Contractor Information
Contractor Name:
Highmark Medicare Services
Contractor Number:
12102, 12202, 12302
Contractor Type:
MAC Part A & B
LCD Information
LCD Database ID Number
L27492
LCD Title
Erythropoiesis Stimulating Agents (ESAs)
Contractor’s Determination Number
L27492
AMA CPT/ADA CDT Copyright Statement
CPT codes, descriptions and other data only are copyright 2007 American Medical Association (or such other date of publication of CPT). All Rights Reserved. Applicable FARS/DFARS Clauses Apply. Current Dental Terminology, (CDT) (including procedure codes, nomenclature, descriptors and other data contained therein) is copyright by the American Dental Association. © 2002, 2004 American Dental Association. All rights reserved. Applicable FARS/DFARS apply.
CMS National Coverage Policy
NCDs and coverage provisions in interpretive manuals are not subject to the LCD Review Process (42 CFR 405.860[b] and 42 CFR 426 [Subpart D]). In addition, an administrative law judge may not review an NCD. See §1869(f)(1)(A)(i) of the Social Security Act.
Title XVIII of the Social Security Act, Section 1862(a)(1)(A) states that no Medicare payment shall be made for items or services which are not reasonable and necessary for the diagnosis or treatment of illness or injury.
Title XVIII of the Social Security Act, Section 1862(a)(7). This section excludes routine physical examinations.
Title XVIII of the Social Security Act, Section 1833(e) states that no payment shall be made to any provider for any claim that lacks the necessary information to process the claim.
Title XVIII of the Social Security Act (SSA), Section 1881(b)(1) allows payment for services furnished to individuals who have been determined to have end stage renal disease.
Title XVIII of the Social Security Act (SSA), Section 1881(11)(B)(I) allows payment for erythropoietin provided by a physician.
CMS Publications:
CMS Publication 100-02, Medicare Benefit Policy Manual, Chapter 1:
30 Drugs and Biologicals
CMS Publication 100-02, Medicare Benefit Policy Manual, Chapter 6:
30 Drugs and Biologicals
CMS Publication 100-02, Medicare Benefit Policy Manual, Chapter 11:
30.1 Frequency of Dialysis Sessions
30.4 Drugs and Biologicals
30.5 New ESRD Composite Payment Rates Effective January 1, 2005
90 Epoetin (EPO)
CMS Publication 100-02, Medicare Benefit Policy Manual, Chapter 15:
50 Drugs and Biologicals
50.1 Definition of Drug or Biological
50.2 Determining Self-Administration of Drug or Biological
50.3 Incident-to Requirements
50.4.1 Approved Use of Drug
50.4.3 Examples of Not Reasonable and Necessary
50.5.2 Erythropoietin (EPO)
50.5.2.1 Requirements for Medicare Coverage for EPO [home use]
50.5.2.2 Medicare Coverage of Epoetin Alfa (Procrit) for Preoperative Use
CMS Publication 100-04, Medicare Claims Processing Manual, Chapter 6:
10.1 Consolidated Billing Requirement for SNFs
20.2 Services Excluded from Part A PPS Payment …
20.2.1 Dialysis and Dialysis Related Services to a Beneficiary With ESRD
20.2.1.1 ESRD Services
CMS Publication 100-04, Medicare Claims Processing Manual, Chapter 8:
10.5 Hospital Services
60.2.3.1 Requirement for Providing Route of Administration Codes for Erythropoiesis Stimulating Agents (ESAs)
60.4 Epoetin Alfa (EPO)
60.4.1 Epoetin Alfa (EPO) Facility Billing Requirements
60.4.3 Payment Amount for Epoetin Alfa (EPO)
60.4.3.1 Payment for Epoetin Alfa (EPO) in Other Settings
60.4.3.2 Epoetin Alfa (EPO) Provided in the Hospital Outpatient Department
60.7 Darbepoetin Alfa (Aranesp®) for ESRD Patients
60.7.1 Darbepoetin Alfa (Aranesp®) Facility Billing Requirements Using UB-92/Form CMS-1450
60.7.3 Payment Amount for Darbepoetin Alfa (Aranesp®)
60.7.3.2 Payment for Darbepoetin Alfa (Aranesp®) in the Hospital Outpatient Department
80.2.1 Required Billing Information for Method I Claims
90 Method II Billing
90.5 Method II Support Services Billed to the Intermediary by the Facility
90.5.1 Billable UB-92 Revenue Codes Under Method II
90.5.1.1 Unbillable UB-92 Revenue Codes Under Method II
CMS Publication 100-04, Medicare Claims Processing Manual, Chapter 17:
10 Payment Rules for Drugs and Biologicals
20.5.8 Injections Furnished to ESRD Beneficiaries
CMS Publication 100-04, Medicare Claims Processing Manual, Chapter 25:
60 General Instructions for Completion of Form CMS-1450 for Billing
CMS Publication 100-04, Medicare Claims Processing Manual, Chapter 27:
