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Preparing to Sell Your Laboratory

by admin on March 10, 2021 No comments

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 admin on February 9, 2021 No comments

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 admin on February 8, 2021 No comments

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.

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Webinar | COVID-19 Impact on Laboratory Compliance

by admin on November 4, 2020 No comments

With a global pandemic, you can imagine the overwhelm and increase workload of laboratories. From the start, and even until today, COVID-19 testing has kept laboratory business operations busy. Join “The Lab Guy,” attorney Dean Viskovich for this informative webinar on how COVID-19 has impacted laboratories over the last eight months and what you can do to stay compliant.

Webinar register here button

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Lab Owner Indictment Update

by admin on October 7, 2020 No comments

fhlf laboratory complianceBy: Dean Viskovich

On October 6, 2020, the Unites States Attorney’s Office of the Western District of Louisiana announced that George M “Trey” Fluitt III of Monroe, Louisiana was indicted.  The federal grand jury indicted the lab owner for paying bribes and kickbacks in violation of the Anti-Kickback Statute, resulting in improper Medicare billing of approximately $117 million. Fluitt was the owner and operator of Specialty Drug Testing, LLC and is alleged to have solicited paid kickbacks and bribes in return for patient DNA specimens and physicians’ orders for cancer genetic and pharmacogenetic testing. Medicare allegedly paid Specialty Drug Testing, LLC $28,726,299 as a result of the fraudulent claims. If convicted, the defendant faces up to five years in prison for each count of conspiracy to defraud a healthcare program.  Fluitt also faces 10 years in prison for illegal kickbacks, a $250,00 fine, forfeiture and restitution.

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COVID-19 and Copays: What Responsibility Do Patients Have

by admin on October 6, 2020 No comments

fhlf covid and patient responsibility for copaysBy: Dean Viskovich

COVID-19 has affected all aspects of everyday life and healthcare rules and regulations are no exception.  All areas of healthcare have been impacted, including the patient’s financial responsibility for healthcare services in the form of co-insurance, copays and deductibles. The waiver of a patient’s financial responsibility for healthcare services is regulated by federal and state law. The waiver of co-pays, co-insurance and deductibles has been deemed a violation of the federal Anti-Kickback statue.  A provider who routinely waives the patient’s financial obligation may be violating the participating provider agreement with commercial carriers, state law and federal law with respect to Medicare beneficiaries.  Waiving patient fees is seen as an inducement to the patient to prefer one provider over another for financial reasons. However, The Centers for Medicare and Medicaid Services (CMS) and commercial carriers have been authorized by the federal government to waive patient financial responsibility during the pandemic in order to encourage the public to get treated for COVID-19 and non-COVID medical conditions without fear of a hefty bill.

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Florida Healthcare Law Firm Continues Team Expansion with Addition of Dean Viskovich, Laboratory Compliance & Operations Specialist

by admin on October 6, 2020 No comments

fhlf dean viskovich the lab guyFlorida Healthcare Law Firm in Delray Beach, FL has exceeded their 2020 growth plans with the fourth hire this year, seasoned attorney Dean Viskovich, aka “The Lab Guy”. Dean will play an essential role representing healthcare businesses and providers with respect to regulatory compliance matters and is uniquely experienced on issues pertaining to laboratory compliance, as well as laboratory operations. Dean has over 25 years’ experience in the health law space and is licensed in both Florida and New York.

Florida Healthcare Law Firm has announced that they have added Dean Viskovich, “The Lab Guy,” to the team. Dean brings a wealth of healthcare business expertise working on the inside in settings such as laboratories and health insurance companies. Dean has served as a trial attorney on behalf of insurance companies and healthcare providers. He specializes in laboratory compliance and offers education and training programs geared at OIG compliance. Dean’s extensive experience in laboratory compliance and operations includes Stark, Anti-Kickback, Fraudulent Claims Act, Safe Harbor and State regulatory provisions. Additional areas of expertise include billing, reimbursement, charge-master review, CPT, ICD-10, HCPC coding and audits.

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adminFlorida Healthcare Law Firm Continues Team Expansion with Addition of Dean Viskovich, Laboratory Compliance & Operations Specialist

Cold and Flu Season During a Pandemic

by admin on September 30, 2020 No comments

fhlf cold and flu during a pandemicBy: Dean Viskovich

What options do doctors have in determining if a patient has the flu or COVID-19?

The days of assuming a sniffle and low fever during the Fall are just signs of the common flu are long gone. The challenge doctors now face is determining whether a cough, temperature and sore throat is the flu or COVID-19. If the symptoms are essentially the same for both illnesses, what’s a doctor to do?  In the old days before Fall of 2019, a doctor would order a lab test to see if the patient tested positive for the flu. Today, a doctor who is faced (in person or virtually) with a patient with fever, chills, cough, runny nose, headaches and fatigue now must know if it is the seasonal flu or COVID-19. Ordering a COVID-19 test may seem like the obvious choice, but a more efficient alternative exists. Instead of a standalone COVID-19 test, ordering a comprehensive respiratory pathogen panel is a better decision.

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