evekhm/cms_iom_3000 huggingface dataset:
Article - Billing and Coding: MolDx: ResponseDX Tissue of Origin® (A54494)

CMS National Coverage PolicyN/AArticle TextTissue of Origin, a microarray-based gene expression assay designed to determine the similarity of unknown or unresolved tumors to cancers from 1 of 15 known tumors of origin, has been assigned a unique identifier.To bill for Tissue of Origin services, please provide the following claim information:CPTcode 81504 - Oncology (tissue of origin)Enter 1 in the Days/Unit fieldSelect the appropriate ICD-10-CM diagnosis.Enter DEX Z-Code identifier adjacent to the 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 formNote:Noridian expects this test to ONLY be ordered by the treating physician.
Article - Billing and Coding: MolDx: ResponseDX Tissue of Origin® (A54496)

CMS National Coverage PolicyN/AArticle TextTissue of Origin, a microarray-based gene expression assay designed to determine the similarity of unknown or unresolved tumors to cancers from 1 of 15 known tumors of origin, has been assigned a unique identifier.To bill for Tissue of Origin services, please provide the following claim information:CPT code 81504 - Oncology (tissue of origin)Enter 1 in the Days/Unit fieldSelect the appropriate ICD-10-CM diagnosis.Enter DEX Z-Code identifier adjacent to the 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 formNote:Noridian expects this test to ONLY be ordered by the treating physician.
Article - Billing and Coding: MolDX: FDA-Approved KRAS Tests (A54498)

CMS National Coverage PolicyTitle XVIII of the Social Security Act, 1833(e) prohibits Medicare payment for any claim which lacks the necessary information to process the claim.Article TextThe following coding and billing guidance is to be used with its associated Local coverage determination.Two tests have met the Food and Drug Administration (FDA) criteria for KRAS genetic testing:1. Effective 7/06/2012therascreen KRAS to detect 7 somatic mutations in the human KRAS oncogene was developed to aid in the identification of colorectal cancer (CRC) patients for treatment with Erbitux (cetuximab).2. Effective 5/7/2015cobas KRAS to detect mutations in codons 12 and 13 of the KRAS gene was developed to aid in identification of CRC patients for treatment with Erbitux (cetuximab) or Vectibix (panitumumab).To report an FDA approved or laboratory developed test (LDT) KRAS, service, please submit the following claim information.Select the appropriate CPT codeEnter 1 unit of Service (UOS)Enter the appropriate DEXZ-Code Identifier 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 appropriate DEXZ-Code Identifier in the comment/narrative field for the following PartA claim field/types:Line SV202-7 for the 837I electronic claimBlock 80 for the UB04 claim formSelect the appropriate ICD-10-CM diagnosis.NOTE:MolDX will apply National Provider Identifier (NPI) to ID editing on FDA approved KRAS kits. All labs that submit claims for a KRAS, codon 12 and 13 test kitMUSTregister the test and confirm theUNMODIFIEDuse of the kit. Tests may be registered on theDEX Diagnostics Exchange:https://app.dexzcodes.com/login.This article reflects the FDA-approved indications on article creation date. MolDX will allow future FDA approved and amended indications for these tests.
Article - Billing and Coding: MolDX: FDA-Approved KRAS Tests (A54500)

