February 04, 2016

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Using a transitional start dialysis unit to improve modality selection

Introduction

There have been a number of articles published over the last several years looking at why home dialysis has shown little growth in the United States. The prevalent peritoneal dialysis patient population was 14.1% in 1996 and 9.69% in 2013, a near three percentage point drop over 17 years time. The prevalent home hemodialysis patient population was 0.96% in 1996 and 1.82% in 2013—a one percentage point increase.¹ Even though nephrologists have made it clear in surveys that they would encourage home dialysis for themselves, very few encourage it for their patients. ^3,4 I believe modality education is key to increasing the number of patients going home. But many patients don’t get that opportunity. The number of end-stage renal disease patients seeing a nephrologist for greater than a year prior to starting dialysis was only 30% in 2013, a slight increase from 23.4% in 2006. ^1,2 As a result, few patients gain enough knowledge about alternative therapies to make an educated choice. The percentage of incident patients starting PD in 1996 was 12.2% and in 2013 it was 9.2%, while the percent- age of incident patients starting HHD in 1996 was 0.87% and in 2013 it was 0.93%. In the U.S., we started 89.7% of our patients in 2013 on in-center dialysis as a default position.

We have done remarkably well over the past 10 years in reducing mortality for patients with ESRD. The most recent data shows a 25% drop. ¹ But could we be doing better with a higher percentage of patients dialyzing at home?

Dissecting the home vs. in-center imbalance

Many would suggest that the reason why the number of patients doing home therapies has stagnated relates to who we are starting on dialysis today: older patients with more comorbid conditions who nephrologists believe cannot handle the rigors of home therapies. But all patients, regardless of age or health, should be presented modality options. In 2008, the Centers for Medicare & Medicaid Services updated the Conditions of Coverage, the regulations that govern how dialysis clinics provide care in order to be eligible for Medicare reimbursement. The update includes a requirement that dialysis providers inform patients about all options of renal replacement therapy. If they cannot provide all of the options, the provider must refer patients to a clinic that can offer these services. ⁵

Major providers have created educational dialysis material to meet these guidelines. These programs, such as Baxter Live Now, DaVita Kidney Smart, and Fresenius Medical Care’s TOPS program, have joined others from non- profit organizations like the National Kidney Foundation and the Medical Education Institute.

But the concern is that these educational programs are not getting to the patients. A Government Accountability Office report released in October of last year said, “Medicare also pays for predialysis education— the Kidney Disease Education (KDE) benefit—which could help patients learn about home dialysis. However, less than 2% of eligible Medicare patients received the benefit in 2010 and 2011, and use has declined since then. According to stakeholders, the low usage was due to statutory limitations in the categories of providers and patients eligible for the benefit.” ⁶

Thus, in summary:

We continue to have a disproportionate number of patients on home dialysis therapy, a predominate modality choice 30 years ago, despite the fact that nephrologists themselves would select it as their therapy of choice.

Nephrologists may be reluctant to place their patients on home therapy because they tend to be older and sicker and may not be able to handle the rigors of self-care.

In order to qualify for Medicare funding, dialysis providers must pro- vide modality options education, and make sure that patients get access to the option they choose. Yet the major- ity of providers are not doing a good job explaining those options.

Looking at dialysis models overseas

Should we rethink how we approach our patients when they are at end-stage kidney disease and starting dialysis? Earlier, in-depth chronic kidney disease education is critical, but this is not working effectively. And even with early education, a large number of patients will not make choices about modality options because they “feel fine” or are “in denial” of their disease and do not accept dialysis or transplant as a possibility.

The renal care community in the United Kingdom believes that home therapies provide better care at a lower cost and their renal teams are approaching education of dialysis patients with a “Shared Care” model.⁷

In 2002, only 32% of dialysis patients in UK were seen by a nephrologist up to a year prior to starting dialysis; by 2013, that had increased to 70%.

However, the PD patient population is decreasing and the home hemodialysis population has grown slightly in the face of more patients being seen by a nephrologist one year prior to starting dialysis. ⁸In Canada, the kidney community feels home therapies provide better care at an optimal cost and are approaching education of dialysis patients with the concept of “Home First.” For ESRD patients who end up in acute care, they have a “Nurse Navigator” program that use nurses as the lead educator about modality options. ^9,10 Their goal is to have 40% of their population on home therapies using Home First and the Nurse Navigator program.

A U.S. approach

In the first 90 days of care when patients are new to dialysis, they are frightened, fragile, and susceptible to many problems. These can include access issues, hypotension and cramps, finding the appropriate target weight, adjusting medications and learning about diet and fluid restrictions. Patients also need to learn about different forms of renal replacement therapies and learn to adjust their life schedule to their dialysis schedule as they become more dependent on others and may feel like they are losing control.

The recent GAO report confirms that we should think about new ways to initiate dialysis within the ESRD Program, ways that incentivize patients and providers to do home therapies.

