Medicare Compliance & Reimbursement

Get ready for extensive documentation demands.

After the Centers for Medicare & Medicaid Services' (CMS) recent announcement that it is re-thinking its national coverage determination (NCD) on clinical research coverage, the agency is now revising its guidance for NCDs that demand extra patient data. But whether CMS' revised approach will speed up coverage decisions or bog providers down in additional paperwork is still up in the air.

"Collecting additional patient data as part of the coverage process, Coverage with Evidence Development (CED), generates data on the utilization and impact of the item or service evaluated in the NCD," CMS says. The agency is using the extra patient data (in addition to normal claims data) as a "condition of payment."

"When CMS requires CED, the NCD review process might result in a decision to provide coverage only when certain data about patients' clinical conditions are collected," in addition to the standard claims data, the agency said in its July 12 announcement. Or CMS may decide to cover an item or service for beneficiaries who are participating in a clinical trial. The agency will "review these data collected under the auspices of CED to ensure that care provided conforms to the conditions stated in the NCD," CMS adds.

CMS has several objectives behind utilizing CED: to document how appropriate the use of the item or service is for Medicare benes under the current coverage; to anticipate any future coverage changes for the item or service; and to generate clinical data that will better inform providers who are recommending the item or service to patients.

"In the particular cases where this coverage approach is relevant, our new guidance provides for faster and more effective coverage coupled with more informed clinical decision making," CMS administrator Mark McClellan said in a July 12 statement.
 
Hidden benefits: "The CED process may also prove helpful when there have been significant barriers to conducting research about an item or service at the time of the NCD review," CMS says. In those cases, the agency continues, CMS may provide coverage for the item or service for Medicare benes who are enrolled in a clinical study of that item or service.

When CMS posted its draft document in early April 2005, it received many comments--on which the agency based its revised guidance document. The revised guidance document "introduces two precepts of CED--coverage with appropriateness determination (CAD) and coverage with studying participation (CSP)," CMS reports.

"Distinguishing these two types of CED provides clarity on CMS' rationale for collecting data and the legal bases that CMS may invoke in order to authorize this collection," the agency explains.

Bottom line: CMS' ultimate goal regarding CED is to speed benes' and providers' access to new technologies, McClellan notes.

"This policy should encourage [...]