CMS Manual System
Department of Health & Human
Services (DHHS)
Pub 100-04 Medicare Claims Processing
Centers for Medicare & Medicaid
Services (CMS)
Transmittal 1413 Date: JANUARY 14, 2008
Change Request 5818
SUBJECT: Erythropoiesis Stimulating Agents (ESAs) in Cancer and Related Neoplastic Conditions
I. SUMMARY OF CHANGES: CMS has determined that ESA treatment is reasonable and necessary for
anemia secondary to myelosuppressive anticancer chemotherapy in solid tumors, multiple myeloma,
lymphoma and lymphocytic leukemia under specified conditions. CMS has also determined that 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.
NEW / REVISED MATERIAL
EFFECTIVE DATE: JULY 30, 2007
IMPLEMENTATION DATE: APRIL 7, 2008
Disclaimer for manual changes only: The revision date and transmittal number apply only to red
italicized material. Any other material was previously published and remains unchanged. However, if this
revision contains a table of contents, you will receive the new/revised information only, and not the entire
table of contents.
II. CHANGES IN MANUAL INSTRUCTIONS: (N/A if manual is not updated)
R=REVISED, N=NEW, D=DELETED
R/N/D CHAPTER / SECTION / SUBSECTION / TITLE
R
17/Table of Contents
N
17/80.12/Claims Processing Rules for ESAs Administered to
Cancer Patients for Anti-Anemia Therapy
III. FUNDING:
SECTION A: For Fiscal Intermediaries and Carriers:
No additional funding will be provided by CMS; contractor activities are to be carried out within their
operating budgets.
SECTION B: For Medicare Administrative Contractors (MACs):
The Medicare administrative contractor is hereby advised that this constitutes technical direction as defined
in your contract. CMS does not construe this as a change to the MAC Statement of Work. The contractor is
not obligated to incur costs in excess of the amounts allotted in your contract unless and until specifically
authorized by the contracting officer. If the contractor considers anything provided, as described above, to
be outside the current scope of work, the contractor shall withhold performance on the part(s) in question
and immediately notify the contracting officer, in writing or by e-mail, and request formal directions
regarding continued performance requirements.
IV. ATTACHMENTS:
Business Requirements
Manual Instruction
*Unless otherwise specified, the effective date is the date of service.
Attachment – Business Requirements
Pub. 100-04 Transmittal: 1413 Date: January 14, 2008 Change Request: 5818
SUBJECT: Erythropoiesis Stimulating Agents (ESAs) in Cancer and Related Neoplastic
Conditions
Effective Date: NCD: July 30, 2007
Modifiers: January 1, 2008
Implementation Date: April 7, 2008
I. GENERAL INFORMATION
A. Background: The United States Food and Drug Administration (FDA) recently issued alerts and warnings
for ESAs administered for a number of clinical conditions, including cancer and renal disease. Recently
published studies report a higher risk of serious and life-threatening events associated with the use of ESAs in
various clinical applications. As a result, on March 14, 2007, CMS opened a National Coverage Analysis
(NCA) to evaluate the uses of ESAs in non-renal disease applications. On July 30, 2007, CMS issued a
Decision Memorandum for the uses of ESAs in non-renal disease applications, specifically narrowed to the use
of ESAs in cancer and other neoplastic conditions. This change request (CR) communicates the findings
resulting from the NCA and the coverage policy listed in the National Coverage Determination (NCD).
In addition, the Tax Relief and Health Care Act of 2006 requires providers to report a recent hemoglobin or
hematocrit level on claims for anti-anemia drugs administered in connection with the treatment of cancer
beginning January 1, 2008. To implement this requirement, CMS issued CR 5699, transmittal 1412, dated
January 11, 2008 that instructs providers to report a hematocrit or hemoglobin for all non-ESRD anti-anemia
claims, inclusive of ESAs. CR 5699 instructs providers to report one of three modifiers (EA, EB or EC). The
definitions of the modifiers are: EA: ESA, anemia, chemo-induced; EB: ESA, anemia, radio-induced and EC:
ESA, anemia, non-chemo/radio. Refer to CR 5699 for further reporting requirement details.
B. NCD Policy: The Centers for Medicare & Medicaid Services (CMS) reviewed the evidence and
determined that ESA treatment is reasonable and necessary under §1862(a)(1)(A) of the Social Security Act for
anemia secondary to myelosuppressive anticancer chemotherapy in solid tumors, multiple myeloma, lymphoma,
and lymphocytic leukemia under specified conditions. 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.
The complete NCD can be accessed at section 110.21 of Publication (Pub.) 100-03, NCD Manual, and claims
processing instructions can be accessed at Pub. 100-04, Claims Processing Manual, chapter 17, sections 80.8-
80.12. The HCPCS codes specific to non-ESRD ESA use are J0881 and J0885. Claims processed with dates of
service July 30, 2007, through December 31, 2007, do not have to include the ESA modifiers as they are not
effective until January 1, 2008.
