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
•
Auditing
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.
Presenters:
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.
Cost:
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:
http://msba.mnbar.org/Meetings/Meeting?ID=428
To
pay by check, use the registration form located here.
Need
to cancel? Please see our cancellation policy.
Questions?
Contact:
Sue Bores l sbores@mnbar.org l
612-278-6325