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Peritoneal dialysis growth in the U.S. encounters unexpected hurdles
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Home dialysis therapies—both peritoneal dialysis (PD) and home hemodialysis (HHD)—are important treatment options for patients with stage 5 chronic kidney disease. These modalities generally offer meaningful clinical advantages and significant quality of life benefits. These home therapies, however, specifically PD, have traditionally not been utilized to their expected potential.
This is interesting when one considers that there are no absolute medical contraindications to its use for the majority of patients.1 The reasons for the underutilization are multifactorial, but in part relate to:
- A lack of adequate physician training
- Provider infrastructure-related issues
- Unanticipated financial incentives that had favored use of in-center HD.
Another factor that has negatively impacted the overall growth of home therapies has been the high rate at which patients abandon these therapies after training. This attrition has been attributed to technique failure, loss or exhaustion of care partners, and technical issues such as access malfunction and loss of ability to maintain volume homeostasis.
Some growth seen
Home dialysis utilization has grown recently and according to the US Renal Data System’s 2015 annual report, 10.2% of incident patients and 11.5% of prevalent patients were utilizing home therapies at the end of 2013.2 The recent change in 2011 to a “bundled” reimbursement policy (Centers for Medicare & Medicaid Services) has removed one of the hurdles to home dialysis.
Overall, home dialysis utilization is about 70% higher than its nadir in 2007, with the largest growth (> 50%) occurring over the past 10 years. According to self-reported data from the 10 largest dialysis providers in the United States, the number of PD patients increased from 34,067 at the end of June 2013 to 41,624 at the end of June 2016, a 22% increase from mid- 2013, while HHD increased from 5,783 to 6,932 patients, a 20% increase over the same time period.3
The CMO Initiative
The chief medical officers of the 13 largest dialysis providers have closely collaborated over the past years on clinical issues surrounding kidney care in an effort to jointly advance well-being and outcomes for patients requiring renal replacement therapy. A review of the growth and improved outcome with home dialysis therapies has resulted in the CMOs’ aligned motivation to further emphasize the benefits of home dialysis therapies for ESRD patients and at the same time put a spotlight onto the existing obstacles impeding the desired penetration of home dialysis in the US.
CMOs who have endorsed this paper
Allen R. Nissenson, CMO, DaVita Kidney Care
Frank W. Maddux, CMO, Fresenius Medical Care
Doug Johnson, CMO, Dialysis Clinic Inc.
J. G. Bhat, CMO, Atlantic Dialysis Management Services
Stan Lindenfeld, CMO, US Renal Care
George R. Aronoff, CMO, Renal Ventures Management
Leanna B. Tishler, Medical Advisor, Northwest Kidney Centers
Jeff I. Silberzweig, CMO, Rogosin Institute
John H. Sadler, CMO, Independent Dialysis Foundation
Michael Anger, CMO, American Renal Associates
Current data and realities helped formulate the following general consensus by the CMOs regarding peritoneal dialysis:
- Patient and technique survival for PD patients by vintage continues to improve, despite the rapid uptake in home dialysis in part driven by the “bundle.”
- General consensus suggests that established provider infrastructure would support a home PD population of about 20% in the U.S.
- In a population health reimbursement model, PD may be economically preferable to achieve the value-based health care paradigm set forth by the Triple Aim (improved patient outcome, better care, and lower costs).
- There are unexpected hurdles beyond the providers’ control that are impeding the growth of PD penetration. These issues are further discussed below.
Clinical benefits of PD in the era of the bundled payment
CMS purposefully changed reimbursement for home therapies in the payment bundle to level the playing field and truly favor a financial infrastructure that would “encourage patient access to home dialysis.” 4 Given the financial incentive to grow home under the bundle, concerns were raised that this may result in an ill-prepared environment where patient outcomes could have suffered. However, five years later, data clearly show that such a concern was unfounded and that indeed the CMS intended increase in home penetration was met with favorable outcomes as well.
