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72–764 PDF 2012

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 

(II) 

SPECIAL COMMITTEE ON AGING 

HERB KOHL, Wisconsin, Chairman 

RON WYDEN, Oregon 

BILL NELSON, Florida 

BOB CASEY, Pennsylvania 

CLAIRE MCCASKILL, Missouri 

SHELDON WHITEHOUSE, Rhode Island 

MARK UDALL, Colorado 

MICHAEL BENNET, Colorado 

KRISTEN GILLIBRAND, New York 

JOE MANCHIN III, West Virginia 

RICHARD BLUMENTHAL, Connecticut 

BOB CORKER, Tennessee 

SUSAN COLLINS, Maine 

ORRIN HATCH, Utah 

MARK KIRK III, Illnois 

DEAN HELLER, Nevada 

JERRY MORAN, Kansas 

RONALD H. JOHNSON, Wisconsin 

RICHARD SHELBY, Alabama 

LINDSEY GRAHAM, South Carolina 

SAXBY CHAMBLISS, Georgia 

DEBRA WHITMAN, Majority Staff Director 

MICHAEL BASSETT, Ranking Member Staff Director 

(III) 

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 

Page

IV 

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 

(1) 

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, 

2 

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 

3 

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 improveVerDate Nov 24 2008 15:13 Mar 19, 2012 Jkt 072764 PO 00000 Frm 00007 Fmt 6633 Sfmt 6633 C:\DOCS\72764.TXT DPROCT
4 

ment, 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 nonpharmacologic 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 longterm 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. 

5 

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 

6 

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 nonpharmacologic 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? 

7 

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. 

8 

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. 

9 

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 responsiVerDate Nov 24 2008 15:13 Mar 19, 2012 Jkt 072764 PO 00000 Frm 00013 Fmt 6633 Sfmt 6633 C:\DOCS\72764.TXT DPROCT
10 

bility 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 

11 

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? 

12 

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. 

13 

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, 

14 

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, whethVerDate Nov 24 2008 15:13 Mar 19, 2012 Jkt 072764 PO 00000 Frm 00018 Fmt 6633 Sfmt 6633 C:\DOCS\72764.TXT DPROCT
15 

er 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 longterm 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, 

16 

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 dediVerDate Nov 24 2008 15:13 Mar 19, 2012 Jkt 072764 PO 00000 Frm 00020 Fmt 6633 Sfmt 6633 C:\DOCS\72764.TXT DPROCT
17 

cated 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 perVerDate Nov 24 2008 15:13 Mar 19, 2012 Jkt 072764 PO 00000 Frm 00021 Fmt 6633 Sfmt 6633 C:\DOCS\72764.TXT DPROCT
18 

spectives 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. 

19 

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 

20 

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 nonpharmacological 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. 

21 

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 longterm 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. 

22 

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 personcentered 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 notfor-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. 

23 

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? 

24 

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 inperson 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. 

25 

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. 

26 

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 

27 

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 nondementia 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 

28 

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 

29 

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.] 

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