evekhm/cms_iom_3000 huggingface dataset:
Article - Billing and Coding: Arthroscopic Lavage and Arthroscopic Debridement for Osteoarthritic Knees (A54063)

CMS National Coverage PolicyN/AArticle TextThis article is being published to update the provider community on coverage for Arthroscopic Lavage and Arthroscopic Debridement for Osteoarthritic Knees.National Coverage Determination (NCD) 150.9 issued in 2004 describes Medicare coverage for Arthroscopic Lavage and Arthroscopic Debridement for Osteoarthritic Knees. In this NCD, non-covered indications are:Arthroscopic lavage used alone for the osteoarthritic kneeArthroscopic debridement for osteoarthritic patients presenting with knee pain only; or,Arthroscopic debridement and lavage with or without debridement for patients presenting with severe osteoarthritisCPT 29871  Arthroscopy, knee, surgical; for infection, lavage and drainage is used to describe the service covered by NCD 150.9.All other indications for coverage of arthroscopic lavage remain at Contractor discretion.Resources:NCD 150.9 Arthroscopic Lavage and Arthroscopic Debridement for the Osteoarthritic KneeCMS Change Request 3281
Article - Billing and Coding: Speech Language Pathology (SLP) Services: Communication Disorders (A54111)

CMS National Coverage PolicySocial Security Act (Title XVIII) Standard References:Title XVIII of the Social Security Act, Section 1833(e) states that no payment shall be made to any provider of services or other person under this part unless there has been furnished such information as may be necessary in order to determine the amounts due such provider or other person under this part for the period with respect to which the amounts are being paid or for any prior period.Article TextThis Billing and Coding Article provides billing and coding guidance for Local Coverage Determination (LCD) L35070 Speech-Language Pathology (SLP) Services: Communication Disorders. Please refer to the LCD for reasonable and necessary requirements.Coding Guidance:Notice:It is not appropriate to bill Medicare for services that are not covered (as described by the entire LCD) as if they are covered. When billing for non-covered services, use the appropriate modifier.When reporting services for speech generating devices the following Current Procedural Terminology (CPT) codes should be utilized:For selection and prescription report 92607For adaptation and training report 92609CPT does not define a specific re-evaluation code for speech language pathology; the evaluation code should be used.The group therapy CPT code 92508 should be reported when patients are not receiving direct one-on-one contact, but are being supervised by the therapist.Documentation Requirements:All documentation must be maintained in the patients medical record and made available to the contractor upon request.Every page of the record must be legible and include appropriate patient identification information (e.g., complete name, dates of service[s]). The documentation must include the legible signature of the physician or non-physician practitioner responsible for and providing the care to the patient.The submitted medical record must support the use of the selected ICD-10-CM code(s). The submitted CPT/HCPCS code must describe the service performed.
Article - Billing and Coding: MolDX: Afirma™ Assay by Veracyte Update (A54185)

CMS National Coverage PolicyN/AArticle TextThe MolDX Program contractor has completed the Afirma assessment and determined that the test meets criteria for analytical and clinical validity, and clinical utility as a reasonable and necessary Medicare benefit. Effective 10/01/2015, CGS Administrators and the MolDX Program contractor will reimburse Afirma services for patients with the following conditions(patient must have 1 and 2):1. Patients with one or more thyroid nodules with a history or characteristics suggesting malignancy such as:Nodule growth over timeFamily history of thyroid cancerHoarseness, difficulty swallowing or breathingHistory of exposure to ionizing radiationHard nodule compared with rest of gland consistencyPresence of cervical adenopathy2. Have an indeterminate follicular pathology on fine needle aspirationMolDX expects this test will be performed once per patient lifetime. Should the unlikely situation of a second, unrelated thyroid nodule with indeterminate pathology occur, coverage may be considered upon appeal with support documentation.To report an Afirma service, please submit the following claim information:Select the appropriate CPTcodeSelect the appropriate ICD-10-CM diagnosisEnter DEX Z-Code identifier adjacent to the CPT code in the comment/narrative field for the following Part B claim field/types:Loop 2400 or SV101-7 for the 5010A1 837PBox 19 for paper claimEnter DEX Z-Code identifier adjacent to the CPT code in the comment/narrative field for the following Part A claim field/types:Line SV202-7 for 837I electronic claimBlock 80 for the UB04 claim form
Article - Billing and Coding: MolDX: bioTheranostics Cancer TYPE ID® (A54188)

