Article 4I-102AB ESA-Non-Dialysis

Article Title

Erythropoiesis Stimulating Agents (ESA) – Non-Dialysis

Contractor's Determination Number

4I-102AB

Contractor Name

TrailBlazer Health Enterprises

Contractor Number

· 04001 (04101, 04201, 04301, 04401, 04901).

· 04002 (04102, 04202, 04302, 04402).

Contractor Type

· MAC – Part A.

· MAC – Part B.

AMA CPT/ADA CDT Copyright Statement

CPT only copyright 2002-2011 American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association. Applicable FARS/DFARS Apply to Government Use. Fee schedules, relative value units, conversion factors and/or related components are not assigned by the AMA, are not part of CPT, and the AMA is not recommending their use. The AMA does not directly or indirectly practice medicine or dispense medical services. The AMA assumes no liability for data contained or not contained herein. The Code on Dental Procedures and Nomenclature (Code) is published in Current Dental Terminology (CDT). Copyright (c) American Dental Association. All rights reserved. CDT and CDT-2010 are trademarks of the American Dental Association.

Primary Geographic Jurisdiction

· CO.

· NM.

· OK.

· TX:

o Indian Health Service.

o End Stage Renal Disease (ESRD) facilities.

o Skilled Nursing Facilities (SNFs).

o Rural Health Clinics (RHCs).

· Transitioned WPS legacy providers.

Oversight Region

· Region IV.

· Region VI.

Original Article Effective Date

05/14/2012

Article Revision Effective Date

N/A

Article Revision Ending Date

N/A

Article Ending Effective Date

N/A

Article Text

Abstract

The purpose of the related LCD is to address the medical necessity of Erythropoiesis Stimulating Agents (ESAs) for conditions other than dialysis-related anemia and anemia related to cancers, both of which are subjects of national policies and directives. This article provides the reasons for denial and coding guidelines associated with administering ESA for the types of anemias addressed in the related LCD.

Naturally occurring human erythropoietin is a glycoprotein produced mainly in the kidneys. It stimulates the division and differentiation of committed erythroid progenitors in bone marrow. A number of chronic conditions may result in the decreased production of erythropoietin, often causing anemia. Supplementation with synthetic drugs with structures identical or similar to naturally occurring erythropoietin may assist in correcting anemia in certain groups of patients, but is associated with serious adverse events such as death, stroke or tumor progression.

Normal plasma erythropoietin levels vary from 0.01 to 0.03 U/ml (10 to 30 MU/ml). These levels may increase 100- to 1,000-fold during hypoxia or anemia and one may see levels from 1,000 to 30,000 MU/ml. Anemia of Chronic Renal Failure (CRF) as well as certain other anemias may respond to supplemental erythropoietin administration.

Epoetin Alfa (EPO) and Darbepoetin Alfa (DPO) are covered under Medicare Parts A or B when it is administered “incident to” a physician’s services and when specific Medicare coverage criteria are met.

CMS has issued several instructions or policies with regard to ESAs. These are listed in the related LCD in the section titled “CMS National Coverage Policy.” The related LCD provides coverage statements for those indications for ESAs not included in national directives and additional interpretive guidelines for those indications that are included in national directives.

Refer to the CMS Medicare Claims Processing Manual – Pub. 100-04, Chapter 8, Section 60, for ESA therapy for dialysis patients. Use of ESA for dialysis patients will not be addressed in the related LCD.

Part A Program Instructions:

Reasons for Denial

· All coverage criteria must be met before this service can be reimbursed by Medicare.

· All other indications not listed in the “Indications and Limitations of Coverage and/or Medical Necessity” section of the related LCD.

· Service(s) rendered is not consistent with accepted standards of medical practice.

· The medical record does not verify that the service described by the HCPCS code was provided.

· The medical record does not verify that the route of administration was medically necessary.

· The amount of drug wasted is not reasonable or documented.

· The service does not follow the guidelines of the related LCD.

· The service is considered:

o Investigational.

o Otherwise not covered.

o Never medically necessary.

· Non-Food and Drug Administration (FDA)-approved uses and off-label uses not supported by peer-reviewed literature.

· J0881 and J0885 claims filed with EA modifier (ESA, anemia, chemo-induced) with hemoglobin (Hgb) greater than 10.0g/dL or hematocrit (Hct) greater than 30.0 percent.

· J0881 and J0885 claims filed with EB modifier (ESA, anemia, radio-induced).

· J0881 and J0885 claims filed with EC modifier (ESA, anemia, non-chemo/radio) with a non-covered ICD-9-CM code listed in the related LCD.

· J0881 and J0885 claims filed with EC modifier (ESA, anemia, non-chemo/radio) with Hgb greater than 11.0 g/dL or Hct greater than 33.0 percent.

· Effective with the effective date of this LCD, Medicare will cover no more than 400,000 IU of EPO per month for any indication.

· Effective with the effective date of this LCD, Medicare will cover no more than 1,200 mcgs of DPO per month for any indication.

