CMS grants new technology add-on payment for inpatient use of Medtronic’s drug-coated balloon


The US Centers for Medicare and Medicaid Services (CMS) has granted a New Technology Add-on Payment for Medtronic’s IN.PACT Admiral drug-coated balloon under the Medicare hospital inpatient prospective payment system.

The add-on payment will help reimburse hospitals for the incremental costs of using drug-coated balloons and support patient access in the inpatient setting to this medical technology, which Medtronic says “represents a significant improvement to the standard of care for peripheral arterial disease in vessels above the knee”.

“Medtronic has been leading the efforts with CMS to enhance access to drug-coated balloon technology for the Medicare population, based on the substantially improved clinical outcomes in patients with peripheral arterial disease in the superficial femoral artery treated with the IN.PACT Admiral technology, including significantly fewer repeat interventions and improved quality of life for these patients,” said Brian Verrier, vice president and general manager of Peripheral Vascular, a business in Medtronic’s Aortic and Peripheral Vascular division. “This decision will ultimately help to improve patient access to the IN.PACT Admiral, which provides significant improvement to the standard of care.”

For a new technology to qualify for an add-on payment in the inpatient setting it must demonstrate a substantial clinical improvement relative to predecessor technology and meet specific cost thresholds. The add-on payment will provide hospitals with a payment, in addition to the DRG reimbursement, of up to 50% of the cost of a drug-coated balloon, and is expected to last for a period of two to three years. The add-on is effective in CMS’ fiscal year 2016 starting 1 October 2015 and has been assigned a maximum payment of US$1,035.72 per case for the 2016 financial year.

“The add-on decision provides further validation of CMS’ determination that the use of drug coated balloons significantly improves clinical outcomes for peripheral arterial disease patients,” added Mark Turco, medical director, Aortic and Peripheral Vascular. “The IN.PACT Admiral has demonstrated the best clinical outcomes ever reported for this disease state and has been proven to reduce the need for costly repeat procedures that are commonly associated with other available interventional therapies.”