Regional Carriers Delay Coverage Policy On Home Testing Of Sleep Apnea
This article was originally published in The Gray Sheet
Executive Summary
Regional Medicare administrative contractors are delaying implementation of a local coverage policy intended to expand reimbursement of continuous positive airway pressure (CPAP) devices, the contractors announced Aug 22
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Piper Jaffray Healthcare Conference In Brief
Qiagen: Firm will pursue full pre-market approval for Ensemble, "the first ever continuous loading molecular diagnostic instrument," Qiagen Senior VP of R&D Jim Godsey announced Dec. 2 at the Piper Jaffray Healthcare Conference in New York City. Ensemble is compatible with Hybrid Capture human papilloma virus screening technology. According to Qiagen, the Ensemble JC2000 instrument can run 2,000 specimens per one eight-hour cycle and 5,000 specimens in two back-to-back shifts. The company also is developing a model for low-to-medium throughputs. Clinical trials, which likely will include 30,000-40,000 specimens, will begin in the first half of 2009, Godsey says. Qiagen gained Hybrid Capture 2, the only FDA-approved molecular HPV screening test, when it acquired Digene in 2007. Qiagen dominates the U.S. HPV market now, but will soon face competition from Hologic/Third Wave's Cervista, which is pending PMA approval, and down the line, from Gen-Probe (Aptima) and diversified drug giant Roche (Amplicor)
Piper Jaffray Healthcare Conference In Brief
Qiagen: Firm will pursue full pre-market approval for Ensemble, "the first ever continuous loading molecular diagnostic instrument," Qiagen Senior VP of R&D Jim Godsey announced Dec. 2 at the Piper Jaffray Healthcare Conference in New York City. Ensemble is compatible with Hybrid Capture human papilloma virus screening technology. According to Qiagen, the Ensemble JC2000 instrument can run 2,000 specimens per one eight-hour cycle and 5,000 specimens in two back-to-back shifts. The company also is developing a model for low-to-medium throughputs. Clinical trials, which likely will include 30,000-40,000 specimens, will begin in the first half of 2009, Godsey says. Qiagen gained Hybrid Capture 2, the only FDA-approved molecular HPV screening test, when it acquired Digene in 2007. Qiagen dominates the U.S. HPV market now, but will soon face competition from Hologic/Third Wave's Cervista, which is pending PMA approval, and down the line, from Gen-Probe (Aptima) and diversified drug giant Roche (Amplicor)
Final CPAP coverage decision
CMS relaxes its standards for covering continuous positive airway pressure (CPAP) treatment for obstructive sleep apnea under a March 13 final coverage 1decision. The determination, largely in-line with a Dec. 14 CMS proposal, expands CPAP reimbursement to include situations in which sleep apnea is diagnosed with the combination of a clinical evaluation and a home monitoring device (Type II, III or IV) (2"The Gray Sheet" Jan. 7, 2008, p. 15). For other types of monitoring devices, CMS outlines coverage-with-evidence-development requirements. Medicare previously paid for OSA treatment only if diagnosed by a clinical assessment and confirmed by polysomnography in a sleep laboratory. The final decision also removes the need for two hours of continuous recorded sleep for diagnosis if a minimum number of apnea-associated events are identified in a shorter time period, and no longer requires that patients have "moderate to severe" OSA for CPAP reimbursement, where surgery is the likely alternative. CPAP device makers include ResMed, Philips/Respironics and Itamar Medical