FIRST COAST SERVICE OPTIONS
LOCAL COVERAGE DETERMINATION
CODING GUIDELINES


Contractor’s Determination Number

AJ0881

Contractor Name

First Coast Service Options, Inc.

Contractor Number

09101 – Florida
09201 – Puerto Rico/Virgin Islands

LCD Title

Erythropoietin Stimulating Agents

Coding Guidelines

J0881 and J0885 are intended for use for patients who are Non-ESRD and are not yet on dialysis. J0881 and J0885 are also intended for use with patients who meet the other indications outlined in the LCD.

J0882 and J0886 are intended for use only with patients who are ESRD and on dialysis.

Patients with ESRD receiving administrations of ESAs for the treatment of anemia may receive intravenous or subcutaneous administrations of the ESAs. Effective for claims submitted on or after 2/1/2007 with dates of service on or after 1/1/2007, all providers billing for injections of ESAs for ESRD beneficiaries are encouraged to include the modifier JA on the claim to indicate an IV administration or modifier JB to indicate a subcutaneous administration. All providers will be required to include route of administration modifiers at a future date.

Per Change Request 5699 the following requirements are effective on 1/1/2008:

Effective 1/1/2008 all claims billing for the administration of an ESA (HCPCS J0881, J0882, J0885, J0886 and Q4081) must report the most recent hematocrit or hemoglobin reading.

Effective 1/1/2008 all non-ESRD claims reporting J0881 or J0885 must begin reporting one of the following modifiers:

·         EA: ESA, anemia, chemo induced (ICD-9-CM codes identified in List 2 for J0881 and J0885)

·         EB: ESA anemia, radio-induced

·         EC: ESA anemia, non-chemo/radio (ICD-9-CM codes identified in List 1 for J0881 and J0885)

Claims that do not report either a Hgb or Hct and one of the three ESA modifiers will be returned to the provider. ESAs administered for more than one of the indicated therapies are billed as separate line items. Only one of the three ESA modifiers may be reported at the line item level.

A complete discussion of the Hgb and Hct Reporting requirements can be found in CMS manual System, Pub 100-04, Medicare Claims Processing, Chapter 17, Sections 80.8, 80.9 and 80.10, Change Request 5699, Transmittal 1413, dated January 11, 2008.

For reporting requirements related to the National Coverage Decision for ESA use in Cancer and related conditions, please refer to Change Request 5818, transmittals 80 and 1413. The following is a summary of reporting requirements:

Effective for DOS on or after 1/1/2008, non-ESRD ESA claims that report the ESA modifier EC (ESA, anemia, non-chemo/radio and one of the following ICD-9 codes will be denied:

·         Any anemia in cancer or cancer treatment patients due to folate deficiency 281.2,

·         B-12 deficiency 281.1, 281.3,

·         Iron deficiency 280.0-280.9,

·         hemolysis 282.0, 282.2, 282.9, 283.0, 283.10, 283.19, 283.2, 283.9,

·         bleeding 280.0, 285.1,

·         anemia associated with the treatment of acute and chronic myelogenous leukemias (CML, AML) 205.00-205.21, 205.80-205.91, and

·         erythroid cancers (207.00-207.81)

*Please note the above are nationally non-covered indications as outlined in the National Coverage Decision on ESAs in cancer and cancer related conditions

Effective for DOS on or after 1/1/2008, non-ESRD ESA claims that report the ESA modifier EC (ESA, anemia, non-chemo/radio and one of the following conditions will be denied:

·         Any anemia in cancer or cancer treatments patients due to bone marrow fibrosis

·         Anemia of cancer not related to cancer treatment

·         Prophylactic use to prevent chemotherapy-induced anemia

·         Prophylactic use to reduce tumor hypoxia

·         Patients with erythropoietin-type resistance due to neutralizing antibodies

·         Anemia due to cancer treatments if patients have uncontrolled hypertension

*Please note the above are nationally non-covered indications as outlined in the National Coverage Decision on ESAs in cancer and cancer related conditions. Because no specific ICD-9-CM codes exist for the indications listed out in the above group, this contactor will identify these non-covered conditions with ICD-9-CM code V49.89 when submitted on claims billing J0881 or J0885 and the EC modifier. This will indicate that the ESA was given for a nationally non-covered condition identified in business requirement 5818.1.1 for Change Request 5818.

