evekhm/cms_iom_500 huggingface dataset:
Article - Billing and Coding: MolDX: Plasma-Based Genomic Profiling in Solid Tumors (A58973)
CMS National Coverage PolicyTitle XVIII of the Social Security Act, 1833(e), prohibits Medicare payment for any claim lacking the necessary documentation to process the claimCMS Internet-Only Manual, Publication 100-02, Medicare Benefit Policy Manual, Chapter 15,  80.1.2 A/B MAC (B) Contracts With Independent Clinical LaboratoriesCMS Internet-Only Manual, Publication 100-04, Medicare Claims Processing Manual, Chapter 23, 10 Reporting ICD Diagnosis and Procedure CodesArticle TextThe information in this article contains billing, coding or other guidelines that complement the Local Coverage Determination (LCD) for MolDX: Plasma-Based Genomic Profiling in Solid Tumors L39230.To report a Plasma-Based Genomic Profiling in Solid Tumors service, please submit the following claim information:Select the appropriate CPTcodeEnter 1 unit of service (UOS)Enter the appropriate 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 the appropriate 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 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: MolDX: Plasma-Based Genomic Profiling in Solid Tumors (A58975)
CMS National Coverage PolicyTitle XVIII of the Social Security Act, 1833(e), prohibits Medicare payment for any claim lacking the necessary documentation to process the claimCMS Internet-Only Manual, Publication 100-02, Medicare Benefit Policy Manual, Chapter 15,  80.1.2 A/B MAC (B) Contracts With Independent Clinical LaboratoriesCMS Internet-Only Manual, Publication 100-04, Medicare Claims Processing Manual, Chapter 23, 10 Reporting ICD Diagnosis and Procedure CodesArticle TextThe information in this article contains billing, coding or other guidelines that complement the Local Coverage Determination (LCD) for MolDX: Plasma-Based Genomic Profiling in Solid Tumors L39232.To report a Plasma-Based Genomic Profiling in Solid Tumors service, please submit the following claim information:Select the appropriate CPTcodeEnter 1 unit of service (UOS)Enter the appropriate 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 the appropriate 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 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: Erythropoiesis Stimulating Agents (A58982)
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.Title XVIII of the Social Security Act, 1842(u) Each request for payment, or bill submitted, for a drug furnished to an individual for the treatment of anemia in connection with the treatment of cancer shall include information on the hemoglobin or hematocrit levels for the individual.Title XVIII of the Social Security Act, 1881(b)(11)(B)(i) allows payment for erythropoietin provided by a physician.CMS Internet-Only Manual, Pub. 100-02, Medicare Benefit Policy Manual, Chapter 6, 10.2 Other Circumstances in Which Payment Cannot Be Made Under Part A and 30 Drugs and BiologicalsCMS Internet-Only Manual, Pub. 100-02, Medicare Benefit Policy Manual, Chapter 11, 20.3 Drugs and Biologicals, 30.1 Home Dialysis Items and Services, and 100.6 Applicability of Specific ESRD PPS Policies to AKI DialysisCMS Internet-Only Manual, Pub. 100-02, Medicare Benefit Policy Manual, Chapter 15, 50.5.2 Erythropoietin (EPO), 50.5.2.1 Requirements for Medicare Coverage for EPO, and 50.5.2.2 Medicare Coverage of Epoetin Alfa (Procrit) for Preoperative UseCMS Internet-Only Manual, Pub. 100-03, Medicare National Coverage Determinations (NCD) Manual, Chapter 1, Part 2, 110.21 Erythropoiesis Stimulating Agents (ESAs) in Cancer and Related Neoplastic ConditionsCMS Internet-Only Manual, Pub. 100-04, Medicare Claims Processing Manual, Chapter 4, 10 Hospital Outpatient Prospective Payment System (OPPS), 20 Reporting Hospital Outpatient Services Using Healthcare Common Procedure Coding System (HCPCS), 50.1 Outpatient Provider Specific File, and 200.2 Hospital Dialysis Services For Patients with and without End Stage Renal Disease (ESRD)
Article - Billing and Coding: Erythropoiesis Stimulating Agents (A58982)
