Agenda


  • Morning Workshop – Government Pricing Programs 101

    Overview
    This workshop is designed for professionals either new to Medicaid Rebates operations or senior leaders looking for a course for basic understanding of MDRP Compliance for manufacturers. Titles include Government/Medicaid/Commercial Contracting and pricing, financial operations and legal. After attending the workshop, delegates will feel more comfortable and understand what the requirements are to participate in the various government programs including 340B, Medicaid Drug Rebates, Medicare Part D, Tricare and State programs. In addition, attendees will understand how manufacturer’s commercial activities drive the various elements that go into government programs. Attendees will also feel more comfortable with definitions, calculations and reporting requirements of government programs.

     

    8:30 am – Workshop Registration

    9:00 am – Workshop Begins

    10:30 am – 20-Minute Break

    12:30 pm – Workshop Concludes

     

    Part A – Introduction

    • Manufacturers’ commercial activity and Government Program
    • Understanding the language and acronyms

     

    Part B – Government Pricing Basics
    Learn the definitions, methodologies and calculations of:

    • Average Manufacturer’s Price (AMP)
    • Best Price (BP)
    • Unit Rebate Amount (“URA”)/ Rebate Per Unit (RPU)
    • 340B – Public Health Services (PHS) Pricing
    • Average Sales Price (ASP)
    • Non-Federal Average Manufacturer’s Price (Non-FAMP)
    • Federal Ceiling Price (FCP)
    • Federal Supply Schedule Price (FSS)

     

    Part C – Other Programs
    Other program processes, regulations and challenges with:

    • Medicaid Drug Rebate Claims
    • State Reporting Requirements
    • Tricare Agreements and Contacts
    • Medicare Part-D
    • Coverage Gap Rebates (Donut Hole)
    • Additional State Programs SPAP

     

    Part D – Compliance for Pharmaceutical Manufacturers

    • OIG recommendations
    • Data retention requirements
    • Reporting and certification  requirements
    • Industry best practices

     

    Part E – System Requirements and Integration

     

    Workshop Speaker

    Catrina Hirschauer
    Contract and Government Reporting Specialist, Upsher-Smith Laboratories

    Katie Lapins
    Principal, Government Pricing Specialists, LLC


  • Afternoon Workshop – 340B Program Policies, Operational Answers, and Audit Findings

    Overview
    This workshop is designed for professionals working in government and commercial contracting from manufacturers and pbms. Specific titles include Government and commercial contracting, pricing and reimbursement, 340B operations and commercial contracting.

    1:15 pm – Workshop Registration

    1:30 pm – Workshop Begins

    3:00 pm – 20-Minute Break

    5:00 pm – Workshop Concludes

     

    Part A – 340B Program Fundamentals

    340B Program Fundamentals

    • Describe HRSA’s role within 340B Program
    • Discuss eligible covered entities types
    • Describe statutory requirements for participation (Manufacturers, covered entities (DSH vs other), GPO prohibition, duplicate discount, diversion)
    • Discuss drug pricing calculatins and administration basics (roles of manufacturer and wholesalers)
    • Describe Apexus – 340B Prime Vendor Program’s roles (Services offerings for covered entities and services offered for manufacturers)
    • Discuss HRSA’s integrity initiatives (Recertification, audits of covered entities and manufacturers and reported result)

    Mike Benedict
    Vice President of Operations, Apexus

    Part B – Medicaid, Duplicate Discounts & Diversion: Manufacturer risks and approaches

    • Present a brief overview of the challenges for stakeholders with duplicate discount prevention
    • Describe strategies used by manufacturers to identify
      duplicate discounts and diversion
    • Present case studies of strategies used to resolve duplicate discounts and diversion
    • Dispute resolution with state Medicaid agencies

    Aaron Vandervelde
    Director, Berkeley Research Group

    Part C – Building 340B expertise within your company and engaging covered entities to minimize risk

    • Discuss the costs of entity non-compliance for manufacturers
    • Describe how manufacturer peers are approaching self-disclosures and dealing with HRSA audit results
    • Present strategies for handling entity repayments to manufacturers

    George Kenny
    Associate Director, 340B Account – Management, Genentech

    Part D – 340B Hot Topics addressed by panelist

    • Discuss unique challenges with Medicaid rebate and 340B drug pricing obligations
    • Discuss challenges with contract pharmacy arrangements
    • Discussion of challenges with HRSA database, exclusion file, and chargeback processing
    • Other

