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Taken from http://www.sos.state.tx.us/texreg/archive/December111998/adopted/health-services.html#282

Chapter 100. Immunization Registry

25 TAC 100.1-100.11

The Texas Department of Health (department) adopts new 100.1-100.11 concerning the creation of an immunization registry and for reporting requirements. Sections 100.1-100.9 and 100.11 are adopted with changes to the proposed text as published in the August 7, 1998, issue of the Texas Register (23 TexReg 8018). Section 100.10 is adopted without change and therefore will not be republished.

These rules will implement House Bill 3054 passed by the 75th Legislature, 1997, which enacted Chapter 900, adding Health and Safety Code 161.007-161.009 requiring the department to establish an immunization registry. The rules implement the legislative intent to protect the confidentiality of patients, insure that their participation is only with informed consent and permit their withdrawal from the registry. At the same time the registry is designed to implement the legislative intent of establishing a repository of accurate, complete, and current immunization records to be used in aiding, coordinating, and promoting efficient disease prevention efforts. The legislature specifically envisioned use of the registry to provide notices by mail, telephone, personal contact, or other means to parents.

Specifically, the sections define terms used in this chapter; address the criteria for inclusion of information and its confidentiality; the responsibilities of providers and payors; the effect of withdrawing consent; the information to be reported to the registry; data quality assurance; the responsibilities of managed care, health maintenance organizations, and insurance companies; reports back to providers; exchange of information between the department and providers; and use of registry data for school and day care enrollment.

The department is making the following changes due to staff comments to clarify the intent and improve the accuracy of the section.

Change: For clarity the term "shall" is used throughout the rules where action or activity is mandated or required. In 100.3(a) it is used in new language. It is substituted for "will" in 100.4(a) twice, (b), (c), 100.5(a),(b),(c),(e),(f),(h), 100.7(b), the caption to 100.8, 100.8(a), (b) twice, 100.9(b), 100.11(a),(b),(c). It is substituted for "should" in 100.5(d). It is substituted for "must" in 100.5(d).

Change: Concerning 100.1, 100.2(b), the age was changed from "21" to "18" to properly reflect the legal age of adulthood. In 100.5(a), the term "21st" was changed to "18th".

Change: Concerning 100.1, the phrase "and are used interchangeably within the rules" was changed in the following definitions: "child", "consent", "immunization history", and "parent" due to clarifications in these definitions and for easier reading of the rules.

Change: Concerning 100.1, the term " patient, client, and child" was changed to "child" for easier reading of the rules. This change occurs in 100.2(a) twice, and 100.2(a)(4).

Change: Concerning 100.1, the term "consent or parental consent" was changed to "consent" for easier reading of the rules. The phase "parental consent" was shortened to "consent" to conform with the new definition. This change occurs in 100.1, 100.2(a), 100.2(a)(5) twice, 100.3(e), 100.4(a), 100.5(b), (d), (k) twice, 100.7(b), and 100.8(a).

Change: Concerning 100.1, the definition of the term "consent" was clarified for easier reading of the rules.

Change: Concerning 100.1, the term and definition of "division" was deleted because it was not used.

Change: Concerning 100.1, the term "parent, managing conservator or guardian" was changed to be included in the definition of "Parent" for easier reading of the rules. This change occurs in 100.1(2), 100.1(8), 100.2(a), 100.2(a)(4), (b) and (d), 100.3(c), 100.4(a),(b) twice, (c), (c)(4), (c)(6), 100.5(g), and 100.6(b), managing conservator or guardian were also deleted.

Change: Concerning 100.1, the term "immunization history and record" was split and redefined as "immunization history" and "immunization record" to distinguish between information going into and being released from the registry and for easier reading of the rules. The term "immunization history" was substituted in the following: for record in 100.1(2), 100.1(5); for "information" in 100.2(a), 100.2(a)(4), 100.2(a)(1), 100.2(b), 100.3(d), 100.4(b) four times, 100.5(b) twice,(d), (e), and (k), 100.6(a), 100.7(b), and 100.8(a); in 100.2(a)(1) for "demographic information and immunization record;" in 100.2(a)(3) for "information on my child", in 100.1(7) for "histories;" for "record" or "a record" in 100.1(2), 100.1(5), 100.5(a), 100.5(c) twice, 100.5(d), 100.5(g)(3)(E) and (j), 100.6(b)(1),(2),and (3), 100.7(a) and (b), and 100.8(a); in 100.5(e) for "vaccine administered;" and in 100.8 caption for "data."

Change: The term "immunization record" was used to signify information released from the registry, to conform with its definition and to be consistent throughout. The term was used in new language in 100.1(2), and as a substitute for the term "information" in 100.2(a)(2) and (a)(3).

Change: Concerning 100.1, the word "Registry" was made lower case to be consistent with other definitions and for easier reading of the rules.

Change: Concerning 100.1, the definition of the term "immunization registry" was clarified for easier reading of the rules.

Change: Concerning 100.2(a), the word "section" was changed to "subsection" to be more precise and for easier reading of the rules.

Change: Concerning 100.2(a), for consistency, the term "health plan" or "health plans" were used throughout to conform with its definition, in place of lengthier phrases. In 100.2(a) and 100.5(e) it was used in new language. In the caption to 100.3 it was substituted for "Health Plans and Insurance Companies." In 100.3(b) it was substituted twice for "Insurance companies health maintenance organizations or other organizations." It was substituted in 100.5(k) for "insurance company, health maintenance organization or other organization that pays or reimburses a claim or encounter for administration of an immunization." It was also substituted in 100.5(k) for "third party payor." In the caption to 100.8 it was substituted for "Texas Managed Care organizations, Texas Health Maintenance Organizations and other Texas Insurers." In 100.8(a) it was substituted for "Organizations."

Change: Concerning 100.2(a), the following language: "100.4 of this title (relating to Withdrawal of Consent)" was substituted for: "paragraph (4) of this section" to be a more precise cross-reference and for easier reading of the rule.

Change: Concerning 100.2(a), the following language: "sent to a health plan or the department to be" was added to be more precise and for easier reading of the rule.

Change: Concerning 100.2(a), grammar change "of a" to "from the" was made. This was due to a change in the definition.

