I’ve just now sent in my comments. I found it hard to get what I am thinking on paper, I blame the virus that has been kicking my but for hte last four days but during the Open Door Forum CMS did say they anticipated a rule making process next year when they have to come up with how the QIP will work in 2013. So with that in mind here’s what I submitted:
Dr. Donald Berwick
Centers for Medicare and Medicaid Services
RE: Proposed Quality Improvement Program for ESRD (CMS-2010-2019)
Dear Administrator Berwick:
I live with stage 5 chronic kidney disease (CKD5), and have been a Medicare beneficiary under the ESRD entitlement since 1988 when I had a preemptive transplant (I was 24 at the time; 47 today). My underlying condition - FSGS - recurred after just 26 months. Thus, since September 1990 I have treated my kidney disease with hemodialysis (HD). Initially I used conventionally incenter HD but for the last nine years, since September 2001, I have enjoyed using a healthier, more frequent dose of HD in the comfort of my home.
I have served CMS as a technical expert, most recently on the Fluid Weight Management C-TEP (Baltimore, March 2010) and previously on the Dialysis Facility Compare TEP (Baltimore, December 2005). My expertise is due to my personal experience using dialysis and my volunteer and advocacy activities over many years.
I currently volunteer as an Emeritus Trustee and Senior Council for the nonprofit Northwest Kidney Centers, having previously served as a trustee (1997-2009) and board chair (2007-2009). I continue to serve on various Northwest Kidney Centers committees and on the board of Northwest Kidney Centers Foundation. I helped to found the Kidney Research Institute (a partnership between Northwest Kidney Centers and University of Washington School of Medicine) where I serve on the Council. I am a Dialysis Outcomes and Practice Patterns Study (DOPPS) Steering Committee member and a member of the DOPPS Patient Centered Care and Quality of Life task force. I recently joined the AHRQ DEcIDE ESRD Expert Stakeholder Advisory Group of Johns Hopkins DEcIDE Comparative Effectiveness in ESRD Study.
And lastly, through my non-commercial, informational blog, Dialysis from the Sharp End of the Needle (www.BillPeckham.com) I track renal industry news and trends, in advocacy, reimbursement, politics and the provision of dialysis. I do my kidney related activities as a volunteer (though some activities provide honorariums), my paid work is through the carpenter’s union, where I am a journeyman tradeshow specialist.
As a home hemodialysis advocate I have joined a QIP comment submitted by the Home Hemodialysis Workgroup but I understand that for the most part the QIP is not about people who dialyze at home. The people who will most benefit from an ideal QIP are the 90+% of ESRD beneficiaries who use conventional incenter dialysis. The following comments are offered with people who use incenter dialysis in mind.
I want to offer constructive and actionable comments on the proposed QIP but I have to say I found the proposed End-Stage Renal Disease Quality Incentive Program uninspiring. I don’t think a Total Performance Score comprised of the three proposed measures gives a meaningful insight into the quality of care at a dialysis unit. However, given the constraints of the process I think what you have proposed makes sense for 2012, thus these comment are directed more on how to use the QIP in future years.
I am inspired by your request on page 47 of the proposed rule:[INDENT]We are particularly interested in comments on how we can educate Medicare beneficiaries and their families about the presence of certificates in dialysis providers/facilities and how the information can be used to engage in meaningful conversations with their dialysis caregivers and the clinical community about the quality of America’s kidney dialysis care.
[/INDENT]I would change that just a little. I believe that if, Medicare ESRD beneficiaries engaged in meaningful conversations with their community of clinicians about the quality of THEIR kidney dialysis care then, THEIR care would improve and the sum of individual improvement would be program wide improvements. That is a worthy goal for the QIP. Unfortunately, I don’t think the proposed Total Performance Score will motivate this discussion.
In offering comments the temptation is to expand the Total Performance Score with additional measures. As you note in the proposed rule there are many candidates but I would advise against this strategy. I believe that each additional measure will decrease the impact of the withhold. I propose to maximize the impact of the withhold; I recommend focusing the withhold on a single measure – Hgb under 10. And in turn I would report only Hgb under 10 on the certificate.
The nature of the recently expanded dialysis payment bundle (PPS) creates a strong financial incentive to under-use EPO. Given this incentive there is no need to include a greater than 12 Hgb measure as a component of the financial incentive potion of the QIP. And given the nature of urea there is no compelling reason to use a URR greater than 65% measure as a component of the financial incentive potion of the QIP. Urea is of some value because it is inexpensive and easy to measure but it is a poor marker of quality dialysis. I think urea based measures and Hgb over 12 can play a role in a beneficiary based reporting element of the QIP but should not be used to determine the QIP’s financial withhold.
