HCFA'S New EPO Reimbursement Policy Focuses on Patient Quality of Care

Introduction

The US Health Care Administration (HCFA) has replaced Medicare's Hematocrit Measurement Audit (HMA) with a new post-payment mechanism for EPOGEN(Epoetin alfa) claims. As originally implemented in September, 1997, the HMA process was confusing and controversial.

When HCFA reviewed the initial impact of the HMA, the data showed that the progressive improvement in hematocrit (Hct) among treated patients had stopped. As a result, the federal agency is now encouraging clinicians to maintain their patients within the National Kidney Foundation-Dialysis Outcomes Quality Initiative (DOQI)-recommended target Hct range of 33%-36% or hemoglobin (hg) range of 11-12 g/dl (the EPOGEN package insert recommends a target Hct range of 30%-36%). This is clearly in line with HCFA's initiatives to improve quality of care. HCFA has also reinstated medical justification to allow coverage for those patients that will clinically benefit from an Hct greater than 36% as determined by their physicians.

New Policy

On June 19, 1998, HCFA issued a Program Memorandum announcing changes to the reimbursement policy for EPOGEN. The new policy replaces routine pre-payment review of claims for EPOGEN with post-payment review, when indicated. Medicare's Fiscal Intermediaries (Fis) are instructed to override the HMA edict contained in the intermediary standard system [Fiscal Intermediary Standard System (FISS), formerly the Florida Shared System, and the Arkansas Part A Standard System]. The 90-day average Hct will no longer be calculated prior to payment when a patient's Hct exceeds 36%. Nor will the claim be subject to partial payment if the 90-day average Hct exceeds 36.5%.

Now, HCFA is instructing Fis to conduct post-payment reviews when a unit has an atypical number of patients with Hct levels above a 90-day rolling average of 37.5%. The agency is encouraging clinicians to maintain patients in the DOQI-recommended Hct range of 33-36% or hg range of 11-12g/dl. HCFA recognizes the variability in patients' Hct response and, therefore, decided to use a 90-day rolling average threshold of 37.5% to screen for dialysis centers reporting unusually high hematocrit values.

Medical Justification

The Fis are instructed to conduct routine medical review activities such as educational efforts or pre-payment reviews for those units found to have an atypical number of patients with a 90-day average Hct levels above 37.5%.

HCFA will also be developing a national policy for medical justification for patients whose Hcts need to be maintained above 36%. If a nephrologist determines that this medically necessary, he/she should have documentation available in the patient's record supporting the need for a higher Hct. The higher Hct payment is subject to a documentation review and must be acceptable to the FI.

Due to the revisions to EPOGEN reimbursement, HCFA is also allowing resubmission of EPOGEN claims for billing periods beginning on or after March, 10, 1998, that were previously denied based on Hct levels.

Implications For Dialysis Units

In accordance with the HCFA Hct/hg recommendation, dialysis units may want to:

• Review their protocols to ensure they have the appropriate target Hct/hg ranges; and
• Review methods for monitoring a patient's Hct/hg and for titrating EPOGEN doses appropriately.
• With the reinstatement of medical justification, physicians can help their patients whom they deem will benefit medically to be maintained above 36% Hct or 12 g/dl hg. They can:
• Identify any patients whom the nephrologist believes should be maintained above 36% Hct or 12 g/dl hg.
• Follow up with the FI to determine the appropriate documentation required to maintain patients above 36% Hct or 12 g/dl hg.
• Establish a documentation policy for any patients who are maintained above 36% Hct or 12 g/dl hg. This should include physicians' orders with a specified target hematocrit/hemoglobin level and the specific medical condition or circumstances justifying a higher Hct/hg. The order should be followed periodically with supporting notes.
• HCFA is applying this new policy to claims submitted on of after March 10,1998, that were denied based on Hcts. If dialysis unit personnel submitted a claim for services provided on or after March 10 and were denied based on Hct/hg levels, they can resubmit the claim for payment.

Conclusion

The new Medicare policy for EPOGEN reimbursement provides clinicians with the ability to improve dialysis patient outcomes. Clinicians can better manage anemia within the variability of Hct/hg measurements in the setting of post-payment Hct review and a 90-day rolling average threshold of 37.5%. By endorsing the DOQI-recommended Hct/hg levels, HCFA acknowledges the clinical benefits for patients at the 33%-36% Hct or 11-12 g/dl hg level.

In this new policy for EPOGEN, HCFA has changed its focus to the quality of care for dialysis patients. It is important for the renal community to continue to work with HCFA to ensure that, as the agency elaborates on the End-Stage Renal Disease (ESRD) policy, it takes into account the impact on the patients.