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Monitoring of Erythropoietin Stimulating Agents for Beneficiaries with End Stage Renal Disease

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Date:

07/20/2007

Public Comment Period:

07/20/2007 - 08/19/2007    View Public Comments

Monitoring of Erythropoietin Stimulating Agents for Beneficiaries with End Stage Renal Disease
January 2008

Background
Erythropoietin stimulating agents (ESA) are drugs used for anemia management for patients with renal disease. They are indicated in end stage renal disease (ESRD) patients and approved by the FDA to maintain hematocrit levels within a target range of 30-36 percent.

The original methodology for monitoring ESA claims was implemented with limited scientific analysis. It limits monitoring of ESAs to post-payment review based on a 90-day rolling average of claims. The target average hematocrit to trigger action was 37.5 percent, to provide recognition of naturally occurring variability in hematocrit levels. Additionally, higher levels could be maintained upon medical justification by the treating physician. This methodology and its revisions were issued through a series of temporary instructions.

In the fall of 2003, CMS solicited scientific information from the ESRD community in order to develop a permanent evidence-based policy for ESA monitoring. The scientific literature demonstrated that patients with hematocrit levels within the target range had better health outcomes than those with hematocrits below the target level. The data also demonstrated that there is considerable natural variability in individual patient hematocrit levels, making it difficult to consistently maintain a hematocrit within the narrow range of 33-36 percent.

In July 2004, CMS posted a proposed policy for monitoring of ESAs in patients with ESRD. CMS accepted formal public comment on the proposed policy until October 7, 2004. Additional public comments were presented and considered, including a consensus recommendation by the Kidney Care Partners. After considering all of the comments submitted, CMS issued a final policy, announced in CR 4135, that effective April 1, 2006 Medicare contractors will initiate monitoring of ESRD ESA claims when the hematocrit level reaches 39.0 (or hemoglobin of 13.0). For claims with hematocrit readings above the threshold of 39.0 (or hemoglobin above 13.0), the dose should be reduced by 25 percent over the preceding month. If the dose has been reduced by 25 percent, dialysis facilities report modifier GS on the claim. Modifier GS was defined as “Dosage of EPO or Darbepoietin Alfa has been reduced 25% of preceding month’s dosage.”

When the GS modifier appears on the claim, Medicare contractors make payment based on the reported dosage. For claims with hematocrit levels above 39.0 (hemoglobin above 13.0) without modifier GS, Medicare contractors reduce the dosage payable by 25 percent of that reported on the claim.

Medicare contractors do make payment for dosage of EPO in excess of 500,000 IUs per month or dosage of Aranesp greater than 1500 mcg per month. If dosage exceeds these thresholds, Medicare contractors return the claim to the provider as a medically unbelievable error.

In October 2006, in response to public comments, CMS changed the definition of the GS modifier to “Dosage of EPO or Darbepoietin Alfa has been reduced and maintained in response to hematocrit or hemoglobin level.”

Discussion
Since the last modification to this policy in October 2006, there have been several publications and an FDA “black box” that emphasize the risks facing ESRD patients who receive large doses of ESAs and have higher hematocrits. In response to those concerns, we are modifying this ESA monitoring policy to provide greater restrictions on the amount of ESAs for which payment is made at higher levels of hemoglobin.

Policy
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 EPO warrants postponing requiring monitoring until the hematocrit reaches higher levels.

Effective for dates of service on or after January 1, 2008, for requests for payments or claims for ESAs for ESRD patients receiving dialysis in renal dialysis facilities and reporting a hematocrit level exceeding 39.0% (or hemoglobin exceeding 13.0g/dL) for 3 or more consecutive billing cycles immediately prior to and including the current billing cycle, the ESA dose for which payment may be made shall be reduced by 50% of the reported dose. In addition, claims must report modifiers ED or EE. Providers may continue to report the GS modifier when the reported hematocrit or hemoglobin levels exceed the monitoring threshold and a dose reduction has occurred. When the GS modifier is included on claims reporting modifier EE, the claim will be paid in full. The GS modifier, however, will have no effect on the 50% dosage reduction, or claims reporting modifier ED.

For dates of services April 1, 2006, and later, the Centers for Medicare & Medicaid Services (CMS) will not initiate monitoring until 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 should be reduced by 25 percent 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 EPO or Darbepoetin Alfa 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 reported dose by 25% from that reported on the claim. 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 on and after January 1, 2008, requests for payments or claims for EPO for ESRD patients receiving dialysis in renal dialysis facilities reporting a hematocrit level exceeding 39.0% (or hemoglobin exceeding 13.0g/dL) should also include modifier ED or EE. 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.”

Providers will report the GS modifier and the EE modifier when the reported hematocrit or hemoglobin levels exceed the monitoring threshold for less than 3 months and a dose reduction has occurred. When the recorded hematocrit or hemoglobin level exceeds the monitoring threshold for 3 or more consecutive billing cycles immediately prior to and including the current billing cycles, the provider will report the ED modifier and the claim will have an automatic 50% reduction in the reported dose applied, even if the claim also reports the GS modifier.

In addition, the medically unbelievable edit (MUE) threshold has been revised. The MUE for claims for Epogen is reduced to 400,000 units from 500,000 and to 1200 micrograms from 1500 micrograms for Aranesp®. Claims reporting doses exceeding the new threshold are assumed to have typographical errors and will be returned to providers for correction.

The table below outlines various scenarios:

Hct Exceeds 39.0% or Hgb Exceeds 13.0g/dL *ED Modifier? (Hct >39.0% or Hgb >13.0g >3 cycles) *EE Modifier? (Hct >39.0% or Hgb >13.0g <3 cycles *GS Modifier? (Dosage reduced and maintained) 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 ED or EE.

Yes

No

No

Yes

Return to provider for correction. Claim must report either ED or EE.

Yes

No

Yes

Yes

Do not reduce reported dose.

Yes

No

Yes

No

Reduce reported dose 25%.

Yes

Yes

No

Yes

Reduce reported dose 50%.

Yes

Yes

No

No

Reduce reported dose 50%.

These hematocrit requirements apply only to EPO or Aranesp furnished as an ESRD benefit under §1881(b) of the Social Security Act (the Act). EPO or Aranesp furnished incident to a physician’s service is not included in this policy. Carriers have discretion for local policy for EPO and Aranesp furnished as “incident to service.”

Maria Ciccanti
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