evekhm/cms_iom_500 huggingface dataset:
Article - Billing and Coding: MolDX: Mitochondrial Nuclear Gene Tests (A55290)
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.Article TextMitochondrial disorders are a group of conditions caused by dysfunction in the mitochondrial respiratory chain. Current genetic testing methods are unable to detect mutations in all individuals with suspected mitochondrial disease, and there is no proven effective treatment for persons with a known mitochondrial disease. Therefore, the MolDX Team has determined mitochondrial nuclear gene tests do not support the required clinical utility for the established Medicare benefit category and are statutorily excluded tests.To receive a mitochondrial nuclear panel service denial, please submit the following claim information:CPT code 81479- Unlisted molecular pathology procedureAn Advance Beneficiary Notice (ABN) is not required for statutorily excluded servicesFor a voluntary issued ABN, append with GX HCPCS modifierTo indicate a statutorily excluded service, append with a GY HCPCS modifierEnter DEX Z-Code identifier adjacent to the CPT code in the comment/narrative field for the following Part B claim field/typesLoop 2400 or SV101-7 for the 5010A1 837PItem 19 for paper claimEnter DEX Z-Code identifier adjacent to the CPT code in the comment/narrative field for the following Part A claim field/types:Line SV202-7 for 837I electronic claimBlock 80 for the UB04 claim form
Article - Billing and Coding: MolDX: Mitochondrial Nuclear Gene Tests (A55291)
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.Article TextMitochondrial disorders are a group of conditions caused by dysfunction in the mitochondrial respiratory chain. Current genetic testing methods are unable to detect mutations in all individuals with suspected mitochondrial disease, and there is no proven effective treatment for persons with a known mitochondrial disease. Therefore, the MolDX Team has determined mitochondrial nuclear gene tests do not support the required clinical utility for the established Medicare benefit category and are statutorily excluded tests.To receive a mitochondrial nuclear panel service denial, please submit the following claim information:CPT code 81479- Unlisted molecular pathology procedureAn Advance Beneficiary Notice (ABN) is not required for statutorily excluded servicesFor a voluntary issued ABN, append with GX HCPCS modifierTo indicate a statutorily excluded service, append with a GY HCPCS modifierEnter DEX Z-Code identifier adjacent to the CPT code in the comment/narrative field for the following Part B claim field/typesLoop 2400 or SV101-7 for the 5010A1 837PItem 19 for paper claimEnter DEX Z-Code identifier adjacent to the CPT code in the comment/narrative field for the following Part A claim field/types:Line SV202-7 for 837I electronic claimBlock 80 for the UB04 claim for
Article - Billing and Coding: MolDX: myPap™ (A55292)
CMS National Coverage PolicyTitle XVIII of the Social Security Act, 1862(a)(1)(A) statutory exclusion covers diagnostic testing "except for items and services that are not reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member".Article TextThe myPAP DNA test, developed to complement a Papanicolaou (Pap) test, confirms a Pap specimen belongs to the patient evaluated for treatment. The MolDX Team agrees the healthcare community should define and follow strict procedures regarding patient and patient specimen identification and handling. Tests performed to measure the quality or control of a process and do not provide information to diagnose or treat a patient illness or injury do not meet the criteria for a Medicare benefit. Therefore, the myPAP test is a statutorily excluded test. Although an Advance Beneficiary Notice (ABN) is not required for a statutory exclusion, providers supplying this test (directly or through a purchased service) should ensure patients understand the test is not a covered benefit.Providers must register for a DEX Z-Code identifier prior to claim submission. To access the MolDX registry, go to the DEXDiagnostics Exchange located at: https://app.dexzcodes.com/login. Once an ID has been obtained, please submit the following claim information to receive a myPAP Medicare service denial:CPTcode 84999  unlisted chemistry procedureAn Advance Beneficiary Notice (ABN) is not required for statutorily excluded serviceFor a voluntary issued ABN, append with GX modifierTo indicate a statutorily excluded service, append with a GY modifierEnter 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 837PItem 19 for paper claimEnter DEX Z-Code identifier adjacent to the CPT code in the comment/narrative field for the following Part A claim field/types:Line SV202-7 for 837I electronic claimBlock 80 for the UB04 claim formIf you believe your practice has submitted claims and received reimbursement in error, you may take the following corrective actions:
Article - Billing and Coding: MolDX: myPap™ (A55292)
If you believe your practice has submitted claims and received reimbursement in error, you may take the following corrective actions:Complete a Self-AuditIdentify incorrect submissionsContain further claim submission errorsConsider Self-Disclosure ProtocolSelf-disclosure guidelines
Article - Billing and Coding: MolDX: myPap™ (A55293)
