[House Hearing, 113 Congress] [From the U.S. Government Publishing Office] EXAMINING PUBLIC HEALTH LEGISLATION TO HELP LOCAL COMMUNITIES ======================================================================= HEARING BEFORE THE SUBCOMMITTEE ON HEALTH OF THE COMMITTEE ON ENERGY AND COMMERCE HOUSE OF REPRESENTATIVES ONE HUNDRED THIRTEENTH CONGRESS FIRST SESSION __________ NOVEMBER 20, 2013 __________ Serial No. 113-101 Printed for the use of the Committee on Energy and Commerce energycommerce.house.gov ______ U.S. GOVERNMENT PRINTING OFFICE 87-804 WASHINGTON : 2014 ____________________________________________________________________________ For sale by the Superintendent of Documents, U.S. Government Printing Office, http://bookstore.gpo.gov. For more information, contact the GPO Customer Contact Center, U.S. Government Printing Office. Phone 202�09512�091800, or 866�09512�091800 (toll-free). E-mail, [email protected]. COMMITTEE ON ENERGY AND COMMERCE FRED UPTON, Michigan Chairman RALPH M. HALL, Texas HENRY A. WAXMAN, California JOE BARTON, Texas Ranking Member Chairman Emeritus JOHN D. DINGELL, Michigan ED WHITFIELD, Kentucky FRANK PALLONE, Jr., New Jersey JOHN SHIMKUS, Illinois BOBBY L. RUSH, Illinois JOSEPH R. PITTS, Pennsylvania ANNA G. ESHOO, California GREG WALDEN, Oregon ELIOT L. ENGEL, New York LEE TERRY, Nebraska GENE GREEN, Texas MIKE ROGERS, Michigan DIANA DeGETTE, Colorado TIM MURPHY, Pennsylvania LOIS CAPPS, California MICHAEL C. BURGESS, Texas MICHAEL F. DOYLE, Pennsylvania MARSHA BLACKBURN, Tennessee JANICE D. SCHAKOWSKY, Illinois Vice Chairman JIM MATHESON, Utah PHIL GINGREY, Georgia G.K. BUTTERFIELD, North Carolina STEVE SCALISE, Louisiana JOHN BARROW, Georgia ROBERT E. LATTA, Ohio DORIS O. MATSUI, California CATHY McMORRIS RODGERS, Washington DONNA M. CHRISTENSEN, Virgin GREGG HARPER, Mississippi Islands LEONARD LANCE, New Jersey KATHY CASTOR, Florida BILL CASSIDY, Louisiana JOHN P. SARBANES, Maryland BRETT GUTHRIE, Kentucky JERRY McNERNEY, California PETE OLSON, Texas BRUCE L. BRALEY, Iowa DAVID B. McKINLEY, West Virginia PETER WELCH, Vermont CORY GARDNER, Colorado BEN RAY LUJAN, New Mexico MIKE POMPEO, Kansas PAUL TONKO, New York ADAM KINZINGER, Illinois JOHN A. YARMUTH, Kentucky H. MORGAN GRIFFITH, Virginia GUS M. BILIRAKIS, Florida BILL JOHNSON, Ohio BILLY LONG, Missouri RENEE L. ELLMERS, North Carolina 7_____ Subcommittee on Health JOSEPH R. PITTS, Pennsylvania Chairman MICHAEL C. BURGESS, Texas FRANK PALLONE, Jr., New Jersey Vice Chairman Ranking Member ED WHITFIELD, Kentucky JOHN D. DINGELL, Michigan JOHN SHIMKUS, Illinois ELIOT L. ENGEL, New York MIKE ROGERS, Michigan LOIS CAPPS, California TIM MURPHY, Pennsylvania JANICE D. SCHAKOWSKY, Illinois MARSHA BLACKBURN, Tennessee JIM MATHESON, Utah PHIL GINGREY, Georgia GENE GREEN, Texas CATHY McMORRIS RODGERS, Washington G.K. BUTTERFIELD, North Carolina LEONARD LANCE, New Jersey JOHN BARROW, Georgia BILL CASSIDY, Louisiana DONNA M. CHRISTENSEN, Virgin BRETT GUTHRIE, Kentucky Islands H. MORGAN GRIFFITH, Virginia KATHY CASTOR, Florida GUS M. BILIRAKIS, Florida JOHN P. SARBANES, Maryland RENEE L. ELLMERS, North Carolina HENRY A. WAXMAN, California (ex JOE BARTON, Texas officio) FRED UPTON, Michigan (ex officio) (ii) C O N T E N T S ---------- Page Hon. Joseph R. Pitts, a Representative in Congress from the Commonwealth of Pennsylvania, opening statement................ 1 Prepared statement........................................... 2 Hon. Tim Murphy, a Representative in Congress from the Commonwealth of Pennsylvania, opening statement................ 66 Hon. Kathy Castor, a Representative in Congress from the State of Florida, opening statement..................................... 67 Hon. John Shimkus, a Representative in Congress from the State of Illinois, opening statement.................................... 67 Hon. Marsha Blackburn, a Representative in Congress from the State of Tennessee, opening statement.......................... 67 Hon. Frank Pallone, Jr., a Representative in Congress from the State of New Jersey, opening statement......................... 68 Prepared statement........................................... 68 Hon. Ed Whitfield, a Representative in Congress from the Commonwealth of Kentucky, opening statement.................... 69 Hon. Henry A. Waxman, a Representative in Congress from the State of California, opening statement............................... 69 Prepared statement........................................... 70 Hon. Fred Upton, a Representative in Congress from the State of Michigan, prepared statement................................... 194 Witnesses Marsha Ford, President, American Association of Poison Control Centers........................................................ 90 Prepared statement........................................... 93 Answers to submitted questions............................... 196 Steven J. Stack, Immediate Past Chair, Board of Trustees, American Medical Association................................... 100 Prepared statement........................................... 102 Answers to submitted questions............................... 200 Drew Nagele, Board of Directors, Brain Injury Association of America........................................................ 107 Prepared statement........................................... 109 Edward R.B. McCabe, Senior Vice President and Chief Medical Officer, March of Dimes Foundation............................. 112 Prepared statement........................................... 114 Patricia V. Smith, President, Lyme Disease Association, Inc...... 120 Prepared statement........................................... 122 Laura Crandall, Program Director, Sudden Unexplained Death in Childhood Program.............................................. 130 Prepared statement........................................... 132 Robert MtJoy, Chief Executive Officer, Cornerstone Care, Inc..... 145 Prepared statement........................................... 147 Answers to submitted questions............................... 210 Submitted Material H.R. 1098, the Traumatic Brian Injury Reauthorization Act of 2013, submitted by Mr. Pitts................................... 3 H.R. 1281, the Newborn Screening Saves Lives Reauthorization Act of 2013, submitted by Mr. Pitts................................ 6 H.R. 610, A Bill to provide for the establishment of the Tick- Borne Diseases Advisory Committee, submitted by Mr. Pitts...... 19 H.R. 669, the Sudden Unexpected Death Data Enhancement and Awareness Act, submitted by Mr. Pitts.......................... 25 H.R. 2703, the Family Health Care Accessibility Act of 2013, submitted by Mr. Pitts......................................... 47 H.R. --------, the Poison Center Network Act, submitted by Mr. Pitts.......................................................... 53 H.R. --------, the National All Schedules Prescription Electronic Reporting Reauthorization Act of 2013, submitted by Mr. Pitts.. 58 Letter of November 20, 2013, from Carmen A. Catizone, Executive Director Secretary, National Association of Boards of Pharmacy, to Mr. Pitts and Mr. Pallone, submitted by Mr. Pitts........... 72 Statement, dated November 20, 2013, of the National Association of Chain Drug Stores, submitted by Mr. Pitts................... 75 Letter of November 19, 2013, from the National Organization for Injury and Violence Prevention to Mr. Upton and Mr. Waxman, submitted by Mr. Pitts......................................... 82 Letter of November 19, 2013, from Barbara E. Murray, President, Infectious Diseases Society of America, to Mr. Upton, et al., submitted by Mr. Pitts......................................... 84 Letter of November 19, 2013, from Martha A. Roherty, Executive Director, National Association of States United for Aging and Disabilities, to Mr. Upton and Mr. Waxman, submitted by Mr. Pitts.......................................................... 86 Letter of November 20, 2013, from the Alliance to Prevent the Abuse of Medicines to Mr. Whitfield, submitted by Mr. Pitts.... 88 Letters of endorsement, dated February 28 through November 20, 2013, submitted by Mr. Pallone................................. 156 Statement of Hon. Bill Pascrell, Jr., a Representative in Congress from the State of New Jersey, dated November 20, 2013, submitted by Mr. Pallone....................................... 184 EXAMINING PUBLIC HEALTH LEGISLATION TO HELP LOCAL COMMUNITIES ---------- WEDNESDAY, NOVEMBER 20, 2013 House of Representatives, Subcommittee on Health, Committee on Energy and Commerce, Washington, DC. The subcommittee met, pursuant to call, at 3:00 p.m., in room 2123, Rayburn House Office Building, Hon. Joseph R. Pitts (chairman of the subcommittee) presiding. Members present: Representatives Pitts, Burgess, Whitfield, Shimkus, Murphy, Blackburn, Lance, Griffith, Bilirakis, Pallone, Green, Barrow, Castor, and Waxman (ex officio). Staff present: Noelle Clemente, Press Secretary; Brenda Destro, Professional Staff Member, Health; Brad Grantz, Policy Coordinator, Oversight and Investigations; Sydne Harwick, Legislative Clerk; Katie Novaria, Legislative Clerk; Andrew Powaleny, Deputy Press Secretary; Chris Sarley, Policy Coordinator, Environment and the Economy; Heidi Stirrup, Policy Coordinator, Health; Ziky Ababiya, Democratic Staff Assistant; Elizabeth Letter, Democratic Assistant Press Secretary; and Anne Morris Reid, Democratic Professional Staff Member. Mr. Pitts. Thank you for your patience. I ask all guests please take their seats. The subcommittee will come to order. The Chair will recognize himself for an opening statement. OPENING STATEMENT OF HON. JOSEPH R. PITTS, A REPRESENTATIVE IN CONGRESS FROM THE COMMONWEALTH OF PENNSYLVANIA Today's legislative hearing examines seven important bipartisan public health bills aimed at improving the health of our families and communities. They are H.R. 1098, the Traumatic Brain Injury Reauthorization Act of 2013 introduced by Representative Bill Pascrell, which reauthorizes programs at the Centers for Disease Control and Prevention, CDC, to reduce the incidents of traumatic brain injury, TBI, and TBI surveillance systems and registries; H.R. 1281, the Newborn Screening Saves Lives Reauthorization Act of 2013 introduced by Representative Lucille Roybal-Allard, which reauthorizes Federal programs that provide assistance to States to improve and expand their newborn screening programs; H.R. 610, a bill to provide for the establishment of the Tick-Borne Diseases Advisory Committee introduced by Representative Chris Smith to ensure interagency coordination and communications on these diseases; H.R. 669, the Sudden Unexpected Death Data Enhancement and Awareness Act, introduced by Ranking Member Pallone which provides for grants to help improve the understanding of sudden unexpected death; H.R. 2703, the Family Healthcare Accessibility Act of 2013 introduced by Representative Tim Murphy, which would provide Federal Tort Claims Act protection for health care professionals who volunteer their time at community health centers; H.R. 3527, the Poison Control Centers Reauthorization Act, a very well- crafted bill introduced by Representative Lee Terry and will reauthorize important activities related to poison control centers; and H.R. 3528, National All Schedules Prescription Electronic Reporting, NASPER, Reauthorization Act introduced by Representative Ed Whitfield, which will reauthorize the NASPER program to support State prescription drug monitoring programs. [The prepared statement of Mr. Pitts follows:] Prepared statement of Hon. Joseph R. Pitts The subcommittee will come to order. The Chair will recognize himself for an opening statement. Today's legislative hearing examines seven important, bipartisan public health bills aimed at improving the health of our families and communities. They are:H.R. 1098--the Traumatic Brain Injury Reauthorization Act of 2013, introduced by Rep. Bill Pascrell, which reauthorizes programs at the Centers for Disease Control and Prevention (CDC) to reduce the incidence of traumatic brain injury (TBI), and TBI surveillance systems and registries. H.R. 1281--the Newborn Screening Saves Lives Reauthorization Act of 2013, introduced by Rep. Lucille Roybal- Allard, which reauthorizes Federal programs that provide assistance to States to improve and expand their newborn screening programs. H.R. 610--a bill to provide for the establishment of the Tick-Borne Diseases Advisory Committee, introduced by Rep. Chris Smith to ensure interagency coordination and communication on these diseases. H.R. 669--the Sudden Unexpected Death Data Enhancement and Awareness Act, introduced by Ranking Member Pallone, which provides for grants to help improve the understanding of sudden unexpected death. H.R. 2703--the Family Health Care Accessibility Act of 2013, introduced by Rep. Tim Murphy, which would provide Federal Torts Claim Act protection for health care professionals who volunteer their time at community health centers. H.R. ----, the Poison Control Centers Reauthorization, will be introduced by Rep. Lee Terry, and will reauthorize important activities related to poison control centers. And H.R. ----, National All Schedules Prescription Electronic Reporting (NASPER) Reauthorization Act, will be introduced by Rep. Ed Whitfield, will reauthorize the NASPER program to support State prescription drug monitoring programs. I look forward to hearing from our witnesses, and I'd like to yield time to some of the sponsors of these bills. 