In July 2012 the Massachusetts legislature enacted several
statutory
amendments to the so-called physician gift ban law,
Mass. Gen. L. c. 111N ("Chapter 111N"). Chapter 111N
restricts transfers of value between pharmaceutical and medical
device manufacturers and Massachusetts-licensed prescribers.
Prior to these statutory amendments, the law banned any
manufacturer-sponsored meals for health care practitioners that
were provided outside of the hospital setting. One of the recent
statutory amendments now permits manufacturers to pay for
"modest meals and refreshments in connection with
non-CME educational presentations for the purpose of educating and
informing healthcare practitioners about the benefits, risks and
appropriate uses of prescription drugs or medical devices, disease
states or other scientific information, provided that such
presentations occur in a venue and matter conducive to information
communication" (emphasis supplied). In order to provide
clarity on this new statutory provision, the amendments expressly
required the Department of Public Health (DPH) to define
"modest meals and refreshments" by regulation.
At a hearing of the Public Health Council on September 19, 2012,
DPH presented
emergency amendments to the Pharmaceutical and Medical Device
Manufacturer Conduct regulations (105 CMR 970) in order to
implement the recent amendments to Chapter 111N. Among other
proposed changes, these emergency regulatory amendments define
"modest" meals and refreshments as "food and or
drinks provided by or paid for by a pharmaceutical or medical
device manufacturing company or agent to a health care practitioner
that, as judged by local standards, are similar to what a
health care practitioner might purchase when dining at his or her
own expense" (emphasis supplied). At the hearing, the DPH
stated that this definition was based in part on
guidance for health care practitioners published by the
American Medical Association.
The emergency regulatory amendments propose two other changes of
note. First, they would relieve companies from any disclosure of
expense reports (and the payment of accompanying reporting fees to
the DPH) for all calendar years after 2012, with one exception:
companies reporting marketing expenses under the federal Sunshine
Act (42 U.S.C. § 1320a-7h) to the U.S. Department of Health
and Human Services (HHS) need only provide quarterly reports to DPH
of the estimated amount expended on meals per participant at
education programs held outside of the hospital setting. This
regulatory amendment is likely intended to align the existing
reporting requirements with the federal Sunshine Act, which
pre-empts any state law requiring manufacturers to report to a
state any marketing expense information that also must be reported
to HHS.
Second, the emergency regulatory amendments confirm, as required
by the recent statutory amendments to Chapter 111N, that medical
device companies can reimburse health care practitioners for
reasonable expenses necessary for technical training on the use of
a medical device, regardless of whether such payments are permitted
under a purchase contract for the device.
While the Public Health Council approved the emergency regulatory
amendments to be effective immediately, the next step is for DPH to
hold a
public hearing on the emergency regulatory amendments. This
public hearing is scheduled for October 19, 2012 at 10:00 AM.
Written comments on the proposed emergency regulatory amendments
must be submitted by October 26, 2012.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
