Next Steps on Kidney Care: Building on the Administration’s Initiative

Header kidneyhealth 01
Photo of ​Jacqueline Garry Lampert
​Jacqueline Garry Lampert
Visiting Fellow for Health Care
Photo of David Kendall
Senior Fellow for Health and Fiscal Policy

Like many end-stage renal disease patients, Michael doesn’t have many good options apart from the in-center dialysis keeping him alive for the past several years.1 As his chronic kidney disease progressed, he didn’t know he had it, and once he found out, he didn’t get the medical support to prevent or at least slow, the disease. When he faced the prospect of dialysis, he was not fully aware of home dialysis. In retrospect, he’s still not sure he could have chosen it, given the demands it places on patients and their caregivers, but he regrets not considering it seriously because it would have made a transplant more likely. Now, the COVID-19 pandemic has made him feel even more vulnerable as his health deteriorates. Like thousands of end-stage renal disease patients, Michael can no longer get a kidney transplant.

The health care system has failed Michael and so many patients like him with chronic kidney disease or end-stage renal disease. This is in large part due to the failure to identify chronic kidney disease early, educate patients about the disease and their treatment options, and engage in shared decision-making to help patients make informed treatment choices. When prevention fails, the best treatment is a kidney transplant, but nearly 95,000 Americans are waiting for one. The situation is not helped by the isolation of end-stage renal disease patients in traditional, fee-for-service Medicare, which does not excel at the kind of disease management, care coordination, and transplant preparation that improve the lives of patients like Michael.

Last year, the Trump Administration launched a kidney health initiative, which has created a historic opportunity to improve care for patients like Michael. It calls for a dramatic increase in transplants and home dialysis. The President’s July 10, 2019 executive order and recent agency initiatives have come as Medicare Advantage enrollment is opening up for patients with end-stage renal disease in 2021. In addition, Congress is considering several bills related to kidney health. To keep the ball rolling, Congress and the Administration need to take three steps to improve kidney care for all patients:

  1. Incentivize early disease identification, patient education, and shared decision-making.
  2. Provide care management across all forms of coverage.
  3. Promote kidney transplantation.

This report provides the key facts about kidney disease and treatment as it stands today and shows how to improve kidney care going forward.  

What is Kidney Disease, How Should it be Treated, and Why is Care Falling Short?

End-stage renal disease is the final stage (stage 5) of chronic kidney disease. This occurs when the kidneys can no longer remove enough waste and excess water from the body to support daily living. Patients also face complications like nerve damage, infections, weak bones, and pain in joints, muscles, and bones. Chronic kidney disease is most commonly caused by diabetes and high blood pressure (hypertension).2 Despite these known risk factors, primary care physicians do not consistently screen for it.3 Even when it is diagnosed, the majority of patients receive no specialty care from a nephrologist before starting dialysis.4 As a result, many patients “crash into” dialysis following a trip to the emergency room and face a greater risk of complications and death, as well as lower quality of life.5

Patients with end-stage renal disease do not have many treatment options—without a kidney transplant or dialysis, they will likely die rapidly.6 Their best option is a transplant, which offers longer survival, better quality of life, and lower health care costs.7 In 2018, 21,167 Americans received kidney transplants, yet nearly 95,000 were waiting for a transplant, with an average wait of four years.8 Only about 14% of new dialysis patients join the transplant waiting list each year and in 2018, 4,000 people died waiting for a kidney transplant and another 4,400 became too sick to receive one, like Michael.9

Patients waiting or ineligible for a kidney transplant face a complicated choice about their dialysis care. They can choose to go to a hemodialysis center about three times per week for a 3-5 hour-visit where a machine filters their blood.10 Many also have the option of in-home dialysis. Despite more convenience and improved quality of life with home dialysis, however, only 12% of patients end up using it.11 In-home dialysis involves another choice: hemodialysis or peritoneal dialysis. In-home hemodialysis uses a machine to filter the blood like in-center hemodialysis. Peritoneal dialysis, which 85% of home dialysis patients use, involves sending a cleansing fluid through a tube into the thin membrane lining the inside of the stomach (the peritoneum) to soak up waste and then draining the fluid to remove the waste.12

Each treatment choice has varying health benefits, flexibility, personal training, site requirements, and support needs.13 For example, home dialysis may be clinically appropriate for approximately half of all end-stage renal disease patients, but the percentage of patient who could “realistically” be expected to dialyze at home may be lower due to other factors, including patient preference. Patients need clear, objective information to make a choice in consultation with their doctor.

Patients are much more likely to select home dialysis if they receive information about their options before starting treatment.14 With many patients crashing into dialysis, they do not have a chance to choose the kind of dialysis they prefer and many default to using in-center hemodialysis.15 But when given information about their options before starting treatment, patients are much more likely to select home dialysis.16 In fact, patients who are fully educated on their options will select home dialysis almost as often as in-center dialysis.17 Pre-dialysis education and patient decision aids, when properly used, are also associated with reduced emergency dialysis initiation, increased dialysis-free time, increased likelihood of patients staying employed, increased survival, and reduced anxiety and fear.18 Perhaps if Michael had received more information and earlier education, he might have selected home dialysis when the need arose and received the necessary support to stay healthy enough for a kidney transplant.

