Staff Summary | House Bill 1873 - Hepatitis B Immunization | Mandated Benefits Review

Mandated Benefits Review - HB 1873 Staff Summary of the Documentation Submitted
(in response to the eight requirements of Act 34, Section 9)

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 (4^th through 12^th 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."

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.

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 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.

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 19^th birthday, with over half of that infected at birth."

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."

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 6^th and 11^th 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 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."

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." 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."
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.
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.

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."

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.

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.

The results of any relevant research.

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

Evidence of the financial impact of the proposed legislation, including at least:
1. 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.
2. 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.
3. 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 (4^th to 12^th 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."
4. 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.
5. 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.
6. 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 4^th to 12^th against the hepatitis B virus would be a one-time expense. Those children entering kindergarten and 1^st 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 4^th through 12^th) 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).

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 6^th and 11^th 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." 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.

Mandated Benefits Review - HB 1873 Staff Summary of the Documentation Submitted(in response to the eight requirements of Act 34, Section 9)