Group asks CMS to allow manufacturers and non-nursing staff to provide home dialysis training

March 14, 2022

3 minute read


Disclosures: Schaeffer declares to be an employee of Outset Medical. Godwin claims to be an employee of the NKF.

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An advocacy group wants CMS to update regulations to allow dialysis machine manufacturers and non-nursing staff to provide dialysis training at home.

The changes, detailed in a position paper released by Innovate Kidney Care (IKC), relate to terms of coverage, a set of federal rules that dialysis providers must follow to receive Medicare reimbursement for patient care.

CMS last revised the regulations in 2008.

IKC members 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 was needed to give dialysis providers more flexibility in home dialysis training.

Tonya Schaeffer

“Based on current regulations, we are a supplier of durable medical equipment under a plan called Method II,” Tonya Schaeffer, vice president of government affairs and market access for Outset Medical, said. “Method II prohibits manufacturers from participating in training.” Outset Medical manufactures the Tablo dialysis machine.

Dialysis providers no longer use the Method II payment plan because CMS consolidated all dialysis payments for home and center dialysis in 2011 – but this remains within the regulations.

“Allowing manufacturers to provide patient expertise on their dialysis machine could help alleviate the nursing shortage,” Schaeffer said. “We can’t expect a home dialysis nurse to be an expert on every new dialysis machine.”

Shortage of nurses

Schaeffer and other IKC members who wrote 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 particularly troubling,” the authors wrote. “According to [U.S. Renal Data System] USRDS and the Chronic Kidney Disease Surveillance System, the number of full-time and part-time employees of dialysis centers in the United States increased from 2017 to 2018. However, as reported in the American Journal of Kidney Diseases Policy Forum, approximately 5% to 7% of nursing positions have remained vacant in ambulatory dialysis facilities since 2004.

“High turnover is problematic because competent nephrology nurses require between (3) and (9) months of additional experience,” the authors wrote. “Additionally, existing regulations require nurses to provide training in home dialysis, suggesting that the nurse should provide all aspects of training, even if other members of the care team possess the applicable skills and training.

“This situation places an additional burden on nurses, making the shortage an additional challenge for the expansion of home dialysis.”

The position paper recommends that a nurse continue to supervise home training. The CMS should “remove the requirement that RNs ‘lead’ the training, replacing it with ‘having more oversight and participation by a[n]’RN who can then determine readiness’, according to the newspaper.

“We need to go beyond just RNs for training and support them by sharing responsibilities with other members of the care team and patients, to meet market demand and reduce burnout. faced by AIs. »

Miriam Godwin, director of public policy for the NKF, told Healio Nephrology that the kidney community must find ways to identify new sources of personnel for home dialysis training to increase utilization of the therapy.

“We have this huge shortage of kidney nurses, and the pandemic has exacerbated the problem,” Godwin said. “It’s frustrating because there are no easy solutions.

“But I think we have to be practical about it. Staff, such as social workers and patient care technicians who have expertise in cannulation of patients, can play a vital role in helping educate patients. If we want to grow at home, we have to take advantage of all these professionals. »

Industry involvement

The position paper also proposes that device manufacturers be allowed to provide patient education. “CMS should allow home dialysis machine manufacturers to train patients directly, under the supervision of the dialysis facility nurse,” the authors wrote. “As new machines come to market, it is imperative that manufacturers are able to train patients in the use of these machines.”

The position paper also advocates that nephrologists disclose any affiliations they have with device manufacturers and their ownership status with specific dialysis providers. “CMS should require qualified establishments to disclose to CMS and patients all persons and entities with a financial interest in the establishment, the establishment’s affiliate, and joint venture partnerships to which it or its affiliates are a party.

“This report to CMS must include the National Supplier Identifier (NPI) for such individuals, as well as the NPI for all suppliers who are part of such an entity, and the information must be updated annually,” they said. writes the authors. “CMS should also commit to performing a detailed analysis of updated information every year.

“Medical directors who have clinical and quality oversight of the dialysis clinic should also be publicly listed within the facility and on the CMS Dialysis Facility Compare website,” the authors wrote.

The full report is available at

Jennifer C. Burleigh