CMS National Coverage PolicyTitle XVIII of the Social Security Act, 1833(e) prohibits Medicare payment for any claim which lacks the necessary information to process the claim.Article TextThe following coding and billing guidance is to be used with its associated Local coverage determination.Two tests have met the Food and Drug Administration (FDA) criteria for KRAS genetic testing:Effective 7/6/2012therascreen KRAS to detect 7 somatic mutations in the human KRAS oncogene was developed to aid in the identification of colorectal cancer (CRC) patients for treatment with Erbitux (cetuximab).2. Effective 5/7/2015cobas KRAS to detect mutations in codons 12 and 13 of the KRAS gene was developed to aid in identification of CRC patients for treatment with Erbitux (cetuximab) or Vectibix (panitumumab).To report an FDA approved or laboratory developed test (LDT) KRAS, service, please submit the following claim information.Select the appropriate CPT codeEnter 1 unit of service (UOS)Enter the appropriate DEXZ-Code Identifier 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 appropriate DEXZ-Code Identifier in the comment/narrative field for the following PartA claim field/types:Line SV202-7 for the 837I electronic claimBlock 80 for the UB04 claim formSelect the appropriate ICD-10-CM diagnosis.NOTE:MolDX will apply National Provider Identifier (NPI) to ID editing on FDA approved KRAS kits. All labs that submit claims for a KRAS, codon 12 and 13 test kitMUSTregister the test and confirm theUNMODIFIEDuse of the kit. Tests may be registered on theDEX Diagnostics Exchange:https://app.dexzcodes.com/login.This article reflects the FDA-approved indications on article creation date. MolDX will allow future FDA approved and amended indications for these tests.
Article - Therapeutic Apheresis for Familial Hypercholesterolemia (A54543)

CMS National Coverage PolicyN/AArticle TextNational Coverage Determination (NCD) for Apheresis Therapeutic Pheresis (110.14) allows Medicare Administrative Contractor coverage discretion in the use of therapeutic apheresis in the treatment of refractory familial hypercholesterolemia.Note: CMS Medicare Learning Network (MLN) (MM) 4250 does not apply to or restrict this use.Noridian covers plasma apheresis for the treatment of familial hypercholesterolemia that is resistant to appropriate lifestyle changes combined with maximal use of statin agents with or without the use of ezetimibe in:1.Functional homozygotes with an LDL cholesterol greater than 500mg/dl;2.Functional heterozygotes with no known cardiovascular disease but a LDL cholesterol greater than 300mg/dl;3.Functional heterozygotes with known cardiovascular disease and a LDL cholesterol greater than 200mg/dl;4.Familial hypercholesterolemia in pregnancy when the physician feels usual therapy is inadequate to assure uteroplacental perfusion.All such claims are subject to either pre- or post-pay review by Noridian or any of the authorized Medicare auditors. The need for this procedure must be clearly documented in the medical records for each visit including which pharmacologic agents are/have been used and what lifestyle changes have been made and, if a beneficiary was intolerant of statins, the actual findings and symptoms reported. Be sure that the clinical notes are properly signed by the treating provider and dated for the date of service.
Article - Therapeutic Apheresis for Familial Hypercholesterolemia (A54545)

CMS National Coverage PolicyN/AArticle TextNational Coverage Determination (NCD) for Apheresis Therapeutic Pheresis (110.14) allows Medicare Administrative Contractor coverage discretion in the use of therapeutic apheresis in the treatment of refractory familial hypercholesterolemia.Note: CMS Medicare Learning Network (MLN) (MM) 4250 does not apply to or restrict this use.Noridian covers plasma apheresis for the treatment of familial hypercholesterolemia that is resistant to appropriate lifestyle changes combined with maximal use of statin agents with or without the use of ezetimibe in:1. Functional homozygotes with an LDL cholesterol greater than 500mg/dl;2. Functional heterozygotes with no known cardiovascular disease but a LDL cholesterol greater than 300mg/dl;3. Functional heterozygotes with known cardiovascular disease and a LDL cholesterol greater than 200mg/dl;4. Familial hypercholesterolemia in pregnancy when the physician feels usual therapy is inadequate to assure uteroplacental perfusion.All such claims are subject to either pre- or post-pay review by Noridian or any of the authorized Medicare auditors. The need for this procedure must be clearly documented in the medical records for each visit including which pharmacologic agents are/have been used and what lifestyle changes have been made and, if a beneficiary was intolerant of statins, the actual findings and symptoms reported. Be sure that the clinical notes are properly signed by the treating provider and dated for the date of service.
Article - Billing and Coding: Eculizumab (A54548)

