Introduction of the federal government’s prospective payment system for dialysis care (“bundling”) on January 1, 2011 has brought about a new frugality and cost-consciousness in the use of medications and other resources in the management of patients with end-stage renal disease (ESRD). Dialysis providers were now being challenged to control costs—especially those associated with medications—while providing quality care.

“As a result of the bundle, medicines suddenly became a cost center versus a profit center,” said John Burkart, MD, Chief Medical Office for Health Systems Management at Wake Forest University Medical Center in Winston-Salem, North Carolina, who oversees the university’s outpatient dialysis facilities.

Faced with fixed payments for services, dialysis providers starting taking a hard look at whether one medicine really is more beneficial than another, or whether prescribing medications to achieve the highest possible value of a laboratory metric makes a meaningful clinical difference.

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“The pharmaceutical industry adjusted to that and changed the way things were packaged, changed the way things were marketed, changed what was available for a dialysis unit, whereas before maybe it wasn’t available for a dialysis unit.”

Rob Chioini, Chief Executive Officer for Rockwell Medical, Inc., a maker of dialysis products, noted, “As a pharma company, we started looking for products or ways that could demonstrate cost savings to providers while still improving patient outcomes.”

“I think bundling gave us the first look at what happens when you’re held accountable for clinical outcomes and for resource stewardship,” said Allen R. Nissenson, MD, Chief Medical Officer of Kidney Care for DaVita HealthCare Partners, Inc. The introduction of bundling has encouraged dialysis providers to focus on how they can achieve the best patient outcomes while restraining costs, he said.

“The challenges around a bundled system’s payment constraints are balanced by the move toward value-based care models,” said Franklin W. Maddux, MD, Executive Vice President of Clinical & Scientific Affairs and Chief Medical Officer for Fresenius Medical Care North America. “These new models afford the ability to add innovation investments that address the greater risk and responsibility providers assume in managing the total cost of care for our patients.”

The bundled payment includes all renal dialysis services provide for outpatient maintenance dialysis, including drugs and biologicals (except oral-only medications until 2025) and other renal dialysis items and services that used to be payable separately. The Centers for Medicare & Medicaid Services (CMS), which oversees reimbursement for dialysis care, said it expects to pay about $9 billion to approximately 6000 dialysis facilities in 2017 for costs associated with the provision of dialysis care. The bundle base rate for 2016 was $230.39; the proposed base rate for 2017 is $231.04. The bundled payment is case-mix adjusted for various factors relating to patient characteristics. CMS also makes facility-level adjustments for dialysis facilities that have a low patient volume or rural locality.

Shift in medication use

In the 6 years since bundling debuted, changes have occurred in the pharmacologic treatment of ESRD complications, especially anemia. Use of erythropoiesis-stimulating agents (ESAs) has decreased substantially. 

“The price of ESAs didn’t change, but the amount used was cut in half,” Chioini said.

“ESAs are the most costly of the injectable drugs. Its use has definitely gone down across the industry,” Dr Nissenson said. Innovation in anemia management has driven this with no evidence of changes in clinical outcomes, he added.

Researchers who have studied the impact of bundling on dialysis care cite the flat-rate reimbursement as a contributing factor to a decline in ESA use, along with FDA revisions to ESA labeling that encouraged more conservative use of these drugs. Concomitant with the decline in ESA use was a decrease in mean hemoglobin levels among dialysis patients.

“In terms of anemia management, the biggest trend by far is a substantial drop in mean hemoglobin levels since the advent of the bundle,” said James Wetmore, MD, MS, Medical Director for Nephrology Research for the Chronic Disease Research Group at Hennepin County Medical Center in Minneapolis. The bundle itself is not solely responsible for this, he stated. Key studies in pre-dialysis chronic kidney disease patients suggested that enthusiasm for high Hb levels probably was misguided, and thought leaders began to embrace lower levels. The FDA label change for ESAs also likely contributed to decreased enthusiasm for ESAs. As a result, ESA use is down and dialysis patients have lower hemoglobin levels and are receiving more transfusions compared with before the bundle,” Dr Wetmore said.

More hospital transfusions

Indeed, in a recent study examining the effect of bundling on anemia management in dialysis patients, Dr Wetmore and colleagues found that the number of blood transfusions administered in hospital emergency departments or during inpatient stays increased 13.9% and 26.4%, respectively, from 2009 to 2011, according to a report in BMC Nephrology (2016;17:53). The finding provides “some evidence for a partial shift in the cost and site of care for anemia management from dialysis facilities to hospitals,” the investigators concluded.

Shifts in the pharmacologic treatment of secondary hyperparathyroidism also have occurred since bundling went into effect. These include a trend towards increasing use of oral 1,25 vitamin D compounds, such as rocaltrol, as a replacement for IV-administered 1,25 vitamin D compounds, Dr Wetmore said. “This may be because oral vitamin D compounds are less expensive and … traditional IV 1,25 D compounds are contained in the bundle.”

