EXECUTIVE OFFICE OF THE PRESIDENT OFFICE OF NATIONAL DRUG CONTROL POLICY Washington, D. C . 20503 July 16, 2019 Austin Evers American Oversight 1030 15th Street, NW, Suite B255 Washington, DC 20005 Subject: FOIA Request Dear Mr. Evers: This letter responds to your request to the Office of National Drug Control Policy (“ONDCP”) under the Freedom of Information Act (FOIA). Your request has been designated as FOIA 2018046b. After a review of ONDCP records, we are providing you with the attached documents. ONDCP has made certain redactions as noted under FOIA exemptions 5 (relating to privileged inter-agency or intra-agency memoranda or letters) and 6 (relating to personnel and medical files and similar files the disclosure of which would constitute a clearly unwarranted invasion of personal privacy). See 5 U.S.C. §§ 552(b)(5), (6). If you are not satisfied with the action on this request, you may submit an appeal in writing. To be considered timely, it must be submitted electronically or postmarked (in the case of postal mail) within 90 calendar days from the date of this response via facsimile to (202) 395-5543 or via U.S. postal mail addressed to FOIA Appeals Officer, Office of National Drug Control Policy, Executive Office of the President, 1800 G Street NW, Washington, D.C. 20503. You also have the right to seek assistance from ONDCP’s FOIA Public Liaison at (202) 395-6622 or from the Office of Government Information Services (OGIS). OGIS offers mediation services to resolve disputes between FOIA requesters and Federal agencies as a non-exclusive alternative to litigation. Using OGIS services does not affect your right to pursue litigation. The contact information for OGIS is as follows: Office of Government Information Services, National Archives and Records Administration, Room 2510, 8601 Adelphi Road, College Park, Maryland 20740-6001; e-mail at ogis@nara.gov; telephone at 202741-5770; toll free at 1-877-684-6448; or facsimile at 202-741-5769. Thank you for your interest in learning about your government. Very truly yours, Michael Passante Deputy General Counsel Request for Department Views on Opioid Commission Report Recommendations From: "Baum, Richard J. EOP/ONDCP" ''Laverty, James F. EOP/ONDCP" To : Cc: "Talento, Kathryn F. EOP/WH_ O_ " ...--- "Passante, Michael J . EOP/ONDCP" Date : Thu , 02 Nov 2017 12:08 :52 -0400 Attachment Final_Report_Oraft_ 11-1-2017.docx (2.63 MB) ; REC SPREADSHEET Final s: Report.xlsx (21.75 kB) Dear Colleagues: I am writing to get your department 's feedback on the attached Final Report from the Commission. As you may know, the President appointed this bipartisan Commission (chaired by New Jersey Governor Chris Christie} to provide ·i ndependent advice to the federal government on how to address the opioid crisis. The Commission released its Final Report on November 1st, the full text can also be found on the Commission page of the ONDCP website here : https://www.whitehouse .gov/ondcp/presidents -commission The attached chart shows which recommendations from the Commission 's Final Report specifically involve your department, so I'm asking for your departmen t's feedback on those recommendation s only by Wednesday, Nov. 8th. I'm specifically interested in your feedback on: (1) whether your agency agrees with the recommendation, (2) what act ions if any your agency is already taking in that area or that cou ld be deemed responsive to the concern behind the recornmendation, and (3) what future actions your agency will be taking, or could be taking with enab ling legislat ion or additional funding. Please reach out to t he appropriate Wh ite House policy coun cils and the Off ice of Management and Budget for additional guidance, if necessary or appropria te . Your submitted comments will inform follow on actions throughout the government . Please let me know if you have any questions and tha nk you so much for your efforts on th is. Please copy Michael Passante (Designated Federal Officer for the Commission and Deputy Gener al Counsel at ONDCP) when prov idin g your feedback . Thank you, Richard Baum ONDCP006FY18004_ 000000045 ONDCP-18-0107-A-000001 Acting Director ON DC P006 8004_000000045 ON THE PRESIDENT'S COMMISSION ON COMBATING DRUG ADDICTION AND THE OPIOID CRISIS Roster of Commissioners Governor Chris Christie, Chairman Governor Charlie Baker Governor Roy Cooper Congressman Patrick J. Kennedy Professor Bertha Madras, Ph.D. Florida Attorney General Pam Bond i ONDCP006FY18004_000000046 ONDCP-18-0107-A-000003 Tab le of Contents Chainnan ' s Lett e r ..... ................ ..... . .. ........ ............... .... .... ........ . ........ ............ .... 5 Summary of Recommendations ............................ .......................... ............................................... The Drug Addjction and Opioi.d Cr isis ............................................................................. 12 ............. 19 Origins of the Current Crisis ........ ..... ........ ......... ........... ...................................... .......... ............. 19 Magnitude and Demographi cs .................................................................. ................................. 23 New ly Emerging Threats ........... ...................... ......................................... ........ ......................... 26 Pathway s to Opioid Use Di sorder (Including fleroin) from Prescript ion Opioids ...... .............. 27 Health , Financial , and Social Consequences ................ ..................................... ........................ 29 Dn1g Overdose Deaths ............... ....................... ........................................ ................................. 31 Substance Use Treatment AvaiJability ................. ........... .......... ................ ....... .......................... 32 Systems Approach to Solutions ........................ ............ ............................ ...... .......................... .35 Federal Fundin g and Program s ........ ........... ........................... ...... ................. ...... .............. ............. 37 Streamlining Federal Funding for Opioid s and Consideration of State Administrators ............ 37 Funding Effective Op ioid-Related Programs ............................. ...................... .......... ................ 38 Opioid Addiction Prevention ..... ................... ........... ..................... ................... ..............................40 Evidence-based Prevention Programs ............ ............................. .............................................. .42 SBIRT as a School Prevention Strate gy ............ ........................ .................... .................... .....43 Mass Media Pub lic Education Campaigns ..... ............ ............ ............. ........ ............ ...... ....... _.....44 Media Campaign Focusing on Opioids ............................................................................ ..... .46 Opio id Pre scription Practice s ............................ ........................................ ................................. 48 lmprovin g upon the CDC Guideline fo r Prescribing Opioidsfor Chronic Pain and Provider /Prescriber Education ................... ................. ..................... ...... ........ ........... .......... ....48 Enhancing Prescr iption Drug Morutoring Programs (PDMP) .............................. ..... ...... ..... .53 Pre scr iption Take-Back Program s and Drng Dispo sal.. ........ ................... ............ ..... ............. 55 Pain Level as an HHS Evaluation Criteria ................................. ..... .......................... ...... ........... 56 Reimbu rsement for Non-Opioid Pain Treatment s ..................... ................... ......................... ....57 Reducing and Addressi ng the Availability of Illic it Opioid s .................. ................................... 58 Improving Data Collection and Analytics ................... ....... ................. ................. .................. 58 Disrupting the Illicit Fentanyl Suppl y ....... .......................................... ........... ........... ............. 61 Interdi ction and Detec tion Challenges ........ ................ .................................. ................ ......... 63 Prot ecting First Re spo nders from Hannful Effects Resulting from Exposure to Fentanyl and other Synthetic Opioid s ........ ....................... .............................. .................... ....................... ..65 ON DCP006FY 18004 _ 000000046 ONDCP-18-0107-A-000004 Opi oid Addiction Treatment, Ove rdose R eversal, and Recovery ......... ............ ............................ 67 Dru g Addiction Treatment Services ............................... ........................................................... 67 Increase Screenin gs and Referrals to Treat ment through CMS Quali ty Measures ................ 67 Evidence- base d Impro ve ments to Treatment ................. ...... ............. ...................... ........... ....68 Tns man ce and Reimbur sement Barri ers to Accessing MAT ................... ................ ...............69 En forcing the Mental Health Parity and Addi ction Equi ty Act (MHP AEA) ...... ........ ....... .... 71 MAT in the Crimin al Justice System ............................ .......................................... ............. ..72 Drn g Courts and D iversion Pro gram s .......................................................................... .......... 73 Addi ction Services Workforce and Training Nee ds ................. ................. ............................. 74 Respon se to Ove rdose ................................... ................ ............................... .............. ................ 77 Expand ed Access and Adm inist ration of Naloxone .... ............................................... ....... ., ... 77 Overdose t o Treatm ent and Reco ve1y .................. .............. ...................... .................... .......... 79 Recove1y Support Services .............. ......... ..................... .............................. .............................. 80 Impa ct on Families and Childr en ............. ..................... .................... ........................... ..........80 Supp ortin g Colleg iate Recovery and Changing the Culnire on College Campu ses .... .......... 8 1 Employ ment Opp ortuniti es for Americans in Recove ry ........................... ................ ............ .83 Support Recove 1y Housing ..................... .............................................. ................................. 84 Rese arch & Deve lopm ent .................................. ................. .......................... ................................. 86 New Pain, Overdose, and MA T Me dications .................... ....................... ................................. 86 Medical Technology Devices ....... ..................... ............................................ ............................. 88 FD A Post-Ma rket Rese arch and Surve illance P rogram s ........................... ................... ............ .89 Co nclusion .......... .......... ................... ....................... ............. ............................. .............................90 Curr ent Fe deral Program s and Fundi ng Landsca pe .......... ...................... ............. ...... ........ ............ 93 Overview ............ ....................................... ....... ............... ............................. ................... ...........93 FY 201 8 Fundin g Specific to A merica's Op ioid Crisis ........... ................. ......... .. ........... ........... 93 The Comprehensive Addi ction and Recovery Act (CA RA) ........... ....................................... 96 2 1st Centu ry Cures Act ............................................................. .................. ............................96 FY 20 I 8 Consolidat ed Federal Drng Control Budget ......... ..................... ........... ............. .........97 Preve ntion ............. ..................................... ................ ...................... .................... ...................97 Treat:1nen t and Recovery , .............................. ..................... ......................... ..................... ...... 98 Domestic Law En forcement .................... ........... .......................................... ....... ................. 10 1 Interdiction .................... ......... ..................... ................. ........ ........................ ...... .................. I 02 International 5ffo rts ....... .......................................... ........ ................... ............... ......... ......... I03 lAPGl ON DCP006FY 18004 _ 0000 00046 ONDCP-18-0107-A-000005 Charter, President's Commission on Combating Drug Addiction and the Opioid Crisis ........... l07 Appendices .................................................................................................................................. l lO Appendix I . Acronyms ,. .................................. ................. .................................... .................. 110 Appendix 2. History of Opiate Use and Abuse .................. .................. ................................. .. 113 Appendjx 3. Interim Report , President's Commission 011 Combat ting Dmg Addiction and the Opioid Crisis .......................................................................................................................... .. 115 Appendix 4. Fentanyl Safety Recommendations for First Responders ........... ....................... 125 References ......... ........................................................................................ ................... ................ 126 IAPGl ON DCP006FY 18004 _ 000000046 ONDCP-18-0107-A-000006 THE PRESmEN'T 1S COMMiSSIO~ ON COMBATING DRUG ADDICTION AND THE OPIOID CRISIS Governor Chris Christie Chairman Governor Charlie Baker Congressman Pattick J. Kennedy Governor Flo'[ida Attorney General Pam Bondi Professor Roy Cooper Bertha Madras, Ph.D. November I , 2017 The Honorable Donald J. Tmmp President of tbe United States The White House 1600 Pennsylvania Ave nue NW Washington , DC 20500 Dear President Trump , On behalf of the Presjdent's Commission on Combating Drug Addjction and the Opioid Crisis, we thank you for entrusting us with the responsibility of developing recommendations to combat th e addiction cris is that is rampantly impacting our country. Your speech in the East Room of the White House , a long with the remarks of the Fir st Lady , made it clear to the country that fighting tbis epidemic is a top priority of your Adm inistration. On behalf of the Commissio n, we thank you for your leadership on this issue and on the clarity of your call to action. When you declared the opioid crisis a national public health emergency under federal law on October 26, 2017, you acknowledged th is crisis as one of epic prop01tion , impacting nearl y every conun unit y across all 50 states. You signaled to the country that the force of the federal gove rnm ent sho~ ld and wi ll mobi lize to reve rse the ris ing tide of overdose death s. You gave the millions of Americans fighting addiction hope that we can overcome this crisis, and we are prepared to w in the fight . Mr. President , as you acknowledged w hen yo u addressed the nation last week ., the rea son behind the urgent recommendations presented to you today by thi s Commission is that the leading cause of unintentional death in the United States is now drug overdose deaths. Our people are dying. More than 175 lives lost every day. If a terror ist organization was killing 175 Americans a day on Amer ican soil , what would we do to stop them? We would do anything and everything. We must do the same to stop the dying caused from witl1in . J know you will. IAPGI ON DCP006FY 18004 _ 000000046 ONDCP-18-0107-A-000007 THE PRESmEN'T1S COM?v1IS'S10N ON COMBATING DRUG ADDICTION AND THE OPIOID CRISIS Governor Chris Christie Chairman Governor Charlie Baker Congressman Patrick J. Kennedy Governor Florida Attorney General Pam Bondi Professor Roy Coopet Bertha Madras, Ph. D. Without comprehensive action , includin g your nationaJ pub lic health emerge ncy, the death count will continue to rise. l know that is unacceptable to you. l know you will win this fight for the peop le who elected yo u. IAPGI ON DCP006FY 18004_ 000000046 ONDCP-18-0107-A-000008 You've met hundreds of parents who have buried their children , so these numbers are 110 longer simp ly statistics. Instead , they represent the injured student-athlete who becomes addicted after first prescription, ending her academic and athletic career, the newborn infant who is red and screaming from withdrawal pain, the grandparents using their retirement savings to raise young kids when the parents can' t, the mom who just buried her only son, and the addict who cycles in and out of jail , simply because without access to treatment be is unable to stay sober and meet the terms of his parole. l t is time we all say what we know is true: addiction is a disease. However , we do not treat addiction in this country Jike we treat other diseases. Neither government nor the private sector has committed the support necessary for research , prevention , and treatment like we do for other diseases. The recommendations herein , and the interim recommendations subm itted by the Commission in July, are designed to address this national ptiority. These recommendations will help doctors, addiction treatment providers , parents, schools , patients , faith-based leaders, law enforcement , insurers , the medical industry, and researchers fight opioid abuse and misuse by reducing federal barriers and increasing support to effective programs and irmovation. Obviously , many of the recommendations that follow wm require appropriations froh1 Congress into the Public Health Emergency Fund, for block grants to states and to DOJ for enforcement and judicial improvements. Tt is not the Comm ission's charge to quantify the amount of these resources , so we do not do so in this report. You have made fighting the opioid epidemic a national priority , Mr. President. And , the country is ready to follow your lead. Now , we urge Congress to do their constitutionally delegated duty and appropriate sufficient funds (as soon as possible) to impleme11t the Commission's recommendations . 175 Americans are dying a day. Congress must act. Here is what yonr Administration has already done: • • • You acted to remove one of the biggest federal barriers to treatment by announcing the launch of a new policy to overcome the restrictive, decades-o ld federa l rnle that prevents states from providing more access to care at treatment facilities with more than 16 beds. This action will take people in ctisis off waiting lists where they are at risk of losing their battle to their disease and put them into a treatment bed and on the path to recovery. We urge all Governors to apply to CMS for a waiver. This policy will - without an.y doubt save lives. Governors across this nation thank you for listening to our call for help . 1n the interim report, the Commission also called for prescriber education and enhanced access to medication-assisted treatment for those already suffering from addiction. You acknowledged the need for these recommendations and directed all federally employed prescribers to receive special training to fight this epidemic . This is a bold step by you to deal with this issue. We recommended that the Department of Justice, which has already acted forcefully to stop the flow of illicit synthetic drugs into this country through the U.S . Postal Service, [APGl ON DCP006FY 18004_ 000000046 ONDCP-18-0107-A-000009 • continue its efforts. The aggressive enforcement action being taken by your Administration is critical in on.r efforts to reduce the rise of overdose deaths in this country . National Institutes of Healtl.1(NIH) Director DL Francis Collins has been partnering with pharmaceutical compan ies to develop non-addictive painkillers and new treatmen ts for addiction and overdose. The Commission worked with Dr. Collins to convene a meeting with industry leadership to discuss innovative ways to combat the opioid crisis. The Commission also held a public meeting to highlight the progress and umovation occurring today resulting from the NlH ' s work.. This type of sc ientific progress is a positive step to help free the next generation from the widespread suffering addiction is causing today . Otu- interim recommendations called for more data sharing among state-based presc ription drug monitoring programs and recognized the need to address patient pr ivacy regulations that make it difficult for health providers to access information and make informed h~althcare decisions for someone who has a substance use disorder. We recommended that all law enforcement officers across the country be equipped with life-saving naloxone. Finally, we recommended full enforcement of the Mental Health Parity and Addiction Equity Act to ensure that health plans cannot provide less favorable benefits for mental health and substance use diagnoses than physical health ailments. You will see further recommendations in our final report regarding the Parity Act and calling for the Department of Labor to have enhanced penalty and enforcement powers directly against insurers failing those who depend on them for life-saving treatment. All the interim recommeJ1dations remain extremely relevant today and are critical tools to reduce ever increasing overdose death s plaguing our citizens . The Commission is grateful the Administration has begun the hard work of implementing these initiatives. We urge you to implement the others as soon as possible. Today , the Commission , as one its most urgent recommendations among the more than 50 provided in the final report , is calling for an e.xpansive national multi-media campaign to fight this national health emergency . This campaign , including aggressive television and social media outreach , must focus on telling our children of the dangers of these drngs and addiction, and on removing stigma as a barrier to treatment by emphasizing that addiction is not a moral fai ling, but rathe r a chronic brain disease with evidence-based treatment options. People need to be aware of the health risks associated with opioid use, and they must stop being afraid or ashamed of seeking help when facing their add iction. Today , only 10.6% of youth and adults who need treatment for a substance use disorder receive that treatment. This is unacceptable. Too many people who could be helped are falling through the cracks and losing their lives as a result. Many states , incl.uding my State of New Jersey , have undertaken this media strategy with significant positive results. However , having a nation-wide campaign will serve to reinforce the message and ensure , for example , that yot1th and young adults no longer believe that experimen ting with pills from a doctor is safer tl1an experimenting with illega l substances from a drug dealer. As part of its prevention recommendations , the Commi.ssion also calls for better educating fAPGl ON DCP006FY 18004 _ 000000046 ONDCP-18-0107-A-000010 middle schoo l, high school , and co llege students witl1 the help of trained professionals s uch as nur ses and counse lors who can assess at-risk kids . Chi ldren have not escaped the consequences of addiction and our effort s to reduce overdose deat hs must start early. Mrs. Trump 's dedication and leadership io help ing our nation_'s children will make this a top pri ority and help save innocent yo ung lives . One of the mo st importan t recommendations in this final report is getti ng federal funding support more qui ckly and effective ly to state govern ments , who are on the fro nt lines of fighting this addiction battle every day. Bur eaucracy , departmental silos, and red tape must not be accep ted as the nonn when dea ling with funding to combat this epidem ic . Sav ing time and reso urces, in this instance , will literally save lives . Acco rdin gly , we are urging Congress and the Admini stratio n to block grant federal fund.ing for opioid-related and SUD- related activities to the states. There are mu ltiple federal agencies and multiple grants w ithin those agencies that cause states a significant administrati ve burden from an application and reporti ng perspective. Money is being wasted and accountability for results is not as intense as it sho uld be. Block grantin g them wou.ld allow more resources to be spe nt on administering life-saving programs . This was a request to the Comm ission by nearly every Governor , regardless of party , across the country. And as a Commission that has three governors as members , all of whom know the frustration of jumping through multiple hoops to receive the fund ing we need to help our constitue nts in this fight , we wholehea11edly agree. Throughout the co mprehens ive reco mm endations of its final report , the Commi ssion also ident ifies the need to focus on, depl oy and assess evide nce -based programs tha t ca n be funded through these proposed block grants. Many of the recommendations acknowledge a need for better data analysis and accountabi lity to ensure that ahy criti cal dollars are speht on wha t works best to fight this disease. From its re view of the federal budget aimed at address ing the opioid ep idemic , the Co mmiss ion identified a disturbing tre nd in federal health care re imbu rsemen t policies that incentivizes the wide-spread prescribi11g of opioids and limits access to other non-addictive treatments for pa iD, as we ll as addiction treatment and med ication-a ssisted treatme nt. First , indi vidual s w ith acute or chronic pain m ust ha ve acces s to non-opioid pain mana gement options . Everything from physical therapy , to non-opioid medicatio ns, shou ld be easi ly accessible as an alternative to opioids. The Com mission heard frotn many fonovative life scie nces films with new and promi sing products to treat patients ' pain in non-addictive , safe r ways; but they have trouble competing w ith cheap , ge neric opioids that are so w ide ly used. We should incentivize insurers and the government to pay for non-op ioid treatme nts for pain beginning right in the opera ting roo m and at every trea tment step alo ng the way. In some cases , non-addictive pain medica tions are bundled in federal reimbursement policies so that hospitals and doctors are essent ially not covered to prescribe non-opioid pain management alternatives. These types of poli cies, which the federa l government can fix, are a significant deterrent to tu.rning the tide on the hea lth crisis we are fac ing. We urge you to order HHS to fix it. JAPGl ON DCP006FY 18004 _ 000000046 ONDCP-18-0107-A-000011 Second , as a condition of full reimbursement of hospitals, CMS requires that hospitals randoml y survey discharged patients. HHS pre viously included pain question response infomrntion in calculations of incentive payment. but in 20 l 7 thankfully abandoned this practice. However , all pain survey questions were not withdra wn from the surveys. The Commission recommends that CMS remove pain questions entirely when assessing conswners so that providers won't ever use opioids inapprop riately to raise their survey scores. We urge you to order HHS to do this immediately. The expectation of eliminating a pati ent' s pain as an indjcation of s11ccessful treatment , and seeing pain as the fifth vital sign, which has been sta ted by some medical profe.ssionals as uniqu e to the United States, was cited as a core cause of the culture of overprescribing in this country that led to the current health crisis. This must end immediately. The Department of Labor must be given the real authority to regulate the healt h insurance industry. The health insurers are not following the federal la w requiring parity in the reimbursement for mental health and addiction. They must be held responsible. The Secretary of Labor testified he needs the ability to fine vio lators and to individually investigate insurers DOtjust employers . We agree with Secretary Acosta. If we do not get Congress to give him these tools, we will be failing our mission as badly as health insurance companie s are failing their subscribers on this issue today leading to deaths. Also contribut ing to this problem is the fact that HHS/CMS , the Indian Hea lth Service, Tricare, and the VA still have reimbursement barriers to substance abuse treatment , including limiting access to certain FDA-approve d medication-assisted treatment , counseling, and inpatient/residential treatment. It's imperative that federal treatment providers lead the way to treating addiction as a disease and rernove these barrier s. Each of these primary care pro viders employed by the abovementioned federal health systems should screen for SUDs and, directly or through referral, pro vide treatment within 24-to-48 hours. Each physician employee should be able to prescribe bupren orphine (if that is the most appropriate treatmen t for the patient) in primaty care settings. As President, you can make this happen immediately. We urge you to do so. A good example of this federal leadership occurred when Department of Veterans Affairs Secretary Shulkin , in response to the Commission' s interim report release , immediat ely launched eight best practices for pain mana gement in the VA health- care system. These guidelines included everything from alternatives and complimentary care, counseling and patient monitorin g to peer education for front-line pro viders, infonn ed conse nt of patients and naloxone distribution for Veterans on long-term opioid therapy. 1 had the opportunity to visit with doctors and patients at the Louis Stok es Northeast Ohio VA Healthcare System and witnessed first-hand the positive re-5ults of a hospital that has embraced a different cm1tinuum of care for pain management. The VA doctors, which included behavioral health specia lists, acknowledge and treat those with addiction in the full complem ent of ways the medical community would tackle other chronic diseases. Let' s use these VA practices as an example for our entire healthcare system. As you wiJl see in the Conuni ssion' s recommendations , the Federal Gove rnment ba s a number of avenues through which it can ensure that individuals with addiction djsorders get the fAPGl ON DCP006FY 18004 _ 000000046 ONDCP-18-0107-A-000012 help they need; iucluding changing CMS reimbursement policies , enforcing parity laws against non-compliant insurers , promoting access to rural communities through such tools as telemedicine , and incenting a larger treatment workforce to address the broad scope of the crisis. For individuals with a substance use disorder , ensuring life-saving access to affordable health care benefits is an essential tool in fighting the opioid epidemic. Look at Indiana as an example. After Indian a used an insurance access program to rapidly respond to a rural , opioidrelated health crisis , the lndiana Department of Health reported that such a program opened the door to life changing medical tTeatment. We are recommending that a drug court be establ ished in every one of the 93 federal district courts in Ameiica. ft is work ing in our states and can work in our federal system to help treat those who need it and lower the federal prison population. For many people . being arrested and sent to a drug comt is what saved their lives, allowed them to get treatment , and gave them a second chance. Dru g Courts are known to be significantly more effective than incarceration , but 44% of U.S. Counties do not have an adult drug court. DOJ should urge states to establish state drug courts in every county. When individuals vio late the terms of probation or parole with substance use , they need to be diverted to drug court , rather tha o back to incarceration. Further , drug courts need to embrace the use of medication-assisted treatmen t for their populations , as it clearly improves outcomes. The crimi nal justice system should accept that medication , when clinically appropriate , can lead to lasting recovery ~abstinence-only sobriety is not the only path to recovery. Lastly , the Commission ' s recommendations identify multiple ways to reduce the supply of licit and illicit opioids and enhanced enfo rcement strategies. Recognizing the growing threat of synthetic opioids such as fentany l, the Commission recommends enhanced penalties for trafficking of fentanyl and fenta.nyl analogues and calls for additional technologies and drug detection methods to expand efforts to intercept fentanyl before entering the country. To help protect first responders , who are also on the front lines fighting this epidemic responding to overdoses sometimes multiple times a day , the Commission recommends the Wh ite House develop a national outreach strategy coordinating with Governors for the release and adoption of the Office of Homeland Security Natio nal Secu rity Counci l' s new Fentanyl Safety Recommendations for First Responders. Th e Commission thanks White House Homeland Security Advisor Tom Bossert for his support and hard work already on this initiative. Many other thoughtful, vital recommendations are included herein. Th ese recommendations were informed by expert testimony provided during the Commission's public meetings , which included treatment providers and experts , pharmaceutical innovators and insurers. They also were informed by thousands of written submissio ns accepted by the Commission as part of its public process. The Comm ission acknowledges that there is an active movement to promote the t1se of marijuana as an alternative medication for chronic pain and as a treatment for opioid addiction. Recent research out of the NIH 's National Institute on Drug Abnse found that marijuana use led to a 2 ½ times greater chance that the marijuana user would become an opioid user and abuser. IAPGl ON DCP006FY 18004 _ 000000046 ONDCP-18-0107-A-000013 The Comm ission found thi s very disturbing. There is a lack of sophist icated outcome data on dose , potency , and abuse potential for marijuana. This minsors the lack of data in the l 990's and ear ly 2000 ' s when op ioid presc ribing multipl ied across health care sett ings and led to the current epide mic of abuse , misuse and addiction . The Commi ssion urges that the same mistake is not made with the uninformed rush to put another drug legally on the market in the midst of an overdose epidemic. The Commi ssion extends our sincere gratitude to all of the individuals, organizatio ns, familie s, companies, state offic ials, federa l agency staff , and clinical profess ionals who provjded personal stories, creative solut ions, and thoughtful input to the Commi ssion. The Commission members received thousands of letters, took hundr eds of phone calls and meetings , and heard testimony fro1u prominent organizatjons including non-pi:ofits, professional socie ties. pharmaceutical companies , health insurance providers , and most importantly , individuals and famil ies that have been in the throes of addiction. These letters, conversations , and meetings were the impeh1s for the vast majority of recommendations made in tl1isreport. The Commi ssion is confident that, if enacted quickly, these recommendations will strengthen the federnl government. state , and loca l response to this crisis. But it will take all invested parties to step up and play a role: the federal exec utive branch, Congress , states , the pharmaceutical industry , doctors , phar macists, acade mia, and insurers. The respons ibil-ity is all of ours. We must come together for the co llective good and acknowledge that this disease requires a coord inated and comprehensive attack from all of us. The time to wait is over . The time for talk is passed. 175 deaths a day can no longer be tolerated. We know that you wrn not stand by ; we believe you will force action. Along with my fellow Commi ssion member s, and the thousa nds of people who contributed to this report by sharing their stories and ideas for solutions. 1look forward to seeing these policy cbru1ges implemented. Thank you again for the opportu ni ty to serve, and most of all thank you for your comm itment to addressing th is vital national public health emergency. Sincerely, Governor Chri s Christie Governor of New Jersey Chaim1an, President's Commission on Com bating Drug Addiction and the Opioid Crisis IAPGl ON DCP006FY 18004 _ 000000046 ONDCP-18-0107-A-000014 Summary of Recommendations Federal Funding and Programs l. Th e Commission urges Congress aud the Adm inistration to blo ck grant federal fi.mding for opioid-related and SUD-re lated activities to the states , where the battle is happening every day. There are multiple federal agencies and multiple grants within those agencies that cause states a significant administrative bu rden from an application and reporting perspective. Creating tu1.ifonn block grants wou ld allow more resources to be spent on administer ing 1ife-savi11g programs . This was a request to the Commission by nearly every Governor , regardle ss of party , across the cotmtry . 2. Th e Comm ission believe s that ONDCP mu st establish a coordinated system for tracking all federa lly-funded initiatives , through support from HHS and DOJ . If w e are to inves t in combating this epidemic, we mu st invest in only those programs that ach ieve quantifiable goa ls and metrics. We are operating blindl y today ; OND C P must estab lish a system of tracking and accountability . 3. To achieve accountability in federal programs , the Co mmis sion recommend s that ONDCP review is a component of every federal program and that uecessa1y funding is provided for implementation . Cooperation by federal agenc ies and the states mu st be mandated. Opioid Addiction Prevention 4. Th e Conunission recommends that Department of Education (DOE) collaborate with states on student assessment pro grams such as Screening , Brief llltervention and Referral to Treatment (SBIRT). SBfRT is a program that uses a scree nin g tool by trained staff to identify at-risk youth who may need treatment. TI1is should be deplo yed for adolescents in middle school, high sc hool and college leve ls. This is a sig nificant pre ve ntion tool. 5. Th e Commission recommend s th e Administra tion fond and co llaborate with private sector and non-profit pru1ners to de sii::,•n and impl ement a wide-reaching , national multi-platform media campaign addressing the hazards of substance use , the danger of opioids, and stigma. A similar mass media/educational campaign was launched durin g the AlDs public health crisis. Prescribing Guidelines. Re-sulatio11s. Education 6. The Co mmission recommends HHS , the Department of Labor (DOL) , V NDOD , FDA , and ONDCP wo rk wi th stakeholder s to deve lop mode l sta tutes , regulati ons, and policies that ensure informed patient co nsent prior to an opioid prescr iption for chronic pain . Patient s need to understand the risks , bene fits and a lternatives to takin g opioids. This is not the standard today. 7. The Commission recommend s that HHS coordinate the development of a national curriculum and standard of care for opioid prescribers . An upd ated set of gu ide lines for prescription pain medication s should be established by an expett co mmittee composed of various specialty [APGl ON DCP006FY 18004 _ 000000046 ONDCP-18-0107-A-000015 practic es to suppleme nt the CDC gu ide line that are specifically targeted to ptimary care phy sicians. 