Approaches to Maximize Safety for Patients with Kidney Diseases after the End of COVID-19 Public Health Emergency

Introduction On January 31, 2020, Secretary of Health and Human Services Alex Azar II declared a public health emergency (PHE) for coronavirus disease 2019 (COVID-19) under Section 319 of the Public Health Service Act. On February 9, 2023, Health and Human Service Secretary Javier Bacerra declared that conditions warranted an end to the PHE on May 9 because rates of infection, hospitalization, and death related to COVID-19 had decreased dramatically. The picture is significantly different for patients living with kidney diseases in whom the effect of COVID-19 has been dramatic. Rates of infection and mortality were far greater than those in the general Medicare population; for the first time in the 50-year history of the Medicare End-Stage Renal Disease (ESRD) program, the population of patients treated by maintenance dialysis decreased in 2020.1 This is most likely a reflection of the disproportionate effect of the pandemic on this vulnerable population. Transplant recipients affected by comorbidities and chronic immunosuppression also demonstrated higher morbidity and mortality than other patients with COVID-19.2 The high risk of COVID-19 for patients with kidney diseases continues despite the end of the PHE and poses unique challenges to this vulnerable population. Table 1 outlines these challenges and possible solutions. Table 1 - Challenges for patients with kidney diseases at the end of the coronavirus disease 2019 public health emergency Challenge Challenges with the End of PHE Proposed Solutions Vaccines • Decreased access• Potential copays• Wastage due to multidose vials • Availability of single-dose vaccine vials• ACIP clarification of designation of patients with CKD, patients with kidney failure, and kidney transplant patients as immunosuppressed for booster doses Testing for infection by SARS-CoV-2 • Decreased availability of home kits• Delays in testing • Continued wide access to home and laboratory testing• No copayments for testing Therapeutics • Delays in access• Out-of-pocket expenses• Need for prior authorization • Prohibiting prior authorization requirements• Prohibiting copayment requirements Loss of insurance coverage • Return to prior standards for governmental insurance programs • Maintaining expanded Medicaid access Expanded telehealth • Decreased access• Lack of broadband coverage in all areas • Legislative action to maintain access beyond 2024 Lack of access to data • Exacerbation of the systematic deficiency to timely and transparent data in real time • Establishing a systematic data repository with clear definitions• Readily queried data system PHE, public health emergency; ACIP, Advisory Council on Immunization Practice; SARS-CoV-2, severe acute respiratory syndrome coronavirus 2. Vaccines The Federal Government made extraordinary efforts to protect Americans from COVID-19. Operation Warp Speed led to the approval and production of antiviral vaccines. The Advisory Council on Immunization Practices led efforts to assure that every American had access to primary vaccines and boosters to provide protective immunity to COVID-19, saving millions of lives. The direct distribution of vaccines to patients in dialysis facilities had a substantial effect on ensuring protection of patients with kidney failure.3 During the PHE, the Federal Government purchased a supply of vaccines for all Americans, eliminating cost as a barrier to immunization. If the end of the PHE signals that patients must pay for all or part of vaccine's cost, patients with kidney diseases and other vulnerable populations will have new barriers to best care. Standard vaccinations, such as influenza, are provided to patients during their routine health care encounters to improve vaccine uptake. Dialysis providers and transplant centers obtain vaccine doses through regular distribution channels but must have single-dose vials available to prevent waste and minimize cost. Testing During the PHE, the Federal Government made laboratory and over-the-counter COVID-19 tests available free of charge. In-center hemodialysis patients must travel to and from dialysis facilities and receive treatment in a congregate setting three times weekly. Patients with CKD and those with kidney transplants require physician evaluations and laboratory studies; most cannot isolate at home. Laboratory testing for COVID-19 identifies infected patients and allows them to be separated from those vulnerable patients who are uninfected. Thus, testing and isolation minimized the spread of COVID-19 in this vulnerable population. If testing is less readily available with the end of the PHE, patients may be exposed and infected where they might have been protected. Because antiviral treatments must be started within a narrow therapeutic window (e.g., within 5–7 days of symptom onset), delayed access to testing may make some ineligible for these effective therapeutics. Therapeutics Antiviral therapies saved millions of lives during the COVID-19 pandemic. The Federal Government provided and paid for these medications to patients with documented severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. If the end of the PHE initiates out-of-pocket expenses and reduces access to treatments depending on an individual's health care coverage,4 fewer patients may receive recommended treatment. Once commercial payers bear part of the expense, they may require preauthorization, documentation of a SARS-CoV-2 infection, and duration of symptoms before treatment. Preauthorization will likely delay access to therapeutic agents for patients at higher risk of poor outcomes. There is no evidence that antiviral agents have been used inappropriately during the PHE. Looking forward, there is no reason to anticipate changes in prescribing patterns, and it would greatly benefit patients if preauthorization was prohibited. Inappropriate use of these therapies may be minimized with a monitoring system to verify stability of prescribing. Insurance Coverage During the PHE, eligibility for Medicaid benefits was expanded. Many patients with kidney disease, especially pediatric patients, gained coverage through the expansion. With the end of the PHE, eligibility will return to the standards that existed before February 2020, placing these patients at risk of loss of coverage and access to care. For those with CKD, less care may increase progression to kidney failure; for those with kidney transplants, less care may increase the risk of allograft failure. Because the cost of preventing these outcomes is substantially less than the cost of dialysis, the United States would benefit greatly from continuing the expanded coverage provided during the PHE. Expanded Telehealth During the PHE, waivers were granted to expand telehealth, including permission for the originating site to be a patient's home and use of unencrypted systems for telehealth visits without risk of penalty under the Health Insurance Portability and Accountability Act. In some areas of the United States, access to telehealth was limited by lack of reliable internet services, particularly in underserved urban and rural areas. Patients with kidney disease were greatly served by increased access to telehealth; not only did it afford them the opportunity to remain in the relative safety of their home but it also facilitated access to care. Secretary Becerra indicated that these waivers will continue until the end of 2024 as reflected in the Consolidated Appropriations Act of 2023. Continuing these waivers beyond 2024 will improve the health of patients with kidney diseases. Access to Data During the PHE, providers were required to report COVID-19–related data to the Centers for Disease Control and Prevention, including positive tests for SARS-CoV-2 and antiviral vaccinations. Such data can be used to determine transmission patterns and define pandemic-related morbidity and mortality. Imprecise definitions of severe COVID-19 and of mortality due to COVID-19 made it difficult to interpret these data. While the United States Renal Data System provides a wealth of data about kidney diseases in the United States and how patients with kidney diseases are affected by diseases like COVID-19, publication 2 years after data are collected limits its utility. Furthermore, this systemic deficiency will be exacerbated after the end of the PHE when mandatory data reporting ends. A lesson learned from the pandemic: We need a data repository with clear reporting standards and tools for appropriate users to use these data for timely analysis of the effect of a next pandemic or other health emergency in this vulnerable population.5 Improvements in the burden of COVID-19 portend the end of the PHE, but the risks of infection, severe morbidity, and mortality continue for patients with kidney disease. Modest but important steps to mitigate this risk include clarification of Advisory Council on Immunization Practice vaccine recommendations, single-dose vaccine vials, ready access to testing for SARS-CoV-2 and antiviral therapeutics, expansion of Medicaid, action to improve access to telehealth, and a readily available easily accessible data repository.