evekhm/cms_iom_500 huggingface dataset:
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.
Article - Billing and Coding: Neulasta® (pegfilgrastim) Onpro® Kit / UDENYCA® ONBODY™ (On-body Injector) (A54682)
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 TextNeulastaand UDENYCAare leukocyte growth factors indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.Neulastaand UDENYCAare currently available in 2 distinct delivery options. When administered to the patient by means of the prefilled syringe, the appropriate coding procedure is to report the HCPCS code for both the drug (J2506 or Q5111) and the administration of the drug (CPTcode 96372).Part B ProvidersWhen Neulastaor UDENYCAare administered to the patient by means of a pegfilgrastim injection device such as the NeulastaDelivery Kit (Onpro) or the UDENYCAONBODY, the provider does not inject the drug, but instead fills the injector device with the drug and applies the injector device to the patient. The drug is delivered to the patient approximately 27 hours after the activation of the injector device. No CPTcode specific to the procedure for employing the Onproexisted at the time of the introduction of this device. Providers were instructed to use CPTcode 96372 as an interim measure for reporting the administration of Neulastausing this drug delivery method. As of 1/1/2017, a new CPTcode (96377) became effective which specifically addresses the use of the Onpro/ONBODY device. Identify the injector device using CPTcode 96377 in the medical record to distinguish it from the use of theprefilled syringe which should be identified with CPTcode 96372.Outpatient Hospital Providers
Article - Billing and Coding: Neulasta® (pegfilgrastim) Onpro® Kit / UDENYCA® ONBODY™ (On-body Injector) (A54682)
Outpatient Hospital ProvidersThere has been no change to the information released in the Outpatient Hospital Final Rule for 2017:For Calendar Year 2017, CPTcode 96377 (Application of on-body injector (includes cannula insertion) for timed subcutaneous injection) is assigned status indicator N (Items and Services Packaged into APC Rates) to indicate that the service is paid under the Outpatient Prospective Payment System (OPPS). However, payment for the administration of NeulastaOnpro/UDENYCAONBODY is bundled into the payment for other services and not separately payable.
Article - Billing and Coding: MolDX: Arrhythmogenic Right Ventricular Dysplasia/Cardiomyopathy (ARVD/C) Testing (A54685)
CMS National Coverage PolicyN/AArticle TextEffective for dates of service on and after February 7, 2013ARVD/C, characterized by fatty replacement of heart cells predominantly in the right ventricle of the heart, is most often inherited as an autosomal dominant disease that may be associated with testing in at least seven genes (RYR2, TMEM43, DSP, PKP2, DSG2, DSC2 and JUP). Genetic testing may be performed in panels of 5-7 of these genes and disease-causing mutation is expected to be identified in 42-55% of cases. Testing would be performed to confirm an established diagnosis or on individuals already diagnosed with ARVD/C to identify family members at risk. Therefore, MolDX has determined that testing for ARVD/C is a statutorily excluded test.To receive an ARVD/C panel test denial, please submit the following claim information:CPTcode 81439An 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 modifierSelect the appropriate diagnosis for the patientEnter the appropriate DEX Z-codeTMidentifier adjacent to the CPT code in the comment/narrative field for the following claim field/types:Line SV202-7 for 837I Part A or Loop 2400 or SV101-7 for the 5010A1 837P for Part BBlock 80 for Part A or Box 19 for Part B paper claim
Article - Billing and Coding: MolDX: BCR-ABL (A54686)
CMS National Coverage PolicyN/AArticle TextEffective for dates of service on and after 4/15/13Breakpoint testing for BCR-ABL1 is commonly performed as a combination or panel of tests. To report multiple tests assigned a single ID, submit CPTcode 81479. This guideline includes the following CPTcode combinations:81206 and 8120781206, 81207, and 81208CPTcodes 81206, 81207, and 81208 may only be reported when performed as a single test.To submit a claim for BCR-ABL translocation analysis by NGS, use CPT81479 and one (1) UOS with the assigned DEX Z-code.To report the FDA-approved MRDx BCR-ABL Test use the CPTcode 0040U.Refer to Billing and Coding: MolDX: Testing of Multiple Genes A57910 for additional information regarding single-gene and panel testing of genes.
