MEDICAID REBATE SUMMIT - The Conference Forum · 2014. 2. 26. · TO REGISTER, VISIT OR CALL 646-350-2580 Welcome to the Medicaid Rebate Summit (MRS), a strategic-level forum for

TO REGISTER, VISIT WWW.THECONFERENCEFORUM.ORG OR CALL 646-350-2580

2014 KEY TOPICS ADDRESSED

MEDICAID REBATE SUMMITA strategic-level forum for manufacturers contracting with MDRP, 340B, Medicare Part D, and states

FEBRUARY 26 - 27, 2014 PARK HYATT WASHINGTON, WASHINGTON, DC

2014 Medicaid Keynote:Adam Fein, PhDPresidentPembroke Consulting andAuthorDrug Channels

Guest VIP AMP Final Rule Speaker:Alice Valder CurranPartnerHogan Lovells

340B Policy Speaker:CDR Krista Pedley, PharmD, MSDirectorHRSA, Office of Pharmacy Affairs

Final Rule Clarification●

Medicaid Expansion Impact●

AMP Calculations, Best Price and Key

Pharmacy Reimbursement Issues●

Alternative Rebate Calculation for Line Extensions●

340B Program Operations, Audits and

Compliance Clarification●

Bona Fide Service Fees and How they Should be

Evaluated for Fair Market Value (FMV)

Medicaid Rebate Liability Responsibility Updates●

Invoices and Reporting Regulations ●

Government Contracting and Strategies●

Medicare Part D, State Exchanges,

State Rebate Initiatives●

Strategic Government Business Contracting

and Analysis ●

Tools/Software for Complex Pricing Structures

Organized byCo-Sponsor

Co-Chair:Jim Abrams, MBADirector, Government Pricing & ReportingMylan Pharmaceuticals

Co-Chair:Stephanie KupskiSenior Director Managed Markets & HCP ComplianceIroko Pharmaceuticals

Executive Sponsor Associate Sponsors

http://WWW.THECONFERENCEFORUM.ORG



Welcome to the Medicaid Rebate Summit (MRS), a strategic-level forum for manufacturers contracting with MDRP, 340B, Medicare Part D, and states. With the anticipation of the AMP Final Rule, this conference will cover the most up-to-date information available to help you stay current with the responsibilities in administering and managing the MDRP and other related programs.

If you are looking to understand how government programs impact commercial contracting, this event provides the implementation, operations and compliance answers for the changing GP environment. Guided by industry veterans, the MRS conference is designed for all size manufacturers, covering:

• How Medicaid will shape pharma’s financial future

• Policy and operations answers for Covered Outpatient Drugs AMP Final Rule

• AMP Final Rule interpretations, key issues and implementation challenges

• 340B program integrity initiatives, audit reporting and case studies

• Two new reports on MACs from the Office of Inspector General

• Current civil and criminal enforcement actions and perspectives from an in house counsel, defense firm, and Federal and State prosecutors

• New requirements of IRS branded fee, Sequestration, and Sunshine Act reporting requirements and their impact GP and Commercial contracting

• State Insurance Exchanges and Medicaid Expansion updates

• Medicare Part D Donut Hole Challenges

• Individual State Medicaid invoice and reporting requirements

• Strategic commercial contacting insights including Gross to Net Analysis

We look forward to seeing you on February 26 in Washington, DC.

Sincerely,

Anne ReelConference Director

Valerie BowlingExecutive Director

Jim Abrams, MBADirector, Government Pricing & ReportingMylan Pharmaceuticals, Inc.

Alice Valder CurranPartnerHogan Lovells

Heather DixsonDirector, Government Price ReportingEli Lilly

Paula GristDirector, Government Reporting Hospira

Richard Holsapple, RPhPharmacy Services Manager, Oregon MMISHP Enterprise Services

Stephanie KupskiSenior Director Managed Markets & HCP ComplianceIroko Pharmaceuticals

Edward J. McAdam Sr.Senior Director, Contracting Pricing and AnalyticsDaiichi Sankyo, Inc.

Jay McKinleySenior Director, Government Pricing and Commercial OperationsDendreon

Lorraine MoccioDirector, Government Contracting & Pricing Compliance OfficerJohnson & Johnson International Inc.