Current kidney care is unacceptable. The President’s Executive Order on Advancing American Kidney Health calls the state of care for patients with chronic kidney disease and end-stage renal disease like Michael “unacceptable:”19 

“…too many at-risk patients progress to late-stage kidney failure; the mortality rate is too high; current treatment options are expensive and do not produce an acceptable quality of life; and there are not enough kidneys donated to meet the current demand for transplants.”20

The order calls for the biggest change to kidney care since 1972 when Congress extended Medicare coverage to patients with end-stage renal disease regardless of their age. It builds on a 2018 Progressive Policy Institute report to reform the treatment of kidney disease.21

To start, the US Department of Health and Human Services (HHS) has set a big, audacious goal as a way to disrupt the kidney health care system, which is long overdue for an overhaul. In 2025, 80% of new end-stage renal disease patients should either receive home dialysis or a kidney transplant.22 That is ambitious because the 2017 transplant rate for patients newly diagnosed with end-stage renal disease was 3% and home dialysis use was 11%.23 That is a total of 14%, which is a long way from HHS’ goal.

Current trends will make achieving that goal difficult. In 2009, the transplant rate for newly-diagnosed patients increased by just 12%. While the use of home dialysis has some momentum with an increase of 64% over the same period, that rate of increase will have to accelerate dramatically to meet the HHS goal by 2025.24

What Can Congress and the Administration do to Improve Kidney Care?

Given the extraordinary interest in kidney care, the Administration and Congress can make dramatic improvements so Americans can avoid end-stage renal disease and when they don’t, they can make informed treatment and coverage decisions. To do that, the Administration and Congress need to work together on three fronts: 

1. Incentivize early disease identification, patient education, and shared decision-making.

Like Michael, 90% of the 37 million adults in the United States with chronic kidney disease are not aware they have it.25 Moreover, half of adults with failing kidneys are not aware of it. Just as bad is that research has not kept up to determine effective screening methods.26 The President’s kidney initiative calls for incentives to prevent kidney failure, but the Administration has only developed a general approach for solving the problem.27Below are three specific steps that can help.

Early disease identification. Lack of awareness of the disease and prevention hits certain groups of Americans harder than others. African Americans, Latinos, and men are more likely to develop end-stage renal disease.28 African Americans are especially vulnerable and face more challenges in receiving effective prevention, access to optimal care including home dialysis, and transplants.29

HHS should focus payment models toward much earlier stages of chronic kidney disease, where patients and clinicians may have greater success in stopping or slowing disease progression and educating patients to make informed treatment choices.30 HHS has begun to take these steps in the Kidney Care Choices Model, a voluntary payment model consisting of two contracting options that include beneficiaries with stage 4 or stage 5 chronic kidney disease, with the aim of delaying or avoiding dialysis.31 This model could attract the broad participation of nephrologists if HHS addresses many practical considerations like the impact of COVID-19 as well as pre-pandemic concerns like practice size requirements and reimbursement levels.32

Yet even this may not be early enough in the disease progression to have a meaningful impact on patient outcomes. To identify patients at even earlier stages, HHS could use, or incentivize providers and health plans to use, data analytics to identify patients with chronic kidney disease as some are already doing.33 HHS could also incentivize primary care physicians to screen for chronic kidney disease with an extra incentive to support reductions in racial and other socio-economic disparities. Hypertension and diabetes are major risk factors for chronic kidney disease, yet 60% of Medicare beneficiaries diagnosed with diabetes and 93% diagnosed with hypertension are not screened for kidney damage with simple blood and urine tests.34 Additional research on screening techniques could identify patients at earlier disease stages, increase co-management by nephrologists (with associated outcome improvements described above), and increase opportunities for patient education and shared decision-making about treatment choices.

Patient Education. One example of patient education is the Kidney Disease Education benefit, which provides information about therapy choices and the management of comorbidities to help delay the need for dialysis.35 Unfortunately, less than 2% of Medicare beneficiaries eligible for the Kidney Disease Education benefit receive it.36 CMS’ End-Stage Renal Disease Treatment Choices model would expand the types of practitioners permitted to provide the benefit and expand eligibility to beneficiaries with stage 4 chronic kidney disease and some beneficiaries with end-stage renal disease.37 While this is certainly helpful, Congress and CMS should make the benefit available to patients at much earlier stages of chronic kidney disease, not just Stage 4, improve funding for it, and permit all qualified providers like registered nurses to offer it.38In addition, all types of providers should be allowed to refer patients to the program as the Chronic Kidney Disease Improvement in Research and Treatment Act proposes.39

Shared decision-making. A key measure of quality kidney disease treatment is whether patients are fully informed of their treatment options, which involves using a shared decision-making process and respecting patient choice. Rather than incentivizing providers to direct patients into a particular treatment modality, as the End-Stage Renal Disease Treatment Choices model proposes, HHS should incentivize providers to effectively administer patient education and shared decision-making tools and reward providers whose patients demonstrate a full understanding of their disease and treatment options as proposed in the Chronic Kidney Disease Improvement in Research and Treatment Act.40

