The Biden Plan Takes Wings - Feds issue OSHA and CMS vaccine guidance, update guidance for contractors

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The Biden Plan Takes Wings - Feds issue OSHA and CMS vaccine guidance, update guidance for contractors
The Biden Plan Takes Wings
Feds issue OSHA and CMS vaccine guidance,
update guidance for contractors
LOCKTON CORONAVIRUS ADVISORY PRACTICE

Nov. 10, 2021
The Biden Plan Takes Wings - Feds issue OSHA and CMS vaccine guidance, update guidance for contractors
Introductions, housekeeping   Ed Fensholt, J.D.
                                      SVP, Director,
      and a bit of context          Compliance Services

KC: 82489
The Biden Plan Takes Wings - Feds issue OSHA and CMS vaccine guidance, update guidance for contractors
A bit of context …
• The rise of the COVID-19 delta variant
  − As of mid October 2021, in the U.S. alone:
     ▪ Over 44 million COVID-19 cases
     ▪ 3 million new COVID-19 related hospitalizations
     ▪ 720,000 COVID-19 deaths

                                                         LOCKTON COMPANIES |   3
The Biden Plan Takes Wings - Feds issue OSHA and CMS vaccine guidance, update guidance for contractors
A bit of context …
• Sept. 9: Pres. Biden announced plan to accelerate vaccinations of the unvaccinated
  − Federal contractors: Vaccine mandate
     ▪ Guidance issued Sept. 24 and Nov. 4 (see our alerts here and here)
  − Healthcare providers participating in Medicare/Medicaid programs:
    Vaccine mandate
     ▪ Guidance issued by CMS on Nov. 5 (see our alert)
  − Employers with at least 100 employees: Either mandate the vaccine or require
    weekly proof of negative COVID-19 test
     ▪ Guidance issued by OSHA on Nov. 5 (see our alert)
     ▪ Federal appeals court imposes at least a temporary stay on Nov. 6, with highly
       accelerated briefing schedule, suggesting quick decision on legality of the
       OSHA mandate

                                                                        LOCKTON COMPANIES |   4
The Biden Plan Takes Wings - Feds issue OSHA and CMS vaccine guidance, update guidance for contractors
Agenda
             The OSHA mandate
Quick update on federal contractor guidance
     Paula Day, VP, Director, HR Compliance Consulting

       More on the OSHA mandate
         Dr. Shealynn Buck, SVP, Medical Director

 The CMS mandate (and a HIPAA nugget)
      Ed Fensholt, SVP, Director, Compliance Services

       Communications perspective
        Julie Gibson, EVP, Director, Communications
The Biden Plan Takes Wings - Feds issue OSHA and CMS vaccine guidance, update guidance for contractors
Federal OSHA
Emergency Temporary          Paula Day, J.D.
                               VP, Director

Standard                 HR Compliance Consulting

EFFECTIVE NOV. 5, 2021
The Biden Plan Takes Wings - Feds issue OSHA and CMS vaccine guidance, update guidance for contractors
OSHA ETS: Legal challenges
Current legal challenges in the Fifth, Sixth, Seventh, Eighth, Eleventh and District of
Columbia Federal Circuits

                                                                            LOCKTON COMPANIES |   7
The Biden Plan Takes Wings - Feds issue OSHA and CMS vaccine guidance, update guidance for contractors
OSHA ETS: Federal vs. State
Federal OSHA                                               State OSH plans
(private-sector employers)                                 (private-sector and state and local
                                                           government workers)
•   ETS is effective Nov. 5, 2021
                                                           •   These states must notify Federal OSHA of
•   Applies to the following states:
                                                               what action they plan to take within 15
    Alabama         Arkansas        Colorado                   days and have 30 days (until Dec. 5) to
    Connecticut     Delaware        District of Columbia       adopt the federal OSHA ETS or alternative
    Florida         Georgia         Idaho                      standards/regulations at least as effective
    Illinois        Kansas          Louisiana                  as the ETS
    Maine           Massachusetts   Mississippi                Alaska           Arizona          California
    Missouri        Montana         Nebraska                   Hawaii           Indiana          Iowa
    New Hampshire   New Jersey      New York                   Kentucky         Maryland         Michigan
    North Dakota    Ohio            Oklahoma                   Minnesota        Nevada           New Mexico
    Pennsylvania    Rhode Island    South Dakota               North Carolina   Oregon           South Carolina

