Dear MOASC Members:

The MOASC office received the following information regarding the Holding of June 2010 Claims for Services Paid Under the 2010 Medicare Physician Fee Schedule.

The Continuing Extension Act of 2010, enacted on April 15, 2010, extended the zero percent (0%) update to the 2010 Medicare Physician Fee Schedule (MPFS) through May 31, 2010.

The Centers for Medicare & Medicaid Services (CMS) believes Congress is working to avert the negative update scheduled to take effect June 1, 2010. 
To avoid disruption in the delivery of health care services to beneficiaries and payment of claims for physicians, non-physician practitioners, and other providers of services paid under the MPFS, CMS has instructed its contractors to hold claims containing services paid under the MPFS (including anesthesia services) for the first 10 business days of June.
http://www.palmettogba.com/palmetto/providers.nsf/vMasterDID/85UND44454?opendocument

Arthur Lurvey, MD, FACP, FACE
Director, J1 Medical Affairs
Palmetto GBA
P.O. Box 1476
Augusta, Georgia 30903-1476

On Thursday, April 15,2010, the President signed H.R. 4851, the Continuing Extension Act of 2010, retroactively reversing the 21.3 percent Medicare physician payment cut that took effect on April 1 and extending 2009 payment rates through date of service  May 31, 2010.

      2010 J1 Part B Fee Schedules
      The 2010 J1 Part B Fee Schedules for California are now available and   are effective January 1, 2010. The 2010 J1 Part B Fee Schedules for Nevada, Hawaii, Guam, American Samoa and the Northern Mariana Islands    will be coming soon.
http://www.palmettogba.com/palmetto/providers.nsf/vMasterDID/7Y3GZA7365?opendocument
     
      J1 EDI Enrollment Packet
      The Jurisdiction 1 A/B MAC EDI Enrollment Packet has been updated with a new form. The Provider Authorization form must be completed by the provider to authorize a clearinghouse and/or billing service as an electronic submitter and recipient of electronic claims data. Please      begin using this updated packet immediately.
http://www.palmettogba.com/palmetto/providers.nsf/vMasterDID/7XPTLJ4585?opendocument   

Contractor Information
Contractor Name
Palmetto GBA
MAC - Part B

LCD Information
LCD ID Number
L28257

LCD Title
Erythropoietin Stimulating Agents (ESAs) for the Treatment of Anemia Unrelated to Dialysis Therapy

Contractor's Determination Number
J1B-08-0029-L

CMS National Coverage Policy
Title XVIII of the Social Security Act (SSA), Section 1862(a)(1)(A), states that no Medicare payment shall
be made for items or services that “are not reasonable and necessary for the diagnosis or treatment of illness
or injury or to improve the functioning of a malformed body member.”
Title XVIII of the Social Security Act, Section 1833(e), prohibits Medicare payment for any claim lacking
the necessary documentation to process the claim.
Title XVIII of the Social Security Act, Section 1881(b) addresses the use of ESA for patients with ESRD (on
dialysis). Social Security Act, Section 1881(11)(B)(I), addresses the exclusion of ESA as a dialysis service to
ESRD patients when provided by a physician in accordance with Section 1833. CMS Manual System,
Publication 100-04, Medicare Claims Processing Manual, Chapter 17, states that where ESA is furnished by a
facility, the intermediary makes payment. See also CMS Manual System, Publication 100-02, Medicare
Benefit Policy Manual, Chapter 15, Section 50.5.2.1, governs patients on dialysis. For example, under the
ESRD dialysis benefit, ESAs may be self-injected.

