Providers sometimes will need to submit more patient data for claims payment so that the Centers for Medicare & Medicaid Services (CMS) can collect data for its Coverage with Evidence Development (CED) program. The revisions are part of changes to the National Coverage Determinations (NCDs). These modifications are now official, having been posted in draft form for comments on April 7, 2005. CMS made revisions based on public comments received before releasing this official CED guidance document.
The CED program generates data about the utilization and impact of the item or service so that Medicare can document the appropriateness of the item or service’s use, consider future coverage changes, and obtain clinical information to improve the evidence base upon which providers base their recommendations to patients. CED collects data in part to document outcomes of various services and items.
According to the official document, CMS may issue an NCD requiring that data be sent to a centralized database or registry. CMS also created 2 categories of CED – Coverage with Appropriateness Determination (CAD) and Coverage with Study Participation (CSP). A CAD is applicable when the item or service in question is deemed qualified for coverage but additional clinical data is needed to ensure that the item/service is provided appropriately. CSP allows coverage of certain items or services for which there is inadequate evidence to support reimbursement—if CMS determines that data-gathering in a clinical practice situation would yield important information about how the service or item affects beneficiaries’ health.
CMS already conditions Medicare coverage upon registry participation in 6 circumstances: PET for Alzheimer’s, PET for brain, cervical, ovarian, pancreatic, small-cell lung, and testicular cancers, implantable cardiodefibrillators, cochlear implants, an NIH colorectal cancer trial, and an NIH home oxygen trial. The CMS website lists more information about these requirements.
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