LaDonna SteinerAssociate General CounselPurdue Pharma

MEDICAID REBATE SUMMIT OVERVIEW

OVERVIEW

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CONFERENCE LEADERSHIP




Jim Abrams, MBADirector, Government Pricing and ReportingMylan Pharmaceuticals

Samone AngelDisabled & Elderly Health Programs GroupDHHS, CMS

Don BellSVP & General CounselNational Association of Chain Drug Stores (NACDS)

Michael Benedict, RPh, MSVP OperationsApexus/340B Prime Vendor Program

Kathleen BlackDirector, Government StrategyPfizer

Tamara BruceTechnical Director, Disabled & Elderly Health Programs GroupDHHS, CMS

Joann ButeSenior Manager, Government Pricing and ComplianceAmneal Pharmaceuticals

Dona CoffmanTechnical Director, Data and System GroupDHHS, CMS

Alice Valder CurranPartnerHogan Lovells

Heather DixsonDirector, Government Price ReportingEli Lilly & Co.

Adam Fein, PhDPresidentPembroke Consulting

Kristine FlynnGovernment PricingWockhardt USA

Virginia GibsonPartnerHogan Lovells

Paula GristDirector, Government Reporting Hospira

Sharon Halsey McLaughlin, RPhRetired-Pharmacy DirectorNC Medicaid

Christopher A. Hatwig, MS, RPh, FASHPPresidentApexus/ 340B Prime Vendor Program

Michael HepburnSenior Director, Government Contract ComplianceJanssen Pharmaceuticals

Richard Holsapple, RPhPharmacy Services Manager, Oregon MMISHP Enterprise Services

Kimberly HowellDeputy Director, Disabled & Elderly Health Programs GroupDHHS, CMS

Mandy HunterMedicaid RebatesHP Enterprise Service

George KennySenior Account Manager, 340B, Managed Care and Customer OperationsGenentech, Inc.

Stephanie KupskiSenior Director Managed Markets & HCP ComplianceIroko Pharmaceuticals

Miree Lee, MS, MBABio Pharma Pricing & Contracts ConsultantM. Lee Consulting, LLC

Paula MartinsDirector, Government ContractsDaiichi Sankyo, Inc.

Edward J. McAdam Sr.Senior Director, Contracting Pricing and AnalyticsDaiichi Sankyo, Inc.

Jay McKinleySenior Director, Government Pricing and Commercial OperationsDendreon

Lorraine MoccioDirector, Government Contracting & Pricing Compliance OfficerJohnson & Johnson International Inc.

LT Lawrence MomoduProgram Management OfficerHRSA Office of Pharmacy Affairs

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CONFERENCE LEADERSHIP MEDICAID REBATE SUMMIT

SPEAKING FACULTY




Stephen Mullenix, RPhSVP, Public Policy & Industry RelationsNational Council for Prescription Drug Programs (NCPDP)

Danielle NaimSenior Manager, Government PricingDaiichi Sankyo

Roann NicholsAssistant US Attorney, Civil DivisionDistrict of Maryland

Jennifer NortonSenior Director, Pricing & Contract Administration - Managed MarketsVertex Pharmaceuticals, Inc.

Joshua O’HarraAssistant General CounselEli Lilly

Viveca ParkerAssistant US Attorney, Civil Division United StatesEastern District of PA

CDR Krista M. Pedley, PharmD, MSDirector, HRSAOffice of Pharmacy Affairs

LaDonna SteinerAssociate General CounselPurdue Pharma

Laurel Todd, MBAManaging Director, Reimbursement & Health PolicyBiotechnology Industry Organization (BIO)

Cynthia TudorDirector, Medicare Drug BenefitCMS

Robert VitoRegional Inspector General in the Baltimore Regional OfficeOffice of Inspector General (OIG)

Stephanie YeagerOffice of Evaluation and InspectionsOffice of Inspector General (OIG)

8:00 am Registration & Breakfast

8:30 am Conference Chairs’ Opening Remarks

Jim Abrams, MBADirector, Government Pricing and Reporting, Mylan Pharmaceuticals

Stephanie KupskiSenior Director Managed Markets & HCP Compliance, Iroko Pharmaceuticals

10:00 am Policy and Operations Answers for Covered Outpatient Drugs, AMP Final Rule

This session addresses:

• What considerations led to the final rule policy

• Current operational challenges with CMS Medicaid representatives

MEDICAID REBATE SUMMIT SPEAKING FACULTY

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DAY ONE - WEDNESDAY, FEBRUARY 26, 2014

9:00 am 2014 Keynote:How Medicaid Will Shape Pharma’s Future

Dr. Fein is one of the country’s foremost experts on pharmaceutical economics and channel strategy. In this thought-provoking keynote, Dr. Adam J. Fein addresses:

• Key drug channel trends

• New organizational and compliance challenges from market developments

• How Pharmacies, Specialty Pharmacies, PBM’s will be affected after full implementation of the Affordable Care Act

• Will CMS use AMP-based FUL’s and how that might affect Pharmacy

• POV on Bona Fide Service Fees and how they should be evaluated for Fair Market Value (FMV)

Adam Fein, PhDPresident, Pembroke Consulting

9:30 am Q&A with Audience

Adam Fein, PhDPresident, Pembroke Consulting




• Explanation of the process for recalculation of Base Date AMPs

• Definition of retail community pharmacy (RCP)

• Criteria for eligible sales of traditional (non-5i) AMP calculations

• Class of Trade definitions and assignments including PBM-owned RCPs

• Clarification of 5i “not generally dispensed” in Retail Community Pharmacy classification

• The new Bona Fide Service Fees (BFSFs) categories and Authorized Generics

Kimberly HowellDeputy Director, Disabled & Elderly Health Programs Group, DHHS, CMS *

Samone AngelDisabled & Elderly Health Programs Group, DHHS, CMS *

Tami BruceDisabled & Elderly Health Programs Group, DHHS, CMS *

Dona CoffmanTechnical Director, Data and System Group, DHHS, CMS *

* Invited presenters

10:45 am Networking Break

11:15 am Alice Valder-Curran, our 2013 Keynote, Uncovers the Most Complicated Interpretations from the AMP Final Rule

Topics include:

• Determining the effect of Bundled Sale Definition on reimbursement rates

• Uncovering the financial impact of exclusive approval for pediatric indications

• Deciphering the process for Medicaid coverage of investigational drugs and patient program exclusion criteria

• Identifying the top ten most complicated aspects of the AMP Final Rule

Alice Valder CurranPartner, Hogan Lovells

12:30 pm Q&A with Audience

Alice Valder CurranPartner, Hogan Lovells

12:30 pm Manufacturers’ Panel on Government Contracting and Strategy Considerations for AMP Final Rule

• Operational and methodology impact of the final rule

• Strategies to ensure accurate rebates when recalculating the use of two AMP formulas to avoid payment of additional rebates

• AMP system implementation challenges and considerations

• The operational and financial implications of Territory Expansion and other changes

Jim Abrams, MBADirector, Government Pricing & Reporting, Mylan Pharmaceuticals, Inc.

Kathleen BlackDirector, Government Strategy, Pfizer

Paula GristDirector, Government Reporting, Hospira

Michael HepburnSenior Director, Government Contract Compliance, Janssen Pharmaceuticals

1:15 pm Luncheon

2:15 pm Networking Roundtable Consultation Session

The Medicaid Rebates Consulting session is designed to give all attendees an opportunity to meet one-on-one or in small group meetings to get specific questions answered. Attendees are free to rotate the table choices.

• Table A: Attorney Advice

• Table B: Systems Solutions

• Table C: Consulting Services

• Table D: Government Advice

2:50 pm Transition to Track Room

Afternoon Track Choices:

Track AOperational and Compliance Lessons for Medicare Part D & State Rebate Initiatives

Track BStrategic Government Business Contracting and Analysis

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AGENDA MEDICAID REBATE SUMMIT




MEDICAID REBATE SUMMIT AGENDA

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Track AOperational and Compliance Lessons for Medicare Part D & State Rebate Initiatives

Chaired by:

Richard Holsapple, RPhPharmacy Services Manager, Oregon MMIS, HP Enterprise Services

Track BStrategic Government Business Contracting and Analysis

Chaired by:

Jennifer NortonSenior Director, Pricing & Contract Administration - Managed Markets, Vertex Pharmaceuticals, Inc.

3:05 pm Gross to Net Analysis to Capture Net Government Business

• Pinpoint the essential data points in true gross-to-net analysis to classify all government purchases

• Understand the adjustments to gross-to-net revenue for Medicaid & Medicare rebates as a result of healthcare reform

• Define cumulative rebates and identify “double dipping” risks for Medicaid Rebate, Medicaid Supplemental, Medicaid Managed Care and 340B


3:05 pm Update on State Insurance Exchanges and Medicaid Expansion

• Trends in managed care and government programs

• New models of delivery/payment and medication management

• Obstacles in Healthcare Exchange implementation and operations

LaDonna SteinerAssociate General Counsel, Purdue Pharma

3:45 pm Networking Break

3:45 pm Networking Break

4:15 pm Regulatory and Operational Solutions for Medicare Part D Donut Hole Challenges

• Uncover new donut hole closure timelines for branded drugs and estimate the impact on your organization

