AUTHORITYID | CHAMBER | TYPE | COMMITTEENAME |
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hswm00 | H | S | Committee on Ways and Means |
[House Hearing, 115 Congress] [From the U.S. Government Publishing Office] ``THE OPIOID CRISIS: THE CURRENT LANDSCAPE AND CMS ACTIONS TO PREVENT OPIOID MISUSE'' ======================================================================= HEARING before the SUBCOMMITTEE ON OVERSIGHT of the COMMITTEE ON WAYS AND MEANS U.S. HOUSE OF REPRESENTATIVES ONE HUNDRED FIFTEENTH CONGRESS SECOND SESSION __________ JANUARY 17, 2018 __________ Serial No. 115-OS10 __________ Printed for the use of the Committee on Ways and Means [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT] ______ U.S. GOVERNMENT PUBLISHING OFFICE 33-659 WASHINGTON : 2019 COMMITTEE ON WAYS AND MEANS KEVIN BRADY, Texas, Chairman SAM JOHNSON, Texas RICHARD E. NEAL, Massachusetts DEVIN NUNES, California SANDER M. LEVIN, Michigan DAVID G. REICHERT, Washington JOHN LEWIS, Georgia PETER J. ROSKAM, Illinois LLOYD DOGGETT, Texas VERN BUCHANAN, Florida MIKE THOMPSON, California ADRIAN SMITH, Nebraska JOHN B. LARSON, Connecticut LYNN JENKINS, Kansas EARL BLUMENAUER, Oregon ERIK PAULSEN, Minnesota RON KIND, Wisconsin KENNY MARCHANT, Texas BILL PASCRELL, JR., New Jersey DIANE BLACK, Tennessee JOSEPH CROWLEY, New York TOM REED, New York DANNY DAVIS, Illinois MIKE KELLY, Pennsylvania LINDA SANCHEZ, California JIM RENACCI, Ohio BRIAN HIGGINS, New York PAT MEEHAN, Pennsylvania TERRI SEWELL, Alabama KRISTI NOEM, South Dakota SUZAN DELBENE, Washington GEORGE HOLDING, North Carolina JUDY CHU, California JASON SMITH, Missouri TOM RICE, South Carolina DAVID SCHWEIKERT, Arizona JACKIE WALORSKI, Indiana CARLOS CURBELO, Florida MIKE BISHOP, Michigan DARIN LAHOOD, Illinois David Stewart, Staff Director Brandon Casey, Minority Chief Counsel ______ SUBCOMMITTEE ON OVERSIGHT LYNN JENKINS, Kansas, Chairman DAVID SCHWEIKERT, Arizona JOHN LEWIS, Georgia JACKIE WALORSKI, Indiana JOSEPH CROWLEY, New York CARLOS CURBELO, Florida SUZAN DELBENE, Washington MIKE BISHOP, Michigan EARL BLUMENAUER, Oregon DARIN LAHOOD, Illinois TOM REED, New York C O N T E N T S __________ Page Advisory of January 17, 2018, announcing the hearing............. 2 WITNESSES Gary L. Cantrell, Deputy Inspector General for Investigations, Office of the Inspector General, Department of Health and Human Services (HHS)................................................. 6 Elizabeth H. Curda, Director, Health Care, Government Accountability Office (GAO).................................... 18 Kimberly Brandt, Principal Deputy Administrator for Operations, Centers for Medicare & Medicaid Services (CMS)................. 35 QUESTIONS FOR THE RECORD Questions from the Hon. Lynn Jenkins, Chairman of the Subcommittee on Oversight of the Committee on Ways and Means, to Kimberly Brandt, Principal Deputy Administrator for Operations, Centers for Medicare & Medicaid Services (CMS)..... 80 Questions from Representative Jackie Walorski, 2nd District of Indiana, to Kimberly Brandt, Principal Deputy Administrator for Operations, Centers for Medicare & Medicaid Services (CMS)..... 81 Questions from Representative Patrick Meehan, 7th District of Pennsylvania, to Kimberly Brandt, Principal Deputy Administrator for Operations, Centers for Medicare & Medicaid Services (CMS)................................................. 87 Questions from Representative Joseph Crowley, 15th District of New York, to Kimberly Brandt, Principal Deputy Administrator for Operations, Centers for Medicare & Medicaid Services (CMS). 88 Questions from the Hon. Lynn Jenkins, Chairman of the Subcommittee on Oversight of the Committee on Ways and Means, to Elizabeth H. Curda, Director, Health Care, Government Accountability Office (GAO).................................... 89 Questions from Representative Joseph Crowley, 15th District of New York, to Elizabeth H. Curda, Director, Health Care, Government Accountability Office (GAO)......................... 91 Questions from the Hon. Lynn Jenkins, Chairman of the Subcommittee on Oversight of the Committee on Ways and Means, to Gary L. Cantrell, Deputy Inspector General for Investigations, Office of the Inspector General, Department of Health and Human Services (HHS)................................ 92 Questions from Representative Patrick Meehan, 7th District of Pennsylvania, to Gary L. Cantrell, Deputy Inspector General for Investigations, Office of the Inspector General, Department of Health and Human Services (HHS)................................ 94 Questions from Representative Joseph Crowley, 15th District of New York, to Gary L. Cantrell, Deputy Inspector General for Investigations, Office of the Inspector General, Department of Health and Human Services (HHS)................................ 95 SUBMISSIONS FOR THE RECORD American Association of Nurse Anesthetists (AANA)................ 97 Abuse Deterrent Coalition (ADC).................................. 103 Nola, a Concerned American Citizen............................... 109 Halyard Health................................................... 111 Premier healthcare alliance...................................... 115 Quest Diagnostics Incorporated................................... 118 ``THE OPIOID CRISIS: THE CURRENT LANDSCAPE AND CMS ACTIONS TO PREVENT OPIOID MISUSE'' ---------- WEDNESDAY, JANUARY 17, 2018 U.S. House of Representatives, Committee on Ways and Means, Subcommittee on Oversight, Washington, DC. The Subcommittee met, pursuant to call, at 10:00 a.m., in Room 1100, Longworth House Office Building, Hon. Lynn Jenkins [Chairman of the Subcommittee] presiding. [The advisory announcing the hearing follows:] ADVISORY FROM THE COMMITTEE ON WAYS AND MEANS SUBCOMMITTEE ON OVERSIGHT CONTACT: (202) 225-1721 FOR IMMEDIATE RELEASE Wednesday, January 17, 2018 OS-10 Chairman Brady Announces Oversight Subcommittee Hearing on ``The Opioid Crisis: The Current Landscape and CMS Actions to Prevent Opioid Misuse'' House Ways and Means Committee Chairman Kevin Brady (R-TX), announced today that the Oversight Subcommittee will hold a hearing on ``The Opioid Crisis: The Current Landscape and CMS Actions to Prevent Opioid Misuse.'' The hearing will focus on efforts by the Centers for Medicare & Medicaid Services (CMS) to utilize data to identify individuals in the Medicare Part D program who are at risk to abuse opioids. The hearing also will examine the extent of the problem as well as the tools CMS has available to prevent individuals from receiving unnecessary opioids. The hearing will take place on Wednesday, January 17, 2018, in room 1100 of the Longworth House Office Building, beginning at 10:00 a.m. In view of the limited time to hear witnesses, oral testimony at this hearing will be from invited witnesses only. However, any individual or organization may submit a written statement for consideration by the Committee and for inclusion in the printed record of the hearing. DETAILS FOR SUBMISSION OF WRITTEN COMMENTS: Please Note: Any person(s) and/or organization(s) wishing to submit written comments for the hearing record must follow the appropriate link on the hearing page of the Committee website and complete the informational forms. From the Committee homepage, http:// waysandmeans.house.gov, select ``Hearings.'' Select the hearing for which you would like to make a submission, and click on the link entitled, ``Click here to provide a submission for the record.'' Once you have followed the online instructions, submit all requested information. ATTACH your submission as a Word document, in compliance with the formatting requirements listed below, by the close of business on Wednesday, January 31, 2018. For questions, or if you encounter technical problems, please call (202) 225-3625. FORMATTING REQUIREMENTS: The Committee relies on electronic submissions for printing the official hearing record. As always, submissions will be included in the record according to the discretion of the Committee. The Committee will not alter the content of your submission, but we reserve the right to format it according to our guidelines. Any submission provided to the Committee by a witness, any materials submitted for the printed record, and any written comments in response to a request for written comments must conform to the guidelines listed below. Any submission not in compliance with these guidelines will not be printed, but will be maintained in the Committee files for review and use by the Committee. All submissions and supplementary materials must be submitted in a single document via email, provided in Word format and must not exceed a total of 10 pages. Witnesses and submitters are advised that the Committee relies on electronic submissions for printing the official hearing record. All submissions must include a list of all clients, persons and/or organizations on whose behalf the witness appears. The name, company, address, telephone, and fax numbers of each witness must be included in the body of the email. Please exclude any personal identifiable information in the attached submission. Failure to follow the formatting requirements may result in the exclusion of a submission. All submissions for the record are final. The Committee seeks to make its facilities accessible to persons with disabilities. If you are in need of special accommodations, please call 202-225-1721 or 202-226-3411 TDD/TTY in advance of the event (four business days notice is requested). Questions with regard to special accommodation needs in general (including availability of Committee materials in alternative formats) may be directed to the Committee as noted above. Note: All Committee advisories and news releases are available at http://www.waysandmeans.house.gov/Chairman JENKINS. The Subcommittee will come to order. Welcome to the Ways and Means Oversight Subcommittee Hearing on the Opioid Crisis, the Current Landscape and CMS Actions to Prevent Opioid Misuse. Good morning. I want to thank the panel for coming and welcome you all to today's hearing, the Opioid Crisis, the Current Landscape and CMS Actions to Prevent Opioid Misuse. Opioid abuse has devastated communities across America. In 2016, more than 42,000 Americans died due to opioids, a level that is five times what it was in 1999. My home State of Kansas is no exception. In 2000, 35 overdose deaths were attributed to opioids. In 2016, 159 people died from opioid abuse in Kansas. Overdose deaths in America are on the rise largely due to opioids, which account for three out of every five overdose deaths. These numbers are startling, and yet many experts believe they are too low. And, unfortunately, this epidemic continues to get worse, which is why finding ways to address the problem is a high priority for this Committee. No community is immune to the effects of opioid abuse. Rural communities are hit particularly hard, as they often have limited access to critical services and resources to support those struggling with addiction. The immense cost opioids impose on society as a whole cannot be overstated. According to the Centers for Disease Control, opioids imposed an economic burden of $78.5 billion in 2013. Much of this is due to increased substance abuse treatment cost, lost productivity, incarceration, and other burdens put on the criminal justice system. Last year, the President's Council of Economic Advisors estimated the cost to be even higher. In order to address the opioid crisis, we need to understand what the current state of the problem is. We also need to understand what tools are in place to address this problem and how they can be improved. Today we will examine how the Centers for Medicare & Medicaid Services, or CMS, is working to address opioid misuse in the Medicare Part D program. More than 42 million beneficiaries rely on the program for prescription drugs, including opioids. It is critical that Medicare and private Part D plan sponsors have the tools they need to ensure that opioids are provided only when medically necessary. We have a panel of experts that can talk about what CMS and the plan sponsors are doing to identify those most at risk so that appropriate interventions can be taken. Our witnesses today should provide the Committee with valuable insights into how things are currently working and what can be done to improve them. The Committee plans to do more oversight on this issue as we continue to examine other ways to reduce opioid abuse. Before closing, I want to recognize that a lot of what we will be discussing today will be sanitized to some degree, simply through the use of numbers and statistics. I would like the record to reflect that the Members of this Committee know that there are real people, real families, and real experiences behind every number. That is why we are here today and we are devoting time to such a critical issue. With that, I want to thank our witnesses, and I look forward to their testimony. I now yield to the distinguished Member from Washington, Ms. DelBene, for the purposes of an opening statement. Ms. DELBENE. Thank you, Madam Chair. And thank you for holding this important hearing. I would like to thank our witnesses also for taking the time to be with us here today. And I would like to acknowledge our Ranking Member, Neal, and thank him for being here today and joining us. But I want to start by congratulating our new Chair of the Subcommittee on Oversight. Clapping is appropriate. No, no, I said that is good. I know you are a certified public accountant, and were the 37th Kansas State Treasurer, both of which will be valuable for this Subcommittee in particular, as we look at IRS reforms. I look forward to working with you on this and other things that are under the Subcommittee's jurisdiction, and I hope we'll continue to work in a bipartisan fashion on issues that are important to all of us, just like today's topics. So, thank you very much, and welcome to your new role. And I yield back. Chairman JENKINS. Thank you. I now yield to the distinguished Ranking Member of the Full Committee, Mr. Neal, for the purposes of a statement. Mr. NEAL. Thank you, Madam Chairperson. Everyone in this room has a family member or knows someone directly impacted by the opioid epidemic, somebody down the street, a neighbor, or we have all witnessed wrenching consequences of what this has done to families across the country. In Massachusetts, there were 2,094 confirmed opioid-related overdose deaths in 2016. Although overdose rates are highest for people 25 to 54, this public health emergency also affects Medicare beneficiaries. According to a study recently from Altarum in November of 