Mandated Benefits Review by the Pennsylvania Health Care Cost Containment Council

House Bill 1873 (97-98 session)

Hepatitis B Immunization

January 1999 Table of Contents

Executive Summary ...... 1

Review of House Bill 1873 ...... 3

Mandated Benefits Review Process ...... 3

Overview of House Bill 1873 ...... 3

Overview of Hepatitis B ...... 4

Staff Summary of the Documentation Submitted ...... 8

References ...... 16

List of Submissions for House Bill 1873 ...... 17

Copy of House Bill 1873 ...... 21 Executive Summary

After reviewing the staff analysis of House Bill 1873 (97-98 session), the Pennsylvania Health Care Cost Containment Council does not find evidence to recommend the passage of this legislation in its current form. While we recognize that prevention— through immunization—is an effective method in combating this chronic disease, we did not find evidence to recommend acceleration of the hepatitis B immunization program as currently outlined in this bill.

Starting in August of 1997, children enrolling in school were required to receive the hepatitis B vaccine. House Bill 1873 calls for the Secretary of Health to place hepatitis B on the list of diseases that require immunization for attendance at school after August 1, 1999. This bill, then, would serve as a “catch-up” program for students in higher grades—those who enrolled in school before August of 1997 (i.e., students in 4th through 12th grades in 1999).

We note the following points:

· While House Bill 1873 does not specifically call for a mandated benefit, every new immunization benefit, in effect, becomes a mandated insurance benefit through the mechanics of the Childhood Immunization Insurance Act of 1992. Under this act, insurers are required to provide coverage for immunizations recommended by the Centers for Disease Control and Prevention. Hepatitis B is currently one of the recommended immunizations.

· Issues of practicality were raised with vaccinating all students from grades 4th to 12th by August 1, 1999. In order to comply with this “catch-up” measure, over 700,000 students will have to receive the full hepatitis B immunization by August 1, 1999. For full immunization against the hepatitis B virus, three separate doses are administered over a 5 to 12 month time frame.

· We note that there are several immunization programs already established in Pennsylvania. The Department of Health has developed programs to assure that children are immunized against the hepatitis B virus. In 1997, the Division of Immunization of the Pennsylvania Department of Health implemented the Hepatitis B Catch-Up Project, which aims at vaccinating seventh grade students against the virus. The Department of Health is also working to make the vaccine more accessible to the public through the Vaccine for Children’s Program. The Department also implemented the federally funded Prenatal Hepatitis B Prevention Program. This program is designed to assure the availability of treatment and follow- up for high-risk infants born to hepatitis B positive women.

· In lieu of the “catch-up” measure called for in House Bill 1873, an alternative solution was submitted by the Pennsylvania Chapter of the American Academy of Pediatrics. They recommend “that the requirement of House Bill 1873 be phased in with the 6th and 11th grade physicals until all children are ‘caught up.’”

· House Bill 1873 would not interfere with the current mandate of immunizing students enrolling in school. At issue is whether all 4th to 12th graders should receive the

- 1 - · hepatitis B immunization before the next school year. The Council did not receive sufficient information indicating that there is a need to immunize over 700,000 students against the hepatitis B virus by August 1, 1999. With regard to cost, this initiative represents a one-time cost estimated to be between $21.9 million and $52.7 million.

· Finally, the Council’s enabling legislation provides for a preliminary staff review of submitted materials to determine if documentation received is sufficient to proceed with the formal Mandated Benefits Review process outlined in Act 34 of 1993. We conclude that neither supporters nor opponents of the bill provided sufficient information to warrant a full review by a Mandated Benefits Review Panel; nor, given the documentation received, do we believe a panel of experts would come to conclusions different than the ones reached here.

- 2 - Review of House Bill 1873

The Mandated Benefits Review Process

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.

Overview of House Bill 1873

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.

- 3 - Overview of Hepatitis B

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.

Risk Factors

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:

· sexual contact · an infected mother to her newborn during delivery · exposure to sharp instruments contaminated with infected blood, such as in tattooing and body piercing · sharing razors, nail files, or toothbrushes with an infected person · blood received before hepatitis B testing was available (1975)

People at the greatest risk to contract the hepatitis B virus are:

· sexually active adults and teenagers · all infants of mothers who have the virus at time of delivery · people who share needles · health care workers (people in occupations that have contact with blood) · travelers to developing countries · families adopting children from countries where the hepatitis B virus is common (Asia, Eastern Europe, South America, Africa) · inmates in correctional facilitiesi

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.ii (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.iii

Acute and Chronic Hepatitis B

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.iv

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.

- 4 - 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.v

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.vi

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.vii 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.viii 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%.ix 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.x “An estimated 15% to 25% of people with chronic hepatitis B virus will die prematurely of cirrhosis or liver cancer.”xi

Treatment

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.xii 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.)xiii 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.”