    Texas           West Virginia   Wisconsin                  Tennessee        Utah             Vermont
                                                               Virginia         Washington       Wyoming

                                                                                             LOCKTON COMPANIES |   8
The Biden Plan Takes Wings - Feds issue OSHA and CMS vaccine guidance, update guidance for contractors
OSHA ETS: The timeline
                                              Dec. 5, 2021
                                              Deadline for covered employers to
                                              comply with all but testing
                                              requirement.
Nov. 5, 2021                                                                                 May 5, 2022
                                              Date by which state OSH plans are to
Federal OSHA ETS Effective Date               implement the federal standard or              OSHA ETS six-month period expires
                                              more stringent requirements.*

                       Nov. 20, 2021                                 Jan. 4, 2022
                       State-Plan states must notify OSHA of         Federal OSHA ETS: Deadline for
                       intentions.                                   employees to be fully vaccinated or
                                                                     alternative testing begins

                                                                                                             LOCKTON COMPANIES |   9
The Biden Plan Takes Wings - Feds issue OSHA and CMS vaccine guidance, update guidance for contractors
OSHA ETS: Are you a covered employer?
  Meeting the 100-employee threshold:
  •   All employees across the U.S. regardless of where the work is performed and
      vaccination status
  •   Remote, part-time, seasonal and temporary (not staffing) employees
  •   Not independent contractors

It does not matter at what point an employer has 100 or more employees:
1. An employer is covered for the duration of the ETS once it has 100 or more
   employees
2. If the employer drops below 100 employees at any point after Nov. 5, 2021, the ETS
   still applies for the duration of the effective period
3. If the employer does not reach 100 employees until after Nov. 5, 2021, the ETS
   applies as of that date for the duration of the ETS

                                                                       LOCKTON COMPANIES | 10
OSHA ETS: Are you a covered employer?
    SCENARIOS

01                                  02                                03                              04
FRANCHISES                          RELATED ENTITIES                  STAFFING AGENCIES               MULTIEMPLOYER
Franchisor and franchisee are       Two or more entities may be       Only count the employees        WORK SITE
separate entities for determining   regarded as a single employer     placed at host employer; host   Each entity only counts their
applicability of the ETS.           for purposes of OSHA if they      employer does not count         own employees.
                                    handle “safety matters” as a      staffing employees.
                                    single company in which case
                                    the employees of all entities
                                    making up the integrated single
                                    employer must be counted.

                                    •   How interrelated are the
                                        entities?

                                    •   How have you responded to
                                        prior OSHA inspections?

                                    •   How are current policies
                                        developed?

                                                                                                              LOCKTON COMPANIES | 11
OSHA ETS: Which
employers are not covered?
• Workplaces covered by the federal
  contractor vaccine mandate or the CMS
  vaccine mandate
• Employers subject to OSHA’s Healthcare ETS
  (but the employer may be covered by both
  sets of ETS)

                                               LOCKTON COMPANIES | 12
OSHA ETS: Which
employees are not covered?
• Employees reporting to a workplace with no
  contact with other workers or customers
• Remote workers who never work on-site or
  meet with co-workers or customers
  (periodically reporting to the work site would
  trigger testing if the employee is not fully
  vaccinated)
• Exclusively outdoor workers which have no
  work time indoors other than de minimis
  − Construction sites (sometimes, not always)
  − Landscaping employees (so long as
    employees do not share a vehicle)

                                                   LOCKTON COMPANIES | 13
OSHA ETS: What is required?
BY DEC. 5, 2021:
 • Establish a written policy on vaccination (mandate vaccine or testing alternative) or modify existing policy to
   comply with ETS.
 • Determine vaccination status of employees, obtain proof of vaccination, maintain records and compile roster
   of vaccination status (including accommodation information).
 • Provide employees with paid time off for vaccinations (4 hours per dose) and paid leave for reasonable
   recovery of vaccine related illness (up to 2 days per dose).
 • Require employees to provide notice of a positive COVID-19 test or COVID-19 diagnosis.
 • Remove any employee testing positive for COVID-19 or diagnosed with COVID-19.
 • Require employees who are not fully vaccinated to wear face coverings indoors or when in a vehicle with
   another employee.
 • Provide employees with information about the ETS; workplace policies/procedures; facts about vaccination
   efficacy, safety and benefits; protections against retaliation and discrimination; and laws that provide for
   criminal penalties for knowingly supplying false documentation.
 • Report work-related COVID-19 fatalities to OSHA within 8 hours and work-related COVID-19 in-patient
   hospitalizations within 24 hours.
 • Make certain records available to employees and OSHA.

