X hits on this document





89 / 113

provides 24-hour a day nursing service by a Registered Nurse (RN); and which is duly licensed as a hospital in such state. The term hospital may also include an institution that primarily provides psychiatric or chemical dependency care, if licensed as such by the state in which the hospital is located. Benefits are not provided for treatment in a facility that is primarily a place for rest, rehabilitation, or the aged, including custodial and convalescent, except as otherwise provided by the Plan.

Illness: an accidental injury, a bodily or mental disorder, a pregnancy, or any birth defect of a newborn child. Conditions that exist and are treated at the same time or are due to the same or related causes are considered to be one illness.

Intensified Outpatient Program: as provided for the treatment of substance abuse, intensified outpatient program refers to a program provided as a continuation of inpatient substance abuse treatment prescribed by a physician, under the management of a substance abuse provider, which is licensed or certified by the appropriate state or federal agency and is approved by the Plan.

Investigative or Experimental: use of a procedure, facility, equipment, drug, device, or supply not recognized at the time of treatment as accepted medical practice within the United States for the condition being treated. A drug, device, medical treatment, or procedure will be determined to be experimental or investigational if:

there are insufficient outcomes data available from controlled clinical trials published in the peer reviewed literature to substantiate its safety and effectiveness for the disease or injury involved; or it cannot be lawfully marketed without the approval of the Food and Drug Administration (FDA) or other governmental agency and such approval has not been granted at the time of its use or proposed use; or it is the subject of a current investigational new drug or new device application on file with the FDA; or a recognized national medical or dental society or regulatory agency has determined, in writing, that it is experimental, investigational, or for research purposes; or a written protocol or protocols used by the treating facility, or the protocol or protocols of any other facility studying substantially the same drug, device, procedure, or treatment, or the written informed consent used by the treating facility or by another facility studying the same drug, device, procedure, or treatment states that it is experimental, investigational, or for research purposes. It is being provided pursuant to:

  • A Phase I or Phase II clinical trial or as the experimental or research arm of a Phase III clinical trial; or

  • A written protocol which describes among its objectives, determinations of safety, toxicity, effectiveness, or effectiveness in comparison to conventional alternatives; or

  • Is being delivered, or should be delivered subject to the approval and supervision of an Institutional Review Board (IRE) as required and defined by federal regulations particularly those of the FDA or the Department of Health and Human Services (HHS), or


Document info
Document views428
Page views428
Page last viewedTue Jan 24 07:59:37 UTC 2017