80.8 ESRD Maintenance Transaction Error Codes.
CMS Publication 100-04, Medicare Claims Processing Manual, Transmittal No. 1212, Change Request #5480, March 30, 2007, Requirement for Providing Route of Administration Codes for Erythropoiesis Stimulating Agents (ESAs).
CMS Publication 100-04, Medicare Claims Processing Manual, Transmittal No. 1041, Change Request #5216, August 25, 2006, confirms that hospitals are to continue to report administration of epoetin alfa using revenue codes 634 and 635 and replaces HCPCS code J0886 with Q4081 for bill types 12X, 13X, 72X, and 85X for dates of service on or after 01/01/2007.
CMS Publication 100-04, Medicare Claims Processing Manual, Transmittal No. 1043, Change Request #5251, August 25, 2006, revises the definition of the GS modifier.
CMS Publication 100-04, Medicare Claims Processing Manual, Transmittal No. 751, Change Request #4135, November 10, 2005, describes a new national monitoring policy for Erthropoietin and Darbepoetin (EPO and Aranesp) for ESRD patients treated in renal dialysis facilities.
CMS Publication 100-04, Medicare Claims Processing Manual, Transmittal No. 737, Change Request #4108, October 31, 2005, provides updated HCPCS codes for epoetin alfa and darbepoetin alfa.
CMS Publication 100-04, Medicare Claims Processing Manual, Transmittal No. 736, Change Request #4103, October 31, 2005, re-defines value code 49 and provides revenue coding instructions for bill type 12X.
CMS Publication, Medicare Coverage of Erythropoietin Stimulating Agents. Includes link to Decision Memo for Erythropoiesis Stimulating Agents (ESAs) for non-renal disease indications (CAG-00383N).
CMS Publication, 100-04, Medicare Claims Processing Manual, Transmittal No. 1285, Change Request #5545, July 13, 2007, completes the implementation of ESRD line item billing for Renal Dialysis Facilities (RDFs) by providing instructions required to submit line item billing EPO on ESRD claims. RDFs will no longer be required to report the value code 68 with the total monthly dosage. The GS modifier will now be reported on the line item(s) that represent an administration of EPO at the reduced dosage.
CMS Publication, 100-04, Medicare Claims Processing Manual, Transmittal No. 1307, Change Request #5700, July 20, 2007, Modification to the National Monitoring Policy for Erythropoietic Stimulating Agents (ESAs) for End-Stage Renal Disease (ESRD) Patients Treated in Renal Dialysis Facilities. Instructions regarding modifiers ED and EE effective January 1, 2008.
CMS Publication, IOM 100-03, Medicare National Coverage Determinations (NCD) Manual, Transmittal No. 80, Change Request #5818, January 14, 2008, describes the NCD for the use of ESAs in Cancer and Related Neoplastic Conditions.
CMS Publication, IOM 100-04, Medicare Claims Processing Manual, Transmittal No. 1413, Change Request #5818, January 14, 2008, describes the coding and claims processing rules for the use of ESAs in Cancer and Related Neoplastic Conditions.
