Workshop A – Federal Programs 101: Primer for Professionals New to Pharmaceutical Pricing

Nov 27, 2018 9:00am - 12:00pm

Speakers

Merle M. DeLancey Jr.
Partner
Blank Rome LLP (Washington, D.C.)

Stephanie L. Kupski
Sr. Director, Pricing & Contracts
Horizon Pharmaceuticals (Lake Forest, IL)

Workshop B – Advanced Workshop on the National Contracting Process with the VA and DoD

Nov 27, 2018 2:00pm - 5:00pm

Speakers

Rick Moore
Senior Manager
Deloitte (Philadelphia, PA)

Clay Willis
Senior Manager
Deloitte (Mount Pleasant, South Carolina)

Day 1 - Wednesday, November 28, 2018

7:00
Main Conference Registration
8:00
Co-Chairs’ Opening Remarks
8:15
Examining the Differences in Government Price Calculations
9:00
Overview of Medicaid Price Calculations and Rebates: The Basic Building Blocks
10:15
Morning Networking Break
10:45
Medicaid Calculation Challenges: Delving Deeper into the Tougher Issues
12:00
Networking Lunch
1:00
Medicare Part B Drug Pricing
2:00
Managing the Implementation and Operational Challenges Resulting from Significant Changes to the 340B Program
3:15
Afternoon Networking Break
3:45
Medicare Part D Fundamentals and Updates
5:00
Conference Concludes for Day 1

Day 2 - Thursday, November 29, 2018

7:00
Registration and Continental Breakfast
8:00
Co-Chairs’ Recap of Day One
8:15
Incorporating Bona Fide Service Agreements in Pharmaceutical Pricing
9:15
Effectively Preparing for the Operational Challenges When Bringing a Drug to Market
10:30
Morning Coffee Break
10:45
Mastering Rebate Contracting Fundamentals and New Developments for Product Success
12:00
Main Conference Concludes
(Networking Lunch for Post-Conference Workshop C Attendees)

Workshop C – Negotiating, Drafting and Structuring Successful Value- Based Agreements

Nov 29, 2018 2:00pm - 5:00pm

Speakers

Dale Cooke
President
PhillyCooke Consulting (Philadelphia, PA)

Robert Hill
Partner
Reed Smith LLP (Washington, D.C.)

Trevor Wear
Partner
Sidley Austin LLP (Chicago, IL)

Rx Drug Pricing Master Class

Nov 30, 2018 7:00am - 5:45pm

Speakers

Trevor Wear
Partner
Sidley Austin LLP (Chicago, IL)

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

Jack Geisser
Director, Healthcare Policy, Medicaid, and State Initiatives
Biotechnology Innovation Organization

Nneka Onwudiwe
CEO and Owner
PECA, LLC

Constance Wilkinson
Member
Epstein Becker & Green, P.C.

Douglas Helling
Associate General Counsel
UCB, Inc. (Atlanta, GA)

Kristin Hicks
Partner
Arnold & Porter LLP

Linda Pissott Reig
Shareholder
Buchanan Ingersoll and Rooney PC (Newark, NJ)

Andrew Ruskin
Partner
Morgan, Lewis & Bockius LLP (Washington, D.C.)

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

James Stansel
Executive Vice President and General Counsel
PhRMA (Washington, D.C.)

Gregg Shapiro
Assistant United States Attorney
District of Massachusetts

Ambarish Ambegaonkar
Managing Partner
Apperture LLC (New York, NY)

David S. Schumacher
Partner
Hooper, Lundy, & Bookman PC (Boston, MA)

Lee H. Rosebush
Partner
Baker Hostetler (Washington, D.C.)

Day 1 - Wednesday, November 28, 2018

7:00
Main Conference Registration
8:00
Co-Chairs’ Opening Remarks

Cynthia Bass
Associate General Counsel
Sanofi (Bridgewater, NJ)

Robert Hill
Partner
Reed Smith LLP (Washington, D.C.)

8:15
Examining the Differences in Government Price Calculations

Stephanie Trunk
Partner
Arent Fox LLP (Washington, D.C.)

