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July 24, 2020

Health Law Weekly

COVID-19 Updates and Developments (Week of July 20)

  • July 24, 2020

As cases of COVID-19 climb in a number of states, the Centers for Medicare & Medicaid Services (CMS) announced July 22 new steps aimed at helping nursing homes avoid major outbreaks.

One of these steps is to require nursing homes in states with a 5% or greater positivity rate to test all staff on a weekly basis. To help support the new requirement, CMS plans to deploy more than 15,000 testing devices over the next few months, with an initial 600 testing devices going out this week.

CMS also is devoting an additional $5 billion in Provider Relief Funds under the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) to nursing homes for hiring more staff, infection control, increased testing, and acquiring technology so residents can connect with family members virtually. The funding is in addition to the $4.9 billion CMS previously provided to nursing homes to offset revenue losses and to respond to COVID-19.

Federal Task Force Strike Teams also are providing onsite technical assistance and education to nursing homes on keeping COVID-19 out of their facilities, detecting COVID-19 cases quickly, preventing virus transmission, and managing staff, CMS said.

These teams, which include clinicians and public health officials from CMS, the Centers for Disease Control and Prevention (CDC), and the Department of Health and Human Services (HHS), recently were deployed to 18 nursing homes in Illinois, Florida, Louisiana, Ohio, Pennsylvania, and Texas based on self-reported data indicating an increase in COVID-19 cases.

In addition, CMS and the CDC are launching online, on-demand Nursing Home Covid-19 Training modules focused on infection control and best practices.

Meanwhile, on July 23, Department of Health and Human Services (HHS) Secretary Alex Azar renewed the public health emergency (PHE) for COVID-19. Azar declared the PHE at the end of January and previously extended it in April. The PHE was set to expire on July 25. 

Agency Action

Department of Health and Human Services 

July 22—The federal government will pay $1.95 billion to U.S.-based Pfizer Inc. and BioNTech, a German biotechnology company, for 100 million doses of a COVID-19 vaccine, HHS announced. The companies are collaborating to develop COVID-19 investigational vaccines with Phase I/II clinical trials underway in both countries. The deal will allow the government to acquire the vaccine quickly if the Food and Drug Administration (FDA) grants an Emergency Use Authorization (EUA) or licensure, HHS noted. The agreement is part of the government’s Operation Warp Speed initiative to deliver 300 million doses of safe and effective vaccine by the end of the year. The agreement includes an option to acquire 500 more doses. According to HHS, the vaccine will be available to the American people at no cost.

July 21—HHS announced a new program to help gather and share feedback from the private sector on how the federal government can best identify and address testing supply chain issues and define optimal testing in various settings. The National Testing Implementation Forum is aimed at significantly increasing public health laboratory capacity, implementing a national surveillance strategy, seeking new techniques and technologies, and identifying barriers to a streamlined lab testing reporting system and standards, HHS said. The Forum also will work to improve targeted testing among vulnerable and underserved populations.

July 20—HHS issued a notice on reporting requirements for health care providers that receive one or more payments exceeding $10,000 in the aggregate from the Provider Relief Fund under the CARES Act. In the notice, HHS said it plans to issue detailed reporting instructions by August 17. The Terms and Conditions for payments from the relief fund require each recipient to submit reports to HHS demonstrating the funding was used for allowable purposes. HHS plans to make the reporting system available on October 1. All recipients must report within 45 days of the end of calendar year 2020 on their expenditures through December 31.

July 17—HHS is distributing $10 billion in additional provider relief funds to hospitals in areas hit hard by COVID-19. The CARES Act and subsequent legislation allotted $175 billion to help ease the financial strain on health providers in the wake of the COVID-19 pandemic. In May, HHS distributed an initial $12 billion in funding to hospitals in “high impact” areas. HHS said the second round of funding to this group will provide relief to more than 1,000 hospitals nationwide. Funding allocations are based on data that hospitals submitted on their COVID-19 positive-inpatient admissions from January 1 through June 10. Hospitals with more than 161 COVID-19 admissions during the six-month time period will be paid $50,000 per eligible admission.

