Subchapter L. CHILDHOOD IMMUNIZATION
INSURANCE
Sec.
89.801. Authority and purpose; implementation.
89.802. Definitions.
89.803. Provision for coverage in policy.
89.804. Delivery of policy.
89.805. Cost-sharing provisions in policy.
89.806. Coverage of child immunizations.
89.807. Immunizing agents, doses and AWPs.
89.808. Filing requirements.
89.809. Exempt policies.
Authority The provisions of this Subchapter L issued under the Childhood Immunization Insurance Act (40 P. S. § § 3501—3508), unless otherwise noted.
Source The provisions of this Subchapter L adopted February 3, 1995, effective February 4, 1995, 25 Pa.B. 511, unless otherwise noted.
§ 89.801. Authority and purpose; implementation.
(a) Authority and purpose. This subchapter is jointly promulgated by the Departments to implement the act under section 7 of the act (40 P. S. § 3507).
(b) Implementation. The Department has primary responsibility for the interpretation and implementation of § § 89.803—89.805, 89.808 and 89.809. The Department of Health has primary responsibility for the interpretation and implementation of § § 89.806 and 89.807 (relating to coverage of child immunizations; and immunizing agents, doses and AWPs).
§ 89.802. Definitions.
The following words and terms, when used in this subchapter, have the following meanings, unless the context clearly indicates otherwise:
ACIP—The Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention, United States Department of Health and Human Services.
AWP—Average wholesale price.
Act—The Childhood Immunization Insurance Act (40 P. S. § § 3501—3508).
Child—An individual covered under a health insurance policy who is either the insured and under 21 years of age, or the insured’s spouse and under 21 years of age, or a dependent child pursuant to the definitions of the policy.
Child immunization—The immunization of a child, in accordance with § 89.806 (relating to coverage of child immunizations). The immunization will be reimbursed at the rate of the cost of the immunization up to 150% of the AWP of the immunizing agent.
Departments—The Department of Health and the Insurance Department.
Health insurance policy—Except for specified disease policies, a group health insurance policy, contract or plan, or an individual policy, contract or plan with dependent coverage for children, which provides medical coverage on an expense-incurred, service or prepaid basis. The term includes the following:(i) A health insurance policy or contract issued by a nonprofit corporation subject to 40 Pa.C.S. Chapters 61, 63 and 65 (relating to hospital plan corporations; professional health services plan corporations; and fraternal benefit societies).
(ii) A health service plan operating under the Health Maintenance Organization Act (40 P. S. § § 1551—1568).
(iii) A health insurance policy, contract or plan issued by or to an entity not exempt from Pennsylvania law by virtue of the Employee Retirement Income Security Act of 1974 (ERISA) (Pub. L. No. 93-406, 88 Stat. 829), including multiple employer welfare arrangements, as defined in section 3(40)(A) of that act (29 U.S.C.A. § 1002(40)(A)).
Immunization—The immunizing agent, as well as, its storage and its administration by a person authorized by law to administer an immunizing agent, and a procedure or material associated with the process of immunizing with the exception of a procedure or material employed due to a medical complication such as an adverse reaction to the immunizing agent.
Immunizing agent—An antigenic substance such as a vaccine or toxoid, or an antibody-containing preparation such as a globulin or antitoxin, when used to actively or passively immunize.
MMWR—The Morbidity and Mortality Weekly Report published by the Centers for Disease Control and Prevention, United States Department of Health and Human Services.§ 89.803. Provision for coverage in policy.
A health insurance policy which is not exempt from this subchapter under § 89.809 (relating to exempt policies) and which is delivered, issued for delivery, renewed, extended or modified in this Commonwealth on or after November 22, 1992, shall include coverage for child immunizations.
Cross References This section cited in 31 Pa. Code § 89.801 (relating to authority and purpose; implementation).
§ 89.804. Delivery of policy.
If a health insurance policy provides coverage or benefits to a resident of this Commonwealth it shall be deemed to be delivered in this Commonwealth regardless of whether the health care insurer issuing or delivering the policy is located within or outside of this Commonwealth.
Cross References This section cited in 31 Pa. Code § 89.801 (relating to authority and purpose; implementation).
§ 89.805. Cost-sharing provisions in policy.
(a) Applicability. Child immunization coverage shall be subject to copayment and coinsurance provisions of a health insurance policy to the extent other medical services covered by the policy are subject to those provisions.
(b) Exemption. Child immunization coverage shall be exempt from deductible or dollar limit provisions in a health insurance policy. This exemption shall be explicitly provided for in the policy.
Cross References This section cited in 31 Pa. Code § 89.801 (relating to authority and purpose; implementation).
§ 89.806. Coverage of child immunizations.
(a) Policy coverage.
(1) A health insurance policy which is not exempt from this subchapter under § 89.809 (relating to exempt policies) shall provide coverage for the cost of the immunization of a child, up to 150% of the AWP of the immunizing agent, if the immunization conforms with ACIP standards in effect on May 21, 1992, governing the issuance of ACIP recommendations for the immunization of children. Those standards are as follows:
(i) The immunization practice is based upon both published and unpublished scientific literature as a means to address the morbidity and mortality of the disease.
(ii) The immunization practice is based upon labeling and packaging inserts for the immunizing agent.
(iii) The immunizing agent is safe and effective.
(iv) The schedule for use of the immunizing agent is administratively feasible.