8. The Commission recommends that federal agencies work to collect participation data. Data on prescribing pattern s should be match ed wit h participation in continuing medical education data to determine program effectiveness and such analytics shared with clinicians and stakeholders such as state licensing boards. 9. The Co mmi ssion recommends that the Admini stration deve lop a model training program to be disseminated to all leve ls of medical ed ucation (includi ng all prescribers) on screening for substance use and mental health stams to identify at risk patients . IO. The Commission recommends the Administration work with Co ngress to amend th e Con trolled Substances Act to allow the DEA to require that all pres criber s desiring to be relicen sed to pres crib e opioids sho w participation in an approved continuin g medical education program on opioid prescribing. 11. Th e Commission recom mends that HH S, DOJ /DEA , ONDCP , and pharmacy assoc iati ons tra in pharmacists on best practice s to eva luate legitimac y of opioid prescription s, and not penalize pharmacist s for denyin g inappropr iate pre scriptions. PDMPEnhancements 12. The Commission recommends the Administratio n' s support of the Prescription Drug Moni toring (POMP) Act to mandate states that receive grant funds to comp ly w ith PDMP requirements , including data sharing. Thi s Ac t directs DOJ to fund the establ ishme nt and maintenance of a data -sharing hub. 13. The Commission recommend s federal agenc ies mandate POMP che cks , and cons ider amending requirements under the Emergency Medical Treatment and Labor Act (EMT ALA) , whic h requires hospitals to screen and stabi lize patient s in an emergency department , regardless of insurance status or ability to pay . I 4. The Comm ission recommends that PDMP data integration with electronic health records, overdose episodes , and SUD-related deci sion support tools for pro viders is nec essary to increa se effectiveness. 15. Th e Commission recommends ONDCP and DEA i11crease electronic prescribing to prevent diversion and forgery . The DEA sho uld revise regulati on s regarding electronic prescribing for co ntrolled substances. 16. Th e Commission recommends that the Federal Government work w ith states to remove legal barriers and en sure PDMPs incorporate ava ilable overdose /oaloxone deployment data , incl uding the Department of Tran spo rtation 's (DOT) Emergency Medical Tech nician (EMT ) overdose databa se. It is nece ssa1y to have overdos e data /nalo xone deplo yment data in the POMP to aJlow user s of the POMP to assist patie nts. IAPGI ON DCP006FY 18004_ 000000046 ONDCP-18-0107-A-000016 Supply Reduct ion and Enforcement Strateg ies 17. The Commission recomm ends commu nity-based stakeholders utilize Take Back Day to infonn the p ublic about drug screening and treatment services. Tbe Comm ission encourages more hospitals/clin ics and retai l pharm acies to beco me year-r ound authorized collectors and explore the use of drug deactivation bags. 18. The Commi ssion recommend s that CMS remove pa in survey questions entirely on patient satisfact ion surveys , so that prov iders are never incentivized for offeri ng opioids to raise their survey score. ONDCP and HHS should establish a policy to prevent h ospital adm inistrators from using patient ratings from CMS surveys improperly. 19. The Com miss ion recommends CMS review and modify rate-setting policies that discourage the use of non-opioid treatments for pain, such as ce11ain bund led paymen ts that make alternative treatment options cost prohibitive for hosp itals and doctors , particularly those options for treating immediate post-surgical pain . 20. The Commiss ion recomme nds a federal effort to strengthen data collection activities enabling real-time surveillan.ce of the opio.id crisis at the national, state, local, and tribal levels. 21. The Commiss ion recommends the Federal Governme nt wor k with the states to develo p and impl ement standardized rigorous drug testing pro cedures, forensic methods, and use of app ropri ate tox icology instrumentation in the investigation of drug-related deaths. We do not have sufficiently accurate and systematic data from medical exa miners around the co untry to detennin e overdose deaths, both in their cause and the actua l number of deaths. 22 . The Comm ission recommends reinstituting the Arrest ee Drug Abuse Monitoring (ADAM) progra m and the Drug Abuse Warning Network (DAWN) to improve data collection and provide resources for other prom ising surve illance systems. 23. The Commission recommends the enhancem ent of federa l sen tencing penalties for the trafficking of fent anyl and fentany l analogues . 24. The Commi ssion recommends that federal law enforcement agencies ex pressly target Drug Tra fficking Organ izations and other individuals who produce and sell counterfeit pills, including through the internet. 25 . The Commi ssion recomme nds that the Adm inistration work w ith Congress to amend the law to give the D EA th e authority to regulate the use of pill presses/tableting mach ines with requirements for the maint enance of recor ds, inspections for ve rifyin g location and stated use, and security provisions. 26. The Commi ssion recommends U.S. Custo ms and Border Protection (CBP) and the U.S . Postal Inspection Service (US PIS) use add itional technologies and dni g detection canines to expand efforts to intercept fentanyl (and other synthetic opioids) in envelopes and pac kages at international mail process ing distribution centers, 27. The Co mmi ssion recommends Congress and the Federal Gove mm ent u se advanced electronic data on international shipm ents from high-risk areas to identify international suppliers and their U.S.-based distributors. IAPGl ON DC P006FY 18004 _ 0000 00046 ONDCP-18-0107-A-000017 28. The Commission recommends support of the Synthetics Trafficking and Overdose Prevention (STOP) Act and recommends the Federal Government work with the international community to implement the STOP Act in accordance with international laws and treatie s. 29. The Commissio n recommends a coordinated federal/DEA effort to prevent , monitor and detect the diversion of prescription opioids , including licit fentanyl, for illicit distribution or use. 30. The Commission recommends the Wh ite House develop a national outreacJ, plan for the Fentany l Safely Recommendations for Firs/ Respond ers. Federal departments and agencies shou ld partner with Governors and state fusion centers to develop and standardize data collection, analytics , and information-s haring related to first responder opioid-in toxication incidents . Opioid Addiction Treatment, Overdose Reversal, and Recovery 3 L. The Commission recom mends HHS, CMS, Substance Abuse and Mental Health Services Administration , the VA, and other federal agencies incorporate quality measures that address addiction screenings and treatment referra ls. There is a great need to ensure that health care providers are screening for SUDs and know how to appropriately counsel , or refer a patient. HHS should review the scientific ev idence on the latest OUD and SUD treatment options and collaborate with the U.S. Preventive Services Task Force (USPSTF) on provider recommendations. 32. The Commiss ion recommends the adoption of process, outcome , and prognostic measures of treatment services as presented by the National Outcome Measurement and the American Society of Addictjon Medicine (ASAM) . Addiction is a chronic relapsing disease of the brain which affects multiple aspects of a persou's life. Providers, practitioners , and funders often face challenges in helping individuals achieve positive long-tenn outcomes without relapse. 33. The Commission recommends HHS/CMS , the Indian Health Service (IHS) , Tricare , the DEA , and the VA remove reimbursement and policy barriers to SUD treatment , including those , such as patient limits, that limit access to any forms of FDA-approved medication-assisted treatment (MAT) , counseling, inpatient/resident ial treatment , and other treatme nt modalities , part icularly fail-first protocols and frequent prior authorizations . All primary care providers emp loyed by the above-mentioned health systems should screen for alcohol and drug use and, directly or through referra l, provide treatment within 24 to 48 hours. 34. The Commission recommends HHS review and modify rate-setting (including policies that indirectly impact reimbtirsement) to better cover the true costs of providing SUD treatment, including inpat ient psychiatric facility rates and outpatient provider rates. 35. Because the Department of Labor (DOL) regulates health care coverage provided by man y large employers , the Commission recommends that Congress provide DOL increased authority to levy moneta ty penalties on insurers and funders , and permit DOL to launch investigations of health insurers independently for parity vio lations. 36. The Commissio n recommends that federa l and state regulators shou ld use a standardized tool that requires health plans to docmnent and disclose their complianc e strategies for nonquanti tative treatment limitations (NQTL) parity. NQTI.,s include stringent prior authorization [APGl ON DCP006FY 18004 _ 000000046 ONDCP-18-0107-A-000018 and medical necessity requi rements. HHS , in consu ltation with DOL and Treasury , should review clinica l guidelines and standards to support NQ TL parity requirements. Private sectm insurers , includi ng employers , should revjew rate-setting strategies and revise rates when necessary to increase their network of addiction treatment professionals. 37. The Comm ission recommends the Natio nal Institute on Corrections (NlC) , the Bureau of Justice Assistance (BJA), the Substance Abuse and Mental Health Services Adm inistration (SAM HSA) , and other national , state, local , and tribal stakeholders use medication-assis ted treatment (MAT) with pre-trial detainees and continuing treatment upon release. 38. The Commission recommends DOJ broadly estab lish federa l drug courts within the federal district court system in all 93 federal judicial districts. States , local units of government, and Indian tribal governments shou ld apply for drug court grants established by 34 U.S. C. § I 0611. Individuals with an SUD who violate probation te011s with substance use should be diverted into dmg court , rather than prison. 39. The Commissio n recommends the Federal Government part11erwith appropriate hospital and recovery organizations to expand the use of recovery coaches, especially in hard-hit areas. Insurance companies , federal health systems , and state payers should expand programs for hosp ital and primary case-based SUD treatment and referral services. Reco very coach programs have been extraordinarily effective in states that have them to help direct patients in crisis to appropriate treatment. Addiction and recovery specialists can also work with patients through technolo 6,y and telemedicine , to expand their reach to underserved areas. 40 . Tbe Commission recomJneods the Health Resources- and Services Admini stration (HRSA ) prioritize addict ion treatment knowledge across all health disciplines. Adequate resources are needed to recruit and increase the number of addiction-trained psychiatrists and other physicians , nurses, psychologists , socia l workers , phys ician ass istants , and com1mmity health workers and facilitate deployment in needed regions and facilities_ 41. The Commission recommends that federal agencies revise regulations and reimbursement policies to allow for SUD treatment via telemedicine. 42. The Commission recommends further use of the National Health Service Corp to supply needed health care workers to states and localities with higher than average opioid use and abuse . 43. The Commission recommends the National Highway Traffic Safety Administration (NHTSA) review its National Emergency Medical Services (EMS) Scope of Practice Model with respect to naloxone , and dissemina te best practices for states that may need statutory or regulatory changes to allow Emergency Medical Technicians (EMT) to administer nalox.one, including higher doses to account for the rising number of fentanyl overdoses . 44. The Commission recommends HHS implement naloxone co-prescribing pilot pro&'Tamsto confirm initial research and identify best practices. ONDCP should. in coordin ation with HH S, disseminate a summ ary of existing research on co-prescribing to stakeholders. 45. The Commission recommends HHS develop new guidance for Emergency Medical Treatment and Labor Act (EMT ALA) comp liance with regard to treat ing and stabi lizing SUD patients and provide resources to incentivize hospitals to hire appropriate staff for their emergency rooms. IAPGl ON DCP006FY 18004 _ 000000046 ONDCP-18-0107-A-000019 46. The Comm ission recommends that HHS implement 6ruidelines and reimbur sement policies fo r Recove ry Support Services , includin g peer-to-peer programs, jobs and life ski lls training, supportive housing, and recovery housing. 47. The Commi ss ion re commend s that HHS , the Substance Abuse and Mental Health Services Admini stration (SAM HSA), and the Administration on Children, Youth and Families (ACYF) should dissemin ate best pra ctices for state s regarding interventio ns and strategies to keep fa milies together , when it can be done safe ly (e.g., using a relative for kinship care). These practices should include utilizin g comprehensive family cent ered approaches and should ensure familie s have access to drug screening, substa nce use treatment , and par enta l support . Fu,th er, federa l agencies should research promising models for pregnant ru1dpost-partum wom en with SUDs and their newborns , including scree nings, treatm ent interventions , supporti ve hous ing, non-phann acologic intervention s for children born with neonatal abstin ence syndrom e, medicati on-assis ted treatment (MAT) and othe r recovery supports. 48. The Commi ssion recommends ONDCP , the Substance Abuse and Men tal Health Services Administration (SAMHSA ), and the Dep artment of Education (DOE) identify success ful college recovery programs , including "sober hous ing" on college cam puses, and provide suppo rt and technical assistance to inc rease the number and capacity of hig h-quality programs to help students in recove ry. 49. The Co mmission recommends that ONDCP , federa l partners , includin g DOL , large employers, employee assistance programs, and recovery support organiz ations develop best practices on SUDs and the work place. Employers need information fo r addressing employee alcohol and drug use , ensure that employees are able to seek help for SUDs through employee assistance programs or other means, supportin g health and wellness , including SUD recovery , for employees, and hirin g thos e in recovery. 50. The Commiss ion recommends that ONDCP work with the DO.I, DOL , the Nationa l Alliance for Model State Drug Laws, the Nationa l Conference of State Legislatllres , and other stake holders to develop model state legis lation/reg ulation for states to decoup le felony convictions and eligibility for business /occupational Licenses, where appr opriate. 51. The Comm ission recommends that OND CP , federal age ncies , the Natio nal Alliance for Recovery Residents (NARR ), the National Association of State Alcohol and Drug Abuse Directors (NASA DAD ), and h ous ing stakeholders should work collaborat ively to develop quali ty stand ards and best practices for recovery residences , including model state and local policies. These pa1tners should identify bani ers (such as zoning restrictio ns and discriminati on agains t MAT patients) and deve lop strategies to address these issues. Research and Development 52. The Co mmission recommends fede ral agencies, includin g HHS (Nat ional Institutes of Health, CDC , CMS , FDA, and the Substance Abuse and Menta l Health Services Admini stration), DO.I, the Depart ment of Defense (DOD) , the VA, and ONDCP, should engage in a comprehens ive review of exist ing researc h programs and establi sh goa ls for pain management and addic tion research (bot h preven tion and treatment) . JAPGl ON DCP006FY 18004 _ 0000000 46 ONDCP-18-0107-A-000020 53. The Commission recommends Cong ress and the Federal Government provide additional resources to the Nationa l Institute on Drug Abuse (NIDA), the National Institute of Mental Health (NIMH), and Nationa l fnstitute on Alcohol Abuse and Alcoholism (NIAAA) to fund the research areas cited above. NI DA should continue researc h in concert with the pharmaceutical industry to develop and test innovative medications for SUDs and OUDs, including long-acting injectables, more potent opioid antagonists to reverse overdose , drugs used for detoxification, and opioid vaccines. 54. The Commission recommends further researc h of Technology-As sisted Mon itoring and Treatment for high-risk patient s and SUD patient s. CMS, FDA, and the United States Preventative Services Task Force ( USPSTF) should implement a fast-track review process for any new evidence-ba sed technology supporting SUD prevention and treatment s. 55. The Com mission recommend s that commercial insurers and CMS fast-track creation of Healthcare Common Procedure Coding System (1-fCPCS) codes for FDA-approved technology-based treatments , digital interventions , and biomarker-based intervent ions. NTH shou ld develop a means to evaluate behavior modification apps for effectiveness. 56. The Commission recommends that the FDA establish guidelines for post-market surveillance related to diversion , addiction , and other adverse consequen ces of contro lled substances. IAPGl ON DCP006FY 18004 _ 000000046 ONDCP-18-0107-A-000021 The Drug Add ict io n and Opio id Crisis The primary goal of the President ' s Commission on Combatting Dru g Addiction and the Opioid Crisis is to develo p an effect ive set of recommendations for the President to combat the opioid crisis and dm g addiction in our nation. Many of the recommendations that follow will require appropriations from Congress into the Public Health Emergency Fund , for block grants to states and to DOJ for enforcement and judi cial improvements. It is not the Commission ' s charge to quantify the amount of these resoUJces, so we do not do so in this report. The Comm ission urges Congress to respond to the President' s declarat ion of a Pub lic Health Emergency and fulfill their constitutionally delegated duty and appropriate sufficient funds to implement the Commiss ion's recommendations. 175 Amer icans are dying every day. Congress must act. Notwit hstand ing this core mission, it is vital to address the influences that transformed the United States into the world leader of op ioid prescribing , opioid addiction , and opioid overdose deaths . Origins of the Current Crisis The Current Crisis. 1n the mid- to late- 19th century , the first national opioid crisis occurred; a detailed history is provided in Appendix 2. During this time, op ioid use rose dramatica lly, fueled by physicians' unrestrained opioid prescr iptions (morphine , laudanum, pare gor ic, codeine, and heroin) for pain or other ailments, and by liberal use of op ioid-based t reatment s for injuries and diseases impacting Civil War comba tants and vetera ns (see Appendix 2). In parallel with the current crisis, this nation-wide ctis is extended across socio -econo mic statuses, and reached urban and rural areas. This first epidemic was event ually contained and reversed by p hysic ians, pharmacists, medical education , and voluntary restraint , comb ined with federal regulations and law enforcement. After the first crisis subsided, medical educatio n empha sized the hazards of improper op ioid prescribing , and by doing so, created a cultural mindset against the dangers of op ioids. However , over 30 years ago, a sequence of events eroded fears of opioids, and the med ical community once again relapsed into liberal use of medicinal opioi ds. Triggered by excess ive prescribing of op ioids since I999, the curren t crisis is being fue led by severa l factors that did not exist in the 19th century: the advent of large sca le production and distrib ution of pure, potent , orall y effec tive and addiGtive opioids; the wides pread availability of inexpensive and purer iJlicit heroin ; the influx of highly potent fentany l/fentanyl analogs; the h·ansition of prescription opioid misusers into use of heroin and fentanyl ; and the production of illicit opioid pills containing deadly fentanyl(s) made by authentic pill presses. Prescription opio ids now affect a wide age range , fami lies both well-off and financially disadvantaged , urban and rural , and all ethnic and racial groups. Historical preceden t demonstrated that this crisis can be fo ught with effective medical education, voluntary or invo luntary changes in prescribing practices , and a strong regulatory and enforcement env ironment. The recomme ndations of the Commiss ion are grou nded in this reality, and benefit from modern systematic epidemiological and large data analytics , evide nce-based treatments, and medications to assist in recovery or rescue of an overdose crisis. JAPGl ON DCP006FY 18004 _ 000000046 ONDCP-18-0107-A-000022 Contributo rs to the Current Crisis. A wide ly held and supportable view is that the modern opioid crisis originated within the healthcare syste m and have been influenced by several factors: • Unsubst antiat ed claims: One early catalyst can be traced to a single letter to the Editor of the New England Journal of Medici ne pub lished in 1980, that was then cited by over 600 subsequent articles. 1·2 With the headlin e "Addjction Rare in Patients Tr eated with Narcotics ," the flawed conclusion of the five-sentence letter was based on scrutin y of records of hospitalized patients administered an opio id. It offered no information on opioi d dose, number of doses, the duration of opioid treatment, whether opioids were consu med after ho spita l discharge , or long -term follow-up, nor a description of criter ia used to designate opioid addiction. Six years later , another problematic study conc luded that "opio id maintenan ce therapy can be a safe, salutary and more humane alternative to the options of surgery or no treatment in those patients wit h intractable non-mali gnant pain and no history of drug abuse_"3 High quality evidence demonstratin g that op ioids can be used safely for chronic non-termina l pain did not exist at that time. The se reports eroded the historical evidence (see Appen dix 2) of iatrogenic add iction and aversion to opio ids, with the poor-quality evidence that was unfortunately accepted by federal agencies and other oversjgbt organizat ions. • Pain patjent advocacy: Advocacy for pain management and/or the use of opioids 4·5•6 by pain patients was promoted , not only by patients , but also by some physicians. One notable phys ician stated: "make pain 'v isible' ... ens ure patients a pla ce in the communications loop ... assess patient satisfaction; and work with narcotic s conn-ol authorities to encourage therapeutic opiate use __. therapeutic use of opiate analgesics rarel y resuJts in addiction_" 7 • The opioid phar mace utica l manuf actu rfog and suppl y chain indu stry: One pham1aceut-ical company sponsored over 20,000 educat ional events for physicians and others on managing pain with opioids , c.laiming their potential for addktion was low. 8 Yet, warning signs of the addictive poten tial of oxycodone and simjlar opio ids long predated this period: in 1963, Bloomquist wrote that dihydrnhydrox yco deinone (oxyc odone , Percodan ®), "althou gh a useful analgesic retains addjction potential comparable to that of morphine. This fact should be conside red when it is prescribed . Because of increasing numbers of addicts to this drng in the State of California, the Ca lifornia Medical Association Commjttee on Dange rous Dru gs and the House of Delegates bas recommended that oxycodone-containing drugs be returned to the triplicate pres cription list as the y were origina lly in 1949.'' This recommehdation failed to pass the legislatme. 9 Similar warnings followed. Aggre ssive promotion of an oxycodo ne brand from I 997-2002 led to a l 0-fold rise in prescriptions to treat moderate to severe noncanc er pain , and increases in prescribing of other opioids. Subsequent ly, the highe st strength s pem1issible was increa sed for opioid-tolerant patients , likely contributi ng to its misuse . Extended -release (ER) formu lations and dela yed absorpt ion were marketed as reducing abuse liability , but crushing the piJls allowed users to sn011 or inject the drugs . 10,11 There are now at least five marketed opioids that carry abu sedeterrent labelin g. It has been hypothesized that the marked rise in heroin and other illicit synthetic opioids is, in part , associated with unintended consequences of reformulation of OxyContjn , and a reduced supply and greater expense of prescription op ioids. 12• 13 To this day , the op ioid pharmaceutical industry influences the nation 's response to the cris is. 14 For examp le, during the comment phase of the gujdeline developed by the Centers for Disease Control and Prevention (CDC) for pain management , opposition to the guidel ine was more JAPGl ON DCP006FY 18004_ 000000046 ONDCP-18-0107-A-000023 common among organizations with funding from opioid manufacturers than those without fw1djug from the life sciences industry. 15 • Rogue pharmacies aod unethical physician prescribing: The key contrjbutors of the large number of diverted opioids were unrestrained distributors, rogue phannacies , unethical physicians , and patients whose opioid medications were diverted , or other patients who sold and profited from legitimately prescribed opioids. 16 • Pain as the 'fifth vital sign': The phrase , "pain as the ' fifth vital sign,"' was initially promoted by the American Pain Society in J 995, to elevate awareness of pain treatment among healthcare professionals ; "Vital Signs are taken seriously. If pain were assessed with the same zeal as other vital signs are , it wou ld have a much better chance of being treated properly. We need to train doctors and nurses to treat pain as a vital sign . Quality care means that pain is measured and treated. " 17 The Veteran 's Administration (VA) 18 and then the Joint Comm ission on Accre ditation of Healthcare Organizations (the Joint Commission.) designated pain as a ' fifth vital sig,1.' 19·20 The Joint Commission accredits and certifies hea lth care organizations. Certification has implications for objective assessment of clinical excellence , and for contracting and reimbtu-sement. The Joint Commission 's standards for pain assessment in 2000 ''were a bold attempt to address widespread underassessmen.t and undertreatmen t of pain,"21 even though the health care community was not advocating for a regulatory approach to pain management. 22 The standards raised concerns that requiring all patients to be screened for the presence of pain and raising pain treatment to patients ' rights issue could lead to overre liance on opioids. The Joint Commission received sponsorship for developing educational materials from an opio id phannaceutical company, one of over 20,000 pain-re lated educational programs through direct sponsorsh ip or financia l grants. It was "unaware that the science behind their claims and the advice of experts in the field were enoneous. " 2·1 This designation set in motion a growing compulsion to detect and treat pain , especially to prescribe opioids beyond traditional botmdaries of treating acute , postoperative , procedttral pain and end-of-ljfe care . The surge in opioid supply escala ted into opioid-related misuse , diversion., use disorder , and overdose deaths. Administrators , regulatory bodies , and insmers collectively pressmed physicians to address patient satisfaction with aggress ive pain management. 24 However, the concept that iatrogenic addiction was rare and that long-acting opioids were less addictive had been widely repeated , and studies refuting these claims were not published until years later. The Joint Commission has since eliminated the requirernent that pajn be assessed jn all patients , except for patients receiv ing behaviora l health care and established much stricter processes to review any corporate sponsorship of educational program s. In 2016 , the Joint Commiss ion began to revise its pain standards,2 5 which will go into effect in. January 20 18. • Inadequate oversight by the Food and Drug Administration (FDA): The FDA is the sole federaJ authority responsible for protecting public health by assuring the safety , efficacy , ru1d secu rity of human drugs , biological products , ru1dmedical devices. Ttapproves medications to diagnose , treat , and mitigate illnesses , after assessing their safety and efficacy. rt safegua rds the nation ' s medications by setting standards for proper prescribing of approved drugs and post-approval surveillru1ce. The FDA provided inadequate regulatory oversight. Even when overdose deaths mounted and when evidence for safe use in chronic care was substantially lackmg , prior to 2001 , the FDA accepted claims that newly fomm lated opioids were not IAPGl ON DCP006FY 18004 _ 000000046 ONDCP-18-0107-A-000024 addi ctive, d id not impose clinical trial s of sufficient durati on to detec t add iction, or rigorous post-appro val surveillan ce of adverse events, such as addi ctio n. Th e FDA also fai led to assess th e risks assoc iated with deliberate cliversion and mi suse of opioids, ris ks that conceiv ably outwei ghed the intended benefit s for patients ifu sed as directe d. They accepted the pharma ceuti cal indu stry ' s claim that iatro genic adcliction was "very rar e'' and that the delayed absorption of OxyCo ntin reduced the abuse liabili ty of the dru g.26 By 2001 , the FDA removed these unsubstanti ated clai ms fro m OxyCo ntin 's labeling. In March 2016, the FD A requeste d from the National Ac ademi es of Scienc es, Enginee ring, and Me clicine (N AS EM) and receive d on Jul y l 3, 20 17, a sum mary of the current statq s of sc ience regardin g prescri pti on opioid abu se and misuse, and th e role of opioids in pain man age ment. 27 The curr ent FDA Co m.missioner bas stated a stron g commitm ent to using the regu latory authorit y of the FDA to miti gate the adverse consequ ences of opioid use. 28 • Reimbur sement for presc ription opioids by hea lth care insurers : Sales of prescrip tion opioids in the U.S. nearly quadrupled from 1999 to 2014 ,29 largely paid for by insmance carriers . It is estimated that I out of 5 pat ients w ith non-cancer pain or pa in-related dia gnoses are prescribed opioids in office -based settings. 3 From 2007 to 2012 , the rate of opioid prescribing steadily increa sed amongst speciali sts more likely to mana ge acute and chronic pain(pain medicine [49 %], surger y [37%], physical medicine /rehabilitation [36%])_ Insuran ce carriers , including Medicare Part D plans , clid not serve as a stop-gap to the huge influx of opioid prescri ptions. ° • Medical education : Me dica l education has been defic ient in pain mana gem ent, opioid pr esc ribi ng, screenin g for, and treating addi ctions.3 1 Durin g the 1990's, the pain m ovement shou ld have alerted medical education institutio ns and creator s of continuin g medi cal education cour ses to addr ess this issue. lo some medica l schools and some spe cialties, it remain s inadequate to thi s day. 32 One strategy prom oted 10 ye ars ago to stratify patients ' ri sk for opioid misu se and overdo se w as the screenin g of patients for substanc e use disord ers (SU Ds), espec ially pain p atients.33 fmplementati on of Screening, Brief int erventions, and Referral to Treatm ent (SBIRT ) in health care sys tem s w as iace ntivize d with billin g codes. 34 SBIRT was main streamed int o health care reform , but has yet to be in corporated nationally into medical curricula, or appli ed as routin e care. No r do core curr icula necessarily addr ess addic tions, treatment opti ons, or stress the need to screen for substan ce use and mental hea lth.. • Lack of pati ent education : Patients and thei r famili es are not often foll y inform ed regarding whether their prescripti ons are opioids, the risks of opioid add iction or overd ose, contr ol and diversion, dos e esc alat ion, or use with alcohol or benzodiazep ines . • Publi c dem and evolves into reimbur sement and physician quality ratings pegge d to patient satisfaction scores: Today, the use of opioids for chroni c non-cance r pain rem ains controversial for the same reaso ns their use dec lined and was avoided at the tum of th e 20lh ce ntury : the potential for mjsuse and adcliction, insuffici ent high-qu ality evidence of efficacy with long-term use, poor functional oqtcomes, overd ose and death . Yet, a stron g publi c demand for opioids con tin ues to pre ssur e clinicians to presc ribe opioids persists. As an exa mp le, a rece nt sur vey of Emer gency Depar tm ent (ED) phys icians indicated that 7 1% report ed a perce ive d pressur e to prescrib e opioid ana lges ics to avoid admini strative and regu latory cr iti cism_ Uniformly, th ey voiced concern about excess ive emph as is on pat ient satisfaction sco res by reimbur sement entities as a means of eva luating their patient [APGl ON DCP006FY 18004 _ 0000000 46 ONDCP-18-0107-A-000025 management. The physician requirement to address pain as the "fifth vital sign" persist s,35 and reimbmsement metrics based on patient satisfaction may have inadvertently created an environ ment cond ucive to exploitation by prescription opioid abusers. 36 There are legitimate circumstances for wh ich opioids are an appropriate therapy. But many current institutional and soc ietal -issues continue to pressure physicians to prescribe opioids when they are not clinicall y appropriate . Prior to this year , poor patient satisfaction with pain care could lead to reduced hospital reimbmsement by Medicare through Value-Based Purchasing (VBP). There are often higher costs or no specjfic reimbursements for alternative pain mana gement strategies, alternative pain intervent ion strategies , or spending time to educate patients about the risks of opioids. Further , failin g to provide adequate pain re lief can be gro und s for malpractice claims or medical board action. • Lack of foresight of unintended consequences: As prescription drug s came under tig hter scrutiny and access became more limited (via abuse-deterrent formulations and more caut ious prescribing) , market forces responded by providing less expe11sive and more accessib le illicit opioids. Increases in ove rdose death number s due to prescription opioids have transitioned to overdoses large ly due to heroin and., increasingly , fentanyl.3 7 Locally , this tJend may have been driven , in part , by tighten ing contro ls on prescription opioids. Physicians curtail ed op.ioid prescriptions without guidelines on tapering and without determination of whe ther patients had deve loped an opioid use disorder (OUD) , and if so, how to respond .-18 The availabi lity of cheaper heroi n also drove prescription opioid misusers to illicit opioids. Black market heroin is currently much less expensive than diverted prescription opioids , and fentanyl is even much less expens ive per dose than heroin . Predictable from the economics of the two drug categories, the prescription drug overdose problem has decreased, but not the overa ll number of opioid-related deaths. • Treatment services insufficient to meet demand and to provide medication-assisted treatment (MAT): As OUD s increased dramatically over the past 15 years , quality treatment services and the associated workforce did not expand in response to the growing crisis. • Lack of national prevention strategies: Prevention sn·ategies focusing on specific illicit drugs for vulnerable populations - adolescents , college age youth , pregnant women , unemployed men, and othe r - and for influencer s, (parent s, fam ilies) don't ex ist or have not been tested adequately. Magnitude and Demographics Natio,wl statistics 011 prescription opioid mis11se,md use disord er, 2016. 39 Weighted National Survey 011 Drug Use and Health (NSDUH) esti mates sugges ted that, iJ12016, 91.8 million (34. 1%) or more than one-third of U.S. civilian , noninstitutionalized adult s used prescription opioids ; 11.5 million (4.3%) misused them. In 2015 , 1.6 million (0.7%) had an OUD . Among adu lts with prescription opioid use, 12.2% reported misuse and 15.1% of misusers reported a prescription OUD. 40 The most commonly reported motiv ation for misuse was to relieve physical pain (63.6%). Misuse and use disorders were most commo nly reported in adults who were uninsured , were lAPGl ON DCP006FY 18004 _ 000000046 ONDCP-18-0107-A-000026 unemploye d, had low income, or had behav ioral healt h problems. Among adults with misuse, 62.2% reported using opio ids without a prescription , and 40.6% obtained prescription opioids for free from friends or relatives for their most recent episode of misuse . The results suggest a need to improve access to evidence-based pa in management and to decrease excessive prescribing that may leave unused opioi ds available for potential misuse.41 The NSDUH estimates that 3.4 miUion peop le aged L2 or older in 20 L6were current misusers of pain relievers (1.2% of the population aged 12 oi- older) .42 In 2016, an estimated 239,000 adolescents aged 12 to 17 were current misusers of pain relieve rs ( 1.0% of adolescents ) and 631 ,000 young adults aged 18 to 25 misused pain relievers in the past month (1.8% of young adults). Among adu lts aged 26 or o lder, 2.5 million are estima ted to be current mis users of pain rel iever (1.2%) . Upwards of 1.8 million Americans harbor an OUD invo lving prescription opioids or 0.7% of people aged 12 or older. Among adolescents aged 12 to 17, 152,000 (0.6%) had a pain reliever use disorder in tb.e past year, and 29 1,000 young adults aged 18 to 25 (0.8%) and 1.3 mil lion adults aged 26 or older in 2016 (0.6%) had a pain reliever use disorder in the past year. The se sma ll percentages do not convey the massive personal and public hea lth burden created by misu se of opioid s. Nati01wlstatistics 011 heroin use and 11se 1/isorder, 2016.43 The addictive and illegal opioid heroin has no accepted medical use in the United States. Past 30 day users of heroin (475 ,000) among people aged 12 or older or 0.2% of the population is probably an underestimate because NS DUH surveys househo lds and does not captur e heroin users in homeless shelters or transient populations with no fixed address , and the incarcerated. Despite its dangers heroin use continues to escalate and reflects change-s in heroin use by adu lts aged 26 or older and , to a lesse r extent , among yow1g adults aged 18 to 25. Less than O.l % of adolescents aged 12 to I 7 were current or past year heroin user s (3,000 and 13,000, respectively) and these numbers remained relative ly stab le. Among yo w1g adults aged 18 to 25 , 0-3% were current heroin users (88,000 ) and this numb er rose since 2002. For past year and at minimum , 630,000 individuals have a heroin use disor der (HUD ).17 Among adults 26 and older 0.2% were current heroin users (383 ,000) , a rise since 20 15. About 626 ,000 people aged l 2 or older r eporte d an HUD (0.2%), an increase since 2002 to 2011. Less than 0.1% of adolescents aged 12 to 17 (I ,000) had an HUD in the past year , but this rate was many times higher among 18-25-year -olds (152 ,000 ; 0.4%). Approxima tely 473 ,000 adults aged 26 or older had an HUD (0.2%) Substance use anit>t!onll,t!ol O'JU'ldes ~substanc e MM!se tre.