medicaid rebate summit - the conference forum€¦ · 26/02/2014 · customer operations...

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 by

Co-Sponsor

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

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

Executive Sponsors

Associate Sponsors Supporting Sponsor

http://WWW.THECONFERENCEFORUM.ORG



OVERVIEW

Welcome to the Medicaid Rebate Summit (MRS), a strategic-level forum for manufacturers contracting with MDRP, 340B, Medicare Part D, and states. 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

• AMP Final Rule preparations, key issues and implementation challenges

• 340B program double discounts, diverisons, integrity initiatives, and audit reporting

• Strategic commercial contacting insights including Gross to Net Analysis

• 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

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

Sincerely,

Anne ReelConference Director

Valerie BowlingExecutive Director

CONFERENCE LEADERSHIP

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 / CONFERENCE LEADERSHIP

2




SPEAKING FACULTY

Jim Abrams, MBADirector, Government Pricing and ReportingMylan Pharmaceuticals

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

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

Kathleen BlackDirector, Government StrategyPfizer

Joann ButeSenior Manager, Government Pricing and ComplianceAmneal Pharmaceuticals

Chris CobournSVP Commercial ComplianceCIS

Alice Valder CurranPartnerHogan Lovells

Heather DixsonDirector, Government Price ReportingEli Lilly & Co.

Tom EveganSenior Director, Commercial Contracting ServicesCIS

Adam J. Fein, PhDPresidentPembroke Consulting

Kristine FlynnGovernment PricingWockhardt USA

Joel FreimuthPresidentBlue Pearl Consulting

Virginia GibsonPartnerHogan Lovells

Sharon H. Greeson, RPhRetired - NC Medicaid & GP ConsultantCIS

Paula GristDirector, Government Reporting Hospira

David GilpertRevitas Business Solutions

Jeffrey HandwerkerPartnerArnold & Porter

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

Michael HepburnSenior Director, Government Contract ComplianceJanssen Pharmaceuticals

Kristen HicksAssociateArnold and Porter

Richard Holsapple, RPhPharmacy Services Manager, Oregon MMISHP Enterprise Services

Mandy HunterMedicaid RebatesHP Enterprise Service

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

Stephanie KupskiSenior Director Managed Markets & HCP ComplianceIroko Pharmaceuticals

Katie LapinsDirectorHuron Life Sciences

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.

Kris McGrawSolutions PrincipalModel N

3

SPEAKING FACULTY MEDICAID REBATE SUMMIT




Jay McKinleySenior Director, Government Pricing and Commercial OperationsDendreon

Scott MedberryDirector, Product ManagementModel N

Jesse MendelsohnDirector, Global Customer Services & SupportModel N

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

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

Michael PanicaroRevitas Business Solutions

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

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

Gregg ShapiroAssistant US Attorney, US Attorney's OfficeDistrict of Massachusetts

Larri ShortPartnerArent Fox LLP

LaDonna SteinerAssociate General CounselPurdue Pharma

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

Amy VanDeCarSenior PrincipalCumberland Consulting Group, LLC

Clay WillisManagerHuron Life Sciences

DAY ONE - WEDNESDAY, FEBRUARY 26, 2014

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

MEDICAID REBATE SUMMIT SPEAKING FACULTY / AGENDA

4

8:45 am 2014 Keynote:How Medicaid Will Shape Pharma’s Future

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

• Key drug channel trends

• New organizational and compliance challenges from market developments

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

• Will CMS use AMP-based FULs and how that might affect Pharmacy

Adam J. Fein, PhDPresident, Pembroke Consulting

9:30 am Q&A with Audience

Adam J. Fein, PhDPresident, Pembroke Consulting




9:45 am Alice Valder Curran, our 2013 Keynote, Back by Popular Demand, on How to Handle 340B Covered Entity Refunds and Address Preparations for AMP Final Rule

Topics include:

• HRSA Audits

• Covered Entity Refunds

• Contract Pharmacies

• The Mega-Rule

• Manufacturer Advocacy

Alice Valder CurranPartner, Hogan Lovells

10:30 am Q&A with Audience

Alice Valder CurranPartner, Hogan Lovells

10:45 am Networking Break

11:15 am 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

Moderator:Tom EveganSenior Director, Commercial Contracting Services, CIS

Panelists:

Kathleen BlackDirector, Government Strategy, Pfizer

Paula GristDirector, Government Reporting, Hospira

Michael HepburnSenior Director, Government Contract Compliance, Janssen Pharmaceuticals

12:00 noon Mapping out an AMP Final Rule Compliance Game Plan

Knowing the statutes and the policy updates from CMS is only one step in operationalizing the process. This session will discuss how current information from the proposed rule plus evaluation of business-specific factors such as data availability for US Territories, specific concerns around Pediatric drugs, RCP/nonRCP boundary products and other concerns can be mapped to current processes and systems. Using this mapping, once the final rule is published, a prioritized game plan can be implemented within the short timeline for compliance.

Scott MedberryDirector, Product Management, Model N

12:30 pm Hot Topics in Government Pricing Programs

• Lessons learned in Bona Fide Service Fee classifications

• Best practices for data integrity through the certification process

• The rules for IRS-branded Prescription Drug Fee calculations and dispute process for state Medicaid utilization

Jim Abrams, MBADirector, Government Pricing and ReportingMylan Pharmaceuticals

Heather DixsonDirector, Government Price ReportingEli Lilly

Jay McKinleySenior Director, Government Pricing and Commercial Operations, Dendreon

1:00 pm Luncheon

2:15 pm Networking Roundtable Consultation Session

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

5

AGENDA MEDICAID REBATE SUMMIT




Table A: Attorney Advice

A1 – Key assumptions for Bona Fide Service fees and Fair Market Value

Larri ShortPartner, Arent Fox LLP

A2 – 340B: Nuts and bolts for 340B covered entity oversight

Jeffrey HandwerkerPartner, Arnold Porter

Table B: Systems Solutions

B1 - Considerations for evaluating solutions – the top 5 questions you need to ask including system automations integration and compliance capabilities. Preparing for implementation – the top 5 questions you need to ask- including specific questions about scalability, planning, data requirements, and timelines

David GilpertRevitas Inc.

