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

Re:     CMS-3206-P: Medicare Program; End-Stage Renal Disease Quality Incentive Program Proposed Rule

Dear Dr. Berwick,

Dialysis Patient Citizens (DPC) is pleased to provide comments on the Proposed Rule for the End-Stage Renal Disease Quality Incentive Program (QIP). As America’s largest dialysis patient organization, DPC is proud to represent over 22,000 pre-dialysis and dialysis patients and their families.  We seek to ensure that the patient’s point of view is heard and considered by policy makers on a wide variety of issues so continued progress may be made in the quality of care and life for all dialysis patients. 

DPC’s mission is to improve the quality of life of dialysis patients; we accomplish this by promoting favorable public policy and patient education. However, improving quality of life for patients can only go so far without improving the quality of care patients receive.  DPC knows that a diagnosis of End-Stage Renal Disease (ESRD) does not mean the end of life. Dialysis patients can lead long, productive lives; mostly because of Congress’s and Medicare’s commitments to ensuring patients have access to quality kidney care.  It is for these reasons that we respectfully submit comments on the latest evolution in Medicare’s quality improvement strategy for dialysis patients.  Our comments are based on the following core values we believe are important to implementing a program that will truly improve the quality of care patients receive and thus the quality of lives they lead.

DPC Core Principles for guiding the QIP

1. Promote incentives for all dialysis facilities to deliver optimal care to all patients.

a. As the QIP grows, incentives need to be robust enough to encourage facilities to provide care that results in the best outcomes for patients instead of incentivizing facilities to achieve minimalist standards to maximize dollars.

b. The QIP should include measures relevant to evaluating quality care for home dialysis patients.

c. The QIP should be devised in such a way that even the smallest facilities are held to established quality standards.

2. Reward for improvement and do not further remove dollars from the ESRD payment system.

a. Since the QIP reduces payment for underperformance the program is likely to generate some savings to Medicare.  DPC believes CMS should reinvest these saved dollars back into the ESRD Medicare program.

b. While the Medicare Improvement for Patients and Providers Act (MIPPA) seeks a cut in reimbursement for facilities that do not achieve quality standards there is no reason dollars saved from this strategy could not be used to reward top performers and improvers.  This could further incentivize facilities to improve quality beyond benchmarks.

3. Encourage continuous improvement from all facilities.

a. There are likely to be facilities that are lower than average performers, but rather than continuously penalize these facilities for not achieving national standards immediately the QIP should incentivize these facilities to achieve improvements in quality.  Failing to incentivize these underperforming facilities to improve could lead to significant access to care problems for patients.

4. Implement proven outcome measures.

a. The ESRD QIP is a pioneer program that will, for the first time, align Medicare payment with improvement in patient outcomes.  We ask that CMS continue to work with nephrologists and experts in kidney care to implement measures into the QIP that assess the impact the delivery of care has on patients’ outcomes.

5. Improve disparities in outcomes.

a. A sound QIP should improve upon regional and racial disparities in outcomes.

6. Accurately and in a timely manner provide consumers and physicians with information on the quality of care each dialysis facility provides.

a. Patients need to have access to timely information related to the quality of care a facility provides in order to make informed decisions about their care.  Since most patients choose a facility based on their physician’s referral, it is important for physicians to believe in the credibility of the quality scores so they will use this information when referring patients to a facility.

With these core values in mind, we respectfully submit comments to the structure of the proposed QIP on the areas below:

Initial year of the QIP

• Baseline Year
  

While we respect and understand CMS’s current challenge in utilizing more timely data, we believe using the 2007 facility based performance measure and the 2008 national average does not appropriately reflect current quality because it does not take into account any changes in practice that may have occurred after these years.  Instead, we believe CMS should use more current data and we suggest using 2009 as the baseline for both the facility based measure and the national average. Using a more current timeframe  to establish the initial baseline will improve the credibility of the data reported and make it more likely that beneficiaries and physicians will use this information to make decisions as to where patients can receive the best care.

