evekhm/cms_iom_500 huggingface dataset:
Article - Billing and Coding: MolDX: ApoE Genotype (A55094)
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-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 837PItem 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: ApoE Genotype (A55095)
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-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 837PItem 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: ATP7B Gene Tests (A55097)
CMS National Coverage PolicyN/AArticle TextATP7B 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 CPTcode for the performed service:81406 - ATP7B, fgs81443 - Genetic Testing for severe genetic 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 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 837PItem 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: ATP7B Gene Tests (A55098)
CMS National Coverage PolicyN/AArticle TextATP7B 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 CPTcode for the performed service:81406 - ATP7B, fgs81443 - Genetic Testing for severe genetic 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 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 837PItem19 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: BCKDHB Gene Test (A55099)
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 TextBCKDHB (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 Contractor 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 test.To receive a BCKDHB test service denial, please submit the following claim information:CPT code 81205- BCKDHB, common variantsCPT code 81406- BCKDHM, full gene sequenceCPT code 81443 - Genetic testing for severe inherited conditionsAn Advanced Beneficiary Notice (ABN) is not required for statutorily excluded services.For a voluntary issued ABN, append with GX modifierTo indicate a statutorily excluded service, append with a GY modifierEnter theDEX Z-Codeidentifier adjacent tothe CPT code in thecomment/narrative field for the following Part B claim field/types:Loop 2400 or SV101-7 for the 5010A1 837PItem 19 for paper claimEnter theDEX Z-Codeidentifier adjacent tothe CPT code in thecomment/narrative field for the following PartA claim field/types:Line SV202-7 for the 837PBlock 80 for the UB-04
Article - Billing and Coding: MolDX: BCKDHB Gene Test (A55100)
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 TextBCKDHB (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 Contractor 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 test. To receive a BCKDHB test service denial, please submit the following claim information:CPTcode 81205- BCKDHB, common variantsCPTcode 81406- BCKDHM, full gene sequenceCPTcode 81443 - Genetic testing for severe inherited conditionsAn Advanced 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 theDEX Z-Codeidentifier adjacent tothe CPT code in thecomment/narrative field for the following Part B claim field/types:Loop 2400 or SV101-7 for the 5010A1 837PItem 19 for paper claimEnter theDEX Z-Codeidentifier adjacent tothe CPT code in thecomment/narrative field for the following PartA claim field/types:Line SV202-7 for the 837PBlock 80 for the UB-04
Article - Billing and Coding: MolDX: BLM Gene Analysis (A55113)
CMS National Coverage PolicyN/AArticle TextThe 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 following:CPTcode 81209or CPTcode 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 theDEX 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 837PItem19 for paper claimEnter the 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 the 837IBlock 80 for UB04claim form
Article - Billing and Coding: MolDX: BLM Gene Analysis (A55114)
CMS National Coverage PolicyN/AArticle TextThe 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 following:CPTcode 81209or CPTcode 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 theDEX 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 837PItem 19 for paper claimEnter the 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 the 837IBlock 80 for UB04claim form
Article - Billing and Coding: MolDX: BluePrint® Test (A55115)
CMS National Coverage PolicyN/AArticle TextTo 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:CPTcode 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 modifierEnter the 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 837PItem19 for paper claimEnter DEX Z-Code identifieradjacent to the CPT code in the comment/narrative field for the following Part A claim field/types:Line SV202-7 for the 837I electronic claimBlock 80 for the UB04 claim form.
Article - Billing and Coding: MolDX: BluePrint® Test (A55116)
CMS National Coverage PolicyN/AArticle TextTo 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:CPTcode 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 modifierEnter the 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 837PItem19 for paper claimEnter DEX Z-Code identifieradjacent to the CPT code in the comment/narrative field for the following Part A claim field/types:Line SV202-7 for the 837I electronic claimBlock 80 for the UB04 claim form.
