ESAs
A Comprehensive Review
Agenda






The NCD in Review
NCD Implementation in Review
Billing Medicare for anemia/ ESAs
The Labeling Change
What about non-Medicare payers?
FAQs
Disclaimer
 This presentation is valid for the day of
presentation only.
 This presentation references Medicare policy only.
Other payers may have other guidelines. It is the
responsibility of the providers to ascertain this
information.
 This presentation is not clinical, coding or legal
advice.
 This presentation references products only insofar
as they pertain to national policy and is not
approved by any manufacturer.
These are your primary NCD
information sources…
 View the policy itself at
 http://www.cms.hhs.gov/mcd/viewdecisionmemo.asp?id
=203
 View CMS FAQs
 http://www.cms.hhs.gov/mcd/ncpc_view_document.asp
?id=12
 View ASCO FAQs
 http://www.ascofoundation.org/portal/site/ASCO/menuit
em.5d1b4bae73a9104ce277e89a320041a0/?vgnextoid
=24be6e7507523110VgnVCM100000ed730ad1RCRD
MEDICARE NATIONAL COVERAGE PROCESS
Preliminary
Discussions
Benefit
Category
National
Coverage
Request
Reconsideration
6 months
Staff
Review
30 days
Draft
Decision
Memorandum
Posted
External
Technology
Assessment
Medicare
Coverage
Advisory
Committee
9 months
Staff
Review
60 days
Public
Comments
Final Decision
Memorandum
and
Implementation
Instructions
Department
Appeals
Board
The Actual NCD
 Is a national coverage decision
 Overrides LCDs for diagnoses included in the decision.
Diagnosis coding guidelines are still local.
 Cannot be reviewed by your CAC, MAC, FI, or Carrier
Medical Director
 Applicable to Quality Improvement Organizations,
qualified independent contractors (RACs??), Medicare
Appeals Councils and Administrative Law Judges.
 Not applicable to Medicare Advantage, unless it
expands coverage.
 Part D plans have been warned about the the NCD, but
it is not binding.
The Actual Effective Dates
 July 30 2007
 This is the date for which you are responsible for this policy.
 September 30 2007
 The CMS contractors have until this time to put the policies in
their system.
 This may lead to different billing and coding guidelines for
some Carriers, but H/H not necessary for all Part B Carriers
until 1/1/2008 as part of PQRI.
 January 1, 2008 is the date that you must “follow” the billing
parameters.
 April 7, 2008 is the date that all billing parameters had to be
followed by Carriers.
 August 14, 2008 was the date for the new label to be final.
The Medicare
 ESAs are NOT reasonable and necessary in these
conditions, according to CMS








Any anemia in cancer or cancer treatment of patients due to folate
deficiency, B-12 deficiency, iron deficiency, hemolysis, bleeding, or
bone marrow fibrosis;
The anemia associated with AML or CML or erythroid cancers;
The anemia of cancer not associated with treatment;
Any anemia associated only with Radiation Therapy;
Prophylactic use to prevent chemo-induced anemia;
Prophylactic use to reduce tumor hypoxia;
Patients with erythropoetin-type resistance due to neutralizing
antibodies; and,
Anemia due to cancer treatment IF the patient has uncontrolled
hypertension.
What this means…
 Medicare will deny these codes:
 Any anemia or cancer treatment related 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)
 Bleeding (280.0, 280.1)
 Anemia associated with the treatment of acute and chronic
myelogenous leukemias (205.00-205.21, 205.80-205.91)
 Erythroid cancers (207.00-207.81)
Source--Transmittal 1413, CR 5818, 1/14/08
What this means
 Effective for dates of service on or after January
1, 2008, contractors shall deny all claims for
HCPCS J0881 or J0885 billed with Modifier -EC
for:





