For your clinic, this impacts: Your service menu Treatment descriptions Consent forms Marketing materials If you say a treatment is "FDA-approved" when it isn't, or hint at benefits the data doesn't back, you risk regulatory trouble
While both categories aim to address sexual dysfunction, their mechanisms of action, effectiveness, and target populations vary significantly
Specifically, one commenter suggested that CMS consider unpackaging their product, a contrast agent, and believed CMS's reasoning in the CY 2026 OPPS/ASC proposed rule for unpackaging and paying separately for diagnostic radiopharmaceuticals applies equally or even more to their product, since the cost of their product is over 500 times greater than the amount reported for the policy packaged drugs offset associated with the Level II Urology APC
Injectable GHK-CU dosing Subcutaneous injection remains the gold standard for systemic GHK-CU effects
In research settings, theyre commonly studied for their potential in areas similar to cellular signaling, molecular interplay, and biochemical exploration