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Proposed Rules Taken from the August 7, 1998 issue of the Texas Register

See http://www.sos.state.tx.us/texreg/index.html.


TITLE health-services

Part I. Texas Department of Health

Chapter 100. Immunization Registry

25 TAC 100.1-100.11

The Texas Department of Health (department) proposes new 100.1-100.11 concerning the creation of an immunization registry and for reporting requirements. 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.

These rules will implement HB 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 and provide for the confidentiality of information it contains.

Previously, the Texas Board of Health (board) adopted proposed rules on February 8, 1998, and were published in the February 20, 1998 issue of the Texas Register (23 Tex Reg 1472). The rules were withdrawn on May 15, 1998 (23 Tex Reg 5650) to allow the department to further consider and respond to public comment.

Robert D. Crider, Jr., M.S., M.P.A., Director, Immunization Division, has determined that for the first five year period the sections are in effect, there will be no fiscal implications to state or local government as a result of enforcing or administering the sections as proposed. Mr. Crider bases his estimate on the fiscal note prepared for the legislature on House Bill No. 3054, which became Chapter 900.

Mr. Crider has determined that for each year of the first five years the sections are in effect, the public benefit anticipated as a result of these sections, is a centralized immunization registry that is the most efficient method for providers, both public and private, to maintain and access a child's immunization history. The public benefits anticipated as a result of reporting to the immunization registry include: better health care for children with less illness and death due to vaccine-preventable diseases, reduced costs due to the elimination of "over-vaccination" or "re-vaccination" because of lost records, reduced occurrences of "missed opportunities" to vaccinate which unnecessarily increase the risk of a child for vaccine-preventable diseases, and greater opportunity for outreach activities in areas of Texas with low immunization levels. Because the immunization records are stored electronically and available from one source, physicians are able to reduce staff time researching immunization histories. The child's complete immunization record will also be more easily available to school nurses, child care centers, and universities which require immunization information for enrollment. Software, installation, training and support for the tracking system, including the phone line access to the database, are provided by the department. The major costs to small business associated with the program will be to those medical practices providing immunizations. There will be increased time spent providing information to patients on the program, and providing them with consent forms and forms to decline participation. The consent form is kept with the medical record, so staff time must be spent filing them. These costs will vary from one practice to another depending upon how many patients are treated, how many participate in the program, how much time is devoted to explaining the program to each patient, filing the consents and the value of the staff time devoted to these tasks, and how providers are reimbursed for providing immunizations. Mr. Crider estimates the average cost to be $1.00 per each patient encounter where an immunization is provided. The cost to small business will be reduced by automated and streamlined billing of immunizations. Aside from the costs to small businesses, there will be certain costs imposed on other persons. Those who wish to withdraw parental consent must communicate this to the department, involving minimal postage, currently $.32, soon to increase to $.35. The department will develop and distribute postage paid forms for withdrawal of parental consent for registry tracking. Large insurers are required to submit data after 1998, and will incur certain staffing and transmittal costs, though larger entities will almost certainly file requested information electronically. The department estimates that the average insurer will incur costs equivalent to $500 per year of participation. There is no anticipated impact on local employment.

Comments on the proposal may be submitted to Robert D. Crider, Jr., M.S., M.P.A., Director, Immunization Division, 1100 West 49th Street, Austin, Texas, 78756, (512) 458-7284. Comments will be accepted for 30 days following the date of publication of this proposal in the Texas Register .

The new sections are proposed under the Health and Safety Code 161.007 which requires the board to adopt rules to implement the immunization registry, and 12.001 which provides the board with authority to adopt rules for the performance of every duty imposed by law on the board, the department, and the commissioner of health.

These new sections affect the Health and Safety Code, Chapter 161.

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)

Department-The Texas Department of Health.

(2)

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

(3)

Provider-Any physician, health care professional, or facility personnel duly licensed or authorized to administer vaccines. All providers are eligible to participate in the registry. All providers become agents of the Texas Department of Health for the purposes of the immunization registry.

