TITLE health-services

Part I. Texas Department of Health

Chapter 37. Maternal and Child Health Services

Subchapter H. Midwives

25 TAC §§37.175, 37.178, 37.180

The Texas Department of Health (department) adopts the repeal of §§37.175, 37.178, and 37.180, concerning documentation and regulation of midwives without changes to the proposed text as published in the January 1, 1999, issue of the Texas Register (24 TexReg 48), and therefore the repeal will not be republished.

The department adopts the repeal of the sections in 25 Texas Administrative Code (TAC) in order that new sections may be adopted by the Texas Midwifery Board at 22 TAC, Examining Boards, Chapter 831, Midwives. The Texas Midwifery Board is authorized by the Texas Midwifery Act (the Act), Texas Civil Statutes, Article 4512i, §8A(b), to adopt rules concerning documentation of midwives; standards for approval of midwifery education courses, instructors, and facilities; standards for midwifery practice; basic and continuing midwifery education requirements; reporting and processing of complaints concerning midwives; disciplinary procedures; procedures for granting initial documentation by reciprocity; and any additional rules necessary to implement any duty imposed on the board by the Act, subject to the approval of the Texas Board of Health. Effective December 1, 1998, the Midwifery Program and the Midwifery Board were administratively transferred from the department's Women's Health Division to the department's Professional Licensing and Certification Division. The new rules adopted by the Midwifery Board at 22 TAC, Chapter 831, can be found in this issue of the Texas Register in the Adopted Rule section.

No comments were received on the proposal during the comment period.

The repeals are adopted under Health and Safety Code, §12.001(b), which provides the board with authority to adopt rules for the performance of every duty imposed by law upon the board, the department and the commissioner of health.

This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority.

Filed with the Office of the Secretary of State on April 26, 1999.

General Counsel

Texas Department of Health

Effective date: May 16, 1999

Proposal publication date: January 1, 1999

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

Subchapter R. School Health Advisory Committee

25 TAC §37.350

The Texas Department of Health (department) adopts new §37.350, concerning the School Health Advisory Committee (committee), with changes to the proposed text as published in the January 29, 1999, issue of the Texas Register (24 TexReg 491). The committee provides assistance to the Texas Board of Health (board) and the department to establish a leadership role for the department in the support for and delivery of school health services.

In 1993, the Texas Legislature passed Senate Bill 383 (now codified in the Government Code, Chapter 2110) which requires that each state agency adopt rules to establish advisory committees. The rules must state the purpose of each committee, state the composition of the committee, describe the tasks of the committee, describe the manner in which the committee will report to the agency, and establish a date on which the committee will be automatically abolished unless the governing body of the agency affirmatively votes to continue the committee in existence.

The new section establishes the committee and provides procedures for its operation. Specifically, the section includes language to describe the purpose and tasks of the committee; to establish a review date of June 1, 2003, for the committee; to define the composition; and to establish requirements and procedures relating to terms of members, officers, meetings, attendance, staff support, parliamentary procedures, subcommittees, statements by members, reports to the board and reimbursement for expenses.

The department is making the following minor change.

Change: Concerning §37.350(i), the language is revised to require the committee to meet at least twice each year. This change is made because of the committee's and the board's need to consider relevant and emerging issues relating to school health on a timely basis.

Twenty two comments were received during the comment period. All of these comments concerned subsection (f)(2). (One of these commenters spoke on behalf of 156 members of the Texas Association of School Nurses.) The following comments were received concerning the proposed section.

Comment: All commenters objected to §37.350(f)(2), which allows inclusion of physician assistants instead of registered nurses on the committee to represent school staff providing direct health care services to children. All commenters concurred that registered school nurses make up the majority of health professionals providing health care services in schools. Commenters also felt that registered school nurses have significantly more experience in providing health services in the school setting than physician assistants. Many commenters stated that although physician assistants are a valuable asset to the health care system in general, they generally lack training in many nursing procedures that are typically performed by registered nurses in the school setting. A number of commenters stated that they are unaware of any physician assistant currently employed in a school setting. The commenters asked that subsection (f)(2) be amended to include only registered nurses and to exclude physician assistants.

Response: The department disagrees that the possible inclusion of a physician assistant on the committee in lieu of a registered nurse will jeopardize adequate representation of registered school nurses on the committee. The department feels that physician assistants can and do offer valuable skills and services in school clinic settings. The board, in appointing members of the committee, may select registered nurses or physicians assistants or a combination of both. That decision will be made at the time of appointments. The rule gives flexibility to the board to make appointments of persons which it feels are appropriate. In addition, appointments under paragraph (5)may include registered nurses. No change was made due to these comments.

The following organizations commented on the new section: Alief Independent School District (ISD), Arlington ISD, Berry Elementary School, Burkburnette ISD, Garland ISD, Glenrose ISD, Grapevine/Colleyville ISD, Gregory Portland ISD, H.E.B. ISD, North East ISD, Skidmore-Tynan ISD, and Texas Association of School Nurses (Regions 2 & 11).

The new section is adopted under the Health and Safety Code, §11.016, which allows the board to establish advisory committees; the Government Code, Chapter 2110, which sets standards for the evaluation of advisory committees by the agencies for which they function; and the Health and Safety Code, §12.001, which provides the board with authority to adopt rules for the performance of every duty imposed by law upon the board, the department, and the commissioner of health.

§37.350. School Health Advisory Committee.

The committee. The School Health Advisory Committee (committee) shall be appointed under and governed by this section. The committee is established under the Health and Safety Code, §11.016, which allows the Board of Health (board) to establish advisory committees.

Applicable law. The committee is subject to the Government Code, Chapter 2110, concerning state agency advisory committees.

Purpose. The purpose of the committee is to provide assistance to the board to establish a leadership role for the Texas Department of Health (department) in the support for and delivery of school health services.

The committee shall advise the board concerning:

the development of a data collection model to compile basic information about school health services in the state; and

relevant issues based on the data collected to coordinate and improve school health services including health promotion.

The committee shall carry out any other tasks given to the committee by the board.

Review and duration. By June 1, 2003, the board will initiate and complete a review of the committee to determine whether the committee should be continued, consolidated with another committee, or abolished. If the committee is not continued or consolidated, the committee shall be abolished on that date.

Composition. The committee shall be composed of 16 members appointed by the board as follows:

two physicians providing health services to school aged children;

two registered nurses or physician assistants providing school health services;

six consumer members including parents of school aged children and at least one parent of a special needs child;

two school administrators; and

four members representing organizations and/or agencies involved with the health of school children.

Terms of office. The term of office of each member shall be six years. Members shall serve after expiration of their term until a replacement is appointed.

Members shall be appointed for staggered terms so that the terms of a substantially equivalent number of members will expire on June 1 of each odd-numbered year beginning in 2001.

If a vacancy occurs, an individual shall be appointed to serve the unexpired portion of that term.

Officers. The chairman of the board shall appoint a presiding officer and an assistant presiding officer to begin serving on June 1 of each odd-numbered year.

Each officer shall serve until May 31 of each odd-numbered year. Each officer may holdover until his or her replacement is appointed by the chairman of the board.

The presiding officer shall preside at all committee meetings at which he or she is in attendance, call meetings in accordance with this section, appoint subcommittees of the committee as necessary, and cause proper reports to be made to the board. The presiding officer may serve as an ex-officio member of any subcommittee of the committee.

The assistant presiding officer shall perform the duties of the presiding officer in case of the absence or disability of the presiding officer. If the office of the presiding officer becomes vacant, the assistant presiding officer will serve until a successor is appointed to complete the unexpired portion of the term of the office of presiding officer.

If the office of assistant presiding officer becomes vacant, it may be filled temporarily by vote of the committee until a successor is appointed by the chairman of the board.

A member shall serve no more than two consecutive terms as presiding officer and/or assistant presiding officer.

The committee may reference its officers by other terms, such as chairperson and vice-chairperson.

Meetings. The committee shall meet at least twice each year.

A meeting may be called by agreement of Texas Department of Health (department) staff and either the presiding officer or at least three members of the committee.

Department staff shall make meeting arrangements and shall contact committee members to determine availability for a meeting date and place.

The committee is not a "governmental body" as defined in the Open Meetings Act. However, in order to promote public participation, each meeting of the committee shall be announced and conducted in accordance with the Open Meetings Act, Texas Government Code, Chapter 551, with the exception that the provisions allowing executive sessions shall not apply.

Each member of the committee shall be informed of a committee meeting at least five working days before the meeting.

Nine members of the committee shall constitute a quorum for the purpose of transacting official business.

The committee is authorized to transact official business only when in a legally constituted meeting with a quorum present.

The agenda for each committee meeting shall include an item entitled public comment under which any person will be allowed to address the committee on matters relating to committee business. The presiding officer may establish procedures for public comment, including a time limit on each comment.

Attendance. Members shall attend committee meetings as scheduled. Members shall attend meetings of subcommittees to which the member is assigned.

A member shall notify the presiding officer or appropriate department staff if he or she is unable to attend a scheduled meeting.

It is grounds for removal from the committee if a member cannot discharge the member's duties for a substantial part of the term for which the member is appointed because of illness or disability, is absent for more than half of the committee and subcommittee meetings during a calendar year, or is absent from at least three consecutive committee meetings.

The validity of an action of the committee is not affected by the fact that it is taken when a ground for removal of a member exists.

Staff. Department staff shall provide administrative support for the committee.

Procedures. Roberts Rules of Order, Newly Revised, shall be the basis of parliamentary decisions except where otherwise provided by law or rule.

Any committee action must be approved with a quorum present and by a majority vote of the members present.

Each member shall have one vote.

A member may not authorize another individual to represent the member by proxy.

The committee shall make decisions in the discharge of its duties without discrimination based on any person's race, creed, gender, religion, national origin, age, physical condition, or economic status.

Minutes of each committee meeting shall be taken by department staff.

A draft of the minutes approved by the presiding officer shall be provided to the board and each member of the committee within 30 days of each meeting.

After approval by the committee, the minutes shall be signed by the presiding officer.

Subcommittees. The committee may establish subcommittees as necessary to assist the committee in carrying out its duties.

The presiding officer shall appoint members of the committee to serve on subcommittees and to act as subcommittee chairpersons. The presiding officer may also appoint nonmembers of the committee to serve on subcommittees.

Subcommittees shall meet when called by the subcommittee chairperson or when so directed by the committee.

A subcommittee chairperson shall make regular reports to the committee at each of its meetings or in interim written reports as needed. The reports shall include an executive summary or minutes of each subcommittee meeting.

Statement by members.

The board, the department, and the committee shall not be bound in any way by any statement or action on the part of any committee member except when a statement or action is in pursuit of specific instructions from the board, department, or committee.

The committee and its members may not participate in legislative activity in the name of the board, the department, or the committee except with approval through the department's legislative process. Committee members are not prohibited from representing themselves or other entities in the legislative process.

Reports to board. The committee shall file an annual written report with the board.

The report shall list the meeting dates of the committee and any subcommittees, the attendance records of its members, a brief description of actions taken by the committee, a description of how the committee has accomplished the tasks given to the committee by the board, the status of any rules which were recommended by the committee to the board, and anticipated activities of the committee for the next year.

The report shall identify the costs related to the committee's existence, including the cost of agency staff time spent in support of the committee's activities.

The report shall cover the meetings and activities in the immediate preceding 12 months and shall be filed with the board each June. It shall be signed by the presiding officer and appropriate department staff.

Reimbursement for expenses. In accordance with the requirements set forth in the Government Code, Chapter 2110, a committee member may receive reimbursement for the member's expenses incurred for each day the member engages in official committee business if authorized by the General Appropriations Act or budget execution process.

No compensatory per diem shall be paid to committee members unless required by law.

A committee member who is an employee of a state agency, other than the department, may not receive reimbursement for expenses from the department.

A nonmember of the committee who is appointed to serve on a subcommittee may not receive reimbursement for expenses from the department.

Each member who is to be reimbursed for expenses shall submit to staff the member's receipts for expenses and any required official forms not later than 14 days after each committee meeting.

Requests for reimbursement of expenses shall be made on official state vouchers prepared by department staff.

This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority.

Filed with the Office of the Secretary of State on April 23, 1999.

General Counsel

Texas Department of Health

Effective date: May 13, 1999

Proposal publication date: January 29, 1999

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

Chapter 97. Communicable Diseases

Subchapter B. Immunization Requirements in Texas Elementary and Secondary Schools and Institutions of Higher Education

25 TAC §§97.63, 97.65, 97.67, 97.74

The Texas Department of Health (department) adopts amendments to §§97.63, 97.65, 97.67, and 97.74, concerning immunization requirements in Texas child-care facilities, elementary and secondary schools and institutions of higher education. Sections 97.63 and 97.67 are adopted with changes to the proposed text as published in the January 29, 1999, issue of the Texas Register (24 TexReg 494). Sections 97.65 and 97.74 are adopted without changes and therefore will not be republished.

These amendments implement departmental initiatives to enhance childhood protection against hepatitis A, hepatitis B, and varicella (chickenpox) and incorporate recent recommendations of the Advisory Committee on Immunization Practices (ACIP) for the vaccination of health care workers by requiring varicella vaccination for higher education students in the health professions whose work involves direct patient contact. Hepatitis A vaccination will be required in 32 border counties for children and students 2 years old and older who were born on or after September 2, 1992. The existing requirement for hepatitis B vaccination throughout the state will be expanded to include a cohort of adolescents. A new requirement for varicella vaccine for children entering kindergarten in Fall, 2000, and all younger children attending child-care; for 12 year-olds without a reliable history of varicella disease; and for higher education students without a reliable history of varicella disease, who are pursuing health professions degrees.

The following comments were received concerning the proposed rules. A total of 419 written communications were received. Following each comment is the department's response and any resulting changes.

Comment: Concerning the proposal in its entirety, 138 commenters concurred with the proposed changes and remarked that requirement of the proposed vaccines is in the best interest of Texas' children.

Response: The department appreciates the time these reviewers spent considering the proposed changes. No change was made as a result of the comments.

Comment: Concerning the proposal in its entirety, 5 commenters wrote the department to express their opposition to the proposed requirements, without making specific objection.

Response: The department appreciates the time these reviewers spent considering the proposed changes. Lack of a specific objection makes it impossible to address their concerns, but the department assumes they share the concerns as follows.

Comment: Concerning the proposal in its entirety, 3 commenters asked the department to reconsider the proposed additional requirements for varicella and hepatitis B vaccine, as they are an undue hardship for schools and school nurses.

Response: The department understands the concerns of these commenters, but feels the potential benefit to children necessitates the proposed additional requirements. No change was made as a result of these comments.

Comment: Concerning the proposal in its entirety, 1 commenter noted that this proposal would require significant amounts of funding and expressed concern that the department would not be able to implement the hepatitis B and varicella requirements statewide.

Response: The department agrees. New language has been added to §97.63(c) so that the implementation of hepatitis A, hepatitis B and varicella be dependent on funding. By July 1, 1999, the department will publish a statement on whether the rules change for hepatitis A, hepatitis B and varicella will be implemented.

Comment: Concerning the proposal in its entirety, 22 commenters stated that as parents, they rely on their physicians and the department for guidance as to appropriate preventive measures. They urged the Texas Board of Health (board) to support these required immunizations.

Response: The department appreciates the time these reviewers spent considering the proposed changes. No change was made as a result of these comments.

Comment: Concerning the proposal in its entirety, one commenter wrote that divorce is a consequence of a child becoming disabled or handicapped due to vaccination.

Response: The department neither agrees nor disagrees with this observation. No change was made as a result of these comments.

Comment: Concerning the proposal in its entirety, 9 commenters objected that these proposals represent an excess of state power and authority.

Response: The department disagrees with these comments. The legislature has granted the board of health statutory authority for the proposed changes. Some of the proposed changes are being made as the result of legislative intent. No change was made as a result of these comments.

Comment: Concerning the proposal in its entirety, one commenter accused the department of not advertising this proposal and concluded that the department was trying to "slip these mandates past the public."

Response: The department disagrees with this commenter. This proposal was published in the July 19, 1999, issue of the Texas Register, as required by law. The department solicited by mail comments of approximately 450 health agencies, school officials, public citizens, and interest groups, who were urged to share the information with other interested parties. This letter and its attachments were posted in the department's world-wide-web site, and announcements about the information posted on the web sites of other organizations, including the Texas Education Agency, the Texas Medical Association, and the Texas Osteopathic Medical Association. The large number of comments (over 400) on this proposal demonstrates that these efforts were successful. No change was made as a result of these comments.

Comment: Concerning the proposal in its entirety, 5 commenters likened these proposals to the discredited policies of various dictatorships.

Response: The department disagrees with these comments. No change was made as a result of these comments.

Comment: Concerning the proposal in its entirety, 3 commenters believe that school immunization requirements have broken the public trust and that the phenomenon will grow.

Response: The department disagrees and believes that school immunization requirements are supported by a majority of the public. No change was made as a result of these comments.

Comment: Concerning §97.63, 170 commenters who were opposed to the proposal noted that the vaccines in question (hepatitis A, hepatitis B, and varicella) are already available to any child in Texas whose parent wants them administered.

