Key Takeaways from the Winter 340B Coalition Conference

Transcription

1 Key Takeaways from the Winter 340B Coalition Conference Kristin Fox-Smith, MPA Douglas E. Miller, PharmD Tony Zappa, PharmD, MBA February 25,

2 Visante Structure Founded in 1999 to provide pharmacy-related growth and management strategies for hospitals, health systems, managed care organizations and pharma/tech companies Visante, pronounced VEE-sahnt, combines the French words for Life (vie) and Health (sante) Visante Limited created in 2011 for international work Offices: St. Paul, MN; London, UK; Toronto, Canada Currently have 63 US based consultants and 8 international based consultants 2

3 What s New & What s Not Omnibus Guidance ( Mega-Guidance ) Medicaid MCO Billing AMP Rule HRSA Audits Contract Pharmacies Visante s Audit Experiences Annual External Independent Audits Assistance On-Site with HRSA Audits Visante s Compliance Tool: 340B 3

4 Omnibus Guidance (The Mega-Regs ) No New News HRSA / OPA is still reviewing and evaluating all the comments submitted Over 1,250 comments were submitted 785 comments submitted by DSH Hospitals Virtually all different types of covered entities submitted comments Pharma and others also submitted comments Unlikely to be published in 2016 Some speculate that they will never be published as official guidance Remember the Patient Definition Rule of

5 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 5

6 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 6

7 New AMP Rule Proposed rule published Feb to implement Medicaid provisions in Affordable Care Act (ACA) and address other issues, referred to as the AMP Rule Final rule issued Jan. 21, 2016, published in Federal Register Feb. 1, 2016 (81 Fed. Reg. 5170) ACA provisions include: Determination of Average Manufacturer Price (AMP) Expansion of rebates to Medicaid Managed Care Other provisions include: State reimbursement of fee-for-service (FFS) drugs; exclusions from best price ; manufacturer reporting requirements Appears to apply to retail settings, not physician administered drugs 7

8 AMP Rule: Key Implications for 340B No direct changes to 340B compliance requirements for covered entities Potential immediate, indirect impact: AMP could have an indirect impact on 340B prices Best price exclusions could make it easier for 340B entities to access voluntary discounts from manufacturers Future Guidance to State Medicaid Agencies No immediate impact on reimbursement, but states may make changes over the next year to base payments to 340B covered entities on actual acquisition cost (AAC) (those that do not already do so) States are instructed to issue guidance on how entities can identify 340B eligible Managed Medicaid claims Are commercial payors likely to follow suit with AAC-based reimbursement? 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 % of audits have been of hospitals Findings: Eligibility, diversion, duplicate discounts, OPA database record, failure to provide oversight of contract pharmacies Repayment obligations: Diversion Eligibility Duplicate discounts 10

11 HRSA Audits of Covered Entities Other covered entity corrective actions included: Policies and procedures Inventory management systems Increase the frequency of internal audits Lack of compliance training Correcting 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 80 Comprehensive 340B Integrity Assessments and Audit Readiness Reviews for a wide variety of covered entities types DSH, PED, CAN, RRC, SCH, CAH, HV, RWII, RWIII, HTC Audited hundreds of thousands of contract pharmacy transactions Worked with all the major split-billing vendors 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 Internal Audits 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 14

15 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 Usually between claims over 6 month period Use a random sample generator 15

16 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 16

17 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) 17

18 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 18

19 Visante s Compliance Tool: 340B A New Way to Manage Self-Audits 19

20 Compliance: Increasing Challenge Covered entities consistently struggle with managing and performing selfaudits, often leading to less-than-perfect HRSA/OPA audits, sanctions and public notices of findings Lack of clarity regarding requirements Limited staff resources Proposed Mega-Guidance increasing audit requirements Quarterly self-assessments and reviews Annual independent audits Annual attestation of compliance during recertification Manufacturers demanding more oversight 340B administrators not supporting compliance as expected 20

21 Self-Audits Current State Audits performed as staff have 2me or only when problems found Disorganized document reten2on and filing P&Ps that are not updated with program changes Limited visibility by senior management to program performance High risk of poor audit outcomes, including acestor s personal liability Desired State Directed audit tasks based on monthly, quarterly and annual schedule Central repository for all 340B- related documents, including transac2onal audits Supported by industry experts with updates as program rules change High- level dashboard showing audit performance and program risk levels Minimal risk of poor audit outcomes 21

22 The Solution Compliance Tool: 340B provides simple way to manage self-audits and prepare for annual independent audits and attestations Built by Pharmacy Stars, a leader in application development for pharmacies Backed up by Visante s expert consulting and audit services 22

23 Compliance Tool:340B Central, HIPAA compliant storage of all 340B audit documentation and supporting material 15 individual tasks, each with self-audit protocol, review performance, Visante-defined risk score Reviewers perform self-audit for each section, collecting information, assessing compliance and reviewing transactions Includes upload option to store important program and audit documents in the central repository Approvers check and certify each completed self-audit to ensure accuracy Authorizing Officials review overall audit and compliance results and complete attestation 23

24 ComplianceTool:340B Audit Assignment 24

25 How 340B Compliance Tool works Reviewer Taskview 25

26 Compliance Tool:340B Approver Taskview 26

27 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 27

28 Questions? 28