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I look forward to hearing from all of our witnesses, and I would like to yield the balance of my time to Dr. Murphy from Pennsylvania. OPENING STATEMENT OF HON. TIM MURPHY, A REPRESENTATIVE IN CONGRESS FROM THE COMMONWEALTH OF PENNSYLVANIA Mr. Murphy. Thank you, Mr. Chairman. Health centers are quality low cost medical homes for millions, but they are more than just doctor's offices. They are a place where a child sees a pediatrician and an adult gets a checkup from their internist, someone can see the dentist or receive mental health care or prenatal care. Together, medical professionals at health centers coordinate care and work as a team saving nearly $25 billion each year, money that would otherwise be spent on caring for sicker patients in emergency rooms. That is the good news. But the sad news is there is a serious shortage of providers, and no matter how great the center, families can experience long delays because of the shortage. Health centers located in medically underserved urban or rural areas report a 27 percent shortage of dentists, a 26 percent shortage of OB/GYNs, a 13 percent shortage of family physicians, and there are also shortages of psychiatrists and psychologists. The centers simply do not have enough money to hire additional staff required to cover the growing patient needs, but there is an answer. Part-time and semi-retired health professionals want to help out but are unable to volunteer because of Federal barriers. Oddly enough, at Federal free clinics, volunteer providers receive medical malpractice coverage by the Federal Torts Claim Act. On the other hand, doctors and professionals employed by health centers are covered by the Federal Torts Claim Act, but volunteers at health centers don't get that liability protection, which then costs the centers thousands of dollars, and in some cases, well over 100,000 per year for these extra doctors. Clinics cannot afford that extra expense. The Government Accountability Office has found that medical liability insurance costs poses a significant barrier for providers who otherwise would be eager to volunteer at health centers. The Family Health Care Accessibility Act fixes this disparity and opens the door for volunteer providers at clinics all over the country. I want thank Chairman Pitts and Chairman Upton for holding this hearing, and my partner, a friend of this legislation, Gene Green of Texas. I also want to thank Bob MtJoy of Cornerstone Care in Washington, Greene County, for being here today to testify about the potential for this legislation to help millions of families. We have a chance to do something to expand care to millions of Americans with this act without raising the bills for families or taxpayers. This is an example of real bipartisan reform that helps people get the health care they need, when they need it close to home at an affordable cost. Isn't that what we all want in health care? Thank you, and I yield back. Mr. Pitts. The Chair thanks the gentleman. Now yields 5 minutes to the lady from Florida, Ms. Castor, filling in for Ranking Member Pallone. OPENING STATEMENT OF HON. KATHY CASTOR, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF FLORIDA Ms. Castor. Well, thank you very much, Mr. Chairman, for calling this hearing today examining public health legislation to help our local communities. We are grateful to the public health experts, who we will hear from today, and I would also like to commend many of my colleagues who have offered legislation to combat some of the most serious public health problems facing many of our families all across this country, particularly when it comes to health centers, when it comes to newborn screening, poison control, and the terrible problem I am going to talk about a little bit later of pill mills and how we monitor the prescription drug abuse. So, thank you again, and at this time I am happy to yield to Mr. Waxman. Otherwise, he could take a full 5 minutes if he would like. Mr. Waxman. I am going to wait till my turn. Ms. Castor. OK. Then I will yield back. Thank you. Mr. Pitts. The Chair recognizes the gentleman from Illinois, Mr. Shimkus, for 5 minutes. OPENING STATEMENT OF HON. JOHN SHIMKUS, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF ILLINOIS Mr. Shimkus. Thank you, Mr. Chairman. My job is really to stall for Mr. Whitfield to get here, but since--that is a joke, so. It is good to have you-all here. What I--we get a lot of health care providers come to talk with us on public policy all the time, and what I always ask them in the end when they leave is to help us on the budgetary debate because we can authorize all we want, but if we don't solve or major budgetary problem, the discretionary budget keeps shrinking, which means less appropriations for the authorized committee, so you-all could help. I am not asking you to lobby, but I do ask you to get a good understanding of our real budgetary problems here and help us in that discourse. Mr. Chairman, there is also another bill that I am not trying to put pressure, but I just want you to put on your record. It is H.R. 1252. We have got 90 cosponsors. It is called, ``The Access to Care in Rural Communities,'' and it is really about physical therapy being defined within the primary health service for the purpose of the Health Services Corporation, and if you would take a look at that, that is bipartisan, and as we are talking about other bills that can be very helpful, I think that would be helpful for rural America. And with that, I would offer to the--Marsha Blackburn for as much time as she may consume. OPENING STATEMENT OF HON. MARSHA BLACKBURN, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF TENNESSEE Mrs. Blackburn. I thank the gentleman from Illinois for yielding, and I just want to welcome each of you and to commend you for the work that you do and the role that you play, not only in delivering health care services but in the education component that is so vitally important to so many health care consumers, especially young moms, those that have experienced traumatic injury. It is something that many times we do not put enough emphasis upon, and I appreciate that many of you are dedicated to that as a part of your core mission. With that, I yield back to the gentleman. Mr. Shimkus. The gentlelady yields, and I yield back to you, Mr. Pitts. Mr. Pitts. Would you yield to Mr. Pallone, please? Mr. Shimkus. I would be honored to yield to the ranking member of the subcommittee. OPENING STATEMENT OF HON. FRANK PALLONE, JR., A REPRESENTATIVE IN CONGRESS FROM THE STATE OF NEW JERSEY Mr. Pallone. Thank you. I am not going to take up time because I know that Ms. Castor spoke on behalf of the Democrats, but I just wanted to thank--well, I should say a very special welcome to Laura Crandall from New Jersey. She and I have worked together for many years on the bill, my bill that is before the subcommittee today, and I just want to say that your strength and determination is commendable, so thank you. Thank you, Mr. Chairman. [The prepared statement of Mr. Pallone follows:] Prepared statement of Hon. Frank Pallone, Jr. Thank you, Chairman Pitts, and thank you to our witnesses for being here today; a very special welcome to Laura Crandall from New Jersey. She and I have worked together for many years on my bill that is before the subcommittee today. Your strength and determination is commendable. I am happy that the subcommittee is having this hearing and moving forward with several public health bills. It is an important function of this subcommittee to examine public health priorities and to move legislation to promote and protect the public health. I would like to say a few words about each of the seven bills before us today. Firstly, I am particularly pleased that we will be examining a bill that I introduced, H.R. 669, the Sudden Unexpected Death Data Enhancement and Awareness Act. Stillbirth and sudden unexpected infant death affect tens of thousands of families every year, according to data from CDC, and sudden infant death syndrome is the leading cause of death for infants up to 12months old. However, we currently lack the comprehensive, high-quality data we need to help better understand this problem. My bill seeks to enhance CDC's activities in this area and would expand and standardize surveillance and data collection for stillbirth and sudden unexpected infant death and develop protocols and training for medical examiners for investigating these tragic deaths. I would like to submit for the record endorsement letters from 24 organizations, including the CJ Foundation, the American Academy of Pediatrics, and First Candle. I am proud to be a cosponsor of another bill we will examine today. H.R. 1098, the Traumatic Brain Injury Reauthorization Act of 2013, was authored by my friend and colleague from New Jersey, Mr. Pascrell. Traumatic brain injury (or ``TBI'') has been dubbed ``the silent epidemic,'' with at least 1.7 million TBI's occurring every year in the United States, manycausing death or permanent disability. This bill would continue efforts to advance better surveillance, prevention, and treatment of this serious public health problem. We will also cover today, the Newborn Screening Saves Lives Reauthorization Act of 2013, which would update the 2008 law that established national newborn screening guidelines by expanding and improving State screening programs, parent and provider education, and follow-up care. Newborn screening allows thousands of infants every year the chance to recognize and manage detectable conditions early on, and it improves their chances of a more positive health outcome and better quality of life. We will also hear from our witnesses on H.R. 610, a bill that would establish a Tick-Borne Diseases Advisory Committee within the Office of the Secretary of Health and Human Services to prioritize and coordinate efforts to address tick-borne diseases like Lyme disease. CDC estimates there are 300,000 cased of Lyme disease every year, and it is my understanding thatLyme disease is a growing threat in the United States, due to ecological changes and changes in land use over the past few decades that have increased the number and proximity to humans of wild animal Lyme hosts and the ticks that can spread it to humans. The fifth bill we will look at today is H.R. 2703, the Family Health Care Accessibility Act of 2013, which would decrease barriers to healthcare professionals volunteering at community health centers (or ``CHCs''). CHCs provide vital access to care, especially for those underserved and vulnerable populations who can benefit most from the comprehensive, quality primarycare services these centers provide. For the over 22 million patients currently served by CHCs, it is important that these centers are adequately staffed. Another bill we will consider today would reauthorize the poison control center grant program. I understand that poison exposure is a leading cause of unintentional injury in the United States, and poison control centers help to reduce the number of deaths and the severity of illness caused by poisoning. Finally, I am glad that we are considering the National All Schedules Prescription Electronic Reporting (or ``NASPER'') Reauthorization, which I coauthored with my colleague from Kentucky, Mr. Whitfield. This legislation helps States set up prescription drug monitoring programs in order to combat prescription drug abuse, which is a growing epidemic in the United States. It is critical that we continue support for this program through Federal funding. Thank you to the many Members who have led these important efforts by introducing these bills. I look forward to hearing from our witnesses on these important public health issues. Thank you. Mr. Pitts. The Chair---- Mr. Shimkus. I am reclaiming my time. Now I would like to recognize Mr. Whitfield from the great State of Kentucky for the remainder of the time. Mr. Pitts. All right. Two minutes. OPENING STATEMENT OF HON. ED WHITFIELD, A REPRESENTATIVE IN CONGRESS FROM THE COMMONWEALTH OF KENTUCKY Mr. Whitfield. Thank you very much. I appreciate it so much. And Chairman Pitts, I want to thank you for holding this hearing on this important topic, including H.R. 3528, the NASPER reauthorization as part of the discussion today. I would like to thank our witnesses for being here, particularly Dr. Steven Stack, a fellow Kentuckian from Lexington who will be testifying about the importance of prescription drug monitoring programs. As you know, NASPER was authorized some years ago, we have always had a battle like a lot of other programs in obtaining sufficient money to make NASPER be what it should be. There is a companion program over at the Department of Justice, prescription drug monitoring, but it is more focused on law enforcement. So, I want to thank the chairman very much for working with us on this reauthorization and look forward to the testimony of the witnesses today. And Mr. Shimkus, thank you so much for yielding me the time. Mr. Shimkus. And I yield back, Mr. Chairman. Mr. Pitts. The