CMS Publication, IOM 100-04, Medicare Claims Processing Manual, Transmittal No. 1412, Change Request #5699, January 11, 2008, describes the coding and claims processing rules for the Reporting of Hematocrit or Hemoglobin Levels on All Claims for the Administration of Erythropoiesis Stimulating Agents (ESAs), Implementation of New Modifiers for Non-ESRD Indications, and Reporting of Hematocrit/Hemoglobin Levels on all Non-ESRD, Non-ESA Claims Requesting Payment for Anti-Anemia Drugs.
CMS Publication, IOM 100-04, Medicare Claims Processing Manual, Transmittal No. 1503, Change Request #6047, May 16, 2008, describes the revisions to the billing requirements for ESRD-Related Epoetin Alfa (EPO) and Darbepoetin Alfa (Aranesp) administrations provided during unscheduled or emergency dialysis treatments in the outpatient hospital setting.
Primary Geographic Jurisdiction
Maryland, District of Columbia, Delaware
Oversight Region
Central Office
Original Determination Effective Date
For services performed on or after 07/11/2008
Original Determination Ending Date
N/A
Revision Effective Date
For services performed on or after N/A
Revision Ending Date
N/A
Indications and Limitations of Coverage and/or Medical Necessity
Compliance with the provisions in this policy may be monitored and addressed through post payment data analysis and subsequent medical review audits.
NOTE:
- There is an updated NCD for use of Erythropoiesis Stimulating Agents, ESAs, in Cancer and Related Neoplastic Conditions. These uses are not addressed in this LCD. Please see Change Request (CR) 5818 (details in CMS National Coverage Policy section, above) and MLN Matters article number MM5818 for specific instructions on these uses of ESAs. This CR is retroactive to July 30, 2007.
- One area of the NCD discussed in CR 5818 does not have specific ICD-9-CM codes. Please see this contractor’s Billing and Coding article for further instructions (to follow).
- The CR 5699 (details in CMS National Coverage Policy section, above) and MLN Matters article number MM5699 give specific instructions on the reporting of hematocrit or hemoglobin levels with use of ESAs, as well as other anti-anemia drug use. They further describe the modifiers required. This CR is retroactive to January 1, 2008.
An erythropoietin stimulating agent (ESA) is an analog of erythropoietin. ESAs are biologically engineered hormones produced by recombinant DNA technology. Erythropoietin analogs contain the identical amino acid sequence as naturally occurring erythropoietin, and have the same biological effect. Primarily, the kidneys produce erythropoietin in response to hypoxia. Both erythropoietin and ESAs stimulate the bone marrow to form new red blood cells. They are used to treat anemia by elevating or maintaining the red blood cell level (as demonstrated by the hematocrit and/or hemoglobin levels), therefore decreasing anemia and the need for transfusions. Darbepoetin alfa (brand name Aranesp ®), an erythropoietin analog, differs from recombinant human erythropoietin alfa (brand name Epogen ® or Procrit ®) in having two additional N-glycosylation sites, which slows its clearance and makes its half-life two-three times longer, allowing less frequent injections. This policy will apply to new ESAs as they are approved.
Since darbepoetin alfa and epoetin alfa have a similar mode of action and their structures differ only by the number of N-linked oligosaccharides on the protein, this policy does not distinguish differences for on or off-label indications and contraindications, except for pre treatment of selective surgery where blood loss is anticipated. Several off-label uses are well-accepted clinically, as indicated by inclusion in various compendia. However, a contraindication for either ESA is binding on both. In March 2007, the FDA issued new warnings against target Hb levels above 12 g/dL (36% Hct) “for all patients.” The FDA also issued specific warnings against off-label use in cancer patients whose anemia is not directly linked to chemotherapy. The FDA also reminded physicians that the main endpoint in studies for on-label indications has been avoidance or reduction in transfusions. The LCD contains descriptions of specific coverage guidelines and documentation that supports medical necessity for individual patients.
CMS has both a National Coverage Determination (NCD) and a National Benefit Policy regarding uses of ESAs. These are listed in the CMS National Coverage Policy section of this Local Coverage Determination (LCD), above. This LCD (I) provides clarification and additional coding information for the National Benefit Policy, and (II) provides additional coverage information for uses of ESAs not specified in the NCD.
