A wide range of complex legal and regulatory issues govern the operations and practices of clinical laboratories, ensuring the labs stand up to stringent standards set forth by various entities. The healthcare law team at Norman Spencer & Associates is extensively familiar with these issues, providing the exact type and level of legal assistance our clinical lab clients need.

We help both physician-owned clinical laboratories and independent laboratories maneuver through the complicated landscape surrounding clinical labs to best protect their businesses and themselves.

Our clinical laboratory compliance attorneys assist with a variety of compliance issues in the industry. These can include compliance with the federal anti-kickback statute and Stark law, as well as FDA compliance and HIPAA compliance.

Compliance with clinical research contracts and institutional review boards is also on our list of services, as is compliance and certification with the Clinical Laboratory Improvement Amendments (CLIA).

We help our clinical laboratory clients with Medicare and Medicaid participation issues, as well as a wide scope of audits and appeals related to Medicare, Medicaid and other entities. These include audits and appeals may be associated with private payors, Medicare administrative contractors (MAC), recovery audit contractors (RAC), and ZPIC.

Clinical lab marketing and labeling matters are within our purview, as are state licensure issues. Marketing and labeling must be done with acute care, as even the slightest omission or error can result in problematic legal issues. Specific information must be included, and information may neither be deceptive nor misleading.

New York is one of several states that require laboratory personnel licensure. Maintaining a current license is imperative, as is adhering to all provisions for continuing education and meeting all professional competency requirements. Clinical lab personnel licensure in New York state is granted for life, with registration fees paid every three years.

Clinical labs are subject to bastion of federal regulations, another area where Norman Spencer & Associates have helped numerous clients. The Office of Inspector General (OIG) is a major player in these regulations, particularly with the OIG Compliance Guidance for Clinical Laboratories. Here the OIG outlines and clarifies the risk areas clinical labs face, while suggesting steps you can take with your compliance program to ensure everyone is done in accordance with the specified requirements.

Main risk areas outlined by the OIG include:

Billing: Billing is one of the most important compliance areas, as billing practices must align with stringent requirements. Clinical laboratories must pay strict attention to billing codes, such as HCPCS, CPT, and ICD-9-CM. These codes are designed to describe the specific service that was ordered and performed, and they must be properly used. Clinical labs must also be careful not to bill for both calculations and test performed to arrive at the calculations. This practice is prohibited.

Medical Necessity: Lab Guidance directives require clinical laboratories to take proactive steps to ensure physicians only order tests that are medically necessary. One tactic labs can use to achieve this is modifying their requisition forms to gather the proper information. It’s also essential to verify medical codes submitted by physicians for accuracy. Another step labs can take is to include provisions within their compliance plans that outline the correct use of test utilization monitoring and Advance Beneficiary Notices.

Reliance on Standing Orders: While clinical labs are permitted to use standing orders, the OIG demands these orders be monitored. Standing orders need to have a fixed term of validity that requires renewal once expired.

Fraud Alert Compliance: The OIG mandates that clinical labs must regularly review and follow fraud alerts issued by the government.

Marketing Practices: Clinical laboratory marketing must be honest and non-deceptive. Clinical lab compliance plans needs to include policies that ensure this is always the case.

Prices Charged to Physicians: Clinical labs must take steps to avert potential issues with prices they charge physicians. Charging prices below fair market value, for instance, could possibly be perceived as providing inducement to gain a physician’s business.

Medicare and Medicaid audits, investigations and appeals are regular occurrences for both independent and physician-owned clinical laboratories. Norman Spencer & Associates have notable experience handling these audits and appeals utilizing seasoned attorneys and winning legal strategies. As each clinical laboratory has unique issues, our healthcare attorneys work side-by-side with our clinical lab clients to devise the most effective strategy for an audit defense.

The appeals strategies we use have helped decrease the financial burden clinical laboratories face. Our healthcare lawyers work hard to mount a powerful defense mechanism designed to help you face challenges with confidence.

Supply chain and purchasing activities are another area where clinical labs often seek out legal counsel. Our healthcare lawyers have knowledge and experience in the area, along with a deep understanding of the regulatory environment affecting supply chain operations. We can help clinical laboratory clients with matters related to the purchase of devices, services and laboratory equipment.