Four Device Makers Apply For 2011 New-Technology Add-On Bonus

Full article reprinted from "The Gray Sheet" - December 14, 2009

CMS has received five applications from four device firms for its next round of new-technology add-on payments, including submissions for two products that did not qualify for the extra payment during previous attempts. Read more...

Four Device Makers Apply For 2011 New-Technology Add-On Bonus

Full article reprinted from "The Gray Sheet" - December 14, 2009

Under the program, hospitals can receive extra reimbursement for using promising new devices whose value is not yet represented under the Medicare agency's diagnosis-related-group (DRG) payment system.

However, the products must pass a relatively high threshold: they must demonstrate substantial clinical improvement over existing medical technology, meet a "newness" standard, and have FDA approval by July 1 of the year the application is judged.

For fiscal 2010, only one new applicant, the Spiration IBV Valve System, received the new-tech add-on payment under the hospital inpatient prospective payment system (IPPS) rule (The Gray Sheet' Aug. 10, 2009). The product helps control prolonged air leaks following lung surgery.

Monteris and InfraReDx Try Again

Monteris Medical is making a second attempt to receive a new-tech add-on payment for its Auto Laser Interstitial Thermal Therapy, or AutoLITT System, a magnetic resonance imaging-guided tumor ablation catheter.

The technology was FDA-cleared in May 2009 and is expected to be launched this month "following suggested and required updates to the technology," according to Monteris.

InfraReDx also made a second bid for an add-on payment for its LipiScan Coronary Imaging System . The device was 510(k)-cleared by FDA in 2008.

In the proposed 2010 IPPS rule, CMS raised concerns that the LipiScan may have been substantially similar to its 510(k) predicate - an InfraReDx near-infrared imaging system cleared in 2006 - and therefore not "new" (The Gray Sheet' May 11, 2009).

CMS also rejected a March 2009 application for an outpatient prospective payment system pass-through payment for LipiScan due to a lack of evidence demonstrating substantial clinical improvement over existing devices.

Some Applicants Still Pending FDA Review

InfraReDx also submitted an IPPS add-on payment application on behalf of its LipiScan IVUS (intravascular ultrasound) technology.

In its filing, the firm said it expects to submit a pre-market filing for the new product to FDA this month, with an FDA decision anticipated in the second quarter of 2010.

The LipiScan IVUS system uses intravascular spectroscopy to image coronary vessels.

Zimmer has a PMA under review at FDA for its proposed new-tech add-on technology, the Dynesys Dynamic Stabilization System.

Dynesys received 510(k) clearance in 2004 for use as an adjunct to fusion, and went on the market with that indication in 2005.

Zimmer is now seeking FDA approval for the system as a stand-alone, non-fusion device that would be used without bone graft to provide spinal alignment and stabilization in patients with leg pain who would otherwise be indicated for spinal fusion. On Nov. 4, however, an FDA advisory panel recommended against approval for this indication (The Gray Sheet'Nov. 9, 2009).

Nycomed Austria anticipates an April 5, 2010, FDA approval date for its add-on applicant, the TachoSil hemostatic and tissue sealing system. Indicated uses will be as a hemostatic adjunct in cardiovascular surgery and as a tissue sealant in lung surgery, the company states.

According to Nycomed, persistent air leaks from cardiothoracic procedures put patients at increased risk of morbidity and complications, and TachoSil can help manage such leaks.

The application deadline for the FY 2011 new-technology add-on payments was Nov. 20.

CMS plans a Town Hall meeting at its Baltimore headquarters on Feb. 10 to discuss each application. Successful applicants will be announced on publication of the 2011 IPPS next summer.

- Monica Hogan

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