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© 2005 American Academy of Pediatrics
NEWS AND FEATURES |
by Trisha Korioth
Associate Editor
The Academy has released its revised policy statement, Prevention and Control of Meningococcal Disease: Recommendations for Use of Meningococcal Vaccines in Pediatric Patients (published online at www.aap.org/moc/immunizations/may05mv.htm).
The policy recommends administration of quadravalent meningococcal conjugate vaccine (MCV4, Menactra) to young adolescents at the 11- to 12-year visit, students entering high school or 15 year-olds (whichever comes first), and college freshmen who will be living in dormitories. MCV4 also is recommended for pediatric patients 11 years and older who are at increased risk of meningococcal disease (e.g., adolescents with asplenia or with complement deficiencies).
While the statement says MCV4 is preferred, use of the meningococcal polysaccharide vaccine (MPSV4, Menomune) is acceptable for certain adolescents at high risk (e.g., travelers to hyperendemic regions or for control of outbreaks).
Menactra, manufactured by sanofi pasteur, was licensed in January 2005 for use in 11- to 55-year-olds to protect against invasive meningococcal disease (IMD) caused by serogroups A, C, Y and W-135.
In February, the Centers for Disease Control and Prevention's (CDC's) Advisory Committee on Immunization Practices (ACIP) recommended use of MCV4 in the adolescent age group and submitted the recommendations to CDC for consideration. CDC is expected to publish parallel recommendations in the May 27 Morbidity and Mortality Weekly Report.
Building the adolescent platform
Although the peak age at risk for invasive meningococcal disease caused by serogroups A, C, Y and W 135 is 15- to 18-year-olds, administering the conjugate vaccine in 11- to 12-year-olds is expected to help strengthen the platform for the young adolescent well-care visit.
"Vaccination is just one part of that visit. It is the age when immunizations can be updated and all sorts of important young adolescent health care issues can be addressed," said Carol J. Baker, M.D., FAAP, author of the policy and member of the AAP Committee on Infectious Diseases (COID).
The new conjugate vaccine elicits higher protective levels than the polysaccharide vaccine at three years post-vaccination, said Dr. Baker.
Besides an expected longer duration of protection, Menacta also is "boostable" (a second dose three years later elicits high protective levels) whereas Menomune is not, she said. And unlike the polysaccharide, it is believed that the quadravalent conjugate vaccine will induce herd immunity as was found for the serogroup C conjugate in U.K. studies (Ramsay ME, et al. BMJ. 2003;326:365-366; Trotter CL, et al. Lancet. 2004;364:365-367).
Regarding herd immunity, "If you have 90% of people vaccinated, you begin to get protection in non-vaccinated people. It prevents you from acquiring colonization," Dr. Baker said.
Side effects of the conjugate vaccine generally are mild. "We will see some local reactions, she said. "Pain most commonly, redness or perhaps swelling."
There was no significant difference in reports of fever or other systemic symptoms in studies of adolescents who received Menactra vs. Menomune.
Reimbursement
Soon after FDA licensure was granted in January, pharmaceutical representatives began taking orders for Menactra. This led to confusion among some clinicians, who heard about the licensure and, subsequently, ACIP recommendations reported through the national news media and questioned whether to begin administering vaccine.
"In fact, ACIP is the recommending body to the CDC, just as the COID makes recommendations to the AAP Board of Directors. CDC recommendations do not become 'official' until they are published in the MMWR," said COID Chair Margaret B. Rennels, M.D., FAAP.
AAP recommendations are not official until they are published in Pediatrics or on the AAP Web site.
The AAP policy calls for "public and private insurers (to) be responsible for payment of costs of MCV4, its administration to adolescents for whom MCV4 is recommended, and administrative costs involved in providing vaccines to high-risk people."
Dr. Baker said the Vaccines for Children program is expected to cover Menactra soon after the AAP policy statement's release.
Whether managed care organizations will be quick to reimburse is "highly variable," said Thomas K. McInerny, M.D., FAAP, chair of the AAP Committee on Child Health Financing.
"Managed care companies have different ways of addressing starting to reimburse for a new vaccine. Some of them do it very promptly and others frankly tend to drag their feet about it, which is a problem. Right now we have college students and 11 to 12 and 15-year-old children who are planning to go to camp in the summer;for both of whom this new vaccine is a recommendation," he said.
Another concern of clinicians is the rate at which the "relatively expensive" Menactra vaccine will be reimbursed. "This raises the issue of how pediatricians are reimbursed for vaccines that they purchase," said Dr. McInerny. "Currently, for the most part, the managed care organizations pretty much dictated the price that they will reimburse for the purchase of the vaccine. Usually they pick something like the average wholesale price."
