The Legal and Operational Foundations
of Healthcare Compliance: Three-Part Web Series

Overview

In this three-part web series, Craig B. Bleifer and Sharon R. Delshad will provide a foundational training on the legal and operational principles of building and managing healthcare compliance programs.  In addition to the foundational elements, they will also incorporate their perspectives on the OIG and DOJ’s expectations for Compliance in Life Sciences companies based on more recent guidance documents and settlements.

Craig and Sharon have both worked at and supported Life Sciences companies of all sizes.  They bring their balanced perspectives of supporting everything from pre-launch companies through more mature companies under Corporate Integrity Agreements.

Summary:

Part 1:  January 13, 2022: Understanding and Managing the Risks in Healthcare Compliance

  • Part 1A: Key Laws, Regulations and Guidance Documents Underlying Healthcare Compliance Programs
  • Part 1B: Overview of the Seven Elements of an Effective Compliance Program and Other Areas of Focus

SPONSORED BY:


January 20, 2022:

Building the Foundations of an Effective Compliance Program

Part 2A: Leadership and Cross-Functional Partnership

  • We’ll discuss:
    • The importance of establishing a top-down and bottom-up Culture-of-Compliance.
    • The members and scope of a Compliance Committee.
    • Reporting to Executive Leadership and the Board of Directors.
    • How to partner with other departments for resource allocation.
    • How Legal and Compliance partner together to support the business, whether or not the departments are within the same reporting structure. 

Part 2B: Risk Assessments and Annual Compliance Planning

  • We’ll discuss:
    • Why Risk Assessments and Planning should be your first step in developing or enhancing a Compliance Program.
    • The role Legal plays in Risk Assessments and Risk Strategy.
    • How to identify high risk business areas, using a RAMP process, and how to embed Compliance and Legal requirements into business strategies and initiatives.
    • Finally, we’ll also cover the importance of Risk Management as an ongoing process to meet more urgent company or industry needs.

Part 2C: Policies and Procedures Best Practices

  • We’ll discuss:
    • The importance of brevity, understandability, and retention when it comes to how policies are presented to employees, as reinforced by the June 2020 DOJ Guidance.
    • How to measure the effectiveness of policies and procedures.
    • Policy and procedure ownership, as well as cross-functional and trans-national harmonization.
    • Which policies and procedures should be prioritized for emerging companies.

January 27, 2022:

Building and Managing Compliance Programs

Part 3A: Maintaining the Rest of the 7 Elements of Compliance

  • Compliance Training and Communication Plans. Developing a training program for employees as well as third parties.  Applying principles of adult learning at any budget.  Tips for reducing training-fatigue.  Utilizing social media and technology for Compliance communications.
  • Resource Allocation in Managing a Risk-Based Monitoring and Auditing Plan. How to develop monitoring and auditing plans based on risks and available resources.
  • Investigations Better Practices. Establishing standard protocol for investigations. How to use reporting systems to maximize the data analytics of violations.  The importance of having harmonized protocols across functions, such as Legal and HR.
  • Developing and Tracking Corrective Action Plans. How to maintain fairness and consistency when assigning Corrective Action.  How a cross-functional Corrective Action Committee can create standards and transparency in Corrective Action Plans.  Tracking and reporting individual employee as well as company-wide Corrective Action Plans.

Part 3B: Beyond the 7 Elements – Managing a Broader Scope of Requirements

  • Compliance’s responsibilities go beyond what is outlined in the OIG and DOJ guidance documents to support the companies in following many other laws and regulations, as well as general business risks.  In this section, we’ll cover some of the more common areas that Compliance supports.
  • HCP Spend Transparency and Other Filings. Creating a process to ensure all data is timely collected and reported. Utilizing spend transparency data for audits and trend identifications.
  • Anti-Bribery / Anti-Corruption (ABAC). Utilizing a combination of internal and external resources to establish and expand an ABAC Program.  Considerations for ABAC auditing plans.
  • Enterprise Risk Management: The importance of Enterprise Risk Management and why the Compliance Department and Committee may be best suited to manage the ERM processes and the ensuing Executive Leadership and Board reporting.
  • Business Initiative Reviews. Who owns, advises, or is informed to ensure compliance in Needs Assessments, Fair Market Value (FMV), and other analyses of business initiatives?
  • Privacy. Identifying each company’s unique privacy risks.  The cross-functional ownership of privacy between Legal, IT, and Compliance.  Applying the 7 Elements of Compliance to a Privacy Program.
  • Legal Areas that Compliance May Support. Based on a company’s size, how Compliance may support materials review, pricing and reimbursement contracts, distribution licensing.

Who should attend:

Legal, regulatory affairs, medical affairs, internal audit, compliance and monitoring professionals at emerging and established life sciences companies looking to set up a program or brush up on the latest best practices and learn the latest enforcement trends, including member of the following departments:

  • Compliance and Ethics
  • Compliance & Monitoring
  • Legal Affairs
  • Risk Management
  • Internal Audit
  • Finance
  • Marketing Operations
  • Medical Affairs

This workshop will also benefit consultants, tech vendors and companies providing services to the above audience.



SPEAKERS


Sharon R. Delshad

Principal, Rebel Compliance


Sharon is a compliance consultant and attorney with over 10 years experience supporting life sciences companies as both an in-house Compliance Director and Big 4 consultant with EY and PwC. She is a compliance generalist who has worked in depth on all aspects of Healthcare Compliance. Sharon supports companies of all sizes and primarily supports them to build, enhance, and simplify their compliance programs.  Contact: LinkedIn.com/in/sharonregina


Craig Bleifer

PRINCIPAL, CRAIG B. BLEIFER LLC


Craig Bleifer is the principal of Craig B. Bleifer, LLC, a law and consulting practice focused on advising and counseling clients on healthcare industry topics.  He has also been appointed as Consultant to Akin Gump Stauss Hauer & Feld, LLP to support their national health care clients on legal matters, with the perspective and experience of a recent in-house General Counsel.  Craig is the former general counsel for Novo Nordisk, Inc., and previously was the general counsel for Daiichi Sankyo, Inc. Craig has over 20 years’ experience in the US and Global healthcare industry and nearly 30 years as an attorney.  He is the Past Chair, PhRMA Law Section Executive Committee, and Past Chair, Healthcare Institute of New Jersey.  He has been awarded General Counsel of the Year by NJBIZ, and was awarded In-House Legal Department of the Year by New Jersey Law Journal.  Contact: craig@CraigBleifer.com.