Jana L. Kolarik
Partner
Jana L. Kolarik
Partner
Jana Kolarik’s deep understanding and unique experience with Federal and State health care regulatory requirements, Anti-Kickback Statute risks, and Stark Law issues helps clients further safeguard their arrangements in the health care and life sciences sector.
Clients trust Jana to recommend compliance strategies to manage risk, including –
- advising on compliant compensation and ownership models,
- working with client to address coding, coverage and payment issues affecting claims and repayment obligations,
- structuring corporate compliance effectiveness reviews and implementing compliance program changes,
- providing health care regulatory due diligence advice on transactions, and
- assisting on Office of Inspector (OIG) and Centers for Medicare & Medicaid Services (CMS) voluntary self-disclosures.
She has also served as a Compliance Expert and Legal Independent Review Organization (IRO) for different OIG Corporate Integrity Agreements (CIAs).
Jana represents a broad range of organizations in the health care and life sciences sector, which includes health systems, hospitals, physician groups, home medical equipment suppliers and device manufacturers, as well as investors in health care entities. Jana is a member of the firm’s Health Care Practice Group and Government Enforcement, Defense & Investigations Practice Group.
Representative Experience
- Counsels in-house counsel, compliance officers and executive teams on structuring compliance programs and addressing health care compliance issues (e.g., fraud and abuse-related, licensure, claims-related).
- Counsels clients on how to structure compensation and ownership arrangements in compliance with the Anti-Kickback Statute and Stark Law.
- Structures corporate compliance effectiveness reviews and advises on recommended compliance program implementation and changes.
- Advises on claims-related issues including statistical sampling, extrapolation and repayment recommendations for providers and suppliers.
- Assists on OIG and CMS voluntary self-disclosures.
- Counsels clients on compliance with coding, coverage and payment rules.
- Acts as Compliance Expert for a clinical laboratory pursuant to its OIG CIA.
- Provides health care regulatory due diligence advice on buy-side and sell-side transactions for a wide range of providers and suppliers.
- Acted as a Legal IRO for a hospital’s OIG CIA for five years.
Awards and Recognition
- Peer review rated as AV Preeminent®, the highest performance rating in Martindale-Hubbell® Peer Review Ratings™ system
- Selected by her peers for inclusion in The Best Lawyers in America© in the field of Health Care Law (2018 – 2024)
- Named the Best Lawyers® Health Care Law “Lawyer of the Year” in Jacksonville (2022, 2024)
- Voted by her peers and selected as a member of Florida Trend’s Florida Legal Elite™ group (2020)
Affiliations
- Hope Haven (board of directors)
- Member, American Health Lawyers Association
- Member, Health and Business Law Sections of the American Bar Association
- Member, District of Columbia Bar Association and the Florida Bar Association
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 (September 18, 2024)
- Author, “Compliance Compass: The Erlanger Complaint – A Cautionary Reminder About the Importance of FMV,” Health Care Law Today (August 12, 2024)
- Quoted, “Compliance Requirements Continue to Change, Need Close Attention,” Relias Media News (May 1, 2024)
- Author, “CMS Changes Medicare Advantage and Part D Plans’ Agent/Broker/TPMO Compensation Landscape,” Health Care Law Today (April 22, 2024)
- Co-Presenter, Health Care Compliance Association’s (HCCA) 28th Annual Compliance Institute, “Stark Law & Valuation: Fixing Problematic Structures” (April 16, 2024)
- Author, “’Let’s Talk Compliance’: Hot Topics in Compliance,” Health Care Law Today (February 16, 2024)
- Author, “Medicare Advantage and Part D Final Rule Affects Marketing and Sales Landscape for Not Only MA Plans and PD Sponsors, but also TPMOs and FDRs,” American Health Lawyers Association (AHLA) RAP Practice Group Bulletin (April 25, 2023)
