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We reviewed submitted comments to CMS, which were due to the agency by Aug. 31, from a number of patient and professional organizations. The full comments are available here, and more comments will be posted at the NN&I website as they are received.
Be sure to register for NN&I's webinar on the QIP, schedulated for Oct. 23. Click here to register.
Comments varied by organization, depending on whether they were focused on change to the composite rate or more on the QIP measures. Kidney Care Partners and the National Renal Administrators Association focused on the bundled payment rate. Most of their comments were directed at how the payment rate system was structured and how it was being evaluated by CMS. The NRAA expressed specific concern about how ineffective the case-mix adjustors were, and how smaller dialysis clinics would struggle to meet forthcoming reporting requirements for QIP measures.
American Nephrology Nurses Association president Glenda Payne focused on several points in her letter to CMS, in particular the need to develop quality measures that can be linked to outcomes. "As CMS works to update and refine the QIP program, ANNA urges the agency to focus its efforts on the adoption of quality measures that truly affect patient survival and quality of life. Each QIP measure should be carefully chosen to ensure the measure is validated, and has a direct effect on patient outcomes. Simply having an NQF-approved measure does not mean it should be included in the QIP program. Each added QIP measure consumes resources, and potentially negatively impacts critical aspects of care as facility staff are pressured to try to improve each QIP measure in order to avoid payment penalties."
ANNA also urged CMS to support work to develop a QIP measure for fluid management. "Failure to successfully manage fluid volume is recognized as a major factor in hospitalizations, rehospitalizations, and mortality in the dialysis population," Payne wrote.
While the nursing organization thought fluid management was an important quality measure, they weren’t as enthusiastic as the newly proposed one on hypercalcemia. "ANNA does not support the adoption of a clinical measure for hypercalcemia. While it is clear that disturbances in bone and mineral metabolism are associated with adverse cardiovascular (CV) outcomes and mortality, a more complete measure of this risk would include the additional monitoring of phosphorous and intact parathyroid hormone (iPTH) levels. This comprehensive approach is consistent with the clinical practice guidelines for the Diagnosis, Evaluation, Prevention, and Treatment of Chronic Kidney Disease – Mineral and Bone Disorder (CKDMBD) developed by the Kidney Disease Improving Global Outcomes (KDIGO) initiative," Payne wrote.
Kidney Care Partners
While CMS concluded recently that the new bundled payment system has not affected access to care or the level of quality, Kidney Care Partners wrote in its comments on the proposed rule that a lack of a rate-setting file limits providers’ ability to provide comprehensive and meaningful comments. "As we have previously noted, without the rate-setting file, stakeholders cannot analyze fully the impact of the proposed rule because of limited available data. The Agency should provide for greater transparency in the rulemaking process by providing a rate-setting file, as it does for other Medicare providers."
KCP also reiterated past comments on proposed PPS rules that documentation requirements of the comorbidity case-mix adjustors, the need to modernize the ESRD cost report, and technical concerns related to the establishment of the base rate should be addressed by the agency. "Specifically, we also recommend that CMS recalculate the standardization factor using 2011 data, similar to its recalculation of the outlier parameters and the correction to the transition adjustment; suspend the use of the comorbidity case-mix adjustors unless or until the Agency provides dialysis facilities and providers with information necessary to document these adjustors; protect the integrity of the ESRD PPS bundle by gathering the true cost of providing dialysis items and services through the cost report; provide a clear process for expanding the bundle and incentivizing new technology; address technical calculations related to the base rate; and recognize the impact the bad debt changes will have on Medicare margins."
Lastly, KCP expressed some concern about how CMS plans to incorporate oral-only drugs into the ESRD bundle in 2014 to "allow for a transparent and cooperative process with the kidney care community."
Forum of ESRD Networks
In its comments on the proposed rule, the Forum of ESRD Networks supported language in the QIP for 2015 that includes a validation process of the QIP data from a sampling of clinics. Also: "In our comments last year, we encouraged the use of methodologies that recognized changes in performance over time and advocated the use of the most recently available data as comparison data.
Under comments about use of clinical measures, such as anemia and adequacy, the Forum urged CMS to watch carefully the impact of losing the hemoglobin ‘floor’ and the potential increase in blood transfusions; it also recommended that residual renal function should be considered in the reporting of the Kt/V for hemodialysis (both in-center hemodialysis and home hemodialysis) as it has been for peritoneal dialysis, when CMS drops the URR clinical indicator for 2015. "We are concerned that unless residual renal function is included in hemodialysis dose calculations, patients with significant residual renal function may be coerced into unnecessary prescription or modality changes because of the misperception, based on measurement of delivered Kt/V alone, that their total clearance is insufficient. Patients with the cardiorenal syndrome may be particularly disadvantaged."
National Renal Administrators Association
In its comments about the composite rate, the NRAA complained -- as have dialysis providers in the past -- about the inability to receive payment for co-morbidity adjusters because of the lack of available data. "NRAA questions whether providers are able to actually claim the adjustments estimated by CMS," wrote NRAA president Sue Rottura. "Many providers, particularly the SDOs and MDOs, are having great challenges getting the necessary data needed for the payment adjustments. As a result, we are concerned that facilities are not receiving the payments intended by the PPS and would prefer fewer adjustments and a higher base rate."
