Brought to you by

Sr. Director, HCP Compliance Maritz Travel, A Maritz Global Events Company

PAT SCHAUMANN, CMP, CSEP, DMCP, HMCC

ETHICS, TRANSPARENCY AND

COMPLIANCE IN HEALTHCARE

DISCLAIMER

THIS PRESENTATION DOES NOT

CONSTITUTE LEGAL GUIDANCE. IT WAS

PREPARED AS A SERVICE TO OUR

PARTICIPANTS AND IS INTENDED TO BE AN

INSTRUCTIONAL SUMMARY.

WHY IS THIS SO HARD?

1. Laws

2. Internal company compliance

3. Corporate Integrity Agreement (CIA)

4. Industry Association – PhRMA, AdvaMed, EFPIA, etc.

5. US State Exceptions

6. Military Physician regulations

7. Government

8. Cross-border Compliance

MANY MASTERS

COMPLIANCE:

Certification or confirmation that the doer of the action or the medical

drug or device manufacturer/supplier meets the requirements of

accepted practices, legislation, prescribed rules and regulations,

specified standards or the terms of a contract.

TYPES OF OVERSIGHT/REGULATION

Transparency

Rules

Standards

Policies

Regulations

Law

Requirements

Compliance

PROMOTE TRANSPARENCY BY

PUBLISHING FINANCIAL RELATIONSHIPS

BETWEEN THE MEDICAL INDUSTRY AND

HCPS.

CATEGORIES

Education

Research

Charitable contributions

Royalty or license

Ownership or investment

interest

Compensation for serving as

speaker for an accredited or

certified continuing education

program

Grant

Venue rental fees (teaching

hospitals only)

1.Encourage transparency of reporting financial ties.

2.Prevent inappropriate influence on research, education, and

clinical decision-making.

3.Avoid conflicts of interest that can compromise clinical integrity

and patient care.

4.BETTER PATIENT CARE!

U.S. – Covered Recipients, and Applicable

Manufacturers

Connecticut and Minnesota, Nevada, Chicago,

New Jersey – stay tuned

Europe – Member Industries, HCPs, and HCOs

CONQUERING GLOBAL SOURCING

CONFUSED? TOP CHALLENGES OF PLANNING

MEDICAL MEETINGS

Short lead time

Making changes on-site by staff without approval

Suppliers lacking knowledge of industry

Constantly changing laws and regulations

Trained staff

Understanding of industry issues by procurement,

compliance department and compliance attorneys

Privacy

MY COMPLIANCE WIZARD

www.mycompliancewizard.com

GUIDE YOUR “CLIENT”

Set reasonable expectations upfront.

Make sure you are doing everything

possible to ensure that they make the

right decisions regarding compliance

and transparency.

ASK THE RIGHT QUESTIONS

Examples of key compliance-related questions to start with:

Who is sponsoring or paying for the meeting?

Who are the attendees and where are they from?

Are there any compliant meeting caps that will impact the

budget/planning?

Are there other guidelines/laws/regulations/codes that may govern the

meeting?

What data is required for reporting?

– Individual or aggregate?

CMS’ OPEN PAYMENTS 2017 REPORTING RESULTS

Applicable manufactures and Group Purchasing

Organizations collectively reported $8.40 billion in payments in

2017.

This amount is comprised of 11.54 million total records

attributable to 628,214 physicians and 1,158 teaching

hospitals.

NEW CHANGES AFFECTING MEDICAL MEETING

MANAGEMENT

KEY CHALLENGES: PRIVACY (EU)

Disclosure Code Privacy

Code Breaches

Industry Reputation

Criminal Prosecution

Relationship with HCP

Legal Obligation

HOW WILL THIS NEW REGULATION AFFECT MEDICAL MEETINGS?

GDPR: GENERAL DATA PROTECTION REGULATION

WHAT DOES IT MEAN?

Adopted by the European nations in 2016 and

effective May 25, 2018, this regulation is the EU’s

attempt to provide better protection for EU citizens,

and to allow them more control over their personal

information.

The regulation affects any events that involve

collection of personal data from an EU citizen who

attends events anywhere in the world.

SEVEN KEY REQUIREMENTS

1.

Consent

2.

Breach Notification

3.

Access

4.

Right to be Forgotten

5.

Data Portability

6.

Privacy by Design

7.

Data Protection Officer

PERSONAL DATA

What is personal data? What is not personal data?

A name or address of clients,

prospective clients, suppliers,

participants, employees and

candidates for job

Credit card information

IP address

Participants’ food habits, allergies,

etc.

