May 24-25, 2021
Online Livestream
Rx Pricingand Reimbursement
Developing Strategies to Comply with Government Regulations and Overcome Challenges in Calculations
Pharmaceutical pricing has always been a focus of lawmakers of the federal and state levels alike. With the recent mulitutde of executive orders and an increase in calls for pricing transparency from all levels of government, navigating this space has become more complicated than ever before. With this in mind, DGE’s Rx Pricing and Reimbursement conference has been developed to provide an in-depth look at the issues facing the industry today. Join us on our fully interactive platform as a faculty of industry leaders provide you with the information needed for submitting successful FSS proposals and adapting methodologies to remaining compliant with ever-changing government regulations.
Agenda at a Glance

Topics covered will include:

  • Discuss the Latest Pricing Challenges Surrounding the 340B Program
  • Explore the Changes to Rebates and Safe Harbor Effecting Medicare Part D
  • Analyze Newly Developed Federal Pricing Transparency Laws in Public Payor Programs
  • Analyze the Final Rule on the Importation of Pharmaceuticals
  • Discuss the Recent Development of the “Most Favorite Nations” Rule
Top Reasons to Attend
  • An in-depth look at the current status of the proposed 340B contract pharmacy rule
  • Discussion on the IPI in relation to Medicaid pricing
  • Thorough review of th increase in state regulations and the call for pricing transparency
  • Strategies to navigate the verticalization of the pharmaceutical pricing industry
Who Should Attend
This conference is designed for senior leaders and executives in pharmaceutical, biotech, and medical device companies responsible for:
  • Market Access
  • Government Pricing
  • Compliance
  • Ethics
  • Legal Affairs
  • Transparency Reporting
  • Aggrigate Spending
  • Auditing
  • Monitoring
  • Investigations
  • Training
  • Oversight
  • Risk Management
  • Patient Support
New Topics
Featured Speakers
Amie Phillips Pablo
Novo Nordisk
Director, Ethics & Compliance
Donna White
Chiesi USA
Vice President, Compliance
Greg Madden
Orlaithe Consulting LLC
Managing Member
Gregg Shapiro
United States Attorney’s Office, District of Massachusetts
Chief, Affirmative Civil Enforcement Unit
James Kim
McDermott Will & Emery LLP
Jim Stansel
General Counsel
John Murphy III
Biotechnology Innovation Organization
Vice-President, Assistant General Counsel
Judy Waltz
Foley & Lardner LLP
Keren Tenenbaum
VP and Assistant General Counsel, Head of Legal
Mallory O’Connor
Mallinckrodt Pharmaceuticals
Executive Director, Public Policy
Michael Grivnovics
Veterans Affairs Office of the Inspector General
Director, Federal Supply Schedule Division
Nicholas Uehlecke
U.S. Department of Health and Human Services
Former Senior Advisor
Robert Hill
Reed Smith LLP
Rodney Emerson
Executive Director, Pricing and Contracts
Shraddha Eswaran
Lupin Pharmaceuticals
Government Pricing Analyst
Stephanie Trunk
Arent Fox LLP
Trevor Wear
Sidley Austin LLP
Event Schedule

How will the Biden Administration’s agenda impact prescription pricing and reimbursement? The session explores policies which have already been put into place, as well as where the administration’s focus will remain for the next four years. 

One of the final acts on the Trump Administration was to issue an executive order focused on the 340B program. As this may have major effects on the pharmaceutical industry, it is essential that manufacturers have a firm understanding of its status for their continuing participation in the Medicaid program.  

  • Analyze challenges in offering 340B pricing to contract pharmacies
  • Explore the advisory opinion released by HHS
  • Examine ongoing litigation opposing the final rule

While the Trump Administration’s “Rebate Rule” modifications to the AKS safe harbors have been postponed, the Biden Administration and Congress may move forward with those or other changes that would significantly affect the rebates and coverage gap discounts that manufacturers currently pay. This session explores potential changes and their impacts on Medicare pricing strategies. 

• Evaluate the current status of the Rebate Rule and the potential fate of each of its elements 
• Discuss last-minute Trump PDM Model modifications eliminating Part D coverage requirements for 5 of 6 protected classes 
• Analyze implications of a restructuring of the Part D benefit, such as previously approved by the Senate Finance Committee 
• Consider potential Biden Administration regulatory and legislative proposals to control drug prices under Part D.

The submission of a bid to the federal supply schedule provides the opportunity to obtain a contract with federal, state and local governments so they may act as purchasers of a product following volume discount pricing. This session explores strategies for submitting bids to win FSS contracts.

  • Understand the format and language you must use in your FSS bids
  • Develop responses to potential requests from the Veterans Affairs during the bidding process
  • Examine the methodology utilized by the Veterans Affairs in the selection process

In November 2020, HHS released a final rule requiring health insurers to disclose drug pricing costs, as well as cost-sharing information to participants in their plans. Are you prepared to comply with these changes in transparency requests?

  • Explore the tool which insurers must develop to provide patients with an out-of-pocket estimate 
  • Examine the effect of the rule on negotiations between manufactures, PMBs and health insurers
  • Discuss the exemption to the rule for Medicaid and Medicare

Year after year calls continue to grow for Rx pricing transparency on the state level. While under federal guidance, each state individually manages its own Medicaid program and these requests cannot go unanswered. The session explores the latest rules and regulations implemented by the states. 

While value-based contracting is not something that is necessarily new, the utilization of this pricing model continues to increase in the world of specialty pharmaceutical and orphan drugs. There are a wide variety of agreement types potentially available for providers of these drugs. 

  • Examine the differences in developing a contract based on value rather than volume
  • Determine the KPIs which will determine the value of a drug

In December 2019, HHS and FDA issued a joint proposed rule which would allow for the importation of pharmaceuticals from Canada at the sole discretion of HHS. With the final rule issued in December, HHS now allows importation of these products assuming the product poses no threat to the health and safety of the American public. 

  • Discuss the effects on US manufacturers based on the pricing differential with Canadian pharmaceuticals and the cost savings involved
  • Examine the legislative action states are taking to allow for the importation of pharmaceutical products
  • Review the response from US manufacturers to the implementation of the rule

President Trump issued his Most Favorite Nation Rule (MFN) in September 2020 to the shock of everyone in the pharmaceutical industry. This would completely change current pricing models and calculations for Medicare Parts B &D.

  • Examine the International Pricing Index (IPI) and effects this may have on the price of pharmaceuticals for public payors 
  • Analyze the pricing calculations in relation to Best Price
  • Discuss recent legal challenges to the rule

The ongoing battle between manufacturers and service providers about co-pay coupons, maximizers and accumulators only continues to escalate. With the recent “CAAP” regulation issued from HHS, manufacturers take a hard hit in the pricing war. 

  • Discuss the ability of insurers to accept co-pay coupons without reducing the out-of-pocket expenses of the patient
  • Explore potential violations of the out-of-pocket maximums listed in the Affordable Care Act

Continuous mergers between PBMs, pharmacies and plans continue to keep manufacturers at a disadvantage when negotiating contracts. With these entities holding much of the bargaining power, manufacturers must be aware of challenges they may face in the negotiating process. 

  • Explore recent mergers 
  • Analyze the role of the Group Purchasing Organization in negotiations
  • Examine the stacking of rebates to determine Best Price
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