CMS Transitional Pass-Through Payment for Drug-Coated Balloon Reimbursement Expires
On January 1, 2018, the transitional pass-through (TPT) payment for drug-coated balloon (DCB) reimbursement by the United States Centers for Medicare & Medicaid Services (CMS) expired with the start of the CMS 2018 calendar year.
In order to facilitate access to devices it considers new and truly innovative, CMS grants TPTs on an application basis. As described in CMS guidance documents, TPTs are designed to enable adequate payment for use of designated devices while additional cost data are collected. The decision to grant a TPT is based on meeting certain criteria including newness to market, substantial clinical improvement versus currently available options, and increased cost determined to be "not insignificant."
However, TPTs are temporary by design, with expiry required to occur not less than 2 nor more than 3 years after initial establishment, after which the costs of the devices are to be incorporated into the procedure's Ambulatory Payment Classification rate. Initially established on April 1, 2015, the TPT applied to outpatient hospital usage of DCB platforms has expired on schedule.
Payments for the cost of DCBs are now packaged into the existing reimbursement structure for the endovascular procedures involving angioplasty for which they are billed. With the start of the 2018 calendar year, several femoropopliteal CPT codes saw increased reimbursement amounts, including CPT codes 37224 (angioplasty), 37225 (atherectomy with or without angioplasty), 37226 (stenting with or without angioplasty), and 37227 (stenting plus atherectomy with or without angioplasty).
Three DCBs are currently approved for use in the United States: Lutonix (Bard Peripheral Vascular, Inc.), In.Pact Admiral (Medtronic), and Stellarex (Spectranetics, a Philips company). All three platforms have been approved for use in femoropopliteal lesions; the Lutonix device is also indicated for use in arteriovenous fistulas. The expiry of the TPT applies to all outpatient hospital DCB applications.
Subsequent developments regarding reimbursement of these and other devices will be explored in future Endovascular Today coverage.