Article - Billing and Coding: Erythropoiesis Stimulating Agents (ESA) (A56462)

CMS National Coverage PolicyCMS Publication 100-04,Medicare Claims Processing Manual,Chapter 8, Outpatient ESRD Hospital, Independent Facility, and Physician/Supplier Claims for specific billing instructions for ESAs.CMS Publication 100-04,Medicare Claims Processing Manual,Chapter 30Article TextThis article gives guidance for billing, coding, and other guidelines in relation to local coverage policy L34356-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 GuidelinesAn 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 RequirementsThe patients 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 historyResults of pertinent tests/proceduresSigned 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.