The comment period for the 2012 End-Stage Renal Disease Prospective Payment System and the ESRD Quality Incentive Program is over and the renal community has weighed in on the issues.

Many have asked for an update to the home dialysis hemodialysis and home peritoneal dialysis training add-on, saying there is not enough financial incentive for centers to start new home dialysis programs.Some organizations are concerned about the effect some of the payment changes will have on small dialysis organizations.

The most commented on issue in the Quality Incentive Program has been the proposal to eliminate the minimum hemoglobin level from the ESRD Quality Incentive Program. Patients and advocates have consistently expressed fear that the proposal might lead to lower hgb levels, diminished quality of life, a higher rate of blood transfusions, and ultimately less working kidney patients and eligible transplant recipients. Some providers and organizations support the proposal, but recommend CMS monitor its effect on patients .

Below are some of the submitted comments from advocates and kidney organizations. All of the submitted comments can be accessed here.

"Bundling has already negatively impacted patients. Some of the fears brought up before the rules were finalized have come to fruition. Providers have in a large part changed the medications prescribed to the detriment of patients. Many patients are suffering because changing practices of providing analog vitamin D and iron, among others. It appears new innovations are slowing. New products coming to the market which provide greater patient safety are finding it difficult to crack the doors open when providers are trying to cut pennies from their cost structure. Welcome penny wise and pound foolish to dialysis.

Read NxStageUsers' comments  

 

"Neither the new ESRD payment system nor the proposed 2013 QIP would hold ESRD providers accountable for the adverse clinical outcomes of under-treatment of anemia, including blood transfusions and hospital admissions ... In addition, under the new payment system, ESRD providers are paid separately for furnishing blood and blood products, which could create an incentive for some providers to treat anemia with blood transfusions."

Read the Medicare Payment Advisory Commission's comments 

 

"The final rule for the implementation of the ESRD PPS indicates that there will not be a wage index floor after the transition period to the new payment system is complete.  We believe this policy is detrimental to SDOs.  Some of the country’s small facilities are located in a single community.  As such, they are not able to spread their operating costs over multiple geographic areas as can larger organizations.  For those facilities that are in parts of the country where the wage index is lowest, the absence of a floor threatens their survival and negatively affects their patients’ access to care.  These facilities fulfill a vital need, by providing access to patients who may otherwise have to travel extraordinary distances to be dialyzed."

Read the National Renal Administrators Association's comments  
  

NKC understands that the hemoglobin less than 10 g/dL measure may not be an appropriate payment measure within the QIP at the current time given the June 2011 FDA Black Box Warning culminating in a label change for ESAs, removing the target range of 10-12 g/dL. Reluctantly w agree with CMS' proposal to eliminate use of this measure for QIP in 2013 and 2014. However, we believe it is important for CMS and the kidney care community to monitor changes in upper and lower hemoglobin of patients to promote optimal care. This is a critical and potentially dangerous time for dialysis patient care in our country.

Read the Northwest Kidney Centers' comments 

 

"In the Proposed Rule to establish the PY 2013 QIP, CMS proposes to retire the anemia management measure---Hemoglobin Less Than 10 g/dL. DaVita strongly supports this proposal but believes that its legal and policy rationales apply to the PY 2012 QIP as well."

Read DaVita Inc.'s comments 

 

"The new bundled payment system coupled with the recent FDA label change is already exerting downward pressure on hemoglobin levels in dialysis patients.  Recent data from the DOPPS Practice Monitor is already showing a decline in hemoglobin levels, particularly in African American patients.  The data shows a greater rise in the percentage of patients with hemoglobin levels less than 10 g/dL and a larger decline in mean hemoglobin levels in African American patients compared to other hemodialysis patients.  The report calls for additional monitoring of these trends and evaluation of their potential consequences.  Clinical data has demonstrated an increased association between hemoglobin less than 10 g/dL and increased transfusions and morbidity.  Because of this critical patient safety issue, DPC supports timely reporting of hemoglobin below 10 g/dL. "

Read Dialysis Patient Citizens' comments
 

While hemoglobin less than 10 is not included as a pay metric at the current time, this lower level standard is still very important to patient safety.  Therefore, CMS should continue to collect the Hg < 10 g/dL data as it currently does through the claims and make such data available through Dialysis Facility Compare (DFC) on a current basis to patients and the public.  Furthermore, CMS should work with the American Kidney Fund and others in the kidney care community to determine the feasibility of including hemoglobin less than 10 g/dL as the lower level measure for reporting under the QIP. Finally, AKF also strongly encourages that as soon as possible, an appropriate clinically relevant lower hemoglobin measure should be included in the QIP for payment.

Read the American Kidney Fund's comments
 

 

"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."

Read Wheeling Renal Care's comments

 

"The elimination of the hemoglobin level below 10 g/dL quality measure may result in lower hemoglobin values of dialysis patients with a resulting increase in patient symptoms of weakness, fatigue, and general decline in overall sense of well being ... It may also negatively impact a patient's ability to choose a more palatable and meaningful choice of modality, such as home therapy, due to lack of energy, a decline in cognitive function, and weakness."

Read the American Nephrology Nurses' Association comments 

 

"The dialysis community is still digesting the changes that have come with the bundle. The data I have seen through DOPPS and the reports I have heard through email and online communities, is that ESA use has declined since the final rule was announced a year ago. And that this has resulted in generally lower hemoglobins, which the affected dialyzors report limits their energy and thus diminishes their quality of life."

Read Bill Peckham's comments

 

"The invention and use of ESA’s saved the lives of hundreds of thousands of patients including mine. It has given me the ability to successfully live with this disease because it is a part of my health care team’s overall medical treatment approach to stabilizing my disease. When hemoglobin is kept within the recommended 10-12 g/dl target range the patient’s anemia stabilizes to a point where they feel better and have the energy to start the long road back to rebuilding a stable and successful life with kidney disease."

Read Shad Ireland's comments

 

"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."

Read the Renal Physicians Association's comments

 

"Abbott is concerned that CMS does not specifically address monitoring or measurement of parathyroid hormone(PTH) All three BMM components---calcium posphorous, and PTH---are equally important to the assessment and determination of BMM treatment ... This is especially critical to safeguard care for vulnerable patient populations."

Read Abbott's comments
 

 

"Given our current environment, it is necessary to minimize dosing of ESAs. Having no minimum standards for anemia management will drive down hemoglobin levels to the point patients will become weak and fatigued, require blood transfusions, have increased hospitalizations, and may request early retirement or disability. While the economic strain on dialysis providers should promote comparative effectiveness and the selection of a least costly alternative to care, minimal standards for all to abide by must remain in place as a safeguard to patients, and to assure that their quality of life is not interrupted."

 

Read the American Association of Kidney Patients' comments

 

 

"In order to maintain and facilitate beneficiary access to all modalities of kidney replacement therapy, CMS should update the home hemodialysis and  home peritoneal dialysis training add-on so as to keep pace with increasing costs, such as nursing salaries, that facilities and providers incur to provide these services."

Read the National Kidney Foundation's comments