The anemia of cancer not associated with treatment;
Prophylactic use to prevent chemo-induced anemia;
Prophylactic use to reduce tumor hypoxia;
Patients with erythropoetin-type resistance due to neutralizing
antibodies; and,
Anemia due to cancer treatment IF the patient has uncontrolled
hypertension.
Source--Transmittal 1413, CR 5818, 1/14/08
What this means
 Effective for dates of service on and after
January 1, 2008, contractors shall deny all
claims for HCPCS J0881 or J0885 billed
with Modifier -EB for:
 Anemia, radiotherapy-induced
Source--Transmittal 1413, CR 5818, 1/14/08
The Actual Decision
 “We have also determined that ESA
treatment for the anemia secondary to
myelosuppressive anti-cancer
chemotherapy in solid tumors, multiple
myeloma, lymphoma, and lymphocytic
leukemia is only reasonable and
necessary under the following specified
conditions…”
The Actual Decision
 Specified Conditions:
1. The hemoglobin level immediately prior to
initiation OR maintenance of ESA treatment is
< 10 g/dL or hematocrit < 30%,
2. The starting dose for ESA treatment is the
recommended FDA starting dose, no more
than 150U/kg (EPO) three times weekly or
40,000 units weekly and 2.25 mcg/kg/weekly
for darbepoetin or 500 mcg every 3 weeks.
The Actual Decision
 Specified Conditions:
3.
4.
Maintenance of ESA therapy is the starting dose, if the
hemoglobin remains below 10g/dL (or hematocrit <
30%) 4 weeks after initiation of therapy AND the rise in
Hgb >/= 1g/dL (hematocrit >/= 3%).
If a patient’s hemoglobin rises <1g/dL compared to a
pre-treatment baseline over 4 weeks of treatment and
whose hemoglobin remains below 10g/dL (or Hct=
30%), the FDA starting dose may be increased once
by 25%. Continued use of the drug may not be
reasonable and necessary if the hemoglobin rises < 1
g/dL (Hct < 3%) compared to the pre-treatment
baseline after 8 weeks of therapy.
The Actual Decision
 Specified Conditions
5.
6.
Continued administration of the drug is not reasonable
and necessary if there is a rapid rise in hemoglobin > 1
gm/dL (Hct > 3%) over 2 weeks of treatment, UNLESS
the hemoglobin remains below or substantially falls to
< 10 gm/dL (hct < 30%). Continuation and reinstitution
of ESA therapy must include a dose reduction of 25%
from previously administered dose, the H/H guidelines
are met.
ESA treatment for each course of chemotherapy
includes 8 weeks following the final dose of
myelosuppressive chemotherapy in a given
chemotherapy regimen.
What it means
 Effective for claims with dates of service on and
after January 1, 2008, contractors shall deny nonESRD ESA services for HCPCS J0881 or J0885
with Modifier -EA for anemia secondary to
myelosuppressive chemotherapy in solid tumors,
multiple myeloma, lymphoma, and lymphocytic
leukemia when…
 Hgb is 10.0g/dl or the Hct is 30% or greater and is
reported. There is no four week moratorium in wiring;
there is a hard edit.
 This contradicts the original policy.
Source--Transmittal 1413, CR 5818, 1/14/08
What it means
 “Medicare contractors have the discretion
to conduct medical review of claims and
reverse the automated adjudication if the
medical review results in clinical
necessity…”
Source--Transmittal 1413, CR 5818, 1/14/08
Billing
 Per Transmittal 1412, CR 5699:





