evekhm/cms_iom_500 huggingface dataset:
Article - Billing and Coding: MolDX: Targeted and Comprehensive Genomic Profile Testing in Cancer (A56518)
Next 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 A59687for further guidance on the distinction between single analyte and panel tests.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 (A56518)
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.CPT coding InstructionsTargeted Tumor PanelsTo bill for DNA-based panels that measure specific SNVs, INDELs, CNVs or rearrangements, review CPT codes 81445 and 81450. If a DNA-based targeted panel meeting the coverage requirements is used, and MSI is also performed, 81457 can be billed. If a DNA-based targeted test meeting coverage requirements is performed that includes MSI and CNVs, 81458 can be billed.
Article - Billing and Coding: MolDX: Targeted and Comprehensive Genomic Profile Testing in Cancer (A56518)
81449 or 81451 for RNA-based targeted testing may also be billed for the same specimen that received a DNA-based NGS test if compliant with the language of A57503, is non-duplicative, and performed serially to DNA testing as a separate service (with a separate order and report). If only RNA-based testing is reasonable and necessary, 81449 or 81451 may be billed alone if policy requirements are met. If two targeted panels (one for DNA and the other for RNA) are always performed together and meet policy criteria, 81479 should be used for such a service to reduce claims processing errors as this would constitute one service.The unit of service (UOS) for an NGS gene panel is one (UOS=1). Providers must also provide the approved DEX Z-Codeidentifier for the test.Effective July 1, 2017, laboratories with 2 to 4 genes on their targeted NGS panel should use CPT 81479 and one(1) UOS along with their test identifier (DEX Z-Code) to represent this service on their claims.CGPCPT code 81459, based on the inclusion of the comprehensive test components addressed in the definition above, is considered a CGP test by this contractor and may be billed when all stated components of the service have satisfied technical assessment requirements. Because this code includes both DNA-only and DNA/RNA combined services in its description, it is assumed that services that include DNA/RNA combined testing add no additional relevant genomic information beyond that provided by a DNA-only test. For CGP tests that include the use of RNA to interrogate relevant genomic information beyond that captured with DNA-based testing, billing with CPT 81479 is appropriate. Additionally, if a service meets the definition of a CGP but NOT 81459, CPT code 81479 is appropriate.
Article - Billing and Coding: MolDX: Targeted and Comprehensive Genomic Profile Testing in Cancer (A56518)
Therefore, to report a CGP service, test providers should use CPT codes 81459 or 81479, in addition to the approved DEX Z-Codefor the test. Coverage of CGPs is limited to one test per surgical specimen and precludes the use of any further molecular testing on that specimen.For NGS-based tests that do not fit under the above definitions of targeted or Comprehensive panels, billing with the Not Otherwise Classified (NOC) code 81479 along with the approved DEX Z-Codeidentifier is appropriate.Tier 1 and/or Tier 2 individual biomarker CPT codes should not be used for a single gene or any combination of genes when testing is performed as part of a NGS or other multiplexing technology panel.Refer toBilling and Coding: MolDX: Next-Generation Sequencing for Solid Tumors A57905for CPT/HCPCS codes and ICD-10 codes relevant for solid tumors.Refer toBilling and Coding: MolDX: Next-Generation Sequencing Lab-Developed Tests for Myeloid Malignancies and Suspected Myeloid Malignancies A57892for CPT/HCPCS codes and ICD-10 codes relevant for myeloid malignancies.
Article - Billing and Coding: Octreotide Acetate for Injectable Suspension (Sandostatin® LAR Depot) (A56531)
CMS National Coverage PolicyTitle XVIII of the Social Security Act, 1833(e) prohibits Medicare payment for any claim which lacks the necessary information to process the claim.CMS Internet-Only Manual, Pub. 100-02, Medicare Benefit Policy Manual, Chapter 15, 50.3 Incident to Requirements, 50.4.3 Examples of Not Reasonable and Necessary, 50.4.4 Payment for Antigens and Immunizations, 50.4.4.2 Immunizations, 50.4.5 Off-Label Use of Drugs and Biologicals in an Anti-Cancer Chemotherapeutic Regimen, 50.4.5.1 Process for Amending the List of Compendia for Determination of Medically-Accepted Indications for Off-Label Uses of Drugs and Biologicals in an Anti-Cancer Chemotherapeutic Regimen, 50.4.6 Less Than Effective Drug and 50.4.7 Denial of Medicare Payment for Compounded Drugs Produced in Violation of Federal Food, Drug, and Cosmetic ActArticle TextThe information in this article contains billing, coding or other guidelines that complement the Local Coverage Determination (LCD) for Octreotide Acetate for Injectable Suspension (Sandostatin LAR Depot) L33438.When ICD-10-CM codes T38.895A, T38.895D, T38.895S, T43.215A, T43.215D, T43.215S, T43.225A, T43.225D, T43.225S, T50.995A, T50.995D or T50.995S is submitted for chemotherapy induced diarrhea (CID); the medical record must document the covered chemotherapy agent(s) causing the CID and the previous antidiarrheal treatments that have become ineffective.If ICD-10-CM codes C25.4, C26.0, D13.7, D13.91 and D13.99 are submitted on the claim, the medical record must document that the patients diagnosis is VIPoma.If ICD-10-CM code R79.89 is submitted on the claim, the patients record must document abnormal findings leading to suspicion of VIPoma.
