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MEDICARE COVERAGE OF LABORATORY TESTING

Quarterly HOTLINE: Effective May 21, 2018. MEDICARE COVERAGE OF LABORATORY TESTING . Please remember when ordering LABORATORY tests that are billed to MEDICARE /Medicaid or other federally funded programs, the following requirements apply: 1. Only tests that are medically necessary for the diagnosis or treatment of the patient should be ordered. MEDICARE does not pay for screening tests except for certain specifically approved procedures and may not pay for non-FDA approved tests or those tests considered experimental. 2. If there is reason to believe that MEDICARE will not pay for a test, the patient should be informed. The patient should then sign an Advance Beneficiary Notice (ABN) to indicate that he or she is responsible for the cost of the test if MEDICARE denies payment. 3. The ordering physician must provide an ICD-10 diagnosis code or narrative description, if required by the fiscal intermediary or carrier. 4.

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Transcription of MEDICARE COVERAGE OF LABORATORY TESTING

1 Quarterly HOTLINE: Effective May 21, 2018. MEDICARE COVERAGE OF LABORATORY TESTING . Please remember when ordering LABORATORY tests that are billed to MEDICARE /Medicaid or other federally funded programs, the following requirements apply: 1. Only tests that are medically necessary for the diagnosis or treatment of the patient should be ordered. MEDICARE does not pay for screening tests except for certain specifically approved procedures and may not pay for non-FDA approved tests or those tests considered experimental. 2. If there is reason to believe that MEDICARE will not pay for a test, the patient should be informed. The patient should then sign an Advance Beneficiary Notice (ABN) to indicate that he or she is responsible for the cost of the test if MEDICARE denies payment. 3. The ordering physician must provide an ICD-10 diagnosis code or narrative description, if required by the fiscal intermediary or carrier. 4.

2 Organ- or disease-related panels should be billed only when all components of the panel are medically necessary. 5. Both ARUP- and client-customized panels should be billed to MEDICARE only when every component of the customized panel is medically necessary. 6. MEDICARE National Limitation Amounts for CPT codes are available through the Centers for MEDICARE &. Medicaid Services (CMS) or its intermediaries. Medicaid reimbursement will be equal to or less than the amount of MEDICARE reimbursement. The CPT Code(s) for test(s) profiled in this bulletin are for informational purposes only. The codes reflect our interpretation of CPT coding requirements, based upon AMA guidelines published annually. CPT codes are provided only as guidance to assist you in billing. ARUP strongly recommends that clients reconfirm CPT code information with their local intermediary or carrier. CPT coding is the sole responsibility of the billing party.

3 The regulations described above are only guidelines. Additional procedures may be required by your fiscal intermediary or carrier. Performed/Reported Schedule Specimen Requirements Other Interface Change Component Change Reference Interval Interpretive Data Hotline Page #. Name Change Test Number Methodology CPT Code New Test Inactive Note Summary of Changes by Test Name 3 0010003 ABO Group & Rh Type x 4 0060152 Acid-Fast Bacillus (AFB) Culture and AFB Stain x 4 0030056 ADAMTS13 Activity x 20 2007179 Allergen, Food, Artichoke IgE x 20 2001909 Allergen, Food, Currant Red, IgE x 4 0055145 Allergen, Tree, Pecan (Hickory) Tree x 4 2013601 Autoimmune Encephalitis Reflexive Panel x 4 2013944 Autoimmune Neurologic Disease Reflexive Panel x Page 1. Quarterly HOTLINE: Effective May 21, 2018. Performed/Reported Schedule Specimen Requirements Other Interface Change Component Change Reference Interval Interpretive Data Hotline Page #.

