Insights
Weight loss and semaglutide
Compounded GLP-1s, a moving litigation climate, and what underwriting now asks for that it did not ask for two years ago.
What changed
The class grew faster than its documentation
A very large number of practices added prescription weight loss in a short window. Underwriting did not object to the growth. It objected to how thin the files were.
The questions now arriving on submissions are not about whether a practice offers GLP-1s. They are about sourcing, screening, monitoring and what happens when a patient has an adverse reaction at home.
A practice that can answer those four in writing is in a different conversation from one that cannot.
Compounded product
Sourcing is the first question, every time
Which pharmacy
Named, with its registration status, and whether it is a 503A or a 503B facility. These are not interchangeable in an underwriter's eyes.
What exactly
The specific formulation, including whether anything is combined with the active ingredient.
Documented where
In the chart, per patient, per fill. A general statement about the practice's supplier is not the same thing.
Told to whom
Whether the patient was informed the product is compounded rather than the branded manufactured product, and where that is recorded.
Screening and monitoring
The protocol questions
What a current submission is asked for
- Screening criteria, including contraindications and what disqualifies a patient.
- Baseline workup and which labs are drawn before the first dose.
- Dose escalation protocol and who authorizes a change.
- Monitoring interval, and what happens when a patient misses one.
- After hours instructions given to the patient, in writing, for an adverse reaction.
- Whether any patient is treated without an in person evaluation, and under what policy.
The climate
Why this is being asked now
Plaintiff activity in this class has grown and the published claim patterns are consistent: inadequate screening, inadequate warning of side effects, and poor documentation of the sourcing of compounded product.
None of that is a statement about any particular practice, and none of it is a statement about what a policy does. It is what the files that end up in litigation have in common, and it is why the questions above are now standard rather than occasional.
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