Could ICD-10 delay spur innovation?

August 27, 2014 in Medical Technology

The Protecting Access to Medicare law enacted earlier this year is rather ignominiously known for delaying the inevitable ICD-10 conversion, but it could also speed up a part of the health system that’s just as sorely needed.

A provision tucked into the Protecting Access to Medicare law could go a long way toward accelerating the development and access routes of new diagnostic tests, as Myrl Weinberg, chief executive officer of the National Health Council, argued recently.

For some time, there has been a multi-year lag between the development of diagnostics and its availability in the United States, notably for companion diagnostics that help guide certain treatments and identify patients most likely to benefit.

In the American Journal of Pharmacy Benefits, Weinberg points to the case of a test identifying the protein known as human epidermal growth factor receptor 2, which can be used to determine whether breast cancer patients should take Herceptin, a drug that interferes the growth factors.

The Food and Drug Administration approved the HER2 test in 1999, but the Centers for Medicare Medicaid Services reimbursement code for it wasn’t created until 2004.

“That meant women with breast cancer had to gamble on whether to undergo Herceptin therapy, not knowing if it was the right treatment option for them, because there was no assigned code for ordering or paying for the HER2 test,” Weinberg wrote.

Myriad other diagnostics take years before benefiting patients, but change may be on the horizon, Weinberg contended, thanks to two “game-changing” provisions in the same law that delayed ICD-10.

The law establishes a means for getting advanced diagnostics to patients faster and a process to promote high-value diagnostics that help personalize care across a range of diseases.

Under the new law, a temporary Healthcare Common Procedure Coding System code can be assigned to tests after they are cleared or approved by the FDA for up to two years. Existing approved tests caught in the limbo of code assignment must have temporary HCPCS codes by January 2016.

Weinberg noted that the new law should also go some ways to reforming and improving reimbursement rate setting for new tests to prioritize the most high-value diagnostics that can direct patients to the best treatments, or, as in the case of HER2, help them determine in advance whether they are likely to respond and thus help those that wouldn’t benefit from drugs avoid them.

The law authorizes the creation of a new panel to recommend reimbursement for new diagnostics, rather than rely on the current system whether new diagnostics are assigned rates comparable to the most similar test already in use. That panel, which the Secretary of Health and Human Services must appoint by July 2015, is charged with considering the improvement in patient care and the differential between the cost of developing and administering the new test compared with an existing option. 

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