• The study or investigation is conducted under an Investigational new drug application reviewed by the U.S. Food and Drug Administration; • The study or investigation is a drug trial that is exempt from having such an Investigational new drug application; • The clinical trial must have a written protocol that describes a scientifically sound study and have been approved by all relevant Institutional Review Boards (IRBs) before participants are enrolled in the trial. The Plan Sponsor may, at any time, request documentation about the trial; or • The subject or purpose of the trial must be the evaluation of an item or service that meets the definition of a covered health service and is not otherwise excluded under the Plan. 59. Radiation Therapy and Chemotherapy when Medically Necessary. 60. Radiology and Interpretation Charges. 61. Reconstructive Surgery includes: • Surgery following a mastectomy under the Women’s Health and Cancer Rights Act (WHCRA). Under the WHCRA, the Covered Person must be receiving benefits in connection with a mastectomy in order to receive benefits for reconstructive treatments. Covered Expenses are reconstructive treatments that include all stages of reconstruction of the breast on which the mastectomy was performed; surgery and reconstruction of the other breast to produce a symmetrical appearance; and prostheses and complications of mastectomies, including lymphedemas. • Surgery to restore a bodily function that has been impaired by a congenital Illness or anomaly, or by an Accident, or from an infection or other disease of the involved part. 62. Respiratory Therapy. (See Therapy Services below.) 63. Second Surgical Opinion if given by a board-certified Specialist in the medical field related to the surgical procedure being proposed. The Physician providing the second opinion must not be affiliated in any way with the Physician who rendered the first opinion. 64. Sexual Function: Diagnostic Services in connection with treatment for male or female impotence. 65. Sleep Disorders if Medically Necessary. 66. Sleep Studies. 67. Speech Therapy. (See Therapy Services below.) 68. Sterilizations. 69. Substance Use Disorder Services. (Refer to the Substance Use Disorder and Chemical Dependency Benefits section of this SPD.) 70. Surgery and Assistant Surgeon Services. • If an assistant surgeon is required, the assistant surgeon’s covered charge will not exceed 20% of the allowance for the primary procedure performed. For in-network providers, the assistant surgeon’s allowable amount will be determined per the network contract. • If bilateral or multiple surgical procedures are performed by one surgeon, benefits will be determined based on the allowance for the primary procedure; and a percentage of the allowance for the subsequent procedure(s). If multiple unrelated surgical procedures are performed by two or more surgeons on separate operative fields, benefits will be based on the allowance for each surgeon’s primary procedure. If two or more surgeons perform a procedure that is normally performed by one surgeon, benefits for all surgeons will not exceed the allowable amount for that procedure. -66- 7670-00-413597