A video of an event with no

identifiable persons

A folder in intranet with only

financial information

A statistical data, under conditions

The information regarding a legal

person

WHAT DOES THIS

MEAN TO YOUR

COMPANY?

Global Impact

Refers to any organization dealing

with data relating to person

located in the European Union

WHAT CAN WE EXPECT?

California Consumer Privacy Act of 2018

– Like the GDPR, this new legislation spells out rights for protection of the privacy of California consumers.

– Mashed together in less than a week

– Goes into effect January 1, 2020

FACTS,

TRENDS

AND

CHANGES

HOW WILL EUROPE’SNEW MEDTECH CODE

AFFECT YOUR MEETINGS?

WHAT IS CHANGING?

Once upon a time, member companies of MedTech Europe

— which started as a partnership between the medical-

technology trade organization Eucomed and the European

Diagnostic Manufacturers Association (EDMA) in 2012 —

could directly sponsor specific health-care providers (HCPs) to

support their trip to a third-party organized event such as a

medical meeting. But the Code of Ethical Business Practice

will do away with that.

THE MEDTECH EUROPE CODE OF ETHICAL BUSINESS

PRACTICE – THE CHANGE

The change calls for the discontinuation of direct

sponsorship of HCP’s

Independent medical education has to be supported

exclusively by means of Educational Grants.

Such Educational Grants can be provided to

Healthcare Organizations (HCOs) or Professional

Congress Organizers (PCOs or third-party meeting

planning organizations).

WHAT IS ACCME’S GUIDANCE FOR CME PROVIDERS

RELATEDTO REVISED INDUSTRY CODES?

What is their position on standards for commercial support that have

been introduced by MedTech Europe, AdvaMed, and APACMed,

organizations that represent the device manufacturing industry.

Expectations

Alignment between the revised codes and ACCME requirements

The main changes brought by the new code are:

1. The phasing out of the direct sponsorship

2. New transparency for educational grants

3. A common chapter on general criteria for events

4. A chapter on demonstration products and samples

5. Agreed definitions

6. A common independent enforcement mechanism

WHAT?

HOW DOES THE DIRECT

SPONSORSHIP BAN AFFECT YOU?

Member companies will not be able to provide financial or in-kind support

directly to individual healthcare professionals to cover the costs of their

attendance at third-party organized educational events.

Third-party educational events are interpreted broadly as including activities

of any type planned, budgeted, managed and executed in whole (or in

part) by another entity (other than the member company) to fulfill

healthcare professional medical educational needs. In practice, this

includes all third-party organized educational conferences such as national,

regional or specialty medical association conferences, educational

conferences organized by hospitals, conferences organized by professional

conference organizers, by accredited continuing medical education

providers and by patient organizations.

WHAT IS THE APPLICABILITY TO NON-MEMBER

COMPANIES?

Non-member companies may implement

these Disclosure Guidelines provided they

are committed to ethical standards

equivalent to those enshrined in the Code.

Non-member companies may prove this

commitment by obtaining the MedTech

Europe Ethical Business logo.

Resources

MedTech Europe Code’s Procedural Framework

http://www.medtecheurope.org/node/576

Resource section

http://www.medtrecheurope.org/node/1073

Code Hotline

ethics@medtecheurope.org

ACCME

info@acme.org

OTHER COUNTRY, STATE, CITY CHANGES? New Jersey

Chicago

Nevada

Vermont, Massachusetts, Minnesota, Washington,

DC, West Virginia, California, Connecticut,

Louisiana

• Stay educated – HMCC,

CMP-HC, industry

conferences, webinars

• Train your team

• Know the best resources

for updates

HOW TO KEEP

CURRENT

TOOLS

– Open Payments User Guide

– My Compliance Wizard – www.mycw.info

– MedTech Europe

– EFPIA web site

– “Breaking the Code to Healthcare Compliance”, 4th Edition

– http://www.meetingcompliance.com

Explore Open Payments DataFIND YOUR DOCTORS’ PAYMENTS

https://openpaymentsdata.cms.gov

QUESTIONS

Facts, Trends and Changes The Economist Intelligence Unit has predicted that more than 70% of

pharmaceutical sales this year will be made in countries with transparency

regulations.

The FDA is beginning to issue rules on usage of social media by

manufacturers.

Thank You!Please complete the

session evaluation in

the mobile app by

selecting the

clipboard icon on

the red toolbar with

the session page.