The Feds Are Coming! Session One: The Rules Have Changed
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The opioid crisis in the United States has led to increased enforcement and new legal requirements around opioid prescribing. National overdose deaths have tripled since 1999 and now exceed 64,000 per year. In response, federal agencies like the DEA and FDA have issued new guidelines aimed at curbing opioid prescribing, and state attorneys general are investigating manufacturers and insurers. Healthcare organizations must implement systems to ensure clinicians follow clinical guidelines on safer opioid prescribing practices, risk mitigation strategies, and increased access to alternative treatments and addiction resources. Evidence shows state dosage limit guidelines have successfully reduced overdose deaths without negatively impacting pain treatment.
The Feds Are Coming! Session One: The Rules Have Changed
- 1. Webinar October 17, 2017 The Feds Are Coming! Session 1: The Rules Have Changed Ryan Thurber Polsinelli PC rthurber@polsinelli.com Jeffrey Fitzgerald Polsinelli PC jfitzgerald@polsinelli.com Elizabeth S. Grace, MD, FAAFP Medical Director, CPEP esgrace@cpepdoc.org
- 2. Overdose and Opioids National overdose rate tripled between 1999 and 2015 2016: 64,000 overdose deaths* – Up 22% from 2015 – Estimate that over 2/3 involve prescription opioids Overdose now leading cause of death of American adults under age 50 2.5M Americans struggle with substance abuse disorders Over 200M opioid prescriptions filled each year by US retail pharmacies (2009 - ) Over 1,000 people visit US emergency departments each day for opioid-related emergencies *NY Times, Oct. 8, 2017 p. A16 2
- 3. Enforcement and Blame DEA and DOJ rhetoric is high – Attorney General Jeff Sessions repeatedly discussing • Nevada has 94 prescriptions per 100 residents (July 2017) – New Opioid Detection Unit ($20M plus 12 DOJ attorneys) – Drug manufacturers received subpoenas related to marketing practices – Costco pharmacy paid $11.75M; CVS paid $5M in 2017 State Attorney Generals are being active – 37 State AGs investigating role of health insurance companies – 41 State AGs subpoena Insys for info related to Subsys – Lawsuits against manufacturers to recover Medicaid and other costs (city and county lawsuits too) 3
- 4. Enforcement and Blame Active state legislatures – E.g., Florida Governor proposed limits of prescription to 3 day supply, special regulation of pain clinics Insurers – Cigna won't cover OxyContin in 2018 Class action and mass litigation – Variety of legal theories, mostly against manufacturers All parts of health care industry are being scrutinized 4
- 5. New Legal Requirements and Guidelines Action from a number of interested parties – Centers for Disease Control – FDA – DEA – State Licensing Boards – Professional Associations – State Medicaid Agencies New guidelines cover a spectrum of opioid use – Some are legally binding, some are advisory only – These lists are non-exhaustive 5
- 6. Centers for Disease Control Comprehensive guidelines for opioid prescriptions include 12 key recommendations – Preference for non-pharmacologic/non-opioid treatment – Careful risk analysis and treatment plan – Limitations on dosages – risk thresholds at 50 Morphine Milligram Equivalents (MME) and 90 MME – Ongoing evaluation and patient education regarding risks – Evidence-based treatment for opioid use disorder sufferers www.cdc.gov/mmwr/volumes/65/rr/rr6501e1.htm 6
- 7. Food & Drug Administration FDA “Action Plan” – Recognizes FDA’s role in regulating opioid use throughout the US – Increased emphasis on regulatory oversight and policy development 2016 – draft guidance for development of generic abuse-deterrent opioids Expanded safety warning/labeling requirements Approval of additional naxolone products www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm484714.htm 7
- 8. American Medical Association AMA created an opioid task force in 2014 with numerous other medical associations Recommendations include – Expanded use of PDMPs – Enhancing provider education related to opioid prescribing and related issues – Supporting access to treatment for opioid use disorders and reducing stigma – Expanded access to naxolone through co-prescribing – Encourage safe disposal of opioids www.ama-assn.org/sites/default/files/media-browser/public/physicians/patient-care/opioid-task-force- progress-report.pdf and www.end-opioid-epidemic.org/ 8
- 9. American Academy of Pain Medicine AAPM new position paper (Sept. 21, 2017) – Precautionary prescribing that accounts for individual risk factors – Patient counseling on secure storage and disposal – Use of PDMPs – Systematic patient follow-up from care team – Co-prescription of naloxone – Use of team approaches to care www.painmed.org/files/aapm-scope-of-practice-position-statement.pdf 9