(I.) This contractor considers the ICD-9-CM codes listed in the coding section below to be covered, when ESAs are used in keeping with the National Benefit Policy for the treatment of anemia associated with chronic renal failure, including patients on dialysis and patients not on dialysis.
(II.) Erythropoiesis Stimulating Agents (ESAs) may be considered reasonable and necessary for the treatment of anemia associated with any of the following conditions, which are not specified in the NCD:
- Treatment of anemia induced by AZT used in treatment of HIV/AIDS;
- Treatment of selected patients with anemia related to myelodysplastic syndrome;
- Perisurgical adjuvant therapy (epoetin alfa only);
- Treatment of anemia of selected chronic diseases: rheumatoid arthritis, systemic lupus erythematosus, inflammatory bowel diseases, and hepatitis C undergoing treatment.
The following causes of anemia should be considered, documented, and corrected (when possible) before starting erythropoietin analogue therapy for any of the covered indications:
1. Iron deficiency;
2. Underlying infection or inflammatory process;
3. Underlying hematological disease;
4. Hemolysis;
5. Vitamin deficiencies (e.g. folic acid or B12);
6. Blood loss;
7. Aluminum intoxication.
There are rare patients whose cardiac, pulmonary or other medical diseases warrant the use of ESAs to maintain a hemoglobin/hematocrit (Hb/HCT) higher than the levels discussed in this LCD. Documentation to support this practice must be available upon request.
During therapy with an erythropoietin analog, many patients will eventually require supplemental iron. For these patients, stores of iron should be regularly monitored to ensure a transferrin saturation greater than 20% and/or serum ferritin levels greater than 100 ng/ml, in order to guide appropriate supplementation.
Coverage Criteria:
A. For End Stage Renal Disease (ESRD) patients on dialysis:
- Diagnosis of end stage renal disease;
- Anemia of ESRD. Treatment with ESAs is given to achieve and maintain a Hb level of 10-12 gm/dl.
B. For chronic kidney disease patients NOT on dialysis:
- Anemia. Treatment with ESAs is given to achieve and maintain a Hb level of 10-12 gm/dl.
- Creatinine clearance less than 60 ml/min, or glomerular filtration rate (GFR) less than 60 ml/min/1.73 m2.
C. For patients with anemia related to AZT therapy for HIV/AIDS:
- Anemia with Hb/HCT less than 10 / 30% at initiation of therapy. Treatment with ESAs is given to achieve and maintain a Hb level of 10-12 gm/dl.
D. For patients with myelodysplastic syndrome (MDS):
- MDS with bone marrow blast count of less than 10% blasts.
- Pretreatment erythropoietin levels less than or equal to 500 IU/L, for ESA therapy initiated on or after the effective date of this LCD.
- Anemia associated with MDS, with Hb/HCT less than 10 / 30% at initiation of therapy. Treatment with ESAs is given to achieve and maintain a Hb level of 10-12 g/dl.
E. Perisurgical adjuvant therapy: epoetin alfa for patients who:
- Are undergoing hip or knee surgery;
- Have an anemia with a Hb between 10 and 13 gm/dL;
- Are not candidates for autologous blood transfusion;
- Are expected to lose more than two units of blood;
- Have been evaluated to ensure that their anemia is due to chronic disease.
F. For patients with anemia of chronic disease:
- Anemia with Hb/HCT less than 10 / 30% at initiation of therapy. Treatment with ESAs is given to achieve and maintain a Hb level of 10-12 gm/dl.
The literature covering use of ESAs for anemia of chronic disease is mixed, though developing. Most reported studies are small, and positive effects must be balanced with newer data that shows some patients given ESAs with anemia of cancer have shorter survival times. Currently there is evidence of patient benefit using ESA therapy to reduce transfusions for selected patients with significant refractory and symptomatic anemia who have inflammatory diseases (rheumatoid arthritis, Crohn’s disease, ulcerative colitis), and hepatitis C with anemia due to the medication therapy. Until further publications show clear benefit, ESAs for anemia of other chronic diseases other than those listed (rheumatoid arthritis, systemic lupus erythematosus, inflammatory bowel diseases, and hepatitis C undergoing treatment), will not be covered.
