Testing for COVID-19 certainly has evolved over the past 18 months or so. As supply and allocation continue to face challenges, guidance on serological/antibody versus viral testing, testing in the workplace, informed consent, among other things have emerged to help guide coronavirus testing in the workplace. President Biden’s Path out of the Pandemic (the “Path”) seeks to drive higher levels of COVID-19 vaccination, while allowing COVID-19 testing as an option under certain components of the Path. Testing as an option to vaccination is likely to create more demand for a product already in high demand, and organizations may need to think more carefully about how the President’s Path may change their current COVID programs. More at home testing may be what is needed to help get further down the Path.

A significant part of the Path for employers is the anticipated rule from the Department of Labor for employers with 100 or more employees. The Path explains:

The Department of Labor’s Occupational Safety and Health Administration (OSHA) is developing a rule that will require all employers with 100 or more employees to ensure their workforce is fully vaccinated or require any workers who remain unvaccinated to produce a negative test result on at least a weekly basis before coming to work. OSHA will issue an Emergency Temporary Standard (ETS) to implement this requirement. This requirement will impact over 80 million workers in private sector businesses with 100+ employees.

Employers’ struggle to get more of their workers vaccinated for COVID-19 continues. There are several reasons, more than can be identified and explained here. But some include the vaccine’s only having FDA Emergency Use Authorization (EUA) versus full FDA approval (although that is wearing away), required reasonable accommodations for disability and sincerely held religious beliefs, fears about complications from the vaccine, etc.

This has not stopped employers from rolling out a bevy of creative measures to drive vaccination levels higher – gift cards, paid time off, raffles, health plan premium surcharges, increase in paid holidays, and other perks for those who get the vaccination. Some of these efforts have helped. Delta Airlines recent announcement of a $200 health plan premium surcharge is reported to have moved 4,000 of its 20,000 unvaccinated employees to get the vaccination. Still, according to health experts, levels of vaccination are not where they should be and the Delta variant continues to spread.

It is likely, at least in the short run, that a significant segment of the population will remain unvaccinated, notwithstanding the President’s Path, DOL guidance, and employer incentives. So, as weekly testing is likely to become more common, employers will need to manage that cadence at a reasonable cost and with minimal administration, and at home testing may be the answer for a lot of organizations. As reported by the Washington Post:

Most take-home tests, including BinaxNOW and Quidel’s QuickVue test, are antigen tests that look for protein pieces of the virus. PCR tests detect the virus’s genetic material.

Home tests are less sensitive than PCR tests and tend to be better at turning up positive results in people who are symptomatic than those without obvious signs of illness. But they offer some key advantages. Results usually show up in 10 to 15 minutes. And they can be administered at the point of care — nursing homes, clinics, schools, private residences. Most PCR tests are administered at testing sites and need to be sent to labs, meaning turnaround time is almost always 48 hours or more.

There are still lots of issues that need to be considered, not the least of which are the anticipated guidance from the DOL/OSHA and cost. On the issue of cost, one question has been whether at home or other point-of-care tests have to be covered under a group health plan. CMS guidance from earlier this year provides some insight:

Q4. Do point-of-care tests for COVID-19 have to be covered without cost sharing under the FFCRA?

Yes. The FFCRA and the CARES Act make no distinction between point-of-care and other tests; all COVID-19 diagnostic tests that meet one of the criteria outlined in section 6001 of the FFCRA, as amended by section 3201 of the CARES Act, must be covered without cost sharing, prior authorization, or medical management (including for asymptomatic individuals with no known or suspected exposure to COVID-19). 

However, the same guidance clarifies “plans and issuers are not required to provide coverage of testing such as for public health surveillance or employment purposes. But there is also no prohibition or limitation on plans and issuers providing coverage for such tests.

Nonetheless, as employers begin to ramp up to get on the President’s Path, at-home antigen testing for employees may be a significant part of their plans.    

