Jana Kolarik

Practice Areas

Corporate, False Claims Act, Government Enforcement Defense & Investigations, Health Care, Health Care Regulatory, Health Care Transactions

Career

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 clients 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 HHS 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, including health systems, hospitals, physician groups, durable 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.

Professional Memberships

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

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.

Education