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.
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
Registration and Continental Breakfast
Chairs’ Opening Remarks
Trevor Wear Partner Sidley Austin LLP (Chicago, IL)
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
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
Morning Coffee Break
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?
“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.
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
Afternoon Networking Break
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?
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?
Workshop A – Federal Programs 101: Primer for Professionals New to Pharmaceutical Pricing
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
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, 20182:00pm - 5:00pm
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
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
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
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, 20182:00pm - 5:00pm
Dale Cooke President PhillyCooke Consulting (Philadelphia, PA)
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
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