Creation/Revision Date: August 30, 2011
August 30, 2011
Donald Berwick, MD
Centers for Medicare and Medicaid Services
Department of Health and Human Services
Mail Stop C4-26-05
7500 Security Boulevard
Baltimore, MD 21244-1850
Re: CMS-1577-P: Medicare Program; Changes to the End-Stage Renal Disease Prospective Payment System for CY 2012; End-Stage Renal Disease Quality Incentive Program for PY 2013 and 2014; Ambulance Fee Schedule and Durable Medical Equipment; Proposed Rule
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 Proposed Rule for the End-Stage Renal Disease Prospective Payment System (PPS) for CY 2012; End-Stage Renal Disease Quality Incentive Program (QIP) for PY 2013 and 2014.
RPA appreciates the Agency’s efforts in promoting the delivery of high quality care to Medicare beneficiaries with kidney disease. Further, we recognize the complexity of CMS’ charge in balancing the need to promote optimal health outcomes in ESRD patients with exercising its fiduciary responsibilities in the ongoing refinement of the ESRD payment bundle. Our comments will focus on the following issues:
Transparency in Future Refinement of the ESRD Bundle
||Transparency in Future Refinement of the ESRD Bundle
||Retirement of the Lower Hemoglobin Measure in the QIP
||Proposed Payment Reductions for PY 2013/PY 2014 ESRD QIP
||Appropriate Alignment of Performance Standards and Performance Periods
||Impact of QIP on Small Facilities
In previous comments to CMS on the development of the ESRD bundle, RPA has urged the Agency to outline a specific and predetermined process for periodic review of the components of the bundle, with review of the reimbursement for the bundle being required if and when services are added to or removed from the bundle. We continue to believe that CMS should explicitly propose an open and transparent methodology for both determining the components of the bundle and how it will value these components for reimbursement purposes.
Our recommendation is based on the fact that now that the ESRD bundle has become a prospective payment system, it is incumbent upon CMS to ensure that the components of the bundle and their corresponding cost inputs accurately reflect the expenses associated with the resource expenditures necessary to provide the bundle’s services. Accuracy in this area will allow dialysis facilities and other providers of dialysis-related services to appropriately budget and perform operational planning for the services to be provided to their patients in the coming year. Accordingly, an open, transparent, and predictable process for adding or removing components from the ESRD bundle will promote both innovation and cost efficiency in providing dialysis care.
Further, we concur with the comments of Kidney Care Partners (KCP) and other stakeholder organizations that CMS should utilize the standard proposed rule/final rule, notice and comment rulemaking process for refining the components and attendant costs of the ESRD bundle. The Agency will already be developing and proposing a revised ESRD prospective payment system annually, and RPA believes that using the PPS process for refining the components and costs of the bundle will be both operationally efficient and responsive to the recommendations of the kidney community.
Retirement of the Lower Hemoglobin Measure in the QIP
RPA recommends that CMS should explicitly propose an open and transparent methodology for both determining the components of the bundle and how it will value these components for reimbursement purposes, and that the established notice and comment rulemaking process is an appropriate vehicle for this process.
As noted in numerous previous communications with CMS and other federal agencies regarding the use of Erythropoiesis Stimulating Agents (ESAs) for treatment of anemia in adults with CKD, RPA shares the safety concerns associated with ESA prescriptions that result in high hemoglobin (Hb) levels or very high ESA doses. We recognize that recent studies have raised substantial concern about the safety of ESAs when they are used to raise Hb concentrations to the normal or near normal range of Hb greater than 13 grams per deciliter (Gm/dL). In a recent letter to the Food and Drug Administration in response to their recent label change affecting ESAs, RPA expressed our appreciation for FDA’s recognition of the importance of physician-patient relationships and the need to individualize treatments, considering the benefits and risk of ESAs.
Nevertheless, we firmly believe that CMS’ decision to retire the lower hemoglobin measure as part of the ESRD QIP poses serious patient safety risks to a significant percentage of the Medicare ESRD beneficiary population. While safety risks have been identified from studies when Hb targets of 13 g/dL or higher have been used, the same is definitively untrue for Hb targets above 11 g/dL. At the 11 g/dL range there can be a reasonable balancing of benefit against potential risk, particularly in hemodialysis patients. There are no studies indicating safety risks for patients being treated at intermediate targets, such as 11-12 gm/dl. While RPA does share concerns about cardiovascular safety risks for patients treated to high Hb levels or using very high ESA doses, we have consistently recommended to policymakers to consider the needs of severely anemic patients at low Hb levels. As such, we believe that concerns about higher levels of hemoglobin and ESA doses may lead to the unintended consequence of under-dosing, and inducing severe anemia.
Indeed, it is our belief that as a result of other policy changes affecting ESA use, most nephrologists have already been reducing doses for ESAs at or around Hb 11 g/dL, which would address the thrust of the FDA labeling to minimize the risks shown at higher Hb levels. RPA is now concerned that the retirement of the lower hemoglobin measure in the QIP will cause the policy pendulum to swing too far in the opposite direction, with potential harm of causing persistent, severe, or transfusion-dependent anemia in patients at lower hemoglobin levels. This policy change may unnecessarily create a separate patient safety issue for patients with lower hemoglobin levels, with precipitous drops in individual patients’ hemoglobin levels and thus adversely affecting patients not demonstrated to be at risk.
