Medicare Coverage Analysis Tool
for Drug, Biologics and Diagnostic Intervention Studies
Trial Name and HIC #
PI/Sponsor
Step #1: Determine if the trial is considered a Medicare “qualifying” clinical trial
A Medicare “qualifying” Clinical Trial needs to meet all four criteria:
 The subject or purpose of the trial must be evaluation of an item or service that
falls within a Medicare benefit (e.g. evaluates an item or service that involves
physician visits, durable medical equipment, diagnostic intervention) and is not
statutorily excluded from coverage (e.g. cosmetic surgery, hearing aids)
 The trial has therapeutic intent (the trial must not be designed exclusively to test
toxicity or disease pathophysiology)
 Trial of therapeutic intervention must enroll patients with diagnosed disease
rather than healthy volunteers. Trials of diagnostic intervention may enroll
healthy patients in order to have a proper control group.
 Trial is considered “deemed” to meet the seven desirable characteristics of a
clinical trial (Must meet one of the following: (a) sponsored by NIH, CDC,
AHRQ, HCFA, DOD or VA; (b) supported by centers or cooperative groups that
are funded by the NIH, CDC, AHRQ, CMS, DOD or VA; (c) conducted under an
investigational new drug application (IND) reviewed by the FDA; or (d)
determined by the HIC to be IND exempt under 21 CFR 312.2(b).
If all 4 criteria listed above are met and the trial is investigating a drug, biologics or
diagnostic intervention trial it is considered a Medicare “Qualifying” trial. Routine costs
associated with the Medicare “qualifying” trials may be billed to Medicare. (For
individuals participating in clinical trials with health care insurance through a private
insurer carrier, pre-authorization from the individual’s carrier may need to be obtained
Worksheet #2 Version 6/27/2012
prior to billing the insurer for the routine care costs associated with the trial.)
Step #2 Determine which services should be reimbursed by Sponsor and what services
might be billed to the insurer/patient.
For a Medicare “qualifying” clinical trial, the following items and services may be considered for
coverage by the patient’s insurer or patient, if the sponsor is not paying for them (covered items
and services):
A. Items/services typically provided absent a clinical trial (e.g. conventional care)
B. Items or services required solely for the provision of the investigational item or service
(e.g. administration of a non-covered chemotherapeutic agent), the clinically
appropriate monitoring of the effects of the item or service, or the prevention of
complications
C. Items/services needed for reasonable and necessary care arising from the provision of
an investigational item or service in particular, for the diagnosis or treatment of
complications.
The following items and services should not be billed to the patient’s insurer (non-covered items
and services), even if the trial is a Medicare “qualifying” trial:
A. The investigational item or service itself, unless otherwise covered outside of the
clinical trial
B. Items and services statutorily excluded from coverage by our Local Medicare
Contractor or national non –coverage (i.e. cosmetic surgery, hearing aids)
C. Items and services provided solely to satisfy data collection and analysis needs and
that are not used in the direct clinical management of the patient (e.g. monthly CT
scans for a condition usually requiring a single scan)
D. Items and services customarily provided by the research sponsors free of charge for
any enrollee in the trial.
Categorize services or items should be reimbursed by the sponsor and which services may be
billed to the subject and/or insurer
Service or item
time point required
cost to be covered by sponsor or patient (insurer)
YMG Patient Financial Services, YNHH and other providers need to ensure routine care
services associated submitted to Medicare for reimbursement are coded with specific
procedure modifiers and a specific diagnosis code. Please ensure they are informed when
particular patient is receiving services or items associated with a clinical trial.
Worksheet #2 Version 6/27/2012
Worksheet #2 Version 6/27/2012