- 5 - Vaccinations and Prevention

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.xiv

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.xv 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.xvi

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.”xvii 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.xviii 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.”xix 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.”xx

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.”xxi

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.xxii

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

- 6 - 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.xxiii

Incidence/Prevalence

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.xxiv

The Centers for Disease Control and Prevention report the following hepatitis B related statistics in the United States:

· An estimated 1 to 1.25 million Americans are chronically infected with the hepatitis B virus. · Each year, an estimated 140,000 to 320,000 Americans become infected with the hepatitis B virus. · 8,400 to 19,000 hospitalizations related to the hepatitis B virus occur each year. · Of all hepatitis B infections, 5,000 to 6,000 people die every year from chronic liver disease including primary liver cancer. · 70% of new cases occur among ages 15 to 39, in which 75% are teenagers. · Hepatitis B infections in teenagers have increased 27% over the past decade.xxv

The Pennsylvania Department of Health states:

· 361 new cases of hepatitis B were reported in 1997 in Pennsylvania.xxvi · An estimated 500-600 pregnant women are carriers of the virus in Pennsylvania. · Each year, an estimated 22,000 infants are born to women who have the hepatitis B virus.xxvii

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.”xxviii

- 7 - Staff Summary of the Documentation Submitted (in response to the eight requirements of Act 34, Section 9)

(i) The extent to which the proposed benefit and the service it would provide are needed by, available to and utilized by the population of the Commonwealth.

House Bill 1873 requires that all children receive the hepatitis B vaccination for school attendance. This bill amends the Hepatitis B Prevention Act of 1996, which required the Secretary of Health to designate hepatitis B on the list of diseases requiring immunization for entry (kindergarten and first grade) into school after 1997. House Bill 1873 would, in effect, serve as a “catch up” provision requiring students in higher grades, those who enrolled in school before August of 1997 (4th through 12th grade students), to receive the vaccination before August 1, 1999.

While there were 361 reported cases of hepatitis B in 1997 in Pennsylvania, the ages and source of infection of the 361 reported cases were not supplied to the Council; therefore, insufficient information was received to determine whether there is a specific need for the elementary and secondary school age population to receive the vaccination as part of a one-time “catch-up” provision before August 1, 1999.

Information received suggests that immunizations for hepatitis B are readily available to the residents of Pennsylvania. In addition to receiving the vaccination at a physician’s office, one study notes that the Centers for Disease Control and Prevention suggest that “adolescents can be vaccinated in school-based clinics, community health centers, family planning clinics, clinics for the treatment of sexually transmitted diseases and special adolescent clinics.”xxix

The Division of Immunization of the Pennsylvania Department of Health is working to make the vaccination even more accessible to the public. The Department of Health implemented the federally funded Prenatal Hepatitis B Prevention Program. This program is designed “to assure that appropriate follow-up and treatment for high-risk infants born to hepatitis B positive women is available.” In addition, the vaccine is available through the Department of Health’s Vaccine for Children’s Program. In 1997, the Pennsylvania Department of Health initiated a school based Hepatitis B Catch Up Project to provide the hepatitis B vaccine to seventh grade students.

Based on information received by the Pennsylvania Department of Health, approximately 50% of the elementary and secondary students have received the hepatitis B vaccination.

(ii) The extent to which insurance coverage for the proposed benefit already exists, or if no such coverage exists, the extent to which this lack of coverage results in inadequate health care or financial hardship for the population of the Commonwealth.

Insurers are required to provide coverage for the hepatitis B vaccine under the Childhood Immunization Insurance Act of 1992. Under this act, insurers are required to

- 8 - provide coverage for immunizations recommended by the Centers for Disease Control and Prevention. Hepatitis B is currently one of the recommended immunizations.

The Insurance Federation of Pennsylvania discusses the Childhood Immunization Insurance Act of 1992 in their submission. They commented, “Having been required by legislation since 1992 to cover these immunizations, there is no point in raising issues about that scheme. The net result…, however, is that every new immunization benefit becomes a mandated insurance benefit through the mechanics of the 1992 act.”

The Highmark submission stated, “Presently, Highmark BlueCross BlueShield policies provide immunization coverage for children and youth up to and including age 20.”

The Pennsylvania Department of Health notes that, “The Children’s Health Insurance Program is being expanded in Pennsylvania and more children will have access to insurance coverage for immunizations through their private health provider.”

From the submissions received, it appears that immunization for hepatitis B is widely available through insurance coverage and targeted programs. The submissions provided to the Council did not illustrate that inadequate coverage for the hepatitis B vaccine exists, nor did they prove inadequate health care or financial hardship as a result.

(iii) The demand for the proposed benefit from the public and the source and extent of the opposition to mandating the benefit.

Support for the Proposed Benefit Called for in House Bill 1873

While the Council received little information illustrating public demand, submissions did discuss general support for immunizing all students attending school.

According to the Fox Chase Cancer Center, “Hepatitis B is a very common, potentially lethal disease; yet it is almost completely preventable. Hepatitis B vaccination of school age children is about 98% effective in preventing infection with the hepatitis B virus.”

Another submission from the Fox Chase Cancer Center notes, “The vaccination program for hepatitis B, and the cigarette smoking cessation programs are the two most effective cancer prevention programs currently available.”

The Hepatitis Foundation International writes, “There are over 1.2 million carriers of hepatitis B in the United States, many of whom are unaware of their infection. In the majority of cases there are no signs or symptoms until the liver damage is far advanced.”

The Parents of Kids with Infectious Disease state, “We see it every day by the number of parents who contact us on first receiving the terrible news – they share disbelief, heartache, and grief. There are thousands of parents who have not yet contacted us for the simple reason that they don’t know their children have an infectious disease. More than 40% of the over 1 million Americans chronically infected with hepatitis B were initially infected before their 19th birthday, with over half of that infected at birth.”

- 9 - In supporting House Bill 1873, the Hepatitis B Foundation writes that many people affected by hepatitis B are “young adults or parents of young children who were unknowingly infected. Yet, all of these sad stories could have been prevented through vaccination.”