- Moderator, 5th Annual “Let’s Talk Compliance” Foley & PYA Virtual Conference (January 19-20, 2023)
- Co-Presenter, “State of the Health Care Industry – Compliance and Enforcement,” 5th Annual “Let’s Talk Compliance” Foley & PYA Virtual Conference (January 19, 2023)
- Co-Presenter, “Speaking of Health Law” American Health Law Association (AHLA) Podcast, “The Impact of Split-Shared and Other Billing Concepts on Fair Market Value” (December 13, 2022)
- Quoted, “Stark Law changes: Physician compensation arrangements to keep an eye on,” Becker’s ASC Review (September 22, 2022)
- Co-presenter, “Let’s Talk Compliance” Event – Stark Law Changes and Impact on Physician Compensation Part 2, Foley & PYA Webinar (September 13, 2022)
- Author, “Stark Law Changes: Hospitals Need to Revisit Physician Compensation Arrangements” Health Care Law Today (September 6, 2022)
- Author, “Regulatory Compliance & Physician Compensation Arrangements, Part II” Bloomberg Law Today (August 3, 2022)
- Co-author, “OIG Special Fraud Alert on Arrangements with Telemedicine Companies” Health Care Law Today (July 20, 2022)
- “Let’s Talk Compliance” Event – Recent Regulatory Changes Require Fresh Look at Physician Compensation, Foley & PYA Webinar (June 9, 2022)
- Author, “Regulatory Compliance & Physician Compensation Arrangements” Bloomberg Law (June 8, 2022)
- Co-author, “Health Care & Life Sciences Sector Top Trends for 2022” Health Care Law Today (May 4, 2022)
- Co-host, “Let’s [Virtually] Talk Compliance | A Foley & PYA Master Class” Foley & PYA Event (January 19-20, 2022)
- Co-presenter, “Let’s [Virtually] Talk Compliance | A Foley & PYA Master Class” – Session #2 Compliance Considerations Related to Provider Compensation (January 19, 2022)
- Co-presenter, “Episode 17: Let’s Talk Compliance (Again!) – An Update on Fair Market Value & Commercial Reasonableness” (August 19, 2021)
- Co-presenter, “Everything You Always Wanted to Know About Sales Practices – the Dos, the Maybes, and the Don’ts-But Have Been Afraid to Ask,” ACC Health Law Network Webinar (July 1, 2021)
- Presenter, “Stark Law & Anti-Kickback Statute Regulatory Changes 2021,” ACC Health Law Network Webinar (May 4, 2021)
- Co-author, “Bipartisan Leadership of House Committee of Energy and Commerce and its Health Subcommittee Urge HHS Secretary Becerra to Vigorously Enforce Compliance with the Hospital Price Transparency Rule,” Health Care Law Today (April 21, 2021)
- Quoted, “Stark Law Revisions Take Effect for Hospice, Other Health Care Providers,” Hospice News (February 3, 2021)
- Co-host and Presenter, Let’s [Virtually] Talk Compliance | A Foley & PYA Master Class – “Physician Compensation: Hot Topics,” (January 22, 2021)
- Author, “Key Takeaways from the Revised and Clarified Stark Law Regulations – Part 2,” Health Care Law Today (January 22, 2021)
- Author, “Key Takeaways from the Revised and Clarified Stark Law Regulations – Part 1,” Health Care Law Today (January 21, 2021)
- “Physician Contracts and the Stark Law/Anti-kickback Backdrop,” APSMA Physician Compensation Mini Conference (November 10, 2020)
- “Bad Facts and Qui Tam: FMV and CR in the Eye of the Beholder,” American Bar Association’s (ABA’s) Physicians Legal Issues: Healthcare Delivery & Innovation (September 21-25, 2020)
- “Physician Contracts and the Stark Law/Anti-kickback Backdrop,” APSMA Physician Compensation Mini Conference (November 10, 2020)
- Co-author, “Key Takeaways from Executive Order on Surprise Billing,” Health Care Law Today (October 6, 2020)
- Co-presenter, “Bad Facts and Qui Tam: FMV and CR in the Eye of the Beholder,” American Bar Association’s Physicians Legal Issues: Healthcare Delivery & Innovation (September 25, 2020)
- Co-presenter, “FMV and Commercial Reasonableness Challenges,” Strafford CLE Webinar (August 4, 2020)
- “Surprise Billing – Not the Kind of Surprise You Want!,” Association of Corporate Counsel Health Law Network Legal Quick Hit (August 4, 2020)
