HHS promises compensation for vaccine costs
Despite legal protections included in the Homeland Security Act, hospitals still face workers’ compensation liability and possibly other legal exposure from the smallpox vaccination of health care workers, according to lawyers who specialize in the health care field. The uncertainty of the legal and financial risk may prompt some hospitals to limit or even decline vaccination of their employees.
In a telebriefing after President Bush formally announced the smallpox vaccination program, Tommy Thompson, the secretary of the Depart-ment of Health and Human Services, reassured hospitals that they may receive funding and possibly even additional legislation to address their concerns about the costs and liability.
"We anticipate when Congress passes the next appropriate bills for the Department of Health and Human Services, there will be included in there, almost $1.5 billion, of which about $535 million will be for hospitals, and we will be working with the states in the implementation of their plans . . . to be able to take into consideration any further costs that may result as a result of this vaccination program," he said. "And we are also looking at the potential of introducing some further legislation."
The protections of the Homeland Security Act were scheduled to become effective Jan. 24 and are triggered by a declaration from Thompson that vaccination is a necessary countermeasure against a smallpox bioterrorism threat. He said workers will be covered by workers’ compensation plans. Funding for hospitals could offset some of the costs related to those claims.
Thompson also said doctors, hospitals, "and other licensed individuals" would be considered "agents of the federal government," and therefore, covered by the Homeland Security Act immunity protections. "I want to point out here that we will be interpreting the statute very generously to cover as many of these people as possible."
However, previously, a fact sheet issued by the Centers for Disease Control and Prevention (CDC) in Atlanta indicated that hospitals might not be covered if the vaccines were administered by public health officials in another location.
Unless Congress further clarifies the liability issue, hospitals may be reluctant to participate — particularly if their employees would receive the vaccine from a public health clinic, says Edward Richards, JD, MPH, director of the program in law, science, and public health at the Louisiana State University School of Law in Baton Rouge. "A hospital would have to be pretty gutsy to participate in this program at all if that [liability] is not clear," Richards says.
Shortly after President Bush announced the administration’s smallpox vaccination plan, the legal implications remained unclear. In interviews with Hospital Employee Health, several lawyers who specialize in workers’ compensation and health care law offered this assessment:
- Workers’ compensation
likely will cover employees who are injured by the vaccinia vaccine.
"They’re on the line on workers’ compensation," says Jon Gelman, an attorney based in Wayne, NJ, who specializes in work-related injuries. Gelman is the national media advisor on workers’ compensation for the West Group legal publishers.
"There are no insulation factors against paying for workers’ compensation, and there has been no removal of liability by Congress," he says. "So workers’ compensation is going to be the primary source of benefits should anybody have an adverse response to any of the vaccine programs, including smallpox."
For the few who have severe reactions, which could include progressive vaccinia, encephalitis and death, workers’ compensation medical benefits would include all future medical treatment, accommodations, and dependency benefits, Gelman notes.
The voluntary nature of the vaccinations apparently will not affect the workers’ compensation status. Workers may suffer from lost work time due to milder reactions, without workers’ compensation benefits.
Workers’ compensation programs may not cover employees with milder reactions, and those employees may fail to get any compensation for their sick time, says Dominick Tuminaro, JD, a New York City-based attorney who specializes in workers’ compensation. "Typically, most workers’ comp systems have a waiting period. If you’re out for seven days or less, you’re not eligible for compensation," he says.
Many employees may simply use their own medical insurance, and they may fail to establish the causal link necessary to trigger workers’ compensation, he says. Hospitals should ensure that workers don’t need to use their own sick time for symptoms related to the vaccine, he says.
"The appropriate thing would be for institutions to recognize that you’re asking people to volunteer," he says. "If they do have an adverse reaction, you ought to hold them harmless."
In fact, some hospitals are taking that approach. For example, Baystate Health System in Spring-field, MA, will cover employees for any vaccine-related symptoms, so they will not have to use their sick time. The three-hospital health system also will cover medical costs for employee’s household contacts who are inadvertently inoculated, says James Garb, MD, director of occupational health and safety.
"There are certainly enough barriers to vaccination that I didn’t want to create any unnecessarily," he says. "At least they won’t have the financial concerns to worry about."
- No clear mechanism
of compensation has been established for those who suffer from secondary transmission
of vaccinia.
Although the Homeland Security Act protects those producing and administering the vaccine from lawsuits, it does not spell out any mechanism for compensation for those who are injured by the vaccine. The compensation issue will need to be addressed, Thompson said in a briefing.
But until it is, uncertainty prevails. Suing the federal government over vaccine effects would be very difficult, Richards says. "This is not a claim like the vaccine compensation fund. You have to prove negligence in order to collect. That Federal Tort Claims Act provides very significant defenses."
But if victims have no clear path to compensation, a judge may scrutinize the Homeland Security Act. "They’re going to be looking for reasons to narrow the immunity protections of the act," he says.
The act states, "[A] covered person [is] a manufacturer or distributor of such countermeasure, a health care entity under whose auspices such countermeasure was administered, a qualified person who administered such countermeasure, or an official, agent, or employee of a person" in the other groups.
- Extra precautions
taken in screening or in limiting employee contact with the most vulnerable
patients could reduce liability.
Hospitals face yet another dilemma. Careful screening for contraindications will greatly reduce the danger of serious adverse effects. But when more restrictions are placed on who can receive the vaccine, the hospitals may have difficulty finding enough eligible volunteers. Richards advises taking a conservative approach, even if it means vaccinating fewer workers.
The risk of nosocomial transmission of vaccine to vulnerable, immunosuppressed patients also worries hospitals. The CDC does not recommend furlough of employees and says semipermeable dressings, good hand hygiene, and monitoring of the injection site can greatly reduce the risk.
Yet the Food and Drug Administration- (FDA) approved label for Dryvax, the current stock of vaccinia vaccine, states: "Recently vaccinated health care workers should avoid contact with patients, particularly those with immunodeficiencies, until the scab has separated from the skin at the vaccination site.
"However, if continued contact with patients is essential and unavoidable, they may continue to have contact with patients, including those with immunodeficiencies, as long as the vaccination site is well covered and good hand-washing technique is maintained by the vaccinee."
"This label sets a pretty strong legal standard," Richards says. "The FDA, through their official label, says you do have to keep [vaccinated health care workers] away from patients. If the hospital doesn’t have Homeland Security Act immunity and they get sued, the plaintiffs’ lawyer exhibit one is going to be this label. Could no one else take care of these patients? Was this essential and unavoidable?’"
Despite legal protections included in the Homeland Security Act, hospitals still face workers compensation liability and possibly other legal exposure from the smallpox vaccination of health care workers, according to lawyers who specialize in the health care field.
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