evekhm/cms_iom_500 huggingface dataset:
Article - Billing and Coding: MolDX: FANCC Genetic Testing (A53628)
CMS National Coverage PolicyTitle XVIII of the Social Security Act (SSA), 1862(a)(1)(A), states that no Medicare payment shall be made for items or services that are not reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member.Article TextEffective for dates of service on and after February 6, 2013FANCC gene testing is performed in association with Fanconi anemia (FA), a condition characterized by physical abnormalities, bone marrow failure, and increased risk of malignancy. For infants and children, FANCC genetic testing is used to confirm the clinical findings, such as blood counts and bone marrow biopsy, to diagnose FA. Genetic testing for adults is used to screen potential carriers of the mutation. Therefore, the MolDX Team has determined that testing for the FANCC is not a Medicare benefit and is a statutorily excluded service. In addition to single gene testing, MolDX will also deny panels of tests that include the FANCC gene.To receive a FANCC test denial, please submit the following claim information:CPTcode 81242- FANCC, common variantCPTcode 81412  Ashkenazi Jewish Associated DisorderCPTcode 81443  Genetic testing for severe inherited conditionsAn 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 modifierFor 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 form
Article - Billing and Coding: MolDX: MCOLN1 Genetic Testing (A53630)
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 TextEffective for dates of service on and after February 6, 2013Mutations found in mucolipin 1 (MCOLN1) are associated with Mucolipidosis, type IV, a disease characterized by psychomotor event delay in children evident before the first year of life. For infants and children, MCOLN1 genetic testing is used to confirm the clinical findings to diagnose Mucolipidosis. Genetic testing for adults is used to screen the population for potential carriers of the mutation. Therefore, the MolDX Team has determined that MCOLN1 genetic testing is not a Medicare benefit and is a statutorily excluded service. In addition to single gene testing, MolDX will also deny panels of tests that include a MCOLN1 gene test as a statutorily excluded service.To receive a MCOLN1 test denial, please submit the following claim information:CPTcode 81290,81412, or 81443An Advance Beneficiary Notice (ABN) is not required for statutorily excluded servicesFor a voluntary issued ABN, append with GX modifierTo indicate a statutorily excluded service, append with a GY modifierEnter 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 form
Article - Billing and Coding: MolDX: Fragile X (A53638)
CMS National Coverage PolicyTitle XVIII of the Social Security Act, 1862(a)(1)(A) statutory exclusion covers diagnostic testing "except for items and services that are not reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member".Article TextEffective for dates of service on and after 01/1/2013The MolDX Team has determined that Fragile X testing is not a Medicare covered service. Screening in the absence of signs and symptoms of an illness or injury is not defined as a Medicare benefit. Therefore, MolDX will deny testing for Fragile X as a statutorily excluded service.To receive a Fragile X service denial, please submit the following claim information:Select the appropriate CPTcode:81243- FMR181244- FMR1, methylation analysis81470  X-linked intellectual disability genomic sequence analysis panel81471  X-linked intellectual disability genomic sequence analysis panel duplication / deletionAn 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 modifierFor 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 formNOTE:When entering the DEX Z-Codeon the SV101-7 documentation field for Part B claims please do not add additional characters and/or information on the line.