CMS National Coverage PolicyTitle XVIII of the Social Security Act, 1833(e) prohibits Medicare payment for any claim which lacks the necessary information to process the claim.CMS Internet-Only Manual, Pub. 100-02, Medicare Benefit Policy Manual, Chapter 15, 80.1.2 A/B MAC (B) Contacts With Independent Clinical LaboratoriesCMS Internet-Only Manual, Pub. 100-04, Medicare Claims Processing Manual, Chapter 16, 50.5 Jurisdiction of Laboratory Claims, 60.1.1 Independent Laboratory Specimen Drawing, 60.2 Travel AllowanceCMS Internet-Only Manual, Pub. 100-04, Medicare Claims Processing Manual, Chapter 23, 10 Reporting ICD Diagnosis and Procedure CodesArticle TextEffective November 19, 2012, Cancer TYPE ID, an RT-PCR 92-gene assay, has been assigned a DEX Z-Code identifier. To bill for Cancer TYPE ID, please provide the following claim information:CPT code: 81540- Oncology (tumor of unknown origin) mRNA gene expression of 92 genesEnter 1 in the Days/Unit fieldEnter DEX Z-Code Identifier in the comment/narrative field for the following claim field/types:Loop 2300 NTE01/SV202-7 for Part A or SV101-7 field for Part BSubmit DEX Z-Code Identifier on an attachment to the claim form for paper claim (Form locator 80 for Part A or Box 19 for Part BSelect the appropriate ICD-10-CM code:Note: MolDX expects this test to ONLY be ordered by the treating physician.
Article - Billing and Coding: MolDX: cobas® EGFR Mutation Test Guidelines (A54189)

CMS National Coverage PolicyN/AArticle TextEffective for dates of service on and after 5/14/13, CGS Administrators and the MolDX program contractor will cover the FDA approved, cobas EGFR Mutation Test for the detection of epidermal growth factor receptor (EGFR) gene for non-small cell lung cancer (NSCLC) tumor tissue. The test is intended to be used to help select patients with NSCLC for whom Tarceva (erlotinib), an EGFR tyrosine kinase inhibitor (TKI), is indicated.To report a cobas service, please submit the following claim information:CPT code 81479  Unlisted chemistry procedureEnter ZBA66 in the comment/narrative field for the following claim field/types:Loop 2300 NTE01 for part A or Loop 2400 NTE02/SV 101-7 for Part BSubmit ZBA66 on an attachment to the claim form for paper claim(Form locator 80 fro Part A or Box 19 for Part B)Select at least one ICD-10-CM diagnosis code from the following tables for dates of service on and after 10/01/2015C34.11 Malignant neoplasm of upper lobe, right bronchus or lungC34.12 Malignant neoplasm of upper lobe, left bronchus or lungC34.2 Malignant neoplasm of middle lobe, bronchus or lungC34.31-Malignant neoplasm of lower lobe, right bronchus or lungC34.32-Malignant neoplasm of lower lobe, left bronchus or lungC34.81-Malignant neoplasm of overlapping sites of right bronchus and lungC34.82-Malignant neoplasm of overlapping sites of left bronchus and lungC34.91-Malignant neoplasm of unspecified part of right bronchus or lungC34.92-Malignant neoplasm of unspecified part of left bronchus or lungNOTE:CGS and the MolDX Program contractor will apply NPI to ID editing. All labs that submit claims for the cobas EGFR kitMUSTregister the test and confirm theUNMODIFIEDuse of the kit. For lab developed tests (LDT) or tests that modify the cobas EGFR kit, CPT code 81235 should be reported and submitted with the assigned LDT test ID.
Article - Billing and Coding: MolDX: FDA-Approved BRAF Tests (A54191)

