Is the U.S. healthcare industry prepared to shoulder the massive responsibility of administering an estimated 300 million COVID-19 vaccinations?
Healthcare professionals will face challenges, according to experts at insurance broker Aon. Most of those giving the shots will have experience in administering vaccines, although some may not. They will have to follow strict guidelines from the manufacturers for storing and handling the medications. They will be relying upon Center for Disease Control (CDC) guidance and training, including on how to get patients to return for their second shots.
While there are government protections in place, healthcare professionals and institutions still face potential liability issues over the program even as they contend with how to simultaneously vaccinate their fellow frontline workers.
Aon has a dedicated healthcare practice that has been serving the healthcare industry for 35 years. Insurance Journal asked two experts– Neal Mills, chief medical officer at Aon, and Gigi Norris, co-leader of Aon’s infectious disease task force—for their take on the challenges to the healthcare industry posed by the COVID-19 vaccine program now underway.
Who will be giving the actual shots?
Mills: Doctors, nurses, physician assistants, nurse practitioners, pharmacists, pharmacy techs will be the predominant providers for vaccinations. In some instances dentists, optometrists and students of various health professions may also administer vaccines.
What type of training, licensing, authorization, etc. are required of those giving shots?
Mills: Licensure and authorized vaccine providers will depend on federal and state guidelines, which are still in development.
Do you anticipate these requirements being relaxed?
Mills: Expect temporary and/or emergency authorizations for relaxed eligibility criteria for vaccine providers for many states and territories in the United States. 300 million Americans still need to be vaccinated.
Will keeping tabs on patients who receive the first shot and must be contacted for the second shot be a challenge?
Mills: Tracking who has not received the second dose will be a monumental challenge for the healthcare sector. Look for elaborate systems to emerge with some built in redundancies to ensure the 2nd dose is administered, including reminder cards dispensed concurrently with vaccine, digital prompts, and state and federal registries.
CDC has provided requirements and expectations of vaccination administrators and vaccination program providers on pages 35-41 of CDC COVID-19 Vaccination Interim Playbook (https://www.cdc.gov/vaccines/imz-managers/downloads/COVID-19-Vaccination-Program-Interim_Playbook.pdf) as respects documentation, reporting, second-dose reminders and requirements for immunization information systems, and those requirements and expectations may be further adapted at the jurisdiction level.
It appears the vaccines are being shipped to CVS stores and Walgreens as well as hospitals, clinics and other providers. Are they all equipped and trained to handle, store and administer vaccines?
Norris: Vaccine will be administered by licensed healthcare professionals. Enrolled COVID-19 vaccination providers must be credentialed/licensed in the jurisdiction where vaccination takes place, and sign and agree to the conditions in the CDC COVID-19 Vaccination Program Provider Agreement. (See pg 21-24 in the CDC COVID-19 Vaccination Interim Playbook for requirements and expectations: https://www.cdc.gov/vaccines/imz-managers/downloads/COVID-19-Vaccination-Program-Interim_Playbook.pdf, as well as requirements and expectations at the state and local level where CDC guidance has been adapted to local situation – see https://www.cdc.gov/vaccines/covid-19/covid19-vaccination-guidance.html for links to State Playbook Executive Summaries as well as https://www.kff.org/policy-watch/how-are-states-prioritizing-who-will-get-the-covid-19-vaccine-first/ for links to updated details for individual states.)
Norris: Training of COVID-19 vaccination providers is vital to ensure the success of the COVID-19 Vaccination Program. CDC will have many educational resources available for use but immunization programs may develop or use other materials in conjunction with CDC materials.
Jurisdictions should determine the most efficient methods for training delivery and tracking. Jurisdictions will not be required to provide training for federal entities and commercial partners receiving direct vaccine allocations from CDC. (See pg. 22 https://www.cdc.gov/vaccines/imz-managers/downloads/COVID-19-Vaccination-Program-Interim_Playbook.pdf).
CDC has compiled a number of clinical training and resources for healthcare providers who will be working with COVID-19 vaccine. https://www.cdc.gov/vaccines/covid-19/downloads/COVID-19-Clinical-Training-and-Resources-for-HCPs.pdf. With respect to CVS and Walgreens for the long-term care vaccination program, please see further CDC guidance at https://www.cdc.gov/vaccines/covid-19/long-term-care/pharmacy-partnerships.html.
As we understand from our health care clients, who are currently in the process of receiving and administering vaccine, their vaccination programs will be based on plans previously developed for prior public health events, such as H1N1 and Ebola, as well as their own, internal flu vaccination campaigns.
Are there particular requirements for the storing, handling and administering these vaccines compared to past vaccines?
Mills: Yes. Each vaccine candidate has specific storage and handling requirements. We expect this information will change, depending on which vaccine(s) the Food and Drug Administration authorizes or approves.
What must healthcare professionals be aware of and do upon receipt of the vaccines?
- Inspect and replenish the dry ice pellets within 24 hours of receiving the shipment
- Wear special gloves to protect against injury when you handle the dry ice pellets during re-icing (see the Laboratory Safety: Cryogens and Dry Ice guide (PDF) from the Occupational Safety and Health Administration for more information)
- Re-ice every five days and limit openings to two openings per day to maintain ultra-low temperatures
- Re-ice up to three times.
- After 15 days in the thermal shipper, you can store the vaccine for an additional five days in a refrigerator at 2°C to 8° C.
There has been limited guidance on additional security requirements hospitals and clinicians need to undertake.
Do typical insurance policies anticipate them handling such a program?
Norris: The Public Health Emergency Declarations in many states and local jurisdictions, as well as the Federal PREP Act, may provide some level of legal immunity to healthcare providers engaged in the administration of COVID-19 countermeasures. Healthcare professionals and healthcare entities also typically purchase healthcare professional liability policies that are designed to provide bodily injury/property damage coverage in the event of patient injury, including such injury related to vaccine administration.
Also, the Federal Government has recently created a corollary program, the Countermeasures Injury Compensation Program (CICP), in order to provide compensation for individuals who are injured through the COVID-19 vaccine administration process. CICP is intended as a payor of last resort and can only reimburse or pay for medical services or items, or lost employment income that are not covered by other third-party payers, such as health insurance, Veterans Affairs benefits or Workers’ Compensation.
Drug makers are shielded from liability over the vaccines with any injury claims going to a taxpayer-funded federal program. However, are there areas where the cause of injuries could be uncertain or due to error by the healthcare provider?
Norris: Yes. Injuries or adverse events may be sustained if a health care provider administers the vaccine incorrectly. For example, damage to the muscles, nerves and tendons in the upper arm and shoulder can during the administration of any vaccine administered in that area. This typically occurs when the person administering the vaccine injects the patient too high up on the shoulder, or too deeply into the deltoid muscle. For individuals diagnosed with injuries resulting from routine vaccinations, compensation may be available through the National Vaccine Injury Compensation Program (VICP). The Federal Government has recently created a corollary program, the Countermeasures Injury Compensation Program (CICP) as discussed above.
How are healthcare employers approaching having their own employees take the vaccine? Are they requiring it of most employees?
Mills: Most employers are not anticipated to require the administration of any vaccine where long term research has established neither efficacy nor safety. Millions of doses need to be administered before this action would be considered by employers. The vaccine represents an opportunity to protect the health of entire employee populations. Most employers will lead in their communities by education of what we do know about the vaccine, through emerging campaigns, pledges, and ensuring this is covered at no cost to the employee or their families. This critical mission is being undertaken now.