Oncology & Hematology Coding Alert

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 same claim.

When submitting claims with the -QV modifier and V70.5 diagnosis code, the provider must include in the beneficiarys medical record the following information: trial name, sponsor and sponsor-assigned protocol number. This information should not be submitted with the claim but must be provided if requested for medical review. A copy of the signed informed-consent document must also be available if requested for medical review.

The following list offers guidance and suggestions for this new Medicare payment policy:

Be sure the providers in your practice are aware of this new coverage policy.

Work with your clinical-trials staff to identify patients on Medicare-eligible trials for your billing staff. Flag these patients in your practice management system or set up other systems to ensure that appropriate modifiers and diagnosis codes are used.

Appeal all denials. Some carrier education may be necessary as everyone works to implement this new coverage policy appropriately