Annual Round of Proposed Changes to ESRD Program Includes Expected, and Unexpected, Proposals

Fourth of July weekend: parades, barbecues, fireworks—and the annual release of proposed revisions to the Medicare ESRD End-Stage Renal Disease (ESRD) Prospective Payment System (PPS) and Quality Incentive Program (QIP). On Wednesday, July 2, the Centers for Medicare & Medicaid Services (CMS) released its proposed rule recommending changes to the ESRD program, adding 359 pages of federal regulations to ASN’s Public Policy Board’s and Quality Metrics Task Force’s holiday weekend reading.

Since then, the task force and policy board assessed proposed changes to both payments for dialysis care and modifications to the mandatory quality program. Several key areas of interest—both positive and negative—are summarized here; further analyses will be posted on ASN’s website. The society will provide CMS with detailed recommendations for improvement to ensure patients continue to have access to the highest quality care possible within the Medicare ESRD program.

Key proposed changes to the bundle

Most of the changes CMS proposes for the payment bundle were codified in the Protecting Access to Medicare Act of 2014 (PAMA) statute, and, predictably, CMS’ interpretation of that law did not come as a surprise to the kidney community. Importantly, PAMA mitigated cuts that Congress had previously called for in the American Taxpayer Relief Act (ATRA)—cuts CMS had proposed to implement by reducing bundled payments by 12 percent. Many in the kidney community, including ASN, had raised serious concerns to Congress and regulators about the negative potential effects a cut of that magnitude could have on patient access to high-quality care, particularly in rural and inner-city areas.

Although CMS proposed to set the base rate for 2015 at $239.33—a zero percent update to the payment rate—the situation is not as dire for patients and providers as it otherwise would have been. Another noteworthy change CMS proposes to implement based on the PAMA statute is delaying adding oral-only drugs to the bundle until the year 2024, previously slated to begin in 2016.

CMS indicated that it would maintain the increase in the home dialysis training adjustment that it implemented last year. This increase brought payments up by $16.72, for a total training add-on adjustment of $50.16 per training treatment. ASN will continue to reaffirm the importance of home dialysis training and highlight how crucial sufficient home dialysis payments are to ensure patient modality choice and equitable access to home dialysis.

Key proposed changes to the Quality Incentive Program

In addition to recommending payment changes, the rule proposes modifications and additions to the ESRD QIP, which sets minimally acceptable patient outcome standards and mandates reporting on certain aspects of care. Under the QIP, facilities that do not meet the QIP’s standards for quality measures receive a payment reduction of up to 2 percent.

Given the limited scientific evidence currently available regarding what comprises optimal care for patients on dialysis, the society has voiced reservations about some aspects of the QIP and is likely to do so again this year. ASN will also call attention to measures that are overly focused on processes—such as monitoring and collecting data—rather than on outcomes that reflect quality and value.

One new issue the policy board and task force will be assessing this year is the relationship between the QIP program and another new dialysis facility quality evaluation program CMS recently announced: the Five Star Rating System. The proposed rule does not discuss the Five Star system, although the program appears to have some similar goals to the QIP, including providing information for patients and their families to compare facilities’ performance and quality of care. ASN and others will be seeking clarity on the Five Star program and its relationship to other programs, as well as assessing the new program in its own right.

CMS has hinted for several years that it would like to implement a Standardized Readmission Ratio (SRR) measure for dialysis facilities, and in this rule proposes adding the SRR in 2017. In concept, ASN strongly supports assessing hospital readmissions and believes such a measure would have great potential for improving patient care. But as with every aspect of quality measurement, the devil is in the details, and the society has numerous questions and concerns it believes must be addressed before the measure is finalized.

There are several challenges in methodology and other questionable aspects of the SRR measure that lack validity. One concern is defining the denominator as the number of discharges rather than by the total number of beneficiaries; this has the effect of allowing a single patient with repeated admissions to drive the entire performance of this metric. ASN also believes it is important that facilities have the opportunity to interact with patients before being held accountable for their readmissions.

“Unlike the proposed ESRD Seamless Care Organizations (ESCOs), which by design incentivize investment in elements such as hospital-based transition care coordinators to reduce readmission, dialysis facilities do not currently have such coordinators. Accordingly, if a discharged patient is readmitted prior to being seen at the dialysis facility, the facility would not have the opportunity to intervene to prevent the readmission,” said ASN Quality Metrics Task Force Chair Daniel E. Weiner, MD. This is one of many changes ASN will be encouraging CMS to consider should it move forward with implementing what is currently a flawed measure.

Notably, the SRR measure—in its current form—was not supported by the members on the Technical Expert Panel (TEP) that CMS convened to contribute expertise to its development, nor has the measure been endorsed by the National Quality Forum (NQF). Adopting NQF-endorsed measures is CMS’ stated preference, making its proposed adoption at this time unusual. The society is concerned that, ultimately, the TEP had little influence on or input into the measure’s development. This is one of several examples the kidney community has recently seen suggesting that the overall TEP measure development process is not functioning as well as possible, a concern ASN is working to address with CMS.

One positive change is CMS’ proposal to transition the anemia management measure (Hgb >12 g/dL) from a clinical measure to a reporting-only measure. ASN will commend CMS for this action in its comment letter. The society has advocated for removal of this unneeded clinical measure in the past for several reasons, including—as CMS acknowledged in the proposed rule—that the measure is “topped out,” with virtually 100% of facilities achieving the measure standards. Keeping topped out measures in the program dilutes the effectiveness of the more meaningful measures in the calculation of overall performance scores, and ASN generally supports a shift toward a smaller number of important measures.

Notably, CMS cannot completely eliminate an anemia measure from the QIP at this time because the Medicare Improvements for Patients and Providers Act (MIPPA) statute mandates that the QIP include a measure of anemia management in the QIP. Because CMS eliminated the low-end anemia management measure (Hgb <10 g/dL) several years ago and has not implemented any additional anemia management measures, it must maintain the Hgb >12 g/dL as a reporting-only measure to remain compliant with the law.

For calendar year 2018, CMS also proposes implementing a standardized transfusion ratio (STrR) that would include Medicare patients who have been diagnosed with ESRD for at least 90 days, along with many other patient exclusions/caveats. ASN has long advocated that CMS monitor unintended consequences that adversely affect dialysis patients, including transfusion rates. The policy board and task force are assessing the details of the proposed measure and will provide recommendations in the ASN comment letter. Please visit the ASN Advocacy and Public Policy website (http://www.asn-online.org/policy/) for more information on the proposed rule and to read the society’s final comment letter to CMS.