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The COVID-19 Pandemic Converges With Kidney Policy Transformation: Implications for CKD Population Health

2020; Elsevier BV; Volume: 77; Issue: 2 Linguagem: Inglês

10.1053/j.ajkd.2020.10.004

1523-6838

Sri Lekha Tummalapalli, Neil D. Warnock, Mallika L. Mendu,

Healthcare Policy and Management

Policy Forum:FEATURE EDITOR:Daniel E. WeinerADVISORY BOARD:L. Ebony BoulwareKevin EricksonEduardo Lacson JrBruce M. RobinsonWolfgang WinkelmayerPolicy Forum highlights aspects of nephrology relating to payment and social policy, legislation, regulation, demographics, politics, and ethics, contextualizing these issues as they relate to the lives and practices of members of the kidney community, including providers, payers, and patients. Policy Forum: FEATURE EDITOR: Daniel E. Weiner ADVISORY BOARD: L. Ebony Boulware Kevin Erickson Eduardo Lacson Jr Bruce M. Robinson Wolfgang Winkelmayer Policy Forum highlights aspects of nephrology relating to payment and social policy, legislation, regulation, demographics, politics, and ethics, contextualizing these issues as they relate to the lives and practices of members of the kidney community, including providers, payers, and patients. The coronavirus disease 2019 (COVID-19) pandemic has illustrated the vulnerability of patients with chronic kidney disease (CKD) to poor and inequitable clinical outcomes during health care crises.1Novick T.K. Rizzolo K. Cervantes L. COVID-19 and kidney disease disparities in the United States.Adv Chronic Kidney Dis. 2020; 27: 427-433Abstract Full Text Full Text PDF Scopus (23) Google Scholar Persons with CKD are at increased risk for hospital admissions and critical illness due to COVID-19.2Petrilli C.M. Jones S.A. Yang J. et al.Factors associated with hospital admission and critical illness among 5279 people with coronavirus disease 2019 in New York City: prospective cohort study.BMJ. 2020; 369: m1966Crossref PubMed Scopus (1806) Google Scholar Disadvantaged populations, including Black and Hispanic individuals and those with low socioeconomic status, are at disproportionate risk for both kidney disease3Centers for Disease Control and PreventionChronic Kidney Disease Surveillance System—United States.http://www.cdc.gov/ckdDate accessed: June 1, 2020Google Scholar and acquiring COVID-19. For example, in a cohort of patients in Louisiana, Black patients were more likely to have CKD and be hospitalized and die from COVID-19.4Price-Haywood E.G. Burton J. Fort D. Seoane L. Hospitalization and mortality among black patients and white patients with Covid-19.N Engl J Med. 2020; 382: 2534-2543Crossref PubMed Scopus (1209) Google Scholar These disparities stem from social determinants of health, including community context and access to a healthy lifestyle (contributing to CKD), household crowding and inability to work from home (precipitating COVID-19), and structural racism in access to economic opportunity. Furthermore, individuals hospitalized with COVID-19 experience high rates of acute kidney injury requiring dialysis, which may result in eventual residual CKD, potentially exacerbating existing disparities. COVID-19 has necessitated dramatic care delivery and health care policy changes at a national and global level. Concurrently, we are witnessing the Advancing American Kidney Health (AAKH) Initiative unfold, the most pivotal kidney health policy since the Medicare End-Stage Renal Disease entitlement of 1972.5Office of the The Assistant Secretary for Planning and Evaluation. Advancing American Kidney Health.https://aspe.hhs.gov/system/files/pdf/262046/AdvancingAmericanKidneyHealth.pdfDate accessed: June 1, 2020Google Scholar The AAKH Executive Order, signed in July 2019, announced a sweeping array of nephrology initiatives, including new payment models, investments in technology and innovation, and a focus on delaying CKD progression and increasing the use of home dialysis to support improved quality of life. In this editorial, we outline COVID-19–related payment and regulatory changes and their implications for CKD care delivery and the AAKH Initiative. We then recommend actions for health systems and national professional organizations to achieve optimal equitable CKD population health in the context of COVID-19 and kidney policy transformation (Table 1).Table 1CKD Population Health in the COVID-19 EraAimEntityRecommendationRefine quality measurement in CKDNational nephrology organizations, quality metric organizations, and patient advocacy groupsaIncluding the American Society of Nephrology, National Kidney Foundation, Renal Physicians Association, National Quality Forum, National Committee for Quality Assurance, and the Agency for Healthcare Research and Quality.