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Gain exclusive and unparalleled access to an in-depth guide on navigating the legal and regulatory maze of prescription drug pricing and rebates.

Week 1

Drug Pricing and Rebate Essentials and Introduction to Medicaid

Monday, November 1 • 1:00pm–4:30pm EST

1:00pmAnalysis of the National Rebate Agreement and the Mechanics of the Rx Drug Rebate System

The Medicaid Drug Rebate Program (MDRP) is a program that includes Centers for Medicare & Medicaid Services (CMS), state Medicaid agencies, and participating drug manufacturers that helps to offset the Federal and state costs of most outpatient prescription drugs dispensed to Medicaid patients.…
The program requires a drug manufacturer to enter into, and have in effect, a national rebate agreement with the Secretary of the Department of Health and Human Services (HHS) in exchange for state Medicaid coverage of most of the manufacturer’s drugs.…

Manufacturers are required to report all covered outpatient drugs under their labeler code to the MDRP. Manufacturers may not be selective in reporting their National Drug Code’s (NDC) to the program. Manufacturers are then responsible for paying a rebate on those drugs for which payment was made under the state plan. These rebates are paid by drug manufacturers on a quarterly basis to states and are shared between the states and the Federal government to offset the overall cost of prescription drugs under the Medicaid Program.

In addition to signing a national rebate agreement, drug manufacturers are required to enter into agreements with two other Federal programs in order to have their drugs covered under Medicaid: a pricing agreement for the Section 340B Drug Pricing Program, administered by the Health Resources and Services Administration, and a master agreement with the Secretary of Veterans Affairs for the Federal Supply Schedule.

Medicaid Drug Rebate Program, cms.gov
The National Rebate Agreement
  • Understanding the agreement’s terms and purpose
  • What is required to participate in the agreement?
  • Why is participation in the Medicaid outpatient drug program contingent on participation in the PHS 340B and VA programs?
  • How is the PHS program linked to Medicaid?
  • What relation does the agreement have to the Medicare Drug benefit?
    (i.e., Medicare Part D)
Mechanics of the Rx Drug Rebate System
  • Survey of applicable drug pricing legislation such as the MMA, DRA, and ACA
  • Overview of Medicaid, Medicare, and PHS Programs relative to prescription drug coverage
  • How is price established?
  • How does the rebate system work?
  • Under which of the payor systems are rebates available?
    • Medicare
    • Medicaid
    • PHS
    • VA
    • DOD

2:10pmAWP (Average Wholesale Price) and WAC (Wholesale Acquisition Cost): What You Need to Know

  • How is AWP calculated?
  • When is AWP still used?
  • What is included in WAC, and when?
  • Defining the relationship between AWP and WAC
    • what are their roles in the calculation of Medicaid Rebates?

2:30pmBreak

3:00pmMedicaid Pricing and Rebate 1.0: Key Terminology

  • Analysis of the Medicaid rebate system’s components:
    • reimbursements v. volume discounts
      • what are they?
      • when is each used?
      • to whom are they given?
  • Medicaid Rebate terminology: Best Price; AMP
    • defining “retail community pharmacy” class of trade (COT) for AMP calculations
  • Best Price: what is it and how is it calculated?
    • how are the calculations different for generic products?
  • AMP: what is it and how is it calculated?
    • what are the variables in AMP price calculation?
  • URA: what is it and how is it calculated?
  • Status of additional rebate under CPIU
  • Is there a nominal price exception to the reporting requirements under Medicaid?
    • how is this exception determined?
  • What is the overall effect of nominal pricing on the rebate system?

4:00pmRecap and Q & A

4:30pmEnd of Monday Session

Trevor Wear

Trevor Wear

Partner

Sidley Austin LLP

Elizabeth Lindquist

Elizabeth Lindquist

Partner

King and Spalding LLP

Merle DeLancey

Merle DeLancey

Partner

Blank Rome LLP

Drug Pricing and Rebate Essentials and Introduction to Medicaid

Wednesday, November 3 • 1:00pm–4:30pm EST

1:00pmMedicaid Pricing and Rebate 2.0: Complexities and Challenges

  • Validating transactional data
    • Ensuring the completeness of direct sales, indirect sales, price concession (rebates, discounts, etc.), fee, returns, and adjustment data
  • Analyzing 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
    • Invoice adjustments: Returns, price corrections and order corrections
  • Understanding what constitutes a bundle arrangement and developing an unbundling methodology
  • 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
    • Accounting for the entry of authorized generics and biosimilars

1:45pmAnalysis of Key Aspects of CMS’ Finalized MDRP Rule

The panel will analyze developments coming out of the CMS’ MDRP rule that was finalized in December 2020. Highlights will include the background for these proposals, the challenges which they present, and how the rule could affect price reporting and business operations.

