Steve Altschuler

Medical information requests (MIRs) are a crucial part of the healthcare and life sciences industry, allowing healthcare providers to obtain the information they need to provide the best possible care for their patients. However, without an efficient MIR management process, delays and inaccuracies can jeopardize patient safety, regulatory compliance, and a company's reputation.

In this guide, we'll explain what MIRs are, why they matter, and share best practices for handling them. We'll also cover the benefits of using a centralized management strategy and process automation tools, such as BP Logix's MIR solution, which can alleviate common MIR management challenges and ensure prompt, accurate, and compliant handling.

Whether you're a medical affairs professional, healthcare provider, or pharma executive, this guide will help you navigate the complex world of medical information requests. Already well-versed in MIRs? Skip ahead to MIR management best practices!

Types of medical information requests

MIRs can take many forms:

• Adverse event reporting

• Product information requests

• Medical inquiries

• Clinical study data

• Off-label information

• Product complaints

Let's delve into what these MIR types entail and what role they play in the lives of healthcare providers, patients, and medical affairs teams.

Adverse event reporting

Adverse event reporting is a critical component of medical information requests. In this type of request, healthcare providers submit information about any undesirable or unexpected health events experienced by patients while using a particular medication or medical device. These events could range from mild side effects to severe allergic reactions or even fatalities.

For instance, imagine a patient is prescribed a new medication and then experiences an adverse health event that they suspect is caused by the medication. The healthcare provider would then create an adverse event report to submit to the company that manufactures the medication. This report would contain detailed information about the patient, the medication, and the adverse event experienced.

Pharmaceutical companies must carefully track and promptly respond to all adverse event reports they receive. Failure to do so can have severe consequences, including patient harm, regulatory sanctions, and reputational damage. Effective management of adverse event reporting is essential for maintaining patient safety and ensuring that products remain compliant with regulatory requirements.

Product information requests

Product Information Requests (PIRs) are a common type of MIR that medical affairs teams handle. PIRs seek general information about a product such as its indications, dosages, contraindications, and clinical trial results.

For example, a physician might request PIRs to understand whether a medication would be a suitable option for their patient with a specific condition. Another provider may want more information on a medication than what is listed on the label.

Handling PIRs requires the ability to provide comprehensive information about the product to healthcare providers while ensuring regulatory compliance. It is essential to handle these requests efficiently as they could impact providers’ decision-making process and, ultimately, patient outcomes.

Medical inquiries

Medical inquiries are a specific type of medical information request that requires a detailed response from a medical affairs team. These requests are often initiated by healthcare providers seeking guidance on a specific medical issue or question related to a product.

Let's say a provider inquires about the appropriate dosage for a patient with a specific medical condition, or the potential drug interactions of a product with other medications. As with other types of MIRs, it is important for companies to respond to medical inquiries in a timely and accurate manner to provide healthcare providers with the necessary information to make informed decisions.

Clinical study data

Clinical study data requests are another common type of MIR. Healthcare providers may request access to detailed clinical study data, such as results from clinical trials, to help them make informed decisions about treatment options for their patients.

For instance, a physician may request clinical study data on a new medication before prescribing it to their patient. This request may include information about the drug’s safety, efficacy, and potential side effects.

Handling clinical study data requests requires companies to provide accurate and comprehensive data while adhering to regulatory requirements for data privacy and protection.

Off-label information

Off-label information requests are a specific type of MIR that requires companies to respond to requests for information about the use of a product outside of its approved label indications. These requests could include information about the potential benefits and risks of using a product off-label.

Let's say a healthcare provider inquires about using a medication to treat a condition not listed on its label indications. In these cases, companies must ensure that their responses are accurate and do not promote the off-label use of their product.

Handling off-label information requests requires companies to carefully evaluate the information they provide and ensure that their responses comply with regulatory requirements.

Product complaints

Product complaints are a type of MIR that companies use to collect and address customers' concerns about their products. These complaints can range from product quality to issues with packaging, labeling, or other components of the product.

Imagine a patient files a complaint about a medication they took because they believe it's causing them harm. A company must investigate the complaint thoroughly and respond in a timely manner to address any issues with their product.

Handling product complaints requires companies to have an effective complaint management process in place to investigate and address concerns raised by patients.

Why medical information requests matter

MIRs have a significant impact on providers and patients, as well as medical affairs professionals and the organizations they represent. As such, it is essential for life science companies to establish clear MIR submission protocols and develop an efficient system for processing incoming requests.

While larger companies often have a dedicated team to handle MIRs, smaller organizations may have limited resources and rely on a smaller team to manage these requests. Regardless of the size of the organization, it is crucial to handle MIRs efficiently and respond to them promptly in order to:

• Ensure regulatory compliance

• Keep patients safe

• Manage company reputation

• Maintain competitive advantage

• Continuously improve

Let's take a closer look at why mastering medical information request management is vital in these areas:

Regulatory compliance

Pharmaceutical and medical device companies have a legal obligation to provide timely, accurate information about their products to the general public, patients, and healthcare professionals. Failure to comply can result in severe consequences, including legal actions, fines, and damage to your company's reputation.

