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.

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.

 

 

 

 

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.

It turns out the main stream media has somehow received the Five Star data ahead of many nursing homes. The listserves are abuzz with Administrators complaining of having to talk to newspapers, televisions stations and the like about their five-star rating, without actually knowing the rating themselves.

Furthermore, there seems to be a lot of grumbling about the accuracy and precision of the Five Star Ratings. The five step “How the Ratings are Calculated” guide CMS sent to MDS mailboxes is pretty basic. In case you haven’t seen it, here it is:

How the Ratings are Calculated:

A nursing home’s Overall Quality rating on Nursing Home Compare (www.medicare.gov) is based on its ratings for Health Inspections, Quality Measures (QMs), and Staffing. Ratings for each domain and the overall rating range from 1 star to 5 stars, with more stars indicating higher quality. Based on these three ratings, the overall 5-star rating is assigned in 5 steps:

Step 1: Start with the Health Inspection Rating.

Step 2: Add one star if the Staffing rating is 4 or 5 stars and also greater than the Health Inspection rating. Subtract one star if the Staffing rating is 1 star. The rating cannot go above 5 stars or lower than 1 star.

Step 3: Add one star if the Quality Measure rating is 5 stars; subtract one star if the Quality Measure rating is 1 star. The rating cannot go above 5 stars or lower than 1 star.

Step 4: If the Health Inspection rating is 1 star, then the Overall Quality rating cannot be upgraded by more than one star based on the Staffing and Quality Measure ratings.

Step 5: If a nursing home is a Special Focus Facility that has not graduated, the maximum Overall Quality rating is 3 stars.

Nursing Home Compare provides a five-star rating for each of the following three components:

1) Health Inspection ratings:

• Ratings are calculated from points that are assigned to the results of nursing home surveys over the past three years, as well as complaint surveys from the past three years and survey revisits. More recent surveys are weighted more heavily.

• Points are assigned based on the number, scope and severity of a nursing home’s health deficiencies. If multiple revisits are required to ensure that major deficiencies are corrected, additional points are added to the health inspection score.

• Lower health inspection scores result in a better 5-Star rating on Nursing Home Compare.

• Nursing homes are ranked within their state based on their score, and the number of stars is based on where the nursing home falls within the state ranking.

• The top 10% of facilities get 5 stars, the bottom 20% get 1 star, and the middle 70% of nursing homes receive 2, 3 or 4 stars, with equal proportions (23.33%) in each category.

• Health Inspection ratings are re-calculated every month to account for new survey results entering into the system.

2) Quality Measure ratings:

• Ratings are calculated from a nursing home’s performance on 10 Quality Measures (QMs), which are a subset of those reported on Nursing Home Compare.

• The QMs include 7 long-stay (chronic care) QMs and 3 short-stay (post-acute care) QMs.

Long-Stay QMs Short-Stay QMs

• ADL Decline

• Mobility Decline

• Catheter

• High-Risk Pressure Ulcers • Physical Restraints

• Urinary Tract Infections

• Moderate to Severe Pain • Pressure Ulcers

• Moderate to Severe Pain

• Pressure Ulcers

• Ratings are calculated using the three most recent quarters of data.

• ADL Decline and Mobility Decline contribute more heavily (each weighted at 1.667 times) than the other QMs.

• A nursing home’s performance on the ADL Decline and Mobility Decline QMs is ranked against all other nursing homes in the state.

• A nursing home’s performance on the other 8 measures is ranked against all other nursing homes in the nation.

• Points are assigned for each QM based on what quintile the facility falls in comparison to other nursing homes. Points for each QM are added together for a total point score.

• Based on this total score, the top 10% of facilities nationwide get 5 stars, the bottom 20% get 1 star, and the middle 70% of nursing homes receive 2, 3 or 4 stars, with an equal proportion (23.33%) in each category.

3) Staffing ratings:

• Ratings are calculated from two measures: RN hours per resident day and total staffing hours (RN, LPN, nurse aide) per resident day. These two measures contribute equally to the Staffing Rating.

• Staffing measures are derived from OSCAR data that is then case mix adjusted based on the facility’s distribution of MDS assessments by RUG-III group, based on the number of RN, LPN, and nurse aide minutes associated with each RUG-III group

• Other staff, such as clerical, administrative, and housekeeping staff, are not included in the calculation of the Staffing ratings.

• For each staffing measure, a 5-Star rating is assigned based on where the facility ranks compared to the adjusted staffing hours for all freestanding facilities AND where the facility ranks compared to optimal staffing levels identified in the 2001 CMS Staffing Study.

• To earn 5 stars on the Staffing rating, the nursing home must meet or exceed the CMS staffing study thresholds for both RN and total nursing hours per resident day.

• The Nursing Home Compare website will include a “drill down” that shows the nursing home’s rating for RN Staffing.

The RN Staffing Rating for Nursing Home Name is .

Ratings are provided only for nursing homes that have had at least two standard health inspection surveys. Nursing homes that have not yet had two standard health inspection surveys are listed as ‘too new to rate,’ and no rating information is provided for the nursing home If the rating indicates ‘data not available’ then the data needed to rate the nursing home were not available.

If Your Rating Isn’t What You Think it Should Be

If your nursing home’s rating seems to be markedly different from your expectation, it may be that a recent survey has not yet been entered into the database. It may also arise from a dispute resolution or appeal decision that has not yet entered into the database. You can check the health inspection detail on Nursing Home Compare for more information about the particular deficiencies that entered into the calculation.

If your quality measure rating states “data not available,”, it means that there were too few eligible residents for us to calculate a reliable quality measure. If your staffing score says “data not available,” it means that the number of hours of staffing were found to be a value that were so extremely high or low that they were not plausible. In this case, please check with your state survey agency to confirm the staffing values you reported.

A technical manual containing additional information can be found on the CMS website (http://www.cms.hhs.gov/CertificationandComplianc/).

 

If you have questions, please contact the 5-Star Helpline at 1-800-839-9290.

To make matters worse, as of this writing, the technical manual has not yet been published on CMS’ website (the link above). So, some Administrators are getting some pretty bad news, with no technical context in which to frame it.

Whether the Five Star Nursing Home Compare site will be a highly used tool by the public remains to be seen, but the five star system needs to accurately reflect the quality of care if it is to be a usable metric.  My fear (and I’m sure I’m not alone in this) is that the Five Star system will make a confusing, relatively difficult to use, flawed data set (the Nursing Home Compare website) less difficult to use, but still just as flawed.  I know my own facility’s overall star rating was less than I anticipated.  I intend to pour over the technical manual, looking for a way to match the Nursing Home Compare Five Star Rating with the quality of care I know my staff provides every day.

*Update: the technical manual is now online.  I’ve made the link above live.