By Peter Laird, MD
We are now a year into the social experiment we call the renal bundle where payments for all dialysis services are bundled into a single payment with disease modifiers and QIP matrices for quality care tied to the final payment. There is no doubt that the abuses of EPO and other separately billable items under the old payment system suffered from an extreme profit motive pushing EPO dosages higher and higher with no clinical benefit and indeed, many would rightly argue, great clinical harm to those at the high dosage end with elevated Hb levels over 12.0.
Medicare payment to ESRD facilities for outpatient maintenance dialysis services furnished to Medicare beneficiaries with End-Stage Renal Disease (ESRD) is based on a prospective payment system known as the basic case-mix adjusted composite payment system. The base composite rate covers the costs of the dialysis treatment and certain routine drugs, laboratory tests, and supplies furnished at home or in a facility. Other items and services, particularly injectable drugs (for example, erythropoietin (EPO), iron sucrose, vitamin D), and non-routine laboratory tests are not included in the composite rate and are billed separately to Medicare. Separately billable services represent about 40 percent of total Medicare payments per dialysis treatment. The base composite rate is adjusted by a drug add-on payment to account for changes in the drug pricing methodology that occurred in 2005 and by case-mix factors, that is, age, body size, and a special adjustment for pediatric patients.
Since the implementation of the prospective payment system, several reports are sending a mixed message of this "brave new world" we now know as the bundle. EPO utilization is dropping dramatically as are patients average Hb levels. The biggest news of the renal bundle in 2011 was the decision by CMS to drop the lower Hb target level of 10.0 leaving the door open for providers to adopt the pre-EPO modality of iron supplementation and rescue transfusions. The literature is repleat with the dangers of patients having Hb levels lower than 10.0. PTH levels are rising and uncontrolled secondary hypoparathyroid disease will result in a net increase in the need for parathyroidectomies to control this new epidemic. DOPPS has published an interim report on the effects of the bundle and continue to monitor it effects.
Trends in all patients: From Aug. 2010 to April 2011, average hemoglobin levels fell slightly (0.10 g/dL). The percentage of patients with hemoglobin >12 g/dL declined from 31.4% to 28.0%. The percentage with hemoglobin <10 g/dL rose from 8.5% to 10.0%, and the percentage with hemoglobin <9 g/dL was stable at ~2.7%. The average prescribed epoetin dose fell by ~3% and the average administered dose fell by 6%-7%, with a notable drop in the higher epoetin dose range. The percentage of patients prescribed injectable iron per month rose from 57% to 78%.
Mineral and bone disorder management
Trends in all patients: Overall, the average PTH level rose sharply from 337 to 435 pg/mL from August 2010 to April 2011, an increase of 29%. No substantial changes were seen in serum phosphorus or calcium values. The reasons for the rise in PTH are being investigated; large changes in use of injectable vitamin D or oral medications are not yet apparent.
The safety net of the bundle is an ongoing and developing quality indicator payment reduction system for failing to reach the minimum quality standards. Many are now decrying the fact that just measuring the indicators is enough to qualify for payment without actually addressing some of the measured indicators.
By Steven Fishbane, MD
The Centers for Medicare & Medicaid Services (CMS) published the final rule for the End-Stage Renal Disease Prospective Payment System and Quality Incentive Program (QIP) on Nov. 1. This follows the proposed rule that had been published in the Federal Register on July 8, 2011.
In this article, the focus will be on the ESRD QIP. There were 88 public comments received on the QIP, and the final QIP rule reflects important changes relative to the proposed rule. The greatest changes in the QIP will be for payment year 2014. It is critically important for providers to understand the 2014 QIP because, 1) it contains major changes from previous years and 2) the performance period begins very soon: Jan. 1, 2012. This posting is a summary of the major components of the final QIP rule, with changes from the proposed rule highlighted in italics.
Despite the alleged oversight through the QIP, a distressing essay written by a leading dietitian and posted by Gary Peterson in RenalWeb today depicts the desperate plight that the ESRD bundle is having on the dietitian profession who are admittedly one of the most important clinical partners in preventing complications of dialysis care. It is not only a call to arms for dietitians, but for all concerned about the care of dialysis patients in America. It is most importantly, a call to arms so to speak for all dialysis patients here in this nation as we see many of the improvements of the last three decades in pharmaceutical care slip through the bottomless pit of the ESRD bundle with QIP indices for Hb for instance with no minimum safety zone. Instead, for Hb, the patient is now at the mercy of their provider to consider what is their "healthiest" Hb levels without any guideline to say when low is too low.
MY FELLOW RENAL dietitian, if ever there was a time to stand up, make noise, and be heard, it is now. We as renal healthcare professionals can no longer sit by in the wings as Medicare and dialysis units make policies that negatively impact our patients’ lives and outcomes. I am outraged by the changes that I have seen in the past year. I am disappointed that policies are made and implemented without thinking about how they will affect those that we serve. I am disheartened that one day, I, a family member, or a friend will have to submit to the suboptimal care that these policies have created. We, as a profession, knew that there would be changes in how we treat our patients when the bundled reimbursement plan came into effect last year. I could never imagine the turn that it would take. . .
Finally, this summer, Medicare released its proposed QIP measures for 2013, which addresses bone mineral management. With the inclusion of phosphate binders into the bundled rate beginning in 2014, Medicare is proposing that units attest whether or not they are following disease markers. There is no proposal at this time on whether the unit is treating the disease. There is no mention of disease marker goal ranges, either minimums or maximums. There is no mention of accountability that medications to treat the disease are being used. I concede that we do not yet know the “ideal” ranges for calcium, phosphorus, and parathyroid hormone, but there is enough evidence to determine levels that we should not exceed without increasing morbidity and mortality in our patients.
Yes, we are entering a brave new world we call the ESRD bundle and to date, the data is not comforting. Prior to the final ESRD bundle rule, CMS had many open meetings and vast input from patients, physicians, health care providers and dialysis patient groups. The QIP was the safety net proposed by CMS to address the concerns of all involved and as congress sat idly by aloof to the outcry by many to intervene for patient safety, instead we entered quietly into this brave new world. If the latest report by the renal dietitians is any indication of where we are heading, then this brave new world may in fact be nothing more than a return to the dark ages of dialysis prior to when advances in pharmaceuticals ended many patients suffering. There is a dark cloud hanging over this nation in our dialysis centers and the QIP blindly measures the faltering indices but has no power to evoke change. A call to arms is our only choice at this point in time. It is no longer a time for complacency among dialysis patients or allied health care professionals.