3-0900-15220-1

 

STATE OF MINNESOTA

OFFICE OF ADMINISTRATIVE HEARINGS

FOR THE MINNESOTA DEPARTMENT OF HEALTH

 

In the Matter of the Proposed

Rules Relating to Child Care                                                 REPORT OF THE

and School Immunizations,                               ADMINISTRATIVE LAW JUDGE

Minnesota Rules, Chapter 4604

 

Administrative Law Judge Kathleen D. Sheehy conducted a hearing concerning the above rules beginning at 9:00 a.m. on February 28, 2003, in the Mississippi Room of the Snelling Office Park building, 1645 Energy Park Drive, St. Paul, Minnesota.  The hearing continued until all interested persons, groups and associations had an opportunity to be heard concerning the proposed rules. 

           

The hearing and this Report are part of a rulemaking process governed by the Minnesota Administrative Procedure Act.[1]  The legislature has designed the rulemaking process to ensure that state agencies have met all of the requirements that Minnesota law specifies for adopting rules.  Those requirements include assurances that the proposed rules are necessary and reasonable, that they are within the agency’s statutory authority, and that any modifications that the agency may have made after the proposed rules were initially published are not impermissible substantial changes. 

 

          The rulemaking process includes a hearing when a sufficient number of persons request that a hearing be held.  The hearing is intended to allow the agency and the Administrative Law Judge reviewing the proposed rules to hear public comment regarding the impact of the proposed rules and what changes might be appropriate.  The Administrative Law Judge is employed by the Office of Administrative Hearings, an agency independent of the Department of Health (Department or MDH). 

 

          The Department was represented by a panel that included:  Patricia Segal Freeman, Policy Analyst; Kristen Ehresmann, Section Manager, Immunization, Tuberculosis and International Health Section within the Division of Infectious Disease, Epidemiology Prevention and Control; Harry Hull, State Epidemiologist and Director of the Division of Infectious Disease, Epidemiology, Prevention & Control; Catherine Lexau, Clinical Nurse Specialist and Director of the Pneumococcal Surveillance System; and Scott Giebink, Professor and Interim Chair of the Department of Pediatrics, University of Minnesota, and Chair of the MDH Immunization Practices Task Force.  Approximately seventy members of the public attended the hearing.  Forty-six people signed the hearing register.  Twenty-seven members of the public spoke at the hearing. 

 

The Office of Administrative Hearings received large numbers of written comments on the proposed rules before the hearing.  After the hearing, the record remained open for twenty calendar days, until March 20, 2003, to allow interested persons and the Department an opportunity to submit written comments.[2]  Following the initial comment period, the record remained open for an additional five business days to allow interested persons and the Department the opportunity to file a written response to the comments submitted.  The deadline for responses to the comments was March 27, 2003.  The OAH hearing record closed for all purposes on March 27, 2003.

 

The rulemaking record contains hundreds of written comments, as well as several videotapes and a book, from persons opposing and supporting the proposed rules.  The bulk of the comments were short expressions of opposition to or support for the proposed rules.  Some comments contained personal information about deaths, serious illnesses, or developmental disorders suffered by family members or patients; the commenters believed in some cases that these tragedies were caused by vaccinations, and in other cases the commenters believed they would have been prevented by vaccinations.  A minority of the written comments contained reference to scientific literature or provided data in support of their contentions.  All of the comments received were read and considered.

 

          This Report must be available for review to all interested persons upon request for at least five working days before the Department takes any further action on the proposed amendments.  The Department may then adopt a final rule, or modify or withdraw its proposed amendments.  When the rules are filed with the Secretary of State, the Department shall give notice on the day of filing to all persons who requested that they be informed of the filing.

SUMMARY OF CONCLUSIONS

          The Department has established that it has the statutory authority to adopt the proposed rules and that the rules are necessary and reasonable in all respects.

Based upon all the testimony, exhibits and written comments, the Administrative Law Judge makes the following:

 

FINDINGS OF FACT

 

Nature of the Proposed Rules

 

1.               This rulemaking proceeding involves modifications to the existing immunization schedule as well as additions to the schedule of immunizations for children in child care, grades K-12, and students at post-secondary institutions.  The most controversial of the proposed rules would add varicella (chickenpox) and pneumococcal conjugate vaccines to the schedule of immunizations.  The MDH believes these two new vaccinations will protect children and adults from contagious and infectious diseases.  Other and less controversial proposed rules concern administrative changes to the schedule or changes to the timing of vaccinations that are currently on the schedule.

 

Procedural Requirements of Chapter 14

 

2.       On July 1, 2002, the MDH published a Request For Comments on Possible Amendments to Rules Governing Child Care and School Immunizations at 27 State Register 30-31.[3]  Because the Department felt that these proposed rules would affect many different people, it solicited comments by:

 

• Mailing over 23,000 letters to health care providers, licensed child care homes and centers, schools, and other interested parties;

 

·       Sending the Request for Comments to thousands of people in different organizations through individual e-mails and listservs;

 

• Sending out a press release announcing the Request For Comments and a list of the public meetings to media outlets throughout the state on July 22, 2002;

 

• Developing a specific immunization rule web site to keep the public updated on the rule and the rulemaking process; and

 

• Developing a specific immunization rule e-mail address where the public could send their comments or questions on the rule.[4]

 

3.       MDH scheduled three public meetings concerning the proposed changes.[5]  The three meetings, on July 24, August 21, and September 17, 2002, were well-publicized and well-attended.

 

4.       On December 30, 2002, the proposed rule amendments and the Notice of Hearing were published at 27 State Register 1013-1016.[6]

 

5.       On December 31, 2002, the MDH mailed the Notice of Hearing to all persons and association who had registered their names with the agency for the purpose of receiving such notice and to all persons identified in the additional notice plan.[7]

 

6.     On the day of the hearing the following documents were placed in the record:

 

• The Request For Comments published in the State Register (Ex. A);

 

• A copy of the proposed rules with Revisor’s approval (Ex. C);

 

• A copy of the Statement of Need and Reasonableness (SONAR) (Ex. D), with

Attachments A - L;

 

• Certificate of Delivery of the SONAR to the Legislative Reference Library and

copy of transmittal letter (Ex. E);

 

• The Notice of Hearing as published in the State Register and mailed (Ex. F);

 

• Certificate of Mailing the Notice of Hearing and Certificate of Accuracy of the Mailing List (Ex. G);

 

• Certificate of Giving Additional Notice Pursuant to the Additional Notice Plan (Ex. H);

 

• Written comments on the proposed rules received during the comment period (Ex. I);

 

• Certificate of Sending the Notice of Hearing and SONAR to Legislators (Ex. K);

 

• Statutes cited for authority to adopt the proposed rules (Ex. L);

 

• Transcripts of public meetings held by MDH on July 24, August 21, and September 17, 2002 (Ex. M);

 

• Letters of Support from Minnesota Medical Organizations (Ex. N);

 

• Sabin Vaccine Report containing Open Letter on Vaccine Safety (Ex. O);

 

• MMWR publication entitled “Surveillance for Safety After Immunization: Vaccine

Adverse Event Reporting System (VAERS) – United States, 1991-2001 (Ex. P);

 

• Letter from Rep. Henry Waxman entitled “Update on Vaccine Safety” (Ex. Q);

 

• Photographs of children who have diseases targeted by vaccines (Ex. R);

 

• MDH Press Release entitled “Proposed changes in school immunization

requirements would add chickenpox, pneumococcal vaccines” (Ex. S);

 

• MDH document entitled “Responses to Issues Brought Up Since Publication

of the Hearing Notice for Proposed School Immunizations Rules” (Ex. T);

 

• MDH PowerPoint presentation for rules hearing (Ex. U); and

 

• Information from Vaccine Adverse Event Reporting System (VAERS) website

entitled “Guide to Interpreting Case Report Information Obtained from

[VAERS]” (Ex. V).