-mertf~ ■ LJ,geCA!f!tr~ I MecroC7) ■L1r,:t frl'IC•MfuolB8) ■M.dlllm MelnlCtOOt [] s-.111.1..- 1100) ■Mtcrooo1,on(1S1l a NOnOn1n 1, 1-- O co1.m~widif~(l ."1 Figure l. Countieswith No Treatment Facilitiesfor SubstanceUse Disorder by Level ofUrbanizatioo Furthermore , 85% of all U.S. counties have no OTPs that provide MAT for people diagnosed wi th an OUD (Table l ) . These facilities are concen trated in large central metropol itan areas, where 88% of tliese count ies have at least one treatment facility offer ing OTP ( only 12% of these centra l metropolitan counties do not have OTP facilities ). For other metropolitan counties , 65 to 75% do not have OTP facilities , but among rural countie s, almost all (91 to 99%) lack an OTP facil ity. [APG] ONDCP006FY18004_000000046 ONDCP-18-0107-A-000036 Figure 2 shows counties that did aot have an OTP facility as of Janua ry 2016 ; as w ith SUD treatment facilities gene rally , the vast majority of these are rural counties. Many large fringe and medium metropolitan counties appear as doughnut-shaped areas around core locations wbere OTP facilities are located, but many rural counties are located far from OTP facilities. Data were also obtained on the locations of ph ysicians that can dispense bupreuorphine from their offices. 122 Physicians can pro vide MAT for OUD treatment u.1settings other than OTP facilities , including dispensin g buprenorphine from their offices. To prescribe or dispense buprenorpbfae for OUD treatment , qualified physicians must receive waivers from the DEA under the terms of the Drug Addiction li-ea/ment Act of 2000 (DA TA 2000). As of February 2016 , 47% of counties nat ionwide did not have a waived physician (Table 2). However , when classifying the county location s of waived ph ysicians according to level of urban ization , the rural-urban disparities become clear. None of the large central metro counties, and 72% of the most rural counties , did not have a waived physician (Figure 3). The vast majority of counties without buprenorpb.inewaived doctors are rural. However , it is worth noting that the number of patients a physician can treat with buprenorphine is capped; so, hav ing a waived phys ician within a geogra phic area is not necessaril y indicative of sufficient access for county or city residents. Orlwntu bon le'ff!tof ( OUt+UHlatfl'Jnaoprol d tre.Mm.tntf ~i htits a 1.1,p:c-tr1~ Mtv ol l ) • Lll1tF11n 1e M«,otl.59) • ~um M"tn (lU } 0 Smat~U6ll - Misttnt Abstlnonce '':r~~M IBiH1f H:fri:§I f;Uf ·H[ ·HIM effective and cost-effective policies for RetOWfy addressing substance use and disorders in RISK ~~S bviro,1meftt our nation. A systems app roach can lndMdu~I Orues facilitate development ofrecom ruendations PREVINTION and solutions to this dynamic and ever lnitht ion shifting challenge . This report addresses solt1tions to eacb of the core components of the crisis, a trajectory which begins with drug supply , att itude s towards drug use and -......;~sertnaM•d,.,,Pno knowledge of opioids, ri sk factors for misusing , and progress es to addiction , h·ans,bon to heroin/fentanyl , situational factors in overdose , rescue , treatment , relapse pre vention , recovery Figure 4. Opioid Crisis-Intervention Stages support , and continuum of care lFigure 4). Over the past decade , large databases bave accumulated to inform policies and associate d budget s. . The most ttrgent goals and readily quantifiable achievernents will be a reduction in overd ose episodes and deaths , increased entry into and adherence to high quality treatment , and a reduct ion in presc ribed op ioids. More complex model s are needed to addres s whether prescribing policies result in time-dependent reductions in prescription opioid diversion or increase heroin /fentan yl use , who is at risk for transitioning to heroin or fentanyl, the incidence and p reva lence of OUD , and others. Th e opioid epidemic defie s standard medical and legal mod els for addressing add iction and trafficking. Limited data exists to track the crisis and identify weaknesses in current responses (e.g. presc ribing practices, treatment avajlability , individuals at risk), but is held in different databa ses acro ss a multitude of pub lic and pri vate organizations, and significant propor6on is not in real-time . Building a secw·e data foundat ion that promotes cross -ent ity collaborat ion while protectin g pr ivacy is a cballengiog but necessary step to save lives, expand treatment options , and effectively preve nt further spread of thi s dead ly epidemic. The data exists but resides in agency silos , or in the private secto r providi ng ana lytics for specific industries (e.g. pharmaceutical or healthcare insure rs). making it difficult to act upon the info rmation. The Federal Government should create an integrat ed data environment that brings together publicly available data with agencyspecific data to help address this epidemic. Often , the same data viewed tlu·ough a different lens can sup port multiple part s of the problem. For exa mple , doctors ca n use prescription drug monitoring programs (PDMPs) to check patient records , while law enforcement can usePDMP s to iden tify prolific opioid pres cribers and publi c health agencies can use it to identify and intervene in a potential victi m pool before overdoses occur- differen t, but all valu able uses of the same data . This kind of effor t would not req uire a new data warehouse or standardiz ation initia live; the integrated data environment can immediate ly integrat e existing data sources. IAPGl ONDCP006FY18004_000000046 ONDCP-18-0107-A-000039 Federal Funding and Programs On page 87 of the report , there is a full breakdown of federal fonding sources for drug-related activities , including interdiction . prevention, and treatment. As shown in that sect ion, the federal fundjng landscape is complex. exists in silos, potentially duplicative , and suppo 1ts hundreds of on the ground programs. Streamlining Federal Funding for Opioids and Consideration of State Administrators One of the first activities the Commission Chair w1dertook was a series of calls with Governors ' Offices in nearly all 50 states. A number of themes ~merged from those calls that are reflected in this report and the recommendations . Regarding funding , man y Governors and senior staff member s expressed concern at how addiction and opioid-re lated funding coming from the Federal Government was fragmented ; provided by many different agencies and funding sources which each had their own application requ irements, reporting mechanisms, and prefened outcomes. It is clear that each federal agency has goals related to reducing drug use and misuse and provides funding for such activities . However , from the vantage points of states , this funding is not well coordinated , and applying for funding from the many differ ent agencies , is a tremendous administrative burden for states. The SAMHSA block grants provide a fonnula-based grant to states for treatment activities ; if additional fonding opportunities cou ld be rolled into the SAMHSA block grant, or comb ined to fonn larger block grants that required one application and one set of reporting requirements , that would free up state resources to focus on implementation activities, rather than paperwork_ Some states have identified a State Administrator to coordinat e opioid and addiction activities. Others may use their Single State Authorities for substance abuse services to serve as an effective point of contact or liaison regardi ng most federa lly-supported demand reduction efforts in a state-although they may not always have up-to-date informati on on Department of Health and Human Services (HHS) or Department of Justi ce (DOJ) discretionary grant activities not directly involving the state. Regardless of the single entity that is identified by the state, the Federal Government should have a comparabl e single entity point of contact to help track activities related to 1-rants with a demand reduction focus. discretionary 1:, The Office of Nat ional Drug Control Policy ' s (ONDCP ) core function is to develop and coordinate the implementation of national drug policy , but it does not have appropriate staff or organizational units to track federally supported demand reduction funding and activities at the program or 1:,trant level (versus the overarching policy level). The tasks of making and tracking grant awards fall squarely within the responsibility of the Departments and agencies that manage grant programs , including HHS 's Regional Offices and the more recently established Substance Abuse and Mental Health Services Administration (SAMHSA) Regional Directors stationed in these offices. lt therefore would seem reasonab le for HHS to suppor t ONDCP in this function by serving as an intermediary with Single State Authorities in the 50 states , the District of Columbia , and the territories. By so leveraging HH S and SAM HSA regiona l infrastructure , ONDCP could maintain timely accounting and ongoing awareness of the current allocation of federal demand reduction funding and the coordi nation of federally supported initiations , their contri bution to activities fAPGl ON DCP006FY 18004 _ 000000046 ONDCP-18-0107-A-000040 funded at the state and local level, duplication or inefficiencies tliat may need to be addressed , and timely scrutiny the program effect-iveness offederally-or-state-funded programs . This would assist 0 DCP to become aware of promising practices emerging at the state level. 1. The Commission urges Congress and the Administration to block grant federa l funding for opioid-related and SUD-related activities to the states, where tbe battle is happening every day. There are multiple federal agencies and multiple grants within those agencies that cause states a significant administrative burden from an application and reporting perspective. Creating uniform block grants would allow more resources to be spent on administering life-saving programs. This was a reque t to the Commission by nearly every Governor, regardless of party, across the country. 2. The Commission believes that O DCP must establish a coordinated system for tracking all federally-funded initiatives , through support from HHS and DOJ. lf we are to invest in combating this epidemic we must in est in only those programs that achieve quantifiable goals and metrics. We are operating blindly today; 0 DCP must establish a system of tracking and accountability. Funding Effective Opioid -Related Programs As stewards of taxpayer dollars, the Federal Government must ensure tbat programs demonstrate effectiveness in achieving the desired policy outcomes. While various assessments ha e demonstrated that treating and preventing ubstance use are effective in reducing the costs associated with health care, the workplace , and criminal justice system, these costs-benefit analyses were done at the system , not program , level. At the program level, the Federal Government has a long history of undertaking a variety of efforts, varyingly referred to as strategic planning , performance management program evaluation , or performance budgeting , to -inform mrurngement decisions for prob>ramand policy officials. These efforts have contributed to significant investments being made in the development of an evidence base for effective programs _ However , comparing the effectiveness of programs has proven more elusive, and looking at system-wide cost effectiveness is rare. Research studies in addition to private and public-sector analyses may be of value to Federal efforts to develop and implement cost-benefit evaluations . For example , the Washington State Institute for Public Policy maintains a list of available , evidence-based public policy options and ranks them by reh1m on investment. 125 While not a complete list, such ranked lists provide policymakers with a better understanding of the likelihood of which, of the many policy options a ailable , are most likely to produce more benefits at lower costs . Given the substantial challenges of the heroin and prescription opioid epidemic it is c1itically important that the Federal Government maximize the impact of its response by supporting the most effective programs and policies to reduce the number of individuals affected by OUDs and end the nation ' s opioid epidemjc_ A thorough review of programs and policy options would assist the Director of ONDCP in making recomme ndations on how to best allocate scarce federal resources to achieve the objectives of the Naliv11al Drug Control Strategy. IAPGl ONDCP006FY18004 _000000046 ONDCP-18-0107-A-000041 3. To achieve accountability in federal program the Commission recommends that 0 1'"'DCPreview is a component of every federal program and that necessary funding is provided for implementation. Cooperation by federal agencies and the states must be mandated. IAPGI ONDCP006FY18004 _000000046 ONDCP-18-0107-A-000042 Op ioid Addic t ion Prevention It is important to cons ider that the national crisis is not only about prescription or illicit opio ids. We are focusing on this class of substances , but prevention effot1s need to be broader because the removal of one substance conceivably will be replaced with another. To address the opioid and addict ion epidemic , it is vita l to make substance use and misuse prevention a much higher priority and stop the pipeline into addiction . In the first Commission meeting, General A rthw- Dean, speaking on behalf of Community Ant i-Dm g Coalitions of America, expressed the strong belief that prevention has been underutilized , relative to its importance and cost -effectiveness in preventing or reducing dmg use and misuse and the related human and societal costs. The American Society of Addiction Medicine (ASAM ) and the Addiction Policy Foru m both recomme nded the law1ch of a national public education campaign , similar to the one developed for the AIDS ep idemic in the I 980s , to ra ise awarene ss that addiction is not a moral failing , but rather a chronic brain disease , and that evidence-based treatme nt is avai lable. A generalized prevention campaign should address use of illicit drug s with abuse potential, as they can progress to addiction. Addiction is the most prevalent and costliest of neuropsychiatric disorders and the leading cause of prernatme , preventable deaths and disability in the United States. Of the ~2 million annual deaths in the United States, one-quarter are attr ibutable to the conseq uences of tobacco , alcohol, opioids , and other drugs . Dmgs impact every sector of society - individuals , families, communiti es, healthcare systems , educational environment , workplace , traffic safety , and the criminal ju stice system. Studies investigati.□ g the effects of drugs in the brain., body , and on behavior has yielded a vast base of information over the past twenty ye ars, relevant and indeed critical information for publ ic education. These research discoveries bave outsized power and potential to heighten awareness and promote prevention , but their impact bas been limited by discon tinuities in translating research into effective prevent ion mes sages and broadcasting them widely. The curr ent op ioid crisis dramatically illustrates an unfulfill ed need for expanded educational outreach to new generations of yo uth, their parents and the general population. Youth are more susceptib le to addiction and are a key target cohort for prevention . The vast majority of users fall into 16-34 age category, a peak period for pregnancy , parenting, and fm adverse consequences of drugs: addiction, underemployment , health issues, accidents , and trauma. It is well recognized that use rates are inversely corre lated with perception of risk, yet effect ive state-of-the-a1t, credible, compell ing, and comprehens ible informat ion on the risks and adverse health consequences of drugs has not been mounted to reverse these trends . The Nationa l Institute on Drug Abuse's (NIDA) Drug Facts Chat Day webs ite (http://drugfactsweek.drugabuse.go v/chat/) offers some insights into yotmg people's curiosity for accurate information about drugs and the lack of accessi bility to information. Teenagers fro01 around the nation are offere d a day- long session to ask NIDA staff their personal question about dn1gs. A sampl ing of questions is listed below : • • • • Wl1at is in drugs that make it so addict ive? What should you do if a parent is doing dmgs? Do drugs kill brain cells? Is drinking worse than smoking? IAPGl ON DCP006FY 18004 _ 000000046 ONDCP-18-0107-A-000043 During this nation 's worst dmg crisis, there is no more opportu ne time to launch a national prevention campaign that highlights the hazards of substance use, but also focuses on the opioid crisis: ( 1) to educate the publ ic on risks and consequences of drug use in general , with emphasis on opioids ; (2) to focus on the vulnerable - ado lescents , co llege age students , pregnant women, those harboring a psychiatric disorder , and the elderly - and highlight the deh·imental effects of opioids ; (3) to convey to parents their critical role in determining their children ' s use of drugs; (4) to show parents how to engage in crucial conversations with children about drugs; (5) to dispel common myths and misinformation on drngs ; (6) to educate families on warning signs in family members and on reducing environmental risks for children ; ( 7) to advance the concept of addiction as a treatable brain disease; and (8) to tailor messages to specific populations and communities in need. Many sources of information exist from government agencies (e.g. NlDA , SAMHSA , National Institute on Alcohol Abuse and Alcoholism [NIAM] , DEA) or on websites of non- and for-profit private organizations . The reach of these websites is limit ed, and their impact and va lue W1determined. Creative strategies are needed to engage much larger populations , with accountability on effectiveness. Notably , recent surveys indicate that parents can be key contributors to a child ' s use or non -use of drugs. Youth alcohol or marijuana use was 5-7-fold lower if parents took a strong stance against use , compared with parents whose views were ambjvalent. Systemat ic reviews have reinforced this conclusion .l26 · 127 Yet, parenta l know ledge is limited, as illustrated by examples from a recent survey: a) Nine of ten parents do not think that teens spending time on socia l networking sites like Facebook are likelier to drink or use drugs. Yet. teens who spend time on a soc ial networking site in a typical day are much likelier to use tobacco , alcohol , and other drugs than teens who don ' t spend time on a social networking site in a typical day; 128 b) When asked , ''do you consider it necessary to take steps to keep your ch ild from having access to prescriptions for painkillers such as Oxycontin , Vicodin or Percocet in your home? ," 57% of parents wit h prescription pain killers in their home did not consider it necessary to prevent their child from accessing the prescriptions , 129 even though more than 50% of people who misuse prescription pain killers obtained them for free from friends and family.130 Yet, the 20 16 national survey indicates that parental attitudes are critical in determining youth drug use. 131 c) One-third of parents surveyed reported that it was "very likely" or "somewhat likely" that their teen would "try drugs (including marijuana or prescription drugs without a prescription to get high) at some point in the future." Yet , if parents are perceived to disapprove of marijuana use, use among youth is approximately 9 times lower. 1.12 Parents have been under-represented in prevention programs , even though evidence is robust that parent-based prevention programs can play a pivotal role in delay ing the onset and use of alcohol and other drugs , an influence that persists during adolescent development. Furthermore , universal prevention programs are enhanced with inclusion of parent-based components. 1H In a systematic review of studies which combined studeut- and parent-based proe,,rarns to prevent or reduce adolescent alcohol , tobacco or marijuana use, effectiveness was shown in the majority of studies_ In summary , there is a compelling need to integrate ev idence-based prevention programs in large scale outreach programs within schools. With tools for teachers and parents to enhance youth knowledge of the dangers of drug use, early intervention strategies can be imp lemented for JAPGl ON DCP006FY 18004 _ 000000046 ONDCP-18-0107-A-000044 children with environmental and individual risk factors (trauma , foster care, adverse childhood experiences [ACEs] . and developmental disorders) . Evidence -based Prevention Program s Substance abuse prevention is a process which requires a shift in behavior , culture , and community norms . An investment in prevention requires meaningful outcome measures planned in coordination with the program. Demonstrated evidence of program effecti veness can include delaying the age of initiation of substance use, decreasin g the munber of new or cunent users, decreasing the frequen cy of use, reducing the adverse consequences of use (e.g. effec t on school grades , employmeht , and others) , decreasing use among contacts ,u 4 and dtiration of effect. When evidence-based program s are selected for specific population s and implement ed with fidelity . they can be effective _Prevention programs need to be tested for scalability , fidelity , and sustainability after research champions are no longer present to drive programs. Prevention is most succes sful when messages are consistent, cultura lly-appropriate , repeated at home , reinforced in schools . workplaces , and community organizations , and delivered by influentia l adtilts and peers . NASEM bas described three categories of prevention interventions : universal , selective , and i11dicated. These intervention s have been researched based on targeted populations and risk factors (e.g. schools , parents , or youth)_ Risk and protecti ve factors are influential at different times during development , and they relate to changes that occur over the course of development. Ri sk factors can interrupt developmental patterns and it is therefore important to implement programs designed for early developmental periods by building on the strengths of the child or caregiver. Intervening early in childhood can alter the life course trajectory in a positive direction .135 Below is a description of the three categories of prevention intervention s that target several risk factors and increase protecti ve factors: • Universal interventions attempt to reduce specific health problems across all people in a pa11icular popu lation by reduc ing a variety of risk factors and promoting a broad range of protecti ve factors. Examples of universal programs include : Good Behavior Game 136 o Nurse Family Partnership 137.JJ8 o Life Skills Training (LST) 139 o Strengthening Familie s Program 10-14 140 o Communities that Care 141 o • Selective interv entjou s are delivered to pa1ticu lar communities , families, or children who, due to their exposure to risk factors , are at increa sed risk of substance misuse problems. Selective intervention s may include families living in poverty , the children of depre ssed or substan ce using parents , and children who have difficulties with social skills or may have experienced trauma . Examples of selective programs include : o Coping Power 142 o Focus on Families 143 IAPGl ON DCP006FY 18004 _ 000000046 ONDCP-18-0107-A-000045 • Indicated inter ventions are directed to those who are already involved in a risk y behavior , such as substance misuse, or are beginning to have problems , but who have not yet developed an SUD . Examples of individual intervention programs include : o o o Project Toward No Drug Abuse BASICS Keepin ' it Real Schoo l programs implementing environmental approache s targeti ng children focus on building a repertoire of positive competencies , including in the areas of academics , self-regulation , and soc ial skills. Teachers can focus on interventions in the classroom for those who may need support with self-regulation and soc ial skills. ln creas ing the capacity of teachers by training them in classroom management strateg ies (e.g. establishing clear rules and rewards for compliance , teaching internctively , and promoting cooperative leami11g) provides them with the skills for managing behavior s and teaching children self-regulation. 144 Risk and protective factors can be influenced by the choice of programs and policie s at multiple levels, including federal , state, community , family, schoo l, and the individual. One advantage of a properly implemented universal prevention intervention is that it is likely to reach most or all the population (e.g. school-based intervention s are likely to reach all students). Targeted (selective and indicated) approaches provide more intensive services to those who are reached. It is prudent for communities to provide a mix of universal, selective , and indicated preventive inteiventio ns. 145 SBIRTas a School Prevention Strategy SBIRT is an evidence-based systematic method to screen for problematic use of all substances and, depending on a cumnlative score, follow up with a brief intervention or referral to specialty treatment. The service was catapu lted more wide ly into healthcare systems following a report from the Federal Government demonstra ting effectiveness in reducing substance use, 146 and the advent of billing codes to reimburse for these services. 147 Altho ugh traditionall y developed for clinical care, SBIRT services have been increasingly offered in high schoo ls and universities. School nurses and counselors are uniquely positioned to discu ss substance use among young people. In 20 I 6, Massachusetts passed a bill enabling appropr iately trained sta ff to reinforce prevention , screen for substru1ce use, provide counse ling and rnake referral s as necessary to aU adolescent s, including students in upper elementary grades. Ado lescent SBIRT focuses on prevention , early detection , risk assessment , brief counseling and referral intervention that can be utilized in the school setting. Use of a validated screening tool (CRAF FT) focused on adolescent s has enabled school nurses and counse lors to detect risk for substance use-related problems and to address them at an early stage in adolescents. The bill requires all public -schoo l districts in Massachusetts to screen seventh and I 0th graders for potential drug use, and is viewed as a way to interrupt the potential use of drugs , including opioids , at an ea.rly stage, The screenings do not involve drug tests, but rather a screener (school nurse or psychologist trained in conversations on drng use with youth) to determine through a conversatio n/ questionnaire if the student is engaged in risky substance use . Advertisement JAPGl ON DCP006FY 18004 _ 000000046 ONDCP-18-0107-A-000046 The intent is to identify students who need help and to try to motjvate them into treatmeut. Students or parents can opt out of the screening and parents are not immediately notified of the screening results to protect students' privacy. Parents are notified only in severe cases of adctiction. Previous research showed that 14.8% of adolescents had positive results on the CRAFFT screen. Prevalence rates differed s-ignificantly across practices after adjusting for demob,'rfaphicfactors. The highest positive rates on the CRAFFT screen were at school-based health centers (29 .5%) and the rural family practice (24.2% , the middle rate was at the adolescent clinic (16.6%) , and lowest rates were at the health maintenance organization (14 . 1%) and pediatric clinic 8.0%). Sick is its had the highest rate 23 .2%) . Well-child care visits had a significantly lower rate ( 11.4%). Statisrical modeling estimated that l l .3% of all patients had problematic use, 7. l % repotted abuse , and 3.2% bad an SUD. Substance abuse screening should occur whenever feasible , and not only at well-child care vis its. 148 Recently the State of ew Mexico has begun a program for universal screening , 149 the State of New York bas initiated SBIRT trials , 150 and calls for universal screening using va lidated SBIRT screening tools are increasing .151 Ohio State Univer sity developed an SBIRT course with the goa l of making SBJRT accessible for use on college and university campuses nationwide . To meet this goal , the Higher Education Center for Alcohol Drng Misuse Prevention and Reco ery developed ScreenU , a web-based program that allows SBIRT to be implemented with college students either independently or together with a campus professional. ScreenU identifies students who are misusing alcohol or prescription drugs and provides feedback and strategies to reduce their risk for experiencing negative consequences from their use. 4. The Commission recommends that Department of Education (DOE) collaborate with states on student assessment programs such as Screening, Brief Intervention and Referral to Treatment (SBIRT). SBIRT is a program that uses a screening tool by trained staff to identify at-risk )1outh who may need treatment. This shou ld be deplo_yed for adolescents in middle scbooJ, high school and college levels. Thi.s is a significant prevention tool. Mass Media Public Education Campaigns Mass-media campaigns are one of the primary universal prevention strategies for deliverin g educational messages on health promotion to youth and adults . A review of the literature provides an overview of the lessons learned from research on mass-media campaigns . The literahtrn is quite clear that mass media campaigns can increase awareness of messages but are not always successful in changing attitudes, beliefs or behaviors. 152 Mass-media campaigns tend to work best when they are well-targeted and supported by comprehensive community-based efforts that coordinate clinical , regulatory , economic , and soc ial strategies. Jn addition , funding for local prevention intervent ions that prevent initiation of a behavior and treatment programs that promote abstinence and reco ery are important. In addition to policies and strategies that help create environments that are less conducive to substance use, mass media campaigns can focus on either directly inf1uendng individual level predictors or influencing an individual s behavior through targeting others within youths social environment . Tbe forme sn·ategy looks to increase knowledge about a pruticular drug , its negative IAPGl ONDCP006FY18004 _000000046 ONDCP-18-0107-A-000047 health effects , self-efficacy in declining or stopping use, beliefs about the drug , and socia l norms about licit and illicit drug use. The latter includes mes sag es which discourage young people from pressuring friends to use .153 Regardles s of the approach , for a mass-media campaign to be effective , it is critical to develop coherent , credib le, evidence based-messages that are grounded in behavioral science .154This is critica l to counteract the meta-messaging that drug use in society is pervasive and normal. 155 Media messaging also must strategically targe t populat ions w ith culturally appropriate messages , take advantage of multiple media platforms , and have sufficient resources to pro vide broad exposure over a significant period of time to ensure an effect. Branding the campaign also has been shown to enhance the impact of public health messaging as has integrating a media literacy com ponent that help s train yo uth and young adults to critically view messages abou t substance use, be they with in televisio n shows, mo vies, or advertising . The literature is very lim ited on mass-media campaigns focusi ng on presciiption opioids , and even less on heroin and other op ioids. There is a more robust literatltre on lessons learn ed from massmedia prevention campaigns on alcohol and tobacco , which have been incorporated. OND CP' s earlier paid advertising campaign, the Natio11al Youth Anr;-Drug Media Campaign , targeted young people aged 9 to 18 years , their parents , and other influentia l adults. It used a combination of tele vision, radio ad vertisin g, other media, and communi ty programming with the goa ls to educate and enable youth to reject illegal drugs , prevent youth from initiating use of drn gs, especially marijuana and inhalants , and convince occas ional users of marijuana and other drug s to stop using. A comprehensive evaluation of the campaign 156 found substantjal evidence that the campaign favorably impacted parents on measures such as thinking about and talki ng with their children about drug s, doin g fun activities with thei r children , and beliefs abou t monitoring their chi ldren , but found little favorable direct effects of the campaign on youth. The evaluation found there were significant delayed unfa vorable effects of exposure to the campa ign on soc ial norms and perc eptions of use by youth ; greater expo sure was assoc iated with weaker anti -drug norms. Addit ionally, greater exposure may have led to higher rate s of initiation of marijuana use. Also, there was no evidence found to suggest that higher exposure to the campaign had any impact on quitting or reducing use. Governor Otter shared wit h the Commission Chair the successes of the Idaho Meth Prc?je ct, a large-sca le prevention program founded in 2005 wit h the aim to reduce metbamphetamine use through a comprehensive approa ch includi ng public services messages , public po licy approaches , communit y outreac h, and in-school lessons. The Meth Proje cl repo1is that 94% of teen s that are aware of t he anti-meth campa ign ads say they make them less likely to try or use meth, and that Idaho has experienced a 56% decline in teen meth use since the campaign began in 2007. In a pooled analysis of s-ites, including from Colorado , Georgia , Hawaii , Idaho , Montana and Wyomin g, no evidence was found of chan ge in past month use among subjects aged 12-17. 157 How eve r, there was evidence of reduction in past year use among this age grou p. 1n Idaho , this initiative was re-branded in 2016 as the Idah o Prevent ion Project to include opioids and prescription drug s. Anot l.ier study evaluated the impact of the SENsation seelcing T ARgetin g approach (Sn!VTA.R) focusing on anti-heroin public service announcements (PSAs) on proce ssing, affe ct, and antiheroin attitudes in a sample of 200 young adults. 158 Building on previous work ,159 this study recruited subjects from co mmtmi cations courses at a large Midwestern University exposing them to 30-second anti-h eroi n PSAs selected from a larger pool of PSAs produced by the Partnership [APGl ON DCP006FY 18004 _ 000000046 ONDCP-18-0107-A-000048 for a Drug Free America. lt utilized data from the 5-year television-based media campaign using public service annoW1cements targeting messages. They found that high-sensation seekers ' antiheroin attitudes were largely influenced by narrative and sensory processe s and low sensation seekers ' anti-heroin attitudes were relatively unaffected by anti-heroin ads. A national education campaign focused on opioids could be modelled after The Real Cost, an existing award-winning youth tobacco prevention campaign from the FDA . The Rea/ Casi seeks to educa te at-risk teens about the harmful effects of tobacco use with the goal of preventing youth who are open to using tobacco from trying it and reducing the number of youth who move from experimenting wit h tobacco to regular use. It was launched nationally in February 20J4 across multiple media platforms including TV , radio , print , web , socia l media , and out-of-home sites, like billboards. Initial campaign advertising focused on reaching the nearl y JO million youth ages 1217 in the United States who are either open to trying smok ing or are already expe rim enting with cigarettes. Results from the first evaluation published in 2015 indicated that 9 out of l 0 youth reported seeing The Real Cost ads seven month s after the campaign launch and that the campaign positively affected tobacco-related risk perceptions and belief s after 15 months. Further , from 2014-2016 , the campaign was associated wi th a 30% decrease in the risk of smoking initiation which translates into preventing an estimated 350,000 yout hs aged 11-18 from smoking. 1<>0 Media Campaign Focusing on Opio[ds A national prevention strategy with a comprehensive public health mass media campaign supported by evidence-based prevention programs is timely and essential. The goals would include: (a) universal drng prevention messages , as cun-ent or past SUDs predispose individuals to misusing opioids , and po lysubstance use disorder s are common ; (b) youth-directed messages , as they are more susceptible to addiction and other adverse consequences ; (c) prevention messages specific to opioids, to include patient and family education on what opioids a re, the hazards of opioids, safeguarding of prescription medications , and disposing of unused pills; (d) the common hazards of illicit and prescription opioids ; and (e) availab ility of treatment resources . Media campaigns are commonly used to deli ver preventive health messages and to shape healthy behaviors and attitudes. There are severa l succes sful state , local government and grassroots media campaigns aimed at provi ding drug-related public education or assistance in locating appropriate help for children. During the first Commission meeting on June 16, 2017, the Commission heard about one such campaign from the Partnership for Drug-Free Kids , who have worked with nationa l and local me-dia partners , as we ll as private sector partners like Google and Facebook , to run public service announce ments that inform parents on available help for their loved ones. Similarly , Commission Cha irman Governor Chr istie has implemented a media campaign in New Jersey around opioid addictio n and a help hotline and website . A comprehensive public health mass media campaign sho uld be conceived carefully , pilot tested on target audiences, quantitati ve goals estab lished , and outcomes measured that are matched to goals. Initially , accurate , anonymous, and actionable national data can be collected by probing the internet about the opioid crisis and, more broadly , you th attih1des towards drugs. Data analytical industries are capa ble of unco vering the extent , locations , spread , who are most affected by spec ific drugs being used, and how they are obtained by surveying the web in real-time with keywo rds . 