Reader Question:
Clinical Trial Reimbursement
Published on Tue May 01, 2001
Question: What are the new Medicare guidelines regarding patients on clinical trials?
Virginia Subscriber
Answer: Effective for services rendered on and after Sept. 19, 2000, HCFA implemented a new policy to cover routine costs in clinical trials. This national coverage policy is binding on all Medicare carriers, intermediaries, peer-review organizations, health maintenance organizations, competitive medical plans, healthcare prepayment plans, and Medicare-managed organizations. According to HCFAs National Coverage Determination (NCD) which can be accessed and downloaded from www.hcfa.gov/quality/8d.htm 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.
Routine costs are generally considered part of the direct clinical management of the patients. They include items or services that are:
Typically provided absent a clinical trial, such as medically necessary conventional care;
Required for the provision of the investigational item or service, such as the administration of a non-covered chemotherapeutic agent;
Necessary for the clinically appropriate monitoring of the effects of the item or service, or the prevention of complications; and
Medically necessary for the diagnosis or treatment of complications arising from the provision of an investigational item or service.
Medicare, however, does not include:
The investigational item or service itself;
Items and services for which there is no Medicare benefit category or which are statutorily excluded or that fall under a national noncoverage policy;
Items and services furnished solely to satisfy data collection and analysis needs that are not used in the direct clinical management of the patient (e.g., monthly CT scans for a condition usually requiring only a single scan);
Items and services customarily provided by the research sponsors free of charge for anyone enrolled in the trial; and
Items and services provided solely to determine trial eligibility.
When submitting claims for services or items that meet the requirements as outlined in the final NCD, you must identify these services with modifier -QV (item or service provided as routine care in a Medicare qualifying clinical trial). The modifier is line-item- specific. It must be used to identify items and services that constitute medically necessary routine care, or treatment of complications arising from a Medicare beneficiarys participation in a covered trial.
In addition to modifier -QV, providers must also report diagnosis code V70.5 (health examination of defined subpopulations) as a secondary diagnosis for patients participating in Medicare-covered clinical trials. According to HCFA, modifier -QV and V70.5 will prove that the service meets the Medicare coverage criteria.
Oncology practices should submit separate line items for clinical-trial services when billing other covered services not directly related to a Medicare qualifying clinical trial on the [...]