(4)

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

(5)

Patient, client and child-The person or individual to whom a vaccine has been administered and are used interchangeably within the rules.

(6)

Vaccine-Includes toxoids and other immunologic agents.

(7)

Division-The Immunization Division of the Texas Department of Health, central office in Austin, Texas.

(8)

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

(9)

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

(10)

Consent or parental consent-A parent, managing conservator, or guardian has signed a statement agreeing that the child's record can be included in and released from the registry and are used interchangeably. Consent must be obtained one time only and is valid until the child attains 21 years of age. Parents may choose to withdraw consent at any time.

(11)

Parent, managing conservator, or guardian-The person or individual from whom consent is obtained and are used interchangeably within the rules.

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 parental consent has been obtained in accordance with this subsection. The department shall remove information from the registry for any person for whom consent has been withdrawn under paragraph (4) of this section. The provider shall obtain the written consent of a parent, managing conservator, or guardian of a patient before any information relating to the patient is included in the registry. The consent language should be substantially similar to the text of paragraphs (1), (2), and (3) of this section. 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 demographic information and immunization record into the Texas Department of Health's Immunization Registry.

(2)

"I authorize the Texas Immunization Registry to release past, present, and future information concerning my child's immunizations to myself and any of the following:

(A)

public health district;

(B)

local health department;

(C)

physician or immunization provider to the child;

(D)

Texas Department of Human Services for service eligibility verification;

(E)

the Commissioner of Health or designee;

(F)

school or child care facility in which the child is enrolled; and

(G)

health care plan in which the child is or was enrolled.

(3)

"I authorize the entities listed in paragraph 2(A), (B), (C), (D), and (E) of this subsection to further re-release this information to promote the availability of accurate, complete and current, immunization records to those entities and individuals who both administer and promote immunizations and the immunization registries of other states.

(4)

"I understand that I may withdraw the consent to place information on my child in the immunization registry and my consent to release information 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."

(5)

A parent, managing conservator, or guardian of a patient, who agrees to the submission of their child's immunization information to the immunization registry should sign a signature block indicating their written consent to participate. Parents who have already consented to adding their child's immunization information to the registry and who wish to withdraw consent should sign a statement stating: "I do not want my child (name of child), dates of immunization(s) and related information to be included in the statewide immunization registry." or a similar statement. Parents choosing this option, must date and sign the statement and mail it to the Texas Department of Health, Immunization Registry, 1100 West 49th Street, Austin, Texas, 78756. Upon receipt of the request, the department will delete the complete record from the immunization registry and the department will mail a confirmation letter to the parent, managing conservator or guardian of the child that the complete record was deleted from the immunization registry. All information will be completely deleted from the immunization registry. It is the responsibility of the immunization provider or third party payor to insure that records are not forwarded to the immunization registry unless a parent has consented. A parental consent statement must be signed for participation in the immunization registry. No information should be forwarded to the department if parental consent is denied.

(b)

At birth, parents will be able to consent for the child's future immunization information to be included in the immunization registry by indicating approval on the birth certificate. This written consent will be valid until age 21 unless the parent, managing conservator or guardian 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(g), the department may use the registry to provide notices by mail, telephone, personal contact, or other means to a parent, managing conservator, or guardian regarding his or her child or ward who is due or overdue for a particular type of immunization according to the department's immunization schedule. The department shall consult with health care providers to determine the most efficient and cost-effective manner of using the immunization registry to provide these notices.

(e)

A health care 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, Health Plans, and Insurance Companies.

(a)

After 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 shall provide an immunization history to the department. 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. Insurance companies, health maintenance organizations or other organizations that pay or reimburse a claim 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.

(b)

A provider shall inform each parent, managing conservator, or guardian of the child about the immunization registry in writing, and provide them with an opportunity to consent to the inclusion of information in the immunization registry.

(c)

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

(d)

If parental 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 described in 100.2(a)(4) of this title (relating to Inclusion of Information and Confidentiality), the entire child's record will be removed from the immunization registry. A written confirmation will be provided to the parent, managing conservator, or guardian of withdrawal from the immunization registry within 30 business days of receipt by the Immunization Division.

