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Federal Register / Vol. 86, No. 187 / Thursday, September 30, 2021 / Rules and Regulations
I. Comments of General Support One commenter welcomed the proposed changes to 38 CFR 4.115a, including the replacement of a vague term intermittent intensive management with a more specific reference suppressive drug therapy in the urinary tract infection UTI
criteria. The commenter supported VAs proposal to eliminate subjective terms such as markedly, some, and slight in the renal dysfunction criteria and to replace them with specific, objective laboratory findings, such as the glomerular filtration rate GFR and albumin/creatinine ratio ACR. The commenter noted that these revisions will likely result in a more efficient application of the rating schedule of disabilities and will benefit many veterans with kidney diseases. VA
appreciates the commenters support and makes no changes based on this comment.
Another commenter supported VAs proposal to update medical terminology and 38 CFR 4.115a. The commenter noted that the proposed changes include more specific, objective laboratory findings such as GFR. The commenter also noted that the National Kidney Foundation indicated that an estimated glomerular filtration eGFR is the best test to measure the level of kidney function and to determine the stage of the kidney disease. VA appreciates the commenters support and makes no changes based on this comment.

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II. Comments Regarding 38 CFR 4.115a One commenter expressed an opinion that the GFR values in a previously proposed rule, which was published on July 28, 2017, are more in line with National Kidney Foundation standards.
See 82 FR 35140. However, that July 2017 proposal was formally withdrawn through notice published in the Federal Register on March 5, 2019. See 84 FR
7844. Although the commenter asserted that the July 2017 proposals GFR values more accurately reflected disease progression, VA found during its internal review that the renal dysfunction rating criteria proposed in July 2017 contained erroneous values and units of measure for ACR and GFR.
These erroneous proposed values were not in line with the National Kidney Foundation guidelines and would have resulted in erroneous disability evaluations for multiple renal disabilities. In contrast, the October 2019 proposed rule cited corrected GFR
values aligned with the National Kidney Foundations definition and classification of chronic kidney disease.
Natl Kidney Found., KDIGO 2012

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Clinical Practice Guideline for the Evaluation and Management of Chronic Kidney Disease, 31 Kidney Intl Suppl. 5 Jan. 2013, available at https
kdigo.org/wp-content/uploads/2017/02/
KDIGO_2012_CKD_GL.pdf last viewed May 15, 2020 hereinafter KDIGO.
Therefore, VA makes no changes based on this comment.
Another commenter stated that a recent study showed that an overestimation of renal function was correlated with patients postamputation status. The commenter stated that this study suggested that a cystatin C test would be a more accurate measure of kidney function in patients who have had amputations. According to the National Kidney Foundation, a blood test for cystatin C can be helpful in some instances, but it is not the usual or regular way to estimate a GFR.
National Kidney Foundation, Cystatin C, https www.kidney.org/atoz/
content/cystatinC last viewed May 15, 2020. A recently published study examined the accuracy of kidney function estimates when prescribing renally-eliminated medications in nontraumatic amputees. Aakjaer et al., Differences in Kidney Function Estimates Based on Creatinine and/or Cystatin C in Non-Traumatic Amputation Patients and Their Impact on Drug Prescribing, 81 J Clin Med.
89 2019, https www.ncbi.
nlm.nih.gov/pmc/articles/PMC6351924/
last viewed May 15, 2020. The conclusions of this study highlighted the fact that a non-traumatic amputation of a lower extremity has a significant effect on both eGFR and cystatin C.
Furthermore, there are significant differences between eGFR and cystatin C both before and after amputation and these differences impact how renallyeliminated medications should be prescribed. VA appreciates this comment. However, the VA rating schedule for disabilities is not used for diagnosis and treatment of medical conditions; it is used to evaluate disabilities in accord with average earnings loss. VA has determined that, for VA disability evaluation purposes, GFR, eGFR, and ACR values present adequate measurements of functional impairment due to kidney disease. VA
makes no changes based on this comment.
Another commenter disagreed with the changes made in 38 CFR 4.115a by stating that decreasing the required GFR
for the 80, 60 and 30 percent rating criteria would disqualify many veterans with chronic kidney disease from future increases in their disability rating if their conditions worsen. However, VA
did not propose a decrease in GFR

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values; rather, VA replaced subjective terms such as markedly, some, and slight in the current evaluation criteria with specific, objective laboratory findings, such as GFR and ACR. To the extent that the comment was intended to suggest that VA should use the GFR values in the proposed rule published in July 2017 and later withdrawn, VA has determined, as stated above, that the GFR values proposed in October 2019 are more accurate and better aligned with the National Kidney Foundations definition and classification of chronic kidney disease. VA makes no changes based on this comment.
The same commenter was concerned that, under the proposed GFR values, a veteran would have to be at the point of getting a kidney transplant in order to reach an 80 percent disability evaluation. VA proposed an 80 percent evaluation for individuals with a GFR
between 15 and 29 mL/min/1.73 m2 for at least three consecutive months. This aligned VAs functional impairment evaluation with the most current clinical guidelines. Natl Kidney Found., Managing Your Adult Patients Who Have a Kidney Transplant, at 2
2011, available at https
www.kidney.org/sites/default/files/0250-4079_ABB_ManagingTransRecipBk_
PC.pdf last viewed May 15, 2020
hereinafter Managing. According to the National Kidney Foundation guidelines, only patients with kidney failure GFR value <15 or dialysis are considered for kidney replacement therapy kidney transplant. Id. For patients with severely decreased kidney function GFR between 15 and 29 mL/
min/1.73 m2, a referral to a nephrologist for evaluation of chronic kidney disease progression is recommended. Id. Such evaluation would include a range of activities in preparation for kidney replacement therapy such as patient and family education, dialysis access, and preemptive transplant. Id. VA makes no changes based on this comment.
Another commenter referenced a study that showed a link between kidney disease and/or kidney failure and prolonged use of proton pump inhibitors such as Prilosec and Nexium.
The commenter suggested that the overuse and/or prolonged use of proton pump inhibitors during military service and the medications side effects should be included in the schedule for rating disabilities. VA appreciates this comment. The comment appears directed more toward establishment of service connection for a condition resulting in disability than to rating the level of disability attributable to the
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