Carey

Brian P. Carey

Partner
Washington, DC

I guide biopharma, medtech, and healthcare clients through the regulatory reimbursement pathways to successfully commercialize new technologies. 

Brian has over two decades of experience advising a wide range of life sciences companies and healthcare providers on federal legal, regulatory and legislative policy matters impacting novel technologies. As a Co-Chair of the Life Sciences Coverage & Payment Group, he has deep experience with assisting biopharma and medical technology companies on complex Medicare coverage and payment issues, and related billing and compliance issues for innovative technologies.
 

Brian regularly advocates on behalf of innovative technology developers and medical trade associations before the U.S. Department of Health and Human Services, Centers for Medicare & Medicaid Services and U.S. Congress. His insights help investors appreciate regulatory risk and opportunity for new technologies.

In recent years, Brian has counseled leading clinical laboratory and molecular diagnostic companies on the evolving regulatory and reimbursement requirements for Laboratory Developed Tests (LDTs). In particular, he has extensive experience advising laboratories on coverage, coding and payment pathways under the Protecting Access to Medicare Act of 2014 (PAMA).

Brian’s extensive background in healthcare policy matters includes serving as a legislative aide to Senator Edward M. Kennedy. In that capacity, he worked in the Committee on healthcare, biotechnology, and food and drug legislation. Prior to Foley Hoag, Brian was an associate at Sullivan & Cromwell in New York and he was a judicial law clerk for the Honorable Edward F. Harrington of the United States District Court of Massachusetts. Brian splits his time between the firm's Washington, D.C. and Boston offices.

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

Bar and Court Admissions

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

Experience

  • Represented MDxHealth SA (Nasdaq/Euronext: MDXH), a foreign private issuer, in its acquisition of the OncoType DX Genomic Prostate Score business from Exact Sciences Corporation (Nasdaq: EXAS) for cash and equity consideration of up to $100 million, including a multi-year earn-out arrangement.
  • Enabled a pharmaceutical to obtain the first Medicare New Technology Add on Payment (NTAP) for an oral 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 the development of the 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.
  • Presdented 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 and Congress leading to the creation of a new payment methodology for therapeutic radiopharmaceuticals based on the Average Sales Price (ASP) methodology.
  • Advised numerous clinical laboratories on the local coverage process with Medicare Administrative Contractors. 
  • 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.

Publications

  • "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)
  • "Medicare Coverage of PET for Cervical Cancer," JOURNAL OF THE AMERICAN COLLEGE OF RADIOLOGY, VOL. 3 NO. 1 (January 2006)

Honors & Involvement

HONORS
  • The Best Lawyers in America (2023)
  • Honor, Massachusetts Supreme Judicial Court, 2019 Pro Bono Honor Roll (November 2020) 
  • Chambers USA: America's Leading Lawyers for Business (2020-2022)
INVOLVEMENT
  • Board of Directors and Treasurer, Health Law Advocates

Speaking Engagements

  • “Replacement Organs: Who Will They Cure and Who Will Pay?,” Cell & Gene Therapy Bioprocessing & Commercialization Conference (October 2020)
  • “State of the Union: Flashback: The Last 10 Years,” DxConference (October 2019)  
  • “PAMA Update and NCDs Implementation Conundrum,” Next Generation DX Summit (August 2019) 
  • “Proposed Legislation Changes Review & Discussion,” MIT NEWDIGS Paying for Cures Workshop (August 2019)
  • "After Trump’s Drug Pricing Blueprint: What Happens Next? A View from Washington," BIO International Convention (June 2019)
  • “Identifying Opportunities for Enabling Precision, Financing,” MIT NEWDIGS Paying for Cures Conference (February 2019)
  • 13th Diagnostic Reimbursement Conference (December 2018)
  • “Advancing Patient Access to the Benefits of Gene Therapy,” ASGCT Value Summit (September 2018)
  • “Launching Biosimilars in the US Market: Navigating the Regulatory and Reimbursement Environment,” 5th Annual Biosimilars and Biobetters Congress (April 2018)
  • “Health Innovation Coverage,” Harvard Business School MBA Innovating in Health Care course (February 2017)
  • “The Price is Right: Or is it? Dissecting Pricing and Reimbursement Issues for Biosimilars,” ACI’s 8th Biosimilars Annual Summit (June 2017)
  • “State of the Union for Molecular Diagnostic Reimbursement,” Diagnostic Conference: Personalized Medicine through Diagnostics (March 2017)
  • “Coding Update for 2017,” 10th Semi-Annual Diagnostic Coverage & Reimbursement Conference (December 2016)
  • "To Be or Not To Be: Advanced Diagnostic Laboratory Tests," Next Generation Dx Summit (August 2016)
  • “Reimbursement for Advanced Diagnostics: Challenges and Opportunities,” Institute of Medicine (April 2015)
  • “PAMA Clinical Lab Fee Schedule Reform: Timing and Key Issues,” The Diagnostic Conference (DXCON15) (March 2015)
  • "Implications of Clinical Laboratory Fee Schedule Reforms: Key Considerations," The Diagnostic Conference (DXCON14) (September 2014)
  • "Implementation of CLFS Reforms: Key Considerations," BIO-PMC-NVCA Roundtable (May 2014)
  • “Bringing the Views of “Payer Regulators” into Product Development to Align Label Outcomes and Safety with Patient Access,” DIA 49th Annual Meeting (June 2013)
  • "Mastering Legal, Regulatory and Compliance Issues Associated with LDTs," 2013 Executive War College (May 2013)
  • "The ACA, Delivery Reform and What Happens Next," Society of Nuclear Medicine Conference (June 2012)
  • "Affordable Care Act: Health Delivery Reforms Now and In the Future," Society of Nuclear Medicine Annual Meeting (June 2012)
  • "Healthcare Reform and its Impact on Personalized Medicine," MassBio Annual Meeting (March 2011  )
  • "Section 3113 Demonstration Project and MDX Payment Issues," The Diagnostic Conference – DxCon East (March 2011)
  • "Delivery Reform and Accountable Care Organizations (ACOs)," MassMEDIC's A New World Order for Health Care (March 2011)
  • "Where We Are and What is Still to Come," Medical Development Group's Health Care Reform (December 2010)
  • "Health Policy Issues in Targeted Oncology," The Angiogenesis Foundation's 8th Annual International M. Judah Folkman Conference (October 2010)
  • "Changing Regulatory Environment for Target Oncology: FDA and Comparative Effectiveness,” The Diagnostic Conference: Personalized Medicine through Diagnostics (September 2010)
  • "The Health Reform Debate: What should Life Sciences Sector Expect?," Life Sciences Alley Conference (September 2009)
  • "What Early Stage Companies Need to Know about Medicare," National Venture Capital Association Conference (March 2008)
  • "Quality Reporting and Pay for Performance: A View from Congress," High Country Nuclear Medicine Meeting (March 2007)
  • "What Early Stage Companies Need to Know about Medicare," National Venture Capital Association Conference (December 2006)
  • “What Early Stage Life Sciences Companies Need to Know About Medicare Coverage and Reimbursement," Mid-America Healthcare Investors Network Meeting (November 2006)
  • “Charting the Course through Medicare Part D," 6th Annual Medicare & Medicaid Symposium (May 2006)
  • "Evidence-Based Medicine – Key Trends and Lessons Learned from CMS," MassMEDIC Conference (April 2006)
  • "An Inside the Beltway Perspective on Medicare Part D Benefit," Pinsonault PBM Symposium (March 2006)