Response: The department agrees that these vaccines are available. Historically, however, availability of vaccines has not fully accomplished the department's goal of vaccine-preventable disease reduction. There is a direct correlation between vaccine mandates and both increased immunization levels and decreased disease incidence. Measles vaccine was licensed in 1963. There were 19,761 cases of measles reported in Texas that year, a relatively mild year. In 1964 there were 71,629 cases reported. Texas first required measles vaccine in 1971, when there were 8,495 cases reported. By 1974, there were only 212 cases reported. Incidence has never since approached the 1971 levels. In the national measles epidemic which occurred in 1989 and 1990, Texas reported 3,313 cases in 1989 and 4,409 in 1990. In 1991, Texas adopted the revised national recommendation for a second dose of measles vaccine at age 12. Texas celebrated its first measles-free year in 1998, and measles incidence is at an all-time low nationally. The department believes that immunization requirements have played an important role in achieving the historically low levels of vaccine-preventable disease experienced today. No change was made as a result of these comments.

Comment: Concerning §97.63, 10 commenters expressed the belief that these requirements were needed because some parents will not get their children immunized unless there is a requirement to do so.

Response: The department appreciates these commenters sharing their experience. No change was made as a result of these comments.

Comment: Concerning the proposal in its entirety, 2 commenters encouraged the department to consider scientific evidence, not anecdote, in its consideration of this proposal.

Response: The department agrees and assures the commenters that this is our policy. No change was made in response to these comments.

Comment: Concerning the proposal in its entirety, 156 commenters who were opposed to the proposal noted that it would make it illegal for a parent to delay or not give any of the vaccines in question (hepatitis A, hepatitis B, and varicella).

Response: The department disagrees that these changes alter the conditions under which a parent may delay or not give a vaccination. Exemption from the requirement for any of the vaccines in question can be obtained through the same means as are available for the vaccines which are currently required. These provisions are contained in 25 Texas Administrative Code §97.62, which is unchanged by this proposal. No change was made as a result of these comments.

Comment: Concerning §97.63, one commenter requested that the department include rotavirus vaccine in the requirements for children attending day-care facilities.

Response: The department appreciates the commenter's concern for children in day-care facilities. Rotavirus vaccine is not routinely available and is recommended only for the very youngest children (those 6 months of age or younger). The department may reconsider this issue in the future. No changes were made as a result of this comment.

Comment: Concerning §97.63, one commenter expressed concern that the new requirements would pose a hardship for parents relocating to Texas from other states which do not require the same immunizations.

Response: The department disagrees. While vaccine requirements are not uniform from state to state, they are similar. Current rules provide for children transferring to Texas schools from another state to attend school while continuing to receive required immunizations. No change was made in response to this comment.

Comment: Concerning §97.63, 45 commenters felt the proposed implementation date of August 1, 1999, did not allow time to assure compliance. Many noted that they would be unable to notify students of the new requirements, particularly incoming kindergarten students, who pre- register in the spring. The need to reprogram school computer systems was also cited as an obstacle to implementation on this date.

Response: The department agrees and has changed the implementation date for the new varicella and hepatitis B requirements to "no later than August 1, 2000." The department has also changed the birth dates in §97.63(c)(2)(F) (ii), §97.63(c)(2)(G)(i) and §97.63(c)(2)(G)(ii). These dates define the cohorts affected by the hepatitis B and varicella requirement, and must be changed as a result of the new implementation date. The department hopes this change accommodates many of the needs expressed by the commenters. However, because of the incidence of hepatitis A disease along the Texas-Mexico border, the requirement for that vaccine is still set to take effect on August 1, 1999. Many commenters from the affected area noted that this would not be difficult.

Comment: Concerning §97.63, one commenter from the Texas-Mexico border area felt that the proposed implementation date of August 1, 1999, did not allow time to assure compliance.

Response: The department agrees and has changed the implementation date to August 1, 2000. The department has contacted this commenter and offered its assistance in implementing the hepatitis A requirement. No further changes were made as a result of these comments.

Comment: Concerning §97.63, 42 commenters felt the proposed implementation date of August 1, 1999 did not allow time to assure compliance and requested that these changes not be implemented until August 1, 2000.

Response: The department agrees and has changed the implementation date to August 1, 2000. No further changes were made as a result of these comments.

Comment: Concerning §97.63, 15 commenters felt the proposed implementation date of August 1, 1999 did not allow time to assure compliance. Additionally, they requested that the department not make these changes effective during the school-year because once students are enrolled, it is difficult to enforce the requirements.

Response: The department agrees and has changed the implementation date to August 1, 2000. No further changes were made as a result of these comments.

Comment: Concerning §97.63, 25 commenters felt the proposed implementation date of August 1, 1999 did not allow time to assure compliance suggested that implementing hepatitis B and varicella at different times in the year 2000 to alleviate the burden.

Response: The department agrees in part and disagrees in part. The implementation date has been changed to August 1, 2000. The department hopes that this change will make simultaneous implementation of the new hepatitis B and varicella requirements less burdensome. The department's experience is that rule changes should be as infrequent as possible to minimize provider and school confusion and to maximize parental convenience. No further changes were made as a result of these comments.

Comment: Concerning §97.63, 39 commenters who were opposed to the proposal cited questions about the safety of vaccines as a cause of their concern. As evidence, some cited their own or others' experience with illness that they felt was caused by vaccination. Others stated that the vaccines in question are not covered by the National Vaccine Injury Compensation Program (VICP).

Response: The department agrees in part and disagrees in part. All medical procedures, including vaccination, carry with them a degree of risk. The department feels that the benefits of vaccination far exceed the potential risk. Vaccines have been shown to be very safe, as evidenced by the millions of people who have been vaccinated without incident. However, the department recognizes that rare adverse events can and do occur. The VICP covers all routinely recommended vaccines, including hepatitis B and varicella vaccines. These vaccines were included in 1997, with retroactive coverage extending eight years. In addition, an amendment to include any new vaccine recommended by the Centers for Disease Control and Prevention (CDC) for routine administration to children has been added. No change was made as a result of these comments.

Comment: Concerning §97.63(c)(2)(F)(ii), 29 commenters who were opposed to the proposal compared figures from the CDC on the incidence of hepatitis B illness among children who had not received hepatitis B vaccine to numbers (source unknown) of serious injuries and deaths occurring to children who had received hepatitis B vaccine.

Response: The department disagrees that the comparison is valid. The CDC estimates that only 10 percent of acute hepatitis B infections among children are clinically recognized and are likely to be reported. The department believes that the numbers of deaths and adverse events were derived from Vaccine Adverse Events Reporting System (VAERS) data. A VAERS report does not demonstrate causation and cannot be used to quantify the number of possible adverse events. A single incident may be reported by several persons. When the incident occurs following the administration of multiple vaccines, the incident is counted multiple times to account for the possibility that the incident cannot be temporally associated with any one of the vaccines administered. No change was made as a result of these comments.

Comment: Concerning §97.63(c)(1)(F)(vi) and §97.63(c)(2)(H), 28 commenters who were opposed to the proposal stated that hepatitis A is often mild in young children. Some stated that giving the hepatitis A vaccine could be more harmful (than the disease).

Response: The department agrees in part and disagrees in part. Although childhood infection is often very mild in young children, many school-aged children do experience symptoms. Children can play a significant role in the transmission of hepatitis A virus (HAV) to adults. Hepatitis A is more severe among adults and has a longer convalescent period. The department feels that the vaccine's safety and benefit to the community outweigh any small potential for risk. No change was made as a result of these comments.

Comment: Concerning §97.63(c)(1)(F)(vi) and §97.63(c)(2)(H), 27 commenters who were opposed to the proposal stated that hepatitis A can be prevented by clean water supplies.

Response: The department disagrees. Other means through which HAV can be spread include person-to-person contact and ingestion of contaminated food. A series of serosurveys were conducted in 1989 through 1998 among children living in U.S.-Mexico border counties. These surveys showed that the percent of children positive for HAV antibodies increases with age. This is not the pattern that would be expected if water were the sole source of infection. If that were the case, children would all become infected at a young age, at the time they first ingested contaminated water. The department believes that this epidemiology demonstrates that water is not the primary source of infection with HAV. No change was made as a result of these comments.

Comment: Concerning §97.63(c)(1)(F)(vi) and §97.63(c)(2)(H), 1 commenter stated that it was not "ethical or moral" to implement a hepatitis A requirement along the Texas-Mexico Border. She provided the department with a statement signed by 96 people who noted that they were unaware of any outbreak of hepatitis A in these counties. They concluded that the department was unfairly requiring minority children on the border to receive hepatitis A vaccine.

Response: The department disagrees. The selected counties were chosen because they report a highly disproportionate number of hepatitis A cases relative to their population size. Within these counties the requirement is imposed without regard to race or ethnicity. The incidence rates in this area meet federal standards for routine vaccination against hepatitis A. The department has been strongly encouraged by Hispanic political leaders to require hepatitis A vaccine in these border counties. No change was made as a result of this comment.

Comment: Concerning §97.63(c)(1)(F)(vi) and §97.63(c)(2)(H), 2 commenters (from Harris County) expressed hope that the proposed hepatitis A requirement for 32 border-counties would decrease the rate of hepatitis A in Harris County.

Response: The department shares their hope. No change was made as a result of these comments.

Comment: Concerning §97.63(c)(1)(F)(vi) and §97.63(c)(2)(H), 4 commenters requested that the hepatitis A requirement be extended to include their community/county or the entire state.

Response: The department appreciates their concern but disagrees that a statewide requirement for hepatitis A vaccine is needed at this time. Hepatitis A vaccine is available to county health departments through the Vaccines for Children Program when the rate of disease exceeds a certain level for an extended period of time. The department will continue to work with the jurisdictions that requested inclusion to assess their eligibility for the vaccine. No change was made as a result of this comment.

Comment: Concerning 97.63(c)(2)(F)(ii), one commenter raised the possibility that surface protein of the hepatitis B virus (HBV) has developed the ability to produce autoimmune diseases in some individuals and that this could also occur with the vaccine.

Response: The department acknowledges that vaccine safety is a concern. Expert panels which have reviewed the most current epidemiologic scientific evidence have not found support for this hypothesis and do not recommend any changes to current policy. No change was made as a result of these comments.

Comment: Concerning §97.63(c)(2)(F)(ii), one commenter asked if hepatitis B vaccine could be modified to prevent these adverse events (referenced in the previous comment).

Response: The department cannot comment on this question. Although vaccines have an excellent safety record, the department recognizes that rare adverse events can and do occur and welcomes any modifications that would decrease their frequency. No change was made as a result of these comments.

Comment: Concerning §97.63(c)(2)(F)(ii), one commenter asked if control of HBV should be accomplished by early treatment or other methods.

Response: The department notes that prenatal screening and subsequent treatment with immune globulin and vaccine protect infants born to the majority of hepatitis B infected women. However, no curative treatments currently exist for acute HBV infection and supportive and symptomatic care are the mainstays of therapy. No change was made as a result of these comments.

Comment: Concerning §97.63(c)(2)(F)(ii), one commenter asked if there was adequate justification for use of hepatitis B vaccine in newborn infants, citing research in animal models.

Response: The department cannot comment on the applicability of animal model-based research to human subjects, but feels that justification exists for routine infant immunization against hepatitis B. Hepatitis B vaccination of newborns has been shown to be safe and effective for full-term infants born to hepatitis B surface antigen (HBsAg) negative mothers. It has also been found to be safe and effective for newborns of HBsAg positive mothers. No change was made as a result of these comments.

Comment: Concerning §97.63(c)(2)(F)(ii), one commenter asked if sufficient documentation exists to justify routine vaccination of 12 year olds. The commenter requested that the department address: the duration of the vaccine's effectiveness; the percent of vaccine non- responders and how they would be accommodated by the requirement for serologic confirmation of immunity; and the risk of life-long disability among different population groups.

Response: The department feels that data exist which justify routine immunization of 12 year olds against hepatitis B, a recommendation which is supported by the Advisory Committee on Immunization Practices and the American Academy of Pediatrics. Even when post-vaccination antibody titers have fallen below detectable levels, no studies have reported acute symptomatic infection among initial responders. Studies to date show that the vaccine provides excellent long- term protection when administered as recommended. The department believes the commenter misunderstood the context in which serologic confirmation of immunity is required. Serologic confirmation may be required as an alternative to vaccination, but evidence of seroconversion following vaccination is not required. A review by the Food and Drug Administration of case reports from the Vaccine Adverse Events Reporting System for the years 1991 to 1994 concluded there were no unexpected adverse events in neonates and infants given hepatitis B vaccine, despite the use of at least 12 million doses of vaccine in these age groups. The department acknowledges the commenter's hypothesis that risks for adverse events vary among population groups but is not aware that such differences have been proven. No change was made as a result of this comment.

Comment: Concerning §97.67 (Verification of Immunity of Measles, Rubella, Mumps, Hepatitis A, Hepatitis B, or Varicella), 1 commenter noted that hepatitis A had not been added to the list of diseases for which vaccination was required if serologic proof of immunity was not available. Likewise, hepatitis A was not enumerated among the disease for which evidence of immunity was defined as consisting of a laboratory report.

Response: The department agrees and has amended the rules as suggested.

Comment: Concerning §97.63(c)(2)(F)(ii), 41 commenters who were opposed to the proposal noted that hepatitis B is spread through "irresponsible" behavior. Many objected to the department "placing a moral judgement" on their children by proposing to require hepatitis B vaccine for children and students in school and day-care.

Response: The department disagrees and responds that the legislature's desire that the department require hepatitis B vaccine is expressed in Chapter 386, Acts of the 74th Legislature. The department also disagrees that risk factors for hepatitis B involve only behaviors under the control of the individual. Hepatitis B is spread through contact with infected blood and body fluids. Intravenous drug use and unprotected sex account for a majority of cases, but these activities do not account for all cases, especially those which occur in young children. Hepatitis B vaccine protects any and all children from possible future exposures, no matter the cause or parental expectations. These facts and the legislative intent warranted no change as a result of these comments.

Comment: Concerning §97.63(c)(2)(F)(ii), which expands the requirement for hepatitis B vaccine to a cohort of 12 year olds, 2 commenters praised the department for utilizing the recently-increased resources to protect this group of students.

Response: The department appreciates the time these reviewers spent considering the proposed changes. No change was made as a result of these comments.

Comment: Concerning §97.63(c)(2)(F)(ii), 1 commenter stated that teenage pregnancy was a greater problem than hepatitis B and asked if the department plans to provide birth control for young girls.

Response: The department notes that this topic is outside the subject of these rules. No change was made as a result of this comment.

Comment: Concerning §97.63(c)(2)(F)(ii), which expands the requirement for hepatitis B vaccine to a cohort of 12 year olds, 1 commenter expressed concern that the department had underestimated the immediate cost to schools of the new requirement. Costs mentioned include nurse time to achieve compliance and increased absence due to exclusion for noncompliance. She does agree however, that the proposed requirement is justified, and in the future will prove cost effective.

Response: The department appreciates the commenter's acknowledgment that the long-term benefits of this change outweigh its immediate costs and hopes that the changed implementation date as described above will minimize the burden to school nurses. No change was made as a result of this comment.

Comment: Concerning §97.63(c)(1)(E)(v), §97.63(c)(2)(G), §97.63(c)(2)(G)(i)(I), and §97.63(c)(2)(G)(ii)(I), 40 commenters who were opposed to the proposal noted that varicella is a benign childhood illness that usually gives lifelong immunity. Some noted concern that vaccine-induced immunity would be temporary, putting children at risk of the disease in adulthood, when it is more severe.

Response: The department agrees in part and disagrees in part. Although varicella is usually a mild disease in healthy children, varicella is a contributory cause of death for several Texans each year. A review of 1997 Texas death certificates revealed 8 deaths (4 children and 4 adults) in which varicella was an immediate or contributing cause of death. Varicella deaths are often related to secondary infection and may not be captured by review of death certificate data. For example, the death of 1 child caused by group A streptococcus (GAS) septicemia and pneumonia following varicella infection was recorded by the department during a 1997 GAS outbreak investigation. In addition to reducing disease among children, other age groups would benefit by decreased exposure to varicella.

It is not possible to state with certainty the duration of protection provided by any new vaccine. However, longer experience with other live viral vaccines (e.g. measles, rubella) has shown no evidence of waning immunity in a population. In the past, when recommendations for additional doses of live-virus vaccines have been made, it has been to protect the small percent of people who fail to respond to the first dose (primary vaccine failure), rather than because immunity has waned. Follow-up data from pre-licensure clinical trials in Japan indicate that protection from varicella vaccine lasts for at least 20 years. American clinical trials (begun later) demonstrate lasting immunity for 11 years to-date. These studies are ongoing. No change was made as a result of these comments.

Comment: Concerning §97.63(c)(1)(E)(v), §97.63(c)(2)(G), §97.63(c)(2)(G)(i)(I), and §97.63(c)(2)(G)(ii)(I), 51 commenters shared their experience or professional observations of varicella disease. Many were parents who noted that this experience had changed their belief that varicella was "no big deal."

Response: The department appreciates these commenters sharing their experience. No change was made as a result of these comments.

Comment: Concerning the proposed preamble, 35 commenters who were opposed to the proposal objected to the department's statement that work disruptions were a significant consideration in estimating the societal cost of varicella illness. The stated objection was that it was not the function of a health agency to determine how much work parents are allowed to miss to care for sick children. Many noted that this would not be a hardship for their family because one parent was not in the work-force or because their children were home-schooled.

