Nearly Half of Dialysis Clinics Do Not Specify Hemoglobin RangeOIG: Chains More Likely to Be Consistent with Anemia Drug Boxed Warning
11/10/2009
WASHINGTON—Only 56 percent of Medicare-certified dialysis clinics have anemia drug administration protocols in place that explicitly state a target hemoglobin range for patients, according to a recent government review of dialysis facilities.
Nearly all end-stage renal disease patients have anemia, which can be treated with erythropoietin-stimulating agents—such as Amgen’s Epogen and Aranesp or Johnson & Johnson’s Procrit.
“We could not determine whether the remaining 44 percent of protocols were consistent with the boxed warning and Medicare’s benefit policy because they do not specify a target hemoglobin range,” Stuart Wright, deputy inspector general for Evaluations and Inspection, Office of Inspector General, wrote in a Nov. 5 report.
The boxed warning for ESAs states dialysis providers should administer the anemia drugs “to achieve and maintain hemoglobin levels within the range of 10 to 12 grams per deciliter (g/dL).”
Medicare’s benefit policy reflects the range given on the warning, and the agency will reduce payments of hemoglobin levels exceeding 13 g/dL.
Rep. Pete Stark, D.-Calif, the chairman of the Ways and Means Health Subcommittee, asked the OIG to review ESA protocols after some members of Congress raised concerns that practices may not be consistent with current warnings for the drug.
Dialysis clinics, however, are not required by Medicare to develop protocols for ESA administration to CKD patients. If they do have protocols, they can define target hemoglobin levels and dosage instructions.
The OIG review from the Department of Health and Human Services looked into how many Medicare-certified dialysis facilities have protocols for ESA administration, determine whether these protocols are consistent with the black-box warning on ESAs, and figure out how the protocols conform with Medicare’s benefit policy for ESAs and payment monitoring policy for ESA claims.
The investigation found that chain dialysis facilities are more likely to be consistent with the ESA boxed warnings than nonchain facilities, according to the report. “Specifically, 97 percent of protocols from chain facilities are consistent with the warning, compared to 87 percent of protocols from nonchain facilities.”
On the other hand, the profit status, facility size or facility type (freestanding or hospital-based) did not have an affect on whether a clinic was consistent with the boxed warning, the report said.
In all, 93 percent of all dialysis facilities had some form of protocols in place for administering ESAs; 7 percent did not have any protocols in place, according to the OIG review.
Of the dialysis clinics with protocols, 94 percent are consistent with the boxed warning and the Medicare benefit policy for ESAs because the upper limit of the stated target range is equal to or less than 12 g/dL, according to the OIG report.
More than 90 percent of the protocols included information about when to increase, decrease and withhold ESA doses, according to the report.
* Sources: Office of Inspector General: Renal Dialysis Facilities’ Dosage Protocols for Administering Erythropoiesis-Stimulating Agents
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