    Moderator:
    Chris Hatwig
    President, Apexus

    and

    Panelists:
    Mike Benedict
    Vice President of Operations, Apexus

    Kathleen Black
    Director, Government Strategy, Pfizer

    George Kenny
    Associate Director, 340B Account – Management, Genentech

    Aaron Vandervelde
    Director, Berkeley Research Group

Agenda

Healthcare Trends and Policy Expectations

  • 8:00 am

  • Registration & Breakfast

  • 8:30 am

  • Conference Chairperson’s Opening Remarks

    Lorraine Moccio
    Director, Government Contracting and Pricing Compliance Officer, Johnson & Johnson International

  • 8:35 am

  • Industry Trends and Policy Expectations Impacting Government Drug Programs

    • PhRMA policy expectations for 340B Program in the next year
    • How the shift to Accountable Care Organization model will impact reimbursement systems
    • Demonstrate value throughout drugs lifecycle for future pricing metrics
    • PBM industry trends and updates to improve nationals healthcare delivery system
    • Changing role of Contract Pharmacy and Specialty Pharmacy for manufacturers rebates

    Maya Bermingham
    Vice President, Law Department, PhRMA

    Laurel Todd
    Managing Director, Reimbursement and Health Policy, BIO

  • 9:05 am

  • 340B Program Updates for 2015

    • Information on the Proposed Rules for 2015
    • How to use covered entity audits findings from HRSA
    • Manufacturer audits from HRSA

    CDR Krista M. Pedley, PharmD, MS
    Director, HRSA, Office of Pharmacy Affairs

  • 9:40 am

  • 340B Prime Vendor Goals and Services to Streamline 340B Operations for Manufacturers

    Chris Hatwig, M.S., R.Ph., FASHP
    President, APEXUS/ 340B Prime Vendor

  • 10:10 am

  • Overview of OIG Audits and Evaluations of 340B Data

    • OIG Audits of Manufactures for 340B
    • OIG Contract Pharmacy Evaluation
    • OIG Medicaid Managed Care and 340B Evaluation

    Ann Maxwell
    Assistant Inspector General for Evaluations, Office of Evaluation and Inspections, Office of Inspector General

  • 10:40 am

  • Networking Break

  • 11:10 am

  • What to Watch for in 2015: How to Plan for What We Don’t Know

    • HRSA plans to collect pricing information from manufacturers to verify the accuracy of 340B ceiling prices, as required by the Affordable Care Act
    • Challenges as States move from FSS to Medicaid MCOs
    • How Medicare Part D Co-Pay Mitigation may induce a false claims violations

    Alice Valder Curran
    Partner, Hogan Lovells

  • 11:45 am

  • Compliance Exposures Affecting Government Programs for Manufacturers

    • AMP Final Rule:What we know, what we don’t know and what we can do about it
    • Federal appeals court rulings on State Based Exchanges
    • IRS Final Branded Prescription Drug Fee Regulations changes

    John Shakow
    Partner, King & Spaulding

  • 12:15 pm

  • Case Study: Daiichi Sankyo Collaboration Case Study on 340B Contract Pharmacy Data

    In 2014, Daiichi Sankyo along with IMS Health data and the Managed Care Organization involved started a project to analyze contract pharmacy data for the 340B program. The purpose was to identify the percentage of sales for inaccurate categories, double dipped or diverted. These results will help you to know how and what to examine with your own contract pharmacy data.

    Jeremy Docken
    Director of Operations, Managed Markets Services – Data Niche Division, IMS Health

    Edward J. McAdam Sr.

    Senior Director, Payer Market and Contract Strategy, Daiichi Sankyo

  • 1:00 pm

  • Luncheon

  • 2:00 pm

  • Bona Fide Service Fees and Fair Market Value

    • Classification of Fees vs. Price Concessions
    • Definition of Bonafide Service Fees
    • Designations of BFSFs vs. Personal Services and GPO Safe
    • How to Get to Fair Market Value
    • Understand BFSFs in Medicare Part D

    Stephanie Trunk
    Partner, Arent Fox LLP

  • 2:30 pm

  • Bridge Commercial Contracting Strategy with Government Program Rules

    • Evaluate GP impact from commercial contracting initiatives and proposals
    • Keep commercial and government contracting strategies current
    • Constraints and compliance in balancing regulatory, business and GP Functions
    • Determine actual revenue recognition and discuss Gross-to-net computations, Fair market value (FMV), and Script level validations

    Paula Martins
    Director, Government Contracts, Daiichi Sankyo

    Jay McKinley
    Senior Director, Government Pricing and Commercial Operations, Dendreon

    Lorraine Moccio
    Director, Government Contracting and Pricing Compliance Officer, Johnson & Johnson International

  • 3:00 pm

  • Contracting and Invoicing Lessons from Oklahoma State Supplement Rebate Program

    This session describes how Oklahoma runs their supplement rebate program including contract submission, review of contracts, and invoicing.