 

Additional Notice

 

7.       Minnesota Statutes, sections 14.131 and 14.23, require that the SONAR contain a description of MDH’s efforts to provide additional notice to persons who may be affected by the proposed rules.  MDH submitted an additional notice plan to the Office of Administrative Hearings, which reviewed and approved it by letter dated December 11, 2002.  The additional notice plan included notification to the following groups and individuals by the methods described:

 

• Mailing the summary letter describing the rules, changes made, date and time of hearing, address for sending comments, and methods of obtaining the rule and SONAR to health care providers, school officials, all licensed child care providers, and a representative of the Minnesota Natural Health Coalition.[8]

 

• Posting the proposed rules, the Notice of Hearing, the SONAR, and the summary letter on the immunization rule web site.

 

• Providing a copy of the summary letter, the proposed rules, and SONAR via e-mail, directly or through a listserv, to various organizations and individuals including:

 

o      Minnesota Immunization Practices Task Force

o      School Nurses Organization of Minnesota

o      Minnesota Nurses Association

o      Minnesota Medical Association

o      Minnesota Academy of Pediatrics

o      Minnesota Academy of Family Practice

o      National Association of Pediatric Nurse Practitioners

o      Physicians Assistant groups

o      Early childhood providers, including school readiness, ECFE, and screening coordinators

o      Immunization coalitions

o      Minnesota Council of Health Plans

o      A representative of the Minnesota Natural Health Coalition

o      Persons requesting rule notification from the three public meetings

 

• Publishing information such as notice of the proposed rules, a brief list of proposed changes, and where to obtain further information in MDH newsletters that reach affected parties.

 

Statutory Authorization

 

8.       The Minnesota School Immunization Law, Minn. Stat. § 121A.15, provides in general that before children more than two months of age may be enrolled in any child care facility or in an elementary or secondary school, their parent or guardian must submit a statement from a physician or public clinic stating that the person has received immunizations for measles after the age of 12 months, rubella, diphtheria, tetanus, pertussis, polio, mumps, haemophilus influenza type b (Hib), and hepatitis B; or that the person has received immunizations for measles after the age of 12 months, rubella, mumps, and Hib and has commenced a schedule of immunizations for diphtheria, tetanus, pertussis, polio, and hepatitis B.[9]  The primary schedule of immunizations for children less than seven years of age consists of four doses of vaccine for diphtheria, tetanus, and pertussis, and three doses of vaccine for polio and hepatitis B.  The primary schedule of immunizations for children older than seven years of age consists of three doses of vaccine for diphtheria, tetanus, polio, and hepatitis B.[10]

 

9.       The statute also provides that the person or a parent or guardian may submit a substitute statement (not from a physician or public clinic) that meets certain other criteria.[11]  Administrators of schools and child care facilities are required to report to the commissioner of children, families, and learning or the commissioner of human services, respectively, who in turn report to the commissioner of health: the number of persons enrolled, the number who have not been immunized, and the number who are exempt from immunization.[12]

 

10.     There are a number of exemptions to the immunization schedule, including exemptions for medical reasons.  In addition, a parent or guardian may submit a notarized statement providing that the child has not received immunizations because of the conscientiously held beliefs of the parent or guardian.[13]  In such a case, the specified immunizations are not required.

 

11.     Since its enactment in 1967, the School Immunization Law has been amended a number of times (five times in the last seven years) to add vaccines or to incorporate new scheduling or dose requirements. These amendments made the law consistent with the recommendations of the U.S. Public Health Service’s Advisory Committee on Immunization Practices (ACIP), the American Academy of Pediatrics (AAP), the American Academy of Family Physicians (AAFP), and the Department’s Health Immunization Practices Task Force.[14]  In 1989, the College Immunization Law, Minn. Stat. § 135A.14, was enacted.  It requires similar documentation from persons entering post-secondary schools.

 

12.     During the 2001 legislative session, MDH again put forth proposed changes to the School Immunization and College Immunization Laws to bring the statutes into conformance with the recommendations of the above groups.  At the end of the session the legislature amended the statutes to provide the Commissioner of Health with rulemaking authority and directed MDH to use its rulemaking authority to modify the immunization requirements.[15]  This process was intended to allow enough flexibility to ensure that school immunization requirements are kept up to date with current scientific research, medical practice standards, and vaccine developments, while at the same time ensuring the opportunity for public input.[16]   

 

13.     The statutes now provide, in identical language, that the commissioner of health may adopt modifications to the immunization requirements of sections 121A.15 and 135A.14.  A proposed modification must be part of the current immunization recommendations of each of the following organizations:  the ACIP, the AAFP, and the AAP.  In proposing a modification to the immunization schedule, the commissioner must:

 

(1)  consult with the commissioner of children, families, and learning; the commissioner of human services; the chancellor of the Minnesota state colleges and universities; and the president of the University of Minnesota; and

 

(2)  consider the following criteria:  the epidemiology of the disease, the morbidity and mortality rates for the disease, the safety and efficacy of the vaccine, the cost of a vaccination program, the cost of enforcing vaccination requirements, and a cost-benefit analysis of the vaccination.[17]

 

14.     The addition of the varicella and pneumococcal conjugate vaccines to the immunization schedule is consistent with the recommendations of the ACIP, the AAFP, and the AAP.[18]  The Department has met this requirement for the proposed rules.[19]

 

15.     In addition, MDH consulted with representatives of each of the required departments through an interagency immunization task force, which met for the first time on June 5, 2002.  MDH maintained contact with this group through e-mails and phone calls throughout the process.  The representatives of these agencies and institutions did not oppose the proposed changes to the immunization schedule.[20]  The MDH has met this requirement as well.

 

16.     The MDH has demonstrated in its SONAR, at the hearing, and in its responses to comments that it has considered the epidemiology of varicella[21] and pneumococcal disease,[22] the morbidity and mortality rates for the diseases, the safety and efficacy of the vaccines, the cost of a vaccination program, the cost of enforcing vaccination requirements, and a cost-benefit analysis of the vaccination.  The MDH has satisfied this statutory requirement.  The evidence supporting the Department’s compliance with this requirement is addressed more specifically in the rule-by-rule analysis below.   

