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 22. EXAMINING BOARDS PART XI. Board of Nurse Examiners CHAPTER 215.Nurse Education 22 TAC sec.215.15 The Board of Nurse Examiners adopts amendments to sec.215.15 concerning Students with changes to the proposed text as published in the October 17, 1997, issue of the Texas Register (22 TexReg 10233). The change deletes the phrase "accepted for enrollment or" to require the rule to apply only to those students already enrolled in the nursing program. The amendments are being adopted to implement Senate Bill 617 which became effective September 1, 1997. The statutory change allows the Board to require schools of nursing to ensure that individuals enrolled in nursing programs in Texas are informed of eligibility criteria and potential bars to licensure. The adopted amendments will implement Senate Bill 617 in a manner that provides flexibility for the nursing programs, minimizes reporting requirements to the Board, and maintains a record that enrollees have been informed of eligibility issues and the Declaratory Order Process. Unless requested by the Board, documents will be maintained with student files or in a manner to be determined by the nursing programs. The proposed amendments were shared with deans and directors of nursing programs during their annual meeting in September, 1997. At that meeting, the deans and directors voiced concerns regarding verbally informing individuals accepted for enrollment about the eligibility issues, rather than only those enrolled. In addition, clarification was requested regarding which nursing programs would be required to inform enrollees about eligibility issues since students enrolled in RN-BSN completion programs or tracks are already RNs and do not need notification of the requirement. Lastly, they were concerned about developing their own form and suggested that an official Board form be created. A written comment was received from Texas Woman's University, stating that the term "individuals accepted for enrollment" was cumbersome and probably impossible to implement. The Board agreed with the comments and modified the rule accordingly. The amendments are 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 and Article 4519a, sec.1, which states that an individual enrolled or planning to enroll in an educational program that prepares an individual for an initial license as a registered nurse who has reason to believe that the individual is ineligible for the license may petition the board for a declaratory order as to the individual's eligibility. There are no other rules, codes, or statutes that will be affected by this proposal. Education sec.215 sec.215.15.Students. (a)-(e) (No change.) (f) Individuals enrolled in accredited professional nursing programs preparing students for initial licensure shall be provided verbal and written information regarding conditions that may disqualify graduates from licensure and of their rights to petition the Board for a Declaratory Order of Eligibility. (1) Required eligibility information includes: (A) Texas Civil Statutes, Articles 4519a and 4525; (B) Rules 213.27-213.30 of this Chapter (relating to Good Professional Character, Licensure of Persons with Criminal Convictions, Eligibility and Disciplinary Criteria Regarding Intemperate Use and Lack of Fitness and Declaratory Order of Eligibility for Licensure; and (C) Declaratory Order Petition Request Form. (2) Written receipt of the required information shall be documented on the Licensure Eligibility Form which contains, at a minimum, the following board approved elements: (A) name, date of birth, and social security number of the individual enrolled in the accredited professional nursing program; (B) statement that the information cited in sec.215.15(f)(1) of this section (relating to Students) was received and explained; and (C) signature of the individual who received the information and date of receipt. (3) Records documenting the receipt of the required information shall be maintained by the nursing program until six months after the individual enrolled completes the nursing program or permanently withdraws from the nursing program. (4) The Director of the Nursing Program shall submit an affidavit each year with the Annual Report that all individuals enrolled in the accredited nursing program received the required eligibility information, that it was explained to the students, and that the forms documenting that receipt were signed and maintained by the nursing program. This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority. Issued in Austin, Texas, on November 25, 1997. TRD-9715899 Katherine A. Thomas, MN, RN Executive Director Board of Nurse Examiners Effective date: January 1, 1998 Proposal publication date: October 17, 1997 For further information, please call: (512) 305-6811 TITLE 28. INSURANCE PART I. Texas Department of Insurance CHAPTER 19. Agents Licensing SUBCHAPTER R. Utilization Review Agents 28 TAC sec.sec.19.1702-19.1721 The Commissioner of Insurance adopts amendments to Chapter 19, concerning utilization review agents, by amending sec.sec.19.1702-19.1719 and adding new sec.sec.19.1720 and 19.1721. Amendments to sec.sec.19.1702, 19.1704, 19.1705, 19.1710, 19.1712 - 19.1714, 19.1716, 19.1719 and new sec.19.1721 are adopted with changes to the proposed text as published in the September 5, 1997 issue of the Texas Register (22 TexReg 8863). Sections 19.1703, 19.1706, 19.1707, 19.1708, 19.1709, 19.1711, 19.1715, 19.1717, 19.1718, and 19.1720 are adopted without changes and will not be republished. These amendments are necessary to implement provisions of the Insurance Code Article 21.58A, amended by Senate Bills 384 and 386, enacted by Acts, 75th Legislature, 1997, and codified at Texas Insurance Code Article 21.58A, effective September 1, 1997, relating to health care utilization review agents and independent review of adverse determinations. In addition, the amendments are necessary to promote the consistent delivery of quality health care in a cost-effective manner by requiring utilization review agents to adhere to such standards when conducting reviews. The amendments are necessary to ensure an efficient and effective appeals process for the review of utilization review decisions. The new sections establish specialty review utilization review agents and requirements for their licensing, and set forth the obligations of utilization review agents regarding requests for independent review by independent review organizations. The sections provide clarification concerning utilization review agent's licensure and renewal and reporting requirements of utilization review agents. After receiving public comments on the proposed amendments to Chapter 19, the department has made the following changes. Based on comments, the department has deleted language in sec.19.1702(b) to clarify licensing requirements for an insurer or HMO. Consistent with these changes, the department has also changed sec.19.1719(a)(3) and (b)(4) to clarify the information that is to be submitted by insurers and HMOs which must register with the department. Based on comments, the department has deleted language in sec.19.1702(c) which stated, "This subchapter does not affect the authority of the Texas Workers' Compensation Commission to exercise the powers granted to that commission under Title 5, Labor Code," and has renumbered prior subsection (d) as (c). It has also added language to sec.19.1702(c)(3)(C) stating that the subchapter does not apply to reviews of health care services provided to patients under the authority of the Texas Workers' Compensation Act. These recommended changes were made pursuant to House Bill 3197, 75th Texas Legislature, which amended Article 21.58A to require regulation of utilization review of a medical benefit under the workers' compensation act, but which states it does not affect the authority of the Texas Workers' Compensation Commission (TWCC) to exercise the powers granted under its statute, which prevails in the event of a conflict. However, the department has determined that these rules will not apply to utilization review of workers' compensation benefits, and that instead it will, in cooperation with TWCC, propose rules specific to workers' compensation utilization review. Those rules will specify which provisions of Article 21.58A apply to such review, and which are in conflict with the workers' compensation act and therefore subject to the latter statute. Changes were made in response to comments on sec.19.1704(c)(12) and (d) to clarify that biographical data on each person conducting utilization review, such as physicians or nurses, is not necessary. For purposes of consistency with these changes, sec.sec.19.1704(c)(6) and 19.1706(c) were changed to require applicants for certification to submit the names of personnel employed or contracted to perform utilization review. New subsection (i) has been added to sec.19.1704, in response to a comment, to provide that utilization review agents that were certified prior to the adoption of these rules must file with the department all changes to their original applications necessitated by these rules by March 1, 1998. In addition, pursuant to a comment the department has clarified the meaning of "special circumstances" in sec.19.1705(2)(A), and has eliminated reference to "complex conditions," which it believes are encompassed within the scope of special circumstances. Clarifying language was added to sec.sec.19.1705(2)(H)(iv), 19.1712(b)(2) and (5) and 19.1713(c), in response to comments; other clarifying language was added to sec.sec.19.1705(4) and 19.1721(c). Typographical errors were corrected in sec.sec.19.1710(b) and 19.1716(b)(7). New subsection (c)(5) was added to sec.19.1710 to clarify what must be included in the notice of adverse determination. In response to a comment, sec.sec.19.1710(e) and 19.1721(a) were changed to clarify that notification must be provided to an enrollee or person acting on the enrollee's behalf. Pursuant to comment, sec.19.1714(b) was changed to specify that personal information, for purposes of confidentiality, shall include at a minimum a person's name, address, phone number, social security number, and financial information. In sec.19.1716(b)(6), the requirement was deleted that a utilization review agent provide to the department certain information concerning referrals to independent review organizations, and paragraph (7) was renumbered accordingly. Section 19.1719(a)(3) added language in response to comments and subsection(b)(4) was changed to be consistent with (a)(3). Section 19.1721(c) was changed to clarify that a utilization review agent shall permit any party whose appeal is denied by the utilization review agent to seek review of the determination by an independent review organization. Section 19.1702(b) establishes the applicability of the Act to licensed HMOs. Section 19.1703 amends the definitions of "administrative procedure act," "appeal process," "complaint," "inquiry," "life-threatening," and "practicing healthcare provider" to clarify the meaning of the amendments. The section also redefines "emergency care," "open records law," and "provider of record" to make this section consistent with the amendments. Section 19.1704 establishes a new address where applications for utilization review licensing must be submitted, requires that certain screening criteria requirements comply with the Act and the absence of certain compensation arrangements be certified by an authorized representative of the company, requires establishment of procedures for handling both oral and written complaints by enrollees, patients, or health care providers, specifies that samples of utilization review materials submitted with applications must include language for notification of an adverse determination made in a utilization review, sets forth specific documentation to be submitted with all applications for utilization review licensure, and defines "material changes" for reporting purposes. Amendments to this section also clarify the timeframes in which the department must respond to applications and the timeframes and requirements for application of renewal by the utilization review agent. Section 19.1705, as amended, requires that practicing physicians and health care providers have input into the development of a utilization review plan and that the plan include written procedures for identification of individuals with special circumstances who may require flexibility in the application of screening criteria. This section requires prior written notice to a physician or health care provider when publishing certain data which identifies a particular physician or health care provider. This section also sets forth certain criteria for utilization review decisions, and requires referral to an appropriate "dentist" or "health care provider" performing utilization review under certain circumstances. Amendments to this section also provide that delegation of review to a hospital utilization review program does not relieve the utilization review agent of full responsibility for compliance with this subchapter. Amendments to sec.19.1706 