Why Medicare cannot promulgate a national coverage rule: a case of regula mortis.

For over twenty-five years, Medicare has tried to promulgate a rule to implement the broad congressional directive to pay only for items and services that are "reasonable and necessary." A rule would clarify legal authority and describe specific criteria for evaluation of new technology in Medicare. This case study is an intractable example of a larger issue of regula mortis or dead rule. Regula mortis occurs when a mobilized interest group blocks legitimate administrative agency action, causing a regulatory stalemate. In this case, the medical device industry has prevented the implementation of a rule. The article diagnoses the condition of regula mortis, explains its effects in the Medicare case, and draws on principles of administrative law to propose remedies to break the logjam. While the case of coverage criteria is important in its own right, it has wider relevance. All health systems must grapple with the challenge of evaluating new technologies. Medicare efforts provide a starting point for the policy discussion. In our current political environment, regula mortis may be an increasingly common phenomenon and the proposed cures for it broadly applicable.