evekhm/cms_iom_500 huggingface dataset:
Article - Coverage of Foot Care Services (A52918)
CMS National Coverage PolicyN/AArticle TextNoridian has noted, through Medical Review, billing of foot care services as non-covered when documentation supports the patient has complaints of associated foot pain. The purpose of this educational article is to clarify coverage of foot care services related to pain.The Medicare Benefit Policy Manual (MBPM) Chapter 15 section 290.C.1(http://www.cms.hhs.gov)states, "In certain circumstances, services ordinarily considered to be routine may be covered if they are performed as a necessary and integral part of otherwise covered services, such as diagnosis and treatment of ulcers, wounds, or infections." In this regard, foot care services associated with a patient's complaints of pain wouldnotbe considered routine in nature. Pain may indicate a problem, such as an ulcer or infection, which is necessary to evaluate. If pain is associated with the reason for the foot care, it is reasonable and necessary for the medical professional to assess and evaluate the pain, and subsequently treat both the pain and the cause of the pain if possible.For all other covered indications for foot care services, including presumption of coverage guidelines, as well as foot care excluded from Medicare coverage, refer to the MBPM Chapter 15 section 290.Source:Medicare Benefit Policy Manual (MBPM) Chapter 15 section 290Social Security Act (SSA) Title XVIII section 1862(a)(1)(A)
Article - Sipuleucel-T (Provenge®) - Coverage Criteria for Prostate Cancer – Clarification (A52926)
CMS National Coverage PolicyN/AArticle TextSipuleucel-T (Provenge) is an autologous cellular immunotherapy, FDA-approved for the treatment of asymptomatic or minimally symptomatic metastatic castrate resistant (hormone refractory) prostate cancer.The production of Sipuleucel-T involves collection of the patients own cells (leukapheresis), culture with a proprietary antigen complex, and re-infusion of the antigen-activated patient cells back to the donor. Provenge is administered as three intravenous infusions, generally two weeks apart. When infused back into the patient, usually three days after leukapheresis, the patient-specific medication (autologous cellular therapy) stimulates a positive immunogenic response against the prostate cancer.For coverage, patient records must document that the product is being used according to the NCD 110.22.If the documentation does not describe the criteria above, does not meet all the requirements of the NCD on sipuleucel-T,is inconsistent with the FDA label and/or is not received, the services will be denied. Off-label use of this treatment is not covered unless it meets the requirements for off-label use of chemotherapeutic drugs in the Internet Only Manual 100-02 (Benefit Policy), Chapter 15 (Covered Services), Section 50.4.5.Noridian may coversipuleucel-Tfor the above condition when all requirements are met including the following coding instructions. (NOTE: Noridian will not allow payment for any off-label use of this treatment):For dates of service on/after July 1, 2011, use the following HCPCS code: Q2043 Sipuleucel-T auto CD54+.For dates of service prior to July 1, 2011, use one of the following HCPCS code: J3490, J3590 or C9273 (being replaced by Q2043).
Article - Sipuleucel-T (Provenge®) - Coverage Criteria for Prostate Cancer – Clarification (A52926)
For dates of service prior to July 1, 2011, use one of the following HCPCS code: J3490, J3590 or C9273 (being replaced by Q2043).The payment of HCPCS Q2043 includes collection of patients cells, activation with PAP-CM-CSF, including leukapheresis and all other preparatory procedures associated withsipuleucel-T. The code Q2043 does not include theadministrationof the treatments. CPT code 96365, intravenous infusion for therapy, prophylaxis, or diagnosis (specify substance or drug); initial, up to one (1) hour will be allowed for the administration of Q2043.Medicare will allow a maximum of three (3) infusions per lifetime.Sources: Internet Only Manual (IOM) Medicare National Coverage Determinations (NCD) Manual, Publication 100-03, Chapter 1, Section 110.22, IOM Medicare Claims Processing Manual, Publication 100-04, Chapter 32, Section 280; Transmittal 133, Change Request (CR)7431 dated July 8, 2011; Transmittal 2254, CR 7431 dated July 8, 2011.