CMS National Coverage PolicyTitle XVIII of the Social Security Act, 1833(e) prohibits Medicare payment for any claim which lacks the necessary information to process the claim.Article TextTwo tests have met the FDA criteria for BRAF genetic testing:Effective 09/07/2012cobas 4800 BRAF V600to detect the presence of a mutation in the BRAF gene in melanoma cells and determine if a patient is eligible for Zelboraf (vemurafenib), a treatment indicated for a melanoma that cannot be surgically excised or has spread in the body.Effective 5/29/13ThxID BRAF V600/Kto detect the BRAF V600E and V600K mutations in selecting melanoma patients whose tumors carry the BRAF V600E mutation for treatment with dabrafenib [Tafinlar] and as an aid in selecting melanoma patients whose tumors carry the BRAF V600E or V600K mutation for treatment with trametinib [Mekinist].To report an FDA approved or laboratory developed test (LDT) BRAF V600 test kit service, please submit the following claim information:CPTcode 81210Enter the appropriate DEX Z-Codeidentifier adjacent to the CPTcode in the comment/narrative field for the following Part B claim field/types:Loop 2400 or SV101-7 for the 5010A1 837PBox 19 for paper claimEnter the appropriate DEX Z-Codeidentifier adjacent to the CPTcode in the comment/narrative field for the following Part A claim field/types:Line SV202-7 for 837I electronic claimBlock 80 for the UB04 claim formSelect the appropriate ICD-10-CM diagnosis.NOTE: MolDX will apply NPI to ID editing on FDA approved BRAF kits. All labs that submit claims for a BRAF V600 test kitMUSTregister the test and confirm theUNMODIFIEDuse of the kit. Tests may be registered on the DEX Diagnostics Exchangehttps://app.dexzcodes.com/login.This article reflects the FDA-approved indications on article creation date. MolDX will allow future FDA approved and amended indications for these tests.
Article - Billing and Coding: MolDX: FDA-Approved EGFR Tests (A54192)

CMS National Coverage PolicyTitle XVIII of the Social Security Act, 1833(e) prohibits Medicare payment for any claim which lacks the necessary information to process the claim.Article TextTwo tests have met the FDA criteria for EGFR genetic testing:Effective 06/01/2016cobas EGFR Mutation Testis a real-time PCR test for the qualitative detection of defined mutations of the epidermal growth factor receptor (EGFR) gene in non-small cell lung cancer (NSCLC) patients. Defined EGFR mutations are detected using DNA isolated from formalin-fixed paraffin-embedded tumor tissue (FFPET) or circulating-free tumor DNA (cfDNA) from plasma derived from EDTA anti-coagulated peripheral whole blood.The test is indicated as a companion diagnostic to aid in selecting NSCLC patients for treatment with the targeted therapies listed in the Table below in accordance with the approved therapeutic product labeling:Patients with positive cobas EGFR Mutation Test v2 test results using plasma specimens for the presence of EGFR exon 19 deletions or L858R mutations are eligible for treatment with TARCEVA (erlotinib). Patients who are negative for these mutations by this test should be reflexed to routine biopsy and testing for EGFR mutations with the FFPET sample type.Effective 7/12/13therascreen EGFR RGQPCR kit for the detection of the epidermal growth factor receptor (EGFR) gene for non-small cell lung cancer (NSCLC) tumor tissue to help select patients with NSCLC for whom GILOTRIF (afatinib), an EGFR tyrosine kinase inhibitor (TKI), is indicated.DrugFFPETPlasmaTARCEVA  (erlotinib)Exon 19 deletions and L858RExon 19 deletions and L858RTAGRISSO  (osimertinib)T790MTo report an FDA approved or laboratory developed test (LDT) EGFR test kit service, please submit the following claim information:CPTcode: 81235Enter the appropriate DEX Z-Code identifier adjacent to the CPTcode in the comment/narrative field for the following Part B claim field/types:Loop 2400 or SV101-7 for the 5010A1 837PBox 19 for paper claimEnter the appropriate DEX Z-Code identifier adjacent to the CPTcode in the comment/narrative field for the following Part A claim field/types:Line SV202-7 for 837I electronic claimBlock 80 for the UB04 claim formICD-10-CM codesNOTE:MolDX will apply NPI to ID editing on FDA approved EGFR kits. All labs that submit claims for an EGFR kitMUSTregister the test and confirm theUNMODIFIEDuse of the kit. Tests may be registered on the McKesson Diagnostics ExchangeTM: https://app.mckessondex.com/#/loginFor lab developed tests (LDT) or tests that modify an EGFR test, CPT code 81235 and NO modifier should be reported and submitted with the assigned LDT test ID.This article reflects the FDA-approved indications on article creation date. MolDX will allow future FDA approved and amended indications for these tests.
Article - Billing and Coding: MolDX: MammaPrint (A54194)

