panelists included: Tearsanee Carlisle Davis, DNP, FNP-BC, FAANP, Director of Clinical and Advanced Practice Operations at the University of Mississippi Medical Center’s Center (UMMC) for Telehealth, Assistant Professor at UMMC School of Nursing; Dr. Ateev Mehrotra, MD, MPH, Associate Professor of Health Care Policy, Department of Health Care Policy, Harvard Medical School, Associate Professor of Medicine and Hospitalist, Beth Israel Deaconess Medical Center; Keris Myrick, MBA, Chief of Peer and Allied Health Professions for the Los Angeles County Department of Mental Health; and Dr. Jason Tibbels, MD, Chief Quality Officer for Teladoc and Founder and Vice President of the Institute of Patient Safety and Quality of Virtual Care.

III. Reports, Studies, & Analyses

  • On August 3, 2020, Kaiser Family Foundation (KFF) published an issue brief entitled, Key Questions About Nursing Home Regulation and Oversight in the Wake of COVID-19. The COVID-19 pandemic has led to renewed interest in nursing home regulation and oversight, as residents and staff are at increased risk of infection due to the highly transmissible nature of the coronavirus, the congregate nature of facility settings, and the close contact that many workers have with patients. Certification of nursing home compliance with federal Medicare and/or Medicaid requirements generally is performed by states through regular inspections known as surveys. Federal regulations issued in 2016 require facilities to have an infection control and prevention program and a written emergency preparedness plan. This issue brief answers key questions about nursing home oversight and explains how federal policy has changed in light of COVID-19.
  • On August 3, 2020, KFF published an issue brief entitled, What We Know About Provider Consolidation. This brief provides an overview of existing research that examines the impact of provider consolidation on health care costs and quality. There are two major types of consolidation among health care providers, both of which are discussed in this brief. The first is horizontal consolidation, which occurs when two providers performing similar functions join, such as when two hospitals merge or groups of physician practices merge to form larger group practices. The second type is vertical integration, which refers to one type of entity purchasing another in the supply chain such as hospitals acquiring physician practices.
  • On August 4, 2020, RAND Corporation published a report entitled, Practice Expense Methodology and Data Collection Research and Analysis. In this report, the authors address how CMS can improve the methodology or update data used for setting practice expense (PE) rates for payments made under the Medicare PFS. The current system for setting PE payment rates relies, in part, on data collected in the Physician Practice Information (PPI) Survey, which generally reflects information from 2006. Because of changes in the U.S. economy and health care system since that time, there are concerns that continued reliance on measures that use PPI Survey data might result in misvalued PE rates. To the extent that future payment systems use PFS rates as a starting point, misvalued PE rates might be problematic if they are not updated. The research in this report, which is part of the second phase of a study, can be divided into three broad topics. First, the authors consider how updated PE data could be collected through a new large-scale national survey effort to replace the PPI Survey. Second, the authors consider a new framework for allocating PE, which they developed to better capture variation in PE resources that are required to provide services covered in the Medicare PFS. Finally, the authors continue work begun in Phase I of the project and documented in a previous report, Practice Expense Methodology and Data Collection Research and Analysis, investigating the potential to make use of data collected to set rates in the OPPS.

IV. Other Health Policy News

  • On August 3, 2020, President Trump signed an executive order calling on CMS to make permanent some telehealth provisions allowed during the COVID-19 pandemic as well as authorize the Center for Medicare and Medicaid Innovation (CMMI) to create a rural health payment model. The executive order also calls on HHS to submit a report to the White House on existing and upcoming policy initiatives related to increasing access to health care for rural patients by eliminating regulation on the availability of providers; reducing maternal mortality and morbidity; and improving mental health care in rural communities. Finally, it calls on HHS and the Federal Communications Commission to develop and implement a strategy to improve rural communications health care infrastructure. More information on this executive action can be found here.
  • On August 6, 2020, President Trump signed an executive order to encourage the production of certain drugs and medical supplies in the U.S. following shortages during the COVID-19 pandemic. The order calls on purchasers to buy American-made products and loosens federal drug-safety and environmental regulations that the administration says disadvantage domestic producers, among other measures. More information on the order can be found here.
  • On August 6, 2020, HHS, through the Health and Resources and Services Administration (HRSA), awarded over $101 million to combat substance use disorders (SUD) and opioid use disorders (OUD). The awards support 116 organizations in 42 states and the District of Columbia, with many targeting high-risk rural communities. More information about this funding can be found here.

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

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