2017, the economic burden from opioids was estimated to be $95 billion in 2016, $21 billion of which was attributed to healthcare services, direct and indirect cost, and $55.6 billion lost to earnings and productivity. In 2016, one-third of Medicare Part D beneficiaries filled a prescription for opiates. For one-third of these beneficiaries, we know part of the consequence. This number is too high and we need to explore better ways to manage chronic pain. I hope that we can work in a bipartisan manner to urge the Centers for Medicare & Medicaid Services to move quickly to implement recommendations. Congress and the Administration need to do more to help Americans access necessary treatment for opioid use disorders. The Administration's emergency declaration expires next week, but nothing at the moment has progressed. Yet, another missed opportunity for positive action. The most significant step that has been taken in recent years to stem the tide of the opioid crisis has been to expand Medicaid under the ACA to low-income working Americans who previously could not afford insurance. The Medicaid expansion has provided millions of previously uninsured adults with access to health insurance, which includes coverage for substance abuse and mental health services. For Medicare, the specific topic of today's hearing, we need to look to beneficiary's ability to access treatment, as oftentimes providers aren't available to meet the need. We know there are significant groups and gaps in the coverage and access under Medicare that need to be acknowledged. For example, Medicare does not cover outpatient treatment programs that provide comprehensive opiate addiction treatments, nor does Medicare cover methadone for addiction, which is often the treatment of choice for long term addicts. We clearly have our work to do this year, and we need to stop undermining the programs that provide coverage and treatment for those who need it, instead, strengthening and improving access to care and coverage. And another reflection, just off the talking points. What this has done to labor participation rates across the country is an underreported story. When the Department of Labor recently indicated that there are six million jobs in America every day that go unanswered, and when you consider that there are two million people with opiate addictions that are sitting on the sidelines who could be working, that is another consequence of what has happened. A number of people across America, who have opiate addictions, who are sitting home in the afternoon playing video games rather than in the workforce, ought to alarm all of us, and there ought to be something that we can all agree to in terms of the treatment needs of those very people. But this has a personal consequence for all of us as well, as I indicated in the first sentence. We all have a neighbor, friend, or a relative who is battling this addiction. And this ought to be well beyond the consequence of partisanship in this institution. We ought to be trying to find some remedies. And I yield back my time. Chairman JENKINS. Thank you, Mr. Neal. Without objection, other Members' opening statements will be made part of the record. Today's witness panel includes three experts: Gary L. Cantrell, Deputy Inspector General for Investigations at the Department of Health and Human Services Office of the Inspector General; Elizabeth H. Curda, Director of Health Care at the Government Accountability Office; and Kimberly Brandt, Principal Deputy Administrator for Operations at the Centers for Medicare & Medicaid Services. The Subcommittee has received your written testimonies, and they will be made part of the formal hearing record. You each have 5 minutes to deliver your oral remarks. We will begin with you, Mr. Cantrell. You may begin when you are ready. STATEMENT OF GARY L. CANTRELL, DEPUTY INSPECTOR GENERAL FOR INVESTIGATIONS, OFFICE OF THE INSPECTOR GENERAL, DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Mr. CANTRELL. Thank you. Good morning, Chairman Jenkins and Ranking Member Neal, and other distinguished Members of the Subcommittee. I am Gary Cantrell, Deputy Inspector General for Investigations at HHS OIG, and I am excited to be here today to discuss efforts by the HHS OIG to combat the opioid epidemic in Federal healthcare programs. Given a long history of healthcare fraud enforcement, program knowledge, and data analytics capabilities, OIG is uniquely positioned to help lead this fight against illegal opioid prescribing in Medicare and Medicaid. My testimony today will highlight our work to prevent opioid-related fraud and abuse, detect questionable prescribing and billing patterns, and enforce laws and regulations governing opioid prescribing. Opioid-related fraud encompasses a broad range of criminal activity, from prescription drug diversion to addiction treatment fraud. Many of these schemes involve kickbacks, medical identity theft, and criminal enterprises. Developing these investigations is complex, requiring the use of confidential informants, undercover operations, and surveillance to gather evidence of crimes often committed by corrupt doctors, pharmacists, and criminal networks. In the worst cases, our special agents uncover evidence of illegal prescribing leading to patient deaths. Given the complexity and high stakes of these investigations, OIG's partnerships with DOJ, FBI, DEA, and State Medicare fraud control units is critical to the success of these efforts. OIG and our Medicare Fraud Strike Force partners led the 2017 national healthcare fraud take-down. This take-down was the largest ever healthcare fraud take-down, resulting in over 400 individuals charged; 120 of these defendants were charged for their roles in illegally prescribing and distributing opioids. The enforcement operation brought together more than 1,000 Federal and State law enforcement personnel, including 350 OIG special agents. OIG has also shifted resources to support the Attorney General's Opioid Fraud and Abuse Detection Unit, a multiagency effort capitalizing on data, with dedicated prosecutors and agents focused solely on prosecuting opioid fraud in the healthcare system. OIG uses advanced data analytics to put timely, actionable information about prescribing, billing, and utilization trends in the hands of investigators, auditors, evaluators, and our government partners. A recent report identifying Medicare beneficiaries receiving extremely high amounts of opioids and questionable prescribing patterns demonstrates the value of this approach. Of note, the report uncovered that half a million Medicare beneficiaries received opioids in excess of CDC guidelines. Further, nearly 90,000 beneficiaries are at serious risk of opioid misuse or overdose. Some of these received extreme amounts of opioids, over 2\1/2\ times the CDC recommended amounts, when others appear to be doctor shopping. To get to the source of this extreme use, OIG identified about 400 prescribers with questionable opioid prescribing patterns for these beneficiaries at serious risk. OIG is following up on these outlier prescribers, and we have also shared this data with our public and private sector partners. This is one example of how we leverage our relationships and empower our partners to help us tackle this problem. Recognizing the growing severity of the opioid epidemic, OIG has initiated work beyond Medicare. The work identifies opportunities to strengthen program integrity and protect at- risk beneficiaries across multiple HHS programs. For example, OIG audits and evaluations currently underway address the broad range of opioid-related funding and activity at HHS, including opioid prescribing in Medicaid, transfer prescription drug monitoring programs, FDA's oversight of opioid risk management program and addiction treatment services. OIG's work holds criminals accountable and results in impactful recommendations to improve program integrity, save tax dollars, and protect HHS beneficiaries from harm. Key recommendations to combat opioid-related fraud and abuse are outlined in my written testimony. In summary, OIG will continue to focus our multidisciplinary efforts on the opioid epidemic. We will identify opportunities to improve HHS prescription drug and treatment programs, share data and educate the public, and identify and hold accountable perpetrators of opioid-related fraud. I appreciate the opportunity to speak with you today, and I would be happy to answer any questions. [The prepared statement of Mr. Cantrell follows:] [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT] Chairman JENKINS. Thank you, Mr. Cantrell. Ms. Curda, you are recognized for 5 minutes. STATEMENT OF ELIZABETH H. CURDA, DIRECTOR, HEALTH CARE, GOVERNMENT ACCOUNTABILITY OFFICE (GAO) Ms. CURDA. Good morning, Chairman Jenkins, Ranking Member Neal, and Members of the Subcommittee. I am pleased to be here to discuss our report on the Centers for Medicare & Medicaid Services oversight of opioid prescribing in the Medicare program. Overprescribing and misuse of prescription opioids has led to significant increases in opioid use disorder, overdoses, and deaths in the United States. Recognizing this, CMS developed an opioid misuse strategy with a goal to reduce harm from opioid misuse in its programs. Today I will discuss how CMS oversees opioid prescribing under Medicare Part D, both in terms of the beneficiaries who receive opioid prescriptions, as well as the providers who prescribe them. To oversee beneficiaries, CMS relies on private insurers, known as plan sponsors, to monitor and take appropriate action to address potential opioid overuse. CMS employs an overutilization monitoring system to alert plan sponsors about very high-risk beneficiaries. These are beneficiaries receiving high doses of opioids from four or more providers and pharmacies or from six or more providers regardless of the number of pharmacies. Excluding cancer and hospice care, about 33,000 beneficiaries met these criteria in 2015. Plan sponsors are expected to review a quarterly list of identified beneficiaries, determine appropriate action, and then respond to CMS with information on their actions within 30 days. The use of these criteria, along with plan sponsor actions, has helped to significantly reduce the number of these very high-risk cases. However, CMS oversight does not address the over 700,000 beneficiaries potentially at risk of harm, based on CDC guidelines. These guidelines note that long-term use of opioid doses over 90 milligrams morphine equivalent per day are associated with significant risk of harm and should be avoided unless a provider determines that it is necessary. This is particularly the case for patients aged 65 and older, because the drugs can more easily accumulate in the body to toxic levels. We recommended that CMS gather information on the total number of these beneficiaries over time to help assess progress in reaching the agency's goals related to reducing opioid harm and misuse. HHS concurred with our recommendation. CMS oversees Medicare Part D providers through its contractor, NBI MEDIC, as well as through the plan sponsors. NBI MEDIC provides oversight by analyzing Medicare prescriber data for outliers and determining potential fraud. NBI MEDIC conducts its own investigations of potential fraud, waste, and abuse by providers, and also refers cases to law enforcement or the Office of the Inspector General. CMS also requires plan sponsors to prevent, detect, and correct prescriber noncompliance, as well as fraud, waste, and abuse. However, NBI MEDICS analyses to identify outlier providers focused broadly on all drugs at risk of abuse, rather than on opioids specifically. We recommended that CMS require NBI MEDIC to gather separate data on providers who prescribe high amounts of opioids. This would allow CMS to better identify those providers who are inappropriately and potentially fraudulently prescribing high doses of opioids. HHS concurred with this recommendation as well. CMS also lacks key information necessary for oversight of opioid prescribing because it does not require plan sponsors to report cases of fraud, waste, and abuse, cases of overprescribing, or any actions taken against providers. While CMS received some of this information from plan sponsors who voluntarily report their actions, it does not know the full extent to which plan sponsors have identified providers who prescribe high amounts of opioids or take an appropriate action. We recommended that CMS require plan sponsors to report on investigations and other actions taken related to providers who prescribe high amounts of opioids. HHS did not concur, noting that plan sponsors are responsible for detecting and preventing fraud, waste, and abuse, and that CMS reviews cases when it conducts audits. HHS also stated that it seeks to balance the requirements it places on plan sponsors. However, without complete reporting, CMS is missing key information that could help the agency achieve its goals. We continue to believe that CMS should require plan sponsors to report on the actions they take to reduce overprescribing. In conclusion, having information on the total number of beneficiaries receiving potentially harmful levels of opioid medication, as well as complete information on providers who may be inappropriately prescribing opioids, could help CMS as it works to decrease the risk of opioid use disorder, overdoses, and deaths. This concludes my prepared statement, and I am happy to answer the Committee's questions. [The prepared statement of Ms. Curda follows:] [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT] Chairman JENKINS. Thank you, Ms. Curda. Ms. Brandt, you are recognized for 5 minutes. STATEMENT OF KIMBERLY BRANDT, PRINCIPAL DEPUTY ADMINISTRATOR FOR OPERATIONS, CENTERS FOR MEDI- CARE & MEDICAID SERVICES (CMS) Ms. BRANDT. Thank you. Chairman Jenkins, Ranking Member Neal, and Members of the Subcommittee, thank you for inviting me to discuss CMS's work to address the misuse of opioids in the Medicare Part D program. CMS understands the magnitude and impact the opioid misuse epidemic has had on our communities and is committed to a comprehensive and multipronged strategy to combat this public health emergency. As Principal Deputy for Operations at CMS, I am charged with directing cost-cutting issues that affect all of our programs, with the efforts to fight the opioid epidemic being one of our agency's biggest priorities. We cover over 58 million Medicare beneficiaries, and the opioid epidemic affects every one of them as a patient, family member, caregiver, or community member. CMS