CMS National Coverage PolicyN/AArticle TextThis article contains billing and coding guidelines that complement the Local Coverage Determination (LCD) Drugs and Biologicals, Coverage of, for Label and Off-Label Uses.Utilization Guidelines:Dose and frequency should be in accordance with the FDA label or recognized compendia (for off-label uses). When services are performed in excess of established parameters, they may be subject to review for medical necessity.Documentation Requirements:Clinical records should document either immunization with a meningococcal vaccine at least 2 weeks prior to administration of the first dose of eculizumab or that the risks of delaying eculizumab outweighed the risk of meningococcal infection.When used for the treatment of an individual with PNH, the following should be documented at initiation of therapy:Flow cytometry confirming the diagnosis of PNH and either of the following (a or b)Evidence of clinically significant hemolysis; orDocumented history of a major adverse vascular event (MAVE) from thromboembolism.Note: for individuals with confirmed PNH who do not meet the documentation requirements above and who were started on a course of eculizumab prior to the effective date of this document, continuation of therapy may be allowed based on the potential risk of adverse events which may occur upon discontinuation or interruption of therapy.When given as an initial trial (generally 6-12 weeks) for the treatment of aHUS, the individual was assessed and both:Had no signs of Shiga toxin E. coli related hemolytic uremic syndrome (STEC-HUS); andThrombotic thrombocytopenic purpura (TTP) was ruled out (for example, normal ADAMTS 13 activity and no evidence of an ADAMTS 13 inhibitor), or if TTP could not be ruled out by laboratory and clinical evaluation, a trial of plasma exchange did not result in clinical improvementWhen eculizumab is continued following an initial trial for aHUS, the records should reflect that there had been clinical improvement (for example, increased platelet count or laboratory evidence of reduced hemolysis).When eculizumab is given for biopsy proven dense deposit disease, elevated serum levels of sC5b-9 (serum Membrane Attack Complex (sMAC) must be documented.FDA and Compendia Review:Clinical Pharmacology website http://www.clinicalpharmacology.com/. Accessed 09/08/2022.FDA label for Soliris (eculizumab). FDA website http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.DrugDetailsLexi-Drugs Web site. http://online.lexi.com. Accessed 09/08/2022.Micromedex DrugDex. http://www.thomsonhc.com/home/dispatch. Accessed 09/08/2022.National Comprehensive Cancer Network website http://www.nccn.org/index.asp. Accessed 09/08/2022.
Article - Billing and Coding: Low frequency, non-contact, non-thermal ultrasound (A54555)

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.Title 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 member.Article TextLow frequency, non-contact, non-thermal ultrasound (CPTcode 97610) describes a system employed in wound care that uses continuous low frequency ultrasonic energy to atomize a liquid and deliver continuous low frequency ultrasound to the wound bed. MIST therapy or other similar products are included in the payment for the treatment of the same wound with other active wound care management or wound debridement CPTcodes (97597, 97598, 97602, 97605, 97606).
Article - Billing and Coding: Xofigo Billing Instructions (A54559)

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 claimArticle TextOn May15, 2013, the U. S. Food and Drug Administration (FDA)approved radium Ra 223 dichloride (XofigoInjection, Bayer HealthCare Pharmaceuticals Inc.) for the treatment of patients with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastatic disease. Xofigois an alpha-particle emitting radiotherapeutic drug which mimics calcium and forms complexes with hydroxyapatite at areas of increased bone turnover, such as bone metastases.Therecommendeddoseand scheduleforXofigois 55 kBq/kg (1.49 microcuries/kg)administered by slow intravenous injection over 1 minute every 4 weeks for 6 doses.Submit:HCPCS code A9606Diagnoses: ICD-10 code C61 - Malignant neoplasm of prostate and C79.51 - Secondary malignant neoplasm of boneORC79.52 - Secondary malignant neoplasm of bone marrowNarrative field or electronic equivalent state "visceral metastases are absent".
Article - Surgical Dressings - Policy Article (A54563)

