evekhm/cms_iom_500 huggingface dataset:
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depa rtment.  Also, the drug or biological continues to meet the r equirements for the incident to benefit as the physician or hospital incurred a cost for the drug or biological and the administration of the drug began in a physicians office or hospital incident to a physicians service.  For the administration of the drug, the phys ician supervision rules und er 42 CFR 410.26(b)(5) and 42 CFR 410.27 (a)(1)(iv) and CMS Publication 100-02, chapter 15 , section 50.3 apply only while the patient is present in the physicians office or hospital outpatient department.  CMS does not provide specific coding guidance; however, appropriate drug administration codes for this situation would desc ribe the services that are provided by the physician or hospital (for example, intravenous infusion, patient monitoring ) while the patient is in the office or the outpatient setting. Medicares payment for the administration of the drug or biolog ical billed to the MAC will also include payment for equipm ent used in furnishing the service.  Equipment, such as an external infusion pump used to be gin administration of the drug or biological that the patient takes home to complete th e infusion, is not separately billable as durable medical equipment for a drug or biol ogical paid under th e section 1861( s)(2)(A) and (B) incident to benefit.  The MAC may direct  use of a code described by CPT or an otherwise applicable HCPCS code for the drug adminis tration service.  If necessary, the MAC may direct use of a miscellaneous code for the drug a dministration if there is no  specified code that describes MLN Matters Number: SE1609 Relat ed Change Request Number: N/A
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Page 3 of 3 the drug administration service that also accounts for the cost  of equipment that the patient takes home to complete the infu sion that they later return to the physician or hospital. Additional Information If you have questions, your MACs may have more information. Fin d their website at http://go.cms.gov/MAC-website-list . DOCUMENT HISTORY  Date of Change Description June 6, 2019 We revised this article to update the web links. A ll other information is unchanged. April 4, 2016 Initial article released.   Disclaimer This article was prepared as a service to the public and is not  intended to grant rights or impose obligations. This article m ay contain references or links to statutes, regulations, or other policy materials. The information provided is only intended to be a general summary. It is not intended to take the place of either the written law or regulations. We encourage readers to review the specific statutes, regulations and othe r interpretive materials for a full and accurate statement of their contents. CPT only copyr ight 2015 American Medical Association.
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Copyright  2018, the American Hospital Association, Chicago, I llinois. Reproduced with permission. No portion of the AHA copyrighted materials contained within this publication may be copied without the express written consent of the AHA. AHA copyrighted materia ls including the UB-04 codes and descriptions may not be removed , copied, or utilized within any software, product, service, solution or derivative work with out the written consent of the AHA. If an entity wishes to utilize any AHA materials, please contact the AHA at 312- 893-6816. Making copies or utiliz ing the content of the UB-04 Manual, including the codes a nd/or descriptions, for internal purposes,  resale and/or to be used in any product or publication; c reating any modified or deriv ative work of the UB-04 Manual and/or codes and descriptions; and/or making any commercial use of UB-04 Manual or any portion thereof, including the codes and/or descriptions, is only authorized with an express l icense from the American Hospital Association. To license the electronic data file of UB-04 Data Specifications, contact Tim Carlson at (312) 893-6816 or Laryssa Marshall at (312) 893-6814. You may a lso contact us at ub04@healthforum.com    The American Hospital Associatio n (the AHA) has not reviewed, and is not responsible for, the completeness or accuracy of any information contained in this m aterial, nor was the AHA or any of its affiliates, involved in the pre paration of this material, or th e analysis of information provided in the material. The views and/or posit ions presented in the material do not necessarily represent the views of the AHA. CMS and its products  and services are not endorsed by the AHA or any of its affiliates.
Article - Billing and Coding: Lab: Immunohistochemistry (IHC) Indications for Breast Pathology (A55136)
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:CPT CodeSpecimenUnit of service (UOS)88342First single/multiplex stain188341Each additional2To report morphometric analysis,select oneof the following codes based on the type of morphometric analysis:CPT CodeService typeUOS88360Manual388361Computer-assisted3Note: a unit of service applies to a single separately identifiable specimen.
Article - Billing and Coding: MolDX 4q25-AF Risk Genotype Testing (A55137)
CMS National Coverage PolicyN/AArticle TextEffective for dates of services on and after 06/14/2012.The 4q25-AF Risk Genotype Test was developed to help predict the risk of atrial fibrillation and cardioembolic stroke. To date, there is insufficient evidence to support the required clinical utility for the established Medicare benefit category.As reviewed, the developer described the indication to perform a 4q25-AF Risk 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, the 4q25-AF Risk Genotype Test would continue to be a statutory excluded service.To receive a 4q25-AF Risk genotype service denial, please submit the following claim information:CPT code 81479  Unlisted molecular pathology procedureAn 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 modifierLabs 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 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 CPT code in the comment/narrative field for the following Part A claim field/type:Line SV202-7 for 837I electronic claimBlock 80 for the UB04 claim form
Article - Billing and Coding: MolDX: 9p21 Genotype Test (A55138)
CMS National Coverage PolicyTitle XVIII of the Social Security Act, Sec. 1862 (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:CPT code 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 modifierLabs 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 the following PartB claim field/types:Loop 2400 or SV101-7 for the 5010A1 837PBox 19 for paper claimEnterthe appropriate DEX Z-Code identifier adjacent to the CPT code 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 Update (A55139)
CMS National Coverage PolicyN/AArticle TextThe MolDX Team 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):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 adenopathyHave 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 CPT CodeLabs 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 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 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 diagnosis.