Change: Concerning 100.2(a), "sent to the health plan or the department to be" was added for clarification.

Change: Concerning 100.2(a), the word "subsection" was changed to "section" to be more precise and for easier reading of the rules.

Change: Concerning 100.2(a)(2), the words "Department of Health's" were added to be more precise and for easier reading of the rules.

Change: Concerning 100.2(a)(2), the words "immunization records on my child to a parent of the child" replace "information concerning my child's immunizations to myself" to be more precise and for easier reading of the rules.

Change: Concerning 100.2(a)(4), was renumbered as 100.2(a)(3) due to the deletion of proposed 100.2(a)(3).

Change: Concerning 100.2(a)(4), the last five sentences were deleted since the same information is covered in 100.4.

Change: Concerning 100.2(a)(5), this subsection was added using language from the previous 100.2(a)(4) to separate the information being presented. The words "or if the status of consent is unknown" were added to be more precise.

Change: Concerning 100.2(d) and (e), the words "health care" were removed to match the changed definition of "provider."

Change: Concerning 100.3(a), this was added to clarify provider's responsibility to report if they are not reimburse for an immunization. Subsequent subsections were relettered.

Change: Concerning 100.3(b), the words "After December 31, 1998, an insurance company, a health maintenance organization, or another organization" were removed and replaced with "a health plan" for simplification. The words "an immunization history" were replaced by "immunizations from only the current claim submitted" for clarification. The words "if consent has been obtained" was added. The words "pay" and "reimburse" were made plural to match new wording. This occurred in three places in the paragraph. The words "On or before December 31, 1998, an insurance company, a health maintenance organization, or another organization that pay or reimburse a claim for an immunization of a person younger than 18 years of age may provide an immunization history to the department" were removed to be consistent with definition changes. The words "forward consented immunization information to the registry" was added for simplification and the following was deleted: "must document parental consent for inclusion in the registry before the record is submitted to the department. Insurance companies, health maintenance organizations or other organizations that pay or reimburse a claim will develop a system for documentation of consent status and develop systems or forms necessary to gather required information for the immunization registry. The payor is not required to send the department records where parental consent has been denied." This change was made to allow health plans to establish their own means of assuring that consent exists as required by law.

Change: Concerning 100.3(c), the word "each" was replaced by "a" to simplify the process. The words "their child's" was added to the sentence for clarification.

Change: Concerning 100.4(a), the words "described in 100.2(a)(4) of this title (relating to Inclusion of Information and Confidentiality" were removed and were replaced by the word "consent" to be a more precise definition of consent. Moved the word "entire" from before the word "child's" to after the word for clarification. The words "Immunization Division" were removed and replaced it with "immunization registry" due to the removal of the term "Division" in 100.1, definitions.

Change: Concerning 100.4(b), the words "history to the department or health plan for inclusion in the immunization registry" were added for clarification.

Change: Concerning 100.4(b) the term "statewide" was deleted as redundant.

Change: Concerning 100.4(c), the words "mailed to the Texas Department of Health, Immunization Registry, 1100 West 49th Street, Austin, Texas 78756 and" were added to replace the previous deletion of the address in 100.2(a)(4).

Change: Concerning 100.4(c)(5), the words "where the parent can receive a confirmation notice" were substituted for clarification, and "for confirmation notice" was deleted.

Change: Concerning 100.5(a), the word "All" was removed and replaced with the word "Information on" for clarification. The words "after the effective date of these rules" was removed since the effective date of the statute is the same as the effective date of the rules (January 1, 1999). The words "for which there is consent shall" were added to emphasize that only consented information be sent to the immunization registry. The words "and archived" were added to reflect accurately the disposition of the records.

Change: Concerning 100.5(b), the words "following: last name, first name, date of birth, gender and address of the child who is immunized; name of parent, guardian, or managing conservator and relationship to child; mothers maiden name for record matching; vaccine administered; dose or series number; vaccine lot number; and, manufacturer of the vaccine administered" were removed and replaced with "information listed in subsections (g)(2) and (3) of this section" to be more precise and for easier reading of the rule.

Change: Concerning 100.5(c), this subsection was added using existing language from 100.5(b). Subsequent subsections have been relettered.

Change: Concerning 100.5(d), the word "the record should" was changed to "immunization shall" for clarification. The second sentence was removed and replaced with the language from the Health and Safety Code 161.007(d).

Change: Concerning 100.5(e), the words "Providers and health plans may contact the department (1100 West 49th Street, Austin, Texas 78756, 1-800-252-9152) to establish a provider number and a system of reporting" were added for clarification.

Change: Concerning 100.5(g), the words "health plan" were added for clarification.

Change: Concerning 100.5(g)(1), (2), and (3) the words "must include" was added for clarification.

Change: Concerning 100.5(g)(3), the words "if know" were added for clarification.

Change: Concerning 100.5(g)(3)(E), the words "has been" was replaced by "is" to change verb tense. The words as "defined as" were changed to is to change verb tense.

Change: Concerning 100.5(h), the words "be reported" were added for clarification.

Change: Concerning 100.5(j), the words "from the parent" were added for clarification. The word "historical" was replaced by "all" for clarification.

Change: Concerning 100.5(k), the words "to the department" were added for clarification.

Change: Concerning 100.5(k) the term "state-wide" was deleted as redundant.

Change: Concerning 100.6(a), the word "was" was replaced by "were" to make it more grammatical.

Change: Concerning 100.6(a)(4), a period was added to the end of the sentence.

Change: Concerning 100.6(b), a colon was replaced by a period.

Change: Concerning 100.6(a), a phone number was provided for the convenience of the public.

Change: Concerning 100.6(b)(3), the words "as specified in 100.4 of this title (relating to Withdrawal of Consent)" was added for clarification.

Change: Concerning 100.7(a), the words "of children whose names appear in the registry" were added for clarification.

Change: Concerning 100.8(a), a period was added to the sentence.

Change: Concerning 100.9(b), the words "The provider, health plan and department" were removed and replaced with "Any user of the immunization registry" for clarification.

Change: Concerning 100.11(c), the abbreviation "ID" was replaced with "identification number" for clarification.

The following comments were received concerning the proposed rules. Following each comment is the departments response and any resulting changes.

