Brian P. Carey

- Washington, D.C. , Boston

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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 advises a wide range of life sciences companies and health care providers on federal legal, regulatory and legislative policy matters impacting the commercialization of novel technologies.  Over the past two decades, his insight and knowledge of the life sciences sector has guided numerous biotechnology, medical device companies, health care providers through the regulatory pathways to successfully launch new technologies.

As a Co-Chair of the Life Sciences Coverage & Payment Group, Brian has deep experience with biopharma and medical technology companies on Medicare coverage and payment, and food and drug approval issues for innovative technologies. He regularly advocates on behalf of technology developers and medical trade associations before the U.S. Congress, U.S. Department of Health and Human Services, and federal agencies.  His insights help advise investors appreciate regulatory risk and opportunity for new technologies.

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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.

Honors

  • Honor, Massachusetts Supreme Judicial Court, 2019 Pro Bono Honor Roll (November 2020) 
  • Chambers USA: America's Leading Lawyers for Business (2020-2021)

Involvement

  • Board of Directors and Treasurer, Health Law Advocates
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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