recognizes that its primary role in the healthcare system is that of a payer. And as a payer, we are focused on the unique steps we can take to ensure that plans comply with requirements that protect beneficiaries. For us, all of our efforts are ultimately focused on protecting the health and safety of our Medicare beneficiaries. Due to the structure of the Medicare Part D program, Medicare Advantage organizations and Medicare Part D sponsors are well- positioned to identify and address improper opioid utilization by working with prescribing physicians. Our job at CMS is to oversee these efforts and to make sure that plan sponsors have the tools and information they need to be as effective as possible. We do this in a number of ways. First, as my colleague from GAO knows, we use the Overutilization Monitoring System, or OMS, to help ensure plan sponsors have established systems and programs to help prevent overutilization of prescription opioids. Through this system, CMS identifies high-risk beneficiaries who have visited multiple pharmacies or prescribers. We then report these high-risk beneficiaries to plans who conduct case management or implement real time alerts at a pharmacy. This effort has been very successful, with a 61 percent decline in the number of beneficiaries meeting the OMS criteria from 2011 to 2016, even while Part D enrollment was increasing at the same time. To improve on these outcomes and to better identify high- risk beneficiaries, we have improved the criteria used in OMS to reflect the Centers for Disease Control's prescribing guidelines. This action will allow us to better identify potential opioid overutilizers and is just one of the many ways we are collaborating with our colleagues in HHS to tackle this epidemic and further protect beneficiaries at high risk of opioid overutilization. Thanks to recent action taken by Congress, CMS now has the authority to implement a new Medicare Part D lock-in policy. CMS has proposed to integrate this new authority with our OMS to expand upon our existing innovative approach to reduce opioid overutilization in the Part D program. We believe this approach will improve quality of care through enhanced coordination while maintaining access to necessary pain medications. Second, all plan sponsors are using real-time alerts, referred to as safety edits, to flag potentially unsafe opioid prescriptions at the pharmacy. When these alerts are triggered, the pharmacist must take an action, depending on the type of safety edit, before the prescription can be dispensed. Through this process, prescribers can receive important information about their patients, such as a better picture of a patient's total opioid dosage and prescription history. Ultimately, this helps prescribers make more informed decisions about the care that they are providing to their patients. Third, CMS tracks and monitors the number of Part D beneficiaries who receive high doses of opioid prescriptions regardless of the number of prescribers and pharmacies being used by the beneficiary. Using this information, CMS sends monthly patient safety reports to plan sponsors so they can conduct case management. Ensuring that Medicare beneficiaries with substance use disorder have access to the most effective treatment is a critical component of addressing the epidemic. We want to make sure that we cover the right treatment for the right beneficiaries in the right setting, and we are working to increase access to medication-assisted treatment by requiring that Part D formula include MAT drugs as well as Naloxone. In addition to these efforts to identify and protect beneficiaries who are at high risk for opioid overutilization, CMS also uses data to identify prescribers and pharmacies with questionable opioid prescribing and billing patterns. Plans receive quarterly reports on outlier prescribers and pharmacies they can use to initiate new investigations, conduct audits, and take administration actions like terminating a pharmacy from their network. Based on a recommendation by the GAO, these reports now separate outlier prescribers of opioids from other Schedule II prescribers. As we move forward with our efforts to curb this public health crisis, CMS plans to enact comprehensive strategies from all Medicare Part D sponsors on their activities aimed at combatting the opioid crisis. This will help CMS better understand the approaches sponsors are taking from both their Medicare and commercial alliance. Once we receive this information, we will conduct an analysis and provide best practice guidance to all plans. While CMS has taken numerous steps to improve our opioid overutilization and monitoring programs, we know there is much more we can do. We appreciate the work and recommendations from our colleagues at GAO and OIG, and we are continually assessing how we can best utilize our tools as a payer to build on their recommendations to tackle this crisis. Thank you for your interest in our efforts to protect Medicare beneficiaries, and I look forward to answering your questions. [The prepared statement of Ms. Brandt follows:] [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT] Chairman JENKINS. Thank you. And I appreciate all three of you being here today with your excellent testimony. We will now proceed to the question and answer session. And I would like to direct my questions to Ms. Curda. Ms. Curda, in your testimony, you discussed how the OMS tracks only a small portion of the potentially at-risk beneficiary population. Can you talk more about what GAO found? Ms. CURDA. Sure. We found that the criteria that CMS is currently using in its OMS tracked the very high dose-- beneficiaries who are getting very high doses, who are using multiple doctors, multiple pharmacies, but they aren't tracking the larger number of beneficiaries that are at risk of harm because they are receiving higher doses of opioids. These are those that are receiving more than 90 milligrams morphine equivalent dose per day, which is indicated in CDC guidelines. According to a one-time analysis that CMS performed, this criterion covered about 700,000 beneficiaries in 2015. So, just relatively speaking, we are talking about 700,000 beneficiaries taking very, very high levels of opioids, versus the OMS criteria, which is in the sort of more tens of thousands range. And so, we recommended that they gather that data, not just for reporting back to the plan sponsors, but because it has this goal of reducing harm from opioid use, to track and monitor that information over time to see what is happening with that number of beneficiaries, to see is it going up, is it going down, and use it to inform its strategy. Chairman JENKINS. Right. One of the recommendations that GAO made was for CMS to track beneficiaries receiving large amounts of opioids, irrespective of the number of pharmacies and providers that they used to obtain them. Can you talk about why you believe this to be important? Ms. CURDA. Sure. CMS does track very useful information on--using its overutilization system, and also in its in- patient quality measures. But neither of those measures track the larger number of beneficiaries that are receiving harmful doses of--potentially harmful doses of opioid medication. And so we think that, in routinely collecting this information, they can better inform their strategy and track their goal achievements. Chairman JENKINS. What specific data do you believe is important for CMS to track? Ms. CURDA. This would be the patients receiving either 90 milligram morphine equivalent dose per day or greater through Medicare. Chairman JENKINS. Okay. How much of that data is currently being utilized for CMS for these purposes, and why do you believe the current data CMS is monitoring to be insufficient? Ms. CURDA. It is basically just a measurement issue. The CMS tracks data, but not at that level. And they don't use it for the purposes of monitoring this harmful use of opioids over time. So we believe that by collecting this information and monitoring it, over time they can better track whether they are achieving their goals. Chairman JENKINS. Okay. Thank you. I would now like to recognize Ms. DelBene. Ms. DELBENE. Thank you, Madam Chair. The Administration recently released guidance indicating that it would allow States to implement work requirements to access Medicaid. Ms. Brandt, in your testimony to the Committee, you state one of the points of the comprehensive evidence-based opioid strategy is to ``improve access to treatment and recovery services, and to enable individuals to achieve long-term recovery.'' In the guidance that was put out, the Administration requires exemptions for individuals with medical conditions, such as substance use disorders, and outlined that medical treatment for any--for their substance use may fulfill a work requirement. My question is, how does a work requirement improve access to treatment? And, second, how can an individual who is suffering from addiction access treatment to fulfill their work requirement if they are not allowed to get Medicaid and can't have that to cover such a treatment? So, we end up in this circular situation where someone doesn't have coverage, so they can't get treatment, but they can't fulfill the work requirement because they need to be in treatment to do that. Can you explain how we would address that? Ms. BRANDT. Thank you for your question. While the work requirements and the Medicaid requirements are not my day-to- day responsibility, I will do my best to sort of answer, to the best of my knowledge. As part of our issuance last week, as you mentioned, States are required to take steps to ensure access to appropriate treatment or services. And one of the things that they are supposed to do is make reasonable modifications to ensure that people who are receiving treatment for substance abuse disorders or opioid treatments are able to have reasonable accommodations. And so we have worked to provide guidance to the States to help them to ensure that balance, and the goal is to ensure that the beneficiary who is receiving those treatments can hopefully be able to have the appropriate accommodations made so they can continue to receive it. Ms. DELBENE. So, if a State doesn't come up with a work-- with the work-around, as you describe, how would someone access Medicaid so they can get treatment if they can't fulfill their work requirement because they can't fulfill--they aren't allowed to access treatment? Ms. BRANDT. Well, our goal is to work with the States to ensure that they would be able to provide those types of accommodations as part of what they are supposed to do under the mandate of the work requirement. And we would work with them to ensure that the beneficiary, hopefully, would be able to continue to receive those types of services. Ms. DELBENE. Thank you. As CMS moves more providers to value-based payments in an effort to improve quality and lower healthcare costs, part of the challenge is to properly risk adjust for high-needs patients. And because substance use disorder is such a complicated condition that demands a tremendous amount of coordination of care, this may be one of the conditions that warrants a risk adjustment. And, in fact, this was done for a managed care demonstration in Massachusetts that focused on dual eligible enrollees under 65. Ms. Brandt, have you considered how we can better align payment to promote coordination and quality care for people with substance use disorders in other value-based and managed care arrangements like ACOs and Medicare or Medicare Advantage Plans, and how is CMS promoting coordination of care between providers to mitigate the instances of high amounts of opioid prescribing? Ms. BRANDT. Thank you for your question. As I mentioned in my oral and written testimony, ensuring good access to beneficiaries across our payment lines is one of the goals at CMS. And one of the things that we have been doing is looking across all of our payment types, especially as we begin the new payment rules for this year and as we have discussions with providers to determine where we can do more and how we can have better coordination with them on just these types of issues. So it is something that we are currently engaged in as an agency, to try to figure out better ways to make sure that we are striking that balance and making sure, as I said in my testimony, that we have the right treatment, for the right people, in the right setting, at the right time. Ms. DELBENE. I understand that the--things like the managed care demonstration in Massachusetts have been looking at these scenarios. Is there something that you have learned from these that will better inform us on how best to address more complicated situations like substance use disorders? Ms. BRANDT. I can't speak specifically to the Massachusetts demonstration project because I am not familiar with the outcomes of that, but I can tell you that we have been looking at all of our demonstration projects, the models we run, and our Centers for Medicare and Medicaid innovation, as well as across the CMS programs to look at lessons learned and best practices, and we are trying to bring all that to bear as we try to figure out good solutions for this crisis. Ms. DELBENE. Thank you very much. I yield back. Chairman JENKINS. Mrs. Walorski is now recognized for 5 minutes. Mrs. WALORSKI. Thank you, Madam Chair. Thank you to our witnesses for being here today. Like so many of the parts of the country, the opioid epidemic has affected my district in Indiana. It has destroyed lives, torn apart families, and put stress on first responders, hospitals, the foster care system, and other vital community institutions. Unfortunately, last year a dear friend of mine, a doctor in my district, was murdered for refusing to prescribe opioids. Opioids come in many forms: pills, heroin, the emerging threat of fentanyl, and others. Unfortunately, this means that there are too many fronts in the fight. Mr. Cantrell, I just want to ask you, identifying overprescribing by providers is incredibly important; however, examining at-risk beneficiaries can also help identify providers who are potentially overprescribing. The Inspector General identified in my State, Indiana, a prescriber who wrote an average of 24 opioid prescriptions each for 108 beneficiaries who received extreme amounts. Can you talk about your approach to identifying potentially problematic prescribers, and then also, once these prescribers are identified, what happens? Mr. CANTRELL. Yes, thank you. First of all, in our data brief, we used an analysis approach that we hadn't