Laboratory Date of Service Policy

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. 

In the CY 2018 Hospital Outpatient Prospective Payment System (OPPS)/Ambulatory Surgical Center (ASC) final rule published December 14, 2017, CMS established another exception to laboratory DOS policy for Advanced Diagnostic Laboratory Tests (ADLTs) and molecular pathology tests excluded from OPPS packaging policy so that the DOS is the date the test was performed, if certain conditions are met. This new exception to the laboratory DOS policy is effective beginning on January 1, 2018. Specifically, in the case of a molecular pathology test or an ADLT that meets the criteria of section 1834A(d)(5)(A) of the Social Security Act, the date of service must be the date the test was performed only if the following conditions are met: 

  1. The test is performed following a hospital outpatient’s discharge from the hospital outpatient department; 
  2. The specimen was collected from a hospital outpatient during an encounter (as both are defined 42 CFR 410.2); 
  3. It was medically appropriate to have collected the sample from the hospital outpatient during the hospital outpatient encounter; 
  4. The results of the test do not guide treatment provided during the hospital outpatient encounter; and
  5. 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 separates the laboratory test from the hospital outpatient encounter. As a result, the laboratory performing the test must bill Medicare directly for the test, instead of seeking payment from the hospital outpatient department. 

A list of specific laboratory test Healthcare Common Procedure Coding System (HCPCS) codes subject to this new exception to laboratory DOS policy may be found in the Downloads section below. Please note that this list is updated quarterly as appropriate.

CMS will exercise enforcement discretion until January 2, 2020, for the laboratory date of service exception policy for advanced diagnostic laboratory tests and molecular pathology tests subject to the laboratory date of service exception policy. For additional information see the Downloads section below.

Page Last Modified:
04/02/2020 01:13 PM