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August 21, 2020

Health Law Weekly

COVID-19 Updates and Developments (Week of August 17)

  • August 21, 2020

Agency Action

Department of Health and Human Services (HHS)

August 19—HHS amended the declaration of liability immunity under the Public Readiness and Emergency Preparedness Act to authorize state-licensed pharmacists to order and administer vaccines to children. "Today's action means easier access to lifesaving vaccines for our children, as we seek to ensure immunization rates remain high during the COVID-19 pandemic,” said HHS Secretary Alex Azar. The Centers for Disease Control and Prevention (CDC) reported in May a drop in routine childhood immunizations as families stayed at home because of the pandemic. The PREP Act authorizes the HHS Secretary to provide liability immunity to certain individuals and entities for claims arising out of medical countermeasures, excluding claims involving ‘‘willful misconduct.’’ The American Academy of Pediatrics pushed back on the move, calling it misguided. “This unprecedented expansion of pharmacies’ ability to administer vaccines to children is not a solution to the vaccine hesitancy that is driving down rates of childhood immunizations in the U.S.," said AAP President Sally Goza, MD, FAAP in a statement.  

August 14—HHS and the Department of Defense announced that, pursuant to an already existing contract, McKesson Corporation will be a central distributor of future COVID-19 vaccines and related supplies. According to a press release, CDC is executing an existing contract option with McKesson to support vaccine distribution as part of the administration's Operation Warp Speed initiative.

August 14—HHS announced plans to begin distributing $1.4 billion in targeted distribution funding to almost 80 children’s hospitals nationwide. According to HHS, children’s hospitals have seen decreasing patient visits and increased costs as a result of the pandemic. To qualify for the funding under the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) and the Paycheck Protection Program and Health Care Enhancement Act, which allocated $175 billion in relief funds to hospitals and other health care providers, qualifying free-standing children’s hospitals must either be an exempt hospital under the Centers for Medicare and Medicaid Services (CMS) inpatient prospective payment system or a Health Resources and Services Administration defined Children’s Hospital Graduate Medical Education facility. Eligible hospitals will receive 2.5% of their net revenue from patient care, HHS said.

Centers for Medicare & Medicaid Services

August 17—CMS updated guidance to Inpatient Prospective Payment System hospitals, long term care hospitals, and inpatient rehabilitation facilities to specify that, effective with admissions occurring on or after September 1, 2020, claims eligible for increased reimbursement under the CARES Act will be required to have a positive COVID-19 laboratory test documented in the patient’s medical record. CMS said it added the requirement to address potential Medicare program integrity risks.

August 17—CMS issued guidance on resuming routine inspections of all Medicare and Medicaid certified providers and suppliers. The agency previously suspended certain routine inspections as part of its COVID-19 response to prioritize infection control and immediate jeopardy situations and to give health care providers and suppliers time needed to respond to the spread of COVID-19.

August 17—CMS posted updates to its Toolkit on State Actions to Mitigate COVID-19 Prevalence in Nursing Homes. According to the agency, the toolkit details actions and best practices by organizations, state governments nationwide, and U.S. territories to assist nursing homes in meeting the needs of nursing home residents since the onset of the pandemic. 

August 17—CMS released guidance that provides a checklist of key actions dialysis facilities should take when there is a surge or resurgence of COVID-19 in their surrounding communities. The guidance, Key Components for Continued COVID-19 Management for Dialysis Facilities, also directs providers to resume planned surgical procedures essential to patient quality of care when possible. The agency previously released guidance to defer nonessential planned surgical procedures as part of its pandemic response, but the updated policy memorandum clarifies that essential surgical procedures such as vascular access and organ transplant procedures are critical for End State Renal Disease patients to receive life-sustaining treatment while also recognizing there will be instances in which local conditions will not allow for these procedures to be performed.

August 14—CMS announced that it imposed over $15 million in civil money penalties (CMPs) to more than 3,400 nursing homes during the public health emergency for noncompliance with infection control requirements and the failure to report COVID-19 data. At the beginning of the pandemic, CMS prioritized surveys to focus on the most serious health and safety threats. Since March 4, 2020, CMS and state survey agencies have completed infection control surveys in over 15,276 (99.2%) of nursing homes, the agency noted. Those surveys have resulted in more than 180 immediate jeopardy level findings for infection control, which is triple the rate of such deficiencies found in 2019. CMS said it imposed CMPs for these violations totaling nearly $10 million to nursing homes in 22 states. The average CMP imposed was $55,000. In addition, as of August 3, CMS has cited more than 3,300 deficiencies and imposed more than $5.5 million in CMPs to nursing homes for failing to report required COVID-19-related data to the CDC.

