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Medicare Modifiers:
The Impact on Clinical
Research
Susie Bullock, RN, MPH, OCN, CCRP
Manager
Clinical Research Support Center
MD Anderson Cancer Center
Overview
• History of CMS involvement in Clinical Trials
• Initial implementation of modifiers at MD
Anderson
• Required retraining
• Identified Concerns
• Future Directions
• New Findings
• Questions for Discussion
CMS Historical Involvement in Clinical
Trials
• June 7, 2000 executive memorandum
issued by the President of US
• Clinical Trial Policy (CTP) National
Coverage Determination (NCD) issued
by CMS
• Authorized coverage and payment of
the routine costs associated with
participation in a clinical trial.
Modifications of CMS Rules
• July 9, 2007 issued a memo that
preserves the 2000 NCD with a couple
of changes:
– Items that would be covered off protocol
should also be covered on protocol
– Evidence that the trial may work is
required.
Changes to the 2000 CTP
• Renaming of the policy to Clinical
Research Policy
• Process must be established that study
meets scientific and technical
standards:
– Subject of the study must fall within
Medicare benefit service.
– Must have a therapeutic intent.
– Must enroll patients with a diagnosed
disease.
Additional New Requirements
– Tx potentially improves health outcomes
– Well-supported by scientific & medical
information
– Does not unjustifiably duplicate existing
studies
– Is appropriate to answer the research
question
– Sponsored by a credible organization
– In compliance with Federal regulations
– Conducted with scientific integrity
The Introduction of Modifiers
• Effective 1/1/08 CMS mandated that
modifiers be placed on all qualifying
trials.
– This was not transmitted until 1/18/08.
– Trailblazers, our fiscal intermediary for
CMS, required immediate compliance.
– Resulted in our institution holding $38M+
of Medicare charges until a system was in
place.
Modifiers to be Used
• Instituted Q0, Q1, and R0 modifiers:
– Q0-investigational clinical service
• Items or services that are being investigated as
an objective of a study. This is regardless of if
the item is approved, unapproved, or
covered/not covered by Medicare.
– Q1- routine clinical service
• Standard of care procedures that are being
done to care for the patient. The services
would be done regardless of of the patient
being on a study.
Modifiers to be used, Cont.
• R0-investigational clinical services
– Services paid for by the sponsor.
• Considered a pivotal step by CMS to
better understand what investigational
and routine services are being billed
while a patient is on a clinical trial.
MD Anderson’s Initial Response
• New CSR (Clinical Service Requisition)
was developed that included columns
for modifiers.
• Fields were identified in the scheduling
system to accommodate the modifiers.
MD Anderson’s Initial Training
• Mandatory training classes began on
6/1/2008 for all involved in clinical research.
– At these trainings the new mandate was
discussed as well as consequences for
noncompliance.
– Introduction to the new CSR and scheduling
system
– Explanation of how to identify which modifier to
utilize
– New CSR was rolled out on 7/1/08
• After this initial training compliance was not
at expected levels.
MD Anderson’s Additional Training
• The GI Medical Oncology Department (GIMO) was
identified to have the best practice in place and had
excellent compliance.
• They were asked to join in retraining other
departments and share their processes.
• Training classes were held in each department
including research nurses, data coordinators, and
schedulers
• GIMO shared their internal auditing process as well
as “good” and “bad” orders to explain what needs to
occur to make an order clear to auditors, etc.
• Further concerns about the process were identified
and discussed.
Results of Retraining
• After the retraining the compliance rate
increased.
• Since this time we have worked toward
further compliance training thus ensuring
compliance
• At this time we still have a double-check
system in place. This will remain in place
until we have an effective electronic system.
Identified Concerns
o The need to have the research CSR
combined with the routine CSR for ease of
ordering and less paperwork to complete
o Manual entry of the modifiers and multiple
hand offs prior to increases the likelihood of
errors occurring.
o Rescheduling of appointments created a lot
of errors because the modifiers are not
“taken with” the appointment.
o Special lab tests that must be scheduled with
diagnostic center have been scheduled
without modifiers.
Future Directions
o Moving toward automating modifiers
into the protocol.
o Bringing Velos online within the institution will
help with automation
o Modifiers will be built into the procedure
completion screen in Velos which enables
automatic transmission to the billing systems.
o Electronic order entry with mandatory
modifiers or NA included
New Findings
o In the month of April 2010, we had our
first request from a commercial
insurance company for modifier
information.
o Since then we have had multiple major
insurance companies asking for this
data.
o We see this as a trend for the future
among all insurance companies.
Questions for Discussion
o What if any impact will state laws for
coverage of clinical trials have on
modifier reporting?
o How will the modifiers being provided
to insurers affect preauthorization for
participation in clinical trials?
The Perfect Rose
References
• CMS Manual System PUB 100-03
Transmittal 74 Dated 9/17/07
• http://www.cancer.gov/clinicaltrials/ctla
ws-home
• Meade&Roach LLP Compliance
Advisory: New CMS Research Modifier
Rules
• MD Anderson Cancer Center Clinical
Research Finance
Thank you
• Donna Griffith, RN- Clinical Research
Finance
• Mary Veazie, MBA- Clinical Research
Finance
• Yvonne Lassere, RN- GI Medical
Oncology