Brian P. Carey

Partner, Co-Chair, Administrative Law Department - Washington, D.C., Boston

Brian Carey
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Contact Information

Washington, D.C.
202.261.7398

Boston
617.832.1712

617.832.7000

bcarey@foleyhoag.com Download vCard

Brian Carey’s legal practice focuses on advising a wide range of clients on federal legislative and regulatory issues impacting the life sciences and health care sectors. He primarily advises biotechnology, medical device companies, health care providers, medical trade associations and private equity investors. Brian previously served as a co-chair of the firm's Administrative Law practice group.

His work with biopharma and medical technology companies includes advice on Medicare coverage and payment, and food and drug approval issues for innovative technologies. He regularly represents clients in matters before the Congress, Department of Health and Human Services, and federal agencies.

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Education:

  • Boston College Law School, J.D., magna cum laude, 1997
  • Wharton School of Business, B.S.E., 1992
  • University of Pennsylvania, B.A., 1992

Representative Experience

  • Enabled a pharmaceutical to obtain the first ever Medicare New Technology Add on Payment (NTAP) for an oral anti-biotic therapy.
  • Helped CMS design and create one of the first data registries in its Coverage with Evidence Development (CED) program, by advising a coalition of leading academic medical centers and medical device manufacturers.
  • Advised leading molecular diagnostic company on current Medicare coverage, payment, and coding challenges on the Clinical Laboratory Fee Schedule (CLFS).
  • Developed novel legal arguments and assembled compelling scientific evidence that successfully reversed an adverse policy decision affecting the coding and payment for biotechnology product.
  • Developed legal arguments for a new medical technology that led to the creation of a new DRG for an inpatient hospital payment.
  • Represented a biotechnology client before CMS leading to the creation of a new payment methodology for therapeutic radiopharmaceuticals based on the Average Sales Price (ASP) methodology.
  • Worked with the Center for Medicare and Medicaid Innovation (CMMI) on an innovative payment and service delivery model to improve quality of care for federal health care beneficiaries.
  • Co-author, "The National Oncologic PET Registry: Expanded Medicare Coverage for PET Under Coverage with Evidence Development," AMERICAN JOURNAL OF ROENTGENOLGY, VOL. 188 NO. 4 (April 2007)
  • Co-author, "Medicare Coverage of PET for Cervical Cancer," JOURNAL OF THE AMERICAN COLLEGE OF RADIOLOGY, VOL. 3 NO. 1 (January 2006)

Foley Hoag Alerts & Updates

Involvement

  • Board of Directors and Treasurer, Health Law Advocates
  • Next Generation DX Summit, 8th Annual Coverage and Reimbursement for Advanced Diagnostics: “PAMA Update and NCDs Implementation Conundrum,” August 2019 
  • MIT NEWDIGS Paying for Cures Workshop: “Proposed Legislation Changes Review & Discussion,” August  2019 
  • BIO 2019: "After Trump’s Drug Pricing Blueprint: What Happens Next? A View from Washington," June 2019
  • MIT NEWDIGS Paying for Cures Conference: “Identifying Opportunities for Enabling Precision, Financing,” February 2019
  • 13th Diagnostic Reimbursement Conference: Moderator, December 2018
  • ASGCT Value Summit: “Advancing Patient Access to the Benefits of Gene Therapy,” September 2018
  • 5th Annual Biosimilars and Biobetters Congress: “Launching Biosimilars in the US Market: Navigating the Regulatory and Reimbursement Environment,” London, April 2018
  • HBS MBA Innovating in Health Care course: “Health Innovation Coverage,” February 2017
  • ACI’s 8th Biosimilars Annual Summit: “The Price is Right: Or is it? Dissecting Pricing and Reimbursement Issues for Biosimilars,” June 2017
  • NEWDIGS Financing and Reimbursement of Cures in the U.S. (FoCUS) Design Lab, April 2017
  • Diagnostic Conference: Personalized Medicine through Diagnostics, “State of the Union for Molecular Diagnostic Reimbursement,” March 2017
  • 10th Semi-Annual Diagnostic Coverage & Reimbursement Conference: “Coding Update for 2017,” December 2016
  • Next Generation Dx Summit: "To Be or Not To Be: Advanced Diagnostic Laboratory Tests," August 2016
  • Institute of Medicine: “Reimbursement for Advanced Diagnostics: Challenges and Opportunities,” April 2015
  • The Diagnostic Conference (DXCON15): “PAMA Clinical Lab Fee Schedule Reform: Timing and Key Issues,” March 2015
  • The Diagnostic Conference (DXCON14): "Implications of Clinical Laboratory Fee Schedule Reforms: Key Considerations," September 2014
  • BIO-PMC-NVCA Roundtable: "Implementation of CLFS Reforms: Key Considerations," May 2014
  • DIA 2013 49th Annual Meeting: “Bringing the Views of “Payer Regulators” into Product Development to Align Label Outcomes and Safety with Patient Access,” June 2013
  • 2013 Executive War College: "Mastering Legal, Regulatory and Compliance Issues Associated with LDTs," May 2013
  • Society of Nuclear Medicine Conference: "The ACA, Delivery Reform and What Happens Next," June 2012
  • 2012 Society of Nuclear Medicine Annual Meeting: "Affordable Care Act: Health Delivery Reforms Now and In the Future," June 2012   
  • 2011 MassBio Annual Meeting: "Healthcare Reform and its Impact on Personalized Medicine," March 2011  
  • The Diagnostic Conference-DXconlleast: "Section 3113 Demonstration Project and MDX Payment Issues," March 2011
  • MassMEDIC's - A New World Order for Health Care: "Delivery Reform and Accountable Care Organizations (ACOs)," March 2011
  • Medical Development Group's Health Care Reform: "Where we are and What is Still to Come," December 2010
  • The Angiogenesis Foundation's 8th Annual International M. Judah Folkman Conference Antiangiogenesis: New Frontiers in Therapeutic Development, "Health Policy Issues in Targeted Oncology," October 2010
  • The Diagnostic Conference: Personalized Medicine through Diagnostics, "Changing Regulatory Environment for Target Oncology: FDA and Comparative Effectiveness", September 2010
  • Life Sciences Alley Conference: "The Health Reform Debate: What should Life Sciences Sector Expect?," September 2009
  • National Venture Capital Association Conference: "What Early Stage Companies Need to Know about Medicare," March 2008
  • High Country Nuclear Medicine Meeting: "Quality Reporting and Pay for Performance: A View from Congress," March 2007
  • National Venture Capital Association Conference: "What Early Stage Companies Need to Know about Medicare," Palo Alto, December 2006
  • Mass Biotech Council's 8th Annual Investor Conference -- MASS Opportunities: "A Biotechnology Investment Conference," November 2006
  • Mid-America Healthcare Investors Network Meeting:"What Early Stage Life Sciences Companies Need to Know About Medicare Coverage and Reimbursement," November 2006
  • The 6th Annual Medicare & Medicaid Symposium: "Charting the Course through Medicare Part D," May 2006
  • Mass MEDIC Conference: "Evidence-Based Medicine – Key Trends and Lessons Learned from CMS," April 2006
  • The Pinsonault PBM Symposium: "An Inside the Beltway Perspective on Medicare Part D Benefit," March 2006
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Bar Admissions

  • Massachusetts
  • New York
  • District of Columbia

Court Admissions

  • U.S. Court of Appeals First Circuit
  • U.S. District Court for the Southern District of New York
  • U.S. District Court for the District of Massachusetts