Main Conference Day 1: Tuesday, May 17, 2011
7:15 Registration & Continental Breakfast
8:15 Co-Chairs’ Opening Remarks
Cynthia Bass
Associate General Counsel, sanofi-aventis (Bridgewater, NJ)
Constance A. Wilkinson
Member of the Firm Epstein Becker & Green, P.C. (Washington, DC)
8:30 Successfully Administering FSS Contracts for Optimal Results
Marci Anderson
Senior Auditor,
VA Office of Inspector General (Jacksonville, NC)
Maureen Regan
Counselor to the Inspector General
VA Office of Inspector General (Washington, DC)
Merle M. DeLancey
Partner,
Dickstein Shapiro LLP (Washington, DC)
- Defining the Other Government Agencies (OGA) price, the FSS price and the Federal Ceiling Price (FCP)
- Recognizing which agencies/entities are entitled to purchase at different prices
- how is the FSS price filtering down to different agencies and entities and how should manufactures deal with entities that are entitled to purchase off of the FSS schedule but don’t?
- Consolidated Mail Out Patient Pharmacy System (CMOPS)
- where does Indian Health Services fit in?
- where does the DoD fit in?
- addressing why some government facilities may be purchasing from the wholesaler at a price higher than the FSS price
- Differentiating between the FSS fee schedule and FSS national contracts
- Overview of FSS pricing, discount benchmarks, and requirements
- Establishing the Most Favored Commercial Customer (MFC) price (also known as the “tracking customer” or “basis of award customer”)
- price reporting requirements and obligations
- what is its qualifying criteria?
- Understanding the tracking customer ratio and the implications of disturbing the ratio
- Price reduction clause
- identifying the basis of award (BOA) or “tracking” customer
- disclosure requirements
- dealing with frequent changes to the tracking customer price
- events that trigger the price reduction clause
- events that do not trigger the price reduction clause
- filling out the price reduction form
- reporting requirements
- Developing best practices for monitoring tracking customers
- capturing the necessary discount information
- evaluating manual and automated solutions
- Price adjustment clause
- when is this clause invoked?
- who has the authority to invoke it?
- when is price information considered inaccurate?
- what is the result of non-compliance?
- potential False Claims Act liability
- government’s burden of proof
- Economic price adjustment clause
- Industrial funding fee
- Understanding the repercussions of failing to update public law prices and/or modifications into the VA system
- responding to requests for payment of overcharges by agencies who had to purchase at open market prices
- verifying sales and prices
- Making modifications
- modification request form
- product addition
- price changes
- deletions
- administrative changes
- Complying with reporting requirements
- best practices for reporting prices faster and/or more accurately
10:00 Morning Coffee Break
10:15 VHCA Section 603: Calculating the Non-FAMP and the Federal Ceiling Price (FCP)
Marci Anderson
Senior Auditor,
VA Office of Inspector General Office of Contract Review (Jacksonville, NC)
Cynthia Bass
Associate General Counsel, sanofi -aventis (Bridgewater, NJ)
John D. Shakow
Partner,
King & Spalding (Washington, DC)
- Defining FCP and its role in government pharmaceutical price discounts
- Mastering the formula for calculating FCP
- exploring the relationship between FCP and non-FAMP
- defining non-FAMP
- Calculating non-FAMP
- what sales are included and excluded from the non-FAMP calculation?
- defining and identifying “nominal prices”
- determining whether or not to include fees related to Inventory Management Agreements (IMAs)
- if IMAs are included, what can manufacturers include?
- Identifying the data sources needed to calculate non-FAMP
- organizing data sources to make public law updates less burdensome
- Developing business practices and policies that will allow you to pull the necessary data and obtain the correct calculations
- Best practices for making the VA process more streamlined
- Recognizing when the additional discount provision is triggered
- calculating the additional discount adjustment
- When are FCP and non-FAMP calculations done and reported to the VA?
- How will changes to Medicaid calculation methodologies change the non-FAMP calculation methodology, if at all?
- Examining the relationship between the price reduction clause and FCP
- Examining common anomalies seen in non-FAMP calculations
- what causes price anomalies to occur?
