Tag: COVID Vaccinations

The End of the COVID Public Health Emergency and Its Effect on Employee Benefit Plans

The COVID-19 public health emergency ends on May 11, 2023. The emergency resulted in two big changes to welfare plans: the relaxation of certain notification and timing requirements, and the requirement for plans to cover COVID testing and vaccination at no cost to plan participants. While the public health emergency ends May 11, 2023, plans have a grace period until July 11 to take certain actions and come into compliance with the normal rules.

Plan Sponsor Requirements

Before the grace period ends, plan sponsors will generally need to follow the rules that existed before COVID. Among the most important of these rules are the requirements for plan sponsors to:

  • Timely provide all notices, including those for HIPAA and COBRA.
  • Review COVID-related coverage under their employee assistance programs (EAPs) to determine if such coverage would be considered “significant medical care,” which can result in additional reporting and compliance obligations.
  • Review telehealth options to ensure they are properly integrated and provided by an entity that can comply with the post-COVID requirements. Telehealth rules were substantially relaxed during COVID. With telehealth now expected and utilized by more participants, getting telehealth right is more crucial than before.

Plan Sponsor Decisions

With the end of the public health emergency, plan sponsors must also make several important decisions with respect to their employee benefit plans:

  • Whether testing will continue free of charge or will be subject to cost sharing.
  • Whether non-preventative care vaccines for COVID will continue to be free of charge.
  • Whether costs for certain COVID-related services will continue to be posted.

As they are mostly based on what costs the plan sponsor or plan will cover going forward, these plan sponsor decisions are largely business-related. In the absence of a choice by the plan sponsor, the insurance provider will likely make a default choice. The important legal consideration is that the plan documents and employee communications should be consistent and accurately reflect the plan sponsor’s decisions.

Participant Requirements

In addition to the changes for plan sponsors, the end of the public health emergency will result in the reinstatement of a number of rules applicable to participants. Participants will need to:

Follow the HIPAA Special Enrollment timing rules.

Elect COBRA within the 60-day window for elections.

Make all COBRA payments timely.

Timely notify the plan of disabilities and qualifying events under COBRA.

Follow the timing limitations of their plans and insurance policies regarding filing claims, appeals, and external reviews.

Next Steps

First, plan sponsors should decide what COVID-related coverage will remain fully paid by the plan, if any. Some insurance companies are already starting to communicate with participants, and maintaining a consistent message will avoid unnecessary problems.

Second, plan sponsors should review their EAP and telehealth coverages for compliance with the rules that will soon be in effect. To the extent necessary, plan sponsors should update the documentation for their plans.

Finally, plan sponsors should consider a voluntary reminder communication to participants. Many rules have been relaxed over the last two years or so, and participants may be confused regarding the rules. A reminder may save stress for participants and those administering the plan, and will also serve to document the plan sponsor’s intention to properly follow the terms of the plan.

© 2023 Varnum LLP

For more healthcare legal news, click here to visit the National Law Review.

The OSHA Mandate — Supreme Court Oral Argument Preview

Tomorrow morning (Friday, January 7), the Supreme Court hears oral argument in the OSHA (10 a.m. EST) and CMS (11 a.m. EST) mandate cases.  (You can listen to the arguments live here.)  For the OSHA mandate, one group of petitioners consists of a coalition of twenty-seven States, led by Ohio, and the other consists of a coalition of business associations.  We’ve read the briefs, and here are our issues to look out for tomorrow:

Whether OSHA may only regulate occupational dangers.  The petitioners argue that because the OSH Act and OSHA regulations are all concerned with occupational hazards, OSHA cannot regulate against a virus presenting a risk to all Americans.  Meanwhile, OSHA argues that the OSH Act is not limited to dangers that are workplace-specific, especially given Congress’ previous endorsement of OSHA’s measures to encourage vaccination against bloodborne pathogens.

Whether COVID-19 is a “grave danger” that represents a “new hazard.”  The States argue that the OSH ACT limits “grave danger” to those “from exposure to substances are agents determined to be toxic or physically harmful,” connoting toxicity and poisonousness.  Thus, it cannot refer to airborne viruses that are “both widely present in society” and “non-life-threatening to a vast majority of employees.”  OSHA argues that the statute’s disjunctive phrasing allows for an ETS targeting viruses that are physically harmful, or a “new hazard, even if not technically “toxic” in nature.

