ADOPTED RULES An agency may take final action on a section 30 days after a proposal has been published in the Texas Register. The section becomes effective 20 days after the agency files the correct document with the Texas Register, unless a later date is specified or unless a federal statute or regulation requires implementation of the action on shorter notice. If an agency adopts the section without any changes to the proposed text, only the preamble of the notice and statement of legal authority will be published. If an agency adopts the section with changes to the proposed text, the proposal will be republished with the changes. TITLE 16. ECONOMIC REGULATIONS Part I. Railroad Commission of Texas Chapter 3. Oil and Gas Division Conservation Rules and Regulations 16 TAC sec.3.36 The Railroad Commission of Texas adopts an amendment to sec.3.36, with changes to the proposed text as published in the November 4, 1994, issue of the Texas Register (19 TexReg 8746). Adoption of the rule will expressly bring intentional releases of hydrogen sulfide under the provisions of sec.3.36, thereby protecting the public from an unreasonable risk of harm from exposure to hydrogen sulfide. The proposed amendments will require that operators notify the commission and activate their contingency plan prior to an intentional release of a potentially hazardous volume of hydrogen sulfide. Several commenters expressed concern that the rule was not clear as to the volume of a release that constitutes a "potentially hazardous volume" of hydrogen sulfide. The commission believes that proposed definition of "potentially hazardous volume" of hydrogen sulfide is adequate. However, the text of the definition has been moved for clarification. Several commenters stated that the proposed 48-hour advance notice on planned releases is excessive. The commission agrees. The notice requirement has been reduced to 12 hours in advance of planned intentional release, or as soon as possible in the event of an unplanned intentional release made in an emergency. Two commenters felt that a written report was not needed. The commission agrees in part and has modified the written report requirement to only those planned releases where there is injury to person or property as a result of the release. Several commenters stated that the requirements on planned releases should not apply if the release is flared. The commission disagrees. Flares can go out. If a potentially hazardous volume of hydrogen sulfide gas is being flared and the flare goes out, the general public could be put at risk of serious harm unless a contingency plan is activated. One commenter stated that the rule should have guidelines to govern when venting, as opposed to flaring, hydrogen sulfide gas would be permitted. The commission agrees. Language has been added to allow venting of a potentially hazardous volume of hydrogen sulfide gas upon a showing that such venting will not present an unreasonable risk of harm to the public. One commenter suggested that the rule allow for the calculation of a radius of exposure on intentional releases from pressurized vessels and pipelines using the known volume and release rate rather than using the absolute open-flow potential of the system as a whole. The commission agrees. Subsection (c)(3)(E) has been modified to allow for such a calculation. The following commenters expressed general support for the amendment to sec.3.36 with some recommended changes: Texas Independent Producers & Royalty Owners Association, Texas Mid-Continent Oil & Gas Association, and Permian Basin Petroleum Association. The following commenter supported the amendment to sec.3.36: North Texas Oil & Gas Association. The following commenters did not express support for or opposition to the amendment to sec.3.36, but did submit recommended changes: Association of Texas Intrastate Natural Gas Pipeline and Lone Star Gas Company. The following commenter expressed opposition to the amendment to sec.3.36 and provided recommended changes: Wagner & Brown, Limited. The amendment is adopted pursuant to Texas Natural Resources Code, sec.sec.81. 051, 81.052, 85.042, 85.202, 86.041, and 86.042, which authorize the commission to adopt rules to govern and regulate persons and their operations to prevent injury to persons and property. sec.3.36. Oil, Gas, or Geothermal Resource Operation in Hydrogen Sulfide Areas. (a) Applicability. Each operator who conducts operations as described in paragraph (1) of this subsection shall be subject to this section and shall provide safeguards to protect the general public from the harmful effects of hydrogen sulfide. This section applies to both intentional and accidental releases of hydrogen sulfide. (1)-(2) (No change.) (b) Definitions. (1)-(9) (No change.) (10) Potentially hazardous volume of hydrogen sulfide -A volume of hydrogen sulfide gas of such concentration that: (A) the 100 ppm radius of exposure is in excess of 50 feet and includes any part of a "public area" except a public road; or (B) the 500 ppm radius of exposure is greater than 50 feet and includes any part of a public road; or (C) the 100 ppm radius of exposure is greater than 3,000 feet. (11) Contingency plan-A written document that shall provide an organized plan of action for alerting and protecting the public within an area of exposure prior to an intentional release, or following the accidental release of a potentially hazardous volume of hydrogen sulfide. (12) Reaction-type contingency plan-A preplanned, written procedure for alerting and protecting the public, within an area of exposure, where it is impossible or impractical to brief in advance all of the public that might possibly be within the area of exposure at the moment of an accidental release of a potentially hazardous volume of hydrogen sulfide. (13) Definition of referenced organizations and publications. (A) ANSI-American National Standard Institute, 1430 Broadway, New York, New York 10018, Table I, Standard 253. 1-1967. (B) API-American Petroleum Institute, 300 Corrigan Tower Building, Dallas, Texas 75201, Publication API RP-49, Publication API RP-14E, Sections 1.7(c), 2.1(c) 4.7. (C) ASTM-American Society for Testing and Materials, 1916 Race Street, Philadelphia, Pennsylvania 19103, Standard D-2385-66. (D) GPA-Gas Processors Association, 1812 First Place, Tulsa, Oklahoma 74120, Plant Operation Test Manual C-1, GPA Publication 2265-68. (E) NACE-National Association of Corrosion Engineers, P.O. Box 1499, Houston, Texas 77001, Standard MR-01-75. (F) DOT-Department of Transportation, Office of Pipeline Safety, 400 Seventh Street, S.W., Washington, D.C. 20590, Title 49, Code of Federal Regulations, Parts 192 and 195. (G) OSHA-Occupational Safety and Health Administration, United States Department of Labor, 200 Constitution Avenue, NW, Washington D.C. 20270, Title 29, Code of Federal Regulations, Part 1910.145(c) (4)(i). (H) RRC-Railroad Commission of Texas, Gas Utilities Division, P.O. Drawer 12967, Capitol Station, Austin, Texas 78711, Gas Utilities Dockets 446 and 183. (c) General provisions. (1)-(2) (No change.) (3) The volume used as the escape rate in determining the radius of exposure shall be that specified in subparagraph (A) -(E) of this paragraph, as applicable. (A)-(D) (No change.) (E) For intentional releases from pipelines and pressurized vessels, the operator's estimate of the volume and release rate based on the gas contained in the system elements to be de-pressured. (4)-(7) (No change.) (8) Control and equipment safety provision: Operators subject to this provision shall install safety devices and maintain them in an operable condition or shall establish safety procedures designed to prevent the undetected continuing escape of hydrogen sulfide. For intentional releases of a potentially hazardous volume of hydrogen sulfide gas, the gas must be flared unless permission to vent is obtained from the commission or its delegate. Venting will be allowed only upon a showing that the venting will not pose an unreasonable risk of harm to the public. (9) Contingency plan provision. (A) (No change.) (B) The purpose of the contingency plan shall be to provide an organized plan of action for alerting and protecting the public prior to an intentional release, or following the accidental release of a potentially hazardous volume of hydrogen sulfide. (C) The contingency plan shall be activated prior to an intentional release, or immediately upon the detection of an accidental release of a potentially hazardous volume of hydrogen sulfide. (D)-(M) (No change.) (N) The Railroad Commission District Office shall be notified as follows if the contingency plan is activated: (i) 12 hours in advance of an intentional release or as soon as a decision is made to release if such decision could not reasonably have been made more than 12 hours prior to the release. (ii) immediately in the case of an accidental release. (iii) as soon as possible before or after an unplanned intentional release made in an emergency situation to prevent a possible uncontrolled release. (O)-(Q) (No change.) (10)-(13) (No change.) (14) Accident notification. Operators shall immediately notify the appropriate Railroad Commission District Office of any accidental release of hydrogen sulfide gas of sufficient volume to present a hazard and of any hydrogen sulfide related accident. (d) Reports required. (1)-(2) (No change.) (3) Releases of, and accidents related to, hydrogen sulfide. The operator shall furnish a written report to the district office within ten days of any accidental release of hydrogen sulfide gas of sufficient volume to present a hazard and of any hydrogen sulfide related accident, whether it be from an accidental or intentional release. (e) (No change.) This agency hereby certifies that the rule as adopted has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority. Issued in Austin, Texas, on March 14, 1995. TRD-9503336 Mary Ross McDonald Assistant Director, Legal Division, Gas Utilities/LP Gas Railroad Commission of Texas Effective date: April 7, 1995 Proposal publication date: November 4, 1994 For further information, please call: (512) 463-6832 TITLE 19. EDUCATION Part II. Texas Education Agency Chapter 137. Professional Educator Preparation and Certification Subchapter H. Alternative Certification of Teachers 19 TAC sec.137.231 The Texas Education Agency (TEA) adopts an amendment to sec.137.231, concerning requirements for the alternative certification of teachers, with changes to the proposed text as published in the November 22, 1994, issue of the Texas Register (19 TexReg 9265). The amendment is necessary to provide enhanced safeguards that will help ensure the quality of professionals teaching in Texas classrooms. The amendment clarifies the following issues regarding alternative teacher certification: program administration and supervision; applicant screening procedures; intern preassignment training requirements and documentation; mentor selection, training, and assignment to intern; scheduled time for mentors and interns; advisory committee composition, function, and responsibilities; program assessment procedures; and appropriateness of college coursework to meet the needs of intern teachers. The change to sec.137.231(b)(3)(C) adds language to ensure teacher participation in an advisory committee to a collaborative that is developing a plan for an alternative teacher certification program (ACP). The change to sec.137.231(b)(4) substitutes the word "must" for the word "shall" to strengthen the rule text regarding approval to increase the maximum number of interns in an ACP. The change to sec.137.231(b)(6) adds language clarifying that the required preassignment and ongoing training shall apply to interns. The change to sec.137.231(b)(9)(B) adds language requiring a minimum number of hours of mentor training to ensure mentors receive adequate training. The change to sec.137.231(c)(3) adds the Pre-Professional Skills Test (P-PST) to the basic skills test requirement to accommodate out-of-state candidates. The text of sec.137.231(c)(6) is reformulated to clarify requirements concerning an integrated, field-based approach to delivery of instruction and training. The following comments were received regarding adoption of the amendment. The Association of Texas Professional Educators (ATPE) recommended that the rule require greater teacher representation on the advisory committee. The SBOE added language to sec.137.231(b)(3)(C) to require that no one category of representation on the advisory committee be larger than the K-12 teacher representation. The following comments were received regarding mentor training. The ATPE recommended that the rule require a minimum of 12 hours of mentor training to ensure consistency across ACPs. The following commentators opposed requiring a minimum of 12 hours of mentor training: Texas Alternative Certification Association (TACA), Region 4 Education Service Center (ESC), Region 10 ESC, Region 18 ESC, University of Texas Pan American, Dallas Independent School District (ISD), Irving ISD, Texas Association of School Personnel Administrators (TASPA), and one member of the public. The SBOE added language to sec.137.231(b)(9)(B) to require that the mentor training program be delivered in a minimum of 12 hours and include best practices for supporting and assisting interns throughout the internship period. The board believed that 12 hours of mentor training was necessary to ensure consistency among programs and adequate delivery of content in competency areas. The following comments were received regarding preassignment training. The ATPE recommended that the rule specify the number of semester hours and student contact hours an ACP must require to ensure a minimum amount of training before classroom assignment. The ATPE, Texas State Teachers Association (TSTA), and the Texas Federation of Teachers (TFT) recommended that the rule require 45 clock hours of student contact experience, but that the rule be flexible with regard to qualifying experiences. The following commentators opposed requiring 45 clock hours of student contact experience: TACA, Region 4 ESC, Region 10 ESC, Region 18 ESC, Region 20 ESC, University of Texas Pan American, Dallas ISD, Irving ISD, TASPA, and five members of the public. The TACA recommended that the rule require 20 clock hours of student contact experience. The SBOE modified the rule to require the ACP plan to include preassignment training incorporating a minimum of 20 clock hours of student contact experiences. The student contact experiences may entail a variety of classroom- based experiences that are locally designed and approved by the committee of stakeholders. In addition, the rule requires a minimum of six semester hours of course work or a combination of semester hours and equivalent contact hours to be completed before assignment; and a minimum of six semester hours of course work or a combination of semester hours and equivalent contact hours to be completed before certification. The following commentators recommended extending the time line for implementing the amended rule to the 1996-1997 intern cycle: TACA, Region 4 ESC, Region 10 ESC, Region 18 ESC, University of Texas Pan American, Dallas ISD, Irving ISD, TASPA, and ATPE. The SBOE agreed with this time line because it will allow ACPs ample time to understand and prepare for the new requirements and to give notice to prospective applicants. The following commentators requested that, in sec.137.231(c)(3), the list of acceptable basic skills tests be expanded to include the Functional Academic Skills Test (FAST), Pre-Professional Skills Test (P-PST), and Texas Examination for the Certification of Administrators and Teachers (TECAT): TACA, Region 4 ESC, Region 10 ESC, Region 18 ESC, University of Texas Pan American, Dallas ISD, Irving ISD, TASPA, and ATPE. The SBOE added the P-PST to the list of tests to accommodate out-of-state candidates who enter an ACP. The board did not add the TECAT because certified teachers who have taken the TECAT have already given evidence of basic skills and, therefore, are exempt from this provision of the rule. The FAST was not included based on concerns related to test security. The TACA recommended that, in sec.137.231(c)(4), the responsibility for providing evidence of a teacher's criminal record clearance be shifted from the teacher to the school district. The SBOE did not make the change. By law, school districts already must perform criminal records checks for hiring purposes. Section 137.231(c)(4) would allow an intern to provide evidence of criminal record clearance outside the State of Texas. The amendment is adopted under the Texas Education Code, sec.13.035, which authorizes the State Board of Education to provide by rule for teacher and administrator certification programs as an alternative to teacher education programs. sec.137.231. Requirements for the Alternative Certification of Teachers. (a) General provisions. Approval of alternative certification of teachers by the State Board of Education (SBOE) is based on the following requirements. (1) Alternative certification of teachers shall be a collaborative program among public schools, regional education service centers (ESC), and institutions of higher education and delivered through Texas public schools. (2) The collaborative entities shall develop and implement a comprehensive field-based teacher preparation program based on the state-approved proficiencies for teachers, content competencies, current research, and best practice. (3) The collaborative program shall have internal and external assessment procedures that focus on attainment of the proficiencies, student learning, and continuous improvement of program content and delivery. (4) The program administrator or the district superintendent shall recommend an individual for teacher certification to the commissioner of education based on satisfactory completion of requirements of the approved program. (5) Certificates that may be earned through an alternative certification program include any certificate or endorsement for a teacher that may be earned through the completion of an approved teacher education program for which a bachelor's degree is required. The following additional certificate areas are unique to alternative certification: Grades prekindergarten-6 elementary education, Grades prekindergarten-6 elementary bilingual, Grades prekindergarten-12 English as a second language (ESL), and Grades prekindergarten-12 generic special education. (6) An individual admitted into an alternative teacher certification program that has been approved under this section shall be issued a probationary certificate that is valid for one calendar year. The probationary certificate may be extended for one additional year only according to the provisions of the Texas Education Code, sec.13.306. (b) Requirements for an approved plan. A collaborative that prepares teachers, as described in subsection (a)(1) of this section, must submit a collaboratively developed plan for SBOE approval before implementing the plan. The plan must address the following. (1) Participating school districts, colleges, or universities must be accredited. (2) The program shall address the educational needs of all children. (3) A committee consisting of the major stakeholders shall assist and provide evidence of shared accountability in the design, delivery, evaluation, and major policy decisions of the program. The committee shall: (A) include teachers, administrators, ESC staff, faculty and administrators from institutions of higher education; (B) reflect the cultural diversity of the region served; (C) require that the teacher representation reflect each certification area offered and that no one category representation be larger than the K-12 teacher representation; and (D) meet on a regular basis to review program design and implementation and make program refinements based on evaluation data. (4) The plan must include a description of available resources and an approved program budget that indicates commitment through adequate funding for establishing, implementing, evaluating, and maintaining the program. The plan shall indicate the maximum number of interns to be admitted to the program to assess adequacy of resources allocated for program operation. The commissioner of education must approve any increase beyond the SBOE-approved maximum number of interns to be admitted into the program. (5) The plan must designate a program administrator with adequate, qualified staff to assure appropriate planning, screening, training, supervision, and assessment as indicated in a ratio of supervisors to interns. Lines of responsibility and communication with all entities involved must be clearly delineated. (6) The plan must include a calendar of program activities for the duration of each school year for which the program is approved. The calendar must include a deadline for accepting candidates into a cycle to assure adequate time for preassignment screening and preassignment and ongoing training for interns. (7) The alternative certification plan must provide evidence of: (A) state-approved teacher proficiencies integrated throughout the preparation program; (B) a comprehensive delivery system through which proficiencies are acquired; (C) a variety of teaching and learning experiences integrated into the delivery system; and (D) an ongoing, comprehensive performance assessment system for the teacher candidates. (8) The program must include: (A) a supervised internship of at least one calendar year under the mentorship of an experienced, certified teacher or teachers in the subject area or areas or at the level for which the intern is to be certified; and (B) provisions for release from teaching duties on a regularly scheduled basis: (i) for each intern to observe the teaching of the mentor teacher or other teachers and to confer with the mentor teacher; and (ii) for each mentor teacher to observe, coach, and formatively assess the teaching of the intern. (9) The program must provide for the selection, training, and support of mentor teachers. (A) Selection criteria must include best practices for identifying mentor teachers. (B) An orientation to the roles and responsibilities of mentoring shall be provided to each mentor upon assignment as a mentor and no later than the intern's first week of teaching. The mentor training program shall be delivered in a minimum of 12 hours and include best practices for supporting and assisting interns throughout the internship period. The training shall include the following areas: adult learners, stages of teacher growth and development, self- reliance and motivation, stress management, interpersonal skills, formative assessment strategies, counseling, peer coaching and direct support, communication with parents, school culture, and cultural diversity. (C) The program plan shall provide a process for regularly scheduled times for each mentor to communicate with program staff to discuss the intern's performance and progress. (10) The program plan must provide evidence of equity in recruiting and retaining interns, especially among underrepresented populations, and a system of ongoing counseling, guidance, and support for interns. (11) The program plan must delineate a comprehensive method for screening, admission, training, evaluation of intern performance, and recommendation for certification. (12) The plan must provide evidence of ongoing, internal and external program assessment used to assure quality and continuous improvement. (13) Follow-up data that attest to program and intern effectiveness must be maintained. (c) Requirements for admission, assignment, and certification. Each program must assure and document that an applicant meets the following minimum requirements for admission as an intern to the alternative teacher certification program. (1) The program shall publish and disseminate specific admission and retention policies for program entry and internship, including academic and performance standards, as well as prerequisite field experience. (2) Each applicant must hold a bachelor's or a higher level degree from an institution of higher education that was accredited or otherwise approved by a state department of education, a recognized governmental entity, or a recognized regional accrediting organization at the time the degree was conferred. Each applicant must have maintained a grade point average of no less than 2.50 on a four-point system on all semester hours attempted and on semester hours required for the certificate as specified in paragraph (5)(A) -(F) of this subsection. (3) Applicants must possess basic skills in mathematics, reading, and writing as evidenced by acceptable scores on the state-mandated basic skills test; or the pre-professional skills test (P-PST) for out-of-state candidates. (4) Applicants shall give evidence of state or national criminal record clearance before classroom assignment as interns. (5) Applicants must have appropriate semester hours of transcript credit in a subject or combination of subjects to be taught and related to the certificate to be earned. (A) For the Grades 6-12 secondary certificate, applicants must have 24 semester hours in a subject included in Chapter 75 of this title (relating to Curriculum) for the secondary level of assignment. Twelve semester hours must be upper division. (B) For the Grades prekindergarten-6 elementary certificate, applicants must have 24 semester hours in a combination of subjects taught in the elementary school that must include English, mathematics, a natural science, and a subject in the social studies. Applicants shall have at least three semester hours in each of the four areas. (C) For the Grades prekindergarten-6 elementary bilingual certificate, applicants must have evidence of oral and written proficiency on a validated test of English and the language of the target population for bilingual education assignments. In addition, applicants must have 24 semester hours in a combination of subjects taught in the elementary school that must include English, mathematics, a natural science, and a subject in the social studies. Applicants shall have at least three semester hours in each of the four areas. (D) For the Grades prekindergarten-12 ESL certificate, applicants must have 18 semester hours in English, six of which must be upper division. (E) For the Grades prekindergarten-12 generic special education certificate, applicants must have 24 semester hours in a combination of subjects taught in the elementary school that must include English, mathematics, a natural science, and a subject in the social studies. Applicants shall have at least three semester hours in each of the four areas. (F) Courses that focus on topics closely related to the semester hour requirements listed in subparagraphs (A)-(E) of this paragraph may be accepted for admission to the alternative certification program; however, such substitutions shall not exceed six hours for the Grades 6-12 certificate or three semester hours for all other certificates. (6) The program shall identify specific performance indicators consistent with state-adopted proficiencies and competencies to determine an individual's preparedness for classroom assignment, a curriculum for continued development during ongoing training, and an individual's readiness for licensure at the completion of internship. The program shall include: (A) use of current research and best practice that focus on teaching, learning, and student achievement through a planned sequence of field-based experiences that integrate knowledge with application; (B) a variety of student centered activities or services that are field-based, support the proficiencies, and that also provide experiences in public schools that reflect diverse cultural, socioeconomic, and grade level environments; (C) curriculum and instructional knowledge and applications that include strategies to work with culturally diverse populations; (D) preassignment training