Effective for DOS on or after 1/1/2008, non-ESRD ESA claims that report HCPCS J0881 and J0885 billed with ESA modifier EB (ESA, anemia, radio-induced) will be denied.

Effective for DOS on or after 1/1/2008, non-ESRD ESA claims for HCPCS J0881 and J0885 billed with modifier EA (ESA, anemia, chemo-induced) for anemia secondary to myelosuppressive anticancer chemotherapy in solid tumors, multiple myeloma, lymphoma, and lymphocytic leukemia will be denied when the reported Hemoglobin is > 10.0g/dL or the Hematocrit reported is > 30.0%, whether the patient is in the initiation phase or maintenance phase of treatment. Also, ESA treatment duration for each course of chemotherapy includes the 8 weeks following the final dose of myelosuppressive chemotherapy in a chemotherapy regime.

A complete discussion of the National Coverage Decision can be found in CMS Manual System, Pub 100-03, Chapter 1, Section 110.21 and CMS annual System, Pub 100-04, Medicare Claims Processing Manual, Chapter 17, Section 80.12.The related Change Request for this NCD is Transmittals 80 and 1412, Change Request 5818, dated January 14, 2008.

All claims not meeting medical necessity guidelines in this LCD should have the service billed with modifier -GA or -GZ.

The –GA modifier should be used when physicians, practitioners, or suppliers want to indicate that they expect that Medicare will deny a service as not reasonable and necessary and they do have an ABN signed by the beneficiary on file. A Medicare Advanced ‎Beneficiary Notice (ABN), Form CMS-R-131, should be signed by the beneficiary to indicate that ‎he/she accepts responsibility for payment.

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 Advance Beneficiary Notification (ABN) signed by the beneficiary.

If the service is statutorily non-covered, or without benefit category, submit the ‎appropriate CPT/HCPCS code with the -GY modifier. An ABN should not be used. A waiver such as the Notice of Exclusions from Medicare Benefits (NEMB) Form CMS-20007 may be used. The NEMB Form CMS-20007 is available online at http://www.cms.hhs.gov/medicare/bni/ or http://www.cms.hhs.gov/CMSForms/CMSForms/list.asp.

Chronic Renal Failure Patients (ESRD on dialysis and ESRD not on dialysis)

For the purpose of this LCD, the term “not on dialysis” refers to patients that are not on a regular course of maintenance dialysis. For patients who need occasional “rescue dialysis”, it would be appropriate to bill J0881 or J0885, since these patients are not on a regular course of maintenance dialysis.

For patients with ESRD who are on dialysis, a diagnosis of 285.21 and a diagnosis of 585.6 must be billed with procedure code J0882 or J0886/Q4081.

For patients with ESRD who are not on dialysis, a diagnosis code of 285.21 and a diagnosis of 403.01, 403.11, 403.91, 404.02, 404.03, 404.12, 404.13, 404.92, 404.93, 585.1, 585.2, 585.3, 585.4, 585.5 or 585.9, must be billed with procedure code J0881 or J0885 The EC modifier is also required.

Additional information for J0885:

*285.29 or *285.9 and one of the following must be billed together: 042, 070.54, 070.70, V07.8 or 714.0. The EC modifier is also required

A course of chemotherapy includes the eight (8) weeks following the last dose of chemotherapy for that course.

For J0882 and J0886/Q4081: Renal dialysis facilities (72X) and hospitals (13X and 85X) should report a diagnosis code of 585.6 for submission of claims.

Additional information for J0882, J0886/Q4081

For J0882 and J0886/Q4801, effective for dates of service on or after 1/1/06, the definition of Value code 48 and 49 will now reflect the most recent Hct or Hgb level taken before the start of the current billing period.

Effective for dates of service 4/1/06, on claims with 72X type of bill, when Value code 49 is greater than 39.0 (or Value code 48 is greater than 13.0), Modifier GS should be reported with procedure codes J0882 or J0886. Modifier GS indicates that the dosage of Epoetin alfa or Darbepoetin alfa has been reduced by 25% from the preceding months dosage. When modifier GS is not present, Medicare shall apply a 25% reduction in the reported dosage. Effective for dates of service on or after 10/1/2006, the GS modifier definition is revised to read “Dosage of Epoetin alfa or Darbepoetin alfa had been reduced and maintained in response to Hct or Hgb level”. Further discussion of this requirement can be found in Change Request 4135, National Monitoring Policy for Epo and Aranesp for ESRD patients treated in Renal Dialysis Facilities www.cms.hhs.gov

Effective for dates of service on or after 4/1/2006, for claims processed on or after 1/2/2007, providers submitting 72X TOB claims for patients who have opted out to receive home dialysis under Method I and are self administering the ESA in their home are exempt from the policy outlined in CR 4135 (National Monitoring Policy for Epo and Aranesp) and therefore, are not subject to automatic monitoring or automatic 25% payment reduction as described in CR 4135 and 5251. Providers should report condition code 70 on claims to identify home dialysis patients who self-administer ESAs and condition code 76 for the home dialysis patient who receives back-up services in the facility.

