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I fought the law...and the law won?

Medical Staff Affairs Monthly, February 13, 2008

In 1968, there was much talk and great concern about the "military-industrial complex." This shadow organization was viewed as an amorphous conspiracy of individuals, groups, and corporations that enriched themselves and/or consolidated power by promoting conflict and war.

In 2008, there is much talk and great concern about what we might call the "legal-regulatory complex." This amorphous entity consists of individuals, groups, and agencies intent on enriching themselves and/or exerting control by putting a stranglehold on the $2 trillion healthcare system. Many medical staff and hospital leaders can relate to Josef K., the protagonist in Franz Kafka's novel, The Trial, when he says,  "There can be no doubt that behind all the actions of this court...there is a great organization at work. An organization which not only employs corrupt warders, oafish Inspectors, and Examining Magistrates.but also has at its disposal a judicial hierarchy of high, indeed of the highest rank, with an indispensable and numerous retinue of servants, clerks, police, and other assistants, perhaps even hangmen."

Today's medical staff and hospital leaders are caught up in a wilderness of mirrors. It consists of complex, conflicting, and contradictory sets of directives, rules, regulations, and standards. Consider the following:

 The Office for Human Research Protections (OHRP) of the U.S. Department of Health and Human Services (HHS) suspends a statewide quality initiative in Michigan to improve critical care services. Michigan's offense? OHRP stated that the use of a checklist in critical care units in Michigan to determine whether they helped reduce infection rates was both unethical and, infact, illegal because patient consent was not obtained and thus, the use of the checklist did not comply with research regulations. The parent agency, HHS, simultaneously begins the MS-DRG program in October 2008, which will eliminate reimbursement for some hospital-acquired infections, particularly in the critical care unit.

 State and national legislatures fall over themselves to pass laws mandating access to services and determining length of stay for certain conditions. Senator Mary Landrieu (D-LA) sponsors legislation to prevent drive-through mastectomies. In Texas, legislation is proposed to transform clinical practice guidelines set forth by the Screening for Heart Attack Prevention and Education (SHAPE) Task Force into a legislative mandate. The state of Minnesota mandates access to bone marrow transplantation, although the evidence base is sketchy at best. The state of New Jersey dictates a minimum length of stay for uncomplicated vaginal delivery. Although  these actions might be driven by compelling personal or political issues, the increasing transformation of clinical guidelines into legislative mandates is of concern, as elaborated by Peter Jacobson's Commentary in the January 9/16, 2008 JAMA issue.

 The American Academy of Neurology (AAN) issues Lyme disease guidelines with a recommendation against administering prolonged courses of antibiotics, noting there is no evidence that such prolonged treatment  reduces the severity of post-Lyme syndrome and that the treatment itself can lead to severe adverse events.  **Edits okay in previous sentence?** After the AAN puts forth this guideline, the Connecticut Attorney General's office  subpoenas the AAN as part of the investigation of the Infectious Disease Society of America's written guidelines. The concern is restraint of trade and anticompetitive behavior because of the potential for denial of medical coverage for medications not recommended by the guidelines.

 CMS reports that Medicare spending jumped 19% in 2006 and total healthcare spending rose 6.7%, to a total of $2.1 trillion. Although these increases in part reflect Part D pharmaceutical cost, it is difficult to carve out the cost of increasing legal and regulatory compliance requirements. In its fall 2007 report, the Healthcare Financial Management Association (HFMA) rated the biggest cost factor affecting US hospitals over the next 3-5 years as accelerating regulatory requirements. This was followed by increases in pharmaceutical spending, investment in productivity tools, and cost reduction due to pay for performance (P4P) programs.

All these challenges require a strong and influential response from well-prepared and effective medical staff and hospital leaders. Medical staffs and hospitals now, more than ever, need to collaborate and put aside the nefarious divisions and infighting that absorb energy better applied to external battles and struggles that affect the whole healthcare community/system. The Greeley Company has long provided practical strategies to many organizations facing these challenges. Let us know if we can be of help.

Until next time, be the best that you can be.

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