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45–316 PDF 2008

NASPER: WHY HAS THE NATIONAL ALL

SCHEDULES PRESCRIPTION ELECTRONIC

REPORTING ACT NOT BEEN IMPLEMENTED?

HEARING

BEFORE THE

SUBCOMMITTEE ON OVERSIGHT AND

INVESTIGATIONS

OF THE

COMMITTEE ON ENERGY AND

COMMERCE

HOUSE OF REPRESENTATIVES

ONE HUNDRED TENTH CONGRESS

FIRST SESSION

OCTOBER 24, 2007

Serial No. 110–73

(

Printed for the use of the Committee on Energy and Commerce

energycommerce.house.gov
COMMITTEE ON ENERGY AND COMMERCE

JOHN D. DINGELL, Michigan, Chairman

HENRY A. WAXMAN, California

EDWARD J. MARKEY, Massachusetts

RICK BOUCHER, Virginia

EDOLPHUS TOWNS, New York

FRANK PALLONE, JR., New Jersey

BART GORDON, Tennessee

BOBBY L. RUSH, Illinois

ANNA G. ESHOO, California

BART STUPAK, Michigan

ELIOT L. ENGEL, New York

ALBERT R. WYNN, Maryland

GENE GREEN, Texas

DIANA DEGETTE, Colorado

Vice Chairman

LOIS CAPPS, California

MICHAEL F. DOYLE, Pennsylvania

JANE HARMAN, California

TOM ALLEN, Maine

JAN SCHAKOWSKY, Illinois

HILDA L. SOLIS, California

CHARLES A. GONZALEZ, Texas

JAY INSLEE, Washington

TAMMY BALDWIN, Wisconsin

MIKE ROSS, Arkansas

DARLENE HOOLEY, Oregon

ANTHONY D. WEINER, New York

JIM MATHESON, Utah

G.K. BUTTERFIELD, North Carolina

CHARLIE MELANCON, Louisiana

JOHN BARROW, Georgia

BARON P. HILL, Indiana

JOE BARTON, Texas

Ranking Member

RALPH M. HALL, Texas

J. DENNIS HASTERT, Illinois

FRED UPTON, Michigan

CLIFF STEARNS, Florida

NATHAN DEAL, Georgia

ED WHITFIELD, Kentucky

BARBARA CUBIN, Wyoming

JOHN SHIMKUS, Illinois

HEATHER WILSON, New Mexico

JOHN B. SHADEGG, Arizona

CHARLES W. ‘‘CHIP’’ PICKERING,

Mississippi

VITO FOSSELLA, New York

STEVE BUYER, Indiana

GEORGE RADANOVICH, California

JOSEPH R. PITTS, Pennsylvania

MARY BONO, California

GREG WALDEN, Oregon

LEE TERRY, Nebraska

MIKE FERGUSON, New Jersey

MIKE ROGERS, Michigan

SUE WILKINS MYRICK, North Carolina

JOHN SULLIVAN, Oklahoma

TIM MURPHY, Pennsylvania

MICHAEL C. BURGESS, Texas

MARSHA BLACKBURN, Tennessee

PROFESSIONAL STAFF

DENNIS B. FITZGIBBONS, Chief of Staff

GREGG A. ROTHSCHILD, Chief Counsel

SHARON E. DAVIS, Chief Clerk

DAVID L. CAVICKE, Minority Staff Director

(II)
(III)

SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS

BART STUPAK, Michigan, Chairman

DIANA DeGETTE, Colorado

CHARLIE MELANCON, Louisiana

Vice Chairman

HENRY A. WAXMAN, California

GENE GREEN, Texas

MIKE DOYLE, Pennsylvania

JAN SCHAKOWSKY, Illinois

JAY INSLEE, Washington

JOHN D. DINGELL, Michigan (ex officio)

ED WHITFIELD, Kentucky

Ranking Member

GREG WALDEN, Oregon

MIKE FERGUSON, New Jersey

TIM MURPHY, Pennsylvania

MICHAEL C. BURGESS, Texas

MARSHA BLACKBURN, Tennessee

JOE BARTON, Texas (ex officio)

(V)

C O N T E N T S

Page

Hon. Bart Stupak, a Representative in Congress from the State of Michigan,

opening statement ................................................................................................ 1

Hon. Ed Whitfield, a Representative in Congress from the State of Kentucky,

opening statement ................................................................................................ 3

Hon. John D. Dingell, a Representative in Congress from the State of Michigan, prepared statement ...................................................................................... 4

Hon. Joe Barton, a Representative in Congress from the State of Texas,

prepared statement .............................................................................................. 5

Hon. Frank Pallone Jr., a Representative in Congress from the State of

New Jersey, prepared statement ........................................................................ 6

Hon. Gene Green, a Representative in Congress from the State of Texas,

opening statement ................................................................................................ 7

Hon. Michael C. Burgess, a Representative in Congress from the State of

Texas, opening statement .................................................................................... 8

Hon. Jan Schakowsky, a Representative in Congress from the State of Illinois, opening statement ....................................................................................... 10

Hon. Tim Murphy, a Representative in Congress from the State of Pennsylvania, opening statement .................................................................................... 11

Hon. Diana DeGette, a Representative in Congress from the State of Colorado, opening statement ...................................................................................... 12

Prepared statement .......................................................................................... 13

WITNESSES

Len Paulozzi, M.D., medical epidemiologist, Division of Unintentional Injury

Prevention, National Center for Injury Prevention and Control, Centers

for Disease Control and Prevention, U.S. Department of Health and Human

Services ................................................................................................................. 14

Prepared statement .......................................................................................... 16

H. Westley Clark, M.D., Director, Center for Substance Abuse Treatment,

Substance Abuse and Mental Health Services Administration, U.S. Department of Health and Human Services ................................................................. 36

Prepared statement .......................................................................................... 38

Andrea M. Trescot, M.D., president, American Society of Interventional Pain

Physicians; director, Pain Fellowship ................................................................. 60

Prepared statement .......................................................................................... 62

SUBMITTED MATERIAL

‘‘What is a Pill Mill?’’ CBS News, June 1, 2007 .................................................... 97

Letter of October 23, 2007 from Charles M. Grudem, M.D., to Andrea Trescot,

M.D. ....................................................................................................................... 98

Letter of Gayle B. Harrell, State representative, Florida House of Representatives ....................................................................................................................... 101

Subcommitte exhibit binder .................................................................................... 102
(1)

NASPER: WHY HAS THE NATIONAL ALL

SCHEDULES PRESCRIPTION ELECTRONIC

REPORTING ACT NOT BEEN IMPLEMENTED?

WEDNESDAY, OCTOBER 24, 2007

HOUSE OF REPRESENTATIVES,

SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS,

COMMITTEE ON ENERGY AND COMMERCE,

Washington, DC.

The subcommittee met, pursuant to call, at 10:05 a.m., in room

2123 of the Rayburn House Office Building, Hon. Bart Stupak

(chairman) presiding.

Members present: Representatives DeGette, Green, Schakowsky,

Pallone, Whitfield, Murphy, and Burgess.

Staff present: Kristine Blackwood, Joanne Royce, Scott Schloegel,

Kyle Chapman, Alan Slobodin, and Karen Christian.

OPENING STATEMENT OF HON. BART STUPAK, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF MICHIGAN

Mr. STUPAK. The subcommittee will come to order. Today we

have a hearing on ‘‘NASPER: Why Has the National All Schedules

Prescription Electronic Reporting Act Not Been Implemented?’’

Each Member will be recognized for a 5-minute opening statement.

I will begin.

More than 2 years ago, with wide-spread support in both the

House and Senate, Congress passed the National All Schedules

Electronic Reporting Act, otherwise known as NASPER. NASPER

established a grant program at the Department of Health and

Human Services to foster the development of prescription drug

monitoring programs in every State. These drug monitoring programs will provide a safe, comprehensive, and balanced approach

to stop the growing epidemic of prescription drug abuse by detecting and preventing doctor shopping for addictive drugs.

I was pleased to join with my good friends, Ed Whitfield, ranking

member of this subcommittee, full committee Chairman John Dingell, Ranking Member Mr. Barton, as well as Congressman

Pallone, chairman of our Health Subcommittee, to work and have

Congress pass this comprehensive program to provide the tools necessary to the physicians, pharmacists, and law enforcement for

fighting prescription drug abuse. In passing NASPER, Congress

recognized that prescription drug abuse cannot be fought only by

law enforcement. It is not enough to simply prosecute pill mills and

drug addicts to solve this complex problem. Identifying the pill

mills and prosecuting dealers occurs after the pill pushers have
2

been in business for months or years, spreading the devastation to

the addicts, their families and communities.

Congress passed NASPER because we understand that, in addition to putting drug dealers behind bars, we must ensure that physicians, pharmacists, and public health officials have the resources

they need to identify and stop drug addiction before it begins.

NASPER would enhance that so physicians have immediate access

to patients’ prescription drug history. NASPER would give pharmacists the ability to thwart doctor shopping by patients and drug

dealers. NASPER would ensure that patients are not being overprescribed pain medicine or taking dangerous combinations of prescription drugs. NASPER would ensure that public health officials

could review prescribing patterns, educate, and warn physicians

about medication risk. At the same time, NASPER ensures that

law enforcement will have access to prescription drug data to support their investigations and prosecutions.

In short, NASPER recognizes that prescription drug addiction is

both a law enforcement, medical, and a public health problem. Congress granted HHS oversight of the NASPER Program because we

believe that the program fits best within HHS’s public health mission. NASPER calls upon the Secretary of HHS to issue regulations

with public input to ensure uniformity among the States’ prescription drug monitoring programs. If drug monitoring programs receive real-time and uniform electronic data, States can share critical drug data abuses while effectively protecting patient privacy.

The NASPER Program will benefit from HHS expertise and experience in addition to prevention, treatment, and medical privacy law,

health information, and e-prescribing technology. Moreover,

NASPER can be integrated with the prescription drug benefit programs run by Medicaid and Medicare programs and help the Food

and Drug Administration to monitor the post-market effect of prescription drugs.

This administration has failed to provide any funding to implement the NASPER Program. Instead, the administration has promoted and funded a drug addiction program at the Department of

Justice that was never authorized by Congress, a program that emphasizes the law enforcement aspect of prescription drug epidemic

at the expense of public health concerns.

The purpose of today’s hearing is to determine why the will of

Congress has been ignored. We will hear from three distinguished

witnesses this morning. First we will hear from Dr. Leonard

Paulozzi. Am I saying that correct, sir?

Dr. PAULOZZI. It is Paulozzi.

Mr. STUPAK. Paulozzi, from the Centers of Disease Control and

Prevention in Atlanta, and he is a nationally recognized expert on

prescription drug abuse trends. Dr. Paulozzi’s testimony will provide troubling evidence that the epidemic of prescription drug

abuse is getting worse, not better. Next, we will hear from Dr.

Westley Clark, the Director of the Center for Substance Abuse

Treatment at the Substance Abuse and Mental Health Services Administration of HHS. Dr. Clark is an expert in addiction treatment

and prevention and leads the Agency’s effort to provide effective

and accessible treatment to Americans with addictive disorders.

Our third witness will be Dr. Andrea Trescot, the president of the
3

American Society for Interventional Pain Physicians, or ASIPP. In

addition to her leadership role with ASIPP, Dr. Trescot is a Director of Pain Fellowship Program at the University of Florida. Dr.

Trescot will provide the physician’s perspective on the importance

of implementing NASPER.

Let me advise members that we are setting up a meeting with

the Office of Management and Budget. This subcommittee requested that OMB testify before us to gain a better understanding

of the administration funding goals. Unfortunately, Director Nussle

could not make it, but he will be meeting with us at 3:30 p.m.

Thursday. Let me be clear. This subcommittee and this committee

are committed to carrying out the NASPER Program, and we hope

the administration will join us. I thank the witnesses for appearing

today, and I look forward to their testimony.

Next, let me yield to my friend and one of the advocates of the

NASPER Program, Mr. Whitfield from Kentucky, for an opening

statement, please.

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

Mr. WHITFIELD. Chairman Stupak, thank you very much. I want

to thank you for convening this important hearing.

Back in 2005, many members of the Energy and Commerce Committee co-sponsored legislation, the NASPER legislation, which was

passed by the House of Representatives under the suspension calendar, and about 3 days later passed the U.S. Senate, and then

President Bush signed NASPER into law on August 11, 2005.

