Despite advantages, financial issues pose challenges for combination vaccines

Multiple-antigen vaccine formulations may offer busy pediatricians a way to improve patient vaccine experiences, as well as a solution to meet the demands of a continually expanding childhood immunization schedule, but do little to quell complaints from some practitioners who say they are going broke promoting public health.

“A lot of practices around the United States are losing money on vaccines,” Norman “Chip” Harbaugh, MD, fellow of the American Academy of Pediatrics and a practicing pediatrician at the Children’s Medical Group in Atlanta, told Infectious Diseases in Children. “These practices give the vaccines, but they have to spend time counseling patients, nursing time and storage time. As they do that, they are going in the hole because they don’t get reimbursed for their costs.”

Although Harbaugh has chosen to use combination vaccines in his practice, he expressed concerns that they may be among the first to get cut when practices experience financial difficulties. He said that physicians can lose as much as $30 in administration fees each time a combination is used instead of constituent vaccines because insurers provide compensation based on the number of injections given.

More than half of a nationally representative sample of pediatricians who responded to a survey earlier this year indicated that they did not receive adequate reimbursement for vaccine costs and administration. Furthermore, 20% of respondents participating in the same study said that reimbursement issues influenced decisions not to use combination vaccines.

Similarly, in a separate University of Michigan survey that involved U.S. pediatricians and family physicians, 49% of 784 respondents indicated that they had delayed purchasing vaccines for financial reasons, and 53% said they had experienced decreases in profit margins during the three years before the study. Despite this, only 11% of respondents said that they had actually considered ceasing vaccine administration all together.

“Hard decisions are being made out there, but if people do the right thing and chose combination vaccines from a quality stand point, they will win in the end,” Harbaugh said.

Paul Offit, MD, who is an Infectious Diseases in Children editorial board member, acknowledged potential financial disincentives for providers, as well as the large amount of time and money needed to develop combinations, but called them “a tremendous value.”

“The advantage is fewer shots in a very crowded schedule,” Offit, who has co-invented a rotavirus vaccine for Merck, said.

Stan Block, MD, also an Infectious Diseases in Children editorial board member who practices pediatrics in rural Bardstown, Ky., called the decision to use combination vaccines a question of personal philosophy.

“One has to wonder if the reason some are not giving combination vaccines is because of the revenue issue. It’s a real ethical dilemma for some practitioners, and it’s concerning and unfair,” he said. “Is making enough money by increasing the number of vaccine sticks more essential, or should we be kinder to our smallest patrons? In the end, offices have to stay financially solvent.”

Combination vaccine benefits

In June, the Advisory Committee on Immunization Practices reinstated its preference for the use of combination vaccines in lieu of single-antigen vaccines. The committee agreed that combination formulations enable clinicians to administer the necessary doses in the childhood immunization schedule using fewer injections, with similar safety and efficacy profiles as the constituent vaccines that make them up.

This stance is one that Block said most pediatricians welcome.

With 14 vaccines required in the current childhood immunization schedule, children can receive as many as 26 inoculations in the first few years of life. Fewer shots equal less pain, happier children and more satisfied parents, according to Block, who also contends that combination vaccines help reduce clerical and nursing errors in the pediatric office.

“These make a huge difference in the number of vaccines we have to store. If you’re giving 80 to 100 shots a month, you don’t have to worry as much about confusing vaccine storage or duplicating shots,” he said.

Other studies show that the benefits of combination vaccines may be wider in scope than initially believed, resulting in improved vaccine coverage and vaccination timeliness.

A retrospective analysis of administrative claims data from the Georgia Division of Public Health Medicaid program involving 18,821 infants compared coverage rates among children who received either combinations of Haemophilus b conjugate vaccine, hepatitis b vaccine, recombinant (Comvax, Merck) or diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed, hepatitis b vaccine, recombinant, poliovirus vaccine inactivated (Pediarix, GlaxoSmithKline) with children who did not receive either combination.

“Receipt of at least one dose of a combination vaccine was independently associated with increased coverage for each of these vaccines and vaccine series when controlling for gender, birth quarter, race, rural versus urban residence and historical provider immunization quality,” Marshall and colleagues wrote in the 2007 study that was published in the Pediatric Infectious Disease Journal.

Results from a 2006 German study showed up-to-date vaccination status increased for Haemophilus influenzae type B, polio and hepatitis B virus as multiple-antigen combinations began to replace monovalent vaccines. Median ages for vaccination improved when children received a combination vaccine containing Hib, polio, HBV and DTaP with children receiving the first dose of Hib 0.5 months earlier, 0.4 months earlier for polio and 0.9 months earlier for HBV. Additionally, complete dosages were received 2.2 months earlier for Hib, 3.2 months earlier for polio and 1.4 months earlier for HBV when children received a combination.