specify which information obtained from a physician, dentist or health care provider, must be obtained by specifically qualified personnel. Amendments to this section also provide that a physician directing utilization review for a utilization review agent may be employed by or under contract to the utilization review agent. A new subsection (f) added to sec.19.1708 prohibits a utilization review agent's observation of a psychotherapy session or access to mental health therapists' process or progress notes, although it specifically does not preclude the agent from requiring submission of the patient's medical record. Amendments to sec.19.1710 require that a notification of adverse determination by a utilization review agent include the clinical basis for the determination and information concerning the independent review process. The amendments also provide that telephonic or electronic transmissions of notice where the patient is hospitalized be followed by a letter within three working days, that notice denying post-stabilization care subsequent to emergency treatment be given within the time appropriate to the circumstances, for life-threatening conditions, the timeframes for notice set forth in subsection (d) of this section apply. Amendments to sec.19.1712 provide that an adverse determination may be appealed orally or in writing, and require the utilization review agent to acknowledge receipt of the appeal within five days. Amendments to this section also provide that dentists may, when appropriate, make appeal decisions, and also impose a period of 15 working days for completion of specialty review. These amendments, additionally, require that the utilization review agent maintain a method of expedited appeal for denials of care in life-threatening conditions, and require that utilization review agents issue response letters to patients explaining the resolution of the appeals. Amendments to this section also provide that in circumstances involving a life-threatening condition, there may be an immediate appeal to an independent review organization. Amendments to sec.19.1713 require a utilization review agent to provide to the commissioner a written description of procedures for responding to requests for post-stabilization care subsequent to emergency treatment. Amendments to sec.19.1714 require that authorization for release of confidential information submitted by anyone other than the individual who is the subject of the information requested must contain the signature of such individual and be dated within the past year. The amendments also set forth requirements of a utilization review agent in responding to such requests, and permissible charges therefor. Finally, the amendments maintain that the commissioner is entitled to such information from the utilization review agent upon request. An explanation of what constitutes minimum personal information was also included. Amendments to sec.19.1716 add the requirements that the utilization review agent's summary report of written complaints must include the total number of written notices of adverse determinations, and set forth the specific requirements for listing appeals of adverse determinations in the summary report and the classifications of appellants. The amendments also require utilization review agents to respond to complaints within 30 days of their receipt and require the maintenance of records for three years from the time complaints are filed. Section 19.1717, as amended, includes the HMO or insurer as parties which shall be notified by the commissioner or the commissioner's designated representative of any alleged violations of the Act, and allows the commissioner to assess administrative penalties under the Insurance Code Article 1.10E. Section 19.1719, as amended, requires HMOs and insurers performing utilization review under Section 14(g) and (h) of the Act to register with the department. It also sets forth the specific portions of this subchapter to which HMOs and insurers performing utilization review under the Insurance Code Article 21.58A, sec.14(g) and (h) will be subject, and requires that they submit written documentation to the department demonstrating compliance with all filing requirements required of utilization review agents. The amendments also include HMOs that contract with the Health and Human Services Commission or any agency operating part of the state Medicaid managed care program. The amendments also subject HMOs and insurers performing utilization review under the Insurance Code Article 21.58A, sec.14(g) and (h) to assessment of maintenance taxes under the Insurance Code. Section 19.1720 establishes specialty utilization review agents and sets forth the requirements for their licensure, and standards for specialty review. Section 19.1721 sets forth the obligations of utilization review agents for requesting and facilitating independent review by an independent review organization when requested. sec.19.1702(b). One commenter suggested that the rules clarify at the beginning of this section whether a Health Maintenance Organization (HMO) must obtain a license as a utilization review agent. Response. The department agrees and has added clarifying language in sec.19.1702(b) requiring the filing of documentation with the department to assure compliance with the Act as set forth in sec.19.1719. The department has made changes to clarify that the name, address, contact name, phone number and utilization review plan of the health maintenance organization is to be submitted. sec.sec.19.1702(c), 19.1705 and 19.1719(b)(1). Several commenters suggested that there may be possible conflicts between the Labor Code, Title 5, the Texas Workers' Compensation Commission rules, and these proposed sections. One commenter asked if the spinal surgery second opinion process, as outlined in the Texas Labor Code and Texas Workers' Compensation Commission rules conflicts with the proposed Chapter 19 rules. A commenter questioned whether the Texas Workers' Compensation Commission medical dispute resolution process conflicts with TDI provisions governing appeals and/or written procedures. Some commentors suggested that the deletion of the language excluding workers' compensation from the scope of the rules either be postponed until such time as rules for workers' compensation may be adopted or that language be added to clarify that the utilization review rules are not applicable to workers' compensation until additional rules are adopted. The commentors stated that the inclusion of these provisions could create ambiguity and misunderstanding as to the appropriate utilization review requirements for workers' compensation. One commenter asked whether the Texas Labor Code Section 413.011(a)(2), concerning treatment guidelines, conflicts with proposed sec.19.1705(3). The commenter also asked that the agency clarify whether the limitation on the liability of workers' compensation carriers for medical benefits established by Texas Labor Code Section 408.021 conflicts with proposed sec.19.1705. One commenter asked that the department clarify whether the department intends proposed sec.19.1719(b)(1) to apply to a workers' compensation carrier that delivers or issues for delivery a workers' compensation policy in Texas and performs utilization review. Response. The department has deleted language proposed in sec.19.1702(c), regarding the authority of the Texas Workers' Compensation Commission, and has renumbered the remaining subsection accordingly. It has also added language stating that the subchapter does not apply to review of health care services provided to patients under the authority of the Texas Workers' Compensation Act. This change is made pursuant to House Bill 3197, 75th Texas Legislature, which amended the Insurance Code Article 21.58A to require regulation of utilization review of a medical benefit under the Workers' Compensation Act, but which states it does not affect the authority of the Texas Workers' Compensation Commission to exercise the powers granted under its statute, which prevails in the event of a conflict. Accordingly, the department, in cooperation with the Texas Workers' Compensation Commission, will propose rules specific to workers' compensation utilization review, which will specify which provisions of the Insurance Code Article 21.58A apply to such review, and which provisions are in conflict with the Texas Workers' Compensation Act and therefore subject to the latter statute. sec.19.1702(d)(3)(B). One commenter suggested that the rules be clarified to ensure that the utilization review rules apply to the Primary Care Case Management (PCCM) program. The commenter stated that the Medicaid PCCM managed care utilization review activities are essentially similar to the utilization reviews performed by HMOs and are performed for the Texas Medicaid program by contract with an agency operating part of the state Medicaid managed care program. The commenter also noted that in some Medicaid service areas PCCM is a larger managed care system than the HMO model. Response. The department disagrees. The Primary Care Case Management model is a state administered model and does not fall within the definition of an HMO. The Medicaid program is specifically exempted from compliance with the Act. sec.19.1703 Adverse Determination. One commenter recommended using the definition of adverse determination found in Senate Bills 384 and 386. Response. The department believes that the definition of "adverse determination" complies with the legislative intent of Senate Bills 384 and 386 by clarifying that all adverse determinations, whether based on medical necessity or appropriateness of the recommended treatment, are subject to the appeals process and independent review. The department wants to ensure that the utilization review process is not used to ration health care by denying treatment simply because it is costly. sec.19.1703. Emergency Care. One commenter requested that the "emergency care" definition clarify what would be considered "recent onset," and asked whether the definition excludes care rendered in an inpatient setting. The commenter requested additional guidance as to how the components of the definition apply to behavioral health services. Response. The phrase "recent onset and severity" indicates that the patient's condition reached a severity level such that the patient would be led, as a prudent layperson, to believe that immediate medical care was needed. The department believes that the language is clear, yet not restrictive. The definition of emergency care primarily includes care rendered in a hospital emergency room setting. sec.19.1703. Life-threatening. Two commentors recommended that the department clarify the applicability of the definition of "life-threatening" to behavioral health services. One commenter suggested amending the definition of "life- threatening" to include language that the likelihood of death is probable and imminent unless the course of the disease or condition is immediately interrupted. Response. The department is reviewing the statutory definitions in relation to behavioral health services and is working with the Texas Department of Mental Health and Mental Retardation to develop guidelines for behavioral health services. The definition of "life-threatening" is statutory and the department does not believe that clarifying language is necessary. sec.19.1703. Open Records Law. One commenter suggested that the word "patient" seems to have been inadvertently included. Response. The reason for the comment is unclear, as it does not appear that the published rule included "patient" inappropriately. sec.19.1704. One commenter suggested that the section require additional items to be submitted for continued licensure. The commenter inquired whether the other items must be furnished when the adopted rules become effective or at the time of license renewal. Response. Clarifying language has been added to require that a currently licensed utilization review agent file additional items with the department by March 1, 1998. sec.19.1704(c)(11). One commenter suggested that there is no specific directive in Senate Bill 384 for utilization review agents to submit organizational and biographical information. The commenter asked that the department identify the statutory source of the language. Response. This information is requested due to the requirements of Senate Bill 386 (Texas Insurance Code Article 21.58A(6A) and Article 21.58C(2)) which requires the department to assure the independence of the independent review organization review process. This information is needed to perform conflict checks with an independent review organization and utilization review agent and is also needed to identify the officers, directors and executives during licensure of the utilization review agent. sec.19.1704(c)(12). One commenter asked if the submission of biographical information applies only to physician reviewers; or to physician reviewers, nurses and health care providers obtaining medical information; or to all staff. If the submission of information applies to all staff, the commenter contends this will create