incorporating: (i) a minimum of 20 clock hours of student contact experiences. The student contact experiences may entail a variety of classroom-based experiences that are locally designed and approved by the committee of stakeholders under subsection (b)(3) of this section; and (ii) a minimum of six semester hours of course work or a combination of semester hours and equivalent contact hours; and (E) six semester hours of course work or a combination of semester hours and equivalent contact hours to be completed before certification. (7) An intern must have acceptable scores on appropriate state-adopted examinations of professional education and content knowledge in the teaching fields or delivery systems related to the certificate sought and the level of assignment. (8) An intern must meet full appraisal requirements of the state and the local district under sec.149.41 of this title (relating to General Provisions). (9) An intern must meet the performance levels as determined by the collaborative. (d) Procedures for approval, review, and reapproval. (1) An entity that chooses to prepare teachers using the alternative certification process must direct the program administrator to submit to the commissioner of education, before implementing a program, a collaboratively developed plan that specifies the means by which the entity shall fulfill the requirements for an approved plan under subsections (b) and (c) of this section. (2) The commissioner of education may approve plans for alternative teacher certification. Initial approval of alternative teacher certification plans shall not extend more than one year. Subsequent approval shall be contingent on satisfactory performance under the state-approved accountability system. The SBOE shall consider such performance when granting reapproval requests. (3) The administrator of an approved alternative teacher certification program must submit to the commissioner of education an annual report that includes the names of candidates in the program and other information that may be required, including results of internal monitoring, review, and assessment of the program. (4) Alternative teacher certification programs are subject to review by the Texas Education Agency (TEA). (e) Alternative certification program options. (1) During the internship, the intern may pursue an additional certificate or additional subject areas at the same level of assignment by taking the appropriate state-mandated test for certification, provided that screening and all other requirements for the additional certificate or subject areas under this section are met. (2) If an intern fails to complete all training and certification requirements within the internship year, the program administrator may apply to retain the intern in the alternative certification program only until the deficiencies are met, but not to exceed one additional year. The program administrator shall provide rationale for extension and the conditions under which requirements must be met. (3) If the sponsor of an alternative certification program does not seek reapproval of the program or SBOE does not grant a reapproval request, interns currently enrolled in the program are provided an opportunity to complete requirements within a reasonable time. This agency hereby certifies that the rule as adopted has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority. Issued in Austin, Texas, on March 22, 1995. TRD-9503502 Criss Cloudt Executive Associate Commissioner, Policy Planning and Information Management Texas Education Agency Effective date: April 12, 1995 Proposal publication date: November 22, 1994 For further information, please call: (512) 463-9701 TITLE 22. EXAMINING BOARDS Part XI. Board of Nurse Examiners Chapter 217. Licensure and Practice 22 TAC sec.217.20 The Board of Nurse Examiners adopts new sec.217.20, concerning Minimum Procedural Standards During Peer Review, without changes in the proposed text as published in the February 3, 1995, issue of the Texas Register (20 TexReg 614). This rule is being adopted to comply with Article 4525b, Section 1A, passed during the 73rd Legislative Session which specifies that a peer review committee afford the registered nurse minimum due process. The Board's Nursing Practice Advisory Committee was charged in the summer of 1994 with developing rules defining minimum due process rights of the RN in peer review. A subcommittee consisting of one member of the advisory committee, legal counsels representing the Board of Nurse Examiners, Texas Nurses' Association, Texas Hospital Association, and a private RN attorney met and edited the committee's recommended draft rules. On January 4, 1995, the Advisory Committee then met, reviewed and recommended a draft for the Board's consideration. This rule defines the minimum due process rights of the RN within the Board's scope of authority. The Board received comments from the Texas Department of Mental Health and Mental Retardation, Austin; Texas Association for Home Care, Austin; and two letters from Methodist Hospital, Lubbock, signed by members of their peer review committee and various nursing directors. None of the commenters were opposed to the rule, but offered the following suggestions: Under sec.217.20(b)(1), a commenter suggested extending the minimum prehearing review from 30 to 45 days. Under subsection (b)(3), a commenter suggested the minimum preappearance review be shortened from 15 to 10 days. Two comments were received regarding sec.217.20(c) voicing opposition to the nurse's opportunity to appear before the committee and opposition to the nurse's opportunity to be represented by counsel. The agency has considered each comment in light of case law regarding due process requirements and has determined that no changes should be made in the provisions for the nurse's opportunity for personal appearance and parity of legal representation. Since comments regarding the notice interval were received both for shortening and lengthening the time, the agency has determined that the notice interval should not be changed. The new section is adopted under the Nursing Practice Act, (Texas Civil Statutes, Article 4514), sec.1, which provides the Board of Nurse Examiners with the authority and power to make and enforce all rules and regulations necessary for the performance of its duties and conducting of proceedings before it. This agency hereby certifies that the rule as adopted has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority. Issued in Austin, Texas, on March 22, 1995. TRD-9503517 Louise Waddill, Ph.D., R.N. Executive Director Board of Nurse Examiners Effective date: April 12, 1995 Proposal publication date: February 3, 1995 For further information, please call: (512) 835-8675 TITLE 28. INSURANCE Part II. Texas Workers' Compensation Commission Chapter 134. Guidelines For Medical Services, Charges, And Payments Subchapter K. Treatment Guidelines 28 TAC sec.134.1001 The Texas Workers' Compensation Commission adopts new sec.134.1001, concerning spine treatment guidelines, with changes to the proposed text as published in the September 20, 1994, issue of the Texas Register (19 TexReg 7326). The terms "guideline", "rule", and "section" are used interchangeably in this preamble and in the text of the rule. The majority of the revisions made to the rule were in response to public comment received, both in writing, and from testimony given by speakers at the public hearing held on January 12, 1995. These revisions are described in the summary of comments and responses portion of this preamble. Other revisions were made by staff and the commission for clarification purposes and also in response to public comments received: the word "medical" was added to (d)(1)(F); lead-in text was added to (e)(2)(A); the word "or" was removed from (e)(2)(A)(vi) and from (e)(3)(B)(v); a new subparagraph (Q) was added to (e)(2), consisting of the following language: "When it becomes necessary for an injured worker to travel in order to obtain appropriate and necessary medical care for a compensable injury, reimbursement for travel expenses is governed by sec.134.6 of this title (relating to Travel Expenses)."; and a new subparagraph (R) was added to (e)(2) , consisting of a CPT code disclaimer, stating that "The CPT codes used in the current Medical Fee Guideline should be used. The CPT codes listed in this subparagraph should not be used until they are adopted into a current Medical Fee Guideline." Changes were made to (g)(2), (3), and (4) to more closely conform them to the tables in the rule. Changes made for clarification purposes to (g)(2), Primary Level of Care, are as follows: the following language was added to the first sentence: "however, the injured worker in this level of care may also be an early postoperative patient or may be experiencing an acute exacerbation of his/her chronic back pain"; the last sentence in the paragraph was deleted: "This level of care generally occurs in the first eight weeks post injury but can recur with and acute exacerbation of symptoms or postoperatively."; and the following three sentences were added to the end of the paragraph: "Little or no deconditioning has occurred due to the injury, immobilization, or decreased activity. The goal for this level of care is symptom control to facilitate rapid recovery and return to work before deconditioning or psychosocial barriers occur. The usual duration for this level of care is eight weeks." In (g)(3), Secondary Level of Care, the first sentence, "This level of care is generally considered to be appropriate for injured workers demonstrating early deconditioning." has been rewritten as follows: "This level of care is the first stage of rehabilitation for those injured workers who have not returned to productivity through the normal healing process." The following language was added after the first sentence: "It is designed to facilitate return to productivity before the onset of chronic disability. It is individualized, time limited and of limited intensity. The injured worker has a history of a limited- to-good response to early primary treatment with persistent symptoms limiting activities of daily living. The objective physical examination demonstrates findings suggestive of early deconditioning including loss of motion and/or strength with limitation of activities of daily living. Evidence of mental health or psychosocial barriers may be present which impede the injured worker's clinical progress." The next two sentences were deleted: "This level of care can also be used to prevent the development of physical deconditioning or psychosocial barriers which may prevent an early return to work. This level of care generally occurs within two months of injury but may occur at a later time if there was a delay in the initial treatment." The usual duration for this level of care was changed from four weeks to eight weeks; and the following two sentences were added at the end of the paragraph: "In addition to the normative duration listed, an additional two weeks is added to the secondary level of care for less intensive care if necessary at the termination of the tertiary level of care. Documentation of necessity must be included with the request for the additional two weeks." Changes to (g)(4), Tertiary Level of Care, are as follows: the words "generally considered to be appropriate for injured workers who are unresponsive to the earlier levels of care" were deleted from the first full sentence of the paragraph; the second and third sentences, as follows, were deleted: "The programs provided at this level are considered to be of greater intensity than the preceding levels of care. An interdisciplinary approach to care is often utilized at this level." Next, the following language was added: "There is a documented history of persistent failure to respond to nonoperative or operative treatment which surpasses the usual healing period of four to six months post- injury or post-surgery or special cases with severe mental health issues lasting more than two months without response to primary or secondary treatment. Psychosocial issues such as substance abuse, affective disorders, and other psychological disorders may be present. There is a documented inhibition of physical functioning evidenced by pain sensitivity, and nonorganic signs such as fear which produces a physical inhibition or limited response to reactivation treatment. This level of care may also be indicated for the injured worker whose physical capacity to work still does not meet the job requirements for heavy physical labor after adequate treatment, thereby causing an inability to return to full duty. This situation would be evidenced by an excessive transitional period of light duty or significant episodes of lost work time due to the need for continued medical treatment. This level of care is also indicated for those injured workers who cannot tolerate either primary or secondary levels of care." The next to the last sentence of the paragraph, " The level of care generally occurs several months after the injury has occurred.", was deleted; and, in the last sentence of the paragraph, the usual duration for this level of care was changed from four to six weeks. Revisions for clarification purposes to Table II, Secondary Level of Care, include: the addition of "Interdisciplinary Programs, Chronic Pain Management, Work Hardening, and Outpatient Medical Rehabilitation" and the deletion of "Return to Work Programs" under the Types of Intervention category; the revision of the first sentence in the Return to Work Issues category, as follows, "The moderate level of severity is appropriate for a patient medically expected to return to work in less than six months, either with a full release or at minimally modified duty expected to last three months or less."; in the Failure to Respond category, the last sentence, as follows, was deleted: "Because secondary treatment requires the active cooperation of the injured worker, documented refusal to comply with the treatment recommendations may result in a determination that the injured worker has reached Maximum Medical Improvement (MMI)". Revisions for clarification purposes to Table III, Tertiary Care are as follows: in the Clinical or Behavioral Indicators category, the reference in (6) to Section 7 of the Mental Health Treatment Guideline has been revised to the correct Texas Register rule format reference of subsection (i); under the Interdisciplinary Programs heading of the Types of Intervention category, the addition of "Work Hardening" and "Outpatient Medical Rehabilitation", and deleted "Return to Work Programs"; and in the Failure to Respond category, the last sentence, as follows, was deleted: "Because secondary treatment requires the active cooperation of the injured worker, documented refusal to comply with the treatment recommendations may result in a determination that the injured worker has reached Maximum Medical Improvement (MMI)." Other revisions to the proposed rule for clarification are as follows: in Chart 4, the Peri-Operative Treatment Duration, under the Asymptomatic Pre-Existing Conditions category, "History of Smoking"; in the Lumbar Section of Charts 5A,5B, and 5C, CPT Code 20975 was added; the following language was inserted in (e)(2)(D), becoming new subparagraph (D): "Although preoperative educational programs and chronic pain management programs are not specifically outlined, the intent of this guideline is not to eliminate or prohibit their use. When deemed medically necessary, these programs may be considered appropriate types of intervention to be utilized."; and in Table I, Primary Level of Care, under Types of Intervention/Injections category, the word "therapeutic" was inserted before "facet injections". The commission recognizes the importance of input from a wide variety of sources (including employees, employers, health care providers and insurance carriers) that went into the drafting of this guideline. This input was crucial in ensuring a broad-based rule that establishes parameters for spine treatment, but does not mandate or proscribe any particular treatments. The commission recognizes that this rule is the subject of great public interest, and has sought to give thorough consideration and response to all comments received, including several comments received after the 30-day comment period and after the public hearings. The commission carefully and fully analyzed all the facts presented and the statutory objectives in formulating this guideline. In accordance with these statutory objectives and commission policy, the guideline balances the need for cost control and review with the need for access to quality medical care by establishing typical courses of treatment, but allowing treatment outside the set parameters with additional documentation of the need for the treatment. As a result, spine treatment will be scrutinized and reviewed, but all reasonable and necessary treatment will be provided. This is in accord with statutory objectives as well as commission policy and the facts before the commission. As required by the Government Code, sec.2001.033(1), the commission's reasoned justification is set out in this preamble, which discusses the reasons why the rule is necessary, the factual, policy, and legal bases for the rule, a summary of comments received, names of interested groups or associations that commented and whether they are for or against adoption of the rule; and the reasons why the agency disagrees with the comments, submissions, and proposals. This guideline is adopted to comply with a statutory mandate that the commission effect cost containment, as well as to fulfill the directives in the Texas Labor Code, sec.413.011 and sec.413.013 that the commission establish guidelines for medical policies relating to necessary treatments for injuries that ensure the quality of medical care and achieve effective medical cost control (sec.413.011); and programs for prospective, concurrent, and retrospective review of the necessity of treatments administered sec.(413.013). The guideline has been designed to achieve the following statutory and policy objectives: 1. to ensure quality health care to the injured workers of Texas; 2. to achieve effective medical cost control; and 3. to establish a program for prospective, concurrent, and retrospective review of the necessity of treatments. The guideline achieves these objectives by: 1. assisting all parties with regard to the appropriate treatment and management of disorders of the spine in workers' compensation healthcare; 2. establishing a guideline against which aspects of care can be compared; 3. identifying clinically acceptable courses of treatment for spine disorders; 4. establishing documentation standards which support the appropriateness of the level of service for assessment/evaluation and on-going treatment; 5. providing a mechanism for prospective, concurrent, retrospective review to ensure efficient and effective health care utilization; and 6. establishing treatment parameters based on clinical indicators to determine the appropriate treatment at different levels of healing. Back injuries comprise the largest group of injuries in the workers' compensation system. The most costly category of healthcare in the workers' compensation system is treatment for back injuries. Back injuries also account for the greatest loss of employee time from work. The Spine Treatment Guideline was developed to address this problem, as well as the issue of conservative and surgical treatment for spinal injuries. The guideline, through established criteria, documentation requirements, and timeframes, provides a basis for review of these treatments and services as required by statute to ensure quality medical care, cost control, and review of necessity of treatments. It also requires additional documentation/justification for treatment outside the guideline parameters. The Medical Review Division, in conjunction with the Medical Advisory Committee (MAC), and a broad representation from the medical community have worked together to develop the Spine Treatment Guideline. By statute, the MAC is to advise the division in developing and administering the medical policies, fee guidelines, and utilization guidelines established under the Texas Labor Code, sec.413.011. The MAC advises the commission or professional organization in the review and revision of medical policies and fee guidelines required under the Texas Labor Code, sec.413.012. The MAC is composed of members from the following fields, appointed by the commission: public health care facility, private health care facility, a doctor of medicine, doctor of osteopathic medicine, a chiropractor, a dentist, a physical therapist, a pharmacist, a podiatrist, an occupational therapist, a medical equipment supplier, a registered nurse, a representative of employers, a representative of employees, and two representatives of the general public. The Spine Treatment Guideline has taken over three years to develop. During 1992 and the first half of 1993, two workgroups developed, in the coordination with Texas Workers' Compensation Commission staff, a document to present to the Medical Advisory Committee (MAC). The workgroups comprised of only medical doctors and doctors of osteopath, divided between surgical specialties of the spine and specialists in conservative care of the spine. The initial document presented to the MAC was titled "Draft #5". The chairpersons of the two workgroups, Tom Mayer, M.D. and David Selby, M.D., presented the document and discussed its contents in September of 1993. The document was accepted by the MAC as a document to review. Because the document did not have input from other health care providers besides medical doctors and doctors of osteopaths, the MAC formed a subcommittee of MAC members comprised of a physical therapist, an occupational therapist, a chiropractor, a medical doctor and an osteopath. Since the medical doctor on the MAC is a surgeon, it was agreed that there would be a rehabilitation specialist, that had worked on the original conservative workgroup, to be a liaison between this subcommittee and the original workgroup. During the reviewing and editing of the document this liaison gave the original workgroup's chairperson a copy of new drafts of the document. As the subcommittee worked on the document,subsequent drafts were presented at MAC meetings during the fall of 1993. In the spring of 1994, Draft #8 of the Spine Treatment Guideline was recommended by the MAC to be submitted to the commissioners. It was proposed for publication with staff changes initially in May of 1994. After that comment period, because of editorial changes, it was decided to repropose the document in September of 1994. Because of possible misinterpretation of comments during the public hearing in January, 1995, the MAC discussed at their meeting the same month, the draft that they had recommended to be presented to the Commissioners. It was by consensus that the MAC members stated that it had been Draft #8 that had been recommended by the committee. The decision as to which treatments would go into the guideline, and the frequency and duration of those treatments was based on consideration of all statutory factors (discussed in the following paragraphs of this preamble), the input of the participants regarding treatments that are commonly used and medically accepted, recognized research studies, and consideration of all comments on the proposed rule. The research studies used as a reference and factual basis by the work group are reflected in the bibliography contained in the guideline. The knowledge, clinical expertise and qualifications of the work group members and the agency board and staff also served as the basis for the development and drafting of the guideline. The expertise was used to establish typical courses of intervention and to set documentation standards. The clinical and diagnostic treatment guidelines contained in this new rule have been developed in conjunction with health care providers (as described above) and other parties in the workers' compensation system. The development process involved a national search of state agencies administering workers' compensation programs, which revealed that only a few states had developed treatment guidelines. Research revealed an algorithmic approach to be the most understandable format for the guideline. A survey of the successful guidelines developed in the private sector (listed in the bibliography) identified that involvement from health care provider work groups achieves the best outcome regarding clinical policy development. The Spine Treatment Guideline clarifies those services that are reasonable and necessary for operative and nonoperative care to the spine for the injured workers of Texas. The guideline is not to be used as a fixed treatment protocol, but rather identifies a normal course of treatment, and reflects typical courses of intervention. It is anticipated that there will be injured workers who will require less or more treatment than the average. It is acknowledged that in atypical cases, treatment falling outside this guideline will occasionally be necessary. However, those cases that exceed the guideline level of treatment will be subject to more careful scrutiny and review and will require documentation of the special circumstances that justify the treatment. This guideline should not be seen as prescribing the type and frequency or length of intervention. Treatment must be based on patient need and professional judgement. The rule is designed to function as a guideline and should not be used as the sole reason for denial of treatments and services. This guideline is to be used by health care providers as a tool to establish the required elements for all providers to initiate treatment. The insurance carrier should use this guideline to compare treatment prospectively, concurrently, and retrospectively with the predetermined elements contained in this guideline. The commission's primary mission in initiating and developing this guideline is to ensure appropriate parameters relating to necessary treatments for compensable injuries; to provide a tool for monitoring of the necessity of treatments administered; and to provide a tool to review typical healthcare treatment. Quality of medical care is ensured by reliance upon input from experts and recognized studies in the field of spine treatment, and establishment of acceptable courses of treatment and treatment parameters for specific spine injuries. The guideline ensures access to health care and that quality care will be available in each individual case by its ground rules that allow for treatment outside the stated parameters. Effective medical cost control is achieved by establishing parameters for eligibility and termination of treatment, by setting documentation standards which support the appropriateness of the treatment; by requiring additional documentation for treatment falling outside the guideline's parameter; and by providing that spine treatments are subject to the commission's separate rule requiring carrier preauthorization for certain treatments as a prerequisite to payment for the services. The guideline allows for prospective, concurrent, and retrospective treatment by: setting standards for eligibility and treatment and setting documentation standards. These standards are to be used by health care providers as a basis for prospective review of possible treatment. The guideline and the documentation requirements should also provide the health care provider with a means to justify treatments when questioned concurrently or retrospectively by an insurance carrier. The guideline and documentation also provide a starting point for carriers in conducting prospective, concurrent, or retrospective review of treatment. Finally, the Medical Review Division and the Compliance and Practices Division will also use the guideline and documentation as a tool for