1. Improved Retrospective Drug Utilization Review for Potential Opioid Overutilizers — Results from the Pilot CMS 2012 Medicare Advantage & Prescription Drug Plan Fall Enrollment, Marketing, and Compliance Conference Moderator: Cynthia G. Tudor, Ph.D., Director Medicare Drug Benefit and C&D Data Group September 5, 2012 Image of spilled med capsules CMS logo

2. Background Improved Retrospective DUR Programming and Case Management Morphine Equivalent Dose (MED) Analysis Pilot Panel Questions Session Overview 2

3. Epidemic: Responding to America’s Prescription Drug Abuse Crisis, April 2011 1 Opioid overdose is now the second leading cause of unintentional death in the United States, second only to motor vehicle crashes 2 People who abuse opioids have direct health care costs more than eight times those of nonabusers 3 GAO Report, Sept. 6, 2011,“Medicare Part D, Instances of Questionable Access to Prescription Drugs” 4 Background 1 http://www.whitehouse.gov/sites/default/files/ondcp/issues-content/prescription-drugs/rx_abuse_plan.pdf 2 Volkow ND, McLellan TA. Curtailing Diversion and Abuse of Opioid Analgesics Without Jeopardizing Pain Treatment. JAMA 2011;305(13):1346-1347. 3 Unintentional drug poisoning in the United States [July 2010]. National Center for Injury Prevention and Control. Centers for Disease Control and Prevention. http://www.cdc.gov/HomeandRecreationalSafety/pdf/poison-issue-brief.pdf. 4 GAO-11-699. (Washington, D.C.: Sept. 6, 2011). 3

4. For 2013, “Level Three” controls to apply to opioids (P&T Committee involvement) Part D sponsors should look for apparent duplicative opioid drug use over sustained periods of time and/or across multiple opioid drug products in high doses Focus on high dosage, sustained opioid use, and multiple providers Improved Retrospective DUR Programming & Case Management 4

5. Clinical staff should communicate with prescribers and beneficiaries to ascertain medical necessity Give prescribers information about the existence of multiple prescribers and the beneficiary’s total opioid utilization Results of case management to confirm: 1) current level; 2) lower level; or 3) no opioids. No status quo if prescribers non-responsive and MEDIC referrals as appropriate Provide 30-day advance written notice to beneficiary and opioid prescriber(s) of pending POS edits with the right to contest. No lock-in to specific prescribers or pharmacies Improved Retrospective DUR Programming & Case Management 5

6. MED is useful tool to assess and manage risks associated with use of opioids 5,6 CMS MED Analyses in Part D (2011 PDE) – Methodology Identify exclusion criteria (cancer, hospice) Develop MED conversion table for oral opioid analgesics Calculate cumulative, daily MED for each beneficiary Assess use of greater than 120 mg MED for at least 90 consecutive days Add criteria for multiple prescribers and pharmacies Morphine Equivalent Dose (MED) Analysis 5 Dunn KM, Saunders KW, Rutter CM, Banta-Green CJ, Merrill JO, Sullivan MD, Weisner CM, Silverberg MJ, Campbell CI, Psaty BM, Von Korff M. Opioid prescriptions for chronic pain and overdose: a cohort study. Ann Intern Med 2010;152(2):85-92. 6 Washington State Agency Medical Directors’ Group, Interagency Guideline on Opioid Dosing for Chronic Non-cancer Pain: An educational aid to improve care and safety with opioid therapy, 2010 Update. Available at www.agencymeddirectors.wa.gov. 6

7. CMS MED Analyses in Part D (2011 PDE) – Results, excluding cancer and hospice care 8.8 million (28%) opioid analgesic utilizers in Part D 1.8 million (5.6%) exceeded 120 mg MED for at least one day 225,000 (0.71%) exceeded 120 mg MED for at least 90 consecutive days 22,222 (0.07%) also used more than 3 prescribers and more than 3 pharmacies during the 90-day period Morphine Equivalent Dose (MED) Analysis 7

8. Participants: CVS/Caremark, Humana, UnitedHealthcare Discussion – Targeting criteria/beneficiaries selected – Due Diligence – Outreach to prescribers and beneficiaries – Outcomes and follow-up – Lessons learned Pilot Panel for “Level Three” 8

9. QUESTIONS? Any additional questions about the Part D overutilization policy should be directed to PartDPolicy@cms.hhs.gov using the Subject Line “Overutilization.”PartDPolicy@cms.hhs.gov 9