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Federal Register / Vol. 86, No. 129 / Friday, July 9, 2021 / Proposed Rules
dialysis unit coordinator. We have also received recommendations that additional columns be added to this section of the cost report to differentiate pediatric home dialysis and in-facility dialysis.
With regard to pediatric supplies and equipment, stakeholders have suggested that there be clear differentiation of supplies used in dialysis treatment of pediatric patients, which vary in type and size, from those used with adult dialysis patients. Stakeholders have further indicated that there is added cost involved with the stocking of the range of sizes and types of supplies needed for this population. Categories of supplies for which there is a significantly increased cost for the pediatric population include: Dialyzers, catheter kits, fistula needles, saline flushes, monitors for vitals, blood pressure cuffs and items used to occupy children during their treatment.
Pediatric nephrologists have noted that these suggested revisions would have the greatest impact on the hospital cost report, which currently does not differentiate pediatric from adult dialysis patients. Approximately twothirds of pediatric dialysis treatments take place in the hospital or medical center setting.

reports include additional specific items for pediatric supplies or a separate section for supply costs associated with pediatric dialysis?
++ To what extent can providers differentiate dialysis labor costs for adult versus pediatric patients?
Are there potential revisions that could be made to the cost report, other than those described above, that would help identify costs unique to the pediatric population for example, revisions to items and services being reported; format revisions to help facilitate reporting on pediatric costs?
What obstacles do providers face in reporting pediatric specific costs of dialysis treatment? How can these obstacles be overcome?
Pediatric dialysis patients comprise a small number of patients in ESRD
facilities other than childrens hospitals or medical centers. How can pediatric dialysis costs be reported in nonspecialized ESRD facilities that predominantly serve adult patients without undue burden on the provider?

3. Request for Information on the Pediatric Cost Report CMS invites comments on the potential changes to cost reports, described previously in this section of the proposed rule, as these changes if proposed and finalized in the future would apply to ESRD facilities treating pediatric dialysis patients. In addition to any other input the public wants to provide regarding the cost reports, we are requesting responses to the following questions.
What degree of specificity is needed in the reporting of pediatric dialysis costs?
Are there dialysis supply costs associated with the treatment of pediatric patients that cannot be reported currently on the cost reports?
If so, please specify.
For ESRD facilities that administer dialysis to both adult and pediatric patients:
++ To what extent can ESRD facilities differentiate dialysis supply costs for adult versus pediatric patients?
Are there specific high-cost supplies unique to the treatment of pediatric patients that could be used to isolate additional costs related to pediatric dialysis?
When differentiating pediatric dialysis supply costs on the cost reports, would providers prefer that the cost
On June 29, 2015, the TPEA was enacted. In the TPEA, Congress amended the Act to include coverage and provide for payment for dialysis furnished by an ESRD facility to an individual with AKI. Specifically, section 808a of the TPEA amended section 1861s2F of the Act to provide coverage for renal dialysis services furnished on or after January 1, 2017, by a renal dialysis facility or a provider of services paid under section 1881b14 of the Act to individuals with AKI at the ESRD PPS base rate, as adjusted by any applicable geographic adjustment applied under section 1881b14DivII of the Act and may be adjusted by the Secretary on a budget neutral basis for payments under section 1834r of the Act by any other adjustment factor under section 1881b14D of the Act. In CY 2017
ESRD PPS final rule 81 FR 77870
through 77872, we finalized the AKI
dialysis payment rate.

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I. Modifying Site of Services Provided to Medicare Beneficiaries With Acute Kidney Injury AKI
1. Background on Medicare Payment for AKI

2. Current Issues and Stakeholder Concerns Over the years, we have received several comments, including concerns from ESRD facilities; national renal groups, nephrologists and patient organizations; patients and care partners; manufacturers; health care systems; and nurses regarding the site of
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renal dialysis services for Medicare beneficiaries with AKI. A patient advocacy organization supported the proposal in the CY 2017 ESRD PPS
proposed rule to adjust the AKI
payment rate by only the geographic and wage indices, and stated that some patients with AKI can safely dialyze at home and have their urine and blood tests performed for the assessment of kidney function in a location closer to home. The organization recommended that home training be paid separately, without dollars removed from the base rate. In the CY 2017 ESRD PPS final rule, we finalized several coverage and payment policies in order to implement subsection r of section 1834 of the Act and the amendments to section 1881s2F of the Act, including the payment rate for AKI dialysis 81 FR
77866 through 77872. We interpreted section 1834r1 of the Act to mean the amount of payment for AKI dialysis services is the base rate for renal dialysis services determined for such year under the ESRD base rate as set forth in 413.220, updated by the ESRD
bundled market basket percentage increase factor minus a productivity adjustment as set forth in 413.196d1, adjusted for wages as set forth in 413.231, and adjusted by any other amounts deemed appropriate by the Secretary under 413.373. We codified this policy in 413.372 and finalized a CY 2021 payment rate for renal dialysis services furnished by ESRD facilities to individuals with AKI
as $253.13 85 FR 71399.
In the CY 2017 ESRD PPS final rule, we stated that we do not expect that AKI
beneficiaries will dialyze at home 81
FR 77871. We affirmed in the CY 2017
ESRD PPS final rule that payment will only be made for in-center peritoneal dialysis or hemodialysis treatments for AKI beneficiaries. CMS also stated in the CY 2017 ESRD PPS final rule that we would monitor this policy to determine if changes are necessary in the future, understanding that there may be a subset of patients for whom AKI
dialysis at home is an appropriate treatment. Currently, CMS continues to believe that this population requires close medical supervision by qualified staff during their dialysis treatment.
Due to the COVID19 PHE and an increase in the number of hospitalized patients with AKI receiving peritoneal dialysis, stakeholders have raised concerns about patients with AKI
having to both travel to, and be present in, an ESRD facility post hospitalization.
CMS received comments that patients with AKI require more vigilant monitoring, particularly in infection prevention, blood pressure
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