massive filing requirements for utilization review agents. Response. The department recognizes the commenter's concerns regarding the required filing of biographical data on "staff," such as physicians, nurses, and each person conducting the review. The department agrees that biographical data on all persons except officers, directors and executives is not necessary, would be administratively burdensome, and has deleted the requirement to submit information on "each person conducting utilization review." The department has also changed sec.19.1704(c)(6) to be consistent with the change to (c)(12). sec.19.1705(2)(A). One commenter asked for clarification of the terms "special circumstances" and "complex conditions." Response. The department has added clarifying language that "special circumstance includes, but is not limited to, a person who has a disability, acute condition, or life-threatening illness." Because the department believes that this definition includes complex conditions, reference to complex conditions has been deleted. sec.19.1705(2)(H)(iv). One commenter suggested that the words "such data" may be missing from the sentence ". . . in the case of summary data, shall not be considered confidential . . ." Response. The department agrees with the commenter and has made the necessary clarifying changes. sec.19.1705(2)(I). One commenter suggested that to be consistent with sec.12.208(c) of the independent review organization rules, utilization review agents should be required to not only notify physicians and health care providers of their intent to publish provider-specific information but also to obtain prior written consent from the affected physicians or health care providers. Response. The department agrees that the independent review organization rules require prior written consent from physicians and health care providers to publish provider-specific information; however, this provision mirrors statutory language which does not require prior written consent from physicians and other health care providers. sec.19.1705(3). One commenter suggested that the screening criteria used should be accessible to the public and inquired whether making the criteria confidential conflicts with the statutory requirement to state the source of the screening criteria in the notification of adverse determination. Response. Screening criteria are not subject to the Open Records Act under Article 21.58A sec.4(i). The source of the screening criteria does not constitute the entire screening criteria, and releasing the source would not subject the screening criteria to release under the Open Records Act. The confidentiality provision in the Act does not apply to identification of the source that developed the screening criteria. sec.19.1706. One commenter questioned if a call to a utilization review agent from a facility, admitting/UR department or MDO may be received by an individual other than a nurse, physician or health care provider. The commenter pointed out that the American Accreditation Healthcare Commission/URAC allows non-clinical staff to obtain clinical information. Response. The Act now requires that personnel who obtain information regarding a patient's specific medical condition, diagnosis and treatment options or protocols directly from a physician, dentist or health care provider shall be nurses, physician's assistants or other health care providers qualified to provide the service. However, the Act allows non-clinical personnel to perform clerical or administrative tasks. If the staff answering the phones perform only clerical or administrative tasks, such as transferring a call, they need not be clinical personnel. sec.19.1706(d). One commenter suggested adding clarifying language that the utilization review personnel who are under contract be subject to the same rules and regulations as the other employees and that the utilization review agent retain responsibility for contracted personnel actions and their appropriate supervision. Response. The department believes the language is clear and that no clarifying language is necessary. A utilization review agent, as a licensed entity, is responsible for ensuring that all of its operations comply with the Act, including the actions of its employees and contracted personnel. sec.19.1708(f). Two commentors requested the deletion of this section, which they say prohibits observation of psychotherapy sessions or the submission or review of a mental health therapist's process or progress notes. It is one commenter's belief that this provision will create a significant impediment to utilization review of behavioral health services. Both commentors suggested that a psychotherapist's process and/or progress notes are the patient's medical records and that utilization review agents should have access to them. Two commentors strongly support the language regarding confidentiality, which prohibits observation of psychotherapy sessions/access to therapy notes. Response. The department believes that confidentiality is needed because the therapist's notes may include information not directly relevant to the medical condition or treatment of the patient and may include information which is of a highly intimate and/or embarrassing nature. Observation of psychotherapy sessions by anyone other than the psychotherapist could, in all likelihood, impede full disclosure of medical history and problems and invade the psychotherapist/patient relationship. Psychotherapist's process and/or progress notes sometimes contain highly confidential, personal, and sometimes embarrassing information that is not necessary to determine medical necessity. The utilization review agent can use other records included in the medical records such as a case summary, discharge summary, lab results, history and physical information to determine medical necessity or appropriateness of mental health care. The department believes this portion of the rule will effectively protect a patient's privacy in such situations, while not compromising the utilization review agent's ability to use other pertinent records to determine medical necessity or appropriateness of health care. In addition, the department believes that this provision is consistent with the intent of the Legislature in Senate Bill 384. The department appreciates the comments in favor of the prohibition on observation of psychotherapy sessions and access to therapy notes. sec.19.1709(a). One commenter suggested adding "and patient" after "provider of record" in the first sentence, stating that the patient's consent for a utilization review agent's observing, participating in, or otherwise being present during a patient's examination, treatment, procedure or therapy should be required, not just the provider's. Response. The department disagrees, as the language is statutory; however, the physician may act on the patient's behalf as stated in sec.5.08(e) and (f) of the Medical Practice Act. sec.19.1710. One commenter suggested that the rules be revised to distinguish between long-term prospective referral requests and concurrent review requests, for which patients are entitled to a two-day determination. The commenter stated that in many instances utilization review agents are presented with requests for prospective review of referral requests made six months or even a year in advance. Response. The department disagrees, as all determinations must be made within the time frame required by statute. If sufficient information is not available at the time of the request, the utilization review agent should deny the request until enough information is available to make a determination. sec.19.1710(a). One commenter suggested striking the "or" and substituting "and" in the last clause of sec.19.1710(a). The commenter believes that both the patient and the provider of record should receive the notice of adverse determination. Response. The department disagrees with the comment because the statute requires that only one of the named individuals be notified of the determination. sec.sec.19.1710(b) and 19.1716(b)(7). One commenter noted there are typographical errors in these provisions. Response. The department agrees with and appreciates the comment and has changed the language accordingly. sec.19.1710(c)(2). One commenter requested clarification as to what will be considered adequate notice of the "clinical basis for adverse determination." Response. The department does not agree that "clinical basis" needs to be further defined. Notification of adverse determinations must clearly inform the patient of the specific factors considered in making this particular determination. The term "clinical basis" is included to require an analysis of the patient's unique situation and to prevent a conclusory notice that the required treatment was not necessary. sec.19.1710(d)(3). One commenter requested clarification as to what is considered "post-stabilization care." The commenter asked whether this applies only to care provided in a hospital emergency or other comparable facility, and whether it includes inpatient care, home care, follow-up care, etc. following an emergency. The commenter also asked whether there is any time limitation with respect to what is considered post-stabilization care, e.g. whether post- stabilization care is care rendered immediately following the stabilization of the emergency condition. Response. Post-stabilization care will be determined by the treating physician or health care provider at the hospital emergency facility or a comparable facility. The definition of emergency care primarily includes care rendered in an inpatient setting. Post-stabilization care can also include home care, follow-up care, etc. However, an HMO may require post-stabilization care to be performed within its network of physicians or providers. The time limitation for post-stabilization care is not defined but will be considered as the time appropriate to the circumstances related to the delivery of services and the condition of the patient, as determined by a physician and current medical practice. sec.19.1710(e). One commenter suggested deleting "and" and adding "or" in the last sentence. The commenter believes there are at least two other places in the rule that address notification requirements, sec.sec.19.1710(a) and 19.1712(b)(5), but the language in these two cites uses the term "or" instead of "and." Response. The department agrees with adding "or" but not with deleting "and," which relates to the document that must be provided and not to the individual who must receive notice. The department has made the necessary changes. sec.19.1712. One commenter asked if an HMO's existing complaint and appeal process which conforms to statutory grievance and complaint rules also complies with the utilization review appeal procedures, or whether separate and parallel appeal procedure systems are required. It is the commenter's opinion that requiring two separate appeal processes would be confusing and very difficult to administer. One commenter stated that clarification should be made in the rules expressly authorizing utilization review agents to define and explain where and with whom an appeal should be filed. The commenter stated that without a formal filing point or designation, a utilization review agent cannot practically meet the processing and notification requirements of the rule, nor accrue the necessary reporting data outlined in sec.19.1716. One commenter stated that the definition of "complaint" in the utilization review rules is different from the definition of complaint in 25 TAC sec.sec.119.1 - 119.71. The commenter asked which definition governs an HMO which is also a utilization review agent. Response. The complaint/appeals process is intended to be one integrated process. The department will review the HMO laws and rules in regard to this matter and, if necessary, will propose changes to the HMO rules. The definition of "complaint" in the HMO rules specifically includes "an appeal of an adverse determination," as well as any enrollee dissatisfaction. The definition of complaint in these rules does not include appeals of an adverse determination because the process to respond to a denial of an adverse determination is already defined by the Utilization Review Act in other sections. The definition of complaint and an appeal of an adverse determination do not conflict and can be used in harmony with one another. Complaints as defined by the utilization review rules include all other complaints not already defined (i.e. administrative, qualifications of personnel, and the overall utilization review process). The department does not agree that clarification is needed. The appeal process is clearly defined in sec.19.1712. sec.19.1712(b). One commenter requested clarification of what constitutes a reasonable procedure for appeals. Another commenter stated that the department should clarify that subsection (b)(2) does not apply to expedited appeals, as the expedited appeals process time frame is resolved well before issuing the acknowledgment letter. A commenter stated that the rules should clarify that if a utilization review agent's own appeal procedures