500 Medical Park, Suite 100 68639 Bannock Road 1 East Benjamin Drive

Wheeling Dialysis Center Belmont Dialysis at Crestview New Martinsville Dialysis Facility 500 Medical Park, Suite 100 68639 Bannock Road 1 East Benjamin Drive Wheeling, WV 26003 St. Clairsville, OH 43950 New Martinsville, WV 26155 (304) 242-7770 (740) 699-0220 (304) 455-2700 Fax (304)-242-7771 Fax (740) 699-0703 Fax (304) 455-4151

August 30, 2011

Comments regarding 2013-2014 QIP Performance Measures We are pleased to provide CMS with the following comments regarding the proposed changes to the ESRD Quality Incentive Program for PY 2013 and PY 2014; Federal Register (July 8, 2011) http://www.gpo.gov/fdsys/pkg/FR-2011-07-08/pdf/2011-16874.pdf. We support the intent to improve the level of care provided to dialysis patients, and in general, agree with the methodology CMS is using to obtain this result. However, some of the proposed initiatives may have unintended consequences, both for patients and dialysis facilities. There must be a balance between those initiatives that will potentially improve patient care and those that may negatively impact the ability of dialysis providers to achieve specific goals. Furthermore, we are concerned as to whether CROWNweb will be sufficiently functional to collect the data as is intended in the proposed Rule, particularly for PY 2014 implementation purposes. This proposal also includes requirements regarding the use of at least two additional data collection systems, which add time-consuming and costly work for dialysis facility staff. These issues create susbstantial impediments for facility management and clinical staff, who are already over-burdened and increasingly concerned about their ability to meet clinical and financial goals. The additional resulting workload to ESRD Networks must also be considered. Proposed Elimination of Hb < 10 g/dL: The proposal to eliminate the standard of Hb < 10 g/dL, but to continue use of the standard of Hb > 12 g/dL, was undoubtedly developed as a result of recent FDA guidelines, which urge physicians to use lower doses of ESAs to minimize the risk of adverse events. These adverse events may be a result of either high dose ESA or the actual Hb level. Although some dialysis facilities may have not yet changed their anemia management protocols, it is clear that many nephrologists have changed their practice patterns to avoid having patients from (ever) having a Hb > 12 g/dL. However, Hb levels in many patients cannot be easily controlled, and subsequently may exceed 12 g/dL, despite ESA dose reduction long before 1 the Hb reaches 12 g/dL. Many studies have documented the wide fluctuations that occur even with use of rigid dosing protocols. Out of concern for adverse events, but also out of fear of litigation, nephrologists’ practice patterns have changed in recent months, with the result that many patients will have Hb < 10 g/dL. Data has already confirmed that mean Hb levels are falling among dialysis patients receiving ESA. This has also occurred for CKD patients, and it is highly likely that Hb levels in new ESRD patients will also be lower than they have been in recent years. These events will lead to increased use of blood transfusions, hospital admissions for anemia-related problems, and sensitization in transplant candidates, all of which will have serious consequences for patients. The degree to which elimination of the Hb < 10 measure is harmful to patients remains to be determined, but it is unreasonable to expect that nephrologists and dialysis facilities can manage their patients to meet the Hb > 12 goal, and not have an increase in the number of patients whose Hb falls below 10 g/dL. We recommend that CMS: 1. If the decision is made to eliminate the standard of Hb < 10 g/dL, then CMS should support efforts (by facilities, ESRD Networks, and others) to monitor the frequency and cost of adverse events, such as blood transfusion, sensitization, hospital admissions, etc.; 2. develop a methodology to more accurately determine those circumstances that are actionable by dialysis facility staff and nephrologists, since many decisions regarding, transfusions, hospital admissions, etc. are made by non-dialysis physicians. Patient adherence to recommendations regarding dialysis attendance and other factors that may affect Hb levels should also be examined; 3. If the Hb < 10 standard is not continued, then consideration should be given for elimination of the PY 2012 penalties levied for facilities failing to meet the CY 2010 Performance Standard. It is unfair to penalize the dialysis provider for the nephrologists’ appropriate response to the Epogen “black box” warning implemented in 2009. Since physicians’ practice patterns may change quickly due to such regulatory policies, it also would reinforce the need for any QIP to use the most recent available data, and to consider the impact that these and other regulations have on clinical decision-making; 4. develop Performance Score Report (PSR) mechanisms to adjust for unusual patient demographics and dialysis facility census; 5. consider the effect on patient quality of life (QOL) as it relates to anemia management; there is ample evidence that QOL measures are directly correlated with Hb levels, even though CMS and FDA policies appear to disagree with this. One of our dialysis facilities has failed the Hb < 10 measure and URR > 65 measures for the PY 2012 QIP (based upon 2010 data), with a resulting major financial penalty; the Hb > 12 standard was met. In two other facilities managed by our group, all PY 2012 QIP standards were met, which strongly suggests that patient mix in the one facility, as well as, a declining Medicare