prospective, concurrent, and retrospective review of treatment, including use in conducting on-site audits of health care providers and insurance carriers. The guideline also promotes quality health care, injury specific treatment and appropriateness of care, by facilitating communication between all parties in order to achieve rapid recovery from the effects of an injury. This communication will also promote a timely return to modified or full duty work that takes into account the job demands and the functional capabilities of the injured worker. Written comments were received on the proposed new rule from: American Medical Electronics; Work Assessment Center, Inc.; The Center for Pain Medicine; Medtronic; HealthPlus Medical + Group; The Pain Clinic; Medical Center Anesthesia Associates, P.A.; Neurological Associates of Dallas; West Houston Doctor's Center; Healthsouth Dallas Rehabilitation Institute; Fort Worth Education and Research Foundation for Pain Management; Alamo Bone & Joint Clinic; Texas Medical Institute of Pain Specialists; the Texas Workers' Compensation Insurance Fund; Biofeedback Associates; NIX Health Care System; The Pain Management Centers of South Texas; The Center for Orthopedic Surgery; Pain & Health Management Center; Mid-Cities Headache & Pain Medicine Center; Texas Association of Business; Texas Osteopathic Medical Association; PRIDE; The University Center for Pain Medicine and Rehabilitation at Hermann; Texas Pain Institute; UT-MD Anderson Cancer Center and Hospital; Pain Care Center Pain Program; University of Texas Southwestern Medical Center at Dallas; Baylor Center for Pain Management; SPORTSMED Rehabilitation Center & Clinic; Texas Neurological Society; Medical Psychiatric Association; Business Insurance Consumers' Association; Texas Medical Association; The Health Industry Council; Center for Psychiatric Medicine; The Pain & Rehabilitation Institute; Active Back Rehabilitation Center, P.A.; Texas Institute of Pain Medicine, Inc.; Productive Institute of Dallas; National Pain Institute of Texas; EBI Medical Systems, Inc.; Health Benefit Management, Inc.; and 96 individuals. Representatives from the following associations and individuals gave testimony at the public hearing held on January 12, 1995: the American Insurance Association; the Texas Medical Association; Healthsouth Spine & Rehabilitation Center; American Medical Electronics, Inc; the Texas Chiropractic Association; the Texas Association of Business; Omega Rehabilitation Center; the Texas Workers' Compensation Insurance Fund; the Texas Osteopathic Medical Association; the Business Insurance Consumers' Association; and 24 individuals. Those commenters expressing overall support of the proposed rule are NIX Health Care System; the Pain Management Centers of South Texas; the Center for Pain Medicine; West Houston Doctors' Center; Medtronic; Healthplus Medical Group; Texas Pain Institute; American Medical Electronics; Medical Center Anesthesia Associates, P.A.; Veterans Affairs Medical Center; the Pain & Rehabilitation Institute; Pain Management Consultants, P.A.; Pain & Health Management Center; the Texas Workers' Compensation Insurance Fund; the American Insurance Association; and 19 individuals. Those commenters expressing overall opposition to the proposed rule are: Mid- Cities Headache & Pain Medicine Center; Active Back Rehabilitation Center, P.A.; the Center for Psychiatric Medicine; Texas Medical Institute of Pain Specialists; PRIDE; American Medical Electronics; Texas Back Institute; SPORTSMED Rehabilitation Center and Clinic; Texas Osteopathic Medical Association; Productive Rehabilitation Institute of Dallas for Ergonomics; and 17 individuals. Following is a summary of comments received and the agency's responses. The following comments were received regarding the application tables. COMMENT: In the Application Tables for Consulting and Referral Doctors, commenters recommended that diagnostic procedures should be listed as a function. RESPONSE: The commission disagrees. By definition, a consulting doctor cannot initiate either diagnostic or therapeutic services, and a referral doctor may initiate diagnostic or therapeutic services only with the consent of the treating doctor. COMMENT: Several commenters suggested that the phrase "Clear need for preauthorization documentation in evidence of record" be clarified in the Application Tables (B) Ongoing Treatment. RESPONSE: The commission agrees that it is not clear. This phrase has been deleted because it involves preauthorization. COMMENT:In the application table addressing Ongoing Treatment, the Insurance Carrier box, a suggestion was made to combine items 1 and 2 to read as follows:"Concurrent case management and bill review activities should address and focus on adherence to treatment plans, clinical progress, return to work issues, medical necessity, and the following: a. Injured worker compliance with treatment; b. Services provided consistent with treatment plan; c. Response to treatment; d. Improvement in injured workers' progress; e. Recommendations for changes in treatment in situations where there is no compliance, plateau, and/or there is minimal or no progress; and f. Achievement of goals, improvement sooner than treatment plan indicated." RESPONSE: The commission agrees. The guideline has been revised to include the recommended language. COMMENT: In the application table addressing Ongoing Treatment, Insurance Carrier Column, it was suggested to use the following language: "Within 24 hours, insurance carrier responds verbally and within three days, insurance carrier responds with written report. Denials require clear explanation of reason." RESPONSE: The commission disagrees with the suggested revision. References to the specific contents of the preauthorization rule have been deleted from the guideline. A sentence has been inserted in the guideline which states: "Preauthorization of any treatments or services will be as required in the commission's preauthorization rule." COMMENT: One commenter suggested that the title "Application Tables" be changed to "Treatment Tables". RESPONSE: The commission disagrees. The Application Tables apply not only to treatment but also to evaluation/assessment and documentation requirements. COMMENT: Concern was expressed by the commenter that the application tables do not specifically outline the process by which the insurance carrier and the health care provider coordinate the provision of care to the injured worker. The commenter suggested that this process be specifically delineated in this document to provide a uniform approach for the coordination of care. RESPONSE: The commission disagrees. This process is outlined in the Application Table, subsection (d)(2)(A), (B), and (C). Coordination is accomplished through communication in the form of timely reporting, documentation of care, and review of the care provided. COMMENT: One commenter suggested that diagnostic procedures be added to the functions of the consulting and referral doctors in the Assessment Tables. RESPONSE: The commission disagrees. The consulting and referral doctors should be performing diagnostic procedures only with the knowledge and consent of the treating doctor. Adding these procedures to the consulting and referral doctor areas would imply that these doctors could bypass the treating doctor in developing the treatment plan for the injured worker. COMMENT: Concern was expressed that the Spine Treatment Guideline (STG) does not specifically outline the insurance carrier's medical audit process. A suggestion was made to either add that section or to reword that section to state: "This guideline serves as an additional tool to assist insurance carriers with the review of the medical audit process." RESPONSE: The commission agrees with the suggested revision. The guideline has been revised in subsection (d)(1)(B)(iii) to read as follows: "This guideline serves as a tool to assist the insurance carriers in the medical audit process." COMMENT: Several commenters suggested that, in subsection (d)(1)(E), a statement be included regarding any action that may be allowed against the injured worker if non-compliance with the treatment protocols is demonstrated, similar to the statement addressing injured worker non-compliance in tertiary care. RESPONSE: The commission disagrees. References combining patient noncompliance with a resultant determination of Maximum Medical Improvement were deleted from the treatment guideline. This issue will be addressed in proposed amendments to other commission rules. COMMENT: Concern was expressed by a commenter that there is no place in the guideline that delineates a mechanism for the various reviews mentioned in the statement, "The guideline has been designed to achieve the following goals: 5) Provide a mechanism of prospective, concurrent, retrospective review for efficient and effective health care utilization." Each review mentioned should have the mechanism of review presented to enable the physician and the injured worker to better understand the reasoning behind such reviews; the integral parts of data to be reviewed, and the outcome of such reviews, and the possible effects on the injured worker of such outcome decision. Providing a mechanism would allow for a more standard review. RESPONSE: The commission disagrees. The Application Tables provide a basic outline of the insurance carrier's responsibilities regarding prospective, concurrent and retrospective review of the injured worker's plan of care. COMMENT: One commenter was concerned that the guideline do not outline the responsibilities of the employer to interact with the health care provider and injured worker to ensure a rapid return to work, including a return to light duty or modified work. RESPONSE: The commission agrees. A new subparagraph regarding employer responsibilities has been added to subsection (d)(1) which is titled "(F) Employer" and which states: "It is the responsibility of the employer to report the compensable injury in a timely fashion to ensure that there is no delay in the treatment of the compensable injury. It is also the responsibility of the employer to work with the insurance carrier and health care providers to ensure that the injured worker is afforded the opportunity to return to work in either a modified or full employment capacity as rapidly as possible within the medical limitations of his/her injury." COMMENT: A commenter suggested that subsection (d)(1)(D), regarding the consulting or peer review health care provider, be expanded to require the following: a. the doctor selected by the Medical Review Division for peer review should be certified as a peer review in accordance with his/her respective practice Act; b. the doctor selected by the Medical Review Division for peer review should not derive more than 5% of his/her total income from performing this type of service for insurance carriers or audit companies; and c. the doctor selected by the Medical Review Division for peer review opinions must have equivalent training and experience as the provider regarding the disputed services and/or procedures. RESPONSE: The commission disagrees that the qualifications of a peer reviewer need to be outlined in a treatment guideline. The purpose of the treatment guideline is to outline services that are considered reasonable and necessary for both operative and nonoperative care to the spine for the injured worker. The delineation of any qualifications for peer reviewers is a separate issue and needs to be addressed in a separate rule. The following comments were received regarding ground rules. COMMENT: A suggestion was made by a commenter to delete any reference to specific time frames when referencing the preauthorization rule due to the proposed changes in that rule. RESPONSE: The commission agrees. References to the specific contents of the preauthorization rule have been deleted from the Guideline. A sentence has been inserted in the guideline as Ground Rule (O) which states: "Preauthorization of any treatments or services will be as required in the commission's preauthorization rule." COMMENT: Several commenters suggested that, in the surgical algorithms, a CPT code (20975) for the operative placement of the SpF spinal fusion implant be included. A suggestion was also made to include a CPT code (20974) in charts 5A, 5B, and 5C. RESPONSE: The commission agrees with the inclusion of code 20975 in the guideline. The CPT code 20975 has been added to Chart 5A, 5B, and 5C in the algorithms, and Ground Rule (M) was rewritten as follows: "Indications for bone growth stimulators (internal and external) (CPT codes 20974 and 20975) include: a. Revision spinal fusion b. History of spinal fusion or delayed union at different levels c. Multiple level spinal fusion d. Use of allograft e. Spondylolisthesis greater than grade two f. Nonassociated high risk problems such as metabolic bone disease, smoking, diabetes, and obesity." Code 20974 was not added to the charts because it is not listed as an invasive procedure. COMMENT: Two commenters suggested a re-write of the section concerning early CT scans to read as follows: "Documentation of significant neurological deficit, clinical findings, or recommendations of a consulting doctor, may support . . .". Additional commenters noted that intractable pain should be included as an indicator for the acutely injured worker to receive such diagnostic studies as CT scans and MRIs. RESPONSE: The commission disagrees. The recommendations regarding the early use of CT scans and MRIs contained in the guideline reflect the research presented to the commission by the work group and MAC. COMMENT: Concern was expressed regarding the proposal that access to CT scans and MRI studies be limited to those injured workers who displayed focal neurological deficits. It was felt that these tests should also be made available to those injured workers who failed a brief trial of conservative treatment during the initial six weeks after injury. RESPONSE: The commission disagrees. The recommendations regarding the early use of CT scans and MRIs contained in the guideline reflect the research presented to the staff by the work group and MAC. COMMENT: Commenters expressed multiple concerns regarding the description of the mental health evaluation and treatment as it applies to the work hardening program. The comments were as follows: a. The guideline did not provide specific information regarding the provision of individual mental health treatment during the course of a work hardening program, although references were made to an initial evaluation and group counseling. b. The clarification of what psychological services should and should not be contained within work hardening should be addressed with the additional sentence: "psychological services other than those noted above are not considered part of work hardening." c. "Language specifying the focus of this (work hardening) evaluation" was not clearly outlined in the guideline. d. The guideline did not provide a clear statement indicating that "all other individual mental health services are separate from work hardening and require preauthorization." e. A suggestion was made to keep references to the Mental Health Treatment Guideline (MHTG) intact in the Spine Treatment Guideline. f. In addition, the following revision was suggested regarding reimbursement issues: "Group counseling should be billed at the global fee rate for work hardening. All other psychological services should be billed separate from work hardening at the rate prescribed in the Fee Guidelines." RESPONSE: The commission agrees with the suggestion to clarify whether individual mental health treatment is included in the work hardening program. This section has now been revised to include the following sentence: "Individual therapy (i.e., one-to-one therapy) with a Qualified Mental Health Provider is not considered to be part of the Work Hardening program." This answers (a) and (b) of the comments. The commission disagrees with the remaining suggestions for the following reasons: a. The focus of any mental health evaluation, including that performed for a work hardening program, is contained within the Mental Health Treatment Guideline. b. Preauthorization is not addressed in this guideline. The guideline refers the health care provider to the preauthorization rule for clarification of the need for preauthorization of services rendered to the injured worker. c. References to the Mental Health Treatment Guideline are present in subsection (g), Tables II and III. d. Issues specifically addressing reimbursement are not a component of this guideline. That issue is within the domain of the Medical Fee Guideline. COMMENT: A recommendation was made that the three hour mental health evaluation (without preauthorization) have a time limit, such that, after a specified period of time, additional evaluation(s) would be allowed without the need for preauthorization. The time interval suggested was six months. One commenter suggested the following revision: "If three hours of evaluation services have been provided during the previous six month period, then preauthorization is required for the additional services." RESPONSE: The commission disagrees. The concern expressed by the commenters is addressed in the Mental Health Treatment Guideline, and the recommendations, as outlined in that guideline, should be followed regarding the evaluation and treatment of any associated mental health disorder. COMMENT: Concern was expressed that, in revision, the section regarding how mental health services were to be billed was deleted from the guideline. RESPONSE: The commission disagrees that billing should be addressed in this treatment guideline. The guideline does not address the issue of reimbursement. The purpose of a treatment guideline is to address the diagnosis, treatment, and rehabilitation of the injured worker. Reimbursement of the services described in the treatment guideline are discussed in detail in the Medical Fee Guideline. COMMENT: Concern was expressed that the allowance of a three hour mental health evaluation, without preauthorization, prior to the initiation of a work hardening program would lead to an abuse/overuse of this service. RESPONSE: The commission agrees with the concerns expressed by the commenters. Subsection (e)(2)(I) has been rewritten and issues relating to preauthorization have been deleted because it is addressed in a separate rule. COMMENT: A suggestion was made to re-write subsection (e)(2)(I) as follows: "Work hardening programs may include a psychotherapy/behavioral medicine/pain management group as part of the recovery process, usually not individual therapy. This group must be conducted by a qualified mental health provider. Separate preauthorization for this type of therapy is not required. However, in an attempt to determine the injured workers' readiness for work hardening, a mental health evaluation provided one-to-one by a qualified mental health provider, may be performed prior to admission into the program. Referral for this evaluation must come from the treating doctor." RESPONSE: The commission agrees with the need to clarify subsection (e)(2) (I). The rewritten paragraph is consistent with the Medical Fee Guideline and includes the issues of individual therapy, Qualified Mental Health Provider, and the statement regarding referral. In addition to the commenters' changes, references to preauthorization have been deleted because it is addressed in a separate rule. This paragraph has been revised to read: "An initial mental health evaluation to determine the injured worker's readiness for the Work Hardening program may be performed prior to entrance into the program. This evaluation is not considered part of the Work Hardening program. Group therapy, provided by a Qualified Mental Health Provider, is considered to be part of the Work Hardening program. Individual therapy (i.e., one-to-one therapy with a Qualified Mental Health Provider) is not considered to be part of the Work Hardening program. Referral for this evaluation must come from the treating doctor." COMMENT: Concern was expressed that subsection (e)(2)(K), as currently written, would lead to overutilization of the system. RESPONSE: The commission disagrees. In that section, the guideline states that documentation should be provided which outlines the clinical progress of the injured worker and shows evidence of the doctor's supervision. In subsection (e)(2)(A)(iii) and (iv) and in subsection (g)(5), the guideline states that the treatment of the injured worker should be provided in the least intensive setting and should be cost effective. COMMENT: Concern was expressed that the consensus document presented by the combined work group and the MAC did not include "cumulative duration": the intent of the described document did not intend to have cumulative durations but to have specific durations of eight, twelve, and sixteen weeks respectively for primary, secondary, and tertiary care. RESPONSE: The commission disagrees. Draft Eight of this guideline, which was reviewed by the MAC prior to its presentation to the commission, did contain the word "cumulative". COMMENT: A suggestion was made to specifically mention back school and preoperative education in the ground rules addressing the need for patient education. A suggestion was also made to include patient education as part of any pain management program. RESPONSE: The commission agrees that patient education needs to be clarified. Some of the components of a patient education program are listed in the tables outlining the levels of care. The commission recommends the formation of a work group at a later date to address both criteria for the preoperative education program and pain management programs. A ground rule has been added to the guideline which states: "Although preoperative educational programs and chronic pain management programs are not specifically outlined, the intent of this guideline is not to eliminate or prohibit their use. When deemed medically necessary, these programs may be considered appropriate types of intervention to be utilized." In addition, the commission recommends the formation of a work group at a later date to address both criteria for the preoperative education program and pain management programs. COMMENT: Concern was expressed regarding the requirements present in the guideline requiring the treating doctor and other involved health care providers to inform the injured worker differentiating between treatment that is causally related to the injury and treatment that is not causally related to the compensable injury. The concerns were specifically addressed regarding informing the injured worker of his probable responsibility for payment for those services not causally related to the compensable injury. A form was suggested by the commenter, similar to forms used by Medicare and Medicaid, that should be signed by the injured worker upon receiving this information, thereby documenting his comprehension of payment responsibility for treatment not related to the compensable injury. RESPONSE: The commission disagrees. The requirements outlined in the guideline regarding the need for the treating doctor to separate those symptoms and treatments causally related to the compensable injury from those unrelated to the compensable injury is not a new requirement. This responsibility has been present since the enactment of this law. This section is simply reiterating the need to separately treat and charge for both compensable and noncompensable signs and symptoms appropriately. The required development and use of an additional form would not speed the process and would only increase the amount of paperwork required for each injury. COMMENT: Several commenters suggested that subsection (e)(4) include complications of treatment with examples. RESPONSE: The commission disagrees. The section referred to by the commenter refers to documentation requirements for unrelated or intercurrent illness. Causal relation to a given injury needs to be determined by the treating doctor and may vary with each case. COMMENT: Concern was expressed that, in subsection (e)(2)(F), allowing the injured worker to move freely between the levels of care, dependent upon the clinical indicators, would lead to overutilization and abuse of the system of care. RESPONSE: The commission disagrees. In that subsection (e)(2)(K), the guideline states that documentation should be provided which outlines the clinical progress of the injured worker and shows evidence of the doctor's supervision. In subsection (e)(2)(A)(iii) and (iv) and in subsection (g)(5), the guideline states that the treatment of the injured worker should be provided in the least intensive setting and be cost effective. COMMENT: A suggestion was made to substitute "will" for "should" in several places in the guideline: a. Subsection (e)(2)(D) b. Subsection (e)(2)(K) c. Subsection (e)(3)(B) (in addition "may" should also be changed to will" in this section) d. Subsection (e)(3)(C) e. Subsection (e)(4) An additional suggestion was made to substitute "shall" for "should" in several places in the guideline. RESPONSE: The commission disagrees. The word "should" denotes an expectation based upon a standard the commission wishes to occur. Since the intent of the statement is to set a standard of expectation, the wording is correct. COMMENT: Several commenters expressed concern that the guideline does not address external bone growth stimulators as reasonable and necessary. RESPONSE: The commission agrees. Upon review of the document and the research provided by the commenters, a revision was made to the guideline to include external bone growth stimulators. The revision reads as follows: "Indications for bone growth stimulators (internal and external) (CPT codes 20974 and 20975) include: a. Revision spinal fusion b. History of spinal fusion or delayed union at different levels c. Multiple level spinal fusion d. Use of allograft e. Spondylolisthesis greater than grade two f. Nonassociated high risk problems such as metabolic bone disease, smoking, diabetes, and obesity." COMMENT: Concern was expressed that it is unclear which "progressive neurological conditions" would result from a work-related injury. In order to avoid the improper classification of progressive neurological conditions as work-related, a suggestion was made to provide examples of such conditions. RESPONSE: The commission disagrees. The phrase "progressive neurologic deficit" is directly obtained from the spinal surgery rule which states that a medical emergency may include a "severe or rapidly progressive neurological deficit." The phrase "progressive neurological condition" refers to the neurological symptoms displayed by the injured worker as a result of the spinal injury. The need for examples of these two phrases is unnecessary within the context of the rule. COMMENT: Concern was expressed regarding the statement "all tertiary, inter/multi-disciplinary programs are subject to pre-authorization." The commenter wanted clarification regarding what specific programs would require preauthorization under this guideline. Commenter also noted that the reference to inter/multidisciplinary programs is different from the reference in proposed preauthorization rule which refers to the programs as multidisciplinary programs and requires preauthorization only after four weeks of therapy. RESPONSE: The commission agrees. References to the specific contents of the preauthorization rule have been deleted from the Guideline. A sentence has been inserted in the guideline which states: "Preauthorization of any treatments or services will be as required in the commission's preauthorization rule." COMMENT: A suggestion was made to re-write subsection (e)(2)(J) as follows: This guideline does not preclude the need for compliance with other rules with the exception of sec.134.600 of this title (relating to Procedure for Requesting Pre-Authorization of Specific