Coverage Topic
Doctor Office Visits, Outpatient Hospital Services, Prescription Drugs
Coding Information
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.
11x | Hospital-inpatient (including Part A) |
12x | Hospital-inpatient or home health visits (Part B only) |
13x | Hospital-outpatient (HHA-A also) (under OPPS 13X must be used for ASC claims submitted for OPPS payment -- eff. 7/00) |
21x | SNF-inpatient, Part A |
22x | SNF-inpatient or home health visits (Part B only) |
23x | SNF-outpatient (HHA-A also) |
72x | Clinic-hospital based or independent renal dialysis facility |
83x | Special facility or ASC surgery-ambulatory surgical center (Discontinued for Hospitals Subject to Outpatient PPS; hospitals must use 13X for ASC claims submitted for OPPS payment -- eff. 7/00) |
85x | Special facility or ASC surgery-rural primary care hospital (eff 10/94) |
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.
0634 | Drugs requiring specific identification-EPO under 10,000 units |
0635 | Drugs requiring specific identification-EPO 10,000 units or more |
0636 | Drugs requiring specific identification-detailed coding (eff 3/92) |
CPT/HCPCS Codes
Italicized and/or quoted material is excerpted from the American Medical Association, Current Procedural Terminology (CPT) codes.
J0881 | INJECTION, DARBEPOETIN ALFA, 1 MICROGRAM (NON-ESRD USE) |
J0882 | INJECTION, DARBEPOETIN ALFA, 1 MICROGRAM (FOR ESRD ON DIALYSIS) |
J0885 | INJECTION, EPOETIN ALFA, (FOR NON-ESRD USE), 1000 UNITS |
J0886 | INJECTION, EPOETIN ALFA, 1000 UNITS (FOR ESRD ON DIALYSIS) |
Q4081 | INJECTION, EPOETIN ALFA, 100 UNITS (FOR ESRD ON DIALYSIS) |
ICD-9 Codes that Support Medical Necessity
It is the provider’s responsibility to select codes carried out to the highest level of specificity and selected from the ICD-9-CM code book appropriate to the year in which the service is rendered for the claim (s) submitted.
For Patients on Dialysis (Both diagnoses must be on claim.)
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For patients with chronic kidney disease (not yet on dialysis) and anemia – must include 285.21 and one other listed diagnosis.
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Patients with anemia related to treatment with zidovudine (AZT) for HIV disease. Must have 284.89 (aplastic anemia due to drugs) and either 042 or 079.53 on claim.
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Patients with anemia related to Myelodysplastic Syndrome.
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Preoperative use in specified patients. Must have an anemia diagnosis (Note: 285.29 or 285.9) and other specified prophylactic measure diagnosis. (Anemia must be primary diagnosis).
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* Do not use this code to identify uses of ESAs associated with cancer and related neoplastic conditions. Specifically do not use this code to identify the following, which are non-covered under the NCD: prophylactic use to prevent chemotherapy-induced anemia, and / or prophylactic use to reduce tumor hypoxia. Please see this contractor’s Billing and Coding article for further instructions regarding the NCD. |
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For patients with hepatitis C and anemia of chronic inflammatory diseases must include 285.29 (anemia of other chronic disease) and one other listed diagnosis. |
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070.41 |
ACUTE HEPATITIS C WITH HEPATIC COMA |
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070.44 |
CHRONIC HEPATITIS C WITH HEPATIC COMA |
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070.51 |
ACUTE HEPATITIS C WITHOUT MENTION OF HEPATIC COMA |
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070.54 |
CHRONIC HEPATITIS C WITHOUT HEPATIC COMA |
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070.70 |
UNSPECIFIED VIRAL HEPATITIS C WITHOUT HEPATIC COMA |
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070.71 |
UNSPECIFIED VIRAL HEPATITIS C WITH HEPATIC COMA |
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285.29 |
ANEMIA OF OTHER CHRONIC DISEASE |
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555.0 |
REGIONAL ENTERITIS OF SMALL INTESTINE |
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555.1 |
REGIONAL ENTERITIS OF LARGE INTESTINE |
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555.2 |