Among the topics covered will be:

  • PBM accumulator programs
  • Impact on price reporting for MA Plans
  • Value-based purchasing arrangements
    • Reporting multiple BPs
  • Line extensions, and Authorized generics

2:45pmBreak

3:15pmAnalysis of State Drug Transparency Laws

This session will explore the rise of state transparency laws across the country and how they are working in conjunction with government payor programs.

  • Manufacturer notifications and justifications requirements from the manufacturer
  • Enforcement and actions taken under existing laws
  • Addressing challenges with and finding solutions for reporting under non-uniform and sometimes conflicting state laws
    • Can a state request supplemental rebates within these models?
    • If the rebate is denied, can the state exclude the drug from Medicaid coverage?
  • Developing a system to keep track of these laws as well as a compliance program to address them
  • Impact of transparency laws on Medicaid pricing

4:00pmRecap and Q & A

4:30pmEnd of Wednesday Session

Melissa Wong

Melissa Wong

Partner

Holland & Knight LLP

Trevor Wear

Trevor Wear

Partner

Sidley Austin LLP

Trevor Wear

Christopher H. Schott

Partner

Latham and Watkins LLP

Merle DeLancey

Merle DeLancey

Partner

Blank Rome LLP

Elizabeth Lindquist

Elizabeth Lindquist

Partner

King and Spalding LLP

Week 2

Medicare Pricing and Rebate Essentials

Monday, November 8 • 1:00pm–4:30pm EST

1:00pmMedicare Part B: Coverages and Rebate and Pricing Essentials

  • Identifying drug coverages under Medicare Part B
  • 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?
    • Impact of COVID relief fund provisions on reporting
  • Bundling
  • Special concerns for radiopharmaceuticals
  • Reimbursement under Part B
    • Most Favored National Model
  • Reimbursement of generic specialty drugs
  • Biosimilars

2:15pmBreak

2:45pmMedicare Part D: Coverages and Rebate Pricing Essentials

  • Identifying coverages under Part D
  • Understanding the mechanics of Part D
    • 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
  • Reviewing Part D fraud and abuse concerns
  • Examining Part D formulary requirements
  • Developing rebate contracting strategies under Part D
  • Taking advantage of plan Star Ratings
  • Accounting for specialty pharmaceuticals
  • Assessing 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

4:00pmRecap and Q & A

4:30pmEnd of Monday Session

Andrew Ruskin

Andrew Ruskin

Partner

K&L Gates LLP

Kristin Hicks

Kristin Hicks

Partner

Arnold & Porter LLP

Stephanie Trunk

Stephanie Trunk

Partner

Arent Fox LLP

Partha Chatterjee

Partha Chatterjee

Partner

Akara Group LLC

VA and DoD Rx Pricing and Rebates

Wednesday, November 10 • 1:00pm–4:30pm EST

1:00pm A Guide to the Essentials of FSS Contracting for Pharmaceuticals with the VA and DOD

  • Examining overall obligations when contracting with the federal government with respect to:

    » General Services Administration (GSA) Federal Supply Schedule (FSS): what are the requirements?
    » VA (Veteran’s Affairs)/ DOD (Department of Defense)
    » Tricare
    » PHS – 340B
    • Understanding the significance of bifurcated tracks and when they are used
    • How is non-FAMP (non-Federal Average Manufacturer Price) calculated?
    » how do you calculate the FSS price from non-FAMP?
    » which entities are eligible?

