Challenges, Uncertainty, and Reform in the Clinical Laboratory Industry

Minnesota State Bar Association, Minneapolis

Speaking Engagement

Join Gray Plant Mooty's Jesse Berg for a CLE session sponsored by the Minnesota State Bar Association

From the MSBA: 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.


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