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request and initiatives in ned sin and biomedical research. next, a house subcommittee looks at the efforts of fed agencies and courts to combat prescription drug abuse, particularly pain-relieving medications. witnesses include the policy director and officials from health and human services, the national institutes of health and the centers for disease control. from capitol hill, this is two hours.

well, good morning. welcome here to the oversight investigation and subcommittee hearing. it's health month so it's fitting that we are here today on this issue. this is a third in a series of hearings examining the growing problems of prescription drugs and heroin addiction that is ravaging our country. this is our nation's single biggest public health concern. over the past five weeks a subcommittee has heard from addiction experts working with local communities and our leading academic and research centers. dr. robert dupont, former drug control policy and director of the national drug abuse testified that federal programs lack direction and standards on treating addiction as a chronic addiction and note whadt is being

done to prevent relapse. he challenges us to ask the most fundamental question, what is rediscovery? dr. anna lemke provided critical testimony on how we must revise our health care quality measures to reduce overprescribing, reform privacy regulations and incentivize the ooze of prescription drug monitoring programs. we know that those addiction disorders need a broad treatment options that many with substance abuse disorders have a psychiatric disorder. about three weeks ago one of today's witnesses mr. michael bottacelli, presented a slide. i'm going to show it here at the national summit on major causes of death from injury from 1999 to 2013. quite a revealing slide. while the trends of other major cause of death such as auto accidents went down, drug

poisoning goes up 21% from 2008 until 2013. in many states these numbers are soaring at high double-digit rate increases. as the doctor has indicated to me at the summit, we must do better and we have much work to do. today, we will hear from federal agencies charged with providing guide guidance and leadership to the opioid epidemic. the department of health and human services, or hhs, and its substance abuse and mental health administration also known as samha regulates our countries 1300. according to testimony provided

in april of last year there were nearly 1.5 million people treated with these opiate medication with a five-fold increase in the last ten years. has samsa defined the role of recovery for what these treatment programs are supposed to accomplish? are they collecting data at an individualized level that would hold individuals responsible for the results? so far the answers indicate that it is no. when you don't define where you are going, every road you take leaves you lost. we are hoping that we can get some direction today. the numbers indicate we are failing as a nation. we darn well better come to terms with that. the 43,000 lives lost year the thousands of babies born addicted to opiates tell us the terrible toll that this epidemic has taken. you heard my thoughts about the addiction maintenance and i've

referred to heroin helper, not because it's altogether lacking but rather because infrastructure the federal government has used for this highly potent medication is not fully working and worse yet, in many cases it's contributing to the growing problem. this has to be fixed and i hope we'll find solutions and that's what we need to discuss today openly honestly, and humbly. if we do not reverse the current trend, where is this going to end? how many millions of citizens do we want to have on opiate maintenance? how many more must die and how many more lives and dreams must be shattered before we recognize the depth of this. i don't believe better living through dependency. this is not a general indictment of opiate maintenance. for some people it's the bridge treatment and there should be no shame or stigma associated with it. but it should not be the only thing offered and it's not the only goal. what patients can be

successfully transition off of these medications or protocols best for effecting this transition. what are the best practices for prevention of relapse for those patients who end opiate maintenance treatment. there are nonaddictive medications approved for this use but are the medications widely available and how well do they work? the diversion for illicit nonmedical use is how the opiate addiction can be spread. where is the call to modernize existing treatment system tone sure the right patient gets the right treatment at the right time? why aren't we hearing about expanding access to nonnarcotic treatments? these are all incredibly important tools and we want to make sure hhs talks more about these. last week dr. wesley clark the former director of samsa center and who oversaw the growth over

the last decade declared before the american society of addiction medicine that many practices have become pill mills where doctors and dealers were increasingly indistinguishable laboratory fraud prevailed. the problem is not with upineprine, however. and this is what we need to discuss. i consider this as a bridge to cross over in the recovery process. as i said, it's not a final destination. we seek to lay out a recovery that is an option. for cancer, diabetes, aids, we want people to be free of the diseases, not just learn to live with it. we need to commit the same sorts of things to research and clinical efforts that boldly declare what we must change here. i thank our witnesses for being here and i recognize ranking member of the subcommittee mrs. degette from colorado for five minutes. >> thank you, mr. chairman. i think it's really important to

