Full article reprinted from "The Gray Sheet" - May 11, 2009
Each of this year's applicants for new-technology add-on Medicare payments are a long shot, CMS suggests in its proposed 2010 inpatient payment rule. Find out more...
Full article reprinted from "The Gray Sheet" - May 11, 2009
Each of this year's applicants for new-technology add-on Medicare payments are a long shot, CMS suggests in its proposed 2010 inpatient payment rule.
Five products - four devices and one drug - are up for the bonus reimbursement next year. The agency does not provide definitive up or down proposals in its May 1 draft rule, but it seriously questions whether each of the products measures up to all three add-on payment thresholds.
CMS notes that it is considering an additional factor to help determine whether a product seeking a new-technology add-on payment is, in fact, new; however, the additional criterion does not appear to make it much easier to meet the mark.
The agency says that it may be appropriate to analyze whether a new product or indication involves the treatment of the same or similar type of disease as an existing product, and the same or similar patient population.
The applicants for add-on payments are Monteris Medical's AutoLITT magnetic resonance imaging-guided tumor ablation catheter; InfraReDx's LipiScan coronary imaging system; Spiration's IBV lung surgery valve system; TherOx's Downstream supersaturated oxygen therapy; and Genzyme's Clolar injection for acute myeloid leukemia.
Three of the five applicants have yet to gain FDA approval, which they would need by July 1 to even have a shot at the 2010 bonus. TherOx's device, intended to help preserve heart muscle and function following a heart attack, received a negative FDA panel vote in March, lowering its chances further (2"The Gray Sheet" March 23, 2009, p. 11).
The add-on payments are meant to provide sufficient reimbursement to promising new technologies during the post-launch period when CMS does not yet have enough data to calculate an accurate long-term payment level.
Typically, there is about a two- to three-year lag between launch and when enough Medicare claims data are available to determine long-term payment. Products in this phase may qualify for the add-on if the manufacturer proves that the cost of the product far outpaces any existing relevant payment group and that it offers a "substantial clinical improvement" over existing technologies.
"The Gray Sheet" gives you 51 issues per year filled with useful articles that will help you meet your business and regulatory objectives. Sign up for your 30-day, risk-free trial of "The Gray Sheet" today.
.jpg)
