Minnesota Practice Guidelines Legislation

Clinical Practice Guidelines in the Courts
U.S. courts have only just begun to figure out how to deal with clinical practice guidelines (CPGs). To date, most of the litigation about CPGs has involved claims of medical malpractice. Going forward, it is likely that CPGs will also figure prominently in suits involving coverage decisions made under health plans. The relatively few courts that have dealt with CPGs have varied widely in their treatment as evidence. In some instances, CPGs have simply been deemed inadmissible.

For example, a 1995 Maryland statute enacted to encourage guidelines development provided that CPGs developed under the program it established could not be used in litigation (Md. Code Ann. [Health-Gen.] Section 19-606), a restriction that has since been removed from the legislation. In future cases, pursuant to state legislation fostering CPG development and use, some courts will admit them only for use by the defense. Even where they can be introduced by both parties to a litigation, there is a range of alternatives as to how much weight they will be given. Certainly, it will be some time before there are settled conventions for the use of CPGs and for instructing juries on the matter.

If a CPG were to be adopted as the legal standard, questions remain as to how that standard would be applied. Regarding the weight to be given to it, the most extreme approach would be to treat it as a per se standard. In other words, it would be conclusively, or irrebuttably, presumed that the physician was negligent if she or he didn't follow the standard and, conversely, that the care was reasonable if she or he did follow it. This is essentially the approach specified in Minnesota's practice guidelines legislation, discussed below (Minnesota Statutes, Section 62J.34[3], [1992]). A less prescriptive approach would be to treat compliance with a relevant guideline as raising a rebuttable presumption that the physician acted correctly; similarly, noncompliance would raise a rebuttable presumption that the physician acted negligently.

Whichever party asserted the guideline, the opposing party could attempt to counter this presumption by appropriate evidence. This was the approach contemplated in the Health Equity and Access Reform Today (HEART) bill, proposed by Senator John Chafee (R-R.I.) and others in 1993. (S. 1770, 4025, 103d Cong., 1st sess.). Under HEART, adherence to state-developed guidelines which had been certified by the secretary of Health and Human Services would raise a rebuttable presumption of appropriate care that would be overcome only by "clear and convincing evidence," a stricter than normal evidentiary standard favoring the party complying with the guideline. The Chafee bill is significant here because, in the part just discussed, it bears a close resemblance to the proposal put forward below for a CPG certification program.

Some other states, notably Minnesota, have followed Maine's lead by adopting laws providing for only defensive use of practice guidelines (Minnesota Statutes, Section 62J.34[3][a] [1992]). This was also the approach of the Clinton administration's ill-fated Health Security Act proposal (H.R. 4469, 103d Cong., 2d sess., 1994: 441) and several other federal health care reform initiatives of the mid-1990s. Florida initiated a guidelines demonstration project in 1996, roughly similar to that of Maine but limited to cesarean deliveries, the most common surgical procedure in Florida hospitals (Florida Statutes, Section 408.02[9]). The Florida legislation contemplates use of guidelines as a liability shield, although it doesn't expressly limit their use to the defense.