Facts are stubborn, but the desire to ignore them in the face of evidence should be inexcusable.

University Hospitals Cleveland Medical Center (UHCMC) cardiology interventionalists authored a new article in the Journal of the American College of Cardiology entitled, “Public Health Impact of the Centers for Medicare and Medicaid Services Decision on Pass-Through Add-On Payments for Drug-Coated Balloons,” that is critical of the Center of Medicare and Medicaid's (CMS) recent decision to not pay for drug-coated balloons despite their clinical superiority.

The CMS decided to end transitional pass through (TPT) add-on payment for drug-coated balloons at the first of the year without creating a new payment classification for the devices.

The outpatient hospital TPT add-on payment program is specifically designed to support patient access to new technologies that meet stringent criteria pertaining to clinical effectiveness.

Mehdi Shishehbor, MD, MPH, PhD, Director, Interventional Cardiovascular Center at UHCMC and professor of medicine at Case Western Reserve University School of Medicine, was the lead author on the article that highlights the disconnect between the CMS’s decision not to create a new ambulatory payment classification.

Drug-coated balloons have been commercially available since February of 2015, dramatically improving outcomes for heart attack, peripheral artery disease, stroke, and kidney failure patients.

“We believe this decision is more in line with a rigid fee-for-service payment system than a value-based one that encourages quality over quantity,” said Shishehbor. “The disadvantages will fall on the elderly and the poor who will need additional procedures because they are receiving uncoated balloon angioplasty.”

The article criticizes the CMS decision because it does not incorporate ‘value-based judgments’ instead justifying the decision on the ‘principal of averaging’ where payment isn’t supported because of higher overall costs associated with drug-coated balloons.

“We completely disagree with the CMS’s description or justification for not creating a new payment classification,” said Shishehbor. “Because lower extremity angioplasty with more expensive balloons is superior to uncoated balloon angioplasty, angioplasty with uncoated balloon should rarely be used as a standalone or definitive therapy.”

“The CMS’s justification using the principals of averaging implies that both procedures have similar clinical efficacy and are interchangeable saying the costs will balance out over time. This assumption by the CMS is erroneous.”

The article continues to state that treatment with uncoated balloons is substandard given the 4-year outcomes with drug-coated balloons and stents. Additionally, the authors call to action for more engagement from all governmental bodies, including Congress, to address the current rigid CMS system.

“The current CMS decision will negatively impact drug-coated balloon usage, resulting in poorer vessel patency and quality of life,” said Shishehbor. “Additionally, higher readmission rates will be the result and overall health-care costs will continue to mount.”