Jefferson Medical College states, “There are too many diseases that can not be prevented. By including hepatitis B vaccination in the already existing schedule of required immunization, we can protect these children not only from acute or chronic hepatitis but also cirrhosis and most primary liver cancer.”

The Centers for Disease Control and Prevention recommend “catch-up” immunization programs for adolescents and high-risk children and adults, however, they suggest that universal infant immunization programs are easier to implement than “catch-up” adolescent programs. “Catch-up vaccination in these groups is important because 92% of the acute infections that are reported occur in adolescents and adults. Correspondingly, 64% of the chronic infections that develop each year are derived from this population. As over 99% of children in the United States remain in school until age 13, vaccine delivery programs targeted at adolescents can significantly expand the benefits of the vaccine."xxx

Opposition to House Bill 1873 Including Concern Regarding Acceleration of Vaccination Program

While the Council received little information suggesting opposition to this specific measure, there were submissions expressing concern regarding the acceleration of the vaccination schedule.

The Pennsylvania Chapter of American Academy of Pediatrics notes that they continue to “recommend that school immunization requirements mirror the Centers for Disease Control, Advisory Committee on Immunization Practices/American Academy of Pediatrics/American Academy of Family Physicians joint immunization schedule rather than add immunizations one by one to the required school list.” The Pennsylvania Chapter of American Academy of Pediatrics adds, “It should be noted that there were significant problems with children being denied registration for school this past spring because their immunizations were not up to date. Pennsylvania law allows for children to have provisional entry to school while they are, in good faith, completing their immunizations. Because hepatitis B is a series of three inoculations, it is imperative that schools adequately prepare parents for this new requirement. The Pennsylvania Chapter of American Academy of Pediatrics recommends that the requirement in House Bill 1873 be phased in with 6th and 11th grade physicals until all children are ‘caught up.’ These physicals are routine and therefore provide physicians, parents, and school staff the opportunity to include the hepatitis B requirement with the completion of the physical.”

The Insurance Federation of Pennsylvania “does not oppose the bill as it does most insurance mandates.” The Insurance Federation has concerns, however, regarding the acceleration of the hepatitis B vaccination, “The single issue for the Council is whether the best medical practice dictates that the Commonwealth accelerate its hepatitis B immunization requirement so that all youngsters attending school in the first twelve grades must be immunized by the start of the school year commencing a year from now. This is a departure from the current, more gradual schedule in which entering

- 10 - kindergarten and first grade students are required to be immunized. This, too, eventually achieves the full immunization of the school age population, but on a slower schedule.” They continue, “Clearly, if the best medical advice is that the failure to completely cover the school age population immediately, rather than over a half dozen years, will mean any significant rise in the incidence of this disease, the Council should support the acceleration of the immunization schedule represented by the bill.”

One study notes the concerns of parents regarding the vaccination for hepatitis B by stating, “Initial reasons given by parents for not accepting immunization for their infants was safety of the vaccine, a perceived lack of need for the product, and cost.”xxxi

General Opposition to Health Insurance Mandates

Highmark noted, “Even though Highmark BlueCross BlueShield provides coverage for the hepatitis B vaccine, we cannot ignore the fact that House Bill 1873 represents yet another mandated benefit proposal. We believe that the inclusion of new benefits should be determined solely by purchasers – individuals, large and small group customers and the labor community. They alone should have the option of selecting the benefit options that best meet their needs. Mandates also contribute to increases in health insurance premiums and the number of uninsured Pennsylvanians.”

Insurers and purchasers of health care express strong opposition to the general idea of legislatively imposed health care mandates. In general, they contend that mandates result in rising health insurance costs, which cause employers and individuals to drop coverage, and thereby contribute to the increasing number of uninsured. The following are some of the arguments made by opponents of mandates:

· Mandated benefits increase premiums, which may result in employers dropping health benefits for their employees. When employers who have cancelled health insurance benefits have been polled on why they did so, the majority claimed that it was because the price was too high. Lower-income workers were the most likely to lose coverage. Employers who provide health care coverage will be faced with additional costs through mandates, thus putting them at a competitive disadvantage. Increased costs also result in more employees declining coverage when it is offered by their employer. According to a recent study, 75% of workers purchased coverage through their employers in 1989; in 1996, this figure had dropped to 70%.

· The cost of mandated benefits is usually borne by employees in the form of increase premium cost, reduced benefits or wages, or loss of employment.

· Mandates cause an increasing number of large employees to self-insure, thus avoiding such mandates. The market covered by mandates then “becomes the province (and problem) of smaller businesses.”xxxii Small businesses and individuals lack the purchasing power of larger groups. Therefore, any increase in premiums will disproportionately affect individual purchasers and small businesses. Some small employers “can barely afford the standard benefit package.”xxxiii

· Some benefits may not be appropriate for a particular group. Mandates limit the ability of purchasers to structure benefits packages based on the needs of specific groups.

- 11 - · By increasing health care costs, mandates have the potential to increase the number of uninsured. In Pennsylvania the percentage of insured increased from 8.6% in 1987 to 11.6% in 1995, a period during which seven mandates were enacted. Costs may be shifted to the government because no coverage exists.

(iv) All relevant findings bearing on the social impact of the lack of the proposed benefit.