CMS National Coverage PolicyTitle XVIII of the Social Security Act, 1862(a)(1)(A) statutory exclusion covers diagnostic testing "except for items and services that are not reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member".Article TextThe myPAP DNA test, developed to complement a Papanicolaou (Pap) test, confirms a Pap specimen belongs to the patient evaluated for treatment. The MolDX Team agrees the healthcare community should define and follow strict procedures regarding patient and patient specimen identification and handling. Tests performed to measure the quality or control of a process and do not provide information to diagnose or treat a patient illness or injury do not meet the criteria for a Medicare benefit. Therefore, the myPAP test is a statutorily excluded test. Although an Advance Beneficiary Notice (ABN) is not required for a statutory exclusion, providers supplying this test (directly or through a purchased service) should ensure patients understand the test is not a covered benefit.Providers must register for a DEX Z-Code identifier prior to claim submission. To access the MolDX registry, go to the DEXDiagnostics Exchange located at: https://app.dexzcodes.com/login. Once an ID has been obtained, please submit the following claim information to receive a myPAP Medicare service denial:CPTcode 84999  unlisted chemistry procedureAn Advance Beneficiary Notice (ABN) is not required for statutorily excluded serviceFor a voluntary issued ABN, append with GX modifierTo indicate a statutorily excluded service, append with a GY modifierEnter 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 837PItem 19 for paper claimEnter DEX Z-Code identifier adjacent to the CPT code in the comment/narrative field for the following Part A claim field/types:Line SV202-7 for 837I electronic claimBlock 80 for the UB04 claim formIf you believe your practice has submitted claims and received reimbursement in error, you may take the following corrective actions:
Article - Billing and Coding: MolDX: myPap™ (A55293)
If you believe your practice has submitted claims and received reimbursement in error, you may take the following corrective actions:Complete a Self-AuditIdentify incorrect submissionsContain further claim submission errorsConsider Self-Disclosure ProtocolSelf-disclosure guidelines
Article - Billing and Coding: MolDX: Germline testing for use of PARP inhibitors (A55294)
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 L38972. 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 L38972, 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 L38972 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: MolDX: Germline testing for use of PARP inhibitors (A55295)
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 L38974. 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 L38974, 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 L38974 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: Instructions for Lemtrada® (alemtuzumab) When Used in the Treatment of Relapsing Multiple Sclerosis (A55310)
CMS National Coverage PolicyN/AArticle TextLemtradais indicated in the treatment of patients with relapsing forms of multiple sclerosis. The dosage of Lemtradawhen used for this indication is 12mg/day infused for 5 consecutive days, then 12mg/day infused for 3 consecutive days at one interval, one year from the first course of treatment.To submit a claim for LemtradainPart B of A (hospital outpatient) on a UB-04 claim form, the following information must appear on the form:Diagnosis-(Box 66)ICD-10 G35 Multiple Sclerosis (for claims with date of service (DOS) from 10/01/2015 forward)HCPCS drug code-(Field 44)J0202 Injection, alemtuzumab 1mg (DOS 01/01/2016 forward)Narrative (Remarks) in (Field 80) (or electronic equivalent)National Drug Code (NDC)- 58468-0200-1 or 58468-0200-01 Single use vial 12mg/1.2 ml (10mg/ml)Name of Drug (trade and generic)Dose of drug administeredRoute of administrationTo submit a claim for LemtradainPart B on a CMS-1500 claim form, the following information must appear on the form:Diagnosis-(Box 21)ICD-10 G35 Multiple Sclerosis (for claims with DOS from 10/01/2015 forward)HCPCS drug code- (Box 24D)J0202 Injection, alemtuzumab 1mg (DOS 01/01/2016 forward)Narrative- (Box 19) (or electronic equivalent)NDC- 58468-0200-1 or 58468-0200-01 Single use vial 12mg/1.2 ml (10mg/ml)Name of Drug (trade and generic)Dose of drug administeredRoute of administrationNote:This drug is supplied in a single use vial that contains 12mg of alemtuzumab. PerFood and Drug Administration (FDA) labeling, the dose of this drug is 12mg per day, therefore claims reflecting administered dosages other than 12mg perDOS or claims reporting wastage or productNDC numbers other than those listed above will be rejected.
Article - Billing and Coding: Proton Beam Therapy (A55315)
CMS National Coverage PolicyN/AArticle TextThis article gives guidance for billing, coding, and other guidelines in relation to local coverage policy L36658-Proton Beam Therapy.Documentation RequirementsAll documentation must be maintained in the patients medical record and 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 record must include the physician or non-physician practitioner responsible for and providing the care of the patient.The submitted medical record should support the use of the selected diagnosis code(s). The submitted CPT/HCPCS code should describe the service performed.Each claim must be submitted with diagnosis codes that reflect the condition of the patient, and indicate the reason(s) for which the service was performed. Claims submitted without diagnosis codes will be returned.Documentation in the patient medical record must support the reasonable and necessary requirements as outlined under the Coverage Indication, Limitations, and/or Medical Necessity section of this LCD.Documentation must include the planned course of therapy, type and delivery of treatment, level of clinical management involved and ongoing documentation of any changes in the course of treatment, and DHV as noted in the covered indications section.Coding1. The proton delivery codes are technical component only codes and can only be billed by the facility delivering the treatment.2. Selection of the correct code is based on the complexity and compensation of the treatment.Simple- Proton treatment delivery to a single treatment area utilizing a single nontangential/oblique port, custom block with compensation (CPT 77522) and withoutcompensation (CPT 77520).Intermediate- Proton treatment delivery to one or more treatment areas utilizing two or more ports or one or more tangential/oblique ports with custom blocks and compensators (CPT 77523).Complex- Proton treatment delivery to one or more treatment areas utilizing two or more ports per treatment area with matching or patching fields and/or multiple isocenters, with custom blocks and compensators (CPT 77524).3. The physician work is billed under treatment planning and treatment management codes.