Article - Billing and Coding: MolDX: FDA-Approved KRAS Tests (A54688)
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 TextTwo tests have met the FDA criteria for KRAS genetic testing:Effective 7/6/2012therascreen KRAS to detect seven somatic mutations in the human KRAS oncogene was developed to aid in the identification of CRC patients for treatment with Erbitux (cetuximab).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 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 diagnosis.NOTE:MolDX will apply 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 the DEXTMDiagnostics Exchange:https://app.dexzcodes.com/loginThis 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: Germline testing for use of PARP inhibitors (A54689)
CMS National Coverage PolicyTitle XVIII of the Social Security Act (SSA) 1833(e) prohibits Medicare payment for any claim lacking the necessary documentation to process the claim.Article TextThe United States (U.S.) Food and Drug Administration (FDA) has approved several poly ADP-ribose polymerase (PARP) inhibitor treatments indicated for patients with ovarian cancer, breast cancer, pancreatic cancer, and prostate cancer.Results of tests that assess for deleterious variants in homologous recombination repair (HRR) genes such as BRCA1 and 2 can be used as an aid in patients who are being considered for treatment with PARP inhibitors in accordance with published guidelines and approved therapeutic product labeling. These genes are often tested as part of routine management of these cancer patients as part of services that interrogate a panel of genes as described in LCD L38966. In rare circumstances limited testing for only a select group of genes may be tested to ensure compliance with FDA indicated drug usage, wherein additional genes outlined in guidelines such as the NCCN are not necessary because the patient does not meet testing criteria for larger panels.According to criteria defined by L38966, billing for these services can occur in the following situation:The patient meets clinical indication for immediate use of a PARP inhibitor for an FDA-approved use ANDThe patient has had no previous germline testing for hereditary cancer or somatic testing of the same cancer that included the genes necessary for testing ANDThe patient does not meet germline testing requirements per existing guidelines or standards of care outlined in policy L38966 requiring more comprehensive testing.To report a service, please submit the following claim information:Select appropriate CPTcodeOne (1) unit of serviceEnter DEX Z-Code identifier adjacent to the CPTcode in the comment/narrative field for the following Part B claim field/types:Loop 2400 or SV101-7 for the 5010A1 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 formSelect at least one ICD-10-CM diagnosis code.
Article - Billing and Coding: FDA approves Iluvien for Diabetic Macular Edema (A54750)
CMS National Coverage PolicyN/AArticle TextOn September 26, 2014, The US Food and Drug Administration approved ILUVIEN (fluocinolone acetonide intravitreal implant) 0.19 mg for the treatment of diabetic macular edema (DME) in patients who have been previously treated with a course of corticosteroids and did not have a clinically significant rise in intraocular pressure. ILUVIEN is an intravitreal implant of fluocinolone acetonide and is the first DME treatment to deliver 36 months of continuous, low-dose corticosteroid with a single injection. The ILUVIEN intravitreal implant is designed to release fluocinolone acetonide/day at an initial rate of 0.25 g/day.To submit a Part B claim:Submit HCPCS code J7313 (fluocinolone acetonide intravitreal implant,0.19 mg )Total Dosage 0.19 mg, placed in narrative fieldOne of the ICD-10 diagnoses below.
Article - Billing and Coding: Medicare Preventive Coverage for Certain Vaccines (A54767)
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 TextMedicare provides preventive coverage only for certain vaccines. These include:Novel Coronavirus (COVID-19): guidance can be found here -https://www.cms.gov/medicare/medicare-part-b-drug-average-sales-price/vaccine-pricingInfluenza: once per flu season (codes 90630, 90653-90657, 90660-90662, 90672-90674, 90682, 90685-90689, 90694, 90756, Q2034-Q2039)Claim should contain HCPCS G0008 and ICD-10 Z23Effective for dates of service 8/01/2017-12/31/2017 claims for Flucelvax Quadrivalent influenza vaccine should be billed utilizing HCPCS Q2039 (Influenza virus vaccine, not otherwise specified).Note:Claims billed for dates of service prior to 12/31/2017, if submitted on or after 01/01/2018, must bill HCPCS Q2039 for the claim to process correctly.Note:CPTcode 90694 is effective for claims processed with dates of service on or after 7/1/2020.Pneumococcal: An initial pneumococcal vaccine to Medicare beneficiaries who have never received the vaccine under Medicare Part B; and a different, second pneumococcal vaccine 1 year after the first vaccine was administered (codes 90670, 90671, 90677 and 90732)Claim should contain HCPCS G0009 and ICD-10 Z23Pneumococcal and Seasonal Influenza Virus Vaccines received during the same visit (use seasonal influenza virus and pneumococcal vaccine codes)Claim should contain HCPCS G0008 AND G0009 AND ICD-10 Z23Hepatitis B: for persons at intermediate-to high-risk only (codes 90739-90740, 90743-90744, 90746-90747, 90759). People who are considered high or medium risk for hepatitis B are:
Article - Billing and Coding: Medicare Preventive Coverage for Certain Vaccines (A54767)
Those with End-Stage Renal Disease (ESRD) also known as kidney failureHemophiliacsClients and staff at institutions for the developmentally disabledThose who live in the same household as a hepatitis B carrierHomosexual menIllicit drug usersHealth care professionals who have frequent contact with blood or other body fluids during routine work-Claim should contain HCPCS G0010 and ICD-10 Z23Other immunizations are covered under Medicare only if they are directly related to the treatment of an injury or direct exposure:Rabies (90675-90676)Claim should contain Z20.3Tetanus (90702, 90714, and 90715)Claims should be coded with the diagnosis appropriate to the injury- see theICD-10-CM Codes that Support Medical Necessitysection of this article.
