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Physician Payment Sunshine Act--How to Avoid Sunburn this Summer!

Date: Wednesday, June 11, 2014 8:00 AM to 9:30 AM
Venue: Oppenheimer Wolff & Donnelly LLP  Minneapolis, MN United States  Get Directions
Total Price: $30.00


Deadline to Register:  Friday, June 6, 2014

Later this year medical device, drug and biologics executives will be required to attest to the accuracy of their respective sunshine data before submitting it to CMS.  Questions that these executives should be thinking about before attesting to the accuracy and completeness of the data submitted include:

           Are my data sets correct?

           Are my data sets in violation of applicable laws or our own internal policies?

           Are we monitoring compliance and violations?

           How will our customers react if we submit wrong information?

Sunshine violations are the tip of the iceberg.  Company executives should also be asking whether the data they submit to CMS exposes them to state violations, the Anti-Kickback Statute and/or the False Claims Act.  If companies have elected to follow PhRMA or AdvaMed will their data submission reflect that choice?

Program Description
This Physician Payment Sunshine Act (“Sunshine Act”) CLE will cover the following:

           Phase 1 and 2 Open Payments reporting and registration

           Three levels of sunshine reporting (general payments, research and ownership & investment interests)

           What to report/what can be skipped

           Developing a policy

           Educating on the policy

           Data collection and reporting

           Monitoring adherence to policies

           Mitigating risk

           Data validation

           Avoiding reporting disputes


CMS reserves the right to audit companies for compliance and uses the word “audit” twenty times in the Final Rule of the Sunshine Act.  Undoubtedly, government litigators will be trolling the CMS database containing all payment information disclosed, which will be made public September 30, 2014, for suspect payments and other information about companies.  Many others will also be interested in this data, including other government agencies (IRS), media, consumer advocacy groups and competitors.  Fines are $1000-$100,000 per violation.  Companies must ascertain how and what they will report and when they can lawfully avoid reporting. 

Mark Gardner, M.B.A., J.D., DuVal & Associates, P.A.
Mark Gardner, M.B.A., J.D., is an Associate Attorney at DuVal & Associates, P.A., a law firm dedicated to counseling companies in the medical device, pharmaceutical, biotech, food, and nutritional supplement industries. Mark’s areas of expertise include FDA regulation; state and federal sunshine laws; FDA enforcement actions; health care fraud and compliance under the Anti-Kickback Statute, Stark, the False Claims Act, and HIPAA; design and implementation of regulatory compliance programs; and promotional review and marketing strategy.  Prior to his legal career Mark worked in sales and product management at three medical device companies over a 10-year span focusing on commercializing and developing products and services in the interventional, wound care, diagnostic and laboratory spaces.  Mark teaches FDA law and is the Health Law Regulatory Compliance Competition Coach at Hamline University School of Law.  He Co-Chairs the Regulatory Special Interest Group at LifeScience Alley and is Chairman of the Minnesota State Bar Association’s Food, Drug and Device Law Section.   

Michael Sullivan, M.B.A., Vector Health Inc.
Michael Sullivan is a Director of Client Services at Vector Health, a provider of Commercial Operations and Compliance technology and consulting solutions for pharmaceutical and medical device manufacturers. In his current role, Marc oversees the identification and implementation of strategic market initiatives.  Prior to position with Vector Health, Michael was Director of Practice Support at Mayo Clinic Health System in Mankato.  In that position, he managed internal physician disputes, compensation and recruitment. Michael has been involved in several ventures serving the operational needs of the Pharma/Device industry including SEI Program Services and Medicom Digital.  Lastly, Michael has held field and management positions at Pfizer, Merck-Schering Plough, and Kadmon pharmaceuticals.  Michael holds an undergraduate degree from Minnesota State University Moorhead and MBA from the University of St. Thomas.

CLE Credits:
1.5 Standard CLE credits will be approved | Event Code:   191316

Remote Participation:
Teleconferencing is available.  Please indicate that you will attend remotely when registering.  Instructions will be sent via e-mail on Tuesday, June 10.


Food Drug & Device Law Section Member:  $20.00
MSBA Member But Not A Food Drug & Device Law Section Member:  $25.00
Non-MSBA Members:  $30.00
Law Students:  Free


Join the Food Drug & Device Law Section:  $28.00  MSBA members who are not members of the Food Drug & Device Law Section can join the section & attend this event for FREE.  Pay the 12-month section dues and your section membership will expire on June 30, 2015.  Click here to add the Food Drug & Device Law Section to your membership and then contact Sue Bores to register for this meeting at no charge.

Non-attorneys who are not eligible for membership in the MSBA can join the Food Drug & Device Law Section.  Details are available here. 

Credit card payments should be made online:


To pay by check, use the registration form located here.


Need to cancel?  Please see our cancellation policy.


Questions?  Contact:
Sue Bores l l 612-278-6325

No sessions have been associated with this event.