LCD for Erythropoietin Stimulating Agents (ESAs) for the Treatment of Anemia Unrelated to
Dialysis Therapy (L28257)
LCD Information
LCD ID Number
CMS Manual System, Publication 100-02, Medicare Benefit Policy Manual, Chapter 15, Section
50.5.2.1(B)(2)(b), establishes an epoetin alfa treatment goal of a hematocrit between 30 and 36 percent for a
dialysis patient. This guideline is specific to dialysis patients only.
CMS Manual System, Publication 100-02, Medicare Benefit Policy Manual, Chapter 11, Section 90,
addresses anemia associated with chronic renal failure, and states that epoetin alfa is covered under Part B if
administered "incident-to" a physician's services. This benefit usually applies to patients who do not yet
qualify for the Medicare dialysis benefit.
Medicare National Coverage Determination/Decision Memo CAG-00383N, July 30, 2007, defines coverage
limitations for ESAs in patients with anemia caused by chemotherapy. Also, ESAs are not covered for
patients with “anemia of cancer” unrelated to chemotherapy.
CMS Manual System, Publication 100-02, Medicare Benefit Policy Manual, Chapter 15, Section 50.5.2.2,
provides special conditions for coverage of pre-operative use of ESAs in anticipation of surgical blood loss.
CMS Manual System, Publication 100-02, Medicare Benefit Policy Manual, Chapter 15, Section 50, provides
general guidance on coverage of injected drugs incident-to a physician. This provides authorities for locallydefined
coverage of ESAs not otherwise defined by the program manual or NCDs.
Primary Geographic Jurisdiction
California - Southern
Oversight Region
Region I
Original Determination Effective Date
For services performed on or after 09/02/2008
Original Determination Ending Date
Revision Effective Date
For services performed on or after 10/01/2008
Revision Ending Date
Indications and Limitations of Coverage and/or Medical Necessity
LCD Information
LCD ID Number
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. Normally, the
kidneys produce adequate erythropoietin in response to hypoxia. Both natural erythropoietin and ESAs
stimulate the bone marrow to form new red blood cells. ESAs 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 2
additional N-glycosylation sites, which slows its clearance and makes its half-life 2-3 times longer, allowing
less frequent injections. A physician or other appropriately trained practitioner may administer an ESA. This
LCD will apply to new ESAs as they are marketed.
The FDA-approved indications for epoetin alfa are: treatment of anemia associated with chronic renal failure
(CRF); Zidovudine-treated HIV infected patients; treatment of anemia in cancer patients on chemotherapy;
and reduction of allogenic blood transfusions in surgery patients.
The FDA-approved indications for darbepoetin alfa are for the treatment of anemia, associated with chronic
renal failure, including patients on dialysis and patients not on dialysis and for treatment of anemia in patients
with nonmyeloid malignancies where anemia is due to the effect of concomitantly administered
chemotherapy.
ESAs TREATED AS A CLASS
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 LCD does not distinguish differences for on or offlabel
indications and contraindications. Several off-label uses are well-accepted clinically, as indicated by
inclusion in the USP-DI and similar compendia. However, a contraindication for either ESA is binding on
both.
NEW FDA WARNINGS ON ESA USAGE
In March 2007, the FDA issued new warnings against target hemoglobin 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.
In November, 2007, the FDA warned that in cancer patients target hemoglobin levels above 12 g/dl were
directly linked to higher mortality, and it was uncertain whether target hemoglobin levels between 10 and 12
g/dl were also associated with higher mortality. FDA targets for chronic renal failure patients were revised to
10-12 g/dl (30-36% hematocrit).
DISTINGUISHING PER-DIALYSIS ESA USE FROM THE ESA/DIALYSIS BENEFIT
LCD Information
LCD ID Number
This Part B LCD governs only non-dialysis uses for ESAs, when the ESA is medically necessary, "incidentto"
a physician, and not self-administered. (ESAs in dialysis patients are covered by separate Federal
regulations under which there is a unique ESA/ESRD payment structure, self-administration may be allowed,
and the ESA treatment need not be “incident-to” a physician. Any reference here to the dialysis use of ESAs
in End Stage Renal Disease (ESRD) is only to show the distinction between ESRD and non-ESRD uses.
Medicare defines ESRD as permanent advanced kidney failure in which patients are undergoing maintenance
dialysis. Patients with chronic renal failure (partial renal failure) not yet requiring dialysis may be referred to
as "pre-dialysis" patients, or "pre-ESRD." ESA for such patients falls under this Part B LCD rather than the
dialysis benefit.
ESAs are not eligible for Part B coverage when:
• The ESA is administered by a dialysis facility as part of the Part A ESRD benefit (including the selfinjection
method which is part of the dialysis benefit rules).
• The ESA is part of a home health benefit.
• The ESA is self-administered (i.e. self-injected).
NATIONAL COVERAGE DETERMINATION: ESA IN CANCER PATIENTS
ESAs are regulated by a National Coverage Decision in patients with cancer. Such patients fall outside this
LCD. In brief, per NCD, ESAs are not covered in patients with “anemia of cancer” not caused by
chemotherapy. ESAs are covered in patients with anemia of chemotherapy, if the hemoglobin is below 10
g/dl, and the patient is no more than 8 weeks from the last dose of chemotherapy in a series. The text of the
ESA/cancer NCD is provided in the Appendix for reference.
GENERAL GUIDANCE FOR ANEMIA WORKUP
The patient must have a work-up that directly or indirectly validates that hematopoietic substrates including
iron, B 12, and folic acid are present in adequate amounts to fully support erythropoiesis. These tests should