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Photo of Joseph J. Lazzarotti Joseph J. Lazzarotti

Joseph J. Lazzarotti is a Principal in the Morristown, New Jersey, office of Jackson Lewis P.C. He founded and currently leads the firm’s Privacy, e-Communication and Data Security Practice, edits the firm’s Privacy Blog, and is a Certified Information Privacy Professional (CIPP) with…

Joseph J. Lazzarotti is a Principal in the Morristown, New Jersey, office of Jackson Lewis P.C. He founded and currently leads the firm’s Privacy, e-Communication and Data Security Practice, edits the firm’s Privacy Blog, and is a Certified Information Privacy Professional (CIPP) with the International Association of Privacy Professionals. Trained as an employee benefits lawyer, focused on compliance, Mr. Lazzarotti also is a member of the firm’s Employee Benefits Practice Group.

In short, his practice focuses on the matrix of laws governing the privacy, security, and management of data, as well as the impact and regulation of social media. He also counsels companies on compliance, fiduciary, taxation, and administrative matters with respect to employee benefit plans.

Privacy and cybersecurity experience – Mr. Lazzarotti counsels multinational, national and regional companies in all industries on the broad array of laws, regulations, best practices, and preventive safeguards. The following are examples of areas of focus in his practice:

  • Advising health care providers, business associates, and group health plan sponsors concerning HIPAA/HITECH compliance, including risk assessments, policies and procedures, incident response plan development, vendor assessment and management programs, and training.
  • Coached hundreds of companies through the investigation, remediation, notification, and overall response to data breaches of all kinds – PHI, PII, payment card, etc.
  • Helping organizations address questions about the application, implementation, and overall compliance with European Union’s General Data Protection Regulation (GDPR) and, in particular, its implications in the U.S., together with preparing for the California Consumer Privacy Act.
  • Working with organizations to develop and implement video, audio, and data-driven monitoring and surveillance programs. For instance, in the transportation and related industries, Joe has worked with numerous clients on fleet management programs involving the use of telematics, dash-cams, event data recorders (EDR), and related technologies. He also has advised many clients in the use of biometrics including with regard to consent, data security, and retention issues under BIPA and other laws.
  • Assisting clients with growing state data security mandates to safeguard personal information, including steering clients through detailed risk assessments and converting those assessments into practical “best practice” risk management solutions, including written information security programs (WISPs). Related work includes compliance advice concerning FTC Act, Regulation S-P, GLBA, and New York Reg. 500.
  • Advising clients about best practices for electronic communications, including in social media, as well as when communicating under a “bring your own device” (BYOD) or “company owned personally enabled device” (COPE) environment.
  • Conducting various levels of privacy and data security training for executives and employees
  • Supports organizations through mergers, acquisitions, and reorganizations with regard to the handling of employee and customer data, and the safeguarding of that data during the transaction.
  • Representing organizations in matters involving inquiries into privacy and data security compliance before federal and state agencies including the HHS Office of Civil Rights, Federal Trade Commission, and various state Attorneys General.

Benefits counseling experience – Mr. Lazzarotti’s work in the benefits counseling area covers many areas of employee benefits law. Below are some examples of that work:

  • As part of the Firm’s Health Care Reform Team, he advises employers and plan sponsors regarding the establishment, administration and operation of fully insured and self-funded health and welfare plans to comply with ERISA, IRC, ACA/PPACA, HIPAA, COBRA, ADA, GINA, and other related laws.
  • Guiding clients through the selection of plan service providers, along with negotiating service agreements with vendors to address plan compliance and operations, while leveraging data security experience to ensure plan data is safeguarded.
  • Counsels plan sponsors on day-to-day compliance and administrative issues affecting plans.
  • Assists in the design and drafting of benefit plan documents, including severance and fringe benefit plans.
  • Advises plan sponsors concerning employee benefit plan operation, administration and correcting errors in operation.

Mr. Lazzarotti speaks and writes regularly on current employee benefits and data privacy and cybersecurity topics and his work has been published in leading business and legal journals and media outlets, such as The Washington Post, Inside Counsel, Bloomberg, The National Law Journal, Financial Times, Business Insurance, HR Magazine and NPR, as well as the ABA Journal, The American Lawyer, Law360, Bender’s Labor and Employment Bulletin, the Australian Privacy Law Bulletin and the Privacy, and Data Security Law Journal.

Mr. Lazzarotti served as a judicial law clerk for the Honorable Laura Denvir Stith on the Missouri Court of Appeals.