In the past, sponsors of Investigational Device Exemption (IDE) clinical trials have absorbed most, if not all, of the costs associated with the trial by reimbursing physicians and facilities for services provided. More and more in today’s healthcare environment, typical reimbursement for physician services, facility costs, and trial devices, are being paid by Medicare and commercial carriers. While this may not yet be a well-known area of reimbursement, it is here to stay, and with some guidance from Medicare and commercial carriers, it does not have to be an “experiment” in obtaining payment for clinical trial services.

The Food and Drug Administration (FDA), in working with Centers for Medicare and Medicaid Services (CMS), gives clinical trials for medical devices two categories of designation . Category A: Experimental – innovative devices believed to be in class III for which “absolute risk” of the device type has not been established (i.e., initial questions of safety and effectiveness have not been resolved). That is, FDA is unsure whether the device type can be safe and effective. Category B: Non-experimental/Investigational – device types believed to be in classes I or II or device types believed to be in class III where the incremental risk is the primary risk in question (i.e., underlying questions of safety and effectiveness of that device type have been resolved), or it is known that the device type can be safe and effective because, for example, other manufacturers have obtained FDA approval for that device type.

Category B claims may be covered by Medicare during an IDE clinical trial if applied for. This is a pre-determination process (not to be confused with a pre-authorization process for private insurers) completed prior to the beginning of any clinical trial initiation. Medicare will review the expected services and/or procedures for medical necessity after submission of the proper paperwork from the provider of service. If approved, Medicare will issue an “IDE number” for use on claims, allowing the claims processor to know that this is an approved clinical trial.

Coding for clinical trials is completed according to routine coding convention in that coders use the CPT code that describes the services being provided. In the absence of a CPT code that defines the service, coders may need to use an unlisted code, describing the procedure performed, as well as submitting clinical documentation with the claim. In some cases, there may be a CPT Category III code. Category III codes are used for tracking purposes and generally have no payment value assignment. Per coding convention, if there is a Category III code available that describes the service performed, it should be used instead of the body area-appropriate unlisted code. An example would be a clinical trail for a hemilaminectomy with insertion of an interspinous process device (ISPD). The hemilaminectomy would be coded 63030 – Laminotomy (hemilaminectomy), with decompression of nerve root(s), including partial facetectomy, foraminotomy and/or excision of herniated intervertebral disc, including open and endoscopically-assisted procedure, one interspace, lumbar, while the insertion of the ISPD would be 0171T – Insertion of posterior spinous process distraction device (including necessary removal or bone or ligament for insertion with image guidance), lumbar, single level.. If using a Category III code, coders will want to submit procedural documentation with the claim.

There are specific modifiers for use in clinical trials. Modifiers are a combination of two numbers and/or letters that inform the claim examiner that there is something different about this particular service or procedure. For clinical trials, there is modifier “Q1” indicating “routine” services during clinical trial, and “Q0” indicating the “investigational” portion of the trial. Again, using the example above, 63030 would be submitted with modifier Q1, while Q0 would be attached to 0171T letting the carriers know that this is the investigational portion. Another modifier used with clinical trials is “FB” and this indicates that an item or service is donated to the physician and/or facility at no cost to the provider.

When providing diagnostic coding for clinical trail claims, the provider would use the same ICD-9-CM coding, routinely used for procedures or services, with the exception of the addition of ICD-9-CM code “V70.7” indicating participation in a clinical trail. For Medicare claims, V70.0 is required to be the secondary diagnosis, while the primary diagnosis would be the main reason for the service. An example for diagnostic use is 427.31 – atrial fibrillation, with V70.7 as the secondary diagnosis, and any other applicable diagnoses following after these. Providers will need to review commercial carrier guidance for placement of the V70.7 code specific to each plan.

This is a very brief overview of coding for clinical trials. It is a good idea to review clinical trial coverage for each major carrier, abiding by their individual guidance. There is much variation in coverage of clinical trials. While Medicare may cover a certain trial, other carriers may elect non-coverage of the entire trial, and others may reimburse for routine services, but not the experimental or “trial” portion. When patients have a Medicare Managed Choice (MMC) plan, it is important to note, claims should be submitted to Medicare for clinical trail services, and not the MMC. Providers will have a chance to review and/or negotiate any additional reimbursement by the clinical trail sponsor prior to any trail services being performed. There is specific guidance for government claims and sponsors are limited in what they can provide/ reimburse.

As with any new coding situation, coders will want to review the coding options for any clinical trial, review all guidelines for coverage by carriers, and know their clinical trial contracting well. Clinical trial coding does not have to be an “experiment,” especially when it affects your reimbursement.

1 http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080302.htm
2 http://www.cms.hss.gov/manuals/downloads/clm104c32.pdf Section 60 Investigational Device Exemption
3 2010 CPT, Professional Edition, AMA 2009
* 2010 ICD-9-CM for Hospitals, Volumes 1,2 and 3, 2009

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