Inadequate Reimbursement Threatens Monkeypox Lab Testing Response

You get what you pay for. And if the current inadequate reimbursement rates for monkeypox testing aren’t addressed—and soon—the US effort to contain the spread of the disease may suffer. That warning comes not only from the American Clinical Laboratory Association (ACLA), but also public health experts around the country.

Commercial Labs Step Up to Monkeypox Test Challenge

Rapid scale up and decentralization of lab testing is a critical component of the Biden administration’s monkeypox response strategy. As during the COVID-19 crisis, the US Centers for Disease Control and Prevention (CDC) developed and distributed a test to detect the virus in the early days of the outbreak. However, the government is once more asking commercial labs to drive rapid expansion of testing capacity.

And that’s just what the industry has done. The CDC has teamed with large commercial testing labs to create and ramp up production and distribution of their own laboratory developed tests (LDTs) for monkeypox on an accelerated basis. Those five labs, including Quest Diagnostics, LabCorp, Aegis Sciences, Mayo Clinic Laboratories, and Sonic Healthcare, are providing capacity of about 80,000 tests per week. (See, “CDC, Major Laboratory Companies Launch New Tests for Monkeypox,” Diagnostic Testing & Emerging Technologies, July 2022).

The Monkeypox Reimbursement Controversy

The tests are there and people are receiving them. The problem is that labs are subsidizing the effort out of their own pockets. In response to an ACLA letter requesting clarification of monkeypox billing, coding, and coverage rules, the Centers for Medicaid & Medicare Services (CMS) said that Medicare would pay for the tests when a health professional orders them.

However, the agency hasn’t yet issued a national coverage determination (NCD) for monkeypox. Instead, it’s left it to the Medicare Administrative Contractors (MACs) to establish their own reimbursement rates for monkeypox tests. Those MAC rates turned out to be alarmingly low. For example, Novitas, which manages two jurisdictions covering 11 states and the Veterans Affairs (VA) healthcare network, set reimbursement at just $51.31 per test; but that’s generous compared to the $35.09 that Noridian is paying to labs in California and the other 12 states it manages.

“Both of these rates do not align with ACLA’s recommendations and do not account for the inputs required to run a monkeypox test,” the ACLA wrote in its Aug. 19 letter to CMS  administrator Chiquita Brooks-LaSure. “This raises significant concerns that an inadequate payment rate may impact patient access to testing for a pathogen that is currently declared a public health emergency in the United States.”

The ACLA called on CMS to set a national rate of $76.97, a figure it derived by applying a 1.5 multiplier to the Zika virus testing reimbursement rate while also factoring in the costs of personal protective equipment and other extra resources needed to provide monkeypox tests.

Takeaway

So far, the major monkeypox testing labs have yet to weigh in one way or the other on the ACLA’s contentions. However, public health experts have acknowledged that it has been the commercial labs that have been bearing the load for monkeypox testing. If those labs aren’t properly reimbursed, “they’re just not going to engage,” cautions Amesh Adalja, a senior scholar with the Johns Hopkins Center for Health Security, in an article published by MedTech Dive. And, Adalja adds, if commercial labs don’t engage, “we’ll be stuck with CDC-affiliated labs which are woefully inadequate.”

The ACLA is also asking CMS to clarify Medicare and commercial insurance coverage rules so that labs can be assured that they’ll get paid before they invest in ramping up capacity for monkeypox testing. Without such certainty, they’re unlikely to make the commitment.

The ACLA noted that it’s dedicated to ensuring patients have access to monkeypox testing and will “continue to collaborate with the federal government writ-large on this response – including on reimbursement for testing.”