Treatments and Services), or its successor. This guideline does preclude compliance with sec.134.600 or its successor when the guideline calls for specific treatment and services. The only time that sec.134.600 or its successor should come into play is when the proposed treatment or service falls outside those parameters as set forth in the spinal treatment guideline." RESPONSE: The commission disagrees that the guideline should supersede the preauthorization rule. References to the specific contents of the preauthorization rule have been deleted from the Guideline. A sentence has been inserted in the guideline which states: "Preauthorization of any treatments or services will be as required in the commission's preauthorization rule." The following comments were received regarding diagnostic procedures. COMMENT: Concern was expressed that the time frames outlined in the section on diagnostic procedures have been altered from those agreed upon in Draft 7 of the Spine Treatment Guideline. RESPONSE: The commission disagrees. The addition of the zero -six week time period for the diagnostic procedures was a clarification of the ground rules concerning CT scans and MRIs. The recommendations regarding the early use of CT scans and MRIs reflect the research presented to the commission by the workgroup and the MAC. COMMENT: A suggestion was made that the terms "static x-ray", "motion study", and "postural study" be listed under plain x-ray in the diagnostic interventions section. RESPONSE: The commission disagrees. The list of diagnostic procedures is directly from the North American Spine Society (NASS) and was recommended by both the work group and the MAC. COMMENT: A suggestion was made to add videofluoroscopy and computerized isometric/isokinetic testing to the diagnostic interventions section. RESPONSE: The commission disagrees. The list of diagnostic procedures was derived from NASS and was recommended by both the work group and the MAC. COMMENT: A suggestion was made that SEMGs and ultrasound also be added to the diagnostic interventions section. RESPONSE: The commission disagrees. The list of diagnostic procedures was derived from NASS and was recommended by both the work group and the MAC. COMMENT: A suggestion was made that CT scans, MRIs, diagnostic selective nerve root injection, and diagnostic facet injection, be added to the time period 0 to 6 weeks (subsection (h)(3)(A)). RESPONSE: The commission disagrees. The recommendation regarding the early use of CT scans and MRIs reflect the research presented to the commission by the workgroup and the MAC. The use of early facet injection is discouraged in the federal clinical guidelines on the care of low back pain. COMMENT: A suggestion was made to substitute "diagnostic interventions" for "treatment" in subsection (h)(3)(A) and (B). RESPONSE: The commission disagrees with the need for this revision. The phrases referred to by the commenter are not in the section cited. COMMENT: A suggestion was made to re-write subsection (f)(3)(D) to address the need for preauthorization of mental health evaluations after the first three hours. RESPONSE: The commission disagrees. References regarding preauthorization have been deleted from this guideline. Mental health evaluations are addressed in the Mental Health Treatment Guideline (MHTG). COMMENT: A suggestion was made that the last sentence of subsection (f)(3) (D) which states, "a mental health evaluation may be performed at any time in the injured worker's recovery if it is deemed necessary to his/her recover" be struck completely, or the language be replaced with language from the Mental Health Treatment Guideline which is more consistent with the intent of the Act and good clinical practice. It was expressed that this language defines medical necessity more narrowly than the Mental Health Treatment Guideline. RESPONSE: The commission agrees. This sentence has been struck from the guideline. COMMENT: A suggestion was made to eliminate plain x-rays in the first six weeks, except for those cases where there are documented symptoms of a tumor or an infection. RESPONSE: The commission disagrees. The list of diagnostic procedures was derived from NASS and was recommended by both the work group and the MAC. COMMENT: Information was provided regarding the appropriate use of electrodiagnostic material, specifically surface EMGs, needle EMGs, and nerve conduction studies. The comment is more informative rather than a true comment on the Spine Treatment Guideline. The following comments were received regarding levels of nonoperative care. COMMENT: Concern was expressed regarding the duration for primary care of zero to eight weeks. It was felt that this duration does not meet minimal standards for helping the more severely injured workers safely back to work. A recommendation was made by a commenter that a more appropriate time frame for primary care was zero to 12 weeks. RESPONSE: The commission disagrees. Although there may be some instances where the need for primary care extends beyond the eight week period in the guideline, a research of the literature has shown that approximately 75 percent of all injured workers sustaining an occupational back injury return to work within four weeks of the date of injury. An additional nine percent of those injured workers return to work within eight weeks of the date of injury. In addition, upon review of a videotaped presentation of the guideline by Tom Mayer, M.D., (chairman of the original work group) to the Medical Advisory Committee (MAC) in September, 1993, the duration in patient contact hours for the primary level of care was set at 50 hours of treatment. This amount of time, when distributed among the services normally provided during the primary level of care, including office visits, physical medicine, and diagnostic studies, totals to approximately eight weeks of care. COMMENT: Concern was expressed regarding the proposed duration for secondary care of zero to four weeks. The reasons for this expressed concern are as follows: a. It is felt that this duration does not meet minimal standards for helping the more severely injured workers safely back to work. b. It was felt that this duration is below minimum community standards. c. It was felt that a maximum of four weeks for secondary level of care is an inadequate period of time for most patients who require reconditioning, strengthening and return to work programs. d. Failure to return to work or achieve resolution of symptoms within the four week period may encourage unnecessary testing and/or surgery. Recommendations were made by commenters regarding more appropriate time frames for secondary care: a. A duration of four to 12 weeks for secondary care. b. A duration of zero to six weeks for secondary care. RESPONSE: The commission agrees. Upon review of the literature, the commission determined that four weeks was not a reasonable period of time for the secondary level of care. Additional time is needed to treat the injured worker who is deconditioned and who may require services ranging from physical medicine to mental health evaluation and treatment. In addition, upon review of a videotaped presentation of the guideline by Tom Mayer, M.D., (chairman of the original work group), to the MAC in September, 1993, the duration in patient contact hours for the secondary level of care was set at 150 hours of treatment. This amount of time, when distributed among the services normally provided during the secondary level of care, including office visits, physical medicine, return to work programs lasting four-eight hours daily, and diagnostic studies, amounts to approximately eight weeks of care. Therefore, this level of care has been extended to eight weeks in the guideline. COMMENT: Concern was expressed regarding the duration for tertiary care of zero to four weeks. The reasons for this expressed concern are as follows: a. It was felt that this duration does not meet minimal standards for helping the more severely injured workers safely back to work. b. It was felt that this duration is below minimum community standards. c. It was felt that patients requiring tertiary care cannot participate in active therapy or return to work programs until they have completed a tertiary program. These patients require additional supervision and additional treatment beyond that provided in a secondary program. d. The guideline stated several times that tertiary treatment is the last remaining option before MMI. Allowing only four weeks of tertiary care will prevent optimal outcomes which will result in decreased return to work options, increased risk of re-injury and added medical costs. e. It was felt that an additional two weeks would make the duration of treatment consistent with that for a multidisciplinary work conditioning program. f. The guideline durations for all levels of care would indicate that a patient entering the system at the primary level of care would complete all levels of care within four months. This would force the injured worker into the system early. Research on return to work fully supports treatment and return to work in six months. Injured workers who remain off work for greater than six months are less likely to return to work. Recommendations were made by commenters regarding more appropriate time frames for tertiary care: a. A duration of six to 16 weeks. b. A duration of zero to 12 weeks. c. A duration of zero to six weeks. RESPONSE: The commission agrees. Upon review of the literature, the commission determined that four weeks was not a reasonable period of time for the tertiary level of care. Additional time is needed to treat the injured worker who is deconditioned and who may require intensive services ranging from physical medicine to mental health evaluation and treatment. In addition, upon review of a videotaped presentation of the guideline by Tom Mayer, M.D., (chairman of the original work group), to the MAC in September, 1993, the duration in patient contact hours for the tertiary level of care was set at 250 hours of treatment. Since most tertiary level of care programs are intensive, requiring eight to ten hours per day, five days per week, the number of weeks provided, using the recommended patient contact hours, would amount to five to six weeks. Therefore, this level of care has been extended to six weeks in the guideline. In addition, after discussion with medical experts, the guideline recommends two weeks of less intensive secondary level of care after the tertiary level if documentation warrants the need. This allows for the injured worker to continue the reconditioning without the need for the intensive tertiary program. The number of weeks of total care coincides with the recommendations of the Colorado Treatment Guidelines. COMMENT: General support was given for the duration of time being a total of 16 weeks or four months. The combined work group and MAC rewrote the guideline to reflect the following durations: Primary-less than eight weeks; Secondary-less than 12 weeks; and Tertiary-less than 16 weeks, with a cumulative total of 16 weeks. This is ample time to provide quality care for a back injury due to the research showing that it is almost impossible to get a worker with a back injury to work after six months from injury onset. Additional time for more severe cases can be preauthorized. RESPONSE: The commission disagrees. Upon further review of the literature, including evidence provided by the commenters and a re-review of the videotapes addressing the guideline, the durations have been revised to allow eight weeks for the primary level of care, eight weeks for the secondary level of care, and six weeks for the tertiary level of care, totalling 22 weeks or approximately 5 1/2 months. In addition, to the normative durations listed in each section, an additional two weeks is added to the secondary level for less intensive care if necessary at the termination of the tertiary level of care. Documentation of necessity must be included with the request for the additional two weeks. COMMENT: Support was expressed regarding the times allotted for the secondary and tertiary levels of care. RESPONSE: The commission disagrees. Upon further review of the literature, including evidence provided by the commenters and a re-review of the videotapes addressing the guideline, the durations have been revised to allow eight weeks for the primary level of care, eight weeks for the secondary level of care, and six weeks for the tertiary level of care, totalling 22 weeks or approximately 5 1/2 months. In addition, to the normative durations listed in each section, an additional two weeks is added to the secondary level for less intensive care if necessary at the termination of the tertiary level of care. Documentation of necessity must be included with the request for the additional two weeks. COMMENT: Concern was expressed that the proposed Spine Treatment Guideline is recommending a reduction in reimbursement for tertiary care from its current level to the recommended reimbursement for work hardening ($35 per hour). A suggestion was made that reimbursement for tertiary care be established at $55 per hour. RESPONSE: The commission disagrees. The guideline does not address the issue of reimbursement. The purpose of a treatment guideline is to address the diagnosis, treatment, and rehabilitation of the injured worker. Reimbursement of the services described in the treatment guideline are discussed in detail in the Medical Fee Guideline. COMMENT: General concern was expressed regarding the content of the tertiary care program as proposed in the Spine Treatment Guideline. A general revision of this section was strongly suggested. RESPONSE: The commission disagrees. The guideline contains the definition of tertiary care as agreed upon by the members of the combined work group which contained health care providers from all professions and as delineated in Draft 8 from which the guideline was derived. COMMENT: Concern was expressed regarding the "deletion of major portions of text necessary to explain the principles of the STG to people likely to use it, including critical parts of Sections 6 and 7 (Phases of Nonoperative Care: Referral Criteria and Assessment/Evaluation)". Concern was expressed regarding the "removal of specific referral criteria for each of the three intervention phases", and that as a result, there appears to be no delineation between secondary and tertiary care in the Spine Treatment Guideline. The commenter also noted that the criteria to distinguish between secondary and tertiary care was "still missing the reference to the Mental Health Treatment Guideline Section VII." One of the commenters noted that the distinctions between phases of treatment and levels of care were not apparent in the guideline and recommended restoration of this section to the guideline. RESPONSE: The commission disagrees that any sections of the guideline were completely deleted. Upon review of the guideline and comparison with Draft 8, the information contained in Draft 8 of this document was contained in some form in the guideline. Much of the information referenced by the commenter was duplicated in the tables outlining the levels of care. The commission considered this duplication to be unnecessary. The revised descriptions of secondary and tertiary care, as outlined in subsection (g), including the tables, clearly differentiate the criteria for entry into each level of care and clearly outline the programs acceptable for both of the levels of care. This section does not outline phases of treatment but instead deals with the different levels of intensity of treatment required by the injured worker based on his/her presenting signs and symptoms. The references to the Mental Health Treatment Guideline are present in Tables II and III of subsection (g). The commission deleted the specific subsection for the MHTG since they were incorrect. COMMENT: A suggestion was made to re-write subsection (g)(4) to include the phrase "This level of care generally occurs several months after the injury has occurred." RESPONSE: The commission disagrees with the need to rewrite this section. The sentence proposed by the commenter is already present in the paragraph cited. COMMENT: A suggestion was made to state specifically in the tertiary level of care that the multidisciplinary program is the preferred approach. RESPONSE: The commission disagrees with the need to further state that multidisciplinary is the preferred approach. In Table III, Tertiary Level of Care, the description already states that "this is interdisciplinary, individualized and intensive treatment designed for injured workers already demonstrating physical and psychological changes consistent with chronic disability". COMMENT: Concern was expressed with subsection (g)(2)(C)(vii) which recommends observing the claimant's tolerance for sitting or standing as a variable for evaluating functional capacity. This observation is extremely subjective, and its value with regard to this test is unclear. In addition, the level of each claimant's cooperation can skew the results of other recommended indicators. RESPONSE: The commission disagrees. It is important for the evaluator to observe those actions which are quantitatively measurable and those which are qualitative or subjective in nature to obtain a complete picture of the injured worker's ability to function. Both types of observations can be skewed by the injured worker's ability or desire to cooperate. However, the significance lies in the contradictions which may or may not be present when comparing both sets of data. For instance, range of motion can be measured with an inclinometer or goniometer and is considered to be an objective measurement of the injured worker's ability to move freely. However, it may differ significantly from an observation of the injured worker freely bending over in a chair to tie his/her shoes. The reliability of the objective measurement can be readily determined by the injured worker's movements when he/she feels that he/she is unobserved. COMMENT: A commenter agreed with the statement in subsection (g)(3)(B)(iii) which states, "invalid or scientifically unjustifiable techniques shall not be reimbursed." , but suggested that it would be helpful if examples were given. RESPONSE: The commission disagrees. Examples of techniques that are now considered to be experimental in nature may not be appropriate even in one year. It is the responsibility of both the health care provider and the insurance carrier to maintain current knowledge of widely accepted treatment techniques and to be aware of those treatments which are considered to be experimental in the eyes of the treatment community. The following comments were received regarding the tables. COMMENT: Support was expressed regarding the primary level of care table which indicated only a limited period of bed rest and initiation of exercise starting two weeks post injury. RESPONSE: The commission agrees. COMMENT: A suggestion was made to revise Table I. Primary Level of Care to indicate that primary care involves all levels of severity. RESPONSE: The commission agrees that the primary level of care should be used when medically appropriate for any injury no matter the severity of the injury. The health care provider should review the clinical indicators in the guideline to determine the appropriate level of care. The guideline has been revised to read in Table I. Primary Level of Care, Description, "This level of care may be used for any level of severity of injury according to the clinical indicators." COMMENT: A suggestion was made to delete biofeedback and facet injections from Table I, Primary Level of Care to resolve the conflict with subsection (f) (3)(C). RESPONSE: The commission disagrees. Subsection (f)(3)(C) relates to diagnostic procedures (i.e., diagnostic facet injections) versus Table I. Primary Level of Care, which relates to the use of specific treatments (therapeutic facet injections). To further clarify that Table I is referring to therapeutic facet injections, the description has been changed to read "Therapeutic Facet Injection" in the guideline. Because biofeedback is not listed in (f)(3)(C), there is no conflict to resolve between the two sections. COMMENT: Concern was expressed that Functional Capacity Evaluations are recommended at all three levels of care, implying that a total of six Functional Capacity Evaluations may be allowed per injured worker. A suggestion was made to delete the reference to this evaluation in the secondary and tertiary levels of care since this type of testing is considered to be included in those programs as outlined in Commission on Accreditation of Rehabilitation Facilities (CARF). The commenter expressed concern at the validity of this type of testing performed in the primary and secondary levels of care. RESPONSE: The commission disagrees. Although Functional Capacity Evaluations are listed in all three levels of care as a type of test that would be considered appropriate, the use of such a test is dependent on the clinical condition and needs of the injured worker. In some instances, the Functional Capacity Evaluation may be performed solely to determine the injured worker's ability to return to work; this may need to be done in any level of care and should not be limited only to the tertiary level of care. COMMENT: A suggestion was made to add the following goal to Table II, Secondary Level of Care: "This is best accomplished by return-to-work in some modified duty." RESPONSE: The commission disagrees. The need to return to work is addressed in the section titled "Goal of Secondary Intervention" which states "Arresting and preventing progressive physical deconditioning and appearance of psychosocial barriers to work return with a reactivation process, generally associated with the post-acute and early postoperative periods." COMMENT: A suggestion was made to add modified work programs and delete Manipulations Under Anesthesia from Table II, Secondary Level of Care. The commenter also suggested deleting Manipulations Under Anesthesia from Table III. Tertiary Level of Care. Another commenter expressed concern with the listing of both manipulation and manipulation under anesthesia on the table for tertiary level of care. This commenter expressed concerns that manipulations under anesthesia were more risky and not demonstrably more effective than routine manipulations. RESPONSE: The commission disagrees. Interdisciplinary programs are mentioned under the section titled "Types of Intervention", and the possible need for a transitional period of modified duty is mentioned in the section titled "Return to Work Issues" in the table listed by the commenters. Manipulation under anesthesia as a treatment intervention was in the initial draft that was submitted to the MAC by the physician subcommittee. It was a consensus decision of the MAC on March 11, 1994 that manipulation under anesthesia was appropriate as a treatment option for both secondary and tertiary levels of care based on the clinical expertise of the health care providers on the MAC. COMMENT: A suggestion was made to revise the goals in Table III, Tertiary Level of Care to read "Return to full duty may not always be possible and does allow for referral by statute." RESPONSE: The commission disagrees. This table, in the section titled "Return to Work Issues", addresses that issue. Specifically, the table states: "The severe level of severity allows return to work within four-six months with or without a transitional period of modified duty (not to exceed four months). Treatment response to tertiary interventions will ultimately allow a return to full duty (or permanently modified) work. There will likely be some limitations restricting medium-to-heavy jobs accompanied by some permanent impairment, but with the injured worker always able to reach MMI following surgical and/or primary, secondary and/or tertiary nonoperative interventions. Other outcomes include vocational rehabilitation, or voluntary decision to leave the work force." COMMENT: Concern was expressed that the "Surgical Intervention Table" implies that symptoms suggestive of a surgically treatable lesion should be a prerequisite to surgery. It was recommended that the presentation of symptoms alone should not be enough to warrant surgery; it was recommended that there should be objective findings of a spinal lesion anatomically compatible with the patient's complaint prior to proceeding with surgery. RESPONSE: The commission disagrees that a change is needed. Table IV, Surgical Intervention, Clinical or Behavioral Indicators, number (3) states that," Surgery would not occur except on objective findings of structural defects." This sentence answers to commentator's concern that the presentation of symptoms would warrant the necessity for surgery. COMMENT: Concern was expressed by the commenter that certain types of intervention listed in the primary level of care were inappropriate at this level of care and subject to overuse. The commenter specifically mentioned back schools, neuromuscular re-education, epidural steroid injections, and trigger point injections. RESPONSE: The commission disagrees. It is important to initiate patient education and pain control early in the treatment process to ensure the cooperation and rapid recovery of the injured worker. COMMENT: A suggestion was made to substitute the word "Occupational" for the word "Behavioral" in Tables I-IV in the Levels of Care. In addition, the suggestion was made to add acupuncture to the list of interventions in Table I and II. RESPONSE: The commission disagrees. The purpose of that portion of the tables for level of care titled "Clinical or Behavioral Indicators" was to provide a list of signs and symptoms which should be present at each level of care. This list of signs and symptoms is not tied to the injured worker's work behavior. Acupuncture is not separately listed but may be used if beneficial for pain/symptom control. COMMENT: Concern was expressed that the injured worker must apparently "fail" all other levels of care prior to receiving a referral for a pain care specialist. As currently written, it would prevent timely selection of patients who are not likely to respond to primary work hardening alone. Earlier evaluation by appropriately trained specialists would allow this small group of nonresponders to have appropriate and early intervention in order to optimize conservative treatment modalities as well as allow timely application of interventional techniques likely to have a greater success early than late in the course of these diseases. RESPONSE: The commission disagrees that the injured worker must "fail" all other levels of care prior to receiving a referral for a pain care specialist. In subsection (e)(2)(F), titled Ground Rules, the guideline states that: "The injured worker may move between levels of care or utilize interventions in more than one level of care simultaneously, depending on clinical indicators." COMMENT: Concern was expressed that further clarification was needed in the guideline to clearly distinguish between return to work programs and pain management programs. It was suggested that pain management programs be listed separately in the intervention section of the Levels of Care tables. RESPONSE: The commission agrees that clarification is needed and added definitions in the glossary for work conditioning, outpatient medical rehabilitation, and chronic pain management. In the table for the tertiary level of care of the guideline, "Chronic Pain Management" is listed separately under "Interdisciplinary Programs". COMMENT: Concern was expressed with the perceived assumption that failed surgery automatically triggers mental health evaluation and treatment and that this is the only route for subsequent therapy. Mental health approaches should be combined with physical interventional pain without additional surgery in most instances. The cost savings are truly