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Federal Register / Vol. 86, No. 213 / Monday, November 8, 2021 / Rules and Regulations
to issue referrals for kidney disease patient education services.
Response: As required under 42 CFR
410.48b2, Medicare Part B covers kidney disease patient education services only if the beneficiary obtains a referral from the physician managing the beneficiarys kidney condition. We did not consider issuing a waiver to broaden the categories of clinicians who could issue referrals for kidney disease patient education services in the CY
2022 ESRD PPS proposed rule.
Moreover, we currently have no evidence to suggest that the waiver suggested by the commenters would be necessary solely for purposes of testing the model, as would be required to issue such a waiver under section 1115Ad1
of the Act. In addition, we do not currently have, and no commenter provided, evidence that broadening the categories of clinicians who could issue a referral for kidney disease patient education services would continue to ensure clinical appropriateness. As such, we will continue to require that the physician managing the beneficiarys kidney condition refer a beneficiary for kidney disease patient education services in order for Medicare to pay for such services as required under 42 CFR 410.48b2. However, we will continue to consider the commenters suggestions, and we may consider broadening the categories of clinicians who may issue a referral for kidney disease patient education services in future rulemaking.
Final Rule Action: After considering public comments, we are finalizing our proposal to make conforming and clarifying changes to our regulation at 512.397b, without modification.
After considering public comments, we will not be altering the curriculum for kidney disease patient education services or allowing any additional types of Medicare providers or suppliers to furnish and bill kidney disease patient education services beyond clinical staff and qualified staff at this time.

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C. Requests for Information on Topics Relevant to the ETC Model 1. Peritoneal Dialysis Catheter PlacementRequest for Information RFI
Through the CY 2022 ESRD PPS
proposed rule 86 FR 36395, we sought input on how we can test and use Medicare payment policy, under the ETC Model, to promote placement of PD
catheters. Specifically, we sought feedback on the following questions:
a. What are the key barriers to increased placement of PD catheters?

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b. How can CMS promote placement of PD catheters in a more timely manner?
c. Should the Innovation Center use its authority to test alternative payment structures to address the barriers to PD
catheter placement as a part of the ETC
Model? If so, why and how?
For the complete discussion of this RFI, see the CY 2022 ESRD PPS
proposed rule, 86 FR 39395 through 39396.
Comments: Commenters expressed general concern that CMS continues to address barriers to home dialysis one provider type at a time rather than holistically as an extended series of barriers and decision points that patients face beginning when they are in earlier stages of kidney disease.
Most commenters agreed with the main barriers to PD catheter placement described in the RFI, including the lack of availability of hospital-based catheter insertion teams to perform PD catheter placements, lack of appropriate operating room time, and a lack of training on PD catheter placement for vascular surgeons. But the commenters suggested additional barriers for CMSs consideration.
First, commenters noted that the COVID19 pandemic has limited the ability of health care providers to perform elective procedures on a timely basis. According to the commenters, hospital operating rooms effectively halted PD catheter implantation in many hospitals for several months.
Rural facilities were particularly hit because these communities rely on surgeons who travel in from larger communities and have limited availability. One commenter noted that incentivizing, or disincentivizing, providers through payment changes or Innovation Center models would not fix the core issue for rural dialysis facilities unless there are enough scheduled patients to make a trip financially feasible. This commenter suggested that as an alternative, CMS should consider methods to reduce the prevalence of ESRD in the long term with a specific focus on rural areas. While this approach may not create immediate savings, reducing the rate of ESRD
would significantly benefit CMS in the years to come.
A commenter noted that many of the candidates for prospective PD catheter placement are either not yet eligible for Medicare or are uninsured, and that there is little incentive for hospitals or other facility settings to address the lack of availability of vascular surgeons to perform PD catheter placements, lack of appropriate operating room time, and a lack of training on PD catheter
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placement for vascular surgeons.
Another commenter noted a concern regarding the number of physicians trained to perform PD catheter placement as many of the more experienced PD catheter physician providers are in the later stages of their careers and there are not replacement providers in the pipeline when they retire.
The majority of commenters mentioned the largest barrier for PD
catheter placement is low reimbursement, making it difficult to encourage new surgeons and other physicians to become adept at PD
catheter implantation. One commenter specifically mentioned that many of the standalone vascular access centers have closed because of the reduction of CMS
payments to vascular access surgeons.
Unlike the transplant surgeons, who may be incentivized to increase rates of transplantation through increased revenue resulting directly from increasing the number of transplants performed, there are no other direct or indirect incentives for vascular surgeons or vascular access centers to increase rates of, PD catheter placements that can work outside the model to address these concerns. Accordingly, commenters suggested that it would be appropriate to create a separate PD catheter placement incentive under the ETC
Model.
As the ETC Model currently seeks to change payment incentives only for ETC
Participants ESRD facilities and Managing Clinicians in Selected Geographic Areas and, doesnt provide direct incentives for vascular access surgeons to work with ETC Participants, commenters strongly urged CMS to thoughtfully consider to what extent ETC Participants can influence increased rates of PD catheter placement. Despite the importance of dialysis access procedures to patients, commenters noted that ETC Participants currently have little influence on surgeons and hospitals performing dialysis access procedures in a fee-forservice structure. This factor limits the ability of ETC Participants to increase home dialysis utilization, which is contingent on timely and high-quality PD catheter placement. Commenters also urged CMS to consider establishing an incentive payment of at least $360.62
to surgeons and other access specialists in the ETC Model to achieve this goal.
Several commenters suggested that a voluntary track or option could be added to the ETC Model under which ETC Participants would receive a payment increase per PD placement of at least an additional $360.62 per PD
catheter procedure to equalize the
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