During this opening session, an in-depth analysis of government payor programs will look at the differences in the terminology and calculations amongst the federal programs, including the AMP, WAC, and BP (Best Price). In addition, discussion will include how a product may be covered under one program but not another, and the penalties assessed to companies for making incorrect statements and overcharging for a product.

9:00
Overview of Medicaid Price Calculations and Rebates: The Basic Building Blocks

Rick Moore
Senior Manager
Deloitte (Philadelphia, PA)

Elizabeth M. Wicyk-McGovern
Senior Manager Pricing & Reimbursement
Pfizer (Kenosha, Wisconsin)

  • Exploring how Average Manufacturer Price (AMP) is calculated
  • Defining “retail community pharmacy” class of trade (COT) for AMP calculations
  • Making COT assignments and why they are important
    • Understanding when to use “bill-to” and “ship-to” customers as the basis for COT assignments
  • Maintaining a COT schema
  • Employing customer and COT best practices
  • Making Best Price determinations
    • Determining what standard to use when initially reporting BP
    • Capturing stacked rebates
    • BP true-ups
  • Understanding the Unit Rebate Amount (URA) calculations
  • Base date AMP and the inflation penalty
  • Understanding state Medicaid programs
    • Fee for service
    • Medicaid Managed Care
    • State Pharmaceutical Assistance Programs (SPAPs)
    • Waiver programs
    • Part D Wraparound programs
    • Supplemental Rebates
  • Understanding the reimbursement process
  • Getting a drug on formulary
    • What are Preferred Drug Lists (PDLs) and what is the evaluation criteria before placing a drug on a PDL?
  • Processing state invoices
    • ROSI and PQAS

10:15
Morning Networking Break
10:45
Medicaid Calculation Challenges: Delving Deeper into the Tougher Issues

Cynthia Bass
Associate General Counsel
Sanofi (Bridgewater, NJ)

John Gould
Partner
Arnold & Porter LLP (Washington, D.C.)

Phillip Andrew Coburn
Director, U.S. Government Pricing Compliance
Pfizer (New York, NY)

  • Validating transactional data
    • Ensuring the completeness of direct sales, indirect sales, price concession (rebates, discounts, etc.), fee, returns, and adjustment data
  • AMP and BP included and excluded transaction types
    • Customary Prompt Pay Discounts (CPPD)
    • Chargebacks
    • Commercial rebates — when and how included?
    • Rebates for drugs reimbursed through federal government programs
    • Rebates for drugs reimbursed through SPAPs
    • Manufacturer coupons, vouchers and Patient Assistance Programs (PAPs)
    • Free goods — same product, other Medicaid product, and other items
    • Patient transactions — coupons, vouchers and patient assistance programs
    • Sales at nominal prices
    • Understanding what constitutes a bundle arrangement and developing an unbundling methodology
    • Invoice adjustments: Returns, price corrections and order corrections
  • Developing a smoothing methodology for lagged price concessions
  • Employing the 5(i) alternate AMP calculation
  • AMP calculation for non-5(i) products not generally sold to the retail community pharmacy COT
  • Calculating AMP for Authorized Generics (AGs) AMP and URA calculations for line extension products

12:00
Networking Lunch
1:00
Medicare Part B Drug Pricing

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

  • Understanding Part B pricing methodologies, coverage and coding
    • Average Sales Price (ASP)
    • Recognizing the differences in coverage, pricing and coding among various outpatient settings
  • Calculation of ASP
    • Inclusions and exclusions
    • Exempt and non-exempt sales
    • Smoothing
    • The three quarter lag
    • Free goods
    • Patient assistance
  • Submission of ASP data: timing
    • OIG and state AG efforts to obtain data
    • How late filed ASPs are dealt with when calculations are done?
  • Bundling
  • Special issues for radio-pharmaceuticals
  • Reimbursement of biosimilars under Part B
    • Managing coding protocols and a hybrid payment model

2:00
Managing the Implementation and Operational Challenges Resulting from Significant Changes to the 340B Program

William von Oehsen
Partner
Powers Pyles Sutter & Verville PC (Washington, D.C.)

