evekhm/cms_iom_500 huggingface dataset:
Article - Billing and Coding: Erythropoiesis Stimulating Agents (A58982)
A pre-initiation Hb level < 10 g/dL with ongoing individualized dosing to achieve and maintain Hblevels between 10-12 g/dL.Documentation of dose reduction should be evident as the Hb level approaches 12 (11 in the case of epoetin beta or 10 with darbepoetin alfa) or when the Hb level rises by more than 1 g/dL within a 2-week period. During therapy, hematological parameters should be monitored at least weekly until the Hb is stable and sufficient to minimize the need for transfusion. Thereafter, monitor Hb at least monthly.For patients whose Hbdoes not attain a level within the range of 10 to 12 g/dL despite appropriate dose titrations over a 12-week period, documentation should not demonstrate further increases in dose amounts but rather continuation of the lowest dose that will avoid the need for recurrent RBC transfusions. When recurrent RBC transfusions become necessary within the setting of ESA use exceeding 12 weeks, the ESA therapy should be stopped due to lack of responsiveness.Increases in dose should not be made more frequently than once a month.Evaluation and treatment of other causes of anemia (and documentation thereof) must occur pre-ESA initiation and at any time thereafter as needed for lack of responsiveness.Prior to ESA therapy, the patients iron stores, including transferrin saturation (serum iron divided by iron binding capacity) and serum ferritin, must be evaluated. Transferrin saturation should be at least 20%, and ferritin should be at least 100 ng/mL. Iron stores must also be checked prior to dosage increases.Due to the frequency of concomitant iron deficiency in these patients, even without dosage adjustments, iron storage must be checked at least every 3 months during ongoing ESA therapy.If the initial dose of an ESA was administered in another setting (i.e. hospital, in a state outside our jurisdiction, or in another facility); subsequent office-administered ESAs must still meet all the above-mentioned requirements. This may require review of outside medical records and confirmation that needed pre-treatment lab results and evaluation were completed appropriately.Anemia Due to Antineoplastic Chemotherapy
Article - Billing and Coding: Erythropoiesis Stimulating Agents (A58982)
Anemia Due to Antineoplastic ChemotherapyThis policy does not replace or supersede existing Medicare applicable National Coverage Determination (NCD) 110.21.Epoetin beta is NOT indicated or covered for treatment of anemia due to cancer chemotherapy.Required Documentation Elements:The ESA utilized:Darbepoetin alfa (J0881) or epoetin alfa (J0885) or epoetin alfa-epbx biosimilar (Q5106)
Article - Billing and Coding: Erythropoiesis Stimulating Agents (A58982)
Use of the ESA forsymptomaticanemia due to antineoplastic chemotherapyA diagnosis of a non-myeloid malignancy (solid tumor, multiple myeloma, lymphoma, or lymphocytic leukemia)For HCPCS codes J0881, J0885 or Q5106: ICD-10-CM code D64.81 or D61.810 AND 1 of the malignancy codes listed in ICD-10 Group 3 MUST be billed together. The EA modifier is also required. A JA or JB modifier is required.Inclusion of any other ICD-10 diagnoses on the claim which are non-covered with an EC modifier per NCD 110.21, except for ICD-10 codes strictly indicating a relationship to adverse effect of antineoplastic drugs or chemotherapy, will preclude payment for the ESA.DOSING:Fordarbepoetin alfa therapy in anemia due to antineoplastic chemotherapy:2.25 mcg/kg every week SQ or 500 mcg every 3 weeks until completion of the chemotherapy course.If Hb increases more than 1 g/dL in any 2-week period or if a Hblevel is reached that will avoid RBC transfusion, then the dose of darbepoetin alfa should be decreased by 40%.During treatment, if Hbincreases by less than 1 g/dLandremains below 10 g/dL after 4 weeks of therapy, the dose of darbepoetin alfa may be increased once by 25%.If there is no response as measured by Hblevels or if RBC transfusions are still required after 8 weeks of therapy, darbepoetin therapy should be stopped. Darbepoetin therapy must cease following completion of a chemotherapy course.Forepoetin alfa/epoetin alfa-epbx biosimilar in anemia due to antineoplastic chemotherapy:Initial dosing:150 Units/kg SC TIW or 40,000 units SC weeklyReduce dose by 25% when Hbreaches a level needed to avoid transfusion or increases > 1 g/dL in any 2-week period.Increase dose by 25%, if there is no reduction in transfusion requirements or the Hblevel does not rise>1 g/dL after 4 weeks of therapy.