previously utilized. We wanted to first focus on the beneficiaries who are at greatest risk of harm because of the volume of opioids they were receiving. And, instead of just looking at the universe of claims, we look then at the individuals, the prescribers who were prescribing specifically to a high number of those at-risk beneficiaries. So, that led us to, in our report, 400 different prescribers who were prescribing either to a large number of doctor-shopping Medicare beneficiaries, or to a large number of patients receiving high amounts of opioids. So, when we have this analysis, we use this data--first, we report on these results, so that we can inform the public. We share this information with CMS, so they can begin engaging in administrative or other review to monitor these prescribers, and we refer many of these out to our field offices, to our partners at the Department of Justice for criminal investigation. Now, with 400 different prescribers identified, it isn't necessarily the case that all are committing fraud, so we sift through the data to identify those that appear most likely to be committing fraud, send them out to the field, and then, ultimately, it takes boots on the ground to investigate these matters and bring individuals to justice who have committed this fraud. And so it is very intensive work, and we work closely with DEA, FBI, State agencies, and local law enforcement, and this is a huge priority for us to bring individuals who are prescribing in the Medicare and Medicaid space these opioids illegally. Mrs. WALORSKI. And just as a followup, I have heard from doctors in my district. They would like to have access to more data so they know, and they are a little bit less at risk on, you know, falling into some kind of a doctor-shopping kind of a network. Can you talk about ways you believe we can improve data sharing to combat opioid abuse? And then, are there ways to improve data sharing really just while working within State privacy laws as well? Mr. CANTRELL. Well, first of all, we certainly encourage the utilization of prescription drug monitoring programs in every State. We believe these are an important tool. For us, we see Medicare claims data, we have great visibility there. We have a little less, slightly less, but some visibility in the Medicaid, but we don't see cash-based transactions and other transactions like that, which the PDMPs would include. And so, we think it is vitally important for prescribers and pharmacies to check these PDMPs to make sure that they are not dispensing to doctor-shopping patients. And we look for other ways to share this information across both the Federal Government and with the States and the private sector. One of the things I think is most important that we have done is share their approach to this analysis, but also the underlying data with our private sector program integrity partners who we work with, through the Healthcare Fraud Prevention Partnership and the National Healthcare Antifraud Association. So they are empowered to conduct their own analysis, monitor these individuals, and hopefully have a broader impact. Mrs. WALORSKI. I appreciate it. And, Ms. Brandt, just quickly, is--one of the things I have continued to work on here is access to non-opioid alternatives. Is CMS developing a plan to use more non-opioid alternatives for patients with chronic pain? Ms. BRANDT. Yes. As I mentioned in my oral testimony, we are working to increase access to medication-assisted treatments and are looking and working with the CDC and other partners to determine---- Mrs. WALORSKI. On a scale of one to ten, where are we, in looking? What have we found? What are we doing? Ms. BRANDT. We have done a number of stakeholder listening sessions over the past while, where we got a lot of valuable input, and we have been having meetings with NIH, CDC, and others. So I would say we are probably at about a six; we have more to do, but we are definitely moving in the right direction. Mrs. WALORSKI. Thank you. Madam Chairman, I yield back. Chairman JENKINS. Mr. Neal is recognized for 5 minutes. Mr. NEAL. Thank you, Madam Chairperson. Massachusetts, as I noted in my opening statement, is really--we are reeling from the addiction crisis, and your testimony was really well done this morning, the three of you. The number of opioid-related deaths in Massachusetts is now four times higher than it was 15 years ago, and it continues to get worse. We certainly owe it to our communities and to our families who have been hit by the epidemic to prevent addiction; that means earlier intervention and treating those afterward as well. There is a compelling argument as to the most effective way to treat opiate addiction for all of us. Medication-assisted treatment, MAT, is the evidence-based standard for treating opioid addiction. Medical and substance use disorder experts in the President's own Commission point to MAT as a vital tool to attack the epidemic. Medicare is usually the standard bearer when it comes to healthcare coverage, but Medicare does not cover a key MAT option, methadone for outpatient service. Ms. Brandt, Ms. Curda, you both testified about the importance of MAT in your opening statements. What is the Administration doing, and what would you recommend that it continue to do or should do to expand access to medication-assisted treatment? Ms. BRANDT. Well, as I mentioned, Congressman, we are continuing to look at the wide range of alternate treatments, such as Naloxone and others. We are well aware of methadone and the statutory impediments to that, but we are open to working-- I know you have legislation on that--we are open to working with Congress to provide technical assistance on those issues. But we can continue committed at CMS to determine what all we can do to increase the access to medication-assisted treatments. Ms. CURDA. We prepared a couple of reports on the issues surrounding access to medication-assisted treatment, not specifically in Medicare, but in general. The first report we did looked at the sort of regulatory and legal framework for access to these drugs, and also looked at some of the barriers to access. And there were things like not having enough doctors who have the appropriate waivers in order to prescribe this medication, and also in some cases, simply attitudinal issues where this is viewed as perhaps a substitute for another kind of addiction. So taking these issues into account, Congress passed legislation last year to enhance access to medication-assisted treatment, and we did a further report looking at HHS's roll- out of the grant programs intended to enhance access to medication-assisted treatment, and we found that they had a strategy for accomplishing this. They were getting the programs going. It was a little too early to assess their effectiveness, but we did note that they did not have any sort of measures in place for their goals for expanding access to MATs, so not knowing sort of what the ultimate goal is for that, and that they did not have sort of firm timeframes. They had planned an evaluation of their efforts, but they did not have any firm timeframes for when that would be done. Mr. NEAL. Thank you. I hope the Administration and my colleagues on the other side, who I know are all sincere in their efforts on this, would also be supportive of another piece of legislation that I have offered, and that would be to hold harmless first responders who administer Naloxone. When they show up, oftentimes there is violent reaction as the high comes down, and they sometimes have to subdue the individual who has just been treated; save their lives, and then are attacked for saving their lives. So I think holding those individuals harmless would make a good deal of sense, and I hope that the--in a bipartisan manner we might be able to address that part of this complicated issue as well. Thank you for your testimony, and thank you Madam Chairperson; I yield back. Chairman JENKINS. Mr. Schweikert is recognized for 5 minutes. Mr. SCHWEIKERT. Thank you, Madam Chairman. My assumption is that everyone in this room has been affected by addiction in a family member, a friend, or a neighbor. Growing up in a household where my mother was actually an addiction counselor, after years of fighting through her own demons, you actually just understand how complicated this is. This is actually an interesting opportunity, as the Ranking Member was talking about some of the different pieces of legislation he has, and I agree, we should actually start to step up and do a package, because there is no golden bullet here, no magic bullet. But I do want to also touch on--we have a piece of legislation, and it is bipartisan, we have Republicans, Democrats, and this Committee from E&C, and that is a mechanism to standardize the prior authorization process, so the electronic mechanism is underneath. And Ms. Brandt, I am going to ask you to sort of walk us through right now for Part D, how prior authorization actually is working today, and then I want to sort of pitch everyone on the Committee, the concept of, let's actually put together a package of bills, hopefully our prior authorization standardization will be one of those. But how does it work today for Part D? Ms. BRANDT. Well, let me caveat by saying, I am not a Part D expert, so I will give you the best of my understanding---- Mr. SCHWEIKERT. Okay. Ms. BRANDT [continuing]. As to how it works. But currently the way it works is that the Part D sponsors have formularies which have approved drugs on them, and as patients present, they see if the drugs that they are looking to receive, that are being prescribed to them, are off of that formulary. And then they determine whether or not, based on CDC prescribing guidelines, they meet the appropriate dosage amounts. Some of what the GAO was saying, we have been working to incorporate into our Overutilization Monitoring System to determine that beneficiaries are not prescribed beyond what are acceptable levels in the program. And so, using those types of criteria and screening, it is then determined what is appropriate to be able to authorize to be paid under the person's plan. Mr. SCHWEIKERT. For our other witnesses--and thank you for that. Any other thoughts, that if I came to you--in reading the testimony, it looks like we are doing a much better job in our data collection and data modeling and finding bad actors. Okay, now that we have the data, how do you move to a solution? Is it alternative pharmaceuticals? Is it a standardization of the red flashing light for the pharmacy or the doctor, saying, this doesn't need to be filled? You have the data; what is the next solution, what is the next layer? Mr. CANTRELL. One of the things that we are recommending and continue to monitor is the beneficiary lock-in program that has now been authorized and CMS is working to implement. With the number of beneficiaries at risk because of the volumes of prescriptions they are receiving, I think this data analysis leads us to patients that maybe should be considered for this type of lock-in, at least gets us started as to where to focus these efforts, and that will help manage the care of these individuals who need services. Mr. SCHWEIKERT. All right. Ms. CURDA. We didn't acknowledge that issue specifically, but I think you can sort of take an all of the above approach, you can--all of these things working together can help. One thing we looked at, a couple of years ago, was more of a prevention focus. It gets very costly when it gets to the point where someone is addicted to opioids and requires therapy and treatment. It is much better to prevent the addiction in the first place; to the extent that we can have controls in place to flag these individuals who are getting very high doses, it is very helpful. But we did a--the Comptroller General held a forum that talked about prevention and talked about educational healthcare and sort of a legal kind of strategy. Mr. SCHWEIKERT. That is actually a very rational approach. In my last couple of moments, I will pitch our new Chairman, which I am elated to have you--I feel so tall next to you. There is an opportunity here for us to take a number of the pieces of legislation, because we know there are some alternative pharmaceuticals out there that actually have less addictive effects or more stabilizing effects. There is my fixation on taking the data that has been collected, building that standardization on the preauthorization so we stop--it becomes almost a preventative because you don't write the prescription. And the uniqueness of this Oversight Committee, and its charter, we have the ability to do legislation. Maybe it is time we all get together, figure out if we have solutions, bundle them together, and move forward. And with that, I yield back. Chairman JENKINS. Excellent. I yield to Ms. Chu for 5 minutes. Ms. CHU. Thank you. Mr. Cantrell, in your testimony you mentioned an example of drug testing or treatment fraud in which sober living homeowners were bribed to direct their residents to a specific lab for their year-end sample screenings. As you noted, this resulted in fraudulent earnings at the expense of sober living homeowners and those residents who are in recovery. I truly appreciate the OIG's attention to this issue, as I have heard directly from constituents about the fraud and abuse that can occur in sober living facilities. And, in fact, the bottom line is we need better oversight, because not only are these bad actors preying on vulnerable individuals who have just left treatment, but institutions like the OIG are playing catch-up to find these nefarious actors, and in the meantime, more individuals can be hurt. So I believe we should be assisting those who have entered and completed treatment and who need support to make a full recovery. That is why I introduced the bipartisan H.R. 4684, the Ensuring Access to Quality Sober Living Act, and it would direct a Substance Abuse and Mental Health Services Administration, or SAMHSA, to develop a set of best practices for sober living facilities so that individuals and families with loved ones just leaving treatment can better identify the good actors from the bad. So, Mr. Cantrell, can you expand upon the OIG's efforts to address fraud and abuse in the sober home industry? Mr. CANTRELL. Yes. Thank you. Sober homes have become--we used to talk a lot about pill mills, now we have sober homes becoming fraud mills. These aren't services that are necessarily covered by Medicare or Medicaid, but they are ways to attract people at great risk because they are likely addicted--have a substance abuse disorder, need treatment, need services, but instead corrupt sober home owners are basically farming them out for either medically unnecessary services, treatment, or testing, or services and treatment that are just never provided. Sometimes these homes are places where individuals can continue to get drugs. And so we have all read about the horror stories of individuals going to these homes trying to get treatment and ultimately overdosing. So this is a problem that is of great concern to us. Largely, it affects us on the ancillary services side as they farm them out, pay kickbacks to doctors and drug testing labs. But it is also through the Healthcare Fraud Provisions Partnership, we know it has had an enormous impact on the private sector payers as well. So this is definitely a problem that we are noticing and we are tackling as it affects Medicare and Medicaid. Ms. CHU. Well, I thank you for pursuing it. And now I would like to address a question to Ms. Curda. We know that there is, of course, obviously, an unprecedented crisis, and we are going to have to find solutions that work for everyone, and that is why I believe we should be expanding our treatment options for a vulnerable population to include alternative medicines like acupuncture. Acupuncture has been the subject of numerous studies by the National Center for Complementary and Integrated Health and the National Institutes of Health, and it has been found to be nonadditive, noninvasive, and can be good for conditions like migraines, hypertension, chronic pain, or arthritis. And, in fact, no less than 13 independent studies on the effectiveness of acupuncture are referenced in NCCIH's web page on acupuncture. At a time when there is an over prescription of opioids, I believe that we should be opening our doors to alternative treatments like acupuncture. And that is why I introduced H.R. 2839, the Acupuncture for Heroes and Seniors Act, which would ensure that qualified acupuncturist services are covered through Medicare. It is currently available for individuals who receive their health insurance through the Affordable Care Act in States like California, as well as in some Medicaid plans, but seniors should not lose out. So, Ms. Curda, has the GAO ever studied the impact of making acupuncture available through traditional Medicare plans? Ms. CURDA. No, I don't believe that GAO has done that work. Ms. CHU. Is it possible for GAO to evaluate the effectiveness of offering integrative health alternatives like acupuncture to opioid prescribing practices and government healthcare programs? Do you foresee any hurdles in such an examination? Ms. CURDA. Yes. I think GAO could look at that question. The hurdle would be the sort of status of the literature and evidence in that area. We would probably want to first do a review of the literature to see, you know, what does the peer- reviewed literature say about the effectiveness of that treatment. And we could certainly describe, you know, what that evidence lays out. Ms. CHU. Thank you. Chairman JENKINS. Mr. LaHood is now recognized for 5 minutes. Mr. LAHOOD. Thank you, Chairman Jenkins. And it is an honor to be part of this Subcommittee and Full Committee, and I appreciate the opportunity to have this subject matter before us today. And I want to thank the witnesses for your valuable testimony here today. I represent a district in central and west central Illinois that is a rural district, 19 counties. And this is an epidemic that continues to rage in a district like mine. And it really transcends socioeconomic--all socioeconomic categories, rural, urban, and all sectors of society. And over the last 2 years, I have held a number of roundtables in my district with first responders, law enforcement, judges, treatment center providers, and physicians, to try to understand the issue better, but also look at how we, from a public policy standpoint, what we can do to fix this problem. And as I look at the numbers in Illinois, data from 2016 shows that, in a 3-year period, deaths from overdose increased by 44 percent from 2013 to 2016, and over 80 percent of those deaths were attributed to opioids. Of those 80 percent of opioid-attributed deaths, there was a 70 percent increase from those attributed from opioids in that same 3-year period. In Adams County, in my district, they have seen a 360 percent increase in emergency department visits related to opioid and heroin overdoses over that 5-year period from 2010 to 2015. Additionally, the county saw a 300 percent increase in overdose mortality rates due to opioids and heroin in the same period. And looking at what is the solution, obviously, we have looked at--from a law enforcement perspective, what do we need to do on the criminal justice side? Also looking at how you hold doctors accountable, and what we do in that space. We have talked a lot about, you know, how we have more resources and money for treatment centers. And in some ways, when we look at this epidemic and the direction we are going, I equate it in some ways to what drunk driving was in this country 25 years ago. It was raging out of control, so what did we do? We allocated resources, we raised awareness, we had a public campaign, and we also had something called Mothers Against Drunk Driving that was organic that started. So I don't necessarily think this is a Federal solution, this is going to be solved in Washington, DC, and that we have to work with our local stakeholders in our different States and local areas that are doing a lot of good work on this. And so when I think about the testimony here today, Mr. Cantrell, I wanted to ask you, you talked a little bit about prescription drug monitoring systems. In terms of States that have done a pretty good job on that, can you talk about examples of that, which have kind of been a model for how to do it, and what they have done to be successful? Mr. CANTRELL. The OIG hasn't completed any work on evaluating PDMPs across the country. But in just talking to our staff across the country, our special agents, and hearing from individuals who work in different States, there are a couple of things that need to happen, I think, to make a PDMP successful. One, it has to be--there needs to be some sort of requirement that data be entered in a timely fashion. I think that, for those that are successful, there is timely data entry, there is timely review of that data. Sometimes there needs to be interoperability. Some of these PDMP systems don't talk from State to State, and we see many fraud schemes, of course, that cross State lines. So the States that have interoperability with their neighboring States, that is a plus. And then we have seen, in terms of data access, for us in law enforcement, some States restrict access for law enforcement, and other States allow that sort of access. From my perspective, of course, I believe in that law enforcement access to help identify those individuals who may be prescribing or doctor shopping in seeking to divert drugs. So those are some of the components of what I think can make up a successful PDMP. Mr. LAHOOD. And is there an example or a model you can point to that has done a pretty good job around the country? Mr. CANTRELL. I just heard anecdotally that, as Kentucky got started, they were doing a pretty good job; they are one of the earlier ones that I was hearing about. I have heard that the State of New York, from our agents, is doing a pretty good job, but I don't have any data or any statistics to point to their success or favor. That is just anecdotally what I have heard from some of our agents. Mr. LAHOOD. Thank you. Chairman JENKINS. Mr. Crowley is recognized for 5 minutes. Mr. CROWLEY. I thank the Chair, I thank the Ranking Member for holding this hearing today on what has become a devastating epidemic for our Nation. My district, like many other districts across the country, has been ravaged by the opioid epidemic. More Bronx residents die of drug overdoses--more Bronx residents died of drug overdoses in 2016 than any other New York City borough. Out of the 308 overdose-related deaths, 85 percent involved opioids generally, and 76 percent involved heroin or fentanyl. This devastation is unaccepted anywhere. But there is an aspect in my district that is notable, part of the opioid epidemic when compounded with other parts of the country. The increase in prescription opioids across the country has led to a spike in heroin use, which people turn to for a more potent high as they run out of their prescription medications. Heroin has become even more accessible and cheaply available to communities across the country. In a community like mine, which is still recovering from the aftermath of the failed tough on crime tactics of the 1980s and 1990s, residents have not properly dealt with their addictions and are more likely to use and abuse newly available heroin. That makes opioid-related overdoses a side effect of the race-based drug enforcement policies of the past. As we work to address the opioid epidemic, I encourage this Administration and my colleagues in Congress to work toward a more holistic approach that focuses on treatment rather than punishment. And I challenge all of us to strive for a better understanding of the entirety of the epidemic, which impacts different communities on different levels. Urban communities, particularly communities of color, must be a part of this conversation, and they must be a part of the solution to this terrible and growing problem. Mr. Cantrell, in the OIG report, Opioids and Medicare Part D, there are concerns about extreme use and questionable prescribing, and it suggests that prescribers are not checking the State prescription drug monitoring databases, or these databases do not have current data. Can you explain how prescribers are trained or are supposed to be trained on how to use their State prescription drug monitoring database? Mr. CANTRELL. I am sorry, but I don't actually know the training requirements for the use of these prescription drug monitoring programs. And I would suspect it might vary from State to State. Mr. CROWLEY. Do you have State-based data on where there are vulnerabilities of prescriber use of prescription drug monitoring databases? Mr. CANTRELL. We do not at this time. Mr. CROWLEY. Thank you. What are HHS-OIG's recommendations for improving prescriber use of these databases? Mr. CANTRELL. Education is certainly one strong component. And we, along with the DEA, who goes around the country talking to pharmacists and prescribers, participated in these events to train and educate individuals in the community about the importance of this tool and the fraud schemes that they should be looking out for when utilizing these tools. So I think education is critical. And I, once again, this is not based on any analysis that we have done, but I have just heard there are some barriers to utilization because it can take a long time to access these PDMPs as they are providing patient care. I have heard from individuals in the community that sometimes just the nature of the system can, maybe it is slow, and it can deter you. So I think that obviously any improvements that can be made to increase the timeliness of these sorts of data checks would be critical to ensuring adoption and use. Mr. CROWLEY. I think there is one critical area in terms of government that can be involved in helping to get a handle on what is happening in each of the States. And I would hope that we would have a more robust addressing of the monitoring databases. Mr. Cantrell and Ms. Curda, does the OIG or GAO look at race as a factor in collecting data regarding the opioid epidemic? Mr. CANTRELL. We do not. Ms. CURDA. We have not looked at that. Mr. CROWLEY. Well, thank you. And I appreciate your time here today. Thank you very much. I yield back. Chairman JENKINS. Mr. Bishop, you are recognized for 5 minutes. Mr. BISHOP. Thank you, Madam Chairman. Thank you to the panel for being here today and providing your valuable testimony. I appreciate the information that you shared and your expertise. I am from the State of Michigan. I share all the same concerns that the rest of the Committee has on this subject. Each of us has our own stories to tell. Over and beyond the direct impact on families and individuals who are impacted by this scourge of opioid abuse, there is another statistic that I find alarming. The American Enterprise Institute recently published a study looking at the cost of the opioid epidemic. And it did it by State. And I was astounded to see that in Michigan, where I am from, my home State, the cost of opioid addiction is over 4 percent of our State's GDP. And yet I look at other States on this table that we have been provided, and it shows other States that have also been impacted, but not to the extent that other States have. There is a huge disparity in how much other States have been impacted. For example, the White House Council of Economic Advisors, it estimates the societal burden to fight the fatalities from opioid overdoses, and also estimated the nonfatal cost of the opioid epidemic in 2015 to be $72.3 billion, and the fatal cost to be $431.7 billion. And then you look at the State by State, and you see the huge disparity. And I am wondering, why does it cost West Virginia, which has the highest per capita burden at $4,793 per resident? And then you look at Nebraska, which is $465 dollars per resident. Why is that? Are there more resources there? Is there some kind of demographic there that is more susceptible to this? What causes this kind of data? Can someone tell me that? Mr. Cantrell. Mr. CANTRELL. Just in terms of what we see, what we focus on, fraud trends, you know, there is a variety of factors, but we definitely see that once a fraud scheme takes root, it becomes viral in communities. And that is no different, I think, than in the opioid epidemic. And our agents, unfortunately, in the Detroit area, see numerous fraud investigations related to illegal opioid distribution. And sometimes we are told that it is an export area. So that those drug schemes are meant to often export those drugs to other States where they can get higher reimbursement. So this is the intelligence, you know, we hear from the ground. Once again, I don't have any analytics available to point to reasons why one State is different than the other, but, you know, we have continued throughout my career, my 20- year career, certainly to see South Florida as a hotspot or an epicenter of healthcare fraud in general. It has also been a point where we have seen lots of fraud related to opioids. Certain communities where