evekhm/cms_iom_500 huggingface dataset:
Article - Billing and Coding: Off-label Use of Rituximab and Rituximab Biosimilars (A59101)
CMS National Coverage PolicyTitle XVIII of the Social Security Act, Section 1833(e) prohibits Medicare payment for any claim lacking the necessary documentation to process the claimCMS Manual System, Pub 100-04,Medicare Claims Processing Manual, Change Request 10530, Transmittal 3996 dated March 9, 2018CMS Internet-Only Manual, Pub 100-04,Medicare Claims Processing Manual, Chapter 17, Section 40 Discarded Drugs and BiologicalsArticle TextThis article contains coding and other guidelines that complement the Local Coverage Determination (LCD) for Off-label Use of Rituximab and Rituximab Biosimilars which addresses off-label use of rituximab.This article defines off-label, non-compendia approved, uses for Rituximab.However, for the convenience of providers, we have added a list of labeled and compendia approved diagnoses in the Group 2 section for ICD-10-CM Codes that Support Medical Necessity below.Coding Information:Procedure codes may be subject to National Correct Coding Initiative (NCCI) edits or OPPS packaging edits. Refer to NCCI and OPPS requirements prior to billing Medicare.For services requiring a referring/ordering physician, the name and NPI of the referring/ordering physician must be reported on the claim.A claim submitted without a valid ICD-10-CM diagnosis code will be returned to the provider as an incomplete claim under Section 1833(e) of the Social Security Act.The diagnosis code(s) must best describe the patient's condition for which the service was performed. For diagnostic tests, report the result of the test if known; otherwise the symptoms prompting the performance of the test should be reported.Documentation Requirements:If a patient is treated with rituximab, they are expected to be treated with the standard doses per medical literature for the condition. After the initial treatment, re-treatment requires a positive response to rituximab documented in the medical record.The patients medical record should include but is not limited to:
Article - Billing and Coding: Off-label Use of Rituximab and Rituximab Biosimilars (A59101)
The assessment of the patient by the ordering provider as it relates to the complaint of the patient for that visitRelevant medical historyResults of pertinent tests/proceduresSigned and dated office visit record/operative report (Please note that all services ordered or rendered to Medicare beneficiaries must be signed)Previous treatments including dosing and frequency of treatments, duration of treatment and documentation of responseDuration of disease course and response to previous treatment if applicableIf use is due to:Lack of efficacy of prior treatments, documentation of prior treatment(s) must include dosing, frequency of dosing, duration of treatment(S) and documentation of response(s).Adverse reaction to first-line therapy, documentation must include the event which absolutely contraindicates further use of the medication, or side effects that are not likely to be transient and resolve with further treatment, or that impair functional capacity and/or activities of daily living.Refractory disease, documentation must include all first-line treatment(s), dosing, frequency of dosing, duration of treatment(S) and documentation of response(s).Relapse in disease course, documentation must include prior first-line treatment(s), dosing, frequency of dosing, duration of each treatment(s), and duration of improvement on prior treatment(s). Pertinent clinical history, exam findings and test results that support relapse in disease course should be documented. Documentation of response treatment(s) at time of relapse, including duration, dosing and response to subsequent treatment(s).Re-treatment, then documentation of positive response to prior treatment must be included.
