Test Bulletin

ACL Client Services | (800) 877-7016 | www.acllaboratories.com

ACL Laboratories Announces the American Medical Associations 2013 CPT Code RevisionsEach year the American Medical Association (AMA) publishes CPT codes describing different assays, procedures and services that are billed by healthcare providers. There is a significant change to the laboratory/pathology section this year affecting molecular pathology testing.

The section designated with codes 83890-83914 intended for use with molecular diagnostic techniques for analysis of nucleic acids has been deleted. A new section of codes 81200-81479 has been created to specifically report and bill for gene-specific and genomic procedures.

An additional challenge laboratories face this year is many of the new codes will not have a published Medicare reimbursement. Currently, these codes will be priced by the individual payers at undetermined rates. Please be sure to check the ACL Laboratories Directory of Services throughout the year for the most current CPT code assignment.

Below are the new code assignments ACL Laboratories is able to publish as of January 1, 2013 along with any known Medicare reimbursements:

Please refer to the ACL Laboratories Directory of Services (acllaboratories.com/tests-directory/search-tests.asp) for specimen collection requirements.

ACL Test Test Description 2013 CPT 2013 Medicare Order Code AJP Reimbursement 81209 81200 81260 81242 AJPR Ashkenazi Jewish Diseases 81251 Gap filled 81290 81330 81255 BCGR B-Cell Gene Rearrangement by PCR 81261 Gap filledBFGTQN BCR/ABL Gene Detection, Quantitative 81206 Gap filledBRAF BRAF Mutation by PCR 81210 Gap filledBRCAA BRCA Analysis 81211 Gap filledTXCHMA, Chromosome Microarray, SNP 81229 Gap filledTXCHMR CFMP Cystic Fibrosis Mutation Panel 81220 Gap filledCYP450 Cytochrome P450 2C19 9 Gene Mutations 81225 Gap filledEGFR EGFR Mutation 81235 Gap filledTX5FL Factor V Genotype 81241 Gap filledFRAGXR Fragile X Syndrome 81244 Gap filledTXHFEG HFE Genotype 81256 Gap filledMLH1M hMLH1 Methylation 81479 Gap filledJAK2, JAK2B, JAK2 Mutation Qualitative or Quantitative 81270 Gap filledJAK2QN JAK2 Mutation Qualitative or Quantitative 81270 Gap filledJAK2QN JAK2 Mutation Qualitative or Quantitative 81270 Gap filled

FRAGXR Fragile X Syndrome 81244 Gap filled

Continued

Effective Wednesday, January 30, 2013

Test Bulletin

ACL Client Services | (800) 877-7016 | www.acllaboratories.com

Please refer to the ACL Laboratories Directory of Services (acllaboratories.com/tests-directory/search-tests.asp) for specimen collection requirements.

For additional information about the new CPT Codes, please contact ACL Laboratories Compliance Department -- Kathy Lindgren 414-328-7916 or Mary Bieze 847-349-7512.

ACL Test Test Description 2013 CPT 2013 Medicare Order Code AJP ReimbursementKRAS KRAS Mutation 81275 Gap filledMCC Maternal Cell Contamination 81265 Gap filledTXMTHF MTHFR Genotype 81291 Gap filledTPMTGR TPMT Genetics 81401 Gap filledTXPTM Prothrombin Gene Mutation 81240 Gap filled

TCGR T-Cell Gene Rearrangement by PCR 81340 Gap filled 81342TCGR T-Cell Gene Rearrangement by PCR 81342TCGR T-Cell Gene Rearrangement by PCR

TISSMSI Tissue Microsatellite Instability 81301 Gap filledCTCC Circulating Tumor Cell Count 86152 Gap filledMINRVP Influenza and RSV Panel by PCR 87632 $176.34RVPNL Comprehensive Respiratory Viral Panel by PCR 87633 $572.91

ACL Laboratories Announces New Tests for Prescription Drug Management (Test Order Codes: DMDOA, DM1, DM2, DMBZO)

In an effort to meet the needs of Prescription Drug Management clinicians, ACL Laboratories has developed new drug panels. These assays employ state-of-the-art LC Triple Quad instrumentation as well as GC/MS to identify and quantitate a wide variety of drugs of abuse, prescription pain relievers and their primary metabolites in urine. The LC Triple Quad is Liquid chromatography/Tandem Mass Spectrometry (LC/MS/MS) and GC/MS is Gas Chromatography/Mass Spectrometry.

Specifically, the Drugs of Abuse panel for Drug Management (Test Order Code DMDOA) will detect Cannabinoids, Cocaine, Amphetamines, PCP and Heroin. The Drug Management Panel 1 (Test Order Code DM1) will detect Codeine, Morphine, Oxycodone, Oxymorphone, Noroxycodone, Hydrocodone, Hydromorphone, Methadone and EDDP. The Drug Management Panel 2 (Test Order Code DM2) adds Fentanyl, Norfentanyl, Propoxyphene, Tramadol, Nortramadol, Meperidine, Normeperidine, Meprobamate and Gabapentin. In addition, any of these drug levels can be ordered as a single test.

Test Order Code DMBZO is the new Benzodiazepine confirmation and includes Nordiazepam, Oxazepam, Temazepam, Alpha-hydroxy Alprazolam, Lorazepam, Des-alkyl Flurazepam and 7-amino Clonazepam.