Article - Billing and Coding: Octreotide Acetate for Injectable Suspension (Sandostatin® LAR Depot) (A56531)
If ICD-10-CM code R79.89 is submitted on the claim, the patients record must document abnormal findings leading to suspicion of VIPoma.If ICD-10-CM code R94.7 is submitted on the claim, the patients record must document an abnormal octreotide scan leading to suspicion of VIPoma.
Article - Billing and Coding: Minimally-Invasive Surgical (MIS) Fusion of the Sacroiliac (SI) Joint (A56535)
CMS National Coverage PolicyN/AArticle TextThis article gives guidance for billing, coding, and other guidelines in relation to local coverage policyL36494-Minimally-Invasive Surgical (MIS) Fusion of the Sacroiliac (SI) Joint.General Guidelines for Claims submitted to Part A or Part B MAC: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.
Article - Billing and Coding: Minimally-Invasive Surgical (MIS) Fusion of the Sacroiliac (SI) Joint (A56535)
Advance Beneficiary Notice of Non-coverage (ABN) Modifier GuidelinesAn ABN may be used for services which are likely to be non-covered, whether for medical necessity or for other reasons. Refer to CMS Publication 100-04, Medicare Claims Processing Manual, Chapter 30, for complete instructions.Effective from April 1, 2010, non-covered services should be billed with modifier GA, -GX, -GY, or GZ, as appropriate.The GA modifier (Waiver of Liability Statement Issued as Required by Payer Policy) should be used when physicians, practitioners, or suppliers want to indicate that they anticipate that Medicare will deny a specific service as not reasonable and necessary and they do have an ABN signed by the beneficiary on file. Modifier GA applies only when services will be denied under reasonable and necessary provisions, sections 1862(a)(1), 1862(a)(9), 1879(e), or 1879(g) of the Social Security Act. Effective April 1, 2010, Part A MAC systems will automatically deny services billed with modifier GA. An ABN, Form CMS-R-131, should be signed by the beneficiary to indicate that he/she accepts responsibility for payment. The -GA modifier may also be used on assigned claims when a patient refuses to sign the ABN and the latter is properly witnessed. For claims submitted to the Part A MAC, occurrence code 32 and the date of the ABN is required.Modifier GX (Notice of Liability Issued, Voluntary Under Payer Policy) should be used when the beneficiary has signed an ABN, and a denial is anticipated based on provisions other than medical necessity, such as statutory exclusions of coverage or technical issues. An ABN is not required for these denials, but if non-covered services are reported with modifier GX, will automatically be denied services.
Article - Billing and Coding: Minimally-Invasive Surgical (MIS) Fusion of the Sacroiliac (SI) Joint (A56535)
The GZ modifier should be used when physicians, practitioners, or suppliers want to indicate that they expect that Medicare will deny an item or service as not reasonable and necessary and they have not had an ABN signed by the beneficiary. If the service is statutorily non-covered, or without a benefit category, submit the appropriate CPT/HCPCS code with the -GY modifier. An ABN is not required for these denials, and the limitation of liability does not apply for beneficiaries. Services with modifier GY will automatically deny.Documentation RequirementsThe patients medical record should include but is not limited to:The assessment of the patient by the ordering provider as it relates to the complaint of the patient for that visit,Relevant 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.)
Article - Billing and Coding: Scanning Computerized Ophthalmic Diagnostic Imaging (SCODI) (A56537)
CMS National Coverage PolicyN/AArticle TextThis article contains coding and other guidelines that complement the Local Coverage Determination (LCD) for Scanning Computerized Ophthalmic Imaging (L34380).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.Documentation Requirements:The patient's medical record must contain documentation that fully supports the medical necessity for servicesincluded within the LCD. (See "Indications and Limitations of Coverage.") This documentation includes, but is not limited to, relevant medical history, physical examination, and results of pertinent diagnostic tests or procedures.
