Key Takeaways from the Winter 340B Coalition Conference › wp-content › uploads › 2016 › ...Key Takeaways from the Winter 340B Coalition Conference Kristin Fox-Smith, MPA

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Key Takeaways from the Winter 340B Coalition Conference Kristin Fox-Smith, MPA Douglas E. Miller, PharmD Tony Zappa, PharmD, MBA February 25, 2016


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


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


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 2007


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


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


New AMP Rule

•  Proposed rule published Feb. 2012 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


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?


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


HRSA Audits of Covered Entities

•  HRSA audits started in 2012

•  74% 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


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


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


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


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


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 28-30 claims over 6 month period

–  Use a random sample generator


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


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)


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


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


•  Covered entities consistently struggle with managing and performing self-audits, 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

Compliance: Increasing Challenge


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


•  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

The Solution


•  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

Compliance Tool:340B


ComplianceTool:340B

Audit Assignment


How 340B Compliance Tool works

Reviewer Taskview


Compliance Tool:340B

Approver Taskview


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


Questions?

Documents

Key Takeaways from the Winter 340B Coalition Conference › wp-content › uploads › 2016 › ...Key Takeaways from the Winter 340B Coalition Conference Kristin Fox-Smith, MPA