hear from our witnesses about the work that the federal government is doing to address this serious public health issue and i know all of the agencies represented before us do critical work to prevent and treat this ep depidemic. in march i applaud the department's actions and i'm gratified to hear that this is one of the secretary's top priorities. i want to hear more about this initiative today and how all the agencies before us are working together to accomplish its goals. but at the same time, i have some hard questions about our approach to caring for those who have substance abuse disorders. last week we heard from a panel of medical experts who have vast experience in treating opioid addiction. unfortunately, as the chairman said, they gave us a fairly bleak view of the opioid treatment landscape in this

country. for example, one witness, a psychiatrist as columbia university and a research scientist at the new york state psychiatric institute, told the committee that the majority of patients being treated for opioid addiction received treatment that is both, quote, outdated and quote, mostly ineffective. he described this approach of rapid detoxification followed by an absence only method without the use of important treatment medications. the doctor added that this is potentially dangerous because it raises the risk of an overdose if a patient relapses. as troubling as this testimony from our last hearing was, today we have dr. volkow on our panel, one of the world's top experts on addiction research. and she notes, i'm sure you'll talk more about this doctor, in her written testimony that, quote, existing evidence-based prevention and treatment strategies are highly underutilized across the united

states. why is that mr. chairman? why do we have experts week after week telling us that the bulk of the treatment that americans are receiving for this devastating disease are ineffective, outdated and not evidence-based? we need to be asking ourselves some tough questions. for example, the president of the american academy of addiction addiction said that detoxification treatment and drug-free counseling are associated with a very high risk of relapse. are patients enrolled in treatment getting sufficient data so they can make medley informed choices? are family and loved ones being told what approaches have high failure rates before choosing an approach to treatment? frankly, this is not a decision that should be taken lightly. getting ineffective treatment may not only be financially costly but it may result in a

fatal relapse. finally, mr. chairman, recent testimony, including some i saw in the written statements for today, raises important questions about whether taxpayer dollars should fund certain approaches for combatting this opioid epidemic over others. this is an issue i've been talking about week after week. we all agree we need the most effective treatment. and our experts agree that this treatment needs to be a broad menu of options that is different from patient to patient. so we might not have a silver bullet to cure opioid addiction at this point but we know what treatment works better than others. evidence tells us and all of the experts agree, that for most patients, a combination of medication-assisted treatment and behavioral treatment such as counseling and other supportive services, is the most effective way to treat opioid

addiction. if that's the case, we should pursue more policies that encourage this approach as a clear option and steer away from any efforts that are not evidence-based. it's costly and it's dangerous to the patient. so i hope we can all work together to fight this epidemic. and i do look forward to hearing from all of our witnesses. i'm glad secretary burwell and the department are devoting serious attention to both the prevention and treatment sides of this problem. mr. chairman, this has been a really great series. i'm happy to have a whole investigation like this in this committee. there is one group that we haven't heard from yet. i'm hoping -- >> we will. >> good. we haven't heard from the states yet. it's critical we hear from them because that's where the rubber's hitting the road. we need to hear what the states are doing to address this problem and understand the reasoning between -- behind some of the choices being made. some states are picking

effective treatment methods and others are not. so i think we need a multifaceted approach. this is what our research has showed. i know we can work together to continue this important investigation. i just want to add one more note, the witnesses and the audience may see members jumping in and running out. we have another hearing in energy and commerce committee going on down on the first floor. so people will be coming and going. but i know certainly from my side of the aisle people recognize this as a very serious issue. thank you. >> and i know they'll be calling votes at 9:30. >> i thought it was 11:00. >> i'm here for the duration. so we want to hear from you. and hopefully the members. now we recognize mr. upton. >> we really are going to have votes at 9:30? >> we are. >> i'm going to submit my statement for the record then. yield back. >> all right. mr. pallone five minutes. >> i'll do the same because we both have to go to the other

hearing. >> see how much we get along? is there anybody else on either side that needs recognition? >> no let's go into this. >> wait. mr. kennedy. >> mr. kennedy? >> he wanted a minute. can i -- mr. chairman, can i yield just one minute? >> yes, you can yield your minute to mr. kennedy of massachusetts. >> thank you very much for the consideration. i yield back. >> all right. let me now introduce the witnesses on the panel for today's hearing. we have the honorable michael bottacelli, part of the executive office president, welcome. dr. frank, secretary for planning evaluation of health and human services dr. volkow, dr. douglas throckmorton a deputy director of the drug evaluation for the food and drug administration, dr. deb before

