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RPA Comments on the ESRD Quality Incentive Program Proposed Rule

Creation/Revision Date: September 24, 2010

Dr. Donald Berwick, Administrator 
Centers for Medicare and Medicaid Services 
Department of Health and Human Services 
Hubert H. Humphrey Building 
Room 314G 
200 Independence Avenue, SW 
Washington, DC 20201 

Dear Dr. Berwick: 

The Renal Physicians Association (RPA) is the professional organization of nephrologists whose goals are to ensure optimal care under the highest standards of medical practice for patients with renal disease and related disorders. RPA acts as the national representative for physicians engaged in the study and management of patients with renal disease. We are writing to provide comments on selected portions of the End-Stage Renal Disease (ESRD) Quality Incentive Program Proposed Rule. 

RPA appreciates the complexities embedded in the legislative mandate presented to the Agency to establish a quality incentive program (QIP) for Medicare outpatient ESRD providers and facilities. Further, as always we appreciate the Agency’s commitment to its mission of providing appropriate and effective health care coverage to Medicare beneficiaries that promotes cost-efficiency and quality improvement. Our comments focus on the following issues: 

•     Maintaining Budget-Neutrality in the QIP Program 
•     Setting the Maximum First-Year Penalty in the QIP Program at One Percent 
•     Accounting for the Likely Adverse Impact of the QIP Rule on Small Facilities 
•     The QIP Should Explicitly Exclude Patients Not on ESAs from the Anemia Management Measures 
•     Use of 2009 as the Initial Performance Period 
•     Use of a Quarterly System to Reward Prompt Improvement 
•     Adherence to Measure Development Protocols in Selection, Development and Implementation of Future Measures 

Maintaining Budget Neutrality in the QIP Program 

RPA believes that similar to other prospective payment systems and fee schedules in the Medicare program, the QIP program should apply the principle of budget neutrality to the QIP, and keep any savings accrued from QIP within the ESRD system. Accordingly, CMS should reconfigure the QIP into a program that redistributes savings to high performers and facilities demonstrating measurable improvement. 

This change would not only ameliorate the punitive aspects of the proposed 2.0 percent payment adjustment but would also represent further commitment on the part of the Agency to the principles of quality improvement. CMS notes in the proposed rule that the underlying legislation for the QIP, the Medicare Improvements for Patients and Providers Act (MIPPA), generally requires the Secretary to: (1) select measures; (2) establish the performance standards that apply to the individual measures; (3) specify a performance period with respect to a year; (4) develop a methodology for assessing the total performance of each provider and facility based on the performance standards with respect to the measures for a performance period; and (5) apply an appropriate payment reduction to providers and facilities that do not meet or exceed the established total performance score. According to our reading, CMS is not prohibited from reinvesting the savings earned from the QIP program into patient care, we believe that doing so would not only improve care but would also facilitate community buy-in for the program. 

Setting the Maximum First-Year Penalty in the QIP Program at One Percent 

Recognizing that the QIP could serve as a template for future Medicare incentive programs outside of ESRD, RPA joins others in the kidney care community in urging CMS to reduce the payment reduction for the first year to one percent. CMS states in the proposed rule that “the ESRD QIP is the first Medicare program that links any provider or facility payments to performance based on outcomes as assessed through specific quality measures”, and as such it is critically important that the Agency proceed with appropriate deliberation to ensure that the program is as well-functioning as possible. 

The MIPPA legislation states that the “payment consequences of QIP should be up to two percent, thus providing the Agency with the administrative flexibility to implement an adjustment of less than two percent. RPA believes that in the first year, CMS should err on the side of a minimal QIP penalty. This would allow participants to adjust to all of the aspects of the new ESRD PPS and the QIP program before fully implementing the monetary adjustments. We believe that a higher priority should be placed on the creation of an effective and functional system rather than the fiscal difference between a one-and two-percent payment adjustment.

Accounting for the Likely Adverse Impact of the QIP Rule on Small Facilities 

RPA is concerned that the proposed rule does not sufficiently account for the potential impact of the proposed rule on small facilities. While the Regulatory Impact Analysis passage of the proposed rule discusses the impact of the rule on “small entities” the manner in which “small entities” is defined (to include small businesses, nonprofit organizations, and small governmental agencies) would serve to undercount small dialysis facilities (for example, of less than 20 to 25 patients). 

