Earlier this week we reported that the Centers for Medicare and Medicaid Services (CMS) authorized the distribution of rapid point-of-care diagnostic test instruments and test kits to all nursing homes in the country. The tests that will be distributed are protein antigen tests that can quickly detect fragments of proteins found on or in the virus by testing samples collected from the nasal cavity using swabs. Results can be provided in minutes.
The initial distribution of these testing instruments and test kits to approximately 2,000 skilled nursing facilities will begin next week. This initial distribution will focus on facilities in critical geographic hotspots around the country. The distribution of the remaining testing instruments to approximately 13,000 additional skilled nursing facilities should be completed within six to eight weeks. The distribution is anticipated to be messy and chaotic. Currently there are many questions, but few answers.
Providers will receive a limited number of test kits (approximately 400). When these test kits are depleted, providers will need to purchase additional tests from the manufacturer. Cost is anticipated to be about $25 per test, with the possibility of additional discounts. There are many unanswered questions regarding the billing of Medicare and Medicaid for the costs of these test kits. As these answers become available, we will let you know.
According to CMS, the tests and the test instruments are approved and authorized for use by laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), which meet the requirements to perform waived, moderate, or high complexity tests. CMS has explicitly stated that these tests are authorized for use at the point of care, e.g., a patient care setting such as a skilled nursing facility operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accommodation.
It is important to note that Washington labs do not operate under CLIA Certificates of Waiver. In Washington State, our testing labs operate under state “Medical Test Site” licensing. The Washington Medical Test Site licensing program is exempt from CLIA. In Washington, Medical Test Sites do not apply separately to CMS for a CLIA number. Instead, the Washington Department of Health interfaces with CMS to obtain a CLIA number for the applicant. The Medical Test Site license will contain the MTS license number and a CLIA number.
Therefore, in Washington State Medical Test Sites are not technically operating under a CLIA waiver. This technicality will likely hinder the CMS plan to distribute testing instruments in skilled nursing facilities throughout the state.
In addition, it is also our understanding that Washington’s unique regulatory model could further hinder widespread distribution of the test instruments due to the fact that each Medical Test Site may need to apply for, and receive, specific approval from the Department of Health (DOH) before they can conduct COVID-19 testing. We are seeking clarification from DOH about this and other issues.
WHCA is focused on this issue. We have already been in touch with leadership at DOH and the Department of Social and Health Services (DSHS), and we have been informed that they are attempting to resolve these issues with CMS. As always, we will keep you informed as this issue develops.
Special thanks to Bill Ulrich of Consolidated Billing Services Inc. and Elena Madrid of WHCA for their help with this issue.
