Reclast, Prolia - Change in Part B Coverage?

[VolAgent]

I wasn't questioning that you left it off. I was merely pointing out that it makes a difference.

The prescribing guidelines aren't "suggestions" from the manufacturer. The guidelines are part of the FDA approval process. Technically, if your doctor isn't following the guidelines, they are guilty of malpractice.

My point is that the 4th bullet point makes the difference.

"Prolia should be administered by a healthcare professional"

Osteoporosis at High Risk for Fracture Treatment | Prolia® (denosumab)

Medicare rules (and carriers) cannot override the FDA. And if it requires a professional, that makes it Part B.

If Medicare wants move it to Part D, they better call the FDA and get the guidelines updated.

Its not just malpractice, it is actually illegal. Best friend is a drug rep.

It is actually illegal not to follow the manufacturer's prescribing rules. Now that is rules, not guidelines, but still. Also, I have no idea what the penalty is.