NASPER was the product of strong bipartisan support. It was

passed by the committee by voice vote after hearing testimony

about the epidemic of prescription drug abuse in this country. The

members of this committee and the House and Senate felt compelled to create a Federal prescription drug monitoring program to

reinforce the State programs and to ensure that these programs

were interoperable, that information could be shared, that the

NASPER law also provided a basic guideline and had mandates in

it so that every program had to meet certain specifications. It allows physicians to obtain information about their patient so that

they can identify and treat a possible addiction. It also allows law

enforcement to access prescribing information so that they can

build investigations against doctors and patients who abuse the

healthcare system by improperly prescribing or obtaining prescription drugs.

Yet almost 2 years after NASPER was signed into law by the

President, not a single dollar has been requested by the administration, by OMB, and I am not sure, Dr. Clark, that even HHS has

asked for any dollars for this program when you compiled your

budget requests and sent them to OMB. As Chairman Stupak said,

we have talked to OMB, we invited OMB to come and testify, and

they said they would like to meet with us privately on this issue.

But I would like to stress what Chairman Stupak said. The only

program in existence today is a non-authorized program that the

Appropriations Committee decided that they would fund without

any hearings, without any checks and balance on the system. They

simply provided the money, and the first year after NASPER was
4

signed, we all sat in a room, appropriators and Energy and Commerce people, and Chairman Barton was very emphatic in that

meeting that NASPER was going to be funded. We agreed to fund

NASPER to the tune of $5 million, and the Department of Justice

system was funded for $5 million, but due to the continuing resolution, funding for NASPER was never appropriated. And we asked

Chairman Dingell to get involved in this issue because it does go

to the jurisdiction of this committee. We have jurisdiction over this

issue, but more important than that, more important than jurisdiction, is which program is the best program?

The DOJ program is focused on law enforcement. NASPER is focused on providing information for physicians so that they can best

treat their patients, who may be suffering from drug addiction, and

we know that drug addiction is a serious problem around the country. And I know that Dr. Paulozzi will talk about that in his testimony. And I also noted that, Dr. Clark, we are glad you are here

today, but I noticed in your testimony you don’t mention anything

about NASPER. You are talking about the DOJ program, but the

DOJ program was not authorized by anyone, and appropriators

don’t have jurisdiction over the program. We have jurisdiction.

And so I look forward to the testimony today, because this is a

program passed by Congress, signed by the President, and someone

has the responsibility and obligation to fund this program, not because this committee passed it, but because it is the best program,

the one most likely to succeed. So, with that, Mr. Chairman, I will

yield back the balance of my time.

Mr. STUPAK. I thank the gentleman. I ask for unanimous consent

to enter Chairman Dingell’s statement in the record, and that

statement of all members will be entered in the record, whether

they appear or if they just provide a statement.

[The prepared statements of Messrs. Dingell, Barton, and

Pallone follow:]

PREPARED STATEMENT OF HON. JOHN D. DINGELL, A REPRESENTATIVE IN CONGRESS

FROM THE STATE OF MICHIGAN

Mr. Chairman, thank you for holding this hearing on implementation of the National All Schedules Prescription Electronic Reporting Act (NASPER).

The NASPER legislation was passed by the 109th Congress and signed into law

by the President in 2005. Although the NASPER Program was enacted 2 years ago,

this administration has done virtually nothing to implement it and has failed to include any money for the program in its annual budgets. It is vitally important to

our system of government that when Congress establishes national policy by passing

laws, those laws are not simply ignored by the executive branch. Today, I hope we

learn more about the benefits of this program as well as the reason for the administration’s failure to seek funding for it.

In order to solve the problem of prescription drug abuse, we need a multi-pronged

approach. We cannot solve the complex problems associated with abuse and addiction with criminal enforcement alone. We need to enlist physicians, pharmacists,

and other healthcare professionals in the fight. A robust, nationwide system of prescription drug monitoring programs will help medical professionals prescribe responsibly. Strong monitoring systems can allow physicians to promptly identify patients

at risk for addiction and get them into treatment, and avoid patients who are ‘‘doctor shopping’’ to feed their own addiction or to sell their drugs to other addicts.

NASPER would provide a strong monitoring tool to help not only law enforcement

but also the medical community stop the ‘‘pill-pushing’’ and ‘‘doctor shopping’’ that

has devastated so many of our communities over the last decade. Especially in rural

areas, where isolated physicians and pharmacies can easily be manipulated by addicts who travel from community to community to get their fix for illegal pharmaceuticals, NASPER would ensure that these healthcare providers know what drugs
5

their patients have recently obtained or have tried to obtain in other communities

including those across State lines.

As you know, Mr. Chairman, our State of Michigan has a strong prescription

drug-monitoring program. Ninety-five percent of the requests Michigan’s program

receives are from doctors and pharmacists seeking to ensure that patients are getting the medicine they need for genuine medical purposes, not medicine that will

be used for illicit purposes. I am interested in hearing from our witnesses how

Michigan’s program compares with others around the Nation and how NASPER

could enhance these programs.

I commend Ranking Member Whitfield for his leadership on this issue, and I

thank our witnesses for their testimony today.

PREPARED STATEMENT OF HON. JOE BARTON, A REPRESENTATIVE IN CONGRESS FROM

THE STATE OF TEXAS

Thank you, Chairman Stupak and Ranking Member Whitfield, for holding this

hearing on the status of the National All Schedules Prescription Electronic Reporting Act.

NASPER is the result of broad, bipartisan and bicameral cooperation of the kind

that we don’t see much anymore. It passed this committee over 2 years ago by voice

vote. The House passed it as a suspension bill, and the Senate passed it by unanimous consent. The President signed NASPER into law on August 11, 2005.

NASPER was so successful as legislation because its purpose was so transparent

and simple. The law created grants to help fund state prescription drug monitoring

programs. The idea, as I noted 2 years ago when we passed NASPER, is that States

be able to work with each other to stop the abuse of prescription drugs. NASPER

starts the States on the road to cooperation by making certain that they each collect

the same information. So instead of 50 separate monitoring programs with 50 different data sets that don’t jibe, States collect the same data and then share it. Real

interoperability means we can detect illicit prescription-drug operations when the

drug dealers shift across state lines. Without NASPER, unfortunately, drug abusers

and their dealers can still prescription-shop in some States because some information isn’t being shared. That’s a problem, and we’re here today to start fixing it.

The Energy and Commerce Committee was also concerned about protecting the

privacy of Americans whose information is held in the prescription drug databases.

NASPER establishes strict criteria governing the use and disclosure of the information that states must meet in order to receive funding. Without NASPER, there are

no minimum standards to protect the personal information held in prescription drug

monitoring program databases.

Despite these positive features, NASPER has not yet been funded. Although the

President signed the bill, funding for this important program was not included in

the President’s budget. On January 10, 2006, several of us on the committee—including Chairman Dingell, Mr. Whitfield, Mr. Stupak, Mr. Deal, and Mr. Pallone—

wrote to then-director of the Office of Management and Budget Joshua Bolton, requesting the inclusion of $15 million in the administration’s fiscal year 2007 budget

for NASPER. To get NASPER launched, there has to be a budget request. At the

February 6, 2007 full committee hearing on the HHS fiscal year 2008 budget, HHS

Secretary Michael Leavitt testified that HHS supported the program, but that OMB

decided not to include a budget request for it. I understand that we have not even

received a reply to the January 10, 2006 letter.

We had hoped to have a witness from the Office of Management and Budget here

today to explain OMB’s reluctance. Instead, I understand that OMB Director Jim

Nussle has agreed to meet with Mr. Whitfield and other members of this subcommittee in the near future to discuss the status of NASPER’s funding. I hope that

Director Nussle can finally answer the question we put to two of his predecessors:

Why hasn’t the administration included a request to fund NASPER in its budgets?

The problem of prescription drug abuse doesn’t seem to be curing itself, and it isn’t

as if the issue is either partisan or even mildly controversial. We are here today

to find out why nothing has happened.

I am committed to ensuring that NASPER is funded. Last year, I raised a point

of order to the appropriations bill for the Commerce, Justice, and State Departments

because funding was included in that bill for an unauthorized prescription drug

monitoring program at the Justice Department while no appropriations were provided for NASPER. I trust now that they are in the majority, Committee Chairman

Dingell and Subcommittee Chairman Stupak will continue to make this committee’s

concerns about the lack of funding for NASPER known to our colleagues here in the

House and to the Administration. I suspect I can count on it, in fact.
6

Thank you, again, Chairman Stupak and Ranking Member Whitfield. I yield back

the balance of my time.

PREPARED STATEMENT OF HON. FRANK PALLONE, JR., A REPRESENTATIVE IN

CONGRESS FROM THE STATE OF NEW JERSEY

Thank you, Mr. Chairman, for holding this hearing and allowing me to participate. I am pleased to be here today to discuss the importance of prescription drug

monitoring. The bipartisan legislation we are reviewing today was signed into law

by President Bush in 2005, But today, more than 2 years later, it has still not been

funded. As the only program authorized in statute to assist states in combating prescription drug abuse, it is crucial that we work to ensure the Act receives the funding needed for implementation.

At the time this legislation was passed, members on both sides of the aisle agreed

that rampant prescription drug misuse and abuse was a growing problem. And now,

2 years later, it is still a growing problem. In fact, the diversion of prescription

drugs is one of the fastest growing areas of drug abuse in our Nation today. It is

a problem that is blind to geographic regions, blind to age, and blind to income-levels. And according to the data, it affects 9 million Americans.

In my home State of New Jersey alone, 4.1 percent of our residents have abused

prescription drugs in the past year. The per capita retail distribution of the pain

medication oxycodone increased 181 percent between 2000 and 2005. For

hydrocodone, another pain medication, it increased 66 percent during that same

timeframe.

Some States have already begun developing the means to stop this escalating

trend, and Congress agreed back in 2005 that the NASPER Act was the best way

to aid States in their efforts to ensure that prescription drugs are only being used

for medical purposes, in the correct way, and that they are not getting into the

hands of people who would abuse them.

The solution presented through NASPER is to create a better monitoring and

tracking system for prescription drugs. And studies have shown these types of programs to be very effective. The five States with the lowest number of oxycodone,

specifically OxyContin prescriptions per capita, have long-standing prescription

monitoring programs and report no significant prescription drug diversion problems.

While at the same time, the five states with the highest number of OxyContin prescriptions per capita do not have prescription monitoring programs and have reported severe abuse problems.

This data strengthens the argument that health care practitioners and pharmacists desperately need electronic monitoring systems to ensure that they are prescribing and dispensing Schedule II, III, and IV Controlled Substances that are

medically necessary. And NASPER assists them in this area.

As passed in 2005, NASPER would provide grants to help States develop or expand a prescription drug-monitoring program that has the ability to communicate

with monitoring programs in other States. Any Controlled Substance II, III, or IV

that is prescribed would be electronically reported by the physician or pharmacist

to the State’s primary monitoring authority. Upon certified request, physicians and

law enforcement can access the information in these databases, in an effort to prevent prescription drug addiction and to crack down on bad actors who are contributing to the problem.

Without these interconnected databanks, practitioners and pharmacists have no

way of knowing with any certainty whether a particular patient has received the

same drug or another incompatible controlled substance already from another practitioner.

This is particularly troubling in light of the fact that physicians are increasingly

more hesitant to prescribe these medications out of fear that they will be the ones

to take the fall if a patient is in fact ‘‘doctor shopping’’ and abusing these substances. More and more patients have to suffer from intense pain because doctors

are overly cautious in prescribing the medications they need. A program like the one

we are discussing today would protect the innocent provide them with the information they need to make the correct decisions for their patients.

The NASPER bill passed Congress and was signed into law in August 2005.

Thanks to its passage, I firmly believe that we will move one step closer in providing a strong and effective approach to addressing prescription drug abuse and crime.

But our fight is not over, just because the bill has passed. Now we need to get the

program funded so we can provide the necessary money to States.
7

Because of the strict timetable set forth in NASPER, it is vital that funding be

included in fiscal year 2008 to ensure that HHS is able to promulgate regulations

and seek public input, thereby allowing grants to be awarded this year.

My colleague from Kentucky, Ed Whitfield, and I are busy working towards

achieving that goal. We have sent a letter to appropriators requesting $15 million

in funding for NASPER in fiscal year 2008. I have the letter here, Mr. Chairman,

and would like to submit it for the record. We have also been speaking with members of the appropriations committee urging them to fulfill our request.

