What's in a number? Recommending practicality in the DATA 2000 patient limits

Andrea G. Barthwell, MD, DFASAM; Jonathan M. Young, JD, PhD; Michael C. Barnes, JD; Shruti R. Kulkarni, JD

doi:10.5055/jom.2016.0339

Authors

Andrea G. Barthwell, MD, DFASAM
Jonathan M. Young, JD, PhD
Michael C. Barnes, JD
Shruti R. Kulkarni, JD

DOI:

https://doi.org/10.5055/jom.2016.0339

Keywords:

Opioid use disorder, medication-assisted treatment, buprenorphine, DATA 2000

Abstract

According to the Substance Abuse and Mental Health Services Administration, 2.4 million individuals have an opioid use disorder (OUD). Yet, nearly 80 percent of them—more than 1.9 million people—do not receive treatment. Medication-assisted treatment (MAT), specifically with buprenorphine, has proven to be effective in treating patients with OUDs while also reducing costs to the healthcare system, criminal justice system, and workforce. Despite its effectiveness, barriers to MAT continue to exist. Consequently, many individuals must wait months, if not years, to receive treatment. This article analyzes the US Department of Health and Human Services’ final rule (Final Rule) on MAT, common barriers to treatment, and the cost-benefit of treatment in light of the current opioid abuse epidemic. The article finds that while the Final Rule was a step in the right direction, it does not go far enough to adequately address the epidemic. Finally, the article proposes practical recommendations for increasing patient access to treatment for OUDs, including increasing the patient limit for highly qualified addiction treatment providers so that they can practice addiction medicine on a full-time basis and exempting buprenorphine products labeled by the US Food and Drug Administration for direct administration from the practitioner's patient limit.

Author Biographies

Andrea G. Barthwell, MD, DFASAM

Partner, EMGlobal LLC, Chicago, Illinois; Medical Director, Encounter Medical Group, PC, Chicago, Illinois; Manager, Treatment Partners LLC, Chicago, Illinois

Jonathan M. Young, JD, PhD

General Counsel and Vice President, Policy and Advocacy, Braeburn Pharmaceuticals, Princeton, New Jersey

Michael C. Barnes, JD

Managing Partner, DCBA Law & Policy, Washington, DC

Shruti R. Kulkarni, JD

Associate Attorney, DCBA Law & Policy, Washington, DC

References

Department of Health and Human Services: Medication assisted treatment for opioid use disorders, Final rule. 81 F.R. 44711. 2016: 44,711-44,739. Available at https://www.federalregister.gov/articles/2016/07/08/2016-16120/medication-assistedtreatment-for-opioid-use-disorders. Accessed August 16, 2016.

Hedegaard H, Chen LH, Warner M: Drug-Poisoning Deaths Involving Opioid Analgesics: United States, 1999-2011. NCHS Data Brief 166. Hyattsville, MD: National Center for Health Statistics, 2014. Available at http://www.cdc.gov/nchs/data/databriefs/db190.pdf. Accessed August 16, 2016.

Levi J, Segal, LM, Martín A: The Facts Hurt: A State-by-State Injury Prevention Policy Report. Washington, DC: Trust for America's Health, 2015. Available at http://healthyamericans.org/assets/files/TFAH-2015-InjuryRpt-final6.18.pdf. Accessed August 16, 2016.

Centers for Disease Control and Prevention, National Center for Health Statistics, National Vital Statistics System: Mortality File: Number and Age-Adjusted Rates of Drug Poisoning Deaths Involving Opioid Analgesics and Heroin: United States, 2000- 2014. Atlanta, GA: Centers for Disease Control and Prevention, 2015. Available at http://www.cdc.gov/nchs/data/health_policy/AADR_drug_poisoning_involving_OA_Heroin_US_2000-2014.pdf. Accessed August 16, 2016.

Dart R: Diverging Perspectives of Prescription Opioid Abuse. RADARS® System 2015 Data Updates. Available at http://www.radars.org/Portals/1/AnnualMeeting/2016/RADARS%20System%202016%20Annual%20Meeting_Dart1.pdf?ver=2016-05-17-102942-940&timestamp=1463505251899. Accessed August 16, 2016.

