Dialysis from the sharp end of the needle

My comment to CMS on the proposed 2012 QIP for ESRD

By Bill Peckham

The deadline to submit comments on: Changes to the End-Stage Renal Disease Prospective Payment System for CY 2012, End-Stage Renal Disease Quality Incentive Program for PY 2013 and PY 2014: Proposed Rule is, I think, past not up, there is still time! Regulation.gov site indicates you have to 11:59PM EDT August 30. http://www.regulations.gov/#!submitComment;D=CMS-2011-0129-0002

As with my past public comments (here, here, here) I post them:

Re: CMS-1577-P: Medicare Program; Changes to the End-Stage Renal Disease Prospective Payment System for CY 2012, End-Stage Renal Disease Quality Incentive Program for PY 2013 and PY 2014: Proposed Rule

Dear Administrator Berwick:

Thank you for the opportunity to comment on the proposed changes to the End-Stage Renal Disease Quality Incentive Program for PY 2013 and PY 2014 (QIP). My name is Bill Peckham. I have been a Medicare beneficiary since 1988 and have used dialysis since 1990. My comment primarily concerns the proposal concerning anemia, so I note that I have used ESA therapy in the past though for the last  ten or so years with diminished frequency and as of today it has been nearly four years since my last dose; today I have a normal red blood cell count and thus do not, at this time, use ESA therapy.

I work as a sign maker, through the union, in the tradeshow and hospitality industry. I volunteer in various ways to promote the optimal health, quality of life and independence of people who use dialysis. I volunteer both with my provider, Northwest Kidney Centers, where I am immediate past trustee board chair and continue to serve in many ways, locally with the Kidney Research Institute, on the KRI Council, and nationally on the oversight committee of a federally sponsored comparative effectiveness research project, with DOPPS, on their steering committee and I volunteered to serve on the recent C-TEP looking for fluid management CPMs last year. Through my blog, Dialysis from the Sharp End of the Needle and participation in the CKD online community I've made many connections with people involved with the provision of dialysis, on both ends of the needle, and have had many discussions, over many years, about the details of Medicare reimbursement policy for those with severe kidney disease. The reimbursement details of CMS's ESRD program is my hobby; one I take seriously.

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 effected dialyzors report, limits their energy and thus diminishes their quality of life.

Given this developing trend it is a particularly risky time to make the changes proposed in CMS-1577-P. Specifically, the proposal to eliminate the performance measure (CPM) "percentage of patients at a facility whose hemoglobin (Hgb) levels were less than 10 grams per deciliter (Hgb=10)" will magnify this trend to the detriment of your beneficiary's quality of life. 

A close reading of the FDA label change suggests that a Hgb=10 is a valid treatment threshold (link: http://www.fda.gov/Drugs/DrugSafety/ucm259639.htm ):

• For patients with CKD on dialysis:Initiate ESA treatment when the hemoglobin level is less than 10 g/dL.If the hemoglobin level approaches or exceeds 11 g/dL, reduce or interrupt the dose of ESA.

This guidance suggests that a threshold of 10 g/dL is appropriate and complies with MIPPA's language that “measures on anemia management that reflect the labeling approved by the Food and Drug Administration for such management”.

I propose that CMS continue the QIP's support of the FDA label's treatment threshold of Hgb=10 for payment year 2013 and 2014. 

However, to improve the QIP and allow for care that is tailored for each beneficiary the QIP should move away from both the Hgb=10 and the Hgb=12 CPMs, to an anemia CPM that reinforces best practices and gives your beneficiaries a voice in their anemia management.  

I propose that CMS institute a new QIP CPM:  "percentage of patients at a facility whose hemoglobin grams per deciliter levels were more or less than ten percent of the Monthly Capitated Payment (MCP) Physician's target hemoglobin for that beneficiary" (%+/-Hgb Target).

In this year's final QIP final rule, CMS should propose using 2012 outcomes of a %+/-Hgb Target CPM as a benchmark to implement this new CPM in 2013 effecting payment in 2015.

I believe this makes sense because CMS is paying the MCP Physician to manage their beneficiary's renal replacement therapy, including anemia management. Thus it is appropriate that the QIP motivate units to put the MCP Physician's clinical judgment into practice. The NQF did not evaluate anemia CPMs based on the MCP physician prescription but I believe the Secretary has the discretion to take this approach under the exception clause of MIPPA Sec 153(c)(2)(A)(i). 

I like this approach because the beneficiary can be included in the discussion as to where to set their personal Hgb target allowing the MCP physician to take their patient's view on the trade offs between a Hgb=11 vs a Hgb=9 into consideration when setting an individualized goal. Basing the goal on the MCP physician's judgment allows individualization in the framework of existing rules. Requiring MCP physicians to set and monitor the target should not be a burden since it is very nearly what is required today. This could be implemented by 2012.

One concern will be how to collect the information, how to report the MCP Physician's Hgb target. I suggest including the target with the reporting requirement to note ESA Route of Administration. Starting this January providers will be required to include the modifiers JA (intravenous administration) or JB (subcutaneous administration) indicating the route of administration on all ESRD claims with dates of service on or after January 1, 2012. Along with the route of administration, units should also be required to report beneficiary's MCP Physician's Hgb target. From there it would be a simple math equation to determine the unit's performance.