And I would like to thank you again, Mr. Chairman, for having this very important hearing today. I am hopeful that we will be able to get this program funded

this year. I would also like to thank all the witnesses for joining us and I look forward to your testimony.

Mr. STUPAK.With that, next I would move to Mr. Green for opening statement, please.

OPENING STATEMENT OF HON. GENE GREEN, A

REPRESENTATIVE IN CONGRESS FROM THE STATE OF TEXAS

Mr. GREEN. Thank you, Mr. Chairman, for ordering this hearing

on prescription drug monitoring programs and the NASPER Program, which Congress enacted in 2005. High-ranking member Mr.

Whitfield was the author of the National All Schedules Prescription

Electronic Reporting Act, and I was proud to be a co-sponsor and

support it when it went through both our committee and both the

108 and 109th Congress. The need for NASPER is clear to us,

being on both the law enforcement level and a drug safety level.

With State prescription drug monitoring programs sporadic and not

interoperable, it was relatively easy for individuals who abuse prescription drugs to doctor shop for controlled substances or obtain

the prescription drugs illegally with little detection from physicians

or law enforcement.

The Texas prescription drug monitoring program, called the

Texas Prescription Program, was established more than 25 years

ago, in 1981. Each year the Texas Prescription Program collects 3.3

million prescriptions and monitors Schedule II prescription drugs.

During the first year of the Texas Prescription Drug enactment,

the number of Schedule II prescriptions filled in the State fell by

52 percent. The program helped the State crack down on pill mills

and forged prescriptions, but it is clearly a law enforcement program and housed at the Texas Department of Public Safety. Without question, prescription drug monitoring programs offer significant benefits for law enforcement. They should go hand in hand

with the drug safety and public health benefits. It is disturbing

that the administration doesn’t recognize these dual needs and implement the NASPER Program.

Mr. Whitfield, this committee purposely housed NASPER with

the Department of HHS to strike the appropriate balance between

law enforcement activities and public health safeguards. In fact,

the criteria for grant awards ensured a certain level of interoperability, timely reporting by pharmacies, and assurances for patients of privacy. By giving physicians access to the data compiled

by prescription drug monitoring programs, NASPER would also

help physicians coordinate care and reduce the number of contraindicated drugs prescribed to patients. The administration’s refusal

to implement this program suggests it is only interested in law enforcement aspects of prescription drug monitoring programs.
8

Secretary Leavitt supported this conclusion when he appeared

before this committee earlier this year and cited OMB’s decision to

review these programs as law enforcement tools, while the administration’s synthetic drug control strategy and drug monitoring program is at the Department of Justice. The problem is, neither the

administration’s synthetic drug control strategy nor the DOJ grant

program ever has been authorized by Congress. My State received

the welcomed grant funding through the DOJ programs, but the

DOJ programs only provide half a loaf. Within the DOJ program,

there is no real strategy for interoperability, which is critical if we

want to stop folks from hopping across State lines to obtain prescription drugs illegally and escape detections from their home

State monitoring programs. The DOJ programs also have none of

the safeguards for patient privacy and pay little to no attention to

public health ramifications.

Like my colleagues, I wish OMB Director Nussle would have appeared before us today and explained the administration’s rationale

for failing to implement NASPER. However, I am pleased that he

has agreed to meet with our Chair and ranking member to discuss

the important issue. I hope that Mr. Nussle, as a former member

of this chamber, will be able to understand the frustrations we feel

when the administrations ignore Congressional intent. And I would

like to thank the Chair and the ranking member for holding this

hearing and needed oversight over the administration’s inaction on

this issue and shed light on the administration’s missed opportunity to address the problem of prescription drug abuse in an effective manner. And again, I am glad our witnesses are here.

Mr. Chairman, I yield back my time.

Mr. STUPAK. Thank you, Mr. Green. Mr. Burgess, for an opening

statement, please.

OPENING STATEMENT OF HON. MICHAEL C. BURGESS, A

REPRESENTATIVE IN CONGRESS FROM THE STATE OF TEXAS

Mr. BURGESS. Thank you, Mr. Chairman, and I appreciate very

much you holding this hearing today. Back in my home State of

Texas, in the city of Dallas, the Dallas Morning News ran a series

of several articles, 2003, 2004, 2005, on a physician who ran a pill

mill. And it seems that everyone knew about the pill mill. He didn’t

make appointments, but he saw a lot of patients, and the patients

were seen, I guess you would call it kind of a modified wave method of making appointments. The patients would sleep in the parking lot so they would be the first in line to get in the door the next

day, and in fact sometimes the clinic had to hire off-duty police officers to kind of keep order in the parking lot before the clinic

opened. The doctor would see 200 patients a day. They were mostly

Medicaid and Medicare beneficiaries. In fact, this office was the

source for the largest single source of Diazepam prescriptions for

Medicaid prescriptions in the State of Texas. Now, at least 11 of

his patients died, and they died of drug overdoses or drug complications, and after a very long investigation, culminating just a few

weeks ago, this doctor received probation. I think, had this program, had NASPER been up and running and functioning, I think

he certainly could have been contained much earlier, and I think
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some patients and their families could have foregone some needless

suffering, and perhaps we could have even avoided loss of life.

Now, when NASPER was signed into law, August 11, 2005, it

was the only congressionally authorized program to assist State

prescription drug monitoring programs. The previous program established by the Department of Justice was created with a lack of

adequate Congressional oversight and appropriate administration

by the Justice Department. Both parties agreed that such a program should have strict guidelines and that Health and Human

Services is better suited to administer such a program than the Department of Justice. So NASPER must be funded, especially to

guard against scenarios such as this that has been well documented in my papers back home.

Well, Chairman Stupak, I thank you and ranking member

Whitfield for holding the appropriators accountable, and I join in

asking them to make the Appropriations Committee aware and to

fund this program.

And NASPER could allow doctors to find out what medications

a patient is currently taking and what he or she has taken in the

past. Without a database in place for doctors to track patient history, doctors have no way of knowing who is really in pain and who

is looking to abuse the system, and I speak of this with some authority because I was a practicing physician back in Texas for 25

years, and I certainly know. I got caught in similar situations. I do

have some questions. I have some questions about how this is affected by our current HIPAA laws, and then, going further, how is

the law that we recently passed, the Genetic Information Non-Discrimination Act, how is that going to affect the sharing of information, because that bill was fairly broadly constructed and I think

may have more of an effect on this that will curtail the sharing of

data. Now a database is extremely powerful, extremely powerful in

helping to manage a patient’s care and helping to provide information to caregivers about a patient’s status.

We had a situation in Dallas right after Hurricane Katrina landed in New Orleans 2 years ago. A lot of folks were taken from the

Superdome in Louisiana and delivered to the parking lot outside

Reunion Arena in Dallas. Many of these people were patients who

were on multiple medications. Many of them had been without

their medications for several days, and some were just a few steps

away from getting into serious trouble with their underlying illness. One of the chain pharmacies set up a mobile unit right outside Reunion Arena, and doctors were able to quickly access the

database, get information about the patients. Obviously Charity

Hospital didn’t have electronic medical records up online, but this

data was available to the doctors who were receiving those patients

and triaging those patients in the parking lot of Reunion Arena,

and within a very short period of time were able to accommodate

those patients’ needs. And I think out of the many, many thousands of people who were transferred from New Orleans to Dallas,

only a few required hospitalization, because they got timely treatment and timely recognition on the night of their arrival. So it just

underscores how powerful a database can be if used appropriately.

Mr. Whitfield alluded to how important it is to have interoperability of databases, and I certainly think that is key if we are
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going to have two side-by-side systems. Clearly they need to be

able to communicate with each other in efficient fashion. But realistically if we could have a single system that worked and was

funded, I think that is the preferable route to go.

With that, Mr. Chairman, I will yield back the balance of my

time.

Mr. STUPAK. Thank you. Next opening statement, Ms.

Schakowsky, please.

OPENING STATEMENT OF HON. JAN SCHAKOWSKY, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF ILLINOIS

Ms. SCHAKOWSKY. Thank you, Mr. Chairman. This is an important hearing for a couple of reasons. First, we all know that prescription drug abuse is rising and that accidental deaths from overdose have increased dramatically. But in addition, we know that

over 2 years ago this Congress passed, and the President signed

into law, aimed at fighting this growing problem. And yet to date,

as people have said, but I think it bears repeating, no funds have

been included in the President’s budget for the implementation of

this bipartisan bill, the NASPER.

Without a doubt, there is a need for a tool to reduce prescription

drug abuse. For many of our communities, this is an ever-growing

problem that has resulted in the death of too many friends and

neighbors and family members. According to this committee’s

records, when HHS Secretary Michael Leavitt testified before this

committee on the President’s 2008 budget, he stated that the Department supported the program and that it was a program that

he would gladly administer. Yet, when pressed further, he deferred

to the OMB, stating that it was up to them to make a final decision. And meanwhile, over the past several years, the Department

of Justice has made annual grants to a number of States for the

purpose of establishing or strengthening a prescription drug monitoring program. These grants have been supported both through

Congressional earmarks and the President’s budget requests, so

the question I look forward to answering today is why NASPER

has yet to be implemented or funded despite administration support for the prescription drug monitoring. Additionally, I look forward to hearing from our witnesses regarding what appears to be

this administration’s preference to house the prescription drug

tracking program at a law enforcement agency, as opposed to the

Department of Health and Human Services. I have concerns about

what this means for patient privacy and preserving the relationship between patients and their physicians.

It is also important that we examine the disadvantages of relying

on the DOJ grant program, a competitive grant program which has

yet to reach all States. Furthermore, State PDMPs have remained

largely incompatible. If our best interests lay in exposing bad actors within the prescription drug arena, our system must be interoperable and attainable for all States. So I look forward to getting

some answers from our witnesses, and I thank them all for being

here today, and I yield back.

Mr. STUPAK. I thank the gentle lady. Mr. Pallone was here, and

he had to step out, but unfortunately Mr. Pallone is not a member

of the subcommittee, so he may not be allowed to make an opening
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statement but may be back to ask questions. But it should be

noted, as I noted in my opening statement, it was Mr. Pallone, as

ranking member of the Health Subcommittee, who helped push

this legislation through and critical in getting it passed and signed

into law. We appreciate his continued interest, and hopefully he

will be able to make it back in time for questions. With that, Mr.

Murphy, for an opening statement, member of the subcommittee.

OPENING STATEMENT OF HON. TIM MURPHY, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF PENNSYLVANIA

Mr. MURPHY. Thank you, Mr. Chairman, and thank you for holding this important hearing. In particular because we are all very

concerned about the abuse of prescription drugs, it should be noted

that high school students in the United States and college students

are declining in their abuse of illicit drugs for consecutive years,

but there is an increasing level of the abuse of prescription drugs

among youth and adults. And it is cause for concern, and it is an

area that we need to closely monitor. And what we are considering

today is a mechanism by which we can do this.

I would like to quote briefly from an article that appeared in the

Pittsburgh Post Gazette earlier this year, in March, where in reference to an interview with a Dr. Neil Capretto of the Gateway Rehabilitation Center in Pittsburgh, he said, ‘‘There has been a growing non-medical addictive use of prescription drugs, particularly

opioid drugs like Oxycontin, codeine, morphine, Percocet, Vicodin,

and Dilaudid. Opiates possess more properties characteristic of

opioid narcotics like heroin and morphine but are not derived from

opium poppy.’’ He went on to say, ‘‘The good news is, we are treating pain better than we did 10 years ago. The bad news is, there

are more people abusing and misusing prescription drugs. Unfortunately, from our end, I am really afraid it is going to get worse before it gets better.’’

As of 2003, 6.3 million Americans used prescription drugs for

non-medical purposes. In 2002 almost 30 million people had used

prescription pain relievers for non-medical purposes. Prescription

medications are now involved in close to 30 percent of drug-related

emergency room visits. The most recent monitoring, the Future Report from University of Michigan, found that 5.5 percent of all high

school seniors abuse Oxycontin. Oxycontin abuse has increased 26

percent since 2002 among 8th- and 9th- and 12th-graders. The

abuse of prescription drugs cuts across gender, race, and virtually

all groups.

