CMS approves removal of offset charge associated with pass-through payment for DCBs in the USA


The US Centers for Medicare & Medicaid Services (CMS) has approved the removal of offset charges associated with pass-through payment for drug-coated balloons (DCBs) under Medicare outpatient prospective payment system.

In February, CMS announced it approved a transitional pass-through payment for the Medtronic IN.PACT Admiral DCB under the Medicare hospital outpatient prospective payment system. In a statement Medtronic noted that, since February, the company has been leading collaboration with CMS to review policy in an effort to extend patient access to DCB technology, which provides significant improvement to the standard of care for treatment of peripheral arterial disease in the superficial femoral artery.

“We are excited by their decision to remove the device offset charge. The decision to reimburse the full cost of DCBs will ultimately help to improve patient access to IN.PACT Admiral DCB,” Medtronic said. The company added, “Recently approved by the US Food and Drug Administration (FDA) on the strength of clinical and economic data from multiple studies, the IN.PACT Admiral DCB offers patients a new therapy option that has demonstrated the best clinical outcomes ever reported (and published in peer-reviewed circulation) 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.”

Bard announced that CMS has improved the pass-through payment for the Lutonix DCB under the Medicare hospital outpatient prospective payment system. The company stated, “The purpose of the reimbursement is to cover additional cost to US hospitals for treating Medicare beneficiaries with the Lutonix DCB in the outpatient setting. After further review, CMS determined that costs associated with DCBs were not included in existing reimbursement for percutaneous transluminal angioplasty, stenting, or atherectomy procedures. Therefore, CMS is removing the device offset charge from the calculation and will reimburse the full cost of DCBs in these procedures. This reimbursement determination is retroactive to 1 April 2015.” The Lutonix 035 DCB is an angioplasty balloon coated with a therapeutic dose of the drug paclitaxel, and also utilises standard mechanical dilatation of the vessel to restore blood flow for patients with peripheral arterial disease in the femoropopliteal arteries.

Timothy M Ring, chairman and chief executive officer, commented, “This announcement is great news for patients. CMS has recognised that the Lutonix DCB meets an important patient need and has moved quickly to provide full reimbursement for this breakthrough technology in the outpatient setting.”