•Continue to develop CKD-specific patient-centered measures that expand beyond dialysis-focused measuresState and federal government and payors•Create a Nephrology MIPS Value Pathway•Use randomization or staggered implementation for evidence-based policy generationCreate a national CKD quality collaborativeNational professional organizations and funding agencies•Develop content and materials for best practice dissemination•Invest in programmatic support for nephrology practices and health systems to engage in quality improvementInvest in data management for CKDNephrology practices•Proactively engage in panel managementNephrology practices, health systems, and payors•Engage with health systems leadership to develop CKD registriesExpand telehealth and address the digital divideNephrology practices and health systems•Engage in telephone-based strategies (not dependent on broadband access), including telephone calls, mobile applications, and text messagingLocal, state, and federal governments•Invest in infrastructure that expands broadband internet accessAbbreviations: CKD, chronic kidney disease; COVID-19, coronavirus disease 2019; MIPS, Merit-Based Incentive Payment System.a Including the American Society of Nephrology, National Kidney Foundation, Renal Physicians Association, National Quality Forum, National Committee for Quality Assurance, and the Agency for Healthcare Research and Quality. Open table in a new tab Abbreviations: CKD, chronic kidney disease; COVID-19, coronavirus disease 2019; MIPS, Merit-Based Incentive Payment System. Early in the COVID-19 crisis, the Centers for Medicare & Medicaid Services (CMS) announced a broad set of flexibilities and waivers of quality reporting requirements.6Centers for Medicare & Medicaid ServicesMedicare and Medicaid programs; policy and regulatory revisions in response to the COVID-19 public health emergency.http://federalregister.gov/d/2020-06990Date accessed: June 1, 2020Google Scholar Financial penalties were waived for physician practices not submitting Merit-Based Incentive Payment System (MIPS) data and for many other CMS quality programs. This "regulatory relief" has had a positive reception given costs associated with quality reporting,7Casalino L.P. Gans D. Weber R. et al.US physician practices spend more than $15.4 billion annually to report quality measures.Health Aff (Millwood). 2016; 35: 401-406Crossref PubMed Scopus (199) Google Scholar administrative burden, and uncertainty regarding whether some quality measures meaningfully improve care. Others have argued that given substantial quality-of-care gaps in CKD awareness, goal-directed medical therapy, and transition to kidney replacement therapy (KRT), well-designed quality, value, and population health programs are needed to make dramatic necessary improvements in kidney care delivery.8Mendu M.L. Tummalapalli S.L. Lentine K.L. et al.Measuring quality in kidney care: an evaluation of existing quality metrics and approach to facilitating improvements in care delivery.J Am Soc Nephrol. 2020; 31: 602-614Crossref PubMed Scopus (28) Google Scholar The question remains: how should quality programs for kidney care be reimagined amid the COVID-19 crisis? Several guiding principles can advance quality programs in nephrology. First, implementing more CKD-specific, nephrology-oriented, and patient-centered measures can shift quality efforts away from solely dialysis-focused measures and enable quality measurement to drive improvements in kidney care.8Mendu M.L. Tummalapalli S.L. Lentine K.L. et al.Measuring quality in kidney care: an evaluation of existing quality metrics and approach to facilitating improvements in care delivery.J Am Soc Nephrol. 