Psychotic Reaction: Off-Label Use Of Antipsychotics In Nursing Homes Costs Medicare
19 CommentsBy Ed Silverman // May 9th, 2011 // 4:25 pm
The unnecessary use of antipsychotics in nursing homes has been controversial for several years. Now, a report from the US Department of Health & Human Services Office of Inspector General finds that, in the six-month period from January through June 2007, 51 percent of Medicare claims for atypical antipsychotics were erroneous. This amounted to a $116 million series of mistakes.
The OIG report was generated at the request of US Senator Chuck Grassley, who expressed concern that atypical antipsychotics - the newest generation of such meds - were being prescribed on an off-label basis, given that the side effects associated with the drugs include increased risk of death in elderly persons with dementia.
Nursing homes are a big business for these drugs. But as the OIG notes, Medicare requires drugs be prescribed for “medically accepted indications” for reimbursement and the Centers for Medicare & Medicaid Services set standards to ensure drugs are not prescribed unnecessarily to nursing home residents.
“Despite the fact that it is potentially lethal to prescribe antipsychotics to patients with dementia, there’s ample evidence that some drug companies aggressively marketed their products towards such populations, putting profits before safety,” HHS OIG Daniel Levinson wrote in a statement. “Government, taxpayers, nursing home residents, as well as their families and caregivers should be outraged - and seek solutions.”
Several states have sued several drugmakers for improper marketing that cost state Medicaid programs money (see here). And Johnson & Johnson is fighting a whistleblower lawsuit, which was joined by the US government, that kickbacks - in the form of rebates and educational grants - were paid to the Omnicare nursing home pharmacy so its Risperdal antipsychotic would be prescribed more often (read this).
So what did the OIG find? Well, 14 percent of elderly nursing home residents had Medicare claims for atypical antipsychotics. Of 2.1 million residents, 304,983 had at least one Medicare claim for an atypical antipsychotic during the six-month period in 2007. Moreover, claims for these residents accounted for 20 percent of the total 8.5 million claims for atypical antipsychotic for all Medicare beneficiaries during the review period. How much money are we talking? Claims for the residents totaled $309 million.
Meanwhile, 83 percent of Medicare claims for atypical antipsychotics for these residents were associated with off-label use; 88 percent were associated with the condition specified in the FDA boxed warning. Using medical reviewer responses, the OIG determined that almost 1.4 million atypical antipsychotic claims were for elderly nursing home residents diagnosed with conditions that were off-label and/or specified in the boxed warning.
Also, 51 percent of Medicare atypical antipsychotic drug claims for elderly nursing home residents were erroneous, amounting to $116 million. For that six-month period in 2007, the OIG reviewed medical records and found more 726,000 of the 1.4 million atypical antipsychotic claims for these residents did not comply with Medicare reimbursement criteria. “The drugs were either not used for medically accepted indications as supported by the compendia or not documented as having been administered to the elderly nursing home residents,” the OIG writes in its report.
Finally, 22 percent of the drug claims were not administered in accordance with CMS standards regarding unnecessary drug use in nursing homes. For the six-month period, OIG reviewed medical records and found that 317,971 Medicare claims worth $63 million were associated with atypical antipsychotics that were not administered according to CMS standards for regimens in nursing homes.
As an aside, the OIG notes that nursing home noncompliance with CMS standards - such as providing excessive doses or for excessive durations - does not cause Medicare payments for the drugs to be erroneous, because payments are made on behalf of residents, not nursing homes. However, the OIG points out that failure to comply with standards may affect nursing home participation in Medicare.
The OIG made a handful of recommendations, including facilitate access to info needed to ensure accurate coverage and reimbursement determinations; assess whether survey and certification processes offer adequate safeguards against unnecessary antipsychotic drug use in nursing homes; explore alternative methods beyond survey and certification processes to promote compliance with federal standards concerning unnecessary drug use in nursing homes, and taking appropriate action regarding claims associated with erroneous payments identified in the OIG sample.
In response, CMS agreed with the second, third, and fourth recommendations, but not the first one and expressed several concerns with the report overall. In regards to the first recommendation, CMS argued that stating diagnosis info is not required of pharmacy billing transactions or generally included on prescriptions. But the OIG maintains that, without access to diagnosis information, CMS cannot determine indications for which drugs were used. For this reason, CMS is unable, absent a medical review, to determine whether claims meet payment requirements.
Duane Sherry, M.S.
Psychiatric drugs are not safe for people who are elderly -
http://www.ahrp.org/cms/index.php?searchword=elderly&option=com_search&Itemid=5
Thank you for posting.
