{"id":946,"date":"2018-01-18T16:02:53","date_gmt":"2018-01-18T16:02:53","guid":{"rendered":"http:\/\/blogs.cooperhealth.org\/ctd\/?p=946"},"modified":"2018-01-18T16:02:53","modified_gmt":"2018-01-18T16:02:53","slug":"new-state-regulations-regarding-physician-interactions-with-the-pharmaceutical-industry","status":"publish","type":"post","link":"https:\/\/blogs.cooperhealth.org\/ctd\/2018\/01\/new-state-regulations-regarding-physician-interactions-with-the-pharmaceutical-industry\/","title":{"rendered":"New State Regulations regarding physician interactions with the pharmaceutical industry"},"content":{"rendered":"\n\n\n
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New State Regulations<\/strong><\/td>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/td>\n<\/tr>\n
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Colleagues,<\/p>\n

 <\/p>\n

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).\u00a0\u00a0 These rules are not dramatically different than the Cooper policy governing such interactions.\u00a0\u00a0 The current Cooper policy is attached.\u00a0\u00a0 Below is our legal department\u2019s highlights of the rule followed by a few links that should also help with clarification.\u00a0\u00a0The Cooper policy will be changed where needed to reflect the new rules and these changes will be communicated.<\/p>\n

 <\/p>\n

If you have any questions, feel free to contact Cooper\u2019s General Counsel Gary Lesneski (lesenski-gary@cooperhealth.edu<\/a>) or Cooper\u2019s Chief Compliance Officer Angela Melillo (melillo-angela@CooperHealth.edu<\/a>).<\/p>\n

 <\/p>\n

 <\/p>\n

From Cooper Legal<\/strong>:<\/p>\n

 <\/p>\n

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\u00a0 between the prior proposal, which clarify important exceptions.<\/p>\n

 <\/p>\n

As you know, we already have an extensive policy for our physicians governing these relationships (Policy 12.101 \u2013 Physician Conflicts of Interest). Some of our already policy determinations\u00a0are already as restrictive as the new rules.<\/p>\n

 <\/p>\n

Accordingly, what I will do here is highlight the additional restrictions that now must be taken into account:<\/p>\n

 <\/p>\n

\u2022\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 The new rules apply to physicians, podiatrists, physician assistants, advanced practice nurses, dentists, and optometrists. Our current policy applies to \u201call members of the medical staff, as well as residents, fellows, and students who are receiving training at CUHC (\u201cCUHC Physicians\u201d).\u201d So, as you can see, the focus of\u00a0 the rule is on practitioners with prescribing privileges.\u00a0 As a practical\u00a0 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;<\/p>\n

 <\/p>\n

\u2022\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 The $10,000 \u201ccap\u201d \u2013 the new rule says the prescriber shall not accept more than $10,000 in the aggregate from all pharmaceutical manufacturers in any calendar year \u201cfor 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.\u00a0 A \u201cpharmaceutical 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.\u00a0 This definition reflects the purpose behind the new rules, which emanates from the opioid addiction initiative.\u00a0 So, as you can see, it really doesn\u2019t cover device manufactures, unless the device manufacturer\u2019s product fits into the chain of activities described above.\u00a0 Licensed pharmacies and licensed health\u00a0 care facilities are NOT considered \u201cpharmaceutical manufacturers.\u201d<\/p>\n

 <\/p>\n

\u2022\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 The cap doesn\u2019t apply to speaking at \u201ceducational events.\u201d The term \u201ceducation event\u201d is specifically defined as well\u00a0 to include an \u201ceducation 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\u2026\u201d 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\u00a0 for bringing attendees together is to further their knowledge of the topics being presented.<\/p>\n

 <\/p>\n

\u2022\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 The cap also doesn\u2019t apply to payments for research activities or for royalties and licensing fees.<\/p>\n

 <\/p>\n

\u2022\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 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\u2019s participation is reasonably related to achieving the purpose of the arrangement.<\/p>\n

 <\/p>\n

\u2022\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 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 \u201cimmediate family\u201d to include:<\/p>\n

 <\/p>\n

\u2022\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 Spouse, civil union or domestic partner or child<\/p>\n

 <\/p>\n

\u2022\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 The following if they live in the same household: the prescriber\u2019s, spouse\u2019s, civil union or domestic partner\u2019s parent, brother, sister, aunt, uncle, niece, nephew, grand[aren\u2019t, 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\u2019s spouse, civil union partner, or domestic partner by blood, marriage or adoption<\/p>\n

 <\/p>\n

\u2022\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 The rule have a long list of precluded gifts \u2013 again, we are already strict in that regard.\u00a0 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; \u201cmodest\u201d 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 \u2013 we will stick with our rule); speaker fees\u00a0 for bona fide services\u00a0 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)<\/p>\n

 <\/p>\n

\u2022\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 The rules also address samples \u2013 basically, they can\u00a0 be accepted if exclusively intended for the benefit of prescriber\u2019s patients, cannot be charged for and must comply with all licensing board dispensing rules<\/p>\n

 <\/p>\n

 <\/p>\n

Link to outside reporting on the topic:<\/p>\n

PolicyMed.com Report<\/a><\/p>\n

Unofficial Clean Version of Rule<\/a><\/p>\n

 <\/p>\n

 <\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

New State Regulations Colleagues,   Starting this week there are new state rules regarding physician interactions with the pharmaceutical industry (these rules do not apply…<\/p>\n","protected":false},"author":8,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[5],"tags":[],"class_list":["post-946","post","type-post","status-publish","format-standard","hentry","category-did-you-know"],"post_mailing_queue_ids":[],"_links":{"self":[{"href":"https:\/\/blogs.cooperhealth.org\/ctd\/wp-json\/wp\/v2\/posts\/946","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/blogs.cooperhealth.org\/ctd\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/blogs.cooperhealth.org\/ctd\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/blogs.cooperhealth.org\/ctd\/wp-json\/wp\/v2\/users\/8"}],"replies":[{"embeddable":true,"href":"https:\/\/blogs.cooperhealth.org\/ctd\/wp-json\/wp\/v2\/comments?post=946"}],"version-history":[{"count":1,"href":"https:\/\/blogs.cooperhealth.org\/ctd\/wp-json\/wp\/v2\/posts\/946\/revisions"}],"predecessor-version":[{"id":947,"href":"https:\/\/blogs.cooperhealth.org\/ctd\/wp-json\/wp\/v2\/posts\/946\/revisions\/947"}],"wp:attachment":[{"href":"https:\/\/blogs.cooperhealth.org\/ctd\/wp-json\/wp\/v2\/media?parent=946"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.cooperhealth.org\/ctd\/wp-json\/wp\/v2\/categories?post=946"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.cooperhealth.org\/ctd\/wp-json\/wp\/v2\/tags?post=946"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}