Claims for non-ESRD ESAs (J0881 and J0885) starting January 1, 2008 must include one
of three modifiers: -EA (ESA, anemia, chemo-induced); -EB (ESA, anemia, radiotherapyinduced); and, -EC (ESA, anemia, non-chemotherapy or radiotherapy induced).
Claims for any treatment of anemia associated with cancer treatment using drugs that are
not self-administered must include the "most recent" hemoglobin or hematocrit level using
a three digit format xx.x.
Claims for ESAs (J0881, J0882, J0885, J0886, and Q4081) must include the "most recent"
hemoglobin or hematocrit level using a three digit format xx.x.
The level must be reported using xx.x format in Box 19 or, for electronic claims, providers
must report levels in Loop 2400 MEA segment. Specifics of this reporting are MEA01 =
TR (for test results); MEA02 = R1 (for hemoglobin) or R2 (for hematocrit); and, MEA03 =
test results. The test results shall be entered as follows: TR= test results (backslash),
R1=hemoglobin, or R2=hematocrit (backslash), and the most current numeric test result
figure up to 3 numerics and a decimal point [xx.x]). Example for hemoglobin tests:
TR/R1/9.0 (or 09.0--not clear in the transmittal), Example for hematocrit tests:
TR/R2/27.0.
"Contractors shall not retroactively search for claims with dates of service January
1, through the implementation date [April 7, 2008], but may adjust claims if brought
to their attention". Watch your MAC or Carrier web site for more details..
Billing
 All claims from 1/1/2008 that do not meet these specifications will
be sent back as unprocessable. Reason Code 4 and Remark
code MA 130 to return ESA services without the required
modifier. Claims without the most recent hematocrit or
hemoglobin will be sent back with Reason Code 16 and MA130
and N395. The same Reason Code will be used for other anemia
drugs.

HOWEVER, the transmittal in Section 5699.12 says that "Contractors
shall not retroactively search for claims with dates of service
January 1, through the implementation date [April 7, 2008], but may
adjust claims if brought to their attention". Watch your MAC or
Carrier web site for more details..
ESA/Anemia Billing Summary
 If the patient has cancer and is on chemotherapy, submit the
“most recent” hemoglobin must be <10 (or Hct < 30%). Bill the H
or H results and use -EA. Follow Carrier guidelines for diagnosis
coding.
 If the patient is on Radiotherapy, submit the latest H or H result,
use -EB, and get denied.
 If the patient does not have chemotherapy-induced anemia (or
ESRD), submit the latest H or H, use -EC, and follow your
Carrier’s guidelines for coding and billing.
 If the patient has cancer and is on an anemia drug which is not
self-administered, submit the latest H or H result. All other
guidelines are at Carrier discretion.
The Label Change
 FDA, when unable to compromise on label
changes to the cancer indications for ESAs,
invoked its authority under 505(o)(4) of the Federal
Food, Drug, and Cosmetic Act (“FDCA”) to require
safety related label changes to ESAs to address
the risk of increased mortality and/or tumor
outcomes when patients are receiving cancer
treatment and in cancer patients with anemia who
are receiving no treatment.
The Label Change
 Label Changes
 “When the anticipated outcome of myelosuppressive
chemotherapy is cure, Aranesp®/PROCRIT® is not
indicated.” This does not say CONTRAINDICATED.
 Therapy should not be initiated at hemoglobin levels ≥ 10
g/dL.
 Upper level of “exceeds 12g/dL” is deleted. May only
dose until transfusion can be avoided. Level is different
in every patient.
Other FDA Guidelines
 There must be a REMS (Risk Evaluation and Mitigation)
Strategy for ESAs. This can include
 A Medication Guide outlining the risks and benefits of use for
all indications of ESAs. This should be distributed now.
 An easy to read and understand patient package insert with
patient instructions for use,
 A communication plan evidencing that the elements to assure
safe use have been relayed effectively to the patient,
 And an implementation or verification system assuring provider
compliance, along with a timetable for assessment of the
REMS.
 This is currently not final and will not be totally final until the end of
the year.
What It Means
 “Anticipated outcome is cure”
 Studies have not been done on patients in the absence
of metastatic disease. No data to support outcomes of
patients where a cure is anticipated.
Neo-adjuvant and adjuvant setting with tumor
eradication, no metastases.
No metastases?
Cure versus prolonged survival/tumor shrinkage?.
Is the treatment palliative?
Must be a decision made in your practice…as in right
now.
What It Means
 Treatment should not be initiated at
hemoglobin levels ≥ 10 g/dL.
 Self-explanatory
 All patients treated like Medicare in the
chemotherapeutic setting.
What It Means
 Upper level of 12 g/dL is deleted to read “Withhold
dose if: hemoglobin exceeds a level needed to
avoid transfusion”.
 No clinical benefit 10-12g/dL proven in clinical studies,
according to FDA.
 Better mortality at lower levels with lower trigger.
 Basically, benefit versus risk analysis indicates that
nothing past requirement for transfusion is beneficial.
What It Means
 REMS Strategy
 Similar to programs for Thalomid®, Revlimid®, Tysabri®--but voluntary.
 Physicians must register to demonstrate compliance with
patient consent and information dissemination.
 Patient consent with risks and benefits of therapy.
 A card proving that the patient has received information
must be filed on each patient
 Patient medication guide now available at
http://www.fda.gov/cder/drug/infopage/RHE/default.h
tm. This guide is for all ESA patients---not just those with
cancer.
What Payers Will Do…Maybe
Status of the world right now
 Medicare has an NCD, which has caused no
end of confusion and high denial rates.
 Medicare has not responded in any official way
to the label change. They say “no code for
‘curative intent’”.
 Private payers are subject to payer policies and
state laws. Many state insurance policies
reference FDA labeling.
Medicare Label Rules
 “Drugs or biologicals approved for marketing by
the Food and Drug Administration (FDA) are
considered safe and effective for purposes of this
requirement when used for indications specified on
the labeling.”
 Drugs are only considered ‘reasonable and
necessary’ when safe and effective under the
statute.
Medicare Benefit Policy Manual, Chapter 15, Section
50.4.1
Medicare Policy
 “If a medication is determined not to be reasonable and
necessary for diagnosis or treatment of an illness or injury
according to these guidelines, the carrier excludes the entire
charge (i.e., for both the drug and its administration). Also,
carriers exclude from payment any charges for other services
(such as office visits) which were primarily for the purpose of
administering a noncovered injection (i.e., an injection that is
not reasonable and necessary for the diagnosis or treatment of
an illness or injury).”
 Medicare Benefit Policy Manual, Chapter 15, Section
50.4.3
Medicare Rules
Will Medicare publish a new NCD?
 “60-90 day” window
 Current NCD hemoglobin levels are in line with
the new label.
 AGAIN, “no code for ‘curative’ or anticipated
cure”.
 REMS or any compliance program not really
part of the billing process.
But, you still need to be in compliance with
current rules.
Non-Medicare
Differences Medicare versus Non-Medicare
 Prior Authorization can determine compliance
with labeling.
 Contract language and/or payer policy may
cover drug labeling or FDA requirements.
 State insurance laws generally do specify
relationship of FDA labeling and coverage. This
is applicable to non-ERISA plans.
Questions & Answers
 Is there a requirement to test the hemoglobin at 5th week of ESA
administration?
 CMS Response: CMS did not mandate how frequently a
physician monitors their patient’s hemoglobin (hematocrit) level.
However, continued coverage of ESA therapy is dependent of the
beneficiary continuing to meet the coverage requirements. But,
this must be the ‘latest’ test result.
Questions & Answers


