Drugmakers that pay physicians for authoring ghostwritten papers, switching prescriptions or being "shadowed" by drug reps are likely to be violating federal anti-kickback laws, according to a new compliance guidance issued by the HHS Office of the Inspector General.
The 39-page guidance, issued Monday, also warns drugmakers against using certain other forms of marketing tactics, submitting inaccurate or inadequate payment data, inappropriately using drug samples and failing to train drug reps on anti-kickback rules.
Published in draft form in October, the document is meant to give companies a benchmark against which to evaluate their efforts and is not legally binding.
Specifically, the guidance advises drugmakers against the following activities:
- Switching arrangements, in which physicians are paid each time a patient's prescription is changed.
- Paying physicians for "shadowing," in which drug company reps follow physicians on their rounds.
- Paying physicians for giving their names to ghostwritten papers or speeches.
- Payment of doctors for listening to sales representatives market pharmaceutical products.
- Compensating physicians as "consultants" for attending meetings or conferences primarily in a passive capacity is suspect.
- Using physicians for speaking or certain research when it is "connected directly or indirectly to a manufacturer's marketing and sales activities."
- Presentations to physicians "if any one purpose of the arrangement is to generate business for the pharmaceutical company."
- Research contracts that originate through the sales or marketing functions or that are offered to physicians in connection with sales contacts.