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 exception to the laboratory DOS policy was effective beginning on January 1, 2018. Additionally, in the CY 2021 Hospital Outpatient Prospective Payment System (OPPS)/Ambulatory Surgical Center (ASC) final rule published December 29, 2020, CMS established another exception to laboratory DOS policy for tests that are cancer-related protein-based Multianalyte Assays with Algorithmic Analyses (MAAAs) or the test described by CPT code 81490.
Specifically, under 42 CFR 414.510(b)(5), in the case of a molecular pathology test performed by a laboratory other than a blood bank or center, a test designated by CMS as an ADLT under paragraph (1) of the definition of an advanced diagnostic laboratory test in 42 CFR 414.502, a test that is a cancer-related protein-based MAAA, or the test described by CPT code 81490,, the date of service of the test 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.
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.
In the CY 2020 Hospital Outpatient Prospective Payment System (OPPS)/Ambulatory Surgical Center (ASC) final rule published on November 12, 2019, CMS finalized a revision to the laboratory DOS exception at 42 CFR 414.510(b)(5) to exclude molecular pathology tests when performed by laboratories that are blood banks or centers. CMS also adopted a definition of “blood bank or center” and clarified that this policy change categorically excludes molecular pathology testing performed by laboratories that are blood banks or blood centers from the laboratory DOS exception at 42 CFR 414.510(b)(5).
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.
The contents of this document do not have the force and effect of law and are not meant to bind the public in any way, unless specifically incorporated into a contract. This document is intended only to provide clarity to the public regarding existing requirements under the law.
Laboratory Tests Subject to Exceptions to Laboratory DOS Policy Defined at 42 C.F.R. § 414.510(b)(5) - Updated 03/29/2023 (ZIP)
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