Comment: One commenter, regarding the preamble, questions the cost estimate of $1.00 per patient encounter where an immunization is provided and $500 a year of participation for the average insurer. The commenter believes this is an underestimate.

Response: The department agrees in part and disagrees in part. The estimate that the commenter refers to is an estimate based on the amount of time to inform a patient about the registry, receive a signature, and submit consented data. The department recognizes that reporting may cost some organizations more than others depending how, or if, information was collected in the past, and any changes which may be made to existing systems. No change was made as a result of this comment.

Comment: Concerning 100.1, one commenter suggested alphabetizing the definitions.

Response: The department agrees and has alphabetized the definitions.

Comment: Regarding 100.1(3), renumbered as 100.1(9), twenty-six comments stated objections to the department defining all providers as agents for the purposes of the immunization registry.

Response: The department agrees. The suggested language was removed from the rules, which is renumbered as 100.1(9).

Comment: Concerning 100.1(4), renumbered as 100.1(10), one commenter believes that the definition of "user" is lax and appears to intentionally remove government employees from accountability.

Response: The department disagrees. The department allows access to those users defined in the Health and Safety Code, 161.008(c)(2). No change was made as a result of this comment.

Comment: Concerning 100.1(6), renumbered as 100.1(11), one comment was received recommending the definition of "vaccine" needs to be redefined and the commenter suggests listing all vaccines to be tracked.

Response: The department agrees in part. The definition of vaccine has been redefined and changes were made to renumbered 100.1(11). As new vaccines become available and medical standards change accordingly, the registry may be modified. Listing all vaccines in the rules would not allow for the addition of new vaccines without rule making.

Comment: Concerning 100.1(8), now renumbered as 100.1(4), one commenter suggests the definition of a health plan needs to be clarified as to whether or not third party administrators and self funded employers are included within the meaning of "health plan."

Response: The department disagrees and responds that the rules are based on the definition for a health plan from the language used in the Health and Safety Code, 161.007(c), which states that any organization that pays or reimburses a claim for an immunization shall provide information. No change was made as a result of this comment. This term was renumbered 100.1(4)

Comment: Concerning 100.1(5), (9), (10), and (11), one commenter suggested the department end each definition with "...are used interchangeably within the rules."

Response: The department has deleted this phrase from all definitions.

Comment: Concerning 100.2(a) and 100.5(a), twenty-five comments were received with objections to the length of time the department plans to store data.

Response: The department disagrees and responds that the Health and Safety Code, 161.008 states that the registry must contain information on the immunization history on each person younger than 18 years of age. The law does not specify the department destroy the data following the child's 18th birthday. Most universities require proof of immunizations prior to enrollment. The department has numerous requests each year from college students attempting to track down this information. After age 18, the department will remove the record from the immunization registry and archive the data. No change was made as a result of this comment.

Comment: Concerning 100.2(a)(1), one commenter asks under what statutory authority is the department collecting demographic information.

Response: The department disagrees and responds that the statutory authority used for collecting demographic information is found in Health and Safety Code, 161.007(d) which states the report shall be in a format prescribed by the department. It is also implied in the Health and Safety Code, 161.007(e) which states the department may use the registry to provide notices by mail, telephone, personal contact, or other means. This task could not be accomplished without demographic information. Demographic information is also necessary for matching and the avoidance of mistaken identity. No change was made as a result of this comment.

Comment: Concerning 100.2(a), one commenter states that this section does not authorize or allow a parent who did not sign a consent form, access to copies of immunization records. Also, children 18 or older should be authorized to receive copies of their own records.

Response: The department agrees. In 100.2(a)(1), the word "myself" was changed to "the parent" in 100.2(a)(2). Although the statute does not expressly allow for release of information to children in the registry when the child becomes 18 years old or older; under the Open Records Act, Government Code, 552.023 such a person would have a special right of access to their own immunization record.

Comment: Concerning 100.2(a)(2)(C), one commenter suggested the word "to" should be changed to "of."

Response: The department disagrees. The word "to" was used in the Health and Safety Code, 161.008(c)(2). No change was made as a result of this comment.

Comment: Concerning 100.2(a)(2)(D), (E), and (G), twenty-eight comments were received stating objections to release of information to the Commissioner of Health or designee, past or present health plan, and the Texas Department of Health and Human Services.

Response: The department agrees with the comments. The language was deleted from 100.2(a)(2).

Comment: Concerning 100.2(a)(3), twenty-six commenters object to the re-release of data to providers who both administer and promote vaccine.

Response: The department agrees. Proposed 100.2(a)(3) was deleted.

Comment: Concerning 100.2(a)(3), twenty-six comments were received with concerns about the re-release of data to other state registries and concerns that this will allow release of information to a national registry in the event one is created.

Response: The department agrees and responds that the legislation did not address re-release to other state registries, therefore the language in proposed 100.2(a)(3) has been deleted.

Comment: Concerning 100.2(a)(4), renumbered now as 100.2(a)(3), one commenter feels that when a request for withdrawal of a record is received by the department from the parent, it should also be forwarded to the health plan.

Response: The department disagrees. The registry does not track the health plan with whom the child is affiliated. It is the responsibility of the parent to notify the provider that consent has been withdrawn and no further records should be forwarded to the department. No change was made as a result of this comment.

Comment: Concerning 100.2(a)(5) renumbered as 100.2(a)(4), one commenter believes the department can not be trusted to carry out the task of completely deleting a child's entire record upon the request of the parent.

Response: The department disagrees and responds that any parent who suspects that their child's records have not been deleted can verify deletion by asking the department, or any authorized user, to check their child's information in the registry. No change was made as a result of this comment.

Comment: Concerning 100.2(a)(5) renumbered as 100.2(a)(4), one commenter suggested the following words should be added to the end of the paragraph "or if the status of parental consent is unknown."

Response: The department agrees and has added the suggested language to renumbered 100.2(a)(4).

Comment: Concerning 100.2(a)(5) renumbered as 100.2(a)(4), one commenter states there is reference to a signature block, but it is unclear to what document this is referring.

Response: The department disagrees and responds that the context makes clear that the signature block relates to the parental consent statement. Providers may develop their own forms, using the parental consent language defined in the rules, however, the form must include a signature block or place for the parent signature. No change was made as a result of this comment.

