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.
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