call for resolution of all appeals "and not just expedited appeals" in less than the five working days set forth in this section, then the utilization review agent is not required to send an acknowledgment letter or complaint form. Response. A "reasonable" appeals process is defined in sec.19.1712(b)(1) - (6). The department believes that these detailed requirements appear to adequately define the process. The department believes that there is no reason to change this provision, which is required by the statute. However, the requirement can be met by sending the acknowledgment and the resolution in the same letter. sec.19.1712(b) and (c). One commenter asked if the one-page complaint form will be promulgated by the department or if the utilization review agent may create its own form, and if so, whether there are requirements for the form. One commenter suggested the rule list the provisions regarding appeals of adverse determinations. Response. Each utilization review agent will create its own form. The content requirements of the form are listed in sec.19.1712(b) and (c). However, the department agrees that clarification is needed and has added the appropriate language to subsection (b)(2). sec.19.1712(b)(3). One commenter suggested that the agency rewrite subsection (b)(3) for clarification. The commenter suggested the following language: "a provision that appeal decisions shall be made by a physician, or dentist, as appropriate. A provider may request a reconsideration of a utilization review decision by a specialist within 10 days of the date of notification of adverse determination. The provider must show good cause for the request for specialty review. The reconsideration will be performed by a health care provider of the same or similar specialty which would normally manage the service or care. Specialty reviews shall be completed within 15 working days of receipt of the request for reconsideration." Response. The department believes that the suggested language conflicts with the statutory provision and that the rule is sufficiently clear as written. sec.19.1712(b)(4). One commenter requested clarification to as to what is considered "the same or similar specialty as typically manages the medical condition, procedure, or treatment under review." Response. The department believes that no clarification is needed in the rule. However, the following example of same or similar specialty review is provided. This is merely an example and same or similar specialty review may include situations other than the following: A newborn receives denial of days in a neonatal intensive care unit. The appeal would be reviewed by a neonatologist. sec.sec.19.1712(b)(5) and 19.1713(c). One commenter suggested that the reference should be to physician or health care provider "of record" as is used elsewhere throughout the rules. Response. The department agrees and has made the changes. sec.19.1712(c). One commenter suggested clarifying that the notice regarding an appealing party's right to seek review of a denial by an independent review organization is available only after exhausting all levels of appeals, except in the case of a life-threatening condition. One commenter stated that the requirement to notify the appealing party of the independent review organization process should be stayed until independent review organizations are certified and operational. Response. The department believes the rule is clear as written. However, clarifying language has been added to sec.19.1721(c) concerning Independent Review of Adverse Determinations. It is not necessary to delay notification to the appealing party since Article 21.58C authorizing independent review organizations became effective on September 1, 1997, and an independent review organization was certified by the department on November 5, 1997 and is operational. In addition, the independent review organization rules have been adopted by the Commissioner. sec.19.1713(c). One commenter stated that the department should include additional details as to when and in what format the written description of the procedures for responding to post-stabilization care should be submitted. The commenter asked whether the information should be resubmitted periodically. Response. The department agrees additional language is needed concerning changes in the original application to clarify when documentation must be filed. The department has changed this section to allow for a currently licensed utilization review agent's amendments to the original application to be filed with the department for approval before March 1, 1998. Additionally, any changes in the procedures must be submitted not later than 30 days after the date the change takes effect. The procedures set forth by the Act should be submitted in the documentation sent to the department concerning the utilization review agent's phone access and can be in the utilization review agent's own format. sec.19.1714. One commenter suggested adding a new subsection which ensures that the identity of a physician or specialist performing review activities not be considered "personal information." The commenter provided sample language. One commenter suggested that the rule define "personal information" to include name, address, telephone number, social security number and financial information, at a minimum. Response. The department does not agree that a new subsection is needed. The department agrees that personal information does not include physician and specialist names and has added clarifying language regarding such information to include the minimum information suggested by the commenter. sec.19.1716(b)(6). It is one commenter's belief that the department would already have information on the number of referrals to an independent review organization, the name of the independent review organization, and the disposition of the review. Response. The department agrees and has deleted paragraph (6) regarding the number of referrals, name of independent review organization and disposition of the review. sec.19.1719(a)(3). One commenter stated that additional detail should be included as to when and in what format HMOs must submit written documentation to the department. Response. The department agrees and has added clarification concerning when documentation must be submitted by an HMO, and has specified that HMOs are required to file documentation as outlined in sec.19.1704(c) and (d). sec.19.1720(g). One commenter suggested the agency clarify to whom the phrase in subsection (g) "shall be licensed or otherwise authorized to provide . . ." refers. Another commenter suggested the agency clarify the last section of (h) by adding the term "same specialty as the provider of record." Response. The department does not believe that either clarification is necessary. This language was added to include not only licensed specialists but other providers that may be certified, registered, or otherwise authorized to practice in the United States. The language suggested by the commenter adding "same specialty as the provider of record" is in conflict with statutory language and will not be added. sec.19.1721. One commenter stated that this section should be stayed until the independent review organization certification process is developed and independent review organizations are certified and operational. A commenter suggested changing subsection (a) by inserting "for accessing independent review" at the end of the second sentence and changing the last sentence to "Such notification shall describe how to obtain independent review of such a determination and how the department assigns a request for review to an independent review organization. The notification will include the enrollee information form for requesting the review." Response. It is not necessary to delay any of the notifications since Article 21.58C authorizing independent review organizations became effective on September 1, 1997, and an independent review organization was certified by the department on November 5, 1997 and is operational. In addition, the independent review organization rules have been adopted by the Commissioner. The department agrees with inserting "for accessing independent review" and has included the change. However, the department believes that the last sentence of subsection (a) is clear as written. sec.19.1721(b). One commenter suggested replacing "life-threatening" with "emergency" in the sentence, "The enrollee, person acting on behalf of the enrollee, or the enrollee's provider of record shall determine the existence of a life-threatening condition on the basis that a prudent layperson possessing an average knowledge of medicine and health would believe that his or her disease or condition is a life-threatening condition." One commenter suggested the department consider amending the proposed language regarding a medical determination and definition of "life-threatening." Specifically, the commenter suggested deleting "prudent layperson" language in this section. The commenter expressed concern that if a condition is considered "life-threatening," the enrollee can skip the internal appeal process and go directly to the independent review organization. It is the commenter's position that if the enrollee can make this determination on his or her own, it is likely that more cases will go to an independent review organization because they are considered "life- threatening." Also, if a condition is considered "life-threatening" an expedited appeal procedure will apply which mandates the review be done by a physician who is of the same or similar specialty as typically manages the medical condition. The commenter believes more cases will have to be referred to a specialist for review even if the enrollee does not ask immediately for appeal to an independent review organization. Response. The department does not agree with the commenter. The definition of life-threatening and provisions regarding treatment of life-threatening conditions is statutory language. Senate Bill 386 only references life- threatening and does not reference emergency care. The Utilization Review Advisory Committee was concerned that the Utilization Review Act was silent as to who determines whether a condition is life-threatening. Based on the committee's recommendation, clarification was added stating that a prudent layperson possessing an average knowledge of medicine and health shall make the determination of the presence of a life-threatening condition. The department recognizes that the definition may cause additional requests to an independent review organization without going through the utilization review appeal process and that more cases may have to be referred to a specialist for the appeal review even if the enrollee does not ask immediately for an independent review. However, the department agrees with the recommendation of the advisory committee and has added language stating "a prudent layperson possessing an average knowledge of medicine and health would believe that his or her disease or condition is a life-threatening condition." The request for an independent review must be sent to the utilization review agent, HMO or insurer to begin the independent review process. Therefore, the utilization review agent, HMO or insurer will have the opportunity to perform an expedited review to resolve the issue within three days of receipt of a request for independent review. sec.19.1721(c). One commenter suggested slight wording changes to the last sentence in this subsection. One commenter suggested modifying this subsection to ensure that the party has completed the internal appeal process prior to seeking review of the determination. It is the commenter's belief that this will clarify that enrollees have access to the independent review organization only after exhausting the internal appeal procedures. One commenter acknowledged that the department is trying to create a single form which can be used with all adverse determinations but using the term utilization review agent will confuse the HMO members. The commenter suggested that the form should make the name of the utilization review agent a variable so that the name of the HMO, health plan, utilization review agent, etc. can be inserted. Another commenter stated that there is no requirement to provide a notice explaining the enrollee's right to legal remedy and asks why TDI is requiring such notice to be sent to the enrollee. The commenter requested that the department strongly consider not requiring utilization review agents to provide the notice. Response. The department agrees that clarification of subsection (c) is needed and has changed the language accordingly. The department agrees that using the term utilization review agent may confuse HMO members; accordingly, changes have been made to the notification form to allow the entity sending the notification to insert its name rather than the term "utilization review agent." The department agrees that there is no requirement to provide a notice explaining the patient's right to legal remedy; therefore, the department will not require such a notice. Patients will receive notification