Response: The department disagrees and notes that the intended effect of the proposed change is to prevent vaccine-preventable diseases, their complications and consequences. In considering the consequence of lost work-time for parents, the department recognizes that some parents suffer financial consequences when they must care for sick children. No change was made as a result of these comments.

Comment: Concerning §97.63(c)(1)(E)(v), §97.63(c)(2)(G), §97.63(c)(2)(G)(i)(I), and §97.63(c)(2)(G)(ii)(I), 2 commenters noted that the cell-line from which varicella vaccine is manufactured was developed using fetal tissue. They stated that they found this link to the "abortion industry," to be morally objectionable.

Response: The department notes that the cell lines from which the vaccine is cultured have been growing under laboratory conditions 30 years or longer. Neither cell line requires additional fetal tissue for the manufacture of vaccine. No change was made as a result of these comments.

Comment: Concerning §97.63(c)(2)(G)(i)(I) and §97.63(c)(2)(G)(ii)(I), program staff noted that 2 doses of varicella vaccine are recommended for susceptible persons 13 years old and older. Students who do not show proof of having received 1 dose of varicella vaccine by their 13th birthday (such as transfer students from other states) must have 2 doses of vaccine to insure adequate immunity. As proposed, the rules do not require 2 doses for such people.

Response: The department agrees and has amended the rules as suggested.

Comment: Concerning §97.63(c)(2)(G), 4 commenters requested that all children be included in the varicella vaccine requirement and not just children in the age groups proposed. The point was made that anyone at risk of the disease is subject to its consequences, and should be protected.

Response: The department shares this concern, but funding does not permit expansion of the requirement at this time. It is also noted that as proposed, the requirement minimizes the administrative burden to school nurses by establishing new requirements at the same ages as other existing ones. No change was made as a result of this comment.

Comment: Concerning §97.63(c)(2)(G)(i)(I) and §97.63(c)(2)(G)(ii)(I), 14 commenters thought that the storage and handling requirements of varicella vaccine would make it difficult to administer at mobile clinics and that this would be an obstacle to compliance. A question was also raised about the ability of local health departments and physicians to stock the vaccine in sufficient quantity, since the procedures for ordering this vaccine are different from other vaccines covered by the Vaccines for Children Program.

Response: The department agrees in part and disagrees in part. The department believes that initial problems with ordering and shipping the vaccine to local health departments and physicians has been resolved, but the department's pharmacy and the Immunization Division Vaccine Accounting section will continue to address any issues that are brought to their attention. These divisions will continue to publicize ways that the vaccine may be safely transported to mobile clinics and will offer assistance in supplying dry ice in parts of the state which do not have a ready resource. No change was made in response to these comments.

Comment: Concerning §97.63(c)(1)(E)(v), §97.63(c)(2)(G), §97.63(c)(2)(G)(i)(I), and §97.63(c)(2)(G)(ii)(I), 2 commenters expressed doubt about the effectiveness of varicella vaccine. One cited incidence of varicella illness in previously vaccinated children as evidence.

Response: The department feels that the efficacy of the vaccine was convincingly demonstrated in clinical trials, where 97 percent of children vaccinated between 12 months and 12 years of age developed detectable varicella antibodies within 4 to 6 weeks of vaccination. Clinical trials also demonstrated a 77 percent reduction among vaccinees in the number of expected cases of chickenpox following household exposure. Even when breakthrough illness occurs, the varicella illness is milder than among unvaccinated children. This means that such children are at lower risk of complications from the disease than are unvaccinated children. No change was made as a result of these comments.

Comment: Concerning §97.63(c)(1)(E)(v), §97.63(c)(2)(G), §97.63(c)(2)(G)(i)(I), and §97.63(c)(2)(G)(ii)(I), 2 commenters noted that the proposed varicella vaccine requirement would protect school employees who were not infected as children. As adults, this occupational exposure poses risk of severe morbidity.

Response: The department agrees with this observation. No change was made as a result of these comments.

Comment: Concerning §97.63(c)(2)(G)(i)(I) and §97.63(c)(2)(G)(ii)(I), 1 commenter requested that the department require varicella vaccine (or a parent letter or doctor's note) only of the children in pre-kindergarten and kindergarten. She felt that it would be difficult to achieve compliance among her total school population.

Response: Vaccine (or parent letter or doctor's note ) is not proposed to be required of the entire school enrollment, only those students affected by the rule. The department has clarified this with the commenter. No change was made as a result of this comment.

Comment: Concerning §97.63(c)(1)(E)(iv), 1 commenter requested that a definition of "primary series and a booster" for Haemophilus influenzae type b (Hib) vaccine be provided for the benefit of school nurses and child-care facility employees. The definition supplied was: "at least 3 doses with 1 dose on or after the first birthday and at least 2 months following the previous dose, OR 2 doses after the first birthday and at least 2 months apart."

Response: The Hib vaccine schedule varies among manufacturers and depends on the age at which vaccination is initiated. When interpretation is required, the department advises school nurses and child-care facility employees to define it as the commenter has suggested, because that is the minimum required by the least restrictive combination of manufacturer and age at vaccination. No change was made as a result of this comment.

Comment: Concerning §97.63(c)(2)(C)(ii), §97.63(c)(2)(C)(iii)(I)(-a-), §97.63(c)(2)(C)(iii)(II)(-a-), and §97.63(c)(3)(E)(i)(I), 4 commenters noted that the requirement that doses of measles vaccine be received at least 30 days apart was inconsistent with a recent statement of the Advisory Committee on Immunization Practices. That statement says that the doses should be "separated by at least one month (i.e. a minimum of 28 days)."

Response: The department agrees and has implemented the suggestion. It is the department's intent that children who are vaccinated as recommended be in compliance with the requirements. In each place where the interval between doses is referenced, "28 days" has been substituted for "30 days."

Comment: Concerning §97.63(c)(2)(F)(ii) and §97.63(c)(2)(G)(ii), which require that proof of hepatitis B vaccine and varicella vaccine be shown at the 12th birthday, 1 commenter noted that another (existing) requirement calls for students to show proof of measles vaccination by 30 days after the 12th birthday. She suggested that the new requirement would be easier to administer if the requirements were synchronized.

Response: The department agrees and has amended the proposed rules to require proof of hepatitis B and varicella vaccines at 30 days after the 12th birthday, instead of at the time of their 12th birthday.

Comment: Concerning §97.63(c)(2)(F)(ii) and §97.63(c)(2)(G)(ii), one commenter asked the department to reconsider requiring varicella and hepatitis B vaccine for all students under age 13, because of the resources required to vaccinate the large number of students affected.

Response: The department sympathizes with the concerns of the commenter, but notes that all students under 13 would not be affected simultaneously. The department has clarified this in its reply to the commenter. Student records are presently reviewed at the time the student turns 12. Hepatitis B and varicella vaccines would be added to the list of immunizations reviewed at that time. No change was made as a result of these comments.

Comment: Concerning §97.63(c)(2)(F)(ii) and §97.63(c)(2)(G)(ii), one commenter questioned the number of vaccines to be given at age 12 and requested information from the Centers for Disease Control and Prevention or the Advisory Committee on Immunization Practice stating why this was chosen as the target age.

Response: The department has provided information from this organization which recommends that children be vaccinated at age 12 against measles-mumps-rubella (MMR), hepatitis B, and varicella only if the vaccines have not been previously received as recommended. No change was made as a result of this comment.

Comment: Concerning §97.63(c)(2)(F)(ii) and §97.63(c)(2)(G)(ii), one commenter requested that hepatitis B vaccine and varicella vaccine be required upon entry to 6th grade, rather than by 30 days after the 12th birthday.

Response: The department disagrees. The vaccine recommendations on which the requirements are based are based on chronologic age. The department feels that if the requirements were made dependent on an administrative category, such as grade, that children of many different ages would be affected. For some vaccinations, this would change the number of doses medically required to assure immunity. No change was made as a result of these comments.

Comment: Concerning §97.67 (Verification of Immunity of Measles, Rubella, Mumps, Hepatitis A, Hepatitis B, or Varicella), 10 commenters expressed concern about the validity of parental histories of prior varicella illness. Some noted that it would be confusing to parents to be allowed to provide history of this disease, but not for other diseases. Others felt the ease of writing this statement would encourage parents to falsify a disease history.

Response: The department understands that some parental histories of prior varicella illness will be incorrect. However, the Advisory Committee on Immunization Practices (ACIP) has determined that most parents are able to identify varicella because of its distinctive characteristics. This seems preferable to requiring large numbers of students who have already had chickenpox to go to the inconvenience and expense of serologic testing. The department anticipates requiring serologic evidence of infection in the future, as varicella becomes a less common (and less easily recognized) illness. No change was made as a result of these comments.

Comment: Concerning §97.67 (Verification of Immunity of Measles, Rubella, Mumps, Hepatitis A, Hepatitis B, or Varicella), 2 commenters noted that the requirement for 12 year-olds to be vaccinated against varicella would result in few children being vaccinated, since so many would already have had the disease. One commenter stated that nurses could use their limited time in ways that would be of greater benefit to student health.

Response: The department disagrees. Studies estimate that 10 percent of students remain susceptible to varicella at age 12. While sympathetic to the many demands on school nurses' time, the department feels that identifying and vaccinating these students is a high priority because of the greater severity of varicella disease when it is contracted by older children and adults. No change was made as a result of these comments.

Comment: Concerning §97.67 (Verification of Immunity of Measles, Rubella, Mumps, Hepatitis A, Hepatitis B, or Varicella), 3 commenters requested that records kept by school nurses also be accepted as documentation of varicella illness. These records would be based on observations made by the nurse or a report from the registrar that chickenpox was the reason for a child's absence.

Response: The department agrees that this is reasonable and has added language to §97.67 to allow school nurses to document parental reports of contemporaneous illness or to identify contemporaneous varicella illness they observe.

Comment: Concerning §97.67 (Verification of Immunity of Measles, Rubella, Mumps, Hepatitis A, Hepatitis B, or Varicella), 2 commenters suggested that the department develop a uniform statement for the parents to complete.

Response: The department agrees that this will be a useful tool for school nurses and will develop such a statement or form. No change was made in response to these comments.

Comment: Concerning §97.67 (Verification of Immunity of Measles, Rubella, Mumps, Hepatitis A, Hepatitis B, or Varicella), 11 commenters were concerned about the paperwork involved in documenting previous varicella illness. Some questioned the need to maintain a copy of the parent or physician statement of prior varicella illness, once it is entered into their computer system. Some were under the impression that the statement would have to be physically attached to the immunization record.

Response: The department has made changes to this section to clarify that schools are not required to physically attach these statements to the health card, but only to keep the information on file. It remains the responsibility of the school district to assure the accuracy of this information.

Comment: Concerning §97.67 (Verification of Immunity of Measles, Rubella, Mumps, Hepatitis A, Hepatitis B, or Varicella), 1 commenter requested that clinics/physicians/primary care providers be made responsible for maintaining documentation of previous varicella illness. She felt this was properly their responsibility, not that of school nurses.

Response: The department agrees in part and disagrees in part. Physicians document varicella illness as part of the medical record. For this reason, they are listed as a source of this information for school nurses. To assist them in locating that information, the department is including a place to record previous varicella illness on revisions of the immunization cards it supplies for use in providers' offices. However, the requirement that school nurses also record this information is consistent with their maintaining a copy of students' immunization histories. Such a history of necessity includes reasons for which a child may not require vaccination, such as a history of previous illness. No change was made in response to this comment.

Comment: Concerning §97.74, a commenter expressed concern that physician statements and laboratory reports would no longer be acceptable evidence of prior measles infection. He stated that this was the only evidence he was comfortable accepting and that he was not comfortable accepting a parent's statement as an alternative.

Response: The department believes this commenter misunderstood the context in which this change was proposed. This change does not make parental statements acceptable evidence of prior measles illness. In March 1997, laboratory confirmation was made the only acceptable evidence of prior measles or mumps illness. At this time, the reference to physician statements should have been deleted, but was not. No change was made in response to this comment.

The commenters were: Loren Adair; Richard Adams, MD for Dallas Public Schools; Kelly Adams; Delores Adler, RN; Sharron Albertson; Linda Alcarta, RN; Kate Anderson; Maryanne Anderson, RN; Brewster Andrews; Isla Andrews; Cindy Arnold; Sherry Arrick, John Asbury, MD; Tracy Avallone; Candy Bahr; Gladys Baker, MSN, RN; Rosanna Baldwin, RN; Terry Bankhead; Sheryl Barnes; Kristina Barnhart; Bill Batchelor; Kathy Bateman; Connie Bearfield; Keith Bechly; Stephen Benold, MD for Texas Academy of Family Physicians; Bridgette Berkes and Mark Ballard; Denise Bernd; Steven Bernd; Lisa Besserer; Maggie Bickley, RN; Judie Boothe; Tanya Boyd, RN; Latene Brackett; Shannon Brame; Becky Brawley, RN, BSN; Sandra Bridges, RN, PhD; Avalon Bruce, MPH; Frances A. Brunworth; Robert W. Bueker, CPA; Cene Burrow; Vince Butler; Penny Davis Cambere, MD; Christine Casales; Faith Casperson, RN for Conroe ISD; Beverly Cheatham, RN; Terry Clampett; Lewis M. Clark; Lisa Clark; Peggy Clark; Rhonda Clark; Sherri Clark; Joy Cobb, RN, MSN; Julie Coker and Michael Kisselburgh; Cheryl Coldwater, MD; Daniel Coleman; Lynda Contrucci, RN; Austin Cooney, PhD; Terry Copeland; Nancy Couch; Lynda Coursey; Judy Covey, RN; Clifford Craven, MD; Chris Crosby; Cheri Crow; Emily Croy; Diane Cunningham; Kellie Curtis; Terry Dailey; Ruth Dandalides; Juanita Dangel; Norma Daniel, RN; Joyce Dare; Glenn and Karen Davidenko; Katrina Davis; Lynne Davis; Maurice Davis; Robert Davis; Pamela Daviscourt; Donna Dawson, RN; Denise DeLisle; Richard DeLong; Cindy Diaz, RN; Margaret Dismukes; Gwen Dods, RN; Heather Dolan; Perry and Michele Doles; Karen Doran; Rod Douglas; Gabrielle Doyle; Susie Duggins; Vincy Dunn, RN, MSN; Lisa Duty; Lupita Gladis Perez Elizondo; Rose Emerson; Tammy K. Enzor; Terri Erwin; Albert Esparsen II, MPA; Judy Evans, RN; Donna L. Evans, MPH; William Fausett, DC; Kathy Fechtman; Alan H. Feldman, DD, DA Hom; Jaime E. Fergie, MD, FAAP; Jill Field, RN; Thomas and Grace Fisher; Victor and Elza Fisher; Stephanie Ford, MS, RN, CPNP; Cheryl Fostel; D.M. Foulds, MD; Patrice Fuqua, RN; Catherine Ganiron, RN; Danny Lee Garcia; Lisa Ann Garcia; Vickey Gay; Belinda Gelhausen; Sherry George; Kathryn E. Gin; Patrick K. Gin; Angela Girlinghouse; Mattye Glass; Janet Green; Judith Greilich; D. Greisinger; Gary Guiffre; Amy Guinn; Martin Hajovsky and Theresa Gregory; Genita Hall; Rose Hammer; I. Celine Hanson, MD; Alesha Harcourt, RN; Leslie Hardin; Brad Harrelson; Lorie Harrelson; Kristi Harvey, MD; Martha Haynes, RN; Charles Headley, RN; Angela Hendricks; Judy Gay Herman; Anne Higgins, RN; Harold Higgins; Joyce Hill; Todd Himmel; Marguerite Hirsch, RN; Brenda Hock, MS, RN, CPNP; Selena Hodgdon, RN; Robert Hoffman; Jon D. Holzheimer; JoAnn Hooper, RN; Carol S. Horan, RN, MSN; Dr. Robert Howell; Roxanne Huffman; Ruth Huffman; Nancy Hughes; Connie Hunt, RN; Judith Hunter, RN, MSN; B. Jane Hursey, MD; Barbara Jeffries, RN; Ayanna Jones; D.A. Jones; Julie A. Jones, MD, MPH; Michelle Jones; Peggy Jennings, RN; Hal. B. Jenson, MD; Suzanne Johnson; Carl and Kathy Kastner; Karen C. Kemper, MD; Joe Kilpatrick; James and Tina King; Ruth Kline; Art and Bridget Kline; Beth Knapp, MS, RN, CPNP; Karl Knight; Patsy Knight; Drue Kohler; Felix Koo, MD, PhD; Mary Jo Koss, RN; Kris Kriofske; Walter Kuhl, MD; Danny Kumamoto; Edalani Lacar, MD; Sharon LaMontagne, RN; Richard M. Lampe, MD; Kathy Langas; Marc Langas; Frances Langston, RN; Linda Langston, RN; Karen Lanier; Stephana Laws; Daniel Lee; Leah Leissner; Pam Lerette, RN; Mark C. Lesko, DC; Freda Levinson, RN.C, MBA, CNA, CSN; Lisa Lewis; Katherine Lin; Nathan Lindell; Debra Lochtrog-Swindle, RN; Marion London, RN; Mauri Long; Lori Looka, CPNP; Sherri Loose; Sarah Lowe; Angela Lubs; Ken Luce; Nancy Luce; Glenda Luedecker, RN; Laura Lyon; Angela Mager, RN; Jody Mansee, RN; Stephanie Marchbanks; Marilyn Marcontel, RN, CNA for Dallas Public Schools; Peg Marquart, RN; Mindy Mashburn, RN, MSN, CPNP and Bonnae Nawara, RN, MSN, CPNP, representing the Texas Chapter of National Association of Pediatric Nurse Associates and Practitioners; Paula Mashek, RN, MAL, CSN; C. Richard Massey, MD; Deborah Masterson; Kathleen Mauldin; Camellia May; Becky Mayod; Marsha McBride; David McClellan, Kathy McConnell, RN; Laura McWilliams; Kimberly Merenda; Julie Metzger; Alice Miller; Pamella Miller, RN; Joan Millican, RN; MaryClare Milner; Nancy and Michael Misner; Linn Monherud, RN; Ira Montgomery; Claudia Moore; Douglas Moore; Pat Moore, RN; Shirley Moreland, RN, CSN; Bernia Morris; Becky Mouser, MD; Nagla Moussa and Alvin Crofts; Alison Mullins; Gregory Mullins; Leslie Murphy RN; Marcy Murphy; Harriet Murray, RN; Wanda Myers; Linda Nayfa; Roger and Shirley Neal; Janet Neath; Donald K. Nelms, MD, FAAP; Annette Nelson; Keila Nichols, DC; Linda Niehues, RNC; Paul Ochoa; Mr. and Mrs. R. David Oltrogge; Joyce Olvera, RN; Christine Orbin; Mike and Kristina Ormond; Linda Owens; Susan Owens; Candy Parrott, RN, CPNP; Mary Peliter; Desiree Pendergrass; Janice Penson; Rosie Perez, RN; William Perez; D. Perry; David E. Phipps, DC; Jeffrey D. Pick, R.Ph, DC; Teresa Pick; Martha Poole, RN; Tonya Porter; Lesley Potof, BS, RN; D. Potts, Jr; Nicole Potts; Kristin Powers; Kerwin Price; Sharon Proctor; Pat Pruett, RN; Tracy Pulaski for Dallas County Medical Society and Dallas Area Infant Immunization Coalition; Katie Pulliam; Jason Pulliam; Liz Ramos; Mary Rampley, RN, BSN; Kristin Ray; David Reece; Nancy Reeve; Karen Remick; Laura Reude, MLS; Rebecca Rex; Dawn Richardson; Douglas and Kevin Sue Riddle; Jane Rider, MD; Autumn Rinewalt; Janice Rinewalt; Vicky Rister, RN; Sheryl Ritchie, BS, RN; Debbie Roberson, BS, MSN; Kristin Robertson; Leah Robertson; Mary Robertson; Darla Robinson, RN; Jerry Robinson, MPA for City of Laredo Health Department; R. Rohlin; D. Rosenberger, RN, BSN; Debra Roundy; Kip Ruhl, RN; Stephanie Ruiz; Tiffany Rumbo; Julia Russell; Daniel and Terri Ryan; Ana Salinas, RN; Yvette Salinas for Cameron County Health Department; Valerie A. Sauser, DC; Doreen Schaefer; Suzanne Scheller, RN, MSN, CNS; Joseph H. Schneider, MD; Sue Schrowang; Anatar and Aleena Schubert; Lynn Scoggins; Christopher Scott; Alice Seaton, MD; L. Seim; Anh Selissem; Patrick Shaffer; Diana Shultz; Sheri Skinner; Barbara Sommer, RN; Rene Sorenson; Susan Spana, RN; Michael Speer, MD; Judi J. Spencer; Stacy Spitzmuller, RN; D. Smith; Charlotte Stackburger, RN; Tana L. Stampes; Gwen Stone, RN, BSN, CSN; Beth Stribling; Kelly Stribling Sutherland; Pat Starodub, RN; Connie Stringer; Libby Stripling, RN; Cynthia Stuart; Milton W. Talbot, Jr, MD; James Taylor (1); James Taylor (2); Olla Theimer; Michele Thomas; Jackie Thompson; Joan Thompson; Karen Thompson; Laura Thompson, RN; Linda Thompson, FNP; SusanThompson, RN; Claire Timberlake-Bacani; Leanne Timura; Gayle Y. Treadwell; Carolyn Trochesset, RN; Debbi True; Sharon Turley, RN; Mary Jane Turner; Tx School Alliance; L. Vanaman, RN; Michelle Vanek; Velia Vasquez, RN; Nancy Vasut, RN; Patsy Vaughan, RN; Linda May Vierra; G. Wacker, RN; Karen Walters; Dharla Wall; Russell and Mireya Warren; Lisa Watkins; Judy Watson, RN; Beverly J. Weaver for Dallas Department of Environmental and Health Services; Janice Weikel; Michael K. Weir, MD; Leonard E. Weisman, MD; Diana Welborn; Carrol H. Wells; Galena Wertz; Alan White, MD; Sherry White, RN; Jeanne Wilcox; P. Wile, RN; Jan Wilkerson, RN; Barbara Williams; Rogers Williams; Toni Williams; Barbara Willingham; Pam Willman; Elizabeth Wills; Angie Wilson; Jim Wilson; Debra Wilsterman, RN; George Ann Windham RN, CPNP; Jean Woodman, MD; Lisa Wright; Jennifer F. Zea; Mae Zook.

