Legal & Global Compliance

No matter the size or sector, all medical technology companies must address critical legal, health care and global compliance issues.

Below are just a few of the Legal & Health Care/Global Compliance sessions that were offered at The MedTech Conference in 2019. The 2020 conference program will be available early this summer.

View the 2019 full conference program

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AdvaMed’s New Code of Ethics: Is Your Company Prepared to Comply?

AdvaMed recently released its updated Code of Ethics on Interactions with Health Care Professionals, which will take effect on January 1, 2020. The updated Code introduces four new topics critical for medical technology companies: Jointly Conducted Education and Marketing Programs, Communicating for the Safe & Effective Use of Medical Technology, Consigned Products and Company Representatives Providing Technical Support in the Clinical Setting.

Will your company need to adopt new policies to reflect the Code’s new sections, notably those relating to communications, technical support and joint programs? Are your company’s Industry codes in compliance? This discussion featured industry experts that offered practical tips to get into compliance with only a quarter of the year left to prepare.

Health Care Fraud: The Government View and the Compliance Perspective

In the last several years, government scrutiny of the health care industry has significantly increased, with 2018 bringing the largest health care enforcement action in the Department of Justice’s history. Medical device and pharmaceutical manufacturers, health care providers, insurers, and other players in the industry have been paying close attention and ramping up compliance efforts to ensure they are not the subject of the next big enforcement action.

This panel brought together current and former prosecutors to discuss hot topics at the intersection of government enforcement and industry compliance. Speakers included the acting chief of the nation’s most active enforcement authority in health care cases, who covered the government’s enforcement priorities in the health care industry — from drug pricing and reimbursement to opioid diversion.

Attendees also heard unique insights of former prosecutors who now handle compliance for health care organizations. They discussed the issues keeping them up at night and how their organizations are responding, and provided practical advice that attendees can apply to their own compliance function.

Everyone Knows Health Care Is DOJ’s Favorite Target; What Does That Mean for MedTech Executives?

Unfortunately, it’s become abundantly clear that health care has become DOJ’s favorite target. Recent policy pronouncements and enforcement trends indicate an important shift to the ways in which companies, their management, and their board members need to handle investigations and compliance. This panel explored very recent DOJ enforcement rulings, trends and policy pronouncements with the goal of providing valuable take-away lessons/information that addressed best practices for companies, executives and board member intent on avoiding, if not surviving, a DOJ investigation.