2 patient census (2010 as compared to the 2007 census), were responsible for failure, and not practice patterns or protocols. When attempting to review the PY 2012 QIP PSR, we were unable to accurately identify the patients used in the CMS calculations, since no patient identifiers were provided. Even using the designated inclusion criteria (Medicare patients, > 90 days, at least 4 valid claims, etc.), we could not reach the same patient census numbers included in the PSR. We recommend that CMS: 1. Consider providing dialysis facilities with patient identifiers for each eligible patient included in the PSR census; this will assist dialysis providers in reviewing each patient to assure the accuracy of data collection, and in verification that CMS used correct information in performing QIP calculations. 2. This information should also be shared with the respective ESRD Networks, who also experience great difficulty in monitoring and assisting facilities in their performance improvement activities. Additionally, the QIP initiative does not appropriately account for low patient census, unusual treatment setting, or patient case mix. We have submitted detailed comments regarding these issues to CMS as part of a formal PY 2012 ESRD QIP inquiry for one of our facilities that was significantly penalized for failing to meet the 2010 Hb < 10 and URR performance standards. These issues are reiterated in this document as they need to be considered as the QIP initiative moves forward.

The free-standing dialysis facility described above is physically located in a skilled care facility, which recruits many patients from even remote states, since it is the only SNF in this region that can support patients requiring ventilator care and chronic hemodialysis. Located in a rural county, it also serves as the maintenance dialysis facility for ESRD patients who reside in this area. Nevertheless, patient census and acuity fluctuate considerably, resulting in the facility providing care for many patients who require surgical procedures and treatment of medical complications unrelated to ESRD care (see Table below). These and many other factors make it exceedingly difficult for the dialysis staff to manage these complicated patients and meet Medicare ESRD performance goals, which undoubtedly were established considering the typical dialysis facility.

Moreover, this facility has the lowest Medicare ESRD wage index (0.6675) in the continental U.S. The financial burden on this facility due to failure to meet the QIP Performance Measures (based upon an atypical and declining PSR- eligible Medicare patient population), compounded by the extremely low wage index, is large and will jeopardize our ability to continue operating the facility. 3 Comparison of selected comorbid conditions for Dialysis Facility “X” with State average Numbers indicate percentage of patients

CVD PVD COPD Cancer Inability Nursing No. to Home comorbid ambulate conditions

Facility 64.5% 23.5% 41.2% 23.5% 35.3% 22% 4.5

State 25.6% 10.6% 23.8% 8.7% 9.1% 20.3 3.4 (OH)

The simple mathematics facing dialysis facilities with small (and declining PSR) census will cause many such facilities to invariably fail to meet the performance goals, particularly when the census for the baseline measurement period may be substantially larger than for a measurement year. Subsequent financial penalties will make it extremely difficult for small facilities to continue to operate as the QIP initiative moves forward. This is especially the case because of the scoring methods to be used in PY 2013 wherein the facility must score all 30 PSR points; any score below 30 (i.e. 29-26 = 0.5% payment penalty) results in a payment penalty

We recommend that CMS:

4 1. develop a mechanism to adjust for circumstances in which facilities with an unusual care setting, atypical case mix, or small patient census may be at high risk of incurring penalties for failure to meet performance standards; 2. develop a mechanism for regular updating of the patient comorbidity data; use of the CMS Form 2728 may need to be revisited, so that data entry does not become overly cumbersome. At the same time, the current list of patient comorbid conditions for facilities may receive payment adjustment is grossly inadequate and fails to address the most important and commonly-encountered conditions.

Proposed Changes For Payment Year 2014

 Hb > 12 g/dL – We agree with the decision to continue the Hb> 12g/dL standard; with the aforementioned concerns regarding elimination of the Hb < 10 g/dL measure, low census, dialysis facility setting, and atypical patient case mix.

 Elimination of URR as a measure, and to utilize Kt/V in its place - We agree as Kt/V is a more reliable marker for solute removal during dialysis, but it is essential that a uniform methodology for determination of Kt/V be used. Existing equations provide vastly different values, some of which are spuriously higher than results from more robust equations.

