Still waiting: New dialysis centers struggle with certification delays

For seven years, dialysis has kept Renae Jacobson alive.

A hereditary disease attacked her kidneys, so, three times a week, she drives from her home in southwest Shawnee County to spend four hours at DaVita's dialysis center in St. Francis' Mulvane building in central Topeka, where machines take over the job of removing the waste and excess water from her blood.

"It takes a lot of time," Jacobson said. "I drive almost 25 minutes just to get there - and that's not counting bad weather."

When she heard DaVita was opening a new center at SW 37th and Wanamaker, Jacobson was excited to cut her drive time in half.

"It's important for me to get home and get back in my bed because I don't feel well after that - and most dialysis patients don't," she said.

But Jacobson is still waiting for the shorter drive to become reality. The new building with its 24 dialysis stations continues to sit empty.

Erin Hinrichsen, group facilities administrator for DaVita, said the company never thought it would take this long.

"We were really hoping that within about three months of asking for certification that we would open," she said.

The holdup is an initial survey of the new location, so it can be certified through the federal Centers for Medicare and Medicaid Services (CMS). Those surveys are done through the Kansas Department of Health and Environment, by staff funded through CMS.

DaVita applied for the survey in October 2015. When it was not scheduled by January, they submitted medical necessity paperwork, showing the facility should be given higher priority. CMS denied the request.

On August 19th, KDHE notified DaVita that surveys on the Wanamaker site, along with a new clinic in Kansas City that applied in January and a new clinic in Emporia that applied two years ago, will not happen until at least September of 2017. Without certification, Medicare and most insurance will not cover patients using the facility.

"We have over 40 patients that are interested in dialyzing at this (Wanamaker) facility," Hinrichsen said. "This facility is here and there are so many benefits to them."

Jim Perkins, director of KDHE's health facilities program, says the problem largely lies with federal rules in how his inspectors must prioritize their work, coupled with staffing shortages.

"We certainly understand the concern that (the clinics) have," he said.

Perkins says KDHE currently has 8 inspectors, three of whom are trained to inspect dialysis centers. Their workload is prioritized by a tier system put in place by CMS.

New dialysis facilities are Tier III, the bottom. Tiers I and II are patient complaints and safety investigations, plus targeted surveys of at-risk sites. The inspectors cover not just dialysis centers, but facilities like acute care, rural health, and hospice clinics. CMS rules dictate that no Tier III work can be done until the top tiers are cleared.

Last fiscal year - July 1, 2015 through June 30, 2016 - those top two tiers had KDHE surveyors conducting 171 initial and resurveys, 151 follow-up visits, and looking into 340 complaints, leading to 38 on-site investigations.

"We always send at least two, sometimes three, to a facility that needs to be surveyed so it stretches them out pretty thin," Perkins said.

But even stretched thin, the two-year waits DaVita is facing are outside the norm. KDHE says, for the 15 new dialysis centers opening since 2008, the average wait from application to initial survey was just over seven months. What changed? Perkins cites turnover, plus extra training required to do surveys of dialysis facilities.

"Of the eight (surveyors) that we have now, five of them have come on since the first of the year," he said.

DaVita reached out to Rep. Lynn Jenkins' office to see if they could intervene with CMS on their behalf. Her legislative assistant, Andrew Franke, reached out to KDHE and Perkins in July to see if they could expedite the process.

In response to an open records request, KDHE provided emails and letters further detailing the efforts to increase priority levels of the two clinics. DaVita made the case for the Wanamaker clinic citing easier access for dozens of patients and increased flexibility in scheduling for them. They also included letters from three patients emphasizing the benefits. In addition, for the Emporia clinic, DaVita stated it would be patients' only option for home dialysis services within 60 miles.

In his emails, Franke called the centers "desperately needed."

"I appreciate your review of their already submitted paperwork and would be grateful for the higher prioritization so that our constituents may get the care they need closer to their homes," Franke wrote.

In a reply dated July 20, Perkins told Franke he had discussed the request with CMS.

"As there are no access-to-care issues noted, and given our state required federal workload, the request to have the priority of these facilities raised has been declined," Perkins wrote.

KDHE, through an open records request, also provided the email exchange between Perkins and Julie Metz at CMS regarding Franke's request for additional review of DaVita's priority request.

"I'm ok with you all doing these surveys if you are sure you will get your Tier 1 and Tier 2 work done," Metz wrote on July 18. "If so, I'll approve a priority exception so you all can complete these surveys."

"We are not sure we will get our Tier 1 & 2 work done, in fact it will be very close for us to complete," Perkins replied. "At this juncture I would not be comfortable asking for an exception to the state priority workload."

Perkins says KDHE is working to increase staffing levels and training. He says a fourth person will attend training in February for inspecting dialysis centers.

Hinrichsen says, for DaVita, while there may not be an access to care issue now, the solution is important to meeting future needs.

Centers for Disease Control data shows that, in 1999, no state had a prevalence of End Stage Renal Disease at rate greater than 1800 per million. By 2013, their figures show a majority of states at that level.

KDHE says approximately 3200 people in Kansas are currently on dialysis.

With the numbers of people with diabetes and high blood pressure increasing, it's expected the numbers of people with kidney disease also will go up, as those are both risk factors.

Hinrichsen says DaVita has 180 patients at its current Topeka location on Mulvane. They fit them all in, but she says it's not easy.

"I would say that we are getting close to max capacity. We are still able to add in spots for new patients, leaving little room for patients to move around and change times," she said. "Most start with a time that does not fit their schedule, then go on a wait list to a time that would better accommodate them."

Patients like Jacobson say a little bit of convenience would be nice when living with a disease that's anything but.

"Nobody wants to be on dialysis," she said, "but if they can cut the time by getting here and then getting back home, that would be wonderful."