1 See generally Paradise, Jordan, 21st Century Citizen Pharma: The FDA & Patient-Focused Product Development, 44 Am. J.L. & Med. 309 (2018)CrossRefGoogle ScholarPubMed.

2 Kevin Campbell, The 21st Century Cures Act: Saving Lives Through Research, U.S. News (Dec. 26, 2016), https://health.usnews.com/health-care/for-better/articles/2016-12-22/the-21st-century-cures-act-saving-lives-through-research; Elaine Schattner, Why Patients Support The 21st Century Cures Act, Forbes (Nov. 30, 2016), https://www.forbes.com/sites/elaineschattner/2016/11/30/why-patients-support-the-21st-century-cures-act/#49251ddc4dd3 [https://perma.cc/Z2WB-Q696].

3 David Borasky et al., The 21st Century Cures Act: Implications for Human Subject Protections (2016); see generally Wolf, Leslie E. & Beskow, Laura M., New and Improved? 21st Century Cures Act Revisions to Certificates of Confidentiality, 44 Am. J.L. & Med. 343 (2018)CrossRefGoogle ScholarPubMed.

4 See generally Avorn, Jerry & Kesselheim, Aaron S., 21st Century Cures Act: Will It Take Us Back in Time?, 372 N. Eng. J. Med. 2473 (2015)CrossRefGoogle ScholarPubMed.

5 Comprehensive Addiction and Recovery Act of 2016, Pub. L. No. 114-198, 130 Stat. 695 (2016).

6 Hedegaard, Holly et al., Drug Overdose Deaths in the United States, 1999-2016, 294 NCHS Data Brief 1, 1 (2017)Google Scholar.

7 Id.; Kochanek, Kenneth D., Mortality in the United States, 2016, 293 NCHS Data Brief 1, 1 (2017)Google Scholar.

8 Mack, Karin et al., Illicit Drug Use, Illicit Drug Use Disorders, and Drug Overdose Deaths in Metropolitan and Nonmetropolitan Areas — United States, 66 MMWR Surveillance Summaries 1 (2017)CrossRefGoogle ScholarPubMed.

9 Chi. Urb. League, Whitewashed: The African American Opioid Epidemic (2017). See Ill. Dep't Pub. Health, State of Illinois Comprehensive Opioid Data Report (2017) (indicating that overdoses doubled among African Americans in just a one-year period).

10 Council of Econ. Advisors, The Underestimated Cost of the Opioid Crisis (2017).

11 See generally David Musto et al., One Hundred Years of Heroin (2002).

12 See Hedegaard et al., supra note 5 (illustrating opioid overdose rates rising from approximately 5 to 10 per 100,000 during this time period).

13 Id. at 4.

14 Edlund, Mark J., The Role of Opioid Prescription in Incident Opioid Abuse and Dependence Among Individuals with Chronic Noncancer Pain: The Role of Opioid Prescription, 30 Clin. J. Pain 557 (2014)Google ScholarPubMed (finding the rate of substance use disorder among pain patients on high dose opioids is roughly 6%); see Volkow, Nora D. & McLellan, A. Thomas, Opioid Abuse in Chronic Pain — Misconceptions and Mitigation Strategies, 374 New Eng. J. Med. 1253 (2016)CrossRefGoogle ScholarPubMed (articulating the need for some patients to remain on opioids, with fewer than 8% of pain patients on opioid pharmacotherapy developing severe substance use disorder).

15 See Am. Psychiatric Assoc., Diagnostic and Statistical Manual of Mental Disorders (5th ed. 2015).

16 Risk of dangerous drug interactions from all-too-frequent concomitant use of opioids in concert with other sedatives like benzodiazepines and alcohol represents another important risk factor. See, e.g., Burris, Scott et al., Stopping an Invisible Epidemic: Legal Issues in the Provision of Naloxone to Prevent Opioid Overdose, 1 Drexel L. Rev. 273, 274-76 (2009)Google Scholar (describing that opioids kill by depressing the individual's central nervous system (“CNS”), which in turn slows respiration. This process can take up to several hours, but is substantially accelerated by the presence of other CNS depressants.) Additionally, returning to drug use after a period of abstinence like incarceration or drug treatment is a major risk factor. When resuming drug use, individuals' overdose risk skyrockets because a loss of tolerance can render a previously therapeutic dose fatal. See Binswanger, Ingrid A., Release from Prison—A High Risk of Death for Former Inmates, 356 New Eng. J. Med. 157, 160-61 (2007)CrossRefGoogle ScholarPubMed (asserting that among Washington State prisoners, overdose mortality risk was elevated 12-fold compared to similar demographic groups within the general population); see also Christensen, Peer B., Mortality Among Danish Drug Users Released from Prison, 2 Int'l J. Prisoner Health 13, 13-19 (2006)CrossRefGoogle Scholar; Farrell, Michael & Marsden, John, Acute Risk of Drug-Related Death Among Newly Released Prisoners in England and Wales, 103 Addiction 251, 252-54 (2007)Google Scholar.

17 Beletsky, Leo et al., Prevention of Fatal Opioid Overdose, 308 JAMA 1863 (2012)CrossRefGoogle ScholarPubMed.

18 See generally Dasgupta, Nabarun et al., Opioid Crisis: No Easy Fix to Its Social and Economic Determinants, 108 Am. J. Pub. Health 182 (2018)CrossRefGoogle ScholarPubMed (describing the numerous factors contributing to the rise in utilization of opioid analgesics over the last two decades).

19 Guy, Gery Jr. et al., Vital Signs: Changes in Opioid Prescribing in the United States, 2006–2015, 66 Morbidity & Mortality Wkly. Rep. 697 (2017)CrossRefGoogle ScholarPubMed.

20 Rachel Lipari & Arthur Hughes, How People Obtain the Prescription Pain Relievers They Misuse, Ctr. for Behav. Health Stat. & Quality Rep. (2017).

21 See Dasgupta, supra note 18 (providing a detailed overview of the three phases of the opioid crisis).

22 Curfman, Gregory D., Abuse-Deterrent Opioids: Benefits, Limitations, and Value, 178 JAMA Int'l Med. 131 (2018)CrossRefGoogle ScholarPubMed.

23 Knopf, Alison, Patients with chronic pain forced into opioid tapers by their prescribers, 30 Alcohol & Drug Abuse Wkly. 1 (2018)Google Scholar; see also Stefan G. Kertesz et al., Opioid Prescription Control: When The Corrective Goes Too Far, Health Aff. Blog (2018).