1. use the Daugirdas II formula as a standard for all facilities, unless formal urea kinetic modeling or other techniques that provide similar values are used; 2. use standardized Kt/V values as performance standards; using values that have been derived from widely disparate equations would be a flawed approach and should be abandoned. Comparisons for purposes of assessing potential financial penalties must be rigorously validated to assure that if different equations are used, they provide comparable results for Kt/V.

5  Vascular Access Type- We agree that an AVF is the preferred vascular access, and that efforts should focus on reducing the prevalence of catheters, particularly at 90 days.

We have concerns, however, that many factors that determine the ability of a facility to achieve desirable AVF rates are outside the control of the facility and even nephrologists. Specific examples include patients who adamantly refuse to use a “non-catheter” access, surgeon performance, and patients who simply cannot and should not have an AVF, or even an AV graft. Many patients have inadequate blood vessels, advanced atherosclerosis, or body habitus that precludes creating a suitable AVF or AVG. It is unconscionable for nephrologists to “force” patients to have an AVF, when, for example, they have undergone many access procedures, with virtually no chance of having success on the next attempt. This situation is especially important in dialysis facilities that have an unusually large number of patients with peripheral vascular disease, advanced age, and nursing home as place of residence.

Each of our facilities has worked intensely to maximize AVF use and reduce catheter rates, but fluctuating patient census frequently results in falling below goal for these vascular access measures. Loss of even a few established AVF patients to transplant, death, or transfer may result in failure to meet the standard, especially if the eligible Medicare PSR census is lower than that for the baseline period.

We have adopted rigorous procedures for encouraging and monitoring vascular access, to include implementation of a Vascular Access Coordinator position and use of the Vasc-Alert monitoring system. These efforts are costly to the small dialysis provider and are not compensated for under the ESRD PPS. Additionally we have met with local surgeons regularly, but none of these activities can address the types of patients we see nor the overall dialysis facility patient census.

1. consider developing PSR adjusters for unusual patient factors, facility census, and overall case-mix; (all patients and dialysis facilities are not created equal);

6 2. develop a mechanism to more effectively engage, and hold accountable, vascular surgeons in creating successful vascular access; 3. place greater attention on efforts toward catheter > 90 days reduction than AVF rates; 4. consider implementing a ESRD PPS patient adjuster for PVD (peripheral vascular disease) as an acknowledgement of complicated and costly care to promote and monitor vascular access especially in lieu of CMS’ decision to include and individually weight (18%) the Vascular Access Type Measure in the proposed PY 2014 QIP changes (to include potential corresponding payment reductions).

 Vascular Access Infection - This measure has not been endorsed by the National Quality Forum, so its validity as a clinical performance measure has not been widely accepted. Before this measure is used to determine a facility’s eligibility for financial penalty, more work must be done to assure that it meets all criteria as espoused by the NQF.

1. consider changing Vascular Access Infection to a reporting measure rather than a clinical measure for PY 2014.

 Standardized Hospitalization Ratio- We have grave concerns regarding the assumption by CMS that > 90% of admitting diagnoses for ESRD patients are ESRD- related. This is not substantiated by our own experience. Further, since many dialysis patients are admitted by non-dialysis physicians, dialysis facilities and nephrologists frequently have no control over such decisions. We feel that this data needs to be validated before it is implemented.

 Proposed Reporting Measures

7 I. National Healthcare Safety Network Dialysis Events- An important consideration is the additional work burden required by dialysis staff to register and input information. This registry is currently not linked to other required systems, such as CROWNWeb, CAHPS, and certainly not to any facility EMR. The tremendous time and resource outlay is beyond what most dialysis facilities can endure, especially smaller, independent providers.

1. delay implementation of using the NHSN system until it can be fully integrated with other required data-reporting systems

II. In-Center Hemodialysis Consumer Assessment of Healthcare Providers and Systems (CAHPS) Survey - We disagree with the requirement that the CAHPS be the designated instrument for assessing patient satisfaction. This tool, while very detailed, is extremely burdensome to use because of its length and time required for its completion. Further, requiring that an outside facilitator conduct the surveys will be impossible for many dialysis facilities to accommodate. Scoring the assessment is costly, and cannot be justified in the current and likely future environment of decreasing payments for provision of dialysis.

1. abandon the CAHPS as the required tool, and permit the use of alternative patient satisfaction surveys, as determined by the facility

III. Mineral Metabolism- no comments.

8 On behalf of the WRC Mangement Group, I am pleased to offer these comments for your consideration.

Derrick L. Latos, MD, MACP Medical Director