With regard to his call for sticking with the engine #HR6331 directive, I think we should give serious consideration to changing to the science track, since the evidence shows that the “bridge-is-out” on the non-science track and the engine is about to fall into the financial abyss. Staying in lock-step with a severely flawed remedy lacking sound judgement, does not result in improved quality-of-care.

The incoming administration has called for the creation of a Federal Health Board that would promote “high value medical care…backed by solid evidence.” We whole-heartedly support their effort. Epoetin as a case study (and cautionary tale) is offered to the proposed Federal Health Board as an example of data needed to monitor quality of care as well as the an example of the conduct of a comprehensive technology assessment in support of sound public policy backed by solid evidence.

On rereading your initial post this section raised a question in my mind – is your contention that a 53% reduction is possible based on assuming that 8,100 units is the average dose across all providers rather than the average dose at one provider that dialyzes 30% of Medicare beneficiaries?

I have my doubts that a 50% reduction in usage could be achieved. I don’t think single payer health systems – from abroad or Kaiser – have seen those reductions.

“Our contention is that Medicare policy-makers should base their decisions on future payment for this service on a reasonable demonstration of “real-world” clinical effectiveness. We have reported such a study (Cotter D, et al Kidney Int. 2008) and application of these findings to policy formation could reduce current Medicare epoetin payments (~ $2.5 billion per year) by approximately 53%.” 12/26 comment

I think an assumption that units would use 50% less epo under an expanded bundle would mean a 14% reduction to the expanded composite rate instead of the 2% reduction currently required by HR6331 – the MMA, the legislation that created the expanded bundle. HR 6331 has a number of provisions – setting the reimbursement framework is a complicated business.

HR6331 includes provisions to withhold 2% of reimbursement from providers that do not achieve certain clinical performance measures (CPMs). Anemia management is one of those CPMs – providers face reimbursement penalties if Medicare beneficiaries in their care do not achieve hematocrits within a certain range.

This framework sets up a dangerous dynamic if a 14% reduction to the expanded composite rate was instituted. Anemia has an easily measured CPM so I think it is fair to assume that anemia management would be achieved. In this framework anemia management will be among the first to be paid as it were. If rather than a 50% decline, usage declines by 20% the imagined ESA savings will be taken from composite rate expenses without clear CPMs. Staff ratios will increase – patients will still have hematocrits in the 33 to 36 range but they will see their care team less often, have shorter runs and all the rest. Hematocrits will be achieved but a greater burden will be placed on the dialyzed.

I appreciate that you intended to limit the scope of discussion to ESA usage and the problems with creating future payments based on past, suspect, usage but I think the expanded bundle entwines ESAs with the whole of outpatient stage 5 CKD care. The egg is about to be wisked, under the circumstances I don’t think it makes sense to talk only about the yolk.

Anyone who follows my blog knows that I have always had a great concern about the wisdom of an expanded dialsyis payment bundle but I think it is too late to change the framework. I believe the HR6331 makes ESA reimbursement and dialysis reimbursement for all intents one and the same.

The implication of HR6331 is that going forward we have to look at the whole of CKD care, rather than any one element.

Bill Peckham
Dialysis from the Sharp End of the Needle

In “Bridging the Gap: The Use of Research Evidence in Policy Development,” Don Juzwishin and I argue that decisions should be based on research evidence, with particular attention to the most recent (in fact, one of the problems that Alberta identified early on in their health care reform efforts was using historical usage alone as a foundation for regional funding decisions tended to lead to inefficiencies in resource allocation). For decisions of the adoption of new technologies or the expansion of existing technologies to new conditions, we identified several categories of evidence that decision makers need or want: Social and System Demographics, Technology Effects and Effectiveness, Environment, Economics, Politics, Legislation and Ethics. In “Linking Evidence from Health Technology Assessments to Policy and Decision Making: The Alberta Model,” Henry Borowski, David Hailey and I collapse these categories into STEP, which collapses the Environment category into Technology, and collapses the last three into Public Policy. This latter paper also presents an eight-step decision process for health funders to go through, of which step 4 is a comprehensive search for and review of the evidence in all categories. Other steps include significant consultation efforts with key interest groups, including physicians and other providers.