REGIONAL ENTERITIS OF SMALL INTESTINE WITH LARGE INTESTINE |
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555.9 |
REGIONAL ENTERITIS OF UNSPECIFIED SITE |
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556.0 |
ULCERATIVE (CHRONIC) ENTEROCOLITIS |
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556.1 |
ULCERATIVE (CHRONIC) ILEOCOLITIS |
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556.2 |
ULCERATIVE (CHRONIC) PROCTITIS |
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556.3 |
ULCERATIVE (CHRONIC) PROCTOSIGMOIDITIS |
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556.4 |
PSEUDOPOLYPOSIS OF COLON |
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556.5 |
LEFT-SIDED ULCERATIVE (CHRONIC) COLITIS |
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556.6 |
UNIVERSAL ULCERATIVE (CHRONIC) COLITIS |
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556.8 |
OTHER ULCERATIVE COLITIS |
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556.9 |
ULCERATIVE COLITIS UNSPECIFIED |
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710.0 |
SYSTEMIC LUPUS ERYTHEMATOSUS |
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714.0 |
RHEUMATOID ARTHRITIS |
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E931.7 |
ANTIVIRAL DRUGS CAUSING ADVERSE EFFECTS IN THERAPEUTIC USE |
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Diagnoses that Support Medical Necessity
N/A
ICD-9 Codes that DO NOT Support Medical Necessity
All those not listed under the “ICD-9 Codes that Support Medical Necessity” section of this policy.
ICD-9 Codes that DO NOT Support Medical Necessity Asterisk Explanation
Diagnoses that DO NOT Support Medical Necessity
Conditions that are not listed in the "ICD-9-CM Codes that Support Medical Necessity" section of this policy.
General Information
Documentation Requirements
- All documentation must be maintained in the patient’s medical record and available to the contractor upon request.
- Every page of the record must be legible and include appropriate patient identification information (e.g., complete name, dates of service(s)). The record must include the physician or non-physician practitioner responsible for and providing the care of the patient.
- The submitted medical record should support the use of the selected ICD-9-CM code(s). The submitted CPT/HCPCS code should describe the service performed.
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. Documentation the provider is to maintain in the patient’s medical record include: patient’s weight; erythropoietin analogue units administered per kilogram of body weight; and medical justification for administration of erythropoietin analogues exceeding usual doses.
Documentation supporting the indication for erythropoietin analogues administration must be made available upon the request; for all patients, this includes Hb/HCT and documentation of adequate iron stores. Additional information is determined by indication. Regular reporting of Hb/HCT is needed to show monitoring of ESA dose.
Dialysis Patients: dialysis schedule, Hb/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 upon request: a care plan; evidence of home monitoring (including a record of the erythropoietin analogue supplied to the patient and a record of dose administration); patient instructions; and patient selection protocol.
Non-dialysis Patients / Chronic renal failure patients: creatinine clearance or GFR supporting a diagnosis of chronic renal failure.
Patients with myelodysplastic syndrome: date of initiation of erythropoietin analogue therapy, and response to erythropoietin analogue administration (change in Hb/HCT and/or transfusion requirements). Pretreatment erythropoietin levels, for ESA therapy initiated on or after the effective date of this LCD. For patients on ESA therapy for MDS, initiated prior to the effective date of this LCD, a physician’s statement that the patient has MDS must be included in the medical record. For ESA therapy initiated on or after the effective date of this LCD, a copy of the actual bone marrow biopsy report, including the bone marrow blast count (%), must be included in the medical record.
Utilization Guidelines
In accordance with CMS Ruling 95-1 (V), utilization of these services should be consistent with locally acceptable standards of practice.
