Day 1

Virtual Workshop — “Big Four” 101: An Introduction to Key Agencies, Applicable Programs and Pricing Methodologies

May 2020

Speakers

Merle Delancey
Partner
Blank Rome LLP
(Washington, D.C.)

Mark Myers
Director, Healthcare Resources Division
VA Office of Inspector General, Office of Contract Review
(Jacksonville, NC)

Melodee Snoke-Bullock
Senior Auditor
Office of Inspector General/Contract Review, Department of Veterans Affairs (Washington, D.C.)

11:00
Break
12:00
Co-Chairs’ Opening Remarks
12:15
Town Hall Forum with Veterans Affairs on FSS Contracting
1:00
Implementing Successful Strategies to Obtain FSS Contracts for Pharmaceutical Products
2:00
Break
3:00
Industry Keynote Address: Examining the Evolution of Contracting with the Big Four
3:30
Exploring the VA Pre-Award Review Process
4:00
Working Group on the Submitting Successful Contract Bids Under the Prime Vendor and Pharmaceutical Standardization Programs
4:45
End of Day

Day 2

9:00
Co-Chairs’ Opening Remarks
9:15
The Acetris Appeal – A Question of Interpretation:
Understanding How Country of Origin Designation Under the Trade Agreements Act (TAA) May Impact Big Four Contracting
9:45
Developing Effective Methods for Extended Product Placement on the FSS
10:45
Break
11:45
Troubleshooting FAMP, Non-FAMP and FCP Pricing
Calculations Mishaps: Addressing Common Pricing Challenges Under Section 603 of the Veteran’s Health Care Act
12:45
340B Discounts: Properly Calculating Discounted Rates for Participants of the PHS 340B
1:15
Differentiating Between Single and Duel Pricing Methodologies:
Determining Which of the Two Will Provide Best Results
2:15
Break
3:15
The TRICARE Program:
Implementing Strategies to Secure Successful Formulary Placement
4:00
Preparing for a “Big Four” Agency Audit:
Ensuring Proper Record Retention and Avoiding Costly Penalties
5:00
End of Day

Day 1

11:00
Break
12:00
Co-Chairs’ Opening Remarks
Stephen Ruscus_Headshot

Stephen Ruscus
Partner
Morgan Lewis & Bockius LLP (Washington, D.C.)

William Sarraille_Headshot

William Sarraille
Partner
Sidley Austin LLP
(Washington, D.C.)

12:15
Town Hall Forum with Veterans Affairs on FSS Contracting
Mark Myers_Headshot

Mark Myers
Director, Healthcare Resources Division
VA Office of Inspector General, Office of Contract Review
(Jacksonville, NC)

Melodee Snoke-Bullock_Headshot

Melodee Snoke-Bullock
Senior Auditor
Office of Inspector General/Contract Review, Department of Veterans Affairs (Washington, D.C.)

Veterans Affairs’ representatives will offer first hand insights and address audience questions regarding common pricing challenges faced by Rx pharmaceutical manufacturers when working through the Federal Supply Schedule (FSS) process.

1:00
Implementing Successful Strategies to Obtain FSS Contracts for Pharmaceutical Products
Michelle-L-Butler_Headshot

Michelle L. Butler
Director
Hyman, Phelps & McNamara, P.C. (Washington, D.C.)

Lorraine Campos_Headshot

Lorraine Campos
Partner
Crowell & Moring LLP
(Washington, D.C.)

Gregory Madden_Headshot

Greg Madden
Managing Member
Orlaithe Consulting LLC
(Aurora, IL)

Utilizing a case study on a mock product, speakers will guide attendees through best practices for maneuvering the FSS contracting process.

  • Addressing strategies for contract development and renewal, while meeting timelines during the bidding process
  • Implementing contracting fundamentals and meeting legal requirements when offering a contract proposal
  • Developing guidelines for securing and maintaining contracting information
  • Identifying essential elements of the proposal while keeping core legal requirements in mind

2:00
Break
3:00
Industry Keynote Address: Examining the Evolution of Contracting with the Big Four
Rodney Emerson_Headshot

Rodney Emerson
Executive Director, Pricing
Sandoz
(Princeton, NJ)

3:30
Exploring the VA Pre-Award Review Process
blank-headshot

Michael Grivnovics
Director, Federal Supply Schedule Division
VA Office of Inspector General (Washington, D.C.)