Regardless of which mnemonic is used, the key elements are identifying the patterns of illness and the current patterns of care, as well as the ability of the health care system to make appropriate use of the new technology (S); the clinical effects of the technology being reviewed and its effectiveness in achieving these effects (TE/T); some form of economic evaluation or at a minimum a detailed costing of the provision of the technology (E); and some form of a political, legislative and ethical analysis of the decision to provide or fund the technology (PLE/P). Of course, such extensive decision processes are not without their challenges and every organization needs to find ways to adapt the model to its own organizational culture. Even in Alberta, the decision process based on this model is evolving and finding ways to become more proficient at using evidence effectively.

This comprehensive approach provides decision makers with an explicit approach to disease conditions and clinical indicators for which a specific technology is most effective. As such, it helps to guard against inappropriate indication creep, while allowing for a planned expansion of the use of the technology to other conditions, something that might be important in the case of epoetin, as it is for many new technologies, including drugs. This comprehensive approach also provides organizations with assistance in defining their evidentiary standards, and when these standards may be relaxed, in a systematic, meaningful and transparent way.

1) You are correct that CMS is explicitly forbidden by law to negotiate prices on Part D drugs, however EPO is administered under Part B. I believe the administration could negotiate epo directly without Congressional action. Indeed, reading incoming DHHS Secretary Daschel’s writings I think he is very supportive of using CMS’s purchasing power.

2 While I have great confidence in my dialysis provider to always do the right thing I do not assume all dialysis providers are as virtuous as the Northwest Kidney Centers. What I am calling for are process adjusters to payments that would pay providers for routinely increasing the available dose of dialysis. Providers and patients may decide that 3 hour runs 3 days a week are just fine but I believe they are deadly and I believe CMS has a moral obligation to allow access to more dialysis. Right now the expanded bundle is on track to entrench a one size fits all treatment regime and access to more dialysis is wholly dependent on ones zip code.

Keeping the thirteen treatment reimbursements a month framework (it is not clear what the payment frequency will be under the expanded bundle, I am assuming it will be kept the same) would be acceptable if process adjustments to payment made customized dialysis doses possible. For instance if a unit provided 4 treatments a week they could have the three paid treatments adjusted by 1.2 – at the end of the week they would have collected .6 of the expanded composite rate which would be the approximate cost of providing a forth treatment incenter sans the separately billable chagges that will soon be a part of the expanded composite rate.

I suggest other potential process reasons to adjust payment – process adjusters in addition to case mix adjusters. Adjusters for each home hemo training session (currently training is five days a week while payment is three times a week – this adjuster would be about 1.4), each PD training session (five traing sessions a week should garner the equivalent of five payments), for more frequent home dialysis (each treatment over three would increase an adjustment) and adjusters to maintain provider diversity i.e. adjusters that compensate for provider purchasing power disparities (for instance providers with fewer than 30 units would have all treatments adjusted by 1.1). Additional reimbursement would only reward those providers who provide additional services. No need to rely on provider’s beneficence.

3 Therefore, increasing dialysis dose might not effect patient mortality – researchers that have studied this issue are urged to weigh in on this topic. I disagree with this statement in the strongest terms. There is a lot of data to support my contention that more dialysis is healthier. Most striking are reports that nephrologists and renal nurses would choose high dose home hemodialysis for themselves. For studies look to Overnight Hemodialysis Dramatically Improves Survival; from Agar Flexible’ or ‘lifestyle’ dialysis: Is this the way forward?; and the important Kjellstrand et al paperwhich compared daily short hemodialysis to incenter hemodialysis and cadaveric transplant. There are many more.

4 I didn’t mean to advocate for phosphorus as the basis for Medicare premium discounts so much as point out that the person most in control of outcomes is the person receiving dialysis. However, I think phosphorus control has been shown to be important in maintaining the health of the dialyzed. The KDOQI targets are supported by evidence but units and docs are hard pressed to compel phosphorus control, which is why a patient focused incentive plan would be the only plan that could work. One can imagine other behaviors to reward – dialysis attendance, albumin measures – my point is … pay less for performance makes more sense then pay for performance when talking about a chronic disease.

