With deep experience at the intersection of health care law and litigation, Kara Sweet advises health care providers, suppliers, and companies across the health care industry. Clients come to Kara when they have compliance questions, internal investigations, or government investigation and enforcement actions, including matters involving the False Claims Act (FCA), Anti-Kickback Statute (AKS), and Stark Law. Kara is known for being responsive and practical鈥攈elping clients make defensible decisions under tight timelines. She is valued for her ability to quickly master complex factual and regulatory frameworks and deliver practical, actionable guidance tailored to clients鈥 business needs.
Representative Experience
Health Care Litigation and Internal Investigations
Kara has represented companies, including medical devices companies, laboratories, and other health care industry participants, in investigations and litigation initiated by the federal government, state agencies, and whistleblowers. Kara has experience not only in the FCA and state FCA, but also in the AKS and Stark Law. She analyzes, investigates, and litigates these statutes, and has helped clients secure early case resolutions, including successful motions to dismiss and appellate affirmances.
- Represented a laboratory company in FCA and AKS matter alleging improper kickbacks in exchange for referrals.
- Assisted a large health care entity responding to a civil investigative demand (鈥淐ID鈥) related to alleged COVID-19 fraud.
- Provided health care counsel to a medical equipment company responding to DOJ allegation of FCA violation related to Medicaid reimbursement fraud.
- Represented a provider group in a FCA, Stark Law, and AKS matter alleging improper contracting to induce referrals.
- Achieved dismissal of a FCA qui tam action on behalf of a hospital, and successfully defended the result on appeal鈥攕ecuring an appellate affirmance that fully resolved the matter for the client.
- Led an investigation and response to a state attorney general inquiry related to fair patient billing practices on behalf of a children鈥檚 hospital, recommending process improvements to strengthen future compliance.
- Successfully challenged a Medicaid overpayment determination on behalf of a national durable medical equipment company, identifying procedural and substantive deficiencies and negotiating a favorable settlement that significantly reduced the client鈥檚 financial exposure.
Health Care Compliance and Regulatory
Kara has advised large hospital and health systems, physician practice groups, and pharmacies on wide ranges of federal and state health care regulatory compliance.
- Keeping various clients informed of COVID-19 related requirements and waivers, including CMS鈥 Hospital without Walls and Hospital at Home programs, Provider Relief Funds (PRF), and federal and state vaccination mandates.
- Advising health care entities on state regulatory issues including state licensing and change of ownership.
- Counseling physician and other clinician practices on the corporate practice restrictions on their professions.
- Guided health care clients through a broad range of transaction matters, including mergers and acquisitions, affiliations, and formation of friendly professional corporations.
- Managed a portfolio of internal concern report investigations for a national durable medical equipment company while seconded to the client, including conducting witness interviews, analyzing policies and procedures, and presenting findings and recommendations to client leadership.
- Conducted risk assessments involving review of payor contracts and plan materials to evaluate regulatory compliance risks for health care clients.
Affiliations
- Member, American Health Lawyers Association (AHLA)
Presentations and Publications
- Co-author, “Medicare Advantage: A Circuit Court Addresses What is (or is not) Material in False Claims Act Cases,” Health Care Law Today聽(September 18, 2024)
- Co-author, “Court Calls Underlying Legal Standards 鈥淣o Model of Clarity鈥 but Allows False Claims Act Case To Proceed Anyway,”聽Health Care Law Today聽(January 11, 2023)
- Co-author, “FCA Managed Care Case Update: A Court鈥檚 View of ICD Guidelines in Risk Adjustment Cases,”聽Health Care Law Today聽(December 27, 2022)
- Co-author, 鈥淣ew Jersey Allows Asynchronous Telemedicine,鈥 Health Care Law Today (January 6, 2022)
- Co-author, 鈥淩ed Light 鈥 Green Light: CMS Vaccination Mandate is On Again in 26 States?鈥 Health Care Law Today (December 15, 2021)
- Co-author, 鈥淐MS Requires Self-Disclosure Protocol: Top Takeaways,鈥 Health Care Law Today (November 9, 2021)
