Conference Program
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Day 1 - Tuesday, May 25, 2021

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

May 25, 2021 9:00am – 12:00pm

Speakers

Mark Myers_Headshot

Mark Myers
Director, Healthcare Resources Division
VA Office of Inspector General, Office of Contract Review (Washington, D.C.)

Melodee Snoke-Bullock_Headshot

Melodee Snoke-Bullock
Audit Manager, Public Law Compliance Group
VA Office of Inspector General (Washington, D.C.)

1:00
Co-Chairs’ Opening Remarks
1:15
Transitioning to a New Administration: A New Look at FSS Contracting and the Big Four
2:00

Case study

Success Stories: Developing Successful Strategies for Negotiating FSS Contracts for Pharmaceuticals
3:00
1:1 Networking
3:10
Refreshment Break
3:30
What Every Pharmaceutical Manufacturer Needs to Know About the VA OIG Pre-Award Review Process
4:15
A Guide to Non-FAMP and FCP Pricing Calculations and Mishap Corrections: Addressing Common Pricing Challenges Under Section 603 of the Veteran’s Health Care Act
5:15
Conference Adjourns to Day 2

Day 2 - Wednesday, May 26, 2021

9:00
Co-Chairs’ Opening Remarks and Recap
9:10
Trends in Domestic Sourcing for Pharmaceuticals and Related Requirements: Analyzing How Buy American and Country of Origin Challenges are Impacting Big Four Contracting
10:10
Unlocking The Secrets of Successful Contracting Longevity: Developing Strategies for Extended Product FSS Placement and Post Award Compliance
11:10
The TRICARE Program: How to Secure Successful Formulary Placement for Your Pharmaceutical Product
11:55
1:1 Networking
12:10
Lunch Break
12:55
340B Part 1: Properly Calculating Discounted Rates for Participants of the PHS 340B Program
1:45
340B Part 2: An Analysis of the Stakeholders and the Stakes: Dissecting the Discord Between the Federal Government, Covered Entities and Manufacturers
2:30
Refreshment Break
2:45
Single Pricing or Dual Pricing? Ensuring Optimal Results by Selecting the Proper Pricing Methodology
3:45
Preparing for A “Big Four” Agency Audit: Establishing Protocols and Best Practices for Proper Record Retention and Avoiding Costly Penalties
4:45
Closing Remarks, Conference Concludes

Day 1 - Tuesday, May 25, 2021

1:00
Co-Chairs’ Opening Remarks
Lorraine Campos_Headshot

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

Merle Delancey_Headshot

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

1:15
Transitioning to a New Administration: A New Look at FSS Contracting and the Big Four
James Kim_Headshot

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

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

This session will offer insights on pricing challenges that pharmaceutical manufacturers face when working through the Federal Supply Schedule (FSS) process, and what changes they anticipate under the Biden administration.

2:00

Case study

Success Stories: Developing Successful Strategies for Negotiating FSS Contracts for Pharmaceuticals

Erica Petersohn
Sr. Mgr., GP & Contracting Solutions Leader
Baker Tilly US, LLP (Raleigh, NC)

Kristen Knapp
Counsel
Sidley Austin LLP (Washington DC)

Utilizing a case study on a mock product, speakers will guide attendees through best practices for navigating 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 submitting a contract proposal
  • Completing CSP disclosures
  • Negotiating a customer or category of customers of comparability
  • Establishing compliance policies and procedures

3:00
1:1 Networking
3:10
Refreshment Break
3:30
What Every Pharmaceutical Manufacturer Needs to Know About the VA OIG Pre-Award Review Process

Michael Grivnovics
Director, FSS Contracts
VA Office of Inspector General (Washington, D.C.)

