Agenda
Day 1
June 17, 2024
12:00 pm
Co-Chairs’ Welcome Remarks Big Four Year in Review: An In-Depth Analysis of Recent Critical Developments Impacting Rx Pharmaceutical Contracting with the Big Four Agencies
In this opening session, our esteemed co-chairs will set the stage for the conference with highlights of the latest developments impacting the Big Four. Join us for an in-depth discussion on the latest regulatory developments, agency advances, and litigation updates impacting drug pricing within the “Big Four” agencies.
12:30 pm
The Evolving FSS Contract Lifecycle: A Practical Guide to Successful Procurement and Retention of Big Four Contracts in 2024
With the use of hypotheticals, this session will examine how to successfully enter contract(s) to make sales to the Big Four, what happens once the contract has been awarded, and how to have your contract successfully renewed.
- Implementing contracting fundamentals and meeting legal requirements when offering a contract proposal
- Hypothetical using mock products
- Developing guidelines for securing and maintaining contracting information
- Identifying the agencies entitled to make purchases off the FSS, and the pricing methodologies associated with each
- Consolidated Mail Outpatient Pharmacy System (CMOPS)
- Indian Health Services (IHS)
- Department of Defense (DoD)
- Sales through Prime Vendor Programs
- 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 encourage purchases directly from the manufacturer
- Examining how the FSS price is connected to discount benchmarks
- 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
- Seeking Economic Price Adjustments
1:30 pm
It is crucial to maintain a well-versed understanding of how government drug contracts are made and how drug price negotiations occur. This session will provide an overview of government drug payor programs, including Big Four agencies. Points of discussion include:
- Understanding the procedural steps required for manufacturers to enter a drug contract through government drug payor programs:
- VA
- DoD
- PHS 340B
- Medicare
- Medicaid
- Distribution Agreements with Prime Vendors based on separately negotiated pricing with the VA (e.g., blanket purchase agreements (BPA)) and DOD (e.g., distribution and pricing agreements (DAPA))
- Outlining new drug price negotiations processes
- How do you calculate FCP?
- Assessing what every manufacturer needs to know when obtaining contracts for multiple drug payor programs
- If a drug is declined under one program, will this affect the success of it under another?
- Analyzing how Non-FAMP is used under the IRA’s drug pricing program
- Learn how to leverage Non-FAMP
- Use of Temporary Price Reductions (TPR) under TRICARE Retail Pharmacy Program (TRRx)
2:45 pm
- Examining the framework for calculations and reporting requirements under VHCA Section 603
- What is VA Office responsible for this Program?
- When must these calculations be reported to the VA?
- Implementing the correct formula for calculating the FCP
- “Nuts and Bolts” of the Non-FAMP and FCP Calculations
- Analyzing the interplay between FCP and Non-FAMP
- Determining the role of the Non-Federal Average Manufacturers Price (Non-FAMP) within the contracting process and ensuring the proper calculations
- What are the ways in which changes to Medicaid calculations can affect non-FAMP calculations?
- Identifying the sources of data necessary to calculate the non-FAMP
- Best practices for data collection to ensure accurate calculations
- Exploring the abnormalities seen when calculating the non-FAMP, and their causes
- Examining how FCP affects discounts related to pharmaceutical pricing discounts within the “Big Four” agencies
- Assessing the role of the price reduction clause
3:15 pm
Afternoon Break
3:45 pm
Our speakers will go through multiple in-depth mock calculations and illuminate how manufacturers can overcome calculation challenges and irregularities. Points of discussion include:
- Preparing for irregularities when calculating prices
- Penny pricing
- “Smoothing” prices
- Notifying the VA of these irregularities
- Correctly calculating pricing while incorporating lagged price reductions
- Assessing additional discount adjustments based on calculations
- Developing pricing calculations for new and transferred pharmaceuticals
- Maintaining compliance when communicating price reductions with wholesalers
- Securing sub-ceiling and non-ceiling sales related to the 340B program
- Assessing best practices to maintain for price calculations
4:15 pm
- 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
- Confidential Customer Contracts Claims
- Pre-award vs. Post-award Audits
- Determining a company’s obligations regarding record retention
- Avoiding actions that can result in costly penalties
- Efficiently conducting self-audits to ensure compliance
- Post award most important FAR/GSAR/VAAR clauses from a compliance standpoint
- Price Adjustments (Defective Pricing)
- Price Reductions
- Tracking Customer Price and Ratio
- Other potential FSS compliance traps
- Industrial Funding Fee
- Economic Price Adjustments
- Trade Agreements Act
- Modifications — Product Addition and Removal
- Potential penalties for non-compliance
- Key provisions of a compliance plan
- Enacting the proper steps for appealing decisions
5:15 pm
Day 1 Wrap-Up
Day 2
June 18, 2024
8:20 am
Co-Chairs’ Welcome Remarks
8:30 am
- Understanding the reasons for implementing a single or dual pricing model for Big Four contract(s)
- 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 an annual basis that may affect each of these pricing models
- 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 Federal Ceiling Price (FCP) effect on the expansion of the dual pricing model
- Assessing the benefits 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
9:30 am
- Examining the evolving compliance requirements for the System for Award Management (SAM)
- Outlining best practices to build a compliance program that fulfills the obligations of SAM
- Ongoing evaluation of risk management
- Forecasting timelines for registrations and renewals and how to prepare
- Assessing what information and documentation is required for SAM certification
- Requirements for domestic and foreign entities
- Practical examples of pitfalls that could be detrimental and how to avoid discrepancies
- FAR representations and certifications process and how it translates to SAM registration
10:15 am
Morning Break
10:30 am
In recent years, the increasing concern about the environmental impact of single-use plastic has become impossible to ignore. Drug manufacturers are at a crossroads meeting ESG requirements and using single use plastics for their products. This session will explore ESG reporting requirements and related obligations – as they apply to the Big Four — that manufacturers need to be aware of.
- Overview of annual and quarterly ESG reporting obligations
- Exploring single-use plastics used for prescription drugs
- Identifying other possible materials that manufacturers may substitute for plastic
- Pros vs. Cons
- Establishing best practices, policies, and processes to adhere to ESG obligations
- Devising a plan to best approach internal communication and coordination
11:15 am
In the last couple years, the US Government has been devising new rules to combat cybersecurity threats. As a result, federal contractors are required to provide cyber threat and incident reporting. This session will examine the specific obligations surrounding cybersecurity for each of the Big Four agencies.
- Examining evolving cybersecurity reporting obligations
- Is dual authentication sufficient?
- Analyzing how to comply with new affirmative action reporting obligations for federal contractors and subcontractors
- Devising optimal processes and policies to minimize exposure and risk
- What do manufacturers need to be mindful of?
- Identifying best practices for drug manufacturers to mitigate cyber risks
12:15 pm
Lunch
12:45 pm
- 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
1:45 pm
- What is a PHS 340B entity and why do they receive special pricing on drugs?
- PHS 602: navigating the complexities of determining who qualifies for 340B
- What steps does a 340B entity need to take to qualify for the program’s benefits?
- Key 340B program amendments
- Orphan drug limitation
- ADR process and civil money penalties
- Exploring 340B program growth
- HRSA 340B program enforcement
- Implications of recent cases
- Examining the latest developments in 340B related litigation and the implications for manufacturers
2:45 pm