If the financial incentive potion of the QIP is meant to penalize inappropriate cost cutting by dialysis providers in response to the new PPS, and I believe it is, then the withhold should be focused on the area widely identified as ripe for trouble. The financial incentive portion of the QIP should be focused on the under use of EPO, with under use, as defined by the FDA label, being evidenced by a Hgb less than 10. Focusing the financial incentive potion of the QIP on Hgb less than 10 is appropriate. The QIP’s withhold of 2%, when applied to the new average case mix adjusted bundled reimbursement, amounts to $5 per treatment, significantly less than the ~$8 the Office of the Inspector General recently reported as the provider’s approximate purchase cost of a unit of EPO (1000mcu).
By focusing both the withhold and the certificate on Hgb <10 the QIP will maximize its impact on one area of care solely under the control of the dialysis provider. By focusing on Hgb <10 the certificate would be able to convey a clearly understood result to patients: CMS believes its reimbursement rate is enough to maintain your Hgb above 10; this is how this unit preformed … The combination of a financial stick and public shame offers the best chance to keep providers from inappropriately cutting costs by an inappropriate under use of EPO.
However, quality dialysis is more than a properly maintained Hgb and the unit’s efforts at anemia management, no matter what the result, is unlikely to spark a meaningful conversation between those who dialyze and those who care about and for us.
I believe a reporting regime that provides beneficiaries with their own timely, data rich report card, would improve the quality of dialysis and thereby improve Medicare’s ESRD beneficiary quality of life by motivating the meaningful discussion you rightly seek. However, to do this, the reporting element of the QIP should develop Clinical Performance Measures (CPM) that are in addition to the CPM that puts reimbursement at risk.
The QIP should present beneficiary results in the context of the unit’s results (and the state, network, nation) and in the context of guidance set forth via TEPs and National Quality forums. I think that this change, allowing a CPM to inform the QIP reports to beneficiaries rather than using a CPM to put reimbursement at risk, would be liberating to those working on formulating measures. It would allow more aggressive guidance to encourage optimal dialysis. Using the CPMs to inform guidance to beneficiaries would allow for TEPs to set benchmarks for optimal dialysis, rather than setting measures at the threshold of adequate.
The QIP should report to beneficiaries their results e.g. hospitalizations, infections, UFR (ml/kg/hr), measures of bone health, and their KTV and Hgb, in the context of the unit’s results (and the state, network, nation) and against CMS guidance. With this information beneficiaries would be prepared to engage in a meaningful conversation with their community of clinicians. Reporting back to beneficiaries would also be a check on data e.g. hospitalizations, infections, patients could confirm data that may not be fully captured by current systems.
Ultimately the QIP should measure and report the illness burden experienced by a beneficiary. Over time the ESRD program has developed a cost shift of sorts. The disease burden has increased for beneficiaries as shorter treatment times require tighter dietary control and more recovery time; as higher staffing ratios require less time for education and personalized care; and as expectations decline resulting in less rehabilitation, and fewer beneficiaries feeling well enough to work or otherwise lead the lives they were meant to live but for their bum kidneys. A well designed QIP could push back on this trend by letting beneficiaries know if their illness burden is greater than what should be expected. Reporting results in this way would allow beneficiaries to compare their experience with their peers. To be truly meaningful and actionable to beneficiaries, the QIP should seek to report a Total Illness Burden for the beneficiary rather than a Total Performance Score for the unit.
In addition to the QIP CMS could quickly communicate unit performance on many meaningful measures by making public the Dialysis Facility Reports each unit receives, each year. It is a mistake to believe beneficiaries are helped by shielding them from the actual DFR data. The data can be explained and put into context by the many patient service organizations but it is insulting to think that CMS chooses to keep the actual data from their beneficiaries because it is “too complicated “ or will “upset people to know the facts”. Treat your beneficiaries as adults and they will act like adults. Give them information to inform the discussions we all want.
I encourage CMS to use the QIP to engage beneficiaries in their care. Use the statistical communication resources that produce the USRDS Annual Dialysis Report or the yearly Dialysis Facility Reports to present the data. Do not dumb the data down. It may be that the measures will evolve to suggest a single score with meaning, but until then treat your beneficiaries as the adults they are and error on the side of complexity. I believe the community can learn to use sophisticated measures and to understand that for each individual the measures have to be viewed in the context of a complicated disease process. We’ll learn, challenge us with our real data.