  • Purpose and function of the 340B program
  • Understanding 340B pricing
    • Calculating 340B prices and understanding their relationship to Medicaid Drug Rebate Calculations
    • Estimating PHS prices for new drugs
  • Examining the reimbursement cuts to 340B hospitals
  • Update on the CMP final rule
    • Penny pricing
    • Distribution systems
    • Calculation of the 340B price
  • 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?
  • 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
  • 340B pricing for multi-source drugs
  • Treatment of 340B sales in other federal drug pricing calculations
  • 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
  • Exploring how URA cap can impact penny pricing
  • Recalculating the PHS price for “line extension” products
  • 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

3:15
Afternoon Networking Break
3:45
Medicare Part D Fundamentals and Updates

Tom Evegan
Managing Director
Cumberland Consulting Group LLC (Edison, NJ)

  • Understanding the mechanics of how Part D is run
    • What subsidies and payments do Part D plans receive?
    • Interaction with 28% Retiree Drug Subsidy and commercial rebates
  • Reporting of Part D rebates and PBM administrative fees
  • Part D fraud & abuse issues
  • Part D formulary requirements
  • Rebate contracting strategies under Part D
  • Taking advantage of plan Star Ratings
  • Accounting for specialty pharmaceuticals
  • Potential legislative changes
  • Understanding the CMS program design relative to the Part D Coverage Gap Discount
  • Managing the logistics of payments to multiple plan sponsors
  • Assessing CGDP payment disputes
  • Conducting CGDP audits

5:00
Conference Concludes for Day 1

Day 2 - Thursday, November 29, 2018

7:00
Registration and Continental Breakfast
8:00
Co-Chairs’ Recap of Day One
8:15
Incorporating Bona Fide Service Agreements in Pharmaceutical Pricing

William Davis
Member
Mintz Levin Cohn Ferris Glovsky and Popeo PC

Julie DeLong
Senior Managing Director
Ankura Consulting Group, LLC (Atlanta, GA)

Rick Zimmerer
Partner
KPMG LLP (Los Angeles, CA)

  • Breaking down the four part test in determining a bona fide service fee
    • What are the quantitative aspects of the test?
    • What are some of the fees that do not qualify?
  • What manufacturer relationships are in place?
  • Which are the entities recognized as “bona fide” by CMS?
  • Managing rebates in regards to bona fide service fees
  • Strategies for proper price reporting for transparency
    • What is the impact on the AMP?
  • Block Pricing
  • Properly reporting administrative service fees
  • Discussing the treatment of PBM administration as bona fide service fees
  • What risks exist for non-compliance with the rule?

9:15
Effectively Preparing for the Operational Challenges When Bringing a Drug to Market

Lynn Robson
Division Counsel, Managed Care and HEOR
AbbVie Inc. (Chicago, IL)

T Reed Stephens
Partner
McDermott Will & Emery LLP (Washington, D.C.)

  • What are the steps to properly setting a launch price?
  • What lead-time is necessary?
  • Exploring the pricing as an existential issue to the manufacturer facing issues from a number of different fronts
  • What is the role of a pricing committee?
  • Which departments should have a representative on a pricing committee?
    • Legal
    • Finance
    • Compliance
    • Supply Chain
    • Sales
  • What perspectives are required from the members of the committee?
    • What are the potential positives and pitfalls?
  • How does the committee properly document decisions?
  • Who are the executives whom must provide a final sign off on the pricing?
  • How does a pricing committee provide transparency for the pricing process in general?
  • Can pricing functions be outsourced?
    • What additional risks exist by outsourcing the pricing function and the potential benefits?
  • Exploring the uses of the traditional computer pricing systems (Model N, Revitas, iContracts) in pricing and price reporting
    • What are the challenges in implementation?
  • What are the best practices for merging companies to combine their pricing data?
  • Examining the need for a 3PL
  • What is the transition process to the FSS?