Duane Sherry, M.S.
http://discoverandrecover.wordpress.com
M. D
Many elderly nursing home residents are prone to violence and not safe for the other residents. There are no approved drugs for this situation.
industry insider
I profoundly disagree. Most elderly nursing home residents lack the ability to be violent, and the occasional disrupter certainly doesn’t merit the blanket prescription of nightly antipsychotics, such as “five at five”, ie. the off label regimen promoted by Lilly where every resident receives 5 mg of Zyprexa at 5PM in order to keep them sedated in the evening and not interrupt the staff poker game. Absolutely criminal practice.
Don’t trust my word. Go to the Medicare web site and just stay with the 4 or 5 star places if you are looking to place a loved one.
http://www.medicare.gov/NHCompare/Include/DataSection/Questions/SearchCriteriaNEW.asp?version=default&browser=Firefox|3|Windows+Vista&language=English&defaultstatus=0&pagelist=Home&CookiesEnabledStatus=True
Duane Sherry, M.S.
M.D.,
You think antipsychotics (neuroleptics) are okay?
You first! -
http://discoverandrecover.wordpress.com/warning/
Passionately,
Duane Sherry, M.S.
Duane Sherry, M.S.
M.D.,
If you don’t have time to scroll through the links on the above-reference page, at least read this -
http://www.madinamerica.com/madinamerica.com/Timeline.html
The American people are waking up, and many of us are saying, “ENOUGH!”
Duane
MsPiggy
How many of these elderly patients are dying prematurely from complications directly linked to the neuroleptic drugs being forced upon them as behavioral controls?
Who is investigating this matter? Surely it’s not the medical boards overseeing these doctors, or the nursing home regulators, or any law enforcement entities…
It appears all the government & DOJ want is money from the illegal billings. This is way beyond shameful, it’s a total disgrace heaped upon America and it’s citizens…
They are not only are neuroleptics not approved for use in this population, they have a black box warning against their use.
This issue goes much further than unethical off label prescribing; this is criminal nursing home abuse that should be prosecuted to the fullest extent of the law; not just a medicare fraud recovery gloss over that makes a headline & pacifies journalist..
AA
MD,
As one who worked with special ed students, I was attacked occasionally. But personally, I would have been opposed to them being put on anti psychotics. I felt it important that a serious attempt be made to figure out the underlying reasons for the problems.
Interestingly, in one case, it was an issue of a student who got overwhelmed by loud noises. Moving the person to a quiet environment cut down on the attacks considerably.
In my opinion, that is the same attitude that needs to be taken with nursing home residents. By the way, I think you are totally off base in implying that many nursing home residents are violent.I
Here is a link to information about behavioral interventions reducing the need for medications.
http://www.pennsylvanianursinghomeabuseattorneyblog.com/2011/02/pilot-project-finds-behavioral.html
Yes, it takes some work to figure out what works. But isn’t your profession’s motto, “first, do no harm?” Throwing meds at a problem in which deadly side effects result without first trying non med solutions grossly violates that creed.
Part D administrator
CMS significantly limits Part D and Medicare Advantage plans in terms of how we are allowed to manage this class of drugs. They are a protected class and essentially hands-off. The problem of inappropriate utilization is widely known. The protected nature of these drugs is a key contributor. If given the green light, Part D administrators could virtually eliminate this problem very quickly.
Bobby
Reminds me of the story of the nursing home in Los Angeles, in which the Nursing Director gave big batches of these wicked drugs to residents she “didn’t like”. A number died, and she, the Medical Director, and Pharmacist were arrested.
As we know, however, individual pharmaceutical company personnel who have been pushing things like “5 at 5″ are NOT being arrested, despite the criminal nature of their acts. Their companies are just paying huge fines to the U.S. Justice Department.
It’s time more people spoke out, including the family members of nursing home residents who hopefully will learn the truth of why some of their loved ones have died.
This class of drugs is really good for nothing except large profits to stockholders and large salaries to CEOs.
Justice in MI
Coming in late, but Gardiner Harris’s piece in the NYT on this was also interesting. The IOG report described the off-label promotion of the AAs for elderly pts as having “lethal” (IOG’s word) consequences.
industry insider
Bobby, I once knew a cold sadistic, passive- aggressive tyrant of a nurse similar to whom you describe. Her name was Mildred Ratched.
http://www.imdb.com/title/tt0073486/
FDAer
This is no surprise. We at FDA know that when we put a black box warning on something it may only drop sales by 10% initially and then they will usually come back.
FDA knew about the lethality of antipsychotics in the elderly as far back as 1996. Yet of course there was no warnings in the labeling to prevent misuse and off-label prescribing. Meanwhile winking at the company and letting off-lable promotion occur.