 

17.     There are additional procedural steps involved in changing the immunization requirements.  Before a proposed modification may be adopted, the commissioner must notify the chairs of the house and senate committees with jurisdiction over health policy issues.  If the chairs of the relevant standing committees determine a public hearing regarding the proposed modifications is in order, the hearing must be scheduled within 60 days of receiving notice from the commissioner.  If a hearing is scheduled, the commissioner may not adopt any proposed modifications until after a hearing is held.[23]  MDH sent the required notice.[24]  The Senate Health and Family Security Policy Committee held a hearing on January 23, 2003, and the House Health and Human Services Policy Committee held a similar hearing on January 27, 2003.[25] 

 

18.     Finally, the commissioner must comply with the requirements of chapter 14 regarding the adoption of any proposed modifications to the immunization schedule,[26] and in addition to the publication requirements of chapter 14, must inform all immunization providers of any adopted modifications to the immunization schedule in a timely manner.[27]  MDH has committed to compliance with this requirement.  When the rules are deemed final and adopted, MDH promptly will send a mass mailing to all school districts and health care providers.  MDH also plans to notify affected parties through e-mail and available listservs, health publications, and other health web sites.[28]

 

          19.     The commissioner has the statutory authority to adopt the proposed rules.  Furthermore, the commissioner has demonstrated compliance with the procedural requirements of Minn. Stat. §§ 121A.15, subd. 12, and 135A.14, subd. 7.

 

Objections Relating to MDH Authority

 

          20.     The most frequently stated objection to the proposed rules (made by approximately 50 commenters) was that the government should not have the authority to require immunizations or that government should not intrude on health care decisions concerning immunizations, but that these decisions should be made solely by parents or by parents in consultation with physicians.  This objection is not properly directed to the Department.  The decision to establish an immunization schedule was made by the legislature, and the Department can only take action that is consistent with the relevant statutes.  The Department would have no authority, for example, to make changes to the schedule that are inconsistent with the recommendations of the ACIP, the AAFP, and the AAP.  The law itself contains an exemption provision that would permit any parent to file a statement documenting a conscientious objection to immunizations.  Even absent such a broad exemption provision, it was settled long ago that it is well within the police power of a state to provide for compulsory vaccination.[29]  These objections provide no legal basis for finding the proposed rules unnecessary or unreasonable.

 

          21.     Another large category of commenters believe that there is insufficient research on vaccine safety in general, maintaining that certain immunizations are or may be associated with a variety of health problems (MMR with autism, epilepsy, attention deficit hyperactivity disorder, and other neurological problems; Hib with diabetes or multiple sclerosis; DPT with atopy diseases such as asthma, dermatitis, and eczema).[30]  They argue that the decline in occurrence of disease that corresponds to the widespread use of immunizations is due not to the administration of vaccines, but to other advances in public health such as improved living standards, better nutrition, antibiotics, and other medical treatments.  Another category of commenters, many of whom are chiropractors, believe that multiple immunizations in childhood may cause immune dysfunction because exposure to too many antigens may overwhelm an infant’s immune system.[31]  The Department disagrees with these comments, maintaining that large-scale, controlled studies have found no evidence of a causal link between vaccinations and these serious health problems and that children must be given vaccinations at a young age because that is when they are most vulnerable to certain diseases.

 

22.     These objections are similarly misplaced and provide no basis for finding the proposed rules unnecessary or unreasonable.  The statute at present requires documentation of immunizations for measles, mumps, rubella, diphtheria, tetanus, pertussis, polio, Hib, and hepatitis B, unless immunizations are medically contraindicated or parents have filed an exemption statement.  The legislature has made the decision to place these immunizations on the schedule, and it also has made the decisions concerning timing and dosage.  To the extent that commenters object to these requirements, their comments must be addressed to the legislature.  The main issues in this rulemaking proceeding are whether to add varicella and pneumococcal conjugate vaccinations to the schedule.  Objections specific to those vaccinations will be addressed in the rule-by-rule analysis below.

 

23.     A smaller group of commenters argued that the research supporting the safety of vaccines is questionable because of financial conflicts of interest on the part of vaccine researchers and members of government panels that approve vaccines.  In addition, they argue that to the extent the pharmaceutical industry provides funds for vaccine safety research, researchers will not risk their careers by releasing negative findings.  The US Food and Drug Administration (FDA) Center for Biologics Evaluation and Research controls the vaccine licensing process, pursuant to authority from the Food, Drug, and Cosmetic Act and the Public Health Service Act.  When the FDA licenses a vaccine, organizations such as the ACIP, the AAFP, and AAP may consider incorporating it into the schedule of recommended immunizations.  As noted above, the Minnesota School Immunization Law and the College Immunization Law require that any modifications to the immunization schedule be consistent with the recommendations of these organizations.  The Department would have no authority to remove a recommended vaccine from the schedule even if it agreed with the substance of this argument, which it does not.

 

24.     One commenter maintained that the exemption provision itself is discriminatory because a statement documenting a parent’s conscientious objection to immunizations must be notarized, whereas there is no notarization requirement for those who choose to immunize their children.  The Department has proposed no change to this statutory requirement and is not required to defend it.[32]  The Administrative Law Judge notes, however, that although the two groups are treated differently under the statute, there is a rational basis for doing so, and the differing treatment is not based on impermissible factors such as race, sex, age, or marital status.  There is no legal basis for requiring the Department to modify the notarization requirement.

 

Regulatory Analysis

 

25.     The Administrative Procedure Act requires an agency adopting rules to consider six factors in its Statement of Need and Reasonableness.  The first factor requires:

 

(1)      A description of the classes of persons who probably will be affected by the proposed rule, including classes that will bear the costs of the proposed rule and classes that will benefit from the proposed rule.       

 

          The people who will be primarily affected by the rules are:

 

·       Children and adolescents, both immunized and unimmunized, who attend child care or elementary and secondary schools, and colleges;

 

·       Parents and guardians who will make the decision on whether or not to vaccinate their child;

 

·       Licensed child care providers as defined in Minnesota Statutes, Section 245A and Minn. Rules, chapters 9502 and 9503. Child care providers are required to verify immunization history and compliance when a child enrolls in their program and to exclude children not in compliance;

 

·       Elementary and secondary schools and colleges that are responsible for documenting a child’s immunization history when they enroll in kindergarten, seventh grade, college, or transfer from another school;

·       Health care providers who are responsible for educating parents about immunizations and providing the immunizations to their children;

 

·       Health care insurance companies and self-insured health care plans who pay for these immunizations in the private sector;

 

·       Public sector health clinics that provide immunizations; and

 

·       The general public and all visitors to the state.

 

           The Department states that the following persons will bear the costs of the proposed rules:

 

·       Children and parents/guardians. Parents/guardians who cannot afford immunizations for their children do not have to pay for them.  Immunizations are available to them through a federal program called Vaccines for Children (VFC), which is available through most clinics in Minnesota.

 

·       Child care facilities and schools. Under the new rules, child care facilities and schools will bear part of the administrative burden because they are responsible for enforcing additional immunization requirements.

 

·       Insurance companies and health plans. These companies bear the cost of vaccination. However, under the new rules, these companies should not see much if any increase in direct medical costs because they already cover the costs of the immunizations in the proposed new requirements.

 

·       Health care professionals.  Under the new rules, health care professionals will provide vaccinations to meet the requirements ofthe new rules and will need to keep up to date on all the required immunizations.  Most health care providers are already offering these immunizations in their practice.