informing them of their right to the independent review process. For: National Association of Social Workers, Texas Society for Clinical Social Work, and The Disability Policy Consortium. For, with changes: Liberty Mutual Group, Blue Cross Blue Shield of Texas, Texas Medical Association, Alliance of American Insurers, Prudential Insurance Companies, Office of Public Insurance Counsel, Kaiser Foundation Health Plan of Texas, Inc., Children's Hospital Association of Texas, Texas Health Maintenance Organization Association, Texas Workers' Compensation Insurance Fund, and Harris Methodist Health Plan. The amendments are adopted under the Insurance Code Articles 21.58A and 1.03A. The Insurance Code Article 21.58A provides that the commissioner may promulgate such reasonable rules and regulations as are necessary and proper to carry out the provisions of the article. In addition, it provides that the commissioner shall appoint an 11-member advisory committee to advise the department in developing such rules and regulations. The Insurance Code Article 1.03A provides that the Commissioner of Insurance may adopt rules and regulations to execute the duties and functions of the Texas Department of Insurance as authorized by statute. Government Code Chapter 2001, sec.sec.2001.004 et seq. authorizes and requires each state agency to adopt rules of practice setting forth the nature and requirement of available procedures and prescribes the procedures for adoption of rules by a state administrative agency. sec.19.1702. Limitations on Applicability. (a) Except as noted in sec.19.1719 of this title (relating to Responsibility of HMOs and Insurers Performing Utilization Review under the Insurance Code Article 21.58A, sec.14(g) and (h)), all utilization review agents performing utilization reviews of services provided or proposed to be provided to an individual within the state on or after June 1, 1992, regardless of where the utilization review activities are physically based, must comply with this subchapter. All regulations in this subchapter shall relate to persons or entities subject to this subchapter. (b) Insurers and HMOs are not required to obtain a certificate of registration, but must comply with sec.19.1719 of this title. (c) This subchapter does not apply to a utilization review agent or other person which conducts only the functions of categories of utilization review listed in paragraphs (1)-(3) of this subsection: (1) a person who provides information to enrollees about scope of coverage or benefits provided under a health insurance policy or health benefit plan and who does not determine whether particular health care services provided or to be provided to an enrollee are medically necessary or appropriate; (2) a person, as defined in sec.19.1703 of this title (relating to Definitions), performing utilization review who is employed by, or under contract to, a certified utilization review agency; (3) a utilization review agency which conducts only the categories of utilization review listed in subparagraphs (A)-(E) of this paragraph: (A) reviews performed pursuant to any contract with the federal government for utilization review of patients eligible for services under Title XVIII or XIX of the Social Security Act (42 United States Code sec.sec.1395 et seq. or sec.sec.1396 et seq.); (B) reviews performed for the Texas Medicaid Program, except reviews performed by a health maintenance organization that contracts with the Health and Human Services Commission or an agency operating part of the state Medicaid managed care program to provide health care services to recipients of medical assistance under Chapter 32, Human Resources Code; the Chronically Ill and Disabled Children's Services Program created pursuant to Chapter 35, Health and Safety Code, any program administered under Title 2, the Human Resources Code, any program of the Texas Department of Mental Health and Mental Retardation, or any program of the Texas Department of Criminal Justice; (C) reviews of health care services provided to patients under the authority of the Texas Workers' Compensation Act (Texas Civil Statutes, sec.8308-1.01 et seq.); (D) reviews of health care services provided under a policy or contract of automobile insurance promulgated by the department under the Insurance Code, Subchapter A, Chapter 5 or issued pursuant to the Insurance Code, Article 1.14; or (E) reviews that apply to the terms and benefits of the employee welfare benefit plans as defined in sec.3(1) of the Employee Retirement Income Security Act of 1974 (29 U.S.C. Section 1002(1)). sec.19.1704. Certification of Utilization Review Agents. (a) An application for certification of a utilization review agent must be filed with the Texas Department of Insurance at the following address: Texas Department of Insurance, Mail Code 108-6A, P.O. Box 149104, Austin, Texas 78714- 9104. (b) The application must be submitted on a form which can be obtained from the Utilization Review Section, Mail Code 108-6A, Texas Department of Insurance, 333 Guadalupe, P. O. Box 149104, Austin, Texas 78714-9104. (c) The attachments to the application form require the following information: (1) a summary description of the utilization review plan which must include the matters listed in subparagraphs (A) and (B) of this paragraph. The utilization review plan must meet the requirements of sec.19.1705 of this title (relating to General Standards of Utilization Review); (A) an adequate summary description of screening criteria and review procedures to be used to determine medical necessity and appropriateness of health care; and (B) a certification, signed by an authorized representative of the company that screening criteria and review procedures to be applied in review determination are established with input from appropriate health care providers and approved by physicians; (2) copies of procedures established for appeal of an adverse determination. These procedures must comply with the provisions of sec.19.1712 of this title (relating to Adverse Determinations of Utilization Review Agents); (3) copies of procedures established for handling oral or written complaints by enrollees, patients, or health care providers. These procedures must comply with sec.19.1716 of this title (relating to Complaints and Information); (4) copies of policies and procedures which ensure that all applicable state and federal laws to protect the confidentiality of medical records are followed. These procedures must comply with sec.19.1714 of this title (relating to Confidentiality); (5) a certification signed by an authorized representative of the company that the utilization review agent will comply with the provisions of the Act; (6) a description of the categories of persons and names of the personnel employed or contracted to perform utilization review; (7) a description of the hours of operation within the State of Texas and how the utilization review agent may be contacted during weekends and holidays. This description must be in compliance with sec.19.1713 of this subchapter (relating to Utilization Review Agent's Telephone Access); (8) representative samples of all materials provided by the utilization review agent/applicant to inform its clients, enrollees or providers of the requirements of the utilization review plan. Samples shall include language for notification of an adverse determination made in a utilization review; (9) a description of the basis by which the utilization review agent compensates its employees or agents to ensure compliance with paragraph (10) of this subsection; (10) a certification signed by an authorized representative that the utilization review agent shall not permit or provide compensation or anything of value to its employees or agents, condition employment or its employee or agent evaluations, or set its employee or agent performance standards, based on the amount or volume of adverse determinations, reductions or limitations on lengths of stay, benefits, services, or charges or on the number or frequency of telephone calls or other contacts with health care providers or patients, which are inconsistent with the provisions of this subchapter. (11) the organizational information, documents and all amendments, including: (A) the bylaws, rules and regulations, or any similar document regulating the conduct of the internal affairs of the applicant with a notarized certification bearing the original signature of an officer or authorized representative of the applicant that they are true, accurate, and complete copies of the originals; (B) for an applicant that is publicly held, the name of each stockholder or owner of more than five percent of any stock or options; (C) a chart showing the internal organizational structure of the applicant's management and administrative staff; and (D) a chart showing contractual arrangements of the utilization review agent. (12) the name and biographical information for each director, officer and executive of the applicant. (d) The utilization review agent shall report any material changes in the information in the application or renewal form referred to in this section, not later than the 30th day after the date on which the change takes effect. Material changes include, but are not limited to, new personnel hired who are officers and directors who perform utilization review; changes in the organizational structure; changes in contractual relationships and changes in the utilization review plan. (e) The application process is described in paragraphs (1)-(6) of this subsection. (1) The department shall have 60 days after receipt of an application to process the application and to certify or deny it. The department shall give the applicant written notice of any omissions or deficiencies noted as a result of the review conducted pursuant to this paragraph. (2) The applicant must correct the omissions or deficiencies in the application within 30 days of the date of the department's latest notice of such omissions or deficiencies. If the applicant fails to do so, the application file will be closed as an incomplete application. The application fee will not be refundable. (3) The applicant may waive any of the time limits described in this subsection, except in paragraph (2). The applicant may waive the time limit in paragraph (2) of this subsection, only with the consent of the department. (4) The department shall maintain an application file which shall contain the application, notices of omissions or deficiencies, responses and any written materials generated by any person that was considered by the department in evaluating the application. (f) A utilization review agent must apply for renewal of the certificate of registration every two years from the date of certification. A renewal form must be used for this purpose. The renewal fee must be submitted with the renewal form. The renewal form can be obtained from the address listed in subsection (b) of this section. The completed renewal form, a summary of the current screening criteria, a statement signed by an authorized representative of the company certifying that all information previously submitted is true and correct and all changes have been previously filed to the application certified by the department, and the renewal fee must be submitted to the department at the address listed in subsection (a) of this section. A utilization review agent may continue to operate under its certificate of registration if the information and the fee have been filed for renewal and timely received by the department, until the renewal is finally denied or issued by the department. If the required information and fee is not received prior to the deadline for renewal of the certificate of registration the certificate of registration will automatically expire and the utilization review agent must complete and submit a new application form and a new fee with all required information. (g) If an application or renewal is initially denied under this section, the applicant or registrant may appeal such denial under the terms of the provisions of Chapter 1, Subchapter A of this title (relating to Rules of Practice and Procedure) and Government Code, Chapter 2001 . A hearing of such appeal shall be conducted within 45 days of the date the petition for such hearing is filed with the commissioner. A decision by the commissioner shall be rendered within 60 days of the date of the hearing. (h) An applicant for a certificate of registration as a utilization review agent must provide evidence that the applicant: (1) has available the services of physicians, nurses, physician's assistants, or other health care providers qualified to provide the service requested by the provider to carry out its utilization review activities in a timely manner; (2) meets any applicable provisions of this chapter and regulations relating to the qualifications of the utilization review agents or the performance of utilization review; (3) has policies and procedures which protect the confidentiality of medical records in accordance with applicable state and federal laws; (4) makes itself accessible to patients and providers 40 working hours a week during normal