MN Wild

CLE & Events

Challenges, Uncertainty, and Reform in the Clinical Laboratory Industry

Date: Friday, December 11, 2015 8:00 AM to 9:00 AM
Venue: Presidents Room / Minnesota State Bar Association  Minneapolis, MN United States  Get Directions
Total Price: $30.00

**Please note that this program will be held at the MSBA office.**

Deadline to Register: Tuesday, December 8, 2015

The clinical laboratory industry is facing an unprecedented level of change and uncertainty.  A recently published proposed rule by CMS, pursuant to the Protecting Access to Medicare Act (PAMA), will drastically cut reimbursement rates for certain diagnostic tests and create burdensome reporting and tracking obligations for health care providers.  Simultaneously, the FDA has proposed to begin, for the first time, regulating laboratory developed tests as medical devices.  Our panel will explore the legal and policy issues related to PAMA, its implementation, its implications for providers, and its impact, and the FDA’s legal authority to regulate laboratory developed tests, expected legal challenges to the FDA’s jurisdiction, and legislative alternatives being considered.

Breakfast begins at 7:30 a.m., followed by the program from 8:00 - 9:00 a.m.  Special meal requests need to be received no later than Tuesday, December 8.


Eric Marshall, Senior Director, Leavitt Partners

Jesse Berg, Principal, Gray Plant Mooty

Paul Sheives, Vice President, Reimbursement & Regulatory Policy, American Clinical Laboratory Association

CLE Credits:

1.0 Standard CLE Credit approved | Event Code: 212961  


Health Law or Food Drug & Device Law Section Member:  $15.00
MSBA Member but not a member of either section:  $20.00
Non-MSBA Members:  $30.00
Law Students: Free
New Admittees (Attorneys Admitted to the Minnesota Bar after January 1, 2015):  Free

Join the Health Law or Food Drug & Device Law Section:   MSBA members who are not members of either section can join one or both and attend this CLE for FREE.  Click here to add a section to your membership and then contact Sue Bores to register for this meeting at no charge.

Remote Participation: 

Attendance by phone and webcast is available.  Please indicate that you will attend remotely when registering.  Instructions will be sent via e-mail on Thursday, December 10.

To register with a check, please mail in this registration form.

Need to cancel? Please see our cancellation policy.

Questions? Contact Sue Bores | 612-278-6325

No sessions have been associated with this event.