be done as needed for treatment of anemia due to cancer chemotherapy. Serum ferritin typically is measured
when initiating chemotherapy and dialysis. Iron is replaced as needed. Treatable toxicity such as due to
aluminum should be ruled out when appropriate. In ESA-treated patients, intravenous iron solutions are
covered when clinically necessary to support effective and efficient use of ESAs.
The patient must have a bone marrow potentially responsive to erythropoietin analog treatment. For all
indications, documentation of a significant response is required to support ongoing use (i.e., reasonable
and necessary).
For most indications and typical weights, the usual dose of epoetin alfa is up to 40,000 units weekly, given in
single or divided doses until the therapeutic target is reached. In resistant patients, typically the maximum
dose is 60,000 units per week given in a single or divided dose. However, occasionally epoetin alfa is
administered on weight-based dosing, in which case these patients may require higher doses based on weight,
up to 300 units/kg per dose, or up to 900 units/kg per week. The stable dose must be no greater than the
minimally effective dose to adequately treat the patient’s condition.
Dosing for darbepoetin should be titrated to not exceed a target hemoglobin concentration of 12 grams/dl.
Sufficient time (up to 2-6 weeks) should be allowed to determine a patient's responsiveness to a dosage
before adjusting the dose.
LCD Information
LCD ID Number
SPECIFIC DISORDERS FALLING UNDER THIS LCD:
Renal Patients Not on Dialysis: Pre-ESRD/Chronic Renal Failure (CRF):
ESAs are covered for patients with anemia due to CRF who are not yet on the separate ESRD dialysis
benefit. In this patient category, the serum creatinine is greater than 2.0 mg/dl or the creatinine clearance by
any standard method is less than 45ml/min. Prior to and during erythropoietin analog therapy, the patient's
iron stores should be evaluated according to National Kidney Foundation Guidelines. If the transferrin
saturation is less than 20%, and the serum ferritin is less than 100ng/dl, appropriate iron supplementation
should be administered.
Anemia due to Chronic Illness (other than CRF), Bone Marrow Dysfunctions, AZT Toxicity in HIVInfected
Patients, or Toxic Effects of Other Life-Sustaining Drugs:
Erythropoietin analogs are covered for the treatment of anemia of nonhemorrhagic chronic disease that
suppresses erythropoietin production or bone marrow response. Examples include rheumatoid arthritis,
inflammatory bowel disease, myelodysplastic syndromes (MDS), and chronic anemia due to bone marrow
hypofunction from prior radiation.
As a prerequisite, the patient must be (1) transfusion-dependent, or (2) symptomatic from the anemia,
documented by such impairments as moderate to severe exercise intolerance, inability to perform activities of
daily living, tachycardia or shortness of breath with minimal activity.
Erythropoietin analogs are covered for the treatment of anemia associated with the toxic effects of necessary
life-sustaining drugs, such as zidovudine (AZT) toxicity in an HIV-infected patient, Rebetron™ (Rebetrol®
plus Intron®) toxicity in a hepatitis C infected patient, Revlimid toxicity, or Imuran® toxicity in a patient
with a transplanted organ, when scientific evidence supports such use.
1. The pretreatment hematocrit (or comparable hemoglobin level) must be below 36%. Exceptions, in the
presence of severe comorbidities, will be rare (39% or 13 grams when severe comorbidity is present).
2. Coverage beyond eight (8) weeks of therapy requires an increase in the hemoglobin of at least 1 gm/dl and
a decrease in symptoms of anemia.
3. Coverage beyond sixteen (16) weeks of therapy requires a decrease in symptoms of anemia and one of the
following:
• A decrease in transfusion requirements; or
• An increase in the hemoglobin of at least 2 gm/dl above pretreatment levels, or an absolute level of
12.0 gm/dl, whichever is less.
4. For the AZT toxicity and MDS indications, the pretreatment endogenous erythropoietin level must be less
than 500 micro units/ml.
Preoperative Use:
LCD Information
LCD ID Number
Medicare defines covered and non-covered types of pre-operative use. ESAs are covered for the treatment of
anemic patients (hemoglobin > 10 13 grams/dl) scheduled to undergo elective noncardiac, nonvascular
surgery (the FDA label for pre-surgical use) to reduce the need for allogenic blood transfusions. The patient
will be at high risk for perioperative transfusions with significant anticipated blood loss (two units of blood or
more). Section 50.5.2 states that the patients “are not a candidate for autologous blood transfusion” and
appears to consider preparation for autologous transfusion as a non-covered, preventative use. Note however
that ESA might be covered due to anemia of chronic disease (without regard to the possible surgery or
donation). The patient should receive iron supplementation no later than the beginning of ESA treatment, and
throughout the course of therapy. The dose must follow the FDA label for this indication. Most pre-surgical
ESA protocols require anti-thrombotic prophylaxis.
Conditions Not Covered:
Other anemias that are not covered include those due to hemolysis, nutritional deficiencies, untreated
underlying infections, refractory anemia such as thalassemia or sickle cell disease, cofactor deficiencies,
hemorrhage, known sensitivity to Albumin, hypersensitivity to mammalian cell-derived products,
uncontrolled hypertension, or most patients with GI bleeding.
Anemia of cancer is defined as patients with active cancer (e.g. in FDA registrational trials for such an
indication), and without current or recent chemotherapy. In those patients with cancer and a additional clearly
qualifying chronic disease condition (in particular ESRD or locally defined coverage, see above), anemia
treatment may fall under the coverage category. Because the convincing negative trials for "cancer of