houry. director of the national injury and prevention and control at the center's for device control and prevention dr. honorable hyde and patrick conway, innovation and quality for medicaid and medicare services. welcome. you are aware that the committee is holding an investigative hearing and when doing so has a practice of taking testimony under oath. do you have any objection to testifying under oath? none of the witnesses are -- have objection. the chair advises you under the rules of the house and committee that you're entitled to be advised by counsel. none of the witnesses say so. so in that case, please rise raise your right hand i'll swear you in. do you swear that the testimony you're about to give is the truth, the whole truth and

nothing but the truth? >> yes. >> thank you. all witnesses answered in the affirmative. you are now under oath. and subject to the penalties under section 1001 of the united states code. you may all give a five-minute statement. please stick to the five minutes. >> we're not going to get through it. >> thank you, chairman murphy, member degette for the opportunity to provide testimony to you today about the administration's efforts to address the opioid academic in the united states. mr. chairman, as you recognized in 2013, almost 44000 died of a drug overdose. that's one death every 12 minutes. using the rule as the coordinator of the federal drug control agencies, in 2011, we pursued the prevention plan to address the sharp rise in prescription opioid drug misuse in this country since 1999. as you know, the plan consists of action items categorized

under four pillars. education of patients and subscribers, increased prescription drug monitoring, proper medication disposal and informed law enforcement. with the work of our hhs partners here today and other federal partners as part of the work group convened by ondcp we have made some strides in each of these areas but there is much more to be done. since time and education programs devoted to the identification of treatment of substance use disorders is rare we have worked with our federal partners to develop continuing education programs about substantial abuse, managing pain appropriately and treating patients using opioids more safely. many prescribers in federal agencies, including hhs are receiving this important training. despite this, a large percentage of prescribers have not availed themselves of this training. therefore, the administration continues to press for mandatory prescriber medication. i am pleased that secretary

burwell has expressed her support to set requirements for specific training for opioid prescribers. today, all states but one, missouri, have prescription drug monitoring programs that allow prescribers to check on drug interactions as well as alert them to the signs of dependence on opioids. missouri is working to authorize that program. with all states implementing pdmps, we are working on state-to-state data sharing within the health record system providers use every day. in october, the drug enforcement administration's final regulation on controlled substances disposal became effective. our stakeholders have looked for ways to stimulate more local disposal programs in partnership with pharmacies, local government community groups and local law enforcement. in the work of our law enforcement partners at the

federal, state and local levels is ongoing. those engaged in fraud across the drug control supply chain are being investigated and prosecuted. recent data shows we are seeing an overdose from prescription opioids leveling off in this country but a dramatic 39% increase in heroin overdoses from 2012 to 2013. this is creating an additional need for treatment in a system where a well-known gap between treatment capacity and demand already exists. therefore, we must redouble our efforts to address people who are misusing prescription opioids since we know this is a major risk factor for subsequent heroin use. earlier this week, the administration held the inaugural meeting of a congressionally mandated interagency heroin task force. mary lou leery is one of the co-chairs for this committee. in addition, the president's fy 16 budget request includes $99 million in additional funds

for treatment efforts. we have also been working to increase access to the emergency opioid overdose reversal drug naloxone so witnesses can take steps to help save lives. many police and fire departments have already trained and equipped their personal with this life-saving drug and loved ones with opioid drug abuse disorders are equipping themselves as well. while law enforcement and other first responders have an important role to play the medical establishment must become more engaged to identify and treat heroin and opioid prescription disorders. every day these people appear in our emergency departments and other medical settings and more models and interventions are needed to get these individuals engaged their care. we need to extend availability of evidence-based opioid treatment. medication assisted treatment combined with behavioral and other recovery supports have been shown to be the most

effective treatment for opioid disorders. decisions about the most appropriate treatment options and their duration need to be agreed upon by both the patient and treatment provider. we must also provide community support, such as access to housing, employment and education to give patients the functional tools they need to lead healthier lives and integrate into the community as part of their recovery process. while we support multiple pathways to recovery, the literature shows that short-term treatment, such as detoxification alone is not effective and carries risk of relapse and overdose death. because of the lack of availability of evidence-based treatments and the strong connection between injection of opioid drugs and infectious disease transmission, we also promote the use of public health strategies that will help prevent the further spread of infectious disease. the hiv and hepatitis c outbreak in indiana is a stark reminder of how it can spread other

diseases, how health strategies such as syringe exchange programs need to be part of the response to the opioid epidemic and how rural communities that have limited treatment capacities, may have additional public health crises. finally, we're addressing neonatal absence syndrome. research shows that the incidents of nas has grown five-fold between 2000 and 2012 and 81% of the hospital charges for nas were attributed to medicaid. we must consider that the best interest of babies with nas is often served by best addressing the interests of the mother. therefore, we need to provide safe harbor for pregnant and parenting women seeking prenatal care and treatment. in conclusion, we look forward to, working with congress on the next stage of action to address this epidemic. thank you. >> thank you. dr. frank, we're going to try to get your testimony and then we'll run off and vote and come back. go ahead. >> chairman murphy, ranking

