[Senate Hearing 112-305]
[From the U.S. Government Publishing Office]
S. Hrg. 112-305
OVERPRESCRIBED: THE HUMAN AND TAXPAYERS' COSTS OF ANTIPSYCHOTICS IN
NURSING HOMES
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HEARING
BEFORE THE
SPECIAL COMMITTEE ON AGING
UNITED STATES SENATE
ONE HUNDRED TWELFTH CONGRESS
FIRST SESSION
__________
WASHINGTON, DC
__________
NOVEMBER 30, 2011
__________
Serial No. 112-11
Printed for the use of the Special Committee on Aging
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SPECIAL COMMITTEE ON AGING
HERB KOHL, Wisconsin, Chairman
RON WYDEN, Oregon BOB CORKER, Tennessee
BILL NELSON, Florida SUSAN COLLINS, Maine
BOB CASEY, Pennsylvania ORRIN HATCH, Utah
CLAIRE McCASKILL, Missouri MARK KIRK III, Illnois
SHELDON WHITEHOUSE, Rhode Island DEAN HELLER, Nevada
MARK UDALL, Colorado JERRY MORAN, Kansas
MICHAEL BENNET, Colorado RONALD H. JOHNSON, Wisconsin
KRISTEN GILLIBRAND, New York RICHARD SHELBY, Alabama
JOE MANCHIN III, West Virginia LINDSEY GRAHAM, South Carolina
RICHARD BLUMENTHAL, Connecticut SAXBY CHAMBLISS, Georgia
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Debra Whitman, Majority Staff Director
Michael Bassett, Ranking Member Staff Director
CONTENTS
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Page
Opening Statement of Senator Kohl................................ 1
PANEL OF WITNESSES
Statement of Daniel R. Levinson, Inspector General, U.S.
Department of Health and Human Services........................ 2
Statement of Patrick Conway, Director and Chief Medical Officer,
Centers for Medicare and Medicaid Services, U.S. Department of
Health and Human Services, Washington, DC...................... 3
Statement of Jonathan Evans, Vice President, American Medical
Directors Association, Columbia, MD............................ 15
Statement of Tom Hlavacek, Executive Director, Alzheimer's
Association of Southeast Wisconsin, Milwaukee, WI.............. 17
Statement of Toby Edelman, Senior Policy Attorney, Center for
Medicare Advocacy, Washington, DC.............................. 19
Statement of Cheryl Phillips, Senior Vice President of Advocacy,
LeadingAge, Washington, DC..................................... 21
APPENDIX
Witness Statements for the Record
Daniel R. Levinson, Inspector General, U.S. Department of Health
and Human Services, Washington, DC, along with the May 2011
report ``Medicare Atypical Antipsychotic Drug Claims for
Elderly Nursing Home Residents''............................... 32
Patrick Conway, Director and Chief Medical Officer, Centers for
Medicare and Medicaid Services, U.S. Department of Health and
Human Services, Washington, DC................................. 88
Jonathan Evans, Vice President, American Medical Directors
Association, Columbia, MD...................................... 98
Tom Hlavacek, Executive Director, Alzheimer's Association of
Southeast Wisconsin, Milwaukee, WI............................. 102
Toby Edelman, Senior Policy Attorney, Center for Medicare
Advocacy, Washington, DC....................................... 132
Cheryl Phillips, Senior Vice President of Advocacy, LeadingAge,
Washington, DC................................................. 147
Responses to Additional Questions for the Record
Daniel R. Levinson, Inspector General, U.S. Department of Health
and Human Services, Washington, DC............................. 152
Patrick Conway, Director and Chief Medical Officer, Centers for
Medicare and Medicaid Services, U.S. Department of Health and
Human Services, Washington, DC................................. 156
Toby Edelman, Senior Policy Attorney, Center for Medicare
Advocacy, Washington, DC....................................... 161
Additional Statements Submitted for the Record
Senator Robert P. Casey, Jr. (D-PA).............................. 164
Alzheimer's Foundation of America, New York, NY.................. 166
American Health Care Association, Washington, DC................. 171
American Psychiatric Association, Arlington, VA.................. 174
American Society of Consultant Pharmacists, Alexandria, VA....... 189
California Advocates for Nursing Home Reform, San Francisco, CA.. 194
Linda J. Fullerton, Private Citizen.............................. 204
Long Term Care Community Coalition, New York, NY................. 209
National Alliance on Mental Illness, Arlington, VA............... 214
National Community Pharmacists Association, Alexandria, VA....... 218
National Consumer Voice, Washington, DC.......................... 224
National Research Center for Women & Families.................... 230
Omnicare, Washington, DC......................................... 231
OVERPRESCRIBED: THE HUMAN AND TAXPAYERS' COSTS OF ANTIPSYCHOTICS IN
NURSING HOMES
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WEDNESDAY, NOVEMBER 30, 2011
U.S. Senate,
Special Committee on Aging,
Washington, DC.
The Committee met, pursuant to notice, at 2:03 p.m. in Room
SD-G31, Dirksen Senate Office Building, Hon. Herb Kohl,
Chairman of the Committee, presiding.
Present: Senators Kohl [presiding], Manchin, Blumenthal,
and Grassley.
OPENING STATEMENT OF SENATOR HERB KOHL, CHAIRMAN
The Chairman. Good afternoon to all of you. We appreciate
your being here today, and we'll commence the hearing at this
point.
Today we will be discussing the widespread, and costly, and
often inappropriate use of antipsychotics in nursing homes, and
efforts to find safe and effective alternatives. While
antipsychotic drugs have been approved by the FDA to treat an
array of psychiatric conditions, numerous studies have
concluded that these medications can be harmful when used by
frail elders with dementia who do not have a diagnosis of
serious mental illness. In fact, the FDA issued a black box
warning, citing increased risk of death when these drugs are
used to treat elderly patients with dementia.
Despite these warnings, there has been little impact on
antipsychotic prescription rates in long-term care facilities
for dementia patients who do not have a diagnosis of psychosis.
The most recent data indicates increasing usage of
antipsychotics among nursing home residents with dementia, and
that more than half of these patients have been prescribed
these drugs.
Improper prescribing not only puts patients' health at
risk, it also leads to higher health costs. Today, we'll hear
testimony by the HHS Office of Inspector General that the use
of antipsychotics in nursing homes for patients without a
diagnosis of mental illness is costing taxpayers hundreds of
millions of dollars every year.
Now, we know that we can do better. Our second panel
features experts, including Tom Hlavacek, from my own State of
Wisconsin, who'll be discussing safe and effective alternatives
to using antipsychotics to deal with behavior issues in older
dementia patients.
When properly prescribed, antipsychotics can offer
beneficial treatment for individuals suffering from a mental
illness; however, we have a responsibility to patients and to
their families to ensure that elderly nursing home residents
are free from all types of unnecessary drugs. And we have a
responsibility to taxpayers to be sure that they're not having
to pay for drugs that are not needed. Toward that end, I'll
continue working with my committee colleagues, as well as
Senator Grassley, to address these issues.
So, we thank you all for being here, and we will turn to
our first panel.
Our first witness today will be Daniel Levinson, the
Inspector General of the U.S. Department of Health and Human
Services. We thank you for being here.
Our next witness on the panel will be Dr. Patrick Conway,
chief medical officer for the Centers of Medicare and Medicaid
Services, and director of the Office of Clinical Standards and
Quality. We thank you for being here.
Mr. Levinson.
STATEMENT OF DANIEL R. LEVINSON, INSPECTOR GENERAL, U.S.
DEPARTMENT OF HEALTH AND HUMAN SERVICES, WASHINGTON, DC
Mr. Levinson. Good afternoon, Chairman Kohl. Thank you for
the opportunity to testify about the use of atypical
antipsychotic drugs in nursing homes. These drugs are powerful,
and misuse poses a risk to the elderly.
Two recent OIG reports raise concerns about the use of
antipsychotics by elderly nursing home residents, particularly
those with dementia. We hired psychiatrists expert in treating
elderly patients to review a sample of medical records. Their
review revealed the following.
In 2007, 14 percent of nursing home residents, or nearly
305,000 patients, had Medicare claims for antipsychotic drugs.
Half of these drug claims should not have been paid for by
Medicare because the drugs were not used for medically accepted
indications. For one in five drug claims, nursing homes
dispensed these drugs in a way that violated the government
standards for their use. For example, the prescribed dose was
too high, or residents were on the medication for too long.
Finally, prescription drug plan sponsors lack access to
information necessary to ensure appropriate reimbursement of
Part D drugs, including antipsychotics.
What do these findings mean? Too many institutions fail to
comply with regulations designed to prevent over-medication,
and Medicare pays for drugs that it shouldn't. Why should we be
concerned? These powerful and, at times, dangerous drugs are
too often prescribed for uses that are not approved by the FDA
and do not qualify as medically accepted for Medicare coverage.
The FDA has imposed a black box warning emphasizing an
increased risk of death when used by elderly patients with
dementia. Yet 88 percent of the time, antipsychotics were
prescribed for elderly patients with dementia.
Physicians can use their medical judgment to prescribe
drugs for uses not approved by the FDA, including to patients
for whom the boxed warning applies. And most physicians in
nursing homes dispensed antipsychotic drugs with the best
interests of patients in mind. However, it is concerning that
so many elderly nursing home residents with dementia are
prescribed antipsychotics. For instance, without a medical
workup, one patient was given antipsychotics for agitation. A
medical exam would have detected this patient's urinary tract
infection, which may have been a source of the agitation.