The social impact for persons with hepatitis B is described by the Hepatitis Foundation International, “Like the children with AIDS who were shunned and ostracized several years ago, children with hepatitis B are being treated like the plague. People are fearful of catching this disease that they can’t see, or feel and know little about except that people turn yellow when they have it, which incidentally, is a misnomer. Most people do not become jaundiced, nor do they have any signs that they are infected. Parents are reluctant to tell anyone that their child is infected, protecting them from the heartache of being shunned by their friends. Tragically, the silence creates an uncontrollable risk to their classmates who may come into personal contact with these infected children.”

Parents of Kids with Infectious Disease states, “When news gets out that their child has Hepatitis B, playmates suddenly can’t come over anymore and the school staff at best act a bit funny. Babysitters are always informed, so finding willing babysitters is impossible.”

(v) Where the proposed benefit would mandate coverage of a particular therapy the results of at least one professionally accepted, controlled trial, comparing the medical consequences of the proposed therapy, alternative therapies, and no therapy.

House Bill 1873 does not call for coverage of a particular therapy.

(vi) Where the proposed benefit would mandate coverage of an additional class of practitioners, the result of at least one professionally accepted, controlled trial comparing the medical results achieved by the additional class of practitioners and those practitioners already covered by benefits.

House Bill 1873 does not call for coverage of an additional class of practitioners.

(vii) The results of any relevant research.

Information regarding research is discussed in other sections of this report.

- 12 - (viii) Evidence of the financial impact of the proposed legislation, including at least:

(A) The extent to which the proposed benefit would increase or decrease cost for treatment or service.

Since House Bill 1873 expands the hepatitis B immunization requirement to all children attending school, the utilization of the vaccine would increase, which would lead to an increase in the total cost. The Council received no information, however, suggesting the cost of the vaccine, itself, would increase. It does appear that the increase in cost to implement this “catch-up” measure is a one-time expense. The Council, however, did not receive sufficient information to determine the specific increases or decreases in cost for this treatment or service.

(B) The extent to which similar mandated benefits in other states have affected charges, costs and payments for services.

While some “catch-up” programs have been implemented, no state has enacted legislation exactly like House Bill 1873. For example, catch-up projects were implemented in San Francisco (California), Baton Rouge (Louisiana), and Oregon. The programs provided incentives and free vaccine. There were health care providers available at the schools to provide the vaccination. Over 75% of the parents consented to having their child immunized and 65% to 78% of the students completed the three doses. There was no information supplied regarding the cost.xxxiv

(C) The extent to which the proposed benefit would increase the appropriate use of treatment or service.

In addressing the appropriate use of the hepatitis B vaccine, studies submitted suggest that the age group in question (4th to 12th grade students) is the appropriate group to receive this vaccine. The Centers for Disease Control and Prevention “recommend a universal vaccination of all adolescents through private and public health vaccination programs with a target on young adolescents in the middle school setting.”xxxv

(D) The impact of the proposed benefit on administrative expenses of health care insurers.

The Council received no submissions regarding administrative expenses. By enacting House Bill 1873, the administrative costs insurers would experience include the increased costs associated with filing claims.

(E) The impact of the proposed benefit on the benefits costs of purchasers.

Although submissions did not specifically address the amount of increase on the benefit costs of purchasers, Council received a cost projection to implement House Bill 1873, which is discussed in the following section. One could assume, however, that if insurers costs increase as a result of enacting this legislation, the cost might be passed along to the purchasers.

- 13 - (F) The impact of the proposed benefits on total cost of health care within the Commonwealth.

Insufficient information was received to identify precisely how this legislation would affect the total cost of health care in Pennsylvania. In addressing their concerns in expanding the hepatitis B immunization to students attending school, the Insurance Federation of Pennsylvania estimated the cost of covering this measure to be $66 million. The Insurance Federation states that “if 2,115,373 K through 12 schoolchildren in public and private schools required three shots at $11 each, this could cost $66 million. This certainly fails to account for a number of conditions which should reduce that cost estimate for the Blues and the commercial health insurers represented by the Federation.”

The Insurance Federation explains, “The existing program has presumably inoculated the vast majority of children in grades K through 3, reducing the burden by 4/13. Second, perhaps as many as 25% of children would be covered through Medicaid which, while still a cost, would not be visited on commercial insurers. Third, some 10% of children are presumably not insured at all. Finally, some school district surveys suggest that perhaps as many as 50% of the remainder of the children remaining after the above groups are discounted, have already received the immunization. If these reductions from the full school population are realistic, it means that the cost, allocated between the Blues and commercial insurers, is considerably less frightening, perhaps in the range of $10 to $15 million.”

As noted previously, the “catch-up” costs to immunize children in grades 4th to 12th against the hepatitis B virus would be a one-time expense. Those children entering kindergarten and 1st grade would continue to receive the vaccine under the Hepatitis B Act of 1996.

Council Cost Estimates

The following cost estimates were calculated by Council staff based upon independent research and information submitted in response to House Bill 1873.

Population Affected. Broad assumptions were used to estimate the population who would receive the hepatitis B vaccination to comply with the measures under House Bill 1873. According to information received from the State Data Center, a total of 1,463,977 students (grade 4th through 12th) in 1999 would be affected by the measure in House Bill 1873. Based on information received by the Pennsylvania Department of Health, it was estimated that 50% of children in this age group have already received the hepatitis B vaccination. Council staff estimates the potential number of students that will need to receive the vaccination for the 1999 school year is 731,989.

Vaccine Costs. Council staff estimated the cost of the hepatitis B vaccination based upon information from the Pennsylvania Department of Health. Staff estimates the cost of the adolescent vaccine to be between $30 and $72 for three doses (based on a cost range between $10 to $24 per dose as provided to the Council).

