evekhm/cms_iom_500 huggingface dataset:
Article - Billing and Coding: Hypoglossal Nerve Stimulation for Obstructive Sleep Apnea (A58075)
The information in this article contains billing, coding or other guidelines that complement the Local Coverage Determination (LCD) forHypoglossal Nerve Stimulation for Obstructive Sleep Apnea L38276.General Guidelines for Claims submittedfor Part A or Part B Services: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.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.
Article - Billing and Coding: Hypoglossal Nerve Stimulation for Obstructive Sleep Apnea (A58075)
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 theydo havean 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 provisionsotherthan 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, Part A MAC systems will automatically deny the services.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 theyhave nothad 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.New implantation of a Hypoglossal Nerve Stimulator (HNS) for treatment of OSA code:
Article - Billing and Coding: Hypoglossal Nerve Stimulation for Obstructive Sleep Apnea (A58075)
CPTcode 64582- Insertion of hypoglossal nerve stimulator electrode and generator and breathing sensor electrode.Revision or replacementduring the life cycle of HNS components for treatment of OSA is reported with one or more of the following (as applicable):CPTcode 64583- Revision or replacement of hypoglossal nerve stimulator electrode and breathing sensor electrode with connection to existing generator *CPTcode 61886- (For a generator replacement): Insertion or replacement of cranial neurostimulator pulse generator or receiver, direct or inductive coupling; with connection to 2 or more electrode arraysCPTcode 61888- (For a generator revision): Revision or removal of cranial neurostimulator pulse generator or receiver* Append modifier 52 in instances where only a portion of the device listed in the description is revised (e.g., revision of breathing sensor lead only or revision of stimulation lead only)Removalof component(s) of a HNS for treatment of OSA is reported with one or more of the following (as applicable):CPTcode 64584- Removal of hypoglossal nerve neurostimulator electrode and generator and breathing sensor electrode ** Append modifier 52 in instances where only a portion of the device listed in the description is revised (e.g., removal of generator only or both generator and stimulation lead or breathing sensor lead only or stimulation lead only)Documentation RequirementsThe patient's medical record must contain documentation that fully supports the medical necessity for services included within theCoverage Indications, Limitations and/or Medical Necessitysection within the related LCD. This documentation includes, but is not limited to, appropriate use criteria, relevant medical history, physical examination, and results of pertinent diagnostic tests or procedures.The patients medical record must document all of the following:SymptomsPolysomnography reportingDrug Induced Sleep Endoscopy (DISE) reporting-CPT code 42975Body mass index
Article - Billing and Coding: Hypoglossal Nerve Stimulation for Obstructive Sleep Apnea (A58075)
SymptomsPolysomnography reportingDrug Induced Sleep Endoscopy (DISE) reporting-CPT code 42975Body mass indexReplacement or revision of an implanted neurostimulator pulse generator system (with or without lead changes) for hypoglossal nerve stimulation is considered medically necessary inan individual when the implantation occurred because the LCD coverage criteria were met.Utilization GuidelinesIn accordance with CMS Ruling 95-1 (V), utilization of these services should be consistent with locally acceptable standards of practice.