September 1 Dressing Shipment: Beneficiary has two wounds that require two different categories of dressings, A61XX (max allowance of 30 per month) and A62XX (max allowance of 12 per month)Supplier should bill:A61XX A1 UOS = 30A62XX A1 UOS = 12September 15 Dressing Shipment: Beneficiary has a new wound that requires one of the same categories of dressings as another wound (A61XX  max allowance of 30 per month)Supplier should supply and bill 15 units (to last for the next 2 weeks) and should append the A2 modifier because this dressing category is now used on 2 wounds. NOTE: The modifier number corresponds to the number of wounds on which the dressing is being used, not the total number of wounds treated.A61XX A2 UOS = 15October 1 Dressing Shipment: Beneficiary still has three wounds: two require A61XX (max allowance of 60 per month) and one requires A62XX (max allowance of 12 per month)Supplier should bill:A61XX A2 UOS = 60A62XX A1 UOS = 12If the dressing is not being used as a primary or secondary dressing on a surgical or debrided wound, do not use modifiers A1-A9. When dressings are provided in noncovered situations (e.g., use of gauze in the cleansing of a wound or intact skin), a GY modifier must be added to the code and a brief description of the reason for non-coverage included - e.g., "A6216GY - used for wound cleansing."When tape codes A4450 and A4452 are used with surgical dressings, they must be billed with the AW modifier (in addition to the appropriate A1-A9 modifier). When gradient compression stocking codes A6531 and A6532 or the gradient compression wrap code A6545 are used for an open venous stasis ulcer, the code must be billed with the AW modifier (but not an A1-A9 modifier). For this policy, codes A4450, A4452, A6531, A6532, and A6545 are the only codes for which the AW modifier may be used.The RT and/or LT modifiers must be used with codes A6531, A6532, and A6545 for gradient compression stockings and wraps. Effective for claims with dates of service (DOS) on or after 3/1/2019, when the same code for bilateral items (left and right) is billed on the same date of service, bill each item on two separate claim lines using the RT and LT modifiers and 1 unit of service (UOS) on each claim line. Do not use the RTLT modifier on the same claim line and billed with 2 UOS. Claims billed without modifiers RT and/or LT, or with RTLT on the same claim line and 2 UOS, will be rejected as incorrect coding.When dressing codes are billed for items covered under another benefit (e.g., gauze for a continent ostomy which is covered under the prosthetic device benefit) claims must be billed according to the documentation requirements specified in the applicable policy (see Ostomy Supplies policy for details).Suppliers should contact the PDAC contractor for guidance on the correct coding of these items.
Article - Response to Comments for MolDX: Breast Cancer Assay: Prosigna (A54611)

CMS National Coverage PolicyN/AArticle TextResponse to Comments  DL36125  Breast Cancer Assay: ProsignaComment:Multiple commenters supported the coverage of Prosigna, an FDA approved molecular assay which can be provided in local qualified laboratories.Response:CGS and the MolDx contractor acknowledges the letters of support for coverage for this policy.Comment:A commenter asked to include Bill Types for independent laboratories.Response:Per CMS Internet-Only Manual, Pub 100-08, Medicare Program Integrity Manual, Chapter 13, 13.1.3 LCDs consist of only reasonable and necessary information. All bill type and revenue codes have been removed.
Article - Billing and Coding: Intravenous Immune Globulin (IVIg)-NCD 250.3 (A54641)