Draft Article - Billing and Coding: MolDX: Prognostic and Predictive Molecular Classifiers for Bladder Cancer (DA58028)
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.CMS Internet-Only Manual, Publication 100-02, Medicare Benefit Policy Manual, Chapter 15,80.1.2 A/B MAC (B) Contacts With Independent Clinical LaboratoriesArticle TextThe information in this article contains billing, coding, or other guidelines that complement the Local Coverage Determination (LCD) for MolDX: Prognostic and Predictive Molecular Classifiers for Bladder Cancer DL38576.To report a service, please submit the following claim information:Select the appropriate CPTcodeEnter 1 unit of service (UOS)Enter the appropriate 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 the appropriate 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 the appropriate ICD-10-CM code
Article - Billing and Coding: Off-Label Use of Intravenous Immune Globulin (IVIG) (A59105)
CMS National Coverage PolicyLanguage quoted from Centers for Medicare and Medicaid Services (CMS), National Coverage Determinations (NCDs) and coverage provisions in interpretive manuals is italicized throughout the policy. NCDs and coverage provisions in interpretive manuals are not subject to the LCD Review Process (42 CFR 405.860[b] and 42 CFR 426 [Subpart D]). In addition, an administrative law judge may not review an NCD. See Section 1869(f)(1)(A)(i) of the Social Security Act.Unless otherwise specified,italicizedtext represents quotation from one or more of the following CMS sources:Title XVIII of the Social Security Act (SSA):Section 1862(a)(1)(A) excludes expenses incurred for items or services which are not reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member.Section 1833(e) prohibits Medicare payment for any claim which lacks the necessary information to process the claim.CMS PublicationsCMS Publication Pub 100-02,Medicare Benefit Policy Manual,Chapter 15:50 - Drugs and Biologicals50.4.5 - Off-Label Use of Drugs and Biologicals in an Anti-Cancer Chemotherapeutic RegimenCMS Publication 100-04,Medicare Claims Processing Manual,Chapter 17:10 - Payment Rules for Drugs and BiologicalsArticle TextThis article contains coding or other guidelines that complement the local coverage determination (LCD) for Off-Label Use of Intravenous Immune Globulin (IVIG). The use of IVIG for labeled indications is not addressed in this article.The LCD and this article address off-label uses for IVIG. We define off-label as not in Medicare approved compendia or in the FDA label.However, for the convenience of providers, we have added a list of labeled and compendia approved diagnoses in the Group 2 section for ICD-10-CM Codes that Support Medical Necessity below.Coding Information:Procedure codes may be subject to National Correct Coding Initiative (NCCI) edits or OPPS packaging edits. Refer to NCCI and OPPS requirements prior to billing Medicare.For services requiring a referring/ordering physician, the name and NPI of the referring/ordering physician must be reported on the claim.
Article - Billing and Coding: Off-Label Use of Intravenous Immune Globulin (IVIG) (A59105)
For services requiring a referring/ordering physician, the name and NPI of the referring/ordering physician must be reported on the claim.A claim submitted without a valid ICD-10-CM diagnosis code will be returned to the provider as an incomplete claim under Section 1833(e) of the Social Security Act.The diagnosis code(s) must best describe the patient's condition for which the service was performed.Specific coding guidelines for this policy:When administering IVIG to patients over continuous days, providers should report each days dosage on a separate line of coding, using the appropriate date of service with the units reported in the NOS field of the claim form.When separately identifiable evaluation and management services are provided and documented on the same day as intravenous administration, they may be billed using modifier 25.For claims submitted to the Part B MAC:All services/procedures performed on the same day for the same beneficiary by the physician/provider should be billed on the same claim.Utilization:The dose and frequency of administration should be consistent with the FDA approved package insert. When dose and/or frequency are different from the FDA approved package insert, literature support for the specific schedule chosen should be available.Claims submitted for procedures performed at unusually frequent intervals or high dosages may be reviewed for medical necessity. If coverage of IVIG is denied, the administration and pre-administration services associated with IVIG will also be denied.Documentation Requirements:Medical record documentation maintained by the treating physician must clearly document the medical necessity to initiate intravenous immune globulin therapy and the continued need thereof. Required documentation of medical necessity should include:history and physical;office/progress notes(s);test results with written interpretation;accurate weight in kilograms should be documented prior to the infusion, since the dosage is based on a mg/kg dosage;documentation of prior treatment therapies (where appropriate or referenced by this policy);evidence of blood level results demonstrating a significant deficiency in gammaglobulin levels prior to initial treatment (where appropriate or referenced by this policy);history of recurrent and severe infections;current effectiveness of IVIG therapy; andgoals and/or treatment plan
Article - Billing and Coding: Off-Label Use of Intravenous Immune Globulin (IVIG) (A59105)
Diagnostic testing appropriate for the condition under treatment should be documented, and this may include nerve conduction study (NCS), electromyography (EMG), cerebral spinal fluid (CSF), serum immunoprotein, or biopsy (muscle-nerve). The reason for choosing IVIG as a treatment must be well supported on review of records. Previous treatment failures with alternative agents should be documented.When used for neuromuscular disorders, when there is improvement and continued treatment is necessary, then quantitative assessment to monitor progress is required. Quantitative monitoring may use any accepted measure, such as medical research council (MRC) scale and activities of daily living (ADL) measurements. Changes in these measures must be clearly documented. Subjective or experiential improvement alone is insufficient to support continued use of IVIG.When used for chronic neuromuscular or immunologic conditions, there should be an attempt made to wean the dosage when improvement has occurred and an attempt to discontinue IVIG infusion when improvement is sustained with dosage reduction. In addition, when improvement does not occur with IVIG, then continued infusion would not be considered reasonable or necessary.When used for recurrent severe infection and documented severe deficiency or absence of IgG subclass deficiency, a serum IgG subclass trough level should be monitored at least every three months prior to the dose of intravenous immune globulin, along with clinical progress of signs and symptoms for which intravenous immune globulin therapy is required.When used for clinically significant functional deficiency of humoral immunity as evidenced by documented failure to produce antibodies to specific antigens and a history of recurrent infections, the deficient antibody(ies) should be monitored at least every 3 months, prior to the dose of intravenous immune globulin, along with clinical progress of signs and symptoms for which intravenous immune globulin therapy is required.When used for the treatment of autoimmune mucocutaneous blistering disease please refer to CMS Publication 100-03,Medicare National Coverage Decisions Manual, Chapter 1, Section 250.3.