• Performance Standard Year
  

Since the QIP reductions will not take place until 2012 we believe facilities should be judged on the quality of care they deliver in the preceding year.  Additionally, using 2011 as the initial performance standard year measured against 2009 as the benchmark will hold facilities to quality standards established prior to a bundled payment system in the year many facilities are likely to begin receiving payment under the new prospective payment system.  Establishing 2011 as the performance standard year will also provide CMS with valuable information as to how well facilities are able to maintain or improve quality under a new payment system when compared to 2009.

• Points scale
  

While the points system is a straight forward approach we are concerned that it does not take into account smaller sized facilities whose quality score could be thrown off by just one patient that has difficulties meeting quality measures.  We believe optimal care should be provided to all patients and that caregivers should continuously innovate and work hard to ensure a patient achieves desired outcomes. However, we also recognize that outcome based measures are not all about the care delivered, but are also about the individual patients’ compliance and other health conditions.  Therefore, CMS needs to establish a system that takes into account the unique challenges facing small facilities, but also ensures these facilities are held to appropriate quality standards.  We encourage CMS to re-evaluate and work with the kidney care community to define small facilities and ensure they are incorporated in the QIP fairly.

• Weighting of Measures
  

DPC is pleased with CMS’s proposal to weight the hemoglobin measure of below 10g/dl more than the above 12g/dl.  As we conveyed in our comment letter on the ESRD PPS, we believe the bundled payment already provides a disincentive for using ESAs to achieve hemoglobin levels greater than 12g/dl and therefore stated a measure for above 12g/dl was not necessary. However, we view the extra weight on 10g/dl as a reasonable compromise.

Additionally, we would like to clarify that we believe the below 10g/dl measure should be collected for all patients, not just those who have ESAs listed on their claims forms.  A hemoglobin level below 10g/dl indicates anemia and should be treated. 

The QIP should incentivize facilities to provide appropriate anemia management treatment to all patients who are anemic. 

Conversely, if a patient can maintain their hemoglobin above 12g/dl without ESA therapy then we do not believe facilities should be penalized for those patients.  Therefore, we recommend the QIP measure hemoglobin above 12g/dl for patients who receive ESAs as CMS has proposed.

• Maximum payment reduction
  

DPC is concerned about access to care issues that could ensue following the initial year of the QIP if a maximum penalty of 2.0% is imposed on underperforming facilities.  Since an incentive program that cuts payment rather than rewards with additional payment is new to CMS and to the kidney care community, we recommend that CMS use 1% as the maximum penalty in the initial year. With so many unknown factors and no ability to test a revolutionary quality program, rather than risk substantial underpayment to a facility that is already struggling to treat patients under a new payment system, we believe it is more prudent to limit quality payment reductions to just 1% in the initial year in order to assess its impact. 

We recognize the risk in doing this is that a lower payment reduction is less of an incentive to meet quality benchmarks; however we have to balance our concern of facilities restricting care due to tight resources with facilities struggling to continue to provide care with limited resources.

• Beneficiaries coinsurance calculation
  

We agree with CMS’s recommendation to calculate beneficiaries’ coinsurance after applicable quality payment reductions have been made.  Beneficiaries should not pay more than 20% of what CMS pays facilities and should certainly receive some financial savings if their facility is not performing up to quality standards.

• Public Reporting
  

While we believe Dialysis Facility Compare (DFC) is underutilized by patients, we do believe that continuity in quality reporting should be maintained and therefore DFC is likely the best platform for web reporting.  Wherever CMS reports quality we believe consistency in its reporting is the most important decision CMS can make in public reporting.  Patients need to be able to see the same quality information indicated on the certificates as is on the website. This will ensure patients receive a clear picture of the quality score facilities receive.  If CMS is to continue to post other indicators of quality that are not part of the QIP then it should be clear to users that those measures are not part of the facility’s “score”.

We also agree the certificates should contain only QIP measures and be succinct in order to draw patients’ attention to the scores and create clarity.  Recording the score as a number out of a total will help provide clarity on how the facility ranks in terms of points.  For example, a facility receiving a total score of 21 should be shown be reflected on the certificate 21 out of 30. The same should be used for each individual measure.  To show a comparison CMS could list also display the national average score.  The web address where patients can go to learn more about their facilities’ scores should be listed on the certificate.