Projected Costs. Using the population estimates, utilization rates, and cost information, the total cost of the “catch-up” measure is estimated to be between $21.9 million and $52.7 million (731,989 x $30 = $21.9 million; 731,989 X $72 = $52.7 million).

- 14 - Other Policy Considerations

Based on the information submitted, Council staff notes several policy considerations.

Vaccinating all students from grades fourth to twelfth grade by August 1, 1999 raises issues of practicality. Students from grades fourth to twelfth grade must receive 3 doses of the vaccination in order to develop immunity against the hepatitis B virus and to comply with the measures in House Bill 1873. That is, over 700,000 students must receive the full hepatitis B vaccination by August 1, 1999.

The American Academy of Pediatrics states, “that there were significant problems with children being denied registration for school this past spring because their immunizations were not up to date.” They note that, “because Hepatitis B is a series of three inoculations, it is imperative that schools adequately prepare parents for this new requirement.”

An alternative solution was submitted by the Pennsylvania Chapter of the American Academy of Pediatrics. They recommend “that the requirement of House Bill 1873 be phased in with the 6th and 11th grade physicals until all children are ‘caught up.’”

Infant immunization might be more cost effective than adolescent immunization. Several studies suggest that immunizing infants might be more cost effective than immunizing adolescents. The Centers for Disease Control and Prevention note, “Vaccinating adolescents and adults is substantially more expensive because of the higher vaccine cost and the higher implementation costs of delivering vaccine to target populations. In the long term, universal infant vaccination would eliminate the need for vaccinating adolescents and high-risk adults.”xxxvi Immunization for infants is recommended because:

· the cost of the infant vaccine is lower than the adult vaccine · the hepatitis B vaccine can be incorporated into the infant’s routine vaccination schedule · infants are at a higher risk of developing chronic hepatitis B

The Pennsylvania Department of Health has taken steps to assure that all children are immunized against hepatitis B. As stated previously, the Department of Health has developed and implemented several programs that provide information about this disease and vaccination. Along with providing information on hepatitis B, the Department of Health also has programs that provide the vaccination to infants and teenagers 18 years of age with no or little charge to the parents.

- 15 - References

1 “Hepatitis B,” Hepatitis B Foundation, New Jersey. 2, 4, 5, 6, 9, 10, 12, 14, 15, 18, 22, 28 William Atkinson, MD, MPH, et al., “Hepatitis B.” Epidemiology and Prevention of Vaccine-Preventable Diseases, 2nd ed., Centers for Disease Control and Prevention, 1995, pp. 139-158. 3, 8 Craig Shapiro, MD, “Epidemiology of hepatitis B,” The Pediatric Infectious Disease Journal, Vol. 12, No. 5, 1993, pp. 433-437. 7 “Someone You Know Has Hepatitis B,” Hepatitis B Foundation, Pennsylvania. 11 Pierre Pare, MC, FRCPC, FACG, “The Clinical Consequences of Chronic Hepatitis B,” [email protected], Quebec, Canada, 1996. 13 Raymond S. Koff, MD, FACP, “Hepatitis B today: clinical and diagnostic overview,” The Pediatric Infectious Disease Journal, Vol.12, No.5, 1993, pp. 428-432. 16 Samuel Lee, MD, FRCPC, “Hepatitis B: Questions and Answers,” [email protected], Quebec, Canada, 1997. 17, 24 Karin Schumacher, “Hepatitis B Disease and Vaccine Facts,” National Vaccine Information Center, [email protected], Virginia, 1996-1997. 19, 23, 30, 31, 34 F B Hollinger, “Comprehensive control (or elimination) of hepatitis B virus transmission in the United States,” Baylor College of Medicine, Houston, Texas, pp. S24-S30. 20, 35 Alan L. Hillman, MD, et al., “Cost Effectiveness of Hepatitis B Immunization Strategies,” Pharmaco Economics. Vol. 5, No. 2, 1994, pp. 85-87. 21 American School Health Association’s Resolution of Hepatitis B Immunization, 1994. 25 “Hepatitis B Fact Sheet,” Centers for Disease Control and Prevention, www.cdc.gov, 1998. 26 Pennsylvania Department of Health, Division of Statistics. 27 Pennsylvania Department of Health, Prenatal Hepatitis B Program, www.health.state.pa.us, 1998. 29 “Immunization of Adolescents: Recommendations of the Advisory Committee on Immunization Practices, the American Academy of Pediatrics, the American Academy of Family Physicians, and the American Medical Association, “ Morbidity and MortalityWeekly Report, Vol. 45, 1996. 32 Independent Insurance Agents of Pennsylvania, Letter from Vince Phillips, July 1998. 33 Highmark. Submission to the Health Care Cost Containment Council for Senate Bill 499. July 2, 1998. 36 Immunization Practices Advisory Committee, “Hepatitis B: A Comprehensive Strategy for Eliminating Transmission in the United State Through Universal Childhood Vaccination,” Morbidity and Mortality Weekly Report, Vol. 40, 1991, pp. 1-25.

- 16 - House Bill 1873 Submissions Hepatitis B Immunization

1. Highmark (Bruce R. Hironimus, Vice President of Government Affairs) A. Letter addressing hepatitis B immunization.

2. Hepatitis B Foundation (Joan M. Block, R.N., President) A. Letter supporting hepatitis B immunization. B. “B • Informed.” Newsletter of the Hepatitis B Foundation. No. 23. Spring/Summer 1998. C. “Someone You Know Has Hepatitis B” pamphlet. D. “Protect Yourself and Those You Love From Hepatitis B” pamphlet.

