CMS Further Increases Reimbursement for Outpatient Use of Drug-Coated Balloons


June 9, 2015—The US Centers for Medicare & Medicaid Services (CMS) has improved the pass-through payment for drug-coated balloons (DCBs) under the Medicare hospital outpatient prospective payment system. The purpose of the reimbursement is to cover additional cost to hospitals in the United States for DCB treatment of Medicare beneficiaries in the outpatient setting.

There are two DCB devices commercially available in the United States. The US Food and Drug Administration approved the Lutonix 035 DCB (C.R. Bard, Inc.) in October 2014, and the agency approved the In.Pact Admiral DCB (Medtronic plc) in January 2015. Both devices are also available in Europe.

According to an announcement from Bard, CMS determined that costs associated with DCBs were not included in the 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 April 1, 2015.

In February 2015, Bard and Medtronic announced that CMS approved a transitional pass-through payment for peripheral vascular DCB use under the Medicare hospital outpatient prospective payment system. This reimbursement provision became effective on April 1, 2015 with a Healthcare Common Procedure Coding System code of C2623 (catheter, transluminal angioplasty, drug-coated, non-laser). At the time of the previous announcement, Medtronic advised that CMS was also reviewing a similar provision for use of the DCB in the inpatient setting, with a decision on the additional new technology add-on payment possible sometime this summer.


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