Chair thanks the gentleman. I now recognize the ranking member of the full committee, Mr. Waxman, 5 minutes for opening statement. OPENING STATEMENT OF HON. HENRY A. WAXMAN, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF CALIFORNIA Mr. Waxman. Thank you very much, Mr. Chairman. I appreciate you holding this hearing. These bipartisan bills strengthen Department of Health and Human Services programs on addressing new public health challenges. It is critical that this committee continues its focus on public health issues since our actions in the public health arena have such a far-reaching effect on the Nation's health. We have a number of bills. H.R. 610 deals with the Lyme and other tick-borne diseases. There is the Sudden Unexpected Death Data Enhancement and Awareness Act. We have the H.R. 1098, Traumatic Brain Injury Reauthorization, and we have, also considering H.R. 1281, the Newborn Screening Saving Lives Reauthorization Act, the Family Health Care Accessibility Act of 2013 allowing community health centers to offer malpractice insurance coverage to their employees, contractors, and officers with the--under the Federal Tort Claim Act; H.R. 3527, the Poison Center Network Act, which reauthorizes the Poison Control Program; and then H.R. 3528, the National All Schedules Prescription Electronic Reporting Act--Reauthorization Act of 2013. I have longer statements about each of these, which I will put into the record, but I want to commend a Democratic and Republican Energy and Commerce Committee members and their staffs who have authorized a number of the bills before us, Mr. Pallone, Mr. Engel, Green, Whitfield, Terry, and Murphy, and acknowledge the sponsors of the other measures, Congresswoman Roybal-Allard, Congressman Pascrell, Congressman Smith. We have a panel of stakeholders to share their views on these bills, and I want to thank each of you for--in advance for your testimony. I don't want to be parochial, but Dr. McCabe was from California, but wherever you are from, we have a national perspective to protect the public health, and so I want to welcome all of you here today. Mr. Chairman, I also hope we can work together on getting the administration's input on each of these measures as they move forward. With those comments, I will yield back the balance of my time. [The prepared statement of Mr. Waxman follows:] Prepared statement of Hon. Henry A. Waxman Mr. Chairman, thank you for convening this afternoon's hearing on bipartisan bills that strengthen existing Department of Health and Human Services programs or address new public health challenges. It is critical that this committee continues its focus on public health issues, since our actions in the public health arena have such a far-reaching effect on the Nation's health. H.R. 610 would establish a committee to advise the Secretary of HHS on the Department's Lyme and other tick-borne disease activities. The Centers for Disease Control and Prevention reports there has been a reemergence of tick-borne disease--with hundreds of thousands of estimated annual Lyme disease cases alone. The Sudden Unexpected Death Data Enhancement and Awareness Act or H.R. 669 addresses three, devastating health events-- stillbirth, the unexpected loss of an infant, and the unexpected death of a child. Thousands of expectant mothers and parents experience a later-stage pregnancy loss or death of an infant due to causes that are not immediately apparent. Less is known about the unexplained deaths of young kids, like the daughter of one of today's witnesses--Ms. Crandall. H.R. 669 seeks to improve our understanding of the causes of these tragic events--and, in turn, help us to better prevent them. H.R. 1098 or the Traumatic Brain Injury Reauthorization Act of 2013 extends TBI surveillance and research activities, and programs for services and supports administered across the Department. Millions of Americans experience a traumatic brain injury each year. One goal of H.R. 1098 is to allow the Department to better coordinate TBI activities with other HHS programs focused on increased access to community supports. We are also considering H.R. 1281, the Newborn Screening Saves Lives Reauthorization Act of 2013. This legislation extends newborn screening services and related activities forconditions like sickle cell anemia--that are not otherwise apparent at birth and, if left untreated, can cause severe disability or even death. The Family Health Care Accessibility Act of 2013, H.R. 2073, would allow community health centers to offer malpractice coverage available to their employees, contractors, and officers under the Federal Tort Claims Act to health practitioner volunteers. In doing so, H.R. 2073 seeks to eliminate possible disincentives for health practitioners to volunteer. The House passed similar legislation during the 111th Congress. H.R. 3527 or the Poison Center Network Act reauthorizes the Poison Control Program. Federal funding for the Nation's poison control centers supports the provision of treatment advice on poisonings to health professionals and the public; educational activities; and poison exposure surveillance efforts. The poison control network plays an important role in reducing the number of injuries and deaths resulting from poisoning and overdose The final bill is H.R. 3528, the National All Schedules Prescription Electronic Reporting Reauthorization Act of 2013, a second measure related to overdose. The NASPER Reauthorization Act would extend the Department's prescription drug monitoring program first authorized in 2005 and strengthen the interoperability of State NASPER programs. During a June subcommittee hearing, witnesses described how programs like this one help respond to the prescription drug overdose epidemic. Congress also passed legislation nearly identical to H.R. 3528 during the 111th Congress. I want to commend the Democratic and Republican Energy and Commerce Members who authored a number of the bills before us--Ranking Member Pallone and Congressmen Engel, Green, Whitfield, Terry, and Murphy. I'd also like to acknowledge the sponsors of the other measures--Congresswoman Roybal-Allard, Congressman Pascrell, and Congressman Smith. We have a panel of stakeholders to share their views on these bills, and I want to thank each of the witnesses in advance for their testimony. Mr. Chairman, I also hope that we can work together on getting the administration's input on each of these measures as they move forward. Mr. Pitts. The Chair thanks the gentleman. We will work with you, and I would like to seek unanimous consent at this time to enter six documents into the record. First, a letter from the National Association of Boards of Pharmacy; second, statement from the National Association of Chain Drug Stores; thirdly, a letter from the National Organization for Injury and Violence Prevention; fourthly, letter from the Infectious Diseases Society of America; fifth, letter from National Association for States United for Aging and Disabilities; and sixth, a letter from the Alliance to Prevent Abuse of Medicines. Without objection, so ordered. They will be entered into the record. [The information follows:] [GRAPHIC] [TIFF OMITTED] T7804.064 [GRAPHIC] [TIFF OMITTED] T7804.065 [GRAPHIC] [TIFF OMITTED] T7804.066 [GRAPHIC] [TIFF OMITTED] T7804.067 [GRAPHIC] [TIFF OMITTED] T7804.068 [GRAPHIC] [TIFF OMITTED] T7804.069 [GRAPHIC] [TIFF OMITTED] T7804.070 [GRAPHIC] [TIFF OMITTED] T7804.071 [GRAPHIC] [TIFF OMITTED] T7804.072 [GRAPHIC] [TIFF OMITTED] T7804.073 [GRAPHIC] [TIFF OMITTED] T7804.074 [GRAPHIC] [TIFF OMITTED] T7804.075 [GRAPHIC] [TIFF OMITTED] T7804.076 [GRAPHIC] [TIFF OMITTED] T7804.077 [GRAPHIC] [TIFF OMITTED] T7804.078 [GRAPHIC] [TIFF OMITTED] T7804.079 [GRAPHIC] [TIFF OMITTED] T7804.080 [GRAPHIC] [TIFF OMITTED] T7804.081 Mr. Pitts. On our panel today we have introduce them at this time. Dr. Marsha Ford, president of the American Association of Poison Control Centers; Dr. Steven Stack, immediate past chair, Board of Trustees, American Medical Association; Dr. Drew Nagele, Board of Directors, Brain Injury Association of America; Dr. Edward McCabe, senior vice president, Chief Medical Officer of the Office of Medicine and Health Promotion, March of Dimes Foundation; Ms. Patricia Smith, president of the Lyme Disease Association; Ms. Laura Crandall, cofounder of Sudden Unexplained Death in Childhood Program; and finally, Mr. Robert MtJoy, CEO of Cornerstone Care. I thank each of you for coming. Your prepared testimonies, written testimony will be placed in the record. You will each have 5 minutes to summarize your testimony, and so at this time, the Chair recognizes Dr. Ford for 5 minutes for a summary of her opening statement. STATEMENTS OF MARSHA FORD, PRESIDENT, AMERICAN ASSOCIATION OF POISON CONTROL CENTERS; STEVEN J. STACK, IMMEDIATE PAST CHAIR, BOARD OF TRUSTEES, AMERICAN MEDICAL ASSOCIATION; DREW NAGELE, BOARD OF DIRECTORS, BRAIN INJURY ASSOCIATION OF AMERICA; EDWARD R.B. MCCABE, SENIOR VICE PRESIDENT AND CHIEF MEDICAL OFFICER, MARCH OF DIMES FOUNDATION; PATRICIA V. SMITH, PRESIDENT, LYME DISEASE ASSOCIATION, INC.; LAURA CRANDALL, PROGRAM DIRECTOR, SUDDEN UNEXPLAINED DEATH IN CHILDHOOD PROGRAM; AND ROBERT MTJOY, CHIEF EXECUTIVE OFFICER, CORNERSTONE CARE, INC. STATEMENT OF MARSHA FORD Ms. Ford. Thank you. Chairman Pitts, Ranking Member Pallone, and members of the subcommittee, I appreciate the opportunity to testify today in support of the reauthorization of the National Poison Center Program entitled ``America's Poison Center Network Act.'' I am Dr. Marsha Ford, director of the Carolina's Poison Center In Charlotte, North Carolina and president of the American Association of Poison Control Centers, otherwise known as the AAPCC. The AAPCC is comprised of 56 regional poison centers that serve 100 percent of the population of the United States providing 24/7 real-time case triage and management advice for diverse multitude of poisoning problems. I am pleased to have join me today Kathy Jacobitz, who is director of the Nebraska Regional Poison Center in Omaha, Nebraska, and John Fiegel, the interim executive director of the AAPCC. And on behalf of all AAPCC member centers, I wish to express our appreciation to Mr. Terry and Mr. Engel and to the very talented health staff, including respectably, Nick Magallenes and Heidi Ross for their leadership in helping craft this bipartisan reauthorization legislation. The National Poison Center network legislation was first passed in Congress in 2000 and has been reauthorized twice. It is a highly successful truly public-private Federal, State, local partnership. It reduces unnecessary hospital visits, hospitalizations, and health care cost in our country by 1.8 billion annually, according to the 2012 Lewin Group cost- benefit study and as restated in HRSA's annual report to Congress earlier this year. The Poison Center Program is currently authorized through Public Law 110-377, the Poison Center Support, Enhancement, and Awareness Act of 2008. This program is legislatively mandated to do three things: Supply funding to support operations of poison centers, establish and maintain a single national toll- free number, and implement a nationwide media campaign to educate the public and health care providers about poison prevention, poison center services, and the toll-free number. These three essential components comprise what is being requested for funding in this reauthorization bill. What key services do poison centers provide? I will briefly describe four: First, we provide assistance in triaging, diagnosing, and managing victims of a multitude of toxic exposures and public health emergency situations. We do this for the public, for health care providers, for emergency response personnel, and others. We do this for all people, including underserved and vulnerable populations. We do this for all ages and all types of problems. We do this for physicians and other health care providers who increasingly utilize poison centers for toxicological expertise. Emergency 911 dispatchers refer poison-related calls to poison centers, often avoiding unnecessary EMS transports. Altogether, in 2012, the Nation's poison centers handled nearly 3.4 million cases and made 2.7 million follow-up calls to ascertain the status of the caller or the patient. And we do this at no cost to the caller. Poisoning is a major public health problem and is now the leading cause of injury death in the United States, having surpassed motor vehicular deaths. Poisonings are expensive. In 2009, an estimated 4.4 billion was spent on health care for poisoned patients. Poison centers are an antidote for some of the spending. In 2011, use of the Nation's poison centers avoided an estimated 1.7 million unnecessary health care visits and decreased hospital lengths of stay for some patients. A second function of poison centers is the collection of poison exposure and disease surveillance data. Multiple Federal agencies use this data for surveillance to identify, characterize, and track public health threats. One example, early recognition of the toxicity of unit dose, laundry detergent packets in small children. In a great sense of timing, The Wall Street Journal had a front page article about this in yesterday's paper. Poison centers also provide case