Date of Service (DOS) for Clinical Laboratory and Pathology Specimens
MLN Matters Number: MM6018
Related Change Request (CR) #: 6018
Related CR Release Date: May 23, 2008
Effective Date: January 1, 2009
Related CR Transmittal #: R1515CP
Implementation Date: January 5, 2009
Provider Types Affected
Providers who submit claims to Medicare Administrative Contractors (A/B MACs), fiscal intermediaries (FIs) or carriers, for laboratory tests, or the technical component of physician pathology services, provided to Medicare beneficiaries.
Impact on Providers
This article is based on Change Request (CR) 6018 alerting providers that the Centers for Medicare & Medicaid Services (CMS) revised the DOS policy for clinical laboratory tests and added the technical component of physician pathology service effective January 1, 2009. These changes were announced in the final Medicare physician fee schedule rule published in the Federal Register on November 27, 2007 (42 CFR § 414.510).
Key Points of CR 6018
The DOS policy as specified in 42 CFR § 414.510 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
The following two exceptions apply to this DOS policy for either a clinical laboratory test or the technical component of physician pathology service:
1. 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.
2. 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 contractors.
Additional Information
For complete details regarding this CR please see the official instruction (CR 6018) issued to your Medicare FI, A/B MAC, or carrier. That instruction may be viewed by going to www.cms.hhs.gov/Transmittals/downloads/R1515CP.pdf (PDF, 138 KB).
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Disclaimer
This article was prepared as a service to the public and is not intended to grant rights or impose obligations. This article may contain references or links to statutes, regulations, or other policy materials. The information provided is only intended to be a general summary. It is not intended to take the place of either the written law or regulations. We encourage readers to review the specific statutes, regulations and other interpretive materials for a full and accurate statement of their contents. CPT only copyright 2007 American Medical Association.