Value Based Rx Contracting Tactics and Techniques: Navigating Legal and Regulatory Complexities

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Value Based Rx Contracting Tactics and Techniques: Navigating Legal and Regulatory Complexities 
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Value-based pharmaceutical contracts, sometimes referred to as risk sharing agreements between pharmaceutical manufacturers and health plans or other purchasers are critical in today’s very complex and costly healthcare marketplace. These agreements allow placement of high-risk, high-cost and often times specialty pharmaceutical products onto purchaser formularies through basing payment on outcomes as opposed to volume metrics. The concept has become popular in single payor systems, and is beginning to take flight in the U.S. as evidenced by several high profile value based contracts between pharmaceutical manufacturers and health plans. However, as with every new concept in the U.S. health care arena, there are growing pains, fear and uncertainty.

Tactics and techniques in developing and executing successful value based pharmaceutical contracts start with assessing value and defining risk from both the pharmaceutical manufacturer and purchaser perspectives, and specifying the role of applicable third party data assessors in value determinations. Contract terms must be negotiated within the risk definition and risk tolerance of both parties. The targeted outcomes, and the processes in determining and documenting them, need to be fully examined, including: the consequences of failing to meet the outcome and any payment increase for proven value;  the development of criteria for demonstrating outcomes and value of product; the timeframes involved and responsibility for evaluation of results; and determination of the parties to be responsible for data collection and  and the procedures involved.

In order to establish a value-based contract, pharmaceutical manufacturers as well as purchasers must understand the complexity of these agreements and the legal implications associated with it. Manufacturers will need to ensure safe harbor protection under the Anti-Kickback Statute to enter qualified value based contracts. As there is a greater exchange of more data between stakeholders, manufacturers must mitigate HIPAA risks including reporting of adverse events and sharing of patient data. They must also understand the legal regulations necessary to take into account within value based contracts.

Special concerns must be addressed in pharmaceutical value based agreements with non-traditional purchasers such as hospitals, hospital systems, integrated delivery networks (IDNs) and ACOs. These challenges include rebates and government programs, and incorporating provisions in regard to these agreements to compliantly address
best price calculations.

Please join us Thursday, September 14, 2017 at 1 PM Eastern as Sidley Austin's William A. Sarraille discusses trends; alternative structures; legal and compliance issues;  network features, benefits and disadvantages; and current examples around the country in the HealthcareWebSummit event: Value Based Rx Contracting Tactics and Techniques: Navigating Legal and Regulatory Complexities.
Learning Objectives

After attending this webinar, attendees will be able to:

  1. Explore various tactics and techniques to be applied in developing and executing successful value based pharmaceutical contracts.
  2. Examine considerations in determination and documentation of targeted outcomes, and the processes involved.
  3. Understand the anti-kickback statute and discount safe harbors as they apply to value based contracts
  4. Identify patient privacy regulations to consider when establishing value-based contracts
  5. Evaluate HIPAA risks related to the collection and sharing of patient level data and reporting of adverse events
  6. Discuss the basis for government price reporting and how it affects contract considerations.
  7. Engage in interactive learning through online question submission, attendee feedback and opportunity for follow up questions, and networking with attendees, faculty and other professionals through dedicated LinkedIn group.
Who Should Attend

Interested attendees would include:

  • C-Suite Executives
  • Legal, Regulatory and Compliance Executives and Staff
  • Contracting Executives and Staff
  • Value and Outcomes Based Payment Executives and Staff
  • Pharmaceutical benefit Executives and Staff
  • Managed Market Executives and Staff
  • Planning and Strategic Executives and Staff
  • Business Intelligence Staff
  • Other Interested Parties

Attendees would represent organizations including:

  • Life Science Organizations
  • Health Plans
  • PBMs
  • Third Party Adminsitrators
  • Employers
  • Hospitals and Health Systems
  • Accountable Care Organizations
  • Provider Networks
  • Government
  • Consulting Organizations
  • Solutions Providers
  • Associations, Institutes and Research Organizations
  • Media
  • Other Interested Organizations
Value Based Rx Contracting Tactics and Techniques: Navigating Legal and Regulatory Complexities
  Individual Registration Fee: $195. Post-event materials, with video syncing slides and recorded audio, plus presentation pdf file: $45 for attendees; $260 for non-attendees after the event. Register online or download the event brochure. Attendees will also receive a free subscription to the semi-monthly Managed Markets e-newsletter.
Register Now   Corporate Site licensing also available. Click here to register or call 209.577.4888 We look forward to your participation in this event!
William A. Sarraille

William A. Sarraille
Sidley Austin, LLP

  Bill Sarraille is a senior member of the Healthcare practice group and a nationally-recognized lawyer in healthcare law. Bill concentrates on a variety of healthcare matters, including Medicare and Medicaid reimbursement, coverage and coding, pharmaceutical price reporting, issues related to the marketing and promotion of pharmaceuticals and medical devices, internal investigations, clinical research issues, Stark and Anti-Kickback Law analyses, Medicare and Medicaid audits, healthcare acquisitions and due diligence, compliance program audits, managed care matters, healthcare contracts, administrative litigation, legislative matters, privacy and security, coverage for new devices and services, the Foreign Corrupt Practices Act, international compliance and healthcare contracting, the representation of witnesses and companies before Congressional Committees, and the defense of healthcare criminal and False Claims Act matters. Bill has defended clients in some of the largest healthcare fraud investigations brought by the U.S. Government.

Bill’s clients have included pharmaceutical companies, biotechnology companies, device and equipment manufacturers, diagnostics manufacturers, academic medical centers, hospitals, health systems, faculty practice plans, durable medical equipment suppliers, healthcare consulting firms, ambulatory surgical centers, physician practice management companies, managed service organizations, managed care organizations, large physician group practices, imaging centers, financial institutions, contract research organizations, and leading healthcare trade associations and professional societies.

Bill is consistently recognized as a leading healthcare lawyer in Chambers USA and LMG Life Sciences. He was named an LMG Life Sciences star in 2013, 2014 and 2015, and has been recognized every year since 2013 in Chambers USA as a leading lawyer both in D.C. and nationwide. Chambers notes that sources describe Bill as a "terrific regulatory healthcare lawyer" with a "wide range of experience” and noted he is “an excellent reimbursement lawyer.” The directory has also described him as “‘an intellectual heavyweight. He is hugely professional on every issue.’” It also listed Bill as “a very good communicator and a trusted adviser.” Recognized in the 2016 edition of Who’s Who Legal: Life Sciences, they noted “He superbly handles all the regulatory issues encountered by his clients.”

Washingtonian magazine includes Bill on its 2013 list of Washington’s Best Lawyers as one of the region’s “best legal minds” in the area of Healthcare Law. He was listed by Nightingale’s Healthcare News as one of ten “Outstanding Practice Lawyers for 2006.” He is the co-author of several books on healthcare. Bill served on the Regulatory Relief Committee for the American Hospital Association and served on the Compliance Advisory Committee for the Healthcare Financial Management Association as its Chairman. He served as a law clerk to the Honorable Harry L. Hupp in the U.S. District Court for the Central District of California in Los Angeles following his graduation from Harvard Law School in 1989.
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