[Senate Hearing 108-806]
[From the U.S. Government Publishing Office]



                                                        S. Hrg. 108-806

 PRESCRIPTION DRUG ABUSE AND DIVERSION: THE ROLE OF PRESCRIPTION DRUG 
                          MONITORING PROGRAMS

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

                                HEARING

                                 OF THE

                    COMMITTEE ON HEALTH, EDUCATION,
                          LABOR, AND PENSIONS
                          UNITED STATES SENATE

                      ONE HUNDRED EIGHTH CONGRESS

                             SECOND SESSION

                                   ON



    EXAMINING DRUG ABUSE PREVENTION ISSUES, FOCUSING ON THE ROLE OF 
 PRESCRIPTION DRUG MONITORING PROGRAMS, AND FEDERAL PRIVACY STANDARDS 
                                FOR PMPS

                               __________

                           September 23, 2004

                               __________

 Printed for the use of the Committee on Health, Education, Labor, and 
                                Pensions



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          COMMITTEE ON HEALTH, EDUCATION, LABOR, AND PENSIONS

                  JUDD GREGG, New Hampshire, Chairman

BILL FRIST, Tennessee                EDWARD M. KENNEDY, Massachusetts
MICHAEL B. ENZI, Wyoming             CHRISTOPHER J. DODD, Connecticut
LAMAR ALEXANDER, Tennessee           TOM HARKIN, Iowa
CHRISTOPHER S. BOND, Missouri        BARBARA A. MIKULSKI, Maryland
MIKE DeWINE, Ohio                    JAMES M. JEFFORDS (I), Vermont
PAT ROBERTS, Kansas                  JEFF BINGAMAN, New Mexico
JEFF SESSIONS, Alabama               PATTY MURRAY, Washington
JOHN ENSIGN, Nevada                  JACK REED, Rhode Island
LINDSEY O. GRAHAM, South Carolina    JOHN EDWARDS, North Carolina
JOHN W. WARNER, Virginia             HILLARY RODHAM CLINTON, New York

                  Sharon R. Soderstrom, Staff Director

      J. Michael Myers, Minority Staff Director and Chief Counsel

                                  (ii)

  




                            C O N T E N T S

                               __________

                               STATEMENTS

                      Thursday, September 23, 2004

                                                                   Page
Sessions, Hon. Jeff, a U.S. Senator from the State of Alabama, 
  opening statement..............................................     1
Kennedy, Hon. Edward M., a U.S. Senator from the State of 
  Massachusetts, prepared statement..............................     3
Whitfield, Hon. Ed, a U.S. Congressman from the State of 
  Kentucky, opening statement....................................    37
    Prepared statement...........................................    39
Dodd, Hon. Christopher J., a U.S. Senator from the State of 
  Connecticut, prepared statement................................    49
Holsinger, James W., Jr., M.D., Secretary, Kentucky Cabinet for 
  Health and Family Services; Sherry Green, Executive Director, 
  National Alliance for Model State Drug Laws, Alexandria, VA; 
  Kenneth G. Varley, M.D., President and Executive Director, 
  Alabama Society of Interventional Pain Physicians, and Board 
  Member, American Society of Interventional Pain Physicians; and 
  Joy L. Pritts, Assistant Research Professor, Health Policy 
  Institute, Georgetown University...............................     5
    Prepared statements of:
        Dr. Holsinger............................................     8
        Ms. Green................................................    10
        Dr. Varley...............................................    18
        Ms. Pritts...............................................    34

                          ADDITIONAL MATERIAL

Statements, articles, publications, letters, etc.:
    David Kloth, M.D., (NASPER)..................................    51

                                 (iii)

  

 
 PRESCRIPTION DRUG ABUSE AND DIVERSION: THE ROLE OF PRESCRIPTION DRUG 
                          MONITORING PROGRAMS

                              ----------                              


                      THURSDAY, SEPTEMBER 23, 2004

                                       U.S. Senate,
       Committee on Health, Education, Labor, and Pensions,
                                                    Washington, DC.
    The committee met, pursuant to notice, at 2:08 p.m., in 
room SD-430, Dirksen Senate Office Building, Hon. Jeff 
Sessions, presiding.
    Present: Senator Sessions.

                 Opening Statement of Senator Sessions

    Senator Sessions. Good afternoon. I am Senator Jeff 
Sessions, and I appreciate your attendance at a hearing today 
that I think will be interesting and deals with a very 
significant and important subject that may not solve all the 
problems we have in the world, but it deals with a very 
significant, discrete problem that is growing in America today. 
I want to thank Senator Judd Gregg, chairman of our Health, 
Education, Labor, and Pensions Committee, for allowing and 
encouraging us to have this hearing. And we have a good panel, 
and we will be discussing an important issue.
    Over the past 10 years, the abuse and diversion of 
prescription drugs has grown from a regional crisis to a 
national epidemic. The Substance Abuse and Mental Health 
Services Administration recently released the studies of the 
2003 National Survey on Drug Use and Health. Newspapers across 
the country reported the data that suggested that while the use 
of illicit drugs, such as cocaine, remained steady or even 
declined, the figure on the nonmedical use of prescription 
medications had a different story.
    Prescription drugs now rank second only to marijuana in the 
incidence of abuse. In a 1-year period, the number of 
nonmedical users of pain relievers increased to a total of 31.2 
million American adolescents and adults who have abused these 
medications at least one time in their lifetime. The number of 
first-time abusers, those who have abused prescription drugs 
for the first time, has increased 336 percent since 1990. And 
make no mistake, prescription drug addiction is a powerful 
addiction.
    While press coverage has frequently focused on the abuse 
and diversion of OxyContin and other narcotic pain relievers, 
it is clear that this problem extends to several classes of 
commonly prescribed drugs, including tranquilizers and 
stimulants. In fact, the 2003 National Survey data reflected an 
ever sharper increase in the nonmedical use of tranquilizers.
    All in all, it is estimated that over 6 million Americans 
are current abusers of prescription drugs that fall within 
these classes. The black market in diverted prescription drugs 
is now a multibillion-dollar industry. I remember as a Federal 
prosecutor that drugs like Dilaudid were regularly sold on the 
streets of our communities for $60 to $80 a pill, and it 
results in a powerful addiction.
    These numbers, tens of millions, frequently obscure the 
human tragedy of drug abuse and dependence. Each of us has 
heard the news stories of famous persons who have developed 
prescription drug abuse problems, and for many it has hit close 
to our own homes. Frequently, these stories involved a 
legitimate first prescription that evolves into an addiction 
and familiar pattern of drug-seeking behavior that takes 
addicts from doctor to doctor to get their kicks.
    To their credit, doctors do not want to be a part of this 
cycle. In fact, physicians have been the leading advocates for 
effective programs to combat prescription drug abuse and 
diversion. I remember in around 1990 I chaired a committee in 
Alabama on law enforcement issues, and we spent a lot of time 
on this very issue. We were amazed how much abuse of 
prescription drugs there was in the city of Mobile, and a 
number of steps were taken that improved that. We even 
discussed legislation that would create a system somewhat like 
this for the State of Alabama.
    This epidemic has driven, though, additional societal 
costs. The addicted fall from the productive ranks of society 
into unemployment, disability, hospitalization, and, too 
frequently, crime and incarceration. Their families and 
communities suffer along with them. Taxpayers bear the expense 
of purchasing abused or illegally diverted drugs through public 
programs and subsequently treating the medical consequences of 
misuse and addiction. Law enforcement agencies, particularly in 
rural areas, are stretched beyond their limits as the scourge 
sweeps through depressed and disadvantaged communities 
particularly.
    The physician-patient relationship has suffered as well. 
The growing addiction problem and the black market that feeds 
it has created an atmosphere in which physicians fear that 
prescribing certain high-risk medications could lead to civil 
liability or professional discipline. As a result, the problem 
has created yet another class of victims: patients who might 
find it more difficult to obtain timely, effective treatment 
for pain and other legitimate medical needs.
    Clearly, the solution depends on early identification and 
intervention of those who may be becoming addicted to illicit 
drugs. If you can intervene early before a person has sustained 
a serious addiction, that is the best time to do it.
    The purpose of today's hearing is to attempt to develop 
some sense of the scope and nature of this problem and then to 
look beyond the tragic losses and tremendous costs to potential 
solutions. So I am particularly interested in an approach that 
has been adopted by a growing number of States and has shown 
promising results: the prescription drug monitoring program. At 
the present time, 19 States have operating prescription drug 
monitoring programs. These monitoring programs have been used 
by health care providers to better deliver appropriate, 
effective treatment of pain and other conditions that require 
the use of scheduled drugs and to identify and, if appropriate, 
refer for treatment patients whose prescription history 
suggests that they are at risk for addiction.
    I am interested also in the extent to which such systems 
could enhance the ability of law enforcement to better direct 
its resources to reduce this problem and to reduce the 
investigation times. Additionally, at a time when no discussion 
of health care should avoid the topic of cost, Federal, State, 
and private payers frequently are the ones who shoulder the 
substantial burden of purchasing diverted drugs as well as 
treating the medical sequelae of abuse. Finding a cost-
efficient tool to effectively reduce the incidence of diversion 
and abuse could be expected to provide substantial savings, 
particularly for many States' financially strapped Medicare 
programs.
    It appears the States that have instituted prescription 
drug monitoring programs have realized substantial benefits. A 
2002 GAO study of these programs concluded that prescription 
monitoring programs appear to have reduced illegal drug 
diversion. However, several important issues were raised, 
including the fact that while States with monitoring programs 
saw a reduction in drug diversion activity, their neighboring 
States without programs tended to experience a corresponding 
rise, and addicts and black marketeers shifted their efforts 
across State borders.
    I am pleased that after several years of effort and with my 
full support, my own State of Alabama is moving toward 
instituting a prescription drug monitoring program. Of course, 
Alabama's program will likely affect our neighbors in 
Mississippi and Tennessee and Georgia and Florida. Certainly 
coordination among States' programs is a matter we must 
discuss. In keeping with the broadly shared goal of improving 
health information technology capabilities throughout the 
health care system--and we need to do more of that--testimony 
will also focus on current legal and technical barriers to 
making a relevant patient medication history available to 
appropriate parties and for appropriate purposes across State 
lines.
    Despite sharing many common elements, these programs do 
differ, and any Federal effort to improve on or expand 
prescription drug monitoring must take these differences into 
account.
    We will include in the record at this point the prepared 
statement of Senator Kennedy.
    [The prepared statement of Senator Kennedy follows:]

            Prepared Statement Of Senator Edward M. Kennedy

    I commend my colleague, Senator Sessions, for holding 
today's hearing on the growing national concern over 
prescription drug abuse. Over 6 million Americans use 
prescription medications for non-medical purposes. Since 1992, 
the number of young adults who abuse prescription pain 
relievers and other potentially addictive drugs has more than 
tripled, and prescription drug abuse among youths aged 12 to 17 
has increased ten fold.
    State programs to monitor the prescribing of potentially 
addictive medications can help curb this abuse. Currently, 19 
States have monitoring programs in place, including 
Massachusetts. The information can be used to identify 
physicians and patients who encourage the non-medical use of 
prescription drugs and can also be used to reduce the diversion 
of prescription drugs for illegal purposes.
    Any such program, however, must include strong safeguards 
for medical privacy, and make certain that the database cannot 
be used to bring improper pressure on physicians to avoid 
prescribing essential medication for patients in need. The 
proper treatment of patients in pain, for example, is an 
enormous medical challenge, but this essential work will be 
more difficult if patients fear that the privacy of their 
prescription histories will not be protected, or if physicians 
begin to look over their shoulders every time they prescribe 
needed pain medication.
    Congressman Whitfield and Congressman Pallone have 
introduced legislation to establish a national electronic 
database to monitor these prescriptions, and I understand that 
Senator Sessions may introduce similar legislation in the 
Senate. We all share the goal of striking the right balance 
between the interests of patients, physicians, and law 
enforcement, and I'm confident we can work together to enact 
legislation that achieves this balance.
    The current House legislation, however, grants law 
enforcement officials access too easily to the information in 
the database. Under the House bill, if law enforcement 
officials feel the information will strengthen an 
investigation, they are granted access to it, without obtaining 
a court order, and without requiring a review of the validity 
of the requests before granting access to sensitive medical 
information.
    Massachusetts' State monitoring program includes important 
safeguards against improper use of information in the database. 
It also protects against intrusive use of the database by law 
enforcement agencies, and it includes a peer review group of 
health professionals to review data collected by the program 
for signs of abuse or diversion. If the expert group identifies 
data suggesting misuse, the Public Health Commissioner is 
notified, and the Commissioner and the review group decide 
whether to handle the situation internally or notify law 
enforcement.
    If a law enforcement authority requests data on a specific 
physician or patient, the peer review group analyzes the data 
requested. If the data suggests abuse or diversion, they 
fulfill the request. If the evidence is inadequate, the review 
group will decline to release sensitive medical information.
    The peer review group is thus a protector and gatekeeper 
for the data in the State monitoring program. Massachusetts has 
successfully implemented its monitoring system, and has taken 
steps to protect the privacy of medical records and avoid 
undermining the trust between doctor and patient.
    I commend Senator Sessions for bringing the attention of 
the committee to this important issue, and for highlighting the 
benefits of a national electronic database to monitor misuse. I 
look forward to working with our colleagues on the committee to 
see that the legislation protects patient privacy and prevents 
data from being abused.
    I commend our witnesses for their testimony today, and I 
look forward to their recommendations.
    Senator Sessions. We have a very distinguished group of 
witnesses before the committee today. I think Congressman 
Whitfield is not with us at this point, not yet, and we expect 
him to join us in a little bit. But we will start with our 
larger panel first.
    I also see my former colleague, Tim Hutchinson. Tim, thank 
you for your leadership on this issue and bringing to my 
attention the importance of this issue.
    This very distinguished group of witnesses before the 
committee today should be able to shed some important light on 
these matters. I look forward to the opportunity that this will 
provide Members of Congress to develop a better understanding 
of this problem and to carefully consider how to provide the 
most useful and appropriate Federal response.
    Our first panel will consist of four additional witnesses: 
Dr. James Holsinger, the Secretary of the Kentucky Cabinet for 
Health and Family Services--Jim, you can step on up, and I 
believe your name tag is there--the agency in Kentucky that 
administers the prescription drug monitoring program. Dr. 
Holsinger can provide important details on the operation and 
impact of the KASPER program. He also is a writer and author, 
having written an exceptionally fine book on the Methodist 
Church that is read throughout the denomination, and I can say 
with certainty it has been a positive influence for the 
denomination.
    Dr. Kenneth Varley is the president of the Alabama Society 
of Interventional Pain Physicians and is a practicing pain 
specialist in Birmingham, Alabama.
    Sherry Green is the executive director of the National 
Alliance on Model State Drug Laws, an organization that has 
provided important legal and technical guidance for States that 
have elected to implement monitoring programs and other drug 
laws that you help them with.
    Finally, Joy Pritts is currently an assistant research 
professor at Georgetown University's Health Policy Institute 
and an expert who has published extensively and testified 
before Congress on medical privacy matters. Thank you, Ms. 
Pritts. We are going to hear from you on the privacy question.
    So I look forward to hearing from you, and, Dr. Holsinger, 
if you would begin, we would be glad to hear your testimony. 
And our time limit will be about 5 minutes. The light will turn 
red up here, I believe, and you do not sink into the ocean if 
you go beyond, but, Dr. Holsinger, we are delighted to have you 
with us.

   STATEMENTS OF HOLSINGER, JAMES W., JR., M.D., SECRETARY, 
KENTUCKY CABINET FOR HEALTH AND FAMILY SERVICES; SHERRY GREEN, 
  EXECUTIVE DIRECTOR, NATIONAL ALLIANCE FOR MODEL STATE DRUG 
 LAWS, ALEXANDRIA, VA; KENNETH G. VARLEY, M.D., PRESIDENT AND 
  EXECUTIVE DIRECTOR, ALABAMA SOCIETY OF INTERVENTIONAL PAIN 
       PHYSICIANS, AND BOARD MEMBER, AMERICAN SOCIETY OF 
 INTERVENTIONAL PAIN PHYSICIANS; AND JOY L. PRITTS, ASSISTANT 
    RESEARCH PROFESSOR, HEALTH POLICY INSTITUTE, GEORGETOWN 
                           UNIVERSITY

    Dr. Holsinger. Senator Sessions, it is a real pleasure to 
be here with you today. I am here to discuss briefly Kentucky's 
implementation of a prescription drug monitoring program, the 
status of the current system enhancements, and the goals of the 
Commonwealth of Kentucky in detecting and preventing 
prescription drug abuse and diversion.
    Before I begin, I would certainly like to thank and 
recognize Congressman Ed Whitfield who is passionate about 
wanting us to work toward reducing the abuse of prescription 
drugs in the Commonwealth and beyond, and also Congressman Hal 
Rogers, the Dean of Kentucky's congressional delegation, for 
all of his hard work to reduce the abuse of prescription drugs.
    Senator Sessions. Dr. Holsinger, I would say that I 
understand the House is in a series of votes. Congressman 
Whitfield came by and talked to me yesterday. I am sure he will 
be here when he can break free.
    Dr. Holsinger. There is no question that prescription drug 
abuse and diversion is a public health crisis of significant 
magnitude. Accordingly, failing to combat this issue with great 
vigor on multiple fronts and in a highly coordinated fashion 
will undoubtedly lead to dire health and safety consequences 
nationwide.
    Prescription drug monitoring programs are designed to help 
prevent and detect the diversion and abuse of pharmaceutical 
controlled substances, particularly at the retail level. States 
that have implemented prescription monitoring programs have the 
capability to collect and analyze prescription data much more 
efficiently than States without such programs, where the 
collection of prescription information requires the manual 
review of pharmacy files, a time-consuming and invasive 
process.
    The purpose of PMPs is to enhance the ability of health 
care professionals, as well as regulatory and law enforcement 
agencies, to collect and analyze controlled substance 
prescription data. This is accomplished by building a data 
collection and analysis system at the State level, enhancing 
programs' ability to analyze and use collected data, and 
facilitating the exchange of collected prescription data among 
States. The increased efficiency of prescription monitoring 
programs allows for the early detection of abuse trends and 
possible sources of diversion. In your packet is a chart that 
depicts the KASPER process, as well as some rather impressive 
statistical information generated from the program.
    I think one of the most impressive things that we deal with 
is the fact that of the individuals and organizations that 
enter the system, 85 percent of those are physicians, 
indicating a high degree of acceptance on their part.
    Kentucky's prescription drug monitoring program was 
established during the Kentucky General Assembly's 1998 
legislative session, and the program become operational in 
1999.
    It is commonly referred to as ``KASPER,'' which is the 
acronym for the Kentucky All Schedule Prescription Electronic 
Reporting system. 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 created with two main goals in mind: first, to 
be a source of information for physicians and pharmacists; and, 
second, to be an investigative tool for law enforcement. KASPER 
is the instrument that enables this information to be 
collected, analyzed, and shared rapidly.
    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 to be loaded into the KASPER 
server.
    Very high security procedures protect access to the data 
with only branch personnel having access to information within 
the KASPER database. Reports requested by authorized 
individuals also undergo a high level of scrutiny. Release of 
data to anyone not authorized by Kentucky's statute is a Class 
D felony.
    Currently, there are approximately 30 States with some form 
of a PMP in operation although only Kentucky, Michigan, and 
Nevada have electronic systems requiring the collection of data 
on all scheduled drugs. In Kentucky, the KASPER program is 
administered by the Cabinet for Health and Family Services' 
Office of Inspector General. Controlled substance prescription 
reports, KASPER reports, are available to physicians, in the 
treatment of patients; pharmacists, in the treatment of 
patients; law enforcement, in conjunction with a bona fide 
investigation; professional licensure boards, in investigation 
of their members; Medicaid departments, for prevention of fraud 
and abuse; and by grand jury subpoena and court orders.
    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. Indeed, as a result of KASPER, 
reporting of KASPER productivity in a variety of instances, 
including that of law enforcement, has increased 30-fold and 
investigative productivity has improved 5-fold.
    In 2003, the Kentucky Legislature appropriated $1.4 million 
to enhance the current KASPER system. The goals of the Enhanced 
KASPER, eKASPER system, are to automate the labor-intensive 
processes of report creation, reduce report distribution from a 
4-hour goal to 15 minutes, and assure HIPAA compliance at all 
levels.
    In 2004, the Kentucky General Assembly passed legislation 
that empowers the Cabinet to develop structures and processes 
with the KASPER system to study utilization trends, make 
referrals to law enforcement and regulatory bodies, and utilize 
KASPER reports in administrative hearings. It is our absolute 
intention to continue to refine and enhance our efforts in 
detecting and preventing prescription drug abuse and diversion 
in the Commonwealth. As I have discussed today, KASPER is a 
vital tool that plays a critical role in our efforts. KASPER is 
as useful for the physician as it is for the investigator. Of 
course, as it is the surgeon, not the scalpel, that saves the 
patient, ultimately these issues will only be solved by 
employing the skill and knowledge of individuals from a variety 
of fields. It is our belief that only a balanced and systemic 
approach that includes prevention, education, treatment, and 
enforcement will have a significant and sustainable positive 
impact on what has become a very serious and insidious matter 
of public health and safety.
    I appreciate your time and your interest in what I believe 
is a critical matter for the Commonwealth of Kentucky, as well 
as nationwide. Part of what we have been involved with recently 
has been a broad-scale, statewide drug control assessment 
summit that occurred this year under the auspices of our new 
Governor, Governor Ernie Fletcher, and our Lieutenant Governor, 
Steve Pence. Out of these, we are again working to develop 
statewide approaches to deal with a significant issue that 
particularly has great ramifications, I believe, for us from 
the point of view of not only public health but public policy.
    I will be happy to answer any questions when the times 
comes, Senator. Thank you very much.
    Senator Sessions. Thank you very much, Dr. Holsinger.
    [The prepared statement of Dr. Holsinger follows:]

          Prepared Statement Of James W. Holsinger, Jr., M.D.

