NcXHF

MOY ET AL
Unfortunately, disclosure such as that mandated in the
Sunshine Act is far from a panacea in this context. Patients
need physicians’ guidance not only because they lack relevant
expertise to process complex medical information but also
because they are in an inherently vulnerable position when
making decisions about their own health. Patients may also
fınd their decision-making abilities compromised by the
symptoms of a serious disease such as cancer. Scholars have
questioned whether disclosure is a useful approach in general,
and the challenges appear particularly acute when considering
how best to manage conflicts of interest stemming
from physician–industry relationships. 59 It is quite unclear
whether patients can truly make appropriate sense of information
on physicians’ fınancial incentives or detailed disclosure
statements to determine the weight to give their advice
in various scenarios. 60-62 Similarly, although one could mandate
disclosure of industry spending on DTC advertising and
other promotional activities, it is unclear whether such
disclosure could serve as a meaningful check on this activity
in the way that unbiased physician participation might.
Although there are many opportunities for synergy between
industry and physicians, there are also many inherent
challenges that disclosure alone may be insuffıcient to
mitigate.
PERSPECTIVES FROM INDUSTRY
Collaboration and partnerships between pharmaceutical
companies and health care professionals/health care organizations
continue to be essential for the development of new
and life-saving treatments and medical innovations. Without
the engagement of medical researchers and practicing physicians,
for example, clinical research on new medicines would
be impossible. However, some of these partnerships have
raised concerns regarding potential conflicts of interest
where a physician’s professional judgments or actions regarding
a patient may be unduly influenced by relationships
with industry. As a result, greater and more detailed transparency
into these relationships has evolved over the past
decade.
Developing new treatments is the cornerstone of the pharmaceutical
industry. On average, nearly 20% of pharmaceutical
companies’ revenue is returned to conduct research and
development that leads to new discoveries. 63 The costs of administrating
complex clinical trials typically require high levels
of funding that are paid by industry. Physicians are
engaged not only to recruit, enroll, treat, and monitor patients
but also to design research protocols to scientifıcally
demonstrate effectiveness and/or superiority, promote wellbeing
in patients, and provide clues to the cost-effectiveness
of particular treatments and regimens.
Making the research space transparent is particularly
challenging because the majority of the payments made or
attributed to physicians and teaching hospitals are for reimbursement
of out-of-pocket costs associated with treating
clinical trial subjects and not for fees or compensation earned
by the physician or institution for their own work. In addition,
the Open Payments regulations require reporting of
“indirect” payments, such that physicians who may not have
a direct relationship with any particular pharmaceutical
company are still being reported as having received something
of value. These complexities, combined with the lack of
context, can paint a false picture for the layperson.
Indirect Payments and the Knowledge Standard
Indirect payments are payments or TOVs that are provided
to a third-party, noncovered recipient (i.e., not a physician
or teaching hospital) and then passed through to a covered
recipient. Examples of third-party arrangements that
might involve a pass-through to a covered recipient include,
but are not limited to, consulting fırm services (e.g.,
McKinsey, BCG), and contract research organizations
(CROs) arrangements (e.g., Quintiles, Parexel). When engagement
of a third party for services by its nature or by
virtue of the contractual terms contemplates or requires
the use of a covered recipient to perform the work, the
applicable manufacturer (AM; e.g., pharmaceutical, medical
device company, or group purchasing organization)
will likely need to track, attribute, and report some portion
of those payments as indirect payments to a covered recipient.
Because physician engagement is essential in many
research activities, the indirect payment provision’s effect
on the research space is signifıcant. As a result of this provision,
many CROs have created transparency divisions
with the sole purpose of providing data to AMs on the
breakdown of the (indirect) payments provided for research.
Steak Eaters, Stakeholders, and Principal
Investigators
CMS established $10/$100 (adjusted annually by the Center
for Program Integrity) as a de minimis of value transfer to
trigger reporting: small TOVs less than $10 do not need to be
reported except when the total annual value provided to a
covered recipient exceeds $100. The de minimis rule results
in the attribution of hundreds of thousands of transactions to
just as many physicians. The de minimis threshold is usually
not relevant for research, as costs for conducting clinical trials
and their corresponding payments are usually well above
the limit.
For research, payments are often made to third-party organizations
who then use the funds to conduct clinical trials.
In an effort to maximize research spend, most research-based
pharmaceutical companies look to third parties such as
CROs to conduct research associated with their products. By
working with multiple AMs, CROs achieve a level of effıciency
that any one AM would not be able to on its own.
Although it achieves effıciency, engaging a third party inherently
results in indirect payments between manufacturers
and the (covered) recipient of the funds. Furthermore, the
payments made by manufacturers, although based on detailed
line-item budgets, usually consist of reimbursements
and costs other than salaries or other fees paid to or received
134 2015 ASCO EDUCATIONAL BOOK | asco.org/edbook