The comments received were of three types. One group, composed primarily of parents, chiropracters and other private citizens, opposed the rules entirely. A second group, composed primarily of school nurses and other education officials supported the proposed requirements, but felt that the implementation date was unrealistic. A third group, composed primarily of parents, public health officials, physicians, and physician-organizations, supported the rules as proposed.

These amendments are adopted under Health and Safety Code §81.023 and §161.004, which require the Board of Health (board) to develop immunization requirements for children; Education Code §38.001, which allows the board to develop immunization requirements for admission to any elementary or secodary school; Education Code §51.933, which allows the board to develop immunization requirements for students at any institution of higher education who are pursuing a course of study in a health profession; Human Resources Code §42.043, which requires the department to make rules regarding the immunization of children admitted to day-care facilities; and Health and Safety Code §12.001, which provides the board with the authority to adopt rules for the performance of every duty imposed by law on the board, the department and the Commissioner of Health.

§97.63.Required Immunizations.

The following immunizations are required in the respective age groupings. A child or student must meet all the immunization requirements specific to an age group upon first entering the age group. Implementation of requirements for hepatitis B vaccine for adolescents and varicella vaccine and hepatitis A for all ages is contingent upon the appropriation of funds to the department for these purposes. By July 1 of each odd-numbered year, the department will publish a statement on whether or not these vaccines have been funded and are required as specified.

Children less than five years of age: polio vaccine; diphtheria-tetanus-pertussis (DTP) or diphtheria-tetanus-acellular pertussis (DTaP) vaccine; measles, mumps, and rubella vaccine (MMR); Haemophilus influenzae type b conjugate vaccine (HibCV), hepatitis A, and varicella vaccine.

Children 12 months of age, but not yet 15 months of age (12 months through 14 months of age):

one dose of MMR vaccine is required. Only doses received on or after the first birthday will meet this requirement. Serologic confirmation of measles, mumps, or rubella immunity or serologic evidence of infection is acceptable in lieu of vaccination for that disease only. For further information see §97.67 of this title (relating to Verification of Immunity to Measles, Rubella, Mumps, Hepatitis A, Hepatitis B, or Varicella; and

no later then August 1, 2000, one dose of varicella vaccine is required. This vaccine must have been received on or after the first birthday. A parent- or physician-validated history of varicella illness (chickenpox) or serologic confirmation of varicella immunity is acceptable in lieu of vaccine. For further information, see §97.67 of this title.

Children 15 months of age, but not yet 5 years of age (15 months through four years of age):

no later then August 1, 2000, one dose of varicella vaccine is required. This vaccine must have been received on or after the first birthday. A parent- or physician-validated history of varicella illness (chickenpox) or serologic confirmation of varicella immunity is acceptable in lieu of vaccine. For further information, see §97.67 of this title; and

no later then August 1, 2000, children subject to these requirements as described in §97.61 (relating to Children and Students Included in Requirements) must comply with the following requirement for hepatitis A vaccine if the facility, school or institution attended is located in any of the following counties: Brewster, Brooks, Cameron, Crockett, Culberson, Dimmitt, Duval, Edwards, El Paso, Frio, Hidalgo, Hudspeth, Jeff Davis, Jim Hogg, Kenedy, Kinney, La Salle, Maverick, McMullen, Pecos, Presidio, Real, Reeves, Starr, Sutton, Terrell, Uvalde, Val Verde, Webb, Willacy, Zapata, and Zavala. Serologic confirmation of immunity to hepatitis A or serologic evidence of infection is acceptable in lieu of vaccine. For further information, see §97.67 of this title. Doses of hepatitis A vaccine are required as follows:

children 2 years of age but not yet 3 years of age are required to show proof by 30 days past their second birthday of one dose of hepatitis A vaccine administered on or after their second birthday; and

children 3 years of age but not yet 5 years of age are required to have received two doses of hepatitis A vaccine administered on or after their second birthday.

Children and students five years of age or older.

Beginning January 1, 1991, children and students born on or after September 1, 1978 will be required to show serologic proof of measles immunity, serologic evidence of infection, or receipt of two doses of measles vaccine administered on or after the first birthday. This proof is not required until the child's 12th birthday. The two doses of measles vaccine must have been administered at least 28 days apart. Children and students may have 30 days past their 12th birthday to be in compliance with this clause. For further information see §97.65 of this title and §97.67 of this title.

Effective August 1, 1997:

children born on or after September 2, 1991, will be required to show proof of either:

two doses of measles vaccine administered on or after the first birthday and at least 28 days apart; or

children born prior to September 2, 1991 will be required to show proof by 30 days past their 12th birthday of either:

two doses of measles vaccine administered on or after the first birthday and at least 28 days apart; or

Effective August 1, 1998, children born on or after September 2, 1992, will be required to show proof of either:

three doses of hepatitis B vaccine; or

serologic confirmation of immunity to hepatitis B or serologic evidence of infection. For further information see §97.67 of this title.

No later then August 1, 2000, children born on or after September 2, 1988, but before September 2, 1992 will be required to show proof by 30 days past their 12th birthday of either:

three doses of hepatitis B vaccine; or

serologic confirmation of immunity to hepatitis B or serologic evidence of infection. For further information see §97.67 of this title.

No later then August 1, 2000, children born on or after September 2, 1994, will be required to show proof of either:

one dose of varicella vaccine received on or after the first birthday (two doses are required if the child is 13 years old or older at the time the first dose of varicella vaccine is received); or

a parent- or physician-validated history of varicella illness (chickenpox) or serologic confirmation of varicella immunity. For further information, see §97.67 of this title.

No later than August 1, 2000, children born on or after September 2, 1988, but before September 2, 1994, will be required to show proof by 30 days past their 12th birthday of either:

one dose of varicella vaccine received on or after the first birthday (two doses are required if the child is 13 years old or older at the time the first dose of varicella vaccine is received); or

a parent- or physician-validated history of varicella illness (chickenpox) or serologic confirmation of varicella immunity. For further information, see §97.67 of this title.

Hepatitis A. Effective August 1, 1999, children subject to these requirements as described in §97.61 of this title (relating to Children and Students Included in Requirements) must comply with the following requirement for hepatitis A vaccine if the facility, school or institution attended is located in any of the following counties: Brewster, Brooks, Cameron, Crockett, Culberson, Dimmitt, Duval, Edwards, El Paso, Frio, Hidalgo, Hudspeth, Jeff Davis, Jim Hogg, Kenedy, Kinney, La Salle, Maverick, McMullen, Pecos, Presidio, Real, Reeves, Starr, Sutton, Terrell, Uvalde, Val Verde, Webb, Willacy, Zapata, and Zavala. Serologic confirmation of immunity to hepatitis A or serologic evidence of infection is acceptable in lieu of vaccine. For further information, see §97.67 of this title. Children and students born on or after September 2, 1992, will be required to have received two doses of hepatitis A vaccine administered on or after their second birthday.

Students in institutions of higher education (colleges, universities, and other teaching facilities above the high school level).

Measles. Beginning January 1, 1992:

all students defined previously in subparagraph (A) of this paragraph who were born on or after January 1, 1957, must show proof of either:

two doses of measles vaccine administered since January 1, 1968, and on or after their first birthday and at least 28 days apart; or

Varicella. Beginning August 1, 1999, varicella vaccine is required of medical interns, residents, fellows, and students enrolled in health-related courses as defined in subparagraph (A) of this paragraph. One dose of vaccine is required for students who received this vaccine prior to 13 years of age; two doses are required for students who were not vaccinated before their thirteenth birthday. All doses of this vaccine must have been received on or after the first birthday. A history of varicella illness (chickenpox) validated by the student, the student's parent or the student's physician or serologic confirmation of varicella immunity is acceptable in lieu of vaccine. For further information, see §97.67 of this title.

§97.67.Verification of Immunity to Measles, Rubella, Mumps, Hepatitis A, Hepatitis B, or Varicella.

Section 97.63 of this title (relating to Required Immunizations) states that serologic confirmation of immunity to measles, rubella, mumps, hepatitis A, or hepatitis B are acceptable in lieu of vaccine against the serologically confirmed disease. If a child or student is unable to submit serological proof of immunity or serologic evidence of infection, then measles, rubella, mumps, hepatitis A, or hepatitis B vaccine is required. Evidence of measles, rubella, mumps, hepatitis A, or hepatitis B illnesses must consist of a laboratory report indicating confirmation of immunity or confirmation of infection. The school shall accurately record the results of any serologic tests supplied as proof of immunity. The original should be returned to the child/student or the child's/student's parent or guardian. All histories of varicella illness must be supported by a written statement from a physician or the child's/student's parent or guardian containing wording such as: "This is to verify that (name of student) had varicella disease (chickenpox) on or about (date) and does not need varicella vaccine." or by serologic confirmation of varicella immunity. School nurses may also write this statement to document cases of chickenpox that they observe. The school shall accurately record the existence of any statements attesting to previous varicella illness or the results of any serologic tests supplied as proof of immunity. The original should be returned to the child/student or the child's/student's parent or guardian. If a child or student is unable to submit such a statement or serologic evidence, varicella vaccine is required.

This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority.

Filed with the Office of the Secretary of State on April 26, 1999.

General Counsel

Texas Department of Health

Effective date: May 16, 1999

Proposal publication date: January 29, 1999

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

Chapter 101. Tobacco

25 TAC §101.3, §101.7

The Texas Department of Health (department) adopts an amendment to §101.3 and new §101.7, concerning general requirements for annual reports by manufacturers of tobacco products, and the security of report information, with changes to the proposed text as published in the October 30, 1998, issue of the Texas Register (23 TexReg 11042), as a result of comments received during the 30-day comment period.

The department was required to adopt rules concerning the reporting of ingredients and nicotine content of cigarette and tobacco products by Chapter 1216, 75th Legislature, 1997, Health and Safety Code, Chapter 161, Subchapter N. The amendments to §101.3 clarifies the date the first report is due to the department, which is on or before December 1, 1999. Thereafter, subsequent reports are due on or before December 1 of each year.

In earlier rule making, in response to a comment on the proposed rules, the department committed to adopt a rule establishing the security and confidentiality of information submitted to the department. Section 101.7 fulfills that commitment.

New §101.7 increases the security of information submitted to the department by specifying physical and electronic methods to prevent access by unauthorized persons. The tobacco industry believes the information submitted to the department is extremely valuable, and has suggested methods to safeguard it. Many of these suggestions have been incorporated in the final rule, and the likelihood of unauthorized access has been greatly reduced.

The following comments were received concerning the proposed sections. Following each comment is the department's response and any resulting changes.

Comment: Concerning §§101.1-101.5, one commenter stated that the department incorrectly reasoned, that the monetary expense of complying with the rules would be reduced since the provisions are similar to existing rules in Massachusetts. In addition, the commenter stated that proposed changes may occur in the Massachusetts rule that will increase the costs of complying with the Texas rule as well as provide variant data from two states that would raise constitutional issues under the commerce clause of the United States Constitution.

Response: The department appreciates the concerns of the commenter. While the department may initiate further rule-making on this topic, it is outside the scope of the issues raised by the proposed and final rules. No change was made as a result of this comment.

Comment: Concerning §101.1-101.5, one commenter stated that "reporting should not be required in the absence of an adequate economic impact analysis" for large and small manufacturers.

Response: The department appreciates the concerns of the commenter. These issues were addressed at the time Chapter 101 was proposed and adopted and are outside the scope of the issues raised by the proposed and final rules. No change was made as a result of this comment.

Comment: Concerning §101.2, one commenter stated that the revised definition of the term "ingredient" moves away from the statutory language and makes "the reporting process substantially more confusing, burdensome and complicated . . . without significant benefit to consumers."

Response: The department appreciates the concerns of the commenter. While the department may initiate further rule-making on this topic, it is outside the scope of the issues raised by the proposed and final rules here. No change was made as a result of this comment.

Comment: Concerning §101.3, two commenters stated that the reporting date should be extended in order to allow time for notice and comment on more detailed security procedures from the department.

Response: The department agrees in part and disagrees in part with the commenter. The reporting date specified in §101.3 has been changed to December 1, 1999. However the comment period for the proposed rule is fixed by law at 6 months.

