Kyle Y. Faget

Of Counsel

Overview

Kyle Faget is of counsel and a business lawyer with Foley & Lardner LLP. She is a member of the firm’s Government & Public Policy Practice and the Health Care and Life Sciences Industry Teams. Her practice focuses on advising clients on regulatory and compliance matters involving the Food, Drug and Cosmetic Act, the False Claims Act, the Anti-Kickback Statute, the AdvaMed Code and the PhRMA Code. She also regularly drafts and negotiates agreements required for the development and commercialization of pharmaceutical and medical device products. Prior to joining the firm, Kyle held in-house positions at pre-commercial and commercial stage companies.

Pharmaceutical, Medical Device and Healthcare Compliance and Counseling

Kyle has been counseling clients on health care regulatory and compliance issues for more than a decade both as an in-house and a private practice attorney. Her practice includes assisting companies to structure, develop and implement corporate compliance programs suitable for pre-commercial stage and commercial stage pharmaceutical and medical device companies, including drafting core compliance policies and advising on Sunshine Act reporting obligations. She also works with companies to assess compliance risks associated with sales and marketing efforts. In this capacity, Kyle counsels clients on False Claims Act, Civil Monetary Penalties, including beneficiary inducement and Anti-Kickback Statute issues. Kyle conducts internal investigations and provides clients with strategic and tactical advice regarding government investigations. She has also assisted companies operating under Corporate Integrity Agreements and Deferred Prosecution Agreements and has managed Independent Review Organizations.

FDA Regulatory

Kyle regularly advises pharmaceutical and medical device clients regarding advertising and promotion issues, including off-label promotion. She regularly assesses marketing materials directed toward healthcare providers and direct-to-consumer advertising campaigns for compliance with the Food, Drug and Cosmetic Act and FDA Guidance documents. Kyle helps clients navigate through the new drug and device approval process.

Clinical Research, Clinical Trials and Life Sciences

Kyle has extensive experience drafting and negotiating agreements with and for contract/clinical research organizations and site management organizations. She regularly drafts and negotiates Clinical Trial Agreements, Informed Consents and other clinical development agreement on behalf of pharmaceutical and medical device clients. Additionally, Kyle has drafted and negotiated a broad swath of operational agreements for her pharmaceutical and medical device clients, including Contract Manufacturing Agreements, Distribution Agreements, Master Services Agreements and Material Transfer Agreements.

Telemedicine, Telehealth and Digital Health

“Foley’s Telemedicine & Digital Health Industry Team has been recognized by Chambers USA: America’s Leading Business Lawyers, which states: “Commentators describe the firm as ‘a market leader in telemedicine issues.’ ‘This is the Dream Team.’ " (Florida, 2020).

Kyle advises suppliers, physician practices, consultants and vendors and a variety of other health care entities on a range of business, legal and regulatory issues affecting the telemedicine industry. She handles matters involving contracting fraud and abuse compliance, Medicare and Medicaid reimbursement, self-disclosures and overpayments, the Anti-Kickback Statute, physician self-referrals (the Stark Law), health care marketing rules, HIPAA, corporate compliance programs, contracting, confidentiality and information sharing and policies and procedures.

Professional Memberships, Pro Bono and Community Involvement

Kyle is a member of the American Health Lawyers Association, and her pro bono work includes advising telemedicine clients regarding state laws impacting physician practices. Kyle currently serves as the chair of the board of directors of Fenway Health, a Federally Qualified Community Health Center.

Education

Kyle earned her law degree from the University of Michigan Law School (J.D. 2007), where she served as executive editor, Michigan Journal of Law Reform; and executive symposium editor, Michigan Telecommunications and Technology Law Review. She also received the Book Award, FDA Law (awarded to the top student in the FDA Law class). She holds a certificate in post-baccalaureate pre-medical studies from Bryn Mawr College (2002) and an A.B. in physiological psychology, with a minor in neuroscience, from Smith College (1997).

Admissions

Kyle is admitted to practice in Massachusetts.