Article - Billing and Coding: MolDX: ApoE Genotype (A53652)
CMS National Coverage PolicyTitle XVIII of the Social Security Act, 1862(a)(1)(A) statutory exclusion covers diagnostic testing "except for items and services that are not reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member".Article TextThe MolDX Team has determined Apolipoprotein (Apo) E genotype testing, developed to assess the risk of cardiovascular disease, has insufficient evidence to support the required clinical utility for the established Medicare benefit category.As reviewed, the developers described the indication to perform an Apolipoprotein (Apo) E genotype test as a risk assessment for developing a disease or condition. Risk assessment for developing a disease or condition in the absence of signs and symptoms of an illness or injury is also not defined as a Medicare benefit. Therefore, Apolipoprotein (Apo) E genotype tests used for that purpose would continue to be statutory excluded tests.To receive an ApoE service denial, please submit the following claim information:CPTcode 81401- APOE, common variantAn Advance Beneficiary Notice (ABN) is not required for statutorily excluded servicesFor a voluntary issued ABN, append with GX modifierTo indicate a statutorily excluded service, append with a GY modifierEnter 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 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 form
Article - Billing and Coding: MolDX: 9p21 Genotype Test (A53657)
CMS National Coverage PolicyTitle XVIII of the Social Security Act, 1862(a)(1)(A) statutory exclusion covers diagnostic testing "except for items and services that are not reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member".Article TextThe MolDX Team has completed a review on the 9p21 Genotype test. To date, there is insufficient evidence to support the required clinical utility for the established Medicare benefit category. Therefore, the 9p21 test is a statutorily excluded test.To receive a 9p21 service denial, please submit the following claim information:CPTcode 81479An Advance Beneficiary Notice (ABN) is not required for statutorily excluded servicesFor a voluntary issued ABN, append with GX modifierTo indicate a statutorily excluded service, append with a GY modifierEnter 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: L1CAM Gene Sequencing (A53659)
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 TextEffective for dates of service on and after January 29, 2013L1 syndrome refers to multiple disorders including X-linked hydrocephalus with aqueduct of Sylvius (HSAS) stenosis, MASA syndrome (Mental retardation, Aphasia, Spastic paraplegia, Adducted thumbs), SPG1 (X-linked complicated hereditary spastic paraplegia type 1), and X-linked complicated corpus callosum agenesis. Because there are many potential underlying causes for congenital hydrocephalus, including syndromic and nonsyndromic cases, recurrence risk and implications for family members is based upon underlying etiology. Genetic testing of the L1CAM gene is used to confirm a clinical diagnosis and provide recurrence risk. Therefore, the MolDX Team has determined L1CAM full gene sequencing is a statutorily excluded test.To receive a L1CAM gene sequencing service denial, please submit the following claim information:CPT code 81407-L1CAMCPT code 81470- X-linked intellectual disability genomic sequence analysis panelCPT code 81471- X-linked intellectual disability genomic sequence analysis panel duplication / deletionFor 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 modifierAn Advance Beneficiary Notice (ABN) is not required for statutorily excluded servicesEnter 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: PAX6 Gene Sequencing (A53664)
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 TextEffective for dates of service on and after January 29, 2013PAX6 is most frequently associated with PAX6-associated aniridia and WAGR syndrome (predisposition to Wilms tumor, Aniridia, Genitourinary anomalies and mental Retardation). Because FISH probes are reported to detect 100% of the WAGR syndrome cases, FISH probes represent the gold standard for patient diagnosis. Although PAX6 sequencing will identify the underlying genetic mutation leading to the development of aniridia in approximately 50% of individuals with sporadic disease, the remaining 50% will have negative test results. Therefore, the MolDX Team has determined PAX6 gene sequencing does not support the required clinical utility for the established Medicare benefit category and is a statutorily excluded test.To receive a PAX6 gene sequencing service denial, please submit the following claim information:CPTcode 81479An Advance Beneficiary Notice (ABN) is not required for statutorily excluded servicesFor a voluntary issued ABN, append with GX modifierTo indicate a statutorily excluded service, append with a GY modifierEnter 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: Mitochondrial Nuclear Gene Tests (A53669)
