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.


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. 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.

I have written before, briefly, on the redux edition of The Fairness in Nursing Home Arbitration Act.  It is an unnecessary, unwieldy piece of legistlation that 1) tries to solve a problem that is not really a problem; 2) does so in such a way that is both at the same time damaging to residents’ financial interests and de-limiting of the protectioncs already in place; as well as 3) adds expense without value to the end consumer.  

Attorney T. Andrew Graham has commented on this blog before w/r/t these issues, and has both command and clarity in discussing Arbitration in Nursing Home contracts.  So, I wanted to point to an excellent column he has written for McKnight’s.  Its longish, but summarizes the political, legistlative and judicial aspects of The Fairness in Nursing Home Arbitration Act of 2009 (S. 512) very, very well.  

Hopefully, this legislation will be defeated, as it was last term when it was brought before Congress, but I would highly recommend familarizing oneself with the arguments by reading Attorney Graham’s piece.

April 3, 2009

Life Services Network of Illinois has recently sent its members this spot of good news:

The Illinois Senate voted 58-0 and the House voted 115-1 on Thursday to approve House Bill 210, an appropriations bill that includes $678 million to significantly reduce the state’s Medicaid backlog.  

Of course, everyone here in Illinois is very excited by this prospect.  One requirement for receiving money from the Federal Stimulus Package (some 2.9B for Medicaid alone) is a pay-down of debts outstanding.  The backlog must be significantly reduced, in actual ledger, by June 1, 2009. 

The bill now goes to the governor for signing.





Regarding the tragic shooting deaths of 11 people in a North Carolina nursing home on Sunday, March 29th, there is little that can be said.  

We offer our grief.  And, our prayers.  

We are in the business of solace and healing.  Let us hope the families of the victims will find both.

The Secret of NIMS

March 28, 2009

This past week I attended the Life Services Network annual meeting in Chicago.  Honestly, it was a great conference, and many of the things I learned, whether in the sessions themselves or the hallways, receptions, drinks with colleagues, etc., will likely find there way, in one form or another, into this blog.  One notion that particularly caught my attention was an idea that has apparently been coming down the pike for quite some time, but with the stimulus money, finally might have the chance for real government backing and implementation.  In its simplest terms, state departments of public health are considering including nursing homes in regional emergency response teams, much like hospitals are now. 

What interested me about this development is really two things: 1) I know many of my colleagues, especially those that work in skilled nursing facilities, already work hand in glove with their local emergency management agencies.  So, of course, I was left to wonder what shape this involvement would take.  And 2) the plan to include nursing homes in a fundamental way into the emergency response plans will require training in the government’s emergency response system, the  National Incident Management System or NIMS.

The official handbook to NIMS describes its origin and usefulness in this way (link here): Since the September 11, 2001, attacks on the World Trade Center and the Pentagon, much has been done to improve prevention, preparedness, response, recovery, and mitigation capabilities and coordination processes across the country. A comprehensive national approach to incident management, applicable at all jurisdictional levels and across functional disciplines, would further improve the effectiveness of emergency response providers1 and incident management organizations across a full spectrum of potential incidents and hazard scenarios. Such an approach would also improve coordination and cooperation between public and private entities in a variety of domestic incident management activities.

The actual training in the NIMS system consists of some on-line, work at your own pace training with some short term (one hour) classroom training, and, at higher levels, or for executive management, full day, multi-day training.  Although, NHAs, as a profession, suffer from an ever expanding job description, I think it is a good idea to include nursing homes into the emergency response mix.  The simple fact is that aside from hospitals (and in someways superior to hospitals), nursing homes are the go-to infrastructural asset in the face of a large emergency.  No other type of facility has the concentration of health care technology, personnel and space to serve the public in time of great need.  Therefore, I like the idea that may be coming to a state near you; NHAs trained in the decision making process the government has created, assisting their communities through the careful application of their expansive expertise.