Thus, while the statement in the proposed rule states that “the Secretary has determined that this proposed rule will not have a significant economic impact on a substantial number of small entities”, we believe that there is a clear distinction between small entities as defined and small dialysis facilities, and that small dialysis facilities are disproportionately over-represented within this figure. As a result, the potential for there to be an adverse economic impact on small dialysis providers based on the “small numbers” problem is in fact substantial. 

For an example of how this might impact a small dialysis provider, in a facility with less than 20 patients, if that facility has only one patient with a urea reduction ratio (URR) of less than 65%, that facility will fall below the 96% threshold. Similarly, if that facility has only one patient with a hemoglobin (Hgb) level of less than 10 g/dl), they would not meet the Hgb less than 10 standard. As such, there needs to be some adjustment to demonstrate that a deviation from the performance measure is statistically meaningful. RPA urges CMS to develop a statistically valid methodology for evaluating the performance of small dialysis facilities that does not disproportionately penalize them for the problem of “small numbers.” 

The QIP Should Explicitly Exclude Patients Not on ESAs from the Anemia Management Measures 

RPA recommends that CMS include a statement in the final rule that explicitly states that patients not on Erythropoiesis Stimulating Agents (ESAs) are excluded from the denominator for the QIP measures included in the rule related to anemia management. While RPA recognizes that this issue is addressed elsewhere in federal regulation (such as in the final rule for the ESRD Prospective Payment System), we also feel that it is of sufficient importance and has potential downstream implications significant enough to merit being stated unambiguously. 

Use of 2009 as the Initial Performance Period 

It is RPA’s belief that CMS should use 2009 as the initial performance period. We acknowledge as stated in the proposed rule that providers/facilities are already required to submit all the necessary data needed to calculate the measures as part of their Medicare claims and thus the proposed rule will not create any new requirements. Further, we understand the desire to use data that is as timely as possible in order to most accurately reflect the current state of care delivery in a given facility. 

However, it is our opinion that use of 2010 data in a regulation proposed in July 2010 and not likely to be finalized until late 2010 or early 2011 gives the appearance of being inequitable and inappropriate. RPA therefore urges the Agency to use 2009 as the initial performance period in the QIP. 

Use of a Quarterly System to Reward Prompt Improvement 

RPA believes that CMS should revise the QIP system such that facilities that initially do not achieve the benchmarks are not penalized for an entire year. As an alternative, the QIP process should create an infrastructure that allows for quarterly review of the benchmark data, so that those facilities that promptly improve their performance during the course of the year can be rewarded for that improvement. RPA recommends that CMS develop and implement a system based on quarterly review of performance data that would allow for more frequent performance-based adjustments. 

Adherence to Measure Development Protocols in Selection, Development and Implementation of Future Measures 

As noted above, RPA appreciates the complexity of CMS’ task in developing a system linking payment to performance based on outcomes as assessed by specific quality measures, and we recognize that the Agency’s legislative mandate compels CMS to develop and implement a system on an expeditious timetable. That said, we urge the Agency in the strongest terms possible to adhere to the accepted principles and protocols of measure development science to the greatest degree possible, particularly with regard to future measures. 

In this area, RPA would like to emphasize the following points:  

Future QIP measure development must be open and transparent, and must meaningfully engage nephrologists and other members of the kidney care community;
QIP measures must be evidence based and scientifically sound, with appropriate time and attention devoted to the science of measure development;
QIP measures should include both process and outcomes measures;
QIP measures should be field tested before being used in a pay-for-performance environment; 
CMS should consider measures from sources beyond the Agency’s internal processes; 
Periodic review and appropriate flexibility should be built into the system so that when the science surrounding a particular measure or set of measures changes, the measure(s) can be updated accordingly.
These recommendations specific to future measure selection, development and implementation are offered in a spirit of collaboration and are intended to facilitate the Agency’s fulfillment of its legislative mandate. 

As always, we welcome the opportunity to work collaboratively with CMS in its efforts to improve the quality of care provided to the nation’s ESRD patients, and we stand ready as a resource to CMS in its future endeavors. Any questions or comments regarding this correspondence should be directed to RPA’s Director of Public Policy, Rob Blaser, at 301-468-3515, or by email at


Edward Jones signature 
Edward R. Jones, M.D. 

CC:     Barry Straube, M.D., Director and Chief Medical Officer, CMS 
            Jonathan Blum, Director, CMS Center for Medicare Management 

Renal Physicians Association

1700 Rockville Pike
Suite 220
Rockville, MD 20852

Phone: 301-468-3515
Fax: 301-468-3511

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