Jennifer Csik Hutchens

Jennifer Hutchens BCLP Law
  1. People /

Jennifer Csik Hutchens

Jennifer Csik Hutchens

Partner


Charlotte
Jennifer Hutchens BCLP Law
  1. People /

Jennifer Csik Hutchens

Jennifer Csik Hutchens

Partner


Charlotte

Jennifer Csik Hutchens

Partner

Charlotte

Partner and Global Leader - Healthcare & Life Sciences Team

T: +1 704 749 8931

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Biography

Jennifer Hutchens is the global leader of BCLP’s Healthcare & Life Sciences Practice. She represents hospitals and health systems, academic medical centers, clinical research groups, ancillary service providers, licensed agencies, non-profits, management services organizations, medical device companies, and other industry-based clients of all sizes. In the midst of complex and highly technical regulatory landscapes, clients rely on Jennifer to help achieve their strategic, operational and compliance goals.

Jennifer builds and maintains long-term relationships with clients and is a trusted partner and adviser. She is on the forefront of cutting-edge topics in the industry and leads the practice’s initiatives and direction in these areas, including FemTech, behavioral health, and digital transformation.  She has a strong passion for the healthcare and life sciences industries and particularly excels in advising clients as they implement novel, first-of-their-kind solutions and transactions. She regularly advises clients on topics of health innovation, including artificial intelligence (AI), telehealth, and concierge medicine. Jennifer also enjoys assisting companies that are pivoting their business into the healthcare and life sciences industries for the first time, providing client intelligent solutions.

Jennifer has deep experience interpreting federal and state healthcare guidance, including the Anti-Kickback and Stark laws, corporate practice of medicine and fee-splitting prohibitions, federal Physician Sunshine Transparency Act, surprise/balance billing laws and price transparency rules.

Jennifer's transactional practice is focused on joint ventures, mergers and acquisitions, and other affiliation and collaboration transactions, as well as healthcare contracting matters (professional services, managed and value-based care, and other arrangements).

Specifically in the managed care and value-based care arena, Jennifer has been a go-to resource for clients. She provides holistic guidance and practical solutions. This includes the negotiation and interpretation of managed care and participation agreements, navigation of risk- and value-based reimbursement methodologies, and commercial approaches to related compliance and technical considerations. Jennifer has specific experience with CMS innovation models, such as the Accountable Care Organization Realizing Equity, Access, and Community Health (ACO REACH) Model.

Civic Involvement & Honors

  • North Carolina Super Lawyers
    • Rising Star, 2013-2021
    • Super Lawyer Health Care, 2023-2024
  • Best Lawyers of America - Healthcare Law, 2015-2025
  • Chambers USA: America’s Leading Business Lawyers - Healthcare, 2018-2023
  • Career Choices in the Law (Charlotte Mecklenburg Middle Schools) - Mentor, 2023-present
  • North Carolina Lawyers Weekly Healthcare Power List, 2023
  • Duke Alumni Admissions Program - Admissions Interviewer, 2007-present
  • Coca-Cola Scholars Foundation - Scholar & Alumna, 1999-present
  • Toyota Scholars - Scholar & Alumna, 1999-present
  • Charlotte Healthcare Law Lawyer of the Year, 2018
  • Mecklenburg County Bar Young Lawyers Division - Young Lawyer of the Year, 2011

American Health Law Association

  • Board of Directors, 2023-present
  • Development and Advancement Council, 2020-2023
  • Nominating Committee, 2019-2020
  • Fundamentals in Health Law Conference Planning Committee, 2017-2023
  • Governance Advisory Council, 2017-2019
  • Young Professionals Delegate to Board, 2016-2017
  • Young Professionals Council - Chair 2014-2016, Vice-Chair 2013-2014
  • Hospital and Health Systems Practice Group Leadership Development Program, 2012-2021
  • Best Practices Health Law Curriculum Steering Committee, 2014

Leadership Council on Legal Diversity - Fellow, 2021

North Carolina Bar Association 

  • Member, 2009-present
  • Health Law Section Council - Chair 2017-2018
  • Vice Chair, 2016-2017
  • Secretary, 2015-2016
  • Treasurer, 2014-2015

