Bruce Quinn

Bruce Quinn

Foley Hoag LLP

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The FDASIA Health IT Report

On April 7, 2014, the Food and Drug Administration (FDA) released a report entitled “FDASIA Health IT Report: Proposed Strategy and Recommendations for a Risk-Based Framework” (the “Report”). The Report was mandated by...more

4/16/2014 - Data Protection FCC FDA FDASIA Technology

Summary of Clinical Laboratory Fee Schedule Reform Provisions in the Protecting Access to Medicare Act of 2014

On April 1, the Protecting Access to Medicare Act of 2014 was enacted into law (Pub. L. 113-93). Section 216, entitled Improving Medicare Policies for Clinical Diagnostic Laboratory Tests, modernizes the Medicare payment...more

4/4/2014 - CLFS Clinical Laboratories GAO Medicare OIG Pharmaceutical Protecting Access to Medicare Act

Is Medicare Zero for Three? Diagnostics Policy Proposals for CY2014

Introduction - Each July, the Medicare agency makes policy proposals for changes in reimbursement for services delivered by physicians, hospital outpatient centers, and independent laboratories. For CY2014, CMS...more

9/16/2013 - Clinical Laboratories CMS Fee Caps Fees Medicare Proposed Regulation

2013-2014: Evolving Challenges for Value-Priced LDTs

Introduction - In 2004, the Genomic Health Oncotype DX breast cancer molecular test was launched and within five years had substantially changed the standard of care for patients with early breast cancers. How has the...more

9/16/2013 - Biotechnology Cancer Clinical Laboratories Diagnostic Tests Medical Research Pharmaceutical

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