N.J. AG proposes gift ban rules

New Jersey attorney general Anne Milgram wants the Garden State to adopt rules akin to regulations in Massachusetts and Vermont, so-called “gift bans” governing the relationship between industry and physicians.

Like its more northern neighbors in the Bay and Green Mountain states, the proposed rules aim to address “the pervasive and largely unregulated conflicts of interest that arise from the financial relationships between physicians and pharmaceutical and medical device companies.”

“Such financial relationships threaten to bias medical decision-making and compromise patient health. The residents of the State of New Jersey deserve a medical community that is free from such conflicts,” according to a report (PDF) by Milgram’s office, which would ban New Jersey docs from acepting free meals from medical device and drug companies.

“For years, pharmaceutical companies and medical device manufacturers have given physicians expensive gifts, free vacations, and lavish meals. In addition, recent studies demonstrate that even gifts of nominal value, including food, have an impact on physician prescribing practices. The receipt of gifts, payments and perks — large and small — engenders a loyalty (or feeling of obligation) in the receiver to reciprocate,” according to the report.

It also recommends that MDs looking to renew their license be forced to disclose anything received from device or drug makers in excess of $200 during the previous two years, and that the state dump that information into a public database.

That’s a departure from the rules in Massachusetts and Vermont, which put the reporting onus on industry instead of physicians. The proposal is akin to Vermont’s rules in one respect, with its ban on the sale of prescription data that can be linked to doctors. Companies including IMS Health use that data as the basis of a healthy business, delivering reports to pharma companies detailing the prescribing habits of individual docs.

But the proposal does include a caveat that would mitigate some of the sting for medical device makers and pharma, namely, free samples.

“The regulations, however, should permit the receipt of items that provide a direct benefit to patients, such as, samples or anatomical models for use in examination rooms,” the report states, adding that the regs should also allow docs to be paid for speeches and the like that “indirectly benefit patients by advancing physician learning or legitimate research goals.”

Here’s a list of the report’s 22 recommendations:

  1. Amend [Board of Medical Examiners] regulations to expressly forbid a licensee from accepting from any pharmaceutical or medical device manufacturer any of the following, either directly or indirectly:
    • Any payment or other subsidy (including tuition, fees, travel, lodging or other incidental expenses) to support attendance as a participant at an accredited continuing medical education program.
    • Any fees or travel or lodging reimbursement for non-faculty or non-consultant attendees at company-sponsored meetings.
    • Items intended for the personal benefit of a licensee (including, but not limited to, floral arrangements, artwork, CDs, DVDs or tickets to a sporting event) or items that may have utility in both the professional and non-professional setting (including, but not limited to, a DVD or a CD player).
    • Any payment in cash or a cash equivalent (such as a gift certificate) unless it is compensation for bona fide services (such as serving as a consultant or participating in research or publication activities).
    • Any company-funded entertainment or recreational item, unless the health care professional is a salaried employee of the manufacturer.

    The regulations, however, should permit the receipt of items that provide a direct benefit to patients, such as, samples or anatomical models for use in examination rooms. In addition, the regulations should permit physicians to accept things of value, such as, remuneration for service as a speaker or faculty organizer for CME events, which indirectly benefit patients by advancing physician learning or legitimate research goals.

