Learn more about Qualifying Clinical Trials for Devices. Treatment of healthy volunteers unless used as controlsĬosmetic surgery, some prosthetics, herbal remedies, relaxation therapies, etc. Items or services needed for reasonable and necessary care arising from the provision of an investigational item or service (e.g., hydration fluids as part of chemotherapy treatment) Items or services provided solely to determine trial eligibility Items or services customarily provided by the sponsors free of charge Items or services typically provided absent a clinical trialĪn investigational item or service itself if used in a non-FDA approved wayĬlinically appropriate monitoring of the effects of the item or service (e.g., monitoring side effects or complications) Items or services provided solely to satisfy data collection and analysis needs that are not used in the direct clinical management of the patient or not used to monitor the effects of the item or service (e.g., plasma biomarkers) Items or services required solely for the provision of the investigational item or service (e.g., infusion) What are Routine Costs Provided to Qualifying Clinical Trials? See the NCD Alphabetical Index for CMS’ indications and limitations for common procedures. *Some commonly ordered tests may not be considered “reasonable and necessary” under the NCD, or may be reasonable and necessary at some frequency less than that required by the sponsor in a protocol. Qualifying Criteria (All three crit eria must be "Yes"): Under the National Coverage Decision (NCD), Medicare will cover those routine costs of qualifying clinical trials and the costs of items and services that are reasonable and necessary to diagnose and treat complications arising from. Has an IND number: Trial conducted under an investigational new drug application (IND) reviewed by the FDA The National Coverage Decision (NCD) offers specific guidance concerning Clinical Trials Billing.Is supported by centers or cooperative groups that are funded by the NIH, CDC, AHRQ, CMS, DOD and VA.Is funded/supported by NIH, CDC, AHRQ, CMS, DOD or VA.Deemed Automatically Qualifying Trial (Any one criterion must be "Yes"):.Under the National Coverage Decision (NCD), Medicare will cover those routine costs of qualifying clinical trials and the costs of items and services that are reasonable and necessary* to diagnose and treat complications arising from participation in all clinical trials ( Centers for Medicare and Medicaid Publication 100-3, Ch 1, Part 4, Section 310.1). The National Coverage Decision (NCD) offers specific guidance concerning Clinical Trials Billing.
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