[House Hearing, 108 Congress]
[From the U.S. Government Publishing Office]



PRESCRIPTION DRUG MONITORING: STRATEGIES TO PROMOTE TREATMENT AND DETER 
                         PRESCRIPTION DRUG USE

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

                                HEARING

                               before the

                         SUBCOMMITTEE ON HEALTH

                                 of the

                    COMMITTEE ON ENERGY AND COMMERCE
                        HOUSE OF REPRESENTATIVES

                      ONE HUNDRED EIGHTH CONGRESS

                             SECOND SESSION

                               __________

                             MARCH 4, 2004

                               __________

                           Serial No. 108-73

                               __________

       Printed for the use of the Committee on Energy and Commerce


 Available via the World Wide Web: http://www.access.gpo.gov/congress/
                                 house



                               __________

92-538              U.S. GOVERNMENT PRINTING OFFICE
                            WASHINGTON : 2003
____________________________________________________________________________
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                    ------------------------------  

                    COMMITTEE ON ENERGY AND COMMERCE

                      JOE BARTON, Texas, Chairman

W.J. ``BILLY'' TAUZIN, Louisiana     JOHN D. DINGELL, Michigan
RALPH M. HALL, Texas                   Ranking Member
MICHAEL BILIRAKIS, Florida           HENRY A. WAXMAN, California
FRED UPTON, Michigan                 EDWARD J. MARKEY, Massachusetts
CLIFF STEARNS, Florida               RICK BOUCHER, Virginia
PAUL E. GILLMOR, Ohio                EDOLPHUS TOWNS, New York
JAMES C. GREENWOOD, Pennsylvania     FRANK PALLONE, Jr., New Jersey
CHRISTOPHER COX, California          SHERROD BROWN, Ohio
NATHAN DEAL, Georgia                 BART GORDON, Tennessee
RICHARD BURR, North Carolina         PETER DEUTSCH, Florida
ED WHITFIELD, Kentucky               BOBBY L. RUSH, Illinois
CHARLIE NORWOOD, Georgia             ANNA G. ESHOO, California
BARBARA CUBIN, Wyoming               BART STUPAK, Michigan
JOHN SHIMKUS, Illinois               ELIOT L. ENGEL, New York
HEATHER WILSON, New Mexico           ALBERT R. WYNN, Maryland
JOHN B. SHADEGG, Arizona             GENE GREEN, Texas
CHARLES W. ``CHIP'' PICKERING,       KAREN McCARTHY, Missouri
Mississippi, Vice Chairman           TED STRICKLAND, Ohio
VITO FOSSELLA, New York              DIANA DeGETTE, Colorado
STEVE BUYER, Indiana                 LOIS CAPPS, California
GEORGE RADANOVICH, California        MICHAEL F. DOYLE, Pennsylvania
CHARLES F. BASS, New Hampshire       CHRISTOPHER JOHN, Louisiana
JOSEPH R. PITTS, Pennsylvania        TOM ALLEN, Maine
MARY BONO, California                JIM DAVIS, Florida
GREG WALDEN, Oregon                  JANICE D. SCHAKOWSKY, Illinois
LEE TERRY, Nebraska                  HILDA L. SOLIS, California
MIKE FERGUSON, New Jersey            CHARLES A. GONZALEZ, Texas
MIKE ROGERS, Michigan
DARRELL E. ISSA, California
C.L. ``BUTCH'' OTTER, Idaho
JOHN SULLIVAN, Oklahoma

                      Bud Albright, Staff Director

                   James D. Barnette, General Counsel

      Reid P.F. Stuntz, Minority Staff Director and Chief Counsel

                                 ______

                         Subcommittee on Health

                  MICHAEL BILIRAKIS, Florida, Chairman

RALPH M. HALL, Texas                 SHERROD BROWN, Ohio
FRED UPTON, Michigan                   Ranking Member
JAMES C. GREENWOOD, Pennsylvania     HENRY A. WAXMAN, California
NATHAN DEAL, Georgia                 EDOLPHUS TOWNS, New York
RICHARD BURR, North Carolina         FRANK PALLONE, Jr., New Jersey
ED WHITFIELD, Kentucky               BART GORDON, Tennessee
CHARLIE NORWOOD, Georgia             ANNA G. ESHOO, California
  Vice Chairman                      BART STUPAK, Michigan
BARBARA CUBIN, Wyoming               ELIOT L. ENGEL, New York
JOHN SHIMKUS, Illinois               GENE GREEN, Texas
HEATHER WILSON, New Mexico           TED STRICKLAND, Ohio
JOHN B. SHADEGG, Arizona             DIANA DeGETTE, Colorado
CHARLES W. ``CHIP'' PICKERING,       LOIS CAPPS, California
Mississippi                          CHRIS JOHN, Louisiana
STEVE BUYER, Indiana                 BOBBY L. RUSH, Illinois
JOSEPH R. PITTS, Pennsylvania        JOHN D. DINGELL, Michigan,
MIKE FERGUSON, New Jersey              (Ex Officio)
MIKE ROGERS, Michigan
JOE BARTON, Texas,
  (Ex Officio)

                                  (ii)




                            C O N T E N T S

                               __________
                                                                   Page

Testimony of:
Crosse, Marcia, Health Care, Public Health and Military Health 
  Care Issues, U.S. General Accounting Office....................    23
Droz, Danna E., Executive Director, Boards of Pharmacy and 
  Nursing Home Administrators....................................    30
Holsinger, James W., Jr., Secretary, Kentucky Cabinet for Health 
  and Family Services............................................    36
Manchikanti, Laximaiah, American Society of Preventional Pain 
  Physicians.....................................................    39
Rogers, Hon. Harold, a Representative in Congress from the State 
  of Kentucky....................................................    12

                                 (iii)

  

 
PRESCRIPTION DRUG MONITORING: STRATEGIES TO PROMOTE TREATMENT AND DETER 
                         PRESCRIPTION DRUG USE

                              ----------                              


                        THURSDAY, MARCH 4, 2004

                  House of Representatives,
                  Committee on Energy and Commerce,
                                    Subcommittee on Health,
                                                    Washington, DC.
    The subcommittee met, pursuant to notice, at 1 p.m., in 
room 2123, Rayburn House Office Building, Hon. Michael 
Bilirakis (chairman) presiding.
    Members present: Representatives Bilirakis, Greenwood, 
Whitfield, Norwood, Shimkus, Wilson, Buyer, Ferguson, Brown, 
Pallone, Stupak, Green, Strickland, and Capps.
    Staff present: Patrick Morrisey, deputy staff director; 
Jeremy Allen, health policy coordinator; Cheryl Jaeger, 
majority professional staff; Eugenia Edwards, legislative 
clerk; and John Ford, minority counsel.
    Mr. Norwood [presiding]. The subcommittee will now come to 
order. First I want to, and I will do so formally in a minute, 
but I want to thank our witnesses for being here. Congressman 
Rogers will be here shortly, and will testify and be questioned 
first, and then we'll go to the other panel.
    I'll recognize myself now for an opening statement.
    First, good afternoon to everyone. This, for me, is a very 
exciting hearing. I'm looking forward to it. There's so much to 
do and so much we need to learn, but I want to first thank all 
of you for attending and being part of this today.
    As our witnesses are going to testify today, the need for 
legislation to curb prescription drug abuse is very obvious. 
It's been obvious to me in my life for about 30 years.
    In 2002, the Office of National Drug Control Policy 
reported that 6.2 million Americans abused prescription drugs, 
that's 6.2 million. 13.7 percent of youth between the ages of 
12 and 17 have abused prescription drugs at least once in their 
lifetimes, and emergency room visits resulting from narcotic 
pain relievers abuse has increased 163 percent since 1995.
    On Monday, the White House announced the President's 
strategy for combating prescription drug abuse in an event that 
included the heads of DEA, FDA, the Drug Czar and the chairman 
of a committee that doesn't have jurisdiction over this issue. 
They highlighted the need for expanding prescription drug 
monitoring programs.
    Twenty one States currently operate from some form of 
prescription drug monitoring program. Maybe it's less, but the 
President indicated 21 yesterday, but we know it's somewhere 
between 21 and 15.
    The President would like to see this number expanded, and 
certainly we should consider ways to meet that goal.
    Mr. Chairman, welcome.
    As we consider how to expand these programs, there are 
several issues we need to consider in the design of these 
programs. Should they be State-based or federally centralized? 
Should they be run out of HHS or DEA? Who should be able to 
access the data base?
    A State like Nevada allows very little access to their data 
base, while Kentucky has numerous people allowed access.
    What schedule of drugs should be covered under a monitoring 
program? What can we do to protect patient confidentiality, 
because if we can't be confident that we are protecting patient 
confidentiality we might not be able to do this.
    We also need to be very certain we aren't increasing the 
liability of anyone through the establishment of monitoring 
programs.
    I look very forward to our witnesses addressing these 
issues today. The use of drugs to relieve pain is a subject 
with which I have had significant experience over my life. I 
experienced it when I was in Vietnam. I've experienced it in my 
practice as a dentist for 25 years. I experienced it with my 
friends and family through difficulties they faced in life. 
I've experienced it personally after a car wreck in 2000. I 
feel very strongly that we don't do a good enough job in this 
country to alleviate pain when we can, and morally and 
ethically we should.
    I also know that the drugs that relieve the most severe 
pain are also usually the most dangerous. The value of drugs in 
relieving pain may be a double-edged sword, because drugs can 
create a dependency that makes it difficult for sufferers to 
wean themselves off these painkillers. And, these painkilling 
drugs also can be diverted for recreational use by abusers.
    This is why we have the Controlled Substance Act. We hold 
certain drugs to a higher regulatory standard, because we are 
concerned about how they might be abused. We are faced with a 
difficult and a complicated task in combating prescription drug 
abuse. We must be careful that our efforts to stop abuse don't 
forbid legitimate patients from getting the relief that they 
need when they need it.
    If we come up with solutions that discourage doctors from 
prescribing appropriate painkillers, pain care in this country 
will take a serious step backward.
    I'd like to close by, again, welcoming all of our 
witnesses. Chairman Rogers, who has been a pioneer in this 
field, and, Mr. Chairman, I'm grateful for the work you've 
done, and I apologize to you that people like me, who are so 
familiar with this problem, hadn't done something before now. 
But, thank you for what you've done.
    Marcia, Ms. Crosse, of the GAO, who is going to speak to 
their Report on Monitoring Programs. Danna Droz, did I say that 
right, Droz, of the great State of Florida, way to go, girl, 
who is here representing the National Association of State 
Controlled Substance Authorities. James Holsinger, who runs 
Kentucky's NASPER program, and Doctor Laximaiah Manchikanti, 
how did I do, got it better, huh, a doctor who understands and 
has done great work in the treatment and complexities of 
treating patients in severe pain.
    Again, I sincerely thank all of you that are here. We will 
give the members an opportunity to make an opening statement. I 
remind the members, your opening statement is 5 minutes. If you 
wish to waive your opening statement, we'll add 3 minutes to 
your questioning time, and with that I yield to my friend, Mr. 
Brown, the ranking minority member of this committee.
    Mr. Brown. Thank you, Mr. Chairman. I want to welcome 
Doctor Manchikanti and all the distinguished witnesses that 
have joined us today.
    Prescription pain relievers, stimulants and other 
controlled substances, as we know, play a crucial role in our 
healthcare. When misused, these same medicines can be 
enormously disruptive. Some are addictive, some are life-
threatening, many are both.
    As these medicines proliferate, so, unfortunately, does the 
risk of misuse. Over the last decade, use of prescription pain 
relievers has increased by about 200 percent, while the use of 
stimulants has increased by about 150 percent. 6.2 million 
Americans misuse prescription medications for non-medical 
purposes.
    In 1999, a quarter of those who took prescription drugs for 
non-medical purposes were new users. In other words, this 
problem isn't just growing, it's exploding. Nearly 10 percent 
of the individuals in drug treatment today are there, not 
because of a cocaine habit, not because of a heroin habit, not 
because of a crack habit, they are there to break free of a 
prescription drug habit.
    Physicians and pharmacists too often play an unwitting role 
in the misuse of prescription drugs. By receiving prescriptions 
for more than one practitioner, filling these prescriptions in 
pharmacies unaffiliated with one another, patients can 
stockpile and mix controlled substances, in which case the 
whole notion of controlled substance simply loses its meaning.
    It's a tragically easy route to drug abuse for vulnerable 
adolescents and adults. It's an untenable situation for health 
professionals, whose mission it is to help patients heal. To 
combat this problem, physicians and pharmacists need 
information. Fifteen States have implemented drug registries 
that track the prescribing of certain controlled substances. 
Two other States are in the process of doing that.
    The GAO has studied drug registries and have reinforced the 
usefulness of these monitoring mechanisms.
    This hearing is intended to equip members with the 
background that we all need as we prepare to consider various 
legislative proposals intended to expand access to drug 
registries.
    I thank you, Chairman, for giving members the opportunity. 
I look forward to hearing from all of our witnesses.
    Mr. Norwood. Thank you, Mr. Brown.
    I'd like to recognize my good friend from Kentucky, Mr. 
Whitfield, who all of us need to thank and congratulate for the 
work that he has been doing in this particular area of 
monitoring prescription drugs.
    Ed, you are recognized for 5 minutes.
    Mr. Whitfield. Mr. Chairman, thank you very much for having 
this hearing, and the issue of prescription drug abuse is a 
national issue, and is a matter of public health, one of which 
this committee has jurisdiction, and unless my memory fails me, 
this may be the first hearing that we've had on prescription 
drug monitoring programs, which is certainly a very important 
program.
    I was also, like you, Mr. Chairman, pleased to note that 
President Bush's recent commitment to curbing prescription drug 
abuse, through the Office of National Drug Control Policy.
    We do have a distinguished panel here today, including our 
colleague, Hal Rogers, who is the Dean of the Kentucky 
Delegation. He's worked hard to address the problem of 
prescription drug abuse, specifically, OxyContin, which is 
prevalent in this district, and has established a program of 
grants available to States.
    I'm also pleased to welcome Doctor James Holsinger, who is 
the Secretary of the Kentucky Cabinet for Health and Family 
Services. The Secretary was appointed to his position by our 
former colleague and member of this committee, Doctor Ernie 
Fletcher, and I look forward certainly to hearing his testimony 
as well, Secretary Holsinger's.
    I'm also pleased to welcome Doctor Laximaiah Manchikanti, 
who is President of the American Society of Interventional Pain 
Physicians. As a physician, he will give us some insight into 
how physicians are working to identify and treat patients who 
are addicted to prescription drugs.
    When we talk about prescription drug abuse, we are talking 
about individuals who are using controlled substances in a 
manner that is inconsistent with their prescribed use. The 
Federal Government exercises its authority in this area through 
the Controlled Substances Act of 1970. The Act, of course, 
classifies drugs into five schedules, based mainly on their 
potential for abuse.
    Although Schedule 1 drugs, such as heroin, are not legally 
available, Schedule 2 through 5 drugs are. However, the 
production and distribution of these drugs, such as OxyContin, 
are regulated by the Drug Enforcement Administration.
    I recognize that many people live with chronic pain, or 
have pain as a direct result of a disease, such as cancer, and 
know that in many cases relief from their pain comes only from 
a controlled substance. It is important that these individuals 
continue to have access to these drugs.
    Unfortunately, some people who are prescribed a controlled 
substance to relieve pain, either on a long or short-term 
basis, become addicted to them, and many individuals who have 
not been prescribed these drugs illegally obtain them as an 
alternative to other drugs.
    So, we are all familiar with the problem of prescription 
drug abuse, but the issue becomes how do we help prevent abuse? 
And, I believe, along with everyone else in this room, that one 
way we can effectively combat this problem is through enhancing 
prescription drug monitoring programs.
    Many States, including my own State of Kentucky, have 
prescription drug monitoring programs, and many people would 
say that the Kentucky program, which I might add was 
established by the Dean of our Delegation, Hal Rogers, many 
people say it is the most effective program in the state. And 
so, I think we are all very proud of that.
    But, today's hearing, I think, is important because we need 
to determine where do we move in the future. You can make a 
strong argument that there should be a strong Federal program, 
because of the Controlled Substance Act, because of DEA, 
because of Medicaid that the Federal Government is involved in 
distributing medicines, because of the new Prescription Drug 
Benefit Program under Medicare. And, some of us on this 
committee have actually introduced legislation to do that.
    Where, on the other hand, we recognize that there are many 
people, and we'll hear some testimony today about this, who 
believe that the most effective way to deal with it is through 
a State program, and both of them have their weaknesses, and 
not any program in existence today is doing everything that 
needs to be done. For example, the State programs deal only 
with intra State issues, and so there's an inner connectivity 
problem for patients who go back and forth across States, and 
maybe one State does not have a program.
    So, those are some of the issues that I know we'll be 
getting into today, and I'm delighted with our witnesses that 
we have, experts in the field, and all of us will walk away 
from this hearing better informed than we are now, and I'll 
yield back my 1 second.
    Mr. Norwood. Thank you very much, Mr. Whitfield, and thank 
you for the good work that you do.
    I'd like to remind all my colleagues, if you wish to waive 
your opening statement, you'll pick up 3 minutes on your 
questioning time, and the only reason I'm suggesting that to 
you is that Chairman Rogers does have a homeland security thing 
coming up.
    So, with that, Mr. Pallone, you are now yielded 5 minutes.
    Mr. Pallone. Thank you, Mr. Chairman.
    I wanted to say that I'm pleased to be here today to 
discuss prescription drug monitoring and the various ways that 
Congress can address the ever-increasing problem of 
prescription drug abuse throughout the United States.
    I want to thank all the witnesses for joining us today, to 
provide expertise on how best to tackle widespread addiction 
abuse and illegal marketing of prescription drugs, and 
particularly, I look forward to hearing from my good friend, 
Doctor Laximaiah Manchikanti, who has worked tirelessly on the 
forefront of creating a national prescription drug monitoring 
data base. And, as a result of Doctor Manchikanti's dedication 
to improving public health and his contributions to the medical 
profession, Congressman Whitfield and I introduced legislation, 
known as the NASPER Bill, H.R. 3015, the National all Schedules 
Prescription Electronic Reporting Act, and I, along with the 
bipartisan group of nearly 40 members, who have cosponsored 
this legislation, feel strongly about a national uniform 
approach to addressing prescription drug abuse and crime.
    And, I also wanted to pay special attention to the 
contribution of Congressman Bart Stupak, who is a cosponsor and 
worked very hard on this, and also I think you've included in 
the record, Mr. Chairman, a letter from the American 
Association of Physicians of Indian Origin, which is a group 
that I work with a lot who also support the legislation.
    Everyone here, including the Bush Administration, agrees 
that rampant prescription drug misuse and abuse is a growing 
problem. Millions of Americans who take prescription 
medications take them responsibly. However, reliable data 
indicates there are also 9 million Americans, including 
children, teenagers and seniors, who use prescription drugs for 
non-medical reasons, and this can result from needing various 
multiple medications and thereby make them vulnerable to 
misuse, or can result from illegal sales of prescription drugs 
and prescription forgery.
    The NASPER approach is vitally important to ensuring our 
public health, in my opinion. It would establish a national 
electronic data bank for practitioner monitoring of Schedule 2, 
3 and 4 controlled substances, and allows healthcare 
practitioners and pharmacists to ensure that they are 
prescribing and dispensing only necessary medications.
    Without such a data bank, practitioners and pharmacists 
have no way of knowing with any certainty whether a particular 
patient may be receiving the same or incompatible controlled 
substances from other practitioners. Patients may be receiving 
prescriptions for these medications from multiple 
practitioners, and this is particularly troubling in light of 
the fact that such controlled substances can be the subject of 
abuse, misuse and trafficking, and have the potential for 
dangerous drug interactions.
    I think we can all agree, Mr. Chairman, that the 
unmonitored prescription of these medications poses serious 
public health issues. A number of States, as has been mentioned 
already today, including California, Hawaii, Idaho, Illinois, 
Indiana, Kentucky, Michigan, Nevada, New Mexico, Oklahoma, 
Texas and Utah, have created prescription data banks for 
controlled substances. The State programs, however, are neither 
uniform, nor integrated. Moreover, the misuse of Schedule 2, 3 
and 4 substances is a national problem that cannot be 
effectively addressed, in my opinion, on a State-by-State 
basis.
    And, this proposal, our proposal for a national 
prescription data bank, I think makes good sense from a public 
health perspective, and I look forward to hearing from the 
witnesses and working with my colleagues on this very important 
issue.
    I do want to thank you and the subcommittee, both you, Mr. 
Chairman, and the ranking member, for having this hearing 
today. I think it's very important, and I think it's testimony 
to the fact that you would like to see some kind of legislation 
passed, and, obviously, we are willing to work toward that goal 
on a bipartisan basis.
    Thank you.
    Mr. Norwood. Thank you, Mr. Pallone.
    I can't imagine how we ought to do a bill that isn't 
bipartisan in nature, and I can't imagine how we would want to 
do a bill that we wouldn't have everybody in Congress voting 
for. This is a very important issue and it's not our last 
hearing.
    I'd like to recognize my friend from New Mexico, Ms. 
Wilson, you are recognized for 5 minutes.
    Ms. Wilson. Thank you, Mr. Chairman, and I don't think I'll 
take the full 5 minutes, but I did want to highlight what a 
problem this is, and a growing problem in New Mexico.
    New Mexico, we ended or lost our prescription drug 
monitoring program in 2000, and I read a story that was in the 
newspaper in November, 2003, about a grandmother who was a 
child psychiatrist, and she had arthritis, and one of the side 
effects of her arthritis medicine was depression. So, she 
started to be treated for the depression, and she was taking 
anti-anxiety drugs, Xanax and Halcion, and started to need them 
more and more. She was lying about her need for the them and 
where she got them. She was receiving identical prescriptions 
from a family doctor, a rheumatologist and a psychiatrist. If 
she had a prescription for three a day she'd take nine a day, 
and eventually she realized that the disintegration of her 
life, the loss of her job, the loss of her home, her 
relationships with her grandchildren, disintegration that was 
happening to her was not because of the arthritis and the 
depression, but because of the drugs and the drug addiction.
    She ended up in a detox center for 6 days, and she's now 
getting her life back together, but I think what this really 
tells us is that this can happen, addiction can happen to 
anyone, and I regret that we do have in place the kind of 
prescription drug monitoring program that might have picked up 
the multiple doctors' prescriptions to a single person so that 
this woman could have gotten help.
    In New Mexico, death from overdoses have been slowly and 
steadily increasing. There was 2.7 per 100,000 population in 
1998, and it's now up to 3.8 per 100,000 in 2002. While illegal 
drug use is on the decline, the abuse of legal drugs and 
addiction to legal drugs is on the increase. You see it in our 
poison control center statistics in New Mexico, in our death 
statistics, and in tragic stories of lives lost or destroyed 
because of addiction to prescription drugs.
    I look forward to the testimony here today, and I look 
forward to working with my colleagues and with the 
administration on how we can address this problem so that those 
who need medicine still have access to it, but that we provide 
health, support and recognize the potential problem of 
addiction to those lifesaving and life-changing medicines.
    I thank you, Chairman--Mr. Chairman, for holding this 
hearing today and yield the balance of my time.
    Mr. Norwood. Thank you very much.
    Ms. Capps, you intend to waive your opening statement and 
you'll get 3 minutes of additional time in your questioning.
    I'd like to now welcome our Chairman and offer him time for 
his opening statement.
    Mr. Bilirakis.
    Mr. Bilirakis. Thank you. Thank you, Mr. Chairman.
    Mr. Chairman, I have a statement that I would ask unanimous 
consent it be made part of the record, and would merely just 
want to welcome all of our witnesses, and to commend Mr. 
Whitfield and you for your interest in this subject, and the 
fact that you have supported that interest by virtue of 
offering legislation, and, particularly, our colleague, Mr. 
Rogers, who has been a fighter of this issue for a long, long 
time. And, Hal, I know you've been in the middle of a pretty 
darn important hearing in your own committee that you've 
headed, and I appreciate your taking time to be here, because 
we need to hear from you on the issue.
    Thank you very much, Mr. Chairman. Thanks for being here on 
time, but between a Veterans Committee hearing and a very 
important Veterans Special that I had to do on the floor.
    [The prepared statement of Hon. Michael Bilirakis follows:]