5 I did not explain myself very well. I have great doubts about the relevance to people on dialysis of studies that showed a negative impact of high epo induced hematocrits in pre dialysis patients. I doubt the relevance of both the CREATE or the CHOIR studies and do not fear epo induced hematocrits between 36 and 38. The issue of safety in my eyes is entirely due to the low dose of dialysis provided incenter. Three hours of dialysis three days a week is very dangerous because it is not an adequate dose. Too little dialysis is dangerous. In my view epo doses have an inconsequential impact on dialysis survival compared to the impact of one size fits all dialysis doses.

Lastly, QoL seems to be secondary to the discussion you have initiated, a discussion I believe is of great importance. The critical issue is that we can use savings from CMS purchasing epo directly to provide customized dialysis doses. Ultimately I believe a three pronged approach – immunosuppressant coverage, increasing the routinely available dose of dialysis and CKD public health efforts – will achieve the critical goal of reducing the mortality rate of people with severe kidney disease.

1.) The simplest solution to this whole mess is for CMS to retain its buying power and negotiate the price of epo directly….If CMS were to act as a group purchaser for health care items/services, it would save the Medicare program billions! Previous efforts in this area have been squashed by a wide variety of stake-holders. This is an intriguing idea that Congress and CMS should pickup on now that the economy has taken a serious downturn. (Recall that Congress specifically stipulated that there were to be no negotiations on drug prices in Medicare Part D. This might change during the Obama administration.)

2.) Redirecting reimbursement from anemia management to dialysis …There is a presumption of beneficence among providers if you give them a generous epoetin adjustment to the ESRD composite rate. One of Ronald Reagan’s signature phrases was “Trust, but Verify”. As noted in my response to other blog participants, history (court rulings and testimony cited in the original posting and other responses) does not support the beneficence argument among at least two large for-profit chains. I’d like to think that this argument could be sustained among other providers, however. Public policy should not be based on presumption of goodness, although this is a common characteristic of the broad community of care-givers.

3.) Immunosuppressant support for the life of the graft, public health efforts (efforts independent of insurance coverage) to identify and treat early stages of chronic kidney disease, both go hand in hand with increasing the available dose of dialysis to reduce the mortality rate. … Unfortunately, studies have shown that U.S. providers appear to have reached a plateau with regard to URR (urea reduction ratio), which reflects dialysis adequacy. Therefore, increasing dialysis dose might not effect patient mortality – researchers that have studied this issue are urged to weigh in on this topic.

4.) Reward phosphorus control with premium discounts … We advocate evidence-based medicine; Mr. Peckman argues from a perspective of patient-centered care. Similar to documenting the clinical usefulness of epoetin, one would first have to determine an optimal target level for phosphorus control for the patient population. Based on such an analysis, one should first assign value to this service and second, determine how reimbursement policy could incentivize the practice. We have taken the first two steps to demonstrate an optimal level for epoetin therapy (i.e., dose-response and dose-survival work cited above) and now have embarked on testing anemia management strategies.

5.) safety will be improved if we spend less on medications and more on dialysis… The presumption is that current anemia-therapy practices carry a safety risk, a point that we have argued to Congress, GAO, MedPAC, FDA and of course CMS, unfortunately to no avail. If other drug treatments also have attendant risks, it would be prudent to assess such risks prior to including them in the ESRD bundle.

Finally, although not directly addressed in his HA comment, Mr. Peckham, as a patient, has raised quality of life (QoL) concerns in his “Sharp End of the Needle” blog. There is a presumption of QoL improvements among those who achieve higher hematocrit levels. The QoL claim was contained in the original FDA approved product label and recently removed from the current product label based on FDA’s review of existing evidence. The only allowed claim is the avoidance of the administration of a blood unit. (Although we have not studied QoL, I have been told anecdotally that patients who experience severe anemia and respond well to epoetin therapy experience less fatigue.) However, after almost twenty years of use, a well designed study to test QoL among epoetin responders and non-responders has not been reported.