Comment: Concerning §101.3, one commenter stated that "the Attorney General should be asked to opine on whether the ingredient information . . . constitutes a trade secret and will be excepted from public disclosure." Furthermore, the commenter also stated that "the Attorney General should be asked to opine on whether ingredient information . . . is excluded from public disclosure as a trade secret because it is treated as a trade secret under the federal Smokeless Tobacco Act."

Response: The department appreciates the concerns of the commenter. While the department has requested an opinion similar to this, the topic is outside the scope of the issues raised by the proposed and final rules. No change was made as a result of this comment.

Comment: Concerning §101.5, one commenter stated that requiring a report of the total nicotine content, percent filter tip ventilation, pH of cigarette smoke and amount of nicotine delivery for tobacco products exceeds "the rule-making authority expressly granted by the statute".

Response: The department appreciates the concerns of the commenter. While the department may initiate further rule-making on this topic, it is outside the scope of the issues raised by the proposed and final rules. No change was made as a result of this comment.

Comment: Concerning §101.3 and §101.7, one commenter noted that the Bureau of Chronic Disease Prevention and Control, is now the Bureau of Disease and Injury Prevention.

Response: The department agrees with the commenter. The new name of the bureau is used in §101.3 and §101.7.

Comment: Concerning §101.7, one commenter stated that the department should have an ability to compare ingredients from different years and brands for research purposes, regardless of what format is used in the submission of information.

Response: The department agrees with the commenter. A requirement that information submitted electronically must be in a searchable data base format is in §101.7(f)(3).

Comment: Concerning §101.7, two commenters stated that there is no guidance in the rule concerning the permissibility or procedure for physical or electronic copying and duplication.

Response: The department agrees with the concerns. New language was added and §101.7(d) states that most copying is prohibited, though pen and paper may be permitted.

Comment: Concerning §101.7, one commenter stated that there are no provisions present in the rule regarding the storage of information in computers or other alternate formats in order to maintain security.

Response: The department agrees with the concerns. New language was added and §101.7(f) states detailed computer security procedures.

Comment: Concerning §101.7, two commenters stated their concerns about the physical construction of the room in which the information would be stored and the security measures that would be in place to prevent unauthorized access to the information during and after business hours.

Response: The department agrees with the concerns. New language was added and §101.7(e) elaborates the physical security that will be provided, and §101.7(c) establishes detailed access procedures. This system will ensure adequate security of the information at all times from unauthorized access.

Comment: Concerning §101.7, two commenters stated that the rule does not address the circumstances under which information can be reviewed by the necessary personnel. One commenter stated that there were no restrictions in place to limit access to a room when the information is being reviewed. Another commenter suggested that access should be allowed only when more than one individual is present.

Response: The department agrees with the concerns. New language was added and §101.7(c) provides details on access, and §101.7(c)(3) provides that individuals shall not be alone when accessing the material.

Comment: Concerning §101.7, two commenters stated that the rule does not specifically state which department employees are deemed "necessary" to have access to the information.

Response: The department agrees in part and disagrees in part with the concerns. The proposed language was deleted and new language was added to §101.7. The term "necessary" is no longer stated in §101.7. Instead, §101.7(c) uses the phrase "individuals with demonstrated need" and "authorized individuals". But ultimately the access will be at the discretion of the department as needed to implement current and future legislative purposes.

Comment: Concerning §101.7, two commenters stated that a custodian should be appointed that would be responsible for controlling access to ingredient information as well as to "maintain supervisory responsibility for the storage and protection of the information."

Response: The department agrees with the commenter, and has added new language in §101.7 in response to the comment. The Bureau Chief of the Bureau of Disease and Injury Prevention, or his designee will be known as the "information control officer". The information control officer will be responsible for supervising the storage of the information and for the protection of the information from unauthorized access.

Comment: Concerning §101.7, one commenter stated that the rule does not provide specifics on who will maintain "a log for those accessing the information" or what details will be included in the log. Furthermore, one commenter stated that the proposed rule does not outline any means of tracking documents as they are handled by employees nor is there a system to ensure that the information is returned to its secure location.

Response: The department agrees with the commenter, and has added new language in §101.7 in response to the comment. The Bureau Chief of the Bureau of Disease and Injury Prevention, or his designee is named as information control officer, will be responsible for maintaining a log of each authorized employee seeking access to the information and of the date, time and documents accessed. The department feels that naming an information control officer responsible for the protection of the information and establishing a detailed access log will provide adequate tracking of documents as well as ensure the information is returned to its secure location.

Comment: Concerning §101.7, three commenters stated that the proposed rule, in addition to not providing the specific terms of the confidentiality statement, does not indicate any penalties for unauthorized breech of confidentiality by a department employee. Furthermore, the commenters stated that the department has not presented the actual confidentiality statement for comment.

Response: The department agrees in part and disagrees in part with the commenters. Section 107(c)(1) describes the confidentiality agreement, but the department feels the complete text of such a document and the range of penalties for violations is not appropriate for inclusion in the rule because of length and because personnel sanctions are more properly part of the department's personnel policies. No change was made as a result of this comment.

Comment: Concerning §101.7, one commenter believes that "encoding or encryption" of data is needed once the information is received by the department in order to adequately protect the information.

Response: The department agrees with the commenter. New language was added and §101.7(f) provides for such encryption.

Comment: Concerning §101.10, one commenter stated that the rules "fail to provide an adequate mechanism for resolving disputes about what constitutes an ingredient trade secret in order to protect valuable confidential information from disclosure under the Texas Open Records Act.

Response: The department appreciates the concerns of the commenter. While the department may initiate further rule making on this topic, it is outside the scope of the proposed rule. No change was made as a result of this comment.

Comment: Concerning §101.10, one commenter stated that "risks to public health" must be defined so as to "allow public disclosure of ingredient information . . . only where it has made a specific finding, supported by evidence, that the ingredients whose identities are to be disclosed in fact pose a risk to human health in the manner such ingredients are used in cigarettes . . ."

Response: The department appreciates the concerns with the commenter. While the department may initiate further rule making on this topic, it is outside the scope of the proposed rule. No change was made as a result of this comment.

The commenters were a group of smokeless tobacco manufacturers who submitted joint comments (Brown & Williamson Tobacco Corp., Conwood Company, L.P., National Tobacco Co., L.P., Swedish Match North America, Swisher International, Inc., and United States Tobacco Company) through their attorneys, Patton Boggs LLP; a group of manufacturers who submitted joint comments (Brown & Williamson Tobacco Corporation, Lorillard Tobacco Company, Philip Morris Incorporated, and R.J. Reynolds Tobacco Company) through their attorneys, Covington & Burling, and the department's own staff. In addition to the written comments, department staff met with representatives of the manufacturers. All commenters favored the adoption of a rule to accord security to the information submitted to the department. The commenters generally favored a higher level of security than that proposed by the department.

The amendment and new section are adopted under the Texas Health and Safety Code Chapter 161, Subchapter N which requires the Texas Board of Health to adopt rules on the disclosure of ingredients in cigarettes and tobacco products, and §12.001, which provides the Texas Board of Health with the authority to adopt rules for the performance of every duty imposed by law on the board, the department and the commissioner of health.

§101.3. General Requirements for Annual Reports by Manufacturers.

On or before December 1, 1999, the manufacturer of any cigarettes or tobacco product, excluding cigars, distributed in the State of Texas shall report to the department, in accordance with these regulations, the ingredients and nicotine yield rating of any such cigarette or tobacco product, excluding cigars. Subsequent reports shall be due on or before December 1, 2000, and every December 1 thereafter. Manufacturers of cigars shall report on the above dates in accordance with §101.4 of this title (relating to Ingredient Reporting Requirements). The report should be sent to: Bureau Chief, Bureau of Disease and Injury Prevention, Texas Department of Health, 1100 West 49th Street, Austin, Texas, 78756.

§101.7. Security of Report Information.

The department shall designate in writing an individual having the responsibility for control of ingredient information as the Information Control Officer. The Information Control Officer shall be the department's Bureau Chief, Bureau of Disease and Injury Prevention, or his/her designee. The Information Control Officer shall be responsible for maintaining and verifying the operation of an effective information control system and assuring adherence to the information protection requirements contained in this section. The department shall also designate in writing an individual to assume the responsibilities for control of ingredient information in case of the absence of unavailability of the Information Control Officer.

Each manufacturer providing ingredient information pursuant to Health and Safety Code, Chapter 161, Subchapter N, relating to Disclosure of Ingredients in Cigarettes and Tobacco Products (hereinafter "ingredient information"), shall have the option of providing such information in electronic form. Electronic form shall include, without limitation, providing access to the ingredient information on a computer system established and maintained by the manufacturer and accessible by the department as provided in these rules.

The Information Control Officer shall cause to be prepared, and shall personally approve, a list of individuals with demonstrated need to have access to the room where the ingredient information contained in reports submitted pursuant to Health and Safety Code, Chapter 161, Subchapter N, who have satisfied the requirements of this subsection (hereinafter "authorized individuals"). The Information Control Officer is responsible for keeping the list current, adding individuals, and immediately deleting any individual who no longer has a need to have access to the information, or who no longer satisfies the criteria for access.

No individual is authorized to have access to reported ingredient information unless that individual has executed and provided to the Information Control Officer a Confidentiality Agreement emphasizing the law and the individual's obligations to keep sensitive information confidential.

Individuals authorized to have access to reported ingredient information who are not full-time employees or contractors of the department must have satisfactorily undergone a thorough background check (including credit, criminal record, and civil litigation) by a qualified organization selected by the Information Control Officer, the results of which have been provided to and approved by the Information Control Officer.

No authorized individual shall have access to reported ingredient information at any time or in any manner unless another authorized individual is present during the entire period of access.

The Information Control Officer shall personally approve, in advance, all entries into any area in which report ingredient information is accessible or potentially accessible for purposes of cleaning, maintenance, computer maintenance, refurbishing, repair of such area, or similar activities, and shall maintain a list of all such entries, including time of entry and exit and identification of any individual present in such area who is not an authorized individual including the signature of each such person. An authorized individual shall be present during the entire period of any such entry, and shall be responsible for ensuring that no reported ingredient information is visible, and that any such unauthorized individual is properly identified and legitimately performing such activities.

No copies of any brand-specific reported ingredient information shall be made by any means, including, without limitation, by photocopier, by camera, or electronically, typing on a typewriter, word processor or computer, scanning, or using a dictaphone or a telephone except by pen and paper, nor shall any reported ingredient information be otherwise or further transmitted or communicated by any means. With the exception of a computer terminal for the receipt or review of reported ingredient information supplied electronically, no such device, other than pen and paper, shall be permitted in any area in which reported ingredient information is accessible or potentially accessible, nor shall packages and briefcases be brought into any such area, and the Information Control Officer shall take all steps necessary to ensure that these requirements have been met and that no reported brand-specific ingredient information has been removed from such area, or transmitted or communicated. Authorized individuals shall take all precautions necessary to ensure that no unauthorized person overhears or otherwise intentionally or inadvertently receives such information.

Information identified by the manufacturer as confidential ingredient information in a report pursuant to Health and Safety Code, Chapter 161, Subchapter N, that is submitted in hard paper copy or in electronic form shall be secured and maintained in a secure storage room.

Computer workstation(s) to be used to access information in reports submitted electronically in accordance with the procedures provided in these rules shall also be kept in a secure storage room.

The storage room shall be located in an interior space that does not share a perimeter wall with an adjacent space occupied by a person or organization other than the department.

The storage room walls shall be of substantial construction, and the walls shall not contain any windows or any mechanical openings larger than 90 square inches.

There shall be only one door in the storage room, with a double cylinder deadbolt lock. The door shall be kept locked at all times when the room is not in use.

There shall be no more than two keys to the door lock, which shall be kept in a locked key container under the direct control of the Information Control Officer and shall not be removed from the premises.

The Information Control Officer shall insure that all keys issued shall be logged out and logged in and the log shall indicate the date, time and the person whom the key was issued and the date and time the key was returned.

The keys shall be issued to only those persons who are authorized to be in the storage room, as determined by the Information Control Officer in accordance with subsection (c) of this section.

Computer Security.

The computer used for purposes of accessing ingredient information reported electronically pursuant to Health and Safety Code, Chapter 161, Subchapter N, not be used for any other purpose. The computer screen shall be aligned in such a manner that it is not viewable from the outside of the secure storage room when the door is open. The computer shall be turned off when not in use.

The computer shall have a CD-ROM drive, and shall be connected to the internet and to a dedicated telephone line, which connections the department shall be responsible for maintaining. The computer shall not have a printer or other peripherals (other than a fingerprint reader), including removable magnetic or optical storage devices attached to it.

An entity that reports ingredient information electronically under Chapter 161, Subchapter N of the Health and Safety Code shall provide the department with a CD-ROM containing electronic encryption software to enable an authorized user at the department to obtain access to the reported information on the department's computer. This information must be in the form of a searchable data base, with fields for brand name, ingredient, and year. The Information Control Officer shall be responsible for maintaining the CD-ROM in a locked container under the direct control of the Information Control Officer, and shall ensure that it shall not be provided to any person who is not an authorized individual pursuant to subsection (c) of this section.

Access to ingredient information shall be initiated by an authorized individual at the department during business hours by inserting the CD-ROM provided by the reporting entity into the department's designated computer and establishing a connection to a computer system linked to the reporting entity. The reporting entity shall be responsible for:

determining a means of connection to the department, whether by private network, Internet connection or otherwise; and

providing on the CD-ROM given to the department the protocol for making the connection.

After the connection has been made, the identity of the authorized users at the department who will be present when the information is displayed shall be authenticated by means of a fingerprint reader attached to the computer. The Information Control Officer shall ensure that each authorized individual completes the necessary procedures to obtain access.

After the identity of the users at the department has been properly authenticated, access to the data files of the reporting entity containing the ingredient information reported pursuant to Health and Safety Code, Chapter 161, Subchapter N, will be provided.

A session of reviewing data files shall terminate when either an authorized individual logs off in accordance with the protocol on the CD-ROM, or following a predetermined time period with no user activity.

This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority.

Filed with the Office of the Secretary of State on April 26, 1999.

General Counsel

Texas Department of Health

Effective date: May 16, 1999

Proposal publication date: October 30, 1999

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

Part II. Texas Department of Mental Health and Mental Retardation

Chapter 406. ICF/MR Programs

Subchapter B. Contracting Requirements

25 TAC §406.53

The Texas Department of Mental Health and Mental Retardation (department) adopts amendments to §406.53, concerning provider application requirements specific to ICF/MR, of Chapter 406, Subchapter B, concerning contracting requirements, without changes to the text as proposed in the February 12, 1999, issue of the Texas Register (24 TexReg 904).

The amendments allow the department to manage the capacity of individual state schools and state centers by transferring beds between facilities while ensuring that the capacity of all state schools and state centers does not exceed the number authorized in The Long Term Care Plan for People with Mental Retardation and Related Conditions required by Texas Health and Safety Code, §533.062. Additionally, the amendments permit a residential facility seeking initial certification in the ICF/MR program to have a capacity of more than six beds if that facility has been funded solely with state funds previously, and is approved by the department to apply to participate in the ICF/MR program as part of the refinancing initiative authorized by the General Appropriations Act, 75th Legislature, Article II, Page 68, Paragraph 9 (1997).

The amendments also delete an extraneous "shall" in subsection (a); replace commas with semicolons in subsection (a)(1)(A) and (B); delete an extraneous "the" before "TDMHMR" in subsection (b); substitute "person" for "individual" in subsection (b)(1)(B) to be consistent with terminology used elsewhere in the section; and replace "catchment area" with "local service area" consistent with current department usage. In addition, a reference in subsection (e) to the statutorily required long term care plan is updated with the plan's present title, which is "The Long Term Care Plan for People with Mental Retardation and Related Conditions." In that same subsection, the term "current" is added before the title of the plan to clarify that new ICF/MR applications may not exceed the total ICF/MR program capacity established by the plan in effective at the time of the application. Also in subsection (e), the statutory reference requiring the development of the plan has been added for the convenience of persons complying with the rule and the term "service capacity" is replaced with "authorized bed capacity" to be consistent with terminology used in the plan.

A hearing to accept oral and written testimony from members of the public was held on February 19, 1999, in Austin. No testimony was offered. Written comments were received from the parent/guardian of a state school resident, Garland; Parent Association for the Retarded of Texas; and Beaumont State Center.

A commenter questioned the department's justification for permitting a residential facility previously funded with state funds that is seeking initial certification in the ICF/MR program to have a certified capacity of more than six beds. The department responds the facilities that will be certified in the ICF/MR program with more than six beds under this provision are, at the time they seek certification, providing residential services to more than six individuals. The department will not require a facility to force some of their residents to move. These facilities are seeking initial certification in the ICF/MR program in compliance with the legislature's refinancing initiative authorized by the General Appropriations Act, 75th Legislature, Article II, Page 68, Paragraph 9 (1997).

Two commenters questioned why the preamble to the proposed amendment states that the department will transfer beds from one state school or center to another while the text of the amendment does not address transfers. The commenters suggested that the department could use this provision to justify reducing the census at one or more state schools, eventually resulting in closure of those facilities. The department responds that the explanation of the transfer of beds in the preamble was used to describe the mechanism by which certified bed capacities are adjusted. The department does not believe it necessary to include the transfer language in the text of the rule. Further the department responds that the provision may be used to reduce the certified capacity at one state school or center so that the certified capacity at another state school or center may be increased to address changing needs for campus-based residential services across the state. The provision is intended as an exception to the stated six-bed capacity limit to permit a state school or center to increase its capacity.