In addition, HHS should measure patient experiences and satisfaction with their treatment choice. While in-center dialysis patients are surveyed on their experience, a similar survey for home dialysis patients does not exist. The Medicare Payment Advisory Commission (MedPAC) and members of Congress have called on HHS to create such a survey.41

2. Provide care management across all forms of coverage to counteract wasteful practices.

Patients like Michael who are lucky enough to find out in time about their kidney disease often do not know how to manage their condition and do not get the right care. For example, in 2015, more than 35% of Medicare patients with later-stage chronic kidney disease (stage 4 or 5) did not see a nephrologist following their diagnosis.42 Once they are on dialysis, the rest of their health care needs often go unmanaged and those health problems create obstacles to obtaining a transplant.43 Care management is the key to making sure every patient gets the right kidney care and all other types of care they need and is especially important during the COVID-19 crisis because of disruptions in care. Below are four ways to promote care management.

Incentives for care management. HHS has finalized testing of a new End-Stage Renal Disease Treatment Choices model and mandated the participation of 30% of Medicare end-stage renal disease patients and their providers, which is down from the 50% in the original proposal.44 One element of this model is a positive or negative payment adjustment based on providers’ home dialysis rate and transplant rate.45 The proposed version generated many concerns. Seventy-four members of Congress have requested several changes to the model prior to implementation.46 The Medicare Payment Advisory Commission (MedPAC) has expressed “significant methodological concerns” with the proposed measurement of home dialysis and transplant rates and believes CMS should not implement the model.47 Instead, they recommend the development of new ways to incentivize providers to care for the whole patient, which is also known as care management. It is important to incentivize a comprehensive approach to each patient’s care not just specific goals. Nonetheless, the Administration announced this new model will start on January 1, 2021.48

Access to care management. Patients should have access to care management regardless of where they get their coverage. Care management might have made a real difference for Michael, keeping him healthy enough to stay on the transplant waitlist and eventually receive a kidney transplant. Today, nearly all beneficiaries entitled to Medicare due to an end-stage renal disease diagnosis are enrolled in fee-for-service Medicare. Only about 15% of all such beneficiaries have coverage through a Medicare Advantage plan, which often provides care management services. Medicare beneficiaries with end-stage renal disease have been allowed to stay in a Medicare Advantage plan if they develop the disease after enrollment.49 Starting in 2021, Medicare Advantage plans will be open to any Medicare beneficiary with end-stage renal disease.50 This opportunity, combined with the Trump Administration’s executive order directing HHS to strengthen the Medicare Advantage program to expand the availability and affordability of plan options, should help more kidney disease patients receive coordinated, chronic care management.51 As part of that effort, HHS will have to monitor payments to Medicare Advantage plans to ensure they are sufficient to cover the higher health care costs of patients with end-stage renal disease.52

Patients who wish to remain in fee-for-service Medicare should have a choice of designated provider groups that offer whole patient care as well as kidney care management. Congress could create such an option through the BETTER Kidney Care Act that does not duplicate the new coverage that will be available through Medicare Advantage.53 Another source of modifications is MedPAC’s proposal for a shared savings program that would expand management and coordination of care using savings from reduced hospitalizations.54 Lastly, lawmakers need to consider the new voluntary model payments to prevent confusion and duplication.55

Patient assistance in choosing care management. Between Medicare Advantage and new care management options in fee-for-service Medicare, kidney care patients will have many options that will likely cause confusion. They should be able to choose from among a variety of plans with full protections and information about their choices. HHS should create a Medicare Plan Finder tool specifically designed for people with chronic kidney disease to help them make comparisons and choose the plan that is right for them. That tool currently helps all Medicare beneficiaries choose among public and private health plans to complete their coverage.

Removing regulatory obstacles to care management. Congress and HHS should provide limited waivers to the Stark Law and anti-kickback statute for care management. Those laws prevent providers and medical manufacturers from profiting from referrals and payments in return for the use of a specific product or service, but they can also create legal obstacles to coordinating and providing the right care. The waivers would give nephrologists, dialysis providers, and others involved in kidney care the flexibility and accountability under value-based payment arrangements to improve care coordination, provide supplemental services, and lower costs for kidney disease patients.56 HHS proposed two rules in October 2019 that aim to achieve these goals.57

3. Promote kidney transplantation.

Given the superior outcomes from a kidney transplantation compared to dialysis, fully informed patients are likely to choose this treatment option. But nearly 95,000 Americans are on the kidney transplant waitlist. Those who do get a transplant face a host of additional problems including the loss of Medicare coverage for immunosuppressive drugs three years after a transplant. HHS and Congress must advance policies that promote and expand kidney transplantation.