anemia" these patients' poor response as a group have been the subject of explicit manufacturer and FDA
warnings, and non-coverage NCD. Similar patients should not be routinely coded with alternative diagnoses
like “anemia of bone marrow failure.”
Coverage Topic
Chemotherapy (Inpatient)
Chemotherapy (Outpatient)
Dialysis (Kidney) Inpatient
Dialysis (Kidney) Outpatient
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.
999x Not Applicable
Revenue Codes:
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.
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.
99999 Not Applicable
CPT/HCPCS Codes
For darbopoetin alfa, per 1 mcg, report J0881. Trade names include Aranesp.
For epoetin or erythropoietin, per 1000 units, report J0885. Trade names include Epogen, Procrit, Eprex.
HCPCS codes J0881 and J0885 include all non-dialysis uses. For example, anemia in patients undergoing
chemotherapy or anemia secondary to chronic renal failure in a non-dialysis patient.
J0881 INJECTION, DARBEPOETIN ALFA, 1
MICROGRAM (NON-ESRD USE)
J0885 INJECTION, EPOETIN ALFA, (FOR NON-ESRD
USE), 1000 UNITS
ICD-9 Codes that Support Medical Necessity
For the conditions identified below requiring a secondary (additional) diagnosis, both the primary and
secondary ICD-9-CM codes must be submitted on the same claim to justify medical necessity.
Anemia Associated with CRF Without Dialysis (pre-dialysis)(J0881, J0885)
Primary Diagnoses:
285.21 ANEMIA IN CHRONIC KIDNEY DISEASE
ICD-9-CM code 585 is valid prior to 10/1/2005.
Secondary Diagnoses:
585.1 - 585.5 CHRONIC KIDNEY DISEASE, STAGE I -
CHRONIC KIDNEY DISEASE, STAGE V
585.9 CHRONIC KIDNEY DISEASE, UNSPECIFIED
Anemia of Cancer Chemotherapy (J0881, J0885)
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.
Primary Diagnoses:
199.2 MALIGNANT NEOPLASM ASSOCIATED WITH
TRANSPLANT ORGAN
203.00 MULTIPLE MYELOMA, WITHOUT MENTION OF
HAVING ACHIEVED REMISSION
203.02 MULTIPLE MYELOMA, IN RELAPSE
203.10 PLASMA CELL LEUKEMIA, WITHOUT MENTION OF
HAVING ACHIEVED REMISSION
203.12 PLASMA CELL LEUKEMIA, IN RELAPSE
203.80 OTHER IMMUNOPROLIFERATIVE NEOPLASMS,
WITHOUT MENTION OF HAVING ACHIEVED
REMISSION
203.82 OTHER IMMUNOPROLIFERATIVE NEOPLASMS, IN
RELAPSE
204.00 ACUTE LYMPHOID LEUKEMIA, WITHOUT MENTION
OF HAVING ACHIEVED REMISSION
204.01 LYMPHOID LEUKEMIA ACUTE IN REMISSION
204.02 ACUTE LYMPHOID LEUKEMIA, IN RELAPSE
204.10 CHRONIC LYMPHOID LEUKEMIA, WITHOUT
MENTION OF HAVING ACHIEVED REMISSION
204.11 LYMPHOID LEUKEMIA CHRONIC IN REMISSION
204.12 CHRONIC LYMPHOID LEUKEMIA, IN RELAPSE
204.20 SUBACUTE LYMPHOID LEUKEMIA, WITHOUT
MENTION OF HAVING ACHIEVED REMISSION
204.21 LYMPHOID LEUKEMIA SUBACUTE IN REMISSION
204.22 SUBACUTE LYMPHOID LEUKEMIA, IN RELAPSE
204.80 OTHER LYMPHOID LEUKEMIA, WITHOUT MENTION
OF HAVING ACHIEVED REMISSION
204.81 OTHER LYMPHOID LEUKEMIA IN REMISSION
204.82 OTHER LYMPHOID LEUKEMIA, IN RELAPSE
204.90 UNSPECIFIED LYMPHOID LEUKEMIA, WITHOUT
MENTION OF HAVING ACHIEVED REMISSION
204.91 UNSPECIFIED LYMPHOID LEUKEMIA IN REMISSION
204.92 UNSPECIFIED LYMPHOID LEUKEMIA, IN RELAPSE
209.00
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.
MALIGNANT CARCINOID TUMOR OF THE SMALL
INTESTINE, UNSPECIFIED PORTION
209.01 MALIGNANT CARCINOID TUMOR OF THE
DUODENUM
209.02 MALIGNANT CARCINOID TUMOR OF THE JEJUNUM
209.03 MALIGNANT CARCINOID TUMOR OF THE ILEUM
209.10 MALIGNANT CARCINOID TUMOR OF THE LARGE
INTESTINE, UNSPECIFIED PORTION
209.11 MALIGNANT CARCINOID TUMOR OF THE
APPENDIX
209.12 MALIGNANT CARCINOID TUMOR OF THE CECUM
209.13 MALIGNANT CARCINOID TUMOR OF THE
ASCENDING COLON
209.14 MALIGNANT CARCINOID TUMOR OF THE
TRANSVERSE COLON
209.15 MALIGNANT CARCINOID TUMOR OF THE
DESCENDING COLON
209.16 MALIGNANT CARCINOID TUMOR OF THE SIGMOID
COLON
209.17 MALIGNANT CARCINOID TUMOR OF THE RECTUM
209.20 MALIGNANT CARCINOID TUMOR OF UNKNOWN
PRIMARY SITE
209.21 MALIGNANT CARCINOID TUMOR OF THE
BRONCHUS AND LUNG
209.22 MALIGNANT CARCINOID TUMOR OF THE THYMUS
209.24 MALIGNANT CARCINOID TUMOR OF THE KIDNEY
209.25 MALIGNANT CARCINOID TUMOR OF FOREGUT,
NOT OTHERWISE SPECIFIED
209.26 MALIGNANT CARCINOID TUMOR OF MIDGUT, NOT
OTHERWISE SPECIFIED
209.27 MALIGNANT CARCINOID TUMOR OF HINDGUT,
NOT OTHERWISE SPECIFIED
209.29 MALIGNANT CARCINOID TUMOR OF OTHER SITES
209.30 MALIGNANT POORLY DIFFERENTIATED
NEUROENDOCRINE CARCINOMA, ANY SITE
284.81 RED CELL APLASIA (ACQUIRED) (ADULT) (WITH
THYMOMA)
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.
284.89 OTHER SPECIFIED APLASTIC ANEMIAS
Secondary Diagnoses:
990 EFFECTS OF RADIATION UNSPECIFIED
E930.7 ANTINEOPLASTIC ANTIBIOTICS CAUSING
ADVERSE EFFECTS IN THERAPEUTIC USE
E933.1 ANTINEOPLASTIC AND IMMUNOSUPPRESSIVE
DRUGS CAUSING ADVERSE EFFECTS IN
THERAPEUTIC USE
In addition, providers may add the underlying cancer diagnosis under treatment:
140.0 MALIGNANT NEOPLASM OF UPPER LIP
VERMILION BORDER
230.0 - 239.0 CARCINOMA IN SITU OF LIP ORAL CAVITY AND
PHARYNX - NEOPLASM OF UNSPECIFIED NATURE
OF DIGESTIVE SYSTEM
273.3 MACROGLOBULINEMIA
ICD-9-CM code 238.7 is valid prior to 10/1/2006.
Anemia of Bone Marrow Dysfunctions Not Under Treatment with Chemotherapy (J0881, J0885)
Primary Diagnoses: (No secondary diagnosis is required.)
203.00 MULTIPLE MYELOMA, WITHOUT MENTION OF
HAVING ACHIEVED REMISSION
238.71 - 238.76 ESSENTIAL THROMBOCYTHEMIA -
MYELOFIBROSIS WITH MYELOID METAPLASIA
238.79 OTHER LYMPHATIC AND HEMATOPOIETIC
TISSUES
273.3 MACROGLOBULINEMIA
284.81* RED CELL APLASIA (ACQUIRED) (ADULT) (WITH
THYMOMA)
284.89* OTHER SPECIFIED APLASTIC ANEMIAS
285.0 SIDEROBLASTIC ANEMIA
289.89 OTHER SPECIFIED DISEASES OF BLOOD AND
BLOOD-FORMING ORGANS
*Note: Only in this case can diagnosis code 284.8 be billed without a secondary diagnosis.
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.
Anemia of chronic illness (J0881, J0885)
Primary Diagnoses:
285.29* ANEMIA OF OTHER CHRONIC DISEASE
* Secondary Diagnoses: Various
Anemia of AZT in HIV-Infected Patients (J0881, J0885)
Primary Diagnoses:
284.81 RED CELL APLASIA (ACQUIRED) (ADULT)
(WITH THYMOMA)
284.89 OTHER SPECIFIED APLASTIC ANEMIAS