- Correcting anomalies in price calculations
- what to do with penny or negative prices
- “smoothing” prices
- if smoothing is employed, does the VA have to be notified, and if so, how?
- if smoothing cannot correct the anomaly, what other solutions are available to the manufacturer?
- Managing pricing calculations for transferred drugs
- Pricing for new drugs
11:30 Understanding the VA’s Structure
Michael Grivnovics
Director, Federal Supply Schedule Division
Office of Contract Review VA Office of Inspector General (Washington, DC)
David Rice
Director of Federal Contracting
Compliance Implementation Services (Media, PA)
- Mapping out an organizational chart of the VA offices and key contacts within each office
- Defining the roles and responsibilities of the different offices
- recognizing which departments handle different problems or questions
- Understanding how the contracting office and the PBM office work together
- what are their primary responsibilities?
- what is the data/workflow between the two departments?
- what are the differences and similarities in how the contracting and the PBM offices work?
- Finding information on the VA’s website
- locating older guidance that used to be available
- key links for fi nding critical information
- How can manufacturers find out about changes to reporting requirements or timelines?
- How does the VA want manufacturers to communicate with it?
- best practices the VA would like to see employed by manufacturers
- Efficiently communicate changes to the VA
12:15 Networking Luncheon
1:30 Effectively Managing the Solicitation Process and Working With the Contracting Office
W.R. (Bob) Satterfield
Assistant Director, Contracting Branch – Administration
Federal Supply Schedule Service (Hines, IL)
Gregory Madden
Senior Contract Specialist, Contracting Branch – Administration
Federal Supply Schedule Service (Hines, IL)
Constance A. Wilkinson
Member of the Firm Epstein Becker & Green, P.C. (Washington, DC)
- Understanding the terms of the solicitation and the obligations imposed by FAR regulations incorporated into the agreement
- a plain language guide to the FAR requirements
- Developing SOPs for dealing with the administrative requirements imposed by the FAR regulations
- ensuring that subcontractors and internal departments are complying with FAR obligations
- Identifying the correct forms that must be completed and completing them properly
- avoiding common mistakes
- recognizing what will get a form kicked back
- Pre-award pricing disclosures
- what are the expectations of contracting officers when they receive disclosures from manufacturers?
- what information should disclosures contain and what should that information look like?
- Negotiating who is a “comparable customer”
- Gathering the information the manufacturer will need to provide during the course of the solicitation process
- Determining when a contract needs to be modified what is expected when a modification is submitted?
- Developing a roadmap for VA FSS pharmaceutical contract negotiations
- who is responsible for the different functions?
- who do you contact if you have a question?
- how does the restructuring of the contracting office affect who manufacturers need to talk to when they have a question?
- how should manufacturers be communicating with the contracting office?
- How has the contracting offi ce evolved over the past year
- What best practices would the contracting office like to see manufacturers employ?
- What changes, if any, is the contracting office contemplating since the restructuring took place?
3:00 Afternoon Coffee Break
3:15 Determining Whether to Employ Single Pricing or Dual Pricing
Marci Anderson
Senior Auditor VA Office of Inspector General (Jacksonville, NC)
David Rice
Director of Federal Contracting
Compliance Implementation Services (Media, PA)
- Developing your case to determine whether or not to adopt a single or dual pricing model
- examining your current pricing structure and conducting a five-year forecast
- studying the facilities you currently work with to see which entities would be eligible for the lower price and which would receive the higher price
- Making the move from single pricing to dual pricing
- how is the calculation done?
- what paperwork is entailed?
- When during the year can a manufacturer move to a dual schedule?
- Which agencies are really eligible for which pricing?
- what does “other government agency” really mean when it comes to dual pricing?
- Understanding the differences from year to year how are prices calculated from the first year to the second year?
- Executing a dual pricing scheme
- managing two price lists
- managing membership
- ensure that the right entities are receiving the lower price
- where do you go to get confirmation that a facility is eligible?