Safety concerns

Despite data that indicate a generally safe profile for combination vaccines, many parents have asked their pediatricians about separately administered vaccines after the publication two years ago of a book by Robert Sears, The Vaccine Book: Making the Right Decision for Your Child.

In the book, Sears has a table with suggestions for parents about how they can withhold or space out vaccines. He specifically mentions the controversy over the combination measles-mumps-rubella vaccine and its purported link to autism. He writes in the book, “Some doctors and researchers who suspect the MMR vaccine may play a role in autism also feel it is safer to give the three injections separately, spaced out one year apart. I can’t find enough research to determine if this precaution is justified, but in theory it does make sense.” He recommends that the vaccine be administered as single-antigen vaccinations.

But delaying or separating vaccines to make a parent feel better is not a good enough reason, according to Offit. Every time a vaccine is added to the childhood immunization schedule, the FDA requires studies to show that the new vaccine does not interfere with the immune response of existing vaccines.

“The fact is that the current schedule is very safe and effective. It prevents children from getting diseases,” Offit said. “When you delay vaccines, separate vaccines, withhold or space out vaccines, you only increase the period of time that vulnerable children are susceptible to diseases that can kill them.”

Harbaugh said these unfounded but widely publicized claims linking combined vaccines and autism have increased the amount of anxiety parents experience when they bring their child to their physician’s office and lengthen the amount of time physicians spend counseling parents about vaccine decisions. He estimates that he can spend 10 to 30 minutes counseling parents about vaccine risks and benefits.

The single-antigen discussion took center stage at the June ACIP meeting, both because of Sears’ recommendations and recent data linking increased risk for febrile seizures with the combined measles-mumps rubella-varicella (MMRV, ProQuad, Merck) vaccine.

In their recommendation, ACIP members gave health care providers the option of administering either MMRV vaccine or separate MMR and varicella vaccines to children aged 12 months to 3 years for the first dose in the measles, mumps, rubella and varicella immunization schedule after discussing the benefits and risks of both options with parents or caregivers. Although the working group concluded that the risk for febrile seizure was about two-fold greater among children aged 12 to 23 months during the one to two weeks after vaccination with the first dose of MMRV compared with children who received MMR vaccine plus varicella vaccine — they noted that children who experienced febrile seizures generally had an excellent prognosis.

“The overall incidence of febrile seizures between the two groups was no different within the entire month following vaccination,” Block noted. “I feel it is much ado about nothing.”

However, in discussing the issue with the committee before its decision, Mona Marin, MD, a member of the CDC’s division of viral diseases said the neutral language, “allows physicians and parents to make a decision that best suits a child’s individual situation.”

Offit suggests that the care with which the CDC has handled febrile seizures and MMRV is a testament to the quality of clinical trials and safety monitoring today. He said the abundance of historical data on MMR plus varicella combined with collaborative programs such as the Vaccine Adverse Event Reporting System and the Vaccine Safety Datalink are what enabled physicians to pick up differences between the separately administered and combined doses of MMRV in the first place.

“Four million children are born every year in this country that get vaccines that protect against 14 different diseases. If you look at the record of the safety of vaccines, it is better than anything else we put in our body,” Offit said. “It’s remarkable. And yet, we rarely give vaccines that level of credit, even though they deserve it.”

Addressing vaccine hesitancy

Most parents are overwhelmingly accepting about the prospect of protecting their children with fewer injections, according to Block, who said that only a very small percentage of parents worry that their child’s immune system is too young and vulnerable to handle multiple vaccines administered at once.

He calls these worries “nonsensical.”

Explaining the real risk vs. the theoretical risk may be the best approach in discussing vaccine safety with parents, Block said.

“The risk of death from car wrecks that may occur when going to the office for separate shots is going to far exceed any possible theoretical risk of death from a vaccine,” he said. “Separating vaccine components will definitely increase their costs and also increase their child’s risk for death substantially. When you delay vaccinations two weeks to eight weeks, to four months, this can be significant when you’re talking about severe childhood diseases like pertussis, Hib and measles. Any delay in coverage for those three particularly horrendous diseases are not medically or legally justifiable to me.”

Although he understands parents’ concerns, Offit maintains that physicians must rely on science and reason. He suggests swabbing the nose of a child and letting parents look at the bacteria under the microscope.