The Food and Drug Administration (FDA) mandates this reporting and outlines pharmaceutical companies' responsibilities in its authoritative guide, “Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices.”

Under these guidelines, pharmaceutical companies must respond truthfully to unsolicited medical information requests. Misleading information and off-label promotion of product uses are prohibited in these responses, and the company must maintain detailed records of all MIRs and their responses.

Regulatory requirements for MIRs are becoming increasingly stringent. Non-compliant organizations risk penalties and other punitive measures. By ensuring regulatory compliance, you protect your business continuity and profitability.

Patient safety

Prompt and accurate responses to medical information requests are crucial to ensuring patient safety. When healthcare providers have access to the information they need about medications and devices, they can make informed decisions that promote positive health outcomes.

However, when pharmaceutical companies are slow to respond to MIRs, patient safety can be compromised. Providers may be hesitant to prescribe a particular medication, potentially resulting in delayed or inadequate treatment for patients.

MIRs also provide healthcare providers with a way to report concerns or adverse events, which pharmaceutical companies can use to improve products and protect patients from the risks associated with faulty devices or medications. By prioritizing the efficient management of MIRs, companies can maintain a strong focus on patient safety and improve overall healthcare outcomes.

Reputation management

In today's age of social media and online reviews, negative news can spread rapidly, potentially harming a pharmaceutical company's reputation. To stay ahead of any rumors or concerns, it's crucial to respond quickly and effectively to medical information requests.

Swift, accurate responses to MIRs can help put out any potential fires before they spread too far. This proactive approach can help maintain public trust and protect a company's reputation from the fallout of adverse events.

On the other hand, slow or inaccurate responses can have the opposite effect, damaging public trust and causing patients to seek out competitor products. Mishandling MIRs can ultimately lead to decreased product usage and revenue loss.

Competitive advantage

In the fiercely competitive industry of life sciences, companies must go the extra mile to maintain an edge over their rivals. Responding to medical information requests promptly is an excellent way for companies to gain a competitive advantage.

A streamlined MIR process shows healthcare providers that a company is transparent, trustworthy, and patient-focused. These factors are crucial in building long-term trust and relationships with providers and patients.

By developing an efficient MIR process, pharmaceutical companies can help providers make informed decisions about prescribing their products. This proactive approach can alleviate prescription hesitancy and increase the likelihood of a provider choosing their product over a competitor's.

Ultimately, having an efficient and effective MIR process can set a company apart from its rivals and contribute to its long-term success.

Continuous improvement

In order to provide better outcomes for patients, life science organizations must be able to stay ahead of the curve. This is another area in which MIRs shine — they can provide valuable insights that may help companies innovate and drive continuous improvement in their products.

For example, imagine there is a medication indicated for pain relief that could also help patients overcome sleep issues. By bringing this information to organizational decision-makers, the company could obtain funding to explore other uses for the medication — ultimately helping them stay competitive in the market, generate more revenue, and improve patient outcomes.

Best practices for handling medical information requests

Managing medical information requests can be challenging, but life science companies can simplify the process and promote transparency by following a few established best practices.

Specifically, organizations tasked with handling medical information requests should:

1. Develop a clear, standardized process

The first step to mastering medical information request management is developing a clear and standardized process.

A well-designed process will act as a blueprint for the medical information team to follow and should cover the intake, response, tracking, and record-keeping aspects of MIR. It should also align with FDA guidelines to guarantee compliance and prevent any monetary repercussions.

Without a clear process to follow, the medical information team may miss key steps in the process, leading to delays in responding to requests, inaccurate information, and even noncompliance with FDA regulations. Inconsistent processes can also lead to confusion among team members, making it difficult to track and manage requests efficiently. A standardized process is essential for ensuring that all medical information requests are handled promptly, accurately, and in compliance with regulations.

To create a robust and comprehensive process, it's essential for decision-makers to gather feedback and input from the people who are most familiar with the day-to-day management of medical information requests. This feedback can help ensure that the process is clear, comprehensive, and easy to follow for all team members. The end result is a well-designed process that meets the needs of the organization while also ensuring compliance and efficiency in managing MIRs.

2. Create a dedicated medical information team

All organizations, regardless of size, should establish a dedicated medical information team to manage MIRs. This will ensure that requests are promptly and efficiently processed, and nothing falls through the cracks. If responsibilities are delegated to other teams, such as sales or marketing, it can lead to delayed responses, compliance issues, and damage to a company's reputation.

Creating a dedicated MIR team will require effort, but the benefits will be worthwhile. This team will be better equipped to handle requests, maintain compliance, and ensure that information is communicated transparently.

While some smaller companies may not have the resources to create a dedicated medical information team, there are ways to overcome this challenge and still manage MIRs effectively.

One option is to assign MIR responsibilities to a small group of individuals within the organization who have transferrable expertise and knowledge to handle these responsibilities.

