Toxicology for Pain Medication Monitoring. February 26 th Team Makena Sales Meeting

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1 Toxicology for Pain Medication Monitoring February 26 th Team Makena Sales Meeting

2 orthotox Leadership orthotox provides an unparalleled level of healthcare expertise to better serve our physician clients. Our executive team has more than 60 years of leadership in clinical, operational, sales and financial capacities. These synergistic skillsets enable us to truly understand the needs of the physician for optimal patient care and practice efficiency. Michael Sinel, M.D. is a board certified nationally recognized expert in physical medicine, back pain and rehabilitation medicine and a successful entrepreneur in medical and surgical ventures. Dr. Sinel practiced for 12 years as the Director of Physical Medicine and Rehabilitation for a prestigious Southern California Spine Institute. He served as Director of Physical Medicine at Cedars-Sinai Hospital in Los Angeles. He is an Assistant Clinical Professor in the Department of Medicine at UCLA, and the author of several scientific publications and two popular books on pain. Anthony Kjenstad has 20 years of experience in healthcare sales and consulting with an emphasis on ancillary programs, surgical devices and DME products. Anthony has worked with major orthopedic practices throughout the country to maximize clinical outcomes and profitability. Previously Anthony led a series of acquisitions and roll-up transactions to help create Team Makena, a marketleading provider of hundreds of high quality technologically advanced products available to surgeons and patients with best-in-class service and support. Michael Roub has served in executive capacities in operations, business development and finance roles. He has co-founded multiple successful healthcare sales and management organizations. Michael previously served as head of acquisitions for a national healthcare provider and also developed multiple surgery centers with 100+ physician partners. He is a former investment banker who received an M.B.A. from the University of Chicago Booth School of Business and a B.S. from the Wharton School of Business.

3 Overview Urine drug screen (UDS) for the monitoring of patients pain medication use has become an increasingly effective and accepted treatment tool orthotox has partnered with premier laboratories and service providers to offer physicians a comprehensive UDS program The CDC recommends UDS for patients using prescription painkillers Several states have developed medical treatment guidelines that include pain medication monitoring via UDS Turnkey program minimal paperwork and rapid implementation We have developed protocols and systems to provide a paperless, efficient platform with superior customer support for its clients. For practices with significant toxicology testing volume potential, orthotox can assess and implement an in office analyzer program

4 Why Perform Compliance Drug Testing Center for Disease Control and Prevention 1/13/2012 / 61(01);10 13: Prescription Drug Overdoses a U.S. Epidemic Prescription drug abuse is the fastest growing drug problem in the United States. Joseph E. Couto, PharmD., M.B.A.: Data from 938,586 patient test samples showed that 75% of patients were unlikely to be taking their medications in a manner consistent with their prescribed pain regimen. Opioid Guidelines in the Management of Chronic Non Cancer Pain. Pain Physician Vol. 9, Chapter 7.3: "Urine drug testing can improve a physician's professional ability to manage therapeutic prescription drugs with controlled substances, and to diagnose substance abuse or appropriate intake of drugs, thereby leading to proper treatment.

5 Information on AAOS Website Pain medications and patient safety After the AAOS Patient Safety Summit in 2012, a group of hand and foot surgeons looked at major safety issues regarding outpatient surgery. According to David C. Ring, MD, chief of the Harvard Hand Service, opioid misuse was one of the major safety risks identified. Because the number one cause of death in young adults is opioid overdose, the group believes that the way physicians think about and manage postoperative pain needs to undergo a paradigm shift. Physicians should also consider adopting pain management protocols to mitigate risk and reach out to pain management and hospice services when those protocols do not adequately control pain. Deaths from prescription opioid overdoses in the United States exceed the deaths from heroin and cocaine combined. Opioids and orthopaedics Opioid medications are commonly prescribed in orthopaedics for a short term after surgery for acute pain control. Studies have examined the risk of chronic opioid use after ambulatory surgeries. In a 2012 retrospective, population-based study, researchers found that patients who had not previously used opioids and received a prescription for opioids within a week after a short-stay surgery were 44 percent more likely to still be using opioids at 1 year from surgery than those who did not receive such prescriptions.