New medicines introduced

Since the debut of bundling, new medications have been approved for managing end-stage renal disease complications. These include ferric pyrophosphate citrate (Triferic), which FDA approved in January 2015 to maintain hemoglobin levels in dialysis patients. The drug became commercially available in late 2015. The drug’s maker, Rockwell Medical, developed the drug to deliver iron safely and improve patient outcomes while also providing a more cost-effective way for providers to deliver iron (via dialysate), Chioni said. Clinical data has shown the drug can replace IV iron as a maintenance therapy and maintain hemoglobin concentration while significantly decreasing the need for ESAs and the dialysis center staff time required to give IV iron injections, he said. In the PRIME study, published in Kidney International (2015;88:1187-1194), Triferic use demonstrated a 35% reduction in prescribed ESA dose compared to placebo. The CRUISE studies showed that patients on Triferic were able to maintain their hemoglobin without receiving IV iron and without a change in ESA dose.

Cost savings

According to Rockwell, a 2% reduction in ESA dose would result in an approximately $156 savings per patient annually, and cutting down on IV iron injections could trim approximately 3 million registered nurse hours in the United States, an estimated cost of $200 million.

All patients lose iron at every dialysis treatment, Chioini said, and Triferic is needed to replace that iron loss real-time (similar to how magnesium, calcium and potassium are replaced at every treatment). Therefore, all patients should receive the drug as an iron maintenance therapy to maintain hemoglobin. If a patient has bacteremia, fungemia, or sepsis and the doctor wants to exclude iron for the patient, Chioini stated, then the bicarbonate line to the dialysis machine is simply is turned off and a jug of standard liquid bicarbonate is used.

“Triferic uptake will be interesting to observe,” Dr Wetmore said. “This drug has promising clinical effects, but the tradeoff providers make is whether the cost of the medication will offset the savings induced by ease-of-use and the concomitant reduction in time required by staff. The drug must be priced sufficiently aggressive before providers will actually realize the savings conferred by ease of use.”

Another drug to become available since bundling debuted is ferric citrate (Auryxia), an oral drug approved for use in 2014 as a phosphate binder in dialysis patients. The drug also increases iron stores, suggesting it could be useful in treating iron-deficiency anemia.

In February, FDA approved etelcalcetide (Parsabiv), a novel calcimimetic indicated for the treatment of SHPT in dialysis patients. It is administered intravenously after each dialysis session. In studies, etelcalcetide reduced parathyroid hormone and corrected calcium and phosphate levels. “Its uptake will depend on its real-world effectiveness beyond clinical trials as well as how long it remains outside the bundle,” Dr Wetmore said.

Home dialysis

Bundling also may have set in motion a trend toward greater use of home dialysis. Following the introduction of bundling, Dr Burkart said he observed a slight uptick in the number of patients starting renal-replacement therapy on home dialysis—especially peritoneal dialysis (PD)—rather than in-center hemodialysis. Prior to bundling, he said, dialysis providers had the potential to make more money with hemodialysis patients because of greater use of intravenous (IV) medications compared with PD. When these IV medications became part of the bundled payment, “providers recognized more of a balance between payment for services and modality choice, which when combined with emerging clinical data, and the transfer of some of the financial risk to the providers, favored the use of home dialysis,” Dr Burkart said.  “All of a sudden there was a desire by many providers to do more home [dialysis] than was done previously.”

National statistics do show an increase since bundling debuted. In 2010, 92.2% of ESRD patients started RRT with HD and 6.7% started on PD, according to the US Renal Data System. The proportions were 87.9% and 9.3%, respectively, in 2014.

In the Wake Forest system, the proportion of patients starting on PD rose from 16.5% before bundling to 18.4% currently, Dr Burkart said.

He pointed out that clinical data suggest home dialysis would be a more appropriate therapy than in-center HD for a much larger percentage of the ESRD population than it is currently. He also observed that “physicians and providers are now embracing these data and trying to optimize clinical outcomes and patient quality of life while on dialysis. This often favors use of home dialysis.”

Dr Wetmore said he observed an increase in PD use right after bundle implementation, but this has slowed. “There are some suggestions that the recent apparent shortage of PD fluid and associated changes in PD fluid pricing may have impacted this trend. Of course, no one knows what the ‘right’ percentage of patients on PD should be.”

Fresenius’ Dr Maddux observed: “Home therapies for dialysis patients continue to rise and have the opportunity to grow further. That includes developing more patient-friendly and connected health options for helping home dialysis patients maintain that modality for longer times.”

Dr Maddux noted that that home dialysis is associated with high attrition rates and that Fresenius is “determined to help alleviate the churn that can exist between some modalities for renal-replacement therapy.”

Dr Nissenson, of DaVita, said his company has had steady growth in the use of home dialysis, even before bundling. “We’ve always believed that home therapy is a good choice for the right patients.”

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