|
absent procedures that
occurred well before the first participant was enrolled. In addition
systems must be available and adhered to in order to ensure proper
billing. Without careful attention to these
issues, the University of Kentucky (UK) could be accused of wrongly
billing third party payors like Medicare, Medicaid and private insurance
for clinical services administered to patients in clinical trials.
Several federal agencies are concerned and are monitoring how health
care facilities are managing this process. Infractions may lead
to government enforcement actions which could result in costly fines of
the UK Medical Center, harm to individual clinical investigators and
disruption of clinical research and patient care.
Training
Requirements for UK Personnel Involved in Clinical Trials
For the purpose of billing and fiscal
compliance, the scope of this education program and associated
procedures apply to research studies that involve human subjects and
billable routine and research services regardless of funding source.
The Education Committee
has identified the target audience and developed four (4) educational
modules and one (1) Workshop (in development). The Committee has further drafted a
faculty and staff training
requirements
grid to designate which modules are mandatory for each
section of the audience. The target audience is identified by title but
includes any staff that performs designated functions irrespective of
title. Note that some individuals may serve multiple roles and
therefore may need to attend more educational Modules.
This Clinical Trials Fiscal
Training Program will be mandatory for all current and future staff and
faculty who serve as principal and co-investigators, budget preparers,
clinical coordinators, clinical research associates, budget managers,
coders of research procedures or services, departmental business
managers (suggested), and chairs of departments (suggested)
participating in clinical research. This training program includes
Center for Medicare (CMS) guidelines, newly
established policies and procedures for subject registration, a more
uniform process for budget preparation and financial management,
appropriate billing modifiers, Medicare, Medicaid and third party
insurance coverage, and instructions on tools and forms available to
enhance compliance. Implementation of the new processes in various
departments is recognized as an evolutionary process. Results will be
monitored for effectiveness and revised or tailored as appropriate.
Resources:
Applicable UK staff and external consultants have
been identified to spearhead curriculum development and/or conduct
training based on content and area of expertise. These individuals have
sought input from clinical research personnel from a variety of
therapeutic areas in order to develop curriculum content that is both
applicable and useful. Web based modules may be developed to replace
classroom sessions once the majority of personnel have been trained and
evaluation of the educational sessions are completed.
Contacts from each of the units contributing to
development of these trainings sessions including, OSPA, UKCRO, ORI,
Compliance, Patient Accounts, KMSF, etc will be available for ongoing
support and consultation.
The
fiscal compliance officer
(TBN)
in the corporate compliance office,
will be
available to answer questions regarding Medicare Coverage Analysis for
protocols that meet the criteria for Medicare reimbursement. In addition, he/she
will monitor the current system to promote compliance with fiscal
regulations and provide consultation or guidance as needed.
The
UKCRO education coordinator
will initiate and
maintain the web based trainings, coordinate class sessions and track
personnel completing the trainings.
All
involved personnel and trainers will
provide resource information, tools, manuals, FAQ's, etc. UKCRO will
also develop and maintain a resource website to house these resources.
Format
of Clinical Trials Training:
This Educational
program will consist of an overview of Research and Fiscal Compliance
followed by three more detailed classroom sessions that provide
information and explanations on implementing new CMS guidelines and
internal procedures.
All individuals involved in clinical trials,
especially industry supported clinical trials that require clinical care
billing and research billing will be required to complete at least some
of the modules as described below. This also includes staff in the
hospital, clinics and clinical departments involved in patient billing
and compliance on such trials.
Faculty and staff will be given a reasonable time
period to complete the training. Principal Investigators and Budget
Preparer/Mangers must complete required training within a designated
timeframe. After the grace period, no new externally funded clinical
trial account will be established without a trained PI and Budget
Preparer/Manager. UKCRO will keep records of training session attendees
and will serve as back-up budget preparers as needed.
|