Prepared Statement of Hon. Michael Bilirakis, Chairman, Subcommittee on 
                                 Health

    Good afternoon. Today's Health Subcommittee hearing, entitled 
``Prescription Drug Monitoring: Strategies to Promote Treatment and 
Deter Prescription Drug Abuse,'' focuses on an issue that is extremely 
important to this country's overall health and well-being. I thank you 
all for coming here today.
    Prescription drug abuse is an issue that many Members of the Energy 
and Commerce Committee have been greatly concerned about, and is also 
receiving national attention as well. President Bush recently included 
a plan to increase the number of state prescription drug monitoring 
programs in his National Drug Control Strategy.
    In recent years, the misuse and abuse of prescription medications 
that are classified as schedule II, III, and IV controlled substances 
has become a major national concern. A 2001 Drug Enforcement 
Investigation (DEA) investigation into the abuse of the pain medicine 
OxyContin found that many drug abusers and dealers illegally obtain 
prescription drugs by ``doctor shopping,'' a practice whereby they 
visit a number of physicians in an attempt to maximize the number of 
drugs they can obtain. Additionally, drug abusers and dealers have 
illegally obtained prescription drugs from physicians or pharmacists, 
forged prescriptions, and purchased drugs from Internet pharmacies 
without a valid prescription.
    Prescription drugs that are classified as schedule II, III, and IV 
are primarily pain-related drugs. These drugs are an important source 
of treatment for many Americans; however, by nature of their 
composition, they have the potential for serious abuse. One strategy 
states have adopted in their attempts to deal with this crisis is the 
implementation of prescription drug monitoring programs. Currently, 22 
states have such programs, and many additional states are considering 
implementing systems.
    We have an excellent panel of witnesses here today that will help 
Subcommittee members learn more about the problem and what differing 
notions exist about the proper role of the federal government is in 
enabling the growth of these prescription drug monitoring programs.
    First, I would like to thank our colleague, Congressman Hal Rogers, 
for taking the time to share his personal experiences with OxyContin 
abuse in his state of Kentucky with us. Your insight will prove 
valuable as the Subcommittee moves forward with its work in this area.
    I would also like to thank our other witnesses for being here 
today. Ms. Marcia Crosse, the Director of Health Care for Public Health 
and Military Health Care Issues at the General Accounting Office is 
here today to discuss GAO's studies into prescription drug monitoring 
programs, and how they have helped reduce the illegal diversion of 
drugs.
    Ms. Danna Droz, who recently became the Executive Director of the 
Boards of Pharmacy and Nursing Home Administrators in my home state of 
Florida, is testifying before us today to present the views of the 
National Association of State Controlled Substance Authorities.
    Dr. James W. Holsinger, Jr., Secretary of the Kentucky Cabinet for 
Health and Family Services will share his state's experience with the 
Kentucky All Schedule Prescription Electronic Reporting program 
(KASPER). I look forward to hearing about Kentucky's program.
    Finally, Dr. Laximaiah Manchikanti, will be representing the 
American Society of International Pain Physicians, and will discuss his 
organizations views on prescription drug monitoring systems.
    Thank you again for taking the time to join us today. I would now 
recognize the ranking member, my friend from Ohio Mr. Brown, for an 
opening statement.

    Mr. Norwood. I was watching you.
    Mr. Bilirakis. Oh, were you?
    Mr. Norwood. Mr. Green, you are now recognized for 5 
minutes.
    Mr. Green. Thank you, Mr. Chairman, and I will not take the 
full 5 minutes, because I know I want to hear from our panel 
and also Chairman Rogers, and I'll submit my statement for the 
record.
    I appreciate the opportunity to have this panel and also 
this hearing on the abuse of prescription drugs. I don't think 
that with what's in the news, whether it be, you know, 
celebrities or anyone else, it's a problem and I appreciate you 
calling this hearing so we can call attention to it.
    Thank you.
    Mr. Norwood. Thank you, Mr. Green.
    Mr. Shimkus, you are recognized for 5 minutes.
    Mr. Shimkus. Thank you, Mr. Chairman.
    My inaugural visit to the Health Subcommittee, I know it's 
going to be a short stay, but I'm glad to be on here for a 
short time.
    I, too, want to welcome Congressman Rogers, a well-
respected member from Kentucky, and we're glad to have you in 
our room, and in our midst.
    I also want to personally welcome Doctor Manchikanti, who 
has practiced in my district in Southern Illinois, and just as 
Doctor Manchikanti can easily venture from Illinois to Kentucky 
to practice medicine, a drug abuser could travel from my 
district to Kentucky, Indiana, and even Missouri, to illegally 
obtain a prescription, I think that's basically what we are 
here to discuss and debate, and to try to recognize.
    I also see Senator Hutchinson in the crowd, and I 
appreciate his helping educate me on this issue.
    And, with that, I'll yield back my time.
    Mr. Norwood. Mr. Stupak, you are recognized for 5 minutes.
    Mr. Stupak. Mr. Chairman, I have a wonderful opening 
statement, but with all due respect to our witnesses I'm going 
to waive it.
    It's good to see our colleague, Mr. Rogers, here. I know 
he's worked on this issue, and, Doctor Manchikanti, I look 
forward to continuing to work with you.
    I waive it, Mr. Chairman.
    Mr. Norwood. Thank you very much.
    I remind all of you, you can waive and pick up extra time 
in your questioning, so we can get to the panel.
    Mr. Buyer, you are recognized for 5 minutes.
    Mr. Buyer. Thank you.
    Mr. Chairman, I want to thank you, Mr. Bilirakis, for 
holding this hearing, and, Hal, for you to be here. We are 
anxious to receive your testimony. I also recognize a former 
colleague of ours who is sitting out here in the audience, Tim 
Hutchinson, former U.S. Senator, thanks for being here.
    I'm pleased that we are going to address this issue, and I 
welcome your testimony. Two points I would like to address and, 
hopefully, you can touch on it in your testimony. One is, we 
can talk about abuse and illegal use, how serious that is, but 
there are also issues about over medication. A lot of these 
people, we have patients who are over prescribed, and we also 
have patients who are very demanding upon their doctors for 
immediate relief. And, sometimes we are a little too eager to 
write scrips, I think. Second is, there's a dark side of the 
medical practice that nobody likes to talk about. We can put 
these monitoring programs in place, but we don't like to talk 
about the dark side, and that's the illegal use and abuse by 
doctors themselves, by pharmacists themselves, by dentists 
themselves, the dark side of medical practice. And so, I 
welcome your testimony to discuss that today.
    We can't just talk about monitoring programs as though the 
medical profession, yes, they are going to police this system, 
yet who is policing themselves.
    Thank you, I yield back.
    Mr. Norwood. Thank you very much, Mr. Buyer.
    Mr. Strickland, you are now recognized for 5 minutes.
    Mr. Strickland. Thank you, Mr. Chairman, and I want to 
thank you for organizing this hearing today.
    I am interested in deterring the prescription drug 
diversion because of the immense problem of OxyContin abuse in 
many rural areas.
    I note my colleague from Kentucky, who has a district much 
like mine, and I have witnessed, personally witnessed, doctors 
coming into my little hometown of Lucasville, Ohio, setting up 
shop for 2 or 3 weeks, putting a handwritten sign on their door 
saying, ``All doctor's visits $250 cash,'' not accepting any 
credit cards, not accepting any checks. They left Lucasville, 
went to Chilliconte, Ohio, were there for 3 or 4 weeks, then 
they went to Hanging Rock, Ohio, occupied a place that was a 
former bar, were there for a few weeks until they were burned 
out. I don't know if it was an accident or not. The local 
sheriff told me they were going to be taken care of. Then they 
went to Jackson, Ohio. They were there for several weeks. I 
called the FBI. I talked to the county prosecutors. I talked to 
multiple county sheriffs. I called the Ohio Medical 
Association. I called the Ohio Licensing Board, to talk about 
these guys.
    And so, this is a real problem that I have personally 
observed. I receive letters from constituents, whose sons and 
daughters have died as a result of the overdose of use of 
OxyContin. These tragedies cannot go unchecked.
    I'm sure that OxyContin is not the only prescription drug 
abused in Appalachia, but it is certainly an example of one of 
the most tragic abuse situations.
    This week, my good colleague, the good Doctor Norwood and 
I, have introduced H.R. 3870, titled, ``The Prescription Drug 
Abuse Elimination Act.'' The bill is a comprehensive effort to 
close loopholes in current law that lead to prescription drug 
abuse. In addition to creating a prescription drug monitoring 
program like those we will learn about at this meeting, the 
bill also seeks to regulate Internet pharmacies, the drug 
distribution process, and the personal importation of 
controlled substances.
    The bill won't stop all prescription drug abuse, but its 
passage will be a big step in the right direction. The bill 
Doctor Norwood and I have introduced will build on existing 
State prescription monitoring programs, by providing grants 
through the Department of Health and Human Services for States 
to establish, operate and update prescription monitoring 
programs. In addition to meeting some basic requirements, 
States accepting these grants will be required to ensure that 
their monitoring systems can share information with other 
States. That's especially important in a region like mine. My 
district borders Pennsylvania, West Virginia and Kentucky.
    Aside from these mandates, the States would have the 
responsibility of determining whether the data base can be 
queried, and who was allowed to query it. Our intention is to 
expand and improve current system State monitoring programs 
without eliminating the work, for example, that Kentucky and 
Nevada has already done.
    I know that one argument against prescription monitoring 
programs is that they will have a chilling effect on doctors' 
willingness to prescribe pain medications to patients.
    I hope to learn from the witnesses who testify today that 
this has not been the case in the States that have already 
established monitoring programs. I believe that drugs like 
OxyContin are important advances in the treatment of pain and 
pain management, and we must do everything possible to educate 
doctors and other health providers in their proper use.
    One of the problems that we have in this country is the 
under-utilization of such wonderful drugs in order to control 
pain. But, prescription monitoring, regulation of Internet 
pharmacies, the regulation of the drug distribution system, are 
tools that should, and can be, used to ensure that important 
drugs like OxyContin are properly prescribed and not diverted 
or abused.
    So, thank you, Mr. Chairman, for this hearing, and I look 
forward to hearing from our witnesses.
    Mr. Norwood. Thank you, Mr. Strickland.
    Mr. Ferguson, you are recognized now for 5 minutes.
    Mr. Ferguson. Thank you, Mr. Chairman.
    I thank you for holding this hearing and, obviously, I'm 
very, very interested in this issue and will continue to be 
active in that.
    In deference to Chairman Rogers and the rest of our panel, 
I will waive my opening statement.
    Mr. Norwood. Thank you very much.
    Has everybody made an opening statement that wishes to?
    [Additional statement submitted for the record follows:]

 Prepared Statement of Hon. Joe Barton, Chairman, Committee on Energy 
                              and Commerce

    Thank you, Mr. Chairman, for holding this hearing today. One of the 
top priorities of my Chairmanship will be oversight of the Federal 
agencies under this Committee's jurisdiction. On Monday the President 
announced his National Drug Control Strategy to examine prescription 
drug abuse and new federal programs to address the problem. With 
several key agencies at HHS working on this project, it is imperative 
that we move forward swiftly to review existing programs and 
rationalize how to invest resources so that the new projects may be 
successfully implemented. One of the new projects outlined in the 
President's plan is the expansion of prescription drug monitoring 
programs.
    When we talk about drug abuse in America, many people automatically 
assume that the most pervasive problem is contraband drugs. According 
to the National Survey of Drug Use and Health, following marijuana, the 
misuse of certain prescription drugs like pain relievers, 
tranquilizers, stimulants and sedatives is the second most common form 
of illicit drug use. In some communities, the non-medical use of 
prescription drugs presents a bigger problem than even cocaine and 
heroin. The University of Michigan's Monitoring the Future survey for 
2003 reports that high school seniors abuse of the prescription drug 
Vicodin is more than double the abuse of cocaine, Ecstasy, or 
methamphetamines. This is a serious problem that demands real 
solutions.
    Prescription drug monitoring programs are one way that states have 
chosen to empower physicians and law enforcement officials alike to 
deter prescription drug abuse. These programs help physicians better 
serve their patients because they can review the patient's prescription 
drug history. Drug interactions can often lead to adverse events for 
patients, so these monitoring programs serve as an additional safety 
check.
    Unfortunately, less than half of the states have established 
prescription drug monitoring programs. This matters because several 
reports indicate that when a state establishes a prescription drug 
monitoring program, illicit drug use shifts to contiguous states 
without monitoring programs. Herein lies an appropriate Federal role: 
strengthening prescription drug monitoring programs so that information 
is readily available across state lines.
    I look forward to the witness testimony and working with Members of 
this Committee who have expressed an interest in moving legislation to 
address this issue.

    Mr. Norwood. Here's how we are going to run this thing. 
Congressman Rogers is going to testify first. Following his 
testimony, members are going to have an opportunity to ask 
Chairman Rogers questions for 3 minutes each. Once the question 
and answer period has expired on the chairman, we will excuse 
Mr. Rogers so he can go to his homeland security meeting.
    From that point on, then we'll go back to regular order. We 
will hear, at that point, from all the witnesses and go into 
our regular questions and answer period.
    Mr. Chairman, I, again, want to say before you start how 
much I appreciate the work, the good work that you've done in 
this for your district, for your state, and now we need to get 
this done for the rest of the country.
    So, with that, we ask you to give us your testimony.

 STATEMENT OF HON. HAROLD ROGERS, A REPRESENTATIVE IN CONGRESS 
                   FROM THE STATE OF KENTUCKY

    Mr. Rogers. Well, thank you, Mr. Chairman, and thank you 
for holding this hearing. It's all important, and you are to be 
commended for it, that especially, and all of the members of 
the subcommittee who are here and taking a deep interest. It is 
well overdue.
    Mr. Chairman, I have a written statement that I will submit 
for the record, and I will attempt to summarize it, if that 
would please you.
    Mr. Norwood. Yes, sir.
    Mr. Rogers. Mr. Chairman, the scourge of prescription drug 
abuse is the most devastating thing that I've ever seen in my 
more than 30 years of public service. Drugs are tearing 
families apart, stretching the resources of law enforcement, 
threatening the takeover of local governments, stretching 
Social Service agencies to the absolute limit, and killing 
people, especially young people.
    My district in Southern and Eastern Kentucky has become the 
prescription painkiller capital of America. On a per capita 
basis, our drugstores, hospitals, and other legal outlets 
receive more prescription painkillers than anywhere else in the 
Nation.
    From 1998 to 2001, nearly a half a ton of narcotics reached 
just seven small mountain counties, the equivalent of more than 
3,000 milligrams per adult who lives there.
    While some of this medication is for legal purposes, too 
much of it is not. A public defender in Perry County, a small 
mountain area in my Congressional District, estimated that 95 
percent of his clients either sell or abuse prescription drugs. 
Because of the drug epidemic, our courts are unable to keep up 
with the overwhelming pace of new crimes. Eastern Kentucky 
court dockets are jammed with drug cases--in recent years 
charges for controlled substances have jumped 348 percent. Our 
residential drug treatment centers are overwhelmed, admissions 
tripling in the last 5 years. People are dying.
    Nationwide, OxyContin played a major role in 464 overdose 
deaths throughout the Nation between May of 2000 and February 
2002. About a quarter of those occurred in Kentucky and 
Virginia alone. These deaths are not just statistics, Mr. 
Chairman, they represent real people.
    I'm drawn now to a personal friend, my Sheriff of my 
County, a long-time personal friend, 15 years Sheriff, won 
national awards, the Sheriff of the Year in Kentucky, just a 
model of law enforcement. Some 2 years ago, went to a political 
picnic out in the county at a volunteer fire department, the 
bake sale, went to his car to leave and was assassinated by a 
sniper hiding in the woods a few yards away, an OxyContin 
addict who was doing the bidding of a competitor candidates for 
Sheriff, who wanted to take over the Sheriff's office to run 
the drug business in the county.
    I had the obligation to deliver Sam Catron's eulogy to a 
crowd of 5,000 people, and, Mr. Chairman, I don't want to do 
that again.
    That's how insidious this problem is. Why is it a big 
problem, it's such a problem in my region, I can't explain that 
to you, except to say that I believe too much of the product is 
on the market, both legal and illegal, and finding its way into 
the hands of the wrong people, unfortunately, so many young 
people. OxyContin has been over-aggressively marketed to rural 
physicians as a ``safe'' alternative for long-lasting pain 
relief. Most often, these doctors don't specialize or have any 
expertise in pain management.
    Now, I want to say, OxyContin is a miracle drug. It's a 
wonderful thing, for the right patients, at the right times. I 
know from personal experience how needed it is in terminally 
ill cancer patients, for example.
    But, it's been defined, and the FDA has ruled, that it can 
be used for moderate to severe pain. And, consequently, doctors 
are prescribing it for toothaches, and for broken fingers, and 
that type of thing, and it really eases the pain, but it's such 
a dangerous drug, Mr. Chairman, so addictive, and so easily 
abused, that I wish the FDA, and I've testified before them to 
request, that they change the ruling so that it can only be 
used for severe pain, not moderate pain.
    Let me give you a couple of examples of what some corrupt 
doctors are doing in Kentucky. One doctor prescribed more than 
2.3 million pills, to more than 4,000 patients, during a span 
of 101 days. Officials likened his operation to a drive-through 
prescription service.
    Another doctor in Harlan County, who is now serving 20 
years on a Federal drug conviction, saw 133 patients a day, 
even this office had no electricity. Similar, Mr. Strickland.
    It's a problem that I've not seen the likes of in my 
experience, such that we started--I felt compelled in my 
district, 29 counties, Eastern Kentucky, to start an 
organization that we are now cranking up called UNITE, Unlawful 
Narcotics Investigations, Treatment and Education, three prongs 
to the attack, [1] law enforcement; [2] treatment; [3] 
education. We divided the region into three pieces. We've 
secured the appropriations. We are now in the process of 
setting up law enforcement activities to assist the locals. 
We'll hire 33 undercover agents, even though the State only has 
16 for the whole State. These are pros, they will work for the 
State.
    We are starting--we'll have six new special prosecutors to 
travel throughout the region, helping prosecutors prosecute. 
The State Supreme Court Chief Justice is a part of our 
organization, he has now begun to set up drug courts in every 
county, every district, which will be an enormous help to us. 
We will lead the Nation in per capital drug courts when it's 
concluded.
    Our treatment centers are absolutely overwhelmed. You could 
spend the rest of the dollars you have in America and not have 
enough treatment capability. So, we are trying to figure ways 
to better utilize the treatment institutions we have, to engage 
the faith-based community especially in helping Big Brother and 
Big Sister people, and we're pushing for a Federal voucher 
program to allow people who would qualify to use vouchers 
anywhere, out of state, in state, public, private institutions 
or the like, to secure treatment.
    And, we're going to every school and establishing UNITE 
clubs, to help young people stay away from the problem. UNITE 
has a three message approach. To young people we say, get 
smart, stay away from this stuff. To the user, the addict, the 
non-criminal addict, we are saying, get help, we'll help you. 
And, to the pusher, whether it be a doctor or otherwise, we are 
saying, get out. And, that program now is drawing 200-300 
people a county, as we come to those coalition building 
meetings, a most incredible outpouring of support and fear that 
I've seen.
    Now, UNITE is a new program, but we've, as you say, been 
working with many of you on this committee on this problem for 
some time. In 2001, we were able to include in the Federal 
Appropriations Bill a sum of money to create the State 
Prescription Drug Monitoring Grant Program. Mr. Chairman, Frank 
Wolfe graciously provided the money for it. It's administered 
by the Bureau of Justice Administration in cooperation with 
DEA, that awards grants to States looking to start a 
prescription drug monitoring program, or to enhance an existing 
one. This State-by-State approach is supported by DEA, the 
National Alliance for Model State Drug Laws, the President and 
the National Office.
    Just this Monday, ONDCP Director Walters announced that 
this drug monitoring program is one of the cornerstones of the 
President's new National Drug Control Strategy. To date, we've 
appropriate $16.5 million for this program, 18 States currently 
have monitoring programs in place. We expect 22 States to have 
theirs up and running by the end of the year. $6.5 million has 
been awarded, nine established grants and seven enhancements.
    These State prescription monitoring systems, Mr. Chairman, 
are having a very positive effect, in curbing the abuse of 
controlled drugs by clamping down on doctor shopping. A couple 
of examples. Prior to the implementation of the Kentucky 
program, State drug control authorities took an average of 101 
days to complete their diversion investigations. That average 
time now has dropped to 19 days. I want to see it real time 
eventually.
    Nevada reduced their investigation time from 120 to 20 
days. Utah, an 80 percent reduction in that time. State systems 
clearly work as a deterrent to would-be criminals, and help 
reduce the availability of abuse substances.
    GAO, our internal investigative arm, concluded the very 
same thing in a May, 2002 report. In the States that currently 
have monitoring systems, investigation times and productivity 
have dramatically improved, and illegal diversion is down.
    One of the hallmarks of this program is the flexibility it 
provides States in setting up their own prescription drug 
monitoring program. There is no correct, one-size-fits-all 
approach in my judgment. Each State sets up the program 
according to their own unique needs. Kentucky houses its 
program in the Department of Health. Texas, the Law Enforcement 
Agency. Both programs are highly successfully.
    The ultimate goal is to see that all 50 States have some 
form of monitoring programs, and that those systems communicate 
regionally.
    So, Mr. Chairman, the decisions you make here in Washington 
will have tremendous impact on the lives of people, I hope 
saving many lives. This is a life and death matter, and I 
salute you and your committee for bringing this matter before 
us.
    [The prepared statement of Hon. Harold Rogers follows:]

