Law and Disorder: Critical Legal Issues in Disease Management
James M. Jacobson
James M. Jorling
Neela A. Paykel
If the disease management industry succeeds in producing effective solutions to many of the problems besetting today's healthcare delivery systems (such as misalignment of financial and care incentives, poor customer service, failure to provide useful preventative care, and a dearth of empirical evidence of efficacy and efficiency), it may soon be a multi-billion dollar industry, with the potential for exponential future growth. Yet the law of disease management in the US has not kept pace with the rapid evolution of the industry. Federal and state regulators often mistakingly treat disease management enterprises as if they were healthcare providers or managed-care organisations. These misplaced legal paradigms do not provide adequate certainty and protection for all of the burgeoning companies that wish to comply with the laws yet still remain competitive. This uncertainty has raised nettlesome compliance problems, heightened legal liability, and, increasingly, even threatened disease management product and company viability. In diverse areas of the law - including licensure, telemedicine, liability and compliance, risk-sharing, fraud and abuse, physician incentives and medical record confidentiality - the absence of specific guidance has prompted government officials to take multiple, often conflicting approaches to regulating disease management companies and internal programmes. So far, companies have had to choose from two equally inefficacious remedies for this legal disorder: forego innovation to avoid `legal risk,' or accepts serious legal exposure to avoid `business risk'. Until payors, contractors, and providers advocate - and regulators and legislators promulgate - specific, objective, and appropriate legal and regulatory rules, disease management will continue to face an environment of increasing legal and competitive uncertainty.
Disease management programmes, Health policy, Pharmacoeconomics, Quality of care, Regulatory process, Reimbursement
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