Best Practices for 340B Internal Audits and Key Takeaways from the Winter 340B Coalition Conference

Transcription

1 Best Practices for 340B Internal Audits and Key Takeaways from the Winter 340B Coalition Conference February 9,

2 Webinar Panelists! The Panel! Tammy Zukowski, MBA! Douglas E. Miller, Pharm.D.! William W. Wood, RPh! Gavin Magaha, Pharm.D., MS! JeanAnn Lennard, PharmD, MBA 2

3 What s New & What s Not Omnibus Guidance ( Mega-Guidance ) ACA Repeal AMP Rule HRSA Audits Bizzell Group Voices from the Crowd Contract Pharmacies Provider-Based Clinics 3

4 Omnibus Guidance (The Mega-Regs ) OMB has withdrawn the Mega-Guidance All new & pending regs have been put on HOLD HRSA / OPA will have to resubmit it to have it reconsidered Could be revised or abandon Unlikely to be published in 2017 Some speculate that they will never be published as official guidance Remember the Patient Definition Rule of

5 ACA and the AMP Rule ACA Uncertainty sums it up ACA Repeal & Replace is more like Repeal & Repair Unsure How, When, & Where Timing??? Full Repeal is Unlikely Not enough votes Budget Reconciliation??? AMP was set to be implemented in April Rules not implemented have been put on HOLD 5

6 HRSA Audits Bizzell Group Subcontracted by HRSA to conduct Audits Expect ~300 Audits in FY 2017 conducted by the Bizzell Group Bizzell Group Mostly Pharmacists (former Directors of Pharmacy) Many had experience in the Peer-to-Peer Group Shortened Timeframe for Audit Notice to On-Site Audit 2 weeks from Notice to Submit Data 2 weeks from Data Submission to On-Site 6

7 Voices from the Crowd Covered Entities Self-Inflicted Wounds - Retail pharmacies moving out from under CE s tax ID; creating LLCs - Good in some cases (GPO availability) - Detrimental in others (Limited Distribution Drugs) Provider-based Clinic Expansion - Bipartisan Budget Act 2015 decreased reimbursements to hospitals for new PBCs and those that move after Nov 2, Systems misinterpreting they can still be created Revenue-sharing Under Microscope - Systems starting to look at where their savings are going - Some losing 25% to 3 rd parties (split-billers, contract Rx s, consultants) 7

8 Audit Readiness Review Experience Visante s Findings 8

9 Contract Pharmacies Contract pharmacies remain an audit target Covered entity is responsible for all actions of contract pharmacies Number of contract pharmacies is factor for HRSA audit selection 75% of HRSA audits that required repayment to manufacturers were associated with contract pharmacy-related findings 9

10 HRSA Audits of Covered Entities HRSA audits started in 2012 ~75% of audits have been of hospitals Findings: Facility eligibility, diversion, duplicate discounts, OPA database record, failure to provide oversight of contract pharmacies, auditable records Repayment obligations: Facility Eligibility CE + Child Sites Diversion Duplicate discounts 10

11 HRSA Audits of Covered Entities Other covered entity corrective actions included: Policies and procedures Lack of annual external independent audit of contract pharmacies Inventory management systems Increase the frequency of internal audits Lack of compliance training Incorrect OPA Database entries Medicaid Exclusion File Work with state Medicaid agencies Improve internal controls in mixed-use areas Failure to maintain auditable records 11

12 Visante Audit Experiences Visante has conducted more than 130 Comprehensive 340B Integrity Assessments and Audit Readiness Reviews for a wide variety of covered entities types DSH, PED, RRC, SCH, CAH, HV, RWII, RWIII, HTC Audited hundreds of thousands of contract pharmacy transactions Worked with all the major split-billing vendors Have provided on-site support of clients during HRSA Audits Have provided assistance developing CAPs for clients 12

13 Visante Audit Experiences HRSA auditors are asking about floor stock and routinely focusing more heavily on inventory methods and responsibilities: Eye drops being sent to Ophthalmology Clinic Lidocaine 30ml vials, Saline and Heparin Flush Syringes Providers: Only SOMETIMES eligible vs. ALWAYS eligible Rule of 75 Percent ~75% of all audits resulted in some type of finding ~75% of audits with findings resulted in repayment to manufacturers ~75% of audits that required repayments were associated with contract pharmacy problems or findings 13

14 Best Practices Visante s Recommendations 14

15 Internal Audits Minimum of Quarterly Audits In-house pharmacies Contract pharmacies Mixed-use areas Procedure Listing of all prescriptions dispensed and/or medications administered EHR chart review Medication usage reports & purchases Annual independent audits 15

16 Internal Audits Conduct sampling audit Trace claim from pharmacy claim back to the patient medical record Validate claim Eligible patient Eligible provider Written at an eligible location Use statistical sample claims per location for quarterly internal audits 10 claims per location for monthly internal audits Use a mixture of random & targeted claims 16

17 Medicaid Regularly Review OPA Database Including Medicaid Exclusion File Billing Procedures Communicate with State Medicaid Directly Document Communication and Updates Name, Title, Phone #s, etc. Written Procedures to Identify Responsible Personnel 17

18 Medicaid Managed Care Medicaid Fee-For-Service (FFF) Medicaid Exclusion File (MEF) Out-of-State Medicaid Medicaid Managed Care No standard method of identifying MCO claims Each state determines what method to use MEF, UD Modifier, Forced Carve-Out of MCO claims, etc. Suggested separate MEF for FFS and MCO Medicaid claims CMS requires states to design and implement methods to identify. Appears to place compliance burden on states but CEs remain responsible for duplicate discount avoidance. Even if the state does NOT use MEF, OPA requires being listed 18

19 Key Policies and Procedures Purchasing Inventory Invoice processing Contract pharmacy oversight Medicaid billing Patient eligibility qualifications Self-disclosure / Material Breach Organizational responsibilities of key personnel 19

20 OPA Database Quarterly Check all names, addresses, and phone numbers for accuracy Check contract pharmacies for accuracy of all information Verify accuracy of shipping addresses and Child Site information Annually Check Child Site eligibility against Cost Report Review contract pharmacy agreement(s) 20

21 Compliance Oversight 340B Steering Committee or Compliance Committee 340B Authorizing Official 340B Primary Contact Senior Pharmacy Leader Compliance Officer General Counsel or outside attorney CFO Finance / Reimbursement 21

22 Potential Areas of Synergy Comprehensive 340B Assessment & Integrity Audit Readiness Review Annual Independent External Audit Other Visante Services New and expanded retail pharmacy services Ambulatory clinical pharmacy opportunities Specialty pharmacy Employee Rx benefit Discharge prescription capture 22

23 Questions? 23