Multistate operations may potentially have varying requirements and deadlines.

                                                                                                  LOCKTON COMPANIES | 14
OSHA ETS: Required policy options

 Option 1                                 Option 2
 Mandatory Vaccination Policy             COVID-19 Vaccination, Testing and
                                          Face Covering Policy

           Policy templates available here.

                                                                   LOCKTON COMPANIES | 15
OSHA ETS: Required policy options
A Mandatory Vaccination Policy must be in writing, identify the effective date and include the following:
•   Require each employee to be fully vaccinated (including new employees as soon as practicable), other than
    those employees:
    − For whom a vaccine is medically contraindicated
    − For whom medical necessity requires a delay in vaccination
    − Entitled to a reasonable accommodation under the ADA or Title VII
    [Policy must include information on weekly testing and face covering requirements applicable to these
    employees]
•   Information on determining the employee’s vaccination status, how the information will be collected and
    the deadline
•   Paid time and sick leave for vaccination purposes
•   Notification of positive COVID-19 test and removal of COVID-19 positive employees from the workplace
•   Identify the information to be provided to employees and how the employer is making that information
    available
•   Disciplinary action for employees who do not abide by the policy
•   Procedures for compliance and enforcement

                                                                                                LOCKTON COMPANIES | 16
OSHA ETS: Proof of vaccination
Proof should include:                         Proof of vaccination status
                                              demonstrated by:
1.   The employee’s name
                                              •   The record of immunization from a
2.   The type of vaccine administered
                                                  healthcare provider or pharmacy
3.   The date(s) of administration and        •   A copy of the COVID-19 Vaccination
4.   The name of the healthcare                   Record Card
     professional(s) or clinic site(s) that   •   A copy of medical records documenting
     administered the vaccine                     the vaccination
                                              •   A copy of immunization records from a
                                                  public health, state, or tribal
                                                  immunization information system
                                              •   A copy of any other official
                                                  documentation that contains the type
                                                  of vaccine administered, date(s) of
                                                  administration, and the name of the
                                                  healthcare professional(s) or clinic
                                                  site(s) administering the vaccine(s)
                                                                            LOCKTON COMPANIES | 17
OSHA ETS: Proof of
vaccination
What if an employee states their vaccination
record is lost or stolen?
• The employee must attempt to obtain a copy
  from their healthcare provider or the clinic.
• After an attempt is made to obtain a copy, an
  employee may provide an attestation as a last
  resort.
  − Sample attestation

                                                  LOCKTON COMPANIES | 18
OSHA ETS: When is paid time off required?

 01                                         02                                    03
 FOR COVID-19                               SIDE EFFECTS FROM                     REMOVAL FOR COVID-19
 VACCINATION                                VACCINATION                           POSITIVE TEST OR
 •   Up to four hours per dose              • “Reasonable time” to recover        DIAGNOSIS
     (regardless of whether vaccine is        from illness following dose
     mandated)                                (two days is reasonable, but        • Employee should work remotely
 •   Only applies for employees who get       additional leave may be               if possible
     vaccinated during regular working        required)                           • Paid time off is not required
     hours
                                            • Can require the use of existing
 •   This is in addition to existing paid     sick pay or PTO                     • A collective bargaining
     leave                                                                          agreement may require paid
                                            • Cannot require the use of             time off
 •   No reimbursement for                     vacation pay to cover this time;
     incidental costs                         rather, must provide sick time if   • Employees should be permitted
 •   Not required to pay retroactively        none accrued and unused               to use accrued paid leave

NOTE: State or local laws may also require paid time off for one or more of these reasons.

                                                                                                   LOCKTON COMPANIES | 19
OSHA ETS: Face covering
requirement
• Compliance begins Dec. 5, 2021, for those employees
  who are not fully vaccinated                                Exceptions:
                                                              • When an employee is alone
• A “face covering” must:                                       in a room with floor to
  − Completely cover the nose and mouth                         ceiling walls and a closed
                                                                door
  − Be made of two or more layers of a breathable fabric
                                                              • For a limited time while the
    that is tightly woven                                       employee is eating or
  − Be secured to the head with ties, ear loops, or elastic     drinking at the workplace or
    bands that go behind the head (gaiters can be worn          for identification purposes
    if they have two layers of fabric or are folded to make   • When the employee is
    two layers)                                                 wearing a respirator or
                                                                facemask
  − Fit snugly over the nose, mouth and chin with no
    large gaps                                                • Where the employer can
                                                                show that the use of face
  − Be made of a solid piece of material without slits,         coverings is not feasible or
    exhalation valves, visible holes, punctures or other        creates a greater hazard
    openings
                                                                         LOCKTON COMPANIES | 20
OSHA ETS: COVID-19 testing requirement

       Unvaccinated employees who report to a workplace where there are
       other individuals (or who interact with coworkers or customers outside
       of the home) must be tested once weekly.