161 These probes can also identify treatment barriers , including shame , stigma , mistrust , cost , service availability , service preference , treatment avoidance , perceptions of service quality , and denial of service. Probes and interactive dashboards can scientifically test th e potentia l success of pub lic fAPGl ON DCP006FY 18004 _ 000000046 ONDCP-18-0107-A-000049 health video and other multi-media messaging on anti-drug campaigns , and sl1ifts in sentiments , opinions , to provide continuous real-time survey data. Since use of specific drngs is initiated in different age ranges , the campaign would need to be shaped according to various demographics . For example , alcohol , tobacco , marijuana , and inhalant use begins, on average , in early adolescence; the use of cocaine , methamphetamine , and halludno gens in the later teen years; the misuse of prescription drugs (e.g., stimulants , tranquilizers , barbiturates , and pain relievers) and illicit opioids typically begins in early adulthood. There is an unmet need to launch a portfolio of comprehensible. compelling, and universal information to educate our nation on drug-related vulnerabilities of youth and other populations. Audiences would include teens, parents , people with psychiatric disoTders, older adults , and pregnant women . Informatio n would be created for television and for the internet, w ith a portfolio of animated , visual , interactive, narrated material , or videos , with minimal text, and pop-ups to counter misinfonnation on drug . This fonn of communicatio n has the advantage of fidelity , internctivity , feedback , and susta inability. 162 It can be dispersed on social .networking sites, accessible via computers , iPad, smartphones or smartwatches. The internet is rapidly evolving as the most important medium for teens , where teeo beliefs and perceptions are shaped, strengthe ned, and shared. Web-based digital , interactive, narrated , and animated materials should focus on: (a) the hazards of opioid use ; (b) the risks of adolescent drug use; (c) the risks of opio id use during pregnancy ; (d) the ctucial role of parents in protecting children; (e) counter commo n myths and misinformation on drugs ; and (f) educating youth and parents on signs of an emerging SUD. As menti oned above , parents can be major influencers on a child 's use or non-use of drugs , as drug use is considerably lower among youth if parents deliver strong, clear messages disapproving of drug use , are involved wi th their children's school work , set clear limits on children' s behavior by monitoring their time , friends , and superv ising activities , and communicate and connect effectively with their children. The media campaign ' s messaging willneed to be amplified and extended by the integrative effoits of evidence-based prevention programs at the local level, many of wh ich receive support from the Federal Government. To achieve the desired ultimate outcome - reduction in drug use - the campaign needs the support oflocally implemented evidence-based prevention programming. The campaign ' s messaging needs to be integrated closely with local effo1ts and amplified by them. Local partners could include community coalitions, such as ONDCP 's Drug-Free Community grantees , schools , hospitals , law enforcement , businesses , religious institution s, and local gover nment. ln this way, strong anti-drug abuse messages tightly focused on targeted audiences would serve to raise awareness of the problem and solut ions to it and improve anti-drug attitudes , beliefs and intentions , driving parents , adult influencers and yo uth to the loca l evidence-based prevent-ion resources available to achieve the desired behavioral outcomes. Although the funding level for the recommended campaign has not yet been determined, the initial ft.mding request in FY 1998 for the National Youth Anti-Dnig Media Campaign was $200 million per year. Those entities receiving campaign funds to air/print its messages were required to match the funds received, thus doubling the purchasing power of the federal funds. The Commission believes that a coordinat ed media campaigh that can be rolled out nationally witb a cons istent message about the dangers of both illicit and prescription drugs , jucluding opioids could effectively educate youth , parents , pregnant women . remove stigma associated with the disease of addiction , and reduce drng use and misuse . JAPGl ON DCP006FY 18004 _ 000000046 ONDCP-18-0107-A-000050 5. The Commission recommends the Administration fund and collaborate with private sector and non-profit partners to design and implement a wide-reaching, national multiplatform media campaign addressing the hazards of substance use the danger of opioids. and stigma. A similar mass media/educational campaign was launched during the AIDs public health crisis. Opio id Prescription Practices More than 20 years ago, a growing compulsion to detect and treat pain set in motion the prescribing of opioids beyond traditional boundaries of treating acute postoperative , and procedural pain and end~of-life care. The surge in opioid supply escalated into opioid-related misuse , diversion , use disorder, overdose deaths , and the advent of deadly fentanyl analogs. One of the areas which can have the greatest impact in the opioid crisis is reducing the rate of new addictions . This can be partly accomplished by aiming to prescribe opioids to appropriately indicated patients and that prescription durations and doses match the clinical reason for which the drug is prescribed . Some states have set firm limits on the maximum number of days of prescribed opioids at initial encounters , irrespective of pain condition . Im prov ing upon t he CDC Guidelinef or PrescribingOpioids for Provider/Prescr iber Educatio n ChronicPainand In March of 2016 , the CDC developed and published a guideline for prescribing opioid pain medications for adults 18 years of age and older in prima, }1 car e seltine,. . 163 This guideline is "intended to improve the communication between provider and patient about the risks and benefits of opioid therapy for chronic pain , improve treatment safety and effectiveness of pain treatment ; and reduce the risks associated with long-term opioid therapy , including OUD and overdose ." The guideline focuses on three key areas : 1 determining when to initiate or continue opioids for chronic pain ; 2) opioid se,lection, dosage , duration follow-up and discontinuation ; and 3) assessing risk and addressing harms of opioid use. Prescriptions by primary care clinicians account for neatly balf of all dispensed opioid prescriptio11s, and the growth in prescribing rates among these clinicians have been above average . More importantly , use of prescription opioids for more than 90 days increases the risk of progression towards addiction .164 A CDC "Morbidity and Mortality Weekly Report" published in Jttly 2017 found that while prescriptions for opioid medications ha e decreased since 2010 , substantial variation in opioid prescribing was observed at the county-level across the U.S., 165 demonstrating ''the need for better application of guidance and standards around opioid prescribing practices ." In the first Commission meeting , the Commjssion heard from variou s medical societies about the need to promote expanded implementation of the CDC opioid prescribing guideline. However while many professional organizations encourage use of the CDC guideline , it is important to note the Commission received a substantial amow1t of correspondence from patients who currently use opioid medications for legitimate medical reasons and are worried about the guideline being too restrictive for their physicians to properly treat them. Clinicians have added their concerns about the CDC guideline , including d1e time required to discuss alternative forms of pain control , the difficulty in obtaining reimbursement for alternatives , how to addres s opioid tapering , and [APGl ONDCP006FY18004 _000000046 ONDCP-18-0107-A-000051 concerns with the presc1ibing guide line for specific fonns of pain. Furthermore , it is important to point out that the CD C guidel ine is intended for primary care clinicians, who are treating patients for chronic pain in outpat ,ient setti11gs, and mor e latitude in decision making should be given to physicians th at have specia lized training in pain management. The Comm ission also recognizes that the CDC guideline may not include specific recommenda tions regarding patient education and informed conse nt. 166 Patients are ofte n ill-informed about the risks of taking opioid analges ics and, therefore , are not able to balance the potential benefi ts of opioid analgesics with the associated risks. While progress has been made in trainin g presccibers and foster ing the adoptio n of prescribing guidelines such as the CDC guide line, the Commission has learne d that not all states have adopted the guide line, not all physicians are aware of them , and sound opioi d presciibing guide lines are far from universally followed . For example , w hile the C DC guide line, as we ll as gu ideline s from the VA and the Department of Defense (DOD ), recommend clinicians use baseline and periodic urine testing as part of a co mpreh ensive plan to ensure the safe and effective use of opioid therapies , not all states have placed su ffici ent emphasis upon the utility of medication screenings. f n the current crisis , drug testing not only allows providers to assess proper use of prescribed medications in individual patients , but it woul d also be part of a broader so lution in fig hting the opioid crisis , as it can provide a snapsho t of contro lled prescription drugs and illic it drugs avai lable in a com munit y. Conseque ntly, the Com mission recommended in the interim report that medica l educa tion and prescriber educatio n initiatives in proper opioid prescribing and risks of developing an SUD be mandated (Appendix 3 ). Stakeholde rs important to the adoption of prescribing guide lines inc lude publi c and private payers , medical and dental schools, physician and pharm acy groups, insurers , and health care assoc iati ons . Medical associatio ns have developed cou rses for proper opio id presc ribin g practices , with support from federal grants and made them availab le onl ine for free. 167 · 168· 169· 17 Federal agencies have also compiled lists of courses in compliance with the CDC guide line . 11 1.m It is imperative that all DEA registrants prescribing scheduled drugs develop proficiency in. pain management and opioid prescribing. ln recognizing that OUD is associated with or preceded by other SUD s, training on diagnosis and office-base d treatment of addictions should a lso be implemented for all stages of professional activity , including medical school. residency , practicing clinicians , and all others legally permitted to prescribe scheduled drugs. ° Given that the practice of medicine , including prescribing , is regu lated primarily at the state level , strategies for ensuring that prescribers are better informed and that patients are ed ucated about the relative risks and benefits of opioid analgesics shou ld incorporate state governments . Many states have acted to improve the safety of opioid prescribing. In July 20 16, for examp le, 45 state governors signed the Compact to Fight Opioid Adcliction173 under which signatories agreed to update prescribing guidelines , require pain management continuing education for prescribers , improve monit01ing of providers prescribing opioids , and increase access to treatment and recovery supp ort services throu gh state healthcare programs. 174 In March 2016 , Massachusetts passed legislation 175 limiting opioid analgesic prescriptions to a seve n-day supp ly for first-rime adult users aud for min ors, mandating continn ing medical education (CME) cre dit s for effect ive pain management , and requiring prescribers to check the state POMP before wtiting a prescription for a Schedule II or Schedu le m narcotic _ IAPGl ON DCP006FY 18004 _ 0000000 46 ONDCP-18-0107-A-000052 Since January 2012, the State of Washington has required written treatment plans for use of opioid analgesics and a written agreement between patients and prescribers outlining patient responsibilities , includin g: taking the medications as prescribed ; pro viding biological samples for toxicology testing: releasing the agreement for treatment to local EDs, urgent care facilities, and pharmacies ; authorizing the prescriber to notify authorities if there is reason to believe the patient has engaged in illegal activit ies; and, acknowledging that it is the patient's responsibility to safeguard all medications and keep them in a secure locatioo.l 76 A recent survey in Massachusetts found that 50% of respondents felt that painkillers are prescribed too often or in larger doses than necessary ; 47% felt tbat getting painkillers from those who save them is too easy. Only 36% of respondents who had been prescribed an opio id were infomied of the addiction potential by their prescriber either before or while they were taking the medication . 177 In 2014, 4.4 million prescription s for Schedule II or Schedule IIl op ioids were written for Massachusetts residents , resulting in the dispensation of 240 milljoo pills or tablets. 178 Together , these data point to the need to explore prescriber and patient education as a component of any strategy to address the current opioid epidemic. A review of the curricula at the four medica l schools in Massaclrnsetts revealed that, although they taught components of addiction medicine , no unifonn standard existed to ensure that all sh 1dents were taoght prevention and management strategies for prescription drug misuse. To fill this gap, Commiss ion member Governor Baker and the Massachusetts Secretary of Health and Human Services invited the deans of the state's four medical schools to convene to develop a common educational strategy for teaching safe and effective opioid -prescr ibing practices. With leadership from the Department of Public Health and Massachusetts Medica l Society, the deans fom1ed the Medical Education Working Group in 20 I 5. This group reviewed the relevant literature and curre nt standards for treating SUDs and defined IO core competencies for the prevention and management of prescription drug misuse . The medical schools have incorporated these competencies into their curricula and have committed to assessing snidents ' competence in these areas . The members of the Medical Education Working Group have agreed to continue to work together on key next steps, including c01mecting these competencies to those for resident s, equipp ing .inter-professional teams to address prescription drug misuse , and developing material s in pain management and opio id misuse for practicing phy sicians. This first-in-the-nation partner ship has yielded cross-institutio nal competenc ies that aim to address a public health emerge ncy in real time. The following themes emerged from a literature review and from nationa l and local standards for treating SUDs. The core competencies are meant to enbance medical student training in primary , secondary , and tertiary prevention strategies for prescription drug misuse and to provide students with a strong foundation in prevention , identifying SUDs , and referring patients to appropria te treatment. These competencies are designed to serve as a vital bridge between undergraduate medical educatio n and residency training . I. Evaluate a patient 's pain using age , gender, and cultura lly appropriate evide nce-based metbodologies. 2. Eva luate a patient 's risk for SUDs by using a_ge, gender , and culturally appropria te evidence-based communication skills and assessment methodologi es, supplemented by relevant available patient information , including but not limited to health records , prescript ion dispensing records (e.g., the Prescript1on Drug Monitor111gProgram ), drug [APGl ON DCP006FY 18004 _ 000000046 ONDCP-18-0107-A-000053 t1rine screenings , and screenings for commonly co-occurri ng psychiatric (especially depression , anxiety disorders , and posttraumatic stress disorder). disorders 3. Identify and describe potential pharmacological and nonpharmacologica l treatment options , including opioid and nonopioid pharmacological treatments for acute and chronic pain management , aloug with patient communication and education regarding the risks and benefits associated with each of these availab le treatment options. • Secondary preven tion domain : Treating patients at risk for SUDs (engaging patients in safe , informed , and patient-centered treatment planning) 4. Describe SUD treatment options , including MAT , as well as demonstrate the ability to appropriately refer patients to addiction medicine specialists and treatment programs for both relapse prevention and co-occurring psychiatr ic disorders. 5_ Prepare evidence-based and patient-centered pain management and SUD treatment plans for patients with acute and chronic pain with special attention to safe prescribing and recognizing patients displaying signs of aberrant prescription use behaviors . 6. Demonstrate the foundational skills in patient-centered counse ling and behav ior change in the context of a patient encounter , consistent with evidence -based techniques . • Tertiary prevention domain: Managing SUDs as chronic diseases (eliminating stigma and building awareness of social determinants) 7. Recognize the risk factors for, and signs of , opioid overdose and demonstrate the con-ect use of naloxone rescue. 8. Recognize SUDs as a chronic disease by effectively applying a chronic disease model in the ongoing assessment and management of the patient. 9. Recognize their own and soc ietal stigmat ization and biases against individuals with SUDs and associated evidence-based MAT l 0. Identify and incorporate relevant data regarding social determinant s of health into treatment planning for SUDs. Int egrating the core competencies for the prevention and management of prescription dmg misuse with any related competencies forresidents is crWcaJ to ensuring that medical students are required to maintain and expand these skills as they enter residency training. Furthermo re, the group recognized the need to expand inter-professional education opportunities designed to better equip collaborative teams for primary , secondary , and tertiary prevention of OUDs. As other practitioners , including nurses. phannacists , dentists. and mental health providers , among others , also contribute to the provision ofcare , they too must demonstrate competence in this area . Fina lly, the group recognized the need for continuing medical education materials for current prescribers. The level of urgency is greater than ever to develop creative solutions based on exp loiting modem data mining and communi cation proficiencies. A more rational approach is to develop detailed and specific guidance for clinicians treating specific manifestations of pain. With modern data analytica l techniques capab le of interrogating vast prescribing databases, it is feasible to identify current patterns of opioid prescr ibing for specific conditions , recommend changes in practice patterns based on specific pain sources and medical specialties , and create active programs to educate practitioners on these recommendations . Combined wi th data from PDMPs , a simple electron ic printout conceivably can assist in guid ing a physician ' s decision on prescribing opioids or alternatives for pain management. Decisions on pain management can be fortified with lAPGl ON DCP006FY 18004 _ 000000046 ONDCP-18-0107-A-000054 additional infonnation on a patient ' s physical and mental health status , as the complex causes of pain can arise from a confluence of biological, psychological. and social factors. To advance this goal , providers need to be informed about suitable prescribing practices for opioids, a class of drugs which confer benefit , as well as high risk. Pharmacoepidemiology research can facilitate improvements to the CDC guideline by initially defining existing patterns of opioid use and then developing condition-speci fie guide\ ines on optimal opioid dosing .179·180 To create a more useful foundation for interventions to reduce improper use of prescription opioids , much more needs to be lrnown of existing patterns of prescription for specific conditions , including diagnosis , drng choice , dose amount prescribed , and physician and patient characteristics. This work would di:aw on the extensive experience of pharmacoepidemiological analysis , 18 1 as well as extensive population-based datasets from both the public and private sector. 182 These studies will help to define wh ich specific problems of opioid overn se are most prevalent in which settings in order to better focus public and private interventions on tlie areas of greatest need in terms of clinical conditions, provider types , patient characteristics and practice settings . The second and more important goal is to develop condition-specific guidelines on optimal opioid dosing. While CDC and other groups have set forth general guidelines on the principles of pain management , and some states have established unifo1m limits on the maximum nwuber of tablets or capsules that can be prescribed for a first opioid prescription , clinicians need more detailed and specific guidance on drug choice , dose, and quantity to be dispensed in treating specifi common conditions. Data analytics can build on the overall guidance documents prepared for pain management in general by : a) reviewing the entire existing literature on evidence concerning condition-specific pain therapy , including recommended agents , doses , and quantities ; (b) coovenihg several expert clinician panels to generate condition-specific guidelines for managing the most common indications for pain medications ; and (c) transforming that information into concise , clinically relevant , and actionable recommendations that can be disseminated to practitioners . Pharmacists are under pressure to continue filling prescriptions from irresponsible providers . A recent study of Wisconsin pharmacists found that a not insignificant minority did not understand what is legitimate practice under federal and state laws about evaluating the legitimacy of a controlled substance prescription also known as conesponding responsibility . Fruther , 36% of these pharmacists considered extended prescribiug of opioids to be a violation of law or 1macceptable medical pract ice. In the current crisis , it is critical that all pharmacists and pharmacy programs have the training necessary to responsibly dispense these medications while also not dispensing these powerful medications when the prescription is not legitimate or if it will harm the patient. 18·' 6. The Commission recommends HHS, the Department of Labor (DOL), VA/DOD, FDA, and ONDCP work with stakeholders to develop model stah1tes, regulations, and policies that ensure informed patieot consent prior to an opioid prescription for chronic pain. Patients need to understand the risks, benefits and alternatives to taking opioids. This is not the standard today. 7. The Commission recommends that HHS coordinate the development of a national curriculum and standard of care for opioid prescribers. An updated set of guidelines fol:' prescription pain medications should be established by an expert committee composed of IAPGl ONDCP006FY18004_000000046 ONDCP-18-0107-A-000055 various specialty practices to supplement the CDC guideline that are specifically targeted to primary care physicians. 8. The Commission recommends that federal agencies work to collect participation data. Data on prescribing pattern hould be matched with participation in continuing medical education data to determine program effectiveness and such analytics shared with clinicians and stakeholders such as state licensing boards. 9. The Commission recommends that the Administration develop a model training program to be disseminated to all levels of medical education (including all pre cribers) on screening for substance use and mental health status to identify at risk patients. 10. The Commission recommends the Administration work with Congress to amend the Controlled Substances Act to allow the DEA to require tbat all prescribers desiring to be relicensed to prescribe opioids show participation in an approved continuing medical education program ou opioid prescribing. l 1. The Commission recommends that HHS OOJ/DEA, ONDCP, and pharmacy associations train pharmacists on best practices to evaluate legitimacy of opioid prescriptions, and not penalize pharmacists for denying inappropriate prescription . Enhancing Prescr1ption Drug Mon itoring Programs (POMP) State-based PD MPs are electronic databases that give prescribers and many phannacists access to critica l information regarding a patient's controlled substance prescription h.istory, and whjch can help health professionals identify patients who may be misusing prescription opioids or other prescription drugs and who may be at risk for abuse or misuse. PDMPs are sometimes used by professional licensing boards to identify clinicians with patterns of inappropriate prescribing and dispensing . In most states , law enforcement may use them to investigate cases of controlled substance diversion . In the interim report , the Commission recommended that federal funding and technical support be provided to states to enhance data sharing among PDMPs to better track patient-specific prescription data and support regional law enforcement iJ1 cases of controlled substance diversion (Appendix 3). The commission believes the additional recommendations outlined below will further enhance the effectiveness and uptake of PD MPs across the nation . Today , 49 states and the District of Cohu11biacurrently have legislation authoriz.i11gthe operation of PDMPs in their jurisdictions . However , except in states with mandated POMP use, providers who see patients and prescribe opioids , or have patients affected by opioids , don ' t routinely register for or use PDMP s. The national 111edian PDMP registration rnte among licensed prescribers is only 35%, per a report in the Journal of the American Medical Association published in 2015. Furthermore , a sn,dy by the Johns Hopkins Bloomber g School of Public Health found that patient hist01y was not checked via a PDMP database by the prescriber in 86% of prescriptions for opioids written in 2015. The Federal Government should leverage mechanisms to facilitate POMP use. Congress should pass and the President should sign the Prescription Drug Monitorjng (POMP) Act of 2017, which would mandate the creation and use of PDMPs by states who receive federal fLJndingto fight the opioid crisis. This Act won.Id impose strict POMP requirements , such as a 24-hour reporting IAPGl ONDCP006FY18004 _000000046 ONDCP-18-0107-A-000056 requirement after dispensing a controlled substance , further central ize prescribing data , and would help to facilitate data sharing across the states. 12. The Commission recommends the Administration's support of the Prescription Drug Monitoring (POMP) Act to mandate tates that receive grant fuods to comply with POMP requirements, including data sharing. This Act directs DOJ to fund the estabUshment and maintenance of a data•sharing hub. 13. The Commission recommends federal agencies mandate PDMP checks and consider amending requirements under the Emergency Medical Treatment and Labor Act (EMT ALA), which requires hospitals to screen and stabilize patients in an emergency department, regardless of insurance status or ability to pay. Providers often resist using PDMPs because these systems are no t well integrated into the ele.ctronic health records (EHR systems they currently use in practice , and for other reasons , including inadequate training on the use and complexity of some POMP software programs. The Heller School at Brandeis University recomme nds simplifying the method of access to PD MPs for providers by integrating POMP data into health information exchanges , increasing the likelihood that prescription history information will be used in clinical decision-making. F urthetmo re, many EHR systems also integrate electronic prescribing of controlled substances EPCS). The American Medical Association (AMA) and the American College of Physicians both recommend EPCS as one of the top tactics to combat opioid abuse , as eliminating paper prescriptions wmimprove accuracy , reduce diversion and fraud, as well as improve data quality to PDMPs . However , only the States of Maine and New York have mandated the u e of electronic prescribing for controlled substances (Minnesota bas mandated e-prescribing since 2011 but no enforcement mechanism exists) , and these states are using edicaid reimbursement rates to incentivize providers to use EPCS. Other states have followed suit; Virginia passed legislation manda6n.g statewide £PCS to take effect in 2020 _More recently , Commission member Governor Cooper signed the Strengthen Opioid Misose Prevention (STOP) Act which , as of July I , 2017 , requires electron ic prescribing of certain schedule lf and l1l controlled substances , including opioid medications , in ortb Carolina . Practitioner ability to electronicall y prescribe controlled substances in the United States is currently governed by an interim final rule , which would benefit from a revision so practitioners can take advantage of modern technology that would make registration and use of thi service easter. Practitioners are also hesitant to use PDMPs because they often do not know what to do when they identify patien ts with a potential SUD. Physicians and other health professionals often do not have adequate tra ining in SU Os to assess patients and may need coaching on how to effectively address the issue of a potential SUD . This is especially relevant if the POMP indicates a high-risk patient requiring tapering , alternatives for pain management , and specialry treatme nt for OUD . Inadequate patient support or treatment may compromise the value of the POMP , 184 and promote a transition to illicit opioids if prescription opioids are eliminated. In addition , providers are typically pressed for time and often complain that if a patient is flagged by a POMP they are either m-equipped to screen for an SUD and/or unable to make a successful refenal to specialty SUD ti-eatment programs . ASAM strongly recommends that p.rescribe.rsbe trained in engagement strategies that result in linking patients to treatment when indicated . Integrated decision support tools such as the screening tools used in SBIRT interventions , could also help practitioners make a quick IAPGl ONDCP006FY18004 _000000046 ONDCP-18-0107-A-000057 detennination about the likelihood of a SUD and to recommend appropriate specialty care or an appropriate specialty treatment provider at which to obtain an assessment. There are a number of new and innovatjve tools for providers to determine which patients are at risk of adverse effects from prescription opioids , including accidental overdose or development of an SUD. Some are used at the prov1der level and some analytic tools me used at the payer level to flag certain patients for follow-up or interventions . 14. The Commission recommends that PDMP data integration with electronic health records overdose episodes and SUD-related decision snpport tools for providers is necessary to increase effectiveness. 15. The Commission recommends O DCP and DEA increase electronic prescribing to prevent diversion and forgery. The DEA should revise regulations regarding electronic prescribing for controlled substances. Organizations such as tlle Association of State and Territorial Health Officials (ASTHO) and Palantir recommend that multiple data sources should be integrated , accessible , and up-to-date in PDMPs to rapidly predict and detect outbreak "hot spots" and disease clusters for both public health and law enforcement purposes .1 5 Medical providers would benefit from knowing if patients overdosed so they can adjust their treatment , but currently those records do not flow back to primary care from emergency rooms or emergency responde r s because , in many medical settings . the differing EHR systems are not sufficiently interoperable. Patient privacy laws, while wellmeaning can also hinder the ability to share this information between medical providers. However , the Department of Transportation (DOT) maintains a database of EMT responses for overdoses that could inform PDMPs about patients ' level of risk and provide better decision-making tools for the prescriber. 16. The Commission recommends that the Federal Government work with states to remove legal barriers and ensure PDMPs incorporate available overdose/naloxone deployment data, including the Department of Transportation's (DOT) Emergency Medical Technician (EMT) overdose database. It is necessary to have overdose data/nalo one deployment data in the PDMP to allow users of the POMP to assist patients. Prescript ion Take-Back Programs and Drug Disposal The National Prescription Drug Take Back Day, organized by the DEA with state and local partners , provides communities a safe and convenient way to dispose of their unneeded presc.riptioo drugs, while educa6ng the public about the dangers for the public of abuse and misuse. Providers wrote nearly a quarter of a bill ion opioid prescriptions in 2013. This is enough for every American adult to have a bottle of prescription opioids . 186 Many mrsusers of prescription drugs have indicated they received prescription s from their family and friends ' medicine cabinets. 187 DEA 's Take Back Day, which is heJd twice a year, provide an opportunity for comm.unities to dispose of their unneeded prescriptions. In addition , these events are often community driven and offers the public a venue to bast community health fair and provide information about drug screening and treatment services. Offering dru 0 screening and treatment information and resources during Take Back events encourages friends and family of loved ones with a substance abuse fAPGl ONDCP006FY18004_000000046 ONDCP-18-0107-A-000058 problem to obtain iuforn1ation and support on a convenient walk in basis. There is aJso a need to leverage resomces by collaborating with other health professionals that offer -comprehensive health and substance use services. State s have also established year-rotmd take-back programs in partnership with commnnity stakeholders and local law enforcement agencies . North Carolina ' s ' Operation Medicine Drop ' is the largest take-back program in the U.S. , and has collected nearly 89.2 million pills at more than 2000 events since 2010 . There is an opportunity to increase efforts by encouraging hospitals /clinics with onsite phannacies and retail pharmacies to become authorized collectors . Authorized collectors provide a year-round opportunity for the public to properly dispose of their unused prescriptions . Onsite and retail pharmacies have a tremendous opportunity to aid in increasing collection rates by considering incentivizing the public to drop off their unneeded prescriptions by offering store rebates. In addition , the Federal Government supported the development of drug deactivation bags to allow the safe disposal of old presc1iµtion opioids. Drug deactivation bags would be particularly useful in rural areas wbere an authorized collector may not be nearby. The use of such bags would complement Take Back Day events and give consumers more options . Furthermore, the Federal Government could explore a potential partnership with onsite and retail pharmacies to fund and include a drug deactivation bag with opioid prescriptions. This woufd provide an opportune moment at the time of drug dispensing to educate the patient on and encourage safe drng disposal. 17. The Commission recommends community-based inform the public about drug creening and encourages more hospitals/clinics and retail authorized collectors and explore the use of drug stakeholders utilize Ta.ke Back Day to treatment services. The Commission pharmacies to become year-round deactivation bags. Pain Level as an HHS Evaluation Criteria As a condition of full reimbursement of hospitals , the Centers for Medicare and Med icaid Services (CMS) requires that hospitals rnndomly survey discharged inparients using the post-hospitalization survey the Hospital Con umer A es ·menr of Healthcare Pro\ ider. and ~ tems (HCAHPS). 188 While hospitals must survey only a small percent of patients and response rates are not high (~ 18%), some elect to also use email to survey every patient and use these responses to impro ve their own internal processes. This infom1arion is reported as part of the program for hospital ratings. 'Hospital Compare ,' 189 which offers a public data tool for prospective patients. The tool allows comparison of hospitals across the US on these and other metrics related to patient outcome . During Affordable Care Act (ACA) implementation , the survey became pan of how CMS calculates the VBP Incentive , which gives hospitals maximal reimbursement when they reach certain targets . HHS previously included the pain question response information in calculations of incentive payments , but in 2017 , CMS announced they would stop including the questions in the VBP program calculation. HHS ' s stated reason for removing the pain questions from the VBP calculation was to ensure d1ere would not be any financial incemive or pressure to prescribe. 190 HHS has removed the fonner pain management questions and replaced them with pain management communication questions instead. Moving forward , they intend to continue to include them in HCAHPS. fAPGl ONDCP006FY18004 _000000046 ONDCP-18-0107-A-000059 However , providers and provider associations have expressed they are being required to treat pain with opioids to maintain high ratings . Recent published research since has shown that those with new opioid prescriptions post-discharge are more likely to report their pain was always well managed suggesting that savvy providers have figured out that opioids are a way to manipu1ate satisfaction. 191 This study also found a new opioid claim within seven days of discharge was likely to be associated with an opioid claim 90 days post-discharge in Medicare. 192 Finally , other studies showed ratings of orthopedists performing knee and hip replacement were higher in patients reporting better pain control and orthopedist ratings and sometimes hospital ratings were also affected. 