Coronavirus / COVID-19 Response Team - UPDATE: January 28, 2021 - Miller Johnson

UPDATE:
January 28, 2021

                          Coronavirus / COVID-19
                          Response Team                   1

                         Tim Gutwald

            © 2021 Miller Johnson. All rights reserved.       1

The materials and information have been prepared for
informational purposes only. This is not legal advice, nor
intended to create or constitute a lawyer-client relationship.
Before acting on the basis of any information or material,
readers who have specific questions or problems should
consult their lawyer.

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1. HR Issues and the Vaccine
  Requiring The Vaccine
  Incentivizing The Vaccine
2. Risk Management Issues
  Liability and Immunity
  PREP Act
  State Immunity
3. HIPAA/Confidentiality
  OCR Enforcement Discretion

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 Requiring
The Vaccine

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 Vaccine is NOT a Medical Exam
  Private employers CAN mandate the employees receive the vaccine
   with several exceptions and considerations
 IF the vaccine is mandatory and provided by the employer the
 screening questions are covered by the ADA
  Must be job-related and consistent with business necessity
  Employer must show that it would be a direct threat to the employee
   or others not to receive the vaccine

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 Employer can request proof of vaccine
 Maintain in confidential employee health file

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 Employers must consider                 Pregnant/breast feeding
 ADA and religious                         employees should also not
 accommodations                            be mandated
  Have an accommodation                  Must consider
   process ready to go                     accommodations if an
  If employee has a legitimate            employee refuses to get
   disability or sincerely held
   religious belief, analysis will
                                           vaccinated
   turn to direct threat analysis
                                         Check out our webinars on Dec 18, 2020 &
                                               Jan 27, 2021 for more analysis:
                                     https://millerjohnson.com/covid-19-webinar-ppts/

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               Incentivizing
                The Vaccine

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Legal Options for
 Employee Communication
                                             Incentivizing Vaccine
        Campaign
 FAQs                                  Be careful not to cloak a
 Leadership getting it                  mandate as an incentive
 Vaccinatewestmi.com                   PTO for missed work time to get
  FAQs                                  it
  Flyer from Kent County Health        No longer pay for COVID-19
   Department                            related absences (post FFCRA,
                                         check state law)

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 Houston health system paid $500 as “Hope Bonus”
 Others have offered a raffle prizes
 Trader Joe’s, Instacart and Dollar General have all offered
 incentives
  $25 (Instacart); PTO (Trader Joes, Dollar General)

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 Think about if you will pay the incentive to people who
  already received the incentive
 Think about timing of the incentive
 Think about messaging

             Check out our webinar on Jan 27, 2021 for more analysis:
               https://millerjohnson.com/covid-19-webinar-ppts/

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 Can’t have your own employees volunteer to do a job they
  are otherwise paid to do
   Employees can’t staff your clinics
 What about non-employees who want to volunteer?
 Be sure to have volunteers sign forms, get health screening,
  etc.

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 In order to receive distributions of the vaccine, providers
  must sign a Provider Agreement
   Must agree to comply with the ACIP recommendations
   Must agree to report information to the state (MCIR)
   Agree not “sell or seek reimbursement” for vaccine
   Can charge fee to administer the vaccine
   Must administer the vaccine regardless of ability to pay
 Potential penalties for breaching the agreement:
   Inability to receive future vaccine distributions
   Fines, criminal charges, False Claims Act case

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 PREP Act                              CARES Act
  Provides immunity for the               Immunity for provision of health
   administration of                        care services as a volunteer
   “countermeasures”                       Provides immunity to volunteer
  Provides immunity to:                    healthcare professionals
   manufacturers, distributors,         Federal Volunteer Act
   program planners and                    Volunteers of nonprofit and
   “qualified persons” (typically          governmental entities
   licensed health care providers)
                                        Does not protect: willful
                                         misconduct, criminal conduct,
                                         gross negligence, etc.

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 Countermeasure
  May include medical product used for COVID-19 that is approved,
   cleared or licensed by the FDA, authorized by a EUA
  Includes antiviral drugs, certain respiratory protective devices,
   immunity
 Covered persons
  Program Planners- entities involved in planning, administering or
   supervising programs for distribution of a countermeasures
  Qualified persons- authorized to prescribe, administer or dispense
  Volunteers- make sure they still have valid license, certifications

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 Claim must be for a “loss”
 Loss must have a “causal relationship” with the
 administration or use
  Must pertain to…prescribing, administering, licensing or using a
  covered countermeasure.

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 Case Law
  Using a countermeasure somewhere in a facility does not preclude all
   claims
  Failure to immunize may lead to a lack of legal immunity.
 Guidance
  HHS has said it precludes claims alleging negligence, management of
  a distribution program or site, slip-and-fall injury, car accident. Must
  be directly related to the countermeasure activities at the site.

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 Immunity for employees,            Providing Emergency Care
 agents, of state and local             Health care providers without an
 governments                             existing duty
  MDHHS, local health                  Can’t be compensated
   departments                       Free immunization programs
  Immunity extends to                and free health care
   employees, officers,                Limited to health departments,
   volunteers, authorized                non-profits that don’t charge for
   representatives                       care
                                        Open question as to whether
                                         “free” allows you to bill
                                         insurance
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 Cannot bill for vaccine itself or syringes and other related
  supplies
   Remember…this is a term in the provider agreement
 Can bill for the cost of administering the vaccines
 Cannot charge patients co-pays or other amounts
   In other words, no balance billing
 Cannot refuse to give vaccine to people who can’t pay
  (uninsured)
 Coverage- Medicare and Medicaid

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 Coverage
  Medicare and Medicare Advantage
  Medicaid- No cost sharing during the public health emergency
  Private Plans- most plans must cover without cost-sharing and out-of-
   network rates cannot be “unreasonably low.”
  Uninsured- can see reimbursement through the Provider Relief Fund

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 Vaccination information is PHI (so are COVID tests) when
  administered by a covered entity.
 Be careful with vaccination records of your own employees
   Cannot share PHI with HR without authorization
 Be careful with vaccination records of others
   Can’t disclose to employers without authorization
 From a HR perspective you can:
   Ask the employee
   Get an authorization upfront or post-vaccination

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 You are required to report vaccine administration to MCIR
 The Office of Civil Rights has said it will exercise
  enforcement discretion for use of online or web-based
  scheduling applications
 Even if HIPAA does not apply, consider how to store the
  information.

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 Standing Orders and documentation
 Remember to report all immunization to MCIR
 Vaccine Redistribution
 Emergency Use Authorization compliance
   Must communicate certain information to patients/caregivers
   Must provide a vaccination card
 Adverse event reporting- Vaccine Adverse Events Reporting
  System
 MDHHS provider specific resources
   Storage, billing, product information, vaccine administration, FAQs

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Advantage Benefits Group Webinar
 Thursday, January 28, 2021 at 1pm

 COVID-19 Vaccine Insights:
 Speakers include Pfizer Head of
 Vaccines, Alejandro Cane, MD

 Register here:
 https://register.gotowebinar.com/re
 gister/7499741737750266639

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