Bruce Quinn

Bruce Quinn

Foley Hoag LLP

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Molecular Diagnostics Clinical Utility Strategy: A Six-part Framework

Payers and technology assessments currently evaluate diagnostic tests in terms of three categories of information. These are “analytical validity” (the performance features of the test), “clinical validity” (the correlation...more

9/22/2014 - Clinical Laboratories Clinical Trials Technology

The Future of Coverage and Payment for Personalized Medicine Diagnostics

The past decade has seen incredible progress for the scope and impact of personalized medicine. Just ten years ago, tamoxifen and trastuzumab were among the few drugs that were routinely paired with a companion diagnostic...more

8/6/2014 - FDA Healthcare Personalized Medicine Prescription Drugs

FDA Unveils Anticipated Draft Guidance for the Regulation of Laboratory-Developed Tests

On July 31, 2014, the Food and Drug Administration (FDA) provided Congress notice of its intent to issue draft guidance providing a risk-based framework for the regulation of laboratory developed tests (LDTs) under the...more

8/6/2014 - Clinical Laboratories Draft Guidance Enforcement Guidance FDA Medical Devices Risk Assessment

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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