member degette and members of the subcommittee, thank you for the opportunity to discuss how the department of health and human services is addressing the opioid abuse epidemic. the abuse and misuse of opioids and heroin is a high priority for the hhs leadership team and we're pleased to be with you today. i'd like to give you an overview and describe how we're working to develop a multifaceted solution to this problem. it's going to take a lot of collaboration. addiction to an abuse of opioids, including both prescription painkillers and heroin and the terrible outcomes associated with them are growing at an alarming rate. just over a third of drug overdoses in 2012 and 2013 were from prescription opioids while heroin-related deaths have spiked dramatically almost tripling since 2010. the sharp abuse places a burden

on the health system. there were 259 million prescriptions filled for opioids in the u.s. in 2012. a large increase over just a few years prior. the medicare program under part d spent $2.7 billion on opioids overall in 2011. 1.9 billion, or 69%, was accounted for the top 5% opioid abusers. the cost of abuse and misuse of opioid shows up in preventible use of very expensive health care. heroin presents an equality troubling but different abuse in overdose pattern. we saw increases between 2002 and 2009 in a number of people using heroin. but that number has held fairly steady since 2009. the striking new trend is that there's an increasing share of the users that are dying from heroin overdoses. so what i'm telling you is that we have an opioid prescribing

problem sitting alongside a drug abuse and misuse problem. secretary burwell has committed to addressing the epidemic. she's driving us towards two main goals. one, reducing opioid overdoses and opioid -- and overdose-related mortality and, two, decreasing prevalence of opioid use disorder. she directed us to use the best science and to focus on the most promising levers that can make a difference for the people who struggle with opioid addiction and their families. hhs agencies have been collaborating on this problem for some time and we hope you will agree after today that the sum is -- that their hold is greater than the sum of the parts. our action informed by the evidence and discussion with states and other stakeholders fall into three general categories. one, addressing opioid prescribing practices, two, expanding the use of naloxone and, three, promoting medication-assisted treatment. let me outline the plan in a bit

more detail. first, pdmps. we're increasing investments in prescription drug monitoring programs among the most promising clinical tools to curb prescription opioid abuse. we're investing through state grants and technical assistance in supporting best practices to maximize the impact of pdmps. second naloxone, a life-saving drug that can reverse overdose from boltth prescription overdoses and heroin. we are working with state and local governments to support training and other measures that get naloxone into the hands of those that are in a position to reverse overdoses. finally, we have plans to support the appropriate use of medication-assisted treatment or m.a.t. the enactment of the addiction equity act opens new opportunities to expand access to these evidence-based treatments. we also are working on identifying best practices in

primary care settings increasing access to m.a.t. through grant support and potentially increasing the supply of m.a.t. providers by reviewing the policy and regulations of one of the types of the individuals certified to prescribe. our commitment to halting this complex public health epidemic is set out in the president's 2016 budget that includes a $99 million increase for parts of our initiative. finally, evaluation will help us identify the most effective activities allow us to continually learn and in order to address this public health concern. in closing, this is critical for hhs and for the nation and with can't do it alone. we need help. thank you for encouraging an open discussion of this today and we are committed to turning the tide on the opioid epidemic. >> thank you. now, votes are in progress. even though time is running out,

only about 20 people voted so far. so this is throwing everybody off and their schedules. i apologize. this is what happens on capitol hill. but we're committed to hear from you. we know how important this is and we value your testimony. so we're probably going to be back in a little under an hour. so we look forward to hearing from you then and getting to the rest of the testimony. thank you.

all right. thank you for being patient. all right. dr. volkow, you're recognized for five minutes. >> good morning, chairman murphy ranking member degette and other members of the subcommittee. i want to thank you for organizing and inviting me to participate in this important hearing. the known use of prescription pain relievers is a public health challenge and demands solutions on the one happened to prevent their diversions and the misuse while at the same time demands solutions that will not jeopardize access of these medications for those that need them. opioid medications are probably among the most effective painkillers that we have for the management of acute severe

pain. and the proper use can actually save lives. they act by activating opioid receptors that are located in the areas of the brain that persist pain but very high concentration of opioid receptors in brain regions and hence the problem. activation of these receptors is what is associated with the addiction potential. there are also high levels of receptors in areas of the brain that regulate breathing, which is why their use is associated also with the high risk of death from overdoses. we have heard that devastating consequences from the escalation of the abuse of prescription medications in our country the overdose deaths, the transition to injection of heroin and associated infections with hiv and hepatitis c and increasing numbers that we're seeing on the neonatal abstinence syndrome.