Whether there is an “emergency” to justify the ETS.  The petitioners continue to argue that nothing significant has changed over the past year the country had been living with the virus to justify finding an emergency.  OSHA responds by pointing to problems presented by the return to work, the Delta variant, and COVID fatigue.

Whether the ETS is “necessary.”  The States argue that the OSH Act imposes a higher standard:  while other regulations may be merely “reasonably necessary or appropriate,” the Act requires emergency regulations to be “necessary”—which the States read as essential or indispensable.  According to the States, the delay between the issuance of the ETS and the time it was supposed to go into effect dooms any argument that it is necessary.  The business associations, for their part, stress that OSHA could have gone through notice and comment proceedings months ago.  In OSHA’s view, the statute is not nearly so narrow and it is enough that workplaces contribute substantially to the spread of the virus and that vaccines are the best way to fight COVID-19.

The scope of relief.  The petitioners obviously want to stay the entire mandate—both the vaccine and masking/testing requirements.  OSHA argues that any stay should be limited to the vaccine requirement.

Major-questions doctrine and federalism canon.  The petitioners argue that these canons of construction require Congress to speak clearly when delegating major economic and political questions to agencies that alter the balance between federal and state governments.  OSHA argues that neither of these canons apply and, in any event, Congress did speak clearly, as evidenced by the fact that it recently allocated $100 million to OSHA to carry out COVID-19 related worker protection activities.

Facts outside the administrative record.   While the OSHA and CMS mandates are supposed to be judged according to the record — which makes much of the factual discussion seem a little dated in this fast-moving pandemic — we’ll be interested to see whether the Omicron variant, the recent spike in cases, and other relatively recent developments show up at oral argument.

And, maybe, a few Constitutional issues.  While constitutional issues like the Commerce Clause and Non-Delegation Doctrine might appear tomorrow, we expect the statutory arguments to dominate the discussion—exactly as they did in the parties’ Supreme Court and Sixth Circuit briefing and in most Sixth Circuit opinions.

We’ll be interested to see how the opinions of Judge Stranch, Judge Larsen, Judge Sutton, and Judge Bush influence the Justices’ approach to the legal and factual questions.

© Copyright 2022 Squire Patton Boggs (US) LLP
For more about OSHA litigation, visit the NLR Coronavirus News section.

US to Expand Vaccination Requirement for Foreign National Travelers to Include All Land Border Crossers from Canada and Mexico in January

Starting Jan. 22, 2022, the Biden administration will require foreign national travelers engaged in essential travel to be fully vaccinated when crossing U.S. land borders or ferry terminals. Essential travel includes travel for work or study in the United States, emergency response, and public health. The new rules apply to foreign nationals; U.S. citizens and permanent residents may still enter the United States regardless of their vaccination status but are subject to additional testing requirements.

The new rules for essential travelers are in line with those that took effect Nov. 8, 2021, when the Biden administration lifted travel restrictions to allow fully vaccinated travelers engaged in non-essential (leisure) travel to enter the United States.

While much cross-border traffic was shut down in the early days of the COVID-19 pandemic, essential travelers have been able to travel unimpeded via land borders or ferry terminals. Starting Jan. 22, 2022, however, all foreign national travelers crossing U.S. land borders or ferry terminals – traveling for essential and non-essential reasons – must be fully vaccinated for COVID-19 and provide related proof of vaccination. Any exceptions to the vaccination requirement available to travelers at U.S. land borders are expected to be limited, just as exceptions currently available for air travel have been limited. See CDC guidance for details.

©2021 Greenberg Traurig, LLP. All rights reserved.
For more on vaccine requirements, visit the NLR Coronavirus News section.

CMS Requires COVID-19 Vaccine for Health Care Workers at all Facilities Participating in Medicare and Medicaid

On Nov. 4, 2021, the Centers for Medicare and Medicaid (CMS) released a new Interim Final Rule (IFR) regarding staff vaccination at facilities that participate in the Medicare and Medicaid programs. The IFR requires covered employers to ensure that staff receive their first dose no later than Dec. 5, 2021 and achieve full vaccination no later than Jan. 4, 2022.

The vaccine rule that was also released on Nov. 4, 2021 by the Occupational Safety and Health Administration (OSHA) does not apply to employees of health care entities who are covered under the CMS IFR. However, employees of health care providers who are not subject to the CMS IFR may be subject to the OSHA vaccine rule if the facility has more than 100 employees. For more information on the OSHA vaccine rule, please click here.