Community Engagement

Kyle serves on the board of directors for Fenway Health as well as GLAD Legal Advocates and Defenders.

Speaking Engagements

  • Speaker, “Telemedicine’s New Frontier: Direct-to-Consumer Medicine,” ACC’s Virtual Annual Meeting, October 12-16, 2020
  • Speaker, “Regulation of Digital Health During and After COVID-19,” Food Drug Law Institutes, Digital Health Technology and Regulation During COVID-19 and Beyond, September 10, 2020
  • Speaker, “Federal Sunshine Act Changes and State Reporting Requirements,” ACC Webcast, August 26, 2020
  • Speaker, “Guidance for Deciding Whether to Reopen and Legal Implications of Reopening,” American Bar Association Health Law Webinar, May 22, 2020
  • Speaker, “Navigating the Legal and Regulatory Considerations of a Decentralized Trial,” 2nd Annual Virtual Clinical Trials, May 19-20, 2020
  • Speaker, “The New Drug Approval Process: NDA Submission and Review,” Food Drug Law Institute’s Introduction to Drug Law and Regulation, April 15-16, 2020
  • Speaker, Business of Personalized Medicine Summit 2020, February 27, 2020
  • Speaker, “Bringing 2020 Focus to Telemedicine Reimbursement,” TeleSpecialists Webin, February 5, 2020
  • Speaker, “Legal Update: Hot Topics in Long Term Care,” New England Alliance Annual Meeting, January 15-17, 2020
  • Speaker, “Telemedicine and Medical Devices: What You Need to Know,” MedTech Impact Expo & Conference, December 13-15, 2019
  • Speaker, “Walking the Fine Line: Compliant Patient Advocacy and HCP Engagement Strategies,” 5th Bio/Pharmaceutical Product Launch Summit, October 28-29, 2019
  • Speaker, “Ensuring Regulatory Alignment with Innovative Virtual Siteless Clinical Design Trial Methodologies and wearables to Support Drug Development,” RAPS Regulatory Convergence Conference, September 24, 2019
  • Speaker, “TeleHealth and Compliance Challenges,” HCCA’s Boston Regional Conference, September 6, 2019
  • Speaker, “Making Telehealth an Essential Component to Care Delivery for Older Adults,” American Telemedicine Association 2019 Annual Conference & Expo, April 14-16, 2019
  • Speaker, “What is Happening in Telehealth Policy?” NatCon19’s TLunch 10, March 26, 2019
  • Speaker, “Telemedicine and Direct to Consumer Medical Devices,” 10th Annual Global Partnership for Telehealth Conference, March 20-22, 2019
  • Speaker, “Legal Considerations in First Time CRO Contracts – Pitfalls, Risks and Protections,” CRO Partnership & Oversight Excellence, March 7, 2019
  • Speaker, “Digital Health and the FDA: Top 5 Legal Issues to Understand,” American Telemedicine Association, February 13, 2019
  • Speaker, “Up and Coming Technology,” Telehealth Technology Summit, New Orleans, Louisiana, December 13, 2018
  • Speaker, “Legal Issues in Telehealth Technology,” Telehealth Technology Summit, New Orleans, Louisiana, December 12, 2018
