evekhm/cms_iom_500 huggingface dataset:
(Medicare Claims Processing Manual)
60.2.1.1  Separately Billable ESRD Drugs  (Rev. 10640, Issued:08- 06-21, Effective:09- 07-21, Implementation:09- 07-21)   Effective January 1, 2011, section 153b of the MIPPA requires that all drugs and biologicals that are used in the treatment of ESRD be provided and billed by the ESRD  facility.  When a drug or biological is billed by providers other than the ESRD facility and the drug or biological furnished is designated as a drug or biological that is included in the ESRD PPS ( renal dialysis service), the claim will be rejected or denied.  In the event that a drug or biological generally used in the treatment of ESRD was furnished to an ESRD beneficiary for reasons other than for the treatment of ESRD, the provider may report the drug on the claim with modifier AY and receive separate payment.  For claims with dates of service on or after July 1, 2013, when these drugs are administered through the dialysate the provider must append the modifier JE (Administered via Dialysate).    All drugs reported on the renal dialysis facility claim are considered included in the ESRD PPS, unless they are covered by an exception as discussed below. The list of drugs and biologicals for consolidated billing are designated as always  ESRD -related an d therefore no separate payment  is made to ESRD facilities.  However, CMS has determined that some of these drugs warrant separate payment when they are used to treat conditions other than ESRD.    Exceptions to Always ESRD Related Drugs:  The following drugs have been approved for separate payment consideration when billed with the AY modifier attesting to the drug not being used for the treatment of ESRD.  The ESRD facility is required to indicate (in accordance with ICD coding guidelines) the diagnosis  code for which the drug is indicated.    Vancomycin, effective January 1, 2012   Daptomycin, effective January 1, 2013   Items and services subject to the consolidated billing requirements for the ESRD PPS can be found on the CMS website at:  http://www.cms.gov/ESRDPayment/50_Consolidated_Billing.asp#TopOfPage
(Medicare Claims Processing Manual)
Other drugs and biologicals  are separately payable to the dialysis facility if the drug was not used  for the tr eatment of ESRD.  The facility must include the modifier AY to indicate it was not for the treatment of ESRD.   Drugs are assigned HCPCS codes.  If no HCPCS code is listed for a drug (e.g., a new drug) the facility bills using HCPCS code J3490, Unclassifie d Drugs, and submits documentation identifying the drug. To establish a code for the drug, the A/B MAC (A) checks HCPCS to verify that there is no acceptable HCPCS code for billing and if a code is not found checks with the local A/B MAC (B), which may ha ve a code and price that is appropriate. If no code is found the drug is processed under HCPCS code J3490. See Chapter 17 for a complete description of drug pricing.   60.2.1.2  Facilities Billing for ESRD Drugs and Biologicals Equivalent to Injectable Dru gs (Rev. 10640, Issued:08- 06-21, Effective:09- 07-2021, Implementation:09- 07-21)
(Medicare Claims Processing Manual)
The ESRD PPS includes some  injectable  drugs and biologicals that have oral equivalent    These drugs should be reported on the renal dialysis facility claim for consideration o f outlier payments.  For the drugs and biologicals  used in the treatment of ESRD  that do not have an assigned HCPCS, effective for dates of services on or after January 1, 2011, ESRD facilities should bill using revenue code 0250 and report the national drug code (NDC).  The NDC is reported on the 837i claim transaction in loop 2410 line 03.  CMS will price these oral  drugs based on a plan comparison for consideration in the outlier payment.  CMS will maintain a list of these drug categories by NDC  and wi ll post  the list on the CMS.gov website .  Payment includes a  mean dispensing fee and this amount is updated via Recurring Update Notifications.  This amount  is applied to each NDC included on the monthly claim.  CMS limits 1 dispensing fee per NDC per mont h.  Providers should report the quantity in the smallest available unit.  This is necessary because Medicare is using the mean per unit cost in calculating the outlier.  For example, if the provider reports NDC 00054312041 Calcitriol 1 mcg/ml oral solution (15/ml/bottle) and uses the full 15 ml bottle, the quantity is reported as 15, not 1.  This allows for the most accurate calculation for the outlier policy .  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.
(Medicare Claims Processing Manual)
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
(Medicare Claims Processing Manual)
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.
(Medicare Claims Processing Manual)
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.
(Medicare Claims Processing Manual)
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.
(Medicare Claims Processing Manual)
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.
(Medicare Claims Processing Manual)
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%.
(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.
(Medicare Claims Processing Manual)
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.
(Medicare Claims Processing Manual)
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
(Medicare Claims Processing Manual)
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)