CMS Internet-Only Manual, Pub. 100-04, Medicare Claims Processing Manual, Chapter 6, 20 Services Included in Part A PPS Payment Not Billable Separately by the SNF, 20.2.1 Dialysis and Dialysis Related Services to a Beneficiary With ESRD, and 20.2.1.1 ESRD ServicesCMS Internet-Only Manual, Pub. 100-04, Medicare Claims Processing Manual, Chapter 7, 100 Epoetin (EPO)CMS Internet-Only Manual, Pub. 100-04, Medicare Claims Processing Manual, Chapter 8, 10.5 Hospital Services, 40 Acute Kidney Injury (AKI) Claims, 50.2 Drugs and Biologicals Included in the End Stage Renal Disease Prospective Payment System (ESRD)(PPS), 50.3 Required Information for In-Facility Claims Paid Under the End Stage Renal Disease Prospective Payment System ESRD PPS, 60.2 Drugs Furnished in Dialysis Facilities, 60.2.1.1 Separately Billable ESRD Drugs, 60.2.1.2 Facilities Billing for ESRD Drugs and Biologicals Equivalent to Injectable Drugs, 60.4 Erythropoietin Stimulating Agents (ESAs), 60.4.1 ESA Claims Monitoring Policy, 60.4.2 Facility Billing Requirements for ESAs, 60.4.4 Payment Amount for Epoetin Alfa (EPO), 60.4.4.1 Payment for Epoetin Alfa (EPO) in Other Settings, 60.4.4.2 Epoetin Alfa (EPO) Provided in the Hospital Outpatient Departments, 60.4.6.1 Reserved for Future Use, 60.4.6.2 Reserved for Future Use, 60.4.6.3 Payment Amount for Darbepoetin Alfa (Aranesp), 60.4.6.4 Payment for Darbepoetin Alfa (Aranesp) in Other Settings, and 60.4.6.5 Payment for Darbepoetin Alfa (Aranesp) in the Hospital Outpatient Department
Article - Billing and Coding: Erythropoiesis Stimulating Agents (A58982)
CMS Internet-Only Manual, Pub. 100-04, Medicare Claims Processing Manual, Chapter 17, 10 Payment Rules for Drugs and Biologicals, 20.5.8 Injections Furnished to ESRD Beneficiaries, 40.1 Discarded Erythropoietin Stimulating Agents for Home Dialysis, 80.5 Self-Administered Drugs, 80.8 Reporting of Hematocrit and/or Hemoglobin Levels, 80.9 Required Modifiers for ESAs Administered to Non-ESRD Patients, 80.10 Hospitals Billing for Epoetin Alfa (EPO) and Darbepoetin Alfa (Aranesp) for Non-ESRD Patients, 80.11 Requirements for Providing Route of Administration Codes for Erythropoiesis Stimulating Agents (ESAs), and 80.12 Claims Processing Rules for ESAs Administered to Cancer Patients for Anti-Anemia TherapyCMS Internet-Only Manual, Pub. 100-04, Medicare Claims Processing Manual, Chapter 30 Financial Liability ProtectionsMedicare Learning Network (MLN) Matters (MM5818); Effective Date July 30, 2007
Article - Billing and Coding: Erythropoiesis Stimulating Agents (A58982)
Medicare Learning Network (MLN) Matters (MM5699); Effective Date January 1, 2008Article TextThe information in this article contains billing, coding or other guidelines that complement the Local Coverage Determination (LCD) for Erythropoiesis Stimulating Agents L39237.Part A and B:General Information for Erythropoiesis Stimulating Agents (ESA) Claims:It is not appropriate to bill Medicare for services that are not covered as if they are covered. When billing for non-covered services, use the appropriate modifier.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.No ESA should be given within the context of uncontrolled hypertension.No ESA should be used to replace red blood cell (RBC) transfusions in patients who need immediate urgent correction of anemia.With any ESA, the patients medical record should reflect the clinical reason for dose changes and hematocrit (HCT) levels outside the range of 30.0-36.0% (hemoglobin (Hb) levels 10.0-12.0 g/dL). Medicare contractors may review medical records to assure appropriate dose reductions are applied and maintained and hematological target ranges are maintained.There may be instances when a patient has a chronic health condition not specifically addressed in this policy for which an ESA is useful treatment. Such scenarios would be expected to demonstrate considerable transfusion dependence and anemia-related symptoms. In the event of denials, an appeals process will allow the opportunity for the provider to substantiate a reasonable and necessary basis for ESA treatment based on medical literature, specialty organization best practice alignment, and the unique clinical circumstances for the beneficiary. Explanatory documentation within the medical record is crucial.HCPCS Drug Codes:
Article - Billing and Coding: Erythropoiesis Stimulating Agents (A58982)
HCPCS Drug Codes:Healthcare Common Procedure Coding System (HCPCS) codes J0881, J0885, J0888, and Q5106 are for use in patients with non-end stage renal disease (non-ESRD) conditions.HCPCS codes J0882, J0887, Q4081, and Q5105 are intended for use only with patients who have ESRD and are on dialysis.Modifiers:-EA, EB, ECAllnon-ESRD claims reporting HCPCS code J0881, J0885, J0888, or Q5106 and ESRD claims reporting J0882, J0887, Q4081, and Q5105 must report 1,and only 1,of the following modifiers:EA:ESA administered to treat anemia due to anticancer chemotherapyEB: ESA administered to treat anemia due to anticancer radiotherapyEC: ESA administered to treat anemia not due to anticancer radiotherapy or anticancer chemotherapyESA claims, either institutional or professional, that do not report 1 of the above 3 modifiers will be returned to the provider.Non-ESRD ESA claims that report the ESA modifier EC and any of the following conditions will be denied as not reasonable and necessary:Any anemia in cancer or cancer treatment patients due to:Folate deficiencyB-12 deficiencyIron deficiencyHemolysisBleedingBone marrow fibrosisAnemia associated with the treatment of acute and chronic myelogenous leukemias (CML, AML) or erythroid cancersAnemia of cancer not related to cancer treatmentProphylactic use to prevent chemotherapy-induced anemiaProphylactic use to reduce tumor hypoxiaPatients with erythropoietin (EPO)-type resistance due to neutralizing antibodiesAnemia due to cancer treatments if patients have uncontrolled hypertension
Article - Billing and Coding: Erythropoiesis Stimulating Agents (A58982)
Non-ESRD ESA services for J0881, J0885 or Q5106 billed with modifier -EC will be denied in the presence of various secondary ICD-10 codes that are non-covered per CMS.https://www.cms.gov/Medicare/Coverage/DeterminationProcess/downloads/CR12027.zipNon-ESRD ESA services for J0881, J0885 and Q5106 are not considered reasonable and necessary within the context of other medical conditions for which resolution would be expected prior to starting or to continue ESA administration. Such conditions would include, but not be limited to: iron/vitamin B12/folate deficiencies, G6PD deficiency, pyridoxine deficiency, various forms of hemolysis, hereditary spherocytosis, and pure red cell aplasias. The presence of any of these conditions would reduce the therapeutic impact and effectiveness of the ESA. Additionally, the presence of an unspecified anemia code suggests appropriate evaluation, to determine the nature of the treated anemia, has not been completed.Non-ESRD ESA claims that report HCPCS J0881, J0885, J0888 or Q5106 billed with ESA modifier EB (ESA, anemia, radio-induced) will be denied.Non-ESRD ESA claims that report HCPCS J0881, J0885, J0888 or Q5106 billed with modifier EA (ESA, anemia, chemo-induced) for anemia secondary to myelosuppressive anticancer chemotherapy in solid tumors, multiple myeloma, lymphoma, and lymphocytic leukemia when a Hb 10.0g/dL or greater or HCT30.0% or greater will be denied.-JA, JB, JERoute of administration is important information especially with drugs that can be given multiple different ways.All non-ESRD claims reporting HCPCS code J0881, J0885, J0888, or Q5106 and all ESRD claims reporting J0882, Q4081, and Q5105 must also be reported with 1, and only 1, of the following modifiers:
Article - Billing and Coding: Erythropoiesis Stimulating Agents (A58982)
JA-Administered intravenously (IV)JB-Administered subcutaneously (SQ)JE-Administered via dialysate-GA, GX, GY or GZ
Article - Billing and Coding: Erythropoiesis Stimulating Agents (A58982)