triage and management advice in specific public health events. Something I am very excited about, the AAPCC and its member centers are working with the CDC to design a coordinated national network that will provide telemedicine services during a severe influenza pandemic to triage cases and selectively provide anti-virile medications, thus reducing medical surge on health care facilities and allowing more appropriate use of these medical resources. Once created, this network may be capable of providing services during other public health emergencies. A third function, poison centers provide poisoning prevention education to the public and clinical education to health care providers. And finally, a fourth function, participation in emergency preparedness. The surveillance system that I mentioned earlier enables detection and monitoring of public health and environmental emergencies involving toxic exposures and pandemics. The value of poison centers has been demonstrated in national emergencies such as the Gulf Oil spill, the H1N1 outbreak, and the Fukushima Nuclear Accident. Medical toxicologists from poison centers assist the Department of Homeland Security with risk assessment of chemical threats. Tens of millions of American families and tens of thousands of health care professionals have used poison centers services, experiencing firsthand the value of the Nation's poison center network. Thank you again for this opportunity to highlight the value and importance of the National Poison Center Program. The Nation's poison centers, your poison centers strongly support the proposed Terry-Engel reauthorization legislation of the poison center program that is before the subcommittee today. Thank you. Mr. Pitts. The Chair thanks the gentlelady. [The prepared statement of Ms. Ford follows:] [GRAPHIC] [TIFF OMITTED] T7804.082 [GRAPHIC] [TIFF OMITTED] T7804.083 [GRAPHIC] [TIFF OMITTED] T7804.084 [GRAPHIC] [TIFF OMITTED] T7804.085 [GRAPHIC] [TIFF OMITTED] T7804.086 [GRAPHIC] [TIFF OMITTED] T7804.087 [GRAPHIC] [TIFF OMITTED] T7804.088 Mr. Pitts. I now recognize Dr. Stack, 5 minutes for an opening statement summary. STATEMENT OF STEVEN J. STACK Mr. Stack. Thank you, Mr. Chairman. My name is Steven Stack, an emergency physician from Lexington, Kentucky, and the immediate past chairman of the board of trustees of the American Medical Association. To begin, thank you, Chairman Pitts, Ranking Member Pallone, and members for convening to examine public health legislation to help local communities. The AMA appreciates the opportunity to provide our views on H.R. 3528, the National All Schedules Prescription Electronic Reporting Reauthorization Act of 2013. Reauthorization and full appropriations for NASPER are urgently needed to ensure that physicians across our Nation have this critical tool to combat the scourge of prescription drug abuse while ensuring that patients in pain are relieved of their suffering. The personal and economic costs of prescription drug abuse far outweigh the annual appropriations of H.R. 3528. One study puts the potential overall cost of prescription drug abuse at more than $70 billion a year. The escalating cost of diverted prescription drugs to the overall health care system and the financial impact to the rest of the economy are enormous. The human cost and personal tragedies that could be averted with the help of NASPER are no less profound. Since 2005, the AMA, along with many other health care stakeholders, have supported NASPER as an essential resource to combat prescription drug abuse and diversion. Unfortunately, the appropriations to fully fund, modernize, and optimize NASPER prescription drug monitoring programs, or PDMPs have not kept pace with the escalation in abuse and diversion. Physicians struggle firsthand with this epidemic and fully understand the human cost and toll it takes on families and entire communities. It is a formidable challenge. We have an ethical obligation to treat patients with pain, and also to identify inappropriate drug seekers in order to prevent abuse, overdose, and death. This is not easy. In fact, it is often downright difficult. Physicians face many barriers in their efforts to maintain a balance. The AMA agrees with other impacted stakeholders that this problem requires a multi-pronged coordinated strategy. We support robust implementation of a combination of Federal and State policies to address both the supply and demand side of this epidemic. Modernized and fully interoperable PDMPs are a key component of these efforts. Though nearly a decade has passed since NASPER was enacted, the full promise has not been achieved. In theory, PDMPs were to provide reliable and actionable clinical information to physicians in State public health agencies. In reality, although $60 million was authorized over a 5-year period, it was not until 2009 that Federal funds were appropriated under NASPER to support the State adoption of PDMPs. H.R. 3528 is urgently needed now. The vast majority of physicians still don't have access to reliable real-time information about controlled substance prescriptions patients have obtained and filled from other prescribers. In fact, it is only in the past couple of years that most States have finally passed legislation establishing PDMPs. Even now, the majority of PDMPs still are not real-time, interoperable, or available at the point of care as a regular part of physician workflow. In far too many States, PDMPs remain underfunded, understaffed, and technologically inadequate. Recent years, a financial belt tightening within States has led to anemic funding, and in some cases, defunding of PDMPs, even as this public health scourge ravages our communities. We must do better. To be helpful, it is essential that PDMPs are easy to use and provide reliable information to guide sound clinical decisions. When prescription drug monitoring programs support clinical decision making, the efficacy is remarkable. As a pilot, Ohio placed PDMPs in emergency departments and found that 41 percent of prescribers, given reliable PDMP data, altered their prescribing decisions. Accurate PDMP data can directly inform sound clinical decisions, thereby reducing diversion and abuse, while still ensuring that patients receive the care they need. The AMA is committed to combating prescription drug abuse and diversion. Further, we believe a public health focus is essential to achieve to successful and sustainable solutions. By working together, we can and will resolve this crisis. The AMA appreciates the opportunity to provide our views on the essential role of modernized PDMPs. Action is needed now. I implore you to urgently reauthorize and fully fund NASPER. Thank you. [The prepared statement of Mr. Stack follows:] [GRAPHIC] [TIFF OMITTED] T7804.089 [GRAPHIC] [TIFF OMITTED] T7804.090 [GRAPHIC] [TIFF OMITTED] T7804.091 [GRAPHIC] [TIFF OMITTED] T7804.092 [GRAPHIC] [TIFF OMITTED] T7804.093 Mr. Pitts. The Chair thanks the gentleman. Now recognizes Dr. Nagele for 5 minutes for an opening statement. STATEMENT OF DREW NAGELE Mr. Nagele. Chairman Pitts, Ranking Member Pallone, and members---- Mr. Pitts. Is your light on? Mr. Nagele. Yes. Mr. Pitts. Just make sure. OK. Pull it up. Mr. Nagele. And members of the Health Subcommittee, thank you for inviting me to testify on reauthorization of the Traumatic Brain Injury Act, H.R. 1098. My name is Dr. Drew Nagele. I am the executive director of Beechwood NeuroRehab, which serves clients from Pennsylvania, New Jersey, and Delaware. For over 30 years, I have worked with individuals who have brain injury and their families as a licensed psychologist. I serve on the board of the Brain Injury Association of America, and I am also testifying on behalf of the National Association of State Head Injury Administrators and the National Disability Rights Network. 2.4 million Americans of all ages, races, and income levels sustain TBIs each year. The injury can change the way a person can think, move, talk, feel, and act, and can increase the risk for other brain-related diseases and disorders. The TBI Act is a comprehensive law combining research, data collection, prevention, public awareness, consumer advocacy, and service system coordination for this vulnerable and growing population. The law authorizes NIH to conduct basic and applied research, and for CDC to conduct surveillance, prevention, and public education programs. The Health Resources and Services Administration makes grants to States and territories to develop or expand service system capacity based on the specific needs in each State. Currently, 20 States and territories are receiving these grant funds. Many States work to strengthen screening and identification methods among unserved or underserved persons with brain injury. In Pennsylvania, we are screening prison inmates and connecting them to services and supports when they are released from prison. Minnesota has instituted a similar program, and Virginia is screening its juvenile justice inmates. Several States use grant funds for TBI-specific training and professional development. In New Jersey, State grant funds were used to train members of the clergy. Grants allow States to coordinate and streamline TBI service systems. In Pennsylvania and Tennessee, we have linked hospitals and schools, and in Alabama we have improved Federal mechanisms for accessing existing services. Additional State grants have helped leverage resources in other Federal and State programs and nonprofit organizations. Michigan and West Virginia evaluated Medicaid utilization and then applied for home and community-based waivers that are tailored to the needs of individuals with brain injury and are more cost-effective for the State. By far, the most common use of State grants is assisting persons with brain injury and their families through outreach, information, education, service coordination, and resource facilitation. Arizona, Colorado, Idaho, Iowa, Indiana, Massachusetts, Michigan, Missouri, Nebraska, New York, Virginia, West Virginia, and Texas have all used TBI Act grants to outreach to children and youth, active duty military and veterans, Native Americans, older adults, multi-cultural families, and the thousands of civilians who fall through the cracks each year. The TBI Act also authorizes formula-funded grants to protection and advocacy organizations to ensure that people with TBI live full and independent lives. Known as PATBI, this programs helps people navigate complex service systems and investigates instances of abuse and neglect. Recently, the Disability Rights Network of Pennsylvania represented a client who has a TBI as a result of domestic violence and was being denied appropriate services by her service coordinator. Our P&A helped her change to a new service coordinator, and now she is getting the services she needs. In this reauthorization, BIAA, NASHIA, and NRDN all recommend the State grant program and the PATBI program be elevated within the Department of Health and Human Services, preferably the Administration for Community Living, to better integrate individuals with brain injury into HHS' aging and disability initiatives. Now, more than ever, it is imperative that we foster collaboration and maximize the limited resources at both the State and Federal levels. This can only be achieved if we work hand-in-hand with other aging and disability populations. The TBI stakeholders believe elevating the program to ACL is the best way to increase effectiveness and cost efficiency. Thank you. [The prepared statement of Mr. Nagele follows:] [GRAPHIC] [TIFF OMITTED] T7804.094 [GRAPHIC] [TIFF OMITTED] T7804.095 [GRAPHIC] [TIFF OMITTED] T7804.096 Mr. Pitts. The Chair thanks the gentleman. Now recognizes Dr. McCabe, 5 minutes for an opening statement. STATEMENT OF EDWARD R.B. MCCABE Mr. McCabe. Good afternoon, Chairman Pitts, Ranking Member Pallone, and members---- Mr. Pitts. Is your mic on? There you go. Mr. McCabe. Good afternoon. And thank you. My name is Dr. Edward McCabe, and I am senior vice president and chief medical officer for the March of Dimes Foundation, a unique partnership of scientists, clinicians, parents, and volunteers working to prevent birth detects, preterm birth, and infant mortality. I appreciate this opportunity to testify today on newborn screening, one of the great public health victories of the 20th Century and one which continues to save infants lives every day. Newborn screening is a critically important and highly effective public health program for testing every newborn for certain genetic, metabolic, hormonal, and functional conditions not authorize apparent at birth. Approximately one in every 300 newborns has a condition that can be detected through screening. Newborn screening detects conditions that, if left untreated, can cause disability, developmental delay, illness, and even death. If diagnosed early, many of these disorders can be managed successfully, which not only reduces the physical burden of disease but can also help to reduce the associated economic burden on families, communities, and the government. This year, our Nation is celebrating the 50th Anniversary of newborn screening. The March of Dimes is deeply proud of our decades' long history of funding research that has led or contributed to the development