  Prepared Statement of Hon. Hal Rogers, a Representative in Congress 
                       from the State of Kentucky

    Thank you for allowing me to testify before you today regarding 
prescription drug abuse and prescription drug monitoring programs. This 
subject is of critical importance to me, the people in my district, and 
the nation as a whole.
    The hills and valleys of Southern and Eastern Kentucky are home to 
some of the most beautiful scenic wonders in the country. Although we 
have been historically isolated from the rest of the country by the 
Appalachian Mountains, Eastern Kentuckians are proud of our rich 
heritage. The area is the birthplace of bluegrass music and is the 
location of the Cumberland Gap which allowed Daniel Boone and other 
pioneers to carve their way out west.
    Unfortunately, these same remote hills and valleys have not been 
isolated from the scourge of prescription drug abuse. This is the most 
devastating thing I've ever seen in my more than twenty years of public 
service. Drugs are tearing families apart, ruining lives, and 
stretching the resources of law enforcement and social service agencies 
to the absolute limit.
    The problem has literally reached epidemic proportions in my 
District. In fact, Southern and Eastern Kentucky has become the 
prescription pain-killer capital of the United States. An analysis of 
federal drug data found that, on a per capita basis, our drugstores, 
hospitals, and other legal outlets received more prescription pain-
killers than anywhere else in the nation.
    From 1998 to 2001, nearly half a ton of narcotics reached seven 
small mountain counties--the equivalent of more than 3,000 milligrams 
for every adult who lives there. For reference, a typical pill might 
contain 10 to 20 milligrams. While some of this medication is for legal 
purposes--too much of it is not. These drugs are hitting the streets 
resulting in addiction, crime, and death.
    Our courts are unable to keep up with the overwhelming pace of new 
crimes. A public defender in Perry County, a small mountain area in my 
Congressional District, estimated that 95% of his clients either sell 
or abuse prescription drugs. Eastern Kentucky court dockets are jammed 
with drug cases--in recent years charges for controlled substances 
jumped 348%. Subsequently cases are delayed for months, if not over a 
year, before they are brought to trial. These delays can lead to 
unreasonable plea bargains or dismissal altogether. In either case, 
justice is not truly served and pill pushers go back to plying their 
trade.
    Additionally, Kentucky's residential drug treatment centers are 
overwhelmed, with admissions tripling since 1998. A Prestonsburg, KY 
drug treatment program director reports that the new patients, most 
hooked on OxyContin, are younger and sicker than clients in previous 
years. Over half of newly admitted patients to drug treatment centers 
in Kentucky have identified OxyContin as their drug of choice.
    Most tragic of all, our people are dying. Nationwide, OxyContin 
played a major role in 464 overdose deaths throughout the nation 
between May of 2000 and February of 2002--about a quarter of these 
deaths occurred in Kentucky and Virginia alone. These deaths are more 
than just statistics--these numbers represent real people that have 
been taken away forever.
    For me, two of these deaths made an indelible impression, putting a 
face on the tragic consequences stemming from Oxycontin abuse. In 2001, 
I invited Pastor Ron Coots to testify before the Commerce, Justice, 
State Appropriations Subcommittee for a hearing we held on Oxycontin 
abuse. His son Joshua--a bright young man from a good home with a 
promising future--had been hooked on OxyContin and sat by his side 
during the hearing. Joshua had gone to rehab and was clean of OxyContin 
when he came before our Subcommittee. I'll never forget Pastor Coots 
telling me about the pain that Joshua's drug problem caused his family 
but how proud he was that Joshua had confronted his problem and beaten 
it. Less than a year after that hearing, Joshua got hooked on OxyContin 
again and died of an overdose.
    Another tragic story I want you to share with you is that of 
Sheriff Sam Catron. Sam was a friend of mine and one of the finest law 
enforcement officials Kentucky has ever seen. On Saturday, April 13, 
2002, Sheriff Catron began the day like any other day putting on the 
brown and yellow uniform of his proud department. That Saturday 
happened to be an important day for him as well. He was set to appear 
on television's America's Most Wanted to help in the search for a 
fugitive from justice. Up for re-election, Sam also had a candidate's 
night in Shopville, KY. After meeting with local citizens, he headed to 
his car in order to travel home - to see himself on TV no doubt. But 
from the shadows came the shot from a snipers rifle; in an instant, Sam 
lay dead on the ground. I gave his eulogy later that week.
    It turns out that the man who pulled the trigger was an OxyContin 
addict. He was hired to assassinate Sheriff Catron by Sam's political 
rival and in his need to buy more OxyContin, he did perform the job. In 
this case, OxyContin addiction took one life and completely ruined 
another as the killer will spend the rest of his life behind bars.
    Why do we have such a terrible problem with OxyContin abuse in my 
district? Simply put, too much of this product is on the market and is 
finding its way into the hands of the wrong people. There is a 
veritable glut of OxyContin making its way onto our streets.
    Purdue Pharma has improperly marketed OxyContin as a ``safe'' 
alternative for long lasting pain relief. The truth is there is no hard 
epidemiological data to support that claim. The New York Times reported 
that Judge Sidney H. Stein of the Federal District Court in Manhattan 
ruled that Purdue Pharma's patents for OxyContin were invalid because 
of misrepresentation. To win its patents, Purdue Pharma claimed that 
OxyContin was unique because 90 percent of patients got pain relief by 
taking very little medicine. In reality, OxyContin's inventor had done 
no clinical studies and had no evidence to validate this claim. Despite 
acknowledging that this figure was manufactured in the mind of its 
inventor, Purdue Pharma executives continued to assert the validity of 
this claim even though they knew there was no evidence to back it up!
    General practitioners in rural areas became an easy target for 
Purdue Pharma and its sales force. Family doctors rarely have much 
formal training in pain management and can be wary of prescribing 
morphine because of its track record of addiction and abuse. The 
company invested $500 million into a marketing campaign and its sales 
representatives enticed doctors with claims that OxyContin was the 
``safe'' alternative to morphine. In reality, a 1999 Purdue-sponsored 
study concluded that Oxycontin is nearly twice as potent as an equal 
amount of morphine.
    Further compounding the problem is the fact that the Food and Drug 
Administration has approved OxyContin for ``moderate-to-severe'' pain. 
Due to the subjective nature of ``moderate'' pain, OxyContin is far too 
easy to prescribe and obtain. Many doctors are issuing this powerful 
medication for everything from a backache to a sore toe. While it is a 
wonderful drug for terminally ill cancer patients or others suffering 
from severe chronic pain, the FDA dropped the ball in their initial 
review of OxyContin by failing to recognize the drugs'' potential for 
widespread abuse. It is clear to me that the FDA should limit the 
prescribing of this drug to severe pain only.
    The moderate indication also makes it much easier for patients to 
``doctor-shop'' and trick unsuspecting practitioners. Moving from 
doctor to doctor with feigned injuries, scores of patients are putting 
their hands on these powerful narcotics and either getting high 
themselves or selling the drugs for a tidy profit. A $6 pill of 
Oxycontin can sell for $80 while a bottle of 40 milligram pills can 
fetch $2,000 on the street.
    Unfortunately some of the very people sworn to protect life are 
actually peddling these drugs for their own personal gain. For 
instance, a doctor practicing in the northern Kentucky region was 
arrested by federal authorities last September for prescribing drugs 
without a lawful purpose. On average this doctor was handing out 800 
prescriptions a month, which balances out to almost 40 prescriptions 
each working day.
    What is most appalling in this case is that this doctor actually 
expressed concern after his colleagues gave him grief about the amount 
of OxyContin he was prescribing. He expressed this concern to his 
Purdue Pharma sales representative. How did his Purdue Pharma 
representative respond to one of his top purchasers? The sales 
representative reassured the doctor by telling him that he was ``doing 
the right thing.''
    Another doctor in Kentucky prescribed more than 2.3 million pain 
pills of different varieties to more than 4,000 patients during a span 
of 101 workdays. Officials likened his operation to a drive-thru 
prescription service.
    Still another doctor in Harlan County, who is currently serving 20 
years on a federal drug conviction, saw 133 patients in one day, even 
though his office had no electricity. It was reported that he had been 
prescribing OxyContin and Viagra to teenage boys. This is just a 
sampling of the problem from Kentucky; similar stories can be repeated 
across the nation.
    In order to combat the epidemic of drug abuse in my Congressional 
District, I have initiated a program called Operation UNITE (Unlawful 
Narcotic Interdiction Treatment and Education) with $16 million in 
appropriations over the last two fiscal years. There are three main 
components to the program: Law Enforcement, Treatment, and Community 
Involvement. The success of this program lies in its ability to bring 
people together for the greater good. Federal, state, and local 
officials work alongside members of the community to eradicate the 
scourge of drug abuse from the region.
    Drug abuse has stretched the resources of law enforcement to the 
breaking point in my area. Operation UNITE addresses this problem by 
creating 3 regional task forces and hiring 32 law enforcement officers 
to perform undercover operations, which is twice the number of 
undercover narcotics street agents currently employed by the entire 
Kentucky State Police. We are also working to create greater 
coordination among local, state, and federal law enforcement agencies. 
As a result of these combined efforts, we expect the number of arrests 
and prosecutions for street-level trafficking to increase dramatically. 
Resources will also be provided to overburdened prosecutors so they can 
effectively convict dealers and keep them off of our streets. The 
creation of a new forensic drug lab will dramatically decrease the wait 
for narcotics analyses thereby decreasing the time it takes to bring 
cases to trial.
    Getting dealers and corrupt doctors off the street is one thing--
real success lies in getting those hooked on drugs back on track. As I 
mentioned earlier, our treatment centers are overwhelmed. Operation 
UNITE will address the issue in three stages. In the short term, 
treatment resources will be coordinated to maximize their potential, 
making the most of what we already have today. In the intermediate 
term, drug courts will be created in all 29 UNITE counties. This two-
pronged approach will allow our criminal courts to focus on convicting 
dealers and the drug courts to sentence those of lesser crimes to the 
treatment they sorely need. Finally, our long term goal is to create 
new residential treatment centers and after-care programs in order to 
reduce the waiting period for those who want help kicking the drug 
habit.
    In the past, a lack of coordination between organizations providing 
drug treatment services existed so that one hand did not always know 
what the other was doing. Some areas or segments of the population were 
over-served while others were completely neglected. The important 
messages being sent out could become muddled or, worse yet, 
conflicting. Operation UNITE will coordinate these efforts and everyone 
will be encouraged to become part of the solution. Local citizens will 
be empowered to join together. The significant resources and abilities 
of faith based groups and civic organizations will be tapped. Schools 
will be a focal point so that students can help fight the problem 
instead of becoming a part of it.
    While Operation UNITE is the latest step in the effort to fight 
drug abuse in Eastern Kentucky, I have been working to address this 
problem on a national level for many years. Recognizing that Kentucky's 
problems with drug diversion do not simply exist within its geographic 
borders, I started the national ``Hal Rogers Prescription Drug 
Monitoring Program'' in 2001.
    This program is managed by the Bureau of Justice Administration in 
cooperation with the Drug Enforcement Administration and awards grants 
to states either looking to either start a Prescription Drug Monitoring 
Program (PDMP) or enhance an existing program. The National Alliance of 
Model State Drug Laws provides technical assistance for states who seek 
it. The Alliance also facilitates communication between states that are 
considering PDMPs and states that already have a program in place to 
encourage compatibility. The Alliance receives $1 million annually from 
the Department of Justice through the ONDCP to assist them in their 
work.
    DEA also offers tremendous help to states building PDMP's or those 
that are working to improve their existing program. The Controlled 
Substances Act of 1970 gave DEA oversight of doctors and pharmacies for 
the prescribing and dispensing of federally controlled substances. 
Since the 1980's the DEA has promoted state PDMP efforts to detect the 
illegal diversion of drugs. DEA has long served as an important program 
resource for states seeking assistance in developing PDMPs and provide 
valuable assistance to states that have questions about promulgating 
monitoring regulations.
    I am pleased to report to this Subcommittee that this state-by-
state approach is working. In fact, just two days ago it was announced 
that the Hal Rogers Prescription Drug Monitoring Grant program is one 
of the cornerstones of the President's new National Drug Control 
Strategy on prescription drug abuse. To date, Congress has appropriated 
$16.5 million for this program. By the end of 2004, we expect 22 states 
to have prescription drug monitoring programs in place with that number 
possibly reaching as high as 25 pending action from three different 
state legislatures.
    From the late 1930's, when the first prescription drug monitoring 
program was established in California, until 2001, 15 states had 
established prescription drug monitoring programs. While it took over 
60 years to establish those first 15 programs, 7 new programs will be 
up and running just three years after the Hal Rogers Prescription Drug 
Monitoring Program was created. That's nearly a 50% increase in a very 
short period of time.
    In a 2002 report, the GAO found that Prescription Drug Monitoring 
Programs have helped reduce the availability of abused drugs. In fact, 
it was found that the institution of a PDMP in a state typically leads 
to a decrease in diversion while neighboring states without a program 
find increased diversion. Furthermore, the GAO also found that, ``The 
ability of PDMP's to focus law enforcement and regulatory investigators 
on suspected drug diversion cases to specific physicians, pharmacies, 
and patients who may be involved in the alleged activities is crucial 
to shortened investigation time and improvements in productivity.'' In 
Kentucky, for example, drug control investigators took an average of 
101 days to complete an investigation prior to the implementation of 
the KASPER system in 1999. That average has since dropped to 19 days. 
Nevada reduced its investigation time from 120 days to 20 days. Utah 
has experienced an 80% reduction in its investigation time.
    One of the hallmarks of this program is the flexibility it provides 
states in setting up their own prescription drug monitoring program. Of 
the 18 programs currently up and running, each one is unique and set up 
according to the diversion needs of that particular state. Each state 
addresses concerns over access and privacy in a manner acceptable to 
their respective citizens. Some states, like Kentucky, house their 
program in a health services agency while others, like Texas, house it 
in a law enforcement agency. Because of this localized approach, each 
state with a PDMP finds their program to be an unqualified success.
    As legislators we all know that a program will only succeed if the 
entity running it has bought into the system. The federal government 
must allow states to begin a PDMP when they have the financial, 
technical, and administrative means necessary to put together a system 
that works and that will last for the long haul.
    While it is essential that this program work on a state-by-state 
basis, we must continue providing encouragement and assistance for new 
states to come on line and for existing states to make their programs 
interoperable with neighboring states. It is my goal to see that all 50 
states have some form of a prescription drug monitoring system and that 
those systems communicate regionally in order to prevent cross border 
doctor shopping. Although budgets, both federally and locally, are 
tight, states should also look to incorporate real-time reporting 
systems. This would enable doctors, pharmacists, and law enforcement to 
quickly recognize when drugs are falling into the wrong patients' 
hands.
    The problems associated with drug abuse are ones that we as a 
society do not take lightly. The social, moral, and economic costs are 
staggering. Families are torn apart and promising lives can be lost 
when individuals venture down the path of sustained drug abuse. For too 
long we focused our drug control strategy on illicit substances like 
marijuana and cocaine and forgot about the plague that could be hiding 
behind each of our medicine cabinets. Prescription drug monitoring 
programs serve as important law enforcement, regulatory, and doctor 
intervention tools and have proven highly effective in fighting drug 
diversion. I am gratified that our President has recognized the 
importance of fighting prescription drug abuse and am honored to be a 
part of his plan. I am also pleased with the progress Congress has made 
in helping spread monitoring programs across the country. I look 
forward to working with each of you to continue these efforts in the 
years to come.

    Mr. Norwood. Thank you very much, Mr. Chairman, and all of 
us again owe you a debt of gratitude for shouldering this 
burden, really, by yourself for a long time.
    My sense of it is the calvary is on the way. I think 
Congress is fixing to crank up on this.
    Mr. Rogers. I hear the hoof steps.
    Mr. Norwood. Anybody on our side wish to ask the chairman a 
question?
    Mr. Chairman?
    Mr. Bilirakis. Just very quickly.
    Who is at fault? Who would you say is more at fault in this 
particular problem?
    Mr. Rogers. You mean the drug abuse problem?
    Mr. Bilirakis. No, I'm talking about the particular 
problem--well, the drug abuse problem, but the particular 
problem in your area, this particular drug, the misuse of it.
    Mr. Rogers. OxyContin.
    Mr. Bilirakis. Yes.
    Mr. Rogers. It's a tough one to answer. My area has a lot 
of pain-afflicted people, older population, a lot of coal 
mining disability retirees, pensioners if you like, people who 
have need for pain medication. So, there's a sort of a--there's 
an atmosphere there, I think, particularly, with the 
susceptibility of this kind of problem.
    But then, you know, we've had a few bad-egg doctors who 
exacerbated the problem. Now, the meth labs are moving in, and 
OxyConton is sort of, not fading away, but not the predominant 
problem it was.
    But, it's a National problem. I mean, we are not unique in 
this. It may have started in Eastern Kentucky, OxyContin abuse, 
but now, of course, it' spread nationwide.
    Mr. Bilirakis. Well, we'll be hearing from the other 
witnesses, too, but I just--you know, we can do so many of 
these things, but sometimes we don't get right to the 
foundation of the reason for the problem.
    Based on what you've told me about a couple of doctors, I 
know we don't want to put all doctors in that same category, 
you know, in my mind I've just been wondering if they've been 
reported to the State Medical Association, are they expressing 
any concern about this?
    Mr. Rogers. Oh, sure, the State Medical Association has 
been especially aggressive. These doctors I'm telling you about 
are in the penitentiary now. The U.S. Attorney has been very 
aggressive. He's a part of our UNITE campaign, by the way, the 
U.S. Attorney for the Eastern District, and he's a very 
aggressive prosecutor of these types of cases.
    But, I emphasize again, these are just a few bad-egg 
doctors that, primarily, are not local people. They came in 
there, much the same as Mr. Strickland mentioned, to make a 
buck.
    Mr. Bilirakis. Not members of the Medical Association of 
the county, of the state.
    Mr. Rogers. Well, they are, they have to be, but they are 
not regular people.
    Mr. Bilirakis. Thank you.
    Mr. Norwood. And, do we have a jail for them at some point?
    Mr. Rogers. Pardon me?
    Mr. Norwood. Do we have a jail for them at some point?
    Mr. Rogers. For who?
    Mr. Norwood. These bad doctors that are over-prescribing 
and coming through?
    Mr. Rogers. Yes.
    Mr. Norwood. I mean, that's the worst possible thing I 
believe that a physician can do, and it blackens the eye of 
every good doctor in America.
    Mr. Rogers. I could tell you many more instances that would 
raise the hair on your head. They are in the penitentiary now, 
we got them.
    Mr. Norwood. Mr. Brown, do you care to ask a question?
    Mr. Brown. Only, not really a question, but I just wanted 
to thank Mr. Rogers for portraying this problem so dramatically 
to us and so effectively. Thank you.
    I also, Mr. Chairman, ask unanimous consent, Mr. Towns 
asked me to submit a statement from the Coalition to Assist 
Victims of OxyContin.
    Mr. Norwood. So ordered.
    [The statement follows:]
   Prepared Statement of The Coalition to Assist Victims of Oxycontin
    Mr. Chairman and Members of the Committee: The Committee to Assist 
Victims of Oxycontin offers testimony today to assert that the 
prescription drug problem in America is much deeper than it appears at 
first glance. While it is clearly very important that Congress 
concentrates on the serious problem of prescription drug abuse--and we 
applaud this committee for its role in that work--we believe there is 
an aspect of this issue that has not received the attention it 
deserves.
    The part of this story that hasn't been told is the disturbing 
number of people who took prescription drugs--really, took medicine--
exactly as prescribed by their physician and have become addicted, or 
even who have become abusers themselves, because neither they nor their 
doctors knew of the addictive potential of certain prescription drugs. 
In short, any real effort to address the abuse of prescription drugs 
must address the problem of addiction first.
    We are primarily concerned with, for example, the painkiller 
OxyContin. The American public has been routinely bombarded by 
headlines and evening news stories about the havoc this drug has has 
wreaked on our citizens. At this point, we barely raise an eyebrow when 
we read that another person overdosed, that someone robbed a pharmacy, 
or that a doctor is being investigated for running a so-called ``pill 
mill.'' But we rarely, if ever, read a story about someone whose life 
has fallen apart because of a drug addiction that snuck up on them 
wihout warning. It is a quiet epidemic, but it is assuredly happening 
all over America.
    Now, Purdue Pharma and its agents and defenders of OxyContin might 
claim every single incident of addiction is the result of drug abuse. 
And they have said all the right things about drug abuse and have even 
provided funding for anti drug abuse efforts across the country. But, 
with all due respect, American history is rife with tales of large 
corporations and their ``voluntary efforts'' to protect the health 
interests of their customers. We would respectfully assert that such 
efforts have not been universally sincere or successful. The case of 
the tobacco companies is the most infamous, but we believe it is safe 
to assume that Congress should regard assertions by corporate agents 
with a degree of skepticism. We do not believe today that everyone who 
becomes addicted to OxyContin is abusing the drug. We do not believe 
that every OxyContin addict became addicted by crushing the pills or 
any of the other activities associated with recreational drug use. We 
believe that many--too many--are becoming addicted, and may be 
advancing to abusive behavior because of their addiction. This drug is 
much more dangerous and addictive than is being disclosed.
    But still, we will need objectivity. Many people rely on these 
medicines, including OxyContin. By all accounts OxyContin is a vital 
tool in managing certain types of severe pain like that faced by cancer 
victims and others. Let us be clear that nobody, not even the most 
vocal critics of OxyContin, assert that the drug should be banned--
although they do suggest that perhaps additional precautions should be 
taken when prescribing it and perhaps doctors have been misinformed 
about the potential for addiction and eventual abuse.
    It is our belief that the OxyContin crisis--and make no mistake--it 
is a crisis in the towns and cities and counties across the nation. It 
is both a health care crisis and a public safety crisis and it boils 
down to some very simple issues. First, makers of the drug contended 
that its time release features would provide pain relief for twelve 
hours, and this turned out not to be the case 100 percent of the time. 
OxyContin's time release feature was a critical component of the drug 
and was one of its rationales for being granted a patent. This raises 
the question of lying to the federal Patent and Trade office and we 
understand that at least one federal judge has found, after formal 
court hearings, that Purdue indeed lied about its drug.
    It is also our understanding that the company may have mislead 
regulators by asserting that fewer than one percent of people using 
OxyContin get addicted, but indeed had not conducted appropriate 
clinical trials, or really any studies to back up this assertion. The 
result of all this is that everyday law-abiding people became addicted 
because their physicians were misled by a drug company. In turn these 
people's lives were destroyed.
    The allegation of misleading federal regulators becomes even more 
troubling when we are told that one of the people in the Food and Drug 
Administration who participated in the approval process for OxyContin 
went to work for the drug maker very soon after leaving the public 
payroll.
    So, with all these allegations and concerns in mind, we urge this 
Committee, both today and in its work in the future, to take a hard 
look at the addiction aspects of our prescription drug abuse problem. 
Clearly, the addiction of our citizens--an accidental addiction on 
their part--although perhaps not on the part of the drug manufacturer, 
cannot be tolerated.
    And frankly, we are tired of lumping hard-working, law-abiding 
citizens who followed the advice of their doctors into the same 
category with irresponsible recreational drug users, even if that 
practice is beneficial to the financial interests of those why may very 
well be responsible for their addiction.
    There is a whole population of victims whose suffering has not been 
the focus of prior efforts by Congress. To date, the focus of 
Congressional inquiries and the voluntary efforts of Purdue in response 
to those inquiries has been the issue of OxyContin diversion and abuse 
by illegal users, resulting in crimes of violence, drug overdoses and 
deaths, the maintenance of ``pill mills'' run by unscrupulous doctors 
and the proliferation of street drug dealing in this medication.
    None of these efforts, however, have focused upon the serious 
public health crisis among persons lawfully prescribed the medication 
by doctors who have unwittingly taken on faith Purdue's aggressive, 
medically unsound, and patently false representations about the 
purported non-addictive properties of this drug.
    Members of the Coalition are representative of thousands of 
Americans who became ``hooked'' on OxyContin after being prescribed and 
taken the drug as directed, sometimes for problems as minor as a broken 
bone, dental surgery pain and chronic lower back pain. Many of these 
individuals have suffered not only the physical and psychological 
ravages of addiction, but as a consequence have lost their spouses, 
children, homes, jobs and dignity. For most of these addicted victims 
there are no affordable therapies: Medicaid and Medicare do not cover 
detoxification programs, nor do private insurers.
    We urge this committee to focus on the addiction problem presented 
by OxyContin.

