On November 21, 2012, the Public Health Council promulgated
final revised regulations relating to the so-called
physician gift ban law, Mass. Gen. Laws c. 111N ("Chapter
111N"). Most notably, the revised regulations now permit
"modest" meals to be provided at manufacturer-sponsored
educational presentations held outside of the hospital setting,
streamline marketing expense reporting requirements for
manufacturers, and authorize manufacturers to reimburse health care
practitioners for medical device training expenses.
In July 2012, the Massachusetts legislature enacted several
statutory
amendments to Chapter 111N. Prior to these statutory
amendments, Chapter 111N banned any manufacturer-sponsored meals
for health care practitioners that were provided outside of the
hospital setting, and required manufacturers to report to the
Massachusetts Department of Public Health (DPH) a broad range of
marketing expenses and other transfers made to drug prescribers and
purchasers.
One of the new statutory amendments permits manufacturers to
provide "modest meals and refreshments" to health care
practitioners outside of the hospital setting 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).
The statutory amendments expressly require 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). The
Public Health Council heard public testimony on the emergency
amendments at a public hearing on October 19, 2012. On
November 21, 2012, the Public Health Council voted to
promulgate final regulations (effective upon publication
in the Massachusetts Register on December 7, 2012).
The final regulations make the following three significant changes
to 105 CMR 970. First, with respect to meals, manufacturers may now
provide "modest" meals and refreshments at
manufacturer-sponsored educational presentations outside of the
hospital setting. "Modest" meals and refreshments are
defined 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). DPH has
stated that this definition is based in part on guidance for health care practitioners
published by the American Medical Association.
Manufacturers sponsoring meals at educational programs must
disclose on a quarterly basis (a) the location of the presentation,
(b) a description of the products discussed, (c) the total amount
expended on such presentation, (d) an estimate of the
per-participant expenditure for meals, refreshments and other items
of economic value, and (e) any other information determined
necessary by DPH. The Public Health Council has suggested that in
the category of "any other information," DPH may consider
such other expense categories as alcohol costs and speaker
qualifications.
Second, with respect to the reporting of marketing expenses, under
the revised regulations, manufacturers reporting marketing expenses
under the federal Sunshine Act (42 U.S.C. § 1320a-7h) to the
U.S. Department of Health and Human Services are relieved from
reporting the same information to DPH. However, manufacturers must
continue to comply with all other expense reporting requirements
under 105 CMR 970.009. This regulatory amendment is likely intended
to align the existing Massachusetts 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.
Finally, the final regulations 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.
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