Darbepoetin Alfa, Non-ESRD - CA Service Specific Post-Payment Final Findings

CMS is required by the Social Security Act to ensure that payment is made only for those medical services that are reasonable and necessary. Noridian's priority is to minimize potential future losses to the Medicare Trust Fund by preventing inappropriate Medicare payments.  This is accomplished through provider education, training, and the medical review of claims. A post-payment review has been initiated based on data analysis.

This is to update providers of the claim review findings and closure of the file of Healthcare Common Procedure Coding System (HCPCS) code J0881 for CA.

Summary of Findings

Since the initiation of the review, 147 claims were reviewed from May 10, 2021 through December 3, 2021 with an overall claim error rate of 55.8% and payment error rate of 74.8%. The breakdown of those findings are as follows:

  • 65 claims were accepted
  • 82 claims were denied in full for the following reasons:
    • Documentation did not support FDA approved diagnosis
    • No documentation received in response to Additional Documentation Request

If you are a provider that had claims involved in the review sample and disagree with a claim determination, the normal appeal process may be followed as directed on the Noridian website under Appeals or as directed in your claim remittance advice.


Paragraph Name Paragraph Details
Aranesp (Darbepeoetin Alfa) Per the Food and Drug Administration (FDA) label, Aranesp® is an erythropoiesis-stimulating agent (ESA) used to treat patients with two types of anemia. These include:
  • Anemia in patients with chronic kidney disease (CKD) that are on dialysis and patients not on dialysis; or
  • Patients with non-myeloid malignancies that have anemia due to myelosuppressive chemotherapy and there is a minimum of two additional months of planned chemotherapy
Documentation submitted for review should support an approved FDA label indication. The FDA label should be carefully reviewed to ensure the label requirements are met. If documentation does not support an FDA label indication the claim is denied as the use of the drug is considered off-label and is not covered by Medicare. Below are some limitations of use for Aranesp® per the FDA label, this is not an all-inclusive list.
  • Cancer patients receiving hormonal agents, biological products, or radiotherapy unless given simultaneously with myelosuppressive chemotherapy
  • Cancer patients receiving myelosuppressive chemotherapy for a cure
  • Not used as a substitute for blood transfusions in patients who require immediate treatment for anemia
For more information, refer to the National Coverage Determination (NCD) "National Coverage Determination (NCD) for Erythropoiesis Stimulating Agents (ESAs) in Cancer and Related Neoplastic Conditions 110.21" and Internet Only Manual (IOM), Medicare Benefit Policy Manual (MBPM), Chapter 15, Section 50.5.2-
Timely Submission of Documentation and 569PPs It is the responsibility of Medicare providers to submit all documentation requested on the additional documentation requests (ADR) within the allotted time frame. Noridian allows 45 calendar days for the medical records to be received per the ADR request for post-payment reviews. On day 46, if the medical records have not been received, the claim will be denied provider liable with reason code 569PP. If there is no documentation to complete the medical review (MR), services billed on the claim cannot be supported.

A redetermination request should be submitted to Noridian within 120 days from the date of the 569PP denial. Contractors shall reopen the claim for review as long as all conditions are met. The determination made on the reopening claim has the potential to reverse non-covered dollars.

For additional information, refer to Internet-only Manual Pub 100-08, Chapter 3, Section, 42 CFR 424.5(a)(6), and Social Security Act sections 1815(a), 1833(e) and 1862(a)(1)(A).


View references used in review. Further educational opportunities may be found under Education and Outreach. If you are in need of an individualized education training event, contact the POE Department at mac@noridian.com. If you need coding assistance, please check your CPT®, HCPCS, ICD-10 books and your specific association.

Provider Action Required

File results and trending errors are being shared with all providers to assess compliance and billing practices if the service is provided within your facility. If your facility had claim documentation requested for this review, please refer to the individual result letter you received. You can also access individual determinations for claims that were requested from your facility by reviewing comments in either DDE or on the Noridian Medicare Portal (NMP).

Further provider action recommended includes:

  • Provide education regarding errors noted to applicable staff members.
  • Verify documentation supports medical necessity of Healthcare Common Procedure Coding System (HCPCS) code J0881.
  • Summary

This service specific post-payment file is now closed for CA and Noridian will no longer request documentation for this review. Noridian will continue to monitor data analysis and perform medical review for medical necessity and appropriate coding practices.

If you have any other questions, contact the JE Provider Contact Center at 1-855-609-9960.


Last Updated Dec 09 , 2023