Laboratory/Pathology Services - CAM 472

Description:
The purpose of this policy is to outline when it is appropriate to allow reimbursement for the physician component of certain clinical pathology services. This policy also addresses the processing of automated laboratory tests.

Policy Statement:
Professional Clinical Laboratory
It has been customary to recognize the physician component of certain clinical pathology services for separate reimbursement when it is inappropriate for the physician to bill the global service because the technical component was rendered by a technician or another physician who performed the technical component of the service only. The technical component represents the facility charge for administering a service: machinery, technicians and supplies required to perform the procedure. The professional component represents the physician’s charge for direct involvement in performing or interpreting the procedure performed. Examples of professional components that are appropriate for reimbursement would include:

Interpretation and report of a clinical pathology examination rendered by a physician who has no association with the laboratory that prepared the specimen.

The factors necessary for the recognition of such services for reimbursement would include:

The interpretation and report must be necessary for the appropriate evaluation and treatment of the patient (medically necessary).
The interpretation and report must have been requested by the attending physician (a request for consultation).
The interpretation and report must be based on the physician’s personal evaluation of the pathological specimen or the specific laboratory findings. The physician must provide a written report signed by the physician that documents the interpretation or opinion.

Professional components are not recognized for routine clinical pathology services when those services involve testing of clinical specimens by automated machinery when the machine generates the test result without the necessity for physician interpretations.

A professional component of a technical service can be recognized as appropriate for reimbursement under the following guidelines:

The interpretation of the result and a written report is medically necessary for the appropriate evaluation and treatment of the patient.
The interpretation and report has been requested by the attending physician.
The interpretation in the report is based on the physician’s personal evaluation of the pathological specimen or the specific technical findings.
The reporting physician creates a report that is specific to the individual patient’s technical findings and signs and dates that report.

A professional component is recognized for codes CMS designates as appropriate for a separate professional interpretation. See the codes listed below:

83020	HEMOGLOBIN FRACTIONATION & QUANTITATION; ELECTROPHORESIS
84165	PROTEIN; ELECTROPHORETIC FRACTIONATION AND QUANTITATION
84166	PROTEIN; ELECTROPHORETIC FRACTIONATION AND QUANTITATION, OTHER FLUIDS WITH CONCENTRATION (E.G., URINE, CSF)
84181	PROTEIN; WESTERN BLOT, W/ INTERPRETATION & REPORT, BLOOD/OTHER BODY FLUID
84182	PROTEIN; WESTERN BLOT, W/ INTERPRETATION & REPORT, W/ IMMUNOLOGICAL PROBE, EACH
85060	BLOOD SMEAR, PERIPHERAL, INTERPRETATION, PHYSICIAN W/ WRITTEN REPORT
85390	FIBRINOLYSINS/COAGULOPATHY SCREEN, INTERPRETATION & REPORT
85576	PLATELET; AGGREGATION (IN VITRO), EACH AGENT
86153	Cell enumeration using immunologic selection and identification in fluid specimen (e.g., circulating tumor cells in blood); physician interpretation and report, when required
86255	FLUORESCENT NONINFECTIOUS AGENT ANTIBODY; SCREEN, EACH ANTIBODY
86256	FLUORESCENT NONINFECTIOUS AGENT ANTIBODY; TITER, EACH ANTIBODY
86320	IMMUNOELECTROPHORESIS; SERUM
86325	IMMUNOELECTROPHORESIS; OTHER FLUIDS W/ CONCENTRATION
86327	IMMUNOELECTROPHORESIS; CROSSED (2-DIMENSIONAL ASSAY)
86334	IMMUNOFIXATION ELECTROPHORESIS
86335	IMMUNOFIXATION ELECTROPHORESIS; OTHER FLUIDS WITH CONCENTRATION (E.G., URINE, CSF)
87164	DARK FIELD EXAM, ANY SOURCE; W/ COLLECTION
87207	SMEAR, PRIMARY SOURCE WITH INTERPRETATION; SPECIAL STAIN FOR INCLUSION BODIES OR PARASITES (E.G., MALARIA, COCCIDIA, MICROSPORIDIA, TRYPANOSOMES, HERPES VIRUSES)
88104	CYTOPATHOLOGY EXCEPT CERVICAL/VAGINAL; SMEARS W/ INTERPRETATION
88106	CYTOPATHOLOGY, FLUIDS, WASHINGS OR BRUSHINGS, EXCEPT CERVICAL OR VAGINAL; SIMPLE FILTER METHOD WITH INTERPRETATION
88108	CYTOPATHOLOGY, CONCENTRATION TECHNIQUE, SMEARS & INTERPRETATION
88112	CYTOPATHOLOGY, SELECTIVE CELLULAR ENHANCEMENT TECHNIQUE WITH INTERPRETATION (E.G., LIQUID BASED SLIDE PREPARATION METHOD), EXCEPT CERVICAL OR VAGINAL
88120	CYTOPATHOLOGY, IN SITU HYBRIDIZATION (E.G., FISH), URINARY TRACT SPECIMEN WITH MORPHOMETRIC ANALYSIS, 3-5 MOLECULAR PROBES, EACH SPECIMEN; MANUAL
88121	CYTOPATHOLOGY, IN SITU HYBRIDIZATION (E.G., FISH), URINARY TRACT SPECIMEN WITH MORPHOMETRIC ANALYSIS, 3-5 MOLECULAR PROBES, EACH SPECIMEN; USING COMPUTER-ASSISTED TECHNOLOGY
88125	CYTOPATHOLOGY, FORENSIC
88160	CYTOPATHOLOGY, OTHER SOURCE; SCREENING & INTERPRETATION
88161	CYTOPATHOLOGY, OTHER SOURCE; PREPARATION, SCREENING & INTERPRETATION
88162	CYTOPATHOLOGY, OTHER SOURCE; EXTENDED STUDY, > 5 SLIDES &/OR MULTIPLE STAINS
88172	CYTOPATHOLOGY, EVAL FINE NEEDLE ASPIRATE; IMMEDIATE CYTOHISTOLOGIC STUDY TO DETERMINE ACCURACY
88173	CYTOPATHOLOGY, EVAL FINE NEEDLE ASPIRATE; INTERPRETATION & REPORT
88177	CYTOPATHOLOGY, EVALUATION OF FINE NEEDLE ASPIRATE; IMMEDIATE CYTOHISTOLOGIC STUDY TO DETERMINE ADEQUACY FOR DIAGNOSIS, EACH SEPARATE ADDITIONAL EVALUATION EPISODE, SAME SITE (LIST SEPARATELY IN ADDITION TO CODE FOR PRIMARY PROCEDURE)
88182	FLOW CYTOMETRY, CELL CYCLE OR DNA ANALYSIS
88199	UNLISTED CYTOPATHOLOGY PROC
88300	LEVEL I — SURGICAL PATHOLOGY, GROSS EXAM ONLY
88302	LEVEL II — SURGICAL PATHOLOGY, GROSS & MICROSCOPIC EXAM
88304	LEVEL III — SURGICAL PATHOLOGY, GROSS & MICROSCOPIC EXAM
88305	LEVEL IV — SURGICAL PATHOLOGY, GROSS & MICROSCOPIC EXAM
88307	LEVEL V — SURGICAL PATHOLOGY, GROSS & MICROSCOPIC EXAM
88309	LEVEL VI — SURGICAL PATHOLOGY, GROSS & MICROSCOPIC EXAM
88311	DECALCIFICATION PROC
88312	SPECIAL STAINS (LIST SEPARATELY IN ADDITION TO CODE FOR PRIMARY SERVICE); GROUP I FOR MICROORGANISMS (E.G., GRIDLEY, ACID FAST, METHENAMINE SILVER), EACH
88313	SPECIAL STAINS (LIST SEPARATELY IN ADDITION TO CODE FOR PRIMARY SERVICE); GROUP II, ALL OTHER (E.G., IRON, TRICHROME), EXCEPT IMMUNOCYTOCHEMISTRY AND IMMUNOPEROXIDASE STAINS, EACH