The amendments are adopted under the Texas Health and Safety Code, §532.015(a), which provides the Texas Board of Mental Health and Mental Retardation with broad rulemaking authority; the Texas Government Code, §531.021(a), and the Texas Human Resources Code, §32.021(a), which provide the Texas Health and Human Services Commission (THHSC) with the authority to administer the federal medical assistance (Medicaid) program in Texas; Acts 1995, 74th Texas Legislature, Chapter 6, §1, (Senate Bill 509), which clarifies the authority of THHSC to delegate the operation of all or part of a Medicaid program to a health and human services agency; and the Human Resources Code, §32.021(c), which provides an agency operating part of the Medicaid program with the authority to adopt necessary rules for the proper and efficient operation of the program. THHSC has delegated to the department the authority to operate the ICF/MR program.

This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority.

Filed with the Office of the Secretary of State on April 26, 1999.

Chair, Texas MHMR Board

Texas Department of Mental Health and Mental Retardation

Effective date: May 16, 1999

Proposal publication date: February 12, 1999

For further information, please call: (512) 206-4516

Subchapter C. Vendor Payments

25 TAC §406.101

The Texas Department of Mental Health and Mental Retardation (TDMHMR) adopts amendments to §406.101 concerning vendor payments, of Chapter 406, Subchapter C, concerning vendor payments, without changes to the text as proposed in the February 12, 1999, issue of the Texas Register (24 TexReg 906).

The amendments stipulate that when an individual's Medicaid eligibility is established after the provision of services in the Intermediate Care Facilities for Persons with Mental Retardation (ICF/MR) Program in Texas, a claim for those services must be received by National Heritage Insurance Company (NHIC) no later than 180 calendar days from the date Medicaid eligibility is established. The current rule allows these claims to be received 30 days after the provider is notified of Medicaid eligibility or 180 calendar days after the end of the service month, whichever is later. The amendment will make the ICF/MR claims submission requirements consistent with those of other Texas human services programs.

No comments were received concerning the proposal.

The amendments are adopted under the Texas Health and Safety Code, §532.015(a), which provides the Texas Board of Mental Health and Mental Retardation with broad rulemaking authority; the Texas Government Code, §531.021(a), and the Texas Human Resources Code, §32.021(a), which provide the Texas Health and Human Services Commission (THHSC) with the authority to administer the federal medical assistance (Medicaid) program in Texas; Acts 1995, 74th Texas Legislature, Chapter 6, §1, (Senate Bill 509), which clarifies the authority of THHSC to delegate the operation of all or part of a Medicaid program to a health and human services agency; and the Human Resources Code, §32.021(c), which provides an agency operating part of the Medicaid program with the authority to adopt necessary rules for the proper and efficient operation of the program. THHSC has delegated to the department the authority to operate the ICF/MR program.

This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority.

Filed with the Office of the Secretary of State on April 26, 1999.

Chair, Texas MHMR Board

Texas Department of Mental Health and Mental Retardation

Effective date: May 16, 1999

Proposal publication date: February 12, 1999

For further information, please call: (512) 206-4516

Chapter 409. Medicaid Programs

Subchapter D. Home and Community-based Services (HCS)

25 TAC §409.103, §409.109

The Texas Department of Mental Health and Mental Retardation (department) adopts amendments to §409.103, concerning payment category assignment and provider claims payment, and §409.109, concerning corrective action and provider sanctions, of Chapter 409, Subchapter D, concerning home and community-based services (HCS), with changes to the text as proposed in the February 12, 1999, issue of the Texas Register (24 TexReg 906).

The amendments to §409.103 clarify the criteria for increasing the level-of-need of a consumer who exhibits dangerous behavior and for assigning the "pervasive plus" level-of-need (LON 9) to a consumer who exhibits extremely dangerous behavior. The amendments also replace all references to the Level-of-Care Assessment Form (TDHS Form 3650) with references to the department's new MR/RC Assessment Form, which has replaced Form 3650 for purposes of reporting a consumer's level-of-care and level-of-need. In addition, a reference in §409.103(c)(1) is corrected. The amendments clarify the criteria for increasing a consumer's LON when the consumer exhibits dangerous behavior and for assigning a "pervasive plus" LON to a consumer. In addition, use of the new assessment form in the HCS program will ensure consistency with its use in the Intermediate Care Facilities for Persons with Mental Retardation (ICF/MR) program.

The amendments to §409.109 modify Principles 18 and 62 of the HCS Consumer Principles for Evidentiary Certification (Figure 1: 25 TAC § 409.109). Principle 18 is amended to clarify that no more than three consumers receiving HCS program or similar services for which the provider is reimbursed may live in a foster/companion care residence at any one time, and that no more than three consumers, whether or not receiving HCS program services, may live in a residential support residence at any one time regardless of their relationship to each other or to the care provider. Principle 62 is amended to allow for the provision of out-of-home respite services for up to six consumers at a time in a respite facility that is not the residence of any person. The amendment allows providers the option of offering out-of-home respite services in a respite facility that is not the residence of any consumer receiving HCS program services.

The proposed amendments §409.103(c)(1)(B)(iii) are revised upon adoption to clarify the criteria for increasing a LON assignment by specifying that the provider must have more staff available than would be necessary if the consumer did not exhibit the dangerous behavior and that staff must be constantly prepared to physically prevent the dangerous behavior or intervene when the behavior occurs. In §409.109, the proposed language of Principle 62 is revised upon adoption to ensure that consumers' needs and welfare are addressed in the selection of respite sites. Principle 62.01 is revised to specify that when HCS respite services are provided in a residence, including that of a consumer receiving HCS program services, no more than three persons receiving HCS program services or similar services for which the provider is reimbursed may receive services in the residence at any one time. As proposed, the principle could have been interpreted to allow HCS services to be provided to five consumers in the residence of a sixth consumer or to allow an unlimited number of consumers to receive services in the residence of someone other than a consumer.

A hearing to accept oral and written testimony from members of the public was held on March 9, 1999, in Austin. No testimony was offered. Written comments were received from: two private providers of HCS services, Golden Rule Services of Friendswood and New Avenues of Hope of El Paso; Private Providers Association of Texas, Austin; Advocacy, Inc., Austin; and Amarillo State Center.

A commenter suggested that the proposed amendments to §409.103 be withdrawn because of ongoing problems with the department's utilization review process including the interpretation of utilization review rules by Medicaid staff. The department declines to withdraw the proposed revisions because they respond to providers' requests for clarification of the criteria for assigning increases in LON and are consistent with the recommendations of the Utilization Review Advisory Committee. Also, the revised rule will bring the HCS program criteria more closely into alignment with ICF/MR program criteria for increasing the LON and assigning the pervasive plus LON recently approved by the Texas Mental Health and Mental Retardation Board.

The same commenter recommended that the Utilization Review Advisory Committee be reconvened to consider rule revisions concerning increases in the LON and assignment of the pervasive plus LON, as well as potential revisions to the interpretive guidelines and other products developed by the committee during the spring of 1998. The commenter further stated that providers must be reimbursed adequately in order to provide appropriate supervision for consumers and meet all other HCS program requirements. The Medicaid Steering Committee may request that a workgroup be organized to address utilization review issues. The department agrees that providers must receive adequate reimbursement and believes the revised rule will ensure this happens for those consumers who require additional supervision.

A commenter stated that the utilization review process is burdensome, confusing, overly prescriptive, and time-consuming and requested that the department offer additional training to providers. The department responds that a session on LON assignment, utilization review, and related topics has been scheduled during the ICF/MR and HCS providers conference to be held August 3-6, 1999, in Austin, and that it will work with the provider community to develop other opportunities for additional training.

Two commenters requested that the term "additional staff" in § 409.103(c)(1)(B)(iii) be defined in the rule. One of the two commenters stated that an increase to the next LON barely pays for a quarter-time equivalent and suggested that "additional staff" be defined as "staffing patterns that exceed the minimum staffing patterns identified in federal regulations." The department responds that federal regulations concerning community-based waiver programs do not set minimum staffing requirements. The department has clarified the criteria for increasing a LON assignment by specifying that the provider must have more staff available than would be necessary if the consumer did not exhibit the dangerous behavior and that staff must be constantly prepared to physically prevent the dangerous behavior or intervene when the behavior occurs.

One commenter requested that the term "very challenging behavior" used in the current rule be retained, noting that some consumers exhibit behaviors that require additional staff to prevent or control yet the behaviors do not meet the criteria of "dangerous behavior" in the proposed amendments or in the existing guidelines. The department declines to make the suggested changes and responds that the amendments do not change the range of behaviors covered under the current rule. Both the current rule and the amendments address behaviors that are dangerous to the consumer or to others. The proposed revisions clarify that behavior is dangerous if it could result in serious physical injury, consistent with the recommendations of the Utilization Review Advisory Committee.

Two commenters requested that the description of "extremely dangerous behavior" in §409.103(c)(1)(C) be broadened and clarified. The commenters stated that behaviors other than those that might be life threatening also require constant one-to-one supervision if the consumer is to live in the community. One commenter cited consumers with a background of criminal conduct as an example, and stated that the behavior of these consumers may not be life threatening but does require constant supervision. The department will not expand the criteria for assignment of the pervasive plus LON to include other behaviors which are not life threatening. The pervasive plus LON and its reimbursement were specifically designed to address the increased levels of service and support which must be provided for that small number of consumers who display behavior that is life-threatening to that consumer or to others.

One commenter expressed support for Principle 18, which specifies that the residence of a consumer receiving foster/companion care or residential support must be designed for family-style living. The department acknowledges the support.

Another commenter questioned whether Principle 18 would restrict family members from providing foster/companion care services in the consumer's home. The department responds that it does not. The principle was amended to clarify that no more than three consumers receiving HCS program services or similar services for which the provider is reimbursed may be served in a foster/companion care home regardless of their relationship to one another or to the care provider. Under the waiver program, a family member who lives with an adult consumer may be paid to provide foster/companion care in the home when such an arrangement is considered to be in the consumer's best interests.

One commenter asked if two sites located on the grounds of a state facility would qualify as "non-institutional" sites in which respite services could be provided to up to six people. The department responds that a respite facility located at a state facility that is not ICF/MR certified would qualify as an acceptable respite facility under the revised principle. The state facility could use both of its sites to provide HCS respite services as long as no more than six consumers are receiving respite services at the state facility at any one time.

Two commenters stated that the revisions to Principle 62.01 are confusing and imply that respite services can be provided to five consumers in the residence of a sixth consumer. One commenter objected strongly to more than three consumers living in a single residence. The department agrees that the language as proposed is confusing and has revised it to specify that when HCS respite services are provided in a residence, including that of a consumer receiving HCS program services, no more than three persons receiving HCS program services or similar services for which the provider is reimbursed may receive services in the residence at any one time.

Two commenters commended the requirement in Principle 62.02 that the consumer or the consumer's LAR must agree to the provision of respite services in the consumer's residence. They asked that the principle also require that the preferences of the resident consumer for activities that will occur during the respite period be given priority over the preferences of the respite consumer. The department responds that the recommendation is worthy of consideration, but declines to make the revision at this time without the opportunity for all stakeholders to review and comment on the suggestion.

Two commenters recommended that a limit be placed on the number of days respite may be provided in a consumer's residence. The commenters stated that a limit is necessary to ensure that the resident consumer is not constantly disrupted by the temporary presence of other consumers, and offered to work with providers, consumers and LARs, other advocates, and the department to determine an appropriate limit. The department responds that the recommendation is worthy of consideration, but declines to make the revision at this time without the opportunity for all stakeholders to review and comment on the suggested limit.

The amendments are adopted under the Texas Health and Safety Code, § 532.015(a), which provides the Texas Board of Mental Health and Mental Retardation with broad rulemaking authority; the Texas Government Code, § 531.021(a), and the Texas Human Resources Code, §32.021(a), which provide the Texas Health and Human Services Commission (THHSC) with the authority to administer the federal medical assistance (Medicaid) program in Texas; Acts 1995, 74th Texas Legislature, Chapter 6, §1, (Senate Bill 509), which clarifies the authority of THHSC to delegate the operation of all or part of a Medicaid program to a health and human services agency; and the Human Resources Code, §32.021(c), which provides an agency operating part of the Medicaid program with the authority to adopt necessary rules for the proper and efficient operation of the program. THHSC has delegated to the department the authority to operate the HCS program.

§409.103.Payment Category Assignment and Provider Claims Payment.

Reimbursement for HCS foster care, residential supports, and day habilitation is based upon the program participant's payment category assignment and the reimbursement rate for the specific service component provided.

The payment category for a program participant is based upon a level-of-need (LON) assignment completed by TDMHMR or its designee as part of the level-of-care determination according to §406.203 of this title (relating to Eligibility for Level-of-care Determination). LON assignments are derived from the service level score obtained from the administration of the Inventory for Client and Agency Planning (ICAP) to the program applicant/participant and from selected items on the MR/RC Assessment Form.

An HCS Program applicant or participant is assigned one of the following five levels of need:

An intermittent LON (LON 1) is assigned if the individual's ICAP service level score equals 7, 8, or 9;

A limited LON (LON 5) is assigned if the individual's ICAP service level score equals 4, 5, or 6;

An extensive LON (LON 8) is assigned if the individual's ICAP service level score equals 2 or 3;

A pervasive LON (LON 6) is assigned if the individual's ICAP service level score equals 1;

Regardless of an individual's ICAP service level score, a pervasive plus LON (LON 9) is assigned if the individual meets the criteria set forth in subparagraph (C) of this paragraph.

LON assignments 1, 5, and 8, made in accordance with subparagraph (A) of this paragraph may be increased to the next LON if:

the individual exhibits dangerous behavior that could cause serious physical injury to the individual or others;

a written behavior intervention plan has been implemented that is based on ongoing written data, targets the dangerous behavior with individualized objectives, and specifies intervention procedures to be followed when the dangerous behavior occurs;

more staff are needed and available than would be needed if the individual did not exhibit dangerous behavior;

staff are constantly prepared to physically prevent the dangerous behavior or intervene when the behavior occurs; and

the MR/RC Assessment Form is correctly scored with a "1" in the "Behavior" section.

An individual who exhibits extremely dangerous behavior and whose MR/RC Assessment Form is correctly scored with a "2" in the "Behavior" section is assigned a pervasive plus LON (LON 9). Extremely dangerous behavior:

could be life threatening to the individual or to others;

must be targeted with individualized objectives in a written behavior intervention plan that is based on ongoing written data and specifies intervention procedures to be followed when the behavior occurs; and

is managed by provider staff whose duty is to exclusively and constantly supervise the individual during the individual's waking hours, which must be at least 16 hours per day.

The provider completes the ICAP, enters the resulting service level score on the MR/RC Assessment Form, and completes the remainder of the form Information entered on the MR/RC Assessment Form must represent the applicant's/participant's current status. A completed MR/RC Assessment Form is submitted to TDMHMR for initial program enrollment or for annual eligibility reevaluation.

TDMHMR reviews LON assignments and, if made in accordance with criteria in this subsection, approves the LON assignment.

If TDMHMR determines that information submitted for a LON was not correct or if information previously submitted has changed, the LON assignment is reevaluated and may be changed by TDMHMR. If the LON assignment is changed, reimbursement paid to providers will be adjusted back to the date of the original LON assignment in order to reflect the appropriate LON assignment.

The provider in disagreement with an individual's changed LON assignment may request reconsideration by TDMHMR or its designee. Providers must submit a written request for reconsideration of a changed LON assignment in accordance with §409.120 of this title (relating to Utilization Review) to TDMHMR or its designee within 10 calendar days of notification of a changed LON assignment.

TDMHMR may perform annual reevaluations of LON assignments in conjunction with annual reevaluations of ICF-MR LOC.

If a higher LON assignment is requested at the time of the annual eligibility reevaluation, the provider must submit supporting documentation to TDMHMR describing the changes in the individual's needs in accordance with §409.120 of this title (relating to Utilization Review).

A provider in disagreement with TDMHMR's denial to increase an individual's LON assignment may request reconsideration by TDMHMR. The provider must submit a written request for reconsideration of the denial in accordance with §409.120 of this title (relating to Utilization Review) to TDMHMR or its designee within 10 calendar days of notification of the denial.

Providers requesting a change to a higher LON at times other than the annual reevaluation must submit an MR/RC Assessment Form with supporting documentation describing the changes in the individual's needs to TDMHMR in accordance with §409.120 (relating to Utilization Review). A provider in disagreement with TDMHMR's denial to increase an individual's LON assignment may request reconsideration by TDMHMR or its designee. The provider must submit a written request for reconsideration of the denial in accordance with §409.120 of this title (relating to Utilization Review) to TDMHMR within 10 calendar days of notification of the denial.

§409.109.Corrective Action and Provider Sanction.

The HCS provider must be in continuous compliance with the HCS Consumer Principles for Evidentiary Certification. Each HCS provider will receive a certification review at least annually in order to maintain certification status. The guidelines specified in §§409.110-409.115 of this title (relating to Hazards to Health, Safety, and Welfare; Level I Action; Level II Action; Level III Action; Unannounced or Intermittent Review Visits; and Discretionary Certification Sanctions) are used by TDMHMR to determine the need for provider sanctions and/or provider onsite follow up review visits that occur before those required concurrently with the recertification review. Current certification review corrective action plans required from the provider and related timelines remain in effect.