of numerous newborn screening tests. Together, these tests have allowed us to preserve the health and wellbeing of thousands of children. The remarkable progress of newborn screening over the past 2 decades persuaded Congress to pass a Newborn Screening Saves Lives Act in 2008. The law renewed and updated various programs that underpin States' newborn screening efforts as well as the Secretary's Advisory Committee on Heritable Disorders. That law expired at the end of fiscal year 2013 and is due for a 5-year renewal. Passage of the Newborn Screening Saves Lives Reauthorization Act is essential to the continued success of newborn screening programs across our Nation. Most importantly, reauthorization will ensure the uninterrupted continuation of the Secretary's Advisory Committee on Heritable Disorders and its work. Maintaining and updating the recommended uniform screening panel that States use to adopt and implement new conditions is vital and ongoing and planned evidence review should not be delayed. The Newborn Screening Saves Lives Reauthorization Act also extends important programs at HRSA, CDC, and NIH, including Seven Genetics and Newborn Screening Regional Collaborative Groups and the National Coordinating Center, which improves the availability, accountability, and quality of genetic services and resources for individuals with genetic conditions; the Critical Congenital Heart Disease Newborn Screening Demonstration product program, a program to support the development, dissemination, and validation of screening protocols and newborn screening infrastructure for point-of- care screening specific to congenital heart defects; Babies First Test, a national educational resource center for newborn screening, the Newborn Screening Technical Assistance and Evaluation Program, or NewSTEPs, which serves as a technical assistant program for State newborn screening systems; the Newborn Screening Quality Assurance Program, a comprehensive CDC program devoted to ensuring the accuracy of newborn screening; and the Hunter Kelly Research Program at the NIH, which supports grants and contracts to develop and improve technologies related to newborn screening. Today, 42 States and the District of Columbia require screening for at least 29 of the 31 treatable core conditions. Millions of babies have been screened for dozens of disorders, and in thousands of cases, the health and well-being of those children has been preserved. Newborn screening represents a model Federal-State public health partnership that has produced extraordinary improvements in child health. We must not allow this vital public health effort to falter. On behalf of over 3 million March of Dimes volunteers and countless other organizations and families, I urge the members of this subcommittee to cosponsor and support H.R. 1281, the Newborn Screening Saves Lives Act, and the committee to report the legislation this fall. We look forward to working closely with the committee and chamber leadership to ensure it can be passed as soon as possible by both the House and the Senate. Thank you for your attention to this vitally important child health issue. The March of Dimes stands ready to assist you in ensuring that newborn screening programs will continue to protect the health and well-being of newborns for many years to come. Thank you. Mr. Pitts. The Chair thanks the gentleman. [The statement of Mr. McCabe follows:] [GRAPHIC] [TIFF OMITTED] T7804.097 [GRAPHIC] [TIFF OMITTED] T7804.098 [GRAPHIC] [TIFF OMITTED] T7804.099 [GRAPHIC] [TIFF OMITTED] T7804.100 [GRAPHIC] [TIFF OMITTED] T7804.101 [GRAPHIC] [TIFF OMITTED] T7804.102 Mr. Pitts. Now recognize Ms. Smith, 5 minutes for an opening statement. STATEMENT OF PATRICIA V. SMITH Ms. Smith. Thank you, Mr. Chairman and committee members. I appreciate the opportunity to testify on the establishment of Lyme and Tick-Borne Diseases Advisory Committee. In 2009, the CDC indicated that Lyme surpassed HIV in incidents, and that was followed by a 2013 announcement confirming a 10-fold underreporting of Lyme cases, estimating 300,000 Lyme cases annually. A 2001 NIH-sponsored study found the impact of Lyme on physical health status was at least equal to the disability of patients with congestive heart failure or osteoarthritis and, was greater than those with type II diabetes or recent myocardial infarction. If you couple those facts with Lyme spreading worldwide now to 80 countries and the discovery of many new emerging tick-borne pathogens carried by many different ticks, then the passage of H.R. 610 is long overdue. Other tick-borne diseases in the U.S. include anaplasmosis, babesiosis, bartonellosis, ehrlichiosis, Rocky Mountain Spotted fever, Colorado tick fever, Q fever, tick paralysis, tularemia, Powassan encephalitis, STARI, which is a Lyme-like disease carried by a different tick, Rickettsia parkeri--parkeri, excuse me, Ricketsiosis found increasingly along the Gulf Coast and in the South, Borrelia miyamotoi, which was an organism that produced disease in Russia, the first cases, and now it has been found here, and Eschar-associated illness, Ricketsia species 364D in the Pacific region, and a newly-discovered tick-borne virus in Missouri called Heartland. So, my education on Lyme began almost 30 years ago as a New Jersey Board of Education member whose district had a large number of students and staff out with the disease. At that time, only a few ticks were recognized as major health threats to humans. Now the list includes Ixodes scapularis, which is the deer or black-legged tick you probably know, Amblyomma americanum, the lone start tick, Dermacentor variabilis, the American dog tick, Dermacentor andersoni, the Rocky Mountain wood tick, Ixodes pacificus, which is the western black-legged tick, Amblyomma maculatum, the Gulf Coast tick, and Dermacentor occidentalis, the Pacific Coast tick. Now, one tick bite can produce more that one disease at the same time. My Lyme work, including 17-plus years as president of the volunteer-run national nonprofit Lyme Disease Association keeps me in close contact with patients nationwide. Lyme's complexity and difficulty in diagnosis have exacerbated the plight of patients and their families, many of which contain more than one Lyme victim. Medical bills rise, jobs are lost, education is interrupted. Children are at the highest risk of acquiring Lyme, and based on CDC's Lyme reported case numbers from 2001 to 2010 by age, the LDA estimates 37 percent of reported cases were children. So, if you use 1990 through 2011 CDC reported numbers and you adjust that for the 10-fold underreporting, we then found that 1,599,000--excuse me, 1,590,499 children have developed Lyme over that time period, and unfortunately, there are probably more children that were diagnosed, but they weren't included in that CDC surveillance figure because that is a very narrow surveillance criteria not meant for clinical diagnosis. A 2001 Columbia study showed children with Lyme had significantly more psychiatric disturbances and cognitive deficits, even after they were controlled for anxiety, depreciation, and fatigue. So Lyme in children may be accompanied by long-term neuropsychiatric disturbances resulting in psycho, social, and academic impairment. Parents indicated 41 percent of children had suicidal thoughts. 11 percent had made a suicide gesture. Early intervention and appropriate treatment are the answers for Lyme patients to prevent development of chronic disease, also known as Post Treatment Lyme Disease, late disseminated Lyme disease, persistent Lyme, Post Lyme Disease Syndrome, et cetera. The discussions continue on the justification for various terms for chronic Lyme, but we can't allow semantics to eclipse the need for research on chronic Lyme, the area producing the most human suffering, but yet it is receiving the least research funding. According to a new Columbia study, based upon the 10-fold underreporting and 10 percent of newly infected and treated patients developing symptoms, which persist for more than 6 months, the actual incidents of new chronic Lyme cases, which they call Post Treatment Lyme Syndrome, is 30,000 annually for chronic Lyme development. Many major health threats, including chronic fatigue, have an advisory committee. Lyme doesn't, placing patients and advocates at a great disadvantage. We have lobbied for a research agenda, which includes more effective treatments that are diagnostic, including detection of active infection. Borellia Burgdorferi was recognized to cause Lyme almost 33 years ago, yet the two-tier testing system endorsed by CDC, though it is very specific for Lyme, 99 percent and gives few false positives, the tests have a uniform low sensitivity, 56 percent, meaning 88 out of 200 patients with Lyme are missed. Mr. Pitts. Summarize, please. Ms. Smith. Excuse me? Mr. Pitts. Your time has expired. Could you summarize? Ms. Smith. Oh, I am sorry. I was so busy, I didn't realize. I am sorry, Mr. Chairman. Thank you. Mr. Pitts. Thank you. [The prepared statement of Ms. Smith follows:] [GRAPHIC] [TIFF OMITTED] T7804.103 [GRAPHIC] [TIFF OMITTED] T7804.104 [GRAPHIC] [TIFF OMITTED] T7804.105 [GRAPHIC] [TIFF OMITTED] T7804.106 [GRAPHIC] [TIFF OMITTED] T7804.107 [GRAPHIC] [TIFF OMITTED] T7804.108 [GRAPHIC] [TIFF OMITTED] T7804.109 [GRAPHIC] [TIFF OMITTED] T7804.110 Mr. Pitts. The Chair now recognizes Ms. Crandall for 5 minutes for opening statement. STATEMENT OF LAURA CRANDALL Ms. Crandall. Good afternoon. Thank you. I am very grateful to have this opportunity to speak with you regarding the Sudden Unexpected Death Data Enhancement and Awareness Act. The problems that the bill seeks to address were first made known to me through a very personal experience. I recall July 30th, 1997 as a beautiful, beautiful gorgeous summer day as I sat out on our front steps waiting to awaken my daughter Maria from her nap. She had her 15-month checkup scheduled for later that morning, but I went to--when I went to wake her in her crib, I found Maria not breathing and blue. I called 911 on speaker phone, I started CPR, and even though the police arrived immediately and care was intervened immediately, she was transported to the hospital, heroic efforts. Maria could not be revived. A thriving, happy, walking, talking, beautiful little girl had died. We returned home from the hospital to find the police waiting for us with lots of questions and needing to investigate our home. A medical investigator from the ME's office called and came over the next morning to take pictures and ask many more questions and asked me to replay the most horrific moment of my life, how I found my daughter. Over the next few days, it was all we could do to plan her funeral and try to keep ourselves going on. I had no idea that during those same days that the investigation of Maria's death was the most crucial. I did not know that what was and what was not done at that time would have such a lasting impact on myself and the rest of my family. It is not like TV. Nothing happens quickly, and questions don't get answered in an hour, if they ever do at all. Two long years later, her investigation was concluded and a cause for her death was never found. So I am left with the understanding that her true cause of death was buried with her, and that is a tragedy of missed opportunities that I live with. I do not want to see this happen for other families in the future. Sadly, my story is not unique. There are many bereaved families who could sit in this chair and tell you the same story of tragedy, inexplicable loss, and missed chances. In 2010 alone, over 3,600 infants and nearly 200 toddlers died suddenly and without explanation, and in over 26,000 babies were lost to stillbirth. H.R. 669 efficiently addresses the core problems present in our country today to allow us to improve the collection of comprehensive and standardized information to better understand these presently inexplicable deaths. Regarding stillbirths. Nearly half of the 26,000 are unexplained. Its surveillance is very limited when utilizing fetal death records, which are often incomplete and insufficient. However, a CDC-funded effort to gather richer data through some existing State birth defects surveillance programs have shown success. Education of health care providers and expectant families is also limited and needed to teach the importance of known prenatal health initiatives. In regards to infant and childhood deaths, coroner and medical examiner offices have the authority in our country to investigate all unexplained, unexpected, and suspicious deaths, and therefore, the infant and child deaths that we discussed today fall under their purview. In this regard, it is very important to recognize that the death investigation systems in our country vary immensely from State to State and often from county to county. Therefore, the investigations that parents encounter are directly tied to where they live and the resources and the policies which their local medical examiner or coroner officer utilizes. The tracking of sudden unexpected infant death rates showed a significant drop in the early 1990s with the initiation of NICHD successful back-to-sleep campaign. Unfortunately, we have not seen any additional progress in lowering those rates further. As shown in the CDC