Article - Billing and Coding: Allergen Immunotherapy (A56538)
CMS National Coverage PolicyInternet-Only Manuals (IOMs)CMS IOM Publication 100-02,Medicare Benefit Policy Manual,Chapter 15, Sections 20.2 Physician Expense for Allergy Treatment and 50.4.4.1 AntigensCMS IOM Publication 100-04,Medicare Claims Processing Manual,Chapter 12, Section 200 Allergy Testing and ImmunotherapySocial 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.Article TextThis Billing and Coding Article provides billing and coding guidance for Local Coverage Determination (LCD) L36240 (Allergen Immunotherapy). Please refer to the LCD for reasonable and necessary requirements.Coding GuidanceNotice:It is not appropriate to bill Medicare for services that are not covered (as described by the entire LCD) as if they are covered. When billing for non-covered services, use the appropriate modifier.Please refer to the CMS IOM Publication 100-04,Medicare Claims Processing Manual,Chapter 12, Section 200 Allergy Testing and Immunotherapy for instructions on billing for allergy services.Documentation Requirements
Article - Billing and Coding: Allergen Immunotherapy (A56538)
Please refer to the CMS IOM Publication 100-04,Medicare Claims Processing Manual,Chapter 12, Section 200 Allergy Testing and Immunotherapy for instructions on billing for allergy services.Documentation RequirementsAll documentation must be maintained in the patient's medical record and made available to the contractor upon request.Every page of the record must be legible and include appropriate patient identification information (e.g., complete name, dates of service[s]). The documentation must include the legible signature of the physician or non-physician practitioner responsible for and providing the care to the patient.The submitted medical record should support the use of the selected ICD-10-CM code(s). The submitted CPT/HCPCS code should describe the service performed.Documentation of any therapeutic expectations, level of antigens, time frame for administration, and any adjustments to the expectation based on local reactions, systemic reactions, missed dosing will need to be very clear in the medical records.Documentation for all references to the therapeutic effective dose in the medical record should be referenced to the maintenance concentrate and should be noted as a volume-to-volume dilution (e.g., 1:100 vol/vol dilution of maintenance concentrate).In the event that allergen immunotherapy is administered to a patient in a home setting, medical record documentation must clearly demonstrate that the benefits of immunotherapy outweigh the risks, include a copy of the patients informed consent, and include validation regarding the training and ability of the individual administering the injection to recognize and manage immunotherapy reactions, particularly anaphylaxis.
Article - Billing and Coding: Prostate Rectal Spacers (A56539)
CMS National Coverage PolicyN/AArticle TextThis article contains coding and other guidelines that complement the Local Coverage Determination (LCD) forProstate Rectal Spacers.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.
Article - Billing and Coding: Biomarkers Overview (A56541)
CMS National Coverage PolicySocial 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.Article TextThis Billing and Coding Article provides billing and coding guidance for Local Coverage Determination (LCD) L35062 Biomarkers Overview. Please refer to the LCD for reasonable and necessary requirements.Coding GuidanceNotice: It is not appropriate to bill Medicare for services that are not covered (as described by the entire LCD) as if they are covered. When billing for non-covered services, use the appropriate modifier.It is the expectation, that when reporting ICD-10 codes the code representing the highest level of specificity documented in the medical record should be reported and unspecified codes should only be used when they are the code that most accurately reflects what is known about the patient's condition at the time of the encounter.Utilization ParametersCPT code 81490, Autoimmune (rheumatoid arthritis), is limited to two services per rolling year per beneficiary.Documentation RequirementsAll documentation must be maintained in the patient's medical record and made available to the contractor upon request.Every page of the record must be legible and include appropriate patient identification information (e.g., complete name, dates of service[s]). The documentation must include the legible signature of the physician or non-physician practitioner responsible for and providing the care to the patient.The submitted medical record must support the use of the selected ICD-10-CM code(s). The submitted CPT/HCPCS code must describe the service performed.
Article - Billing and Coding: BRCA1 and BRCA2 Genetic Testing (A56542)
CMS National Coverage PolicySocial 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.Article TextThis Billing and Coding Article provides billing and coding guidance for Local Coverage Determination (LCD) L36715, BRCA1 and BRCA2 Genetic Testing. Please refer to the LCD for reasonable and necessary requirements.Coding GuidanceNotice:It is not appropriate to bill Medicare for services that are not covered (as described by the entire LCD) as if they are covered. When billing for non-covered services, use the appropriate modifier.
Article - Billing and Coding: Cataract Extraction (A56544)
CMS National Coverage PolicyN/AArticle TextThis article contains coding and other guidelines that complement the local coverage determination (LCD) for Cataract Extraction.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.Pre or Postoperative CareIf there is no sharing of pre- or post-operative care, the surgeon should bill the CPT code(s) without the use of modifier(s) -54, -55 or 56. If the ophthalmologist shares post-operative care with another physician, modifier -54 (Surgical care only) must be appended to the procedure code for the operative date. Modifier -55 (Postoperative management only) must be appended for any dates of post-operative care.Anatomic ModifiersThe anatomic modifiers left (-LT) or right (-RT) should be appended to the procedure code.Cataract extractionWhen cataract extraction is necessary to affect an unimpeded view of the fundus for proper management of patients with disease of the posterior segment of the eye(s), physicians/providers must bill the appropriate cataract diagnosis code as primary and the posterior segment disease as the secondary diagnosis code.Documentation Requirements:The patient's medical record must contain documentation that fully supports the medical necessity for services included within this LCD. (See "Indications and Limitations of Coverage.") This documentation includes, but is not limited to, relevant medical history, physical examination, and results of pertinent diagnostic tests or procedures. The medical record and/or test results documenting medical necessity should be maintained and made available on request.