RPA believes that other adverse consequences from the retirement of the lower hemoglobin measure will occur as well. It is our belief that the new policies specifically directing nephrology practitioners to initiate treatment when the hemoglobin level is less than 10 g/dL and reduce or interrupt the dose if the hemoglobin level approaches or exceeds 11 g/dL for dialysis patients, and 10 g/dL for non-dialysis CKD patents will leave little room for clinical judgment. We as noted appreciate the FDA’s recognition of the importance of physician-patient relationships and the need to individualize treatments; this decision seems to run counter to those concepts. Finally, it is our opinion that retirement of the lower hemoglobin measure will have a chilling effect on the ability to pursue innovation in the treatment of patients with CKD.
Proposed Payment Reductions for PY 2013/PY 2014 ESRD QIP
RPA recommends that CMS should reverse its decision to retire the lower hemoglobin measure to avoid unnecessarily creating a separate patient safety issue for patients with lower hemoglobin levels, as well as for the other compelling reasons noted above.
In the rule, CMS proposes to implement a more rigorous sliding scale of payment reductions for the PY 2013 ESRD QIP by raising the minimum total performance score that providers/ facilities would need to achieve in order to avoid a payment reduction from 26 to 30 points (out of 30 points). Thus, dialysis facilities would need to achieve a perfect score in order to avoid a payment reduction. The proposed rule also compresses the payment reduction scale from five possible results included in the PY 2012 reduction scale to four, eliminating the 0.5% reduction, and goes on to infer that for PY 2014 facilities would have to achieve a perfect score of 60 out of 60 to avoid a payment penalty for that payment year.
RPA believes that this series of policy changes are unreasonable and in effect will represent an automatic 1.0% payment reduction for the vast majority of providers and dialysis facilities. The multitude of factors affecting both the clinical variability of dialysis patient presentation and the delivery of on-site dialysis patient care will contribute to the likelihood that even the finest dialysis facilities may not always be able to achieve a perfect score. To impose what seems to be an inevitable payment penalty on these dialysis facilities and providers is beyond the rule of reason.
Appropriate Alignment of Performance Standards and Performance Periods
RPA recommends that CMS maintain the PY 2012 payment reduction scale for PY 2013 and PY 2014.
In the Proposed Rule, the Agency indicates that it will use 2007 and 2009 data to establish the Performance Standards and use 2011 as the Performance Period for QIP implementation in PY 2013. While RPA recognizes the difficulty in developing a prospective, incentive-based performance improvement initiative, a configuration of this nature that uses out-of-date data in a performance year that is already passed by the time the dialysis facilities and providers are implementing the program seems destined to invite problems.
Alternatively, RPA would recommend that CMS establish 2012 as the performance year for PY 2013, using data from 2011. This alignment would allow dialysis facilities and providers gauge to their performance using clinically relevant data that is far timelier than that proposed by the Agency. Further, it would have the added benefit to CMS of being much more prospective than that originally proposed, and thus more greatly aligned with the Medicare Improvements to Patients and Providers Act (MIPPA) mandate for a prospective quality incentive program.
Impact of QIP on Small Facilities
RPA recommends that CMS establish 2012 as the performance year for PY 2013, using data from 2011.
RPA continues to believe that CMS has not sufficiently addressed the issues that the QIP presents for small dialysis facilities/providers. In the proposed rule, the Agency includes the following language:
Consistent with the PY 2012 ESRD, we are also proposing to require providers/facilities to have at least 11 cases that meet the reporting criteria for a measure in order to be scored on the measure. As we noted in the 2012 ESRD QIP final rule, we believe that this minimum case threshold will help prevent the possibility that a small number of poor outcomes artificially, and for reasons unrelated to the quality of care, skews a small provider/facility’s performance score. Additionally, eleven cases is a statistically valid threshold that will give us confidence that a provider or facility’s total performance score is an accurate reflection of the quality of care it furnishes.
RPA does not agree that eleven cases is a statistically valid threshold. If the threshold were to remain at eleven, it is our strong belief that small dialysis providers, many in underserved and/or rural communities, would be inappropriately penalized due to the tyranny of small numbers, and that their ability to remain open and care for their patients would be compromised. Thus, the macro-level impact of an eleven-case threshold in the QIP is that Medicare beneficiaries with ESRD would be poorly served. RPA concurs with KCP that the statistical validity of the QIP as it affects small providers would be strengthened if the minimum threshold were increased to twenty cases.
RPA recommends that CMS increase the minimum threshold for providers/facilities to be included in the QIP from eleven cases to twenty cases.
As always, RPA welcomes the opportunity to work collaboratively with CMS in its efforts to improve the quality of care provided to the nation’s kidney 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 firstname.lastname@example.org
Ruben L. Velez, MD