24 Mendoza, Sonia et al., Shifting Blame: Buprenorphine Prescribers, Addiction Treatment, and Prescription Monitoring in Middle-Class America, 53 Transcultural Psychiatry 465 (2016)CrossRefGoogle ScholarPubMed; see also Beletsky, Leo, Deploying Prescription Drug Monitoring to Address the Overdose Crisis: Ideology Meets Reality, 15 Ind. Health L. Rev. 139 (2018)CrossRefGoogle Scholar.

25 Abby Alpert et al., Supply Side Drug Policy in the Presence of Substitutes: Evidence from the Introduction of Abuse-Deterrent Opioids (Nat'l Bureau of Econ. Research, Working Paper No. 23031, 2017).

26 U.S. Dep't of Just., Georgia Doctor Sentenced To 20 Years In Prison For Operating Pill-Mill Clinics (2014); U.S. Dep't of Just., Another Pill-Mill Doctors Sentenced To Over A Decade In Federal Prison (2014).

27 See Mendoza, supra note 24; see also Beletsky, supra note 24.

28 See infra Part I.B.; see also Larance, Briony, The Effect of a Potentially Tamper-Resistant Oxycodone Formulation on Opioid Use and Harm: Main Findings of the National Opioid Medications Abuse Deterrence (NOMAD) Study, 5 Lancet 155 (2018)Google ScholarPubMed.

29 German Lopez & Sarah Frostenson, How the Opioid Epidemic Became America's Worst Drug Crisis Ever, in 15 Maps and Charts, Vox (Mar. 29, 2017), https://www.vox.com/science-and-health/2017/3/23/14987892/opioid-heroin-epidemic-charts [https://perma.cc/7KC2-KDMR].

30 See Dasgupta et al., supra note 18, at 183.

31 Beletsky, Leo & Davis, Corey, Today's Fentanyl crisis: Prohibition's Iron Law, Revisited, 46 Int'l J. Drug Pol'y 156, 157 (2017)Google ScholarPubMed.

32 See Hedegaard et al., supra note 6, at 1.

33 Id. at 5.

34 Julie K. O'Donnell et al., Trends in Deaths Involving Heroin and Synthetic Opioids Excluding Methadone, and Law Enforcement Drug Product Reports, by Census Region — United States, 2006–2015, 66 Morbidity & Mortality Wkly. Rep. 897, 897 (Sept. 17, 2017).

35 See Dasgupta et al., supra note 18, at 183-184.

36 U.S. Dep't Health & Hum. Servs., Facing Addiction in America: The Surgeon General's Report on Alcohol, Drugs, and Health, 1-3 to 1-25 (2016); see generally Richard J. Bonnie et al., Pain Management and the Opioid Epidemic: Balancing Societal and Individual Benefits and Risks of Prescription Opioid Use (2017) (explaining various treatments for opioid addiction).

37 In a recent poll, 56% of respondents, across all demographics, reported a personal connection to someone who has abused prescription painkillers. Sixty-three percent of White-identifying respondents reported a personal connection, a rate higher than any other racial group. Most Americans Report a Personal Connection to Those Who Have Abused Prescription Painkillers; Whites More Likely to be Affected Than Blacks or Hispanics, Henry J. Kaiser Fam. Found. (Nov. 24, 2015), https://www.kff.org/health-reform/press-release/most-americans-report-a-personal-connection-to-those-who-have-abused-prescription-painkillers-whites-more-likely-to-be-affected-than-blacks-or-hispanics/ [https://perma.cc/S8LP-HKCL].

38 See U.S. Dep't Health & Hum. Servs., supra note 36, at 1-1 (citing statistics that the U.S. ranks 27th in life expectancy).

39 See, e.g., Hauser, Winfried et al., The Opioid Epidemic and the Long-Term Opioid Therapy for Chronic Noncancer Pain Revisited: A Transatlantic Perspective, 6 Pain Mgmt. 249 (2016)CrossRefGoogle ScholarPubMed.

40 Id. Nonetheless, global comparisons are skewed by the reality that many countries lack access to basic medications, even for palliative care. See Berterame, Stefano et al., Use of and Barriers to Access to Opioid Analgesics: A Worldwide, Regional, and National Study, 387 Lancet 1644, 1664 (2016)CrossRefGoogle ScholarPubMed.

41 Teresa Carr, Too Many Meds? America's Love Affair with Prescription Medication, Consumer Reps. (Aug. 3, 2017), https://www.consumerreports.org/prescription-drugs/too-many-meds-americas-love-affair-with-prescription-medication/ [https://perma.cc/B6E5-KUBH].

42 Kolodny, Andrew et al., The Prescription Opioid and Heroin Crisis: A Public Health Approach to an Epidemic of Addiction, 36 Ann. Rev. Pub. Health 559, 662 (2015)CrossRefGoogle Scholar.

43 See Knopf, supra note 23; Kertesz, Stefan G., Turning The Tide or Riptide? The Changing Opioid Epidemic, 38 Substance Abuse 3, 3-5 (2017)CrossRefGoogle ScholarPubMed.

44 See U.S. Dep't Health & Hum. Servs., supra note 36, at 4-21 to 4-22.

45 Id.

46 U.S. Dep't Health & Hum. Servs., supra note 36, at 4-21 (describing the parallel between MAT and insulin in chronic disease management).

47 Id. (describing an extensive evidence base for methadone and buprenorphine treatment); see also Brugal, M. Teresa et al., Evaluating the Impact of Methadone Maintenance Programmes on Mortality Due to Overdose and Aids in a Cohort Of Heroin Users in Spain, 100 Addiction 981, 985-86 (2005)CrossRefGoogle Scholar; Degenhardt, Louisa et al., Mortality Among Regular or Dependent Users of Heroin and Other Opioids: A Systematic Review and Meta-Analysis of Cohort Studies, 106 Addiction 32 (2011)CrossRefGoogle ScholarPubMed; Gibson, Amy et al., Exposure to Opioid Maintenance Treatment Reduces Long-Term Mortality, 103 Addiction 462, 462-63 (2008)CrossRefGoogle ScholarPubMed; Goldstein, Avram & Herrera, James, Heroin Addicts and Methadone Treatment in Albuquerque: A 22-year Follow-Up, 40 Drug & Alcohol Dependence 139, 139-40 (1995)CrossRefGoogle ScholarPubMed; Schwartz, Robert et al., Opioid Agonist Treatments and Heroin Overdose Deaths in Baltimore, Maryland, 1995-2009, 103 Am. J. Pub. Health 917, 921 (2013)CrossRefGoogle Scholar; Sordo, Luis et al., Mortality Risk During and After Opioid Substitution Treatment: Systematic Review and Meta-Analysis of Cohort Studies, 357 Brit. Med. J. 1, 1 (2017)Google ScholarPubMed.

