A highly critical report from the Department of Health and Human Services Office of Inspector General (OIG) characterizes data from the Medicare 2005 chemotherapy demonstration project as unreliable due to inconsistent data collection methods. The 12-month-long project is on track to cost about $275 million, making it by far the most expensive research program undertaken by the Centers for Medicare & Medicaid Services (CMS). Because CMS did not waive the 20% beneficiary coinsurance, patients paid about $55 million of the project’s cost. The OIG analyzed demonstration project claims that CMS had received through the end of 2005.
Under the 2005 demonstration project, office-based physicians could bill $130 for visits at which a patient received chemotherapy by infusion or push for a cancer diagnosis—if the office reported an assessment of the patient’s nausea and vomiting, pain, and fatigue. Demonstration project codes described on a 4-point scale the degree to which the beneficiary experienced each of these 3 conditions.
A major reason for the unreliability of the data is that CMS did not specify how to collect information. Therefore, oncology practices used varying methods. This limits the usefulness of the data. For example, one nurse told the OIG that if a patient had vomited several times in the past week but was feeling fine on the date of the assessment, then she would report the lowest level of nausea and vomiting. Another practitioner legitimately could choose to report the highest level, based on the patient’s symptom during the prior week.
CMS did not require participants to document demonstration assessments in the patient’s medical record. Therefore, CMS cannot verify the accuracy of the data. CMS provided no list of valid diagnostic codes for the demonstration; lists developed by carriers varied.
The OIG also found that Medicare overpaid $17 million in demonstration claims because of issues such as duplicate billings, reimbursements for demonstration activities not performed concurrent with chemotherapy, and payments for services associated with patients not diagnosed with cancer.

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