    Chairman Judd Gregg, and esteemed Members of the Senate Committee, 
I am here today to briefly discuss Kentucky's implementation of a 
Prescription Drug Monitoring Program (PMP), the status of the current 
system enhancements, and the goals of the Commonwealth in detecting and 
preventing prescription drug abuse and diversion.
    Before I begin, I would like to thank and recognize Congressman Ed 
Whitfield who is passionate about wanting to work towards reducing the 
abuse of prescription drugs in the Commonwealth and beyond, and 
Congressman Hal Rogers, the Dean of Kentucky's Congressional 
delegation, for all of his hard work to reduce the abuse of 
prescription drugs.
    There is no question, that prescription drug abuse and diversion is 
a public health crisis of great magnitude. Accordingly, failing to 
combat this issue with great vigor on multiple fronts, and in a highly 
coordinated fashion will undoubtedly lead to dire health and safety 
consequences nationwide.
    Prescription Drug Monitoring Programs are designed to help prevent 
and detect the diversion and abuse of pharmaceutical controlled 
substances, particularly at the retail level. States that have 
implemented prescription monitoring programs have the capability to 
collect and analyze prescription data much more efficiently than States 
without such programs, where the collection of prescription information 
requires the manual review of pharmacy files, a time-consuming and 
invasive process.
    The purpose of PMPs is to enhance the ability of health care 
professionals, as well as regulatory and law enforcement agencies, to 
collect and analyze controlled substance prescription data. This is 
accomplished by building a data collection and analysis system at the 
State level, enhancing existing programs' ability to analyze and use 
collected data, and facilitating the exchange of collected prescription 
data among States. The increased efficiency of prescription monitoring 
programs allows for the early detection of abuse trends and possible 
sources of diversion.
    In your packet is a chart depicting the KASPER process, as well as 
some rather impressive statistical information generated from the 
program.
    Kentucky's prescription drug monitoring program was established 
during the Kentucky General Assembly's 1998 Legislative Session, the 
provisions codified under KRS 218A.202. The program did not become 
operational until 1999.
    The program is commonly referred to as KASPER which 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 created with two main goals in mind. First, to be a 
source of information for physicians and pharmacists; and second, to be 
an investigative tool for law enforcement. KASPER is the instrument 
that enables this information to be collected, analyzed, and shared 
rapidly.
    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, to be 
loaded into the 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.
    Currently, there are approximately thirty (30) States with some 
form of a PMP in operation although only Kentucky, Michigan and Nevada 
have electronic systems requiring the collection of data on all 
scheduled drugs. In Kentucky, the KASPER program is administered by the 
Cabinet for Health and Family Services' Office of Inspector General, 
Division of Fraud, Waste and Abuse/Identification and Prevention, Drug 
Enforcement and Professional Practices Branch. Controlled substance 
prescription reports (KASPER Reports) are available to Physicians--in 
the treatment of patients; Pharmacists--in the treatment of patients; 
Law Enforcement--in conjunction with a bona-fide investigation; 
Professional Licensure Boards--in investigation of their members; 
Medicaid Departments--for prevention of fraud and abuse; and by Grand 
Jury Subpoenas and Court Orders.
    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. Indeed, as a result of KASPER, 
reporting productivity has increased 30 fold and investigative 
productivity has improved 5 fold.
    In 2003, the Kentucky State Legislature appropriated $1.4M to 
enhance the current KASPER system. The goals of the Enhanced KASPER 
(eKASPER) system are to automate the labor-intensive processes of 
report creation, reduce report distribution from a 4-hour goal to 15 
minutes, and assure HIPAA compliance at all levels.
    In 2004, the Kentucky General Assembly passed legislation that 
empowers the Cabinet to develop structures and processes with the 
KASPER system to study utilization trends, make referrals to law 
enforcement and regulatory bodies, and utilize KASPER reports in 
administrative hearings. It is our absolute intention to continue to 
refine and enhance our efforts in detecting and preventing prescription 
drug abuse and diversion in the Commonwealth. As I have discussed 
today, KASPER is a vital tool that plays a critical role in our 
efforts. KASPER is as useful for the physician as it is for the 
investigator. Of course, as it is the surgeon, not the scalpel that 
saves the patient, ultimately these issues will only be solved by 
employing the skill and knowledge of individuals from a variety of 
fields. It is our belief that only a balanced and systemic approach 
that includes prevention, education, treatment, and enforcement will 
have a significant and sustainable positive impact on what has become a 
very serious and insidious matter of public health and safety.
    Thank you for your time and interest in what I believe to be a very 
critical matter for the Commonwealth of Kentucky, as well as 
nationwide. I will be happy to answer any questions you may have.

    Senator Sessions. Ms. Green?
    Ms. Green. Thank you, Senator Sessions. I want to thank you 
and Members of the Committee for holding this hearing and 
allowing me to testify.
    Since 1939, States have used prescription drug monitoring 
programs, or PMPs, as they are often called, to address 
prescription drug diversion and addiction. In addition to the 
19 States currently operating in that they can respond to 
requests for information, 24 States are actively pursuing the 
establishment of a PMP; 15 of those States have Federal funds 
to do so.
    Information collected through the system is already 
available to State regulatory and enforcement personnel under 
State law. Without the PMP, they collect information manually, 
going from pharmacy to pharmacy in order to gather all the 
necessary information for an investigation.
    States often uses these particular prescription monitoring 
programs, or PMPs, as early identification mechanisms. They use 
them to spot as early as possible a potential problem of 
diversion or addiction and then to timely refer information to 
the appropriate medical professionals or State officials who 
can most appropriately address that particular problem.
    Information is most often used to corroborate an existing 
investigation, to assist with the legitimate prescribing of 
controlled substances, to intervene as early as possible with 
patients who might be addicted, to actually confirm whether or 
not a particular claim against a prescriber/dispenser has a 
legitimate basis, and also as an indicator to initiate the 
manual investigation of a particular crime or doctor-shopping 
instance.
    The States are actually actively seeking these particular 
programs primarily because right now those States with programs 
are seeing significant decreases in investigation of time. I 
know Kentucky, in addition to Nevada and Utah, are already 
indicating that they have as much as 80-percent decrease in 
investigation time needed to address the particular 
prescription diversion and addiction problem. They are also 
looking at possible instances of decrease in fraud, both in 
insurance and Medicare and other health care systems, and they 
are also starting to look at increased instances of referral to 
addiction treatment systems.
    As it stands right now, there is a national evaluation 
design that is being drafted and will be finalized by the end 
of the year, with the idea of hopefully over the next year 
being able to scientifically document effectiveness of the 
programs, particularly improvements in the programs that might 
be needed, and also cost/benefits from the particular programs 
that are currently in use.
    As it stands right now, one of the primary areas of focus 
for States with these programs and who are developing these 
programs is the particular impact of interstate issues, doctor-
shopping in particular, in several States that are looking at 
developing the programs. That kind of interstate issue is 
impacting the dispensing and prescribing to these substances, 
and States are now trying to focus on how the particular 
prescription monitoring programs can be designed to address 
those interstate issues.
    Senator, I want to thank you again for this opportunity to 
testify, and at the appropriate time I also am more than happy 
to answer any questions.
    Senator Sessions. Thank you. Well said.
    [The prepared statement of Ms. Green follows:]

                   Prepared Statement Of Sherry Green

    Chairman Gregg, Senator Sessions, Members of the Committee, and 
staff, thank you for this opportunity to appear before you today to 
offer an overview of State prescription drug monitoring programs 
(PMPs). I am honored to be here to discuss this issue at a time when 
Federal support for these programs and States' efforts to establish and 
enhance them has never been stronger.

Definition and Intent of Prescription Drug Monitoring Programs (PMP)

    For those unfamiliar with prescription monitoring programs, I offer 
the following definition. A prescription monitoring program (PMP) is a 
system into which prescription data for designated schedules of 
controlled substances are reported dispensers to a central location 
(e.g., a State agency) where the information is entered into an 
electronic database. A PMP can perform three primary functions: (1) 
data collection, (2) respond to requests for reports by those 
authorized by statute/regulation/rule to make such requests, and (3) 
optimally, data would be analyzed to spot trends and identify diversion 
and addiction issues early with reports going proactively to those who 
could respond (e.g., physicians, pharmacists, occupational licensing, 
certification and regulatory personnel, law enforcement).
    State PMPs can optimally accomplish a variety of goals related to 
safeguarding public health and safety. These purposes could include: to 
support the legitimate medical use of controlled substances; to 
facilitate and encourage the identification, intervention with and 
treatment of individuals addicted to prescription drugs; to identify 
and prevent drug diversion; to provide assistance to those 
investigating cases of diversion or other misuse; and to inform the 
public, including health care professionals and policy makers, of use 
and abuse trends related to prescription drugs (for more information 
regarding the possible missions of State prescription monitoring 
programs, please see Prescription Monitoring Work Group of the National 
Alliance for Model State Drug Laws: Recommendations for State 
Prescription Monitoring Programs, submitted with this testimony).
    The data collected in the monitoring system is not ``new'' 
information--in other words, information that was previously 
unavailable to those investigating diversion cases. With or without a 
PMP in place, prescription information is accessible to regulatory and/
or law enforcement personnel with open cases involving suspected 
diversion of prescription drugs. What the PMP does by serving as a 
central point of collecting this data and responding to authorized 
requests is to save the already limited resources of State regulatory 
boards and law enforcement by eliminating the need for their staff to 
go to individual pharmacies throughout the State in order to view the 
specific prescription data needed for diversion investigations.

NAMSDL's History Assisting States re: PMPs

    As a Congressionally-funded 501(c)(3) nonprofit organization, the 
National Alliance for Model State Drug Laws (NAMSDL) has worked with 
States to address alcohol and other drug problems through laws, 
policies, and programs, using the model laws created by NAMSDL's 
predecessor--the President's Commission on Model State Drug Laws--as a 
menu of options. Prescription drug misuse, abuse, diversion, and 
addiction have been among the issues on which States have sought 
NAMSDL's assistance since our inception in 1993, including information 
and guidance in planning, establishing, and enhancing State PMPs. 
NAMSDL's Congressional funding through the Transportation, Treasury, 
and General government (formerly Treasury, Postal, and General 
government) appropriations has permitted us to work with States on 
these issues, as well as over 70 other alcohol and other drug-related 
problems. Through a grant from the Bureau Justice Assistance (BJA), 
Office of Justice Programs, awarded in fiscal year 2003 (supplemented 
in fiscal year 2004), NAMSDL has been able to intensify efforts to 
assist States' efforts to establish PMPs and to provide opportunities 
and instruments for planning for the interstate sharing of PMP data. 
Additionally, NAMSDL is now able to make outreach to States which have 
not historically pursued the possibility of a PMP as a tool for 
addressing the misuse of, abuse of, diversion of, and addiction to 
prescription drugs and for safeguarding the availability of these 
controlled substances to individuals with bona fide medical needs.

PMPs in the States

States Currently Operating Programs
    As I testify before you today, 19 States are currently operating 
PMPs (i.e., these States have a monitoring system in place that is both 
collecting reports of the designated prescription data and responding 
to requests for information from those authorized to do so). These 
States are: California, Hawaii, Idaho, Illinois, Indiana, Kentucky, 
Maine, Massachusetts, Michigan, Nevada, New York, Oklahoma, 
Pennsylvania, Rhode Island, Texas, Utah, Virginia, Washington, and West 
Virginia.
    A variety of State agencies house and operate these programs in the 
States, based on the resources, capabilities, purview, and other State-
specific considerations as to where the PMP would be best suited in 
each State (for more discussion of factors States consider in 
determining which agency should house and operate a PMP, please see the 
report of NAMSDL's national working group on State PMPs, submitted with 
this testimony). Of the 19 State PMPs currently in place, nine are 
housed and operated by State agencies responsible for public health, 
five by law enforcement/public safety departments, four by Boards of 
Pharmacy, and one--Maine--by the single State authority for substance 
abuse (a listing of the 19 current State PMPs and their overseeing 
agencies is provided with this testimony).

Projected Growth of State PMPs
    In an effort to better address prescription drug misuse, abuse, 
diversion, and addiction, a significant number of States are mobilizing 
to establish PMPs. Wyoming and New Mexico are currently on track to 
being operating State PMPs by the end of calendar year 2004. With 
legislation in place, Alabama and Tennessee could be operating PMPs by 
early 2005. Iowa and Mississippi have determined that they can, per 
their Controlled Substances Act, establish PMPs through rule changes by 
their Boards of Pharmacy; these changes are currently being pursued to 
ready these States to being operating monitoring systems. Additionally, 
the following 18 States are actively pursuing legislation/regulations/
rules and/or planning the structure necessary to begin these programs: 
Colorado, Connecticut, Florida, Georgia, Kansas, Louisiana, New Jersey, 
Ohio, Oregon, Missouri, Montana, New Hampshire, North Carolina, North 
Dakota, South Carolina, South Dakota, Vermont, and Wisconsin. NAMSDL 
continues to reach out with information and offers of technical 
assistance to the States that have not taken steps toward establishing 
PMPs or that are in the very nascent stages of planning.

Funding for State PMPs
    Prior to fiscal year 2002, there were 15 States operating PMPs. 
States funded these programs as part of State agency budgets, fees from 
regulatory and/or licensing boards, private funding, or some 
combination of these funding streams. In fiscal year 2002, the Harold 
Rogers Prescription Drug Monitoring Program, a competitive grant 
program administered since fiscal year 2002 by the Bureau of Justice 
Assistance, Office of Justice Programs, was established to support 
State efforts to plan for, establish, and enhance PMPs. Since its 
inception, this funding opportunity has resulted in 14 States receiving 
new program grants and 6 States netting planning grants (a listing of 
States receiving these grants is provided with this testimony). To 
date, eight States have asked NAMSDL staff about the possibility and 
timing of fiscal year 2005 Federal funding to assist in moving their 
efforts to establish programs forward. As we continue our outreach to 
States to engage them in planning efforts, this interest in Federal 
assistance is likely to rise.
    Understanding that current Federal assistance is not intended to be 
used as operating or sustaining funding, States with planning and new 
program grants as well as those intending to apply for any fiscal year 
2005 opportunities continue to develop options for funding the 
operations of State PMPs overtime. Private funding, pharmacy licensing 
fees, State appropriations, and State controlled substances 
registration fees are alternatives being considered by States for the 
continuing operation of new programs. Individuals working closely with 
existing PMPs and efforts to establish new monitoring systems are 
confident that evaluation of these programs will show cost benefits 
such as reducing Medicaid and healthcare fraud, diversion investigation 
time, and consequences related to untreated addiction to prescription 
drugs; these savings could result in an offset of funds being available 
to operate State PMPs and the continuation of these anticipated 
savings.

Components of a Strong Prescription Monitoring Program

    I want to share NAMSDL's observations of what appear to be key 
components of PMPs and their related enabling legislation and/or 
regulations/rules. While further formal evaluation of existing State 
PMPs across the Nation is needed, I hope that our anecdotal findings 
will be helpful in understanding the types of considerations that 
States may undertake in setting up these programs.

Schedules of Drugs Monitored
    Drugs monitored optimally would include Federal controlled 
substances, additional specified controlled substances regulated by the 
State, and drugs of concern documented to demonstrate a potential for 
abuse, particularly those identified by law enforcement and addiction 
treatment professionals. While not officially scheduled, some 
substances can still be highly abused and require immediate attention. 
In a State which requires a legislative action to schedule substances, 
the prescription drug monitoring official will need the authority 
through the monitoring system to immediately address the problem. If 
the monitoring program only tracks controlled substances, the officials 
will have to wait perhaps 6 months or more for the legislature to pass 
a bill placing the abused substance on a controlled substances 
schedule.

Proactive Provision of Information
    The monitoring system should proactively provide information to law 
enforcement, occupational licensing and other appropriate individuals. 
The prescription drug monitoring official should review the information 
in the system and if there is reasonable cause to believe there has 
been a violation of law or a breach of occupational standards, the 
official should notify the appropriate agency.
    Additionally, the statute should allow the program to provide 
information for public research, policy and education purposes to the 
extent all information reasonably likely to reveal the patient or other 
person who is the subject of the information has been removed.
Individuals Allowed to Request Information from State PMPs
    Dispensers and prescribers, law enforcement officials and 
occupational licensing officials should be included among the 
individuals or officials allowed to request specific information from 
the program.

Training for Individuals Utilizing State PMPs
    Requestors of program information must demonstrate that they have 
the training necessary to responsibly and properly use the information 
they receive from the program. All requestors should be required to 
prove that they have received training on the purpose and operation of 
the program, and how to properly use the program. Additionally, health 
professionals should be required to receive training on proper 
prescribing practices, pharmacology and identification, treatment and 
referral of patients addicted to or abusing substances monitored by the 
program. This training can help physicians better assess whether the 
marketing and sales information they are given about a prescription 
drug's effects appears to be accurate.

Evaluation of State PMPs
    An evaluation component is necessary to identify cost benefits of 
the program and any recommended improvements. As part of the ongoing 
assessment process, an advisory board or council should provide advice 
and input regarding the development and operation of the prescription 
drug monitoring system. The board or council should address issues such 
as (1) what drugs of concern to be monitored, (2) what specific State 
controlled substances to be monitored, (3) what constitutes diversion 
and proper prescribing, (4) the content and implementation of 
educational courses, (5) the interpretation of prescription monitoring 
information.

Confidentiality Provisions for PMP Data
    Confidentiality protections from improper use of the system or of 
information from the system are important statutory provisions. 
Prescription monitoring information should not be subject to public or 
open records laws. Additionally, the law creating the prescription drug 
monitoring program should include penalties for knowingly disclosing or 
using information other than as authorized by the law.

Addressing Interstate Issues
    Interstate misuse and abuse of prescription drugs is an issue each 
State with a prescription drug monitoring program should attempt to 
address. By statute, regulation or interstate agreement, the State 
should speak to the following circumstances:
     pharmacies or other dispensers located in the State with a 
prescription drug monitoring program which dispense or deliver to an 
address of an ultimate user in another State;
     pharmacies or other dispensers located in another State 
which dispense or deliver to an address of an ultimate user in the 
State with a prescription drug monitoring program;
     pharmacies or other dispensers located in another State 
which dispense or deliver to an ultimate user with an official address 
in the State with a prescription drug monitoring program.

Progress on Interstate Issues

    An acknowledged challenge for States is addressing the diversion 
that can occur from State to State. In enhancing existing PMPs and in 
establishing new programs, States are working to include provisions for 
information sharing among States with monitoring systems in order to 
reduce interstate diversion. Here are several examples of current 
efforts:

Provisions for Mail Order Pharmacies
    In a survey conducted by NAMSDL of existing State PMPs, 12 of the 
19 existing PMPs indicated that they require out-of-State mail order 
pharmacies delivering or dispensing drugs into their States to report 
data to their States' PMPs (HI, ID, IL, IN, KY, ME, MI, NY, OK, RI, UT, 
WV). The reporting requirement is based on the license or registration 
which the mail order pharmacies must obtain to conduct business or 
dispense in their States. These measures can help reduce the incidents 
of ``doctor shopping'' across State lines in an effort to avoid 
detection by the monitoring system. A summary of NAMSDL's survey re: 
how State PMPs are addressing mail order pharmacies is submitted with 
this testimony.

