COVID-19 Vaccine & Medical Liability Q&A

COVID-19 VACCINATION & MEDICAL LIABILITY TOPICS


PROFESSIONAL LIABILITY COVERAGE CONCERNS

ProAssurance cannot provide a coverage opinion or confirm coverage as to hypothetical claims. Coverage opinions are provided only after analyzing the specific allegations of an actual claim together with the applicable policy. The information here is general in nature and should not be interpreted to mean any given claim or actions by an insured will be covered by our policy. Rather, we will adhere strictly to the provisions of our policy, which is the only statement of our coverage obligations.

Am I covered to administer a vaccine with only Food and Drug Administration (FDA) emergency use authorization (EUA) approval, but not full FDA approval?

The ProAssurance healthcare professional liability policy covers insured professionals who:

  • Act within the scope of their employment
  • Are engaged in the performance of professional services to a patient
  • Hold any required license to perform the service

There is no coverage difference or policy exclusion based on the FDA EUA approval status. 

Are my employees and I covered for administering the vaccine at a location outside our normal practice setting such as in a senior care facility, a pop-up clinic, or drive thru clinic, etc.?

The ProAssurance health care professional liability insurance policy generally applies to professional incidents arising out of professional services or peer review services rendered anywhere in the world, provided that any resulting claim or suit is prosecuted within the United States of America, its possessions or territories, unless your policy contains an endorsement with a location restriction.

What are the insurance implications of retired physicians administering the vaccine on temporary return to practice or volunteer basis?

Physicians returning to practice from retirement on a temporary basis or as a volunteer to administer the COVID-19 vaccine will not jeopardize extended reporting endorsements issued by ProAssurance without payment of additional premium.

Volunteers may have professional liability coverage under the insurance policy of the facility organizing the vaccination program. We recommend you confirm coverage with the facility in advance of beginning work. If you are unsure or have additional questions, your agent or ProAssurance service representative can advise you or help secure supplemental coverage if needed.

For physicians seeking coverage for a more than temporary return to practice activities, please contact your agent or ProAssurance service representative for assistance in submitting an application to the Company. We will endeavor to provide an underwriting decision for completed applications within two business days.

RISK MANAGEMENT CONCERNS

How should one document vaccine administration?

We encourage physicians to document each order for a vaccine in the medical record. If the order is verbal, we suggest the physician co-sign the order. Without this documentation, an employee who administers a vaccine may appear to be functioning outside their scope of practice.

Additional information to document includes:

  • Allergies, especially to vaccines and/or components
  • Discussion of the risks, benefits, and alternatives
  • Date
  • Name of vaccine administered
  • Dosage
  • Injection site
  • Manufacturer and lot number
  • Signature or initials of person administering the injection
  • Known side effects and/or complications
  • Instructions provided to the patient
  • Patient's receipt of manufacturer's Vaccination Information Sheet

How should one monitor a patient after vaccine administration?

Refer to the vaccine manufacturer's recommendations for patient observation following injection. Be prepared to manage allergic reactions in accordance with your emergency response plan.

How should I respond to a patient reporting significant post-vaccine side effects?

Advise the patient to call 911 and immediately seek emergency care if they are experiencing life threatening symptoms.

If symptoms are not life threatening, obtain and review the “Fact Sheet for Healthcare Providers Administering Vaccine” for each vaccine manufacturer, paying special attention to Adverse Reactions and Information to Provide Vaccine Recipients/Caregivers.

Obtain chief complaint from the patient, symptoms, the brand of vaccine received, the date and time, and administration location. Triage care based on the type and severity of symptoms.

Document the communication, including symptoms and advised treatment, in the medical record. Adverse reactions must be reported to the Vaccine Adverse Event Reporting System.

How should one monitor second-dose compliance?

  • Document the patient was scheduled for and informed of the necessity to return for the second dose.
  • Provide a vaccination card to the recipient or their caregiver with the date when the recipient needs to return for the second dose.
  • Establish a tracking system to monitor patient compliance for the second dose.
  • Examples of immunization reminder-recall systems would be a centralized log followed by patient calls or patient portal reminders. 

 

OTHER CONCERNS

Is our practice eligible to administer the vaccine?

Physicians are eligible providers of the vaccine. Access to the vaccine is managed by state and local health jurisdictions, and vaccine administration will be based on priority.

If you elect to enroll in the federal vaccine administration program as implemented in your state, ensure you are able to manage vaccine storage and maintenance, staff education related to vaccine administration, and all other vaccine administration requirements.

What should be included in staff training, competency, and documentation regarding injection techniques?

The CDC prepared a clearinghouse of staff education resources. Consider which resources best meet your staff's educational needs.

Evaluate staff competency in injection techniques and document employee competency in a skills checklist to be included in the employee's personnel file. 

Can a practice require employees to take the vaccine?

Refer to governmental guidance on vaccine requirements for employees.

Are there specific reimbursement criteria related to vaccine administration?

Federal guidance exists to aid practices in coding for vaccination program implementation.

 

LINKS TO CENTERS FOR DISEASE CONTROL AND PREVENTION (CDC) AND STATE GUIDELINES

The CDC’s Healthcare Professionals: Preparing for COVID-19 Vaccination has up-to-date training and educational materials including preparation, handling and storage guidance, and patient communications. 

The CDC’s COVID-19 Vaccination Program Operational Guidance posts the most up-to-date playbook for jurisdictional operations and downloadable plans for every state and U.S. territory.

The Kaiser Family Foundation’s How are States Prioritizing Who Will Get the COVID-19 Vaccine First? page includes links to prioritization guidelines for all states.

 

OTHER QUESTIONS?

Didn't find the COVID-19 vaccine information you were seeking on this page? 

Let us know what we missed or need to clarify.

 

Page last updated January 7, 2021..

Looking for general COVID-19 information?

Visit our COVID-19 Information Center for ProAssurance service updates and answers to your medical professional liability concerns.

Guidelines for Practicing During a Pandemic

Here is a frequently updated guide to returning to full-time practice as the country reopens. Visit the Guidelines for Practicing During a Pandemic page.

Contact Us

Call ProAssurance toll-free 800-282-6242.

Contact our Risk Resource Advisor line: 844-223-9648 and select option 1, or email RiskAdvisor@ProAssurance.com.

To report a claim, call Claims: 877-778-2524 or email ClaimsIntake@ProAssurance.com.