  • Examining the purpose of the VA Pre-Award program
  • Analyzing key government regulations and policies related to the program
  • Exploring the steps involved to achieve fair and reasonable prices while working with government vendors
  • Developing best practices for participation in the VA Pre-Award program
  • Defining an “informed decision” within the pre-award process
  • Anticipating potential actions taken by the VA when awarding a Rx Pharmaceutical government contract
  • Assessing the agency’s cost savings associated the pre-award program

4:00
Working Group on the Submitting Successful Contract Bids Under the Prime Vendor and Pharmaceutical Standardization Programs
Ted Karnezis_Headshot

Ted Karnezis
Manager
KPMG US
(Chicago, IL)

4:45
End of Day

Day 2

9:00
Co-Chairs’ Opening Remarks
9:15
The Acetris Appeal – A Question of Interpretation:
Understanding How Country of Origin Designation Under the Trade Agreements Act (TAA) May Impact Big Four Contracting
Stephen Ruscus_Headshot

Stephen Ruscus
Partner
Morgan Lewis & Bockius LLP (Washington, D.C.)

The question of U.S. product origin is essential to FSS contracting per the Federal Acquisition Regulation (FAR). In Acetris Health v. United States, the U.S. Court of Federal Claim held that pharmaceutical products manufactured in the U.S that were made with active product Ingredients (APIs) from nondesignated countries under the US Trade Agreements Act met the FAR U.S. product origin test. This decision is now under appeal at the Federal Circuit and if reversed, may have game changing implications for Big Four contracts.

  • Determining proper FSS contracting provisions that are relevant to the TAA
  • Understanding how a reversal of the Acetris decision by the Federal Circuit could be a game changer
  • Developing best practices when contracting for products manufactured in non-TAA designated countries during the Acetris appeal
  • Examining methods to calculate an FCP without a contract in place
  • Minimizing risk of non-TAA compliance when self-certifying

9:45
Developing Effective Methods for Extended Product Placement on the FSS
blank-headshot

Michael Grivnovics
Director, Federal Supply Schedule Division
VA Office of Inspector General (Washington, D.C.)

Once a pharmaceutical product has been placed on Federal Supply Schedule, only part of the work is done. With contract expiration dates and future bidding, it is imperative to develop strategies to keep your product on the FSS for the long haul.

  • Identifying the agencies entitled to make purchases off the FSS, and the pricing methodologies associated with each
    • Consolidated Mail Out Patient Pharmacy System (CMOPS)
    • Indian Health Services (IHS)
    • Department of Defense (DoD)
  • Assessing the reasons why government facilities may purchase a product from a PBM at a higher price than it is listed at on the FSS
  • Putting strategies into place which will encourage purchases directly from the manufacturer
  • Examining how the FSS price is connected to discount benchmarks
  • Determining how both FSS fees schedule and FSS nation contracts impact the pricing of a product
  • Analyzing the requirements when working with MCF pricing and the criteria associated with it
  • Implementing clauses in pricing reductions to expand the opportunities of a product when working with FSS customers
    • What initiates price reduction clauses
    • What disclosures are required when working with the Basis of Award
    • Methods to track changes to customer pricing requirements
  • Determining the outcomes of refusal to comply with price reduction clauses
  • Properly monitoring active buyers from government agencies
  • Ensuring public law pricing polices are adhered to avoid any associated penalties
  • Addressing payment overcharge requests stemming from purchases at open market prices
  • Insuring compliance when requesting to modify product pricing
  • Ensuring compliance with reporting requirements

10:45
Break
11:45
Troubleshooting FAMP, Non-FAMP and FCP Pricing
Calculations Mishaps: Addressing Common Pricing Challenges Under Section 603 of the Veteran’s Health Care Act
Mark Myers_Headshot

Mark Myers
Director, Healthcare Resources Division
VA Office of Inspector General, Office of Contract Review
(Jacksonville, NC)

Melodee Snoke-Bullock_Headshot

Melodee Snoke-Bullock
Senior Auditor
Office of Inspector General/Contract Review, Department of Veterans Affairs (Washington, D.C.)

