1. Collaborative Practice Agreements: How to Get Started and How to Get Paid Donald G. Klepser, Ph.D, MBA Associate Professor University of Nebraska Medical Center Department of Pharmacy Practice

2. Pharmacists

3. Community Pharmacies ~60,000 in the United States Most patients visit their pharmacy more often than any other health care provider Underutilized health care resource Regular but incomplete communication with prescribers and other providers

4. Overarching Question How do we develop a patient-centered system that utilizes the resources and expertise of all members of the health care team to acheive the best possible outcomes (Clinical, Humanistic, and Economic) for patients? The caveats: – Without blowing up the system and starting over – Without fragmenting care – Without sacrificing profit (must be sustainable) – Without disrupting workflow

5. Collaborative Practice Agreements (CPAs) Formal practice relationship between pharmacists and other health care practitioners, whereby the pharmacist assumes responsibility for specific patient care functions that are otherwise beyond their typical “scope of practice” but aligned with their education and training. These patient care services can include initiation and modification of drug therapy.

6. Collaborative Practice Agreements (CPAs) The extent of the services authorized under a collaborative agreement depends on: 1.The state’s statutory and regulatory provisions for collaborative practice authority. 2.The terms of the specific agreement between the pharmacist and other health care practitioners.

7. 50 States, 50 Sets of Rules States have taken different approaches to Collaborative Practice Agreements including: 1.The practitioners able to participate in CPAs, 2.The services that may be provided under a CPA, 3.Logistical barriers that limit the utility of such agreements. States do not consistently use the same language when describing CPAs. – Protocols – Collaborative Drug Therapy Management

8. National Governors Associtiaon (NGA) In their 2015 paper, The Expanding Role of Pharmacists in a Transformed Health Care System, the NGA, presented the following state policy considerations in regards to collaborative practice provisions:  Enact broad collaborative practice provisions that allow for specific provider functions to be determined at the provider level rather than set in state statute or through regulation.  Evaluate practice setting and drug therapy restrictions to determine whether pharmacists and providers face disincentives that unnecessarily discourage collaborative arrangements.  Examine whether CPAs unnecessarily dictate disease or patient specificity National Governors Association. The Expanding Role of Pharmacists in a Transformed Health Care System. http://www.nga.org/files/live/sites/NGA/files/pdf/2015/1501TheExpandingRoleOfPharmacists.pdf Accessed 6/20/16

9. National Alliance of State Pharmacy Associations (NASPA) NASPA convened a work group to build on the NGA report to guide policy making. Used two guiding principles to determine what needed to be included in Laws and Regulations and what should be decided by individual practitioners: 1.Framework should be flexible to facilitate innovation in care delivery 2.Safeguards should be established to ensure optimal patient care

10. National Alliance of State Pharmacy Associations (NASPA) Made recommendations on Participants Authorized services Requirements and Restrictions http://naspa.us/wp-content/uploads/2015/08/CPA-Infographic-PDF.pdf

13. Recommended Elements of a CPA Participants List which pharmacists and prescribers are included Identify any additional education or training necessary for the pharmacist Identify the patient population

14. Recommended Elements of a CPA Authorized Services Specify which disease states are being managed Specify the services included Specify which protocols or clinical guidelines are to be followed

15. Recommended Elements of a CPA Requirements and Restrictions Specify appropriate level of patient consent Specify timeframe for renewal Specify the documentation process Specify liability insurance requirements

16. Our Experience with CPAs Point of Care Testing in Community Pharmacies

18. A role for POC testing in community pharmacies >120 CLIA Waived tests Complete disease management in the pharmacy – Influenza and group A streptococcus (GAS) Disease screening (HIV and HCV) Disease and treatment monitoring Precision medicine Reduced antimicrobial resistance Public health emergencies (lead testing)

19. Patient Assessment Point of Care Test Action Enabled by Broad CPA Improved Health Outcomes Model for Acute Conditions…

20. Patient Assessment Point of Care Test Action Enabled by Broad CPA Improved Health Outcomes Model for Acute Conditions… The value is the comprehensive pharmacy service enabled by a Collaborative Practice Agreement.

21. Experience from Regional Chains Prospective study of Influenza and Group A Strep (GAS) testing and treatment 56 pharmacies from 5 regional chains in three states (MI, MN, NE) Trained all pharmacists (20 hour certificate program) Developed Algorithms from clinical guidelines (inclusion and exclusion criteria, clinical thresholds) Template state specific collaborative practice agreements Workflow (data collection instruments and scripts)

22. Included in the CPA Patients eligible to be tested at the pharmacy – Age – Symptoms – Clinical stability – Comorbidities Patients with a positive test were offered prescription Patients with negative test were counseled and provided OTC options All patients tested had a follow up call from the pharmacist 24- 48 hours after their visit Visit results were shared with the patient, their primary care provider, if possible, and the collaborating physician

23. Clinical Studies – Influenza Results 121 patients screened 46 (38%) excluded from participation 75 (62%) tested, with 8 (11%) positive results Of positive results, 6 (75%) treated with antiviral, 0 with antibiotics 59 (79%) of patients were reached for follow-up with 24-48 hours 6 patients sought additional care (4 were referred by pharmacist) 35% of patients had no primary care provider 39% of patients were seen outside of normal clinic hours Klepser, et al. Journal of the American Pharmacist Association.

24. Group A Strep Results 316 patients screened 43 (14%) excluded from participation 273 (86%) tested, with 48 (18%) positive results Of positive results, 47 (98%) treated Of negative results, 0 (0%) treated 169 (62%) of patients were reached for follow-up with 24-48 hours 37% of patients had no primary care provider 34% of patients were seen outside of normal clinic hours Klepser, et al. Journal of the American Pharmacist Association.

25. Workflow Considerations Initial patient assessment Pharmacist collects illness history, runs test, and obtains vitals Positive test – Rx processed Negative test – OTC assistance Follow-up protocol Inform PCP

26. Workflow – Time and Motion Studies Overall encounter time of 35.5 minutes Active pharmacist engagement 9.4 minutes When technicians played a larger role in data collection and physical assessment, active pharmacist engagement fell to 4.95 minutes Klepser DG, et al. Innovations in Pharmacy. 2014;5:1- 8.

27. Patient Satisfaction Strongly Agree/Agr ee Satisfied with how illness was treated at the pharmacy 86% Would go back to the pharmacy for a similar illness in the future 82% Are comfortable being treated by my pharmacist for illnesses like the flu 96% Klepser DG, et al. National Rural Health Association. 2014

28. Willingness to Pay Patients were asked how much they would be willing to pay for pharmacy based influenza or GAS service. 60% of patients were willing to pay at least $50 for these service.

29. Ongoing Research Follow up studies –Expanded to 11 states –Cultures for GAS negative pediatrics –Additional funding from NACDSF and Roche Diagnostics HIV and HCV screening and linkage to confirmatory testing –3 states (Michigan, Georgia, West Virginia) –CDC and state public health collaboration –Mandatory –Funded by NACDSF

30. Getting Paid for Care Provided for under a CPA Provide a service people value Provider status Out of network claim forms Contract directly with employers Future payment models

32. Questions? Don Klepser dklepser@unmc.edu