As we look at programs like NASPER, it is disappointing that it

has not been funded, and that is why we are here today. The Appropriations Committee continues to fund a program out of DOJ

that focuses solely on enforcement. Although we are pleased that

DOJ has this program, and I don’t necessarily have a problem with

the DOJ program, but we have rules in place for a reason. Why

should we fund an unauthorized program when we have an authorized program that accomplishes the same mission? With that said,

we do agree on the mission, to prevent prescription drug abuse. In

my many years of practice as a psychologist, I saw the wretched

examples of drug abuse first-hand. And as we look at this, my

questions will be, how can we make these programs work together?
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How can we make them be effective and efficient, not redundant

or exclusive? How can we gather and share data and databases so

we can work with law enforcement officials, we can work with drug

treatment programs, and we will work with effective funding here

in Congress?

I don’t believe there is anybody here who does not consider it a

high mission of this Congress to make sure we do all we can to reduce prescription drug abuse and all drug abuse, for that matter.

Because people understand how they can doctor shop, because

databases are not clear, it stands as a barrier to enforcement. It

stands as a barrier to treatment, and unfortunately it is the system

that the drug abuser has figured out how to get around for now.

We have to close those doors if we are going to help people. And

again, reflecting on the statistics I read earlier, about 8th- and 9thand 12th-graders, it would be a real tragedy if we did not work to

make this program work, to make this program and the Department of Justice program find a way of working together so that our

goal of Justice and our goals in Congress of reducing and eliminating prescription drug abuse are met.

I look forward to hearing the testimony of this hearing of how

we can reach those goals, and I yield back my time, Mr. Chairman.

Mr. STUPAK. Thank you. Ms. DeGette, for an opening statement,

please.

OPENING STATEMENT OF HON. DIANA DEGETTE, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF COLORADO

Ms. DEGETTE. Thank you, Mr. Chairman. Mr. Chairman, I will

submit my full statement for the record, but I just want to say that

a couple of months ago I read one of those articles that really opens

your eyes in the New York Times Magazine—about patients who

truly have chronic pain that affects their whole ability to conduct

their lives. And these patients are really stuck in a whipsaw, because on the one hand they are trying to get medications that will

help solve their pain, and there are many legitimate doctors now

who say that patients like these really do need very high doses of

pain medication. But these patients are caught because they are

identified as abusers of these medications. And, at the same time

then, you have people who really are abusers of these medications,

and they are illegally obtaining these drugs. I think that NASPER

would really help to bring some sense to this situation and allow

the legitimate patients to get the drugs that they need, so that they

can get pain relief while at the same time giving law enforcement

the tools to track and identify both the abusers of these drugs and

the physicians who are participating in some of the abuses. So I

think it is a real shame on behalf of the patient and on behalf of

law enforcement that we haven’t funded NASPER, and I know that

talks are continuing. I would hope that the administration would

really put some funding behind this very important program.

With that, Mr. Chairman, I will yield back.

[The prepared statement of Ms. DeGette follows:]
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PREPARED STATEMENT OF HON. DIANA DEGETTE, A REPRESENTATIVE IN CONGRESS

FROM THE STATE OF COLORADO

Mr. Chairman, let me begin by thanking you for holding this hearing on the National All Schedules Prescription Electronic Reporting Act, a vital tool for ensuring

public health and safety.

Sadly, drug abuse has become an all-too-familiar issue, whether it be illicit drugs

or drugs prescribed for pain relief. Chronic pain, for example, is a legitimate concern

with legitimate treatment options, yet prescription pain killers are often abused. We

need a way to allow patients access to such drugs when they are appropriate, while

at the same time adequately controlling access and identifying patients who are at

risk of addiction or are so-called ‘‘doctor shoppers.’’ We passed NASPER and signed

it into law in 2005 for exactly these reasons, yet nothing has come of the program

to date.

NASPER would give law enforcement personnel access to drug monitoring data

that relates to illegal prescribing, dispensing, or procurement of controlled substances, while also providing reliable data to doctors in the form of ‘‘prescription histories’’ for their patients. Prescription histories not only help to identify doctor shoppers, but also help doctors identify patients who might at risk of addiction and

would therefore be better-suited to an alternative, less addictive drug. Just as importantly, it would enable doctors and patients to avoid potentially deadly drug

interactions that occur when patients see multiple doctors for different conditions

but neglect to inform the doctor of other prescriptions they may be taking.

NASPER does all this while providing privacy safeguards for patient protection

and without placing pressure on doctors to avoid prescribing medicine that is legitimately needed.

NASPER has the potential to be of immense value, yet because the Administration has failed to provide funding for it, it has not been able to help a soul.

In fact, the administration has instead funded a different, unauthorized prescription drug monitoring program through the Department of Justice. This does not

make much sense to me, especially given that the DOJ program lacks some of

NASPER’s key components.

For example, the DOJ program lacks interoperability requirements that would

allow States to share data—a key problem that we are seeing repeatedly with current Health Information Technology initiatives. NASPER, on the other hand, includes such interoperability provisions.

Mr. Chairman, I would like to know why the administration is yet again dismissing Congress’ authority—by not only failing to fund NASPER, but by instead funding an unauthorized program.

I yield back the balance of my time.

Mr. STUPAK. Thank you. That concludes the opening statements

by members of the subcommittee.

We have our first panel before us. On our first panel we have Dr.

Westley Clark, Director of the Center of Substance Abuse Treatment within the Department of Health and Human Services, Substance Abuse and Mental Health Services Administration,

SAMHSA, as we call it, and Dr. Len Paulozzi, a medical epidemiologist at the Centers for Disease Control and Prevention. It

is the policy of this subcommittee to take all testimony under oath.

Please be advised that witnesses, under the rules of the House,

have the right to be advised by counsel during testimony. Do either

of you gentlemen wish to be advised by counsel during your testimony?

Dr. PAULOZZI. No.

Dr. CLARK. No.

Mr. STUPAK. Both indicate they do not. Therefore I will ask, since

it is tradition to take testimony under oath, please rise, and raise

your right hand to take the oath.

[Witnesses sworn]

Mr. STUPAK. Let the record reflect both witnesses replied in the

affirmative. You are now under oath. We will begin with your open-
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ing statements. Dr. Paulozzi, would you like to go first for 5 minutes for an opening statement, please, and thank you again for appearing.

TESTIMONY OF LEN PAULOZZI, M.D., MEDICAL EPIDEMIOLOGIST, DIVISION OF UNINTENTIONAL INJURY PREVENTION,

NATIONAL CENTER FOR INJURY PREVENTION AND CONTROL, CENTERS FOR DISEASE CONTROL AND PREVENTION,

U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES

Dr. PAULOZZI. Good morning, Chairman Stupak, Ranking Member Whitfield, and distinguished members of the subcommittee. My

name is Dr. Leonard Paulozzi, and I am a medical epidemiologist

at the Centers for Disease Control and Prevention. I am here on

behalf of the CDC Director, Dr. Julie Gerberding. My remarks will

focus on drug poisoning involving prescription drugs in the United

States as a public health problem. Can I have the second slide?

[Slide]

By way of background, this figure shows the leading causes of

unintentional or, if you will, accidental injury death in the United

States in 2004. The green bar is motor vehicle deaths. The yellow

bar in the center is poisoning, which ranks as the second-leading

cause of unintentional injury death, with approximately 20,000

deaths from this cause in the year 2004, of which 95 percent of

these poisoning deaths are drug overdoses. Next slide.

[Slide]

The problem here is this upward trending line. This is drug poisoning death rates in the United States from 1970 through 2004.

You can appreciate the trend line and the dramatic increase in the

1990’s and the first years of this decade. We can explain some of

the earlier blips with black-tar heroin or crack cocaine, but the

problem was explaining what happened in the later years of the

1990’s. Next slide.

[Slide]

We did a study which looked at the death certificates to identify

the drugs that were listed there as causing these deaths. We broke

it down into three types, heroin in white, cocaine in yellow, and the

red line at the top, pointed by my marker, is the opioid analgesic

category. You can see it is going up dramatically. It outnumbers either heroin or cocaine by the year 2004. And this opioid analgesic

category, of course, is the narcotic painkillers like Oxycontin and

Vicodin that you have heard so much about. Next slide, please.

[Slide]

Again, this is the drug mortality death rate line that you saw before. I have paired it with opioid sales, shown here in green. These

are sales per capita, shown from 1997 on. From 1997 to 2004, the

opioid sales increased six-fold, and the line closely tracks the death

rate in drug poisoning. The other thing to note is that, 2005 and

2006 sales continued to go up, so we expect further increases in the

drug poisoning death rate in 2005 and 2006. Indeed, preliminary

information from 2005 suggests that the death rate did rise in

2005. Next slide, please.

[Slide]

This shows the drug poisoning death rates in the United States.

The dark States are those with the top third of death rates. I would
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like to point out that we have traditionally high rates in the Southwest. Louisiana, Maine, are also high, but we have a band of

States, Appalachian States, from Tennessee to Pennsylvania, with

some of the highest rates in the country. And as late as 1990, these

same Appalachian States had some of the lowest rates in the country. So this has really affected rural States more than urban States

in this particular prescription drug problem. Next slide.

[Slide]

Well, death certificates don’t tell you circumstances of the death.

So how do you know whether these are accidents of people taking

too many pills, or are these abuse? We think that these are primarily related to misuse and abuse of prescription drugs, for three

reasons. People dying of the prescription drugs are largely middleaged males: the same groups who died of heroin and cocaine in earlier years. Surveys from SAMHSA have annually shown steady increases in prescription drug misuse, non-medical use rates in the

United States. And lastly, studies done by medical examiners have

found that the decendents from prescription drug deaths typically

or commonly will have a history of substance abuse. Next slide.

[Slide]

How can the problem be addressed? Obviously this is a multi-factorial, complicated problem, and solving it depends upon input

from multiple Federal and State agencies. CDC will continue to respond to this problem, as it has, through surveillance activities, epidemiological work, and through evaluation of potential interventions. In the next year, CDC will focus on a study of prescription

drug deaths and poisoning victims. We will also start an evaluation

of prescription drug monitoring programs, and we are working with

the Association of State and Territorial Health Officials to look at

State-specific policy responses to this problem.

Thank you for the opportunity to appear here today to make you

aware of the serious health consequences of this growing misuse of

prescription drugs in the United States, and I will be happy to answer any questions you may have.

[The prepared statement of Dr. Paulozzi follows:]
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Mr. STUPAK. Thank you, Dr. Paulozzi. Dr. Clark, your opening

statement, please, sir.

TESTIMONY OF H. WESTLEY CLARK, M.D., DIRECTOR, CENTER

FOR SUBSTANCE ABUSE TREATMENT, SUBSTANCE ABUSE

AND MENTAL HEALTH SERVICES ADMINISTRATION, U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES

Dr. CLARK. Mr. Chairman, members of the subcommittee, my

name is Dr. H. Westley Clark, and I am the Director of the Centers

for Substance Abuse Treatment, within the Substance Abuse and

Mental Health Services Administration, an agency of the U.S. Department of Health and Human Services. I am testifying on behalf

of our Administrator, Terry Cline, Ph.D., who was not able to be

here. I am a board certified psychiatrist with added qualification

in addiction and psychiatry.

According to SAMHSA’s National Survey on Drug Use and

Health, combined data from the reports from 2002 to 2006 indicate

that an average of 4.7 percent of persons age 12 and older, an estimated 12.6 million people, used prescription pain relievers nonmedically in the 12 months prior to the survey. 2006, 2.1 percent

of persons age 12 and older used a prescription pain reliever nonmedically in the month prior to the survey. Among persons 12 and

older, 2.2 million initiated non-medical use of prescription pain relievers within the past year, and that is about the same as the estimated number of initiates for marijuana.

Where do people obtain their drugs? The 2006 National Survey

on Drug Use and Health also revealed where the people were obtaining their prescription drugs. Nearly 56 percent of the patients

who had non-medical use of prescription pain relievers obtained the

drugs free of charge from a friend or a relative, 19.1 percent from

a single doctor; 14.8 percent bought or took them from a relative

or a friend; 3.9 percent bought from a drug dealer or other stranger; 1.6 percent got them from more than one doctor; less than 1

percent reported getting them from the Internet; and 4.9 percent

got them from other sources, including a fake prescription, or stole

them from a doctor’s office, clinic, or hospital pharmacy. As a result, it is clear that what we need is a coordinated response.

