The discovery of new drugs, diagnostics, and devices are typically viewed as innovations in the health care field. Implementation science (i.e., the science of applying research findings and evidence-based interventions to routine clinical practice) is less frequently recognized as a form of innovation. However, it plays a key role in evolving care by translating new techniques, protocols, and clinical insights into the field. While much has been written about the theory of implementation science, very few scientific articles have detailed its best practices in health care. Examples of effective program implementation include the National Institutes of Health’s Diabetes Prevention Program and Quit Line Program for tobacco cessation. Dialysis care also has improved significantly over the past century through implementation science, providing dialysis patients with broader access to care, improved outcomes, and a better overall experience.
NEJM Catalyst previously published an essay that criticized the U.S. dialysis sector for its lack of innovation. Our purpose here is to offer another viewpoint that highlights previous and ongoing advances in the delivery of safe and effective kidney care. We hope that our experience will inspire those in other sectors of health care to recognize innovation not only in new inventions, but also in the successful incorporation of new technologies and techniques into the delivery system.
Modern dialysis has existed only since World War II, when Willem J. Kolff, MD, created the first artificial kidney to remove the extra fluid and wastes that accumulate in the blood when the kidneys fail. Dialysis initially was scarce and was offered in only hospitals. Life-and-death committees held the responsibility of deciding who would receive lifesaving dialysis and who would not. Since then — with the launch of the Medicare End Stage Renal Disease (ESRD) program in 1973 (which provides near-universal insurance coverage for dialysis patients) and improved approaches to care through implementation science — dialysis has evolved from a hospital-based therapy to a safe, effective, and widely available outpatient procedure.
The two primary modalities of dialysis, hemodialysis and peritoneal dialysis, have saved thousands of lives. As of December 2015, approximately 495,000 people with kidney disease in the U.S. were receiving ongoing dialysis several times per week. Physicians, dialysis providers, payers, policymakers, and the kidney community at large are working to continue this trajectory of continuous improvement for patients.
Current Innovation: A Focus on Reducing Mortality
Once dialysis became broadly accessible, the kidney community’s focus shifted to reducing morbidity and mortality. As a result, the mortality rate among Medicare dialysis patients ≥65 years of age decreased from 30.9% in 2006 to 24.7% in 2016. This decrease is better than that associated with several other disease states.
Mortality rates associated with many conditions, including cancer, are often reduced through a focus on developing new drugs and devices. The pace of these developments has been more rapid in other sectors than it has in the dialysis sector; however, the kidney community has risen above its limitations in drug and device development by focusing on reducing mortality rates through implementation science — specifically, by leveraging data from the population, pragmatic clinical trials, and comprehensive disease registries to implement quality improvement activities on the domestic scale. Other health care sectors are now beginning to adopt similar techniques to improve outcomes.
Quality improvement activities in the kidney community have focused on clinical outcomes, which can directly affect mortality rates. On a fundamental level, dialysis must adequately remove wastes and fluids from the blood; thus, the effectiveness of dialysis is referred to as dialysis adequacy. As of 2016, 97.5% of patients undergoing hemodialysis were achieving the minimum standard for dialysis adequacy.
Dialysis also must involve efforts to avoid bloodstream infections in order to keep patients safe and out of the hospital. This goal can be accomplished, in part, by increasing the number of clinically appropriate patients in whom vascular access is achieved by means of an arteriovenous fistula (AVF) or arteriovenous graft rather than a central venous catheter (the latter of which is associated with a higher risk for infection). In 2003, the Centers for Medicare and Medicaid Services (CMS) launched Fistula First Catheter Last, dedicated to increasing the prevalence of AVF use in the United States. Between 2003 and 2015, the prevalence of AVF use grew from 32% to 60%.
Efforts also have been made to develop full-service pharmacies specializing in kidney care, which have had a positive impact on mortality. On average, dialysis patients consume 19 pills a day. Patient medication adherence has been reported to average just 50%, and lack of adherence has been reported to contribute to 25% of hospital readmissions. By making use of specialized integrated pharmacy services, dialysis patients can experience a 21% lower risk of mortality and spend 14% fewer days in the hospital. We believe that this integrated approach to medication management also could benefit patients in therapeutic areas other than kidney care.
Patients are particularly vulnerable to complications and mortality during their first year of dialysis. In 2009, Kidney Care Partners, representing most of the kidney community, launched a quality improvement campaign, Performance Excellence and Accountability in Kidney Care (PEAK), to address mortality rates during this period. Through collaboration with patients, clinicians, researchers, and other experts, Kidney Care Partners has launched quality improvement programs that have helped to decrease first-year mortality rates nationwide by approximately 25%.
The government also has invested in improving kidney care through implementation science. Over the last several years, CMS, in partnership with the kidney community, has pioneered several value-based care solutions that have helped to integrate care, improve results, and reduce costs related to dialysis. CMS efforts have included the following:
- 2006: Offered the first ESRD Chronic Condition Special Needs Plan (C-SNP), a Medicare Advantage plan that offers benefits specific to the unique needs of dialysis patients. Currently, there are 15 ESRD C-SNPs serving >5,000 patients.
- 2011: Bundled a more complete set of ESRD services for a fixed reimbursement, which has incentivized innovation.
- 2012: Launched the ESRD Quality Incentive Program (QIP), the first mandatory CMS pay-for-performance program. This program provides domestic quality benchmarks that have helped to guide continuous improvement in dialysis.
