As recently reported in McKnights’, the New York Times, and elsewhere, a recent study suggests a significant number of physicians are unaware their prescribing habits are “off-label” for certain drugs.  There is nothing illegal about this.  Many drugs have therapeutic uses that extend well beyond their FDA approved ones.  The FDA does not have the resources to approve every use, especially for drugs which have been proven safe and effective, and are in the use stream or have been for years.  However, depending on medical malpractice standards in the state in which a physician is prescribing drugs, off label prescriptions, especially unknowingly off-label prescriptions, carry with them a significant medical malpractice liability.

Every state is different, but generally physicians will be held to a negligence standard that is compared with their geographic/practice specific peers; that is to say an rural Missouri physician will be expected to perform at the level, and make the same general type of decisions as a similarly situated physician.  She need not perform at the level of the best physician, in the area of the country with the highest concentration of outstanding physicians to be free of negligence (or malpractice), merely at a level in keeping with the generally held standards of physicians in her area, and the profession as a whole.

Off-label prescribing can, and usually does, fit very nicely into this pattern.  In fact, there are many cases where not prescribing under an off-label use could be arguable malpractice.  However, if physicians are assuming “on label” use when prescribing, but are actually not following the approved guidelines for use and effectiveness by the FDA, there exists, then, a strong argument for violation, for malpractice, should an adverse outcome arise out of the unknowingly off-label prescription.

I’ve not explored this topic far enough to cite specific examples, but if the U of Chicago study holds water, then a significant number of physicians are exposing themselves to liability in their prescribing habits.

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Letter, if Not Spirit

August 20, 2009

Skilled Nursing Facility administrators often complain the survey process is too focused on the letter of CMS guidelines, and not the spirit of them.  Nurses grouse that good care is evident despite a lack in documentation; “quality of life” is too subjective for so-called “paperwork deficiencies,” and so on.  Earlier this week an appeals court in Chicago turned the same tables onto the Illinois Department of Public Health.

An SNF appealed a Type A, serious type, violation.  The IDPH fine was $10,000.  The successful argument was not based on the merit of the deficiency tagged, but on the timing of the notice.  The Department failed to notify the facility of the Type A violation within 60 days of the end of the annual survey.  (Notice was actually given on the 66th day, though regulation requires it within 60 for violations of that type)

The facility’s lawyer successfully argued that the Department lost jurisdiction to prosecute a violation because the notice fell outside of the window prescribed by Administrative Rule.

This case highlights an important issue within the current regulatory scheme.  1) Such deadlines are essential if facilities are to learn from their mistakes.  That is, prosecution of violations is not merely punitive, but compels facilities to do better next time.  A deadline lets facilities know that, if there are changes to be made, you’ll be told about them in a reasonable time.  This allows regulatory codes like IDPH’s and CMS’s to have what is known as a “channeling function.”  Sure 66 days may be no more unreasonable than 60 in this respect, but for a deadline to have the necessary channeling function effect, it must have a definite cutoff.  2) The regulatory scheme is necessarily (and some would argue counter-productively) adversarial.  It seems like the facility’s lawyer “gamed the system” or “won on a technicality.”  This argument, incidentally, is the same as when facilities claim to have only received a “paperwork deficiency” or have been “caught without documentation.” At the end of the day, an adversary system creates incentive to “beat” the other side, but it also incentivizes winning on the margins.  That is to say it discourages substantive change (which takes more energy and resources than winning on technicalities).

The ideal would be to marry the channeling function of deadlines and the innovation and energy created by the adversarial system while divorcing this kind of small ball, winning on the margins attitude.  That kind of third way is, alas, tremendously difficult to find.  However, I think cases like this one expose the issues that come along with decisions based on the letter, if not the spirit of the Law – – or in this case, Rule.

*Thanks goes to LSN’s Week’s News newsletter for source material.

McKnights.com reports this morning that some 60,000 AARP members have discontinued their membership since June 1, 2009.  The ostensible reason? Disagreement over AARP’s seeming position in the health care reform debate.  Though AARP has not endorsed any presented plan as of yet, certain statements by its leadership indicate that the largest association representing America’s retired population is more in support of, rather than opposition to, the reform plans on the table.

The article goes on to say that the majority of those leaving the AARP are joining the American Seniors Association.

The AARP has long been one of the most powerful political voices in matters concerning elder care, if for no other reason than it represents huge numbers of active voters.  It is concerning that the health care reform debate is weakening that front.