Article - Billing and Coding: Cardiac Blood Pool Imaging (Multiple Gated Acquisition Scanning- MUGA, Ventriculography) When Performed in Conjunction with Cardiotoxic Chemotherapy (A54768)
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 TextVentriculography is sometimes referred to as multiple gated acquisition scanning (MUGA) or cardiac blood pool imaging and is primarily used to evaluate valvular disease and cardiomyopathies.When billing claims for cardiac radionuclide imaging for cardiac blood pool imaging (MUGA, ventriculography) for patients receiving cardiotoxic chemotherapy, use the following CPTcodes:78472, 78473, 78481, 78483, 78494, 78496Coding for Cardiac Blood Pool Imaging (MUGA, Ventriculography) for Cardiac Radionuclide Imaging:Priorto the initiation of cardiotoxic chemotherapy:Code Z01.89 and the appropriate code from the C code or D code familyDuring or for interval assessmentof cardiotoxic chemotherapy use the appropriate code for the encounter:T45.1X5AT45.1X5DT45.1X5SAt the completionof cardiotoxic chemotherapy:Code Z08Use the additional secondary code to identify the personal history of malignant neoplasm (Z85) as per Correct Coding Initiative (CCI) guidelines and the appropriate code from the C code or D code family.*For appropriate C codes, D codes and appropriate Z85 codes for billing cardiac blood pool imaging (MUGA, ventriculography) refer to theCovered ICD-10 Codessection of this article.
Article - Billing and Coding: Influenza Diagnostic Tests (A54769)
CMS National Coverage PolicyTitle XVIII of the Social Security Act (SSA) 1833(e) prohibits Medicare payment for any claim lacking the necessary documentation to process the claimArticle TextTo avoid the overuse of antibiotics and the potential risk of antibiotic resistance, point of care providers should consider testing patients prior to prescribing treatment for a bacterial or influenza infection. Influenza testing (using molecular methods) is recommended for hospitalized patients with suspected influenza. However, testing is not needed for all outpatients with signs and symptoms consistent with influenza before making antiviral treatment decisions, particularly once influenza activity has been documented in the community. The following summary provides a list of the main available types of diagnostics tests:Rapid Antigen Tests:Availableat the point of careYieldsa Flu A and Flu B result in < 30 minutesLess sensitive (50%-70%) and specific (90%-95%) compared to other methods and may require confirmation byreverse transcription-polymerase chain reaction (RT-PCR) or viral culture.Note:the Food and Drug Administration (FDA) now requires that all Rapid influenza diagnostic tests (RIDTs) achieve 80% or higher sensitivity compared with RT-PCR.Centers for Disease Control and Prevention (CDC) recommendations:Use rapid diagnostic tests with high sensitivity and specificity.Collect respiratory tract specimens as early in the illness as possible (within 3-4 days of illness onset).Follow manufacturers instructions, including handling of respiratory specimens, as described in the device package insert.Consider sending respiratory specimens (from symptomatic patients) for RT-PCR to confirm results of RIDTs, especially in the following situations:When community influenza activity is low and the rapid diagnostic test result is positive.When community influenza activity is high and the rapid diagnostic test result is negative.Contact your local or state health department for information about influenza activity.A patient has had recent close exposure (this does NOT include eating cooked meat) to pigs or birds (including poultry) or other animals, and there is concern for infection with a novel influenza A virus.Targeted Molecular Methods:
Article - Billing and Coding: Influenza Diagnostic Tests (A54769)