The President’s executive order directs HHS to revise rules and metrics governing organ procurement organizations to evaluate their performance and to improve kidney matching and delivery so that fewer donated kidneys are discarded.  Current regulations governing organ procurement organizations allow for self-reporting and self-interpreting of outcomes data, perpetuating a system that fails to hold these entities accountable for their performance. Even entities that recover less than one-third of organs from potential donors have never lost their government contracts; in fact, no organ procurement organization has been decertified for poor performance in the last 20 years. 

The executive order is a good start for improving kidney transplantation. Here are three additional actions that Congress and the Administration can take:

Promoting kidney donations. Congress should pass the Living Donor Protection Act, which would provide protections to living organ donors and promote organ donation.58 Promoting living donation is critically important given the minimal effectiveness of past efforts to increase kidney transplants from deceased donors.59 Legislative and regulatory efforts to hold organ procurement organizations accountable for increasing the supply of usable kidneys and reducing the number of donated kidneys that are discarded would help to increase deceased donor transplants.60

Extended coverage for immunosuppressive drugs. Congress should pass legislation to extend coverage of immunosuppressive drugs for kidney transplant recipients.61 A recent HHS study found that extending Medicare coverage of immunosuppressive drugs for the patient’s lifetime would save Medicare $73 million over 10 years.62

Accountability for patients’ transplant readiness. As called for by members of Congress, HHS should modify the mandatory End-Stage Renal Disease Treatment Choices model to not hold providers accountable for increasing transplant rates until organ procurement organizations increase the supply of transplantable organs.63 While HHS modified the final rule for the model to focus more on patient readiness to be listed for a kidney transplant, it should consider additional adjustments as the model moves forward in the provision that holds providers accountable for the supply of kidneys.

Conclusion

Medicare’s coverage of end-stage renal disease has gone from a life-saving public program with little innovation and limited private sector involvement to the promise of federal leadership working in concert with a diverse range of stakeholders. The Trump Administration has focused unprecedented attention on improving care and quality of life for Americans with chronic kidney disease and end-stage renal disease. To further advance this effort, the Administration and Congress should enact policies that prioritize early disease identification, patient education and shared decision-making, promote care coordination and disease management, and promote kidney transplantation. With such policies, kidney care can truly fulfill its potential for all patients and the Administration will achieve its aim of increasing home dialysis and kidney transplantation.

Endnotes

  1. Michael’s story is fictional to help illustrate the disease pathway of many end-stage renal disease patients.

  2. United States, Department of Health and Human Services, National Institutes of Health, National Library of Medicine. "End-stage kidney disease." MedlinePlus, 16 Jan. 2018, www.nlm.nih.gov/medlineplus/ency/article/000500.htm. Accessed 28 Oct. 2019.

  3. Allen, Adrienne S., et al. "Primary Care Management of Chronic Kidney Disease." Journal of General Internal Medicine, Apr. 2011, www.ncbi.nlm.nih.gov/pmc/articles/PMC3055964/. Accessed 22 Nov. 2019.

  4. Fischer, Michael J. et al. "Predialysis Nephrology Care and Dialysis-Related Health Outcomes Among Older Adults Initiating Dialysis." BMC Nephrology, 29 July 2016, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4966864/. Accessed 28 Oct. 2019.

  5. Molnar, Amber O. et al. “Risk Factors for Unplanned and Crash Dialysis Starts: A Protocol for a Systematic Review and Meta-Analysis.” BMC Systematic Reviews, 19 July 2016, www.ncbi.nlm.nih.gov/pmc/articles/PMC4950106/. Accessed 17 Mar. 2019. See also Hassan, Rana et al. “Risk Factors for Unplanned Dialysis Initiation: A Systematic Review of the Literature.” Canadian Journal of Kidney Health and Disease, 13 Mar. 2019, www.ncbi.nlm.nih.gov/pmc/articles/PMC6419254/. Accessed 17 Mar. 2019.

  6. Abbsi, Maaz, Glenn Chertow, and Yoshio Hall. "End-stage Renal Disease." Clinical Evidence Handbook, BMJ Publishing Group, 15 Dec. 2010, www.aafp.org/afp/2010/1215/p1512.html. Accessed 22 Nov. 2019.  

  7. “US Renal Data System 2018 Annual Data Report: Epidemiology of Kidney Disease in the United States,” United States Renal Data System, 2018, Volume 2, Chapter 6, www.usrds.org/2018/view/v2_06.aspx. Accessed 26 Nov. 2019.

  8. United States, Department of Health and Human Services, Organ Procurement and Transplantation Network, National Data. Accessed 28 Oct. 2019. Available at: https://optn.transplant.hrsa.gov/data/view-data-reports/national-data/.

  9. United States, Department of Health and Human Services, Organ Procurement and Transplantation Network, National Data. Accessed 28 Oct. 2019. Available at: https://optn.transplant.hrsa.gov/data/view-data-reports/national-data/.

  10. United States, Congress, Medicare Payment Advisory Commission. “Health Care Spending and the Medicare Program.” Data Book, p. 185, June 2017. Accessed October 28, 2019. Available at: http://www.medpac.gov/-documents-/data-book; See also United States, Congress, Medicare Payment Advisory Commission, “Health Care Spending and the Medicare Program,” Data Book, June 2015, p. 185, www.medpac.gov/-documents-/data-book. Accessed 28 Oct. 2019.