Western States Network
    Initiated by Nevada, the Western States Network is a plan to share 
PMP data among the States with PMPs in the Western U.S. (currently 
Nevada, Idaho, California, Oklahoma, and Texas) and Hawaii through a 
secure e-mail exchange. Nevada is currently ``beta'' testing the online 
technology required before working with the other States in the region 
to establish legal agreements and then technology structures to begin 
the proposed data exchange.

Common Data Elements To Be Collected by State PMPs
    To facilitate interstate sharing of PMP data, common data elements 
must be collected by each State with a monitoring system. This will 
allow for consistency in reporting as well as, from a technological 
standpoint, a cleaner transfer of data. The National Association of 
State Controlled Substances Authorities (NASCSA) and the Alliance of 
States with Prescription Monitoring Programs, based in part on a 2003 
NASCSA survey of data that was being collected by State PMPs, convened 
a Prescription Monitoring Standards Working Group that recommended that 
States with and developing prescription monitoring systems include the 
following set of data elements:
     Dispenser identification number
     Date prescription filled
     Prescription number
     Whether the prescription is new or a refill
     NDC code for Controlled Substance dispensed
     Quantity of Controlled Substance dispensed
     Number of days' supply of Controlled Substance
     Patient identification number
     Patient last name
     Patient first name
     Patient street address
     Patient city
     Patient State
     Patient postal code
     Patient date of birth
     Prescription identification number
     Date of prescription issued by practitioner
     Person who receives the prescription from the dispenser, 
if other than the patient
     Source of payment for prescription
     State issued serial number, if applicable.
    NAMSDL has widely distributed these recommendations to States 
working to establish monitoring systems in an effort to encourage 
consistency among programs that will better facilitate interstate 
sharing. Additionally, NAMSDL includes members from NASCSA and Alliance 
of States members in our regional planning, topical working groups, and 
national meetings to keep all involved informed re: efforts in this 
area.

Legal Agreements Among States
    In addition to establish accommodating technology structures among 
States, legal agreements must be in place to allow the exchange of PMP 
data across State lines and among the entities housing the PMP and the 
entities requesting the information. Legal counsel working with NAMSDL 
on these issues suggests that these arrangements may resemble 
interstate commerce compacts that States currently utilize. NAMSDL has 
convened a national working group comprised of State administrators of 
PMPs, representatives from State attorneys general's offices, public 
health officials, addiction treatment professionals, law enforcement 
officials, and physicians (including a pain management specialist) to 
offer their expertise and recommendations toward our drafting a model 
interstate compact. This model will offer a guide for States to use in 
establishing these legal agreements for sharing PMP data.

Internet Pharmacies
    To date, three States (Arkansas, Nevada, and Florida) have State 
statutes in place addressing Internet pharmacies. Only one of these 
States--Nevada--currently has a PMP; NV's Internet pharmacy law 
requires Internet pharmacies to report to the State's PMP for 
controlled substances delivered into the State.
    Most State PMP administrators agree that as important as it is to 
have legitimate Internet pharmacies report into State PMPs, the legal 
sites are not the primary issue. Illegal Internet sites that acquire 
and deliver controlled substances to individuals without prescriptions 
for these prescription drugs are of greater concern. Federal assistance 
on this issue, such as that proposed by Senator Gregg, will be 
appreciated by States to alleviate the misuse, abuse, diversion, and 
addiction to which these illegal sites contribute.

Technical Assistance Provided to States by NAMSDL re: PMPs

    NAMSDL provides a variety of technical assistance to States as they 
plan for, establish, operate, and enhance prescription monitoring 
programs. In broad terms, the overarching goals of our services to 
States are (1) to engage States in efforts to establish PMPs, (2) to 
provide information, tools (e.g., model law, samples of grant 
applications, etc.), and referrals to minimize the State resources 
needed to begin efforts to implement monitoring systems, and (3) to 
maximize the Federal and State resources going toward State efforts by 
coordinating information and State-to-State assistance to eliminate 
inadvertent ``reinvention of the wheel'' as States implement, operate, 
or enhance these programs. Specific services include:
     Assistance in drafting enabling legislation.
     Facilitating regional planning session to further 
interstate planning.
     Providing information on current PMPs efforts to States 
planning to establish programs.
     Contacting States which have not yet mobilized to create 
PMPs and providing them start-up information.
     Bill status updates on States' legislative efforts.
     Serving as a central point for articles, materials, and 
updates re: State PMPs.
     Bimonthly updates re: State efforts, materials available, 
related Congressional news, and other relevant information.
     Connecting key constituencies groups within and among the 
States to work on establishing PMPs.
     Holding an annual conference on PMPs.
     Convening topical working groups to develop model acts, 
reports, or other resources as needed by States to address issues 
related to PMPs.
    While our current grant from BJA has allowed us to intensify our 
technical assistance to States, NAMSDL has worked with States re: PMPs 
and the related issues since our inception. If prescription drug 
diversion, misuse, abuse, and addiction continue to be priority areas 
for States, NAMSDL--as it has historically--will continue to include 
these issues in our work with States beyond the life of any grant or 
grant program.

Opportunities for Congressional, Federal Support

    I want to conclude by briefly outlining some possible opportunities 
for Congress and/or the Federal Government to support States in their 
efforts to create, sustain, and enhance prescription monitoring 
programs. These suggestions come from feedback that NAMSDL has received 
from our State colleagues as we work with them on these programs.

Funding
    Given the record budget deficits in many States at this time, it is 
unlikely that States will be able to establish new monitoring systems 
without the assistance of outside funding. Over the past few years, 
several State legislatures have actually passed the enabling 
legislation for State PMPs with fiscal notes attached, indicating that 
they recognized the need for and usefulness of these programs but 
cannot fund them through State budgets. The timing of the fiscal year 
2004 grant solicitation and State prefiling deadlines coincided, 
allowing a significant increase in the number of eligible States to 
apply and receive awards. Congressional support for similar grant 
opportunities will continue to facilitate the growth of these programs.

Internet Pharmacies
    As I have previously mentioned in this testimony, States are 
concerned about the diversion of prescription drugs via illegal 
Internet sites. Federal assistance--specifically Federal-State 
partnerships--will be needed to effectively address this concern.

Federal Entities not Reporting to State PMPs
    In NAMSDL's work with States, they have alerted us to the 
dispensers of prescription drugs that are under Federal jurisdiction 
and thus not required to report to State PMPs: Veterans' Administration 
hospitals and medical facilities, facilities on military bases, and 
tribal Nations. While these entities are housed in States, they are not 
required to report designated prescription data to State PMPs. States 
have indicated that it would be helpful toward further curbing 
diversion and intervening early with people who may need appropriate 
addiction treatment to have dispensers from these entities to report 
data to these programs.

Evaluation
    Earlier in my remarks, I mentioned that there has not yet been a 
formal, science-based national evaluation of State PMPs. My 
understanding is that an evaluation design is being developed in 
conjunction with the BJA grant program. As more States consider 
establishing programs and the existing 19 States plan for sustaining 
their current monitoring systems, objective, concrete results from this 
national evaluation re: the effectiveness of PMPs will greatly help 
States justify the expenditure for these programs. Currently, States 
must focus on the need for reducing prescription diversion and 
addiction as well as anecdotal findings/experiences from other States' 
monitoring systems when working with decision makers to establish or 
sustain State PMPs. With Federal resources also facilitating the start-
up and enhancement of PMPs, this national evaluation will be 
instructive as to the best uses of these funds in the future (e.g., 
continued enhancements? technology project related to the PMPs? support 
to corollary systems such as addiction treatment?).
    Thank you once again for the opportunity to share this information 
with you. I would be happy to answer any questions that you have as the 
hearing proceeds.

    Senator Sessions. Dr. Varley, we are glad to have you here 
from Birmingham.
    Dr. Varley. Thank you. I would like to thank you, Senator 
Sessions, and all of the Committee Members and staff for this 
opportunity to testify regarding prescription drug monitoring 
programs. I would also like to extend a special note of 
gratitude to you personally and your staff for your assistance 
in this matter.
    I will sit here today in three capacities, the first as a 
representative and board member of the American Society of 
Interventional Pain Physicians. Our national organization 
represents nearly 50 percent of the 6,500 interventional pain 
physicians in America. Interventional pain management is that 
discipline of medicine devoted to the diagnosis and treatment 
of acute, sub-acute, and chronic pain and related disorders 
using interventional techniques in conjunction with other 
treatment modalities, including narcotic and psychotherapeutic 
medications. I would like to thank our national president, Dr. 
Lax Manchikanti, and our executive vice president, Dr. David 
Kloth, for their assistance in preparing this presentation.
    The second capacity is as an interventional pain physician 
licensed to practice in the State of Alabama.
    The third, and most important, as the father of three 
teenage girls, one of whom, Elizabeth, is present today to 
observe these proceedings.
    My thoughts and prayers----
    Senator Sessions. Maybe you would recognize her for us. 
Elizabeth? OK. I see her. We are glad you are here.
    Dr. Varley [continuing].  My thoughts and prayers are with 
those in Alabama and the Gulf Coast who are recovering from the 
devastation of Hurricane Ivan. The cost and destruction of 
Ivan, however, pales in comparison to the effect of 
prescription drug abuse and diversion in our society. I have 
provided supporting data and an extensive review in my formal 
presentation.
    Today, chronic pain requiring treatment affects 10 to 30 
percent of the population. Pain is second only to the common 
cold as the most frequent presenting complaint to a physician. 
Narcotic anagelsics and psychotherapeutic medications made 
available through our pharmaceutical industry have brought the 
treatment of pain within our grasp. Congress in its wisdom saw 
fit in 1970 to pass the Controlled Substances Act to control 
the manufacture and distribution of pharmaceutical substances. 
Unfortunately, despite this legislation, the diversion of 
legitimately prescribed medications has become such a problem 
that John Walters, Director of the White House Office of 
National Drug Control, states that, ``The nonmedicinal use of 
prescription drugs has become an increasingly widespread and 
serious problem in this country, one that calls for immediate 
action.''
    While most Americans recognize the risk of addiction and 
even death from illicit drugs, they are less likely to 
recognize the risks of prescription drugs. With increasing 
frequency, Americans have sought to divert prescription drugs 
for nonmedicinal purposes through theft, fraud, and forgery. 
With only 4.6 percent of the world's population, the United 
States consumes 80 percent of the world's opioid production. 
The problem of prescription drug diversion has eclipsed illicit 
drug use in public health and law enforcement challenge.
    Eleven million persons abused psychotherapeutic or 
analgesic medications in 2003, second only to marijuana as the 
leading category of illicit drugs. The exponential rise of the 
diversion of controlled substances is best exemplified by the 
nonmedicinal use of OxyContin, a time-release pain killer 
similar to morphine. In 1997, 221,000 persons abused this drug, 
but by 2003 this number had grown to 2.8 million. Abuse of 
these drugs in the chronic pain population is estimated to be 
between 18 and 24 percent. The diversion of prescription 
medications cuts across all parts of society without regard for 
race, religious, gender, age, or national origin. Several years 
ago, I performed a routine urine drug screen on a 67-year-old 
male suffering from postsurgical back pain. I was prescribing 
OxyContin, 40 milligrams 3 times a day, but only methadone 
could be found in his urine. He was selling his OxyContin, 
which was paid for by his insurance company, and buying 
methadone, which is much cheaper, to control his pain. The 
profit amounted to a $3,000-per-month supplement to his 
retirement income.
    Although most of the 30 million chronic pain patients are 
honest, from 3 to 8 million persons a year are trying to 
deceive physicians and divert prescription drugs. 
Unfortunately, the availability of diverted prescriptions is no 
more apparent than in our schools. Evidence shows that drugs 
are available as early as middle school and there is widespread 
sale and use in high schools. We see tragic case after case of 
disrupted teenage lives with social and family strife often 
leading to mental health crises and, unfortunately, death from 
overdose or suicide.
    The other end of the age spectrum was revealed in an 
article in the Birmingham News in May of this year. Two 66-
year-old grandmothers were charged with 12 counts of illegal 
sale of prescription medications--morphine, OxyContin, and 
hydrocodone--within 3 miles of a school. The director of the 
local drug task force said, ``The illegal use and sale of 
prescription medications has become one of the worst problems 
in [the county].''
    Prescription drug use is a national problem. The DEA 
controls the manufacture and wholesale distribution of 
controlled pharmaceuticals through a nationwide database. The 
retail level, from the physician to the patient, however, is 
not constantly being monitored State by State, and there is 
virtually no system in place to aid physicians in identifying 
unscrupulous patients trying to obtain medications under false 
pretenses. Some 15 to 21 States have some form of State 
prescription drug monitoring system. A monitoring system alone, 
however, will not give physicians the timely information needed 
to identify deceitful patients and stop diversion at its 
source. An effective monitoring system must be comprehensive, 
involving all 50 States, integrated, with all systems 
compatible and interconnected, involving all scheduled drugs 
and available in real time to give the physicians the 
information necessary to make good clinical decisions.
    The American Society of Interventional Pain Physicians 
strongly supports NASPER, the National All Schedules Electronic 
Recording Act, which incorporates all these elements and has 
been tested and proven effective in Kentucky.
    We ask that you support a system to give real-time, 
comprehensive information to physicians prescribing controlled 
substances. Help us put the control back into the Controlled 
Substances Act.
    Thank you again for providing me the opportunity to 
present, and now I will be happy to answer any questions at the 
appropriate time.
    Senator Sessions. Thank you, Dr. Varley, for that excellent 
testimony.
    [The prepared statement of Dr. Varley follows:]

             Prepared Statement Of Kenneth G. Varley, M.D.

    I would like to thank Senator Sessions and all the Committee 
Members and staff for this opportunity to testify regarding 
prescription drug monitoring programs. I sit here in three capacities.
    The first as a representative and Board member of the American 
Society of Interventional Pain Physicians. Our national organization 
represents nearly 50 percent of the 6,500 interventional pain 
physicians in America. Interventional pain management is that 
discipline of medicine devoted to the diagnosis and treatment of acute, 
sub acute and chronic pain and related disorders using interventional 
techniques in conjunction with other treatment modalities, including 
narcotic and psychotherapeutic medications. I would like to thank our 
national president, Dr. Lax Manchikanti and our executive vice-
president Dr. David Kloth for their assistance in preparing this 
presentation.
    The second as an interventional pain physician licensed to practice 
in the State of Alabama.
    The third and most important, as the father of three teenage girls, 
one of whom, Elizabeth, is present today to observe these proceedings.
    My thoughts and prayers are with those in Alabama and the gulf 
coast who are recovering from the devastation of hurricane Ivan. The 
cost and destruction of Ivan, however pales in comparison to the effect 
of prescription drug abuse and diversion in our society. I have 
provided supporting data and an extensive review in my formal 
submission.
    Today chronic pain requiring treatment affects 10-30 percent of the 
population. Pain is second only to the common cold as the most frequent 
presenting complaint to a physician. Narcotic analgesics and 
psychotherapeutic medications made available through our pharmaceutical 
industry have brought the treatment of pain within our grasp. Congress, 
in its wisdom, saw fit in 1970, to pass the Controlled Substances Act 
to control the manufacture and distribution of pharmaceutical 
substances. Unfortunately, despite this legislation, the diversion of 
legitimately prescribed medications has become such a problem that John 
Walters, Director of the White House Office of National Drug Control, 
stated that ``The non-medicinal use of prescription drugs has become an 
increasingly widespread and serious problem in this country, one that 
calls for immediate action.''
    While most Americans recognize the risk of addiction and even death 
from illicit drugs, they are less likely to recognize the risks of 
prescription drugs. With increasing frequency, Americans have sought to 
divert prescription drugs for non-medicinal purposes through theft, 
fraud and forgery. With only 4.6 percent of the world's population the 
United States consumes 80 percent of the world's opiod production. The 
problem of prescription drug diversion has eclipsed illicit drug use as 
a public health and law enforcement challenge.
    Eleven million persons abused psychotherapeutic or analgesic 
medications in 2003 second only to marijuana as the leading category of 
illicit drugs. The exponential rise of the diversion of controlled 
substances is best exemplified by the non-medicinal use of Oxycontin (a 
time release pain killer similar to morphine). In 1997 221,000 persons 
abused this drug but by 2003 this number had grown to 2.8 million. 
Abuse of these drugs in the chronic pain population is estimated to be 
between 18 and 24 percent. The diversion of prescription medications 
cuts across all parts of society without regard for race, religion, 
gender, age or national origin. Several years ago I performed a routine 
urine drug screen on a 67 year old male suffering from post surgical 
back pain. I was prescribing Oxycontin 40 mg 3 times a day but only 
methadone could be found in his urine. He was selling his Oxycontin, 
which was paid for by his insurance company, and buying methadone, 
which is much cheaper, to control his pain. The profit amounted to a 
$3,000 per month supplement to his retirement income.
    Although most of the 30 million chronic pain patients are honest, 
from 3 to 8 million persons a year are trying to deceive physicians and 
divert prescription drugs. Unfortunately, the availability of diverted 
prescriptions is no more apparent than in our schools. Evidence shows 
that drugs are available as early as middle school and there is 
widespread sale and use in high schools. We see tragic case after case 
of disrupted teenage lives with social and family strife often leading 
to mental health crises and unfortunately death from overdose or 
suicide.
    The other end of the age spectrum was revealed in an article in the 
Birmingham News in May of this year. Two 66 year old grandmothers were 
charged with 12 counts of the illegal sale of prescription medications, 
(morphine, Oxycontin and hydrocodone) within three miles of a school. 
The director of the local drug task force said, ``The illegal use and 
sale of prescription medications has become one of the worst drug 
problems in (the county).''
    Prescription drug use is a national problem. The DEA controls the 
manufacture and wholesale distribution of controlled pharmaceuticals 
through a nationwide database. The retail level, from the physician to 
the patient however, is not constantly being monitored State by State 
and there is virtually no system in place to aid physicians in 
identifying unscrupulous patients trying to obtain medications under 
false pretenses. Some 15 to 21 States have some form of State 
prescription drug monitoring system. A monitoring system alone however, 
will not give physicians the timely information needed to identify 
deceitful patients and stop diversion at its source. An effective 
monitoring system must be comprehensive, involving all 50 States, 
integrated, with all systems compatible and interconnected, involving 
all scheduled drugs and available in real time to give the physicians 
the information necessary to make good clinical decisions.
    The American Society of Interventional Pain Physicians strongly 
supports NASPER, the National All Schedules Electronic Recording Act 
which incorporates all these elements and has been tested and proven 
effective in Kentucky.
    We ask that you support a system to give real time comprehensive 
information to physicians prescribing controlled substances. Help us 
put the control back into the Controlled Substances Act.
    Thank you again for providing me with this opportunity. Now, I will 
be happy to answer any questions you may have.

                  Statement Of Kenneth G. Varley, M.D.

                                SUMMARY
                    PRESCRIPTION MONITORING PROGRAMS

    1. The management of pain is becoming a high priority in the USA.
    2. Controlled substance abuse and diversion is becoming a high 
priority.
    3. Drug abuse and diversion as a national problem.
    4. Drug abuse in chronic pain is a national problem.
    5. Management of abuse and diversion of controlled substance is a 
public health issue.
    6. Current state of affairs dictate the need for prescription 
monitoring programs.
    7. Problems facing physicians, patients, and law enforcement.
    8. The need for a comprehensive strategy to control drug abuse and 
diversion is increasing.
    9. National versus State control of controlled substances.
    10. A national program is feasible and cost-effective.
    The American Society of Interventional Pain Physicians is an 
organization representing interventional pain physicians and other 
health care professionals involved in interventional pain management. 
Our membership is over 2,900 at the present time. It is estimated that 
there are 6,500 interventional pain physicians across the country 
practicing interventional pain management. Interventional pain 
management, as per NUCC, is defined as--``the 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, even though not to the same 
extent as non-interventional pain physicians whose mainstay of 
treatment of chronic pain is controlled substances.