Another option is to harness process automation to help streamline MIR management and reduce the need for a large team. Automated systems can be used to track and manage requests, respond to routine inquiries, and flag urgent requests for immediate attention. This can help smaller organizations manage MIRs more efficiently while maintaining compliance and ensuring prompt responses to healthcare professionals.

3. Use a centralized system to manage MIRs

Managing medical information requests through email or shared files can be risky and cause unnecessary confusion. Without a centralized system to manage MIRs, time-sensitive requests can get lost or overlooked, leading to delayed responses and a risk of noncompliance. This can cause friction among healthcare providers and ultimately damage the organization's reputation.

Additionally, managing MIRs without a standardized process can create confusion among team members about their roles and responsibilities, leading to inconsistent responses and inaccurate information being disseminated to healthcare providers.

Implementing a centralized system to manage MIRs will simplify the process, prevent any mishaps, and ensure that all requests are responded to promptly. Storing MIR data in a single location will help the MIR team leader oversee the management of requests and verify that the team responds to them appropriately based on their priority and urgency.

4. Implement a prioritization system

Pharmaceutical companies should prioritize MIRs to ensure that urgent requests are handled before routine inquiries. Developing a prioritization system will help the medical information team manage their workload and address requests based on their urgency.

For instance, consider a medical information team that receives two MIRs on the same day: one is a routine inquiry about dosage information, while the other reports a potential adverse event associated with one of the company's products. In this scenario, the team should prioritize the adverse event MIR, addressing it promptly to mitigate potential risks to patient safety. MIRs that are of equal urgency should be handled based on the order they are received.

Having a clear prioritization system in place ensures that the team is efficiently managing their workload while addressing the most pressing issues first.

5. Monitor MIR response performance

Want to ensure that your medical information request management program is continuously improving? Consider monitoring the the performance of your organization's MIR responses. You can gain valuable insights to make data-driven decisions by tracking metrics like response times, request volumes, and other relevant data points.

For example, let's say a pharmaceutical company notices an increasing trend of requests regarding potential off-label uses of their product. By monitoring this trend and analyzing the data, the company can conduct further research into the potential off-label uses, test the product's efficacy in those areas, and potentially apply for FDA approval for new indications.

This type of data-driven decision-making leads to product innovation, new opportunities in the market, and increased revenue.

On the other hand, neglecting to monitor MIR response performance could lead to missed opportunities for growth and potential noncompliance with regulatory requirements. For example, let's say a pharmaceutical company receives an MIR regarding the use of their product in a specific patient population. Monitoring MIRs may help the company identify potential gaps in how they are labeling or indicating their product. Failing to address these gaps puts the company at risk for being noncompliant with FDA regulations, resulting in fines, penalties, and PR nightmares.

By monitoring MIR response performance, companies can avoid regulatory issues and protect their reputation from negative PR. The insights gained from monitoring response performance can also help companies continuously improve their MIR process as a whole by allocating resources more effectively and going the extra mile to meet the needs of healthcare providers and their patients.

Automating your centralized MIR system

Implementing the best practices and centralizing your MIR system is essential for compliance and efficient management of medical information requests. However, not all centralized systems are equal, and rudimentary ones such as shared email inboxes lack the tools and management capabilities necessary to ensure compliance.

To meet FDA requirements for adverse event handling and auditing, it's crucial to route inquiries to the appropriate team members. Failing to do so can result in difficulty obtaining treatment approvals and even revocation of previously approved treatments, as demonstrated by the cases of chloroquine phosphate and hydroxychloroquine sulfate.

To ensure compliance and efficient MIR management, consider implementing a powerful management system that includes sophisticated process automation tools. Leveraging tools such as BP Logix’s MIR solution enables you to tap into the power of predictive analytics, facilitate centralized data management, automate workflows, and integrate your database with existing systems.

Process automation tools not only streamline your MIR system but also reduce manual errors, speed up response times, and enable proactive management of requests, leading to a more efficient and compliant system.

Optimize MIR management with BP Logix

Medical information requests are a critical aspect of the healthcare industry, with the potential to influence patient outcomes, regulatory compliance, and revenue generation. As such, it's imperative to have a robust and streamlined process in place to manage them effectively.

By embracing process automation and optimization tools, you can revolutionize your approach to MIRs and achieve a more efficient and compliant management system. With BP Logix's MIR solution, you can leverage cutting-edge predictive analytics, centralized data management, and customizable workflow automation to streamline your MIR process and reduce the risk of errors and compliance issues.

Our advanced platform also enables seamless integration with existing systems and workflows, making it easy to adopt and implement into your existing infrastructure.

With BP Logix's MIR solution, you can ensure that your organization is equipped to manage MIRs effectively, promote compliance, and protect your reputation in the healthcare industry. Contact us today to learn more and take the first step towards optimizing your MIR management process.

OSHA may not be enforcing their ETS at a federal level, but that isn't stopping some state and local governments from moving forward with their own guidelines requiring employers to track employee vaccinations and enforce testing.

In California, employers must comply with the Cal/OSHA COVID-19 Prevention ETS, which was updated in December 2021 with changes that include the adoption of California Department of Public Health (CDPH) guidance on isolation and quarantine recommendations.

