Clinical trials and related routine services
Security Health Plan follows ForwardHealth guidelines for our Medicaid Managed Care Program.
Wisconsin Department of Health Services (DHS) defines a qualifying clinical trial as any trial in any clinical phase of development that is conducted in relation to the prevention, detection or treatment of any serious or life-threatening disease or condition. See ForwardHealth Topic 23037 ‘Qualifying Clinical Trials’ for more information on qualifying clinical trials. See the Hospital, Outpatient or Hospital, Inpatient Handbooks at www.forwardhealth.wi.gov/WIPortal/ .
- Under “Policy and Communication”, click on "Online Handbooks"
- Click “I Accept” and submit agreement
- Under “Program”, select “BadgerCare Plus & Medicaid”
- Under “Service Area”, select “Hospital, Outpatient” or “Hospital, Inpatient”
- Under “View Sections and Chapters”, expand “Covered and Noncovered Services”
- Select “Covered Services and Requirements”
- Select “Qualifying Clinical Trials”
Covered services
Per the 2024 HMO Contract and ForwardHealth update “2023-31 Clinical Trial Coverage Information” effective for dates of service on and after January 1, 2022, ForwardHealth covers routine services for members participating in qualifying clinical trials.
For the definition of qualifying clinical trials, please see the ForwardHealth update.
Routine services include the following:
- Any item or service provided to members participating in a qualifying clinical trial that would otherwise be covered by ForwardHealth (such as otherwise-covered physician, laboratory or medical imaging services).
- Any item or service required solely for the provision of the investigational item or service that is the subject of the qualifying clinical trial (such as administration of the investigational item or service and routine services for the delivery of experimental agents).
Covered items and services must:
- Prevent, diagnose, monitor or treat complications resulting from participation in the qualifying clinical trial.
- Be covered outside of participation in the qualifying clinical trial.
Attestation of Appropriateness of Clinical Trial:
In order to cover routine services associated with a clinical trial, ForwardHealth requires providers to attest to the appropriateness of the qualifying clinical trial. To meet this requirement, the provider and the principal investigator must complete and maintain the CMS attestation form in the member’s health care records. This form must be submitted with all prior authorization requests for routine services related to a clinical trial.
Non-covered services
Examples of items and services not covered by ForwardHealth as part of a qualifying clinical trial include the following:
- Any investigational item or service that is the subject of the qualifying clinical trial and is not otherwise covered by ForwardHealth outside of the clinical trial.
- Any item or service that is provided to the member solely to satisfy data collection and analysis for the qualifying clinical trial that is not used in the direct clinical management of the member and is not otherwise covered by ForwardHealth outside of the clinical trial.
Prior authorization
In accordance with ForwardHealth guidelines & the HMO Contract, Security Health Plan may require prior authorization for coverage of certain procedures or services associated with a clinical trial.
- If the service would require prior authorization if performed when it is unrelated to a clinical trial, it also requires prior authorization if performed in association with the clinical trial (example: MRI).
- For information on services that require prior authorization, view the Security Health Plan Medical Policies at: www.securityhealth.org/providers/medical-policies
To ensure your request is handled appropriately, please confirm the following information is included:
- Mark all prior authorization requests for routine services related to clinical trials as “Urgent/Expedited”
- CMS Attestation Form
- Diagnosis Z00.6 - Encounter for examination for normal comparison and control in clinical research program
- Services being requested (CPT/HCPCS) with modifier ‘Q1’