Justification for the Rule

CMS cited a number of reasons for the IFR, including the risk unvaccinated staff pose to patients, reports of individuals foregoing health care due to concerns of contracting COVID-19 from health facility staff, disrupted health care operations due to infected staff, and low vaccination rates among health care staff.

Scope of Coverage

The requirements of the IFR apply to health care facilities that participate in Medicare and Medicaid and that are subject to Conditions or Requirements of Participation, including but not limited to:

  • Ambulatory surgical centers;
  • Hospices;
  • Hospitals, such as acute care hospitals, psychiatric hospitals, hospital swing beds, long-term care hospitals, and children’s hospitals;
  • Long-term care facilities;
  • Home health agencies;
  • Comprehensive outpatient rehabilitation facilities;
  • Critical access hospitals;
  • Home infusion therapy suppliers; and
  • Rural health clinics/federally qualified health centers.

While the IFR does not directly apply to physician offices, which are not regulated by CMS Conditions or Requirements of Participation, physicians may nevertheless be required to vaccinate as a result of their relationships with other health care entities. For example, the IFR requires hospitals to implement policies and procedures to ensure “individuals who provide care, treatment, or other services under contract or by other arrangement” are fully vaccinated.

Covered Personnel

The IFR requires vaccinations for staff who routinely perform care for patients and clients inside and outside of the facility, such as home health, home infusion therapy, hospice, and therapy staff. CMS’s vaccination requirement also extends to all staff who interact with other staff, patients, residents, or clients, at any location, and not just those who enter facilities. However, staff who provide services 100% remotely—that is, staff who never come into contact with other staff, patients, residents, or clients—are not subject to the IFR vaccination requirements. Additionally, providers and suppliers are not required to ensure IFR vaccination compliance of one-off vendors, volunteers, or professionals, such as (a) those who provide infrequent ad hoc non-health care services (e.g. annual elevator inspectors), (b) those who perform exclusively off-site services (e.g. accounting services), or (c) delivery and repair personnel.

Definition of Full Vaccination

CMS considers “full vaccination” as 14 days after receipt of either a single-dose vaccine (such as the Johnson & Johnson vaccine) or 14 days after the second dose of a two-dose primary vaccination series (such as the Pfizer or Moderna vaccines). At this time, CMS is not requiring the additional (third) dose of mRNA vaccine for moderately/severely immunosuppressed persons or the “booster dose” in order for staff to be considered “fully vaccinated.” Additionally, CMS considers individuals receiving heterologous vaccines—doses of different vaccines—as satisfying the “fully vaccinated” definition so long as they have received any combination of two doses. In order to gauge compliance, CMS is requiring that providers and suppliers track and securely document the vaccination status of each staff member as well as vaccine exemption requests and outcome. The IFR does not specify that weekly testing, masking, and social distancing are an alternative to vaccination, meaning employers must ensure all employees are either (1) fully vaccinated or (2) exempted under a permissible exemption.

Exemptions

The IFR explicitly provides that employers must continue to comply with anti-discrimination laws and civil rights protections which allow employees to request and receive exemption from vaccination due to a disability, medical condition, or sincerely held religious belief or practice. Exemptions should be provided to staff with recognized medical conditions for which a vaccine is contraindicated as a reasonable accommodation under the Americans with Disabilities Act. For exemptions for a sincerely held religious belief or practice, CMS encourages health care entities to refer to the Equal Employment Opportunity Commission’s Compliance Manual on Religious Discrimination. Despite the ability to provide an exemption, CMS states that exemptions may be provided to staff only to the extent required by law, and that requests for exemption should not be provided to those who seek solely to evade vaccination. CMS also notes at length that the Food and Drug Administration considers approved vaccines safe. Accordingly, CMS will likely be unwilling to excuse provider and supplier noncompliance due to employees refusing vaccination based on fears about safety.

Penalties

Although the IFR does not identify specific penalties for non-compliance, CMS is expected to use enforcement tools such as civil money penalties, denial of payment for new admissions, or termination of the Medicare/Medicaid provider agreement. CMS will utilize State Survey Agencies to review compliance with the IFR through standard recertification surveys and complaint surveys. Noncompliance with the IFR will be addressed through established classification channels of “Immediate Jeopardy,” “Condition,” or “Standard” deficiencies.

