Burgess Hill, West Sussex – 12 January, 2021 Covid-19 home PCR self-test kit.

Pandemic Diagnostics: Present and Future Implications of Self-Testing Reimbursement

By David A. Simon

The process of diagnosing a disease or condition, including detection of SARS-CoV-2 infection, is changing.

Consumers now can not only collect their specimen from their living room couch, but they can test it while watching Netflix. Sampling, testing, and obtaining results all can be done in a patient’s home.

For communicable diseases like COVID-19, the disease caused by SARS-CoV-2 infection, at-home testing has considerable public health benefits. In addition to being more convenient than traditional diagnostics, self-testing can substantially reduce or eliminate the risk that infected individuals will spread the virus en route to a testing site.

This innovation has been spurred, in part, by a powerful incentive: the federal government has all-but guaranteed reimbursement for these tests.

Congress achieved this objective in 2020 by passing The Families First Coronavirus Response Act (FFRCA). The statute mandated that all public, and almost all private, health insurance plans, cover testing for “the detection of SARS-CoV-2 or diagnosis of the virus that causes COVID-19” at no cost to the policyholder.

But there’s a catch. Insurance plans are required to cover these tests only “when medically appropriate for the individual, as determined by the individual’s attending healthcare provider.”

For many diagnostic tests, including those for COVID-19, this seems like a rather ordinary requirement. In the normal course of events, a patient visits a physician, who then orders a test, which a lab fills, and which insurance pays for. This is how bloodwork is usually ordered, for example, to screen for cholesterol and inflammatory conditions.

But not everyone has access to a health care provider needed to perform an “individualized clinical assessment.”

While the Centers for Medicare and Medicaid Services (CMS) issued a federal waiver for telehealth services, which allowed reimbursement of physicians for “virtual” care — including initial consults designed to make an “individualized clinical assessment” to determine whether testing is appropriate — this does not fully address issues of access. Some individuals don’t have a physician (e.g., none in neighborhood, no insurance) or the technology or capacity needed to access one (e.g., smartphone, broadband, transportation, lack of childcare, lack of mobility)—that they can see, either in person or remotely.

Or it may not be feasible to see a physician before a test is needed — say, in time for work or school the following day. The federal government realized this could be a problem. And before any self-testing option — indeed, before widespread testing was available — the CMS tried to address this challenge by compensating firms for travel and personnel costs of specimen collection for home-bound patients.

The question remains: when patients with need, but without access, to health care services have to purchase tests for themselves and collect specimens or perform them alone in their living room, will they be reimbursed?

While plans can choose to cover COVID-19 testing without a health care provider’s order, they are not required to do so. (A recent executive order and subsequent new guidance clarifying that plans and issuers can’t impose “medical management, including specific medical screening criteria, on coverage of COVID-19 diagnostic testing” left this requirement unchanged.)

And because insurance companies issue plans and make coverage determinations state by state, and because there are many different plans in each state, it’s difficult to know how many, if any, insurers or plans are reimbursing patients for them.

Companies that offer these tests — either directly or at retail outlets — generally don’t promise reimbursement. CVS informs interested patrons that over-the-counter COVID-19 diagnostic tests are “not covered by insurance” at all. Some dangle it as a possibility: Companies that offer self-testing kits, like Everlywell, advertise that the test “may be reimbursed if you have health insurance.” Pixel, on the other hand, will offer the test at “no upfront cost” (and bill insurance) for those that meet “clinical guidelines for COVID-19 testing” (though the patient would still be responsible for payment if insurance denies coverage). For everyone else, however, immediate payment is required.

Thus, despite ample government incentives, at-home COVID-19 testing illustrates how even the most well-financed efforts can miss opportunities to ensure equity and expand access to the home health revolution. If this is the result when unprecedented funding is available, what should we expect for other types of diagnostic testing outside the clinic, where funding is more limited? What will happen, for example, when Medicare — which provides benefits to nearly 100 million beneficiaries — doesn’t reimburse for a diagnostic test? Will private capital support retail diagnostics, especially when the diagnosis the test can provide is for a small subset of the population?

Although private funding of certain technologies has already begun to adjust, it remains an open question whether, how, and when, at-home diagnostic testing will too, despite the benefits to patients and public health we’ve seen during the COVID-19 pandemic.

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