evekhm/cms_iom_500 huggingface dataset:
Article - Billing and Coding: MolDX: SULT4A1 Genetic Testing (A54283)
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 TextSulfotransferase 4A1 (SULT4A1) is an enzyme found in the brain that interacts with numerous neuroactive molecules, including some catecholamines and neural steroids. Findings suggest the SULT4A1-1 haplotype of SULT4A1 is associated with enhanced response to antipsychotic drug therapy. At present there is insufficient evidence to support SULT4A1 genotyping to determine medical management. Therefore, the MolDX Team has determined SULT4A1 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 the SULT4A1 gene as a statutorily excluded service.To receive a SULT4A1 test 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 HCPCS modifierTo indicate a statutorily excluded service, append with a GY HCPCS 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: STAT3 Gene Testing (A54284)
CMS National Coverage PolicyN/AArticle TextEffective for dates of service on and after June 26, 2013STAT3 gene testing may be performed during the diagnosis of Autosomal Dominant Hyper IgE Syndrome (AD-HIES). Since management is not determined by the presence or absence of a STAT3 mutation in patients with a probably clinical diagnosis, CGS Administrators and the MolDX program contractor has determined STAT3 analysis is a statutorily excluded test.To receive a STAT3 analysis service denial, please submit the following claim information:CPT code 81405  STAT3, targeted sequence analysisAn 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 modifierSelect the appropriate diagnosis for the patientEnter the appropriate DEX Z-code identifier adjacent to the CPT code in the comment/narrative field for the following claim field/types:Loop 2300 NTE01/SV202-7 for Part A or Loop 2400 NTE02/ SV101-7 for Part BForm locator 80 for Part A or Box 19 for Part B on paper claim
Article - Billing and Coding: MolDX: SMPD1 Genetic Testing (A54285)
CMS National Coverage PolicyN/AArticle TextEffective for dates of service on and after February 7, 2013.Mutations found in sphingomyelin phosphodiesterase 1, (SMPD1) acid lysomal, are associated with Niemann-Pick Disease, characterized by acid sphingomyelinase (ASM) deficiency. For infants and children, SMPD1 genetic testing is used to confirm the clinical findings from blood tests to diagnose ASM. Genetic testing for adults is used to screen the population for potential carriers of the mutation. Therefore, the MolDX team has determined that SMPD1 genetic testing is not a Medicare benefit and is a statutorily excluded service. In addition to single disease testing, MolDX will also deny panels of tests that include a SMPD1 gene test as a statutorily excluded service.To receive a SMPD1 test denial, please submit the following claim information:CPTcode 81330- SMPD1, common variantsCPTcode 81412  Ashkenazi Jewish Associated DisordersFor a voluntary issued ABN, append with GX modifierTo indicate a statutorily excluded service, append with a GY modifier. An Advance Beneficiary Notice (ABN) is not required for statutorily excluded services
Article - Billing and Coding: MolDX: Mitochondrial Nuclear Gene Tests Guidelines (A54288)
CMS National Coverage PolicyN/AArticle 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: myPap™ (A54290)
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 myPAP DNA test, developed to complement a Papanicolaou (Pap) test, confirms a Pap specimen belongs to the patient evaluated for treatment. The MolDX Team agrees the healthcare community should define and follow strict procedures regarding patient and patient specimen identification and handling. Tests performed to measure the quality or control of a process and do not provide information to diagnose or treat a patient illness or injury do not meet the criteria for a Medicare benefit. Therefore, the myPAP test is a statutorily excluded test. Although an Advance Beneficiary Notice (ABN) is not required for a statutory exclusion, providers supplying this test (directly or through a purchased service) should ensure patients understand the test is not a covered benefit.Providers must register for a DEX Z-Code identifier prior to claim submission. To access the MolDX registry, go to the DEX Diagnostics Exchange located at: https://app.dexzcodes.com/login. Once an ID has been obtained, please submit the following claim information to receive a myPap Medicare service denial:CPTcode 84999  unlisted chemistry procedureAn Advance Beneficiary Notice (ABN) is not required for statutorily excluded serviceFor 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 formIf you believe your practice has submitted claims and received reimbursement in error, you may take the following corrective actions:
Article - Billing and Coding: MolDX: myPap™ (A54290)
If you believe your practice has submitted claims and received reimbursement in error, you may take the following corrective actions:Complete a Self-AuditIdentify incorrect submissionsContain further claim submission errorsConsider Self-Disclosure ProtocolSelf-disclosure guidelines
Article - Billing and Coding: MolDX: NSD1 Gene Tests (A54291)