business hours in this state in each time zone in which it operates. (i) Utilization review agents that have received their certificate of registration prior to the adoption of these rules, must file with the department all changes to their original application as set forth in subsections (c) and (d) of this section by March 1, 1998. sec.19.1705. General Standards of Utilization Review. The utilization review plan, including reconsideration and appeal requirements, shall be reviewed by a physician and conducted in accordance with standards developed with input from appropriate health care providers, including practicing health care providers that are both primary and specialty physicians, and approved by a physician. The utilization review plan shall include the following components: (1) a description of the elements of review which the utilization review agent provides such as: (A) prospective review: (i) hospital admission; (ii) procedures (such as surgical and non-surgical procedures); (iii) courses of outpatient treatment; (B) second surgical opinion; (C) discharge planning; (D) concurrent review; (E) readmission review; and (F) continued stay authorization; (2) written procedures for: (A) identification of individuals with special circumstances who may require flexibility in the application of screening criteria through utilization review decisions. Special circumstances includes, but is not limited to, a person who has a disability, acute condition, or life-threatening illness. (B) notification of the utilization review agent's determinations provided to the enrollee, a person acting on behalf of the enrollee, or the enrollee's provider of record as addressed in sec.19.1710 of this title (relating to Notice of Determinations Made by Utilization Review Agents); (C) appeal of an adverse determination and a copy of any forms used during the appeal process, as required by sec.19.1711 and sec.19.1712 of this title (relating to Requirements Prior to Adverse Determination and Appeal of Adverse Determinations of Utilization Review Agents); (D) receiving or redirecting a toll-free normal business hour and after-hour calls, either in person or by recording, and assurance that a toll-free number will be maintained 40 hours per week during normal business hours as addressed in sec.19.1713 of this title (relating to Utilization Review Agent's Telephone Access); (E) review including: (i) any form used during the review process; (ii) time frames that shall be met during the review; (F) handling of oral or written complaints by enrollees, patients, or health care providers as addressed in subsection (a) of sec.19.1716 of this title (relating to Complaints and Information); (G) determining if physicians or other health care providers utilized by the utilization review agent are licensed, qualified, and appropriately trained; (H) assuring that patient-specific information obtained during the process of utilization review, as addressed in sec.19.1714 of this title (relating to Confidentiality), will be: (i) kept confidential in accordance with applicable federal and state laws; (ii) used solely for the purposes of utilization review, quality assurance, discharge planning, and catastrophic case management; (iii) shared with only those agencies (such as the claims administrator) who have authority to receive such information; and (iv) in the case of summary data, such data shall not be considered confidential if it does not provide sufficient information to allow identification of individual patients; (I) providing prior written notice to a physician or health care provider when publishing data, including quality review studies or performance tracking data which identifies a particular physician or health care provider; (3) screening criteria. Each utilization review agent shall utilize written medically acceptable screening criteria and review procedures which are established and periodically evaluated and updated with appropriate involvement from the physicians, including practicing physicians, dentists, and other health care providers. Utilization review decisions shall be made in accordance with currently accepted medical or health care practices, taking into account special circumstances of each case that may require deviation from the norm stated in the screening criteria. Screening criteria must be objective, clinically valid, compatible with established principles of health care, and flexible enough to allow deviations from the norm when justified on a case-by-case basis. Screening criteria must be used to determine only whether to approve the requested treatment. Denials must be referred to an appropriate physician, dentist, or other health care provider to determine medical necessity. Such written screening criteria and review procedures shall be available for review and inspection to determine appropriateness and compliance as deemed necessary by the commissioner or his or her designated representative and copying as necessary for the commissioner to carry out his or her lawful duties under the Insurance Code, provided, however, that any information obtained or acquired under the authority of this chapter and the Act, is confidential and privileged and not subject to the open records law or subpoena except to the extent necessary for the commissioner to enforce this chapter and the Act; (4) delegation of review. Provide circumstances, if any, under which the utilization review agent may delegate the review to a hospital utilization review program or a health care provider. Such delegation shall not relieve the utilization review agent of full responsibility for compliance with this subchapter and the Act including the conduct of those to whom utilization review has been delegated. sec.19.1710. Notice of Determinations Made by Utilization Review Agents. (a) A utilization review agent shall notify the enrollee, a person acting on behalf of the enrollee, or the enrollee's provider of record of a determination made in a utilization review. (b) Except in the case of adverse determinations which are addressed in subsection (d) of this section, the notification required by this section must be mailed or otherwise transmitted not later than two working days after the date of the request for utilization review and all medical information necessary to substantiate the need for the treatment or service recommended is received by the agent. (c) Notification of adverse determination by the utilization review agent must include: (1) the principal reasons for the adverse determination; (2) the clinical basis for the adverse determination; (3) a description or the source of the screening criteria that were utilized as guidelines in making the determination; (4) a description of the procedure for the complaint and appeal process; and (5) the independent review notification and the form prescribed by the commissioner. (d) The adverse determination notification must be provided: (1) within one working day by telephone or electronic transmission to the provider of record in the case of a patient who is hospitalized at the time of the adverse determination, to be followed by a letter notifying the patient and the provider of record of an adverse determination within three working days; (2) within three working days in writing to the provider of record and the patient if the patient is not hospitalized at the time of the adverse determination; or (3) within the time appropriate to the circumstances relating to the delivery of the services and the condition of the patient, but in no case to exceed one hour from notification when denying post-stabilization care subsequent to emergency treatment as requested by a treating physician or provider. In such circumstances, notification shall be provided to the treating physician or health care provider. (e) For life-threatening conditions, notification of adverse determination by the utilization review agent must be provided within the time frames addressed in subsection (d) of this section. At the time of notification of the adverse determination, the utilization review agent shall provide to the enrollee or person acting on behalf of the enrollee, and the enrollee's provider of record, the independent review notification and the form prescribed by the commissioner. sec.19.1712. Appeal of Adverse Determination of Utilization Review Agents. (a) A utilization review agent shall maintain and make available a written description of appeal procedures involving an adverse determination. (b) The procedures for appeals shall be reasonable and shall include the following: (1) a provision that an enrollee, a person acting on behalf of the enrollee, or the enrollee's physician or health care provider may appeal the adverse determination orally or in writing; (2) a provision that within five working days from receipt of the appeal the utilization review agent shall send to the appealing party a letter acknowledging the date of the utilization review agent's receipt of the appeal and include a reasonable list of documents needed to be submitted by the appealing party to the utilization review agent for the appeal. Such letter must also include provisions listed in subsections (b) and (c) of this section. When the utilization review agent receives an oral appeal of adverse determination, the utilization review agent shall send a one-page appeal form to the appealing party; (3) a provision that appeal decisions shall be made by a physician, or dentist, as appropriate, provided that, if the appeal is denied and within 10 working days the health care provider sets forth in writing good cause for having a particular type of a specialty provider review the case, the denial shall be reviewed by a health care provider in the same or similar specialty as typically manages the medical, dental, or specialty condition, procedure, or treatment under discussion for review of the adverse determination, and such specialty review shall be completed within 15 working days of receipt of the request; (4) in addition to the written appeal, a method for expedited appeal procedure for emergency care denials, denials of care for life-threatening conditions, and denials of continued stays for hospitalized patients. Such procedure shall include a review by a health care provider who has not previously reviewed the case who is of the same or a similar specialty as typically manages the medical condition, procedure, or treatment under review. The time in which such appeal must be completed shall be based on the medical or dental immediacy of the condition, procedure, or treatment, but may in no event exceed one working day from the date all information necessary to complete the appeal is received. (5) a provision that after the utilization review agent has sought review of the appeal of the adverse determination, the utilization review agent shall issue a response letter to the patient, a person acting on behalf of the patient, or the patient's physician or health care provider of record explaining the resolution of the appeal. Such letter shall include: (A) a statement of the specific medical, dental, or contractual reasons for the resolution; (B) the clinical basis for such decision; (C) the specialization of any physician or other provider consulted; and (D) notice of the appealing party's right to seek review of the denial by an independent review organization and the procedures for obtaining that review. (6) written notification to the appealing party of the determination of the appeal, as soon as practical, but in no case later than 30 days after the date the utilization review agent receives the appeal. (c) In a circumstance involving an enrollee's life-threatening condition, the enrollee is entitled to an immediate appeal to an independent review organization and is not required to comply with procedures for an internal review of the utilization review agent's adverse determination. sec.19.1713. Utilization Review Agent's Telephone Access. (a) A utilization review agent shall have appropriate personnel reasonably available by toll-free telephone at least 40 hours per week during normal business hours in both time zones in Texas, if applicable, to discuss patients' care and allow response to telephone review requests. (b) A utilization review agent must have a telephone system capable of accepting or recording or providing instructions to incoming calls during other than normal business hours and shall respond to such calls not later than two working days of the later of the date on which the call was received or the date the details necessary to respond have been received from the caller. (c) A utilization review agent must provide a written description to the commissioner setting forth the procedures to be used when responding to post- stabilization care subsequent to emergency treatment as requested by a treating physician or health care provider of record. sec.19.1714. Confidentiality. (a) A utilization review agent shall preserve the confidentiality of individual medical records to the extent required by law. (b) A utilization review agent may not disclose or publish individual medical records, personal information, or other