We envision DFC to be one source for consumers to seek elaboration and further clarity on the QIP scores.  However, as many patients still do not utilize the web we believe CMS should also communicate the QIP to all beneficiaries in written form.  All written communication on the website, certificate and in mailing materials should be targeted to a 6th grade reading level to ease understandability by the majority of patients. 

In order to ensure patients are aware of the quality program, a greater communication effort needs to take place.  As a patient advocacy organization DPC will work to ensure dialysis patients are aware of the quality program and have the means and ability to find out more about the scores and how their facilities rate.  However, CMS should also put together a communications plan to educate beneficiaries on the quality score.  One potential way is to launch a QIP campaign and have the ESRD Networks administrate it.  DPC is happy to continue working with CMS to support communication efforts about the QIP.

Future years of the QIP

• Program Monitoring and Evaluation
  

In addition to quality measurement, we agree CMS should utilize the data available to them to monitor trends in medication use, treatments, access to care, mortality, demographics, etc. as a way to evaluate how the new PPS and QIP are changing patient care.  This was something we advocated for in our ESRD PPS comment letter on December 15, 2009 and believe is necessary in order to ensure the overall quality of care does not decline.  This information should also be made available to the public, but distinct from QIP scores.  Additionally, we believe monitoring efforts should also include a dialogue with beneficiaries about their perspective on the care they have received.  This monitoring can provide CMS and Congress with valuable information to help make any necessary adjustments and improvements to the ESRD PPS and/or QIP.

• Encouraging Improvement
  

We agree with CMS that future years of the QIP should encourage continuous improvement and not allow for facilities to receive full payment if they fall below their previous year’s performance.  However, we continue to caution that improvement needs to be attainable for all facilities in order to maintain patient access to care.  We believe the best way to maintain access to care and encourage improvement is to reinvest dollars saved from the QIP payment reductions and provide the facilities that show the greatest improvement and deliver the highest quality of care with reward payments.

• Future Measures
  

While we seek for the QIP to be robust and comprehensive in future years, we believe these measures should continue to be based on outcomes that translate into improvements in overall health and quality of life of patients.  These measures should be consensus based and allow for input to be provided by the kidney care community, including patients.  CMS needs to strike the right balance with its measures in the QIP to allow it to be comprehensive, but to also ensure the measures are targeted and will improve the quality of care beyond what it is today.

Implementing too many measures into this penalty based system could essentially water down the impact of the QIP as each individual measure may prove relatively meaningless when calculating an overall performance score that determines reimbursement.  Additionally, the QIP should be a clear and easy to understand tool for beneficiaries to use when evaluating the quality of care a dialysis facility provides. This is why it is very important the information is understandable and that patients are included in the process when new measures are discussed.  

In our comments on the ESRD PPS on December 15, 2009, we listed several  measures we believed should be top priorities for inclusion in the QIP.  We recommend CMS work to adopt a consensus based approach to establish the specific measurements, and the weights they may be assigned, in the QIP on the following areas we believe best reflect quality care:

1. Blood transfusions
2. Mortality
3. Hospitalizations
4. Bone and mineral metabolism and subsequent related diseases
5. Vascular access infections and complicationsPatient satisfaction
6. Patient satisfaction

We also recommend that CMS work to ensure measures can be applicable to home dialysis patients.  It is important that incentives for quality address care delivered to all patients.

• Data collection and reporting delays
  

In order for the QIP information to be useful to patients the data used to evaluate the quality of care facilities deliver needs to be timelier.  Currently CMS is proposing a 2 year lag time in evaluating quality.  As new measures are introduced we recommend CMS collect a year’s worth of data on the measure to establish the baseline, but the baseline should then be used to compare the following year’s data.  There should not be a two year lag time in the future years of the QIP, as facilities may have improved their care by year two, but are still suffering the consequences from year one.  This also does not help patients receive accurate information on the quality of care their facility is delivering currently.  We hope that in the near future CMS will have the tools to report more timely data so that the QIP will be a relevant and useful tool upon which patients can use to make decisions about where they receive care.

We look forward to continuing to work with CMS on development of the QIP and on communicating program information to beneficiaries.

Sincerely,


 
Chad Lennox
Executive Director