Article - Billing and Coding: Lymphedema Decongestive Treatment (A52959)
CMS National Coverage PolicyN/AArticle TextWe are providing clarification of coverage and documentation requirements for lymphedema decongestive treatment based on Noridian medical review findings. The two basic types of decongestive treatment are: Manual Lymphatic Drainage (MLD) which stimulates the movement of fluids in the tissues using gentle massage and; Comprehensive Decongestive Therapy (CDT) which is a combination of MLD, bandaging, skin care and exercises.Coverage RequirementsMedicare will reimburse for necessary components of decongestive treatment when the medical record supportsA diagnosis of lymphedema (not tissue edema due to other etiologies e.g., chronic venous insufficiency, congestive heart failure, acute infection).Recent changes in the patients conditionPrior unsuccessful therapies (e.g., elevation, bandaging, diuresis) reported to justify the need for skilled services.Services were provided by a qualified clinician (i.e., physician, non-physician practitioner (NPP), qualified therapist, or appropriately supervised therapist assistant).Services must be under accepted standards of medical practice and considered to be specific and effective treatment for the patients condition.Limitations
Article - Billing and Coding: Lymphedema Decongestive Treatment (A52959)
LimitationsThe goal of therapy is not to achieve maximum volume reduction but to ultimately transfer the responsibility for the care from the provider to the patient and/or caregiver, generally within a 1-3 week time period. There is only temporary benefit from the treatment unless the patient and/or caregiver are able to complete treatments at home on an ongoing basis. The end of treatment is not when the edema resolves or stabilizes but when the patient and/or caregiver are able to continue the treatments at home.Skilled Level of CareThe key issue is whether the skills of a therapist are needed, or whether the services can be carried out by the patient and/or caregiver after sufficient training. The medical record must clearly indicate the patients condition before, during, and after the therapy episode to support that the patient significantly benefitted from ongoing therapy services and that the progress was sustainable and of practical value when measured against the patients condition at the start of treatment. Documentation should indicate clear objective evidence of improvement generally within the first week or 10 days of therapy (e.g., changes in weight, extremity circumference).Maintenance Level of CareWhen it is reasonable to assume that ongoing services could reasonably be carried out by the patient and/or appropriately trained caregiver(s), then the services are considered to be at a maintenance level of care and no longer require the skills of a qualified clinician. It is the patient's responsibility to acquire caregiver assistance for carrying out the of the home maintenance program when necessary. Generally, it is anticipated that an efficient home maintenance program will be effective for a lifetime. However, in the rare instance, when additional treatment for the same condition is necessary, then the documentation must support reasonableness and medical necessity for the additional services. For additional information, see the Noridian article titled "Medical Necessity of Therapy Services".Coding Considerations
Article - Billing and Coding: Lymphedema Decongestive Treatment (A52959)
Medically necessary hands-on MLD is a covered Medicare service and is coded using CPT 97140 for manual therapy.There is no Medicare coverage for lymphedema compression bandage application as this is considered to be an unskilled service. This non-coverage extends to the application of high compression, multi-layered, sustained bandage systems (e.g., Profore, Dynaflex, Supress, coded with CPT 29581 or 29584.Minutes spent applying compression bandaging without patient/caregiver education should not be billed as skilled therapy services.However, Medicare will cover a brief period (e.g. three or fewer sessions if no new specific issues are identified), of patient/caregiver instruction in compression bandaging home management. Medical necessity for this education must be clearly documented and meet the code descriptor requirements for CPT 97535.Note that high compression bandage application used for treatment of wounds may be appropriately coded with CPT 29581 or 29584. However, these codes should not be billed for unskilled lymphedema compression bandage application. For additional information, see the Noridian article titled "High Compression Bandage System Clarification."Sources:Federal Register (FR), Volume 76, Number 228, Part III, Section C-5Internet Only Manual (IOM)Medicare National Coverage Determinations Manual,Publication 100-03, Chapter 1, Part 4, Sections 270.5, 280.1, 280.6IOMMedicare Benefit Policy Manual,Publication 100-02, Chapter 15, Sections 220-230IOM Medicare Claims Processing Manual, Publication 100-04, Chapter 5, Section 20(B)Current Procedural Terminology Coding ManualSocial Security Act (SSA), Title 18, Section 1862(a)(1)(A)
Article - Sterilization (A52960)
CMS National Coverage PolicyN/AArticle TextSterilization means any medical procedure, treatment or operation for the sole purpose of rendering an individual permanently incapable of reproducing and not related to the repair of a damaged/dysfunctional body part.Under the Medicare Program guidelines the coverage of sterilization is limited to necessary treatment of an illness or injury. An example of necessary treatment is the removal of a uterus or removal of diseased ovaries (bilateral oophorectomy) because of a tumor, or bilateral orchiectomy in the case of prostate cancer.Elective hysterectomy, tubal ligation and vasectomy in the absence of a disease for which sterilization is considered an effective treatment is not covered. In addition, no payment would be made for sterilization procedures if it is a preventive measure e.g., a physician believes pregnancy would cause overall endangerment to a woman's health, or as a measure to prevent the possible development of, or effect on a mental condition, should pregnancy occur. (Section 1862(a)(1)(A) of the Social Security Act and 42 CFR 411.15(k).Claims will be denied on postpay review and payment recouped if the pathological evidence of the necessity to perform any of these procedures to treat an illness or injury is absent and/or when the primary objective is to achieve sterilization.
