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 25. HEALTH SERVICES PART I. Texas Department of Health CHAPTER 143.Medical Radiologic Technologists The Texas Department of Health (department) adopts amendments to sec.sec.143.2, 143.4-143.9, and new sec.sec.143.16, 143.19 and 143.20, concerning the regulation of persons performing radiologic procedures. Sections 143.2, 143.4, 143.7, 143.8, 143.9, 143.16, 143.19 and 143.20 are adopted with changes to the proposed text as published in the October 1, 1996, issue of the Texas Register (21 TexReg 9399). Section 143.5 and sec.143.6 are adopted without changes and therefore will not be republished. The amendments add a definition for cardiovascular; add fees for limited curriculum programs offered by accredited education programs and amendments to training programs; clarify the applicability of the rules and hardship exemptions; establish new and clarify existing application requirements and procedures; establish a new type of certificate and applicant eligibility; add a limited examination for the cardiovascular category; set out new procedures and strengthen the existing standards for the approval of curricula and instructors; identify dangerous or hazardous radiologic procedures; establish hardship exemption criteria and procedures; and establish alternative training requirements for registered nurses (RNs), physician assistants (PAs), and podiatric medical assistants (PMAs) who perform radiologic procedures. The amendments add a new limited certificate category for cardiovascular, provide administrative procedures that allow general certificate programs to qualify as limited curriculum programs, strengthen the rules related to limited certificate programs, provide an administrative procedure and require submission of fees for amending education programs, and update and clarify the existing rules. The sections as amended update the existing rules so they are consistent with new sections and new legislation, to provide pathways for qualified persons to obtain limited certificates in medical radiologic technology, to strengthen the regulation of limited certificate education programs and to recover the cost of administering the limited certificate education programs. New sec.143.16 covers dangerous or hazardous radiologic procedures which may be performed only by a practitioner or medical radiologic technologist (MRT), unless otherwise stated in the rule. This will assure that the public is protected from the harmful effects of radiation used for medical purposes by regulation specifying that certain procedures should only be performed by persons, such as practitioners, MRTs, limited medical radiologic technologists (LMRTs), RNs, PAs or PMAs who have additional medical or health care training and/or licensure over and above that of a non-certified technician (NCT). New sec.143.19 sets out the administrative procedures for applying for and granting hardship exemptions for hospitals, federally qualified health centers and practitioners. The criteria is intended to reflect the statutory language. By providing a procedure for approving bona-fide hardship exemptions from the regulations, this section should minimize the effect of the new regulations on access to care. It is important to note that a person or entity with an approved hardship exemption may not employ a person who is not a practitioner or MRT to perform the procedures listed as dangerous or hazardous in sec.143.16. New sec.143.20 establishes training requirements for RNs, PAs and PMAs which are an alternative to existing sec.143.17, Mandatory Training Programs for Non- Certified Technicians, adopted in June 1996. This section recognizes the post- secondary school education of RNs and PAs and specifies unique training requirements for persons who will x-ray only the foot and ankle. The particular training requirements for these groups are intended to minimize the possibility of redundant or unnecessary training. New sec.sec.143.16, 143.19 and 143.20 implement Acts 1995, 74th Legislature, Chapter 613 (House Bill 1200), which amends the Medical Radiologic Technologist Certification Act (Act), Texas Civil Statutes, Article 4512m. A summary of the comments received and the department's responses are as follows. Comment: Concerning sec.143.2, a comment was received indicating that the definition of "cardiovascular" was too broad, and speculated that cardiovascular technologists may expand their scope of practice to cover other parts of the circulatory system if the definition was adopted as proposed. Response: The department agrees and has amended the definition to clearly indicate that the cardiovascular category is limited to the coronary vessels, atria, ventricula, ascending aorta and aortic arch. Comment: Concerning sec.143.2, several comments were received in support of the definition of "cardiovascular" and the new limited certificate category of "cardiovascular" in sec.143.7, the recognition of the invasive cardiovascular technology exam in sec.143.8, and recognition of the cardiovascular curriculum in sec.143.9. Response: The department agrees and appreciates the support of the commenters. Comment: Concerning sec.143.2, a comment was received stating that pediatric radiologic procedures should be removed from sec.143.16 regarding dangerous or hazardous procedures, and the definition of "pediatric" should be removed from the rules. Response: The department has agreed to remove the definition of "pediatric" from sec.143.2. Future rule-making will be needed to address pediatric radiography training for NCTs in sec.143.17. Comment: Concerning sec.143.2, a comment was received stating that the wording of the definition of "pediatric" could be improved. Response: The department agrees. No changes were made based on the comment. The definition was removed from the rule altogether. Comment: Concerning sec.143.4, a comment was received asking if there was a fee for a currently approved training program which adds the new training requirements set out in sec.143.20. Response: The department agrees that a fee is needed and has amended sec.143.4, to add a training program amendment fee. Comment: Concerning sec.143.6(c)(2)(B)(iii)(I) and (II) which was proposed for deletion, a commenter questioned the prudence of deleting the subclauses. Response: The department agrees with the commenter and will retain the language. Comment: Concerning sec.143.7(f)(3), a comment was received indicating that there could be confusion as to the meaning of the first sentence. Response: The department agrees and has changed the wording of the first sentence in the paragraph. Comment: Concerning sec.143.8(d), a comment was received stating that a limited certificate is not issued upon successful completion of an examination. Rather, it is issued upon payment of a fee which is determined after the person passes an examination. Response: The department agrees and wording has been added to clarify the administrative procedure for issuing a limited certificate after a person passes the examination. Comment: Concerning sec.143.9(h) regarding instructor qualifications, a comment was received objecting to the new requirement for only classroom teaching experience as qualifying a person to be an approved limited curriculum instructor. Response: The department agrees with the commenter and has added wording to clarify that classroom or clinical instruction experience qualifies the person to be an approved instructor. Comment: Regarding sec.143.9, a comment was received questioning why the department had proposed the new limited category for cardiovascular technology because the preamble of the essentials and guidelines for the Joint Review Committee in Cardiovascular Technology (JRCCVT) stated it was not the intent that a cardiovascular technologist (CVT) expose patients to ionizing radiation. Response: No changes were made as a result of the comment. Testimony was provided to the department by the chairman of the JRCCVT explaining that in 1985 when the essentials and guidelines were developed, a representative of the American College of Radiology strongly advocated that the language be added to clarify that the professional education of CVTs was not intended to make radiologic technologists of them. In the intervening 12 years since the essentials were written, the technology had advanced and proliferated dramatically. Often the CVT makes the exposures in a cardiac catheterization laboratory, rather than the cardiologist or an MRT. Furthermore, the department will only issue a limited certificate in the cardiovascular category to CVTs. The department does not intend to make general radiographers out of CVTs. The department, however, acknowledges the formal training and credentialing examination for the cardiovascular category only. The limited medical radiologic technologist (LMRT) certificate issued in CVT does not authorize the performance of radiologic procedures of other anatomical parts. In order to do so, the person must complete the educational requirements for another LMRT category, or complete the educational requirements for the general certificate, or complete the training described in sec.143.17, relating to mandatory training programs for NCTs. Comment: Regarding sec.143.16, a comment was received asking whether chest radiography, which constitutes 20-45% of all radiographs taken according to the commenter, could be performed by anyone. Response: No changes were made based on the comment. Chest radiography may be performed by an NCT, MRT or LMRT-chest. Comment: Concerning sec.143.16, a commenter stated that the rules relating to all radiologic procedures should be the same as the rules relating to mammography. Response: The department disagrees and no changes were made to the rules as a result of the comment. Section 2.05(g) and (j) of the Act clearly indicate that the Texas Legislature intended for the department to recognize that there were radiologic procedures which could be performed by non-certified persons. Comment: Concerning sec.143.16, a comment was received recommending that dangerous or hazardous procedures be classified as Class A or Class B procedures, respectively, to avoid the perceived alarm at the terms "dangerous" and "hazardous." Response: The department agrees that the terms may have an undesirable connotation but did not accept the comments for changes to the rules. The classification suggested may further complicate or obfuscate the rules. The terms dangerous or hazardous are taken from the statutory language in sec.2.05(g). Comment: A comment was received regarding sec.143.16(b) indicating that NCTs should be permitted to perform dangerous procedures in JCAHO accredited or Medicare certified hospitals. Absent that allowance the commenter stated that the list should be reconsidered so that RNs and PAs be allowed to perform specific dangerous procedures, as they are today under the direction and supervision of a physician. Response: The department disagrees and no changes were made as a result of the first comment. Changes were made to sec.143.16(c)(5), (7), and (8) allowing an RN or PA to perform shoulder girdle radiography, sternum radiography and radiographs involving contrast media, while under the direction and supervision of a practitioner. Corresponding training will be required for the RNs and PAs who will perform the procedures. The additional training will be addressed in future rule-making. Training must be completed by January 1, 1998, or before performing the procedure after January 1, 1998. Comment:Concerning sec.143.16(b)(1), a comment was received requesting that diagnostic and therapeutic nuclear medicine procedures be separated so that diagnostic nuclear medicine procedures would be identified as "dangerous," and therapeutic nuclear procedures would be identified as "hazardous." Response: The department disagrees and no changes were made to the rules based on the comment. There appeared to be no benefit to separating the types of nuclear medicine procedures because procedures identified as either dangerous or hazardous may only be performed by a practitioner or MRT. There are specific dangerous or hazardous procedures which may be performed by LMRTs, RNs and PAs. Comment:Concerning sec.143.16(b)(2), a commented asked that the qualifier, "who is appropriately trained," be deleted. The commenter stated that the required training for RNs, and PAs is set out in sec.143.20 and is crossreferenced in sec.143.16(a). Response: The department disagrees and no changes were made to the rules based on the comment. The training specified in sec.143.20 does not cover dangerous or hazardous radiologic procedures identified in sec.143.16. The appropriate training for persons handling radioactive materials is determined by the department's Bureau of Radiation Control (BRC) and language was added to clarify this. Comment: Concerning sec.143.16(b)(4), a comment was received indicating that the rules should be changed to allow NCTs to perform, under physician direction and supervision, superficial radiotherapy (80 kilovolts) and grenz ray procedures (14 kilovolts) for dermatologic treatments. Response: The department disagrees and no changes were based on the comment. The rules of the Texas State Board of Medical Examiners (BME) do not authorize such procedures to be performed by registrants under 22 Texas Administrative Code (TAC), sec.193.7, adopted in 1989. These procedures may only be performed by practitioners, RNs or certified MRTs. The voltage mentioned in the comment for superficial radiotherapy is more than double mammographic voltage of 27 to 38 kVp. Mammography is a radiologic procedures which is regulated by the Mammography Quality Standards Act, and may only be performed by MRTs who have met additional qualifications. It is the training of the operators which impacts the safe administration to patients, not just the low voltages as emphasized by the commenter. Comment: Regarding sec.143.16(b)(6), a comment was received indicating that since RNs and PAs in the field today are performing fluoroscopy and fluorography, the rules should be changed to allow this to continue. Response: The department agrees with the comments as long as the procedures are performed under the direction and supervision of a practitioner. Changes were made to sec.143.16(c)(5), (7), and (8) allowing an RN or PA to perform shoulder girdle radiography, sternum radiography and radiographs involving contrast media, while under the direction and supervision of a practitioner. Corresponding training will be required for the RNs and PAs who will perform the procedures. The additional training will be addressed in future rule-making. Training must be completed by January 1, 1998, or before performing the procedure after January 1, 1998. Comment:A similar comment was received regarding sec.143.16(c) indicating that NCTs should be permitted to perform some hazardous procedures in JCAHO accredited or Medicare certified hospitals. Absent that allowance the list should be reconsidered so that RNs and PAs be allowed to perform specific procedures such as sternum radiographs, as they are today under the direction and supervision of a physician. Response: The department disagrees and no changes were made as a result of the first comment. Changes to the rules allowing RNs and PAs to perform sternum radiographs has already been covered. Comment: Concerning sec.143.16(c), a comment was received indicating that NCTs should be allowed to perform pediatric chest radiography and KUB's (kidney- urinary bladder) in JCAHO accredited hospitals because JCAHO makes sure that all radiographers have competency for "all age groups..." Response: The department partially disagrees and no changes were made as a result of the comments. Pediatric radiography was removed from the hazardous list; thus, pediatric chest radiography may be performed by NCTs. KUBs are radiologic procedures which require the use of contrast media. Sometimes sedation is required to obtain a good radiograph. Because of the potential of patient harm due to these additional requirements, contrast media procedures should remain on the list of hazardous procedures. Comment: Concerning sec.143.16(c), two commenters asked why oblique spine views could not be performed by NCTs when the rules allowed flexion and extension spine radiography. One commenter wanted oblique spines taken off the list of hazardous procedures and the other wanted flexion and extension views added to the list of hazardous procedures. Response: The department did not accept the comments for rule changes. Oblique spines are on the list of hazardous procedures due to the high degree of difficulty with positioning and technique, and the high exposure potential of this spinal radiograph. Comment: Concerning sec.143.16(c), a commenter asked why portable x-rays of the hand and chest were identified as hazardous. Response: Portable x-ray machines have a high potential for exposure of persons other than the patient or the technician. Portable x-ray machines, due to the fact that they are mobile, have a higher potential for needed adjustments and maintenance, which minimally trained personnel may not be aware of or may overlook. More training in radiation protection for the patients, self and others and equipment operation and maintenance is required for persons who perform mobile or portable radiography, and should only be performed by an MRT. Comment: Concerning sec.143.16(c)(3), a comment was received indicating that some physicians use hand-held, low voltage x-ray units for imaging the hand, forearm and elbow. The commenter stated that NCTs should be allowed to operate the specific model mentioned under the instruction and direction of a practitioner, and that the training should be minimal. Response: The department partially agrees. No changes were made as a result of the comment. Rules addressing specific types of equipment did not appear to be prudent as they might become quite lengthy, tedious and outdated repeatedly when new models are introduced and others are discontinued. In other words, the issue appears to be a "moving target." Should the U.S. Food and Drug Administration or the department's BRC determine a new classification for these devices or exempt these devices from state regulation, the issue could be addressed through future rule-making. However, the department agreed, on a trial basis, to add a "hardship exemption" to sec.143.19 for the specific unit used by the commenter for imaging upper extremities only. Comment: Several comments were received requesting that pediatric procedures be removed from the hazardous procedures list at sec.143.16(c)(4). The commenters asked that the restrictions for pediatric procedures match the restrictions for adult procedures. Response: The department agrees and has removed pediatric radiography, excluding extremities, from the rule identifying hazardous procedures. It is important to note here that future rule-making will be needed to address pediatric radiography training for NCTs in sec.143.17. Comment: A comment was received asking that all shoulder girdle radiographs be deleted from the list of hazardous procedures in proposed sec.143.16(c)(6). Response: The department disagrees and no changes were made to the rules as a result of the comments. There are significant difficulties in positioning for imaging the articulation of the shoulder girdle. The rule now found at sec.143.16(c)(5) allows four views of the shoulder at the present time: anterior-posterior (AP) and lateral shoulder views, AP scapula and AP clavicle. The rule as specified is necessary to protect the public from the hazardous of excessive radiation used for medical purposes. With reports indicating repeat exposure rates as high as 67% due to technical errors made by non-certified personnel, the department is very concerned about the impact on the public health. The department continues to receive concerns and complaints about radiographs of non-diagnostic quality which indicate the use of no collimation, wrong film size and poor positioning. Poor quality radiographs predispose physicians to misinterpretations and misdiagnoses. Furthermore, repeated x-rays result in higher costs and more radiation to the patients. The department urges the complainants to file complaints with the BME. Comments and responses have noted the RNs and PAs may perform shoulder girdle radiography. Comment: A commenter requested that proposed sec.143.16(c)(8) be changed to allow RNs and PAs to perform sternum radiographs under the instruction and direction of a practitioner. Response: The department agrees and has changed the rule now at sec.143.16(c)(7) to allow RNs and PAs to perform sternum radiographs under the direction and supervision of a practitioner. Caution must be exercised because the sternum is a major blood forming bone. The mammary glands are exposed during sternum radiography. Correct sternum radiography poses a high degree of difficulty in projections and in positioning the patient. Excessive radiation to this part of the body would be hazardous and has the potential of increasing morbidity and mortality. Comment: A commenter requested that proposed sec.143.16(c)(9) be changed to allow RNs and PAs to perform radiographic procedures which utilize contrast media if the procedure were performed under the instruction and direction of a physician certified in a medical specialty which utilized the procedure. Response: The department disagrees. No changes were made to the rule as proposed based on the comments. The suggested verbiage would create problems for radiation control inspectors, complaint investigations, and state-agency administrative staff. Furthermore, the verbiage could be misunderstood by physicians and their staff. The department does not plan to adopt rules which require checking or validating physicians' credentials. The department agreed to allow RNs and PAs to perform radiographic procedures utilizing contrast media under the direction and supervision of a practitioner in the rule now at sec.143.16(c)(8). Comment: A commenter suggested adding a new subsection to sec.143.16 which addresses the administrative procedure for identifying a dangerous or hazardous radiologic procedure. Response: The department disagrees and no changes were made to the rules as a result of the comment. The department believes there is no reason to reiterate statutory language from sec.sec.2.04(d), 2.05(g) and 2.05(k) in the administrative rules. Comment: Concerning the effective date of sec.143.16(i), a commenter recommended postponement of the effective date to allow a transition period for those who are required to comply. Response: The department agrees and has extended the effective date until June 1, 1997 in sec.143.16(i)(1). Comment: Regarding sec.143.16(i), a comment was received suggesting that additional wording was needed to address the effective date for the section as it applied to RNs or PAs before and after January 1, 1998. Response: The department agrees and added wording as to procedures performed before January 1, 1998, and those performed after that date. Before performing radiologic procedures on or after January 1, 1998, RNs or PAs must either complete training under sec.143.17 or sec.143.20, or a hardship exemption must be granted under sec.143.19. See sec.143.16(i)(2). Comment: Concerning sec.143.16(i), many comments were received asking that the effective date of the section be delayed as long as possible due to concerns about Attorney General Letter Opinion 96-077, issued in July 1996 regarding students performing dangerous or hazardous procedures as a part of the educational program approved under sec.2.05(f) of the Act. Response: The department disagrees. Following the issuance of another letter opinion on November 5, 1996, indicating the department could issue student certificates which would allow students to perform dangerous or hazardous procedures as a part of an educational program, further clarification was obtained from the Office of the Attorney General. The department added language in sec.143.16(j) which clarifies the specific circumstances in which students may perform dangerous or hazardous procedures. The department does not anticipate issuing student certificates at this time. Comment: Concerning sec.143.19(c)(4)(B), a comment was received indicating that a distance of 50 miles from a school of radiologic technology did not constitute a hardship and that a hardship existed only if the distance was in excess of 200 miles. Response: No changes were made as a result of the comment. In its original proposal published in the December 22, 1995, issue of the Texas Register, the department proposed a distance of 100 miles. Based on comments received in response to the earlier proposal supporting a lesser number of miles, the department reduced the distance for this subsequent proposal. Comment: A comment was received stating that the hardship exemption in sec.143.19(c)(4)(B) would not permit an applicant located less than 50 miles from a school to present extenuating circumstances as to why the distance is a hardship, when "the applicant and the school are separated by urban density of suburban sprawl so as to make travel between them a hardship." Response: The department disagrees and no changes were made to the rules on the basis of the comments. Fifty miles is an appropriate distance for a hardship. Comment: Concerning sec.143.19, comments were received indicating that there should be no hardship exemptions adopted. Response: No changes were made to the rules as a result of the comments. The department is adopting the rules relating to hardship exemptions in response to the statutory language in HB 1200. Comment: A comment was received concerning the language in sec.143.19(c)(4)(A). The commenter noted that the terms "comparable" and "area" were not defined. The commenter stated that entities will be unsure of their meaning. The commenter stated that the terms are unnecessary in rule-making. Response: The department disagrees with the comments and no changes were made to the rules based on the comments. Without the terminology, the department feels that entities could be jeopardized because a salary for an urban area is not a comparable salary for a rural area. Likewise, a comparable salary in rural west Texas might not be comparable for a rural area in south Texas. Should the terms be applied illogically once the department begins granting hardship exemptions, then perhaps the terminology will need to be revisited in future rule-making Comment: A comment was received asking that the last sentence in sec.143.19(c)(4)(A) be deleted. Otherwise, an applicant which needed to hire an MRT would have to submit an affidavit stating its inability to hire an LMRT. Response: The department disagrees with the rationale and no changes have been made as a result of the comment. The department believes that the language "or LMRT" is appropriate. The ability of the applicant to describe in narrative form its attempts to fill a vacancy may certainly include information relative to the duties to be performed, if pertinent. The department emphasizes that if granted a hardship exemption, the persons at that location could not perform radiologic procedures identified as dangerous or hazardous in sec.143.16. Comment: Regarding sec.143.19, several comments were received concerning the appropriate training requirements for persons performing bone densitometry utilizing x-radiation. The commenters asked that these procedures be exempt from the training requirements in sec.143.17. Response: The department agrees with the concerns and has added new language in sec.143.19(c)(4)(G) to address hardship exemptions for persons operating bone densitometry units. Comment: Regarding sec.143.19, a commenter stated the reasons why the training requirements in sec.143.17 were not appropriate for a particular hand-held fluoroscope utilized for imaging the upper extremities only. Response: The department agrees, on a trial basis, to consider granting a hardship exemption in this case, but is concerned that the rule will lead to future rule-making burdens addressed in sec.143.16. Language was added in sec.143.19(c)(4)(H) to address hardship exemptions for persons operating certain hand-held fluoroscopes for imaging upper extremities only. Comment: Comments were received asking that additional criteria be included in sec.143.19, which would allow for a hardship exemption to be granted due to the cost of the mandatory training (tuition, travel expenses, overtime pay and time away from practice), as set out in sec.143.17 adopted in June 1996, if a practitioner has determined the NCT to be competent. Response: The department agrees and two additional hardships (I) and (J) were added to sec.43.19(c)(4) as a result of the comments. Comment: Concerning sec.143.16 and sec.143.19, several commenters raised concerns about access to care. Response: The department partially agrees with the commenters. The impact on access to care is expected to be minimized by adjusting or rearranging job duties for non-certified persons who perform radiologic procedures identified as dangerous or hazardous in sec.143.16; practitioners performing radiologic procedures, as necessary, whenever a certified technologist, RN or PA is unavailable; allowing a variety of exemptions in documented hardship situations; and adopting specific training requirements for RNs, PAs, and PMAs. It is important to note that a practitioner or entity with an approved hardship exemption may not employ a person who is not a practitioner or MRT to perform a procedure listed in sec.143.16. There are specific radiologic procedures identified in sec.143.16 which an appropriately trained RN or PA may perform under the direction and supervision of a physician. Comment: Several commenters had questions concerning costs and accessibility of training programs. Response: The department agrees and strongly recommends the exercise of responsible consumer choice when selecting the training program which will best fulfill the needs of the trainee. The department is unable to offer or provide the training for RNs, PAs, PMAs or NCTs. The department urges practitioners, medical schools, educational programs, and technologists to proactively respond to the need for cost-effective training programs by setting up innovative training programs using distance learning vehicles. In addition, there are new hardship exemptions in sec.143.19(c)(4)(G)-(J). Minor editorial changes were made throughout the rules for clarification purposes and to improve grammar and style. The following provided comments on the proposed rules: Texas Academy of Family Physicians; Texas Academy of Physician Assistants; Texas Hospital Association; Texas Medical Association; Texas Nurses Association; Texas Osteopathic Medical Association; Texas Society of Radiologic Technologists; Texas Society of Plastic Surgeons; Texas Orthopedic Association; Texas Dermatological Society: El Centro College, Health and Legal Studies Division, Dallas County Community College District; Tyler Junior College; MASI Healthcare Services; Methodist Medical Center- Dallas; Houston Community College; Odessa College, Advanced Healthcare Education Center (AHEC); Austin Community College; Baylor College of Medicine; Blinn College; Houston Area Radiologic Technologist Society; Scott and White Clinic; Thomas Consulting; Baptist Hospital of Southeast Texas, School of Radiologic Technology; Del Mar College; Irving Healthcare System; Texas MedClinic; Scenic Mountain Medical Center, School of Radiologic Technology; Amarillo College; Midwestern State University; Texas Hand Center; Lakeland Medical Center; Marshall Regional Medical Center; The Family Doctors; Methodist Hospital-Lubbock; South Plains College; East Texas Society of Radiologic Technologists; Kilgore College; Presbyterian Hospital-Winnsboro; University of Texas Health Science Center - San Antonio; GSMC Medical Imaging; Medical Physics Consultants; and department staff. While none of the commenters were against the rules in their entirety, they expressed concerns, questions and made recommendations. 25 TAC sec.sec.143.2, 143.4-143.9, 143.19, 143.20 The amendments and new sections are adopted under the Medical Radiologic Technologist Certification Act, Texas Civil Statutes, Article 4512m, sec.2.05(e), which provide the Texas Board of Health (board) with the authority to adopt rules necessary to implement the Act; sec.2.05(a), concerning rules on certificates, education programs, instructors, and the registry; sec.2.05(f), concerning minimum standards for mandatory training; sec.2.09, concerning rules on applications for certificates and approval of curricula, training programs, and instructors; and the Texas Health and Safety Code, sec.12.001, which provides the board with the authority to adopt rules for the performance of every duty imposed by law on the board, the department, and the commissioner of health. sec.143.2.Definitions. The following words and terms, when used in this chapter, shall have the following meanings, unless the context clearly indicates otherwise. Cardiovascular (CV)-Limited to the coronary vessels, atria, ventricula, ascending aorta and aortic arch. sec.143.4.Fees. (a) (No change.) (b) The schedule of fees is as follows: (1)-(16) (No change.) (17) training program application fee-$350; (18) training program amendment fee-$40; (19) training program renewal fee-$150; (20) limited curriculum amendment fee-$40; and (21) annual limited curriculum approval fee for general certificate programs - $225. sec.143.7.Types of Certificates and Applicant Eligibility. (a)-(c) (No change.) (d) Minimum eligibility requirements for certification. The following requirements apply to all individuals applying for certification who do not meet the requirements of subsections (b) or (c) of this section: (1)-(5) (No change.) (6) eligibility for the specific certificate requested as set out in subsections (e), (f), (g), (h), or (i) of this section. (e) (No change.) (f) Limited medical radiologic technologist. To qualify for a limited certificate, an applicant shall meet the requirements in paragraph (4) of this subsection and subsection (d) of this section. (1) The limited categories shall be as follows: skull; chest; spine; extremities; chiropractic; podiatry; and cardiovascular. (2) (No change.) (3) Persons holding a limited certificate in one or more categories may not perform radiologic procedures involving the use of contrast media, utilization of fluoroscopic equipment, mammography, tomography, bedside radiography, nuclear medicine, and/or radiation therapy procedures. However, a person holding a limited certificate in the cardiovascular category may perform radiologic procedures involving the use of contrast media and fluoroscopic equipment for the purposes of diagnosing or treating a disease or condition of the cardiovascular system. (4) To qualify for a certificate as an LMRT an applicant must provide documentary evidence satisfactory to the department of the following: (A) (No change.) (B) current licensure or registration as an LMRT by another state, District of Columbia, or territory of the United States of America whose requirements are more stringent than or substantially equal to the requirements for the Texas limited certificate at the time of application to the department; or (C) current general certification as an MRT issued by the department. The MRT must surrender the general certificate and submit a written request for a limited certificate indicating the limited categories requested. The request shall be postmarked on or before the certificate expiration date and shall be accompanied by the general certificate and the certificate and/or identification card replacement fee. (g) Temporary medical radiologic technologist (general). To qualify as a temporary medical radiologic technologist (general), an applicant shall meet at least one of the following requirements. These are in addition to those listed in subsection (d) of this section. For the general temporary certificate, an applicant must: (1) have successfully completed or be within 28 calendar days of successful completion of a course of study in radiography, radiation therapy technology, or nuclear medicine technology which is accredited by the Committee on Allied Health Education and Accreditation (CAHEA); (2) be approved by the ARRT as examination eligible; (3) be approved by the NMTCB as examination eligible; or (4) be currently licensed or otherwise registered as an MRT by another state, District of Columbia, or territory of the United States whose requirements are not substantially equal to the Texas requirements for certification at the time of application to the department. (h) Temporary limited medical radiologic technologist. The applicant shall meet at least one of the following requirements. These are in addition to those listed in subsection (d) of this section. The applicant must: (1) have successfully completed or be within 28 calendar days of successful completion of a limited certificate program in the categories of skull, chest, spine, abdomen or extremities, which is approved in accordance with sec.143.9(c) of this title (relating to Standards for the Approval of Curricula and Instructors); (2) be currently enrolled in a course of study in a general certificate program approved in accordance with sec.143.9(b) of this title (relating to Standards for the Approval of Curricula and Instructors) and have been issued a certificate of completion by the program signifying that the person has completed classroom instruction, clinical instruction, evaluations and competency testing in all areas included in the limited curriculum, as set out in sec.143.9(e) of this title; or (3) be licensed or registered as an LMRT by another state, District of Columbia, or territory of the United States whose requirements are not substantially equal to the Texas requirements for certification at the time of application to the department. (i) Special provisions for technologists on active military duty. An MRT or LMRT whose certificate has expired and was not renewed under sec.143.10(h) of this title (relating to Certificate Issuance, Renewals, and Late Renewals) may file a complete application for another certificate of the same type as that which expired. (1) The application shall be on official department forms and