remarkable if interventional pain modalities are incorporated in the model of the Spine Treatment Guideline. RESPONSE: The commission disagrees that this assumption is present in the guideline. The commission acknowledges the commenter's concerns that chronic or intractable pain is not separately addressed in the guideline. However, pain treatment is mentioned in all three tables addressing the levels of care. In the primary level of care, "pain/symptom control", "behavioral pain management/relaxation training" and "biofeedback" are mentioned. In the secondary level of care, "behavioral pain management/relaxation training", and "biofeedback" are mentioned. In the tertiary level of care, "behavioral pain management/relaxation training" and "chronic pain management" are mentioned. A ground rule has been added to the guideline which states: "Although preoperative educational programs and chronic pain management programs are not specifically outlined, the intent of this guideline is not to eliminate or prohibit their use. When deemed medically necessary, these programs may be considered appropriate types of intervention to be utilized." In addition, the commission plans the formation of a work group at a later date to address criteria for pain management programs. COMMENT: A suggestion was made that the first sentence in the "Return to Work Issues" column of Table II, Level of Care should read, "The moderate level of severity allows full return to work in less than six months with or without a transitional period of modified duty." RESPONSE: The commission agrees with the need to clarify this section. This section has been revised to read: "The moderate level of severity is appropriate for a patient medically expected to return to work in less than six months, either with a full release or at a minimally modified duty expected to last three months or less." COMMENT: Concern was expressed that MMI would be utilized if a patient refuses to participate in what is perceived to be an ineffective means of treatment. The commenter appears to be concerned that the guideline does not specifically outline the contents of any treatment program other than physical medicine or mental health evaluation and treatment and expresses concern that the contents of the chronic pain management program mentioned in the treatment tables is not specifically delineated. RESPONSE: The commission agrees. References combining patient noncompliance with a resultant determination of Maximum Medical Improvement were deleted from the treatment guideline. This issue will be addressed in proposed amendments to other commission rules. The following comments were received regarding pain management. COMMENT: Concern was expressed that the guideline did not appear to address the problem of chronic or intractable pain in the back injury patient except for referrals to mental health treatment programs or surgical intervention. Concern was expressed that the descriptions for the levels of care appear to "arbitrarily exclude patients from treatment". RESPONSE: The commission disagrees. Pain treatment is mentioned in all three tables addressing the levels of care. In the primary level of care, "pain/symptom control", "behavioral pain management/relaxation training" and "biofeedback" are mentioned. In the secondary level of care, "behavioral pain management/relaxation training", and "biofeedback" are mentioned. In the tertiary level of care, "behavioral pain management/relaxation training" and "chronic pain management" are mentioned. The purpose of the treatment guideline is to clarify those services that are to be considered reasonable and necessary for both operative and nonoperative treatment of a worker with a spinal injury. The guideline clearly states throughout the document that a small percentage of injured workers will fall outside the guidelines recommended and will therefore require either more or less treatment than is outlined in the document. In addition, the guideline clearly states that the recommendations contained in the guideline are not to be used as the sole reason for denial of treatment or services. The commission recommends the formation of a work group at a later date to address criteria for pain management programs. COMMENT: Concern was expressed by commenters that interventional pain treatment techniques were not included in the guideline. Interventional pain management usually is not surgical and is done to achieve one or more of the following objectives: a. lesion specific delivery of medications to damaged nerve roots; b. release of entrapped nerve roots from scars; c. complete therapeutic neurodestructive procedures (e.g., injection of neurolytic substances, cryoneurolysis, and radiofrequency thermocoagulation); d. establish diagnosis using only diagnostic procedures (e.g., nerve sleeve injections and facet injections) A suggestion was also made that consideration be given to including interventional pain procedures such as spinal cord or peripheral nerve stimulation and/or implantable infusion pumps for spinal opiod therapy in the guideline. Suggestions were made that the CPT codes for these procedures (e.g., 64555 (PNS), 63650 (SCS), 63655 (SCS), 63685 (SCS), 63750 (Impl.Inf.), 63780 (Impl.Inf.), 64575 (PNS), and 64590 (PNS)) be added to the Surgical Treatment Code Legend and to the Surgical Algorithms. RESPONSE: The commission agrees. The guideline in the ground rules has been rewritten as follows: "Interventional pain procedures may include spinal cord or peripheral nerve stimulation and/or implantable infusion pumps. CPT codes for these procedures include 64555, 63650, 63655, 63685, 63750, 63780, 64575, and 64590. These procedures are performed to achieve one or more of the following objectives: a. lesion specific delivery of medications to damaged nerve roots; b. release of entrapped nerve roots from scars; c. complete therapeutic neurodestructive procedures (e.g., injection of neurolytic substances, cryoneurolysis, and radiofrequency thermocoagulation); d. establish diagnosis using only diagnostic procedures (e.g., nerve sleeve injections and facet injections)." COMMENT: A suggestion was made that a chronic pain treatment continuum be established within the guideline with an emphasis on a multi-disciplinary approach to include limited surgical intervention such as those treatments mentioned in the previous paragraph as well as neurobehavioral modalities such as cognitive and behavioral techniques, family therapy and education, operant conditioning, support group therapy and general patient education. RESPONSE: The commission disagrees. The commission acknowledges that, although various types of pain management programs are mentioned in all three levels of care tables, specific delineation of the components of a chronic pain management program are not specified in this guideline. The commission recommends the formation of a work group at a later date to address criteria for pain management programs. RESPONSE: Concern was expressed that the guideline did not endorse payment of such treatment as dorsal column stimulation and implanted intrathecal opiod delivery devices. COMMENT: The commission agrees. The treatment guideline has been rewritten to include interventional pain management. Ground Rule (N) allows for interventional pain procedures. The following comments were received regarding assessments and evaluations. COMMENT: One commenter suggested that, in the section on Assessments/Evaluations, orthopedic and neurologic tests should be added to the description of physical examination and neurological evaluation. The commenter also expressed concern that the methods suggested for testing and evaluating strength and endurance may not be accurate. RESPONSE: The commission disagrees. The physical examination/neurological evaluation referred to by the commenter is, according to the description in the previous paragraph, a "qualitative estimate of the injured worker's physical or functional ability." The quantitative measurements of the injured worker's physical or functional ability are covered in subsequent paragraphs describing a physical capacity evaluation and a functional capacity evaluation. COMMENT: Concern was expressed that proper patient selection for specific modalities (work hardening, etc.) should only be done by specialists trained and practicing full time in the field of pain medicine. Concern was also expressed that treatment for tertiary care be provided by those specialists trained to provide the type of care described in the table. The guidelines currently allow any and all practitioners to perform interventional techniques for which they have limited training and exposure. Proper selection of patients is the key to limiting expense wasted on candidates who have almost no chance of responding to an otherwise appropriate and effective treatment. Proper referral guidelines for treating physicians would lower expense and improve outcomes for these patients. RESPONSE: The commission disagrees. It is the role of the treating doctor to appropriately refer the injured worker to the programs necessary for treatment of his/her injury. The Medical Fee Guideline states in the Medicine Ground Rules, (I)(A), that those services provided must be performed by a licensed health care practitioner performing within the scope of practice for which the practitioner is licensed. The newly adopted Mental Health Treatment Guideline provides criteria for referral to chronic pain management programs in subsection (i)(3). COMMENT: Concern was expressed that stronger language was needed in subsection (h)(1)(C) regarding possible risk factors, including pre- and postoperative risk factors, and the need to treat these factors as well as the spine injury. The commenter also suggested that payment be allowed for treatment of risk factors. RESPONSE: The commission disagrees that stronger language is needed in this section. As is outlined in subsection (b)(2)(A), it is the responsibility of the treating doctor to identify both the extent and severity of the injury, and to identify and separately treat those symptoms not related to the compensable injury. The Texas Labor Code, sec.408.021(a,) states that "An employee who sustains a compensable injury is entitled to all health care reasonably required by the nature of the injury as and when needed. The employee is specifically entitled to health care that: (i) cures or relieves the effects naturally resulting from the compensable injury; (ii) promotes recovery; and (iii) enhances the ability of the employee to return to or retain employment." It is not the purpose of this guideline to expand or limit coverage of the injured worker. Payment for services rendered which are not causally related to the compensable injury, as defined in the above quotation, is not something which can be recommended by this guideline. The following comments were received regarding the treatment algorithms. COMMENT: Concern was expressed that although education is encouraged, there is no separate mention of specific programs for education such as back schools, PEP programs, or education by the surgeon. A suggestion was made to include a preoperative educational plan in the Perioperative Algorithm. Pertinent statistical findings were briefly summarized to provide support for the inclusion of "preoperative education plan" into the guideline. RESPONSE: The commission disagrees that there is a need to include the suggested programs in the surgical algorithms. Although patient education is not specifically mentioned in the surgical algorithms, it is repeatedly mentioned in the other tables outlining levels of care. In addition, communication of the treatment plan and the expected outcome to the injured worker is part of the function of all health care providers as outlined in subsection (c)(5)(A). The commission recommends the formation of a work group at a later date to address the criteria for a preoperative education program. In addition, a ground rule has been added to the guideline which states: "Although preoperative educational programs and chronic pain management programs are not specifically outlined, the intent of this guideline is not to eliminate or prohibit their use. When deemed medically necessary, these programs may be considered appropriate types of intervention to be utilized." COMMENT: A question was raised regarding the meaning of "MMI (60-80%)" as listed in Chart 1 of the Surgical Algorithms. RESPONSE: This box, if followed back to the beginning of the chart, indicates that approximately 60% to 80% of the injured workers depending on the study cited, respond to conservative, or nonoperative, treatment and return to work within the first eight weeks of care. The following comments were received regarding the glossary. COMMENT: A suggestion was made to expand the glossary with terms/definitions for better understanding. The terms suggested for the glossary were as follows: a. focus review b. single point of contact c. inter/multidisciplinary programs d. change "intervertebral disc disorder" to "intervertebral disc syndrome" e. separate the definitions/ratings for "sprain" and "strain" f. time limited g. acceptable standards of care h. algorithm i. assessment/evaluation j. clinical plateau k. consulting doctor l. decompensating m. denial parameters n. diagnosis o. diagnostic module p. diagnostic tests q. examination r. first doctor s. frequency of intervention t. functional capacity u. medical necessity v. module w. objective findings x. physician y. primary/secondary/tertiary care z. proper clinical documentation aa. reason for denial bb. referral cc. secondary treatment dd. static ee. subjective complaints ff. treatment module gg. treatment plan RESPONSE: The commission agrees with recommendations by commenters to add the following definitions: a. Interdisciplinary programs: programs in which the delivery of services is provided by more than one type of health care service (e.g., occupational therapy, physical therapy, counseling services, medical services). Examples of this type of program include work hardening, outpatient medical rehabilitation, and chronic pain management. b. Clinical plateau: a period of time of relative stability in which the injured worker displays minimal or minor changes in his/her condition. c. Consulting doctor: a doctor who provides an opinion or advice regarding the evaluation and/or management of a specific problem, as requested by the treating doctor, the commission, or the insurance carrier. A consulting doctor may only initiate diagnostic and/or therapeutic services with approval from the treating doctor. d. Referral doctor: a consulting doctor who initiates health care treatments at the request of the treating doctor. e. Sprain: an injury to a ligament i. Mild (Grade 1): only a few fibers are torn; ligament is mostly intact and the joint is stable; ii. Moderate (Grade 2): more fibers are torn, resulting in some instability with abnormal joint motion iii. Severe (Grade 3): ligaments are completely disrupted and instability may be severe (synonymous with marked). f. Strain: an injury to a muscle i. Mild (Grade 1): only a few fibers are torn; muscle is mostly intact and functional; ii. Moderate (Grade 2): more muscle fibers are torn resulting in muscle pain with contraction; iii. Severe (Grade 3): tendons are completely disrupted, extreme pain and loss of use of muscle. g. Treatment plan: this is a written document which must contain the following components: i. type of intervention/treatment modality ii. frequency of treatment; iii. expected duration of treatment; iv. expected clinical response to treatment; and v. specification of a re-evaluation timeframe. The commission disagrees with the suggested need for definitions for the remaining terms. These terms are clearly defined within the context of the guideline and need no further clarification. The following general comments were received regarding the Spine Treatment Guideline. COMMENT: A suggestion was made to incorporate recommendations adopted by the federal government regarding the treatment of chronic pain. RESPONSE: The commission disagrees with the need to incorporate recommendations adopted by the federal government regarding the treatment of chronic pain. Chronic pain programs are not specifically addressed in this guideline. However, consideration will be given to further addressing the needs of injured workers experiencing chronic pain in a separate guideline to be developed at a later date, and the information contained within the federal guidelines will be examined for use in the future guideline. A ground rule has been added to the guideline which states: "Although preoperative educational programs and chronic pain management programs are not specifically outlined, the intent of this guideline is not to eliminate or prohibit their use. When deemed medically necessary, these programs may be considered appropriate types of intervention to be utilized." COMMENT: Concern was expressed that the listing of cell saver as part of the routine anesthetic clearly has to be an error, as the cell saver demands significant manpower, and its use should be reimbursed at a higher level than establishment of central lines, which carries a separate reimbursement. RESPONSE: The commission disagrees. The commenter is referring to the proposed ground rules for the anesthesia section of the Medical Fee Guideline. The rule to which the commenter is referring is not contained in, nor does it specifically refer to, the Spine Treatment Guideline. The concerns raised by the commenter will be considered when revising the proposed ground rules for the Medical Fee Guideline. COMMENT: Concern was expressed that the acute pain service lists only intravenous patient controlled analgesia when in fact some of the injured workers demand long term epidural catheter placement and infusions, intrathecal catheter placement and infusions, intrapleural catheter placements and infusions, and peripheral nerve blocks and infusions, which should be appropriately compensated on the basis of American Society of Anesthesiologists Relative Value Guides. RESPONSE: The commission disagrees. The services listed by the commenter are not present in the treatment guideline but appear to be part of the proposed ground rules for revisions to the Medical Fee Guideline. This guideline does not address specific modalities for pain control; treatment for chronic pain will be addressed in a future guideline. The concerns regarding reimbursement for those services will be considered when revising the proposed ground rules for the Medical Fee Guideline. COMMENT: Concern was expressed that Texas has a number of academic institutions where physicians in training are used. The supervision of these physicians does not fall under the nurse anesthesia permissible limit of four; the maximum allowable by the training accrediting agencies is two. It is recommended that the reimbursement shall remain the same as it is now. Reimbursement for pain procedures use the ASA Relative Value Guide. RESPONSE: The commission disagrees. The guideline does not address the issue of reimbursement. The purpose of a treatment guideline is to address the diagnosis, treatment, and rehabilitation of the injured worker. Reimbursement of the services described in the treatment guideline are discussed in detail in the Medical Fee Guideline. COMMENT: Concern was expressed by a commenter that requiring preauthorization for services listed in the guideline would cause a delay in the provision of treatment to the injured worker. RESPONSE: The commission disagrees. References to the specific contents of the preauthorization rule have been deleted from the guideline. A sentence has been inserted in the guideline which states: "Preauthorization of any treatments or services will be as required in the commission's preauthorization rule." COMMENT: Support was expressed regarding the continued requirement for preauthorization of certain types of treatment. It was felt that preauthorization was necessary to continually monitor the treatment rendered to the injured worker to ensure that he/she received appropriate care in a timely manner. RESPONSE: The commission agrees. COMMENT: A suggestion was made by commenters to return the Spine Treatment Guideline to either the original or the combined work group for further review and revision. RESPONSE: The commission disagrees. The guideline contains input from both the original and combined work groups in a more concise format. The guideline was presented to the MAC (which included the members of the combined work group) prior to its publication in the Texas Register . A return of the guideline to the original work group would limit input by health care providers solely to MD and DO input. A return of the guideline to the combined work group, while it would encompass all health care providers, would unnecessarily delay the production of this document and would require re-initiation of the guideline process. Comments on the guideline were extensive and resulted in revision to the rule as proposed. Re-publication would most likely result in duplicate comments and would therefore not be productive. COMMENT: A suggestion was made that the preamble be revised to indicate that the proposed Spine Treatment Guideline represents minimum community standards of usual and customary care, applicable only 80% of the time and should not be used to deny treatment for patients falling outside the guideline, and that it is a consensus medical document, subject to revision. It was expressed that, although the rule stipulates otherwise, the guideline would be used by carriers as the sole determinant for continuation of or denial of care. Suggestion was also made that the phrase "Medical services consistent with this guideline are presumed reasonable and necessary" be included in the ground rules. RESPONSE: The commission disagrees that the recommended language is needed. The purpose of the treatment guideline is to clarify those services that are considered to be reasonable and necessary for both operative and nonoperative treatment of a worker with a spinal injury. The guideline clearly states throughout the document that a small percentage of injured workers will fall outside the guidelines recommended and will therefore require either more or less treatment than is outlined in the document. In addition, the guideline clearly states that the recommendations contained in the guideline are not to be used as the sole reason for denial of treatment or services. The statement recommended is present in the introduction, subsection (b)(1) titled "Purpose". COMMENT: A comment was made that the insurance carriers did not participate in the development of this treatment guideline. RESPONSE: The commission disagrees. A primary general public member of the Medical Advisory Committee who was employed by a fourth party auditor, was involved in the combined work group which assisted in the development of this treatment guideline. In addition, comments from insurance carriers were received during the public comment process and were taken into consideration at that time. COMMENT: General comments were made expressing dissatisfaction with the development and revision of the proposed Spine Treatment Guideline. RESPONSE: The commission disagrees. Every effort was made by the commission to include the comments and suggestions of both the original and combined work groups in the creation of this document. The guideline was presented to the MAC (whose members include the combined work group) prior to its publication in the Texas Register. COMMENT: Support was expressed regarding the following subsections of the Spine Treatment Guideline: (b)(1), (d)(1)(B), (e)(2)(H), (e)(2)(N) and (O), and (e)(3)(D) and (g)(2)(A), Introduction, Diagnostic Procedures, Surgical Treatment Algorithms, Algorithms. RESPONSE: The commission agrees. COMMENT: Concern was expressed regarding the definition of "doctor", as outlined in the Spine Treatment Guideline. RESPONSE: The commission disagrees. The commenter is addressing the definition of "doctor" as defined in Texas Labor Code, sec.401.011. COMMENT: Concern was expressed regarding the definitions of body regions as outlined in the Spine Treatment Guideline. Specifically, concern was expressed that the ribs and thoracic spine were combined into one area (thorax), the lumbar and sacral areas were combined into one area (lumbosacral), and the pelvis was deleted. COMMENT: The commission disagrees. The commenter appears to be addressing the body areas as defined in the proposed revisions of the Medical Fee Guideline ground rules. This document is not yet available for public comment, although those comments pertinent to that document will be taken into consideration, along with other comments from the general public, when preparing revisions to the ground rules. RESPONSE: Concern was expressed regarding the information contained in the surgical algorithms as set out in the proposed Spine Treatment Guideline. COMMENT: The commission disagrees. The formation of the surgical algorithms, and the information contained within each algorithm, was based on input from the members of both the original and combined work groups, each of which recommended the use of algorithms as an appropriate method of conveying complex information. RESPONSE: Suggestions were made for the following revisions in terminology: a. where it currently states "multidisciplinary assessment", revise the phrase to refer to "multidisciplinary medical assessment". b. where it currently refers to "injured worker", refer instead to "patient". RESPONSE: The commission disagrees. Not all interdisciplinary or multidisciplinary programs are medically directed; to require that the assessment be medically directed would limit access to certain nonmedically directed programs such as work hardening. The use of the phrase "injured worker" is consistent with the currently adopted Mental Health Treatment Guideline which also uses that phrase. COMMENT: General support of the Spine Treatment Guideline was expressed. COMMENT: General objection to the adoption of the proposed Spine Treatment Guideline was expressed. COMMENT: Concern was expressed that the guideline will limit many physicians from referring to specialists, such as orthopedic surgeons, neurosurgeons, or neurologists, and many tests will not be performed due to the criteria that is described. RESPONSE: The commission disagrees. The purpose of the guideline is to identify a normal course of treatment for both operative and nonoperative care of the worker with a spine injury. This guideline is not to be used as a fixed treatment protocol, nor is it to be used as the sole reason for denial of or access to care. COMMENT: Concerns were raised and answered regarding the liability issues of neuroaugmentation and spinal pumps. The questions and answers include: a. Will the insurance company be liable? This is an accepted and recognized procedure by Medicare, Blue Cross/Blue Shield and other insurance carriers and there is evidence of its efficacy (50% to 70%) in selected patients who have failed all other treatments. b. Will the State be liable for the deaths? ERSA laws technically do not protect governmental bodies from law suits. c. Will the treating physician be liable? Considering current judgment and practices the physician seems to have the most liability in treating a patient where an accepted procedure is not obtainable. This would most closely align at this point in time to managed care interfering with the physician's decision for treatment. This was a series of questions/comments and did not specifically address the contents of the guideline. COMMENT: Concern was expressed that an outcome-based reporting system is not mentioned in the guideline. RESPONSE: The commission disagrees that an outcome-based reporting system should be specifically mentioned in the guideline. Throughout the guideline there are criteria established regarding documentation requirements. Through documentation, outcomes can be generated to show progression of recovery. It is not the intent at this time to mandate computer generated outcome-based reports by all health care providers. This type of reporting should remain within the domain of the health care provider. COMMENT: Concern was expressed that the chronological severity index (CSI) was deleted. RESPONSE: The commission disagrees that the CSI was present in either Draft 8, which was the document presented in the MAC or in the previous proposal of this treatment guideline. The chronological severity index referred to by the commenter was edited out during the revision process by the subgroup of the MAC. COMMENT: Concern was expressed that the guideline does nothing to eliminate or lessen the amount of paperwork surrounding the treatment of the injured worker. RESPONSE: The commission disagrees. The purpose of this guideline was to provide an outline of those services which are considered to be reasonable and necessary for operative and nonoperative care of the injured worker with a spinal injury. This guideline, while it does not subtract from the amount of paperwork associated with the treatment of the injured worker, does provide an outline of expectations regarding documentation and course of action. This should make the process of treating the injured worker easier by providing a readily available reference or standard to which both the health care provider and insurance carrier can refer when determining the appropriateness of the proposed treatment plan or when performing a review of the injured worker's care. COMMENT: Information was provided on the Omega Rehabilitation Center's Functional Restoration Therapy programs. This comment is more informative rather than a true comment on the Spine Treatment Guideline. COMMENT: Suggestions were made regarding the correction of certain words/phrases as they currently appear in the guideline: a. change "phases" to "levels" when referring to levels of care throughout the document; b. change the phrase "Assessments/Evaluations" to read "Evaluations/Assessments" c. insert the word "medically" in the phrase "services that are reasonable and medically necessary for operative and nonoperative care to the spine."; d. in the section stating the responsibilities of the Primary Gatekeeper, the following additions and deletions are necessary: i. insert after "management by other health plans" the words "for all further evaluations and care after the assessment has been made that the injury is non- work related." ii. delete subsection (c)(2)(A)(vi) which refers to the appropriate cost of the services; the commenter felt that this function was not within the domain of the treating doctor. e. separately define consulting and referral doctor in the glossary; f. in the Application Tables, the following revisions were suggested: i. re-number #3 in the table "Initiation of Treatment-Treating Doctor", "Assessment/Evaluation and Treatment" to be #5 and re-number #4 and 5, respectively, as #3 and #4; ii. in the same chart, under "Documentation Requirements", #8 should be re- numbered as #4 and the remaining items re-numbered respectively. The commission agrees to the following recommended revisions: 1. the substitution of "levels" for "phases" when referring to levels of care. 2. the insertion of the word "medically" in the phrase "services that are reasonable and medically necessary for operative and nonoperative care to the spine". 