Medicare National And Local Coverage Determination Policy .

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Medicare National and Local Coverage Determination Policy- CT, MA, ME, NH, RI, VTPolicies in this MLCP Reference Guide apply to testing performed at a Quest Diagnostics facility and apply to Medicare National Coverage Determination Policy.This diagnosis code reference guide is provided as an aid to physicians and office staff in determining when an ABN (Advance Beneficiary Notice) is necessary.Diagnosis codes must be applicable to the patient’s symptoms or conditions and must be consistent with documentation in the patient’s medical record.Quest Diagnostics does not recommend any diagnosis codes and will only submit diagnosis information provided to us by the ordering physician or his/herdesignated staff. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billingparty. Please direct any questions regarding coding to the payer being billed. Click here for National MLCP Policies ToolDocument contains information on National MedicareLimited Coverage Policies Alpha-FetoproteinBlood CountsBlood Glucose TestingCarcinoembryonic AntigenCollagen Crosslinks - Any MethodDigoxin Therapeutic Drug AssayFecal Occult BloodGamma Glutamyl TransferaseGlycated Hemoglobin - Glycated ProteinHepatitis Panel/Acute Hepatitis PanelHuman Chorionic GonadotropinHuman Immunodeficiency Virus (HIV) Testing(Diagnosis)Human Immunodeficiency Virus (HIV) Testing(Prognosis Including Monitoring)Lipids TestingPartial Thromboplastin Time (PTT)Prostate Specific AntigenProthrombin Time (PT)Serum Iron StudiesThyroid TestingTumor Antigen by Immunoassay CA 15-3 CA 27.29Tumor Antigen by Immunoassay CA 19-9Tumor Antigen by Immunoassay CA-125Urine Culture, Bacterial Click here for Local MLCP Policies ToolDocument contains information on Medicare LocalLimited Coverage Policies for lab testing performed inCT, MA, ME, NH, RI, VT B-type Natriuretic Peptide (BNP) Testing Combined Ovarian Cancer Biomarker Tests Genomic Sequence Analysis Panels in the Treatment of Non-SmallCell Lung Cancer Heavy Metal Testing Molecular Pathology Procedures Non-covered Services RAST Type Tests Urine Drug Testing Vitamin D Assay TestingQuestDiagnostics.comQuest, Quest Diagnostics, any associated logos, and all associated Quest Diagnostics registered or unregistered trademarks are the property of Quest Diagnostics.All third party marks - and - are the property of their respective owners. 2016 Quest Diagnostics Incorporated. All rights reservedLast Updated:10/01/16

