(Medicare Claims Processing Manual)

60.2.2 - Drug Payment Amounts for Facilities  (Rev. 10640, Issued:08- 06-21, Effective:09- 07-21, Implementation:09- 07-21) Effective for claims with dates of service on or after January 1, 2011 all drugs and biologicals used in the treatment of ESRD  are reimbursed under the ESRD PPS payment amount. For more information, please refer to Chapter 11 Benef it Policy Manual, section 20.3 Drugs and Biologicals.   60.2. 3 - Facility Billing Requirements to the A/B MAC ( A)                   (Rev. 10640, Issued:08- 06-21, Effective:09- 07-21, Implementation:09- 07-21)   See Medicare Benefit Policy Manual, Chapter 11 for coverage and effective dates applicable to intravenous iron therapy services.   For claims with dates of service on or after December 1, 2000, sodium ferric gluconate complex in sucrose injection is covered by Medicare for first line treatment of iron deficiency anemia in patients undergoing chronic hemodialysis who are receiving supplemental erythropoeitin therapy.  Payment is made on a reasonable cost basis for claims with dates of service on or after December 1, 2000 in renal dialysis centers (freesta nding facilities).  Payment is made pursuant to 42 CFR 405.517 for claims with dates of service on or after January 1, 2001.   For claims with dates of service on or after October 1, 2001, Medicare also covers iron sucrose injection as a first line treatment of iron deficiency anemia when furnished intravenously to patients undergoing chronic hemodialysis who are receiving supplemental erythropoeitin therapy.  Payment is made under the outpatient prospective payment system for hospital outpatient departments.  Payment is made on a reasonable cost basis in CAHs and in renal dialysis centers (freestanding facilities). See Chapter 17. Deductible and coinsurance apply.   Facilities bill the A/B MAC (A) using type  of bill 72X and revenue code 0636. For claims with dates of service on or after December 1, 2000, report HCPCS code J3490 (Unclassified drugs) for sodium ferric gluconate complex in sucrose injection.  For claims with dates of service on or after January 1, 2001, facilities report HCPCS code J2915 for sodium ferric gluconate complex in sucrose injection.  Until a specific code is developed for iron sucrose injection, report HCPCS code J3490 (Unclassified drugs).   60.2. 4 - Physician Billing Requirements to the A/B MAC (B)               (Rev. 10640, Issued:08- 06-21, Effective:09- 07-21, Implementation:09- 07-21)  A.   Sodium Ferric Gluconate Complex in Sucrose Injection   Sodium Ferric Gluconate Complex in sucrose injection may be payable for claims with dates of service on or after December 1, 2000 when furnished intravenously, for first line treatment of iron deficiency anemia in patients undergoing chronic hemodialysis w ho are receiving supplemental erythropoeitin therapy.  Physicians bill and A/B MACs (B) pay for HCPCS code J1756 when submitted with a primary diagnosis for chronic renal failure and a secondary diagnosis for iron deficiency anemia.   These diagnoses are l isted below.  Use ICD -9-CM or ICD -10-CM as applicable for the service date.   Chronic Renal Failure (Primary Diagnosis)   ICD-9-CM  585  ICD-10-CM  N18.3, N18.4, N18.5, N18.6,  Iron Deficiency Anemia (Secondary Diagnosis)   ICD-9-CM  280.0, 280.1, 280.8, or 280.9  ICD-10-CM  D50.0, D50.1, D50.8, D50.9, or D63.1  This benefit is subject to the Part B deductible and coinsurance and should be paid per current Medicare drug payment reimbursement rules.   B.   Iron Sucrose Injection   Iron Sucrose injections are pay able for claims with dates of service on or after October 1, 2001, when furnished intravenously, for first line treatment of iron deficiency anemia in patients undergoing chronic hemodialysis who are receiving supplemental erythropoeitin therapy.  Until a specific code for iron sucrose injection is developed, providers must submit HCPCS code J1756, with the appropriate explanation of drug name and dosage entered on the claim.  The primary diagnosis code for chronic renal failure and one of the following sec ondary diagnosis codes for iron deficiency must be entered.   These diagnoses are listed below.  Use ICD -9-CM or ICD -10-CM as applicable for the service date.   Chronic Renal Failure (Primary Diagnosis)   ICD-9-CM -  585  ICD-10-CM -  N18.3, N18.4, N18.5, N18.6,  Iron Deficiency Anemia (Secondary Diagnosis)   ICD-9-CM  280.0, 280.1, 280.8, or 280.9  ICD-10-CM  D50.0, D50.1, D50.8, D50.9,D63.1   Iron sucrose injection is subject to the Part B deductible and coinsurance and should be paid per current Medicare drug pay ment reimbursement rules. A/B MACs (B) may cover other uses of this drug at their discretion.   C.   Messages for Use with Denials   The contractor shall deny claims for sodium ferric gluconate complex in sucrose injection or iron sucrose injection due to a missing diagnosis code.   The contractor shall use the following remittance advice messages and associated codes when rejecting/denying claims under this policy.  This CARC/RARC combination is compliant with CAQH CORE Business Scenario Two.  