These revisions, which went into effect on Jan. 14, include things like updated standards for acceptable face coverings and new definitions for the term "fully vaccinated." However, the changes that are likely to have the biggest operational impacts on employers revolve around return-to-work requirements and testing protocols.

In this article, we'll summarize these changes and explain how California employers can reduce the administrative burden of complying with them.

Return-to-work requirements

One of the most impactful revisions to the Cal/OSHA ETS concerns the timelines and requirements for allowing employees to return to work following a positive test or close contact. The return-to-work criteria in the revised ETS are as follows:

Employees who test positive for COVID

Any employee, regardless of their vaccination status, must isolate for a minimum of 5 days if they test positive for COVID.

An employee may return to the workplace after day 5 if symptoms are not present or are resolving and a diagnostic test collected on day 5 comes back negative. If they return to the workplace after day 5, they must wear face covering around other for 10 days following the positive test.

If the employee does not undergo testing or if their symptoms do not resolve, they may return to work once their symptom resolve or until after day 10. The one exception is a fever – an employee may not return to work until their fever resolves.

Employees who are exposed to COVID

Unvaccinated

Employees who are not fully vaccinated are required to quarantine for a minimum of 5 days if they have been exposed to someone with COVID-19.

The exposed employee must take a COVID test on day 5, and if no symptoms are present and the specimen tests negative, the employee may return to the workplace. If the employee does not undergo testing and does not have symptoms, they may return to the workplace after day 10. If they test positive, they must follow isolation requirements.

Fully vaccinated

If an employee is fully vaccinated with a booster or they are fully vaccinated but not yet eligible for their booster, they are not required to quarantine after exposure to someone with COVID.

However, they must test negative on day 5 following exposure, as well as wear facial coverings around other for 10 days following exposure. If they develop symptoms, they must be excluded from the workplace pending test results, and if they receive positive test results, they must isolate.

Vaccinated but not boosted despite eligibility

If a vaccinated employee is booster-eligible but has not received their booster yet, they are required to quarantine and obtain a negative tests 3-5 days after being exposed to someone with COVID-19.

Regardless of test results, they must wear facial coverings around others for 10 days following the exposure.

Testing standards and availability

Additional revisions to the Cal/OSHA ETS seek to improve the standards and availability of COVID testing in the workplace. These changes include:

Improving the integrity of self-administered tests

The definition of "COVID-19 test" now includes specific instructions for workers using a test at home with self-read results.

According to Cal/OSHA ETS, "over-the-counter (OTC) tests may not be both self-administered and self-read unless observed by the employer or an authorized telehealth proctor."

Making testing widely available during outbreaks

In the event of an outbreak, employers must make weekly COVID-19 testing available to all employees, regardless of their vaccination status. For major outbreaks, employers must make testing available to all employees on a twice-weekly basis (or more frequently depending on local health department recommendations).

A vaccination and COVID test tracking solution for California employers

All of the requirements in the Cal/OSHA ETS are designed to make workplaces safer, but that leaves employers holding a bag brimming with logistical and administrative headaches.

From juggling all the complex variables of the return-to-work process to arranging for independent observation of employee testing, there's an awful lot of moving parts employers need to consider.

That's why employers in California are turning to BP Logix's Vaccine Tracker App to manage their workplace vaccination/testing policy. With this solution, employers can ensure compliance with the Cal/OSHA ETS, keep employees safe and fit for duty, and reduce potential impacts to revenue during an outbreak.

Ready to learn more about vaccine tracking for employers in California? Book a free demo today.

With all the recent legal challenges to federal vaccine requirements, there's a lot of confusion about the status of not only the OSHA ETS but also the CMS mandate.

While the OSHA ETS has likely exhausted its chances of passing, the Supreme Court has allowed the CMS mandate to move forward per a recent ruling on Jan. 13 that overturned stays of the CMS mandate that had been applied to 25 states.

There are still court cases pending, although given the ruling, it would appear that those legal battles will face a significant challenge in getting the CMS mandate overturned.

In this article, we explain everything you need to know about the CMS and walk through what healthcare organizations need to be doing right now to prepare.

The CMS mandate, explained.

The Centers for Medicare & Medicaid Services (CMS) vaccine mandate was first announced in September 2021 as component of President Biden's sweeping vaccination plan that also included the OSHA ETS and federal contractor mandate. Broadly, this mandate would require vaccination of any staff working in healthcare facilities that participate in Medicare/Medicaid.

Let's explore some common questions about the CMS mandate:

1. What healthcare facilities are covered under the CMS mandate?

The CMS mandate applies to healthcare facilities regulated by Medicare, including:

• Ambulatory surgery centers (ASC)
• Clinics
• Community mental health centers
• Comprehensive outpatient rehabilitation facilities (CORF)
• Critical access hospitals (CAH)
• End-stage renal disease (ESRD) facilities
• Home health agencies (HHA)
• Home infusion therapy suppliers
• Hospices
• Hospitals
• Intermediate care facilities for individuals with intellectual disabilities
• Long-term care facilities
• Medicare federally qualified health centers (FQHC)
• Programs for all-inclusive care for the elderly organizations (PACE)
• Psychiatric residential treatment facilities (PRTF)
• Public health agencies as providers of outpatient physical therapy and speech-language pathology services
• Rehabilitation agencies
• Rural health clinics (RHC)

The CMS rule does not apply to most physician groups, even if they participate in the Medicare or Medicaid program.