graph I submitted in my written testimony on page 8, I believe, our progress as a country has seen a plateau for more than a decade, and if we are committed to see a change and prevent more of these deaths in the future, we must make a change in our process. The medical legal death investigation of these cases needs to be standardized, they need to be resourced, and the resultant data centralized and specifically studied. The Sudden Unexpected Death Data Enhancement and Awareness Act addresses these critical limitations in order to provide answers to families as well as our Nation overall. Specifically, it would improve the effectiveness of current activities of the CDC by removing the obstacles that impede their success today. This will be achieved by improving the surveillance of stillbirth by expanding on current programs, improving the surveillance of infant and child deaths by supporting comprehensive investigations, supporting evidence based public awareness campaigns and providing relief to families. Thank you for allowing me to provide my views on this important legislation, and on behalf of all the children gone too soon, my Maria being one of very many, thank you forgiving them a voice. I know they would want us to know what happened to them and help create a future free of tragedies for others. [The prepared statement of Ms. Crandall follows:] [GRAPHIC] [TIFF OMITTED] T7804.111 [GRAPHIC] [TIFF OMITTED] T7804.112 [GRAPHIC] [TIFF OMITTED] T7804.113 [GRAPHIC] [TIFF OMITTED] T7804.114 [GRAPHIC] [TIFF OMITTED] T7804.115 [GRAPHIC] [TIFF OMITTED] T7804.116 [GRAPHIC] [TIFF OMITTED] T7804.117 [GRAPHIC] [TIFF OMITTED] T7804.118 [GRAPHIC] [TIFF OMITTED] T7804.119 [GRAPHIC] [TIFF OMITTED] T7804.120 [GRAPHIC] [TIFF OMITTED] T7804.121 [GRAPHIC] [TIFF OMITTED] T7804.122 [GRAPHIC] [TIFF OMITTED] T7804.123 Mr. Pitts. Thank you. Thank you very much for your testimony. Mr. MtJoy, you are recognized for 5 minutes for your opening statement. STATEMENT OF ROBERT MTJOY Mr. MtJoy. Chairman Pitts, Ranking Member Pallone, and distinguished members of the---- Mr. Pitts. Pull your mike a little closer if you could, yes. Mr. MtJoy. My name is Robert MtJoy, and I am chief executive officer---- Mr. Pitts. Is it on? Is the red light on? Mr. MtJoy. It is on now. Mr. Pitts. OK. Good. Mr. MtJoy. My name is Robert MtJoy. I am chief executive officer of Cornerstone Care. On behalf of the 23,000 patients that we serve, our 186 employees, the entire health center community, including more than 22 million patients nationwide served by health centers, I want to thank you for this opportunity to testify today regarding the Family Health Care Accessibility Act of 2013 and for this subcommittee's strong support of health centers for many years. In particular, I want to thank Congressman Murphy for introducing this important legislation that would benefit health centers and their patients across the country by extending the Federal Tort Claims Act medical malpractice coverage to licensed health care professionals who volunteer their services at health centers. Health centers are community-owned, nonprofit entities providing primary medical, dental, and behavioral health care. By statute and mission, health centers are located in medically underserved areas or serve medically underserved populations. Health centers are also directed by patient-majority boards, ensuring care is locally controlled and responsive to each individual community's needs. Health centers provide primary care to all residents of their communities, regardless of their ability to pay or insurance status and offer services on a sliding fee scale. To date, there are over 1,200 health centers located across the Nation at more than 9,000 urban and rural health locations. Without their local health center, these communities and patients would often be without any access to primary care. Health centers have a demonstrated track record of improving the health and wellbeing of their patients, while at the same time, reducing unnecessary avoidable and wasteful use of health resources. Health centers reduce preventable hospitalizations, emergency department use, as well as the need for more expensive specialty care. Cornerstone Care was formed as a direct result of citizens who organized a board of directors and raised funds in 1978 to provide health care where before none had existed. The first doctors joined the organization in 1981. Dental care, soon after, in a small church building in a neighboring community. Thirty-five years later, Cornerstone Care provides a full range of primary and preventive health care services in Greene, Washington, and Fayette counties in southwestern Pennsylvania through its eight facilities, a mobile unit, and a teaching health center. Regarding the bill of interest to the committee today, by way of background, in 1993, Congress extended the Federal Tort Claims Act coverage to health center grantees by deeming them Federal employees for the purposes of medical malpractice coverage. The extension of the FTCA to health centers have resulted in significant savings for health centers, savings that have been used to expand access to care for millions of patients. There are health care professionals who want to assist health centers in serving their communities and addressing this unmet need by volunteering their services. However, the high cost of medical liability insurance often provides to be too burdensome for the provider and the health center, preventing these volunteers from doing so. While health centers are engaged in many workforce development initiatives, one immediate solution to alleviate this workforce shortage is the use of volunteer providers. By extending FTCA coverage to include volunteer providers, there will be more providers available to meet the needs of millions of patients who still lack care. Recruitment and retention of health care providers is one of the greatest challenges I have. And unfortunately, the looming critical shortage of primary care physicians will be more profoundly felt in rural areas like mine. We have got an aging physician population getting ready to retire, and this bill allows us to take advantage of this valuable resource. Mr. Chairman, there is significant unmet needs in our communities that health centers could address. The Family Health Care Accessibility Act is vital to the effort of addressing the Nation's primary care shortage. I would be remiss if I also forgot to mention two other vital programs that support the goal of creating medical homes for underserved Americans: The National Service Corps and the Teaching Health Centers Graduate Medical Education Program. These programs play important roles in addressing primary care workforce shortages and most--and both must be authorized soon if they are to continue. We look forward to working with you and other members of this subcommittee to improve access to primary care and reduce the overall health care costs in our community and across the country. [The prepared statement of Mr. MtJoy follows:] [GRAPHIC] [TIFF OMITTED] T7804.124 [GRAPHIC] [TIFF OMITTED] T7804.125 [GRAPHIC] [TIFF OMITTED] T7804.126 [GRAPHIC] [TIFF OMITTED] T7804.127 [GRAPHIC] [TIFF OMITTED] T7804.128 [GRAPHIC] [TIFF OMITTED] T7804.129 Mr. Pitts. The Chair thanks the gentleman. That concludes the opening summaries of our witnesses. We will now begin questioning by the members. I will recognize myself 5 minutes for that purpose. Dr. Nagele, since you are from Pennsylvania, can you describe for us how the Federal TBI State Grant Program impacted the State of Pennsylvania and its TBI population? Mr. Nagele. Yes. In Pennsylvania, we have had a HRSA grant for many years now, and one of the functions that we have used it for is training and education. We have trained many different types of people on what brain injury is and how to help people with brain injury to access brain injury services which are available. We had started training mental health workers and prison personnel, and the work that we did with the prison personnel have actually led us to another grant opportunity with the Pennsylvania Commission on Crime and Delinquency, and so the initial TBI Act funds helped us to leverage and get another grant where we are actually in the prisons now doing screening of inmates who are about to be released, and for those who are determined to have a brain injury, which is about 70 percent in our early---- Mr. Pitts. 70 percent? Mr. Nagele. 7-0 percent, yes. Mr. Pitts. What is the predominant reason for all the brain injuries? Mr. Nagele. Mostof them are mild repeated brain injuries that have never been diagnosed. So these inmates are not thinking of themselves as having had a brain injury. They are just thinking they got in a fight or they were in a car wreck or they were in a fall. They were never treated for these injuries, and as we are learning from the NFL studies, repeated mild brain injury can lead to much more serious problems in later life, and so these prisoners have had brain injury, but it has never been diagnosed, and our current work is to connect them with brain injury services when they leave the prisons so that they have every chance of success in the community and they don't end up back in prison. Mr. Pitts. Thank you. Ms. Crandall, I found your testimony very moving. H.R. 669 calls for the improvement of death scene investigations in the case of sudden unexplained death in childhood, including the collection of medical information, description of the sleep position, environmental factors. Would collecting this information significantly lengthen the time it takes to complete the current investigation? Ms. Crandall. No. And the guidelines currently exist for scene investigation through the CDC, were first created in the mid 1990s and then revised in 2005, I believe. Those guidelines are out there, but they are not universally utilized for infants, and that information is very helpful to the pathologist prior to them performing the autopsy, so they know what may be a concern and whatnot. So those guidelines are out there right now. Those are ideally captured within, on the day of the death, when the death investigator goes to the place where the infant or child died and interviews the caregivers and collects that important data. So, it would not increase the length of time. Mr. Pitts. Do you know if local police or other law enforcement authority support these changes? Ms. Crandall. I believe in the last legislative session, I know that the--there was a National Sheriffs Association, I believe, that endorsed the bill. In general, again, death investigations vary so greatly. In some areas, local law enforcement are the deathinvestigators, and in other areas, they are medical legal death investigators from the medical examiner's office or coroner's office doing an investigation in parallel, so it varies from jurisdiction to jurisdiction on how these would be carried out, but the information from law enforcement is very helpful to them in terms of giving them a guidebook of what to follow. As you can imagine, these are emotionally and very chaotic scenes. It is very difficult. It is some of the most difficult investigations that death investigators say they need to respond to as well as law enforcement because the scene is completely disturbed by the time they get there. So, their ability to effectively interview a distraught parent, to get that accurate information of what really happened really takes an important skill set, and that is why the training for these death investigators is so important. It is really a unique highly skilled ability that they need to have to be able to collect this information and do it in the most compassionate way for the families. Mr. Pitts. Thank you. Ms. Smith, one of our colleagues, who does not serve on the Energy and Commerce Committee, Chris Gibson from New York's 19th District, has been a tireless advocate for his constituents on the issue of Lyme disease, and he has submitted a question that he would like me to ask on his behalf. Ms. Smith, you mentioned the concentration of existing research dollars and the lack of diversity and coordination in Lyme research, and this was a helpful analysis. Can you identify any areas of progress first, and what has worked and been helpful and what has not? Ms. Smith. I am sorry. I have a little bit of hearing impairment. Could you just repeat the last portion of that question? Mr. Pitts. Yes. What has worked and has been helpful and what has not worked or been helpful? Ms. Smith. I am sorry, in regards to? Mr. Pitts. As far as areas of progress---- Ms. Smith. Oh, OK. I am sorry. Mr. Pitts [continuing]. In your analysis. Ms. Smith. OK. So as far as areas of progress, I think what has been helpful is in recent times that I think there has been more agency interest and more agency coordination in focusing on the amount of disease across the country. And so I think that because of that, the amount and the diversity of the disease, I mentioned the number of tick-borne diseases that are being transmitted, and so on and so forth, I think that that has all come into play to begin to focus research, not just on Lyme disease, but on other tick-borne diseases. How do patients react if they have more than one disease? You know, how are they able to diagnose? Because many of them don't have tests to diagnose, unfortunately, with, they don't have particular treatments for certain viral diseases. And so I think the fact that now that the information is being more freely shared about these tick-borne diseases and it is coming in from a lot of university studies that are being done, not just in the United States, but throughout the world, I think that has been extremely useful. Mr. Pitts. Thank you. My time has expired. I am sorry to go over. Mr. Pallone, you are recognized 5 minutes for questions. Mr. Pallone. Mr. Chairman, I wanted to submit for the record endorsement letters from 24 organizations. This is with regard to the H.R. 669. Mr. Pitts. Without objection, so ordered. 