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.

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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.

 

 

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.

Representative Linda Sanchez (D-CA) has reintroduced the Fairness in Nursing Home Arbitration Act.  This act seeks to ban pre-dispute arbitration agreements, even if the arbitration agreement is not required for admission. The parties could agree to arbitration only after a dispute arises.   When the bill was last introduced, and defeated, it included Assisted Living facilities as well as Skilled Nursing Facilities, but the text of the bill’s most recent iteration is not yet available for public review.  

Arbitration agreements have been circling back again and again as one of the most contentious debates in LTC Administration.  From a legal standpoint, arbitration almost assuredly means faster recovery time, and less cost for both plaintiff’s and defendants alike (or complaintents and answerers in the parlance of some Alternative Dispute Resolution folks).

 The at bottom question can be phrased like this: is LTC different from other business such that the only pathway to remedy must necessarily be one through the courts?  

Opinions are myriad, but I will be interested to see, and write about, the debate on Rep. Sanchez’ bill.

Over the past few months chatter about filial responsibility laws has been popping up on various blogs and in not just a few law journal note/commentary topics.  See the New Old Age’s thoughts here, and a medium-good law journal note (in preview unless you have  a subscription) here.  

Illinois is one of the 20 states that do not have any kind of filial responsibility law on its books.  Though it is nearly impossible to say this with any certainty, I would be surprised if more than a handful of the 30 states that do have such laws in place actually enforce them / have many lawsuits under them.  However, there is some talk in the Land of Lincoln for revisiting these traditional laws as a way of shoring up faltering Medicaid dollars.  [Of course, the economic stimulus package has quieted much of this talk, with the increase in FMAP and expedited payment structure].  I’ve had at least two conversations with family members at my facility about these laws and what they might mean for adult children of parents with modest savings.  

Because of the increased interest in such laws (either enforcing them or writing new ones) I wanted to briefly define such laws in the general case, and make a very specific point:

General Definition: Filial responsibility laws make adult children legally responsible for their parents’ financial support, including payment for their parents’ basic needs (food, shelter, clothing) as well as medical care (read here: nursing homes).  

Specific Point: Filial responsibility laws vary widely from state to state, as does the method and frequency of their enforcement.  This variance can range from simple fines for non-support, to civil remedies leveraged against children for not obeying the filial responsibility laws.  The point, as with most legal topics, is to look into the specific details of the state proposing/enforcing such laws.  

I won’t touch the subject of whether such laws, in any form, are a good idea or a bad one, but it is worth acknowledging that the pressure for Medicaid dollars is dangerously high, and having some children pay for some parental support is an often talked-about release valve.  

On a personal note, I’ve let the NHA Blog lie dormant for the past few weeks as I ramped up my studying to take the Bar exam in another jurisdiction.  (each Bar exam is state specific – – passing it in one is will not license her/him in another)  But, I took it yesterday and can now get back to writing/thinking about topics of my own choosing.

Off-label use and Medicare

January 27, 2009

The New York Times released another salvo in the debate over off-label prescription drug use and Medicare payments today.  Its article (available here) discusses a rule change that took effect this past November, opening the so-called “compendium pipeline” for Medicare covered drugs that are used off-label to treat cancer.  The article scants on the issue of costs and focuses primarily on the hoary, ‘actual effectiveness versus patient hope’ debate of off-label use drugs.  I would like to look at the cost effect, but before I head down that rabbit-hole, a brief background may be in order.

Off-Label Use Background

Prescription drugs are approved for specific uses, dosages and combinations by the Food and Drug Administration.  The approval process can have multiple steps, independent verifications of trials, and take anywhere from a long time to a very long time depending on the nature of the drug-use seeking approval and the number of researchers providing data. Physicians and other prescribers are free to issue prescriptions for uses outside of those the FDA specifically approves, and do, mostly to very good effect for the patients involved.  Indeed, the cost and time involved prevent many legitimate uses from gaining FDA approval, so the off-label use mechanism acts as a kind of release valve for the strictures of the FDA approval process.

Medicare and private insurance companies are not always willing to pay for these off-label uses, especially if they are experimental.  Since the mid 1980s, however, CMS has authorized payment for off-label treatments so long as they exist in the compendium pipeline – – off-label uses described in collected reference guides which are put together by independent, private non-profits that compile drug research in the medical literature.  So, if an off-label use is described in one of these compendiums (all things being equal – – and there are complicating factors), Medicare will pay for it.  

Cost Analysis

What the New York Times was reporting on was a change in CMS policy that effectively increased the number of compendiums Medicare would look to for approved (i.e. paid for) off-label uses.  Because of the not-for-profit nature of the groups writing these reference guides, the number had dwindled down to only one in 2007.  The new rule increases that to (probably) five, once CMS approves the compendiums seeking inclusion.

What does this mean in terms of the cost of Medicare?  It is going to climb, and maybe drastically.  Many drugs are approved for only one or two uses.  The demand for them, therefore, is lower than drugs approved for multiple uses (or with multiple therapies).  Opening up the compendium pipeline will see more prescribing off-label for uses that are not as well-proven to work as approved uses.  

Of course, this effect will probably be ameliorated by private insurance companies following suit and agreeing to pay for the same uses that Medicare pays for (thus increasing off-label use and driving down cost), but the issue is not without controversy.  

In terms of the law, I see a potential dispute arising from CMS’s action here.  Medicare is essentially obliged to pay for an off-label use if a compendium lists it  unless one of the other guides specifically advises against it.  Medicare recipients are allowed to challenge CMS actions (including decisions to pay or not pay) through the administrative adjudication.  If an off-label use is disputed by two approved compendiums, a Medicare recipient seeking to have that use paid for has standing to bring such an adjudication.

Democratic House leadership announced this past Thursday that the proposed $850 billion economic stimulus plan includes a $90 billion shot in the arm to states by way of a temporary increase to the Federal Medical Assistance Percentage, as well as a few bundled programs, the most notable of which is $20 billion to hospitals and physicians to jump start EMR programs.  

Generally, the proposed stimulus package has come under not inconsiderable scrutiny because of a perceived lack of oversight in how the dollars will be spent.  However, many critics see this as a backlash from the complete lack of oversight when the first half of the so-called “financial system bail out” was delivered.  At any rate, the Medicaid component of the new stimulus plan is not immune to critics who wonder aloud whether the taxpayers will be getting the most bang for these billions of bucks.  

For example, McKnight’s reports that civil rights groups are particularly concerned about tying EMR adoption to these funds, without setting up a privacy assurance protocol/oversight committee.  What has not been mentioned is the connection between this money and the Deficit Reduction Act (discussed, obliquely, here) and whether the DRA programs may be a “shovel ready” protocol that could watch-dog the delivery of this money.