2020; 31: 602-614Crossref PubMed Scopus (28) Google Scholar The new Kidney Health Evaluation Measure is being incorporated into the Healthcare Effectiveness Data and Information Set for CKD detection in patients with diabetes.9National Kidney FoundationEvaluation of Kidney Health Clinical Quality Measure. Developed by the NKF Quality Measures Technical Expert Panel.https://www.kidney.org/sites/default/files/nkf-kidney-health-evaluation-measure-worksheet.pdfDate accessed: June 1, 2020Google Scholar Other quality measures, including a standardized mortality ratio, evidence of delayed progression to KRT need, and home dialysis and transplantation rates, are currently under development.10Centers for Medicare & Medicaid Services (CMS)Center for Medicare and Medicaid Innovation (CMMI) Kidney Care Choices (KCC) Model. Request for applications.https://innovation.cms.gov/files/x/kcc-rfa.pdfDate accessed: June 1, 2020Google Scholar In light of the economic impact of COVID-19 on physician practices and hospitals reliant on fee-for-service payments, there will likely be a shift toward more value-based care in the coming decade, and these new CKD quality measures will be needed to monitor the effectiveness of care being delivered. Second, creating a Nephrology MIPS Value Pathway, a more streamlined iteration of the MIPS program, would standardize a set of quality measures that nephrology practices report, allowing for cross-regional comparisons. As a final consideration, it is often challenging to evaluate the effectiveness of quality programs because they are often implemented uniformly across the nation, amid other concurrently changing policies. Advocating for CMS to re-introduce quality programs differentially across the country, using randomization or staggered implementation, would allow researchers to better evaluate the impact of programs on the quality, utilization, and equity in care delivery and lead to evidence-based policy generation. Before the pandemic, the US health care system lacked the infrastructure and incentives to ensure effective, coordinated, patient-centered care for CKD. Evidence-based population health tools, including CKD registries,11Mendu M.L. Ahmed S. Maron J.K. et al.Development of an electronic health record-based chronic kidney disease registry to promote population health management.BMC Nephrol. 2019; 20: 72Crossref PubMed Scopus (26) Google Scholar e-consultation, and panel management,12Choi M. Montgomery E. Saffer T. Vassalotti J. National Kidney Foundation (NKF) chronic kidney disease change package.https://www.kidney.org/sites/default/files/02-11-8036_JBI_CKD_ChangePackV17.pdfDate accessed: May 31, 2020Google Scholar can facilitate a proactive approach to CKD care and risk stratification, particularly in the context of COVID-19. However, population health strategies for CKD are incompletely implemented due to limited time, resources, and/or local expertise, as well as financial disincentives for CKD care compared with KRT care.13Berns J.S. Saffer T.L. Lin E. Addressing financial disincentives to improve CKD care.J Am Soc Nephrol. 2018; 29: 2610-2612Crossref PubMed Scopus (8) Google Scholar Capitated payments for CKD care in the upcoming Kidney Care Choices model provide built-in reimbursement for CKD population health strategies, but these payment changes are limited to participants in that model.14CMS Innovation Center models COVID-19 related adjustments.https://www.cms.gov/files/document/covid-innovation-model-flexibilities.pdfDate accessed: June 3, 2020Google Scholar Accordingly, we call for the establishment of a national CKD Quality Collaborative to provide content and programmatic support for nephrology practices and health systems engaging in CKD quality efforts. For example, the American Heart Association's "Get with the Guidelines" program partners with hospitals to implement guidelines through consultation, webinars, and workshops and has demonstrated substantial improvements in process measures of care and reductions in length of stay and readmissions.15Ellrodt A.G. Fonarow G.C. Schwamm L.H. et al.Synthesizing lessons learned from Get With the Guidelines: the value of disease-based registries in improving quality and outcomes.Circulation. 