48 Effective Medical Treatment of Opiate Addiction, 15 Nat'l Insts. Health Consensus Statement 1, 21 (Nov. 1997) (recommending that legislator and regulators recognize is cost-effective and constitutes a health benefit).

49 Richard Mattick et al., Methadone Maintenance Therapy Versus No Opioid Replacement Therapy for Opioid Dependence 10-11 (Feb. 1999); see Dolan, Kate A., A Randomized Controlled Trial of Methadone Maintenance Treatment Versus Wait List Controls in an Australian Prison System, 72 Drug & Alcohol Dependence 59, 59-65 (2003)CrossRefGoogle Scholar; Heimer, Robert et al., Methadone Maintenance in Prison: Evaluation of a Pilot Program in Puerto Rico, 83 Drug & Alcohol Dependence 122, 122-29 (2006)CrossRefGoogle ScholarPubMed; Magura, Stephen et al., The Effectiveness of In-Jail Methadone Maintenance, J. Drug Issues 75, 75-97 (1993); Victor Tomasino et al., The Key Extended Entry Program (KEEP): A Methadone Treatment Program for Opioid-Dependent Inmates, 68 Mt. Sinai J. Med. 14, 14-20 (2001)Google Scholar; Volkow, Nora D., Medication-Assisted Therapies — Tackling the Opioid-Overdose Epidemic, 370 N. Eng. J. Med. 2063, 2064-2065 (2014)CrossRefGoogle ScholarPubMed; see also Julia Elitzer & Margaret Tartar, Why Health Plans Should Go to the “MAT” in the Fight Against Opioid Addiction, Cal. Health Care Found. (Sept. 2017), https://www.chcf.org/publication/why-health-plans-should-go-to-the-mat-in-the-fight-against-opioid-addiction/.

50 See U.S. Dep't Health & Hum. Servs., supra note 36, at 4-22; see also Sordo et al., supra note 46, at 1.

51 U.S. Dep't Health & Hum. Servs., supra note 36.

52 See, e.g., Wynne Armand, A Monthly Shot for Opioid Addiction: An Option for Some, Harv. Health Blog (Apr. 1, 2016, 9:05 AM), https://www.health.harvard.edu/blog/a-monthly-shot-for-opioid-addiction-an-option-for-some-201604019364 [https://perma.cc/YLM4-C35Z] (explaining how 36% of a group of people using the treatment succeeded in total abstinence from opioids thus this group were not opioid overdose risk).

53 Powell, Kelly J., Paradoxical Effects of the Opioid Antagonist Naltrexone on Morphine Analgesia, Tolerance, and Reward in Rats, 300 J. Pharmacology & Experimental Therapeutics 588, 588 (2001)CrossRefGoogle Scholar.

54 Lee, Joshua et al., Comparative Effectiveness of Extended-Release Naltrexone Versus Buprenorphine-Naloxone for Opioid Relapse Prevention (X:BOT): A Multicentre, Open-Label, Randomised Controlled Trial, 391 Lancet 309, 313 (2017)Google ScholarPubMed (showing that the intention-to-treat analysis consistently favored buprenorphine-naloxone on all effectiveness endpoints (Table 2) with double the number of overdoses in the naltrexone group as compared with the buprenorphine group); see Elitzer & Tartar, supra note 49, at 7 and Appendix B; see also Brantley P. Jarvis et al., Extended-Release Injectable Naltrexone for Opioid Use Disorder: A Systematic Review, Addiction, Feb. 3, 2018, at 1; Wash. State Inst. for Pub. Policy, Long - Acting Injectable Medications for Alcohol and Opioid Use Disorders: Benefit - Cost Findings Dec 2016 http://www.wsipp.wa.gov/ReportFile/1650/Wsipp_Long-Acting-Injectable-Medications-for-Alcohol-and-Opioid-Use-Disorders-Benefit-Cost-Findings_Report.pdf (demonstrating the drastic cost-effectiveness superiority of methadone and Suboxone® in contrast to Vivitrol®).

55 Beletsky, Leo et al., Fatal Re-Entry: Legal and Programmatic Opportunities to Curb Opioid Overdose Among Individuals Newly Released from Incarceration, 7 Ne. Univ. L.J. 155, 157-59 (2015)Google Scholar (describing the SUD and OD risk parameters of criminally-involved individuals).

56 Michael Stein & Paul Christopher, Opinion, The Problem with Hospitalizing Opioid Addicts Against Their Will, Wash. Post (Oct. 23, 2017), https://www.washingtonpost.com/opinions/the-problem-with-hospitalizing-opioid-addicts-against-their-will/2017/10/23/36bac4de-9fa6-11e7-9c8dcf053ff30921_story.html?noredirect=on&utm_term=.e70b758bacdd [https://perma.cc/ARR5-Z8CC].

57 See Binswanger et al., supra note 16, at 157, 160-61; see also Mass. Dep't Pub. Health, An Assessment of Opioid-Related Deaths in Massachusetts 38 (2016) (estimates post-incarceration risk at 650 times the background rate).

58 Dolan, Kate A., Four-Year Follow-Up of Imprisoned Male Heroin Users and Methadone Treatment: Mortality, Reincarceration, and Hepatitis C Infection, 100 Addiction 820, 820-28 (2005)CrossRefGoogle Scholar; Favrod-Coune, Thierry et al., Opioid Substitution Treatment in Pretrial Prison Detention: A Case Study from Geneva, Switzerland, 143 Swiss Med. Wkly. 1 (2013)Google ScholarPubMed; Kinlock, Timothy W., A Randomized Clinical Trial of Methadone Maintenance for Prisoners: Results at 12 Months Postrelease, 37 J. Substance Abuse Treatment 277, 277-85 (2009)CrossRefGoogle ScholarPubMed.

59 See Libby, Anne M., Mental Health and Substance Abuse Services to Parents of Children Involved with Child Welfare: A Study of Racial and Ethnic Differences for American Indian Parents, 34 Admin. & Pol'y Mental Health 150 (2007)CrossRefGoogle ScholarPubMed.