North Carolina Society of Health Care Attorneys

  • Member, 2013-present
  • Education Committee, 2013-2016

American College of Healthcare Executives, Member

Women Business Leaders of the U.S. Health Care Industry Foundation, Member

Greater Charlotte Healthcare Executives, Member

American Bar Foundation Fellow

Admissions

  • North Carolina, 2007

Education

Duke University-School of Law, J.D., Order of the Coif, summa cum laude, 2007

Duke University, B.A., Phi Beta Kappa, summa cum laude, 2003

Related Practice Areas

  • M&A & Corporate Finance

  • Public Policy & Government Affairs

  • Private Equity

  • Non Profit Organizations

  • False Claims Act

  • Corporate

  • Investigations

  • Public Sector

  • Healthcare & Life Sciences

  • Commercial Contracts

Experience

Strategic, Operational and Compliance Counsel

  • Serves as outside general counsel to mid-Western health system, providing regular operational and compliance advice and counsel, including regarding value-based care arrangements and new patient program rollouts.
  • Provided comprehensive counsel to a North Carolina health system in connection with its pilot virtual hospital program offering for orthopedic patient recovery.
  • Counsels a variety of healthcare industry clients in connection with telemedicine, digital health, remote patient monitoring/prescribing and virtual care (e.g., informed consent, state professional licensure, scope of practice, corporate practice, telemedicine credentialing and reimbursement); including specific experience with dentistry, dermatology, and veterinary medicine, among other sub-specializations.
  • Interprets federal and state healthcare guidance in connection with surprise/balance billing and transparency for hospitals and health systems, laboratories, radiology platforms, and other ancillary service providers.
  • Serves as strategic counselor to preeminent retailer for pet products, supplies, and prescriptions, including related to health, insurance and pharma platform offerings.
  • Provides risk mitigation strategies and best practice advice and guidance to clients as they implement evolving and disruptive technologies, including the implementation of artificial intelligence-informed software and solutions.
  • Offers best practices advice and guidance to clients pursuing concierge or other alternative medical practice models, ranging from provider/patient contracts and related policies and procedures, to compliance (including federal law issues such as Medicare billing (opt out) rules as well as unique state law issues such as scope of practice, corporate practice, fee-splitting, and insurance laws).
  • Counseled national radiology platform and its affiliated practices and service lines on a variety of corporate, healthcare, operational, and regulatory matters.
  • Led healthcare due diligence review and analysis on behalf of an international public healthcare company for its $2 billion acquisition of a home dialysis equipment maker.
  • Serves as local regulatory counsel in connection with large transactions, advising out-of-state buyers/sellers on state and local laws and regulations in the Carolinas.

Outside General Counsel

  • Served as outside general counsel to the national testing organization for the profession of optometry.
  • Served as outside general counsel to an innovative joint venture – composed of 12 health systems – formed to operate a provider-led and patient-centered health plan participating in the North Carolina Managed Medicaid Program.
  • Served as outside general counsel to a North Carolina critical access hospital, providing advice on legal, transactional and strategic matters.
  • Served as outside general counsel to a collaborative business venture between seven behavioral health providers pursuing innovation in care in North Carolina.

Transaction/Corporate Healthcare Counsel

  • Advises healthcare industry stakeholders (including providers and professional and trade organizations) in the development of business relationships, affiliations, combinations and integrations.
  • Represented a national healthcare corporation in the negotiation and development of joint venture operations with other hospitals and physician partners.
  • Counseled a national healthcare corporation in its purchases of a wide range of business operations, including dialysis clinics, vascular access centers and physician practice management services.
  • Assisted with corporate representation of a North Carolina insurance company in acquiring minority interest in an urgent care company with multistate clinic operations.