2:00pmBreak

2:30pm Advanced VA and DoD Pricing and Contracting

  • Reviewing criteria for a drug to be eligible for consideration under the FSS
    • 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
  • Understanding 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 considerations and challenges
    • Comparative pricing
  • Understanding the differences in the processes used by the VA National Acquisition Center and Defense Logistics A

4:00pmRecap and Q & A

4:30pmEnd of Wednesday Session

T. Reed Stephens

T. Reed Stephens

Partner

Winston & Strawn LLP

Ted Karnezis

Ted Karnezis

Owner

Karnezis Consulting LLP

Merle DeLancey

Merle DeLancey

Partner

Blank Rome LLP

Joy Sturm

Joy Sturm

Partner

Hogan Lovells LLP

Week 3

PHS 340 B Pricing and Rebates

Monday, November 15 • 1:00pm–4:30pm EST

1:00pmPHS 340B 1.0 – Introduction to the 340B Program and the Link to Medicaid Rebate

  • What is a PHS 340B entity and why do they receive special pricing on drugs?
  • PHS 602: navigating the complexities of determining who qualifies for 340B
  • What steps does a 340B entity need to take to qualify for the program’s benefits?
  • Discounts to wholesalers – how do they affect Best Price/AWP within the 340B context?
  • Re-packaging and re-labeling: understanding how they affect pricing in the context of 340B
  • Understanding how bundling, tying, and GPO arrangements impact 340B
  • When do orphan drugs qualify for a 340B discounting arrangement?

2:00pmPHS 340B 2.0

  • Examining continuing reimbursement cuts to 340B hospitals and understanding how this impacts manufacturers
  • Analyzing important amendments to PHS 340B under the CMP final rule and how they affected pricing and rebates
    • Penny pricing
    • Distribution systems
    • Calculation of the 340B price
  • Validating the eligibility of purchasers
  • Developing 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 provisions
  • Exploring HRSA’s limited authority to enforce the 340B program
    • Examining manufacturers’ obligation, or lack thereof, to offer 340B pricing on drugs dispensed by contract pharmacies
      • Implications of recent cases
  • Protecting against duplicate discounts
    • Analyzing claims data
  • Assessing the pros and cons of turning 340B into a rebate program
  • Examining current trends and updates on recent developments and whether agency guidance is enforceable
  • Evaluating the likelihood of future government audits of covered entities
  • Contract pharmacy

3:15pmBreak

3:30pmLAB — Learn, Apply, and Benchmark:
Pricing and Rebate Exercise Under Medicaid, Medicare, and 340B

This hands-on session will draw from hypothetical examples to show how the pricing and reimbursement concepts you have just learned about fit together in the real world.

4:30pmEnd of Monday Session

T. Reed Stephens

T. Reed Stephens

Partner

Winston & Strawn LLP

Jennifer Lospinoso

Jennifer Lospinoso

Managing Director & Consulting Lead

Riparian LLC

James Kim

James Kim

Partner

McDermott, Will & Emory LLP

Joseph Metro

Joseph Metro

Partner

Reed Smith LLP

Christopher H. Schott

Christopher H. Schott

Partner

Latham and Watkins LLP

Advanced CMS Pricing and RebateTopics

Wednesday, November 17 • 1:00pm–4:30pm EST

1:00pmUnderstanding How Co-Pay Coupons, Accelerators, and Maximizers Impact Medicaid and Medicare Pricing and Rebates

  • Defining coupons, accelerators and maximizers and examining their similarities and differences
    • How are the parameters for such discount mechanisms set?
  • Reviewing these mechanisms as a whole and understanding how they are affecting Medicare and Medicaid pricing
    • In what ways do these mechanisms impact out of pocket expenses?
    • How do they relate to the Medicare “donut hole”?
  • How do these mechanisms affect patients in the public payor realm
  • Exploring the process for working with a coupon vendor
  • What are the types of pharmaceuticals and biologics sold under these mechanisms?
  • How do these mechanisms s effect specialty products?
  • Reviewing recent litigation surrounding the use of co-pay coupons
  • Examining the HHS blueprint as to whether coupons are considered a discount
    • Can the removal of safe harbors be considered in the future relative to these mechanisms?