Article - Billing and Coding: Biomarkers for Oncology (A52986)
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) L35396, Biomarkers for Oncology. 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.Test Panel DefinitionA predetermined set of medical tests composed of individual laboratory tests related by medical condition, specimen type, frequency ordered, methodology or types of components to aid in the diagnosis/treatment of diseases. The performance of multiple molecular tests regardless of whether the requisition lists the tests as a panel or individually and completed on a single sample is considered to be a Panel of tests and should be billed under a single CPT code to prevent stacking of codes.Consistent with the Limitations outlined in LCD, Biomarkers for Oncology, the following tests will all be covered once per lifetime per beneficiary:CPT code 81345 - Brain Molecular BiomarkersCPT code 81437  Hereditary neuroendocrine tumor disordersCPT code 81438  Hereditary neuroendocrine tumor disorders; duplication/deletion analysisThyraMIR (CPT 0018U), Afirma (CPT 81546), ThyGeNEXT (CPT 0245U), RosettaGX Reveal (CPT 81479) and ThyroSeq tests (CPT 0026U) (CPT 0287U)Should the unlikely situation of a second, unrelated thyroid nodule with indeterminate pathology occur, coverage may be considered upon appeal with supporting documentationCPT code 81540 TUO CTID (Cancer TYPE ID)
Article - Billing and Coding: Biomarkers for Oncology (A52986)
CPT code 81540 TUO CTID (Cancer TYPE ID)Review of General Molecular Pathology Coding ChangesIn 2012, CPT created new Tier 1 (gene specific) and Tier 2 molecular pathology codes.The Tier 1 molecular pathology codes are applicable to specific biomarkers. However, Tier 2 molecular pathology codes are used to identify groups of biomarkers that require the similar levels of technical and interpretive resources required to complete the testing. Tier 2 codes represent rare disease and molecular pathology procedures that are performed in lower volumes than Tier 1 procedures. These codes should rarely, if ever, be used unless instructed by other coding and billing articles.Because there are multiple biomarkers represented by each of the Tier 2 codes, when billing for these codes, the specific biomarker must be reported in the claim narrative/remarks.Reporting of the specific biomarker, WITHOUT providing the full descriptor will suffice. However, in some cases, such as the example provided below, it may be necessary to provide abbreviated information to identify the specific service provided.CPT code 81479 - Unlisted molecular pathology should be used to report a specific biomarker that is not represented by a Tier 1 code and is not accurately described by one of the Tier 2 codes.A description of the testing performed must be included in the narrative/remarks when using this code.Billing Claims with Multiple BiomarkersPlease refer to the Local Coverage Article A58917, Billing and Coding: Molecular Pathology and Genetic Testing for information.Selected Oncology Tests1. UroVysion Bladder Kit servicesThe following information should be reported on the claim:CPT code 88120 or 88121 as appropriate.'UroVysion should be placed in the comment/narrative field for the following claim field/types:Loop 2400, NTE02, or SV101-7 for the 5010A1 837PSubmit 'UroVysion' on an attachment to the claim form when submitting a paper claim.