193 • 194 The research suggests that the current approach to pain treatment in the hospital that meets the highest level of response is iatrogenic for ongoing (90-day post-bospital) opioid use. 18. The Commission recommends that CMS remove pain survey questions entirely on patient satisfaction surveys, so that providers are never incentivized for offering opioids to raise their survey score. ONDCP and HHS should establish a policy to prevent hospital administrators from using patient ratings from CMS surveys improperly. Reimbursement for Non-Opioid Pain Treatments A key contributor to the opioid epidemic has been the excess prescribing of opioids for common pain complaints and for postsurgical pain. Although in some conditions , behaviora l programs , acupuncture , chiropractic , surgery , as well as FDA-approved multi modal pain strategies bave been proven to reduce tbe use of opioids , while providing effective pain management , current CMS reimbur ement policies , as well as heaJth insurance providers and other payers , create barriers to the adoption of these strategies . Tn the third Commission meeting , the Commission heard from several innovative pain management and phannaceutical companies about the need for prope.reimbursement of non-opioid pain medications to increase uptake among healthcare providers and limit the use of opioids. For example , the current CMS payment policy for "supplies " related to surgical procedures creates unintended incentives for those that prescribe opioid medications to patients for postsurgical pain instead of administering non-opioid pain medications . Under current policies , CMS provides one all-inclusive bundled payment to hospitals for all "surgical supplies ," which include s hospital administered drug products intended to manage patients ' postsurgical pain . This policy results in the bospitals receiving the same fixed fee from Medicare whether the surgeon admirristers a non-opioid medication or not. Any costs the hospital incurs for creating and administering a multi.modal -pain management strategy essentially get deducted from its fixed fee payment. Thus, ptu-chasing and administering a non-opioid medication in the operating room increases tbe hospital ' s expenses without a corresponding increase in re.imbursement payment. Dispensing and writing a prescliption forpostsurgical opioids , on the other hand , costs the hospital very little , especially since most opioids are generic. lnadequate reimbursement significantly hampers providers ' ability to utilize non-opioid treatment for postsurgical pain. A broader range of pain management and treatment services - including alternati ves to opioids , physical therapy , computerized pain manageme11t educational programming , POMP checking , evidence-based behavioral health treatment , tapering off opioids , and drug testing to confirm adherence - should be adequately reimbursed by payers including CMS. IAPGl ONDCP006FY18004 _000000046 ONDCP-18-0107-A-000060 19. The Commission recommends CMS review and modify rate-setting policies that discourage the use of non-opioid treatments for pain , such as certain btmdJed payments that make alternative treatment options cost prohibitive for hospitals and doctors. particularly those options for treating immediate post-surgical pain. Red ucing and Add ressing the Availabili t y of Illicit Opioids Along with reducing the supply of unne cessary prescription opioids , a major component of prevention is reducing the number of illicit opioids available on the streets , such as herojn , illicit fentanyl and fentanyl analogues or diverted prescription opioids . Jn the omrnission 's interim repmt , the Commission recommended prioritizing funding and manpower to federal law enforcement agencies to develop fentanyl detection sensors , to disseminate them to federal , state . local , and tribal law enforcement age11cies and to support federal legislation to stop synthetic opioids from coming into the cmmtry through the U .S. Postal Service (Appendi 3) . The Commission believes the recommendations outlined below will further address the availability of and staunch the flow of existing and newly emerging dangerous opioids crossing the border into our c01mtry. Imp roving Data Collectio n and Analyt ics The opioid crisis is both a national security and homeland security threat that impacts the health of individuals and the safety of communities . To respond effective ly to this multi-faceted challenge, stakeholders need to access timely and accw-ate information that provides a comprehensive view of the drug environme nt at the federal, state , local , and triba.l levels . Unfortunately , data on drug use, treatment , and public safety ootcomes are managed in different agencies and are ofteo not integrated in a comprehensive way that facilitates the needs of public safety and public hea lth. There is also varia bility in the way key indicators are defined , collected and reported across states making it difficult to monitor and assess regional and national trends . It is imperative that all levels of government develop a set of core public heal th and public safety indicators that can be standardized , collected, analyzed , and shared to inform local , regional and nation.al prevention, education , outreach , treatment , ahd enforcement initiatives. The Federal Government has made considerable in estments in capabilities that facilitate collaboration among federal state , and local agencies to enhance our Nation ' s ability to address various threats affecting our colll.IIlunities. For example , the CDC has provided federal grant funding to se lect states to improve prevention and response efforts by supporting more timely public health data collection , disseminating public hea]tb surveillance findings to key stakeholders within states , and sharing data with the CDC to support improved multi-state public health surveillance. On the public safety side , the exist ing models of public health and public safety infonnation sharing have large ly been supp011ed by federal grant programs and technical assistance administered through the DOJ ' s Bureau of Justice Assistance (BJA), and the CDC. improved coordination among federal departments and agencies related to grant funding and technjca l assistance activities will expand models of public health , behavioral health , and public safety u1fonnation sharin g and collaboration at the state and local level. IAPGl ONDCP006FY18004 _000000046 ONDCP-18-0107-A-000061 Likewise states have leveraged Department of Homeland Security (OHS) preparedness grant funding to effectively implement , in collaboration with federal partners, a decentralized and coordinated information sharing environment to identify . analyze , and share public safety infom1ation across all levels of government and first responder disciplines. Significant strides have also been made to enhance the ation's capacity to collect share, and analyze public safety information , and disseminate actionable and strategic intelligence to key stakeholders from all levels of government. A critical component of the national response to the 9/11 terrorist attacks was the development of a national-le el, decentralized , and coordinated information sharing environment that priori tizes infom1ation security and protects individual privacy , civil rights , and civil liberties. State and major urban area fusion centers, theHi'ghintensity Drul.TTraffic/ringAreas (HLDTA) Program , and Regional lnfom1ation Sharing Systems (RJSS) Centers are some of the key field-based infonnation sharing , rurnlytic, and investigat ive entities that leverage this capability to enable interjurisdictional and multidisciplinary information sharing , and facilitate collaboration among federal , state and local public safety partners to address both local and national threats. rt is sensible to evaluate how investmen ts in the national information sharing environment could be used to support public health and public safety information sharing and collaboration at all levels of government. At the state and local levels, successfu l frameworks for public health and public safety collaboration are expanding. Several states have developed drug monitoring initiatives (DMis) and overdose fatality review teams , while ew York ity has developed the RxStat initiative. These efforts integrate various pub lic safety and public health data sets to include drug overdose deaths , non-fatal overdoses , naloxone administrations , prescriber data, drng arrests drug seizures , and laboratory results . The analysis of these data enables public safety and public health stakeholders to develop and implement prevention , education , outreach , treatment , and enforcement initiatives tbat protect public safety ru1dreduce drug use and its consequences . These data can be used to develop coordinated risk-reduction strategies tailored to local communities or specific regions. 20. The Commission recommends a federal effort to strengthen data collection activities enabling real-time surveil lance of the opioid crisis at the national, state, Jocal, and tribal levels. Jn the United States , medicolegal death investigation (MDI) is conducted via a county-based system of medical examiners and coroners (ME/Cs . There are no national standards for conducting MDI in drug overdose cases ; including when to in estigate a death , any requisite accreditation ofME /C offices and the certification of their investigators , protocols for which drugs to test for and at what cut-off levels, the possibility of suicide , or how or to whom to report findings . The absence of shared standards and procedures prohibits the accurate and timely identification and prioritization of drug threats and the evaluation of the effectiveness of public health and safety policies implemented to abate them. The DOJ and the National Institute of Standards and Technology are cunently leading an effort to staudardize the process for forensic investigations . Consisteucy in the investigation and reporting procedures following fatal and non.fatal drug overdose events will permit improvements to the timeliness ru1d comp letenes s of mortality reporting statist ics and is necessary to make better and more efficient use of limited state and federal fonds. IAPGl ONDCP006FY18004 _000000046 ONDCP-18-0107-A-000062 21. The Commission recommends the Federal Government work with the states to develop and implement standardized rigorous drug testing procedures, forensic methods, and use of appropriate toxicology instrumentation in the investigation of drug-related deaths. We do not have suffidently accurate and systematic data from medical examiners around the country to determine overdose deaths, both in their cause and the actual number of deaths. Estimates of the extent of tbe opioid epidemic in the United States may be underestimated due to inadequate systems reporting information on the number , location , and degree of opioid consequences . Surveys of chronic drug users and morbidity information could provide timely and in-depth insights into the opioid crises but were defunded from the budgets of federal agencies . Current data systems do provide some level of measurement, but miss some important aspects of the opiojd epidemic . Restoration of funding for these terminated programs is needed to obtain more detailed information on the opioid epidemic. The unique aspects of opioid drugs exacerbate the issues of monitoring the misuse problem , unlike other illicit drug s such as marijuana , cocaine , or methamphetru11ine. Cocaine , for example , has been a drug of consequence for decades , is abused by millions of people in the United States , and has limited variations in composition. Data systems monitoring the extent of the cocaine problem have been standardized ru1d instiru.tional ized . Opioids , on the other hand, consist of mru1y drug varieties , including prescription pain medications heroin , and most recently , illicitlymanufactured fentanyl. Millions of people misuse prescription pain medications , but only a small fraction of that nwnber abuse heroin. These fewer numbers present a challenge for estimating the prevalence of use by the standard federal survey. For example the SDUH , a federal statistica l survey of about 70,000 Americans annually (cited often throughout this report), estimated that 600,000 people used heroin in 2010. 195 A srudy conducted by the RA D Corporation on illicit drug e,xpenditures in America estimated the number of heroin users in 2010 to be closer to 1.5 million . 196 This dramatic discrepancy has been discussed by the press .19 7 IUicitly-produced fentanyl , another rapidly growing component of the opioid epidemic is not even routinely tracked by surveys such as NS DUH or drug seizure data systems. Two discontinued data systems t hat would provide enhanced fidelity to measuring the extent of the opioid crisis are the Arrestee Drug Abuse Monitoring (ADAM) Program and the Drug Abuse Warning Network (DAWN) . ADAM was a survey of current local high-risk arrestees in jails accompanied by a urinalysis test. Unt il its termination by the National Institute of .Justice in 2003 over 30 jail s in cities throughout the country were sampled and tested. Tbese data would provide timely , geo-specific data on opioid use supported with a confinnatory lab test. The lab analysis could also be adjusted to test for any new opioids appearing in the U.S. market. DAWN was a tabulation of drug mentions in hospital emergency rooms. SAMHSA funded the DAWN program until 2011 . These morbidity data would provide a sentinel system, alerting decision makers of the consequences of opioid use before more serious overdoses would occur . E isting data collection systems , including the major surveys like the NSDUH and the Monit oring the Future study , need to be maintained and impro ved, and the data gaps need to be filled and revitalized using such novel approaches such as testing wastewater in highly circumscribe d regions (e.g . a few blocks) for estimating drng metabolites. This innovati e system has already collected biological specimens from high-risk populations for early indications of the changing drug landscape . Population-level data from toxicology screening can also provide a snapshot of drug IAPGl ONDCP006FY18004 _000000046 ONDCP-18-0107-A-000063 use and misuse . Local information is essential to complement national data in informing public health and public safety responses to the opioid epidemic. The possibility of a bebavioraJ health surveillance system at sent inel sites across the country exists for 12+ sites currently under NIDA ftmding ru1dadditional resotlfces have recently been awatded by CDC to 44 states and the District of Columbia to include better tracking of opioid-related overdoses . There is a need for an integrated system that, across the country , can track prevalence rates , treatment modalities and comotbidities with other illnesses in real-time. Recogn izing that there is variability across the United States , these surveillru1ce or sentinel sites can be established for a multitude of local areas across the coru1try. 22. The Commission recommeods reinstituting the Arrestee Drug Abuse Monitol'ing(ADAl\1) program and the Drug A buse Warning Neh,1ork (DAW 1) to improve data collection and provide resources for other promising survemance systems. Disrupt ing the Illicit Fentanyl Supply The emergence of illicitly produced fentanyl and fentanyl analogues -in the drug market has drastically compounded tbe illicit opioid problem. Increasingly , fentanyl and fentanyl analogues are combined wi th inert substances and pressed into pill f01m to be sold as counte1feit prescription opioid pills. To help deter these features of the illicit dntg market , changes to sentencing guidelines are underway in many states and in various stages of maturity. In Massachusetts. any person who traffics ' in fentanyl , "by knowingly or intentionally manufacturing , distributing , dispensing or possessing with intent to manufactllfe , distribute or dispense or by bringing into the commonwealth a net weigh t of more than IO grams of fentanyl " faces punishment of up to 20 years in state prison . The term "fentanyl " includes any derivative of fentanyl and any mixtllfe containing more than IO grams of fentanyl or a derivative of fentanyl. M.G.L.A. 94C § 32E (c ½). As of July 2017 , West Virginia law specifically criminalizes the unlawful manufacture. delivery transport into state , or possession offentanyl. W. Va. Code.§ 60A--4-415. A violation is a felony, with the following prison tenns: I) if the net weight of fentanyl involve d in the offense is less than one gram , such person shall be imprisoned in a correctional facility not less than two nor more d1an ten years ; (2) if the net weight of fentaoyl invol ed in the offense is one gram or more but less than five grams , such person shall be imprisoned in a coITectionaJ facility not less than three nor more than fifteen years ; and (3) if the net weight of fentanyl involved in the offense is· five grams or more such person shall be imprisoned in a correctional facility not less than four nor more than twenty years . New Hampshire law defines the te.rm "fentanyl class drug " w ith reference to a listing of specific substances . N .H . Rev . Stat.~ 318-B : l(XI-a.) . These drugs are assigned the same criminal penalties as are heroin or crack cocaine. N .H. Rev. Stat.§ 318-B :26. While states consider laws that aim to reduce the supp ly of fentanyl , including harsher penalties for smaller quantities given the potency it is also important to consider whether users , who buy fentanyl utu..'11owingly , could be unnecessaTi.Jypunished for distribution. For indiyjduals with OUD who are arrested with fentanyl. other factors beyond quantity should be considered to determine possession for personal use versus distribution. fAPGl ONDCP006FY18004 _000000046 ONDCP-18-0107-A-000064 23. The Commission recomme nds the enhancement of federal entencing penalties for the trafficking of fentanyl and fentanyl analogues. As mentioned above illicit fentanyl and fentanyl analogues are increasingly being pressed into counterfeit prescription opioid pills, often mimicking the appearance of commonly prescribed opioid pain killers such as OxyContin , by Drug Trafficking Or ganizatio ns (DTOs) and smuggled into the United States in large quanti ties. While fentanyl seizures are most typically in a powder , salt, or rock-like form, DEA ' s El Paso Intelligence Center (EPIC) reports an increase in the number of pills seized. In 20 J6 an estimated 15,632 domestically seized tablets and capsules were identified by DEA forensic laboratories as containing some amount of fentan yl or fentanyl analogues with or without other illicit drugs and non-narcotic substances . This represents appro ximate ly 16 times the munber of fentanyl tablets and capsules analyzed by DEA ' s laboratories in 2014 . 19~ Fentany l in pill form bas enabled the development of a more diverse user popu lati on that is skewing younger and perhaps more opioid naive. Moreover , the prototypical experienced intravenous drug use r of previous illicit opioid crises has been jo ined by those who believe they are buying off-market prescription opioids, but are in fact buying fentany l pressed into pill fmm . Fmthennore, the online marketplace and cryptocun-encies have empowered a "democrati zation of the dnig trade, " where the hierarchical DTOs the United States has effectively confronted for the past several decades no longer ha e a monopoly oh supplying drngs. Rather, individuals can simply go online to one of many internet drug marketplaces and purchase illicit drngs for their own personal use or for further sale on a limited scale , creat ing a constellation of ''micro-networks" across the country that are diffi cult to locate and nearly impossible to dismantle _ The ability to easily purchase drugs like fentany l online , which are subsequentl y shipped in a manner and at volu mes that make them hard to detect, demonstrates a new pathway for these potent mugs to enter the domestic supply chain. This change carries enormous implications for the law enforcement and justice communities , and requires a framework of relationships, laws and regu lations , and procedures to deal with an environment of dru g traffickin g and use the nation is just beginning to see . The growing internet drug market , particular ly for fentanyl and fentany l analogue s, is a clearly identified cr itical vulnerability in interrupting the supply of these mugs into the United States . Since the 2013 closin g of the first well-known cryptomarket Silk-Road 1.0, both the clear and the dark web havefurth et expanded the illicit drug market allowing individuals to purchase dangerous drugs directly from their manufacturers instead of throu gh established trafficking organizations. lntemet sales of fentanyl and other synthetic substance s has evolved into a direct to consu mer market generatin g large revenues . A Carnegie Mellon University study estimated that revenues from on line illicit drug sales increase d from between $ 15-17 million in 2012 to$ 150-$180 million in 2015. 199 The rece nt multi-agency and internationa l effort , led by the DOJ , which resulted in the takedown of the Alphabay marketplace was a monumental step forward in tl1is effort. The dynamics of synthetk drugs and their a ailability ohline has the potential to permanently change the drug market. The Federa l Government currently lacks a susta ,ined, coordinated , and well-resourced effort to attack tl1e illicit drug on.line purchase infrastrucnire to identify and target the network of actors involved , and limit the amount of fentanyl and fentany l analogue s entering the United States _ IAPGl ONDCP006FY18004 _000000046 ONDCP-18-0107-A-000065 24. The Commission recommends that federal law enforcement agencies expressly target Drug Trafficking Organizations and other individuals who produce and sell counterfeit pills, including through the internet. The importation of tableting machines (pill presses) is regulated by DEA. DEA has recently enhanced importation regulations by replacing paper reporting with an electronic process. However , the active use of pill presses rnmains unregulated. While DEA currently can inspect a registrant s use of controlled substances in their usable form to verify they are well stored and used for their stated registered purposes , the DEA currently cannot inspect pill presses to verify tJ1at equipment is not being used to produce counterfeit drugs . 25. The Commission recommends that the Administration work with Congress to amend the law to give the DEA the authority to regulate the use of pill presses/tableting machines with requirements for the maintenance of record , inspections for verifying location and stated use,. and security provisions. lnterdictfon and Detect ion Challenges The detection of fentanyl and its analogues shipped directly into the United States via international mail and express consignment presents a unique challenge . U.S. Customs and Border Protection (CBP) is responsible for interdicting and screening inbound intemational mail before all letters , parcels , and packages are released to the U.S. Postal Service (USPS) for domestic delivecy. The CBP operates within nine major USPS International Mail Facilities (IMF), inspecting international mail and parcels arriving from more than 180 countries . CBP partners with the U.S. Postal Inspection Service (USPIS) at each facility to target , detect, and seize international shipments of illicit narcotics , including fentanyl. International mail processing is primarily manual , requiring BP officers to sort through large volumes of parcels to identify potential shipments of concern . CBP screens all international mail parcels for radiological threats , x-rnys all international mail packages presented by USPS , and physically examines those deemed high -risk. The USPS processed over 275 million international inbound mailings in FY 2016. Of those items , there were over ten million international express mail items and over four miJlion air and surface parcels . ln FY 2016 , the USPIS initiated 2,439 cases involving drug trafficking and made 1,850 arrests which resulted in 1,57 l convictions . Additionally , inspectors eized illegal assets valued at approximately $23.5 million , to include 89 pow1ds of heroin , 13,968 Oxycodone tablets , and fentanyl-family synthetic opioids on 36 occasions . 1n these cases , USPIS utilized inteltigence derived from drug seizures, international partnerships , and strong relationships with federal , state , local and tribal law enforcement agencies . Because of the increased threat of fentanyl , and the interagency focus on disrupting the fentanyl supply chain , CBP undertook a pilot program to train canines to detect fentanyl. A ltl10ugh training canines to detect synthetic drugs is a difficult undertaking , the CBP has already trained and fielded canines and placed them in critical locations in the United States to screen incoming parcels to indicate the presence of fentanyl and other synthetic opioids. Canine screening and detection , complemented by the deliberate targeting of shippers associated with fentanyl trafficking , has the potential to increase the likelihood that those containing illicit opioids are seized and removed from the supply chain . IAPGl ONDCP006FY18004_000000046 ONDCP-18-0107-A-000066 The incredibly high volume of mail, feutanyl's ability to be shipped in very small quantities , a low number of available automated detection systems , and the relatively small number of trained canines make intercepting fentanyl and fentanyl analogues at IMF ' s monume:n.tally difficult. 26. The Commission recomroeods U.S. Customs and Border Protection (CBP) and the U.S. Postal Inspection Service (USPIS) use additional technologies and drug detection canines to expand efforts to intercept fentanyl (and other synthetic opioids) in envelopes and packages at international mail processing distribution centers. The sheer volwne of international mail and IMF infrastructure make interdiction efforts focused on illicit opioids and other drugs a monumental task. One method to address this issue is the increased use of Advanced Electronic Data (AED). Federal regulation requires express package operators to transmit AED prior to package arrival io the United States. AED consists of electronic data aboUt the paniculars of each shipment such as sender /receipt names and addresses , contents and quantity . AED's primary use is for advanced targeting for CBP inspections efforts. With AED, CBP can advance-tar 0 et incoming shipments for additional examination based upon intelligence , prior violations , and other risk factors. Over 90% of inbound international mail is sent from USPS ' s top-volume trading partners. USPS now receives AED on inbound packages from 20 countries , including China . International mail services are not required by International law to transmit parcel infonnation prior to arrival in the United States and many do not have the capability to do so even if required. However , international law requires nations estabhshing such requirements to ensure they can be met by all nations. To this end, the Commission recommends support of the Synthetics Trafficking and Overdose Prevention (STOP) Act of 2016 or the STOP ACT of 2016 , which amends the Tariff Act of 1930 to make the Postmaster General the importer of record for non-Jetter class mail imported into the United States. The bill amends the Consolidated Omnibus Budget Reconciliation Act of 1985 to impose a duty of $1 on each item of non-letter class mail imported into the United States . The bill amends the Trade Act of 2002 to direct the Department of the Treasury to require the Postmaster General to provide for AED transmission to CBP of certain information on non-letter class mail imported into the United States. 27. Tht> Commission recommends Congress and the Federal Government use advanced electronic data on international shipments from high-risk areas to identify international suppliers and their U.S.-based distributors. 28. The Commission recommends support of the Synthetics Trafficking and Overdose Prevention (STOP) Act and recommends the Federal Government work with the international community to implement the STOP Act in accordance with international laws and treaties. DEA repor1s that diversion oflicit fentru1yl, either from theft or fraud , currently accounts for about 2-3% of fentanyl-related overdose deaths . However , as government agencies and international partners achieve success disnipting the illicit fentanyl supply chain , there is high confidence that the licit fentanyl . as well as other prescription opioids, stock and supply cl1ain will e peneoce an increased risk of diversion. IAPGl ONDCP006FY18004_000000046 ONDCP-18-0107-A-000067 Jo 2011 , Commission member Florida Attorney General Bondi fought for the passage of House Bill 7095 Florida Legislatme , which aimed to regulate ' pill mills , by combating prescription drug diversion. Specific features of Florida ' s legislation included adding new criminal penalties , requiring wholesale distnbutors to credential customers and repo1t on distribution of controlled substances, as well as fundin g state Regional Drug Enforcement Strike Forces . Within 18months of the legislation passage , Florida achieved the largest-by an order of several magnitude-year-onyear recorded drops in prescription drug overdose deaths in the nation . At any point in the manufacturing , distribution and prescription process, fentanyl, like othef prescription opioids , can be diverted for illicit use. The nation should re-examine its current procedures to track the licit supply chain to prevent the diversion of precursor chemicals, partially processed product, and finished material in manufacturing facilities . Additionally , there are few mechanisms to track fentanyl and prescription opioid diversion once the drug is issued by a medical professional to a patient for consumption. One such method could be a requirement for the recipients and users of legally prescribed fentanyl to pro ide proof , such as empty n·ansde1m.al patch envelopes or lollipop sticks to a pharmacist before receiving their refills. Another control initiative could be placing restrictions on dispensing fentanyl through the mail, or requiring that packages containing fentanyl or other opioids must be signed for by the recipient. The DEA must be able to successfully disrupt the diversion of prescription opioid at any and all points in the supply chain . 29. The Commission recommends a coordinated federal/DEA effort to prevent, monjtor and detect the diversion of prescription opioids, incl11dingJicit fentany], for illicit distribution or use. Protecting First Responde rs from Harmful Effects Resulting fro m Exposure to Fentanyl and other Synthetic Opioids The increased prevalence of fentauy] and other synthetic opioids in the illicit drug market requires law enforcement, fire, rescue, and emergency medical services (EMS) personnel to understand how to protect themselves from exposure to these substances. There have been reports nationwide of Jaw enforcement professiouals and EMS professionals experiencing opioid overdoses after unknowingly coming into contact with fentanyl residue . Similarly , crime labs do not always have updated policies and procedures for dea ling with potentially deadly substances st.1chas fentanyl. Currently , fear and misinformation regarding potential health concems to first re ponders are hindering response efforts and increasing the risk to first responders. To make the environment more challenging , fentanyl can be present in a variety of fonns (e.g. , powder , tablets , capsules , solution , etc.). At the state and federal level, there is no systematic method of tracking and examining reports of first responder opioid intoxication due to inadvertent exposure to fentanyl. Establishing uniform data collection and sharing protocols across states , including conducting confirmatory testing and collecting specific information about each incident of suspected first responder opioid intoxication , would assist the first responder community in validating and refining safety recommendation s. The White House convened and coordinated an interagency working group that included medical, public health , law enforcement , and EMS subject-matter experts to develop a set of scien tific [APGl ONDCP006FY18004 _000000046 ONDCP-18-0107-A-000068 evidence-based recommendations for first responders to protect themselves from the harmful effects associated with fentanyl exposure. As noted in Appendix 4, the Fentany l Sq/et; Recommendations for First Responders are included in this repott to ma · imjze awarene s. The Commission commends the Federal Government for providing unified recommendations to frontline personneL We also acknowledge the interagency working group for recognizing the value of incorporating feedback from stakeholder representatives from the medical , public health. oc-cupational safety and health, law enforcement and fire/EMS fields. 30. The Commission recommends the White House develop a national outreach plan for the Fentanyl Safety Recommemlations for First Responders. Federal departments and agencies should partner with Governors and state fusion centers to develop and standardize data collection, analytics, and information-sharing related to first responder opioid-intoxication incidents. IAPGI ONDCP006FY18004_000000046 ONDCP-18-0107-A-000069 Op ioi d Addic t ion Treat men t , Overdose Reversal, and Recovery Drug Addiction Treatment Services In the interim report, the Commission reported that tbe use of MAT has been associat ed with reduced overdose deaths , retention of persons in treatment , decrease d heroin use, reduced relapse , and prevention of the spread of infectious disease . The Commi ssion recommended seve ral steps to increase the use of and access to all forms of SUD treatme11t, including MAT for SUDs , includ ing removing the federal Institutes of Mental Diseases (IMD) exclus ion within the Medicaid program , estab lishing a federa l incentive to enhance access to MAT , and requiring regulators to take enforcement action against health plans that viola te the Mental Health Parity and Addic tion Eq uity Act (MH PAEA) (Appendix 3). The Comm ission also expressed suppo1t for the Overdose Prevention and Patient Safety Act/Protecting Jessica Grubb 's Legacy Act, and the need to updat e patient privacy laws , such as 42 CFR Part 2, to ensure that information about SUDs are made available to medical prof essionals treating and prescribing medication to patient s. Building off the previous recommendations , the Commiss ion supports implementation of the steps outlined be low to remove additional barriers and further improve access to and quality of drug addiction treatment services across the nation. Increase Screenings and RefetTals t o T reatm ent through CMS Quality M easures There is a great need to ensure that hea lth care prov iders are scree ning for SUDs and know how to appropriately counse~ or refer , a patient that presents with an SUD .200 As Commiss ion membe r Dr. Bertha Madras found in her analysis of a SAMHSA SBTRT pro1:,"'Tam , training practitioner s in hospitals and primary care settings in the SBIRT model can be effective in red ucing rates ofalco hol and illicit drug use . Io this 2009 study, nearly 500,000 individual s were scree ned in six states across hea lth care settings and those that demonstrated alcoho l abuse and/or illicit drug use were give n a brief intervention, brief treatment , or a referral to specia lty treatment. 201 A variety of screening too ls were employe d, and study sites had differences in population demograp hics and substance use r ates; however , across all sites and demograph ics, self-reported substance use was less at six months after the initial screen and a brief or more inten sive inter vent ion. This resear ch demonstrates the effect iveness of addiction screening in a health care setting , as well as the potential to better utilize prima1y care medical professio nals in areas where there is a shortage of speci alty treatment providers. There are opportu nities to further the pract ice of substance use screen ings and referrals through CMS qual ity measures . CMS has several quality measw·es thronghout their program s (Medicaid , 1115 demonstrations , Innovation Acce lerator Program , Medicare , etc .) that could h elp further the practice of sub stance use screen ings and referrals to treatment. The Federal Government , in coord ination with the private sector, has a process through which measures are identified , spec ified and implemented to assure good patient health outcomes. All federal programs have different purposes and author ities and the selection of measures will vary to reflect those differen.ces. At the same time , federa l programs str ive to adopt measure s that wi ll have strong reach without overw helming provider s with reporting requi rements . There are current ly severa l substance use measu res being used in federa l and private quality assurance programs , and many more under lAPGl ON DCP006FY 18004 _ 000000046 ONDCP-18-0107-A-000070 consideration for adoption. However , measures are not deployed across all programs and in some cases , do not address some of the gaps in care. Quality measures for substance use screenings and referrals to treatment should address immediate treatment (24-48 hours) at aJl points of care for indi iduals in need of an assessment and treatment for OUD , jncfudjng hospital induction of MAT , strengthening coordination of care and referral efficacy /improved treatment linkage , follow-up morutoring , and adoption of 'hnb-n-spoke ' models where specialty providers provide clinical support for primary care-based high need patients . High rates of co-morbidity with mental health disorders also warrant substance use screenings when a mental health diagno sis has been made . JJ. The Commission recommends HHS, CMS, the Substance Abuse and Mental Health Services Administration (SAMHSA) , the VA, and other federal agencies incorporate quality measures that address addiction creeoings and treatment referra ls. There is a great need to ensure that health care providers are screening for SUDs and know how to appropriately counsel, or refer a patient. HHS should revkw the scientific evidence on the latest OUD and SUD treatment option and collaborate with the U.S. Preventive Services Task Force (USPSTF) on provider recommendations. Evidence-based Improvements to Treatment Addiction is a chronic relapsing disease of the brain which affects multiple aspects of a person ' s life. ln addition to efforts to improve access to treatment. public policy should also seek to impro ve the efficacy of treatment. Effective treatmen.t must address the needs of the whole person to be successfnl. Research by NIDA outlines I 3 principles upon which effective treatment programs and pract ices are built. 202 Grounded in these principles , a growing body of evidence-based models guides the work of addiction treatment. 203 Models demonstrating the greatest outcomes tend to incorporate behavioral , psychosocial , and phannacological elements , if available ,204 and are tailored to the individual client. The ability to adopt evidence-based models depends on provide r ability to support skilled staff who are appropriately credentialed and/or licensed to implement necessary practices. h1surers and other payers can create pressure on treatment providers for a consistent , high-quality standard of care. Treatment should include the following five elements :105 I . Complete evaluation for OUDs by a qualified medical professional including co-occuning other SUDs , psychiatric disorders, and medical disorders . 2_ Access to MAT (e _g., methadone , buprenorphine /nalox_one, naJtrexone)_ Choice of medication should be made by a qualified professional .in consultation with patient , and based on clinical assessment. 3_ Simultaneous access to adjunctive psychosocial treatment that may include: group therapy , individual counseling , family therapy , relapse prevention , other psycbosocial treatment. These services may be delivered in a variety of levels of care depending on what is clinically approptiate including i11patieot, outpatient , intensive outpatient , residential . or partial hospitalization , depending on what is clinically appropriate for the client based on assessment. 206 IAPGl ONDCP006FY18004 _000000046 ONDCP-18-0107-A-000071 4. Treatment of co-occurring psychiatric disorders : The majority of patients with OUDs have cooccuning psychiatr ic disorders , especially trawna related disorders such as PTSD depression , and anxiety disorders . Patients with OUDs who do not receive treatment for these mental health conditions generally have poor treatment outcomes . 