3. American Academy of Pediatrics, Pennsylvania Chapter (Bradley J. Bradford, M.D., President) A. Letter supporting hepatitis B immunization.

4. Parents of Kids with Infectious Diseases (Trish Parnell) A. Letter supporting hepatitis B immunization.

5. Representative John M. Perzel, Majority Leader of the Pennsylvania House of Representatives A. Letter supporting House Bill 1873. B. Atkinson W, Furphy L, Gantt J, and Mayfield M. “Hepatitis B.” Epidemiology and Prevention of Vaccine-Preventable Diseases, 2nd edition. Centers for Disease Control and Prevention. July 1995. Pages 139-158. C. American Academy of Pediatrics. “Hepatitis B.” 1997 Red Book: Report of the Committee on Infectious Diseases, 24th edition. American Academy of Pediatrics. 1997. Pages 247-260. D. Recommendations of the Immunization Practices Advisory Committee. “Hepatitis B Virus: A Comprehensive Strategy for Eliminating Transmission in the United States Through Universal Childhood Vaccination.” Morbidity and Mortality Weekly Report. November 22, 1991. Vol 40. Pages 1-25. E. Lee W. “Hepatitis B Virus Infection.” The New England Journal of Medicine. December, 1997. Vol. 334: No. 24. Pages 1733-1745. F. Andre FE. “Overview of a 5-year clinical experience with a yeast-derived hepatitis B vaccine.” Vaccine. 1990. Vol. 8: Supplement 1990. Pages S74-S78. G. Hollinger FB. “Comprehensive control (or elimination) of hepatitis B virus transmission in the United States.” Pages S24-S30. H. Hyams KC. “Risks of Chronicity Following Acute Hepatitis B Virus Infection: A Review.” Clinical Infectious Diseases. 1995. Vol 20. Pages 992-1000. I. Shapiro CN. “Epidemiology of hepatitis B.” The Pediatric Infectious Disease Journal. 1993. Vol. 12, No. 5. Pages 433-437. J. Koff RS. “Hepatitis B today: clinical and diagnostic overview.” The Pediatric Infectious Disease Journal. 1993. Vol. 12, No. 5. Pages 428-432. K. Andre FE and Zuckerman AJ. “Review: Protective Efficacy of Hepatitis B Vaccines in Neonates.” Journal of Medical Virology. 1994. Vol. 44. Pages 144-151. L. Andrew FE and Safary A. “Protective efficacy studies with a hepatitis B recombinant DNA vaccine.” Abstract. 23rd Meeting of the European Association for the Study of the Liver. Leuven, Belgium, August 1988. M. McMahon BJ, Mandsager R, Wainwright R, Williams J, and Singleton R. “The Alaska native hepatitis B control program.” Pages 702-704. N. Margolis HS, Coleman PJ, Brown RE, Mast EE, Sheingold SH, and Arevalo JA. “Prevention of Hepatitis B Virus Transmission by Immunization.” JAMA. 1995. Vol. 274, No. 15. Pages 1201- 1208. O. “The Public’s Health Unprotected: Reversing a Decade of Underutilization of Hepatitis B Vaccine.” Editorial. JAMA. 1995. Vol. 274, No. 15. Pages 1242- 1243.

