AACC and five other laboratory groups wrote to Vice President Mike Pence asking that the White House Coronavirus Task Force provide transparency into the allocation and availability of laboratory supplies needed to respond to COVID-19. “Our organizations stand ready and willing to partner on any efforts to facilitate the release and dissemination of this information,” the letter says. A lack of transparency into the federal government’s acquisition and distribution of testing supplies to states and private laboratories is compounding the problem of insufficient reagents, personal protective equipment, and other supplies, according to the letter.

The organizations urge the White House Coronavirus Task Force to lead a coordinated federal effort to transparently communicate information on the availability of SARS-CoV-2 testing supplies and to do everything possible to encourage the production of sufficient testing supplies. Relying on one test platform or two or three large manufacturers isn’t enough to increase testing capacity, the letter notes.

“We urge the Task Force to take bold action to encourage the manufacturing of COVID-19 test supplies and to transparently share information on the availability of supplies among the entire laboratory community,” the letter adds. “Until the federal government takes action, these shortages will persist, future surges in the pandemic will occur, and patients will continue to suffer.”

In a separate letter to leaders of Congress, AACC revealed new evidence of continuing supply shortages in laboratories. AACC’s most recent survey, completed in September, found that 68% of labs had trouble obtaining test kits, up from 48% of respondent laboratories in May. The same percentage of laboratories also had trouble getting reagents. The survey did show improvement in the ability to obtain swabs: 36% of laboratories reported this problem, versus 62% in May.

CMS Pegs Payments to Speed for SARS-CoV-2 Testing

After nearly doubling payment for high-throughput SARS-CoV-2 tests from about $51 per test to $100 per test in April, the Centers for Medicare and Medicaid Services (CMS) beginning January 1 is cutting those rates back to $75 for clinical laboratories that do not turn around results within 2 days. Medicare will pay $100 only to laboratories that complete high throughput tests within 2 calendar days of the specimen being collected.

The plan works by cutting the high-throughput SARS-CoV-2 diagnostic test reimbursement rate to $75. To get a $25 add-on payment that will bring the total back up to $100, laboratories would have to do two things: complete the test in 2 calendar days or less and complete the majority of their SARS-CoV-2 tests in 2 calendar days or less for all of their patients (not just their Medicare patients) in the previous month. CMS is implementing the change under an amended administrative ruling (CMS-2020-1-R2) and coding instructions for the $25 add-on payment (HCPCS code U0005).

Laboratory groups are speaking up against the payment change. Most experts see supply shortages and other constraints as the cause of slow turnaround times, not a lack of financial incentive.

Government Cracks Down on CLIA Rules Related to COVID-19

The Centers for Medicare and Medicaid Services (CMS) is focusing on making sure that clinical laboratories’ CLIA certifications are up to date. After a recent record check, CMS issued 171 cease and desist letters since August 2020 to facilities that did not have proper CLIA certifications in place.

In a statement, CMS underscored that any facility that conducts SARS-CoV-2 testing is considered a laboratory and must be certified under CLIA. To make certification more efficient, CMS implemented an expedited review process at the beginning of the public health emergency and recently released a quick start guide that helps laboratories with the application process.

According to the agency, of the 171 cease and desist letters issued, 34% went to facilities conducting laboratory testing without a CLIA certificate and 66% were issued to laboratories performing SARS-CoV-2 testing outside the scope of their existing CLIA certification.