What if, in week five, the patient’s hemoglobin is 11g/dl (whether the
doctor knows it or not), does/should ESA coverage continue?
CMS Response: CMS does not provide coverage, that is, will not pay a
claim, for the administration of ESAs unless the hemoglobin level
immediately prior to initiation or maintenance of ESA treatment is < 10
g/dL (or the hematocrit is < 30%). Thus we would not expect to pay ESA
claims that are not accompanied by a timely hemoglobin or hematocrit
Questions & Answers
 What does “equivalent doses may be given over other
approved time periods” mean?
 ASCO Clarification: All FDA-approved dosing regimens are
covered under the NCD. Therefore, for EPO, will cover the
labeled once per week dosing and, for darbepoetin, they
will cover the alternative flat dose every three weeks that is
listed in the label.
Questions & Answers
 Do I need to report any modifiers on these claims?
 ASH Response: Yes. Effective January 1, 2008, all nonESRD claims for administrations of ESAs reporting either
the most recent hematocrit or hemoglobin level, must
contain one of the following three modifiers:
 EA: ESA, anemia, chemo-induced
 EB: ESA, anemia, radio-induced
 EC: ESA, anemia, non-chemo/radio
 Professional claims that are billed without the required
modifiers will be returned.
Questions & Answers

Do I need to draw the hemoglobin or hematocrit level each time an ESA
is administered?