Article - Billing and Coding: Non-Invasive Fractional Flow Reserve (FFR) for Ischemic Heart Disease (A58095)
CMS National Coverage PolicyN/AArticle TextThe information in the Supplemental Instructions Article contains billing, coding, or other guidelines that complement the Noridian Local Coverage Determination for Non-Invasive Fractional Flow Reserve (FFR) for Ischemic Heart Disease L38613.Procedure codes may be subject to National Correct Coding Initiative edits or OPPS packaging edits. Refer to NCCI and OPPS requirements prior to billing Medicare.As this service constitutes post-procedure analysis of a previously performed study (CCTA), the name and National Provider Identifier (NPI) of the referring/ordering physician that submitted imaging data for FFRct review must be reported on the claim.An Advance Beneficiary Notice (ABN) of non-coverage may be used for services that 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 30for complete instructions.The patients medical record must document all of the following:The clinical findings that led to the initial performance of the CCTA, and the CCTA must be fully reviewed before the performance of FFRct. (as evidenced by the submission of the Coronary Computed Tomographic Angiography Report)Description of symptoms consistent with stable ischemic heart disease.Body mass indexFractional Flow Reserve analysis report
Article - Billing and Coding: Non-Invasive Fractional Flow Reserve (FFR) for Ischemic Heart Disease (A58097)
CMS National Coverage PolicyN/AArticle TextThe information in the Supplemental Instructions Article contains billing, coding, or other guidelines that complement the Noridian Local Coverage Determination LCD for Non-Invasive Fractional Flow Reserve (FFR) for Ischemic Heart Disease L38615.Procedure codes may be subject to National Correct Coding Initiative edits or OPPS packaging edits. Refer to NCCI and OPPS requirements prior to billing Medicare.As this service constitutes post-procedure analysis of a previously performed study (CCTA), the name and National Provider Identifier (NPI) of the referring/ordering physician that submitted imaging data for FFRct review must be reported on the claim.An Advance Beneficiary Notice (ABN) of non-coverage may be used for services that 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 30for complete instructions.The patients medical record must document all of the following:The clinical findings that led to the initial performance of the CCTA, and the CCTA must be fully reviewed before the performance of FFRct. (as evidenced by the submission of the Coronary Computed Tomographic Angiography Report).Description of symptoms consistent with stable ischemic heart disease.Body mass index.Fractional Flow Reserve analysis report.
Article - Billing and Coding: Implantable Continuous Glucose Monitors (I-CGM) (A58110)
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) L38617 Implantable Continuous Glucose Monitors (I-CGM). 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.When coding 0446T, 0447T, and 0448T they are in relation to the 90 day monitors.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 - Off-Label Use of Drugs and Biologicals for Anti-Cancer Chemotherapeutic Regimen (A58113)
CMS National Coverage PolicyN/AArticle Text
Article - Off-Label Use of Drugs and Biologicals for Anti-Cancer Chemotherapeutic Regimen (A58113)
Off-label (unlabeled) drug is defined as a use for a non-FDA approved indication that is not listed on the drug's official label/prescribing information. Off-label use is further defined as giving the drug in a way that deviates significantly from the labeled prescribing information for a particular indication. This includes but is not necessarily limited to, dosage, route of administration, duration, and frequency of administration, and population to whom the drug would be administered.Indication is defined as a diagnosis, illness, injury, syndrome, condition, or other clinical parameter for which a drug may be given.The general utilization of any cancer chemotherapy drug or biological will be covered for use that is not FDA approved (unlabeled) if used for anti-neoplastic conditions, and if the use is listed as acceptable in one of the Medicare-approved drug compendia and the use is not listed as "not indicated" or unfavorably evaluated in any of the compendia per CMS Internet-Only Manual (IOM), Pub 100-02, Chapter 15, 50.4.5 Off Label Use of Anti-Cancer Drugs and Biologicals.Although NCCN Category 2B is not included in the IOM, NCCN 2B indications are supported by evidence and require a consensus of the NCCN expert panel. For this reason, CGS Administrators considers any off label/drug or biological with a NCCN Category 2B indication to meet the benefit category requirements.CGS Administrators may also identify off-label uses for Anti-Cancer Drugs and Biologicals as part of anti-cancer chemotherapeutic regimen that are not listed as supported/recommended in medically accepted compendia (NCCN, Micromedex Drug DEX, Lexi-Drugs, AHFS or Clinical Pharmacology). Coverage will be determined for off-label use if supported by clinical research under the conditions identified in CMS Internet-Only Manual, Pub 100-02, Chapter 15, Section 50.4.5 Off-Label Use of Anti-Cancer Drugs and Biologicals. For a review of medications under ths process, please submit full articles, not abstracts, for consideration. CGS will communicate our decisions for off-label uses for Anti-Cancer Drugs and Biologicals an article published on our website.