1. The management of pain is becoming a high priority in the USA.

     Chronic pain is prevalent in 10 percent of the population 
by conservative estimates and as high as 30 percent by liberal 
estimates.
     In the last several years, health policy-makers, health 
professionals, regulators and the public have become increasingly 
interested in the provision of better pain therapies.
     The United States population (294,277,501) constitutes 4.6 
percent of the world population (6,392,884,741).
         However, the United States with 4.6 percent of the 
world population consumes 80 percent of opioids from the world.
     Chronic pain involves multiple regions. After the initial 
onset of pain, more recent evidence shows that as many as 60 percent of 
the patients may continue to suffer with chronic pain after 1 year or 
even 12 years. This applies to children also.

2. Controlled substance abuse and diversion is becoming a high priority

     Non-medical uses of psychotherapeutics as described in 
multiple surveys include non-medical use of any prescription type:
         Pain relievers
         Tranquilizers
         Stimulants
         Sedatives
    This category does not include over-the-counter substances.
     This interest in managing chronic pain has led to the 
explosion of prescription of controlled substances, fueled by:
         Pharmaceutical companies providing marketing and 
gifts.
         Numerous organizations providing guidelines and 
standards.
         Patient advocacy groups demanding opioids for benign 
pain.
         Enactment of Patient's Bill of Rights in many States.
         JCAHO regulations mandating monitoring and appropriate 
treatment of pain.
         Patient's right to pain relief.
         Easy availability on internet.
         Perception of safety of prescription drugs.
     While the true extent of prescription drug abuse and 
diversion is unknown, estimates from a national survey indicate that 
the principle drug of abuse for nearly 10 percent of U.S. patients in 
treatment is a prescription drug.
     The most commonly abused drugs include oxycodone 
(Percodan, Percocet, Roxicet, Tylox, OxyContin), hydrocodone (Vicodin, 
Vicoprofen, Lorcet, Lortab), hydromorphone, morphine (Astramorph, 
Duramorph, MS Contin, Roxanol), codeine, clonazepam (Klonopin), 
alprazolam (Xanax), lorazepam (Ativan), diazepam (Valium) and 
carisoprodol (Soma).\1\
---------------------------------------------------------------------------
    \1\ 2003 National Survey on Drug Use and Health (NSDUH). Results 
from the 2003 National Survey on Drug Use and Health: National 
Findings. Department of Health and Human Services.
---------------------------------------------------------------------------
     Prescription drug abuse ranks second behind marijuana.
     John Walters, Director of the White House Office of 
National Drug Control Policy, said ``the non-medical use of 
prescription drugs has become an increasingly widespread and serious 
problem in this country, one that calls for immediate action.''
     Emergency room visits resulting from the abuse of narcotic 
pain relievers have jumped 163 percent since 1995.
     The proposed 2005 budget from the White House for 
prescription drug diversion control will increase by $20 million to 
$138 million. Most of the funds will be directed at reducing the non-
medical use of prescription drugs, mainly opioids.

3. Drug abuse and diversion as a national problem

    Results from the 2003 National Survey on Drug Use and Health showed 
the following:
     An estimated 6.3 million persons were current users of 
psychotherapeutic drugs taken non-medically, representing 2.7 percent 
of the population aged 12 or older.
     An estimated 4.7 million used pain relievers, 1.8 million 
used tranquilizers, 1.2 million used stimulants, and 0.3 million used 
sedatives.
     Pain reliever use has increased from 4.4 million in 2002 
to 4.7 million in 2003.
     There was a significant increase in lifetime non-medical 
use of pain relievers between 2002 and 2003 among persons aged 12 or 
older, from 29.6 million to 31.2 million.
     Specific pain relievers with statistically significant 
increase in lifetime use were hydrocodone products from 17.6 million in 
2002 to 21.4 million in 2003.
     Increases for OxyContin were from 1.9 million in 2002 to 
2.8 million in 2003. The following shows gradual increase of OxyContin 
over the years.



     An estimated 18.2 percent of unemployed adults aged 18 or 
older were current illicit drug users in 2003 compared with 7.9 percent 
of those employed full-time and 10.7 percent of those employed part-
time.
     Non-therapeutic use of pain reliever incidence increased 
from 1990 (573,000 initiates) to 2002 (2.5 million).
     There was a significant increase from 2002 to 2003 in the 
number of persons aged 12 or older with lifetime non-medical use of 
pain relievers, from 29.6 million to 31.2 million.



     There was an increase in past month non-medical use of 
pain relievers, from 4.1 percent in 2002 to 4.7 percent in 2003.



     New non-medical users of pain relievers have been 
increasing steadily since 1965 to 2002.



     The rate of current illicit drug use among youths aged 12 
to 17 was 11.2 percent in 2003.
     Dependency or abuse of specific substances among past year 
users of substances is high for prescription drugs, second only to 
heroin.



     Treatment for substance for which persons aged 12 or older 
received treatment in the past year is high based on 2003 survey.



     Prevalence of mental illness is almost double in patients 
with drug abuse.

4. Drug abuse in chronic pain management is a national problem

     The prevalence of chronic pain is estimated to be similar 
in all countries.
     Yet, the U.S. constituting 4.6 percent of the world 
population is consuming 80 percent of the opioids (Patricia Good--DEA 
Office of Diversion).
     An increasing number of studies have documented the 
relatively high incidence of controlled substance abuse and illicit 
drug use in patients undergoing treatment for chronic pain.
     The overall prevalence of controlled substance abuse in 
interventional pain management practice settings has been shown to be 
18 percent to 24 percent.
     Overall, illicit drug use in chronic pain patients has 
been shown to be 14 percent to 16 percent in patients without 
controlled substance abuse, and 34 percent in patients with controlled 
substance abuse.
     With conservative estimates of chronic pain of 10 percent 
in the United States (approximately 20 to 25 million persons), the 
prescription drug abuse or misuse is seen in 18 percent to 24 percent 
(approximately 3 million to 8 million persons).
     Almost all (90 percent to 95 percent) of the patients 
presenting for evaluation in interventional pain management settings 
are already on heavy doses of controlled substances and we are unable 
to take them off of these drugs.

5. Management of abuse and diversion of controlled substance is a 
                    public health issue

     The diversion and abuse of prescription drugs are 
associated with incalculable costs to society in terms of addiction, 
overdose, death, and related criminal activities.
     The DEA has stated that the diversion and abuse of 
legitimately produced controlled pharmaceuticals constitute a multi-
billion dollar illicit market nationwide.\2\
---------------------------------------------------------------------------
    \2\ Drug Enforcement Administration and the National Alliance for 
Model State Drug Laws, A Closer Look at State Prescription Monitoring 
Programs (http://www.deadiversion.usdoj.gov/pubs/program/prescription-
monitor/summary.htm).
---------------------------------------------------------------------------
     As of February 2002, OxyContin has been involved in 464 
deaths from prescription drug abuse, as reported by DEA on the basis of 
medical examiners autopsy findings for 2000 and 2001 from 32 States and 
increasing.
     Numerous methadone deaths have been reported.
     Patients may be receiving Schedule II, III, and IV 
prescriptions from multiple practitioners who are unaware of the 
potential for drug interactions or of the potential for abuse, and 
diversion of certain medications.
     Drug spending is skyrocketing. Significant amounts of 
Medicaid funds are spent on abused drugs. Drug spending in some States 
has increased by 65 percent in 2003.
     Source of payment for specialty treatment or drug abuse 
and addiction treatment is highest for Federal funds:



     Projected economic cost of drug abuse for 1998 through 
2000 has been shown by Levin group as 143.4 billion for 1998, 152.5 
billion for 1999, and 160.7 billion for 2000.
     The Office of the National Drug Control Policy estimated 
the economic cost of drug abuse in the United States from 1992 to 1998 
with overall cost of drug abuse to society increasing at a rate of 5.9 
percent annually with healthcare costs of $14.9 billion in 2000.
     A 1995 study by the Center on Addiction and Substance 
Abuse of the cost of substance abuse to Federal entitlement programs 
found that healthcare and disability costs alone were 17.6 billion, 
representing nearly 20 percent of the Federal healthcare budget. In 
this study, the cost to the Medicaid program resulting from substance 
abuse were enormous--in 1994, accounting for almost $8 billion in 
Medicaid expenditures.
     A significant number of Medicaid recipients have been 
shown to abuse drugs varying from 9.4 percent to 16.14 percent in the 
Medicaid program, with prevalence of 15.5 percent functional impairment 
due to drug abuse.
     A 2004 study by the Luo et al. (Spine 2004) showed that 
there was an increased risk in women and patients of low economic 
status for non-medical use of psychotherapeutic drugs. These factors 
are important in Medicaid as the majority constitute women and men of 
low socioeconomic status.
     In a study performed by Manchikanti et al. (Kentucky 
Medical Association Journal--in press), patients on Medicaid as their 
primary insurance or in conjunction with Medicare showed significant 
incidence of drug abuse.
         Patients covered by third party insurance showed 17 
percent prevalence of illicit drug use, with patients on Medicare with 
or without third party insurance, showing 10 percent illicit drug use.
         Patients on Medicare and Medicaid showed illicit drug 
use in 24 percent.
         Patients only on Medicaid showed illicit drug use in 
39 percent of the patients.
         Combined use of illicit drugs and misuse of 
prescription drugs was seen in 60 percent of the patients only on 
Medicaid and 40 percent of the patients with Medicare and Medicaid.

6. Current state of affairs dictate the need for prescription 
                    monitoring programs

     The increasing diversion of prescription drugs for illegal 
use is a disturbing trend in the Nation's battle against drug use and 
abuse.
     Prescription drug diversion is the channeling of 
pharmaceuticals for illegal purposes or abuse. It can involve 
activities such as ``doctor shopping'' by individuals who visit 
numerous physicians to obtain multiple prescriptions, illegal sales of 
prescription drugs by physicians or pharmacists, and prescription 
forgery.
     States have recognized the need for monitoring of 
controlled substances since 1940 with implementation in California 
followed by Hawaii in 1943 (Table 1). Now, 15 States have such 
programs, which include California, Hawaii, Idaho, Illinois, Indiana, 
Kentucky, Massachusetts, Michigan, Nevada, New York, Oklahoma, Rhode 
Island, Texas, Utah, and Washington State.
     Florida and Virginia are actively pursuing such programs.
     GAO in its May 2002 report of State monitoring programs 
concluded that:
         They indeed provide an efficient tool for stemming the 
growing problem of illegal diversion of prescription drugs.
         They offer quick access to comprehensive information 
on drugs most likely to be abused and deter abusers from doctor 
shopping within the State.
         Incidences of drug diversion, however, are on the rise 
in neighboring States, indicating the problem is proliferating or 
shifting to States without monitoring programs.
         The programs have helped reduce availability of abused 
drugs in Kentucky, Nevada, and Utah.
     State prescription monitoring programs reduce expenses to 
healthcare officials, pharmacists, and law enforcement officials.
     State programs have helped shorten investigation time and 
reduce illegal drug diversion.

7. Problems facing physicians, patients and law enforcement

    i. Problems facing physicians
     Every day a physician has to consider:
         Litigation for failure to treat pain
         Litigation for undertreatment
         Criminal charges for abuse, addiction, or death
         Numerous Federal regulations
         State Board of Medical Examiners
         Drug Enforcement Agency
         State Bureau of Narcotics
         State Board of Pharmacy
     Problems in Alabama
         Based on the DEA fact sheet of 2004, Alabama continues 
to see an increase in diverted pharmaceuticals across the State.
         OxyContin is still the number one pharmaceutical drug 
abused across the State.
         The sale and production of Vicodin has increased in 
recent years slightly, along with the illegal use of the drug.
     In addition, current intelligence and investigations 
indicate that Alabama is a major market for Dilaudid. Distribution in 
Alabama has increased due to the fact that the price of heroin in the 
New York area has fallen dramatically causing the bottom to fall out of 
the market for Dilaudid. Distribution organizations are targeting the 
metropolitan areas of Alabama, as the price they receive for Dilaudid 
is higher in Alabama than in the source areas.
     Options for Physicians:
         Referral to Pain Medicine Clinics
           Clinics with mainstay treatment of opioids
           Very limited resource
           Rare option for Interventional Pain Specialists
         Refuse to Prescribe Controlled Substances
           Not an option for many practices
           Inadequate treatment of pain lawsuits
           Litigation for addiction
           Criminal charges of murder
         Surrender Schedule II DEA License
           Lose many patients
           Lose hospital privileges
           Lose all insurance patients
           Not an option for interventionalists
     Benefits for Physicians:
         NASPER could alert physicians about patients who are 
drug shopping.
         Physician can make more informed decisions on 
prescribing, leading to less risk for medical license.
         Decreased hassle factor with DEA, Medical Board and 
U.S. Attorneys.
    ii. Problems facing patients
     Undertreatment of pain
     Suspicion may not be resolved
     Patients who are drug shopping will benefit from physician 
intervention.
     Patients who are not drug shopping will benefit from 
physician ability to feel more comfortable in prescribing medicines 
they need.
     Benefits for Patients:
         Improved access
         Stable patient-physician relationship
    iii. Law Enforcement
     Court cases involving possession and trafficking in 
controlled substances is increasing rapidly across the Nation.
     In one county in Eastern Kentucky, a 350 percent increase 
was noted in 4 years.
     Law enforcement officials are reporting an increasing 
number of DUIs related to drugs than to alcohol.
     Substance abuse residential houses are not able to cope 
with the number of patients on drugs.
     More than 1 in 10 inmates have been committed due to an 
offense related to drugs.
     The DEA, medical boards, and other authorities are 
struggling to contain drug abuse and related consequences.
     NASPER will benefit not only patients and physicians by 
improving access to care and improving the quality of care but also 
will assist law enforcement by punishing the trafficking patients, and 
physicians who inappropriately prescribe or abuse drugs.

8. The need for a comprehensive strategy to control drug abuse and 
                    diversion is increasing

    While State programs have been effective, the following 
deficiencies have been noted:
     From 1940 to 1999, States have been able to establish only 
15 functioning programs. The number of States with prescription drug 
monitoring programs has grown only slightly over the past decade, from 
10 in 1992 to 15 in 2002.
     The White House estimates to increase drug monitoring 
programs by 10 next year.
     The nationwide number of prescription drug monitoring 
programs has been changing. West Virginia terminated its program in 
1998, but enacted legislation in 2002 to create a new program. New 
Mexico terminated its program in 2000 (Figure 1).
     Even though the 15 programs have a common goal of reducing 
prescription drug diversion and abuse, they vary in their objectives, 
design, and operation.
     The major purpose of the State programs is to help law 
enforcement identify and prevent prescription drug diversion.
     Education objectives to provide information to physicians, 
pharmacies, and the public is a secondary objective.
     Very few States are proactive to the extent that 
physicians can access the information proactively to reduce or prevent 
abuse and diversion.
     Program design also varies across States, in terms of 
which drugs are covered, how prescription information is collected and 
which agency is given responsibility for the program.
     Methods for analyzing the data to detect potential 
diversion activity also differ among States.
     Only 4 of 15 States monitor Schedule IV drugs and only 5 
of 15 monitor Schedule III drugs which are the subject of major-
controlled substance abuse.
     Challenges exist in establishing and expanding State 
programs, due to lack of awareness of the extent to which prescription 
drug abuse and diversion is a significant public health and law 
enforcement problem.
     Extent of diversion in abuse is not always recognized by 
the States.
     National efforts have focused only on providing guidance 
and technical assistance.
     Incidents of drug diversion, however, are on the rise in 
neighboring States, indicating the problem is proliferating or shifting 
to States without monitoring programs.

9. Federal versus State control of controlled substances

    i. Federal
     Controlled Substances Act. The Controlled Substances Act 
established a classification structure for drugs and chemicals used in 
the manufacture of drugs that are designed as controlled substances.
     FDA regulations of prescription drugs. The FDA is 
responsible for ensuring that all new drugs are safe and effective.
     The DEA's regulation of controlled substances. The DEA is 
the primary Federal agency responsible for enforcing the Controlled 
Substances Act. The DEA has the authority to regulate transactions 
involving the sale and distribution of controlled substances at the 
manufacturer and wholesale distributor levels.
     Guidelines for marketing drugs to healthcare 
professionals. In April 2003, HHS's Office of Inspector General issued 
voluntary guidelines for how drug companies should market and promote 
their products to Federal healthcare programs. Federal funds are spent 
through Medicare/Medicaid military health and other assistance programs 
spent by patients in acquiring drugs and also in drug treatment.
     Federal funds utilized for management diversion. Thus, 
drugs are mostly controlled by Federal agencies rather than State 
agencies.
    ii. State
     The State's regulation of practice of medicine and 
pharmacy and role in monitoring illegal use and diversion of 
prescription drugs. State laws govern the prescribing and dispensing of 
prescription drugs by licensed healthcare professionals.
     Multiple State agencies have responded to reports of drug 
abuse. However, complete information is not available from the 
directors of State Medicaid fraud control units in Kentucky, Maryland, 
Pennsylvania, Virginia, and West Virginia. They stated that drug abuse 
and diversion of OxyContin is a problem in these States.
     State Medical Licensure Boards have also responded to 
complaints about physicians who were suspected of abuse and diversion 
of controlled substances, but like the Medicaid Fraud Control Units, 
the Boards generally do not maintain data on the number of 
investigations that were involved.
         Although Medical Boards may be tough, they can't 
always catch the bad apples.
         Kentucky's Board of Medical Licensure ranked fifth in 
the Nation for disciplining physicians in 2001.
         Board reacts to complaints and can't statutorily look 
for problems on its own.
    In contrast, the DEA has statistics available on drug abuse and 
diversion. Overall, Federal control and responsibility outweighs 
States.

10. A national program is feasible and cost-effective

     The cost of the program in each State varies according to 
differences in their design and operational factors.
     Confidentiality appears to be a major concern. Both 
physicians who legitimately prescribe prescription drugs and patients 
who legitimately use them are concerned that the information collected, 
maintained, and monitored by State programs may be used inappropriately 
or compromised.
         All States, regardless of whether there is a State 
prescription monitoring program or not, have the authority under their 
laws to conduct investigations of the records of individuals alleged to 
be involved in prescription drug diversion and abuse, including the 
records of prescribing physicians and dispensing pharmacies.
     According to GAO, securing program funding is a critical 
challenge. The 2002 report states that according to officials from the 
National Alliance for Model State Drug Laws, the National Association 
of Drug Diversion investigators, and the DEA, securing program funding 
is a critical challenge faced by States that choose to develop, 
maintain, or expand a prescription drug monitoring program.
     A national comprehensive program with individual State 
authority with communication among programs with uniform data 
collection dispersion and ability for physicians to access the data 
will reduce drug abuse and diversion and at the same time, provide 
appropriate pain management. There are approximately 60,000 pharmacies 
across the United States covering half a million prescriptions per 
year.
     A national program with a collection of State programs 
will be cost effective. Table 2 shows the contiguous States for each of 
the 50 States.
     As per the available data from the 2002 GAO report, 
describing key features of selected State prescription drug monitoring 
programs as shown in Table 3, the set of funding was $415,000 in 
Kentucky, $134,000 in Nevada, and $50,000 in Utah. The annual operating 
costs consecutively for the 3 States was $500,000, $112,000 and 
$150,000.