10:30
Morning Coffee Break
10:45
Mastering Rebate Contracting Fundamentals and New Developments for Product Success

Robert Hill
Partner
Reed Smith LLP (Washington, D.C.)

  • Dealing with ramifications of potential changes in Safe Harbor protection for Plan/PBM rebates
  • Comparing and contrasting key contracting and administrative differences, including “best price,” price reporting, and double dipping, by book of business
    • Part D
    • Managed Medicaid
    • Exchange Plans
    • Commercial
  • Rebate contracting for drugs, biosimilars, and branded biologics covered under medical, not pharmacy, benefit plans
    • Understanding potential links to specialty pharmacy arrangements
    • Exploring the interaction with physician/provider discount strategies
  • Analyzing requirements for disclosure or pass-through of rebates or administration fees to plan clients
    • Understanding risks when contracting with PBMs for specialty and mail order pharmacy purchase discounts
  • Identifying and outlining best practices relating to major rebate contracting issues
    • Price protection and inflation guarantees
    • PBM bidding rules and requirements
    • Termination rights
    • Obligations to pay rebates following divestiture of product
    • Audit rights

12:00
Main Conference Concludes
(Networking Lunch for Post-Conference Workshop C Attendees)

Rx Drug Pricing Master Class

Nov 30, 2018 7:00am - 5:45pm

$1,395

Speakers

Trevor Wear
Partner
Sidley Austin LLP (Chicago, IL)

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

Jack Geisser
Director, Healthcare Policy, Medicaid, and State Initiatives
Biotechnology Innovation Organization

Nneka Onwudiwe
CEO and Owner
PECA, LLC

Constance Wilkinson
Member
Epstein Becker & Green, P.C.

Douglas Helling
Associate General Counsel
UCB, Inc. (Atlanta, GA)

Kristin Hicks
Partner
Arnold & Porter LLP

Linda Pissott Reig
Shareholder
Buchanan Ingersoll and Rooney PC (Newark, NJ)

Andrew Ruskin
Partner
Morgan, Lewis & Bockius LLP (Washington, D.C.)

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

James Stansel
Executive Vice President and General Counsel
PhRMA (Washington, D.C.)

Gregg Shapiro
Assistant United States Attorney
District of Massachusetts

Ambarish Ambegaonkar
Managing Partner
Apperture LLC (New York, NY)

David S. Schumacher
Partner
Hooper, Lundy, & Bookman PC (Boston, MA)

Lee H. Rosebush
Partner
Baker Hostetler (Washington, D.C.)

What is it about?



This Rx Drug Pricing Master Class will address the hottest and most up-to-date legal and compliance pricing issues currently impacting everyone in the pharmaceutical industry, including pricing transparency initiatives, enforcement trends, and the recent President’s Blueprint to lower drug prices.

Friday, November 30, 2018

7:00
Registration and Continental Breakfast
8:00
Chairs’ Opening Remarks

Trevor Wear
Partner
Sidley Austin LLP (Chicago, IL)

8:15
Breaking Down the President’s Blueprint and the Actions of HHS and CMS

Ambarish Ambegaonkar
Managing Partner
Apperture LLC (New York, NY)
 
James Kim
Partner
McDermott Will & Emery LLP (Washington, D.C.)
 
Nneka Onwudiwe
CEO and Owner
PECA, LLC.
 
Constance Wilkinson
Member
Epstein Becker & Green, P.C.
 
On May 11th, 2018, President Donald Trump released his blueprint to improve pricing transparency and combat the rising costs within the pharmaceutical industry. Following the release of this blueprint, major pharmaceutical companies have begun releasing transparency reports, and CMS has implemented a “dashboard” which illustrates spending information for Medicare Parts B and D, as well as Medicaid.
 