While the NRAA supports language in the proposed rule to eliminate the restriction on Daptomycin and to allow ESRD facilities to receive separate payment by placing the AY modifier (allows Medicare to pay for items or service furnished to an ESRD patient that is not for the treatment of ESRD) on the claim form for this drug, the association is "very concerned" about the proposal to exclude thrombolytic drugs from separate payment under the composite rate portion of the blended payment during the transition. "We respectfully disagree with the agency that heparin can be used as a substitute for alteplase. NRAA views these drugs as being used for separate purposes in a dialysis facility. Heparin is used to prevent clotting whereas alteplase is used to avoid a more costly procedure – replacement of a non-functioning or poorly functioning catheter. This change in policy will be a problem for facilities that chose to transition to the bundled payment system."
In comments about the proposed performance and reporting measures for 2015, the NRAA said it supports the proposal to expand the NHSN Dialysis Event reporting period to 12 months, but feels that the 98% compliance rate for gathering patient data for the Expanded Mineral Metabolism Reporting Measure is too high. "If small units are unable to get results from even one or two patients during the month, such as if the patient is traveling, the threshold will be missed. This requirement will also have an adverse impact on patients, making it more difficult to travel because of the facilities’ need to attest that it is monitoring their calcium and phosphorous levels on a monthly basis. The NRAA suggests that CMS limit reporting on these measures to patients who have received seven or more treatments per month." The Association expressed the same concerns for the Anemia Management Reporting Measure and suggested the same seven-treatment threshold.
The NRAA suggested delaying use of the Kt/V Dialysis Adequacy Measures until PY 2016. "The proposal to use Kt/V values reported on CY 2011 claims may not produce reliable data to establish the standards as there may be variations in the data from facilities that reported Kt/V voluntary compared to the facilities that did not report." Similar to ANNA, the NRAA suggested CMS defer the implementation of the hypercalcemia measure for one year, saying data should be collected to establish a baseline for measurement. "The data that exists on this measure comes from CROWNWeb which is largely comprised of data from the large dialysis organizations (LDOs). Additionally, we are concerned that this proposed measure is not consistent with industry standards for clinical practice."
Overall, the NRAA called the proposed performance standards for 2015 "too rigid," and that CMS is "expecting perfection. This circumstance is especially troublesome for the smaller facilities as one or two patients can cause these facilities to miss the performance thresholds. Dialysis facilities have little control over how patients will respond or adhere to treatment. Moreover, the performance standards do not take into account improvements in patient health. Even if a severely ill patient improves in health, the facility will still be penalized if his or her overall health remains below the performance standards."
Patient advocacy groups
Home dialysis reimbursement
Most patient organizations expressed disappointment with the current Home Hemodialysis reimbursement rate. Home Dialyzers United noted that the current $36 provided per session only covers one hour of a nurses time, while they estimate nurses spend an average of four hours per day over the training period.
Organizations also expressed concern over the potential for disparities in access to home dialysis care. Home Dialyzers United said they heard of patients with commercial insurance receiving preferential access to home dialysis and said they do not believe all patients are being evaluated for home dialysis, as the Conditions for Coverage requires. The National Kidney Foundation said they are concerned about providers cherry picking patients, and believe CMS should monitor providers for this.
Hrant Jamgochian, JD, LLM, executive director of Dialysis Patient Citizens, wrote that the QIP should be rewarding providers for high quality care: "The name alone – Quality Incentive Program – emphasizes Congress' objective to reward providers for improving care. Therefore, DPC is concerned that CMS has interpreted the program to only act as a penalty for those providers who fail to meet the quality standards. DPC strongly urges CMS to establish a means to also reward those providers who deliver the highest quality of care."
But Home Dialyzers United said the QIP penalties may have become too watered down because of the growing number of measures increasing while the 2% maximum penalty remains the same: "The QIP should not be easy for providers to attain," wrote Richard Berkowitz, president and founder of HDU, and Denise Eilers, chairperson of public advocacy for the group. "Instead, it should be a constant challenge in order to provide an ever increasing quality of care. We should never be satisfied with the status quo. We appreciate the fact that CMS wants to add more measures to the QIP. However, as long as Congress mandates a 2% withhold, we feel the more measures added dilutes the 2% withhold to the point that it effectively makes the QIP counterproductive."
Most patient organizations have concern over vascular access measures, which they say should also take into account that not all patients are good candidates for fistulas: "Many observational studies have shown that the elderly are less likely to have a successful AV fistula created and ultimately mature to support hemodialysis treatment," wrote Joseph Vassalotti, MD, chief medical officer of the National Kidney Foundation. "In addition, there are concerns in the nephrology community that the Fistula First Breakthrough Initiative is over-emphasizing the necessity for an AV fistula. As such, measures that focus on catheter limitation are important to emphasize, since these consider limitation of the access that is associated with the most adverse outcomes."
Lori Hartwell, president and founder of Renal Support Network, wrote: "CMS should continue to encourage and track the percentage of AV fistula use, but modify the QIP metric to encourage the use of fistulas first, grafts second, and catheters last."
The four organizations also said they support the AY modifier, which allows Medicare to pay dialysis facilities for items or service furnished to an ESRD patient that is not for the treatment of ESRD and fear CMS is considering eliminating it because of misuse. "We are troubled with the assertion that there may be abuse of this tool, but also concerned that CMS [has] provided little data on the exact abuses or the scope of the problem," the DPC letter said.
The organizations also provided survey options and suggestions for the proposed Patient Experience of Care Survey Usage Measure and asked for tools to measure parathyroid hormones and phosphorous levels. Some organizations expressed support for Kt/V as a measurement of dialysis adequacy over URR, but many also noted the limitations of the measurement with home and pediatric patients. HDU said they believe the industry should be moving away from the concept of adequate care and instead focus on optimal care. RSN said they accept Kt/V as a measurement "until a more accurate measure of whether dialysis cleanses the blood effectively is developed and adopted by the community."