 

         The Department states that the potential beneficiaries of these proposed rules include every child, adolescent, and adult who lives in Minnesota, and all visitors to the state:

 

·       Immunized children and their parents or guardians will benefit because the new rules will lower the incidence of chickenpox and pneumococcal disease.

 

·       Non-immunized children will benefit because of herd immunity. Herd immunity is the concept that immunizing the large percentage of children who can be vaccinated protects those who have not been or cannot be vaccinated from that disease and also those were immunized but failed to develop an immune response to the vaccine.

 

• The general adult population will benefit because there will be fewer outbreaks or cases of vaccine-preventable diseases.

 

• Society in general will benefit because there will be fewer deaths due to vaccine-preventable disease and lower medical treatment costs associated with these diseases.

 

(2)      The probable costs to the Agency and to and any other agency of the implementation and enforcement of the proposed rule and any anticipated effect on state revenues.

 

          MDH states that the probable cost to the agency for implementing the proposed rule revisions will be minimal. There will be one-time costs associated with the development and distribution of educational materials on the new rules to establish public awareness and inform health care providers, schools, and child care providers. These costs will be incorporated into other educational information MDH provides. Currently, the immunization program is almost all federally funded. The cost of the vaccination for uninsured or under-insured children is already covered through the federal government’s Vaccines for Children (VFC) Program. In addition, the program is already vaccinating many of these children with the new proposed vaccine requirements.

 

          MDH states that there should be no cost to any other state agency for the implementation and enforcement of the proposed rules.

 

MDH states that the proposed rule revisions will not affect state revenue. The federally funded Minnesota Vaccines for Children program, Minnesota Care, and Medicaid already recommend and pay for all ACIP recommended immunizations, including those in these proposed rules.

 

(3)      The determination of whether there are less costly methods or less intrusive methods for achieving the purpose of the proposed rule.

 

MDH considered other less costly methods for achieving the purpose of the proposed rules.  The least costly method would be to have no new or amended immunization requirements.  Based on the scientific evidence and national recommendations, however, MDH has concluded that these new requirements are necessary and reasonable and will save medical and societal costs in the long run.

 

Another option would be to have schools distribute educational materials about vaccinations, but not require proof of vaccinations.  This would not help the state achieve its goal (and the national goal) of 90 percent immunization rates by 2010.  MDH has found that immunization laws work to raise immunization rates to the level necessary to protect the community as a whole.

 

MDH also discussed not requiring certain immunizations in order to decrease the administrative burden on schools and child care facilities.  MDH concluded, however,  that the epidemiologic data describing the harmful effects of these specific diseases outweigh the additional administrative burden.

 

MDH considered less intrusive methods (the same methods considered to be less costly, as described above).   Based on the scientific evidence, however, MDH concluded that these proposed requirements are reasonable and necessary.  In addition, the Minnesota School Immunization Law allows parents and guardians who are conscientiously opposed to immunizations to seek a legal exemption for their children.

 

(4)      A description of any alternative methods for achieving the purpose of the proposed rule that were seriously considered by the agency and the reasons why they were rejected in favor of the proposed rule.

 

          MDH states that it considered not requiring any new immunizations and instead conducting a health education campaign to encourage parents and guardians to vaccinate their children. This was rejected because the state would not be able to reach the high immunization levels necessary to protect children and achieve herd immunity.

 

          (5)      The probable costs of complying with the proposed rules.

 

MDH states that child care facilities and elementary and secondary schools will be responsible for helping in the enforcement of these vaccination requirements. Health plans, insurers, and the federal Vaccine for Children (VFC) program cover the cost of the vaccination.

 

    The current cost of the varicella vaccine per dosage is $44.41 for the public sector and $54.61 for the private sector. The current cost of the pneumococcal conjugate vaccine is $46 per dose in the public sector and $58 per dose in the private sector.  Prevnar costs about $50 per dose, but four doses are recommended.[33]  Health plans, other insurers, and the VFC program already cover the costs of the vaccine. Therefore under the new rules, both the public and private sector payors should not see much, if any, increase in direct medical costs. In the long run, insurance companies and hospitals should save moneybecause severe disease and death due to chicken pox and pneumococcal disease will be reduced, thus lowering treatment costs.  MDH does not anticipate any net costs to the insurance companies when these savings are taken into account. The health plans have not submitted to MDH any documentation indicating new costs. Insurance companies already take the costs of these vaccines into account when they decide to cover them.[34]

 

Even though schools will need to assess one more vaccine (varicella, at kindergarten and seventh grade), MDH only expects schools to incur a minimal additional cost due to a variety of factors that will lower current and future costs, including development of the Minnesota Immunization Information Connection (MIIC), a computer database that will send reminder notices directly to parents or their health care providers.[35] 

 

The cost to most child care facilities should be minimal because they will check vaccine or disease history at the same time they check for all other vaccinations upon enrollment.  Child care facilities by law must also check a child’s vaccination history each time that child moves to a new class.

 

(6)      An assessment of any differences between the proposed rules and existing federal regulation and a specific analysis of the need and for and reasonableness of each difference.

 

          MDH states that there are no federal regulations regarding school and child care immunization laws.

 

Performance Based Rules

 

26.     The Administrative Procedure Act[36] also requires an agency to describe how it has considered and implemented the legislative policy supporting performance based regulatory systems.  A performance based rule is one that emphasizes superior achievement in meeting the agency’s regulatory objectives and maximum flexibility for the regulated party and the agency in meeting those goals.[37]

 

27.     MDH states that the objective of school immunization requirements is to protect the individual and community from death and illnesses associated with vaccine-preventable diseases.  If the proposed requirements become law, the state will see a reduction in death and illness from vaccine-preventable diseases.  True performance-based rules would set specific outcomes and leave the means of achieving those outcomes up to the provider.  This approach is impossible or impracticable for this proposed immunization rule.  Allowing too much flexibility in the timing of vaccinations would expose many children to vaccine-preventable disease.  Timely vaccination is essential to protect children and the community at large.

 

28.     Nonetheless, MDH points to the following parts of the proposed rule that provide flexibility to health care providers and parents and guardians.  First, all of the vaccination requirements provide for an exemption if there is a medical reason why the immunization should not be given, or if the parent's conscientiously held beliefs prohibit the immunization.  Second, proposed Part 4604.0300, subpart 2, would allow any vaccine dose administered four or fewer days before the minimum age required in law to be considered valid for purposes of the immunization law. Before this change, there was no flexibility in the timing of the required immunization.

 

Rulemaking Legal Standards

 

29.     Under Minn. Stat. § 14.14, subd. 2, and Minn. Rule 1400.2100, a determination must be made in a rulemaking proceeding as to whether the agency has established the need for and reasonableness of the proposed rule by an affirmative presentation of facts.  In support of a rule, an agency may rely on legislative facts, namely general facts concerning questions of law, policy and discretion, or it may simply rely on interpretation of a statute, or stated policy preferences.[38]  The MDH prepared a Statement of Need and Reasonableness in support of the proposed rules.  At the hearing, the MDH primarily relied upon the SONAR as its affirmative presentation of need and reasonableness for the proposed amendments.  The SONAR was supplemented by comments made by MDH representatives at the public hearing and in written post-hearing submissions.