How can we help protect this vulnerable population? CMS
should, one, consider enhancing claims data to ensure accurate
coverage determinations. For example, adding diagnosis codes to
drug claims could help determine whether prescribing is
appropriate and that the claim is payable. Two, hold nursing
homes accountable for unnecessary drug use through the survey
and certification process. And, three, explore other options,
such as incentive programs and provider education, to promote
compliance with quality and safety standards. For example, CMS
could require nursing homes to reimburse the Part D program
when claimed drugs violate these standards.
The government must also monitor the marketing of
antipsychotics. There is ample evidence that some drug
companies have illegally promoted these drugs for use by the
elderly with dementia. Drug manufacturers have paid billions of
dollars to settle allegations of off label marketing of these
drugs. It is difficult to undo the influence of such marketing
campaigns.
Doctors, nursing homes, and pharmacists can all help by
carefully analyzing the patient's best interests when
prescribing or dispensing antipsychotics. In partnership with
medical professionals, families can support their loved ones by
learning about appropriate use, proper dosages, and possible
side effects.
My office continues to examine protections and quality of
care for patients receiving antipsychotics. We are reviewing
whether nursing homes are completing required patient
assessments and care plans for these residents, and we have
issued guidance to nursing homes about compliance risks related
to the use of antipsychotics and other psychotropic drugs.
Over the next 18 years, 10,000 Americans will become newly
eligible for Medicare each and every day. As the baby boomer
population ages, it is imperative to address the overuse and
misuse of antipsychotic drugs among nursing home patients.
Thank you for your interest in this issue, and I'm happy to
take your questions. Thank you.
The Chairman. Thank you very much, Mr. Levinson.
Dr. Conway.
STATEMENT OF PATRICK CONWAY, DIRECTOR AND CHIEF MEDICAL
OFFICER, CENTERS FOR MEDICARE AND MEDICAID SERVICES, U.S.
DEPARTMENT OF HEALTH AND HUMAN SERVICES, WASHINGTON, DC
Dr. Conway. Chairman Kohl, thank you for the opportunity to
be here and discuss CMS' efforts to improve dementia care and
ensure antipsychotics are used appropriately. CMS is committed
to ensuring that every Medicare and Medicaid beneficiary
receives appropriate and high-quality health care.
I left the private sector to take on my current career
public servant role six months ago in order to improve the care
delivered to all Americans. This topic is a significant
opportunity for improvement, and our Nation's seniors deserve
our collective focus. I appreciate the committee's efforts to
bring attention to the issue.
CMS is undertaking a multipronged approach, engaging with
external stakeholders, to eliminate inappropriate use of
antipsychotics in nursing homes. I will briefly summarize
multiple steps that we've already taken and our plans in the
future. I will highlight seven components to our approach:
survey and certification, training and education, updating
rules that govern nursing homes, research, quality measure
development and transparency, partnering with States, and
collaborative quality improvement.
First, to help ensure that nursing homes meet both Federal
and State standards, CMS conducts inspections of all facilities
participating in Medicare or Medicaid. CMS has implemented
substantial improvements to help address concerns about over-
utilization of medications. CMS provides guidelines for
unnecessary medications, including requiring providers to use
non-pharmacologic interventions to help manage behavioral
issues, such as increasing exercise or time outdoors,
monitoring or managing pain, or planned individualized
activities.
CMS is working to enhance implementation of the guidance
and utilize our quality assessment and performance improvement
program better. The surveyors are armies of quality assurance
staff in the field, so we need to focus this resource on
appropriate behavioral interventions.
Second, CMS is working to improve training for both
providers and surveyors to provide patient centered care that
emphasizes non-pharmacologic interventions when appropriate.
CMS added language to the state operations manual to make
dementia care and abuse prevention issues a mandatory part of
training. Additionally, CMS is producing educational DVDs that
emphasize non-pharmacologic interventions. These will be
distributed nationally to all nursing homes and State survey
agencies. Finally, CMS updated the training curriculum to
improve survey or skill at detecting unnecessary medication
use.
Third, CMS is updating its rules regarding nursing homes
and antipsychotic use. CMS proposed changes that will require
long-term consultant pharmacists to be independent from LTC
pharmacies, pharmaceutical manufacturers, and distributors. The
goal is to assure that pharmacists' recommendations are made
free from a possible financial influence. CMS is considering
updates to other rules governing nursing homes.
Fourth, CMS is conducting research and leveraging research
findings into practice. For example, CMS has awarded a contract
to conduct a study in 20 to 25 nursing homes that will evaluate
nursing home decision making and factors influencing
prescribing practices for antipsychotic medications.
Fifth, CMS is seeking to encourage the development of
quality measures addressing antipsychotic medication use. Once
developed and validated, CMS would plan to publicly post the
quality measures on first on Nursing Home Compare.
Sixth, CMS is interested in partnering with States to
address this issue, and help identify and spread best
practices. For example, CMS funded work with Illinois to use
enhanced nursing home drug data to detect and monitor issues
related to antipsychotic use.
Finally, and perhaps most importantly, we have recently
engaged in a collaborative multi-stakeholder quality
improvement initiative focused on reducing antipsychotic use in
nursing homes by eliminating inappropriate use. I have
personally led and participated in national quality improvement
initiatives, and have seen their power to transform health
care. These efforts are most successful when they engage a
broad range of stakeholders, including front line clinicians,
patients, and families.
Therefore, a few months ago we began proactively reaching
out to stakeholders, including, but not limited to, the
American Medical Directors Association, the American Society of
Consultant Pharmacists, the American Health Care Association,
LeadingAge, Consumer Voice, professional societies, government
partners, and others to participate in a national
collaboration. The response has been positive, and we are in
the process of developing a national action plan. We are
committed to working collaboratively to accomplish our shared
goal.
I want to briefly share three of our guiding principles
from the CMS Office of Clinical Standards and Quality that I
led our organization in drafting.
First, constant focus on what is best for the patient;
second, being a catalyst for health system transformation and
improvement; third, collaboration across HHS and with our
external stakeholders and partners. This is our approach going
forward, both to dramatically improve the care of patients with
dementia, as well as other issues we tackle.
CMS seeks to function as a major force and trustworthy
partner for the continued improvement of health and health care
for all Americans. As a practicing physician and son of a
current and former Medicare beneficiary, I personally take this
commitment very seriously. For nursing home residents suffering
from dementia, this involves comprehensive behavioral health by
an interdisciplinary team who are knowledgeable in the use of
non-pharmacologic interventions and appropriate, judicious of
medications when indicated.
We hope that members of the committee will serve as
important partners in these efforts, and I look forward to
hearing your suggestions and comments, and answering your
questions.
As you noted, I have to mention my wife just gave birth to
our third child, Alexa Diane Conway, so if I seem sleep
deprived in my answering of questions, I apologize. Thank you
for your time.
The Chairman. Thank you very much, Dr. Conway, for being
here.
Mr. Levinson, your study found that about half of the 1.4
million atypical antipsychotic drug claims for nursing home
residents did not comply with Medicare reimbursement criteria
because they were not used for medically accepted indications.
So, how can we increase Medicare's access to the information it
needs to ensure appropriate reimbursement for drugs?
Mr. Levinson. Well, our report included several
recommendations, and in my summary statement, I was including,
you know, some of the options that I think CMS needs to
explore.
But, first and foremost, you know, if we could have
diagnosis information as part of the prescription, that would
go a long way. It wouldn't necessarily solve the entire
problem, but having the diagnosis information available on the
prescription could make potentially a significant difference in
being able to ensure that the sponsors actually understand
that, indeed, this is for a medically indicated application.
The Chairman. No, and almost every case, the prescription
comes from a physician--correct?
Mr. Levinson. Yes.
The Chairman. Well, the physician understands how he is to
prescribe for dementia and how he's to prescribe for mental
illness. So, how is this mistake being made? After all, it's
not just anybody that decides what to administer to a patient;
it's a physician. So, how does this happen?
Mr. Levinson. Well, what we are focusing on is CMS' need to
require the PDP sponsors to ensure that they have the diagnosis
information available, because if you're reimbursing only half
the time accurately, that is a problem that cries out for the
need to ensure that CMS is saying, we need to ensure that we
are only paying for those prescriptions in which we can support
either FDA or off label, but medically indicated applications.
The Chairman. And I appreciate that, but I'm trying to
somehow understand the medical part of this, because it's
dangerous to prescribe inappropriately, right? I mean, we're
talking about patients who are at risk from inappropriate
prescription.
Mr. Levinson. Well, you know, on the medical expertise, I
would defer, even if he's retired----
The Chairman. Dr. Conway----
Mr. Levinson [continuing]. The doctor at the table, but I
would indicate that doctors are free to prescribe for any
indication.
The Chairman. Sure. Dr. Conway, do you want to add, help us
understand that?
Dr. Conway. So, we agree with the point that we have a
shared goal of appropriate prescribing. I think our view of
this, as I outlined, is a multi-faceted approach to appropriate
prescribing. So, and we think about it in the course of all of
our levers.
So, on one hand, it's education and training. So, I agree
with you the decision should be between a physician and the
patient. But there probably is an additional education and
training for nursing home staff and physicians on this issue,
especially around non-pharmacologic interventions.
I think, secondly, in terms of measurement and data, we
agree with the OIG on the importance of data and on
measurement. And as I alluded to, we're looking for additional
measures so we can track this information. I won't recount
everything I went through, but I think also in survey and
certification, if there are outlier nursing homes with
potential issues, you know, we are working through a process to
make sure we have appropriate quality assurance in those
settings for those nursing homes.
The Chairman. You regard this as a solvable problem,
perhaps not easily, but a solvable problem.
Dr. Conway. I do.
The Chairman. Let me put it to you another way. Is there
any reason, other than our inattention, for patients to be
prescribed improperly?
