Panoramic: Automotive and Mobility 2025
Brian Carey
Partner Global Regulatory
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Overview
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Experience
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Credentials
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Insights and events
For over two decades, Brian Carey has advised biopharma, medical device and diagnostic companies on complex regulatory and legislative health policy matters, omplex Medicare coverage, payment, and compliance matters. Brian’s experience advocating before the U.S. Department of Health and Human Services, Centers for Medicare & Medicaid Services, and U.S. Congress provides his clients with the confidence and insights to anticipate regulatory risk and seize opportunities to accelerate the adoption of innovative technologies.
He has extensive experience helping biopharma manufacturers to navigate coverage and payment issues for novel product areas such as cell and gene therapies and innovative drug delivery devices. He has guided numerous companies to prepare for commercial launch in the United States, and regularly works with HL counterparts on product launches in Europe and Asia.
Brian regularly counsels innovative medical technology developers, medical trade associations, leading clinical laboratories, and molecular diagnostic companies through the evolving regulatory requirements to commercialize new technologies successfully. His practice focuses on addressing regulatory challenges for Laboratory Developed Tests, assessing payment under the Protecting Access to Medicare Act of 2014 (PAMA), and establishing coverage pathways with public and private payers.
Brian also advises venture capital and private equity investors on assessing the reimbursement framework for medical technologies as part of investment and transactional due diligence reviews. Brian is able to use his years of experience to translate complex regulatory requirements into specific opportunities and challenges.
Representative experience
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 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.*
Presented 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 methodology.*
Advised numerous clinical laboratories on the local coverage process with Medicare Administrative Contractors.*
*Matter handled prior to joining Hogan Lovells.
Credentials
Education
- J.D., Boston College Law School, magna cum laude, 1997
- B.S.E., Wharton School of Business, Philadelphia, 1992
- B.A., University of Pennsylvania, 1992
Bar admissions and qualifications
- Massachusetts
- New York
- District of Columbia
Court admissions
- U.S. Court of Appeals, First Circuit
- U.S. District Court, Southern District of New York
- U.S. District Court, District of Massachusetts
Recognition
News
Press releases
01 August 2024
Events
Hogan Lovells Events
12 - 14 January 2026
Hogan Lovells Events
25 September 2025 | 3:45 p.m. - 7:00 p.m.