-GA, GX, GY or GZAn Advance Beneficiary Notice of Noncoverage (ABN) may be used for services which are likely to be non-covered, whether for medical necessity or for other reasons. Non-covered services should be billed with modifier GA (Waiver of liability statement issued as required by payer policy, individual case) when the provider wants to indicate that it is anticipated Medicare will deny a specific service as not reasonable and necessary and an ABN signed by the beneficiary is on file, with -GX (Notice of liability issued, voluntary under payer policy) when the beneficiary has signed an ABN, and a denial is anticipated based on provisions other than medical necessity, such as statutoryexclusions of coverage or technical issues, with -GY (Item or service statutorily excluded, does not meet the definition of any Medicare benefit or, for non-Medicare insurers, is not a contract benefit, or with GZ (Item or service expected to be denied as not reasonable and necessary) when the provider wants to indicate that it is expected that Medicare will deny a service as not reasonable and necessary and that an ABN has not been signed by the beneficiary, as appropriate.Claims Reporting-Hemoglobin/HematocritClaims billing for the administration of an ESA (HCPCS codes J0881, J0882, J0885, J0887, J0888, Q4081, Q5105 and Q5106) must report the most recent HCT or Hbreading. Claims not reporting this information will be returned to the provider.For institutional claims, the Hb reading is reported with a value code 48 and a HCT reading is reported with the value code 49.For professional paper claims, test results are reported in item 19 of the Form CMS-1500 claim form. For electronic claims (837P), providers report the Hb or Hct readings in Loop 2400 MEA segment. The specifics are mEA01=TR (for test results), MEA02=R1 (for Hb) or R2 (for HCT), and MEA03=the test results.Documentation Requirements
Article - Billing and Coding: Erythropoiesis Stimulating Agents (A58982)
The medical record documentation for patients receiving ESA therapy must support the reasonable and necessary basis for such therapy.All 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.For any ESA, the medical record must reflect that ESA therapy for the individualized patient is reasonable and necessary. The medical record must document the most recent blood pressure and demonstrate reasonable control not in significant excess of a baseline range for a given patient, weight in kilograms, date and results of HCT or Hb level prior to the administration of ESA therapy, evidence of assessment ruling out other causative factors of anemia or, if causative factors are present, that they have been managed and that it is still necessary to initiate ESA. The dosage and route of administration must be documented.ESRD on Dialysis ESA Claims with Modifier ECFor patients with ESRD who are on dialysis, HCPCS codes J0882, J0887, Q4081, and Q5105 are not paid by Medicare Part B. ESAs for ESRD on dialysis are included in the composite rate for the ESRD facility. If an ESA is administered to a patient with ESRD on dialysis by a provider other than the patients ESRD provider, the administering provider must submit a claim to the ESRD provider for the service. The administering provider must not submit a claim to Medicare Part B.Required Documentation Elements:The ESA utilized:Darbepoetin alfa (J0882) or epoetin alfa (Q4081) or epoetin alfa-epbx biosimilar (Q5105) or epoetin beta (J0887)
Article - Billing and Coding: Erythropoiesis Stimulating Agents (A58982)
Use of the ESA for specific diagnoses indicatingsymptomaticanemia of chronic kidney disease (CKD) on dialysisFor patients with ESRD who are on dialysis, a diagnosis of D63.1 and a diagnosis of N18.6 must be billed with HCPCS code J0882, J0887, Q4081, or Q5105. The EC modifier is also required. A JA, JB or JE 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, will preclude payment for the ESA.Use of an appropriate dose, route (IV administration is recommended for use in ESRD), and frequency.DOSING:For initial dosing ofdarbepoetin alfa in ESRD: 0.45 mcg/kg weekly or 0.75 mcg/kg every 2 weeks.For initial dosing ofepoetin alfa/epoetin alfa-epbx biosimilar in ESRD: 50-100 u/kg three times per week (TIW) or if appropriate for the patient, a weekly dose of 75-150 u/kg SQ/IV every weekA typical therapeutic dose range would be 50-300 u/kg TIW.Maintenance dosing range: 12.5-525 u/kg TIWFor initial dosing ofepoetin beta in ESRD: 6 mcg/kg body weight administered as a single IV or SQ injection once every 2 weeks.Maintenance dosing: Once the Hb has been stabilized, epoetin beta may be administered once monthly using a dose that is twice that of the every 2-week dose and subsequently titrated as necessary.