       Unvaccinated employees must provide documentation of the most
       recent COVID-19 test result no later than the seventh day following
       the date the employee last provided a COVID-19 test result.

       Unvaccinated employees who report to the workplace less frequently
       than once every seven days must be tested for COVID-19 within seven
       days of returning to the workplace and the employee must provide
       documentation of the test to the employer.

                                                                  LOCKTON COMPANIES | 21
OSHA ETS: COVID-19 testing
• Testing begins Jan. 4, 2022, for employees who are not fully vaccinated.
• Employers are not required to pay for the testing (but may choose to do so) unless:
  − Testing is offered as an accommodation.
  − Applicable state law requires employers to bear this expense.
  − Collective bargaining agreement requires employer to pay.
• It’s unclear whether employees must be compensated for time spent taking tests.
• Employers must maintain a record of each test result required to be provided by each
  employee pursuant to this ETS or obtained during tests conducted by the employer —
  keep these records confidential.
• Employees have a 90-day “pass” from testing after a positive COVID-19 test or
  diagnosis.
• Accommodations may be required, if requested.
• In the event of testing supply issues or laboratory problems, OSHA will look at what
  efforts employers made to comply.

                                                                             LOCKTON COMPANIES | 22
OSHA ETS: COVID-19 positive test
Employers must immediately remove from the workplace any employee who tests
positive for COVID-19 or is diagnosed with COVID-19 and keep the employee
removed until the employee:
• Receives a negative result on a COVID-19 nucleic acid amplification test (NAAT)
  following a positive result on a COVID-19 antigen test, if the employee chooses to
  seek a NAAT test for confirmatory testing.
• Meets the return-to-work criteria in CDC’s Isolation Guidance.
• Receives a recommendation to return to work from a licensed healthcare provider.

  NOTE: The ETS does not require that unvaccinated employees be removed from
  the workplace if they’ve been in close contact with a COVID-19 positive person at
  the workplace. Employers may, however, choose to do so and should follow state
  and public health guidance for contact tracing.

                                                                        LOCKTON COMPANIES | 23
OSHA ETS: Reporting and recording requirements
• If an employer determines that a reported case of COVID-19 is work related, the employer
  must record that information on the OSHA Forms 300, 300A, and 301, or equivalent.
• When evaluating whether a fatality or in-patient hospitalization is the result of a work-related
  case of COVID-19, employers must follow the criteria in OSHA’s recordkeeping regulation for
  determining work-relatedness. See this OSHA Fact Sheet for more details.
  − An employer must make a report to OSHA within 24 hours of learning that (1) an employee
    has been in-patient hospitalized due to a confirmed case of COVID-19, and (2) the reason
    for the hospitalization was the result of a work-related exposure to the illness.
  − An employer must make a report to OSHA within 8 hours of learning both (1) that an
    employee has died from a confirmed case of COVID-19, and (2) that the cause of death was
    the result of a work-related exposure to COVID-19.
• Employers have three options to report work-related fatalities and in-patient hospitalizations
  to OSHA:
  − By phone to the nearest OSHA Area Office
  − By phone to the OSHA toll-free central number (1-800-321-OSHA)
  − By electronic submission at www.osha.gov

                                                                                    LOCKTON COMPANIES | 24
OSHA ETS – Recordkeeping
What records must a covered employer maintain?
• Roster: Identify each employee and record the employee’s vaccination status whether fully vaccinated, partially
  vaccinated, not fully vaccinated because of a medical or religious accommodation, not fully vaccinated because they have
  not provided acceptable proof of their vaccination status or unvaccinated.
• Proof of vaccination: Maintain copies (digital is compliant; should be readily accessible); keep a list of the aggregate
  number of fully vaccinated employees at the workplace along with the total number of employees.
• Test results: Maintain records of each test result provided by each employee.

How should the records be treated?
• These are confidential medical records subject to retention for the duration of the ETS (not OSHA’s 30-year record
  retention requirement).
• Comply with any applicable state law.