CMS National Coverage PolicyCMS National Coverage Determination Manual, 250.3Article TextThis article describes CMS national coverage effective on/after October 1, 2001. Please see the Noridian Local Coverage Determination for additional indications.Patient must meet at least one of the following criteria: Failed conventional therapy. Contractors have the discretion to define what constitutes failure of conventional therapy; Conventional therapy is contraindicated. Contractors have the discretion to define what constitutes contraindications to conventional therapy; or Have rapidly progressive disease in which a clinical response could not be affected quickly enough using conventional agents. In these situations, IVIg therapy would be give along with conventional treatment(s) and the IVIg would be used only until conventional therapy could take effect.Note: In addition, IVIg for the treatment of autoimmune mucocutaneous blistering disease must be used only for short term therapy and not as a maintenance therapy. Again, contractors have the discretion to decide what constitutes short-term therapy.
Article - Billing and Coding: Intravenous Immune Globulin (IVIg)-NCD 250.3 (A54643)

CMS National Coverage PolicyCMS National Coverage Determination Manual, 250.3Article TextThis article describes CMS national coverage effective on/after October 1, 2001. Please see the Noridian Local Coverage Determination for additional indications.Patient must meet at least one of the following criteria: Failed conventional therapy. Contractors have the discretion to define what constitutes failure of conventional therapy; Conventional therapy is contraindicated. Contractors have the discretion to define what constitutes contraindications to conventional therapy; or Have rapidly progressive disease in which a clinical response could not be affected quickly enough using conventional agents. In these situations, IVIg therapy would be give along with conventional treatment(s) and the IVIg would be used only until conventional therapy could take effect.Note: In addition, IVIg for the treatment of autoimmune mucocutaneous blistering disease must be used only for short term therapy and not as a maintenance therapy. Again, contractors have the discretion to decide what constitutes short-term therapy.
Article - Billing and Coding: Coverage of Intravenous Immune Globulin for Treatment of Primary Immune Deficiency Diseases in the Home – Medicare Benefit Policy Manual, Chapter 15, 50.6 (A54660)

CMS National Coverage PolicyMedicare Benefit Policy Manual, Chapter 15, 50.6Article TextThis article describes CMS national coverage effective on/after January 1, 2004. Please see the Noridian Local Coverage Determination for additional indications at www.noridianmedicare.com.The Medicare Prescription Drug, Improvement, and Modernization Act of 2003 provides coverage of intravenous immune globulin (IVIG) for the treatment of primary immune deficiency diseases in the home if only an unspecified diagnosis is necessary). The Act defines intravenous immune globulin as an approved pooled plasma derivative for the treatment of primary immune deficiency disease. It is covered under this benefit when the patient has a diagnosed primary immune deficiency disease, it is administered in the home of a patient with a diagnosed primary immune deficiency disease, and the physician determines that administration of the derivative in the patients home is medically appropriate. The benefit does not include coverage for items or services related to the administration of the derivative. For coverage of IVIG under this benefit, it is not necessary for the derivative to be administered through a piece of durable medical equipment.
Article - Billing and Coding: Coverage of Intravenous Immune Globulin for Treatment of Primary Immune Deficiency Diseases in the Home – Medicare Benefit Policy Manual, Chapter 15, 50.6 (A54662)

CMS National Coverage PolicyMedicare Benefit Policy Manual, Chapter 15, 50.6Article TextThis article describes CMS national coverage effective on/after January 1, 2004. Please see the Noridian Local Coverage Determination for additional indications at www.noridianmedicare.com.The Medicare Prescription Drug, Improvement, and Modernization Act of 2003 provides coverage of intravenous immune globulin (IVIG) for the treatment of primary immune deficiency diseases in the home if only an unspecified diagnosis is necessary). The Act defines intravenous immune globulin as an approved pooled plasma derivative for the treatment of primary immune deficiency disease. It is covered under this benefit when the patient has a diagnosed primary immune deficiency disease, it is administered in the home of a patient with a diagnosed primary immune deficiency disease, and the physician determines that administration of the derivative in the patients home is medically appropriate. The benefit does not include coverage for items or services related to the administration of the derivative. For coverage of IVIG under this benefit, it is not necessary for the derivative to be administered through a piece of durable medical equipment.