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| Colleagues,
Starting this week there are new state rules regarding physician interactions with the pharmaceutical industry (these rules do not apply to the medical device industry). These rules are not dramatically different than the Cooper policy governing such interactions. The current Cooper policy is attached. Below is our legal department’s highlights of the rule followed by a few links that should also help with clarification. The Cooper policy will be changed where needed to reflect the new rules and these changes will be communicated.
If you have any questions, feel free to contact Cooper’s General Counsel Gary Lesneski (lesenski-gary@cooperhealth.edu) or Cooper’s Chief Compliance Officer Angela Melillo (melillo-angela@CooperHealth.edu).
From Cooper Legal:
The new rules governing prescriber acceptance of compensation from pharmaceutical manufacturers, which was the subject of a prior report to you, are now in place. Every new relationship from tomorrow on must take these into account. There are some substantive differences between the prior proposal, which clarify important exceptions.
As you know, we already have an extensive policy for our physicians governing these relationships (Policy 12.101 – Physician Conflicts of Interest). Some of our already policy determinations are already as restrictive as the new rules.
Accordingly, what I will do here is highlight the additional restrictions that now must be taken into account:
• The new rules apply to physicians, podiatrists, physician assistants, advanced practice nurses, dentists, and optometrists. Our current policy applies to “all members of the medical staff, as well as residents, fellows, and students who are receiving training at CUHC (“CUHC Physicians”).” So, as you can see, the focus of the rule is on practitioners with prescribing privileges. As a practical matter, we are going to apply any more restrictive provisions to the universe of persons covered by our current policy. The differences in scope are obviously slight;
• The $10,000 “cap” – the new rule says the prescriber shall not accept more than $10,000 in the aggregate from all pharmaceutical manufacturers in any calendar year “for the bona fide services of presentations as speakers at promotional activities, participation on advisory boards. We do need to focus on what is included in the definition of a pharmaceutical manufacturer. A “pharmaceutical manufacturer is EITHER (1) engaged in the production, preparation, propagation, compounding, conversion, or processing of prescription drugs or biologics, by extraction from substances of natural origin, or independently by means of chemical synthesis OR (2) is directly engaged in the packaging, repackaging, labeling, relabeling, or distribution of prescription drugs or biologics. This definition reflects the purpose behind the new rules, which emanates from the opioid addiction initiative. So, as you can see, it really doesn’t cover device manufactures, unless the device manufacturer’s product fits into the chain of activities described above. Licensed pharmacies and licensed health care facilities are NOT considered “pharmaceutical manufacturers.”
• The cap doesn’t apply to speaking at “educational events.” The term “education event” is specifically defined as well to include an “education event, third party scientific or educational conference, professional meeting or workshop, seminar, U.S. Food and Drug Administration required education and training, and any other gathering…” subject to the following qualifications: first, the activity must be held in a venue that is appropriate and conducive to informational communication and training about healthcare information; second, the gathering must be primarily dedicated, in both time and effort, to promoting objective scientific and educational activities and discourse ( one or more educational presentations should be the highlight of the gathering), and; third, the main purpose for bringing attendees together is to further their knowledge of the topics being presented.
• The cap also doesn’t apply to payments for research activities or for royalties and licensing fees.
• Any of these arrangements, consistent with our existing rules, must be in writing and payments must be at fair value. The general requirements of the writing are largely consistent with our current expectations. There appears to be an expectation that all agreements will be more specific as to how the prescriber’s participation is reasonably related to achieving the purpose of the arrangement.
• These new rules delve deeper into familiar relationships than our current policy. Our policy is pretty broad but I would simply work off the new rule which defines “immediate family” to include:
• Spouse, civil union or domestic partner or child
• The following if they live in the same household: the prescriber’s, spouse’s, civil union or domestic partner’s parent, brother, sister, aunt, uncle, niece, nephew, grand[aren’t, grandchild, son-in-law, daughter-in-law, stepparent, stepchild, stepbrother, stepsister, half-brother, or half-sister, whether the relative is related to the individual or the individual’s spouse, civil union partner, or domestic partner by blood, marriage or adoption
• The rule have a long list of precluded gifts – again, we are already strict in that regard. The new rules will still permit acceptance of: items designed primarily designed for educational purposes for patients or the prescriber and have minimal or no value to the recipient outside of professional responsibilities; registration fees for an educational event if all attendees get the same break; “modest” meals (Value= $15 or less)at educational events or through promotional activities if the practitioner is non-faculty (I see his as more liberal than our own policy – we will stick with our rule); speaker fees for bona fide services at educational events and promotional activities and associated reasonable travel, lodging and personal expenses ( again, in the promotional activities context my first reaction is that this is more liberal than our current policy and will keep us where we are)
• The rules also address samples – basically, they can be accepted if exclusively intended for the benefit of prescriber’s patients, cannot be charged for and must comply with all licensing board dispensing rules
Link to outside reporting on the topic: Unofficial Clean Version of Rule
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