U of Chicago “Off-Label” Study and MedMal

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

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.

60,000 AARP members jump ship

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.

Graham’s Fantastic Column on The Fairness in Nursing Home Arbitration Act

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.

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.

 

 

 

 

Tragedy in North Carolina Nursing Home

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

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.

Patient Safety and Abuse Prevention Act of 2009

As reported on McKnights.com, the Patient Safety and Abuse Prevention Act of 2009 (PSAP) was reintroduced to the Senate this week.  The proposed law would expand upon a seven state pilot program that provides funding for nursing homes to conduct Federal Criminal Background checks on all nursing home employees. 

Like many bills introduced in this first Congressional session of the Obama administration, this bill has been around the block a time or two.  In its previous incarnation, the PSAP included a funding provision to conduct federal criminal background checks on potential residents as well as employees, but it appears that provision was dropped to make this new bill more palatable.  This is probably a good “single-subject” modification, as background checks for employees and residents are truly different topics.  And, screening employees with a Federal Criminal background check is too important for the bill to be defeated based on a parallel, but unrelated, analysis. 

To illustrate the point, consider the following from an article in Modern Health Care:

 “Forty-one states require criminal background checks on most aides prior to employment, but only half of those    require criminal background checks at the federal level. In 2004, state agencies reported that they received more than 500,000 reports of elder and vulnerable adult abuse.”

This new version of the PSAP is really a funding bill, more than a mandate.  Essentially, it would open up money, in the form of grants, tying with said money an admonition to conduct checks on all current and future employees, to nursing homes meeting a certain set of criteria (essentially those receiving Medicare money). 

Personally, I am an advocate for this type of bill.  Sure, there is already a huge amount of processin the Long Term Care hiring process.  From CNA databases, state level criminal background checks and some Federal checks, hiring is a costly, and time consuming process.  But, two arguments win out on the other side: 1) Such checks really will keep elders in LTC safe, or at least safer, from criminals moving from one state to another to work in LTC; 2) from a legal liability standpoint, such checks create a prima facie argument that a facility was not negligent in hiring. 

Negligent hiring lawsuits have made hay in the past few years, and not only in health care.  One benefit from so much mandated process in when hiring someone for LTC, is that should the worst happen – – should an employee harm a resident, the facility can insulate itself from the inevitable lawsuit by pointing out that a) the state and federal government require a lot of work from employers before they can hire an employee and b) by doing all of that work, the facility has done everything reasonable within its power to prevent just the sort of harm that has happened.  The failure of this duty is what is at bottom of negligent hiring suits.

So, I welcome the reintroduction of the Patient Safety and Abuse Prevention Act.  Hopefully, this bill will move swiftly through Congress and the president’s desk.   The money from this bill will increase resident safety, and afford LTC providers another shield against the sword of negligence suits.

Nursing Home Compare – Opportunity for Web 2.0?

The working life of a nursing home administrator can be a tough one.  There are innumerable tasks that fill up the days (and nights), and one drawback of the job is that we often suffer under a woefully underdeveloped job description.  In an effort to put out today’s fires, we can miss some pretty important pieces of information that come down the pike.  For example, I only recently got around to reading the AAHSA (American Association of Homes and Services for the Aging) report that came out this past summer, “Broken Beyond Repair: Recommendations to Reform the Survey and Certification System.” 

Life Services Network hosts a permanent link to the full report (here).  If you, like me, have been too busy to read it, I recommend giving it a glance as soon as you can.  Especially with the regulatory change winds blowing as hard as they have been in recent months, it is important for on-the-ground LNHAs to understand the issues involved so we can support the advocacy and lobby groups when they make their arguments.

At any rate, the report contains a number (31) of specific recommendations for improving the current certification and survey process (as well as its overall conclusion of OBRA ’87 needs to be completely revisited, and the surv/cert process overhauled).  One in particular has caught my imagination.  It reads as follows:

 

AAHSA should encourage CMS to revise the Nursing Home Compare Web site so its language is less pejorative and the data it presents is easier to understand and includes a full explanation of survey results. This can be accomplished by giving providers the opportunity to elaborate on the Statement of Deficiencies posted on Nursing Home Compare by adding specific facts related to its cited deficiencies in a standardized format established by CMS.

A major complaint I’ve heard from LNHA colleagues and read in the listserves w/r/t the Five Star Component to Nursing Home Compare is that the website does not offer enough explanation of the results, and that the results do not indicate true quality (i.e. how a resident is actually taken care of – – the compassion factor).  The above recommendation could be an excellent step towards meeting this complaint.

Imagine if you were able to address the deficiency as noted now by a  number of stars in a graph through a short narrative, properly formatted for consistency and ease of use.  I know I would feel better about my facility’s star rating (even though already good) if I could directly address some of the viewer witha  paragraph.  Further, this sort of collaborative back and forth – – adversarial tension between Surveyor and facility – – could result in a dialogue with residents and their family members regarding the appropriateness of the survey results as reported on CMS Nursing Home Compare.  Such a dialogue would help us get to a better regulatory tool (RE: Survey Process), which is the point of OBRA ’87 in the first place.

Indeed, it could go farther than just the facilities having the opportunity to comment on the Survey and Certification results as posted on Nursing Home Compare.  Would it not be empowering to residents and their families if the CMS site allowed them to post their own comments for others to see?  I think it is an idea worth exploring.  If the regulators’ survey results, the facilities’ comments, and the residents and their families’ opinions were collected in the same place, I think the true relative worth and value of a nursing home would out – – rewarding the good and encouraging the bad to improve.  What a lofty, but possible goal.

 

 

Nobody’s Home by Thomas Edward Gass

I am myself a transplant to the long term care industry.  As is clear from many of these posts, and the focus of my arguments, my training is in the law, with a particular emphasis on health law and health care administration.  So, if it is fair to say, I think I am intellectually well-equipped to work as a nursing home administrator, but I have not had the emotional experience in LTC that many of my administrator peers have had.  

To try to bridge this gap, I read the book Nobody’s Home: Candid Reflections of a Nursing Home Aide by Thomas Edward Gass.  Mr. Gass is himself a transplant to the long term care industry.  His training is in psychology, and before becoming a CNA, he was a student of transcendental meditation, traveling widely around the world.  

What I found interesting, and ultimately most useful, about Mr. Gas’ book is his unabashed way of describing his own reaction to the difficulties of LTC.  He goes into detail about how difficult it is to simultaneously be his resident’s caretaker, friend, surrogate child, scold, and advocate.  The nurses’ aide position is one that is, tortuously at times, both heartbreakingly intimate, and necessarily removed.  

From my first day in this industry I have heard tales about an administrator who put herself into the position of the CNAs or the residents for a time in order to more fully understand the operation of her facility.  Likely such stories are apocryphal, but even if they are true, such a strategy is simply impracticable for most of us.  However, Nobody’s Home is a good introduction to such an experience, and I would recommend it to any NHA looking to understand the emotions of our jobs.