                     Table 1. Characteristics of State prescription drug monitoring programs
----------------------------------------------------------------------------------------------------------------
                                                          Controlled
                                                           substance      Type of monitoring    Administrative
              State                Year Implemented       schedule(s)           system              Agency
                                                           monitored
----------------------------------------------------------------------------------------------------------------
California a....................  1940..............  II................  Electronic and      Pharmacy and law
                                                                           triplicate form b.  enforcement.
Hawaii..........................  1943..............  II................  Electronic........  Law enforcement.
Idaho...........................  1967..............  II, III, and IV...  Electronic........  Pharmacy board.
Illinois........................  1961..............  II................  Electronic........  Public health.
Indiana.........................  1995..............  II................  Electronic........  Law enforcement.
Kentucky........................  1999..............  II, III, IV and V.  Electronic........  Public health.
Massachusetts...................  1992..............  II................  Electronic........  Public health.
Michigan c......................  1989..............  II................  Single form.......  Commerce.
Nevada..........................  1997..............  II, III, and IV...  Electronic........  Pharmacy board and
                                                                                               law
                                                                                               enforcement.
New York d......................  1977..............  II................  Electronic........  Public health.
Oklahoma........................  1991..............  II................  Electronic........  Law enforcement.
Rhode Island....................  1979..............  II, III...........  Electronic........  Public health.
Texas e.........................  1982..............  II................  Electronic........  Law enforcement.
Utah............................  1997..............  II, III, IV, and V  Electronic........  Commerce's
                                                                                               Licensing
                                                                                               Division.
Washington f....................  1987..............  Determined by       Triplicate form b.  Public health.
                                                       disciplinary
                                                       authority.
----------------------------------------------------------------------------------------------------------------
a California is currently testing an electronic monitoring program for Schedule II controlled substances. Until
  the pilot program is completed on July 1, 2003, pharmacies will also have to continue submitting copies of the
  triplicate forms to the State monitoring agency.
b A triplicate prescription form is a paper prescription form issued by the State to prescribers, who must use
  it when writing prescriptions for covered controlled substances. The prescriber keeps one copy after writing
  the prescription, and the pharmacist keeps a copy when the prescription is filled and sends the third copy to
  the state PDMP.
c In 2001, Michigan enacted legislation to convert its PDMP to an electronic monitoring program. Until the new
  electronic system is implemented, the program will continue to require pharmacies to submit copies of State-
  issued official prescription forms for schedule II controlled substances.
d As of January 1, 2002, New York switched to an electronic monitoring system from a paper-based system using a
  triplicate form. The new electronic system is supplemented by a State-issued, single-copy prescription form
  that includes a number of security features to prevent counterfeits.
e Beginning in September 1999, Texas permitted pharmacies to submit prescription data electronically rather than
  submitting paper copies of prescription forms. In March 2002, Texas switched from triplicate to single-copy
  forms with a number of security features to prevent counterfeits. The requirement to submit prescription forms
  to the State agency will continue until the electronic system is fully implemented.
f The Washington program applies only to licensed practitioners whose prescribing practices require monitoring
  because of the past drug abuse or inappropriate prescribing. The drugs the program covers vary, depending on
  the prescriber, from one controlled substance to all prescriptions.
Source: National Alliance for Model State Drug Laws. Information is current through February 4, 2002.


     Table 2. Shows the contiguous States for each of the 50 States
------------------------------------------------------------------------
                 State                          Surrounding States
------------------------------------------------------------------------
Alabama................................  Florida, Georgia, Mississippi,
                                          Tennessee.
Alaska.................................  None.
Arizona................................  California, Colorado, New
                                          Mexico, Nevada, Utah.
Arkansas...............................  Louisiana, Missouri,
                                          Mississippi, Oklahoma,
                                          Tennessee, Texas.
California.............................  Arizona, Nevada, Oregon.
Colorado...............................  Arizona, Kansas, Nebraska, New
                                          Mexico, Oklahoma, Utah,
                                          Wyoming.
Connecticut............................  Massachusetts, New York, Rhode
                                          Island.
Delaware...............................  Maryland, New Jersey,
                                          Pennsylvania.
Washington DC..........................  Maryland, Virginia.
Florida................................  Alabama, Georgia.
Georgia................................  Alabama, Florida, North
                                          Carolina, South Carolina,
                                          Tennessee.
Hawaii.................................  None.
Idaho..................................  Montana, Nevada, Oregon, Utah,
                                          Washington, Wyoming.
Illinois...............................  Iowa, Indiana, Kentucky,
                                          Missouri, Wisconsin.
Indiana................................  Illinois, Kentucky, Michigan,
                                          Ohio.
Iowa...................................  Illinois, Minnesota, Missouri,
                                          Nebraska, South Dakota,
                                          Wisconsin.
Kansas.................................  Colorado, Missouri, Nebraska,
                                          Oklahoma.
Kentucky...............................  Illinois, Indiana, Missouri,
                                          Ohio, Tennessee, Virginia,
                                          West Virginia.
Louisiana..............................  Arkansas, Mississippi, Texas.
Maine..................................  New Hampshire.
Maryland...............................  District Of Columbia, Delaware,
                                          Pennsylvania, Virginia, West
                                          Virginia.
Massachusetts..........................  Connecticut, New Hampshire, New
                                          York, Rhode Island, Vermont.
Michigan...............................  Indiana, Ohio, Wisconsin.
Minnesota..............................  Iowa, North Dakota, South
                                          Dakota, Wisconsin.
Mississippi............................  Alabama, Arkansas, Louisiana,
                                          Tennessee.
Missouri...............................  Arkansas, Iowa, Illinois,
                                          Kansas, Kentucky, Nebraska,
                                          Oklahoma, Tennessee.
Montana................................  Idaho, North Dakota, South
                                          Dakota, Wyoming.
Nebraska...............................  Colorado, Iowa, Kansas,
                                          Missouri, South Dakota,
                                          Wyoming.
Nevada.................................  Arizona, California, Idaho,
                                          Oregon, Utah.
New Hampshire..........................  Massachusetts, Maine, Vermont.
New Jersey.............................  Delaware, New York,
                                          Pennsylvania.
New Mexico.............................  Arizona, Colorado, Oklahoma,
                                          Texas, Utah.
New York...............................  Connecticut, Massachusetts, New
                                          Jersey, Pennsylvania, Vermont.
North Carolina.........................  Georgia, South Carolina,
                                          Tennessee, Virginia.
North Dakota...........................  Minnesota, Montana, South
                                          Dakota.
Ohio...................................  Indiana, Kentucky, Michigan,
                                          Pennsylvania, West Virginia.
Oklahoma...............................  Arkansas, Colorado, Kansas,
                                          Missouri, New Mexico, Texas.
Oregon.................................  California, Idaho, Nevada,
                                          Washington.
Pennsylvania...........................  Delaware, Maryland, New Jersey,
                                          New York, Ohio, West Virginia.
Rhode Island...........................  Connecticut, Massachusetts.
South Carolina.........................  Georgia, North Carolina.
South Dakota...........................  Iowa, Minnesota, Montana, North
                                          Dakota, Nebraska, Wyoming.
Tennessee..............................  Alabama, Arkansas, Georgia,
                                          Kentucky, Missouri,
                                          Mississippi, North Carolina,
                                          Virginia.
Texas..................................  Arkansas, Louisiana, New
                                          Mexico, Oklahoma.
Utah...................................  Arizona, Colorado, Idaho, New
                                          Mexico, Nevada, Wyoming.
Vermont................................  Massachusetts, New Hampshire,
                                          New York.
Virginia...............................  District Of Columbia, Kentucky,
                                          Maryland, North Carolina,
                                          Tennessee, West Virginia.
Washington.............................  Idaho, Oregon.
West Virginia..........................  Kentucky, Maryland, Ohio,
                                          Pennsylvania, Virginia.
Wisconsin..............................  Iowa, Illinois, Michigan,
                                          Minnesota.
Wyoming................................  Colorado, Idaho, Montana,
                                          Nebraska, South Dakota, Utah.
------------------------------------------------------------------------


                  Table 3. Key features of selected state prescription drug monitoring programs
----------------------------------------------------------------------------------------------------------------
             Key features                      Kentucky                  Nevada                    Utah
----------------------------------------------------------------------------------------------------------------
Census 2000 population...............  4.04 million...........  1.99 million...........  2.23 million.
Year operational.....................  1999...................  1997...................  1997.
Start-up funding.....................  $415,000 in Federal      $134,000 a in State      $50,000 in one time
                                        start-up grant funds.    funds.                   State funds.
Controlled substance schedules         II, III, IV, V.........  II, III, IV............  II, III, IV, V.
 monitored.
Electronic data collection and         Yes....................  Yes....................  Yes.
 reporting.
Private contractor receives            Yes....................  Yes....................  No.
 dispensing information and creates
 database.
Annual operating costs (estimate)....  $500,000...............  $112,000...............  $150,000.
Staff................................  4 full-time (1 licensed  1 full-time with all     3 full-time including
                                        pharmacist               administrative duties.   manager and 2 support
                                        investigator, 2                                   staff.
                                        pharmacy technicians,
                                        1 data entry operator)
                                        and 4 part-time.
Number of pharmacies reporting         1,300..................  387....................  375.
 dispensing data (estimate).
Number of daily data requests          400....................  20.....................  130 to 150.
 received (estimate).
Report turnaround time to requestor    4 hours................  4 hours................  3 hours.
 (estimate).
Penalty for unauthorized use or        Class D felony b.......  PDMP statue has no       Third-degree felony.c
 disclosure of PDMP data.                                        penalty.
----------------------------------------------------------------------------------------------------------------
a Nevada received $265,000 for the first 2 years of its program's operations, including 2-year grants from two
  pharmaceutical companies and the State board of medical examiners.
b Kentucky law defines a class D felony as one carrying a sentence of at least 1 year, but not more than 5 years
  in prison.
c Utah law defines a third-degree felony as one carrying a sentence of not more than 5 years in prison.
Source: GAO interviews with PDMP administrators.


    Senator Sessions. Ms. Pritts, get that microphone there, 
and we would be delighted to hear from you at this time.
    Ms. Pritts. Good afternoon, Senator Sessions. I would like 
to thank you and the committee for inviting me here to testify 
today about the privacy considerations of prescription drug 
monitoring programs.
    As we have heard from earlier witnesses, there is growing 
support for some Federal support for comprehensive and 
compatible State prescription drug monitoring programs. This is 
an admirable goal, and it appears that the State-based programs 
have been fairly successful in actually reducing prescription 
drug diversion and abuse. However, it is crucial to have 
adequate privacy protections in place as we look to expand 
these programs and to electronically link them.
    My written testimony goes into quite a bit of detail about 
what Federal standards should look like if the Federal 
Government decides to support these programs through funding. 
There should be minimum Federal standards. Many States already 
have privacy protections in their State laws, but they do vary 
from State to State. If you are looking to share information 
across State lines, protections should be somewhat at least at 
a minimum level across the board.
    Now, the reason why this is necessary is that HIPAA and 
other Federal privacy statutes generally do not cover 
prescription drug monitoring programs. There often is a 
misconception that the HIPAA privacy rule covers most people 
who hold and maintain medical information, but that is not the 
case.
    My written testimony goes into the specific types of 
standards that States should be required to follow if they 
would request Federal funding, including notice; an 
individual's right of access to their own information; a right 
to correct that information if it is inaccurate, which is 
particularly important when you are talking about this type of 
information; restrictions on disclosures for recipients of 
information, this is an area that actually is lacking at the 
State level.
    Perhaps, however, one of the largest privacy issues that I 
see arising from this whole circumstance is the manner in which 
identifiable data is transmitted and stored. The system that 
seems to be developing seems to be based on these large 
databases, either at the State level or there is some thought 
of even kind of a regional level if States elect not to 
participate in the system.
    Maintaining data in this format has been seen by many 
people in the security field as being problematic, and it is 
problematic both in principle and in practice.
    In principle, there are a lot of citizens in the United 
States who have a visceral negative reaction to government 
collecting and storing information in a central database. 
Florida is a perfectly good example of that. The Florida 
Legislature earlier this year tried and failed to pass a 
prescription drug monitoring bill which included a central 
database. The opponents compared the proposed database to 
databases maintained by communist Cuba. Now, these comments 
were not made by just your ordinary citizens. This particular 
comment came from one of the Republican Representatives. So you 
can see that there are very strong feelings on this issue by a 
number of the population, and linking data and having a 
comprehensive database will have to overcome those feelings in 
order to be successful.
    Those feelings are not just based in principle, however. 
There are, as a matter of practice, some serious problems with 
maintaining data in this type of database. And, unfortunately, 
I am going to have to use Florida again as an example here. In 
the mid-1990s, using a similar database, in Florida doctors are 
required to report by name people who have been diagnosed with 
AIDS, and that data is maintained in a database with 
identifiable information. The patient's name, for example, is 
associated with it. And a county employee downloaded 4,000 
names of AIDS patients, put them on a diskette, and was using 
it for his own personal dating purposes and also was basically 
threatening blackmail to release it to the newspapers.
    When you have information that is concentrated in this type 
of a database, particularly depending on what kind of 
identifiers you might have associated with it, it becomes a 
very large temptation for people to act badly, not only hackers 
but people who have authorized access to the information.
    One of the ways that they have gotten around this issue in 
the actual health care practice right now is to encrypt the 
data or to have certain types of linking done. I am not a 
technology expert, but I have heard presentations given, 
particularly by Dr. John Halamka, who runs the New England 
Health Electronic Data Interchange Network, and they have a 
system there that does not require the use--you can identify 
people on a need-to-know basis, but the information is not 
stored using identifiers that are easily picked out by people 
who would improperly access the system or improperly want to 
use the system.
    So I would urge as we go forward here that some of these 
alternative technologies be considered. Oftentimes what happens 
in this field is that we start down one path, technology 
changes, and there has been a lot of commitment and money to 
one path, and so people are reluctant to change. And I do 
appreciate that. But to the extent that there is an opportunity 
to think of other ways of doing things, this would be a good 
time to start those thought processes.
    Adopting these kinds of privacy protections, including 
encrypting data or storing it in a nonidentifiable basis, will 
ease some of the privacy concerns that people have over 
establishing these programs and may ease the road into going 
forward in this area.
    Thank you.
    Senator Sessions. Thank you very much. You raise some 
matters that we need to discuss.
    [The prepared statement of Ms. Pritts follows:]

               Prepared Statement Of Joy L. Pritts, J.D.

I. Introduction

    Mr. Chairman and Members of the Committee on Health, Education, 
Labor, and Pensions: Thank you for the opportunity to testify before 
you today on the need for adequate privacy protections in prescription 
drug monitoring programs.
    My name is Joy Pritts. I am an assistant research professor at 
Georgetown University's Health Policy Institute. My work at Georgetown 
focuses on laws, policies, and practices related to the privacy of 
medical information.
    The non-medical use of prescription drugs continues to be a 
widespread and serious problem in this country. As part of the effort 
to control the illegal diversion of prescription drugs, many States 
have instituted prescription drug monitoring programs. These programs 
collect, review, and analyze identifiable prescription data from 
pharmacies. Although the programs differ in terms of objectives, 
design, and operation, they generally analyze and distribute collected 
information to medical practitioners, pharmacies, and regulatory and 
law enforcement agencies.\1\ Many of these programs have been 
successful at reducing diversion within their States. It is not 
surprising that expanding the number of State prescription drug 
monitoring programs and ensuring that they are able to share data 
across State lines are key elements of the Federal strategy to reduce 
prescription drug abuse nationwide.\2\
---------------------------------------------------------------------------
    \1\ 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).
    \2\ See the White House, National Drug Control Strategy (March 
2004) available online at www.whitehousedrugpolicy.gov/publications/
policy/ndcs04/index.html.
---------------------------------------------------------------------------
    While the goals of these programs are admirable, increasing the 
number of prescription drug monitoring programs that are able to share 
identifiable information electronically raises serious privacy 
concerns. Millions of Americans suffer from chronic pain. Without 
adequate privacy safeguards, patients will not seek treatment and 
practitioners will be hesitant to adequately prescribe medication.\3\ 
Absent strong privacy protections, there may well be wide-spread public 
resistance to linking prescription drug monitoring program data.
---------------------------------------------------------------------------
    \3\ See Gao, Prescription Drugs: State Monitoring Programs at 5.
---------------------------------------------------------------------------

II. There Should Be Federal Privacy Standards for Prescription Drug 
                    Monitoring Programs

    Federal proposals to encourage the expansion and linkage of State 
prescription drug monitoring programs should establish minimum, uniform 
privacy standards for these programs based on well-established fair 
information practice principles. Federal privacy standards for 
prescription drug monitoring programs are essential because these 
programs generally are not subject to the Federal Privacy Rule issued 
under the Health Insurance Portability and Accountability Act of 1996 
(HIPAA Privacy Rule). The Privacy Rule only governs three major 
categories of entities that maintain identifiable health information 
called ``covered entities'': health care providers; health care 
clearinghouses; and health plans.\4\ Most State programs are 
administered by a State board of pharmacy, a State department of 
health, or a State law enforcement agency. As a general rule, these 
entities are not subject to the restrictions imposed by the HIPAA 
Privacy Rule.
---------------------------------------------------------------------------
    \4\ 45 C.F.R. 164.500 (applicability of Privacy Rule to covered 
entities) and 160.103 (defining covered entity).
---------------------------------------------------------------------------
    While States generally have some privacy protections for 
prescription drug monitoring program data, these protections can vary 
widely from State to State. For example, some States impose a criminal 
penalty for unauthorized use or disclosure of prescription drug 
monitoring program information and others do not. Linking data between 
States with differing standards can result in decreased privacy 
protections for citizens of States with stringent privacy laws. 
Citizens should not lose privacy protections as a result of States' 
sharing data. As a practical matter, States with high privacy standards 
may be reluctant to share data with States that have less privacy 
protections.
    Establishing Federal minimum privacy standards for prescription 
drug monitoring programs can help ease these concerns. While States 
should remain the primary regulators of prescription drug monitoring 
programs, any Federal funds for such programs should be tied to the 
requirement that State programs meet minimum Federal privacy standards. 
States should remain free to impose higher privacy standards to meet 
the particular needs of their citizens.
    At a minimum such Federal standards should:
     Provide individuals specific notice that certain 
prescription drug information will be reported to a State prescription 
drug monitoring program and may be shared with programs of other 
States.
     Provide individuals with a right of access to their 
information that is maintained in a State prescription drug monitoring 
program and the right to contest the accuracy of the information.
     Limit the information provided under these programs to the 
minimum amount necessary to accomplish the intended purpose.
     Require recipients of information from prescription drug 
monitoring programs to only use the information for the purpose for 
which it was disclosed and prohibit them from further disclosing the 
information.
     Establish safeguards for verifying the accuracy of 
reported information.
     Establish security standards for maintaining and 
transmitting data.
     Require requests for inspection from most law enforcement 
agencies to be reviewed and approved by appropriate officials prior to 
disclosure.
     Require the de-identification of information provided for 
statistical, research, or educational purposes.
     Impose stringent civil and criminal penalties on the 
improper use and disclosure of prescription drug monitoring program 
data.
    To the extent the Federal Government determines that it will 
directly operate prescription drug monitoring programs, these standards 
should also apply to the Federal program. The restrictions in the 
Privacy Act are insufficient.

Notice

    Practitioners and/or dispensers of prescription drugs should be 
required to give individuals adequate notice that information related 
to prescriptions for certain classes of drugs will be reported to the 
State's prescription drug monitoring program. Individuals should be 
informed of who will have access to this information and the purposes 
for which they can use the information. Giving notice avoids any 
potential of ``secret'' databases. As a practical matter, adequate 
notice should also have a direct deterrent effect on ``doctor 
shopping'' because potential diverters will be made aware that their 
prescription drug information will be reviewed by the program and 
shared with other practitioners.
    Most health care providers such as doctors and pharmacists already 
are required to give patients a notice of privacy practice under the 
HIPAA Privacy Rule. The HIPAA Privacy Rule, however, only requires a 
general notice of privacy practices that includes certain examples.\5\ 
To be an effective deterrent, notice under the prescription drug 
monitoring program would need to specifically advise consumers that if 
they have certain prescriptions filled, their prescription information 
will be reported to the State monitoring program. Thus, notice under 
the prescription drug monitoring program should be in addition to the 
notice required by the Federal Privacy Rule.
---------------------------------------------------------------------------
    \5\ See 45 C.F.R. 164.520.
---------------------------------------------------------------------------

Access

    Individuals should have the right to access and contest their 
identifiable data that is maintained in a prescription drug monitoring 
program. The right of access ensures that identifiable information is 
accurate and complete. Due to the sensitive nature of prescription drug 
information, it is particularly important that data collected be 
associated with the proper person.

Minimum Information

    Only the minimum amount of information necessary to accomplish the 
intended purpose should be disclosed to recipients of information from 
prescription drug monitoring programs. This determination can be made 
at the policy level. The standard should apply not only to information 
that is requested of the program but also to any disclosures that are 
made as a matter of routine.

Restrictions on Recipients of Information

    Federal standards should require recipients of prescription drug 
monitoring program information to use the information only for the 
purpose for which it was disclosed. They should also prohibit 
recipients from sharing the information with others. Kentucky's 
prescription drug monitoring program incorporates these protections.

Integrity

    The integrity of data in a prescription drug monitoring program is 
vital. Programs should be required to verify the accuracy of reported 
information. They should be required to either destroy old data or 
convert it to an anonymous form.