this has taken root, it is hard to get rid of it once it has taken root. Mr. BISHOP. But you can identify those areas, those demographics where this kind of abuse and fraud happens. You have indicated that you have an opioid abuse and fraud program that you administer. Can you tell us how that works and what the resources are? Who is in charge of it? What is your mission in that organization? Mr. CANTRELL. So, that is a new unit, established by the Attorney General just last year. As it was initiated, they rolled out 12 prosecutors in 12 districts around the country to focus specifically on this epidemic. And as a partnership, FBI, OIG, DEA, we all dedicated agent resources to those prosecutors. Now, that is just a small, at this point in time, kind of effort in comparison to the total effort nationwide in this area, but it is an important focus in areas that were not necessarily the bigger markets that had the greater resources. We focused on smaller markets in these first 12 districts to bring resources to various communities that hadn't necessarily seen the amount of resources in the past. Mr. BISHOP. Thank you for that. You also mentioned there were private sector partners as well. I am interested to know what the private sector is doing to partner with you. Mr. CANTRELL. So we talked, and CMS is an integral part of the healthcare fraud prevention partnership, but it provides a community of private sector payers, State agencies, as well as Federal payers and law enforcement to share, first of all, information about trends and schemes, but, also, it is a forum where they can safely share data from different resources, analyze that data, and come up with answers or identify issues across multiple data sources that were previously available to be searched across. So I think, for me, it is certainly of great value in learning about these schemes, because some of these schemes, like the sober home scheme that was discussed earlier, I was hearing about it from our private sector partners before we were seeing it impacting Medicaid or Medicare. And so it is a great intelligence tool. Mr. BISHOP. Okay. Thank you so much. And I yield back. Chairman JENKINS. Mr. Meehan is recognized for 5 minutes. Mr. MEEHAN. Thank you, Madam Chairman. I am grateful for you allowing us to sit in on this very, very important issue. And I want to thank you for the work that you are doing, each of the panelists, engaged in what is a remarkable challenge for all of us, and particularly back in our communities. I want to ask specific questions about the Medicare relationship to this, but in my own region of southeastern Pennsylvania, we have seen a staggering 83 percent increase in drug deaths. That is overwhelming. And when you look at what is driving that, the distinguishing issue appears to be fentanyl, but it is fentanyl which is tied to its use with, oftentimes, opioids. And I know we are dealing with a poly-drug environment, and there is no simple solution. But if we are going to have an impact on this, we want to start by dealing with the opioid abuse in the first place. We have worked on some programs here in Congress with things that we have done already that have come from recommendations from people like you. One of those is the Medicare lock-in. And I have listened to each of the panelists describe in various ways how individuals have been able to utilize the system, either by going to multiple pharmacists, or multiple doctors, or multiple plans to get the drugs. And still staggering, that even with Medicare, we are talking about people who are later in life-- often, not all the time--but later in life, and we are still talking about dependency in that group. So the lock-in program, as I understand right now, Mr. Cantrell, would allow us to have a designated distributor and a much better control over that individual's relationship. Now, there have been recommendations and utilization by numbers of plans, but CMS itself, or at least the government, hasn't created it. Can you tell me where we are on that, where you think lock-in may be utilized? Mr. CANTRELL. Well, first, I will say we are very supportive of lock-in, but I think I would like to defer to my colleague from CMS to talk about where it stands. Mr. MEEHAN. Is this Ms. Brandt? Ms. BRANDT. Yes. Mr. MEEHAN. Because I was going to go to you next because you---- Ms. BRANDT. No problem. Mr. MEEHAN [continuing]. Mentioned that in your testimony. Ms. BRANDT. I am happy to. As I mentioned in my testimony, we really appreciate this, this additional tool from Congress. We agree with the OIG. We think this is going to be a very powerful tool. We are currently in the notice and comment period for this. We have to promulgate regulations to implement it. In fact, the comment period closed yesterday, so that's good timing with the hearing today. But we are looking forward to reviewing those comments and then implementing those comments as we do the final rule. And then, beginning in 2019, we will be able to begin using this tool. And we are very excited at the potential that it is going to add to our suite of tools to help us address these types of issues. Mr. MEEHAN. How do you think it is going to make a difference? Ms. BRANDT. Well, it will make a difference because it will allow us, as you said, to limit. We will be able to limit a beneficiary to a pharmacy and be able to have them at one pharmacy. And that is the only place, or however it works out for implementation--we are still working all that out--but essentially, they could be limited to one pharmacy, which would allow us then to be able to see their billings just related to that pharmacy. Right now, they can go to multiple pharmacies, multiple prescribers. This limits the scope of that much more narrowly. Mr. MEEHAN. Okay. If you know, because I am sure the comments have come from a variety of places, but I am assuming you have been monitoring this as we have been going through the comments. Have there been any observations which have influenced your thinking on this or any kind of a perspective that was shared in the comment period that either opens up a new place for us to consider the program or a concern that we may not have been thinking about? Ms. BRANDT. Well, as the comment period did just close yesterday and because it is open rulemaking, I am afraid I can't speak to that, sir. Mr. MEEHAN. Okay. Ms. BRANDT. But as we move forward and have things that we can share, we will be happy to do so. Mr. MEEHAN. Okay. Well, I appreciate that. May I just ask if anybody has a thought on one other problem that I am hearing quite a bit about, and it does relate to opioid abuse, but it is the abuse of treatment programs in certain States in particular, in which people appear to get treatment for a period of time, they go off, and there are almost finder's fees to get them in, and they walk out. And people are targeting them to get them readdicted, getting them back into treatment so long as there is a payer, they are in, then they pull them out. And some of these things appear almost to be scams. Is anybody looking at this issue, or does anybody have any thoughts? The OIG. Mr. CANTRELL. Unfortunately, we are seeing a great deal of fraud relating to the treatment side of this epidemic, where we need legitimate services the most. We discussed the sober homes where addicted residents are sometimes farmed out for lab testing that is either never provided or isn't appropriate, and they are billing thousands of dollars for these residents, for these tests. They are offered counseling, which once again is never provided or isn't the quality of counseling that actually these individuals need. And unfortunately, we are also seeing, in terms of some of the medication-assisted treatment, which, I think, many have discussed the importance of increasing access to that, we are seeing fraud schemes relating to this, the availability of these drugs that are intended to treat this crisis. So the fraud has followed this epidemic from source all the way to treatment. And that is the unfortunate thing that we are seeing around the country right now. Mr. MEEHAN. I would love to follow up more with you on that, but, Madam Chairman, I yield back. Chairman JENKINS. Mr. Blumenauer is recognized. Mr. BLUMENAUER. Thank you very much, Madam Chair. And I do appreciate our Subcommittee having this hearing. I think this is the first time Ways and Means has really dealt with this opioid crisis and the impact it has on the things that we are responsible for. I hope it is not the last. I hope that there is an opportunity--I think this is one thing that touches us all that we feel strongly about. It certainly impacts our community. It makes a difference in terms of employment. What is it, for one- quarter of the women who are ineligible of being in the workforce, there is an opioid problem, I am told. I am concerned that, as we are looking at different therapies, different options, there is a way to focus on something that some of our States have done, the State of Washington, the State of Oregon, dealing with medical marijuana. And I have some material, Madam Chair, that I would like to place in the record that makes it clear that States that have worked with medical marijuana prescribe fewer pills. [The submission for the Record of Hon. Earl Blumenauer follows:] [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT] Mr. BLUMENAUER. There is, on average, a 25 percent lower rate in terms of overdose deaths. The State that has had it the longest, medical marijuana, California, it is a third less. It is a cheaper alternative. It is not addictive, the way that we see with many of the opioids that have been handed out like Tic Tacs. It is an area where the public has demanded change. Politicians haven't brought medical marijuana to 29 States. It has been the public that has voted for--at least--excuse me, I guess Vermont is in the process of being the first State that does it legislatively. But this has been driven by individual voters. It is supported by strong majorities of the American public. Florida approved, in 2016, a medical marijuana program with 71 percent of the population. I would hope, Madam Chair, that we would have an opportunity to explore what the impacts are in terms of how Cannabis can prevent dose escalation and the development of opioid tolerance, which happens with people who are taking oxycodone or something like that. We have the opportunity to be a viable first-line analgesic. We have an opportunity to make a big difference with our veteran populations, who, sadly, we have policies in the Federal Government now that prevent VA doctors from even talking to veterans about the implications of medical Cannabis, even in States where it is legal. And I think we are missing a huge opportunity to help a troubled population, to cut down on the overdose deaths and save substantial amounts of money and, while we are at it, squeeze the black market, which is fueling a lot of other illegal activities. I hope, Madam Chair, that my colleagues will have a chance to look at the materials. It just happens to be from a physician, a researcher from Oregon. I hope you won't hold that against it, but the whole second page is documented in terms of justifying the points that I am making. This is something that we are no longer going to be able to avoid. The public is demanding it; 95 percent of the population has access to some form of legal marijuana. We have the so- called Charlotte's Web Law, where it is a low CBD dose that is available for children with severe seizure disorders. But when you put all that together, it is 95 percent of the population. The American Legion has come forward saying let's research this, let's look at it. We are hearing from veterans that it makes a difference. Last month I was at our VA hospital, and we were dealing with this precise subject of opioid addiction. And I happened to raise, in the course of the meeting, I said we ought to be looking at medical marijuana and the impact it has. When I walked out of the room, I was followed by a veteran who was on the staff, who took my hands and said, ``I am glad you raised that. I couldn't survive without medical marijuana.'' I think we are missing the boat if we don't dive into this. And I would commend this to my colleagues for their attention. Thank you very much. Chairman JENKINS. Mr. Reed is recognized for 5 minutes. Mr. REED. Thank you, Madam Chair. And as I was listening to some of the exchanges, I wanted to take a moment before I got into my prepared questions. My colleague from Washington asked about the work requirements for Medicaid, potential issues, and somehow that impacts substance abuse providers. And one of the things that it reminded me of is often Medicaid, and I know it is not the jurisdiction of this Committee, but Medicaid's--I seem to get the impression--goal of providing insurance coverage is the only metric that a lot of folks here in DC gauge its success by. By that I mean getting people into Medicare programs, therefore, they have health insurance and, therefore, our job is done. But I think we can do better than that. And, Ms. Brandt, I think your response to that question illustrated CMS' point of view that we can go beyond just insurance coverage and actually get to making people healthier. And so one of the questions I have for you when I want to understand the work requirements that are being proposed is: if someone is in treatment for drug addiction, I look at drug addiction as a disease. It is a medical-related situation. That individual, to me, is not an able-bodied individual as those work requirements I have advocated for over the years would envision. If someone is seriously addicted and in in-patient-type treatment, is it CMS' position that that individual is able bodied as we are trying to define it under the proposed work requirements that are being discussed across the country today? Ms. BRANDT. Thank you for your question. I am not sure I can specifically answer our definition of able bodied because, again, the work requirements are outside of the realm of what I deal with day-to-day, but I can tell you, as I mentioned before, that our goal is to make sure that States have steps that they are taking to ensure access to appropriate treatment services, particularly for those who have substance use disorders or opioid disorders. So if there are people with addiction issues, our goal is to work with the States to ensure that they are providing access to those services and that they are giving appropriate-- -- Mr. REED. If that addiction is a disease and that prevents them