Article - Billing and Coding: Off-Label Use of Intravenous Immune Globulin (IVIG) (A59105)
When used for the treatment of autoimmune mucocutaneous blistering disease please refer to CMS Publication 100-03,Medicare National Coverage Decisions Manual, Chapter 1, Section 250.3.When used for bone marrow/stem cell transplantation, a) the recipient was seropositive for cytomegalovirus (CMV) before transplantation or b) after allogeneic transplantation for hematologic neoplasm when the donor(s) and recipient were seronegative.When used for solid organ transplantation, the donor was seropositive and the recipient was seronegative for cytomegalovirus (CMV) before transplantation.Documentation must be available to Medicare upon request.FDA and Compendia Review:American Society of Health-System Pharmacists, Inc.AHFS Drug Information.Bethesda, MD:2007Clinical Pharmacology Web site. http://www.clinicalpharmacology.com/. Accessed 04/22/2022.
Article - Billing and Coding: Off-Label Use of Intravenous Immune Globulin (IVIG) (A59105)
FDA label information:Bivigam [Product Information]. Boca Raton, FL. Biotest Pharmaceuticals Corporation. September 23, 2013. Available at: Bivigam-FDA.Accessed on May 17, 2019.Flebogamma 5% DIF [Product Information]. Los Angeles, CA. Grifols Biologicals, Inc. September 23, 2013. Available at: Flebogamma-FDA. Accessed on May 17, 2019.Gammagard Liquid [Product Information]. Westlake Village, CA. Baxter Healthcare Corporation. September 23, 2013. Available at: Gammagard Liquid-FDA. Accessed on May 17, 2019.Gammaked [Product Information]. Research Triangle Park, NC. Talecris Biotherapeutics, Inc. September 2013. Available at: http://www.gammaked.com/filebin/pdf/2013-09-gammaked.pdf. Accessed on May 17, 2019.Gammaplex [Product Information]. Temecula, CA. FFF Enterprises, Inc. September 23, 2013. Available at: Gammaplex-FDA. Accessed on May 17, 2019.Gamunex-C [Product Information]. Research Triangle Park, NC. Talecris Biotherapeutics, Inc. September 23, 2013. Available at: Gamunex-C-FDA. Accessed on May 17, 2019.Octagam [Product Information]. Centreville, VA. Octapharma USA, Inc. July 11, 2014. Available at: Octagam-FDA. Accessed on May 17, 2019.Privigen [Product Information]. Kankakee, IL. CSL Behring, LLC. September 23, 2013. Available at: Privigen-FDA. Accessed on May 17, 2019Asceniv Available at: Asceniv-FDA. Accessed on December 12/09/2020.
Article - Billing and Coding: Off-Label Use of Intravenous Immune Globulin (IVIG) (A59105)
Lexi-Drugs Web site. http://online.lexi.com/lco/action/home. Accessed 04/22/2022.Micromedex DrugDex Thomson Web site. http://www.thomsonhc.com/home/dispatch. Accessed 04/22/2022.National Comprehensive Cancer Network Web site. http://www.nccn.org/index.asp. Accessed 04/22/2022.U.S. Food and Drug Administration label accessed on line at http://www.accessdata.fda.gov/scripts/cder/drugsatfda/ on 07/11/2007.