 

30.     The question of whether a rule has been shown to be reasonable focuses on whether it has been shown to have a rational basis, or whether it is arbitrary, based upon the rulemaking record.  Minnesota case law has equated an unreasonable rule with an arbitrary rule.[39]  Arbitrary or unreasonable agency action is action without consideration and in disregard of the facts and circumstances of the case.[40]  A rule is generally found to be reasonable if it is rationally related to the end sought to be achieved by the governing statute.[41]  The Minnesota Supreme Court has further defined an agency’s burden in adopting rules by requiring it to “explain on what evidence it is relying and how the evidence connects rationally with the agency’s choice of action to be taken.”[42]  An agency is entitled to make choices between possible approaches as long as the choice made is rational.  Generally, it is not the proper role of the Administrative Law Judge to determine which policy alternative presents the “best” approach since this would invade the policy-making discretion of the agency.  The question is rather whether the choice made by the agency is one that a rational person could have made.[43]

 

31.     In addition to need and reasonableness, the Administrative Law Judge must also assess whether the rule adoption procedure was complied with, whether the rule grants undue discretion, whether the MDH has statutory authority to adopt the rule, whether the rule is unconstitutional or illegal, whether the rule constitutes an undue delegation of authority to another entity, or whether the proposed language is not a rule.[44]

 

Analysis of the Proposed Rules

 

General

 

32.     This report is limited to discussion of the portions of the proposed rules that received significant comment or otherwise need to be examined.  When rules are adequately supported by the SONAR or the MDH’s oral or written comments, a detailed discussion of the proposed rules is unnecessary.  The agency has demonstrated the need for and reasonableness of all rule provisions not specifically discussed in this report by an affirmative presentation of facts.  All provisions not specifically discussed are authorized by statute and there are no other problems that would prevent the adoption of the rules.

 

Discussion of Proposed Rules by Topic

 

4604.0100 – Scope and Effect.

 

          33.     This provision provides that the new rules modify the requirements of and supersede any conflicting provisions of Minnesota Statutes §§ 121A.15 and 135A.14.  This provision is consistent with the authority granted to the commissioner in § 121A.15, subd. 12, and § 135A.14, subd. 7.  It is unusual for the legislature to grant an agency the express authority to modify statutory requirements, and this rule acknowledges that authority.  The Department has demonstrated the need for and reasonableness of this rule.

 

4604.0200 – Definitions.

 

          34.     This rule adds definitions to terms used in the statute and the rules.  For example, subpart 2 clarifies that enrollment means the first day of attendance.  Subpart 4 provides that a provider can be a licensed physician, a registered physician assistant, or an advanced practice nurse.  The term is not otherwise defined in Minn. Stat. § 121A.15, subd. 9.  Subparts 3, 5, and 6 define varicella disease and varicella and pneumococcal vaccine.  Although the authorizing statute does not provide the Department with general rulemaking authority, the agency does have implied power to formulate necessary classifications and definitions within the designated area of its regulation.[45]  The rule is within the Department’s statutory authority to modify the immunization requirements, and the Department has demonstrated the need for and reasonableness of the rule.

 

4604.0250 – Physician and Provider Statements.

 

          35.     The statute as it is currently worded permits statements only from physicians or public clinics.[46]  This rule provides that a provider, which is defined by part 4604.0200, subpart 4, to include a registered physician assistant or advanced practice nurse, may provide a statement of compliance with the immunization schedule.  Physician assistants and advance practice nurses now have prescribing authority and can administer vaccinations pursuant to Minn. Stat. §§ 147A.09 and 148.235.  When the School Immunization Law was originally written, this authority did not exist.  The Department’s authority to modify immunization requirements reasonably extends to making a change of this nature.  The Department has demonstrated the need for and reasonableness of this rule.

 

4604.0300 – Schedule Changes.

 

          36.     As currently written, the statute allows a child to enroll in an elementary or secondary school with at least one dose of a multi-dose vaccine, as long as the child completes the series within 18 months from the date of enrollment.[47]  Subpart 1 of this rule would shorten the time period for completing a required vaccine series from 18 months to eight months.  The Department states that this change was requested by school nurses, administrators, and public health officials to make it easier to ensure compliance within a single school year.  The 18-month period will remain in effect for children in child care facilities.  The ACIP, AAFP, and AAP have no position on timing, but recommend only that a provider give the shots within the period allowed by law.[48]

 

37.     As currently written, the statute also requires that an immunization be given on or after a certain age, because immunization doses administered too early can lead to a less than favorable immune response and provide less protection against the disease.  This means that persons who receive an immunization even one day before the required minimum age have to be revaccinated because they are not in compliance with the law.  Subpart 2 of the rule provides that a vaccine dose administered four or fewer days before the minimum age required by law is considered timely.  This change is consistent with recommendations of the ACIP and the AAFP.

 

38.     The Department’s authority to modify immunization requirements reasonably extends to making changes of this nature.  The Department has demonstrated the need for and reasonableness of this rule.

 

4604.0400 – Immunization Documentation Record.

 

          39.     This proposed rule provides as follows:

 

To document a person’s immunization history as required under parts 4604.0100 to 4604.1000 and Minnesota Statutes, section 121A.15, all child care facilities and elementary and secondary schools must use the Department of Health’s official record form or a similar document, approved by the commissioner of health, that requests information about immunizations and includes statements for documenting medical or conscientious exemptions.

 

40.     This rule is intended to address criticisms of those opposed to vaccination requirements that some schools and child care facilities do not provide information about the exemption provisions or do not acknowledge that exemptions are permitted under the statute.[49]  During the hearing, the Department stated that the focus of the rule is to require schools and child care facilities to use forms that acknowledge the parent’s ability to invoke the exemption provision.[50]  School nurses commented that it is unclear whether the Department would require schools to transfer information from provider statements onto the required form, and the Department indicated it did not intend to require such duplication of effort.[51]

 

41.     The wording of the rule as presently formulated does not make this clear.  The Department may want to provide an additional sentence stating that use of the form would not be necessary if a provider submits a statement, or that a provider statement attached to the form would comply with this requirement.  Or, if the rule is aimed solely at effectuating the exemption provision, the Department could modify the language to clarify that the form must be provided to parents and used to document an exemption but is not otherwise required.  This is not a defect in the rule, but is simply a clarification that the Administrative Law Judge recommends to avoid confusion in the future.  Such a change would not render the rule substantially different from the one proposed.  The rule otherwise is within the Department’s authority to modify immunization requirements, and the Department has demonstrated that it is needed and reasonable.

 

4604.0500 – Haemophilus Influenzae Type B (Hib) Dose Requirement for Infants.

 

          42.     There are four different Hib vaccine products.  Three of them are administered in a four-dose series; the fourth is given in three doses.  With all of these products, children need fewer doses of the vaccine if they begin the series later than recommended (at two months of age) or fall behind.  Because of these scheduling complexities, the law was originally written to simply require evidence of one Hib dose with no age specified.  To reflect the correct requirement, the change recommended by rule requires documentation that the child has received at least one dose of vaccine for Hib at or after 12 months of age.  This change is consistent with the recommendations of the ACIP, the AAP, and the AAFP.[52]  This proposed rule is within the Department’s authority to modify immunization requirements, and the Department has demonstrated that it is needed and reasonable.

