(Medicare Claims Processing Manual)

In some cases, physicians may believe there is medical justification to maintain a hematocrit above 39.0% or hemoglobin above 13.0g/dL.  Beneficiaries, physicians, and/or renal facilities  may submit additional medical documentation to justify this belief under the routine appeal process.  You may reinstate any covered dosage reduction amounts under this first level appeal process when you believe the documentation supports a higher hematoc rit/hemoglobin level.   Providers are reminded that, in accordance with FDA labeling, CMS expects that as the hematocrit approaches 36.0% (hemoglobin 12.0g/dL), a dosage reduction occurs.  Providers are expected to maintain hematocrit levels between 30.0 to  36.0% (hemoglobin 10.0- 12.0g/dL).  Hematocrit levels that remain below 30.0% (hemoglobin levels below 10.0g/dL)) despite dosage increases, should have causative factors evaluated.  The patients medical record should reflect the clinical reason for dose changes and hematocrit levels outside the range of 30.0- 36.0% (hemoglobin levels 10.0- 12.0g/dL). Medicare contractors may review medical records to assure appropriate dose reductions are applied and maintained and hematological target ranges are maintained.   These hematocrit requirements apply only to ESAs furnished as an ESRD benefit under 1881(b) of the Social Security Act.   Effective January 1, 2020, the EMP is discontinued under the ESRD PPS. Prescribi ng practitioners should continue to prescribe ESAs in accordance with ESA dosing guidelines and ESRD facilities should continue to report what they furnish.   The type of bill 72X will no longer be subject to dose reductions or ESA dose limitations.  ESRD facilities are not required to report the following modifiers:  1. GS -  Dosage of erythropoietin stimulating agent has been reduced and maintained in response to hematocrit or hemoglobin level  2. ED -  Hematocrit level has exceeded 39% (or hemoglobin level has exceeded 13.0 g/dl) for 3 or more consecutive billing cycles immediately prior to and including the current cycle  3. EE -  Hematocrit level has not exceeded 39% (or hemoglobin level has not exceeded 13.0 g/dl) for 3 or more consecutive billing cy cles immediately prior to and including the current cycle     Medically Unlikely Edits (MUE)   For dates of service on and after January 1, 2008, the MUE for claims billing for Epogen is reduced to 400,000 units from 500,000. The MUE for claims for Aranesp  is reduced to 1200 mcg from 1500 mcg.   It is likely that claims reporting doses exceeding the threshold reflect typographical errors and will be returned to providers for correction.  Effective January 1, 2020 the medically unlikely edits for ESAs  exceeding the threshold limits above are discontinued under the ESRD PPS.  60.4.2 - Facility Billing Requirements for ESAs (Rev. 10640, Issued:08- 06-21, Effective:09- 07-21, Implementation:09- 07-21) Hematocrit and Hemoglobin Levels  Renal dialysis facilitie s are required to report hematocrit or hemoglobin levels for their Medicare patients receiving erythropoietin products.  Hematocrit levels are reported in value code 49 and reflect the most recent reading taken before the start of the billing period.  Hemo globin readings before the start of the billing period are reported in value code 48.   To report a hemoglobin or hematocrit reading for a new patient on or after January 1, 2006, the provider should report the reading that prompted the treatment of epoetin alfa.  The provider may use results documented on form CMS 2728 or the patient's medical records from a transferring facility.   Effective January 1, 2012, ESRD facilities are required to report hematocrit or hemoglobin levels on all ESRD claims.  Reportin g the value 99.99 is not permitted when billing for an ESA.   The revenue codes for reporting Epoetin Alfa are 0634 and 0635.  All other ESAs are reported using revenue code 0636.  The HCPCS code for the ESA must be included:  HCPCS  HCPCS Description  Dates of Service  Q4055 Injection, Epoetin Alfa, 1,000 units (for ESRD on Dialysis)  1/1/2004 through 12/31/2005 HCPCS  HCPCS Description  Dates of Service  J0886  Injection, Epoetin Alfa, 1,000 units (for ESRD on Dialysis)  1/1/2006 through 12/31/2006 Q4081 Injection, Epoetin alfa, 100 units (for ESRD on Dialysis)  1/1/2007 to present  Q4054 Injection, Darbepoetin Alfa, 1mcg (for ESRD on Dialysis)  1/1/2004 through 12/31/2005 J0882  Injection, Darbepoetin Alfa, 1mcg (for ESRD on Dialysis)  1/1/2006 to present  J0890  Injection, Peginesatide,  0.1 mg (for ESRD on Dialysis) 1/1/2013 through 7/1/2015 Q5105 Injection, epoetin alfa, biosimilar, (Retacrit) (For ESRD on Dialysis), 100 units  7/1/2018  to present   Each administration of an ESA is reported on a separate line item with the units reported used as a multiplier by the dosage description in the HCPCS to arrive at the dosage per administration.  Route of Administration Modifiers  Patients with ESRD) receiving administrations of ESA for the treatment of anemia may receive intravenous administration or subcutaneous administrations of the ESA.  Effective for claims with dates of services on or after January 1, 2012, all facilities billing for injections of ESA for ESRD beneficiaries must include the modifier JA on the claim to indicate an intravenous administration or modifier JB to indicate a subcutaneous administration. ESRD claims containing ESA administrations that are submitted without the route of administration modifiers will be returned to the provider for correction. Renal dialysis facility cl aims including charges for administrations of the ESA by both methods must report separate lines to identify the number of administration provided using each method.   