Group Code: CO  CARC: 16  RARC: M76  MSN: 9.2  60.3 - Blood and Blood Products  Furnished in Hospital Based and Independent Dialysis Facilities                                                                (Rev. 10640, Issued:08- 06-2021, Effective:09- 07-2021, Implementation :09-07-2021)   Effective January 1, 2011,blood and blood products remain separately payable under the ESRD PPS. However, the staff time associated with administering blood and blood products is included in the ESRD PPS payment amount.  60.4 - Erythropoietin Stimulating Agents (ESAs)  (Rev. 10640, Issued:08- 06-21, Effective:09- 07-21, Implementation:09- 07-21)  Coverage rules for ESAs are explained in the Medicare Benefit Policy Manual, Publication 100- 02, Chapter 11.  ESAs and their administration supplies and staff  are included in the payment for the ESRD PPS effective January 1, 2011.  Providers must continue to report ESAs on the claim.  ESAs are eligible for  outlier payment consideration.  The Medicare allowed payment (MAP) amounts for the  outlier policy include the ESA rate provided on the Average Sale Price (ASP) list.   60.4.1 - ESA Claims Monitoring Policy  (Rev. 10640, Issued:08- 06-21, Effective:09- 07-21, Implementation:09- 07-21)  Effective for services provided on or after April 1, 2006, Medicare has implemented a national claims monitoring policy for ESAs administered in Medicare renal dialysis facilities. This policy does not apply to claims for ESAs for patients who receive their dialysis at home and self -administer their ESA.   While Medicare is not changing its coverage policy on erythropoietin use to maintain a target hematocrit level between 30% and 36%, we believe the variability in response to ESAs warrants postponing requiring monitoring until the hematocrit reaches higher levels .  For dates of services April 1, 2006, and later, the Centers for Medicare & Medicaid Services (CMS) claims monitoring policy applies when the hematocrit level exceeds 39.0% or the hemoglobin level exceeds 13.0g/dL.  This does not preclude the contractors  from performing medical review at lower levels.   Effective for services provided on or after April 1, 2006, for claims reporting hematocrit or hemoglobin levels exceeding the monitoring threshold, the dose shall be reduced by 25% over the preceding month.  Providers may report that a dose reduction did occur in response to the reported elevated hematocrit or hemoglobin level by adding a GS modifier on the claim.  The definition of the GS modifier is defined as: Dosage of ESA has been reduced and maintaine d in response to hematocrit or hemoglobin level.  Thus, for claims reporting a hematocrit level or hemoglobin level exceeding the monitoring threshold without the GS modifier, CMS will reduce the covered dosage reported on the claim by 25%.  The excess do sage is considered to be not reasonable and necessary.  Providers are reminded that the patients medical records should reflect hematocrit/hemoglobin levels and any dosage reduction reported on the claim during the same time period for which the claim is submitted.   Effective for dates of service provided on and after January 1, 2008, requests for payments or claims for ESAs for ESRD patients receiving dialysis in renal dialysis facilities reporting a hematocrit level exceeding 39.0% (or hemoglobin exceedi ng 13.0g/dL) shall also include modifier ED or EE.  Claims reporting neither modifier or both modifiers will be returned to the provider for correction.  The definition of modifier ED is The hematocrit level has exceeded 39.0% (or hemoglobin 1evel has exc eeded 13.0g/dL) 3 or more consecutive billing cycles immediately prior to and including the current billing cycle.  The definition of modifier EE is The hematocrit level has exceeded 39.0% (or hemoglobin level has exceeded 13.0g/dL) less than 3 consecuti ve billing cycles immediately prior to and including the current billing cycle.  The GS modifier continues to be defined as stated above.  Providers may continue to report the GS modifier when the reported hematocrit or hemoglobin levels exceed the monitoring threshold for less than 3 months and a dose reduction has occurred.  When both modifiers GS and EE are included, no reduction in the covered dose will occur.  Claims reporting a hematocrit or hemoglobin level exceeding the monitoring threshold and the  ED modifier shall have an automatic 50% reduction in the covered dose applied, even if the claim also reports the GS modifier.  Below is a chart illustrating the resultant claim actions under all possible reporting scenarios:   Hct Exceeds 39.0% or  Hgb Exceeds 13.0g/dL  ED Modifier?  (Hct >39% or Hgb >13g/dL 3 cycles)  EE Modifier?  (Hct >39% or Hgb >13g/dL <3 cycles)  GS Modifier?  (Dosage reduced and maintained)  Claim Action  No N/A N/A N/A Do not reduce reported dose.  Yes No No No Return to provider for correction. Claim must report either modifier ED or EE.  Yes No No Yes Return to provider for correction. Claim must report either modifier ED or EE.  Yes No Yes Yes Do not reduce reported dose.  Yes No Yes No Reduce reported dose 25%.  Yes Yes No Yes Reduce reported dose 50%.  Hct Exceeds 39.0% or  Hgb Exceeds 13.0g/dL  ED Modifier?  (Hct >39% or Hgb >13g/dL 3 cycles)  EE Modifier?  (Hct >39% or Hgb >13g/dL <3 cycles)  GS Modifier?  (Dosage reduced and maintained)  Claim Action  Yes Yes No No Reduce reported dose 50%.   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.