60 Jose A. Del Real, Opioid Addiction Knows No Color, but Its Treatment Does, N.Y. Times (Jan. 12, 2018), https://www.nytimes.com/2018/01/12/nyregion/opioid-addiction-knows-no-color-but-its-treatment-does.html.

61 See Mathers, Bradley M., Mortality Among People Who Inject Drugs: A Systematic Review and Meta-Analysis, 91 Bull. World Health Org. 102 (2013)CrossRefGoogle ScholarPubMed.

62 Id.; see Moss, Rob & Munt, Brad, Injection Drug Use and Right Sided Endocarditis, 89 Heart 577 (2003)CrossRefGoogle ScholarPubMed.

63 See Zibbell, Jon E., Increases in Acute Hepatitis C Virus Infection Related to a Growing Opioid Epidemic and Associated Injection Drug Use, United States, 2004 to 2014, 108 Am. J. Pub. Health 175 (2018)CrossRefGoogle ScholarPubMed.

64 See Marotta, Phillip & McCullagh, Charlotte, A Cross-National Analysis of the Effects of Methadone Maintenance and Needle and Syringe Program Implementation on Incidence Rates of HIV in Europe from 1995–2011, 32 Int'l J. Drug Pol'y 3 (2016)CrossRefGoogle Scholar.

65 Id.

66 A 2011 study found Veterans Affairs' patients were twice as likely to die of an accidental poisoning than the general U.S. population. See Bohnert, Amy S., Accidental Poisoning Mortality Among Patients in the Department of Veterans Affairs Health System, 49 Med. Care 393 (2011)CrossRefGoogle ScholarPubMed. Veterans with PTSD have also been shown to engage in higher risk opioid use, and have a higher prevalence of adverse clinical outcomes. See Seal, Karen et al., Association of Mental Health Disorders with Prescription Opioids and High-Risk Opioid Use in US Veterans of Iraq and Afghanistan, 307 JAMA 940 (2012)CrossRefGoogle ScholarPubMed.

67 Individuals with chronic pain related to injury are at higher risk for OUD and opioid misuse. See Franklin, Gary et al., Opioid Use for Chronic Low Back Pain: A Prospective, Population-based Study Among Injured Workers in Washington State, 2002-2005, 25 Clinic J. Pain 743 (2009)CrossRefGoogle ScholarPubMed; see also Manchikanti, Laxmaiah et al., Controlled Substance Abuse and Illicit Drug Use in Chronic Pain Patients: An Evaluation of Multiple Variables, 9 Pain Physician 215 (2006)Google ScholarPubMed.

68 There are high rates of comorbidity between substance use disorder and PTSD, particularly OUD. Recent evidence suggests a shared neurobiologic pathway as an explanation for these converging pathophysiological mechanisms. See Brady, Kathleen T., Substance Abuse and Posttraumatic Stress Disorder, 13 Current Directions Psychol. Sci. 206 (2004)CrossRefGoogle Scholar; see also Fareed, Ayman et al., Comorbid Posttraumatic Stress Disorder and Opiate Addiction: A Literature Review, 32 J. Addictive Diseases 168 (2013)CrossRefGoogle ScholarPubMed.

69 In 2016 there were 63,600 overdose deaths from opioids, or 5,300 monthly. See Hedegaard et al., supra note 6. The official death toll from the September 11, 2001 terrorist attacks was 2,977. See September 11th Terror Attacks Fast Facts, CNN (Aug. 24, 2017), https://www.cnn.com/2013/07/27/us/september-11-anniversary-fast-facts/index.html [https://perma.cc/B6WE-2LGU].

70 See U.S. Dep't Health & Hum. Servs., supra note 36.

71 Cathie E. Alderks, Trends in the Use of Methadone, Buprenorphine, and Extended-Release Naltrexone at Substance Abuse Treatment Facilities: 2003-2015 (Update), Ctr. for Behav. Health Stat. & Quality Rep. (2017).

72 Facilities Providing Some Medication Assisted Treatment and Accepting Medicaid, Opioids & Health Indicators Database (2017).

73 Amy Nunn et al., Methadone and Buprenorphine Prescribing and Referral Practices in US Prison Systems: Results from a Nationwide Survey, 105 Drug & Alcohol Dependence 83(2009); see Elitzer & Tartar supra note 49, at 8.

74 Deborah Becker, Is It Addiction Treatment or Prison? A Look Inside a State Center for Involuntary Commitments, WBUR, Sept. 13, 2017, http://www.wbur.org/commonhealth/2017/09/13/civil-commitment-substance-treatment [https://perma.cc/S2HU-NP9E].

75 Marianne Møllmann & Christine Metta, Neither Justice nor Treatment Drug Courts in the United States, Physicians for Hum. Rts. (2017).

76 Andraka-Christou, Barbara, America Needs the TREAT Act: Expanding Access to Effective Medication for Treating Addiction, 26 Health Matrix 308, 322-3 (2016)Google ScholarPubMed.

77 See United States v. Behrman, 258 U.S. 280 (1922); Webb v. United States, 249 U.S. 96 (1919); Jin Fuey Moy v. United States, 241 U.S. 394 (1916); see generally Musto, supra note 11.

78 See Webb, 249 U.S. at 99.

79 Russia has one of the world's most staggering rates of injection drug use with opioids being the predominant drug of choice. Injection-related HIV infections are literally skyrocketing, and life expectancy for men is just 65 years. See Life Expectancy at Birth, Male, World Bank (2015), https://data.worldbank.org/indicator/SP.DYN.LE00.IN [https://perma.cc/JHS4-GTC3].

80 42 C.F.R. § 8.12(j)(4)(i) (2007).

81 Christopher M. Jones et al., National and State Treatment Need and Capacity for Opioid Agonist Medication-Assisted Treatment, 105 Am. J. Pub. Health, e55 (2015).

82 Noska, et al., Managing Opioid Use Disorder During and After Acute Hospitalization: A Case-Based Review Clarifying Methadone Regulation for Acute Care Settings, 4 J. Addictive Behav., Therapy & Rehabilitation 1 (2015)Google ScholarPubMed.

83 See Andraka-Christou supra note 76; see also Kermode, Michelle et al., Opioid Substitution Therapy in Resource Poor Settings, 89 Bull. World Health Org. 243 (2011)CrossRefGoogle ScholarPubMed, http://www.who.int/bulletin/volumes/89/4/11-086850/en/ [https://perma.cc/4PM9-KGEG].

84 See 21 U.SC. § 823(g)(2)(b) (2017) (outlining requirements practitioners must meet in order to dispense narcotic drugs for narcotic treatment).

