Mandatory COVID-19 Vaccine and Incentives

Can an employer mandate a COVID-19 vaccination?  And if so, are there exceptions/exclusions that must be addressed?  Since the COVID-19 vaccines were first approved for emergency use, the debate has raged as to whether employers can or should require employees (as a condition of employment) to be vaccinated.  And, with large numbers on both sides of the debate, the answer, while clear from a legal standpoint (at least for the moment at the federal level) is not without controversy or consequences.

Requirements for Mandatory Vaccine Policies

Health care employers have long required flu vaccines of their employees, absent a medical reason or religious belief.  Accommodations have been made as required for those who cannot receive the vaccine.  And mandatory vaccines in the health care industry provide some protection for the health and safety of patients and the care providers. The same rationale and rules apply to the COVID-19 vaccine. Continue reading

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

COVID Vaccine Administration and Billing

By: Dean Viskovich

On November 13, 2020 Centers for Medicare and Medicaid Services (CMS) announced that all Americans will have access to the COVID-19 vaccine at no cost.  CMS has clearly communicated to private insurers, Medicaid programs and Medicare that it is their responsibility to cover the vaccine at no charge to beneficiaries.  CMS states that Operation Warp Speed ensures that States, provider’s and health plans have the information and direction they need to ensure broad vaccine access and coverages for all.  As a condition of receiving free COVID-19 vaccines from the federal government, providers will be prohibited from charging consumers for administration of the vaccine.

Beneficiaries with Medicare will not pay anything for the COVID-19 vaccine and their coinsurance/copayment and deductible amounts will be waived.  In 2021, for Medicare Advantage beneficiaries, Medicare will pay directly for the vaccine and its administration for those enrolled in MA plans.  MA plans are not responsible for reimbursing providers to administer the vaccine.  MA beneficiaries do not pay for the vaccine and copayment/coinsurance and deductibles are waived.Continue reading