Editorial - Dr. Ajay K. Singh
One point that has been made is that adding another
regulatory agency overseeing dialysis is further intruding the federal
government into something that should be governed by the
doctor-patient relationship. This argument echoes the feelings of
conservatives that we are steadily losing our autonomy to an
interfering federal bureaucracy. I can see how this argument might resonate,
but offer an alternative view. Currently, how much autonomy do you think a
dialysis patient has? Ask the question about how likely is it that a dialysis patient might be able to get additional treatments or increase time from 4 to 5
hours for each treatment? The point is that dialysis has become commoditized
with a “one-size-fits-all” approach. Patient’s are anointed to a
“Monday-Wednesday-Friday or Tuesday-Thursday-Saturday shift for up to 4 hours
each and told “please don’t deviate from this”. The idea of having the FDA
intrude is to make sure that if the evidence supports more dialysis, as I believe that it does, then more dialysis should be offered. No one can force a dialysis patient to receive more frequent dialysis or
longer dialysis, but surely if evidence shows that more dialysis is the best
approach we should be able to offer it to patients?
The second point, somewhat related to the one above, is that
CMS already oversees dialysis in the United States. Why add a second regulatory
agency? It is true that CMS pays for dialysis care for hundreds of thousands of
Medicare beneficiaries. As well, using the measures developed by the National
Quality Forum and others, CMS incentivizes quality, or at least it thinks it does. Lately, these have been incorporated into QIPs (see my earlier post on
this here). However, I would suggest that CMS squandered a golden opportunity to appropriately set patient-centric
quality measures. One could reasonably question whether CMS's quality measures are patient centric -- some are, but not all. For example, is measuring how
frequently quality of life questionnaires’ are administered patient-centric? (see an earlier post on this). The fact
is that CMS could do better in its oversight of dialysis quality.
Examples include epo dosing, its assessment of dialysis unit hygiene (see
Atlantic magazine article by Robin Fields, “God Help You. You're on Dialysis.”) to name just two.
The third category of comment is that my push for the FDA as
an enabler for more dialysis would just result in over-dialysis -- like the situation with epo prior to the FDA black box. As someone who
has been “out there” as a forceful critic of the excesses of epo dosing I would
respectfully draw a distinction between epo dosing practices and the dosing of
dialysis. The current dose of dialysis represents a minimally acceptable dose of dialysis -- a GFR
equivalent of 5 to 10 ml/min. Prescribing more dialysis is really demanding
more clearance of waste products and better control of volume. It represents
proven reduction in the use of various medications (antihypertensives, ESAs and
vitamin D analogues).
The bottom line is that the current system needs improvement. The FDA as a federal agency, while not
perfect, has a storied history of protecting patients. I still remain a believer
in the FDA taking on the regulation of dialysis dose, frequency, and duration. Whether anyone is paying attention to this view is, of course, another matter.