85 See 21 U.S.C. § 823(g)(iv)(II)(aa) (2017) (“nurse practitioner or physician assistant has completed not fewer than 24 hours of initial training addressing treatment and management of opiate-dependent patients”); Drug Addiction Treatment Act of 2000, Pub. L. No. 106-310, 114 Stat. 1225 (2000).

86 Drug Addiction Treatment Act of 2000, Pub. L. 106-310, 114 Stat. 1223 (2000) (“total number of such patients of the practitioner at any one time will not exceed the applicable number … the applicable number is 30”).

87 21 U.S.C. § 823 (g)(1) (2017); 42 C.F.R § 8.12.

88 See Jones et al., supra note 80, at e59 (showing low opioid treatment Program Operating Capacity by State).

89 See Stein, Bradley et al., Supply of Buprenorphine Waivered Physicians: The Influence of State Policies, 48 J. Substance Abuse Treatment 104, 104 (2015)CrossRefGoogle ScholarPubMed (finding in 2011, 43% of U.S. counties had no buprenorphine-waivered physicians and only 7% had 20 or more waivered physicians).

90 See Jones et al., supra note 80, at e57 (stating that in 48 states and the District of Columbia, only 13 (26.5%) reported 100% of their OTPs were operating at 80% or greater capacity. Another 25 states (51.0%) reported at least 75% of their OTPs were operating at 80% or greater capacity. Wyoming and North Dakota had no OTPs in 2012). See also Elitzer & Tartar supra note 49, at 5 (outlining use of medications in combination with counseling and behavioral therapies for the treatment of substance use disorders).

91 Arthur Robin Williams, Edward Nunes & Mark Olfson, To Battle the Opioid Overdose Epidemic, Deploy the ‘Cascade of Care’ Model, Health Aff. (Mar. 13, 2017), https://www.healthaffairs.org/do/10.1377/hblog20170313.059163/full/ (finding application of quality metrics informed by the Cascade of Care to treatment of opioid use disorder holds great promise to help ensure optimal returns on federal funding for areas hardest hit by overdose).

92 Id.

93 See Bonnie et al., supra note 36.

94 Quinn, Kelly et al., The Relationships of Childhood Trauma and Adulthood Prescription Pain Reliever Misuse and Injection Drug Use, 169 Drug & Alcohol Dependence 190, 191 (2016)CrossRefGoogle ScholarPubMed (finding associations between childhood trauma and PPRM/IDU highlight the need for trauma-informed interventions for drug users and early trauma screening and treatment for prevention of drug misuse over the life course).

95 Missed Opportunity: National Survey of Primary Care Physicians and Patients on Substance Abuse, Colum. Univ. Nat'l Ctr. on Addiction & Substance Abuse ii (2000) (finding failure in the medical profession at every level—in medical school, residency training, continuing education and in practice—to confront the nation's number one disease).

96 Ding, Ling et al., Predictors and Consequences of Negative Physician Attitudes Toward HIV-Infected Injection Drug Users, 165 Archives Internal Med. 618 (2005)CrossRefGoogle ScholarPubMed; see Leo Beletsky et al. Physicians' Knowledge of and Willingness to Prescribe Naloxone to Reverse Accidental Opiate Overdose: Challenges and Opportunities, 84 J. Urb. Health 126 (2007).

97 See Jason Cherkis, Dying to Be Free, Huffington Post (Jan. 28, 2015), http://projects.huffingtonpost.com/dying-to-be-free-heroin-treatment [https://perma.cc/RT57-X2CF] (describing long wait time to enter addiction treatment center).

98 See Colleen Galambos, Health Care: Overview, Encyclopedia Soc. Work (2014), http://socialwork.oxfordre.com/view/10.1093/acrefore/9780199975839.001.0001/acrefore-9780199975839-e-549 [https://perma.cc/EY5J-TJGG] (finding access is uneven in rural areas because hospitals, clinics, and public health facilities are in short supply).

99 Bonnie et al., supra note 36.

100 See U.S. Dep't Health & Hum. Servs., supra note 36, at 1-2 (linking funding to the provision of MAT).

101 Substance Abuse and Mental Health Block Grants, Substance Abuse & Mental Health Servs. Admin. (2016), https://www.samhsa.gov/grants/block-grants [https://perma.cc/HVF4-PSEQ].

102 See Andraka-Christou, supra note 76, at 346 (“Major commercial health insurance covers both treatment components. However, many patients suffering from opioid dependence are low income individuals and, therefore, are less likely to have commercial health insurance than higher-income individuals. Also, many dependent individuals are unemployed, because a circular, causal relationship exists between unemployment and drug dependence.”).

103 See Lindsey Vuolo, Uncovering Coverage Gaps: A Review of Addiction Benefits in ACA Plans, Nat'l Ctr. on Addiction & Substance Abuse (2016), https://www.centeronaddiction.org/addiction-research/reports/uncovering-coverage-gaps-review-of-addiction-benefits-in-aca-plans [https://perma.cc/L5JA-QG7D] (finding not one plan covers every FDA-approved drug to treat opioid addiction. Two-thirds of the plans violate at least one of the ACA's requirements related to the coverage of addiction treatment).

104 Elitzer & Tartar supra note 49, at 7 (finding due to historical fragmentation of coverage, many opioid treatment programs do not accept health insurance, and many commercial plans have difficulty ensuring a network sufficient to meet demand).

105 42 U.S.C § 1396d (1965); see Fiscella, Kevin et al., The Inmate Exception and Reform of Correctional Health Care, 107 Am. J. Pub. Health 84 (2017)CrossRefGoogle ScholarPubMed.

106 See Andraka-Christou, supra note 76, at 346 (enumerating evidence that many patients suffering from OUD are low-income).

107 Advancing Access to Addiction Medications: Implications for Opioid Addiction Treatment, Am. Soc'y Addiction Med. (2013).

108 See Hedegaard et al., supra note 6, at 3 (finding West Virginia was the state with the highest observed age-adjusted drug overdose death rate).

109 Christine Vestal, Still Not Enough Treatment in the Heart of the Opioid Crisis, Pew Charitable Trusts (Sept. 26, 2016), http://www.pewtrusts.org/en/research-and-analysis/blogs/stateline/2016/09/26/still-not-enough-treatment-in-the-heart-of-the-opioid-crisis [https://perma.cc/22KE-RQ9V] (noting that “West Virginia is one of the 17 states where Medicaid does not cover methadone, and it has had an adversarial relationship with methadone clinics for decades. Methadone clinics weren't allowed in the state until 2001, and after nine for-profit clinics set up shop in West Virginia, the Legislature in 2007 placed a moratorium on opening any more.”).

