R. Jeffrey Layne

Partner

Fulbright & Jaworski LLP

R. Jeffrey Layne

Austin

T:+1 512 536 4593

F:+1 512 536 4598

Jeff Layne joined the Washington, D.C. office in 1998 and moved to the Austin office in 2005. His practice focuses on federal and state regulatory, administrative, and litigation-related health law matters, including Medicare and Medicaid fraud and abuse and research compliance issues. His health-related litigation experience includes criminal, False Claims Act and administrative litigation related to a wide variety of Medicare and Medicaid fraud and abuse, reimbursement, and compliance issues.

Jeff represents clients from across the spectrum of the healthcare industry, including hospital systems, university health systems, pharmaceutical and medical device manufacturers and distributors, pharmacies, suppliers, and managed care organizations.

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  • Education

    1998 - M.P.H., Harvard University
    1994 - J.D., Duke University Law School
    1990 - B.B.A., magna cum laude, Finance, Texas Christian University

    Jeff was admitted to practice law in Texas in 1994 and in the District of Columbia in 1999.

  • Representative experience

    Significant matters include:

    A. Life Sciences Industry

    • Development, implementation, and evaluation of compliance programs for multiple medical device companies.
    • Representation of device manufacturer in grand jury investigation and civil litigation regarding business practices.
    • Advise national DME manufacturer and supplier regarding compliance and competitive bidding issues.
    • Representation of national retail pharmacy chain in coordinated federal and state investigations of dispensing practices affecting Medicaid claims.
    • Representation of an international diagnostics company in regulatory and compliance matters and internal audits.
    • Representation of multiple pharmaceutical companies in National Medicaid Fraud Task Force and Texas Attorney General investigations regarding physician relationships and marketing activities.
    • Representation of pharmaceutical wholesalers in National Medicaid Fraud Task Force and Texas Attorney General investigations regarding Medicaid rebates, and in compliance issues related to drug pedigree rules.

    B. Healthcare Providers

    • Representation of hospitals in government investigation and False Claims Act suits related to issues of medical necessity (e.g., one day stays), billing fraud, and kickbacks.
    • Representation of hospitals and health systems throughout Texas and Louisiana in fraud and abuse and compliance matters, including internal investigations and internal audits.
    • Representation of a large hospital system in Louisiana in a class action lawsuit involving hospital collection of third party liability settlement proceeds.
    • Representation of hospitals in Texas, South Carolina, and Alabama in litigation involving hospital charges and collections from the uninsured.
    • Representation of healthcare systems in Texas, Arkansas, and New Jersey in administrative appeals involving Medicare "Loss on Sale" provisions.
    • Representation of hospital systems in internal and government investigations and self-disclosures.
    • Representation of hospital systems and university health systems in False Claims Act litigation.
    • Representation of providers in administrative overpayment hearings.

