Advanced Search

Pulmonology Coding Alert

New Guidelines for Clinical Trial Reimbursement

Published on Wed Aug 01, 2001

Clinical trials are important in the development of new treatments and medications for asthma, emphysema and other respiratory conditions, and pulmonologists can tap into research and grant money for the development of these important studies. But funding for the clinical care given to the subjects of such trials is a different matter. Effective Sept. 19, 2000, and updated and clarified on June 4, 2001, the Centers for Medicare & Medicaid Services (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.
    •  
    The routine costs directly involved and those incurred as a result of diagnosing or treating complications resulting from a clinical trial are reimbursable under Medicare guidelines. Carol Pohlig, RN, CPC, a reimbursement analyst for the office of clinical documentation at the University of Pennsylvania, says, "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."

    Meet the Established Criteria
     
    The first step to ensure prompt and complete reimbursement is to make sure the clinical trial meets the criteria established by Medicare. 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 with scientific accuracy and integrity.
    •  
    Walter O'Donohue Jr., MD, FCCP, FACP, a representative to the AMA CPT Advisory Committee for the American College of Chest Physicians (ACCP) and CRT/RUC committee chairman of the ACCP, explains that meeting all of these criteria is difficult because CMS is very strict in its classification of these clinical trials.
     
    The NCD directive clarifies this point by indicating that trials funded by the National Institutes of Health, the Centers for Disease Control and Prevention, the Agency for Healthcare Research and Quality, the Department of Defense and the Department of Veterans Affairs, as well as FDA-sponsored trials conducted under an "investigational new drug application," are "automatically deemed" as fulfilling the necessary criteria.

    Reimbursable and Nonreimbursable Costs
     
    The next step to ensure prompt and complete reimbursement is to define what is a routine cost of a clinical trial and, therefore, what is 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.
    •  
    But some costs are not covered by Medicare. These 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 scan
     
  • 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. And appropriate supporting evidence should be placed in the medical records of patients participating in such qualifying trials.
     
    There is no special form for billing clinical trial services, so continue to use the HCFA 1500 form or the electronic equivalent. To ensure reimbursement, 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. 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 -QV modifier (item or service provided as routine care in a Medicare-qualifying clinical trial) to identify the clinical-trial services. Since the -QV modifier is line-specific, it can be used as often 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. 
     
    Coding Clinical Trials
    •  
    For example, a 55-year-old male suffering from emphysema (492) is a participant in an accepted clinical trial testing a new bronchodilator. He presents to the pulmonologist for a routine exam required by the study and undergoes a bronchospasm evaluation both before and after being administered the bronchodilator being tested. On the HFCA 1500, this visit would be coded with 492 to indicate the emphysema, V70.5 to indicate that the patient is part of a clinical trial, and 94060 (bronchospasm evaluation: spirometry as in 94010, before and after bronchodilator [aerosol or parenteral]) with the -QV modifier attached to indicate that the bronchospasm evaluation fits the Medicare definition of routine care in an accepted clinical trial and should be reimbursed as such.
     
    To ensure adequate data, the clinical trial stipulates that the participants, like the 55-year-old emphysema patient, must return to the pulmonologist for subsequent bronchospasm evaluations 24 and 48 hours after the administration of the new drug. However, because the purpose of these last two evaluations is solely data collection and is not related to any care needs or symptoms generated by the patient or the disease, the second and third bronchospasms would not meet the definition of "routine" care as required by Medicare and are not reimbursable.
     
    After one of the treatments with the bronchodilator being studied, the same emphysema patient clinically diagnosed with hypertension suffers a hypertensive episode resulting in hospitalization. This situation would be coded:
     
  • 401.0-401.9 (essential hypertension, malignant, benign, or unspecified)
        
  • 492
       
  • V70.5
       
  • 99221-99223 (initial hospital care) 
      
  • -QV attached to 99221-99223
     
    These codes account for the E/M of a patient depending on the level of complexity of the interval history taken, the problem-focused examination given and the medical decision-making rendered. If the patient requires subsequent days of hospital care by a pulmonologist, each day of service would be coded using the appropriate 99231-99233 code, depending on the complexity of care, with the -QV modifier attached to each. Thus, five additional days of hospitalization requiring detailed and complex medical care would be coded 99233-QV x 5. 
     
    Pohlig notes that this type of situation is the one most affected by the new NCD directive. Prior to Sept. 19, 2000, the pulmonologist had to identify the cause of the hypertension very carefully, proving that it was not related to the drug being tested. That distinction is no longer necessary, and the reason for the hypertensive episode is no longer scrutinized by CMS because the directive indicates that complications caused by clinical trials are reimbursable.
     
    If a claim is denied, a practice should make sure 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 they have been used appropriately. If all of 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 need not be submitted with the claim, it should be available if requested. And the patient's consent form and documentation showing that the clinical trial meets the criteria outlined by Medicare must also be readily available.

    • Other Articles in this issue of

    Pulmonology Coding Alert

    View All