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Challenges, Uncertainty, and Reform in the Clinical Laboratory Industry

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Summary:

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.

Product Description:

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