Clinical Laboratory Compliance Specialists
Regulatory Solutions Group has spent 25+ years inside the most demanding compliance environments in healthcare — including clinical laboratories facing medical necessity audits, CLIA scrutiny, and False Claims Act exposure. We don't just advise. We've done the work.
Clinical laboratories operate in one of the highest-risk compliance environments in healthcare. Medical necessity documentation, ordering physician relationships, test utilization patterns, CLIA requirements, and OIG enforcement priorities create a web of exposure that generic compliance consultants simply don't understand.
the OIG's "Measuring Compliance Program Effectiveness" guide — the definitive federal resource for lab compliance programs
successful exits from OIG Corporate Integrity Agreements, with the OIG specifically praising our whistleblower engagement strategy
proprietary risk assessment methodology as a best practice in the HCCA's Complete Healthcare Compliance Manual
in private equity transactions supported, including laboratory and healthcare services businesses
Every engagement is led personally by Barb Senters, CCEP, CHC, PHR — no hand-offs to junior staff.
On-demand Chief Compliance Officer leadership for labs navigating transitions, rapid growth, or regulatory scrutiny. We provide experienced oversight of OIG compliance program elements, medical necessity policies, and lab-specific billing compliance — without the cost of a full-time executive hire.
Especially critical when a lab is under MAC audit, responding to an OIG inquiry, or scaling operations faster than internal compliance can keep pace.
Build or transform your GRC program from the ground up — or strengthen an existing one. For laboratories, this includes medical necessity frameworks, CLIA compliance infrastructure, billing and coding policies, and training programs aligned with OIG guidance and False Claims Act requirements.
We build programs that hold up under OIG review — not just on paper, but in practice.
Comprehensive, risk-based assessments that identify compliance gaps and prioritize remediation. For clinical labs, this means targeted review of medical necessity documentation, ordering physician relationships, test utilization patterns, and billing practices — benchmarked against OIG work plan priorities and current enforcement trends.
Our proprietary methodology is published as a best practice by the Health Care Compliance Association.
Strategic guidance for organizations under regulatory oversight — including OIG Corporate Integrity Agreements, DOJ investigations, MAC audits, RAC audits, and other enforcement actions. We led the successful exit of a CIA that the OIG specifically praised for its innovative whistleblower engagement strategy.
If you're already in the crosshairs, this is where our track record matters most.
Qualified expert witness testimony and analysis in complex compliance, fraud, and regulatory matters — including False Claims Act cases, medical necessity disputes, and laboratory billing litigation. We bring deep subject matter expertise and a credible track record to litigation and dispute resolution engagements.
Retained in FCA cases, medical necessity disputes, and lab billing litigation nationwide.
Compliance-focused due diligence and post-close integration support for mergers, acquisitions, and private equity transactions. We have supported deals exceeding $1.5 billion, including transactions involving laboratory and healthcare services businesses where billing compliance and regulatory exposure are central to deal risk.
Lab acquisitions carry hidden compliance risk. We surface it before it becomes your problem.
Executive-ready compliance reporting, board presentations, and advisory services that translate complex regulatory risk into clear, actionable intelligence for leadership and governance bodies — including lab owners, PE-backed management teams, and public company boards.
Boards need to understand lab compliance risk in plain language. We make that happen.
End-to-end compliance program design and SEC readiness support for companies preparing to go public. We built and guided Core Scientific's GRC program through rigorous SEC scrutiny ahead of its Nasdaq launch — the same structured approach applies to healthcare and lab companies on a public company path.
Lab companies going public face unique compliance disclosure requirements. We've navigated them.
Whether you're building a program from scratch, responding to an audit, preparing for a transaction, or already under OIG oversight — Regulatory Solutions Group delivers the expertise clinical laboratories need.