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October 02, 2020

Health Law Weekly

COVID-19 Updates and Developments (Week of September 28)

  • October 02, 2020

House Democrats unveiled September 28 an updated version of their Health and Economic Recovery Omnibus Emergency Solutions (HEROES) Act as tentative negotiations between Speaker Nancy Pelosi (D-CA) and Treasury Secretary Mnuchin have resumed.

The updated HEROS Act trims the more than $3 trillion relief package House Democrats cleared in May to $2.2 trillion. The House cleared the revised measure on October 1 by a 214-207 margin. Pelosi said negotiations with the administration are ongoing. 

The renewed talks between House Democrats and the White House follows a $1.5 trillion COVID-19 stimulus measure that a bipartisan group of lawmakers unveiled earlier this month in an effort to restart stalled negotiations.

The Problems Solvers Caucus—a group of 50 House lawmakers divided equally between Democrats and Republicans—called the framework its “March to Common Ground.” The package includes some Democratic priorities, including more than $500 million in funding for state and local governments, though less than the nearly $1 billion in aid sought by House Speaker Nancy Pelosi (D-CA), and some Republican priorities, including liability protections for businesses.

In early September, Senate Republicans fell short of the votes needed to bring a pared-down COVID-19 relief measure to the floor. 

Agency Action

Department of Health and Human Services (HHS)

October 1—Hospitals can start purchasing Veklury (remdesivir), an antiviral drug that was shown in clinical trials to shorten recovery time for some patients, directly from the drug’s distributor, HHS announced. When supply was limited, the federal government had been overseeing the allocation and distribution of the drug to treat hospitalized patients with suspected or laboratory confirmed COVID-19. HHS said the drug is no longer in short supply so that oversight is no longer needed. The Food and Drug Administration revised October 1 the emergency use authorization for remdesivir, which is manufactured by Gilead Sciences, Inc., to authorize distribution directly to hospitals. Gilead anticipates producing enough of the drug to meet current needs and future demands. AmerisourceBergen will remain the sole distributor of Veklury through the end of the year, HHS said.

October 1—Health care providers can apply for $20 million in new relief funds starting October 5, HHS announced. The Phase 3 General Distribution is available to providers that already received provider relief funds for financial loses and changes in operating expenses caused by COVID-19. Previously ineligible providers, such as those who began practicing in 2020, and an expanded group of behavioral health providers also may apply for relief payments, the agency said. HHS has already issued more than $100 billion in relief funding to providers through prior distributions. 

September 30—HHS announced five cooperative agreements to health information exchanges (HIEs) for improving interoperability of health data for public health purposes. The HHS Office of the National Coordinator for Health Information Technology will administer the $2.5 million in Coronavirus Aid, Relief, and Economic Security Acts (CARES Act) funding to support local HIEs under the Strengthening the Technical Advancement and Readiness of Public Health Agencies via Health Information Exchange (STAR HIE) Program. The five HIE recipients—Georgia Health Information Network, Health Current (Arizona), HealthShare Exchange of Southeastern Pennsylvania, Kansas Health Information Network, Inc., and Texas Health Services Authority—will work to improve HIE services so that public health agencies can better access, share, and use health information during public health emergencies, including helping to support communities that are disproportionately impacted by COVID-19, HHS said.

Centers for Medicare & Medicaid Services (CMS)

September 30—Medicaid rolls swelled by nearly 4 million people between February and June during the public health emergency for COVID-19, a 6.2% increase, CMS reported. The Children’s Health Insurance Program saw enrollment increase by roughly 24,000, or 0.4%, during that time period.

September 29—CMS is updating how it calculates a county’s positivity rate for purposes of triggering nursing home testing requirements of their staff for COVID-19. Under CMS guidance issued in August, nursing homes must test staff for COVID-19 on a sliding scale that is tied to the community’s positivity rate. Some rural areas raised concerns that their positivity rates were skewed upward because they performed fewer tests overall, rather than being representative of actual positivity in the community. The new methodology categorizes counties with 20 or fewer tests over two weeks in the “green” category for COVID-19 community prevalence, meaning nursing homes don’t have to test staff for COVID-19 as frequently. Counties with both fewer than 500 tests and fewer than 2,000 tests per 100,000 residents, and greater than 10% positivity over 14 days—are now categorized as “yellow,” instead of their previous designation as “red,” which requires a greater frequency of testing.

September 25—CMS released a “quick-start guide” for laboratories to apply for Clinical Laboratory Improvement Amendment (CLIA) certification to test for COVID-19. The guide includes information on the expedited review process that allows labs to start COVID-19 testing before receiving official documentation of CLIA certification. Labs also have a new option to pay CLIA certification fees online, CMS said.

National Institutes of Health (NIH)

September 30—NIH awarded nearly $234 million to improve COVID-19 testing for underserved and vulnerable populations, including African Americans, American Indians/Alaskan Natives, Latinos/Latinas, Native Hawaiians, older adults, pregnant women and those who are homeless or incarcerated. The awards are aimed at better understanding testing patterns among underserved and vulnerable populations; strengthening the data on disparities in infection rates, disease progression and outcomes; and developing strategies to reduce disparities in COVID-19 testing.

Federal Communications Commission (FCC)

September 28—The FCC is extending the deadline from September 30 to December 31 for COVID-19 Telehealth Program funding recipients to purchase eligible devices and implement eligible services. The FCC said the extension gives funding recipients more time to purchase eligible items to provide telehealth services during the COVID-19 pandemic. In April, the FCC adopted a new $200 million program funded under the CARES Act to support health care providers’ use of telehealth during the coronavirus pandemic. The program is aimed at helping eligible health care providers purchase telecommunications, broadband connectivity, and devices necessary for providing telehealth services, the agency said. The FCC issued funding awards for 539 applicants, who were given until September 30 to purchase devices and implement telehealth services. The FCC said it decided to extend the purchase/implementation deadline until the end of the year following multiple requests for more time citing delays in procurement resulting from state law requirements, the COVID-19 pandemic, and other circumstances.

Other Developments

September 25—The recent change in COVID-19 reporting requirements could require many hospitals to return provider relief funds distributed under the CARES Act “based on a new formula and set of metrics that are simply unfair and unrealistic,” the American Hospital Association (AHA) said in a letter to HHS Secretary Alex Azar. Under frequently asked questions issued in June, HHS broadly defined “lost revenue” for purposes of accounting for provider relief funds as “any revenue that . . . a health care provider lost due to coronavirus.” The agency narrowed that definition, however, in a notice issued September 19. Under the more recent guidance, “lost revenue” is defined as “a negative change in year-over-year net patient care operating income,” which AHA said generally means, after covering the cost of COVID-19-related expenses, hospitals will only be able to apply provider relief fund payments toward lost revenue up to the amount of their 2019 net patient operating income. AHA urged the agency to reinstate the previous definition under the June FAQs. “For many, certainly, this lower lost revenue figure still will exceed their PRF payments. But for others, such as those that received substantial PRF payments and/or took aggressive and necessary steps to lower and contain costs during the pandemic, this new figure may be less than their payments, necessitating the return of funds,” AHA said, noting rural hospitals in particular are likely to be adversely affected under the new requirement. AHA also pointed out that the sudden shift in definition of COVID-19 related lost revenue “is extremely problematic” for hospitals not only from a budgeting/planning standpoint, but also for “accounting, auditing and bond rating purposes.”