ESRD Quality Incentive Program: ASN Provides Feedback on CMS Proposals

The Centers for Medicare & Medicaid Services (CMS) released its annual set of proposed updates and additions to the Medicare End Stage Renal Disease (ESRD) program for public comment in July 2012. The ASN Quality Metrics Task Force and Public Policy Board spent the summer analyzing the proposed rule’s potential impact on patient outcomes, access, and safety, and the integrity of the patient-physician relationship.

The society submitted feedback to CMS on August 31, 2012, emphasizing support for CMS’ goal of monitoring access to and quality of dialysis care within a bundled payment system, and providing suggestions for improvement to the agency’s proposals. ASN underscored the vital importance of only implementing measures that are substantiated by rigorous, scientifically validated evidence. ASN’s complete comments are available online; this article summarizes some key conclusions from the task force.

Although ASN supported several of CMS’ proposals related to the ESRD Quality Incentive Program (QIP), the society conveyed that, overall, the existing and proposed new measures for the QIP are not as relevant as others CMS might have suggested. Many measures focus on processes—such as monitoring and collecting data—rather than on outcomes that affect quality and value.

ASN encouraged CMS to ensure—to the extent possible—that existing and future measures be applicable for patients who dialyze via peritoneal dialysis, home hemodialysis, and other treatment strategies including daily and nocturnal dialysis. The society also recommended that CMS consider adding metrics to evaluate appropriate referral for transplantation, as well as appropriate choice of palliative care.

ASN was most concerned regarding CMS’ proposals to add a clinical hypercalcemia measure and to establish an overly ambitious performance standard for the percent of patients with a fistula. ASN also encouraged CMS not to implement its proposal to require facilities to report QIP data on 98 percent of patients, suggesting that a more reasonable alternative would be to consider only patients who received seven or more dialysis sessions per month eligible for QIP measures.

Mineral metabolism

CMS proposed expansion of an existing mineral metabolism measure and adoption of a measure assessing the number of patients with uncorrected serum calcium >10.2 mg/dL. ASN recommended that CMS not implement these suggestions, emphasizing that insufficient evidence exists to substantiate a 10.2 mg/dL calcium level.

“The only evidence supporting this benchmark is observational data, which is not sufficiently rigorous to substantiate an incentivized measure. Implementing this measure would effectively cement a practice based on observational data, impeding further progress toward generating more evidence regarding an optimal calcium level. Moreover, virtually every dialysis facility already collects serum calcium and phosphorus concentrations,” said task force chair Thomas H. Hostetter, MD. “Because compliance with this measure is already so widespread, expanded reporting to CMS that dialysis facilities collected the data is unlikely to lead to improved patient care or outcomes.”

Vascular access

ASN is committed to promoting patient access to the most appropriate type of vascular access, and was concerned that CMS proposed to set the bar too high for the number of patients with a fistula. The society urged CMS to reconsider its proposed standard to allow sufficient leeway between the maximum number of catheters and the minimum number of fistulas so as to not penalize facilities with patients who are appropriate candidates for grafts.

ASN suggested that CMS consider permitting patients who are not appropriate candidates for a fistula—owing to age, comorbid conditions, or limited life expectancy—to be excluded from the measure. This approach would help mitigate cherry-picking concerns for patients without fistulas.

Dialysis adequacy

CMS also proposed replacing a “dialysis adequacy” measure using urea reduction ratio with Kt/V. Although urea removal information is important, it does not provide the all-inclusive picture the phrase “dialysis adequacy” suggests. ASN suggested that the nephrology community collectively—including CMS—reframe the language that it uses to describe Kt/V, using an alternative term such as “urea removal.” This terminology shift would help the nephrology community focus on more comprehensive ways to monitor and improve the overall adequacy of dialysis therapy.

Anemia management

CMS did not propose any changes to the existing anemia management measure; however, ASN recommended that CMS consider assessing hemoglobin/hematocrit levels on a rolling 3-month or 6-month basis rather than assessing the levels on a monthly basis. Assessing a single value per month has limited clinical utility or insight into the quality of care that an individual patient receives in a dialysis facility. A longer assessment period would provide a more complete picture of patients’ overall anemia management.

Standardized hospitalization ratio

A standardized hospitalization ratio is one measure CMS is considering adding to the QIP in future years. However, ASN is concerned that this measure could make it challenging for patients with multiple comorbid conditions or generally compromised health to gain admission to a dialysis unit. The task force also concluded that it is currently impossible to accurately case-mix adjust for changes in patients’ comorbid conditions unrelated to dialysis. ASN suggested that CMS not implement the measure at this time, and at a minimum, pilot it before applying it to the entire ESRD patient population to assess whether these serious issues can be addressed.

“Hopefully, CMS will find ASN’s feedback informative and useful as it continues to develop the QIP,” Hostetter said. “A robust system assessing the accessibility and quality of dialysis services is critically important for our patients. Many challenges remain in developing an evidence-based system that accurately reflects the level of care offered, and ASN looks forward to continued interaction with CMS to make progress in this arena.”