confidential information about a patient obtained in the performance of utilization review without the prior written consent of the patient or as otherwise required by law. Personal information shall include at a minimum, name, address, phone number, social security number, and financial information. If such authorization is submitted by anyone other than the individual who is the subject of the personal or confidential information requested, such authorization must: (1) be dated; and (2) contain the signature of the individual who is the subject of the personal or confidential information requested. The signature must have been obtained one year or less prior to the date the disclosure is sought or the authorization is invalid. (c) A utilization review agent may provide confidential information to a third party under contract or affiliated with the utilization review agent for the sole purpose of performing or assisting with utilization review. Information provided to third parties shall remain confidential. (d) If an individual submits a written request to the utilization review agent for access to recorded personal information about the individual, the utilization review agent shall within 10 business days from the date such request is received: (1) inform the individual submitting the request of the nature and substance of the recorded personal information in writing; and (2) permit the individual to see and copy, in person, the recorded personal information pertaining to the individual or to obtain a copy of the recorded personal information by mail, at the discretion of the individual, unless the recorded personal information is in coded form, in which case an accurate translation in plain language shall be provided in writing. (e) A utilization review agent's charges for providing a copy of recorded personal information to individuals shall not exceed ten cents per page and may not include any costs that are otherwise recouped as part of the charge for utilization review. (f) The utilization review agent may not publish data which identifies a particular physician or health care provider, including any quality review studies or performance tracking data without prior written notice to the involved health care provider. This prohibition does not apply to internal systems or reports used by the utilization review agent. (g) Documents in the custody of the utilization review agent that contain confidential patient information or physician or health care provider financial data shall be destroyed by a method which induces complete destruction of the information when the agent determines the information is no longer needed. (h) All patient, physician, and health care provider data shall be maintained by the utilization review agent in a confidential manner which prevents unauthorized disclosure to third parties. Nothing in this article shall be construed to allow a utilization review agent to take actions that violate a state or federal statute or regulation concerning confidentiality of patient records. (i) To assure confidentiality, a utilization review agent must, when contacting a physician's office or hospital, provide its certification number, the caller's name, and professional qualifications to the provider's named utilization review representative in the health care provider's office. (j) Upon request by the provider, the utilization review agent shall present written documentation that it is acting as an agent of the payor for the relevant patient. (k) The utilization review agent's procedures shall specify that specific information exchanged for the purpose of conducting reviews will be considered confidential, be used by the private review agent solely for the purposes of utilization review, and shared by the utilization review agent with only those third parties who have authority to receive such information, such as the claim administrator. The utilization review agent's process shall specify that procedures are in place to assure confidentiality and that the utilization review agent agrees to abide by any federal and state laws governing the issue of confidentiality. Summary data which does not provide sufficient information to allow identification of individual patients or providers need not be considered confidential. (l) Medical records and patient specific information shall be maintained by the utilization review agent in a secure area with access limited to essential personnel only. (m) Information generated and obtained by the utilization review agents in the course of utilization review shall be retained for at least two years if the information relates to a case for which an adverse decision was made at any point or if the information relates to a case which may be reopened. (n) Notwithstanding the provisions in subsections (a) - (m) of this section, the utilization review agent shall provide to the commissioner on request individual medical records or other confidential information for determination of compliance with this subchapter. The information is confidential and privileged and is not subject to the open records law, Government Code, Chapter 552, or to subpoena, except to the extent necessary to enable the commissioner to enforce this subchapter. sec.19.1716. Complaints and Information. (a) Utilization review agent's complaint system. A utilization review agent shall establish and maintain a complaint system that provides reasonable procedures for the resolution of oral or written complaints initiated by enrollees, patients, or health care providers concerning the utilization review and shall maintain records of such complaints for three years from the time the complaints are filed. The complaint procedure shall include a written response to the complainant by the agent within 30 days. (b) Utilization review agent's reporting requirements to the department. By March 1, of each year, the utilization review agent shall submit to the commissioner or his or her delegated representative, a summary report of all complaints at such times and in such form as the commissioner may require and shall permit the commissioner to examine the complaints and all relevant documents at any time. The summary report covers reviews performed by the utilization review agent during the preceding calendar year and includes: (1) the total number of written notices of adverse determinations; (2) a listing of appeals of adverse determinations, by the medical condition that is the source of the dispute using primary ICD-9 (physical diagnosis) or DSM-IV (mental health diagnosis) code, and by the treatment in dispute, if any, using CPT (procedure) code or other relevant procedure code if a CPT designation is not available, or any other nationally recognized numerically codified diagnosis or procedure; (3) the classification of appellant (i.e., health care provider, enrollee, patient, etc.); (4) the subject matter of the appeal of the adverse determination. Appeal of adverse determinations shall be categorized as follows: (A) benefit denial or limitation (e.g., treatment not pre-authorized, treatment not medically necessary, hospital stay not medically necessary, referral to specialty physician not provided); (B) timely determinations (e.g., utilization review agent not responding to requests in a timely manner, appropriate personnel not available by telephone); (C) screening criteria; (5) the disposition of the appeal of adverse determination (either in favor of the appellant, or in favor of the original utilization review determination) at each level of the notification and appeal process; (6) the subject matter of the complaint. Complaints shall be categorized as follows: (A) administration (e.g., copies of medical records not paid for, too many calls or written requests for information from provider, too much information requested from provider); (B) qualifications of utilization review agent's personnel; (C) appeal/complaint process (e.g., treating physician unable to discuss plan of treatment with utilization review physician, no notice of adverse determination, no notice of clinical basis for adverse determination, written procedures for appeal not provided). (c) Complaints to the department. Within a reasonable time period, upon receipt of a written complaint alleging a violation of this subchapter or the Act, by a utilization review agent, from an enrollee's health care provider, a person acting on behalf of the enrollee, or the enrollee, the commissioner or his or her delegated representative shall investigate the complaint, notify the utilization review agent of the complaint, require response by the utilization review agent addressing the complaint within 10 days of receipt of the complaint, and furnish a written response to the complainant and the utilization review agent named. The response will not identify in any manner, the patient or patients, without written consent. This response must include the following: (1) a statement of the original complaint; (2) a copy of any written response by the utilization review agent. The written response should not contain privileged medical records. If it is necessary to refer to medical records, they shall be separately forwarded with the response and clearly marked as privileged medical records; (3) a statement of the findings of the commissioner or his or her delegated representative and an explanation of the basis of such findings; (4) corrective actions, if any, on the part of the utilization review agent which the commissioner or his or her designated representative finds appropriate and whether the utilization review agent has voluntarily agreed to take such action; (5) a time frame in which any corrective actions should be completed. (d) Evidence of corrective action. The utilization review agent will provide evidence of corrective action within the specified time frame to the commissioner or his or her representative. (e) Authority of the department to make inquiries. In addition to the authority of the commissioner to respond to complaints described in subsection (b) of this section, the department is authorized to address inquiries to any utilization review agent in relation to the agents' business condition or any matter connected with its transactions which the department may deem necessary for the public good or for a proper discharge of its duties. It shall be the duty of the agent to promptly answer such inquiries in writing. (f) Lists of utilization review agents. The commissioner shall maintain and update monthly a list of utilization review agents issued certificates and the renewal date for those certificates. The commissioner shall provide the list at cost to all individuals or organizations requesting the list. (g) On-site review by the Texas Department of Insurance. (1) The commissioner or the commissioner's designated representative is authorized to make a complete on-site review of the operations of each utilization review agent at the principal place of business for such agent, as often as is deemed necessary. (2) Utilization review agents will be notified of the scheduled on-site visit by letter, which will specify, at a minimum, the identity of the commissioner's designated representative and the expected arrival date and time. (3) The utilization review agent must make available during such on-site visits all records relating to its operation. (4) The commissioner or the designated representative may perform periodic telephone audits of utilization review agents authorized to conduct business in this state, to determine if the agents are reasonably accessible. sec.19.1719. Responsibility of HMOs and Insurers Performing Utilization Review Under the Insurance Code, Article 21.58A, sec.14, (g) and (h). (a) HMOs performing utilization review. (1) HMOs performing utilization review under the Insurance Code, Article 21.58A, sec.14(g) shall be subject to sec.19.1701 of this title (relating to General Provisions), sec.19.1702 of this title (relating to Limitations on Applicability), sec.19.1703 of this title (relating to Definitions), sec.19.1704(c) and (d) of this title (relating to Certification of Utilization Review Agents), sec.19.1705 of this title (relating to General Standards of Utilization Review), sec.19.1706 of this title (relating to Personnel), sec.19.1707 of this title (relating to Prohibitions of Certain Activities of Utilization Review Agents), sec.19.1708 of this title (relating to Utilization Review Agent Contact with and Receipt of Information from Health Care Providers), sec.19.1709 of this title (relating to On-Site Review by the Utilization Review Agent), sec.19.1710 of this title (relating to Notice of Determinations Made by Utilization Review Agents), sec.19.1711 of this title (relating to Requirements Prior to Adverse Determination), sec.19.1712 of this title (relating to Appeal of Adverse Determination of Utilization Review Agents), sec.19.1713 of this title (relating to Utilization Review Agent's Telephone Access), sec.19.1714 of this title (relating to Confidentiality), sec.19.1715 of this title (relating to Retrospective Review of Medical Necessity), sec.19.1716 of this title (relating to Complaints and