Comment: Concerning 100.2(a)(5) renumbered as 100.2(a)(4), one commenter asked how consent will be communicated between the provider and the health plan. The commenter also states that this creates a potential for either duplication or inadvertent lack of reporting.

Response: The department responds that 100.3(d) renumbered as 100.3(e), states that the written consent for inclusion shall be maintained with the provider. If the provider has consent and does not submit the immunization to a health plan, they should indicate that consent has been received when the record is forwarded to the department, see Health and Safety Code, 161.003(c). If the provider submits the immunization history to a health plan it is the responsibility of the health plan and the provider to decide how to communicate the consent status. Section 100.3(a) renumbered as 100.2(b), states that only the consented immunization histories should be forwarded to the department. No change was made as a result of this comment.

Comment: Concerning 100.2(b), twenty-eight comments were received with objections to consent obtained on a child's birth certificate and previous consent procedures utilizing the Vaccine Information Statements (VIS).

Response: The department disagrees with the first comment and agrees with the second comment. Immunizations begin at birth. For those parents that desire for their children to be included in the registry, it is important that we capture as many immunizations as possible. Parents make many important decisions at the time of birth. The department will provide informational materials to obstetricians for dissemination prior to the birth of the child. The consent forms the commenters refer to are the forms used prior to the legislation requiring parental consent. The new forms have the parental consent language for the registry separate from the consent for the immunization. The department has begun distribution of the new forms, with instructions to destroy and recycle outdated forms. The parental consent language is based on the most current consent language at the time of printing. No change was made as a result of this comment.

Comment: Concerning 100.2(b), twenty-six comments were received stating objections to the consent being required "one time only."

Response: The department disagrees. Health and Safety Code, 161.007(a), states that the department by rule shall develop guidelines for requiring the written consent of the parent, managing conservator, or guardian. It does not specify that parents must re-sign consent forms at each immunization visit. Parents have the option to rescind their consent at any time. No change was made as a result of this comment.

Comment: Concerning 100.2(b), one commenter states that gaining consent on the birth certificate is an excellent approach, but it will only benefit the health plan if they have access to the information.

Response: The department disagrees that health plans should have access to the information. The Health and Safety Code 161.008(c)(2) does not allow the department to release consent status to the health plans. No change was made as a result of this comment.

Comment: Concerning 100.2(d), one commenter states that parents who have lawful medical or religious exemptions could be subject to routine warning letters about their child being "past due" for immunizations.

Response: The department disagrees. Private providers who do their own recall will now have the ability to know who has medical or religious exemptions. A contact "yes" or "no" flag is available in the state immunization registry. The flag can be set to "no contact" if the child's parents do not wish to be contacted for recall and reminder and the department is notified of that fact. No change was made as a result of this comment.

Comment: Concerning 100.2(e), two commenters requested that "good faith" be defined.

Response: The department disagrees with the commenter. The law defines "good faith" as an intangible and abstract quality with no technical meaning or statutory definition, and it encompasses, among other things an honest belief, the absence of malice and the absence of design to defraud. The definition of "good faith" was not added to 100.1. No change was made as a result of this comment.

Comment: Concerning 100.2(a)(2)(G), one commenter objects to release of immunization data to a health care plan in which a child is or was enrolled.

Response: The department agrees with the comment. The language was deleted from the rules.

Comment: Concerning 100.3(a) renumbered as 100.3(b), one comment was received about the communication process for record transfer between provider and the health plan. The health plans believe the law and the rules create a "broken information loop."

Response: The department disagrees and responds that the information flow the commenter refers to is mandated by the law, Health and Safety Code, 161.007(d). No change was made as a result of this comment.

Comment: Concerning 100.3(a) renumbered as 100.3(b), one commenter suggests "health plan" be used in place of "insurance company."

Response: The department agrees. "Health plan" has been substituted each place an "insurance company, a health maintenance organization or other organization that pays or reimburses a claim" in 100.3(b), 100.5(d) and (k), and section title of 100.8.

Comment: Concerning 100.3(c) renumbered as 100.3(d), one commenter feels this section, requiring external systems supplying the immunization registry with data to contain a consent flag, is not needed in the rules.

Response: The department disagrees. This rule states that external computer systems supplying immunizations to the department must include a parental consent flag indicating parental consent. Since only records flagged "yes" will be forwarded to the registry, this indicator flag will allow external systems to query their databases and only send the registry records where the indicator flag has been set to "yes." No change was made as a result of this comment.

Comment: Concerning 100.3(a) renumbered as 100.3(b), a commenter believes the paragraph should be modified to read "vaccines must be administered by a licenced health care facility and an individual licensed health care professional."

Response: The department disagrees. The definition of a provider is found in renumbered 100.1(9) and is not necessary in this section of the rules. No change was made as a result of this comment.

Comment: Concerning 100.3(c) renumbered as 100.3(d), one commenter states that maintaining a system to document consent by the health plan could be cost prohibitive.

Response: The department disagrees and responds that a method or system for the documentation consent status is necessary, but the precise method is up to the health plan. The health plans must be able to separate the consented data from the non-consented data. Only the consented data can be forwarded to the registry. No change was made as a result of this comment.

Comment: Concerning 100.3(c) renumbered as 100.3(d), one comment was received about immunization registry linking with other unspecified databases and the need for "external computer systems" to incorporate a computer field that indicates whether or not consent has been obtained. The commenter feels the department should list external computer systems that can be linked to the tracking system.

Response: The department disagrees. Insurance companies, private providers, managed care organization, health maintenance organizations, public health and other billing vendors will be supplying the department with immunization histories. An indicator field will be used by the external systems to only supply the immunization registry with consented records. It is not feasible to list all the external computer systems that will be supplying the immunization registry with data. No change was made as a result of this comment.

Comment: Concerning 100.4(a), one commenter is concerned that only immunization information will be deleted, leaving the department to maintain all other personal information in the files.

Response: The department agrees in part and responds 100.4(a) states the child's entire history, which includes the immunization and identifying demographic information, will be removed from the immunization registry. The wording of this subsection has been changed to clarify this point.

