Agenda
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- At a Glance
- Day 1
- Day 2
- Day 3
- Day 4
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Day 1 - Monday, April 28, 2014
| 1:00 |
Pre-Conference Workshop |
Day 2 - Tuesday, April 29, 2014
| 7:30 |
Registration and Continental Breakfast |
| 8:30 |
Chair’s Opening Remarks |
| 8:45 |
Part 1 – Overview of Medicaid Rebate: The Basic Building Blocks |
| 10:00 |
Morning Coffee Break |
| 10:15 |
Part 2 – Medicaid Rebate Challenges: Delving Deeper into the Knotty Issues |
| 11:30 |
Developing Drug Pricing Strategies in an Evolving Federal Policy Environment: Health Care Reform and Beyond |
| 12:30 |
Networking Luncheon |
| 1:45 |
State Medicaid Programs and Their Relationship to the Federal Rebate System |
| 2:45 |
Medicare Part B Drug Pricing |
| 3:45 |
Afternoon Coffee Break |
| 4:00 |
AWP (Average Wholesale Price) and Industry’s Search for a Viable Replacement Pricing Benchmark |
| 4:30 |
Pricing Under the Public Health Service 340B Program |
| 5:30 |
Conference Adjourns to Day 2 |
Day 3 - Wednesday, April 30, 2014
| 8:00 |
Registration and Continental Breakfast |
| 8:50 |
Opening Remarks from Conference Chair |
| 9:00 |
Medicare Part D: Fundamentals, Updates, and Operationalizing the Coverage Gap Discount Program |
| 10:00 |
Understanding Opportunities and Pitfalls When Contracting with ACA Exchange Qualifi ed Health Plans |
| 11:00 |
Morning Coffee Break |
| 11:15 |
Managing the Operational Challenges of Government Prices: How to Get From Policy to Practice |
| 12:15 |
Networking Luncheon |
| 1:30 |
Understanding Reimbursement Changes and Enforcement Initiatives Relevant to Generic Drugs |
| 2:30 |
Networking Coffee Break |
| 2:45 |
Understanding the False Claims Act (FCA) and Ongoing Government Enforcement and Compliance Efforts |
Day 4 - Thursday, May 1, 2014
| 9:00 |
Post-Conference Workshop |
Day 1 - Monday, April 28, 2014
| 1:00 |
Pre-Conference WorkshopGovernment Payor Pricing 101: Primer for Professionals New to Pharmaceutical PricingWilliam A. Sarraille John D. Shakow This workshop will provide you with a basic overview of pharmaceutical pricing and government payor programs. This pre-conference workshop serves as a primer on the fundamentals of government pricing and will prepare you for the more in-depth discussions that will take place throughout the conference. • Tracing the history of applicable legislation such as the MMA, DRA, and PPACA • Tracing the flow of payments and reimbursements in the health care supply chain – Identifying stakeholders within the chain and their roles – Tracking the fl ow 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 program – 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 • Overview and analysis of the National Rebate Agreement: its origins and significance • Review of the agreement’s terms and requirements for participation • Understanding why participation in the Medicaid outpatient drug program is contingent on participation in the PHS 340B and VA programs – How is the PHS program linked to Medicaid? • Analyzing the relationship of the National Rebate Agreement to the Medicare Drug benefit? (i.e., Medicare Part D) • Identifying the changes resulting from the enactment of the Patient Protection and Affordable Care Act (PPACA) and the Health Care and Education Affordability Reconciliation Act
1:00 p.m. – 4:00 p.m. (Registration begins at 12:30 p.m.) |
Day 2 - Tuesday, April 29, 2014
| 7:30 |
Registration and Continental Breakfast |
| 8:30 |
Chair’s Opening RemarksLarri A. Short |
| 8:45 |