3. separately defining consulting and referral doctor in the glossary. 4. the suggested re-numbering listed above in the Application Tables. The commission disagrees with the following recommended revisions: 1. the insertion of the phrase "for all further evaluations and care after the assessment has been made that the injury is non-work related". 2. the deletion of subsection (c)(2)(A)(vi) which refers to the appropriate cost of services. 3. the re-ordering of the phrase "Assessments/Evaluations" to "Evaluations/Assessments". The reason for the disagreement is as follows: 1. not all treatment for nonrelated health care services is due to a noncompensable injury. The injured worker may have a co-morbidity, such as heart disease or diabetes, which is not related to the compensable injury but which still requires care by the treating doctor. 2. this subsection recommended for deletion is part of the responsibility of the treating doctor, as defined in of the Texas Labor Code, 408.025(b)which states that "The treating doctor shall be responsible for maintaining efficient utilization of health care." 3. there is no justification for reversing these words. COMMENT: A suggestion was made by a commenter to delay the adoption of the proposed treatment guideline until the Agency for Health Care Policy and Research (AHCPR) study can be reviewed and those parts of the federal recommendations which are pertinent to this guideline included in the contents of the proposed treatment guideline. RESPONSE: The commission disagrees with the proposal to delay the adoption of the Spine Treatment Guideline. The guideline is a medically sound document. The commission presented the AHCPR study to the MAC, outlining the differences and similarities between the two documents. The following comments were received regarding the gatekeeper. COMMENT: Concern was expressed in regards to subsection (c)(2), Primary Gatekeeper Responsibilities. It was recommended that if the commission wants the treating doctor to act as a gatekeeper, which is an additional duty, specific guidelines need to be promulgated as to: (1) increased weight of evidence as to the treating doctor's opinions and (2) reimbursement for the mandated case management services. The treating doctor should not and cannot be responsible for the actions of others beyond his/her control. RESPONSE: The commission disagrees that charges need to be changed to reflect an additional increase in reimbursement for the primary gatekeeper. The responsibilities of the primary gatekeeper, as outlined in subsection (c) (2) are a delineation of the general statutory requirements as previously outlined in subsection (c)(1)(A)through (E). This is a clarification of the role of treating doctor (i.e., primary gatekeeper). The new rule is adopted under the Texas Labor Code, sec.402.061, which authorizes the commission to adopt rules necessary to administer the Act, the Texas Labor Code, sec.413.011, which authorizes the commission to establish by rule medical policies and guidelines relating to necessary treatments for injuries, and the Texas Labor Code, sec.413.013, which authorizes the commission to establish by rule a program for prospective, concurrent, and retrospective review and resolution of a dispute regarding health care treatments and services; and to establish by rule a program for the systematic monitoring of the necessity of treatments administered and fees charged and paid for medical treatments or services, including the authorization of prospective, concurrent, or retrospective review under the medical policies of the commission to ensure that the medical policies or guidelines are not exceeded. sec.134.1001. Spine Treatment Guideline (a) Table of Contents. The following headings and their corresponding subdivisions comprise a table of contents for this section. (1) Introduction-subsection (b). (A) Purpose-subsection (b)(1). (B) Goals-subsection (b)(2). (C) Development Process-subsection (b)(3). (D) Philosophy of Care-subsection (b)(4). (2) Role of Primary Gatekeeper subsection (c). (A) Statutory Requirements subsection (c)(1). (B) Primary Gatekeeper Responsibilities subsection (c)(2). (C) Referrals subsection (c)(3). (D) Diagnostics subsection (c)(4). (E) Expectation and Compliance subsection (c)(5). (3) Application Instructions for Involved Parties subsection (d). (A) Concepts and Governing Principles subsection (d)(1). (B) Application Matrix Table subsection (d)(2). (4) Ground Rules subsection (e). (A) Introduction subsection (e)(1). (B) Ground Rules subsection (e)(2). (C) General Documentation Requirements subsection (e)(3). (D) Documentation Requirements for Unrelated or Intercurrent Illness subsection (e)(4). (5) Diagnostic Procedures subsection (f). (A) Introduction subsection (f)(1). (B) List of Diagnostic Interventions subsection (f)(2). (C) Time Recommendations for Listed Procedures subsection (f)(3). (6) Levels of Nonoperative Care subsection (g). (A) Introduction subsection (g)(1). (B) Criteria in Primary Intervention Phase Primary Level of Care subsection(g)(2). (C) Referral Criteria in Secondary Intervention Phase Secondary Level of Care subsection (g)(3). (D) Referral Criteria in Tertiary Intervention Phase Tertiary Level of Care subsection (g)(4). (E) Criteria to Distinguish between Secondary and Tertiary subsection (g)(5). (F) Levels of Care Tables subsection (g)(6). (7) Assessments/Evaluations subsection (h). (A) Interdisciplinary Assessment subsection (h)(1). (B) Physical Capacity and Functional Capacity Assessments subsection (h) (2). (C) Appropriate and Inappropriate Testing subsection (h)(3). (8) Treatment Algorithms subsection (i). (A) Introduction to Algorithms subsection (i)(1). (B) Surgical Treatment Code Legend subsection (i)(2). (C) Initial Approach to Treatment of Spinal Injury Chart 1 subsection (i)(3). (D) Fracture and/or Dislocation Chart 2 subsection (i)(4). (E) Soft Tissue Injury Chart 3 subsection (i)(5). (F) Peri-Operative Algorithm Chart 4 subsection (i)(6). (G) Surgical Treatment Chart 5 subsection (i)(7). (H) Surgical Treatment Subchart Chart 5A subsection (i)(7)(A). (I) Surgical Treatment Subchart Chart 5B subsection (i)(7)(B). (J) Surgical Treatment Subchart Chart 5C subsection (i)(7)(C). (K) Treatment Continuation Chart 6 subsection (i)(8). (9) Glossary subsection (j). (10) Bibliography subsection (k). (b) Introduction. (1) Purpose. The purpose of this guideline is to clarify those services that are reasonable and medically necessary for operative and nonoperative care to the spine for the injured workers of Texas. This guideline identifies a normal course of treatment. It is anticipated that there will be injured workers who will require less treatment than the average and other injured workers who will require more treatment. This is a guideline and shall not be used as the sole reason for denial of treatments and services. (2) Goals. The following subparagraphs outline the primary goals of this guideline: (A) to assist all parties with regard to the appropriate treatment and management of disorders of the spine; (B) to establish elements against which aspects of care can be compared; (C) to establish a guideline to identify clinically acceptable courses of treatment; (D) to establish documentation standards which support the appropriateness of the level of service; and (E) to provide a mechanism of prospective, concurrent, retrospective review for efficient and effective health care utilization. (3) Development Process. The Texas Workers' Compensation Commission (TWCC), in conjunction with health care providers and other parties in the system, have developed clinical and diagnostic treatment guidelines. Following are three major components in the guideline development process. (A) Design and Methodology. A search of all 50 workers' compensation state agencies revealed that only a few had developed treatment guidelines. The format and design of these guidelines were mainly in narrative presentation. Research revealed an algorithmic approach to be the most understandable. Therefore, the focus of this treatment guideline is toward an algorithmic approach versus straight text. (B) Provider Work Group. Research into successful guidelines developed in the private sector identified that involvement from provider work groups achieves the best outcome regarding clinical policy development. (C) Public Evaluation. The evaluation of the developed guideline should be broad and include comments from employees, employers, health care providers and insurance carriers. (4) Philosophy of Care. The health care of the injured worker is a coordinated team effort. All parties including employees, employers, health care providers, insurance carriers and the Texas Workers' Compensation Commission should promote quality health care, injury specific treatment and appropriateness of care. Communication between all parties must remain open in order to achieve rapid recovery from the effects of the injury. This communication should promote a timely return to modified or full duty work that takes into account the job demands and the functional capabilities of the injured worker. (c) Role of Primary Gatekeeper. (1) Statutory Requirements. The following sections of the Texas Labor Code and specific Commission rules address key areas pertaining to those services that are reasonable and necessary for treatment of the spine. (A) sec.408.021(a). An employee who sustains a compensable injury is entitled to all health care reasonably required by the nature of the injury as and when needed. The employee is specifically entitled to health care that: (i) cures or relieves the effects naturally resulting from the compensable injury; (ii) promotes recovery; and (iii) enhances the ability of the employee to return to or retain employment. (B) sec.408.021(b). Medical benefits are payable from the date of the compensable injury. (C) sec.408.021(c). Except in an emergency, all health care must be approved or recommended by the employee's treating doctor. (D) sec.408.025(b). The commission by rule shall adopt reasonable requirements for reports and records to be made available to other health care providers to prevent unnecessary duplication of tests and examinations. (E) sec.408.025(c). The treating doctor shall be responsible for maintaining efficient utilization of health care. (2) Primary Gatekeeper Responsibilities. (A) The role of the treating doctor is an important role which requires the treating doctor to monitor all health care services being provided for the injured worker. These responsibilities of the treating doctor are vital aspects of the goal to ensure that the injured worker receives quality health care. This monitoring extends to ensure: (i) the identification of the extent and severity of the injury initially; (ii) the appropriateness of all services; (iii) the relatedness of all services to the workers' compensation injury; (iv) separation and referral of nonrelated health care services for management by other health plans; (v) whether the treatment is duplicative, necessary and/or effective; (vi) the appropriate cost of the services; (vii) the quality of the treatment; and (viii) enhancement and promotion of effective communication among all involved parties. (B) Refer to sec.126.9 of this title and sec.133.3 of this title for responsibilities of the treating doctor. (3) Referrals. The treating doctor is responsible for recommending timely and appropriate referrals. The treating doctor must clearly delineate the clinical rationale for all referrals. The documentation contained in the TWCC 64 should clearly outline whether the purpose of the referral is to corroborate the diagnosis and/or proposed course of treatment or to initiate ongoing treatment. It is appropriate for the treating doctor to document and explain the referral in the TWCC 61 or TWCC 64. Once a consultation or referral has occurred, the consulting or referral doctor should submit a summary report or initiate a case management phone call back to the treating doctor. This communication by the consulting or referral doctor is necessary to enable the treating doctor to meet his responsibility to submit a TWCC 64 every (60) days. (4) Diagnostics. Diagnostic work should be performed in accordance with the recommended testing and timeframes contained in this guideline. If the need arises to deviate from the guideline, then a clinical rationale must be provided which adequately substantiates the need for this deviation. The need to repeat previously completed diagnostic procedures due to the quality of the study may trigger a review. All health care providers involved in the treatment of an injured worker must share copies of all diagnostic studies, film and reports in order to avoid unnecessary duplication of procedures. Section 133.2 of this title (relating to Sharing Medical Reports and Test Results) addresses the need to share medical records, including diagnostic studies, to avoid duplication. Section 133.106 of this title (relating to Fair and Reasonable Fees for Required Reports and Records) addresses reimbursement for copies of records. (5) Expectation and Compliance. (A) All health care providers must encourage injured workers to be active participants in their health care treatment regimens and must communicate to the injured worker realistic expectations regarding the potential outcome of this treatment regimen as it relates to his/her physical functioning and/or ability to return to work. Therefore, it is important to document the injured worker's compliance with his/her treatment regimen when reporting the progress of his/her recovery. (B) Health care providers must explain to the injured worker in clear terms the extent and severity of the injury and the treatment needed. Health care providers must define the symptomatology that is directly and/or indirectly related to the injury and specify treatment not covered under workers' compensation. (d) Application Instructions for Involved Parties. (1) Concepts and Governing Principles. (A) Health Care Provider. This guideline is to be used as a tool by the health care provider to establish the required elements to initiate and continue treatment. If, for example, a provider's treatment deviates from the guideline, documentation of a clearly delineated rationale for the need for this treatment would be required. (i) This guideline identifies typical treatment based on normal tissue healing responses for the average injured worker. (ii) It is expected that a subset of injured workers will be found to be outside the parameters of these guidelines. (iii) This guideline should be used as a tool which identifies the recommended treatment parameters for treatment of injured workers within the workers' compensation system. (iv) This guideline identifies the need to provide documentation which clearly explains the reason for the treatment, the relatedness to the workers' compensation injury and alternative treatment. (v) The health care provider also becomes aware of the need to educate the injured worker of health care treatment appropriate in the workers' compensation injury. (vi) This guideline recommends early return to work based upon the injured worker's functional capacity which includes ability, clinical status, and either full or modified job requirements. (B) Insurance Carriers. The insurance carrier should use this guideline to compare treatment prospectively, concurrently and retrospectively with the predetermined elements contained in the guides. (i) This document and its parameters serve only as a guideline and are not to be used as the sole reason for denial of treatments and services. (ii) This guideline provides a tool by which to monitor the injured worker's recovery process. (iii) This guideline serves as a tool to assist the insurance carriers in the medical audit process. (iv) This guideline is not to be used to direct care toward a specific health care discipline or to a specific type of treatment. It is the responsibility of the insurance carrier to provide specific documentation and rationale if treatment is denied. This rationale may include elements of the guideline. Additional information regarding the rationale for denial of treatment may also be derived from the injured worker's medical records and from the professional opinion of a peer review, if utilized. (v) It is expected that a subset of injured workers will be found to be outside the parameters of this guideline. (C) Medical Review Division. The Medical Review Division will use the guideline as a tool for the basis of their administrative review of prospective, concurrent and retrospective treatment. It will also be used as a tool in conducting on-site audits for both health care providers and insurance carriers. (D) Consulting or Peer Review Health Care Provider. This guideline should be used as a reference in advising the Medical Review Division and when the need for an unbiased medical opinion is indicated. The peer reviewer should use his/her clinical expertise in conjunction with the clinical intent of the guideline to address issues. (E) Injured Worker. It is essential the injured worker understands his/her role in complying with recommended treatment. The recovery and return to work process requires active cooperation of the injured worker. (F) Employer. It is the responsibility of the employer to report the compensable injury in a timely fashion to ensure that there is no delay in the treatment of the compensable injury. It is also the responsibility of the employer to work with the insurance carrier and health care providers to ensure that the injured worker is afforded the opportunity to return to work in either a modified or full employment capacity as rapidly as possible within the medical limitations of his/her injury. (2) Application Tables. See Figures (1)-(3) published in the Tables and Graphics Section of this issue of the Texas Register. (A) Initiation of Treatment. Figure 1: 28 TAC sec. 134.1001(d)(2)(A) (B) Ongoing Treatment. Figure 2: 28 TAC sec. 134.1001(d)(2)(B) (C) Ongoing Treatment (For other parties involved). Figure 3: 28 TAC sec.134.1001(d)(2)(C) (e) Ground Rules. (1) Introduction. The guidelines are not to be used as fixed treatment protocols. The guidelines reflect typical courses of intervention. It is acknowledged that, in atypical cases, treatment may fall outside these guidelines. However, those cases that exceed the guidelines level of treatment will be subject to more careful scrutiny and review and will require documentation of the special circumstances justifying that treatment. The guideline should not be seen as prescribing the type, frequency or duration of treatment. Treatment must be based on the injured worker's need and the doctor's professional judgment. (2) Ground Rules. (A) Not withstanding any other provision of this section, treatment of a work related injury must be: (i) adequately documented; (ii) evaluated for effectiveness and modified based on clinical changes; (iii) provided in the least intensive setting; (iv) cost effective; (v) consistent with this guideline or contain a documented clinical rationale for deviation from this guideline; (vi) objectively measured and demonstrate functional gains; and (vii) consistent in demonstrating ongoing progress in the recovery process by appropriate re-evaluation of the treatment. (B) Communication between all health care providers involved in treating the injured worker must ensure that all previous treatment and diagnostic tests are considered when developing a plan of treatment. All reports and records should be made available to all health care providers to prevent unnecessary duplication of tests and examinations (as provided in subsection (c)(2) and (3) of this section). (C) Patient education is an essential component in ensuring patient compliance to all treatment. Education is essential for the active cooperation of the patient in all aspects of health care and as a means to prevent re-injury. It is essential that the patient understand his/her role in the recovery and return to work process. (D) Although preoperative educational programs and chronic pain management programs are not specifically outlined, the intent of this guideline is not to eliminate or prohibit their use. When deemed medically necessary, these programs may be considered appropriate types of intervention to be utilized. (E) All parties in the workers' compensation system should work together to ensure that the injured worker returns to work at the earliest medically appropriate time. Return-to-work is an important therapeutic approach which benefits the injured worker. The health care provider should communicate with the injured worker, employer and the insurance carrier to coordinate a successful return to work. (F) The level of service should be the same as the health care provider's usual and customary level of service regardless of the payor system. (G) The injured worker may move between levels of care or utilize interventions in more than one level of care simultaneously, depending on clinical indicators. (H) Treatment durations are cumulative; however, it should not always be necessary to use full durations for any given level of care. (I) An initial mental health evaluation to determine the injured worker's readiness for the Work Hardening program may be performed prior to entrance into the program. This evaluation is not considered part of the Work Hardening program. Group therapy, provided by a Qualified Mental Health Provider, is considered to be part of the Work Hardening program. Individual therapy (i.e., one-to-one therapy with a Qualified Mental Health Provider) is not considered to be part of the Work Hardening program. Referral for this evaluation must come from the treating doctor. (J) The highest quality of patient care and clinical outcomes should be the standards by which referrals to secondary and tertiary care programs are determined. Documentation should be provided by the treating doctor which demonstrates the clinical progress of the injured worker's condition and evidence of the doctor's supervision. With this documentation present, both secondary and tertiary nonoperative care may be provided sequentially within the same facility or in facilities with linked ownership if self-referral or conflict of interest elements do not exist. (K) All health care providers providing services to an injured worker have the responsibility to substantiate in their documentation the level of service. All payors have the responsibility to review all documentation submitted as the basis for the treatment and services provided. (L) Any new treatment must meet acceptable standards of care and may be subject to review by the Texas Workers' Compensation Commission. (M) Documentation of significant neurological deficit may support early intervention (zero-six weeks) of MRI's and CT scans, which would better direct the course of treatment. (N) Indications for bone growth stimulators (internal and external) (CPT codes 20974 and 20975) include: (i) revision spinal fusion; (ii) history of spinal fusion or delayed union at different level; (iii) multiple level spinal fusion; (iv) use of allograft; (v) spondylolisthesis greater than grade two; and (vi) nonassociated high risk problems: e.g. metabolic bone disease, smokers, diabetics, obesity. (O) Interventional pain procedures may include spinal cord or peripheral nerve stimulation and/or implantable infusion pumps. CPT codes for these procedures include 64555, 63650, 63655, 63685, 63750, 63780, 64575, and 64590. These procedures are performed to achieve one or more of the following objectives: i. lesion specific delivery of medications to damaged nerve roots; ii. release of entrapped nerve roots from scars; iii. complete therapeutic neurodestructive procedures (e.g., injection of neurolytic substances, cryoneurolysis, and radiofrequency thermocoagulation); iv. establish diagnosis using only diagnostic procedures (e.g., nerve sleeve injections and facet injections) (P) Preauthorization of any treatments or services will be as required in the Commission's preauthorization rule. (Q) When it becomes necessary for an injured worker to travel in order to obtain appropriate and necessary medical care for a compensable injury, reimbursement for travel expenses is governed by sec.134.6 of this title. (R) The CPT codes in the current Medical Fee Guideline should be used. The CPT codes listed should not be used until they are adopted into a current Medical Fee Guideline. (3) General Documentation Requirements. (A) The