Comment: Concerning 100.4(a), one commenter believes a copy of the confirmation of a withdrawal letter, which is sent to the parent, should also be sent to the health plan.

Response: The department disagrees. The law does not allow the department to release information to the health plans. No change was made as a result of this comment.

Comment: Concerning 100.4(c)(5), one commenter asks if the department intends to issue vaccine notices and how that will affect fiscal implications.

Response: The department may assist providers with recall notices. Recall and reminder reports will, for the most part, be generated by the providers. The provider may or may not choose to use recall and reminder features. The department believes that dollars spent on immunizations and recall are appropriately utilized, and that this use of the registry is authorized by Health and Safety Code, 161.007(e). No change was made as a result of this comment.

Comment: Concerning 100.5, one commenter states that the rules do not appear to request any information regarding negative reactions to specific vaccines.

Response: The department confirms this interpretation of the rules. The rules do not request any information regarding negative reactions to specific vaccines. The registry is not designed to be a medical record, only a database holding a list of vaccines administered to the child. The provider is appropriately responsible to determine any contraindications to vaccinations. The registry does include an "adverse reaction flag" which defaults to "no," but may be changed to yes, if an adverse reaction is reported. The flag produces a reminder notice to the provider to submit an adverse reaction report to the department. No change was made as a result of this comment.

Comment: Concerning 100.5(a), one commenter feels this rule leaves the door open for the department to change or add other required vaccines.

Response: The department confirms this interpretation of the rules. The rules are left flexible allowing the immunization registry the ability to add or change required vaccines as medical standards change. No change was made as a result of this comment.

Comment: Concerning 100.5(b), and (f) renumbered as 100.5(g), one commenter feels the information requested should be compatible with the required information on the Health Care Financing Administration (HCFA) 1500 form.

Response: The department agrees in part with this comment. The information will be compatible with most of the required information on the HCFA 1500, however, this form does not capture some of the required information for the registry. No change was made as a result of this comment.

Comment: Concerning section 100.5(d) renumbered as 100.5(e), one commenter questions why health plans must submit the immunization data within 25 days after the receipt from the provider and when the data are received directly from the immunization provider they are given 30 days to submit their information.

Response: The department responds immunizations are recommended at two month intervals during the first 6 months of life. The insurance companies must forward the information to the department after it is received from the provider. The department is concerned that the last doses will not be recorded before the next series is due. The provider needs this information to appropriately assess current immunization status. No change was made as a result of this comment.

Comment: Concerning 100.5(f)(2) renumbered as 100.5(g)(2), twenty-seven comments were received stating objections to the amount of data the department is requiring for the registry.

Response: The department disagrees and responds that the Health and Safety Code, 161.008(a) states: an immunization record is part of the immunization registry. "An immunization record contains the: (1) name and date of birth of the person immunized; (2) dates of immunization; (3) types of immunization administered; and (4) name and address of the health care provider administering the immunization." The definition of an immunization record in the Health and Safety Code refers to what a record consists of when released, in hard copy, from the registry. This was never intended to be the only information the registry receives. The information provided in this list is not enough to match records or adequately track a child's immunization history. If the parent consents to participate in the registry, they consent for the tracking of the "required fields". Children could be adversely affected, if decisions were made based on records that are not accurate. No change was made as a result of this comment.

Comment: Concerning 100.5(f)(2)(C) renumbered as 100.5(g)(2)(C), twenty-seven comments were received stating objections to social security number being labeled in the rules as "if available", not "optional."

Response: That department disagrees and responds that a record will be accepted without a social security number for the child if this number is not available to the provider. This information is very important in creating a unique record. The department needs the social security number to assure that immunization records are reliable and matched to the appropriate child. No change was made as a result of this comment.

Comment: Concerning 100.5(f)(3) renumbered as 100.5(g)(3), one commenter asks if the vaccine type, date of vaccine, vaccine lot number, dose or series number and name of manufacturer are included on the immunization records requested by parents.

Response: The department responds that only the vaccine type, date of vaccine and dose and series number are provided on the reports requested by parents. The vaccine lot number and manufacturer are provided only to the provider. No change was made as a result of this comment.

Comment: Concerning 100.5(f)(3)(D) renumbered as 100.5(g)(3)(D), one commenter states that if this section applies to health plans it should be restated to read "dose or series number (if known)."

Response: The department agrees. The language was added to the section.

Comment: Concerning 100.5(f)(3) renumbered as 100.5(g)(3), one commenter questioned the accuracy and availability of data provided by the health plans. The commenter also stated concern about the ability of department to match records. Also, concern that the health plan does not receive much of the "required" information, such as vaccine lot number, dose and series numbers.

Response: In response to this concern, the department utilizes sophisticated software which matches imported records. With all required information listed in 100.5(g)(2) and (3), the registry can accurately match records. The health plan cannot forward consented information to the registry that it does not receive from the provider. No change was made as a result of this comment.

Comment: Concerning 100.5(f) renumbered as 100.5(g), one commenter is concerned that claims billing systems are not set up to automatically capture the level of detailed information required for the registry. Adding fields and modifications to pre-existing programs is expensive and time consuming.

Response: The department responds that the mandate to receive immunization histories from health plan billing systems was determined by the Health and Safety Code, 161.007(c). No change was made as a result of this comment.

Comment: Concerning 100.5(g) renumbered as 100.5(h), one commenter states that the department needs to clarify how to report evidence of immunity to vaccine preventable disease.

Response: The department responds that the registry will be modified to accept evidence of immunity in lieu of immunization. Until the registry is modified, specific guidelines for reporting can not be provided. No change was made as a result of this comment.

Comment: Concerning 100.5(j) renumbered as 100.5(k), one commenter asks if this section pertains to information submitted by providers when the child does not have any type of health coverage.

Response: The department confirms this interpretation of the rules. This section applies to immunizations that are not billed to a health plan. No change was made as a result of this comment.

Comment: Concerning 100.6(a), twenty-seven comments were received with objections to the use of data obtained prior to the effective date of these rules.

Response: The department disagrees. Many parents throughout the state believe, and are expecting, the department to be collecting immunization data for their children. All records, for which consent status could not be determined, obtained through the Bureau of Vital Statistics were deleted in June 1998. No change was made as a result of this comment.

