On Jan. 1, Medicare Part B began including coverage for renal dialysis services furnished by a facility or provider for a Medicare beneficiary with acute kidney injury (AKI). The Centers for Medicare & Medicaid Services estimates that approximately $2 million in calendar year 2017 will shift from hospital outpatient departments because of AKI patients receiving kidney care in freestanding dialysis facilities.

In the CMS-prepared regulations, the agency defines an AKI patient under the new benefit as an individual who has acute loss of renal function and does not receive renal dialysis services in a hospital. We think the definition — and the approach to care for these patients — will be more complicated, so we asked Robert Provenzano, MD, FACP, FASN, Vice President of Medical Affairs in the Office of Chief Medical Officer at DaVita Kidney Care, and an NN&I Editorial Advisory Board member, and Glenda Payne, MS, RN, CNN, Director of Clinical Services for Nephrology Clinical Solutions, to dissect the new law and offer their views on how it will impact the renal care team in the outpatient dialysis setting.

We also provide additional information on the history of the legislation and how services will be reimbursed to dialysis providers under the new law.

NN&I: How would you characterize the best AKI candidate for outpatient dialysis care?

Robert Provenzano, MD, FACP, FASN: The goal of providing acute kidney injury (AKI) patient treatments in the outpatient setting is to allow otherwise “stable” hospitalized patients who would, except for the need for dialysis, be sent home to convalescence. Therefore, non-stable patients that do not meet existing facility admission criteria may not be accepted for treatment in outpatient dialysis centers. I do not anticipate any changes to that existing criteria.

NN&I: Will most of these patients be coming from rehab facilities, skilled nursing facilities, etc.? How many AKI patients might a typical outpatient dialysis facility see in a given year?

Provenzano: There are many unknowns as we move forward with providing outpatient dialysis services to these patients. DaVita Kidney Care’s analysis suggests 1-5 patients/facility. This number is extrapolated from historical data, but may be an underestimate if hospitals pressure nephrologists to more quickly to discharge AKI patients, or if the diagnosis of AKI is “broadened” to encompass ultrafiltration failures (congestive heart failure, cirrhosis, etc.).

As to patients in SNFs or rehab centers with AKI, if they meet admission criteria to the dialysis facilities, I see no reason why they would not be accepted for treatment.

NN&I: For physician payment, will these patients fit under the monthly capitated payment as outpatient dialysis patients, or will physician practices still be using hospital billing codes?

Provenzano: It is important to stress that these patients are not ESRD patients. The diagnosis of AKI has different clinical care requirements. Nephrologists therefore may not utilize MCP codes, rather they may, per CMS directives, use the hospital codes for acute dialysis based on the work they perform when caring for these patients in the outpatient facility.

NN&I: From a nursing perspective, how would you define the difference in care for these patients vs. those who are already in the outpatient setting?

Glenda Payne, MS, RN, CNN: The major difference in these patients and other patients new to dialysis is that the AKI patient is more likely to recover kidney function. This means that the care team must pay even more careful attention to fluid removal — avoid removing too much fluid at one time — and monitor the patient closely for return of native kidney function.

NN&I: Do you think the outpatient nursing staff will have the skill set to care for these sick patients?

Payne: I would expect that AKI patients who are critically ill will be cared for in the hospital setting, and only discharged to an outpatient facility when they have improved sufficiently to be cared for at home.

I don’t believe caring for the AKI patient in the outpatient setting requires any change in skills, but perhaps a change in focus. Nurses who have embraced the concept of patient-centered care will recognize that the monitoring parameters and goals for the AKI patient will need to be different from those for the ESRD patient. The AKI patient may need additional lab studies if his/her native kidney is regaining function, as well as a varied schedule of dialysis as native kidney function increases or decreases. These patients will need education and support, which will be a role for the whole interdisciplinary team.

NN&I: AKI patient will likely require more frequent treatments than the typical patient on dialysis. How might this impact staff-to-patient ratios and how Medicare surveyors will evaluate this care? Will treatment of these patients be evaluated under the Conditions for Coverage? Are they included in the Quality Incentive Program?

Provenzano: More frequent treatments typically occur when patients are hyper-catabolic and unstable, usually while hospitalized. Our data shows that AKI dialysis prescriptions were 3 treatments/week when hospitalized and in fact many were receiving 2 treatments/week. This may be due to the patient recovering renal function.

The Conditions for Coverage were last updated in October 2008 and AKI was not included. so there is no regulatory direction here. That said, facility medical directors are responsible for all patients and by inference would/may be responsible for the AKI patients.

Payne: The Medicare regulations do not address staffing ratios, but do require “an adequate number of qualified personnel…so that the patient/staff ratio is appropriate to the level of dialysis care given and meets the needs of patients.” Medicare surveyors evaluate staffing adequacy by observations (e.g., whether alarms are answered promptly, and patient requests addressed) and by review of records (whether vital signs are monitored according to policy). For states that have staffing ratios included in ESRD licensing rules, it is likely that staffing for the AKI patients will be expected to meet those same ratios.

According to the final rule, no changes were made to the Conditions for Coverage, other than to extend the requirements outlined in the CfC to AKI patients. So the same level of care would be expected to be provided for AKI patients, which means the full interdisciplinary team will be expected to participate in the assessment and plan of care for these patients. As a former surveyor, I would expect most of the AKI patients would be considered “unstable” and would require a monthly update of the plan of care. Given that the course of AKI is likely to be less than 90 days, this should not be too great a burden on facilities.

The final rule was clear that AKI patients are not included in the population of patients whose care is evaluated via the QIP. So, these patients should not be included in the data reporting for the QIP.

NN&I: In summary, what do you see as the benefits and pitfalls for this new option — for patients as well as providers?

Provenzano: I applaud CMS’ decision to no longer allow AKI patients to languish needlessly within the hospital setting. This is both financially responsible and clinically responsible, given both safety and infectious risks within hospitals.

That said, as with many well-intentioned decisions, there are many unknowns. AKI is a broad based, non-specific diagnosis encompassing many other primary disease processes. It will be important to monitor this patient cohort, much as we do with ESRD patients, to better understand the following: 1) What are the underlying etiologies of the AKI diagnosis? 2) What are the recovery rates and when does that occur? 3) What is the burden for care for these patients, for nurses, and for nephrologists? 4) Does allowing care in the outpatient setting offer a survival advantage or decreased hospital re-admissions? 5) What is the actual cost of caring for them in the outpatient setting?

As we have with ESRD patients, I expect we will soon better understand these patients, allowing providers to better tailor care to their needs.

Payne: The benefits for AKI patients include a more convenient location for dialysis, likely reduced travel time, more flexibility in scheduling, and a non-hospital environment. However, the pitfalls may be the potential failure by the outpatient staff to monitor patients for the return of kidney function, and the potential failure to identify and address different needs of the AKI patient vs. the ESRD patient.

For the provider, the new AKI rule is a clear pathway for payment for care of AKI patients, and provides continuity of care from the hospital to outpatient setting. Pitfalls may center on whether there is prompt and clear communication between the hospital and outpatient facility. This continues to pose a challenge for ESRD patients and will be critical for AKI patients.

For inpatient dialysis units, this new law will reduce the burden the hospital dialysis staff face when placing these AKI outpatients into a schedule filled with more critically ill inpatients. It will also help to relieve the cost burden, since hospitals frequently have had no way to bill for many of the expenses of caring for AKI patients. The new law will also reduce the dilemma hospitals have faced in navigating the “less than clear” CMS rules and regulations that govern the difference between inpatient and outpatient treatments.