5. Treatment of co-occurring med ical conditions : Patients with OUDs may require treatment for the many medical condjtions e.g., cardiac infectious , dermatologic , among others). , Connecting treatment to social supports such as stable bousing , employment /job tra1111ng education /vocational trajning medical care , transportation , child caTe, etc . is also needed on an ongoing basis to help the individual be successful in their recovery and rebujld a lifestyle that is healthy and productive .207 ,20 Reports by the Agency for Healthcare Research and Quality (AHRQ) at HHS endorsed process measures that emphasize treatment completion as key to achieving positive behavioral health outcomes . Similarly , the ational Quality Forum , an organization that works to make in1provements in healthcare , endorsed the adoption of process measures to count and increase the number of adults in MAT programs who receive at least 180 days of continuous treatment. 209 Subsequently, services that facilitate client retention and engagement to at least 180 continuous treatment days will improve client outcomes . However , providers , practitioners , and funders often face challenges in translating such piinciples into practice to help individuals achieve positive long-tenn outcomes. Improvin g the quality of treatment programs win require increasing the number of skilled psycluatrists medical practitioners counse lors, recovery coaches , and impro -ing business practices of providers which facilitates adoption of evidence-based practices such as MAT. Additionally, persons seeking care need user-friendly information on quality program and selection criteria to identify programs that match their needs. Use of evidence-based assessment tools and processes will help determine the appropriate level of care and configuration of services needed by the individual client. Adoption of ASAM 's patient placement criteria should guide referral to the appropriate setting , frequency , and duration of services . 32. The Commission recommends the adoption of process, outcome and prognostic measures of treatment service as presented by the National Outcome Measurement 210 and the American Society of Addiction Medicine (ASAM). 211 Addiction is a chronic relapsing disease of the brain " Inch affects multiple aspects of a person's life. Providers, practitioners, and funders often face challenges in helping individuals achieve positive long-term outcomes without relapse. Insurance and Reimbursement Barr iers to Accessing MAT There are currently three FDA-approved medications for the treatment of OUD : methadone (an opioid agorust), buprenorphine an opioid vartial agonist) and naltrexone (an opioid antagonist ). MAT for OUD is associated with decreases in opioid use, opioi.d-related overdose deaths , criminal activity , and infectious disease transmission , while improving social functioning and retention in treatment. 212 Despite thjs less than half of privately-funded SUD treatment programs offer MAT and only a third of patients with QU O at these programs receive it.213 Though rural areas have high rates of OUD , treatment options , inclurung those that utilize MAT, are mill.imal.2 14 Furthenuore , physicians that have the necessary training and DEA authorization to prescribe buprenorpbine are limited in the number of patients they can treat. IAPGl ONDCP006FY18004 _000000046 ONDCP-18-0107-A-000072 There are commercial insurance barriers to MAT , s11ch as dangerous fai I-first protocols and onerous and frequent prior authorization requirements . Fail-first approaches require that a patient try counseling or other psychosocial approaches before being offered more intensive foons of treatment, or MAT. Families , consumer , and treatment providers have consistently identified these and other barriers to obtaining insurance co erage for opioid and other SUDs. These practices are not evidence-based and are not a tenable clinical protocol for individuals with OUDs , as they delay treatment and in doing so, open a window for renewed opioid use and potential death_ Prior authorizations may also serve as a barrier, as they can take a significant amount of time and can disrupt the clinical 'moment' when a patient has finally agreed to try treatment. A 2017 survey of physicians indicated that prior authorization requirements by third party payers were the most commonly reported banier to prescribing. 2 l5 Tn 2015 48 Medicaid programs required prior authorization for buprenorphine. 216 With addiction , the initial goal is to rapidJy and immediately engage a person in treatment . Rapid response is necessary to secure treannent before an individual goes into withdrawal and seeks drugs illegally in search of relief . ln addition . CMS policies regarding MAT for Medicare recipients are complex and create baffiers for Medicare patients seeking access to MAT . Methadone is covered under Medicare Part D when prescribed for pain, but not when given as pat1 of an OUD treatment program . Some MAT reimbursements are part of a bundled payment for inpatient care, but it has come-to the attention of the Commission that bundled payments can be a barrier to providers offering an array of services and medications. 33. The Commission recommends ID-IS/CMS, the Indian Hea lth Service QHS), Tricare, the DEA, and the VA remove reimbursement and policy barriers to SUD treatment, including those. such as patient limits, that limit access to any forms of FDA-approved medication-assisted treatment (MAT), counseling, inpatient/residential treatment, and other treatment modaUtie , particularly fail-first protocols and frequent prior auth.orizations. All primary care providers employed by the above-mentioned health systems should screen for alcohol and drug use and, directly or through referral, provide treatment within 24 to 48 hours. Reimbursement rates for SUD treatment services are typically lower than those for other health conditions. P1ivate and public insurers complain that they cannot find enough quality providers for their networks , The provision of SUD treatment~ often in the form of counseling and psychosocial services , has a different business and service model than other health conditions. Lack of sufficient reimbursement impedes the ability of professionals and practices to implement high-quality and consistent care, including but not limited to the use of EH Rs. the implementation of evidence-based practices , and the routine use of quality metrics . Moreover , the disincentives are so significant that many practitioners no longer take insurance , diminishing access to care even when there appears to be sufficient capacity. Such differential reimbursement strategies exist in the hospital setting as well. Hospital chemical dependency units, for instance , are paid lower rates than inpatient psychiatric facilities. 34. The Commission recommends HHS review and modify rafe..setting (including policies that indirectly impact reimbursement) to better cover the true costs of providing SUD treatment, including inpatient psychiatric facility rates and outpatient provider rates. IAPGl ONDCP006FY18004_000000046 ONDCP-18-0107-A-000073 Enforcing the Mental Health Parity and Addiction Equity Act (MHPAEA) Spearheaded by Commission member former Congressman Kennedy, MHPAEA aimed to bnild upon the patient protections enacted by the Mental Health Parity Act (MHPA) passed in 1996, which provided that large group health plans could not impose annual or lifetime dollar limits on mental health benefits that are less favorable than any such limit s imposed on medical /surgical benefits. In other words, parity is a simple concept that requires health insurance plans to offer behavioral hea lth coverage that is comparable , and equal to, the coverage for physical health. In reality , creating appropriate parity regulations , and enforcement of parity laws, is far from simple. MHPAEA extended these parity requirements to SUDs , but legislation did not require large group health plan s and health insurance carriers to cover mental health or SUD benefits. Tbe Affordable Care Act changed this by requiring coverage of mental health and SUD services as an esse ntia l health benefit in individual and small group p lans . Howe ver , while parity is a legal requirement , the existing means of monitoring and enforcing tbe parity act are insufficient. The sole means of enforcement under the parity act is equitable relief against the buyer of the insurance plan ; and for the employer~based plans that are self-funding, DOL is presently pennitted to enforce MHPAEA against only the employer , rather than the insuran ce company administering the benefits. The Commission heard from numerou s organizations , suc h as the Parity Implementation Coalition , the Partner ship for Drug-Fre e Kids , the Nationa l Council for Behavioral Health , Shatterproof , ASAM , and the American Academy of Addiction Psychiatry , about the need to systematically monitor and enforce MHPAEA to ensure parity in the coverage of mental health and addiction services. MHPAEA has been the impetus for much progres s towards parity for behavioral health coverage ; plans and employers have , by and large , done away with policies that are clear v iolations ; provisions such as dollar-limits , visit limits, and outright prohibitions on certain treatment modalities that exist only on behavioral health benefits . However , what remains are violations that are murkier and harder for regulators to discer~ for example , non-quantitative treatment limits (NQTLs). These hurdles include medical nece ssity reviews that are more stringent on the behavioral health side than the mectical/surgical side, limited provider networks , and onerous priorauthorization requirements. In reality , it is often difficult to discern when a beha vioral health benefit is "o n par " with a medical /surgical benefit as different care settings and diagno ses have different policies regarding benefit s, providers , and authorizations . One goal of MHP AEA and other parity laws was to address cost-shifting from the commercial sector to the public sector for the financing of substance use and mental health treatment. Expanding the pri vate sector share of expenditures could increase access to treatment for opioid and other drug use disorders. As of 2014 , private cost-sharing did not increase in proportion to the private sector share of the insurance market. It financed only 18% of SUD treatment in 20 14. Legislative changes providing DOL with the ability to impose a civil monetary penalty , such as those provided for violation s of the Genetic Information Nondiscrimination Act (GINA) , would encourage private insurance companies , and employers, ro satisfy their legal obligations under MHPAEA and in tum , ensure they aJe adequately doing their part to address the country's opioid epidemic. HHS has built an online portal to help individuals who have troub le accessing behavioral beaJth services, including addiction treatment. This portal , available at https://www. hhs .gov/mentalhealth-and-addiction-insurance-help /index.html , directs indi viduals to different sites, includin g fAPGl ON DCP006FY 18004 _ 000000046 ONDCP-18-0107-A-000074 DOL , depending on the type of insurance coverage. The Commission applauds this project as wel I as the other activities of the Federal Mental Health and Substance Use Disorder Task Force in working towards public education and full parity compliance. Building upon the recommendations provided in the interim report, the Commission believes the following actions will help to ensure parity violations do not impede access to substance use treatment. 35. Because the Department of Labor (DOL) regulates health care coverage by many large employers the Commission recommends that Congress provide DOL increased authority to levy monetary penalties on insurers and funders, and permitDOL to launch iovestigations of heaJth insurers independently for parity vioJatioos. 36. The Commission recommends that federal and state regulators should use a standardized tool that requires health plans to document and disclose their compliance strategies for non-quantitative treatment limitations (NQTL) parity. QTLs include stringent prior authorization and medical necessity requirements. HHS in consultation with DOL and Treasury, should review clinical guidelines and standards to support NQTL parity requirements. Private sector insurers, i.ncluding employers, should review rate-setting strategies and revise rates when necessary to increase their network of addiction treatment professionals. MAT in t he Criminal Justice System In the weeks following release from jail or prison , individuals with or in recovery from OUD are at elevated risk of overdose and associated fatality . MAT has been fow1dto be correlated with reduced risk of mortality in the weeks following release and in supporting other positive outcomes _ A large sn,dy of individuals with OUD released from prison found that individuals receiving MAT were 75% less likely to die of any cause and 85% less likely to die of drug poisoning in the fu·st month after release .217 Compared to approaches that do not include FDA-approved medications , MAT for OUD is associated with better treatment retention ,218 reductions in the spread of infectious cLiseases, such as HCV and HIV and lower rates of criminal behavior. 2 t 9, 220 -~2 1,222,223, 224 Despite the research evidence a national survey of corrections staff in 14 states found very limited use of MAT. While 83% of prisons and jails offered some form of MAT , its use was limited mostly to detoxification or to maintenance treatment for pregnant women. 225 •226 One study found that nearly 60% of jail personnel surveyed strongly disagreed with the statement that their tax dollars should support methadone treatment. The same survey found that nearly 55% of jail security personnel agreed with the statement that "people who overdose on heroin get what they deserve. " Twelve percent of jail health services staff shared this perspective . The authors noted tbat negative attitudes regarding MAT appeared to be related to negative judgments about dtug users in general and heroin users in particular. 227 Whjle the National Institute on Corrections (NJC), the BJA the National Association of Drug Court Professionals (NADCP) , and other entities have made significant strides in educating correctional administrators and practitioners , much progress remains to be made . Warranting special concern are pre-trial detainees invol ed in the criminal justice system. The population of pre-trial detainees is se era] times larger than the population of indi iduals sentenced [APGl ONDCP006FY18004 _000000046 ONDCP-18-0107-A-000075 to jail. These individuals may be less likely to receive treatment and other services due to the fact that they may be released or transfeITed in a relatively sh011period of t-ime . Increasing access to treatment , and especjally MAT for OUD among these individuals is critica lly important. Doing so can save lives and reduce future public safety and public health costs associated with unchecked opioid addiction among these individuals. 37. The Commission recommends the ational Institute on Corrections (NlC), the Bureau of Justice Assistance (BJA), the Substance Abuse and Mental Health Services Administration (SAMHSA), and other nationaJ, state, local, and tribal stakeholders use medication-assi ted treatment (MAT) with pre-trial detainee and continuing treatment upon release. Drug Courts and Diversion Programs There is evidence that a large majority of individuals who have an SUD do not receive treatment. 22 Drug courts are a proven avenue to treatment for individuals who commit non-violent crimes because of their SUD. Drug courts have traditionally been a more effective response for nonviolent, low-level offenders with SUDs, rather than lengthy prison sentences. A systematic review of drug courts in 30 states published by the Campbell Collaboration in 20 12 found that a combination of comprehensive services and individualized care is an effective way to treat offenders with serious addictions . However , 44% of U.S. counties in 2014 did not have a drug court for adults. 229 The princ ipal factors limiting drug court expansion are insufficient funding , treatment , and superv ision resources , not a lack of judicial interest. The Commission heard from several organizations. including Advocates for Opioid Recovery , tbe Addiction Policy Forum , and Young People in Recovery , about the need to implement and oversee these problem- olving courts to create tme ' recovery ready communities.' The U.S. Pretrial Diversion Program diverts certain inctividuals involved in the justice system for a first or second felony offence to a program of supervisio n and services administered by the U.S . Pretrial or Probation Services. The U.S. Attorney 's Office has the discretion to offer this alternati e to eligible indiv iduals. Under the program , diversion typically takes place before charging , although it is possible at any time before trial when a pretrial diversion agreement is executed . The period of supervision is up to 18 months . Drug-, reentry , or veterans' courts can be a central component of the pretrial diversion process . As ofJune 2015, the National Institute of Justice reported that there were 27 Federal District Courts that operated as drug courts as well as six federal veterans ' courts. Genera11y, Federal District Courts adopting the drug court model or simi lar approaches for diversion and/or reentry support are designated as Federal Reentry Court s. These courts can encompass pre- and post-adjudication diversion as well as post-incarceration reentry /recovery support . Federal reentry courts concurrently engage probation , parole , the Federa l Public Defenders , and U.S. Attorneys' Offices. They utilize a blend of treatment and sanction alternatives to address beha vior, rehabilitation and community re-integration for non-violen t, offenders who are seeking recovery from SUD. As a rule, Federal Reenny Courts make MAT a ailable to individuals participating in pre- and post-adjudication diversion and post-incarceration reentry programs . Studies have shown that MAT recipients remain engaged in treatment at higher rates , have fewer positive tests for illicit drugs , and reoffend at lower rates than individuals with OUD not receiv ing MAT . For incarcerated fAPGl ONDCP006FY18004 _000000046 ONDCP-18-0107-A-000076 individuals these courts typically incorporate an early-discharge program to replace the final year of incarceration with strictly-supervised release into the drug cowt regimen. Federal Reenhy Courts adopting the drug court model incorporate the 'Ten Key Components ' of a drug court program in a voluntary contractual program lasting a minimum of 12-18 months. Court program participants renuning to the community from incai-ceration are transferred to traditional parole supervision following graduation. However , they may continue to receive case management services voluntarily through the reentry court. Jurisdictions that rw1 drug courts continue to innovate and adjust their programs and policies based on experience and in light of the current opioid epidemic. In Buffalo , NY, the court fow 1d that some arrestees were suffering fatal overdose between arrest and their fot1n al entl)' into drug court. Therefore , they established the first Opiate Intervention ourt in the country. This court temporarily suspends adjudication of charges in order to get those at high risk of overdose into treatment. The program is relatively new , but the initial results are promising and other jurisdictions shou ld consider adopting a similar strategy . 38. The Commission recommend s DOJ broadly estab1ish federal drug courts within the federal district court system in all 93 federal judicial districts. States. local units of government, and Indian tribal governments should apply for drug court grants established by 34 U.S .C. § 10611. Individuals with an SUD who violate probation terms with substance use should be diverted into drug court. rather than prison. Add ict ion Servic es W ork fo rce and Train ing Needs By the year 2025 , workforce projections estimate that there will be a workforce shmtage in the fields of substance abuse and mental health treatment of approximately 250 ,000 providers across all disciplines. Workforce needs include addiction psychiatrists , physicians spec ializing in addiction medicine, counselors , recovery coaches , and other behavioral health providers. There are simply too few physicians and other clinicians with the requisite training to meet the demands of the estimated 19.4 million Americans suffering from untreated SU Os. Expanding the workforce to meet treatment demand will require a comprehensive federal , state , local public and private effort to develop the workforce pipeline_ Opioid-related inpat ient stays and ED visits have increased dramatically across the Nation. 230 Fowteen of tbe 18 states experiencing the bigbest rate of opioid overdose deaths have experienced an increase in opio id-re lated hospital admissions , ranging from 2 l .4% to 54.6%. Moreover, a recent analysis of private insurance data found that most privately insured patients do not receive recommended care following an opioid-related hospitalization. 23 1 Hospital programs are emerging across the country to address these surges in overdoses and improve post -discharge outcomes. One method has been the use of peer recovery coaches and other types of community health workers ( HWs) , such as health educators , medica l assistants , and community health outreach workers . The American Public Health Association defines a CHW as a ''frontline public health worker who is a trusted member of and /or has an unusually close understanding of the community served ." These workers are increasing ly employed in physician offices and other health settings as care extenders. As such. they are unique ly positioned to be trained to provide substance use screening , br.ief intervention, refeffal management , and health and IAPGl ONDCP006FY18004_000000046 ONDCP-18-0107-A-000077 community linkages in prima,y care aud emergency room settings, and to provide outreach and care to substance using homeless populations. Peer recovery specia lists/coaches are in recovery from an SUD. New programs are emerging across the countty to use CHWs and recovery coaches in a range of settings , including hospitals , to provide immediate and ongoing support and treatment linkages to individuals who have overdosed from opioids , or support individuals newly in recovery . These programs can address alarming levels of readmissions due to overdose. In addition, recovery workers are supporting law enforcement , fire departments, and other comm unity partners addressing the opioid overdose epide mic. The use of these types of care extenders can help address the workforce shortage , but more of them are needed. Recovery coaches are often members of a recove1y community organization (RCO) , which can and do play unique rolls in helping individuals, families and communities respond to drug use, addiction , and their consequences ; they are uniquely positioned to facilitate access to treatment , support retention and successful treatment comple tion, and provide ongoing services and support after treatment. Unfortunately , they exist in far too few communitie s. While states such as Ven11ont and Texas have developed and are e:x"J)andingand enhancing statewide RCO networks , other states have no RCOs at all or only have RCOs in selected commllnities. RCOs play a critical role in engaging individua ls addicted to opioids and other drugs , linking them to treatment and other needed services and supportin g them as they pursue their recovery . Integra l in tackling this epidemic is the recognition that diverse comm unities experience different rates of mental disorders and/or SUDs, as well as challenges to treatment access. For example , in 2016 , the rate of illicit drug use in the last 30 days among American Indians and Alaska Natives ages l2 and up was 15. 7%, the highest among all racial demography. 2 J 2 Research has shown that inte6,rating culturally-based solutions into evidence~based treatment and recovery programs is a best practice and improves treatment outcomes. RCOs are best positioned to develop and implement culturally-specific ways to address the crisis in their commun ities. RCOs are innovators and collaborators , working with hospitals , treatment providers , law enforcement , courts, corrections , child welfare systems , and broader commun ities to reduce drug use, and helping people achieve and sustain recovery. Their flexibility allows them to rapidly adapt to changing circumstances and to identify and fill gaps in systems and services. To maximize the benefit accrned from RCOs, federal efforts shou ld help better integrate RCOs into local and statewide systems, services and sectors , such as Drug-Free Communities , HIDTA, correctio na l systems , law enforcement , hospitals , primary care, specialty treatment, and child welfare. DOL has establ ished an apprenticeship program for CHW s and recovery coac hes with standard competencies , a curricu lum, educatio nal training , and on-the-job learning components, and routine ly provides grants to augment the workforce. Through this program , employers provide a stipend for entty-level CHWs to receive on-the-job learning , on-site supervis ion, and educational training with the intent to secure employment as a credentialed CHW. Once an apprentice completes the CHW ce,tificatio n program, his or her name is registered into a DOL databa se, issued a ce11ificate of completion, and is considered certified. The Presidential Executive Order Expanding Apprenticeships in America published on June 15, 2017 encourages federa l agencies to fund and provide other supports to expand the use of CHWs to provide critically needed services across the country. 233 Health entit ies such as hospitals and primary care offices can also sponsor training and employment. JAPGl ON DCP006FY 18004 _ 000000046 ONDCP-18-0107-A-000078 39. The Commission recommends the Federa l Government partner with appropriate hospital and recovery organizations to expand the use of recovery coaches, especially in hard-hit areas. Insurance companies, federal health s stems, and state payers should expand programs for hospital and primary case-based SUD treatment and referral services. Recovery coach programs have been extraordinarily effective in states that have them to help direct patients in crisis to appropriate treatment. Addiction and recovery specialists can also work with patients through technology and telemedicine, to expand their reach to underserved areas. Estimates suggest there are currently about 4 400 actively practicing cenified addiction specialist physicians (addiction medicine and addiction psychiatry) in the cow1try, but data on the specialty workforce is limited. About 8 years ago, an estimate was made of the need for 6,000 addiction specialists , but that number is uow insufficient given the growth of the opioid epidemic. Addiction medicine was only fonnally recognized as a medical subspecialty in 2016. Currently 46 of the Nation ' s 160 accredited medical schools offer addiction medicine fellowships. The firstever addiction medicine board exam was held in September 2017 . By 202 l , fellowships will be the only pathway for physicians to take tl1e addiction medicine certification exam. Without an adequate number of fellowships producing at least two new fellows per year the field will quickly atrophy. Therefore , it is important to quickly ramp up the numbers of fellowships to address the opioid crisis . The goal is to grow the fellowships to 125 over the next five years. Significant funding is needed to start and sustain fellowship programs. The Health Resources and Services Administration (HRSA) provides unique vehicles for addressing the increasing trends in opioid use, overdose , and addictions across the United States_ The agency funds health centers in urban, suburban , and rural areas , trains and strengthens the workforce, hosts the Federal Office of Rural Health Policy, and has grant programs for several high-need and underserved communities and populations . The 2p t Century Cures Act included funding for HRSA for addiction medicine fellowships starting in 2018 . Starting this year , fellowships will be accredited by the Accreditation Council for Graduate Medical Education, whicb is a significant step toward getting funding from the VA and others. Federal agenetes should also be considering where telemedicine can play a role in ensuring access to care for those in geographically isolated regions and underserved areas . 40. The Commission recommends the Health Resources and Services Administration (HRSA) prioritize addiction treatment knowledge across all health disciplines. Adequate resources are needed to recruit and increase the number of addiction-trained psychiatrists and other physicians, nurses, psychologists, social workers, physician assistants, and community health workers and facilitate deployment in needed regions and facilities. 41. The Commission recommends that federal agencies revise reimbursement policies to allow for SUD treatment via telemedicine. regulations and 42. The Commission recommends further use of the National Health Service Corp to supp ly needed health care workers to states and localities with higher tbao average opioid use and abuse. IAPGl ONDCP006FY18004_000000046 ONDCP-18-0107-A-000079 Responseto Overdose ExpandedAccess and Administration of Naloxone Naloxo ne is an opioid antagon ist medication that can rapid ly reverse opioid over dose. It Jias been available for over forty years , has an excellent safety profile , and can be easily administered by either intravenous or subcutan eous injection or via nasal absorption . In the interim report, the Commission recognize d the im portance of ensuring naloxone is made as widely available as po ssible to save lives. Consequent ly, the Commission recomme nded that all law enforcement in the United States be equipped w itb naloxone , model legislation be provided to states to allow naloxone dispensing via standing orders , and ' Good Samaritan ' laws be enacted to empower the public to seek help (Appendix 3). The Com.mission assesse d the availabilit y and accessibi lity of naloxone across the nation. Fignre 5 below shows the means at wh ich the public can access naloxone in communi ty pharmacies widely differs betwee n the states. Whil e there is not necessarily a naloxone supp ly shortage, price increases of the various form s of naloxone continue to create affordability issues, preventing state and local gove rnments, as well as commun ity organ izations, from stocki ng na loxone at the leve ls necessary to rescue more peopl e from overdose. Naloxone Accessin Community Pharmacies Baseden da!a cclrded ..., NASPA(l.l)dat,,d line 201?) HI Sta1owldo Protocol/PI\Jrmac lst Pnscrlblng St~!ewlde St.lndlng Oldor Otspense without a pre,sc11pt1on Standing Order None Fig ure 5. Naloxone Access (Source: National Alliance of State Pha1m acy Associations) To further ensure nalo xone is made avai lable when there is the greates t chance of an overdose, we must allow more first respo nders to be equ ipped w ith this life sav ing drug, including E MS personnel. In 2007 , the Nation al Highway Traffic Safety Administration 's (NHTSA) issued its [APG] ONDCP006FY18004_000000046 ONDCP-18-0107-A-000080 National EMS Scop e of Practice Mod el to provide guidance to states on the minimum skills and knowledge for licensure of each of four levels of EMS personnel· these four levels are : • • • • Emergency Medical Responder (EMR) Emergency Medical Technician (EMT Advanced Emergency Medical Technician Paramedic The Model suggests that the first two level -EMR and EMT- not be approved for the administration of naloxone . Currently several states, followiog the NHTSA guidelines , prohibit EMRs and EMTs from administering naJoxooe in cases of opioid overdose. With the onset of the cunent opioid crisis , this prohibition has become problematic , especially in rural areas where the higher two levels- Advanced Emergency Medical Technician and Paramedic - are less common than in urban or suburban areas . Additional'ly, even in urban and suburban areas EMS personnel in the two lower levels may be the first responders to incidents of opioid overdose. Given the critically narrow window that exists in which to administer na1oxone to prevent overdose death, there may not be time to await arrival of higher level EMS personnel. The Model has clearly become outdated with regard to its guidance 011 the ability to administer naloxone by EMS personnel in the two lower Jicensure levels, especially given the low risk of adv erse effects of administering naloxone in either opioid o erdose on non-opioid overdose conditions and the development of easily administered , pre-measured dose technologies. Funhermore , in N ew Jersey , Commission Chair Governor Christie recently directed his Administration to revise EMS guidelines to allow for higher doses of intranasal naloxone to be administered , as the initial guidelines allowed for 2 mg of naloxone , which proved insuffi.c-ientfor some of the stronger opioids like synthetic fentanyL 43. The Commission recommends the Natio nal Highway Traffic Safety Administration (NHTSA) review its National Emergency MedicaJ Services (EMS) Scope of Practice Model with respect to naloxone. and wsseminate best practices for states that may need statutory or regulatory changes to allow Emergency Medical Technkians (EMT) to administer naJoxooe, including higher doses to account for the rising number offentanyJ overdoses. Combination opioid product s, especially those co-formulated with naloxon e {e.g., o ycodone /naloxone and or buprenorphine /naloxone) have been associated with lower rates of misuse and nonmedical use compared with their single-entity counterparts .234 ·235 rn the interim report (Appendi x 3), the Commission recom mended a require ment that naloxone be prescribed in combinatio n with any CDC -defined high-risk opioid being prescribed . Initial studies of the coprescrib ing of naloxone with high morp hine equi alent narcotic analgesics suggest that coprescribing can reduce use and abuse of prescription opioids . The results from a 2016 study found a 4 7% reduction in opioid -related overdoses in the first ix mon ths after receipt of the prescription .236 [nitial best practice guidance should be prov ided based on current ly availab le data and further . a federally-funded pilot project should be developed to confirm initial findings and clarify the most effective strategies related to co-prescri bing. IAPGl ONDCP006FY18004 _000000046 ONDCP-18-0107-A-000081 44. The Comm ission recommends AHS impl ement naloxone co-pres cribing pilot programs to confirm initial researc h and identify best practices. ONDCP should , in coordination with HHS, disse minate a summ ary of existing resea rch on co-prescribing to stake holders. Overdose to Treatment and Recovery Effective ly linking individt 1als who ha e survived an opioid overdose and those at risk for overdose remai ns a challenge . However , several promis ing approaches are emerging. These include , but are not limited to : • Buprenorph ine induction in the ED or other hospital department s followed by linkage with primary care and psychosocial services ; • Methadone induction for hospi talized patients followed by direct linkage to an opioid treatment program (OTP) : • An opioid urgent care unit adjacent to an ED that provides care coordinatiot1 and linkage to office-based opioid treatment and psychosocial services ; • Overdose prevention training and nalo one distribution in the ED and other hospital settings ; • Post-overdose ED-based engageme nt, service linkage , and ongoing support and service coordination by recovery coac hes and other peer workers who are on-cal I 24 hours per day , 365 days per year • Co-locatio n ofreco very coaches and other peer recovery support services workers at opioid treatment programs and primary care practices providing buprenorpb.ine for the treatment ofOUD ; • Community outreach and engagement of opioid users , their friends and family by recovery coaches and other peer workers ; and , • Specialty bedside care for hospitalized patients from an inpatient addiction consu lt team . Io hospital setting s, immediate engagement and initiat ion of treatment with an FDA -approved medication and/or recovery suppor t services while the patient is still in the ED or is still in an inpatient hospital setting is critically important to increasing the number of Americans with opioid addictioo who access treatment , decreasing overdose rates and related fatalities , and gradually lessening the burden the opioid crisis is creating for first responders , hospitals , and commw1ities as a whole. To increase treatment participa tion, retention , and impro ve long-term. recovery outcomes , a combination of clinica l and recovery support services is necessary . EMT ALA requires EDs to stabilize and treat emergency medical conditions regardless of the pat ient s abi lity to pay. Med ical stabil ization language exists in other regu lations a.s well. The general stabi Iizatjon requfremeut is to resolve acute symptoms to avoid serious jeopardy to patie nt health . In the case of an indi idual with an OUD who has been revived after an overdose , initiation of MAT is often r equired to stabi lize the patient prior to discharge. In addition , appropriate "health exten ders," such as CHWs and recovery coaches , are also required to provide treatment engagemen t and follow-up services . Many emergency rooms ru1d hospitals do not have snfficiently trained staff to diagnose ru1OUD or to provide the range of MAT and psychosocia l services that IAPGl ONDCP006FY18004_000000046 ONDCP-18-0107-A-000082 are needed to stabilize individuals. Thus, many overdose patients are being released without being appropriately stabilized and are at very high risk for sub equent overdose readmissions. 45. The Commission recommends HHS develop new guidance for Emergency Medical Treatment and Labor Act (EMTALA) compliaoce wjtb regard to treating and stabilizing SUD patients and provide resources to incentivize hospitals to hire appropriate staff for their emergency rooms. Recovery Support Services Over the past decade. or more , recovery has re-emerged as a key area of policy , practice , and advocacy. Recovery bas many definitions. SAMHSA defines recovery from mental and SUDs as a process of change through which individuals improve tbelr health and wellness , live a selfdirected life, and strive to reach their full potential. Reco ery support services (RSS) are nonclinical services designed to help individuals navigate the early stages of recovery and achieve stable , long-term recovery. Several organizations and programs exist to prov ide a stmctured and supportive environment for people in long-term recovery and are an emerg ing infrastructure with approximately I00 national organizations . However , national standards delineating the essential components . as well as financing and operation of state and local RSS, do not exist. Tbe RecoveryOriented Systems of Care framework identifies relevant values , principles , and strategies . lt can be used as a starting point for development of standar ds. While national peer RSS organizational accreditation standards have been developed and implemented by th.e Council on Accreditation of Peer Recovery Support Services and national peer recovery supp01i services specialist certifications have been developed by the two largest certification bodies in the addictions arena , states have not uniformly adopted these standards. Similarly , while the National Alliance for Recovery Residences has developed recovery housing certification standards that recognize levels of recove1y housing , ranging from homes leased and operated by the residents (e.g., Ox.ford Houses) to residences with linked to clinical service , substandard recovery housing/sober living homes remains a problem in many jurisdictions . 