A patient has had recent close exposure (this does NOT include eating cooked meat) to pigs or birds (including poultry) or other animals, and there is concern for infection with a novel influenza A virus.Targeted Molecular Methods:UsesRT-PCR or other amplification methods to detect viral nucleic acidsResults available in < 24 hours (often in less than 2-4 hours)Detects from 1-2 to up to 20 respiratory pathogens from 1 specimenA positive result (on testing of an upper respiratory tract specimen) in a person who recently received intranasal administration of live attenuated influenza virus vaccine (LAIV) may indicate detection of vaccine virus.Viral Culture:Confirms present active infectionResults available in 3-10 daysMissesopportunity for Oseltamivir (Tamiflu) treatment for positive patientsImmunofluorescence (IF) - Direct (DFA) or Indirect (IFA) Fluorescent Antibody Staining (antigen detection):Moderatesensitivity and high specificityResults available in approximately 2-4 hoursIf a rapid antigen test is performed and then confirmed using PCR, the second test may require the -59 modifier.If a CLIA-waived test is performed, the -QW modifier should be reported for the waived test.Reference:Centers for Disease Control and Prevention.Information for Clinicians on Rapid Diagnostic Testing for Influenza. Accessed 4/27/21.
Article - Billing and Coding: MolDX: Targeted and Comprehensive Genomic Profile Testing in Cancer (A54795)
CMS National Coverage PolicyN/AArticle TextNext Generation Sequencing (NGS)NGS allows identification of somatic and/or germline alterations in multiple genes simultaneously. This guideline focuses on Targeted and Comprehensive Genomic Profile testing for somatic variant detection using tumor-based panels for cancer that may be performed by NGS.Refer toMolDX: Defining panel services in MolDX A59678for further guidance on the distinction between single analyte and panel tests.
Article - Billing and Coding: MolDX: Targeted and Comprehensive Genomic Profile Testing in Cancer (A54795)
Definitions:Targeted Tumor PanelsTargeted tumor panels are hereby defined as tests that identify somatic alterations known to occur in certain regions (i.e.,'hotspots') within specific genes of interest for cancer management (i.e., diagnosis, selection of molecularly targeted therapies, prognosis in a context where prognostic classification is essential for treatment selection). Generally, these panels are limited to specific variant types at defined sites, such as single nucleotide variants (SNVs), small insertions or deletions (INDELs), single site copy number variants, or gene fusions. These alterations typically represent response or lack of response to corresponding targeted cancer therapies. The hotspot test should include relevant targets required for companion diagnostic testing and/or known to be necessary for proper patient management.Comprehensive Genomic Profile (CGP) Testing
Article - Billing and Coding: MolDX: Targeted and Comprehensive Genomic Profile Testing in Cancer (A54795)
Comprehensive Genomic Profile (CGP) TestingCGP testing refers to NGS-based molecular assays that provide additional insight beyond individual gene hotspots; these assays seek to describe the genomic makeup of a tumor and can help identify underlying mechanisms of disease to guide clinical decision making. These tests include not only mutations in individual relevant genes, but also patterns of mutations across related genes in established cancer pathways and often include an assessment of overall mutational burden. These tests typically involve sequencing of entire exonic regions of genes of interest within a comprehensive gene panel or whole exome sequencing and may also include select intronic regions. CGP tests can detect multiple types of molecular alterations (i.e., SNVs, small and large INDELs, copy number variants (CNVs), structural variants (SVs), and splice-site variants) in a single assay. Patterns of mutations seen across multiple genes may be used to infer clinically relevant etiologies, such as DNA mismatch repair deficiency and microsatellite instability (MSI), total mutational load/burden (TMB) and chromosome abnormalities such as loss of heterozygosity (LOH). CGP testing may also include RNA sequencing to detect structural variations, such as translocations or large deletions, and to detect functional splicing mutations. CGP testing is not defined as a targeted panel by MolDX. CGP tests are expected to yield information of clinical relevance beyond a targeted panel, for example, to identify relevant clinical trials for patient management or identify possible therapeutic interventions for off-label use. It is expected that a CGP will identify all clinically relevant information attainable for the type of service performed.