be filed with the application processing fee. (2) An applicant shall be entitled to a certificate of the same type as that which expired based upon the applicant's previously accepted qualification and no further qualifications or examination shall be required except payment of the certification fee. (3) The application must include a copy of the official orders or other official military documentation showing that the holder was on active duty during any portion of the period for which the applicant was last certified. (4) An application is subject to disapproval in accordance with sec.143.6(e) of this title (relating to Application Requirements and Procedures). (5) An applicant for a different type of certificate than that which expired must meet the requirements of this chapter generally applicable to that type of certificate. (j) Alternate eligibility. An individual who does not qualify under subsections (a)-(i) of this section may qualify under sec.143.15 of this title (relating to Alternate Eligibility Requirements). sec.143.8.Examinations. (a)-(c) (No change.) (d) Approved examination for the limited certificate. An approval letter requesting the limited certification fee shall be issued upon successful completion of the appropriate examination, as follows: (1)-(4) (No change.) (5) chiropractic-the ARRT examinations for the limited scope of practice in radiography (spine and extremities); (6) podiatric-the ARRT examination for the limited scope of practice in radiography (podiatry); or (7) cardiovascular-the Cardiac Credentialing International invasive registry examination. (e)-(i) (No change.) sec.143.9.Standards for the Approval of Curricula and Instructors. (a)-(b) (No change.) (c) Limited certificate programs. All curricula and programs to train individuals to perform limited radiologic procedures must: (1) be accredited by the JRCERT to offer a limited curriculum in radiologic technology; (2) be accredited by the Joint Review Committee for Cardiovascular Technology (JRCCVT) to offer a curriculum in invasive cardiovascular technology; (3) be accredited by JRCERT under subsection (b) of this section; or (4) be approved by the department and be offered within the geographic limits of the State of Texas. Subsections (d)-(h) of this section apply only to department-approved programs. (d) Application procedures for limited certificate programs which are not accredited by JRCERT or JRCCVT. An application shall be submitted to the department at least ten weeks prior to the starting date of the program to be offered by a sponsoring institution. Official application forms are available from the department and must be completed and signed by the program director of the sponsoring institution's program. Program directors shall be responsible for the curriculum, the organization of classes, the maintenance and availability of facilities and records, and all other policies and procedures related to the program or course of study. (1)-(5) (No change.) (6) The application shall include: (A)-(D) (No change.) (E) a list of clinical facilities, written agreements on forms prescribed by the department from clinical facilities signed by the program director and the chief executive officer(s) of each facility, and clinical schedules, including the following items identified for each clinical site utilized. A clinical facility which is not listed on the application may not be utilized for a student's clinical practicum until the department has accepted the additional clinical facility in accordance with paragraph (10) of this subsection. The items are: (i)-(v) (No change.) (vi) copies of the current identification cards issued by the department to the LMRTs or MRTs who will supervise the students at all times while performing radiologic procedures; (vii) an acknowledgement that the students in a limited curriculum program in the categories of skull, chest, spine, abdomen, extremities, chiropractic or podiatric shall not perform procedures utilizing contrast media, mammography, fluoroscopy, tomography, nuclear medicine studies, radiation therapy or other procedures beyond the scope of the limited curriculum; and (viii) an acknowledgement that the students in a limited curriculum program in the cardiovascular category shall not perform mammography, tomography, nuclear medicine studies, radiation therapy or other procedures beyond the scope of the limited curriculum. Such students may only perform radiologic procedures of the cardiovascular system which involve the use of contrast media and fluoroscopic equipment. (F) clearly defined and written policies regarding admissions, costs, refunds, attendance, disciplinary actions, dismissals, re-entrance, and graduation which are provided to all prospective students prior to registration and by which the program director shall administer the program. The admission requirements shall include the minimum eligibility requirements for certification in accordance with sec.143.7(c)(1)-(2) of this title (relating to Types of Certificates and Applicant Eligibility). (G)-(J) (No change.) (7) (No change.) (8) In making application to the department, the program director shall agree in writing to: (A)-(E) (No change.) (F) keep an accurate record of each student's attendance and participation, evaluation instruments and grades, clinical experience including radiation exposure history, and subjects completed for not less than five years from the last date of the student's attendance. Such records shall be made available to examining boards, regulatory agencies, and other appropriate organizations, if requested; (G)-(J) (No change.) (9) (No change.) (10) Following program approval, a written request(s) for amendment(s) shall be submitted to and approved by the department in advance of taking the anticipated action. The request to add or drop an instructor, clinical site, category of instruction, program director or other change, shall be accompanied by the limited curriculum program amendment application and fee in accordance with sec.143.4 of this title (relating to Fees). (e)-(f) (No change.) (g) Instructor approval for limited certificate programs. (1) All persons who plan to or who will provide instruction and training in the limited certificate courses of study or programs shall: (A)-(C) (No change.) (2)-(4) (No change.) (h) Instructor qualifications for limited certificate programs. (1) An instructor(s) shall have education and not less than six months classroom or clinical experience teaching the subjects assigned, shall meet the standards required by a sponsoring institution, if any, and shall meet at least one or more of the following qualifications: (A)-(C) (No change.) (2) (No change.) (i) Transition. Limited certificate programs approved as of June 28, 1996, shall have one year to comply with the requirements adopted on June 28, 1996. Limited certificate programs approved after June 28, 1996, shall comply with the requirements in effect at the time of application to the department. (j) Application procedures for limited certificate programs accredited by JRCERT or JRCCVT. (1) Application shall be made by the program director on official forms available from the department. (2) The application must be notarized and shall be accompanied by the following items: (A) the limited curriculum application fee, in accordance with sec.143.4 of this title (relating to Fees); (B) a copy of the current accreditation issued to the program by the JRCERT; (C) a description in narrative and/or table format clearly indicating that the curriculum of the general certificate program and the sequencing of the curriculum are equal to the limited certificate curriculum; and (D) an agreement to allow the department to conduct an administrative audit of the program to determine compliance with this section. sec.143.19.Hardship Exemptions. (a) Purpose. The purpose of this section is to set out the procedure for applying for a hardship exemption under the Medical Radiologic Technologist Certification Act (Act), sec.2.05(i) and (j) for a hospital, federally qualified health center (FQHC), or practitioner. (b) General. (1) A hospital, FQHC or practitioner may apply to the Texas Department of Health (department) for an exemption from employing a medical radiologic technologist (MRT), limited medical radiologic technologist (LMRT), or non-certified technician (NCT). (2) The applicant must demonstrate a hardship as described in subsection (c)(4) of this section in employing an MRT, LMRT, or NCT. (3) The applicant shall not allow a person who is not an MRT, LMRT, or NCT to perform a radiologic procedure until the department grants a hardship exemption. (4) A hardship exemption granted by the department does not constitute licensure, certification, registration, or authorization to perform a dangerous or hazardous radiologic procedure or mammography. (c) Required application materials. (1) The applicant must apply for a hardship on the forms prescribed by the department. The date of application shall be the date the application is postmarked. If there is no visible postmark, or if the application is hand- delivered, the application date shall be the date the administrator received the application. (2) The application must be accompanied by documentation clearly indicating that the applicant is a licensed hospital, FQHC or licensed practitioner. A copy of the current hospital license, certificate of qualification issued to the FQHC, or current license of the practitioner shall be acceptable documentation. (3) If the application is from a hospital or FQHC, the administrator or chief executive officer of the hospital or FQHC must sign the application form. If the applicant is a practitioner, the practitioner must sign the application form. (4) The application shall be accompanied by one or more of the following: (A) if the applicant is unable to attract or retain an MRT or LMRT, a sworn affidavit describing in narrative form the applicant's attempts to attract and retain an MRT or LMRT at a comparable salary for the area; (B) if the applicant is located more than 50 highway miles from the nearest school of medical radiologic technology approved in accordance with sec.143.9 of this title (relating to Standards for the Approval of Curricula and Instructors), a sworn affidavit describing in narrative form the physical address of the nearest school of medical radiologic technology; the physical address of the applicant hospital, FQHC, or primary practice location of the practitioner; and the actual distance in highway miles between the school and the applicant hospital, FQHC, or practitioner's primary practice. The applicant shall include a map of the area clearly indicating the locations of each entity; (C) if the nearest school of medical radiologic technology approved in accordance with sec.143.9 of this title (relating to Standards for the Approval of Curricula and Instructors) has a waiting list of school applicants due to a lack of faculty or space, a sworn affidavit from the applicant indicating that admissions to the school are pending because of a lack of faculty or space; (D) if the need for graduates in medical radiologic technology of the applicant exceeds the number of graduates from the nearest school of medical radiologic technology approved in accordance with sec.143.9 of this title, a sworn affidavit from the applicant indicating that the number of graduates from the nearest school does not meet the applicant's needs for radiologic technologists; (E) if emergency conditions have occurred during the 90 days prior to making application for the hardship exemption, a sworn affidavit from the applicant describing the emergency conditions, the hardship(s) the emergency conditions have created and how long the hardship(s) is anticipated to continue. For the purposes of this subparagraph, emergency conditions may include a disaster, epidemic, or other catastrophic event; (F) documentation that the United States government has declared a state of war; (G) if the equipment operated is a bone densitometry unit(s) which utilizes x- radiation, a sworn affidavit from the applicant indicating the name of the person operating the equipment and proof that the person has completed at least 20 hours of training as follows: (i) specific bone densitometry equipment utilizing x-radiation to be used by the operator-16 hours presented by a medical radiologic technologist (MRT) or an equipment applications specialist knowledgeable of the specific equipment to be utilized; and (ii) radiation safety and protection for the patient, self and others - 4 hours presented by an MRT or a licensed medical physicist within the 24-month period prior to application or reapplication for a hardship exemption; (H) if the applicant uses only a hand-held fluoroscope with a maximum operating capability of 65 kilovolts and 1 milliampere, or a similar type of x-ray unit for imaging upper extremities only, at the location indicated on the application form and the applicant believes that the radiation produced by the radiographic equipment represents a minimal threat to the patient and the operator of the equipment, the following is required to be submitted: (i) a copy of the current certificate of registration issued by the Bureau of Radiation Control; and (ii) a sworn affidavit describing the equipment used; the types of radiographs performed; the training completed by the operator of the equipment within the 24-month period prior to application or reapplication for a hardship exemption; the date(s) the training was completed by the operator; the radiation safety measures taken for the patient, operator and others; the level or amount of supervision provided by an MRT or a practitioner(s) to the operator while performing the radiographic procedure; and the equipment manufacturer's specifications for the diagnostic radiographic equipment utilized at the location indicated on the application form, including the maximum operating capability; (I) if the applicant employs, for the purpose of performing radiologic procedures, a person registered in accordance with rules adopted under sec.2.08 of the Act on or before January 1, 1998, a sworn affidavit indicating the name(s) of the person(s) and proof that the person(s) was registered on or before January 1, 1998. Such affidavit shall be on a form attesting that the training under sec.143.17 or sec.143.20 of this title (relating to Medical Radiologic Technologists) causes a fiscal hardship for the applicant. The affidavit shall include a statement that the person(s) performing radiologic procedures is adequately supervised and trained for the procedures being performed. If the applicant is a practitioner or FQHC, the person who will perform radiologic procedures must be registered in accordance with rules adopted under sec.2.08 of the Act at the time of application for the hardship exemption. If the person who will perform radiologic procedures is not an RN, the name of the practitioner for whom the radiologic procedures are performed, as named on the current registration permit, shall match the name or location of the applicant for whom the hardship is granted; or (J) if the applicant is a hospital accredited by the Joint Commission on the Accreditation of Health Care Organizations or which participates in the federal Medicare cost reimbursement program, an original letter on hospital letterhead stating the name(s) of the person(s) performing radiologic procedures in compliance with sec.2.07(d) of the Act on or before January 1, 1998. The letter shall be accompanied by a sworn affidavit from the applicant attesting that the training under sec.143.17 or sec.143.20 of this title causes a fiscal hardship for the applicant. The affidavit shall include a statement that the person(s) performing radiologic procedures is adequately supervised and trained for the procedures being performed. (5) All application materials and information are subject to verification by the department. (6) The department shall send a written notice listing the additional materials required to an applicant whose application is incomplete. An application not completed within 30 days after the date of the written notice shall be invalid unless the applicant has advised the department of a valid reason for the delay. (d) Application approval. (1) The administrator shall be responsible for reviewing all applications. The administrator shall approve any application which is in compliance with this section and which properly documents applicant eligibility. (2) If granted by the department, a letter of exemption shall be issued for a period of one year. (e) Disapproved applications. (1) The department shall disapprove the application if the applicant has not met the application requirements set out in this section or has failed or refused to complete or submit any form or documentation required by the department to verify the eligibility for the exemption. (2) If the administrator determines that the application should not be approved, the administrator shall give the applicant written notice of the reason for the disapproval. The applicant may appeal the decision to the associate commissioner over the administrator by submitting a written request within ten days after receipt of the written notice of the reason(s) for the disapproval. (3) Based upon the application and any additional information submitted by the applicant or the administrator, the associate commissioner shall approve or disapprove the application. (4) An applicant whose application has been disapproved under this subsection shall be permitted to reapply after a period of not less than one year from the date of the disapproval and shall submit a new application and supporting information. The applicant may reapply for an exemption anytime the basis for the exemption application changes. (f) Application processing. The department shall use the same process as described in sec.143.6(f) of this title (relating to Application Requirements and Procedures), except the time periods are as follows: (1) letter of acceptance-30 days; (2) letter of application deficiency-30 days; (3) letter of approval-42 days; and (4) letter of denial of exemption-42 days. (g) Reapplication for hardship exemption. (1) The hospital, FQHC, or a practitioner must reapply annually for the exemption and meet the then current requirements for a hardship exemption. (2) A hospital, FQHC, or a practitioner who does not reapply for an exemption shall not allow a person to perform a radiologic procedure unless the person is a practitioner, MRT, LMRT, or NCT. sec.143.20.Alternate Training Requirements. (a) Purpose. The purpose of this section is to set out the minimum standards for registered nurses (RNs), physician assistants (PAs) and podiatric medical assistants (PMAs). (b) Instructor direction required. All hours of the training program completed for the purposes of this section must be live and interactive and directed by an approved instructor. Distance learning activities and audiovisual teleconferencing may be utilized, provided these include two-way, interactive communications which are broadcast or transmitted at the actual time of occurrence. Appropriate on-site supervision of persons