Date of Service (DOS) for Clinical Laboratory and Pathology Specimens

40.8 - Date of Service (DOS) for Clinical Laboratory and Pathology Specimens (Rev. 4481; Issued: 12-20-19, Effective: 01-01-20, Implementation: 01-23-20) The DOS policy for either a clinical laboratory test or the technical component of physician pathology service is as follows: General Rule: The DOS of the test/service must be the date the specimen was collected. Variation: If a specimen is collected over a period that spans two calendar days, then the DOS must be the date the collection ended. Exceptions: The following three exceptions apply to the DOS policy for either a clinical laboratory test or the technical component of physician pathology service: A. DOS for Tests/Services Performed on Stored Specimens: In the case of a test/service performed on a stored specimen, if a specimen was stored for less than or equal to 30 calendar days from the date it was collected, the DOS of the test/service must be the date the test/service was performed only if: • The test/service is ordered by the patient’s physician at least 14 days following the date of the patient’s discharge from the hospital; • The specimen was collected while the patient was undergoing a hospital surgical procedure; • It would be medically inappropriate to have collected the sample other than during the hospital procedure for which the patient was admitted; • The results of the test/service do not guide treatment provided during the hospital stay; and • The test/service was reasonable and medically necessary for treatment of an illness. If the specimen was stored for more than 30 calendar days before testing, the specimen is considered to have been archived and the DOS of the test/service must be the date the specimen was obtained from storage. B. DOS for Chemotherapy Sensitivity Tests/Services Performed on Live Tissue: In the case of a chemotherapy sensitivity test/service performed on live tissue, the DOS of the test/service must be the date the test/service was performed only if: • The decision regarding the specific chemotherapeutic agents to test is made at least 14 days after discharge; • The specimen was collected while the patient was undergoing a hospital surgical procedure; • It would be medically inappropriate to have collected the sample other than during the hospital procedure for which the patient was admitted; • The results of the test/service do not guide treatment provided during the hospital stay; and • The test/service was reasonable and medically necessary for treatment of an illness. For purposes of applying the above exception, a “chemotherapy sensitivity test” is defined as a test that requires a fresh tissue sample to test the sensitivity of tumor cells to various chemotherapeutic agents. CMS identifies such tests through program instructions issued to the Medicare Administrative Contractors (MACs). C. DOS for Advanced Diagnostic Laboratory Tests and Molecular Pathology Tests: In the case of a molecular pathology test performed by a laboratory other than a blood bank or center, or a test designated by CMS as an ADLT under paragraph (1) of the definition of advanced diagnostic laboratory test in 42 CFR 414.502, the DOS must be the date the test was performed only if: ● The test was performed following a hospital outpatient’s discharge from the hospital outpatient department; ● The specimen was collected from a hospital outpatient during an encounter (as both are defined in 42 CFR 410.2); ● It was medically appropriate to have collected the sample from the hospital outpatient during the hospital outpatient encounter; ● The results of the test do not guide treatment provided during the hospital outpatient encounter; and ● The test was reasonable and medically necessary for the treatment of an illness. For the purpose of section 40.8.C, a “blood bank or center” means an entity whose primary function is the performance or responsibility for the performance of, the collection, processing, testing, storage and/or distribution of blood or blood components intended for transfusion and transplantation.