Addressing an Evolving Epidemic Through Substance Use Intervention and Treatment Policies*

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1 IntNSA 38 th Annual Educa3onal Conference Washington, DC October 16, 2014 Addressing an Evolving Epidemic Through Substance Use Intervention and Treatment Policies* Michael C. Barnes, Execu3ve Director, CLAAD Stacey L. Worthy, Associate A=orney, DCBA Law & Policy

2 Con%lict of Interest Disclosure* The Center for Lawful Access and Abuse Deterrence (CLAAD) receives funding from businesses in the health care industry that share CLAAD s mission to reduce prescrip3on drug fraud, diversion, misuse, and abuse while advancing consumer access to high- quality health care. CLAAD s funders include pharmaceu3cal companies, treatment centers, and laboratories, and are disclosed on its website, CLAAD is managed by DCBA Law & Policy. DCBA also provides legal and policy counsel to professionals and businesses whose ac3vi3es align with CLAAD s mission. To avoid conflicts of interest, DCBA adheres to the District of Columbia Rules of Professional Conduct

3 Preview* Introduc3on Responses to Opioid Abuse Shi]s in Supply Addressing Demand Percep3ons of Health Risks Treatment of Substance Use Disorders Therapeu3c Approach Crucial Role of Nurses Need for Advocacy Conclusion

4 Introduction* Mission Lawful access: consumer access to high- quality health care Abuse deterrence: preven3ng fraud, diversion, and abuse Informa3on and analysis Modera3on Policy leadership (governmental, corporate, professional) Coali3on building (resource sharing and harmoniza3on of efforts)

5 Rx Abuse: Are We Making Progress?

6 Federal Responses LA/ER opioid REMS (voluntary educa3on) Secure and Responsible Drug Disposal Act (effec3ve 10/9/14) Grant support (PMPs, research) Abuse- deterrent opioids (proposed federal legisla3on) New opioid labels ( severe enough ) Prosecu3ons and DEA enforcement (distributors, pharmacies) Hydrocodone rescheduling FDA approved naloxone auto- injector

7 State Responses to Opioid Abuse Mandatory PMP data checks Mandatory prescriber educa3on all controlled substances Good Samaritan, naloxone laws first responders, Rx Pain clinic registra3on and regula3on Safer prescribing and abuse- preven3on standards Successful prosecu3ons Second- degree murder (knowing indifference to consequence) Involuntary manslaughter (harmful ac3vity w/o due cau3on)

8 Corporate Responses to Opioid Abuse* Pharmaceu3cal research and development Pain Addic3on Tes3ng for substance use Pharmacogene3c risk More defini3ve urine tes3ng w/ greater sensi3vity, specificity, accuracy and reliability (not yet implemented in sports) Locking devices Insurer data analysis and alerts

9 Rx Abuse: Progress in Reducing Supply Opioid overdose deaths fall 5% and all Rx overdose deaths fall 3% na3onally (CDC - 10/15/14) Prescrip3on drug deaths falling across FL (10/14/13) Na3onal survey shows reduced levels of Rx abuse among young adults (9/4/13) KY sees decline in drug overdose deaths, including Rx overdose (8/8/13) Opioid medica3on abuse down in 10 states (KY, LA, MA, MS, NH, NY, OH, OK, RI, WV) (1/8/13) Abuse- deterrent medica3ons can reduce the risk of diversion, misuse, and abuse (July 2012)

10 Evolution of the Epidemic* Heroin use and buprenorphine misuse Decreasing supply of Rx medica3ons available for abuse w/o corresponding demand reduc3ons Raiding before regula3ng leads to denials of Rx medica3ons for people with pain and SUDs Distributors, pharmacies MAT prescribers FedEx Neonatal abs3nence syndrome S3mulant and benzodiazepine abuse Availability of marijuana and new substances

11 Diminished Perceptions of Health Risks* Alcohol: present in the household; a rite of passage Opioids, s3mulants, and benzodiazepines: prescribed by a professional, available at a pharmacy Marijuana: medicine and recrea3on ( safer than sugar ) Synthe3cs: available at malls, convenience stores, and online Analogs and counterfeits: same drug, slightly modified formula3on, package, or language; available online E- cigare=es: clean delivery of nico3ne, THC, and opioids 3D prin3ng: ordered online and printed at home