110 Medicaid Coverage of Medications for the Treatment of Opioid Use Disorder, Am. Soc'y Addiction Med. (2014), https://www.asam.org/docs/default-source/advocacy/state-medicaid-reports/state-medicaid-reports_ma.pdf?sfvrsn=6 [https://perma.cc/D9ZM-XJKY].

111 See Advancing Access to Addiction Medications, supra note 107, at 5.

112 See U.S. Dep't Health & Hum. Servs., supra note 36, at 4-23 (noting that far fewer than 10% of US physicians are waivered).

113 Id.; see also Elitzer & Tartar, supra note 49, at 8.

114 See Jones et al., supra note 81, at e57.

115 See Elitzer & Tartar, supra note 49, at 8; see also U.S. Dep't Health & Hum. Servs., supra note 36, at 4-21.

116 See Mendoza, supra note 23, at 474; see also Beletsky, Leo, Using Choice Architecture to Integrate Substance Use Services with Primary Care: Commentary on Donohue et al., 12 J. Addiction Med. 1, 2 (2017)Google Scholar.

117 Id.; see also Elitzer & Tartar, supra note 49, at 8.

118 Olsen, Yngvild & Sharfstein, Joshua M., Confronting the Stigma of Opioid Use Disorder — and Its Treatment, 311 JAMA 1393, 1393-1394 (2014)CrossRefGoogle ScholarPubMed; see Mandiola, Cecelia K., An Exploration of Emergency Physicians' Attitudes Toward Patients with Substance Use Disorder, 12 J. Addiction Med. 132, 135 (2018)Google Scholar.

119 Beletsky et al., supra note 17; see Giglioet, Rebecca E. et al., Effectiveness of Bystander Naloxone Administration and Overdose Education Programs: A Meta-Analysis, 2 Injury Epidemiology 1, 6 (2015)Google Scholar; Wheeler, Eliza et al., Opioid Overdose Prevention Programs Providing Naloxone to Laypersons – United States, 2014, 64 Morbidity & Mortality Wkly. Rep. 631 (2015)Google ScholarPubMed.

120 Coffin, Phillip O. & Sullivan, Sean D., Cost-Effectiveness of Distributing Naloxone to Heroin Users for Lay Overdose Reversal, 158 Annals Internal Med. 1, 5 (2013)CrossRefGoogle ScholarPubMed.

121 See, e.g., Beletsky, supra note 17, at 1-3.

122 See generally Bard, Jennifer S., How the 21st Century Cures Act Can Mitigate the Ever Growing Problem of Mass Incarceration, 44 Am. J.L. & Med. 387 (2018)CrossRefGoogle ScholarPubMed; see generally Evans, Barbara & Ossorio, Pilar, The Challenge of Regulating Clinical Decision Support Software After 21st Century Cures, 44 Am. J.L. & Med. 237 (2018)CrossRefGoogle ScholarPubMed; see generally Halabi, Sam F., Off-Label Marketing's Audiences: The 21st Century Cures Act and the Relaxation of Standards for Evidence-Based Therapeutic and Cost-Comparative Claims, 44 Am. J.L. & Med. 181 (2018)CrossRefGoogle ScholarPubMed; see generally Hall-Lipsy, Elizabeth et al., Practice-Based Research Networks and the Mandate for Real-World Evidence, 44 Am. J.L. & Med. 219 (2018)CrossRefGoogle ScholarPubMed; see generally Hutt, Peter B., The Evolution of Federal Regulation of Human Drugs in the United States: An Historical Essay, 44 Am. J.L. & Med. 403 (2018)CrossRefGoogle Scholar; see generally Kinney, Eleanor D., 21st Century Cures Act and Medical Device Regulation: Departure from Principles or Catching the Wave, 44 Am. J.L. & Med. 269 (2018)CrossRefGoogle ScholarPubMed; see generally Krause, Joan H. & Saver, Richard S., Real-World Evidence in the Real World: Beyond The FDA, 44 Am. J.L. & Med. 161 (2018)CrossRefGoogle Scholar; see generally Orlando, Anthony W. & Rosoff, Arnold J., Fast Forward to the Frightening Future: How the 21st Century Cures Act Accelerates Technological Innovation…at Unknown Risk to Us All, 44 Am. J.L. & Med. 253 (2018)CrossRefGoogle Scholar; see generally Paradise, supra note 1; see generally Riley, Margaret F., A RAT by Another Name: 21st Century Cures Act and Stem Cell Therapies, 44 Am. J.L. & Med. 291 (2018)CrossRefGoogle ScholarPubMed; see generally Schneeweiss, Sebastian & Glynn, Robert J., Real-World Data Analytics Fit for Regulatory Decision-Making, 44 Am. J.L. & Med. 197 (2018)CrossRefGoogle ScholarPubMed; see generally Michael S. Sinha et al., Expansion of the Priority Review Voucher Program Under the 21st Century Cures Act: Implications for Innovation and Public Health, 44 Am. J.L. & Med. 329 (2018); see generally Wolf & Beskow, supra note 2.

123 See Avorn & Kesselheim, supra note 4.

124 Comprehensive Addiction and Recovery Act of 2016, Pub. L. No. 114-198., 130 Stat. 635 (2016).

125 Id.

126 Id.

127 The President himself characterized the high stakes in his address upon the signing of the bill as “I started the 2016 State of the Union address by saying we might be able to surprise some cynics and deliver bipartisan action on the opioid epidemic…. And today, with the 21st Century Cures Act, we are making good ….” Remarks by the President and the Vice President at the 21st Century Cures Act Bill Signing, White House (Dec. 13, 2016, 2:54 PM), https://obamawhitehouse.archives.gov/the-press-office/2016/12/13/remarks-president-and-vice-president-21st-century-cures-act-bill-signing [https://perma.cc/8BD3-VQSC].

128 Id.

129 21st Century Cures Act, Pub. L. No. 114–255, § 1003, 130 Stat. 1033, 1044-1046 (2016).

130 Id. at § 1003(c)(2).

131 Id. at § 1003(c)(1).

132 See Hector Hernandez-Delgado, CARA, the 21st Century Cures Act: More Tools to Address the Opioid Epidemic, Nat'l Health Law Program (Feb. 22, 2017), https://www.napsw.org/assets/docs/Advocacy/caracuresact%202.22.17%201.pdf.