- Author, “Welcome Changes to Florida’s Patient Brokering Act,” Health Care Law Today (July 7, 2020)
- Author, “EKRA and Florida’s Patient Brokering Act: Clarification Needed Amid Uncertainty,” Health Care Law Today (February 18, 2020)
- Author, “Compliance: Top Takeaways from Foley and PYA’s Annual ‘Let’s Talk Compliance’ Event,” Health Care Law Today (February 11, 2020)
- “Navigating Overpayments,” Florida Hospital Association’s 2020 Health Care Corporate Compliance Roundtable Event (February 6, 2020)
- “Let’s Talk Compliance” Event – Overpayments Presentation, Foley & PYA Event in Orlando (January 24, 2020)
- Co-presenter, “Episode 3: Let’s Talk Compliance: Breaking Down Fair Market Value and Commercial Reasonableness,” Health Care Law Today (October 9, 2019)
- Co-author, “Health Care MarketTrends | September 2019, Issue 2,” Health Care Law Today (September 16, 2019)
- Co-author, “Florida: Changes to the State Patient Brokering Act,” Health Care Law Today (August 16, 2019)
- “Best Practice Scenarios for Internal Investigations and Audits,” Florida Hospital Association’s 16th Annual Health Care Corporate Compliance Education Retreat (June 13, 2019)
- “Fair Market Value and Commercial Reasonableness – Stark Law & Regulatory Risks,” Florida Institute of CPAs (April 26, 2019)
- “The Anatomy of Incident-to and Split/Shared Billing,” AHLA Physicians & Hospitals Law Institute (February 4-6, 2019)
- “Let’s Talk Compliance” Event – Overpayments and Internal Audit/Investigation Presentations, Foley & PYA Event in Jacksonville (January 25, 2019)
- Co-author, “The Importance of Diligence in Orthopedic Recapitalization Transactions,” Health Care Law Today (January 4, 2019)
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’s published its much-anticipated decision in United States ex rel. Holt v. Medicare Medicaid Advisors, affirming the Western District of Missouri’s dismissal of a Medicare Advantage case — a win for managed care stakeholders, especially insurance carriers, insurance brokers, and insurance marketing organizations.
Episode 34: “Let’s Talk Compliance”: Health Care Organizations Take Note: Trends and Pitfalls in the Bond Market Compliance Space
In this episode, partner Jana Kolarik of Foley’s Health Care Practice Group and PYA principal Angie Caldwell host Heidi Jeffery, a partner in Foley’s Finance and Financial Institutions Practice Group and Matt Stuart, a Principal in PYA’s Audit Assurance Service Line, discuss the latest trends in the bond market and the bond compliance pitfalls that organizations should avoid.
Compliance Compass: The Erlanger Complaint – A Cautionary Reminder About the Importance of FMV
Although most health care lawyers and compliance officers who review and analyze physician compensation understand that fair market value (FMV) is important, the nuances around FMV are sometimes missed.
Episode 33: Let’s Talk Compliance: What the July 3rd Ruling on FTC Non-Compete Ban Means for the Health Care Industry
In this episode, Benjamin Dryden, vice chair of Foley’s Antitrust & Competition Practice Group and David McMillan, managing principal of consulting and chief financial officer at PYA, discuss the recent July 3rd ruling on the U.S. Federal Trade Commission’s Non-compete Ban and how this will affect the health care & life sciences industry.
Episode 32: Let’s Talk Compliance: What the FTC’s Ban on Non-Competes Means for the Health Care Industry
In this episode, Benjamin Dryden, vice chair of Foley’s Antitrust & Competition Practice Group and David McMillan, managing principal of consulting and chief financial officer at PYA, discuss the FTC’s most recent decision to ban non-competes and how this ban will affect the health care & life sciences industry.
Jana Kolarik on Health Care Compliance, AI
Foley & Lardner LLP partner Jana Kolarik emphasizes the importance of staying on top of recent changes in rules and enforcement priorities in the Relias Media article, "Compliance Requirements Continue to Change, Need Close Attention."