Medicare Coverage In Brief
This article was originally published in The Gray Sheet
Executive Summary
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
You may also be interested in...
News In Brief
Smith & Nephew launches orthobiologics spinout. CMS proposes CED for wound care gel. More news briefs.
Cytomedix Says Wound-Healing 510(k) Will Help Its Case With Medicare
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
Partisan Politics Returns To US FDA Congressional Oversight
The US FDA has stood out as an agency that tends to draw broad bipartisan support amid a generally rancorous and divided Congress. A House hearing, however, may be a sign that those days are over.