CMS National Coverage PolicyN/AArticle TextMammaPrint is a diagnostic test that analyzes the gene expression profile of FFPE breast cancer tissue samples to assess a patients' risk for distant metastasis.The test can be performed using either a FDA-cleared in vitro microarray assay or a next generation sequencing (NGS)-based assay. Each assay has been assigned a unique Z-code identifier in the DEX Registry.MammaPrintwas prospectively validated as a microarray assay in the 6,693 patient MINDACT trial in early stage breast cancer, <5cm up to 3 positive lymph nodes and independent of receptor status. The MammaprintNGS test has demonstrated technically equivalent performance to the predicate microarray test.To bill for MammaPrintservices, submit the following claim information:Enter 1 in the Days/Unit fieldFor CPTnon-NOC codes, Labs may either use the SV101-7 or SV202-7 (preferred) or the NTE field to submit this required information. For dates of service on or after 1/1/2022, use CPT code 81523 for the test if performed by NGS.Enter the appropriate DEX Z-Code identifier adjacent to the CPTcode in the comment/narrative field for the following Part B claim field/types:Loop 2400 or SV101-7 for the 5010A1 837PBox 19 for paper claimEnter the appropriate DEX Z-Code identifier adjacent to the CPTcode in the comment/narrative field for the following Part A claim field/types:Line SV202-7 for 837I electronic claimBlock 80 for the UB04 claim formOnly one test- NGS or microarray may be performed on a given date of service for a given patient.Note:MolDX expects this test may be performed upon occasion twice per patient lifetime for bilateral disease. Should a patient experience an additional occurrence, coverage may be considered with supporting documentation through the appeal process.
Article - Billing and Coding: MolDX: Oncotype DX® Breast Cancer Assay (A54195)

CMS National Coverage PolicyN/AArticle TextNOTE:The Oncotype DX Breast Cancer Assay and the Oncotype DX DCIS Score are different tests and should NOT be submitted with the same Z-Code Identifier. Because this article ONLY addresses Oncotype DX Breast, the diagnosis codes for breast carcinoma in situ have been removed.Oncotype DX & reg Breast was developed for patients with the following findings:estrogen-receptor positive, node-negative carcinoma of the breastestrogen-receptor positive micrometastases of carcinoma of the breast, andestrogen-receptor positive breast carcinoma with 1-3 positive nodesTo bill an Oncotype Breast service, please provide the following claim information:CPTcode 81519  Oncology (breast)Enter 1 in the Days/Unit fieldSelect the appropriate ICD-10-CM code.Enter DEX Z-Code identifier adjacent to the CPTcode in the comment/narrative field for the following Part B claim field/types:Loop 2400 or SV101-7 for the 5010A1 837PBox 19 for paper claimEnter DEX Z-Code identifier adjacent to the CPTcode in the comment/narrative field for the following Part A claim field/types:Line SV202-7 for 837I electronic claimBlock 80 for the UB04 claim form
Article - Billing and Coding: MolDX: Oncotype DX® Colon Cancer Assay Update (A54196)

