Processing Claims for Clinical Trial Routine Care Services

Revised Guidelines

Sept. 26, 2001

NHIC (California Medicare) recently received change request (CR) 1637, which clarifies processing of claims for qualifying clinical trial services. NHIC will implement these changes effective January 1, 2002.

Diagnosis Reporting Requirements for Services Billed on the CMS-1500 Form or Electronically:

Effective for services furnished on or after January 1, 2002, CMS-1500 form or electronic billers will use procedure code modifier "QV" to identify and report routine care for Medicare qualifying clinical trial services. Reporting diagnosis code V70.5 as a secondary diagnosis on the CMS-1500 form or on electronic claims will no longer be required for dates of service on or after January 1, 2002. For dates of service on or after January 1, 2002, the QV modifier constitutes the billers attestation that a service, supply or equipment meets the Medicare qualifying coverage criteria for clinical trial services processed by carriers and DMERCS.

Exception: Routine care clinical trial services rendered on or after January 1, 2002 to healthy, control group volunteers participating in Medicare qualifying diagnostic clinical trials are to be coded and billed in the following manner:

Report the "QV" procedure code modifier at the line item level.

Report diagnosis code V70.7 (Examination of participant in clinical trial) as the primary diagnosis for applicable line items on the CMS-1500 or electronic claim equivalent. If diagnosis code V70.7 is reported as secondary rather than as the primary diagnosis, then do not consider the service as having been furnished to a healthy, control group, diagnostic trial volunteer.

Documentation Requirements:

When submitting claims for routine items and services furnished in qualifying clinical trials, the billing provider should include information in the beneficiary’s medical record about the clinical trial such as: the trial name, sponsor and sponsor assigned protocol number. This information should not be submitted with the claim but should be provided if requested for medical review. A copy of routine items and services should also be made available if requested for medical review activities.

Clinical Trials

Medicare will soon provide limited coverage of the medical costs associated with clinical trials.

The actual item or service under investigation will still be non-covered

Ancillary services and care will be considered covered

More info available at: http://www.cms.gov/coverage/8d.asp

Clinical Trials

Effective for items and services furnished on or after September 19, 2000, Medicare covers the routine costs of qualifying clinical trials, as such costs are defined below, as well as reasonable and necessary items and services used to diagnose and treat complications arising from participation in all clinical trials. All other Medicare rules apply.

Routine costs of a clinical trial include all items and services that are otherwise generally available to Medicare beneficiaries (i.e., there exists a benefit category, it is not statutorily excluded, and there is not a national noncoverage decision) that are provided in either the experimental or the control arms of a clinical trial except:

• the investigational item or service, itself,
• items and services provided solely to satisfy data collection and analysis needs and 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); and
• items and services customarily provided by the research sponsors free of charge for any enrollee in the trial. Routine costs in clinical trials include:
• Items or services that are typically provided absent a clinical trial (e.g., conventional care);
• Items or services required solely for the provision of the investigational item or service (e.g., administration of a noncovered chemotherapeutic agent), the clinically appropriate monitoring of the effects of the item or service, or the prevention of complications; and
• Items or services needed for reasonable and necessary care arising from the provision of an investigational item or service--in particular, for the diagnosis or treatment of complications.
• The decision, memo and other information can be found at http://www.cms.gov/coverage/8d.asp