II. BUSINESS REQUIREMENTS TABLE
Use“Shall" to denote a mandatory requirement
Number Requirement
Responsibility (place an “X” in each applicable
column)
Shared-System
Maintainers
A
/
B
M
A
C
D
M
E
M
A
C
F
I
C
A
R
R
I
E
R
R
H
H
I
F
I
S
S
M
C
S
V
M
S
C
W
F
OTHER
Number Requirement
Responsibility (place an “X” in each applicable
column)
Shared-System
Maintainers
A
/
B
M
A
C
D
M
E
M
A
C
F
I
C
A
R
R
I
E
R
R
H
H
I
F
I
S
S
M
C
S
V
M
S
C
W
F
OTHER
5818.1 Effective for claims with dates of service on and after
January 1, 2008, standard systems maintainers
(SSMs) shall deny non-ESRD ESA services for
HCPCS J0881 or J0885 billed with modifier EC
(ESA, anemia, non-chemo/radio) when any one of
the following diagnosis codes is present on the claim:
-any anemia in cancer or cancer treatment patients
due to folate deficiency (281.2),
B-12 deficiency (281.1, 281.3),
iron deficiency (280.0-280.9),
hemolysis (282.0, 282.2, 282.9, 283.0, 283.2, 283.9-
283.10, 283.19), or
bleeding (280.0, 285.1),
-anemia associated with the treatment of acute and
chronic myelogenous leukemias (CML, AML)
(205.00-205.21, 205.80-205.91), or,
erythroid cancers (207.00-207.81).
X X
5818.1.1 Effective for claims with dates of service on and after
January 1, 2008, contractors shall deny non-ESRD
ESA services for HCPCS J0881 or J0885 billed with
modifier EC (ESA, anemia, non-chemo/radio) for:
-any anemia in cancer or cancer treatment patients
due to bone marrow fibrosis,
-anemia of cancer not related to cancer treatment,
-prophylactic use to prevent chemotherapy-induced
anemia,
-prophylactic use to reduce tumor hypoxia,
-patients with erythropoietin-type resistance due to
neutralizing antibodies, and
-anemia due to cancer treatment if patients have
uncontrolled hypertension.
X XX X
5818.2 Effective for claims with dates of service on and after X X
Number Requirement
Responsibility (place an “X” in each applicable
column)
Shared-System
Maintainers
A
/
B
M
A
C
D
M
E
M
A
C
F
I
C
A
R
R
I
E
R
R
H
H
I
F
I
S
S
M
C
S
V
M
S
C
W
F
OTHER
January 1, 2008, SSMs shall deny non-ESRD ESA
services for HCPCS J0881 or J0885 billed with
modifier EB (ESA, anemia, radio-induced).
5818.3 Effective for claims with dates of service on and after
January 1, 2008, contractors shall deny non-ESRD
ESA services for HCPCS J0881 or J0885 billed with
modifier EA (ESA, anemia, chemo-induced) for
anemia secondary to myelosuppressive anticancer
chemotherapy in solid tumors, multiple myeloma,
lymphoma, and lymphocytic leukemia when a
hemoglobin 10.0g/dL or greater or hematocrit 30.0%
or greater is reported.
NOTE: ESA treatment duration for each course of
chemotherapy includes the 8 weeks following the
final dose of myelosuppressive chemotherapy in a
chemotherapy regime.
X XX X
5818.4 Effective for claims with dates of service on and after
January 1, 2008, Medicare contractors shall have
discretion to establish local coverage policies for
those indications not included in NCD 110.21
X XX X
5818.5 Contractors shall deny non-ESRD ESA services for
cancer and related neoplastic indications included in
NCD 110.21 based on reasonable and necessary
determinations. A provider may have the beneficiary
sign an Advance Beneficiary Notice, making the
beneficiary liable for services not covered by
Medicare.
X XX X
5818.5.1 Denials are subject to appeal and SSMs shall allow
for medical review override of denials for appeal
purposes.
X X
5818.5.2 SSMs shall assign liability for the denied charges to
the provider unless documentation of the ABN is
present on the claim.
X X
5818.5.3 Contractors shall use MSN message 15.20, The
following policies [NCD 110.21] were used when we
made this decision, and remittance reason code 50,
These are non-covered services because this is not
deemed a `medical necessity' by the payer, for
medical necessity denials of non-ESRD ESA claims
for cancer and related neoplastic indications included
in NCD 110.21.
X X X X X
5818.6 Claims processed prior to April 7, 2008, shall not be
searched for adjustment. However, contractors shall
adjust claims if brought to their attention.
X XX X
III. PROVIDER EDUCATION TABLE
Number Requirement
Responsibility (place an “X” in each applicable
column)
Shared-System
Maintainers
A
/
B
M
A
C
D
M
E
M
A
C
F
I
C
A
R
R
I
E
R
R
H
H
I
F
I
S
S
M
C
S
V
M
S
C
W
F
OTHER
5818.7 A provider education article related to this instruction
will be available at
http://www.cms.hhs.gov/MLNMattersArticles shortly
after the CR is released. You will receive notification of
the article release via the established "MLN Matters"
listserv.
Contractors shall post this article, or a direct link to this
article, on their Web site and include information about it
in a listserv message within one week of the availability
of the provider education article. In addition, the
provider education article shall be included in your next
regularly scheduled bulletin. Contractors are free to
supplement MLN Matters articles with localized
information that would benefit their provider community
in billing and administering the Medicare program
correctly.