- 17 - P. Margolis HS, Schatz GC, and Kane MA. “Development of recommendations for control of hepatitis B virus infections: the role of cost analysis.” Vaccine. 1990. Vol. 8, Supplement 1990. Pages S81-S85. Q. Bloom BS, Hillman AL, Fendrick AM, and Schwartz JS. “A Reappraisal of Hepatitis B Virus Vaccination Strategies Using Cost-Effectiveness Analysis.” Annals of Internal Medicine. 1993. Vol. 118, No. 4. Pages 298-306. R. Mulley AG, Silverstein MD, and Dienstag JL. “Indications for use of Hepatitis B Vaccine, Based on Cost-Effectiveness Analysis.” The New England Journal of Medicine. 1982. Vol. 307. Pages 644-652. S. Hillman AL, Blasco I, Bloom BS, and Schwartz JS. “Cost Effectiveness of Hepatitis B Immunization Strategies.” PharmacoEconomics. 1994. Vol. 5, No. 2. Pages 85-87. T. Krahn M and Detsky AS. “Should Canada and the United States Universally Vaccinate Infants against Hepatitis B?” Medical Decision Making. 1993. Vol. 13, No. 1. Pages 4-20. U. Chang MH, Chen CJ, Lai MS, Hsu HM, et al. “Universal Hepatitis B Vaccination in Taiwan and the Incidence of Hepatocellular Carcinoma in Children.” The New England Journal of Medicine. 1997. Vol. 336, No. 26. Pages 1855-1859. V. Zuckerman AJ. “Prevention of Primary Liver Cancer by Immunization.” The New England Journal of Medicine. 1997. Vol. 336, No. 26. Pages 1906-1907. W. Mayor S. “Liver cancer in Taiwan falls after universal hepatitis B vaccination.” BMJ. 1997. Vol. 315. X. Chen DS. “Hepatitis B Vaccines: Status Report on Long-Term Efficacy.” Abstract. IX Triennial International Symposium on Viral Hepatitis and Liver Disease. Rome, Italy. April 1996. Y. Harrison TJ, Chen JY, and Zuckerman AJ. “Hepatitis B and primary liver cancer.” Cancer Treatment Reviews. 1986. Vol. 13. Pages 1-16. Z. Tsai JF, Chang WY, Jeng JE, Ho MS, Lin ZY, and Tsai JH. “Hepatitis B and C virus infection as risk factors for liver cirrhosis and cirrhotic hepatocellular carcinoma: a case-control study.” Liver. 1994. Vol. 14. Pages 98-102. AA. Yu MW, Hsu FC, Chu CM, Lin DY, Chen CJ, and Liaw YF. “Prospective Study of Heptatocellular Carcinoma and Liver Cirrhosis in Asymptomatic Chronic Hepatitis B Virus Carriers.” American Journal of Epidemiology. 1997. Vol. 145, No. 11. Pages 1039-1047. BB. Blumberg. “Hepatitis B virus, the vaccine, and the control of primary cancer of the liver.” Proc. Nat. Acad. Sci. 1997. Vol. 94. Pages 7121-7125. CC. Morio S, Okamoto N, Minowa M, Mori H, and Nishioka K. “Preventive Effect of HB Vaccination against Liver Cancer: an estimation by Simulation.” Jpn. J. Cancer Res. 1987. Vol. 87, Pages 899-907. DD. “Worldwide Immunization Program Targets Hepatitis B and Liver Cancer.” Journal of the National Cancer Institute.” 1991. Vol. 83, No. 10. EE. Jin OC. “Liver Cancer in Singapore: An Overview.” Singapore Med. J. 1987. Vol. 28, No. 5. Pages 410-414. FF. Shu-Sheng W, et al. “Vaccination Against Hepatitis B in Long An County, a Hyperendemic Area of Primary Liver Cancer.” Abstract. GG. Zhu K, Levine RS, Brann EA, and Brann MK. “The Relationship of Hepatitis History and Pathological Diagnosis of Primary Liver Cancer.” J Clin Epidemiol. 1997. Vol. 50, No. 3. Pages 297-301. HH. World Health Organization. “Hepatitis B Vaccine set for Introduction into National Immunization Programmes.” Press Release WHO/12. February 1992. II. Okada S, et al. “Past Exposure to Hepatitis B Virus (HBV) as a Risk Factor for Hepatocellular Carcinoma (HCC) in Japanese Liver Patients with Chronic Liver Disease (CLD): A Case-Control Study.” Abstract. JJ. 4 Memos on Hepatitis B Vaccine. KK. “Immunization of Adolescents: Recommendations of the Advisory Committee on Immunization Practices, the American Academy of Pediatrics, the American Academy of Family Physicians, and the American Medical Association.” Morbidity and mortality Weekly Report. 1996. Vol. 45.

- 18 - LL. Brookman RR, Koff RS, Schaffner W, Margolis HS, Collins M, Bloom BS, and Coupey SM. “Critical Issues Surrounding Hepatitis B Vaccination for Adolescents: A Roundtable.” Journal of Adolescent Health. 1995. Vol. 17, No. 4. Pages 208-233. MM.Lawrence MH and Goldstein MA. “Hepatitis B Immunization in Adolescents.” Journal of Adolescent Health. 1995. Vol. 17, No. 4. Pages 234-243. NN. Sharfstein J and Wise PH. “Inadequate Hepatitis B Vaccination of Adolescents and Adults at an Urban Community Health Center.” Journal of the National Medical Association. 1997. Vol. 89, No. 2. Pages 86-92. OO. Mattey EA. “Hepatitis B Vaccine for School Staff at Risk.” Journal of School Nursing. 1997. Vol. 13, No. 1. Pages 4-8.

6. Thomas Jefferson University, Jefferson Medical College (Hie-Won L. Hann, M.D., Professor of Medicine and Director, Liver Disease Prevention Center) A. Letter supporting hepatitis B immunization.

7. The Insurance Federation of Pennsylvania (John R. Doubman, Secretary & Counsel) A. Letter addressing section 9 requirements.

8. Hepatitis Foundation International (Thelma King Thiel, Chairman and Chief Executive Officer) A. Letter supporting hepatitis B immunization. B. Numerous pamphlets and brochures on hepatitis.

9. Pennsylvania Department of Health (Gary L. Gurian, Deputy Secretary for Public Heath Programs) A. Letter describing several hepatitis B vaccination programs developed and supported by the Department of Health.

10. Fox Chase Cancer Center (W. Thomas London, M.D., Researcher) A. Letter supporting hepatitis B immunization.

11. Fox Chase Cancer Center (Baruch S. Blumberg, M.D., Ph.D., Researcher, Science Advisor to the Hepatitis B Foundation) A. Letter supporting hepatitis B immunization.