Preemption

While CMS recognizes that some states and localities have established laws to prevent mandatory compliance with vaccine mandates, CMS ultimately considers the Supremacy Clause of the United States Constitution as preempting inconsistent state and local laws as applied to Medicare- and Medicaid-certified providers and suppliers.

© 2021 Dinsmore & Shohl LLP. All rights reserved.
For more updates on COVID-19, visit the NLR Coronavirus News section.

Immigration and Compliance Briefing: Fall Travel & COVID-19 Policy Update

On October 25, 2021, the Biden Administration issued a Presidential Proclamation to lift the travel bans which currently restrict entry into the U.S. directly from specific geographic areas (for a full list of restricted countries, see our prior client alert here), to be effective November 8, 2021. Instead of banning entry from specific locations abroad, the U.S. will utilize vaccine status-based restrictions for incoming travelers entering the country as noncitizen nonimmigrants (i.e., temporary visa holders or visa-free travelers). Once the new rules go into effect, most travelers will be required to provide proof of being fully vaccinated for COVID-19 prior to boarding an airplane, regardless of recent travel history (“fully vaccinated” refers to individuals who received the final dose of the COVID-19 vaccine more than 14 days prior).

Currently, the list of acceptable vaccines approved/authorized by the U.S. Food and Drug Administration (FDA) and World Health Organization (WHO), are as follows:

  • Pfizer-BioNTech

  • Moderna

  • Johnson & Johnson

  • Oxford-AstraZeneca/Covishield

  • Sinopharm

  • Sinovac

  • Mixed doses comprising of any two authorized/approved vaccines

As additional vaccines receive authorization/approval by either the FDA or WHO, it is anticipated that they will be added to the list of acceptable vaccines. In addition, the U.S. Centers for Disease Control will implement contact-tracing protocols. Mask mandates for airlines and airports, as well as the pre-travel negative COVID-19 test requirements, will remain in place until at least mid-January.

Exceptions include, but are not limited to, the following types of noncitizen nonimmigrants:

  • Certain noncitizen nonimmigrants traveling in an official capacity (i.e., foreign government officials and their family, individuals entering pursuant to a NATO visa classification, or individuals traveling pursuant to the United Nations Headquarters Agreement)

  • Children under the age of eighteen (18) years

  • Individuals participating in COVID-19 clinical trials*

  • Individuals unable to receive the vaccine due to a medical contraindication, as determined by the CDC

  • Individuals unable to receive the vaccine due to unavailability in their country of residence who are seeking to enter the U.S. on a nonimmigrant visa except B-1/B-2

  • Members of the U.S. Armed Forces

  • Sea crew members

  • Individuals whose entry is in the national interest

  • Individuals granted exceptions for humanitarian or emergency reasons

*The CDC will determine the qualifying criteria for individuals seeking to enter under this exception.

In addition to the restrictions above, all unvaccinated travelers traveling to the U.S. must show proof of a negative COVID-19 test taken within one day of travel. This requirement includes unvaccinated U.S. citizens and Lawful Permanent Residents (“green card” holders).

Vaccinated U.S. citizens and Green Card holders must show proof of a negative COVID-19 test within three days of travel.

Finally, additional measures may be required for certain types of travelers, including self-quarantine and vaccination within sixty (60) days of entry.

This policy will remain in place for an initial period of sixty (60) days and may be renewed on a monthly basis after that.

U.S. Land Border Updates

The Department of Homeland Security (DHS) announced that it will lift travel restrictions for land and ferry border crossings from Canada and Mexico in two phases, beginning November 8, 2021. Instead of keeping the land borders closed to nonessential travel, the Biden administration will implement the same policy as for air travel. Beginning November 8, nonessential travel will be permitted for fully vaccinated individuals, as described above. Nonessential travel will continue to be permitted regardless of vaccination status. However, beginning in early January 2022, all individuals entering the U.S. via the land border or ferry will be required to be fully vaccinated. This decision will permit nonessential travel via the land border between Canada and Mexico for the first time since March 21, 2020.

Vaccine Requirement for Individuals Seeking Permanent Immigrant Status

Effective October 1, 2021, applicants for immigrant status (i.e., a “green card”) in the U.S. who are subject to submitting Form I-693, Report of Medical Examination and Vaccination Record must be fully vaccinated as described above against COVID-19, before a civil surgeon designated by the Immigration Service can complete and sign the Form I-693 medical exam.

