Wiki compounded semaglutide administration guidance

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ksobota

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Looking for some guidance for our physicians. They have been looking into compounded semaglutide for weight loss patients managed in the clinic and I am trying to figure out what they can and can not do regarding billing to insurances.
Patients would pay cash for the semaglutide medication dose itself weekly based on the amount they are on/titrated to from a private stock kept in the office (the clinic would order from the compounding pharmacy).

But in relation to insurance billing:
If they come in and meet with the physician for the injection weekly and are checked for any complications or adverse effects and monitoring their health/progress (i.e. 9921x?)
If they come in and meet with the doctor periodically to monitor adverse effects and the in between visits they would be coming into the office and nurses would dose it out and give the injection from an office stock (99211 vs 96372?)
If they should be only accepting cash for all services related to any visit for the compounded semaglutide visits/surveilance and injections?
Any scenarios honestly.

Online I'm only finding information related to "it's not FDA approved for weight loss" but no real guidance on it related to insurance billing and no nos. Just need to have something credible to show physicians and I am pulling my hair out looking. I know CMS will cover administration of certain compounded drugs but they have to be FDA approved and as of 10/2023 looks like it is not.

Any information/input on what other clinics are doing or I can look into and provide them (and myself!) regarding would help!
 
ksobota said:
Looking for some guidance for our physicians. They have been looking into compounded semaglutide for weight loss patients managed in the clinic and I am trying to figure out what they can and can not do regarding billing to insurances.
Patients would pay cash for the semaglutide medication dose itself weekly based on the amount they are on/titrated to from a private stock kept in the office (the clinic would order from the compounding pharmacy).

But in relation to insurance billing:
If they come in and meet with the physician for the injection weekly and are checked for any complications or adverse effects and monitoring their health/progress (i.e. 9921x?)
If they come in and meet with the doctor periodically to monitor adverse effects and the in between visits they would be coming into the office and nurses would dose it out and give the injection from an office stock (99211 vs 96372?)
If they should be only accepting cash for all services related to any visit for the compounded semaglutide visits/surveilance and injections?
Any scenarios honestly.

Online I'm only finding information related to "it's not FDA approved for weight loss" but no real guidance on it related to insurance billing and no nos. Just need to have something credible to show physicians and I am pulling my hair out looking. I know CMS will cover administration of certain compounded drugs but they have to be FDA approved and as of 10/2023 looks like it is not.

Any information/input on what other clinics are doing or I can look into and provide them (and myself!) regarding would help!
Click to expand...
I have some info regarding billing for an E/M and an injection (sorry, nothing on the specific FDA questions).

Question: When is it appropriate to bill for an E/M visit on the same day as an injection?

Answer: There are two scenarios where this may be supported.
  1. When There is an Unrelated Diagnosis Addressed: Be sure to document clearly why the visit is necessary. If the unrelated problem has recently been addressed or is stable, it may not be considered medically necessary to be assessed again at every (or even every other) recurring visit. Use the diagnosis code for the patient’s new or unrelated complaint.
  2. When a Medically Necessary Re-Evaluation of Patient’s Clinical Status is Required: This could be due to worsening of condition, poor response to treatment plan and a NEED to determine if the treatment plan should be continued or changed. If the case is complex and requires revisions to the treatment plan, be sure to document the necessity and your thought process behind this. In this case, the diagnosis would be the same as the reason for the injection. (This would work when checking for any complications or adverse effects and monitoring their health/progress 99212-99215)
If a patient is complaining about a new problem or side effects of the treatment plan that absolutely need to be assessed, get it in ink! And if the chronic stable problems are assessed at every visit - why? If the note has no indication of a patient complaint of a worsening problem or new problem, it is very difficult to understand the reason to assess those problems at every injection/infusion visit.

If the patient comes in only for the injection given by the nurse, you can either bill for the 99211 plus the medications or bill for the injection (96372) plus the medications. When the nurse must make an evaluation of the patient (e.g., when giving a depo-progesterone shot, the nurse must consider, “might the patient be pregnant?”), then our practice uses the 99211.
 
You need to also consider whether the patient's insurance covers weight loss related services/treatment. They may phrase the exclusion of this treatment as "treatment and or services related to weight management, weight loss management, obesity or morbid obesity..." in which case the E&M and injection code would not be covered regardless of the fact that there is or is not FDA approval. Also, plans may exclude services provided in relation to a non-FDA approved drug. So, even if the plan covers weight loss related services/treatment, since the compounded drug is not FDA approved, they will not pay for any services related to the use of the noncovered drug. So again, the E&M and injection code would not be covered.

You need to make certain that for each patient who has insurance you want to bill the E&M or injection admin codes to do not exclude these services for either of the reasons I listed. The insurance company I work for would not cover the E&M or injection admin code if the plan the patient has excludes weight loss related services/treatment or if the plan excludes coverage of services used in conjunction with a non-FDA approved drug or device.
 
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