“The immune burden from vaccines is trivial,” Offit said. “A single cold virus like a rhinovirus, adenovirus or influenza virus reproduces itself hundreds of thousands of times and produces a much more intense immune response than all of the vaccines combined.”

Understanding the economics

The additional time spent discussing risks and benefits with parents adds up, along with other common vaccine-related cost issues, leaving many pediatricians feeling that they are shouldering the brunt of what they feel is society’s burden.

The presence of more combination vaccines in the childhood schedule has exacerbated financial worries as many insurance companies have not adjusted reimbursement rates to account for these more expensive vaccines.

Harbaugh estimates that vaccine-related costs make up about 20% to 25% of his practice’s expenses and said that they can cost pediatricians $100,000 to $150,000 annually when taking the following factors into consideration:

• Employing a nurse to decide how much vaccine to buy and stock.
• The cost of refrigerators to store the vaccines and backup generators and alarm systems to keep those machine’s running if the power goes out.
• Vaccine insurance to cover wastage that occurs if a vaccine is accidentally dropped.
• Out-of-pocket expenses that occur when a vaccine is administered to an uninsured patient unknowingly.

Gary L. Freed, MD, MPH, director of the Child Health Evaluation and Research Unit and director in the division of general pediatrics at the University of Michigan Medical School, said figures concerning the proportion of a practice’s budget that goes toward vaccine financing are anecdotal because no national data are available.

“Our studies indicate that likely only a few practices are actually losing money on vaccines purchased,” Freed said. Instead, he contends that practices’ experiencing problems have become more vocal about it.

The AAP puts best practice vaccine reimbursement rates at 17% to 28% above the cost of the vaccine itself to ensure that health care providers break even; however, data from a study that Freed was involved with show that the price that practices pay for vaccines and the net yield they make from them vary widely and depend upon numerous criteria.

Freed and colleagues surveyed 76 private practices in five states and found the following:

• Family practices and pediatricians paid as little as $4 and as much as $30 for the same vaccines.
• Reimbursement for a single vaccine administered to privately insured patients ranged from $8 to $80.
• Net yield for vaccine purchases varied from $3 to more than $24.

“Some practices are paying two to three times more than what other practices are paying for the exact same vaccine,” Freed said. “However, it is important not to confuse payment for vaccine purchase with payment for administration fees.”

Freed, who co-authored a paper on immunization programs for the Infectious Diseases Society of America that was published in Clinical Infectious Diseases, said that new combination vaccines have given pediatricians more options than ever to vaccinate, but they may be adding to gaps and confusion in reimbursement. He offered potential solutions for reducing these gaps.

“We found that some practices did not really know what they were paying for a vaccine or how much they were being reimbursed for a vaccine until we asked them to go back and check their records,” Freed said. “The more informed physicians are regarding the range of prices paid and the range of reimbursement, the better they will be to negotiate favorably.”

One way to reduce the cost of the vaccine itself is to enter into a vaccine purchasing cooperative — such as Children’s Practicing Pediatricians, a not-for-profit physician organization — which enables groups of small practices to band together and negotiate better rates.

In the meantime, the National Vaccine Advisory Committee Financing Workgroup and several AAP groups, including the Task Force on Immunization, the Task Force on Reimbursement and the Committee on Coding and Nomenclature, are collaborating to generate more national data on vaccine costs in at attempt to address factors that influence reimbursement disparities on the part of insurers.

Freed said he believes most financing issues regarding administration fees are in the public sector vaccine-purchase programs.

“Each state needs to come to the table with adequate reimbursement for administration fees or the potential exists for physicians to stop providing vaccines to some of our nation’s most vulnerable children,” Freed said. “In my opinion, combination vaccines should be the preferred choice, but we need to make sure that we do not unduly penalize providers for doing the right thing.” – by Nicole Blazek

For more information:

• Freed GS et al. Pediatrics. 2008;122:1319-1324.
• Freed GS et al. Pediatrics. 2008;122:1325-1331.
• Gidengil C. #3400.2 Presented at: Pediatric Academic Societies Annual Meeting; Baltimore: May 2-5, 2009.
• Kalies et al. Pediatr Infect Dis J. 2006;26:507-512.
• Marshall GS et al. Pediatr Infect Dis J. 2007;26:496-500.
• MMWR. 2006;56. General Recommendations on Immunization: Recommendations of the Advisory Committee on Immunization Practices.
• Zangwill KM et al. Pediatrics. 2008;122:e1179-e1185.