This version of the policy will become effective 01/01/2014.
The policy was amended to conform to the “Coverage for Individuals Participating in Approved Clinical Trials” requirements of the Patient Protection and the Affordable Care Act (ACA).
In addition to the ACA changes, the requirement related to the completion of the Physician's Certificate of Attestation has been deleted from the policy.
The following text has been deleted from the Noncovered Services section of the policy:
· Routine costs associated with clinical trials that do not have a therapeutic intent are not considered routine and are not covered or eligible for reimbursement consideration by the Company.
Time and Event schedule or approved study budget were added to the Required Documentation section as examples of specific routine items and services provided to the individual.
A copy of the signed and dated study-specific Informed Consent Form was also added to the list of Required Documentation.
ICD-10-CM codes were added based on GEMS mapping converting current ICD-9-CM codes to applicable ICD-10-CM codes, and clinically reviewed considering the scope and intent of the policy document and the appropriateness of the codes for the policy. ICD-10-CM codes will be in effect on the determined ICD-10 compliance date. However, they are being added to policy for informational purposes only.
For the current version of this policy, click the following link: 07.00.20d Routine Costs Associated with Qualifying Clinical Trials
In products where members are able to self-refer to providers for care and services, members are advised to use participating providers in order to receive the highest level of benefits.When services can be administered in various settings, the Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition. This decision is based on the member’s current medical condition and any required monitoring or additional services that may coincide with the delivery of this service.
For more information on how Claim Payment Policy Bulletins are developed, go to the About This Site section of this Medical Policy Web site.
Z00.6 Encounter for examination for normal comparison and control in clinical research program
THE FOLLOWING MODIFIER MUST BE REPORTED WITH EACH CPT/HCPCS THAT REPRESENTS A ROUTINE COST ASSOCIATED WITH A QUALIFYING CLINICAL TRIAL:
Q1 Routine clinical service provided in a clinical research study that is in an approved clinical research study