Office for Civil Rights (OCR)

July 21—OCR resolved religious discrimination complaints against two hospitals—Prince George’s Hospital Center of the University of Maryland Medical System (UMMS) and Staten Island University Hospital (SIUH) in New York City. For UMMS, OCR received a complaint from a patient’s wife after Prince George’s Hospital Center denied her request for a priest to visit her critically injured husband. The hospital had adopted a no-visitor policy in response to the COVID-19 pandemic. OCR resolved the complaint after UMMS, which oversees Prince George’s Hospital Center, adopted new policies ensuring clergy access to patients for religious purposes. In addition to allowing the priest to visit the patient in question, UMMS updated its visitation policy for all 13 of its hospitals so that patients will have access to chaplains or clergy. Visiting clergy must follow hospital safety policies and sign a written waiver. Regarding SIUH, OCR received a complaint about a medical student who the hospital refused to allow back for rotations unless he shaved his beard, even though he passed an N95 fit test. The student doesn’t shave his beard because of his religious beliefs. OCR resolved the complaint after SIUH accommodated the student by providing an alternative form of personal protective equipment that offers greater protection than an N95 mask would allow for a facial beard.

July 20—OCR issued guidance on complying with Title VI of the Civil Rights Act of 1964 during the COVID-19 pandemic. The guidance, among other things, advises recipients of federal financial assistance, which includes state and local agencies, hospitals, and other health care providers, to ensure testing sites for COVID-19 are accessible to racial and ethnic minority populations and that existing policies and procedures do not exclude or deny individuals on the basis of race, color, or national origin. "HHS is committed to helping populations hardest hit by COVID-19, including African-American, Native American, and Hispanic communities,” said OCR Director Roger Severino. "This guidance reminds providers that unlawful racial discrimination in healthcare will not be tolerated, especially during a pandemic."

Food and Drug Administration 

July 18—FDA reissued an EUA to Quest Diagnostics for its Quest SARS-COV-2rRT-PRC test for use with pooled samples containing up to four individual swab specimens collected under observation. The Quest test is the first COVID-19 diagnostic test to be authorized for use with pooled samples, FDA said. Sample pooling allows multiple people to be tested at once. The samples—in this case from four individuals—can be tested in a pool or “batch” using one test, rather than running each individual sample on its own test. If the pool is positive, then each sample is tested to pinpoint the individuals in the batch who are positive. “This EUA for sample pooling is an important step forward in getting more COVID-19 tests to more Americans more quickly while preserving testing supplies,” said FDA Commissioner Stephen M. Hahn, M.D.

Other Developments

July 22—Groups representing physicians, hospitals, and nurses are urging lawmakers to include at least $100 billion in additional funding for frontline health care providers in the next round of stimulus legislation. In a letter to Senate Majority Leader Mitch McConnell (R-KY) and Minority Leader Charles Schumer (D-NY), the groups said the spike in COVID-19 cases in numerous states is continuing to stress the health care system, with health care providers incurring additional costs for equipment, supplies, and staff and experiencing lost revenue due to the decrease in inpatient and outpatient services. “We ask that Congress direct the Department of Health and Human Services to infuse these funds as soon as possible so that health care providers can continue to provide care to their patients and communities,” the letter said, which was signed by the American Hospital Association (AHA), American Medical Association, and the American Nurses Association.

July 21—The Senate Special Committee on Aging held a hearing on COVID-19 and seniors that focused on racial disparities. Dominic H. Mack, MD, MBA, National Center for Primary Care Director and a professor at Morehouse School of Medicine, told the panel that Congress in the next round of COVID-19 stimulus legislation should resolve the funding disparity from the CARES Act that short-funded the Historically Black Graduate Institutions; expand funding for improving and developing health care infrastructure in medically underserved communities; and double funding for existing Title VII health professions training programs that target increasing diversity in the health care workforce. The federal government also should “invest $100 million in new, annual research funding dedicated through the NIH’s National Institute on Minority Health and Health Disparities, specifically targeted at enabling minority-serving institutions to conduct research that is responsive to reversing the health disparities associated with the existing COVID-19 pandemic, and preventing the next episode from taking a similar toll,” Mack said. Eugene A. Woods, MBA, MHA, FACHE, the President and CEO of Atrium Health, made a series of policy recommendations, including permanently extending coverage for telemedicine services, which he said “is essential to reducing health disparities.”

July 20—House Ways and Means Committee Republicans released a discussion draft of legislation to make permanent certain changes to Medicare rules for telehealth that were eased during the COVID-19 pandemic to allow more patients to receive care virtually. According to a summary of the discussion draft, the measure would remove geographic and originating site restrictions; allow certain clinical practitioners like physical therapists, speech pathologists, and occupational therapists, to provide care via telehealth; and allow telehealth services through audio-only telephone, when audio-visual isn’t an option and where the patient and provider have an established relationship. Senate Finance Committee Ranking Member Ron Wyden (D-OR) proposed separate legislation also aimed at permanently expanding the availability of telehealth services in Medicare. The measure, among other things, would make mental health services and evaluation and management services available through telehealth to all Medicare beneficiaries. The measure also would eliminate statutory geographic restrictions and expand the available originating sites for telehealth services.