Clinical Trial Provision*

Medical Policy: 10.01.01 
Original Effective Date: September 1998 
Reviewed: February 2008 
Revised: June 2001 

This policy applies to all products unless specific contract limitations, exclusions or exceptions apply. Please refer to the member's coverage manual for benefit availability. Managed care guidelines related to referral authorization, and precertification of inpatient hospitalization, home health, home infusion and hospice services apply.

Description: 

For certain illnesses, care through a clinical trial may be the only hope for a cure. The purpose of this policy is to identify patient selection criteria and a defined category of approved clinical trials in which qualified members may be eligible to enroll. Prior approval is recommended  and the Plan's Medical Director will review all requests.

Prior approval is recommended. Submit a prior approval now. 

Policy: 

• Patient has a life-threatening or serious illness for which no standard treatment is effective;
• Patient has been determined to meet the protocol of the clinical trial in question; and 
• Medical documentation provided by the referring physician establishes a reasonable potential for clinical benefit for the patient.

An "approved clinical trial" means a research study or clinical investigation approved and funded (which may include funding through in-kind contributions) by one or more of the following:

• The National Institutes of Health;
• A cooperative group or center of the National Institutes of Health, such as the National Cancer Institute (NCI), the National Institute of Neurological Disorders and Stroke (NINDS), the National Institute of Allergy and Infectious Disease (NIAID), and others;
• The Department of Veteran's Affairs; or 
• The Department of Defense.

Providers/vendors should submit a copy of the written proposal for clinical trial.

Upon approval by the Medical Director the following benefits may be available:

• Routine patient costs for items and services furnished in connection with participation in the trial; and 
• Medically necessary standard treatment provided in the setting of the clinical trial required of the patient independent of trial participation. 

Benefits are not available for the following in association with an approved clinical trial:

• Costs of tests or measurements conducted primarily for the purpose of the clinical trial; and
• Costs associated with research trials not meeting the definition of an approved clinical trial, as described above.

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Procedure Codes and Billing Guidelines: 

To report provider services, use appropriate CPT** codes, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or ICD-9 diagnostic codes.

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Selected References: 

• Medical Director's, Wellmark Blue Cross Blue Shield.

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Wellmark Blue Cross and Blue Shield
Medical Policy Analyst
Station 304
636 Grand Ave.
Des Moines, IA 50309

*Prior approval is recommended for this policy.

**Current Procedural Terminology © 2008 American Medical Association. All Rights Reserved.

Wellmark medical policies address the complex issue of technology assessment of new and emerging treatments, devices, drugs, etc.   They are developed to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. Wellmark medical policies contain only a partial, general description of plan or program benefits and do not constitute a contract. Wellmark does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Wellmark or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. Our medical policies may be updated and therefore are subject to change without notice.