Comment: Concerning 100.6(a), one commenter requests no deleting of any currently loaded public data because the registry is only worthwhile if it is populated.

Response: The department agrees with the commenter on the importance of grandfathering data. No change was made as a result of this comment.

Comment: Regarding 100.7(a), two commenters object to providers being required to permit the inspection of immunization records for quality assurance purposes by the department. One commenter suggests that this may be illegal.

Response: The department disagrees. Chapter 900, 2, Acts of the 75th Legislature, states: "The Texas Department of Health shall evaluate the immunization registry, established under Section 161.007, Health and Safety Code, as added by this Act, two years after its implementation date to determine if the immunization registry is meeting its stated goals and objectives. The Texas Department of Health shall report to the legislature on February 1 of each odd-numbered year concerning the maintenance and operation of the registry." In order to evaluate the quality of the data, the department must be able to inspect immunization records. For clarification the rules were modified in 100.7(a) to read "records of children whose names appear in the registry" will be inspected.

Comment: Concerning section 100.8(a), one commenter is concerned that 25 business days is not adequate time to provide the immunization information from the health plan unless a consent is received with each immunization.

Response: The department disagrees. It is the responsibility of the provider and the health plan to communicate that consent to participate in the registry has been obtained. Health plans do not have to research consent status. Health plans are only responsible for forwarding records to the department when they are assured that consent has been given. No change was made as a result of this comment.

Comment: Concerning 100.8(a), one commenter proposed changing 25 business days to 60 business days, giving health plans more time to comply.

Response: The department disagrees. Immunizations are recommended at two month intervals during the first 6 months of life. If the health plan waited the full 60 days for reporting, the child would be due for the next series before the first series was received and entered into the registry. The provider needs this to appropriately assess current immunization status. No change was made as a result of this comment.

Comment: Concerning 100.8(a), one commenter asks if the health plan is obligated to confirm consent on each submission to the registry. If so, the statement should be expanded to require a consent modifier on each claim submitted.

Response: The department disagrees and responds that the health plan is under no obligation to confirm consent on each submission. The providers must communicate changes in consent status to the health plans. No change was made as a result of this comment.

Comment: Concerning 100.8(b), twenty-seven comments were received with objections to the use of the Health Level 7 (HL7) data format.

Response: The department disagrees. Health Level 7 (HL7) is a "data standard". It is a common language used for the transfer of data electronically. Completed parts of the HL7 format are being used by other states and countries. The only sharing of data, would be at the request of the parent, to transfer their child's immunization information from our system to another. HL7 will provide a standard format for reporting. No change was made as a result of this comment.

Comment: Concerning 100.9(a), twenty-five comments were received with concerns that no limits are written into the rule for recall and reminder systems.

Response: The department disagrees that limits should be defined by rule. However, currently the immunization registry only has the capacity to recall a child three times. No change was made as a result of this comment.

Comment: Regarding 100.9(b), twenty-seven comments were received stating objections to the department omitting schools and day cares facilities from confidentiality requirements.

Response: The department agrees. The language was rewritten to state that any user of the immunization registry will maintain the confidentiality of all immunization reports. A certain amount of sharing of information may be required by Education Code 38.002(b). No change was made as a result of this comment.

Comment: Concerning section 100.11, one commenter asked if the health plans have access to this information.

Response: The department responds that the Health and Safety Code, 161.008(c)(2), states the information can be released to a public health , a local health department, a physician to the child, or a school or child care facility in which the child is enrolled. This does not include health plans. Release to health plans has been removed from this section of the proposed rules. No change was made as a result of this comment.

Comment: Concerning rules in general, one commenter recommends that our rules include a provision that allows the release of immunization data from the registry for research purposes.

Response: The department responds that the law defines who can have access to the immunization data, and there is no provision for research use. No change was made as a result of this comment.

Comment: Concerning rules in general, twenty-seven comments were received stating objection to the lack of penalties for misuse of the registry.

Response: The department responds that penalties are outlined in the Health and Safety Code 161.009.No change was made as a result of this comment.

Comment: Concerning rules in general, twenty-eight comments were received with objections to the lack of protection against those who choose not to participate.

Response: The department disagrees and responds it is not the practice of immunization providers to pressure parents into entering their children's information into the registry. No change was made as a result of this comment.

The commenters were Belinda Martel, Stacy Shelton, Julie A. Durham, Karen Walters, Debbie Otwell, Mrs. Linda Lowder, Charles Erwin, Trace Carpenter, Mrs. Stacey Burks, Terri Erwin, Kelli Beaty, Angie Wilson, William M. Chop, Jr., M.D., State Senator Jerry Patterson, David L. Tyson, Jon Van Slaars, Angela Nash, Christine Orbin, L.L. Davidson, U.S. Senator Phil Gramm, Randy V. Curtis, M.D., Tina K.King, J. Wilson, Bryan Malatesta, Ms. Joy Rex, Douglas Moore, Nick Curry, M.D., M.P.H.; Texas Medical Association, Tim Nash, Stephanie Marchbanks, Alison Mullins, Francisco Casales, Marcia Cook, Gary Fritzsche; Blue Cross and Blue Shield of Texas, Inc., Roger L. and Sara Moncus, Christine Casales, Candyce B. Hall, Randi Smerud, Larry L. Coffman, Doris M. Brown, Dawn Richardson, Paul Ochoa, Susan Failes, Kathi Seay, Conservative Coalition, Janice Borne, State Representative Jerry Madden, Camellia May, Laurie Smith, T.C. Wascher, M.D., Rebecca Rex, Patricia Zuercher, North Central Texas HEDIS Coalition, Virginia Moore, M.D., Jill Hunt, Jeannine Kline, Mr. & Mrs. R. David Oltrogge, Robert W. Bueker, C.P.A., State Represetative Bob Hunter, Jana Kappel, Denise M. Burgos, M.D. Most commenters were opposed to the proposed rules. Some expressed concerns, asked questions and made suggested recommendations for changes as discussed in the summary of comments.

The effective date of the rules is January 1, 1999.