Article - Off-Label Use of Drugs and Biologicals for Anti-Cancer Chemotherapeutic Regimen (A58113)
Consistent with CMS Internet-Only Manual, Pub 100-02, Chapter 15, Section 50.4.5 D if a cancer chemotherapy drug /biologic use is identified as not indicated by the Centers for Medicare and Medicaid Services (CMS) or the FDA, or use is specifically identified as not indicated in one or more of the compendia listed in Pub 100-02, Chapter 15, Section 50.4.5 B, or if CGS determines that peer-reviewed medical literature does not support the off-label usage, the drug/biologic is not covered.List the appropriate J or Q to indicate the drug name. When a specific HCPCS code does not exist, list the appropriate NOC code J3490, J3590, or J9999 with the drug name, and dose in the remarks field of the claim Item 19 of the CMS-1500 form for claims billed to the Part B MAC.For Part A, claims with C9399 are suspended, and remarks should be placed on the claim in field locator 80 for the UB04 claim form or SV202-7 for 837I electronic claim.Facilities under the hospital OPPS may use code C9399, billed as one unit, if it does not have an assigned HCPCS or the assigned HCPCS is not yet effective.Note: Claims billed to the Part B MAC with C9399 will be rejected.Claims billed with a NOC drug code are suspended and the following should be provided on the claim in the following fields:
Article - Off-Label Use of Drugs and Biologicals for Anti-Cancer Chemotherapeutic Regimen (A58113)
Field locator 80 for paper claims /line SV202-7 for electronic claims for Part A.Box 19 for paper claims/loop 2400 or SV101-7 for Part B.Claims billed for Not Otherwise Classified (NOC) codes need to include the following information in the fields listed above:Name of the drugDose administered (mg, cc, etc.)Route of administration (IV, IM, SC, PO, etc.)NDC number if availableThe invoice price (for new drugs if the wholesale acquisition cost (WAC) is unavailable, or for compounded drugs).The JW modifier is required for wastage in single-dose vials; this modifier does not apply to multi-dose vials per CMS Internet-Only Manual, Pub 100-04, Chapter 17, Section 40 Discarded Drugs and Biologicals (https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/clm104c17.pdf).
Article - Billing and Coding: Implantable Continuous Glucose Monitors (I-CGM) (A58116)
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) Implantable Continuous Glucose Monitors (I-CGM). Please refer to the LCD for reasonable and necessary requirements.Coding GuidanceImplantationof an implantable continuous glucose monitor (I-CGM) that meets the appropriate criteria as mentioned in LCD Implantable Continuous Glucose Monitors (I-CGM) is reported for either the 90 day or 180 day implantable sensor.For 90 day implantable glucose sensor report:CPT code 0446T - Creation of subcutaneous pocket with insertion of implantable interstitial glucose sensor, including system activation and patient trainingRemovalof an I-CGM is reported with:CPT code 0447T - Removal of implantable interstitial glucose sensor from subcutaneous pocket via incisionRemoval with immediate subsequent replacementof an I-CGM is reported with:CPT code 0448T - Removal of implantable interstitial glucose sensor with creation of subcutaneous pocket at different anatomic site and insertion of new implantable sensor, including system activationNotice: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.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: MolDX: Testing of Multiple Genes (A58120)
CMS National Coverage PolicyTitle 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.Title XVIII of the Social Security Act, 1833(e) prohibits Medicare payment for any claim which lacks the necessary information to process the claim.Title 42 CFR 410.32 Diagnostic x-ray tests, diagnostic laboratory tests, and other diagnostic tests: ConditionsArticle Text
Article - Billing and Coding: MolDX: Testing of Multiple Genes (A58120)
A panel of genes is a distinct procedural service from a series of individual genes. All services billed to Medicare must be reasonable and necessary. As such, if a provider or supplier submits a claim for a panel, then the patients medical record must reflect that the panel was reasonable and necessary. Alternatively, if a provider or supplier bills for a number of individual genes, then the patients medical record must reflect that each individual gene is reasonable and necessary.Refer toBilling and Coding: MolDX: Molecular Diagnostic Tests (MDT) A57526for CPT/HCPCS Codes that are applicable to this article.For ease of reading the term gene when used in this document will be used to indicate a gene, region of a gene, and / or variant(s) of a gene.Genes can be assayed serially or in parallel. Genes assayed on the same date of service are considered to be assayed in parallel if the result of 1 assay does not affect the decision to complete the assay on another gene, and the 2 genes are being tested for the same indication. Genes assayed on the same date of service are considered to be assayed serially when there is a reflexive decision component where the results of the analysis of 1 or more genes determines whether the results of additional analyses are reasonable and necessary.If a laboratory assays 2 or more genes in a patient in parallel, then those 2 or more genes will be considered part of the same panel. A panel constitutes a single procedural service, so 1 HCPCS codes must be submitted for the panel. If the laboratory assays genes in serial, then the laboratory must submit claims for genes individually. The order by the treating clinician must reflect whether the treating clinician is ordering a panel or single genes, and additionally, the patients medical record must reflect that the service billed was reasonable and necessary.Two examples:Single Service Example:A clinician orders 5 specific genes associated with breast cancer. The laboratory analyzes the 5 genes for common mutations using polymerase chain reaction. All 5 PCR procedures are started prior to the results of any 1 PCR procedure being known. The results are signed off on simultaneously, and all 5 results are sent to a clinician.
Article - Billing and Coding: MolDX: Testing of Multiple Genes (A58120)
This would be considered a single procedural service, a single 5 gene panel, and it must be billed as such. This single panel must be reasonable and necessary to be billed to Medicare.Multiple Distinct Procedural Services Example:A clinician requests that genes associated with early onset colorectal cancer be analyzed in a patient. The clinician orders stepwise reflex testing where a negative or positive result in 1 gene determines whether additional analysis on other genes will be performed or what that will be.Each gene assayed represents 1 procedural service, so if more than 1 gene is analyzed, then multiple procedural services may be billed in some patients for whom reflex testing goes beyond the first gene. Each gene billed to Medicare must be individually reasonable and necessary. A clinicians order is not by itself sufficient to indicate that a test was reasonable and necessary. The record must reflect that the test is used in the management of the beneficiary's specific medical problem in accordance with CFR 410.32.Labs must register a test with the Diagnostics Exchange as it reflected on the order form and is run in the laboratory. If a gene / variant is tested as part of a panel, then the lab must register the panel and must submit the correct z-code and CPT code for the panel. If a lab has a panel but sometimes also analyzes individual genes from the panel, the lab must register both the panel and the individual genes that are analyzed.In general 2 or more codes describing a genetic test billed on the same beneficiary on the same date may constitute a panel, and if so the service must be billed as a single procedural service. We would generally expect that a provider or supplier would not bill for more than 2 distinct laboratory genetic testing procedural services on a single beneficiary on a single date of service. If providers or suppliers do bill for more than two distinct laboratory genetic testing procedural services on a single beneficiary on a single date of service, the provider or supplier must attest that each additional service billed is a distinct procedural service using the 59 modifier.The use of the 59 modifier will be considered an attestation that distinct procedural services are being performed rather than a panel. Providers and suppliers must use the 59 modifier in conjunction with other modifiers where appropriate. When providers and suppliers bill for multiple distinct procedural services, each service must be reasonable and necessary.
Article - Billing and Coding: MolDX: Testing of Multiple Genes (A58120)
Laboratories that are billing for many individual genes using the 59 modifier rather than panels may be subject to medical review as outliers.When 2 or more codes are submitted for the same beneficiary on the same date of service, the claims processing system will reject every code submitted after the first service. However, if a lab runs more than 1 distinct procedural service on a single date of service, then the lab must use the 59 modifier with each additional service billed as an attestation that it is a distinct procedural service.