participating in the distance learning activities or teleconferencing shall be provided by the approved training program. No credit will be given for training completed by self-directed study or correspondence. (1) Effective January 1, 1998, before an RN or PA performs a radiologic procedure, the RN or PA must complete the hours stated in subsection (d) of this section, or the hours stated in sec.143.17 of this title (relating to Mandatory Training Programs for Non-Certified Technicians). (2) Effective January 1, 1998, before a PMA performs a radiologic procedure, the PMA must complete the hours stated in subsection (e) of this section, or the hours stated in sec.143.17(d) of this title (relating to podiatric radiologic procedures). (3) Individuals who complete training approved under this section may not use that training toward the educational requirements for a general or limited certificate as set out in sec.143.7 of this title (relating to Types of Certificates and Eligibility). (c) Approved instructors. (1) For purposes of this section, an individual is approved by the Texas Department of Health (department) to teach in a training program if the individual meets the requirements of sec.143.9(h)(1)-(2) of this title (relating to Standards for the Approval of Curricula and Instructors). The application for the training program must demonstrate that the instructors meet the qualifications. No application for individual instructor approval is required. (2) A limited medical radiologic technologist (LMRT) may not teach, train, or provide clinical instruction in a portion of a training program which is different from the LMRT's level of certification. For example, an LMRT holding a limited certificate in the chest and extremities categories may not participate in the portion of a training program relating to radiologic procedures of the spine. The LMRT may participate in the portions of the training program which are of a general nature and those specific to the specific categories on the limited certificate. (d) Training requirements for registered nurses and physician assistants. A training program preparing RNs and PAs to perform radiologic procedures shall be designed to build on the health care knowledge base and skills acquired through completion of an educational program that qualifies the person for licensure as an RN or PA. The training shall consist of: (1) a minimum of 32 classroom hours of coursework that are fundamental to diagnostic radiologic procedures covering all of the following items: (A) radiation safety and protection for the patient, self, and others-10 classroom hours; (B) radiologic equipment-10 classroom hours; (C) image production and evaluation-10 classroom hours; and (D) methods of patient care and management essential to radiologic procedures, excluding CPR, BCLS, ACLS and similar subjects-two classroom hours; and (2) one or more of the following units of classroom instruction in radiologic procedures: (A) chest and abdomen (non-pediatric)-eight classroom hours; (B) spine (non-pediatric)-eight classroom hours; (C) skull (non-pediatric)-eight classroom hours; (D) extremities (including pediatric)-eight classroom hours; and (3) if the RN or PA will perform pediatric radiologic procedures other than extremities, a minimum of two classroom hours for each of the areas identified in paragraph (2)(A)-(C) of this subsection. (e) Training requirements for podiatric medical assistants. (1) In order to successfully complete a program, a PMA must complete the following training: (A) radiation safety and protection for the patient, self, and others-10 classroom hours; (B) radiographic equipment used in podiatric medicine, including safety standards, operation, and maintenance-3 classroom hours; (C) podiatric radiologic procedures, imaging production and evaluation - 5 classroom hours; and (D) methods of patient care and management essential to radiologic procedures, excluding CPR, BCLS, ACLS and similar subjects-2 classroom hours. (2) Successful completion of PMA training allows the PMA to perform radiologic procedures only under the instruction or direction of a podiatrist. (f) Application procedures for training programs. The Texas Department of Health (department) shall use the same process as described in sec.143.17(e) of this title. (g) Application materials. The department shall require the same materials as described in sec.143.17(f) of this title. (h) Application approval. The department shall use the same process as described in sec.143.17(g) of this title. (i) Application processing. The department shall use the same process as described in sec.143.17(h) of this title. (j) Renewal. The department shall use the same process as described in sec.143.17(i) of this title. (k) Previously completed training. A person who has completed part or all of the training described in subsections (d) or (e) of this section shall be considered to have completed an approved training program for part or all of the training but shall be required to complete the remainder of the training program described in subsections (d) or (e) of this section prior to the person's placement on the registry, as set out in sec.143.18 of this title (relating to Registry of Non-Certified Technicians). (1) Unless the person is an RN or PA, the previously completed training shall be acceptable only if completed within two years of the time of the person's initial placement on the registry. (2) Previously completed training shall be acceptable only if it was: (A) completed at an education program approved under sec.143.9 of this title (relating to Standards for the Approval of Curricula and Instructors) or sec.143.17 of this title; (B) live, inter-active, and instructor-directed and meets the requirements for acceptance as continuing education credit for medical radiologic technologists or LMRTs as set out in sec.143.11 of this title (relating to Continuing Education Requirements); or (C) accepted for continuing education credits by the Board of Nurse Examiners. (3) If a person has completed part of the training described in subsections (d) or (e) of this section, the program director of the training program shall verify that the previously completed hours comply with this section. (4) If a person has completed all of the training described in subsections (d) or (e) of this section, the department shall verify that the previously completed hours comply with this section at the time of the person's placement on the registry. (5) Verification of previously completed training shall be made by reviewing only original certificates, official transcripts, printed course curriculum, syllabi, outlines or other documentation acceptable to the department issued in the name of the person who is seeking credit for previously approved training. Photocopied certificates or transcripts will be not accepted for review. (6) This subsection shall expire on January 1, 1998. 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 March 4, 1997. TRD-9703011 Susan K. Steeg General Counsel Texas Department of Health Effective date: March 24, 1997 Proposal publication date: October 1, 1996 For further information, please call: (512) 458-7236 25 TAC sec.143.16 The new section is adopted under the Medical Radiologic Technologist Certification Act, Texas Civil Statutes, Article 4512m, sec.2.05(e), which provide the Texas Board of Health (board) with the authority to adopt rules necessary to implement the Act; sec.2.05(a), concerning rules on certificates, education programs, instructors, and the registry; sec.2.05(f), concerning minimum standards for mandatory training; sec.2.09, concerning rules on applications for certificates and approval of curricula, training programs, and instructors; and the Texas Health and Safety Code, sec.12.001, which provides the board with the authority to adopted rules for the performance of every duty imposed by law on the board, the department, and the commissioner of health. sec.143.16.Dangerous or Hazardous Procedures. (a) Purpose. The purpose of this section is to identify the radiologic procedures which are dangerous or hazardous and may only be performed by a practitioner, medical radiologic technologist (MRT) or limited medical radiologic technologist (LMRT). There are specific procedures identified in subsections (b) and (c) of this section which may be performed by a registered nurse (RN) or a certified physician assistant (PA) trained under sec.143.17 of this title (relating to Mandatory Training Programs for Non-Certified Technicians) or sec.143.20 of this title (relating to Alternative Training Programs). A person trained under sec.143.17 or sec.143.20 of this title (relating to Medical Radiologic Technologies) and placed on a registry under sec.143.18 of this title (relating to Registry of Non-Certified Technicians) is not an MRT, LMRT or otherwise certified under the Medical Radiologic Technologist Certification Act (Act) and shall not perform a dangerous or hazardous procedure identified in this section unless expressly permitted under this section. (b) Dangerous procedures identified. Unless otherwise noted, the list of dangerous procedures which may only be performed by a practitioner or MRT are: (1) nuclear medicine studies; (2) administration of radio-pharmaceuticals, unless performed by an RN or PA who is appropriately trained as authorized by the department's Bureau of Radiation Control for licensure of radioactive materials; (3) radiation therapy, including brachytherapy; (4) computed tomography (CT) or any variation thereof; (5) interventional radiographic procedures, including angiography, unless performed by an LMRT with a certificate issued in the cardiovascular category; (6) fluoroscopy and/or fluorography, unless performed by an LMRT with a certificate issued in the cardiovascular category, or by an RN or PA who performs the procedure under the direction and supervision of a practitioner; and (7) cineradiography, unless performed by an LMRT with a certificate issued in the cardiovascular category. (c) Hazardous procedures identified. Unless otherwise noted, the list of hazardous procedures which may only be performed by a practitioner or MRT are: (1) conventional tomography; (2) skull radiography, excluding anterior-posterior/posterior-anterior (AP/PA), lateral, Townes, Caldwell, and Waters views; (3) mobile radiography; (4) spine radiography, excluding AP/PA, lateral and lateral flexion/extension views; (5) shoulder girdle radiographs, excluding AP and lateral shoulder views, AP clavicle and AP scapula, unless performed by an RN or PA who performs the procedure under the direction and supervision of a practitioner; (6) pelvic girdle radiographs, excluding AP or PA views; (7) sternum radiographs, unless performed by an RN or PA who performs the procedure under the direction and supervision of a practitioner; and (8) radiographic procedures which utilize contrast media, unless performed by an RN or PA who performs the procedure under the direction and supervision of a practitioner. (d) Performance of a hazardous procedure by an LMRT. An LMRT may perform a radiologic procedure listed in subsection (c) of this section only if the procedure is within the scope of the LMRT's certification, as described in sec.143.7(f) of this title (relating to Types of Certificates and Applicant Eligibility). (e) Performance of a dangerous or hazardous procedure by a practitioner. This section does not authorize a practitioner to perform a radiologic procedure which is outside the scope of the practitioner's license. (f) Dental radiography. This section does not apply to a radiologic procedure involving a dental x-ray machine, including panarex or other equipment designed and manufactured only for use in dental radiography. (g) Mammography. In accordance with the Health and Safety Code, sec.401.421 et seq, mammography is a radiologic procedure which may only be performed by an MRT (not an LMRT) who meets the qualifications set out in sec.289.230(d)(2) of this title (relating to Mammography). Mammography shall not be performed by a practitioner, an LMRT, an NCT, or any other person. (h) Prohibited act. A person who performs a dangerous or hazardous procedure in violation of the Act, sec.2.13(a)(1) commits a Class B misdemeanor, punishable by up to 180 days in jail or a fine up to $2,000, or both. (i) Effective date. (1) This section shall become effective on June 1, 1997. (2) Until January 1, 1998, an RN or PA may perform procedures listed in subsections (b)(2), (b)(6), (c)(5), (c)(7), or (c)(8) of this section under the direction and supervision of a practitioner. On or after January 1, 1998, an RN or PA must be trained under sec.143.17 or sec.143.20 of this title, or have been approved to perform radiologic procedures under a hardship exemption granted under sec.143.19 of this title (relating to hardship exemptions), in addition to performing the listed procedure under the direction and supervision of a practitioner. (j) Student performance of dangerous or hazardous procedures. The procedures identified in this section are not considered dangerous and hazardous for purposes of sec.2.05(g) of the Act if the person performing the procedures is a student enrolled in a program which meets the minimum standards adopted under sec.2.05 of the Act and if the person is performing radiologic procedures in an academic or clinical setting as part of the program. Therefore, such students may perform these procedures in such settings. Students may not perform procedures in an employment setting. 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 March 4, 1997. TRD-9703010 Susan K. Steeg General Counsel Texas Department of Health Effective date: March 24, 1997 Proposal publication date: October 1, 1996 For further information, please call: (512) 458-7236 PART II. Texas Department of Mental Health and Mental Retardation CHAPTER 406.ICF/MR Programs SUBCHAPTER B.Contracting Requirements 25 TAC sec.sec.406.51-406.67 The Texas Department of Mental Health and Mental Retardation (TDMHMR) adopts the repeal of existing sec.sec.406.51-406.67 of Chapter 406, Subchapter B, governing Contracting Requirments . The repeal accommodates the contemporaneous proposal of new sec.sec.406.51-406.67 in this issue of the Texas Register. Existing sec.sec.406.51-406.67 are repealed without changes to the proposed text as published in the December 24, 1996, issue of the Texas Register (21 TexReg 12362). The repeals would enable the addition of new sections to Chapter 406, Subchapter B. There was no oral or written testimony regarding the repeal at a public hearing held on January 13, 1997. The repeals are adopted under the Health and Safety Code, sec.532.015(a), relating to Rules and Policies, which provides the Texas Mental Health and Mental Retardation Board with broad rulemaking authority; and under the provisions of Texas Government Code, sec.531.021, relating to Administration of Medicaid Programs, which provides the Texas Health and Human Services Commission with the authority to administer federal medical assistance funds. The repealaffects Texas Human Resources Code, sec.sec.32.001- 32.040, relating to General Provisions, and Texas Government Code, sec.531.021, relating to Administration of Medicaid Programs. 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 March 5, 1997. TRD-9703057 Ann Utley Chairman, Texas MHMR Board Texas Department of Mental Health and Mental Retardation Effective date: March 25, 1997 Proposal publication date: December 24, 1997 For further information, please call: (512) 206-4516 The Texas Department of Mental Health and Mental Retardation (TDMHMR) adopts new sec.sec.406.51-406.67 of Chapter 406, Subchapter B, governing Contracting Requirements. Sections 406.51, 406.53, 406.57 and 406.61-406.67 are adopted with changes to the proposed text as published in the December 24, 1996, issue of the Texas Register (21 TexReg 12362). Sections 406.52, 406.54-406.56, and 406.58- 406.60 are adopted without changes. Existing sec.sec.406.51-406.67 are contemporaneously repealed in this issue of the Texas Register. The new sections remove the one-half mile location requirement for ICFs/MR and delete programmatic requirements that are no longer applicable to the ICF/MR provider application process. Minor changes were made throughout the subchapter to consolidate information, provide or correct references, and correct grammatical usage. In sec.406.51(c)(5), clarifying language was added and the term "individual's guardian" was changed to "guardian of the estate." In sec.406.51(c)(10), clarifying language was added addressing an individual's right to make decisions concerning his/her medical care and formulate advance directives. In sec.406.53(d), clarifying language was added addressing an extensions for applicants in obtaining certification. In sec.406.61, language was deleted which allowed contract termination if the department determined it was in its best interest. A public hearing was held on January 13, 1997, no testimony was presented. Written comments were received from Private Provider Association of Texas, Austin and the Reimbursement Advisory Panel of TDMHMR, Austin. Two commenters requested that all references to "resident" be changed to "consumer." The department responds by making the requested modifications. Regarding sec.406.51(c)(5), two commenters suggested replacing the term "individual's guardian" to "guardian of the estate" to avoid conflict with program standards. The department responds by making the requested modifications. Regarding sec.406.51(c)(6) and (8), two commenters stated that the department previously made assurances it would add clarifying language to the paragraph. The department responds that it is actively seeking clarifying language in the form of federal guidelines. The department, however, was unable to identify the federal guidelines cite before the subchapter was scheduled to be adopted. Federal employees are currently researching the Social Security regulations in an attempt to locate the guidelines necessary for clarification. The rule will be amended when the federal guidelines are identified. Regarding sec.406.57, two commenters suggested adding language clarifying that providers are not expected to seek approval of consultant subcontracts commonly used in the provision of professional services. The department responds by adding clarifying language. Regarding sec.406.61(a), two commenters requested that language indicate contract termination occurs only for cause, i.e., significant contract violations that remain uncorrected. The department responds by deleting language allowing contract termination if it is in the department's best interest. Regarding sec.406.62(g), two commenters questioned if this subsection is consistent with Home and Community-based Services rules on the same issue and with the new level-of-need rules. The department responds by ensuring consistency in affected rules. Regarding sec.406.64(a)(3)(B), two commenters suggested including a reference to materiality and intent to ensure that the rules are not used unfairly. The department responds that if an administrative hearing is requested to appeal the issue, then the administrative law judge will determine