  11. “US Renal Data System 2019 Annual Data Report: Epidemiology of Kidney Disease in the United States.” United States Renal Data System, 2019, Volume 2, reference table D-1, https://usrds.org/reference.aspx. Accessed 26 Nov. 2019.

  12. United States, Department of Health and Human Services, National Institutes of Health, National Institute of Diabetes and Digestives and Kidney Diseases. “Kidney Failure: Choosing a Treatment That’s Right for You.” Jan. 2018, www.niddk.nih.gov/health-information/health-topics/kidney-disease/kidney-failure-choosing-a-treatment-thats-right-for-you/Pages/facts.aspx. Accessed 28 Oct. 2019. See also “Peritoneal Dialysis: What You Need to Know.” National Kidney Foundation, www.kidney.org/atoz/content/peritoneal. Accessed 28 Oct. 2019.

  13. United States, Congress, MedPAC. “March 2020 Report to the Congress: Medicare Payment Policy.” 13 Mar. 2020, p. 198, http://www.medpac.gov/docs/default-source/reports/mar20_entirereport_sec.pdf. Accessed 16 Apr. 2020.

  14. Kutner, Nancy G. et al. "Patient Awareness and Initiation of Peritoneal Dialysis." Archives of Internal Medicine, 24 Jan. 2011, jamanetwork.com/journals/jamainternalmedicine/article-abstract/226445. Accessed 28 Oct. 2019.

  15. Molnar, Amber O. et al. “Risk Factors for Unplanned and Crash Dialysis Starts: A Protocol for a Systematic Review and Meta-Analysis.” BMC Systematic Reviews, 19 July 2016, www.ncbi.nlm.nih.gov/pmc/articles/PMC4950106/. Accessed 17 Mar. 2019. See also Hassan, Rana et al. “Risk Factors for Unplanned Dialysis Initiation: A Systematic Review of the Literature.” Canadian Journal of Kidney Health and Disease, 13 Mar. 2019, www.ncbi.nlm.nih.gov/pmc/articles/PMC6419254/. Accessed 17 Mar. 2019.

  16. Kutner, Nancy G. et al. "Patient Awareness and Initiation of Peritoneal Dialysis." Archives of Internal Medicine, 24 Jan. 2011, jamanetwork.com/journals/jamainternalmedicine/article-abstract/226445. Accessed 28 Oct. 2019.

  17. Lacson, Eduardo et al. “Effects of a Nationwide Predialysis Educational Program on Modality Choice, Vascular Access, and Patient Outcomes.” American Journal of Kidney Diseases, Aug. 2011, www.ajkd.org/article/S0272-6386(11)00808-0/fulltext. Accessed 28 October 2019.

  18. Cassidy, Brendan P. et al. "Barriers to Education and Shared Decision Making in the Chronic Kidney Disease Population: A Narrative Review." Canadian Journal of Kidney Health and Disease," 2 Nov. 2018, www.ncbi.nlm.nih.gov/pmc/articles/PMC6236635/#bibr79-2054358118803322. Accessed 28 Oct. 2019.

  19. United States, Executive Office of the President, Donald Trump. "Executive Order on Advancing Kidney Health." 10 July 2019, www.whitehouse.gov/presidential-actions/executive-order-advancing-american-kidney-health/. Accessed 28 Oct. 2019.

  20. United States, Executive Office of the President, Donald Trump. "Executive Order on Advancing Kidney Health." 10 July 2019, www.whitehouse.gov/presidential-actions/executive-order-advancing-american-kidney-health/. Accessed 28 Oct. 2019.

  21. Kim, Anne and Arielle Kane. "Reforming the Treatment of Kidney Disease," Policy Memo, Progressive Policy Institute, 25 Apr. 2018, www.progressivepolicy.org/publications/policy-memo/reforming-the-treatment-of-kidney-disease/. Accessed 28 Oct. 2019.

  22. United States, Department of Health and Human Services. "HHS Launches President Trump's 'Advancing American Kidney Health' Initiative," Press Release, 10 July 2019, www.hhs.gov/about/news/2019/07/10/hhs-launches-president-trump-advancing-american-kidney-health-initiative.html. Accessed 28 October 2019.

  23. “US Renal Data System 2019 Annual Data Report: Epidemiology of Kidney Disease in the United States.” United States Renal Data System, 2019, Volume 2, reference table D-1, https://usrds.org/reference.aspx. Accessed 26 Nov. 2019.

  24. “US Renal Data System 2019 Annual Data Report: Epidemiology of Kidney Disease in the United States.” United States Renal Data System, 2019, Volume 2, reference table D-1, https://usrds.org/reference.aspx. Accessed 26 Nov. 2019.

  25. United States, Department of Health and Human Services, Centers for Disease Control and Prevention. "Chronic Kidney Disease in the United States, 2019." 11 Mar. 2019, www.cdc.gov/kidneydisease/publications-resources/2019-national-facts.html. Accessed 22 Nov. 2019.