Article - Billing and Coding: Prolonged Drug and Biological Infusions Started Incident To a Physician’s Service Using an External Pump (A55134)
CMS National Coverage PolicyN/AArticle TextUnder section 1861(s)(2)(A) of the Social Security Act (the Act), Medicare will pay for drugs and biologicals which are not usually self-administered by the patient furnished as incident to physicians services rendered to outpatients. In order for Medicare to pay for a drug or biological under section 1861(s)(2)(A) or (B) of the Act, the physician or hospital (respectively) must incur a cost for the drug or biological. Generally, the administration of drugs or biologicals covered by Medicare under the incident to benefit (1861(s)(2)(A) and (B)) will start and end while the patient is in the physicians office or the hospital outpatient department under the supervision of a physician. Medicares payment for the administration of the drug or biological billed to the MAC will also include payment for equipment used in furnishing the service. Equipment, such as an external infusion pump used to begin administration of the drug or biological that the patient takes home to complete the infusion, is not separately billable as durable medical equipment for a drug or biological paid under the section 1861(s)(2)(A) and (B) incident to benefit.There are some situations where a hospital or office may purchase a drug for a medically reasonable and necessary prolonged drug infusion, then begin the drug infusion in the care setting using an external pump, send the patient home for a portion of the infusion duration, and have the patient return at the end of the infusion period. In this case the drug or biological continues to be covered and is billable incident to a physicians service even though the entire administration of the drug or biological did not occur in the physicians office or the hospital outpatient department. For complete information, please see MLN Matters SE1609.Part A: Administration of Non-Chemotherapy Drug Infusions
Article - Billing and Coding: Prolonged Drug and Biological Infusions Started Incident To a Physician’s Service Using an External Pump (A55134)
Part A: Administration of Non-Chemotherapy Drug InfusionsWhen reporting services for prolonged drug infusions using an external pump that were initiated in the hospital or office setting, Part A Providers should continue to report any applicable CPT/HCPCS codes for the drug or biological and its administration, and should report procedure code 96379 for the use of the external pump. The word PUMP should be entered in the REMARKS section of the CMS-1450 (UB-04) claim form or the electronic equivalent to indicate the claim is for use of an external pump for the administration of prolonged drug infusion services. CPT code 96379 may be payable through APC and should be reported on a single line for each date of service.Part B: Administration of Non-Chemotherapy Drug InfusionsWhen reporting services for prolonged drug infusions using an external pump that were initiated in the hospital or office setting, Part B Providers should continue to report any applicable CPT/HCPCS codes for the drug or biological and its administration, and should report procedure code 96379 for the use of the external pump. The word PUMP should be entered in block 19 on the CMS-1500 claim form or the electronic equivalent to indicate the claim is for use of an external pump for the administration of prolonged drug infusion services. CPT code 96379 should be billed on a single line for each date of service.Part A and Part B: Administration of Chemotherapy Drug InfusionsHCPCS code G0498 is to be used when billing prolonged drug and biological infusions for chemotherapy administration started incident to a physicians service using an external pump. It is not necessary to include the word PUMP in block 19 or the equivalent section for electronic claims.Note:HCPCS code G0498 includes the chemotherapy administration, providers should not report HCPCS code G0498 with CPT code 96416 (Initiation of prolonged chemotherapy infusion (more than 8 hours), requiring use of a portable or implantable pump).
( se1609)
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 other interpretive materials for a full and acc urate statement of their contents. CPT only copyright 2015 Amer ican Medical Association.   Page 1 of 3 DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services   MLN Matters Number: SE1609 Related Change Request (CR) #: N/A Related CR Release Date: N/A Effective Date: N/A Related CR Transmittal #: N/A Implementation Date: N/A Medicare Policy Clarified for Pro longed Drug and Biological Infusions Started Incident to a Physician's Service Using an External Pump  Note:  We revised this article on June 6, 2019, to update the web link s. All other information is unchanged. Provider Types Affected This MLN Matters Special Editi on article is intended for all physicians and hospital outpatient departments submitting claims to Medicare Administrative Contractors (MACs) for prolonged dr ug and biological infusions started inci dent to a physician's service using an external pump. Note that this article does not apply to suppliers claims submitted to Durable Medical Equipment MACs ( DME MACs). What You Need to Know Medicare pays for drugs and biol ogicals which are not usually self-administered by the patient and furnished inci dent to physicians services re ndered to patients while in the physicians office  or the hospital outpatient depa rtment.  In some situations, a hospital outpati ent department or physician office may:  Purchase a drug for a medicall y reasonable and necessary prolo nged drug infusion,  Begin the drug infusion in the care setting using an external pump,   Send the patient home for a portion of the infusion, and   Have the patient return at t he end of the infusion period.   MLN Matters Number: SE1609 Relat ed Change Request Number: N/A
( se1609)
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.
( se1609)
Page 2 of 3 In this case, the drug or biologi cal, the administration, and the external infusion pump is billed to your MAC . However,  because prolonged drug and biological infusions started incident to a physician's service using an external pump should be treated as an incident to service, it cannot be billed on suppliers claims t o DME MACs.  Background Under section 1861(s)(2)(A) of the S ocial Security Act (the Act ), Medicare will pay for drugs and biologicals which are f urnished incident to a physi cians professi onal service.  Under section 1861(s)(2)(B) of the  Act, Medicare will pay for d rugs and biologicals which are not usually self-administer ed by the patient furnished as incident to physicians services rendered to outpatients.  In order for Medicare to pay  for a drug or biological under section 1861(s)(2)(A) or (B) of t he Act, the physician or hospi tal (respectively) must incur a cost for the drug or biological.  G enerally, the a dministration  of drugs or biologicals covered by Medicare under the inc ident to benefit (1861(s)(2)(A) and (B)) will start and end while the patient is in the physicians office or the hospi tal outpatient department under the supervision of a physician. However, in some situations a hospital or office may purchase a  drug for a medically reasonable and necessary prolonged drug infusion, then begin th e drug infusion in the care setting using an external pump, send the patient home for a portion of the infusion duration, and have the patient return at th e end of the infusion period.  In this case, the drug or biological continues to be cove red under secti on 1861(s)(2)(A) and (B) of the Act and is billable to the MAC even though the entire administration of th e drug or biological did not occur in the physicians offi ce or the hospital outpatient 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