- 2013: Implemented the Five-Star Quality Rating System, a composite system that rates dialysis centers on the basis of clinical results. Overall program metrics have improved since the system’s inception, and, in particular, standardized mortality and infection ratios have significantly decreased.
- 2015: Established the first ESRD Seamless Care Organization (ESCO), a new payment and delivery system that focuses on patient-centered, high-quality care. The ESCOs have since generated considerable savings in the Medicare system. While ESCOs demonstrate potential, providers and CMS recognize and continue to address challenges possibly associated with scalability.
The Impact of Regulation on Innovation
While the kidney community has successfully reduced morbidity and mortality over the years, its ability to do so with new technologies has been constrained by regulatory mechanisms within the existing bundled payment system. Since the components and price of the current bundle were fixed with the bundle’s inception by CMS in 2011, there has been no incentive or mechanism to introduce new drugs or devices. This is true for both new (more expensive) replacements for existing components and new inventions.
CMS is attempting to address this issue through the 2018 final rule for the ESRD Prospective Payment System. This rule includes a transitional drug add-on payment adjustment for 2 years, which covers new pharmaceuticals outside of the bundle in order to encourage innovation and generate evidence. However, at the end of the 2 years, no incremental dollars will be added for pharmaceuticals already in the bundle, which may cause a barrier to innovation. CMS also has not yet determined a similar mechanism to account for devices in the bundle, which is a crucial issue given the high dependence on technology within the dialysis sector.
The Department of Health and Human Services also has acknowledged the constraints associated with the current bundled payment system and has implemented a number of programs to stimulate innovation in dialysis. These programs include the Kidney Health Initiative and the Kidney Innovation Accelerator (KidneyX) (both in partnership with the American Society of Nephrology) and the Fast Track program (through the Food and Drug Administration).
Future Opportunities for Innovation
Moving forward, the kidney community is aiming to continue reducing the impact of kidney disease on patients’ day-to-day activities and quality of life. Already, hemodialysis and peritoneal dialysis have evolved to accommodate varying patient lifestyles and preferences; for example, nocturnal in-center hemodialysis allows patients to undergo dialysis while sleeping, and home-based dialysis modalities (peritoneal dialysis and home hemodialysis) free patients from having to travel to the dialysis center multiple times per week. Peritoneal dialysis, although not an appropriate therapy for every dialysis patient, can offer greater lifestyle flexibility and better outcomes than in-center hemodialysis and has increased in prevalence across the U.S. by 26% since 2010.
Patients and caregivers can expect to see additional advances in the immediate future. First, a number of new hemodialysis technologies will be coming to the U.S. from Europe and Asia. These devices have the potential to offer biofeedback loops to prevent intradialytic hypotension, increase monitoring during dialysis treatment, and transfer data between the electronic medical record and the dialysis machine, thereby reducing the data collection burden and allowing for personalized dialysis prescriptions. User-friendly hemodialysis machines are being developed to give more patients the opportunity to experience the health benefits of hemodialysis at home. Efforts also have been made to develop a system that generates sterile peritoneal dialysis solution at home, eliminating the need to transport and store large bags of fluid. All of these innovations may allow for more personalized dialysis sessions, greater flexibility, and improved quality of life for patients.
One of the negative impacts of dialysis on patient quality of life involves the loss of autonomy associated with the need for the patient to remain confined to a chair or bed (overnight) at a dialysis clinic or at home to receive dialysis for several hours each week. To address this limitation, several efforts are underway to develop mobile artificial kidneys that mimic native kidneys by providing continuous dialysis. These devices can be either worn outside of the body or implanted. To date, a wearable hemodialysis machine has been clinically tested in humans in the U.S., and a wearable peritoneal dialysis machine is being developed in Asia.
In addition to improvements in dialysis, advances have been made in transplant immunosuppression and chain-based kidney donation, which have led to better outcomes following kidney transplants. Similarly, new drugs have demonstrated an effect on slowing of the progression of kidney disease to ESRD. Finally, given the richness of patient and machine data in dialysis, there have been a number of new advancements in predictive and prescriptive analytics, which allow care to be more effective and efficient.
Other health care sectors also may benefit from adopting elements of implementation science as a way to improve patient care. For the kidney community, the keys to success have included (1) collecting robust data through effective information technology, (2) paying meticulous attention to data definitions, and (3) creating a minimal data standard set for all patients. In addition, the aggregation of data at the facility level has allowed for performance transparency and the ability to conduct pragmatic clinical trials or pilots. Together, data collection and aggregation have been tremendously helpful in implementing dialysis in the outpatient setting and incorporating new research findings and technology into the care flow.
There is no doubt that much more can be done to create new drugs and devices to improve the lives of patients with advanced renal disease. However, through the efforts of the kidney community, dialysis has evolved from a scarcity to a globally common resource. Outcomes such as mortality, morbidity, and patient quality of life have improved with the incorporation of new technologies into existing health care systems. New ways of delivering dialysis, including at home and/or at night, have grown rapidly in the United States. Nascent efforts with wearable and implantable artificial kidneys have shown promise. As the kidney community continues to improve outcomes and reduce the burden of kidney disease through implementation science and innovation, efforts will be marked by a continued dedication to prioritizing safety, efficacy, and the individual needs of each patient.
The statements contained in this document are solely those of the authors and do not necessarily reflect the views or policies of CMS. The authors assume responsibility for the accuracy and completeness of the information contained in this document.