The regulation, and how many of it we hold
The rulebook is 42 CFR Part 494 — Conditions for Coverage for End-Stage Renal Disease Facilities. Ten of its requirements attach to an individual patient and carry a date. Those ten are what ComplyWell runs.
Each one was read from two independent primary sources — the eCFR current text and the GovInfo annual CFR edition — and had to match word for word before a rule was written.
Every deadline we watch for a dialysis facility
| The deadline, in plain English | What the clock actually is | Citation |
|---|---|---|
| First full assessment done within 30 days or 13 sessions, whichever comes later | The latter of 30 calendar days or 13 outpatient hemodialysis sessions, counted from the first outpatient session. Both limits have to pass. | 42 CFR 494.80(b)(1) |
| Follow-up reassessment within 3 months of the first one | Three calendar months from the date the initial assessment was completed. Counted as real months, not as 90 days. | 42 CFR 494.80(b)(2) |
| Dialysis dose measured every month for hemodialysis patients | Delivered Kt/V, or an equivalent measure, at least monthly. | 42 CFR 494.80(c)(1) |
| Dialysis dose measured every 4 months for peritoneal dialysis patients | Delivered weekly Kt/V, or an equivalent measure, at least every 4 months. | 42 CFR 494.80(c)(2) |
| Stable patients reassessed at least once a year | 365 days since the last comprehensive reassessment. | 42 CFR 494.80(d)(1) |
| Unstable patients reassessed every month | 30 days — applied to a patient your own export has flagged unstable. We do not make that judgment. | 42 CFR 494.80(d)(2) |
| First plan of care started within 30 days or 13 sessions, whichever comes later | The same latter-of window as the initial assessment. The regulation says implementation, so a plan written but not in use has not met it. | 42 CFR 494.90(b)(2) |
| Plan of care updated within 15 days of each new assessment | 15 days from the completion of the assessment that triggered the update. | 42 CFR 494.90(b)(2) |
| A doctor or practitioner sees the patient every month | At least monthly, evidenced by a monthly progress note placed in the medical record. | 42 CFR 494.90(b)(4) |
| Home patients' own records collected and reviewed every 2 months | At least every 2 months, for self-care and home patients only. | 42 CFR 494.100(b)(2) |
Why these are the ones that get missed
The latter-of window catches people out by arithmetic, not by neglect
The clock runs from the first outpatient dialysis session and ends at whichever comes later, so a busy patient can hit 13 sessions long before day 30 and a light one can pass day 30 first. Two patients admitted the same week can have deadlines a two weeks apart. That is not something a calendar reminder can model, and it is the first thing this rulebook gets right.
494.80(b)(1) and 494.90(b)(2)A missing month of Kt/V is the fastest finding a surveyor can write
The gap is visible straight off the lab log. Nobody has to interpret a note or read a chart to see that a month went by without a delivered dose measurement. It is the cheapest citation in the building to earn and the cheapest to prevent.
494.80(c)(1)Four months is long enough that nobody remembers
Peritoneal patients are usually the small group nobody has a routine for, and a four-month interval never lands on the same day of the week or the same point in the month. That combination is how the interval quietly stretches to five.
494.80(c)(2)An assessment that never turns into a changed plan of care
The assessment was done, on time, properly — and then the plan it was supposed to change sat there unchanged. Fifteen days is the whole window, and it starts the moment the assessment is complete.
494.90(b)(2)The proof is the note, not the visit
The regulation names the monthly progress note as the evidence. A practitioner who saw the patient but never wrote the note counts as a miss, and there is no way to argue it after the fact. We follow the interval and the recorded date; we do not read what the note says.
494.90(b)(4)Home patients are out of sight between clinic visits
The two-month retrieval and review of a home patient's own self-monitoring records is the only scheduled check that they are dialyzing safely at all. It is also the easiest thing on this list to defer for two weeks and then forget.
494.100(b)(2)What a condition-level finding actually costs
A condition-level deficiency under Part 494 puts the facility's Medicare provider agreement at risk, and CMS may impose alternative sanctions under 42 CFR 494.180 and Part 488 short of termination.
What ComplyWell does about it
- You send a patient roster. Usually a scheduled export from the system you already run, emailed to us on a recurring basis. That is a setting inside your own software — no integration, no vendor call, and nobody outside your facility gets access to it.
- The engine counts. Every morning, all ten rules run against every patient. It is deterministic date arithmetic against dates from your own records — a subtraction, not a prediction. It cannot invent a deadline the regulation does not create, and it cannot decide a patient is unstable; it reads the stability value your own team recorded.
- One brief goes to the named person. Not a dashboard nobody opens. A short email, each finding sorted into Action due or Past due, and an All clear when there is nothing open. You choose who receives it on the setup page.
- Every finding carries its evidence. Each one names the field and the value from your own export that produced it, and states (empty) explicitly where a field was blank. That is the trail you hand a surveyor, and no finding is raised without one.
- Every brief is dated. The top of the brief names the export it was built from, so you always know exactly how current the numbers are.
Get Your Free Compliance Check
Send us one roster export. We will run all ten Part 494 rules against your own dates and show you exactly what is open today, with the citation and the evidence behind each one — before a surveyor finds it first.
Get Your Free Compliance Check