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MOY ET AL
tended. However, there are both direct and indirect negative
consequences to physicians and teaching hospitals as a result
of the Sunshine Act. Although the direct fınancial costs to
physicians and teaching hospitals were estimated to be relatively
modest ($250 and $3,500 for the fırst year, respectively),
the potential for indirect costs from stigmatization of
physicians and/or teaching hospitals cannot yet be assessed.
There is no question that some medical decisions are motivated
by physicians’ associations with manufacturers of
pharmaceuticals and devices, but there are also many legitimate
and benefıcial relationships between physicians and
industry, particularly in the context of research and development
of investigational products. In fact, if Americans wish
to have access to such investigational products, fınancial relationships
between American physicians and industry are
necessary. Notably, the implementation of the Sunshine Act
does attempt to differentiate fınancial relationships associated
with research from those associated with inducement of
prescribing (e.g., speakers bureaus). However, the problematic
implementation of the Open Payments database has led
to signifıcant concerns about the validity of the data. Furthermore,
physicians must access the database to assess the validity
of submitted data (and have the option to dispute specifıc
entries)—potentially a substantial implementation cost. (As
an example, one of the authors of this manuscript spent multiple
hours working directly with the Open Payments database
developers to gain access to his own data, as the record
associated with his National Provider Identifıer number had
been inadvertently duplicated, thereby blocking access.)
The Open Payments website provides a guide for patients
that distinguishes the different types of potential fınancial relationships
of their physicians. 15 These include consulting
fees, “compensation for services other than consulting, including
serving as faculty or as a speaker at an event other
than a continuing education program,” honoraria, gifts, entertainment,
food and beverage (exceeding $10 per year),
travel and lodging, education (including reprints of journal
articles and even if not requested by the physician), research,
charitable contributions, “royalty or license,” “current or
prospective ownership or investment interest,” “compensation
for serving as faculty or as a speaker for an unaccredited
and noncertifıed continuing education program,” “compensation
for serving as faculty or as a speaker for an accredited
or certifıed continuing education program” (but only if the
company recommends the speaker), grant (payments in support
of a specifıc cause or activity), and “space rental or facility
fees.”
Of signifıcant concern is the requirement for companies to
report all indirect payments, specifıcally fınancial support to
third parties (e.g., Conquer Cancer Foundation) who then
utilize a peer review process to allocate funds to grantees. In
this context, the Conquer Cancer Foundation website contains
the following language as a warning to applicants: “This
grant receives support that may result in a report to the Centers
for Medicare & Medicaid Services (CMS) Open Payments
website under the Physician Payments Sunshine Act.
The supporting companies are required to report the amount
of the grant, the names of physicians who are awarded this
grant, and the names of their institutions. This information
may appear on the Open Payments website.” Presumably,
this would dissuade at least some qualifıed applicants from
applying for grants, given concerns about the potential stigmatization
associated with a successful application.
Another area of concern to researchers is companies’ variable
interpretation of the CMS Final Rule in regard to requirements
to report potential “transfers of value” (TOVs) in
the context of research publications (e.g., abstracts, presentations,
original research articles). As clinical research is uncommonly
conducted at single institutions, investigators
must rely on companies for the organization and primary
analysis of results. In addition, many companies utilize professional
medical writers and graphic artists (either employees
or contractors) to assist in the preparation of abstracts,
presentations, and original research articles. Thus, many
companies have interpreted the requirement to report publication
support as a transfer of value to individual physicians,
even though such publications may primarily benefıt
the company. 16,17
Given the interests of Congress to both improve health and
reduce health care costs, it is important to ask whether or not
the Sunshine Act’s implementation challenges outweigh the
potential gains. In fact, patients may be less troubled by the
fınancial relationships of their physicians than Congress. In
one study of 102 patients with advanced cancer, the majority
of patients were not concerned about fınancial relationships
between their physicians and industry but were concerned
about potential intrinsic nonfınancial interests. 18 Specifıcally,
patients were concerned about their physician being
promoted or becoming famous because of their participation
in such research studies. So, if potential physician fame
(rather than fortune) is of highest concern to patients, then
the achievement of fınancial transparency may have little effect
on direct interactions between patients and physicians in
the context of prescribing decisions.
In contrast, Congress has never expressed concern about
physician activities aimed at fame, although often fame begets
fortune, particularly if the famous physician leaves the
practice of medicine. Furthermore, a recent study showed
that approximately one-half of the medical recommendations
made by one set of famous physicians—those on medical
talk shows—had either no evidence or were contradicted
by the best available evidence, and they were rarely accompanied
by any disclosure of fınancial interests. 19 It is unclear
whether or not Congress has ever considered regulating
medical recommendations made on talk shows. This may be
of relatively little concern to HHS, since many of these recommendations
relate to medical interventions not covered
by Medicare or Medicaid.
Of greater concern is Congress’s failure to strengthen the
regulations and/or eliminate direct-to-consumer advertising
of medications, since patients may seek inappropriate medications
based on seeing (or hearing) such advertisements. 20
Although such advertisements are regulated in theory by the
U.S. Food and Drug Administration (FDA), their enforcement
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