133 21st Century Cures Act § 9003.

134 Id. at § 12001.

135 Id. at § 13001.

136 Id. at § 11003(a)-(b); see also Hernandez-Delgado, supra note 132, at 10 (discussing that previous versions of the legislation sought to substantially reform HIPAA, but were ultimately stripped from the final version of the legislation).

137 21st Century Cures Act §§ 14003(b)-(c), 14004.

138 Id. at §§ 6001(a), 6003(4).

139 See Remarks by the President, supra note 126.

140 Over the three-year period between 2014-2016, SAMHSA provided 28 states with funding through the MAT-PDOA grant, designed to enhance access to MAT. The annualized budget for the program was $11 million. See Targeted Capacity Expansion: Medication Assisted Treatment - Prescription Drug and Opioid Addiction (MAT-PDOA), Substance Abuse & Mental Health Servs. Admin. (2016); In 2016, SAMHSA also awarded 25 states with a SPF-Rx grant, designed to increase prevention programs, community awareness and education, and PDMP data utilization. The initiative's budget was just over $9 million, with a maximum annual award of $371,616, renewable for up to five years. See Strategic Prevention Framework for Prescription Drugs, Substance Abuse & Mental Health Servs. Admin. (2016). SAMHSA also provided $11 million in funding through the prescription drug overdose initiative, designed to reduce overdose death rates. See Grants to Prevent Prescription Drug/Opioid Overdose-Related Deaths, Substance Abuse & Mental Health Servs. Admin. (2016). The Centers for Disease Control and Prevention awarded $28.6 million to 44 states and D.C. for developing prevention and OD tracking strategies. See Press Release, Ctrs. for Disease Control & Prevention, CDC awards [$28.6 million] to help states fight opioid overdose epidemic (2017). SAMHSA does administer the Substance Abuse Prevention and Treatment Block Grants to all 50 states with an annual budget around $1.8 billion. Although clearly much more sizable than the Opioid STR mechanism, this long-standing program includes funding coverage for a wide variety of drug and alcohol-related initiatives, including tobacco.

141 State Targeted Response to the Opioid Crisis Grants, Substance Abuse & Mental Health Servs. Admin. (2016), https://www.samhsa.gov/grants/grant-announcements/ti-17-014 [https://perma.cc/UN3D-J9PA].

142 Id.

143 Id.

144 Substance Abuse & Mental Health Servs. Admin., State Targeted Response to the Opioid Crisis Grants 4 (2017), https://www.samhsa.gov/sites/default/files/grants/pdf/ti-17-014.pdf.

145 Id.

146 Id.

147 Id. at 5.

148 Id. at 3.

149 Id. at 6.

150 Id.

151 Id.

152 Id.

153 Id.

154 Substance Abuse & Mental Health Servs. Admin., Briefing on Substance Use Treatment and Recovery in the U.S. 1 (2016), https://www.samhsa.gov/sites/default/files/partnersforrecovery/docs/Briefing_Substance_Use_Treatment.pdf.

155 Id. at 4. See also Vuolo, supra note 103, at 4 (noting the lax enforcement of ACA's non-discrimination provisions codified in 45 C.F.R. §§ 156.110(d) (2015)); Karen Pollitz et al., Understanding Short-Term Limited Duration Health Insurance, Henry J. Kaiser Fam. Found. (Apr. 23, 2018), https://www.kff.org/health-reform/issue-brief/understanding-short-term-limited-duration-health-insurance/ [https://perma.cc/92CP-NG32] (showing 62% of short-term health insurance plans do not cover substance use disorder services and 43% do not cover mental health services).

156 Substance Abuse & Mental Health Servs. Admin., Targeted Response to the Opioid Crisis Grants (Opioid STR) Individual Grant Awards 1 (2017), https://www.samhsa.gov/sites/default/files/grants/pdf/other/ti-17-014-opioid-str-abstracts.pdf.

157 See State Targeted Response to the Opioid Crisis Grants, supra note 141; see also supra notes 58, 59 and accompanying text.

158 Opioid Overdose Reversal Medication Access and Education Grant Programs, 42 U.S.C. § 290ee-3 (2018) (providing that preference should be given to “states with an incidence or prevalence of opioid use disorders that is substantially higher relative to other states.”).

159 See Casey Leins, New Hampshire: Ground Zero for Opioids, U.S. News (June 28, 2017); N.H. Info. & Analysis Ctr., N.H. Drug Monitoring Initiative (2017), https://www.dhhs.nh.gov/dcbcs/bdas/documents/dmi-2016-overview.pdf.

160 HHS, SAMHSA to Maintain Funding Formula for $1B Opioid Grant Program, Substance Abuse & Mental Health Servs. Admin. (Oct. 30, 2017), https://www.samhsa.gov/newsroom/press-announcements/201710300530 [https://perma.cc/3RPT-8DVM].

161 Federal Opioid Response Fairness of 2017, H.R. 4190, 115th Cong. (2017).

162 State of Ind., 2017 Indiana Integrated Response to the Opioid Crisis Grant Budget Narrative – Year 1 (2017).

163 Id. at 55.

164 Id. at 56.

165 Katie Marks, Kentucky Opioid Response Effort (KORE) Programs, Dep't Behav. Health, Developmental & Intellectual Disabilities (2017).

166 Free Training: COR12 Integrating the Twelve Steps with Medication-Assisted Treatment for Opioid Disorder, St. Elizabeth Training & Educ. Ctr. (Jan. 31, 2018), https://app.cerkl.com/org/story.php?id=1260863 [https://perma.cc/V2SJ-U22F]. Hazelden is an organization with deep roots in the abstinence-based philosophy, an organization that did not recognize the role of MAT in recovery until 2012. See, e.g., Maia Szalavitz, Hazelden Introduces Anti-Addiction Medications into Recovery for First Time, TIME (Nov. 5, 2012), http://healthland.time.com/2012/11/05/hazelden-introduces-antiaddiction-medications-in-recovery-for-first-time/ [https://perma.cc/UNB5-73RD].

167 Some abstinence-based programs claim to be rooted in evidence, based on their inclusion in the National Registry of Evidence-based Programs and Practices (“NREPP”). This controversial program developed to advance gold standard behavioral health science was notoriously reconfigured by amending its inclusion criteria, allowing it to list a number of abstinence-based modalities. For unknown reasons, it was recently shut down by the Trump Administration. See Jessie Hellman, Trump Administration Ends Registry for Substance Abuse, Mental Health Programs, Hill (Jan. 10, 2018), http://thehill.com/policy/healthcare/368404-trump-administration-ends-national-database-for-substance-abuse-mental [https://perma.cc/9MFV-DK38].