2. How is the CMS mandate different from the OSHA ETS vaccine-or-test guidelines?

Unlike the OSHA ETS, the CMS mandate is a full vaccination mandate. There is no option for testing, although there are still provisions for accommodations based upon disability, medical reasons or sincerely held religious beliefs. Also, the CMS mandate applies to all staff in covered healthcare facilities, not just employees. This includes licensed practitioners, students, trainees and volunteers. The mandate also applies to any individual who provides care, treatment or any other service for the facility or their patients.

3. What are the compliance deadlines for the CMS mandate?

There are two sets of deadlines for states, depending on whether the state was one of the 25 where the stay had been in place or not.

For providers in the District of Columbia, U.S. territories and the 25 states where the stay was not in place, the deadlines are as follows:

• By January 27, CMS will expect covered facilities to have developed and implemented policies and procedures to ensure that all staff are vaccinated and that 100% of staff have received at least one dose of the vaccination, or have a pending request for, or have been granted a qualifying exemption.
• By February 26, those facilities must also ensure that 100% of staff have completed their vaccine series or have been granted a qualifying exemption.

The 25 states subject to these deadlines are California, Colorado, Connecticut, Delaware, Florida, Hawaii, Illinois, Maine, Maryland, Massachusetts, Michigan, Minnesota, Nevada, New Jersey, New Mexico, New York, North Carolina, Oregon, Pennsylvania, Rhode Island, Tennessee, Vermont, Virginia, Washington, and Wisconsin.

For the 24 states in which the CMS had been stayed (until being lifted by the SCOTUS ruling), the deadlines are as follows:

• By February 14, covered facilities are expected to have developed and implemented policies and procedures to ensure that all staff are vaccinated and that 100% of staff have received at least one dose of the vaccination, or have a pending request for, or have been granted a qualifying exemption.
• By March 15, those facilities must also ensure that 100% of staff have completed their vaccine series or have been granted a qualifying exemption.

The 24 states subject to the deadlines above are Alabama, Alaska, Arizona, Arkansas, Georgia, Idaho, Indiana, Iowa, Kansas, Kentucky, Louisiana, Mississippi, Missouri, Montana, Nebraska, New Hampshire, North Dakota, Ohio, Oklahoma, South Carolina, South Dakota, Utah, West Virginia and Wyoming.

What about Texas?

Texas is a special case in which the compliance deadlines have not been determined yet.

4. What happens in the event of non-compliance?

CMS has stated that within 90 days of the issuance of applicable guidance (on December 28, 2021 or January 14, 2022, depending on whether the state had been stayed or not), facilities that fail to maintain compliance may be subject to enforcement action.

That enforcement remedy for non-compliance is termination of the provider’s ability to offer Medicare and Medicaid services, although for nursing homes, home health agencies, and hospices, CMS may impose civil monetary penalties or deny payments. For CMS, however, the primary goal is to bring facilities into compliance. Termination or penalties would only occur after a facility is provided with an opportunity to make corrections and come into compliance.

What should healthcare employers be doing about the CMS mandate?

There are 4 things that healthcare providers need to consider when evaluating their next steps.

1. Confirm whether they are a covered facility.

Simply receiving Medicare or Medicaid funds does not by itself mean that a facility is covered by this rule. The rule only applies to certified providers which involves an application and surveying process, adherence to conditions of participation and being subject to period follow-up surveys. There is a list below that identifies the types of facilities that would qualify as a covered facility.

2. Roll out a facility vaccination policy aligned with CMS requirements.

If they are a covered facility, they need to be tracking vaccination status and issue a policy by January 27 (or February 14). The facility should determine and continue to track the vaccination status of its staff. Covered facilities should have developed policies describing how applicable tracking has been implemented along with compliance, recordkeeping documentation and training requirements. Also, procedures should have been implemented to ensure confidential consideration and responses to requests for accommodation, which would include any additional precautions that would be applicable to individuals who are granted accommodations. The facility needs to be prepared for CMS inspections, which will likely begin in the next few weeks or months.

3. Understand how the CMS mandate intersects with other orders.

They need to be aware of state laws or executive orders which conflict with the CMS mandate. Those states are primarily Florida, Texas, Tennessee and Montana. Usually, a federal law would prevail but with the litigation environment, facilities should be prepared for further legal challenges.

4. Have a plan to handle employee requests for accommodations.

As providers who may have already mandated vaccines are aware, employees will make requests for accommodations based on medical or religious reasons. Prompt and appropriate processing of those requests is crucial to complying with both the CMS mandate as well as other federal laws. It is critical to directly engage with employees in this interactive process and documenting that process and those efforts are extremely important.