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 TextEffective for dates of service on and after January 29, 2013.Mitochondrial disorders are a group of conditions caused by dysfunction in the mitochondrial respiratory chain. Current genetic testing methods are unable to detect mutations in all individuals with suspected mitochondrial disease, and there is no proven effective treatment for persons with a known mitochondrial disease. Therefore, the MolDX Team has determined mitochondrial nuclear gene tests do not support the required clinical utility for the established Medicare benefit category and are statutorily excluded tests.To receive a mitochondrial nuclear panel service denial, please submit the following claim information:CPTcode 81479- Unlisted molecular pathology procedureAn Advance Beneficiary Notice (ABN) is not required for statutorily excluded servicesFor a voluntary issued ABN, append with GX HCPCS modifierTo indicate a statutorily excluded service, append with a GY HCPCS modifierEnter DEX Z-Code identifier adjacent to the CPTcode in the comment/narrative field for the following Part B claim field/typesLoop 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 for
Article - Billing and Coding: MolDX: SEPT9 Gene Test (A53702)
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 TextThe MolDX team has determined that a Septin 9 methylation analysis test for colorectal cancer detection is not a Medicare covered service. Screening in the absence of signs and symptoms of an illness or injury is not defined as a Medicare benefit. Therefore, MolDX will deny Septin 9 methylation analysis tests as a statutorily excluded service.To receive a SEPT9 service denial, please submit the following claim information:81327- SEPT9 (Septin9) (e.g., colorectal cancer) methylation analysis.An Advance Beneficiary Notice (ABN) is not required for statutorily excluded servicesFor a voluntary issued ABN, append with GX modifierTo indicate a statutorily excluded service, append with a GY modifierEnter 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: Lab: Immunohistochemistry (IHC) Indications for Breast Pathology (A53704)
CMS National Coverage PolicyTitle XVIII of the Social Security Act, 1833(e), prohibits Medicare payment for any claim lacking the necessary documentation to process the claim.Article TextBased on recommendations from the College of American Pathologists, the American Society of Clinical Oncologists (ASCO), and the National Comprehensive Cancer Network (NCCN), hormone receptor assays, estrogen receptor (ER), progesterone receptor (PR), and Her-2/neu are the only current biomarkers that demonstrate standardized value in breast cancer pathology evaluation. Although other biomarkers, such as Ki-67, PI3K, and gene expression assays, have been studied, no proven standardized value has been established. Therefore, this A/B MAC will allow ER, PR, and Her2 testing by IHC for patients with primary invasive breast cancers and recurrent or metastatic cancers.To report an IHC service for an ER, PR, Her2, submit the following claim information:CPTCodeSpecimenUOS88342First single/multiplex stain188341Each additional2To report morphometric analysis,select oneof the following codes based on the type of morphometric analysis:CPTCodeService TypeUOS88360Manual388361Computer-assisted3Note: a unit of service applies to a single separately identifiable specimen.
Article - Billing and Coding: External Components for Cochlear Implants (A53708)
CMS National Coverage PolicyN/AArticle TextA cochlear implant system consists of both internal (implanted) and external components. The external components consist of a microphone, sound processor and a transmitter.Replacement of cochlear implant components not otherwise covered under a manufacturer's warranty:There are very few mechanical problems associated with cochlear implants, and replacement of existing components due to device failure occurs infrequently. However, there have been many revisions and upgrades to the various components leading to improvements in design and speech perception. Replacement of an existing, functioning cochlear implant component is covered only when a physician certifies that:The existing component is ineffective to the point of interfering with the activities of daily living, orWhen there is a change in the patient's medical condition necessitating a different type of component, orThe existing component has reached its reasonable useful life. The reasonable useful life of a sound processor is not less than 5 years.Replacement or upgrades of existing, functioning cochlear implants or cochlear implant components for any reason before the component has reached its reasonable useful life are not covered by Palmetto GBA. For example, upgrading to next generation, smaller profile external components, or switching from a body worn sound processor to a behind-the-ear model is considered a convenience.Supplies or accessories that are not necessary for the functioning of the cochlear implant, such as cell phone adapters, telecoils, carrying cases, keychain wallets, or car charger adapters, and accessories and upgrades to accommodate personal convenience or deluxe items are not covered by Palmetto GBA. Accessories and supplies should be reported with HCPCS code L9900.When replacing headset/headpiece, microphone, transmitting coil or transmitter cable for use with cochlear implant device, the correct HCPCS code should be used instead of L7510.
