Preparing to Sell Your Laboratory

prepare a lab for sale

prepare a lab for saleBy: Dean Viskovich

COVID is front and center in all aspects of everyday life and has shined light in the strangest of places that were usually in the dark. In healthcare the laboratory space has always taken a backseat to other sectors in terms of recognition and value. The current climate in the lab space has shifted and it is not an illusion, labs are front and center.

COVID has taken its toll on areas of the economy and investors are certainly one of the first to become aware of this situation. Clinical laboratories are currently an attractive acquisition target and the reasons are numerous, sectors like retail, entertainment and travel are performing poorly and investors are shifting their investment dollars into healthcare and technology.  Investors are looking for growth and profitability and are finding it in healthcare.  Mergers and Acquisitions (M&A) is nothing new in the lab industry, but now careful consideration is required when it comes to deciding the appropriate time to sell your lab.

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A Self-Audit Checklist for Laboratories

By: Dean Viskovich

The Office of Inspector General (OIG) and other Federal agencies charged with responsibility for enforcement of Federal law have emphasized the importance of voluntarily developed and implemented compliance plans.  The government, especially the OIG, has a zero- tolerance policy towards fraud and abuse and uses its extensive statutory authority to reduce fraud in Medicare and other federally funded health care programs.  The OIG believes that through a partnership with the private sector, significant reductions in fraud and abuse can be accomplished.  Compliance plans offer a vehicle to achieve that goal.  The OIG has provided a model compliance plan for clinical laboratories to assist laboratory providers in crafting and refining their own compliance plans.

The OIG suggests that the comprehensive compliance program should include the following elements:

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The Most Important Role in the Clinical Lab Space: Lab Director

By: Dean Viskovich

Congress passed the Clinical Laboratory Improvement Amendments (CLIA) in 1988.  CLIA established quality standards for all laboratory testing to ensure the accuracy, reliability, and timeliness of patient test results regardless of where the test was performed.  In 2003, the Centers for Disease Control and Prevention (CDC) and the Centers for Medicare and Medicaid Services (CMS) published the CLIA Quality Systems laboratory regulations.  The quality system approach includes a laboratory’s policies, processes, procedures, and resources needed to obtain consistent, high quality testing services.

The laboratory must be under the direction of a qualified person and that person must fulfill all responsibilities of the lab director as outlined by CLIA.  CLIA prohibits a laboratory director from directing more than five non-waived laboratories.  Some states may have additional restrictions regarding the number of labs the lab director can direct. The lab director must meet education and experience requirements to hold the position and meet all requirements of the position.  The responsibilities include ensuring that there are sufficient personnel with adequate experience and training and make sure that every position in the lab is staffed by a person who is qualified to have the position and can perform all tasks required of the position.Continue reading

Standing Orders in Drug Treatment Programs: How to Avoid Waving a Red Flag

so 2014By: Karina P. Gonzalez

Medical necessity is the driving force for the payment of any service, but is especially worth noting when discussing laboratory testing. Standing Orders for urine drug testing in residential treatment settings are not prohibited, per se, but this practice must be built upon detailed policies and procedures that are precisely followed and are directed to individual patient needs.

The following conditions may help to determine whether Standing Orders are appropriate in a residential treatment setting:Continue reading

Blue Cross Lawsuit Against Avee Attacks Point of Care Testing

malpractice defense

bcbs lawsuitA recent lawsuit by Horizon Blue Cross/Blue Shield of New Jersey has the potential to cripple point of care testing arrangements often employed by drug and alcohol treatment centers.  At risk is not only the roughly $36 Million sought to be recouped by BC/BS, but also perhaps the many millions more which may be claimed by other payers as well.

BC/BS is making serious allegations against Avee Laboratories, Alere, Inc., and a number of recovery centers.  The factual allegations include:Continue reading

Drug & Alcohol Treatment Facilities Need to Focus on Licensure

Many drug and alcohol treatment facilities see continuity of care and income opportunities in providing qualitative (and even quantitative) toxicology screening to make sure they know (1) what their residents/patients are taking, and (2) in what quantities.  Facilities need to make sure they know that federal and state law will view them as a clinical lab, even when they are simply taking urine and using cups.  CLIA will require they obtain “waived” status (since dipsticks are in that category).  Facilities also need to examine whether state licensure (as a “Healthcare Clinic”) is also required.  Chapter 400, Florida Statutes requires any entity to obtain a healthcare clinic license if (a) healthcare services are provided, and (b) claims for those services are submitted.  Even though most facilities are out of network, most do submit claims to insurance carriers and hence implicate the state healthcare clinic license law (which is different from the CLIA law).

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