CMS National Coverage PolicyN/AArticle TextEffective for dates of service on and after June 26, 2013.NSD1 gene testing may be performed during the diagnosis of Sotos Syndrome. Since testing is limited to reproductive risk assessment, the MolDX Team has determined NSD1 gene testing is a statutorily excluded service. MolDX will also deny tests that include one or more of NSD1 analysis reported with CPTcode 81479 as statutorily excluded tests.To receive a NSD1 analysis service denial, please submit the following claim information:Select appropriate CPTcode according to genetic material testsCode 81405 for NSD1 duplication/deletionCode 81406 for NSD1 gene sequencingCode 81479 for combinations of NSD1 analysisAn 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 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: PAX6 Gene Sequencing Guidelines (A54293)
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: PIK3CA Gene Tests (A54295)
CMS National Coverage PolicyN/AArticle TextEffective for dates of service on and after May 24, 2019.The U.S. Food and Drug Administration (FDA) has approved Piqray (alpelisib) tablets, to be used in combination with the (FDA)-approved endocrine therapy fulvestrant, to treat postmenopausal women, and men, with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA-mutated, advanced or metastatic breast cancer (as detected by an FDA-approved test) following progression on or after an endocrine-based regimen.To submit a claim for PIK3CA targeted gene sequencing service, please submit the following claim information:Enter the appropriate CPTcodeSelect the appropriate diagnosis for the patientEnter 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: PTCH1 Gene Testing (A54297)
CMS National Coverage PolicyN/AArticle TextEffective for dates of service on and after June 26, 2013PTCH1 gene testing may be performed during the diagnosis of Nevoid Basal Cell Carcinoma Syndrome (NBCCS). Since the diagnosis of NBCCS is established using clinical diagnostic criteria and carrier testing is not a covered benefit, CGS Administrators, LLC have determined PTCH1 analysis is a statutorily excluded test.To receive a PTCH1 analysis service denial, please submit the following claim information:CPT code 81479An 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 modifierSelect the appropriate diagnosis for the patientEnter 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: RPS19 Gene Tests (A54299)
CMS National Coverage PolicyN/AArticle TextEffective for dates of service on and after June 25, 2013.RPS19 gene sequencing, deletion/duplication and known familial mutation analysis may be performed during the diagnosis of Diamond-Blackfan Anemia (DBA). Since clinical symptoms and diagnosis usually occur prior to Medicare eligibility and carrier testing is not a covered benefit, the MolDX Team has determined RPS19 analysis is a statutorily excluded test. MolDX will also deny tests that include one or more of RPS19 analysis reported with CPT code 81479 as statutorily excluded services.To receive a RPS19 analysis service denial, please submit the following claim information:Select appropriate CPT code according to genetic material testedCode 81405 for gene sequencingCode 81479 for combinations of RPS19 analysisAn 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 modifierSelect the appropriate diagnosis for the patientEnter 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: SEPT9 Gene Test (A54300)
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) (eg, 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-CodeIdentifier adjacent to the CPT code in the comment/narrative field for the following claim field/types:Loop 2300 NTE01/SV202-7 for Part A or Loop 2400 NTE02/ SV101-7 for Part BForm locator 80 for Part A or Box 19 for Part B on paper claim
Article - Billing and Coding: ArgusM II Retinal Prosthesis System (A54327)
CMS National Coverage PolicyN/AArticle TextThe ArgusM II Retinal Prosthesis System (CPT Code 0100T) has been approved by the FDA for marketing under the humanitarian device exemption (HDE) application. This device is indicated for use in patients with severe to profound retinitis pigmentosa who are -Adults, age 25 years or older.Bare light or no light perception in both eyes. (If the patient has no residual light perception, then evidence of intact inner layer retina function must be confirmed.)Previous history of useful form vision.Aphakic or pseudophakic. (If the patient is phakic prior to implant, the natural lens will be removed during the implant procedure.)Patients who are willing and able to receive the recommended post-implant clinical follow-up, device fitting, and visual rehabilitation.In addition, the Argus II implant is intended to be implanted in a single eye, typically the worse seeing eye.The office outpatient AND hospital in-patient medical records must clearly reveal how all of the above indications were met.The ArgusM II Retinal Prosthesis CPT Code is effective for dates of service on or after February 20, 2014.When submitting a claim for 0100T the ICD-10 code H35.52 should be submitted on the claim.For replacement parts bill L8608 and include name of part being replaced and invoice information.