 

4604.0600 – Changes in Measles, Mumps, and Rubella Vaccine Requirements.

 

          43.     As currently written, the statute requires that a person enrolled in grades seven through twelve show documentation of receipt of the second dose of vaccine against measles, mumps, and rubella.[53]  Beginning with the 2004-05 school year, the proposed change would require children to receive their second dose before entering kindergarten.  This change is consistent with the current recommendations of the ACIP, the AAFP, and the AAP.[54]  This change is within the Department’s authority to modify immunization requirements, and the Department has shown it to be necessary and reasonable.

 

4604.0700 – Suspension of School Immunization Laws

 

          44.     As currently written, the statute allows the commissioner of health to suspend a school immunization requirement for one year if an immunization is not necessary to protect public health.[55]  In recent years, there have been other reasons to take such action.  For example, a recent nationwide vaccine shortage left providers unable to administer all of the vaccines on the schedule.[56]  The Department has no desire to deny children enrollment in school when it is not possible to comply with the immunization schedule.  The proposed rule would give the commissioner authority to suspend immunization requirements if the commissioner determines that suspension is necessary to address a vaccine shortage or other emergency situation statewide or in a portion of the state.  In making such a determination the commission is required to consider the availability of the vaccine, the inability to comply with the law due to a natural or man-made disaster, or the ability to fulfill the commissioner’s general duties under Minn. Stat. § 144.05.  The rule would allow the commissioner to suspend a requirement for the length of time needed to remedy the vaccine shortage or emergency situation and provides for certain publication requirements for any suspension.

 

          45.     This change is within the Department’s authority to modify immunization requirements.  The Department has demonstrated that it is needed and reasonable.

 

4604.0800 – Hepatitis B Dose Requirement.

 

          46.     As currently written, the statute requires a child to receive three doses of hepatitis B vaccine.[57]  When this requirement was incorporated, the vaccine was only available in a three-dose series.  There is now a licensed two-dose product for children ages 11 through 15.  The proposed rule clarifies that a hepatitis B vaccine licensed and administered according to the alternative dosing schedule meets the statutory requirements.  The change is consistent with the recommendations of the ACIP, AAFP, and AAP.[58]  This change is within the Department’s authority to modify immunization requirements.  It is also needed and reasonable.

 

4604.0900 -- New Varicella (Chicken Pox) Vaccine Requirement.

 

          47.     Until now, Minnesota has recommended but not required vaccination against varicella.[59]  In this rule the Department proposes to add the varicella vaccine to the schedule of immunizations.  The rule would require children 18 months of age or older who enroll in a child care facility or students entering kindergarten or seventh grade to submit documentation of either receipt of the vaccine, history of the disease, or an exemption statement as permitted by statute.  The proposed change is consistent with the recommendations of the ACIP, the AAFP, and the AAP.[60] 

 

          48.     Before modifying the immunization schedule, the Department must consider the following criteria:  the epidemiology of the disease, the morbidity and mortality rates for the disease, the safety and efficacy of the vaccine, the cost of the vaccination program, and a cost-benefit analysis of the vaccination.[61] 

 

49.     Epidemiology of Varicella Disease.  Varicella disease (chicken pox) occurs worldwide and is caused by the varicella-zoster virus.  It is highly contagious.  It spreads by direct contact with secretions such as saliva or through the air from sneezing or coughing.  The rash begins as red bumps that turn into blisters and cover the entire body.  There are usually as many as 300 to 500 blisters during a single infection.  The incubation period is normally 14 to 16 days from exposure.  The clinical course in normal children is generally mild, with itching and fever up to 102 degrees for two to three days.  Ninety percent of household members catch the disease.  Among household members, those who are exposed to the first case and subsequently develop chickenpox get a more severe case of the disease than the first case.

 

50.     The most serious common complications of varicella disease include pneumonia, Group A streptococcal cellulitis (“flesh-eating” bacterial skin infections) and encephalitis (brain infections).  About one of every thousand children infected with chickenpox will develop severe pneumonia or encephalitis.  Infections with staph or streptococcus are the most common cause of hospitalization and outpatient medical visits.  The incidence of flesh-eating streptococcal disease as a complication of chicken pox has increased because of resistance to antibiotics.  Otherwise healthy children who receive intermittent courses of corticosteroids for treatment of asthma and other illnesses are more susceptible to severe complications and death due to chicken pox.  Adults are ten to 20 times more susceptible to severe complications and death from chicken pox than are children.  About one out of every 50 women infected with varicella during pregnancy will deliver children with birth defects, including mental retardation and shortened or atrophied limbs. 

 

51.     Morbidity and Mortality Rates for the Disease.   During the five years before the varicella vaccine was available, approximately 4 million cases of chicken pox occurred every year in the U.S., 85% of which occurred in children under 15 years of age.  An average of 11,000 hospitalizations and 100 deaths (40% in children) occurred annually.  In the 25 years before vaccine licensure in the U.S. in 1995, 2,263 deaths were attributed to chicken pox.  Most who died were previously healthy. 

 

          52.     Because chicken pox is often a mild disease, many commenters questioned the need for the varicella vaccination and objected to the inclusion of varicella vaccine on the immunization schedule.[62]  The Department maintains that although often mild, varicella is not a benign disease because the complications are potentially severe or fatal.  Furthermore, the Department maintains that failure to require the vaccination in childhood will actually cause an increase in the number of adults susceptible to the disease, because their chances of catching it as children are reduced, and that as adults these persons will face the much higher risk of severe complications or death.[63]  The Department estimates that if vaccine coverage exceeds 90%, cases of varicella disease will decrease for adults and children because of herd immunity.  Vaccination rates of less than 90% will not create herd immunity.

 

          53.     Some commenters have attempted to bootstrap arguments concerning the safety of other vaccines, such as those for measles or pertussis, into the discussion of the rules concerning varicella and pneumococcal conjugate vaccines, by arguing that until all questions about the safety of all vaccines have been resolved, no new vaccines should be added to the schedule.  In a similar vein, some commenters argue that until more research is done on vaccine safety in general, there can be no truly informed consent to any immunizations.[64]  As noted above, those other vaccines are currently on the schedule.  The Department is not required to defend the science behind vaccine safety in general every time it proposes to add a vaccine to the schedule.  The focus of this proceeding is properly on the epidemiology of varicella and pneumococcal disease, the morbidity and mortality rates for the diseases, the safety and efficacy of the proposed vaccines, the cost of a vaccination program, the cost of enforcing vaccination requirements, and a cost-benefit analysis of the vaccination at issue.