Points of discussion will include:

  • Exploring the short term and long terms goals of the plan
  • What regulatory and legislative changes would be necessary to enact the plan?
  • The elimination of rebates under the safe harbor discount statute
  • Treating PBM’s as fiduciaries
  • Implementing FDA mandatory pricing disclosures
  • MEDPAC and Medicare Part B reform
  • The creation of an AMP cap
  • What are the revised penalties for the abuse of Medicare rebates?
  • What changes have occurred on the operational level?
  • Evaluating the inclusion of prices in drug makers’ ads to enhance price competition
  • The status of the HHS survey and CMS dashboard and the actions taken based on these implementations
9:30
Discussing the Effects of State Transparency Laws on Drug Pricing

Douglas Helling
Associate General Counsel
UCB, Inc. (Atlanta, GA)
 
Jack Geisser
Director, Healthcare Policy, Medicaid, and State Initiatives
Biotechnology Innovation Organization
 
Kristin Hicks
Partner
Arnold & Porter LLP

  • What states have put regulations into place in regards to pricing transparency?
    • What are the similarities and differences amongst them?
    • What is the standing of state legislation currently challenged in court?
    • What are the implications for pharmaceutical companies doing business in these states?
  • Best practices for companies to comply with multiple state’s transparency laws
  • Exploring the effects of the 4th Circuit’s ruling on Maryland’s price gauging law and how it could impact transparency in other states
    • How will the interstate commerce clause influence these laws?
  • How have recent court rulings on the state level affected transparency laws moving forward?
    • Exploring Oregon’s pending pricing transparency law
  • How does state transparency affect the setting of list prices and the WAC?
  • What are the operational challenges that exist from the call for transparency on the state level?
  • What are the issues to consider when disclosing pricing information to a state?
    • Who is responsible for compliance?
    • What effect does the “Sunshine Act” have on this?
  • Evaluating the status of a federal transparency law
    • What role will HHS and CMS play in this?
  • Discussing the effects of Medicaid Drug Cap laws on state transparency
10:45
Morning Coffee Break
11:00
Exploring the Role of Co-Pay Coupons, Accelerators, and Maximizers in Pharmaceutical Pricing

Linda Pissott Reig
Shareholder
Buchanan Ingersoll and Rooney PC (Newark, NJ)

  • Defining the different types of programs
  • Exploring the process for working with a coupon vendor
  • How are the parameters for the program set?
  • What are the types of pharmaceuticals sold under these models?
  • Is a manufacturer required to pay multiple discounts for a drug offered under one of these models?
  • Proper use of distribution vendors and methods for reporting these sales
  • Examining the HHS blueprint as to whether coupons should be considered a discount for Medicaid drug rebates
  • Discussing the role of 501(c)(3) charities
  • Strategies being used by insurers to extend the “deductible phase”
  • What are the proper price reporting policies?
  • How do maximizers and accumulators influence best price?
  • What is the level of government reimbursement?
  • How does managed care effect price reporting?
  • What are the impacts of these programs on the patient?
12:15
Networking Lunch
1:30
“Ripped from the Headlines” – A Look at Current Issues in Rx Pricing

Jennifer Plitsch
Partner
Covington & Burling LLP (Washington, D.C.)
 
James Stansel
Executive Vice President and General Counsel
PhRMA (Washington, D.C.)

This session will look into the latest breaking news, and its impact on pharmaceutical pricing. Topics of discussion include an update on the mid-term elections and their relation to the industry, recent legislation, budgets, hearings, and potential congressional investigations. In addition, speakers will explore of the current focus of trade associations such as PhRMA, as well as the latest mergers and acquisitions within the pharmaceutical space. Finally, there will be an analysis of the industry’s ability to narrow the gap between manufacturer list price and market sales price, and price reporting issues related to compounding drugs on the federal and state level.

2:15
Exploring the Current Enforcement Trends on the Federal and State Levels

David S. Schumacher
Partner
Hooper, Lundy, & Bookman PC (Boston, MA)
 
Gregg Shapiro
Assistant United States Attorney
District of Massachusetts
 
Lee H. Rosebush
Partner
Baker Hostetler (Washington, D.C.)