Article - Billing and Coding: Erythropoiesis Stimulating Agents (A58982)
Increase dose by 25%, if there is no reduction in transfusion requirements or the Hblevel does not rise>1 g/dL after 4 weeks of therapy.If after 8 weeks of therapy there is no response as measured by Hblevels or if transfusions are still required, epoetin alfa should be discontinued. Epoetin alfa therapy must cease following completion of a chemotherapy course.
Article - Billing and Coding: Erythropoiesis Stimulating Agents (A58982)
ESA treatment duration for each course of chemotherapy includes the 8 weeks following the final dose of myelosuppressive chemotherapy in a chemotherapy regimen.Any ESA administered for anemia in association with cancer chemotherapy will only be covered if the Hb level immediately prior to initiation or maintenance of the ESA treatment is less than 10 g/dL (or the HCT < 30%).An ESA should only be started if there is a minimum of 2 additional months of planned chemotherapy.ESAs should not be used in a patient with cancer receiving myelosuppressive chemotherapy when the anticipated outcome for the cancer is cure.Hb levels should be monitored on a weekly basis in patients receiving ESA therapy until Hb becomes stable. ESA doses should be titrated as low as possible for each patient to achieve and maintain the lowest Hblevel sufficient to avoid the need for blood transfusion.Although no specific serum EPO level can be stipulated above which patients would be unlikely to respond to ESA therapy, treatment of patients with grossly elevated serum EPO levels (e.g., > 200 mUnits/mL) is not recommended.Evaluation and treatment of other causes of anemia must occur pre-ESA initiation and at any time thereafter as needed for lack of responsiveness.Prior to ESA therapy, the patients iron stores, including transferrin saturation (serum iron divided by iron binding capacity) and serum ferritin, must be evaluated. Transferrin saturation should be at least 20%, and ferritin should be at least 100 ng/mL. Iron stores must also be checked prior to dosage increases. Even without dosage adjustments, iron storage must be checked at least every 3 months during ongoing ESA therapy.If the initial dose of an ESA was administered in another setting (i.e., hospital, in a state outside our jurisdiction, or in another facility); subsequent office-administered ESAs must still meet all the above-mentioned requirements. This may require review of outside medical records and confirmation that needed pre-treatment lab results and evaluation were completed appropriately.Anemia in Zidovudine Treated HIV InfectionDarbepoetin alfa and epoetin beta are NOT indicated for this condition.Forepoetin alfa/epoetin alfa-epbx biosimilar in anemia related to Zidovudine treated HIV:
Article - Billing and Coding: Erythropoiesis Stimulating Agents (A58982)
Darbepoetin alfa and epoetin beta are NOT indicated for this condition.Forepoetin alfa/epoetin alfa-epbx biosimilar in anemia related to Zidovudine treated HIV:Epoetin alfa is not indicated for the treatment of anemia in HIV-infected patients due to other factors such as iron or folate deficiencies, hemolysis, or gastrointestinal bleeding, which should be managed appropriately.Epoetin alfa therapy for anemia related to Zidovudine therapy for HIV must not target a Hb> 12 g/dL.Required Documentation Elements:Use of the ESA forsymptomaticanemia due to AZT therapyZidovudine therapy at a dose<4200 mg/weekAn endogenous baseline pre-transfusion serum EPO level<500 mUnits/mLA dose titrated to the individual need to achieve and maintain the lowest Hb level needed to avoid RBC transfusions.The ESA Utilized:Epoetin alfa (J0885) or epoetin alfa-epbx biosimilar (Q5106)
Article - Billing and Coding: Erythropoiesis Stimulating Agents (A58982)
For patients with symptomatic anemia due to adverse impact of AZT, a diagnosis of D61.1 and either B20 or B97.35 must be billed with HCPCS codes J0885 or Q5106.A JA or JB modifier is required.The EC modifier is also required.Inclusion of any other ICD-10 diagnoses on the claim which are non-covered with an EC modifier per NCD 110.21, will preclude payment for the ESA.DOSING:Initial dosing: 100 Units/kg TIW for 8 weeks.Maintenance dosing: After 8 weeks of initial therapy, if the response has not been satisfactory in terms of decreasing RBC transfusion or the Hblevel, then the dose may be increased by 50-100 units/kg TIW.Response should be evaluated and documented every 4-8 weeks thereafter with the dose adjusted accordingly by 50 to 100 Units/kg increments TIW. If the Hb exceeds 12 g/dL then the ESA should be stopped until the Hbdrops below 11 g/dL at which time it can be restarted at a dose reduced by at least 25%. During maintenance, dosage variations will depend on the presence of intercurrent infections and variances in Zidovudine dosing.Dosing should never exceed 300 units/kg TIW as further improvements in response are unlikely.For Anemia in Myelodysplastic Syndromes (MDS)MDS comprises a range of hematologic malignancies characterized by isolated or multiple cytopenias accompanied by abnormal cellular maturation. Much of the morbidity and death from MDS is due to the cytopenia impacts rather than transformation to acute myeloid leukemia (AML). There are well supported scenarios in which ESAs can be used as part of the therapeutic regimen in a very low, low or intermediate risk MDS population. These scenarios, for which coverage can be considered, presuming the reasonable and necessary use of ESAs is well documented, are noted below.Epoetin beta is NOT indicated for treatment of anemia in MDS.ESA use for symptomatic anemia in MDS can be considered for the following categories:
Article - Billing and Coding: Erythropoiesis Stimulating Agents (A58982)
Patients with MDS with very low, low risk (score<3) per the Revised International Prognostic Scoring System (IPSS-R), orPatients with intermediate risk (IPSS-R score<3.5), orPatients with MDS with low or intermediate- 1 risk (score of 0-1) per the International Prognostic Scoring System (IPSS), orPatients with very low, low or intermediate risk (score of 0-2) per the WHO Prognostic Scoring System (WPSS)ANDWithout del(5q) and serum EPO<500 mU/mL, orWith del(5q) and no chromosome 7 associated abnormalities, on or before starting Lenalidomide with serum EPO<500 mU/mLRequired Documentation Elements:Symptomatic anemia or transfusion dependence and a Hb < 10 g/dL within 1 week of the initial ESA treatmentThe ESA utilized:Epoetin alfa (J0885) or epoetin alfa-epbx biosimilar (Q5106) or darbepoetin (J0881)
Article - Billing and Coding: Erythropoiesis Stimulating Agents (A58982)
Weight in kilogramsMDS diagnostic bone marrow biopsy with cytogenetic analysisDocumented evaluation for other anemia contributing factors such as blood loss, hemolysis, renal failure, medications, nutritional deficiencies, thyroid dysfunction, autoimmune disorders and anemia of chronic diseaseEvaluation and treatment of other causes of anemia must occur pre-ESA initiation and at any time thereafter as needed for lack of responsiveness.Iron store results pre-ESA use: serum iron/TIBC (TSAT) and ferritin and at least every 3 months during treatmentTransferrin saturation should be at least 20%, and ferritin should be at least 100 ng/mL to start or continue ESA without correction of iron deficiency.Serum EPO result<500 mU/mLDocumented IPSS-R result of 3 or less for very low, low risk MDS or documented IPSS-R result of 3.5 or less for an intermediate risk MDS or IPSS score of 0-1 or WPSS score of 0-2.Narrative regarding ongoing response to therapyIf the initial dose of an ESA was administered in another setting (i.e., hospital, in a state outside our jurisdiction, or in another facility); subsequent office-administered ESAs must still meet all the above-mentioned requirements. This may require review of outside medical records and confirmation that needed pre-treatment lab results and evaluation were completed appropriately.
Article - Billing and Coding: Erythropoiesis Stimulating Agents (A58982)
For patients with symptomatic anemia due to low-risk categories of MDS (Very low, Low or intermediate risk IPPS-R score < 3.5), 1 of the following diagnosis codes should be present on the claim; D46.0, D46.1, D46.20, D46.21, D46.22, D46.A, D46.B, D46.C or D46.Z. In the rare case of essential thrombocythemia progressing to refractory anemia due to secondary myelofibrosis, the dual diagnoses of D47.3 and D75.81 should be reported. Waldenstrom macroglobulinemia cases complicated by neoplastic bone marrow infiltration resulting in symptomatic anemia should simply be reported with C88.0.Inclusion of any other ICD-10 diagnoses on the claim which are non-covered with an EC modifier per NCD 110.21, will preclude payment for the ESA. A JA or JB modifier is required.