the role is to support the research that will help develop solutions to prevent and treat abuse of prescription medications that could be implemented now while at the same time funding research that, in the future will provide transformative solutions. there are already evidence-based practices that have been shown to be effective in the prevention of overdose deaths. that include the use of medications for opioid addiction and the use of naloxone to reverse opioid overdoses. there are three medications currently available to treat opioid medications, methadone and when used as a treatment plan have been shown to facilitate abstinence and reduce overdose and hiv infections. also when coupled to prenatal care pregnant women addicted to

opioids, these medications reduce the risk of obstetric and neonatal complications. yet, despite the strong evidence, less than 40% of those receiving treatment for opioid addiction get treated with this medication. the funding research on strategies that facilitate the use of medications for opioid addiction in the health care system. another key component to reduce overdose deaths is to expand the use of naloxone so they have partnered with pharmaceutical companies to develop user friendly effective delivery systems for naloxone that will facilitate their use by those that have be a loosely no medical training. in addition neither supports research on the treatment of pain and on the treatment of opioid addiction, they will offer new solutions for the treatment of these two disorders. examples -- for example, for the

management of pain including the development of drug combinations or new formulations with less addiction potential. the development of analgesics that do not rely on the opioid system. and the development of nonmedication interventions, such as the use of magnetic or electrical brain stimulation for pain management. examples of research on the treatment of opioid addiction includes a development of slow-release formations that need only once or once every six months dosing that would work with vaccines against heroin which will prevent the delivery of the drug into the brain hence interfering with the rewarding effects and reverse consequences. because the epidemic of prescription drug abuse results from a lack of knowledge from health care provider, the importance of developing curriculum to train both in pain

and substance abuse disorder is a priority which neither has developed in partnership with the other institutes, nih centers of excellence. there are over 24,000 deaths from opioid overdoses in 2013. 24,000. this highlights the urgency to address this epidemic. solutions are already available. the challenge is the implementation. this requires strong integration of efforts and neither will continue to work closely with other federal agencies community organizations and private industries to address this complex challenge. >> thank you. dr. throckmorton, five minutes. >> mr. chairman ranking member degette and members of the subcommittee, thank you for the opportunity to be here today to

discuss fda's role in combatting opioid abuse. our goal is to find the balance between needing to treat patients with pain and needing to reduce drug abuse and this work is being done to address other parts of the federal government and we know a successful and sustainable response must include federal and state government public health officials, opioid subscribers and researchers and manufacturers and patient organizations. for our part, fda plays a central role in the regulation and use of drugs from their discovery and throughout their marketing. for example, when fda reviews a drug for possible marketing, we also approve drug labeling, which includes approved uses of the medicine and as well as information about the safety risks. fda also follows drugs after they are marketed carefully, including opioid drugs, when necessary, this enables us to take a variety of actions to improve their safe use, such as

changes to approved labeling. the first area of fda activity i'd like to highlight is our work to support the development of abuse that make it is harder or less rewarding to abuse. while this is not a silver bullet that will reduce all abuse, they believe it can help reduce opioid abuse. to incentivize this they issued to meet with sponsors interested in developing them. to date, the fda has received some 30 investigation new drug applications from manufacturers. in addition, we have approved four opioid drugs with abuse to turn claims in their labeling. overall, we are in the early stages of their development and i am encouraged by this level of work. fda envisions a day not far in the future where they are an effective abuse reforms. next, with regard to prescribing

opioids, we know they are critical medications and they have to have high-quality education. over the past several years the fda has done several things to improve educational materials on opioids. for example, we recently finalized required changes to approve labels of the extended release long-acting opioids changing their indication to inform prescribers that these drugs should only be used for pain severe enough to require daily around the clock treatment when alternative treatments would not work. at the same time, fda strengthened significantly the opioids and we want prescribers to use them with care and today it's among the most restrictive of any drugs that we have in the center. and have clear language that calls attention to the potentially life-threatening risks. the fda is working to approve the information available for prescribers in other ways. under certain circumstances fda

