While more skilled nursing facilities are using home dialysis to diversify their offerings to patients, New York State’s Department of Health has introduced a new licensing model — with more regulatory steps for operators to complete.
Dialysis services have been identified as a potential area of growth under the new Patient Driven Payment Model (PDPM); in July, the Centers for Medicare & Medicaid Services (CMS) rolled out the End-Stage Renal Disease (ESRD) Treatment Choices (ETC) model, a plan that would boost reimbursements for dialysis treatments.
Marquis Health Services, for instance, earlier this month teamed up with Compass Home Dialysis to provide bedside hemodialysis services at Providence Rehabilitation Center in Yeadon, Pa.
But New York State has stepped in to further regulate the skilled nursing hemodialysis industry — the first state to do so since PDPM October 1 — with a formal certificate-of-need process.
The National Law Review initially reported the news Thursday.
In a letter dated September 25, New York’s DOH calls for SNFs to submit a Limited Review Application (LRA) to add the hemodialysis or bedside hemodialysis category to their operating certificates.
The licensure process calls for the following steps, according to the DOH letter:
• Nursing homes submit a LRA through the New York State Electronic Certificate of Need (NYSECON) system to add Hemodialysis or Bedside Hemodialysis to the nursing home operating certificate.
• The nursing home must create an agreement with an end-stage renal disease (ESRD) treatment provider with an established location. This provider must be federally certified in home hemodialysis training and support, with a state license — and if they don’t have it, the provider must submit an LRA to be state licensed in nursing home hemodialysis.
• If the nursing home is only carrying out bedside hemodialysis, the DOH may ask the provider to complete a survey. Further approval will be based on reviewing the agreement between the nursing home and the ESRD provider. Additional policies and procedures, along with environmental checklists, are part of the approval process.
• If the LRA is for the building a treatment room, in addition to a review of the materials uploaded through NYSECON, approval is conditional and based on a pre-opening survey at the location. A separate LRA must be submitted for any added treatment rooms or dens in the same facility.
This process could create roadblocks for operators looking to expand the services in their facilities, according to Concerto Renal Services executive vice president and general counsel Kyle Stone. Concerto offers dialysis at a host of skilled nursing facilities.
“We are left with questions and concerns,” Stone told SNN. “Concerto welcomes the opportunity to have a dialogue with any state wishing to better understand ways to regulate and understand nursing home dialysis, but it’s an undeniable and sad reality that New York’s new requirements will limit and delay New York’s nursing home patients the ability to dialyze in place. It is also undeniable that this new guidance will add more restrictions for providers.”
ESRD providers in New York nursing homes are further restricted to only provide bedside services for two patients per room. In a den setting, providers still are allowed to serve four patients per room.
“It is in an operator’s incentive to welcome dialysis services, but they will be reduced because of these treatment caps,” he added.