materiality and intent. Two commenters identified several references to Chapter 409 which should be Chapter 406. The department responds by correcting the references. The new sections are adopted under the Health and Safety Code, sec.532.015(a), which provides the Texas Mental Health and Mental Retardation Board with broad rulemaking authority; and under the provisions of Texas Government Code, which provides the Texas Health and Human Services Commission with the authority to administer federal medical assistance funds. sec.406.51.Participation Requirements. (a) To participate in the Title XIX Texas Medical Assistance Program and receive state and federal reimbursements for services to eligible individuals, Intermediate Care Facilities for the Mentally Retarded (ICFs/MR) must satisfy the following conditions. (1) The facility must have an approved application on file with the Medicaid Administration section of the Texas Department of Mental Health and Mental Retardation (TDMHMR) or its designated agent to participate as an ICF/MR in the Title XIX Texas Medical Assistance Program, as specified in sec.406.52 of this title (relating to Application for Enrollment (General Provisions)) and sec.406.53 of this title (relating to Provider Application Requirements Specific to ICF/MR). (2) The Texas Department of Human Services (TDHS) must have furnished TDMHMR or its designated agent with a valid certification for the facility. (3) The facility's owner or authorized representative must have a written contract with the department to provide services to eligible individuals. (4) When applicable, the facility must be currently licensed under TDHS minimum licensing standards for facilities serving people with mental retardation or a related condition. (b) Each facility must comply with federal and state standards for participation on an ongoing basis as stated in its contract. To continue participating, facilities must immediately correct deficiencies affecting the health and safety of clients. Failure to correct deficiencies under the contract or under federal or state standards within specified time periods is cause for immediate suspension of vendor payments and may result in contract suspension, cancellation, or other actions including, but not limited to: (1) requesting payment of valid audit exceptions, and (2) requiring contract compliance by a specified date. (c) No participating facility may engage in any of the following restrictive practices: (1) requiring an individual to make a will designating the facility as a legatee or devisee; (2) requiring an individual to assign life insurance to the facility; (3) requiring an individual to transfer property to the facility; (4) requiring an individual to pay a lump-sum entrance fee or make any other payment or concession to the facility beyond TDMHMR or its designated agent's recognized rates for room, board, and care; (5) inappropriately restricting an individual, the guardian of the estate, or any other responsible party in the use of the individual's personal needs allowance; (6) prohibiting an individual from leaving the facility at will except as provided by state law; (7) preventing an individual from applying for Medicaid for a specified period of time; (8) withholding services from an individual solely because the individual has refused to accept a particular dosage of medication or a particular method of administering it; (9) denying appropriate care to an individual because of the individual's race, religion, color, national origin, sex, age, handicap, marital status, or source of payment; and (10)preventing an adult from exercising the right to make decisions concerning the individual's medical care, or to formulate advance directives. (d) Each contracting facility must comply with the Civil Rights Act of 1964, Title VI (Public Law 88-352); the Rehabilitation Act of 1973, sec.504 (Public Law 93-112); the Americans with Disabilities Act of 1990 (Public Law 101-336); and all amendments to these acts and all requirements imposed by the regulations issued under these acts. These acts and regulations prohibit persons in the United States from being excluded from participation in, or denied, any aid, care, service, or other benefits provided by federal and/or state funding, or otherwise being subjected to any discrimination on the basis of race, color, national origin, sex, age, disability, or religion. In addition, each facility must comply with Chapters 81 and 85 of the Texas Health and Safety Code (relating to workplace and confidentiality guidelines regarding human immunodeficiency virus (HIV) and acquired immune deficiency syndrome (AIDS)), and Texas Administrative Code, Title 40, Chapter 73. (e) Each contracting facility must comply with applicable TDMHMR contracting rules in Chapter 401, Subchapter E, of this title (relating to Contracts Management) and Chapter 401, Subchapter D of this title (relating to Contracts Management for Community- Based Services). If there is a conflict between the applicable sections of those subchapters and the provisions of this subchapter, the provisions of this subchapter will prevail. sec.406.53.Provider Application Requirements Specific to ICF/MR. (a) The words and terms in paragraphs (1)-(3) of this subsection, when used in this section, shall have the following meanings, unless the context clearly indicates otherwise: (1) Applicant-The individual(s) and/or entities specified on TDMHMR's or its designated agent facility ownership information form who: (A) operate a for-profit organization, (B) serve as the authorizing entity for a nonprofit organization, or (C) have management or ownership control. (2) Affiliate-An individual or entity associated with either the applicant or the facility so that any one of them directly or indirectly controls or has the power to control one another in whole or in part. (3) Designated representative-The chief executive officer, the chief financial officer, the president or executive director, or other individual who serves in an upper management, decision- making capacity and has financial responsibility for the proposed facility. (b) All applicants for participation in the ICF/MR program must submit an application to the TDMHMR or its designated agent for review and approval. The application must include documentation to verify the applicant's ability to ensure the delivery of quality care and services. (1) The documentation submitted must indicate that the following persons will have completed the ICF/MR preapplication training course prior to approval of the application: (A) the applicant and/or a designated representative, other than a consultant; and/or (B) the individual who will be responsible for the direct management of the facility; or (C) those who, at the time of application, are not owners of an ICF/MR facility in the Texas ICF/MR program. (2) If the employment status of the persons specified in paragraph (1) of this subsection changes prior to approval of the application, approval of the application will be postponed until the appropriate persons complete the training. (c) All applications must meet the requirements specified in paragraphs (1)-(3) of this subsection. (1) Requested certification is limited to a maximum of six beds per facility. This includes new facilities seeking initial certification and currently certified facilities seeking to increase the certified bed capacity. (2) The proposed facility is in compliance with applicable special use permit requirements, local zoning, and/or occupancy code requirements, and sec.406.51 of this title (relating to Participation Requirements). (3) The proposed facility must submit documentation to verify that the mental retardation authority (MRA) in whose catchment area the proposed facility is located has been notified of the development of the proposed facility and the proposed facility's admission criteria. (d) The applicant has 270 calendar days from the date an application for participation in the ICF/MR program has been approved by TDMHMR or its designated agent to obtain certification by TDHS. If, at the end of the 270 calendar day period, the provider is unable to obtain certification, the request for program participation will be withdrawn by TDMHMR or its designated agent and the application will be returned to the applicant. (1) TDMHMR or its designated agent may grant applicants one 90- calendar-day extension for new construction delayed by inclement weather, natural disaster, construction strike, requirements of governmental entities other than the survey agency, or other causes beyond the provider's control. New construction does not include renovations or modifications to existing structures. The request for the extension must: (A) be submitted in writing to TDMHMR or its designated agent prior to the end of the 270 calendar day period, and (B) include documentation to support the circumstance which caused the delay. (2) If there is a delay by the survey agency that is not the fault of the applicant which results in failure to obtain certification within the 270- calendar-day period, TDMHMR will grant an extension an to enable completion of the process. The extension will continue until the date of the scheduled survey. A copy of the notification granting an extension will be forwarded to the provider and other governmental entities as appropriate. (3) Extension periods due to litigation may be granted: (A) until litigation is resolved, plus 270 days if construction was stopped because of a court order, but in no event will the extension period be longer than two years; or (B) for a length of time at TDMHMR's discretion, if: (i) there was no construction; or (ii) construction was not stopped as provided in subparagraph (A) of this paragraph. (4) If an applicant must change locations following application approval by TDMHMR or its designated agent, the change in location must: (A) be requested within the first 30 days from the date of the original application approval and include the relocation information required by TDMHMR or its designated agent; (B) meet all requirements set forth in this section and be approved by TDMHMR Medicaid Administration or its designated agent; (C) remain within the same general geographic region as the previously approved location; and (D) not alter the applicant's ability to obtain certification within the 270- calendar-day period set forth in this subsection. (e) TDMHMR will approve applications that meet all requirements set forth in this section and are within the service capacity set forth in The Plan on Long- Term Care for People with Mental Retardation or Related Conditions. Applications that have not received approval from TDMHMR or its designated agent within a 90- calendar-day period from the date submitted will be withdrawn from the review process and returned to the applicant. (1) TDMHMR or its designated agent reserves the right to deny the approval of any application if the applicant or an affiliate has been excluded from Medicaid program participation under Chapter 409, Subchapter C of this title (relating to Fraud and Abuse and Recovery of Benefits) or debarred from contracting with TDMHMR in accordance with this subchapter. TDMHMR or its designated agent also reserves the right to postpone the approval of any application if the applicant or an affiliate is currently under investigation or review for potential fraud, abuse, or misuse of Medicaid funds or for any violation for which a sanction could be taken under Chapter 409, Subchapter C of this title (relating to Fraud and Abuse and Recovery of Benefits). (2) As necessary, staff from TDMHMR or its designated agent will contact the applicant to facilitate completion of the application process. Upon approval, TDMHMR or its designated agent will notify TDHS that the facility can begin the certification survey process. If a facility's license is revoked, then the: (A) facility's certification will be revoked; and (B) the facility's provider contract will be canceled. (3) The contract for services is dependent on compliance with the provisions of this section. sec.406.57.Subcontracts. (a) Subcontracts are contracts for providing a part or all of the program components. Such contracts are between the party contracting with the department and the subcontractor. (b) Each subcontract, except those for ancillary or support services, such as janitorial services, must contain a provision that the subcontractor agrees to accept and abide by all terms and conditions imposed on subcontractors under the primary contract between the department and the contractor. sec.406.61.Notice of Termination. (a) If TDMHMR intends to terminate a facility provider agreement for contract violations, it will notify the provider. The notice at minimum must include the effective date of the termination and a notice of the contractor's right to appeal the adverse action in accordance with Chapter 409, Subchapter B of this title (relating to Adverse Actions). (b) The department may immediately terminate a contract for cause if not disallowed by law. sec.406.62.Sanction Provisions for Violations of Title XIX ICF/MR Contractual Agreements. (a) The following words and terms, when used in this section, shall have the following meanings, unless the context clearly indicates otherwise. (1) Direct or immediate adverse effect-A situation in which a significant, unfavorable risk or source of danger exists. Direct or immediate adverse effect does not include remote or minimal risk or effect. (2) Immediate jeopardy-A situation in which a facility's noncompliance with one or more standards for participation poses a serious threat to the health and safety of an individual(s) residing in the facility, making immediate corrective action necessary. (3) New admission-The admission of an individual who has never been previously admitted to the facility or who, if previously admitted, was discharged or voluntarily left the facility. New admissions do not include: (A) individuals who lived in the facility before the effective date of denial of payment for new admissions, even if the individuals become eligible for Medicaid after that date; and (B) individuals who, after a temporary absence from the facility for a therapeutic visit or extended therapeutic visit as described in sec.406.211 of this title (relating to Payment for Absences from the Facility), are readmitted to beds reserved for them. (b) TDMHMR takes the following action(s) when a Title XIX contracted facility fails to meet the requirements specified in this chapter, as cited in writing by TDHS, which is the state survey agency. (1) When TDHS notifies TDMHMR in writing that TDHS is terminating the facility's certification because cited deficiencies pose immediate jeopardy to the health and safety of its consumers, TDMHMR: (A) does not offer a compliance period; (B) imposes an immediate vendor hold on state Medicaid payments to the facility; and (C) cancels the facility's contract. TDMHMR normally makes no payment for services provided by the facility after the effective date of TDHS's termination of the facility's certification. However, in certain instances, TDMHMR may continue payments for as many as 30 days after the date that TDMHMR cancels or fails to renew the provider contract. Specifically, TDMHMR may continue payments if TDHS notifies TDMHMR in writing that: (i) the facility is making reasonable efforts to transfer its consumers to another facility or into alternate care, and (ii) additional time is needed to effect an orderly transfer of the facility's consumers. (2) When TDHS recommends a vendor hold on state Medicaid payments to the facility and notifies TDMHMR in writing that cited deficiencies do not pose immediate jeopardy, but do constitute health or safety hazards that have a direct or immediate adverse effect on the facility's consumers' health, safety, security, or training as outlined in their individualized plans of care, TDMHMR takes the following actions. (A) TDMHMR imposes an immediate vendor hold on state Medicaid payments to the facility. (B) If the cited deficiencies are not corrected within 60 days from the date that TDHS finds the facility in noncompliance after an on-site visit, TDMHMR cancels the facility's contract for breach of contract. If the facility appeals an adverse action by TDMHMR and the adverse action is sustained by a contract appeals committee or judicial proceeding, the effective date of the contract cancellation is the date specified in the notice of contract cancellation. Except as otherwise provided in this paragraph, TDMHMR makes no payment for services provided by the facility after the effective date of the facility's contract termination. In certain instances, TDMHMR may continue payments for as many as 30 days after the date that TDMHMR terminates or fails to renew the provider contract. Specifically, TDMHMR may continue payments if TDHS notifies TDMHMR in writing that: (i) the facility is making reasonable efforts to transfer its consumers to another facility or into alternate care, and (ii) additional time is needed to effect an orderly transfer of the facility's consumers. (C) When TDMHMR cancels a facility's contract as specified in this paragraph, the department may enter into a probationary contract with the facility, as specified in sec.406.55(4) of this title (relating to Duration of the Contract). TDMHMR may enter into this contract only after TDHS conducts an on-site, follow- up visit and notifies TDMHMR that: (i) all previously cited deficiencies have been corrected, (ii) no other deficiencies have been found that pose immediate jeopardy to the consumers, and (iii) no other deficiencies have been found that constitute health or safety hazards or that relate to the provision of training as outlined in the consumers' individualized plans of care. (D) After the probationary contract period, TDMHMR may enter into a nonprobationary contract as specified in sec.406.55(1), (2), (3), or (5) of this title (relating to Duration of the Contract). TDMHMR may enter into this contract only after TDHS conducts an on-site, follow-up visit and notifies TDMHMR that: (i) no deficiencies have been found that pose immediate jeopardy to the consumers, and (ii) no deficiencies have been found that constitute health or safety hazards or that relate to the provision of training as outlined in the consumers' individualized plans of care. (3) If a facility is placed on vendor hold three times in any 18-month period for deficiencies in consumer care, as specified in subsection (b)(1) and (2) of this section, TDMHMR takes the following actions. (A) TDMHMR cancels the facility's contract for breach of contract. If the facility appeals an adverse action by TDMHMR and the adverse action is sustained by a contract appeals committee or judicial proceeding, the effective date of the contract cancellation is the date specified in the notice of contract cancellation. Except as otherwise provided in this paragraph, TDMHMR makes no payment for services provided by the facility after the effective date of the facility's contract termination. In certain instances, TDMHMR may continue payments for as many as 30 days after the date that TDMHMR terminates or fails to renew