Part 1 – Overview of Medicaid Rebate: The Basic Building BlocksJohn D. Shakow Kathleen A. Peterson • Understanding the rebate formulas and the Unit Rebate Amount (URA) calculation • Average Manufacturer Price (AMP): what is it and how is it calculated? – What is included and excluded from the calculation? • What is Best Price and how is it calculated? – What is included and excluded? – Branded and generic product examples • Key definitions applicable to both AMP and Best Price – Bona fide service fees; bundled sales – Customary prompt pay discounts • Making class of trade classifi cations and why they are important • Lagged and non-lagged concessions • Smoothing; Bundling • Bona fide services fees and administrative fees • Rebate segment mechanics • Base data AMP and the infl ation penalty • What do invoices look like? – ROSI and PQAS; how to validate the rebate
|
| 10:00 |
Morning Coffee Break |
| 10:15 |
Part 2 – Medicaid Rebate Challenges: Delving Deeper into the Knotty IssuesWilliam A. Sarraille T. Reed Stephens • How does the new AMP definition affect AMP calculations? – Calculating AMP for products that are not sold to community retail pharmacies • The 5(i) alternative calculation • Rebates to managed care organizations • Issues around the “default” rule • Authorized generics • Problems in bona fi de service fees: reconciling the different definitions • How are manufacturers addressing the change in the AMP definition? • Medicaid reimbursement provisions in health care reform • Public availability of AMP • Implications of the 100% cap on the URA for 340B prices • Pricing of line extension products • Systems confi guration and maintenance in light of health care reform
|
| 11:30 |
Developing Drug Pricing Strategies in an Evolving Federal Policy Environment: Health Care Reform and BeyondSteven K. Stranne MD, JD • The potential impacts of federal policy developments • The possibility of changes to the average sales price (ASP) methodology • The relevant provisions and ongoing implementation of the Affordable Care Act • Potential impacts of innovative delivery models, including but not limited to accountable care organizations • Comparative effectiveness research • Issues arising from federal efforts to address drug shortages • Considerations related to the policy debates over the sustainable growth rate (SGR) formula and other relevant issues
|
| 12:30 |
Networking Luncheon |
| 1:45 |
State Medicaid Programs and Their Relationship to the Federal Rebate SystemPaula Martins • Understanding how state Medicaid programs operate – Identifying the unique features and key differences of the various state programs – Understanding how drugs in various states are actually reimbursed • Complying with state reporting requirements – What states have reporting requirements? – What are the reporting requirements? – How will changes to the AMP definition impact manufacturers’ reporting requirements • Getting a drug on formulary – What are Preferred Drug Lists (PDLs) and what criteria are evaluated before a drug is placed on a PDL? • State Pharmaceutical Assistance Programs(SPAPs) • Supplemental Drug Rebate Agreements • What impact could the calculation of new URAs have on SPAPs and Supplemental Agreements? • Understanding how Medicaid Managed Care programs operate – Who are these entities? – How are the formularies run? How much control do the plan sponsors have over the formulary versus the state? • Inclusion of Medicaid Managed Care programs in the federal rebate program – Assessing the impact this will have on negotiated discounts/rebates between plan sponsors and manufacturers Preparing for the possibility of double discounts – recognizing which Medicaid managed care plans are covered under the federal statute requirements and which are not – How will inclusion in the federal rebate program affect formularies and PDLs? – What impact will the inclusion in the federal rebate program have on manufacturers’ rebate strategies? • Accruing for rebates in light of changes to Managed Medicaid • How are states planning to implement the requirements mandated by the federal government? – Where will the money for implementation come from? • The issues in Texas: where do they stand?