health care provider's documentation is vital as an information source regarding the injured worker's injury and treatment. It also provides information which impacts income benefits. For these reasons, many of the Commission's rules have set time requirements for submission of required reports. For example, the TWCC 61 could be the first report submitted which informs the insurance carrier of the injury. The TWCC 64 provides medical information regarding the injured worker's clinical progress and the need for continuation of any income benefits. The TWCC 69 provides the determination of MMI and an impairment rating which may result in a change in income benefits. (B) Documentation should be provided by the health care provider to determine the level of care to be provided and the necessity for that care. The elements of that documentation may include: (i) A description of the injury, including the events surrounding that injury and the extent and severity of that injury; (ii) A description of any pre-existing condition(s), complicating conditions, and/or any non-related conditions; (iii) A plan of treatment, including proposed methods of treatment, expected outcomes, and probable duration of treatment; (iv) Updates to the plan of treatment as needed, including the clinical progress of the injured worker, and any revisions needed to the treatment plan in light of the injured worker's response to treatment; (v) Education/information provided to the injured worker regarding his injury and plan of treatment, and the injured worker's compliance with this plan of treatment; and (vi) Documentation substantiating the need for deviation from the guideline, if necessary. (C) Permanent impairment for compensable injuries in workers' compensation should be limited to these injuries and illnesses for which physicians are able to demonstrate objective findings. (D) The need for emergency treatment must be based on the doctor's professional judgment. This documentation must provide a clear explanation of the nature of the emergency, the injured worker's medical condition, complications which could occur as well as any irreversible conditions which occurred or could occur as a result of this event. (4) Documentation Requirements for Unrelated or Intercurrent Illness. Situations may arise where certain medical conditions need to be delineated or clarified prior to intervention. Treatment administered to other body areas (not a part of the original injury) or for a pre-existing medical condition(s) must be identified and the relation of this treatment to the compensable injury documented by the health care provider. If it appears that this treatment is not related to the compensable injury, the injured worker should be informed by the health care provider that this treatment may not be covered by the insurance carrier. The rationale for such treatment and its relation to the compensable injury should also be clearly documented for the insurance carrier by the health care provider. (f) Diagnostic Procedures. (1) Introduction. This subsection provides an average timeline in which to utilize certain listed diagnostic studies. The actual need for the diagnostic studies will be dependent on both the amount of time that has passed since the date of injury and on the injured worker's documented clinical condition. If the clinical condition of the injured worker is more severe, certain tests may be required sooner than is proposed in this guideline. (2) List of Diagnostic Interventions. The following subdivisions of this paragraph comprise a list of diagnostic interventions: (A) history and physical: (i) identify mechanism of injury; (ii) correlate patient's association of complaint with mechanism of injury; and (iii) correlate mechanism of injury and resultant body area(s) of injury; (B) plain X-ray: (i) five views; (ii) two views; or (iii) flexion/extension views; (C) laboratory tests; (D) myelogram; (E) CT scan; (F) MRI; (G) CT Scan augmented with myelography; (H) IV enhanced CT Scan; (I) gadolinium MRI-only with a history of prior surgery, failed back surgery, or to rule out an infection; (J) discography +/- CT scan; (K) radionucleotide bone scan: (i) nucleotide; (ii) dual photon; or (iii) P.E.T.; (L) EMG/evoked potential; (M) diagnostic selective nerve root injection-must be done under fluoroscopy; (N) diagnostic facet injection-done under fluoroscopy control both diagnostic & therapeutic; (O) physical capacity evaluation; (P) functional capacity evaluation; or (Q) mental health evaluation. (3) Time Recommendations for Listed Diagnostic Interventions. (A) Recommended treatment at zero to six weeks includes the diagnostic interventions listed in paragraph (2)(A)(B) and (C) of this subsection. (B) Recommended treatment at six weeks to four months includes the diagnostic interventions listed in paragraph (2)(D)-(I) and (K)-(M) of this subsection. (C) Recommended treatment at greater than four months includes the diagnostic interventions listed in paragraph (2)(J) and (N) of this subsection. (D) The diagnostic interventions listed in paragraph (2)(O)-(Q) of this subsection may occur at any time after the initial date of injury. Once the injured worker has sufficiently recovered, a Physical Capacity Evaluation and/or Functional Capacity Evaluation is usually performed to determine whether or not the injured worker is considered a candidate for a work hardening or work conditioning program. These tests are usually performed just prior to entry into the program and at the end of the program to determine the injured worker's level of physical ability and his capability to return to work. (g) Levels of Nonoperative Care. (1) Introduction. The following subsection defines the criteria for referral to primary, secondary and tertiary levels of care that are reasonable and necessary for care to the spine. Primary, secondary and tertiary levels of nonoperative care are illustrated in Tables I, II and III in paragraph (6) of this subsection. The tables define duration and specific components of each level of care. The clinical condition of the injured worker, as documented by the treating doctor, will be the determining factor for placing the injured worker in the most appropriate level of care. The injured worker may move between these levels of care dependent upon his condition and the treatment preceding the move between levels. The duration of treatment at any one level of care may be less than or greater than the recommended duration dependent upon the documented condition of the injured worker. If the treatment provided exceeds the recommended duration at that level of care, additional documentation needs to be provided regarding the need for extended care. Please note that treatment durations are considered cumulative and it should not always be necessary to use full durations for any given level of care (see subsection (e)(2)(G) of this section). (2) Primary Level of Care. This level of care is generally considered to be appropriate for injured workers immediately following the compensable injury; however, the injured worker in this level of care may also be an early postoperative patient or may be experiencing an acute exacerbation of his/her chronic back pain. Since bedrest and partial or total cessation of work over a brief period of time (i.e., 2 to 3 days maximum) is also considered to be part of the primary level of care, further treatment by a health care provider may not be considered necessary at this level of care. Little or no deconditioning has occurred due to the injury, immobilization or decreased activity. The goal for this level of care is symptom control to facilitate rapid recovery and return to work before deconditioning or psychosocial barriers occur. The usual duration for this level of care is eight weeks. (3) Secondary Level of Care. This level of care is the first stage of rehabilitation for those injured workers who have not returned to productivity through the normal healing process. It is designed to facilitate return to productivity before the onset of chronic disability. It is individualized, time limited and of limited intensity. The injured worker has a history of a limited- to-good response to early primary treatment with persistent symptoms limiting activities of daily living. The objective physical examination demonstrates findings suggestive of early deconditioning including loss of motion and/or strength with limitation of activities of daily living. Evidence of mental health or psychosocial barriers may be present which impede the injured worker's clinical progress. Duration of this level of care is generally up to eight weeks. In addition to the normative duration listed, an additional two weeks is added to secondary level for less intensive care if necessary at the termination of the tertiary level of care. Documentation of necessity must be included with the request for the additional two weeks. (4) Tertiary Level of Care. This level of care is interdisciplinary, individualized, and intensive, designed for the injured worker who demonstrates physical and psychological changes consistent with chronic disability. There is a documented history of persistent failure to respond to nonoperative or operative treatment which surpasses the usual healing period of four to six months post-injury or post-surgery or special cases with severe mental health issues lasting more than two months without response to primary or secondary treatment. Psychosocial issues such as substance abuse, affective disorders, and other psychological disorders may be present. There is a documented inhibition of physical functioning evidenced by pain sensitivity, and nonorganic signs such as fear which produce a physical inhibition or limited response to reactivation treatment. This level of care may also be indicated for the injured worker whose physical capacity to work still does not meet the job requirements for heavy physical labor after adequate treatment, thereby causing an inability to return to full duty. This situation would be evidenced by an excessive transitional period of light duty or significant episodes of lost work time due to the need for continued medical treatment. This level of care is also indicated for those injured workers who cannot tolerate either primary or secondary levels of care. The usual duration for this level of care is generally up to six weeks. (5) Criteria to Distinguish between Secondary and Tertiary Level of Care. Many factors may determine the choice between secondary and tertiary levels of care. In general, if lower cost secondary treatment can be effective, this level of care is preferred over the more expensive tertiary care. However, if the documented condition of the injured worker is indicative of the need for more intensive treatment, the tertiary level of care may be more appropriate. Key factors in determining the need for secondary versus tertiary care include: (A) the time elapsed since injury; (B) the presence of psychosocial barriers to recovery such as depression, substance abuse, personality disorder, etc., and the severity of these barriers; (C) the lack of responsiveness to previously attempted treatment; (D) the severity of physical/functional deconditioning; (E) socioeconomic barriers to recovery; and/or (F) failed back surgery. (6) Level of Care Tables. See Figures 4-7 published in the Tables and Graphics Section in this issue of the Texas Register. (A) Levels of Care Tables Figure 4: 28 TAC sec. 134.1001(g)(6)(A) (B) Table II. Secondary Level of Care Figure 5: 28 TAC sec. 134.1001(g)(6)(B) (C) Table III. Tertiary Level of Care Figure 6: 28 TAC sec.134.1001(g)(6)(C) (D) Table IV. Surgical Intervention Figure 7: 28 TAC sec. 134.1001(g)(6)(D) (h) Assessments/Evaluations (1) Interdisciplinary Assessment. In certain cases involving either surgical or nonoperative treatment, an interdisciplinary assessment may be needed. This assessment may include: (A) Sequelae of Injury. Injuries may produce a variety of unanticipated nonoperative or postoperative sequelae, including problems with other joints/regions due to deconditioning, chronic or progressive neurological conditions, urological problems, or a variety of mental health disturbances. Any or all of these may result in the need for an interdisciplinary assessment to determine what treatment options are needed to bring the injured worker to the highest functional level. (B) Intercurrent Illness. Injured workers suffering from a variety of intercurrent illnesses (e.g., hypertension, cardiac disease, diabetes, etc.) may require medical management beyond the scope of the treating doctor. An interdisciplinary assessment may be needed to determine the treatment options required to bring the injured worker to the highest functional level, given the limitations of the intercurrent illness. Treatment for the intercurrent illness may not be related to the compensable injury and therefore, may not be the responsibility of the workers' compensation insurance carrier. (C) Risk Factors for Complications. Some injured workers may have risk factors in their personal or family history which may affect the delivery of care. In particular, injured workers expecting to undergo surgery or to undergo an exercise program may demonstrate a variety of cardiovascular risk factors necessitating additional evaluations and modification to the treatment plan. (2) Physical Capacity and Functional Capacity Assessments. This paragraph specifically discusses the issues of physical and functional capacity assessments. These measurements have been used to monitor the injured workers's clinical progress; to guide the doctors and/or therapists in determining an exercise program and to provide objective data to determine a permanent physical impairment. (A) Physical Examination vs. Human Performance Measurement: A physical examination usually consists of a qualitative estimate of the injured worker's physical or functional ability. A human performance measurement, by contrast, involves the use of accurate devices and specific skills to quantitatively determine the performance parameters that provide an objective measurement of the injured worker's ability as it relates to the compensable injury. (B) A physical examination and neurological evaluation may include the following: (i) appearance: observation and palpation; (ii) flexibility (extremity joint or spinal region): usually observational; (iii) posture and deformities; (iv) vascular integrity; (v) dermatomal sensation: observational, to detect neurological sensory deficit; (vi) myotomal strength: usually observational, by manual muscle testing, to detect gross neurological motor deficits; and (vii) reflexes to detect neurological reflex asymmetry. (C) A physical capacity evaluation of the injured area may include the following: (i) range of motion: quantitative measurements (using appropriate devices) of the injured joint or region (i.e., knee, shoulder, lumbar spine, cervical spine, etc.); and (ii) strength/endurance: quantitative measures of the injured area or region using accurate devices (isometric, isoinertial and/or isokinetic devices in one or more planes), with comparison to contralateral side and/or normative database. (D) A functional capacity evaluation of the whole person or multiple areas of the body may include the following: (i) isometric lifting: NIOSH standard leg lift, torso lift, arm lift or extremity isometric test using measurement device; (ii) isokinetic lifting: controlled speed floor-to-knuckle, knuckle-to- shoulder lifts using measurement devices and standardized protocols; (iii) isoinertial lifting: standardized free weight lifting tests; (iv) activities of daily living tests: standardized tests (but often observational) of generic functional tasks (i.e. pushing, pulling, kneeling, squatting, carrying, climbing, etc.) (v) hand function tests: measurement of fine/gross motor coordination, grip strength, pinch strength, manipulation tests, etc., using measurement devices; (vi) submaximal cardiovascular endurance tests: measurement of aerobic capacity using bicycle or treadmill; and (vii) static positional tolerance: observational for tolerance of sitting or standing tolerance. (3) Appropriate and Inappropriate Testing. (A) Evaluations Appropriate to Level of Care. The actual need for diagnostic studies is dependent on both the amount of time that has passed since the date of injury and on the injured worker's documented clinical condition. To determine the level of testing appropriate for the injured worker, please refer to subsection (f) (relating to Diagnostic Procedures) of this section. (B) Inappropriate Testing. Certain tests and procedures are inappropriate for the assessment of work-related injuries. Some examples include tests performed only to assess the injured workers' efforts, physical capacity assessments for a joint or body region not related to the compensable injury or invalid or scientifically unjustifiable techniques. (i) Treatment Algorithms. Paragraphs (1)-(7) of this subsection present commonly pursued courses of treatment for spinal injuries depending on presenting conditions and associated factors. Algorithms are provided for progressive decisions relating to treatment approaches as well as commonly recognized treatment procedures.The treatment algorithms presented in this guideline offer greater potential for agreement between health care providers and payors on medical utilization for specific conditions than use of ICD-9 codes alone. Health care providers who pursue treatment at variance with the guideline are subject to greater documentation requirements as provided in subsection (e)(4) of this section. (1) Surgical Treatment Code Legend. See Figures 8 and 9 published in the Tables and Graphics Section of this issue of the Texas Register. Figures 8 and 9: 28 TAC sec.134.1001(i)(1) (2) Initial Approach to Treatment of Spinal Injury Chart 1. See Figure 10 published in the Tables and Graphics Section of this issue of the Texas Register . Figure 10: 28 TAC sec.134.1001(i)(2) (3) Fracture and/or Dislocation Chart 2. See Figure 11 published in the Tables and Graphics Section of this issue of the Texas Register. Figure 11: 28 TAC sec.134.1001(i)(3) (4) Soft Tissue Injury Chart 3. See Figure 12 published in the Tables and Graphics Section of this issue of the Texas Register. Figure 12: 28 TAC sec.134.1001(i)(4) (5) Peri-Operative Algorithm Chart 4. See Figure 13 published in the Tables and Graphics Section of this issue of the Texas Register. Figure 13: 28 TAC sec.134.1001(i)(5) (6) Surgical Treatment Chart 5. See Figure 14 published in the Tables and Graphics Section of this issue of the Texas Register. Figure 14: 28 TAC sec.134.1001(i)(6) (A) Surgical Treatment Subchart 5A. See Figure 15 published in the Tables and Graphics Section of this issue of the Texas Register. Figure 15: 28 TAC sec.134.1001(i)(6)(A) (B) Surgical Treatment Subchart 5B. See Figure 16 published in the Tables and Graphics Section of this issue of the Texas Register. Figure 16: 28 TAC sec.134.1001(i)(6)(B) (C) Surgical Treatment Subchart 5C. See Figure 17 published in the Tables and Graphics Section of this issue of the Texas Register. Figure 17: 28 TAC sec.134.1001(i)(6)(C) (7) Treatment Continuation Chart 6. See Figure 18 published in the Tables and Graphics Section of this issue of the Texas Register. Figure 18: 28 TAC sec.134.1001(i)(7) (j) Glossary. (1) Active Care vs. Passive Care. (A) Active care-modes of treatment or care requiring that the injured worker participate in and be responsible for the level of care received. (B) Passive care-modes of treatment or care which do not require the injured worker to participate in his/her care; i.e., the care is "done to" or "applied to" the injured worker (e.g., hot packs or cold packs) (2) Chronic Pain Management-a program which provides coordinated, goal- oriented, interdisciplinary team services to reduce pain, improve functioning, and decrease the dependence on the health care system of persons with chronic pain syndrome. (3) Clinical plateau-a period of time of relative stability in which the injured worker displays minimal or minor changes in his/her condition. (4) Clinical Progress vs. Lack of Clinical Progress. (A) Clinical progress-documented change in the condition of the injured worker, in response to the injured worker's current treatment program. (B) Lack of clinical progress-documented absence of change in the condition of the injured worker over a period of time of no less than one (1) month, requiring re- evaluation of the injured worker's condition and re-evaluation of the current treatment program. (5) Consulting doctor-a doctor who provides an opinion or advice regarding the evaluation and/or management of a specific problem, as requested by the treating doctor, the Commission, or the insurance carrier. A consulting doctor may only initiate diagnostic and/or therapeutic services with approval from the treating doctor. (6) Doctor-a doctor of medicine, osteopathic medicine, optometry, dentistry, podiatry, or chiropractic who is licensed and authorized to practice. (7) Health care facility-means a hospital, emergency clinic, outpatient clinic, or other facility providing health care. (8) Health care practitioner. (A) an individual who is licensed to provide or render and provides or renders health care; or (B) a nonlicensed individual who provides or renders health care under the direction or supervision of a doctor. (9) Health care provider-a health care facility or health care practitioner (10) Impairment-any anatomic or functional abnormality or loss existing after maximum medical improvement that results from a compensable injury and is reasonably presumed to be permanent. (11) Interdisciplinary programs-programs in which the delivery of services is provided by more than one type of health care service (e.g., occupational therapy, physical therapy, counseling services, medical services). Examples of this type of program include work hardening, outpatient medical rehabilitation, and chronic pain management. (12) Intervention-the act or fact of interfering with a condition to modify it or with a process to change its course (13) Level of service-refers to primary, secondary, or tertiary care. (14) Maximum Medical Improvement (MMI)-the earlier of the following two items: (A) the earliest date after which, based on reasonable medical probability, further material recovery from or lasting improvement to an injury can no longer reasonably be anticipated; or (B) the expiration of 104 weeks from the date on which income benefits begin to accrue. (15) Outpatient Medical Rehabilitation-a program of coordinated and integrated services, evaluation, and/or treatment with emphasis on improving the functional levels of the persons served. The program is interdisciplinary in nature and is applicable to those persons who have severe functional limitations of recent onset or recent regression or progression or those persons who have not had prior exposure to rehabilitation. Services may be directed toward the development and/or maintenance of the optimal level of functioning and community integration of the persons served. (16) Referral doctor-a consulting doctor who initiates health care treatments at the request of the treating doctor. (17) Self-referral-the direction of a patient to another doctor, institution or facility whereby the referring doctor has a financial or conflict of interest element. (18) Significant Neurological Deficit-rapidly progressing symptoms of increased physiological impairment such as severe weakness, bowel or bladder dysfunction directly related to the spinal injury, or severe sensory impairment. (19) Sprain-an injury to a ligament A. Mild (Grade 1)-only a few fibers are torn; ligament is mostly intact and the joint is stable; B. Moderate (Grade 2)- more fibers are torn, resulting in some instability with abnormal joint motion C. Severe (Grade 3)-ligaments are completely disrupted and instability may be severe (synonymous with marked). (20) Strain-an injury to a muscle A. Mild (Grade 1)-only a few fibers are torn; muscle is mostly intact and functional; B. Moderate (Grade 2) -more muscle fibers are torn resulting in muscle pain with contraction; C. Severe (Grade 3)- tendons are completely disrupted, extreme pain and loss of use of muscle. (21) Treating doctor-the doctor primarily responsible for coordinating the employee's health care for an injury. (synonymous with Primary Gatekeeper) (22) Treatment Duration-time allowed for treatment for a specific level of care. (23) Treatment plan-this is a written document which must contain the following components: A. type of intervention/treatment modality B. frequency of treatment; C. expected duration of treatment; D. expected clinical response to treatment; and E. specification of a re-evaluation timeframe. (24) Work Conditioning-a highly structured, goal-oriented, individualized treatment program using real or simulated work activities in conjunction with conditioning tasks. Work conditioning is a single disciplinary approach. (25) Work Hardening-a highly structured, goal-oriented, individualized treatment program designed to maximize the ability of the persons served to return to work. Work Hardening programs are interdisciplinary in nature with a capability of addressing the functional, physical, behavioral, and vocational needs of the injured worker. Work Hardening provides a transition between management of the initial injury and return to work while addressing the issues of productivity, safety, physical tolerances, and work behaviors. Work Hardening programs use real or simulated work activities in a relevant work environment in conjunction with physical conditioning tasks. These activities are used to progressively improve the biomechanical, neuromuscular, cardiovascular/metabolic, behavioral, attitudinal, and vocational functioning of the persons served. (k) Bibliography. (1) Barrows, G., Elton, D., Stanley, G.; PSYCHOLOGICAL CONTROL OF PAIN, Grune & Stratton, 1983 (2) Block, A.R.: Interdisciplinary treatment of chronic low back pain: A review. REHABIL PSYCHOL 1982: 27: 51-63. (3) Bonica, J.J. (1959). The management of pain. Philadelphia: Lea & Febiger. (4) Chaplin, E.R.