Drawing from the UK and Canadian experiences, one option could be to place patients in a transitional start unit. This approach could be a “win” for the patient, provider, and payee. The transitional unit allows staff to focus on fears and pre- conceived ideas about dialysis and find out about lifestyle and medical goals the patient has at initiation of dialysis. Once the patient is medically and emotionally more stable this unit allows staff to focus on renal replacement education. This would include transplant education if appropriate, home dialysis education, both HHD and PD, in-center education, access education and economic education. This approach would assure that all patients receive appropriate education about all modalities, access and economic issues when they are receptive because they feel better and are less frightened.

How it might look

Transitional start dialysis unit

Who qualifies?

Everyone. Patients for a transitional start unit can include those new to dialysis; those who have already failed at PD or HHD at home; failed trans- plant patients; and acute renal failure patients who do not know if they will need outpatient dialysis. The physician, nurse, dialysis administrator, or patient cannot avoid starting in this unit unless the patient has decided to do PD or HHD or is medically or men- tally unstable. The reason for starting all the patients in the transitional start unit is so all patients receive appropriate education about modality options .

Location

The transitional start unit should be located in an independent space that has the capacity of handling the maximum number of new starts that a provider would typically see on a monthly basis. Thus, if a provider starts six to 10 new patients per month on average, the transition unit should have a four to five station capacity. These stations should be plumbed and have electrical sources that sup- port the selected home hemodialysis machine, and should be approved by CMS as in-center stations. Ideally, this unit should also be in a separate functional space from the in-center unit or the home training unit, but could be in the same facility using common space associated with the in-center or home training unit.

How it works

Patients are started on a more optimal and gentler hemodialysis regimen in the transitional start unit. This is accomplished by using the home hemodialysis machine of choice, a blood flow of 300 to 350 ml/min, a dialysate flow 300 ml/min, treatment time of three to four hours, an ultrafiltration rate no more than 10cc/Kg/hour (max fluid removal 1000 cc/hour), and run four days per week (Monday, Wednesday, Friday and Saturday or Monday, Tuesday, Thursday and Saturday) to eliminate the “two-day killer gap.” This approach provides optimal renal replacement therapy with a flexible shift schedule that allows patients to fit their life’s schedule into the dialysis schedule, not their dialysis schedule controlling their life schedule.

Breakdown of a schedule

Week 1

The first week of education in the transitional unit would include making the patient feel better about how he or she is being dialyzed and explaining how dialysis works. During this first week, ask the patient about fears and preconceived ideas about dialysis, educate them on how renal disease affects them, and help them understand the cause of renal failure if known. Also review with the patient how dialysis is paid for.

Week 2

Give a general overview about renal replacement therapy options and use the patient decision tool called mydialysischoice.org to determine the top three lifestyle and medical issues that is important to the patient. Print the results sheet and keep it at the bedside so all caregivers will understand issues that are priorities for the patient. Also talk about outcomes data for each renal replacement therapy option and compare outcomes to breast cancer and prostate cancer that women and men can relate to. This is a major part of informed choice.

Week 3

During the third week of the transitional unit, there should be in-depth education about transplant if appropriate, education for all patients about home dialysis, PD and HHD, in-center dialysis, and education about vascular access options for PD, HHD and in- center. Also review outcomes data, quality of life data, and the top three issues that represent the patient’s goals.

Week 4

This week, review the economic and transportation issues as they relate to in-center, HHD and PD. At the end of the fourth week the patient, patient’s family support, nurse, and physician discuss what type of renal replacement therapy would best suit the patient’s lifestyle and medical goals. If the patient decides to pursue transplant, refer to the transplant center of patient’s choice. If the patient chooses home dialysis, refer to the home training unit, and if patient chooses in- center dialysis, refer to an in-center unit closest to patient’s home. Once again review access for their modality of choice and formulate a long-term plan for access. The transitional unit team should be very supportive of the patient’s decision . Leaving the transitional unit , the patient will be reassured that if this decision does not work out they can change their decision at any time.

Staffing the unit

If a provider decides that their needs will be six to 10 new patients per month, the unit should have a four to five station capacity. Staffing would be three RNs (one RN would be a part time nurse administrator), two dialysis technicians, a part time social worker, dietitian, nurse educator, and a medical director of the tran- sitional start unit.

The transitional team would develop the curriculum, decide who would be responsible for what component of each patient’s education, and the patient’s dialysis schedule.

The patients would run 3.5 to four hours per treatment on Tuesday, Wednesday, Thursday and Friday. During these days the unit would run two shifts of patients. On Monday and Saturday the patients would run only three hours per treatment but the unit

would run three shifts of patients. It is critical that the patient, the home training unit, and the in-center unit understand that after the patient completes their 16 treatments, their next treatment will be performed in the chosen modality unit.

The economics of the unit

If the patient has private insur-ance the provider would bill for four treatments while the patient dialyzes in the transitional start unit. If the patient has Medicare coverage because they are 65 or older or were on disability for reasons other than renal disease, bill for three treatments per week and if appropriate do medical justification for the fourth treatment while dialyzing in the transitional start unit.

