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Lawyers for Clinical Laboratories

June 18, 2016

With all the strict guidelines, rules, and regulations that are created for clinical laboratories, it is easy to see why they need a lawyer. When tracking, billing, marketing, and managing all must be considered, there are a number of reasons that a clinical laboratory may need legal assistance. In order to ensure that the laboratory is compliant with all the rules and regulations set out in front of them, the head of the lab will want to connect with an expert lawyer.

Here are some of the ways that a clinical lab may need an attorney’s assistance and what an expert legal team can do to help.

Avoid Risk

A clinical laboratory faces a number of different risks, all that could compromise the wellbeing of the lab and those who work there. When you are considering the tests done in a clinical lab and how personal those may be, anyone working within in a clinical lab will want to ensure that privacy of the patients is maintained and that the doctors ordering the tests do not overstep their boundaries.

A lawyer can help everyone at the clinical laboratory understand what needs to be done to keep the area running smoothly. An expert legal team can walk the laboratory through the OIG’s Compliance Guidance for Clinical Laboratories and ensure that each individual working in the lab does not cause any problems or issues.

The following areas are the main risks that a clinical laboratory may face:


The marketing of the lab must be honest and not push false or unrealistic claims. Through the compliance policy for clinical laboratories, the marketing efforts and practices done by the lab must not be deceptive. An expert attorney and their team can help determine if the marketing presented by the lab is truthful and accurate.

Medical Necessity

It is the duty of the clinical laboratory to ensure that physicians are not ordering needless tests to be done. According to the guidelines, the laboratory will need to collect all necessary information from the ordering physician to conclude that the tests being called for are truly needed and correct. Clinical laboratories will also want to put systems into place to avoid confusion or miscommunication between the doctors and the laboratory to ensure the tests that are being done are what is actually ordered.

Fraud Alerts

Clinical laboratories must also pay attention to fraud alerts that are issued by the government. A lawyer can help the laboratory comply with these fraud alerts and ensure everything is performed correctly.


When billing and payment is handled by a third party like Medicare or Medicaid, there are certain rules that must be followed and steps that the laboratory will need to take. Working with a lawyer ensures that the process is followed smoothly, that billing is handed and under control, and that everything is properly and accurately paid for.

Price Setting

Some clinical laboratories may try to make deals with physicians in exchange for securing all that office’s business. When the clinical laboratory is charging far below the market value of their services, this can break the guidelines and cause problems for the lab. A lawyer can help the clinical laboratory set prices that are within the means of the guidelines laid out for them while still allowing them to receive the business that they need.

Standing Orders

Standing orders are permitted by the OIG, but there are rules that must be followed surrounding them. For example, standing orders need to be monitored and will have a set expiration date. Once that expiration date passes, to continue as a standing order, it will need to be renewed.

A lawyer can benefit a clinical laboratory both in preventative and defensive measures. Having a lawyer walk the clinical laboratory through the guidelines can help to prevent problems from arising in the future, but on the chance that they still appear, a lawyer can help to defend the laboratory and keep them from trouble.


Another major area what were a clinical laboratory may need a lawyer is in audit cases. If a clinical laboratory is being audited, investigated, or appealed, having an expert lawyer to work with can make the process run smoothly and help the outcome to end in the laboratory’s favor.

Working with the Right Lawyer

The right lawyer will do whatever needs to be done to ensure that the clinical laboratory comes out on top and that those working there do not lose their job because of a careless or someone’s unintentional mistake. With a commitment to bringing the best research possible to a defense and an understanding of the things that could possibly go wrong in a clinical laboratory, an expert lawyer can help ensure that the case is won.

There are a number of rules, regulations, and guidelines that a clinical laboratory will need to meet to stay in good standing. Whether your lab has already run into trouble meeting these expectations or you’re just looking to prevent an issue in the future, having a strong and experienced lawyer can help you exponentially. Contact a expert attorney as soon as you become aware of a problem against your clinical laboratory or if you just feel like a refresher course in the guidelines is necessary.



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