 

54.     Other comments were addressed to the efficacy of the Vaccine Adverse Event Reporting System (VAERS) as a mechanism for monitoring post-licensure safety.  VAERS was created as an outgrowth of the National Childhood Vaccine Injury Act of 1986 and is administered by the FDA and the CDC.  VAERS accepts reports of adverse events that follow the administration of all U.S.-licensed vaccines. Health care providers, manufacturers, and members of the public may submit a report.  The FDA monitors VAERS reports for unexpected patterns or changes in rates of adverse events, as does the CDC.  VAERS is a passive system, in that reporting is voluntary and consequently the number of events reported is likely smaller than the actual events that occur.[65]  Some commenters believe that this system is inadequate and that the Department accordingly cannot demonstrate that it is necessary and reasonable to add either the varicella or pneumococcal conjugate vaccines to the schedule.  Despite this limitation, the Department believes that the national scope and open-ended format of VAERS can and does reveal potential vaccine safety problems with new vaccines, citing the FDA’s recall of the rotavirus vaccine based in part upon receipt of VAERS reports. The Department also cites to data from the CDC concluding that although non-serious events may be underreported, the CDC believes that serious adverse events are likely to be reported to VAERS.  This is another area, subject to federal control, that the Department is not required to defend when proposing to add vaccines to the immunization schedule.  The proper focus is on the safety of the vaccines at issue.

 

55.     The Safety and Efficacy of Varicella Vaccine.  Varivax, the varicella vaccine, was licensed in 1995 after 16 years of study.  It is a live virus vaccine that causes a latent infection similar to that caused by the wild varicella virus.  Most common adverse reactions to the vaccine are injection site complaints, such as pain, soreness, redness, and swelling.  Approximately 3% of children and 1% of adolescents report a varicella-like rash at the injection site.  The Department points to several studies indicating that the risks from the vaccine are much lower than the risk from disease.[66]

 

56.     Regarding the efficacy of the vaccine, the Department points to data from the Centers for Disease Control (CDC) indicating that eight to nine out of every ten people vaccinated are completely protected from the disease.  Post-licensure studies in outbreak, community, and clinical settings have found vaccine effectiveness estimates ranging from 71% to 86%.  Since introduction of the vaccine in 1995, the number of cases of chicken pox has declined dramatically, along with associated hospitalizations.[67]  Although chicken pox is not a reportable disease in Minnesota, the Department has some data on hospitalizations between 1995 and 2000.  Based on a study of hospitals voluntarily reporting inpatient visits, the numbers declined from 48 per 100,000 hospitalizations in 1995 to 21 per 100,000 hospitalizations in 2000.  As of 2001, there has been an 80% decline in hospitalizations for varicella complications.  Deaths dropped from 50 per year to 8 per year in 2000.[68]  The Department maintains that varicella vaccine is the most effective strategy for protecting children and adults from illness and death due to chicken pox. 

 

57.     Some commenters contend that the vaccine is not sufficiently effective.  One recent study found the vaccine effective against 44% of all disease and 86% of moderate to severe disease.  It also found increased risk of vaccine failure among children vaccinated three or more years previously, suggesting that a booster dose may be needed to preserve immunity over time.  In response, the Department points out that  the same study showed that effectiveness rates were higher (85% to 90%) in children ages 2 to 12 and that the vaccine almost always prevents against severe disease in children; those who contract the disease after vaccination typically have mild cases with low-grade or no fever, fewer than 50 skin lesions, a shorter illness, and decreased chance of hospitalization compared to those with natural infection who were not immunized.[69]  The Department will continue to monitor post-licensure studies, and if the ACIP, AAFP, and AAP ultimately recommend a booster dose the Department will take action to modify the schedule to require it.

 

58.     Commenters also objected to the vaccination based on their belief that immunity resulting from exposure to the wild virus is more effective than that resulting from the vaccine, and that the vaccine consequently will increase the risk of shingles in adults.  The Department disagrees with the claim that infection with the wild virus provides more effective immunity than the vaccine, pointing to a study suggesting that the rate of recurrence after having the wild virus is as high as 13%, and that second infections were average or severe cases of disease.  Furthermore, the wild virus is capable of remaining in a dormant state in human tissue and may reactivate in approximately 15% of infected persons, resulting in shingles.  The Department points to data showing that the vaccine may actually protect against cases of shingles later in life, based on a study estimating the rate of shingles in vaccinated children to be 18 cases per 100,000, as opposed to 77 cases per 100,000 for persons infected with the wild virus.

 

59.     Cost Issues.  The Department maintains that the cost of the vaccine and the costs of administering the program are greatly outweighed by the reduction in hospital expenses (the median charge for a hospital stay for a person with chicken pox in 2000 was $6,206) and the societal benefits created by herd immunity.  In the Department’s view, vaccinating an individual child benefits both the individual and the larger community.  Persons who are not able to receive the vaccine for medical reasons can be protected only with a high level of vaccination coverage in the community.  The Department thoroughly considered cost issues and the reasons why alternative methods, such as community education, were not acceptable.[70]  No person objected to the vaccine based on its cost. 

 

60.     The Department has considered all the statutory criteria in considering whether to modify the immunization schedule to add the varicella vaccine.  Furthermore, the Department has thoroughly considered all arguments opposing the addition of varicella vaccine to the schedule.  The Department has concluded that an increase in the coverage rate is necessary to prevent outbreaks in older children, adolescents, and young adults.  It has also concluded that an increase in the coverage rate will protect against serious complications, especially given the increase in drug-resistant bacteria.  The Department’s decision to propose this change is not arbitrary or unreasonable based on the rulemaking record.  It is rationally related to the goal of reducing disease and disease complications.  It is not the role of the Administrative Law Judge to determine which policy alternative is best; the question is rather whether the choice made by the agency is one that a rational person could have made.  It clearly is.  The proposed rule is within the agency’s statutory authority, and the Administrative Law Judge finds that the MDH has demonstrated both the need for and reasonableness of the varicella vaccination rule.  

 

4604.1000, subparts 1 -- New Pneumococcal Vaccine Requirement for Child Care Enrollees.

 

61.     Until now, the Department has recommended but not required the vaccine for pneumococcal disease.  In this rule the Department proposes to add the pneumococcal conjugate vaccine to the schedule of immunizations.  The rule would require children between two months and two years of age who are in child care to document receipt of the pneumococcal vaccine or an appropriate exemption.[71]  The proposed change is consistent with the recommendations of the ACIP, the AAFP, and the AAP.[72] 

 

62.     Epidemiology of Pneumococcal Disease.  Pneumococcal disease is an infection due to the bacteria Streptococcus pneumoniae.  It is a common bacterial infection in infants and children in the United States.  It is the leading cause of bacterial meningitis, and a major cause of bacteraemia (blood stream infection), bacterial pneumonia, and ear infections.  Pneumococcal bacteria live in the lining of the nose and back of the throat.  Forty to 60% of children are carriers of the bacteria without coming down with the disease.  The bacteria are spread from direct contact with secretions from the nose, mouth, and throat (in other words, coughing and sneezing), which accounts for the prevalence of the disease in child care settings  Children with pneumococcal meningitis may have long term problems such as hearing loss and mental retardation.  Adult pneumococcal disease is one of the major causes of death in the very elderly.[73]

 

63.     In addition, treating pneumococcal disease with antibiotics has become more difficult because of increased antibiotic resistance in the bacteria.  This means that stronger, more expensive antibiotics with more side effects must be used.  In the Minneapolis-St. Paul metropolitan area, the percent of pneumococcal isolates from serious infections with resistance to penicillin rose from 14% in 1996 to 27% in 2000.  In children younger than five years of age, the percent of isolates with resistance to penicillin rose from 15% to 35% over the same time period.[74]

