The Pennsylvania Health Care Cost Containment Council's enabling legislation, Act 89 of 1986 (as re-authorized by Act 34 of 1993), provides that the Council review existing or proposed mandated health benefits when requested by the executive and legislative branches of government.
Senator F. Joseph Loeper, Majority Leader and Chairman of the Senate Committee on Rules and Executive Nominations, requested that the Council review the provisions of House Bill 1873 (PN 2354, Representative Leonard Gruppo), which would require all children attending school to receive the hepatitis B vaccination. A copy of the bill is attached.
Notification was published in the Pennsylvania Bulletin, requesting that interested parties submit documentation and information pertaining to the bill to the Council. Letters were sent to potentially interested individuals and organizations informing them of the pending review and inviting them to submit documentation pursuant to the notice. Following the initial comment period, an opportunity was provided for interested individuals and organizations to examine the responses received. The Pennsylvania Department of Health and the Insurance Department were notified of the review and received a copy of the submissions. Respondents were also given an opportunity to submit a second round of documentation after examining the responses received. A list of documentation submitted to the Council is attached.
Act 34 provides for a preliminary Council staff review of submitted materials to determine if documentation submitted is sufficient to proceed with the formal Mandated Benefits Review process outlined in the Act. This report presents the result of the Council's preliminary staff review and the conclusions of the Council regarding whether the material is sufficient to proceed with the formal review process.
House Bill 1873 (97-98 session) amends the Hepatitis B Prevention Act of 1996, which requires hepatitis B immunization to all children enrolling in school. House Bill 1873 expands the hepatitis B immunization requirement to all children attending school. This bill would, in effect, serve as a "catch-up" provision for students in higher grades, requiring students from 4th to 12th grade to receive the hepatitis B vaccination before August 1, 1999. Children from first to third grades would have received the vaccination as condition of enrollment in school under the Hepatitis B Prevention Act of 1996 (this requirement began August 1, 1997). Children enrolling in school would continue to be required to receive the vaccination. While House Bill 1873 does not specifically mandate insurers to provide coverage for the hepatitis B vaccination, insurers are required to provide coverage for childhood immunizations under the Childhood Immunization Insurance Act of 1992.
In an effort to better understand this disease, Council staff conducted independent research and reviewed information included in the submissions received. This section discusses the risks, prevalence, prevention, treatments, and risk factors associated with hepatitis B.
Hepatitis B is an inflammatory liver disease caused by the hepatitis B virus, which is present in blood and body fluids of an infected individual. The virus is transmitted through contact of body fluids containing the hepatitis B virus, such as blood, semen, and vaginal secretions. The virus can survive outside of the body for at least 7 days on a dry surface. It can be transmitted through:
People at the greatest risk to contract the hepatitis B virus are:
A person's risk for infection depends upon their occupation, lifestyle, or environment. In the United States, over half of the hepatitis B reported cases are related to sexual contact, 12% are related to shared needles, 4% of cases occur by household contact with a chronic carrier, and 2% are health care workers. However, the source of infection is unknown for approximately 25% of persons who contract the virus. (While not specifically stated, the assumption was made that this source was referring to adult cases.) Of hepatitis B cases among adolescents with a known source for their infection, 50% can be attributed to sexual contact and 47% to injecting drug use.
The hepatitis B virus causes both acute and chronic hepatitis. Of those infected with the hepatitis B virus, the majority will never develop any symptoms. Often these individuals remain undiagnosed.
With acute hepatitis B, adults experience symptoms more often than infants or children; however, an estimated 50% of adults who have acute infections are asymptomatic. Patients who develop clinical signs and symptoms of acute hepatitis B often experience them in three phases. In the first phase, a patient with acute hepatitis B may experience severe weight loss, nausea, vomiting, abdominal pain, fever, headaches, and/or skin rashes. The initial phase may last 3 to 10 days. The next phase may last between 1 to 3 weeks and is characterized by the symptoms of dark urine and jaundice (the yellowish discoloration of skin and eyes). During the third or recovery phase, fatigue and anxiety may persist while jaundice, failure to regain weight, abdominal discomfort and other symptoms may disappear.
People who have not cleared the virus from their blood within 6 months are considered chronically infected and are carriers of the hepatitis B virus. Approximately 6% to 10% of all acute infections progress to chronic infections.
The risk for developing chronic infection is higher for infants and children. They are more likely to be unable to clear the virus from their systems and become chronic carriers. One source notes, "Things get much worse when children are involved. About 90% of infected infants (who usually get the virus before birth) become chronic carriers." Prenatal transmission accounts for 24% of all chronic hepatitis B infections. For children between the ages of 1 and 5 who become infected with the virus, 30% to 50% will become carriers. However, by adulthood, the risk of becoming a carrier decreases to 6% to 10%. As a person becomes older, their immune system becomes stronger which gives adults the ability to eliminate the hepatitis B virus from the blood and develop immunity against future infections.