Prepare for the CMS mandate

Complying with the CMS mandate doesn't have to be a logistical nightmare. Comply with the federal CMS mandate and make it as easy as possible for staff to submit proof of COVID-19 vaccination status with the BP Logix Vaccine Tracker.

Book your free demo today.

COVID-19 and the workplace

The coronavirus (COVID-19) pandemic disrupted labor markets and different sectors across the world in 2020. Regulatory bodies have come up with a wide range of standards for employers and instructions for compliance officers to reduce the impact of the COVID-19 pandemic on the workforce. For instance, OSHA issued an emergency testing standard (ETS) mandate to protect employees from the risk of COVID-19.

In this article, we’ll review OSHA’s ETS vaccine mandate, its requirements for employers, effective dates, and ramifications of non-compliance.

First, what is OSHA?

Occupational Safety and Health Administration (OSHA) is a regulatory agency of the United States Department of Labor. It aims to improve workplace safety and facilitate healthy working conditions by enforcing standards and guidelines for employers. It also offers training, assistance, and education to employers on creating a secure workplace for working men and women.

The regulatory agency conducts inspections at workplaces and imposes fines for compliance violations. Inspections are often triggered by referrals, workplace fatalities, workplace injuries, and employee complaints. Inspections are conducted without any advance notice by trained compliance officers through telephonic discussions and/or on-site visits.

What is the OSHA ETS vaccine mandate, and what does it mean for my business?

OSHA issued an ETS that requires private employers operating with 100 or more employees to ensure all their workers get fully vaccinated. 

In lieu of the OSHA ETS COVID-19 vaccine mandate, employers should provide weekly COVID-19 negative test reports of employees and enforce wearing a face mask in the workplace (these rules may change from time to time based on the decisions of the Federal Government and the Department of Labor in conjunction with COVID-19 trends). 

A few vital aspects of OSHA’s ETS vaccine mandate for employers are:

Support for vaccination

As per the ETS, every employer should support the COVID-19 vaccination by:

1. Providing sufficient time for each employee to get vaccinated.
2. Offering a paid sick leave to recover from vaccination side effects.

Obtain and maintain records

As per the ETS mandate, employers must maintain a record of every employee’s vaccination status.

Employers need to provide proof of vaccination, which may include:

1. The medical report documenting the COVID-19 vaccination.
2. The COVID-19 vaccination record card itself.
3. The record of immunization from a healthcare provider or public health information system.

Weekly COVID-19 testing

Employers should conduct a weekly COVID-19 test for employees who are not fully vaccinated. If a remote employee is returning to the workplace, he or she should be tested for COVID-19 within 7 days before returning to work.

Communication

It is the responsibility of the employer to communicate ETS requirements, guidelines, policies, and standards to employees in a language they understand. 

The employer vaccine mandate is in place to protect workers from falling ill, spreading the virus, and in severe cases, passing away due to the virus. OSHA believes that the pandemic can be controlled if employers have a framework that emphasizes full vaccination, the use of face masks, frequent testing, and not allowing infected employees inside of the workplace.

Note: Even if a vaccine mandate from OSHA were to not exist, employers would still need to implement a vaccine tracking solution sooner rather than later because it’ll allow them to:

1. Reduce the administrative burden of managing variations in vaccine policies across the country.
2. Reduce the general liability of unsafe workplaces and avoid lawsuits from employees.
3. Monitor and maintain the general health of all employees to the best of their abilities.

Employers covered by the ETS

Private companies with 100 or more employees and state and local government employers with OSHA-approved State Plans are covered by the ETS. However, not all employees working for employers covered by the ETS are required to follow the provisions of the ETS.

The guidelines of the ETS do not apply to the following types of employees even though their employers are covered by the ETS:

1. Employees who are working from home.
2. Employees who work outdoors.
3. Employees who don’t attend workplaces where others are present.

Workplaces not covered by the ETS

OSHA believes that not all workplaces have the capability to implement programs that comply with the requirements in the ETS.

The following types of workplaces are not covered by the ETS:

1. The Safer Federal Workforce Task Force.
2. Healthcare settings that offer healthcare and support services.
3. Private companies with fewer than 100 employees.
4. Public employers in states without State Plans.

OSHA ETS vaccine mandate FAQs

What does the ETS require of employers?

Employers are responsible for:

• Implementing and enforcing workplace vaccination policy that either (a) requires mandatory vaccinations, or (b) allows employees to choose between vaccination or weekly COVID-19 testing.
• Providing information to employees about the ETS, COVID-19 vaccines, and workplace vaccination policy.
• Determining the vaccination status of all employees, obtaining valid proof of vaccination or weekly test results, and maintaining records to ensure compliance.
• Reporting work-related COVID-19 fatalities and hospitalizations to OSHA.

What employers are covered under the ETS? 

All employers currently under OSHA’s jurisdiction would be obligated to comply with the ETS if they have 100 or more employees. This accounts for approximately two-thirds of all U.S. workplaces in the private sector. 