Secondary Diagnoses:
042 HUMAN IMMUNODEFICIENCY VIRUS (HIV)
DISEASE
Primary Diagnoses:
285.8 OTHER SPECIFIED ANEMIAS
Secondary Diagnoses:
042 HUMAN IMMUNODEFICIENCY VIRUS (HIV)
DISEASE
Primary Diagnoses:
285.9 ANEMIA UNSPECIFIED
Secondary Diagnoses:
042 HUMAN IMMUNODEFICIENCY VIRUS (HIV)
DISEASE
Anemia of Toxic Effect of Life-Sustaining Drugs (J0881, J0885)
Primary Diagnoses:
284.81 RED CELL APLASIA (ACQUIRED) (ADULT)
(WITH THYMOMA)
284.89 OTHER SPECIFIED APLASTIC ANEMIAS
Secondary Diagnoses:
995.20 - 995.23 UNSPECIFIED ADVERSE EFFECT OF
UNSPECIFIED DRUG, MEDICINAL AND
BIOLOGICAL SUBSTANCE - UNSPECIFIED
ADVERSE EFFECT OF INSULIN
995.27 OTHER DRUG ALLERGY
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.
995.29 UNSPECIFIED ADVERSE EFFECT OF OTHER
DRUG, MEDICINAL AND BIOLOGICAL
SUBSTANCE
Preoperative Use for Anemic Patients (J0881, J0885)
Primary Diagnoses:
Note: ICD-9-CM code 284.9, Aplastic anemia, unspecified, will no longer be accepted for
preoperative use.
285.29* ANEMIA OF OTHER CHRONIC DISEASE
*Secondary Diagnoses: Various
Diagnoses that Support Medical Necessity
Any diagnosis consistent with those specified in the Indications and Limitations of Coverage and/or Medical
Necessity section, or the ICD-9-CM descriptors in the list of ICD-9-CM Codes That Support Medical
Necessity section.
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.
ICD-9 Codes that DO NOT Support Medical Necessity
For anemia of chemotherapy, use 284.8, not 285.22. ICD-9-CM code 284.8 includes anemia induced by
drugs, such as chemotherapy.
205.00 - 205.92 ACUTE MYELOID LEUKEMIA, WITHOUT
MENTION OF HAVING ACHIEVED REMISSION -
UNSPECIFIED MYELOID LEUKEMIA, IN RELAPSE
206.00 - 206.92 ACUTE MONOCYTIC LEUKEMIA, WITHOUT
MENTION OF HAVING ACHIEVED REMISSION -
UNSPECIFIED MONOCYTIC LEUKEMIA, IN
RELAPSE
207.00 - 207.82 ACUTE ERYTHREMIA AND
ERYTHROLEUKEMIA, WITHOUT MENTION OF
HAVING ACHIEVED REMISSION - OTHER
SPECIFIED LEUKEMIA, IN RELAPSE
208.00 - 208.92 ACUTE LEUKEMIA OF UNSPECIFIED CELL TYPE,
WITHOUT MENTION OF HAVING ACHIEVED
REMISSION - UNSPECIFIED LEUKEMIA, IN
RELAPSE
209.40 - 209.69 BENIGN CARCINOID TUMOR OF THE SMALL
INTESTINE, UNSPECIFIED PORTION - BENIGN
CARCINOID TUMOR OF OTHER SITES
285.22 ANEMIA IN NEOPLASTIC DISEASE
ICD-9 Codes that DO NOT Support Medical Necessity Asterisk Explanation
Diagnoses that DO NOT Support Medical Necessity
Any diagnosis inconsistent with the Indications and Limitations of Coverage and/or Medical Necessity
section, the ICD-9-CM descriptors in the ICD-9-CM Codes That Support Medical Necessity section.
General Information
Documentation Requirements
When applicable, a reasonable and appropriate work-up must show an anemia and that it is potentially
responsive to an erythropoietin analog. The physician who administers the erythropoietin analog must
maintain this information in the patient's medical record.
General Information
Documentation Requirements
The record must be legible, clearly indicate the initial need for the treatment, include the relevant laboratory
results that support the treatment, and when applicable, prove the ongoing benefit.
The initial treatment record for the treatment of anemia must include the following documentation:
1. The diagnosis;
2. The date and results of the most recent hematocrit (HCT) and/or hemoglobin (Hgb) level, within one week
prior to initiation of therapy;
3. The amount and route of administration; and
4. The patient's current weight in kilograms.
Subsequent treatment records must include:
1. The diagnosis;
2. The date and results of the most recent hematocrit and/or hemoglobin level, within four weeks, prior to
administration;
3. The amount and route of administration;
4. Expected duration of treatment; and
5. The patient's response to therapy to date.
For patients with renal failure, also include the date and results of the patient's most recent serum creatinine
or estimated creatinine clearance, within the last month, prior to the initiation of the erythropoietin analog
therapy.
The information contained in documentation requirements for the initial and subsequent treatments with
erythropoietin analog must be documented clearly in the patient's medical record and must be available to the
contractor upon request.
An epoetin alfa dose in excess of 900 units/Kg/week or any dose given regularly for more than 8 or 16 weeks
requires documentation in the medical records that proves the benefit of the higher dose or ongoing
treatment. This documentation must include, when applicable, a pretreatment measure of the anemia,
erythropoietin level, iron and other cofactor levels, transfusion requirements, and validation of the ongoing
benefit of the treatment.
When a severe comorbid condition justifies a target hematocrit above 36%, the documentation must show
that a lower hematocrit complicates the comorbidity (e.g., the angina is uncontrolled at a hematocrit of 36%).
The documentation need not to be submitted with the claim but must be available upon request.
Appendices
[NCD on ESA use related to cancer, CAG Decision Memo 00383N, 7/30/2007)
CMS has determined that there is sufficient evidence to conclude that erythropoiesis stimulating agent (ESA)
treatment is NOT reasonable and necessary for beneficiaries with certain clinical conditions, either because
of a deleterious effect of the ESA on their underlying disease or because the underlying disease increases
their risk of adverse effects related to ESA use. These conditions include:
General Information
Documentation Requirements
1. Any anemia in cancer or cancer treatment patients due to folate deficiency, B-12 deficiency, iron
deficiency, hemolysis, bleeding, or bone marrow fibrosis;
2. The anemia associated with the treatment of acute and chronic myelogenous leukemias (CML,
AML), or erythroid cancers;
3. The anemia of cancer not related to cancer treatment;
4. Any anemia associated only with radiotherapy;
5. Prophylactic use to prevent chemotherapy-induced anemia;
6. Prophylactic use to reduce tumor hypoxia;
