the feds are coming! session one: the rules have changed
TRANSCRIPT
Webinar October 17, 2017
The Feds Are Coming! Session 1: The Rules Have Changed
Ryan Thurber Polsinelli PC
Jeffrey Fitzgerald Polsinelli PC
Elizabeth S. Grace, MD, FAAFP
Medical Director, CPEP [email protected]
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
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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
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
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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
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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
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
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/
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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
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
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
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
Changing Practice Standards: The Physician’s View
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A Changing Environment
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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
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Chronic Opioid Therapy
Harm
– Myocardial infarction
– Fractures
– Endocrine effects/markers of sexual dysfunction
– Sleep apnea
– Arrhythmias and sudden death (methadone)
– Abuse, dependence, OD
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
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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
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Chronic Opioid Therapy
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http://blog.aapainmanage.org/opioid-prescribing-dosage-threshold-ceiling/
Other Factors
Opioid misuse in youth
Epidemiology of ODs involving concurrent opioid and benzodiazepine use
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
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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.
“As every doctor knows,
nothing cuts short a patient visit
like a prescription pad.”
— Sam Quinones Dreamland
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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
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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
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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
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The only thing that is constant is change.
- Heraclitis (535-475 BC)
Putting Guidelines into Practice: Organizational Perspective
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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
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Webinar October 17, 2017
The Feds Are Coming! Session 1: The Rules Have Changed
Ryan Thurber Polsinelli PC
Jeffrey Fitzgerald Polsinelli PC
Elizabeth S. Grace, MD, FAAFP
Medical Director, CPEP [email protected]