    C. Managed Care

    • Representation of national HMO in False Claims Act litigation.
    • Representation of an HMO in litigation against the state of Washington involving operation of the state's Medicaid managed care program.
  • Professional activities
    • American Bar Association - Health Law Section, former Vice Chair for Programming
    • District of Columbia Bar Association - Health Law Section
    • State Bar of Texas - Health Law Section
  • Professional honors
    • Client Choice Award - Texas: health care and life sciences, International Law Office (2013)
  • Speaking engagements
    • Presenter, "Collecting, Controlling and Certifying Indirect Payments from CROs and Third Party Vendors," ACI Forum on Sunshine Act Compliance & Aggregate Spend Reporting, New York, NY, October 7, 2013
    • Presenter, "A View from the FCPA Defense Bar on Enforcement Activities in Healthcare and Life Sciences," American Health Lawyers Association, October 3, 2013
    • Presenter, "Operationalize Your Compliance Program," MDMA 6th Annual Medical Technology Executive Forum, Palo Alto, CA, September 19, 2013
    • Presenter, "Regulatory Challenges and Current Trends," IBA World Life Sciences Conference, Dallas, TX, May 3, 2013
    • Presenter, "Compliance Complexities and the Pitfalls to Avoid for Emerging Life Sciences Companies," MDMA 2013 Annual Meeting, Washington DC, April 17, 2013
    • Presenter, "Effective Compliance Programs: Mitigating Risk in Latin America," AdvaMed 2013 Latin America Compliance Conference, Miami, FL, January 17, 2013
    • "Cost Efficient Compliance Programs for Small and Medium Enterprises," 2012 International Medical Device Industry Compliance Conference, Stockholm, Sweden, May 10, 2012. 
    • Co-presenter, "Back to School with Stark," Dallas-Fort Worth Hospital Council, August 29, 2012
    • Panelist, "Compliance: Current Investigative Initiatives," Fulbright & Jaworski L.L.P. Eighth Annual Health Law Symposium, February 2-3, 2012
    • Co-presenter "Compliance Investigations," "Overpayments Part 1: Billing Issues," and "Overpayments Part 2: Stark Issues," Legal Issues Boot Camp for Compliance Professionals, June 7-8, 2011
    • "Compliance--Voluntary Refunds and Disclosures: Not So 'Voluntary' Anymore," Fulbright & Jaworski L.L.P. Seventh Annual Health Law Symposium, February 3-4, 2011
  • Publications
    • Co-author, "Changes Proposed to Sunshine Act Reporting: Would Remove CME Exclusions May Broaden Availability of 'Indirect-Payment' Exclusions," Compliance Commoner, July 2014
    • Co-author, "CMS Delays Data Submission at Least 30 Days," Health Law Update, February 19, 2014
    • Co-author, "CMS Offers New Resources and Guidance on Two-Phase Approach to Sunshine Act Reporting," Sunshine Act forecast, February 2014
    • Co-author, "New Data Submission Resources Available for Sunshine Act Reporting," Norton Rose Fulbright - Sunshine Act forecast, November 4, 2013
    • "Principally in charge of Sunshine Act Task Force publications"
    • Co-author, "Industry user guide released," Norton Rose Fulbright - Sunshine Act forecast, August, 19, 2013
    • Co-author, "CMS publishes new Sunshine Act resources", Norton Rose Fulbright - Sunshine Act forecast, August, 8, 2013
    • Co-author, "The Sunshine Act's international reach," Norton Rose Fulbright - Sunshine Act forecast, July 3, 2013
    • Co-author with Benjamin Koplin and Selina Coleman, "CMS Hosts a National Provider Call Relating to the Open Payments Program." Sunshine Alert, May 22, 2013
    • Co-author with Benjamin Koplin and Selina Coleman, "Request for Comments; Data Templates and Teaching Hospital List Available," Fulbright's Sunshine Act Task Force, May 3, 2013
    • Co-author with Benjamin Koplin and Selina Coleman, "FAQs Released for Sunshine Act," Sunshine Forecast, April 12, 2013
    • Co-author with Benjamin Koplin and Selina Coleman, "The Other Side of the Sunshine Act: Reporting Ownership & Investment Interests," Sunshine Forecast, March 21, 2013
    • Co-author with Benjamin Koplin and Selina Coleman, "Reporting 'Indirect Payments' Under the Sunshine Act: A Closer Look," Sunshine Act Forecast, March 4, 2013
    • Co-author with Benjamin Koplin and Selina Coleman, "Tracking Payments: How Should Manufacturers Allocate Food and Beverages?," Sunshine Act Forecast, February 13, 2013
    • Co-author with Benjamin Koplin and Selina Coleman, "Highlights of the Sunshine Act's Final Rule Part 1: Key Changes and Clarifications," Sunshine Act Forecast, February 4, 2013
    • Co-author with Benjamin Koplin and Selina Coleman, "Still No Sunshine," Sunshine Forecast, January 11, 2013
    • Co-author with Benjamin Koplin and Selina Coleman, "Department Of Health And Human Services Submits Sunshine Act Rules to OMB for Review," "Sunshine" Alert, November 30, 2012
    • Co-author with Rod Lambert and Frederick Robinson, "Comment Period Opens for EU Proposed Framework on Medical Device Regulation," Fulbright Briefing, November 29, 2012
    • Co-author with Benjamin Koplin and Selina Coleman, "Massachusetts Posts Final Rules on 'Modest Meals' and Reporting Requirements," "Sunshine" Forecast, November 29, 2012
    • Co-author with Selina Coleman and Benjamin Koplin, "Reporting Under The Sunshine Act: Still In The Dark," Law360.com, Oct. 4, 2012
    • Co-author with Benjamin Koplin and Selina Coleman, "How Will Physicians/Teaching Hospitals Review the Collected Data and Resolve Disputes?," Fulbright's Sunshine Act Task Force, August 29, 2012
    • Co-author with Benjamin Koplin and Selina Coleman, "Challenges to Reporting Physician Ownership and Investment Interests," Fulbright's Sunshine Act Task Force, May 7, 2012
    • Co-author with Benjamin Koplin and Selina Coleman, "CMS Delays Final Rulemaking Until Later This Year; Will Not Require Data Collection or Reporting Until 2013," Fulbright Alert, May 4, 2012
    • Co-author with Benjamin Koplin and Selina Coleman, "Who Reports Transfers of Value?," Fulbright's Sunshine Act Task Force, April 30, 2012
    • Co-author with Benjamin Koplin and Selina Coleman, "Industry Continues to Await Sunshine Act's Final Rules," Fulbright's Sunshine Act Task Force, April 23, 2012
    • Co-author with Benjamin Koplin and Selina Coleman, "CMS Publishes Long-Awaited Proposed Regulations to the Sunshine Act," Fulbright Alert, December 15, 2011
    • Co-author with Benjamin Koplin and Selina Coleman, "CMS Responds to Letters on Missed Deadline for Sunshine Act; Avoids Promising Release Date for Overdue Regulations," Fulbright & Jaworski L.L.P. Briefing, November 3, 2011
    • Co-author with Benjamin Koplin and Selina Coleman, "CMS Misses Sunshine Act Deadline; Industry Awaits CMS Comment, Regulations," Fulbright & Jaworski L.L.P. Briefing, October 5, 2011
  • Licenses
    • Washington D.C. Bar License
    • Texas State Bar License