When is disclosure of records required?
• The roster must be available for inspection by OSHA within four business hours of a request.
• Employers must make an individual’s COVID-19 vaccine documentation available for examination and copying by the
  employee (or anyone with the employee’s written authorized consent).
• Employers must make available to an employee or the employee’s representative the aggregate number of fully
  vaccinated employees at a workplace along with the total number of employees at the workplace by the end of the next
  business day following the request.

                                                                                                          LOCKTON COMPANIES | 25
OSHA ETS: Required notices
• Employers must provide specified information to employees regarding COVID-19
  vaccine efficacy, safety and the benefits of being vaccinated in the written
  vaccine policy (CDC Key Things to Know About COVID-19 Vaccines)
• OSHA Workers' Rights under the COVID-19 Vaccination and Testing ETS
• OSHA Information for Employees on Penalties for False Statements and Records

                                                                    LOCKTON COMPANIES | 26
OSHA ETS – Enforcement
The ETS is silent — What is likely?
•   Inspections
•   Worker complaints

Penalties for employer
•   Standard penalty: $13,653
•   Willful violation: $136,532

Penalties for employee
•   Fines
•   Imprisonment

                                      LOCKTON COMPANIES | 27
Federal contractor vaccine mandate update
•   The deadline for federal contractors to be fully vaccinated is extended to Jan. 4, 2022.
•   A covered contractor does not need to re-collect employee vaccination cards if it
    previously obtained copies.
•   There is no deadline by which covered contractors must review accommodation
    requests, but unvaccinated employees should follow appropriate workplace safety
    protocols and the appropriate agency should be notified of the presence of
    unvaccinated employees at a federal work site.
•   Covered contractors may need to offer temporary accommodations to contractor
    employees who need to delay being vaccinated.
•   Corporate affiliates of a covered contractor may fall within the scope of the vaccine
    mandate depending on interrelated management and ownership.
•   Covered contractor employees who refuse to be vaccinated and do not seek an
    accommodation will not face automatic termination, but should be counseled and
    educated, and addressed through other disciplinary measures before being
    “removed” from the workplace.

                                                                           LOCKTON COMPANIES | 28
Testing and recordkeeping   Shealynn Buck, MD
                             SVP, Medical Director
considerations

KC: 82489
• Every 7 days is minimum
  testing frequency*
                                             ETS definition of
• Rapid antigen test method
  is more feasible than pooled
                                             COVID-19 test
  or lab send-out PCR test
  methods for most employers                 • Cleared, approved or authorized, including in an
• Antibody tests are not an                    Emergency Use Authorization (EUA), by the U.S.
  option                                       Food and Drug Administration (FDA) to detect
                                               current infection with the SARS-CoV-2 virus
• OSHA estimates 8-27% of
                                               (e.g., a viral test)
  employees may require
  testing over course of ETS                 • Administered in accordance with the authorized
  period                                       instructions
                                             • Not both self-administered and self-read
                                               unless observed by the employer or an
                                               authorized telehealth proctor
                                             • OSHA requires an independent confirmation of
                                               the test to ensure the integrity of the result

*Unvaccinated employees with documented
CV-19 infection within 90 days do not test
                                                                                  LOCKTON COMPANIES | 30
Test sourcing and administration
Options                               Pros                                                  Cons
Employer sources over-the-            •   Feasible for more structured workplaces           •   Sourcing and supply unpredictability
counter test kits and performs or     •   Better for workforces with testing access         •   Need trained and available staff to
proctors testing at workplace             limitations (rural, no reliable transportation)       perform/proctor
using employed staff or                                                                     •   Managing positive test results
contractor

Employer contracts with test          •   Feasible for more structured workplaces           •   Costly
vendor to source and perform          •   Employer doesn’t source or oversee testing        •   Limited vendor availability
testing at workplace or near-site     •   Better for workforces with testing access         •   Volume minimums
location                                  limitations (rural, no reliable transportation)

Employee purchases authorized         •   Feasible for more structured workplaces           •   Sourcing and supply unpredictability
kits from retailer and brings to      •   Employer shifts all sourcing responsibility to    •   Employee may purchase wrong kit
workplace for employer to                 employee                                          •   Need trained and available staff to proctor
proctor                                                                                     •   Managing positive test results

