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.
This CLE is available until
February 24, 2018.
Presenters:
Eric Marshall,
Senior Director, Leavitt Partners
Jesse Berg, Principal, Gray Plant
Mooty
Paul Sheives, Vice President, Reimbursement & Regulatory Policy,
American Clinical Laboratory Association
CLE
Credit:
1.0 Standard CLE credits
approved | Event Code:
216552
Cost:
MSBA Members: $29.95
Non-MSBA Members:
$64.95