Effective for dates of service on or after 1/1/2008, requests for payment or claims for ESAs for ESRD patients receiving dialysis in renal dialysis facilities and reporting a hematocrit level exceeding 39.0% or a hemoglobin level exceeding 13.0g/dL for three or more consecutive billing cycles immediately prior to and including the current billing cycle, the dosage payable will be reduced by 50%, based on the reported dose. In addition, claims must report modifiers ED or EE for hematocrit levels exceeding 39.0% or hemoglobin levels exceeding 13.0 g/dL. Providers may continue to report the GS modifier when reported hematocrit or hemoglobin levels exceed the monitoring threshold and a dose reduction has occurred. When the GS modifier is included on claims reporting modifier EE, the claim will be paid in full. The GS modifier, however, will have no effect on the 50% dosage reduction, or claims reporting the ED modifier. Claims must include either the ED or EE modifier if hematocrit level exceeds 39.0% or hemoglobin level exceeds 13.0g/dL. Claims with neither modifier or with both modifiers will be returned to providers for correction. As intended in CRs 4135 and further clarified in CR 5251, this policy does not apply to ESA claims for ESRD patients who receive their dialysis at home or self-administer their ESA.  Please refer to Change Request 5700 for a complete discussion on the above requirements.

Modifier definitions:

ED: Hematocrit greater than 39.0% or hemoglobin greater than 13.0 g/dL for three or more consecutive billing cycles immediately prior to and including the current billing cycle. 

EE: Hematocrit greater than 39.0% or hemoglobin greater than 13.0 g/dL for less than 3 consecutive billing cycles immediately prior to and including the current billing cycle.

GS: Dosage of EPO or Darbepoetin alfa has been reduced and maintained in response to hematocrit or hemoglobin level.

Effective for dates of service on or after 1/1/08, renal dialysis facilities (72X) will bill for each administration of Epo (Q4081) on a separate line indicating the line item date of service for the administration.

Discarded ESAs for Method I Dialysis patients

Multiuse vials are not subject to payment for discarded amounts of drug or biological, with the exception of self-administered ESAs by Method I home dialysis patients. Effective 12/1/2008, the renal facility must bill the program using the modifier JW for the amount of ESAs appropriately discarded if the home dialysis patient must discard a portion of the ESA supply due to expiration of a via, because of interruption in the patient’s plan of care, or unused ESAs on hand after a patient’s death. This applies only to home dialysis patients who meet the Method I conditions described in Pub –100-02, Medicare Benefit Policy Manual, Chapter 11, section 90, and does not apply to Method II home dialysis patients. When billing for drug wastage in accordance with the drug wastage policy in Pub 100-4, Chapter 17, Section 40.1, the provider must show the wastage on a separate line item with modifier JW. The line item date of service must be the date of the last covered administration according to the plane of care or if the patient dies use the date of death. These instructions are effective for dates of services on or after 12/1/2008 in accordance with Change Request 6133, dated August 29, 2008. A complete discussion can be found in the above-mentioned manual references in addition to Pub 100-04, Chapter 17, Section 60.4.4.1 and 60.7.4.

Effective 10/01/2008 revenue code 045x will no longer be required in order to allow for EPO or Aranesp payment related to an unscheduled or emergency dialysis treatment.  Payment will only be made for ESRD related EPO or Aranesp (Q4081 or J0882) in the outpatient hospital setting (13x or 85x) when HCPCS code G0257 appears on the claim for dates of service on or after 10/01/2008.

Other Comments

N/A

Revision History

Date

Revision

06/30/2009

1 - Revision to update coding requirements for J0881 and J0885.  The effective date of this revision is based on date of service.

02/16/2009 – Florida
03/02/2009 – Puerto Rico/Virgin Islands

Original


Document formatted: 04/15/2009 (SS/st)