This approach to the anemia question would help to reinforce the role of the MCP physician as the medical professional in charge of the individual treatment details of each of your beneficiaries who use dialysis. The dialysis unit is being paid to implement a care plan that they jointly develop with the patient and the doctor, the proposed CPM would reinforce these separate roles. 

Taking this approach forward the MCP physician's prescription could form the benchmark for other CPMs from the dialysis unit to the hospital. Meaningful CPMs related to bone health and Kt/v are very difficult to develop if they are meant to apply to every person using dialysis. I think a better approach would be CPMs based on the MCP physician's prescription for each beneficiary. The beneficiary's personal calcium, PTH, Kt/v and phosphorus targets would make useful CPMs. By showing confidence in the judgment of the doctors you employ to manage our care the QIP can implement CPMs that have much more meaning to the lives of your beneficiaries.

Sincerely,
Bill Peckham
Seattle WA

It may be that this time I veered too far to the quixotic and my comment doesn't fully meet my goal to offer thoughtful and actionable feedback. My focus these days is more on work, less on hobbies; it's hard to stay up to speed.

The QIP should establish a new CPM: Hgb +/- 10% of MCP Physician target

By Bill Peckham

The Centers for Medicare and Medicaid Services (CMS) has a public comment period open right now for you to comment on proposed changes to CMS's ESRD Quality Incentive Program (QIP) that was mandated by Section 153c of H.R. 6331: Medicare Improvements for Patients and Providers Act of 2008 (MIPPA).

The most important proposed change from last year's QIP rule (PDF link) is the elimination of the Clinical Performance Measure (CPM): "percentage of patients at a facility whose hemoglobin (Hgb) levels were less than 10 grams per deciliter (Hgb=10)". I supported the below Hgb=10 penalty in my 2010 comments because I felt that the inherent nature of the bundle would put a tremendous downward pressure on the use of the class of ESRD anemia correcting medications called, Erythropoiesis-Stimulating Agents (ESAs): Procrit, Epogen and Aranesp.

This proposed elimination comes in light of the FDA's new lable which recommends:

• For patients with CKD, consider starting ESA treatment when the hemoglobin level is less than 10 g/dL. This advice does not define how far below 10 g/dL is appropriate for an individual to initiate. This advice also does not recommend that the goal is to achieve a hemoglobin of 10 g/dL or a hemoglobin above 10 g/dL. Individualize dosing and use the lowest dose of ESA sufficient to reduce the need for red blood cell transfusions. Adjust dosing as appropriate. 

The drug label previously recommended that ESAs should be dosed to achieve and maintain hemoglobin levels within the target range of 10 to 12 g/dL in CKD patients. This target concept has been removed from the label.

In order to put the QIP in concert with the label change (as required by Section 153(c) of MIPPA) CMS proposes to use just two measures for the 2013 QIP penalties (based on 2011 outcomes) Hgb >12 and URR <65%. The proposed rule also includes a payment update of 1.8% (the first in the program's history that did not require a specific Act of Congress) and eight future measures (2012 performance; 2014 payment):

• Dialysis adequacy, as measured through the Kt/V method, which is widely recognized as a more accurate measure of whether dialysis cleanses blood effectively
• Anemia management, as measured by the rate of patients with a hemoglobin level greater than 12 grams per deciliter;
• Percent of patients receiving treatment through an arteriovenous fistula – a type of vascular access used to connect patients’ bloodstreams to dialysis equipment for cleansing;
• Rates of infection of the vascular access sites;
• Ratios of hospitalization rates among dialysis clinic patients;
• Whether the facility reports certain dialysis-related infections to the Centers for Disease Control & Prevention;
• Whether the facility administers a patient experience of care survey; and
• Whether the facility monitors phosphorus and calcium levels on a monthly basis.

Comments are due by end of business Monday.

In my comment I will propose that CMS stop including any Hgb numbers in its QIP and instead stake half of the QIP penalty (1% of unit reimbursement) on a new CPM: "percentage of patients at a facility whose hemoglobin grams per deciliter levels were more or less than ten percent of the Monthly Capitated Payment (MCP) Physician's target hemoglobin for that beneficiary".

In their final rule, CMS should propose using 2012 outcomes as a benchmark and implement this new CPM in 2013 effecting payment in 2015.

I believe this makes sense because CMS is paying the MCP Physician to manage their beneficiary's renal replacement therapy, including anemia management. Thus it is appropriate that the QIP motivate units to put the MCP Physician's clinical judgement into practice.

I like this approach because the dialyzor can be included in the discussion to set the target and the doctor can take the dialyzor's view on the trade off between a Hgb of 11 v a Hgb of 9 into consideration when setting an individualized goal.

One concern will be how to collect the information, how to report the MCP Physician's Hgb target. I suggest including the target with the reporting requirement to note ESA Route of Administration. Starting in 2012 units are required to include the modifiers JA (intravenous administration) or JB (subcutaneous administration) indicating the route of administration on all ESRD claims with dates of service on or after January 1, 2012 (PDF link). Along with the route of administration, units should also be required to report beneficiary's MCP Physician's Hgb target. From there it is a simple math equation to determine if the unit's performance was within 10% of the target.

The other concern is what will happen between now and when a more appropriate CPM can be implemented in 2013? With their final rule Medicare must send the message that they expect units to provide the care prescribed by the MCP Physician and act with deliberate haste to align the QIP with outcomes that matter to the dialyzed and enable CMS to meet the intent of the MIPPA (Section 153c): to motivate the safe achievement of optimal outcomes.