Pathology/Lab Coding Alert

Just add up the lab tests, CMS says.

Despite consistent stakeholder recommendations to price Multi-analyte Assays with Algorithmic Analyses (MAAAs) in a manner that accounts for the cost of algorithm development, CMS says, "no," -- which means you can expect pay only for the underlying tests.

"Unlike a simple calculation, the algorithm should be recognized as a substantial and reimbursable component of the test," according to Peter Kazon, speaking on behalf of American Clinical Laboratory Association (ACLA) at the annual CMS Clinical Laboratory Fee Schedule (CLFS) public meeting.

Read on to learn what your lab can expect for MAAA and other new CPT® 2013 codes paid on the CLFS based on CMS's CY 2013 preliminary payment determinations (available at www.cms.gov/ClinicalLabFeeSched/).

Report Underlying Lab Tests for MAAAs

You'll find the following new codes in CPT® 2013, but you won't find new payment amounts on the CLFS, based on the CMS preliminary payment determination:

• 815XX1 -- Oncology (ovarian), biochemical assays of two proteins (CA-125 and HE4), utilizing serum, with menopausal status, algorithm reported as a risk score
• 815XX -- Oncology (ovarian), biochemical assays of five proteins (CA-125, apoliproprotein A1, beta-2 microglobulin, transferrin, and pre-albumin), utilizing serum, algorithm reported as a risk score
• 815XX -- Endocrinology (type 2 diabetes), biochemical assays of seven analytes (glucose, HbA1c, insulin, hs-CRP, adoponectin, ferritin, interleukin 2-receptor alpha), utilizing serum or plasma, algorithm reporting a risk score
• 815XX -- Fetal congenital abnormalities, biochemical assays of two proteins (PAPP-A, hCG [any form]), utilizing maternal serum, algorithm reported as a risk score
• 815XX -- Fetal congenital abnormalities, biochemical assays of three proteins (PAPP-A, hCG [any form], DIA), utilizing maternal serum, algorithm reported as a risk score
• 815XX -- Fetal congenital abnormalities, biochemical assays of three analytes (AFP, uE3, hCG [any form]), utilizing maternal serum, algorithm reported as a risk score
• 815XX -- Fetal congenital abnormalities, biochemical assays of four analytes (AFP, uE3, hCG [any form], DIA) utilizing maternal serum, algorithm reported as a risk score (may include additional results from previous biochemical testing)
• 815XX -- Fetal congenital abnormalities, biochemical assays of five analytes (AFP, uE3, total hCG, hyperglycosylated hCG, DIA) utilizing maternal serum, algorithm reported as a risk score

Here's why: "CMS uses other codes for payment of the underlying clinical laboratory tests on which the MAAA is done and does not recommend separately pricing the MAAAs codes," according to the agency. Further, "Medicare does not recognize a calculated or algorithmically derived rate or result as a clinical laboratory test...," states CMS.

Translation: You'll have to bill Medicare for an MAAA using the existing codes for the underlying tests, not using the new MAAA code, which CMS won't price on the CLFS.

For instance: Instead of billing Medicare for 815XX1, you would bill 86304 (Immunoassay for tumor antigen, quantitative; CA 125) and 86305 (Human epididymis protein 4 [HE4]).

CMS's MAAAs payment decision runs counter to recommendations given at the public meeting. Several commentators pointed out that MAAAs require development of complex algorithms that use test results and other clinical factors, as well as performance of clinical validation studies. Once established, the MAAA provides more information than the physician can glean from the clinical lab test results alone, commentators claimed.

Simply put: MAAA tests involve "substantial additional cost over the performance of the individual analytes ... [and result in] substantial additional information than one would get from [individual tests] alone," according to Paul Radensky, M.D., representing McDermott Will & Emery at the CMS public meeting.

Learn Crosswalks for New Codes

For most other new CPT® 2013 codes, CMS's preliminary payment determination involves crosswalking to existing codes that involve similar methodology and costs.

HLA: For the following two new codes to identify the presence or absence of human leukocyte antigens (HLA), CMS proposes the following crosswalks:

• 868XX -- Antibody to human leukocyte antigens (HLA), solid phase assays (e.g., microspheres or beads, ELISA, flow cytometry); qualitative assessment of the presence or absence of antibody(ies) to HLA Class I and Class II HLA antigensCrosswalk to 86807 (Serum screening for cytotoxic percent reactive antibody [PRA]; standard method)
• 868XX -- ... qualitative assessment of the presence or absence of antibody(ies) to HLA Class I or Class II HLA antigenCrosswalk to 86808 (... quick method)

For each of the other new HLA tissue typing codes to identify specific tumor antigens, CMS recommends crosswalking to multiples of 83516 (Immunoassay for analyte other than infectious agent antibody or infectious agent antigen; qualitative or semiquantitative, multiple step method), as follows:

• 868XX -- ... antibody identification by qualitative panel using complete HLA phenotypes, HLA Class I -- 83516 x 7
• 868XX -- ... antibody identification by qualitative panel using complete HLA phenotypes, HLA Class II -- 83516 x 6
• 68XX -- high definition qualitative panel for identification of antibody specificities (e.g., individual antigen per bead methodology), HLA Class I -- 83516 x 11
• 868XX -- ... high definition qualitative panel for identification of antibody specificities (egg, individual antigen per bead methodology), HLA Class I -- 83516 x 10
• 868XX -- ... semi-quantitative panel (e.g., titer), HLA Class I -- 83516 x 31
• 868XX -- ... semi-quantitative panel (e.g., titer), HLA Class II -- 83516 x 28

Each of these crosswalks represents "similar clinical resources used," according to Michael McEachin, M.D., representing the College of American Pathologists at the CLFS public meeting.

Gapfill: Other than molecular pathology codes, CMS recommends only one new code for gapfill payment -- 86152 (Cell enumeration using immunologic selection and identification in fluid specimen [e.g., circulating tumor cells in blood]). Gapfilling involves allowing individual Medicare contractors to price the new code for a period of time before CMS evaluates that pricing and sets a national rate.

Further resources: In addition to the new MAAAs and HLA codes, CPT® 2013 adds other codes in chemistry, immunology, and microbiology, as well as several new molecular pathology codes. See "Follow Medicare Pricing to See How You'll Fare in 2013" on page 83 and "Wait for Gapfill to Learn Your Molecular Pathology Pay" below in this issue to learn more about how CMS proposes to price those codes.