Laboratory Date of Service - Advanced Diagnostic Laboratory Tests (ADLT) and Molecular Pathology Tests

Noridian has received notice of errors from the Comprehensive Error Rate Testing Contractor (CERT) for laboratory claims denied based on CMS Internet Only Manual (IOM), Publication 100-04 Medicare Claims Processing Manual , Chapter 16, Section 40.8. C.

"In general, the date of service (DOS) for clinical diagnostic laboratory tests is the date of specimen collection unless the physician orders the test at least 14 days following the patient's discharge from the hospital. When the "14-day rule" applies, the DOS is the date the test is performed, instead of the date of specimen collection."

Exception C states: "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 hospital outpatient discharge from hospital outpatient department;
  • The specimen collected during hospital outpatient 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 tests do not guide treatment provided during hospital outpatient encounter: and
  • The test was reasonable and medically necessary for the treatment of an illness."

"If all of the requirements are met, the DOS of the test must be the date the test was performed, which effectively unbundles the laboratory test from the hospital outpatient encounter. As a result, the test is not considered a hospital outpatient service for which the hospital must bill Medicare and for which the performing laboratory must seek payment from the hospital, but rather a laboratory test under the Clinical Laboratory Fee Schedule for which the performing laboratory must bill Medicare directly."

It is recommended that the date the test is performed is documented in the report.

Code of Federal Regulations defines an outpatient as:

  • A person who has not been admitted as inpatient but is registered on the hospital or critical access hospital (CAH) records as an outpatient and receives services directly from the hospital or CAH.

For a billing practitioner's office, CMS has published Frequently Asked Questions Revised Laboratory Date of Service Exception Policy that states, "A non-patient is a patient that is not registered as a hospital outpatient, and the laboratory DOS exception does not apply."

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