Resources

Publications

A selection of written insights:

  • Quoted, "Biotechs Walk Tightrope on Drug Price Negotiation Messaging", August 13, 2024, Law 360 Healthcare Authority
  • Quoted, “The Most Influential Healthcare Deals so Far in 2024”, July 23, 2024, Law360 Healthcare Authority
  • Quoted, “Healthcare Dealmaking Trends of 2024: A Midyear Review”, July 2024, Law360 Healthcare Authority
  • “Navigating the FemTech Regulatory Landscape:  Best Practice & Future Developments”, July 19, 2024, BCLP
  • “Navigating the FemTech Regulatory Landscape: Which Rules Apply and What Are the Enforcement Priorities?”, May 16, 2024, BCLP
  • "Health Care Contracts: A Clause-by-Clause Guide to Drafting and Negotiation - 2nd Edition", March 2024, American Health Law Association
  • “What is FemTech and How Can it Meet the Privacy Needs of its Users?”, March 8, 2024, BCLP
  • “Lessons from the Growth of FemTech and Women’s Health”, February 21, 2024, BCLP
  • “New Final Rule Requires U.S. Nursing Homes Disclose Ownership Structure”, December 5, 2023, BCLP
  • “HHS Proposed Rule to Establish Penalties for Committing Information Blocking: What Providers Need to Know”, November 3, 2023, BCLP
  • “State Regulation of Physician Practice Transactions: What Investors Need to Know”, November 1, 2023, BCLP
  • “U.S. Healthcare and Life Sciences Alert: CMS Updates ACO Reach Program to Encourage Increased Participation”, August 23, 2023, BCLP
  • “RWI Market Turning to Unlikely Industries for New Deals: Health Care RWI Terms & Conditions Improving”, August 1, 2023, BCLP
  • “Five Years On: EKRA’s Legacy”, July 20, 2023, BCLP
  • “U.S. Health Care Industry: Risk Mitigation Tips in the Post- Supervalu FCA Landscape”, June 15, 2023, BCLP
  • “U.S. Health Care Industry: Practice Tips for Navigating FCA Landscape (From Supervalu and Beyond)”, April 20, 2023, BCLP
  • “U.S. Health Care Industry Takes Note: U.S. Supreme Court 2023 Attention on False Claims Act”, April 19, 2023, BCLP
  • “Regulatory Reform Could Hasten Transition to Value-Based Care”, October 2018, Hospitals & Health Systems RX, AHLA Newsletter
  • “Legal and Operational Guide for Free Medical Clinics”, September 16, 2015, AHLA and AMA

Speaking Engagements

A selection of events:       

  • The Fundamentals of Health Care Transactions: Case Study and Perspectives from In-House and Outside Counsel Teams

    American Health Law Association 2024 Fundamentals of Health Law Conference (Chicago, IL)


    Forthcoming: November 19, 2024

  • Hot Topics in Health Law 2024
    BCLP CLE (Phoenix, AZ)
    June 11, 2024

  • Healthcare Fraud Enforcement: Mitigating Risk in 2024 and Beyond
    BCLP CLE Webinar (virtual)
    June 6, 2024

  • Primer on Health Care Transactions: In-House and Outside Counsel Conversations


    American Health Law Association 2024 Health Care Transactions Conference (Nashville, TN)
    April 15, 2024

  • International Expansion: Select Global Legal and Compliance Considerations
    St. Jude Children’s Research Hospital (Memphis, TN)
    March 19, 2024

