While there were very few changes from the proposed rule to the final rule of the 2014 edition of the End Stage Renal Disease Quality Incentive Program, dialysis providers and renal associations sent some strongly worded statements on why certain measures just weren’t ready for prime time. CMS made efforts to address them in comments contained in the final rule.

(Finding the good news in the ESRD PPS final rule)

CMS released the proposed changes to the QIP on July 8 with a comment period that ended Aug. 30. In the proposed rule, CMS outlined new clinical and reporting measures, proposed expansion and revisions of existing measures and refinement of the scoring methodology, offered ways to modify the program's public reporting requirements, and noted efforts to continue the data validation pilot program.

CMS received 55 public comments on these proposals, a small percentage of the overall more than 1,000 comments received on the ESRD PPS changes. Comments came from the renal community and the Medicare Payment Advisory Commission (MedPAC).

Below are some of the comments, and CMS' response.

Origins of quality measures:For the payment year 2016 ESRD QIP and future payment years, CMS proposed 14 measures. But the dialysis provider community raised questions about the use of measures that did not come directly from the National Quality Forum. In fact, four of the five new measures proposed for the PY 2016 ESRD QIP are not endorsed by the NQF. Commenters said measures that are only “based on” NQF-endorsed measures lack credibility. Some commenters recommended adopting the NQF-endorsed versions of the measures instead of the versions that CMS proposed to adopt in the proposed rule.

(CMS makes only minor changes in final ESRD QIP rule)

CMS response:One of the five newly proposed clinical measures is on measuring hypercalcemia, and has been NQF-endorsed. Another one of the newly proposed clinical measures, the NHSN Bloodstream Infection in Hemodialysis Outpatients, is not substantively different than NQF-endorsed measure #1460, CMS said. The agency noted that it declined to finalize several proposed measures do to public comments, including:

  • A comorbidity reporting measure
  • An anemia management clinical measure that would require facilities to notify patients about how they are being treated for anemia
  • A reporting measure for pediatric ESRD patients to monitor iron therapy  

Incentive to improve quality vs. a punitive payment system: One commenter urged CMS to find a way to incentivize quality attainment and improvement rather than solely focusing on penalizing facilities when they don’t reach the required performance score.

CMS response: “We do not have the statutory authority to award bonus payments to facilities for high performance under the ESRD QIP. Furthermore, we continue to believe that the structure of the ESRD QIP appropriately incentivizes improvements in the quality of care for patients with ESRD.”

Too many performance measures:Several commenters expressed concerns that the ESRD QIP is adopting too many measures. “These commenters noted that as more measures are adopted, the importance of any single measure to a facility’s payment is reduced. The commenters also noted that CMS established criteria for retiring an ESRD QIP measure in the PY 2015 ESRD QIP, and the commenter is concerned that CMS has yet to propose the removal or retirement of any ESRD QIP measure while simultaneously continuing to propose the inclusion of new measures with little relative impact on patient outcomes.”

(QIP tracks performance, but are the measures improving patient care?)

CMS response:“We recognize that as more measures are added to the ESRD QIP, the significance of a facility’s score on any single measure in relation to the overall [total performance score] is reduced…We are currently in the process of evaluating all of our ESRD QIP measures…and based on our findings, we will consider removing or replacing one or more measures next year.”

Accepting grafts as a "quality improvement" effort:Several comments on the proposed rule covered this topic. Providers believe that synthetic grafts—not just arteriovenous fistulas—are an acceptable improvement over maintaining ESRD patients on a catheter, and grafts should be included as part of the access clinical measure.

CMS response:“We are aware of the concern relating to the lack of a graft measure in the ESRD QIP measure set. We are in the process of determining whether to propose to revise the current Vascular Access Type measures, and/or whether it is feasible to develop and propose to adopt an independent graft measure.”

Measuring hemoglobin levels: Commenters questioned the value of continuing to include a clinical measure to review hemoglobin levels above 12 g/dL due to the payment bundle’s disincentive to over use anemia drugs. One commenter expressed concerns that the low performance standard and benchmark for the hemoglobin greater than 12 g/dL measure places facilities with large numbers of home peritoneal dialysis patients at a disadvantage. The commenter stated that home peritoneal dialysis patients are more likely than in-center hemodialysis patients to have hemoglobin levels greater than 12 g/dL, so facilities with large numbers of home peritoneal dialysis patients are disproportionately likely to have more of their patients with a hemoglobin level greater than 12 g/dL.

CMS response:“We disagree that the apparent difference in average hemoglobin levels for in-center hemodialysis and home peritoneal dialysis patients warrants a revision to the measure specifications for the Hemoglobin Greater Than 12 g/dL measure. First, the FDA-approved labeling for ESAs does not differentiate appropriate hemoglobin levels based on dialysis modality. In addition, we are not aware of evidence-based support for the assertion that it is acceptable for a greater proportion of ESA-treated peritoneal dialysis patients to achieve hemoglobin levels greater than 12 g/dL. For these reasons, we continue to believe that the Hemoglobin Greater Than 12 g/dL measure does not place certain types of facilities at a disadvantage.

In response to a comment suggesting CMS should focus more on identifying cases of hemoglobins less than 10g/dL, CMS wrote:  “Our rationale for removing the Hemoglobin Less Than 10 g/dL measure was published in the CY 2012 ESRD PPS proposed rule (76 FR 40519), and we believe those concerns remain sufficiently valid to merit not reintroducing the measure to the ESRD QIP at this time.