Laboratories nationwide are overwhelmed with increased diagnostic testing volume while simultaneously managing regulatory changes in light of the COVID-19 pandemic. It is more essential than ever for clinical laboratories to enforce regulation, have a compliance plan in place and develop or enhance operational policies. Our firm has legal lab experts with ‘insider’ healthcare business knowledge to help keep your business compliant while adapting to the rapidly changing healthcare landscape.
- Laboratory regulatory compliance & operations
- Laboratory compliance programs & plans
- Laboratory licensure, accreditation & certification
- Lab billing, reimbursement, charge-master review, CPT, ICD-10, HCPC coding & audits
- Education & training programs designed for OIG compliance
- General Counsel on per project basis for independent clinical labs or physician-owned labs
- Requisition form revisions, testing menu expansion for COVID-19
A laboratory compliance program is an essential tool that should be designed to:
- Give ownership and staff a working understanding of the law;
- Provide a framework for the laboratory to comply with applicable laws; and guide your laboratory through a process when a compliance issue arises in order to bring that issue to resolution.
The OIG has published Compliance Program Guidance documents for various kinds of healthcare providers, including laboratories. The areas of focus and legal basis for developing a laboratory compliance program are found in the Social Security Act (Medicare and Medicaid), Anti-kickback Statute (AKS), False Claims Act (FCA), Physician Self-Referral Act (Stark), Health Insurance Portability and Accountability Act (HIPAA) and Eliminating Kickback in Recovery Act (EKRA). With this many regulations, laws, ethical business practices and standards to consider, staying in full compliance requires diligent efforts and the support of a highly skilled team.
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