Individuals who become chronically infected with the virus, especially children, are often asymptomatic. Some with chronic hepatitis B will never develop complications while other carriers develop insignificant or minimal liver disease. Others will develop cirrhosis (scarring of the liver) or liver cancer. Between 3,000 to 4,000 deaths in the United States are related to cirrhosis. Persons with chronic hepatitis B are at 12 to 300 times higher risk in developing liver cancer than noncarriers and it is estimated that 1,000 to 1,500 die each year in the United States of hepatitis B-related cancer. "An estimated 15% to 25% of people with chronic hepatitis B virus will die prematurely of cirrhosis or liver cancer."
Treatment options for hepatitis B are limited. The Food and Drug Administration approved the drug interferon for hepatitis B treatment; however, less than half of the patients with chronic hepatitis B can receive interferon. It is estimated that 30% to 35% of eligible patients will respond to the treatment, but they will experience side effects. Interferon has not been an effective method of treatment for children. (Council staff found no specific information regarding interferon's lack of effectiveness for children and some adults.) Some hepatitis B patients with cirrhosis are eligible for liver transplants; however, the supply of liver donors is limited and the procedure is costly. Several new treatments are being studied.
The submission from the Fox Chase Cancer Center noted that "treatment of chronic hepatitis B is unsatisfactory. It is expensive, has many side effects and has a failure rate of about 65%. Many patients with chronic hepatitis B eventually develop liver failure and require liver transplantation to save their lives."
Immunization for hepatitis B is seen as an effective means of preventing the hepatitis B infection and its consequences. For full protection against hepatitis B, three injections over a 5 to 12 month period are required. The hepatitis B vaccination schedule is first injection, then a second injection one-month later, and a third injection 5 months later. The vaccination dosage and schedule depends upon the age of the recipient. However, it is recommended that children, adolescents or adults complete the vaccination within 6 months.
After three doses of hepatitis B vaccine, a majority who receive the vaccination develop adequate antibody responses. The efficacy of the vaccine appears to be high. One study states that the vaccine is 80% to 100% effective in preventing the virus. Reasons for vaccine failure are vaccine handling, dosage, or schedule. Genetics, weight, and smoking are also contributing factors to vaccine failure. Age also contributes to the success or failure of the vaccination; for example, younger individuals respond better to the vaccination than older individuals.
Council staff found conflicting reports regarding booster doses of the hepatitis B vaccine. The National Vaccine Information Center notes that according to one pharmaceutical company, "the duration of the protective effect of the vaccine is unknown at present and the need for booster doses is not yet defined." The Department of Health and Human Services and the Centers for Disease Control and Prevention state, "For adults and children with normal immune status, booster doses of vaccine are not recommended, nor is routine serologic testing to assess immune status of vaccinees indicated. The need for booster doses after longer intervals will continue to be assessed, as additional information becomes available. Another study notes that responses to the vaccine "have largely been shown to be durable, although at least one booster dose after five to 10 years seems prudent, especially, if a low dose, yeast derived vaccine has been used." Another suggestion is "until the issue of the duration of immunity is resolved, booster shots should be considered every 10 years, at least in high risk populations."
The American School Health Association recommends that "all youth receive the hepatitis B vaccination, and they also urge school health professionals to initiate hepatitis B prevention programs to educate students and their parents about hepatitis B and its prevention." They also note that "only 1% of the 28 million young Americans are vaccinated against hepatitis B."
The Centers for Disease Control and Prevention state, "The suggested strategy to eliminate the transmission of the virus has been to vaccinate persons identified as high-risk. However, this strategy has not eliminated the incidence of hepatitis B primarily because vaccinating persons engaging in high-risk behaviors, life-styles, or occupations before they become infected has not been feasible. In addition, 25% to 30% have no identifiable source for the cause of their infection.
In order to eliminate the transmission of the hepatitis B virus and ultimately reduce the incidence of hepatitis B, the Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention is encouraging health providers to make the hepatitis B vaccine a part of all infants' immunizations schedule. The committee recommends that all newborns receive the vaccination, preferably before an infant is discharged from a hospital, but no later than when the infant is 2 months of age. Babies born to infected mothers should receive a vaccination within twelve hours of birth. In addition, the Centers for Disease Control and Prevention encourage physicians to screen pregnant women for the hepatitis B virus. The Advisory Committee on Immunization Practices states that "preventing the hepatitis B virus transmission during early childhood is important because of the high likelihood of chronic hepatitis B infection and chronic liver disease that occurs when children less than 5 years of age become infected." In addition, the Centers for Disease Control and Prevention also recommended 'catch up' immunization of adolescents and high-risk children and adults.
The hepatitis B virus is greatly underreported because of the high number of infections that are asymptomatic. The Centers for Disease Control and Prevention stated that there were a total of 10,637 reported cases of hepatitis B in 1996 in the United States, which is a relatively low incidence when compared to other countries.
The Centers for Disease Control and Prevention report the following hepatitis B related statistics in the United States:
The Pennsylvania Department of Health states:
According to the Centers for Disease Control and Prevention, the number of hepatitis B cases increased through 1985 and then declined 55% through 1993 because of wider use of vaccine among adults and a modification of high-risk behaviors. The Centers for Disease Control and Prevention commented that "hepatitis B continues to decline in most states, primarily because of a decrease in the number of cases among injecting drug users, and to a lesser extent, among both homosexuals and heterosexuals."
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