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How should we spell success?
Questions of how we define success in cancer research and how costs should factor into that definition have been much in the news.
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The War on Cancer: Raise the bar, or move the goal line?
Plenary Session
SWOG Fall 2009 Group Meeting
Friday, October 23, 12:15 - 2:45 pm
Gold Level, Regency B - D
Hyatt Regency Chicago
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Q modifiers and the role of the Clinical Research Associate
-- by Aermonia Nazaretyan, BS, and Amy DeBlaise, BA, CCRP
As of January 1, 2008, the Centers for Medicare and Medicaid Services (CMS) have created two new modifiers to differentiate between routine and investigational clinical services.
Q0 -- identifies investigational clinical services provided in a clinical research study
Q1 -- identifies routine clinical services provided in a clinical research study
Medicare contractors (hospital, lab, X-ray, physician) for Part A and Part B are required to submit data to CMS to help track the different clinical research services providers are billing to Medicare. Under the new modifier rule, CMS is emphasizing the importance of coordination among providers and study sites.
The Q modifiers will help CMS understand what investigational and routine services are being billed during specific research studies. They'll also help CMS compare different institutions' billing practices for the same research study. This can help hospital corporations build and manage study budgets by standardizing research policy and practice.
Patient scenarios
Patient A comes in for an outpatient mammogram that is unrelated to the research study. Do not include modifiers on the line for mammograms. If the claim includes other charges that are part of the research study, identify those charges with the appropriate Q modifiers.
Patient B is in a cancer research study. The sponsor is paying for the drug, and all other charges are standard of care. You should not include the drug since the sponsor pays for it, but report all other charges with Q1 modifiers. (If it is necessary to report the drug in order to suppress system edits, then the drug should be reported with non-covered token charges with any appropriate non-covered modifiers.)
The most common service within cooperative group research is the use of Q1 modifiers for patients on clinical trials that use standard-of-care practice to develop protocol therapy.
Collaboration among providers and physicians
Patient C is enrolled in a research study and the hospital identifies this patient as participating in a study. CMS can access this patient's claim form and check to see if the physician is billing accordingly by assigning the same modifiers.
In conclusion, in order to comply with the CMS regulations, providers should consider the following actions:
- Develop a process to analyze each research study that sorts the protocol-required services as "investigational" or "routine" clinical service.
- Adopt a process to appropriately place modifiers on claims.
- Begin a clinical research billing compliance initiative to build safeguards for accurate billing.
- Always consult with your organization's Medicare liaison.
- Identify studies that are active with multiple sites and collaborate with those sites to organize a guide that identifies which services should be coded as Q0 or Q1. The Southwest Oncology Group should lead this process to develop these guidelines to help CRAs in the field.
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