Catherine assists health care organizations and life science companies on a variety of regulatory compliance and transactional matters. Her clients include medical device companies, hospitals, health systems, clinics, home care providers, behavioral health providers and licensed health care professionals.
Catherine advises clients on a wide range of complex state and federal regulatory and compliance matters in the health care field, including HIPAA, FDA regulations, clinical trial issues, Medicare and Medicaid enrollment and reimbursement, cybersecurity, state and federal transparency reporting requirements, telemedicine/telehealth arrangements, and fraud and abuse prohibitions. She routinely assists clients in drafting and negotiating health care and life science agreements, structuring business transactions and counsels clients on the regulatory issues surrounding change of ownership and business expansion into new jurisdictions. Catherine also advises clients in developing compliance program policies and procedures, responding to government investigations and risk management issues.
- Represents companies in connection with the marketing and sale of medical devices and other health care products and services in the United States.
- Counsels clients on clinical trials issues and provides legal advice and contracting support regarding clinical trial agreement negotiation and enrollment of study sites, including advising on issues relating to informed consent and IRB matters.
- Drafts and negotiates a variety of research-related documents for life science companies, including:
- Clinical Trial Agreements
- Strategic Alliance Agreements
- Collaboration Agreements
- Agreements with Clinical Research Organizations
- Informed Consent Forms
- Advises clients on FDA matters, including post-market issues such as labeling, marketing and promotion of regulated products.
- Consults with medical device companies regarding compliance with the federal Physician Payment Sunshine Act and similar state transparency laws.
- Advises clients on structuring telemedicine and telehealth arrangements and counsels clients on issues relating to cross-border compliance, licensure and scope of practice for direct-to-patient, peer-to-peer and remote monitoring telemedicine business models.
- Advises hearing aid manufacturers and dispensers in complex regulatory and business matters.
- Prepares, negotiates and advises clients on a variety of health care agreements, including professional services agreements, management agreements and other transactional documents.
- Advises health care clients on licensure, scope of practice and provider enrollment issues.
- Assists with complex issues relating to corporate practice of medicine and compliance considerations for health care clients across the country.
- Represents health care providers in complex and strategic transactions, including acquisitions and divisional mergers.
- Conducts workforce training and prepares HIPAA policies and procedures for health care clients.
- Assesses coverage and reimbursement for products and services from Medicare and Medicaid, as well as state and private payors.
- Advises dental management companies on regulatory issues involved in acquisition and multi-state expansion, including the corporate practice of medicine, fee-splitting, anti-kickback and Stark matters.
Articles & Presentations
PUBLICATIONS & PRESENTATIONS
- Co-Presenter, “2018 Medicare Regulatory Update,” Health Law Webinar Series, December 13, 2017
- Presenter, “Top Health Law FAQs for Hospitals and Clinics,” Fredrikson & Byron Health Health Law Webinar Series, July 12, 2017
- Presenter, “New Rules: MIPS, Physician Fee Schedule, Outpatient Rule and More!,” Fredrikson & Byron Health Health Law Webinar Series, December 14, 2016
- Presenter, “Digital, Mobile and Virtual Medicine: Legal Challenges,” Fredrikson & Byron Health Health Law Webinar Series, May 11, 2016
- Presenter, “Key Topics from the 2016 Medicare Physician Fee Schedule, Hospital Outpatient Rule and the Budget Act,” Fredrikson & Byron Health Health Law Webinar Series, December 9, 2015
- Presenter, “Clinical Trial Agreements: Best Practices for Effective Negotiations,” Fredrikson & Byron Health Health Law Webinar Series, July 8, 2015
- Presenter, “Telemedicine and Telehealth,” Fredrikson & Byron Health Law Webinar Series, July 9, 2014
- Presenter, “Understanding the Sunshine Act: What Physicians and Hospitals Need to Know,” Fredrikson & Byron Health Health Law Webinar Series, June 11, 2014
- Presenter, “Direct Pay Practice Arrangements,” Fredrikson & Byron Health Law Webinar Series, January 8, 2014
- Presenter, “340B Drug Discount Program,” Fredrikson & Byron Health Health Law Webinar Series, May 8, 2013
Honors & Education
- University of Minnesota Law School, J.D., 2012, magna cum laude, Health Law Concentration
- University of Minnesota School of Public Heath, M.P.H., 2012
- College of St. Benedict, B.A., 2007, summa cum laude
- Minnesota, 2012
- Cancer Legal Line Advocacy Award, 2013
- ABA-BNA Award in Health Law, 2012
- Order of the Coif
- Sidney J. Kaplan Legal Scholarship Fund Award, 2012
- Law and Inequality: A Journal of Theory and Practice, Lead Managing Editor, 2010-2011; staff member, 2009-2010
- Minnesota State Bar Association, Health Law Section; Food and Drug Law Section, Governing Council Member
- American Health Lawyers Association
- University of Minnesota Joint Degree Program in Law, Science and Technology, Advisory Board Member
- American Bar Association
- Volunteer, Cancer Legal Line, 2013-present