CMS-5527-P: Comments Submitted on the ESRD Treatment Choices (ETC) Model—Hemodialysis

Six additions to the ETC model would first, materially increase the probability of shifting hemodialysis away from the present institutional in-center model to the lower cost home model and second, more fully achieve the promise that the home model offers a better life for patients to feel better, live longer, avoid dependency and regain their role in society and the economy.

This strategy could end the unintended consequence of the 1972 legislation ² which planted the seeds for institutionalization of dialysis—now characterized by short, aggressive, insufficiently frequent treatments. The assumption that normal kidneys functioning 168 hours/week can be satisfactorily replaced by an imperfect substitute functioning 9-12 hours/week is a tragic myth—a myth sadly documented by the irony that American nephrologists who prescribe this inadequate treatment for their patients would overwhelmingly avoid institutional dialysis and elect dialysis at home should their own kidneys fail! ³

Northwest Kidney Centers in Seattle, first in the world to offer chronic dialysis services in 1962, followed up with a review of its experience in 1970, concluding that home dialysis was both more effective and less expensive and discontinued in-center dialysis, except for patients in training or requiring hospital-level care. ⁴ Within months about 80% of its patients were dialyzing at home, supported by patient reimbursement of all associated costs. Unfortunately, this breakthrough was inadvertently destroyed by the same 1972 Social Security amendment, which described kidney failure as a disability, which made it a benefit under Medicare available to patients all ages—but led to a home payment model that failed to cover important costs associated with home dialysis; triggering its near-total demise and setting the stage for institutionalizing dialysis.

Transitioning from the long entrenched institutional hemodialysis model back to the home model will not be easy. Integrating the following six recommendations into the ETC model design will materially enhance the probability of achieving that goal:

1. Change reimbursement of hemodialysis providers from bundled payment per treatment to bundled payment per treatment hour to end the present conflict between the financial interest of providers in providing the shortest possible treatments to maximize revenue and the well-being and survival interest of patients in longer, more frequent treatments—practical only at home. This change will motivate providers to utilize every minute of idle in-center capacity to extend existing patient treatments, rather than to hoard idle capacity for hoped-for billable new patient treatments. ^{5, 6} Patients transitioning from institutional to home treatment now reduce provider costs, but this incentive alone has failed to materially expand home treatment. In contrast, under the per treatment-hour formula, patients transitioning to home would not only reduce provider costs, but also increase provider revenue—multiplying the provider incentive. Medicare would annually reduce the national treatment-hour reimbursement rate to capture the current national average savings of dialysis at home—including recapture of reimbursement increases resulting from increased hours at home. Marginal cost for providers of increased home patient hours is minimal—while the benefit to patients is great. (Importantly, small dialysis providers and rural patients will need to be appropriately protected). In sum, dialysis centers achieving higher percentages of home patients—and hence with both higher revenue and lower patient costs—would be significantly more profitable than lagging centers. Providers will have a substantially increased incentive to encourage and effectively support patients going home. The present conflict of interest between providers and patients will evaporate. Medicare will start to pay for value—the time patients’ blood is being processed—not merely for connecting and disconnecting patients to a machine!
2. Reimburse patients for the full costs of dialyzing at home, including reimbursement for employment and training of a helper when needed, thereby eliminating the financial barrier to adopting home dialysis now confronting many patients. The 1972 Medicare regulations failed to provide such reimbursement and doomed home hemodialysis, which subsequently plummeted more than ten-fold—inflating Medicare costs and diminishing the well-being and life expectancy of countless patients.
3. Eliminate the Medicare “Coordination of Benefits" policy, which flips primary/secondary payer status between higher paying private insurers and lower Medicare payment after the 33^rd month of dialysis, resulting thereafter in continuing provider losses, assuring that providers have a financial interest in their patients’ deaths. ⁷ Ending this death incentive would also eliminate the linked provider disincentive to invest in practices and technologies designed to extend patients’ lives.
4. Resolve the now intractable conflict between patient opposition to more hours in the dialysis chair and their too often unrecognized need for longer, slower, gentler, life-preserving treatment by establishing nocturnal dialysis at home as the standard of care. This conflict perpetuates short, aggressive, inadequate treatment. Nocturnal dialysis, however, offers greatly extended treatment hours while sleeping with minimal effect on patients waking hours (or provider costs). Less than an hour is needed to gather supplies and start treatment and less than an hour to end and clean up. Daytime home dialysis requires nearly 6 hours for a 4-hour treatment. Done in-center, it adds 1-2 more hours for traveling/waiting. Patients resent, resist, and often refuse lengthening treatment without understanding the damaging consequences. Lengthening in-center treatment is also adverse to the financial interests of their center, a disincentive to educating their patients. Sadly, the outcome for patients always seeking to minimize dialysis time is the resulting loss of opportunity to regain a normal life. Feeling sick for hours following the usual aggressive in-center treatment too often precludes employment or school and creates conditioned dependency. A major reason that patients—and many professionals—do not understand the impact of aggressive dialysis vs. long, slow, frequent dialysis may be traced to the failure of the Frequent Hemodialysis Network nocturnal trial authors to publicly recognize and brand this trial as a failed study. Its confused results were the consequence of a fatal mid-study protocol change, which facilitated evident protocol violations, together with grossly inadequate sample size. In fact, this study should never have been published!
5. Urgently seek to remove the formidable psychological and skill barrier to home hemodialysis associated with requiring large needle insertion into an arteriovenous fistula for blood access by eliminating the higher infection risk historically associated with simple, quick, painless central venous catheter access. New patients often receive a CVC to initially start dialysis, because fistulas require many weeks to “mature” and be ready for use, so CVC and fistula surgical costs are both incurred. The research literature describes techniques for achieving this goal (and with which the writer has had successful experience), but they must be suitably validated before becoming widely accepted and routinely prescribed by nephrologists. Ending the old mantra of “Fistula First -- Catheter Last,” removes a formidable barrier to home dialysis. Funding the necessary studies leading to removing this barrier is crucial to the success of the ETC model, if it is to meet its 80% home/transplant objective.
6. Require high quality training and support to minimize dropouts. Anyone with the mental, emotional, physical and language capabilities required to learn to safely drive a car can learn to safely perform dialysis. To overcome historically high dropout rates patients must be well trained and supported through their initial fear until they have mastered dialysis equipment, processes, and problem resolution and demonstrated the necessary competence and confidence. Home dialysis should be the goal at the outset of treatment for all patients who are not specifically disqualified by their physical or health status, and their training should begin with their very first in-center dialysis treatment. Today, too many centers actively discourage patients touching their machine…or even locating it in within patient view. The recommended change to per treatment-hour reimbursement, however, will incentivize centers to train patients as early as possible for transition to home dialysis… with the prospect of increased billable hours. In-center patient TV displays should provide relevant knowledge to reinforce training, not just soap operas. Highly skilled, 24/7 centralized real-time equipment and clinical telephone support must be at hand after patients commence dialyzing at home—centralized support from machine manufacturers has worked well for equipment issues and should be extended to include clinical issue support. Availability and quality of clinical support from individual clinics is now much too uneven and inefficient. Combined support will be more cost effective and eliminate the confusion from occasional gray areas between clinical and equipment issues for patients.

