Who needs to approve self dialysis?

By Bill Peckham

Can/should people dialyze alone? Who makes the determination? I believe that it should be the decision of the person doing dialysis in consultation with their doctor. However, dialysis providers operate in a regulatory intensive environment and have to follow both federal and state regulations.

The Centers for Medicare and Medicaid Services has pages of dialysis provider regulations called the Conditions for Coverage (CfC). The CfCs don't speak to the need for a trained partner for home hemodialysis but states can have their own regulations that are in addition to the CfCs. Anna famously had issues (I would have driven supplies to her had it become necessary) and indeed the State of New York has their own regulations . These I think are the relevant State of New York regulations regarding home dialysis, Section 757.2 (my emphasis):

OFFICIAL COMPILATION OF CODES, RULES AND REGULATIONS OF THE STATE OF NEW YORK
TITLE 10. DEPARTMENT OF HEALTH
CHAPTER V. MEDICAL FACILITIES
SUBCHAPTER C. STATE HOSPITAL CODE
ARTICLE 6. TREATMENT CENTER AND DIAGNOSTIC CENTER OPERATION
PART 757. CHRONIC RENAL DIALYSIS SERVICES
Text is current through February 29, 2008.Section 757.2.

General requirements.
The operator shall comply with the following requirements:

(a) A physician or a registered professional nurse who has had at least three months of training and experience in hemodialysis under the close supervision of a qualified physician, shall be in attendance at all times during the provision of hemodialysis services by center or facility staff to patients at home; provided, however, that upon the certification of the medical director that the patient's condition is sufficiently stable, a licensed practical nurse with equivalent training and experience may attend a patient during dialysis treatment at home.

(b) Provision of chronic hemodialysis service in the home, by a patient and/or the patient's assistant shall be based on a recommendation for such home treatment as a result of the coordinated evaluation of each patient's treatment in an approved center or facility and after the patient and the assistant have been properly trained at an approved center or facility. The center or facility assumes the responsibility to supervise the patient's home treatment and to act as backup for the patient's emergency needs.

(c) Provision of chronic renal dialysis services in a patient's home by center or facility staff shall be based on a recommendation for such home treatment as a result of the coordinated evaluation of each patient's treatment in an approved center or facility and the recommendation of the patient's physician. The center or facility shall assume the responsibility to provide the patient's home treatment and to act as a backup for the patient's emergency needs. In addition to the specific requirements of this Chapter, chronic renal dialysis shall be provided by an approved center or facility in a patient's home in accordance with generally accepted standards of professional practice.

(d) Approved centers or facilities treating pediatric patients, on other than emergency basis, must have the consultation services of a qualified pediatric nephrologist.

(e) Approved centers or facilities shall furnish all types of home dialysis training and supervision either directly or under an agreement or by arrangement in writing with another center or facility.
... [continues with water quality guidance]

The problematic language are the highlighted phrases in section (b). From a strict reading one might conclude that the state of New York is specifying that someone on dialysis can be a passive participant in their care but they can not be the only person responsible for their care.That is not an optimal framework.

It isn't clear what the rule writers had in mind. Is the intent of the language to take a position on self dialysis? Or rather is it describing current practices when the rule was written? It is my guess that the rules are based on the dialysis of yesteryear. These dialysis regulations need to be revisited by the State of NY Department of Health to reflect modern dialysis machines and the clinical stability that comes from more frequent hemodialysis. Access to high dose dialysis should not depend on a willing helper. Adults, even adults with CKD5, should, in consultation with their doctor, be left to make their own decisions about how to meet their renal replacement needs.

Comments

[Tracy Lynn]

This was an issue when I wanted to home dialyze in Maine. The Fresenius clinic I was at only allowed people to do it with a partner, and Medicare won't pay for that.

After a few months at home, I have to admit that I am kind of angry about that. I spent four years doing in center and feeling like crap, having no life, and all because of some arbitrary decision by people who had never met me. Bastards.

[Zach]

Here in New York City, The Rogosin Institute has a Home Nocturnal Hemodialysis program where the patient can be alone. The treatment is monitored via the internet by a nurse at Rogosin.

http://www.rogosin.org/treatment-home-nocturnal-hemodialysis.php

[Anna Bennett]

Rogosin is a great center. I had a long conversation with the Home Hemo Nurse back in September when I got dumped by DaVita.

Unfortunately, they didn't use NxStage at the time, and the solo home option I was told was for Nocturnal only. I am very curious about this suitcase home hemo that I have been hearing about out of Rogosin. I can't wait until they publish something about that.

[Bill Peckham]

Zach I think the way the regulation is interpreted it is either (a) or (b). The remote monitoring puts the home treatment under (a).

What would be interesting is to hear how the remote monitoring has helped in a situation. To hear that but for the remote monitoring, ____ would have happened.

Anna my question is: how big is the suitcase? My grandparents use to travel with steamer trunks ... you could probably fit a Baby K in one of those.

[Anna Bennett]

Well, I travel with a little red backpack and a laptop - so, fingers crossed that the machine designers were thinking of me and not your Grandparents. (although I really could get used to traveling with steamer trunks, white linen and oysters... well, maybe not oysters)

[Zach]

Unfortunately, some at Rogosin refer to the NxStage System One as the "suitecase" home hemo.

[Rich Berkowitz]

Now that I've read the provision, I have even more questions as why Anna wasn't allowed to go solo.

The language of the provision can be construed as pretty fuzzy. In the clause "by a patient and/or the patient's assistant" it isn't made definite that a patient MUST have an assistant. The second statement in question of "patient and the assistant have been properly trained" only says that the patient and assistant, if there is one, shall be properly trained.

Also, how can one then jump to the ability of having a patient being monitored remotely replace having a physical assistant as Bill suggests. Oh, they can call 911! Gimme a break! What if quicker action is required!

As a solo home dialyzor, I've taken responsibility for my life. I've decided to take the risk to gain the greater benefit. It's no different than if I try to run across a busy highway to get to the other side. OK, that's illegal and maybe not the perfect analogy, but it's my life.