CMS and CDC “Tag Team” on Point-of-Care Testing

The Centers for Medicare and Medicaid Services (“CMS”) earlier this month issued a series of frequently asked questions (“FAQs”) regarding the point-of-care (“POC”) program to provide certain Medicare and Medicaid certified nursing homes with equipment and supplies to perform COVID-19 antigen testing (the “Program”).  The Centers for Disease Control and Prevention (“CDC”) later followed up with updated interim guidance that provides context for some of CMS’s statements in the FAQs and additional details regarding collection and handling of specimens, performance of antigen testing, and evaluating test results, but whether the tag team effort is enough to satisfy calls from providers for detailed guidance remains to be seen.

Program Basics, Timeline and Prioritization

Under the Program, eligible nursing homes will receive from one of two manufacturers at least one antigen testing instrument and test kits sufficient to perform one baseline test for all residents and staff.  The devices and test kits began shipping to more than 3,900 facilities during the week of July 20^th and will continue to ship for approximately 14 weeks.  Shipments have been prioritized for eligible facilities in COVID-19 hotspots identified by the CDC and those facilities reporting data that indicates an elevated risk for COVID-19 transmission.  Specifically, facilities have been prioritized if they reported to the CDC’s National Health Safety Network (“NHSN”) by July 5^th any of the following during the previous seven (7) days:

• Three (3) or more confirmed or suspected new cases of COVID-19
• At least one (1) new COVID-19 case after having no previous COVID-19 cases
• Inadequate access to testing
• At least one (1) new resident death due to COVID-19
• At least one (1) new confirmed or suspected COVID-19 case among staff

In order to participate in the Program, facilities must (a) be Medicare and/or Medicaid-certified, (b) have a current Clinical Laboratory Improvement Amendments of 1988 (“CLIA”) Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation, and (c) meet the epidemiological criteria for prioritization outlined above.  Following the initial shipment based on epidemiological data reported by July 5^th, the Department of Health and Human Services (“HHS”) will continue a phased distribution of instruments and test kits to qualified facilities based on updated epidemiological data reported by facilities.

Collection and Handling of Clinical Specimens

The CDC guidance stressed maintaining the integrity of the specimen by using proper collection techniques, adequate quality assurance procedures to avoid cross-contamination, and minimizing delays between specimen collection and testing.  While the CDC guidance also mentioned but did not elaborate on the use of biosafety measures in the collection process, the CMS FAQ provided a summary of those measures, which include maintaining proper infection control and use of Personal Protective Equipment (“PPE”), conducting a site-specific and activity-specific risk assessment to identify and address safety risks, training for staff, and decontamination of the testing instrument after each test run, among other measures.

Evaluation of Test Results

CMS stated that antigen testing is not as sensitive as molecular testing.  This statement is buttressed by the CDC guidance, which states that the antigen tests that have received Emergency Use Authorization (“EUA”) from the Food and Drug Administration (“FDA”) have demonstrated a sensitivity—how often the test correctly generates a positive result for people with the SARS-CoV-2 virus–of 84% and 97%.  By contrast, the antigen tests demonstrate a 100% rate of specificity—the ability of the test to correctly generate a negative result for people who don’t have the SARS-CoV-2 virus.  Thus, while false positives are unlikely, the antigen tests can yield false negatives.  Consequently, both CDC and CMS state that a negative POC test generally should be treated as presumptive by the facility but should be “considered in the context of a patient’s recent exposures, history and the presence of clinical signs and symptoms consistent with COVID-19.”  Accordingly, both agencies recommend confirming a negative POC antigen test with a more accurate molecular test, particularly if the patient is symptomatic or has a known exposure to a person confirmed to have COVID-19.  The CDC further recommends that the confirmatory molecular test be performed within two (2) days of the initial antigen test.  While the CMS FAQs state that a confirmatory molecular test is not necessary in the event of a positive antigen test, the CDC guidance recommends a confirmatory test under certain circumstances when the antigen testing is done for screening purposes as is the case with baseline testing of all residents and staff of a nursing facility.

Reporting 

The results of all POC tests must be reported in accordance with Coronavirus Aid, Relief, and Economic Security (“CARES”) Act reporting guidance.  That guidance states that all results must be reported to state or local public health departments on a daily basis and within 24 hours of the results being known or determined.  Additionally, facilities must comply with CMS mandates for reporting COVID-19 cases among residents and staff to the National Health Care Safety Network.

Other

Other items of note addressed in the FAQs:

• As noted above, facilities will be supplied with test kits sufficient to conduct one baseline test of all residents and staff. Thereafter, each facility must purchase test kits from the manufacturer or a medical device distributor if it wants to continue conducting POC testing.
• Testing must be ordered by a licensed healthcare professional or pharmacist.
• Facilities should follow Centers for Disease Control and Prevention (“CDC”) safety guidelines for handling and processing laboratory specimens unless the State Agency has more stringent requirements.

While the FAQs and CDC guidance certainly address some of the more pressing issues for nursing homes, they did so only in very generalized terms.  As with any program that involves nursing home operations, reporting and reimbursement considerations, the devil is always in the details.  As instruments and testing supplies continue to be distributed, providers are clamoring for detailed guidance from CMS, particularly with respect to reporting.  Whether such guidance will be forthcoming, however, remains to be seen.