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WITHDRAWAL OF FY 2010 NEW TECHNOLOGY ADD-ON PAYMENT APPLICATIONS CMS would like to inform the public, that it has been notified by Monteris Medical (the manufacturer of the AutoLITT™ system), TherOx Inc. (the manufacturer of the TherOx Downstream System), and Genzyme Oncology (the manufacturer of CLOLAR ® (clofarabine) injection) that they are withdrawing their FY 2010 new technology add-on payment applications for consideration from the FY 2010 IPPS Final Rule. TRACKING FORMS SUBMITTED BY APPLICANTS FOR FY 2010 ARE POSTED BELOW IN THE DOWNLOADS SECTION. APPLICATION INFORMATION FOR FY 2010 The deadline for FY 2010 IPPS New Technology Applications was November 17, 2008. BACKGROUND Sections 1886(d)(5)(K) and (L) of the Act establish a process of identifying and ensuring adequate payment for new medical services and technologies under the IPPS. Section 1886(d)(5)(K)(ii)(I) of the Act specifies that the process must apply to a new medical service or technology if, "based on the estimated costs incurred with respect to discharges involving such service or technology, the DRG prospective payment rate otherwise applicable to such discharges under this subsection is inadequate." Section 1886(d)(5)(K)(vi) of the Act specifies that a medical service or technology will be considered "new" if it meets criteria established by the Secretary after notice and opportunity for public comment. Section 412.87(b)(3) provides that, to receive special payment treatment, new technologies meeting this clinical definition must be demonstrated to be inadequately paid otherwise under the DRG system. For applicants for new technology add-on payments for FY 2005 and forward, we established the criteria that will be applied to assess whether technologies would be inadequately paid under the DRGs the lesser of 75 percent of the standardized amount increased to reflect the difference between costs and charges (based on the national case weighted cost-to-charge ratio) or 75 percent of 1 standard deviation (based on the logarithmic values of the charges and transformed back to charges) beyond the geometric mean standardized charge for all cases in the DRGs to which the new technology is assigned (or the case weighted average of all relevant DRGs, if the new technology occurs in many different DRGs). In order to qualify for the new technology add-on payments, a specific technology must be "new" under the requirements of §412.87(b)(2) of our regulations. The statutory provision contemplated the special payment treatment for new technologies until such time as data are available to reflect the cost of the technology in the DRG weights through recalibration (no less than 2 years and no more than 3 years). Section 412.87(b)(1) of our existing regulations provides that a new technology will be an appropriate candidate for an 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 (see the September 7, 200l final rule (66 FR 46902)). Applicants for FY 2010 must submit a formal request, including a full description of the clinical applications of the technology and the results of any clinical evaluations demonstrating that the new technology represents a substantial clinical improvement, along with data to demonstrate the technology meets the high cost threshold. The new technology add-on payment policy provides additional payments for cases with high costs involving eligible new technologies while preserving some of the incentives under the average-based payment system. The payment mechanism is based on the cost to hospitals for the new technology. Under §412.88, Medicare pays a marginal cost factor of 50 percent for the costs of the new technology in excess of the full DRG payment. If the actual costs of a new technology case exceed the DRG payment by more than the estimated costs of the new technology, Medicare payment is limited to the DRG payment plus 50 percent of the estimated costs of the new technology. For a more complete reading on Add-On Payments for New Services and Technologies, please view the Inpatient Prospective Payment System (IPPS) final rule published on August 18, 2008. The final rule and all other regulations and notices are located in the left navigational area of this page.
Page Last Modified: 06/29/2009 11:59:45 AM
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