With the increased demand for monkeypox testing, clinical labs will need to be aware of the regulations surrounding coding, reimbursement issues, and compliance issues.
By Ann H. Carlson
As monkeypox testing expands across the country, CLP asked Joyce Gresko, JD, partner in Alston & Bird’s Health Care Group, Washington, DC, to explain the regulatory implications for laboratories that are onboarding monkeypox diagnostics.
Answers have been edited for length and clarity.
CLP: How are diagnostic labs responding to monkeypox and increased testing demand? What growth do you expect to see in testing options and availability?
Joyce Gresko: Many laboratories have the instruments and expertise required to run high-throughput PCR tests on monkeypox test specimens, and they have been putting these assets to good use. While demand has grown, it still is less than the available capacity, although this may change, depending on the trajectory of the spread of infections. Specimen collection for monkeypox testing typically involves swabbing one or more lesions, and this limits the circumstances and locations in which samples can be collected. To broaden the availability of testing, laboratories are working on developing tests that use alternate specimen types (e.g., saliva samples). Home specimen collection also is on the horizon. Unlike a respiratory virus like COVID-19, where self-collection entails a swab around the nose, monkeypox testing entails swabbing a lesion, which can be painful. It will be important to build controls into home specimen collection to ensure that the samples are adequate for testing.
CLP: What new coding, coverage, and payment issues should diagnostic labs that offer monkeypox testing be aware of?
Gresko: In late July 2022, the American Medical Association Current Procedural Terminology (CPT) editorial panel approved an application for a CPT code 87593 to report monkeypox testing services. The code descriptor is: “Infectious agent detection by nucleic acid (DNA or RNA); orthopoxvirus (e.g., monkeypox virus, cowpox virus, vaccinia virus), amplified probe technique, each.” Even with a public health emergency having been declared by Xavier Becerra, secretary of the Department of Health and Human Services, on Aug. 4, 2022, Medicare Administrative Contractors (MACs) are approaching coverage and payment much the same way that they would for any other clinical laboratory test. Each of the MACs have priced the new code using crosswalking, with reimbursement ranging from $35.09 to $51.31, and coverage will be determined according to the same “reasonable and medically necessary” criteria used for other Medicare services. Commercial payors similarly are covering and paying for monkeypox testing in the same way as for other new tests.
CLP: What are the new regulatory compliance considerations labs should keep in mind when testing for monkeypox?
Gresko: On Sept. 7, 2022, the Food and Drug Administration (FDA) declared that circumstances exist to justify the authorization of emergency use of in vitro diagnostics for detection and diagnosis of monkeypox virus. Practically speaking, this means that many diagnostic tests will need emergency use authorization (EUA) to be offered going forward. The policies articulated in the guidance document that accompanied the FDA declaration are notable in a number of ways.
First, for a laboratory developed test (LDT) that is a PCR test developed and used in a single CLIA-certified high-complexity laboratory, and that uses patient samples collected with lesion swabs, the FDA will require only that the laboratory notify it within five business days of offering the test (or within five days of the issuance of the guidance for LDTs already on the market), and it will not require that the lab seek an EUA for the test. Further, in many cases, an FDA-authorized test that has been modified by a CLIA-certified high-complexity laboratory will not need an EUA to be marketed. However, a test that is developed in one laboratory and used in multiple laboratories will need to have an EUA, as will a test with home specimen collection.
Also, the FDA is limiting its “no EUA required” policy to PCR tests that test lesion swab specimens, because it is confident that appropriately validated tests can detect the monkeypox DNA from lesion swabs. Per the FDA, this policy is due to the “urgent need to continue to expand the nation’s capacity for monkeypox testing at this stage of the public health emergency.” The FDA may characterize this policy as an extension of the long-standing “enforcement discretion” it has exercised with respect to LDTs, but it is a departure from the agency’s stumble out of the gate in the earliest days of the COVID-19 pandemic, when laboratories only had a faulty CDC test to use and could not develop and offer their own tests when they were most needed.
Second, the FDA intends to prioritize review of EUA requests for high-throughput diagnostic tests, tests with home specimen collection, and rapid tests from “experienced developers” that inform the FDA within 30 days of the issuance of the guidance of intent to submit an EUA request. This prioritization of EUA requests is similar to the policy the FDA announced in late 2021 for EUA request for COVID-19 testing, where it focused on request from labs that could process many specimens each day and an EUA request for at-home and point-of-care tests.
CLP: The emergence of monkeypox has led to much discussion of the stigma associated with STI testing. How can labs help counteract this stigma?
Gresko: Labs can do their part to counteract the stigma associated with STI testing by treating the testing in the same way that they treat other testing: as vital medical services that can help patients and their providers determine how to manage the patients’ conditions and what treatments may be appropriate.
Ann H. Carlson is a regular contributor to CLP.