- Utilizing dual pricing to maximize the rate at which FCP can grow
- Examining the benefi ts and detriments of each type of pricing
- Best Price implications what does dual pricing do to your overall prices? −price modeling examples of how single versus dual • will affect manufacturers
4:15 What is a Covered Drug?
Joy E. Sturm
Partner,
Hogan Lovells (Washington, DC)
Many issues have been raised by the defi nition of the term “covered drug” under the Veteran Health Care Act of 1992.This session will discuss the background and coverage of this statutory term and address the issues faced by the VA and pharmaceutical companies as of late.
4:45 Current Issues in Pricing
Marci Anderson
Senior Auditor VA Office of Inspector General (Jacksonville, NC)
Maureen Regan
Counselor to the Inspector General VA Office of Inspector General (Washington, DC)
In this session, the VA will discuss current issues/problems they are routinely encountering and how manufacturers should be proceeding in these areas. This session will also serve as a forum for attendees to present their questions and concerns to the VA on public law and pricing issues they fi nd unclear or problematic.
5:30 Conference Adjourns to Day 2
Main Conference Day 2:Wednesday, May 18, 2011
7:45 Continental Breakfast
8:30 Co-Chairs’ Remarks
8:45 Audit Rights, Record Retention and Penalties
Maureen Regan
Counselor to the Inspector General
VA Office of Inspector General (Washington, DC)
James W. Kim
Attorney
McDermott Will & Emery LLP (Washington, DC)
- Overview of audits, record retention and penalties for non-compliance under VHCA
- Retention obligations
- how long do you need to retain records and how is the time period calculated?
- Working with the Veterans Affairs Office of Inspector General (VAOIG)
- examining the VAOIG’s role in pre and post-award reviews of FSS offers and Public Law compliance reviews
- what is the VAOIG looking for when conducting audits?
- Preparing for pre- and post-award audits
- what documentation do you need to have in place as you are doing your solicitation
- developing a checklist of essential documentation gathering and organizing data
- what should you be directing people to do with the data?
- validating the source data and ensuring its accuracy
- Avoiding actions that can result in penalties
- refusing to supply information in response to a VA request
- knowingly providing false information
- Voluntary disclosures
- Conducting self-audits
- Penalties levied for non-compliance
- monetary penalties
- termination of the Master Agreement or PPA
- prohibitions from entering into new agreements
- Appealing decisions
9:45 Demystifying the National Formulary System for the VA and the DoD
Dan Remund
Director,
DoD Business Operations WSI PBG, LLC (Kalamazoo, MI)
- Overview of the National Formulary System relative to the “Big Four” agencies
- Understanding the VA and DoD formularies
- what are their similarities and differences?
- understanding the role of the PEC for the DoD and three different types of formularies a product can be placed on
- How are products selected for the VA and DoD formularies?
- Strategies for securing formulary placement for new products
- interacting with key opinion leaders and P&T committees
- developing a pricing strategy to support that will support your formulary strategy
- Dealing with a formulary exclusion decision
- what are manufacturers’ options?
- Promoting a product as a non-formulary product
10:45 Morning Coffee Break
11:00 Securing National Contracts and Blanket Purchase Agreements
- What is required to establish a national contract?
- how do government facilities evaluate bids?
- Understanding the national contract/BPA process for the VA and for the DoD
- mapping out the timelines and identifying who you need to work with
- coordinating discounts with VA PBM and DoD PBM pharmacy objectives
- Using the NAC to negotiate a national contract/BPA versus negotiating with individual facilities
- evaluating the advantages and disadvantages of each approach
- Negotiating a national contract
- different ways to establishing market share and to define the market basket
- Preparing an application for a BPA Preparing a quote for a bid
- Joint national contracts between the VA and DoD
- Protesting a national bid
- Understanding how national contracts and BPAs affect other prices
12:00 Networking Luncheon
1:15 TRICARE: A Study in the DoD’s Managed Health Care Benefits Program
Lisa C. McNair
Senior Manager of TRICARE
Contracting Compliance Implementation Services (Media, PA)
- TRICARE program: scope and eligibility
- Establishment of the uniform formulary for TRICARE
- Considerations used when determining if a drug will be listed on the TRICARE formulary
- effect of being listed on the formulary on price
- Determining when manufacturers are required to negotiate agreements with TRICARE
- Update on the final rule and manufacturers’ waiver requests for retroactive rebates
- what does DoD need in order to provide manufacturers’ with a response to waiver requests?