Employee purchases authorized         •   Employer shifts all sourcing responsibility to    •   Sourcing and supply unpredictability
kits from retailer that have              employee                                          •   Employee may purchase wrong kit
telehealth proctor option             •   Employee can perform at home and positive test    •   Limited vendors
                                          results occur outside of workplace                •   Requires app download, reliable Wifi, and video
                                                                                                conferencing capability

Employee schedules and obtains        •   Employer shifts all testing responsibility to     •   Employees who have testing access limitations
testing through retail pharmacy,          employee                                          •   Testing not covered by health plan unless special
retail clinic or drive-thru testing   •   Widely accessible except in rural areas               arrangements with plan administrator
site                                  •   Positive results immediately managed by
                                          healthcare pros

                                                                                                                              LOCKTON COMPANIES | 31
FDA EUA over-the-counter (OTC) rapid test kits
Non-healthcare employers can only purchase and perform OTC (retail) tests

                                            Telehealth             Purchase              Bulk order
                                          proctor option            option                option                     Other

 BinaxNOW COVID-19 Antigen Home Test             Yes                  Retail                   Yes

                                            Yes (purchased
                                                                                                              Voluntary recall of
 Ellume COVID-19 Home Test                separately through          Retail               Unknown
                                                                                                                  some lots
                                               AZOVA)

                                                                  Manufacturer
 iHealth COVID-19 Antigen Rapid Test             No                                            Yes
                                                                    Website

 InteliSwab COVID-19 Rapid Test                  No                   Retail                   Yes

 QuickVue At-Home OTC COVID-19 Test              No                   Retail                   Yes

                                                                    Retail
 BD Veritor At-Home COVID-19 Test                No                                        Unknown
                                                                 (Amazon only)

 DiaTrust COVID-19 Ag Home Test                         Currently appears to not be available for purchase in U.S.

 FlowFlex SARS-CoV-2 Antigen Rapid Test                 Currently appears to not be available for purchase in U.S.

                                                                                                             LOCKTON COMPANIES | 32
ER, urgent care and physician
                                                     offices are generally not feasible
Paying for testing                                   for screening tests due to higher
                                                     cost and wait times.
Employer pays
• Testing performed by healthcare provider, retail pharmacy or retail clinic for
  screening purposes is not standardly covered by health plan
• Employer purchases test kits through bulk ordering
• Employer contracts with on-site or near-site testing vendor
• Employer reimburses employee for purchased test kits or testing appointment
• Employer may be required to pay for testing per other laws, mandates or collective
  bargaining agreements
Employee pays
• May present issues with employee relations, attraction or retention
• Use caution if considering payroll deduction
• Screening tests are FSA/HSA eligible

                                                                          LOCKTON COMPANIES | 33
Recordkeeping solutions
Contract terms
• Many are 12+ months; ETS is six months (may be extended)
• Implementation 2-8 weeks
Cost
• Wide range of fees – heavy implementation fees
• Cost rising with demand
Usability
• HCM/HRIS systems may be less expensive but are less user friendly than third-party
  applications
  − HCM/HRIS systems are not ideal for less tech-minded positions
• Integration with HRIS, Badge Scan, SSO, API
• Push notifications and communication automation

                                                                      LOCKTON COMPANIES | 34
Recordkeeping solutions
Reporting
• OSHA reporting available within 4 hours of request
• Employee reporting available within 24 hours of request
• Role-based access
Vaccine tracking and verification
• Verification by vendor, HR or other designated staff
• Verify all records or random
• AI verification, integration with state vaccine registries
• Exemption documentation, management and approval

                                                               LOCKTON COMPANIES | 35
Edward Fensholt, J.D.
The CMS mandate        SVP, Director
                    Compliance Services

