Judgment in the Cloud: The future of risk and regulation with James Lord, Google Cloud
Erik Schulwolf
Counsel Global Regulatory
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Overview
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Experience
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Credentials
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Insights and events
Erik Schulwolf’s practice is at the forefront of cutting-edge life sciences and health care advancements. Erik advises molecular diagnostic laboratories, manufacturers of diagnostic tests, and biopharmaceutical manufacturers on complex issues, from reimbursement to pricing issues to federal and state government strategies and compliance. He regularly advocates for his clients through approaches with federal and state agencies, including the Centers for Medicare & Medicaid Services and Medicare Administrative Contractors, along with assisting with outreach to and negotiations with private payers and drafting federal and state legislation. Erik has experience in reimbursement for molecular diagnostics, including under the federal Protections Access to Medicare Act (PAMA) and state biomarker coverage laws.
In addition to federal agency advocacy, Erik possesses deep knowledge and vast experience in state-level policy and government strategies on access and price issues, making him a leader in the industry.
Representative experience
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.*
Advised numerous clinical laboratories on the local coverage process with Medicare Administrative Contractors.*
Advised numerous molecular diagnostic laboratories on successful submissions for "Advanced Diagnostic Laboratory Test" pricing under the Protecting Access to Medicare Act.*
Advised clinical diagnostic laboratories in response to audits and recoupments by Medicare contractors.*
Advised a biopharmaceutical manufacturer regarding the drafting of state legislation and supporting materials to prohibit the use of prior authorization and step therapy for prescription drugs.*
*Matter handled prior to joining Hogan Lovells.
Credentials
Education
- J.D., Harvard Law School, cum laude, 2015
- B.A., Amherst College, magna cum laude, 2010
Bar admissions and qualifications
- Massachusetts
- District of Columbia
Publications
News
05 February 2025
News
Press releases
01 August 2024