The emerging challenge of prescription drug abuse and misuse is

a complex issue that requires epidemiologic surveillance, distribution chain integrity, intervention, more research by both the private and the public sectors. We also need to be concerned about the

issue of the appropriate use of prescription drugs. We know that

there are some 75 million people who are suffering from severe

pain. Some 50 million people suffer from chronic pain, and some 25

million people suffer from acute pain. So the Federal Government

needs to work with medical partners, public health administrators,

State legislatures, international organizations, are all needed to

collaborate and cooperate through educational outreach and other

strategies targeted to a wide swath of distinct populations, including physicians, pharmacists, patients, both intended and inadvertent, educators, parents, high school and college students, high-risk

adults, the elderly, and many others. Outreach to physicians and

their patients and pharmacists needs to be complemented by edu-
37

cation, screening, intervention, and treatment for those misusing or

abusing prescription drugs.

Beginning fiscal year of 2002, Congress appropriated funding to

the Department of Justice to support prescription drug monitoring

programs. Since the inception of the Department of Justice program, called the Harold Rogers Prescription Drug Monitoring Program, this funding opportunity has resulted in 21 States receiving

new program grants and 13 States netting planning grants. There

are now 25 States operating prescription drug monitoring programs

and eight States with legislation in place to establish a program.

In addition to the prescription monitoring programs of the DOJ,

the Federal Government has a number of other activities involving

prescription drugs. We are promulgating guidelines for the appropriate disposal of prescription drugs. These guidelines urge Americans to take unused, unneeded, or expired prescription drugs out

of their original containers and dispose of them appropriately by

mixing the prescription drugs with undesirable substances like coffee grounds or kitty litter to throw them away in the trash. We also

are addressing the issue of prevention and treatment. We have

drug-free communities, and on behalf of ONDCP we administer

grants to communities across the country to form local anti-drug

coalitions. We have spent $1.76 million for our substance abuse

prevention and treatment block grant, $504 million in prevention

and treatment discretionary grant, including our Access to Recovery, our ATR grant. We also have a screening and brief intervention grant. Furthermore, the National Institute of Drug Abuse has

initiated a research program looking at the use of Buprenorphine

for the treatment of prescription opioid abuse.

As I stated earlier, the emerging challenge of prescription drug

abuse and misuse is a complex issue that requires epidemiologic

surveillance, distribution chain integrity, intervention, and more

research by private and public sectors. It requires a concerted effort

by many, and electronic monitoring systems are a key part of the

response, along with treatment and prevention programs that include outreach and education. SAMHSA is committed to allowing

programs to give States and the local authorities the flexibility

they need to deal with the issue and meet the challenge. Our strategy of prevention and treatment is essential to that.

Thank you for the opportunity to present this information to you.

[The prepared statement of Dr. Clark follows:]
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Mr. STUPAK. Thank you, and thank you for your testimony. We

will begin questions. We will go 5 minutes. If need be, we can go

back and forth. Dr. Clark, in your testimony you never mentioned

the NASPER Program. Why is that?

Dr. CLARK. At this particular point in time, the NASPER Program has not been funded, but the components of NASPER are—

we are actively engaged in addressing some of those components

and working——

Mr. STUPAK. Well, if it hasn’t been funded, how can you be actively engaged in addressing the components?

Dr. CLARK. We are involved in the issue of collecting data on prescription drug abuse.

Mr. STUPAK. Why didn’t you fund NASPER or the program that

you have then to help inform doctors of the problems of the prescription drug abuse?

Dr. CLARK. Well, we understand that the funding process is complex. It is my understanding that, through the appropriations process, Congress has chosen to fund these activities within DOJ and

not HHS.

Mr. STUPAK. Well, as Mr. Whitfield said, there was $5 million for

the NASPER Program brought on approximately 2 years ago. What

ever happened to that $5 million for the NASPER Program then?

Dr. CLARK. To my knowledge, we never got $5 million.

Mr. STUPAK. Has SAMHSA ever asked for money for the

NASPER Program?

Dr. CLARK. I am not in a position to discuss the internal deliberations that occur in——

Mr. STUPAK. I am not asking for internal discussions. I am asking if you ever made a request of the appropriators for the

NASPER Program. That is nothing internal. Did the Department

ever ask for funding for the NASPER Program? That is a public

statement. Did you ever do that?

Dr. CLARK. Asking for funds for specific programs is an internal

process that we use, and we follow the internal processes to achieve

that.

Mr. STUPAK. Why is the budget then published every year, if it

is an internal process? It is a public process. The President sends

his budget to Capitol Hill, and then we discuss whether or not to

do it, whether or not to fund certain programs. Has the Department ever made a request to fund NASPER?

Dr. CLARK. To my knowledge, no.

Mr. STUPAK. From a public health perspective, what do you believe are the most important features of NASPER as distinguished

from the unauthorized grant program at the Department of Justice?

Dr. CLARK. I think one of the most important things is that we

want to be able to educate and inform practitioners, and we get

that from the Department of Justice program. We want to make

sure that there is this balance between the appropriate use of pain

medications and the inappropriate use of pain medications. As I

mentioned, there is some 75 million people who suffer from severe

pain in the United States. So the concerted strategy that we are

working with in the Federal Government, we believe, will assist us

in addressing these issues in a cost-conscious environment.
50

Mr. STUPAK. Well, those two that you pointed out, to inform and

educate the doctors who prescribe prescriptions, and also the use

of pain medication, that is not found in the Rogers program in the

Department of Justice, is it?

Dr. CLARK. I am not the best person to comment about the elaborate components of the Department of Justice programs.

Mr. STUPAK. Well, you testified on the Department of Justice

program, so why can’t you comment on the Department of Justice

programs?

Dr. CLARK. I think the Department of Justice programs, in order

to speak with the extreme authority, I think it would be best for

the Department of Justice to comment. We do know that the Department of Justice is very much interested in advancing the public

health component of theirs and not simply to aid in investigation

and law enforcement. We know that they are——

Mr. STUPAK. Well, let me ask you this one, then. Let me ask you

this. Last night at 8 o’clock, your Agency gave our investigators, 8

o’clock last night, a study required by the NASPER legislation. The

study was supposed to be presented to Congress. That was supposed to be done 6 months after the bill was signed into law, which

would have been August 2005, so early 2006 we should have received that report. We never saw the report until last night at 8

p.m. So why was this study a year and a half late? And when was

this study completed?

Dr. CLARK. The study was released yesterday. It required extensive deliberation. We have discovered——

Mr. STUPAK. When was the study completed? I know you released it last night at 8 o’clock. When was it completed?

Dr. CLARK. The study was completed after it was approved, and

I think part of the——

Mr. STUPAK. When was it completed, after it was approved?

Dr. CLARK. It was approved yesterday, sir.

Mr. STUPAK. So it took you 18 months to approve this study?

Dr. CLARK. Yes, sir.

Mr. STUPAK. How long did it sit in the Department, trying to get

its final approval?

Dr. CLARK. I think the Department acted upon the report with

dispatch and due deliberation, so it is not possible for me to comment on where it was after it left, because we have been exchanging comments and deliberations on it. So we have been actively involved in addressing the specifics of the report.

Mr. STUPAK. So you are telling me under oath here today that

you have been actively and specifically going over this report for

the last 18 months?

Dr. CLARK. Well——

Mr. STUPAK. Isn’t the real answer was, you knew you were called

up before this committee, so therefore you released your report last

night? You haven’t been actively engaged in this report. I can tell

that just by looking at the report we saw last night, and I am reminding you, you are under oath. I am not trying to give you a bad

time, but when we ask for things and you come here and you say

you have been actively engaged in this thing for the last 18

months, studying it, and that is why it just got released last night,

that is a bunch of bull. There is no other way to put it.
51

Ms. DEGETTE. Mr. Chairman, if I may. I always say there is a

good reason to have a hearing. You get so much information the

minute you schedule the hearing, so this is just yet another example of it.

Mr. STUPAK. So, do you want to revise your answer on that last

one? Or are you going to stick with actively engaged for the last

18 months?

Dr. CLARK. Oh, we were pursuing the report as expeditiously as

we could, and the final deliberations of the report were completed

when the report was released.

Mr. STUPAK. Mr. Whitfield for questions, please.

Mr. WHITFIELD. Thank you, Chairman Stupak. Dr. Clark, you

mentioned in responding to Mr. Stupak that HHS did not request

any funding for NASPER. Is that correct?

Dr. CLARK. Yes, sir.

Mr. WHITFIELD. And how was that decision made?

Dr. CLARK. Again, I am not at liberty to discuss the internal deliberations that occur every year during the preparation of our annual budget.

Mr. WHITFIELD. Well, Secretary Thompson came and testified before this committee and said they supported NASPER, that it

would be helpful to them in dealing with this problem. Secretary

Leavitt came to this committee, testified to this committee, that

NASPER would be helpful to them to solve this problem. And you

are testifying this morning that you all did not request any money

from OMB in your budget request. Is that correct?

Dr. CLARK. I am testifying that I am not at liberty to discuss the

internal deliberations that occur——

Mr. WHITFIELD. No, but I thought you said you did not request

any funds for this program.

Dr. CLARK. In the public, published budget.

Mr. WHITFIELD. All right. Now, Secretary Leavitt also said that

it was OMB’s decision not to fund this program. Can you make a

comment on that?

Dr. CLARK. I will defer to Secretary Leavitt’s comments.

Mr. WHITFIELD. Well, the point that I would make is that it is

quite obvious from the charts that Dr. Paulozzi has mentioned here

and has shown us that the unintentional drug poisoning death rate

continues to increase. And which would indicate that this program

at DOJ maybe is not being as effective as it could be. Now, the reason that we were excited about NASPER was that the first prescription drug monitoring program in America was established in

1939 in California. And today there are 25 States that actually

have operational programs. So, from 1939 until 2007, only 25

States have operating programs. NASPER mandated that States do

certain things to get these programs up and operational, and as we

stated earlier we had a lot of hearings on this issue. We didn’t just

run an appropriation bill, and put it in an earmark to establish a

program. We had extensive hearings, a lot of testimony, and the

thought was that this program is much more comprehensive, has

guidelines and so forth, and would be much more effective. Now,

let me ask you, has HHS or SAMHSA taken any steps to prepare

for administering NASPER in the event that funding is provided?
52

Dr. CLARK. We have had internal discussions. We have worked

with the medical groups. We have sent staff to the various meetings on prescription monitoring programs, and in fact we also have

an internal working group on electronic health records, which we

believe would be a component of this. We understand that electronic prescribing is a concept that is being promoted, and we believe that, should this issue mature, we would need to be able to

address that. So, yes, we have been addressing some of the collateral issues that we think are essential to prescription monitoring.

Mr. WHITFIELD. I might also say that we feel like in NASPER

there are standards in there protecting patient privacy, which we

think are superior to the DOJ program. I would also say that

NASPER requires that dispensers like pharmacies report each dispensing of a controlled substance no later than one week after the

date the drug was dispensed, and I don’t think that is required on

the DOJ program. And as far as interoperability of these programs,

I mean, it is quite obvious that under the DOJ program not all

these States are able to share information with each other. And I

would just ask Dr. Paulozzi, how often do you all work with HHS?

You are at the Centers for Disease Control. Do you all have a continuing dialogue with HHS on specific programs to address this unintentional drug death issue?

Dr. PAULOZZI. Well, Congressman Whitfield, we have had ongoing discussions with various staff at HHS. We worked with them

very closely on the Fentanyl-heroin contamination issue of a year

or two ago, and subsequently I have been keeping in touch with Dr.

Hoffman at SAMHSA on various issues. But our conversations

have not focused on the prescription drug monitoring program.

Mr. WHITFIELD. Thank you. My time has expired.

Mr. STUPAK. Ms. Schakowsky, for questions, please.

Ms. SCHAKOWSKY. I noticed that you said that you are testifying

on behalf of your Administrator, Terry Cline, who was not able to

be here. What I am also noticing as a consequence, you are not

really able to talk about the funding issues, and I am disappointed

in that because that is really at the center of what this hearing is

about. We are trying to really get at why it is that NASPER has

not been implemented within HHS. Do you think you are the best

person, and, believe me, I am not challenging your role as a psychiatrist and your role at SAMHSA, but do you think you are really

the best person that can explain what this committee is trying to

get at?

