Dive Brief:
- The Centers for Medicare and Medicaid Services on Wednesday said it raised the Medicare reimbursement rate for high-throughput coronavirus molecular tests from about $51 to $100.
- CMS Administrator Seema Verma said the agency nearly doubled what it pays for the clinical diagnostic lab testing that leverages high-throughput technologies because the platforms are able to "process a large volume of COVID-19 tests rapidly and accurately.” The new payment policy is effective April 14.
- The American Clinical Laboratory Association, whose members include LabCorp and Quest, praised the action by CMS for helping to support labs responding to the COVID-19 pandemic. ACLA said it hopes other payers will follow the agency's example and raise their reimbursement rates.
Dive Insight:
Commercial labs like LabCorp and Quest are leveraging high-throughput testing platforms seen by the Trump administration and ACLA as critical to expanding the nation's testing capacity. CMS noted the tests can process more than 200 specimens a day and require specialized personnel.
The move comes as ACLA has for weeks sounded an alarm to the administration about the financial strain on commercial labs from uncompensated COVID-19 testing services as well as increasing costs for test supplies including swabs, reagents, and personal protective equipment. In particular, the group has looked for assurances that its members will be fairly reimbursed for the tests they are performing.
"The lack of predictable reimbursement for tests performed has been a barrier to entry for some laboratories, and today’s decision will help encourage all laboratories with the appropriate expertise to come to the table and perform COVID-19 testing," said ACLA President Julie Khani in a written statement Wednesday.
CMS in particular called out the hiked payment as helping stem the spread in nursing homes, where the virus has proved especially deadly.
Roche was the first commercial test developer to receive the FDA's emergency use authorization. The company's SARS-CoV-2 test runs on Roche's cobas 6800/8800 high-throughput molecular testing systems.
A Roche spokesman told MedTech Dive it continues to ramp up production to meet the growing demand and has exceeded its commitment to ship volumes of 400,000 tests per week to labs across the country since the Swiss giant announced an FDA nod last month for its test.
Vice President Mike Pence warned in Monday's White House briefing that 20% of the capacity of the "Roche equipment that is out there that does the high-speed testing" is "not being used." Pence added that 75% of the laboratory capacity of Abbott high-throughput systems "that exist in the United States today are not being utilized."
Roche demurred in responding, pointing to the labs themselves.
"It wouldn't be appropriate for us to speak on behalf of individual laboratories, as they determine how to deploy their Roche instruments for testing," a company spokesman told MedTech Dive. "However, if there is unused capacity for running Roche's cobas SARS-CoV-2 test, it may be related to the COVID-19 testing situation in general, that demand for tests is still outpacing supply."
Abbott was not immediately available for comment.
However, last week, White House coronavirus response coordinator Deborah Birx said more than 90% of the 1 million Abbott coronavirus tests delivered to laboratories across the country have not been used because labs don’t have the resources to operate the company’s high-throughput systems.
“They're not running,” Birx said. “We've only run 88,000 tests in three weeks off of those machines, with a million test kits.”
Abbott argued its systems are not the problem. “They are running, labs just need to expand volumes” by increasing staff and supplies, a spokesperson said in comments to MedTech Dive. However, labs nationwide are facing staffing issues and supply shortages hampering their abilities to perform the tests.