Article - Billing and Coding: MolDX: Germline testing for use of PARP inhibitors (A54338)
CMS National Coverage PolicyTitle XVIII of the Social Security Act (SSA) 1833(e) prohibits Medicare payment for any claim lacking the necessary documentation to process the claim.Article TextThe United States (U.S.) Food and Drug Administration (FDA) has approved several poly ADP-ribose polymerase (PARP) inhibitor treatments indicated for patients with ovarian cancer, breast cancer, pancreatic cancer, and prostate cancer.Results of tests that assess for deleterious variants in homologous recombination repair (HRR) genes such as BRCA1 and 2 can be used as an aid in patients who are being considered for treatment with PARP inhibitors in accordance with published guidelines and approved therapeutic product labeling. These genes are often tested as part of routine management of these cancer patients as part of services that interrogate a panel of genes as described in LCD L38966. In rare circumstances limited testing for only a select group of genes may be tested to ensure compliance with FDA indicated drug usage, wherein additional genes outlined in guidelines such as the NCCN are not necessary because the patient does not meet testing criteria for larger panels.According to criteria defined by L38966, billing for these services can occur in the following situation:The patient meets clinical indication for immediate use of a PARP inhibitor for an FDA-approved use ANDThe patient has had no previous germline testing for hereditary cancer or somatic testing of the same cancer that included the genes necessary for testing ANDThe patient does not meet germline testing requirements per existing guidelines or standards of care outlined in policy L38966 requiring more comprehensive testing.To report a service, please submit the following claim information:Select appropriate CPTcodeOne (1) unit of serviceEnter 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 837PItem19 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 formSelect at least one ICD-10-CM diagnosis code.
Article - Billing and Coding: MolDX: Afirma™ Assay by Veracyte (A54356)
CMS National Coverage PolicyN/AArticle TextThe following coding and billing guidance is to be used with its associated Local coverage determination.The MolDXTeam 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,MolDX 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 aspirationMolDXexpects 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, submit the following claim information:Select the appropriate CPT codeSelect the appropriate ICD-10-CM diagnosisEnter the DEX Z-Code identifier in the comment/narrative field for the following Part B claim field/types:Loop 2400 or SV101-7 for the 5010A1 837PItem19 for paper claimEnter the DEX Z-Code identifier in the comment/narrative field for the following PartA claim field/types:Line SV202-7 for 837I electronic claimBlock 80 for the UB04 claim form
Article - Billing and Coding: MolDX: Afirma™ Assay by Veracyte (A54358)
CMS National Coverage PolicyN/AArticle TextThe following coding and billing guidance is to be used with its associated Local coverage determination.The MolDXTeam 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,MolDX 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 aspirationMolDXexpects 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, submit the following claim information:Select the appropriate CPT code.Select the appropriate ICD-10-CM diagnosisEnter the DEX Z-Code identifier in the comment/narrative field for the following Part B claim field/types:Loop 2400 or SV101-7 for the 5010A1 837PItem19 for paper claimEnter the DEX Z-Code identifier in the comment/narrative field for the following PartA claim field/types:Line SV202-7 for 837I electronic claimBlock 80 for the UB04 claim form