CMS National Coverage PolicyN/AArticle TextThe Oncotype DX&reg Colon Cancer Assay, developed to predict the recurrence risk for patients with Stage II colon cancer, has been assigned a unique identifier. To bill an Oncotype DX Colon service, please provide the following claim information:CPT code 81525-Oncology (colon), mRNA gene expression of 21 genesEnter 1 in the Days/Unit fieldFor CPT non-NOC codes, Labs may either use the SV101-7 or SV202-7 (preferred) or the NTE field to submit this required information.Enter the appropriate DEX Z-Code identifier adjacent to the CPT code in the comment/narrative field for thefollowing Part B claim field/types:Loop 2400 or SV101-7 for the 5010A1 837PBox 19 for paper claimEnter the appropriate DEX Z-Code identifier adjacent to the CPT code in the comment/narrative field for the following Part A claim field/types:Line SV202-7 for 837I electronic claimBlock 80 for the UB04 claim formSelect the appropriate ICD-10-CM code:
Article - Billing and Coding: MolDX: Progensa® PCA3 Assay Coverage Update (A54197)

CMS National Coverage PolicyN/AArticle TextProgensa PCA3 Assay, an FDA approved test by Gen-Probe Incorporated, is an mRNA expression assay used alone or in combination with other molecular tests for prostate cancer determination to identify patients with increased risk of prostate cancer. PCA3 may help to improve the specificity of prostate cancer detection providing additional information about the risk of prostate cancer over the use of the PSA test alone. Based on the ratio of PCA3 mRNA/PSA mRNA x1000, the PCA3 assay is performed on the first urine collected following an attentive digital rectal examination. PCA3 testing is coveredONLYwhen all biopsies in previous encounter(s) are negativeandwhen the patient or physician wants to avoid repeat biopsy (watchful waiting). When the physician plans to biopsy the prostate, MolDX will consider a PCA3 test as investigational and thus, not a covered Medicare benefit. MolDX considers all other indications for PCA3 not reasonable and necessary. Medical record documentation must indicate the rationale to perform a PCA3 assay. Providers who report a PCA3 service AND perform a biopsy may be referred for additional action. To report a PCA3 service, submit the following claim information:Enter CPTcode 81313 - PCA3/KLK3For CPTnon-NOC codes, Labs may either use the SV101-7 or SV202-7 (preferred) or the NTE field to submit this required information.Enter the appropriate DEX Z-Codeidentifier adjacent to the CPTcode in the comment/narrative field for the following Part B claim field/types:Loop 2400 or SV101-7 for the 5010A1 837PBox 19 for paper claimEnter the appropriate DEX Z-Codeidentifier adjacent to the CPTcode in the comment/narrative field for the following Part A claim field/types:Line SV202-7 for 837I electronic claimBlock 80 for the UB04 claim formSelect the appropriate ICD-10-CM diagnosisNOTE:Effective 10/15/2012, MolDX will deny all laboratory developed tests (LDT) for PCA3 as statutorily excluded services that do not support the required clinical utility for the established Medicare benefit category. Only the unmodified FDA approved test, will be reimbursed.
Article - Billing and Coding: MolDX: ResponseDX Tissue of Origin® (A54198)