Office for Civil Rights

August 20—OCR resolved a complaint filed against Utah after it revised its crisis standards of care (CSC) plan to ensure individuals don’t face discrimination based on disability or age if the state needs to ration medical resources. The resolution is the fifth that OCR has reached with states concerning guidelines for rationing health care resources. In April, OCR issued a bulletin reminding covered entities that they must continue to comply with federal civil rights laws during the COVID-19 public health emergency. OCR enforces the Americans with Disabilities Act, Section 504 of the Rehabilitation Act, the Age Discrimination Act, and Section 1557 of the Affordable Care Act. OCR said it received a complaint from Disability Law Center alleging provisions of Utah's 2018 CSC guidelines and its 2020 Annex discriminate based on disability and would automatically disqualify individuals with certain diseases and other disabilities from receiving lifesaving care during a public health emergency if resources were scarce. To resolve the complaint, the state removed categorical exclusion criteria on the basis of age, disability, and functional impairment; removed language allowing a patient’s long term life expectancy to be used as a factor in resource allocation; and incorporated new protections against providers "steering" patients into agreeing to withdraw or withhold life-sustaining treatment; among other modifications. OCR closed the complaint with no finding of liability. "I'm grateful to the Utah doctors, hospital leaders, medical ethicists, and others who helped us develop important standards for caring for people in a crisis. I don't anticipate having to use these standards, but it's important to be prepared, especially so we can care for those who are most vulnerable when resources are limited," said Utah Governor Gary Herbert.

Food and Drug Administration (FDA)

August 15—FDA issued an emergency use authorization to Yale School of Public Health for its SalivaDirect COVID-19 diagnostic test, which the agency said is unique because it does not require any special type of swab or collection device--the saliva sample can be collected in any sterile container. In addition, the test does not require a separate nucleic acid extraction step. According to FDA, Yale intends to provide the SalivaDirect protocol to interested laboratories as an “open source” protocol. Designated laboratories could follow the protocol to obtain the required components and perform the test in their lab according to Yale’s instructions for use. “Providing this type of flexibility for processing saliva samples to test for COVID-19 infection is groundbreaking in terms of efficiency and avoiding shortages of crucial test components like reagents,” said FDA Commissioner Stephen M. Hahn, M.D. “Today’s authorization is another example of the FDA working with test developers to bring the most innovative technology to market in an effort to ensure access to testing for all people in America."

Centers for Disease Control and Prevention

August 19—CDC released a new study underscoring COVID-19’s disproportionate impact on American Indians and Alaska Natives (AI/AN). Based on data from 23 selected states, laboratory-confirmed COVID-19 cases among AI/AN was 3.5 times that of non-Hispanic Whites. The study also found that AI/AN who tested positive for the coronavirus tended to be younger than White non-Hispanic individuals with COVID-19. CDC noted that recent studies have indicated AI/AN are among the racial and ethnic minority groups at higher risk for severe COVID-19 outcomes, the agency said. CDC said it has provided more than $200 million in COVID-19 funding to support tribes and tribal organizations in combatting the virus. “American Indian and Alaska Native people have suffered a disproportionate burden of COVID-19 illness during the pandemic,” said CDC Director Robert R. Redfield, M.D. “This funding approach will broaden access to COVID-19 resources across tribal communities.”

Other Developments

August 19—Senators Elizabeth Warren (D-MA), Chris Murphy (D-CT), and Tina Smith (D-MN) urged HHS and the CDC to coordinate with state officials to develop national reporting standards of COVID-19 cases linked to colleges and universities. The lawmakers noted in a letter to the agencies that there currently is no national method for reporting and tracking COVID-19 cases at these institutions. "Furthermore, HHS, CDC, and state and local public health departments should work together to collect demographic data in a standardized format from institutions of higher education in order to monitor any disparities among affected students and staff," the letter said. The lawmakers asked the agencies for a response by September 2. 

August 19—The American Hospital Association (AHA) sent a letter to President Trump urging his administration to further expand telehealth flexibilities. "Patients have been empowered by this flexibility to seek and receive virtual care at all of the places they can currently access in-person care, including hospital outpatient departments," the letter said. AHA said the administration should work with lawmakers "to create a future for telehealth that allows not only clinicians, but also hospitals and health systems, to code and bill for virtual services."