Measuring quality is important in dialysis care, and payers, including Medicare, have the right to know how well their customers are being treated. But dialysis providers and professional groups are questioning whether current quality measures for outpatient dialysis patients are a good fit for evaluating patients with acute kidney injury.

AKI patients in the outpatient setting

Care for AKI patients became a new segment of a dialysis clinic’s patient population this year, when Medicare Part B began including coverage for renal dialysis services furnished by a facility or provider for a Medicare beneficiary with AKI. The Centers for Medicare & Medicaid Services estimates that approximately $2 million in 2017 will shift from hospital outpatient departments because of AKI patients receiving kidney care in freestanding dialysis facilities.

Legislation to allow AKI care in outpatient clinics was approved in 2015, initially tagged on as a rider to the Trade Preferences Extension Act of 2015, and the law took effect January 1.

While there is as yet no change to the ESRD regulations used by state surveyors, the reimbursement side of CMS has indicated that dialysis providers will be allowed to bill for more than three treatments per week if needed, without medical justification. Additional laboratory tests or pharmaceuticals necessary for the care of an AKI patient may be billed outside the dialysis composite rate, as well as other treatment-related expenses AKI patients may incur.

CMS defines an AKI patient in these regulations as “an individual who has acute loss of renal function and does not receive renal dialysis services for which payment is made under (the ESRD program).” The new benefit does not provide Medicare coverage for any patient diagnosed with AKI. This benefit only applies to those AKI patients who are already Medicare eligible (e.g., due to age or disability).

How to measure quality of care?

On June 29, CMS released its proposed rule for determining dialysis clinic payment for 2018, along with updates to its Quality Incentive Program. Although the agency had released regulations and guidance for treating AKI patients in the outpatient setting prior to the law taking effect in January, it needed to address payment for AKI patients. For CY 2018, the proposed AKI base rate is $233.31, the same for patients diagnosed with end-stage renal disease.

Thus, with a somewhat “standardized” approach to payment rules, CMS says it believes AKI patients might also face the same rules for evaluating quality as typical dialysis patients.

“As a result of this change in the law, we believe that we now have authority to include this population in the measures we use for the ESRD QIP,” CMS wrote in the proposed rule. “We believe that it is vitally important to monitor and measure the quality of care AKI patients receive. We are seeking comment in this proposed rule on whether and how to adapt any of our current measures to include this population. We are also seeking comment on the types of measures that might be appropriate for future inclusion in the program that would address the unique needs of beneficiaries with AKI.”

Not one in the same

It’s not that simple, said dialysis providers and renal associations in comments to CMS during the proposed rule’s review period.

“RPA believes the paucity of AKI data must be addressed before appropriate, feasible and valid AKI measures can be developed,” wrote Renal Physicians Association president Michael D. Shapiro, MD, MBA, FACP, CPE, in an Aug. 27 letter to CMS Administrator Seema Verma, MPH. “Given the variability of AKI patients as well as the lack of clinical practice guidelines related to AKI, it will be challenging to develop outcome measures.”

Part of the problem in assessing the quality of care, said Shapiro, is that AKI patients are seen in outpatient dialysis facilities for a limited time, usually less than three months.

“Frequently, the patients have been recently discharged from the hospital resulting in low hemoglobin, have low serum albumin reflecting protein malnutrition, and have multiple active medical conditions which may result in re-hospitalization,” he wrote.“…Since any dialysis unit is unlikely to have many AKI patients over the course of a year, the denominator in any individual dialysis unit will be extremely low, making meaningful evaluation of quality metrics in these patients difficult. The nature of the patients discharged from hospitals with AKI is so heterogeneous that data could not be interpreted as to quality of care.”

Other organizations raised similar concerns, suggesting that CMS consider starting with a fresh sheet of paper in developing quality measures unique to the characteristics of the AKI patient.

“ANNA concurs with the provision of care to AKI patient in outpatient dialysis clinics, and we appreciate that the Agency has provided a payment mechanism for care of these patients in dialysis clinics,” wrote Alice Hellebrand, MSN, RN, CNN, in a Aug. 28 letter to Verma. “…However, we agree with the kidney community that it would not be appropriate for the Agency to use any of the current ESRD quality measures, modify any existing ESRD measures, or create new AKI-specific measures for inclusion in the ESRD QIP.

“ANNA wishes to emphasize that AKI patients are unique and distinct from ESRD patients, and therefore none of the existing QIP measures or modifications to those measures are appropriate for inclusion in the QIP,” wrote Hellebrand. “Indeed, as the Agency clearly stated in the 2017 ESRD PPS and QIP final rule: ‘We continue to believe … that AKI patients have various treatment needs and outcomes that may not be the same as an ESRD patient. We acknowledge that this distinction between the two populations is important.’

“Unlike ESRD, where patients receive a chronic, ongoing course of life-sustaining dialysis, the primary objective for treatment of AKI patients is to stabilize their kidney function and transition them entirely off dialysis treatment,” said Hellebrand.

ANNA also notes that the specialized care for AKI patients means nurses need unique skills. “Specifically, nephrology nurses must employ more intensive oversight and enhanced intervention when treating AKI patients compared with treating an established ESRD patient,” said Hellebrand.

“For example, AKI patients require more vigilant monitoring, particularly in infection prevention, blood pressure control, more frequent laboratory testing, additional medication administration, and increased educational needs. The care of an AKI patient often requires more coordination of the interdisciplinary team. These are not patient care responsibilities that can be delegated to technicians or other staff; only specialized nephrology nurses can provide the type of highly intensive and coordinated care that is necessary for these patients to achieve improved health outcomes.”

Read comments from dialysis providers, renal associations, and individuals on CMS’ proposed 2018 rule for the Prospective Payment System and the Quality Incentive Program here.