340B Compliance at a Critical Access Hospital. Conflict of Interest. Goals. Making a 340B Compliance Plan Work Part 2 Hospitals
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1 10 th Annual 340B Coalition Winter Conference 340B Compliance at a Critical Access Hospital Making a 340B Compliance Plan Work Part 2 Hospitals Reid Horning, PharmD Pharmacy Manager New Ulm Medical Center New Ulm, MN February 5, 2014 Conflict of Interest Reid Horning has no actual or potential conflict of interest in relation to this presentation. Goals Describe simple techniques for accomplishing compliance monitoring Transaction Review Purchase History Review Assess drug storage areas Discuss 340B Readiness Committee Describe 340B Stewardship 1
2 CE Question Considerations for 340B effective compliance monitoring should include which of the following? a. A program written within policy b. Developing a competency statement for purchasing c. Review of accumulator transactions d. All of the above Background NUMC is an integrated hospital and clinic; part of Allina Health Services include (2013 statistics) 24 hour ED (11,332 visits) General and orthopedic surgery (411/472 surgeries) OB/GYN (315 births) Inpatient/outpatient psychiatry (530 admissions/8,387 hours) Clinic (87,130 contacts) Oncology (4,947 Outpatient visits) Background Pharmacy department 3.5 FTE pharmacists 3.5 FTE technicians Pharmacy operations Day shift Inpatient services Anticoagulation, kinetics, drug interaction evaluation Ambulatory services MTM, drug information 2
3 Background Pharmacy Operations Electronic medical record with CPOE 109,000 medication orders verified in 2011 Approximately 15% were oncology orders 340B program fully implemented April 1, 2011 Drug Cost Statistics $4.3 mil drug budget $500 k inventory Total drug cost per adjusted admission: $588 Compliance Management Overview 340B Operations A Hybrid Model Clinic Physically Separate Inventory Hospital Virtual Inventory Accumulator software 3
4 Clinic Management Inspect the drug storage areas Look for unapproved storage locations Look for non formulary drugs Co mingling Samples? Clinic Management Avoid Diversion Transferring or Lending medications Clinic Management Avoid Diversion Outreach providers Medications excluded Inventory is physically separate and purchased using non 340B account 4
5 Clinic Management Understand requisition process Who places order? Buyer needs to understand 340B policy and procedures Clinic Management Items in orange excluded (better contract pricing) Clinic Order Requisition Items in orange excluded (better contract pricing) 5
6 Hospital Management Check accumulator transactions Follow several transactions through order all the way to administration Checking that patient was eligible (outpatient) Checking that medication is included (orphan?) Verify correct accumulations based on pack size Verify transactions are uploading accurately Hospital Management Check purchase history Given the number of 340B transactions for a given drug over period of time, does the purchase history align? Consider targeting high cost medications or unusual transactions Hospital Management Check that purchase orders are accurately filled Have a way to resolve invoice anomalies Credit/Rebill process 6
7 Hospital Management Avoid Diversion Transferring or lending medications 340B Compliance Program Develop policies and procedures that describe the utilization of the program at your site Develop a monitoring process for validating your program Look for non qualifying purchases within reports from the accumulator service 340B Compliance Program Establish a 340B readiness committee Both System wide and at Site Have meetings and take minutes Share learnings Involve administration Similar to Joint Commission readiness 7
8 340B Stewardship Pharmacy Resident MTM services at no charge Discharge telephone call follow ups Medication Reconciliation Consults in Clinic CE Question Considerations for 340B effective compliance monitoring should include which of the following? a. A program written within policy b. Developing a competency statement for purchasing c. Review of accumulator transactions d. All of the above Answer to CE question d. All of the above 8
9 Contact Information Reid Horning, PharmD Pharmacy Manager New Ulm Medical Center New Ulm, MN 9
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