Opening Up America Again: CMS Issues Guidance on Re-Opening Facilities for Non-COVID-19 Care; FDA Facilitating Quicker Development of Diagnostic Testing
On March 18, the Centers for Medicare & Medicaid Services (CMS) recommended health care providers limit non-essential care in order to expand surge capacity for COVID-19 patients, conserve staff and supplies of personal protective equipment (PPE) and to slow the spread of the coronavirus. State health authorities across the United States issued similar guidelines limiting non-essential care.
On April 19, CMS posted Phase 1 Recommendations for Re-opening Facilities to Provide Non-emergent, Non-COVID Care (CMS Phase 1 Guidelines), available here. In this context, Phase 1 refers to the initial phase of the National Guidelines for Opening Up America Again (National Guidelines), available here, announced on April 16.
Under the National Guidelines, those states or regions that satisfy “gating criteria” may proceed to Phase 1 reopening activities, including the resumption of elective surgeries “as clinically appropriate, on an outpatient basis at facilities that adhere to CMS guidelines.” Balanced against measures to slow the spreading pandemic, CMS acknowledges the importance of restarting care that is currently being deferred, such as certain procedural care (surgeries and procedures), chronic disease care and preventive care.
Consistent with Phase 1 of the National Guidelines, the CMS Phase 1 Guidelines are intended to give health facilities flexibility in providing essential, non-COVID-19 care to patients without symptoms of COVID-19 in regions with low incidence of COVID-19. CMS generally recommends that providers:
- Coordinate the restart of in-person care with local and state health officials to properly evaluate the incidence and trends in COVID-19 for the area;
- Prioritize surgical/procedural care and high-complexity chronic disease management, recognizing that select preventive services may be necessary;
- Consider establishing Non-COVID Care (NCC) zones that would screen all patients for symptoms of COVID-19, including temperature checks. Staff would be routinely screened as would others who work in the facility including physicians, nurses, housekeeping, delivery and all people who would enter the area;
- Assure, without jeopardizing COVID-19 surge capacity, that sufficient resources are available at the facility across phases of care, including Personal Protective Equipment (PPE), healthy workforce, facilities, supplies, testing capacity and post-acute care.
Regarding these resource categories, CMS provides a number of specific recommendations.
Upon reopening, providers and staff should follow CDC recommendations by wearing surgical face masks at all times. Importantly, procedures on the mucous membranes (including the respiratory tract) with a higher risk of aerosol transmission should be done with great caution, and staff should utilize appropriate respiratory protection such as N95 masks and face shields. For patients, a cloth face covering that can either be bought or made at home should be used unless surgical masks are available to the patient. The facility also should make efforts to conserve PPE so as to not diminish surge capacity.
Facility considerations include creation of NCC zones that follow guidelines to reduce risk of COVID-19 exposure and transmission:
- Ideally, NCC zones should be separated from other facilities, either in a separate building, in designated rooms, or on a floor with a separate entrance and minimal crossover with COVID-19 areas.
- Facility guidelines should promote social distancing, such as little or no time in waiting areas, spacing chairs at least 6 feet apart and maintaining low patient volumes.
- Visitors generally should be prohibited. If a visitor is necessary for an aspect of patient care, visitors should be pre-screened in the same manner as patients.
In the CMS Phase 1 Guidelines, CMS mentions testing capacity as a threshold requirement for health facilities to begin reopening. In particular, CMS suggests that:
- All patients must be screened for potential symptoms of COVID-19 prior to entering the facility, and staff must be routinely screened for potential symptoms; and
- When adequate testing capability is established, patients should be screened by laboratory testing before care, and staff working in these facilities should also be regularly screened by laboratory test.
Clearly, the wide availability of reliable and timely testing will be critical to the ability of health care facilities across the country to begin reopening. On February 29, 2020, the United States Food & Drug Administration (FDA) issued guidance for clinical laboratories, commercial manufacturers and FDA staff establishing a policy to accelerate the availability of COVID-19 diagnostic tests. The FDA subsequently updated this guidance on March 16.
In the initial guidance, the FDA identified two pathways for increasing the developmental pace of laboratory tests for COVID-19—one where the manufacturer submits the test to the FDA for an Emergency Use Authorization (EUA), and the other where the manufacturer does not seek an EUA. In the updated March 16 guidance, the FDA extended the policy to cover diagnostic tests developed by commercial manufacturers. Still, the FDA identified two pathways for the development and deployment of such tests: one where an EUA is sought and one where it is not.
While the non-EUA pathway for manufacturers facilitates development of new tests, the FDA makes it clear in their FAQs on Diagnostic Testing that any test utilizing this pathway will be deemed high complexity by default. By contrast, the FDA clarified that point-of-care tests that have received an EUA may be performed in a patient care setting operating under a CLIA certificate of waiver.
Practically, the FDA’s position means that only point-of-care tests that have received an EUA may be used at physician office, dental office or surgery center location. Even for point-of-care tests authorized under an EUA, the FDA recommends that test reports include a general statement that the test has been validated, but that the FDA’s independent review of the validation is pending. For tests developed and distributed without an EUA, the FDA recommends that even more extensive disclaimer language accompany the test reports.
Healthcare providers should be cognizant of the limitations of serological/antibody testing (as contrasted with the more accurate molecular tests). In a letter to providers, the FDA recommends the continued use of serological tests intended to detect antibodies to SARS-CoV-2 to help identify people who may have been exposed to the SARS-CoV-2 virus or have recovered from the COVID-19 infection. However, the FDA cautions that users should be aware of the limitations of the antibody tests. In particular, the FDA stresses that providers should not use serological tests as the sole basis to diagnose COVID-19, instead, the FDA indicates that these tests should be used only to determine whether a person may have been exposed to the virus. Further, the FDA notes that negative serological test results do not rule out SARS-CoV-2 infection, particularly in those who have been in contact with the virus, and that “follow-up testing with a molecular diagnostic should be considered to rule out infection in those individuals.”
In an acknowledgement that even the expanded pathways may be insufficient to address the current need for tests, on April 18 the FDA issued a statement declaring that the FDA is collaborating with the National Institutes of Health’s National Cancer Institute, National Institute of Allergy and Infectious Diseases, and the Centers for Disease Control and Prevention to establish a capability at the National Institutes of Health to evaluate serological tests for developers, including tests already available for use, as well as tests not yet on the market where additional validation data is needed to support an EUA. In the statement, the FDA reiterated that all clinical tests need to be validated prior to use. Also, to minimize the number of false positive results, serological tests in particular must be well-designed to specifically identify antibodies against COVID-19 and must not “cross-react” or provide positive results when encountering antibodies against other respiratory viruses.
In planning for reopening of offices and facilities, we recommend that providers (1) carefully review the FDA authorization status of any test they are considering, (2) ensure that the tests are used only in the settings authorized under FDA guidance and any applicable EUA, (3) make certain that the type of test used is appropriate for the screening for which it is being used and (4) ensure the test results are reported with any appropriate disclaimer language recommended by the FDA.
Those clients and providers who have questions or comments regarding this bulletin should contact the Taft attorney with whom they regularly work or a member of Taft’s Health Care and Life Sciences Group.
Please visit our COVID-19 Toolkit for all of Taft’s updates on the coronavirus.
In This Article
You May Also Like
In Bittner v. United States, Supreme Court Delivers Non-Willful FBAR Penalty Relief Key Takeaways from the American Bar Association’s 38th Annual National Institute on White Collar Crime