Rick Moore
Managing Partner
Federal Compliance Solutions LLC (Philadelphia, PA)

  • Examining the purpose of the VA OIG Pre-Award program
  • Analyzing key government regulations and policies related to the program
  • Exploring the concept of achieving fair and reasonable prices while working with government vendors
  • Addressing Pre-Award Review when reseller/ distributer involved
  • Developing best practices for participation in the VA OIG Pre-Award program
  • Anticipating potential actions taken by the VA when awarding a Rx Pharmaceutical government contract
  • Assessing the agency’s cost savings associated with the pre-award program

4:15
A Guide to Non-FAMP and FCP Pricing Calculations and Mishap Corrections: Addressing Common Pricing Challenges Under Section 603 of the Veteran’s Health Care Act
Melodee Snoke-Bullock_Headshot

Melodee Snoke-Bullock
Audit Manager, Public Law Compliance Group
VA Office of Inspector General (Washington, D.C.)

Joy Sturm_Headshot

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

Michele Zarychta
Sr. Corporate Counsel
Pfizer Inc. (Collegeville, PA)

  • Examining the role 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
  • Identifying the sources of data necessary to calculate the non-FAMP
  • Analyzing how the FCP and Non-FAMP affect one another
  • Assessing additional discount adjustments based on calculations
  • When must these calculations be reported to Veterans Affairs?
  • Assessing the role of the price reduction clause
  • Exploring the abnormalities seen when calculating the non-FAMP, and their causes
  • 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
  • Securing sub-ceiling and non-ceiling sales related to the 340B program

5:15
Conference Adjourns to Day 2

Day 2 - Wednesday, May 26, 2021

9:00
Co-Chairs’ Opening Remarks and Recap
Lorraine Campos_Headshot

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

Merle Delancey_Headshot

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

9:10
Trends in Domestic Sourcing for Pharmaceuticals and Related Requirements: Analyzing How Buy American and Country of Origin Challenges are Impacting Big Four Contracting

Elizabeth Lindquist
Partner
King & Spalding LLP (Denver, CO)

Stephen Ruscus_Headshot

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

This panel will explore key contracting considerations surrounding current and prior Administration Buy American initiatives, Country of Origin issues, Executive Orders, the Defense Production Act, etc.

  • Determining proper FSS contracting provisions that are relevant to the TAA
  • Understanding the current state of the law on TAA compliance
  • Developing best practices when contracting for products manufactured in non-TAA designated countries
  • Minimizing the risk of non-TAA compliance when self-certifying
  • Understanding the intended impacts of Trump and Biden Executive Orders government purchases of pharmaceuticals during and outside the pandemic
  • Examining the impact of the DPA on purchases of pharmaceuticals and investment in the US pharmaceutical industrial base

10:10
Unlocking The Secrets of Successful Contracting Longevity: Developing Strategies for Extended Product FSS Placement and Post Award Compliance
Merle Delancey_Headshot

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

Michael Grivnovics
Director, FSS Contracts
VA Office of Inspector General (Washington, D.C.)

Once a pharmaceutical product is placed on Federal Supply Schedule, only part of the work is done. With options, renewals, contract expiration dates, and future bidding, it is imperative to develop strategies to keep your products 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 at a higher price than it is listed at on the FSS
  • Putting strategies in place to encourage purchases directly from the manufacturer
  • Sales to/through Prime Vendors
  • Examining how the FSS price is connected to discount benchmarks
  • Determining how both FSS schedules and FSS national contracts impact the pricing of a product
  • Analyzing the requirements when working with MFC pricing and the criteria associated with it
  • Negotiating Customer(s) of Comparability for the Price Reductions-Clause to expand the opportunities of a product when working with FSS customers
    • What initiates a price reduction?
    • 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 policies are upheld to avoid overcharges and any associated penalties
  • Addressing payment overcharge requests stemming from purchases at open market prices
  • Conditions for modifying product pricing
  • Ensuring compliance with reporting requirements

11:10
The TRICARE Program: How to Secure Successful Formulary Placement for Your Pharmaceutical Product

Cheryl Nagowski
Vice President, Federal Markets
D2 Consulting, LLC

  • 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

11:55
1:1 Networking
12:10
Lunch Break
12:55
340B Part 1: Properly Calculating Discounted Rates for Participants of the PHS 340B Program

