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Clinical Research and Clinical Trial Professional and Technical Fee Billing: Difference between revisions
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Clinical Research and Clinical Trial Professional and Technical Fee Billing (view source)
Revision as of 11:18, February 7, 2017
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*Trials funded by: NIH, CDC, AHRQ, CMS, DOD, or VA | *Trials funded by: NIH, CDC, AHRQ, CMS, DOD, or VA | ||
*Trials supported by centers or cooperative groups that are funded by the NIH, CDC, AHRQ, CMS, DOD, and VA; | *Trials supported by centers or cooperative groups that are funded by the NIH, CDC, AHRQ, CMS, DOD, and VA; | ||
*Trials conducted under an investigational new drug application (IND) reviewed by the FDA; | *Trials conducted under an investigational new drug application (IND) reviewed by the FDA; or | ||
* | *Drug Trials that are exempt from having an IND number under 21 CFR 312.2(b)(1) will be deemed automatically qualified until qualifying criteria are developed and the certification process is in place. At that time, the principal investigators of these trials must certify that the trials meet the qualifying criteria in order to maintain Medicare coverage of routine costs. This certification process will only affect the future status of the trial and will not be used to retroactively change the earlier deemed status. | ||
===Routine Costs=== | ===Routine Costs=== | ||
Routine costs of a clinical trial include all items and services that otherwise would be generally available to Medicare beneficiaries (i.e., there exists a benefit category, it is not statutorily excluded, and there is not a national non-coverage decision) that are provided in either the experimental or control arm of a clinical trial. | Routine costs of a clinical trial include all items and services that otherwise would be generally available to Medicare beneficiaries (i.e., there exists a benefit category, it is not statutorily excluded, and there is not a national non-coverage decision) that are provided in either the experimental or control arm of a clinical trial. | ||