    Mr. Norwood. Mr. Whitfield, any questions?
    Mr. Whitfield. Thanks, Mr. Chairman, and, Mr. Rogers, we 
appreciate very much your testifying today.
    Since you are really, you are sort of recognized as one of 
the leaders in this area, because as I said in my opening 
statement, the Kentucky program is recognized as being one of 
the most effective in the country.
    And, I know that we've already had a little bit of a 
discussion about different approaches to this problem, and all 
of us are committed to trying to solve it.
    One question I'd like to ask you, I mean, I think you and I 
have had enough discussions that you are committed to the State 
approach, and, of course, the first State program started in 
1940 in California, in my understanding, and we've had like $16 
million appropriated, and the startup costs in Utah, I've been 
told, is $50,000. And yet, we only have like 16, or 17, or 18 
States with programs.
    My question would be, do you feel like that we, at a 
minimum, should mandate that States take action in this area?
    Mr. Rogers. You know, I haven't studied Chairman Norwood's 
bill, and I heard it described here, but I've not had a chance 
to examine it carefully.
    But, it sounds intriguing to me that any Federal 
legislation would not supplant the State-by-State monitoring 
programs, but would, perhaps, give them some standards by which 
they operate. That intrigues me. I want to study that very 
carefully.
    But, I think the State-by-State approach is the best way to 
go, as does the DEA, and the President, and the ONDCP, and many 
others, the uniform State laws people and the like.
    Does it have its shortcomings? Of course, it does, and the 
lack of uniformity, perhaps, is one of those. But, by the same 
token, giving each State the capability to design, test and 
make a system for their special needs I think overrides the 
detriments that might be involved with it.
    I think it's very important that these State systems, and, 
perhaps, this is where Chairman Norwood's bill would be most 
important, those State systems need to be shared across the 
border. That's terribly important to all of us, especially in 
my region. We border on Tennessee, West Virginia and Virginia. 
Until recently, none of them had a system, and we would see 
people living near the State line, cross the border, and escape 
monitoring. That needs to be part of what they do.
    Whether we mandate that, I'm not sure of that yet. I want 
to study his bill to see just how that works.
    It took us 60 years to establish these first 15 monitoring 
programs, but seven new programs will be up and running just 3 
years after the monies we set aside was created. That's nearly 
a 50 percent increase in a very short period of time. So, I 
think we are making good progress.
    We've got a ways to go, but I'm really nervous about 
Federal takeover of the program.
    Mr. Norwood. Mr. Stupak, do you have a question of the 
chairman?
    Mr. Stupak. Yes. This committee spent, especially oversight 
investigations, numerous hearings on OxyContin coming in this 
country, especially through the mail, of tens of thousands of 
receptacles go through our mail every year. Are you finding 
that being part of the problem down in Kentucky?
    Mr. Rogers. Well, yes, the Internet purchase of OxyContin 
is widespread. So, yes, it is a problem, big problem.
    Mr. Stupak. Has you, or anyone from the Kentucky, worked 
with the FDA to try to crack down on this mail order, Internet 
sales?
    Mr. Rogers. I'm going to let Doctor Holsinger address that, 
perhaps, in a few minutes. He would know more of that than, 
perhaps, I would.
    Mr. Stupak. Okay.
    Enjoyed your testimony, it was very graphic. Thanks.
    Mr. Rogers. Thank you.
    Mr. Norwood. Mr. Chairman, thank you very much for the time 
that you've give us. All of us want the same thing, we've just 
got to work out the wrinkles.
    Mr. Rogers. Mr. Chairman, if I could just say in closing 
how much I appreciate you and your dedication to this problem, 
and Chairman Bilirakis, and Ed Whitfield, and others of you 
there, we appreciate the work that you are doing.
    And, this is a problem that is not going to go away 
voluntarily, and I so much appreciate your willingness and this 
committee to start driving a solution across the whole country.
    Mr. Norwood. Thank you, sir, and you are excused.
    Mr. Rogers. Thank you.
    Mr. Bilirakis. You would think that with all the supposed 
power of this committee that we'd be a little more comfortable 
up here trying to get up from one seat--it's terrible.
    Anyhow, Ms. Crosse, why don't you proceed, please?

  STATEMENTS OF MARCIA CROSSE, HEALTH CARE, PUBLIC HEALTH AND 
 MILITARY HEALTH CARE ISSUES, U.S. GENERAL ACCOUNTING OFFICE; 
   DANNA E. DROZ, EXECUTIVE DIRECTOR, BOARDS OF PHARMACY AND 
     NURSING HOME ADMINISTRATORS; JAMES W. HOLSINGER, JR., 
SECRETARY, KENTUCKY CABINET FOR HEALTH AND FAMILY SERVICES; AND 
 LAXIMAIAH MANCHIKANTI, AMERICAN SOCIETY OF PREVENTIONAL PAIN 
                           PHYSICIANS

    Ms. Crosse. Thank you, Mr. Chairman.
    Mr. Chairman and members of the subcommittee, I am pleased 
to have the opportunity to testify as the subcommittee 
considers drug monitoring strategies for deterring prescription 
drug abuse. I will briefly summarize my written statement.
    The increasing diversion of prescription drugs for illegal 
purposes or abuse is a disturbing trend in the Nation's battle 
against drug abuse. Diversion activities can include doctor 
shopping by individuals who visit numerous physicians to obtain 
multiple prescriptions, illegal sales of prescription drugs by 
physicians or pharmacists, prescription forgery, and purchasing 
drugs from Internet pharmacies without valid prescriptions. The 
most frequently diverted prescription drugs are controlled 
substances that are prone to abuse, addiction and dependence, 
such as drugs containing opioids, tranquilizers or stimulants.
    Some States operate prescription drug monitoring programs 
as a means to control the illegal diversion of prescription 
drugs. My remarks today will focus on how State monitoring 
programs compare in terms of their objectives and operations, 
and the overall impact of State monitoring programs on illegal 
diversion of prescription drugs. My comments are based on our 
May, 2002 report on State monitoring programs, and their 
usefulness as a tool for reducing diversion.
    In brief, we found that 15 States operated monitoring 
programs in 2002, as a means to control the illegal diversion 
of prescription drugs that are controlled substances. In 
addition, West Virginia resumed operation of a program in 2003, 
bringing the total of current State programs to 16. Other 
States have programs in development.
    Although these programs are all intended to facilitate the 
collection, analysis and reporting of information about the 
prescribing, dispensing and use of controlled substances, they 
differ in their objectives and operations. They all provide 
data and analysis to State law enforcement and regulatory 
agencies. These agencies use the information to assist in 
identifying and investigating activities potentially related to 
the illegal prescribing, dispensing and procuring of controlled 
substances.
    Further, some programs can be used by physicians to check a 
patient's prescription drug history, to determine if the 
individual was doctor shopping to seek multiple controlled 
substances.
    A few States proactively analyze prescription data 
collected by programs to identify unusual prescribing or 
dispensing patterns that could suggest potential drug 
diversion, abuse or doctor shopping. However, most programs use 
the prescription data in a reactive manner to respond to 
requests for information.
    The operation of the monitoring programs varies primarily 
in terms of the specific drugs they cover. Some programs cover 
only those prescription drugs that are most prone to abuse and 
addiction, generally, Schedule II drugs, whereas, others 
provide more extensive coverage.
    As Representative Rogers noted, we found that State 
monitoring programs helped in State efforts to reduce drug 
diversion. Benefits included improvement in the timeliness of 
law enforcement and regulatory investigations. Each of the 
three States we've studied in greater depth, Kentucky, Nevada, 
and Utah, reduced its case investigation time by at least 80 
percent. In addition, law enforcement officials told us that 
they view the program as a deterrent to doctor shopping, 
because potential diverters are aware that any physician from 
whom they seek a prescription may first examine their 
prescription drug utilization history based on monitoring 
program data.
    For example, as drug diverters became aware of Kentucky's 
ability to trace their drug histories, they tended to move 
their diversion activities to nearby non-monitored States.
    Although monitoring programs can enhance the ability of 
States to detect and deter illegal diversion of prescription 
drugs, the number of States with such programs has grown only 
slightly over the past 12 years, from 10 in 1992 to 16 in 2004. 
A lack of awareness of the magnitude of the problem, concerns 
about confidentiality on the part of patients, physicians, 
pharmacists, and legislators, and difficulty in accessing 
funding, have kept the numbers of monitoring programs low.
    The operational needs of existing programs may also shift 
with other changes in the marketplace. As drug marketing 
practices have changed, and with the advent of Internet 
pharmacies, programs may need to be modified to reflect more 
timely information, initiate more frequent analyses to spot 
trends, or undertake other program enhancements that may entail 
additional costs.
    Mr. Chairman, this concludes my prepared statement. I'd be 
pleased to respond to any questions you or other members may 
have.
    [The prepared statement of Marcia Crosse follows:]

  Prepared Statement of Marcia Crosse, Director, Health Care--Public 
                 Health and Military Health Care Issues

    Mr. Chairman and Members of the Subcommittee: I am pleased to be 
here today and thank you for the opportunity to discuss our work on 
state prescription drug monitoring programs and their use in addressing 
the diversion of prescription drugs for illegal use.
    The increasing diversion of prescription drugs for illegal purposes 
or abuse is a disturbing trend in the nation's battle against drug 
abuse.1 Diversion activities can include ``doctor shopping'' 
by individuals who visit numerous physicians to obtain multiple 
prescriptions, illegal sales of prescription drugs by physicians or 
pharmacists, prescription forgery, and purchasing drugs from Internet 
pharmacies without valid prescriptions. The most frequently diverted 
prescription drugs are controlled substances 2 that are 
prone to abuse, addiction, and dependence,3 such as 
hydrocodone (the active ingredient in Lortab and many other drugs), 
diazepam (Valium), methylphenidate (Ritalin), and oxycodone (the active 
ingredient in OxyContin and many other drugs). According to the Drug 
Enforcement Administration (DEA), increases in the extent of 
prescription drug abuse and in emergency room visits related to 
prescription drug abuse, as well as an increase in the theft and 
illegal resale of prescription drugs, indicate that drug diversion is a 
growing problem nationwide.
---------------------------------------------------------------------------
    \1\ Office of Drug Control Policy, ``U.S. Drug Prevention, 
Treatment, Enforcement Agencies Take on `Doctor Shoppers', `Pill 
Mills','' Mar. 1, 2004, www.whitehousedrugpolicy.gov (downloaded Mar. 
2, 2004).
    \2\ Under the Controlled Substances Act, which was enacted in 1970, 
drugs are classified as controlled substances and placed into one of 
five schedules based on their medicinal value, potential for abuse, and 
safety or dependence liability.
    \3\ According to the National Institute on Drug Abuse, addiction is 
a chronic, relapsing disease, characterized by compulsive drug seeking 
and use and by neurochemical and molecular changes in the brain, 
whereas physical dependence is an adaptive physiological state that can 
occur with regular drug use and results in withdrawal symptoms when 
drug use is discontinued.
---------------------------------------------------------------------------
    Some states operate prescription drug monitoring programs as a 
means to control the illegal diversion of prescription drugs. My 
remarks today will focus on (1) how state monitoring programs compare 
in terms of their objectives and operation and (2) the overall impact 
of state monitoring programs on illegal diversion of prescription 
drugs. My comments are based on our May 2002 report on state monitoring 
programs and their usefulness as a tool for reducing 
diversion.4 For that report we reviewed information from DEA 
and the National Alliance for Model State Drug Laws on the features of 
existing programs. To gain a more in-depth understanding of these 
programs and the challenges they face, we also studied the programs in 
Kentucky, Nevada, and Utah. We selected these three states because at 
the time they had the most recently established programs.
---------------------------------------------------------------------------
    \4\ For more details on these programs, see U.S. General Accounting 
Office, Prescription Drugs: State Monitoring Programs Provide Useful 
Tool to Reduce Diversion, GAO-02-634 (Washington, D.C.: May 17, 2002).
---------------------------------------------------------------------------
    In brief, we found that 15 states operated monitoring programs in 
2002 as a means to control the illegal diversion of prescription drugs 
that are controlled substances.5 Although these programs 
were all intended to facilitate the collection, analysis, and reporting 
of information about the prescribing, dispensing, and use of controlled 
substances, they differed in their objectives and operation. They all 
provided data and analysis to state law enforcement and regulatory 
agencies in order to assist in identifying and investigating activities 
potentially related to the illegal prescribing, dispensing, and 
procuring of controlled substances. Further, some programs could be 
used by physicians to check a patient's prescription drug history to 
determine if the individual may have been doctor shopping to seek 
multiple controlled substances. Some programs also offered educational 
programs for the public, physicians, and pharmacists regarding the 
nature and extent of the problem and medical treatment options for 
abusers of diverted drugs. The operation of the monitoring programs 
varied primarily in terms of the specific drugs they covered and the 
type of state agency in which they were housed. Some programs covered 
only those prescription drugs that are most prone to abuse and 
addiction, whereas others provided more extensive coverage. In 
addition, most programs were administered by a state law enforcement 
agency, a state department of health, or a state board of pharmacy.
---------------------------------------------------------------------------
    \5\ The 15 states were California, Hawaii, Idaho, Illinois, 
Indiana, Kentucky, Massachusetts, Michigan, Nevada, New York, Oklahoma, 
Rhode Island, Texas, Utah, and Washington. In 1998, West Virginia 
terminated its monitoring program, but began operating a program again 
in 2003, bringing the total of state programs to 16. In addition, 
Virginia began operating a pilot program in the southwestern part of 
the state in fall 2003.
---------------------------------------------------------------------------
    We found that state monitoring programs realized benefits in their 
efforts to reduce drug diversion. These included improving the 
timeliness of law enforcement and regulatory investigations. Each of 
the three states we studied reduced its investigation time by at least 
80 percent. In addition, law enforcement officials told us that they 
view the programs as a deterrent to doctor shopping, because potential 
diverters are aware that any physician from whom they seek a 
prescription may first examine their prescription drug utilization 
histories based on monitoring program data. For example, as drug 
diverters became aware of Kentucky's ability to trace their drug 
histories, they tended to move their diversion activities to nearby 
nonmonitored states.

                               BACKGROUND

    The diversion and abuse of prescription drugs are associated with 
incalculable costs to society in terms of addiction, overdose, death, 
and related criminal activities. DEA has stated that the diversion and 
abuse of legitimately produced controlled pharmaceuticals constitute a 
multibillion-dollar illicit market nationwide. One recent example of 
this growing diversion problem concerns the controlled substance 
oxycodone, the active ingredient in over 20 prescription drugs, 
including OxyContin, Percocet, and Percodan. OxyContin is the number 
one prescribed narcotic medication for treating moderate-to-severe pain 
in the United States.6 Currently, a single 20-milligram 
OxyContin tablet legally selling for about $2 can be sold for as much 
as $25 on the illicit market in some parts of Kentucky.
---------------------------------------------------------------------------
    \6\ U.S. General Accounting Office, Prescription Drugs: OxyContin 
Abuse and Diversion and Efforts to Address the Problem, GAO-04-110 
(Washington, D.C.: Dec. 23, 2003).
---------------------------------------------------------------------------
    Combating the illegal diversion of prescription drugs while 
ensuring that the pharmaceuticals remain available for those with 
legitimate medical need involves the efforts of both federal and state 
government agencies. The Controlled Substances Act of 1970 7 
provides the legal framework for the federal government's oversight of 
transactions involving the sale and distribution of controlled 
substances at the manufacturer and wholesale distributor levels. The 
states address these issues through their regulation of the practice of 
medicine and pharmacy.
---------------------------------------------------------------------------
    \7\ Title II of the Comprehensive Drug Abuse Prevention and Control 
Act of 1970 (Pub. L. No. 91-513,  100 et seq., 84 Stat. 1236, 1242 et 
seq.).
---------------------------------------------------------------------------
Controlled Substances Act
    The Controlled Substances Act established a classification 
structure for drugs and chemicals used in the manufacture of drugs that 
are designated as controlled substances.8 Controlled 
substances are classified by DEA into five schedules on the basis of 
their medicinal value, potential for abuse, and safety or dependence 
liability. Schedule I drugs--including heroin, marijuana, and 
hallucinogens such as LSD and PCP--have a high potential for abuse and 
no currently accepted medical use. Schedule II drugs--including 
methylphenidate (Ritalin) and opiates such as hydrocodone, morphine, 
and oxycodone--have a high potential for abuse among drugs with an 
accepted medical use and may lead to severe psychological and physical 
dependence. Drugs on schedules III through V have accepted medical uses 
and successively lower potentials for abuse and dependence. Schedule 
III drugs include anabolic steroids, codeine, hydrocodone in 
combination with aspirin or acetaminophen, and some barbiturates. 
Schedule IV contains such drugs as the antianxiety medications diazepam 
(Valium) and alprazolam (Xanax). Schedule V includes preparations such 
as cough syrups with codeine. All scheduled drugs except those in 
schedule I are legally available to the public with a 
prescription.9
---------------------------------------------------------------------------
    \8\ Section 201, classified to 21 U.S.C.  811.
    \9\ Some schedule V drugs that contain limited quantities of 
certain narcotic and stimulant drugs are available over the counter 
without a prescription.
---------------------------------------------------------------------------
    Under the act, DEA provides legitimate handlers of controlled 
substances--including manufacturers, distributors, hospitals, 
pharmacies, practitioners, and researchers--with registration numbers, 
which are used in all transactions involving controlled substances. 
Registrants must comply with a series of regulatory requirements 
relating to drug security and accountability through the maintenance of 
inventories and records. Although all registrants, including 
pharmacies, are required to maintain records of controlled substance 
transactions, only manufacturers and distributors are required to 
report their transactions involving schedule II drugs and schedule III 
narcotics, including sales to the retail level, to DEA. The data 
provided to DEA are available for use in monitoring the distribution of 
controlled substances throughout the United States, in identifying 
retail-level registrants that received unusual quantities of controlled 
substances, and in investigations of illegal diversions at the 
manufacturer and wholesaler levels. Although data are reported to DEA 
regarding purchases by pharmacies, the act does not require the 
reporting of dispensing information by pharmacies at the patient level 
to DEA.