Coding Guidelines

· Refer to the Correct Coding Initiative (CCI) for correct coding guidelines and specific applicable code combinations prior to billing Medicare. Provisions of this LCD do not take precedence over CCI edits.

· Diagnosis(es) must be present on any claim submitted, coded to the highest level of specificity and representative of the patient’s condition.

· Do not bill chemotherapy administration codes for EPO or DPO administration.

· To report these services, use the appropriate HCPCS code.

· Medicare would not expect to see DPO codes J0881 and J0882 billed on the same date of service.

· There are dual-diagnosis requirements for non-dialysis EPO (J0885) and DPO (J0881). Refer to the LCD limited coverage sections for the correct coding combinations.

· When billing diagnosis code 998.11 for EPO (J0885), it is expected that the patient is scheduled to undergo elective non-cardiac, non-vascular surgery.

· HCPCS codes J0882 and J0886 are to be reported for patients on dialysis only.

· When billing for this service in a non-covered situation (e.g., does not meet indications of the related LCD), use the appropriate modifier (see below). To bill the patient for services that are not covered (investigational/experimental or not reasonable and necessary) will generally require an Advance Beneficiary Notice (ABN) be obtained before the service is rendered.

o Modifiers:

§ GA: Waiver of liability statement issued as required by payer policy, individual case. (Use for patients who do not meet the covered indications and limitations of this LCD and for whom an ABN is on file.) (ABN does not have to be submitted but must be made available upon request.)

§ GZ: Item or service expected to be denied as not reasonable and necessary. (Use for patients who do not meet the covered indications and limitations of this LCD and who did not sign an ABN and the provider expects the item/service to be denied. All claim line items submitted with the GZ modifier will be denied automatically and will not be subject to complex medical review.)

§ Effective for dates of service on or after January 1, 2008, non-ESRD claims for J0881 and J0885 require reporting of the most recent Hct and/or Hgb on claims for ESA administrations.

· Effective for dates of service on or after January 1, 2008, non-ESRD claims for J0881 and J0885 require reporting of a modifier to indicate the cause of the symptomatic anemia treated with ESAs. The modifiers are EA, EB and EC. Only one of these modifiers is allowed per detail line.

o ESA Modifiers:

§ EA: ESA, anemia, chemo-induced.

§ EB: ESA, anemia, radio-induced.

§ EC: ESA, anemia, non-chemo/radio-induced.

· Effective January 1, 2008, claims for J0881 and J0885 billed with modifier EC, the following conditions are CMS’ listed non-covered conditions. Use ICD-9-CM code V49.89 to indicate the non-covered condition(s) below:

o Any anemia in cancer or cancer treatment patients due to bone marrow fibrosis.

o Anemia of cancer not related to cancer treatment.

o Prophylactic use to prevent chemotherapy-induced anemia.

o Prophylactic use to reduce tumor hypoxia.

o Patients with erythropoietin-type resistance due to neutralizing antibodies.

o Anemia due to cancer treatment if patients have uncontrolled hypertension.

· The EC modifier may ONLY be used if the medical record or claims history indicates that the patient does not have anemia related to cancer chemotherapy or radiation.

· See also Bill Type and Revenue Code sections below.

Coding Drug Wastage (JW Modifier)

Medicare provides payment for the discarded drug/biological remaining in a single-use drug product after administering what is reasonable and necessary for the patient’s condition. If the physician has made good faith efforts to minimize the unused portion of the drug/biological in how patients are scheduled and how he ordered, accepted, stored and used the drug and made good faith efforts to minimize the unused portion of the drug in how it is supplied, then the program will cover the amount of drug discarded along with the amount administered. If after taking the above measures a portion of the single-use vial must be discarded, HCPCS modifier JW may be used to indicate the drug amount discarded/not administered to any patient. The amount administered and the amount wasted must be billed on the same claim. The amount administered must be on a separate detail line from the amount wasted, indicated with the modifier JW (when applicable). The modifier JW would not be used for claim billings when the actual dose of the drug/biological administered is less than the billing unit established by HCPCS description (e.g., the description of the HCPCS code already includes the amount administered along with the amount wasted. Example: 75 mg of meperidine HCl (J2175, meperidine hydrochloride, per 100 mg) is administered. Bill HCPCS code J2175 quantity “1.” Payment will be provided for J2175, 100 mg, which includes the amount administered (75 mg) and the amount discarded (25 mg)). Please reference “Drug Wastage” at http://www.trailblazerhealth.com/Publications/Job%20Aid/Drug%20Wastage.pdf for examples of determining the correct way of billing drug wastage to Medicare.

Part B Program Instructions:

Reasons for Denial

· All coverage criteria must be met before this service can be reimbursed by Medicare.

· All other indications not listed in the “Indications and Limitations of Coverage and/or Medical Necessity” section of the related LCD.

· Service(s) rendered is not consistent with accepted standards of medical practice.

· The medical record does not verify that the service described by the HCPCS code was provided.

· The medical record does not verify that the route of administration was medically necessary.

· The amount of drug wasted is not reasonable or documented.