6 Example taken from AZ Opiate Guidelines Summary of Arizona Opioid Prescribing Guidelines for the Treatment of Chronic Non- Terminal Pain (CNTP) (7) For patients on chronic opioid therapy (COT), monitoring progress and adherence to the treatment plan is essential to optimize patient care and the overall benefit to risk profile. Appropriate monitoring for COT includes, at a minimum: (1) regular assessment with face to face encounters (2) assessment of response to therapy including assessment of the 6 A s (analgesia, activity, aberrant drug related behaviors, adverse effects, affect, and adjuncts), (3) periodic query of the AZ Controlled Substances Prescription Monitoring Program, and (4) periodic completion of UDT. Frequency of monitoring should be determined by risk category.

7 Rampant Painkiller Prescribing in U.S. The quantity of prescription painkillers sold to pharmacies, hospitals and doctors offices was 4 times larger in 2010 than in 1999

8 Epidemic Drug Overdose Rates Nearly 15,000 annual deaths from prescription painkiller overdoses In 2010, 1 in 20 people in the U.S. (age 12+) reported using prescription painkillers for non medical reasons in the past year

9 Benefits of Compliance Drug Testing Benefits to Physician Practice Establish efficient treatment plans with monitoring ability More accurate assessment of patient s condition Compliance with suggested pain medication guidelines Rapid report turnaround (48 hours) with EMR integration Revenue for point of service testing For workers comp patients in several states an optional medical record review can be produced and billed by practice Benefits to Employee Decreased abuse of prescribed medications Detection of medication diversion Improved overall pain management More effective treatment compliance Benefits to Employer Significant cost savings due to conservative confirmatory testing and billing practices Improved pain management through early detection of abuse or diversion may result in: Earlier return to work Faster closure of claim Reduction of medical costs

10 Program Benefits Extensive expertise with orthopedic practices, including clinical advisors to review protocols with physicians Easy to read lab reports Conservative laboratory partners Unique software solution Paperless system (practices can opt to use/receive hard copies) View toxicology reports online Integrate with EMR system High level of customer service Assistance with set up, billing and ongoing support Customized panels available to meet physician needs Work Comp: optional medical record review consideration(not in CA.) Analyzer: large volume practices may have the opportunity to bring testing capabilities in house and generate additional income Possible Fractional Ownership of Lab if Qualfied(More to come)

11 Toxicology Management Testing Protocol Workers Comp New Patient baseline test Test every 3 months thereafter Established Patient pre/post surgical visit Prescribing narcotics Concern of drug use Every 3 months thereafter Private Insurance/Medicare New Patient Prescribing narcotics Concern of drug use Established Patient pre/post surgical visit Prescribing narcotics Concern of drug use Test New and Existing Patients Based Upon Protocols (to establish baseline for pharmaceutical management) Review Results Consult Review Physician consult/review medication regimen with patient Retest NEGATIVE results: Retest at next visit or as medically necessary POSITIVE results: Retest at 90 days or as medically necessary Check to make sure patient is consistent with prescribed medications

12 Sample Laboratory Report Easily interpreted report uploaded to secure website Medication inconsistencies highlighted in lab report Files can be manually added to EMR or automatic upload is available

13 MD Patients Software Web based application Requires no hardware or software infrastructure at client site Allows for paperless management of program HIPAA and Hi Tech compliant Ability to integrate into different EMR/EHR programs This always comes at a cost that can sometimes be significant. Functionality includes: Patient maintenance Label creation Shipping Manifest Entry of Rapid Test Results Review of Lab Results including optional review of record report

14 Online Laboratory Report Lab reports easily located with downloadable files available with one click Inconsistent results flagged for review Test status and/or delivery issues are also flagged for practice

15 Review of Record Report 4 page Review of Record report available online by clicking ROR Creates a billable event for workers comp patients Files can be manually added to EMR or automatic upload is available