  26. "Screening for Chronic Kidney Disease: Recommendation Statement." U.S. Preventive Services Task Force. American Family Physician, 15 Feb. 2014, www.aafp.org/afp/2014/0215/od1.html. Accessed 22 Nov. 2019.

  27. United States, Department of Health and Human Services, Office of the Assistant Secretary for Planning and Evaluation. "Advancing American Kidney Health." 10 July 2019, pp. 9-10, https://aspe.hhs.gov/pdf-report/advancing-american-kidney-health. Accessed 28 October 2019.

  28. United States, Department of Health and Human Services, Centers for Disease Control and Prevention. "Chronic Kidney Disease in the United States, 2019." 11 Mar. 2019, www.cdc.gov/kidneydisease/publications-resources/2019-national-facts.html. Accessed 22 Nov. 2019.

  29. Assari, Shervin. "Racial disparities in chronic kidney diseases in the United States; a pressing public health challenge with social, behavioral and medical causes." Journal of Nephropharmacology, 12 Dec. 2015, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5297505/. Accessed 22 Nov. 2019; See also Nicholas, Susanne, Kamyar Kalantar-Zadeh, and Keith C. Norris. "Racial Disparities in Kidney Disease Outcomes." Seminars in Nephrology, Sept. 2013, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3983362/. Accessed 22 Nov. 2019; See also Turenne, Marc et al. “Payment Reform and Health Disparities: Changes in Dialysis Modality under the New Medicare Dialysis Payment System.” Health Services Research, 30 May 2018, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5980208/. Accessed 3 Dec. 2019.

  30. United States, Congress, MedPAC. “March 2020 Report to the Congress: Medicare Payment Policy.” 13 Mar. 2020, p. 173, http://www.medpac.gov/docs/default-source/reports/mar20_entirereport_sec.pdf. Accessed 16 Apr. 2020.

  31. United States, Department of Health and Human Services, Centers for Medicare & Medicaid Services. "Kidney Care First (KCF) and Comprehensive Kidney Care Contracting (CKCC) Models." Fact Sheet, 10 July 2019. Accessed 10 Nov. 2019, www.cms.gov/newsroom/fact-sheets/kidney-care-first-kcf-and-comprehensive-kidney-care-contracting-ckcc-models. Accessed 28 Oct. 2019.

  32. Perlmutter, Jeffrey. “RPA's Input on Kidney Care First Request for Applications.” Letter to Amy Bassano, Acting Director, Center for Medicare and Medicaid Innovation, Renal Physicians Association, 9 Dec.2019, www.renalmd.org/news/480984/RPAs-Input-on-Kidney-Care-First-Request-for-Applications.htm. Accessed 14 Feb. 2020.

  33. "CVS Kidney Care." CVS, https://cvshealth.com/about/our-offerings/cvs-kidney-care. Accessed 10 Nov. 2019.

  34. United States, Department of Health and Human Services, Office of the Assistant Secretary for Planning and Evaluation. "Advancing American Kidney Health." 10 July 2019, pp. 9-10, https://aspe.hhs.gov/pdf-report/advancing-american-kidney-health. Accessed 28 October 2019.

  35. United States, Government Accountability Office. "End-Stage Renal Disease: Medicare Payment Refinements Could Promote Increased Use of Home Dialysis." Report to the Subcommittee on Health, Committee on Ways and Means, House of Representatives, 15 Oct. 2015, p. 10, www.gao.gov/assets/680/673140.pdf. Accessed 28 Oct. 2019.

  36. United States, Government Accountability Office. "End-Stage Renal Disease: Medicare Payment Refinements Could Promote Increased Use of Home Dialysis." Report to the Subcommittee on Health, Committee on Ways and Means, House of Representatives, 15 Oct. 2015, p. 1, www.gao.gov/assets/680/673140.pdf. Accessed 28 Oct. 2019.

  37. United States, Department of Health and Human Services, Centers for Medicare & Medicaid Services. "Medicare Program; Specialty Care Models to Improve Quality of Care and Reduce Expenditures." Final Rule, 29 Sep. 2020, p. 61114, www.federalregister.gov/documents/2020/09/29/2020-20907/medicare-program-specialty-care-models-to-improve-quality-of-care-and-reduce-expenditures. Accessed 12 Oct. 2020.

  38. United States, Government Accountability Office. "End-Stage Renal Disease: Medicare Payment Refinements Could Promote Increased Use of Home Dialysis." Report to the Subcommittee on Health, Committee on Ways and Means, House of Representatives, 15 Oct. 2015, p. 4, www.gao.gov/assets/680/673140.pdf. Accessed 28 Oct. 2019.

  39. United States, Congress, Senate. " S.1676—Chronic Kidney Disease Improvement in Research and Treatment Act of 2019.” 116th Congress, 1st Session, 23 May 2019, www.congress.gov/bill/116th-congress/senate-bill/1676/. Accessed 12 Oct. 2020. See also United States, Congress, House of Representatives. "H.R. 3912—Chronic Kidney Disease Improvement in Research and Treatment Act.” 116th Congress, 1st Session, 23 Jul. 2019, www.congress.gov/bill/116th-congress/house-bill/1224. Accessed 12 Oct. 2020.