Dr. CLARK. I think the committee is going to be meeting with the

director of OMB, and you have already met with the Secretary on

this topic, so I think those are the best people who can comment

on this issue.

Ms. SCHAKOWSKY. Well, we are going to do our best. The study

that was presented to our staff last night, HHS states that there

is no evidence of negative impact on patients’ access to pain treatment, particularly access by children to medicines they need. That

is under the current system, which is the DOJ grant program system. I wonder if you could elaborate on that and if there is a

chilling effect on physicians because of the current system?

Dr. CLARK. One of the things that the report does acknowledge

is that there is a paucity of general information. However, based
53

on the modeling that was done, it does appear that the prescription

modeling programs do have a chilling effect on practitioner behavior. One of the reasons a comprehensive strategy would be helpful,

we are able to provide feedback to practitioners real time so that,

in fact, you don’t have children and adolescents denied care when

that care is legitimate. Massachusetts——

Ms. SCHAKOWSKY. But, can I just interrupt for 1 second? Do you

think the fact that it would be this program, to the extent that it

is implemented, with the prescription drug monitoring programs in

selected States, but the fact that it is housed in a law enforcement

agency, do you think that would add any additional negative impact?

Dr. CLARK. Our hope is that it would not.

Ms. SCHAKOWSKY. What do you mean?

Dr. CLARK. Well, if in fact we are able to establish the linkages

between the DOJ program, the HHS programs, and clinical practice, then we would not have a chilling effect.

Ms. SCHAKOWSKY. Does the DOJ program provide for this coordination of agencies?

Dr. CLARK. I think the DOJ is attempting to achieve that.

Ms. SCHAKOWSKY. So, so far there has not been any coordination.

Do they coordinate with your agency?

Dr. CLARK. Not on a routine basis.

Ms. SCHAKOWSKY. It appears that most States with these

PDMPs, would the PDMP legislation choose to have their program

in health agencies rather than in their law enforcement agencies?

I wonder if you could comment on that.

Dr. CLARK. From the public health point of view, it appears that

in a number of jurisdictions most of the people requesting information are actually prescribers. For instance, Kentucky’s program, the

group requesting reports tends to be, 92 percent were prescribers,

three percent pharmacists, three percent law enforcement, 1 percent licensing board. So the issue is, how do we help physicians

make proper decisions in the care of their patients? And we have

got a system that allows for real-time exchange of information. We

are able to facilitate that.

Ms. SCHAKOWSKY. Thank you. I yield back.

Mr. STUPAK. Mr. Murphy, for questions, please.

Mr. MURPHY. Yes, Mr. Chairman, just a couple quick ones. This

Department of Justice program, how long has it been going on, Dr.

Paulozzi? My understanding is, about five years or so?

Dr. PAULOZZI. Are you referring to the Harold Rogers Program,

Congressman?

Mr. MURPHY. Yes.

Dr. PAULOZZI. I am sorry. I don’t really know when that program

began.

Mr. MURPHY. My understanding, it was first funded around

2002. When I think of the slides you were showing us, it appears

that during that time we have seen some pretty dramatic increases

in drug poisoning and death rates.

Dr. PAULOZZI. That is correct, Congressman.

Mr. MURPHY. And on your slide you were also indicating that—

I am not sure if it is saying it is a correlation, or it is cause and
54

effect that, with regard to the increase in the use of these opioids

and other analgesics?

Dr. PAULOZZI. The trend lines parallel, which is consistent with

a causal relationship. It certainly doesn’t prove one.

Mr. MURPHY. And in the breakdowns in the testimony today,

there is several factors that relatives may give the drugs away,

some sell it, a small percentage are stolen from doctors’ offices and

prescriptions, but generally we trace it with these drugs. My question is this, is the Department of Justice program working?

Dr. PAULOZZI. Congressman Murphy, it is difficult to tell, without

a formal evaluation of that process. It is hard to know what the

rates would have been without interventions in prescription drug

monitoring programs in selected States.

Mr. MURPHY. Sure. A good point. I appreciate that. What I am

wondering here is, when I look back on some testimony that Secretary Leavitt had here, and it was actually in response to some

questioning from my colleague, Mr. Whitfield, in reference to the

NASPER Program he says, ‘‘It is a program we support. It is a program we would gladly administer.’’ He went on to say that it was

OMB that recommended it be in the law enforcement program. My

question is, to each of you, is there a value in doing the NASPER

Program, even from the point of an armchair analyst, since it is not

that it has been tried and found wanting, it has been unfunded and

left untried, it seems to me. Am I correct in that assessment, that

without the funding we don’t know if it works, but we clearly know

that the DOJ program is, during the time that that is in place, we

are seeing an increase in these deaths? I would like both of you to

answer that, too, if you could respond, please. You can point at

each other. That is fine.

Dr. PAULOZZI. As I say, it is difficult to determine what the impact is of Harold Rogers or without a formal evaluation or rigorously-done evaluation to determine what the impact of NASPER

could be. As I say, I think it is difficult to infer evidence of effectiveness or lack of effectiveness from the information we have here.

Mr. MURPHY. Will CDC be doing that kind of evaluation, to find

out if it is working or has a value?

Dr. PAULOZZI. We actually do plan a study to look at the impact

of the initiation of prescription drug monitoring programs of all

kinds on the drug fatality rates in the States that implement them.

Mr. MURPHY. Dr. Clark?

Dr. CLARK. Should it be decided that NASPER should be funded,

I think Secretary Leavitt’s comments would answer your concerns.

So I will defer to Secretary Leavitt’s comments on this matter.

Clearly, the Department is pursuing a number of initiatives which

would envelope the NASPER issues and would allow an aggressive

participation and monitoring of what is going on without sacrificing

patient care.

Mr. MURPHY. Well, and I would hope we are all on the same

page with this, so all I am trying to find is the most effective, most

efficient way, and it seems to me when we team up with people

who are involved with law enforcement and those who are involved

with healthcare delivery monitoring, we could have some value

here. I mean, when we are looking at even such things as electronic medical records, with which one can track who is doing the
55

doctor shopping and getting duplicate drugs, it is a question that

the physician can actually bring up with the patient in the confidential realm of the doctor’s office, not necessarily waiting for the

law enforcement officials, but to say, Mr. Jones, I think you have

gone to several doctors here, and you are taking an awful lot of

Oxycontin here. I am very concerned. And I don’t know if the DOJ

program allows that to happen. Is it? I mean, by design, does the

DOJ program allow that? Do the physicians have access to that

kind of information when they are seeing a patient?

Dr. PAULOZZI. My understanding is that there is nothing blocking

their access to that information, but I would defer to people who

know more about it than I do.

Mr. MURPHY. I am referencing, and there was an article that appeared a couple weeks ago in a newspaper in Pennsylvania, in

Kittanning, Pennsylvania, Armstrong County, which is not in my

district, but I was reading here a quote from a law the Armstrong

County district attorney, Scott Andreassi. He said, ‘‘What is not

happening now is monitoring things like doctor shopping. We need

to take this program a step further and involve the pharmacies and

virtually everyone involved with prescriptions every step of the

way. We are going to discuss it in the future as to how we are

going to talk to one another, exchange information on prescription

drugs and so on.’’ And it makes me wonder, unless there is a misunderstanding of these programs, I am wondering if we are getting

the right information to the right people who can really do the

right thing for patient care? And I would think that those are

under the jurisdiction of HHS and CDC, that we are concerned

about people abusing drugs, doctor shopping, illicit prescriptions, et

cetera, and looking at these together. I would hope that from the

comments that both of you made you are going to help this committee get that information and can bring it to the committee’s attention in the future. I yield back.

Mr. STUPAK. Thank you. Ms. DeGette, do you have questions?

Ms. DEGETTE. Thank you, Mr. Chairman. Dr. Clark, in your prepared testimony, you say, ‘‘Our strategies in prevention and treatment of prescription drug abuse are both targeted specifically to

the prescription drugs themselves and to programs that enable prevention, intervention, and treatment of addictions, which can have

a significant long-term impact on prescription drug abuse and misuse.’’ That is your conclusion. So my question is to you, if those are

your strategies, don’t you think it would be really helpful to have

NASPER to help you achieve those strategies?

Dr. CLARK. Clearly, having access to the electronic matrix where

information is shared real-time between pharmacists and physicians and patients, through their physicians or healthcare provider,

we would be in a much better position to assess the appropriateness of a particular prescription. As a physician, I used to work for

the VA, and we had electronic records. And so when a patient

would come in, I could pull up those records, and I could see what

medication the patient was on, and I could deal with the issues of

synergism, multiple prescriptions, and appropriate——

Ms. DEGETTE. And that is part of what NASPER does, correct?

Dr. CLARK. That is part of what NASPER does, yes.
56

Ms. DEGETTE. So I guess your answer would be, yes, that would

assist you in these important goals of your agency.

Dr. CLARK. Yes.

Ms. DEGETTE. Dr. Paulozzi, I just have a question. I was interested to look at your slide that shows that these incidences of

deaths from overuse of these drugs, both in my area of the country,

the southwestern United States, and also in Appalachia, are greater, and I was wondering if you have any indication of why that

might be. Is it a systems breakdown? Is it for cultural reasons?

What might the reasons be?

Dr. PAULOZZI. Well, thank you for that question, Congresswoman

DeGette. New Mexico used to have the highest drug poisoning mortality rates in the country for many years. And it was thought to

be related to the black-tar heroin, some of it coming in from Mexico, also related to maybe the cultural practices of use of heroin in

that community. Some of the neighboring States to New Mexico’s

rates have gone up, though, in the last 10 or 15 years as well, so

it is not clear to what extent that is prescription drugs and to what

extent it is illicit drugs. But that has really historically been the

focal point for drug poisoning, in the Southwest.

Ms. DEGETTE. And we don’t really know why exactly?

Dr. PAULOZZI. No, I would have to say that there are speculations about illicit drugs and type of heroin use in cultural practices.

Ms. DEGETTE. In your testimony you mentioned a variety of surveillance and examination activities that the CDC will undertake

this year, such as looking at prescription histories. This is one of

the things NASPER does. It gives doctors and officials access to patient histories. So wouldn’t it make sense to use the NASPER Program for this, and especially since it has already been authorized?

Dr. PAULOZZI. Yes, absolutely, Congresswoman. The information

collected by prescription drug monitoring programs could be very

useful to people like myself or State health departments, public

health researchers at all levels, to look at the prescription histories

of people suffering overdoses, to look at the trends in distributions,

in county-by-county distributions across the State. I think it is an

invaluable tool.

Ms. DEGETTE. And you have reported unintentional deaths from

prescription drug abuse is now the second cause of accidental

deaths in this country, second only to traffic accidents. If NASPER

is implemented by HHS, how would the data from PDMP programs

help medical researchers engaged in public health research, like

you?

Dr. PAULOZZI. Well, the data would be very helpful, Congresswoman, in terms of telling us what is happening with distributions

of drugs and trends in sales of drugs. We currently don’t have a

good source of information about that. Proprietary information is

available, but working in the public sector, we can’t afford to buy

it. In addition, the people doing studies, and medical examiners,

just looking at the deaths of individuals, could benefit from being

able to see what their prescription history has been in terms of

helping to determine what led to their death. So there are multiple

applications.

Ms. DEGETTE. And one thing I was just sitting here thinking

about, like with my question to you about why are the deaths high-
57

er in certain regions of the country, if you had that data you could

actually see, is the use or abuse of these prescription drugs greater

in these areas, or is it really illicit drugs, a fact that you can only

speculate on right now? Correct?

Dr. PAULOZZI. Yes, that would be an additional tool. There are

some survey data, though, that are broken down by State, collected

by SAMHSA, about substance abuse that may be useful in that regard.

Ms. DEGETTE. And, Dr. Clark, you were shaking your head. You

think this could be helpful as well, I assume?

Dr. CLARK. Yes.

Ms. DEGETTE. Thank you. Thank you, Mr. Chairman.

Mr. STUPAK. Thank you. Dr. Paulozzi, if I may, Ms. DeGette

asked you about, you mentioned New Mexico and Colorado and the

Appalachian States, and in a map of the States you have the highest drug poisoning rates in the country. And again, in your opinion,

if the prescription drug monitoring programs in those States had

interoperable capabilities, like they would under NASPER, do you

believe that would help decrease the drug poisoning in those

States?

Dr. PAULOZZI. Well, Mr. Chairman, I believe that the prescription

drug monitoring programs are promising tools for that purpose.

