Spiration, Inc. announced that the Centers for Medicare and Medicaid Services (CMS) has approved a new technology add-on payment (NTAP) for IBV Valve System use in the hospital inpatient setting to control prolonged air leaks or air leaks likely to become prolonged following lobectomy, segmentectomy or lung volume reduction surgery. The IBV Valve received a Humanitarian Device Exemption (HDE) approval for this indication in October 2008.
The new technology add-on payment is used by CMS as a means to correct for inadequate payment of new technologies under the existing Medicare payment groupings, called Medicare Severity Diagnosis Related Groups (MS-DRGs). CMS regulation considers the NTAP “additional payment when it represents an advance in medical technology that substantially improves, relative to technologies previously available, the diagnosis or treatment of Medicare beneficiaries.”
“The approval of this NTAP represents a significant accomplishment for Spiration. Only eight products have received an NTAP approval since the payment was implemented in 2001, and this is the only NTAP application approved by CMS in the last two years,” said Rick Shea, president and CEO, Spiration. “We are pleased that CMS recognizes the IBV Valve System as a substantial clinical improvement for controlling certain prolonged post-operative air leaks, which can be a significant and costly complication of lung surgery.”
New technology add-on payment is made when the technology is used in the inpatient setting and meets three criteria: i) newness, ii) substantial clinical improvement to existing therapeutic options, and iii) certain cost thresholds as defined by regulation.