Statement of Conflicts of Interest

Transcription

1 10 th Annual 340B Coalition Winter Conference Making a 340B Compliance Plan Work Lessons from a Community Clinic Brian Rasmussen Breitbard Pharmacy Director Cares Community Health February 5, 2014 Statement of Conflicts of Interest Brian Rasmussen Breitbard has no actual or potential conflict of interest in relation to this presentation Today s Goals Understand the importance of having a 340B compliance work plan in a community clinic and inhouse pharmacy. How to develop and implement a compliance program which covers areas of risk at your organization. 1

2 CE Questions Why should a covered 340B entity develop a compliance plan? What elements are included in an effective 340B compliance plan? Overview of Clinic: Cares Community Health Formerly known as CARES, is a community clinic in midtown Sacramento, CA transitioning from an HIV/AIDS clinic to FQHC LA Currently sees 2,700 active HIV/AIDS patients and 300 Community patients From a 340B perspective, transitioning from a Ryan White grantee participant to a FQHC LA Overview of Clinic: Services Offers a continuum of paid/reimbursable services: Medical Dental Behavioral health AOD Nutrition Chiropractic clinical pharmacy Pharmacy Also offers a walk in HIV/STD clinic (4500 patients per year) 2

3 Overview of Clinic: Payers Clinic payer mix Medicare/Medi cal Grants: Ryan White, CDC, and SAMHSA Commercial Insurance Self pay Pharmacy Payer mix Same as clinic plus ADAP Overview of the Pharmacy at CARES On site pharmacy 340B ship to address on the OPA web site Places orders for pharmacy and clinic Virtual dual inventory (WAC and 340B) 340B eligibility is determined in real time 500 scripts average a day (120,000 per year) No automatization besides counting machines Overview of a Compliance Program: The What and Why A system of internal controls designed to ensure that an organization regularly evaluates and monitors their adherence to applicable statutes, regulations, and program requirements. Demonstrates to regulators, employees and the community the organization s commitment to compliance. 3

4 Why Compliance Program for 340B Entity: To Avert Risk Increased scrutiny of program compliance and enforcement. GAO Report (2011) called for increased oversight Patient Protection and Affordable Care Act (PPACA) increased HRSA oversight and sanctions HRSA Audits Manufacturers Audits Senator s scrutiny of the 340B program Why Compliance Program for 340B Entity: Common Sense The 340B program affects more than one department in your clinic 340B can be complicated Helps increase staff awareness of the program Demonstrates commitment to compliance to community and staff Puts your 340B processes in writing and creates policies/procedures to share with your organization OIG Elements of an Effective Compliance Program Designation of a responsible individual Written policies and procedures Training and education Internal monitoring and auditing Process for responding to detected offenses Open lines of communication Disciplinary standards 4

5 Compliance and Cares Community Health Designate a responsible individual(s): Individual whose primary responsibility is implementation, administration and oversight of compliance program with full authority to carry out operational responsibility This position belongs to the Compliance Director and Pharmacy Director Compliance and Cares Community Health Written policies and procedures Consider the regulatory exposure of each 340B program function and emphasis on areas of special concern Key Policies/Procedures: 340B Eligibility (patient definition) Drug pricing (pharmacy and clinic) Drug inventory/dispensing (pharmacy and clinic) Billing standards (pharmacy and clinic) 340B compliance program Policy/Procedure Example: Pharmacy 340B Decision Tree 5

6 Monitoring and Auditing An ongoing evaluation process is critical to successful compliance. Look at areas of risk across functions: Purchasing Inventory reconciliation Billing compliance Eligibility (patient definition) Monitoring and Auditing Six pharmacy 340B audits are run weekly: Drug vendor audit Drug 340B indicator audit Patient status audit (EMR vs. pharmacy software) 340B modifier audit (for Medi cal and Medi cal Managed Care) Medi Cal adjudication (acquisition cost + dispensing fee) 340B audit report listing potential problems based on pre set parameters Communication/Response Pharmacy audit findings are discussed with pharmacy staff and across departments if needed 340B eligibility corrections are recorded in our compliance software Maintain open communication with the payers (e.g. 340B and Medi cal Managed Care Organizations) Work closely with IT to create audit reports and improve software when needed. 6

7 Training and Education Never underestimating the power of education and continual retraining to encourage compliance. Work with staff on a daily basis Provide 340B training during new staff orientation Work across departments to implement 340B policies as they relate to clinic drug administration and clinic billing Always remind the management team about the importance of 340B compliance CE Questions Why should a covered 340B entity develop a compliance plan? What elements should in an effective compliance plan? CE Question #1 Why must each covered 340B entity develop a compliance plan? A) The senator said I had to B) Demonstrate commitment to compliance C) Because procedures and policies should be put in writing and shared with your colleagues D) The 340B program can be complicated E) All of the Above. F) B, C and D 7

8 CE Question #1 Answer: F) B, C, and D CE Question #2 What elements are included in an effective 340B compliance plan? A) Internal Monitoring and auditing B) Written policies and procedures C) Training and education D) Designation of a responsible individual E) All of the Above F) A, B, and C. CE Question Example #2 Answer: E) All of the above. 8

9 Additional Questions? Brian Rasmussen Breitbard Pharmacy Director Cares Community Health st St. Sacramento, CA Phone: