Samantha Roth

Health care regulatory and compliance guidance with an in-house perspective

Samantha Roth assists health care entities such as hospitals, health systems and critical access hospitals in navigating a wide variety of regulatory and compliance matters. She also represents pharmacies, including specialty, compounding, mail order, pharmacy wholesalers and third-party logistics providers (3PL), with nationwide licensing and permitting requirements. Sam’s experience includes:

• Advising hospitals on constantly evolving telemedicine regulations.
• Analyzing requirements for Health Insurance Portability and Accountability Act (HIPAA) compliance.
• Establishing guardianships and protective placements.

Prior to joining the firm, Sam was a risk management legal intern for the Medical College of Wisconsin, where she researched health law issues impacting the hospital, doctors and patients. She also worked for a pharmaceutical research company as a quality assurance officer, verifying study compliance to Food and Drug Administration (FDA), Environmental Protection Agency (EPA) and international regulations.

Through pro bono work, Sam supports Heartland Alliance’s National Immigrant Justice Center, helping establish Special Immigrant Juvenile Status (SIJS) for immigrant children who have experienced abuse, neglect or abandonment by their parents.

• Analyzes and ensures compliance with the Medicare conditions of participation (CoP) and The Joint Commission (TJC) Accreditation Standards for hospitals and critical access hospitals.
• Reviews tax exempt hospital organizations’ compliance with 501(r) regulations, including advising on the Internal Revenue Service (IRS) requirements for community health needs assessments (CHNA), financial assistance policies, limitation on charges, and billing and collections, as well as developing correction plans for non-compliance.
• Works with hospitals to develop delegated credentialing policies and procedures consistent with National Committee for Quality Assurance (NCQA) and URAC requirements.
• Advises pharmaceutical clients on nationwide pharmaceutical licensing requirements for resident and non-resident pharmacies, wholesalers, 3PLs and manufacturers.
• Manages multi-state change of ownership (CHOW), change of name, change of officers and de novo licensing initiatives for pharmaceutical entities.