Billing and Coding: Erythropoiesis Stimulating Agents (ESAs)

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.

**General Information for Erythropoiesis Stimulating Agents (ESA) claims:**

  * No ESA should be given within the context of uncontrolled hypertension.
  * No ESA should be used to replace red blood cell (RBC) transfusions in patients who need immediate urgent correction of anemia.
  * With any ESA, the patient's medical record should reflect the clinical reason for dose changes and hematocrit (HCT) levels outside the range of 30.0-36.0% (hemoglobin (Hb) 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.
  * There may be instances when a patient has a chronic health condition not specifically addressed in this policy for which an ESA is useful treatment. Such scenarios would be expected to demonstrate considerable transfusion dependence and anemia-related symptoms. In the event of denials, an appeals process will allow the opportunity for the provider to substantiate a reasonable and necessary basis for ESA treatment based on medical literature, specialty organization best practice alignment, and the unique clinical circumstances for the beneficiary. Explanatory documentation within the medical record is crucial.

**Coding Guidance**

For coverage of all drugs and biologicals, such as erythropoiesis stimulating
agents (ESAs), used for the treatment of ESRD, please refer to CMS IOM
Publication 100-02, _Medicare Benefit Policy Manual_ , Chapter 11, Section
20.3.

**HCPCS Drug Codes:**  
Healthcare Common Procedure Coding System (HCPCS) codes J0881, J0885, J0888,
and Q5106 are for use in patients with non-end stage renal disease (ESRD)
conditions.

HCPCS codes J0882, J0887, Q4081, and Q5105 are intended for use only with
patients who have ESRD and are on dialysis.

**Modifiers:**

**-EA, EB, EC**

Effective January 1, 2008, all non-ESRD claims billing HCPCS Q5106, J0881 and
J0885 must begin reporting one of the following modifiers:

  * EA: ESA, anemia, chemo-induced;
  * EB: ESA, anemia, radio-induced;
  * EC: ESA, anemia, non-chemo/radio.

**-JA, JB, JE**  
Route of administration is important information especially with drugs that
can be given multiple different ways. All non-ESRD claims reporting HCPCS code
J0881, J0885, J0888, or Q5106 and all ESRD claims reporting J0882, Q4081, and
Q5105 must also be reported with one and only one of the following modifiers:

  * JA-Administered intravenously
  * JB-Administered subcutaneously
  * JE-Administered via dialysate

**Claims Reporting-Hemoglobin/Hematocrit**

Claims billing for the administration of an ESA (HCPCS codes J0881, J0882,
J0885, J0887, J0888, Q4081, Q5105 and Q5106) must report the most recent HCT
or Hb reading. Claims not reporting this information will be returned to the
provider.

For institutional claims the Hb reading is reported with a value code 48 and a
HCT reading is reported with the value code 49.

For professional paper claims, test results are reported in item 19 of the
Form CMS-1500 claim form. For electronic claims (837P), providers report the
Hb or Hct readings in Loop 2400 MEA segment. The specifics are mEA01=TR (for
test results), MEA02=R1 (for Hb) orR2 (for HCT), and MEA03= the test results.

**Documentation Requirements**

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.