- Co-author, 鈥淣ew Jersey鈥檚 Telemedicine Business Registry: What You Need to Know,鈥 Health Care Law Today (September 1, 2021)
- Co-author, 鈥淐hapter 9: The Alphabet Soup of Medicare and Medicaid Contractors,鈥 American Bar Association鈥檚 Physician Law: Evolving Trends & Hot Topics 2021 (July 26, 2021)
- Co-author, 鈥淐MS to Permanently Cover Audio-Only Telemedicine for Mental Health,鈥 Health Care Law Today (July 21, 2021)
- Co-author, 鈥淔rom Petri Dish to Main Dish: The Legal Pathway for Cell-Based Meat,鈥 The Kentucky Journal of Equine, Agriculture, & Natural Resources Law (June 2021)
- Contributing author, 鈥淭he risks of 鈥榮wapping鈥 for durable medical equipment,鈥 McKnight’s Long-Term Care News (April 14, 2021)
- Co-author, 鈥淐OVID-19 Food & Beverage Regulatory Updates,鈥 Coronavirus Resource Center: Back to Business (September 8, 2020)
- Co-author, 鈥淐OVID-19: Free Lodging, Free Testing, Free of OIG Enforcement?鈥 Coronavirus Resource Center: Back to Business (August 10, 2020)
- Co-author, 鈥淐OVID-19 Food & Beverage Regulatory Updates,鈥 Coronavirus Resource Center: Back to Business (July 27, 2020)
- Co-author, 鈥淔DA Increases Scrutiny of COVID-19 Serology Tests: What Commercial Manufacturers Need to Know,鈥 Coronavirus Resource Center: Back to Business (May 6, 2020)
- Co-author, 鈥淢eat and Poultry Industry Gets New COVID-19 Guidance from CDC and DOL,鈥 Coronavirus Resource Center: Back to Business (April 28, 2020)
- Co-author, 鈥淚mplications for the Cannabis Industry Due to the Coronavirus,鈥 Coronavirus Resource Center: Back to Business (April 17, 2020)
- Co-author, 鈥淐OVID-19: Idaho Governor Suspends More Regulations Relating to Telehealth and Medical Licensing,鈥 Coronavirus Resource Center: Back to Business (April 13, 2020)
- Co-author, 鈥淔DA Publishes Enforcement Policies to Address Coronavirus Personal Protective Equipment Shortages,鈥 Coronavirus Resource Center: Back to Business (April 6, 2020)
- Co-author, 鈥淢anaging the Commercial Impact of the Coronavirus: Food & Beverage,鈥 Coronavirus Resource Center: Back to Business (March 6, 2020)
- Co-author, 鈥淭elehealth: Massachusetts鈥 Proposed Act to Improve Health Care by Investing in Value,鈥 Health Care Law Today (January 29, 2020)
- Contributor, “Key Takeaways from USDA’s Interim Hemp Production Rule,” 麻豆传媒 Insights (November 1, 2019)
The Evolving Landscape of Insurance Coverage for False Claims Act (FCA) Probes: Understanding the Impact of a Delaware Court Ruling
Companies operating in heavily regulated industries are becoming increasingly familiar with Department of Justice (DOJ) Civil Investigative Demands (CID). Traditionally viewed as a pre鈥憇uit investigative tool, a CID may require collecting, reviewing, and producing documents; preparing for and attending witness interviews; or meeting and negotiating with DOJ.
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How Following 鈥淒octors鈥 Orders鈥 Provided a Defense in a First Circuit FCA Case
When it comes to False Claims Act (FCA) litigation, clinical laboratories often find themselves in the crosshairs. But the First...
Anti-Kickback Statute Premised False Claims Cases: The 鈥淏ut For鈥 Causation Standard Finds Support from First Circuit
It鈥檚 now 3鈥1, with the First Circuit (2025) aligning with the Sixth (2023) and Eighth (2022) Circuits finding the meaning of the words 鈥渞esulting from鈥 鈥 as used in a 2010 amendment to the federal Anti-Kickback Statute 鈥 to require 鈥渂ut for鈥 causation in AKS-premised False Claims Act cases.
Medicare Advantage: A Circuit Court Addresses What is (or is not) Material in False Claims Act Cases
On September 13, 2024, the United States Court of Appeals for the Eighth Circuit鈥檚 published its much-anticipated decision in United States ex rel. Holt v. Medicare Medicaid Advisors, affirming the Western District of Missouri鈥檚 dismissal of a Medicare Advantage case 鈥 a win for managed care stakeholders, especially insurance carriers, insurance brokers, and insurance marketing organizations.
The No Surprises Act: The Departments Proposed Another Increase to IDR Fee, Will it Stick?
On September 26, 2023, the Departments of Health & Human Services, Labor, and the Treasury jointly proposed rules updating the administrative fee and Certified Independent Dispute Resolution entity fee ranges for the Federal IDR Process under the No Surprises Act.
A Year After the No Surprises Act: What We've Learned and What to Watch Out For
麻豆传媒 partner Nick Welle, chair of the firm鈥檚 Health Benefits Practice, and associates Alexandra Shalom and Kara Sweet are hosting an informative CLE webinar on September 28, covering how the NSA has affected the health care industry a year after going into effect.