39 Clinical Trials Charges made for routine patient costs associated with approved clinical trials are covered medical charges under the terms of the Plan. An approved clinical trial is a phase I, phase II, phase III, or phase IV clinical trial that is conducted in relation to the prevention, detection, or treatment of cancer or other life - threatening disease or condition. An individual wil l qualify for participation in an approved clinical trial based on a referral from a physician or an Allied Health Professional participating in the trial, or by providing medical and scientific information establishing that participation would be appropri ate. Routine patient costs include all items and services consistent with the coverage provided under the Plan for a person not enrolled in a clinical trial. Routine patient costs do not include, and reimburs ement will not be provided for: • The investigat ional item, device or service; • Services or supplies listed as Exclusions; • Services or supplies related to data collection for the clinical trial (i.e., protocol - induced costs); • Services that are clearly inconsistent with widely accepted and established standards of care for a particular diagnosis; or • Services or supplies, which in the absence of private health care coverage, are provided by a clinical trial sponsor or other party (e.g., device, drug, item or service supplied by manufacturer and not yet FDA approved) without charge to the trial participant. Erectile Dysfunction Charges for the treatment of erectile dysfunction are covered medical charges. Benefits are limited to physician or Allied Health Professional charges for diagnostic services to de termine the cause of the erectile dysfunction, and charges for internal penile implants or external devices for an erectile dysfunction that is clearly caused by an established medical condition, such as postoperative prostatectomy or diabetes. Penile impl ants and external devices are not covered to treat psychogenic erectile dysfunction. Refer to the terms of Prescription Drug Coverage for more information on coverage of, and limitations on male androgens used to treat erectile dysfunction. Genetic Testing Charges for genetic testing that uses a proven testing method for the identification of a genetically linked inheritable illness are covered medical charges, but only if one of the following requirements is met: • The covered individual has symptoms or sign s of a genetically linked inheritable illness; • It has been determined that the covered individual is at risk for carrier status as supported by existing peer - reviewed, evidence - based, scientific literature for the development of a genetically linked inheri table illness when the results will impact clinical outcome; or • The therapeutic purpose is to identify specific genetic mutation that has been demonstrated in the existing peer - reviewed, evidence - based, scientific literature to directly impact treatment op tions. Home Health Care The following charges for Home Health Care services are covered medical charges. The Plan will not pay for Home Health Care unless: • A plan of Home Health Care is drawn up, or approved, by the covered individual’s physician or Allied Health Professional; and