A New Jersey Division of Consumer Affairs report just released by New Jersey Attorney General Anne Milgram has recommended new regulations meant to limit the potential for conflicts of interest between doctors and pharmaceutical companies and medical device manufacturers.  This article summarizes some of the key points of the proposed regulations.

The report's proposed regulations would complement existing industry codes (e.g., PhRMA Code, AdvaMed Code, MDMA Guidelines) and establish the strictest code of ethics requirements in the country, going well beyond any industry code or state or federal law.  The regulations would ban doctors from accepting gifts, fees or travel expense reimbursements from any pharmaceutical or medical device manufacturers, going as far to even bar physicians from accepting free food and meals in office settings, healthcare facilities or at promotional dinners.  Although modest meals could still be provided at CME events, physicians attending unaccredited educational or promotional sessions organized by manufacturers at which meals are served would be required to pay the fair market value for the meals served in connection with those sessions.

Manufacturers would still be allowed to provide product samples that are given for the exclusive benefit of the patient.

The proposed regulations would be the first code of ethics/aggregate spend disclosure requirement to mandate that doctors disclose payments under the law.  Specifically, the regulations would require doctors serving as consultants to pharmaceutical companies or medical device manufacturers disclose publicly every two years any acceptance of more than $200 in consulting fees, honoria or funding for research or education.

The Code of Ethics regulations would also include a data mining provision which would require that all physicians be notified when renewing their licenses that they can opt out of having their prescription information sold to health care information organizations by pharmacists.

Furthermore, the report includes a number of conflict of interest recommendations for the NJ Department of Health and Senior Services, including the following:

create a standardized conflict of interest form for use by all New Jersey licensed health care facilities;

consider whether physicians with financial interests should serve on advisory bodies, such as formulary committees, purchasing committees or groups established to develop practice guidelines, or should conduct clinical trials or participate in IRB research;

consider whether disclosures of interests should be mandated in in-hospital educational venues before presentations begin;

create programs allowing community hospitals to ensure that the acceptance of industry funding for CME does not skew the message of educational sessions; and

create a system to manage conflicts to avoid potential detriment to the safety of clinical trial participants or to the integrity of the research.

The responsible NJ departments, including the Board of Medical Examiners and the Board of Pharmacy, have been asked to review the report and initiate a rule-making process. The New Jersey Register would then publish any regulations the boards propose to allow a full opportunity for comment. Finalized regulations would await consideration of those comments, which is expected to take at least six months.

Stay tuned as R-Squared will be tracking the latest developments of the regulations proposed in this report.  If nothing else, it is just another example that states will not slow down their own regulation of pharmaceutical and medical device manufacturers despite the pending federal Sunshine provisions.  In addition, although a new administration will be taking over in New Jersey in January, it is unlikely that this aggressive regulation will be curtailed since Governor-Elect Chris Christie is well-known for his landmark "Hip and Knee" settlements against medical device companies.

The full report on physician compensation arrangements by the NJ Division of Consumer Affairs can be found here, or an executive summary of the report can be found here.