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Office of Research Administration
Medicare Coverage Analysis Determination of Qualifying Trial
(Not applicable for device trials)
Medicare Coverage Analysis should be performed prior to the initiation of a clinical trial to assure the proper billing of services. The preliminary analysis may be performed by the PI/study coordinator. The Office of Research Administration (ORA) will assist in the process if requested. Please complete the checklist below, sign and forward to ORA. Please note that this is a tool only to assist you with your determination.
SECTION I
_________________________________________ ____________________
Principal Investigator Signature Principal Investigator Printed Name Date
SECTION II
The Medicare National Coverage Determination (NCD) on Clinical Trials states that Medicare covers the routine costs of qualifying clinical trials, as well as reasonable and necessary items and services used to diagnose and treat complications arising from participation in all clinical trials.
A qualifying trial is one that meets all 3 criteria in Parts I and II and at least one of the criteria outlined in Part III. If a study does not meet the criteria for a qualifying trial, then none of the routine costs (conventional care) can be billed to Medicare.
If the trial is a qualifying trial, the Principal Investigator must be able to provide objective sources such as peer-reviewed literature or medical practice guidelines that support the designation of all conventional care performed in the study that is to be billed to Medicare.
Please complete the questions below to assist you in determining if this study is a qualifying trial as defined by Medicare.
PART I- REQUIREMENTS FOR MEDICARE COVERAGE OF ROUTINE COSTS OF DRUG TRIALS
Question Yes No Notes1. Does the investigational item fall within a Medicare Benefit category (e.g., physicians' service, durable medical equipment, diagnostic test) and is not statutorily excluded from coverage (e.g., cosmetic surgery, hearing aids)?
FORMCHECKBOX FORMCHECKBOX 2. The trial must not be designed exclusively to test toxicity or disease pathophysiology. Does the trial have therapeutic intent?
FORMCHECKBOX FORMCHECKBOX 3. Does the trial enroll patients with a diagnosed disease (trials of diagnostic interventions may enroll healthy patients in order to have a proper control group)?
FORMCHECKBOX FORMCHECKBOX
PART II DESIRABLE CHARACTERISTICS
Desirable Characteristics Yes No If yes, specify/notes1. Is the principal purpose of the trial is to test whether the intervention potentially improves the participants' health outcomes?
FORMCHECKBOX FORMCHECKBOX 2. Is the trial well-supported by available scientific and medical information or it is intended to clarify or establish the health outcomes of interventions already in common clinical use?
FORMCHECKBOX FORMCHECKBOX 3. Does the trial meet the criteria of NOT unjustifiably duplicating existing studies? FORMCHECKBOX FORMCHECKBOX 4. Is the trial design is appropriate to answer the research question being asked in the trial?
FORMCHECKBOX FORMCHECKBOX 5. Is the trial is sponsored by a credible organization or individual capable of executing the proposed trial successfully?
FORMCHECKBOX FORMCHECKBOX
PART III DETERMINATION OF DEEMED TRIAL
Question Yes No If yes, specify/notes1. Is the study funded by NIH, CDC, AHRQ, CMS, DOD or VA?
FORMCHECKBOX FORMCHECKBOX
2. Is the study funded by a cooperative group that receives funding by NIH, CDC, AHRQ, CMS, DOD or VA?
FORMCHECKBOX FORMCHECKBOX 3. Is the study conducted under an investigational new drug application (IND)? If yes, list IND#
FORMCHECKBOX FORMCHECKBOX 4. Is the study exempt from an IND under 21CFR312.12(b)(1)?
FORMCHECKBOX FORMCHECKBOX
PAGE \* MERGEFORMAT 2
Is the Sponsor reimbursing the institution for all study related procedures?
YES FORMCHECKBOX
NO FORMCHECKBOX
If you answered YES, please sign and email the form to HYPERLINK "mailto:mluchs@uthsc.edu" mluchs@uthsc.edu or it may be faxed to ORA at 901-448-3943. Make sure that this determination is consistent with the Informed Consent Form.
If you answered NO, please complete Section II, sign and email the form to HYPERLINK "mailto:mluchs@uthsc.edu" mluchs@uthsc.edu or fax to ORA at 901-448-3943.
Principal Investigator Name:
Department:
Study Coordinator:
Study Title:
Study Sponsor:
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