46. The Commission recommends that HHS implement guidelines and reimbursement policies for Recovery Support Services including peer-to-peer programs , jobs and life skilJs trafoing, supportive housing, and recovery housing. Impact on Families and Children Addiction impacts each member of a family, affecting each member differently , but the most vulnerable are children. Children whose parents ha e an OUD may be neglected or even require removal to foster care. The developing fetus is vulnerable to substance use by the pregnant mother , as drugs readily cross the placenta and enters fetal blood circulation . The opioid epidemic has jmpacted many states with increases in the number of children who have entered foster care due to parental drug use. Child welfare agencies have seen an increase in their IAPGl ONDCP006FY18004 _000000046 ONDCP-18-0107-A-000083 caseloads and are burdened with limited resources , e.g., funds to support drug treatment or parenting classes and con1Jnw1ity-based support for these children. Stakeholders in the child welfare arena must collaborate to identify best practices to support families and intervene sooner . Successfu l treatment for parent s can take multiple attempts and requires varied support from many agencies and community-based groups (e.g ., treatment providers , counseling , supportive housing , drug courts , parenting classes , and transportation ). Once a child enters foster care the time frame for reunifica6on with their parents or the termination of their parental rights begins. Whjle this varies state by state due to the scope of the problem it is Clitical that social workers and child protection staff are equipped to identify substa nce use early. In New Jersey , Commission Chair Governor Chr istie announced in September 2017 that the state ' s Department for Children and Fami lies would be addressing these issues in a multi-prong approach ; tra ining Child Protection workers in SUDs, creating a program of peer -support for parents involved with the cbjld welfare system , and increasing the investment in supportive house (" Keeping Fami lies Together " program) for families in olved in the child welfare system that experience parentaJ SUD and housing instability . Children who are in foster care are at greater risk for mental health problems poor physical health, experience more adverse family experiences and more likely to be suspended from school. 237 1he number of children experienc ing AS increased 383 % during the period 2000-201 2 ( 1.2 cases To address the number per I 000 hospital births in 2000 to 5.8 cases per hospital births in 2012) _;1'.ls of children born with NAS, the passage of the Comprehensi e Addiction and Recovery Act (CARA) of 2017 has modified state requirements related to how states must address SUDs , NAS and Fetal Alcohol Syndrome . Section 503 of CARA recommends that state.s implement a plan of safe care, yet the requirement does not identify a lead agency to oversee and ensu re its implementation which continues to ensure a gap in leadership on this issue. 47. The Commission recommends that HHS, the Substance Abuse and Mental Health Services Admfois-tration (SAMHSA), and the Administration on Children, Youth and Families (ACYF) should disseminate best practices for states regarding interventions and strategies to keep families together when it can be done safely (e.g., using a relati ve for kinship care). These practices should include utilizing comprehensive family centered approaches and should ensure famiJies have access to drug .sc.reening, substance use treatm ent, and parental support. Further, federal agencie s should research promising models for pregnant and post-partum women with SUDs a.nd their newborn s including screenings treatment inte rventions , supportive housing , non-pharmacologic interventio ns for children born with neonatal abstinence syndrome, medication-assisted treatment (MAT) and other recovery supports. Support ing Collegiate Recovery and Changing the Culture on College Camp uses When American parents send their high schoo l graduates to college , often at huge financial sacrifice , they hope to launch their children in -pursuit of their merican dream. Unfortunately , too many students get caught up in drug use and binge drinking , putting both their health academic, extracurricular , and future prospects at risk . Many of these young people are unable to complete their studies . When they do achieve recovery , they are faced with the challenge of returning to tbe lion 's den- a college or university campus where alcohol misuse and drug use may be the nonn [APGl ONDCP006FY1800 4_000000046 ONDCP-18-0107-A-000084 for large portions of the student body. 1t is not surprising that researches have characterized higher education campuses as "abstinence-hostile environments. " As more young people find reco e1y in their teens , they and their parents face the similar challenge of identifying a college or university that will not put their recovery at risk . ln face of this a growing number of colleges and tmiversities have established collegiate recove1y programs (CRP). These programs offer support and assistance to students in recovery and to students seeking help for alcohol and other drug problems . To join , some RP's require treatment completion and/or a specified period of abstinence coupled with mutual aid participation while others are open to any student who believes they have an alcohol or other drug problem or who simply wishes to be part of a community for which alcohol or other drug consumption is not a part of social and recreational activities. Some RPs provide a dedicated dorm or recovery residence for members and others do not. Rutgers University , New Jersey's flagship state university system has the longest-running CRP in the nation. The Rutgers CRP began in 1983, with dedicated housing added in 1988. For the student residents , the program provides recovery support, a substance-free Jiving environment , and a variety of extrac-urricular and enrichment activities SllChas outings and intramural sports. Students are expected to attend two 12-step meetings each week , and meetings are offered on campus. Rutgers staff regularly provide s assistance to colleges and universit-ies around the country who are looking to create or improve programs on their campuses . To further these programs , New Jersey has passed legislation requiring all state colleges and univers-ities with a signjficant portion of students living on-campus to have dedicated substancefree housing for sn1dents who wish to live in a substance.free environment. CRPs are relatively small and inexpensive, and provide significant benefits to schools by encouraging degree completion, reducing drop outs, and promoting the health and safety of students. Programs vary, but they commonly include the following components: a coordinator or executive director and small staff ; student volunteers· a gathering place , such as a recovery lounge for students to drop by and support each other and for events; academic advice for those seeking to retnm to or stay in school; scholarships for those in need who are in recoveiy and maintain good grades; sponsorship of drug and alcohol free events open to all students on campus ; leader ship , professional development , and other opportunities to speak out about effective solutions to drueand alcohol problems . In addition to helping students in recovery flourish and succeed academically , CRPs offer an attracti ve campus community for sh1dents who are not in recove1y, but wish to avoid alcohol and other drugs. Through their alcohol- and other drug-free events , including football game tailgates and parties , movies , restaurants, music and theater outings , they offer safer and healthier alternative not only for members , but for a range of other students . While the number of collegiate recovery programs has grown significantly over the past decade , it has been estimated that only 3% of higher education instimtions in the United States currently have a RP.239 Although most of the costs associated with CRPs should be financed by the colleges themselves, governmen t agencies can take some modest steps to accelerate adoption of these prograrus , as l1ighlighted below_ 48. The Commission recommends ONDCP, the Substance Abuse and Mental Health ervices Administration (SAMHSA), and the Department of Education (DOE) identify successful IAPGl ONDCP006FY18004 _000000046 ONDCP-18-0107-A-000085 college recovery programs, including "sober housing" on college campuses, and provide support and technical assistance to increase the number and capacity of high-quality programs to help students in recovery. Employment Opportunities for Americans in Recovery Americans who are in stable recovery from addiction deserve fair consideration for any job for which they are qualified. There are millions of Americans in recovery from all walks of life . Many of these individuals have past misdemeanor or felony drug-related criminal convictions that can impede or prevent them from securing employment for which they are quaJifiecl even after having paid their debt to society and having achieved decades in recovery . When this occurs , it is not only those individuals who pay a price ; their families and communities can be deprived of contribur-ions these Americans might otherwise have been able to make . Laws and rules that impede or prevent employment for people in recovery can be counterproductive making it more difficult to fuJ[y rejoin the community and sustain a life in recovery . In addition to the barriers created b y having a pa t criminal conviction , those in recovery can face long-lasting barriers to employment due to laws that prohibit the hir ing of individuals with a past drng conviction in certain settings. For example , Section 1128 of the SociaJ Security Act prohibits any entity receiving funding under federal health programs , such as Medicaid , Medicare , CHIP , TRICARE , or the VA , to employ individuals who have past felony convictions "relating to the unlawful manufacture distribution prescription , or dispensing of a controlled substance " (unless that conviction was related to au act that took place before the enactment of the Health Jusurauce Portability and Accountability Act of 1996) [42 U.S .C. 1320a,-7 (4)]. This ban includes individuals with felony convictions related to the sale of illicit drug s outside of the context of a healtb care facility and co vers not only healtJJ professionals , but all categories of staff , including custodians , drivers , admin i strative support staff , building engineers , mail room personnel , etc . Known as collateral consequences of conviction , laws of this kind apply restrictions to individuals that continue after t11eyhave completed their sentences . These laws can be found at tbe federal , state , and local le els . Collateral consequences of conviction can serve an important public safety function . However , to the extent that they impede successful recovery or reentry from incarceration without contributing significantly to public safety , tbey have the potential to actually undermine public safety , public health , and drug control policy goals. Under an award from DOJ the American Bar Association created a publicly a ailable comprehensive searchable onli.ne database cataloguing over 45,000 collateral consequences and civil disabilities and ident ifying remedies in instances where they are available. 240 ,24 1 Ultimately, pri vate sector employers are well positioned to play a central role in supporting the hiring and ongoing employment of those in recovery , identifying mies and laws that may impede hiring people in recovery , and increasing treatment access for employees with active addiction. Employment for tho se with past drug use is a critical part of the solution to this drug crisis. The State of Florida has decoupled felony convictions and eligibility for certain business or occupational Iicenses with great success , expanding access to the wide arrays of jobs with licensing requirements. IAPGl ONDCP006FY18004 _000000046 ONDCP-18-0107-A-000086 49. The Commission recommends that O DCP, federal partners, including DOL, large employers, employee assistance programs, and recovery support organizations develop best practices on SUDs and the workplace. Employers need information for addressing employee alcohol and drug use, ensure that employees are able to seek help for SUDs through employee assistance programs or other means, supporting health and wellness including SUD recovery, for employees, and hiring those in reconry. 50. The Commission recommends that ONDCP work with the DOJ DOL, the National Alliance for Model State Drug Laws, the National Conference of State Legislatures, and other stakeholders to develop model state legislation/regulation for states to decouple felony convictions and eligibility for business/occupational licenses, where appropriate. Support Recovery Hous ing There is a critical shortage of recovery housing for Americans in or pursuing recovery . Reco ery residences (also known as "sober homes " or "recovery homes ") are alcohol- and drug-fr ee Living environments for individuals seeking the skills and social supp011to remain free of alcohol or other drugs and live a life of recovery in the community. GeneralJy, recovery residences do not offeJ treatment , although some are affiliated with , or are arms of treatment provider organizations that offer counseling or other services to residents onsite or at a nearby location . Recovery residences strongly encourage attendance at 12-step groups or other mutual aid groups (e .g., SMART Recovery , Women for Sobriety , Celebrate Recovery , etc.) and are generaUy self-funded through resident fees, or in the case of Oxford Houses or other resident-nm homes , shared rent , utility , and food payments. Benefits associated with staying in a recovery residence include decrease s in alcohol and drng use, psychiatric symptoms , and arrests as well as increases in employment. 242 Recovery residences can play a critical role for individuals in outpatient treatment , those exiting residential treatment, homeless individuals in early recovery , those involved in drug courts , those returning to the community from incarceration , and those who may not require residential treatment .if they have a living environment that is supportive of recovery , outpatient treatment and/or mutual aid groups. Many who cannot return to a home where there is active drug use or a community where tbey used drugs find a safe haven in a recovery residence. lmportaatJy , like peer RSS generally , recovery residences can help maximize the public and private investments in treatment by ensuring better long-term outcomes , by sometimes making a lower, less costly level of care possible and, in some instances , by making treatment unnecessary . Unfortunately , unethical operators have cast suspicion on recovery residences generally and ha e complicated the efforts of families , treannent centers , and court systems to identify safe, supportive , well ruu, and affordable recovery hou ing. Quality recovery residences operate in accordance with accepted national guidelines , such as the standards developed by the National Alliance for Recovery Residents (NARR) or the charter Oxford Houses must follow. Residences tbat do not meet these or state-established standards can place those they serve at risk Wbile some states have defined recovery residence licensing criteria and or required their treatment providers to only refer patients to certified recovery residences and Oxford Homes , many have no mechanism for enswing quality and accountability . 51. The Commission recommends that ONDCP, federal agencies, the National Alliance for Recovery Residents (NARR), the National Association of State Alcohol and Drug Abuse fAPGl ONDCP006FY18004 _000000046 ONDCP-18-0107-A-000087 Directors (NASADAD) , and housing stakeho1ders should work collaboratively to deve1op quality standards a.nd best practices for recover y residences , including model state and local policies. These partners should identify barriers (such as zoning restrictions and discrimination against MAT patients) and develop strategies to address these issues. IAPGl ONDCP006FY18004 _000000046 ONDCP-18-0107-A-000088 Research & Developme nt For too long addiction and pain research have been conducted and led by separate research communities and suffered from silos and in some cases excessi e pressure from industry at the cost of patient health. The National Drug Control trategy has never included a pain managem,eot emphasis despite the fact that prescription opioid misuse still is responsible for most opioid misuse in th.is country and providing better pain management is essential to preventing prescription opioid misuse and diversion that starts so many people down the path to heroin use. Severa l federal agencies are best suited for shepherding research initiatives and opportunities to combat the epidemic 243 and enhance freatment options , including alternative pain management shategies , and treatment for vulnerable popu1ations such as pregnant women , and substance-exposed infants . Addressing the gaps with basic, applied research, and development can conceivably expand the range of alternatives to imperfect medications currentl y used to mitigate pain or treat addiction . 52. The Commission recommends federaJ agendes , iocJuding HHS (National Institutes of Health, CDC, CMS. FDA, and the Substance Abuse and Mental Health Services Administration) 0OJ , the Department of Defense (000), the VA, and ONDC:P, should engage in a comprehensive review of existing research programs and establish goals for pain management and addiction research (both prevention and treatment). New Pain, Overdose, and MAT Medications The bounties of scientific research are essential to mitigate the opioid crisis , drug addiction and associated morbidity and mortal ity. The most practical ba ic research goals for the current epidemic 244 are to develop: (l) effective analgesics with limited or no abuse liability , i_e_ alternatives to opioids ; (2) drugs to reverse overdose capable of surmounting newly emerging fentanyl analogs or new psychoactive opioids; and (3) medications that do not engender abuse liability or physical dependence to assist in treating opioid addiction . Each of these areas requires short- , intermediate -, and long-term research strategies . The research goals have been charted and led by the NIDA Director , with support and coorcLinationamong the N Ill -institutes and the NIH Director. NIH has also recrnited pbannace utical companies to develop public-pr ivate partnerships in pursuit of these goals. This initiative offers great promise to improve tbe range of choices for pain management , medications assistance and o erdose reversal. As an example , a NIDA partnership with a pharmaceu1ical company successf ully developed a user-friendly intranasal naloxone formulation that results in blood naloxone leveJs equivalent to those reached with injection. The FDA approved it in 2015. Alter,wtives to Opioill Pain Medict1tions. µ-opioid signaling is among the most effective system to dampen or block pain. The same system also produces pleasurable sensations , even euphoria which drives addictive behaviors. For over a century , medicinal chemists have pursued safer opioids to discmmect pain relief from pleasurable sensations. Opioid over-prescribing in part reflects the limited num ber of effective medications to treat moderate to severe pain and the compelling need for alternatives. Among the candidate solutions are development of abusedetenent fonnulations , new opioids that trigger ''biased' µ-signaling pathways , or target other opioid receptors subtypes , or drugs that modify other receptors , and ion channels involved in IAPGl ONDCP006FY18004 _000000046 ONDCP-18-0107-A-000089 processing or modifying pain sensations , includine transient receptor potential vanilloid (TRPV) channels , non-psychoactive cannabinoids , inflammatory pathways , or other modifiers of signaling pathways. Novel therapeutics are also likely to emerge from a better ltnderstanding of pain biology , enabled in part by transfonnative technologies such as the ability to solve tbe three-dimensional crystal structure of target proteins o.r assess pharmacology by computer simuJa6ons _Adoption of other transfonnative technologies , incJuding induced stem cells and CRISPR, can result in more efficient validation of novel compounds through the development of models with better translational fidelity . Clinical studies can also be improved by patient selection and stratification .245 Over,lose Reverst1Il11terve11tiom ·. Over 140 Americans die daily from opioid overdoses_ The primary reason is that overactivated µ~opioid receptors in brainstem netuons stop natural breathing_ Naloxone targets the µ-opioid receptor , but unlike oxycodone heroin , or fentanyl , ·instead of activating it, it prevents it from functioning and re.verses and overdose, if administered in sufficient time. It has saved thousands of Ii es, but is ineffective if the person overdosing is alone during a narrow window of time , or ifTequiring multi.pl~ doses to surmount a highly potent opioid .246 This new challenge is reflected in the rapid rise in overdose fatalities driven by the highly potent drug fentanyl , or even more potent fentany] analogs . Prtvate partnerships are engaging with NIH to develop higher affinity longer-acting formulations of anta gon ists, includjng naloxone , to cmmteract the very-high-potency synthetic opioids that are now cJaiming thousands of lives . Treatments for Opioid A,l,licti,m. Research and development are needed to improve the range of medications to assist in treating OUD. Cuffently three medications are approved for treating OUD: methadone , b11prenorpbine, and ER naltrexone_ Along with psychosoc ial support , they comprise the curre nt standard of care for reducing illicit opioid use, relapse risk , and overdoses , whjle improving social function .247 Each of these medications has important strengths. but some shortcomings. Methadone is fol.Iagonist at the ~t-opioid receptor , while buprenorphine is a partial agonist. Both methadone and buprenorphine can be reinforcin g and thereby diverted, unlike naltrexone which like naloxone, blocks the receptor. Compliance with treatment is higher with methadone than with buprenorphine or naltrexone ,248 but overall success in abstinence is imperfect. 249 There is a clear need to develop new treatment strategies for OUDs , including new pharmacologic approaches that focus on modulating activity of the reward circuit through othef targets (e_g. neurokinin-1 receptor antagonjsts or JC-opioid receptors antagonists) . Other target receptors andvaccines to prevent brain entry of opioids are under investigation.. Over a longer time-frame , prevention and treatment of opioid addiction will require more exquisite knowledge of tbe mechanisms w1derlying pain , reward, loss of control , and how biological and social factors shape the attractiveness of opioids . Treating chronic pain while avoiding misuse is problematic for patients with a prior history of SUD and more research conceivably will reveal the degree of risk for OUD when people with serious pain are unde rtreated. Other research voids include brain research imaging of people who overdose one or more times . Recent reports have documented cases of amnesia after an overdose . The extent to which opioids cause significant and possibly irreversible brain damage warrants investigation . 53. The Commission recommends Congress and the Federal Government provide additional resources to the ational Institute on Drug Abuse (NIDA) the National Institute of Mental Health (NIMH), and National Institute on Alcohol Abuse and Alcoholism (NIAAA) to fund the research areas cited above. NIDA should continue research in fAPGl ONDCP006FY18004 _000000046 ONDCP-18-0107-A-000090 concert with the pharmaceutical industry to develop and test innovative medications for SUDs and OUDs, including long-acting injectables. more potent opioid antagonists to reverse overdose, drugs used for detoxification and opioid vaccines. Medical Technology Devices Research ru1ddevelopment in new teclmoJogies/devices to assist in the opioid crisis are emerging. Their development should be encouraged. A few examples are offere d, with a caveat that few have received FDA approval , while others are in vatious stages of research ru1ddevelopment and ha e yet to undergo FDA scrntiny or even be sufficiently developed for cJinjcal trials. • Detection of real-time substance use is a critical step for optimizing behavioral interventions and feedback to prevent drug abuse. Traditional methods based on selfreporting or rapid res ult urine screening are inefficient or intrusi ve for dmg use detection , and inappropriate for timely interventions . Methods for real-time substance use detection are severely underdeveloped. A new rea l-time dmg ose event detection method is bei11g developed that uses data obtained from wearable biosensor. Biosensors are designed to detect and establish thresho lds of para.meters in a real-time drug use event and to produce wearable biosensor data streams .250 • Wearable devices that sense respiratory dep ression (rings, ear pieces that can alert the user, a family member or wireless ly report to a first responder to intervene , or automatically inject naloxone when blood oxygenation leve ls become da11gerouslylow. • Apps on electronic devices (phones , watches) that can function as behavioral coaches and reminders. • Technology devices that trru1smit findings from smartphones directly into the medical record_ • In home monitoring of vital signs with transmission capability • Transcranial magnetic stimulation (TMS) for treatment of pain. • Monitoring appropriate consumption/compliance with medications that contain a transmitter to relay a signal as soon as a drug enters the digestive system . A similar transmitter can be adapted for naloxone use . • Behavioral monitoring feedback apps that can be as, or more effective than face-to-face behavioral tra ining for addiction. • Pain reduction devices such as subcutaneous fie ld st imulators dorsal column stimu lator , dorsal root gang-lion stimulators , multifidus muscle stimu lators , implantable infusion pumps , and sensory cortex stimulators_ • Detection of dmg cons umption use (drugs/metabolites) in neighborhoods using a waste water collection system positioned in drain s within small regions (two block radius) to identify hot zones of clistribution and/or use . 54. The Commission recommends further research of Technology -Assisted Monitoring and Treatment for high-risk patients and SUD patients. CMS, FDA, and the United State IAPGl ONDCP006FY1800 4_000000046 ONDCP-18-0107-A-000091 Preventative Services Task Force (USPSTF) should implement a fast-track review process for any new evidence-based technology supporting SUD prevention and treatments. 55. The Commission recommends that commercial insurers and CMS fast-track creation of Healthcare Common Procedure Coding System {HCPCS) codes for FDA-approved technology-based treatments, digital interventions, and biomarker-based interventions. NIH should develop a means to evaluate behavior modification apps for effectiveness. FDA Post-Market Research and Surveillance Programs The FDA is a key federal agency designed to safeguard pubJic liealth and safety , including opioids .. Of all the drugs approved by the FDA, opioids are causing more illnesses and deaths than any other drug class currently 011 the market. FDA ' s time line of regulatory oversight of opioids from 191 I -onward shows a rapid expansion of approval of opioids starting in the mid- l 990 ' s and continuing to this day. In 200 l as concerns of addiction and overdoses emerged , the FDA took steps to develop public education regarding prescription drug abuse packet inserts for patient education , and stro nger warnings. Other discrete steps taken to rein in their adverse consequences proved equally ineffective. 25 1 In 2016 , the FDA once again initiated assessment and implementation of its policies to consnict unfettered prescribing practices. These policies included expanded use of advisory committees , development of warnings and safety information for IR opioid labeling , strengthening postmarketing requirements , updating the Risk Evaluation and Mitigation Strategy (REMS) Program that requires sponso rs to fund con tinuing medical education to providers , at low or no cost , on appropriate use of opioids expanding access to abuse-deterrent formulations to discourage abuse and reassessing the risk-benefit approval framework for opioid use .252 In 2017, the FDA brought IR opioids under its REMS program authorities , along with ER long-actin g opioids ; however prescriber education in this pro gram is currently optional for prescribers. Currently , more than 20 opioid analgesic formulations are approved by the FDA and an additional 52 applications for approval are being considered. 253 The evidence base to guide the use of opioid medications , particularly io the setting of long-term use , is substantially lackin g. Over decade s, opioids were approved by the FDA with two significaht gaps in vigilance : lack of concern of mi suse . tampering , and diversion from a legitimate prescriptio n and inadequate post-market surveillance of efficacy for long-term use, addiction and other long-tetm consequences e.g . depression or transition to heroin) . The FDA is strengthening the requirements for drug companies to generate post-market data on the long-term impact of using ER/long-acting opioids and accumulate better evidence on the serious risks of mistise and abuse associated with long-ter m use of opioids, predictors of opioid addiction, and other i.mpmtant issue s. 56. The Commission recommends that the FDA establish g1tidelines for post-market surveillance related to diversion addiction, and other adverse consequences of controlled substances. IAPGl ONDCP006FY18004 _000000046 ONDCP-18-0107-A-000092 Conclusion The origjns of the current opioid crjsis can be traced to a sequence of at least twelve converging events and movements that catalyzed the most devasta ting drug ep idemic in our nation 's history . A five-sentence letter to a biomed ical journal in 1980, followed by other low-quality articles claiming that opioid narcotics are safe to use uruversally for chronic pam , bolstered advocacy by pain patients and profes sional societies to treat pain with opioids. It also instigated the opioid pharmaceutical industry to embrace and exploit the flawed claims with aggressive marketing and "educational outreach. " Government agencies and accreditation organizations then designated pain as a ti fth vital sign. Without a counterbalancing force appearing in the med ical community to question the evidence or conclusions , pain assessment became a preoccupation of healthcare practices and opioid prescribing became an accepted solution. Prescriptions for opioids surged, now fueled by financial and performance pressures on physicians to satisfy patients using opioids, insurers ' tmrestrained reimbursements for opioids, an insufficient respon se of federal regulators, and lack of public unawarenes s of the hazards of this class of drugs. Poor medical education on pain management, on opioid prescribin g, and on screening for hlgb risk patients undermined the ability of conscientious physicians to safely treat pain or addiction. A nation awash with prescription opioids became fertile ground for diversion by acquisition from medicine cabinets, through rogue pharmacies , rogue physicians , and for opportunistic sellers of illicit heroin , fentanyl , and other deadly opioids. The Commission bas reflected on this history , for it is a compelling source for solutions to contain this national nightmare , solutions that are complex and multi -dimensional. By the very nature of our federal-state-local governance , most solutions require responses at all levels of gove rnment. Some need the cooperatio11and the support of private institutions, such as commercial insurers , companies engaged in data analytics , academic instimtions , or individuals who have inadvertently contributed to this crisis . Unintentional contri butors to the crisis are recognizing earlier misstep s and devis ing strategies to ' reverse engineer' decisions with prudence . The goals of the recommenda tions included in this report are to promote prevention of all drug use with effective education campaigns and restrictions in supply of illicit and misused drugs. To achieve supp ly reduction , we recommend shaping prescribing practices by improved medical education , by alternatives to pain management , as appropriate , by enhancing physician awareness of bigb risk patients though substance use, mental , and medi cal screenings and interrogation of PDMP s, insurnnce company oversight , and by illterdiction of deadly opioids. Treaunent and overdose rescue are both distinct and inextricably linked efforts. Overdose rescue procedure s need to be opportunistic and include access to trained personnel , to med ications, and to treatment services. Administering naloxone to a person wbo has overdosed and then abandoning them without offering medication and same-day entry to treatment is shon- sighted and inadequate . Treatrnent serv ices need to be improved, foremost by developing thoughtful national evidencebased standards of care, record-keepin g, and long-term support. In view of the need , expansion of services is imperati ve and so are surmounting barriers - to medicatio ns, limited healthcare workforce , to insurance reimbursement - and ens uring high-quality care and long-term recovery support services. The Commission strong ly supports research and development of alternatives to opioids for pain management , treatment and rescue , and of modern medical devices essen tial to improving our [APGl ON DCP006FY 18004 _ 000000046 ONDCP-18-0107-A-000093 respo nses. The Commi ss ion also stro ngly recommends real-tim e data analytics to inform ou r mission and accomplishments. Above all, each recomm endation should ha ve accoun tabilit y builtin and be subje cted to meas urable goa ls, quantita tive solutions, and m easu rable outcomes. The Federa l Government now must develop a level of accountability that has not been imposed rigorously in the past. Lesso ns le11n1e d. A catalog of lessons learned can guide our nation in devis ing current solutions and alerting future generation s on how to avoid inev itable emerging and potentially devasta ting dru g-related crises. Important lessons can be extracted from earlier imprud ence . Th e current focus on op io.ids is driven by tbe devastatingly high death rates. Wh iJe death is the ultima te catastrophe , man y psyc hoact ive dru gs with abuse pot ential do not precipitate an overdose crisis nor death as dram atically as do opioids. No netheless, other dru gs can be markedly detrim ental to the brain , body , and behavior. • Low qua lity evi dence that opioid s are innoc uou s for chronic pain m~rnagement was accep ted without scrutin y, by the healthca re syste m, by physi cians, med ical schoo ls, regulato1y bodies , and insurers. High-quality assessment of the addictive potential oforally bioavailab le opioids should have been imp osed by the FDA. • Constant vigilance is neces sruy to recognize if marketi ng efforts are suppr essing sc ienti fie evidence (e.g. addiction) and comm on sense. Early scientific scrutiny of dub ious claim s shou ld be a key priority of regulato ry agencies and physicians . • Engage all stakeholde rs wl1en creating standard s and actionable ou tcomes. Do not restr ict input to those who passionately favor a substance. Advocates may be. less willing or able to see unintended consequences than others. • The approval process of medications with abu se liabili ty shou ld not be restricted to drug safety and efficacy in short term clinica l trials. The dm g appro va l process should expand its oversight and cons ider the numb er of doses and dura tion of a prescription for spec ific indi cations, the possibi1ity of misuse , divers ion, and tamp ering, and other consequences not traditionally a component of evidence required in the appro val pro cess. • Anticipate unintended consequen ces and devise effec tive data analytics , monitoring , and responses at the outset of a trend. A small , but signifi cant portion of patient s and other users or misusers of diverted prescription op ioids transitioned to hero in. Scree ning for OUD when redu cing opioid suppl y or creating a tamper-re sistance form ulat ion, and implementing proce dur es to ass ist treating OUD patients conce ivab ly could have avo ided the transition for some people. • Appl y the lessons learned to cun ent movements to medic alize and legalize other Schedule I drugs. The catalyst of the opioid cri sis was a denial of its addi ctive potential. • Pha1111a ceutica l sponsorsh ip of meruca l society even ts needs rigorous oversig ht and rev iew . • Without adeq uate training in pain management and in addict ion diagnosis and treatment , the mediGal esta blishment was caught off guard and .unpr epared for iatrogenic opioid addiction . Training in these disciplines shou ld be mainstreame d into eve1y level of med ical education, to address the current crisis and to prepare for inevitable iterat ions . • Hea lthcare insurers have a signifi cant role in attenuating th is public hea lth crisis. They can reduce opioid suppl y by declining reimb urseme nt for unn ecessruy opioid pre scriptions, and JAPGl ON DCP006FY 18004 _ 0000000 46 ONDCP-18-0107-A-000094 facilitate recovery by seamless reimbursement for medications and treatmeut services. Federal oversight on insurance company practices was inadequate as the crisis expanded . IAPGl ON DCP006FY 18004 _ 000000046 ONDCP-18-0107-A-000095 Current Federal Programs and Funding Landscape Overview Congress has not enacted full yea r appropriations for fiscal year (FY) 2018, which began October l , 2017 . The Federa l Go vernment is opera ting und er a Continuing Reso lution (CR) that will expire in December 20 I 7. The funding levels presente d in this report are cons istent with the ftmding leve ls represented in the FY 2018 President's Bud get , includin g FY 20 18 Requ est leve ls and FY 2017 CR (annualized ) estimates. Th e Presiden t's FY 2018 Budget R equest supports $27.8 billi on for drug control efforts sp annin g preventio n, treatment , interdiction, internat ional operations , and law enforcement across 14 Executive Branch departments , the Federal Judicia ry, and the D istrictof Columbia. This represents an increase of $279.7 million ( 1.0%) overt he annua lized CR leve l i11FY 20 I 7 of $27.5 billion. Within this tota l, the Budget suppo rts $1 .3 billion in investments authorized by the Comprehensive Addiction and Recove,y Act (CARA) , the 218 ' Centu,y Cures Ac,, and other opioid-specific programs to help address the opioid ep idemic. FY 2018 Funding Specific to America's Opioid Cnsis Reducing Overdoses. Reduc ing opio id overdoses, to includ e identifyin g those at risk of ove rdose , the sign s of overdose , and expanding the use of naloxone , are key pieces of the Adm inistration's strategy to address the opioid overdose epidemic. The FY 2018 Budget request for SAMHSA incl ude s $12.0 million for Grants lo Prevenl Prescription Drug/Opioid Overdose Related Dealhs. This program will provide continuati on grants to l O states to significantl y reduce the numb er of opioid ove rdo se-related death s by helpin g sta tes pmchase naloxone , equipp ing first responders in high-risk com muniti es, supp o1t ing educat ion on the use of naloxone and other overdose death prevention strategies (inc ludin g cover ing ex penses incuffed from dis semi nation efforts) , and prov iding tbe necessary mate rials to assemb le over dose kits. Thi s program was appropriated $ 12 million in FY 2 016 and $ 12 mi llion in the FY 2017 CR. Th e FY 2018 Bud ge t request for the C DC includes $70.0 million for the Pres ctiplion Drug Overdose Prevention fo r S101es pro&.,ramto cover overdoses from opioi ds and other dru gs, the same leve l as the FY 2017 CR . 