This story was originally published Aug. 17, 2020, in 360Dx sister publication Modern Healthcare and was written by Rachel Cohrs.
NEW YORK – Insurers may have found a loophole in Congress' COVID-19 diagnostic testing coverage requirements: pooled test results.
Trump administration officials have hailed pooling COVID-19 testing samples as a way to increase testing capacity while conserving supplies, but at least one insurer tried to exempt themselves from paying for any sort of pooled testing under a standard set in guidance from the Trump administration.
Pooled COVID-19 testing is most effective in situations where most of the samples are expected to be negative, including in widespread screening of asymptomatic individuals. The US Food and Drug Administration has given Quest Diagnostics, Laboratory Corporation of America, the University of California San Diego Health, and Poplar Healthcare emergency authorization to conduct pooled COVID-19 testing. On July 28, FDA released guidance stating that "FDA believes that sample pooling can be safely implemented for use in certain diagnostic and screening tests."
The Trump administration on June 23 issued guidance clarifying that insurers don't have to pay for tests that are used for public health surveillance or workplace safety purposes. One of the potential uses for pooled testing is to drive down testing costs for employers bringing back workers.
Cigna referenced the guidance's language to say it wouldn't cover any pooled COVID-19 testing in a coverage policy that went into effect on Aug. 1.
"Molecular in vitro diagnostic testing using pooled samples is not covered as this is considered screening," the policy said.
A Cigna spokesperson said Friday that the insurer is planning to change the policy and plans to cover pooled testing in the same way as individual testing.
The American Clinical Lab Association criticized the Cigna policy.
"There's a disconnect here. Pooling is a technique encouraged by the federal government and public health experts to expand access to testing, but this particular policy refuses to cover it," ACLA President Julie Khani said.
Providers argue that pooled tests may be used for diagnostic purposes as well as public health surveillance.
Heather Pierce, senior director of science policy and regulatory counsel at the Association of American Medical Colleges, said the distinctions between diagnostic, screening and surveillance testing are less clear than one might imagine.
"Pooled testing is still testing for COVID-19, and the fact that specimens are pooled does not tell you what it's being used for," Pierce said.
Molly Smith, vice president of coverage and state issues at the American Hospital Association, said the group is not aware of any hospitals or health systems using pooled testing, but is increasingly hearing reports of insurers deeming COVID-19 tests not medically necessary and refusing to pay for them.
"Pooled testing can absolutely be used for medically necessary diagnostic purposes," Smith said in a written statement.
The American Medical Association said it is assessing the emerging issue of coverage of pooled coronavirus tests and is assessing possible next steps.
Democratic leadership of the House Energy & Commerce Committee announced an investigation into several insurers' practices and policies amid the COVID-19 pandemic, given that insurers reported enormous profits in the second quarter of 2020. Democrats sent Anthem, Cigna, CVS Health, Humana, and UnitedHealth Group letters asking for information including complete descriptions of the insurance companies' COVID-19 testing coverage policies and practices and records of all complaints from customers related to coronavirus testing.
"We're going to get to the bottom of this and ensure that consumer protections are upheld," Energy & Commerce Chair Frank Pallone (D-New Jersey) said.
When asked about coverage of pooled testing, a Humana spokesperson said the insurer is covering all COVID-19 diagnostic testing with no cost-sharing. An Anthem spokesperson said the company covers medically necessary COVID-19 testing.
Insurers and labs have asked Congress to create a national testing fund to pay for tests insurers aren't required to pay, but lawmakers haven't advanced a similar policy. They also have said that without more federal funding, patients will have less access to testing and providers could face payment disruptions.
"Expanded access to COVID-19 testing for all individuals, regardless of their coverage status or purpose for receiving the test (i.e. diagnostic, public health or return-to-office), will require additional dedicated and robust federal funding," groups including America's Health Insurance Plans, ACLA, Blue Cross Blue Shield Association, and the US Chamber of Commerce wrote to congressional leaders.
Meanwhile, negotiations on another COVID-19 relief package have stalled and are unlikely to revive until Congress approaches a government funding deadline at the end of September.