Information), sec.19.1717 of this title (relating to Administrative Violations), sec.19.1720 of this title (relating to Specialty Utilization Review Agent), and sec.19.1721 of this title (relating to Independent Review of Adverse Determinations) with respect to their operations under the provisions of the Act, sec.14(g). (2) When a health maintenance organization performs utilization review for a person or entity subject to this subchapter other than one for which it is the payor, such health maintenance organization shall be required to obtain a certificate under the Act, sec.3, and comply with all the provisions of the Act (3) Health maintenance organizations performing utilization review under the Act, sec.14(g) must register with the department and submit written documentation demonstrating compliance with all filing requirements defined in sec.19.1704(c) and (d) of this title (relating to Certification of Utilization Review Agents) and the name, address, contact name and phone number of the health maintenance organization. (4) A health maintenance organization, including a health maintenance organization that contracts with the Health and Human Services Commission or an agency operating part of the state Medicaid managed care program to provide health care services to recipients of medical assistance under Chapter 32, Human Resources Code, is subject to this article. (5) Health maintenance organizations must submit to assessment of maintenance taxes under the Insurance Code Article 20A.33, to cover the costs of administering compliance of health maintenance organizations under the Act. (b) Insurers performing utilization review. (1) An insurer that delivers or issues for delivery a health insurance policy in Texas is subject to the Insurance Code Article 21.58A and such insurer shall be subject to assessment of maintenance tax under the Insurance Code to cover the costs of administering compliance of insurers. (2) Insurers performing utilization review under the Insurance Code, Article 21.58A, sec.14 (g) will be subject to sec.19.1701 of this title (relating to General Provisions), sec.19.1702 of this title (relating to Limitations on Applicability), sec.19.1703 of this title (relating to Definitions), sec.19.1704(c) and (d) of this title (relating to Certification of Utilization Review Agents), sec.19.1705 of this title (relating to General Standards of Utilization Review), sec.19.1706 of this title (relating to Personnel), sec.19.1707 of this title (relating to Prohibitions of Certain Activities of Utilization Review Agents), sec.19.1708 of this title (relating to Utilization Review Agent Contact with and Receipt of Information from Health Care Providers), sec.19.1709 of this title (relating to On-Site Review by the Utilization Review Agent), sec.19.1710 of this title (relating to Notice of Determinations Made by Utilization Review Agents), sec.19.1711 of this title (relating to Requirements Prior to Adverse Determination), sec.19.1712 of this title (relating to Appeal of Adverse Determination of Utilization Review Agents), sec.19.1713 of this title (relating to Utilization Review Agent's Telephone Access), sec.19.1714 of this title (relating to Confidentiality), sec.19.1715 of this title (relating to Retrospective Review of Medical Necessity), sec.19.1716 of this title (relating to Complaint and Information), sec.19.1717 of this title (relating to Administrative Violations), sec.19.1720 of this title (relating to Specialty Utilization Review Agent), and sec.19.1721 of this title (relating to Independent Review of Adverse Determinations) with respect to their operations under the provisions of the Act, sec.14(h). (3) When an insurer performs utilization review for a person or entity subject to this subchapter other than one for which it is the payor, such insurer shall be required to obtain a certificate under the Act, sec.3, and comply with all the provisions of the Act. (4) Insurers performing utilization review under the Act, sec.14(h) must register with the department and submit written documentation demonstrating compliance with all the filing requirements defined in sec.19.1704(c) and (d) of this title (relating to Certification of Utilization Review Agents) and the name, address, contact name and phone number of the insurer. sec.19.1721. Independent Review of Adverse Determinations. (a) For life-threatening conditions, notification of adverse determination by the utilization review agent must be provided within the time frames addressed in sec.19.1710(d) of this title (relating to Notice of Determinations Made by Utilization Review Agents). At the time of notification of the adverse determination, the utilization review agent shall provide to the enrollee, or person acting on behalf of the enrollee, and the enrollee's provider of record, the notification and the form prescribed by the commissioner for accessing independent review. Such notification shall describe how to obtain independent review of such determination and how the department assigns a request for review to an independent review organization, and include the form requesting enrollee information. (b) The enrollee, person acting on behalf of the enrollee, or the enrollee's provider of record shall determine the existence of a life-threatening condition on the basis that a prudent layperson possessing an average knowledge of medicine and health would believe that his or her disease or condition is a life-threatening condition. (c) A utilization review agent shall permit any party who has completed the internal appeals process as defined in Insurance Code Article 21.58A sec.6 and such appeal of an adverse determination resulted in a denial by the utilization review agent, health maintenance organization or insurer, to seek review of that determination by an independent review organization assigned to the appeal in accordance with Insurance Code Article 21.58C as follows: (1) the utilization review agent shall provide a notification prescribed by the commissioner to the enrollee or the person acting on behalf of the enrollee and the enrollee's provider of record, on how to appeal the denial of an internal appeal to an independent review organization. The notification shall describe how to obtain independent review of such determination and how the department assigns a request for review to an independent review organization, and include the form requesting enrollee information. (2) the utilization review agent shall provide the notification and the form prescribed by the commissioner to the enrollee or the person acting on behalf of the enrollee and the enrollee's provider of record at the time of denial of the appeal; (3) the form prescribed by the commissioner shall be completed by the enrollee, person acting on behalf of the enrollee or the enrollee's provider of record and returned to the utilization review agent to begin the independent review process. The form prescribed by the commissioner authorizing release of medical information to the independent review organization must be signed by the enrollee or the enrollee's legal guardian. (d) The utilization review agent shall notify the department upon receipt of the request for an independent review. (e) The utilization review agent shall provide information contained in the form prescribed by the commissioner to the department. The notification and information shall be submitted via modem or, in the event that modem is unavailable, through facsimile. (f) The utilization review agent may access the department on working days, between 7 AM and 6 PM Central time, Monday through Friday, to obtain assignment of an independent review organization. (g) The department shall, within one working day of receipt of the request, randomly assign an independent review organization and notify the utilization review agent and the independent review organization of the assignment. The department shall send notification to the enrollee or person acting on behalf of the enrollee and the enrollee's provider of record no later than one working day after the assignment has been made. (h) Not later than the third working day after the date that the utilization review agent receives a request for review, the utilization review agent shall provide to the assigned independent review organization a copy of: (1) any medical records of the enrollee in the possession of the utilization review agent that are relevant to the review; (2) any documents used by the plan in making the determinations to be reviewed by the organization; (3) the written notification described by sec.19.1712(b)(6) of this title (relating to Appeal of Adverse Determination of Utilization Review Agents); (4) any documentation and written information submitted to the utilization review agent in support of the appeal; and (5) a list containing the name, address and phone number of each physician or health care provider who has provided care to the enrollee and who may have medical records relevant to the appeal. (i) The utilization review agent shall comply with the independent review organization's determination with respect to the medical necessity or appropriateness of health care items and services for an enrollee. (j) The utilization review agent shall pay for the independent review. (k) The utilization review agent may recover costs associated with the independent review from the payor. This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority. Issued in Austin, Texas, on December 1, 1997. TRD-9716037 Caroline Scott General Counsel and Chief Clerk Texas Department of Insurance Effective date: December 22, 1997 Proposal publication date: September 5, 1997 For further information, please call: (512) 463-6327 TITLE 31. NATURAL RESOURCES AND CONSERVATION PART II. Texas Parks and Wildlife Department CHAPTER 69.Resource Protection Issuance of Marl, Sand and Gravel Permits 31 TAC sec.sec.69.110, 69.114 The Texas Parks and Wildlife Commission, in a regularly scheduled public hearing on November 6, 1997, adopts amendments of sec.69.110 and sec.69.114, concerning rules for issuance of Marl, Sand and Gravel Permits without changes as published in the Texas Register on October 3, 1997 (22 TexReg 9859). Parks and Wildlife Code sec.86.006 and sec.86.020 authorizes the Commission to establish terms and conditions of permits it issues for marl, sand and gravel removal. The rule amendments are needed in order to reduce unnecessary costs to permit holders in the application for new permits and renewals of existing permits. The rule amendments are also necessary to provide a source of continuing revenue to the Department in order to provide for orderly administration and enforcement of the rules. The Department received no comments in opposition to the proposed amendments. A total of two letters were received commenting on the proposed amendments. One letter was from a representative of CSB Asphalt, Inc. And the other was from a representative of Sand Supply, Inc. Both commentors supported the proposal. The Department agrees with the commentors that the rule amendments are needed. The proposed amendments increase the valid life of a marl, sand and gravel permit from the current one-year to a new three-years. Permits may be renewed at the end of the three-year period for an additional three-year period. Application, review and renewal fees have also been doubled in order to continue to provide revenue for monitoring and enforcement activities on permits. To permit holders, the principal costs of obtaining a permit are in the preparation of the application. The application process is complex enough to require up to one year's worth of preparation time to prepare before filing. Thus, some applicants, after receiving a one-year permit, must immediately begin preparing a renewal application for the next year. The proposed amendments will reduce the costs to permit holders by reducing the number of times they must prepare renewal applications. The increased fees will offset the loss of public fee revenue used for monitoring permit holders performance. Because the subject of the proposed amendments is in all cases public property and no restrictions are imposed by the regulations on the use of private property, there is no takings impact within the purview of the private Real Property Rights Preservation Act, (the Act) Chapter 2007 of the Government Code. Furthermore, there are no governmental actions allowed by the proposed regulations which fall under the purview of the definition of a "taking" in sec.2007.002(5) of the Act. The amendments are adopted under Parks and Wildlife Code sec.86.006 and sec.86.020 which authorize the Commission to establish rules for the terms and conditions of permits to remove marl, sand and gravel. Chapter 86 of the Parks and Wildlife Code authorizes the Commission to manage the marl, sand and gravel in state owned riverbeds. This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority. Issued in Austin, Texas, on November 24, 1997. TRD-9715831 Bill Harvey Regulatory Coordinator Texas Parks and Wildlife Department Effective date: December 15, 1997 Proposal publication date: October 3, 1997 For further information, please call: (512) 389-4642