• Obtain complete validation results to stop MMCO rebate overpayments

• Improve data validation and double dipping for third party data integration

• Avoid civil monetary penalties and learn to handle disputes and appeal process efficiently

Cynthia TudorDirector, Medicare Drug Benefit and C&D Data Group Medicare, CMS *

4:15 pm GP Systems and Tools for Complex Pricing Structures for Improved Compliance

• Avoid costly mistakes from manual processes and improve resource allocation

• Control revenue leakage from customer incentives

• Improve data management and calculations for government programs



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4:45 pm Operational Strategies for State Medicaid Rebate Invoices and Reporting Regulations

• Strategies for overcoming manufacturer staffing challenges for processing the ongoing additional State MMCO invoices

• Managing the accrual and true-up process including explanations of any variances from the California or other State invoices

• Assumptions and adjustments necessary for California and other state claims data

• The impact of additional MMCO invoices have on open/current disputes

• Reporting compliance changes for multiple states

• Specific state procedures for:

- Physician Administered Drug (PAD) Encounter Claims

- Claim Level Detail

- Invoicing and rebate payments

- Dispute processes

- MCOs and the 340B Program

- Supplemental rebates

- SPAPs and SCHIPS

Sharon Halsey McLaughlin, RPhRetired-Pharmacy Director, NC Medicaid

Richard Holsapple, RPhPharmacy Services Manager, Oregon MMIS,HP Enterprise Services

Mandy HunterMedicaid Rebates, HP Enterprise Service

4:45 pm Bridging Commercial Contracting Strategy with Government Program Rules

• Evaluate GP impact from commercial contracting initiatives and proposals

• Ensure commercial and government contracting strategies

• Determine actual revenue recognition and discuss:

- Gross-to-net computations

- Bona fide service fees (BFSF)

- Fair market value (FMV)

- Script level validations

Paula MartinsDirector, Government Contracts, Daiichi Sankyo, Inc.

Lorraine MoccioDirector, Government Contracting & Pricing Compliance Officer, Johnson & Johnson International Inc.


5:30 pm Networking Reception

5:30 pm Networking Reception




8:15 am Breakfast

8:45 am Chairs’ Opening Remarks

Jim Abrams, MBADirector, Government Pricing and Reporting, Mylan Pharmaceuticals

Stephanie KupskiSenior Director Managed Markets & HCP Compliance, Iroko Pharmaceuticals

9:00 am 340B Program Operational and Compliance Clarification: A Key Focus for Congress

The 340B drug discount program has received unprecedented attention from Congress, regulators and the national media. Meet with HRSA officials, OIG and a Prime vendor to hear the most up-to-date information on the 340B program to ensure compliance and operational effectiveness.

• Program integrity initiatives

• Avoid double dipping

• Explanation and implementation of GPO prohibition

• Medicaid Exclusion File Provision

• Covered Entities Audit Report

Moderator:Michael Benedict, RPh, MSVP Operations, Apexus/340B Prime Vendor Program

Panelists:Christopher A. Hatwig, MS, RPh, FASHPPresident, Apexus/ 340B Prime Vendor Program

George KennySenior Account Manager, 340B, Managed Care and Customer Operations, Genentech, Inc.

LT Lawrence MomoduProgram Management Officer, HRSA Office of Pharmacy Affairs

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

9:55 amThe Pharmacy Voice on Current and Future Reimbursement Methodologies: Updates and Actions

• Perspective on the covered outpatient drugs regulation

• The impact of regulation on pharmacy classification, wholesalers, distributors, specialty pharmacies and retail community pharmacy definition

• The impact of the Retail Community Pharmacy (RCP) definition

• Should manufacturers include or exclude the deduction of customary prompt pay discounts to wholesalers from ASP?

Don BellSVP & General Counsel, National Association of Chain Drug Stores (NACDS)

Stephen Mullenix, RPhSVP, Public Policy & Industry Relations, National Council for Prescription Drug Programs (NCPDP)

10:35 am Bio/Pharma Industry Pricing and Policy Trends

Discussion and interview with:

Laurel Todd, MBAManaging Director, Reimbursement & Health PolicyBiotechnology Industry Organization (BIO)

11:00 am Networking Break

11:30 am OIG REPORT: Federal and State Maximum Allowable Cost or MAC Report

New details are presented from a report on the in-depth investigation of Federal and State Maximum Allowable Costs (MACs) performed by the Office of Inspector General.

