Day 1 - Monday, April 28, 2014

1:00
Pre-Conference Workshop

Day 2 - Tuesday, April 29, 2014

7:30
Registration and Continental Breakfast
8:30
Chair’s Opening Remarks
8:45
Part 1 – Overview of Medicaid Rebate: The Basic Building Blocks
10:00
Morning Coffee Break
10:15
Part 2 – Medicaid Rebate Challenges: Delving Deeper into the Knotty Issues
11:30
Developing Drug Pricing Strategies in an Evolving Federal Policy Environment: Health Care Reform and Beyond
12:30
Networking Luncheon
1:45
State Medicaid Programs and Their Relationship to the Federal Rebate System
2:45
Medicare Part B Drug Pricing
3:45
Afternoon Coffee Break
4:00
AWP (Average Wholesale Price) and Industry’s Search for a Viable Replacement Pricing Benchmark
4:30
Pricing Under the Public Health Service 340B Program
5:30
Conference Adjourns to Day 2

Day 3 - Wednesday, April 30, 2014

8:00
Registration and Continental Breakfast
8:50
Opening Remarks from Conference Chair
9:00
Medicare Part D: Fundamentals, Updates, and Operationalizing the Coverage Gap Discount Program
10:00
Understanding Opportunities and Pitfalls When Contracting with ACA Exchange Qualifi ed Health Plans
11:00
Morning Coffee Break
11:15
Managing the Operational Challenges of Government Prices: How to Get From Policy to Practice
12:15
Networking Luncheon
1:30
Understanding Reimbursement Changes and Enforcement Initiatives Relevant to Generic Drugs
2:30
Networking Coffee Break
2:45
Understanding the False Claims Act (FCA) and Ongoing Government Enforcement and Compliance Efforts

Day 4 - Thursday, May 1, 2014

9:00
Post-Conference Workshop

Day 1 - Monday, April 28, 2014

1:00
Pre-Conference Workshop

Government Payor Pricing 101: Primer for Professionals New to Pharmaceutical Pricing

William A. Sarraille
Partner
Sidley Austin LLP

John D. Shakow
Partner
King & Spalding LLP

This workshop will provide you with a basic overview of pharmaceutical pricing and government payor programs. This pre-conference workshop serves as a primer on the fundamentals of government pricing and will prepare you for the more in-depth discussions that will take place throughout the conference.

• Tracing the history of applicable legislation such as the MMA, DRA, and PPACA
• Tracing the flow of payments and reimbursements in the health care supply chain
– Identifying stakeholders within the chain and their roles
– Tracking the fl ow of drugs, payments and services
• Deciphering commonly used acronyms and terminology
• Overview of different pricing benchmarks and calculations
– AMP, AWP, ASP, WAC, BP, PHS, FCP, and non-FAMP
• Understanding the implications of different pricing methodologies, calculations and benchmarks for different stakeholders
• Examining the key pricing concepts and calculations for government drug pricing and rebate programs
– Medicaid Drug Rebate program
– Medicare Part B
– 340B Drug Pricing program
– Federal Supply Schedule/Federal Ceiling Price
– Medicare Part D
– TRICARE
• Identifying similarities and differences among the programs
• Considering the interactions among the programs
• Overview and analysis of the National Rebate Agreement: its origins and significance
• Review of the agreement’s terms and requirements for participation
• Understanding why participation in the Medicaid outpatient drug program is contingent on participation in the PHS 340B and VA programs
– How is the PHS program linked to Medicaid?
• Analyzing the relationship of the National Rebate Agreement to the Medicare Drug benefit? (i.e., Medicare Part D)
• Identifying the changes resulting from the enactment of the Patient Protection and Affordable Care Act (PPACA) and the Health Care and Education Affordability Reconciliation Act

​1:00 p.m. – 4:00 p.m. (Registration begins at 12:30 p.m.)

Day 2 - Tuesday, April 29, 2014

7:30
Registration and Continental Breakfast
8:30
Chair’s Opening Remarks

Larri A. Short
Partner
Arent Fox LLP (Washington, DC)

8:45
Part 1 – Overview of Medicaid Rebate: The Basic Building Blocks

John D. Shakow
Partner
King & Spalding LLP

Kathleen A. Peterson
Member
Cooley LLP

• Understanding the rebate formulas and the Unit Rebate Amount (URA) calculation

• Average Manufacturer Price (AMP): what is it and how is it calculated?
– What is included and excluded from the calculation?
• What is Best Price and how is it calculated?
– What is included and excluded?
– Branded and generic product examples
• Key definitions applicable to both AMP and Best Price
– Bona fide service fees; bundled sales
– Customary prompt pay discounts
• Making class of trade classifi cations and why they are important
• Lagged and non-lagged concessions
• Smoothing; Bundling
• Bona fide services fees and administrative fees
• Rebate segment mechanics
• Base data AMP and the infl ation penalty
• What do invoices look like?
– ROSI and PQAS; how to validate the rebate

10:00
Morning Coffee Break
10:15
Part 2 – Medicaid Rebate Challenges: Delving Deeper into the Knotty Issues

William A. Sarraille
Partner
Sidley Austin LLP

T. Reed Stephens
Partner
McDermott Will & Emery LLP

• How does the new AMP definition affect AMP calculations?