Article - Billing and Coding: Biomarkers for Oncology (A52986)
Loop 2400, NTE02, or SV101-7 for the 5010A1 837PSubmit 'UroVysion' on an attachment to the claim form when submitting a paper claim.Laboratories reporting only the technical component for a UroVysion service should append the appropriate CPT code 88120 or 88121 with the TC HCPCS modifier.Note:Physicians may not submit claims for a CPT code 88120 and 88121 professional component when the interpretive information is provided by a lab technician or scientist. Please refer to CMS IOM 100-04, Chapter 23, Section 20.9 for National Correct Coding Initiative (NCCI) information.2. Rosetta Cancer Origin Test when a conventional surgical pathology/imaging work-up is unable to identify a primary neoplastic site.The following information should be reported on the claim:CPT code 81479 Unlisted molecular pathology procedureEnter 'Initial Work-Up  in the comment/narrative field for the following claim field/types:Loop 2400, NTE02, or SV101-7 for the 5010A1 837PSubmit 'Initial Work-Up  on an attachment to the claim form when submitting a paper claim.Note:The full, continued version of this Initial Work-Up comment DOES NOT have to be a standardized response, but simply a brief summary (totaling less than 80 characters) to ensure that a preliminary surgical pathology evaluation has been performed prior to the ordering of the biomarker. An example might read as follows: Initial Work-Up shows medium probability of breast CA via IHC.3. VeriStrat assay (CPT code 81538)Enter 'Initial Work-Up  in the comment/narrative field for the following claim field/types:Loop 2400, NTE02, or SV101-7 for the 5010A1 837PSubmit 'Initial Work-Up  on an attachment to the claim form when submitting a paper claim.Note:The full, continued version of this Initial Work-Up comment DOES NOT have to be a standardized response, but simply a brief summary (totaling less than 80 characters) to ensure that a preliminary predictive testing evaluation has been performed prior to the ordering of the VeriStrat assay. Two examples might read as follows:
Article - Billing and Coding: Biomarkers for Oncology (A52986)
Initial Work-Up shows EGFR wild-typeInitial Work-Up without ability to test EGFR4. OVA1 and ROMA proteomic assaysOVA1 has been cleared by the FDA for women who meet all of the following criteria:Are over 18 years of ageHave an ovarian massHave surgery plannedEnter The patient meets all 3 FDA OVA1 criteria in the comment/narrative field for the following claim field/types:Loop 2400, NTE02, or SV101-7 for the 5010A1 837PSubmit The patient meets all 3 FDA OVA1 criteria on an attachment to the claim form when submitting a paper claim.For OVA1, use CPT code 81503.5. PROGENSA PCA3 test (regarding prostate cancer):Should be billed with CPT code 81313Claim must include PCA3 and contain one of the corresponding ICD-10-CM codes listed in the ICD-10-CM Codes that Support Medical Necessity Group 9 below.6. MyPRS Genetic Expression Profile TestingShould be billed with CPT code 81479MyPRS should be entered in box 19, or electronic equivalent, on the claimClaim must include one of the corresponding ICD-10-CM codes listed in the ICD-10-CM Codes that Support Medical Necessity Group 24 below.7. ThyraMIR, ThyGeNEXT, Afirma, RosettaGX Reveal or ThyroSeq Thyroid
Article - Billing and Coding: Biomarkers for Oncology (A52986)
7. ThyraMIR, ThyGeNEXT, Afirma, RosettaGX Reveal or ThyroSeq ThyroidIntended use of ThyraMIRThyraMIR may be used for cytologically indeterminate thyroid nodules categorized as either AUS/FLUS or FN/SFN within the Bethesda classification scheme for FNA cytology. It is performed following a negative ThyGeNEXT result for all mutations or when mutations detected are not fully indicative of malignancy (i.e., ThyGeNEXT results which favor a benign nodule, but cancer could still be present). ThyGeNEXT, and ThyraMIR combination testing, along with other clinical information, may be used by physicians to help determine the need for surgery or clinical follow up when patients are diagnosed with indeterminate thyroid nodules.The original FNA sample collected for molecular testing with ThyGeNEXT is also used to perform the ThyraMIR test; a separate sample is not required.To report a ThyraMIR service, please submit the following claim information:CPT code0018UEnter ThyraMIR in the comment/narrative field for the following claim field/types:Part A claims:Loop SV202-7 for 837I electronic claimBlock 80 for the UB04 claim formPart B claims:Loop 2400 or SV101-7 for the 5010A1 837PBox 19 for the paper claimTo report ThyGeNEXT tests, please submit the following claim information:CPT code 0245UEnter ThyGeNEXT in the comment/narrative fieldPart A claims:Loop SV202-7 for 837I electronic claimBlock 80 for the UB04 claim formPart B claims:Loop 2400 or SV101-7 for the 5010A1 837PBox 19 for the paper claimTo report Afirma tests, please submit the following claim information:CPT code 81546Enter Afirma in the comment/narrative fieldPart A claims:Loop SV202-7 for 837I electronic claimBlock 80 for the UB04 claim formPart B claims:Loop 2400 or SV101-7 for the 5010A1 837PBox 19 for the paper claimTo report RosettaGX Reveal Thyroid tests, please submit the following claim information:
Article - Billing and Coding: Biomarkers for Oncology (A52986)
Part B claims:Loop 2400 or SV101-7 for the 5010A1 837PBox 19 for the paper claimTo report RosettaGX Reveal Thyroid tests, please submit the following claim information:CPT code 81479Enter Rosetta GX Reveal Thyroid in the comment/narrative fieldPart A claims:Loop SV202-7 for 837I electronic claimBlock 80 for the UB04 claim formPart B claims:Loop 2400 or SV101-7 for the 5010A1 837PBox 19 for the paper claimTo report ThyroSeq Thyroid tests, please submit the following claim information:CPT code 0026U or 0287UEnter ThyroSeq test in the comment/narrative fieldPart A claims:Loop SV202-7 for 837I electronic claimBlock 80 for the UB04 claim formPart B claims:Loop 2400 or SV101-7 for the 5010A1 837PBox 19 for the paper claimPlease refer to LCD L35396-Biomarkers for Oncology for coverage detailsfor ThyraMIR, Afirma, ThyGeNEXT, RosettaGX Reveal and ThyroSeq Thyroid tests.8. Oncomine DX TestTo report Oncomine DX Test service, please submit the following claim information:CPT code 0022U - Tgt gen seq dna&rna 1-23 geneThe identifier of Oncomine DX must be in the comment/narrative field as follows:Part A claims:Loop SV202-7 for 837I electronic claimBlock 80 for the UB04 claim formPart B claims:Loop 2400 or SV101-7 for the 5010A1 837PBox 19 for the paper claim9. ColonSeq testShould be billed with CPT code 81445Enter ColonSeq in the comment/narrative field for the following claim field/types.Part A claims:Loop SV202-7 for 837I electronic claimBlock 80 for the UB04 claim formPart B claims:Loop 2400 or SV101-7 for the 5010A1 837PBox 19 for the paper claimThe claim must contain one of the corresponding ICD-10-CM codes listed in the ICD-10-CM Codes that Support Medical Necessity Group 1 below.10. LungSeq test
Article - Billing and Coding: Biomarkers for Oncology (A52986)
The claim must contain one of the corresponding ICD-10-CM codes listed in the ICD-10-CM Codes that Support Medical Necessity Group 1 below.10. LungSeq testShould be billed with CPT code 81445Enter LungSeq in the comment/narrative field for the following claim field/types.Part A claims:Loop SV202-7 for 837I electronic claimBlock 80 for the UB04 claim formPart B claims:Loop 2400 or SV101-7 for the 5010A1 837PBox 19 for the paper claimThe claim must contain one of the corresponding ICD-10-CM codes listed in the ICD-10-CM Codes that Support Medical Necessity Group 2 below.11. Colvera test (BCAT1/IKZF1 promoter hypermethylation)Intended use of ColveraColvera is a diagnostic laboratory test used to detect the presence of colorectal cancer circulating tumor DNA. Colvera is intended to be used to detect residual disease following surgery or treatment for primary or recurrent colorectal cancer, and to surveil for recurrence of a previously treated colorectal cancer. Testing is covered when all the following are met:The patient has been previously diagnosed with an AJCC stage I, II, III or IV colorectal cancer, or a recurrence of colorectal cancer, within the previous five years.The patient has no evidence of neoplastic disease at the time the test is ordered. (If the patient is known to be with cancer or presumed to have cancer, this testing is not indicated).The patient is able to tolerate surgery or adjuvant chemotherapy for residual or recurrent colorectal cancer.Testing may be ordered no more than four times per 12-month period.To report a Colvera service, please submit the following claim information:CPT code 0229UEnter Colvera in the comment/narrative field for the following claim/field types:Part A claims:Loop SV202-7 for 837I electronic claimBlock 80 for the UB04 claim formPart B claims:Loop 2400 or SV101-7 for the 5010A1 837PBox 19 for the paper claimThe claim must contain one of the corresponding ICD-10-CM codes listed in the ICD-10-CM Codes that Support Medical Necessity Group 1 below.Documentation Requirements