Healthcare Regulatory and Compliance
Corporate compliance is the cornerstone of our health law practice. With our vast experience, we work with clients to develop and implement risk-management programs and guidance that help create an effective compliance culture. From conducting Stark Law and Anti-Kickback Statute audits and analyses, to helping align compliance and business strategies, we regularly advise on the full range of federal and state regulatory matters, including in these core areas:
State and Federal Licensing and Certification
Our lawyers work with clients to ensure that they meet all licensing, certification and accreditation requirements associated with:
- Certificates of need
- Provider licensure
- Reimbursement and audits
- State and federal surveys, corrective action plans, reconsideration requests and appeals
- Policy Development
- Quality assessment and performance improvement
- Peer review
- Tax-exempt status
- Medical staff bylaws and disciplinary matters
- Corrective action plans
- 340B reimbursement
- Research compliance, including informed consent, institutional review board (IRB) activities, and sponsor and investigator agreements
- Patient experience issues
- Medical ethics
- Privacy
Medicare and Medicaid Reimbursement
We regularly advise our health care provider clients on the full range of Medicare and Medicaid reimbursement issues, including matters that involve offices of state attorneys general, the US Department of Health and Human Services (HHS) Office of the Inspector General (OIG), and the US Attorney. Among other areas, we help clients:
- Respond to Medicaid and Medicare audits
- Defend whistleblower claims of fraud and abuse
- Negotiate settlements with applicable regulatory and law-enforcement agencies
Certificate of Need
Our attorneys have extensive experience advising clients on the certificate of need (CON) process and issues arising from formation of new facilities, changes in ownership, joint ventures and termination of services, among other areas. We have worked with numerous clients in their interactions with the Connecticut Office of Health Strategy and play an active role in:
- Assisting in the preparation of the CON application
- Representing providers, as applicants or interveners in the administrative proceeding and hearings
Health Care Administrative Disputes
We help clients preemptively identify, address and prevent potential disputes. When unforeseen events do arise, such as agency audits and investigations, our attorneys provide effective legal representation with an eye toward minimizing exposure and negotiating an effective resolution. We have represented clients before a number of state and federal agencies, including the:
- US Department of Health & Human Services Office of Inspector General
- US Department of Justice
- US Health Resources & Services Administration
- Connecticut Attorney General’s Office
- Connecticut Office of Health Strategy
- Connecticut Department of Public Health
- Connecticut Department of Social Services
We regularly handle investigations and hearings, prepare corrective action plans and negotiate consent orders on behalf of healthcare facilities and providers.