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And I wanted to mention that--because you mentioned law enforcement and, you know, their support for the bill--and I just wanted to mention that 3 of those in the 24, the National Association of Medical Examiners, the International Association of Coroners and Medical Examiners, and the Society of Medicolegal Death Investigators, are, you know, enforcement, just for your information. But before I get to questions, Mr. Chairman, I wanted to address both you and the subcommittee for a moment. I just wanted to be sure to express my disappointment that the subcommittee didn't give the administration enough time to be here today to have input on these seven public health bills. As you know, many of the bills cross a number of agencies at HHS, and it is critical that they are able to give us their expertise on these proposals. So I was going to ask if you could commit to me that we will arrange for some way to have the administration's technical views be heard by our staff and members. Mr. Pitts. I am informed that we are in the process of getting technical information from the administration. Mr. Pallone. All right. And then, Mr. Chairman, I also wanted to enter into the record a statement by Congressman Bill Pascrell with regard to his bill, the Traumatic Brain Injury Reauthorization Act. Mr. Pitts. Without objection, so ordered. [The information follows:] [GRAPHIC] [TIFF OMITTED] T7804.157 [GRAPHIC] [TIFF OMITTED] T7804.158 Mr. Pallone. Thank you, Mr. Chairman. Let me see, I wanted to start with Ms. Crandall. I don't know if I can get through all these, but I am going to try. I wanted to thank you again for being here and, you know, sharing the heartwrenching story about the loss of your daughter Maria. And in your testimony, you also shared some sobering statistics that over 3,600 infants and 200 toddlers die suddenly each year. You noted that 26,000 women experience stillbirth. Clearly we need to do something to address this. The Sudden Unexpected Death Data Enhancement Awareness Act that I sponsor contains provisions that will build upon the current CDC activities and ultimately help prevent these deaths from occurring. And I am sure I don't have to tell you that we are in a difficult fiscal climate. As much as I would like to advance all the provisions in H.R. 669, I recognize that that may not be feasible. So I just wanted to ask you, in light of these constraints, what do you believe are the most important areas or provisions for us to address? Ms. Crandall. I strongly feel that the most important areas are the comprehensive investigations that would then allow for effective surveillance and then public awareness and intervention strategies. I think if we don't fix the issue of these cases initially being investigated thoroughly, we will never have the good data that will then later on help public health and research, and as well as these families on an individual basis. But there are many efforts going on right now that have huge obstacles in front of them because they are dealing with broken data. I think we need to go back and prioritize the investigations. Mr. Pallone. All right. Thank you so much really again for your testimony and all your support in getting this moved. Dr. Nagele, if I could ask you, in your testimony you discussed movement of State TBI and protection and advocacy programs currently administered by the Health Resources and Service Administration to the Administration for Community Living, and you noted this would help foster greater collaboration between TBI and aging and disability programs. You also cited some additional benefits of a potential reorganization. For example, you mentioned greater collaboration on TBIs among older adults resulting from falls. Can you elaborate on how movement of TBI programs to ACL will be beneficial for individuals with TBI and their families? Mr. Nagele. Yes. We believe that elevation to the ACL will help people across the age span to better recognize the effects of brain injury and to coordinate with the many services that sit within ACL, within intellectual disabilities and with aging, and that this opportunity will actually give more ability to leverage with other existing programs. Mr. Pallone. All right. Thank you. I think I am going to get in all three questions. Mr. Stack. Dr. Stack, you know, I have been involved with NASPER for a long time with Mr. Whitfield. It is clear from your testimony that NASPER and other prescription drug monitoring programs, or PDMPs, are an important tool in helping to address the problem of nonmedical use of prescription drugs. As you know, State PDMPs collect, monitor, and analyze information on scheduled or controlled prescription drugs. You noted PDMPs provide valuable info for physicians, pharmacists, and other health providers to support appropriate prescribing and treatment for pain management. And you also mentioned the importance of NASPER's public health focus. So if I could ask you, why do you believe the public health focus of NASPER is so important, and how does that differ from the emphasis of other monitoring programs? Mr. Stack. Well, I would say there is a difficult balance between two different issues here. One is treating patients who have pain. And the Institute of Medicine estimates there are as many as 100 million Americans who live with chronic daily pain that is inadequately treated. And then the difficulty of an epidemic, and I think we would all agree it is an epidemic, of prescription drug abuse and the horrible damage and devastation that causes. So it is a public health magnitude kind of problem, because we have to address competing needs in society, the treatment for one, which has grave consequences when misapplied or misused for other folks. We would suggest that it is a public health as opposed to principally a public justice issue or a legal issue, because these are our fellow men and women and children who require treatment and care for various problems and maladies. And we believe very strongly that it is a health-related issue, that if we attend to that particular concern and work together as a society, we will get far further in helping our fellow men and women than incarcerating them all and pursuing them through the justice system. So we can't emphasize strongly enough that we believe the health-based approach is the proper approach. Mr. Pallone. And I appreciate that. That is very helpful. Thank you very much. Thank you, Mr. Chairman. Mr. Pitts. The Chair thanks the gentleman. Now recognize the gentleman from Kentucky, Mr. Whitfield, 5 minutes for questions. Mr. Whitfield. Well, thank you, Mr. Chairman. And I would like to thank all of the witnesses for joining us today and giving your views on this important legislation. Dr. Stack, I would like to follow up on the prescription drug monitoring programs as well. As you know, the first program came out of the Appropriations Committee and was placed over at the Department of Justice and was primarily focused on law enforcement issues, abuse. And then Mr. Pallone and I and others, Mr. Pitts and others, authorized the national Prescription Drug Monitoring Program. And as you have indicated in your testimony, ever since we started the program we have had difficulty getting the necessary appropriations, and we still are having difficulty doing that. We tried to merge the programs, and we have had some difficulty even doing that. But I guess the good news is that it is my understanding that now 47 States do have a prescription drug monitoring program. Certainly they are not all the same. But in your testimony, I think you referred to in Ohio in the emergency rooms, that you said 40 percent of providers, based on information they have received on the prescription drugs, change their prescription orders. Mr. Stack. Right. So in that particular study they found that 43 percent of prescribers produced less or prescribed no opioids at all based on the information they received. There is a second side to that, though. When I and my colleagues practice, there are quite a number of times when we look in the database and find that a patient has received no opioids ever. And in fact that helps to validate and help us to feel more comfortable that a short course of treatment is appropriate---- Mr. Whitfield. Right. Mr. Stack [continuing]. In that patient. It helps both ways. Mr. Whitfield. Well, do you feel that the KASPER program in Kentucky is doing well or do you have any suggestions of how we could improve it or---- Mr. Stack. So the KASPER program in Kentucky has come a long way. As recently as 2011, there were strong prohibitions in who could see it, who could share it---- Mr. Whitfield. Right. Mr. Stack [continuing]. Enter it into the medical record. That has rapidly evolved, as you know, with House Bill 1 in the State of Kentucky and then the legislation the following year, in 2013, that made some corrective actions. So I would say that the KASPER program in Kentucky is evolving well. It did teach and show, I believe, something we feel strongly about, which is these tools are so rapidly evolving and are so uneven and heterogeneous across the country that mandating the use of these programs is not the appropriate approach; that, in fact, if we would work to standardize them, make them interoperable, and have realtime data, meaning I ask the database for an answer and I get it quickly, that the clinicians will use these tools when they function well. And we are only just beginning down that path. Mr. Whitfield. So you don't think mandating is necessary then? Mr. Stack. I don't think so. I think with countless other things, physicians have shown when the technology works and helps patients, we adopt it---- Mr. Whitfield. Yes. Mr. Stack [continuing]. And when it is broken and doesn't work, we generally don't find it useful. Mr. Whitfield. Yes. Mr. Stack. We are getting to a better place. But NASPER is essential, because the States are so all over the map for the immaturity of their programs and the fact that they don't communicate with each other yet---- Mr. Whitfield. Right. Mr. Stack [continuing]. That the relatively small investment on the Federal Government could help to jump start a profound evolution in advancement in these programs. Mr. Whitfield. Yes. Well, I really appreciate your taking time to come up and talk about it. As I said, we appreciate the issues that all of you have discussed. And as we move forward, Dr. Stack, maybe we could get together sometime and get some additional ideas from you on ways that we can try to merge these programs so that they can be as efficient and technologically advanced as possible. Mr. Stack. The AMA is definitely committed to working on this issue, and we would be happy to do that. Mr. Whitfield. Thank you so much. Oh, I yield to Dr. Burgess. Mr. Burgess. Oh, I am sorry. I have to leave. Mr. Whitfield. Oh. OK. Got to leave. Mr. Pitts. The Chair thanks the gentleman. Now recognize the gentleman from Texas, Mr. Green, for 5 minutes for questions. Mr. Green. Thank you, Mr. Chairman. And I want to thank our panelists and thank the Chair and the ranking member for listing this number of bills on our schedule for today, because each of them address a certain part. And some of us who have been on the Health Subcommittee for years have dealt with these before, and, again, we appreciate your time this afternoon. And I would like to thank Mr. MtJoy for taking time to testify for the Family Health Care Accessibility Act, which would greatly benefit health centers and their patients. That just happens to be the one that Congressman Murphy and I have been working on. It seems like this is our third Congress. We passed it out of the House twice, and the Senate hasn't taken it up. In your testimony, you mention issues facing community health centers regarding recruitment and retention of healthcare providers. There are programs like the National Service Health Corps, but even the current number of National Health Service Corps scholarships and awards, there is a primary care shortage. Can you give us some examples of why health centers have difficulty retaining or recruiting providers? Mr. MtJoy. Well, even with the recent investments in expanding the National Health Service Corps, the demand still outpaces the supply of healthcare providers. And this is particularly true in rural areas, such as where I am from. Healthcare providers generally aren't from rural areas, whereas we try a number of initiatives to what I will call grow your