Security Standards

    Maintaining a system of linked electronic databases with 
identifiable prescription drug information poses significant security 
risks. The information is sensitive and can potentially be improperly 
used against individuals. Because the information is identifiable and 
available in a concentrated format, it may also prove to be a tempting 
target both for hackers and for authorized personnel who may have 
improper motives to access the data. The information is a potential 
treasure trove for bitter ex-spouses, potential employers, and others.
    Similar data has been compromised in the past. In the mid 1990's, a 
Florida Department of Health employee downloaded the names of over 
4,000 AIDS cases from a county computer that stored mandatory reporting 
information on new AIDS cases and used the information for ``dating'' 
purposes. The names were also transmitted to two newspapers.\6\
---------------------------------------------------------------------------
    \6\ Robert Trigaux, AIDS List is Out, St Petersburg Times 1A (Sept. 
20, 1996); Editorial: Protect HIV Patients, Miami Herald Sec. L; page 2 
(Oct. 13, 1996).
---------------------------------------------------------------------------
    Security measures can help prevent such loss and the unauthorized 
access, destruction, use, or disclosure of the data. Managerial 
measures include internal organizational measures that limit access to 
data and ensure that individuals with access utilize data for only 
authorized purposes. Such security standards should include role-based 
access and procedures for verifying that those outside the organization 
who request information have the authority to access the information. 
These measures should also include periodic audits to ensure that data 
is being accessed appropriately. Minimum standards should also be set 
for the technical protection of this sensitive data, including storing 
data on secure servers and encrypting information in transmission.
    Serious consideration should be given to the manner in which 
information is collected and maintained in these programs. As discussed 
above, central data bases with names, addresses and prescription drug 
information are tempting targets for security breaches. Furthermore, 
the very idea of centralized data bases elicits strong reaction among 
many individuals. In the recent debate over whether Florida would 
establish a central data base for prescription drug monitoring, Rep. 
Rene Garcia (R- Hialeah) an opponent of the program stated, ``My 
parents fled a Communist country because everything was being 
centralized.'' \7\
---------------------------------------------------------------------------
    \7\ David Royse, Florida Legislature: State Would Keep List of 
Controlled Substance Users Under Bill-(AP) (April 15, 2004) available 
at www.naplesnews.com/npdn/florida/article/0,2071,NPDN	14910	
2809288,00.html.
---------------------------------------------------------------------------
    Some networks that share health information utilize other methods 
for linking their data. For example, the New England Health Electronic 
Data Interchange Network is well-known for its network which does not 
rely on a central database. Federal strategies to encourage the sharing 
of data between prescription drug monitoring programs should consider 
these alternative methods of exchanging data to decrease security 
risks.

Access by Law Enforcement

    Prescription drug monitoring programs should not permit all law 
enforcement agencies unfettered access to collected data. Unfettered 
law enforcement access raises concerns from consumers and physicians 
that they will be improperly targeted for prosecution.\8\ Access should 
be limited to agencies acting within their official duties that are 
conducting bona fide criminal investigations or criminal prosecutions. 
Law enforcement requests to inspect prescription drug monitoring 
program data generally should be subject to review and approval by 
appropriate authorities prior to disclosure. In Massachusetts, for 
example, law enforcement agencies must first direct their request for 
prescription drug monitoring program information to the Office for the 
Attorney General or the Massachusetts State Police Diversion 
Investigation Unit or the U.S. Drug Enforcement Administration for 
notification and approval.\9\
---------------------------------------------------------------------------
    \8\ See GAO, Prescription Drugs: State Monitoring Programs at 18.
    \9\ 105 CMR 700.006.
---------------------------------------------------------------------------

Access by Researchers

    Some prescription drug monitoring programs make their data 
available for research or education purposes. To the extent that this 
information is made available, it should be furnished only in de-
identified form.

Enforcement

    Privacy protections can only be effective if there is real 
enforcement. State laws vary greatly in enforcement or penalty 
provisions. Some appear to provide only for minimal fines such as 
$500.\10\
---------------------------------------------------------------------------
    \10\ See e.g., R.I. Gen. Laws 21-28-4.09.
---------------------------------------------------------------------------
    To ensure compliance with privacy standards, punishment should be 
public and severe.\11\
---------------------------------------------------------------------------
    \11\ See Laurence M. Welsh, Pink Slips Motivate Security 
Compliance, searchsecurity.com (March 29, 2004) available at http://
searchsecurity.techtarget.com/originalContent/0,289142,sid14	
gci957013,00.html.
---------------------------------------------------------------------------
    Federal standards should provide for significant civil and criminal 
penalties for:
     Authorized personnel improperly obtaining, using or 
disclosing information from a prescription drug monitoring program.
     Recipient's improperly using or disclosing information 
that they obtained from a prescription drug monitoring program.
     Any person's improperly obtaining or using prescription 
drug monitoring program information.
    States should, of course, remain free to provide for private rights 
of action.

III. Conclusion

    Prescription drug monitoring programs appear to be an effective 
tool in reducing prescription drug diversion and abuse. Minimum privacy 
standards should be an essential component in any Federal programs to 
encourage the expansion and interconnectivity of these programs.

    Senator Sessions. Congressman Whitfield, great to see you. 
I know you are having votes over at the House. We have heard 
from all the panelists now. We would be delighted if you would 
like to make your statement now, and maybe Ms. Pritts could 
move over, and just pull your chair up. We thank you for your 
leadership on this effort and for the progress that the 
legislation seems to be making in the House.

 STATEMENT OF WHITFIELD, HON. ED, A REPRESENTATIVE IN CONGRESS 
                   FROM THE STATE OF KENTUCKY

    Congressman Whitfield. Mr. Chairman, thank you very much. I 
am quite excited about being here. I genuinely appreciate your 
holding this hearing, and I certainly want to thank Ms. Pritts 
for giving me her seat this afternoon.
    [Laughter.]
    Mr. Chairman, you are exactly right. This issue of 
prescription drug monitoring plans is a vitally important issue 
to our Nation. I think prescription drug abuse is a national 
issue and, as a matter of public health, one that Congress must 
address.
    When we talk about prescription drug abuse, we are talking 
about individuals using controlled substances in a manner that 
is inconsistent with their prescribed use. Many people, all of 
us know, live with chronic pain or have pain as a direct result 
of a disease or injury. And in many cases, relief from that 
pain comes only from a controlled substance. Unfortunately, 
many people who are prescribed controlled substances to relieve 
pain, either on a long- or short-term basis, become addicted to 
them. The issue becomes how do we help prevent that abuse. And 
while there are a myriad of factors that contribute to the 
abuse of controlled substances, one important way we can combat 
this problem is encouraging State prescription drug monitoring 
programs.
    Many States, as we have heard testified this afternoon, 
including my own State of Kentucky, have these monitoring 
programs, and I am not going to discuss the KASPER program 
because I know that Secretary Holsinger from Kentucky has 
already discussed our program. We think it is quite a 
successful program.
    While KASPER has been effective in Kentucky, there is an 
inherent flaw in State prescription drug monitoring programs. 
They are only effective intrastate. Kentucky is bordered by 
seven States, and most of them do not have their own drug 
monitoring programs. For example, in my congressional district, 
we have 12 counties bordering with Tennessee, and Tennessee 
does not have a monitoring program. Therefore, a physician in 
Kentucky may receive a KASPER report indicating that the 
patient has never been prescribed a controlled substance in 
Kentucky, but they certainly do not have the access to what was 
prescribed next door in Tennessee. And that is one of the fatal 
flaws in our existing system.
    In fact, the January 2004 Journal of the Kentucky Medical 
Association concluded an article on KASPER stating that the 
major problem with prescription drug information is that this 
information is not available nationwide, and prescriptions 
filled in out-of-State pharmacies to the KASPER system.
    So I believe very strongly, Mr. Chairman, that the best way 
to address this issue is by requiring all States to establish 
prescription drug monitoring programs. And I have been working 
with my colleagues, Congressman Charlie Norwood of Georgia and 
Congressman Frank Pallone of New Jersey, on legislation 
mandating that all States enact a prescription drug monitoring 
program. And I am happy to say that this is one of those issues 
on which there is broad bipartisan support on the House side, 
and our bill, the National All Schedules Prescription 
Electronic Reporting Act, called NASPER, establishes a grant 
program housed at the Department of Health and Human Services 
which provides States with funding to establish and operate 
these programs. Our current draft requires States to cover 
Schedule II through IV controlled substances, allows 
practitioners and law enforcement officials access to the 
information, and, most important, provide for interstate 
operability. And, of course, we are quite cognizant of the 
importance of privacy and are still addressing that issue, have 
not resolved it completely at this time. But we did have a 
hearing on this, Mr. Chairman, and I specifically asked 
Secretary Tommy Thompson about creating such a program when he 
testified before the House Energy and Commerce Committee last 
spring, and he indicated that he supported a prescription drug 
monitoring program and specifically that he would support it 
housed at HHS.
    With that, that concludes my testimony, Mr. Chairman. Once 
again, I want to thank you for your leadership, for your 
working with us, and I look forward to our continued 
cooperation as we try to solve this problem.
    Senator Sessions. Well, thank you for that excellent 
statement and summary of the situation.
    Let me ask you, Congressman Whitfield, are you finding 
growing support for this in the House? I know it is always 
dangerous to predict anything, but do you feel pretty good 
about how the House is considering this legislation now?
    Congressman Whitfield. Well, I do, Mr. Chairman. We have 
worked very closely on both sides of the aisle in the Energy 
and Commerce Committee with staff and with members, and things 
are really coming together right now. Right now we have a 
hearing scheduled--not a hearing, we actually have a markup 
scheduled next Thursday with the full committee, and we 
expect--recognizing what you said that you can never state with 
100-percent certainty, but we feel that the bill will be 
reported out of our committee at the end of next week.
    Senator Sessions. I think that is a compliment to you and 
the leadership that you have given to it, and maybe to the 
merits of the issue. The growing States that are doing it, more 
and more States are undertaking this, is a good indication 
something is working, don't you think?
    Congressman Whitfield. Absolutely, and it is my 
understanding that the total number of States that either have 
a program or are working to establish programs right now is 
somewhere in the neighborhood of 31. So there is momentum out 
there. There is certainly a need. And as I said, I look forward 
to working with you and other Members of the Senate to help 
address this problem.
    Senator Sessions. Well, thank you. I would be delighted for 
you to stay. You can join me here or stay there, and I have 
some questions for the other members of the panel, too. And if 
you have any final comments, we would welcome them.
    Congressman Whitfield. Well, thank you very much, Mr. 
Chairman. I would like to stay and hear a few questions and 
answers, and then I am going to leave. We have a product in 
Kentucky called tobacco, and we have a little hearing on that 
at 3 o'clock, and so I need to get over there for that. I know 
this is a health hearing, but this relates to farmers. So thank 
you.
    Senator Sessions. I understand. Very good.
    [The prepared statement of Congressman Whitfield follows:]