KC: 82489
The HIPAA issues with vaccination status
Not a HIPAA issue:
•   For the employer to ask employees for proof of vaccination status
•   For the employer to hire a vendor to ask employees for proof of vaccination status, or offer a portal for
    employee to upload vaccination status, or for the employer to collect vaccination status information
    from such a vendor
Is a HIPAA issue:
•   For an insured employer to ask for vaccination status from the insurer
    − If the insurer gives it, the employer has gone “hands on” its medical plan’s protected health
      information (PHI), triggering an obligation on the part of the employer to put HIPAA privacy and
      security policies in place for its medical plan
    − Potential violation to use the PHI, without authorization, for the employer’s purposes
•   For a self-insured employer to use the plan’s PHI to determine vaccination status for purposes of
    complying with an employer obligation like a vaccination mandate
    − Potential violation to use the PHI, without authorization, for the employer’s purposes
•   HIPAA’s exceptions to general rule barring unauthorized disclosure/use of PHI:
    − Averting a serious threat to public health and safety, and public health reporting and other public
      health activities … do these apply?                                                  LOCKTON COMPANIES   | 37
The CMS mandate
Centers for Medicare and Medicaid Services (CMS)
• Part of cabinet-level Department of Health and Human Services (HHS)
• CMS overseas the Medicare and Medicaid programs (in addition to the Children's
  Health Insurance Program (CHIP), and the state and federal ACA-created health
  insurance marketplaces)
• Has authority to regulate healthcare providers participating in these programs, and
  receiving federal healthcare dollars as a result
The vaccine mandate, in an “interim final rule,” applies to Medicare or Medicaid
certified providers and suppliers, essentially facilities that are subject to CMS health
and safety standards as a condition of participating in the federal programs
mentioned above … generally, Medicare and Medicaid-certified provider and
suppliers regulated under the Medicare health and safety standards known as
Conditions of Participation (CoPs), Conditions for Coverage (CfCs), or Requirements
for Participation
                                                                             LOCKTON COMPANIES | 38
The CMS mandate
The CMS vaccination mandate applies to:
•   Hospitals (critical access, acute care hospitals, psychiatric hospitals, hospital swing beds, long term care
    hospitals, children’s hospitals, transplant centers, cancer hospitals and rehabilitation hospitals/inpatient
    rehabilitation facilities)
•   Ambulatory Surgical Centers (ASCs)
•   Hospices
•   Psychiatric residential treatment facilities (PRTFs)
•   Programs of All-Inclusive Care for the Elderly (PACE)
•   Long Term Care (LTC) facilities, including Skilled Nursing Facilities (SNFs) and nursing homes
•   Intermediate Care Facilities for Individuals with Intellectual Disabilities (ICFs-IID)
•   Home Health Agencies (HHAs)
•   Comprehensive Outpatient Rehabilitation Facilities (CORFs)
•   Clinics, rehab agencies and public health agencies providing outpatient PT and speech-language
    pathology services
•   Community Mental Health Centers (CMHCs)
•   Home Infusion Therapy
•   Rural Health Clinics (RHCs)/Federally Qualified Health Centers (FQHCs)
•   End-Stage Renal Disease (ESRD) Facilities (i.e., dialysis)
                                                                                                   LOCKTON COMPANIES | 39
The CMS mandate
• The CMS vaccination mandate does not apply to:
  − Physician offices
  − Assisted living facilities, group homes and
    similar settings
  − Medicaid home and community-based services
  − Schools receiving Medicaid funding
  … but these entities might be subject to the OSHA emergency temporary standards.

• Similarly, the rules do not apply to:
  − Religious Nonmedical Health Care Institutions (RNHCIs)
  − Organ Procurement Organizations (OPOs)
  − Portable x-ray suppliers
  … but their staff might be indirectly subject to the CMS mandate if performing
  services for an entity subject to the rule, under a contract.
                                                                       LOCKTON COMPANIES | 40
The CMS mandate
Who must be vaccinated?
• Staff, regardless of clinical responsibilities or patient contact, including employees,
  licensed practitioners, students, trainees and volunteers
  − Includes staff providing patient care off-site
• Physicians with admitting privileges at the facility
• Individuals providing care or other services for the facility under contract or other
  arrangement (e.g., portable imaging vendors, but see the exception below)
Who gets a pass?
• Individuals providing services 100% remotely and have no direct physical contact
  with patients or other staff
  − E.g., telemedicine providers, payroll vendor, etc.

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The CMS mandate
When must staff and others be vaccinated?
• Subject to exceptions (for health and religious reasons):
  − By Dec. 5: First vaccine dose administered
  − By Jan. 4: Fully vaccinated (primary vaccination series)
  − New staff: Must have received, at a minimum, a single-dose COVID-19 vaccine,
    or the first dose of the primary vaccination series (for a multi-dose COVID-19
    vaccine) prior to providing any care, treatment or other services for the provider
    and/or its patient
• Temporary delays to these deadlines are allowed for individuals where appropriate,
  e.g., a recent COVID-19 diagnosis
  − There is no exception for individuals with COVID-19 antibodies
• Proof of booster shots is not required at this time

