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)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.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.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.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.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.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 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)