The new sections are adopted under the Health and Safety Code, 161.007-161.009 requiring the department to establish an immunization registry and by rule develop guidelines; and 12.001, which provides the Texas Board of Health with the authority to adopt rules for the performance of every duty imposed on the board, the department, and the Commissioner of Health.

100.1. Definitions.

The following words and terms, when used in this chapter, shall have the following meanings, unless the context clearly indicates otherwise.

(1)

Child-The person or individual under 18 years of age, to whom a vaccine has been administered.

(2)

Consent-A statement signed by a parent agreeing that the child's immunization history can be included in the registry, and that the child's immunization record may be released from the registry. Consent must be obtained one time only and is valid until the child attains 18 years of age. Parents may choose to withdraw consent at any time.

(3)

Department-The Texas Department of Health.

(4)

Health Plan-An insurance company, a health maintenance organization, or another organization that pays or reimburses a provider for immunizations administered.

(5)

Immunization history-An accounting of all vaccines that a child has received and other identifying information.

(6)

Immunization record- That part of the immunization registry that is released. An immunization record contains the name and date of birth of the person immunized; dates of immunization; types of immunization administered; and name and address of the provider administering the immunization.

(7)

Immunization registry-The database or single repository that contains immunization histories which include necessary personal data for identification. This database is confidential, and access to content is limited to authorized users.

(8)

Parent-The parent, managing conservator, or guardian from whom consent is obtained.

(9)

Provider-Any physician, health care professional, or facility personnel duly licensed or authorized to administer vaccines.

(10)

User-An entity or individual authorized by the department to access immunization registry data.

(11)

Vaccine-Includes toxoids and other immunologic agents which are administered to children to elicit an immune response and thus protect against an infectious disease.

100.2. Inclusion of Information and Confidentiality.

(a)

The immunization registry shall contain information on the immunization history that is obtained by the department under this section of each person who is younger than 18 years of age and for whom written consent has been obtained in accordance with this section. The department shall remove information from the registry for any person for whom consent has been withdrawn under 100.4 of this title (relating to Withdrawal of Consent). The provider shall obtain the written consent from the parent of a child before any immunization history relating to the child is sent to a health plan or the department to be included in the registry. The consent language should be substantially similar to the text of paragraphs (1), (2) and (3) of this subsection. The department shall prepare appropriate forms to obtain consent and make sure they are available to providers.

(1)

"I authorize the placement of my child's immunization history into the Texas Department of Health's Immunization Registry.

(2)

"I authorize the Texas Department of Health's Immunization Registry to release past, present, and future immunization records on my child to a parent of the child and any of the following:

(A)

public health district;

(B)

local health department;

(C)

physician to the child;

(D)

school in which the child is enrolled; and

(E)

child care facility in which the child is enrolled.

(3)

"I understand that I may withdraw the consent to place my child's immunization history in the immunization registry and my consent to release my child's immunization record from the immunization registry at any time by written communication to the Texas Department of Health, Immunization Registry, 1100 West 49th Street, Austin, Texas, 78756."

(4)

A parent of a child who agrees to the submission of their child's immunization history to the immunization registry should sign a signature block indicating their written consent to participate.

(5)

A consent statement must be signed for participation in the immunization registry. No information should be forwarded to the department if consent is denied or if the status of consent is unknown.

(b)

At birth, parents will be able to consent for the child's future immunization history to be included in the immunization registry by indicating approval on the birth certificate. This written consent will be valid until age 18 unless the parent notifies the department that consent is withdrawn.

(c)

As required by Health and Safety Code, 161.007, all information which identifies individuals shall be protected as medical information in accordance with the Medical Practice Act, Texas Civil Statutes, Article 4495b, 5.08.

(d)

As provided in Health and Safety Code, 161.007(e), the department may use the registry to provide notices by mail, telephone, personal contact, or other means to a parent regarding his or her child who is due or overdue for a particular type of immunization according to the department's immunization schedule. The department shall consult with providers to determine the most efficient and cost-effective manner of using the immunization registry to provide these notices.

(e)

A provider or health plan which provides information to the immunization registry in good faith pursuant to this section is not subject to civil liability, as described in Health and Safety Code, 161.007(g).

100.3. Providers and Health Plans.

(a)

After December 31, 1998, a provider that administers a vaccine to a person younger than 18 years of age and does not submit a claim for reimbursement to a health plan shall provide an immunization history to the department if consent has been obtained.

(b)

A health plan that pays or reimburses a claim for an immunization of a person younger than 18 years of age shall provide the immunizations from only the current claim to the department, if consent has been obtained. A health plan that pays or reimburses a claim may forward consented immunization history to the registry.

(c)

A provider shall inform a parent of the child about the immunization registry in writing, and provide them with an opportunity to consent to the inclusion of their child's information in the immunization registry.

(d)

External computer systems supplying the immunization registry with immunization history will incorporate an indicator field that records whether written consent for inclusion has been obtained.

(e)

If consent for participation in the immunization registry is obtained, the written consent for inclusion shall be maintained with the provider.

100.4. Withdrawal of Consent.

(a)

Upon receipt of a request to withdraw consent, the child's entire history shall be removed from the immunization registry. A written confirmation shall be provided to the parent of removal from the immunization registry within 30 business days of receipt by the immunization registry.

(b)

Providers shall forward a child's immunization history to the department or health plan for inclusion in the immunization registry only when the parent has signed a written consent for the immunization history to be included in the immunization registry. The department shall not keep a child's immunization history in the immunization registry or other files when the parent has requested in writing that the immunization history be deleted from the immunization registry.

(c)

The department shall prepare appropriate forms to withdraw consent to participate in the immunization registry, and shall make them available to providers. A completed form is not required to refuse to participate in the immunization registry. A parent who consents and wishes to withdraw the consent at a later date, may send a signed request, in lieu of the form prepared by the department. The written request must be mailed to the Texas Department of Health, Immunization Registry, 1100 West 49th Street, Austin, Texas 78756 and contain the following information:

(1)

child's name;

(2)

child's date of birth;

(3)

child's gender;

(4)

name of parent;

(5)

an address where the parent can receive a confirmation notice;

(6)

signature of parent; and

(7)

date of signature.

