Trenton,
NJ - Attorney General Anne Milgram today released
a report from the Division of Consumer Affairs
recommending new regulations to curtail the
potential for conflicts of interest between
doctors and pharmaceutical companies and medical
device manufacturers.
The
recommendations address the impact of potential
conflicts on patient care, and set forth new
policies to be considered by the Board of
Medical Examiners, the Board of Pharmacy,
the Department of Health and Senior Services
and academic medical centers.
Serving
as a complement to voluntary industry codes,
proposed regulations would ban doctors from
accepting any gifts or fees or travel expense
reimbursement from any pharmaceutical or medical
device manufacturers. In addition, the proposed
reforms bar physicians from accepting free
food and meals in office settings or at promotional
dinners.
Recommended
regulations would also require doctors who
do serve as consultants to pharmaceutical
companies or medical device manufacturers
to publicly disclose every two years the acceptance
of more than $200 in consulting fees, or honoria,
or funding for research or education.
“The
proposed regulations accompanying the report
on physician compensation are designed to
ensure that patient care is guided by the
unbiased exercise of doctors’ best judgments,”
Attorney General Milgram said, in endorsing
the report’s recommendations. “It
is critical to minimize the potential for
conflicts and it is critical that patients
are made aware of any financial relationship
between a physician and a pharmaceutical company
or medical device manufacturer. Such relationships
could bias medical decision-making.”
The report recommends tight controls on what
is known in the pharmaceutical industry as
“data mining,” or tracking physician
prescription information. All physicians would
have to be notified when renewing their licenses
that they can opt out of having information
about their prescriptions sold by pharmacists
to healthcare information organizations, which
collect information on prescriptions for pharmaceutical
company marketing. In addition, the report
recommends that the Board of Pharmacy amend
its regulations to require pharmacies to maintain
documentation that doctors have consented
to the sale of their prescribing information.
The report also recommends legislation to
restrict the use and sale of prescriber information
for commercial purposes.
The
report – policy recommendations from
the Division of Consumer Affairs -- was presented
to the Attorney General by David Szuchman,
the director of the Division of Consumer Affairs.
Szuchman and Division’s staff met with
physicians, pharmacists, hospital executives,
and pharmaceutical industry and insurance
company representatives in compiling the report.
Several
states, including Vermont, Maine, Massachusetts,
Minnesota and West Virginia have imposed disclosure
obligations on the pharmaceutical industry.
The New Jersey report recommends adopting
specific requirements directed at the state’s
33,000 doctors who are licensed by the state
Board of Medical Examiners.
The
Pharmaceutical Research and Manufacturers
of America (PhRMA) and the Advanced Medical
Technology Association (AdvaMed) have adopted
voluntary codes of ethics that prohibit member
companies from providing entertainment, vacations
or meals to physicians, unless the meals are
modest and at a medical office or in a clinical
setting. The proposed New Jersey regulations
would go beyond the industry codes, banning
all food except at accredited continuing medical
education events where physicians must pay
the fair market value of modest meals provided.
Proposed Board of Medical Examiners’
regulations would expressly forbid a licensee
from accepting any payment or subsidy to support
attendance at an accredited continuing medical
education program. These regulations would
prohibit fees or travel expense reimbursement
for attending company-sponsored meetings unless
a doctor appears as a paid consultant or as
a teacher at the meeting.
Any
items for personal use, like CDs, DVDs, entertainment
and sporting events tickets, would be forbidden.
The
regulations would allow doctors to accept
items that could directly benefit patients,
such as prescription samples or anatomical
models used in doctors’ offices.
With
regard to meals, the report recommends that
the Board of Medical Examiners adopt regulations
to prohibit physicians and their in-office staff
from accepting free meals from manufacturers
both in-office and at restaurants. Doctors attending
unaccredited promotional educational sessions
sponsored by pharmaceutical companies and medical
device manufacturers should pay for their own
meals. Physicians
can serve as consultants and participate in
the research and development of new treatments
and therapies, and enter into financial contracts
with drug and medical device manufacturers.
But those financial relationships should be
fully disclosed by the physicians every two
years when licenses are renewed. The report
also recommends that the Board of Medical
Examiners create a searchable database to
make physician-disclosed information available
to the public. The report further recommends
that the Legislature pass legislation requiring
manufacturers to disclose payments to physicians.
In
the area of continuing medical examination,
the report recommends that CME credit is only
received by doctors for courses that are accredited
by the Accreditation Council for Continuing
Medical Education (ACCME) and specifically
bar the CME provider from obtaining advice
from a company that subsidizes the course,
creating a separation between educational
content and the source of the subsidy.
The
report also makes recommendations concerning
physicians-in-training, physician accountability,
academic detailing and potential conflicts
in health care facilitiesg.
The
Board of Medical Examiners and the Board of
Pharmacy are being asked to review the report
and initiate a rule-making process. Any regulations
the Boards decide to propose would then be
published in the New Jersey Register, allowing
a full opportunity for anyone interested to
comment. Any finalized regulation would await
consideration of those comments, a process
that would be likely to take at least six
months.
###
|