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October 23, 2020

Health Law Weekly

COVID-19 Updates and Developments (Week of October 19)

  • October 23, 2020

The Department of Health and Human Services (HHS) is expanding the pool of eligible applicants for COVID-19 relief funding to a broad category of practices, including behavioral health providers, residential treatment facilities, chiropractors, and eye and vision providers regardless of whether they accept Medicare or Medicaid payments.  

On October 1, HHS announced $20 billion in new Phase 3 General Distribution funding for providers who previously received aid but needed additional financial support. Applications for the Phase 3 distribution are due November 6.

HHS also released updated guidance on post-payment reporting requirements after lawmakers and provider groups raised concerns about a recent change they said could put additional financial strain on hospitals, particularly safety net and rural providers.

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 that guidance, “lost revenue” is defined as “a negative change in year-over-year net patient care operating income.” HHS said the revised definition “sought to balance fairness and establish guardrails to restrict some providers from receiving distributions that would make them more profitable than they were before the pandemic."

The American Hospital Association (AHA), however, said the change could result in some hospitals having to return funds and undermine financial plans put in place under the original guidance. A bipartisan group of House and Senate lawmakers also urged the agency to reconsider the change.

HHS said it amended the reporting instructions to allow greater flexibility in how providers can use relief funds for lost revenue due to COVID-19.

“After reimbursing health care related expenses attributable to coronavirus that were unreimbursed by other sources, providers may use remaining [provider relief] funds to cover any lost revenue, measured as a negative change in year-over-year actual revenue from patient care related sources,” HHS said.

Agency Action

Food and Drug Administration (FDA)

October 22—The Food and Drug Administration approved Gilead Sciences Inc.’s antiviral drug Veklury (remdesivir) as a treatment for COVID-19 in hospitalized patients. The drug is the first treatment for COVID-19 to receive FDA approval. FDA cleared the drug for use in adult and pediatric patients 12 years of age and older who are hospitalized. The drug has been administered to patients in hospital settings under an emergency use authorization (EUA) that FDA issued in May. The agency said the approval applies to uses in a more limited population than under the EUA—the drug’s safety and efficacy is still being studied in children younger than 12 and below a certain weight. “Today’s approval is supported by data from multiple clinical trials that the agency has rigorously assessed and represents an important scientific milestone in the COVID-19 pandemic,” said FDA Commissioner Stephen M. Hahn, MD. The FDA said its approval was based on data from three randomized clinical trials in patients hospitalized with mild-to-severe COVID-19 that indicated the drug shortened recovery times.

Department of Health and Human Services

October 21—HHS issued guidance authorizing qualified pharmacy technicians and pharmacy interns to administer childhood vaccines, COVID-19 vaccines, and COVID-19 tests, subject to certain requirements. The guidance was issued under the Public Readiness and Emergency Preparedness Act (PREP Act). In September, HHS expanded the authority of state-licensed pharmacists and state-licensed registered pharmacy interns under the supervision of a qualified pharmacist to order and administer COVID-19 vaccinations to individuals three years of age and older under certain conditions. The latest guidance authorizes both qualified pharmacy techs and state-authorized pharmacy interns acting under the supervision of a qualified pharmacist to administer COVID-19 vaccinations to individuals three or older, and to administer other Food and Drug Administration-authorized or licensed vaccines to children three through 18, providing certain requirements are met, including that the vaccination was ordered by the supervising pharmacist, the pharmacist is immediately available, and the pharmacy tech or intern has completed a hands-on training program. The guidance clarifies that pharmacy interns must be authorized by the state but need not be licensed or registered. The guidance also authorizes pharmacy techs and interns to administer COVID-19 tests.

October 16—HHS announced agreements with CVS and Walgreens to provide and administer COVID-19 vaccines to residents of long term care facilities (LTCFs) when they become available. The Pharmacy Partnership for Long-Term Care Program will provide complete management of the COVID-19 vaccination process free of charge to facilities and with no out-of-pocket costs for residents, HHS said. The vaccination program will be available to all residents in long term care settings, and to LTCF staff who have not been vaccinated for COVID. In addition to managing the entire vaccination process, CVS and Walgreens pharmacies also will be required to report vaccination data to state, local, and federal public health officials within 72 hours of administering each dose. LTCFs can opt into the program starting October 19 and indicate which pharmacy they prefer to have onsite.

Office for Civil Rights

October 20—OCR resolved religious discrimination complaints against two hospitals—MedStar’s Southern Hospital Center (MSMHC) and Mary Washington Healthcare (MWHC) in Virginia. For MSMHC, which is part of the MedStar Health System, OCR received a complaint from a mother after the hospital refused her request for a Catholic priest to visit her newborn son and baptize him. The mother had been separated from her newborn because she had tested positive for COVID-19. According to the complaint, the hospital had adopted a no-visitor policy in response to the COVID-19 pandemic. OCR resolved the complaint after MedStar Health System updated its visitation policy for all ten of its hospitals, including MSMHC, ensuring clergy access to patients for religious purposes, provided the visits do not disrupt patient care and clergy follow hospital safety policies and infection control practices. Regarding MWHC, the Diocese of Arlington, VA filed a complaint with OCR alleging the hospital refused to allow a priest to provide Catholic religious sacraments to a COVID-positive patient who was in an end-of-life situation. Following the complaint, and given the urgency of the situation, MWHC did allow the priest access to the patient to provide the sacraments, but subsequently refused to allow clergy to visit non-COVID patients in its ICU except for end-of-life situations. After a second complaint from the Diocese of Arlington, MWHC adopted a new policy that allows patients in COVID units access to clergy in compassionate care situations provided they complete infection control training, use fit-tested personal protective equipment, and sign an acknowledgment of the risks. If the urgency of the situation makes these steps impractical, clergy will be allowed to see a patient but must self-quarantine for 14 days. Patients in non-COVID units also may receive clergy visitation provided those services can be provided without disrupting care.

Other Developments

October 21—Several prominent health care provider groups are urging congressional leaders to pass legislation to extend a moratorium on Medicare sequester cuts through the duration of the COVID-19 public health emergency (PHE). The Coronavirus Aid, Relief, and Economic Security Act included a reprieve for Medicare providers from the 2% sequester cut through 2020. “Clearly Congress recognized the importance of this relief for the duration of the PHE,” the groups said in a letter to House and Senate lawmakers. "Without future sequestration relief, America’s health care safety net could be at further risk of collapse. As such, we respectfully ask that Congress pass legislation this year that further postpones the application of this harmful 2% cut for the duration of the PHE in 2021,” the groups said. The letter was signed by AHA, the American Medical Association, the American Health Care Association, and the National Association for Home Care & Hospice.