Dr. Conway. So, I do believe it's a solvable problem. I
think it is a complex problem, exactly as you said, Senator. I
think addressing complex problems such as this, especially
where the symptoms are sometimes difficult to distinguish as
opposed to some other disease processes where it's more
obvious, and I can talk more about that if you want me to.
I think here, it is a solvable problem, but it will mean
collaborative quality improvement, as I alluded to, a
collaborative focus. And I really think one of the major keys
is this focus on non-pharmacologic treatments. So, we educate
nursing homes and patients and families about the non-
pharmacologic options to treat dementia and behavioral
disturbances with patients with dementia.
The Chairman. Do you agree with that, Mr. Levinson?
Mr. Levinson. Yeah, I think that can be extremely,
extremely helpful. That's very important. And, again, what is
truly appropriate is a matter for the doctor to decide, perhaps
in consultation with other medical professionals.
The concern from the Inspector General's standpoint is that
CMS is reimbursing half the time where we just can't establish
that there are actual medical indications that the CMS manual
requires for there to be appropriate reimbursement.
The Chairman. Okay. Senator Manchin.
Senator Manchin. Thank you, Mr. Chairman.
Dr. Conway, and if you've gone over this and I missed it
before I got here, I'm sorry. The Inspector General's report
found that over half the antipsychotic claims--about 723,000
out of a million four--for the residents did not comply with
the Medicare reimbursement criteria, which is, I think, what
Mr. Levinson was just speaking about. And, I mean, that's an
alarming rate. What authority do you need to create incentives,
or improve data, or promote compliance within the rates of non-
compliance you have now?
Dr. Conway. So, I agree that CMS should not be paying for
medically inappropriate uses of medications. I think it is an
inappropriate payment issue. It's also a quality of care issue.
As I did allude to on the survey and certification, I do think
quality measurement, which you touched on, is important, that
we're measuring quality in this area, which historically we
have not. We're working to be able to do that as early as this
spring, so I think that's a critical factor. And then,
transparently sharing that information with beneficiaries and
their families on Nursing Home Compare.
I think, in addition, with our Part D colleagues, you know,
we continue to work with PDP drug plan sponsors. We actually
recently asked for more that we could do in this area in terms
of input there.
So, I think it's a multi-faceted issue. We agree with you
that we should not be paying inappropriately. I think our
current authorities achieve that goal. Survey and certification
now reports to me. I would reiterate, you know, the President
put in the Fiscal Year '12 budget for survey and certification.
We would support that budget. It allows us to do the important
work of survey and certification in nursing homes. But I think
we have the appropriate statutory authorities currently.
And as I outlined, we're going to take a multi-faceted
approach to address this issue.
Senator Manchin. A lot of the States have basically their
own controls, their oversights, their ombudsmens, things of
this sort. Are you all exchanging your information freely? I
mean, do you all--because I looked at just the figures of
2007--$309 million was spent. Well, if half of it's spent or
misspent, it's $150 million. That was in 2007 dollars. I can
only guess what it could be right now. But how do you all
interact with States?
Dr. Conway. So, we work closely with States now, and we
think we need to do more in the future. So, we're partnering
with States. Illinois, for example, we're working with them on
analyzing their data, identifying what may be inappropriate
uses of antipsychotics. Massachusetts is convening a multi-
stakeholder group to address this issue. So, we are closely
working with States, including the State-based survey agencies
in terms of addressing this issue.
Senator Manchin. Well, aren't the States doing more
visitations than nursing homes than what you would say you are
able to do?
Dr. Conway. Yes. So, it is the State survey agencies that
will survey nursing homes----
Senator Manchin. Are they trained? Have they been trained
properly to look for the types of so-called over prescriptions
or abuse that might go on?
Dr. Conway. It's a great point. So, one of the aspects that
we are trying to address is better training. So, we've started
that through a series of, as an example, educational DVDs on
this issue. Direct training with surveyors, so teaching
surveyors and providers in nursing homes about non-
pharmacologic treatments, and we think that's a critical point,
exactly as you outlined. So, both the providers of care and the
surveyors who are understanding that that care is present
understand inappropriate use of antipsychotics, and also
understand the non-pharmacologic interventions that are
possible to treat these problems.
Senator Manchin. Here I was reading, it says, ``These
treatments are administered, despite FDA box warning concerning
increased risk of mortality when drugs are used for the
treatment of behavioral disorders in elderly patients with
dementia, and no diagnosis of psychoses.''
Is it kind of out of sight, out of mind, keep them calm, or
what?
Dr. Conway. So, that would not be our goal.
Senator Manchin. I know it's not your goal. It looks like
what the results have been.
Dr. Conway. So, on the FDA label, so, as you know, many
medications are prescribed off label. However, we would always
want appropriate use of antipsychotics. So, to give some
tangible examples, if a patient with dementia has delusions, or
hallucinations, or, you know, serious mental disturbances, then
that can be appropriate use. But we would like to have the non-
pharmacologic treatments be used more often.
Senator Manchin. Let me just say, sir, it's really a shame
in this great country, as much money as we spend on nursing
home care, not to get a better quality of care for the people
that are in need. It just really is non-excusable.
Dr. Conway. I agree that it's a shame, and I agree that we
need to do better.
Senator Manchin. Thank you.
The Chairman. Thank you, Senator Manchin.
Senator Grassley.
Senator Grassley. Thank you, Mr. Chairman. I appreciate the
opportunity and the invitation to come and participate in this
hearing. Thank you.
I have just one question for each of you. I'll start with
General Levinson. In your testimony, you highlighted the
extensive evidence that drug companies have illegally marketed
their atypical antipsychotics for off label use. You mentioned
one company that used the slogan ``Five at Five'' to promote
their powerful antipsychotic as a sleep aid for patients. Eli
Lilly sales representatives told the doctors that giving five
milligrams of their drug, Zyprexa, at 5:00 p.m. would help
their patients sleep.
In 2009, this company pled guilty to illegal promotion and
paid one and four-tenths billion dollars to settle a Federal
lawsuit. Compared to the revenue this blockbuster drug
generated, that large number becomes less significant, and
unfortunately just the cost of doing business.
Now, as you described, it is a profitable investment
because even after government action stops illegal marketing,
their effect on prescribing patterns may be long lasting and
difficult to undo.
So, my two-part question, General Levinson, is there a
system currently in place to educate prescribers in response to
this misleading promotion of drugs?
Mr. Levinson. Provider training is absolutely essential,
Senator Grassley. And whatever is in place now needs to be far
more robust. That is a key takeaway, I would hope, from what
has been examined and what has been reported on, is that there
needs to be far greater understanding of the potency of these
drugs and their appropriate application, and how if you're
going to use the backdoor as opposed to the front door of
advancing this kind of drug regimen, it really needs to come
with a really good understanding of what people are doing.
And it's hard to believe that in the past, that really has
been effective, just given the record of litigation, because
we've had not just that case, but nearly a half a dozen major
settlements with drug companies over the past several years,
totaling billions of dollars, that in one way or another
involve these antipsychotic drugs.
So, it's a very important key part of the puzzle, if you
will, that needs to be really made far--it really needs to be
strengthened. And we're doing our part trying to advance the
provider training initiatives. And we're going to continue on
quality of care to do much the same by drilling down and
understanding individual plans of care to see exactly how
nursing homes are actually trying to implement a far more
effective plan for patient safety.
Senator Grassley. Okay. If there is such a system, it's
inadequate, you just said, and needs to be improved or maybe
even replaced. Do you have some idea how that system should be,
and is it possible, if it needs more money, using a portion of
the settlements of off labeled marketing?
Mr. Levinson. Well, we would certainly stand very ready, as
we always have, to provide the kind of technical assistance
that we do day in and day out to CMS, which really has the
program responsibility to design these kinds of efforts. We
don't run the program; we evaluate it.
In terms of a kind of a counter design, my chief concern
would be how we would oversee how the government would actively
seek to provide some kind of counter balance to it. Wearing the
oversight hat, that presents some challenging issues about how
you, I take it, level the playing field, make sure people
understand pros and cons comprehensively.
So, I mean, that would be a significant oversight
challenge, and, therefore, it would be important to get the
details of that kind of design right. And we would stand ready
to certainly help.
Senator Grassley. Okay. Dr. Conway, you mentioned proposed
changes CMS is considering to require long-term care
pharmacists to be independent from other pharmaceutical
interests. Currently, about 80 percent of the consultant
pharmacists at long-term care facilities are employed by long-
term care pharmacies. There is then obviously a clear potential
for conflict of interest.
However, one large long-term care pharmacy reported to me,
and I won't give the name of that group, that all of the
antipsychotic recommendations made by their consultant
pharmacists, 99 and seven-tenths percent of those
recommendations were to reduce or discontinue the antipsychotic
dosage. One problem they presented was that these
recommendations are often rejected by prescribing doctors who
believe that high dosage is appropriate.
Does CMS keep data on recommendations made by consultant
pharmacists on whether or not they're implemented?
Let me ask at the same time, does CMS require justification
from a prescribing physician when they choose not to follow
recommendations? So, two questions.
Dr. Conway. Yes, sir. So, on the first question, we are not
currently capturing data on recommendations from the long-term
care pharmacists to physicians because that's within the
nursing home care setting. I think, as I alluded to earlier, I
think the education component is not just in the pharmacy
world; it's also to physicians. I'd also say it's to patients
and their families, caregivers, nurses, CNAs, so the whole
nursing home community, if you will, which we think will make
it a much more receptive audience to recommendations.
On the long-term care pharmacy issue, you know, it is a
proposed change. And as you alluded, the proposal was an
attempt to ensure that financial arrangements weren't
influencing the recommendations from the long-term care
pharmacists.