can require manufacturers as a part of the risk evaluation and mitigation strategy to address safety concerns such as opioid abuse. in 2012, fda required manufacturers to fund the development of unbiased continuing education programs on opioid prescribing practices for prescribers. in the first year since that program has been in place, approximately 6% of the 320,000 prescribers, around 20,000 prescribers have completed one of those courses. we believe this training for prescribers is important. we also support mandatory education for prescribers of opioids as called for by the administration in the 2011 prescription drug abuse plan and re-empathized in the 2014 drug-control strategy. finally, fda has been working with many other stakeholders, including the agencies here today, to explore the best ways to prevent overdose deaths by the expanded use of naloxone. as others have said, it can and

does save lives. fda is working to facilitate the development of naloxone formulations that could be easier used by anyone responding to an overdose. first, fda meets with manufacturers whenever needed and is using whatever tools we can to expedite product development. we approved the formulation of naloxone, which is intended to be a administered by people witnessing an overdose such as family members and caregivers. we've approved this product in 15 weeks. going forward, we will work on how best to use naloxone and the fda and many other agencies are planning a public meeting in july to deal with questions of access and state and local best practices. in conclusion, as a society, we face an ongoing challenge and a dual responsibility. we must balance efforts to address opioid drug misuse abuse and addiction for need for access to appropriate pain

management. these are not simple issues and there are no easy answers. the fda is taking important actions that we hope will achieve this balance. we welcome the opportunity to work with congress, our federal partners, the medical community advocacy organizations and the multitude of interested communities and families to turn the tide on this devastating epidemic. thank you for this opportunity to testify. i look forward to answering any questions that i can. >> thank you. >> chairman murphy, ranking member degette, i'd like to thank you for inviting me here to discuss this very important issue. i'd like to thank the committee for opioid prescription abuse. i'm the director of the national center prevention and control at the cdc. as a trained emergency room physician, i have seen firsthand the devastating impact of opioid addiction on individuals and their families as well as the importance of prevention. together, we have witnessed a deadly epidemic unfolding in

states and communities across the country. the overdose epidemic is driven in large part by fundamental changes in the way that health care providers prescribe opioid pain relievers. enough prescriptions were filled in 2012 for every adult to have their own bottle of pills. as the amount increased so has the number of deaths. an alignment with the department initiative, i want to highlight cdcs work in developing opioid prescribing guidelines for chronic pain and providing direct support to states to implement multisector prevention programs. cdc is currently developing guidelines for prescribing of opioids for noncancer pain. this undertaking is responsive to a critical need in the field. these guidelines will redefine best practices for chronic pain and make important advances in protecting patients. the audience for these

guidelines are primary care practitioners who account for the number of prescriptions for opioids compared to other specialties the guidelines process is under way and public comment by the end of this year. we have plans in place to encourage uptake and usage of the guidelines among providers which is key for prescribing practices. the second activity i'd like to highlight is our major investment and state level prevention. states are at the front lines of this public health issue. and cdc is committed to equipping them with the expertise they need to reverse the epidemic and protect their communities. utilizing the newly appropriate $20 million, we recently published a new funding opportunity called prescription drug overdose prevention for states. it builds upon existing cdc-funded state programs and targets states that have a high drug overdose burden and those that demonstrate readiness needed to combat the epidemic. it requires collaboration across

sectors for a truly comprehensive response. the goals for this program are to make prescription drug monitoring programs more timely easier to use and able to communicate with other state pdmps. to implement medicaid or workers compensation prevention and data driven prevention to the community struggling with the highest rates of drug abuse and overdose. states also will be given the flexibility to use the program to respond to emerging crises so they know what works to prevent overdose and save lives in their community. the development opioid prescribing guidelines and our state prevention program are two key ways that cdcs broad work contributes to the initiative. we're examining overdose heroin doubled since 2010 and prescription opioid abuse a key

risk factor for heroin use, has contributed significantly to this rise in heroin use and overdose. we will leverage our scientific expertise to improve public health surveillance of heroin and evaluate effective strategies to prevent future heroin overdoses. addressing this complex problem requires a multifaceted approach and collaboration among a variety of stakeholders. but it can be accomplished. particularly with the ongoing efforts of all of the organizations represented here on this panel. cdc is committed to tracking and understanding the epidemic supporting states working on the front line of this cry saysises and pro i had vooing providing the tools and guidance. thank you again for the opportunity to be here with you today and for your continued work and support of us protecting the public's health. i look forward to your questions. >> thank you doctor.

