Humana's Your Practice

Clinical Trials, Category B Investigational Device Exemptions (IDEs) and Medicare Studies

Humana uses the Centers for Medicare & Medicaid Services (CMS) reporting guidelines to identify charges related to clinical trials, Category B IDEs and Medicare studies. To facilitate correct processing of claims by the appropriate insurer, please follow the protocols listed below.

Clinical trials
According to the U.S. National Institutes of Health, a clinical trial is generally a biomedical or health-related research study in human beings that follows a predefined protocol.

For additional information on the clinical trial registry, visit www.clinicaltrials.gov.

Where to file your clinical trial claim

For Medicare Enrollees: Clinical trial charges should be sent directly to the appropriate Medicare carrier or fiscal intermediary, not Humana.

For additional information on Medicare criteria for clinical trials, see National Coverage Determination (NCD) 310.1 on “Routine Costs in Clinical Trials” at http://www.cms.hhs.gov/mcd/index_list.asp?list_type=ncd#PC
For Commercial Enrollees: Clinical trial charges should be filed with Humana.

For additional information on Humana’s coverage of clinical trials, search under “Clinical Trials” in the “Coverage Issues” portion of our Web site at http://www.humana.com/providers/tools/provider_tools/clinical_healthcare.asp

Identify your clinical trial claim correctly by using the appropriate V70.7 diagnosis code, QV/Q1 modifier or Condition Code, and Registry Number (this field is optional). Codes are as follows:

Diagnosis Code V70.7, “Examination of participant in clinical trial.”

According to CMS, whether the V70.7 is placed in a primary or secondary position depends on the type of provider.

• Institutional providers should sequence the V70.7 as a secondary diagnosis.
• Professional providers should sequence the V70.7 as the primary diagnosis.

For additional information on clinical trial coding, see http://www.cms.hhs.gov/manuals/downloads/clm104c32.pdf

Q1 Modifier, “Routine clinical service provided in a clinical research study that is in an approved clinical research study.” Effective Jan. 1, 2008, CMS deleted the QV modifier and replaced it with Q1. The QV modifier should be used for dates of service prior to Jan. 1.

For additional information, see http://www.cms.hhs.gov/MLNMattersArticles/downloads/MM5805.pdf

Condition Code 30, “Qualifying Clinical Trials.”
If you’re billing on a CMS-1450, don’t forget your condition codes. According to CMS, condition code 30 is used to report “non-research services provided to all patients, including managed care enrollees in a qualified clinical trial.”

The 8-digit registry number is the number assigned by the National Library of Medicine (NLM) Clinical Trials Data Bank when a new study is registered by a sponsor or investigator. For additional information, please visit the following site: http://www.cms.hhs.gov/MLNMattersArticles/downloads/MM5790.pdf.

Category B IDEs
Medicare has had a long-standing policy to exclude from coverage items and/or services that are experimental or investigational in nature because their safety and efficacy has not been proven. However, in 1996, IDEs expanded coverage to allow certain medical devices and related procedures.

Where to file your Category B IDE claim

For Medicare and Commercial Enrollees: Clinical trial charges should be filed with Humana.

Don’t forget to identify your claim as a Category B IDE trial. Most are coded using a combination of the V70.7 diagnosis code, Q0/QA modifier and/or Revenue Code 0624.

Q0 Modifier, “Investigational clinical service provided in a clinical research study that is in an approved clinical research study.” Effective Jan. 1, 2008, CMS deleted the QA modifier and replaced it with Q0. The QA modifier should be used for dates of service prior to Jan 1.

For more information, see MLN Matters article MM5805: http://www.cms.hhs.gov/MLNMattersArticles/downloads/MM5805.pdf

Revenue Code 0624, “Investigational Device Exemption (IDE)”
For additional information on Category B IDE coding, see http://www.cms.hhs.gov/manuals/downloads/clm104c32.pdf

Medicare Studies
What about Positron Emission Tomography (PET)?
Medicare provides coverage for PET scans in three ways: 1) As a regular Medicare benefit for specific conditions, 2) in a clinical trial of fluorodeoxyglucose (FDG) PET that meets the requirements of a Food and Drug Administration (FDA) category B IDE and 3) in an FDG PET clinical study, aka: National Oncologic PET Registry (NOPR). To facilitate appropriate reimbursement, the primary diagnosis code should reflect the reason for the exam.

Where to file your PET scan claim

• For Medicare and Commercial Enrollees: Clinical trial charges should be filed with Humana.

How to report a PET scan claim
For PET scans performed as part of the NOPR, remember to include a Q0/QR modifier on all claim lines. However, don’t use the V70.7 diagnosis code. The NOPR is not a clinical trial, nor are there currently any Category B IDE trials surrounding PET scans. Claims billed with a V70.7 diagnosis will be recognized as a clinical trial claim and processed appropriately.