Medicare Local Coverage Determination Policy- CT, MA, ME, NH, RI, VTB-type Natriuretic Peptide (BNP) TestingData Source: Local Coverage Determination (LCD):CPT Code: 83880B-type Natriuretic Peptide (BNP) Testing (L33573)LCD Description: B-type natriuretic peptide (BNP) is a cardiac neurohormone produced mainly in the left ventricle. It is secreted in response to ventricular volume expansionand pressure overload, factors often found in congestive heart failure (CHF). Used in conjunction with other clinical information, rapid measurement of BNP is useful inestablishing or excluding the diagnosis and assessing the severity of CHF in patients with acute dyspnea so that appropriate and timely treatment can be initiated.ICD-10-CM Codes that Support Medical Necessity are listed, but it is not enough to link the procedure code to a correct payable ICD-10-CM code. The diagnosismust be present for the procedure to be paid and the procedure must be reasonable and medically necessary for that diagnosis. Documentation within the patient’s medicalrecord must support the medical necessity for the test(s) provided. This list was compiled from the Medicare Local Coverage Determination Policy. An ICD-10-CM bookshould be used as a complete reference.Table 1: ICD-10-CM codes that support medical necessity when billed ineither an office or outpatient setting.Group 1 Codes:E85.0 Non-neuropathic heredofamilial amyloidosisE85.1 Neuropathic heredofamilial amyloidosisE85.2 Heredofamilial amyloidosis, unspecifiedE85.3 Secondary systemic amyloidosisE85.4 Organ-limited amyloidosisE85.8 Other amyloidosisE85.9 Amyloidosis, unspecifiedI11.0 Hypertensive heart disease with heart failureI13.0 Hypertensive heart and chronic kidney disease with heart failure andstage 1 through stage 4 chronic kidney disease, or unspecified chronickidney diseaseI13.2 Hypertensive heart and chronic kidney disease with heart failure and withstage 5 chronic kidney disease, or end stage renal diseaseI50.1 Left ventricular failureI50.20 Unspecified systolic (congestive) heart failureI50.21 Acute systolic (congestive) heart failureI50.22 Chronic systolic (congestive) heart failureI50.23 Acute on chronic systolic (congestive) heart failureI50.30 Unspecified diastolic (congestive) heart failureI50.31 Acute diastolic (congestive) heart failureI50.32 Chronic diastolic (congestive) heart failureI50.33 Acute on chronic diastolic (congestive) heart failureI50.40 Unspecified combined systolic (congestive) and diastolic (congestive)heart failureI50.41 Acute combined systolic (congestive) and diastolic (congestive) heartfailureI50.42 Chronic combined systolic (congestive) and diastolic (congestive) 00R06.01R06.02R06.09R06.2R06.82R06.89R06.9Acute on chronic combined systolic (congestive) and diastolic (congestive)heart failureHeart failure, unspecifiedChronic obstructive pulmonary disease with acute lower respiratory infectionChronic obstructive pulmonary disease with (acute) exacerbationUnspecified asthma with (acute) exacerbationAcute bronchospasmDyspnea, unspecifiedOrthopneaShortness of breathOther forms of dyspneaWheezingTachypnea, not elsewhere classifiedOther abnormalities of breathingUnspecified abnormalities of breathingUtilization Guidelines: The use of BNP for monitoring CHF is not covered.Limitations: BNP measurements must be analyzed in conjunction with standard diagnostic tests,medical history and clinical findings. The efficacy of BNP measurement as a stand-alone test hasnot yet been established. Clinicians should be aware that certain conditions such as ischemia,infarction and renal insufficiency, may cause elevation of circulating BNP concentration andrequire alterations of the interpretation of BNP results.Additional investigation is required to further define the diagnostic value of plasma BNP inmonitoring the efficiency of treatment for CHF and in tailoring the therapy for heart failure.Therefore, BNP measurements for monitoring and management of CHF are not a covered service.Although a correlation between serum BNP levels and the clinical severity of HF has been shownin broad populations, “it cannot be assumed that BNP levels can be used effectively as targets foradjustment of therapy in individual patients. [T]he BNP measurement has not been clearly shownto supplement careful clinical assessment.” (Hunt SA, Abraham WT, Chin MH, et al. ACC/AHA2005 Guideline Update for the Diagnosis and Management of Chronic Heart Failure in the Adult: AReport of the American College of Cardiology/American Heart Association Task Force on PracticeGuidelines, pgs. 14-15)This list was compiled from Medicare’s Limited Coverage Policies for informational and reference purposes only. For the most current information please reference www.cms.gov.Note: If the patient’s medical record does not support one of the above ICD-10-CM codes, please prepare an Advance Beneficiary Notice form, and ask the patient to read and sign it.Source: Federal Registry Negotiated Rule-making, November 23, 2001“The cpt codes provided are based on ama guidelines and are for informational purposes only. Cpt coding is the sole responsibility of the billing party.Last Updated:Please direct any questions regarding coding to the payer being billed.”Quest, Quest Diagnostics, any associated logos, and all associated Quest Diagnostics registered or unregistered trademarks are the property of Quest Diagnostics.07/01/16All third party marks - and - are the property of their respective owners. 2016 Quest Diagnostics Incorporated. All rights reserved

Medicare Local Coverage Determination Policy- CT, MA, ME, NH, RI, VTCombined Ovarian Cancer Biomarker TestsData Source: Local Coverage Determination forCPT Code: 81500, 81503, 84999Combined Ovarian Cancer Biomarker Tests (L33588)LCD Description: OVA-1 is an ovarian cancer blood test that is reported to detect ovarian cancer in a pelvic mass. It is an aggregation of five biomarkers, beta 2microglobulin, apolipoprotein A-1, CA-125, transferrin and transthyretin. The Risk of Ovarian Malignancy Algorithm (ROMA ), is another test which combines the sametraditionally proven tumor marker, CA-125, with HE-4, human epidydimus protein 4, a relatively new protein marker produced by the over-expression of the gene WFDC2,and associated with epithelial ovarian neoplasia.ICD-10-CM Codes that Support Medical Necessity are listed, but it is not enough to link the procedure code to a correct payable ICD-10-CM code. The diagnosismust be present for the procedure to be paid and the procedure must be reasonable and medically necessary for that diagnosis. Documentation within the patient’smedical record must support the medical necessity for the test(s) provided. This list was compiled from the Medicare Local Coverage Determination Policy. An ICD-10-CMbook should be used as a complete reference.CPT/HCPCS CodesGroup 1 Paragraph: N/AGroup 1 Codes:81500 ONCOLOGY (OVARIAN), BIOCHEMICAL ASSAYS OF TWO PROTEINS (CA-125 AND HE4), UTILIZING SERUM, WITH MENOPAUSAL STATUS,ALGORITHM REPORTED AS A RISK SCORE81503 ONCOLOGY (OVARIAN), BIOCHEMICAL ASSAYS OF FIVE PROTEINS (CA-125, APOLIPOPROTEIN A1, BETA-2 MICROGLOBULIN, TRANSFERRIN,AND PRE-ALBUMIN), UTILIZING SERUM, ALGORITHM REPORTED AS A RISK SCORE84999 UNLISTED CHEMISTRY PROCEDUREICD-10 Codes that Support Medical NecessityGroup 1 Paragraph: N/AICD-10 Codes that DO NOT Support Medical Necessity N/AIndications and Limitations:Compliance with the provisions in this policy may be monitored and addressed through post payment data analysis and subsequent medical review audits.At the present time, National Government Services does not find either the OVA-1 or the ROMA test to be of proven efficacy in the diagnosis or treatment of ovariancancer. National Government Services will only allow coverage of CA-125 as allowed by the national coverage decision.This list was compiled from Medicare’s Limited Coverage Policies for informational and reference purposes only. For the most current information please reference www.cms.gov.Note: If the patient’s medical record does not support one of the above ICD-10-CM codes, please prepare an Advance Beneficiary Notice form, and ask the patient to read and sign it.Source: Federal Registry Negotiated Rule-making, November 23, 2001“The cpt codes provided are based on ama guidelines and are for informational purposes only. Cpt coding is the sole responsibility of the billing party.Last Updated:Please direct any questions regarding coding to the payer being billed.”Quest, Quest Diagnostics, any associated logos, and all associated Quest Diagnostics registered or unregistered trademarks are the property of Quest Diagnostics.10/01/15All third party marks - and - are the property of their respective owners. 2016 Quest Diagnostics Incorporated. All rights reserved