That’s another way this is done. ‘We can’t regulate (alter) the practice of medicine.’ Yet isn’t that what FDA is doing when it promotes antipsychotics for children in the labeling of ADHD meds, when it recommends evaluation for bipolar disorder when a kid displays “irritability”. In fact the FDA advisory committee hearing and push to claim that ADHD meds reveal bipolar illness was based on redefining reports of irritability as psychosis.
Having been a whistleblower to Grassley and provided his staff with information on corruption within the FDA including criminal activity and insider trading in the FDA psychiatry division. I know that there’s a lot more going on and it will simply be business as usual until FDA officials go to prison (yes there are documents with blatant evidence) and they actually try to protect the public as they’re supposed to instead of waiting until there’s a public outcry when the train has already left the station. (Dave Graham used to say to me that he came to the site of train wrecks but that I saw them coming.)
Just wait. I know that Tom Laughren the psychiatry division director has been knowingly overdosing kids. That along with all the overuse (1% of all kids, with most being below 12 years old) we will likely be having a major crisis down the road.
Of course every one will say but we couldn’t have known. Just like people couldn’t have known with Bernie Madoff. At least he wasn’t mass poisoning children.
Think the usage in the elderly is expensive. Just wait. The usage in kids and especially treating their side effects (tardive dyskinesia, cardiac problems, gynecomastia, liver failure) has the potential to cost us a lot more, especially if they wind up on a public health plan of some type, because they’re too disabled to work because of the drugs.
Just call me Harry Markopolis, Jr.
Been There
I have to agree with “FDAer.” The companies that market ADHD drugs have been ruthlessly brilliant at creating the initial market and now additional indications, essentially driving a need for sales without the medical necessity. What fraction of the population does not show irritability, lack of focus at times, etc. But as the marketing numbers show that the pediatric, adolescent, and adult markets are saturated with ADHD sales and the only remaining slice to grow sales is the young adults (i.e. college students) then these companies are being more aggressive in creating new demand where a medical necessity does not exist. And the companion effort are promotional campaigns to exort “compliance.” What this really means is that if a prescription holder only takes a dose every once in a while, then the company cannot fill as many refills and loses money. This is placed in the context of “caring” for the patient but is in fact a revenue issue for lost doses. Some of these companies are under investigation by HHS OIG and there is a strong likelihood that at least civil fines and corporate integrity agreements will be levied. But I’m afraid that is a small price for these comapnies - they factor this in as a cost of doing business and keep on trucking. Physicians can and have practiced medicine without the meddling of the pharma industry - only significant reform on the medical practice side will force companies to change marketing tactics.
Bobby
FDAer, you state what I suspected and have concluded - having been an innocent citizen testifying numerous times before FDA advisory committees against psyc. drugs. The body language alone gives away the secrets held by the officials in charge.
As for the train wreck that is coming due to use of psyc. drugs, it is eloquently spelled out in Robert Whitaker’s brilliant book, “Anatomy of An Epidemic”. Let us only hope and pray that the Congress and Administration wake up. Today wouldn’t be soon enough.
Justice in MI
One of the “interesting” facets of the AA sagas is that even when companies have been busted–e.g., Lilly for $1.4B re: Zyprexa–sales of the relevant drug have been barely affected.
Lessons learned:
1. Really was a good drug for all those uses, despite absent science.
2. Crime pays.
3. Docs are as vulnerable to habit-forming “drug dependence” as everyone else.
In this particular case, we should also not forget the role of nursing homes in finding a cheap way to make those troublesome old folks shut up and die soon.
You choose.
Duane Sherry, M.S.
Industry insider,
Wow.
What a great movie that was… ‘One Flew Over the Cuckoo’s Nest’!
I was reading your comment, wondering what you were going to say, and you ended with ‘Nurse Ratched’
The movie kinda says it all… and those wards haven’t really changed a bit, other than they are using more powerful drugs than ever before!
My best,
Duane
Gassa
The old folks are in the nursing homes to start with because their families don’t want them in their homes. That’s the real tragedy here — people kick grandma to the curb.
Look in the mirror, folks. Look in the mirror. It’s not pharma, it’s not psychiatrists, it’s you. How many of you want your old folks in your house?
industry insider
Duane, like Jack Nicholson said in Cuckoo’s Nest, “A little dab’ll do ya”. Best line from Jack next to “Here’s Johnny!”. I’m sure you remember that movie.
Duane Sherry
industry insider,
Oh Wow,
What great lines!
A couple more -
“Which one of you nuts has any guts?”
- One Flew Over the Cuckoo’s Next
And one more appropriate to this post…
Re: The myth of pscyhopharmacology
“You can’t handle the truth!”
- A Few Good Men
Thanks for the memories of some great movies!
My best,
Duane