This does not always cover expenses for explaining risks and benefits to parents and adolescents; ordering, purchasing, storing and administering vaccine; record-keeping; insurance for the vaccine in case of power failure and other costs, he added.
"There are several new vaccines on the near horizon. Why do we have to go through this every time we have a new vaccine?" said Dr. McInerny.
The Academy advocates for a coordinated process by which new vaccines can be introduced into the vaccination schedule in a timely fashion. Detailed information, including a document that identifies the direct and indirect costs for vaccines, is available on the AAP Member Center (www.aap.org/moc), click on the links to Private Sector Advocacy and Practice Management.
Coding
The following CPT codes can be used for administering the immunization:
90471 Immunization administration (includes percutaneous, intradermal, subcutaneous or intramuscular); one vaccine (single or combination vaccine/toxoid)
+90472 Immunization administration (includes percutaneous, intradermal, subcutaneous or intramuscular); each additional vaccine (single or combination vaccine/toxoid) (List separately in addition to code for primary procedure)
Providers can code for both the administration of the immunization as well as for the vaccine product.
To report the first immunization given during a single patient encounter, report code 90471. Code 90472 is considered an "add-on" code (hence the "+" symbol next to it) to code 90471. This means that the provider will report 90472 in addition to 90471 if more than one vaccine is administered during a single patient encounter.
The provider will code for the administration of each immunization given during the visit. If, for example, four injectable immunizations are given during a single visit, the provider will code 90471 once and 90472 three times (or, if coding in "units," three units of 90472). It is imperative that the "add-on" code (90472) is not used without the code for the first immunization administration (90471).
The CPT codes used in reporting the meningococcal vaccine products are:
90734 Meningococcal conjugate vaccine, serogroups A, C, Y, and W-135 (tetravalent), for intramuscular use (Menactra)
90733 Meningococcal polysaccharide vaccine, for subcutaneous use (Menomune)
For providers enrolled in the Vaccines for Children program, whose state summplies meningococcal vaccine, the cost of the vaccine product is not billable to the insurance carrier. However, the appropriate CPT codes still can be used to account for the vaccine products given during a visit, but the charge field on the claim form should be zeroed out.
ICD-9-CM Coding - Diagnosis codes are used along with CPT codes to reflect the outcome of a visit. CPT codes tell a carrier what was done, and ICD-9-CM codes tell a carrier why it was done.
The ICD-9-CM code used in reporting the meningococcal vaccine products is:
V03.89 Need for prophylactic vaccination and inoculation against bacterial diseases; other specified vaccinations against single bacterial diseases; other specified vaccination
The vaccine product CPT code (e.g., 90734) and its corresponding immunization administration CPT code (e.g., 90471) always are linked to the same ICD-9-CM code. This is because both the vaccine product and the work that goes into administering that product are intended to provide prophylactic vaccination against a certain type of disease.
For specific coding examples and information on when is it appropriate to report CPT code 99211 in addition to the immunization administration code(s), visit the AAP Member Center (www.aap.org/moc) and click on the Coding & RBRVS link.
Research on serogroup B
The A, C, Y and W 135 meningococcal conjugate and polysaccharide vaccines protect against about 70% of adolescent cases of IMD. However, no vaccine exists in the United States against serogroup B, which is responsible for at least 25% to 30% of cases in adolescents and at least half of all cases in infants.
Two countries, Cuba and New Zealand, have vaccines against group B meningococcal disease, said Dr. Baker.
"That is because in those two countries, all of the disease is due to one clone," she said. "In the United States and Western Europe, we have multiple serogroup B clones."
Previous attempts at creating a vaccine that covers across group B strains have been unsuccessful, but early design of vaccines including animal studies are ongoing, she said.
Expanding recommendations
In March, sanofi pasteur filed a supplemental biologics license application with the Food and Drug Administration to amend the license for MCV4 to include 2- to 10-year-olds.
If FDA grants supplemental licensure, the CDC and Academy could revise its recommendations to include this age group. Current recommendations state that the polysaccharide vaccine should be given to 2- to 10-year-olds who are at increased risk of meningococcal disease.
Further revisions to Academy and CDC recommendations likely will address whether and when to administer booster doses. In addition, CDC anticipates expanding its recommendation to include all children over age 11 as supplies increase and more data become available.
"This vaccine is recommended for good public health reasons," said Dr. Baker. "It is not inexpensive, but it is well worth preventing this devastating disease."
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