- 19 - i “Hepatitis B,” Hepatitis B Foundation, New Jersey. ii William Atkinson, MD, MPH, et al., “Hepatitis B.” Epidemiology and Prevention of Vaccine- Preventable Diseases, 2nd ed., Centers for Disease Control and Prevention, 1995, pp. 139-158. iii Craig Shapiro, MD, “Epidemiology of hepatitis B,” The Pediatric Infectious Disease Journal, Vol. 12, No. 5, 1993, pp. 433-437. iv William Atkinson, MD, MPH et al., “Hepatitis B.” Epidemiology and Prevention of Vaccine- Preventable Diseases, 2nd ed., Centers for Disease Control and Prevention, 1995, pp. 139-158 v William Atkinson, MD, MPH et al., “Hepatitis B.” Epidemiology and Prevention of Vaccine- Preventable Diseases, 2nd ed., Centers for Disease Control and Prevention, 1995, pp. 139-158 vi William Atkinson, MD, MPH et al., “Hepatitis B.” Epidemiology and Prevention of Vaccine- Preventable Diseases, 2nd ed., Centers for Disease Control and Prevention, 1995, pp. 139-158 vii “Someone You Know Has Hepatitis B,” Hepatitis B Foundation, Pennsylvania. viii Craig Shapiro, MD, “Epidemiology of hepatitis B,” The Pediatric Infectious Disease Journal, Vol. 12, No. 5, 1993, pp. 433-437. ix William Atkinson, MD, MPH et al., “Hepatitis B.” Epidemiology and Prevention of Vaccine- Preventable Diseases, 2nd ed., Centers for Disease Control and Prevention, 1995, pp. 139-158. x William Atkinson, MD, MPH et al., “Hepatitis B.” Epidemiology and Prevention of Vaccine- Preventable Diseases, 2nd ed., Centers for Disease Control and Prevention, 1995, pp. 139-158 xi Pierre Pare, MC, FRCPC, FACG, “The Clinical Consequences of Chronic Hepatitis B,” [email protected], Quebec, Canada, 1996. xii William Atkinson, MD, MPH et al., “Hepatitis B.” Epidemiology and Prevention of Vaccine- Preventable Diseases, 2nd ed., Centers for Disease Control and Prevention, 1995, pp. 139-158 xiii Raymond S. Koff, MD, FACP, “Hepatitis B today: clinical and diagnostic overview,” The Pediatric Infectious Disease Journal, Vol.12, No.5, 1993, pp. 428-432. xiv xv William Atkinson, MD, MPH et al., “Hepatitis B.” Epidemiology and Prevention of Vaccine- Preventable Diseases, 2nd ed., Centers for Disease Control and Prevention, 1995, pp. 139-158 xvi Samuel Lee, MD, FRCPC, “Hepatitis B: Questions and Answers,” [email protected], Quebec, Canada, 1997. xvii Karin Schumacher, “Hepatitis B Disease and Vaccine Facts,” National Vaccine Information Center, [email protected], Virginia, 1996-1997. xviii William Atkinson, MD, MPH et al., “Hepatitis B.” Epidemiology and Prevention of Vaccine- Preventable Diseases, 2nd ed., Centers for Disease Control and Prevention, 1995, pp. 139-158. xix F B Hollinger, “Comprehensive control (or elimination) of hepatitis B virus transmission in the United States,” Baylor College of Medicine, Houston, Texas, pp. S24-S30. xx Alan L. Hillman, MD, et al., “Cost Effectiveness of Hepatitis B Immunization Strategies,” Pharmaco Economics. Vol. 5, No. 2, 1994, pp. 85-87. xxi American School Health Association’s Resolution of Hepatitis B Immunization, 1994. xxii William Atkinson, MD, MPH et al., “Hepatitis B.” Epidemiology and Prevention of Vaccine- Preventable Diseases, 2nd ed., Centers for Disease Control and Prevention, 1995, pp. 139-158 xxiii F B Hollinger, “Comprehensive control (or elimination) of hepatitis B virus transmission in the United States,” Baylor College of Medicine, Houston, Texas, pp. S24-S30. xxiv Karin Schumacher, “Hepatitis B Disease and Vaccine Facts,” National Vaccine Information Center, [email protected], Virginia, 1996-1997. xxv “Hepatitis B Fact Sheet,” Centers for Disease Control and Prevention, www.cdc.gov, 1998.

- 20 - xxvi Pennsylvania Department of Health, Division of Statistics. xxvii Pennsylvania Department of Health, Prenatal Hepatitis B Program, www.health.state.pa.us, 1998. xxviii William Atkinson, MD, MPH et al., “Hepatitis B.” Epidemiology and Prevention of Vaccine- Preventable Diseases, 2nd ed., Centers for Disease Control and Prevention, 1995, pp. 139-158 xxix “Immunization of Adolescents: Recommendations of the Advisory Committee on Immunization Practices, the American Academy of Pediatrics, the American Academy of Family Physicians, and the American Medical Association, “ Morbidity and MortalityWeekly Report, Vol. 45, 1996. xxx F B Hollinger, “Comprehensive control (or elimination) of hepatitis B virus transmission in the United States,” Baylor College of Medicine, Houston, Texas, pp. S24-S30. xxxi F B Hollinger, “Comprehensive control (or elimination) of hepatitis B virus transmission in the United States,” Baylor College of Medicine, Houston, Texas, pp. S24-S30. xxxii Independent Insurance Agents of Pennsylvania, Letter from Vince Phillips, July 1998. xxxiii Highmark. Submission to the Health Care Cost Containment Council for Senate Bill 499. July 2, 1998. xxxiv F B Hollinger, “Comprehensive control (or elimination) of hepatitis B virus transmission in the United States,” Baylor College of Medicine, Houston, Texas, pp. S24-S30. xxxv Alan L. Hillman, MD, et al., “Cost Effectiveness of Hepatitis B Immunization Strategies,” Pharmaco Economics. Vol. 5, No. 2, 1994, pp. 85-87. xxxvi Immunization Practices Advisory Committee, “Hepatitis B: A Comprehensive Strategy for Eliminating Transmission in the United State Through Universal Childhood Vaccination,” Morbidity and Mortality Weekly Report, Vol. 40, 1991, pp. 1-25.

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