Day One - Tuesday, May 15, 2018
Summit Registration and Morning Coffee
SHARED PLENARY SESSIONS
Chairperson’s Welcome and Opening Remarks
KEYNOTE: VIEW FROM THE HILL; INSIGHT INTO THE PRESENT HEALTHCARE LANDSCAPE AND IT’S IMPLICATIONS ON THE 340B DRUG PRICING PROGRAM
- Explore the current state of the health reform debate in Washington, including policy changes that affect the pharmaceutical sector, hospitals, and pharmacies
- Gain insight into how 340B cuts impact the program for both hospitals and manufacturers
- Ensure forward 340B regulatory and compliance strategies are in alignment with current and upcoming policy
- Understand the tax bill implications and landscape for uninsured population
HRSA KEYNOTE ADDRESS ON KEY AREAS COVERED WITHIN THE 340B OPA GUIDANCE AND HRSA’S PROGRAM INTEGRITY GUIDING PRINCIPLES TO MAXIMIZE OVERSIGHT REACH AND MANAGE COMPLIANCE RISKS
HRSA is responsible for the oversight of the 340B drug program, and since the program has experienced significant growth over the years, so has scrutiny by members of Congress and the drug manufacturers that participate in the program. In response to this increase in scrutiny, HRSA has stepped up the frequency of its program integrity audits. This session will allow attendees to delve into the findings of these audits and uncover the ways in which manufacturers and covered entities are handling them, allowing attendees to mitigate risk and develop successful strategies moving forward.
- Uncover contract pharmacy and limited distribution networks pitfalls
- Discover how covered entities prevent or correct findings from audits
- Review the future outlook from HRSA on Audits and their thoughts on increased regulations
Networking and Refreshment Break
MULTI-STAKEHOLDER PANEL: FOLLOW THE DISPUTE AND UNCOVER TOP CHALLENGES FACED AND DEVELOP SOLUTIONS TO BETTER NAVIGATE AND COLLABORATE ON DISPUTES
Through this interactive session, lend to the flow of the dispute process. Attendees will have the opportunity to engage and watch a claim go from when it first is initiated all the way through to true ups and reimbursements. Attendees will have the opportunity to uncover what a claim looks like when its computed from each stakeholders view to better understand the process.
- Discuss the journey of a dispute to truly grasp each stakeholders’ perspective on the dispute process
- Hear from multiple stakeholders regarding top hurdles and lessons learned when dealing with disputes
- Uncover best practices to ensure strongholds are in place to ease the dispute process for covered entities, pharmacies, and manufacturers
- Discuss self-disclosure reporting, and what covered entities’ can do when finding themselves non-compliant
DISCUSS FUTURE IMPLICATIONS OF VALUE-BASED CONTRACTS ON 340B
- Explore the discussion around value-based contracts for 340B and what that implies for the future of contracting with 340B covered therapies
- Examine the regulatory hurdles associated with reporting requirements that could cause hurdles for entering into value-based contracts
- Discuss relationships between covered entities and manufacturers and best practices to collaborate on pricing and contracting
- Adapt standards around kickbacks and government pricing to capitalize on the potential of value-based agreements
Manufacturers’ 340B Summit Break Out
ADDRESSING & IDENTIFYING REVENUE LEAKAGE IN THE 340B PROGRAM
The 340B Program was put into place to lower the cost of healthcare and provide better care to those under covered entities. Due to the dynamic structure, one of the most challenging areas to manage is profit catch in managed care. It is critical pharmaceutical executives master the most common forms of revenue leakage from duplicate discounts to diverting treatments to inpatient, in order to mitigate risks of revenue loss.
- Understand and explore the main areas of revenue leakage in the 340B program
- Mechanically set 340B pricing as structured part of the process to make profit catch refund
- Utilize CMS data to see how to function and control loop process
- Calculate liability and improve accuracy and accountability
REGULATORY THINK TANK: IMPLICATIONS OF THE CIVIL MONETARY PENALTIES FINAL RULE AND IT’S IMPACT ON 340B
The Health Resources and Services Administration has begun implementing the program integrity provisions which were added to the 340B statute. With each revelation in legislature, compliance and management of the program is becoming progressively more difficult. Through a review of the regulations and where they stand this session will assist executives with staying abreast of forthcoming regulations.
- Understand both the civil monetary penalties (CMP) and administrative dispute resolution requirements (ADR)
- Examine the covered entity corrective action and manufacturer repayment process
- Insights on best practices to calculate duplicate discounts, managed care, and FFS
- Uncover the patient definition to mitigate risk and legal action
Networking and Refreshment Break
HOT TOPICS CONGRESSIONAL UPDATE: ENSURE PREPARDENESS FOR THE FUTURE
There is no question that there is a lot of movement and uncertainty on the hill on all things healthcare. With competing bills and an unclear vision on where CMS is headed on Part B drugs, it is imperative to examine congressional updates to ensure preparedness for the future. Manufacturers’ will have the opportunity to gain insights into the most critical congressional updates and the most pressing topics of 2018. Join a high-level discussion around topics including, but not limited to:
- Hospital outpatient perspective payment system department cuts
- Hearings on HRSA auditing covered entities and rule and regulations there
- Discussion around contract pharmacy changes
- Understand the spike in the reported volume of 340B discounts
STATE PANEL DISCUSSION: EXPLORE APPROVED STATE PLAN AMENDMENTS AND THE IMPACT ON 340B
As with many government programs, each state has individual procedures and processes in place when computing the implications of 340B. Under the rule, states had until April 1, 2017 to submit a new State Medicaid Plan amendment that complies with the requirement that Medicaid reimbursement for drugs be based on the Actual Acquisition Cost (AAC) of a 340B drug. As such, it is imperative to explore key parts of the regulations and how they are being implemented by different states. Through panel discussion pharma executive will have the opportunity to come together to explore state amendments to State reporting requirements and factors to mitigate State disputes.
