Stuart Kurlander

Stuart Kurlander

Latham & Watkins LLP

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FDA to Strengthen Oversight of Certain In Vitro Diagnostic Devices

In the wake of a new Medicare reimbursement framework, FDA plans stricter regulation of some in vitro diagnostic devices. On July 31, 2014, the U.S. Food and Drug Administration (FDA; Agency) announced its intent to...more

8/21/2014 - CLIA Clinical Laboratories CMS FDA Healthcare Medical Devices Medicare Reimbursements

Applicable Manufacturers Face June 30th Deadline for Sunshine Act Reporting

CMS will begin to enforce what could be significant penalties on manufacturers who fail to report required data. The Centers for Medicare & Medicaid Services (CMS) has announced a short timeframe before detailed...more

6/12/2014 - CMS Deadlines GPOs Healthcare Manufacturers Medical Devices Prescription Drugs Reporting Requirements Sunshine Act Transparency

10 Tips for Medical Technology Companies

The Centers for Medicare & Medicaid Services (CMS) has initiated a new review process of existing national coverage determinations (NCDs). This new process is designed to retire old policies and may present increased risks to...more

10/24/2013 - Biotechnology CMS Healthcare Medical Devices Medicare

10 Strategic Considerations for Tackling Medicare’s Revised National Coverage Determination Process

CMS’s August 2013 notice establishes a new internal review process, signalling increased agency-initiated activity - The Centers for Medicare & Medicaid Services (CMS or the Agency) has initiated an automatic,...more

10/18/2013 - CMS Employee Benefits Internal Investigations Medicare

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