– Calculating AMP for products that are not sold to community retail pharmacies
• The 5(i) alternative calculation
• Rebates to managed care organizations
• Issues around the “default” rule
• Authorized generics
• Problems in bona fi de service fees: reconciling the different definitions
• How are manufacturers addressing the change in the AMP definition?
• Medicaid reimbursement provisions in health care reform
• Public availability of AMP
• Implications of the 100% cap on the URA for 340B prices
• Pricing of line extension products
• Systems confi guration and maintenance in light of health care reform

11:30
Developing Drug Pricing Strategies in an Evolving Federal Policy Environment: Health Care Reform and Beyond

Steven K. Stranne MD, JD
Shareholder
Polsinelli Shughart PC

• The potential impacts of federal policy developments

• The possibility of changes to the average sales price (ASP) methodology
• The relevant provisions and ongoing implementation of the Affordable Care Act
• Potential impacts of innovative delivery models, including but not limited to accountable care organizations
• Comparative effectiveness research
• Issues arising from federal efforts to address drug shortages
• Considerations related to the policy debates over the sustainable growth rate (SGR) formula and other relevant issues

12:30
Networking Luncheon
1:45
State Medicaid Programs and Their Relationship to the Federal Rebate System

Paula Martins
Director, Government Contracts
Daiichi Sankyo, Inc.

• Understanding how state Medicaid programs operate

– Identifying the unique features and key differences of the various state programs
– Understanding how drugs in various states are actually reimbursed
• Complying with state reporting requirements
– What states have reporting requirements?
– What are the reporting requirements?
– How will changes to the AMP definition impact manufacturers’ reporting requirements
• Getting a drug on formulary
– What are Preferred Drug Lists (PDLs) and what criteria are evaluated before a drug is placed on a PDL?
• State Pharmaceutical Assistance Programs(SPAPs)
• Supplemental Drug Rebate Agreements
• What impact could the calculation of new URAs have on SPAPs and Supplemental Agreements?
• Understanding how Medicaid Managed Care programs operate
– Who are these entities?
– How are the formularies run?
 How much control do the plan sponsors have over the formulary versus the state?
• Inclusion of Medicaid Managed Care programs in the federal rebate program
– Assessing the impact this will have on negotiated discounts/rebates between plan sponsors and manufacturers
 Preparing for the possibility of double discounts
– recognizing which Medicaid managed care plans are covered under the federal statute requirements and which are not
– How will inclusion in the federal rebate program affect formularies and PDLs?
– What impact will the inclusion in the federal rebate program have on manufacturers’ rebate strategies?
• Accruing for rebates in light of changes to Managed Medicaid
• How are states planning to implement the requirements mandated by the federal government?
– Where will the money for implementation come from?
• The issues in Texas: where do they stand?

2:45
Medicare Part B Drug Pricing

Judith A. Waltz
Partner
Foley & Lardner LLP

• Understanding Part B pricing methodologies, coverage and coding

– Average Sales Price (ASP)
– Recognizing the differences in coverage, pricing and coding among various outpatient settings
• Calculation of ASP
– Inclusions and exclusions
– Exempt and non-exempt sales
– Smoothing
– The three quarter lag
– Bona fide service fees
– Free goods
– Patient assistance
– Coupons
• Submission of ASP data: timing
– OIG and state AG efforts to obtain data
– How will late filed ASPs be dealt with when calculations are done?
 How will the data gaps be filled?
• CMS’s proposed treatment of “intentional overfill”
– How will ASP be calculated for “overfi lled” products?
• Bundling
• Special issues for radio-pharmaceuticals
• Reimbursement of biosimilars under Part B
– Managing new coding protocols and a hybrid payment model
• Preparing for the trend toward ACOs and new payment models that may be evolving.
– Policy issues
– Medicare proposed models that emphasize cost saving, e.g., accountable care
– Outcomes – passed rebates
• WAMP, AMP, LCA, and other possible risks in light of the deficit reduction efforts

3:45
Afternoon Coffee Break
4:00
AWP (Average Wholesale Price) and Industry’s Search for a Viable Replacement Pricing Benchmark

William A. Davis
Member
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.