(2) ACIP recommendations pertaining to the immunization of children are published in the MMWR. The Department of Health will deem an ACIP recommendation pertaining to the immunization of children to satisfy the standards set forth in this subsection unless ACIP alters its standards for recommending immunizations for children by eliminating a standard in this subsection and the recommendation is issued pursuant to those changed standards. An immunization practice which is recommended by ACIP pursuant to only the altered standards is not subject to the insurance coverage set forth in this subsection. An immunization practice which is recommended by ACIP pursuant to standards in addition to the standards enumerated in this subsection shall be deemed to satisfy the standards in this subsection.
(b) Notices. The Department of Health will place a notice in the Pennsylvania Bulletin listing MMWR publications containing ACIP recommendations issued pursuant to the standards in subsection (a). The Department of Health will publish the initial notice contemporaneously with the publication of this subchapter. The Department of Health will update that list in a notice which it will publish in the Pennsylvania Bulletin within 30 days after ACIP publishes a recommendation in the MMWR pursuant to the standards in subsection (a). The Department of Health will recommend that the list set forth in the initial notice and the update to the list set forth in a later notice be codified in the Pennsylvania Code. See Appendix G.
(c) Effective date of coverage. The insurance coverage set forth in subsection (a) shall be effective November 22, 1992, for a child immunization practice recommended by ACIP which was published in the MMWR on or before that date. Thereafter, the insurance coverage described in subsection (a) shall include a child immunization practice recommended by ACIP effective on the date the ACIP recommendation which is issued under the standards in subsection (a) is published in the MMWR.
Cross References This section cited in 31 Pa. Code § 89.801 (relating to authority and purpose; implementation); 31 Pa. Code § 89.802 (relating to definitions); 31 Pa. Code § 89.807 (relating to immunizing agents, doses and AWPs); 31 Pa. Code Chapter 89, Appendix G (relating to ACIP recommendations prescribing child immunization practices); and 31 Pa. Code Chapter 89, Appendix H (relating to immunizating agents and doses).
§ 89.807. Immunizing agents, doses and AWPs.
(a) One hundred fifty percent of the AWP of the immunizing agent that may be used in a child immunization in accordance with § 89.806 (relating to coverage of child immunizations) is to be calculated by taking 150% of the AWP of the purchase unit for the immunizing agent, using the AWP and purchase unit information contained in the Blue Book American Druggist First Databank Annual Directory of Pharmaceuticals as revised in monthly updates prepared by the First Databank Directory of Pharmaceuticals, and then dividing by the number of doses comprising the purchase unit based upon the dose of the immunizing agent used in the child’s immunization. Example: If the AWP of the purchase unit (15 dose 7.5 ml vial) of DTP, Lederle, TRI-IMMUNOL is $172.95, 150% of the AWP of an 0.5 ml dose of DTP, Lederle, TRI-IMMUNOL = 1.5 (150%) x $172.95 (AWP of the purchase unit) ÷ 15 (number of 0.5 ml doses in 7.5 ml vial) = $17.30.
(b) The Department of Health will place a notice in the Pennsylvania Bulletin which contains information on immunizing agents and doses which the Department of Health has extracted from ACIP recommendations issued under the standards in § 89.806(a). The Department of Health will publish the initial notice contemporaneously with the publication of this subchapter. The Department of Health will update the information in a notice which it will publish in the Pennsylvania Bulletin within 30 days after ACIP issues a recommendation pursuant to the standards in § 89.806(a). The Department of Health will recommend that the information contained in the initial notice and the update to that information contained in a later notice be codified in the Pennsylvania Code. The Department of Health will also periodically list AWPs for immunizing agents in a notice which it will publish in the Pennsylvania Bulletin. See Appendix H.
Cross References This section cited in 31 Pa. Code § 89.801 (relating to authority and purpose; implementation); and 31 Pa. Code Chapter 89, Appendix H (relating to immunizing agents and doses).
§ 89.808. Filing requirements.
(a) An insurer shall submit to the Department, for its review and approval, a health insurance policy not exempt from this subchapter under § 89.809 (relating to exempt policies), which is to be delivered, issued for delivery, renewed, extended or modified on or after April 5, 1995. The policy shall contain the necessary provisions to bring it into compliance with the act and this subchapter.
(b) For each health insurance policy issued prior to April 5, 1995, which is not exempt from this subchapter under § 89.809 (relating to exempt policies), the insurer shall submit to the Insurance Department, by June 5, 1995, for its review and approval, a rider or endorsement to bring the policy into compliance with the act and this subchapter.
(c) An insurer shall submit to the Department, for its review and approval, in accordance with the applicable statutory authority, a change in premium rates which is made necessary and appropriate by the insurer’s compliance with the act and this subchapter.
Cross References This section cited in 31 Pa. Code § 89.801 (relating to authority and purpose; implementation).
§ 89.809. Exempt policies.
The following types of health insurance policies are not required to provide child immunization coverage:
(1) An indemnity contract in which payment is a specified amount without regard to the actual expense incurred, a contract which provides reimbursement for hospital expenses only, a contract which covers only dental or vision expenses, an accident-only policy, a long-term care insurance policy and a Medicare supplement policy.
(2) A contract which is noncancelable guaranteed renewable which was issued prior to November 22, 1992.
(3) A contract covering a resident of this Commonwealth who is employed outside this Commonwealth by an employer that maintains health insurance for the individual as an employment benefit.
Cross References This section cited in 31 Pa. Code § 89.801 (relating to authority and purpose; implementation); 31 Pa. Code § 89.803 (relating to provision for coverage in policy); 31 Pa. Code § 89.806 (relating to coverage of child immunizations); and 31 Pa. Code § 89.808 (relating to filing requirements).
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