Joy Sturm_Headshot

Joy Sturm
Partner
Hogan Lovells LLP
(Washington, D.C.)

  • Examining the role of the Federal Ceiling Price (FCP) plays in discounts related to pharmaceutical pricing discounts within the “Big Four” agencies
  • Implementing the correct formula for calculating the FCP
  • Determining the role of the Non-Federal Average Manufacturers Price (Non-FAMP) within the contracting process and ensuring the proper calculations
  • Exploring Inventory Management Agreements and their effects on calculations
  • Identifying the sources of data necessary to calculate the non-FAMP
  • Implementing strategies for the collection of data needed to ensure accurate calculations
  • Analyzing how the FCP and Non-FAMP effect one another
  • Assessing additional discount adjustments based on calculations
  • When must these calculations be reported to Veterans Affairs?
  • What are the ways in which changes to Medicaid calculations can affect non-FAMP calculations?
  • Assessing the role of the price reduction clause
  • Exploring the abnormalities seen when calculating the non-FAMP, and their causes
  • Preparing for irregularities when calculating prices
    • Penny pricing
    • “Smoothing” prices
    • Notifying the VA of these irregularities
  • Correctly calculating pricing while incorporating lagged price reductions
  • Developing pricing calculations when working with new and transferred pharmaceuticals
  • Maintaining compliance when communicating price reductions with wholesalers
  • Overcoming difficulties within the TRICARE Retail Pharmacy Benefit Plan (TRRx)
  • Securing sub-ceiling and non-ceiling sales related to the 340B program

12:45
340B Discounts: Properly Calculating Discounted Rates for Participants of the PHS 340B
William Sarraille_Headshot

William Sarraille
Partner
Sidley Austin LLP
(Washington, D.C.)

1:15
Differentiating Between Single and Duel Pricing Methodologies:
Determining Which of the Two Will Provide Best Results
Mark Myers_Headshot

Mark Myers
Director, Healthcare Resources Division
VA Office of Inspector General, Office of Contract Review
(Jacksonville, NC)

Plitsch Jennifer_Headshot

Jennifer L. Plitsch
Partner
Covington & Burling LLP
(Washington, D.C.)

Melodee Snoke-Bullock_Headshot

Melodee Snoke-Bullock
Senior Auditor
Office of Inspector General/Contract Review, Department of Veterans Affairs (Washington, D.C.)

  • Understanding the reasons for implementing a single or dual pricing model
  • Exploring the requirements for transitioning between the two models and the calculations associated with this transition
  • Determining which of the agencies are eligible for each pricing model
  • Analyzing the changes to agencies on a yearly that will affect each of these pricing model
    • What are the considerations given during the first year of the contract?
  • Utilizing the proper pricing methodology to ensure the correct model is being implemented
  • Determining the FCP’s effect on the expansion of the dual pricing model
  • Assessing the positives associated with each of the pricing strategies
    • Best Price implications
    • What are the effects of these models on overall pricing?
    • What are the effects of single pricing and dual pricing on manufacturers?
  • Comprehending how the FCP and the FSS affect one another
  • Correctly incorporating FSS pricing into the FCP to achieve positive results
  • Analyzing methods for price reduction

2:15
Break
3:15
The TRICARE Program:
Implementing Strategies to Secure Successful Formulary Placement
James Kim_Headshot

James Kim
Partner
McDermott, Will & Emery LLP (Washington, D.C.)