Despite a rapid uptick in utilization, the survival on PD vs in-center hemodialysis (CHD) by vintage continues to favor PD, further underlining the belief that PD is the preferred modality for incident patients requiring renal replacement therapy.
Provider infrastructure improving
To better serve patients, to optimize patient choice, and to improve overall clinical outcomes, dialysis providers have strengthened their abilities to provide home dialysis. They have done this by educating nursing staff, improving deployment of patient choice education initiatives, focusing on improving quality outcomes, and encouraging/facilitating physician education, especially education of renal fellows.
Dialysis providers have also increased the number of facilities that offer home dialysis training and care. However, it is recognized that while adding new small centers may facilitate growth in the numbers of patients on PD, these small centers may pose challenges in achieving quality outcomes. This is in part because some geographic regions have difficulty finding trained PD nurses. However, due to increased educational efforts this is less of an issue and to date, it does not appearthat the quality of care is a problem.
Physician education
As a group, the CMOs believe that innovations such as advancing telemedicine programs may further assure quality while building confidence and comfort for both physicians and patients to manage their kidney disease at home. In addition, initiatives by professional societies to provide home dialysis-specific education for physicians (i.e., International Society for Peritoneal Dialysis-sponsored “Home Dialysis University” for physicians and fellows in training; the American Society for Nephrology’s “Virtual Mentor Dialysis Curriculum,” the Forum of ESRD Network’s home dialysis toolkit) have increased.
As the number of patients with treated stage 5 kidney disease grows—partially due to better survival—our society will be challenged to provide services to all in need with the current approach.
Clearly the Institute for Healthcare Improvement’s paradigm of the Triple Aim—better outcome, improved patient experience, and sustainable costs––is more likely to be achieved by shifting patients to home dialysis rather than continuing to build dialysis facilities across the country. Canada, Australia, New Zealand, and other countries have lead the way with considerably higher home dialysis penetration for years. These are examples for the U.S. ESRD community to possibly emulate.
Population health issues
As health care systems are transformed from fee-for-service, volume-based reimbursement to a global, value-based system where providers are responsible not only for care, but also for clinical outcomes, patient satisfaction, and overall costs, home dialysis has an important role. PD patients tend to have fewer admissions/year than CHD patients, with the largest decrease seen in infection-related hospitalizations, resulting in lower annual costs to maintain a PD access than an HD access.5,6
Therefore, although the weekly reimbursement for dialysis is the same for PD and CHD, a study showed that, overall, PD remains less costly on a per patient per year basis than CHD ($69,919 vs $84,550 in 2013) when evaluating the total costs (the researchers did not evaluate for selection bias and its influence on cost).7 Importantly, the ability to live a meaningful and functioning life with home therapies allows a revival of the very essence of universal access to dialysis care as originally intended by the Medicare Act of 1973.
Unexpected hurdles/barriers
Barriers to the use of home therapies have long been recognized 8 and continue to exist on multiple levels, albeit in a mitigated way. These include patients, providers, physicians, facility infrastructure, lack of space in patients’ homes for supplies and, to some degree, reimbursement issues.9
The “bundle” has ameliorated a prior barrier that impeded the growth of PD. However, other past barriers and most unfortunately, new emerging ones, continue to prevent the clinically much desired higher PD penetration. Prolonged timelines to obtain state certifications continue to be a major barrier to developing home programs.
Some patients feel it is “safer” to have treatments in a medical setting rather than at home. Despite educational efforts and published data, some physicians remain uncomfortable with offering home dialysis and current monthly physician reimbursement for PD patient care hinders growth. In addition, the growing number of patients treated with PD requires additional nursing staff skilled in home modalities. While the nursing shortage is a challenge nationwide, it is an even bigger issue finding nurses experienced in home modalities.