ASH Response: No you do not. CMS has clarified in the 2008 Final
Physician Rule that this mandate does not mean that the hemoglobin or
hematocrit level should be drawn each time an ESA is administered. The
requirement is that "the most recent" hemoglobin or hematocrit level be
reported on the claim. Thus, the provider should report the most recent
level preceding the ESA administration. CMS recognizes that in some
instances the same hemoglobin or hematocrit value might be reported
on more than one claim.
Questions & Answers
 Wouldn't the imposition of a ceiling of hemoglobin 10 g/dL
(hematocrit 30%) override the physician discretion on an FDA
label to use the lowest dose sufficient to avoid transfusions, not
to exceed 12g/dl?
 CMS Response: We are unaware of robust clinical evidence that
transfusion is indicated for patients whose hemoglobin is less
than 10g/dL. In fact, evidence based reviews of transfusion
thresholds generally note 7 or 8 g/dL as the clinically appropriate
transfusion threshold. NCDs instruct Medicare contractors on the
payment of claims; they do not prohibit a physician from
administering any treatment that he or she believes is indicated.
Questions & Answers
 Is there some warning about head and
neck cancer and breast cancer?
 No, these were proposed in the original
labeling draft from ODAC, but were not
included in the final labeling.
Questions & Answers
 Do you think all payers will use CMS
guidelines for the upper limit of dosing?
 Since the upper limit is not defined, they may
not define it, since it is not specific in the label..
 CMS has not changed their NCD.
Questions & Answers
When should we start treating patients
according to label?
 Always up to the doctor, but the label was final
officially August 14, 2008.
 Labeling changes ONLY apply to CIA patients.
 Labeling DOES NOT apply to HIV/AIDS, CRF,
MDS, chronic disease, etc.
Questions & Answers
 Does the NCD parameter of dosing only up
to 10 g/dL apply to all indications?
 No, this only applies to the chemotherapyinduced anemia, myelosuppressive setting.
 This only applies to Medicare patients, at the
current time. Other payers may elect to use it-but this is CMS policy.
Drug Hotlines
 AMGEN Reimbursement Connection® (800--2729376)








Speak to a reimbursement expert who specializes in the insurance policies of your region.
Payor policy research and information--Have our reimbursement experts research payor coverage,
coding, and reimbursement policies.
Insurance verification assistance--Let us assist you in verifying your patients' benefits and identifying
insurer coverage guidelines.
Prior authorization assistance--Allow us to research your patients' prior authorization requirements,
help you obtain prior authorization, and remind you when the next prior authorizations are needed.
Claim review and reconciliation--Helps you track the progress of your claims and, when needed, work
with the insurer to identify the reason(s) for denied or underpaid claims and necessary actions to
resolve the problem.
Coordination of benefits--Coordinate primary and secondary coverage for collection of co-payments or
co-insurance.
Alternative sources of payment--Ask us to help identify alternative coverage sources for Amgen
products -- Non-Profit Co-Payment Assistance Programs
Support Programs--Let us provide information on the SAFETY NET® Foundation for medically
indigent patients.
Drug Hotlines
 PROCRITline® (800-553-3851)
 Staffed by insurance specialists who provide
reimbursement counsel, assistance in claims
submissions and appeals, free carrier intervention
services, "letters of medical necessity," etc., regarding
all qualified nondialysis patients undergoing therapy
with the anti-anemia product PROCRIT®.
 PROCRITline® also provides information about
qualifying for and enrolling in the following financial
support programs offered by Ortho Biotech.
Strategies for Practices




Determine what ‘curative intent’ means in your practice.
Based on the NCD, you should assess the impact of the usage changes on your
 Drug costs
 Drug reimbursement
 Drug rebates
Once you have done this
 Check the change in profitability.
 Check the change in operating cash.
Participate in the struggle!
 Get involved in the ‘prompt pay’
 Other actions