Senator Grassley. What about the--I hope you didn't answer
this. If you did, I didn't get it. Does CMS require
justification for the--from the prescribing physician when they
choose not to follow recommendations?
Dr. Conway. I apologize, sir. I didn't answer the second
part.
So, we currently do not require a written justification per
se. It is similar to other prescribed medicines. The physician
and the patient should have a discussion about the medication,
the risks and benefits, or the patients' family in this case.
And then, the prescription, either to increase or decrease in
dose, or stopping a prescription would take place. But like
other prescribed medicines, there's not a justification--a
written justification captured for the prescription.
Senator Grassley. Thank you very much, Mr. Chairman. And
thank you, witnesses.
Dr. Conway. Thank you, sir.
The Chairman. Thank you very much, Senator Grassley.
Senator Blumenthal.
Senator Blumenthal. Thank you, Mr. Chairman. And, first of
all, my thanks to our chairman, Senator Kohl, for having this
very important hearing, and for Senator Grassley's continuing
investigation into this issue, which has been very, very
important.
Over use of antipsychotics, as I don't need to tell the two
witnesses and probably most of the people who are attending
today, is a form of elder abuse, plain and simple. It's a form
of abuse of people who often have no idea what is happening,
and even their families may not have a clear or informed idea
about how these drugs are prescribed and applied. And it occurs
not just in occasional or isolated case, but as a routine
pattern and practice, as some of the statistics show.
I don't know how many of them have been cited here, but 83
percent of claims for use of these antipsychotics to Medicare
were associated with off label conditions like dementia. Fifty-
one percent of Medicare claims for these drugs were erroneous.
And, of course, millions of dollars wasted.
So, the question is, at the outset, if there is off label
marketing, which is plainly a violation of current law as
opposed to off label prescription which may not be, can you
give me specific instances--both of you cited in your testimony
of off label marketing occurring. What companies, what drugs?
Mr. Levinson. We've had a number of cases, and of the 18
settlements that we've had, Senator Blumenthal, I believe five
in the past few years have involved antipsychotic drugs.
Senator Blumenthal. I'm thinking more of going forward of
what's occurring right now.
Mr. Levinson. Well, I can give you past cases, but in terms
of current investigations, I certainly wouldn't be in a
position. It would be in--it's something that wouldn't be
proper to be talking about whatever current investigations
might be ongoing with us as investigators in the Justice
Department, as the prosecutors. But we have certainly a record
of the kinds of cases you described that I think are a very
important body of work that really underlay our evaluation work
that we undertook to see further exactly how extensive the
problem is in nursing homes with the percentages, and then to
build on that work by looking at patient plans of care.
So, the litigation work that we have been involved with, in
partnership with the Justice Department, lay the foundation for
the report that's now before you, at least in part. And the
report that's now before you will add further information and
understanding to what is actually going on, if you will, on the
ground, and will lead to a further investigation of plans of
care in nursing homes to see how the mechanics of this actually
is either operating or not operating appropriately.
Senator Blumenthal. Are the penalties for off label
marketing, in your view, sufficient to deter it in this area?
Mr. Levinson. Well, I mean, that's--you know, based on the
record, it looks as if we're still facing a significant health
issue. There's no question about that.
Senator Blumenthal. Exactly, right. So, I think the answer
probably is no.
Mr. Levinson. But that might be for others, you know, to
answer. But I----
Senator Blumenthal. Well, you're in charge of enforcement--
--
Mr. Levinson. Well, based on enforcement, we have quite an
enforcement record at this point that we've built----
Senator Blumenthal. Which is why I'm asking you the
question. If anyone is expert on the issue of deterrence, it is
you, and that's why I'm asking you the question.
Mr. Levinson. Well, we certainly view these kinds of
returns, and we're talking about billions of dollars as a
considerable amount of money. What happens with respect to the
kind of cross-benefit evaluations that are undertaken by
others, it's certainly very, very troubling that we have not
just a case, but we do have a string of cases. And, therefore,
you know, there's plainly a need to do more.
Senator Blumenthal. In this area, would you suggest that
there ought to be specific prohibitions applicable to the
providers, in addition to the companies, for off label use in
the area of use of antipsychotics for nursing home treatment?
Mr. Levinson. Well, I mean, I think in the context of anti-
kickback statute, and, you know, we've had some cases in which
we have actually pursued at the provider level. I do think
everybody needs to take ownership of the problem throughout the
health care system, and it's not just a matter of the folks who
are actually producing the drugs. I would agree with that.
Senator Blumenthal. So, perhaps in the area of nursing
care, the penalties for off label marketing should be also
applicable to providers, or there's some institutional
responsibility for off label use?
Mr. Levinson. Well, on the institutional responsibility,
one of the chief concerns we have, as reflected in this report,
is that more than 20 percent of the time, even when the drugs
were used for medically accepted indications, they were being
used for too long or improper dosages; that there's a lot of
misapplication that's actually going on within the nursing home
setting itself. And I think that we haven't really talked about
that this afternoon, but that is equally concerning.
Senator Blumenthal. Thank you very much.
Thank you, Mr. Chairman.
The Chairman. In testimony that you've both made, and from
what we've heard from other sources, it's been noted that rules
to combat, which some refer to as chemical restraints, have
been in place for many years now. So then, why are there still
such high rates of over utilization of medications that appear
in many cases to be used as a shortcut for proper care by well-
trained staff? What's behind this all?
Mr. Levinson. Well, Chairman Kohl, I mean, I think that's
what we need to further examine, and that's why I emphasized
the follow-up reporting that we're going to be doing. And I
certainly will defer to Dr. Conway to give his kind of medical
perspective on it.
But we don't begin this kind of evaluation with any goal of
what is the right number of dosages, or how many prescriptions
should be allocated to this particular part of either the drug
world or these kinds of issues. We look at what CMS requires in
terms of what is reimbursable and what isn't, and that kind of
gives us our roadmap.
It obviously concerns a considerable percentage of elderly
nursing home residents with a great deal of money involved. And
as we've talked the last few minutes about the enormous
investment of dollars from the pharmaceutical industry, there's
a lot at stake here. And given how much is at stake here, both
in terms of patient safety and financial investment, I think
all of us as public officials need to do our part to make sure
that there's a much better transparent and accountable
understanding of exactly how these very powerful, important,
and very positive drugs in the right setting need to be used
and need to be paid for.
The Chairman. Are you of the opinion that in the year to
come there's going to be significant improvement?
Mr. Levinson. I'm very careful in the inspector general's
role not to predict so much as to evaluate what has happened,
and certainly try to advance recommendations that will, you
know, provide positive outcomes in the future. But in terms of
what people will do either in response to this report, we hope
that they'll take actions that indeed will fulfill, you know,
that kind of positive prediction.
The Chairman. What about you, Dr. Conway? Do you think
we're going to make some significant improvement in the next
year?
Dr. Conway. I do think we have the right components in
place to make significant improvements. So, specifically I
think engaging in the multi-collaborative approach, as I
outlined, you know, whether it's LeadingAge, ADMA, so many of
the other folks in the room here, I think we've met a very
receptive audience. I think behavioral change is complex, and
we're asking for a behavioral change away from a medication
based regimen in many cases to a non-pharmacologic treatment
regimen.
But I think, as I outlined, if we align the levers of
survey and certification, quality measurement and reporting,
education and training, and a true quality improvement
collaborative focused on this goal, which I think, you know, we
have drafts of a national action plan, you know, working with
these external stakeholders, I think that we have the potential
for significant improvement.
The Chairman. Senator Manchin.
Senator Manchin. Thank you, Mr. Chairman.
And, if I could, just ask the question. This didn't happen
overnight. This has been, I mean, you've seen the telltale
signs for quite some time, the increased amount of
reimbursements probably that you were making for these types of
drugs, and how that's grown in pretty rapid succession. Didn't
it raise anyone's alarm? Did anybody's alarm go off that
something could be wrong?
Dr. Conway. I'll start to try to answer that question.
Senator Manchin. I'm just saying, when I look back at the
years and the increases of reimbursements, that means increased
usage. Is there other things like this that would be a telltale
sign that there's abuses going on that basically haven't come
to the forefront, that you all can see the change in
reimbursement that should've told us that something needed to
be done much sooner than this? Go ahead. Either one.
Dr. Conway. I'll start, and then----
Senator Manchin. Sure.
Dr. Conway. So, I think certainly this is an issue, and in
the interest of full disclosure, I'm interested, so I can't--
I've been in this role for six months, so I can't speak to the
history as specifically prior to that. But I think this is an
issue that there was awareness of. I think that the awareness
has grown. I think at CMS, we have some things already on this
issue in terms of guidance, survey, and certification, et
cetera. I think we have much more to do. So, I think----
And then, on this sort of coverage and reimbursement
issues, I'd largely defer to my Medicare and reimbursement
colleagues on the coverage and reimbursement issues.
Mr. Levinson. And the kind of reporting that we did does
take time. I mean, we're looking at--in our report, we looked
at the first half of 2007, and we asked medical experts to
actually do the medical record review. And, therefore, we're
looking at information that is now several years old. But we
do, and we've been involved in the cases that resulted in
significant settlements with pharmaceutical industries on these
kinds of drugs for the last few years.
So, you know, we know that this is a--this has been a very
large issue for us on that litigation front. As part of the
settlements, there have been corporate integrity agreements----
Senator Manchin. Sure.
Mr. Levinson [continuing]. That these companies have had to
sign with very robust compliance requirements that we in turn
are in the process of monitoring.
Senator Manchin. Do you all have any litigation going on
right now with any companies that you know of, or that you
probably suspected any type of fraud whatsoever?
