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COVID-19: Updates and Developments (Week of May 4)

  • May 08, 2020

The Food and Drug Administration (FDA) is ramping up oversight of commercial manufacturers that are developing antibody testing for COVID-19 to address a rising number of faulty tests.

The agency is updating a March 16 policy document that provided more regulatory flexibility for serology test developers.

In a May 4 statement, the agency noted the flexibility under the earlier policy was never meant to allow fraud. “We unfortunately see unscrupulous actors marketing fraudulent test kits and using the pandemic as an opportunity to take advantage of Americans’ anxiety. Some test developers have falsely claimed their serological tests are FDA approved or authorized. Others have falsely claimed that their tests can diagnose COVID-19 or that they are for at-home testing, which would fall outside of the policies outlined in our March 16 guidance, as well as the updated guidance,” Anand Shah, M.D., Deputy Commissioner for Medical and Scientific Affairs, and Jeff Shuren, M.D., Director, Center for Devices and Radiological Health, said in the statement.

Under the updated policy, commercial manufacturers must submit emergency use authorization (EUA) requests to FDA within ten days of releasing the product. The policy also provides specific performance threshold recommendations for specificity and sensitivity for all serology test developers.

To date, 12 antibody tests have been authorized under an individual EUA, and more than 200 antibody tests are currently under review for an EUA, the agency reported.

Department of Health and Human Services (HHS)

May 7—HHS is extending the deadline to 45 days for health care providers to attest to receipt of Provider Relief Fund payments and accept the terms and conditions. The deadline, which previously was 30 days, starts from the date providers receive payment. The Coronavirus Aid, Relief, and Economic Security Act (CARES Act) and Paycheck Protection Program and Health Care Enhancement Act provided $175 billion in aid to hospitals and health care providers to support expenses or lost revenue attributed to COVID-19 and to cover virus testing and treatment for uninsured Americans.

May 7—HHS awarded nearly $583 million to 1,385 community health centers across the country to expand COVID-19 testing. “Widespread testing is a critical step in reopening America, and health centers are vital to making testing easily accessible, especially for underserved and minority populations. Further, because health centers can help notify contacts of patients who test positive, they will continue playing an important role in cooperating with state and local public health departments,” said HHS Secretary Alex Azar.

May 6—HHS issued updated Frequently Asked Questions (FAQs) on the Provider Relief Fund. According to the updated FAQs, HHS generally does not intend to recoup funds as long as a provider’s lost revenue and increased expenses exceed the amount of Provider Relief funding a provider has received, although the agency is reserving the right to conduct future audits. The updated FAQs also discuss oversight and enforcement mechanisms which HHS use to ensure providers meet the Terms and Conditions of the Provider Relief Fund payment and the definition of individuals with possible or actual cases of COVID-19.

May 1—HHS is starting targeted distributions of Provider Relief Funds to hospitals with high COVID-19 admissions and to rural providers. The agency said $12 billion will be distributed to 395 hospitals with large numbers of COVID-19 inpatient admissions (100 or more) through April 10. Two billion of the distribution will be based on hospitals’ Medicare and Medicaid disproportionate share and uncompensated care payments, HHS said. An additional $10 billion will be distributed to providers in rural areas, including rural acute care general hospitals, Critical Access Hospitals, Rural Health Clinics, and Community Health Centers. The agency previously announced general distributions from the Provider Relief Fund totaling $50 billion.

May 1—HHS’ Office of Minority Health is investing up to $40 million to help support the delivery of COVID-19-related information to minority, rural, and socially vulnerable communities. The three-year initiative is aimed at developing a network of national, state, local, and community-based organizations to help mitigate the impact of COVID-19 on racial and ethnic minority communities across the nation. The agency is accepting applications for the competitive funding opportunity by May 11.

Centers for Medicare & Medicaid Services (CMS)

May 6—CMS issued guidance for nursing homes on new reporting requirements for nursing homes with confirmed or suspected COVID-19 cases. In mid-April, CMS announced that nursing homes would be required to inform residents and their representatives of COVID-19 cases in their facilities. CMS also mandated that nursing homes report confirmed or suspected cases of COVID-19 directly to the Centers for Disease Control and Prevention (CDC) in a standardized format. Nursing homes must report the first week of COVID-19 data to CDC beginning May 8 but no later than May 17, CMS said. The agency indicated that the data reported to CDC would be publicly posted “so all Americans have access to accurate and timely information on COVID-19 in nursing homes.”