Robert A. VitoRegional Inspector General for Evaluation and Inspections, HHS, OIG *

Stephanie YeagerRegional Inspector, HHS, OIG *

* Invited Speaker

MEDICAID REBATE SUMMIT AGENDA

8

DAY TWO - THURSDAY, FEBRUARY 27, 2014




12:00 noon Prosecutors Discuss 2013 Civil and Criminal Enforcement Actions in Medicaid Pricing

Perspectives of an in-house counsel, a defense firm and government prosecutors who provide information on current civil and criminal enforcement actions and recent settlements to help manufacturers stay compliant. More specifically:

• Understand why companies and individuals were recently prosecuted

• Identify the top incorrect assumptions and why they lead to investigations

• Discuss recent Qui Tam and Sunshine Act settlements

Moderator:Virginia GibsonPartner, Hogan Lovells

Panelists:Roann NicholsAssistant US Attorney, Civil Division, District of Maryland

Joshua O’HarraAssistant General Counsel, Eli Lilly & Co.

Viveca ParkerAssistant US Attorney, Civil Division United States, Eastern District of PA

12:45 pm Luncheon Break

1:45 pm Bridging It All Together

How to Eliminate Silos in Managing GP Changes: Creating a Team Approach for Faster and More Efficient Implementation

It takes a village and then some to manage GP changes. When was the light bulb moment when you realized how many people really need to care about government pricing? How do you get others in your organization to care? What language do you use and what is the message to all of the stakeholders?

In this concluding afternoon session, we bring together real examples from IT, Sales & Marketing, Finance, GP, Compliance/Legal and Contracting and their perspectives on the impact of all departments.

This session will be partly led by select stakeholders followed by group table discussions on specific industry

changes and their impact across departments. More specifically:

• Price increases

• Methodology change

• Regulatory change

• System changes

• Merger and acquisition

At the conclusion of this session participants will have a better understanding of the following:

• The impact of government program changes on internal colleagues

• How to navigate the process of managing change so that you are not working in a silo

• Improve communications among all stakeholders

• Proposed solutions

Group Leader:Miree Lee, MS, MBABio Pharma Pricing & Contracts ConsultantM. Lee Consulting, LLC

Drug Pricing PolicyDanielle NaimSenior Manager, Government Pricing, Daiichi Sankyo

Government Contracts & PricingStephanie KupskiSenior Director Managed Markets & HCP Compliance, Iroko Pharmaceuticals

Government PricingKristine FlynnGovernment Pricing, Wockhardt USA

4:00 pm Conference Concludes

9





Standard Conference $1,795

The conference fee includes the program, morning coffee/tea, luncheons and conference documentation.

Full time Government and Non-Profit Employee Rate: $495. For more information on registration and pricing, please contact [email protected].

Discount ProgramsGroup Registration – Receive a 10% discount off each registration when two or more colleagues from the same company register online.

Large group discounts available.

Please contact [email protected] or call 646-350-2580 for any questions on discount rates.

Payment PolicyPayment must be received in full by the event date. All discounts will be applied to the Conference Only fee (excluding add-ons)‚ cannot be combined with any other offer‚ and must be paid in full at the time of conference.

Substitution and Cancellation PolicyIf you are unable to attend and would like to register a substitute, please email [email protected]. Please ask your substitute to provide identification on-site.

If you need to cancel your registration, please note the following policies based on the start date of the event:

Ten or more business days prior: A full refund less the administration fee of $295, or a pass to another event valid for two years from the date of issue.

Less than ten business days prior: A pass to a future event for either yourself or a colleague from the same company valid for two years from the date of issue.

To cancel and receive a refund or pass, please email [email protected] or call 646-350-2580.

The Conference Forum GuaranteeThe Conference Forum guarantees the quality of its conferences. If you are not satisfied, a credit will be applied towards a comparable program.

Park Hyatt Washington24 & M Streets NW Washington, DC 20037202-789-1234parkwashington.hyatt.com

For reservations, call 888-421-1442 and ask for the Medicaid Rebate Summit group rate or use the following link: https://resweb.passkey.com/go/GTCFF.

The Park Hyatt Washington is a beautiful modern hotel conveniently located in the heart of Washington DC.

MEDICAID REBATE SUMMIT REGISTRATION / VENUE / SPONSORS

REGISTRATION VENUE

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CO-SPONSOR

MEDIA PARTNERS

EXECUTIVE SPONSOR

ASSOCIATE SPONSORS



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Documents

MEDICAID REBATE SUMMIT - The Conference Forum · 2014. 2. 26. · TO REGISTER, VISIT OR CALL 646-350-2580 Welcome to the Medicaid Rebate Summit (MRS), a strategic-level forum for