Botticelli MP: Assessing the Federal Response to Drug and Opioid Use. Washington, DC: Senate Homeland Security and Governmental Affairs Committee, 2016. Available at www.hsgac.senate.gov/download/testimony-botticelli-2016-05-17. Accessed August, 16, 2016..

Substance Abuse and Mental Health Services Administration: Briefing on Substance Use Treatment and Recovery in the United States. Washington, DC: US Department of Health and Human Services. Available at http://www.samhsa.gov/sites/default/files/partnersforrecovery/docs/Briefing_Substance_Use_Treatment.pdf. Accessed August 16, 2016.

Johns Hopkins Bloomberg School of Public Health: Number of Addicted Rises, but Shortage in Drug Treatment Remains Stagnant. Science Daily. October 13, 2015. https://www.sciencedaily.com/releases/2015/10/151013133407.htm. Accessed August 16, 2016.

Volkow ND: Prescription Opioid and Heroin Abuse. Bethesda, MD: National Institute on Drug Abuse, 2014. Available at https://www.drugabuse.gov/about-nida/legislative-activities/testimonyto-congress/2015/prescription-opioid-heroin-abuse. Accessed August 16, 2016.

Substance Abuse and Mental Health Services: The Facts About Buprenorphine For Treatment Of Opioid Addiction. Washington, DC: US Department of Health and Human Services, Revised 2011.

National Institute on Drug Abuse: Drugs, Brains, and Behavior: The Science of Addiction. Bethesda, MD: National Institute on Drug Abuse, 2014. Available at https://www.drugabuse.gov/sites/default/files/soa_2014.pdf. Accessed August 16, 2016.

Friedman S, Wagner-Goldstein K: Medication-Assisted Treatment in Drug Courts: Recommended Strategies. New York, NY: Center for Court Innovation 2015: 7. Available at http://www.courtinnovation.org/sites/default/files/documents/MATindrugCourtsFinal.pdf. Accessed August 16, 2016.

Substance Abuse and Mental Health Services Administration: Medication-Assisted Treatment for Opioid Addiction: Facts for Families and Friends. Washington, DC: US Department of Health and Human Services.

McNicholas L: Clinical Guidelines for the Use of Buprenorphine in the Treatment of Opioid Addiction: TIP 40. Rockville, MD: Substance Abuse and Mental Health Services Administration, 2004.

Arfken CL, Johanson CE, Menza SD, et al: Expanding treatment capacity for opioid dependence with office-based treatment with buprenorphine: National surveys of physicians. J Subst Abuse Treat. 2010; 39(2): 96-104.

Controlled Substances Act, 21 USC §823(g) (2000). 17. Available at https://www.justice.gov/archive/ndic/pubs10/10123/index.htm. Accessed August 16, 2016.

Hearing Before the Subcommittee on Health and Environment of the Committee on Commerce House of Representatives.106th Cong. 1st Sess (1999). Available at https://www.gpo.gov/fdsys/pkg/CHRG-106hhrg58503/html/CHRG-106hhrg58503.htm. Accessed August 16, 2016.

Lavonas EJ, Severtson SG, Martinez EM, et al.: Abuse and diversion of buprenorphine sublingual tablets and film. J Subst Abuse Treat. 2014; 47(1): 27-34.

Vestal C: Waiting lists grow for medicine to fight opioid addiction. The Huffington Post. 11 February, 2016. http://www.huffingtonpost.com/entry/opioid-addiction-treatment_us_56bcb1a5e4b08ffac1241b63. Accessed August 16, 2016.

Hearings Before the Subcommittee on Health of the Energy and Commerce Committee. 114th Cong, 1st Sess (2015) (testimony of Robert Corey Waller, MD, MS).

ClinicalTrials.gov: Treatment seeking participants with opioid use disorders assessing tolerability of depot injections of buprenorphine. 2016. Available at https://clinicaltrials.gov/. Accessed August 16, 2016.