  • Hot Topics in Health Law 2024


    BCLP Presentation (Miami, FL)
    March 14, 2024

  • FemTech: US Legal Considerations at a Glance


    BCLP Webinar (virtual)
    March 7, 2024

                  
  • Health Care Buzz in 2023: What You Need to Know to be a Good Partner


    Home Medical Equipment National Conference (Charlotte, NC)
    October 23, 2023

  • Primer on Health Care Transactions: In-House and Outside Counsel Conversations


    AHLA Health Care Transactions Conference (Nashville, TN)
    April 17-19, 2023

  • Mentorship – What Works, What Doesn’t and Where to Begin
    AHLA webinar
    June 24, 2021
  • AKS and Stark Law 2021 Updates: Driving Innovation
    Client webinar
    May 7, 2021
  • Telehealth, Remote Care and Home Care – Legal and Practical Considerations
    i2i Center for Integrative Health webinar
    Dec. 2, 2020
  • The Fundamentals of Health Care Transactions
    AHLA Fundamentals of Health Law Conference (Chicago, IL)
    Nov. 13, 2020
  • Deeper Dive into Health Care Transactions: Adding Value in Deal Negotiations
    AHLA Fundamentals of Health Law Conference (Chicago, IL)
    Nov. 13, 2020
  • COVID-19 Behavioral Health Virtual Roundtable Series: What’s Next?
    Client webinar
    July 21, 2020
  • COVID-19 Behavioral Health Virtual Roundtable Series: Deeper Dive on Employment and Labor
    Client webinar
    May 13, 2020
  • Health Care Practice Group Virtual Roundtable Series: COVID-19 & Medical Practices
    Client webinar
    May 1, 2020
  • COVID-19 Behavioral Health Virtual Roundtable Series: Telehealth Deeper Dive
    Client webinar
    April 30, 2020
  • Behavioral Health Virtual Roundtable Series: Protecting Your Organization and COVID-19
    Client webinar
    April 16, 2020
  • Health Care Practice Group Virtual Roundtable Series: Innovative Businesses Shift to Respond to COVID-19
    Client webinar
    April 9, 2020
  • Behavioral Health Virtual Roundtable Series: COVID-19 & NC’s Behavioral Health Industry
    Client webinar
    April 3, 2020
  • Legal Updates 2019: Forging a Path Forward in a Time of Change
    i2i Center for Integrative Health Conference (Pinehurst, NC)
    Dec. 4, 2019
  • The Fundamentals of Health Care Transactions
    AHLA Fundamentals of Health Law Conference (Chicago, IL)
    Nov. 17, 2019
  • Deeper Dive into Health Care Transactions: Adding Value in Deal Negotiations
    AHLA Fundamentals of Health Law Conference (Chicago, IL)
    Nov. 17, 2019
  • The Path to Trusted Health Care Law Advisor
    AHLA Annual Meeting (Boston, MA)
    June 26, 2019
  • The Fundamentals of Health Care Transactions
    AHLA Fundamentals of Health Law Conference (Chicago, IL)
    Nov. 13, 2018
  • Deeper Dive into Health Care Transactions: Adding Value in Deal Negotiations
    AHLA Fundamentals of Health Law Conference (Chicago, IL)
    Nov. 13, 2018
  • The Fundamentals of a Health Care Transaction
    AHLA Fundamentals of Health Law Conference (Chicago, IL)
    Nov. 15, 2016

Related Insights

Insights
May 16, 2024

Navigating the FemTech regulatory landscape

Security, scale or functionality – pick two. This computer science principle coined by the late Professor Anderson is particularly relevant to the FemTech industry. Anderson’s Rule states that for a system to provide high functionality and security, its access may need to be limited (small scale); alternatively, offering high functionality on a larger scale, may require an acceptance of risk, e.g. of inadvertent or deliberate disclosure of information. In real life systems - including FemTech - a balance must be struck. It is no surprise, then, that the regulatory landscape for FemTech is complex and fragmented. Different jurisdictions approach the question of health/medical data in diverse ways and apply different laws and standards to the protection of personal data. All these rules are ultimately intended to mitigate the risks to personal data posed by large databases of sensitive personal information while facilitating the benefits. In part two of our series, we examine the UK, EU and US regulatory privacy landscapes and enforcement priorities and how they apply to the FemTech sector. For more, read our previous article "What is femtech and how can it meet the privacy needs of its users?".
Insights
Mar 08, 2024

What is FemTech and how can it meet the privacy needs of its users?

In part one of our series "FemTech: how this growing industry can build trust, protect privacy and redress healthcare inequity… one app at a time", we take an introductory look at the industry, and offer some commercially-minded approaches to address users’ privacy needs.
Insights
Feb 21, 2024

Lessons from the growth of FemTech and women’s health

BCLP’s Healthcare & Life Sciences Practice Group recently partnered with EMIG Digital Health Group to co-host an in-person breakfast seminar and networking event focused on FemTech. Specialists from across the FemTech and wider digital health, pharma and life sciences sectors heard speakers from Flo Health, Apricity and Theramex, amongst others, discuss key themes and lessons learnt from the growth of FemTech. Chaired by Darren Spevick, Managing Director of Russell Strategy Partners, topics discussed included the ecosystem and market and how innovation, effective partnerships, high quality content, and a simple and tangible digital strategy can drive growth in the sector. Attendees also heard from members of BCLP’s dedicated FemTech team about the current themes in, and the direction of travel for, UK and EU privacy and data protection and how robust compliance can help to fuel trust and drive value.
Insights
Dec 05, 2023

