W. L. Gore is requesting new technology add-on payment from Medicare for its TAG thoracic aortic aneurysm (TAA) endograft based on data showing it to be significantly safer than surgical repair.

During a Feb. 23 new-technology "town hall" meeting at CMS' headquarters in Baltimore, the firm was one of seven companies attempting to demonstrate a "substantial clinical improvement" over existing treatments.

Gore presented data from 284 patients enrolled in the TAG IDE trials, 532 TAA surgery patients from CMS' 2003 MedPar database and about 1,200 patients from outside the U.S.

According to Gore, the studies showed that minimally invasive TAA repair with TAG demonstrates a substantial clinical advance over traditional surgery because endovascular repair is associated with significantly lower rates of adverse events including paraplegia and renal failure.

"For patients who are candidates for endovascular repair, [TAG] reduces the negative physiological effects of the extremely invasive direct surgical exposure and the prolonged intraoperative interruption of blood flow," Gore presenter Don Goffena explained.

"Patients who are at high risk for surgical repair may now have an alternative to the prospect of living with a condition that carries a significant risk of rupture and death," he added.

Gore's application for an add-on payment was endorsed at the meeting by Society for Vascular Surgery Government Relations Committee Chair Robert Zwolak, MD/PhD, and Medtronic Health Policy & Payment Director Jeff Farkas.

Medtronic, which expects its Talent TAA endograft to be approved by early 2006, would qualify for add-on payment in the event that Gore's application is approved.

Implemented in 2000, the new technology add-on payment program is intended to provide funding for expensive technologies that demonstrate a substantial advance over the current standard of care, but which have not been on the market long enough to generate reliable cost data.

TAG easily will meet the newness criteria, since the device has not yet been approved. On Jan. 13, FDA's Circulatory System Devices Panel voted 8 to 2 in favor of recommending approval of the endograft (¹ Also see "Panel Critiques TAG Graft Study Size, But Deems Approval “Common Sense”" - Medtech Insight, 17 January, 2005., p. 5).

While the Medicare Modernization Act of 2003 defines "new" as the two-to-three year timeframe after data begin to become available, CMS has been using the more restrictive two-to-three years after FDA approves a device. New technologies must also meet a cost threshold to qualify.

CHF Solutions applied for FY 2006 add-on payment for its Aquadex System 100 fluid reduction system for congestive heart failure. Chief Medical Officer Paul Sobotka, MD, cited data from the SAFE and EUPHORIA trials showing that the system can safely and effectively remove CHF-related fluid overload for up to eight hours. In contrast, data supporting diuretic drugs - the current standard of care - is sparse, according to Sobotka.

Despite the data presented on behalf of the Aquadex system, it faces an uphill battle in justifying an add-on payment. CMS rejected CHF Solutions' add-on application last year for failing to demonstrate a substantial clinical improvement, and because Aquadex was first 510(k)-cleared by FDA in June 2002, it does not meet CMS' definition of "new."

Medtronic also presented data supporting an add-on payment for its InFuse bone graft for tibia fractures, which was rejected last year (see ² Also see "Medtronic Seeks InFuse Add-on, Proposes Clearer Definition Of “Similarity”" - Medtech Insight, 28 February, 2005.).

Other applicants presenting at the meeting were Medtronic ( Restore rechargeable implantable neurostimulator); IntraLuminal Therapeutics ( Safe-Cross total vascular occlusion crossing system); Johnson & Johnson/DePuy Spine ( Charité artificial disc); and Stryker Orthopedics ( Trident ceramic-on-ceramic hip replacement system) (see chart: ³ Applicants For FY 2006 Medicare New Tech Add-on Payments).

Boston Scientific submitted an application for its WingSpan intracranialstent system, but opted against presenting at the meeting.

The agency will publish preliminary decisions on the new tech add-on applications in the FY 2006 hospital inpatient prospective payment system proposed rule, slated for release in May. The final rule will be published in August.

Gore Seeks Add-On Payment For TAG Endograft In Advance Of FDA Approval

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