X XX X
IV. SUPPORTING INFORMATION
A. For any recommendations and supporting information associated with listed requirements, use the
box below:
Use "Should" to denote a recommendation.
X-Ref
Requireme
nt
Number
Recommendations or other supporting information:
B. For all other recommendations and supporting information, use this space:
V. CONTACTS
Pre-Implementation Contact(s):
National Coverage Determination: Maria Ciccanti, m[email protected], 410-786-3107,
Pat Brocato-Simons, [email protected], 410-786-0261,
Kim Long, [email protected], 410-786-5702
Institutional Claims Processing: Sherry Murray,
[email protected], 410-786-6145
Practitioner Claims Processing: Melvia Page-Lasowski,
[email protected], 410-786-4727
Post-Implementation Contact(s): Appropriate RO
VI. FUNDING
A. For Fiscal Intermediaries, Carriers, and the Durable Medical Equipment Regional Carrier (DMERC):
No additional funding will be provided by CMS; contractor activities are to be carried out within their
operating budgets.
B. For Medicare Administrative Contractors (MACs):
The contractor is hereby advised that this constitutes technical direction as defined in your contract. CMS does
not construe this as a change to the Statement of Work (SOW). The contractor is not obligated to incur costs in
excess of the amounts allotted in your contract unless and until specifically authorized by the contracting
officer. If the contractor considers anything provided, as described above, to be outside the current scope of
work, the contractor shall withhold performance on the part(s) in question and immediately notify the
contracting officer, in writing or by e-mail, and request formal directions regarding continued performance
requirements.
Medicare Claims Processing Manual
Chapter 17 - Drugs and Biologicals
Table of Contents
(Rev. 1413, 01-14-08)
80.12 – Claims Processing Rules for ESAs Administered to Cancer Patients
for Anti-Anemia Therapy
80.12 – Claims Processing Rules for ESAs Administered to Cancer
Patients for Anti-Anemia Therapy
(Rev. 1413; Issued: 01-14-08; Effective: 07-30-07; Implementation: 04-07-08)
The national coverage determination (NCD) titled, “The Use of ESAs in Cancer and
Other Neoplastic Conditions” lists coverage criteria for the use of ESAs in patients who
have cancer and experience anemia as a result of chemotherapy or as a result of the
cancer itself. The full NCD can be viewed in Publication 100-03 of the NCD Manual,
section 110.21.
Effective for claims with dates of service on and after January 1, 2008, non-ESRD ESA
services for HCPCS J0881 or J0885 billed with modifier EC (ESA, anemia, non-
chemo/radio) shall be denied when any one of the following diagnosis codes is present on
the claim:
o any anemia in cancer or cancer treatment patients due to folate deficiency (281.2),
o B-12 deficiency (281.1, 281.3),
o iron deficiency (280.0-280.9),
o hemolysis (282.0, 282.2, 282.9, 283.0, 283.2, 283.9-283.10, 283.19), or
o bleeding (280.0, 285.1),
o anemia associated with the treatment of acute and chronic myelogenous leukemias
(CML, AML) (205.00-205.21, 205.80-205.91); or
o erythroid cancers (207.00-207.81).
Effective for claims with dates of service on and after January 1, 2008, contractors shall
deny non-ESRD ESA services for HCPCS J0881 or J0885 billed with modifier EC (ESA,
anemia, non-chemo/radio) for:
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; and
o anemia due to cancer treatment if patients have uncontrolled hypertension.
Effective for claims with dates of service on and after January 1, 2008, non-ESRD ESA
services for HCPCS J0881 or J0885 billed with modifier EB (ESA, anemia, radio-
induced), shall be denied.
Effective for claims with dates of service on and after January 1, 2008, contractors shall
deny non-ESRD ESA services for HCPCS J0881 or J0885 billed with modifier EA (ESA,
anemia, chemo-induced) for anemia secondary to myelosuppressive anticancer
chemotherapy in solid tumors, multiple myeloma, lymphoma, and lymphocytic leukemia
when a hemoglobin 10.0g/dL or greater or hematocrit 30.0% or greater is reported.
NOTE: ESA treatment duration for each course of chemotherapy includes the 8 weeks
following the final dose of myelosuppressive chemotherapy in a chemotherapy regime.
Effective for claims with dates of service on and after January 1, 2008, Medicare
contractors shall have discretion to establish local coverage policies for those
indications not included in NCD 110.21
Denials of claims for ESAs are based on reasonable and necessary determinations
established by NCD 110.21. A provider may have the beneficiary sign an Advanced
Beneficiary Notice, making the beneficiary liable for services not deemed reasonable and
necessary and thus not covered by Medicare.
Report Medicare Summary Notice message 15.20, “The following policies [NCD 110.21]
were used when we made this decision”, and remittance reason code 50, “These are non-
covered services because this is not deemed a `medical necessity' by the payer” for
denied ESA claims.
Medicare contractors have the discretion to conduct medical review of claims and
reverse the automated adjudication if the medical review results in a determination of
clinical necessity.
