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The decision by the Centers for Medicare & Medicaid to end add-on payments for drug-coated balloons (DCBs) without instating an ambulatory payment classification (APC) rate is a mistake, a group of clinicians argued.

The agency initiated coverage for DCBs with a transitional pass-through add-on payment in April 2015 and a new technology add-on payment in October that year. CMS then decided to let both run out in January 2018, opting to package the device costs into current available reimbursements for uncoated balloon angioplasty.

"The decision to neither create a new APC category nor assign DCB angioplasty a more appropriate APC category surprised professional societies, physicians, public policy organizations, and medical centers who argued against doing so ... out of concern over unintended patient consequences," wrote Mehdi Shishehbor, MD, of Case Western Reserve University School of Medicine in Cleveland, and colleagues in their viewpoint article published in the March 12 issue of .

"Furthermore, there is an extensive body of clinical trial evidence showing the clinical superiority of femoropopliteal DCB versus uncoated balloon angioplasty. These studies include three large randomized controlled trials and a number of comparative analyses that confirmed the cost effectiveness of DCB in both the United States and Europe," the group continued.

Shishehbor and colleagues said the new development appears "arbitrary," given strong recommendations for DCB use in the guidelines. "It is difficult to understand a decision that severely underpays for the most innovative and effective technologies supported by level 1 evidence of clinical benefit.

"If the goal of the CMS program with novel technology is to nudge hospitals to swallow the cost differences, then this is unfortunate, as many hospitals that are currently experiencing financial distress will not be able to assume the additional cost of DCBs resulting from the significant reduction in reimbursement. This will likely incentivize physician operators toward lower DCB use and have a negative impact on patient outcomes while increasing repeat procedures, especially in more financially disadvantaged environments."

Ultimately, the elderly and the poor will suffer for the lack of the add-on payments, the authors said.

"We hereby issue a call to action to professional societies, representing thousands of physicians and the millions of patients they treat, patient advocacy groups, and patients themselves to partner with CMS on how to improve payment systems so that incentives are appropriately aligned, supporting therapies based on their patient and societal value."

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