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/menuitem.5d1b4bae73a9104ce277e89a320041a0/?vgnextoid=24be6e7507523110VgnVCM100000ed730ad1RCRD

MEDICAREMEDICARE NATIONALNATIONAL COVERAGECOVERAGE PROCESSPROCESS

Staff Review

Draft Decision

Memorandum Posted

Nationa

l Coverag

e Request

Medicare Coverage Advisory Committee

External Technolog

y Assessmen

t

6 months

Reconsideration

Staff Review

Public Comments

Final Decision

Memorandumand

Implementation

Instructions

30 days

60 days

9 months

Preliminary

Discussions

Benefit Categor

y

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. 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%).

4. 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. 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.

6. 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 non-ESRD 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, radiotherapy-induced); 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.htm. 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 non-

ESRD 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 chemotherapy-

induced 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--272-

9376) 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