Billing and Coding: Erythropoiesis Stimulating Agents (ESA)

This article gives guidance for billing, coding, and other guidelines in relation to local coverage policy DL34356- Erythropoiesis Stimulating Agents (ESA) . General Guidelines for Claims submitted to Part A or Part B MAC: Procedure codes may be subject to National Correct Coding Initiative (NCCI) edits or OPPS packaging edits. Refer to NCCI and OPPS requirements prior to billing Medicare. For services requiring a referring/ordering physician, the name and NPI of the referring/ordering physician must be reported on the claim. A claim submitted without a valid ICD-10-CM diagnosis code will be returned to the provider as an incomplete claim under Section 1833(e) of the Social Security Act. The diagnosis code(s) must best describe the patient's condition for which the service was performed. For diagnostic tests, report the result of the test if known; otherwise the symptoms prompting the performance of the test should be reported. 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. Effective January 1, 2008, the following claims must report the most recent hematocrit or hemoglobin reading: All claims billing for the administration of an ESA (HCPCS J0881, J0882, J0885, J0886, Q4081, Q5105, and Q5106). For institutional claims the hemoglobin reading is reported with a value code 48 and a hematocrit reading is reported with the value code 49. Claims not reporting a value code 48 or 49 will be returned to the provider. 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 hemoglobin or hematocrit readings in Loop 2400 MEA segment. The specifics are mEA01=TR (for test results), MEA02=R1 (for hemoglobin) orR2 (for hematocrit), and MEA03= the test results. For dates of service on or after January 1, 2007, all providers are encouraged to include route of administration modifiers, JA for intravenous administration and JB for subcutaneous administration, on claims billing Q4081, Q5105, J0882 for ESRD beneficiaries. (CMS Publication 100-04, Medicare Claims Processing Manual, Transmittal No. 1212, Change Request #5480, March 30, 2007, 2005, Requirement for providing route of administration codes for Erythropoiesis stimulating agents.) Advance Beneficiary Notice of Non-coverage (ABN) Modifier Guidelines An ABN may be used for services which are likely to be non-covered, whether for medical necessity or for other reasons. Refer to CMS Publication 100-04, Medicare Claims Processing Manual, Chapter 30, for complete instructions. Effective from April 1, 2010, non-covered services should be billed with modifier –GA, -GX, -GY, or –GZ, as appropriate. The –GA modifier (“Waiver of Liability Statement Issued as Required by Payer Policy”) should be used when physicians, practitioners, or suppliers want to indicate that they anticipate that Medicare will deny a specific service as not reasonable and necessary and they do have an ABN signed by the beneficiary on file. Modifier GA applies only when services will be denied under reasonable and necessary provisions, sections 1862(a)(1), 1862(a)(9), 1879(e), or 1879(g) of the Social Security Act. Effective April 1, 2010, Part A MAC systems will automatically deny services billed with modifier GA. An ABN, Form CMS-R-131, should be signed by the beneficiary to indicate that ‎he/she accepts responsibility for payment.‎ The -GA modifier may also be used on assigned claims when a patient refuses to sign the ABN and the latter is properly witnessed. For claims submitted to the Part A MAC, occurrence code 32 and the date of the ABN is required. Modifier GX (“Notice of Liability Issued, Voluntary Under Payer Policy”) should be used when the beneficiary has signed an ABN, and a denial is anticipated based on provisions other than medical necessity, such as statutory exclusions of coverage or technical issues. An ABN is not required for these denials, but if non-covered services are reported with modifier GX, will automatically be denied services. The –GZ modifier should be used when physicians, practitioners, or suppliers want to indicate that they expect that Medicare will deny an item or service as not reasonable and necessary and they have not had an ABN signed by the beneficiary. ‎If the service is statutorily non-covered, or without a benefit category, submit the ‎appropriate CPT/HCPCS code with the -GY modifier. An ABN is not required for these denials, and the limitation of liability does not apply for beneficiaries. Services with modifier GY will automatically deny. Documentation Requirements The patient’s medical record should include but is not limited to: The assessment of the patient by the ordering provider as it relates to the complaint of the patient for that visit, Relevant medical history Results of pertinent tests/procedures Signed and dated office visit record/operative report (Please