own. Certainly recruitment and retention is one of the largest or most challenging areas of providing healthcare, certainly for us. Mr. Green. And I know there are a lot of programs over the years have tried to encourage, you know, loan forgiveness and things like that to have physicians go to rural areas. How will the Family Health Care Accessibility Act help health centers meet that growing demand for primary health care? Mr. MtJoy. Well, again, it will expand our provider base. And as we struggle to meet the demands of our patients, recruitment and retention of providers, expanding our primary provider base is one more method of helping us do that. Mr. Green. And I know, I represent a very urban area in Houston, Texas, and our federally qualified health centers have some of the same challenges, even though we have three medical schools within 50 miles, of attracting primary care physicians. You stated that one untapped resource for meeting the demand for primary care is volunteers, and especially retiring or retired health practitioners. If Congress were to pass the Family Health Care Accessibility Act, what type of practitioners would you hope and expect to volunteer their time in your health centers? Mr. MtJoy. Well, I have spent or focused most of my attention on physicians, but in addition to physicians, for instance at Cornerstone Care and other community health centers across the country, this also includes nurse practitioners, physician assistants, dentists, licensed social workers, et cetera. So, again, it crosses the gamut of provider types. Mr. Green. And I have always said if I can get a primary care or a person, not even a volunteer, into community health centers, they would know they can actually practice medicine and maybe make a decent living for their families. Can you explain to the members of the subcommittee how training in health centers increase the likelihood that an individual would be more likely to stay in the community where they complete their training? Mr. MtJoy. Well, absolutely. We try to expand our provider base by providing training opportunities for a variety of disciplines that I have just mentioned, from PAs to nurse practitioners, et cetera. Recently Cornerstone Care became one of the new teaching health centers, and we have got our first class of residents now in the program and recruiting our second. We have found that when healthcare providers, particularly physicians, do their training or part of their training at community health centers, they are two-thirds more likely to return to that type of practice following their training. Mr. Green. OK. Thank you, Mr. Chairman. I will yield back a few seconds. But again, thank you for scheduling this bill today. Mr. Pitts. The Chair thanks the gentleman. Now recognize the gentleman from Virginia, Mr. Griffith, 5 minutes for questions. Mr. Griffith. Thank you very much, Mr. Chairman. I, too, am very appreciative of the fact that we have all of these witnesses here, and the testimony that you gave on each of the various issues was very important and enlightening. Mr. Chairman, I will take a minute to talk about Lyme disease and ask a question of our witness on that, Ms. Smith. But Lyme disease is a growing problem throughout our State, but it is endemic in northern Virginia. Our representatives from the local, State, and Federal levels are working aggressively to raise awareness about this issue for our citizens and medical providers to encourage prevention, quick diagnosis, and treatment. My colleagues and I in the Virginia delegation, particularly Congressmen Frank Wolf and Rob Wittman, appreciate you having this hearing. I should also mention that Barbara Comstock is working on this in the Virginia House of Delegates, as well. Ms. Smith, H.R. 610 requires that Tick-Borne Diseases Advisory group include members that represent State and local healthcare professionals, individuals who have firsthand experience with tick-borne disease, and representatives of a tick-borne voluntary organization. How do you think this will help to enhance communication amongst the Federal agencies? Ms. Smith. Well, I think, unfortunately, what has happened right now is oftentimes what I see is that the agencies--now, they are trying to do a good job in their area, but it is not always communicated into other areas as to what kinds of projects they are doing. Plus, there is really not a national strategy to attack tick-borne diseases. And so over the 30 years what I have seen, the numbers have grown, you know, greatly, the numbers of ticks, the numbers of diseases. And so if you put people on there who have perspectives-- for example, we have no clinical treating physicians have a perspective right now, are able to give their perspective to the Federal Government about what research projects they feel are important. They are seeing a lot of people with very serious chronic Lyme disease, which is different than just getting a tick bite and getting, you know, a few weeks and getting better. So they are seeing people with these debilitating symptoms. They have all this knowledge that they have gleaned from many years of treatment, and they are able, for example, to look at the results of Lyme disease testing, and sometimes, even though the test may come back and it says it is negative, they are able to read the bands from their clinical experience and determine, yes, these people really do have Lyme disease and they require extensive treatment. And so they would be able to take this kind of knowledge, because one of the biggest factors, and I think everybody agrees on this, we need testing that is, you know, a gold standard. We don't have that now. We are missing so many patients, and they go on to develop these intense symptoms that are not only causing them a lot of health disability, but are also causing obviously great, tremendous costs to their families, to the government, et cetera. So if the clinicians could provide their input, it would be a better chance that we could get diagnostic tests. Also, tests need to be found that will determine whether someone has active infection. Mr. Griffith. And you believe that this bill will help that. And I do appreciate it and appreciate your testimony. I am going to move on to another subject, because, unfortunately, while I would like to talk to each one of you, I only have a few minutes. That being said, I will move to the NASPER bill and pick up where Congressman Whitfield left off. It is a very serious issue in lots of the country. It is particularly a serious problem in my district in southwest Virginia. A study done there by the United States Attorney's Office for the Western District of Virginia found serious problems, that this was a major impact on our region. And the study also cited that just four counties, which have 1 percent of Virginia's population, accounted for the Virginia State Police spending 25 percent of their statewide undercover purchase funds buying prescription medications in those four counties. Likewise, the chief medical examiner's office in Roanoke says that deaths are up by 40 percent as a result of the activities with prescription drugs. Doctor shopping contributes to this spread. I think we need to do more to prevent this practice, which is why I support the lock-in mechanism that many private insurers are utilizing, and I think that would be helpful. Dr. Stack, is there anything you would like to in 23 seconds tell us what you didn't touch on when you were answering Mr. Whitfield? Mr. Stack. No. We share that this is critical, but you just touched in your own testimony how it is a variable problem that affects different communities more intensively, which is why we don't believe a one-size-fits-all for some of the other strategies is appropriate, because it will misapply strategies in some areas and under-apply them in different places. So we believe NASPER, everyone agrees, all the stakeholders agree these PDMPs are an essential tool. The other strategies, we could have a longer discussion another day about where they may be best applied. Mr. Griffith. I appreciate it very much. And with that, Mr. Chairman, I yield back. Mr. Pitts. The Chair thanks the gentleman. Now recognize the gentleman from New Jersey, Mr. Lance, 5 minutes for questions. Mr. Lance. Thank you very much, Mr. Chairman. Good afternoon to the panel. To Dr. McCabe, the Senate bill, the companion bill, contains a priority review process for nominating new diseases that meet certain criteria. Would you please discuss with us this provision and its impact on the screening process and the health of children. Mr. McCabe. Yes. That is a difference between the two bills. We feel that it is important as the March of Dimes that there be timely, swift consideration of new entities, and these were submitted from the Secretary's Advisory Committee. So there needs to be rigorous scientific integrity around that, but we do feel that there needs to be swift movement once action is taken by the Secretary's Advisory Committee. Mr. Lance. Thank you. We are hearing increasingly that in the not-too-distant future, next generation DNA-based sequencing may allow the rapid analysis of a newborn's genome, possibly replacing some or even all of the current newborn screening techniques that rely on biochemical changes in the blood. Do you see that is happening in the near term and do you have any thoughts on the advantages or disadvantages of genome sequencing compared to current techniques? Mr. McCabe. That is something I have watched very closely, because my lab was the first to show that you could get DNA---- Mr. Lance. Yes. Mr. McCabe [continuing]. From the newborn screening spots. The NIH has funded, both NHGRI and NICHD, have funded four institutions to look at this problem, not only to look at the technology and can you sequence in a reliable fashion from the DNA in the newborn screening, but all of the ethical, legal, social implications, and policy issues around that. So I think this is important work that you bring attention to, and it is being funded now by two institutes that are heavily invested in this, and we are all looking forward to the results. Mr. Lance. Do you think that H.R. 1281 should be altered in any fashion to take into account what we were just discussing? Mr. McCabe. I think that the research has just begun. Those are 5-year research projects that were just established. I think there would be opportunities in the future. Certainly I think it is important to recognize that there may be other technologies, such as DNA sequencing, that will come along. I think it is also important to recognize that there is NICHD authorization for funding for the project to continue to develop new technologies in the future. But, yes, it should encompass new technologies, but I think that is one of the things that the Secretary's Advisory Committee would allow. It allows the community to be nimble if new technologies do come along. Mr. Lance. Thank you very much. To Dr. Ford, can you point to a specific example of a situation where a poison center's being located within a community or geographic area has benefited public health surveillance? Ms. Ford. Yes. Well, first of all, I think that in many ways with regard to emergency preparedness planning, working with EMS, the public health outreach, the education of the healthcare providers in a region that are done through the regional poison center are very, very important. It was one study done that showed that as the distance between a poison center and the caller increases, it is less likely that that caller is going to call that poison center. Mr. Lance. Yes. Ms. Ford. And I believe that that probably needs to be studied further, but I believe that it is true that you are more likely to use a service that you are more intimately associated and familiar with. Mr. Lance. Thank you to this very distinguished panel. And I yield back the 30 seconds I have. Mr. Pitts. The Chair thanks the gentleman. That concludes the questions of the members present. Other members will have questions, and we will have some follow-up questions. We will submit those to you in writing. We ask the witnesses to please respond promptly. Thank you very much. This has been very important information, very important issues. We thank you for coming today. I remind members that they have 10 business days to submit questions for the record, and that would be by the close of business on Friday, December 6th. Thank you very much for your attendance. Without objection, the subcommittee is adjourned. [Whereupon, at 4:28 p.m., the subcommittee was adjourned.] [Material submitted for inclusion in the record follows:] [GRAPHIC] [TIFF OMITTED] T7804.159 [GRAPHIC] [TIFF OMITTED] T7804.160 [GRAPHIC] [TIFF OMITTED] T7804.161 [GRAPHIC] [TIFF OMITTED] T7804.162 [GRAPHIC] [TIFF OMITTED] T7804.163 [GRAPHIC] [TIFF OMITTED] T7804.164 [GRAPHIC] [TIFF OMITTED] T7804.165 [GRAPHIC] [TIFF OMITTED] T7804.166 [GRAPHIC] [TIFF OMITTED] T7804.167 [GRAPHIC] [TIFF OMITTED] T7804.168 [GRAPHIC] [TIFF OMITTED] T7804.169 [GRAPHIC] [TIFF OMITTED] T7804.170 [GRAPHIC] [TIFF OMITTED] T7804.171 [GRAPHIC] [TIFF OMITTED] T7804.172 [GRAPHIC] [TIFF OMITTED] T7804.173 [GRAPHIC] [TIFF OMITTED] T7804.174 [GRAPHIC] [TIFF OMITTED] T7804.175 [GRAPHIC] [TIFF OMITTED] T7804.176