Margaux Hall
Partner
Ropes & Gray LLP (Washington, DC)

Jesse Mendelsohn
Vice President
Model N (Chicago, IL)

  • Understanding how the 340B program works with Medicaid, FSS, and TRICARE
  • Determining covered entities under the 340B program
  • Reviewing contract pharmacies and providing an overview of the current disputes
  • Reviewing the 340B-related revenue of 340B covered entities
  • Examining Medicaid pricing arrangements at 340B facilities and duplicate discounts
  • 340B dispute resolution processes:
    • The Alternative Dispute Resolution final rule
    • Strategies for dispute resolution
  • Identifying 340B facilities who have purchased products at incorrect prices
  • Devising methods to calculate refunds owed to purchasing institutions
  • Developing audit records to review vendor accounts
  • Working with pharmaceutical vendors to retrieve sales data to rectify overcharges

1:45
340B Part 2: An Analysis of the Stakeholders and the Stakes: Dissecting the Discord Between the Federal Government, Covered Entities and Manufacturers

Helen Pfister
Partner
Manatt, Phelps & Phillips, LLP (New York, NY)

This session will address concerns regarding adequate federal oversight to monitor the 340B program, pending lawsuits, and the implications for the future of the 340b contract pharmacy program, and will include:

  • Review of manufacturer restrictions on the distribution of 340B drugs to contract pharmacies
  • Discussion of the December 2020 HHS advisory opinion on contract pharmacy arrangements
  • Status of the 340B administrative dispute resolution process
  • Covered entity and manufacturer litigation
  • Reactions from federal/state officials
  • What the future holds

2:30
Refreshment Break
2:45
Single Pricing or Dual Pricing? Ensuring Optimal Results by Selecting the Proper Pricing Methodology
Melodee Snoke-Bullock_Headshot

Melodee Snoke-Bullock
Audit Manager, Public Law Compliance Group
VA Office of Inspector General (Washington, D.C.)

Plitsch Jennifer_Headshot

Jennifer L. Plitsch
Partner
Covington & Burling LLP
(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
  • Utilizing the proper pricing methodology to ensure the correct model is being implemented
  • Determining the FCP’s effect on the expansion of the duel 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

3:45
Preparing for A “Big Four” Agency Audit: Establishing Protocols and Best Practices for Proper Record Retention and Avoiding Costly Penalties
Melodee Snoke-Bullock_Headshot

Melodee Snoke-Bullock
Audit Manager, Public Law Compliance Group
VA Office of Inspector General (Washington, D.C.)

Annamarie Lee
Director, Advisory Services
IntegriChain (Philadelphia, PA)

  • Examining the audit process in relation to FSS contracting
    • What does the VA OIG look for during the audit process?
    • Scope of the audit – FCP applicable to VA and DoD
  • 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 noncompliance
    • Monetary penalties
    • Termination of the Master Agreement or PPA
    • Prohibitions from entering into new agreements
  • Enacting the proper steps for appealing decisions

4:45
Closing Remarks, Conference Concludes

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

May 25, 2021 9:00am – 12:00pm

Mark Myers_Headshot

Mark Myers
Director, Healthcare Resources Division
VA Office of Inspector General, Office of Contract Review (Washington, D.C.)

Melodee Snoke-Bullock_Headshot

Melodee Snoke-Bullock
Audit Manager, Public Law Compliance Group
VA Office of Inspector General (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 Regulations (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
  • 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
  • Entering into the Master Agreement (MA) and a Pharmaceutical Pricing Agreement (PPA)
  • The relationship of OBRA to Medicaid rebate
  • Introduction to the non-FAMP and FCP calculations
  • Examining terms that fall under VA and PHS discount programs
  • 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)
  • Understanding the PHS 340B program within the context of VHCA 601
  • Overview of VA and DoD PPV Programs