(1991). Chronic pain: a sociobiological problem. In Walsh, N.E. (ed), Physical medicine and rehabilitation: State of the art reviews, 5(1), pp 1-47. Philadelphia, Henley & Belfus. (5) Davies G, Gould J: Trunk Testing Using a Prototype Cybex II Isokinetic Stabilization System. J Orthop Sports Phys Ther 3:164-170, 1982 (6) Deardorff, W.W., Rubin, H.S., Scott, D.W.: Comprehensive interdisciplinary treatment of chronic pain: a follow-up study of treated and non-treated groups. PAIN 1991: 45: 35-43. (7) Delitto A, Crandell C, Rose S: Peak Torque to Body Weight Ratios in the Trunk: A Critical Analysis. Phys Ther 69:138-143, 1989 (8) Doxey, N., Dzobia, R.D., Mitson, C.L., Lacroix, J.M.: Predictors of outcome in back surgery candidates. J Clin Psych 1988: 44: 661-622. (9) ECRI: "Spinal Cord (Dorsal Column) Stimulation for Chronic Intractable Pain", EXECUTIVE BRIEFINGS, December 1993. (10) Enders, P.L., The Value of Psychological Testing with Chronic Pain Patients. Evaluation and Treatment of Chronic Pain. Chapter 36, 589-595 (11) Flor, H., Fydrich, T., Turk, D.C.: Efficacy of interdisciplinary pain treatment centers: a meta-analytic review. PAIN 1992: 49: 221-230. (12) Fordyce W, Roberts A, Sternbach R: The Behavioral Management of Chronic Pain: A Response to Critics. Pain 22:112-125, 1985 (13) Frymoyer, John W., M.D., Editor: ORTHOPAEDIC KNOWLEDGE UPDATE 4 (HOME STUDY SYLLABUS), Harper & Row Publishers, 1987. (14) Gatchel R, Mayer T, Hazard R, Rainville J, Mooney V: Editorial: Functional Restoration: Pitfalls in Evaluating Efficacy. SPINE 17:988-995, 1992 (15) Genest, M., Meichenbaum, D., Turk, D.C.; PAIN & BEHAVIORAL MEDICINE (A COGNITIVE BEHAVIORAL PERSPECTIVE), Guilford Press, 1983 (16) Graves JE, Pollock M, Carpenter D, et al: Quantitative Assessment of Full Range-of-Motion Isometric Lumbar Extension Strength. SPINE 15:289-294, 1990 (17) Hazard R: Letter to the Editor. SPINE 16;1242-1243, 1991 (18) Hazard R, Fenwick J, Kalish S, Redmond J, Reeves G, Reid S, Frymoyer J: Functional Restoration With Behavioral Support: A One-Year Perspective Study of Chronic Low Back Pain Patients. SPINE 14:157-165, 1989 (19) Kanoff, Richard B., D.O., MSc (Neurosurg): "Intraspinal delivery of opiates by an implantable, programmable pump in patients with chronic, intractable pain of nonmalignant origin", JAOA, Vol. 94, No. 6, June 1994, pg 487-493. (20) Keeley J, Mayer T, Cox R, Gatchel R, Smith J, Mooney V: Quantification of Lumbar Function 5: Reliability of Range-of-Motion Measures in the Sagittal Plane and In Vivo Torso Rotation Measurement Techniques. SPINE 11:31-35, 1986 (21) Leavitt S, Johnston T, Beyer R: The Process of Recovery: Patterns in Industrial Back Injury: Part 1. Costs and Other Quantitative Measures of Effort. Industrial Medicine 40:7-14, 1971 (22) Loebl W: Measurements of Spinal Posture and Range in Spinal Movements. Ann Phys Med 9:103 1967 (23) Mayer T, Gatchel R: Functional Restoration for Spinal Disorders: The Sports Medicine Approach. Philadelphia, PA, Lea & Febiger, 1988 (24) Mayer T, Gatchel R, Kishino N, et. al.: Objective Assessment of Spine Function Following Industrial Injury: A Prospective Study With Comparison Group and One-Year Follow-Up: 1985 Volvo Award in Clinical Sciences. SPINE 10:482-493, 1985 (25) Mayer T, Gatchel R, Kishino N, et al: A Prospective Short-Term Study of Chronic Low Back Pain Patients Utilizing Novel Objective Functional Measurement. Pain 25:53-68, 1986 (26) Mayer T, Gatchel R, Mayer H, et al: A Prospective Two-Year Study of Functional Restoration in Industrial Low Back Injury: An Objective Assessment Procedure. JAMA 258-1763-1767, 1987 (27) Mayer T, Smith S, Keeley J, Mooney V: Quantification of Lumbar Function Part 2: Sagittal Plane Trunk Strength in Chronic Low Back Pain Patients. SPINE 10:765-772, 1985 (28) Mayer T, Smith S, Kondraske G, Gatchel R, Carmichael T, Mooney V: Quantification of Lumbar Function Part 3: Preliminary Data on Isokinetic Torso Rotation Testing with Myoelectric Spectral Analysis in Normal and Low Back Pain Subjects. SPINE 10:912-920, 1985 (29) Mayer T, Tencer A, Kristoferson S, Mooney V: Use of Noninvasive Techniques for Quantification of Spinal Range-of-Motion in Normal Subjects and Chronic Low-back Dysfunction Patients. SPINE 9:588-595, 1984 (30) Mellin G: Measurement of Thoracolumbar Posture and Mobility with Myrin Inclinometer. SPINE 11:759-762, 1986 (31) Nachemson A, LaRocca H: Editorial. SPINE 12:427-429, 1987 (32) North, Richard B: "The Role of Spinal Cord Stimulation in Contemporary Pain Management", APS JOURNAL, Vol. 2, No. 2, pg 91-99, 1993. (33) North, Richard B., M.D., et. al.: "Failed Back Surgery Syndrome: 5-Year Follow-Up after Spinal Cord Stimulator Implantation", NEUROSURGERY, Vol. 28, No. 5, 1991. (34) Oland G, Tveiten G: A Trial of Modern Rehabilitation for Chronic Low Back Pain and Disability: Vocational Outcome and Effect of Pain Modulation. SPINE 16:457-459, 1991 (35) Parnianpour M, Nordin M, Kahanovitz N, Frankel V: 1988 Volvo Award in Biomechanics: The Triaxial Coupling of Torque Generation of Movements on the Motor Output and Movement Patterns. SPINE 13:982-992, 1988 (36) Pollock M, Leggett S, Graves J, et al: Effect of Resistance Training on Lumbar Extension Strength. Am J Sports Med 17:624-630, 1989 (37) Reed, Presley: The Medical Disability Advisor, Second Edition; Horsham, PA: LPR Publications, 1994, 290, 473. (38) Sachs B, David J, Olimpio D, Scala A, Lacroix M: Spinal Rehabilitation by Work Tolerance Based on Objective Physical Capacity Assessment of Dysfunction: A Prospective Study with Control Subjects and 12-Month Review. SPINE 15:1325-1332, 1990 (39) Schwarts, D., Appropriate Referral to Inpatient vs Outpatient Pain Management Program: A Clinician's Guide, PAIN DIGEST, 1: 2-6, 1991 (40) Smidt G, Blantied P: Analysis of Strength Tests and Resistive Exercises Commonly Used for Low-Back Disorders. SPINE 12:1,025-1034, 1987 (41) Smith S, Mayer T, Gatchel R, Becker T: Quantification of Lumbar Function 1: Isometric and Multispeed Isokinetic Trunk Strength Measures in Sagittal and Axial Planes in Normal Subjects. SPINE 10:757-764, 1985 (42) Spengler, D.M., Ouellette, E.A., Battie, M., Zeh, J. (1991) Elective discectomy for herniation of a lumbar disc, THE JOURNAL OF BONE AND JOINT SURGERY, 72-A.2, 230-237. (43) Spitzer, Walter O., Chairman: SCIENTIFIC APPROACH TO THE ASSESSMENT AND MANAGEMENT OF ACTIVITY-RELATED SPINAL DISORDERS (A MONOGRAPH FOR CLINICIANS)(REPORT OF THE QUEBEC TASK FORCE ON SPINAL DISORDERS), Harper & Row Publishers, 1987. (44) State of Colorado, Department of Labor and Employment, Division of Workers' Compensation: LOW BACK PAIN TREATMENT GUIDELINES 1993. (45) State of Rhode Island Workers' Compensation Court Medical Advisory Board: PROTOCOLS. Volume 4, Edition 1. (46) Sullivan, M.J.L., Reesor, K., Mikail, S., Fisher, R., The Treatment of Depression in Chronic Low Back Pain: Review and Recommendations, PAIN, 50, 5-13, 1992 (47) Thorstensson A, Nilsson J: Trunk Muscle Strength During Constant and Velocity Movement. Scand J Rehab Med 14:61-68, 1982 (48) Turner, R.S., Leiding, W.C. (1985). Correlation of the MMPI with lumbosacral spine fusion results prospective study. SPINE, 10.10, 932-936. (49) U.S. Department of Health and Human Services: ACUTE LOW BACK PROBLEMS IN ADULTS (CLINICAL PRACTICE GUIDELINE. NUMBER 14). (50) Ward, N.G., Bloom, V.L., Friedel, R.O. (1979). The effectiveness of tricyclic antidepressants in the treatment of coexisting pain and depression. PAIN, 7, 331-341. This agency hereby certifies that the rule as adopted has been reviewed by legal counsel and found to be a valid exercise of the agency's authority. Issued in Austin, Texas, on March 20, 1995. TRD-9503464 Susan Cory General Counsel Texas Workers' Compensation Commission Effective date: June 1, 1995 Proposal publication date: September 20, 1994 For further information, please call: (512) 440-3700 TITLE 40. SOCIAL SERVICES AND ASSISTANCE Part I. Texas Department of Human Services Chapter 94. Nurse Aides The Texas Department of Human Services (DHS) adopts amendments to its Chapter 94, Nurse Aides, sec.sec.94.2, 94.5-94.9, and 94.11, concerning definitions; competency evaluation program requirements; program director and skills examiner requirements; filing and processing an application for a nurse aide training and competency evaluation program (NATCEP), or skills examiner; approval, reapproval, and inspection of a NATCEP; withdrawal of approval of a NATCEP, and skills examiner; and registry, findings, inquiries; and adopts the repeal of and new sec.94.13, concerning requirements for criminal conviction checks of nurse aides. Sections 94.7, 94.9, and 94.11 are adopted with changes to the proposed text as published in the September 27, 1994, issue of the Texas Register (19 TexReg 7589). The amendments to sec.sec.94.2, 94.5, 94.6, and 94.8, and the repeal of and new sec.94.13 are adopted without changes to the proposed text, and will not be republished. The justification for the amendments, repeal, and new section is to update and strengthen these regulations as well as to ensure continued compliance with the mandates of the Omnibus Budget Reconciliation Act of 1987 (OBRA '87) which forms the foundation of the NATCEP as operated by DHS. The amendments, repeal, and new section will function by providing updated rules concerning the regulation of NATCEPs and nurse aides. During the public comment period, DHS received comments from the Texas Health Care Association. A summary of the comments and DHS's responses follow. Comment: An eligible individual should be allowed to challenge free-standing competency evaluation programs (CEPs) twice rather than once as stated in sec.94.5(c)(1)(D)(4). Sometimes an individual, who has demonstrated skills, performs poorly on the free-standing CEP because of stage fright or feelings of being unsure. Response: DHS believes that allowing an eligible individual to challenge the free-standing CEP once is appropriate. If an individual fails the free-standing CEP, the individual must have the benefit of participating in a nurse aide training program in order to strengthen the knowledge and skills required to become a certified nurse aide. After participating in a nurse aide training program, the individual will have three opportunities to pass the CEP. Comment: The function of skills examiner should not be performed by DHS staff as stated in the proposed amendment to sec.94.6(c). Before this type of change is even considered by DHS, tremendous work is needed on how this will be implemented and how it will be carried out. Response: Title 42, Code of Federal Regulations, sec.483.154(c)(i) gives states the authority to directly administer the competency examination and evaluation or approve an entity to provide this service. The proposed language in sec.94.6(c) complies with the federal regulations. Comment: In sec.94.7(c), the time period during which DHS provides notice of approval or proposed disapproval of a NATCEP application or skills examiner or requests additional information on a NATCEP application or skills examiner should not be increased from 30 to 60 days. Response: Title 42, Code of Federal Regulations, sec.483.152(c) requires states to provide notice within 90 days regarding the approval or disapproval of a NATCEP application or skills examiner or a request for additional information. A 90-day window provides DHS additional time for processing an application, if necessary. Comment: In sec.94.7(e), the time period during which a written appeal may be filed regarding a proposed disapproval of a NATCEP or skills examiner should not be decreased from 20 to 10 days. In addition, this 20-day period should begin upon the receipt of the proposed disapproval notice. Response: DHS agrees and will lengthen the time period for filing written appeals to 20 days after receiving the disapproval notice. Although sec.79.1605 of this title (relating to Request for a Hearing) provides 15 days for filing an appeal, DHS has added five days for mailing the appeal and internal routing at DHS. Comment: Revise sec.94.9(e) so that the period of time for initiating a written appeal regarding DHS's withdrawing approval of a NATCEP or skills examiner begins with the date on which the withdrawal notice is personally delivered. Response: DHS is revising sec.94.9(e) to state that the period of time for initiating a written appeal of a withdrawal notice will begin with the receipt of the withdrawal notice in accordance with sec.79.1605 of this title (relating to Request for a Hearing). In addition, to maintain consistency with the changes to sec.94.7(e), the time period for filing a written appeal has been increased to 20 days. Comment: There is no need for both the facility and the nurse aide to submit documentation to DHS to verify the current employment status of a nurse aide, as stated in sec.94.11(b)(1) and (2). Response: DHS agrees with this recommendation and is adopting sec.94.11(b)(2) with changes to state that nurse aides must submit employment documentation to DHS unless the nurse aides know this was done by the facilities where they were employed. In addition to changes resulting from comments, DHS is making technical changes to correct several inaccuracies. In the definition of nurse aide in sec.94.2, the federal reference has been changed to Code of Federal Regulations (CFR), Chapter 42, sec.sec.483.151-483.154. In sec.94.7(e), the reference for the hearing process has been changed to Title 40, Texas Administrative Code (TAC), sec. sec.79.1601-79.1614. Section 94.9(e) has been corrected to state that an administrative law judge conducts an appeal hearing for the withdrawal of approval of a NATCEP or skills examiner. A change has been made to sec.94.11(c) to indicate that written requests for a hearing on allegations of abuse, neglect, or misappropriation of property by a nurse aide must be made within 20 days of the date the notice is mailed, in order to be consistent with the informal hearing rules at 40 TAC sec.sec.79.1001-79.1007. 40 TAC sec.sec.94.2, 94.5-94.9, 94.11 The amendments are adopted under the Human Resources Code, Title 2, Chapters 22 and 32; the Health and Safety Code, Chapter 250; and Texas Civil Statutes, Article 4413 (502), sec.16. The Human Resources Code, Chapters 22 and 32, provide the department with the authority to administer public and medical assistance programs. The Health and Safety Code, Chapter 250, provides the department with the authority to administer the nurse aide program and registry. Texas Civil Statutes, Article 4413(502), sec.16, provides the Health and Human Services Commission with the authority to administer medical assistance funds. The amendments implement the Human Resources Code, sec. sec.32.001-32.042, and the Health and Safety Code, Chapter 250, sec.sec.250.001-250.009. sec.94.7. Filing and Processing an Application for a Nurse Aide Training and Competency Evaluation Program, or Skills Examiner. (a) (No change.) (b) The Texas Department of Human Services (department) will consider whether the applicant complies with the Omnibus Budget Reconciliation Act of 1987 (Act) and this chapter. (c) Notice of approval or proposed disapproval of the application or request for additional information will be given to the applicant within 90 days of the receipt of a complete application. If the application is proposed to be disapproved due to noncompliance with the requirements of the Act or this chapter, the reason for disapproval must be given in the notice. (d) The applicant will be notified in writing of any deficiencies found in the complete application and given an opportunity to demonstrate compliance with provisions of the Act and this chapter by written response within 10 days of receipt. (e) An applicant for approval of a nurse aide training and competency evaluation program (NATCEP) or skills examiner may request a hearing on a proposed disapproval. Such request must be made, in writing, within 20 days of the date the notice is received by the applicant. Such hearing will be held pursuant to the applicable provisions of the department's formal hearing procedures as provided in sec.sec.79.1601-79.1614 of this title (relating to Formal Hearings). The final hearing decision will be made as provided in this subsection. The administrative law judge, upon completion of the hearing, must prepare a written decision based solely on the evidence presented at the hearing and the statutory and regulatory provisions of the Act and this chapter. The decision must state the reasons for the decision. (1)-(2) (No change.) sec.94.9. Withdrawal of Approval of a Nurse Aide Training and Competency Evaluation Program, and Skills Examiner. (a) Approval of a nurse aide training and competency evaluation program (NATCEP), or skills examiner may be withdrawn for any violation of or noncompliance with the Omnibus Budget Reconciliation Act of 1987 or this chapter. (b)-(c) (No change.) (d) If the department proposes to withdraw approval of a NATCEP, or skills examiner, the department must notify the NATCEP, or skills examiner by mail at the last known address as shown in the department's records or by personal delivery. The notice must state the facts or conduct alleged to warrant the action and state that the individual has an opportunity to request in writing a hearing. (e) The NATCEP or individual notified may request a hearing. A request for a hearing must be made, in writing, within 20 days of the date the notice is received by the NATCEP or individual. Such hearing will be held pursuant to the applicable provisions of the department's formal hearing procedures as provided in sec.sec.79.1601-79.1614 of this title (relating to Formal Hearings). The final hearing decision will be made as provided in this subsection. The administrative law judge, upon completion of the hearing, must prepare a written decision based solely on the evidence presented at the hearing and the statutory and regulatory provisions of the Act and this chapter. The decision must state the reasons for the decision. (1)-(2) (No change.) (f) (No change.) sec.94.11. Registry; Findings; Inquiries. (a) (No change.) (b) Nurse aide certification expires 24 months after being added to the Nurse Aide Registry or after the last date of verified employment. The department will remove a Nurse Aide Registry entry for which appropriate employment verification has not been received prior to the expiration date, unless a finding of abuse, neglect, or misappropriation of resident property is on the registry for that individual. To maintain current Nurse Aide Registry status, the following requirements must be met: (1) Facilities must submit a department form to the department annually to document all nurse aides who are performing or have performed paid nursing or nursing-related services at the facility during the past year. (2) A nurse aide must submit a department form to the department prior to the expiration of his certification to document that the nurse aide has performed paid nursing or nursing-related services, unless the aide knows documentation was submitted by the facility or facilities at which he was employed. (c) The department reviews and investigates allegations of abuse, neglect, or misappropriation of resident property by a nurse aide. A nurse aide must be given written notice by the department of a proposed finding on an allegation and may request a hearing. The request must be made, in writing, within 20 days of the date the notice is mailed to the nurse aide. The hearing is held pursuant to the applicable provisions of the department's informal hearing procedures as provided in sec.sec.79.1001-79.1007 of this title (relating to Informal Hearings). The final hearing decision is made as provided in paragraph (3) of this subsection. (1) A copy of the department's investigative report concerning the incident which is the subject of the hearing must be provided prior to the hearing by the hearing coordinator to the nurse aide, upon written request by the nurse aide. Such report may be used in the preparation of the nurse aide's defense, but is otherwise confidential in accordance with Health and Safety Code, Chapter 242, Section 127, and no other use and no subsequent release is authorized. (2) (No change.) (3) The hearing officer, upon completion of the hearing, must prepare a written decision based solely on the evidence presented at the hearing and the statutory and regulatory provisions of the Omnibus Budget Reconciliation Act of 1987 and this chapter. The decision must state the reasons for the decision. (d) If an alleged act of abuse, neglect, or misappropriation by a certified nurse aide, who also is a permitted medication aide under Chapter 95 of this title (relating to Medication Aides), violates the rules in this chapter and Chapter 95 of this title, the nurse aide's request for an appeal of the department's finding on abuse, neglect, and/or misappropriation must be conducted through the department's formal hearing procedures under sec. sec.79. 1601-79.1612 of this title (relating to Formal Appeals) and the Administrative Procedures Act, Title 10 of the Texas Government Code, sec.sec.2001.051 et seq. Through the formal hearing, determinations are made on both the certificate of nurse aide practice and the permit for medication aide practice. (e) The department must not make a finding that an individual has neglected a resident if the individual demonstrates that the neglect was caused by factors beyond the individual's control. (f) The registry, the nurse aide, and the administrator of the facility where the event occurred must be notified of the findings. (g) The registry must include the documented findings involving an individual listed on the registry, as well as any brief statement of the individual disputing the findings. (h) The information on the registry must be made available to the public. (i) The department, in the case of inquiries to the registry, must verify if the individual is listed on the registry and must disclose any information concerning a finding of neglect, abuse or misappropriation of resident property involving an individual listed on the registry. It must also disclose any statement by the individual related to the finding or a clear and accurate summary of such a statement. This agency hereby certifies that the rule as adopted has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority. Issued in Austin, Texas, on March 21, 1995. TRD-9503479 Nancy Murphy Section Manager, Media and Policy Services Texas Department of Human Services Effective date: May 1, 1995 Proposal publication date: September 27, 1994 For further information, please call: (512) 450-3734 40 TAC sec.94.13 The repeal is adopted under the Human Resources Code, Title 2, Chapters 22 and 32; the Health and Safety Code, Chapter 250; and Texas Civil Statutes, Article 4413 (502), sec.16. The Human Resources Code, Chapters 22 and 32, provide the department with the authority to administer public and medical assistance programs. The Health and Safety Code, Chapter 250, provides the department with the authority to administer the nurse aide program and registry. Texas Civil Statutes, Article 4413(502), sec.16, provides the Health and Human Services Commission with the authority to administer medical assistance funds. The repeal implements the Human Resources Code, sec.sec.32.001-32.042, and the Health and Safety Code, Chapter 250, sec.sec.250.001-250.009. This agency hereby certifies that the rule as adopted has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority. Issued in Austin, Texas, on March 21, 1995. TRD-9503488 Nancy Murphy Section Manager, Media and Policy Services Texas Department of Human Services Effective date: May 1, 1995 Proposal publication date: September 27, 1994 For further information, please call: (512) 450-3765 The new section is adopted under the Human Resources Code, Title 2, Chapters 22 and 32; the Health and Safety Code, Chapter 250; and Texas Civil Statutes, Article 4413 (502), sec.16. The Human Resources Code, Chapters 22 and 32, provide the department with the authority to administer public and medical assistance programs. The Health and Safety Code, Chapter 250, provides the department with the authority to administer the nurse aide program and registry. Texas Civil Statutes, Article 4413(502), sec.16, provides the Health and Human Services Commission with the authority to administer medical assistance funds. The new section implements the Human Resources Code, sec. sec.32.001-32.042, and the Health and Safety Code, Chapter 250, sec.sec.250.001-250.009. This agency hereby certifies that the rule as adopted has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority. Issued in Austin, Texas, on March 21, 1995. TRD-9503487 Nancy Murphy Section Manager, Media and Policy Services Texas Department of Human Services Effective date: May 1, 1995 Proposal publication date: September 27, 1994 For further information, please call: (512) 450-3765 Texas Department of Insurance Exempt Filing Notification Pursuant to the Insurance Code, Chapter 5, Subchapter L (Editor's Note: As required by the Insurance Code, Article 5.96 and 5. 97, the Texas Register publishes notices of actions taken by the Department of Insurance pursuant to Chapter 5, Subchapter L, of the Code. Board action taken under these articles is not subject to the Administrative Procedure Act. These actions become effective 15 days after the date of publication or on a later specified date. The text of the material being adopted will not be published, but may be examined in the offices of the Department of Insurance, 333 Guadalupe, Austin.) The Commissioner of Insurance, at a public hearing under Docket Number 2140 held at 1:00 p.m., March 20, 1995 in Room 100 of the Texas Department of Insurance Building, 333 Guadalupe Street in Austin, Texas, adopted amendments proposed by the Texas Automobile Insurance Service Office (TAISO) to the Texas Automobile Rules and Rating Manual (the Manual). TAISO's petition (Reference Number A-1294-30) was published in the February 17, 1995, issue of the Texas Register (20 TexReg 1137). Amendments are adopted to the following in the rule portion of the Manual: Rules 6, 13, 15, 26, 42, 49, 73, 74, 75, and 135. None of the changes are substantive, and many of them merely change the current wording, Texas Automobile Insurance Plan to Texas Automobile Insurance Plan Association in conformity with the Insurance Code, Article 21.81. Amendments are also adopted to the following in the rate portion of the Manual: Rules 24, 129, 134, and 135. These changes are also non-substantive. Current Endorsement 544B is to be redesignated 544C, and is to be renamed, Texas Automobile Insurance Plan Association. There are no substantive amendments adopted, and the changes other than those concerning the new name of the Texas Automobile Insurance Plan Association are described in the following five paragraphs. The change to Section VII-Rule 135 adds the phrase rates -Refer to Rate Section VII to the end of this rule's Section II, subsection H. This change directs users to the proper section for rating information relating to optional inflation coverage. The change is necessary to add uniformity to this section of the Manual and to clarify that Rate Section VII applies to subsection H as well as subsections F, G, and I. The changes to Rate Section II-Rule 24 redesignate Section B, paragraphs 1., 2., and 3. relating to Liability Coverages as Section B, paragraphs 2., 3., and 4. respectively. Section C relating to Premium Computation is also redesignated as Section B, paragraph 6. The changes are necessary to make the rating provisions correspond with the classification and numerical system utilized in Section II-Rule 24 of the Manual. The change to Rate Section VII-Rule 129 deletes the separate reference to Section B, paragraph 1.b. relating to medical payments and personal injury protection. The substance of the provision remains without specific identification. The change is necessary to make the rating provision correspond with the classification currently found in Section VII-Rule 129 of the Manual. This change further adds uniformity to the related provision and prevents unnecessary confusion. The change to Rate Section VII-Rule 134 deletes the parentheses from Section D, paragraphs 5.b. and c. This change is merely an editorial correction. The change to Rate Section VII-Rule 135 capitalizes the s in the word specified in the chart outlined in this rule's Section I, paragraph C.5. This change is merely an editorial correction. The amendments as adopted by the Commissioner of Insurance are shown in exhibits on file with the Chief Clerk under Reference Number A-1294-30, which are incorporated by reference into Commissioner's Order Number 95-0255. The Commissioner of Insurance has jurisdiction over this matter pursuant to the Insurance Code, Articles 5.06, 5.96, 5.98, and 5.101. The notification is made pursuant to the Insurance Code, Article 5.96, which exempts it from the requirements of the Government Code. Consistent with the Texas Insurance Code, Article 5.96(h), the Department will notify all insurers writing automobile insurance of this adoption by letter summarizing the Commissioner's action. IT IS THEREFORE THE ORDER of the Commissioner of Insurance that the Texas Automobile Rules and Rating Manual is amended as described herein, and the amendments are adopted to become effective June 1, 1995. This agency hereby certifies that the proposal has been reviewed by legal counsel and found to be within the agency's authority to adopt. Issued in Austin, Texas, on March 21, 1995. TRD-9503491 Alicia M. Fechtel General Counsel and Chief Clerk Texas Department of Insurance Effective date: June 1, 1995 Proposal publication date: February 17, 1995 For further information, please call: (512) 463-6327