  40. United States, Congress, Senate. " S.1676—Chronic Kidney Disease Improvement in Research and Treatment Act of 2019.” 116th Congress, 1st Session, 23 May 2019, www.congress.gov/bill/116th-congress/senate-bill/1676/. Accessed 12 Oct. 2020. See also United States, Congress, House of Representatives. "H.R. 3912—Chronic Kidney Disease Improvement in Research and Treatment Act.” 116th Congress, 1st Session, 23 Jul. 2019, www.congress.gov/bill/116th-congress/house-bill/1224. Accessed 12 Oct. 2020; Kendall, David and Elizabeth Quill. “Medical Discussion Guides: Less Confusion, Better Decisions for Patients.” Report, Third Way, 5 Mar. 2015, www.thirdway.org/report/medical-discussion-guides-less-confusion-better-decisions-for-patients. Accessed 17 Mar. 2020.

  41. Crosson, Francis J. "Medicare Program; Specialty Care Models to Improve Quality of Care and Reduce Expenditures." Comment Letter to CMS, 3 Sep. 2019, www.medpac.gov/docs/default-source/comment-letters/09032019_specialtycaremodels_medpac_comment_v2_sec.pdf?sfvrsn=0. Accessed 28 Oct. 2019. See also United States, Congress, House of Representatives. "Letter to Secretary Azar and Administrator Verma on the Proposed ESRD Treatment Choices (ETC) mandatory demonstration." 17 Oct. 2019, https://kidneycarepartners.com/wp-content/uploads/2019/10/ETC-Kidney-Model-FINAL-SIGNED.pdf. Accessed 28 Oct. 2019.

  42. “US Renal Data System 2018 Annual Data Report: Epidemiology of Kidney Disease in the United States,” United States Renal Data System, 2018, Volume 2, Chapter 2, p. 43, www.usrds.org/2018/view/v2_06.aspx. Accessed 26 Nov. 2019.

  43. "Kidney Transplant Toolkit." Forum of ESRD Networks’ Medical Advisory Council, 2019, https://esrdnetworks.org/resources/toolkits/mac-toolkits-1/new-kidney-transplant-toolkit. Accessed 27 Nov. 2019.

  44. Brady, Michael. “CMS approves chronic kidney disease payment model.” Modern Healthcare, 18 Sep. 2020, www.modernhealthcare.com/payment/cms-approves-chronic-kidney-disease-payment-model. Accessed 9 Oct. 2002.

  45. United States, Department of Health and Human Services, Centers for Medicare & Medicaid Services. "Proposed End-Stage Renal Disease Treatment Choices (ETC) Mandatory Model." Fact Sheet, 10 July 2019, www.cms.gov/newsroom/fact-sheets/proposed-end-stage-renal-disease-treatment-choices-etc-mandatory-model. Accessed 28 Oct. 2019.

  46. United States, Congress, House of Representatives. "Letter to Secretary Azar and Administrator Verma on the Proposed ESRD Treatment Choices (ETC) Mandatory Demonstration." 17 Oct. 2019, https://kidneycarepartners.com/wp-content/uploads/2019/10/ETC-Kidney-Model-FINAL-SIGNED.pdf. Accessed 28 Oct. 2019.

  47. Crosson, Francis J. "Medicare Program; Specialty Care Models to Improve Quality of Care and Reduce Expenditures." Comment Letter to CMS, 3 Sep. 2019, www.medpac.gov/docs/default-source/comment-letters/09032019_specialtycaremodels_medpac_comment_v2_sec.pdf?sfvrsn=0. Accessed 28 Oct. 2019.

  48. Brady, Michael. “CMS approves chronic kidney disease payment model.” Modern Healthcare, 18 Sep. 2020, https://www.modernhealthcare.com/payment/cms-approves-chronic-kidney-disease-payment-model. Accessed 12 Oct. 2020.

  49. United States, Congress, Medicare Payment Advisory Commission. “Health Care Spending and the Medicare Program.” Data Book, June 2017, p. 185, www.medpac.gov/-documents-/data-book. Accessed 28 Oct. 2019. See also United States, Congress, Medicare Payment Advisory Commission. “Medicare Payment Policy.” Report to the Congress, Mar. 2016, p. 152, http://www.medpac.gov/-documents-/reports. Accessed 28 Oct. 2019.

  50. United States, Congress, House of Representatives, “P.L. 114-255— 21st Century Cures Act.” 114th Congress, 2nd Session, 13 Dec. 2016, www.congress.gov/bill/114th-congress/house-bill/34. Accessed 28 Oct. 2019.

  51. United States, Executive Office of the President, Donald Trump. "Executive Order on Protecting and Improving Medicare for Our Nation's Seniors." 3 Oct. 2019, www.whitehouse.gov/presidential-actions/executive-order-protecting-improving-medicare-nations-seniors/. Accessed 28 Oct. 2019.

