Foundations in Healthcare Compliance for Life Sciences Companies

The Science of Compliance

In the ever-evolving life sciences industry, compliance is top-of-mind for investors, business leaders, the public and the government. This heightened awareness of having appropriate compliance operations in place has increased expectations on what compliance programs entail, how professionals should get trained and what resources are dedicated to making these programs successful.

With the growing importance of compliance for emerging life sciences companies, Goodwin and Berkeley Research Group are pleased to announce our inaugural Foundations in Healthcare Compliance series, where participants will learn from experienced lawyers and professionals about the various considerations when building and growing a compliance program in the life sciences industry.

This six-week series is designed for new compliance officers, in-house counsel or their delegates and investor clients seeking more information about compliance in the life sciences market. We will offer CLE credit for lawyer attendees and non-lawyer compliance certification (HCCA), if available.

All sessions are 12:00 PM – 1:30 PM EDT.

To request an invitation, please contact Marisa Sandler.

   Co-hosted by: 

    

Thursday, November 4

The Framework of Compliance
(Compliance Fundamentals/Building Your Compliance Program)*

The goal of this session is to understand why companies need compliance.

Topics covered:

  • Federal Sentencing Guidelines; DOJ 2020 Guidance on Effective Compliance Programs; State Compliance Mandates; Customer / Payor Requirements
  • Establishing cultural expectations
  • Identifying the value of compliance for a healthcare / life sciences organization
  • Understanding structural needs (named regarding compliance operations) compliance officer; compliance committee; functions; responsibilities; leveraging support from other functions; engaging the C-suite; finding outside legal & consulting resources; administrative policies 
  • Concepts for policy drafting

Speakers: Goodwin Partner Matt Wetzel, BRG Managing Director Ed Buthusiem and Senior Managing Consultant Briannon Tunstall

*1.5 Hours of CLE Credit approved for CA, NJ, NY, PA, IL and TX

Thursday, November 11

The Kickback and Transparency Laws*

The goal of this session is to understand the basics of the various healthcare fraud & abuse laws and why these form the basis of life sciences companies’ compliance programs 

Topics Covered:

  • The Laws: the Anti-Kickback Statute; Stark Law; False Claims Act; Travel Act; EKRA; Beneficiary Inducement Law; state all-payor laws; federal & state transparency requirements (Sunshine Act, state marketing laws, customer & payor requirements, CMS, and recent enforcement actions); drug pricing laws (high level)
  • The Players: key agencies (OIG, DOJ, CMS, States)
  • Lessons from settlement agreements, Advisory Opinions, and Fraud Alerts
  • Specific substantive areas, such as patient assistance, HCP interactions, and more

Speakers: Goodwin Partner Roger Cohen, BRG Director Alyson Wooten and Goodwin Associate Heath Ingram

*1.5 Hours of CLE Credit approved for CA, NJ, NY, PA, IL and TX

Thursday, November 18

The Current Enforcement Environment
(Updates on Enforcement and the AUSA’s View)*

We will provide an update on enforcement in the life sciences industry over the last few years, including an opportunity to connect with two former Assistant U.S. Attorneys about the role and value of compliance.

Speakers: Goodwin Partners William Jackson & Jim Gatta and BRG Managing Directors Heather Bates & Tom Brown

*1.5 Hours of CLE Credit approved for CA, NJ, NY, PA, IL and TX

Thursday, December 2

COMPLIANCE PROGRAM GROWTH – INTERNAL INVESTIGATIONS**

The goal of this session is to understand the nuts-and-bolts of an effective internal investigations and the important role they play in detecting, preventing and correcting compliance issues

Topics Covered:

  • Establishing a reporting hotline and process to review allegations of wrongdoing
  • Establishing a sequence of annual risk assessments (incl. discussion of OIG recommendations and COSO guidelines for enterprise risk in healthcare organizations)
  • Issues for emerging companies
  • The value of internal investigations for a compliance program
  • Establishing and maintaining a culture of compliance, ethics and integrity

 

Speakers: Goodwin Partners Annie Railton and William Harrington and BRG Managing Directors Eric Matrejek and Michael Pace

 

**1.5 Hours of CLE Credit pending for CA, NJ, NY, PA, IL and TX

Thursday, December 9

Cybersecurity & Data Privacy for Life Sciences Companies**

We will provide an update on cybersecurity and data privacy compliance in the life sciences industry including the role, value, and importance of a cybersecurity and data privacy compliance program.

Speakers: Goodwin Partner Boris Segalis and BRG Managing Director Tom Brown

**1.5 Hours of CLE Credit pending for CA, NJ, NY, PA, IL and TX

Thursday, December 16

Case Studies — Learning in Action — Applying Lessons Learned to Real Life Scenarios**

The goal is to review, analyze and propose compliance-based solutions to common and not-so-common compliance problems. Two case studies will be examined.

Speakers: Goodwin Partner Matt Wetzel, BRG Director of Business Development Shana Logue and Senior Managing Consultant Briannon Tunstall

**1.5 Hours of CLE Credit pending for CA, NJ, NY, PA, IL and TX