Food and Drug Administration

May 1—FDA issued to Gilead Sciences Inc. an EUA for the investigational antiviral drug remdesivir as a potential treatment of suspected or laboratory-confirmed COVID-19 in hospitalized patients with severe disease. Remdesivir was shown in a clinical trial to shorten the time to recovery in some patients, FDA said. The EUA allows remdesivir to be distributed in the United States and administered intravenously by health care providers to treat COVID-19 patients with low blood oxygen levels or needing oxygen therapy or more intensive breathing support.

Office for Civil Rights (OCR)

May 5—OCR is reminding health care providers that giving the media and film crews access to their facilities where personal health information (PHI) is accessible (including written, electronic, oral, or visual or audio) without prior written authorization from patients violates the Health Insurance Portability and Accountability Act Privacy Rule. In additional guidance, OCR underscored that blurring or otherwise obscuring patients’ faces in videos after the fact is not permissible without first obtaining prior, express patient authorizations. For example, a covered hospital may not allow media personnel access to the emergency department where patients are receiving treatment for COVID-19, without first obtaining each patient’s authorization for such filming,” the guidance noted. Even with valid HIPAA authorizations, covered entities must put reasonable safeguards in place to protect against unauthorized disclosures. “The last thing hospital patients need to worry about during the COVID-19 crisis is a film crew walking around their bed shooting ‘B-roll,’” said Roger Severino, OCR Director.  “Hospitals and health care providers must get authorization from patients before giving the media access to their medical information; obscuring faces after the fact just doesn’t cut it,” Severino added.

Other Developments

May 5—Two lawmakers from Pennsylvania are urging the Centers for Medicare & Medicaid Services (CMS) to increase the frequency and intensity of nursing home inspections. “With the new risks posed by COVID-19, and the absence of visiting family members, the current CMS inspection cycle of 9 -15 months is inadequate,” Representatives Mike Doyle (D-PA) and Conor Lamb (D-PA) said in May 5 letter to HHS Secretary Alex Azar and CMS Administrator Seema Verma. The lawmakers cite Brighton Rehabilitation and Wellness Center in Western Pennsylvania, which according to the letter has over 400 presumed positive residents and more than 60 COVID-19-related deaths, as a “concrete example” of why more inspections are needed. “I believe that more frequent inspections—along with additional resources for testing, treatment, and personal protective equipment—would go a long way towards ensuring that senior care facilities live up to their responsibilities to protect their residents from deadly threats like COVID-19,” Doyle said in a statement. The letter comes as the Pennsylvania Department of Health is facing a class action alleging its failure to conduct required inspections of long term care facilities is putting nursing home residents at risk. According to a complaint filed April 28 in the U.S. District Court for the Eastern District of Pennsylvania, inspections “have come nearly to a halt,” increasing the risk of COVID-19 transmission. The lawsuit also alleges that the failure to inspect has allowed “apparent biomedical experimentation on residents under the guise of clinical trials.” The named plaintiff in the case, the daughter of a Brighton Rehabilitation and Wellness Center resident, said she was “coerced” into signing a “consent” form for her father involving a drug study to determine whether the combination of hydroxychloroquine and zinc would prevent infection with COVID-19.

May 5—The American Hospital Association (AHA) released a report estimating that over the four-month period from March 1 to June 30, the nation’s hospitals and health systems will lose $202.6 billion, an average of $50.7 billion per month, because of the COVID-19 pandemic. Citing a steep decline in hospital revenue because of cancelled non-emergency procedures and a sharp increase in costs for supplies and labor, including additional supports for frontline health care workers like childcare, the report said hospitals are facing “catastrophic financial challenges.” The group is urging Congress to provide additional support beyond the $175 billion allocated for the Provider Relief Fund, which also will be devoted in part to testing and treatment costs for the uninsured.

May 4—House Ways and Means Health Subcommittee Chairman Lloyd Doggett (D-TX) and other Democratic lawmakers sent a letter to Gilead CEO Daniel O’Day asking about the company’s plans to ensure remdesivir, an antiviral drug that has emerged as a potential therapy for COVID-19, is available and affordable. Specifically, Doggett wants the company to detail how it will secure the supply chain, the extent of public money used to develop the drug, and what purchase and pricing arrangements Gilead is making for future supplies of remdesivir. According to Doggett, American taxpayers have made a significant investment in remdesivir. “In pricing remdesivir for the desperate, both the amounts of that production cost and the taxpayer investment should be fully disclosed and factored into pricing decisions,” the letter said. FDA recently granted emergency use authorization for remdesivir.