[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

=======================================================================

                                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








         Available via the World Wide Web: http://www.fdsys.gov



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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
                              ----------                              
                 Debra Whitman, Majority Staff Director
             Michael Bassett, Ranking Member Staff Director












                                CONTENTS

                              ----------                              

                                                                   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

                              ----------                              


                      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






                                  
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