  • Current DOJ and state actions
  • False Claims and FCA liability in relation to companies pre-determining markets for pharmaceuticals
    • Failure to return overpayments
    • Are maximum acquisition costs inflated?
    • Are you required to report these issues to federal regulators?
  • What liabilities exist to the individual
    • How does one verify the accuracy of all documentation?
  • Benchmarking the internal protocol for these situations
  • The proper use of a reasonable assumptions letter
    • When do you need to disclose to the government?
    • When does no risk exist, assuming a memo has been included with the price-reporting file?
  • Discussing the DOJ’s increased interest in rebates being provided to health plans in relation to co-pay assistance
3:15
Afternoon Networking Break
3:30
Overcoming New and Evolving Challenges in the Pricing of Specialty Products

Andrew Ruskin
Partner
Morgan, Lewis & Bockius LLP (Washington, D.C.)

  • What qualifies as a specialty pharmaceutical, and how are they different from other drugs?
  • What are some of the factors considered when pricing a specialty product?
  • Evaluating the EpiPen hearings and their impact on pricing
  • The impact of Trump’s White Paper and any implementation thereof on SP products
  • Adhering to HRSA’s 340B requirements with respect to limited distribution drugs
  • Choosing a specialty pharmacy distribution chain, a buy and bill distribution chain, or both
  • Rules regarding “bridge” programs
  • What are the pricing and contracting compliance issues that exist in personalized medicine and gene therapies?
  • Discussing bills at the federal and state levels in relation to opioids
    • What theories are states using against opioid manufacturers that effect pricing?
    • The recent tax in New York on opioids within the state
    • What other states are planning to tax the product?
  • Exploring the rising prices on opioid inhibiting drugs
  • What are the evolving pricing risks going forward?
4:30
PBM’s and the Verticalization of the Pharmaceutical Industry

Trevor Wear
Partner
Sidley Austin LLP (Chicago, IL)

  • Examining the role of the PBM and the wholesaler within the industry
  • How the verticalization of the industry effects best price and value based agreements
  • Exploring the relationship of the pharmaceutical companies with PBM’s
  • What transparency currently exists in relation to PBM’s
  • How will changing the discount safe harbor effect PBM’s
  • What effect do PBM’s and GPO’s have on calculations?
    • Are the expenses of using these services a fee or a concession in relation to Medicare Part B?
    • How do these services work with Medicare Part D and what are the reporting responsibilities?
  • What are the DIR fee reporting requirements for Medicare?
  • How does consolidation of the industry influence drug pricing moving forward?
5:45
Conference Concludes

Workshop A – Federal Programs 101: Primer for Professionals New to Pharmaceutical Pricing

Nov 27, 2018 9:00am - 12:00pm

$600

Speakers

Merle M. DeLancey Jr.
Partner
Blank Rome LLP (Washington, D.C.)

Stephanie L. Kupski
Sr. Director, Pricing & Contracts
Horizon Pharmaceuticals (Lake Forest, IL)

What is it about?

This workshop will provide you with an essential overview of pharmaceutical pricing and government payor programs. It will serve as a primer on the fundamentals of government pricing and lay the foundation for the more in depth discussions that will take place throughout the conference.

  • Survey of applicable drug pricing legislation such as the MMA, DRA, and PPACA
    • Related agency rules/guidance
  • Tracing the flow of payments and reimbursements in the health care supply chain
    • Identifying stakeholders within the chain and their roles
    • Tracking the flow of drugs, payments and services
  • Deciphering commonly used acronyms and terminology
  • Overview of different pricing benchmarks and calculations
    • AMP, AWP, ASP, WAC, BP, PHS, FCP, and non-FAMP
  • Understanding the implications of different pricing methodologies, calculations and benchmarks for different stakeholders
  • Examining the key pricing concepts and calculations for government drug pricing and rebate programs
    • Medicaid Drug Rebate Agreement program overview
    • Medicare Part B
    • 340B Drug Pricing program
    • Federal Supply Schedule/Federal Ceiling Price
    • Medicare Part D
    • TRICARE
  • Identifying similarities and differences among the programs
  • Considering the interactions among the programs
  • Understanding how participation in the Medicaid Drug Rebate Program affects participation in the PHS 340B and VA programs
    • How the PHS program links to Medicaid

 

12:00 PM – 1:30 PM
Lunch for Attendees of Workshop A and B Only

Workshop B – Advanced Workshop on the National Contracting Process with the VA and DoD

Nov 27, 2018 2:00pm - 5:00pm

$600

Speakers

Rick Moore
Senior Manager
Deloitte (Philadelphia, PA)

Clay Willis
Senior Manager
Deloitte (Mount Pleasant, South Carolina)

What is it about?