• How to minimize risk under current system and evolving potential future system

– Where are we in this process?
– When will it be over?
• When and why is AWP still used for reimbursement?
• Understanding what constitutes WAC and how it is used
– Other terms manufacturers substitute for WAC
• Setting AWP and WAC
– The role of 3rd party pricing compendia with respect to AWP and WAC
• Examining the effect of AWP litigation on the continued use of this pricing methodology
– Lessons learned from the AWP cases before Judge Saris
 Should we be modifying behavior?
– Update on state AWP cases
• Assessing the impact of health care reform on different pricing benchmarks (AMP, AWP, and WAC)
• What replacement metric should take the place of AWP and what the challenges are associated with those metrics?
• Pharmacy acquisition costs

4:30
Pricing Under the Public Health Service 340B Program

William H. von Oehsen III
Principal
Powers Pyles Sutter & Verville PC (Washington, DC)

Joseph W. Metro
Partner
Reed Smith LLP

• Responding to a new era of oversight and enforcement: recertification of all 340B entities

– What is the latest with these audits?
– Are they uncovering diversion?
– What are HRSA’s findings?
– What are the outcomes of audits by the manufacturers?
– What are the implications of those findings for the future of the program?
• Evaluating the forthcoming rule
– Emerging issues
– Dispute resolution
• Identifying 340B “covered entities” and “new” covered entities created under PPACA
– How are new covered entities being added?
• Orphan drug exclusions for new covered entities
• Understanding the patient rule under 340B
• Truing up 340B prices if and when prices are restated for Medicaid rebate purposes
• Restrictions for participating covered entities
– The anti-diversion provision
– Prohibition against duplicate discounts
– How can manufacturers ensure covered entities are complying with these restrictions?
• Sub-PHS pricing
– How does maintaining low PHS prices affect non-FAMP and FCP pricing calculations
– Pros and cons of sub-ceiling pricing
• Using allocation programs to ensure equitable and appropriate distribution of products
• Estimating your PHS price for new drugs
• Prime vendor program
• Rebate arrangements with AIDS Drug Assistance Programs and compliance with 340B price controls
• Navigating the process for the resolution of overcharge claims by covered entities and claims by manufacturers alleging duplicate discounting or the unauthorized resale or transfer of covered outpatient drugs
• Status of the GAO report on the 340B program
• Litigation update
• What effect will Tricare data from 2008 being pushed on manufacturers have on annual non-FAMP reporting

5:30
Conference Adjourns to Day 2

Day 3 - Wednesday, April 30, 2014

8:00
Registration and Continental Breakfast
8:50
Opening Remarks from Conference Chair
9:00
Medicare Part D: Fundamentals, Updates, and Operationalizing the Coverage Gap Discount Program

Melissa K. Bianchi
Partner
Hogan Lovells US LLP

• ​Understanding the mechanics of how Part D is run

– What subsidies and payments do Part D plans receive?
– Interaction with 28% Retiree Drug Subsidy and commercial rebates
• Reporting of Part D rebates and PBM administrative fees
• Part D fraud & abuse issues
• Identifying critical dates for Part D participation
• Rebate contracting strategies under Part D
• Assessing new opportunities and pitfalls from the closing of the Coverage Gap over time
• Preparing for potential new mandates imposed by the Independent Payment Advisory Board
• Taking advantage of revolutionary changes from plan star ratings
• Potential legislative changes to require Medicaid-level rebates in Part D
• Overview of PPACA legislation and CMS program design
• Validating TPA CGDP invoice amounts
• Managing the logistics of payments to multiple plan sponsors
• CGDP payment disputes
• Conduct of CGDP audits
• Restrictions on use of CGDP data
• What are manufacturers’ appeal rights?
• Interaction with “Outside of Medicare” Part D patient assistance programs
• Quarter-by-quarter analysis of managing accruals for the coverage gap
– Surprises
– Lessons learned

10:00
Understanding Opportunities and Pitfalls When Contracting with ACA Exchange Qualifi ed Health Plans

Robert J. Hill
Partner
Reed Smith LLP

• Exchange Qualifi ed Health Plan (QHP) Fundamentals

– Essential Health Benefi t formulary requirements
– QHP Premiums and Premium Tax Credits
– Cost-Sharing Subsidies, Risk Adjustment, Reinsurance and Risk Corridors
• QHP Marketplace and Enrollment
– Real-world example of plan comparison and enrollment
– Who is enrolling? In what plans?
• Fraud and Abuse Issues
– Are QHPs subject to the Anti-Kickback Statute? False Claims Act?
 Sebelius letter and subsequent developments
– Implications for Manufacturer/Provider Coupons, Copay Assistance, Premium Assistance
• Rebate Contracting for QHPs
– Tailoring Rebate Terms/Conditions for QHPs
– Legal Reporting/Disclosure issues; PBM Administrative Fees
– Utilization Data requirements
• Technical/Implementation Issues – 2014 and beyond
– “Back-end” systems; SHOPs
– Enrollment fraud?
– Latest developments

