Mid Del Therapeutic Center, Inc. - Page 7

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            Ishmael frequently adjusted a patient's chemotherapy treatment in                          
            accordance with the patient's response to the treatment.                                   
            The Chemotherapy Drugs and Ancillary Medications Used in                                   
                  After a chemotherapy drug has been tested and scientifically                         
            proven effective to treat a particular condition, it is approved                           
            for use by the Food and Drug Administration.  Once a drug is                               
            approved, it can be used to treat conditions other than those for                          
            which it is approved because chemotherapy drugs may be effective                           
            against multiple forms of cancer.  For example, a drug approved                            
            for use against ovarian cancer might be used to treat lung                                 
            cancer, even though its use to treat lung cancer is not an                                 
            approved use.  Petitioners were not reimbursed by Medicare for                             
            their use of approved drugs if the condition for which the drug                            
            was administered was not an approved use, on the grounds that                              
            such treatments were experimental.                                                         
                  Dr. Ishmael treated some of his patients with drugs that                             
            were not approved for a particular condition when he believed the                          
            drug would help those patients, even though he knew that Medicare                          
            or nongovernmental health insurance carriers (private insurers)                            
            would not pay for costs associated with experimental treatments.                           
            Although petitioners bore the cost of these treatments, Dr.                                
            Ishmael authorized the treatments when he felt that they were                              

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Last modified: May 25, 2011