by David B. Honig
Federal regulations are an enormous morass of complex, confusing, and often contradictory rules. The 2009 Code of Federal Regulations was 163,333 pages in 226 individual books. The 2010 Federal Register, which contains new regulations proposed rules, and presidential papers, contained an additional 81,305 pages. Intended as a roadmap, providing guideposts and requirements for dealing with the Government, it has become so incomprehensible to the layman that it could just as easily be a 16th century copper globe engraved “HC SVNT DRACONES” (Latin, hic sunt dracones, or “here be dragons”).
It is little wonder that health care providers, bankers, defense contractors, builders, even farmers and ranchers, turn to attorneys to help understand what they are allowed to do and, even more important, what actions are prohibited. A regulatory attorney helps guide a client through the regulatory jungle, identifying the client’s needs and goals and advising how they can be met (and sometimes if they can be met) within the confines of the regulations. This actually confers two different benefits on the client. The first, the obvious benefit, is concrete advice on what the regulations permit and prohibit. The second, less obvious, less ofen needed, but absolutely critical when the need arises, is confidence that the client did the very best it could to comply with all applicable laws, rules, and regulations. If the government ever aggressively challenges the client’s actions, particularly if it challenges the actions in criminal court or in a False Claims Act case, this forms the basis for what is known as the “advice-of-counsel defense.” Advice to the client is always at the forefront of the client’s and counsel’s minds, while the advice-of-counsel defense is rarely, if ever part of the engagement or ongoing conversations. It does, however, form a crucial backstop of protection for the client. Therefore, any attorney providing regulatory advice should have a working understanding of the defense, how it is used, how advice should be provided to protect the defense, and how it can be unintentionally ruined or even waived, perhaps even before the need for the defense is recognized.