168 Marks, supra note 165.

169 Id.

170 Beth Schwartzapfel, Guess Who's Tracking Your Prescription Drugs?, Marshall Project (Aug. 2, 2017), https://www.themarshallproject.org/2017/08/02/guess-whos-tracking-your-prescription-drugs [https://perma.cc/5XM8-28LT]; see also generally Beletsky, supra note 31 (discussing the unintended consequences of PDMP deployment on patient care and help-seeking).

171 STR Opioid Grant Services, Fast Tracker (2018), http://sud.fast-trackermn.org/Home/OpioidGrantServices#.

172 Rule 25 Assessment and Eligibility Process, Dakota Cty. Cmty. Servs. (2011), https://www.co.dakota.mn.us/HealthFamily/ChemicalHealth/ProviderInfo/Documents/Rule25AssessmentEligibilityProcess.pdf.

173 Rule 25 Assessment and Placement Summary, Minn. Dep't Hum. Servs., https://edocs.dhs.state.mn.us/lfserver/Public/DHS-2794-ENG [https://perma.cc/9RJA-7HBR].

174 STR Opioid Grant Services, supra note 171.

175 N.C. Dep't Health & Hum. Servs., Budget Narrative to Address: Substance Abuse and Mental Health Services Administration, CFDA No. TI-17-014, CFDA No. 93.788 (2017).

176 Id.

177 Letter from Anna de Jong, Public Health Advisor, Substance Abuse & Mental Health Servs. Admin, to STR Project Directors and Staff (Dec. 8, 2017) (“We at SAMHSA are very concerned about plans for the potential use of Opioid STR funds for Withdrawal Management, Inpatient, or Residential Services for OUD patients when there is not a definitive commitment and plan of action for the induction of these OUD patients into some form of Medication-Assisted Treatment (MAT) with methadone, buprenorphine, or naltrexone.”).

178 Id. (stating that “it has been strongly communicated to us by Dr. Elinore McCance-Katz, Assistant Secretary for Mental Health and Substance Use, that research has shown that OUD patients who receive only Withdrawal Management, Inpatient, or Residential Services, but who are not inducted into a MAT Program, are at increased risk for relapse, overdose, and death, as compared to patients who are successfully enrolled and maintained in a MAT Program.”).

179 See, e.g., supra notes 162-167 and accompanying text.

180 See U.S. Dep't Health & Hum. Servs., supra note 36; see also Cherkis supra note 97.

181 See generally, Beletsky supra note 31 (outlining the evidence on opioid overdose and other study metrics for PDMP evaluation in Table 1).

182 Id.; see also Substance Abuse & Mental Health Servs. Admin., supra note 144 (listing three separate federal programs with specific funding for PDMPs.) In some cases, PDMPs are also supported by corporate entities, as is the case in Virginia. See Press Release, Purdue Pharm., Purdue Pharma and Commonwealth of Virginia Partner to Improve Utilization of Prescription Monitoring Program (Jan. 26, 2017), http://www.purduepharma.com/news-media/2017/01/purdue-pharma-and-commonwealth-of-virginia-partner-to-improve-utilization-of-prescription-monitoring-program/ [https://perma.cc/95WD-F3MK].

183 See supra note 170 and accompanying text.

184 See supra note 66 and accompanying text.

185 Building on CARA and 21st Century Cures: Envisioning a Comprehensive Response to the Opioid Epidemic, NASTAD (2016), https://www.nastad.org/sites/default/files/resources/docs/building-on-cara-and-21st-century-cures-4.4.17.pdf.

186 Joel Currier, Chesterfield Man's Crusade to Open Drug Task Forces Comes Home, St. Louis Post-Dispatch (Jan. 2, 2018) http://www.stltoday.com/news/local/crime-and-courts/chesterfield-man-s-crusade-to-open-drug-task-forces-comes/article_1b1c74d2-515e-5b1d-8d92-ea34598eae58.html.

187 Aaron Malin, Drug Task Force in Rural Missouri Denies Own Existence, Reason (Nov. 11, 2014) https://reason.com/archives/2014/11/11/secret-drug-task-force-in-rural-missouri [https://perma.cc/7QA3-VVZU].

188 See Beletsky supra note 17.

189 See supra note 52-53 and accompanying text.

190 National Federation of Independent Business v. Sebelius, 567 U.S. 519 (2012).

191 Corwin N. Rhyan, The Potential Societal Benefit of Eliminating Opioid Overdoses, Deaths, and Substance Use Disorders Exceeds $95 Billion Per Year, Altarum (Nov. 16, 2017), https://altarum.org/publications/the-potential-societal-benefit-of-eliminating-the-opioid-crisis-exceeds-95-billion-per-year [https://perma.cc/2GH3-NNBH].

192 Darlene Superville, Trump Signs $700 Billion Military Budget into Law, U.S. News (Dec. 12, 2017, 3:11 PM), https://www.usnews.com/news/business/articles/2017-12-12/trump-signs-700-billion-military-budget-into-law (discussing the military budget).

193 See supra note 35 and 37, and accompanying text.

194 See supra notes 101-2 and accompanying text.

195 Michael Gebelein, Treatment – Not Prison – Alternative for Drug Offenders Faces Funding Questions in NC, Carolina Pub. Press (Jan. 19, 2018), https://carolinapublicpress.org/27586/treatment-not-prison-alternative-for-drug-offenders-faces-funding-questions-in-nc/ [https://perma.cc/RSD5-27QA].

196 Integration Incentive Grants and Cooperative Agreements, 42 U.S.C. § 290bb-42 (2018).

197 Hernandez-Delgado, supra note 132.

198 German Lopez, Congress's Budget Deal Doesn't Do Enough to Fight the Opioid Crisis, Vox (2018), https://www.vox.com/policy-and-politics/2018/2/8/16988236/congress-federal-budget-opioid-crisis.

199 German Lopez, Trump's Budget Could Help Fight the Opioid Crisis—If It Didn't Try to Repeal Obamacare, Vox (Feb. 13, 2018), https://www.vox.com/policy-and-politics/2018/2/13/17004656/trump-budget-opioid-epidemic [https://perma.cc/4QPU-MMCT].

200 Based on Substance Abuse & Mental Health Servs. Admin, supra note 156.