What workers are counted under the 100-employee rule?

Generally, if a worker is directly employed by a company, they will be counted toward the 100-employee threshold that determines whether an employer is covered by the ETS. This includes:

• Remote employees
• Part-time employees
• Employees that work exclusively outdoors
• Temporary or seasonal workers

Are independent contractors counted under the 100-employee rule?

No, independent contractors are not counted.

How are workers from staffing agencies classified?

Staffing agencies hire workers and then coordinate placement at workplaces operated by “host” employers. Because the staffing agency is the legal employer of the worker, these workers are counted toward the staffing agency’s employee headcount, not the host employer’s.

Are some employees exempt from the ETS requirements?

Yes. Employees are not subject to ETS requirements if they work from home, work exclusively outdoors, or report to workplaces that do not have co-workers or customers present. However, these employees are still counted when determining whether an employer reaches the 100-employee threshold for ETS coverage.

What are the ramifications of non-compliance? 

Normally, employers face penalties up to $13,653 per violation for serious violations from OSHA. The penalty for failure to abate is $13,653 per day beyond the abatement date. These same penalties may apply to non-compliance with ETS after compliance dates.

When does the ETS  take effect?

The ETS technically went into effect on November 5, 2021 – the day it was published in the Federal Register. Enforcement was supposed to begin December 5, 2021 for all portions of the ETS other than testing and vaccination compliance date, which would have been January 4, 2022.

With current challenges to the OSHA ETS, the exact timeline for enforcement is up in the air.

What if I have operations in multiple states?

When operating in multiple states, you need to follow varying guidelines, standards, and timeframes applicable in each state. Let’s say you are operating in Alabama and Alaska. Alabama is a Federal OSHA state and Alaska is a State OSHA state. Therefore, you need to follow the standards and timelines of OSHA’s ETS for the operational unit located in Alabama and the State OSHA regulations for the operational unit located in Alaska.

Do remote employees need to comply with requirements?

Although remote employees count towards the 100-employee requirement (i.e. an employer with 75 onsite employees and 25 remote employees would come under the OSHA ETS),  ETS requirements, such as showing proof of vaccination and weekly testing, do not apply for remote employees.

Are employers required to collect proof of vaccination?

Yes. Under the ETS, employers will need to collect proof of vaccination from employees and maintain an updated, accurate record. An employee who does not produce proof of vaccination status must be treated as an unvaccinated employee.

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Having a vaccine tracker with a customizable dashboard that offers an integrated view of the enterprise’s vaccination data would be helpful in staying compliant with the OSHA COVID-19 vaccine mandate guidelines.

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You might have heard that there was some big news over the weekend concerning the OSHA ETS, which was stayed by the 5th Circuit Court in mid-November. Here are the three big takeaways, plus some insights for employers trying to decide what to do next.

1. The OSHA ETS stay has been lifted.

On Friday, December 17, the 6th Circuit Court of Appeals dissolved the stay that the 5th Circuit had placed on the OSHA ETS. That means that the ETS is back in force.

Shortly after that decision was issued, multiple plaintiffs filed emergency applications for an immediate stay of the ETS with the Supreme Court of the United States. Those applications will be reviewed by Justice Brett Kavanaugh, who is assigned to hear petitions from the Sixth Circuit Court of Appeals. Kavanaugh has several options:

• He has the authority to grant the petitioners’ applications and stay the ETS pending review of the entire Court.
• Given OSHA’s decision to delay compliance dates, he could refer the applications to the full Court for a decision.
• He could take no action on the applications pending review of the full Court.

The Supreme Court will try to avoid a scenario in which employers would take steps to implement the ETS only to have it invalidated later.

Although it is always difficult to predict how quickly a ruling might come, the speculation is that the Supreme Court will most likely take action in advance of January 10, 2022, to give employers some certainty.

2. The underlying merits of the ETS are still pending with the 6th Circuit.

The dissolution of the stay does not mean the ETS has passed. The final ruling is still pending with the 3-judge panel and even after their final ruling could still go to a full 6th circuit en banc review and decision.

3. Following the 6th Circuit ruling, an appeal may be made to SCOTUS.

Only after the final 6th Circuit ruling (either by the 3-judge panel or en banc) would an appeal be made to SCOTUS to make a final ruling. The Supreme Court may not issue on the underlying merits case, which it may choose to do. The Supreme Court often declines to hear cases.

What does all this mean for employers?

Here's a quick Q&A for employers wondering how to proceed in light of the OSHA ETS news:

• Should I start planning for ETS compliance? Legal experts strongly recommend getting a policy in place. That includes lining up testing resources if necessary, providing necessary communications to employees, collecting info on vaccination status and keeping roster, etc.
• What are the new timelines for compliance? The ETS is effective immediately. According to employment law firm Jackson Lewis, OSHA "will not issue citations for noncompliance before January 10, 2022. The agency also stated it will exercise its discretion and not issue citations for noncompliance with testing requirements under the ETS before February 9, 2022, if an employer is exercising reasonable, good faith efforts to come into compliance with the standard."
• What is meant by “…reasonable, good faith efforts…” to come into compliance with the ETS? It's unclear at this point, but a degree of reasonable diligence is required to get everything in motion.
• Other than the dates, has any changed regarding testing requirements, accommodations, or exemptions? Nothing else changed.
• Will the OSHA ETS override state rulings (e.g. Florida or Texas state requirements conflicting with OSHA)? This answer depends on whether any of the decisions on the merits of the ETS address preemption arguments.