You write: “… a conundrum that pits the interests of a single supplier(Amgen) against those of essentially a single payer (Medicare).” I don’t think that is quite right. Medicare subcontracts it’s purchasing power to dialysis providers. Under the current system CMS basically splits and dilutes its inherent buying power between two large dialysis providers, while they reimburse at a rate based on the purchasing power of smaller providers. The simplest solution to this whole mess is for CMS to retain its buying power and negotiate the price of epo directly.

Purchasing epo directly, removing financial incentives would mean spending less on epo but that is not an end in itself. The only meaningful end result would be to improve the provision of renal replacement. Redirecting reimbursement from anemia management to dialysis would allow providers to focus on dialysis rather than medication. Savings on anemia management would allow reimbursement adjusters for forth treatments incenter, reimbursement adjusters for each home hemo training session, each PD training session, for more frequent home dialysis and adjusters to maintain provider diversity i.e. adjusters that compensate for provider purchasing power disparities.

The job is not just to redirect money from anemia management, the real job is to reduce the number of people needing dialysis and to improve the care of those who, despite our best efforts, need renal replacement. Immunosuppressant support for the life of the graft, public health efforts (efforts independent of insurance coverage) to identify and treat early stages of chronic kidney disease, both go hand in hand with increasing the available dose of dialysis to reduce the mortality rate of those with severe CKD. Right now the number of new people requiring dialysis slightly exceeds the number of people dying and getting transplanted. Slowing this inflow of new patients would increase the value of existing patients, motivating providers to increase the dialysis dose.

The final way for anemia treatment resources to be redirected to good effect would be to create a pay less for performance scheme. Currently about 50% of all people on dialysis pay Medicare Part B premiums. Creating incentives to receive discounts on these premiums would finally direct financial incentives at the person with the most influence – the patient. Reward phosphorus control with premium discounts and you will see much better control of phosphorus. Patients are on their own over 90% of the time, it would be good policy to direct incentives towards those with the most influence on outcomes.

Being on dialysis for ten years should not be more dangerous than taking a ride on the Titanic; currently it is. We have the ability to make living with chronic kidney disease far safer. Stage 5 CKD safety will be improved if we spend less on medications and more on dialysis. This will be possible when Medicare reclaims its inherent purchasing power. Redirect, don’t cut.

Bill Peckham

(1) a system of continuous quality indicator for improvement – There is a profound distinction to be made between improvement in a quality indicator (e.g. surrogate endpoints such as hematocrit level or other lab values) and an improvement in a clinical outcome (i.e. reduced: mortality, myocardial infarcts, stokes, congestive heart failure events, etc.). Regrettably, based on CMS response to our previous inquiries, CMS is content to only monitoring changes in hematocrit levels as their measure of quality assessment and performance improvement (QAPI ) in anemia management of dialysis patients receiving epoetin. The clinical usefulness of this QAPI meaure is open to debate.

(2) a system of rewarding – Scholars and other pundits have raised ethical concerns with pay-for-performance schemes. I invite those that have thought about this dilemma to comment on the implications of such a program. Also, the reward would depend on what we agree with as a useful outcome described above (#1); i.e., what are we striving for?

(3) some sorts of oversight in order to protect public health – Epoetin therapy will continue to remain controversial until proponents of the therapy conduct and report on studies that demonstrate clinical benefit. With the current dearth of such information continuous monitoring of this practice will undoubtedly prevail. In fact, it still remains unclear what the optimal goal of therapy should be? What is the target hematocrit level that CKD patient should be targeted to? It appears that attaining a normal hematocrit level is not advisable? But what is the best target?

The ESRD program is the only U.S. national health care system. What is needed is a defensible rationale that supports a fair and equitable epoetin adjustment to the composite ESRD payment. This test will serve as a good barometer of success; as the country strives to remedy many other daunting challenges in the health care sector .