Billing and Coding: Erythropoiesis Stimulating Agents (ESA)

This 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 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.