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The CMS mandate
• How does an individual prove vaccination?
  − CDC COVID-19 vaccination record card (or a
    legible photo of the card)
  − Documentation of vaccination from a
    healthcare provider or electronic health
    record
  − State immunization information system record
  − If vaccinated outside of the U.S., a reasonable equivalent of any of the
    previous examples
• The CMS rule preempts state vaccine rights laws
• A facility subject to the CMS rule and one or both of the OSHA rule and federal
  contractors rule should follow the CMS rule

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The CMS mandate
What if a facility subject to the
mandate fails to comply?
• CMS could quash the facility’s
  participation in the Medicare/Medicaid
  program; some facilities may be subject
  to monetary penalties (fines)

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Communications        Julie Gibson
                        EVP, Director
perspective      Marketing, Communications
                    and External Affairs
Employer considerations
• Make the decision that is right for your organization.
• Consider your client’s requirements — they have requirements that your teams will
  need to meet?
• Introduce the infrastructure to support your process; make it clear to communicate
  and simple to execute.
• This “why” is simple; every company is in the same position.
• Leave politics out of the workplace; focus on compliance and what is required
  based on your organization.
• Never say “never” … your people won’t forget.

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Communicate, even when you don’t know
Sample language:
• OSHA has recently issued the new rules related to the COVID vaccine mandate for
  employers
• We are preparing to comply with the recently passed OSHA ETS
• We have developed a plan that is right for our business
• What employees need to know:
  − Any changes to existing policy
  − The [process for providing proof of vaccine and/or weekly testing
  − If there will be consequences for not complying
• If you have questions, please reach out to [contact]

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Educate. Advocate.                                OSHA ETS Workplace
Communicate.                                      Communication:
                                                  Provide each employee with
                                                  information they can
                                                  understand about the
• Leverage your workplace influencers             requirements of the ETS and
                                                  the workplace policies and
• Employee advisory council                       procedures established to
• Workplace educational campaign                  implement the ETS; vaccine
                                                  efficacy, safety and the benefits
• Utilize a variety of channels to continue to    of being vaccinated by
  reach people                                    providing the Centers for
                                                  Disease Control and Prevention
• Prepare your managers; leader toolkits answer   (CDC) document Key Things to
  their questions first                           Know About COVID-19
                                                  Vaccines; protections against
• Coming together opportunity                     retaliation and discrimination;
• Find opportunities to create cultural moments   and laws that provide for
                                                  criminal penalties for knowingly
                                                  supplying false statements or
                                                  documentation.

                                                                  LOCKTON COMPANIES | 48
Appendix
An existing statute may require the employer to
pay for COVID-19 testing as follows:
States in which payment for a COVID-19 test is likely required under existing laws
addressing medical exams: Arkansas, California, Colorado, District of Columbia,
Hawaii, Illinois, Kentucky, Louisiana, Maine, Minnesota, Montana, New Hampshire,
North Dakota, Oklahoma, Pennsylvania, Rhode Island, South Dakota, Utah, Vermont,
Virginia, West Virginia, Wisconsin, Wyoming
States in which it is unclear if an employer must pay for COVID-19 testing: New York,
Oregon
States in which payment for a COVID-19 test performed “due to exposure to a
hazard” is likely required: Nevada, New Mexico, South Carolina, Tennessee
States in which payment for a COVID-19 test is likely required for certain employees
only: Maryland (essential workers), Michigan (only for return to work after
LOA/furlough), Washington (common rail carriers only)
States in which payment for a COVID-19 test is likely required when an employer-
designated physician conducts the test: Massachusetts, New Jersey
States with no existing statute potentially covering COVID-19 testing: Alabama,
Alaska, Arizona, Connecticut, Delaware, Florida, Georgia, Idaho, Indiana, Iowa, Kansas,
Mississippi, Missouri, Nebraska, North Carolina, Texas

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Existing COVID-19 related paid leave laws
(As of Nov. 10, 2021)

States and Localities with current   States and Localities with current
COVID-19 specific paid sick leave:   COVID-19 paid time off for vaccine
                                     requirements:
• Long Beach, CA
                                     • Los Angeles County, CA
• Los Angeles County, CA
                                     • Cook County, IL
• Oakland, CA
                                     • Massachusetts
• San Francisco, CA
                                     • Nevada
• Colorado
                                     • New York
• Massachusetts
                                     • Pittsburgh, PA
• New York
• Pittsburgh, PA
• Seattle, WA (Gig workers only)           NOTE: A state or local general state
                                           paid sick leave law would likely
                                           cover a COVID-19 related illness.

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Independence changes everything.

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