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The following is important for all clinical researchers to understand the new National Coverage Decision. I would
especially like to point out the answers below in regard to Category B devices and the answer about screening. This is
different from how we had previously interpreted the regulations. They are specifically saying we cannot bill for the
device and not all studies using a category B device will be covered (see Clinical Research newsletter). We will try
to get clarification on this because it seems to contradict the regulation about Category B devices, but this is
HCFA's current position and we will need to adapt to it.
-Leon Goldman
HCFA Answers to National Coverage Decision (NCD) Questions
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Do services that would be required anyway because of a patient's underlying disease need to be coded with the new modifier?
Yes. Provider's who bill using the HCFA-1500 must identify any services that are part of a qualifying clinical trial with the new QV modifier and report diagnosis code V70.5 as other than the primary diagnosis. The modifier serves as the provider's attestation that the service meets the Medicare qualifying clinical trial coverage criteria and can be paid. Providers who bill via the UB-92 are to identify clinical trial services by entering the V70.5 diagnosis code (as other than the primary diagnosis) on the claim.
Can providers bill for routine monitoring of patients enrolled in clinical trials?
Providers can bill for the routine monitoring of patients only if the item or service is used in the direct clinical management of the patient and is not performed solely for purposes of data collection.
Will Medicare cover screening of patients to see if they qualify to be enrolled in a clinical trial?
No. Items and services used solely to determine patient eligibility
for a enrollment in a clinical trial will not be covered by Medicare.
Do the operational issues imposed by the intermediaries with respect to the IDE rule still stand? What is the process for submitting those claims now - do we include the new modifier on the claim?
Yes. The policies about coverage and payment for IDE devices are established by regulation. This regulation supercedes national coverage decisions. Therefore, category A IDE devices and their related costs are noncovered by Medicare. Coverage of category B IDE devices remains at contractor discretion. A category B IDE trial may receive coverage under the national coverage decision on clinical trials only if it falls into one of the category of trials automatically qualified under the policy or meets the qualifying criteria (once the self-certification process is established). Coverage under this policy does not allow coverage of the investigational device itself.
Please define "control arm" of a clinical trial. Are placebo-controlled clinical trials included in the Medicare Clinical Trials Coverage Policy?
The control arm of a therapeutic clinical trial is the research arm of the trial that does not receive the investigational item or service being studied. The control arm of a diagnostic trial typically receive the investigational diagnostic test to determine the accuracy of the test (determine the false negative and the false positive rates). Placebo-controlled clinical trials are included in the policy, provided they meet the requirements listed in the national coverage decision on clinical trials.
Does coverage of clinical trials by Medicaid continue to remain a state by state decision?
Yes. The clinical trials policy is a Medicare coverage policy. It does not directly impact Medicaid policy.
Can we have examples of covered and non-covered services?
An example of a non-covered item of service would be the investigational item or service. Items and services that are required solely to meet data collection needs would also be non-covered. For example, in a trial where patients were are given daily CT scans when the clinical management of their disease only requires weekly CT scans, only the weekly CT scan would be covered. The other six CT scans would not be covered.
Are services that are non-covered by reason of a national non-coverage decision covered if the service is the focus of a clinical trial?
No. Nationally non-covered services remain non-covered whether they are the focus of a qualifying trial or performed as part of the routine care associated with a qualifying trial.
Additionally, if the devices used in the trial are Category B devices would the entire admission, including the device, be covered? Would such admissions properly coded with the V70.5 code be paid at the rate of the medical DRG or the surgical DRG for the implantation of the device which is the focus of the trial, but the object of the national coverage decision?
If the category B IDE device is covered according to the IDE regulations, the clinical trials modifier and V-code should not appear on the claim. However, if coverage of the routine costs associated with the category B IDE device occurs because of the clinical trials national coverage policy, then the QV modifier and the V70.5 ICD-9 code need to appear on the claim according to the billing instructions found at http://www.hcfa.gov/coverage/8d.htm. The payment amount will depend upon what the routine care services actually are. We cannot say with certainty that a surgical DRG or a medical DRG will always be paid.
Is there a projected timeframe for the designated committee to complete guidelines so that trials may be self-certified?
There is no projected timeframe for the multi-agency panel to finalize its recommendations on the qualifying criteria. Because the multi-agency panel has been working quickly, we expect to receive the qualifying criteria very shortly. HCFA hopes to have the self-certification process and the clinical trials registry implemented later this year. Interested parties should monitor our website for updates at www.hcfa.gov/coverage.
How should providers code a service that is needed for the trial (e.g., an EKG) but is also needed for appropriate management of a patient's condition?
Items and services that are necessary for the clinically appropriate management of the patient's condition in a qualified clinical trial will be covered as routine care. Providers who bill via the HCFA-1500 should code such costs with the new QV modifier and with a secondary diagnosis code of V70.5. Providers who bill via the UB-92 would bill these items and services by entering the diagnosis code V70.5 (as other than the primary diagnosis) on the claim.
In the claims processing instructions that were provided to Medicare contractors, it states that providers should enter clinical trial and non-clinical trial services on separate line items when billing both types of services on the same claim. However, outpatient services identified with HCPCS are already submitted on separate line
items. Since modifiers are not required with HCPCS on claims submitted to intermediaries, what is the relevance of the instruction as it still wouldn't be possible to know which line item is a clinical trial item and which is not?
For providers who bill using the UB-92, we agree that there is currently no need to submit separate line items for identical clinical trial and non-clinical trial items and services since the entire claim is processed as a clinical trial claim when the V70.5 diagnosis code is submitted (as other than the primary diagnosis).
Please provide a listing of items and services that are newly covered as a result of this NCD?
There is no list of every routine item or service that is covered under this policy. The items and services covered under this policy must have a Medicare benefit category, not be statutorily excluded, and not be the subject of a national noncoverage policy.
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