welcome back. >> good morning, chairman murphy ranking member degette. thank you for inviting samsa to be part of this hearing. according to samsa's national survey, the nonmedical use of prescription opioids is high, approximately 4.5 million individuals in 2013. heroin use is much lower about 289,000 individuals reporting past month use but that's doubled in five years. fortunately, the nonmedical use of pain relievers has decreased some from 2009 to 2013, especially among young people ages 12 to 17. however, as you know overdoses and overdose-related deaths from prescription death and heroin has risen dramatically among all ages. few who need treatment are receiving the community-based services that they need free of addiction.

samsa believes recovery is the goal. the data and public education and regulatory efforts are all designed to prevent overdoses help provide the treatment and services needed for people with substance abuse disorders to achieve recovery support their families and foster support of communities. samsa together with six other medical societies to train prescribers with the best approach to pain management. the addiction technology transfer centers provide training and materials on opioid abuse disorders to distribute research-based best practices to the treatment field. to help prevent opioid related deaths, the funds may be used to purchase and distribute naloxone and increase training on its use. also in 2014, they updated their opioid overdose prevention tool kit to education individuals, families and first

responders and others about steps to prevent and reverse the effects of opioid overdoses, including the use of naloxone. this tool kit is one of the most downloaded resources on the website. the president's 2016 budget includes $12 million in discretionary budget for states to deliver naloxone in high-risk communities and distribute education for overdose prevention strategies. as part of a recovery-oriented care model, medical assisted treatment is not meant as a stand alone approach but rather is designed to include medication, counselling, behavioral therapies and recovery support. in march 2015 samsa revised guidelines for opioid treatment programs to highlight the care model and encourage the use of any of the three fda-approved medications for the treatment of opioid abuse disorder based on an assessment of the needs. they are taking an integrated

care approach as part of the new 2015 grant program to expand and enhance the availability of medication assisted treatment and other clinically appropriate with states with the highest rates of opioid admissions. the president's 2016 budget proposes to double this program. in collaboration with doj, samsa added language to the grant requirements to make sure that drug court do not have to stop the prescription as part of a regulated opioid treatment program. samsa regulates the treatment programs which are expected to provide a full range of services for their patients. in collaboration with a drug enforcement administration, samsa provides treatment in a practice setting other than in an opioid treatment program. we fund efforts to help prevent

prescription abuse and heroin use. for example, in 2014 samsa strategic framework partnerships for success program made preventing and reducing heroin use one of its focus areas along with prescription drug misuse and abuse and underage drinking. the president has proposed $10 million for the framework rx to help states use data, including pdmp data to identify and assist the nonuse of drugs. we want to thank you again for taking on this issue and allowing samsa to share its efforts with you and we look forward to answering your questions. >> dr. conway, you're recognized for five minutes. >> chairman murphy and ranking member degette and members of the subcommittee, thank you for inviting me to discuss the situation preventing prescription drug abuse.

as we heard from other witnesses, they have been implicated in drug deaths in the last decade. as a practicing physician i understand the importance of this issue. cms recognized the responsibility of ensuring appropriate safeguards are in place to prevent overuse. ensuring they can access needed medications and treatments for substance abuse disorder. since inception in 2006, medicare part d prescription drug benefit made medicines more available and affordable leading to improvement in access to prescription drugs. despite successes part d is not immune from the nationwide epidemic of opioid abuse. cms is trying to address potential fraud by making sure they have coverage for drug therapies that meet safety and

efficacy standards. we believe that will protect beneficiaries of damaging echkts associated with prescription drug abuse and to prevent overutilization. the strategy is to monitor part d drug utilization management programs to prevent overutilization of medications. to accomplish this goal the medicare part d overutilization monitoring system or oms was implemented in 2013. through this system cms provides reports to sponsors on beneficiaries with potential opioid overutilization identified through analysis of prescription druggy vent data and through beneficiaries for the cms program for integrity. sponsors are expected to utilize various drug utilization monitoring tools to revent continued overutilization of opioids. from 2011 to fourth they reduced

users by 26%. they use medic charged with investigating fraud and abuse, developing cases for referral to law enforcement agencies. in 2013, cms directed the medic to address drug analysis. creating new tools against problematic prescribers and pharmacies. we finalized a provision that requires providers to enroll or have an opt out affidavit on file and establishes ref indication authority for abusing prescribing patterns. state medicaid agencies have taken action to attack that epidemic. efforts include expanding medicine dade to include behavioral health service for those addicted to drugs and pharmacy management review programs. cms are encouraged by states

effected strategies tore designing benefits for the population. we launched the accelerator program to provide states with technical assistance and other support to address this important issue. cms in coordination with cdc and nih, issued informational bulletin on medication assisted treatment for substance abuse disorder in the medicaid program. it outlined that medication and behavioral therapies is the most effective combination of treatment. issued a similar bulletin focused on these services in pediatric and youth population. cms is dedicated to providing the best care to beneficiaries with opioid addiction. working with state medicare programs to have safeguards to prevent the abuse and treat them effectively. we have made progress but there's more work to be done. they're taking mumt am interventions to reduce the addiction and overdoses and medicare and medicaid.