State Regulation of the Practice of Medicine and Pharmacy
    State laws govern the prescribing and dispensing of prescription 
drugs by licensed health care professionals. State medical practice 
laws generally delegate the responsibility of regulating physicians to 
state medical boards, which license physicians and grant them 
prescribing privileges.10 In addition, state medical boards 
investigate complaints and impose sanctions for violations of the state 
medical practice laws. States regulate the practice of pharmacy based 
on state pharmacy practice acts and regulations enforced by the state 
boards of pharmacy. The state boards of pharmacy are also responsible 
for ensuring that pharmacists and pharmacies comply with applicable 
state and federal laws and for investigating and disciplining those 
that fail to comply. According to the National Association of Boards of 
Pharmacy, all state pharmacy laws require that records of prescription 
drugs dispensed to patients be maintained and that state pharmacy 
boards have access to the prescription records.
---------------------------------------------------------------------------
    \10\ The types of practitioners who prescribe drugs and may be 
monitored by a state program vary among states. Physicians are the 
majority of covered practitioners, but in most states many 
nonphysicians who also have prescribing authority may be covered, 
including physician assistants, dentists, optometrists, podiatrists, 
veterinarians, and certain types of nurses, such as nurse practitioners 
and advanced practice nurses.
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      STATE MONITORING PROGRAMS VARIED IN OBJECTIVES AND OPERATION

    State prescription drug monitoring programs varied in their 
objectives and operation. While all programs were intended to help law 
enforcement identify and prevent prescription drug diversion, some 
programs also included education objectives to provide information to 
physicians, pharmacies, and the public. Program operation also varied 
across states, in terms of which drugs were covered and how 
prescription information was collected. Which agency, such as a 
pharmacy board or public health department, was given responsibility 
for the program also varied across states. Additionally, methods for 
analyzing the data to detect potential diversion activity differed 
among state programs.
    State monitoring programs are intended to facilitate the 
collection, analysis, and reporting of information on the prescribing, 
dispensing, and use of prescription drugs within a state. The first 
state monitoring program was established in California in 1940, and the 
number of programs has grown slowly. We reported that the number of 
states with programs has grown from 10 in 1992 to 15 in 2002; the 
number of programs stands at 16 in 2004.
    We found that state programs varied in their objectives. All states 
used monitoring programs primarily to assist law enforcement in 
detecting and preventing drug diversion, and but some also used the 
programs for educational purposes. Programs assisted law enforcement 
authorities both by providing information in response to requests for 
assistance on specific investigations and by referring matters to law 
enforcement officials when evaluations of program data revealed 
atypical prescribing or dispensing patterns that suggested possible 
illegal diversion. The programs evaluated prescribing patterns to 
identify medical providers who may have been overprescribing and inform 
them that their patterns were unusual. They also identified patients 
who may have been abusing or diverting prescription drugs and provided 
this information to practitioners. For example, the programs in Nevada 
and Utah sent letters to physicians containing patient information that 
could signal potential diversion activity, including the number and 
types of drugs prescribed to the patient during a given time period and 
the pharmacies that dispensed the drugs. Monitoring programs have also 
been used to educate physicians, pharmacies, and the public about the 
existence and extent of diversion, diversion scams, the drugs most 
likely to be diverted by individuals, and ways to prevent drug 
diversion.
    Monitoring programs also differed in operational factors, some of 
which have cost implications. These factors included the choice of 
controlled substance schedules monitored, approaches to analyzing and 
using data, computer programming choices, number and type of staff and 
contractors, turnaround times and report transmittal methods, and 
number and type of requests for information.
    State programs varied in the controlled substances they covered, in 
part because of differences in available resources and other state-
specific factors such as level of drug abuse. Two of the states we 
studied--Kentucky and Utah--covered schedules II through V. These 
states' program officials told us that covering those schedules allowed 
them flexibility to respond if drugs on other schedules became targets 
for diversion. Most experts agree that covering all controlled 
substance schedules prevents drug diverters from avoiding detection by 
bypassing schedule II drugs and switching to drugs in other schedules.
    States used different approaches to analyze the prescription 
information they received. A few states used a proactive approach, 
routinely analyzing prescription data collected by the programs to 
identify individuals, physicians, or pharmacies that had unusual use, 
prescribing, or dispensing patterns that could suggest potential drug 
diversion, abuse, or doctor shopping. Trend analyses were shared with 
appropriate entities, such as law enforcement, practitioners, and 
regulatory and licensing boards. In contrast, most state programs 
generally used the prescription data in a reactive manner to respond to 
requests for information. These requests may have come from physicians 
or from law enforcement or state officials based on leads about 
potential instances of diversion. According to state program officials, 
most programs operated in a reactive fashion because of the increased 
amount of resources required to operate a proactive system.
    Some state programs had electronic reporting systems, while others 
were paper-based. If data are reported electronically, there are 
ongoing computer maintenance and programming choices and their 
attendant costs. Similarly, some state programs engaged private 
contractors to collect and maintain the data, while others did so in-
house. If a private contractor collects the raw data from dispensers 
and converts them to a standardized format, the program pays annual 
contracting costs for database maintenance. Kentucky and Nevada 
privately contracted with the same company to collect data for their 
program databases. Utah, in contrast, collected and maintained drug 
dispensing data in-house, using its own software and hardware.
    The number and type of staff a state chose to operate its 
monitoring program also varied. In 2002, Kentucky's program employed 
four full-time and four part-time staff to help ensure the accuracy of 
its reports, including a pharmacist-investigator who reviewed each 
report before it was sent. Nevada's program operated with one employee 
because a private contractor collected the data. In contrast, in 2002 
Utah's program, with three full-time employees and no private 
contractor, had one program administrator who collected all dispensing 
data, converted them to a standardized format for monitoring, and 
maintained the database. The two other staff answered requests.
    If the program seeks to provide more timely responses to report 
requests, such as same-day responses, the costs involved in returning 
the response to the requester may increase. For example, in 2001 
Kentucky spent up to $12,000 in 1 month for faxing reports. Monitoring 
program officials from Kentucky, Nevada, and Utah told us in 2002 that 
they estimated 3- to 4-hour turnaround times for program data requests, 
and all mainly used faxing, rather than more costly mailing, to send 
reports to requesters. Same-day responses may be preferable for 
physicians who want the prescription drug history for a patient being 
seen that day and for law enforcement users who need immediate data for 
investigations of suspected illegal activity.
    As users become more familiar with the benefits of monitoring 
program report data, requests for information and other demands on the 
programs may increase. In Kentucky, Nevada, and Utah, use had increased 
substantially, mostly because of an increase in the number of requests 
by physicians to check patients' prescription drug histories. In 
Kentucky, these physician requests increased from 28,307 in 2000, the 
first full year of operation, to 56,367 in 2001, an increase of nearly 
100 percent. Law enforcement requests increased from 4,567 in 2000 to 
5,797 in 2001, an increase of 27 percent. Similarly, Nevada's requests 
from all authorized users also increased--from 480 in 1997, its first 
full year, to 6,896 in 2001, an increase of about 1,300 percent.
    Additionally, as drug marketing practices change and monitoring 
programs mature, the operational needs may shift as well. For example, 
states face new challenges with the advent of Internet pharmacies, 
because they enable pharmacies and physicians to anonymously reach 
across state borders to prescribe, sell, and dispense prescription 
drugs without complying with state requirements.11 In 
addition, if users want program reports to reflect more timely 
information, dispensing entities would have to report their data at the 
time of sale, rather than submitting data biweekly or monthly, to 
capture the most recent prescription dispensing. If users want to be 
alerted if a certain drug, practitioner, or pharmacy may be involved in 
a developing diversion problem, programs would have to initiate 
periodic data analysis to determine trends or patterns. Such program 
enhancements would entail additional costs, however, including costs 
for computer programming, and data analysis.
---------------------------------------------------------------------------
    \11\ For more details on Internet pharmacies, see U.S. General 
Accounting Office, Internet Pharmacies: Adding Disclosure Requirements 
Would Aid State and Federal Oversight, GAO-01-69 (Washington, D.C.: 
Oct. 19, 2000).
---------------------------------------------------------------------------
    States that are considering establishing or expanding a monitoring 
program face a variety of other challenges. One challenge is the lack 
of awareness of the extent to which prescription drug abuse and 
diversion is a significant public health and law enforcement problem. 
States also face concerns about the confidentiality of the information 
gathered by the program, voiced by patients who are legitimately using 
prescription drugs and by physicians and pharmacists who are 
legitimately prescribing and dispensing them. Another challenge states 
face is securing adequate funding to initiate and develop the program 
and to maintain and modify it over time.12
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    \12\ Federal grants are available to states to establish new 
monitoring programs and to enhance existing programs under the Harold 
Rogers Prescription Drug Monitoring Program. DEA's Office of Diversion 
Control, in collaboration with the Department of Justice's Bureau of 
Justice Assistance, provides grants to states to establish new programs 
and to enhance existing monitoring programs through the Harold Rogers 
Prescription Drug Monitoring Program. The fiscal year 2003 grantees are 
Alabama, Florida, Maine, New Mexico, and Wyoming for new programs, and 
California, Idaho, Nevada, and New York for enhanced programs. The 
grantees in fiscal year 2002 were Ohio, Pennsylvania, Virginia, and 
West Virginia for new programs, and California, Kentucky, 
Massachusetts, Nevada, and Utah for enhanced programs.
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 STATE MONITORING PROGRAMS HAVE HELPED SHORTEN INVESTIGATION TIMES AND 
                   MAY REDUCE ILLEGAL DRUG DIVERSION

    We found that states with monitoring programs have experienced 
considerable reductions in the time and effort required by law 
enforcement and regulatory investigators to explore leads and the 
merits of possible drug diversion cases. We also found that the 
presence of a monitoring program in a state may help reduce illegal 
drug diversion there, but that diversion activities may increase in 
contiguous states without programs.
    The ability of the programs to focus law enforcement and regulatory 
investigators who are working on suspected drug diversion cases on 
specific physicians, pharmacies, and patients who may be involved in 
the alleged activities is crucial to shortened investigation time and 
improvements in productivity. States that do not have programs must 
rely on tips from patients, practitioners, or law enforcement 
authorities to identify possible prescription drug abuse and diversion. 
Following up on these leads requires a lengthy, labor-intensive 
investigation. In contrast, the programs can provide information that 
allows investigators to pinpoint the physicians' offices and pharmacies 
where drug records must be reviewed to verify suspected diversion and 
thus can eliminate the need to search records at physicians' offices 
and pharmacies that have no connection to a case.
    In each of the three states we studied, state monitoring programs 
led to reductions in investigation times. For example, prior to 
implementation of Kentucky's monitoring program, its state drug control 
investigators took an average of 156 days to complete the investigation 
of alleged doctor shoppers. Following the implementation, the average 
investigation time dropped to 16 days, or a 90 percent reduction in 
investigation time. Similarly, Nevada reduced its investigation time 
from about 120 days to about 20 days, a reduction of 83 percent, and a 
Utah official told us that it experienced an 80 percent reduction in 
investigation time.
    Officials from Kentucky, Nevada, and Utah told us in 2002 that 
their programs may have helped reduce the unwarranted prescribing and 
subsequent diversion of abused drugs in their states. In both Kentucky 
and Nevada, an increased number of program reports were being used by 
physicians to check the prescription drug use histories of current and 
prospective patients when deciding whether to prescribe certain drugs 
that are subject to abuse. Law enforcement officials told us that they 
view these drug history checks as initial deterrents' a front-line 
defense--to prevent individuals from visiting multiple physicians to 
obtain prescriptions, because patients are aware that physicians can 
review their prescription drug history. For an individual who may be 
seeking multiple controlled substance prescriptions, the check allows a 
physician to analyze the prescription drug history to determine whether 
drug treatment appears questionable, and if so, to verify it with the 
listed physicians. In Kentucky, a physician could request a drug 
history report on the same day as the patient's appointment, and 
usually received the report within 4 hours of the request. In 2002, 
Kentucky's program typically received about 400 physician requests 
daily, and provided data current to the most recent 2 to 4 weeks.
    The presence of a monitoring program may also have an impact on the 
prescribing of drugs more likely to be diverted. For example, DEA 
ranked all states for 2000 by the number of OxyContin prescriptions per 
100,000 people.13 Eight of the 10 states with the highest 
numbers of prescriptions--West Virginia, Alaska, Delaware, New 
Hampshire, Florida, Pennsylvania, Maine, and Connecticut--had no 
monitoring programs, and only 2 did--Kentucky and Rhode Island. Six of 
the 10 states with the lowest numbers of prescriptions--Michigan, New 
Mexico,14 Texas, New York, Illinois, and California--had 
programs, and 4--Kansas, Minnesota, Iowa, and South Dakota--did not.
---------------------------------------------------------------------------
    \13\ OxyContin, Hearings Before the Subcommittee on the Departments 
of Commerce, Justice, and State, the Judiciary, and Related Agencies, 
House Committee on Appropriations, 107th Cong. Part 10., pp. 21, 22 
(2001) (Statement of Asa Hutchinson, Administrator of the Drug 
Enforcement Administration).
    \14\ New Mexico's monitoring program was terminated in June 2000.
---------------------------------------------------------------------------
    Another indication of the effectiveness of a monitoring program is 
that its existence in one state appears to increase drug diversion 
activities in contiguous states without programs. When states begin to 
monitor drugs, drug diversion activities tend to spill across 
boundaries to states without programs. One example is provided by 
Kentucky, which shares a boundary with seven states, only two of which 
had programs in 2002--Indiana and Illinois. As drug diverters became 
aware of the Kentucky program's ability to trace their drug histories, 
they tended to move their diversion activities to nearby nonmonitored 
states. OxyContin diversion problems worsened in Tennessee, West 
Virginia, and Virginia--all contiguous states without programs--because 
of the presence of Kentucky's program, according to a 2001 joint 
federal, state, and local drug diversion report.15
---------------------------------------------------------------------------
    \15\ Appalachia High Intensity Drug Trafficking Area Investigative 
Support Center, with the assistance of the National Drug Intelligence 
Center, The OxyContin Threat in Appalachia (London, Ky.: Aug. 2001).
---------------------------------------------------------------------------
                        CONCLUDING OBSERVATIONS

    Although monitoring programs can enhance the ability of states to 
detect and deter illegal diversion of prescription drugs, the number of 
states with such programs has grown only slightly over the past 12 
years from 10 in 1992 to 16 in 2004. A lack of awareness of the 
magnitude of the problem; concerns about confidentiality on the part of 
patients, physicians, pharmacists, and legislators; and difficulty in 
accessing funding have kept the numbers of monitoring programs low. 
Cooperative efforts at the state and national levels are seeking to 
overcome these challenges and increase the number of states with 
programs.
    Mr. Chairman, this concludes my prepared statement. I would be 
pleased to respond to any questions you or other Members of the 
Subcommittee may have.

    Mr. Bilirakis. Thank you. Thank you very much, Ms. Crosse.
    Let's see, Doctor Droz, and from my own State of Florida, 
Tallahassee, welcome to Washington.

                   STATEMENT OF DANNA E. DROZ

    Ms. Droz. Thank you very much, Chairman Bilirakis, members 
of the subcommittee, ladies and gentlemen, I want to tell you 
how much I appreciate the opportunity to be here today speaking 
to you about this timely issue, but one that is hardly new.
    First of all, let me tell you just a little bit about my 
background. I am the President of the National Association of 
State Controlled Substance Authorities. I'm also the Executive 
Director of the Florida Board of Pharmacy. I just assumed that 
position in January. Prior to that, I worked in Kentucky with 
the Drug Enforcement in the Professional Practices Branch, and 
it was the highlight of my career there to be very involved in 
the implementation and development of the KASPER program.
    The National Association of State Controlled Substance 
Authorities, which we abbreviate as NASCSA, is a non-profit 
educational organization in its 20th year. Our members are 
State agencies or State regulators who have an interest in 
regulating controlled substances, but we also have a number of 
associate members, Federal agencies, the drug manufacturers, 
trade associations and others, who meet with us annually in an 
open forum to discuss ways to address the problem of 
prescription drug abuse, but yet make sure that these drugs are 
available to patients.
    Since its inception, NASCSA has recognized the importance 
of prescription monitoring programs, which as Congressman 
Rogers alluded to, has a long history. The first program began 
in 1939 and 1940 in California. It was what we referred to as a 
triplicate prescription program, paper-based, of course, being 
in that time period. The physician wrote a prescription, he 
kept a copy, the pharmacy kept a copy, and a copy went to the 
State. There the data could be used for analysis.
    Over the next 40 years or so, several other States 
developed these triplicate prescription programs. But, because 
of the nature of the paper, they were limited to Schedule II, 
and they were primarily law enforcement-based programs.
    In 1991, Oklahoma wanted to develop a similar program, but 
they recognized that pharmacies were using computers, not only 
to keep records, but also for billing purposes. They sensed 
that there was an opportunity to do something different here, 
and so they developed the first electronic program. Physicians 
wrote the prescriptions, and the pharmacies submitted the data 
to the State, not on paper, but electronically. This made it 
much easier for physicians to prescribe the Schedule II drugs 
that the patients needed, and also it was much easier for the 
pharmacies to record. So, a virtually transparent process 
evolved.
    Over the next 10 years, that paved the way for many other 
States to develop these electronic programs. Today, all of the 
programs in the country collect the data electronically. Now, 
some of them still have special forms that physicians use for 
other purposes, such as preventing forgery, but the paper is 
not used to collect the data.
    In 1995, NASCSA, along with the Alliance of States With 
Prescription Monitoring Programs, developed the first Model 
Prescription Drug Monitoring Program Act. The purpose of this 
was to provide guidance to States who wanted to develop a 
program to set some standards so that there would be some 
commonality among these programs.
    The members of NASCSA recognized that the drugs involved 
are approved to treat medical conditions. While they have the 
potential to produce abuse or even addiction, they are 
absolutely necessary to alleviate pain and treat certain other 
medical conditions.
    Because of the importance of pain management, between 1998 
and 2001 NASCSA passed three resolution supporting the 
educational programs for practitioners, pharmacists and other 
healthcare providers to increase their awareness and their 
ability to appropriately use controlled substances.
    In 2002, NASCSA and the Alliance again collaborated on a 
new prescription monitoring program model act. The need for 
this program was because of changes in technology, more State 
pat programs, there were more issues to be addressed. But yet, 
the goals of the monitoring programs remained the same.
    And, I want to tell you what those goals are, but now 
remember that not every State has all of these goals. States 
focus their programs and their goals depending on their 
individual needs.
    Education and information is one of the goals of 
prescription monitoring programs. Healthcare practitioners, as 
a group, receive very little training about the appropriate use 
of controlled substances, but prescription monitoring programs 
provide an ideal platform for providing more education to these 
groups to enable them to provide better treatment for patients.
    The States that use their program primarily for education 
and information for healthcare practitioners report that the 
most of the users are physicians. When I was in Kentucky, 85 
percent of all the requests for information that we got came 
from physicians, and they reported to us that this information 
was absolutely essential to them. It gave them a sense of 
regaining control over their practice. It enabled them to do 
some things in a much more efficient manner than they had 
previously. A couple of physicians told me that they hired a 
person in their office to do nothing but contact pharmacies and 
check on various patients' prescription drug histories. With 
KASPER, they were able to get this information much more 
quickly, and much more efficiently, and cover a much wider 
area.
    Kentucky, Nevada, and Utah are recognized as the States 
that tend to focus more on healthcare practitioners than some 
of the others, and all three of those States report very high 
use by physicians.
    Mr. Bilirakis. Please summarize, if you would, Ms. Droz.
    Ms. Droz. Yes, sir.
    The other goals are public health initiatives, such as 
analyzing the data, allowing physicians to intervene and 
prevent drug abuse and addiction in patients, and then also 
providing a tool for investigations and enforcement to use when 
patients or physicians do things that are against the law.
    The States always recognize the importance of maintaining 
confidentiality. The variability in State programs is 
recognized by the members of NASCSA, but the key is balance. 
It's possible to create a program that will absolutely prevent 
all diversion, but if you do that patients will suffer. It's 
possible to make drugs so accessible that patients can get 
everything that they need but diversion will be rampant.
    Mr. Bilirakis. I'm sorry, your time is well up, but yet I 
know you have more. But, I think during the questions and 
answers you'll be able to get a few of those points across. I 
apologize for that.
    Ms. Droz. I apologize profusely. As you can tell, this is 
one of my passions, and I'm normally speaking for much longer 
than this, and I'm having trouble. I apologize again.
    Mr. Bilirakis. And, if it were Doctor Norwood giving your 
presentation, as slowly as he speaks, it probably would have 
taken an extra 2 minutes.
    Mr. Norwood. You are talking about these girls from 
Tallahassee, I grew up in Austin.
    [The prepared statement of Danna E. Droz follows:]

Prepared Statement of Danna E. Droz, President, National Association of 
                 State Controlled Substance Authorities

    NASCSA supports the Harold Rogers Grants for Prescription 
Monitoring programs and recommends continued financial support and 
consideration of a federal mandate for states to develop prescription 
monitoring programs.
    Chairman Bilirakis, members of the Subcommittee, Ladies and 
Gentlemen, good afternoon. Thank you for the opportunity to speak with 
you today about topics that are very timely but hardly new, 
particularly to our members--abuse of prescription drugs and 
prescription monitoring programs.
    I represent the National Association of State Controlled Substance 
Authorities (hereinafter NASCSA). NASCSA is a non-profit educational 
organization, celebrating its twentieth anniversary this year. 
Currently we have 42 member states, although many other people and 
organizations are associate members or otherwise active in the 
organization. The primary purpose is to provide a continuing mechanism 
through which state agencies, federal agencies, the regulated 
industries and professions, and others can work to increase the 
effectiveness and efficiency of state and national efforts to prevent 
and control drug abuse, yet provide mechanisms to make the class of 
drugs known as controlled substances reasonably available to those 
persons who have a true medical need for these drugs. This is 
accomplished by providing a neutral forum during the fall conference of 
each year, for the exchange of ideas, information, and views on legal 
and regulatory issues relating to the controlled substances.
    The issue of prescription monitoring programs has been a focus of 
NASCSA since its inception. Some of the first conferences of NASCSA in 
the early 1980's included sessions on prescription monitoring, a 
practice that continues to this day.
    Abuse of prescription drugs and efforts to monitor those drugs has 
existed almost as long as prescription drugs. In 1939-1940, California 
implemented the first prescription monitoring program by requiring that 
any physician who wrote a prescription for a Schedule II drug, such as 
morphine or Demerol( had to use a special three-part form. The 
physician retained a copy, the pharmacy retained a copy and one copy 
was sent to the state. The information was then available for analysis 
to determine if physicians or patients might be misusing or abusing 
these drugs. Over the next 40 years or so, several other states adopted 
similar programs which were often referred to a ``triplicate 
prescription programs.''
    In 1991, Oklahoma developed a similar program. However, instead of 
collecting data on paper, they recognized that the pharmacy industry 
was using computers to transfer prescription information for billing 
purposes. Sensing an opportunity, the state officials developed the 
first electronic prescription monitoring program. The same data was 
collected but no pieces of paper were involved. This made it much 
easier for physicians to prescribe Schedule II controlled substances 
and for pharmacists to report the required information to the state. A 
virtually transparent process evolved. Over the next ten years, several 
more states developed electronic monitoring programs and expanded from 
schedule II only to all controlled substances. The states that formerly 
required triplicate prescription blanks have now converted to 
electronic data collection of prescription information. (Note: Some of 
the states still utilize special or state-issued prescription blanks 
but not for data collection purposes.)
    In 1995, NASCSA and the Alliance of States with Prescription 
Monitoring Programs (hereinafter Alliance of States), a sister 
organization, developed and adopted the first Model Act for 
Prescription Monitoring Programs. This document served to guide states 
in developing new programs but allowed sufficient latitude for each 
state to make modifications to address various state-specific needs. 
Today we have about 22 states with programs in operation or currently 
being implemented.
    The members of NASCSA have always recognized that prescription 
controlled substances are first and foremost, prescription drugs that 
are approved to treat medical conditions. While they inherently possess 
the potential to be abused or produce addiction, these drugs are 
absolutely necessary to alleviate pain and treat certain other 
conditions. Recognizing the importance of appropriate pain management, 
between 1998 and 2001, NASCSA members adopted three different 
resolutions reiterating their support for the appropriate use of 
controlled substances and encouraging increased education for 
practitioners, pharmacists, and other health care providers surrounding 
the appropriate use of prescription controlled substances for treating 
patients with legitimate medical conditions.
    In 2002, NASCSA and the Alliance of States again collaborated on a 
new model act, the ``Prescription Monitoring Program Model Act of 
2002.'' This document addressed many of the changes in technology and 
needs recognized by states with current programs. However, the goals of 
prescription monitoring programs remained the same:

 Education and information--Health practitioners, as a group, receive 
        very little training about appropriate use of controlled 
        substances. Prescription monitoring programs provide an 
        excellent platform for various groups to offer educational 
        opportunities for such learning.
      Practitioners in those states that have programs report that the 
        additional information about patients' drug histories is 
        invaluable in evaluating medical conditions where the 
        prescribing of controlled substances is being considered.
 Public health initiatives--Analyzing trends and sudden changes in 
        prescribing or dispensing patterns can provide valuable 
        information that may alert officials to potential diversion 
        before it becomes an epidemic.
 Early intervention and prevention--Physicians and pharmacists who 
        review a patient's history of prescription controlled 
        substances have an opportunity to recognize the warning signs 
        of abuse or addiction. These patients can be steered into 
        intervention programs or referred to treatment programs earlier 
        in the abuse/addiction disease process, possibly saving 
        thousands of health care dollars that would otherwise be 
        required.
 Investigations and enforcement--Crimes involving prescription drugs 
        require very different investigative and evidence gathering 
        techniques than those used to investigate street drug crimes. 
        The information available from a prescription monitoring 
        program can be a tool for gathering evidence by allowing an 
        officer to focus his/her investigation on locations where 
        evidence is most likely to be located. Please note that data 
        from a program does not replace the investigation; it merely 
        decreases the time required to gather evidence.
 Protection of confidentiality--Every state with a prescription 
        monitoring program has very strict parameters about who can get 
        access to the data, the purposes for which it can be used, and 
        with whom the information may be shared. While the parameters 
        vary from state to state, each one recognizes the confidential 
        nature of the information and the necessity of minimal 
        disclosure.
    It is worth noting that NASCSA members recognized the importance of 
patient privacy long before HIPAA required it. A person's prescription 
information should be available only to those persons with a legal 
need-to-know.
    Today the variability in state programs is significant. Each 
program is developed and implemented because of specific needs, 
interests, and compromises within the individual state. Yet each 
program also works because it meets many, but not all, of the needs of 
the agencies and persons who utilize the program. While it would be 
possible to develop a program that absolutely prohibited misuse or 
diversion, many legitimate patients would be denied access to the drugs 
that make their lives worth living. On the other hand it would be 
possible to make prescription controlled substances easily available to 
every person who might potentially benefit from their use. Yet such a 
system would be fraught with drug diversion. The key is balance. 
Prescription Monitoring Programs attempt to strike the appropriate 
balance between making drugs available for patients and limiting drug 
diversion.
    I'd like to review the various programs currently in place or being 
implemented across the country.
    Schedules of drugs monitored--Many of the states that initially had 
paper-based programs using state-issued prescription blanks monitor 
only schedule II drugs such as Demerol ', Dexedrine 
', morphine, OxyContin ', Percocet ', 
Ritalin ', Tylox ', and all of their generic 
equivalents. Other states have expanded to Schedules II, and III, which 
would cover the Lorcet ', Lortab ', Tylenol 
' with codeine and Vicodin ' and equivalents. 
Those states that monitor Schedules II, III, and IV include all of the 
above mentioned drugs plus many of the diet pills like Adipex 
' and the anti-anxiety agents like Valium ' and 
Xanax '. Three states, Kentucky, Michigan, and Utah, monitor 
all the controlled substances. While the use and abuse of schedule V 
drugs is not nearly as voluminous as in Schedules II, III, and IV, it 
does occur. Those states feel that it is very difficult for a state, 
having once implemented a limited program, to amend its laws to expand 
it. Furthermore, one never knows what new drug will appear in the 
marketplace and how it will be scheduled. Often the abuse potential is 
not recognized at the outset. Some of you may recall that many of our 
problem drugs of today were hailed at product launch as having no abuse 
potential. Even some of our over-the-counter drugs are being abused and 
causing deaths in young people.
    What agency operates the program--Some states house their 
prescription monitoring program in a health program agency, some in a 
law enforcement agency and some in a pharmacy board or similar 
licensing agency. Where the program is located is often a function of 
the types of people that utilize the data and what purpose the program 
was implemented to address. Those states that house the program in a 
health agency generally use the data for health purposes such as 
providing information to physicians or pharmacists who are treating 
patients or health licensing boards that are investigating complaints 
against health care practitioners. If the program is housed in a law 
enforcement agency, the state tends to focus on prescription forgery, 
``doctor-shopping'', or other patient focused crimes.
    How frequently is data updated--Currently all states utilize a 
reporting process called batch reporting. States require pharmacies to 
report the prescriptions for controlled substances on a regular basis 
ranging from every week to every month. While everyone recognizes the 
limitations of batch reporting, it is still the most cost-effective way 
to collect this type data. Of course real-time reporting is preferable 
but there are significant hurdles to overcome, not the least of which 
is cost. It is also important to note that Oklahoma used real-time 
reporting when their program was initially implemented. However, they 
abandoned it in favor of batch reporting because they found that its 
limited value was not worth the cost. In addition, there were 
technological problems that prevented the data from entering the 
database as quickly as they had hoped. At this point in time, real-time 
reporting of prescription data is a simple concept, but it is very 
difficult to implement. While I was working in Kentucky, we worked with 
groups of physicians as well as law enforcement officers. The consensus 
was that batch reporting of data will meet 85-90% of their needs. In 
the words of Dr. Steve Davis, my former supervisor, we have to make 
sure ``the juice is worth the squeeze.''
    Who has access to the information--States have different concepts 
of who has a need for patient-specific prescription information. Some 
states limit access to this information to a specific law enforcement 
agency, some to only law enforcement agencies, some to health care 
providers, including pharmacists, and some to only physicians. Access 
by licensing boards that discipline health care practitioners are 
sometimes considered law enforcement and sometimes health care.
    Sharing across state lines--All NASCSA members recognize that 
prescription drug abuse has no boundaries. Patients and providers alike 
frequently cross state lines for a multitude of reasons, most of them 
legitimate. Some states are able to share the information contained in 
prescription monitoring program data bases while others are not. The 
2002 Prescription Monitoring Program Model Act supports the appropriate 
sharing of information between states. Many of the states, who cannot 
share information at the present time, are seeking to amend their laws 
to include this capability.
    In 2003, NASCSA convened a workgroup composed of representatives 
from states with prescription monitoring programs, DEA's Drug Diversion 
group, pharmacies, third party payers and drug manufacturers. The goal 
of this group was to develop standards for reporting prescription 
information to such programs. The group felt that if every state 
required the same information to be reported, it would facilitate:

(a) sharing information from one state to another and
(b)compliance by corporations with pharmacies in multiple states.
    These reports, as well as other documents that I have referred to 
in my testimony are available on NASCSA's website at www.NASCSA.org.
    In summary, NASCSA members support the concept of prescription 
monitoring programs and recognize the problems associated with a state-
by-state implementation process. However, there are significant issues 
associated with a national data base for prescription monitoring 
purposes. Therefore NASCSA has passed a resolution both in 2002 and 
2003 supporting the Harold Rogers Grant programs for states seeking 
legislation for a prescription monitoring program, implementing a new 
program or enhancing an existing program. It is the position of NASCSA 
that a federal program would be duplicative of the states efforts, have 
the unintended consequence of providing a disincentive to states to 
continue their programs, and limit the ability of the states to address 
unique problems. NASCSA members believe that prescription monitoring 
programs would be more effectively supported by Congress' financial 
support and possibly a mandate for all states to develop such programs 
with standard features that would facilitate sharing data among the 
states.
    We would like to thank members of this committee for permitting me 
to testify on behalf of NASCSA on this very important issue which our 
members have been working on collectively for years. We look forward to 
collaborating with Committee members and your staff on this issue. 
Since many of our members have years of experience in the issue of 
prescription drug abuse and prescription monitoring programs, we 
believe we are uniquely qualified by this experience to serve as a 
vital voice in this debate. I would be happy to answer questions you 
might have.

    Mr. Bilirakis. Doctor Holsinger.

              STATEMENT OF JAMES W. HOLSINGER, JR.

    Mr. Holsinger. Well, Mr. Chairman, it's a real pleasure 
once again to be in front of you at a committee hearing. It's 
been over a decade since we've had a chance to do this, and I 
really appreciate the opportunity to be here. It's amazing how 
fast time flies.
    It's also a great pleasure for me to have been able to sit 
at the same witness table with the Dean of the Congressional 
Delegation from Kentucky, Congressman Hal Rogers, who, as you 
know, has worked diligently in the Commonwealth of Kentucky and 
across the country here in Congress to reduce the abuse of 
prescription drugs, and, obviously, I want to thank Congressman 
Ed Whitfield for all of his support, as he has also been 
passionate about reducing the abuse of prescription drugs.
    I think it's rather interesting, if you look at this 
witness table, I'm not quite sure where Ms. Crosse has been in 
her career, but if she's been in Kentucky it's an all Kentucky 
cast. This is a group of people that have one time or another 
throughout the past few years been intimately involved in 
dealing with this particular issues.
    I'd like to tell you briefly about KASPER. KASPER is the 
acronym for the Kentucky All Schedule Prescription Electronic 
Reporting program. This system automated the processing of data 
to support the tracking and sharing of information in 
accordance with existing statutes governing controlled 
substance prescriptions.
    It was enacted into law during the 1998 legislative session 
following the recommendation of a task force that was chaired 
by Dr. Rice Leach, Commissioner for Public Health for the 
Commonwealth of Kentucky, and made up of representatives of 
many groups in the State with a stake in controlled substance 
diversion issues. Even today KASPER is considered in our 
Commonwealth to be a public health initiative.
    In addition to authorizing KASPER, the 1998 legislation 
made other changes to the controlled substance act including 
permission for the cabinet to share prescription information 
with providers and law enforcement agencies under specific 
circumstances, the mandatory use of security prescription 
blanks for all controlled substance prescriptions, and the 
theft of a security prescription blank became a felony offense.
    KASPER did not add any authority the State did not already 
have to monitor scheduled drug prescriptions. KASPER's purpose, 
like that of any tool, is to increase productivity of 
individuals with the task of administering the controlled 
substance act.
    A comprehensive program like KASPER, in conjunction with 
Kentucky's other controlled substance statutes, is necessary 
because the diversion of controlled substances is at epidemic 
levels. Since individuals involved in drug diversion cover 
large geographic areas to obtain drugs, the agencies charged 
with controlling the problem needed a tool that would add value 
to their investigative efforts.
    The two main goals of the statutes that created KASPER are 
first, to be a source of information for physicians and 
pharmacists and to be an investigative tool for law 
enforcement. KASPER is the tool that enables this information 
to be collected, analyzed, and shared rapidly.
    KASPER allows the State to capture dispensing information 
on Schedules C-II, III, IV, and V drugs electronically in a 
relational data base.
    Data gets into the relational data base as dispensers 
transmit prescription data to our data collection agent by 
modem, diskette or tape. The data collection agent then 
verifies, compiles and sends the data to the Drug Enforcement 
and Professional Practices Branch in the Department for Public 
Health to be loaded onto the secure KASPER server.
    Very high security procedures protect access to the data, 
with only Branch personnel having access to information within 
the KASPER data base. Report requesting by authorized 
individuals also undergoes a high level of scrutiny. Release of 
data to anyone not authorized by Kentucky statute is a class D 
felony.
    Kentucky's KASPER statute allows a report to be obtained by 
a grand jury subpoena, by a prescriber for medical treatment, 
by a pharmacist for pharmaceutical treatment, by law 
enforcement officers with a bona-fide investigation, by 
professional licensing boards investigating a license, and it's 
important to realize that, and by Medicaid programs for a 
recipient and by a court order from a judge of competent 
jurisdiction.
    As a result of KASPER, State reporting productivity, as has 
been already mentioned, has rather dramatically, 30 fold, 
originally, the first year there were only 3,000 reports 
requested, but now there are 110,000 reports that are requested 
annually, and 85 percent, as mentioned earlier by Ms. Droz, are 
from physicians. The investigative productivity has improved 5 
fold in 5 years. Prior to KASPER, the drug enforcement officers 
took about 100 days to complete an investigation, now it is 
less than 20.
    Many of the clinicians in the State were skeptical when 
KASPER was initiated. They felt the scrutiny implied by a 
monitoring program would interfere with their practice. In 
actuality, they have found that by utilizing the program to 
monitor their patients chronically utilizing controlled 
substances they have documentation to prove they are treating 
these patients judiciously.
    Even the Kentucky Board of Medical Licensure has included 
the use of KASPER reports in its standards of practice 
guidelines for chronic pain management.
    Prior to the ready availability of KASPER reports, law 
enforcement personnel would receive a complaint, then use a 
very detailed process in order to spread out and come to a 
conclusion as to where the problem was arising from. The 
information from KASPER, though, has drastically improved the 
investigative routine for law enforcement officers. They 
receive a complaint, request a KASPER report, they know 
immediately whether prescriptions were filled and the physician 
that wrote the prescription.
    The results generated by the KASPER data have been so well 
received the State legislature saw fit to make funding 
available to enhance the program. In an effort to address the 
biggest complaint with KASPER, which was a 4-hour report 
turnaround time, the enhanced system will be web based allowing 
requesters to receive a majority of their reports within 15 
minutes, with the ultimate goal of becoming a real-time 
program. These and other additional enhancements are also being 
studied as funding for these projects becomes available.
    I want to thank the chairman and committee members for 
allowing me today to come and tell you about a program that we 
believe is a model for the Nation, KASPER.
    Thank you.
    [The prepared statement of James W. Holsinger, Jr. 
follows:]

Prepared Statement of James W. Holsinger, Jr., Secretary of the Cabinet 
        for Health and Family Services, Commonwealth of Kentucky

    Chairman Bilirakis, members of the Committee, thank you for 
allowing me the opportunity to come and testify this afternoon. I also 
want to thank and recognize Congressman Hal Rogers, who we 
affectionately refer to as the Dean of the Kentucky delegation, for all 
of his hard work to reduce the abuse of prescription drugs. I also want 
to thank Congressman Ed Whitfield who is passionate about wanting to 
work towards reducing the abuse of prescription drugs in the 
Commonwealth and beyond.
    KASPER is the acronym for the Kentucky All Schedule Prescription 
Electronic Reporting program. This system automated the processing of 
data to support the tracking and sharing of information in accordance 
with existing statutes governing controlled substance prescriptions.
    KASPER was enacted into law during the 1998 legislative session 
following the recommendation of a task force chaired by Dr. Rice Leach, 
Commissioner for Public Health for the Commonwealth, and made up of 
representatives of many groups in the state with a stake in controlled 
substance diversion issues. Even today KASPER is considered a public 
health initiative.
    In addition to authorizing KASPER, the 1998 legislation made other 
changes to the controlled substance act including permission for the 
cabinet to share prescription information with providers and law 
enforcement agencies under specific circumstances, the mandatory use of 
security prescription blanks for all controlled substance 
prescriptions, and the theft of a security prescription blank became a 
felony offense.
    KASPER did not add any authority the state did not already have to 
monitor scheduled drug prescriptions. KASPER's purpose, like that of 
any tool, is to increase productivity of individuals with the task of 
administering the controlled substance act.
    A comprehensive program like KASPER, in conjunction with Kentucky's 
other controlled substance statutes, is necessary because the diversion 
of controlled substances is at epidemic levels. Since persons involved 
in drug diversion cover large geographic areas to obtain drugs the 
agencies charged with controlling the problem needed a tool that would 
add value to their investigative efforts.
    The two main goals of the statutes that created KASPER are: to be a 
source of information for physicians and pharmacists and to be an 
investigative tool for law enforcement. KASPER is the tool that enables 
this information to be collected, analyzed, and shared rapidly.
    KASPER allows the state to capture dispensing information on 
schedules C-II, III, IV, and V drugs electronically in a relational 
database.
    Data gets into the relational database as dispensers transmit 
prescription data to our data collection agent by modem, diskette or 
tape. The data collection agent then verifies, compiles and sends the 
data to the Drug Enforcement and Professional Practices Branch in the 
Department for Public Health to be loaded onto the secure KASPER 
server.
    Very high security procedures protect access to the data with only 
Branch personnel having access to information within the KASPER 
database. Report requesting by authorized individuals also undergoes a 
high level of scrutiny. Release of data to anyone not authorized by 
Kentucky statute is a class D felony.
    Kentucky's KASPER statute allows a report to be obtained by a grand 
jury subpoena, by a prescriber for medical treatment, by a pharmacist 
for pharmaceutical treatment, by law enforcement officers with a bona-
fide investigation, by professional licensing boards investigating a 
licensee, by Medicaid programs for a recipient and by a court order 
from a judge of competent jurisdiction.
    As a result of KASPER, state reporting productivity has increased 
30 fold* and investigation productivity has improved 5 fold** in 5 
years.
    Many of the clinicians in the state were skeptical when KASPER was 
initiated. They felt the scrutiny implied by a monitoring program would 
interfere with their practice. In actuality they have found that by 
utilizing the program to monitor their patients chronically utilizing 
controlled substances they have documentation to prove they are 
treating these patients judiciously.
    Even the Kentucky Board of Medical Licensure has included the use 
of KASPER reports in its standards of practice guidelines for chronic 
pain management.
    Prior to the ready availability of KASPER reports, law enforcement 
personnel would receive a complaint, then use a ``spiral out'' approach 
visiting pharmacies to determine if the suspect had purchased 
controlled substances at that location. When they found a number of 
records they would then visit the physicians involved to get 
statements. In a highly populated area this could involve a large 
number or pharmacies. In rural areas this could involve going to 
several counties.
    The information available from KASPER has drastically improved the 
investigative routine for law enforcement officers. They receive a 
complaint, request a KASPER report and know immediately where the 
prescriptions were filled and the doctor that wrote the prescription.
    The results generated by the KASPER data have been so well received 
the state legislature saw fit to make funding available to enhance the 
program. In an effort to address the biggest complaint with KASPER, 
which was a four hour report turn around time, the enhanced system will 
be web based allowing requestors to receive a majority of their reports 
within 15 minutes with the ultimate goal of becoming a real-time 
program. These and other additional enhancements are also being studied 
as funding for these projects becomes available.
    I want to thank the Chairman and Committee members for allowing me 
to come and testify.

    Mr. Bilirakis. Thank you very much.
    Doctor Manchikanti.