 

          64.     Morbidity and Mortality Rates of the Disease.  Each year in the United States, pneumococcal disease accounts for an estimated 1,400 cases of bacterial meningitis, 17,000 cases of bacteraemia, and more than 70,000 cases of pneumonia in children younger than five years of age.  An estimated 200 children die each year from the disease.  The highest rates of the disease occur in children under age 2 because they have underdeveloped immune systems.  In 1998, the estimated incidence in the United States of serious pneumococcal infections in children less than 12 months old was 106 cases/100,000, and for children 12 to 23 months it was 203 cases/100,000.  In contrast, incidence rates among persons of all ages were 24 cases/100,000.  For children who develop severe pneumococcal infections and complications, as many as three of every ten will die.  Severely ill children who survive the disease will suffer permanent effects of the infection 25% to 35% of the time, including hearing loss, seizures, or other forms of brain damage.[75]

 

          65.     Many commenters contended that the vaccine is unnecessary because pneumococcal disease is rare unless children have risk factors, such as immune system disorders.  The Department disagrees and has provided evidence that pneumococcal disease is widespread among children in the form of ear infections, bronchitis, sinus infections, and pneumonia.  Because pneumococcal infections are so common, the Department has monitored only the most serious of them, in which the bacteria have invaded the bloodstream or spinal fluid, causing meningitis.[76] 

 

66.     Safety and Efficacy of the Vaccine.  In 2000 the FDA licensed Prevnar, the pneumococcal conjugate vaccine, for use in young children.  The vaccine contains serotypes that cause 80% of the most severe pneumococcal disease.  A pre-licensure study of Prevnar between 1995-1998 found that the most common systemic reactions to the vaccine, when administered with other concurrent vaccines, were fever, irritability, drowsiness, decreased appetite, diarrhea, and rash.  Some tenderness and swelling occurred at the injection site in 10% to 15% of children.  Since the vaccine was licensed, studies have shown dramatic decreases in the rates of meningitis and other pneumococcal infections.[77]  The Department maintains that the vaccine has also helped reduce antibiotic resistance by reducing the number of cases of infection due to antibiotic resistant strains.  Researchers have found efficacy rates of 94% to 97% in children who have received some or all of the recommended doses.  In the largest study of the vaccine, it proved so effective that evaluators recommended termination of the trial midway through the study so that all children in the study, including those in the control group, could receive it.[78]  In Minnesota, the incidence rate of severe pneumococcal disease for children under two years of age has declined from 208 cases/100,000 in 1996-99 to 62.5 cases/100,000 in 2001.  These numbers likely underestimate the decline because invasive pneumococcal disease was not reportable state-wide until 2002.

 

67.     Some commenters were concerned about the aluminum content of the pneumococcal conjugate vaccine, maintaining that aluminum is a neurotoxin that may cause brain damage.  Many vaccines licensed by the FDA contain aluminum in the form of aluminum phosphate.  The FDA’s regulations limit the amount of aluminum in biological products, including vaccines, to 0.85 mg per dose.  Prevnar contains 0.125 mg per 0.5 ml of aluminum, well within the limits set by the FDA.[79]   

 

68.     Other commenters criticize the study referred to above, in which evaluators recommended termination of the trial based on the effectiveness of the vaccine.  They maintain that the vaccine should not be mandated until longer-term safety and efficacy studies are performed.  The Department maintains that it would have been unethical to deprive the control-group children in the study of a vaccine found to be both highly effective and safe.  The Department also has rejected commenters' criticisms of the study suggesting that the results are not valid because the vaccine’s manufacturer provided some of the funding.  The health plan that conducted the study was one of the largest HMOs in the country.  Recommending a vaccine that is not effective would increase HMO costs in the long run, by requiring HMOs to pay not only for the vaccine but also the costs of treating the disease.

 

69.     Cost-Effectiveness of the Vaccine.  The Department points to studies demonstrating that the up-front cost of the vaccine is outweighed by the costs of treating the disease and its complications.  One study predicted that, if fully implemented in the U.S., routine vaccination of healthy infants would prevent more than 12,000 cases of meningitis and bacteraemia, 53,000 cases of pneumonia, and one million ear infections, with a reduction in direct medical costs and other costs, including work loss, of almost $760 million.  In addition, the indirect benefits of the vaccine include reduction in the number of required diagnostic tests, reduction in antibiotic prescriptions, and reduction in the proportion of infections caused by antibiotic-resistant strains of the disease. 

 

70.     The Department has considered all the statutory criteria in considering whether to modify the immunization schedule to add the pneumococcal conjugate vaccine.  Furthermore, the Department has thoroughly considered all arguments opposing the addition of the vaccine to the schedule.  The Department has presented evidence that the vaccine is highly effective, very safe, and will reduce the problems associated with drug-resistant bacteria.  The Department’s decision to propose this change to the rules is not arbitrary or unreasonable based on the rulemaking record.  It is rationally related to the goal of reducing disease and disease complication.  It is not the role of the Administrative Law Judge to determine which policy alternative is best; the question is rather whether the choice made by the agency is one that a rational person could have made.  Again, it clearly is.  The proposed rule is within the agency’s statutory authority, and the Administrative Law Judge finds that the MDH has demonstrated both the need for and reasonableness of the rule requiring vaccination for pneumococcal disease.  

 

          Based upon the foregoing Findings of Fact, the Administrative Law Judge makes the following:

 

CONCLUSIONS

 

           1.      The MDH gave proper notice of the hearings in this matter.

 

2.       The MDH has fulfilled the procedural requirements of Minn. Stat. §§ 14.14, subds. 1, 1a, 1b and 14.14, subds. 2 and 2a, and all other procedural requirements of law or rule.

 

3.       The MDH has demonstrated its statutory authority to adopt the proposed rules and has fulfilled all other substantive requirements of law or rule within the meaning of Minn. Stat. §§ 14.05, subd. 1, 14.15, subd. 3 and 14.50 (i) and (ii).

 

4.       The MDH has documented the need for and reasonableness of its proposed immunization rules with an affirmative presentation of facts in the record within the meaning of Minn. Stat. §§ 14.14, subd. 2 and 14.50 (iii). 

 

5.       The MDH has not proposed any amendments and additions to the proposed rules.

 

6.       Any Findings that might properly be termed Conclusions and any Conclusions that might properly be termed Findings are hereby adopted as such.

 

7.       A finding or conclusion of need and reasonableness in regard to any particular rule subsection does not preclude and should not discourage the MDH from further modification of the proposed rules based upon an examination of the public comments, provided that the rule finally adopted is based upon facts appearing in this rule hearing record.

           

Based upon the foregoing Conclusions, the Administrative Law Judge makes the following:

 

RECOMMENDATION

 

            IT IS HEREBY RECOMMENDED that the proposed rule amendments be adopted.

 

Dated this 29^th day of April, 2003.

KATHLEEN D. SHEEHY

Administrative Law Judge

 

Reported:  Court Reporter,

Transcript Prepared.