The authority of courage and compassion: Healthcare policy leadership in addressing the kidney disease public health epidemic

Abstract Recent developments in US kidney‐related healthcare policy have made chronic kidney disease (CKD) a societal focus in the United States. In the biggest policy change since the 1972 Social Security Amendments that extended Medicare coverage to patients with kidney failure regardless of age, a 2019 presidential executive order pledged to reduce end‐stage kidney disease, slow CKD progression, increase kidney transplants, and focus on home dialysis care. This manuscript seeks to outline key factors that can enable this milestone moment to evolve a policy framework that improves the health of society while being economically sustainable. Understanding the sociohistorical context of healthcare policy and the related lessons learned demonstrates that policy must take a broader view of the societal and system wide factors that affect chronic illness. Addressing the full breadth of the CKD epidemic requires looking at factors from both inside and outside traditional medical‐pathophysiological environments, including social determinants of health. This more fulsome insight will enable policy to better align the broad range of people and organizations who are working to combat the disease. By creating patient‐centered policy that both evolves with the speed of innovation and addresses root causes of CKD instead of narrowly focusing on symptoms or comorbidities alone, leaders in the public square have an historic opportunity to thoughtfully create the common ground of a lasting policy legacy that improves society's health today and for generations to come.

including doubling the number of kidney transplants in the United States. The administration also committed to move dialysis patients away from commercial centers to anticipated less expensive, more convenient in-home care, with a goal of 80% of patients with incident ESKD to receive a kidney transplant or to obtain their renal replacement therapy at home.
In a press briefing, Joe Grogan, head of the White House Domestic Policy Council, described the set of initiatives as the singular biggest change in kidney care since the passage of the 1972 Social Security Amendments, which created the Medicare ESKD benefit, extending Medicare coverage to kidney failure patients, regardless of age. In light of this historic event, the most striking observation is the 47-year time gap between these two seminal pieces of healthcare policy and the scientific and market innovations that meanwhile happened in between.
This perspectives manuscript is an attempt to address the question surrounding kidney care-related healthcare policy in the United States, first looking at the evolution of our health system generally, and then specifically at how a focused approach can enable a path forward to lasting, effective policy.

| HE ALTH C ARE P OLI C Y IN HIS TORIC CONTE X T: ENAB LING ACCE SS TO INNOVATION
Lags in time between the point a new, socially valuable therapy is available to the time policy can make it widely accepted and utilized by all in need must be thought of as an opportunity cost: the longer it takes for policy changes to bring innovations that address societal health needs to market, the greater the health burden to society, and the greater the economic burden to the system. Because healthcare innovation is an expensive investment in the future good for society, advancements such as scientific breakthroughs, new therapies and health products most often come from the private sector first, requiring policy to evolve-and in many cases catch up-in order to make such innovations available at scale. illness. This is also an example of medical technology challenging our social mores, the societal norms of morality that often underpin legal and regulatory changes impacting healthcare. In the US people with kidney failure are uniquely positioned compared to people with other expensive, chronic conditions in that they are eligible for Medicare coverage regardless of age. This anomaly in our Medicare coverage rules is the result of a courageous few on the front lines of kidney care to effectively position the issue with policy makers.
A US healthcare policy and societal journey timeline shows the relationships of policy to society's evolving needs. Health policy from the 1930s through the 1990s focused generally on a piecemeal approach to expanding access to healthcare. The impetus for expanding access was driven in part by the pace of technological advancement in this period, which created a societal need for access to new treatments ( Figure 1).
Much of the expansion policy through the late 60s and early 70s was driven by the GI Generation who were at the peak of their policy-making power. Having lived through the great depression and World War II, the GI Generation was characterized by a sense of community; they supported the New Deal and joined labor unions, and in their later years formed the American Association of Retired F I G U R E 1 Timeline of US healthcare system policy milestones; kidney care milestones; key societal events; and related generations. (See Supplemental Information of Policy Milestones) Persons, the advocacy organization otherwise known as AARP. 1 Early policy focused heavily on preparedness and ensuring a healthy workforce. Later, as the GI Generation faced the age of retirement, they were largely responsible for the passage of Medicare.
The experiences in World War II gave rise to new legislative efforts to expand access to healthcare by more specifically addressing the costs of care, which, for the first time, began to act as a barrier. Many policy makers at this time lived through or fought in World War I and II, and it is no surprise that legislation passed in this period focused on ensuring citizens were healthy enough to serve, should the need arise. While this legislation created a pathway for drug classes to find their way into the ESKD bundled payment model, the policy came with distinct operational issues from the start: 1. Transitional Drug Add-On Payment Adjustment did not account for many logistical requirements needed for providers to operationalize the policy in the field 2. The policy did not address system wide structural issues, such as the dramatic difference in pharmacy dispensing authority between a retail or mail order pharmacy dispensing laws vs those dispensing needs under TDAPA of a dialysis clinic.
3. The policy did not take into account the various logistical pathways patients get medications across the board such as Medicare vs Medicaid vs private insurance.

