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Coding Corner: Clean Up Scrambled Charts for Clinical Trial Coding

Messy notes shouldn't leave you in a payment lurch

Coding and billing for patients in clinical trials can be a nightmare if you don't know which services are covered by Medicare and which aren't. Keep up with the rules with this refresher on which services you can bill, which codes to use, and which patients earn you reimbursement from insurers.

Coders groan when someone mentions clinical trials, because research patients' charts are usually a reimbursement disaster compared to those of other    patients. The reason for this discrepancy: Researchers have typically not been held to the same standards of documentation that they are for non-research patients, with services billed to third-party insurance carriers.
Know When a Trial Counts
In order to receive reimbursement for the services you provide to research patients, the trial itself must meet certain criteria, according to a National Coverage Decision released by CMS in September 2000. A "qualifying clinical trial" must satisfy all of the following requirements, says Jill Kuruc, MHA, CPC, CCS-P, clinical technical editor at Ingenix Inc. in New York, who presented on clinical trials at the 75th Annual AHIMA National Convention in Minneapolis:
The trial assesses an item or service that is (or would be) covered by Medicare or an intermediary.  If the item/service being tested is something that's already excluded from Medicare, it's also off-limits for clinical trial reimbursement. But if it's an item/service that usually warrants such payment, such as doctors' services, diagnostic tests, or durable medical equipment, it's in.
The trial has a therapeutic intent. Medicare won't pay if the trial is merely trying to discern whether a substance is harmful or just attempting to glean more knowledge about a particular disease or condition. The research must be aimed at discovery of an item/service that would directly improve patient treatment.


The trial enrolls beneficiaries who are already diagnosed with the condition or disease.  If the researcher's trial is testing a therapeutic intervention, the participating patients must have been previously diagnosed with the disease - healthy, control volunteers won't make the payment cut. But if the trial is evaluating a diagnostic tool, healthy patients function as a legitimate control group.
The trial meets a standard of desirability. The most subjective of the four criteria, "desirable characteristics" include scientific integrity, having a design appropriate to its purpose, compliance with government regulations, and sponsorship by a professionally solid entity. Also, the trial must walk the thin line between not duplicating previously completed studies and being sufficiently supported by known scientific information.
Go With the Rules You Know
Even after the clinical trial meets these qualifications, you might not get paid for all the associated services. But here's the [...]

- Published on 2004-01-02