Webinar: Learn how to navigate the mandates

With all the up's and down's concerning the fate of the OSHA ETS, some employers are taking a "wait and see" approach before committing to roll out a vaccine policy.​ What do top employment lawyers recommend? "Start planning now."

Learn more in our free webinar featuring top employment/labor law experts from Jackson Lewis P.C., and be sure to check out BP Logix's Vaccine Tracker application.

The Fifth Circuit Court of Appeals issued a ruling on Nov. 12 that blocks the Occupational Safety and Health Administration (OSHA) from enforcing its Emergency Temporary Standard (ETS) on COVID-19 Vaccination and Testing.

In the ruling, the Fifth Circuit argued that the ETS "exceeds the bounds of OSHA's statutory authority."

Under the ETS, employers with 100 or more employees would be responsible for:

1. Implementing and enforcing a workplace vaccination policy that either (a) requires mandatory vaccinations, or (b) allows employees to choose between vaccination or weekly COVID-19 testing.
2. Providing information to employees about the ETS, COVID-19 vaccines, and workplace vaccination policy.
3. Determining the vaccination status of all employees, obtaining valid proof of vaccination or weekly test results, and maintaining vaccination records to ensure compliance.
4. Reporting work-related COVID-19 fatalities and hospitalizations to OSHA. 

In response to the court order, OSHA issued the following statement:

"While OSHA remains confident in its authority to protect workers in emergencies, OSHA has suspended activities related to the implementation and enforcement of the ETS pending future developments in the litigation."

What employers need to know

Enforcement of OSHA's ETS was slated to begin on Dec. 5, so this recent ruling poses some interesting questions for employers that are currently exploring their options for employee vaccination tracking. Here are six key questions employers should be asking about Fifth Circuit's recent ruling on OSHA ETS.

1. Under the Fifth Circuit’s ruling, are employers still required to comply with the ETS? Can OSHA conduct audits or issue fines for non-compliance?  

The Fifth Circuit’s ruling functionally puts the ETS on a nationwide pause. While the ruling remains in effect, the federal government is prohibited from taking action to enforce the ETS. This means OSHA cannot conduct audits or issue fines until a decision is made. 

Although the ETS has been blocked, it’s important to note that the Fifth Circuit’s order is a temporary measure intended to maintain the status quo while appeals are pending. 

Because multiple parties have filed challenges to the ETS in multiple circuits, a consolidation proceeding known as a multi-circuit lottery will take place on November 16. This means the case may be transferred out of the Fifth Circuit before the court has a chance to issue a final ruling. Further, the federal government has the option of asking the US Supreme Court to dissolve this temporary stay. 

2. How long will it take to reach a final decision on this matter in the Court of Appeals or at the Supreme Court level? 

A final ruling from the Court of Appeals may take several weeks. It is also possible that the federal government will ask the US Supreme Court to dissolve this temporary stay. The Supreme Court could take much longer and if they were involved it would likely take place in Q1 2021.

3. What is the likelihood that OSHA's ETS will be diluted as a result of the legal challenges?

OSHA has the power to update and adopt new language to the original ETS. This power is intended to account for unconsidered items (e.g. booster shots), but it could also be used to make other changes, such as expanding the scope of exceptions or allowing additional time to meet the mandates.

However, it is unlikely that these changes would occur while challenges are pending. As part of its rulemaking procedures, OSHA is currently accepting comments, which the agency would take into consideration when finalizing a permanent standard.

4. If the Federal ruling is blocked, can states issue their own vaccine mandates for employers?  

Yes, states can and likely will issue their own vaccination mandates for employers.  

When OSHA enacts a federal-level emergency temporary standard, states are required to either (a) amend their standards to be identical or “at least as effective as” OSHA's new standard, or (b) demonstrate that their existing standard is “at least as effective” as the federal government’s new standard. 

However, some states may go a step further by adopting standards with even greater levels of protection and efficacy than what is required by OSHA. 

5. If the federal mandate holds up in the courts, how will OSHA enforce the mandate on such a large scale?  

OSHA has authority to review and determine non-compliance to the ETS mandate. They will likely focus their initial investigations on organizations that have willfully ignored the ETS. We also expect to see OSHA compliance investigations based on employee complaints about employer noncompliance.

6. Under the Fifth Circuit’s ruling, do employers still need to comply with the Centers for Medicare and Medicaid Services’ (CMS) interim final rule for healthcare workers and President Biden’s Executive Order 14042 on mandatory vaccinations for federal contractors?

The Fifth Circuit ruling has no impact on these rules. Employers should continue to adhere to these requirements as applicable.