(b)

Providers shall forward a child's immunization information only when the parent, managing conservator, or guardian has signed a written consent for the immunization information to be included in the statewide immunization registry. The department will not keep a child's immunization information in the immunization registry or other files when the parent, guardian, or managing conservator, has requested in writing that the immunization information be deleted from the immunization registry.

(c)

The department shall prepare appropriate forms to withdraw consent to participate in the immunization registry, and will make them available to providers. A completed form is not required to refuse to participate in the immunization registry. A parent, managing conservator, or guardian 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 contain the following information:

(1)

child's name;

(2)

child's date of birth;

(3)

child's gender;

(4)

name of parent, managing conservator or guardian;

(5)

parent and child's address for confirmation notice;

(6)

signature of parent, managing conservator or guardian; and

(7)

date of signature.

100.5. Reportable Information.

(a)

All vaccines administered after the effective date of these rules will be sent in a manner consistent with these rules and procedures issued by the department. All immunizations will be reported to the immunization registry until the child's 18th birthday. The immunization record will be purged or removed automatically from the immunization registry on the child's 21st birthday.

(b)

After parental consent is obtained, a provider reporting directly to the immunization registry, will submit all the information required. Required information consists of the 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. A child's immunization record will be accepted without a social security number. However, social security numbers are very important to assure that records 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.

(c)

Providers receiving written notifications from parents requesting that their child's immunization information not be reported to the immunization registry shall maintain the notice at the provider's office and no information shall be forwarded to the department. The immunization provider shall report documentation of the service provided to the insurance company, health maintenance organization or other organization for claims payment or reimbursement. If parental consent for participation in the immunization registry is obtained, the record should be forwarded to the department.

(d)

Beginning on January 1, 1999, vaccines administered will 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. Reporting by telephone is limited to providers that administer vaccine to less than 25 children per month.

(e)

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

(f)

Beginning on January 1, 1999, with written consent from a parent, managing conservator, or guardian, providers must 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:

(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:

(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:

(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 ; and

(E)

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

(g)

Evidence of immunity to vaccine preventable disease.

(h)

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.

(i)

If written consent is obtained, providers should enter historical immunization records.

(j)

Beginning January 1, 1999, with written parental consent, a provider shall submit immunization information to the state-wide immunization registry. The provider is not required to submit immunization information when the immunization information is submitted by an insurance company, health maintenance organization or other organization that pays or reimburses a claim or encounter for administration of an immunization. Providers shall submit evidence of parental consent when they submit the documentation of services provided to the third party payor.

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

(a)

Immunization information contained in the immunization registry prior to September 1, 1997 that was 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, managing conservators or guardians about the following.

(1)

Their child may already have a record 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 record. They may call the department's toll free number or make the request in writing.

(3)

The parent may request that any existing record be withdrawn and deleted from the immunization registry.

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 records stored with the provider.

(b)

For immunization records with written parental consent, a provider will, upon request of the department, supply missing immunization information, if known, or clarify immunization information submitted to the department.

100.8. Texas Managed Care Organizations, Texas Health Maintenance Organizations and other Texas Insurers Will Provide Immunization Data to the Department.

(a)

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

(b)

Automated data exchange will conform to standards prescribed by the department. Data exchange will 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)

The provider, health plan and department will maintain the confidentiality of all immunization reports.

100.10. Acceptability As An Immunization Record.

A printed immunization record obtained from the immunization registry shall be accepted as an official immunization record of the child for the purposes of satisfying the immunization requirements of schools, colleges/universities, and child-care facilities.

100.11. Confidentiality.

(a)

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

(b)

The department will register providers and assign security levels.

(c)

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

This agency hereby certifies that the proposal has been reviewed by legal counsel and found to be within the agency's legal authority to adopt.

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

TRD-9811749
Susan K. Steeg
General Counsel
Texas Department of Health
Earliest possible date of adoption: September 6, 1998
For further information, please call: (512) 458-7236

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