Tulane University Site Team

Louisiana Experiment Assessing Diabetes outcomes (LEAD) study: Impact of Medicare Reimbursement Policy Supporting Chronic Care Management

Among Medicare beneficiaries, two-thirds have multiple chronic conditions, and the 23% of beneficiaries with five or more chronic conditions account for 68% of Medicare spending. A new policy went into effect on January 1, 2015, under which non-face-to-face care coordination services for chronic care management (CCM) are reimbursable by Centers for Medicare & Medicaid Services with a recently implemented CPT code (99490) for Medicare patients with two or more chronic conditions. The CCM services rendered under CPT code 99490 must consume at least 20 minutes of clinic staff time per month, may be supervised by physicians and certain non-physician practitioners, and must comply with the CCM Scope of Services.

The Louisiana Experiment Assessing Diabetes outcomes (LEAD) study employs a natural experiment design to examine the impacts of this health policy intervention on clinical and patient-reported outcomes in patients with type II diabetes plus at least one other chronic condition. The LEAD study will assess the reach, effectiveness, adoption, implementation, and maintenance of CCM services, based on the RE-AIM framework. The main study objectives are:

1. To evaluate the impacts of CCM reimbursement on diabetes outcomes (primarily glycemic control) and patient-reported outcomes (such as patient activation and experiences with care). Clinical and healthcare utilization endpoints include cardiovascular events, hospitalization, emergency room visits, and mortality.
2. To assess the uptake of CCM services within health systems and examine barriers to and facilitators for implementing and maintaining CCM services.

The LEAD study is led by Principal Investigator, Lizheng Shi, PhD., Vice Chair and Regents Professor in the Department of Global Health Management and Policy at the Tulane University School of Public Health and Tropical Medicine in New Orleans, Louisiana.

The study is being conducted in collaboration with Research Action for Health Network (REACHnet), one of 13 clinical data research networks that comprise the National Patient-Centered Clinical Research Network (PCORnet). The REACHnet Coordinating Center offers rich stakeholder engagement and informatics infrastructures through which patient-reported data collection, clinical dataset creation, and regular stakeholder advisory group meetings are efficiently conducted. REACHnet’s partner health systems participating in the LEAD study include Tulane University Medical Center, Ochsner Health System, Louisiana State University, and a consortium of Federally Qualified Health Centers in the Greater New Orleans area called Partnership for Achieving Total Health (PATH).

The study’s Steering Committee includes a co-investigator from each participating health system, two patient partners, a diabetes educator, econometric and qualitative methods experts, two payer organization representatives, and an endocrinologist and 2012 President of the American Diabetes Association – collectively bringing a multitude of expertise and perspectives to the conduct of the LEAD study.