11:00
Morning Coffee Break
11:15
Managing the Operational Challenges of Government Prices: How to Get From Policy to Practice

​Operational Challenges

• Sources of data for calculation of federal price values
– How is data smoothed for AMP?
– Earned date or paid date?
– Is class of trade assignment an issue?
– Adjustments to sales
• Operational challenges presented by health care reform implementation
– Systems configuration and maintenance in light of health care reform
 Accommodating the changes that will be necessary under health care reform
– What will it cost companies to implement these system changes?
• Data handling in federal price calculations
– What is the structure of the calculation?
– How is data validated?
– What are the differences between AMP, non-FAMP, and ASP?
– What will the OIG want to see?
• Delivery of federal price values
– What is up front and what is delivered on the back end?
– Is an SPAP important?
– Supplementals: why are they here?
• What IT solutions exist for managing the enormous sets of data used in pricing?
• How can companies who have merged marry two different pricing systems, if at all?

Finance related challenges
• Understanding the background and purpose for SOX
• Defining key terminology
• Making adjustments to gross and net revenue for Medicaid & Medicare rebates in light of health care reform
• Developing effective internal controls (IC) and documentation of methodology to ensure SOX compliance
• Have the systems used to process claims/calculate liability been updated & validated?
• What controls have been automated?

12:15
Networking Luncheon
1:30
Understanding Reimbursement Changes and Enforcement Initiatives Relevant to Generic Drugs

Larri A. Short
Partner
Arent Fox LLP (Washington, DC)

Susan Pilch
Vice President Policy and Regulatory Affairs
National Community Pharmacists Association

• Update of CMS Developments –NADACs, FULS, and State Requirements Regarding Changes to FFS Medicaid Reimbursement Algorithms

• Best practices to take away from new litigation over drug approval status and product drug set up in DDR
– Louisiana
– Other possible issues
• What do new pricing statics mean for the AWP risk?
– Will there be a continuing role for WAC and/or AWP?

2:30
Networking Coffee Break
2:45
Understanding the False Claims Act (FCA) and Ongoing Government Enforcement and Compliance Efforts

Kirsten Mayer
Partner
Ropes & Gray LLP (Boston, MA)

Heidi A. Sorensen
Of Counsel
Foley & Lardner LLP

Wendy C. Goldstein
Partner
Cooley LLP

​False Claims Act (FCA) Cases – A Year in Review

• Insulating yourself from FCA liability
• What to do when no formal rule is in place
• Drafting a letter to the agency
• Dealing with gray areas complicated by the fact that there is currently no guidance
– Bundling
– 5I
– Reconciling AMPs
• What should you be doing with the fact that you are within the period of restating AMPs after health care reform kicked in
• Minimizing exposure when making reasonable assumptions

The Enforcement Roles of OIG and Other Agencies
• Understanding the current environment for compliance and enforcement related to pricing issues
• Identifying compliance guidance for pricing issues
• Analyzing enforcement trends
• Anatomy of a government investigation
• Roles of CMS, OIG and DOJ
• Responding to government investigations
• Collateral consequences of investigations
• State enforcement issues

4:15 Conference Concludes 

Day 4 - Thursday, May 1, 2014

9:00
Post-Conference Workshop

Federal Government Contracts and Pricing: FSS, VA, DOD and More

Marci Anderson
Senior Auditor
VA Office of the Inspector General

Maureen Regan
Counselor to the Inspector General
VA Office of the Inspector General

• The Department of Veterans Affairs’ delegated authority to negotiate and administer GSA FSS pharmaceutical contracts

• Determining the FSS price
– Identifying the Most Favored Commercial Customer (MFC) price
– Price adjustment clause
– Price reduction clause
– Economic price adjustment clause
– Industrial funding fee
• Defining FCP and its role in government pharmaceutical price discounts
• Calculating non-FAMP (non-Federal Average Manufacturer Price)
– What sales are included and excluded from the non-FAMP calculation?
– Defining and identifying “nominal prices”
• Examining the relationship between the price reduction clause and FCP
• Dealing with pricing calculations for transferred drugs and new drugs
• VA and DoD formularies
– Getting products on VA & DoD formularies
– Working with Veterans Integrated Service Networks (VISN) formularies
– Recognizing the differences between the TRICARE formulary and VA and DoD formularies in a VA hospital setting
• VA audit rights, record retention policies and penalties

​9:00 a.m. – 1:00 p.m. (Registration begins at 8:30 a.m.)