Mr. Levinson. Well, chances are my counsel in my Office of
Investigations would advise me not to talk in public about
ongoing investigations, and I try to adhere to their guidance.
Senator Manchin. That's a good policy to follow.
The only thing that bothers me more than anything is that--
how much fraud, abuse, and waste that goes on in the whole
system. If in anybody's budget, if we see a spike in
reimbursements--requests for reimbursements, that should alarm
that something's wrong. It's the easy way out, and it's the
most profitable way, or you're sweeping it under the rug. I
mean, I don't know why if someone's evaluating this, whether it
be your medical staff or whatever, where does the flag go off
or why--that's why I keep asking the same question, I know. But
then, maybe you need to change your all's overview or
oversight.
Mr. Levinson. I do think that there is considerable promise
in the initiative of accountable care organizations, of
coordinated or integrated care, to get health care
professionals and different corners of the health care industry
doing business with each other in a more integrated way than
has existed in the past.
That does have promise to, in effect, serve as a very
useful way of people being able to understand what kinds of
therapies, whether it's pharmacological or otherwise, make the
most sense for the patient. After all, we're dealing with a
system in which the great majority of health care providers are
honest. They are professional. They are trustworthy. They are
people who we really count on to take care of us and our
families. And the great majority of the time, they do so.
So, what we need to have is a system that really brings out
those strengths and keeps the weaknesses, the marginal players
out of the system entirely, or at least at bay, so that we
don't have an issue that is as serious as this on both safety
and financial grounds. And I think that that's a very good,
positive development that I know CMS and other parts of HHS are
now in the midst of unrolling, you know, this coming year and
in the future. And I'm hopeful that it will have benefits on
the health care fraud and abuse front as well.
The Chairman. We thank you both for being here today.
You've added a lot to the discussion of this important issue.
Thank you so much.
We'll now turn to our second panel. On the second panel,
we'll have four distinguished witnesses.
First, we'll be hearing from Dr. Jonathan Evans, who's the
incoming president of the American Medical Directors
Association. Next, we'll be hearing from Tom Hlavacek. Mr.
Hlavacek currently serves as executive director of the
Alzheimer's Association of Southeastern Wisconsin. Our third
witness will be Toby Edelman, senior policy attorney for the
Center for Medicare Advocacy. And then, we'll be hearing from
Dr. Cheryl Phillips, who's a senior vice president of advocacy
at LeadingAge.
We thank you all for being here. And now, Dr. Evans, you
may commence.
STATEMENT OF DR. JONATHAN EVANS, VICE PRESIDENT, AMERICAN
MEDICAL DIRECTORS ASSOCIATION, COLUMBIA, MD
Dr. Evans. Good afternoon, and thank you, Mr. Chairman, and
members of the committee for allowing me the great privilege of
appearing before you today.
Although my testimony today is quite personal, I also
represent AMDA, the professional society for long-term care
physicians, whose mission is to improve the quality of care for
seniors.
My personal story is this. I'm a doctor who specializes in
the care of frail elders. I practiced mostly in nursing homes
and other long-term care settings, where physicians are
frequently absent. I do use antipsychotic drugs to treat a
small number of patients with long-standing schizophrenia or
bipolar disorder. I do not prescribe antipsychotic job drugs
for treatment of agitation or other behaviors in patients with
dementia.
The entire leadership of AMDA acknowledges the use of these
medicines in patients with dementia only as a last resort, and
only when all else has been tried and failed, which is rare. I,
and other like-minded doctors, face tremendous pressure and all
care settings to prescribe medication to make confused patients
behave. Most of the time, this equates to chemically
restraining the patient. This pressure comes from frustrated
caregivers and family members, who are then led by other health
care professionals to believe that these drugs are essential. A
large number of patients that I see were started on
antipsychotic drugs in the hospital for reasons that are
entirely unknown. I routinely stop these and many other
unnecessary or inappropriate drugs in patients admitted to my
care. Nevertheless, my efforts to avoid or eliminate
antipsychotic drugs often put me at odds with facility staff,
patients and families, and other health care professionals.
The rate of off label antipsychotic drug use varies greatly
between facilities and prescribers, and it's based upon their
culture and attitudes, and not based upon medical diagnoses,
severity of illness, or symptoms. Federal regulations regarding
antipsychotic drugs, unnecessary medications, and chemical
restraints only applies to nursing homes, but the problem of
over prescribing antipsychotic drugs exists at all care
settings. The majority of all off label antipsychotic drug
prescribing occurs outside of nursing homes.
There is a firm fixed belief among many health care
professionals that undesirable behavior is cause for
medication, and that medication will be very likely to work.
That firm fixed belief is false, but it's based in part on
inadequate training to understand behavior and care for
confused patients. Most doctors treat unwelcome behavior in all
settings as a disease that requires medication. These drugs are
used as chemical restraints. The real concern should be for
improved dementia care in all settings that focuses on
understanding behavior and its meaning in order to meet the
patient's needs.
Most of the time, using drugs to stop behavior isn't doing
the right thing; using drugs is instead of the right thing.
Using drugs to try to make people behave creates unrealistic
expectations and distracts caregivers from solving the
underlying problems, resulting in these behaviors. Behavior is
not a disease. Behavior is communication, and people who have
lost the ability to communicate with words, the only way to
communicate is through behavior. Good care demands that we
figure out what they are telling us and help them.
Undesirable behavior and dementia is usually reactive and
occurs in response to a perceived threat or other
misunderstanding in patients who, by the very definition of
their disease, have lost some ability to understand. These
behaviors represent a conflict between a patient and their
environment, us. Often we have to change our behavior in order
to present an undesirable, but an entirely predictable,
response.
AMDA believes in and promotes a multidisciplinary team
approach to patient centered care, and is working with others
to change the culture of health care in the United States. A
minimum requirement of patient centered care is informed
consent. Patients and their families must be afforded
sufficient information and dialogue to make appropriate
treatment decisions regarding potentially harmful medications.
Likewise, we respect and strongly agree with existing Federal
regulations regarding the avoidance of chemical restraints and
unnecessary drugs.
We're developing core competencies for physicians in long-
term care. We are raising the bar for dementia care, and
helping dedicated and caring individuals to leap over that bar.
We're educating and empowering physicians, medical directors,
and attending physicians and long-term care, and we believe
that these efforts will lead to the kind of health care quality
that we all want without increasing costs.
There's no substitute for good doctor spending time with
their patients and families, time that they need to solve
problems and relieve suffering. Doctors who are more often
present and engaged in nursing facility care use fewer health
care resources and fewer antipsychotic drugs. Physician
training doesn't work to reduce antipsychotic drugs, and AMDA
provides training on good dementia care and is working to
provide more.
We acknowledge that virtually every dollar of health care
spending at some point occurred as a result of the doctor's
order.
Being a good physician requires being a good steward of
scarce resources and focusing on what works. What the money is
spent on should be a reflection of what we value most as a
society. What my colleagues and I value most is loving care.
Thank you, Mr. Chairman, and members of the Committee.
The Chairman. Thank you very much, Dr. Evans.
Mr. Hlavacek.
STATEMENT OF TOM HLAVACEK, EXECUTIVE DIRECTOR, ALZHEIMER'S
ASSOCIATION OF SOUTHEAST WISCONSIN, MILWAUKEE, WI
Mr. Hlavacek. Good afternoon, Chairman Kohl and Senator
Manchin. Thank you for the opportunity to discuss the very
serious problems that overutilization of atypical
antipsychotics present for people with Alzheimer's disease,
particularly those who reside in long-term care.
Unfortunately, the Alzheimer's community in Wisconsin has
seen firsthand what can happen when an individual with dementia
is prescribed antipsychotics without proper precautions. At the
time of his death, Richard ``Stretch'' Petersen, a friend of
Senator Kohl's, was an 80-year-old gentleman with late stage
dementia, who exhibited challenging behaviors in a long-term
care facility.
After being at two hospitals in an effort to have his
behaviors treated with antipsychotics, he was placed under
emergency detention and was transferred by police in a squad
car in handcuffs to the Milwaukee County Behavioral Health
Psychiatric Crisis Unit. His family found him there, tied in a
wheelchair with no jacket or shoes. In spite of his family's
efforts to intervene and seek better care, he very quickly
developed pneumonia, was transferred to a hospital, and died.
Richard Petersen worked hard all his life, raised his
family, and contributed to his community in many ways. He did
not deserve to die in the way that he did.
Mr. Petersen's death was not an isolated incident. It was
the latest in a string of incidents in southeastern Wisconsin
that involve tragic outcomes related to Alzheimer's behaviors
and antipsychotic medications. In response to the growing
problem, the Alzheimer's Association of Southeast Wisconsin and
other concerned stakeholders created the Alzheimer's
Challenging Behaviors Task Force. Our local task force
eventually included 115 members from all perspectives on the
issue, and published ``Handcuff,'' a report that provides a
basic understanding of issues surrounding behaviors, and
approaches to addressing the problem.
In Wisconsin, we found a reliance on atypical
antipsychotics that were sometimes very poorly prescribed and
administered. We found examples of untreated medical
conditions, such as urinary tract infections, tooth decay, and
arthritic pain, that led to agitated behaviors. And, of course,
atypical antipsychotics will do nothing to treat those
underlying medical conditions.
We also found negative outcomes from the revocation of
individuals in and out of hospitals and long-term care
facilities. Our experience indicates that these care
transitions can exacerbate to say behaviors, and often lead to
escalating drug treatments.