4 Name Change Test Number Methodology CPT Code New Test Inactive Note Summary of Changes by Test Name 4 0050141 C1-Esterase Inhibitor Functional x 20 0055565 Candida Antibody by ID x 5 2013798 Candida Species by PCR x 5 0080055 Carotene, Serum Total x 20 2003571 CD44 by Immunohistochemistry x 6 0025068 Chromium, Urine x x x 6 0050148 Complement Component 2 x Double-Stranded DNA (dsDNA) Antibody, IgG by 6 2002693. IFA (using Crithidia luciliae) x 7 3000453 14-3-3 eta Protein x Ethyl Glucuronide, Umbilical Cord Tissue, 8 3000443. Qualitative x 20 0091515 Fluoride Quantitative, Urine x Fluoxetine and Metabolite Quantitative, Serum or 8 2014180. Plasma x Genetic Carrier Screen, (CF, FXS, and SMA) with 9 3000258. Reflex to Methylation x 9 0070426 Hemoglobin A1c x x x x x 10 0020799 Hepatitis Delta Virus Antibody x Hepatitis Delta Virus Antibody with Reflex to 10 2013880. Hepatitis Delta Virus by Quantitative PCR x 10 2012023 Hepatitis E Virus (HEV) Antibodies, IgG and IgM x 10 2010151 Hepatitis E Virus (HEV) Antibody, IgG x 10 2010156 Hepatitis E Virus (HEV) Antibody, IgM x Human Immunodeficiency Virus 1 (HIV-1) by 10 2014234 Qualitative Transcription-Mediated Amplification (TMA) x Human Immunodeficiency Virus Type 1 (HIV-1).

5 10 0020284. Antibody Confirmation by Western Blot x Human Papillomavirus (HPV) Genotype 16 and 18. 11 3000414. by PCR, Head and Neck x 20 0070690 Insulin, Veterinary x Japanese Encephalitis Virus Antibodies, IgG and 11 2005689. IgM by ELISA x Japanese Encephalitis Virus Antibody, IgG by 12 2005687. ELISA x x Ketamine and Metabolite Quantitative, Serum or 12 0091507. Plasma x 12 3000440 KIT (D816V) Mutation by PCR x Page 2. Quarterly HOTLINE: Effective May 21, 2018. Performed/Reported Schedule Specimen Requirements Other Interface Change Component Change Reference Interval Interpretive Data Hotline Page #. Name Change Test Number Methodology CPT Code New Test Inactive Note Summary of Changes by Test Name 20 0040137 KIT (D816V) Mutation by PCR x 13 0092079 Magnesium, RBC x x 13 0025070 Manganese, Urine x x x 13 0060050 Microsporidia Stain by Modified Trichrome x x 14 0049302 Mismatch Repair by Immunohistochemistry x Mismatch Repair by Immunohistochemistry with 14 2002327 Reflex to BRAF Codon 600 Mutation and MLH1.

6 Promoter Methylation x Mismatch Repair by Immunohistochemistry with 14 2005270. Reflex to MLH1 Promoter Methylation x 14 3000352 Mucorales by PCR x Non-Criteria Antiphospholipid Syndrome (APS). 14 2012729. (aPs, aPt, aPs/aPt) Antibodies Panel x x 15 2002257 Osmotic Fragility, Erythrocyte x Ova and Parasite Exam, Fecal 15 2002272. (Immunocompromised or Travel History) x x 15 0060046 Parasitology Stain by Modified Acid-Fast x x PD-L1 22C3 IHC for Gastric/GEJ with 16 3000197. Interpretation, pembrolizumab (KEYTRUDA) x Ph-Like Acute Lymphocytic Leukemia (ALL) Panel 17 3000455. by FISH x 17 2014041 Potassium, Total, RBC x x 17 0051302 Prothrombin Antibody, IgG x x 18 3000460 Smith and RNP (U1) (ENA) Antibodies, IgG x 18 0099564 Strongyloides Antibody, IgG by ELISA, Serum x x x 19 2002736 Tramadol and Metabolite, Urine, Quantitative x x x Treponema pallidum (VDRL), Cerebrospinal Fluid 19 0050206. with Reflex to Titer x 0010003 ABO Group & Rh Type IRL-ABORH.

