CMS Pub. 100-04, ch. 8, § 60.4.1

Effective for services provided on or after April 1, 2006, Medicare has implemented a

national claims monitoring policy for ESAs administered in Medicare renal dialysis

facilities. This policy does not apply to claims for ESAs for patients who receive their

dialysis at home and self-administer their ESA.

While Medicare is not changing its coverage policy on erythropoietin use to maintain a

target hematocrit level between 30% and 36%, we believe the variability in response to

ESAs warrants postponing requiring monitoring until the hematocrit reaches higher

levels. For dates of services April 1, 2006, and later, the Centers for Medicare &

Medicaid Services (CMS) claims monitoring policy applies when the hematocrit level

exceeds 39.0% or the hemoglobin level exceeds 13.0g/dL. This does not preclude the

contractors from performing medical review at lower levels.

Effective for services provided on or after April 1, 2006, for claims reporting hematocrit

or hemoglobin levels exceeding the monitoring threshold, the dose shall be reduced by

25% over the preceding month. Providers may report that a dose reduction did occur in

response to the reported elevated hematocrit or hemoglobin level by adding a GS

modifier on the claim. The definition of the GS modifier is defined as: “Dosage of ESA

has been reduced and maintained in response to hematocrit or hemoglobin level.” Thus,

for claims reporting a hematocrit level or hemoglobin level exceeding the monitoring

threshold without the GS modifier, CMS will reduce the covered dosage reported on the

claim by 25%. The excess dosage is considered to be not reasonable and necessary.

Providers are reminded that the patient’s medical records should reflect

hematocrit/hemoglobin levels and any dosage reduction reported on the claim during the

same time period for which the claim is submitted.

Effective for dates of service provided on and after January 1, 2008, requests for

payments or claims for ESAs for ESRD patients receiving dialysis in renal dialysis

facilities reporting a hematocrit level exceeding 39.0% (or hemoglobin exceeding

13.0g/dL) shall also include modifier ED or EE. Claims reporting neither modifier or

both modifiers will be returned to the provider for correction.

The definition of modifier ED is “The hematocrit level has exceeded 39.0% (or

hemoglobin 1evel has exceeded 13.0g/dL) 3 or more consecutive billing cycles

immediately prior to and including the current billing cycle.” The definition of modifier

EE is “The hematocrit level has exceeded 39.0% (or hemoglobin level has exceeded

13.0g/dL) less than 3 consecutive billing cycles immediately prior to and including the

current billing cycle.” The GS modifier continues to be defined as stated above.

Providers may continue to report the GS modifier when the reported hematocrit or

hemoglobin levels exceed the monitoring threshold for less than 3 months and a dose

reduction has occurred. When both modifiers GS and EE are included, no reduction in

the covered dose will occur. Claims reporting a hematocrit or hemoglobin level

exceeding the monitoring threshold and the ED modifier shall have an automatic 50%

reduction in the covered dose applied, even if the claim also reports the GS modifier.

Below is a chart illustrating the resultant claim actions under all possible reporting

scenarios:

Hct Exceeds

39.0% or

Hgb Exceeds

13.0g/dL

ED

Modifier?

(Hct >39%

or Hgb

>13g/dL ≥3

cycles)

EE Modifier?

(Hct >39% or

Hgb >13g/dL

<3 cycles)

GS

Modifier?

(Dosage

reduced and

maintained)

Claim Action

No N/A N/A N/A Do not reduce

reported dose.

Yes No No No

Return to provider

for correction. Claim

must report either

modifier ED or EE.

Yes No No Yes

Return to provider

for correction. Claim

must report either

modifier ED or EE.

Yes No Yes Yes Do not reduce

reported dose.

Hct Exceeds

39.0% or

Hgb Exceeds

13.0g/dL

ED

Modifier?

(Hct >39%

or Hgb

>13g/dL ≥3

cycles)

EE Modifier?

(Hct >39% or

Hgb >13g/dL

<3 cycles)

GS

Modifier?

(Dosage

reduced and

maintained)

Claim Action

Yes No Yes No Reduce reported

dose 25%.

Yes Yes No Yes Reduce reported

dose 50%.

Yes Yes No No Reduce reported

dose 50%.

In some cases, physicians may believe there is medical justification to maintain a

hematocrit above 39.0% or hemoglobin above 13.0g/dL. Beneficiaries, physicians,

and/or renal facilities may submit additional medical documentation to justify this belief

under the routine appeal process. You may reinstate any covered dosage reduction

amounts under this first level appeal process when you believe the documentation

supports a higher hematocrit/hemoglobin level.

Providers are reminded that, in accordance with FDA labeling, CMS expects that as the

hematocrit approaches 36.0% (hemoglobin 12.0g/dL), a dosage reduction occurs.

Providers are expected to maintain hematocrit levels between 30.0 to 36.0% (hemoglobin

10.0-12.0g/dL). Hematocrit levels that remain below 30.0% (hemoglobin levels below

10.0g/dL)) despite dosage increases, should have causative factors evaluated. The

patient’s medical record should reflect the clinical reason for dose changes and

hematocrit levels outside the range of 30.0-36.0% (hemoglobin levels 10.0-12.0g/dL).

Medicare contractors may review medical records to assure appropriate dose reductions

are applied and maintained and hematological target ranges are maintained.

These hematocrit requirements apply only to ESAs furnished as an ESRD benefit under

§1881(b) of the Social Security Act.

Effective January 1, 2020, the EMP is discontinued under the ESRD PPS. Prescribing

practitioners should continue to prescribe ESAs in accordance with ESA dosing

guidelines and ESRD facilities should continue to report what they furnish.

The type of bill 72X will no longer be subject to dose reductions or ESA dose limitations.

ESRD facilities are not required to report the following modifiers:

1. GS - Dosage of erythropoietin stimulating agent has been reduced and maintained in

response to hematocrit or hemoglobin level

2. ED - Hematocrit level has exceeded 39% (or hemoglobin level has exceeded 13.0 g/dl)

for 3 or more consecutive billing cycles immediately prior to and including the current

cycle

3. EE - Hematocrit level has not exceeded 39% (or hemoglobin level has not exceeded

13.0 g/dl) for 3 or more consecutive billing cycles immediately prior to and including the

current cycle

Medically Unlikely Edits (MUE)

For dates of service on and after January 1, 2008, the MUE for claims billing for

Epogen® is reduced to 400,000 units from 500,000. The MUE for claims for Aranesp®

is reduced to 1200 mcg from 1500 mcg.

It is likely that claims reporting doses exceeding the threshold reflect typographical errors

and will be returned to providers for correction.

Effective January 1, 2020 the medically unlikely edits for ESAs exceeding the threshold

limits above are discontinued under the ESRD PPS.