Figure: 25 TAC §409.109

This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority.

Filed with the Office of the Secretary of State on April 26, 1999.

Chair, Texas MHMR Board

Texas Department of Mental Health and Mental Retardation

Effective date: May 16, 1999

Proposal publication date: February 12, 1999

For further information, please call: (512) 206-4516

Subchapter E. Home and Community-based Waiver Services - OBRA (HCS-O)

25 TAC §409.167

The Texas Department of Mental Health and Mental Retardation (department) adopts amendments to §409.167, concerning corrective action and provider sanction, of Chapter 409, Subchapter E, concerning home and community-based waiver services - OBRA (HCS-O) with changes to the text as proposed in the February 12, 1999, issue of the Texas Register (24 TexReg 909).

The amendments modify Principles 22 and 102 of the HCS-O Consumer Principles for Evidentiary Certification (Figure 1: 25 TAC §409.167). Principle 22 is amended to clarify that no more than three consumers receiving HCS-O program or similar services for which the provider is reimbursed may live in a foster/companion care residence at any one time, and that no more than three consumers, whether or not receiving HCS-O program services, may live in a residential support residence at any one time regardless of their relationship to each other or to the care provider. Principle 102 is amended to allow for the provision of out-of-home respite services for up to six consumers at a time in a respite facility that is not the residence of any person.

The proposed amendments to Principle 102 are revised upon adoption to ensure that consumers' needs and welfare are addressed in the selection of respite sites. Principle 102.01 is revised to specify that when HCS-O respite services are provided in a residence, including that of a consumer receiving HCS-O program services, no more than three consumers receiving HCS-O program services or similar services for which the provider is reimbursed may receive services in the residence at any one time. As proposed, the principle could have been interpreted to allow HCS-O services to be provided to five consumers in the residence of a sixth consumer or to allow an unlimited number of consumers to receive services in the residence of someone other than a consumer.

A hearing to accept oral and written testimony from members of the public was held on March 9, 1999, in Austin. No testimony was offered. Written comments were received from New Avenues of Hope of El Paso, private provider of HCS-O services; Private Providers Association of Texas, Austin; Advocacy, Inc., Austin; Beaumont State Center; and Amarillo State Center.

One commenter expressed support for Principle 22, which specifies that the residence of a consumer receiving foster/companion care or residential support must be designed for family-style living. The department acknowledges the support.

A commenter suggested that the addition of examples in HCS-O Principle 102.03 would be helpful. The department responds that the principles adequately describe the characteristics of a facility appropriate for providing respite to six consumers and therefore declines to provides examples of specific types of facilities. The department encourages providers to consult the department about specific sites they are considering.

One commenter asked if two sites located on the grounds of a state facility would qualify as "non-institutional" sites in which respite services could be provided to up to six people. The department responds that a respite facility located at a state facility that is not ICF/MR certified would qualify as an acceptable respite facility under the revised principle. The state facility could use both of its sites to provide HCS-O respite services as long as no more than six consumers are receiving respite services at the state facility at any one time.

Two commenters stated that the revisions to Principle 22 are confusing and imply that respite services can be provided to five consumers in the residence of a sixth consumer. One commenter objected strongly to more than three consumers living in a single residence. The department agrees that the language as proposed is confusing and has revised it to specify that when HCS-O respite services are provided in the residence of a consumer receiving HCS-O program services, no more than three consumers receiving HCS-O program services or similar services for which the provider is reimbursed may receive services in the residence at any one time.

Two commenters commended the requirement in Principle 102.02 that the consumer or the consumer's LAR must agree to the provision of respite services in the consumer's residence. They asked that the principle also require that the preferences of the resident consumer for activities that will occur during the respite period be given priority over the preferences of the respite consumer. The department responds that the recommendation is worthy of consideration, but declines to make the revision at this time without the opportunity for all stakeholders to review and comment on the suggestion.

Two commenters recommended that a limit be placed on the number of days respite may be provided in a consumer's residence. The commenters stated that a limit is necessary to ensure that the resident consumer is not constantly disrupted by the temporary presence of other HCS-O consumers, and offered to work with providers, consumers and LARs, other advocates, and the department to determine an appropriate limit. The department responds that the recommendation is worthy of consideration, but declines to make the revision at this time without the opportunity for all stakeholders to review and comment on the suggested limit.

The amendments are adopted under the Texas Health and Safety Code, §532.015(a), which provides the Texas Board of Mental Health and Mental Retardation with broad rulemaking authority; the Texas Government Code, §531.021(a), and the Texas Human Resources Code, §32.021(a), which provide the Texas Health and Human Services Commission (THHSC) with the authority to administer the federal medical assistance (Medicaid) program in Texas; Acts 1995, 74th Texas Legislature, Chapter 6, §1, (Senate Bill 509), which clarifies the authority of THHSC to delegate the operation of all or part of a Medicaid program to a health and human services agency; and the Human Resources Code, §32.021(c), which provides an agency operating part of the Medicaid program with the authority to adopt necessary rules for the proper and efficient operation of the program. THHSC has delegated to the department the authority to operate the HCS-O program.

§409.167.Corrective Action and Provider Sanction.

The HCS-O provider must be in continuous compliance with the HCS-O Consumer Principles for Evidentiary Certification as described in this section. Each HCS-O provider will receive a certification review at least annually in order to maintain certification status. The guidelines specified in §§409.168-409.173 of this title (relating to Hazards to Health, Safety and Welfare; Level I Action; Level II Action; Level III Action; Unannounced or Intermittent Review Visits; and Discretionary Certification Sanctions) are used by TDMHMR to determine the need for provider sanctions and/or provider on-site follow-up review visits that occur before those required concurrently with the recertification review. Current certification review corrective action plans required from the provider and related timelines that are referenced in the HCS-O Program Provider Manual remain in effect, if applicable.

Figure: 25 TAC §409.167

This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority.

Filed with the Office of the Secretary of State on April 26, 1999.

Chair, Texas MHMR Board

Texas Department of Mental Health and Mental Retardation

Effective date: May 16, 1999

Proposal publication date: February 12, 1999

For further information, please call: (512) 206-4516

Subchapter L. Mental Retardation Local Authority (MRLA) Program

25 TAC §409.531

The Texas Department of Mental Health and Mental Retardation (department) adopts amendments to §409.531, concerning certification status, of Chapter 409, Subchapter L, concerning mental retardation local authority (MRLA) program, with changes to the text as proposed in the February 12, 1999, issue of the Texas Register (24 TexReg 909).

The amendments modify Principle P14 and Principle P16 of MRLA Program Principles for Program Providers (Figure 1: 25 TAC §409.531). Principle P14 is amended to require that no more than three consumers receiving MRLA program or similar services for which the provider is reimbursed may live in a foster/companion care residence at any one time, and that no more than three consumers, whether or not receiving MRLA program services, may live in a residential support residence at any one time. Principle P16 is amended for the provision of out-of-home respite services for up to six consumers at a time in a respite facility which is not the residence of any person.

The proposed amendments to Principle 16.1 are revised upon adoption to ensure that consumers' needs and welfare are addressed in the selection of respite sites. Principle 16.1 is revised upon adoption to replace "are" with "shall" for consistency with other principles. Principle 16.2 is revised to specify that when MRLA respite services are provided in a residence, including that of a consumer receiving MRLA program services, no more than three consumers receiving MRLA program services or similar services for which the provider is reimbursed may receive services in the residence at any one time. As proposed, the principle could have be interpreted to allow MRLA services to be provided to five consumers in the residence of a sixth consumer or to allow an unlimited number of consumers to receive services in the residence of someone other than a consumer.

A hearing to accept oral and written testimony from members of the public was held on March 9, 1999, in Austin. No testimony was offered. Written comments were received from the Private Providers Association of Texas, Austin; Advocacy, Inc., Austin; and Beaumont State Center;.

One commenter expressed support for Principle 14, which specifies that the residence of an consumer receiving foster/companion care or residential support must be designed for family-style living. The department acknowledges the support.

Another commenter questioned whether Principle 14 would restrict family members from providing foster/companion care services in the consumer's home. The department responds that it does not. The principle was amended to clarify that no more than three consumers can be served in a foster/companion care home regardless of their relationship to one another or to the care provider. Under the waiver program, a family member who lives with an adult consumer may be paid to provide foster/companion care in the home when such an arrangement is considered to be in the consumer's best interests.

Two commenters stated that the revisions to Principle 16.2 are confusing and imply that respite services can be provided to five consumers in the residence of a sixth consumer. One commenter objected strongly to more than three consumers living in a single residence. The department agrees that the language as proposed is confusing and has revised it to specify that when MRLA respite services are provided in the residence of a consumer receiving MRLA program services, no more than three consumers receiving MRLA program services or similar services for which the provider is reimbursed may receive services in the residence at any one time.

Two commenters commended the requirement in Principle 16.3 that the consumer or the consumer's LAR must agree to the provision of respite services in the consumer's residence. They asked that the principle also require that the preferences of the resident consumer for activities that will occur during the respite period be given priority over the preferences of the respite consumer. The department responds that the recommendation is worthy of consideration, but declines to make the revision at this time without the opportunity for all stakeholders to review and comment on the suggestion.

Two commenters recommended that a limit be placed on the number of days respite may be provided in a consumer's residence. The commenters stated that a limit is necessary to ensure that the resident consumer is not constantly disrupted by the temporary presence of other MRLA consumers, and offered to work with providers, consumers and LARs, other advocates, and the department to determine an appropriate limit. The department responds that the recommendation is worthy of consideration, but declines to make the revision at this time without the opportunity for all stakeholders to review and comment on the suggested limit.

A commenter suggested that the addition of examples in MRLA Principle 16.4 would be helpful. The department responds that the principles adequately describe the characteristics of a facility appropriate for providing respite to six consumers and therefore declines to provides examples of specific types of facilities. The department encourages providers to consult the department about specific sites they are considering.

The amendments are adopted under the Texas Health and Safety Code, §532.015(a), which provides the Texas Board of Mental Health and Mental Retardation with broad rulemaking authority; the Texas Government Code, §531.021(a), and the Texas Human Resources Code, §32.021(a), which provide the Texas Health and Human Services Commission (THHSC) with the authority to administer the federal medical assistance (Medicaid) program in Texas; Acts 1995, 74th Texas Legislature, Chapter 6, §1, (Senate Bill 509), which clarifies the authority of THHSC to delegate the operation of all or part of a Medicaid program to a health and human services agency; and the Human Resources Code, §32.021(c), which provides an agency operating part of the Medicaid program with the authority to adopt necessary rules for the proper and efficient operation of the program. THHSC has delegated to the department the authority to operate the MRLA program.

§409.531.Certification Status.

MRLA program providers contracting with TDMHMR for participation in the MRLA Program must be in continuous compliance with the MRLA Program Principles for Program Providers as described in Mental Retardation Local Authority Program Principles for Program Providers. Each MRLA program provider participating in the MRLA Program will receive a certification review conducted by TDMHMR or its designee at least annually in order to maintain certification status.

Figure: 25 TAC §409.531(a)

TDMHMR personnel will conduct all certification reviews of MRLA program providers operated by the local MRA.

TDMHMR or its designee will conduct all certification reviews of non-MRA operated program providers.

Certification review corrective actions required from the program provider as determined by prior reviews under the HCS or MRLA Consumer Principles for Certification and related timelines remain in effect until the first certification review as an MRLA program provider.

This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority.

Filed with the Office of the Secretary of State on April 26, 1999.

Chair, Texas MHMR Board

Texas Department of Mental Health and Mental Retardation

Effective date: May 16, 1999

Proposal publication date: February 12, 1999

For further information, please call: (512) 206-4516

Chapter 419. Medicaid State Operating Agency Responsibilities

Subchapter O. Enrollment of Medicaid Waiver Program Providers

25 TAC §§419.701-419.710

The Texas Department of Mental Health and Mental Retardation (TDMHMR) adopts new §§419.701 - 419.710 of Chapter 419, Subchapter O, concerning Enrollment of Medicaid Waiver Program Providers, which was proposed in the February 12, 1999, issue of the Texas Register (24 TexReg 910). Sections 419.701 - 419.707 and 419.709 are adopted without changes. Sections 419.708 and 419.710 are adopted with changes.

The new sections establish the process and conditions under which TDMHMR enrolls providers of home and community-based services waiver programs including Home and Community-based Services (HCS), Home and Community-based Services - OBRA (HCS-O), and Mental Retardation Local Authority (MRLA) Programs operated by TDMHMR as authorized by the Health Care Financing Administration in accordance with §1915(c) of the Social Security Act. The rule as adopted is intended to improve the services provided to a consumer who selects a newly enrolled provider by increasing the provider's knowledge about the requirements for participation as a program provider. The new rules also allow the department to terminate a provider agreement with a provisionally certified provider that has not been certified within the time frames specified in the rules to ensure that a provider remains knowledgeable about and able to meet current program standards. To ensure the consistency of provider qualifications, the conditions under which the department will approve the assignment of a provider agreement are formally defined.

All references to time periods expressed in "days" have been changed to "calendar days" for consistency with other sections of the rules. Language has been changed in §419.710(b) to require a program provider to notify TDMHMR at least 30 days, rather than 60 days, prior to the proposed assignment of its provider agreement. Language has been revised in §419.710(f) to allow TDMHMR to place a vender hold on a provider upon receiving a provider's notice of proposed assignment of its provider agreement. Language has been added in §419.710(f)(5) to provide that TDMHMR will release a vendor hold if an assignment is not approved.

Testimony was provided by Private Providers Association of Texas (PPAT), Austin, at a public hearing held on February 19, 1999, in TDMHMR Central Office, Austin.

Written comments were submitted by Parent Association for the Retarded of Texas (PART), Austin; a parent of a state school resident, Garland; Avondale House, Houston; EduCare, Austin; Private Providers Association of Texas (PPAT), Austin; Richmond State School, Richmond; and Big Spring State Hospital, Big Spring.

A commenter recommended adoption of the subchapter as proposed and noted that the formalized enrollment process, orientation for potential providers, criteria for accepting application packets, duration of the provisional certification, and assignment of a waiver provider agreement assist a potential provider in preparing to provide services. The department appreciates the commenter's support of the rules.

Regarding §419.705(b)(1)(B)(i), two commenters recommended replacing the term "developmental disabilities" with the term "related conditions" in specifying the work experience requirements of the employee or contractor responsible for managing and overseeing direct services. The commenters stated that use of the broader term "developmental disabilities" exceeds the department's authority, which is to serve persons with mental retardation or related conditions. The department responds that "related conditions" are a subset of the larger category of developmental disabilities and that experience in serving persons with developmental disabilities has practical applicability to planning and delivering services to persons with mental retardation and related conditions. The work experience required in this section does not permit the department to serve a broader population than that authorized by state law.

One commenter stated that the requirement in §419.707(a) for providers to obtain a Home and Community Support Services Agency (HCSSA) license is burdensome, expensive, and does not enhance the quality of services. The commenter suggested that the licensure standard be incorporated into the Home and Community-based Services (HCS) standards to eliminate a second set of standards, license, and surveys. The department responds that TDMHMR waiver program providers are required to obtain and maintain a HCSSA license under the Texas Health and Safety Code, Chapter 142, Subchapter A (relating to Home and Community Support Services License). Under agreement with the Texas Department of Health, a TDMHMR waiver program provider may be deemed as meeting the licensure requirements if the provider serves only persons enrolled in a waiver program certified and monitored by TDMHMR. Although this agreement does not eliminate the requirement for obtaining the license, it does exclude duplicative surveys under two sets of standards.

With regard to §419.707(a), two commenters recommended that the 270-day time period for submitting a provisionally certified provider's HCSSA license be shortened because it is too long for consumers to be served by a provisionally certified provider. The department responds that the 270-day time period allows the provisionally certified provider adequate time to obtain its initial HCSSA license. Further, consumers may not enroll with or receive waiver program services from a provider until the provider has a current HCSSA license and enters into a provider agreement with the department.

With regard to §419.708, a commenter questioned the value of TDMHMR terminating a waiver program provider agreement with provisionally certified providers only because a specified time period has elapsed. The commenter suggested alternatives that would allow a provider to retain the provisional certification status without time limits. The department declines to revise the requirements as recommended because the section is intended to provide a mechanism for the department to end a provider agreement with a provider that fails to enroll an eligible consumer and, hence, fails to achieve certified status within the time period specified. The department considers the time periods reasonable and realistic for providers while ensuring that consumers are able to enroll with a provider that can meet current program standards.

Concerning the same section, two other commenters recommended that the time periods contained in the section be shortened to ensure the safety of the individuals served. The department responds that the time periods give a new provider enrolling under the requirements of this rule, as well as a current provisionally certified provider, a reasonable amount of time to enroll its first consumer. In all circumstances, the rule requires an initial on-site certification review by the department or its designee no less than 120 calendar days following the enrollment of the first consumer. This 120-day time frame represents the maximum time in which the department or its designee must conduct the initial on-site certification review and allows the department to review sufficient service delivery data to determine if the initial 12-month certification should be granted. The department notes that meeting the provisional certification requirements, as set forth in §419.706(c), helps ensure that providers are prepared to serve consumers. Furthermore, prior to the initial certification review, the local mental retardation authority that assisted the consumer and LAR in selecting a provider remains available to assist the consumer and LAR, if necessary, after enrollment. Also, when a consumer moves from a state school to waiver services a regional monitor visits the consumer within 30 days of the move. The department is currently developing a process to require that department staff visit the first consumer enrolled in a provisionally certified provider's program to ensure the health and welfare of the consumer prior to the certification review visit.