               STATEMENT OF LAXIMAIAH MANCHIKANTI

    Mr. Manchikanti. Mr. Chairman, members of the committee and 
staff, I would like to thank you on behalf of the American 
Society of Interventional Pain Physicians for giving us this 
opportunity to present our views.
    ASIPP is an organization representing interventional pain 
physicians and other professionals involved in interventional 
pain management. Interventional pain management is a discipline 
of medicine devoted to the diagnosis and treatment of pain 
related disorders, principally with the application of 
interventional techniques in managing subacute, chronic, 
persistent, and intractable pain, independently or in 
conjunction with other modalities of treatment. As 
interventional pain physicians, our members are involved 
extensively in prescribing controlled substances.
    I have provided the committee with a great deal of 
information on a multitude of issues facing substance abusing 
generally and prescription drugs in particular. During the next 
few minutes, I would like to discuss personal experiences on 
specific issues relating to chronic pain and prescription 
drugs.
    Today, chronic pain requiring some type of treatment is 
estimated in 15 to 30 percent of the population. 
Psychotherapeutic drugs, which include pain relievers, 
tranquilizers, stimulants, and sedatives, were the second 
leading category of illicit drug use in 2002, following 
marijuana.
    However, what is not appreciated is that misuse of these 
drugs in the chronic pain population, recent surveys have shown 
that approximately 18 percent to 24 percent of the chronic pain 
patients in well-managed settings with medical necessity 
assessment, controlled substance agreements, KASPER and random 
drug testing do abuse these drugs.
    In addition, illicit drug use among this population ranges 
from 14 percent to 32 percent. This, essentially, translates 
into an additional 5 to 10 million persons misusing 
prescription drugs or using illicit drugs.
    While pharmaceuticals can be diverted in multiple ways, the 
most popular form of diversion and point of prevention is 
doctor shopping. The most alarming form of drug abusing was, 
not only Schedule II drugs, but also Schedule III and IV drugs.
    State monitoring programs are extremely useful in 
preventing the drug diversion--that is at the doctor's office 
or at the pharmacy. KASPER is a helpful program for Kentucky 
physicians. However, if a patient is not from Kentucky, or not 
purchasing drugs in Kentucky, KASPER is not useful.
    As an example, I had a patient from Illinois. He was a 
Vietnam veteran, had five back surgeries, and, obviously, 
needed medical treatment. He presented all the right 
information, we were very diligent, and we did a random drug 
testing, which was appropriate. However, we were not able to 
get a past drug information on him because he was from 
Illinois.
    After a few minutes, I was just walking by the operating 
room, one of the other patients asked me to talk to him. He 
told me that this patient that I referred to previously has 
been selling OxyContin and has been bragging about it, that he 
was making $10,000 a month by selling these drugs.
    So, I went and confronted him. He denied everything, of 
course.
    We contacted the pain center, and the dramatic information 
was that they were not giving him OxyContin, but they were 
giving him morphine.
    So, we contacted four other offices, at that time we found 
that one of the physicians was giving OxyContin, 80 milligrams 
three times a day. The same patient, in this process, we found 
that went and had another block at another office just a month 
before, so that he could get the medicine.
    As you know, I cannot get information if a patient is from 
a different State. For example, in Kentucky we evaluate 1,000 
patients in my practice, we were not able to get information on 
26.6 percent of the patients.
    If they were from Kentucky it was 10 percent, but if they 
were from Illinois, Tennessee or Missouri, it was much higher.
    National drug control policy is going to spend over $12 
billion in 2005 on this issue. Medicaid is expected to spend 
almost $9 billion to purchase these drugs for recipients, 
because it is ideal and in the best interest of the public to 
have a comprehensive strategy to control drug abuse that it is 
ordering by appropriate monitoring systems, by means of either 
NASPER or the regional system which will have access to data 
for physicians from all the surrounding States.
    A good prescription monitoring program will enable 
physicians to provide optimal care and the patient will receive 
appropriate and timely care. This is exemplified by the fact 
that in the past we used to inquire of our patients drug 
history by calling each doctor's office in Kentucky, now we 
just get a KASPER report and look at it and provide the proper 
care.
    If we do not have the proper information, we won't be able 
to provide the same quality of care. The same thing still 
happens with Illinois, Tennessee and Missouri patients. I have 
had instances where I was forced to send patients home, while 
awaiting on a reliable drug profile.
    Thank you.
    [The prepared statement of Laximaiah Manchikanti follows:]