They would provide a lot more information in a timely way, both

to regulators, people in public health, and also to physicians in trying to manage care for patients. So there are a lot of reasons to

believe that they would be effective in preventing overdoses, managing care of people with chronic pain better.

Mr. STUPAK. Your data that you used in your study came from

coroners and medical examiners as to the cause of death. How do

coroners and medical examiners determine what types of prescription drugs were involved in these accidental deaths?

Dr. PAULOZZI. Yes, Mr. Chairman. The coroners and medical examiners do complete the death certificates, which are filed, and

then those become the source of the studies that we have done.

They determine the cause of death by a variety of means. They

look at the death scene investigations to see what prescription vials

are there and whether there are syringes that were used to inject

drugs. They also, of course, do toxicologic testing to look for the

drugs found in the decedents’ bodies after death. They will ask

questions about the person’s history, and they may even get the

record from the prescription drug monitoring program, if there is

one in their State, about the person’s prescription history, to look

for signs of abuse of drugs.

Mr. STUPAK. If we had NASPER, that would provide that information readily available to those coroners and others, would it not?

Dr. PAULOZZI. Yes.

Mr. STUPAK. About the prescription drugs?

Dr. PAULOZZI. Yes, Mr. Chairman, it would.

Mr. STUPAK. Thanks. In your testimony you mentioned that

there is a significant correlation between State drug poisoning

rates and State sales of prescription drugs. If you were in charge

of creating a drug monitoring program such as NASPER, would

you choose to house it in a health agency which has jurisdiction
58

over prescription drugs or a law enforcement agency like DOJ, and

why?

Dr. PAULOZZI. Well, that is a complicated question, and I am not

sure I really understand fully the ramifications of those two different choices. I can say on the one hand that there is a lot of use

made of prescription drug monitoring program data by law enforcement. On the other hand, there should be use of NASPER-type

data by physicians. I would hope for a system that would be accessible to everyone who needed access to it, with the appropriate protections of patient privacy, and not have the use be dictated by the

location of the program.

Mr. STUPAK. Thank you. Dr. Clark, in the study you gave to our

staff last night, and SAMHSA spent 18 months massaging it, let

me ask you this. In there, it states that there is evidence of a negative impact on the patient’s access to pain treatment. Are you saying that the Harold Rogers program is negatively impacting patients’ ability to seek proper treatment on legitimate pain diseases?

Dr. CLARK. No, what we are saying is, looking at controlled substance monitoring programs generally so that comment is not targeted toward the Harold Rogers Program. It is saying that when

jurisdictions implement controlled substance monitoring programs,

there is an unintended consequence of practitioners altering their

clinical decision-making because of the existence of such programs.

Mr. STUPAK. The Rogers prescription drug monitoring program

has been around since 2002. Congress has spent $43.5 million. Has

anyone ever assessed the success of that program, if it has been

successful in reducing unintentional deaths in drugs, Mr. Clark?

Dr. CLARK. I don’t think so.

Mr. STUPAK. All right. In your testimony you say that no organization or agency can address the program or the problem alone. A

coordinated response is required. Does the Rogers program provide

this coordination of agencies?

Dr. CLARK. I think under the one-government paradigm we

should be operating with that level of coordination. It hasn’t happened.

Mr. STUPAK. So the Rogers program doesn’t support coordination

amongst agencies, then?

Dr. CLARK. I can’t articulate the explanation for the Rogers program’s activity in that area.

Mr. STUPAK. Well, let me ask you this. Does HHS support the

NASPER Program?

Dr. CLARK. You have heard from Secretary Leavitt. I will defer

to his position on this matter.

Mr. STUPAK. Has Secretary Leavitt seen this report that you

handed to us last night?

Dr. CLARK. That report has been cleared by HHS. I can’t say

whether Secretary Leavitt himself has seen the report.

Mr. STUPAK. Mr. Whitfield, for questions.

Mr. WHITFIELD. Just a couple more. Obviously on an issue as serious as this issue, it is important that the programs, that they be

effective and that there be a way to measure their effectiveness

and that there be adequate oversight. And I would make the argument that, when you do an earmark on an appropriation bill, generally there is no follow-up report to examine its effectiveness at
59

all. In NASPER, there is a requirement that after three years of

operation that HHS conduct a study and determine how effective

the program is. So I think that is one big difference in these programs. The second difference is that, under the existing DOJ program, it relies on the States to determine who has access to the information. And, for example, Indiana and Pennsylvania will not

allow physicians access to the information. The NASPER Program

allows physicians access to the information, allows law enforcement

access to the information, and sets guidelines for privacy protection

concerns. So when you look at these programs, I think the more

balanced program overall certainly is NASPER and I must say that

it is frustrating that the President signs this bill, and still there

is no funding for this program. And it is more important than just

jurisdiction. It is about addressing a serious problem in the country, and that is really what this hearing is all about. Now, Dr.

Clark, let me ask you one question. When you all work with OMB

on your budgetary needs, who, what is the name of the individual

at OMB that you work with? I mean, I know that Leavitt can call

Jim Nussle on the phone, or he can call Rob Portman on the phone,

but at the staff level, who works with who? Between HHS and

their budget requests and OMB?

Dr. CLARK. As I recall, the staff person is an individual named

Patricia Smith.

Mr. WHITFIELD. Patricia Smith? And then, at the White House,

who is the White House liaison with HHS?

Dr. CLARK. I don’t have that information.

Mr. WHITFIELD. Thank you very much.

Mr. STUPAK. Seeing no members with further questions, I would

like to thank this panel for their testimony today. Dr. Paulozzi and

Dr. Clark, thank you for being here.

Dr. CLARK. Thank you.

Dr. PAULOZZI. Thank you.

Mr. STUPAK. We will call up our second panel. We have one witness on our second panel, and that is Dr. Andrea Trescot, president

of the American Society of Interventional Pain Physicians, and she

is also the director of Pain Fellowship at the University of Florida.

We will give you just a minute, Dr. Trescot, and then we are ready

to go. It is the policy of this subcommittee to take all testimony

under oath. Please be advised that the witness has the right, under

the rules of the House, to be advised by counsel during their testimony. Do you wish to be represented by counsel, doctor?

Dr. TRESCOT. No, sir, I do not.

Mr. STUPAK. The witness testifies that she does not, then raise

your right hand and take the oath.

[Witness sworn]

Mr. STUPAK. Thank you. Let the record reflect the witness has

answered in the affirmative. She is now under oath. Dr. Trescot,

if you would, please, just give an opening statement, and then you

may submit a longer statement for inclusion in the record, and we

look forward to questions and answers. Doctor?
60

TESTIMONY OF ANDREA M. TRESCOT, M.D., PRESIDENT, AMERICAN SOCIETY OF INTERVENTIONAL PAIN PHYSICIANS; DIRECTOR, PAIN FELLOWSHIP

Dr. TRESCOT. Thank you. Distinguished Chairman, ranking

member, Members of Congress, and staff, my name is Dr. Andrea

Trescot. I am very grateful for this invitation to speak before you

regarding a critical issue, prescription drug abuse. I am an interventional pain physician with nearly 20 years of private practice

experience, and earlier this year I left private practice to join the

University of Florida and the Gainesville VA as Director of the

Pain Fellowship Program. I am currently the president, as you

said, of the American Society of Interventional Pain Physicians,

ASIPP, a professional society with over 4000 providers. But it is in

my role as a physician, treating patients in agonizing pain, that I

come to you today requesting your help.

Opioid or narcotic use and misuse is a huge and growing problem

in the United States. As you have heard, Americans make up only

4 percent of the world’s population, but they consume nearly 80

percent of the global supply of pain medicines, 99 percent of the

global supply of hydrocodone, one of our very easily obtained

opioids, and two-thirds of the world’s illegal drugs. Despite billions

of dollars thrown at this problem we have not been able to reduce

the Nation’s substance abuse and addiction.

The number of Americans abusing controlled substance drugs

has jumped from 6.2 to 15.2 million in the last 10 years. Among

chronic pain sufferers who receive opioids, one in five abuse those

medications. The number of teen users, who somehow view prescription medicines as being safer, has more than doubled, but the

highest use of pain relievers, non-medically, has been in the 18- to

25-year group. An undercover surveillance video I viewed last week

of a pill mill showed nearly 100 people standing in a doctor’s waiting room, waiting to pick up their narcotics. I was stunned by how

much it looked like a bar scene and then realized it was because

virtually person in the waiting room was under the age of 30. Unfortunately, the elderly are also at risk because of their multiple

medications and potential drug interactions and their multiple degenerative joint changes. Though this population may have significant and legitimate opioid needs, they are at risk for diversion of

their medications, sold for income supplementation or stolen by

caregivers and family members.

Approximately 75 to 90 percent of drug abusers have obtained

their medications legally, and most through a prescription. We feel,

therefore, that the most effective way of controlling this epidemic

is to control the end of the pen, or in other words, how the medicines are prescribed. The White House Office of National Drug

Control Policy, focusing on stopping use before it starts, healing

drug users, and disrupting the market, has spent over $10 million

a year since its enactment in 1988, with no demonstrable curb in

drug abuse or addiction. And yet, almost a quarter of a trillion dollars of the Nation’s yearly healthcare bill is attributed to substance

abuse and addiction.

We feel strongly that NASPER is a major weapon against pre- scription drug abuse. Unfortunately, the ONDCP’s budget of $13

million doesn’t include funding for NASPER, which is arguably the
61

most effective program. To fight drug abuse before the drug is prescribed would require about $10 million, which is less than 1 percent of the current budget and could provide as much as 30 percent

reduction in prescription drug abuse. Now NASPER was based, as

you have heard, on a successful program in Kentucky, KASPER,

which has been effective but limited because Kentucky has seven

border States, allowing patients to take the prescriptions across

State lines to avoid monitoring. One of the most important features

of NASPER was the information sharing across State lines, but

that requires each State to have a monitoring program in place. In

this day of unfunded mandates, the States have been slow to enact

legislation, most of which was inadequately funded and not designed to share information.

I live in north Florida, an hour away from the Georgia border.

Although Florida passed a bill that was named FLASPER, suggesting that it was part of the NASPER Program, the eventual legislation was castrated into a voluntary program of electronic prescribing. We are convinced that, had the funding for NASPER been in

place, the law in Florida would have conformed to the national recommendations, which would have prevented Florida patients from

obtaining narcotics from multiple doctors, whether they were day

laborers or syndicated radio columnists. By identifying those patients who are doctor shopping, physicians will be able to intervene

early with patients who are misusing and abusing their medications, legitimate pain patients will receive access to care they truly

need, and we can shut down the most obvious avenue for obtaining

fraudulent prescriptions.

It is clear the prescription monitoring programs are effective specifically when they are proactive, and we feel NASPER is just such

a program. We at ASIPP also feel that, since less than 40 percent

of physicians receive any kind of training regarding pain evaluation

in medical school, the White House should facilitate the dissemination of pain and addiction information to the general medical community. I have provided the committee with a copy of such an education tool, published last year by the Florida Medical Association.

In closing, the White House has declared a total global war on

terrorism, with a budget of $145 billion. We are asking for only a

tiny fraction of that to battle an insidious and just as deadly internal threat to the welfare of this great Nation. Please help us in

that battle by providing funding for NASPER as one of the major

tools we have in this critical battle. Thank you very much, and I

look forward to answering any questions you might have today and

in the future and perhaps providing additional insight to some of

the questions asked today.

[The prepared statement of Dr. Trescot follows:]
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Mr. STUPAK. Thank you, and I will note you had presented

longer testimony, and some of it was a paper done by Dr.

Laxmaiah Manchikanti.

Dr. TRESCOT. Manchikanti, yes, sir. And that is available in your

packets. That has been published and available on the Web as well.

Mr. STUPAK. Right, and then that will be included in the record.

But I know with the great frustration that our witnesses on the

previous panel from CDC and SAMHSA, officials did not stay to

listen to your testimony. I wish they would have, and I would like

to send them a copy of your testimony and a copy of the pill mill

tape that you did, you shot last week, you said.

Dr. TRESCOT. Yes, sir.

Mr. STUPAK. And so, could you send the committee a copy of that

tape? We would really like to see it.

Dr. TRESCOT. I can actually provide—CBS Evening News did one

actually of Texas, which I was asked to comment on, on air. The

surveillance that I described is on a case that is currently ongoing,

and certainly as soon as that case has adjudicated I am sure that

we would be glad to provide that. Unfortunately, because that case

is——

Mr. STUPAK. Ongoing.

