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 & 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 UKCRO.
For more
information, contact
Marietta Barton Baxter at (859) 257-3240,
UKCRO 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.
- Hospital policy "Clinical Research
Accounts for Hospital Purchases"
www.hosp.uky.edu/policy
-
Send either
the Institutional Account Create Form or
the Plan Code Create Form electronically
to Will Swiney at
WRSWIN2@EMAIL.UKY.EDU.
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) 257-7910
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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