2004S-0170 - Medicare Prescription Drug, Improvement, and Modernization Act of 2003, Section 1013: Suggest Priority Topics for Research
FDA Comment Number : EC49
Submitter : Dr. Judith Baker Date & Time: 07/07/2004 05:07:22
Organization : Resource Group, Ltd.
Other Organization
Category :
Issue Areas/Comments
Resource Group, Ltd. appreciates this opportunity to submit comments regarding innovative research topics. We suggest that a vitally important topic today is evidence-based research performed to identify appropriate levels of providers' service delivery resource consumption.

An appropriate research design includes the following key steps:

- start with activity analysis,
- attach standard costs, and
- compare the research results to the applicable resource-based site of care payment methodology currently in use.

Attached please find a study titled 'A Cost Analysis of Office-Based Non-Chemotherapy Infusion Therapy Services: Policy Implications and Recommendations' (October 7, 2003) that follows this research design. In this study, the Resource Group, Ltd., observed infusions of 100 patients in 94 physicians' offices. The administration of infused non-chemotherapeutic biologic therapies took place in 50 rheumatologists', 25 gastroenterologists' and 19 infectious disease specialists' offices.

The study paralleled the Centers for Medicare and Medicaid Services' (CMS') resource-based practice expense methodology. The in-depth resource utilization observational study incorporated CMS' own activity descriptions. The observations were supplemented with staff interviews to capture additional detail and information not available through direct observation of infusion procedures. Costs were attached to the resource consumption data using the CMS cost pool methodology. The analysis then compared the cost of providing office-based non-chemotherapy infusions to the current Medicare fee schedule.

In conclusion, we suggest that research performed to identify appropriate levels of providers' service delivery resource consumption is an important issue in today's world of health care. Such research will serve to better inform policy-makers' discussions and decisions.