Effective July 1, 2013, providers must identify when a drug is administered via the dialy sate by appending the modifier JE (administered via dialysate).   Maximum Allowable Administrations  The maximum number of administrations of EPO for a billing cycle is 13 times in 30 days and 14 times in 31 days.  The maximum number of administrations of Aranesp for a billing cycle is 5 times in 30/ 31days.  Number of Units Administered -  Subsequent claims may be submitted electronically.   Number of Units Administered -  Subsequent claims may be submitted electronically.   60.4.4 - Payment Amount for Epoetin Alfa (EPO)  (Rev. 10640, Issued:08- 06-21, Effective:09- 07-21, Implementation:09- 07-21)  Payment for ESRD -related EPO is included in the ESRD PPS for claims with dates of service on or after January 1, 2011.   60.4.4.1 - Payment for Epoetin Alfa (EPO) in Other Settings  (Rev. 10640, Issued:08- 06-21, Effective:09- 07-21, Implementation:09- 07-21)  With the implementation of the ESRD PPS, ESRD -related EPO is included in ESRD PPS payment amount and is not separately payable on Part B cl aims with dates of service on or after January 1, 2011 for other providers with the exception of a hospital billing for an emergency or unscheduled dialysis session.  In the hospital inpatient setting, payment under Part A is included in the DRG.  In the hospital inpatient setting, payment under Part B is made on bill type 12x. Hospitals report the drug units based on the units defined in the HCPCS description.  Hospitals do not report value code 68 for units of EPO.  For dates of service prior to April 1, 2006, report EPO under revenue code 0636.  For dates of service from April 1, 2006 report EPO under the respective revenue code 0634 for EPO less than 10,000 units and revenue code 0635 for EPO over 10,000 units. Payment will be based on the ASP Pricing Fil e.    In a skilled nursing facility (SNF), payment for EPO covered under the Part B EPO benefit is not included in the prospective payment rate for the residents Medicare -covered SNF stay.   In a hospice, payment is included in the hospice per diem rate when treatment is related to the terminal illness .  For a service furnished by a physician or incident to a physicians service, payment is made to the physician by the A/B MAC (B) in accordance with the rules for incident to services.  When EPO is administered in the renal facility, the service is not an incident to service and not under the incident to provision.  60.4.4.2 - Epoetin Alfa (EPO) Provided in the  Hospital Outpatient Departments  (Rev. 2582, Issued: 11- 02-12, Effective: 04- 01-13, Implementation: 04 -01-13)  When ESRD patients come to the hospital for an unscheduled or emergency dialysis treatment they may also require the administration of EPO.  Effective January 1, 2005, EPO will be paid based on the ASP Pricing File.   Hospitals us e type of bill 13X (or 85X for Critical Access Hospitals) and report charges under the respective revenue code 0634 for EPO less than 10,000 units and revenue code 0635 for EPO over 10,000 units.  Hospitals report the drug units based on the units defined in the HCPCS description.  Hospitals do not report value code 68 for units of EPO.  Value code 49 must be reported with the hematocrit value for the hospital outpatient visits prior to January 1, 2006, and for all claims with dates of service on or after J anuary 1, 2008.   60.4.5.1 - Self Administered ESA Supply  (Rev. 10640, Issued:08- 06-21, Effective:09- 07-21, Implementation:09- 07-21)  Initially, facilities may bill for up to a 2 -month supply of an ESA for  home dialysis  beneficiaries who meet the criteria f or selection for self -administration. After the initial two months supply, the facility will bill for one months supply at a time. Condition code 70 is used to indicate payment requested for a supply of an ESA furnished a beneficiary. Usually, revenue co de 0635 would apply to EPO since the supply would be over 10,000 units. Facilities leave FL 46, Units of Service, blank since they are not administering the drug.  For claims with dates of service on or after January 1, 2008, supplies of an ESA for self -administration  should be billed according to the pre -determined plan of care schedule provided to the beneficiary.  Submit a separate line item for each date an administration is expected to be performed with the expected dosage.  In the event that the schedule was changed, the provider should note the changes in the medical record and bill according to the revised schedule.  For patients beginning to self -administer an ESA at home receiving an extra month supply of the drug, bill the one month reserve supply on one claim line and include modifier EM defined as Emergency Reserve Supply (for ESRD benefit only).   When billing for drug wastage in accordance with the policy in chapter 17 of this manual, section 40.1 the provider must show the wastage on a separat e line item with the modifier JW.  The line item date of service should be the date of the last covered administration according to the plan of care or if the patient dies use the date of death.   Condition code 70 should be reported on claims billing for home dialysis patients who   self-administer  anemia management drugs including ESAs.