111isprogram , which advances and eva luate s comprehen sive state-level int erventions for preve nting prescr iption drng overnse , misuse , abuse , and overdose , is ex panding to a ll 50 state s and the District of Co lumbia in FY 20 I 7. Funds in FY 20 l 8 will support state efforts as we .IIas rigoro us monitoring, evaluat ioll, and irnprove ment s i_n data quality at the natio nal Jeve l. Funds will a lso be used to increase uptake am ong providers of the CDC's Guideline for Prescribing Opioids for Chronic Pain, as well as imple mentation of a coo rdinated care plan that addre sses both opioid and heroin overdose pre ve ntion by improvin g care for hjgh-risk opioid patiems . The FY 20 18 Budget request also includes $5.6 million in fundi ng for the CDC to address the rising rate of heroin-re lated ove rdose death s by work ing to collect near real-time ED data and JAPGl ON DCP 006 FY 18004 _ 000000046 ONDCP-18-0107-A-000096 higher quality and timely mortality data by rapidly integrating death cert ificate and toxicology info1mation. Th is is a small increase above the FY 2016 appropriation and level with the FY 2017 CR. Apart from these programs , the FY 20 18 budget request continu es to provide funding fo r expan sion of electro nic death reporting to provide faster, better quality data on deaths of public health importance , including presc ripti on dru g overdose deaths. Enhancing Prescrip tion Drug Monitoring Programs. POMP s are an imp ortant state -based health care too l. They provide information to health care providers so they can bette r understand what is being prescribed and intervene before a prescription dmg abuse disorder becomes chron ic. Currently , POMP s exist in 49 states. The FY 2018 request for DOJ's POMP activ ities includes $12.0 million for state grants to enhance the capac ity of regu latory and law enforcement agencies to collect and analyze controlled substa n ce prescription data. Tl1e FY 17 CR leve l for POMP activit ies was $13.0 million, leve l with the FY 2016 final budget. The purpose of OOJ's POMP effort is to enhance the capacity of regulatory and law enforoemen t agenc ies to collect and analyze contro lled subs tance presc ription data. Iu coo rdinatio n with HHS, the program aims to assist states that wan t to establish or enhance a PDMP . Objectives of the program include building a data collec tion and analysis system at th e state level , ehhanc ihg exis ting programs' ability to analyze and use collected data, facilitati ng the exc hange of collected prescrip tion data between states , and assess ing the effic iency and effectiveness of the programs funded under this initiative. Th e FY 20 18 Bud get for SAMHSA includes $58.4 millio n for the Strategic Prevention Framewo rk. Within this amo unt , SAM HSA will target $10 million to address prescription drug (including opioids) abuse and misuse , use POMP data for prevention plannin g, and implement evidence -based practices ahd/or eJwironme ntal strategies aimed at reducihg presc ription dmg abuse and misuse . The fina l spendin g leve l for the Strategic Prevention Framework progra m was appropriated $1 19.5 mi llion in FY 2016; in FY 20 17, the CR leve l was $ 119.3 million. Medication-A ssisted Treatme 11tProgrllms. MAT is an evide nce-based treatment for individ uals wi th OUDs. However, it is und erutil ized and often not availab le to those who cou ld benefit from its administration . Expanding access to MAT , in com bination with other behavioral health care , will he lp address this issue and help more individua ls sustain their recovery from OUD s. The FY 20 18 Budget includes $25 .0 milli on for SAMHSA, to supp ort the MATfor Prescripiion Drug and Opioid Addiction program for sta tes, level with funding for FY 20 16 and the FY 2017 CR. In FY 2018, SAMH SA plans to expand and enhance its program to improve access to MAT services for trea ting OUDs. SAMHSA anticipates 22 new states that have demo nstrated a dran1atic increase in treatment admissions for OUDs will be funded under tbe FY 2018 request. Medication-A ssis ter/ Trellt111 e11tin the Criminal Justi ce Sys tem. The Bureau of P1isohs ' (BOP) budget contains $ I .0 m illion in new reso urces to expand the MAT Pilot. The pilot provides an opportun ity to eva luate whether MAT should be expanded in the corrections sett ing. Resitle11tif1lS11hst1111 ce A buse Trelltment. The Office of Justice Program ' s budget contains $ 12.0 mil lion for the Resjde ntial Substance Abuse Treatment ( RSA T) program for state pr isoners , level with funding for FY 2016 and the FY 2017 CR. The program was esta blished to help state and loca l govern m ents develop , implement , and improve residentia l subs tance abuse trea tment [APGl ON DCP006FY 18004 _ 0000000 46 ONDCP-18-0107-A-000097 programs in correctiona l fac ilities , and estab lish and maintain comm unity-based aftercare services for probationers and parolees. It is intended improve public safety and reduce crimi nal recidivism by he lping offenders become drug-free and learn the skills needed to susta in themsel ves upon return to the commu nity. Enltan cetl Drug Enforce ment Efforts. The Budget provides increases to federal law enforcernent agencies aimed at reducing the flow of illicit drugs into the country and increas ing investigations of transnational crim inal organization s, violent gangs, and dmg traffickers. Specifically: The FY 201 8 Budget includes funding to maintain and expand capacity to fight against h eroin and other illicit drugs at the DOJ . This inclttdes a total of $2.6 billion for the DEA , including $21 mill ion in new discretionary resources are requested for DEA and $32 million in new mandatory resources for the DEA ' s Diversion Contro l Program to reduce the diversion and abuse of pharmaceutical controlled substances and listed chemicals , including prescription opioi ds. The overall DEA re.quest for FY 2018 is an increase of $158.1 million over the FY 20l6 level and $150.3 million over the FY 2017 CR level. The FY 2018 Request for the DOJ also includes $526.0 million for Orgm1ized Crime and Drug Eofoccement Task Force (OCDE TF) to support heroin enforcement efforts, address transnational organized crime, and to reduce violent crin1e in cities across the nation. The request is an increase of $14.0 million above the FY 20 16 and $15.0 million more than the PY 2017 CR and wi ll enhance heroiu enforcemen t efforts , address transnational organi zed crime, and reduce vio lent crime in cities across the nation . Drug Prevention. The Drug Free Communities (DF('J Support Program is built upon the idea that loca l problems requ ire local solutions. DFC funding provides fo.rthe bo lstering of community infrastmcture to suppor t environmenta l prevention strategies to be planned , implemented , and evaluated in communities acros s the United States, TeL,itories and Protectorates . The DFC Program is guided by locaJ communities who identify and develop evidence-based strateg ies to reduce drug use and its consequences. For FY 2018 , $91.8 million will fund approximately 659 DFC grams and cont inue the DFC National Cross-S ite Eva luation. This program received $95.0 million in FY 16 and $94.8 million io FY 2017 through CR. A,ltlressing Domestic am/ Tr1111 snatio11al Org,111ize1l Crime. Tbe Administration will employ tools to disntpt the flow of illicit drug s into our countty , and reduce drug trafficking domestically. In an effort to enha110esecu rity at the Southwest Borde r, in the FY 2018 President ' s Budget , CBP requests $260.5 million to fund acquisition , delivery , and sustainment of prioritized border security capabilities. This is a new activity , reflecting the President's comm itment to border sec urity. The HIDTA program, created by Congress wit h the Anti-Dmg Abuse Act of 1988, aids federal , state, local , and tribal law enforce me nt agencies operating in areas determined to be critical drugtrafficking regions of the United States. A total of $246.5 million is requested for the H IDT A program in FY 2018, a decrease from the FY 20 16 funding level of $250.0 million and the FY 2017 CR funding level of $249.5 million. IAPGl ON DCP006FY 18004 _ 000000046 ONDCP-18-0107-A-000098 The Com pre hensive Add iction and Recover y Act (CARA) The Comprehensive Addi ction and Recove1y Act (CARA) authorized new programs to help fight the scourge of opioid abuse plaguing our Nation , and authorized appropriations for existing programs to contin ue their work . Highlights of these programs are below: In FY 20 I 8, SAMHSA is requesting $12.0 million for the Preventing Prescription Drug/Opioid Overdot,e-Related Deaths (PDO II) program , authorized in CARA. FY 2018 is the first-time appropriations for this newly-authorized program wilJ be requested . Tbe purpose of this program is to reduce the number of prescription drug/opioid overdose-related deaths and adverse events among individuals at risk for OUD. App licants will train first responders and members of other key commun ity sectors at the state , locaJ government , and tribal levels to implement secondary prevention strategies , such as the administration of naloxone through FDA-approved del ivery devices to reverse the effects of opioid overdose . SAMHSA is also requesting $1.0 million to support a new cohort of grants through the Buildin g Commu11itie s of Recove1J1program. This program mobilizes resmirces with in and outside of the recovery community to increase the prevalence and quality of loug-tenn recovery support for people with SUDs. These grants support the development, enhancement , expansion , and delivery of recovery support services. as well as promotion of and education about recovery. At the DOJ, the Office of Justice Programs is requesting $20.0 million for grants under the Compreh ensive Opioid Abu se Program . This new program aims to support cross-system collaboration ; develop and implement strategies to reach survivors of non-fatal overdoses and their loved ones; provide treatment and recovery sllpport services ; expand diversio n and alternative to incarceration programs ; expand services in rural or tribal communities; implement and enhance PDMPs ; and assess the impact of new strategies. At the VA, $50 million authorized under CARA is being requested for activities to increase opioid safety practices and improve care for Veterans within the Veterans Health Adn.1.i.n istracion. VA begah implementation of these activities with CR funds in FY 2017. 2 1st Century Cu res Act The 2 JS1 Centw :y Cures Ac, provjdes a tota l of $970 million over two fiscaJ years (FY 20 17 and FY 2018) to HHS to address the opio id crisis by increasing treatment , reducing unmet treatment need , and reducing opioid overdose related deaths through the provision of prevention , treatment , and recovery activities for OUD (includi ng prescription opioids, as well as illicit drugs such as heroin). SAMHSA is administering the 21s1 Centu,y Cures Act funding through the Stat e Targeted Response to the Opioid Crisis Grants . The President's Budget requests $500 million for state grants under this program . Grantees use ep idemio logica l data to drive decision-making , rapidly address gaps in their systems of care, implement prevention strategies , deliver RSSs , and report progress on expanding treatment and reducing opioid overdose death s. JAPGl ON DCP006FY 18004 _ 000000046 ONDCP-18-0107-A-000099 Federal Drug Resources by Funct ion $ 12.0 $10.0 $8.0 $6.0 $4.0 $2.0 $P1,1ve,itiGr, FY2016 Tt.?Jtmt111t Oornest11: law Enforcement CIII tnte,rJlct1011 lnt<-r11.1t1011;,I $1.5 $%- 593 34.l S,1.5 I FY}(tl7 $1 '.:> SlOE> Sa<, ~l .S ■ $1.3 S10.s $9 3 S92 s~o ~1.4 tY 2018 Figure 6. Drug Resources by Function FY2018 Consolidated Federal Drug Cont rol Budget The consolidated Na tional Drug Control Bud get detai ls agency reso urces by function. Function s categorize the activities of agencies into com mon drug control areas. Figure 6 details funding by fun ction . Prevention Preventing drug use before it starts is a fundamental element of a com pre hensive approach to drug control. Federa l resources total ing $1.3 billion in support of educat io n and outreac h programs has been requested to educate you ng people about tbe consequences of drug use and prevent yout h initiation . This represents a decrease of $ 167.5 million ( 11. 1%) over the FY 20 17 level ; the major effort s are highlighted below : Substance Abu se Prevention and Tnatment Block Grant ($370 .9 million) Dep<1rt111 e11tof Health "'"[ Human Services - S11h sta11ce Abus e and 1il e11tal Health Services Ad ministration Twe n ty perce nt of the $1.9 b illion (i.e ., $370.9 million) Su bsta nce Abu se Prevention and Trea tment B lock Grant is the minim um set aside to st1pport prevent ion services. State S11bstance Abuse Administe ring Agencies use these funds to develop infrastruc tm·e and capac ity specific to SUD prevention . Some State Substance Abuse Adm inistering Agencies rely heavily on the 20% set-asi d e to fund prevention , target gaps in prevention serv ices, and enhance existing program efforts. IAPGl ONDCP006FY18004_000000046 ONDCP-18-0107-A-000100 Education 's Preve ntion Efforts ($48.9 million) Department of Etl1tclltio1Z The $48.9 miJlion request iucludes $46.3 million for Scboo l Climate Transfo rmation Grants ru1d related technical assistance. These funds help create positive school climates through multi-tiered decision-maki ng frameworks that guide the selection, integration , and implementa tion of the best evide nce-based behavioral practices . A key aspect of this mul ti-tiered approach is that it provides differing levers of support and interventions to students based on their needs . 1n schools where these frameworks are implemented well, there is evidence that youth risk factors are improved: improved risk factors are corre lated with reduce d drug use, among other improved behaviors. Pre,1e11tio11 Research ($331.9 million ) Department of Health ,md Human Services - National Institutes of Health Nlli 's N I DA invests in genet ics, neuroscience , phannacotherapy , and behavioral and health services research , producing inJlovative strategies for preventing SUDs. In addition, NIDA is supporting researc h to better understa nd the impact of changes in state policies related to marijuana Through N]AAA, the NIH helps to deve lop strategie s to preve nt the short- and longterm consequences of alcohol use among youth . Drug ged Driving ($2.72 million) Depllrfment of Transportation, N<1ti omzl Highway Traffic Safety Administmtion NHTSA 's FY 2018 request supports the Dru g-impaired Driving Program, which provides public information , outreach efforts , and impro ved law enforceme nt training to help reduce drugged driving. Funding will also allow NHTSA to continue to conduc t research designed to reduce the incidence of drug-impaired drjving. Anti-Doping Acti\'ities/Wor ld A nti-Doping Agency Dues ($11.8 million) Office of Nlltional Drug Control Policy Anti-do ping activ ities focus on efforts to educate athletes on the dangers of drug use, eliminate doping in amateur athletic competitions, and rely on standards established and recognized by the United States Olymp ic Com mittee. Fw1ding for both efforts promotes an increased awareness in tbe United States and internationally of the health and ethical dangers of illicit drug use and doping in sport. Funding and partic ipation in the Anti-Dopi ng Activities /World Anti-Dopi ng Agency is necessary to compete in internat ional events. These activities support state-of-t he-rut research within the scientific and public health communiti es, while striving to protect athletes' fundamental rights to participate in drug-free sp01ts, and thus promote the health and safety of athletes at all levels. Treat ment and Recovery Treatment and recovery support services are essentia l elements of reducing drug use and its consequences . The FY 2018 Budget proposes $10 .8 billion, an increase of $202.6 million (1.9%) over the FY 20 I 7 annualized CR level in fe deral funds for early intervention, treatment , and recovery services . SUD treatment services need to be integrated better into primary care settings, made more widely accessib le, and made eligible for insurance coverage on par with other medica l conditions. The major efforts in this area include the following: IAPGl ON DCP006FY 18004 _ 0000000 46 ONDCP-18-0107-A-000101 Medicare- & Medicaid -funded Substance Abuse Treatm ent Services ($5,840.0 million) Department of Health ,md Human Services - Centers for Medicare & Medicaincou ntries, and pro vides intelligence to assi st the i11teragency communi ty in deten11i11ing future trends in dru g trafficking and eva luating their long-term impact. DEA works closely with the United Nati ons, Interpol, and other organizations on matter s rela ting to internat iona l drug and chemica l contro l progra ms . Bureau of International Narcotic s and Law Enforcement Affairs {$290.3 million) Dep artment of State In support of the Strategy, Bur eau oflntemational Narcotics and Law Enforcement Affairs (INL ) works closely with par tner nations and source countrie s to disrupt illicit drug pro duction , strength en crimina l justice system s and law enfo rcement institution s, and combat transnational organ ized crime. [NL is comprehensive in its approach to the co nnterdni g mis sion and pro vides training and technical ass istance for prevention and treatment programs. United States Agency for International Developm ent ($83.6 million) D epa rtm e11tof State Th e Un ited States Agency for International Development (USA ID) pro vides foreign assistance funds to develop ho tistic altern atives to illicit drug production by pro viding agric ultural assistance , improving sma ll sca le infrastn 1ctme , increasing ma rket accessibility , and incentiviz ing licit crop produc tion. USAID 's alternative developmen t pro grams foster econo mic growth, loca l governa nce and civil soc iety streng thening , and enhanced secur ity of impacted communities . DOD International Co u.nternarcotics Efforts ($491 .1 million) Department of Defe nse The internat ional support programs of DO D 's Com batant Comma nds detect , interdict , disrnpt , or monitor activities related to drug hafficking organiza tions and transnationa l criminal organiza tions . In the Western Hemisphere Transit Zone, DOD fun ctions as the comm and and control support for counter dru g activ ities for federal , state . local and interna tional partner s. JAPGl ON DCP006FY 18004_ 0000000 46 ONDCP-18-0107-A-000106 Table 3. Federal Drug Control Spending by Function FY 2016 - FY 2018 (Budget Authority in MiJJions) FY2016 Final FY 2017 CR FY 2018 Request Function Treatment Percem $9,845. 1 36.6% $ I 0,580 .8 3 .5% $ I 0, 783.4 Prevention Percent 1,486.4 5.5% 1,507.4 5.5% Domestic Law Enforcement Percem 9,282.8 34.5% Interdiction Percent International Percent FYI 7 - FY18 Change Dollars Percent $202 .6 1.9% l,339.9 4.8 % -167 .5 -11.1% 9,298 .6 33.8% 9,235.8 33.3 % -62.8 -0.7 % 4,734.7 17.6% 4,569 .0 16.6% 5,022.4 18.1% 453.4 9.9% 1,524 .9 5.7% 1,521. 0 5.5% I 375.0 5.0 % -146 . l -9.6% Total $26 ,874.0 $27 ,476.8 $27,756,5 $279 .7 1.0 % Supply/Demand Demand Reduction Percent $11 ,331.5 42.2% $12,088.2 44.0% $12,123.3 43.7 % $35. l 0.3% 15,542.5 57.8% 15,388 .6 56.0 % 15,633.2 56.3 % 244 .6 1.6% $26,874.0 $27,476.8 $27 ,756.5 $279.7 1.0 % Supply Reduction Percem Total 38.9% fAPGl ONDCP006FY18004 _000000046 ONDCP-18-0107-A-000107 Table 4. federal Drug Control pending by Agency (Budget Authority in Millions) FY2016 Final ---------FY 2017 FY2018 CR Request Department of Agriculture U.S. Forest Service Court Services and Offender Supervision Agency for the District of Columbia 12.3 12.9 15.6 55.4 55.3 56 .1 1,302.8 1,2.99.4 1,127.8 76.7 1,379.5 75 .8 l,375.1 76.7 1,204 .6 50 .3 49.1 48.9 1,147.8 1,166. 7 1,210.9 18.5 75.6 5,390.0 119.0 104.7 55.2 1,049.0 2,533.7 9,345.7 18.6 75.4 5,550.0 121.0 104.9 55.2 1,075.4 3,052.1 10,0SZ.7 5,840 .0 171.0 105.1 42.7 865.0 2,943.2 10,062 .5 2,687.2 8.3 44.1 508.9 1,59 7.1 4,845.6 2,663.7 8.3 43.9 514.7 1,4 56.0 4,686.4 3,11 8.7 6.2 49.3 524.6 1.4 52.7 5,151.5 490.5 489.5 494 .2 9.7 5.1 3.5 18.3 9.7 5.1 3.3 18.1 Department of Defense Drug Interdict ion and Counterdrug Activ ities 1 (incl . OPTEMPO, DSCA,and OCO) Defense Health Program Total DoD Department of Education Office of Elementary ahd Secondary Education Federal Judiciary Department of Health and Human Services Administration for Children and Families Centers for Disease Control and Prevention Centers for Medica re & Medicaid Servlces1 Health Resources and Services Administrat ion Indian Health Service Nationa l Institute on Alcohol Abuse and Alcoholism National Institute on Drug Abuse Substance Abuse and Mental Health Services Administrat ion 3 Total Health and Human Services 20.0 75.A Department of Homeland Security Customs and Border Protection Federal Emergency Management Agency Federal Law Enforcement Training Center lmm.igratfon and Customs Enforcement United States Coast Guard Total Homeland Security Department of Housing and Urban Development Community Planning and Development Department of the Interior Bureau of Indian Affairs Bureau of Land Management National Park Service Total Interior 9.3 5.1 3.3 17.7 JAPGI ONDCP006FY18004 _ 000000046 ONDCP-18-0107-A-000108 FY2016 Final - FY2017 CR Department of Justice Assets Forfeiture Fund Bureau of Prisons~ FY2018 Request 258 .4 3,532.6 39 .0 2,425.5 512 .0 278 .2 72 .6 771.3 7",889.7 230.1 3,526.0 38.0 2,433.4 511.0 297.7 72.6 792 .8 7,901.7 227.5 3,403 .8 37 .7 2,583.6 526 .0 240 .2 78.1 812 .8 7,909.7 5.7 6 .0 6.0 Office of Nationa l Drug Contro l Policy High Intensity Drug Traff icking Areas other Federal Drug Control Program s. Salaries and Expenses Total ONDCP 250 .0 109.8 20.0 379.9 249 .5 109.6 20.0 379.l 246.5 103.7 18.4 368.6 Department of State 5 Bureau of Interna ti ona l Narcot ics and Law Enforcement Aff;; United States Agency for Internat ional Development Total State 405 .3 70.5 475.8 404.5 70.4 4}4.9 290.3 83.6 373.9 30.4 31.7 Crim inal Division Drug Enforcement Administration Organ ized Crime Drug Enforcemen t Task Force Program Office of Justice Programs U.S. Attorneys U.S. Marshals Service Total Justice Department of Labor Employmen t and Training Adm inist rat ion Department of Transportation Federal Aviation Administratio n National Highway Traffic Safety Admin istration Total Transportation 3.S 33.8 31.6 2.7 34.3 34 .4 Department of the Trea$ury Internal Revenue Service 60.3 60 .3 60 .3 683.4 $26,874.0 714 .6 $27,476.8 741 .7 $27,756.5 Department of Veterans Affairs Veterans Health Administrat ion Total Federal Drug Budget u Due to statu tory changes included in the FY 17 Nn1iom1I Defen se Autho rization Ac1 that consolidated the DO D's security sector assistance allthorities, fimd:ingfor buildin g foreign parmer counter-drug enforcc1J1e nt capacities is now included iu DOD's Defense Security Coopenitjon Agency' budget request. i _ Th e estima tes for the CMS rclJect Medicaid and Medicare benefit outlays (c.xcludiJ 1g spend ing under Medicare Pan D) for substance use diso rder uemment ; they do not reflect budget authorit .. The methodolo gy for Medicaid estimates has been [efi.11 ed from prior yea rs to more accurately reflect spending . Tbe estimates ere de eloped by the CMS Office oftbe Acmary . 1 Includes budget authority and funding through evaluation set-aside au 1hori2ed by Section 24 I oft11e Pub lic Health Servi ce (PHS J Act. ·'- Funding for tl1e FY _Q18 column excl udes a proposed rescissio n of unobligated balances . 5- Funding for 2017column is a meclrnnical calculati on that doe' not retlecl decisions on funding priorities . ~ Dc11:1.i l may not add due to rounding 1 IAPGl ONDCP006FY18004 _000000046 ONDCP-18-0107-A-000109 PRESIDE NT 'S COMM ISSION ON CO~IBATING DRLG ADDJcr ro • AND THE OPIOID CRJSJS -------~------------- Com mission Charter -------------- - ----- -------- 1. Committee's Official Desi.gnatioo: Presjdent's Commissioo oo Combating Drug Addiction and the Opioid Crisis {Commission). 2. Authority: The Commission is being established in accordance with Executive Order o. 13784 of March 29, 2017, and the provisions of the Federal Advisory Committee Act tFAC J\ ), as amended, 5 U.S.C. App. 2. 3. Objectives and Scope of'Acth•ities: The Commission is established in the interest of obtaining advice and recommendations for the President regarding the opioid crisis. The Commission \\ill function solely a~an aJvj ~ory hody and will ml'lkerecommendations regarding policies and pracLicesfor combating drug addiction \vith partfouJar focus on the cu1Tent opioid c1isis iu the United States. The heads of executjve departments and agencies sball , to the ext.en! permitted by law, provide the Commission with informa tion concern ing drug addiction and the opio id crisis ,;,•hen requested. To ach ieve this goal. the Commiss ion shall : a. identify and describe the existing Fede ral fundi ng used to co,ub at drug addiction and the opioid crisis; h. assess tht::availability and accessibility of drug addiction treatm ent services and overdose re versal throughou t the country and identify areas that are underserved; c. identify and report on best practices for addiction preven tion, including healt hcare provider edu cation and evaluation of pr esc ription practices, collaboration between State a:ndFederal officials, and the LlSeand effectiv eness of Stare prescr iption drug monitoring programs: d. review the literature evaluating the effective ness of educmional messages for youth and adults with respect to prescription and illicit opioids; e.. identify and evaJuatt::existing Federal programs to prevent and treat dm g addictio n for th.eir scope and effectiveness, and make recommendations for improving these prn grams; and f. make recommendationsto the President for improving the Ferdrugs thatmaybelaced withtll>5esubstances. (e.g..acetylfentanytacrylfertanyl,carfentanU, ► ► ► The abuse of drugs cont ain ing fentanyr Is ki lli ng Americans . Mis.In forma ti on and Inconsistent recom mendati ons regard ing fentany li have result ed In confusion in t he fir st respond erc_ommunlty . Youas a first responder (lawenforcement, fire,rescue, and emergency medical services (EMS)personnel) are increasing~ likelyto encounter fentanylt in your dailyactivities (e.g., responding to overdose calls,conducting traffic stops, arrests, and searches). This document provides scientific,evidence-based recommendations to protect yourselffrom exposure. WHAT YOU NEED TO KNOW ► Fentanylr canbe presentIn a variety of forms (e.g~ powder, tablets, capsules,sohnrons, and rocks). ► lnhalatlon of airborne powder Is MOSTLIKELYto lead to harmful effects, but Is less llkelyto occur than skincontact ► Incidental skincontact mayoccurduring dally act1vlt1es but Is not expectedto lead to harmfuleffectsif the contaminatedskinIs promptlywashed offw1th water. ► PersonalProtectiveEquipment(PPE ) ls effectiveln protecting you from exposure. ► Slow breathfngor no breathing, drowsinessor unresponsiveness , and constrlcted or pinpoint pupilsare the specific slgis consistentwith fentanyrlntoxlcat[on. ► Naloxonels an effective medicationthat rapidly reversesthe effectsoffentanylT. CV ~ B To prot ect your self from expo sure ► 0 ► V'I ► +J C 0 ► Wear gloves when the presence of fentanyll is suspected . AVOIDactionst hat may cause powderto become airborne. Use a propedy-fitted, NIOSHapprovedrespirato r ("mask"). wear eye p rotect ion.and minimize skincontact when responding to a Slituationwtieresmallamounts of suspected fentanyl' a,re visible and may become airborne. Followyour department guidelines ifthescene involves large amounts of suspected fentanyft (eg ., distribution/storage fadtity, pill millingoperation, clandestine lab, gross contamination, spillor release). C.ORaborative, -con Support From, When exp osur e occurs • -an dll la'lofSbleana T«ito rt,,IHa llth Ollid ~ S ◄ M!ID:lll1Cr 1afStrfeCnmN ILnwrug11Uwa AgOndm ► ► Prevent further contamination and notifyother first responders and dispatch. Donot touch your eyes, mouth, nose or any skinafter touching any potentially contaminated surface. Washskin thoroughly with cool wate r, and soap if available. Do NOT use h and san ltlzers as th ey may enhan c.eabso rptio n. Washyour hands thoroughly after the incident and before eating, drinking, smoking, or using the restroom. If yoususpect your clothing,, shoes, and PPEmay be contaminated, follow your department guidelines for decontamination. • liltcmrt10MI' "''"'lrtlon d Clllllls If you or oth er fir st responder s exhibit - Slow Breath ing o r No Breat hing - Drowsiness or Unresponsiveness - Constricted or Pinpo int Pupils ► ► ► ► Moveaway from the source of e,c:posureand call EMS. Administer naloxone according t.o your department protocols. Multipledoses may be required. lfnaloxone ls not available, rescue breath ing can be a lifesavingmeasure until :EMSarrives. Usestandard basic life support safety precautions (e,g, pocket mask, gloves) to address the exposure risk If needed.initiate CPRuntil EMS arrives. of"""" , N11JcotlAS10CllllOnafau'()'•ndcrty • NIUOl'l.lfAIIOCUtton ofccc.nllS • Nrtlon afGl:Ml1K>r'SAS.10tl.'Uon .. N.ttlonaf HOTA Oncl0ISABOCllnon !toot hOffioa~ • Nlllontl A.. 0<11Hc<1 afEmorgoncyModlcal TIK.hn1e11n1 • NrUooal Nrrcotlcotfmrs'A&x .llttons'Coelt:Jon • NIUfflalSilal1fl,'-.ucr, .. .Nl'.UOflllA.sloebDonof EMSl'fv$k:IIIIIB • Pdlc»EUafflWRD.$1MrchFM.nl • Nlll"'1al AJ!oc:bH0ftolSIIU EMSOfficials , Pdlm FClndrUtn • lll'birTVtlOMIAnocutlon d AreChlln • ,.- ... , A-lrtl•n d RroFlglt ll' S • Ml!«otfosehl0h-dll1"' • MIJOfCCUn~Sh1'1hdAl!l1nca • NaU:N INl~nc»dS-DN! Effbromn ,tgondH , Ftatiff>I I0d;r olI'd ka • Nltlonaf't'OfunbwFRCOlltCII ,PG] https:f/ www.wh iteho use.gov/o ndcp/ key-issues/fen tanyl ONDCP 006FY18004_000000046 ONDCP-18-0107-A-000128 References 1 Poner J. Jick H. 1980, Jan 10. Addiction t•are in patients treated with narcotics.N E11glJ Med. 302(2): 123. 2 Leung PTM, Macdonald EM, Stanbrook MB, Dhalla IA, Juurlink DN. 20 17, Jun l. A 1980 Leller on the Risk of Opioid Addiction. N h'ngl J Med. 376(22):2194-2 195. , Chronic use of opioid analgesics in non-malignant pain: repon of 38 cases._Pone uoy RK, Foley KM. Pain. 1986 May:25(2): 17J-86. PMID: 287;55n https://www.ncbi.nlrn.nib.gov/pubrued/2873550 1 Melzack R. 1990. The tragedy of needless pain. Sci Am. 262(2):27-33. 5 Porteooy R.K. 1990, Feb. Chronic opioid tJ1erapy in uonmalignant pain. J Pain Sy111p10111 Manage ( I Suppl):S46-62. 6 Max MB. Improving outcomes of analgesic treatment: is education enough? Ann 111/ ern Med. 1990;113( 11):885889. 7 Max MB. Improving outcomes of analgesic treatment: is education enough? A 1111 111/ em Med . 1990 ; 113( ll ):885889. 8 PRESCRIPTION DRUGS OxyContiu Abuse and Diversion and Efforts to Address tbe Problem. Available at https://www.gpo.gov/fdsys/pkg/GAOREPORTS-GA0-04- l 10/pdf/GAOREPORTS-GA0-04-11 0.pdf q Bloomquist ER. 1963 Aug. The addiction potential ofox ycodone (Percodan). Cali/Med. 99: 127-30. 10 Van Zee A. 2009. The promoion mid marke1ing of OxyContin: commercial triumph, public health 1ragedy.Am. J. Public Health 99:22 1-27. 11 Skolnick P. The Opioid Epidemic: Crisis an d Solutions. Annu Rev Pbannacol Toxicol. 2017 Oct 2. [Epnb ahead of print I 12 Dart RC, Surratt HL. Cicero TJ. Parrino MW, Severtson SG, el al. 20J 5. Trends in opiold analgesic abuse and mortality u1LbeUnited Slates. N. Engl. J. Med. 372:24 1-48 13Cicero TJ. Ellis MS, Surratt HL, Kurtz SP. 2014. The ch,rngiug face ofberoiu use in the United States: a retrospective analysis of the past 50 years. JAMA Psychiatry 7 l :82J- 26. 14 The United States Senate Committee on Finance Website. http://www.linance.senate.gov/chainnans-news/baucusgrassley-seek-dia.gn osiss-abouL-opioid-ma.nufacturers-ties-Lo-medieal-groups. 15 Lin DH. Lucas E, Mnrimi TB. Kolodny A, Alexander GC. 20 17 Mar 1. Financial Connicts of1nterestan d the Centers for Disease Contrnl and Prevention's 2016 Guideline for Prescribing Opioids for Clu·onic Pain. JAMA ln rern M ed. I 77(3):427-42fL ° Cicero 1 TJ, Kurtz SP, Surratt HL, Ibanez: GE, Ellis MS, Levi-Minzi MA, lnciardi JA. 201l spring. Mulliplc Dcterminams of Spccilie Modes of Prescription Opioid Diversion, J Drug Issues. 4 1(2):283-304. 17 Campbell 18 JN. APS 1995 Presidential address. Pain Fonun. l996;5:85- 8. Veteraus HealU1 Administration. Pain as the 5th Vital Sign bttps://www.va.gov/PAfNMANAGEMENT/docs/Paiu_As_Lhe_ 5th_Vita1_ Sign_Toolkit.pdf. Toolkit. 2000. 19 Phillips OM. 2000. Jul 26. JCAHO pain management standards are unveiled. Join! Commission on Accreditation of Healthcare Organiz...1 lioos. JAMA. 284(4):428-9. 20 Baker DW. 20 I 7. Mar 21. History of Tile Joint Commission's Pain Standards: Lessons for Today's Prescription Opioid Epidemic. JAMA. 3 17(1I ):1117-1ll 8. 21 Baker DW. 20 l 7, M ar 2 1. History of The Joint Commission's Pain Standards; Lessons for Today's Prescription Opioid Epidemic. JAMA. 3 17( 11):ll 17-1118. 22 Cbbabra N, LeikiJ1 JB. 2017. Jul 4. 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Rockvi lle, MD. 18M btlµ ://www. hcah psonlinc.o 189 b.ttps://www .medicarc rg/b ome .aspx .gov/b.ospitalcompare /abon Vwhut-is-HOS .hunJ 110 19 1 Jena AB I. Goldman D2, Karaca-Mandic P3.20 1.6, Jul I. Hosp ital Prescribiu g ofOpioids to Medicare B eneficiaries JAMA /11/em Med 176(7):990-7 . doi: I O.l001/ja mainternmed.2016.2737. 192 Jena AB I, Gol dman D2, Karaca-Ma.ndic P3. 20 16, Jul 1, Hospital Pre sc1il.ling ofO pioid s to Medicare Benefici aries J;fMA lntem Med. 176(7):990-7. doi: 10.I00l/jamaiuternme d.20 16.2737 . m Chughlai MI , Jauregui JJ I, Mistry JB I, Elmallah RK I, Died1ich AM l , Bonutt:i PM 2, Delanoi s RI , Mont MA I. 1. 20 16, Apr. Wl1at Influence s flow Patients Rate Their Hospital After Total Knee Artl1roplasty? S11rgTee/mo/ / 11 28:26 1-5. fAPGI ON DCP006FY 18004_ 000000046 ONDCP-18-0107-A-000138 JB. Chu ghtai M. Elma IIah RK. Le S. Bonutti PM. Dcla nois RE, Mont MA. 20 16. Nov. What lnlluences How Patients Rate Their Hospital Aller Total Hip Arthroplasty? J Arthropla sty . 31( 11):2422-2425 . doi : 10.1016/j.arth.20 16.03 .060. £pub 2016 Apr 13. PMID : 27 I 55998. JQW\vw.bhs.gov/news< Twitter @ HHSMedin FOR IM.MEDIATE RELEASE Tuesday, December 12, 2017 Acting HHS Sec retary Hargan Holds High-Level Opioids Meeting On Tuesday, December 12, Health and Human Services (HHS) Acting Secretary Eric D. Hargan held an unpre.cedeutedmeeting with leaders from across the healthcare and human services components of HHS to discuss strategies for addressing America's opioid crisis. Following HHS's declaration, at President Tmmp's direction, of a historic uationwide public hea lth emergenc y rega rding the crisis , t he meeting encouraged a new level of discussion and cooperation among key leaders of HHS 's divisions. Acting Secretary B argan offe red open ing remarks hi ghlightin g the ded ication HHS has shown in 1·esponse to President Trump's call to action on the cr isis. Leaders of operating divisions and staff divisions of HHS then shared updates on U1eirwork and their future plans for coordinating across the department. ONDCP006FY18004_000000722 ONDCP-18-0107-A-000157 Ii X II X Principals attendin g the meeting includ ed: Eric D. Hargan, Acting Secretary and Deputy Secr etary ~ Elinore F. McCance-Katz , M.D ., Assistan t Secretary for Mental Health and Substance Use; Brenda Fitzgerald , M.D. , Dir ector, Centers for Di sease Contro l and Prevention ; Fra ncis Coll ins, M.D ., Director of the National In stitutes of Health ; Scott Gottlieb, M.D. , Comm issioner, Food and Drug Adm inistration; Seema Venna , Administrator , Cen ters for Medicare & Medica id Serv ices; George Sigounas, Admin istrator, Health Resources and Service Admi nistration; RADMMichael Weahkee , Acting Director , fudian Health Service; Gopal Khanna, Director, Agency for Healthcare Research and Quality ; Mary Lazare, Principal Deputy Adm inistrator , Administrat ion for Community Living ; VADM Jerome Adams , U.S. Surgeon General ; Don Wright , M .D., Acting Assistant Secretary for Health; Roger Sever ino, Director. Office of Civil Rights ; Daniel Levinson , Insp ector General ; Donald Rucker, M.D. , Nat ional Coordinator for Health Information Techno 1%ry; and Bruce Greenstein , Ch.iefTechnology Officer Discussion was organ ized arotmd HHS ' s comprehensive five-poi nt strategy to combat the opioid crisis: • • • • • Better prev ention , treahnent, and recovery services Better targeting of overdose-revers ing drugs Better data on the epidemic Better research on pain and addiction Better pain mana gement To conclu de the meeting, Acting Secretary Hargan thanked the HHS leaders and all HH S staff for their work , reiterated the President's commitment to fighting the opioid crisis , and shared plans for ongoing regular meetings in the new year. ONDCP006FY18004_000000722 ONDCP-18-0107-A-000158 ### Connect with HHS and sign up for HHS email updates If you Would rather 1101receive future communications from U.S. Department of Health and Human Services (HHS) , let us know by clicking here, U.S. Department of Health and Human Services (HHS), 200 Independence Avenue . SW 6th Floo r Room 647-D, Washi ngton, DC 20201 United States ON DCP006FY 18004 _ 000000722 ONDCP-18-0107-A-000159 RE: Relevant data oint From "Passante, Michael J. EOP/ONDCP"= ------------..J To : "Bowman. Matthew (HHS/OGC) " EOP/WHO" Cc: "Charrow , Robert (HHS /OGC) " Date : Wed , 07 Feb 2018 22:58:38 -0500 "Amin. Stacy C. r-------- Thank you Matt! This is helpful. =--------- From:Bowman, Matthew (HHS/OGC) [mailto Sent: Wednesday, February 7, 2018 10:11 PM To: Amin, Stacy C. EOP/W HO --------- Passante , Michael J. EOP/ONDCP Cc:Charrow, Robert (HHS/OGC) Subject: RE: Relevant data point ONDCP-18-0107-A-000160