Michael PanicaroRevitas Inc.

B2 - Beyond Systems: The Right Staffing, Processes and Procedures.

The only constant about the regulatory environment we work in is change. Having solid and top notch systems is a given, but do you have the proper people and procedures around your system? We will discuss policy, staffing, and data requirements of a well formed GP organization. Additionally, we will share stories from the industry regarding both successful and challenged organizations and their associated benefits and risks. We will end with describing the “ideal” state all GP organizations should strive towards.

Jesse MendelsohnDirector, Global Customer Services & Support, Model N

Scott MedberryDirector, Product Management, Model N

Kris McGrawSolutions Principal, Model N

Table C: Consulting Services

C1 – Operational tips for Final Rule implementation, answering key questions

• Five common mistakes made in the Medicaid Rebate process, and the impact these mistakes have on the company

• How to avoid these common mistakes

• Minimizing the cost of fixing these mistakes

• How to set up your organization for the most effective Medicaid Rebate processing

Joel FreimuthPresident, Blue Pearl Consulting

C2 - Current Fiscal and Methodical Considerations including MMCO, Changing Payer Mix and 340B Program

• Shifts in the Payer mix with MMCO and HCX, and the expansion of Medicaid

• Medicaid and Medicare: An Overview of Healthcare Reform Impacts on Accruals and Liability

• Performing company specific Fiscal Impact analyses

• Effect of Medicaid Expansion and Exchanges on Calculating Gross-to-Net

• Bona Fide Service Fee evaluations- Mitigating Risk by getting documentation and assumptions in place

• 340B Program Integrity initiatives, including manufacturer audits

• GP systems assessment and audit to validate the integrity of the calculations, both historical and prospective under the Final Rule

Chris CobournSVP, Commercial Compliance, CIS

2:55 pm Transition to Track Room

Afternoon Track Choices:

Track A340B and State Operations

Track BStrategic Government Business Contracting and Analysis

MEDICAID REBATE SUMMIT AGENDA

6





Track A340B and State Operations

Track Chair:

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

Track BStrategic Government Business Contracting and Analysis

Track Chair:

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 Current Developments with 340B Program Audits, Assumption Letters and Orphan Drug Rule

• How the Affordable Care Act is impacting the 340B Statute including Orphan Drug Rule

• How to handle entity repayment processes and operations

• What you should be doing with assumption letters

• What you should be doing with HRSA covered entity audit results

LaDonna SteinerAssociate General Counsel, Purdue Pharma

Jeff HandwerkerPartner, Arnold and Porter

Kristen HicksAssociate, Arnold and Porter

3:45 pm Networking Break

3:45 pm Networking Break

7





4:30 pm Operational Strategies for State Medicaid Rebate Invoices and Reporting Regulations

• State Rebate Invoicing Challenges

• MCO Pharmacy/Physician Encounter Claims

• MCO claim level detail

• Handling MCO Rebate disputes

• 340B Program Challenges for FFS and MCO

• Specialty Pharmacy and 340B

Sharon H. Greeson, RPhRetired-NC Medicaid & GP Consultant, CIS

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

Mandy HunterMedicaid Rebates Team, HP Enterprise Services

4:30 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.


5:15 pm Networking Reception hosted by

4:00 pm Understanding How Commercial Contracts & Government Programs Intersect

Understanding the effect of commercial sales contracts on the federal market place and knowing areas of vulnerability can be a challenge. This session will provide concrete examples of how and why visibility and open communication throughout the revenue lifecycle are essential to keeping your company in compliance without adversely impacting the bottom-line. In this session, you will learn:

• How to minimize the impact of commercial pricing and discounting decisions on Government Pricing and federal rebate contracts

• Understanding your organization’s role in the big picture

David Gilpert Michael PanicaroRevitas Inc. Revitas Inc.

4:00 pm Leveraging Data to Optimize Your 340B Participation

• Make the most of the data available to you

• Analyze for anomalies

• Validate your own compliance

Amy VanDeCarSenior Principal, Cumberland Consulting Group, LLC

8




DAY TWO - THURSDAY, FEBRUARY 27, 2014

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 continues to receive unprecedented attention from Congress, regulators and the national media. 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.

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 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.


9




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

Greg ShapiroAssistant US Attorney, US Attorney’s Office, District of MA

12:30 pm Luncheon Break

1:30 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 Consultant, M. 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

3:45 pm Conference Concludes

VENUE

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.

AGENDA / VENUE MEDICAID REBATE SUMMIT

10



http://parkwashington.hyatt.com/

http://parkwashington.hyatt.com/

https://resweb.passkey.com/go/GTCFF

https://resweb.passkey.com/go/GTCFF


REGISTRATION

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.

EXECUTIVE SPONSORS

ASSOCIATE SPONSORS

SUPPORTING SPONSOR

CO-SPONSOR

MEDIA PARTNERS

REGISTRATION / SPONSORS MEDICAID REBATE SUMMIT

11



mailto:[email protected]








medicaid rebate summit - the conference forum€¦ · 26/02/2014 · customer operations...

Documents