For ESRD patients, the maximum number of administrations of epoetin alfa for a billing cycle is 13 times in 30 days and 14 times in 31 days (CMS Publication 100-04, Medicare Claims Processing Manual, Chapter 8, Section 60.4.1)
Darbepoetin alfa is given not more than once per week according to its Food and Drug Administration-approved labeling (see label issued March 24, 2006). For this reason, we will allow it to be billed a maximum of five times during any calendar month (CMS Publication 100-04, Medicare Claims Processing Manual, Chapter 8, Section 60.7.1)
Providers are reminded that CMS expects that as the hematocrit approaches 36.0% (hemoglobin 12.0g/dL), a dosage reduction occurs. Providers are expected to maintain hematocrit levels between 30.0 to 36.0% (hemoglobin 10.0- 12.0g/dL). Hematocrit levels that remain below 30.0% (hemoglobin levels below 10.0g/dL)) despite dosage increases, should have causative factors evaluated. The patient’s medical record should reflect the clinical reason for dose changes and hematocrit levels outside the range of 30.0-36.0% (hemoglobin levels 10.0-12.0g/dL).
Literature describes a significant increase in risk associated with hematocrit greater than 36. Prompt and judicious dose adjustments are anticipated in response to reaching the target Hb/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 Hb/HCT greater than 12/36.
Sources of Information and Basis for Decision
Highmark Medicare Services is not responsible for the continuing viability of Web site addresses listed below.
2007 USP DI®, Copyright© 2007 by MICROMEDEX Thompson Healthcare.
Aranesp® (darbepoetin alfa) [package insert and patient information]. Thousand Oaks, CA: Amgen 2008.
Bucaloiu I, et al. Outpatient Erythropoietin Administered Through a Protocol-Driven, Pharmacist-Managed Program May Produce Significant Patient and Economic Benefits. Managed Care Interface. 2007; 26-30.
Ebben J, Gilbertson D, Foley R, and Collins A. Hemoglobin Level Variability: Associations with Comorbidity, Intercurrent Events, and Hospitalizations. Clin J Am Soc Nephrol. 2006; 1-6.
Epogen® (Epoetin alfa) [package insert]. Thousand Oaks, CA: Amgen 2008.
Eschbach J, Abdulhadi M, Browne J, et al. Recombinant Human Erythropoietin in Anemic Patients with End-Stage Renal Disease. Annals of Internal Medicine. 1989:111; 992-1000.
Ferrario D, Farrari, L , Bidoli P, De Candis D, Del Vecchio M, De Dosso S, Buzzoni R, Bajetta E. Treatment of cancer-related anemia with epoetin alfa: a review. Ann Pharmacother. 2004 Dec;38(12):2145-9 Epub 2004 Oct 19.
Food and Drug Administration. Minutes of the Oncologic Drugs Advisory Committee of May 3, 2004. Available at: http://www.fda.gov/ohrms/dockets/ac/cder04.html#Oncologic Accessed on March 10, 2007.
Food and Drug Administration. Information for Health Care Professionals. Available at http://www.fda.gov/cder/Offices/OODP/whatsnew/esa.htm. Accessed on March 13, 2007.
Food and Drug Administration. Information for Healthcare Professionals. Erythropoiesis Stimulating Agents (ESA). Available at http://www.fda.gov/cder/drug/InfoSheets/HCP/RHE200711HCP.htm. Accessed on November 13, 2007.
Food and Drug Administration. FDA Approves New Labeling for Epogen, Procrit, and Aranesp. Available at http://www.fda.gov/cder/Offices/OODP/whatsnew/ESA200711.htm. Accessed on November 9, 2007.
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Other Contractors Policies
Highmark Medicare Services Contractor Medical Directors
Advisory Committee Meeting Notes
This policy does not reflect the sole opinion of the contractor or Contractor Medical Directors. Although the final decision rests with the contractor, this policy was developed in cooperation with advisory groups, which includes representatives from the appropriate specialty (ies).
CAC/IAC Distribution: 04/01/2008
Start Date of Comment Period
End Date of Comment Period:
05/15/2008
Start Date of Notice Period
05/23/2008
Revision History
Revision History Number
L27492
Revision History Explanation
| Date | Policy # | Description |
|---|---|---|
05/23/2008 |
L27492 |
Original LCD posted for notice. LCD to become effective 07/11/2008 for Maryland Part B, DCMA Part B and Delaware Part B. |
04/01/2008 |
Draft J12-D20 |
Original LCD posted for comment. |
Last Reviewed On
05/22/2008
Related Documents
LCD Attachments