7. Patients with erythropoietin-type resistance due to neutralizing antibodies; and
8. Anemia due to cancer treatment if patients have uncontrolled hypertension.
We have also determined that ESA treatment for the anemia secondary to myelosuppressive anticancer
chemotherapy in solid tumors, multiple myeloma, lymphoma and lymphocytic leukemia is ONLY reasonable
and necessary under the following specified conditions:
General Information
Documentation Requirements
1. The hemoglobin level immediately prior to initiation or maintenance of ESA treatment is < 10 g/dL
(or the hematocrit is < 30%).
2. The starting dose for ESA treatment is the recommended FDA label starting dose, no more than
150 U/kg/three times weekly for epoetin and 2.25 mcg/kg/weekly for darbepoetin alpha. Equivalent
doses may be given over other approved time periods.
3. Maintenance of ESA therapy is the starting dose if the hemoglobin level remains below 10 g/dL (or
hematocrit is < 30%) 4 weeks after initiation of therapy and the rise in hemoglobin is > 1g/dL
(hematocrit > 3%).
4. For patients whose hemoglobin rises <1 g/dl (hematocrit rise <3%) compared to pretreatment
baseline over 4 weeks of treatment and whose hemoglobin level remains <10 g/dL after the 4 weeks
of treatment (or the hematocrit is <30%), the recommended FDA label starting dose may be increased
once by 25%. Continued use of the drug is not reasonable and necessary if the hemoglobin rises <1
g/dl (hematocrit rise <3 %) compared to pretreatment baseline by 8 weeks of treatment.
5. Continued administration of the drug is not reasonable and necessary if there is a rapid rise in
hemoglobin > 1 g/dl (hematocrit > 3%) over 2 weeks of treatment unless the hemoglobin remains
below or subsequently falls to < 10 g/dL (or the hematocrit is < 30%). Continuation and reinstitution
of ESA therapy must include a dose reduction of 25% from the previously administered dose.
6. ESA treatment duration for each course of chemotherapy includes the 8 weeks following the final
dose of myelosuppressive chemotherapy in a chemotherapy regimen.
Local Medicare contractors may continue to make reasonable and necessary determinations on all uses of
ESAs that are not determined by NCD.
Utilization Guidelines
Clinicians should observe for patients who are simply ESA-nonresponders or who have inadequate iron or
other supporting factors. There are accepted, several dose and frequency alternatives for ESAs which change
from time to time with new protocols, and may vary depending on the clinical circumstances and patient
response.
Doses of epoetin alfa in excess of 900 units/kg/week, more frequent than three times weekly, or continuous
use in excess of 8 or 16 weeks may require documentation review before payment is made.
Doses of darbepoetin alfa in the treatment of ESRD or CRF exceeding 200 mcg/week are rarely reasonable
and necessary. The medical justification for doses exceeding these amounts should be documented in the
patient's medical record and made available for review upon request.
General Information
Documentation Requirements
Medical justification for doses of darbepoetin alfa for anemia due to chemotherapy for non-myeloid
malignancy exceeding 1.5-2.25 mcg/kg/week or 3-5 mcg/kg every two weeks must be documented in the
patient's medical record and made available for review upon request. An additional guideline is 500 mcg q 3
weeks.
Patients should have a hematocrit of less than or equal to 36% on subsequent claims. Claims with hematocrits
> 36.0% and above or hemoglobin > 12.0 grams should be submitted with documentation to support the
medical necessity for continued therapy.
Sources of Information and Basis for Decision
Other contractors' LCDs, including Noridian and others.
Contractor Medical Director; CMS Contractor Medical Director committees and conference calls.
Amgen.com and other websites (e.g. www.Aranesp.com ; www.procrit.com )
FDA Warning Alert: Erthropoetin Stimulating Agents ESAs, updated 11/16/2006, 2/16/2007, and 3/9/2007.
www.fda.gov.
National Guideline Clearinghouse at http://www.guideline.gov/body_home_nf.aspview=home
National Kidney Foundation Dialysis Outcomes Quality Initiative (DOQI). American Journal of Kidney
Disease. 1997;30:S192-S240, Available at: http://www.kidney.org/professional/doqi/index.cfm
National Kidney Foundation Kidney Dialysis Outcomes Quality Initiative 2000 Update. (K/DOQI).
American Journal of Kidney Disease. 2001;37. S182-S238, 2001
NCCN Practice Guidelines in Oncology: Cancer and Chemotherapy-related anemia. (revision 2-2007).
Available at: www.nccn.org.
NKF-K/DOQI Clinical Practice Guideline. Available at:
http://www.kidney.org/professionals/doqi/guidelines/doqi_uptoc.html#an
Birgegard G, Hallgren R, Caro J. Serum erythropoietin in rheumatoid arthritis and other inflammatory
arthritides: relationship to anaemia and the effect of anti-inflammatory treatment. British Journal of
Haematology. Apr 1987;654):479-83.
Demetri. et al. Quality-of-Life Benefit in Chemotherapy Patients Treated with Epoetin Alfa Is Independent of
Disease Response of Tumor Type: Results From a Prospective Community Oncology Study. Journal of
Clinical Oncology. 1998;16:3412-25.
FDA, Oncologic Drugs Advisory Group. Adverse events discussed by the FDA Oncologic Drugs Advisory
Committee. May 2004. Available at: (http://www.fda.gov/ohrms/dockets/AC/04/briefing/4037b2_04.pdf)
General Information
Documentation Requirements
Glaspy. et al. Impact of Therapy With Epoetin Alfa on Clinical Outcomes in Patients With Nonmyeloid
Malignancies During Cancer Chemotherapy in Community Oncology Practice. Journal of Clinical Oncology.
1997;15:1218-34.
Hellstrom-Lindbergh. et al. Erythroid response to treatment with G-CSF plus erythropoietin for the anemia of
patients with myelodysplastic syndromes; proposal for a predictive model. British Journal of Haematology.
1997;99(2):344-51.
Hellstrom-Lindbergh. et al. Treatment of anemia in Myelodysplastic Syndromes with Granulocyte Colony-