from being able bodied, I would hope that our official policy position would be that that is not who we are addressing with our work requirement. The other issue that I would raise on this that I am so passionate about, is one of the things that I hear from our employers across the country. One of the barriers to reemployment--which is empowering to individuals, employment, a job, an opportunity, does a lot for, not just earning their paychecks, but for their soul and their dignity and mental health and their physical health--is being addicted to drugs; not being able to pass a drug test. So we have a program under Medicaid or Medicare that is trying to address opioid addiction; does that not help us to try to solve the overall issue, when it comes to the example for Medicaid, in regards to getting people empowered to be put back into the workforce by getting their addiction under control and having the goal of, not just insurance coverage for those individuals, but also the services and the treatments necessary to get them into a healthy position, which removes that barrier to reemployment that I am discussing here today. Would you agree with that? Ms. BRANDT. Well, as I mentioned, our number one goal is the beneficiary. Our goal is to make sure we are getting the right treatment for the right people at the right time, to help get them to be as able bodied and productive as possible. Mr. REED. I appreciate that. And I share that commitment. And I hope our policies here at the Federal level achieve that, as we set them into a potential future course. Now to my more prepared remarks. You know, one of the things that I have seen, as all of my colleagues have seen across this country, is that opioid addiction is something that knows no barriers. It impacts everyone. It doesn't delineate, you know, how much money you have, what kind of family you were raised in, what race you are, whether you are a man or a woman. Addiction is that demon that knows no boundaries, in my humble opinion. And I am reminded of Vanessa, who we were able to assist through our office in the district, who was pretty much written off. Her parents pretty much adopted the tough love approach. And Vanessa came to us just recently after going through some very difficult times. And working with her parents, we were able to get her into a rehab situation. And her parents and her reunited, and at a town hall they were able to declare that she was opioid-free. That is a success story. And so when I see the new programs that are coming out of CMS--I know I only have 24 seconds left--the Overutilization Monitoring System shows that we went from 29,000 in 2011 down to 11,000 in 2016, for at-risk beneficiaries. That is a significant improvement. How are we going to enhance and promote that type of program even further and get that into the system? Ms. BRANDT. Well, we are continuing to constantly update that Overutilization Monitoring System. Most currently, we updated it to reflect the newest CDC guidelines. We have been very much focused on first-time opioid over-utilizers. And in fact, we have seen a 77 percent reduction in those since 2013, and we are continuing to use the work of our colleagues at GAO and the OIG and their recommendations to further refine our approach. Mr. REED. I appreciate that. And to all the Vanessas out there, I just say we stand ready across both aisles to join hands to serve their needs and address their addiction to get them into that healthy life. With that, I yield back. Chairman JENKINS. Mr. Curbelo is recognized for 5 minutes. Mr. CURBELO. Thank you, Madam Chairman, for this opportunity. And I thank all the witnesses. I am from South Florida, so regrettably, I have to raise the issue of healthcare fraud in this context, given that, unfortunately, we are known throughout the country for that issue. Mr. Cantrell, can you describe some of the types of fraud schemes that you see out there related to opioids? And if you have any examples that are specific or relevant to South Florida, I would appreciate those as well. Mr. CANTRELL. The fraud schemes, unfortunately, in many cases, we see them migrate from South Florida to other parts of the country. We found it to be a place where fraud schemes are born, in some instances. I know you know this, but that continues to be an important area for our work in healthcare fraud. But in terms of opioid-related fraud, it runs the gamut. We have seen situations where we have bad prescribers who are receiving kickbacks, who would write opioid prescriptions and also write prescriptions for other noncontrolled, high- expense drugs and get paid a kickback by a pharmacy. The pharmacy will dispense the opioid and never dispense the expensive drug, keeping all the profit that is paid by Medicare for that drug that was never even dispensed or medically necessary. That is one very egregious scheme. We have seen examples of physicians who have gone into business with known criminal networks, outlaw motorcycle gangs, for the sole purpose of illegally distributing Oxy's and pairing up with known drug dealers. Sometimes we call them marketers or patient recruiters. In this case, in this area of fraud, they are simply pairing up someone who wants the drug with a pharmacy who is willing to get the drug for a kickback in most of these situations. In some of these cases, this overprescribing leads to overdoses, and, unfortunately, sometimes an overdosed death for those who have been overprescribed. And so these schemes are not unique to South Florida. These are par for the course, and we are seeing these types of schemes around the country. Some of the things that we have seen in places like South Florida and New York are schemes related to HIV medications, which are very expensive. And so we have individuals who have HIV, need the medication, but are willing to, in essence, sell it back to a pharmacy for a kickback or sell it on the black market for a profit. So schemes like this, whether they are related to opioids or other expensive noncontrolled drugs, are certainly present in South Florida, but also in other areas of the country. Mr. CURBELO. And do you think that government is doing enough to mitigate this, to address this? Do you think that law enforcement has the resources to pursue these types of cases? Mr. CANTRELL. I will say that I don't think we have the law enforcement resources to address all the complaints that we have coming through our system. So there is more fraud out there than we are certainly able to address, given our resources. So what we do is utilize the data that we have available to us to maximize the use and the impact of the resources that we have. So we focus our efforts in places like South Florida, whether it is South Florida or somewhere in Indiana, wherever the highest impact or the most impactful fraud schemes are, where there are potentially patients at risk or where there is certainly lots of money being stolen, we will focus those resources, utilizing data and also intel from the street, if you will, allowing traditional law enforcement methods to focus on the right areas. There is, I think, more that we can certainly all do. And we have discussed some recommendations for CMS and identified many areas where they are going to improve their monitoring in this area, but it is a huge, enormous issue that requires resources and focus from a lot of different agencies. Mr. CURBELO. Thank you very much for that response. And I would just encourage all of my colleagues--we focus on the victims of opioid abuse, and we should because they are the ones suffering, but I think we also have to shine the light on the criminals and find a way to put a dent in all of these fraudulent schemes and operations that really open the door for so many vulnerable Americans to this type of addiction. So I thank you, and I hope that we can begin in South Florida, just a place where a lot of these schemes begin, that perhaps we can begin solving the problem there. I appreciate it. Chairman JENKINS. Mr. Paulsen is recognized for 5 minutes. Mr. PAULSEN. Thank you, Madam Chair, for putting this hearing together and for our witnesses today. We have all heard the stories of tragedies of opioids that are impacting real people. These are real families and very heartbreaking stories of addiction and death. It is no different in Minnesota. I mean, in 2016, the most recent year of data that we have, we have seen a 12 percent rise in opioid deaths over 2015. So Minnesotans are suffering through this epidemic as well, like so many other States. And one of the challenges that we have seen and had is that the theft of opioids from either pharmacies or even from people's trash has been occurring, where it is a problem due to outdated disposal techniques or information about how to properly dispose of opioids. So many people are now simply throwing them away and thinking nothing of it. Safe home disposal of unused and unwanted medications is one of the ways or tools to prevent theft and abuse from inappropriate access to these painkillers or prescription painkillers. We know that many people, including younger people, in particular, start on this path to addiction and overdose by stealing medications that are prescribed to others. So we have a company in Minnesota that I toured not long ago, Vertitech, that makes a very low-cost, easy-to-use, safe disposal bag that properly and completely disposes of opioids, patches and pills. It is a little different than going to a senior fair that I have hosted where maybe the Hennepin County sheriff comes in and they have a proper disposal technique or facility that is filled immediately with seniors who come in and dispose of their medications. So Ms. Brandt, let me just ask you, is CMS considering ways to help encourage Medicare and Medicaid beneficiaries to dispose of unused and unwanted medications as part of a more comprehensive strategy to confront this epidemic that we have? Or are you aware of the role that these drug deactivation bags can have in this space? Ms. BRANDT. Well, one of the interesting aspects of my job is that I get to meet with and talk to a lot of people. And as I mentioned earlier, one of the things we did last fall was have a number of stakeholder meetings. And as part of one of those stakeholder meetings, this topic came up, and there was actually quite an active discussion about the disposal of drugs. And one of the things that we talked about was the types of bags that you are describing and how effective those can be in environments. We also have heard from CVS, Walgreens, and several of the other pharmacies about ways that they have been doing things within their pharmacy networks to encourage that. So at CMS, one of the things we have been looking at is how we can partner with our partners at CDC, the Drug Enforcement Agency, and others to really work to educate beneficiaries about the safe disposal of opioids and other types of drugs and the full range of tools available to them to dispose of them. Mr. PAULSEN. That is great. I would encourage you to stay in touch with us or Members of Congress, obviously, to support this work that you are doing now around the safe medication disposal strategies that you are looking at, and certainly to partner with you. If there are any opportunities to do that, please let us know. Ms. BRANDT. Absolutely. It is always helpful for us to hear about the strategies that you all are seeing in your communities and then have that dialogue. And we will definitely keep in touch. Mr. PAULSEN. Thank you, Madam Chairman. I yield back. Chairman JENKINS. I recognize Mr. Kelly for 5 minutes. Mr. KELLY. Thank you, Madam Chair. And thank you all for being here. I think Mr. Reed hit on a lot of different aspects about the personal involvement that we all have. And knowing too much about it because of going through things personally. And the quote that is out there or the saying that says ``where we are all involved, we are either dependents or codependents.'' But what I wonder about is, I mean, this started, this war on drugs actually started back in 1970 with the opium wars, with President Nixon. And I think in the early 1970s, with President Reagan. Mrs. Reagan said to ``just say no'' and Mr. T said ``just say no.'' So I don't think it has been for a lack of concern, and it certainly hasn't been for lack of dollars that we have spent. I am in the automobile business. I don't want people to confuse what I am saying here. I am just saying that we do have the ability to track so many things. I mean, if you were to come into the dealership today and ask me about a car, I can tell you the complete warranty history on that car, everything that has been done to it. The question then becomes, if we have this ability, why aren't we able to incorporate it with people who prescribe drugs? And maybe it is because of the HIPPA Act, I don't know, but we have so much technology out there today that allows us to really get an in-depth look at who it is that we are talking about, what they are prescribing, and who is getting the benefits of this. So, Mr. Cantrell, I have heard from many healthcare providers who were frustrated with the HIPPA law that prevents their ability to coordinate care for substance disorder patients that are frequent fliers of their emergency departments. If the law were amended to allow care coordination, does HHS have a sense of how much Medicare, Medicaid, and private plans, that cost would go down? There is a tremendous--the totality of this is just overwhelming. And I think sometimes we get confused. If we could just throw more money at it, we could get it fixed. We have thrown so much money away and seen nothing but an increase. Is there a better way to use this data and to coordinate it? Mr. CANTRELL. We don't have any estimates of the impact of that sort of change, but I absolutely agree that there are more opportunities to utilize this data to more effectively manage this issue, this crisis. And for Medicare, we have fairly good, strong data related to opioid prescribing. In Medicaid, it is an area where we still lack visibility across the country, and it inhibits, we think, CMS' ability to oversee the Federal dollars that go out to Medicaid that relate to this opioid crisis, and it doesn't allow us to get a handle on the scope of the problem in Medicaid without going, in essence, State to State. There is a system that CMS is working on to improve the access to that Medicaid data, and we think, as they continue to improve that data and get timely, full, complete data from all 50 States, we will have--I don't know what we will see, but