Dialysis Patient Impact

If the ETC model succeeds and becomes the national model, patients would have the opportunity to leave behind the debilitating symptoms of kidney failure treated with in-center aggressive dialysis—its “crashes,” phosphate binders, hours of post-treatment misery, near-impossible diet restrictions and life-limiting, intrusive daytime schedules. They could then look forward to rejoining society and the economy as well as a more normal life expectancy.

Clearly, with this opportunity would come choice…and with each patient’s choice would come consequences. The consequences would depend almost entirely on the treatment schedule each patient elects to follow at home.

In 2002 Belding Scribner, who was deeply involved in birth of hemodialysis in Seattle in the 1960s…and would become one of the most honored nephrologists in the 60-year history of dialysis, and Dimitrios Oreopoulos, his similarly esteemed Canadian coauthor, published, “The Hemodialysis Product (HDP): A Better Index of Dialysis Adequacy than Kt/V,” ⁸ an article that would be honored on its 10^th anniversary by reprinting and has been cited thus far in 64 subsequent articles in the nephrology literature, The authors provided a simple, empirical formula:

HDP = (hours/dialysis session) x (sessions/week)²

To determine the best dialysis dose, they pointed out “For experienced patients who have had a high enough dose of dialysis to really regain a sense of well-being—such as those with an HDP above 70— ‘how they feel’ is the simplest, most reliable guide of all.” Scribner and Oreopoulos also described the consequences of various hours per session and sessions per week combinations, all significantly superior to current institutional practice. ⁹

It’s not going home that matters,
it’s the optimal dialysis dose, available only at home.

Dialysis Provider Impact

Businesses following these six recommendations would:

• Shift away from in-center treatment and toward patient home training, logistics, equipment maintenance and remote equipment and clinical support.
• Experience accelerated growth as more home patients dialyze longer…and live longer
• Become less labor intensive… and less vulnerable to union organization with its higher costs for providers and Medicare (already sought in California through a recent ballot initiative).
• Benefit from the stimulation of home dialysis machine R&D resulting from much higher home volumes, leading to superior, lower cost machines replacing now mostly two decades old technology and requiring less patient training and support.
• Experience declining home dialysis logistics costs as volumes increase

For a few years, provider profitability per patient would be at risk if it fell behind its peers as Medicare exploited the shift from in-center to home dialysis through annual reduction of the national “per treatment-hour” reimbursement rate…until a provider’s home penetration approached the national qualified patient saturation rate. Profitability for providers staying ahead of their peers would grow—and at higher and higher rates—as still more of their patients shifted to home treatment. It is difficult to think of any business that would not ultimately benefit from its regular customers living longer… and a seemingly endless, growing supply of new ones as far as the eye can see.

An often-cited definition of insanity is to keep doing the same thing and expect a different result. Consider the challenge: Medicare targets that by 2026 with ETC 19% of all Medicare patients on dialysis in selected geographic areas will be dialyzing at home; double the present rate. But without bold changes it is unlikely that this projection has a significant chance of overcoming many decades of entrenched practice and patient conditioned dependency. Incorporating these six recommendations into the ETC model would materially increase its chances.

In 2002 the author’s then 73-year-old wife’s kidneys failed, and on recommendation from her nephrologist, she commenced 6x/week nocturnal hemodialysis at home, always with central venous catheter access. Despite a survival projection from the U.S. Renal Data System Data of 16 months, Jane survived for more than 12 years with few ESRD symptoms or restrictions. Mel, Jane’s caregiver, undertook continued dialysis study informing her treatments in consultation with her nephrologist and also leading to authoring a number of published articles in the nephrology literature, some referenced in these recommendations.