The flurry of kidney-related policies continues unabated, and 2022 brings to the fore another set of policy challenges and opportunities (Figure 1).
Policies to Watch in 2022
Citation: Kidney News 14, 1
A new eGFR equation
In 2020, the National Kidney Foundation (NKF) and the American Society of Nephrology (ASN) established a joint task force aimed at addressing the use of race in the estimated glomerular filtration rate (eGFR). In a highly anticipated recommendation, the task force published alternatives to using race, a social construct, in eGFR. The task force also tackled challenges for the nephrology community moving forward (1). Two key recommendations have emerged. First, the task force recommends that all laboratories immediately implement a new Chronic Kidney Disease-Epidemiology Collaboration (CKD-EPI) equation refit without the race variable (2). Second, because cystatin C-based equations are less biased, national efforts should be made to facilitate increased availability and access to cystatin C. Notwithstanding uniform agreement that cystatin C is more accurate, cystatin C still requires laboratory standardization, a faster turnaround time, and a lower price tag. Now that consensus opinion has been achieved, the nephrology community and policymakers must address the challenge of implementing these recommendations.
COVID-19 vaccinations and new therapeutics
Vaccinations for the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) were a welcome addition to combating the global pandemic. However, the standard two-dose regimens do not appear sufficient to prevent infection, especially in immunocompromised transplant recipients where even four doses may not convey a humoral response (3–5). At the end of 2021, the US Food and Drug Administration (FDA) authorized the use of a single booster shot from either Moderna or Pfizer-BioNTech for all adults 18 and older, especially those who are immunocompromised, including those who received kidney transplant. In 2022, we anticipate further studies on whether additional booster doses will be warranted. Additionally, new therapeutics are now on the horizon (6, 7) and may signal the start of overcoming the pandemic in 2022.
The ESRD Treatment Choices and Kidney Care Choices models
Medicare's End-Stage Renal Disease (ESRD) Treatment Choices (ETC) model formally started in January 2021, whereas the Kidney Care Choices (KCC) model was delayed until January 2022 due to the coronavirus pandemic. Thus far, anecdotal feedback from the ETC is limited. This year, Medicare has proposed new equity adjustments to help address difficulties that safety-net providers might have in meeting benchmarks (8). Once both models have been fully implemented, we anticipate feedback from participants in the kidney community.
The Improving Access to Home Dialysis Act of 2021
With tailwinds from the ETC and KCC, home dialysis advocacy remains strong. On September 29, 2021, the Improving Access to Home Dialysis Act of 2021 (H.R.5426) was introduced to the House of Representatives as bipartisan legislation to help improve access and education for home dialysis modalities. The proposed bill would provide coverage for staff-assisted home dialysis and ensure comprehensive patient education on all dialysis modality options (9). Undoubtedly, this bill would have large implications on the ESRD Prospective Payment System (PPS) by expanding home dialysis to patients who otherwise could not perform home dialysis on their own.
We are optimistic that these policies will help improve kidney health and shape the future of nephrology.
References
- 1.↑
Delgado C, et al. A unifying approach for GFR estimation: Recommendations of the NKF-ASN Task Force on Reassessing the Inclusion of Race in Diagnosing Kidney Disease. JASN [published online September 22, 2021]. doi: 10.1053/j.ajkd.2021.08.003
- 2.↑
Inker LA, et al. New creatinine- and cystatin C-based equations to estimate GFR without race. N Engl J Med 2021; 385:1737–1749. doi: 10.1056/NEJMoa2102953
- 3.↑
Hall VG, et al. Randomized trial of a third dose of mRNA-1273 vaccine in transplant recipients. N Engl J Med 2021; 385:1244–1246. doi: 10.1056/NEJMc2111462
- 4.
Boyarsky BJ, et al. Antibody response to 2-dose SARS-CoV-2 mRNA vaccine series in solid organ transplant recipients. JAMA 2021; 325:2204. doi: 10.1001/jama.2021.7489
- 5.↑
Kamar N, et al. Assessment of 4 doses of SARS-CoV-2 messenger RNA-based vaccine in recipients of a solid organ transplant. JAMA Netw Open 2021; 4:e2136030. doi: 10.1001/jamanetworkopen.2021.36030
- 6.↑
Pfizer's novel COVID-19 oral antiviral treatment candidate reduced risk of hospitalization or death by 89% in interim analysis of phase 2/3 EPIC-HR study. Pfizer, November 5, 2021. Accessed November 16, 2021. https://www.pfizer.com/news/press-release/press-release-detail/pfizers-novel-covid-19-oral-antiviral-treatment-candidate
- 7.↑
Merck and Ridgeback's molnupiravir, an oral COVID-19 antiviral medicine, receives first authorization in the world. Business Wire November 4, 2021. Accessed November 19, 2021. https://www.businesswire.com/news/home/20211104005560/en/Merck-and-Ridgeback%E2%80%99s-Molnupiravir-an-Oral-COVID-19-Antiviral-Medicine-Receives-First-Authorization-in-the-World
- 8.↑
Centers for Medicare & Medicaid Services, Department of Health and Human Services. Medicare Program; End-Stage Renal Disease Prospective Payment System, Payment for Renal Dialysis Services Furnished to Individuals With Acute Kidney Injury, End-Stage Renal Disease Quality Incentive Program, and End-Stage Renal Disease Treatment Choices Model. Federal Register November 8, 2021; 86:61874. https://www.aapc.com/codes/webroot/upload/general_pages_docs/document/2021-23907.pdf
- 9.↑
117th Congress (2021–2022). H.R.5426 - Improving Access to Home Dialysis Act of 2021. Congress.gov, September 29, 2021. https://www.congress.gov/bill/117th-congress/house-bill/5426/text