The task force is one local example of how the Alzheimer's
Association advocates for quality care and long-term care
settings across the country, including the reduction of
inappropriate use of antipsychotics. Recently, the National
Alzheimer's Association board of directors approved a position
statement titled, ``Challenging Behaviors,'' which discusses
the treatment of behavioral and psychotic symptoms of dementia,
otherwise known as BPSD. The Association maintains the position
that non-pharmacological approaches should be tried as first-
line alternatives for the treatment of BPSD. I have included
``Hancuffs'' and the board's statement with my written
testimony.
The Alzheimer's Association strongly believes one mechanism
for reducing care transitions and improving overall care for
residents in long-term care is to raise the level of expertise
of facilities staff through training and education. The
Alzheimer's Association has developed two dementia care
training programs specifically for staff--the classroom-based
Foundations of Dementia Care, and the online CARES program.
Both of these training programs have been identified by CMS as
options for nursing facilities to satisfy the requirements of
Section 6121 of the Affordable Care Act, which calls for
dementia care training for certified nurse aides working in
nursing homes.
The CARES program has a new module, dementia-related
behavior, that focuses on non-pharmacological strategies for
reducing or eliminating challenging behaviors. Local
Alzheimer's Association chapters across the country are
excellent resources for these and other training programs to
enhance care and support for persons with dementia and
caregivers.
The Alzheimer's Association also developed dementia care
practice recommendations for assisted living residences and
nursing homes. These are the basis for our campaign for quality
residential care. The standards of care will improve quality of
life for people with dementia.
The Alzheimer's Association is committed to ensuring people
with dementia have access to high-quality care and strongly
believes that non-pharmacological approaches should be tried as
the first line alternative for the treatment of behaviors.
Senator Kohl and Mr. Manchin, thank you for the opportunity
to address this issue, and we look forward to the opportunity
to work with the committee in the future.
The Chairman. Thank you very much, Mr. Hlavacek.
Ms. Edelman.
STATEMENT OF TOBY EDELMAN, SENIOR POLICY ATTORNEY, CENTER FOR
MEDICARE ADVOCACY, WASHINGTON, DC
Ms. Edelman. Thank you, Senator Kohl, and Senator Manchin.
Congressional attention to the misuse of antipsychotic
drugs as chemical restraints is long standing. In 1975, this
committee issued a report, ``Drugs in Nursing Homes: Misuse,
High Costs, and Kickbacks.'' Twenty years ago, this committee
held a workshop on reducing the use of chemical restraints in
nursing homes that identified many of the same issues we're
discussing today--the misuse of drugs and the need for staff to
see residents' behaviors as communication, not problems.
The Inspector General's very important May report actually
understates the extent of the problem because it focused only
on atypical antipsychotics, not conventional antipsychotics as
well. Nursing facilities' self-reported data indicate that in
the third quarter of 2010, 26.2 percent of residents had
received antipsychotic drugs in the previous seven days. That's
approximately 350,000 individuals. Facilities reported to CMA
that they gave antipsychotic drugs to many residents who did
not have a psychosis, including almost 40 percent of residents
at high risk because of behavior issues.
I want to make just several brief points this afternoon.
First, Federal law prohibits the antipsychotic drug practices
we see in many facilities. Secondly, why are antipsychotic
drugs so misused? Third, the high financial cost of these
drugs, and, finally, some solutions.
The Federal Nursing Home Reform Law, since 1990, has
limited the use of pharmacological drugs. Implementing
regulations and CMS guidance to surveyors are very strong, but
they are inadequately and ineffectively enforced.
Second, while there are many reasons why these drugs are
inappropriately prescribed, the most significant cause is the
serious understaffing in nursing facilities. Most facilities
don't have enough staff or enough staff with specialized and
professional training to meet the residents' needs. In
addition, the enormous turnover in staff and the lack of
consistent assignment of staff to residents, mean that staff
don't know the residents they're caring for. They're less able
to recognize and understand residents' non-verbal
communications or changes in condition that could warrant an
appropriate care intervention.
A second key reason for misuse of these drugs is the
aggressive off label marketing of antipsychotic drugs, which
we've talked about today. To give one example, in 2009 the Eli
Lilly Company paid $1.5 billion to settle civil and criminal
charges for the off label promotion of Zyprexa as a treatment
for dementia. Eli Lilly had trained its long-term care sales
force to promote the drug as a treatment for dementia,
depression, anxiety, and sleep problems.
A third concern is that many consultant pharmacists who are
critical to implementing the Federal provisions about drug
regimen review have not been independent. Another false claims
act case against Johnson and Johnson charged that company with
paying kickbacks to Omnicare, the largest nursing home
pharmacy, so that the pharmacists would recommend its drugs,
including Risperdal, for use by residents. The consultant
pharmacists were part of the sales force.
There are other reasons as well, of course. Drugs have
replaced physical restraints, whose use has declined. And
antipsychotic drugs are a protected class under Medicare Part
D, and they're generally not subject to utilization control
mechanisms.
I'd to discuss briefly the high cost of antipsychotic
drugs. They're very expensive, the top selling drugs in the
United States generating annual revenues of $14.6 billion. But
the costs, of course, extend far beyond the costs of the drugs
themselves. Residents who are inappropriately given these drugs
experience a number of bad outcomes that are expensive to try
to correct. Falls, hip fractures, urinary incontinence, each
with a high price tag, can be the result of the misuse of
antipsychotic drugs.
Millions and billions of dollars that these poor outcomes
cost were identified in the 20-year-old report by the Senate
Labor and Human Resources Subcommittee on Aging, and by a
report issued this past April by Consumer Voice. Links are in
my testimony.
For solutions, what we recommend is implementing what
virtually all commenters on all sides of this issue agree on,
that non-pharmacological approaches should be tried first. To
achieve that end, we recommend a number of approaches that
would call prescribers' attention to the issue of antipsychotic
drug use, slow down the process of prescribing these drugs,
teach better non-drug alternatives, and create and impose
stronger sanctions for inappropriate use.
Finally, I want to describe what eliminating antipsychotic
drugs can mean for individual residents. A researcher working
in New York to try to translate the research literature into
practice at nursing homes sent me an e-mail about a small
facility she had spoken with. She said that the director of
nursing heard her speak, and although the nurse had originally
been skeptical, she involved her medical director and
consultant pharmacist. They were left with only two residents
using antipsychotic drugs, both with a diagnosis of
schizophrenia. And then this is what she said.
One man they found had severe back pain from spinal injury
from a car accident years ago that was never addressed, but his
dementia prevented his communicating the pain, and they had him
in a deep seated Geri chair, which only exacerbated the pain,
poor man. So, he had behavior issues and was on antipsychotic
meds, couldn't communicate, or feed himself. He now eats lunch
in the dining room and converses with his wife, participates in
activities, et cetera. They have taken away the antipsychotics
and replaced them with pain medication. One story makes it all
worth it. I would add that this story could be replicated
hundreds of thousands of times in nursing homes across the
country.
Drastically reducing the use of antipsychotic drugs would
improve the lives of residents--hundreds of thousands of
residents--and save hundreds of millions, if not billions, of
dollars. After 35 years of studies, reports, and hearings, it's
time to eliminate the epidemic use of antipsychotic drugs.
Thank you, sir
The Chairman. Thank you very much, Ms. Edelman.
Dr. Phillips.
STATEMENT OF CHERYL PHILLIPS, SENIOR VICE PRESIDENT OF
ADVOCACY, LEADINGAGE, WASHINGTON, DC
Dr. Phillips. Thank you, Chairman Kohl. And thank you for
addressing, one, this critical issue, and for involving all of
us as witnesses, because there is an important story to be told
here. And we appreciate it.
As way of background, my name is Cheryl Phillips, and I'm a
fellowship trained geriatrician. And I, like my friends and
colleagues, have spent several decades in clinical practice,
predominantly in the long-term care setting. I now have the
privilege of being the senior vice president of advocacy at
LeadingAge, formally known as the American Association of Homes
and Services for the Aging.
The 5,700 members of LeadingAge serve as many as two
million people a day through their mission driven, not-for-
profit organizations that offer a spectrum of services across a
post-acute and long-term care continuum. And together we
advance policies, promote practices, conduct research support,
enable and empower people to live as fully as they can. So, not
only do we embrace this issue as a critical, important
platform, we're going to talk a lot about how both our members
are participating, and how we are offering some solutions.
We've heard a lot about the demographics. It's worth noting
that of seniors 80 years and older with a diagnosis of
dementia, 75 percent will spend time in a long-term care
setting. So, this is an important and relevant platform
conversation. And even by CMS's own reports, 50 to 75 percent
of long-stay nursing home residents have some degree of
dementia.
But, as I say that, it's important to note that this is
neither just a nursing home issue, nor just a U.S. issue. As
part of my testimony, I included some materials that were
shared from the United Kingdom, and Dr. Banerjee, who looked at
the problem of both medication use and appropriate care of
dementia across hospitals, outpatient, and nursing home
settings, gave 11 recommendations that I think, despite the
large pool of water between our two countries, has a lot of
application that we can take and use in our thinking today.
So, I would start with the use, and we've mentioned it, but
it's worth noting again, that the use of antipsychotics is
related to a much larger challenge of how to best care for
people with dementia. Medications are most often used as a
first line of option because, quite frankly, families,
caregivers, nurses, doctors across all settings of care, are
not aware and don't even know of alternatives. They do believe
that they are doing the right thing for the person that they
love, or the person they're caring for.
It is I'll also add just a note of caution, if we merely
target this as a one class of drug, in one setting, we may have
some unintended consequences. For instance, if we look at just
one narrow scope of drugs, what will happen is that prescribers
will shift to other equally inappropriate drugs, such as
Benzodiazepines, sedative hypnotics, and off label use of anti-
seizure medicines, all of these which also carry a risk of
falls, confusion, and death.
So, it's bigger than a drug problem, although the drug
becomes the tip of the iceberg of what the underlying issue is.
