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November 06, 2020

Health Law Weekly

COVID-19 Updates and Developments (Week of November 2)

  • November 06, 2020

Agency Action

Department of Health and Human Services (HHS)

November 2—HHS issued a clarification to post-payment reporting guidance for Provider Relief Funds (PRF), The current guidance, issued October 22, includes a two step process for providers to report their use of PRF payments: “1. Healthcare related expenses attributable to coronavirus that another source has not reimbursed and is not obligated to reimburse, which may include General and Administrative (G&A) or healthcare related operating expenses . . . .” and “2. PRF payment amounts not fully expended on healthcare related expenses attributable to coronavirus are then applied to patient care lost revenues, net of the healthcare related expenses attributable to coronavirus calculated under step 1. Recipients may apply PRF payments toward lost revenue, up to the amount of the difference between their 2019 and 2020 actual patient care revenue.” In a frequently asked question, HHS said that health care related expenses are no longer netted against the patient care lost revenue amount in Step 2. HHS indicated that a revised notice would be posted to remove the “net of the healthcare related expenses…” language in Step 2.

October 31—HHS announced a $12.7 million contract with Seattle-based InBios International to boost U.S. production of rapid COVID-19 tests. According to HHS, the deal will expand production capacity for two rapid point of care tests for COVID-19 to 400,000 units per week—20 times current output—by May 2021.

October 30—HHS announced a $119 million contract with Hologic Inc. to expand production capacity for COVID-19 tests in their supplier’s Wisconsin, Maine, and California facilities. Under the deal, the company will increase production capacity to 13 million COVID-19 tests per month by January 2022. 

Centers for Medicare & Medicaid Services (CMS)

October 30—CMS is centralizing information, guidance, and data available to nursing homes, providers, residents, and their families related to the COVID-19 pandemic through a new online platform—the Nursing Home Resource Center. "With the new page, people can efficiently navigate all facility inspection reports and data—including COVID-19 pandemic and PHE information,” CMS said.

Food and Drug Administration (FDA)

November 3—The FDA alerted clinical laboratory staff and health care providers that antigen tests for the rapid detection of the virus that causes COVID-19 could yield false positives. The FDA cited reports of false positive results for antigen tests used in nursing homes and other settings. The agency said it is continuing to monitor and evaluate the reports. The FDA recommended that labs and health care providers ensure they follow the manufacturer’s instructions for use, including for handling and storing the test. The agency also recommended considering performing confirmatory testing within 48 hours, particularly in counties with a low incidence of COVID-19 infections.

October 30—Working with federal partners, FDA has identified 319 “essential” medical products—223 drug and biologics and 96 device medical countermeasures—that should be available domestically at all times to adequately serve the nation’s patients. In August, President Trump issued an executive order that aimed to shore up the nation’s medical supply chain by requiring the federal government to buy certain critical drugs from American manufacturers. During the pandemic, health care providers have faced shortages for some drugs and supplies like masks and other protective gear that are mostly produced overseas. The order required the FDA to compile an initial list of “essential medicines, medical countermeasures and critical inputs” that the government should generally buy domestically.

Centers for Disease Control and Prevention (CDC)

November 2—CDC is considering partnering with one or more organizations to develop centralized public health laboratory data reporting from testing entities to state and local health departments. The agency issued a request for information to gauge the level of interest and obtain feedback that will be used to develop potential acquisition strategies. “CDC is seeking information from companies and other organizations about their capability, proven past performance, and capacity to leverage a secure and scalable cloud-based platform to accept and transmit testing data from testing entities to relevant state and large local health departments, with a focus on multi-state, large regional, and state-wide reporting entities,” the agency said. The Coronavirus, Aid, Relief, and Economic Security Act required labs to report COVID-19 test results to the CDC. In June, HHS issued guidance indicating that labs generally should submit testing data directly to state or local public health department, which then report the information to the CDC on a daily basis. CDC noted that a centralized platform could enable more widespread and accessible reporting.

Other Developments

October 28—Eighty-one percent of physicians in a recent national survey conducted by the American Medical Association (AMA) from July to August reported revenue was still lower than pre-pandemic levels. According to the survey results, medical practices have experienced a 32% average drop in revenue, with nearly one in five physicians reporting revenue reductions of 50% or greater. Eighty-one percent of physicians also reported providing fewer in-person patient visits than in February, with seven out of ten physicians providing fewer visits overall despite an uptick in telehealth visits. Total patient visits dropped 50% or greater for more than one out of five physicians, the survey found. At the same time, spending on personal protective equipment (PPE) jumped 50% or greater for nearly two out of five medical practice owners since February. Thirty-six percent of physicians, particularly in smaller practices, also reported struggling to acquire PPE. “Physician practices continue to be under significant financial stress due to reductions in patient volume and revenue, in addition to higher expenses for supplies that are scarce for some physicians,” said AMA President Susan R. Bailey, M.D. “More economic relief is needed now from Congress as some medical practices contemplate the brink of viability, particularly smaller practices that are facing a difficult road to recovery.”