Registration and Continental Breakfast
Chairs’ Opening Remarks
Sidley Austin LLP (Chicago, IL)
Breaking Down the President’s Blueprint and the Actions of HHS and CMS
Apperture LLC (New York, NY)
McDermott Will & Emery LLP (Washington, D.C.)
CEO and Owner
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
Associate General Counsel
UCB, Inc. (Atlanta, GA)
Director, Healthcare Policy, Medicaid, and State Initiatives
Biotechnology Innovation Organization
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
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
Covington & Burling LLP (Washington, D.C.)
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
Hooper, Lundy, & Bookman PC (Boston, MA)
Assistant United States Attorney
District of Massachusetts
Lee H. Rosebush
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
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
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?