Two commenters requested that the requirement in §419.710(b) for a program provider to notify TDMHMR 60 days prior to the date the provider proposes to assign its provider agreement be reduced to 30 calendar days. One of the commenters noted that a 30-day time period for finalizing such an assignment reflects current industry practice. The department responds that it has revised the time period in §419.710(b) to allow 30 calendar days to notify TDMHMR of a proposed assignment.

Two commenters disagreed with the provisions in §419.710(c)(3) which would hold the assignor and assignee jointly and severally liable for liabilities or obligations that arise from actions, events, or conditions that existed prior to the effective date of an assignment of a waiver program provider agreement. The commenters also disagreed with the provisions in §419.710(g) which would allow the recoupment of Medicaid payments from the assignor or assignee for liabilities or obligations arising from any act, event, or condition which occurred or existed prior to the effective date of the assignment. The commenters recommended that the language be revised to reflect that the assignor would be held solely responsible for actions, events, or conditions occurring prior to the effective date of the provider agreement assignment. The commenters reasoned that the provisions would impose undue delays in accomplishing an assignment transaction. One of the commenters stated that it would be unnecessary to also hold the assignee responsible for such circumstances because the department's interests would be adequately protected by the provisions in §419.710(f) which allow the department to impose a vendor hold on payments to the assignor until all audit exceptions are resolved. The same commenter requested that the department suspend implementation of the rules until a meeting could be held with the department to discuss reasonable alternatives to the proposal.

The department responds that it declines to make the recommended change because simply holding the assignor liable or withholding the assignor's Medicaid payments will not adequately protect the department from potential liabilities of the assignor. Even with 30 days' notice of an assignment, the amount of Medicaid payments that the department will be able to place on vendor hold may not be adequate to cover the liabilities. Additionally, the department may not be able to recover funds from the assignor beyond those placed on vendor hold because, after the date of the assignment, the assignor may not have recoverable assets or even exist as a business entity. To adequately protect its interests, the department must hold the assignee responsible for liabilities arising prior to the effective date of the assignment because it is the assignee, in the process of deciding whether to purchase the waiver program provider agreement from the assignor, that is in the best position to carefully investigate and consider potential liabilities related to the provider agreement. Furthermore, it is reasonable to expect the assignee and assignor to resolve any issues about potential liabilities within the terms of their purchase agreement. In response to the commenter's concerns about §419.710(g), the department believes that its interests in enforcing the assignee's liability are best protected by recouping Medicaid payments from the assignee. The department declines to postpone adoption of the rules.

A commenter expressed concern regarding §§419.710(c)(3) and 419.710(g) because the sections impede or effectively eliminate the acquisition of poor quality or financially unstable providers by providers known to have a solid record of service excellence and organizational stability. The department responds that it is not necessary to rely on the assignment of a provider agreement to resolve the poor performance of some providers - that is the purpose of the certification review process as described in department rules.

A commenter noted that in the situation when a provider has failed and is terminating services, the proposed rules could impede the smooth transition of consumers to a stable provider. Regarding the same situation, another commenter stated that if the consumers are at risk, the potential for liability may be so great that no responsible provider will assume the obligations of the provider agreement, leaving the department with no options favorable for the consumers. The department responds that in either situation, the transition of consumers to another provider does not have to occur through an assignment of contract process - a smooth and successful transition can be accomplished by following procedures the department has established for transferring consumers to other providers.

The commenter noted the provisions in the rules "address extremely isolated situations" and impose additional requirements which will unnecessarily complicate and interfere with the transaction of future assignments. The department responds that it is responsible for protecting its interests in all situations.

Two commenters stated that they had no comment.

The new sections are adopted under the Texas Health and Safety Code, §532.015(a), which provides TDMHMR with broad rulemaking authority; the Texas Government Code, §531.021(a), and the Texas Human Resources Code §32.021(a), which provide the Texas Health and Human Services Commission (THHSC) with the authority to administer the federal medical assistance (Medicaid) program in Texas; Acts 1995, 74th Texas Legislature, Chapter 6, §1, (Senate Bill 509), which clarifies the authority of THHSC to delegate the operation of all or part of a Medicaid program to a health and human services agency; and the Human Resources Code, §32.021(c), which provides an agency operating part of the Medicaid program with the authority to adopt necessary rules for the proper and efficient operation of the program. THHSC has designated TDMHMR as the operating agency for selected Medicaid waiver programs.

§419.708.Provider Certification.

No later than 120 calendar days following TDMHMR's approval of the enrollment of the first consumer in a provisionally certified provider's program, TDMHMR or its designee conducts a certification review in accordance with Chapter 409, Subchapter D of this title (relating to Home and Community-based Services), Chapter 409, Subchapter E of this title (relating to Home and Community-based Services - OBRA), or Chapter 409, Subchapter L of this title (relating to Mental Retardation Local Authority Program), as applicable.

TDMHMR may terminate the waiver program provider agreement of a provisionally certified provider that is not certified within 540 calendar days following the effective date of the waiver program provider agreement.

TDMHMR may terminate the waiver program provider agreement of a provisionally certified provider that was provisionally certified prior to the effective date of this subchapter but is not certified within 365 calendar days following the effective date of this subchapter.

A program provider whose waiver program provider agreement has been terminated in accordance with subsections (b) or (c) of this section must re-apply to enroll as a program provider in accordance with this subchapter.

§419.710.Waiver Program Provider Agreement Assignment.

No assignment of a waiver program provider agreement is effective until it is approved in writing by TDMHMR. The effective date of the assignment may not precede the date of TDMHMR's approval of the assignment.

A program provider must notify TDMHMR Medicaid Administration in writing at least 30 calendar days prior to the proposed assignment of its waiver program provider agreement. This notification must include the legal name of the proposed assignee, proposed date of the assignment, and the provider vendor number. If the program provider fails to provide this notification in a timely manner, approval of the assignment may be delayed.

Upon approval of the assignment, the program provider (hereafter referred to as the assignor) and the assignee, as indicated, are subject to the following provisions.

The assignee must keep, perform and fulfill all of the terms, conditions and obligations that must be performed by the assignor under the provider agreement and this subchapter.

The assignee is subject to all pending conditions which exist against the assignor, including but not limited to, any plan of correction, audit exception, vendor hold, or proposed contract termination.

The assignor and the assignee are jointly and severally liable to TDMHMR for any liabilities or obligations that arise from any act, event, or condition which occurred or existed prior to the effective date of the assignment and which is identified in any survey, review, or audit conducted by TDMHMR.

The assignor must complete and submit billing claims to TDMHMR for services provided prior to the approval date of the assignment in accordance with state rules.

The assignee must complete the enrollment/transfer process within 95 calendar days of the effective date of the assignment if any consumer requests to transfer into or from the assignor's program or any initial enrollments into the assignor's program are pending as of the effective date of the assignment;

The assignor must give written notification to each consumer or the consumer's LAR in the assignor's program of the proposed assignment, the proposed effective date of the assignment and of the consumer's option to transfer to another program provider.

The assignee must retain written documentation signed by each consumer or the consumer's LAR verifying that the notification was received and indicates the consumer's or LAR's choice whether to receive services from the assignee after the assignment is effective or to transfer to another program provider.

TDMHMR does not approve an assignment unless:

the proposed assignee holds a current waiver program provider agreement with TDMHMR or is eligible to enter into a provider agreement with TDMHMR as specified in §419.707(a) of this title (relating to Provider Agreement);

consumers are enrolled and receiving services or individuals are pending enrollment (as indicated by the TDMHMR Automated Enrollment and Billing System) in the assignor's program; and

the assignor and the proposed assignee submit an assignment agreement to TDMHMR that includes:

a statement that the assignor and assignee agree to the provisions set forth in subsection (c) of this section;

the effective date of the assignment, the name and address of the assignor and assignee and the provider vendor number to be assigned;

a statement that the assignment is subject to and contingent upon TDMHMR's written approval of the assignment or the assignment is void;

the signatures of the authorized representatives of the assignor and the assignee acknowledged before a notary public;

a blank space for TDMHMR's representative to sign indicating approval of the assignment agreement; and

any other provision required by law to make the assignment agreement legally enforceable.

TDMHMR may disapprove an assignment for good cause including, but not limited to:

a vendor hold on Medicaid payments is currently in effect for a program operated by the proposed assignee; or

a proposed contract/provider agreement termination is in effect for a program operated by the proposed assignee.

On the date TDMHMR receives notice of a proposed assignment in accordance with subsection (b) of this section, TDMHMR may place a vendor hold on Medicaid payments to the assignor until all findings made from a survey, billing and payment review or audit which has been or is being conducted by TDMHMR are resolved.

At its discretion, TDMHMR may allow an assignor to obtain a surety bond or an irrevocable letter of credit in order to release the vendor hold prior to completing a survey, billing and payment review, or audit.

The surety bond or irrevocable letter of credit must be for a period of three years. The three-year period begins with the effective date of the assignment. TDMHMR specifies the amount of the surety bond or letter of credit.

The surety bond or irrevocable letter of credit must be in a format acceptable to TDMHMR and must not include requirements for TDMHMR to:

return the original bond or irrevocable letter of credit prior to receipt of payment; or

submit a sight draft or any other draft or demand requirement other than TDMHMR's letter demanding payment.

If the assignor submits an acceptable surety bond or irrevocable letter of credit to TDMHMR, TDMHMR releases the vendor hold.

If TDMHMR does not approve the proposed assignment, the vendor hold is released.

TDMHMR may recoup Medicaid payments from the assignor or assignee for liabilities or obligations arising from any act, event, or condition which occurred or existed prior to the effective date of the assignment and which is identified in a survey, review, or audit conducted by TDMHMR.

If TDMHMR approves an assignment, TDMHMR or its designee conducts an on-site certification review within 120 calendar days of the effective date of the assignment in accordance with Chapter 409, Subchapter D of this title (relating to Home and Community-based Services), Chapter 409, Subchapter E of this title (relating to Home and Community-based Waiver Services - OBRA), or Chapter 409, Subchapter L of this title (relating to Mental Retardation Local Authority Program), as applicable.

This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority.

Filed with the Office of the Secretary of State on April 26, 1999.

Chair, Texas MHMR Board

Texas Department of Mental Health and Mental Retardation

Effective date: May 16, 1999

Proposal publication date: February 12, 1999

For further information, please call: (512) 206-4516

Part VIII. Interagency Council on Early Childhood Intervention

Chapter 621. Early Childhood Intervention

Subchapter B. Early Childhood Intervention Service Delivery

25 TAC §621.21

The Interagency Council on Early Childhood Intervention (ECI) adopts an amendment to §621.21, concerning purpose, without changes to the proposed text as published in the February 26, 1999, issue of the Texas Register (24 TexReg 1299) and will not be republished.

The amendment is adopted to reflect changes in statutory revisions by the 75th Legislature.

No comments were received regarding adoption of the amendment.

The amendment is adopted under the Human Resources Code, Chapter 73, which provides the Interagency Council on Early Childhood Intervention with the authority to promulgate rules consistent with the Code.

This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority.

Filed with the Office of the Secretary of State on April 26, 1999.

Donna Samuelson

Deputy Executive Director

Interagency Council on Early Childhood Intervention

Effective date: May 16, 1999

Proposal publication date: February 26, 1999

For further information, please call: (512) 424-6750

25 TAC §621.23

The Interagency Council on Early Childhood Intervention (ECI) adopts an amendment to §621.23, concerning Service Delivery Requirements for Comprehensive Services, without changes to the proposed text as published in the November 27, 1998, issue of the Texas Register (23 TexReg 11897) and will not be republished.

The amendment is adopted as a result of the rule review process. The amendment will update the rule. Elsewhere in this issue of the Texas Register , the ECI has adopted the review of the following sections: §§621.21-621.33. This review is in accordance with the Appropriations Act of 1997, HB 1, Article IX, Section 167.

No comments were received regarding adoption of the amendment.

The amendment is adopted under the Human Resources Code, Chapter 73, which provides the Interagency Council on Early Childhood Intervention with the authority to promulgate rules consistent with the Code.

This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority.

Filed with the Office of the Secretary of State on April 26, 1999.

Donna Samuelson

Deputy Executive Director

Interagency Council on Early Childhood Intervention

Effective date: May 16, 1999

Proposal publication date: November 27, 1998

For further information, please call: (512) 424-6750

Chapter 621. Early Childhood Intervention

The Interagency Council on Early Childhood Intervention (ECI) adopts amendments to §§621.25-621.31, 621.41-621.43, 621.45, 621.46, 621.48, and 621.49, concerning Early Childhood Intervention Service Delivery and Procedural Safeguards and Due Process Procedures, without changes to the proposed text as published in the January 22, 1999, issue of the Texas Register (24 TexReg 363) and will not be republished.

The amendments are adopted as a result of the rule review process. The amendments will update existing regulations. Elsewhere in this issue of the Texas Register , the ECI has adopted the review of the following sections: §§621.41-621.43, 621.45, 621.46, 621.48, and 621.49.

No comments were received regarding adoption of the amendments.

Subchapter B. Early Childhood Intervention Service Delivery

25 TAC §§621.25-621.31

The amendments are adopted under the Human Resources Code, Chapter 73, which provides the Interagency Council on Early Childhood Intervention with the authority to promulgate rules consistent with the Code.

This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority.

Filed with the Office of the Secretary of State on April 26, 1999.

Donna Samuelson

Deputy Executive Director

Interagency Council on Early Childhood Intervention

Effective date: May 16, 1999

Proposal publication date: January 22, 1999

For further information, please call: (512) 424-6750

Subchapter C. Procedural Safeguards and Due Process Procedures

25 TAC §§621.41-621.43, 621.45, 621.46, 621.48, 621.49

The amendments are adopted under the Human Resources Code, Chapter 73, which provides the Interagency Council on Early Childhood Intervention with the authority to promulgate rules consistent with the Code.

This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority.

Filed with the Office of the Secretary of State on April 26, 1999.

Donna Samuelson

Deputy Executive Director

Interagency Council on Early Childhood Intervention

Effective date: May 16, 1999

Proposal publication date: January 22, 1999

For further information, please call: (512) 424-6750

Subchapter D. Early Childhood Intervention Advisory Committee

25 TAC §621.62

The Interagency Council on Early Childhood Intervention adopts an amendment to §621.62, concerning Early Childhood Intervention Advisory Committee, without changes to the proposed text as published in the January 22, 1999, issue of the Texas Register (24 TexReg 369) and will not be republished.

This section was previously adopted on an emergency basis to comply with federal regulations. The emergency adoption was published in the January 22, 1999, issue of the Texas Register (24 TexReg 339).

This section amends the size, composition and voting status of members of its Advisory Committee.

No comments were received regarding adoption of the amendment.

The amendment is adopted under the Human Resources Code, Chapter 73, which authorizes the Interagency Council on Early Childhood Intervention to establish rules regarding services provided for children with developmental delays.

This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority.

Filed with the Office of the Secretary of State on April 26, 1999.

Donna Samuelson

Deputy Executive Director

Interagency Council on Early Childhood Intervention

Effective date: May 16, 1999

Proposal publication date: January 22, 1999

For further information, please call: (512) 424-6750

25 TAC §621.64

The Interagency Council on Early Childhood Intervention (ECI) adopts an amendment to §621.64, concerning Advisory Committee Procedures, without changes to the proposed text as published in the November 27, 1998, issue of the Texas Register (23 TexReg 11902) and will not be republished.

The amendment was necessary in subsection (e). There is a reference to Article V, when in fact the proper reference is Article IX.

No comments were received regarding adoption of the amendment.

The amendment is adopted under the Human Resources Code, Chapter 73, which provides the Interagency Council on Early Childhood Intervention with the authority to promulgate rules consistent with the Code.

This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority.

Filed with the Office of the Secretary of State on April 26, 1999.

Donna Samuelson

Deputy Executive Director

Interagency Council on Early Childhood Intervention

Effective date: May 16, 1999

Proposal publication date: November 27, 1998

For further information, please call: (512) 424-6750

Subchapter E. Early Childhood Intervention Service Delivery for Milestones Services

25 TAC §§621.81-621.84

The Interagency Council on Early Childhood Intervention (ECI) adopts the repeal of §§621.81-621.84, concerning Early Childhood Intervention Service Delivery for Milestones Services, without changes to the proposed text as published in the February 26, 1999, issue of the Texas Register (24 TexReg 1299) and will not be republished.

The rules are no longer necessary and are therefore being repealed.

Elsewhere in this issue of the Texas Register the ECI is contemporaneously adopting the review of Subchapter E. Early Childhood Intervention Service Delivery for Milestones Services, §§621.81-621.84. This review is in accordance with the Appropriations Act of 1997, HB 1, Article IX, Section 167.

No comments were received regarding adoption of the repeals.

The repeals are adopted under the Human Resources Code, Chapter 73, which provides the Interagency Council on Early Childhood Intervention with the authority to promulgate rules consistent with the Code.

This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority.

Filed with the Office of the Secretary of State on April 26, 1999.

Donna Samuelson

Deputy Executive Director

Interagency Council on Early Childhood Intervention

Effective date: May 16, 1999

Proposal publication date: February 26, 1999

For further information, please call: (512) 424-6750