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Fiscal
Compliance in Clinical Trials Education Program |
Program
Description
Module/Class Overview
Faculty and Staff Training Requirements (per job function/unit) |
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Training Modules
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Module Outline and Objectives
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Module Class Schedule
(coming soon)
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Supplemental Web Based Training Resource-
University of Kentucky:
Third
Party Reimbursement for Medical Services related to Clinical Trials
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The information
below serves as a quick reference guide to augment the
Fiscal Compliance Education Program |
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Third Party
Reimbursement for Medical Services related
to Clinical Trials: Guide for Billing
Medicare
Developing a Project Budget, Establishing a
Research Plan Code and Conducting a Medicare
Analysis
Managing Study Costs and Payment
Contacts
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Third Party Reimbursement for Medical
Services related to
Clinical Trials:
Guide for Billing Medicare. (This
section provides a reference guide
for the information
presented in the Module I training session.)
(coming soon) |
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Developing a Project Budget, Establishing a Research Plan Code and
Conducting a Medicare Analysis
(This
section provides tools used and demonstrated in the Module II and III training
session.) |
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The
principal investigator (or their designee) is responsible for developing
an adequate project budget and for negotiating a budget with the
sponsor. Note:
Principal
Investigators and Budget Preparer/Mangers must complete
required training within a designated timeframe in order to
establish an account for new externally funded clinical trials. |
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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.
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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.
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Without a properly prepared & negotiated budget, you and your institution
stand to lose money on a clinical trial.
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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
Shirley Warren (859) 323-8148, UKCRO Initiation
Manager.
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.
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:
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Determining whether the study is a qualifying clinical
trial
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Performing an analysis of each item and service to
determine Medicare coverage under Medicare regulations
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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.
Medicare Analysis Forms
In order to initiate a Medicare Coverage Analysis, the PI or
appropriate study staff should complete the following Forms:
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Form Section A: Qualifying Clinical Trial Analysis
This worksheet will help you to determine if your trials qualifies
for Medicare coverage under the Medicare Clinical Trials 2000
National Coverage Decision
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Form Section B: Study Identifying Information
This worksheet
details study identifying information and serves as a study summary
for qualifying trials.
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Form Section C: Investigational Item or Service Analysis
This worksheet will help you to determine what items and services as
part of a Medicare qualifying trial are billable to Medicare under
the Medicare Clinical Trials 2000 National Coverage Decision.
Medicare Analysis Appendices
(Medicare Device Coverage Checklist;
Anti-Cancer Exceptions; General Coverage
Principles)
When all forms are complete, please submit to
Nikki Lawhorn, with the
following items:
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Roles Delineation Form
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Protocol Schedule of Events
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PI signed Research/Routine Care worksheet
(or schematic sighed by the PI, with
R/RC clearly designated)
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Informed Consent Document*
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Budget Documents
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Clinical Trial Agreement*
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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 MA, but a review of the analysis should be conducted when
all study documents are finalized.
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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Managing Study
Costs and Payment (These sections provide
information and tools to augment Modules II and III of
the Fiscal Compliance Education Program)
Sponsored Projects Accounting (SPA) in the Office of the
Controller submits invoices to grant sponsors and monitors cash
receipts. However, because payment for clinical trials is based on
submission of patient data to the sponsor, invoicing and cash management
is administered differently. The department is responsible for
submitting appropriate data to the sponsor, recording the dollar amount
as an "amount due," recording the receipt of payment and depositing
checks in the appropriate grant account.
http://www.uky.edu/eForms/forms/checktran_sap.pdf
Additional tools to assist with this responsibility are under
development, but key points for establishing a fiscal management system are
listed below:
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Establish a patient activity log based on a protocol/contract
reimbursement schedule
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Charge research-related costs to study account using "green card/institutional
account" or "plan code"
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Invoice the sponsor per payment schedule
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Record the receipt of checks and deposit promptly
www.uky.edu/Regs/BPM
(also termed WBS element)
section E-2-4
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Send copy of check transmittal form to
OSPA
to increase study account budget
http://www.uky.edu/eForms/forms/checktran_sap.pdf
To properly manage the finances of a clinical trial, it is vital to distinguish
between research-related costs (R) and costs that are "routine care" (RC).
Research costs should be charged to the study account using the
"green card" or "plan code" and should only be billed to a third party payor
when appropriate. Only procedures that
are "routine care" (i.e. care and treatment that would have been performed as a matter of
routine care in the absence of a clinical trial) may normally be charged to
third party payors (government or private).
Next analyze items and
services in the research protocol to
determine if billable based on medical
necessity. CMS publishes coverage decisions
that establish criteria for medical
necessity for specific patient care
services. Frequency for service and
condition or indication is also considered.
The fiscal compliance office can assist in
identifying such decision as part of the
Medicare Coverage Analysis.