Draft Article - Billing and Coding: MolDX: Molecular Assays for the Diagnosis of Cutaneous Melanoma (DA59109)
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 claimCMS Internet-Only Manuals, 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, 60.1.2 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 TextThe information in this article contains billing, coding or other guidelines that complement the Local Coverage Determination (LCD) for MolDX: Molecular Assays for the Diagnosis of Cutaneous Melanoma.Please submit the following claim information:Regarding the myPathMelanoma assay:Select CPT code 81479 for dates of service prior to 7/1/2019Select proprietary CPT code 0090U for dates of service on or after 7/1/2019Regarding other molecular assays for the diagnosis of cutaneous melanoma:Select CPT code 81479 if there is not an applicable CPT or PLA code listed belowOnly 1 test may be billed per patient per melanocytic lesion.Enter 1 unit of service (UOS)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 code
Article - Billing and Coding: MolDX: Molecular Assays for the Diagnosis of Cutaneous Melanoma (A59109)
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 claimCMS Internet-Only Manuals, 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 TextThe information in this article contains billing, coding or other guidelines that complement the Local Coverage Determination (LCD) for MolDX: Molecular Assays for the Diagnosis of Cutaneous Melanoma.Please submit the following claim information:Regarding the myPathMelanoma assay:Select CPTcode 81479 for dates of service prior to 7/1/2019Select proprietary CPTcode 0090U for dates of service on or after 7/1/2019Regarding other molecular assays for the diagnosis of cutaneous melanoma:Select CPTcode 81479 if there is not an applicable CPT or PLA code listed belowOnly 1 test may be billed per patient per melanocytic lesion.Enter 1 unit of service (UOS)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 formSelect the appropriate ICD-10-CM code
Draft Article - Billing and Coding: MolDX: Prognostic and Predictive Molecular Classifiers for Bladder Cancer (DA58065)
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.CMS Internet-Only Manual, Publication 100-02, Medicare Benefit Policy Manual, Chapter 15, 80.1.2 A/B MAC (B) Contacts With Independent Clinical LaboratoriesArticle TextThe information in this article contains billing, coding, or other guidelines that complement the Local Coverage Determination (LCD) for MolDX: Prognostic and Predictive Molecular Classifiers for Bladder Cancer DL38586.To report a service, please submit the following claim information:Select the appropriate CPT codeEnter 1 unit of service (UOS)Enter the appropriate 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 the appropriate 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 the appropriate ICD-10-CM code
Article - Billing and Coding: MolDX: Molecular Testing for Detection of Upper Gastrointestinal Metaplasia, Dysplasia, and Neoplasia (A59121)
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 Manuals, Pub 100-02, Medicare Benefit Policy Manual, Chapter 15, 80.1.2 A/B MAC (B) Contacts With Independent Clinical Laboratories.Article TextThe information in this article contains billing, coding or other guidelines that complement the Local Coverage Determination (LCD) for MolDX: Molecular Testing for Detection of Upper Gastrointestinal Metaplasia, Dysplasia, and Neoplasia.To receive a denial, please submit the following claim information:Select appropriate CPT codeEnter 1 unit of service (UOS)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 code
Draft Article - Billing and Coding: Genetic Testing for Oncology (DA59123)
CMS National Coverage PolicyInternet-Only Manuals (IOMs)CMS IOM Publication 100-04,Medicare Claims Processing Manual,Chapter 16, Section 10 Background, Section 40.8 Date of Service (DOS) for Clinical Laboratory and Pathology Specimens and Section 120.1 Negotiated Rulemaking ImplementationChapter 18 Preventive and Screening ServicesCMS IOM Publication 100-08,Medicare Program Integrity Manual,Chapter 3 Verifying Potential Errors and Taking Corrective ActionsSocial Security Act (Title XVIII) Standard References:Title XVIII of the Social Security Act, Section 1833(e) states that no payment shall be made to any provider of services or other person under this part unless there has been furnished such information as may be necessary in order to determine the amounts due such provider or other person under this part for the period with respect to which the amounts are being paid or for any prior period.Code of Federal Regulations (CFR) References:CFR, Title 42, Subchapter B, Part 410 Supplementary Medical Insurance (SMI) Benefits, Section 410.32 Diagnostic x-ray tests, diagnostic laboratory tests, and other diagnostic tests: ConditionsCFR, Title 42, Section 414.502 DefinitionsCFR, Title 42, Subpart G, Section 414.507 Payment for clinical diagnostic laboratory tests and Section 414.510 Laboratory date of service for clinical laboratory and pathology specimensCFR, Title 42, Part 493 Laboratory RequirementsCFR, Title 42, Section 493.1253 Standard: Establishment and verification of performance specificationsCFR, Title 42, Section 1395y(b)(1)(F) Limitation on beneficiary liabilityNational Correct Coding Initiative (NCCI) Policy Manual for Medicare Services:Chapter 10, Section F Molecular PathologyChapter 10, Section M Medically Unlikely Edits (MUEs)Article TextThis Billing and Coding Article provides billing and coding guidance for Proposed Local Coverage Determination (LCD) DL39367 Genetic Testing for Oncology. Please refer to the LCD for reasonable and necessary requirements.