|
| 2:45 |
Medicare Part B Drug PricingJudith A. Waltz • 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 – Bona fide service fees – Free goods – Patient assistance – Coupons • Submission of ASP data: timing – OIG and state AG efforts to obtain data – How will late filed ASPs be dealt with when calculations are done? How will the data gaps be filled? • CMS’s proposed treatment of “intentional overfill” – How will ASP be calculated for “overfi lled” products? • Bundling • Special issues for radio-pharmaceuticals • Reimbursement of biosimilars under Part B – Managing new coding protocols and a hybrid payment model • Preparing for the trend toward ACOs and new payment models that may be evolving. – Policy issues – Medicare proposed models that emphasize cost saving, e.g., accountable care – Outcomes – passed rebates • WAMP, AMP, LCA, and other possible risks in light of the deficit reduction efforts
|
| 3:45 |
Afternoon Coffee Break |
| 4:00 |
AWP (Average Wholesale Price) and Industry’s Search for a Viable Replacement Pricing BenchmarkWilliam A. Davis • How to minimize risk under current system and evolving potential future system – Where are we in this process? – When will it be over? • When and why is AWP still used for reimbursement? • Understanding what constitutes WAC and how it is used – Other terms manufacturers substitute for WAC • Setting AWP and WAC – The role of 3rd party pricing compendia with respect to AWP and WAC • Examining the effect of AWP litigation on the continued use of this pricing methodology – Lessons learned from the AWP cases before Judge Saris Should we be modifying behavior? – Update on state AWP cases • Assessing the impact of health care reform on different pricing benchmarks (AMP, AWP, and WAC) • What replacement metric should take the place of AWP and what the challenges are associated with those metrics? • Pharmacy acquisition costs
|
| 4:30 |
Pricing Under the Public Health Service 340B ProgramWilliam H. von Oehsen III Joseph W. Metro • Responding to a new era of oversight and enforcement: recertification of all 340B entities – What is the latest with these audits? – Are they uncovering diversion? – What are HRSA’s findings? – What are the outcomes of audits by the manufacturers? – What are the implications of those findings for the future of the program? • Evaluating the forthcoming rule – Emerging issues – Dispute resolution • Identifying 340B “covered entities” and “new” covered entities created under PPACA – How are new covered entities being added? • Orphan drug exclusions for new covered entities • Understanding the patient rule under 340B • Truing up 340B prices if and when prices are restated for Medicaid rebate purposes • Restrictions for participating covered entities – The anti-diversion provision – Prohibition against duplicate discounts – How can manufacturers ensure covered entities are complying with these restrictions? • Sub-PHS pricing – How does maintaining low PHS prices affect non-FAMP and FCP pricing calculations – Pros and cons of sub-ceiling pricing • Using allocation programs to ensure equitable and appropriate distribution of products • Estimating your PHS price for new drugs • Prime vendor program • Rebate arrangements with AIDS Drug Assistance Programs and compliance with 340B price controls • Navigating the process for the resolution of overcharge claims by covered entities and claims by manufacturers alleging duplicate discounting or the unauthorized resale or transfer of covered outpatient drugs • Status of the GAO report on the 340B program • Litigation update • What effect will Tricare data from 2008 being pushed on manufacturers have on annual non-FAMP reporting
|
| 5:30 |
Conference Adjourns to Day 2 |
Day 3 - Wednesday, April 30, 2014
| 8:00 |
Registration and Continental Breakfast |
| 8:50 |
Opening Remarks from Conference Chair |
| 9:00 |
Medicare Part D: Fundamentals, Updates, and Operationalizing the Coverage Gap Discount ProgramMelissa K. Bianchi • 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 • Identifying critical dates for Part D participation • Rebate contracting strategies under Part D • Assessing new opportunities and pitfalls from the closing of the Coverage Gap over time • Preparing for potential new mandates imposed by the Independent Payment Advisory Board • Taking advantage of revolutionary changes from plan star ratings • Potential legislative changes to require Medicaid-level rebates in Part D • Overview of PPACA legislation and CMS program design • Validating TPA CGDP invoice amounts • Managing the logistics of payments to multiple plan sponsors • CGDP payment disputes • Conduct of CGDP audits • Restrictions on use of CGDP data • What are manufacturers’ appeal rights? • Interaction with “Outside of Medicare” Part D patient assistance programs • Quarter-by-quarter analysis of managing accruals for the coverage gap – Surprises – Lessons learned
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| 10:00 |