In addition, even when the
care provided is determined to be "routine care" the related charges are
properly billable only if the sponsor has NOT provided for payment of the
services in the contract. Regardless of the nature of the care
provided, charges reimbursed by the sponsor may not be billed to any third
party. In addition, items and services promised free of charge in the
informed consent form may also not be billed to Medicare and other 3rd party
payees.
Remember that the use of a device in a study raises
additional reimbursement issues based on, among other things, the use
and/or category of the device. Such reimbursement issues involve
not only the device itself, but also care and treatment related to the
device. Further information regarding device studies is being
prepared.
The investigator and department must be constantly
vigilant in their efforts to charge the appropriate source for patient
care costs. If a cost is charged to a third party payor in error,
Patient Accounts and/or Kentucky Medical Services Foundation (KMSF)
must be contacted immediately to help correct the mistake and make any
necessary repayment. Failing to do so can result in serious
criminal, civil, and administrative liability for both the individuals
involved as well as for the University.
Helpful budget
management resources:
Managing
the Study
Account
All sponsored project
accounts (study accounts) are established by Sponsored Projects
Accounting based on information provided by the OSPA. The
documentation necessary to establish an account is addressed below.
Because industry-sponsored clinical trials have some unique
characteristics, a number of administrative accommodations have been
made to facilitate proper management. That information is also provided
in this section.
Documents Required to
Establish a study account for a Clinical Trial
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A study account for a clinical trial will be established when the
Institutional Review Board (IRB) has approved the study and these
documents are completed and forwarded to OSPA: a copy of the
study protocol, a clinical trial agreement signed by OSPA
and the company, a signed Internal Approval Form
http://www.uky.edu/eForms/forms/intapprv.pdf,
signed Disclosure
Financial Interest Form(s)
http://www.uky.edu/eForms/forms/discfin.pdf,
Fixed-Price Agreement Budget Form
http://www.uky.edu/eForms/forms/fixprice.pdf
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If all other documents are available but
IRB approval is pending, an account may be established with a
certification by the Principal Investigator that no recruiting will take
place until approval is received.
Grant Budgets for Clinical
Trials
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Study account budgets are normally established based on the amount
committed by a sponsor in an awards notice or contract. For
instance, if an award notice from the National Institutes of Health
commits $50,000, the ledger 4 account will have a budget
for $50,000. Most clinical trials are funded on a "per patient"
basis up to a maximum number of patients. Recruitment of the
maximum number of patients is not assured and payment is based on actual
activity. Therefore, study grant account budgets for clinical
trials are established based on actual activity.
Therefore, study accounts
for clinical trials are established based on actual cash receipts.
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Throughout the study as funds are
received, the department will deposit checks
via a
check
transmittal into the income ledger associated with the
study account. The gl account for grant cash is 245002.
Attach any documentation that accompanied the check to the
transmittal. Ideally, the documentation will identify the study and
the Principal Investigator. Deposit the check in accordance with
Business Procedures Manual section E-2-4. Retain a copy of the
transmittal in the department and forward a copy to OSPA.
OSPA will then increase the Study account by the amount of cash
received which is reflected on the PADR.
Adverse Event Payments
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Sponsors of clinical trials should pay for costs
associated with adverse events due to study participation.
Adverse events could include
emergency room visits, extra physician visits, additional diagnostic
tests, etc. These costs are research-related and should be charged to
the research account.
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If the costs are
incurred at UK, the patient specific plan code card should be used. If
the costs are incurred elsewhere, payment may be made by DAV based on an
invoice from the care provider. The department must seek reimbursement
from the sponsor plus UK overhead, deposit the reimbursement check in
the study account and send a copy of the check transmittal to OSPA.
OSPA will then increase the budget by the amount of cash received.
Time Extensions
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Clinical trial
agreements almost always include effective dates.
If the sponsor extends study activity, they usually issue an
amendment to the agreement to change the ending date and the study
account will be extended based on the amendment.
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There are also
times that the sponsor does not wish to extend the agreement but
project related activities continue to take place.
This could include patient follow up, continued data submission
and audit, queries and resolutions, and ongoing reconciliation of
financial reimbursement. If project activities continue, the
Principal Investigator should request an extension of the account by
submitting a request to OSPA on this form
http://www.uky.edu/eForms/forms/action.pdf
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If project
activity has ceased but the sponsor has not made final payment, the
date for financial close out by accounting should be extended to
allow cash to be deposited appropriately. The department should
notify OSPA of the date they expect final payment and the
financial close out date will be extended.
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Every effort
should be made to extend the financial close out date
if payment is outstanding. However, when a late check is received
unexpectedly, the department should contact the manager of Sponsored
Projects Accounting to discuss deposit of the check.
Fixed-price Agreements and
Residual Cash Balances
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Most clinical trial
agreements are funded on a "fixed-price" basis.
