The regulation, and which version of it
The rulebook is 42 CFR Part 8, Subpart C — Certification and treatment standards, as amended by SAMHSA's final rule Medications for the Treatment of Opioid Use Disorder (89 FR 7528, 2 February 2024). It took effect on 2 April 2024 with a compliance date of 2 October 2024. Seven of its requirements attach to an individual patient and carry a date. Those seven are what ComplyWell runs.
Each requirement was read from two independent primary sources — the eCFR current text and the GovInfo annual CFR edition — and both had to agree before a rule was written. Where only one source could produce the sentence, the requirement was excluded. Nothing here rests on a law firm's summary or a guidance document.
Every requirement we watch for an opioid treatment program
| The requirement, in plain English | What the clock actually is | Citation |
|---|---|---|
| Full medical exam finished within 14 days of admission | 14 calendar days from admission. A patient may start medication after the screening exam, but the full history and physical still has to land inside the two weeks. | 42 CFR 8.12(f)(2) |
| Initial psychosocial assessment and care plan done within 14 days | 14 calendar days from admission, and the assessment has to produce a care plan. | 42 CFR 8.12(f)(4)(i) |
| Care plan carries every required element | No clock — a content check. Goals and agreed actions, education and employment goals, recovery support services, and how often each service will be given. | 42 CFR 8.12(f)(4)(i) |
| Periodic physical examination at least once a year | 365 days since the last one, conducted by an OTP practitioner. | 42 CFR 8.12(f)(4)(ii) |
| Random drug testing keeping pace with eight a year | No fewer than eight random tests per patient per year. We watch the gap since the last test, because eight a year is one about every 46 days. | 42 CFR 8.12(f)(6) |
| Interim patients have a plan for continuing treatment by day 120 | Day 120 of interim treatment, for patients whose status names interim treatment. | 42 CFR 8.12(j)(4)(iii) |
| Interim treatment does not run past 180 days | 180 days. Interim treatment cannot run longer than that in any 12-month period. | 42 CFR 8.12(j)(4)(ii) |
Why these are the ones that get missed
Surveyors pull new admissions first, and these are the dates they look for
Both fourteen-day clocks start on the same day and run out on the same day, in the two weeks when the patient is least settled and the chart is least complete. A late psychosocial assessment does not just sit there either — it makes every later plan review late too, because the whole cycle is anchored to it.
8.12(f)(2) and 8.12(f)(4)The interim clock is a finding a surveyor can read straight off the admission date
Interim treatment is capped at 180 days, and the written plan for what happens afterwards has to be in the record by day 120. Miss the day-120 plan and there is nowhere for the patient to go when the cap arrives. Neither of these requires anyone to open a chart to check — they are arithmetic on a date the program itself recorded.
8.12(j)(4)(ii) and 8.12(j)(4)(iii)The annual physical drifts because nothing prompts it
Long-standing patients pass the anniversary quietly, precisely because nothing about their treatment changed to raise the question. It is the same shape of failure as an annual reassessment anywhere else: not a mistake, an absence of a prompt.
One honest note. The regulation says this examination should occur not less than one time each year, not must. Our brief says the regulation expects one at least yearly. It does not tell you that you broke a rule you did not break.
8.12(f)(4)(ii)Eight tests a year is a total, and a total is how a patient quietly ends the year short
The rule sets a yearly minimum, not a fixed gap, so nobody notices the shortfall until the year is nearly over and there is no time left to fix it. We watch the pacing instead: a gap wider than about six weeks is how a patient ends up at six tests instead of eight.
8.12(f)(6)What is actually at stake
Under Part 8 Subpart C, SAMHSA can suspend or revoke a program's certification. For an opioid treatment program that is not a financial penalty to be absorbed — it is the ability to dispense methadone, which is the business. State licensure action and Medicaid recoupment usually follow the same findings.
What ComplyWell does about it
- You send a patient roster. Usually a scheduled export from the dispensing or clinical 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 program gets access to it.
- The engine counts. Every morning, all seven 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.
- One brief goes to the named person. A short email to the program director or compliance officer you nominate, each finding sorted into Action due or Past due, and an All clear when there is nothing open.
- Every finding carries its evidence. Each one names the field and the value from your own export that produced it, including the status field it read to decide whether a patient counts as interim, and states (empty) explicitly where a field was blank.
- 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 seven Part 8 rules against your own dates and show you exactly what is open today, with the current citation and the evidence behind each one.
Get Your Free Compliance Check