Hertzog

Erin Estey Hertzog

Partner
Co-Chair, Healthcare Department
Washington, DC

I provide strategic advice to healthcare and life sciences companies on legal and policy issues related to system delivery reform and payment for innovative technologies. 

Erin Estey Hertzog serves as a co-chair of the firm's Healthcare Department. She advises clients regarding system delivery reform and value-based payment models; coding, coverage, payment, and drug pricing issues for innovative new technologies; and legal and regulatory issues before the U.S. Department of Health & Human Services (HHS) Office of the General Counsel. Since its enactment in 2022, Erin has also gained a reputation as a leading authority on the Drug Price Negotiation provisions of the Inflation Reduction Act. 

Erin joined Foley Hoag from the CMS Division of the HHS Office of the General Counsel, where she was the lead attorney for the Center for Medicare and Medicaid Innovation (CMMI). While at HHS, Erin’s views on CMMI’s authority were widely viewed as authoritative, informing healthcare transformation and the expenditure of billions of appropriated dollars. In advising on dozens of CMMI’s innovative payment and service-delivery models, Erin also achieved extensive expertise in drafting value-based arrangements, Medicare and Medicaid coverage and reimbursement, the Administrative Procedure Act, and data privacy.  
 
Prior to joining HHS, Erin served as the Director of Health Law and Policy at the Biotechnology Industry Organization (BIO). While at BIO, Erin worked with member companies from across the biotechnology industry to craft the industry's response to legislative and regulatory proposals on Medicare and Medicaid coverage and payment, alternative payment models, and government price reporting programs. She also gained a nationwide reputation as a leading expert on the 340B Drug Pricing Program. 

Education

  • George Washington University Law School, J.D., with highest honors, Order of the Coif, 2009
  • George Washington University, M.P.H., 2009
  • Colby College, B.A., magna cum laude, Phi Beta Kappa, 2003

Bar and Court Admissions

BAR ADMISSIONS
  • District of Columbia

Languages

  • Spanish

Experience

  • Assist clients in navigating the Medicare Drug Price Negotiation Program established by the IRA.
  • Advise clients drafting value-based arrangements for biopharmaceuticals and other innovative products.
  • Develop innovative legal and policy solutions to complex coverage and reimbursement issues to promote patient access to innovative new products.
  • Advise clients in drafting new technology add-on payment applications.

PROFESSIONAL EXPERIENCE
  • U.S. Department of Health & Human Services, Washington, D.C. - Attorney, Office of the General Counsel, CMS Division
  • Biotechnology Innovation Organization (BIO), Washington, D.C. - Director, Health Law & Policy

Honors & Involvement

INVOLVEMENT
  • Member, American Health Law Association

Speaking Engagements

  • "A Look at the IRA's Drug Pricing Provisions from All Sides," AHLA Institute on Medicare and Medicaid Payment Issues (March 2024)
  • "Understanding the Environment for Pricing and Access to Medicines During an Election," BIO CEO & Investor Conference (February 2024)
  • "Government Regulations and Policy: Are They Stifling Innovation," Biotech Showcase (January 2024)
  • "Understanding the Fundamentals of the IRA and Its Impact," Academy of Managed Care Pharmacy's Nexus 2023 (October 2023)
  • "Inflation Reduction Act One Year Later - Where Are We Now?," Biotechnology Innovation Organization Webinar (September 2023)
  • "Demystifying the CMS CLFS Pricing Process," Semi-Annual Diagnostic Coverage & Reimbursement Conference (July 2023)
  • "...Or Your Money Back: Legal & Strategic Considerations for Pharmaceutical Warranty Programs," Foley Hoag Webinar (June 2023)
  • "The Inflation Reduction Act’s Outsized Impacts on the Massachusetts Ecosystem," MassBio State of Possible Conference (April 2023)
  • "Advancing Inclusivity and Equity in ACO Initiatives: Reaching CMS’s Goal of 100% Accountability by 2030," AHLA Institute on Medicare and Medicaid Payment Issues (March 2023)
  • "Understanding how the Inflation Reduction Act Impacts the Ecosystem," MassBio Forum (November 2022)
  • "Advancing Accountability and Equity Through Payment and Care Delivery," AHLA Institute for Medicare and Medicaid Payment Issues (March 2022) & AHLA Academic Medical Centers and Teaching Hospitals Law Institute (February 2022)
  • "Innovation in a Nutshell: Three Key CMS Payment Initiatives, Where They Came From, and What You Should Know," AHLA Institute on Medicare and Medicaid Payment Issues (March 2019)
  • "The 340B Program: Year in Review and What to Expect in 2016," AHLA Institute on Medicare and Medicaid Payment Issues (April 2016)
  • "Supply Chain Perspectives on Reimbursement and Other Regulatory Issues," 2016 HDMA Distribution Management Conference & Expo (March 2016)
  • "State Policy Changes & Updates Track," IIR’s Medicaid Drug Rebate Summit (September 2015)
  • "Medicaid Expansion and Waiver Programs," IIR’s Gross-To-Net Forum (March 2015)