  • Assessing the requirements to appear on TRICARE’s formulary
  • Determining which drugs will be listed on the formulary for TRICARE
  • Exploring the negotiations which companies must partake in when attempting to reach the TRICARE formulary
  • Analyzing eligible retroactive rebates manufacturers may request
    • What are the DoD requirements when responding to a manufacturers’ waiver requests?
    • What is the waiting period for a waiver request?
  • Applying TRICARE utilization to pricing calculations for different price types – non-FAMP, FCP, AMP, and BP
    • Ensuring that the necessary calculations are being utilized for the different pricing groups
    • Reviewing the challenges of accounting for TRICARE sales in your pricing calculations
    • Accounting for price fluctuations that may occur during the period between time of sale and receipt of utilization data

4:00
Preparing for a “Big Four” Agency Audit:
Ensuring Proper Record Retention and Avoiding Costly Penalties
Mark Myers_Headshot

Mark Myers
Director, Healthcare Resources Division
VA Office of Inspector General, Office of Contract Review
(Jacksonville, NC)

Melodee Snoke-Bullock_Headshot

Melodee Snoke-Bullock
Senior Auditor
Office of Inspector General/Contract Review, Department of Veterans Affairs (Washington, D.C.)

  • Examining the audit process in relation to FSS contracting
    • What does the VA OIG look for during the audit process?
  • Determining a company’s obligations regarding record retention
  • Avoiding actions that can result in costly penalties
    • Refusing a VA request for information
    • Knowingly providing false information
  • Developing methods for preparing voluntary disclosures
  • Efficiently conducting self-audits to ensure compliance
  • Reviewing the penalties levied for non-compliance
    • Monetary penalties
    • Termination of the Master Agreement or PPA
    • Prohibitions from entering into new agreements
  • Enacting the proper steps for appealing decisions

5:00
End of Day

Virtual Workshop — “Big Four” 101: An Introduction to Key Agencies, Applicable Programs and Pricing Methodologies

May 2020

Merle Delancey
Partner
Blank Rome LLP
(Washington, D.C.)

Mark Myers
Director, Healthcare Resources Division
VA Office of Inspector General, Office of Contract Review
(Jacksonville, NC)

Melodee Snoke-Bullock
Senior Auditor
Office of Inspector General/Contract Review, Department of Veterans Affairs (Washington, D.C.)

What is it about?

This pre-conference workshop will introduce attendees to the laws, regulations, and pricing methodologies utilized by the “Big Four” agencies in formulary determinations and securing contracts. Speakers will provide an overview to prepare you for the more in-depth discussions that will take place throughout the conference.

  • Identifying the “Big Four” agencies: VA, DoD, PHS, and Coast Guard
  • The Federal Acquisition Regulation (FAR) and its relation to government procurement and “Big Four” contracting
  • Exploring the Department of Veterans Affairs’ delegated authority in relation to FSS pharmaceutical contracts
  • Determining the mechanics of FSS contracts and the schedules associated with it
  • Examining reporting requirements when contracting with the “Big Four”
    • Accurately completing the CSP sheets and the related disclosure requirements
  • Examining the treaties by which GSA/FSS contracts are bound
  • Identifying FSS eligible entities
  • Complying with FSS clauses regarding socioeconomic programs
  • Entering into the Master Agreement (MA) and a Pharmaceutical Pricing Agreement (PPA)
  • Introduction to the non-FAMP and FCP calculations
  • Exploring the Veterans Health Care Act of 1992
    • Introduction to Section 602 – pricing for Public Health Services Act (PHS) covered entities
    • Section 603 – authorization for the VA to negotiate drug prices
  • Examining terms which fall under each discount program
  • Analyzing the Federal Supply Schedule related to government contracting in the pharmaceutical space
  • Identifying key pricing terms related pricing within government pharmaceutical programs
    • Federal Ceiling Price (FCP)
    • Pharmacy benefits management programs (PBMs)
    • National formularies
    • VA National Formulary
    • DoD Uniform Formulary
  • Assessing the functions of the PHS 340B program and identifying qualified entities under the Affordable Care Act
    • Examining the discounts available under the 340B program
    • Determining methods to monitor HRSA data
    • Exploring the restrictions that exist for participating covered entities
  • The relationship of OBRA to Medicaid rebate