    Stacey Hale
    Drug Rebate Manager, Oklahoma Health Care Authority (Oklahoma)

    Kerri Wade
    Pharmacy Operations Manager, Oklahoma Health Care Authority (Oklahoma)

  • 3:30 pm

  • Networking Break

  • 3:45 pm

  • Government Pricing 2020: The Government as a Customer

    This extended session will delve into the government’s role as a customer for pharmaceutical companies. Discussion focuses on how the landscape is evolving and what that means for profits, staffing, and compliance risks once the ACA and other recent legislation are fully implemented and in practice for several years. Attend this session for a better, longer term, understanding of what the situation will be in 2020, and to explore:

    • How will the US government’s role as a customer and driver of pharmaceutical sales evolve in the next 5 years?
    • What impact to commercial margins and commercial sales practices will government policy continue to have?
    • Beyond the upcoming AMP rule, what other regulatory changes may the government impose on pharmaceutical manufacturers over the next five years?
    • What proposals are being discussed on the Hill? What can manufacturers do to stay informed, prepare, and provide input?

    Anne Dessertine
    Partner, Lincoln Consulting

    Jesse Mendelsohn
    MODEL N

    John Shakow
    Partner, King and Spaulding

  • 5:15 pm

  • Networking Reception

Agenda

Compliant Government Pricing Programs

  • 8:00 am

  • Breakfast

  • 8:50 am

  • Conference Co-Chairs’ Opening Remarks

    Jay McKinley
    Senior Director, Government Pricing and Commercial Operations, Dendreon

    Lorraine Moccio
    Director, Government Contracting and Pricing Compliance Officer, Johnson & Johnson International

  • 9:00 am

  • News from the Hill: What the New Congress Means for the 340B program

    Maureen Testoni
    General Counsel, SNHPA

  • 9:30 am

  • New OIG Reports on Supplemental Rebates and Offset Rebates

    David Tawes
    Regional Inspector General, Baltimore Regional Office, Office of Inspector General (OIG)

    Rob Vito
    Regional Inspector General, Baltimore Regional Office, Office of Inspector General (OIG)

  • 10:00 am

  • Government Agencies Impact Your Drug Rebate Compliance and Operations

    • FDA NDC File Verification requirement for CMS DDR Listings
    • NCPDP standards for streamlined data verification with duplicate discounts for 340B, unit of measure and 340B identifiers
    • HRSA collecting drug pricing data from manufacturers for verification of the accuracy of 340B ceiling prices
    • FDA Generic User Fees
    • CMS, OPA and DHA/VA Price data interactions

    Lisa McNair
    Manager, Contracting and Reimbursement, Indivior

    Stephen C. Mullenix, RPh
    SVP, Public Policy and Industry Relations, National Council for Prescription Drug Programs (NCPDP)

    Sandra Sandiford
    Finance Rebate Administrator, Indivior

  • 10:30 am

  • Networking Break

  • 10:45 am

  • Contract Pharmacy and Specialty Pharmacy Perspectives on Medicaid Rebates and 340B Program

    • How pharmacies, specialty pharmacies, and PBMs are changing manufacturer financial forecasts
    • Compliance requirements for contract pharmacy arrangements
    • Covered entities on data oversight and improving operational compliance
    • Regulation update on pharmacy classification: wholesalers, distributors, specialty pharmacies and contract pharmacies

    Don Bell
    SVP and General Counsel, National Association Chain Drug Store (NACDS)

    Andrew Wilson
    VP, 340B Solutions, McKesson

  • 11:15 am

  • Prosecutor’s Insights on 2014 Manufacturer Enforcement Actions

    • Discuss Anti-Kickback cases and why they were brought on
    • Why companies and individuals were recently prosecuted
    • Top incorrect assumptions and why they lead to investigations

    Moderator:
    Michele Sartori
    Practice Manager, Investigations, White Collar and Fraud Group, Hogan Lovells

    Panelist:
    Gregg Shapiro
    Assistant US Attorney, US Attorney’s Office, District of MA

  • 11:45 am

  • Pick up lunch and bring back to session for Luncheon session

  • 11:55 am

  • Luncheon Session: Manufacturers Navigate Compliant Government Contracting

    • How to handle the operational ambiguity of MDRP and 340B programs
    • Identify new accruals and liabilities in Medicaid and Medicare Part D
    • Federal Upper Limit (FUL) methodology based on AMP
    • New rules for IRS-Branded Prescription Drug Fee calculations
    • Data integrity best practices from beginning through certification process
    • Bona fide Service Fee classifications and Fair Market Value

    Kathleen Black
    Government Contracts Compliance, Pfizer

    Michael Hepburn
    Senior Director, Government Contract Compliance, Janssen Pharmaceuticals

    Danielle Naim
    Senior Manager, Government Pricing and Policy, Daiichi Sankyo

  • 12:45 pm

  • Conference Concludes