Article - Billing and Coding: External Components for Cochlear Implants (A53708)
When replacing headset/headpiece, microphone, transmitting coil or transmitter cable for use with cochlear implant device, the correct HCPCS code should be used instead of L7510.When a repair is being done on a prosthetic device, the labor component is billed with HCPCS code L7520. Each billable unit represents 15 minutes of labor time. Documentation should include the original purchase date of the item repaired, the reason for repair, the item repaired, the functionality of the item repaired and the invoice cost from the manufacturer. The specific items repaired should be documented with invoice cost and the specific parts repaired. Repairs and replacement of minor parts and pieces can be billed under code L7510. Replacement items can be billed under L7510 if no other code is suitable.DO NOT BILL ACCESSORIESunder code L7510. Labor cost does not apply when items are being replaced.Battery Quantity Limit Per ImplantHCPCS CodePer MonthPer 3 MonthsOtherL86213090N/AL862260180N/AL8623N/AN/A4 per 12 monthsL8624N/AN/A4 per 36 monthsFor any exceptions please submit the appropriate narrative in item #19 claim field of the electronic 5010 form or on an attachment for paper claims.Following is an example of items classified as convenience and not necessary for the functionality of the Cochlear Implant device and are considered an accessory to be billed under code L9900:Attachment/Connection/Safety ClipsAudio Interface DeviceCar AdaptersCable AdaptersEar Hook PinsDaCapo Extension KitsDrying supplies - Manual/ElectricalFine Tuner/Fine Tuner BatteriesFixation BarMini Battery PacksMicrophone Tester Device KitDevice ProtectorsRemote Battery PacksRepair KitsTelephone AdapterT Mic MicrophoneFollowing is an example of items that are considered a major part of the device and should be billed under the specific L code listed in theCPT/HCPCS Codetable provided below:BatteriesCablesCoilsControllersHeadsetsMicrophonesProcessorsThe following items are considered a major part of the device and would be replaced every three years for reasonable use:Battery ChargersBattery PacksEar HookMicrophone coverNote:When billing the items listed above include the original purchase date of the device, the last replacement date of the item billed and the reason for replacement.
(Medicare National Coverage Determinations Manual)
Medicare National Coverage Determinations Manual  Chapter 1, Part 1 (Sections 10  80.12)  Coverage Determinations   Table of Contents  (Rev. 12112, Issued: 06- 29-23)  Transmittals for Chapter 1, Part 1   Foreword -  Purpose for National Coverage Determinations (NCD) Manual  10 - Anesthesia and Pain Management  10.1 -  Use of Visual Tests Prior to and General Anesthesia During Cataract Surgery  10.2 -  Transcutaneous Electrical Nerve Stimulation (TENS) for Acute Post-Operative Pain  10.3 -  Inpatient Hospital Pain Rehabilitation Programs  10.4 -  Outpatient Hospital Pain Reh abilitation Programs  10.5 -  Autogenous Epidural Blood Graft  10.6 -  Anesthesia in Cardiac Pacemaker Surgery  20 - Cardiovascular System  20.1 -  Vertebral Artery Surgery  20.2 -  Extracranial -  Intracranial (EC -IC) Arterial Byp ass Surgery  20.3 -  Thoracic Duct Drainage (TDD) in Renal Transplants  20.4  Implantable Cardioverter Defibrillators (ICDs)  20.5-  Extracorporeal Immunoadsorption (ECI) Using Protein A Columns   (RETIRED)  20.6 -  Transmyocardial Revascularization (TMR)  20.7 -  Percutaneous Transluminal Angioplasty (PTA)  (Various Effective Dates Below)  20.8 -  Cardiac Pacemakers (Various Effective Dates Below)  20.8.1 -  Cardiac Pacemaker Evaluation Services  20.8.1.1 -  Transtelephonic Monitoring of Cardiac Pacemakers  20.8.2 -  Self-Contained Pacemaker Monitors  20.8.3  Single Chamber and Dual Chamber Permanent Cardiac Pacemakers                         20.8.4 Leadless Pacemakers