ClinicalTrials.gov: Clinical trial of CAM2038, long-acting subcutaneous buprenorphine injections for treatment of patients with opioid dependence. 2016. Available at https://clinicaltrials.gov/. Accessed August 16, 2016.

BioDelivery Sciences International, Inc.: BioDelivery sciences to develop a long-acting injectable depot formulation of buprenorphine with evonik for use in opioid dependence and pain. 2014. Available at http://www.prnewswire.com/news-releases/biodelivery-sciences-to-develop-a-long-acting-injectable-depot-formulation-of-buprenorphine-with-evonik-for-use-in-opioid-dependence-and-pain-280628052.html. Accessed August 16, 2016.

Rosenthal RN, Lofwall MR, Kim S, et al.: Effect of buprenorphine implants on illicit opioid use among abstinent adults with opioid dependence treated with sublingual buprenorphine: A randomized clinical trial. JAMA. 2016; 316(3): 282-290.

Fisher M: Long waiting lists for drug treatment add to addicts’ desperation. Washington Post. July 26, 2015. Available at https://www.washingtonpost.com/politics/long-waiting-listsfor-drug-treatment-add-to-addicts-desperation/2015/07/26/d8e8e2b2-13ae-11e5-9518-f9e0a8959f32_story.html. Accessed August 16, 2016.

SAMHSA: Physician and Program Data. Rockville, MD: Substance Abuse and Mental Health Services Administration. Available at http://www.samhsa.gov/programs-campaigns/medication-assisted-treatment/physician-program-data. Accessed August 16, 2016.

Jennifer L: BioDelivery Sciences Receives FDA Approval for BUNAVAIL™ (buprenorphine and naloxone) Buccal Film for the Maintenance Treatment of Opioid Dependence (citing data from Symphony Health Solutions). Fierce Biotech. June 9, 2014. Available at http://www.fiercebiotech.com/biotech/biodeliverysciences-receives-fda-approval-for-bunavail-tm-buprenorphineand-naloxone. Accessed August 16, 2016.

Substance Abuse and Mental Health Services Association: Emerging issues in behavioral health and criminal justice system. 2015. Available at http://www.samhsa.gov/criminaljuvenile-justice/behavioral-health-criminal-justice. Accessed August 16, 2016.

Birnbaum HG, White AG, Schiller M, et al.: Societal costs of prescription opioid abuse, dependence, and misuse in the United States. Pain Med. 2011; 12(4): 657-667.

Regulations.gov: Cigna letter to the Substance Abuse and Mental Health Services Administration and Department of Health and Human Services regarding medication assisted treatment for opioid use disorders. May 31, 2016. Available at https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&s=Cigna&dct=PS&D=SAMHSA-2016-0001. Accessed August 16, 2016.

Center for Substance Abuse Treatment, Substance Abuse and Mental Health Services Administration, US Department of Health and Human Services: The cost offset of treatment services. 2009. Available at https://samhsa-gpra.samhsa.gov/CSAT/view/docs/SAIS_GPRA_CostOffsetSubstanceAbuse.pdf. Accessed August 16, 2016.

Department of Health and Human Services: Medication assisted treatment for opioid use disorders, Final rule. 81 F.R. 44711. 2016: 44733. Available at https://www.federalregister.gov/articles/2016/07/08/2016-16120/medication-assisted-treatment-for-opioid-use-disorders. Accessed August 16, 2016.

Department of Health and Human Services: Medication assisted treatment for opioid use disorders, Final rule. 81 F.R. 44711. 2016: 44729. Available at https://www.federalregister.gov/articles/2016/07/08/2016-16120/medication-assisted-treatment-for-opioid-use-disorders. Accessed August 16, 2016.

Department of Health and Human Services: Medication assisted treatment for opioid use disorders, Final rule. 81 F.R. 44711. 2016: 44729-44734. Available at https://www.federalregister.gov/articles/2016/07/08/2016-16120/medication-assistedtreatment-for-opioid-use-disorders. Accessed August 16, 2016.