We've also addressed that it's not just a nursing home
problem, and if we focus just on the solutions in the nursing
home, I do caution that we don't create inappropriate barriers
to access for people who desperately need appropriate nursing
home care.
So I think that the short-term solution is in fact not a
short-term solution, but a twofold strategy that ties into a
longer, sustained culture change. First is the application of
non-pharmacologic interventions, and we've talked about
behavior therapies. And second is when medications are used,
there is the need for close monitoring of appropriate and
limited use.
We've heard from the CMS that there are existing
regulations. I won't go over them again. I will distill them,
because when I worked with my own patients and with staff in
nursing homes, we really narrowed it down to five simple
questions. What is the specific indication, not why you want to
use a drug, but for that person, what is the valid indication?
If there was an appropriate indication, is it still appropriate
now? Maybe the issue was a day ago, a week ago, the transition
has happened, the agitation is resolved, the pain has been more
appropriately addressed.
If the person is on an antipsychotic, is it actually
working? Is what you're trying to address, have you documented
its effectiveness? And I always use the standard, is the person
that are able to function in their environment on the
medicines, then off.
Fourthly, has the family or caregivers been involved in the
choice? Are they aware of the indications, the risks, and
potential benefits, and have they been engaged in that
discussion? And is there a history of appropriate non-
pharmacologic intervention, unless this was a short-term
emergency?
So, if the answer to any of these five questions is no or
unknown, then the meds should not be started or be
discontinued.
The long-term answer, because we know that dealing with the
meds alone isn't the solution, is much how we looked at
physical restraint reduction that my colleague, Toby, referred
to. It comes from a sustained campaign where caregivers focus
on real person-centered care alternatives, including direct
workforce training with evidence-based tools, dissemination of
knowledge to nurses and physicians regarding true effectiveness
of non-pharmacologic interventions, and an interdisciplinary
team true monitoring when medications are used to ensure
appropriate indication dose, duration, and response. This will
all take a collaborative partnership. It includes CMS staff,
physicians across the health care continuum, not just in the
nursing homes, pharmacists, direct care workforce, and
caregivers.
We need accurate data to look at timely information to
feedback to prescribers. We need large-scale applied research
to look at how these models can be disseminated widely. We
certainly need enhanced survey or training as was mentioned.
And we need investment in meaningful workforce.
We at Leading Age talk about some solutions. Again, as the
not-for-profit difference we have convened a workgroup already
looking at exciting models. A couple that I'll mention, Eliza
Jennings in Cleveland and Ecumen in Minnesota, that are taking
that same philosophy of medication free treatment to dementia,
working through remarkable behavior interventions and
alternatives.
And, lastly, I want to acknowledge that LeadingAge is a co-
convener of Advancing Excellence that represents truly a multi-
stakeholder coalition that's committed to improving quality
care for life for people in nursing homes.
So, in summary, yes, we have a significant problem with
inappropriate use. The solution is how we better take care of
persons with dementia, which includes focusing on dignity,
compassion, having an across-the-board approach that involves
direct caregivers, staff, prescribers, physicians, nurses, and
families, and their loved ones, as all part of the caregiver
team. And we set the challenge that actually nursing homes
should not be the problem, but we believe they can be the
centers of excellence for improving dementia care, and a
learning laboratory for the rest of the health care setting.
Thank you very much.
The Chairman. Thank you very much, Dr. Phillips.
Dr. Evans.
Dr. Evans. Sir?
The Chairman. You argue that using antipsychotics for
patients with dementia should only occur as a last resort, and
only when all other interventions have been tried and failed.
How often in your experience do behavioral interventions fail?
What is your estimate of how commonly antipsychotics would be
used if health care professionals were trained in how to
effectively and efficiently deploy a range of behavioral
interventions?
Dr. Evans. Well, as was mentioned earlier in so many words,
if all you have is a hammer, everything looks like a nail. And
that's the problem that we're dealing with now.
As I mentioned in my testimony, I don't use these drugs to
treat behavior. These drugs, study after study has shown, are
ineffective in treating behavior, and I believe that if
appropriate steps were taken, or even if they weren't taken,
that the use of these medications could be reduced to pretty
close to zero in a variety of settings. That being said,
because only a small proportion of the use of these medications
happens in nursing homes, it may not have the huge impact that
you're hoping for.
Eight billion dollars is spent on the off label use of
these drugs currently per year, and based on the OIG's report,
less than a fourth of that is in nursing homes.
The Chairman. So, what is your answer? Maybe you've given
it, but I'd like to hear----
Dr. Evans. My answer is close to zero.
The Chairman. Zero.
Dr. Evans. Yes. In my personal practice it's zero. And
other doctors will give you a different number. But there are
so many other things that can be done that this really does not
represent good dementia care.
The Chairman. Thank you.
Mr. Hlavacek, Mr. Petersen's tragic death seemed to a
wakeup call for the need to find better ways to provide care
for individuals with dementia. How's the Alzheimer's community
in Wisconsin promoting education and training programs
throughout our State so we can prevent others from suffering
the same misfortune? And how can we here in Washington help to
promote these training programs?
Mr. Hlavacek. There are several answers to your question,
Senator. We have two national programs, the Foundation of
Dementia Care, which is the sort of classroom approach for
direct care staff and supervisors, and we have the Online CARES
program, which has a number of modules that are designed to
train on a number of different facets of quality care. And the
person from LeadingAge was absolutely correct. This is a
problem that's in the middle of a bigger set of problems. It's
nested within a number of other problems around quality care.
We certainly believe that staff training and education is
critical. We think it should happen at all levels of the
facility, certainly for the CNAs, as seen in the Affordable
Care Act. But really oftentimes it's the janitor, it's someone
else in the facility that picks up on behaviors earlier and
says, something's wrong with that gentleman down in that
hallway; we should check this out, and not wait for the problem
to take place further. On our chapter level, we have a 16-hour
dementia care specialist training, which is highly in demand
across Wisconsin.
In many of these cases, we see, through the application of
these training programs, that staff have a wakeup call, and
they have new tools beyond just the hammer and the nail to
address some of these difficult issues.
A further problem, though, just to complicate this a little
bit, is staff turnover in these facilities, which is very, very
rampant. You can go back to the same facility that you trained
in a year later, and see a whole sea of fresh faces that
weren't there before because of staff turnover. So, we don't
really value these positions and these jobs too highly in our
society. We need to perhaps look at that as why aren't we
providing a better standard of living for the people working in
the facilities.
The Chairman. Thank you very much, Mr. Hlavacek.
Ms. Edelman, what type of staff training would you
recommend that CMS require to help curb the over utilization of
antipsychotics in nursing homes? And should similar training be
provided also in assisted living facilities, hospitals, as well
as other health care settings?
Ms. Edelman. Training would be extremely important. We
could use the model that we had with physical restraints when
the Nursing Home Reform Law was first implemented in 1990. CMS
did a lot of training about how to remove physical restraints.
It was in-person surveyor training that I attended.
Now CMS does a lot of training with satellite broadcasts.
It can do that. It can send out the word, train all kinds of
people all over the country in better care practices.
One of the organizations that I've been working with very
closely on the antipsychotic drug issue, the California
Advocates for Nursing Home Reform, is conducting a series of
trainings in the State. They had one a week or so ago, with
several hundred nursing home staff members. And they are having
people who have done what Dr. Evans described providing care to
residents with dementia without chemical restraints, and having
people who've done it teach other facilities how to do it. It's
very effective. It definitely worked with physical restraints,
and it should work with chemical restraints as well.
The Chairman. That's good. Thank you.
Dr. Phillips, are hospitals and nursing homes working
together to reduce the rate of antipsychotic use? And if
they're not, will LeadingAge commit to helping to make this
happen?
Dr. Phillips. The short answer is no, and that's
unfortunate. There is a chasm between hospitals and nursing
homes in a variety of problems, and I think the appropriate
care of dementia is but one of them.
The opportunity, certainly through some of the new models
of integrated care provisions, is an excellent starting point.
It will take more than LeadingAge alone, and that's why we're
working so closely with collaborators such as Advancing
Excellence, because we recognize that as we provide that basis
of both learned--let's learn from people who are doing it well
and how to replicate it, but also to inform the clinicians
across the continuum that there are valid and real
alternatives.
Lastly, I want to put in an important issue. We talked
about staff turnover with the Alzheimer's Association. One
thing that Advancing Excellence has identified is when you have
consistent staffing, so that the same person as often as
possible taking care of that same resident. The behavior issues
also tend to decline.
So, that's another area that with--we at LeadingAge,
working with Advancing Excellence, are working on better
understanding, both staff turnover, but also staff consistency,
as probably a key quality measure. And that relates to falls
and certainly to behavior management and persons with dementia.
The Chairman. Dr. Evans, you talked about informed consent.
Dr. Evans. Yes, sir.
The Chairman. Do you believe that the family members of
dementia patients understand that off label use of typical
antipsychotic drugs can be quite harmful? And if not, what can
we do to ensure that family members understand the risks of
these drugs for their loved ones who cannot communicate their
needs clearly, and who are thought to have behavior problems?
Dr. Evans. Sir, the process of informed consent very seldom
occurs in prescription and administration of these medications
in any setting when treating behavior. Part of the reason for
that is that the use of these medications very often represents
a great deal of frustration and caregiver stress, whether it's
in the hospital or nursing home or elsewhere.
And there's a sort of a fantasy really that if somehow
there were just a magic pill that would make it go away, that
all would be well. And so, oftentimes these drugs are initiated
in kind of a crisis situation where it's considered by the
people involved to be urgent, and, therefore, oftentimes family
members aren't notified.