| CRE ATING ECONOMIC ALLY SUS TAINAB LE HE ALTH C ARE P OLIC Y
To be lasting and effective, healthcare policy must broaden its general view of a disease state to include societal and system wide factors that affect the disease. This includes deficiencies in the health system, high rates of unhealthy behaviors and adverse social and environmental conditions (also known as social determinants of health- Stephenson, a 22-year-old woman, of sickle cell disease, one of the more common genetic disorders. As new therapies become available to treat or cure previously debilitating conditions, policy makers will continue to struggle with the very question legislators faced in 1972.
What is the role of the government in ensuring access to these technologies, and at what cost?
The urgency and intensity of the question has escalated in recent years as healthcare costs continue to increase exponentially and more Americans feel the strain of healthcare consuming nearly 18% of the country's gross domestic product. 3  This societal choice was driven in part by the development of kidney care device and medical therapeutic innovations that shaped societal mores toward the government's responsibility to make a particular therapy available to those who could benefit but could not otherwise afford it. While there has been much debate and some consternation over the evolution of this therapy since 1972, we must not forget that the alternative for patients was assured death. On the passage of the ESKD benefit, Senator Russell What policy makers in 1972 perhaps could not fully understand was that the dialysis machine was just the tip of the iceberg, and they could not anticipate the breakneck pace of technological innovation in healthcare in the coming decades. 8  The true environment today is that structural issues in the current policy framework require that organizations use cross-payer or subsidies to maintain sustainability of the dialysis therapy systems much as acute care hospitals use service line subsidies to support unsustainable therapies they must provide to the communities they serve. This reality is due to policy framework forecasting that underestimated, many years ago, the scope and breadth of the number of people and conditions that need treatment when trying to manage a complex ESKD population.
The reality is that commercial patients subsidize patients covered by Medicare and Medicaid in many cases and these structural issues lead to discord for many stakeholders in the system about how to best care for the whole population of people with ESKD equitably. It is the patients' desire (along with their nephrologists and other caregivers) to survive and function at the highest level possible in their communities that will pressure policy makers to resolve these structural problems and create a resilient, reliable healthcare system with enough efficiency to sustain the broad | 39 MADDUX access to high quality care required to help people with kidney disease lead productive lives.
Distinct structural solutions will be further required to avoid unintended consequences (as seen in the TDAPA extension), which will further confuse the generation of an accurate cost baseline when time comes to rebase the prospective payment system for ESKD care in the United States. As policy makers continue to seek the right balance of access and cost, perhaps the structure and funding of the Medicare ESKD benefit can serve as a lesson: policy solutions should seek to avoid the slowing of future investment. TDAPA is ongoing today and there is the potential for serial transitions from one drug to another within a class as they enter the market. CMS has not clarified its intent and is still unclear whether the first drug that enters the market, or each new drug that enters the market in a new functional category, will get the 2 years add-on payment. The Hypoxia Inducible Factor prolyl hydroxylase inhibitors (HIF-PHIs, also known as HIF stabilizers) will potentially set a precedent for this particular issue if they are deemed part of the future bundle and placed into the TDAPA portfolio.

| PATIENT-CENTERED P OLI C Y: DRIVER OF EFFI CIEN C Y, B E T TER OUTCOME S , AND SYS TEM WIDE ALI G NMENT
The evolution toward patient-centered health policy provides the basis for how the policy maker must respond.
Three hypothetical patient profiles demonstrate the need for policy that is relevant to the needs of individual patients and their unique circumstances, underscoring the critical importance for policy to enhance power and choice for patients: • The low income, elderly ESKD patient with multiple comorbidities may live in a "food desert" and not have adequate access to food that is critical for her nutritional competence.
• The patient who has an acute illness leading to acute kidney injury has a substantial chance to recover kidney function but will also require care coordination during recovery while completing the therapeutic course required for resolution of the acute illness. This requires flexibility in the system to keep the patient in the correct site of care that avoids attenuation of recovery while maintaining every chance for the patient to ultimately return to a normal life without severe chronic kidney impairment.
• Thirdly, the 40-year-old patient who is destined to have a kidney disorder because of known genetic risks wants to find the right medical team to help him navigate the complex decisions around modality and timing of various kidney replacement therapies while staying independent enough to work and manage a family.
These examples represent both a patient's universal will to survive and the complexity in which the policy framework must accommodate many different individual life scenarios. Policy will fall short without addressing the issues associated with avoidable health crises in kidney failure patients and the need for insights and actions that help these individuals remain productive. Creating a patient-centered policy process requires an environment focused on delivering precise, personalized care. Individual patients should get the right therapy at the right time for their individual circumstance of kidney failure, but within a structured framework of options. This requires policy to adapt to our evolving understanding of the disease state, and to align policy with breaking market innovations that have promise to make therapies more precise.
For example, forward-thinking policy that considers the molecular and genetic levels of a disease will offer greater opportunity to create a case for more precise therapies. This may involve shifting our fundamental approach to how we approach kidney diseases: If we can imagine a time when kidney diseases have their pathologic classification enhanced by molecular markers and genetic variations, we can also imagine new opportunities to improve outcomes and lower costs by delivering targeted therapies to which a specific, individual patient is more likely to respond.
Policy that enables more precise personalized kidney care must also have a full view of both the patients' lifetime care journey and the role of patient power and choice in their care (Figure 4).

| P OLIC Y A S L A S TING LEG AC Y: FIND ING A COMMON G ROUND
The phrase "I care about people" is the sentiment at the heart of healthcare policy that is truly focused on a societal need. In fact, The analysis indicated how differences in the clarity of stated policy objectives, the quality of data collected at the time of policy enactment, and prior evidence supporting policy objectives can influence a policy's success as well as efforts to evaluate its success. Furthermore, it showed how clarity of purpose and intent can help avoid unintended consequences such as the misalignment of the very people and organizations responsible for enacting policy through incentives not clearly defined. 12 In short, policy without the mutual understanding created by a foundational common ground may be policy doomed to fail.
To summarize what history has taught, future policy should consider distinct imperatives in order to be socially and economically viable ( Figure 5). With the magnitude of the economic, societal, medical, and logistical understandings required for truly effective policy, it is perhaps the compassionate policy maker who is best equipped to create lasting legislation.