Life Science Compliance Update

October 11, 2017

MedTech Europe Changes Ethical Code

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MedTech Europe represents the medical technology industries as a joint venture between EDMA and Eucomed and promotes a balanced policy environment that helps the medical technology industry meet Europe’s growing healthcare needs and expectations.

In 2015, MedTech Europe implemented a revised version of the 2008 Code of Ethical Business Practice to regulate interactions between members of the group and healthcare professionals. To help implement the code, in 2012, MedTech Europe created the Conference Vetting System. The Conference Vetting System attempted to address MedTech Europe members’ divergent interpretation of the Code and to reduce the risks associated to industry sponsorship of healthcare providers to third-party educational events.

The new MedTech Europe Code of Ethical Business Practice sets strict, clear and transparent rules for the industry’s relationship with Healthcare professionals (HCPs) and Healthcare Organizations (HCOs), including company-organized events, arrangements with consultants, research and financial support to medical education.

The Code of Ethical Business Practice has six big changes: (1) the phasing out of direct sponsorships; (2) transparency of educational grants; (3) creating a common chapter on general criteria for events; (4) creating a new chapter on demonstration products and samples; (5) agreed definitions; and (6) a common independent enforcement mechanism.

According to MedTech Europe, the new Code is a message from the medical technology industry to safeguard and protect the relationship with healthcare professionals by adopting clear and strict self-regulations.

The largest change coming from the new educational grant system is that it adds a significant amount of work onto the shoulders of the healthcare organization.

  1. Conferences supported by medical device companies will need to apply and be in compliance with the Ethical Vetting System;
  2. Healthcare organizations will need to write and submit grant requests to each medical device company that sponsors delegations to their medical meeting;
  3. Once awarded the grant, healthcare organizations will be responsible for choosing the healthcare providers that will receive support, following the guidelines as set forth on the grant requested;
  4. Healthcare organizations will be responsible for the management of the sponsored healthcare providers, including figuring out how to contact them, gather their information, manage their travel requirements, etc.; and
  5. Healthcare organizations and medical device companies will need to submit reconciliation and disclosure reports to MedTech Europe.

The rules will change in several ways, including: by forcing the public disclosure of grants, ensuring increased transparency of the funds allocated to medical education; by requiring conferences to comply with specific requirements and the Conference Vetting System; by allowing grants to be provided only to legal entities and never individuals, requiring a written contract and other related documentation; by allowing companies to define the types of recipients eligible for the grants; and by requiring companies to have internal and independent processes based on objective criteria to assess grant requests.

While most of the changes will affect European meetings, the most important change for the United States medical meeting industry is that MedTech Europe member companies will not be able to directly sponsor a healthcare provider, neither as a delegate nor as a speaker.

As of 2018, MedTech Europe will require all meetings to be vetted through its Conference Vetting System, and only these meetings will be eligible to receive funds from MedTech Europe member companies — and only through educational grants.

Healthcare organizations should brace themselves for an impact and will need to plan for a loss in revenue from any international delegations sponsored by Medical Technology Companies in Europe.

October 02, 2017

Webinar: Risks and Opportunities in Today’s Changing World of Continuing Medical Education

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On Tuesday, October 31, 2017, our editor Thomas Sullivan will be a host of “Risks and Opportunities in Today’s Changing World of Continuing Medical Education,” a webinar. The webinar will discuss ways to take advantage of the unique opportunities presented in today’s healthcare environment and how you can minimize the risks to your Continuing Medical Education (CME) office.

Participants in the webinar will: gain perspective on the changing federal healthcare environment in the United States, including an overview of applicable rules and regulations; learn what the new Centers for Medicare and Medicaid Services (CMS) rules for CME and performance improvement/quality improvement will mean, and how to prepare for the 2018 implementation; discuss the challenges with new and proposed state policies; understand the new policy of MedTech Europe that will prohibit medical device companies from directly funding European physician travel to U.S.-based meetings, and the implications it may have on their activities; and learn about the American Academy of Family Physicians’ new blended learning format option, and how to incorporate it into your educational programming to provide a more effective learning process.

In addition to Mr. Sullivan, the webinar will feature viewpoints from Andy Rosenberg, Senior Advisor for the CME Coalition and Amy Smith, Senior Manager of CME Credit Systems and Compliance for the American Academy of Family Physicians.

If you are interested in participating, please register here.

September 29, 2017

Webinar: Trump or Trumped – Update on CME and Federal Policy

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On October 25, 2017, Andrew Rosenberg at Thorn Run Partners and Thomas Sullivan, our editor and President of Rockpointe Corporation, will present a webinar on CME and federal policy. The webinar will be hosted by the Alliance for Continuing Education in the Health Professions (ACEHP).

The webinar will focus on the various health reform plans that continue to swirl around Washington, D.C., and what they may mean for continuing medical education (CME). Some of the topics to be discussed during the webinar include: the Affordable Care Act (ACA) versus current Republican proposals; reviewing the Open Payment policy and CME changes, including where they may be leading; and evaluating the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) and the role CME will play in its success.

The webinar will take place from 2:00 pm – 3:00 pm EST on October 25, 2017. If you are interested, please register here. If you have any questions, you can contact acehp@acehp.org.

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