2:00pmBreak

2:30pmViews from the Hill: The Latest Proposals on Drug Pricing and Reporting and What They May Signify

The panel will analyze the status of the previous administration’s Executive Orders aimed at addressing drug prices and price reporting and what to expect under Biden. This panel will explore where proposals have landed and the implications for manufacturers.

  • Eliminating “kickbacks” to middlemen
  • Improving access to affordable life-saving medications
  • Tying drug prices to international benchmarks
  • Increasing drug importation, implications for Medicaid, 340b programs

3:30pmMedicaid/Medicare Recap and Q & A

4:30pmEnd of Wednesday Session

Andrew Ruskin

Andrew Ruskin

Partner

K&L Gates LLP

Trevor Wear

Trevor Wear

Partner

Sidley Austin LLP

Stephanie Trunk

Stephanie Trunk

Partner

Arent Fox LLP

James Kim

James Kim

Partner

McDermott, Will & Emory LLP

Week 4

Pricing and Reimbursement for New Products and Therapies

Monday, November 29 • 1:00pm–4:30pm EST

1:00pmWill Your Product Be Eligible for Reimbursement?: Pre-Commercialization Concerns in New Therapeutic Development

New considerations:
  • Understanding the distinction between FDA approval and commercial viability
  • Planning to secure appropriate coding, coverage and reimbursement for new products
  • Assessing the competition landscape and articulating a compelling value composition
Questions to ask now:
  • When should you start talking to payors about coding, coverage and reimbursement?
  • What are the limitations on discussing coding, coverage, and reimbursement with prescribers?
  • How can you stay compliant when marketing a new product in light of those restrictions?
  • What types of products are drug, biotech, and biopharmaceutical companies seeking to develop now and why?
  • What regulatory and commercial impediments are preventing these companies from pursuing the development of the desired product?
  • Will the product/technology be covered through government payor/pricing methodologies?

2:15pmBreak

2:45pmNew Product Launch – Government Pricing and Contracting Considerations

  • Identifying the steps generally involved in setting a launch price for a new drug
  • Understanding the role of the pricing committee and other key stakeholders
  • Understanding legal, policy, and reputational risks around price setting
  • Exploring the uses of list prices versus other pricing metrics in supply chain agreements
  • What is the role of pricing in connection with drug reimbursement under the Medicaid Drug Rebate Program, Medicare Program, 340B program, and the VA/FSS?

4:00pmRecap and Q & A

4:30pmEnd of Monday Session

Keren Tenenbaum

Keren Tenenbaum

General Counsel, Vice President of Legal & Compliance US

Vifor Pharma

Margaux Hall

Margaux Hall

Partner

Ropes and Gray LLP

Erica Petersohn

Erica Petersohn

Sr. Manager, Life Sciences Consulting
Government Pricing & Contacting Solutions Leader

Baker Tilly U.S.

Pricing and Reimbursement for New Products and Therapies

Wednesday, December 1 • 1:00pm–4:30pm EST

1:00pmValue of Therapy to Value Proposition: Sources and Uses of Pricing Data in Prescription Drug Advertising and Promotion

  • Understanding key variables in the determination of value to key stakeholders
  • What is a value proposition?
  • Identifying databases of pharmaceutical benchmark prices for economic analyses
  • Communicating why your medical product is worth paying for in quantitative terms

2:30pmBreak

3:00pmDelving Deeper into Critical Drug Pricing-Related Pre-Launch Considerations

This session will delve into pre-launch drug pricing related considerations that can either help smooth the path to a successful launch or cause ongoing chalrations (e.g., approval pathway, special designations, or patient populations)

  • Method and setting of administration
  • Unit of measure/dosage form
  • Billing codes
  • Payor program (dis)alignment, including formulary and prior authorization considerations as part of market access strategy
  • Targeted patient population
  • Likely customer type(s) and channel partners and types of common pricing arrangements with these partners

4:00pmRecap and Q & A

4:30pmEnd of Wednesday Session and Series

Nneka Onwudiwe

Nneka Onwudiwe

Former PRO/PE Regulatory Review Officer

U.S. Food and Drug Administration

Margaux Hall

Margaux Hall

Partner

Ropes and Gray LLP

Craig-Bleifer

Craig Bleifer

Principal

Craig B. Bleifer, LLC