the provider contract. Specifically, TDMHMR may continue payments if TDHS notifies TDMHMR in writing that: (i) the facility is making reasonable efforts to transfer its consumers to another facility or into alternate care, and (ii) additional time is needed to effect an orderly transfer of the consumers. (B) When TDMHMR cancels a facility's contract as specified in this paragraph, the department may enter into a probationary contract with the facility, as specified in sec.406.55(4) of this title (relating to Duration of the Contract). TDMHMR may enter into this contract only after TDHS conducts an on-site, follow- up visit and notifies TDMHMR that: (i) all previously cited deficiencies have been corrected, (ii) no other deficiencies have been found that pose immediate jeopardy to the consumers, and (iii) no other deficiencies have been found that constitute health or safety hazards or that relate to the provision of training as outlined in the consumers' individualized plans of care. (C) After the probationary contract period, TDMHMR may enter into a nonprobationary contract as specified in sec.406.55(1), (2), (3), or (5) of this title (relating to Duration of the Contract). TDMHMR may enter into this contract only after TDHS conducts an on-site, follow-up visit and notifies TDMHMR that: (i) no deficiencies have been found that pose immediate jeopardy to the consumers, and (ii) no deficiencies have been found that constitute health or safety hazards or that relate to the provision of training as outlined in the consumers' individualized plans of care. (c) TDMHMR takes the following action(s) when a Title XIX contracted facility fails to meet applicable agency rules or contractual provisions that are not specified in this chapter, as cited in writing by TDMHMR or TDHS. (1) TDHS citations result in the following actions. (A) At its discretion, TDHS may grant the facility a compliance period of no more than 30 days to correct cited deficiencies. If TDHS finds on a follow-up visit that the cited deficiencies have not been corrected, but the facility has made substantial progress towards correcting them, TDHS may extend the compliance period for a maximum of 15 days. No more than one compliance extension can be granted. (B) If the cited deficiencies are not corrected within the compliance period, TDMHMR imposes a vendor hold on state Medicaid payments to the facility. (C) If the cited deficiencies are not corrected within 60 days after the date the facility is placed on vendor hold, TDMHMR cancels the facility's contract for breach of contract. If the facility appeals an adverse action by TDMHMR and the adverse action is sustained by a contract appeals committee or judicial proceeding, the effective date of the contract cancellation is the date specified in the notice of contract cancellation. Except as otherwise provided in this paragraph, TDMHMR makes no payment for services provided by the facility after the effective date of the facility's contract termination. In certain instances, TDMHMR may continue payments for as many as 30 days from the date that TDMHMR terminates or fails to renew the provider contract. Specifically, TDMHMR may continue payments if TDHS notifies TDMHMR in writing or TDMHMR determines that: (i) the facility is making reasonable efforts to transfer consumers to another facility or into alternate care, and (ii) additional time is needed to effect an orderly transfer of the consumers. (2) TDMHMR administrative citations result in the following actions. (A) At its discretion, TDMHMR may grant the facility a compliance period of no more than 30 days to correct deficiencies cited by TDHS. If TDMHMR determines during the compliance period that the cited deficiencies have not been corrected, but the facility has made substantial progress towards correcting them, TDMHMR may extend the compliance period for a maximum of 15 days. No more than one compliance extension can be granted. (B) If the deficiencies cited by TDHS are not corrected within the compliance period, TDMHMR imposes a vendor hold on state Medicaid payments to the facility. (C) If the cited deficiencies are not corrected within 60 days after the date the facility is placed on vendor hold, TDMHMR cancels the facility's contract for breach of contract. If the facility appeals an adverse action by TDMHMR and the adverse action is sustained by a contract appeals committee or judicial proceeding, the effective date of the contract cancellation is the date specified in the notice of contract cancellation. Except as otherwise provided in this paragraph, TDMHMR makes no payment for services provided by the facility after the effective date of the facility's contract termination. In certain instances, TDMHMR may continue payments for as many as 30 days from the date that TDMHMR terminates or fails to renew the provider contract. Specifically, TDMHMR may continue payments if TDHS notifies TDMHMR in writing or TDMHMR determines that: (i) the facility is making reasonable efforts to transfer consumers to another facility or into alternate care, and (ii) additional time is needed to effect an orderly transfer of the consumers. (d) The facility must not charge Title XIX consumers, their families, guardians, or other responsible parties to recoup vendor payments not received because of the imposition of sanctions against the facility. The facility is entitled to collect only the applied income established in the individual's payment plan. (e) If a facility charges a Title XIX consumer any member of his family, or any other party in order to supplement TDMHMR payments or to secure payment for services that TDMHMR disallows, TDMHMR is entitled to cancel the facility's existing contract or to deny its application to participate in the Title XIX Texas Medical Assistance program, unless the department's policies and regulations explicitly permit the charge(s) in question. (f) A provider may request an administrative hearing in accordance with Chapter 409, Subchapter B of this title (relating to Adverse Actions) if TDMHMR takes or proposes to take the following adverse action: (1) vendor hold; (2) contract termination; (3) recoupment of payments made to the provider; or (4) denial of a provider's request for payment. (g) If the basis of an administrative hearing requested under subsection (a) of this section is a dispute regarding a level-of- need assignment, the provider may receive an administrative hearing only if reconsideration was requested by the provider in accordance with sec.406.214(e) of this title (relating to Reconsideration of Level of Need). sec. 406.63.Debarment and Suspension of Current and Potential Contractor's Rights. (a) Applicability. Requirements in this section are applicable to all types of Medicaid contracts with TDMHMR. These requirements are in addition to, and do not supersede, rules in Chapter 409, Subchapter C of this title (relating to Fraud or Abuse and Recovery of Benefits.) (b) Definitions. The following words and terms when used in sec.sec.406.63- 406.67 of this title relating to (Contracting Requirements) shall have the following meanings, unless the context clearly indicates otherwise: (1) Contractor and subcontractor-Individuals or legal entities who have existing TDMHMR contracts or are otherwise participating providers, including managers of contractors' operations, such as managers and administrators of ICF/MR facilities. (2) Debarment-Termination of rights to continue an existing contract, to receive a new contract, to participate as a provider or manager, or to make a bid, offer, application or proposal for a TDMHMR contract. The debarment is for a specified time commensurate with the seriousness of the violation, the extent of the violation, prior impositions of sanctions or penalties, willingness to comply with program rules and directives, and other pertinent information. The maximum period of debarment is six years, unless a longer time is mandated by requirements other than those in this subchapter. (3) Potential contractor-Individuals or legal entities who wish to submit a bid, offer, application, or proposal for a TDMHMR contract or subcontract, or otherwise request participation as a provider, including managers of contractors' operations, such as managers and administrators of ICF/MR. (4) Suspension of contractual rights-Temporary suspension of a contractor's or potential contractor's right to conduct business with TDMHMR. A suspension is in effect until an investigation, hearing, or trial is concluded and TDMHMR can make a determination about: (A) the contractor's future right to contract or subcontract, or (B) a potential contractor's future right to have TDMHMR consider its offer, bid, proposal, or application. (c) Scope. For purposes of both suspension of contractual rights and debarment, TDMHMR may impute the conduct of an individual, corporation, partnership, or other association to the contractor, potential contractor, or the responsible component or entity of the contractor or potential contractor with whom the individual, corporation, partnership, or other association is employed or otherwise associated. Even though the underlying conduct may have occurred while an individual, corporation, partnership, or other association was not associated with the contractor or potential contractor, suspension of contractual rights or debarment may be imposed. Remedial actions taken by the responsible officials of the contractor or potential contractor will be considered in determining whether either suspension of contractual rights or debarment is warranted. (d) Choice of sanction. Severe violations of the type specified in sec.406.64 of this title (relating to Causes and Conditions for Debarment) may be the basis for suspension of contract rights or debarment even if there is only a single occurrence. However, isolated and less severe violations of TDMHMR contract provisions do not necessarily lead to suspension and/or debarment. Sanctions for isolated and less severe violations may be found in TDMHMR's rules governing the specific program area in which the violations occurred. sec.406.64.Causes for and Conditions of Debarment. (a) Causes for debarment. TDMHMR may remove contractual rights from an individual or legal entity for causes including, but not limited to, the following: (1) being found guilty, pleading guilty, pleading nolo contendere, or receiving a deferred adjudication in a criminal court, relating to: (A) obtaining, attempting to obtain, or performing a public or private contract or subcontract; (B) embezzlement, theft, forgery, bribery, falsification or destruction of records, any form of fraud, receipt of stolen property, or any other offense indicating moral turpitude or a lack of business integrity or honesty; (C) dangerous drugs, controlled substances, or other drug-related offense; (D) federal antitrust statutes arising from the submission of bids or proposals; or (E) any physical or sexual abuse or neglect offense; (2) being debarred from contracting by any unit of the federal government or any unit of a state government; (3) violating TDMHMR contract provisions including failing to perform according to the terms, conditions, and specifications or within the time limit(s) specified in the TDMHMR contract, including, but not limited to, the following: (A) failing to abide by applicable federal and state statutes, such as those regarding persons with disabilities and those regarding civil rights; (B) having a record of failure to perform or of unsatisfactory performance according to the terms of one or more contracts or subcontracts, if that failure or unsatisfactory performance has occurred within five years preceding the determination to debar. Application of this subsection will be made only for actions occurring after the effective date of these rules. Failure to perform and unsatisfactory performance includes, but is not limited to, the following: (i) failing to correct contract performance deficiencies after receiving written notice about them from TDMHMR or its authorized agents; (ii) failing to repay or make and follow through with arrangements satisfactory to the Department to repay identified overpayments or other erroneous payments, or assessed liquidated damages or penalties; (iii) failing to meet standards that are required for licensure or certification, or that are required by state or federal law, TDMHMR rule, or TDMHMR policy concerning TDMHMR contractors; (iv) failing to execute amendments required by TDMHMR; (v) billing for services or merchandise not provided to the consumer or TDMHMR; (vi) submitting cost reports containing costs not associated with and/or not covered by the contract or TDMHMR rules and instructions. Intent to increase individual or statewide rates or fees by submission of unallowable costs must be shown for a single cost report, but intent may be inferred when a pattern of submitting cost reports with unallowable costs is shown; (vii) submitting a false statement or misrepresentation which, if used, may increase individual or statewide rates or fees; (viii) charging consumer or patient fees contrary to TDMHMR rules or policy; (ix) failing to notify and reimburse TDMHMR or its agents for services TDMHMR paid for when the contractor received reimbursement from a liable third party; (x) failing to disclose or make available, upon demand, to TDMHMR or its representatives (including appropriate federal and state agencies) any records the contractor is required to maintain; (xi) failing to provide and maintain services within standards required by statute, regulation, or contract; or (xii) violating the TDMHMR provisions applicable to the contract or any rule or regulation issued by TDMHMR; (4) submitting an offer, bid, proposal or application that contains a false statement or misrepresentation or omits pertinent facts or documents that are material to the procurement; (5) engaging in any abusive or neglectful practice that results in or could result in death or injury to the consumers served by the contractor; or (6) violating any of the provisions outlined in sec.409.055 of this title (relating to Grounds for Fraud Referral and Administrative Sanction). For purposes of this subsection, any reference in Chapter 409, Subchapter C of this title (relating to Fraud and Abuse and Recovery of Benefits), to a violation of the Medicaid (Title XIX), Medicare (Title XVIII), or Title XX programs is expanded to include an identical violation within any programs of federal or state governments; (7) knowingly and willingly using a debarred person or entity as an employee, independent contractor, or agent to perform a contract with TDMHMR. (b) Conditions of debarment. Individuals, parts of entities, and entities that have been debarred may not: (1) receive a contract; (2) be allowed to retain a contract which has been awarded before debarment; (3) bid or otherwise make offers to receive a contract or subcontract; (4) participate in TDMHMR programs which do not require the provider to sign a contract or agreement; or (5) either personally or through a clinic, group, corporation or other association bill to or receive payment from TDMHMR for any services or supplies provided by the debarred entity on or after the effective date of the debarment. Additionally, TDMHMR will not pay for any services ordered, prescribed, or delivered by the debarred entity for TDMHMR recipients after the date of debarment. No costs associated with a debarred entity, including the salary, fringe benefits, overhead, payments to, or any other costs associated with an employee, owner, officer, director, board member, independent contractor, manager, or agent who was debarred may be included in a TDMHMR cost report or any other document which will be used to determine an individual payment rate, a statewide payment rate, or a fee. (c) Entities that may be debarred. Debarment may be applied against an individual, an entire legal entity, or a specified part of a legal entity. sec.406.65.Causes for and Conditions of Suspension. (a) Causes for suspension. TDMHMR may place a contractor or potential contractor's contractual rights in suspension whenever TDMHMR finds that there is a reasonable basis to believe that grounds for debarment as specified in sec.406.64 of this title (relating to Conditions for and Conditions of Debarment) exists. Suspension may be imposed immediately following TDMHMR's notification to a contractor or potential contractor. In addition, suspension may be imposed on a potential contractor or subcontractor if he has an outstanding indictment or the department has information about an offense that is grounds for debarment. (b) Conditions of suspension. (1) TDMHMR may withhold payments, in whole or in part, to the affected contractor during the period of suspension. (2) TDMHMR may refuse to accept a bid, offer, application, or proposal from, or to award a contract to, the affected potential contractor during the period of suspension. (3) TDMHMR may cease referrals of additional consumers to the suspended entity. (4) If TDMHMR determines that the underlying reasons for the suspension have been resolved in favor of the contractor, TDMHMR must, if applicable: (A) pay the withheld payments for any services that may have been provided during the suspension and which meet the terms of an existing contract, and (B) resume contract payments. (5) If TDMHMR determines that underlying reasons for the suspension have not been resolved in favor of the contractor, TDMHMR will institute debarment proceedings. (6) Individuals and entities whose contractual rights have been placed in suspension may not: (A) receive a contract; or (B) submit an offer, bid, application or proposal for a contract. (c) Entities that may be suspended. A suspension may be applied against an individual, an entire legal entity, or a specified part of a legal entity. sec.406.66.Proof Required for Debarment and Suspension. (a) Causes identified in sec.406.64(a)(1) of this title (relating to Causes for and Conditions of Debarment) are established by proof of pleading guilty or nolo contendere, or of the issuance of a deferred adjudication of guilt. If an appeal results in a reversal, contractual rights must be restored upon written request, unless another cause for their removal exists. (b) Causes identified in sec.406.64(a)(2) of this title (relating to Causes for and Conditions of Debarment) are based entirely upon the other state or federal agency's official notice that the contractor or potential contractor's rights have been removed. (c) The existence of all other causes for debarment or suspension must be established by a preponderance of the evidence. sec.406.67.Notice Requirements for Debarment and for Suspension. (a) Contractors' right of notice and appeal. Contractors who have been placed in suspension or who have been debarred or who have been notified of proposed debarment have the appeal rights provided in Chapter 409, Subchapter B of this title (relating to Adverse Actions), governing provider appeal processes for adverse actions. (b) Potential contractors' rights of notice and appeal. Potential contractors who are placed in suspension or who have been debarred have all the notice and appeal rights provided in Chapter 409, Subchapter B of this title (relating to Adverse Actions), governing provider appeal processes for adverse actions. (c) Required content for notices of suspension and debarment. In addition to information required in the notice of adverse actions specified in Chapter 409, Subchapter B of this title (relating to Adverse Actions), notices must include the following, when applicable: (1) the grounds for the action (if an indictment or information is pending or has been returned, the nature of the irregularities is described in general terms without disclosing evidence); (2) the length of the suspension or debarment; (3) a statement explaining the effect of the suspension or debarment; and (4) a statement of whether the suspension or debarment is in effect throughout TDMHMR. 