- how long does DoD anticipate that manufacturers will have to wait for a determination on waiver requests
- Applying TRICARE utilization to pricing calculations for different price types – non-FAMP, FCP, AMP, and BP
- ensuring that all of the different pricing groups get the utilization they need and the way in which they need it
- addressing the challenges of accounting for TRICARE sales in your pricing calculations when manufacturers do not learn about TRICARE sales until after they have already taken place
- accounting for price fluctuations that may occur during the lag time between time of sale and receipt of utilization data
2:15 Afternoon Coffee Break
2:30 Managing the Implementation and Operational Challenges Resulting from Signifi cant Changes to the 340B Program
Lieutenant Commander Devin Williams (Invited)
Project Officer
Office of Pharmacy Affairs, HRSA (Rockville, MD)
Christopher A. Hatwig, M.S., R.Ph., FASHP
Vice President
Apexus/340B Prime Vendor Program (Irving, TX)
Benjamin S. Martin
Member of the Firm, Epstein Becker & Green, P.C. (Washington, DC)
- Purpose and function of the 340B program
- Identifying 340B “covered entities” and “new” covered entities created under PPACA
- how are new covered entities being added to the HRSA website?
- Eligibility for new entities
- when do new entities become eligible for 340B pricing?
- are they eligible for retroactive rebates?
- what types of discounts do they qualify for?
- Validating the eligibility of purchasers best practices for monitoring HRSA data
- Distinguishing 340B sales from non-340B sales made to entities that fill both types of prescriptions
- what data sources can manufacturers look to when attempting to make these distinctions?
- Managing the accrual uncertainty created by the expansion of the 340B program
- Restrictions for participating covered entities
- the anti-diversion provision
- prohibition against duplicate discounts
- measures manufacturers may employ to ensure covered entities are complying with these restrictions
- Understanding 340B pricing
- calculating 340B prices and understanding their relationship to Medicaid Drug Rebate calculations
- estimating PHS prices for new drugs
- 340B pricing for multi-source drugs
- Treatment of 340B sales in other federal drug pricing calculations
- Medicaid Average Manufacturer Price (AMP) and Best Price (BP)
- Medicare Part B Average Sales Price (ASP)
- VHCA non-FAMP
- treatment of sub-ceiling prices
- Adjusting PHS prices if and when prices are restated for Medicaid rebate purposes
- how far back do retroactive corrections have to go?
- overcoming the operational challenges of reconciling prices to thousands of PHS entities on a frequent basis
- providing PHS entities with reimbursement
- processing payments for PHS entities that are no longer covered entities
- Understanding how the new URA cap at 100% of AMP can still result in penny pricing and making system adjustments to capture this type of penny price
- Recalculating the PHS price for “line extension” products
- can the new AMP methodology be used when returning to the original baseline AMP or should the old methodology be used?
- What obligations do manufacturers have to ensure that PHS pricing is available to covered entities?
- Preventing double dipping by entities that participate in both 340B and GPO contracts
- Update on the proposed rule for auditing processes and dispute resolution
- what were some of the themes from the manufacturers’ comments?
- what does HRSA envision instituting the changes set forth in the proposed rule?
3:45 Leveraging Federal Contracts for Better Business
Terry Hunter
Federal Markets Consultant
Teva Pharmaceuticals and AMSUS – SM Board Member (Overland Park, KS)
Because federal pricing is substantially lower than prices offered to commercial customers and so much time and money is spent on administering federal contracts, manufacturers can often lose sight of why and how participation in federal programs can benefi t business. This session will examine how manufacturers can make the most of their participation in federal programs and how to ensure that federal pricing is helping not hindering other business objectives.
4:45 Conference Concludes
Conference Details