Understanding Opportunities and Pitfalls When Contracting with ACA Exchange Qualifi ed Health PlansRobert J. Hill • Exchange Qualifi ed Health Plan (QHP) Fundamentals – Essential Health Benefi t formulary requirements – QHP Premiums and Premium Tax Credits – Cost-Sharing Subsidies, Risk Adjustment, Reinsurance and Risk Corridors • QHP Marketplace and Enrollment – Real-world example of plan comparison and enrollment – Who is enrolling? In what plans? • Fraud and Abuse Issues – Are QHPs subject to the Anti-Kickback Statute? False Claims Act? Sebelius letter and subsequent developments – Implications for Manufacturer/Provider Coupons, Copay Assistance, Premium Assistance • Rebate Contracting for QHPs – Tailoring Rebate Terms/Conditions for QHPs – Legal Reporting/Disclosure issues; PBM Administrative Fees – Utilization Data requirements • Technical/Implementation Issues – 2014 and beyond – “Back-end” systems; SHOPs – Enrollment fraud? – Latest developments
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| 11:00 |
Morning Coffee Break |
| 11:15 |
Managing the Operational Challenges of Government Prices: How to Get From Policy to PracticeOperational Challenges • Sources of data for calculation of federal price values – How is data smoothed for AMP? – Earned date or paid date? – Is class of trade assignment an issue? – Adjustments to sales • Operational challenges presented by health care reform implementation – Systems configuration and maintenance in light of health care reform Accommodating the changes that will be necessary under health care reform – What will it cost companies to implement these system changes? • Data handling in federal price calculations – What is the structure of the calculation? – How is data validated? – What are the differences between AMP, non-FAMP, and ASP? – What will the OIG want to see? • Delivery of federal price values – What is up front and what is delivered on the back end? – Is an SPAP important? – Supplementals: why are they here? • What IT solutions exist for managing the enormous sets of data used in pricing? • How can companies who have merged marry two different pricing systems, if at all? Finance related challenges • Understanding the background and purpose for SOX • Defining key terminology • Making adjustments to gross and net revenue for Medicaid & Medicare rebates in light of health care reform • Developing effective internal controls (IC) and documentation of methodology to ensure SOX compliance • Have the systems used to process claims/calculate liability been updated & validated? • What controls have been automated?
|
| 12:15 |
Networking Luncheon |
| 1:30 |
Understanding Reimbursement Changes and Enforcement Initiatives Relevant to Generic DrugsLarri A. Short Susan Pilch • Update of CMS Developments –NADACs, FULS, and State Requirements Regarding Changes to FFS Medicaid Reimbursement Algorithms • Best practices to take away from new litigation over drug approval status and product drug set up in DDR – Louisiana – Other possible issues • What do new pricing statics mean for the AWP risk? – Will there be a continuing role for WAC and/or AWP?
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| 2:30 |
Networking Coffee Break |
| 2:45 |
Understanding the False Claims Act (FCA) and Ongoing Government Enforcement and Compliance EffortsKirsten Mayer Heidi A. Sorensen Wendy C. Goldstein False Claims Act (FCA) Cases – A Year in Review • Insulating yourself from FCA liability • What to do when no formal rule is in place • Drafting a letter to the agency • Dealing with gray areas complicated by the fact that there is currently no guidance – Bundling – 5I – Reconciling AMPs • What should you be doing with the fact that you are within the period of restating AMPs after health care reform kicked in • Minimizing exposure when making reasonable assumptions The Enforcement Roles of OIG and Other Agencies • Understanding the current environment for compliance and enforcement related to pricing issues • Identifying compliance guidance for pricing issues • Analyzing enforcement trends • Anatomy of a government investigation • Roles of CMS, OIG and DOJ • Responding to government investigations • Collateral consequences of investigations • State enforcement issues 4:15 Conference Concludes |
Day 4 - Thursday, May 1, 2014
| 9:00 |
Post-Conference WorkshopFederal Government Contracts and Pricing: FSS, VA, DOD and MoreMarci Anderson Maureen Regan • The Department of Veterans Affairs’ delegated authority to negotiate and administer GSA FSS pharmaceutical contracts • Determining the FSS price – Identifying the Most Favored Commercial Customer (MFC) price – Price adjustment clause – Price reduction clause – Economic price adjustment clause – Industrial funding fee • Defining FCP and its role in government pharmaceutical price discounts • Calculating non-FAMP (non-Federal Average Manufacturer Price) – What sales are included and excluded from the non-FAMP calculation? – Defining and identifying “nominal prices” • Examining the relationship between the price reduction clause and FCP • Dealing with pricing calculations for transferred drugs and new drugs • VA and DoD formularies – Getting products on VA & DoD formularies – Working with Veterans Integrated Service Networks (VISN) formularies – Recognizing the differences between the TRICARE formulary and VA and DoD formularies in a VA hospital setting • VA audit rights, record retention policies and penalties
9:00 a.m. – 1:00 p.m. (Registration begins at 8:30 a.m.) |