Thursday, July 16, 2020

Summary of CMS Call on Point-of-Care COVID-19 Testing for Nursing Homes

On July 14, Centers for Medicare and Medicaid (CMS) announced an initiative to distribute of point-of-care COVID-19 testing devices to nursing homes across the country. Seema Verma, Administrator of CMS and Admiral Giroir, MD, Assistant Secretary for Health at the U.S. Department of Health and Human Services (HHS) held a nationwide conference call with nursing homes on July 15 to provide additional information about the rollout.  

Nursing facilities will receive one of two testing devices: 
These testing devices are able to run 15-20 tests per hour and the results are available within 15 minutes, according to the companies’ websites. These devices are already commonly used in doctors’ offices to diagnose flu or strep throat.

Both tests are antigen tests, which are different from the traditional PCR or molecular test. Antigen tests detect the presence of viral proteins in a biological sample, such as a tissue swabbed from the nasal cavity. Both antigen and PCR tests directly diagnose for COVID-19. The disadvantage of an antigen test is that it has lower sensitivity than a PCR test. The sensitivity for an antigen test is generally between 80-90%, lower than 95-98% for a PCR, which means the likelihood of a false negative with an antigen test is higher than with a PCR test. (Note: sensitivity means the % of people who actually have the disease who test positive [true positives]; therefore 1-sensitivity equals the false negative rate; so a test with 85% sensitivity detects the disease 85% of the time and misses it 15% of the time). Administrator Verma and Dr. Giroir addressed this during the call on Wednesday, saying if you have to wait over 48 hours for a lab test result, use of testing may not be as helpful controlling spread of the virus and as such, the extra sensitivity of a PCR test may not be as beneficial.

CMS is distributing the initial set of devices to nursing facilities in hotspot areas, such as Florida, Texas and Arizona. They will use the NHSN data to determine facilities in hotspot areas who have three or more cases and low hospital capacity, and then further prioritize that list as necessary. They hope to have between 1,500-2,000 testing devices delivered to the hardest hit nursing homes by the end of next week. Then they will work to deliver devices to all nursing homes in the country over the next 2-3 months.

The devices will come with a limited number of test kits, and nursing homes will have to reorder more test kits from the manufacturer once they run out. The costs for test kits were estimated at less than $25 per test. CMS and HHS recognizes that providers will have many questions, but they did not want to delay in getting this program started and will be providing more guidance in the coming weeks.

CMS intends these testing devices to be utilized for both screening and diagnostic purposes.

In her comments, Administrator Verma explained that distribution of these testing devices came as direct result of feedback she has received from AHCA/NCAL and providers across the country on difficulty in accessing testing and slow turnaround times. She expressed support for the industry and a willingness to work with providers to focus on solutions.

Administrator Verma also announced new resources available through the Quality Improvement Organizations (QIO’s). QIO’s will be conducting trainings and providing direct assistance to nursing homes in hotspots across the country at no cost. She also announced a national training coming in early August and promised more details in coming days.  

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