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 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.The maximum number of administrations of epoetin alfa/biosimilar for a billing cycle is 13 times in 30 days and 14 times in 31 days. The maximum number of administrations of darbepoetin for a billing cycle is 5 times in 30/31days.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 and during 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.
Article - Billing and Coding: Erythropoiesis Stimulating Agents (A58982)
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 ESA claims may prompt a Medicare Administrative Contractor (MAC) request for documentation regarding the clinical criteria supporting the initial administration as well as the need to continue the ESA. 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 CKD NOT on Dialysis with Modifier EC ESA Claims:The term without dialysis refers to patients that are not on a regular course of maintenance dialysis. For patients who need occasional rescue dialysis, it would be appropriate to bill HCPCS code J0881, J0885, J0888, or Q5106 since these patients are not on a regular course of maintenance dialysis.The National Kidney Foundation's Kidney Disease Outcomes Quality Initiative (NKF-K/DOQI) guidelines rely on the third National Health and Nutrition Examination Survey (NHANES III) data analysis regarding a relationship of HCT levels with stage of CKD. Based on this analysis, patients with glomerular filtration rate (GFR) < 30 mL/min/1.73 m2commonly demonstrated severe anemia with HCT levels < 33%. Thus, a GFR < 45 mL/min/1.73m2is a reasonable threshold to support ESA administration in conjunction with sufficiently low and symptomatic Hb/HCTlevels.Required Documentation Elements:Serum creatinine and/or GFRThe ESA utilized:Darbepoetin alfa (J0881) or epoetin alfa (J0885) or epoetin alfa-epbx biosimilar (Q5106) or epoetin beta (J0888)Use of the ESA for specific diagnoses indicatingsymptomaticanemia of CKD not on dialysisFor patients with CKD who are not on dialysis, a diagnosis code of D63.1anda diagnosis of I12.0, I13.11, I13.2, N18.32, N18.4, or N18.5 must be billed with HCPCS code J0881, J0885, J0888, or Q5106. The EC 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, will preclude payment for the ESA.
Article - Billing and Coding: Erythropoiesis Stimulating Agents (A58982)
Note: Patients with stage I and II and IIIa CKD do not meet the GFR requirements in coverage criteria for the following combination ICD-10 codes:I12.9I13.0Use of an appropriate dose, route, and frequency.DOSING:For initial dosing ofdarbepoetin alfa in non dialysis CKD: 0.45 mcg/kg IV or SQ every 4 weeksFor initial dosing ofepoetin alfa/epoetin alfa-epbx biosimilar in non dialysis CKD: 50-100 u/kg TIW or, if appropriate for the patient, a weekly dose of 75-150 u/kg SQ/IV every week.Maintenance dosing range: A therapeutic dose range would be 50-300 u/kg TIW and more typically, 75 to 150 units/kg/week.For initial dosing ofepoetin beta in CKD NOT on dialysis CKDin adultCKD patients who not currently treated with an ESA: 0.6 mcg/kg body weight administered as a single IV or SQ injection once every 2 weeks.Maintenance dosing range: Once the Hb has been stabilized, epoetin beta may be administered once monthly using a dose that is twice that of the every-2-week dose and subsequently titrated as necessary.