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 Transmittal 74 Dated 9/17/07 ws-homehttp:// 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