             Prepared Statement Of Congressman Ed Whitfield

    Thank you Mr. Chairman for the opportunity to testify 
before the committee on an issue that is very important. 
Prescription drug abuse is a national issue and, as a matter of 
public health, one Congress needs to address. President Bush 
has made a commitment to curbing prescription drug abuse 
through the Office of National Drug Control Policy and I know 
we will make every effort to work with him on this issue.
    When we talk about prescription drug abuse, we're 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 classified drugs 
into five schedules based mostly on their potential for abuse. 
Although Schedule I drugs, such as heroin, are not legally 
available, Schedule II through V 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 in 
many cases relief from their pain comes only from a controlled 
substance. It is important that those individuals continue to 
have access to such drugs. Unfortunately, some people who are 
prescribed controlled substances 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.
    We are all familiar with the problem of prescription drug 
abuse and the millions of Americans who use these drugs for 
non-medical purposes. The issue becomes, how do we help prevent 
the abuse? While there are certainly a myriad of factors that 
contribute to the abuse of controlled substances, I believe one 
important way we can combat this problem is through enhancing 
State prescription drug monitoring programs (PDMPs).
    Many States, including my own State of Kentucky, have 
PDMPs. Our system, known as the Kentucky All Schedules 
Prescription Electronic Reporting (KASPER) program, is 
effective. I know Secretary Holsinger will discuss KASPER in 
greater detail, but to summarize, KASPER requires all 
prescription drug dispensers in Kentucky to electronically 
report information on Schedule II through V controlled 
substances to a database operated by the State. The database 
contains information on individuals who have been prescribed 
any of those scheduled drugs, including the prescribing 
physician, and the pharmacy where the prescription was filled.
    In addition, law enforcement authorities have access to the 
database under certain circumstances. This partnership of 
physicians and law enforcement strikes the right balance of 
treating those who have addiction problems and prosecuting 
those who are breaking the law.
    Physicians in Kentucky use KASPER to obtain information on 
their patients to determine if they have previously been 
prescribed one of these scheduled drugs. This is an invaluable 
tool for doctors in determining the best treatment for their 
patients. If by using KASPER a doctor discovers that a patient 
complaining of pain was recently prescribed OxyContin by 
another physician, and the patient failed to disclose that, it 
gives the doctor an indication that their patient may have an 
addiction problem.
    While KASPER has been effective in Kentucky, there is an 
inherent flaw in State prescription drug monitoring programs: 
they are only effective intrastate. Kentucky is bordered by 
seven States and (Tennessee, Missouri, Illinois, Indiana, Ohio, 
West Virginia, and Virginia) most do not have their own drug 
monitoring systems. For example, I have 12 counties that share 
the border with Tennessee.
    Tennessee does not have a PDMP. Therefore, a physician in 
Kentucky may receive a KASPER report indicating that their 
patient has never been prescribed a controlled substance in 
Kentucky, but has no way of knowing if that individual has 
received and filled a prescription in Tennessee.
    Because individuals seeking to obtain fraudulent 
prescriptions for controlled substances is a national problem, 
I believe drug monitoring programs must also be national. A 
physician in Kentucky, or any other State, should be able to 
receive a report on a patient that will tell them not only if 
that patient was prescribed a controlled substance in their own 
State, but in any State. The January 2004 Journal of the 
Kentucky Medical Association concluded in an article on KASPER 
``Another problem with prescription drug information is that 
this information is not available nationwide. Prescriptions 
filled in out-of-State pharmacies are not reported to the 
KASPER system. Patients who tend to abuse prescription drugs 
may be fully aware of the limitations of the KASPER system and 
seek to fill prescriptions outside the Commonwealth.''
    I believe the best way to address this issue is by 
requiring all States to establish prescription drug monitoring 
programs. I have been working with my colleagues, Congressman 
Charlie Norwood and Congressman Frank Pallone, on legislation 
mandating all States enact a PDMP. Our bill, the National All 
Schedules Prescription Electronic Reporting (NASPER) Act 
establishes a grant program housed at the Department of Health 
and Human Services which provides States with funding to 
establish and operate PDMPs. Our current draft requires States 
to cover schedule II-IV controlled substances, allow 
practitioners and law enforcement officials access to the 
information, and most important, provide for interstate 
operability. I asked Secretary Tommy Thompson about creating 
such a program when he testified before the House Energy and 
Commerce Committee last spring and he indicated his support for 
a national PDMP housed at HHS.
    This is a delicate issue as it involves physician 
prescribing practices and we must be certain that our efforts 
are targeted at preventing the abuse while ensuring that all 
Americans suffering from pain continue to have access to needed 
medications. The last thing we want to do is scare doctors and 
patients and create a situation where physicians are under 
treating pain for fear of being arrested and patients are under 
reporting pain out of the same fear. Existing PDMPs operate on 
that principle by involving all stake holders such as State 
medical and pharmacy boards, law enforcement, and public health 
officials. I believe a system focusing on only one side of the 
equation is not beneficial and yields no long term benefits. 
Prevention is the goal and we must keep in mind that doctors 
are the main source of these drugs. Above all else, our efforts 
should be focused on preserving the integrity of the doctor-
patient relationship.
    The Federal Government has a clearly established role in 
this area, and any efforts to further enhance the monitoring 
and distribution of controlled substances should have a Federal 
component. NASPER would be an invaluable tool, especially for 
physicians, in our efforts to prevent prescription drug abuse.
    Senator Sessions. Dr. Holsinger, let me ask you just a few 
questions first. Kentucky, as I understand it, thought you had 
a fairly serious problem with prescription drug abuse before 
this program was initiated, and if that is true, do you feel 
that there has been any reduction in the size or scope of that 
problem as a result of your program?
    Dr. Holsinger. Well, I think that we have been able to see 
certainly a heightened awareness of the issue, and I think that 
we probably have been able to see a reduction. It is hard to 
quantify because the drug of choice tends to change depending 
on the enforcement around any one particular pharmaceutical 
agent. So it appears that in Kentucky, where OxyContin was the 
major drug of choice for abuse, that is now slipping and it 
looks like it is going to slide into second or third place. So 
the problem is that as you maintain control in one sphere, it 
is very easy for another drug to become the drug of choice.
    Senator Sessions. I remember being active in an effort to 
deal with the prescription drug problem in Mobile when I was a 
prosecutor, and, in fact, we made tremendous progress. Talwin 
mixed with another drug was as addictive almost as heroin, and 
we virtually eliminated that. That was sort of a remarkable 
achievement to me. It made me come to believe that this is a 
winnable war. It is hard to stop marijuana and cocaine that 
comes in under the table from every area around the world and 
just filters through. But prescription drugs come through 
pharmacies, through doctor prescriptions. It is not that easy, 
and we have laws in place that were designed to stop the abuse.
    We are really not altering, as I understand it, Ms. Green, 
any of the fundamental principles that we have already had. We 
are just updating them with technology so they more effectively 
work to stop the problem. Would you agree with that?
    Ms. Green. I would, Senator. One of the things we stress is 
that this is a particular database mechanism. It is a way of 
expediting the collection and analysis of the information 
precisely so the system can be used as a means of early 
identification.
    So the system itself does not actually change any 
particular rules, laws, or regulations, that exist in a State. 
It simply expedites the ability of all the officials in the 
State and prescribers to be able to identify as early as 
possible a problem and then address it as early as possible.
    Senator Sessions. We do not need to be prosecuting people 
if we can avoid it. There is a certain small number of just 
utterly unscrupulous people that know how to forge 
prescriptions or get drugs and sell them for a nice profit, as 
Dr. Varley indicated. But there are a number of people who 
become addicted and get driven to have that drug again and 
again and again. And they lie to physicians. They go around to 
multiple physicians. And that is, I think, Dr. Varley, 
something that you mentioned.
    Let me ask you, Dr. Holsinger said at first physicians were 
somewhat skeptical of this program in Kentucky. I know in other 
times in the Senate we have had pain physicians express some 
concern about regulation because they were afraid it would keep 
them from perhaps prescribing drugs to people who needed pain 
relief. But your national group represents over half the pain 
physicians in America who actually--these are the people 
prescribing these painkillers on a regular basis. You strongly 
support this legislation. In fact, you are pushing it. Do you 
think that physicians nationwide are coming around to seeing 
the value of this kind of control?
    Dr. Varley. Yes, I believe that this is an important part 
of providing excellent care to our patients. We have to be able 
to differentiate between the legitimate and the illegitimate 
patients. And we can try to do this with our history-taking 
skills or doing due diligence in determining that there is an 
accurate diagnosis, that the patient is actually exhibiting 
pain behaviors. That is all a part of the practice of medicine.
    However, we have no way of knowing whether that patient 
goes to another doctor across the street or across the State 
line to get other types of medications. So I think that this 
will enable us to practice a higher quality of medicine to make 
sure that patients who need specific drugs, whether they are 
narcotics or other psychological medications, and not have to 
worry that we are going to be putting that patient at risk 
because of multiple medications or putting our children at risk 
because the drugs are being sold in the schoolyard.
    So I think that the physicians that I know, the bona fide 
pain physicians who are working for the best interests of our 
patients, strongly support this type of legislation.
    Dr. Holsinger. Senator, I think it is fair to say that in 
Kentucky, physicians today are very accepting of this and 
recognize it as a major tool, as Dr. Varley has said, in their 
practice in order to provide quality care to their patients. 
And I think that is one of the key reasons why 85 percent of 
the requests to date have come from physicians. They see the 
usefulness of this information in the care of their patients, 
and I think that is a real plus as we move forward into the 
future.
    Senator Sessions. So 85 percent of the inquiries to 
determine whether or not someone has multiple prescriptions 
come from physicians who are concerned about their patients. Is 
that basically it?
    Dr. Holsinger. That is correct. It is interesting, in our 
situation only 4 percent come from pharmacists, but the 
pharmacists are a key part of this; 8 percent from law 
enforcement; 2 percent from the licensure board. We have had 
none by court order or subpoena at this point in time, so it 
has been a very effective tool for physicians.
    Senator Sessions. Well, I think that does go to the point 
that this is a patient treatment issue, a physician-patient 
treatment issue. In other words, Dr. Varley, I have heard 
physicians tell me, I have heard pharmacists tell me, I have 
heard dentists tell me that people come by and they can pretty 
well spot them, and they are script-getters. They come in and 
complain about pain, and they are dubious immediately about it. 
Some tell me, ``I just will not do it. If I have an uneasy 
feeling, I will not write it.'' But that is pretty embarrassing 
for a physician, is it not, a little bit difficult for the 
physician who has no real proof of the problem? Does this give 
a physician better information to make a better decision if he 
has some doubt about the patient that is asking for pain 
relief?
    Dr. Varley. I think--and I brought up in my presentation--
that the timeliness of this information----
    Senator Sessions. You did. You used ``real time.'' And what 
do you mean by that?
    Dr. Varley [continuing]. Real time so that if a patient is 
in your office, that within the time, the 20 or 30 minutes that 
the patient is physically present in your office, that you can 
get useful information back. What we are currently doing is 
routine or random urine drug screens, and what I not uncommonly 
have to do, unfortunately, is when I find a patient who does 
not have the drug in their urine that I am prescribing, it 
generally means that they are either giving it to somebody or 
they are selling it on the street. So that is currently--and 
that is a reactive way of doing it. In other words, I already 
prescribed the medication. They are already diverting it on the 
street. And then I find out that this is going on.
    So if I have a tool that will enable me to preemptively not 
write that prescription, then it is better for the patient, 
better for the people that would be exposed to that drug.
    Senator Sessions. And if you saw a large number of 
prescriptions that that patient had obtained and you knew that 
they were abusing the prescription drug, would you refer them 
for treatment? Would you counsel them?
    Dr. Varley. I would definitely counsel the patient. We have 
some patients who openly admit that they have a problem. In my 
practice, I have a psychologist who works with me, and when we 
identify patients with those problems, we try to direct them 
either to a psychologist or an addiction specialist to try to 
get them help with their problem.
    Senator Sessions. Dr. Varley, the--well, I had a very good 
question. It got out of my mind, and I will go to the next one 
to Ms. Green. You said there was a study that was being 
undertaken now that may give us some good information about how 
effective this is. Would it give us any information about any 
cost savings in terms of Medicaid and Medicare or private 
insurance carriers?
    Ms. Green. That is correct, Senator. The National Institute 
of Justice has contracted with a company to actually design an 
evaluation which could then be applied to the existing State 
programs to actually determine the cost-effectiveness and the 
costs and benefits looking at indicators such as Medicaid fraud 
costs, decreases in Medicaid fraud, even insurance fraud, what 
has happened to that, decrease in investigation time, to 
determine the true effectiveness of the programs, and also to 
use the information as a way to constantly improve the 
effectiveness of the programs.
    Senator Sessions. I am a big believer that the National 
Institute of Justice should help in these areas, and I will 
look forward to supporting their efforts, because one of the 
best things the National Institute of Justice and the 
Department of Justice can do to deal with drug and crime 
problems in America is provide good research information to the 
States. The States can oftentimes devise their own programs, 
but they are not often able to spend the money to do a major 
study. So I am glad to see that is being done. Do you have any 
idea when it might be completed?
    Ms. Green. I know that the evaluation design itself is 
supposed to be completed by the end of the year. After that, 
they will then begin the evaluation process, which to my 
understanding this could occur anywhere over the next 9 to 12 
months. But that has not been decided definitively yet.
    Senator Sessions. Ms. Pritts, the question of a database a 
legitimate one. If it is easy for a physician to get 
information or if it is easy for law enforcement or a 
pharmacist, or the licensure board to get information, it could 
also be easier to disseminate that information.
    First, let me ask Ms. Green and Dr. Holsinger, are you 
aware of any abuses of systems that you are aware of around the 
country or in your State?
    Dr. Holsinger. We are not in Kentucky, Senator. We have, we 
think, pretty stringent sanctions on the inappropriate or 
illegal use of this kind of information. As I said, to use it 
illegally is a Class D felony. That is 1 to 5 years in prison. 
It is a real effort to make sure that we do use it only 
appropriately. And we have chosen to build into our system the 
HIPAA privacy pieces to it in an effort to be able to make sure 
that we are making at least--having a system that is HIPAA-
compliant.
    Senator Sessions. And that had not made--has there been any 
problem in the operation of the system?
    Dr. Holsinger. It has not at this point in time. We have 
one outstanding issue, as we are finalizing the development of 
our electronic system, that will take us to 15-minute 
turnaround time for physicians. And we are waiting for an 
opinion from our general counsel's office as to whether or not 
we have to treat law enforcement as a business partner under 
HIPAA regulations. If we have to treat them as a business 
partner under HIPAA regulations as we apply them in this 
system, that will cause some constraints on our law enforcement 
efforts, I think. But we do not have an answer to that question 
at this time yet.
    Ms. Green. Senator, none of the existing operating 
programs, including those that have been operating since 1939, 
have had any successful claims based on inappropriate 
disclosure of information or inappropriate use of the 
information by the operating system.
    Senator Sessions. Now, Ms. Pritts, right now pharmacists, 
and, overwhelmingly, most pharmacists, have a computerized 
system, bar code, or whatever that clocks in the--I guess they 
clock in and inventory their drugs when they come in, and they 
are inventoried as they go out at the checkout counter or the 
cash register. That is available to, I guess, abuse of anybody 
who has access to that system in that pharmacy. This would 
create access to all of that information at one central State 
source that could be accessed by doctors throughout the State.
    So my understanding is that your concern is it would be 
easier for a person to explore the system if they could 
penetrate that if you have a statewide system. Is that your 
concern?
    Ms. Pritts. Well, it is the size--there are a number of 
issues here. One is the size of the database. As you include 
more people, it becomes more tempting for people to hack into. 
Information is very valuable, especially in today's economy. 
And there was a recent situation up in Canada where somebody 
stole a Canadian online pharmacy, their database, and then they 
tried to sell it to people at a profit.
    So, similarly, when you have a lot of information in one 
place, particularly if it is information that people might be 
embarrassed about or would prefer not to have made public, it 
becomes almost like candy in a candy store for some people who 
would like to either hack into that information just for fun or 
because there is somebody that they might have a vendetta 
against and they think it might be in there, people who are 
just on fishing expeditions, too. So the bigger it is, kind of 
the more attractive it can be.
    Dr. Holsinger was talking about the privacy protections 
they have in place in Kentucky, which sound like they are quite 
stringent, and there are a number of other States that also 
have those types of protections. And it would be good if 
everybody had the same level of protection.
    We had the same situation just with regular medical 
information prior to HIPAA. There was a lot of it that was in 
paper format. People recognized as you move it into an 
electronic format, you are dealing with a different kind of 
animal. If you want a copy of the data, you don't have to xerox 
thousands of pieces of little prescription pads. You just hit a 
mouse button, and you have it.
    Senator Sessions. It is very, very difficult in a State 
system that is not automated to get information. For example, 
cases I have seen and investigated, investigators may have to 
go find paper records at Pharmacy A and go around and check 
virtually every pharmacy in town because they do not know which 
one the abuser used. So it is almost--that is one reason it is 
so intimidating, that very seldom do we do that, so you have 
got to balance the danger of a concentrated thing to have some 
privacy dangers there against basically the workability of the 
entire system that we have created. Would you agree that is 
what we are wrestling with?
    Ms. Pritts. I do agree that balancing is a very difficult 
act, and there are systems in place where they do this quite 
effectively on a fairly real-time basis with doctors where they 
do not use a central database. And I think those are at least 
worth investigating as an alternative.
    People are very--the American public is--there is a big 
section of the American public that is very concerned about the 
development, the continued development of these large databases 
with a lot of identifiable information in them. There are a 
number of people who see the black helicopters circling every 
time you mention government, the government getting involved in 
this, and particularly with the Federal Government getting 
involved in it. I think that those present real road blocks.
    Senator Sessions. I do not think there is any doubt that 
people are worried. I will say this, though. I do not find a 
lot of people coming up to me that say on the HIPAA or other 
regulations that this hospital violated my privacy or this 
insurance--in theory, they are concerned about the possibility, 
but I am not seeing a great uproar to me about specific 
instances of privacy violation.
    Dr. Varley, you said something interesting that you often--
or how often do you prescribe a urine test on your patients? 
And why do you do that?
    Dr. Varley. I feel like I am Detective Colombo sometimes. 
We have suspicions. Part of it comes from the assessment of the 
patient when they come in. What are their subjective 
complaints? How severe and where is there pain? Does it make 
physiologic sense? When we do a physical examination, does it 
correlate with their complaints? And then there is that 
unwritten, unspoken feeling that you sometimes get, you know, 
you are suspicious.
    We do both routine and random drug screens on patients. 
Certainly the drug of choice, as I said in my presentation, 
appears to have been OxyContin, but other drugs--certainly 
Dilaudid was mentioned and hydrocodone and methadone. All of 
those drugs have the potential for abuse.
    So I basically do the urine screens as part of what I 
consider the good practice of medicine to identify those 
patients who are abusing my services and the health care system 
and diverting the medications.
    Senator Sessions. What do you find when you do the--what is 
a concern? What do you often find when you do one of those 
screens?
    Dr. Varley. Being an Attorney General in the past, you 
probably realize how can you tell when a drug addict is lying? 
Their lips are moving. They will deny--you know, you show them 
the--I show them the report. I do not tell them. I show them 
the report. And they will deny, and they will come up with all 
sorts of different explanations for why the drug is not in 
their urine. And I have seen probably most of the stories or 
heard most of the stories about why it is not in there.
    Senator Sessions. But that helps you--you do not call the 
police and say come arrest them at that point?
    Dr. Varley. Personally, I feel that would be a conflict of 
interest in my physician-patient relationship.
    Senator Sessions. Your goal is to try to stop the bad 
behavior and help your patient. Is that correct?
    Dr. Varley. No, in my narcotics agreement that I have with 
my patients, they give me the right, once I prescribe 
medications, that should a law enforcement officer come and ask 
to see their medication records--now that does not mean that 
they get access to the full medical record but just their 
medication records--then they give me the right to give that 
information to that law enforcement officer. So we provide that 
information if they are under investigation from probable cause 
out in the community.
    Senator Sessions. And the association, ASIPP, that you 
belong to believes that in your experience of dealing on a 
daily basis with people suffering from pain and understanding 
and seeing the reality of the addiction problem in America, 
that this kind of system that they are doing in Kentucky and 
other States is humane and beneficial and helpful in treating 
people and helping people to avoid addiction problems.
    Dr. Varley. I think that there may be three different types 
of patients that we are dealing with here: Patients who have 
legitimate pain conditions that are being appropriately 
treated, let's not try to discourage physicians from 
appropriately treating those. We have other patients who have 
an addiction problem; their problem is not pain, their problem 
is addiction. So to practice good medicine we have to get them 
into a program that will address their addiction. And then 
there is a third group and, quite frankly, they are outright 
criminals. They are obtaining drugs fraudulently and making a 
buck off of other people's misery.
    Senator Sessions. Well, they do need to be reported to the 
police. I think you are correct.
    You mentioned young people. After I ceased being a 
prosecutor, not long before I became a Senator, I got asked to 
represent a young man who had been president of his high school 
senior class, had been injured in sports and had knee pain, and 
was getting scripts passed all over town, and it said one 
refill, he would raise it to seven, and things like that. It 
was really sad, very sad.
    Do you think that young people might be reluctant to try 
cocaine or heroin, but be less afraid of prescription drugs and 
get in trouble with them more than we would suspect?
    Dr. Varley. I think that there is a tendency to that. I 
think it is a matter of availability, it is a matter of 
education, and maybe physicians, we should take a more active 
role in our school system to educate our young people about the 
dangers. And, unfortunately, I have a report similar to the one 
you told us here 2 weeks ago. I was talking to my wife just 
before we came into the committee, and she called to tell us 
that an acquaintance of one of my other daughters, who is 
attending Auburn University, died of a methadone overdose. And 
that is something that just happened yesterday. And so, I mean, 
this is a real problem. It is affecting people in all avenues 
of society, and particularly--this young person had a future 
ahead of them. They would have been very productive. And, 
unfortunately, they got caught up in this illicit prescription 
drug use and died in the process.
    So I think we do have to educate. We have to decrease the 
demand for these drugs as well as to decrease the availability 
of them.
    Senator Sessions. Would any of you have anything further to 
add? Dr. Holsinger?
    Dr. Holsinger. Thank you, Senator. I was just going to add 
that an individual who ends up abusing prescription drugs has 
to start some time. They do not start at a full-fledged abuse 
situation. A system like ours, electronically operated with 15-
minute turnaround time for a physician, in other words, real 
time, an opportunity to know what is going on, I believe will 
give us the opportunity to have early intervention as well and 
be able to identify individuals who are initially starting the 
types of behavior that indicate that they are abusing these 
kinds of substances and, therefore, have an opportunity for 
much earlier intervention than having to deal with the backlog 
of individuals that we are identifying now that have had 
longstanding issues.
    Senator Sessions. Well, that is exactly my thinking, 
because we need to stop this before they become seriously 
addicted. You know, you can get habituated to a drug, but if 
you can find it early enough, perhaps they are not as addicted 
and it is so hard to quit. I dealt with a witness in a case, 
and he just could not stop--could not--I mean, he would go into 
a frenzy to have another fix of drugs. And, also, they can get 
arrested. Also, if they are not stopped early, then they have 
to go through a long and expensive treatment program. Families 
can break up. People can lose their jobs. They can abuse their 
spouses. Children get abused with people who are addicted to 
drugs. Or they use their money up. They become financially 
unable to pay their bills and take care of their families.
    So I think that there is a human need out there that is 
very significant. It strikes me that since we are keeping all 
these records anyway, everybody has to keep them--the 
pharmacist, the doctor--and DEA and other places can review 
them and all of that. We might as well keep them in a way that 
the physician can have access to them and maybe intervene and 
stop this kind of problem in the future.
    Any other comments? Ms. Green?
    Ms. Green. Yes, Senator. I would just like to build on the 
conversation by suggesting that in order for a PMP to be as 
effective as possible in intervening at an earlier stage of 
someone's addiction, States will need to be willing to dedicate 
sufficient treatment resources so that once these people are 
identified as needing treatment, there is somewhere to send 
them, meaning an appropriate treatment program.
    Senator Sessions. I tend to agree with that. There are a 
lot of avenues to deal with addiction absent long-term, highly 
expensive institutional treatment. We are trying to get some 
studies done by the National Institute of Justice on some of 
those programs, how well they work and what is the best to 
spend limited resources on. But obviously the best thing is not 
to be addicted to begin with, stop it to begin with.
    Anything else?
    [No response.]
    Senator Sessions. Thank you for your comments and your 
remarks. One thing, if we do have sufficient funding, Ms. 
Pritts, perhaps we will be better able to meet some of the 
ideas and suggestions you have to make the system better. I 
think a number of the suggestions you made on privacy issues 
could be adopted with not a lot of expense and might be very 
practical as the State goes forward. So we thank you for 
sharing that with us.
    We will leave the record open. I know Senator Dodd had 
requested to be able to submit a statement. We will keep the 
record open until close of business tomorrow.
    [The prepared statement of Senator Dodd follows:]

           Prepared Statement of Senator Christopher J. Dodd

    Mr. Chairman, I want to thank you for holding a hearing on 
the issue of abuse and diversion of prescription drugs. I am 
hopeful that this hearing will shed some light on the severity 
of this problem in our country and provide a forum for 
discussion about solutions to the problem, including the 
establishment of a Federal Prescription Monitoring Program 
(PMP).
    More than six million Americans use prescription drugs for 
non-medical purposes. The majority of prescription drug abuse 
occurs with pain relievers. While these drugs are absolutely 
critical for the millions of Americans suffering from chronic 
pain, if used improperly they can lead to addiction.
    The potential for abuse of these drugs presents a serious 
challenge. We certainly do not want to prevent physicians from 
prescribing them to patients. Access to pain relief improves 
the quality of life for millions of Americans, many suffering 
from serious and debilitating illnesses. At the same time, 
abuse and diversion of these drugs ruins lives, destroys 
families, and results in thousands of deaths each year. 
Prescription drug abuse is also becoming a disturbing trend 
among youth. Among 18-25 year olds, only marijuana is abused 
more frequently. Just over a week ago, an 18-year-old in New 
Fairfield, Connecticut died after overdosing on a prescription 
pain medication.
    Much of the testimony at today's hearing will focus on the 
use of PMPs to reduce prescription drug abuse. It is my belief 
that monitoring programs have the potential to be an enormously 
valuable tool in our fight to reduce prescription drug abuse, 
and I applaud this committee for taking a close look at this 
approach.
    At the same time, any successful program to combat 
prescription drug abuse must keep the following principles in 
mind. First, it is critical that the confidentiality and 
privacy of patients are protected. We must not create a system 
where PMPs are used to target patients for prosecution. Those 
suffering from chronic pain should know that they can seek 
relief from their suffering without jeopardizing their right to 
privacy. Along the same lines, we must ensure that physicians 
can continue to appropriately prescribe these medications 
without undue fear that they will run afoul of law enforcement. 
PMPs should be used to help physicians identify patients in 
need of help and direct them to the appropriate services.
    We also must make sure that the information in PMPs is used 
appropriately. Of course, we must continue to support law 
enforcement efforts to fight prescription drug abuse. Where 
laws are being broken and drugs are being diverted by dealers 
for sale on the streets, we should provide law enforcement with 
the tools necessary to prosecute criminals. However, we must do 
so in a way that respects the civil liberties that are the 
cornerstone of our democracy. While PMPs can be helpful in 
bringing criminals to justice, access to this sensitive 
information must be carefully controlled lest it is abused.
    Once again Mr. Chairman, I appreciate your willingness to 
shed light on this important issue, and I thank all of the 
witnesses for being here today. I look forward to working with 
my colleagues to address prescription drug abuse and diversion, 
while ensuring that patients can continue to benefit from 
necessary medications without risking their privacy.
    Senator Sessions. If there are no other comments, we will 
be adjourned, and thank you so much for your excellent 
testimony.
    [Additional material follows.]

                          ADDITIONAL MATERIAL

                     Statement Of David Kloth, M.D.
    It is my pleasure to present the committee information on what has 
become an extremely serious health problem in the United States. 
Prescription medication substance abuse and diversion has reached 
epidemic proportions in this country. It is affecting many aspects of 
our society, but perhaps most concerning, is the widespread 
availability of these powerful and legal medications to children and 
young adults. Each and every day another young life is claimed from 
drug overdose caused by readily available and seemingly legal 
medications. Millions of American adults are addicted to or 
inappropriately using schedule II, III, and IV controlled substances.
    My name is David Kloth, I am an actively practicing board certified 
pain physician. I am the Executive Vice President of the American 
Society of Interventional Pain Physicians (ASIPP), the President of the 
Connecticut Pain Society, and the Founder, Medical Director and 
President of Connecticut Pain Care. Each and everyday I treat patients 
suffering from a multitude of different pain conditions, often using 
chronic narcotic medications to help control these symptoms. As an 
interventional pain physician, I have many different options available 
to help treat pain. My initial approach and treatment goal is to 
control an individual's pain with targeted (fluoroscopically or X-ray 
guided) injections, thereby treating the pain at its source and 
hopefully eliminating the ``pain generator.'' Even with such treatment, 
many patients still require pain-relieving medications. Unfortunately, 
some patients acquire and/or use prescription medications for non-
medical purposes. Substance abuse may lead to a given patients own 
demise; even worse, when diversion of medications to our streets 
occurs, it can cause tragic consequences to the innocent and unknowing.

                  PRESCRIPTION MEDICATION ABUSE TODAY

    An estimated 4.4 million Americans used prescription pain relieving 
medications for non-medical purposes in 2002. This has resulted in 
hundreds of thousands of emergency room visits each year. The Drug 
Abuse and Warning Network (DAWN), in a November 2003 report, showed a 
210 percent increase in emergency department visits from 1994-2002 for 
psychotherapeutic drugs, including opioids (narcotics) and 
benzodiazapines (sedatives).