- Explore similar trends states are looking into in order to reduce disputes
- Uncover unique approaches being implemented to prevent disputes
- Discuss ways multiple states gather data from pharmacy and covered entities
- Uncover state amendments and how states prefer to address disputes
- Examine preferred methods of communications
- Discuss the types of documents needed
- Further insightsto assist in addressing disputes with states
Cocktail and Networking Reception
Day Two - Wednesday, May 16, 2018
Chairperson’s Welcome and Review of Day One
LEGAL INSIGHTS AND CONSIDERATIONS AROUND COVERED ENTITY AUDITS
Through this session, gain key insights into covered entity audits. Allowing for continued education around the covered entity 340B process, certain pain points for covered entities, and continued findings during the audit process. By acknowledging and understanding the nuances that go into covered entity audits, manufacturers can create strategies to mitigate risk and collaborate better with 340B initatives.
BENCHMARK BEST PRACTICES TO ENSURE COLLABORATION WITH COVERED ENTITIES THROUGH THE AUDIT PROCESS FROM SELF-DISCLOSURE LETTERS TO GOOD FAITH INQUIRIES
As audits start to increase and regulations starts to tighten around 340B the program and reporting, both covered entities and manufacturers must work together to ensure collaboration and compliance to mitigate risk. With an increased focus on the 340B program and tightening budgets, many organizations look to third party consultants and vendors to assist with managing and producing good faith inquiries. However, such initiations can be looked at in a negative light when not handled correctly. It is imperative for manufacturers, and covered entities alike, to effectively manage good faith inquiries in order to mitigate risk and encourage collaboration. As part of this session we will discuss best practices and lessons learned:
- Assist covered entities with follow up’s and ensure corrective actions are taken to enhance self-reporting efforts.
- Discuss unique strategies to analyze data, identify material breaches and address concerns to make self-reporting a less daunting task for both parties involved.
- Explore methods for managing third party relationships to mitigate risk and safeguard compliance
- Define ways to utilize inquiries to ensure program compliance and two-way relationships with covered entities
CASE STUDY: EFFECTIVLY PREPARE FOR THE INCREASED INTEREST IN AUDITS
The significant growth of the 340B program and scrutiny regarding how the savings are being used by the covered entities is bringing more awareness to this valuable initiative. It is not only imperative, should an audit take place, but beneficial to manufacturers to take a close look at their 340B programs in order to certify compliance and be prepared should an audit take place.
- Develop strategies around items HRSA might look for to better position how your organization should prepare in case of an audit
- Ensure new launch products have 340B policies in place to proactively disclose to HRSA ensuring compliance from point of launch and reducing diversion.
- Explore vulnerability of existing products to proactively plan for HRSA audits
Networking and Refreshment Break
PANEL DISCUSSION: IMPLEMENTING NEW GUIDANCE ON PRICE CALCULATIONS & AVERAGE CEILING PRICE
On January 5, 2017, HRSA issued its Final Rule on manufacturer calculation of 340B Drug Ceiling Prices and its authority to assess Civil Monetary Penalties on manufacturers who knowingly overcharge 340B covered entity. Now, more than ever, manufacturers must ensure accuracy when calculating 340B drug prices. This session will provide attendees with a lesson on strategies for adopting reporting, contracting, and pricing processes to ensure compliance.
- Examine New PHS pricing regulations specific to Best Price and it’s impact on 340B
- Challenges around the AMP Rule and language regarding Best Price exclusion prices under the 340B program and what happens to sub-ceiling prices
- Uncover ways to work with covered entities to make sure you're receiving the right data
- Explore methods to more accurately figure measurement and minimize rebate liability
FIRESIDE CHAT: INTERNAL VS. EXTERNAL EXPLORE OPERATIONAL CHALLENGES & PROVEN APPROACHES TO BETTER ALIGN REFUND STRATEGIES
Without a doubt, refunds are a large part of the 340B program. Manufacturers work diligently to successfully calculate average ceiling price however, it is likely that the ceiling price will need to be restated long after a covered entity have purchased the product. Now, with covered entities more heavily involved in audits, there is an added equation to refunds. Through a high-level “think tank” discussion, manufacturers will uncover industry best practices and lessons learned in managing refunds.
- Develop best practices with the treatment of true-ups
- Deciding the timing of refunds
- Look at process to accrue refunds
- Approaches used to contact the covered entity
- Explore benefits and pitfalls around self-managing restatements vs contracting out
EXPLORE SPECIALTY PHARMACY, PAYER, AND PBM GOALS WITH 340B IT’S EFFECT ON MANUFACTURERS
Statutory changes, HRSA guidance, and most recently the Patient Protection and Affordable Care Act have allowed more facility types to become eligible for 340B discounts, allowing covered entities to contract with multiple pharmacies. The 340B space continues to be one of uncertainty with the repeal of the ACA and a new interest from private Insurers and PBMs who dominate the specialty pharmacy space, look to take part in the 340B landscape. Through a panel discussion with a contract pharmacy, private payer, and PBM, explore the future landscape of pharmacy stakeholders and 340B.
- Explore what rights covered entities have to acquire drugs that are dispense uniquely through specialty pharmacies
- Review the growing number of products with unique methods of distribution through specialty and the implications this will have on 340B and covered entities
- Understanding the landscape around Specialty Pharmacy/Contract Pharmacy
- Explore the private payer/PBM landscape and their interest in 340B
Close of Summit