The new lab date of service policy determines the date of service for molecular pathology tests and Advanced Diagnostic Laboratory Tests (ADLTs) that are not packaged under the Outpatient Prospective Payment System (OPPS) in certain circumstances. The date of service for these tests is the date the test is performed for outpatients when:
- The physician orders the test following the date of 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 42 CFR 410.2);
- It would be medically inappropriate to have collected the sample from the hospital outpatient other than 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.
This means for tests sent from a hospital laboratory to a reference laboratory for testing, the reference laboratory will bill Medicare directly.
Molecular pathology tests and Advanced Diagnostic Laboratory Tests (ADLTs) under Criterion A (defined below) that are not packaged under the Outpatient Prospective Payment System (OPPS).
Molecular pathology tests are defined by the CPT manual. There are Tier 1 Molecular Pathology codes 81105 – 81383, Tier 2 codes 81400-81408 and unlisted molecular pathology code 81479.
An ADLT is a clinical diagnostic laboratory test (CDLT) covered under Medicare Part B that is offered and furnished only by a single laboratory and cannot be sold for use by a laboratory other than the single laboratory that designed the test or a successor owner. Criterion A ADLTs are tests that are an analysis of multiple biomarkers of deoxyribonucleic acid (DNA), ribonucleic acid (RNA), or proteins; when combined with an empirically derived algorithm, yields a result that predicts the probability a specific individual patient will develop a certain condition(s) or respond to a particular therapy(ies); provides new clinical diagnostic information that cannot be obtained from any other test or combination of tests; and may include other assays. There are currently no codes designated as ADLTs.
Laboratory tests not packaged under OPPS will have a Status Indicator (SI) of “A” on the OPPS Addendum B.
Based on this, CPT codes currently affected by the new lab date of service policy are: CPT 81105-81383, CPT 81400-81408, and CPT 81479.
What’s Not Included?
After the Molecular Pathology codes in the CPT manual, there are genomic sequencing procedures (GSPs) codes 81410-81471 and then multianalyte assays with algorithmic analyses (MAAAs) codes 81490 – 81599. The OPPS Final Rule makes it clear that the GSP and protein-based MAAA codes are not included in the new lab date of service rule.
Also not included are Proprietary Laboratory Analysis (PLAs). The American Medical Association (AMA) assigns PLA codes and includes the following definition on their website: “PLA codes are alpha-numeric CPT® codes with a corresponding descriptor, for labs or manufacturers to more specifically identify their test. Tests with PLA codes must be performed on human specimens and must be requested by the clinical laboratory or manufacturer that offers the test.” Current PLA codes are in the range of 0001U - 0034U.
Criterion B ADLTs (ADLTs cleared or approved by the FDA) are also not included in the revised lab date of service policy.