Part 1. Impact on Management of Patients with Diabetes Mellitus (continued)

Introduction

In 2002, new Current Procedural Terminology (CPT) codes were established to allow providers to indicate when behavioral therapies were employed specifically for treatment of general medical disorders. In response, regional Centers for Medicare & Medicaid Services (CMS) carriers expressed interest in developing appropriate coverage decisions, accounting for available scientific evidence. CMS, through the Agency for Healthcare Research and Quality (AHRQ), requested the Duke Evidence-based Practice Center (EPC) to perform an evaluation of the evidence regarding a limited group of potential circumstances for the use of behavioral therapies for general medical disorders.

The new health and behavior codes (Appendix A) concentrate on assessments and interventions aimed at improving physical health. The focus of the current analysis is thus on physical health status. Potential intervention targets cover a wide range of possibilities including patient adherence to general medical treatment, symptom expression, health-promoting behaviors, health-related risk-taking behaviors, and overall adjustment to general medical illness. In conjunction with the CMS regional carrier medical directors, three medical conditions were selected for systematic review, based on their clinical importance and their representativeness of the variety conditions for which behavioral therapies are commonly considered. This technology assessment focuses on the first condition selected: diabetes mellitus.

Framework of the Technology Assessment: Efficacy in Terms of Clinical Outcomes

This review was designed to answer the following analytic question: Do behavioral interventions for individuals with diabetes result in improved physical health outcome(s), compared with control interventions? The specific effort focused on behavioral therapies presumed to improve health outcomes by improving adherence by patients with diabetes mellitus (e.g., in recommended use of insulin and other medications, diet, exercise, and so on). The specific clinical outcomes of interest included the following categories:

• Glycemic control.
• Control of risk factors especially important to individuals with diabetes (e.g., obesity, hyperlipidemia, hypertension).
• Health events (e.g., hospitalization related to diabetes).

Policy Considerations Guiding the Current Technology Assessment

To make the current technology assessment relevant to the decision needs of the CMS regional medical directors, three policy considerations guided the review process.

First, interventions currently covered by CMS under preexisting codes are not included in this assessment. Most salient are:

• Diabetes self-management training.
• Medical nutrition therapy.
• Institutional and home care education programs already covered for home health agencies, skilled nursing facilities, hospitals, and outpatient physical therapy providers.
• Behavioral therapies provided for individuals with related psychiatric diagnoses.

Second, while behavioral therapies may be deemed generally reimbursable, it is potentially valuable to regional carriers to specify the conditions under which reimbursement will be provided, based on considerations such as patient, provider, and therapy characteristics. Thus, in this assessment, we sought to identify the circumstances in which behavioral therapies might be especially effective or not. Examples of potentially relevant patient characteristics are age, comorbid conditions, and previous or concurrent therapies. Provider characteristics could include education/licensure and training in the specific behavioral intervention. Therapy could be characterized by type and intensity. As potential guides to targeted reimbursement, we also considered behavioral outcomes in addition to health outcomes.

Third, an evidence-based reimbursement strategy is most useful if the evidence is scientifically credible. Given the real and perceived potential for bias in studies of behavioral therapies, this technology assessment is restricted to assessing randomized controlled trials.

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