Article - Billing and Coding: MolDX: ApoE Genotype (A55141)
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:CPT code 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 modifierLabs 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 CPT code in the comment/narrative 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 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: Aspartoacyclase 2 Deficiency (ASPA) Testing (A55142)
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 2/7/2013.Asparoacyclase 2 Deficiency (ASPA) Testing, also known as Canavan Disease, is an autosomal recessive degenerative disorder that causes progressive nerve damage to nerve cells in the brain. Genetic testing identifies parents that may be at risk for conceiving a child with the disease and offspring suspected to have or diagnosed with the disease. Therefore, the MolDX Team has determined that testing for the ASPA is not a Medicare benefit and is a statutorily excluded test. MolDX will also deny panels that include ASPA testing.To receive an ASPA service denial, please submit the following claim information:Select one of the following CPT codes for the performed service:81200 - ASPA, common variant81412 - Ashkenazi Jewish associated disorders81443 - Genetic testing for severe inherited conditions81479 - Unlisted molecular pathology proceduresAn 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 modifierLabs 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 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 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: ATP7B Gene Tests (A55143)
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 July 24, 2013.ATP7B gene mutations have been primarily associated with Wilson Disease, a disorder of copper metabolism. However, serology remains the gold standard for testing and treating the signs and symptoms of this condition. At present the literature does not support that ATP7B gene testing changes physician treatment or improves patient outcomes. Therefore, the MolDX Team has determined ATP7B gene testing is a statutorily excluded service. MolDX will also deny panels of tests that include the ATP7B gene.To receive an ATP7B gene test denial, please submit the following claim information:Select the appropriate CPT code for the performed service:81406 - ATP7B, fgs81443-Genetic testing for severe inherited conditions81479 - Unlisted molecular pathology procedureAn 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 modifierLabs 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 Z-Code identifier adjacent tothe 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 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 form
Article - Billing and Coding: MolDX: BCKDHB Gene Test (A55145)
CMS National Coverage PolicySec. 1862 (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 February 7, 2013.BCKDHB (branched-chain keto acid dehydrogenase E1, beta polypeptide) gene testing identifies mutations in the BCKDHA, BCKDHB, DBT, and DLD genes causing maple syrup urine disease (MSUD). Genetic testing identifies parents at risk for conceiving a child with MSUD. Therefore, the MolDX Team has determined that BCKDHB gene testing to identify parents at risk is not a Medicare benefit and a statutorily excluded test. In addition to single disease testing, MolDX will also deny panels of tests that include the BCKDHB gene as a statutorily excluded testTo receive a BCKDHB test service denial, please submit the following claim information:CPT code 81205-common variantsCPT code 81406-BCKDM, full gene sequenceCPT code 81443-Genetic testing for severe inherited conditionsAn 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 modifierLabs 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 each code in the stack 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 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: BluePrint® Test (A55146)
CMS National Coverage PolicyN/AArticle TextThe MolDX team has completed a technical assessment on BluePrint, a molecular subtyping assay. To date, there is insufficient evidence to support the required clinical utility for the established Medicare benefit category. Therefore, the BluePrint test is a statutorily excluded test.To receive a BluePrint service denial, please submit the following claim information:CPT code 81479- Unlisted molecular pathology procedureAn 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 modifierLabs may either use the SV101-7 or SV202-7 (preferred) or the NTE field to submit this required information.Enter appropriate DEX Z-Code identifieradjacent to the CPT code in the comment/narrative field for the following Part Bclaim field/types:Loop 2400 or SV101-7 for the 5010A1 837PBox 19 for paper claim. (Note: Only one test/identifier per paper claim may be submitted.)Enter 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 form
Article - Billing and Coding: MolDX: bioTheranostics Cancer TYPE ID® Update (A55147)
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 new identifier to reflect the changes in the test.To bill for Cancer TYPE ID services, 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 fieldLabs may either use the SV101-7 or SV202-7 (preferred) or the NTE field to submit this required informationEnter the appropriate DEX Z-CodeIdentifier 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 the appropriate DEX Z-Codeidentifier 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.Note: MolDX expects this test to ONLY beorderedby the treating physician.
Article - Billing and Coding: MolDX: BLM Gene Analysis (A55148)
CMS National Coverage PolicyN/AArticle TextEffective for dates of service on and after July 30, 2014.The clinical diagnosis of Bloom (BLM syndrome, BSyn), characterized by severe pre and postnatal growth deficiency, highly characteristic sparseness of subcutaneous fat tissue in infants and children, is confirmed through cytogenetic testing. Molecular genetic testing identifies BLM gene mutation carriers at risk for conceiving offspring with the disease. Therefore, BLM 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 BLM gene as a statutorily excluded service.To receive a BLM gene test service denial, please submit the followingCPT code 81209 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 modifierLabs may either use the SV101-7 or SV202-7 (preferred) or the NTE field to submit this required informationEnter the appropriate 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 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 form