Neurology & Pain Management Coding Alert

Clinical trials are important in the development of new treatments and medications and neurologists can tap into research and grant money for the development of these important studies. Funding for the clinical care given to the subjects of such trials, however, is a different matter. Effective Sept. 19, 2000, and updated and clarified on June 4, 2001, the Centers for Medicare and Medicaid (CMS, formerly HCFA) released guidelines, called the National Coverage Determination (NCD), outlining Medicare coverage of such clinical trials. According to this directive, Medicare covers:
 

the routine costs of qualifying clinical trials; and
 

reasonable and necessary items and services used to diagnose and treat complications arising from participation in all clinical trials.

 
It is important for billing personnel to be aware that not only the routine costs directly involved, but also those incurred as a result of diagnosing or treating complications resulting from a clinical trial are reimbursable under Medicare guidelines. As Carol Pohlig, RN, CPC, a reimbursement analyst for the Office of Clinical Documentation at the University of Pennsylvania, explains, "This directive allows practices to bill and be reimbursed more frequently for those services provided to diagnose and treat complications associated with clinical trials. Even though these reimbursements were possible prior to Sept. 19, 2000, the NCD's clarification lessens the scrutiny of such claims, resulting in fewer denials and, thus, the realization of more dollars."

 
The first step to ensure prompt and complete reimbursement involves making sure that the clinical trial meets the criteria established by Medicare. In order to qualify, it must meet all of the following:
 

The drug or procedure being studied must fall within a benefit category as defined by Medicare.
 

The intent of the trial must be therapeutic; it cannot be designed to test for toxicity or disease pathology only.
 

The subjects used in the trials can be of two kinds:  trials of therapeutic intervention must use patients diagnosed with the appropriate disease, not healthy volunteers, while trials of diagnostic intervention may use healthy patients as a control group.
 
The trial must have the following characteristics, deemed desirable by the NCD:
 

It has the potential to improve the health of the participants.
 

It is supported by current medical and scientific information, or it clarifies or explains clinical practices currently in use.
 

It does not duplicate previous trials.
 

It is designed to answer the research questions posed.
 

It is sponsored by an organization or individual appropriately able to do so.
 

It complies with federal regulations.
 

It is conducted scientific accuracy and integrity.

 
The NCD directive clarifies this point by indicating that trials funded by the National Institutes of Health (NIH), the Centers for Disease Control and Prevention (CDC), the Agency for Healthcare Research and Quality (AHRQ), the Department of Defense (DOD), and the Department of Veterans Affairs (VA) as well as FDA-sponsored trials conducted under an "investigational new drug application" are "automatically deemed" as fulfilling the necessary criteria.

 
The next step to ensure prompt and complete reimbursement is to define what is a routine cost of a clinical trial and, therefore, covered by Medicare. In general, all items, procedures, and services provided to  the experimental and control groups are covered. Specifically, CMS defines the following as routine and reimbursable costs: 
 

Services and procedures typically provided for normal healthcare.
 

Services and procedures called for by the trial, for example, the administration of an agent, such as a chemotherapeutic agent, not covered by Medicare.
 

Services and procedures needed to monitor the trial or to prevent complications.
 

Services and procedures needed to diagnose and treat complications as a result of the trial.

 
However, some costs are not covered by Medicare.  Below is a list of those that are not routine:
 

The drug or procedure being investigated.
 

Services that are excluded or not covered by Medicare.
 

Procedures used for collection of data only and not for care of the patient, for example, multiple CAT scans for a condition requiring only one.
 

Services and procedures usually provided free of charge to volunteers in the trial.
 

Services and procedures used to determine patient eligibility for the trial.

 
CMS recommends that practices ascertain that a clinical trial and the costs incurred fit these guidelines before submitting a claim. In addition, appropriate supporting evidence should be placed in the medical records of patients participating in such qualifying trials.
 
There is no special form to be used to bill for clinical trial services. You should continue to use the HCFA 1500 form or the electronic equivalent. To ensure reimburse-ment, the principal diagnosis should be coded using the proper ICD-9 code. Added to this is the appropriate V code indicating that the patient is a participant in a clinical trial and receiving care. The V70.5  (health examination of defined subpopulations) is used as the secondary diagnosis code. Then, the procedure performed or service given is coded using the appropriate CPT code appended with the the -QV modifier (item or service provided as routine care in a Medicare covered clinical trial) used to identify the clinical trial services. Since the -QV modifier is line specific, it can be used as many times as necessary on any given claim. Thus, a practice can code as many services and procedures as administered to a patient, adding the -QV modifier to each. 
 
Ensuring Reimbursement
     
 
If a claim is denied, a practice should make sure that the clinical trial has been substantiated as acceptable for Medicare coverage. Then the -QV modifier and the V code should be checked to make sure that they have been appropriately used. If all this paperwork is correct and the claim is still denied, CMS recommends contacting the carrier to explain that this service was part of a clinical trial and should have been reimbursed.
  
Documentation is important for prompt and complete reimbursement. Even though the NCD makes this process easier, the appropriate paperwork is still needed. The patient's medical record needs to contain the trial name, its sponsor, and the protocol number. Although this information does not need to be submitted with the claim, it should be available if requested. In addition, the patient's consent form and documentation attesting to the fact that the clinical trial meets the criteria outlined by Medicare also must be readily available.