Dr. TRESCOT. That organization is actually currently being investigated. I am not at liberty to release that information.

Mr. STUPAK. When it is, and when you can, if you would, please

provide the committee.

Dr. TRESCOT. I will do the best of my ability.

Mr. STUPAK. It is a great learning tool. Now, one of the things

that, and having practiced medicine I am sure you are well aware

of it, we have seen, and it seems like I always hear stories every

week, that all they did for a senior citizen was change their medication when they went to the hospital, or the medication being received from their family physician and what they received in the

hospital was counteractive to the illness or the disease they are

trying to prevent. Would NASPER help change that or get better

outcomes here? It seems like we are prescribing, multiple doctors

prescribe multiple medications, which does not really help out the

patient at times.

Dr. TRESCOT. That is absolutely a huge problem. Many patients

now are treated at the hospital by a hospitalist and now their family doctor, and there is often a delay in getting the information

from the hospital back to the primary care physician, and unfortunately patients in general don’t often recognize that the name of

one medicine might be the same kind of medicine as another. And

a good example of that would be the difference between Vicodin

and Lortab——

Mr. STUPAK. Sure.

Dr. TRESCOT. Both of which are hydrocodones, both of which

have very different names, and I in my own practice have had patients who have been on both medicines and had no clue they were

exactly the same. That obviously raises the risk of overdose because they are taking two doses of the same medicine. NASPER

would allow us to be able to access that information from all their

locations, from all the prescribers, and to be able to sit down with
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the patient and, medicine by medicine by medicine, be able to look

at the potential drug interactions.

Mr. STUPAK. Well, let me ask this question. The NASPER Program, there are requirements for receiving grant funds that a State

has agreements with bordering States to share information in order

to stop the doctor shopping between the States, and you mentioned

Florida being an hour away from Georgia. Do you see the effects

of Georgia dumping there, or patients going over to Florida from

Georgia and vice versa?

Dr. TRESCOT. There is actually a pill mill in my own community,

and you can drive by that office and see the huge number of Georgia license plates in the parking lot.

Mr. STUPAK. I think Mr. Burgess might have mentioned it. You

have mentioned it. It seems like we are aware of where these pill

mills are, but who would have the responsibility for controlling or

shutting them down?

Dr. TRESCOT. That is why I volunteered to be the expert witness

in this ongoing case, but this particular pill mill has been in existence since April. They have a physician who had never written—

sorry—controlled substances before who in September, from April

until September, had written at least 8,800 different prescriptions

for opioid narcotics, out of this one location.

Mr. STUPAK. So in order to write prescriptions you have to be licensed, so you have a State licensing agency, you have a law enforcement issue, and you have a public health issue, which

NASPER takes those components in consideration, but, with all

due respect to the Rogers Program, that is more oriented towards

law enforcement. Has that been your experience?

Dr. TRESCOT. Absolutely, and the problem comes in, is that there

is no way for me as a provider, you come into my office complaining

of low back pain. I have no test for pain, I have no ways of telling

by looking at you whether you are really hurting or not. So I have

two options. One is to consider you a potential drug abuser and

refuse you the pain medicines you might need. The other is to be

an enabler, to allow you to be able to scam me, just as you have

scammed other doctors in the community, by writing a medicine

because I believe you. So it immediately sets up an adversarial relationship. We feel that NASPER, because it was written to be

HIPAA compliant, requires a written consent from you to allow me

to access that data bank. Now obviously if you don’t give that consent, I don’t write the pain medicine.

Mr. STUPAK. Correct.

Dr. TRESCOT. So it is a quid pro quo. But in any case it allows

me to access the data bank to be able to see that you have not gotten medicines from any other prescribers, to be able to identify if

you are potentially in trouble, and intervene before your life is destroyed, and to then be able to establish a caring, open relationship

with you, to be able to give you the treatment that you deserve.

Mr. STUPAK. Two quick questions, if I may. Do you believe HHS

is the appropriate agency to run NASPER?

Dr. TRESCOT. I absolutely do. HHS is by definition involved with

healthcare. It allows a physician intervention at an early point, and

since the physician, as I said, is the end of the pen, the physician

is writing the prescription that is therefore getting abused. So it al-
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lows it to be done at a physician level. DOJ focuses on criminal activity, and I will be honest, for instance, in the Panhandle of Florida there have been some very egregious DOJ activities against

physicians, to the point that I have physicians telling me that they

feel that there are being attacked by, and the quote is ‘‘jack-booted

thugs’’. That has created an amazing chilling effect, so that patients come to me from the panhandle telling me that they do not

have the ability to get prescription medications in the panhandle,

and they have to come to Gainesville.

Mr. STUPAK. Quickly, any other States have a program real similar to NASPER? We have heard all kinds of figures——

Dr. TRESCOT. Yes. There are four.

Mr. STUPAK. Four?

Dr. TRESCOT. We have got Kentucky, Utah, Idaho, and Nevada.

Those are the only that allow physicians to have access to that information. Every other one denies physicians that ability.

Mr. STUPAK. Thank you. I am well over my time, but I want to

give you and Mr. Whitfield— questions please? Thank you again.

Mr. WHITFIELD. Dr. Trescot, we appreciate your being here very

much and thank you for the great job you are doing with the Association, and thank you for providing us with this magazine. And

now that we understand opiate pharmacology we can have a better

conversation with Dr. Burgess over there. But I am not going to

ask you any questions, and here is why. Your testimony is the kind

of testimony that we really needed when we were passing this legislation, and we had great testimony, and your testimony reaffirms

the necessity for this program. But unfortunately our problem right

now is getting the appropriations for it. So thank you very much

for being here and for your continued effort in this regard.

Mr. STUPAK. Thanks, Mr. Whitfield. I know you have been a

champion on this legislation, along with myself and others, and we

appreciate it, and we are going to get some money to get this thing

going. Mr. Burgess.

Mr. BURGESS. Thank you, Mr. Chairman. Thank you, Dr.

Trescot, for being here and sharing this information with us. You

referenced the Texas physician. Was that the same series of articles that I referenced in my opening statement?

Dr. TRESCOT. It is actually a different one.

Mr. BURGESS. Wow.

Dr. TRESCOT. This was on the CBS Evening News, was a physician’s assistant, actually, who would see the patients with no—they

had sent in undercover reporters with video, and it is all

videotaped and was presented, where he would come in, what

medicines do you want? There was no attempt at a physical exam,

no attempt at trying to obtain a history. The reporters were asked

at the window if they had records. They said, no. They said, fine.

That will be $150 or $200 or $80, whichever one it was at that particular time. They came into the room. They had a blood pressure

or weight taken, and then the physician’s assistant, describing himself as a doctor, came in and said, what do you need? They asked

for the medicines they wanted. The prescription was faxed over to

the pharmacy, and actually they got medicines that they didn’t

even ask for, and with four reporters that went in, they got over

700 tablets in four days of addictive substances.
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Mr. BURGESS. Are you familiar with the case that I referenced,

Dr. Maynard in south Dallas?

Dr. TRESCOT. Yes, sir, and it is very similar to the ones that we

are looking at in Florida and disgustingly similar unfortunately.

Mr. BURGESS. And even with all of the documentary evidence

that they brought up, this individual was given probation, and I

guess he lost his license. I don’t really know about that, but it

seems like it was pretty difficult to build the case and get—realistically, he was charged with, I think, 11 counts of murder and gets

probation. That is kind of phenomenal.

Dr. TRESCOT. And yet in the panhandle a doctor who was a

Board-Certified pain management physician, fellowship trained,

seeing 10 patients a day, not 100, had, I believe, two patients who

died. He was convicted and given 20 years in prison.

Mr. BURGESS. And that is actually what I was going to ask you

about, because that occurred, I think, before I took office here. As

a physician you worry about how to strike that right balance. You

obviously don’t want to bring the wrath of the DOJ down on your

neck, but at the same time you are in the treatment room with a

patient who is suffering, and your charge is to serve the suffering,

so it sets up a conflict that almost cannot be resolved.

Dr. TRESCOT. Except through NASPER, and that is what we

think is, with NASPER it allows us to be able to understand immediately whether or not that patient is drug seeking, whether or not

that patient is at risk for getting into trouble, and whether or not

it is a patient who is actually legitimate.

Mr. BURGESS. Now who would have access to the data in

NASPER?

Dr. TRESCOT. NASPER was written so that physicians who are

treating the patient, the pharmacists who are dispensing the medications, and law enforcement, only with the equivalent of a search

warrant, would have access to that information. And so it is protected information, only released to those people who have a reason

to need it.

Mr. BURGESS. What occurs in the instance where the prescribing

physician is the non-treating physician but covering for someone?

I mean, that is the situation where a drug-seeking behavior—I

mean, that would happen almost every weekend I was on call.

Someone randomly picks your name out of the phone book, say, I

am your partner’s patient, would you refill whatever? Either you

get tricked or you don’t, but how do you get permission from that

patient to access their database?

Dr. TRESCOT. And that is a very good question because that is

actually, in my practice we had the policy that, for no reason,

under any circumstances, were medications called in over the

weekend without the ability to review the chart, even though it

might have been one of my partners’ prescriptions. And when the

patients came in, they actually signed a sheet saying that they realized that, and if they had a problem and needed more medicines

they were required to go to the emergency room, putting an additional burden on our already overburdened emergency rooms. What

we visualize is that you could do the blanket consent that, so those

physicians who have a reason to have access, whether—it is an

agreement. If you have somebody who is covering you on call, you
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have an agreement with them for the exchange of that information,

and that consent would theoretically pass over.

Mr. BURGESS. Now, are you familiar with the Genetic Information Non-Discrimination Act that we just passed?

Dr. TRESCOT. No, I am not. I was very intrigued when you said

that, and I wasn’t familiar with it.

Mr. BURGESS. I guess arguably someone could say that the vulnerability to addictive behavior is an inherited trait, ergo it is a genetic condition, and we did put some pretty significant parameters

around the sharing of data. I do wonder if we have encroached

upon the turf of NAFTA with—oh, NAFTA—NASPER with this.

On the border State issue, Texas is a border State with another

country. What do we do in that situation? The trans-border migration in Texas is, of course, the stuff of legend on Lou Dobbs every

evening. It seems to me that this trafficking is probably just as

rampant as it is across the Georgia-Florida border, if not more.

Dr. TRESCOT. We can’t control the flow of bodies much less small

pieces of paper that are prescriptions or bottles of medication.

Ideally, you would end up with, I would think, a situation where

you could have an agreement with Mexico, but that is outside my

purview.

Mr. BURGESS. But many of these substances are not controlled

substances in Mexico, so Texas and California, New Mexico, and

Arizona would have a unique problem in that there may be the

flow of contraband essentially across their borders. Well, like Mr.

Whitfield, I appreciate so much the compilation of data. I think it

is going to be helpful going forward. I actually wish we had had

this when we had the GINA discussion, but that is an issue for another day. Mr. Chairman, I do hope we take on the Oxycontin

issue, because I think that is something that this committee should

look into, and I know there have been a lot of requests in that, and

I think it is something we should take up. And I will yield back.

Mr. STUPAK. Thank the gentleman. Doctor, thanks. Unfortunately we have to run to votes right now, but thanks for being

here. Thanks for sitting through the last panel, too. You did do

that, and we appreciate that.

Dr. TRESCOT. It was my pleasure, and thank you very much for

the invitation.

Mr. STUPAK. Thank you, and we will keep on this. We do have

our meeting tomorrow at 3:30 with Mr. Nussle, the Director of the

Office of Management and Budget, and maybe we can get this

funded in the President’s request next year.

Dr. TRESCOT. Well, the help of both of you has been greatly appreciated.

Mr. STUPAK. Thanks. That concludes our questioning. I want to

thank our witnesses for coming today and for their testimony. I ask

for unanimous consent that the hearing record will remain open for

30 days for additional questions for the record. Without objection,

the record will remain open. I ask unanimous consent that the contents of our document binder be entered in the record. Without objection, the documents will be entered in the record. That concludes

our hearing. With no objection, this meeting of the subcommittee

is adjourned. Thank you again.

[Whereupon, at 11:45 a.m., the subcommittee was adjourned.]
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[Material submitted for inclusion in the record follows:]
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