12 SUD Treatment Need: Big Picture 21.6 million Americans with SUDs 89.6 percent untreated 33,071 unintended overdose deaths in ,810 involved prescrip3on drugs S3gma Social Structural

13 More Therapeutic, Less Punitive Approach* ACA & Equity Act expand access to treatment Educate consumers Challenge insurance denials Acceptance of medica3on- assisted treatment Drug courts reduce costs and recidivism Expansion of interven3ons and referrals to treatment Non- puni3ve tes3ng for substance use (improving in Medicare) Health care (primary, emergency, prenatal, psychiatry, addic3on) Educa3on, employment, criminal jus3ce systems Kick up, not out Sentencing reform and vo3ng- rights restora3on

14 Enforcing Equity and Parity On August 8, 2014, MA passed a law manda%ng insurers to cover up to two weeks of inpa3ent detoxifica3on and post- detox rehab. PA law upheld in 2009 requires coverage of up to 7 days of detox per year and 28 days per life3me; minimum of 30 days non- hospital residen3al rehabilita3on per year 90 days per life3me; and a minimum of 30 full session visits of outpa3ent or equal par3al hospitaliza3on visits per year 120 visits per life3me. Kaiser Permanente se=led with California for $4 million viola3ng the state parity laws.

15 Crucial Role of Nurses* Lead the implementa3on of best prac3ces in merging fields of pain and addic3on medicine Educate and advocate for coverage under ACA, Equity Act Tremendous preven3on and interven3on resource Watchdog and whistleblower Touch every community and family Passion and credibility on issues Professional associa3ons like IntNSA wield influence Break stereotypes and s3gma Improve macro- level policies and prac3ces

16 Need for Advocacy: Improve Balance in Policy Jailing moms and seizing newborns in response to NAS Barriers to access Ac3ons against controlled substance registrants, with consequences affec3ng pa3ents Limits on MAT Denials of care, turning away from treatment Restric3ve policies Unfair prac3ces (complaints and appeals) Prescrip3on monitoring program data breaches

17 Need for Advocacy: Federal Supremacy* Ballot measures and legisla3on Importa3on of non- FDA- approved drugs Specific medica3on bans: what s next? City- and county- level interference The Best of Both Worlds: Applying Federal Commerce and State Police Powers To Reduce PrescripBon Drug Abuse. MD. J. HEALTH CARE L. & POL Y (2013).

18 Federal Measures Under Consideration Raise buprenorphine pa3ent limit (Markey bill) Expand buprenorphine prescribing to NPs, PAs Require PMP repor3ng of dispensing for MAT pa3ents (42 CFR Part 2 at issue) H.R. 4709/S.2862 (regulate before raid)

19 Policy Resources (since May 29, 2014) Blowing the Whistle on Dirty Docs Overdose Preven3on Act (warm hand- off) legisla3ve proposal Le=er of support for H.R (regulate before raiding) Safer Opioid Prescribing and Abuse Preven3on Standards for Pain Management Principles for Urine Drug Tes3ng in Addic3on Medicine Prac33oners May Not Profiteer from Drug Tes3ng ACLU s Lawsuit Exemplifies Confusion Regarding Therapeu3c Tes3ng for Substance Use

20 Law Review Articles Applying Lessons from the Opioid Abuse Epidemic to Protect Consumers from Gray Market Biologics, NOTRE DAME J.L. ETHICS & PUB. POL Y (Forthcoming 2014). Achieving Real Parity: Increasing Access to Treatment for Substance Use Disorders Under the PaBent ProtecBon and Affordable Care Act and the Mental Health Parity and AddicBon Equity Act, U. Ark. Li=le Rock L. Rev. (Forthcoming 2014). AcBve VerificaBon and Vigilance: A Method To Avoid Civil and Criminal Liability When Prescribing Controlled Substances, 15 DEPAUL J. HEALTH CARE L. 93 (2013). The Best of Both Worlds: Applying Federal Commerce and State Police Powers To Reduce PrescripBon Drug Abuse. MD. J. HEALTH CARE L. & POL Y (2013).

21 Conclusion* LinkedIn.com/in/michaelcbarnes CLAAD.org LinkedIn.com/in/staceyworthy DCBALaw.com Thank You Ques3ons and Discussion

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