  • Speaker, “Telemedicine & Medical Devices: Legal and Regulatory Issues: Tech Vendor Key Issues, FDA Device Regulation and Certification, FDA Software as a Medical Device Regulation vs Clinical Decision Support Rules,” 5th Annual Florida TeleHealth Summit, St. Petersburg Beach, Florida, November 8, 2018
  • Speaker, “Telemedicine Regulations AHLA Distance Learning,” October 17, 2018
  • Panelist, “Telehealth Panel: Treating Patients Beyond the Physician’s Office,” WEDI’s 2018 National Conference, Washington, D.C., October 15, 2018
  • Speaker, “Direct-to-Patient Telemedicine Legal and Regulatory Considerations,” Northwest Regional Telemedicine Center, Salt Lake City, Utah, October 2, 2018
  • Speaker, “Telemedicine & Medical Devices: Legal and Regulatory Issues,” 7th Annual Alabama Telehealth Summit, August 14, 2018
  • Speaker, “Behavioral Health in a Digital World, Trends and Considerations,” Boston Health IT Summit, Boston, Massachusetts, August 8, 2018
  • Speaker, “Behavioral Health in a Digital World: Trends and Considerations,” Boston Health IT Summit, Boston, Massachusetts, August 7, 2018
  • Speaker, “The New Drug Approval Process, as part of FDLI’s Introduction to U.S. Drug Law and Regulation,” San Francisco, California, July 24, 2018
  • “FDA Regulatory Update: 510(k) Guidance, ACC Quick Hits,” May 1, 2018
  • Speaker, “The New GDPR Regulations: What Clinical Operations Needs to Know,” NE Clinical Operations Executive Breakfast, Cambridge, Massachusetts, April 24,2018
  • Speaker, “Reading the Tea Leaves: Recent Trends in Regulatory Enforcement of New England ALFs,” New England Regional Winter Conference and Annual Meeting, Woodstock, Vermont, January 10, 2018
  • Speaker, “FMV for Clinical Trial Best Practices,” Clinical Trial Legal and Contracting Forum, Philadelphia, Pennsylvania, December 4, 2017
  • Panelist, “Monitoring Non-Promotional Activities within a Complex Global Organization,” CBI Compliance Congress on Non-Promotional Activities, Philadelphia, Pennsylvania, July 2017
  • Speaker & Panelist, “Gain an Understanding of the Importance of FMV in Clinical Trials” & “Best Practices for Open Payments Reporting of HCP Spend,” CBI 4th Annual FMV Congress, Philadelphia, Pennsylvania, March 2017
  • Panelist, “A Conversation About Diversity and Inclusion: The Questions You Wanted to Ask,” Women in Law Empowerment Forum, Boston, Massachusetts, November 2016
  • Panelist, “Maintaining Effective Regulatory Compliance throughout the R&D Process,” CBI Compliance Congress for Specialty Products, Boston, Massachusetts, September 2016
  • Speaker, “Navigating Compliance and Legal Risks Impacting Distribution and Data Management,” CBI Specialty Product Distribution and Dispensing Optimization, Philadelphia, Pennsylvania, October 2015
  • Panelist, “The FCPA and Beyond: Navigating Global Compliance Risks and Government Investigations in the New International Economy,” Association of Corporate Counsel, Boston, Massachusetts, October 2015
  • Speaker, “Managing HCP Engagements to Avoid Kickback Allegations,” CBI Compliance Congress for Specialty Products, Boston, Massachusetts, September 2015

