Opioid Epidemic & Overview of cPNB Solution 5/2/2019 Some products described in these materials are under development at Smiths Medical and are not available for sale. There is no guarantee of the eventual availability, safety, or effectiveness of these products. The products described are subject to FDA 510(k) Premarket Notification clearance and receipt of CE Mark prior to commercial distribution. Executive Summary • An estimated 4.3 million people are currently abusing prescription pain relievers (opioids). • Drug overdose and opioid-involved deaths continue to increase. According to the CDC, 91 Americans die every day from an opioid overdose, which includes prescription opioids and heroin. • The Continuous Peripheral Nerve Block (cPNB) solution: • Ambulatory infusion smart pumps safely deliver pain medication through peripheral nerve block to patients in hospital, home care and alternative care facilities, reducing the use and therefore risk of opioid dependency. • Twelve studies included (2006). Total opioid consumption over 48 h was significantly less (P < 0.001) with the use of cPNB. Patients on a cPNB required about 60% less opioids than patients who received only opioids for their post-op pain. • The National Institute on Drug Abuse (NIH) reported that roughly 21 to 29 percent of patients prescribed opioids for chronic pain misuse them and between 8 and 12 percent develop an opioid use disorder. • • The costs associated with untreated opioid use disorders include costs related to criminal justice, treating babies born dependent on opioids, greater transmission of infectious diseases, treating overdoes, injuries associated with intoxication and lost productivity. The Center for Disease Control and Prevention suggested that total costs of prescription opioid use disorders and overdoses was $78 billion in 2013 with only 3.6 percent (about $2.8 billion) for actual treatment. 2 Proprietary and confidential Why cPNB at home • Better post-operative pain control and reduced opioid consumption • Bundled procedural costs influence facilities to send patients home quickly, but should not influence access to the most effective care. • Patient usually leaves hospital/same day surgery center within hours of procedure, currently disincentivizing the use of non-opioid pain alternatives. • cPNB is typically used 3 to 5 days post procedure. • Use of short acting anesthetics like bupivacaine or ropivacaine through cPNB provide cost effective pain relief and minimize exposure to opioids. • Patients can move directly to over the counter anti-inflammatory drugs, for example Ibuprofen or Advil when a catheter is removed thus minimizing exposure to opioids. • Patient goes home with durable medical equipment ambulatory pump, catheter, supplies and virtual nursing support 24/7. • Pump provides alarms, delivery accuracy. 3 Proprietary and confidential Opioid Commission, Congress, Stakeholders The President’s Opioid Commission- Recommendation 19 “The Commission recommends CMS review and modify rate-setting policies that discourage the use of non-opioid treatments for pain, such as certain bundled payments that make alternative treatment options cost prohibitive for hospitals and doctors, particularly those options for treating immediate post-surgical pain.” Support for Patients and Communities Act-HR 6 SEC. 6082. With respect to payments made under this subsection for covered OPD services (or groups of services), including covered OPD services assigned to a comprehensive ambulatory payment classification, the Secretary— ‘‘(i) shall, as soon as practicable, conduct a review (part of which may include a request for information) of payments for opioids and evidence-based non-opioid alternatives for pain management (including drugs and devices, nerve blocks, surgical injections, and neuromodulation) with a goal of ensuring that there are not financial incentives to use opioids instead of non-opioid alternatives Congressional Letters • • April 9, 2019 -39 members of the House of Representatives sent a letter to Secretary Azar. April 18, 2019- 13 members of the Senate and 3 members of the House sent a letter to Secretary Azar. 4 Proprietary and confidential Opioid Commission, Congress, Stakeholders Third Parties Support Pain Management Alternatives 5 Proprietary and confidential 2019 Ambulatory Surgery Center Rule • The 2019 ASC rule provided coverage for Exparel, a single shot nerve block for pain patients, but there is more that can and should be done in this space. CMS should be considering multiple opioid alternative options, rather than a single solution for one company. • cPNB is indicated for more uses than Exparel, and in this time of the opioid epidemic it is imperative doctors and patients have access to all pain care options following orthopedic procedures. • As per the Christie report and Congress, CMS should incentivize the use of non-opioid pain treatments. cPNB is a well-studied and practiced solution that should receive payment outside of the bundle in both the ASC and OPPS settings 6 Proprietary and confidential Reimbursement is Needed to Reduce Opioid Use • CMS is currently lagging behind payment for cPNB use of an ambulatory infusion pump for acute post-operative pain management. • During a 12-month period between 2017-2018, 82% of the claim payers billed by InfuSystem deemed the electronic pump for post-operative pain management as medically necessary and payable, in addition to the payment for the underline procedure. • Payers utilizing cPNB in the home include, Aetna, Blue Cross, Cigna, Coventry, HealthNet, Humana, Kaiser, TriCare, United Healthcare and many others. • 100% of the Medicare Advantage plans billed by InfuSystem deemed the service to be medically necessary and payable. 7 Proprietary and confidential