Current Events in Law and Public Policy

Current Events in Law and Public Policy Implications for Pain Care Practitioners Michael C. Barnes, Esq.

Disclosure Information  No relevant personal financial relationships

Learning Objectives  Describe the importance of following standards of care, as identified by certified experts, in limiting criminal and civil liability.  Explain why improving prescriber education is a vital next step toward reducing prescription drug abuse as well as improving pain care.  Identify legislative and regulatory trends and how they could impact pain care practitioners and patients.

Preview  News headlines  Criminal prosecutions  Federal legislative activity  Federal regulatory activity  State activity  Insurer activity

Top Headline  Affordable Care Act validated – More people, more conditions covered • Substance abuse • Hospice not an EHB

– Gov’t, insurance cos. set rules affecting practice

Headlines→Public Awareness  Death of Whitney Houston  Drug deaths outnumber traffic fatalities  Stimulant, benzodiazepine abuse highlighted – Academic doping – Mixing with alcohol – ED visits on the rise

 Opioid-dependent newborns  Abusers turn to heroin as Rx supply tightens

Headlines (Only) We Noticed  CVS refuses to fill some prescriptions in FL  Cos. seek to market pure hydrocodone  Abusers lose interest in reformulated opioids  Courts, FDA to determine when, how generic OxyContin to come to market  Untreated pain, opioid abuse cost $323 billion  IOM report corrected

Headline Highlighting Quandary  Middle school students suspended for sharing asthma inhaler (in emergency)

Criminal Prosecutions: Prescribers  Conrad Murray, M.D. – Guilty of involuntary manslaughter (high-risk activity without due caution) – 17 egregious deviations from standard of care

 Lisa Tseng, D.O. – Second-degree murder (indifference to consequence) – “If one of my patients decides to take a month's supply in a day, then there is nothing I can do about that.”

Criminal Prosecutions: Pill Mills  George twins, largest pill mill – Net $235 per 180-count prescription filled on site – Paid doctors up to $100 per prescription – 18-year sentence

 Pill Mill Vinny – $150K per day in oxycodone business – 20-year sentence

Federal Legislative Activity, 1/2  Mandatory prescriber education – Rockefeller (S. 507), Rahall (H.R. 1925) – Bono Mack (H.R. 2119)

 Hydrocodone rescheduling – defeated  Keating: opioids to be abuse-deterrent  Investigation of pain groups for industry ties

Federal Legislative Activity, 2/2  Kohl: Nursing Home Pain Relief Act (S. 1560): oral prescriptions  ID MEDS Act (H.R. 4292): interstate PMP data sharing  Schumer: SAFE DOSES Act: criminal Rx drug rings (S. 1002)

Federal Regulatory Activity  Controlled substance distributors (Cardinal Health, Walgreens, CVS) – Judge: distributors must self-police – Settlement: more frequent pharmacy inspections

 FDA meeting: more evidence needed to support long-term opioid use for chronic pain  Hydrocodone rescheduling – FDA Advisory Committee meeting Oct. 29-30 – DEA since 1999

 LA/ER opioid REMS (voluntary education)

Federal Regulatory Inactivity  FDA, NIH “prioritize” abuse-deterrent, non-opioid pain relievers  Industry: FDA, DEA fail to provide meaningful guidance  Still no consumer drug disposal regulations (Safe and Secure Drug Disposal Act of 2010)

State Activity  FL judge: if you use oxycodone, do not drive  Pill mill restrictions (TN; FL oxycodone sales fall 20%)  PMPs (49 states) – Mandatory data checks (KY law, TN law, NY bill) – HHS-funded pilot to merge data into EHR (OH, IN)

 Continuing ed mandates (MA, DE)  ID req’d to fill Sched. II, III prescriptions (NC)  Voluntary guidelines in EDs (OH)

Insurer Activity  Workers Comp approved for opioid-related death  MABCBS: pre-authorization for opioids  Aetna automated alerts to prescribers  Express Scripts: anti-fraud program  Accident Fund Holdings: peer-to-peer intervention  GAO Medicare report (170,000 suspicious cases)  Medicaid safeguards against Rx abuse (TN)

Trends  Greater attention to Rx abuse (not just opioids)  Pain groups losing funding; pain care advocacy weakening  Pain, addiction care more intertwined  Prescribers self-sorting (no excuse for negligence)  Make-or-break moment for abuse-deterrent medications  Focus on mandatory prescriber education (little impact on diligent prescribers)

Conclusion  Q&A, Discussion  CLAAD Policy Brief  LinkedIn: Michael C. Barnes  Twitter: @mcbtweets, @dcbalaw  Thank you