Publications

  • Quoted, “Can Virtual Trials Maintain Their Momentum After COVID?”, Clinical Leader, September 17, 2020
  • “Telehealth Today and in a Post-COVID-19 World,” Health Care Law Today, September 1, 2020
  • “EUAs for LDTs no Longer Required, but at the Expense of PREP Act Immunity,” Health Care Law Today, August 24, 2020
  • “COVID-19: FDA Issues Template for Over-the-Counter At-Home Testing,” Health Care Law Today, July 30, 2020
  • “COVID-19: FDA Clears Path for Test to Screen Asymptomatic Individuals,” Coronavirus Resource Center: Back to Business, July 23, 2020
  • “HCP Conflicts of Interest: Virtual Informational Sessions – With Lunch – Supported by PhRMA During Declared Emergencies,” Coronavirus Resource Center: Back to Business, July 15, 2020
  • “Telehealth in the Wake of COVID-19,” Journal of Health Care Compliance, May 18, 2020
  • “FDA Increases Scrutiny of COVID-19 Serology Tests: What Commercial Manufacturers Need to Know,” Coronavirus Resource Center: Back to Business, May 6, 2020
  • “Episode 10: Telehealth in the Time of COVID-19,” Health Care Law Today Podcast, May 5, 2020
  • “Episode 9: Clinical Trails in the Time of COVID-19,” Health Care Law Today Podcast, April 29, 2020
  • “COVID-19: CMS Issues Telehealth Guidance for State Medicaid and CHIP Programs,” Health Care Law Today, April 28, 2020
  • “COVID-19: Idaho Governor Suspends More Regulations Relating to Telehealth and Medical Licensing,” Health Care Law Today, April 13, 2020
  • “COVID-19: New York’s Medicaid Expansion of Telehealth During the State of Emergency,” Health Care Law Today, March 31, 2020
  • “Telehealth (Massachusetts): COVID-19 Inspires Relaxed Telemedicine Technology Requirements and Mandates Payment Parity,” Health Care Law Today, March 18, 2020
  • “Telemedicine Compliance: The Practice Requirements,” Journal of Health Care Compliance, March 1, 2020
  • “Clinical Decision Support Software: FDA’s Risk-based Approach,” Asian Hospital and Healthcare Management, March 1, 2020
  • “2020 Business of Personalized Medicine Summit: Break Through to Solutions in the Birthplace of Biotechnology,” Personalized Medicine Bulletin, February 18, 2020
  • “Telehealth: Massachusetts’ Proposed Act to Improve Health Care by Investing in Value,” Health Care Law Today, January 29, 2020
  • “Drug Pricing Transparency: Massachusetts’ Proposed Reporting Requirements,” Health Care Law Today, December 19, 2019
  • “Clinical Research Compliance Manual: An Administrative Guide,” November 21, 2019
  • Quoted, “FDA releases revised draft guidance on CDS software, final guidelines on ‘device’ definitions for software such as wellness apps,” MobiHealthNews, September 26, 2019
  • “Fact or Fallacy: Is Telehealth Here to Stay?”, HealthTech, August 1, 2019
  • “Blockchain: A Tool With a Future in Healthcare,” Health Care Law Today, July 18, 2019
  • “Pharmacies: DOJ Wins TRO to Immediately Suspend Registration for Controlled Substances,” Health Care Law Today, March 28, 2019
  • Quoted, “New Medicaid Telehealth Standards in Massachusetts Draw Criticism,” mHealth Intelligence, March 5, 2019
  • “The Good and the Bad of the New MassHealth Telemedicine Rule,” Health Care Law Today, March 4, 2019
  • Quoted, “Biosimilars, diabetes and HCV drug uptake expected to spike with HHS changes restricting safe harbor protection for PBMs and drug manufacturers, experts say,” BioPharm Insight, February 20, 2019
  • Quoted, “Massachusetts Push for Telehealth Parity,” Politico, February 5, 2019
  • “HHS Proposes New Rules to Eliminate Drug Rebates and Encourage Direct Discounts for Federal Beneficiaries,” Health Care Law Today, February 1, 2019
  • Quoted, “FDA looks to De Novo Pathway Model As it Unveils Updates to Pre-Cert Program,” MobiHealthNews, January 8, 2019
  • “ACA Strike-Down: Salvaging the BPCIA via Severability,” Health Care Law Today, January 2, 2019
  • Quoted, ACA Repeal Wouldn't Stop Transition to Value-Based Payment, Efforts to Lower Drug Spending,” Modern Healthcare, December 19, 2018
  • Quoted, “Proposed Framework Lessens FDA's Regulatory Requirements for Prescription Drug Companion Apps,” MobiHealthNews, November 19, 2018
  • “cGMP Violations Should Not Be Used as a Basis for FCA Actions Absent Fraud,” 38 Seattle U. L. Rev. 37 (2014)
  • “Limits on cGMP Violations under the FCA,” 2 Fraud & Abuse, 1 (2013)
  • “The Misuse of the FCA to Enforce cGMP (Current Good Manufacturing Practice) Violations,” 6 No. 24 International In-House Counsel Journal, 1 (2013)
  • “Why FDCA § 505(u) Should Not Concern Us Greatly,” 15 Michigan Telecommunications and Technology Law Review, 453 (2009)
  • Georgia v. Ashcroft: A New Statistical Model,” 13 Georgetown Public Policy Review 45 (2007-08)

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