Stimulating Factor Plus Erythropoietin: Results from a Randomized Phase II Study and Long-Term Follow-
Up of 71 Patients. Blood. 1998;92:68-75.
Hellstrom-Lindberg. et al. Achievements in Understanding and treatment of Myelodysplastic Syndromes.
Hematology Am Soc Hematol Educ Program. 2000:110-132. Available at:
http://asheducationbook.hematologylibrary.org/cgi/reprint/2000/1/110.
Italian Cooperative Study Group. rHuEpo in Myelodysplastic Syndromes; A randomized double-blind
placebo-controlled study with subcutaneous recombinant human erythropoietin in patients with low-risk
myelodysplastic syndromes. British Journal of Haematology. 1998;103:1070-74.
Knight K. Prevalence and outcomes of anemia in cancer: a systematic review of the literature. Am J Med.
2004;117S1:11-26.
Mancini DM. et al. Effect of erythropoietin on exercise capacity in patients with moderate to severe chronic
heart failure. Circulation. 2003;107:294.
National Kidney Foundation (NKF)-Dialysis Outcomes Initiative (DOQI) Anemia Management Clinical
Practice Guideline 4 and 7A.
Negrin RS. et al. Maintenance Treatment of Anemia of Myelodysplastic Syndromes with Recombinant
Human Granulocyte Colony-Stimulating Factor and Erythropoietin: Evidence for In Vivo Synergy. Blood.
May 1996;87(10):4076-81.
Nielsen OJ. et al. The Secretory Erythropoietin Response in Patients with Multiple Myeloma and
Waldenstrom’s Macroglobulinaemia. Scandinavian Journal of Clinical Laboratory Investigation. Nov.
1990;697-703.
O’Meara E. et al. Clinical Correlates and Consequences of Anemia in a Broad Spectrum of Patients With
Heart Failure: Results of the Candesartan in Heart Failure: Assessment of Reduction in Mortality and
Morbidity (CHARM) Program. Circulation. 2006;113:986-94.
Peeters HR. et al. Recombinant human erythropoietin improves health-related quality of life in patients with
rheumatoid arthritis and anaemia of chronic disease; utility measures correlate strongly with disease activity
measures. Rheumatol Int. 1999;18(5-6):201-6.
Rizzo. et al. Use of Epoetin in Patients With Cancer: Evidence-Based Clinical Practice Guidelines of the
American Society of Clinical Oncology and the American Society of Hematology. Journal of Clinical
Oncology. 2002;20:4083-107. “There are no published high-quality studies to support [Epoetin] use for
anemia in other hematologic malignancies [than low risk myelodysplasia] in the absence of chemotherapy.”
Rose E, Abels R, Nelson R, McCullough D, Lessin L. The use of r-HuEpo in the treatment of anaemia related
to myelodysplasia (MDS). British Journal of Haematology. 1995;89:831-37.
General Information
Documentation Requirements
Smith R.E., JR. Tchekmedyian N.S. et al. "A dose-and schedule-finding study of darbepoetin alpha for the
treatment of chronic anaemia of cancer." Br J Cancer. 2003;88(12):1851-8.
Stasi R. et al. Management o0f cancer-related anemia with erythropoetic agents: Doubts, certainties,
concerns. The Oncologist. 2005;10:539-54.
Swaak AJ. et al. Recombinant human erythropoietin (r-hu-EPO) treatment in patients with rheumatoid
arthritis and anaemia of chronic disease. Ann Rheum Dis. Oct. 1996;55(10):739-44.
Tang YD. et al. Anemia in heart failure (review). Circulation. 2006;113:2454-61.
Vansteenkiste J. Rossi G. et al. "Darbepoetin alfa: a new approach to the treatment of chemotherapy-induced
anemia." Expert Opin Biol Ther. 2003;3(3):501-8.
Weiss G. Pathogenesis and treatment of anemia of chronic disease. Blood Reviews. 2002;16:87-96.
Weiss G. Anemia of chronic disease. NEJM. 2005.352:1011-23.
Wilson A. et al. 2004. Prevalence and outcomes of anemia in rheumatoid arthritis: a systematic review of the
literature. Am J Med. 2004;116-S1:50-7.
NOTE: Some of the websites used as resources for development of this policy may no longer be available.
Advisory Committee Meeting Notes
This policy does not reflect the sole opinion of the contractor or Contractor Medical Director. Although the
final decision rests with the contractor, this policy was developed in cooperation with advisory groups, which
include representatives from the affected provider community.
Contractor Advisory Committee meeting dates:
California -
Hawaii -
Nevada -
Start Date of Comment Period
End Date of Comment Period
Start Date of Notice Period
06/16/2008
General Information
Documentation Requirements
Revision History Number
Revision #1, 09/02/2008
Revision History Explanation
Revision #1, 09/02/2008
This LCD is being revised due to the annual FY2009 ICD-9-CM code update. Under Anemia of Cancer
Chemotherapy (J0881, J0885) the following codes were added: 203.02, 203.12, 230.82, 238.77. The
following codes were added due to consolidation with Part A, A/BMAC of Palmetto: 199.2, 203.00, 203.10,
203.80, 204.00, 204.01, 204.02, 204.10, 204.11, 204.12, 204.20, 204.21, 204.22, 204.80, 204.81, 204.82,
204.90, 204.91, 204.92, 209.00, 209.01, 209.02, 209.03, 209.10, 209.11, 209.12, 209.13, 209.14, 209.15,
209.16, 209.17, 209.20, 209.21, 209.22, 209.24, 209.25, 209.26, 209.27, 209.29, 209.30. ICD-9-CM Codes
that were revised were 203.00, 203.00 and 203.82. Under ICD-9 Codes that DO NOT support Medical
Necessity the following ICD-9 codes were added: 205-205.91, 206.00-206.91, 207.00-207.81, 208.00-208.01
and 209.40-209.69. "Sources of Information and Basis for Decision" references were placed in the AMA
citation format. This revision will become effective 10/01/2008.
Revision #1, 08/04/2008
This LCD is being revised to add Bill Type 999X because the automated system transcription process was
incomplete.
08/10/2008 - This policy was updated by the ICD-9 2008-2009 Annual Update.
Reason for Change
ICD9 Addition/Deletion
Maintenance (annual review with new changes, formatting, etc.)
Last Reviewed On Date
09/16/2008
Related Documents
This LCD has no Related Documents.
LCD Attachments
There are no attachments for this LCD.
Other Versions
Updated on 07/26/2008 with effective dates 09/02/2008 - 09/30/2008
Updated on 06/08/2008 with effective dates 09/02/2008 - N/A