For additional information about these tests and for specimen collection instructions, please visit ACL Laboratories Directory of Services at acllaboratories.com.

Test Bulletin

ACL Client Services | (800) 877-7016 | www.acllaboratories.com

ACL Laboratories Offers New Test for Evaluation of Thrombocytopenia –Immature Platelet Fraction ( Test Order Code IPF)

ACL Laboratories Offers New Test -- Aggressive Lymphoma Panel by FISH (Test Order Code FISHAG)

The Immature Platelet Fraction (Test Order Code IPF) is an index of thrombopoiesis and can help determine the mechanism of thrombocytopenia. An increased IPF in the presence of thrombocytopenia is typically indicative of platelet destruction or consumption. A decreased or low normal IPF in the presence of thrombocytopenia is typically indicative of decreased marrow production.

Newly released platelets are larger and more reactive than mature platelets. They contain RNA and are the platelet analogue of the red cell reticulocyte and are in fact called ‘reticulated platelets’. The number of reticulated platelets reflects the rate of thrombopoiesis, increasing when platelet production rises and decreasing when production falls. Reticulated platelets can be quantified flow cytometrically using a fluorescent dye that binds RNA. In thrombocytopenic conditions, platelet RNA content correlates directly with megakaryocyte activity.

Patients with Idiopathic Thrombocytopenic Purpura (ITP), Thrombotic Thrombocytopenic Purpura (TTP), and Disseminated Intravascular Coagulation (DIC) demonstrate the highest IPF, indicating active platelet production. Patients with regenerating marrows also typically have high IPF. Patients with decreased production, including those undergoing cytotoxic chemotherapy, have IPF in the low or low normal range. IPF may also be useful as an indicator of imminent platelet recovery after cytotoxic therapy or post transplant, and IPF usually increases before the platelet count. IPF may potentially avoid the need for marrow examination in patients with thrombocytopenia.

The reference range is: 1% - 7%.

For more information about this test or to learn about specimen collection requirements, please visit our website at acllaboratories.com.

References:

Briggs, C. et al. Assessment of an immature platelet fraction (IPF) in peripheral thrombocytopenia. Br J Haematol. 2004 Jul;126(1):93-9

Kickler, TS. et al. A clinical evaluation of high fluorescent platelet fraction percentage in thrombocytopenia. Am J Clin Pathol. 2006 Feb;125(2):282-7

ACL Laboratories now offers a new Aggressive Lymphoma Fluorescence In Situ Hybridization (FISH) panel composed of three different probe sets designed to detect rearrangements of the BCL2, BCL6 and MYC genes, using the BCL2/IGH rearrangement probes, the BCL6 break-apart probes, and MYC break-apart probes respectively. This panel is used to detect “double-hit” or “triple hit” lymphomas which can support the diagnosis of “B-cell lymphoma, unclassifiable, with features intermediate between diffuse large B-cell lymphoma and Burkitt lymphoma,” an aggressive lymphoma with a poor prognosis. For additional information about this new test, please refer to the ACL Directory of Services at acllaboratories.com.

Please refer to the ACL Laboratories Directory of Services (acllaboratories.com/tests-directory/search-tests.asp) for specimen collection requirements.

ACL Client Services | (800) 877-7016 | www.acllaboratories.com

Please refer to the ACL Laboratories Directory of Services (acllaboratories.com/tests-directory/search-tests.asp) for specimen collection requirements.

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Test BulletinACL Laboratories Offers New Test for Functional Iron Deficiency – The Reticulocyte Hemoglobin Equivalent (Test Order Code RETHE)

Reticulocyte Hemoglobin Equivalent (Test Order Code RETHE) is a direct assessment of the incorporation of iron into erythrocyte hemoglobin and a direct estimate of the recent functional availability of iron in the red cell. The concept of functional iron deficiency (FID) has been established because estimates of iron storage do not provide good assessment of the availability of iron for incorporation into erythrocyte hemoglobin. This concept is particularly relevant to the patients who receive recombinant human erythropoietin (r-HuEPO), in whom the cellular requirements for iron are increased. It can lead to decreased iron incorporation into cellular hemoglobin and hamper the effectiveness of the therapy in anemic patients. Ret-He is an established parameter in the National Kidney Foundation guidelines for assessing the initial iron status and to assess IV iron replacement of hemodialysis patients with chronic kidney disease in which there may be a functional iron deficiency.

The routine parameters derived from the CBC give no information about newly produced red cells, the reticulocytes. Since red blood cells have a lifespan of about 120 days, RBC parameters represent a time averaged value only. Consequently, parameters like MCV and MCH, or percentage of hypochromic RBCs will only indicate a change in erythropoietic activity at an advanced stage of iron deficiency. Thus the Ret-He has the capability to identify iron deficiency earlier than traditional parameters.

The reference range is: 28.6 – 36.3.

A low Ret-He is indicative of iron deficiency. With a Ret-He above the normal range, a patient may not respond to additional iron therapy.

For more information about this test or to learn about specimen collection requirements, please visit our website at acllaboratories.com.

References:

Mast AE, Blinder MA, Lu Q, Flax S, Dietzen DJ. Clinical utility of the reticulocyte hemoglobin content in the diagnosis of iron deficiency.Blood 2002;99:1489-91.

Briggs C, Rogers R, Thompson B, Machin J. New red cell parameterson the Sysmex XE-2100 as potential markers of functionaliron deficiency. Sysmex J Int 2001;11:63-8.