Disease management contracting: legal issues

The legal issues surrounding disease management (DM) agreements can be complex and confusing to participants whose primary expertise is in the management or providing of health care. Because DM is such a rapidly evolving field, attorneys can provide invaluable guidance in avoiding legal pitfalls that can arise from the partners' sometimes-differing goals and expectations. Although managed-care organizations (MCOs) are generally already familiar with the legal issues in DM, the independent partners in DM agreements, often drug companies, may be less familiar with the various state and federal licensing and regulatory requirements that may apply to their DM activities. For this reason, it is important that, unless they are prepared to take on the responsibilities involved with licensing and regulation, independent partners of MCOs should contractually state that they are not "health care providers" and should not engage in activities that would make them subject to regulation. In addition, partnership contracts must be carefully defined to avoid running afoul of federal and state anti-kickback laws, which prohibit certain impermissible inducements to purchase health care products or services covered by Medicare/Medicaid.