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 March 5, 1997. TRD-9703056 Ann Utley Chairman, Texas MHMR Board Texas Department of Mental Health and Mental Retardation Effective date: March 25, 1997 Proposal publication date: December 24, 1997 For further information, please call: (512) 206-4516 SUBCHAPTER C.Vendor Payments 25 TAC sec.sec.406.101-406.103 The Texas Department of Mental Health and Mental Retardation (TDMHMR) adopts the repeal of existing sec.sec.406.101-406.103 of Chapter 406, Subchapter C, governing Vendor Payments. The repeal accommodates the contemporaneous adoption of new sec.sec.406101-406103 in this issue of the Texas Register. Existing sec.sec.406.101-406.103 are repealed without changes to the text as published in the December 24, 1996, issue of the Texas Register (21 TexReg 12372). The repeal would enable the addition of new sections to Chapter 406, Subchapter C. There was no oral or written testimony regarding the repeal at a public hearing held on January 13, 1997. The repeals are adopted under the Health and Safety Code, sec.532.015(a), which provides the Texas Mental Health and Mental Retardation Board with broad rulemaking authority; and under the provisions of Texas Government Code, sec.531.021, which provides the Texas Health and Human Services Commission with the authority to administer federal medical assistance funds. The repeal affects Texas Human Resources Code, sec.sec.32.001- 322.040, and Texas Government Code, sec.531.021. 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 March 5, 1997. TRD-9703055 Ann Utley Chairman, Texas MHMR Board Texas Department of Mental Health and Mental Retardation Effective date: March 25, 1997 Proposal publication date: December 24, 1997 For further information, please call: (512) 206-4516 The Texas Department of Mental Health and Mental Retardation (TDMHMR) adopts new sec.sec.406.101-406.103 of Chapter 406, Subchapter C, governing Vendor Payments. Existing sec.sec.406.101-406.103 are contemporaneously repealed in this issue of the Texas Register. Sections 406.101-406.103 are adopted with changes to the proposed text as published in the December 24, 1996, issue of the Texas Register (21 TexReg 12373). The adopted new sec.sec.406.101-406.103 revise the formula for the applied income daily reimbursement rate for Title XIX consumers by including the daily rate for an individual's level of need (LON); and revise the special provisions regarding reduced, denied, and incorrect vendor payments and the prohibition of charging or penalizing a Medicaid consumer, a Medicaid consumer's family members, or a Medicaid consumer's representatives for provider claims denied or reduced as the result of the change of an individual's level of need. Language in sec.406.101 is modified to reference the ICF/MR program rather than Title XIX Texas Medical Assistance Program. Language in sec.406.102 is modified to include the process by which ICF/MR consumers may be responsible for paying a portion of the cost of their care, and to delete references to the Texas Department of Human Services. Language in sec.406.103 is modified to correct references. Written comments were received from three respondents regarding adoption of the rule, with several commenters offering recommendations for revision. Those respondents offering comment on the rule include: Private Provider Association of Texas; Develocepts; and, Reimbursement Advisory Panel of TDMHMR. Concerning proposed sec.406.102(c), two commenters state that the language needs to be more clear and flexible. The department responds that it agrees with the comment and has clarified the language. Concerning proposed sec.406.102(e), two commenters stated the language in this section needs to be clarified and should include language referencing materiality and intent to commit fraud as critical to the determination of a violation. The department responds that it is not appropriate to include in this rule all of the elements necessary to prove a violation of the referenced federal statute. The department has changed the rule language to clarify that collection of certain amounts may constitute a violation of the referenced federal statute. The new sections are adopted under the Health and Safety Code, sec.532.015(a), which provides the Texas Mental Health and Mental Retardation Board with broad rulemaking authority; and under the provisions of Texas Government Code, sec.531.021, which provides the Texas Health and Human Services Commission with the authority to administer federal medical assistance funds. The new section affects Texas Human Resources Code, sec.sec.32.001-32.040, and Texas Government Code, sec.531.021. sec.406.101.Vendor Payments. (a) The Texas Department of Mental Health and Mental Retardation (TDMHMR) or its authorized agent makes vendor payments only for periods of time in which all of the following conditions are met: (1) TDMHMR or its designated agent has approved the facility's application to participate in the ICF/MR Program; (2) the state survey agency, the Texas Department of Human Services (TDHS), has licensed, if applicable, and certified the facility for operation; (3) the facility has a signed contract with TDMHMR or its designated agent to provide services to eligible consumers; and (4) the state survey agency has determined that the facility is in compliance with federal regulations and state standards for participation. (b) The state survey agency determines the effective date of eligibility for participation. sec.406.102.Applied Income and the Daily Reimbursement Rate. (a) ICF/MR consumers may be responsible for paying for a portion of the cost of their care, depending on their income. The amount a consumer pays, called "applied income," is established by their Medicaid eligibility worker. The Medicaid eligibility worker then develops a payment plan that the facility uses to determine the amount of applied income to be collected from the consumer. TDMHMR pays providers the portion of the daily reimbursement rate that is not billed as applied income. (b) A Medicaid eligibility worker calculates the daily reimbursement rate paid to the provider by TDMHMR for each ICF/MR consumer by: (1) multiplying the rate established by TDMHMR for the individual's level of need (LON) times the number of days in the month, (2) subtracting the individual's applied income for the month, and (3) dividing the result by the number of days in the month. (c) The facility is entitled to collect from the individual only the monthly amount of applied income specified on the individual's payment plan. (d) When an individual's payment plan requires correction or revision, the facility contacts the Medicaid eligibility worker to request a plan change. The facility may not collect an increased amount of applied income from the individual unless and until the Medicaid eligibility worker changes the payment plan. (e) If an individual does not have a payment plan, the facility contacts the Medicaid eligibility worker to determine how much applied income the individual must pay. If the Medicaid eligibility worker subsequently determines that the individual's correct payment amount is lower than initially specified, the facility must immediately return the amount overpaid and notify the Medicaid eligibility worker of the refund. (f) No facility may collect applied income payments that exceed the payment plan. A violation of this requirement may be a violation of 42 USC Section 1320a-7b, which makes solicitation of supplementation a felony punishable by a fine of up to $25,000 or imprisonment for up to five years or both. Texas Department of Human Services regional staff must report all apparent violations of this requirement. If an investigation verifies an apparent violation, TDMHMR is entitled to recoup or withhold vendor payments, terminate or suspend the contract, take other contract actions, and/or refer the matter to the appropriate legal authority. sec.406.103.Special Provisions Regarding Reduced, Denied, and Incorrect Vendor Payments. (a) If the department or its authorized agent makes vendor payments for services performed during a period in which a facility is not participating in the Title XIX Texas Medical Assistance Program, the facility must refund the payments or the department will recoup the funds. (b) Providers of Title XIX services may not charge or penalize Medicaid consumers, their family members, or their representatives for any claim that the department denies or reduces as a result of a change of LON or the provider's failure to comply with the department rules, regulations, or procedures. (c) Payments may be adjusted by TDMHMR due to the provider's submission of any false statement, misrepresentation, or omission of facts, as indicated in Chapter 409, Subchapter C of this title (relating to Fraud and Abuse and Recovery of Benefits). 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 March 5, 1997. TRD-9703054 Ann Utley Chairman, Texas MHMR Board Texas Department of Mental Health and Mental Retardation Effective date: March 25, 1997 Proposal publication date: December 24, 1997 For further information, please call: (512) 206-4516 SUBCHAPTER D.Reimbursement Methodology 25 TAC sec.sec.406.151-406.152, 406.154-406.160 The Texas Department of Mental Health and Mental Retardation (TDMHMR) adopts the repeal of existing sec.sec.406.151-406.152 and sec.sec.406.154-406.160 of Chapter 406, ICF/MR Programs, Subchapter D, governing reimbursement methodology. The repeal accommodates the contemporaneous adoption of new sec.sec.406.151- 406.152 and sec.sec.406.154-406.158 in this issue of the Texas Register. Existing sec.sec.406.151-406.152 and sec.sec.406.154-406.160 are repealed without changes to the proposed text as published in the December 24, 1996, issue of the Texas Register (21 TexReg 12374). The repeal would enable the adoption of new sections to Chapter 406, Subchapter D. There was no oral or written testimony regarding the repeal at a public hearing held on January 13, 1997. The repeals are adopted under the Health and Safety Code, sec.532.015(a), which provides the Texas Mental Health and Mental Retardation Board with broad rulemaking authority; and under the provisions of Texas Government Code, sec.531.021, which provides the Texas Health and Human Services Commission with the authority to administer federal medical assistance funds. The repeal affects Texas Human Resources Code, sec.sec.32.001- 322.040, and Texas Government Code, sec.531.021. 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 March 5, 1997. TRD-9703053 Ann Utley Chairman, Texas MHMR Board Texas Department of Mental Health and Mental Retardation Effective date: March 25, 1997 Proposal publication date: December 24, 1997 For further information, please call: (512) 206-4516 25 TAC sec.sec.406.151, 406.152, 406.154-406.158 The Texas Department of Mental Health and Mental Retardation (TDMHMR) adopts new sec.sec.406.151-406.152 and sec.sec.406.154-406.158 of Chapter 406, Subchapter D, governing reimbursement methodology, with changes to the proposed text as published in the December 24, 1996, issue of the Texas Register (21 TexReg 12375). Existing sec.sec.406.151-406.152 and sec.sec.406.154- 406.160 are contemporaneously repealed in this issue of the Texas Register. The adopted new sections create a new reimbursement methodology that will target funding to provide more supports for persons with greater needs for staff supervision and intervention. Minor changes were made throughout the subchapter to consolidate information; to provide or correct references; and to correct grammatical usage. Language in sec.406.151 is modified to incorporate definitions of terms used in the subchapter and to identify the two types of facilities: state-operated and non- state operated. Language in sec.406.152 is modified to indicate the time lines for submitting direct services surveys and cost reports; to indicate that requests for extension of due dates must be in writing; and to indicate the department will respond within ten days to a request for an extension. Language was added to sec.406.153(m) clarifying that the records are directly or indirectly related to the provision of contracted services. Clarifying language was added to sec.406.153(n) and (o) regarding exclusions and adjustments of cost reports and notification of such exclusions and adjustments. Language in sec.406.154 is modified to indicate submission time lines for full cost reports and direct cost data. Language in sec.406.155 is modified regarding the conditions under which the actual cost of durable medical equipment is reimbursed and language was deleted regarding the types of services provided. Language in sec.406.156 is modified to identify classes of non-state operated facilities and to outline reimbursement rate determination procedures for non- state operated facilities. Language in sec.406.157 is modified to indicate that fiscal accountability gauges financial performance and to direct service cost survey procedures. Language in sec.406.158 is modified to indicate that the department will seek to obtain a consultant to conduct an independent analysis of cost and operational information for a sample of service providers throughout the state. A public hearing was held on January 13, 1997. No testimony was presented. Written comment was received from Private Provider Association of Texas (PPAT), Austin; Develocepts; Educare; and the Reimbursement Advisory Panel of TDMHMR, Austin. Regarding sec.406.152(e), two commenters suggested language be deleted or modified to address materiality, intent, and opportunity to remedy. The department responds that it is not appropriate to include in this rule all of the elements necessary to establish liability for civil or criminal penalties. The department notes that sec.406.152(j) allows a provider an opportunity to properly complete its cost report. Regarding sec.406.152(f), two commenters suggested the language be modified to allow at least 60 days for quarterly direct cost "surveys" and at least 90 days for full cost reports. The department responds that it believes 45 days is sufficient for direct cost surveys; language has been changed allowing 90 days for full cost reports. Regarding sec.406.152(m), two commenters suggested adding "that are directly or indirectly related to the provision of contracted services" to the end of the second sentence. The department responds by adding the suggested language. Regarding sec.406.152(o), two commenters suggested adding language which required the department to notify a provider of all adjustments to its costs, including any caps. The commenter stated that notifications should not be limited to the desk review and on-site audit processes. The department responds by adding language addressing the commenters' concern. Regarding sec.406.154(b)(1), two commenters suggested adding language exempting those providers that are selected to file a full cost report for the same reporting period. The department responds by adding language addressing the commenters' concern. Regarding 406.154(b)(1), one commenter stated that the department should be careful in its use of the term "facilities" so as to not restrict unnecessarily its ability to collect costs on a provider agency basis. The commenter also stated that if individual cost reports or surveys are required of each separate facility, then the 45-day requirement in sec.406.152(f) is totally unreasonable. The department responds that the commenter's concern is unclear. The department does not believe the use of the term "facility" will restrict its ability to collect cost information from any facility or provider. The 45-day requirement only applies to direct services cost surveys; the time frame for submitting a full cost report is 90 days regardless of the number of facilities. Regarding sec.406.155(d), two commenters suggested modifying the language for clarification regarding the model rate calculation components. The department responds by deleting the subsection. Regarding sec.406.156(b), one commenter expressed dissatisfaction with the way in which facility sizes are defined. Regarding the same section, another commenter expressed concern that the proposed rules would allow ICF/MR providers to manipulate their capacities solely to put their facilities in classes with higher rates, thereby resulting in fewer people receiving ICF/MR services at a higher cost than the current certification configuration would yield. The department responds that the classes of facilities were determined based on data collected by an independent consultant and resulting estimates of the cost of operating various sized facilities. The department further responds that the definitions regarding facility size have been clarified to provide that the size will be determined as of the first day of the full month immediately preceding a rate's effective date in order to avoid the suggested manipulation of certified capacity, to avoid displacement of ICF/MR residents, and to more accurately project program costs during the rate setting process. Regarding sec.406.156(d), two commenters recommended deleted the next to the last sentence in the subsection since the language relates to fiscal accountability and should not be used to rebase rates. The department agrees with the commenters' concerns about this sentence but instead of simply deleting the sentence the department has rewritten the subsection to clarify the fiscal accountability process for this methodology. Regarding sec.406.157(a), two commenters suggested replacing the term "validity" with "financial performance." The department responds by replacing the term. Regarding sec.406.157(b) and (c), two commenters suggested replacing the subsections with language developed by the Reimbursement Advisory Panel in cooperation with department Medicaid staff which more clearly describes fiscal accountability procedures and is consistent with rules governing the Home and Community-based Services Program (HCS). The department degrees and has modified the language as requested. Regarding sec.406.156, one commenter disagreed with the category of facility sizes that placed 14- and 15-bed group homes in the large facility category. The department responds that after outside consultants completed a thorough study of costs associated with facility size, data indicated that costs of 14- and 15-bed facilities should be covered in