  2. Amend BME regulations to prohibit physicians and physician in-office staff from accepting food from manufacturers, whether in-office, at health care facilities or in commercial venues, such as restaurants.
  3. Amend BME regulations to require physicians attending unaccredited educational or promotional sessions organized by manufacturers at which meals are served, to pay the fair market value for the meals served in connection with those sessions.
  4. Amend BME regulations to allow the receipt of modest meals at CME seminars, third-party conferences and professional meetings accredited by the Accreditation Council for Continuing Medical Education or the American Asteopathic Association, where the provision of meals facilitates the scheduling of the educational program to maximize physician learning, and where such meals are provided at the discretion of the CME provider. Such meals may not be paid for directly by manufacturers.
  5. Amend BME regulations to permit continued receipt of sample medications by physicians for the exclusive benefit of patients without charge. The value of samples would not count towards the disclosure threshold.
  6. Mandate, as part of the BME biennial renewal process (until the creation of an on-line system allowing regular updates), that physicians disclose whether they accepted more than $200 during the preceding two years from manufacturers in the form of compensation, food, travel, consulting fees or honoraria, funding for research, funding for education, stock or stock options, ownership or investment interest, or any other economic benefit. The required disclosure should include the name of the company, the value, date and nature of the payment, and if applicable, the name of the product, and whether the payment is related to marketing, education or research pertaining to a specific drug, device, biological or medical supply.
  7. Create a searchable, user-friendly database to make physician-disclosed information available to the public and require physicians to post a notice in their offices advising consumers of the existence of the database. If technologically feasible, doctors should be responsible for updating disclosures into the database periodically. And as an alternative means of reporting, companies should be given access to provide direct disclosure of information to the database.
  8. The State of New Jersey should enact legislation requiring manufacturers to disclose payments and other things of value made to physicians, physician practices and physician groups – identifying the name, nature and purpose for the payment, unless the payment has been reported to a recognized national database.
  9. Amend BME regulations to provide credit only for those CME courses that meet ACCME or AOA standards that specifically bar the CME provider from obtaining advice from a subsidizing company as to faculty or content. Promotional dinners and workshops would not be counted towards CME mandates.
  10. Amend BME regulations to impose an obligation on physicians who are engaged as CME speakers to directly disclose to physician-learners, at the beginning of the presentation, the receipt of reportable compensation from manufacturers.
  11. Amend BME regulations to direct that 25% of the required CME be obtained in evidence-based educational programs or through academic detailing. This requirement would be phased-in over future biennial renewal periods.
  12. Utilize the BME biennial renewal process and the BME website to acquaint physicians with the AMA’s opt-out of data-mining program.
  13. Amend Board of Pharmacy regulations to require pharmacies to maintain documentation confirming that prescribers have consented to the sale of their prescribing information.
  14. The State of New Jersey should enact legislation to restrict the transfer, use or sale of prescriber-identifiable prescription information for commercial purposes.
  15. Amend BME regulations to hold physicians, who are serving as faculty and preceptors, accountable to adhere to AAMC guidelines, both on and off campus.
  16. Amend BME regulations to add a requirement that Medical Education Directors incorporate, as part of residency training, curriculum designed to teach residents to identify: (a) evidence-based data; and (b) conflicts of interest. Such instruction will permit residents to better assess the impact that the source of research funding may have on the value of the information presented.
  17. Amend BME regulations to prohibit physicians from recklessly providing inaccurate and misleading information in educational or promotional venues.
  18. Amend BME regulations to prohibit physicians from claiming authorship of any article or study unless they, in fact, authored the work in question. Attribution should, however, be deemed appropriate if the physician supervised or reviewed the work of medical students, residents, fellows or researchers.
  19. Amend BME regulations to prohibit physicians from misrepresenting financial interests in any required disclosure form, including through the omission of required information.
  20. DHSS is encouraged to promulgate policies and procedures that address the following:
    • Creation of a standardized conflict of interest form for use by all New Jersey licensed health care facilities.
    • 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.
    • Whether disclosures of interests should be mandated in in-hospital educational venues before presentations begin (i.e. grand rounds, patient rounds and classroom).
    • Creation of programs that allow community hospitals to ensure that the acceptance of industry funding for CME does not skew the message of educational sessions.
    • Creation of a system to manage conflicts to avoid potential detriment to the safety of clinical trial participants or to the integrity of the research.
  21. Encourage the creation of academic detailing programs by amending BME regulations to require that a certain percentage of the required CME credits be derived from the completion of courses not subsidized by industry.
  22. Explore grants that could introduce academic detailing programs in some DHSS regulated venues.

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