Key Takeaways from the Winter 340B Coalition Conference

Transcription

Key Takeaways
from the
Winter 340B Coalition Conference
Kristin Fox-Smith, MPA
Douglas E. Miller, PharmD
Tony
Zappa, PharmD, MBA
February 25, 2016
© Copyright Visante, Inc. All rights reserved | www.visanteinc.com
1
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
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
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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
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Medicaid
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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
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Medicaid Managed Care
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Medicaid Fee-For-Service (FFF)
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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
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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
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AMP Rule: Key Implications for 340B
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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?
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Contract Pharmacies
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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
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HRSA Audits of Covered Entities
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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
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HRSA Audits of Covered Entities
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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
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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
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Visante Audit Experiences
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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
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Internal Audits
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Quarterly Audits
–  In-house pharmacies
–  Contract pharmacies
–  Mixed-use areas
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Procedure
–  Listing of all prescriptions dispensed and/or medications administered
–  EHR chart review
–  Medication usage reports & purchases
• 
Annual independent audits
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Internal Audits
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Conduct sampling audit
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Trace claim from pharmacy claim back to the patient medical record
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Validate claim
–  Eligible patient
–  Eligible provider
–  Written at an eligible location
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Use statistical sample
–  Usually between 28-30 claims over 6 month period
–  Use a random sample generator
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Key Policies and Procedures
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Purchasing
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Inventory
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Invoice processing
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Contract pharmacy oversight
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Medicaid billing
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Patient eligibility qualifications
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Self-disclosure/material breach
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Organizational responsibilities of key personnel
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OPA Database
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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)
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Compliance Oversight
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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
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Visante’s Compliance Tool: 340B
A New Way to Manage Self-Audits
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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
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Self-Audits
Current State Desired State Audits performed as staﬀ have 2me or only when problems found Directed audit tasks based on monthly, quarterly and annual schedule Disorganized document reten2on and ﬁling Central repository for all 340B-‐related documents, including transac2onal audits P&Ps that are not updated with program changes Supported by industry experts with updates as program rules change Limited visibility by senior management to program performance High-‐level dashboard showing audit performance and program risk levels High risk of poor audit outcomes, including aCestor’s personal liability Minimal risk of poor audit outcomes © Copyright Visante, Inc. All rights reserved | www.visanteinc.com
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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
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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
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ComplianceTool:340B
Audit Assignment © Copyright Visante, Inc. All rights reserved | www.visanteinc.com
24
How 340B Compliance Tool
works
Reviewer Taskview © Copyright Visante, Inc. All rights reserved | www.visanteinc.com
25
Compliance Tool:340B
Approver Taskview © Copyright Visante, Inc. All rights reserved | www.visanteinc.com
26
Potential Areas of Synergy
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Comprehensive 340B Assessment &
Integrity Audit Readiness Review
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Annual Independent External Audit
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Other Visante Services
–  New and expanded retail
pharmacy services
–  Ambulatory clinical pharmacy
opportunities
–  Specialty pharmacy
–  Employee Rx benefit
–  Discharge prescription capture
27
Questions?
28

Key Takeaways from the Winter 340B Coalition Conference

Transcription

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