  52. Courtney, Tim and Rachel Stewart. “Increased ESRD Beneficiary Enrollment Flexibility Presents a Potential Financial Challenge for Medicare Advantage Plans in 2021.” Wakely, January 2019, https://tinyurl.com/y5p82qa9; See also “Analysis of End-Stage Renal Disease Payment Adequacy in Medicare Advantage.” Better Medicare Alliance. Dec. 2019, www.bettermedicarealliance.org/policy-research/resource-library/analysis-end-stage-renal-disease-payment-adequacy-medicare. Accessed 3 Jan. 2020.

  53. United States, Congress, House of Representatives,H.R, 8254—BETTER Kidney Care Act. 116th Congress, 2nd Session, 15 Sep. 2020, https://www.congress.gov/bill/116th-congress/house-bill/8254. Accessed 13 Oct. 2020.

  54. Crosson, Francis J. "Medicare Program; Specialty Care Models to Improve Quality of Care and Reduce Expenditures." Comment Letter to CMS, 3 Sep. 2019, www.medpac.gov/docs/default-source/comment-letters/09032019_specialtycaremodels_medpac_comment_v2_sec.pdf?sfvrsn=0. Accessed 28 Oct. 2019.

  55. United States, Department of Health and Human Services, Centers for Medicare & Medicaid Services. "Kidney Care Choices Model." https://innovation.cms.gov/initiatives/kidney-care-choices-kcc-model/. Accessed 27 Nov. 2019.

  56. Kendall, David and Jacqueline Garry Lampert. "Clearing a Regulatory Path for Value-Based Health Care." Report, Third Way, 23 Mar. 2018, www.thirdway.org/report/clearing-a-regulatory-path-for-value-based-health-care. Accessed 28 Oct. 2019.

  57. Department of Health and Human Services, Centers for Medicare & Medicaid Services. "Medicare Program; Modernizing and Clarifying the Physician Self-Referral Regulations." Proposed Rule, 17 Oct. 2019, www.federalregister.gov/documents/2019/10/17/2019-22028/medicare-program-modernizing-and-clarifying-the-physician-self-referral-regulations. Accessed 10 Nov. 2019. See also Department of Health and Human Services, Office of Inspector General. "Medicare and State Healthcare Programs: Fraud and Abuse; Revisions to Safe Harbors Under the Anti-Kickback Statute, and Civil Monetary Penalty Rules Regarding Beneficiary Inducements." 17 Oct. 2019, www.federalregister.gov/documents/2019/10/17/2019-22027/medicare-and-state-healthcare-programs-fraud-and-abuse-revisions-to-safe-harbors-under-the. Accessed 10 Nov. 2019

  58. United States, Congress, House of Representatives. "H.R.1224—Living Donor Protection Act of 2019." 116th Congress, 1st Session, 15 Feb. 2019, www.congress.gov/bill/116th-congress/house-bill/1224. Accessed 25 Nov. 2019. See also United States, Congress, Senate. "S.511­—Living Donor Protection Act of 2019, 116th Congress, 1st Session, 14 Feb. 2019, www.congress.gov/bill/116th-congress/senate-bill/511. Accessed 25 Nov. 2019.

  59. Testa, Giuliano and Mark Siegler. "Increasing the Supply of Kidneys for Transplantation by Making Living Donors the Preferred Source of Donor Kidneys." Medicine, Dec. 2014, www.ncbi.nlm.nih.gov/pmc/articles/PMC4602590/. Accessed 26 Nov. 2019. See also “US Renal Data System 2018 Annual Data Report: Epidemiology of Kidney Disease in the United States,” United States Renal Data System, 2018, Volume 2, Chapter 6, www.usrds.org/2018/view/v2_06.aspx. Accessed 26 Nov. 2019.

  60. United States, Congress, Senate. Organ Procurement Optimization Act of 2019. Congress.gov, https://www.congress.gov/bill/116th-congress/senate-bill/2063. 116th Congress, 1st Session, S. 2063.

  61. Allecia, JoNel. "A ‘No-Brainer’? Calls Grow For Medicare to Cover Anti-Rejection Drugs After Kidney Transplant." Kaiser Health News, 17 July 17 2019, https://khn.org/news/kidney-transplant-anti-rejection-drugs-medicare-coverage/. Accessed 22 Nov. 2019.

  62. United States, Department of Health and Human Services, Office of the Assistant Secretary for Planning and Evaluation. "Accessing the Costs and Benefits of Extending Coverage of Immunosuppressive Drugs Under Medicare." 10 May 2019, https://aspe.hhs.gov/pdf-report/assessing-costs-and-benefits-extending-coverage-immunosuppressive-drugs-under-medicare. Accessed 28 Oct. 2019.

  63. United States, Congress, House of Representatives. "Letter to Secretary Azar and Administrator Verma on the Proposed ESRD Treatment Choices (ETC) Mandatory Demonstration." 17 Oct. 2019, https://kidneycarepartners.com/wp-content/uploads/2019/10/ETC-Kidney-Model-FINAL-SIGNED.pdf. Accessed 28 Oct. 2019.

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