    Drug diversion and abuse is associated with increased crime rates 
and has a destructive effect on the family, including our children. 
Neonatal units are seeing increasing numbers of ``Oxy-babies.'' There 
are thousands of fatalities in the United States each year from 
prescription medication overdose. The economic cost to society of 
treating these individuals has been estimated in the billions of 
dollars. The indirect costs through lost productivity, associated 
criminal activity, accidents, rehabilitation, and family destruction 
(to name just a few), is difficult to measure. One study by the Office 
of Management and Budget, estimated costs associated with drug abuse in 
the United States at $300 billion a year, this included the expense of 
government anti-drug programs and the costs of crime, healthcare, 
accidents, and lost productivity.
    During 2002 a questionnaire (from Monitoring the Future Study) 
regarding Oxycontin usage revealed, 1.3 percent of eighth graders, 3.0 
percent of tenth graders, and 4.0 percent of twelfth graders reported 
using Oxycontin for non-medical reasons. In 2003, this increased to 1.7 
percent, 3.6 percent, and 4.5 percent respectively. The problem is 
growing. It is estimated that over 32 million Americans have used pain-
relieving medications for non-medical purposes-lifetime usage (from 
National Survey on Drug Use and Health-HHS). Non-medical use of 
Oxycontin has grown from 1.9 million in 2002 to 2.8 million in 2003, 
and in 2004 will approach 4 million. Oxycontin's potency and its handy 
distribution network--local pharmacies and the internet--have made it 
more insidious and difficult to control than any other drug. A 1997 
Household survey on Drug Abuse revealed that the non-medical use of 
prescription drugs exceeded all illicit substances except for marijuana 
and hashish. In the age group of 18-25 year old the incidence of 
marijuana usage is estimated at 17.3 percent and the non-medical use of 
prescription medicines is 5.4 percent.



                     PRIOR HELP COMMITTEE HEARINGS

    In the past, the Senate HELP Committee has had hearings on 
Oxycontin, prescription drug abuse and diversion. This issue is not new 
to our government. NASPER is a solution to one component of this 
problem, ``doctor shopping.'' NIDA (National Institute on Drug Abuse) 
in prior hearings has informed the committee of the seriousness of this 
problem and has directed significant attention to this problem by 
encouraging research and program development for more effective 
behavioral and pharmacological treatments of this problem. Abuse of 
prescription drugs now ranks third in this country behind only alcohol 
and marijuana.

                    THE LEGITIMATE TREATMENT OF PAIN

    When used properly, as legitimately prescribed by the physician, 
these medications are safe, effective, and medically indicated. 
Controlled prescription drugs play a significant role in the proper 
management of chronic pain, anxiety, depression, insomnia, and muscle 
spasm. The proper and adequate control of pain has improved the lives 
of millions of Americans with debilitating and painful conditions. 
Prescription medications are essential to high quality cancer pain 
management. However, when prescription controlled substances are 
abused, misused, or diverted they can become dangerous and even lethal. 
These types of inappropriate use shed a cloud over this extremely 
important treatment modality, thus making it more difficult for those 
who can truly benefit from this worthwhile approach. The pain community 
has spent years trying to convince physicians, the public, law 
enforcement and legislators about the need to improve access to this 
treatment and over the last 10 years we have seen the barriers 
practically disappear. Today, as many as 90 percent of the patients 
seen in a pain management clinic receive narcotic pain medications 
(either as sole therapy or in addition to other treatments) for the 
treatment of their chronic pain. With this increased access have 
unfortunately come new problems as we have seen with the rampant spread 
of these medications on the streets of America.

              NON-MEDICAL USE OF PRESCRIPTION MEDICATIONS

    We are all familiar with the recent Oxycontin crisis, but this is 
only one of the medications with which we see diversion and abuse. In 
fact, hydrocodone (also known as Vicoden or Lortab) and Percocet are 
more widely abused and easily obtained on our streets. Millions of 
patients are addicted to and misusing these medications to the 
detriment of their own health. These individuals are becoming addicted 
to very powerful medications that can be legally obtained in any 
pharmacy. When used for non-medical purposes, these medications are as 
dangerous as heroin, cocaine, ecstasy, and other illicit drugs. Because 
of their ready availability, many addicts have converted to using 
prescription medications from typical street drugs. This problem and 
source of drugs, has become as important, as the illicit drugs that 
come across our borders.
    The non-medical use of prescription drugs has blossomed into one of 
the most serious health problems in this country. The wide spread 
availability of these highly addictive medications through illegal 
diversion and theft has resulted in a national health care epidemic. 
Since these medications can be obtained through legal channels, it has 
presented an extreme challenge to law enforcement in this country. 
Recent statistics show that the United States consumes 80 percent of 
all legal opioids produced worldwide. This is in large part due to the 
high quality of our medical system and the emphasis that is placed in 
this country on adequately and properly treating pain. This 
availability also demonstrates why these medications have replaced 
heroin and other illicit drugs as popular drugs on our streets. With 
this increased availability comes increased responsibility and, hence, 
the need for H.R. 3015 or NASPER (National All Schedule Prescription 
Electronic Reporting Act).

                             DRUG DIVERSION

    Prescription drug diversion can occur many ways but by far the most 
common form of diversion in this country occurs via what we call 
``doctor shopping.'' Those who seek to abuse or misuse medications for 
their own purpose also use this approach. Doctor shopping refers to the 
activity of obtaining medications from more than one physician at the 
same time, as demonstrated in the recent case of Rush Limbaugh. This 
source of diversion would be readily reduced, if not eliminated, by a 
program such as NASPER. Currently, it is impossible in most States for 
physicians to prevent this activity due to an inability to obtain the 
necessary information. As the borders have been tightened, drug dealers 
have discovered new ways to obtain drug supplies to push on our 
innocent youth. Prescription medication abuse and diversion is a 
serious problem because of the powerful nature of these pure, and 
potentially addictive, medications. It is these legal prescription 
medications that are now finding their way to the streets of America. 
Current DEA estimates suggest that at least 4.7 million people are 
using prescription medications illegally in this country. An estimated 
994,000 Americans received treatment for prescription drug abuse in 
2002.

                             THE DARK SIDE

    Last week in my area, an 18 year old and recent New Fairfield, CT 
high school graduate, died, from what his sisters and friends confirmed 
was an Oxycontin overdose. The newspapers described him as ``a man of 
great compassion . . . he was a happy boy. He had a lot of friends and 
he wouldn't hurt anyone.'' To his friends and family, this is an 
incredible loss; ``I'm going to hurt till the day I die'' said his 
father. Let this example be a message to us all, a wake-up call that it 
is within our power, the ability to decrease the availability of these 
medications on the street. If we can prevent this from happening to one 
other individual, what is this worth? To hundreds? To thousands? What 
if this was your child? While NASPER will not completely eliminate the 
street availability of all prescription controlled substances, it will 
go a long way in this regard. If we can prevent our children from 
trying these powerful medications, by eliminating or at least markedly 
restricting their street availability, we can prevent addiction and the 
horrible and possibly fatal consequences. The State of Connecticut 
Medical Examiners office deals with an estimated 10-15 new overdose 
deaths/week; many of these are related to prescription medications 
(estimated at close to 1,000 in the last several years).

                              THE SUPPLIER

    Four years ago, I found that one of my patients was photocopying 
and forging my prescriptions. He had obtained over 4,000 Oxycontin tabs 
from six different pharmacies in a 5-month period (this is what we 
could track down by randomly calling pharmacies and might have been 
just the tip of the iceberg). He was not taking all of these 
medications but was most certainly selling them on the street, 
presumably one of the biggest suppliers in his town at the time. How 
many became addicted on a long-term basis because of this one 
individual? We will never know. We caught him by dumb luck, but with 
NASPER the pharmacist would have had access to this information and 
could have stopped this before it began.

                         CURRENT STATE PROGRAMS

    While approximately 15 States (CA, HI, ID, IL, IN, KY, MA, MI, NV, 
NY, OK, RI, TX, UT, and WA) currently have some form of electronic 
monitoring program (two more--VA and FL--are pursuing programs), only 
two allow physicians and/or pharmacists access to this information. 
Doctors are on the front line of this battle and it is our licenses 
that are at jeopardy when a patient abuses or diverts their 
medications. How can we be expected to properly monitor and prevent our 
patients from becoming addicted to these very powerful medications if 
our access to this information is restricted? These medications are 
safe when used properly, but dangerous and potentially lethal when used 
improperly. Many pain medications including the most abused medication 
in this country, Hydrocodone, come mixed with acetaminophen (Tylenol). 
Patients who take excessive amounts of acetaminophen can develop liver 
and/or kidney disease.
    The 15 State programs have a common goal of reducing prescription 
drug abuse and diversion but vary in their objectives, design, and 
operation. They do not communicate nor share information with each 
other on an on-going basis. Only four of the State programs collect 
information on schedule II, III, and IV controlled substances, one 
collects data on schedule II and III, and the rest II only. (Schedule 
II includes morphine, oxycodone-Oxycontin, methadone, etc.; schedule 
III includes hydrocodone-vicoden, Tylenol with codeine, etc.; and 
schedule IV includes sedatives such as Valium, Xanax, etc.). Since the 
most widely abused medication in the U.S. is hydrocodone (this has been 
shown in multiple studies), it is clear that the majority of State 
programs inadequately address the whole problem (only 5 of 15 programs 
collect information on schedule III controlled substances). Most of the 
State programs were designed and implemented to assist law enforcement 
in identifying and preventing drug diversion but do not allow the 
physician or pharmacist to participate in this quest.
    KASPER, the Kentucky program which served as the model for NASPER 
was designed after, is often quoted as the most effective program in 
the country. Unfortunately, due to the lack of an effective and 
comprehensive program in neighboring States, this program has not fully 
achieved what it is capable of. This is due to the highly mobile nature 
of our society and the ease with which patients can obtain medications 
in adjacent States. To be truly effective, we need a national program 
with each State collecting similar data and which allows physician 
access to the information from all States. I am from Connecticut and 
within 1 to 2 hours can drive to six other States (PA, NY, NJ, MA, RI, 
VT, NH). A single State program without exchange of information would 
not completely address the problem of doctor shopping.

           HAROLD ROGERS PRESCRIPTION DRUG MONITORING PROGRAM

    The Harold Rogers Prescription Drug Monitoring Program, which began 
to receive funding in 2002, encouraged, but did not require, each State 
to institute an electronic monitoring program. It placed no 
requirements on what information was to be collected (schedule II, III, 
and/or IV), nor did it encourage physician or pharmacist access to this 
information. There were no provisions for exchange of information 
between States, due in part, to the lack of uniformity between 
programs. As we have learned, those involved in prescription drug abuse 
and diversion are smart and adaptable. To circumvent this solution 
these individuals began to cross State lines to obtain additional 
medications, often selecting adjacent States without an electronic 
monitoring program. In addition, many States dealing with budget 
deficits, elected not to start their own programs due to insufficient 
funding through this program (one of the reasons that Connecticut has 
no program). While the intentions of this program were good and 
Congressman Rogers should be commended for this initial effort, we have 
discovered many deficiencies, which have been addressed and dealt with 
in NASPER.

       DEA'S ROLE IN PRESCRIPTION MEDICATION ABUSE AND DIVERSION

    The DEA is able to control diversion at the wholesale level with 
regulatory, nationwide monitoring databases and investigative 
activities, but cannot effectively deal with diversion at the retail 
level. It simply does not and cannot have the necessary manpower to 
accomplish this effectively. From a privacy standpoint, even if the DEA 
could accomplish this monumental task, it would be better, and make 
more sense, for the physician to monitor his/her own patients.
    A Massachusetts DEA report in 2004 describes, ``well-organized 
doctor shopping rings, forged and/or altered prescriptions, and 
diversion from individual prescriptions are the most commonly found 
diversion methods in the State.'' NASPER, through physician and 
pharmacist involvement, would stop these forms of diversion. The DEA's 
report on Connecticut states that ``diverted pharmaceuticals are also 
prevalently abused in CT . . . the diversion and abuse of prescription 
opiates such as Oxycontin, Vicoden, and Percocet are increasing 
rapidly. Diverted pharmaceuticals typically are obtained through common 
diversion techniques including prescription fraud, improper prescribing 
practices, ``doctor shopping'', and pharmacy theft.'' In Alabama, the 
DEA report states that ``Oxycontin is still the number one drug abused 
across the State . . . Alabama is a major market for Dilaudid. 
Distribution in Alabama (of Dilaudid) has increased due to the fact 
that the price of heroin in the New York area has fallen dramatically 
causing the bottom to fall out of the market for Dilaudid. Distribution 
networks have targeted metropolitan areas of Alabama, as the price they 
receive for Dilaudid in Alabama is higher.''

                        STATE MEDICAID SPENDING

    It has been reported that some States have increased drug spending 
within the Medicaid system by as much as 65 percent in 2003. As you are 
aware, Medicaid programs provide medications at government expense to 
those who cannot afford their own healthcare. The State of 
Connecticut's Medicaid program spent $11.7 million on 44,500 Oxycontin 
prescriptions in 2003. The State of Massachusetts' Medicaid system 
spent over $20 million in both 2003 and 2004 on Oxycontin (over 80,000 
prescriptions each year). In Massachusetts, Oxycontin was the seventh 
most costly medication in total dollars spent and was the 26th most 
prescribed medication within the State Medicaid program. Percocet was 
the fourth most prescribed medication (a less expensive medication, so 
in total dollars more is spent on Oxycontin). Studies have shown that 
the incidence of abuse and diversion within the Medicaid systems is 2-3 
times that of the general population and approaches 20 percent. In a 
soon to be published study by Manchikanti et al., patients with only 
Medicaid coverage showed a 39 percent incidence of illicit drug usage 
as compared to 17 percent with third party insurance (Medicare patients 
with/without third party coverage were only 10 percent). Combining the 
use of illicit drugs and misuse of prescription medications showed the 
highest incidence in the Medicaid group, 60 percent (versus 24 percent 
in the Medicare group with/without third party insurance). The money 
saved directly by limiting drug diversion and abuse in this population 
will in itself easily pay for the NASPER program. Just as importantly, 
with NASPER, we will be protecting America from at least one major 
source of medication that is reaching our streets.
    The majority of money spent on substance abuse comes from Federal 
sources with our national drug control policy on track to spend over 
$12 billion in 2005. HHS funds 32 percent of the $572 billion spent on 
Medicaid (or $183 billion) programs. It is estimated that 15 percent of 
the Medicaid recipients abuse/misuse prescription medications. A 1 
percent savings to Medicaid will result in a saving of $1.83 billion 
and more realistically this could approach 5 percent or $9 billion. A 
comprehensive controlled substance monitoring program will result in 
significant cost savings from this point of view alone and clearly 
makes sense. The center on Addiction and Substance Abuse (CASA), in 
1995, performed an extensive study of the costs of substance abuse to 
Federal entitlement programs and found that healthcare and disability 
costs alone were $77.6 billion. The Levin group projected the economic 
costs of drug abuse in 2000 at $160.7 billion. The proposed 2005 budget 
from the White House for prescription drug diversion control will 
increase from $20 million to $138 million, with most of the funds 
directed at reducing the non-medical use of prescription drugs.

                             BEYOND NASPER

    More needs to be done than NASPER, but this will be a great start. 
The Internet remains a major problem and will need to be addressed. I 
would urge you to create a task force to deal with this rapidly growing 
problem. Tens of thousands of people in this country are becoming 
addicted to narcotic medications that they obtain through the Internet. 
I have placed three people into rehabilitation programs who bought 
their medications over the Internet and subsequently became addicted in 
this fashion. We must also address the availability of qualified drug 
rehabilitation programs and ensure insurance coverage for those who 
have traveled down the wrong pathway. Many of the available beds in our 
drug rehabilitation programs are now occupied by recovering 
prescription drug addicts. Preventive medicine, as can be accomplished 
with NASPER, represents the better solution, especially given the high 
incidence of recidivism with this disease (estimated between 50-80 
percent).

                            PRIVACY CONCERNS

    The most common objection that I have heard in regard to NASPER has 
to do with privacy issues. We have, however, taken tremendous 
safeguards to protect patient's privacy. First, this program is fully 
HIPPA compliant. Patients must sign a release in order for the 
physician or pharmacist to obtain information. Anyone obtaining 
information, other than the patient's pharmacist or physician, (or 
these individuals without appropriate consent), is subject to a fine of 
$25,000 per offense. Law enforcement only has access to this 
information through appropriately obtained subpoenas, showing just 
cause. I am frequently asked ``what about the patient who won't sign 
the release of information.'' This will certainly lead to a discussion 
between the patient and the physician, and of course, will raise 
suspicions. Some patients may have a justified reason, others will not.
    All States, regardless of whether there is a State prescription 
monitoring program or not, already have the authority under State laws 
to conduct investigations of the records of individuals alleged to be 
involved in prescription drug diversion and abuse, including the 
records of prescribing physicians and dispensing pharmacies.
    I have explained NASPER to many of my patients who are taking 
chronic medications legitimately, and asked if they would object to the 
government collecting this information. Uniformly they have all said 
``no'', because for them it will help legitimize what they are doing 
and will take away some of the stigma associated with taking chronic 
pain medications. They resent being adversely labeled because of those 
who choose to abuse and misuse this treatment approach. The abuse and 
diversion of drugs to inappropriate sources, does as much to hurt the 
treatment of pain in this country, than the under treatment that we so 
frequently hear about.

                       THE DECADE OF PAIN CONTROL

    The United States Congress has declared the decade of 2001-2010 the 
``Decade of Pain Control.'' The use of chronic narcotic pain 
medications to treat pain is now well accepted by most individuals in 
this country. Therefore, there should not be a stigma attached to 
someone who is taking these medications for medically appropriate and 
indicated reasons. Abuse and diversion undermine the great efforts and 
advances that we have achieved in this treatment arena. Our ability to 
limit these factors will only help to foster the appropriate use of 
medications for the treatment of pain.
    Patients will benefit from the NASPER program by improving the 
treatment of pain through reduced suspicions, increased access, and 
improved physician comfort in prescribing medications. Patients who are 
doctor shopping will benefit from earlier physician intervention. This 
program will help to stabilize and improve the patient-physician 
relationship. Law enforcement cannot possibly keep up with the 
increasing number of drug sales, associated criminal activities, DUI's 
and other related activities. NASPER will help law enforcement do their 
job more effectively by decreasing the availability of one major source 
of drugs.

                  STAND TOGETHER--AMERICA NEEDS NASPER

    NASPER is a bipartisan piece of legislation that is good for 
America and that every legislator should support. In this election 
year, which has more than enough division and partisanship, we ask both 
Democrats and Republicans to stand together on the important issue of 
prescription drug abuse and show this country that both parties are 
committed to protecting Americans. As an actively practicing pain 
physician, I understand that it is important to treat pain; this is 
something I do every day (I perform over 10,000 patient visits per year 
in my practice), but I also recognize that we must deal with this 
rapidly growing problem. While there is clearly a role for these 
medications, they must be controlled and used properly or they can be 
dangerous. Perhaps the pendulum has swung too far the other way. I 
believe that narcotic medications are safe and medically appropriate 
for the treatment of pain, provided that they are prescribed and 
controlled by a single provider. This is good medicine. That doctor, at 
his own choosing, can decide what is the right dosage for a given 
patient; but when multiple physicians are prescribing simultaneously, 
this is a prescription for disaster.

                               CONCLUSION

    Senators, I don't care much for politics but I do care about the 
right cause, and that is what makes sense for the safety of our 
patients. NASPER will not only improve quality of patient care, but 
also make America a safer place. We have an obligation to do whatever 
we can to protect the children of our country (including my 11 and 13 
year old) by reducing the supplies of prescription medications on the 
streets. NASPER makes sense for this country at this time; it will 
eliminate or at least significantly decrease one of the largest sources 
of prescription medications being diverted for non-medical purposes. It 
will help prevent patient substance abuse, decrease the chance of 
addiction due to better physician medication monitoring, and lower the 
number of people requiring drug rehabilitation (patients, true addicts, 
and the misguided who were unlucky enough to get involved in the ``Oxy-
Craze'').
    The costs are minimal to start and operate this program. In reality 
the program will more than pay for itself through decreased 
expenditures on medications within the Medicaid system and soon to be 
available Medicare prescription benefit plans. It will also decrease 
healthcare costs in terms of fewer ER visits, reduced number of rehab 
program visits (long-term), and other related healthcare expenditures 
(including cases of HIV). How often does a bill, supporting a new 
program, actually result in a net savings? Perhaps the most important 
benefit of H.R. 3015/NASPER, is its positive effects on family life, as 
opposed to the destructive effects that these medications can have, 
when taken improperly and for non-medical reasons. How many human lives 
will NASPER save? Can we afford to continue ignoring this problem?

    [Whereupon, at 3:20 p.m., the committee was adjourned.]

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