Billing and Coding: Erythropoiesis Stimulating Agents (ESAs)

CMS Pub 100-04 Medicare Claim Processing Manual, Chapter 8- Outpatient ESRD Hospital, Independent Facility, and Physician/Supplier Claims, Section 60.4.2 - Facility Billing Requirements for ESAs

CMS Publication 100-04 Medicare Claims Processing Manual, Chapter 17 - Drugs and Biologicals, Section 80.9 – Required Modifiers for ESAs Administered to Non-ESRD patients

CR 11244: Discontinuing the Erythropoietin Stimulating Agent (ESA) Monitoring Policy System Edits under the End Stage Renal Dialysis Prospective Payment System (ESRD PPS). Effective 01/01/2020.

The billing and coding information in this article is dependent on the coverage indications, limitations and/or medical necessity described in the associated LCD L34633.

A number of chronic conditions, especially chronic renal failure, result in decreased production of or relative resistance to erythropoietin, often causing anemia. Supplementation by synthetic drugs with structures identical or similar to naturally occurring erythropoietin has been proven safe and effective in correcting anemia in certain groups of patients.

CMS Pub 100-04 Medicare Claim Processing Manual, Chapter 8- Outpatient ESRD Hospital, Independent Facility, and Physician/Supplier Claims, Section 60.4.2 - Facility Billing Requirements for ESAs (Rev. 4105, Issued: 08-03-18, Effective: 01-01-19, Implementation:01-07-19)
Effective January 1, 2012, ESRD facilities are required to report hematocrit or hemoglobin levels on all ESRD claims. Reporting the value 99.99 is not permitted when billing for an ESA.

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.

Patients with end stage renal disease (ESRD) receiving administrations of erythropoiesis stimulating agents (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 facilities claim 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 dialysate by appending the modifier JE (administered via dialysate).

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.

CMS Pub 100-04 Medicare Claim Processing Manual, Chapter 8- Outpatient ESRD Hospital, Independent Facility, and Physician/Supplier Claims, Section 60.4.3.1 – Other Information Required on the Form CMS-1500 for Epoetin Alfa (EPO) (Rev. 2582, Issued: 11-02-12, Effective: 04-01-13, Implementation: 04-01-13)
Note: Effective January 1, 2011 Method II and Supplier billing for ESRD related items and services is no longer applicable. The Medicare improvements for Patients and providers Act (MIPPA) section 153b requires that all payments related to the treatment of ESRD be paid to the ESRD facility treating the patient.
The following information is required for EPO.
A. Diagnoses - The diagnoses must be submitted according to ICD-9-CM and correlated to the procedure. This information is in Item 21, of the Form CMS-1500.
B. Hematocrit (HCT)/Hemoglobin (Hgb) - There are special HCPCS codes for reporting the injection of EPO for claims with dates of service prior to January 1, 2004. These allow the simultaneous reporting of the patient’s latest HCT or Hgb reading before administration of EPO.
C. Units Administered - The standard unit of EPO is 1,000. The number of 1,000 units administered per line item is included on the claim.
NOTE: Creatinine and weight identified below are required on EPO claims as applicable.
D. Date of the Patient’s most recent HCT or Hgb.
E. Most recent HCT or Hgb level - (prior to initiation of EPO therapy).
F. Date of most recent HCT or Hgb level - (prior to initiation of EPO therapy).
G. Patient’s most recent serum creatinine - (within the last month, prior to initiation of EPO therapy).
H. Date of most recent serum creatinine - (prior to initiation of EPO therapy).
I. Patient’s weight in kilograms.
J. Patient’s starting dose per kilogram - (The usual starting dose is 50-100 units per kilogram.).

CMS Pub 100-04 Medicare Claim Processing Manual, Chapter 8- Outpatient ESRD Hospital, Independent Facility, and Physician/Supplier Claims, Section 60.4.6.1 - Other Information Required on the Form CMS-1500 for Darbepoetin Alfa (Aranesp) (Rev.3053, Issued: 08-28-14, Effective: ICD-10: Upon Implementation of ICD-10; ASC X12: 01-01, 12, Implementation ICD-10: Upon Implementation of ICD-10’ ASC X12: 09-30-14) (Rev.2582, Issued: 11-02-12, Effective: 04-01-13, Implementation: 04-01-13)
Note: Effective January 1, 2011 Method II and Supplier billing for ESRD related items and services is no longer applicable. The Medicare Improvements for Patients and Providers Act (MIPPA) section 153b requires that all payments related to the treatment of ESRD be paid to the ESRD facility treating the patient.
The following information is required for Aranesp.
A. Diagnoses - The diagnoses must be submitted according to ICD coding guidelines, must use the proper version of ICD for the service date, and must be correlated to the procedure. This information is in Item 21 of the Form 1500.
B. Date of the Patient’s most recent HCT.
C. Most recent HCT (prior to initiation of Aranesp therapy).
D. Date of most recent HCT (prior to initiation of Aranesp therapy).
F. Patient’s most recent serum creatinine - (within the last month, prior to initiation of Aranesp therapy).
G. Date of most recent serum creatinine - (prior to initiation of Aranesp therapy).
H. Patient’s weight in kilograms.
I. Patient’s starting dose per kilogram.

Contractor Coding Instructions

1. 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 must include documentation that the initially administered ESA met coverage criteria, as set forth in the Coverage Indications, Limitations and/or Medical Necessity section of L34633. The patient’s medical records with history and previous work-up, including lab work at another site, should support the continuation of this drug. The current work-up should include testing to support the need to continue the drug. Initial information must be available for all claims for post-payment review. If the patient has had transfusion(s) or another exception the physician’s summary shall include the reasoning why the patient's lab values differ.

2. When billing for the administration of an ESA, use the applicable therapeutic injection codes only. CPT code 99211 is not acceptable if the only service is the injection. If a brief E/M service is provided bill 99211 with the drug code but do not bill the therapeutic injection codes with code 99211.

3. If an electronic submitter has additional documentation, which Medicare may require, they can indicate:

   style="margin: 0 0 0 40px; border: none; padding: 0px;">“DOCUMENTATION AVAILABLE UPON REQUEST” in the narrative (NTE02) segment. If the additional documentation is needed for Medicare to make its payment determination, a development letter will be sent requesting the information. If the NTE02 segment does not indicate the availability of the additional documentation or the information is not returned in a timely manner, the claim will be returned as unprocessable.

4. The following information must be submitted with each claim:

   1. Effective January 1, 2012, ESRD facilities are required to report hematocrit or hemoglobin levels on all ESRD claims. Reporting the value 99.99 is not permitted when billing for an ESA.
   2. 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.

Utilization Guidelines
CMS Publication 100-04, Medicare Claims Processing Manual, Chapter 8 -Outpatient ESRD Hospital, Independent Facility, and Physician/Supplier Claims, Sections 60.4.1 – ESA Claims Monitoring Policy and 60.4.2 – Facility Billing Requirements for ESAs. 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. 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.

CMS Publication 100-04, Medicare Claims Processing Manual, Chapter 8 - Outpatient ESRD Hospital, Independent Facility, and Physician/Supplier Claims, Sections 60.4.1- ESA Claims Monitoring Policy and 60.4.2 – Facility Billing Requirements for ESAs. Medically Unlikely Edits (MUE) For dates of service on and after January 1, 2008, the MUE for claims billing for Aranesp® is reduced to 1200 mcg from 1500 mcg. Darbepoetin alfa is given not more than once per week according to its Food and Drug Administration approved labeling. Maximum Allowable Administrations The maximum number of administrations of Aranesp for a billing cycle is 5 times in 30 / 31 days.