November 2024 SOCRA Source Journal - Journal - Page 24
and payments. Despite their
differences, both areas share
common documents such as
budgets, contracts, tracking
systems, electronic medical
records (EMRs), and reports.
Therefore, it is imperative
for compliance teams to be
pro昀椀cient in both 昀椀nancial and
patient billing compliance.
The consequences of neglecting
昀椀nancial and patient billing
compliance can be severe for
clinical research sites. Risks
include inappropriate patient
billing, discrepancies in study
charges, potential regulatory
violations leading to 昀椀nes,
and adverse impacts on site
operations and reputation.
Failure to adhere to patient
billing compliance principles
may result in dealing with
Medicare audits and penalties.
Moreover, sites may face
昀椀nancial losses due to missed
deadlines for invoicing and poor
昀椀scal management practices
which include missed revenue
and uncollectible accounts
receivable, which have led to the
closure of clinical research sites.
Other 昀椀nancial risks to consider
are paying incorrect stipends
to research participants and
improper reimbursement.
During audits, the author noted
multiple errors for stipends to
research participants. Stipends
are dif昀椀cult to manage due to
silos at clinical research sites.
Different people often negotiate
the study budget, enter data into
the clinical trial management
system, and include patient
stipend or reimbursement details
in the informed consent form.
It is also necessary to ensure
document concordance extends
to technology tools.
24
A Mitigation Approach
To mitigate problems stemming
from inadequate 昀椀scal and
patient billing compliance,
various controls can be
implemented within a research
compliance plan. This plan
should outline what needs to be
reviewed, who will perform each
task, how tasks will be executed,
and when 昀椀nancial and billing
compliance will be assessed.
Clinical research professionals
are familiar with annual
research compliance plans
focusing on human subject
protection. Similarly, they
should become well-versed in
the 昀椀nancial and patient billing
compliance sections of such
plans. Incorporating 昀椀nancial
and patient billing compliance
into the annual plan creates
opportunities for training, akin
to the education provided for
human subject protection. This
ensures consistency across the
organization and fosters a culture
of compliance and continuous
improvement.
The research 昀椀nancial and
patient billing compliance
plan should involve key
stakeholders, including
compliance and 昀椀nancial
leaders, and key research
personnel. The development
and implementation of the plan
requires thorough consideration
of the accounting aspects of
the research program and
a commitment to ongoing
re昀椀nement. By reporting
monthly, quarterly, or annually on
the 昀椀nancial and patient billing
reviews, a 昀椀nancial scorecard will
be attained for the site.
As the plan is conducted, it will
present training for compliance
teams in both 昀椀nancial and
patient billing compliance for the
protection of sites and patients.
SOCRA SOURCE © November 2024
Developing the Research
Financial and Patient Billing
Compliance Plan
The initial development
of a research 昀椀nancial and
patient billing compliance
plan may be time-consuming,
requiring careful deliberation
and coordination among
stakeholders. Implementation
can also pose challenges,
as change management is
inherently dif昀椀cult. The iterative
process of planning, reviewing,
implementing, changing,
updating, and reviewing again,
is essential for continuous
improvement.
The plan should encompass key
components, including:
•
•
•
Introduction: Providing
an overview of the clinical
research site, the purpose of
the plan, 昀椀nancial policies,
and reporting concerns.
Include policies that are
system wide for the site as
teams may not know the
institutional policies related
to 昀椀nancial areas. Include
non-compliance as a policy.
Roles and Responsibilities:
De昀椀ning the roles of
compliance team members
and outlining an education
plan to ensure clinical
research professionals
understand the site’s
policies and expectations.
Encourage the compliance
team to work alongside the
operation teams.
Audit Procedures: Detailing
the types of audits, annual
and close-out plans, and
reporting objectives. The
annual compliance plan
should be reviewed with the
operation team leaders to
incorporate preparation for
the annual reviews.