A budget is negotiated between the investigator and sponsor for a
specific amount per completed patient. At times, lesser amounts are
paid for patients that do not complete the protocol. It is important to
charge all grant related costs to any sponsored account and clinical
trials are no exception. The actual costs of conducting the project
should be charged to the study account including the investigator's
time, other personnel, supplies, research-related patients care costs,
etc.
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At the
conclusion of the project, the cash received may exceed the actual costs
incurred to do the project. Note: If all of the cash has not been
received the department should request an extension of the fiscal report
date. When all the cash has been deposited and all applicable direct and
indirect expenditures have been properly charged to the study account,
the remaining cash balance may be returned to the department and
investigator. The University policy regarding fixed-price agreement is
Appendix I to ARII-1.0-3
Contacts:
Refer to the Administrator index
or call the Office
of Sponsored Projects Administration (859) 257-9420 and ask for the
Administrator assigned to your department.
Other Issues
Personal Awards
University employees may not accept personal
remuneration from a sponsor for activity related to the project. This
could be cash, travel, gift certificates or other form of remuneration.
Payment for activities related to University employment should be made
through salary reimbursement or approved overload. This issue is also
addressed in the Medical Center's Corporate Compliance program manual
under kickbacks/illegal remuneration, chapter 3.
General Guidelines
for Salary Allocations
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Contacts
Revenue Management:
Hospital Discount questions
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Name
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Ruth Hancock
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Email
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rshanc2@email.uky.edu
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Department
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Revenue Management
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Address
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Ste 400, 2317
Alumni Park Plaza, Lexington, Kentucky 40517 |
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Phone
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859 323-1489
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Fax
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859 257-8071
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Kentucky
Medical Services Foundation:
Physician discount,
billing questions
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Name
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Marcia Atwell |
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Email
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marciaa@kmsf.org
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Department
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Kentucky Medical Services Foundation
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Address
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138 Leader Ave., Lexington, KY 40508
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Phone
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859 257-7910 Voicemail: 859 257-8675
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Fax
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859 257-8675 |
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Patient
Accounts:
Hospital billing questions
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Name
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Kim Kidd
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Email
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kdkidd@email.uky.edu
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Department
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Patient Accounts
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Address
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2317 Alumni Park Plaza Suite 400,
Lexington Kentucky 40517
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Phone
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859 257-8074 ext.283
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Fax
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859 257-8071
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Name
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Sandie Hammond
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Email
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schamm2@email.uky.edu
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Department
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Patient Accounts
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Address
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Ste 400 2317 Alumni Park Plaza, Lexington Kentucky 40517
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Phone
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859 257-8168
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Fax
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859 257-8071
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Name
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Will Swiney
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Email
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wrswin2@uky.edu
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Department
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Patient Accounts
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Address
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Ste 400 2317 Alumni Park Plaza, Lexington Kentucky 40517
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Phone
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859 257-6180
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Fax
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859 257-8071
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Office
of Sponsored Projects Administration:
(OSPA)
Research
Administrators/per department
Industry
Clinical Trial Agreements
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Name
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Michael B. Brown |
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Email
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michael.brown2@uky.edu |
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Department
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Sponsored Projects
Administration |
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Address
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201 Kinkead Hall
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Phone
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859 257-5714
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Fax
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859 257-8298
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Sponsored
Project Accounting
www.uky.edu/VPAdmin/Controller/spahome/
Confidential
Disclosure Agreements
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Name |
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Donald Keach |
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Email |
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dkeach@email.uky.edu |
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Department |
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Intellectual
Properties |
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Address |
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A148 ASTeCC Building 0286 |
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Phone |
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859 257-2300 x230 |
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Fax |
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859 323-1074 |
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Anesthesia:
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Name
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Cheryl L.
Harrison |
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Email
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clharr3@uky.edu
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Department
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Advanced Surgery
Center |
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Address
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G300 Gill Building
0294 |
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Phone
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859
323-6096 |
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Fax
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Clinical
Laboratory:
Endoscopy:
General
Clinical Research Center
(GCRC):
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Name
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Abby Cosentino
Boehm |
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Email
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abby.cosentino@uky.edu
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Department
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Clinical
Research Center
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Address
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Mn578
AB Chandler Medical Center 0293
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Phone
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859-323-7939
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Fax
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859-257-9560
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Investigational
Drug Service:
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Name
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Stephen Sitzlar
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Email
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scsitz0@uky.edu
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Department
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Investigational
Drug Service
- Pharmacy Administration
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Address
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HC 212 Medical Center 0293
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Phone
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859
323-2894 (pager 323-3000, #2688)
Long
Distance Beeper - 1-800-329-3514
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Fax
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859
323-2049 |
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Kentucky
Medical Services Foundation:
Demographic Re | | |