Medicare Local Coverage Determination Policy- CT, MA, ME, NH, RI, VTGenomic Sequence Analysis Panels in the TreatmentData Source: Genomic Sequence Analysis Panelsof Non-Small Cell Lung CancerCPT Code: 81445in the Treatment of Non-Small Cell Lung Cancer(L36376)LCD Description: Most lung cancers are epithelial in origin, with squamous cell carcinomas, adenocarcinomas, and small cell carcinomas being the predominant histologictypes. The first two, squamous and adenocarcinomas, have been traditionally grouped as non-small cell lung cancer (NSCLC). Surgery remains the cornerstone of treatmentfor early stage NSCLC of either type, however treatment of advanced stage disease is based primarily on drugs. Distinctive response patterns to specific therapeutic drugshave been demonstrated over the past 12 years, necessitating the distinction between squamous cell and adenocarcinoma morphology. Consequently the most recent WHOguidelines advocate sub-classification of all NSCLC in to a more specific subtype whenever possible. This is typically accomplished by histologic evaluation with support fromspecific immunohistochemical studies, which are particularly useful in the evaluation of small biopsies.ICD-10-CM Codes that Support Medical Necessity are listed, but it is not enough to link the procedure code to a correct payable ICD-10-CM code. The diagnosismust be present for the procedure to be paid and the procedure must be reasonable and medically necessary for that diagnosis. Documentation within the patient’s medicalrecord must support the medical necessity for the test(s) provided. This list was compiled from the Medicare Local Coverage Determination Policy. An ICD-10-CM bookshould be used as a complete reference.TARGETED GENOMIC SEQUENCE ANALYSIS PANEL, SOLID ORGAN NEOPLASM, DNAANALYSIS, AND RNA ANALYSIS WHEN PERFORMED, 5-50 GENES (EG, ALK, BRAF,CDKN2A, EGFR, ERBB2, KIT, KRAS, NRAS, MET, PDGFRA, PDGFRB, PGR, PIK3CA,PTEN, RET), INTERROGATION FOR SEQUENCE VARIANTS AND COPY NUMBERVARIANTS OR REARRANGEMENTS, IF 1C34.92C38.4C45.0Malignant neoplasm of tracheaMalignant neoplasm of unspecified main bronchusMalignant neoplasm of right main bronchusMalignant neoplasm of left main bronchusMalignant neoplasm of upper lobe, unspecified bronchus or lungMalignant neoplasm of upper lobe, right bronchus or lungMalignant neoplasm of upper lobe, left bronchus or lungMalignant neoplasm of middle lobe, bronchus or lungMalignant neoplasm of lower lobe, unspecified bronchus or lungMalignant neoplasm of lower lobe, right bronchus or lungMalignant neoplasm of lower lobe, left bronchus or lungMalignant neoplasm of overlapping sites of unspecified bronchus and lungMalignant neoplasm of overlapping sites of right bronchus and lungMalignant neoplasm of overlapping sites of left bronchus and lungMalignant neoplasm of unspecified part of unspecified bronchus or lungMalignant neoplasm of unspecified part of right bronchus or lungMalignant neoplasm of unspecified part of left bronchus or lungMalignant neoplasm of pleuraMesothelioma of pleuraIndications and Limitations of CoverageGenomic Sequential Analysis Panel represented by CPT 81445 will be consideredreasonable and necessary in the evaluation of tumor tissue in the following clinicalcircumstances: Newly diagnosed patients with advanced (stage IIIB or IV) NSCLC, who are nottreatable by resection or radiation with curative intent, and who are suitable candidatesfor therapy at the time of testing. Previously diagnosed patients with advanced (stage IIIB or IV) NSCLC, who have notresponded to at least one systemic therapy, or who have progressed followingresection. The patient must be a candidate for treatment at the time of the testing. Previously diagnosed patients with advanced (stage IIIB or IV) NSCLC, who havebeen resistant to at least one targeted therapy, are able to undergo tumor tissuebiopsy for testing, and who are suitable candidates for additional treatment at the timeof testing.Utilization GuidelinesScreening services such as pre-symptomatic genetic tests and services used to detectan undiagnosed disease or disease predisposition are not a Medicare benefit and arenot covered. Similarly, Medicare may not reimburse the costs of tests/examinationsthat assess the risk of a condition unless the risk assessment clearly and directlyeffects the management of the patient.This list was compiled from Medicare’s Limited Coverage Policies for informational and reference purposes only. For the most current information please reference www.cms.gov.Note: If the patient’s medical record does not support one of the above ICD-10-CM codes, please prepare an Advance Beneficiary Notice form, and ask the patient to read and sign it.Source: Federal Registry Negotiated Rule-making, November 23, 2001“The cpt codes provided are based on ama guidelines and are for informational purposes only. Cpt coding is the sole responsibility of the billing party.Last Updated:Please direct any questions regarding coding to the payer being billed.”Quest, Quest Diagnostics, any associated logos, and all associated Quest Diagnostics registered or unregistered trademarks are the property of Quest Diagnostics.4/01/16All third party marks - and - are the property of their respective owners. 2016 Quest Diagnostics Incorporated. All rights reserved