88314	SPECIAL STAINS; HISTOCHEMICAL STAINING W/ FROZEN SECTION(S)
88319	DETERMINATIVE HISTOCHEMISTRY/CYTOCHEMISTRY, IDENTIFY ENZYME CONSTITUENTS, EACH
88323	CONSULTATION & REPORT, REFERRED MATL REQUIRING PREPARATION, SLIDES
88331	PATHOLOGY CONSULTATION DURING SURGERY; FIRST TISSUE BLOCK, W/ FROZEN SECTION(S), SINGLE SPECIMEN
88332	PATHOLOGY CONSULTATION DURING SURGERY; EACH ADD'L TISSUE BLOCK W/ FROZEN SECTION(S)
88333	PATHOLOGY CONSULTATION DURING SURGERY; CYTOLOGIC EXAMINATION (E.G., TOUCH PREP, SQUASH PREP), INITIAL SITE
88334	PATHOLOGY CONSULTATION DURING SURGERY; CYTOLOGIC EXAMINATION (E.G., TOUCH PREP, SQUASH PREP), EACH ADDITIONAL SITE
88341	IMMUNOHISTOCHEMISTRY OR IMMUNOCYTOCHEMISTRY, PER SPECIMEN; EACH ADDITIONAL SINGLE ANTIBODY STAIN PROCEDURE (LIST SEPARATELY IN ADDITION TO CODE FOR PRIMARY PROCEDURE.
88342	IMMUNOHISTOCHEMISTRY (INCLUDING TISSUE IMMUNOPEROXIDASE), EACH ANTIBODY
88344	IMMUNOHISTOCHEMISTRY OR IMMUNOCYTOCHEMISTRY, PER SPECIMEN; EACH MULTIPLEX ANTIBODY STAIN PROCEDURE
88346	Immunofluorescence, per specimen; initial single antibody stain procedure
88348	ELECTRON MICROSCOPY; DX
88350	Immunofluoroscence, per specimen; each additional single antibody stain procedure (List separately in addition to code for primary procedure)
88355	MORPHOMETRIC ANALYSIS; SKELETAL MUSCLE
88356	MORPHOMETRIC ANALYSIS; NERVE
88358	MORPHOMETRIC ANALYSIS; TUMOR (E.G., DNA PLOIDY)
88360	MORPHOMETRIC ANALYSIS, TUMOR IMMUNOHISTOCHEMISTRY (E.G., HER-2/NEU, ESTROGEN RECEPTOR/PROGESTERONE RECEPTOR), QUANTITATIVE OR SEMIQUANTITATIVE, EACH ANTIBODY; MANUAL
88361	MORPHOMETRIC ANALYSIS, TUMOR IMMUNOHISTOCHEMISTRY (E.G., HER-2/NEU, ESTROGEN RECEPTOR/PROGESTERONE RECEPTOR), QUANTITATIVE OR SEMIQUANTITATIVE, EACH ANTIBODY; USING COMPUTER-ASSISTED TECHNOLOGY
88362	NERVE TEASING PREPARATIONS
88364	IN SITU HYBRIDIZATION (E.G., FISH), PER SPECIMEN; EACH ADDITIONAL SINGLE PROBE STAIN PROCEDURE (LIST SEPARATELY IN ADDITION TO CODE FOR PRIMARY PROCEDURE)
88365	TISSUE IN SITU HYBRIDIZATION, INTERPRETATION & REPORT
88366	IN SITU HYBRIDIZATION (E.G., FISH), PER SPECIMEN; EACH MULTIPLEX PROBE STAIN PROCEDURE
88367	MORPHOMETRIC ANALYSIS, IN SITU HYBRIDIZATION (QUANTITATIVE OR SEMI-QUANTITATIVE) EACH PROBE; USING COMPUTER-ASSISTED TECHNOLOGY
88368	MORPHOMETRIC ANALYSIS, IN SITU HYBRIDIZATION (QUANTITATIVE OR SEMI-QUANTITATIVE) EACH PROBE; MANUAL
88369	MORPHOMETRIC ANALYSIS, IN SITU HYBRIDIZATION (QUANTITATIVE OR SEMI-QUANTITATIVE), MANUAL, PER SPECIMEN; EACH ADDITIONAL SINGLE PROBE STAIN PROCEDURE (LIST SEPARATELY IN ADDITION TO CODE FOR PRIMARY PROCEDURE)
88371	PROTEIN ANALYSIS, TISSUE, WESTERN BLOT, W/ INTERPRETATION & REPORT
88372	PROTEIN ANALYSIS, TISSUE, WESTERN BLOT, W/ INTERPRETATION & REPORT; IMMUNOLOGICAL PROBE, EACH
88373	MORPHOMETRIC ANALYSIS, IN SITU HYBRIDIZATION (QUANTITATIVE OR SEMI-QUANTITATIVE), USING COMPUTER-ASSISTED TECHNOLOGY, PER SPECIMEN; EACH ADDITIONAL SINGLE PROBE STAIN PROCEDURE (LIST SEPARATELY IN ADDITION TO CODE FOR PRIMARY PROCEDURE)
88374	MORPHOMETRIC ANALYSIS, IN SITU HYBRIDIZATION (QUANTITATIVE OR SEMI-QUANTITATIVE), USING COMPUTER-ASSISTED TECHNOLOGY, PER SPECIMEN; EACH MULTIPLEX PROBE STAIN PROCEDURE
88377	MORPHOMETRIC ANALYSIS, IN SITU HYBRIDIZATION (QUANTITATIVE OR SEMI-QUANTITATIVE), MANUAL, PER SPECIMEN; EACH MULTIPLEX PROBE STAIN PROCEDURE
88380	MICRODISSECTION (I.E., SAMPLE PREPARATION OF MICROSCOPICALLY IDENTIFIED TARGET); LASER CAPTURE
88381	MICRODISSECTION (I.E., SAMPLE PREPARATION OF MICROSCOPICALLY IDENTIFIED TARGET); MANUAL
88399	UNLISTED SURGICAL PATHOLOGY PROC
89060	CRYSTAL IDENTIFICATION BY LIGHT MICROSCOPY WITH OR WITHOUT POLARIZING LENS ANALYSIS, TISSUE OR ANY BODY FLUID (EXCEPT URINE)

