Drug Evaluation Committee 2011-31 Coverage of the uninsured concomitant therapy fee system (Interpretation of the Notice on Uninsured Combination Therapy Fees)
Related classification: Other
Date of first publication: November 2011
Question
We have a question regarding the Explanation of the JPMA document "Regarding the Uninsured Combination Medical Fee System for Medical Treatments Related to Clinical Trials of Pharmaceuticals" issued in March 2011.
Scope of Investigations and Diagnostic Imaging" on page 9, the current situation is that the cost of tests and diagnostic imaging at medical institutions other than the Investigator Site is borne by the patient (insurance benefit), even if the costs are within the "clinical trial period. Does this Explanation mean that the costs of tests and diagnostic imaging at other institutions must also be borne by the company or paid by insurance if they are within the "clinical trial period"?
JPMA's Opinion
The uninsured combined medical care reimbursement system is only applicable when the sponsor has entered into a contract as the Investigator Site. Therefore, as you understand, the costs of examinations and diagnostic imaging at Investigator Sites that are not related to the Investigator Site are covered by insurance even during the period of the clinical trial.
This example is based on the assumption that tests that cannot be performed at the Investigator Site are outsourced to other facilities. In such cases, the sponsor can bear the costs of tests and diagnostic imaging during the clinical trial period by concluding an outsourcing agreement as the facility that performs the tests.