- 10. Colorado Medicaid Phase 1 (eff. August 1, 2017) – “Opioid naïve” beneficiaries are limited to an initial 7 day supply; up to 2 additional refills available (more requires prior authorization) – Additional refills may require consultation with HCPF pain management specialist Phase 2 (eff. October 1, 2017) – Reduction of MME coverage to 250 MME/day – Prescriptions above 250 MME require PA and consult – Limits do not apply to palliative/hospice care or to cancer patients www.colorado.gov/pacific/hcpf/news/colorado-medicaid-tighten-opioid-usage-policy 10
- 11. Colorado Professional Boards Colorado Medical Board, along with the Boards of Nursing, Dentistry, and Pharmacy, published a single opioid policy in 2014 Continuous updates – Most recent stakeholder meeting 8/30/2017 Highlights: – Establish diagnosis and legitimate medical purpose for opioid therapy – Review PDMP and implement appropriate safeguards (e.g., UA) – Doses > 120 MME/day require careful evaluation and documentation – Treatment > 90 days should be carefully evaluated for effectiveness https://www.colorado.gov/pacific/sites/default/files/atoms/files/Policy%20for%20Prescribing%20and%20Dispensing%20Opioids.pdf
- 12. Federation of State Medical Boards Model Policy on Use of Opioids for Chronic Pain – Understanding pain – Patient evaluation and risk stratification – Documented treatment goals – Informed consent and treatment agreements – Initiation of opioid therapy on trial basis – Ongoing monitoring – Drug testing – Criteria for referral to specialist – Discontinuation practices 12 http://www.fsmb.org/Media/Default/PDF/FSMB/Advocacy/pain_policy_july2013.pdf
- 13. Changing Practice Standards: The Physician’s View 13
- 15. Chronic Opioid Therapy “Evidence is insufficient to determine the effectiveness of LT opioid therapy for improving chronic pain and function. Evidence supports a dose-dependent risk for serious harms.” Chou R, Turner JA, Devine EB, Hansen RN, Sullivan SD, Blazina I, et al. The Effectiveness and Risks of Long-Term Opioid Therapy for Chronic Pain: A Systematic Review for a National Institutes of Health Pathways to Prevention Workshop. Ann Intern Med. 2015;162:276–286. doi: 10.7326/M14-2559 15
- 16. Chronic Opioid Therapy Harm – Myocardial infarction – Fractures – Endocrine effects/markers of sexual dysfunction – Sleep apnea – Arrhythmias and sudden death (methadone) – Abuse, dependence, OD
- 17. Harms - Opioid abuse or dependence with chronic (>90 d) use: • 0.004% (no opioid therapy) • 0.7% w low dose (MED 1-36) (Adjusted OR 14.9) • 6.1% w high dose (MED > or = 120) (Adjusted OR 122.5) Eklund as referenced in: Chou R, Turner JA, Devine EB, Hansen RN, Sullivan SD, Blazina I, et al. The Effectiveness and Risks of Long-Term Opioid Therapy for Chronic Pain: A Systematic Review for a National Institutes of Health Pathways to Prevention Workshop. Ann Intern Med. 2015;162:276– 286. doi: 10.7326/M14-2559 Chronic Opioid Therapy 17
- 18. Harms - Overdose: • Adjusted hazard ratio (compared to low dose (1- 19 MED) (Dunn) – 1.44 for MED 20-49 – 8.87 for MED ≥ 100 • Adjusted odds ratio (compared to low dose (1-19 MED) (Gomes) – 1.32 for MED 20-49 – 2.88 for MED ≥ 200 Chou R, Turner JA, Devine EB, Hansen RN, Sullivan SD, Blazina I, et al. The Effectiveness and Risks of Long-Term Opioid Therapy for Chronic Pain: A Systematic Review for a National Institutes of Health Pathways to Prevention Workshop. Ann Intern Med. 2015;162:276–286. doi: 10.7326/M14-2559 Chronic Opioid Therapy 18
- 20. Other Factors Opioid misuse in youth Epidemiology of ODs involving concurrent opioid and benzodiazepine use
- 21. Foster an environment where clinical guidelines are seen and used as practice supports, not practice constraints Education: institution-wide – Clinicians: • Safe prescribing, guidelines, rationale • Non-pharmacologic and non-opioid treatments • If possible, include situation-specific recommendations – Patients: appropriate expectations Putting Guidelines into Practice: Organizational Perspective 21 Meeker et al. Effects of behavioral Interventions on Inappropriate Antibiotic Prescribing Among Primary Care Practices. JAMA. 2016;315(6):562-570 Hill MV et al. An Educational Intervention Decreases Opioid Prescribing After General Surgical Operations. Ann Surg 2017 PAP Scully RE et al. Defining Optimal Length of Opioid Pain Medication Prescription After Common surgical Procedures. JAMA Surgery. JAMA Surg. doi:10.1001/jamasurg.2017.3132. Published online September 27, 2017.