Article - Billing and Coding: Erythropoiesis Stimulating Agents (A58982)
ESA use for 6-12 weeks would be expected as would RBC transfusion use for symptom management while awaiting an erythroid response.The ESA regimen should be adjusted to maintain the lowest level of Hb/HCT that is sufficient to avoid RBC transfusions. If the rise of Hb is adequate to avoid transfusions or increases > 1 g/dL in any given 2-week period, the dose of epoetin alfa should be reduced by 25% or the dose of darbepoetin alfa can be reduced by 40%. Less frequent dosing would also be an acceptable alternative.If the response is not adequate after 4 weeks, dose escalation, an increase in dose frequency or addition of a myeloid growth factor would be acceptable.ESAs should not be continued for more than 12 weeks if no response is observed.Before beginning ESA therapy, risk of thrombosis should be considered. Hypertension must be controlled.Much higher doses of ESAs are utilized as compared to all the uses noted otherwise in this article. Dosing for epoetin alfa/epoetin alfa-epbx often is in a range of 40,000-60,000 units SQ 1-2 times per week and darbepoetin alfa often in a range of 150-300 mcg SQ every other week.There is currently no consensus regarding an optimal dose/schedule for ESA administration. This decision is left to the treating oncologist.Prophylactic Allogeneic Transfusion Reduction Intent in Presurgical AnemiaDarbepoetin alfa and epoetin beta are NOT indicated for this condition.Forepoetin alfa/epoetin alfa-epbx biosimilar in anemia ina presurgical setting:For HCPCS codes J0885 or Q5106: ICD-10-CM codes D63.8 and Z01.818 MUST be billed along with 1 of the osteoarthritis codes listed in ICD-10 Group 6. The EC modifier is also required.A JA or JB modifier is required; a JB modifier would be consistent with the FDA label indication.Inclusion of any other ICD-10 diagnoses on the claim which are non-covered with an EC modifier per NCD 110.21, will preclude payment for the ESA.
Article - Billing and Coding: Erythropoiesis Stimulating Agents (A58982)
Required Documentation Elements:A presurgical Hbgreater than 10 but less than 13 g/dL.A high risk for perioperative blood loss related to planned elective orthopedic hip or knee surgery with an expectation for more than 2 units of blood lossInability or unwillingness by the patient to donate autologous bloodA workup for anemia that suggests anemia of chronic diseaseIron supplementation ongoing during the entire course of the ESADeep vein thrombosis (DVT) prophylaxis ongoing during the entire course of the ESADosing: 300 u/kg/day SQ daily for 10 days prior to surgery, on the day of surgery and daily for 4 days following surgery. The other dosing option would be 600 units/kg SQ once weekly for 3 weeks prior to the surgery (21, 14 and 7 days before surgery) plus a 4thdose on the day of surgery.
Article - Billing and Coding: MolDX: Minimal Residual Disease Testing for Hematologic Cancers (A58988)
CMS National Coverage PolicyTitle XVIII of the Social Security Act, 1833(e) prohibits Medicare payment for any claim which lacks the necessary information to process the claim.Article TextThe information in this article contains billing, coding or other guidelines that complement the Local Coverage Determination (LCD) for MolDX: Minimal Residual Disease Testing for Cancer L38779.A Minimal Residual Disease (MRD) test, as defined in the related policy, is aservicethat may include multiple components and/or multiple timepoints (i.e., serial assays).Testing schedules are set based on the validity established for the individual test comprising the service.Each component and timepoint of the service must be reasonable and necessary and adhere to the criteria set forth in the policy. The medical record must contain clear documentation of the medical necessity of this test, as per the conditions outlined in the policy.The following tests have met the criteria for coverage under the policyManufacturerTestIndicated Uses and LimitationsAdaptive BiotechnologiesClonoSeqNote:An episode of testing typically requires a baseline assay and multiple follow-up assays.Acute lymphoblastic leukemia (ALL), Multiple myeloma (MM), Chronic lymphocytic leukemia (CLL), and Diffuse Large B-Cell Lymphoma(DLBCL). Refer to CPT/HCPCS Group 2 for additional instructions and select the appropriate ICD-10 code listed under ICD-10 Codes that Support Medical Necessity Group 2 Codes.