If the patient has no insurance, bill for four treatments for the first month while dialyzing in the transitional start unit but expect that the ability of the patient to pay may be minimal. While in the transitional start unit, bill as if the patient is an in-center patient. The patient is not billed as if he or she is a home training patient

Other billing scenarios include:

If the patient starts on in-center dialysis and has no insurance, the provider should bill for three treatments for the first 90 days but expect that the ability for the patient to pay may be minimal. Medicare coverage does not start for 90 days for in-center uninsured patients. If a patient has no insurance once a patient starts home training either doing peritoneal dialysis or home hemodialysis, Medicare insurance coverage will start from the first day of the start- ing month of home training (may retro-bill Medicare to the first day of the month patient starts home training). If a patient qualifies for Medicare and Medicare insurance coverage is in effect, a new to dialysis patient gets 151% of the bundle for the first 120 days from the initiation of dialysis. The first 120 days on dialysis is more costly for the dialysis provider, thus CMS allows this additional increase in reimbursement.

If the transitional start unit patient chooses peritoneal or home hemodialysis, reimbursement (if they have private insurance) would be at the rate that provider and insurer has agreed on concerning reimbursement of home therapies.

If the transitional start unit patient chooses peritoneal or home hemodialysis, reimbursement for home therapies ( for patients that qualify or Medicare) would be 151% of the bundle three times per week for the first 90 days and then the provider would be reimbursed at the standard bundle three times per week plus additional bundle payments for medical justification.

If the patient that has no insurance goes in-center the patient would not qualify for Medicare for 90 days thus would only receive 151% of the bundle for 30 days then the provider would be reimbursed for in-center dialysis at the standard bundle rate three times per week.

The insurance coverage for the dialysis provider would coincide with how the nephrologist would bill for the comprehensive monthly dialysis services provided to the dialysis patient in the outpatient setting. If the patient has Medicare and is in home training, the nephrologist can bill for a training supervision fee of $500.00 if patient completes training or can bill for a percentage of the composite rate depending on length of time in training if patient does not complete training.

Conclusion

A Transitional Start Dialysis Unit will work. The patient wins by being empowered, finding the best renal replacement therapy and access for his or her life goals, improving quality of life and improving outcomes for a patient choosing home therapies and transplant. The provider wins by having about a third of their patients going on home therapies. This is a financial advantage because home patients live longer, thus grow- ing the ESRD population as well as decreasing the personnel and new facility cost. In the Accountable Care Organization model, the provider would win because of fewer medicines and fewer hospitalizations for home therapies. This approach should result in fewer central venous catheters at 90 days for appropriate patients, which is a win for the provider. The concern of having empty chairs in-center can be translated into dialyzing in-center patients with fluid overload, congestive heart failure, pulmonary hypertension, recurrent hypotension on dialysis and elevated phosphorus four times per week that can be medically justified for reimbursement for the fourth treatment in-center.

The payee wins by having more patients on home therapies and being transplanted, which results in less overall cost to the system. The payee also wins by empowering patients to care for themselves which improves the patients’ quality of life. This could result in the patient continuing to work or returning to work.

Transitional start units are being used in the US and Canada at present. Each location that considers starting a transitional start unit will balance their resources with their needs to provide more optimal renal replacement therapies for their ESRD patients. The CMS reimbursement system at present should incentiv- ize transitional start units.

References

US Renal Data System, USRDS 2015 Annual Data Report: Atlas of Chronic Kidney Disease and End-Stage Renal Disease in the United States, National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD, 2015.

US Renal Data System, USRDS 2008 Annual Data Report: Atlas of Chronic Kidney Disease and End-Stage Renal Disease in the United States, National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD, 2008.

Merighi JR, Schatell DR, Bragg-Gresham JL, Witten B, Mehrotra R. Insights into nephrologist training, clinical practice, and dialysis choice. Hemodial Int.2012;16 (2):242-51.

Berns JS. A survey-based evaluation of self-perceived competency after nephrol- ogy fellowship training. Clin J Am Soc Nephrol. 2010;5(3):490-6.

US Department of Health and Human Services, Centers for Medicare and Medicaid Services, Medicare and Medicaid programs; Conditions for Coverage for End-Stage Renal Disease Facilities; final rule (42 CFR Part 494.100), 73 Fed Reg. 20481 (2008).

GAO-16-125 October 2015 report: END-STAGE RENAL DISEASE: Medicare Payment Refinements Could Promote Increased Use of Home Dialysis

Yorkshire and The Humber: Sharing Haemodialysis Care, The Health Foundation

UK Renal Registry 17th Annual Report:2014

Jean-Philippe Rioux, Harpaul Cheema, Joanne M. Bargman, Diane Watson, and Christopher T. Chan. Effect of an In-Hospital Chronic Kidney Disease Education Program among Patients with Unplanned Urgent-Start Dialysis. Clin J Am Soc Nephrol 6: 799–804, 2011

Jennifer Hanko, Jacek Jastrzebski, Cheryl Nieva, Leigh White, Guiyun Li and Nadia Zalunardo. Dedication of a nurse to educating suboptimal haemo- dialysis starts improved transition to independent modalities of renal replacement therapy. Nephrol Dial Transplant (2011) 26: 2302–2308