Furthermore, other unexpected new barriers have emerged. One of the most pressing issues has included access to PD dialysate solutions, resulting in a rationing of automated peritoneal dialysis (APD) availability across the country. This has led to an unfortunate disenchantment of both patients and physicians to consider PD as a modality choice. Use of PD had been making a comeback, as reviewed above.
However, our observations are that the previously increasing trends of physician referrals to guide patients toward PD have plateaued and even decreased since Baxter Healthcare, the leading provider of PD solutions in the United States, announced in August 2014 that it would need to ration these solutions to all new patients (APD and CAPD) beginning in August 2014. Baxter is still rationing dialysate for APD while their CAPD solution is unconstrained. The reasons for this are multifactorial, but the end result is that this rationing of PD fluids created an upsetting barrier to all players – dialysis facilities, physicians, nurses, and patients.
Despite the ESRD community’s preparedness, educational efforts, interest, desire, and need, the ability to provide APD therapy, the most commonly desired modality choice among PD candidates, caused uncertainty for patients and caretakers and further complicated what would have otherwise resulted in the long-overdue growth for PD therapies in the U.S. To this date, the solution shortage and increased pricing are placing undue limitations to a therapy, which finally has matured in the US to the recognition and acceptance it had been denied far too long.
Summary
Home dialysis has been shown to offer patients the potential for improved clinical outcomes and better satisfaction with care. This is especially true for patients at the start of their ESRD lifetime. Recent changes in reimbursement that have moved to a bundled payment also favor the use of home dialysis. The CMOs have reviewed their collective experience and have seen a duplication of these observations despite a steep uptick in the use of home therapies. As a result, the CMOs have generally encouraged the use of home therapies within their respective organizations and as an industry, believe that about 20% of all dialysis patients can be placed successfully on PD (25% if home HD modalities are included). To promote its growth, the CMOs have developed various programs which have promoted infrastructure and education of patients, staff and physicians in the use and benefits of home therapies. It is believed that as reimbursement changes further, moving to a population health environment means that home therapies will provide even further value by reducing overall costs.
Recommendations
These efforts to provide PD to more patients within dialysis organizations continue. At the same time the government’s and CMS’ continued efforts to promote home will require new approaches to remove current and future barriers that are beyond provider control. In addition, at a time when PD product availability does not meet clinical need, we would ask the U.S. Food and Drug Administration to consider innovations in approval processes while maintaining patient safety and quality of new products.
References
- Mendelssohn DC, Mujais S, Soroka S, Brioullette J, Tokano T, Barre P, Mittal B, Singh A, Firanek C, Story K, Finkelstein FO. A prospective evaluation of renal replacement therapy modality eligibility. Nephrol Dial Transplant 24:555–561, 2009
- United States Renal Data System (USRDS), 2015 Annual Data Report: Epidemiology of Kidney Disease in the United States, available at https://www.usrds.org/2015/view/v2_01.aspx.
- Neumann M. The largest dialysis providers in 2016: Poised for change. Nephrology News and Issues 30 (8) 27, July 2016
- Federal Register, 8/12/2010, pages 49,030, 49,058
- USRDS 2015 Annual Data Report, Chapter 2, Fig. 5.1
- USRDS 2010 ADR, Vol. 2, Fig 11.18
- USRDS 2015 ADR Vol. 2 Chapter 11
- Golper TA, Saxena AB, Piraino B, et al. Systematic barriers to the effective delivery of home dialysis in the United States: A report from the Public Policy/Advocacy Committee of the North American Chapter of the International Society for Peritoneal Dialysis,” American Journal of Kidney Diseases 58 (6) pgs. 879–885, December 2011.
- Brill A. Economic benefits of increased home dialysis utilization and innovation. March 2016. http://static1.1.sqspcdn.com/static/f/460582/26886975/1456781059513/MGA+home+dialysis+paper+for+release.pdf?token=cfXmbqMBaTCw1q22XlaXoPbNICI%3D