Article - Billing and Coding: MolDX: Minimal Residual Disease Testing for Hematologic Cancers (A58988)
This Table will be updated to reflect revisions and additions of newly covered tests.Coverage of CLONOSEQfor other cancer indications and episodes of care, and modifications to the definition of an episode of care will be evaluated as needed.Additional process requirements for coverage and billing:MolDX may make available specific forms to assist with test Technical Assessments (TAs). Please follow the instructions on the MolDX website to assist with this process. If such forms are available that pertain to the test type in question, these forms are required for successful coverage determinations.Single-gene PCR tests:For patients with or without cancer (as defined in the policy),established standard-of-careMRD tests using single-genePCR(i.e., BCR-ABL1)may be billed on an individual basis according to testing schedules outlined in national (i.e., NCCN) or society guidelines, with 1 UOS for each date of service.Refer to CPT/HCPCS Group 3 for additional instructions and select the appropriate ICD-10 code listed under ICD-10 Codes that Support Medical Necessity Group 3 Codes.Regarding single-gene and panel testing of genes  Refer to definitions and instructions in Billing and Coding: MolDX: Testing of Multiple Genes A57503 and Billing and Coding: MolDX: Molecular Diagnostic Tests (MDT) A56853
Article - Billing and Coding: MolDX: Minimal Residual Disease Testing for Hematologic Cancers (A58988)
Regarding single-gene and panel testing of genes  Refer to definitions and instructions in Billing and Coding: MolDX: Testing of Multiple Genes A57503 and Billing and Coding: MolDX: Molecular Diagnostic Tests (MDT) A56853Other tests (i.e., ClonoSeq):For patients with cancer, the unit of service for this type of test is 1. Billing should occur at the start of the episode of testing. Regarding the use of NGS-based MRD tests (i.e., ClonoSeq) in patients with cancer Theservicemay be performed once per patient per cancer diagnosis, unless there is clinical evidence ofa priorichange in genetic content.For patients without cancer (as defined in the policy), a second kind of test may exist wherein asingletimepointmay constitute a single test (i.e., 1 UOS for a given date of service). Testing in these patients will be accompanied by the appropriate Personal history of cancer ICD-10 code. Testing may not be performed more than once in a month; the testing schedule is set based on the validity established of the individual test for the given indication.Refer to additional instructions outlined in the relevant Group sections below.Regarding NGS panels:To submit a claim for MRD analysis by NGS that measures multiple analytes, use CPT81479 and one (1) UOS with the assigned DEX Z-Code.Billing instructions:Billing requires a Z-identifier code to be submitted with the claim. All tests must be registered with the DEXDiagnostic Exchange application.To report an episode of testing, please submit the following claim information:Select the appropriate CPTcode.If no specific CPT code exists for the test submitted, bill with the NOC code 81479.Enter 1 unit of service (UOS)Enter the appropriate DEX Z-Codeidentifier adjacent to the CPTcode in the comment/narrative field for the following Part B claim field/types:Loop 2400 or SV101-7 for the 5010A1 837PBox 19 for paper claim
Article - Billing and Coding: MolDX: Minimal Residual Disease Testing for Hematologic Cancers (A58988)
Enter the appropriate DEX Z-Codeidentifier adjacent to the CPTcode in the comment/narrative field for the following Part A claim field/types:Line SV202-7 for 837I electronic claimBlock 80 for the UB04 claim formSelect the appropriate ICD-10-CM codeNOTE:When entering the DEX Z-Codeon the SV101-7 documentation field for Part B claims please do not add additional characters and/or information on the line.
Article - Billing and Coding: Epidural Steroid Injections for Pain Management (A58993)
CMS National Coverage PolicyInternet-Only Manuals (IOMs)CMS IOM Publication 100-03,Medicare National Coverage Determinations (NCD) Manual,Chapter 1, Part 4, Section 280.14 Infusion PumpsCMS IOM Publication 100-04, Medicare Claims Processing Manual,Chapter 23, Section 20.9 National Correct Coding Initiative (NCCI)Social 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 Text