In this in-depth pre-conference workshop, you will receive perspective on the steps involved in working with both Veteran Affairs and the Department of Defense in the National Contracting Process, including what to do prior to receiving a contract, what happens once the contract has been awarded, and the process to getting your contract successfully renewed.

  • Exploring what is needed for a drug to be eligible for consideration
    • Standardization versus therapeutic interchange contracts
  • Analyzing how target drugs are chosen by VA/DoD/IHS/BOP for joint national contract targets
  • What are the general requirements for issuing a drug contract?
    • Package size considerations
    • Bottle caps
    • Safety seals
    • 30% up front requirement for VA mail order
  • Understand the factors for creating the requirements in the estimated volume of purchase
    • Formulary status changes
    • Automatic substitution by Pharmaceutical Prime Vendor
    • Changes with pricing for other drugs in the class
  • Examining the contracting process
    • Pre-solicitation
    • Solicitations
    • Post-Solicitation discussions
  • What is the process for having the contract for a drug renewed?
  • Identifying the factors considered by the agencies when a drug is up for renewal
    • Supply issues
    • Comparative pricing
  • Understanding the differences in the processes used by the VA National Acquisition Center and Defense Logistics Agency

 

12:00 PM – 1:30 PM
Lunch for Attendees of Workshop A and B Only

Workshop C – Negotiating, Drafting and Structuring Successful Value- Based Agreements

Nov 29, 2018 2:00pm - 5:00pm

$600

Speakers

Dale Cooke
President
PhillyCooke Consulting (Philadelphia, PA)

Robert Hill
Partner
Reed Smith LLP (Washington, D.C.)

Trevor Wear
Partner
Sidley Austin LLP (Chicago, IL)

What is it about?

Value- based contracts, sometimes referred to as risk sharing agreements between pharmaceutical manufacturers and insurers/payors are critical in today’s very complex and costly healthcare marketplace. These agreements allow placement of high-risk, high-cost and oftentimes specialty pharmaceutical products onto payor formularies through basing payment on outcomes as opposed to volume metrics. The concept has become popular in single payor systems, and has become more common within the U.S. as evidenced by several high profile value based contracts between pharmaceutical manufacturers and insurers. However, as with every new concept in the U.S. health care arena, there are growing pains, fear and uncertainty. This workshop will provide tactics and techniques for the successful execution of these vital agreements. Points of discussion will include:

  • Assessing value and defining risk from both the manufacturer and payor perspectives
    • the role of third party data assessors in value determinations
  • Negotiating contract terms within risk definition and risk tolerance of both parties
  • Structuring the agreement in such a way that both manufacturer and payor share risks and benefits in as fair a way as possible
  • Exploring consequences of not meeting outcome
  • Establishing criteria for proving outcome and value of product
    • time tables for results
    • determining which of the parties will be responsible for data collection
    • using outside parties to collect data
    • rules for data collection and interpretation
    • determining which party will evaluate the basis of outcome
    • determining payment increase for proven value
  • Exploring the possibility of incorporating volume metrics together with outcomes metrics for payment to offset manufacturer risk
  • Identifying special concerns with value based agreements with non-traditional payors such as hospitals, hospital systems, integrated delivery networks (IDNs) and ACOs
  • Identifying challenges regarding rebates and government programs and incorporating provisions in regard to these agreements to compliantly address
    • best price calculations
    • price reporting
    • bundled payments
  • The impact of the FDA guidance on payor communications on value-based contracting
  • Implications of potential Safe Harbor changes, and ways to address uncertainty in agreements signed now