CMS National Coverage PolicyN/AArticle TextTissue of Origin, a microarray-based gene expression assay designed to determine the similarity of unknown or unresolved tumors to cancers from 1 of 15 known tumors of origin, has been assigned a unique identifier. To bill for Tissue of Origin services, please provide the following claim information:CPTcode 81504  Oncology (tissue of origin)Enter 1 in the Days/Unit fieldSelect the appropriate ICD-10-CM diagnosis.Enter DEX Z-Code identifier adjacent to the CPTcode in the comment/narrative field for the following Part B claim field/types:Loop 2400 or SV101-7 for the 5010A1 837PBox 19 for paper claimEnter DEX Z-Code identifier adjacent to the CPTcode in the comment/narrative field for the following Part A claim field/types:Line SV202-7 for 837I electronic claimBlock 80 for the UB04 claim formNote: MolDX expects this test to ONLY be ordered by the treating physician.
Article - Billing and Coding: MolDX: Therascreen® EGFR RGQ PCR Kit Guidelines (A54199)

CMS National Coverage PolicyN/AArticle TextEffective for dates of service on and after 7/12/13, CGS Administrators and the MolDX Program contractor will cover the FDA approved, therascreen EGFR RGQ PCR kit for the detection of the epidermal growth factor receptor (EGFR) gene from non-small cell lung cancer (NSCLC) tumor tissue. The test is intended to be used to select patients with NSCLC for whom GILOTRIF (afatinib), an EGFR tyrosine kinase inhibitor (TKI), is indicated.To report a therascreen EGFR service, please submit the following claim information:CPT code 81479  Unlisted chemistry procedureEnter ZBZ25 in the comment/narrative field for the following claim field/types:Loop 2300 NTE01 for Part A or Loop 2400 NTE02/SV 101-7 for Part BSubmit ZBZ25 on an attachment to the claim form for paper claim (Form locator 80 for Part A or Box 19 for Part B)For dates of service (DOS) on or after 10/01/2015, select the appropriate ICD-10-CM diagnosis from the following list:C34.11 Malignant neoplasm of upper lobe, right bronchus or lungC34.12 Malignant neoplasm of upper lobe, left bronchus or lungC34.2 Malignant neoplasm of middle lobe, bronchus or lungC34.31-Malignant neoplasm of lower lobe, right bronchus or lungC34.32-Malignant neoplasm of lower lobe, left bronchus or lungC34.81-Malignant neoplasm of overlapping sites of right bronchus and lungC34.82-Malignant neoplasm of overlapping sites of left bronchus and lungC34.91-Malignant neoplasm of unspecified part of right bronchus or lungC34.92-Malignant neoplasm of unspecified part of left bronchus or lungNOTE:CGS and the MolDX Program will apply NPI to ID editing. All labs that submit claims for the therascreen EGFR kitMUSTregister the test and confirm theUNMODIFIEDuse of the kit. For lab developed tests (LDT) or tests that modify the therascreen EGFR kit, CPT code 81235 should be reported and submitted with the assigned LDT test ID.
Article - Billing and Coding: MolDX: MMACHC Test (A54209)

CMS National Coverage PolicyTitle XVIII of the Social Security Act, 1862(a)(1)A) allows coverage and payment for only those services that are considered to be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body memberArticle TextMethylmalonic aciduria (cobalamin deficiency) cblC type, with homocystinuria (MMACHC) is associated with the most common error of vitamin B12 metabolism. Although considered a disease of infancy or childhood, some individuals develop symptoms in adulthood. However to date, the exact function of the protein encoded by this gene is not known. Therefore, MMACHC testing does not meet the clinical utility requirements for a Medicare Benefit and is considered a statutorily excluded service. CGS Administrators and the MolDX Program contractor will also deny panels of tests that include the MMACHC gene.To receive a MMACHC service denial, please submit the following claim information:CPTcode 81404-MMACHC, fgsAn Advance Beneficiary Notice (ABN) is not required for statutorily excluded services.For a voluntary issued ABN, append with GX modifierTo indicate a valid ABN is on file for a known statutorily excluded service, append with a GY modifierEnter the appropriate DEX Z-code identifier adjacent to the CPTcode in the comment/narrative field for the following claim field/types:Loop 2300 NTE01/SV202-7 for Part A or Loop 2400 NTE02/SV 101-7 for Part BForm locator 80 for Part A or Box 19 for Part B on paper claim