Any providers having a problem with receiving EOMBs from Palmetto can send or fax Palmetto a letter on their letterhead that says to turn them back on to paper remits.
The letter will need to contain the providers PTAN, NPI, provider name and signature.
Fax the letters to 803-935-0008.

Catalina Jovane'
Palmetto GBA-J1 Region
Medicare Part B Ombudsman-CA & NV (AG-820) Provider Outreach and Education

J1 A/B MAC Transition is Complete!
http://www.palmettogba.com/palmetto/j1.nsf/DocsCat/J1%20AB%20MAC%20Transition%20is%20Complete!?opendocument

The J1 A/B MAC transition has successfully been completed for all three segments! The implementation information announcement line, 888-318-7246, will be discontinued on Wednesday, September 3, 2008.

Applies to:
Part A Transition: EDI
Part A Transition: General
Part B Transition: EDI
Part B Transition: General

Attention NHIC Providers - J1 Overpayment Refund Form
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NHIC will soon no longer be processing incoming checks. All checks received by NHIC will be transferred to Palmetto
GBA. In order to expedite processing of incoming checks and to avoid unnecessary withholdings, Palmetto GBA would
like to encourage all NHIC providers to begin sending checks to Palmetto GBA effective immediately.

Applies to:
Part B Transition: General
----------

NHIC Customers (Segment 3): The J1 Part B Go Live date is September 2, 2008!
http://www.palmettogba.com/palmetto/j1.nsf/DocsCat/NHIC%20Customers%20(Segment%203)%3A
%20The%20J1%20Part%20B%20Go%20Live%20date%20is%20September%202%2C%202008!?
opendocument

Attention NHIC Customers (Segment 3):    12 days and counting. Are you
ready ?!?   If you currently receive electronic payments from your current
contractor and have not submitted an updated CMS-588 Form to Palmetto GBA, please do so immediately.

Applies to:
Part B Transition: EDI
----------

Submission of Services - All Providers
http://www.palmettogba.com/palmetto/j1.nsf/DocsCat/Submission%20of%20Services%20-%20All%20Providers?opendocument

This is to advise all providers that it is the responsibility of the provider submitting a service for payment to ensure that the code submitted correctly identifies the service performed.  This is of the utmost importance when submitting Medicare services. Your documentation must support the service reported.  Any service should be documented during, or as soon as practicable after it is provided in order to maintain an accurate medical record.

Applies to: