Developing a Project Budget
The goal of clinical trial budgeting is to
project costs that accurately reflects the
time, effort and material required at a fair
market value to carry out the protocol.
The study budget consists of all direct
costs, personnel effort, interdepartmental
services, facilities and administrative
costs (indirect or overhead), pass-through
costs and any cost sharing commitments.
-
Surveys have shown as little
as 6% of clinical trials are completed
on budget and on time; careful attention
to development of the budget at the
front end is warranted.
-
Without a properly prepared and
negotiated budget, you and your
institution stand to lose money on a
clinical trial.
-
As a fixed price agreement, you are
obligated to perform the work (accrue
subjects) described in the contract even
if costs exceed contracted dollars.
The
following tools and forms are provided to
assist in accurately
identifying appropriate tests per the study
protocol, developing the budget,
establishing research discounts and the
study plan code.
TOOLBOX
Budget Development Services
Budget Development services
are also available on a
cost recovery basis
from the CRDOC.
For more information, contact
Abby
Cosentino
at (859) 323-7939, CRDOC Assistant Director.
Establishing a Research Plan Code
The Research Plan Code is a mechanism used
to register and identify research patients
for billing purposes. Under the
Research Plan Code system, all research
patients have 9777 or 9778 appended to their
suffix case. The plan code identifies
the study’s research account as the primary
payer and if applicable, other third-party
payors as the secondary payor.
If
you have registration resources available
for your subjects, you are encouraged to request
a research plan code instead of an
institutional account.
Budget and Plan
Code Contacts:
Hospital Discount Questions:
Revenue Management:
Ruth
Hancock 323-1489
Physician Services Billing Questions:
Kentucky Medical Services
Foundation:
Marcia
Atwell
(859) 218-5713
Hospital
Billing Questions:
Patient Accounts:
Kimberly
Kidd (859) 257-6128
Sandie
Hammond (859) 257-8168
Will
Swiney
(859) 257-6180.
Conducting a Medicare Analysis
The Primary objective of a Medicare Analysis
is to ensure that a plan is set in place
such that all costs of a clinical trial are
billed to the appropriate payor whether it
is the sponsor, a third-party payor or the
patient. Meeting this objective
requires an evaluation of a study to
determine what items and services listed in
the schedule of events are billable to
Medicare and other third party payors.
Conducting a Medicare analysis is important
because it ensures items/services are
designated to be charged to the appropriate
payer, helps evaluate if a budget is
realistic, delineates subject financial risk
and documents due diligence.
Conceptually, the Medicare Coverage Analysis
can be broken into three stages:
-
Determining whether the study is a qualifying clinical
trial
-
Performing an analysis of each item and service to
determine Medicare coverage under
Medicare regulations
-
Conducting an analysis of study documents to ensure
supporting documentation does not negate
Medicare coverage.
POINTS TO REMEMBER ABOUT MEDICARE
Medicare is a chronic care program, not a
preventative care program. Medicare
does not base its coverage decisions on
preventative care, evidence-based medicine,
or outcomes data. Medicare
decisions are not judgments on clinical
practice and should not interfere with
clinical judgment or practice.
Medicare decisions are simply payment
determinations.
Medicare makes coverage decisions based on
the types of services provided, frequency,
and indication. Medicare covers two
types of items and services, those that are
reasonable and necessary to treat an illness
or injury and a very limited
number of preventative care services.
It takes an act of Congress to approve
Medicare coverage of preventative care items
and services.
Helpful resources:
Timing of a Medicare Coverage Analysis.
Ideally, an initial Medicare analysis
should be done parallel with budget
development so that budget negotiators
know what items and services can
appropriately be billed to Medicare.
Conducting a Medicare Analysis at this
point helps to ensure that the study
sponsor adequately covers study costs.
If, as recommended, a Medicare Analysis
is conducted before the IRB approves the
study and the Clinical Trial Agreement
is fully executed, the Medicare Analysis
should be reviewed to ensure the
contract and informed consent do not
agree to cover the cost of any item or
service that was designated to be
charged to Medicare or other third-party
payers.