100.5. Reportable Information.

(a)

Information on vaccines administered shall be sent in a manner consistent with these rules and procedures issued by the department. All immunizations for which there is consent shall be reported to the immunization registry until the child's 18th birthday. The immunization history will be purged or removed automatically from the immunization registry and archived on the child's 18th birthday.

(b)

After consent is obtained, a provider reporting directly to the immunization registry, shall submit all the immunization history required. Required immunization history consists of the information listed in subsections (g)(2) and (3) of this section.

(c)

A child's immunization history shall be accepted without a social security number. However, social security numbers are very important to assure that the immunization histories are complete and adequately match. If available, the social security numbers shall be forwarded to the department. Other information specified on forms and data file layouts as optional should be provided, with the consent of a parent, when available.

(d)

Providers receiving notifications from parents requesting that their child's immunization history not be reported to the immunization registry shall maintain documentation of the notice at the provider's office and no information shall be forwarded to the department. A health care provider who administers an immunization to a person younger than 18 years of age shall provide an immunization history to the department unless the immunization history is submitted to a health plan that pays or reimburses a claim for an immunization to a person younger than 18 years of age. If consent for participation in the immunization registry is obtained, the immunization history shall be forwarded to the department by the health plan.

(e)

Beginning on January 1, 1999, immunization histories shall be reported to the department by paper forms, electronic transfer, fax, mail, telephone, or direct data entry into the immunization registry within 30 business days of administering a vaccine in a format prescribed or approved by the department. Providers and health plans may contact the department (1100 West 49th Street, Austin, Texas 78756, 1-800-252-9152) to establish a provider number and a system of reporting. Reporting by telephone is limited to providers that administer vaccine to less than 25 children per month.

(f)

Reports submitted by electronic transfer shall meet data quality, format, security, and timeliness standards prescribed by the department.

(g)

Beginning on January 1, 1999, with written consent from a parent, providers and health plans shall report the following necessary information to identify a child, adequately track the child's immunization status, allow for effective recall and reminder systems and satisfy the required data elements in the immunization registry.

(1)

Provider information must include:

(A)

the health care provider's name (first, middle initial, last);

(B)

business address (street, city, zip code); and

(C)

business telephone number (including area code).

(2)

Child and parent information must include:

(A)

child's name (first, middle initial, last);

(B)

child's address;

(C)

child's social security number (if available);

(D)

gender of the child;

(E)

child's date of birth; and

(F)

mother's maiden name (if available).

(3)

Vaccine information must include:

(A)

type of vaccine administered;

(B)

date the vaccine was administered (month, day, year);

(C)

vaccine lot number (if known);

(D)

dose or series number (if known); and

(E)

name of vaccine manufacturer (if known). If the immunization history is entered as historical data, the lot number and manufacturer are not required. Historical data are immunizations that were administered prior to the present date and/or administered by a different provider.

(h)

Evidence of immunity to vaccine preventable disease shall be reported.

(i)

In addition to data required, optional information which aids in the tracking of children in the immunization registry may be supplied at the discretion of the parent.

(j)

If written consent is obtained from a parent, providers should enter all immunization history.

(k)

Beginning January 1, 1999, with written consent, a provider shall submit immunization history to the immunization registry. The provider is not required to submit immunization information to the department when the immunization information is submitted to a health plan. Providers shall submit evidence of consent when they submit the documentation of services provided to the health plan.

100.6. Information Included in the Immunization Registry Prior to September 1, 1997.

(a)

Immunization histories contained in the immunization registry prior to September 1, 1997 that were obtained from the following sources will remain in the immunization registry and may be released from the immunization registry:

(1)

Integrated Client Encounter System (ICES);

(2)

Women, Infants and Children (WIC);

(3)

Medicaid; and

(4)

Texas Health Steps (formerly known as Early and Periodic Screening Diagnosis and Treatment - EPSDT).

(b)

The department will develop informational materials for distribution and posting at all provider's offices who have access to the immunization registry and in the provider offices using the Integrated Client Encounter System (ICES), Women, Infants and Children (WIC), Medicaid, Texas Health Steps (formerly known as Early and Periodic Screening Diagnosis and Treatment - EPSDT) that will notify parents about the following.

(1)

Their child may already have an immunization history in the immunization registry from the one or more of the sources listed in subsection (a) of this section.

(2)

The parent may request that the department search the immunization registry for the possibility of an existing immunization history. They may call the department's toll free number, (800) 252-9152, or make the request in writing.

(3)

The parent may request that any existing immunization history be withdrawn and deleted from the immunization registry as specified in 100.4 of this title (relating to Withdrawal of Consent).

100.7. Data Quality Assurance.

(a)

As needed and for the purpose of assuring the quality and accuracy of the consented data submitted to the immunization registry, each provider will allow the department to inspect the immunization history of children whose names appear in the registry stored with the provider.

(b)

For immunization history with written consent, a provider shall, upon request of the department, supply missing immunization history, if known, or clarify immunization history submitted to the department.

100.8. Health Plans Shall Provide Immunization History to the Department.

(a)

Health plans to which providers submit a claim or encounter information for an immunization, shall in turn submit the required immunization history to the department within 25 business days from receipt from the provider. The organization must be able to verify the presence of the consent for participation in the immunization registry before the history is forwarded to the department.

(b)

Automated data exchange shall conform to standards prescribed by the department. Data exchange shall follow the national standard for data exchange, known as Health Level 7 (HL7), when this format is completed.

100.9. Reports.

(a)

Authorized and registered providers or health plans may request recall and reminder reports from the immunization registry to provide notices of an upcoming or overdue immunization.

(b)

Any user of the immunization registry shall maintain the confidentiality of all immunization reports.

100.11. Confidentiality.

(a)

Information contained in the immunization registry is confidential. Registered providers using the immunization registry shall be required to sign a confidentiality disclaimer statement.

(b)

The department shall register providers and assign security levels.

(c)

Registered providers shall be assigned a user identification number and password. The registered provider will be encouraged to periodically change the assigned password. The password will be displayed on the screen as asterisks.

Filed with the Office of the Secretary of State on November 24, 1998.

TRD-9817962

Susan K. Steeg

General Counsel

Texas Department of Health

Effective date: January 1, 1999

Proposal publication date: August 7, 1998

For further information, please call: (512) 458-7236

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