16 EMR Considerations MD Patients software can be integrated with most EMR platforms After contracts signed, our team will coordinate with EMR provider and MD Patients integration team for an initial assessment Time to implement and potential cost considerations will be evaluated Alternative for EMR use Practice can provide software/billing provider with EMR access Reports can then be manually transferred into the practice s EMR system without the use of practice staff This can be an interim solution to full EMR integration or an on going process depending upon practice needs Paper based (hard copy) If there are any system issues, a practice can always use paper requisition forms and receive their reporting via fax or mail

17 Toxicology Staffing Most practices utilize an existing employee to manage their toxicology program Some practices with staffing constraints and/or large toxicology needs may require additional support orthotox s lab/billing partner can potentially place an employee on site to manage paperwork and processing needs Costs of employee are that of lab/billing partner, not the practice Practice can recommend an employee for high or one will be recruited by lab/billing partner Employee cannot handle specimens directly

18 Conservative Approach In addition to standard panels, orthotox lab partners offer customizable panels to test panels only as specified by the physician

19 Client Set Up and Support Protocols orthotox works closely with its sales reps to ensure that client setup is simple, thorough and effective orthotox will ensure that set up and initial support for a practice maximizes testing potential

20 Analyzer Opportunity orthotox and its partners will analyze the potential to place an analyzer within a physician practice Revenue of approximately $100/test to physician practice Sufficient complex testing volume needed to implement Analyzer can be purchased, leased or used on a cost per test basis orthotox will coordinate all certifications, equipment and installation Staffing required for running lab will be provided for the practice, including all necessary clinical supervisors Practice will be running tests within 60 days Confirmatory tests will be sent to an orthotox lab partner

21 Toxicology Sample Pro Forma Sample Assumptions Payor Mix: 50% PPO, 10% WC, 40% Medicare 50% of claims paid by carriers Rapid Cup Revenue: G0434 $31/test G0434 Medicare $22/test Review of Record Revenue: $200 on paid W/C claims ESTIMATED PROFIT Monthly Tests PPO Rapid Cup (G0434) Tests PPO Est. Revenue 775 1,550 2,325 3,100 3,875 Avg. Revenue per Test $ 16 $ 16 $ 16 $ 16 $ 16 Medicare Rapid Cup (G0434) Tests Medicare Rapid Cup (80101) Tests Medicare Est. Revenue 880 1,760 2,640 3,520 4,400 Avg. Revenue per Test $ 22 $ 22 $ 22 $ 22 $ 22 Work Comp Rapid Cup (G0434) Tests Work Comp Est. Revenue 1,155 2,310 3,465 4,620 5,775 Avg. Revenue per Test $ 116 $ 116 $ 116 $ 116 $ 116 Gross Revenue $ 2,810 $ 5,620 $ 8,430 $ 11,240 $ 14,050 Cup Expense $5/Test $ 500 $ 1,000 $ 1,500 $ 2,000 $ 2,500 Monthly Net Profit $ 2,310 $ 4,620 $ 6,930 $ 9,240 $ 11,550 Annual Net Profit $ 27,720 $ 55,440 $ 83,160 $ 110,880 $ 138,600

22 Things to consider/what I have learned. Ask your physician where they are sending their pain patients. This opens door for new opportunity and new customer. Not only are they doing Tox already but they probably are not using bracing as much as they could be. Not limited to Ortho. Primary care #1 prescriber of meds. Pain Management, Internal Medicine Guys(Preops) Lots of Revenue in Tox but don t forget your core business. Educating Ortho s on use of Tox can be challenging. Make sure your customer is not just looking at economics of transaction and cares what the results of the test are and is willing to manage them. Protect your customer from themselves. Reimbursement and coverage change drastically in this new healthcare environment so be flexible in your understanding and presentation. We see reimbursement from lab test all over the map from $0 $1800. You are on the front edge of this opportunity. If you missed the DVT train 4 years ago don t miss this train. Ask people who were early adoptors. Although the lab hires the collectors we essentially manage them in the field.

23 Thank You To help you get started or to address any questions, please contact orthotox at any time. Michael Sinel, M.D. Founder, Clinical Advisor ǀ Anthony Kjenstad National Sales Manager ǀ

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