In order to initiate a Medicare Coverage Analysis, the PI or
appropriate study staff should complete the
following Form:
Medicare
Analysis Form
Medicare Analysis Appendices
(Medicare Device Coverage Checklist;
Anti-Cancer Exceptions; General Coverage
Principles
When all forms are complete, please submit
to
Rebecca Scott, with the
following items:
-
Protocol Schedule of Events
-
PI signed
Research/Standard of Care worksheet
(or schematic sighed by the PI, with
R/RC clearly designated)
-
Informed Consent Document*
-
Budget Documents
-
Clinical Trial Agreement*
-
Other study supporting documents such as letter from FDA
setting out IND status or device
category, journal articles supporting
conventional care status,
etc.
*drafts are acceptable for the initial
MCA, but a review of the analysis should
be conducted when all study documents
are finalized.
Electronic submission is acceptable.
Please keep a signed copy of the
Research/Standard of Care Worksheet in the
appropriate study binder. Please
contact
Rebecca Scott with any questions
regarding the worksheet, the form or the
Medicare Coverage Process.
Special
Consideration for Device Studies
A. All
investigational and non-investigational
devices must be submitted for review and
approval of the Technology Assessment
Committee. Complete the
request
form and submit with protocol and
other supporting documents. If you
have questions regarding your submission,
contact
Lorra Miracle, RN, Value
Analysis/PI Facilitator/UHC Liaison at
323-4745 or pager 2706.
B. The use of
a device in a study raises reimbursement
issues based upon the category of the
device. Category B devices, as well as
the hospital and physician services
surrounding these devices, may be reimbursed
by Medicare for Medicare patients.
C. Category A
devices that are used to treat an immediate,
life-threatening condition, (defined as a
stage of disease in which there is a
reasonable likelihood that death will occur
within a matter of months or in which
premature death is likely without early
treatment), may also qualify, but the device
will remain non-covered.
To receive
reimbursement, the Hospital must gain
approval from the Medicare Medical Director.
This process is coordinated through the
Managed Care Finance department of the
Hospital. The information listed below
must be submitted and approved by Medicare
before enrolling any study patients.
The Medicare approval process ranges from
four to six weeks in duration. Contact
Elaine Younce
for more information on devices at (859)
257-9521.
- The name
of the device (trade name, common or
usual name, and classification), and a
detailed narrative description of the
device.
- A signed
copy of the request for FDA approval
letter.
- A signed
copy of the FDA approval letter
demonstrating Category B*, IDE status
and approval from the FDA to the
participating company or manufacturer.
- A copy
of the protocol you intend to follow
when performing the procedure utilizing
the Category B*, IDE device and a
summary of the results of patients who
have undergone the procedure(s)
described within the protocol.
- A copy
of the agreement between the company or
manufacturer and the provider,
furnishing the details of provider
participation in the study.
- Copies
of at least two peer-reviewed
publications (abstracts not acceptable)
addressing the topic of the study.
- Any
product literature illustrating the
device and/or the procedure.
- The name
and model number of the specific FDA
approved device for the same medical
condition that the new IDE is replacing.
- A copy
of the protocol used for obtaining
informed consent from beneficiaries for
their participation in study.
- An
institutional review board approval
letter or a statement from the provider
assuring that approval has been obtained
form the study institution.
- Provide
the FDA IDE number.
- The
number of cases the institution has been
approved.
- Who is
the contact regarding the IDE portion of
the study?
Category B
devices are those types of devices that are
newer generations of proven technologies.
Initial questions about the safety and
effectiveness of these devices have been
resolved. Devices placed in this
category are considered to represent
evolutionary changes in proven technologies
and will be reviewed as potentially
reasonable and necessary by Medicare, and
therefore, eligible for consideration of
coverage and payment as long as device
procedure is a recognized benefit category.
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