Article - Billing and Coding: Proton Beam Therapy (A55315)
3. The physician work is billed under treatment planning and treatment management codes.4. CMS Pub 100-04Medicare Claims Processing Manual, Chapter 32  Billing Requirements for Special Services, Section 69.6  Requirements for Billing Routine Costs of Clinical Trials.Routine Costs Submitted by Practitioners/Suppliers:Services furnished to Medicare beneficiaries, who are control group volunteers participating in qualifying clinical trials, are to be coded/billed in the following manner:Effective for claims with dates of service on or after January 1, 2014 it is mandatory to report a clinical trial number on claims for items/services provided in clinical trials/studies/registries, or under CED. Provides report the 8-digit number on the following claims locators:CMS-1500 paper form-place in Field 19 (preceded by CT);or837 PLoop 2300, REF02, REF01-P4 (do not use CT on the electronic claim).In addition to the clinical trial number, claims should include:Diagnosis code Z00.6 (in either the primary/secondary positions)HCPCS modifier Q0 or Q1 as appropriate5. The associated IDE/NCT numbers MUST be included on each claim. The below applies to both Institutional and Professional claims:The 7-digit alpha numeric IDE number should be placed in REF02 (REF01=LX)8 Digit NCT Registry Number must be on the claim as follows:For institutional claims that are submitted on the electronic claim 837I, the 8-digit number should be placed in Loop 2300 REF02 (REF01=P4) when a clinical trial claim includes:Condition code 30; ICD-9 code of V70.7/ICD-10 code Z00.6 (in either the primary or secondary positions) andModifier Q0 and/or Q1, as appropriate (outpatient claims only).For professional claims:
Article - Billing and Coding: Proton Beam Therapy (A55315)
For professional claims:For electronic claims the 8-digit clinical trial number is listed as; the electronic equivalent 837P in Loop 2300 REF02(REF01=P4) (do not use CT on the electronic claim, e.g., 12345678)The 8-digit clinical trial number preceded by the 2 alpha characters of CT (use CT only on paper claims) must be placed in Field 19 of the paper claim Form CMS-1500 (e.g., CT12345678) or when a clinical trial claim includes:ICD-9 code of V70.7/ICD-10 code Z00.6 (in either the primary or secondary positions) and Modifier Q0 and/or Q1, as appropriate (outpatient claims only)Routine Costs Submitted by Institutional Providers:Services furnished to Medicare beneficiaries, who are control group volunteers participating in qualifying diagnostic clinical trials, are to be coded/billed in the following manner:All Institutional Clinical Trial ClaimsEffective for claims with dates of service on or after January 1, 2014, it is mandatory to report a clinical trial number on claims for items/services provided in clinical trials/studies/registries, or under CED. Institutional claims submitted without a clinical trial number shall be returned to providers.NOTE: The Q1 modifier is line item specific and must be used to identify items and services that constitute medically necessary routine patient care or treatment of complications arising from a Medicare beneficiarys participation in a Medicare covered clinical trial. Items and services that are provided solely to satisfy data collection and analysis needs and that are not used in the clinical management of the patient are not covered and may not be billed using the Q1 modifier. Items and services that are not covered by Medicare by virtue of a statutory exclusion or lack of a benefit category also may not be billed using the Q1 modifier. When billed in conjunction with the Z00.6 diagnosis code, the Q1 modifier will serve as the providers attestation that the service meets the Medicare coverage criteria (i.e., was furnished to a beneficiary who is participating in a Medicare qualifying clinical trial and represents routine patient care, including complications associated with qualifying trial participation).Inpatient Clinical Trial Claims
Article - Billing and Coding: Proton Beam Therapy (A55315)
Inpatient Clinical Trial ClaimsInstitutional providers billing clinical trial service(s) must report diagnosis code Z00.6 in either the primary or secondary position and a condition code 30 regardless of whether all services are related to the clinical trial or not.NOTE: HCPCS codes are not reported on inpatient claims. Therefore, the HCPCS modifier requirements (i.e., Q0/Q1) as outlined in the outpatient clinical trial section immediately below, are not applicable to inpatient clinical trial claims.Outpatient Clinical Trial ClaimsOn all outpatient clinical trial claims, providers need to do the following:Report condition code 30,Report Diagnosis code Z00.6, if ICD-10-CM is applicable, in the primary or secondary position: andIdentify all lines that contain an investigational item/service with a HCPCS modifier of: Q0 for dates of service on or after 1/1/08Identify all lines that contain a routine service with a HCPCS modifier of:Q1 for dates of service on or after 1/1/08.If the patient cannot clearly meet the criteria for coverage but desires Proton beam radiotherapy based on a marketed theoretical advantage, an ABN should be signed and the claim should be billed with the GA modifier appended to the treatment delivery code. The patient is then liable for payment of the procedure.