2013; 128: 2447-2460Crossref PubMed Scopus (98) Google Scholar A national CKD Quality Collaborative would cultivate clinical champions, support improvement, and provide best practices for rapid-cycle implementation and evaluation through pragmatic trials. Funding for such a program is a key constraint and would require investments from national professional societies and/or funding agencies. Establishing a national CKD Quality Collaborative aligns with the first goal of the AAKH Initiative to decrease the incidence of kidney failure. During the COVID-19 pandemic, there has been limited national surveillance of CKD care parameters due to fragmented data sources and barriers to obtaining real-time data. Concurrently, outpatient visit volumes dramatically decreased, with a nearly 40% cumulative visit deficit between March and June 2020.16Mehrotra A, Chernew M, Linetsky D, Hatch H, Cutler D. The impact of the COVID-19 pandemic on outpatient visits: practices are adapting to the new normal (Commonwealth Fund, June 2020). https://doi.org/10.26099/2v5t-9y63. Accessed June 1, 2020.Google Scholar For patients with late-stage CKD whose transplant evaluations, modality education, and access placements have been delayed due to COVID-19, there is an immediate need to identify and address gaps in care to avoid long-term consequences. It is unknown whether delays in care during this period led to an increase in "crash-start" or unplanned dialysis initiations, which are associated with higher mortality. Furthermore, close monitoring of late-stage CKD is crucial to facilitate transitions to home dialysis, in line with AAKH Initiative goals, because evidence indicates that if hemodialysis is the initial modality, rates of switching to peritoneal dialysis are exceedingly low after 1 month.17Lin E. Chertow G.M. Bhattacharya J. Lakdawalla D. Early delays in insurance coverage and long-term use of home-based peritoneal dialysis.Med Care. 2020; 58: 632-642Crossref PubMed Scopus (8) Google Scholar In sum, continued comprehensive late-stage CKD care during COVID-19, amid an increased use of telehealth, is central to the second AAKH Initiative goal of increasing home dialysis initiation.5Office of the The Assistant Secretary for Planning and Evaluation. Advancing American Kidney Health.https://aspe.hhs.gov/system/files/pdf/262046/AdvancingAmericanKidneyHealth.pdfDate accessed: June 1, 2020Google Scholar CKD care delivery dramatically changed during the pandemic, with >50% of ambulatory visits initially shifting to telehealth in many health systems and nephrology practices.18Renal Physicians AssociationTelehealth survey results.https://cdn.ymaws.com/www.renalmd.org/resource/resmgr/legregscomp/public_policy/telehealth_survey_detailed_r.pdfGoogle Scholar In March 2020, CMS expanded access to telehealth by lifting originating site restrictions, broadening eligible providers, and waiving several other requirements,19Centers for Medicare & Medicaid ServicesESRD Provider Telehealth and Telemedicine Tool Kit.https://www.cms.gov/files/document/esrd-provider-telehealth-telemedicine-toolkit.pdfGoogle Scholar which has had several implications for nephrology care delivery, as previously described.20Jain G. Ahmad M. Wallace E.L. Technology, telehealth and nephrology: the time is now.Kidney360. 2020; (Accessed June 1, 2020)https://doi.org/10.34067/KID.0002382020Crossref Scopus (12) Google Scholar,21Lew S.Q. Wallace E.L. Srivatana V. et al.Telehealth for home dialysis in COVID-19 and beyond: a perspective from the American Society of Nephrology COVID-19 Home Dialysis Subcommittee [published online ahead of print September 28, 2020]. Am J Kidney Dis.https://doi.org/10.1053/j.ajkd.2020.09.005Google Scholar As a result, the "digital divide" of lower access to internet-based technology among rural, elderly, Black and/or Hispanic, and low socioeconomic status individuals has been accentuated during the pandemic.22Turner S.D. Digital denied: the impact of systemic racial discrimination on home-internet adoption. December, 2016.https://www.freepress.net/sites/default/files/legacy-policy/digital_denied_free_press_report_december_2016.pdfDate accessed: June 1, 2020Google Scholar Older and disadvantaged populations are less likely to have computer or broadband internet access and also more likely to have CKD, creating challenges for nephrologists and health systems to deliver high-quality care in the context of COVID-19. The internet has been foundational to receiving COVID-19–related information and accessing health care. As a result, it is