Alston & Bird Healthcare Week in Review - July 2020 #3

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Below is Alston & Bird’s Healthcare 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, HHS adopted a final rule that changes the regulations governing the confidentiality of substance use disorder patient records. Read more about this rule and other news below.


I. Regulations, Notices, & Guidance

  • On July 13, 2020, the Food and Drug Administration (FDA) issued guidance entitled, Non-Clinical and Clinical Investigation of Devices Used for the Treatment of Benign Prostatic Hyperplasia. FDA has developed this draft guidance to propose select updates to certain sections of the existing FDA guidance document "Guidance for the Non‐Clinical and Clinical Investigation of Devices Used for the Treatment of Benign Prostatic Hyperplasia (BPH)." This draft guidance is not final nor is it in effect at this time.
  • On July 13, 2020, the U.S. Department of Health and Human Services (HHS) and the Substance Abuse and Mental Health Services Administration (SAMHSA) issued a final rule entitled, Confidentiality of Substance Use Disorder Patient Records. This final rule makes changes to the HHS regulations governing the confidentiality of substance use disorder patient records. These changes were prompted by the need to continue aligning the regulations with advances in the U.S. health care delivery system, while retaining important privacy protections for individuals seeking treatment for substance use disorders (SUDs). SAMHSA strives to facilitate information exchange for safe and effective SUD care, while addressing the legitimate privacy concerns of patients seeking treatment for a SUD. Within the constraints of the authorizing statute, these changes are also an effort to make the regulations more understandable and less burdensome.
  • On July 14, 2020, FDA issued guidance entitled, Clinical Investigations for Prostate Tissue Ablation Devices. This guidance provides recommendations for clinical investigations for high intensity ultrasound systems for prostate tissue ablation and new types of prostatic tissue ablation devices.
  • On July 14, 2020, FDA issued guidance entitled, Providing Regulatory Submissions for Medical Devices in Electronic Format—Submissions Under Section 745A(b) of the Federal Food, Drug, and Cosmetic Act. This guidance describes how FDA interprets and plans to implement the requirements of section 745A(b)(3) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), while individual guidances will be developed to specify the formats for specific submissions and corresponding timetables for implementation. Specifically, this guidance discusses: (1) the submission types that must be submitted electronically, (2) criteria for waivers of and exemptions from the submissions in electronic format requirements, and (3) the timetable and process for implementing the requirements.

Event Notices

  • July 21, 2020: HHS announced a public meeting entitled, Meeting of the Advisory Council on Alzheimer’s Research, Care, and Services. During the meeting, an invited panel will present on emergency preparedness for people with dementia with a special focus on the COVID-19 pandemic. The chairs of the subcommittees (Research, Clinical Care, and Long-Term Services and Supports) will present recommendations for adoption by the full Advisory Council.
  • 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 (HRSA) 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.
  • August 6, 2020: HHS announced a public meeting entitled, Meeting of the Presidential Advisory Council on HIV/AIDS. The purpose of the meeting is to discuss COVID-19 and HIV, and Ready, Set, PrEP enrollment.
  • 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.

II. Congressional Hearings

U.S. House of Representatives

  • On July 13, 2020, the House Committee on Appropriations held a markup of FY 2021 Labor, Health and Human Services, Education, and Related Agencies appropriations legislation. The legislation passed by a vote of 30 to 22.
  • On July 14, 2020, the House Committee on Homeland Security Subcommittee on Oversight, Management, and Accountability held a hearing entitled, Reviewing Federal and State Pandemic Supply Preparedness and Response. Witnesses present included: Craig Fugate, Senior Advisor, Blue Dot Strategies and Former Administrator, FEMA; Mr. Mark Ghilarducci, Director, Office of Emergency Services, Governor’s Office, California; and Mr. Chris Currie, Director, Homeland Security and Justice, U.S. Government Accountability Office (GAO).
  • On July 15, 2020, the House Committee on Energy and Commerce held a markup of 30 bills, including health legislation. All 30 bills passed.
  • On July 15, 2020, the House Committee on Budget held a hearing entitled, Software Update Required: COVID-19 Exposes Need for Federal Investments in Technology. Witnesses present included: Teresa Gerton, President and CEO, National Academy of Public Administration; Jennifer Pahlka, Founder, Code for America, and Co-Founder, U.S. Digital Response; Rebecca Dixon, Executive Director, National Employment Law Project; and Dr. Robert Wah, MD, Physician Leader in Healthcare and Technology.

III. Reports, Studies, & Analyses

  • On July 13, 2020, the Kaiser Family Foundation (KFF) published an issue brief entitled, Individual Insurance Market Performance in Early 2020. This brief analyzes first quarter data from 2011 through 2020 to examine how the individual insurance market performed under the Affordable Care Act (ACA) and during the first few months of the year, when the coronavirus pandemic was first emerging in the United States. The authors found that, on average, the individual market remained relatively stable through the first three months of 2020. Individual market insurers remained profitable, on average, as claims costs rose only slightly in the first three months of 2020. On average nationally, hospitalization rates, inpatient admissions, and physician encounters through March did not changed substantially compared to previous years. It is likely that the most significant impacts of the coronavirus outbreak and economic crisis on the individual market will not be evident nationally until data from the second and third quarters of 2020 become available.
  • On July 14, 2020, the Government Accountability Office (GAO) issued a report entitled, COVID-19: FEMA’s Role in the Response and Related Challenges. The Federal Emergency Management Agency (FEMA) Administrator, together with key officials from the Department of Health and Human Services, is responsible for managing the whole-of-nation COVID-19 pandemic response. This report addresses FEMA’s role in managing the COVID-19 pandemic, including efforts to acquire and distribute critical medical supplies, as well as potential challenges for this and other biological incident responses.
  • On July 15, 2020, KFF published an issue brief entitled, COVID-19 Test Prices and Payment Policy. This analysis examines what large hospitals nationwide charge for out-of-network COVID-19 tests. It finds a wide range of publicly posted prices—from $20 to $850 for a single test. In many cases, the prices exceed what Medicare pays for COVID testing.
  • On July 16, 2020, KFF published an issue brief entitled, Growth in Medicaid MCO Enrollment during the COVID-19 Pandemic. This analysis looks at state Medicaid managed care enrollment data from March 2019 and March 2020 as well as managed care enrollment data obtained from state websites for April and May 2020, to help begin to assess the impact of the COVID-19 pandemic and economic crisis on Medicaid enrollment.

IV. Other Health Policy News

  • On July 14, 2020, HHS announced a large-scale procurement of FDA-authorized, rapid point-of-care diagnostic test instruments and tests to be distributed to nursing homes in COVID-19 hotspot geographic areas with the U.S. This initiative is a one-time procurement of devices and tests targeted to facilitate on-site testing among nursing home residents and staff. Through this crucial action, nursing homes will be able to augment their current capacity for coronavirus testing, bolstering their response and helping to prevent the spread of SARS-CoV-2, the virus that causes COVID-19. More information about this initiative can be found here.
  • On July 17, 2020, HHS announced it will begin distributing $10 billion in a second round of high impact COVID-19 area funding to hospitals starting next week. This second round of funding was based on a formula for hospitals with over 161 COVID-19 admissions between January 1 and June 10, 2020, or one admission per day, or that experienced a disproportionate intensity of COVID admissions (exceeding the average ratio of COVID admissions/bed). Hospitals will be paid $50,000 per eligible admission. More information about the funding can be found here.

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DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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