Waivers may be granted in certain circumstances, including where the COVID-19 vaccine is:

  • Not age appropriate;

  • Contraindicated due to a medical condition;

  • Not routinely available where the civil surgeon practices; or

  • Limited in supply and would cause significant delay for the applicant to receive the vaccination.

    © 1998-2021 Wiggin and Dana LLP

For more articles on COVID-19 Immigration, visit the NLR Immigration section.

You Can Require It, But It’ll Cost You: COVID Vaccinations and Mandatory Pay

On April 21, 2021, Chicago became the latest locale to require employers that mandate COVID-19 vaccinations to compensate certain employees for time spent getting vaccinated. While the new ordinance does not go as far as legislation in other parts of the country, it does create new obligations for employers, whether vaccinations are mandated or merely encouraged.

Mandated Vaccines

Under the new ordinance, employers that require their Chicago employees to receive the COVID-19 vaccine must compensate those employees at their regular rates of pay, up to four hours per dose, if the vaccination takes place during an employee’s regular working hours. Employers also are prohibited from requiring employees to receive vaccinations outside working hours, or requiring employees to use any available paid sick leave or vacation time toward those hours.

While the ordinance does not require employers mandating vaccinations to pay employees for the time spent being vaccinated outside working hours, employers should be mindful of the Illinois Department of Labor’s position that employees who are required to obtain a vaccination must be compensated for their time spent being vaccinated, regardless of whether that is during or outside of working hours.

Non-Mandated Vaccines

The ordinance also creates some new obligations for employers that merely encourage (but don’t mandate) COVID-19 vaccinations. These employers also cannot require that employees choosing to receive a vaccination do so outside of working hours, and employees who choose to use any available paid sick leave or paid time off must be allowed to do so.

Notably, the ordinance does not create a new bank of paid time off for employees to receive their vaccinations. Therefore, employees who obtain their vaccinations during working hours but do not have any available paid sick leave or paid time off can be required to take the time off as unpaid. The ordinance also prohibits all employers from retaliating against any employee who chooses to be vaccinated during working hours.

Other Locales

The relative restraint of the Chicago ordinance is a marked difference from the approach in other parts of the country. For example, last month the state of New York enacted a new law requiring all employers to provide employees with a “sufficient period” of paid time off to receive their COVID-19 vaccinations, not to exceed four hours per injection, through the end of 2021. In Colorado, the state’s new Public Health Emergency Leave provides employees with up to 80 hours of paid sick leave for, among other uses, “preventative care concerning a communicable illness that is the cause” of the applicable public health emergency – at the moment, COVID-19.

And then there’s California, which requires employers with 26 or more employees to provide supplemental paid sick leave, retroactive to January 1, 2021, for uses that include attending a vaccine appointment and for periods an employee cannot work or telework due to vaccine-related side effects.

More state and local laws of this nature likely are on the way. However, employers operating in places without leave laws specific to COVID-19 vaccinations should still be mindful that already-existing leave laws may apply to time spent obtaining vaccinations. Most state and local paid sick leave laws allow the use of sick leave for preventative care and for the recovery from illness – which likely would apply to obtaining a vaccination and recovering from the side effects of that vaccination.

Tax Credits

That said, keep in mind that with the enactment of the American Rescue Plan Act of 2021 (ARPA), employers with fewer than 500 employees that voluntarily choose to extend paid sick leave under the Families First Coronavirus Response Act (FFCRA) beyond its original December 31, 2020 expiration date can claim a payroll tax credit for any FFCRA paid sick leave used by employees to obtain or recover from COVID-19 vaccinations. These tax credits are available to eligible employers for payments made from April 1, 2021 through September 30, 2021 in respect of such leave.

As employers decide whether to mandate vaccinations now or down the road, they should keep these evolving requirements in mind, and they should consult with experienced legal counsel to ensure compliance with applicable laws.

Legal vs. Practical

Of course, putting aside legalities, there is a practical aspect of these types of decisions. While vaccine availability continues to expand, many people in many parts of the country are still struggling to get vaccine appointments. If those appointments happen to fall during working hours, employers should remember that a little understanding may go a long way, and the benefits of a more fully vaccinated workforce – and populace – will far outweigh any short-term effects of an employee’s absence from the workplace for a brief period.

© 2021 Much Shelist, P.C.

ARTICLE BY Matthew J. Feery and Sheryl Jaffee Halpern of Much Shelist, P.C.
For more articles on vaccinations and mandatory pay, visit the NLR Coronavirus News section.