- 22. “As every doctor knows, nothing cuts short a patient visit like a prescription pad.” — Sam Quinones Dreamland 22
- 23. Putting Guidelines into Practice: Organizational Perspective Practice Support: – Time: ensure adequate time for clinicians to manage these complicated patients – Technology: • Special applications that assist in managing and monitoring patients • PDMP integration – Referral resources: ensure adequate referral resources for your clinicians • PT, modalities, counseling, addiction medicine, others 23
- 24. Putting Guidelines into Practice: Organizational Perspective Systems and protocols that increase clinician efficiency – Patient evaluation: initially and periodically • Assessment of risk and function • Depression and anxiety screening • Screening for addiction – Treatment planning and risk mitigation • Patient agreements with periodic updating • PDMP checks: initially and at least every 3 months; establish delegates, as permitted • UDT: initially and at least annually (frequency commensurate with risk) • Naloxone (Narcan) prescribing 24
- 25. Putting Guidelines into Practice: Organizational Perspective Systems and protocols that increase clinician efficiency (continued) – Patient education: • Expectations • Risks, benefits, alternatives • Safe use, storage and disposal – Documentation* • Means to easily document best practices in EMR • Cues to include clinical rationale, especially when prescribing outside of guidelines 25
- 26. The only thing that is constant is change. - Heraclitis (535-475 BC) Putting Guidelines into Practice: Organizational Perspective 26
- 27. Washington State Opioid Dosing Guideline implemented in 2007 – Decline in MED of schedule II drugs by 27% – 35% decrease in the number of patients receiving ≥ 120 MED – 50% decrease in opioid-related deaths Franklin, G. M., Mai, J., Turner, J., Sullivan, M., Wickizer, T., & Fulton-Kehoe, D. (2012). Bending the prescription opioid dosing and mortality curves: Impact of the Washington State opioid dosing guideline. American Journal of Industrial Medicine, 55(4), 325-331. DOI: 10.1002/ajim.21998 Evidence That Guidelines Work 27
- 28. Polsinelli provides this material for informational purposes only. The material provided herein is general and is not intended to be legal advice. Nothing herein should be relied upon or used without consulting a lawyer to consider your specific circumstances, possible changes to applicable laws, rules and regulations and other legal issues. Receipt of this material does not establish an attorney-client relationship. Polsinelli is very proud of the results we obtain for our clients, but you should know that past results do not guarantee future results; that every case is different and must be judged on its own merits; and that the choice of a lawyer is an important decision and should not be based solely upon advertisements. © 2016 Polsinelli PC. In California, Polsinelli LLP. Polsinelli is a registered trademark of Polsinelli PC. 28 60703969
- 29. Webinar October 17, 2017 The Feds Are Coming! Session 1: The Rules Have Changed Ryan Thurber Polsinelli PC rthurber@polsinelli.com Jeffrey Fitzgerald Polsinelli PC jfitzgerald@polsinelli.com Elizabeth S. Grace, MD, FAAFP Medical Director, CPEP esgrace@cpepdoc.org