it will be enlightening as we do the same kind of analytics that we are doing in Medicare against the Medicaid. Mr. KELLY. I guess that is where I am coming from. Because I mean, and I really, I look at the private sector. I mean, if you wanted to--again, I am going to go back to what I do. If you wanted to find out if a car that you were looking to buy was ever involved in an accident, you go to the Carfax, and we have all seen this on TV. Why can't we go and find out exactly where the problem is? It just has to be there. These are prescriptions. And I see the numbers, and we have all this tracking of everything we have done, yet we can't coordinate it. We can't put the two together to help the people that really need it the most. And look, I know it is about the money. There is no question. What a huge economic model this is. And again, because I am too personally attached to it, it is not spending more money. We keep thinking that the idea is to spend more money. I think if we are spending more money, it is probably going to have to do with personnel, people like you that handle these things, that never quit on this. This is not a nine-to-five job. This is 24 hours a day that we all worry about it. I think the frustrating part, when we can separate ourselves from this, first of all, there is a huge loss for human beings. There is a huge loss in dollars that are being wasted because we can't connect the dots. We can't combine the information. I just don't know why we can do it so easily in the private sector with things that are just inanimate, but we can't do it where we are, when we are talking about human beings, being able to touch them, get them together and actually getting to know how we could serve them. And I don't know how much more it would cost because I think we don't have enough boots on the ground to see it. The other thing is this waste, fraud, and abuse; it is incredible what is happening on our watch right now. I wouldn't care what the cost was if it was actually going to help a patient or a person. I just think it is so sad that we are in a situation right now. And the President has declared it a national emergency. Pennsylvania has declared it a national emergency. We started in the 1800s knowing what the problem was. We have gone through this whole process. We are no closer to the answer today than we were way back in the opium wars. And I think that is the saddest part of it all. Where has it led? It is not because of the lack of investment or the lack of concern. How do we get to the point where we can actually connect this stuff so we don't have to worry about Vanessas or Jims or Bills or Marys that are out there today? It is just a tremendous loss in human potential and taxpayer cost. I thank you so much. Madam Chair, I thank you so much. And listen, what you are doing is incredible. I can tell you, I coached children's sports a lot in my life. I can't tell you the number of times I have been in a funeral home looking at some young person in a coffin, and around the room were pictures of them when they played for me at the Penn Street Cardinals or they played for me at our Little Marlins team. And I look at that, and I think, ``what happened to that little boy, what happened to that little girl, that they reached this point in their life.'' I think it is just so tragic. And it is not about the money. It is about the results. Please let's find a way to put this together so we can track it the right way. Thank you so much. I know I am way over my time, but I will tell you what, this is overtime. This goes back to the 1870s. And if we are no closer to a cure today than we were then, what was the whole purpose and the exercise? Thank you for staying on this and not giving up. Chairman JENKINS. Mr. Rice is recognized for 5 minutes. Mr. RICE. Thank you, Madam Chairman. I got a call from a friend of mine a couple of weeks ago about his daughter who had been arrested, and she had drugs on her person and is probably going to jail. I knew this young lady growing up. She grew up with my children. She played with my children. She is a fantastic, bright young lady who has just, her life is spiraling downward. And I read these statistics on South Carolina. Do you know the number of deaths from opioid abuse have doubled in the last 3 years? They surpassed traffic deaths a couple of years ago. The national statistics say opioid deaths killed 60,000 people last year, which is significantly more than if you combine homicides and traffic deaths nationally. So, and if you look at the graph, I mean, it goes from flat to straight up. It is not leveling off. We haven't peaked. It is just accelerating. So whatever we are doing, clearly it is failing. We are not doing enough. I look at how you, you know, what you guys do is try to track where there are problem users and attack that, or problem prescribers and attack that, but that is not working. I look at your definitions just from this hearing summary today that you consider a beneficiary at risk if they receive a daily dose of greater than 120 milligrams, get prescriptions from four or more providers, and fill prescriptions from four or more providers. Good grief. Good grief. I mean, clearly, if you have those three conditions combined, that is obviously a huge problem. In 2016, despite your efforts, despite these programs that you have put in place, you tell us a beneficiary in New Hampshire received 134 prescriptions for opioids from one prescriber, including 13 months of OxyContin, that is 80 milligrams; 13 months of OxyContin, 60 milligrams; 13 months of OxyContin, 40 milligrams; 14 months of oxycodone, 30 milligrams; and 13 months of fentanyl patches. You guys didn't catch that? Good grief. Whatever you are doing is not working. A beneficiary in Washington, DC received prescriptions for opioids from 42 different prescribers and filled them at 37 different pharmacies in a year. In a single month, this beneficiary received 2,330 pills from prescriptions written by just one prescriber. And we didn't catch that? You know, it is just overwhelming and depressing that we are so bad at this. One problem I see is what Mr. Kelly was referring to a minute ago, is the inability of the Federal Government to bring itself into the modern age of technology. I know, talking with folks on the IRS in this Subcommittee, talking with folks in Social Security, that they are still using Cobol and Fortran in a lot of their stuff, and they are using computers that have magnetic tape and all that, where everybody else left that behind, you know, decades ago. The IRS has 52 points of failure where only one person knows how to program these old computers. And if this person dies or retires, they don't know what they are going to do. Is CMS in that condition? Is CMS in such a bad shape, such a bad shape that it is impossible for them to accumulate and interpret the data that we are talking about? Ms. BRANDT. Well, we made numerous strides at CMS over the past several years, and particularly in the past 2 years, to really try to become more modern with our data. As Mr. Cantrell mentioned, one of the big developments that we have, which is going to go a long way toward helping us with having more of a full picture, is that we were seeing comprehensive Medicaid data from all of our States. One of the challenges we have---- Mr. RICE. What does that mean when you say---- Ms. BRANDT. That means---- Mr. RICE. You said you will soon have comprehensive Medicaid data from all of our States. That is a fascinating statement right there. What does that mean? Ms. BRANDT. Let me demystify it for you. That means at the current point in time we have over 46 States and our goal is to have all 50 States---- Mr. RICE. We have 50 States. Ms. BRANDT. Yes. We have 46 out of the 50 States that are currently reporting in their Medicaid data. We are working with the other four States to get all of that data in. And once we are able to have all of the States reporting in data in a consistent format, then we will be able to use that data to do more of the data analysis---- Mr. RICE. Okay. Can you do that by regulatory requirement, or would that require some legal, some legislation? Ms. BRANDT. This is all within our authority. We are using our regulatory authority to do that. Mr. RICE. And basically, you are going to say ``if you don't meet these benchmarks by this date, we are not going to pay for the prescriptions anymore,'' I hope? Ms. BRANDT. Well, that's true with part of this on the Medicaid side. And then on the Part D side of the house, Medicare Part D side, we work with the plan sponsors, who are the ones who actually receive the data. Mr. RICE. So have you given them benchmarks and set forth the timelines by which they have to meet those benchmarks? Ms. BRANDT. On the Medicaid side, we have. We have been working with them. They have deadlines they have to meet. And we are working with them to ensure that they are meeting those reporting deadlines. And on the Medicare Part D side, we consistently work with the plans to issue updated guidelines to make sure that they are reporting to us with as accurate information as possible. Mr. RICE. So what does that mean? That you haven't given them the guidelines? Ms. BRANDT. No, we have, but we update the guidelines on an ongoing basis. So, for instance, we just issued---- Mr. RICE. Are you getting the Medicare Part D information from all 50 States now? Ms. BRANDT. Well, that comes from the plan sponsors, not from the States. So the States provide us with Medicaid data, which is for drugs that are covered under Medicaid---- Mr. RICE. Okay. So from the plan sponsors, are you getting information---- Ms. BRANDT. Yeah. Mr. RICE [continuing]. From all 50 States? Ms. BRANDT. Well, the plan sponsors operate in all 50 States, but they, themselves, are the frontline. They are the ones who provide the point-of-sale data. Chairman JENKINS. The gentleman's time has expired. Mr. RICE. All right. I just want to ask one quick question. I know I am over time. Just one quick question. Mr. Cantrell, is there any legal impediment to you gathering this information from all 50 States? Because if there is, we need to fix that. What is that legal impediment, if there is one, and how do we fix it? Mr. CANTRELL. There is no legal impediment. Given the progress that has been made at CMS for doing this, it might not make sense for us to independently do it separately. So we are hoping to leverage CMS' effort to collect this data in all 50 States, but in order to do our work and do it independently, we have and continue to get data directly from the States---- Chairman JENKINS. Thank you, Mr. Cantrell. Thank you, Mr. Rice. The gentleman's time is expired. I would like to recognize the distinguished Member from Washington, Ms. DelBene, for a request. Ms. DELBENE. Thank you, Madam Chair. Congressman Lewis, the Ranking Member of this Subcommittee, was unable to join us today. And I would just like to ask unanimous consent to enter his opening statement into the record. Chairman JENKINS. Without objection, so ordered. [The submission for the Record of Hon. Suzan DelBene follows:] [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT] Chairman JENKINS. I would like to thank our witnesses for appearing before us today. Please be advised that Members have 2 weeks to submit written questions to be answered later in writing. Those questions and answers will be part of the formal hearing record. With that, the Subcommittee stands adjourned. [Whereupon, at 11:46 a.m., the Subcommittee was adjourned.] [Questions for the Record follow:] [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT] [all]
MEMBERNAME | BIOGUIDEID | GPOID | CHAMBER | PARTY | ROLE | STATE | CONGRESS | AUTHORITYID |
---|---|---|---|---|---|---|---|---|
Brady, Kevin | B000755 | 8164 | H | R | COMMMEMBER | TX | 115 | 1468 |
Davis, Danny K. | D000096 | 7927 | H | D | COMMMEMBER | IL | 115 | 1477 |
Kind, Ron | K000188 | 8216 | H | D | COMMMEMBER | WI | 115 | 1498 |
Larson, John B. | L000557 | 7866 | H | D | COMMMEMBER | CT | 115 | 1583 |
Thompson, Mike | T000460 | 7806 | H | D | COMMMEMBER | CA | 115 | 1593 |
Crowley, Joseph | C001038 | 8068 | H | D | COMMMEMBER | NY | 115 | 1604 |
Nunes, Devin | N000181 | 7826 | H | R | COMMMEMBER | CA | 115 | 1710 |
Sanchez, Linda T. | S001156 | 7844 | H | D | COMMMEMBER | CA | 115 | 1757 |
Higgins, Brian | H001038 | 8088 | H | D | COMMMEMBER | NY | 115 | 1794 |
Marchant, Kenny | M001158 | 8766 | H | R | COMMMEMBER | TX | 115 | 1806 |
Reichert, David G. | R000578 | 8212 | H | R | COMMMEMBER | WA | 115 | 1810 |
Buchanan, Vern | B001260 | 7885 | H | R | COMMMEMBER | FL | 115 | 1840 |
Roskam, Peter J. | R000580 | 7926 | H | R | COMMMEMBER | IL | 115 | 1848 |
Smith, Adrian | S001172 | 8040 | H | R | COMMMEMBER | NE | 115 | 1860 |
Jenkins, Lynn | J000290 | 7950 | H | R | COMMMEMBER | KS | 115 | 1921 |
Paulsen, Erik | P000594 | 8003 | H | R | COMMMEMBER | MN | 115 | 1930 |
Chu, Judy | C001080 | 7837 | H | D | COMMMEMBER | CA | 115 | 1970 |
Reed, Tom | R000585 | 8090 | H | R | COMMMEMBER | NY | 115 | 1982 |
Sewell, Terri A. | S001185 | 7792 | H | D | COMMMEMBER | AL | 115 | 1988 |
Schweikert, David | S001183 | 7802 | H | R | COMMMEMBER | AZ | 115 | 1994 |
Renacci, James B. | R000586 | 8106 | H | R | COMMMEMBER | OH | 115 | 2048 |
Kelly, Mike | K000376 | 8708 | H | R | COMMMEMBER | PA | 115 | 2051 |
Meehan, Patrick | M001181 | 8125 | H | R | COMMMEMBER | PA | 115 | 2052 |
Noem, Kristi L. | N000184 | 8147 | H | R | COMMMEMBER | SD | 115 | 2060 |
Black, Diane | B001273 | 8153 | H | R | COMMMEMBER | TN | 115 | 2063 |
DelBene, Suzan K. | D000617 | 8374 | H | D | COMMMEMBER | WA | 115 | 2096 |
Walorski, Jackie | W000813 | H | R | COMMMEMBER | IN | 115 | 2128 | |
Holding, George | H001065 | H | R | COMMMEMBER | NC | 115 | 2143 | |
Rice, Tom | R000597 | H | R | COMMMEMBER | SC | 115 | 2160 | |
Smith, Jason | S001195 | H | R | COMMMEMBER | MO | 115 | 2191 | |
Curbelo, Carlos | C001107 | H | R | COMMMEMBER | FL | 115 | 2235 | |
Bishop, Mike | B001293 | H | R | COMMMEMBER | MI | 115 | 2249 | |
LaHood, Darin | L000585 | H | R | COMMMEMBER | IL | 115 | 2295 | |
Doggett, Lloyd | D000399 | 8181 | H | D | COMMMEMBER | TX | 115 | 303 |
Johnson, Sam | J000174 | 8159 | H | R | COMMMEMBER | TX | 115 | 603 |
Levin, Sander M. | L000263 | 7997 | H | D | COMMMEMBER | MI | 115 | 683 |
Lewis, John | L000287 | 7902 | H | D | COMMMEMBER | GA | 115 | 688 |
Neal, Richard E. | N000015 | 7967 | H | D | COMMMEMBER | MA | 115 | 854 |
Blumenauer, Earl | B000574 | 8116 | H | D | COMMMEMBER | OR | 115 | 99 |
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