necessary to consider creative solutions to ameliorate the effects of the digital divide on existing chronic disease inequities. As a temporary solution, CMS instituted that reimbursement for telephone-only visits would have parity with video/audio visits retroactive to March 1, 2020,23Centers for Medicare & Medicaid ServicesCOVID-19 emergency declaration blanket waivers for health care providers.https://www.cms.gov/files/document/summary-covid-19-emergency-declaration-waivers.pdfDate accessed: June 1, 2020Google Scholar and professional organizations are advocating for these changes to become permanent.24Medical Professional Societies Audio-only encounters as a vital source of health care services during COVID-19.https://cms.amga.org/AMGA/media/PDFs/Advocacy/Correspondence/HHS%20Correspondence/audio-only-telehealth-ltr.pdfDate accessed: June 1, 2020Google Scholar Longer-term national, regional, and state solutions are also needed to address the digital divide. On August 3, 2020, an Executive Order on Improving Rural Health and Telehealth Access was signed, which specified infrastructure and technology improvements, funding for preventive care, and increased rural access to health care.25The White HouseExecutive Order on Improving Rural Health and Telehealth Access.https://www.whitehouse.gov/presidential-actions/executive-order-improving-rural-health-telehealth-access/Date accessed: June 1, 2020Google Scholar Health systems caring for CKD populations also have a role. Smartphone technology may bridge digital gaps because smartphone ownership is high even in individuals without computer or broadband internet access.26Perrin A. Smartphones Help Blacks, Hispanics Bridge Some–But Not All–Digital Gaps With Whites. Pew Research Center, 2017Google Scholar Text messaging may be a promising tool and needs further study in persons with CKD.27Diamantidis C.J. Becker S. Health information technology (IT) to improve the care of patients with chronic kidney disease (CKD).BMC Nephrol. 2014; 15: 1-6Crossref PubMed Scopus (82) Google Scholar An ongoing randomized clinical trial of patients with CKD is examining the effectiveness of telephone-based self-management, including low-literacy educational materials and telephone health coaching.28Tuot D.S. Velasquez A. McCulloch C.E. et al.The Kidney Awareness Registry and Education (KARE) study: protocol of a randomized controlled trial to enhance provider and patient engagement with chronic kidney disease..BMC Nephrol. 2015; 16: 166Crossref PubMed Scopus (32) Google Scholar Particularly in the context of COVID-19, digital solutions for patient engagement are essential elements in a comprehensive CKD population health strategy. In summary, COVID-19 has highlighted the vulnerability of patients with CKD to worse inequitable clinical outcomes and necessitated fundamental changes to our health systems at a historic juncture in kidney health policy. The COVID-19 pandemic has shown us how rapidly health systems can mobilize toward a singular mission. The AAKH Initiative aims to achieve laudable goals of reducing the incidence of kidney failure, increasing rates of home dialysis use and kidney transplantation, and fundamentally transforming how kidney care is delivered. The convergence of these events has profound implications for patients with kidney disease, and this is the time for bold kidney care innovation at a population level. There is great urgency to implement and evaluate population health approaches to reconceptualize CKD care and fulfill the goals of the AAKH Initiative in the setting of the COVID-19 pandemic. Sri Lekha Tummalapalli, MD, MBA, MAS, Neil Warnock, MD, MS, and Mallika L. Mendu, MD, MBA. Dr Tummalapalli is supported by funding from the National Institute of Diabetes and Digestive and Kidney Diseases F32DK122627. The funders had no role in defining the content of the manuscript. Drs Tummalapalli and Mendu receive consulting fees from Bayer AG unrelated to the submitted work. Dr Warnock is employed by Bayer AG. The authors thank David White, ASN Regulatory and Quality Officer, for his extraordinary policy expertise and leadership. Received September 7, 2020. Evaluated by 2 external peer reviewers, with direct editorial input from the Feature Editor and a Deputy Editor. Accepted in revised form October 28, 2020.