Prior authorization for biologic medicines
Biologic requests are among the most detailed a clinic writes. Reviewers expect proof that the diagnosis is established, that disease activity is significant on a validated measure, that conventional therapy was tried at an adequate dose for long enough, and that the patient has been screened for infection risks. Missing any one of these is enough to pend the request.
What reviewers typically require
Criteria differ by condition and by drug, but the building blocks repeat across rheumatology, dermatology and gastroenterology. Most reviews follow a step approach: a conventional systemic treatment first, and a biologic when that has failed, is not tolerated or is contraindicated.
- Confirmed diagnosis, with how it was made: serology, imaging, biopsy, endoscopy or specialist assessment.
- Current disease activity on a validated score for the condition, for example a joint activity score in rheumatoid arthritis, body surface area and severity index in psoriasis, or an endoscopic and clinical activity index in inflammatory bowel disease.
- Each conventional therapy tried: drug, dose reached, start and stop dates, and the reason it stopped.
- Safety screening before starting: tuberculosis screening and hepatitis B serology with dates and results, and vaccination status where relevant.
- The specific biologic, dose and frequency, and whether the request is initial or a continuation.
- Prescriber specialty, where the criteria restrict who may initiate treatment.
Continuation requests are different
Renewal requests are judged on response. The reviewer wants the baseline score from the initial request and the current score, measured the same way, showing a meaningful improvement. A renewal letter that only says the patient is doing well is weak; one that says the activity score fell from 5.6 to 2.9 over six months, with steroids stopped, is strong.
Keep the baseline measures in the note at the start of treatment. They are much harder to reconstruct later.
Example
Request: Initiation of a TNF inhibitor. Diagnosis: Rheumatoid arthritis with rheumatoid factor of multiple sites without organ or systems involvement (M05.79). [Patient initials], 44, diagnosed 18 months ago; rheumatoid factor and anti-CCP antibodies positive; erosions at two MCP joints on hand radiographs. Conventional therapy: - Methotrexate, escalated to 20 mg weekly with folic acid, 7 months. Stopped for persistent nausea despite a switch to subcutaneous dosing. - Sulfasalazine 2 g daily, added and continued for 4 months. Inadequate response. Current activity: 9 tender and 7 swollen joints, CRP 24 mg/L, composite activity score in the high range. Morning stiffness 2 hours; unable to work full shifts. Screening: interferon-gamma release assay negative; hepatitis B surface antigen and core antibody negative (both within the last month).
Where biologic requests fall down
| Gap in the request | What to add |
|---|---|
| Prior therapy named without dose or duration | Maximum dose reached and the number of months at that dose |
| Intolerance stated vaguely | The specific adverse effect and what was done about it before stopping |
| No activity score | The validated measure used in the clinic, with its components |
| Screening missing or undated | Test name, result and date |
| Renewal without baseline | The starting score from the initial request alongside today's |
ClearPass drafts the biologic justification from the clinic note, adds the ICD-10 codes, and asks you for anything the reviewer is likely to check that the note leaves out, such as a screening date. You choose Concise, Standard or Detailed and edit the result. If a request has already been refused for missing prior therapy, Rejection Analysis can produce a Targeted Fix that addresses only that point.
What ClearPass does not do
- It does not replace your judgement. Every note is an AI draft that you review and correct before it is used.
- It is not a medical device and does not make clinical decisions. It is a documentation aid.
- It does not connect to your EMR. The note is copy-ready text that pastes into any system.
Privacy
Clinical note content is not stored on ClearPass servers: it is processed to write the note, then discarded. Consultation audio is transcribed and discarded, never stored. Your note history stays in your browser, on your device, and you choose how long it is kept. Common identifiers are removed from typed and transcribed text before it reaches the AI; that is a best-effort safeguard, so leave names, ID numbers and file numbers out where you can. Processing goes through the AI providers named in our Privacy Policy, which sets out exactly what each one receives and how long it keeps it. ClearPass does not sign HIPAA business associate agreements today.
Questions
Does ClearPass know each payer's step therapy rules?
Only for the one country where it holds a rules pack. Elsewhere it argues clinical necessity from the documented treatment history without citing a payer's step rules.
Can it calculate the disease activity score?
It uses the scores and components written or said in the visit. Calculate and document the score in the note, and the letter will carry it.
Which specialties does this cover?
Any specialty that prescribes biologics, including rheumatology, dermatology, gastroenterology, respiratory medicine and allergy. Guided templates exist for 19 specialty groups; others use free text and the note structures.
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