I think that in that particular situation, really what's
going on is these medicines and others like them, other classes
of drugs that Dr. Phillips talked about, are really being used
as tranquilizers.
And, you know, there really aren't diseases that I know of
that only occur on one shift, or on Saturdays only, or, you
know, between--when they're giving report at the hospital or
something like that. The pattern under which these crises
develop often are related to other things going on in the
environment.
And, frankly, I think of this problem that we're talking
about the same way that I think about asbestos. It's been used
everywhere based on what maybe at one time seemed like a good
idea. But now we know it's harmful, and we have to get rid of
it. And it's a rather expensive proposition.
But informed consent at least includes patients and
families in the discussion. I mean, it's one of the fundamental
basis, and certainly one of the most basic ethical principles
about care in this country, and autonomy. And so, you know, I
really can't defend not getting patients' permission to be
provided treatment. Certainly we wouldn't stand for that if it
was a surgery, but the risks that we're talking about are of
comparable magnitude.
You know, having informed consent as part of the process in
some ways allows for a little bit of a cooling off period as
well in that those conversations should happen in the light of
day. But, you know, I think that the reality is that what's
easy and convenient is what gets done. And substantial and
enduring change requires changing what's easy and convenient.
The Chairman. Thank you.
Dr. Evans. Yes, sir.
The Chairman. Ms. Edelman, your testimony notes that 40
percent of nursing home residents are considered to be at high
risk of receiving an atypical antipsychotic drug due to
behavioral problems, which, of course, is an astonishingly high
number. Is there evidence that behavior problems have somehow
become worse over time?
Ms. Edelman. I don't know that we have any evidence that
behavior problems have gotten worse. Residents have behavior
issues, and there's not staff that know the residents and knows
how to deal with them. There's general recognition that nursing
homes are under staffed, and so they're not dealing with
problems as well as they might.
Nursing homes maybe do have residents who are more
seriously ill than before. We do have a whole new alternative
of assisted living now where some people with lesser problems
may be living, although they're beginning to look more and more
like nursing home residents all the time, and I've seen some
reports indicating that they take more drugs than nursing home
residents. So, it's hard to say.
There are behavior issues that people have, and they're not
being dealt with properly. That's probably the primary concern.
The Chairman. Dr. Phillips, you want to comment?
Dr. Phillips. Well, I'll add that just from the clinical
history of dementia, usually the behaviors, when they are
problematic, are phasic. So, early on in the disease process,
not so much. Somewhere in the middle phase, and not for
everyone, and usually by outside--what I mean outside to the
person triggering event, either too much noise, or fatigue, or
pain, or other medical problems, something that creates an
agitation.
But quite frequently, in fact, most commonly in advanced
dementia, the behaviors fade away, if not disappear entirely.
So, even if one argued that occasionally the medications are
appropriate for short-term use, another piece to this problem
is it's like barnacles. Once people are on these medicines,
they don't come off. They tend to just stay on, and they move
from setting to setting with these medicines as part of their
package, if you will.
So, when we think of dementia it's not just that behaviors
get worse over time. In fact, they may be worse somewhere in
the middle of the person's clinical course with dementia. But
not everyone with dementia has difficult behaviors, and
certainly the vast majority of difficult behaviors are
triggered and, therefore, resolved by outside environmental
issues that can be much better addressed through intervention
rather than pills.
The Chairman. Dr. Phillips, are there safer medications
than antipsychotics for individuals with dementia who are in
pain? And if so, what are they?
Dr. Phillips. Well, to address specifically pain, we have
another issue in the nursing home that I know you're very
familiar with, and that is the appropriate treatment of pain
for nursing home residents. It has been noted by several
studies that even the use of medications, like morphine, when
people are in pain, their confusion gets better if their
confusion was due to untreated pain.
What I'm cautious about and I had mentioned earlier in
unintended consequences, is we don't substitute antipsychotics
for other inappropriate drugs. But having said that, sometimes
the very best management for a person who's acutely agitated
who cannot give us their story through words is to look and
see, is pain the underlying problem, and treat with pain.
In fact, some nursing homes have now routinely looked at
low dose of medicines, like acetaminophen, to use in persons
with dementia who have risk for pain to see if that doesn't,
rather than waiting for their behaviors to escalate, if that
doesn't modulate some of the agitation underline.
Now, I'm certainly not purporting that we just give
medicines willy nilly to everybody without being very careful
about what is the appropriate indication for any medicine,
including pain medicines. But part of one piece to this problem
is that when we don't appropriately treat pain, we see it
resultant in increased agitation and what we label as difficult
behaviors in persons with dementia.
The Chairman. Ms. Edelman.
Ms. Edelman. May I say something? The researcher that I
talked about at the end of my testimony in New York has done
work, and I will try to get a copy of this and submit it for
the record. She's looked at residents who have dementia and
whether they get as much pain medication as residents without
dementia with the same physical diagnoses, the same medical
problems. And she has found that they don't get as much pain
medication as non-dementia residents get. So, that's a very
strong indication that a lot of the problem is that people are
in pain, and it's not being treated properly because it hasn't
been identified.
Now, CMS is trying to fix that. The new assessment process,
MDS 3.0, which has now been in place for about a year--a little
over a year--has changed the way facilities assess residents'
pain. In the past, the staff wrote down whether they thought
residents were in pain. Now, the staff is asking residents if
they're in pain.
And the numbers should really be considerably higher than
we've seen before because most people think that maybe 50, 60
percent, 70 percent of residents have some pain problem. So, if
that gets identified and treated, there might be--yes, this
could really be a very important way of getting around all this
antipsychotic drug use, because the residents are in pain and
it's not being identified and treated.
The Chairman. Yes, please submit it to us.
Mr. Hlavacek, any comments you wish to make to this panel?
Mr. Hlavacek. Once again, thank you so much for holding
this hearing. One of the things that was touched upon was the
whole concept of care transitions, and I think that that's a
very important piece for the committee to consider going into
the future. We have definitely seen a breakdown in
communications in our task force between the hospitals and the
nursing homes and assisted living facilities. People get
transferred out of a facility and into a hospital. The bed may
close behind the hospital. The hospital may have a really
difficult time getting the person placed back someplace in the
community that's appropriate.
And the hospital, on the other hand, may say, you know, we
send them back to the facility and they show up back here again
in a few days, and we can't have that happen because of the
Medicare readmission rules.
So, I think that looking at those care transitions in light
of this particular issue, would be very informative because of
the fact that our experience is that is one place where the use
of those medications can truly escalate.
We've heard nursing homes say they come back from the
hospital and they're on more medications than we know what to
do with. And we've heard hospitals say when they come here,
they're on 12 different medications; how does the nursing home
allow that to happen?
So, it's a complex issue, but I think that there's a lot of
room for both hospitals, and nursing homes, and long-term care
facilities, and including assisted living, to have a strong
vested self-interest in fixing that problem. It doesn't work
for anybody. And so, I think that that would be a great idea
for further development of policy, and collaborations, and best
practice models.
The Chairman. That's a good comment. Thank you.
Anybody else like to add to this very informative
discussion? Dr. Evans?
Dr. Evans. If I could just add that, you know, we have a
huge problem in this country with extraordinarily expensive
care and significant concerns about health care quality such
that we're not getting our money's worth. Doctors
unfortunately, as this hearing has described, have a large
share of responsibility for many of the problems that exist in
health care, particularly with regard to prescribing
medications. And I believe that doctors have a responsibility
to be part of the solution. And my colleagues and I are very
committed to solving this problem.
I also would just like to say that good care really
shouldn't depend in this country on where you go to get it.
People should have a reasonable expectation of good care
anywhere and everywhere, whether it's a hospital, a nursing
home, an office.
And so, it's my hope that in my lifetime that I will see
the standard of care being applied really equally across all
care settings, and things that have been shown to be successful
and effective in one setting apply to other settings.
The Chairman. Thank you, Dr. Evans.
Ms. Edelman.
Ms. Edelman. Yes. As important as training is, it is
important for facilities to be trained and prescribers to be
trained. It's also important that CMS strengthen a little bit
the very excellent regulations that already has and the
guidelines, but that it put some additional attention on the
issue of antipsychotic drug use. If each survey made sure to
include in the resident sample, resident with antipsychotic
drugs, really focus attention on this issue, it would be very
helpful.
And if the enforcement could be strengthened. I've read a
couple of decisions from the administrative law judges where
unnecessary drugs, antipsychotic drugs, have been cited, but
the civil money penalty was $300 a day. A $3,900 penalty for
over medicating a resident seems like a very inadequate
penalty.
And, finally, I think there are a couple of laws and
regulations that could help strengthen oversight of
antipsychotic drug use. What we have is a very excellent base
of law and regulation. Section 7 of the Prescription Drug Cost
Reduction Act that you introduced last month would require
physician certification that the off label prescription of an
antipsychotic drug is for medically accepted indications. That
would be very important. We would really hope that that would
get enacted.
CMS recently proposed amending the consultant pharmacist
regulations to make sure that they are independent. That's very
important. Independent consultant pharmacists can make an
enormous difference, and really call to the physician's
attention that there's a problem with the prescribing of the
drugs. And the physicians are required to respond to the
irregularities. Not that they have to keep records, but they
are required to respond.
And finally, in 1992, CMS proposed very comprehensive
regulations on chemical restraints, which would strengthen the
requirements on informed consent. Those regulations have never
been issued in final form, and we would encourage CMS to do
that as well.
The Chairman. Thank you.
Thank you all very much for being here. This is obviously a
very important issue, and you did shine a lot of light as we
move forward to improve. Thank you so much.
[Whereupon, at 3:39 p.m., the hearing was adjourned.]
APPENDIX