Medicare Local Coverage Determination Policy- CT, MA, ME, NH, RI, VTHeavy Metal Testing (pg. 1 of 10)Data Source: Local Coverage DeterminationCPT Codes: 82108, 82175, 82300, 82495, 82525, 83018,83655, 83785, 83825, 83885, 84255, 84285, 84630for Heavy Metal Testing (L35074)LCD Description: The term heavy metal testing is historically used to describe elements such as lead, arsenic, mercury, cadmium, and chromium. In general, all of the heavymetals in inorganic form cause GI irritation, resulting in nausea, vomiting, abdominal pain and diarrhea. The next most consistent toxicity for the heavy metals as a group, but notfor every heavy metal, is renal toxicity. A further generalization is that each member of the heavy metal group tends to cause multi-organ toxicity. Many metals cause cutaneousabnormalities, such as irritant and allergic contact dermatitis, urticaria, keratoses, and premalignant and malignant lesions. Several of the heavy metals produce central andperipheral nervous system toxicity. Other metals cause pulmonary illness. However, before any testing for heavy metal is ordered, a detailed medical history of the patient mustbe obtained, including a careful documentation of occupational and avocational exposure to these toxins. A complete physical examination must be done. While classified asheavy metals, this policy does not include iron or lithium since the former is typically tested for anemia issues and the latter is typically tested for monitoring of medications. Inaddition, iron testing is covered under the National Coverage Determination 190.18 (Serum Iron Studies).ICD-10-CM Codes that Support Medical Necessity are listed, but it is not enough to link the procedure code to a correct payable ICD-10-CM code. The diagnosis mustbe present for the procedure to be paid and the procedure must be reasonable and medically necessary for that diagnosis. Documentation within the patient’s medical recordmust support the medical necessity for the test(s) provided. This list was compiled from the Medicare Local Coverage Determination Policy. An ICD-10-CM book should beused as a complete reference.CPT 82108, Aluminum- Serum aluminum testing is payable for beneficiarieswho have been on dialysis with evidence suggesting aluminum toxicity, orfor beneficiaries with chronic industrial exposure ther specified mental disorders due to known physiological conditionOpioid abuse with intoxication deliriumOpioid abuse with intoxication with perceptual disturbanceOpioid abuse with opioid-induced mood disorderOpioid abuse with other opioid-induced disorderOpioid dependence with intoxication deliriumOpioid dependence with opioid-induced mood disorderOpioid dependence with other opioid-induced disorderOpioid use, unspecified with intoxication deliriumOpioid use, unspecified with intoxication, unspecifiedOpioid use, unspecified with opioid-induced mood disorderOpioid use, unspecified with other opioid-induced disorderCannabis abuse with intoxic

ICD-10-CM Codes that Support Medical Necessity are listed, but it is not enough to link the procedure code to a correct payable ICD-10-CM code. The diagnosis must be present for the procedure to be paid and the procedure must be reasonable and medically necessary for that diagnosis. Documentation within the patient’s medical

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