note that all services ordered or rendered to Medicare beneficiaries must be signed.) Effective February 23, 2013, Omontys ® (HCPCS code J0890) has been recalled by the FDA and will no longer be covered by CGS. The effective date of this non-coverage is February 23, 2013. More information regarding this recall is available on the FDA website. Other Comments: Bill type codes for Home Health services are not listed in the LCD for Erythropoiesis Stimulating Agents (ESAs) because " drugs and biologicals are specifically excluded from coverage by the statute section 1861(m)(5) of the Act.” The administration of an ESA may be a qualifying service for Home Health services. The beneficiary must be receiving the ESA for a covered indication, as specified in this LCD. For claims submitted to the Part A MAC: This coverage determination also applies within states outside the primary geographic jurisdiction with facilities that have nominated CGS Administrators, LLC to process their claims. Bill type codes only apply to providers who bill these services to the Part A MAC. Bill type codes do not apply to physicians, other professionals and suppliers who bill these services to the carrier or Part B MAC. For dates of service prior to April 1, 2010, FQHC services should be reported with bill type 73x. For dates of service on or after April 1, 2010, bill type 77x should be used to report FQHC services. Limitation of liability and refund requirements apply when denials are likely, whether based on medical necessity or other coverage reasons. The provider/supplier must notify the beneficiary in writing, prior to rendering the service, if the provider/supplier is aware that the test, item or procedure may not be covered by Medicare. The limitation of liability and refund requirements do not apply when the test, item or procedure is statutorily excluded, has no Medicare benefit category or is rendered for screening purposes. The patient's medical record must contain documentation that fully supports the medical necessity for services included within this LCD. (See "Indications and Limitations of Coverage.") This documentation includes, but is not limited to, relevant medical history, physical examination, and results of pertinent diagnostic tests or procedures. Listing of ICD-9-CM codes contained in this LCD does not assure coverage of the specific service. Coverage criteria specified in this LCD shall be applied to determine appropriate reimbursement. Medical record documentation must be legible, maintained in the patient’s medical record, and meet the criteria contained in this LCD. Medical records such as physician’s (or non-physician practitioner's) order must be made available upon request of CGS. Documentation the provider is to maintain in the patient’s medical record includes: patient’s weight in kilograms, ESA units administered per kilogram of body weight, and medical justification for administration of ESAs exceeding usual doses. Documentation supporting the indication for ESA administration must be made available upon the request of CGS; for all patients, this includes Hgb/Hct and documentation of adequate iron stores. Additional information is determined by indication. Regular reporting of Hgb/Hct is needed to show monitoring of ESA dose. Dialysis Patients Documentation must include dialysis schedule, Hgb/Hct immediately prior to billing period. For ESRD patients on home dialysis, the following additional information must be maintained in the medical record and available to CGS upon request: a care plan, evidence of home monitoring (including a record of the ESA supplied to the patient and a record of dose administered), patient instructions and patient selection protocol. Non-dialysis Patients For chronic kidney disease (CKD) patients: documentation must include serum creatinine, creatinine clearance, or GFR. Patients with myelodysplastic syndrome: bone marrow biopsy report*, date of initiation of ESA therapy, and response to ESA administration (change in Hgb/Hct and/or transfusion requirements). *For patients on ESA therapy for MDS, initiated prior to 12/01/2007, CGS Administrators, LLC requires that a physician’s statement that the patient does have MDS be included in the medical record. For ESA therapy initiated on or after 12/01/2007, a copy of the actual bone marrow report must be included in the medical record. MDS cannot be diagnosed definitively without a bone marrow biopsy. Not Applicable Literature describes a significant increase in risk associated with Hct greater than 36 %. Prompt and judicious dose adjustments are anticipated in response to reaching the target Hgb or Hct (delayed reductions or reductions of less than 25% must be justified in the medical record). The medical record must support the necessity of a target Hgb greater than 12 g/dL or Hct greater than 36 %.