Column Editor’s note: This column presents a problematic case that poses a medical-ethical dilemma for patients, families, and healthcare professionals. As it is based on a real situation, some details have been changed in the effort to maintain confidentiality. In this case, the community pediatric society struggles with appropriate pediatric care in the face of considerable financial constraints.
Column editor: Ferdinand D. (Nick) Yates, Jr., MD, MA, Acting Consultant in Clinical Ethics, CBHD
Should a pediatrician use a less expensive and well-established vaccination product with adequate reimbursement rather than a newer, more expensive version with better bacterial protection that has a lower profit margin?
In 2001, Wyeth Vaccines (presently known as Pfizer) marketed a vaccine product known as Prevnar 7 (PCV7). The product enjoyed the full backing of the Center for Disease Control and Prevention (CDC), and several professional organizations recommended and endorsed its usage in the pediatric population. The product was used successfully for over a decade. As predicted, there was a definitive drop in the frequency of otitis media and, in addition, there was a diminished number of cases of blood stream infection and meningitis caused by the 7 (hence the name) subgroups of this particular bacterium.
In 2010, the vaccine producer was granted approval to market a new version—Prevnar 13 (PCV13)—that added substantial improvement in the vaccine protection rates, especially now that there would be protection for 13 subgroups instead of the initial 7 groups. As might be expected, the vaccination also came with a higher cost than PCV 7, and there was substantial hesitance, initially, on the part of local insurers to cover the vaccination—as PCV7 was still usable and well-established. Eventually, as it became apparent that the insurance carriers made PCV13 a “covered service”—meaning that the vaccine was allowed on the insurance company’s immunization formulary—the reimbursement margin to physicians providing the new vaccination would be substantially less that the margin for PCV7.
Members of the local pediatric community engaged in a heated discussion regarding this issue. Some felt that the parents of the child should make the decision as to which vaccination they preferred and pay the difference (out of pocket) for the difference in the vaccine cost. Others advocated a boycott of the new product, noting that the PCV7 was adequate and that the protection was sufficient. One of the pediatricians, a local expert in infectious diseases, stated very clearly that national medical organizations such as the Advisory Committee for Immune Practices (ACIP) and the American Academy of Pediatrics (AAP) had issued statements supporting the use of the newer product. The local medical ethicist—also a pediatrician—argued that children should not be “held as a hostage” in the deliberation with insurance companies and that the pediatrician had a prima facie duty to offer the best available care to the child.
How should the individual pediatrician respond? Should the local pediatric committee act in concert?
The pediatrician has both an ethical and a fiduciary responsibility to the pediatric patient, the family, and the community. In discharging these responsibilities, the pediatrician must be cognizant of the available resources, the financial aspect of practice, and the administration of appropriate medical care.
The cost of immunizations is not insignificant and often comprises approximately 25–30 % of a pediatric practices’ overhead. The up-to-date pediatric practice attempts to arrange cost-saving measures such as bulk ordering; sometimes by "piggy-back" ordering with other medical practices, and with the direct shipment from the manufacturer, it is possible to avoid the costs associated with the medical supplier. It is, therefore, not difficult to understand the pediatrician’s concerns regarding vaccine cost margins.
The protection of vulnerable children from infectious disease is an important part of the modern-day pediatric practice. Presently, vaccinations are a routine part of pediatric care, and the vaccination process typically begins shortly after birth, before mother and infant are discharged from the hospital. Whereas some parents refuse vaccinations for their children, it is important for the pediatrician to engage in dialogue with these families, and they should not be discharged from the physician's practice because of refusal to vaccinate. Nonetheless, the physician should develop a policy regarding the outbreak of community-wide infectious disease, and this policy should be presented to the patient’s parents at the time of the patient’s initial visit. In this type of situation, parental prerogative should likely be suspended, and the pediatric patient should be vaccinated in the attempt to protect the child as well as the community.
The penultimate duty of the pediatrician is to provide proper health care for the pediatric patient and the community. The pediatrician, a health care professional, has a specialized body of knowledge and experience that appropriately informs him in the process of offering health care to the patient and family. Whereas there are practice-specific variations within the pediatric community, much of the routine health care recommendations and provisions should be virtually identical throughout the community. Much of the reason for this commonality is that a majority of the physicians in our community trained at the same location and that many of us have trained each other in a type of “mentor” model. In addition, a significant majority of the local pediatricians are Fellows of the American Academy of Pediatrics—an organization that suggests a certain standard of care in various healthcare scenarios and in particular the recommendation of routine vaccination of children.
Some of the recommendations (specifically for vaccinations) are routinely informed by national organizations with backing from the federal government. Often, for example, the ACIP is in routine agreement with the CDC, as the safety and efficacy of the vaccines is assessed (based on scrutinized study data presented by the drug company) and recommendations for vaccine use are proposed (based on this information). Rather routinely, medical professional organizations such as the AAP and the American Medical Association (AMA) adopt these recommendations in a timely fashion. So, if the practicing doctor volitionally delays adoption of these endorsements for a prolonged time or for inappropriate reasons, he may be at risk of tort action if a patient under his care acquires a vaccine-preventable disease.
In providing proper health care for the child in the community, the pediatrician voluntarily aligns with various health care insurance organizations and, in so doing, agrees to abide by the endorsed recommendations from professional organizations. This is a fiduciary opportunity in which the pediatrician agrees to provide proper and standard care within the community. With the introduction of a new vaccine product, the pediatrician has the professional responsibility of considering the appropriateness of this new option. The implementation of the new product must be considered in light of its effectiveness, usefulness, and appropriateness within the routine medical care offered by the pediatric practice.
Cost or professional preference may be germane decision parameters when medical products have comparable effectiveness, indications, and specific practice applications. Financial discriminations are inappropriate and ethically bankrupt where there is a clear medical benefit and indication for the use of the newly-available product. The professional pediatrician must not allow personal gain and profit to influence his decision-making regarding the fiduciary care and responsibility of his patients. In providing high-quality professional medical care for the pediatric patient, the pediatrician has an obligation and responsibility to provide the best appropriate care for the medical situation, keeping in mind the best interest of the patient, the family, and the community.
Many local practices (including the author’s) depleted the stock of PCV7 and immediately replaced it with PCV13. It was not long before all of the pediatric offices within the community fully recognized the appropriateness of the new vaccination and were using the newer product.
Paul S, Donn S. “Legal Right to Refuse”. AAP News, February 2011, p. 16.
Yates F. “Should Children be Routinely Immunized?”. www.cbhd.org/resources/healthcare/yates_2004-04-16_print.htm
Editor’s Note: This case study originally appeared in Ethics & Medicine: An International Journal of Bioethics 28, no. 1 (2012) and is used by permission.