7 Specimen Required: Collect: Lavender (EDTA) or Pink (K2 EDTA). Specimen Preparation: Do not freeze red cells. Transport 3 mL whole blood. (Min mL). Pediatric: Transport mL (10 drops) whole blood. Storage/Transport Temperature: Refrigerated. Unacceptable Conditions: Separator tubes. Stability (collection to initiation of TESTING ): Ambient: 72 hours; Refrigerated: 1 week; Frozen: Unacceptable Page 3. Quarterly HOTLINE: Effective May 21, 2018. 0060152 Acid-Fast Bacillus (AFB) Culture and AFB Stain MC AFB. Specimen Required: Patient Prep: Recommended collection: Three sputum specimens at 8-24 hour intervals (24 hours when possible) and at least one first- morning specimen. An individual order must be submitted for each specimen. Collect: Respiratory specimens. Also acceptable: Body fluid, CSF, gastric aspirate, tissue, or urine. Specimen Preparation: Place each specimen in an individually sealed bag. Respiratory Specimens: Transfer (for each collection) 5-10 mL to a sterile container.

8 (Min: 1 mL). Body Fluids or CSF: Transfer 5 mL to a sterile container. (Min: 1 mL). Gastric Aspirates: Must be neutralized (pH7) with sodium carbonate if transport is delayed for more than four hours. Transfer 5-10. mL to a sterile container. (Min: 1 mL). Tissue: Transfer to a sterile container and place on gauze moistened with sterile non-bacteriostatic saline to prevent drying. (Min: Visible). Urine: Transfer at least 40 mL to a sterile container. (Min: 10 mL). Storage/Transport Temperature: Refrigerated. Remarks: Specimen source required. Unacceptable Conditions: Dry material or material collected and transported on a swab. Acid Fast Stain: Stool, blood, bone marrow, grossly bloody specimens, CSF if less than 5 mL, or urine specimens if less than 40 mL. Stability (collection to initiation of TESTING ): Ambient: 24 hours; Refrigerated: 1 week; Frozen: 1 week 0030056 ADAMTS13 Activity ADAMTS-13. Interpretive Data: ADAMTS13 levels of less than 10 percent may be associated with either inherited (Upshaw-Schulman Syndrome) or acquired thrombotic thrombocytopenic purpura (TTP).

9 A variety of medical conditions may result in a mild to moderate deficiency of ADAMTS13 activity. Recent plasma exchange therapy may raise the observed ADAMTS13 activity. See Compliance Statement D: 0055145 Allergen, Tree, Pecan (Hickory) Tree PECAN TREE. HOTLINE NOTE: Name change only. 2013601 Autoimmune Encephalitis Reflexive Panel AUTOENCEPH. CPT Code(s): 83519; 83516; 86255; 86341; if reflexed add 86255 x2, if further reflexed add 86256 per titer; if reflexed add 86256; if reflexed add 86255, if further reflexed add 86256. 2013944 Autoimmune Neurologic Disease Reflexive Panel NEURO R. CPT Code(s): 83519 x3; 83516 x3; 86255 x4; 86341; if reflexed add 86256; if reflexed add 86256; if reflexed add 86256; if reflexed add 86255 if further reflexed add 86256; if reflexed add 86255 x2 if further reflexed add 86256 per titer; if reflexed add 83516; if reflexed add 83516 and/or 86256. 0050141 C1-Esterase Inhibitor Functional C1 INH F.

10 Specimen Required: Collect: Serum Separator Tube (SST). Specimen Preparation: Separate from cells ASAP or within 2 hours of collection. Transfer mL serum to an ARUP Standard Transport Tube and freeze immediately. (Min: mL). Storage/Transport Temperature: CRITICAL FROZEN. Separate specimens must be submitted when multiple tests are ordered. Unacceptable Conditions: Non-frozen specimens. Stability (collection to initiation of TESTING ): After separation from cells: Ambient: 2 hours; Refrigerated: Unacceptable; Frozen: 2. weeks Page 4. Quarterly HOTLINE: Effective May 21, 2018. 2013798 Candida Species by PCR CANDPCR. Specimen Required: Collect: Body fluid, tissue, Lavender (EDTA), Pink (K2 EDTA), or pure isolate of Candida species on potato dextrose agar (PDA), sabouraud dextrose agar, sheep blood agar, chocolate agar, or inhibitory mold agar. Specimen Preparation: Body Fluid: Transfer 1 mL body fluid to a sterile container.