previous testimonies i have never had family here or time to thank them. i want to thank my mother diane conway is here, my son jack who is out of school as well as my wonderful wife heather, daughters alexa and savannah. and without their love and support, i would not be able to work on issues like this. they're critically important to our nation so thank you. >> thank you, doctor, thank you for recognizing to take your family to testifying day. apparently everybody else didn't get the memo. i just want to start by saying if talents and dedication alone could solve this crisis, we'd be there with the dependent of today and other days. obviously we still have problems. let me start by asking a few questions. for the director, office of national control policy uses the term recovery, does it mean to include patients with opioid addiction in buprenorphine or

methadone treatment program still using heroin or illicit drugs or would you say that's not recovery. >> from our perspective and as a person in recovery, clearly we want to make sure that people are continuing to progress in recovery, free from substances is the ultimate goal of recovery programs. i think everyone would agree on that. we also know that substance use, particularly opioid use disorders are a significant chronic disorder and that often times and even my own experience show me that people often will experience relapse and will often need multiple attempts at treatment to get to that final goal of long term recovery and long term abstinence. we want to be sure we are continuing to engage with patients, that we are moving them toward better health, better recovery and being free from substance use as part of long term recovery. >> let me ask miss con tee this, we heard last week there was not uniform definition of recovery.

this is the talent pool, you're the ones that do these. do you all meet on a regular basis to talk about these issues? when was the last time you got together to talk policy issues, pam? >> let me start. >> you'll start. >> let me start. it is actually part of our statutory authority that we set in conjunction not just with hhs but all federal agencies that have a role in substance use and opioid use disorders. we have been engaged with dod, va, bureau of prisons. >> you meet regularly? >> we do. we have quarterly meetings. >> let me move on that too. that's important. miss hyde let me ask you in response to our bipartisan letter of march 18th concerning the national registry of evidence based programs you noted that, quote, new submission and review procedures will improve rigor of registry and bring into closer alignment

of other evidence based programs in the federal government. prior to entering into the july 2014 contract, did samhsa feel it needed strengthened? yes or no. do you feel it needed to be strengthened? >> thank you for the question. we thought the process we used for determining what practices were reviewed needed to be strengthened, and in the process we have also increased the rigor with which we look at them. >> can you give us a list of what you consider to be models in the federal registry we can review as part of that as evidenced based programs? >> certainly. >> thank you. your response also indicates an outside contractor will assume role of gate keeper determining which studies and outcomes are reviewed in the screening and review of an intervention with aim of preventing bias in the developers. was samhsa's prior system for selecting interventions prone to

any kind of bias or conflict of interest was that a concern? >> yes, mr. murphy, it was a concern. it was pretty much developer driven so a developer had to want their practice to be reviewed. then they had some control over what research we looked at. we changed that with the new contract that began last year and we will help decide priorities together with public input, but the contractor will help us look more objectively at evidence. >> thank you. just hold up. i got a note, an article, is this one of your constituents from eastern colorado? i don't want to take your colorado thunder a fascinating article. made reference to the increase use of emergency departments with opioids. they said that's 10.5 million with this is probably an underestimate, that people go to

emergency rooms for treatment for withdrawal, but also many trying to get more opioids. when you have users with prescriptions from more than one physician, they're more likely to be involved in riskier practices. could any of you comment on that's an area we are addressing? some of you comment on the issues? >>. >> yes the article, referring to new england journal of medicine article that shows there's been a very significant quadruple number of cases in intensive care units. this does reflect the fact that there are many women being prescribed opioid medications during the pregnancy itself and based on another study was estimated 21% of women that are pregnant are going to receive an opioid medication, which again

highlights the need to enforce bertha guidelines on management of pain need to be enforced in better ways. there's a study that evaluated the extent that physicians are following guidelines by the main medical organizations as relates to management of pain. that's an area where there needs to be an aggressive increase in education and enforcement of guidelines. >> thank you. i am out of time. i ask unanimous consent to submit for the record. >> thank you, mr. chairman. doctor, as i mentioned in opening statement, you're one of the world's top experts on the issue of treating addiction. briefly, what does the body of scientific evidence show regarding effect i haveness of met doen