New final rule requires U.S. nursing homes disclose ownership structure

On November 17, 2023, the Centers for Medicare and Medicaid (CMS) published a final rule implementing additional disclosure requirements for U.S.-located, Medicare skilled nursing facilities and Medicaid nursing facilities (nursing facilities).  This additional information will be available to the public via a CMS website.  According to CMS, the intent behind the new regulations is to (i) allow the public to be better informed about the ownership of the nursing facilities they use and (ii) allow CMS to better track quality and cost outcomes for facilities owned or operated by private for-profit companies, like private equity companies (PECs) and real estate investment trusts (REITs).

Related Insights

Insights
Jul 19, 2024
Navigating the FemTech regulatory landscape: best practice & future developments
Insights
May 16, 2024
Navigating the FemTech regulatory landscape
Security, scale or functionality – pick two. This computer science principle coined by the late Professor Anderson is particularly relevant to the FemTech industry. Anderson’s Rule states that for a system to provide high functionality and security, its access may need to be limited (small scale); alternatively, offering high functionality on a larger scale, may require an acceptance of risk, e.g. of inadvertent or deliberate disclosure of information. In real life systems - including FemTech - a balance must be struck. It is no surprise, then, that the regulatory landscape for FemTech is complex and fragmented. Different jurisdictions approach the question of health/medical data in diverse ways and apply different laws and standards to the protection of personal data. All these rules are ultimately intended to mitigate the risks to personal data posed by large databases of sensitive personal information while facilitating the benefits. In part two of our series, we examine the UK, EU and US regulatory privacy landscapes and enforcement priorities and how they apply to the FemTech sector. For more, read our previous article "What is femtech and how can it meet the privacy needs of its users?".
Events
Apr 15, 2024
American Health Law Association’s Health Care Transactions Program
Insights
Mar 08, 2024
What is FemTech and how can it meet the privacy needs of its users?
In part one of our series "FemTech: how this growing industry can build trust, protect privacy and redress healthcare inequity… one app at a time", we take an introductory look at the industry, and offer some commercially-minded approaches to address users’ privacy needs.
Insights
Feb 21, 2024
Lessons from the growth of FemTech and women’s health
BCLP’s Healthcare & Life Sciences Practice Group recently partnered with EMIG Digital Health Group to co-host an in-person breakfast seminar and networking event focused on FemTech. Specialists from across the FemTech and wider digital health, pharma and life sciences sectors heard speakers from Flo Health, Apricity and Theramex, amongst others, discuss key themes and lessons learnt from the growth of FemTech. Chaired by Darren Spevick, Managing Director of Russell Strategy Partners, topics discussed included the ecosystem and market and how innovation, effective partnerships, high quality content, and a simple and tangible digital strategy can drive growth in the sector. Attendees also heard from members of BCLP’s dedicated FemTech team about the current themes in, and the direction of travel for, UK and EU privacy and data protection and how robust compliance can help to fuel trust and drive value.
Insights
Dec 05, 2023
New final rule requires U.S. nursing homes disclose ownership structure
On November 17, 2023, the Centers for Medicare and Medicaid (CMS) published a final rule implementing additional disclosure requirements for U.S.-located, Medicare skilled nursing facilities and Medicaid nursing facilities (nursing facilities).  This additional information will be available to the public via a CMS website.  According to CMS, the intent behind the new regulations is to (i) allow the public to be better informed about the ownership of the nursing facilities they use and (ii) allow CMS to better track quality and cost outcomes for facilities owned or operated by private for-profit companies, like private equity companies (PECs) and real estate investment trusts (REITs).
Insights
Nov 03, 2023
HHS Proposes Rule to Establish Penalties for Committing Information Blocking: What Providers Need to Know
Insights
Nov 01, 2023
State Regulation of Physician Practice Transactions: What Investors Need to Know
Insights
Aug 23, 2023
U.S. Healthcare and Life Sciences Alert: CMS Updates ACO REACH Program to Encourage Increased Participation