· The service does not follow the guidelines of the related LCD.

· The service is considered:

o Investigational.

o Otherwise not covered.

o Never medically necessary.

· Non-Food and Drug Administration (FDA)-approved uses and off-label uses not supported by peer-reviewed literature.

· J0881 and J0885 claims filed with EA modifier (ESA, anemia, chemo-induced) with Hgb greater than 10.0g/dL or Hct greater than 30.0 percent.

· J0881 and J0885 claims filed with EB modifier (ESA, anemia, radio-induced).

· J0881 and J0885 claims filed with EC modifier (ESA, anemia, non-chemo/radio) with a non-covered ICD-9-CM code listed in the related LCD.

· J0881 and J0885 claims filed with EC modifier (ESA, anemia, non-chemo/radio) with Hgb greater than 11.0 g/dL or Hct greater than 33.0 percent.

· Effective with the effective date of this LCD, Medicare will cover no more than 400,000 IU of EPO per month for any indication.

· Effective with the effective date of this LCD, Medicare will cover no more than 1,200 mcgs of DPO per month for any indication.

Coding Guidelines

· Diagnosis(es) must be present on any claim submitted, coded to the highest level of specificity and representative of the patient’s condition.

· Do not bill chemotherapy administration codes for EPO or DPO administration.

· To report these services, use the appropriate HCPCS code.

· Medicare would not expect to see DPO codes J0881 and J0882 billed on the same date of service.

· There are dual-diagnosis requirements for non-dialysis EPO (J0885) and DPO (J0881). Refer to the LCD limited coverage sections for the correct coding combinations.

· When billing diagnosis code 998.11 for EPO (J0885), it is expected that the patient is scheduled to undergo elective non-cardiac, non-vascular surgery.

· HCPCS codes J0882 and J0886 are to be reported for patients on dialysis only.

o Modifiers:

§ Effective for dates of service on or after January 1, 2008, non-ESRD claims for J0881 and J0885 require reporting of the most recent Hct and/or Hgb on claims for ESA administrations.

o ESA Modifiers:

§ EA: ESA, anemia, chemo-induced.

§ EB: ESA, anemia, radio-induced.

§ EC: ESA, anemia, non-chemo/radio-induced.

o Any anemia in cancer or cancer treatment patients due to bone marrow fibrosis.

o Anemia of cancer not related to cancer treatment.

o Prophylactic use to prevent chemotherapy-induced anemia.

o Prophylactic use to reduce tumor hypoxia.

o Patients with erythropoietin-type resistance due to neutralizing antibodies.

o Anemia due to cancer treatment if patients have uncontrolled hypertension.

· The EC modifier may ONLY be used if the medical record or claims history indicates that the patient does not have anemia related to cancer chemotherapy or radiation.

· Bill Type and Revenue Codes below DO NOT apply to Part B.

Coding Drug Wastage (JW Modifier)

Bill Type Codes

Contractors may specify Bill Types to help providers identify those Bill Types typically used to report this service. Absence of a Bill Type does not guarantee that the policy does not apply to that Bill Type. Complete absence of all Bill Types indicates that coverage is not influenced by Bill Type and the policy should be assumed to apply equally to all claims.

12X, 13X, 18X, 21X, 22X, 23X, 85X

Revenue Codes

Contractors may specify Revenue Codes to help providers identify those Revenue Codes typically used to report this service. In most instances Revenue Codes are purely advisory; unless specified in the policy services reported under other Revenue Codes are equally subject to this coverage determination. Complete absence of all Revenue Codes indicates that coverage is not influenced by Revenue Code and the policy should be assumed to apply equally to all Revenue Codes.

Note: TrailBlazer has identified the Bill Type and Revenue Codes applicable for use with the CPT/HCPCS codes included in this LCD. Providers are reminded that not all CPT/HCPCS codes listed can be billed with all Bill Type and/or Revenue Codes listed. CPT/HCPCS codes are required to be billed with specific Bill Type and Revenue Codes. Providers are encouraged to refer to the CMS Internet-Only Manual Publication 100-04, Claims Processing Manual, for further guidance.

0450, 0634, 0635, 0636

CPT/HCPCS Codes

Note:	Providers are reminded to refer to the long descriptors of the CPT codes in their CPT book. The American Medical Association (AMA) and CMS require the use of short CPT descriptors in LCDs published on the Web.
J0881	Injection, darbepoetin alfa, 1 mcg (non ESRD)
J0885	Injection, epoetin alfa, per 1000 units (non ESRD)

Modifier Definitions:

· EA: ESA, anemia, chemo-induced.

· EB: ESA, anemia, radio-induced.

· EC: ESA, anemia, non-chemo/radio-induced.

Other Comments

Medicare will consider changing its LCD when additional supportive data and peer-reviewed literature support the safety and effectiveness of EPO injections. Medicare expects that the studies submitted to support expansion of indications have been entered on the clinical trials.gov database or other database accepted by the International Committee of Medical Journal Editors before the first patient was enrolled in the study.