Automated Multi Channel Chemistry Tests
Twenty-three common laboratory tests are classified as "automated, multichannel chemistry tests." The automated test list is based on the 19 tests that could be performed on the original automated chemistry analyzers. GGT, triglycerides, CPK and iron were added later. The current list of automated tests includes:

Albumin, alkaline phosphatase, AST, ALT, direct and total bilirubin, BUN, carbon dioxide, calcium, cholesterol, chloride, CPK, creatinine, glucose, glucose-6-phosphate dehydrogenase, GGT, LDH, phosphorus, potassium, total protein, sodium, triglycerides, uric acid and iron.

Regardless of the method used to perform the tests, whether by the automated or non-automated method, the allowance for the individual tests will be limited to the amount paid for the corresponding automated panel.

Medicare Coordination of Laboratory Services of the State of South Carolina:
The Omnibus Budget Reconciliation Act clarifies the mandatory assignment provision, which applies to laboratory services performed in a physician’s office. Assigned claims for clinical laboratory services are reimbursed at 100% of the approved amount with no coinsurance or deductible applied.

Physicians must accept assignment for clinical diagnostic laboratory services performed by the physician or under their supervision. Medicare will deny any clinical laboratory charges filed by a non-participating physician on non-assigned claims as non-covered.

Non-participating physicians who render a clinical laboratory service and other office services on the same date may file two separate claims. An example of this would be one accepting assignment for the clinical lab service and the other non-assigned claim for other services. This is the only instance where Medicare accepts two different assignment intentions for the same date of service.

As assigned laboratory claims are reimbursed at 100% of the approved amount, there is no coordinated payment. These charges should be submitted with a provider remittance and should be non-covered as paid in full by Medicare.

Claims that are submitted for coordination should always have an Explanation of Medicare Benefits or Provider Remittance attached. If either of these items is missing, charges should be non-covered for lack of Medicare information.

This medical policy was developed through consideration of peer-reviewed medical literature generally recognized by the relevant medical community, U.S. FDA approval status, nationally accepted standards of medical practice and accepted standards of medical practice in this community, Blue Cross Blue Shield Association technology assessment program (TEC) and other non-affiliated technology evaluation centers, reference to federal regulations, other plan medical policies and accredited national guidelines.

History From 2014 Forward

01/18/2023	Annual review, no change to policy intent.
01/05/2022	Annual review, no change to policy intent.
01/06/2021	Annual review, no change to policy intent.
01/02/2020	Annual review, no change to policy intent.
08/01/2019	Annual review, no change to policy intent.
08/07/2018	Annual review, no change to policy intent.
03/28/2018	Interim review to remove codes that CMS no longer supports a 26 modifier with:80500, 80502, 85097, 85396, 86077, 8607886079, 86485, 86486, 86490, 86510, 86580,88141, 88187, 88188, 88291, 88299, 88321, 88325, 88329, 89049, 89220, 89230, 89240, G0124 and G0141. No other changes made.
08/01/2017	Interim review removing 88184, 88185 from the list of codes appropriate for a 26 modifier as they are technical component only by verbiage. No other changes.
04/26/2017	Updated category to Laboratory. No other changes.
01/05/2017	Annual review, no change to policy intent.
01/11/2016	Annual review, no change to intent of policy, updating verbiage for 88346, removing deleted code 88347 adding new code 88350.
09/01/2015	Annual review, updated coding to maintain current coding. Also changed review date to January to allow for coding update at that time.
09/11/2014	Annual review, updated codes listed to include new codes and remove deleted coding. No change to policy intent. Additional note, codes added and deleted were confirmed with Pam Herring utilizing CMS data.
04/17/2014	Made Policy external.

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Laboratory/Pathology Services - CAM 472