Dialysis pay-for-performance looms

In an effort to improve outcomes at the nation's 6,000 dialysis facilities, Medicare plans to cut reimbursement rates up to 2% if the facilities perform poorly on an expanded set of quality metrics.

Despite pushback from providers on existing metrics, used only to rate facilities, a study highlighted “a massive fail” in achieving high performance on at least one key metric considered the standard of care for more than 20 years. “It makes me think there's something wrong with the system,” said Dr. Mahmoud Malas, author of a JAMA Surgery report on regional variation in quality for end-stage renal disease care.

Researchers and patient advocates say a number of systemic challenges limit providers' ability to deliver higher-quality care to end-stage renal disease (ESRD) patients. They include misaligned reimbursement incentives that still reward providers despite substandard care and a failure to address factors that prevent patients from following dietary guidelines or routinely showing up for treatments.

“The biggest concern for patients is, 'Can I work?' and 'Can I eat?' ” said Lori Hartwell, a former dialysis patient and founder of the not-for-profit patient advocacy group Renal Support Network. “There is not enough evidence for measures that could be truly meaningful from a patient's perspective.”

More broadly, there's concern over the nation's failure to address issues that are filling the pipeline with new dialysis patients, most of whom reach the end stage of chronic kidney disease only after years of poorly controlled hypertension and diabetes.

Poor coordination between primary-care doctors, nephrologists and vascular surgeons often leads to a failure to detect early signs of kidney disease, which would enable providers to get patients on a trajectory to avoid dialysis. “It's not one particular specialty,” said Malas, director of endovascular surgery at the Johns Hopkins Bayview Medical Center, Baltimore. “We are all responsible for this failure.”

Since the 1970s, Medicare has paid the bill for treating ESRD patients. Nearly 489,000 patients were in the agency's ESRD program in 2010, according to the U.S. Renal Data System, at a cost of $32.9 billion.

Patients with renal failure experience a depressing lifestyle change. Without a transplant, patients require dialysis to filter toxins from their body three times a week for the rest of their lives. Each treatment lasts about four hours. Transplanted kidneys could end dialysis, but only 17,105 kidney transplants occurred in the U.S. in 2014, according to the National Kidney Foundation.

Despite paying an average of $88,000 annually per patient, the mortality rate among dialysis patients is 7.4 times higher than the general population. The U.S. has one of the worst dialysis survival rates in the world. According to an analysis in the Journal of the American Society of Nephrology, 21.7% of U.S. dialysis patients die every year compared with 6.6% in Japan and 15.6% in Europe.

To improve quality in the program, the CMS last month proposed linking quality scores on a suite of indicators to reimbursement. The rule, which will go into effect Jan. 1, 2016, also said providers should anticipate new metrics being added to the ESRD Quality Improvement Program in future years. Comments on the proposed changes will be accepted through Aug. 25.

Eleven measures are currently evaluated in the quality program. The eight clinical measures include using the best vein access method (arteriovenous fistula) instead of catheters; the adequacy of toxin filtration during dialysis, which is closely associated with time in the clinic; infection rates; anemia and calcium management; and patient experience.

The CMS plans to add quality-of-life measures and readmission rates in 2018. In 2019, the CMS will add seasonal flu vaccination and ultrafiltration rates. The latter is a process that removes excess water and sodium from the body.

Several of the proposed measures have drawn fire from kidney-care quality researchers and providers. For instance, a draft report issued last month by the Renal Standing Committee of the not-for-profit National Quality Forum, which endorses consensus standards for performance measurement, rejected the CMS' proposal to include ultrafiltration as a metric. Although high ultrafiltration rates are associated with a greater risk of all-cause and cardiovascular deaths, patients “may be dying not because we are ultrafiltering them more, but because they have physiologies that make them more dangerous patients,” said nephrologist Dr. Alan Kliger, chief quality officer for Yale New Haven (Conn.) Health System.

The NQF also declined to recommend a metric that looks at patients having too much calcium, a problem associated with high mortality rates.

That lack of consensus over metrics has led to questions by some providers about how effective they are. A 2% reduction is a “substantial issue all providers take seriously,” said Dr. Frank Maddux, chief medical officer of Fresenius Medical Care, one of the two largest U.S. dialysis providers. If the measures are not aligned with the state of the science, “then we aren't spending our time on those things that are most important.”

The CMS says it has taken a “conservative approach” in applying quality measures to payment adjustment.

While providers will raise their concerns during the comment period, there's concern over the dialysis industry's failure to provide the standard of care on long-established metrics closely associated with better outcomes.

Malas' study in JAMA Surgery last month noted that many kidney-failure patients continue to receive critical dialysis treatments through catheters, a vein access method widely known to increase infection risk, blood clots and death. Fistulas, the preferred method, are not used in a quarter of the nation's dialysis patients, according to estimates. Each hospitalization for catheter-related infections costs an average of $23,000. Reducing catheter use by half could yield $1 billion a year in Medicare savings, according to a 2011 article in the Journal of the American Society of Nephrology.

“It's both surprising and disappointing,” Malas said. “We know fistula use is associated with the best outcomes.”

The CMS began publicly rating dialysis providers based on performance on the available metrics using a five-star system rolled out in January. Transparency is a great step forward, said Hartwell, who was on dialysis for 13 years before receiving a kidney transplant.

Patient advocates are most concerned about issues that drive people away from the clinics. “You can have a ton of measures, but the real key is to strike a good balance for what is meaningful for patients,” Hartwell said. “Once the community starts to look at that, they'll understand why patients want to shorten their treatments or don't want to show up.” l