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    Mr. Bilirakis. Thank you very much, Doctor.
    Doctor, you are the President and Executive Director of the 
society, right?
    Mr. Manchikanti. That's correct.
    Mr. Bilirakis. Society of Interventional Pain Physicians.
    You also practice medicine in the pure sense, by that I 
mean you have an office?
    Mr. Manchikanti. Yes, an active practice.
    Mr. Bilirakis. Active practice.
    You can tell us then, I think, if there is a drug 
monitoring system and implementation, are there additional 
requirements on physicians, an additional burden to physicians?
    Mr. Manchikanti. No.
    Mr. Bilirakis. There are not?
    Mr. Manchikanti. None.
    Mr. Bilirakis. How often do you request prescription drug 
histories of your patients?
    Mr. Manchikanti. We request close to--from our Paducah 
office, which is in Kentucky, about 6,000 of them every year.
    Mr. Bilirakis. All right. Well, does that mean you request 
it of every one of your patients?
    Mr. Manchikanti. Yes, and every 6 months.
    Mr. Bilirakis. Every 6 months.
    Mr. Manchikanti. That's correct.
    Mr. Bilirakis. I see.
    Is that--how does that compare with the way most 
physicians, in your opinion, practice?
    Mr. Manchikanti. It all depends on individual experiences, 
but most physicians are becoming very careful. I'm also a 
member of Kentucky Board of Medical Licensure, so we are seeing 
more and more physicians adapting the same principle.
    Mr. Bilirakis. Is the information that you are acquiring 
from the patients generally accurate?
    Mr. Manchikanti. Ninety percent of the time it is accurate.
    Mr. Bilirakis. What, again, and I'm not trying to simplify 
the problem, because God knows it isn't simple, but who is at 
fault here? I realize that, you know, people are in pain, and 
who is at fault? Why is this such a big problem?
    Mr. Manchikanti. Well, I had a section in there, 
pharmaceutical companies are providing marketing and--There are 
numerous organizations providing guidelines and standards that 
our patient advocacy groups are demanding opiates for benign 
pain. Everybody looks at Internet and comes and says, oh, I can 
have that medicine.
    Then, enactment of patients' bill of rights in many 
States--or regulations mandating monitoring in the proper 
treatment of pain, and patients think they have the right to 
pain relief.
    Mr. Bilirakis. Doctor Holsinger. I'd like to have maybe all 
of you answer that.
    Mr. Holsinger. Well, I think, Mr. Chairman, that the fault, 
perhaps, lies rather broadly across our society. I think that 
we are bombarded by television with advertising for substances, 
drugs, pharmaceutical agents. We have physicians that are 
constantly barraged by information about new pharmaceutical 
agents. There's such a huge number of pharmaceutical agents, 
and I suspect that very few of us physicians adequately use 
more than 30 to 40 different pharmaceutical agents in their 
practice.
    I mean, you just can't know the medications that well, 
that's why we turn to our friends, the clinical pharmacists, to 
provide us assistance. In fact, today, I think if I were in a 
private practice of medicine I wouldn't practice without a 
clinical pharmacist as part of my practice team. I need that 
kind of support in order to be able to deal with the 
pharmaceutical agents that we are constantly dealing with.
    And, I think that it's a multi-faceted problem, and our 
best hope is to deal with it on a multi-faceted approach. I 
think KASPER, NASPER, some form of effort to deal with the 
diversion of controlled substances is helpful. It helps to deal 
with the front door, in a sense, getting them out of the system 
and onto the street, but I think that it's going to take a lot 
of work on everyone's part to really make a dent in it.
    Mr. Bilirakis. Ms. Droz.
    Ms. Droz. It's a very complex problem, and I think Doctor 
Holsinger and Doctor Manchikanti have covered the range of 
causes.
    Mr. Bilirakis. Ms. Crosse, do you have anything to add?
    Ms. Crosse. I believe they talked about the difficulties.
    Mr. Bilirakis. Well, there are two pieces of legislation 
here that we are talking about. Mr. Whitfield introduced his, 
and Doctor Norwood, more recently. There are some differences 
there, and I'm sure when their opportunity comes they will ask 
you the questions.
    But, very quickly, does anyone have anything significant 
you may want to say regarding those pieces of legislation?
    Mr. Manchikanti. Well, I'm in support of NASPER, and 
Congressman Ed Whitfield is from--I'm in his district, and 
Doctor Shimkus, Mr. Shimkus.
    We came up with this idea because KASPER was working so 
well, but we were not able to obtain information from other 
States. So, the next step was the NASPER, having a national 
program. So, the fundamental thing is, we need a workable 
program, which will be able to share the data when a physician 
inquires about a patient when I'm in Kentucky, he goes to 
California, Florida, or Georgia, wherever he gets the 
medicines, a physician should have access to that.
    If that is achieved, and the program is mandated so it is 
uniform across the States, then they more or less need to have 
a minimum standard that is acceptable. There should not be any 
difference whether it's a State or national program.
    Mr. Bilirakis. Thank you, Doctor.
    My time is up.
    Mr. Brown.
    Mr. Brown. Thank you, Mr. Chairman.
    I'd ask unanimous consent to enter in the statement of Mr. 
Dingell, into the record, both his statement and some letters 
that were actually sent to him.
    Mr. Bilirakis. Without objection that is the case, and, of 
course, the opening statements of all members of the 
subcommittee, I imagine probably Doctor Norwood put them into 
the record.
    Mr. Brown. Again, thank you, Mr. Chairman, Secretary 
Holsinger, I would like to start with you.
    In listening to testimony from all of you, and reading and 
listening over the last couple years about this whole issue, 
it's pretty clear that there is some significant amount of 
misuse, it's an interstate problem.
    Talk to us, if you would, about what programs are in place 
to help States communicate with each other and jointly monitor 
patients, given that each State program, including yours, each 
State program has its own unique structure.
    Mr. Holsinger. I think as Doctor Manchikanti said, that's 
one of the major difficulties that we have in Kentucky. We have 
not historically had surrounding States with programs, so that 
we were unable to actually contact back and forth. I think any 
State that has a program, providing their State legislation 
allows them to share that information with us, we could do 
that.
    In the case of Kentucky's KASPER program, I think that 
should there be surrounding programs and interest in other 
States, and having data from those, we could rapidly get 
legislative approval to share data.
    The problem right now is that not every State has a 
program, and depending on what your particular regional 
situation is, there's no one to share data with.
    Mr. Brown. Doctor Manchikanti, you obviously bring a unique 
perspective to this panel, you are a practicing physician, you 
contend with these issues just about every day. Are more 
patients being directed into intervention programs as a result 
of monitoring these programs, and if so, how is that 
accomplished while preserving HIPAA medical privacy 
protections?
    Mr. Manchikanti. All the programs do follow the HIPAA 
regulations, and under the NASPER they are not asking for 
anything more than what is available already in the KASPER or 
any other program.
    Whether it is a national program, State program, whether 
they monitor one drug, four drugs, they all have certain 
regulations, and they all are accessible to law enforcement.
    The only thing we are trying to do is, we want, the 
physicians want the same information which is available to law 
enforcement officials, so we want to prevent it rather than 
after something happens. We don't want to go to jail, but just 
provide the proper care.
    Mr. Brown. Tell us, run through a scenario, how you direct 
it, if you see a problem with a patient because of these 
monitoring programs, maybe either of you could answer this, 
Doctor Holsinger or Doctor Manchikanti, how do you actually 
direct a patient into one of these--into some kind of 
intervention program? What do you exactly do?
    Mr. Manchikanti. Well, each person has their own 
guidelines, each practice can have their guidelines, and the 
States have their own guidelines. But, in my practice, if I see 
a patient abusing controlled substances, I remind them that 
they already have a narcotic controlled substance from me, they 
can't be going to other physicians and obtaining them.
    So, we give them a warning, and if they are willing to 
follow it, and the mistake is not huge, we go ahead and give 
them the prescription. We continue to follow them every visit.
    Meanwhile, we'll also start doing random drug sampling on 
them. If somebody's tested positive for an illicit drug, then 
it all depends on what illicit drug it is. If it is cocaine, I 
will not provide any further drugs for them. If it is 
marijuana, I do provide them at that point, and if they test 
positive next time I will stop providing them. If they are on 
heavy drugs, and they can't just stop it immediately, we try to 
send them to the drug rehab program.
    Does that answer the question?
    Mr. Brown. Yes, good, thank you.
    Mr. Bilirakis. I thank the gentleman.
    Mr. Whitfield to inquire.
    Mr. Whitfield. Thank you, Mr. Chairman.
    You know, we could stay here all afternoon, and we could 
talk about confidentiality issues, we could talk about which 
department of Government would be the appropriate department to 
administer a program, we could talk about which schedule of 
drugs should be monitored, we could talk about who would have 
access to the information, all those things, but the bottom 
line is this, the first program started in 1940, we are 64 
years later, we have 16 programs, and we could work out all of 
those previous things that I talked about.
    And, I notice that, Ms. Droz, in your testimony you said 
that the group that you represent, the National Association of 
State Controlled Substance Authorities, are opposed to a 
Federal program because it would be duplicative of the States' 
efforts.
    But, when you consider that we already have a Controlled 
Substance Act, we have the DEA involved, we have the Medicaid 
program, and now we are going to have a prescription drug 
program through Medicare, and we have 64 years in which States 
have not taken action, why should the Federal Government not 
take action and at least mandate the States, or at least 
implement a Federal program?
    Ms. Droz. My organization is very supportive of 
prescription monitoring programs, and we believe there is a 
role for the Federal Government. However, our position is 
merely that one size does not fit all.
    We would support Federal legislation to mandate that States 
have programs, and set some common parameters that would allow 
States to share information, but as far as--but we believe that 
States should be allowed to make some modifications to address 
particular States' needs.
    Mr. Whitfield. And, Utah has a program that evidently was 
started on $50,000, and I don't know all the details of it, but 
it would sound like it's a pretty minimal program.
    If you had a Federal program that provided some minimum 
guidelines, and then required every State to provide 
information to it, the bill that we have, for example, even 
allows States to continue their program that's already in 
existence, or even form a program, but the data would have to 
be transferred to the Federal Government, so that that data 
would be available there. I mean, would you be opposed to that 
kind of an approach?
    Ms. Droz. Representative Whitfield, the fear of the members 
is that with that kind of approach that our State legislators 
would say, well, if the Feds are going to fund those programs 
there's no longer any need for us to continue our State 
program.
    Mr. Whitfield. Doctor Holsinger.
    Mr. Holsinger. I think it's interesting, the KASPER program 
in Kentucky began with an appropriation from the State 
legislature for $425,000 for the first year of operations. It 
went up to $500,000, and then up to $725,000 a year, which is 
what it's at now. So, for less than $1 million we operate this 
program a year. It's all on State general funds.
    We did have, at one time, $150,000 in the first 2 years 
from a Federal Department of Justice grant, to help get it 
started, but in general this has been a program that's been 
underwritten by the taxpayers of the Commonwealth of Kentucky, 
because there's a real interest on the part of, not only our 
legislature, but our Governor and the rest of us, that we work 
to control the problem.
    Mr. Whitfield. So, a real concern is that the States have 
been putting in money, primarily, and without that you would 
not have a program. But, I thought that Congressman Rogers 
indicated that over $16.5 million had been appropriated for 
grants to help start these programs, is that correct?
    Ms. Droz. Yes, that's correct. There were two separate 
appropriations to allow States to implement new programs or 
enhance current programs, and this goes a long way.
    A number of the States that have implemented new programs 
and passed their laws is because of the money that's been 
available from Congressman Rogers' grant program.
    Mr. Whitfield. Yes.
    Mr. Holsinger. And, in point of fact, in Kentucky, as we 
move forward to enhance KASPER and take it to a real-time 
operation, we intend to be applying for grant funds from those 
as well.
    Mr. Whitfield. So, at least I sense that you would not 
oppose mandates, and if the Federal Government were able to 
come forth with the money, more than likely these differences 
on approaches could probably be worked out. Would that be 
incorrect or would that be correct?
    Ms. Droz. That is absolutely correct.
    Mr. Whitfield. Thank you.
    Mr. Bilirakis. Mr. Pallone to inquire.
    Mr. Pallone. Thank you, Mr. Chairman.
    Mr. Chairman, can I just request that, this is at the 
request of Mr. Stupak, because he had to go back home, if we 
could submit written questions to the panel?
    Mr. Bilirakis. As we do customarily.
    Mr. Pallone. Thank you.
    Mr. Bilirakis. You know, we always ask witnesses to make 
themselves available for written questions. By all means.
    Mr. Pallone. Thank you.
    I just wanted to ask two questions, I guess, of Doctor 
Manchikanti, but, you know, just listening to the comments, I 
was glad--of the questions that were asked of Ms. Droz, because 
in your statement you say that you would support a mandate for 
all States to develop programs with standard features. So, I 
know that there's a difference between the bill that I support, 
which would have a Federal program, versus a State mandate. 
But, it's clear that you would support a mandate, and some kind 
of Federal guidelines, correct?
    Ms. Droz. Yes, sir.
    Mr. Pallone. Okay.
    The problem, of course, and Doctor Manchikanti, basically, 
raised it, is that--and so did Mr. Whitfield, is that, you 
know, it would be nice if we could rely on the States to do 
this, and, of course, Kentucky is the best example of a State 
that has, and even funds it, but, you know, after so many years 
we only have about 15 or 16 States that have moved in that 
direction. And, without a national program, or at minimum a 
State mandate, a Federal mandate, I think the likelihood is 
that we are not going to get that many more States to do this.
    And, both, I think, Doctor Manchikanti and Ms. Crosse, 
stressed the fact, and the GAO report stresses the fact, that 
the diversion, in other words, because of the fact that some 
States don't have monitoring you have diversion of these 
practices and illegal practices by the States.
    So, I just wanted to ask Doctor Manchikanti first, you 
indicated that a number of the surrounding States from Kentucky 
do not have a monitoring program, and I just wanted you to tell 
us a little more about how this regional patchwork impacts your 
ability to treat your patients. I know you talked about that a 
little bit, if you could develop it a little more.
    Mr. Manchikanti. Actually, there are two States, according 
to the list, who do have programs, that is Illinois and 
Indiana. This really exemplifies the differences. Indiana and 
Illinois monitor only Schedule II drugs, and there are, 
basically, law enforcement issues. But, as KASPER in Kentucky 
is public health, they are helping the patients and the 
physicians, mainly the patients.
    So, I really have problem. We have an Illinois office, and 
we are really improving the practice there. I just had to hire 
another nurse, so she can collect information on the patients 
who are presenting to Illinois office, by making all the phone 
calls to the office. So, it is just costing me one extra nurse, 
just to get the information on these patients.
    Sometimes we have to call ten, 12 doctors offices to get 
the information. But, as in Kentucky, we don't have to do that 
if the patient is from Kentucky.
    Mr. Pallone. And then a second question, but it's along the 
same lines. As we mentioned, in the last 60 years, you know, 
less than 20 States have fully implemented a prescription drug 
monitoring program, and, of course, your organization has 
doctors from all over the country, and has worked on this at 
every level. But, absent a national approach, which obviously 
you and I support, do you think that individual States will 
enact a drug monitoring program, and how the State approach 
will impact your ability to treat your patients. In other 
words, you know, on the one hand we'd like to see a national 
bill, on the other hand Ms. Droz has said, you know, we could 
have a Federal mandate linked with Federal guidelines. But, I 
mean, absent something, my impression is that we are not going 
to make much progress.
    And so, I just wanted you to say, you know, tell us without 
this national approach, what do you think is going to happen, 
and how is that, you know, continuation of this State-by-State 
approach going to impact your ability to treat your patients?
    Mr. Manchikanti. Well, with all the hoopla about 21, 20 
programs, actually, there are only 15 functioning programs, if 
you include West Virginia, that makes it 16. I really do not 
know where these other five programs are coming from, what they 
have to offer or anything.
    Out of these 16 programs, only five programs monitor 
Schedule III and IV drugs. That is where most of the abuse is 
going to be imputed, with all the crackdown on OxyContin, 
Schedule III and IV are going to be extremely important.
    In Kentucky, hydrocodone is the most abusive drug, that is 
Schedule III drug. So, that is being monitored only in 4 or 5 
States. So, the remaining 11 programs, they have to make 
radical changes, so the only programs which are functional are 
4 or 5, so short of national approach or mandated approach for 
every State, with data sharing, there is no solution. We will 
be talking the same thing after 20 years, and my children will 
be talking the same thing, and people will be much more 
serious.
    Mr. Pallone. Thank you.
    Thank you, Mr. Chairman.
    Mr. Bilirakis. So, do you all, basically, agree with Doctor 
Manchikanti, if I may follow up on Mr. Pallone, that, 
basically, without some sort of a mandate or some sort of a 
Federal type of a program that a lot of the States are just not 
going to do the job? Do you have any opinions on that?
    Ms. Crosse. We don't have an opinion, GAO doesn't have a 
position on whether or not a Federal program or a mandated 
State program, or a State initiative program is preferable.
    Clearly, there are problems right now that occur because of 
the patchwork of coverage, with some States having monitoring 
programs and other States having no program.
    As to the number of States that are coming on line, with 
the Rogers funding from the Department of Justice, there are a 
few States that are in the early stages of developing programs. 
Virginia has a pilot program in a few counties in southwestern 
Virginia. New Mexico will be able to resume it's program. It 
hopes to bring that back on line later this year.
    There is some startup funding available in some other 
States, Alabama, Florida, Maine, and Wyoming, they have bills 
under consideration in their legislatures, but it's not clear 
whether that legislation will pass and those programs will go 
into implementation. But, they've also received funding.
    Also Ohio and Pennsylvania have received some funding, 
because they've had legislation under consideration, but none 
of those programs are ready to go. So, it's not clear how 
quickly other States will be able to implement programs.
    Mr. Bilirakis. Okay.
    Well, if you have any--do you have any opinion on this, Ms. 
Droz?
    Ms. Droz. Yes, Chairman, I do.
    I believe that the statements are very accurate, that 
without a Federal mandate and Federal funding we will continue 
to see this patchwork, because there's a lot of interest in 
this program in every State, but there's not the will to put 
them in place in every State. So, absent some action by the 
Federal Government, by Congress, I think we'll continue to have 
problems.
    Mr. Bilirakis. Doctor Holsinger, I think you've already 
testified to that fact.
    Mr. Holsinger. Right, I think that certainly in the 
Commonwealth of Kentucky, we would consider it to be extremely 
helpful to know what's happening in surrounding States, and to 
be able to share data certainly within the confines of 
particular requirements.
    There's a question that hangs out there, though, that you 
all will need to wrestle with, and that's who is going to be 
the enforcer of such a program, whether it's State mandates or 
a Federal program. We certainly know--the reason I say that, I 
think we certainly know that in our Commonwealth our law 
enforcement officers are extremely interested in this program. 
It has made life tremendously better for them. They've allowed 
them to deal with these cases in a much more efficacious way, 
and a much more effective way, so I'm sure that they would want 
to be at the table in any of those kind of discussions.
    But, I think it would be fair to say that the 
administration's position in the Commonwealth of Kentucky is 
that whatever system, you as the national policymakers decide 
is the right way to go, we will work within that, and be happy 
to do so.
    Mr. Bilirakis. Doctor Manchikanti, we've already heard from 
you on that, so I think that your feeling is that there's got 
to be some sort of a mandate or something of that nature.
    Mr. Manchikanti. That is correct, workable.
    Mr. Bilirakis. Yes, workable.
    Doctor Norwood.
    Mr. Norwood. Thank you, Mr. Chairman.
    I want to work on the record here just a little bit. First 
of all, Ed and I have two separate bills, and Mr. Pallone and 
Mr. Strickland, and they really are different. Ed's bill is a 
monitoring bill, State--I mean, federally mandated, ours is a 
State monitoring bill with a Federal floor and the dollars put 
to it.
    Also, our bill goes a lot further. We are after stopping 
the misuse of Class II, III and IVs, not just simply having a 
monitoring program. Now, it's a little misleading to say, well, 
gosh, we've had 63 years and nobody has been involved.
    As Chairman Rogers pointed out, it seems to me States are 
starting to get involved the more money he puts into it. We had 
15, five more coming on line, there's a simple answer to that, 
that's because money is available.
    Kentucky has done a fabulous job. I do nothing, Doctor 
Holsinger, but give you credit. You ain't funding that program, 
you put some money into it in 2004, but you are fortunate to 
have a great Member of Congress who is on Appropriations who 
has funded the program. And, what we're saying is, that States 
ought to have at least a bottom line to which they must do, I 
believe very strongly States will fall right into this thing as 
soon as we put the dollars to it, and then it actually does 
work.
    The reason you don't have States around you that have 
monitoring programs, in my opinion, is that Congressman Rogers 
has slowly but surely added more money to it and more States 
will come in line.
    Now, let me just ask a couple of quick little questions now 
that we've got that straight.
    If we were to pass a law, you got it all, Mr. Pallone, it 
isn't exactly like nobody has been paying attention, if we were 
to pass a law today outlawing the manufacture of OxyContin, 
nobody can make it, it's against the law, you go to prison if 
you make it in the United States, what would happen, Doctor 
Holsinger, to your monitoring program? Would you get to go out 
of business then?
    Mr. Holsinger. Oh, heavens no. We monitor Class II, III and 
IV drugs, and OxyContin is only the fourth largest prescribed 
medication, we have 90 percent. We still have a problem, as you 
heard from Doctor Manchikanti, that's not our biggest problem 
today.
    Mr. Norwood. Well, that's it, I just needed to hear you say 
that, because I believe that, too. This is not something new. 
We act like this is something that just started last week. This 
has been going on a long, long time, and we're finally getting 
to, hopefully, dealing with the problem and, hopefully, Georgia 
will do it as well as Kentucky is doing it.
    Let's say your monitoring program works so great, it 
absolutely, and should, put a stop to doctor shopping. Can you 
go out of business now?
    Mr. Holsinger. No, because our physicians rely upon this 
program in Kentucky in order to be able to practice quality 
medicine as far as pain medications are concerned.
    Mr. Norwood. I agree, that's different though. That is not 
exactly the same thing as stopping the illegal use of these 
drugs.
    Mr. Holsinger. Right, but I believe that we have a program 
that plays a major role, according to our physicians, in the 
care of their patients in a quality way. For that reason alone, 
I'd continue the program.
    Mr. Norwood. I would, too, don't misunderstand me, I would, 
too.
    Mr. Holsinger. I recognize that we are on the same side.
    Mr. Norwood. But, what I'm getting at here is, that if you 
stop doctor shopping, if you absolutely bring it to an end, and 
I hope to God to put everyone of them in jail, if you do that, 
there are still other ways to get to the drugs, and we can't 
ignore that if our goal is to try to prevent the misuse of 
opiates. Would you tend to agree with that?
    Mr. Holsinger. I would.
    Mr. Norwood. It's also my impression that pharmaceutical 
companies that market directly to patients, as opposed to 
marketing to physicians, who, you know, they have a position of 
I'd like to sell my product, I put it on the back of the 
physician, the dentist, whatever, they need to make the right 
call about what's used, but it concerns me about companies that 
market directly to patients out there, that make them want some 
of these drugs.
    Now, does anybody know if the maker of OxyContin markets 
directly to patients? Because if that's going on, we need to 
revise our bill. Does anybody know the answer to that?
    Yes, ma'am.
    Ms. Crosse. We recently completed a study of OxyContin's 
marketing, and we did not find that they have a program aimed 
at direct marketing to patients. They have activities marketing 
to physicians that have included some videos that physicians 
could use to show to patients that would provide information 
about pain relief drugs.
    Mr. Norwood. Well, that's----
    Ms. Crosse. But, it's not in direct consumer type of 
advertising that you would see with advertisements on 
television or advertisements in the popular press. It is rather 
through physicians that they are providing information to 
patients.
    Mr. Norwood. Real quickly, real-time information, I think 
that's very important.
    Doctor--any of you, do you agree with that?
    Mr. Holsinger. Correct.
    Mr. Norwood. How much trouble are you having, and I'm 
having to hurry, how much trouble are you having with privacy? 
I'm very concerned about that, and hear people talking about 
that, you have a lot of people that can access your program, 
I'm just wondering what the experience is.
    Mr. Bilirakis. Let's do it, but quickly.
    Mr. Holsinger. I think we've not had a real problem with 
issues around leakage of information.
    Mr. Bilirakis. Anybody else, any comments regarding that 
question?
    Are you satisfied, Doctor Norwood?
    Mr. Norwood. For that round.
    Mr. Bilirakis. Mr. Strickland to inquire.
    Mr. Strickland. Thank you, Mr. Chairman.
    It seems to me that States may not implement this program 
for, basically, three reasons, money, awareness of the need, or 
privacy concerns.
    Quite frankly, from where I'm coming from, if a State 
decides that the privacy concerns can't be overcome then they 
can choose to opt out. But, I agree with Doctor Norwood, that 
if you provide the money, I find it unlikely that States are 
going to not move forward and implement these programs.
    I also agree that there are lots of ways that these 
medicines can be diverted and abused, the Internet, the misuse 
of the law allowing personal use of medication to be brought 
into the country.
    And, the bill that Doctor Norwood and I have been working 
on, I think will approach these things in a comprehensive 
manner. But, just let me ask you your personal opinion.
    If we were to make available $25 million for startup costs 
to States, and if we were to make available $10 million to 
carry forth this activity, do you think the States would likely 
ignore this opportunity, or do you think the States would more 
likely, in fact, choose to undertake this activity? I'm just 
asking for your personal opinion.
    Mr. Holsinger. I think that my sense would be that the 
likelihood is that States would be more likely to come on line. 
I think, though, that there are two or three States that have 
very far advanced programs, like Kentucky, and that with a 
probably reasonably minor amount of money in the greater scheme 
of things we could bring the system into real-time operation, 
and that could be, in turn, offered to other States as a way of 
being able to move forward more rapidly and with less cost.
    I think rather than inventing 50 different wheels, we ought 
to look at two or three that are really good and see which one 
we think would be the best national model, and to let that one 
be, you know, worked to fine tuning it, and then make it 
available to other States, you know, with only the cost of 
implementation. I think you could save a lot of money.
    Mr. Strickland. I have here a statement, Mr. Chairman, I'd 
like to make reference to. It's from the American Medical 
Association. They point out that they support a State-based 
rather than a federally based program for a variety of reasons. 
They point out what some States have already done, mentioning 
Kentucky, Nevada, and Utah, for example. And then, they point 
out these things.
    Whenever a drug problem--wherever a drug problem lies, the 
States are better positioned than the Federal Government to 
have incite into how best to address their own unique problems.
    Another reason that they think it ought to be State-based 
is that medicine itself has been, and should remain, regulated 
by the States physicians, pharmacists and other healthcare 
providers are all licensed by the State in which they practice.
    And so, it seems to me that the concern that we not have a 
mandate will result in States not choosing to proceed here, 
because 60 years have passed and we have not yet done it, as 
Doctor Norwood points out. I think there's a reason for that, 
awareness being one, and we are probably more aware than we 
have been, but certainly resources. If the Federal Government 
provides the money, it is my judgment that the States will, in 
fact, take advantage of that opportunity and develop these 
programs.
    So, I would return the balance of my time, Mr. Chairman. 
Thank you for the opportunity to ask questions.
    Mr. Bilirakis. I thank the gentleman.
    Mr. Buyer to inquire.
    Mr. Buyer. Thank you.
    Earlier in my opening statement, I made some comments and 
referred to dentists, and I said to my colleague, Doctor 
Norwood, I was not casting aspersions upon your profession, 
because my father is a dentist, my grandfather is a dentist, my 
brother is a dentist, my sister is a dentist, my cousin is a 
dentist, my uncle is a dentist, and you chose to follow 
halitosis and so did they. I chose not to, but I respect your 
profession, Doctor.
    Mr. Norwood. Well, I was going to tell them all what you 
said.
    Mr. Buyer. Okay, I thought I'd beat you to it.
    I will say this, though, Doctor Norwood, and to others, I 
really didn't know a lot about this issue until my sister, who 
was then the--Doctor Diane Buyer, was the Editor of the Indiana 
Dental Journal, and she wrote an article that became very 
controversial at the time, but she went into the issue about 
the profession themselves prescribing these controlled 
substances for each other, their colleagues, and abuse of 
themselves. And, actually, it turned out to be positive, 
because it got the profession talking about it and beginning to 
police themselves.
    So, I want to turn to you and ask about these monitoring 
programs, and I call it the dark side of the profession, it's 
not just dentistry, it's all the professions, and if one does 
it, then it makes them all look bad.
    So, do these monitoring programs at all address what occurs 
in the professions, in terms of the doctors we have here?
    Mr. Manchikanti. Yes. I am a member of the Kentucky Board 
of Medical Licensure. Our investigations have gone up 
substantially. So far, medical boards can be as tough as you 
want, we can stop everyone, but they won't be able to catch 
every person. Plus, there has to be a complaint filed on a 
physician. Unless there is a complaint, medical board cannot 
inquire.
    They are punishing them strictly, and there was just an 
article in Jeffersonville, one of the newspapers, how many 
doctors are losing their licenses because of controlled 
substances. Kentucky ranks fifth in the Nation for disciplining 
physicians. Sixty to 70 percent of the disciplines are related 
to the controlled substance prescription patterns. Kentucky has 
the guidelines for that purpose.
    Mr. Buyer. All right, thank you.
    Are other States doing this, including it in their 
programs? GAO?
    Ms. Crosse. Most of the States are like Kentucky, in that 
they are reactive if there is a complaint, if there is some 
other evidence that would lead to an investigation of a 
practitioner, then the data would be available through the 
program. But, very few States are using it to monitor 
individuals in a proactive way, to look for problems just 
arising out of the data.
    Mr. Buyer. I'll have further questions as this bill goes 
forward, and I look forward to working with the authors of the 
bill.
    The other point, if I could--I'll work with you on that--
the other issue I have is, in the face of an over litigious 
bar, the trial lawyers, we have this sort of trend in our 
American society whereby we don't want to accept personal 
responsibility, and if we can blame something on someone else 
that's wonderful. At the same time, we have a victim of a 
particular crime, and these trial lawyers are then looking for 
deep pockets and being very creative.
    So, my question is, have there been any lawsuits against--
have there been any lawsuits, or is there a potential of 
liability to a State monitoring program that has not done its 
job, or has been alleged negligence, brought into party to a 
lawsuit against a drug manufacturer? Has that occurred yet?
    Mr. Manchikanti. To the best of my knowledge, no.
    Mr. Buyer. GAO, did you see any evidence of this in your 
study?
    Ms. Crosse. Well, there are a number of lawsuits that have 
been filed against the manufacturer or OxyContin, alleging that 
the patient was misled about the drug, and was inappropriately 
treated with it, and are now physically dependent or addicted 
to the drug.
    Mr. Buyer. Do you see it possible that a State could be 
brought in as a party to a lawsuit if the State did not 
adequately fund a particular program and, therefore, they were 
negligent in their monitoring, and are subject to liability 
just as the manufacturer?
    Mr. Holsinger. We would claim sovereign immunity, I 
believe, in the Commonwealth of Kentucky.
    Mr. Buyer. You claim immunity.
    Mr. Holsinger. Sure. We have a very strong sovereign 
immunity in the Commonwealth of Kentucky, which has just in the 
last 5 years been reiterated by the State Supreme Court, over a 
case involving the University of Kentucky Hospital, which is a 
State-owned hospital, which has sovereign immunity as well.
    Mr. Bilirakis. I think you'll find that probably that 
exists in every State in a variety of ways.
    Mr. Greenwood to inquire.
    Mr. Greenwood. Thank you, Mr. Chairman.
    First, let me say to the GAO, thank you for the report that 
responded to the request of Congressman Wolfe, Rogers and 
myself. It's pretty well done.
    Let me, from my experience, and I got into this years ago 
when we had a doctor in Bucks County, my district, who was--his 
name was Palino, and he was--had an operation, he had actually 
lost his license, but when the DEA got down and investigated 
him he was--he was turned in by a pharmacist who saw all these 
people coming in with their prescriptions. His waiting room was 
a room fool of zombies, and his parking lot was a parking lot 
full of zombies, and they were basically going in and giving 
him $60 for what he was writing down as a routine examination, 
and just handing out scripts for OxyContin.
    As I've looked into this issue, my vision of what would 
work is something like this, and I'd like your response. My 
vision is, every pharmacist in the country, when they fill a 
prescription for one of these scheduled drugs, goes onto a web 
site and enters in the details about the doctor, and then the 
patient, and the drug, and the dosage and so forth, and that 
that information then would be downloaded to one secure--it 
would go to the State, but also it would simultaneously go in 
real time to a secure server in Washington, either HHS or DEA, 
and that the software at the recipient servers, State and 
Federal level, would do real-time printouts of--or at least 
lapsed-time printouts that would indicate individuals who were 
getting prescriptions from multiple doctors. So, we'd have that 
information. And then, you would also have doctors who were 
prescribing over some threshold, so you would see the outliers 
among the physicians, and you could eventually alter the system 
so that you would not continuously kick out the big pain 
centers and so forth, and try to get to the places, the 
anomalies would be those doctors and areas that would not be 
expected to be prescribing so heavily.
    And that then, law enforcement would have the opportunity 
to focus in on both the individuals, who are doctor shopping, 
and the doctors who are patient shopping, and over prescribing.
    Now, what I'd like to ask you is just, how do you react to 
that? Is that sort of pie in the sky, or does that make sense, 
because what it involves is real time, both State and Federal 
access to the information, receiving the information, having 
access to it, and a proactive law enforcement approach as 
opposed to information being in 50 different data sources, and 
if they get around to it there is--the DEA, for instance, 
getting around to getting information and acting on it if they 
have the personnel.
    Ms. Droz. If I might respond. That sounds perfect. However, 
in brief, there are a number of technological problems with 
doing that, and at some later time I'd be happy to discuss 
those at length.
    Mr. Holsinger. I think that, you know, we've got one of the 
three advanced systems, and yet we work on a 2-week delay as 
far as the data, and right now we are working on a 4-hour 
turnaround, going to 15 minutes, going to real time for the 
turnaround information.
    But, to be able to have all the physicians offices, and all 
of the pharmacies in the country, hard wired, if you will, and 
wired into a real-time system is huge undertaking.
    Mr. Greenwood. Well, is it using--taking advantage of the 
worldwide web, having an Internet site, a secure Internet site, 
and we are not talking about new wires and new----
    Mr. Holsinger. Well, you know, that's correct, but we in 
Kentucky do not necessarily have every physician office on line 
in the Commonwealth, and we also don't necessarily have every 
physician office with a computer.
    Mr. Greenwood. Well, I understand that, but my guess is we 
are in the 90's somewhere, and it would seem to me that 
accomplishing this with 90 percent would be quite an 
accomplishment, and you could certainly--there certainly ought 
to be ways to fill in the gaps eventually. But, I would hate 
perfect to be the enemy of could have.
    Mr. Holsinger. Ms. Droz was in Kentucky at the time a lot 
of this was being worked on, but I think one of the most 
significant issues that we had to overcome was the issue of the 
feeling of intrusiveness into this, both into the physicians's 
practice, which we overcame, but also the concern about what 
happens if the data is not secure.
    And, I think one of the biggest issues we'll have is the 
issue of secure data.
    Mr. Greenwood. My time is expired, but I would look at 
those as challenges to be overcome, rather than barriers.
    Mr. Bilirakis. I would hope that you two gentleman, will 
see each other during these many years, will be able to sit 
down and get things worked out. The important thing is that we 
do something about this subject.
    You know, I'm not admonishing you, but you are both close 
friends, but if we are going to stick in a hard-headed way to 
our particular position we are not going to get anything done, 
and then have the committee doing a mark-up.
    Mr. Norwood. We discussed that today already, Mr. Chairman, 
while you were fighting out concurrently, we talked about that 
just a little bit, and everybody tends to agree on what the 
policy, basically is, the problem is. There's no excuse for 
this committee not having a unanimous vote on a bill that would 
solve this problem.
    Mr. Bilirakis. I am not going to go a second round, but I 
would say that if anyone--I'm just going to maybe extend 2 
minutes to members here to maybe close or whatever the case 
might be.
    I'll go over to this side to Mr. Pallone, 2 minutes.
    Mr. Pallone. I'm not going to--I just have one question, 
and it's about the funding. I know that there's been statements 
made by Mr. Strickland and Mr. Norwood about, you know, how 
money was given from the Federal Government to the States that 
start their programs, but I know that we already have this 
existing fund from the Hal Rogers program, and my notes say 
that in fiscal year 2003 $10 million was awarded, while in 
fiscal year 2004 $7 million in grants were given. Are these 
grants being utilized, and part of the question also, Doctor 
Manchikanti, is, you talked about how the national program 
would be very cost effective and really wouldn't cost that 
much, so if you could just comment a little on to what extent 
the existence of money now is being used by States without a 
mandate, and to what extent, what the cost would be of a cost 
effective----
    Mr. Bilirakis. You know, and I might add, as I understand 
it, those funds haven't even been authorized. It's been a case 
of appropriation.
    Mr. Pallone. Oh, well you know those appropriators, they 
are bad.
    Mr. Bilirakis. But, the money, of course, has been 
appropriated.
    Mr. Pallone. Doctor?
    Mr. Manchikanti. Well, to my knowledge, and Doctor 
Holsinger can confirm, but the Kentucky program really started 
with Kentucky tax dollars, not from Federal funds, and you may 
confirm or deny that.
    So, other programs I'm not sure why they are not starting, 
like West Virginia, which is a major problem for Kentucky. In 
1998, that is when Doctor--Mr. Rogers program started, at the 
same time they dropped their program because of the funds, lack 
of funds. After 3 years they restarted, I don't know how 
effective their program is.
    So, I'm a little bit skeptical on that issue, and I was 
reading an article in U.S.A. Today, the other day, it said that 
States really don't have any incentive to control their 
Medicaid spending because for every $1 they spend they get $3 
Federal. My calculations show that on abuser drugs, Medicaid 
funds are spent about $9 to $10 million, so States are in one 
way benefiting, even though they are trying to control the 
problem.
    Mr. Pallone. Well, is there any indication----
    Mr. Bilirakis. The gentleman's time is up.
    Mr. Pallone. Okay, I'm sorry. Forgive my rudeness.
    Mr. Bilirakis. Mr. Whitfield, 2 minutes.
    Mr. Whitfield. Mr. Chairman, thank you. I want to thank you 
also for allowing us to have this hearing on a particularly 
important subject matter, and in the spirit of further record 
clarification I would like to state that as far as I know the 
American Medical Association has not endorsed or officially 
opposed either of these bills, is my understanding. In fact, 
the only bill that has support of an organization that I know 
of is our bill, which does have the support of the 
Interventional Pain Management Association and the American 
Association of Physicians of Indian Origin.
    However, this is such an important matter, I hope that the 
will is in the Congress to provide the funding to provide the 
mechanism to get this in place around the country, and I do 
firmly believe that you can make a strong argument for a strong 
Federal program, because the Federal Government is involved in 
the largest portion of healthcare in our country today, and 
with the prescription drug program under Medicare it's going to 
be even more so, and so I think physicians need to have access, 
we need to have it available for law enforcement, we need it 
for educational purposes, and I do believe you can make a 
strong argument.
    However, we also know, and I know this very well, and 
anybody that's served in Congress knows it, you don't get 
anything done in Congress, you don't accomplish anything 
without being willing to compromise on it, and I'm not--so I 
look forward to working with all of our cohorts in trying to 
deal with this issue, and with that, having clarified the 
record, I will stop talking.
    Mr. Bilirakis. Doctor Norwood.
    Mr. Norwood. Thank you, Mr. Chairman.
    Mr. Bilirakis. Say the same thing, will you?
    Mr. Norwood. In the spirit of comedy, and the spirit of 
working this out, I won't respond to some of that, but I think 
that it is important, it is really very important, Doctor 
Holsinger, you understand the startup cost of KASPER was 
$415,000, that your great appropriator from Kentucky sent to 
Kentucky, and that's how the program got started, and that's 
how the State programs have started.
    Doctor Lax, I love that first name, Lax, tell me this, you 
are on the State Board of Medical Examiners in Kentucky, am I 
correct?
    Mr. Manchikanti. Yes, sir.
    Mr. Norwood. Yes, and you can't really inquire unless 
someone brings a complaint to the State board.
    Mr. Manchikanti. We can start April 1. They have changed 
the State law, now we can go randomly check physicians and 
prescription patterns, or even patient interception patterns, 
and who is prescribing what. But, at the same time then we will 
have these problems with money and personnel.
    Mr. Norwood. And lawyers.
    Mr. Manchikanti. Lawyers.
    Mr. Norwood. But, mostly what I'm trying to find out is, 
can you--can a red flag come up on your monitoring system, can 
that be enough for you to inquire?
    Mr. Manchikanti. After April 1 we can.
    Mr. Norwood. Great, that is an extremely important part, in 
my opinion, of this whole monitoring system.
    I've observed, just over some years being on the State 
board and different things, many physicians who are writing 
prescriptions, who have no business in writing prescriptions 
for the reasons they are writing them for, are addicted 
themselves. There seems to be, at least in Georgia, and I've 
watched this over some years, there seems to be a correlation 
with that in our State, that healthcare providers that are 
addicted to something tend to be the ones that more frequently 
are writing bad prescriptions. Is that true in Kentucky?
    Mr. Manchikanti. Yes, probably it is true throughout the 
country. We had a witness, one physician, we had an emergency 
order to take his license away, he brought about three high-
powered attorneys, and his statement was, none of them knew the 
hell we were doing. He was the only one who knew, because he 
had two back surgeries, he hurts, he knows how patients feel.
    Mr. Norwood. Mr. Chairman, that makes this even more 
important, because it's not just the misuse of prescription 
drugs, it's the bad doctors.
    Mr. Bilirakis. That's for sure. Thank you, Doctor Norwood.
    And, to close, Mr. Brown.
    Mr. Brown. I will be well under 2 minutes, thank you, Mr. 
Chairman.
    As a supporter of the Whitfield-Pallone bill, I do believe, 
in fact, that we can figure this out and work out a solution, 
and I am very hopeful that we do, and equally hopeful that we 
find the funding for this.
    Unfortunately, you know, we've spent the surplus we had, we 
have this deficit, and, unfortunately, way too often, Mr. 
Chairman, tax cuts, all the decisions we make around here, made 
it harder to come up with funding for health issues that the 
chairman and I both support. And, I hope that even though this 
is a lot of dollars, compared to other programs, that it's 
something that we can figure out how to do and make the right 
fiscal decisions and the right healthcare decisions.
    So, I yield back my 1 minute and 18 seconds, Mr. Chairman.
    Mr. Bilirakis. All right.
    The hearing is over, but we will have these written 
questions to you. Please, respond to them in a timely fashion. 
You know, I don't like to put a particular date on them, but, 
hopefully, within 2 or 3 weeks, whatever.
    When we get these two gentlemen and their co-sponsors to be 
able to sit around the table to work out something in the 
interest of time here, I'll just say getting your responses 
will be important in that regard.
    Thank you very much, it was a good hearing. We appreciate 
it.
    [Whereupon, at 3:23 p.m., the subcommittee was adjourned.]

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