Group asks CMS to allow manufacturers, non-nursing staff to provide home dialysis training
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An advocacy group wants CMS to update regulations to allow dialysis machine manufacturers and non-nursing personnel to provide home dialysis training.
The changes, detailed in a position paper released by Innovate Kidney Care (IKC), are directed at the Conditions for Coverage, a set of federal rules dialysis providers must follow to receive Medicare reimbursement for patient care.
CMS last revised the regulations in 2008.
Members of IKC include health plans and dialysis equipment manufacturers, as well as the National Kidney Foundation and the American Society of Nephrology.
In interviews with Healio Nephrology, IKC members said the update is needed to give dialysis providers more flexibility in providing home dialysis training.
“In the past, before the Prospective Payment System for the End-Stage Kidney Disease Program was put into place, dialysis device manufacturers used to bill CMS directly under what is known as Method II, but that no longer exists,” Tonya Saffer, vice president of government affairs and market access for Outset Medical, said. “Therefore, the outdated Conditions for Coverage language referencing a prohibition on DME suppliers doesn’t make sense but may lead surveyors and providers to conclude that home dialysis technology companies can’t participate in training patients for home.
“Allowing manufacturers to provide expertise to patients on their dialysis machine could help alleviate the nurse staffing shortage,” Saffer said. “We can’t expect a home dialysis nurse to be an expert on every new dialysis machine.”
Nursing shortage
Saffer and other IKC members who authored the position paper said much of the need for change is based on a “rapidly increasing” shortage of nurses.
“ ... The outlook for nephrology nurses is especially troubling,” the authors wrote. “According to the [U.S. Renal Data System] USRDS and the Chronic Kidney Disease Surveillance System, the number of full-and part-time dialysis center staff in the U.S. has shown an increase from 2017 to 2018. However, as noted in the American Journal of Kidney Diseases Policy Forum, approximately 5% to 7% of nursing positions have remained unfilled at outpatient dialysis facilities since 2004.
“High turnover is problematic because competent nephrology nurses require between (3) and (9) months of additional experience,” the authors wrote. “In addition, existing regulations require that nurses conduct home dialysis training, leading to the interpretation that the nurse must deliver all aspects of training, despite other care team members having applicable skills and training.
“This situation places an additional burden on nurses, making the shortage an additional challenge for expanding home dialysis.”
The position paper recommends a nurse continue to supervise home training. CMS should “remove the requirement that RNs ‘conduct’ the training, replacing it with ‘having more oversight and participation by a[n]’ RN who can then determine readiness,” according to the paper.
“We must expand beyond only registered nurses for training and support them by sharing responsibilities with other members of the care team and the patients, to meet market demand and to reduce the burnout RNs face.”
Miriam Godwin, public policy director for the NKF, told Healio Nephrology the kidney community needs to find ways to identify new staffing sources for home dialysis training to increase use of the therapy.
“We have this huge problem with a shortage of nephrology nurses, and the pandemic exacerbated the problem,” Godwin said. “It’s frustrating because there aren’t any easy solutions.
“But I think we have to be practical about this. Staff, like social workers and patient care technicians who have expertise in cannulating patients, can play a vital role in helping to train patients. If we want to grow home, we need to leverage all these professionals.”
Industry involvement
The position paper also proposes device manufacturers be allowed to provide patient education. “CMS should permit home dialysis device manufacturers to directly train patients, under the oversight of the dialysis facility nurse,” the authors wrote. “As more new machines come to market, it is imperative that manufacturers be able to train patients on how to use such machines.”
The position paper also advocates nephrologists disclose any affiliations they have with device manufacturers and their ownership status with specific dialysis providers. “CMS should require qualified facilities to disclose to CMS and patients all individuals and entities with a financial interest in the facility, facility subsidiary and joint venture partnerships that it or its subsidiaries are a party to.
“This reporting to CMS should include the National Provider Identifier (NPI) of such individuals, and also the NPI for any providers that are party to such an entity, and the information should be updated annually,” the authors wrote. “CMS should also commit to perform a detailed analysis of the updated information annually.
“Medical directors who have clinical and quality oversight of the dialysis clinic should also be listed publicly within the facility and on the CMS Dialysis Facility Compare website,” the authors wrote.
The complete report is available at www.innovatekidneycare.com.
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Healio Interview
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