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Cytomedix Says Wound-Healing 510(k) Will Help Its Case With Medicare

This article was originally published in The Gray Sheet

Executive Summary

Cytomedix's hard-won FDA clearance of its wound-healing device will lend strength to the company's pursuit of national Medicare coverage, the firm says

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Wound Therapy Firm Pushes For More Flexibility In Coverage-With-Evidence Conditions

CMS recently proposed to lift a long-established non-coverage policy for platelet-rich plasma wound therapy, but only for patients enrolled in a randomized trial. Manufacturer Cytomedix says a registry-based observational study would be a better approach.

Medicare Coverage In Brief

No coverage for PET infection Dx: CMS will maintain its noncoverage policy for fluorodeoxyglucose-positron emission tomography (PET) scans to diagnose chronic osteomyelitis (bone infection), infection from hip arthroplasty and fevers of unknown origin, it said March 19. The agency cites inadequate data, "including heterogeneity of cases, lack of consistent comparators, small samples sizes, missing data ... and poor methodologic structure." CMS decided against employing a coverage-with-evidence-development policy because nobody proposed a clinical study that would fulfill the requirements, the agency said. CMS already covers PET for diagnosing certain cancers and conditionally covers PET for other indications, including Alzheimer's, dementia and other cancers

Medicare Coverage In Brief

No coverage for PET infection Dx: CMS will maintain its noncoverage policy for fluorodeoxyglucose-positron emission tomography (PET) scans to diagnose chronic osteomyelitis (bone infection), infection from hip arthroplasty and fevers of unknown origin, it said March 19. The agency cites inadequate data, "including heterogeneity of cases, lack of consistent comparators, small samples sizes, missing data ... and poor methodologic structure." CMS decided against employing a coverage-with-evidence-development policy because nobody proposed a clinical study that would fulfill the requirements, the agency said. CMS already covers PET for diagnosing certain cancers and conditionally covers PET for other indications, including Alzheimer's, dementia and other cancers

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