National Government Services Part B MR Department analyzes national and local data to identify possible improper payment for Medicare services. In an effort to reduce the Part B CERT error rate, the MR Department will be conducting a service specific post payment review of:

• • CPT code J0881 (injection, darbepoetin alfa, 1 microgram (non-ESRD use)

The primary focus of these audits will be to determine whether the medical necessity of the services billed is at the correct code per Medicare guidelines.

NGS has randomly selected claims billed for the services mentioned in J6 for Part B providers in the states of Illinois, Wisconsin and Minnesota.

If a claim is selected for review, the provider will receive an ADR letter. Providers with claims selected for review must submit the requested documentation within 45 days of the date of the ADR letter. Failure to submit the requested documentation in a timely manner may result in a denial of the billed services.

It is important to submit all documentation which supports the medical necessity of the mentioned services. The medical record must be legible and the name of the beneficiary, the date of service, and the signature of the billing provider clearly identified. Please ensure all documentation to support medical necessity of the billed service is submitted for review.

Documentation Requirements

• The medical record must be legible and the name of the beneficiary, the date of service, and the signature of the billing provider clearly identified.
• Documentation supporting the indication for ESA administration
• Physician’s orders
• Hemoglobin and hematocrit (Hgb/Hct) levels immediately prior to initiation of ESA treatment
• Hgb/Hct levels prior to administration of maintenance doses to monitor/adjust dosage
• Documentation of adequate iron stores
• Starting dose and ongoing dosage including weight in kilograms
• Units administered per kilogram of body weight,
• Medical justification for dosage exceeding usual doses
• Administration records.
• A copy of the bone marrow biopsy report is required if ESA is administered for myelodysplastic syndrome.
• Additional pertinent documentation may include:
  • medical history and physical examination notes,
  • blood transfusion records,
  • medication lists including chemotherapy treatment,
  • documentation regarding surgical interventions,
  • blood transfusion information and
  • results of additional diagnostic tests.

Related Content

• Social Security Act (SSA), Title XVIII – Health Insurance for the Aged and Disabled, Section 1862(a)(1)(A)- Exclusions from Coverage and Medicare as a Secondary Payer, Social Security Act Section 1862
• Social Security Act (SSA), Title XVIII – Health Insurance for the Aged and Disabled, Section 1833(e)- Payment of Benefits, Social Security Act Section 1833
• CMS.gov, Erythropoietin Stimulating Agents Policies | CMS
• Centers for Medicare & Medicaid Services (CMS) Internet Only Manual (IOM) Publication 100-02, Medicare Benefit Policy Manual, Chapter 1, Section 30 – Drugs and Biologicals
• CMS IOM Publication 100-02, Medicare Benefit Policy Manual, Chapter 6, Section 30 – Drugs and Biologicals
• CMS IOM Publication 100-02, Medicare Benefit Policy Manual, Chapter 7, Administration of Medications
• CMS IOM Publication 100-02, Medicare Benefit Policy Manual, Chapter 11, Sections:
  • 30.1 Frequency of Dialysis Sessions
  • 30.4 Drugs and Biologicals
  • 30.5 New ESRD Composite Payment Rates Effective 1/1/2005
  • 90 Epoetin (EPO)
• CMS IOM Publication 100-02, Medicare Benefit Policy Manual, Chapter 15, Sections:
  • 50 Drugs and Biologicals
  • 50.1 Definition of Drug or Biological
  • 50.2 Determining Self-Administration of Drug or Biological
  • 50.3 Incident-to Requirements
  • 50.4.1 Approved Use of Drug
  • 50.4.3 Examples of Not Reasonable and Necessary
  • 50.5.2 Erythropoietin (EPO)
  • 50.5.2.1 Requirements for Medicare Coverage for EPO [home use]
  • 50.5.2.2 Medicare Coverage of Epoetin Alfa (Procrit) for Preoperative Use
• CMS IOM Publication 100-03, Medicare National Coverage Determinations (NCD) Manual, Chapter 1, Part 2, Section 110.21 –,Erythropoiesis Stimulating Agents (ESAs) in Cancer and Related Neoplastic Conditions
• CMS IOM Publication 100-04, Medicare Claims Processing Manual, Chapter 17, Sections:
  • 80.8 Reporting of Hematocrit and/or Hemoglobin Levels
  • 80.9 Required Modifiers for ESAs Administered to Non-ESRD Patients
  • 80.10 Hospitals Billing for Epoetin Alfa (EPO) and Darbepoetin Alfa (Aranesp) for Non-ESRD Patients
  • 80.11 Requirement for Providing Route of Administration Codes for Erythropoiesis Stimulating Agents (ESAs)
  • 80.12 Claims Processing Rules for ESAs Administered to Cancer Patients for Anti-Anemia Therapy

Revised 5/5/2021
Posted 5/4/2021