<DOC> [110th Congress House Hearings] [From the U.S. Government Printing Office via GPO Access] [DOCID: f:45316.wais] 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 U.S. GOVERNMENT PRINTING OFFICE 45-316 PDF WASHINGTON DC: 2008 --------------------------------------------------------------------- For Sale by the Superintendent of Documents, U.S. Government Printing Office Internet: bookstore.gpo.gov Phone: toll free (866) 512-1800; (202) 512ÿ091800 Fax: (202) 512ÿ092104 Mail: Stop IDCC, Washington, DC 20402ÿ090001 COMMITTEE ON ENERGY AND COMMERCE JOHN D. DINGELL, Michigan, Chairman HENRY A. WAXMAN, California JOE BARTON, Texas EDWARD J. MARKEY, Massachusetts Ranking Member RICK BOUCHER, Virginia RALPH M. HALL, Texas EDOLPHUS TOWNS, New York J. DENNIS HASTERT, Illinois FRANK PALLONE, Jr., New Jersey FRED UPTON, Michigan BART GORDON, Tennessee CLIFF STEARNS, Florida BOBBY L. RUSH, Illinois NATHAN DEAL, Georgia ANNA G. ESHOO, California ED WHITFIELD, Kentucky BART STUPAK, Michigan BARBARA CUBIN, Wyoming ELIOT L. ENGEL, New York JOHN SHIMKUS, Illinois ALBERT R. WYNN, Maryland HEATHER WILSON, New Mexico GENE GREEN, Texas JOHN B. SHADEGG, Arizona DIANA DeGETTE, Colorado CHARLES W. ``CHIP'' PICKERING, Vice Chairman Mississippi LOIS CAPPS, California VITO FOSSELLA, New York MICHAEL F. DOYLE, Pennsylvania STEVE BUYER, Indiana JANE HARMAN, California GEORGE RADANOVICH, California TOM ALLEN, Maine JOSEPH R. PITTS, Pennsylvania JAN SCHAKOWSKY, Illinois MARY BONO, California HILDA L. SOLIS, California GREG WALDEN, Oregon CHARLES A. GONZALEZ, Texas LEE TERRY, Nebraska JAY INSLEE, Washington MIKE FERGUSON, New Jersey TAMMY BALDWIN, Wisconsin MIKE ROGERS, Michigan MIKE ROSS, Arkansas SUE WILKINS MYRICK, North Carolina DARLENE HOOLEY, Oregon JOHN SULLIVAN, Oklahoma ANTHONY D. WEINER, New York TIM MURPHY, Pennsylvania JIM MATHESON, Utah MICHAEL C. BURGESS, Texas G.K. BUTTERFIELD, North Carolina MARSHA BLACKBURN, Tennessee CHARLIE MELANCON, Louisiana JOHN BARROW, Georgia BARON P. HILL, Indiana ______ 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) Subcommittee on Oversight and Investigations BART STUPAK, Michigan, Chairman DIANA DeGETTE, Colorado ED WHITFIELD, Kentucky CHARLIE MELANCON, Louisiana Ranking Member Vice Chairman GREG WALDEN, Oregon HENRY A. WAXMAN, California MIKE FERGUSON, New Jersey GENE GREEN, Texas TIM MURPHY, Pennsylvania MIKE DOYLE, Pennsylvania MICHAEL C. BURGESS, Texas JAN SCHAKOWSKY, Illinois MARSHA BLACKBURN, Tennessee JAY INSLEE, Washington JOE BARTON, Texas (ex officio) JOHN D. DINGELL, Michigan (ex officio) 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 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 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 over-prescribed 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 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 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 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. Thank you, again, Chairman Stupak and Ranking Member Whitfield. I yield back the balance of my time. ---------- I1 1/ 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. 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. 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 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 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 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? 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 9th- and 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:] 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 opening 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 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 middle-aged 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. 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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 non-medically in the 12 months prior to the survey. 2006, 2.1 percent of persons age 12 and older used a prescription pain reliever non-medically 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 education, 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:] [GRAPHIC] [TIFF OMITTED] T5316.021 [GRAPHIC] [TIFF OMITTED] T5316.022 [GRAPHIC] [TIFF OMITTED] T5316.023 [GRAPHIC] [TIFF OMITTED] T5316.024 [GRAPHIC] [TIFF OMITTED] T5316.025 [GRAPHIC] [TIFF OMITTED] T5316.026 [GRAPHIC] [TIFF OMITTED] T5316.027 [GRAPHIC] [TIFF OMITTED] T5316.028 [GRAPHIC] [TIFF OMITTED] T5316.029 [GRAPHIC] [TIFF OMITTED] T5316.030 [GRAPHIC] [TIFF OMITTED] T5316.031 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. 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. 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? 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 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 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 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. 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 higher 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 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 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? 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 prescription drug abuse. Unfortunately, the ONDCP's budget of $13 million doesn't include funding for NASPER, which is arguably the 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. 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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 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 allows 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. 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 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. 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