the new large category. Regarding sec.406.158(a), two commenters suggested deleting the term "at least." The department responds that the intent is to establish the minimum frequency for rebasing the model rates and not to restrict the Texas MHMR Board's ability to manage the program. The new sections are adopted under the Health and Safety Code, sec.532.015(a), which provides the Texas Mental Health and Mental Retardation Board with broad rulemaking authority; and under the provisions of Texas Government Code, Chapter 531 which provides the Texas Health and Human Services Commission with the authority to administer federal medical assistance funds. sec.406.151.Definitions and General Reimbursement Information. (a) The following words and terms, when used in this subchapter, shall have the following meanings, unless the context clearly indicates otherwise: Cost Report-Any cost data or financial information submitted by a provider to TDMHMR. Direct Services Cost Survey-Annual survey conducted by TDMHMR in which cost data related to direct care services is submitted by providers. Full Cost Report-Cost data required by TDMHMR that includes all costs of providing services including direct services costs, administration, facility costs, and all other operating costs relevant to the provision of services. GAAP-Generally accepted accounting principles. GAAS-Generally accepted auditing standards. ICF/MR-An intermediate care facility for persons with mental retardation and related conditions. Person-An individual, partnership, corporation, association, governmental subdivision or agency, or a public or private organization of any character. Provider-Any person with whom TDMHMR has an ICF/MR provider agreement. Provider agreement-Any written agreement that obligates TDMHMR to pay money to a person for goods or services under the Title XIX Medical Assistance Program. Rebase-The revision to the underlying assumptions on which the modeled rates are calculated, including revisions to staffing ratios, pay structure, the composition of direct care staff, or other cost factors used in the formula for modeling the rates. State-operated facility-An ICF/MR for which a facility or division of TDMHMR is the provider. TDMHMR-The Texas Department of Mental Health and Mental Retardation or its designee. (b) TDMHMR reimburses providers for services provided to eligible recipients in ICFs/MR. The Texas MHMR Board determines reimbursement rates at least annually in accordance with Chapter 409, Subchapter A of this title (relating to General Reimbursement Methodology for all Medical Assistance Programs) and this subchapter. There are two types of facilities: non-state operated and state- operated. (1) Non-state operated facilities. (A) Except for demonstration or pilot projects involving experimental classes as specified in sec.406.156 of this title (relating to Rate Setting Methodology), reimbursement rates for levels-of-need are uniform statewide for the same class of non- state operated facilities. Rates are set prospectively with no annual settlement. (B) Classes of non-state operated facilities. Classes of non- state operated facilities are based upon facility size. (2) State-operated facilities. Rates for state-operated facilities are set prospectively based on each facility's historical cost pattern with adjustments for inflation. There is no differentiation based on client level-of-need categories. sec.406.152.Cost Reporting Procedures. (a) Reporting costs. Each provider must submit financial and statistical information on forms provided by TDMHMR on facsimiles which are formatted according to TDMHMR's specifications and are preapproved by TDMHMR. (b) Record keeping requirements. Each provider must retain records according to the requirements in Chapter 406, Subchapter G of this title (relating to Additional Facility Responsibilities). Providers must ensure that records are accurate and sufficiently detailed to support the legal, financial, and statistical information provided to TDMHMR. (c) Noncompliance with record keeping requirements. Failure to retain records that support the information submitted to TDMHMR constitutes an administrative contract violation. In the case of an administrative contract violation, penalties are applied as specified in sec.406.62(c)(2) of this title (relating to Sanction Provisions for Violations of Title XIX ICF/MR Contractual Agreements). (d) Allowable and unallowable costs. Providers must complete cost reports in accordance with sec.406.153 of this title (relating to Allowable and Unallowable Costs) and sec.409.008 of this title (relating to Allowable and Unallowable Costs). (e) Certification. Providers must certify the accuracy of cost reports submitted to TDMHMR. Providers may be liable for civil and/or criminal penalties if the cost report is not completed according to TDMHMR requirements. (f) Due date. Providers must submit direct services cost surveys no later than 45 calendar days after the end of the reporting period or 45 days after the date that TDMHMR mails the form to the provider, whichever is later. Providers must submit full cost reports no later than 90 days after the reporting period or 90 days after the date that TDMHMR mails the form to the provider, whichever is later. (g) Extension of due date. TDMHMR may grant extensions of due dates for good cause. Good cause is defined as one that the provider could not reasonably be expected to control. A provider must submit a written request for extension to TDMHMR before the cost report due date. TDMHMR will respond to a request for extension within 10 working days of its receipt. (h) Cost data. TDMHMR may at times require additional financial and statistical information to ensure the fiscal integrity of the Texas Medicaid ICF/MR Program. Each provider must submit additional information to TDMHMR upon request, unless the information is not at the provider's disposal. (i) Failure to submit requested data. Failure to submit acceptable cost data by the due date constitutes an administrative contract violation. In the case of an administrative contract violation, penalties are applied as specified in sec.406.62(c)(2) of this title (relating to Sanction Provisions for Violations of Title XIX ICF/MR Contractual Agreements). (j) Review of cost data. TDMHMR reviews each provider's cost data to ensure that the financial and statistical information submitted conforms to all applicable rules and instructions. Forms that are not completed according to TDMHMR's instructions or rules may be returned to the provider for proper completion. (k) On-site audits. TDMHMR performs a sufficient number of on-site financial audits to ensure the fiscal integrity of the TDMHMR Medicaid Programs. The number of on-site audits performed may vary. (l) On-site audit standards. TDMHMR performs on-site financial audits in a manner consistent with the generally accepted auditing standards (GAAS) approved by the American Institute of Certified Public Accountants and included in Standards for Audit of Governmental Organizations, Programs, Activities and Functions, issued by the United States Comptroller General. (m) Access to records. Each provider must allow access to any and all records necessary to verify cost data submitted to TDMHMR. This requirement includes records pertaining to related-party transactions and other business activities engaged in by the provider that are directly or indirectly related to the provision of contracted services. Failure to allow inspection of pertinent records within 10 working days following written notice from TDMHMR constitutes an administrative contract violation. In the case of an administrative contract violation, penalties are applied as specified in sec.406.62 (c)(2) of this title (relating to Sanction Provisions for Violations of Title XIX ICF/MR Contractual Agreements). If a central office or other entity pertaining to a multi-facility operation refuses access to records, then the penalties are extended to all of the provider's entities having Medicaid contracts with TDMHMR. Additional rules regarding access to records that are out-of-state are in sec.409.002 of this title (relating to Methods for Cost Determination). (n) Reviews of exclusions or adjustments. A provider who disagrees with TDMHMR's exclusion or adjustment of items in cost reports may request an informal review and, when necessary, an administrative hearing as specified in sec.409.007 of this title (relating to Reviews and Administrative Hearings). (o) Notification of exclusions and adjustments. TDMHMR will notify a provider of exclusions and any adjustments including caps applied to reported costs made during TDMHMR's desk reviews and on-site audits. sec.406.154.Frequency of Reporting Costs. (a) All state-operated provider agencies must annually submit full cost reports as directed by TDMHMR in accordance with Chapter 409, Subchapter A of this title (relating to General Reimbursement Methodology for all Medical Assistance Programs) and sec.406.152 of this title (relating to Cost Reporting Procedures). (b) Non-state operated facilities must submit cost report information as directed by TDMHMR in accordance with Chapter 409, Subchapter A of this title (relating to General Reimbursement Methodology for all Medical Assistance Programs). (1) Except for facilities selected to file a full cost report for the same reporting period, all non-state operated facilities will annually submit direct service cost surveys according to sec.406.152 of this title (relating to Cost Reporting Procedures) and sec.406.157 of this title (relating to Fiscal Accountability). (2) Every three years, a sample of non-state operated facilities will be required to submit full cost reports according to sec.406.152 of this title (relating to Cost Reporting Procedures) and sec.406.158 of this title (relating to Rebasing the Non-State Operated Facility Modeled Rates). sec.406.155.Payments to Non-State Operated Facilities. (a) TDMHMR will pay to non-state-operated facilities modeled rates that will vary by class of facility and a client's level- of-need. (b) The non-state operated facility modeled rates include payment for both residential and day program services. Individuals receive medical and dental services through the Medicaid identification card. Any medical expenses other than covered services are the responsibility of the provider. (c) With a limit of $5,000 per client per year, TDMHMR will pay a provider for the actual cost of a client's durable medical equipment if: (1) the cost of the equipment exceeds $1,000; (2) the facility receives approval from TDMHMR to purchase the equipment; (3) the provider submits a voucher to TDMHMR for the cost of the equipment; and (4) the client is eligible for Medicare benefits and the provider has submitted a Medicare claim and received a response to the claim prior to requesting payment from TDMHMR. (d) There are modeled rates for each level of need for each class of non-state operated facilities. sec.406.156.Rate Setting Methodology. (a) Types of facilities. There are two types of facilities for purposes of rate setting: state-operated and non-state operated. Non-state operated facilities are further divided by classes that are determined by the size of the facility. (b) Classes of non-state operated facilities. There is a separate set of reimbursement rates for each class of non-state operated facilities, which are as follows. (1) Large facility-A facility with a Medicaid certified capacity of 14 or more as of the first day of the full month immediately preceding a rate's effective date or, if certified for the first time after a rate's effective date, as of the date of initial certification. (2) Medium facility-A facility with a Medicaid certified capacity of nine through 13 as of the first day of the full month immediately preceding a rate's effective date or, if certified for the first time after a rate's effective date, as of the date of initial certification. (3) Small facility-A facility with a Medicaid certified capacity of eight or fewer as of the first day of the full month immediately preceding a rate's effective date or, if certified for the first time after a rate's effective date, as of the date of initial certification. (c) State-operated facilities. There are no classes of state-operated facilities. State-operated facilities are reimbursed on a facility-based per diem rate which is determined by each facility's allowable costs, inflated forward to the rate period. The reimbursement rates include residential, day, and comprehensive medical services. (d) Reimbursement rate determination for non-state operated facilities effective January 1, 1997. The Texas MHMR Board determines reimbursement for non-state operated facilities in accordance with Chapter 409, Subchapter A of this title (relating to General Reimbursement Methodology for all Medical Assistance Programs) and this subchapter. (1) The initial modeled rates for calendar year 1997 are set according to paragraph (7) of this subsection. (2) Annual rates for the time period between the years that modeled rates are rebased are set by inflating the previous year's direct cost rates by the IPD- PCE as defined in Chapter 409, Subchapter A of this title (relating to General Reimbursement Methodology for all Medical Assistance Programs). These rates are uniform by class of facility and client level-of-need, and determined prospectively and annually. There is no cost settlement. (3) Every three years, the models from which the rates are based are analyzed to determine if rebasing is necessary. (4) Reimbursement rates combine residential and day program services, i.e., payment for the full 24-hours of daily service. (5) Reimbursement rates are differentiated based on client level- of-need as outlined in Chapter 406, Subchapter E of this title (relating to Eligibility and Review). The levels of need are intermittent, limited, extensive, pervasive, and pervasive plus. (6) Modeled rates are rebased according to sec.406.158 of this title (relating to Rebasing the Non-State Operated Facility Modeled Rates). (7) The modeled rates are based on cost components deemed appropriate for economically and efficiently operated services. The determination of these components is based on a combination of data including, but not limited to, historical costs and operational information collected from a representative sample of ICF/MR providers. Every three years an advisory panel consisting of service providers, advocates, and department personnel, and an independent consultant retained by TDMHMR analyzes available information regarding historical cost and operational data and level-of-need assessment to determine if revisions to the models are necessary. TDMHMR will use the analysis to make recommendations to the Texas MHMR Board regarding rates. (e) Rate determination for state-operated facilities. The Texas MHMR Board determines reimbursement rates for state-operated facilities in accordance with Chapter 409, Subchapter A of this title (relating to General Reimbursement Methodology for all Medical Assistance Programs) and this subchapter. Rates are facility specific, determined prospectively, and cost related. A per diem rate for each facility, which is based on the total projected allowable costs for selected cost centers, is divided by the total days of service the facility delivered either in the rate period or in the cost reporting period. (1) Reimbursement rates for state-operated ICFs/MR are based on the most current costs reported on their cost reports. (2) Costs for each facility are divided into three groups: salaries and benefits, comprehensive medical, and other. These costs are inflated by the factors identified in sec.409.004 of this title (relating to Determination of Inflation Indices). Each facility will have its own per diem rate. (3) Reimbursement rates for newly certified state-operated ICFs/MR facilities are based on a pro forma model. The pro forma rate is the average of all available similarly sized state- operated facilities' per diem rates for that particular rate year. Newly certified facilities will be required to submit three-month cost reports to reflect costs incurred during the first 90 days of certified operation. These costs will be used to determine the facility's specific per diem rate within 180 days of certification. (f) Experimental class. TDMHMR may define experimental classes of service to be used in research and demonstration projects on new reimbursement methods. Demonstration or pilot projects based on experimental classes may be implemented on a statewide basis or may be limited to a specific region of the state or to a selected group of providers. Reimbursement for an experimental class is not implemented, however, unless the Texas MHMR Board and the Health Care Financing Administration (HCFA) approve the experimental methodology. sec.406.157.Fiscal Accountability. (a) General principles. Fiscal accountability is a process used to gauge the ongoing financial performance under the non-state operated facility reimbursement rates. (b) Fiscal accountability will consist of the annual reporting of direct service costs including wages, benefits, staffing, and supervisory span-of-control information from all non-state operated providers. The data will be collected on a cost survey designed by TDMHMR. (c) In 1997, providers are required to submit direct services costs on a survey during a uniform three month period of the year, as selected by the department. The survey will reflect the provider's actual direct costs for the three month period. The direct service costs will be compared to the "direct service cost" component of the modeled rates. In instances where a provider's actual direct service costs, as captured by the quarterly cost surveys, are less than 85% of the direct service revenues in the model, TDMHMR will require additional reporting of costs and other information from the provider. (d) TDMHMR will review the results obtained from the direct services cost surveys submitted for 1997 with representatives of provider associations and advocacy groups to further refine the fiscal accountability process. Direct services cost surveys will be collected for each rate year and in instances where a provider's actual direct service costs are less than 85% of the direct service revenues in the model, TDMHMR may require the provider to: (1) report more detailed financial information; (2) submit to a quality assurance survey and review; (3) submit to a utilization review of all services provided; and/or (4) submit to a detailed audit of all relevant financial records. sec.406.158.Rebasing the Non-State Operated Facility Modeled Rates. At least every three years TDMHMR will assess the viability of the non-state- operated modeled rates using the following process: (1) TDMHMR will seek to obtain a consultant to conduct an independent, detailed analysis of cost and operational information for a sample of ICF/MR service providers throughout the state in accordance with Texas Government Code, Chapter 2254. (2) Site visits will be made to each of the sample providers to collect cost data and discuss operations. (3) An advisory panel consisting of service providers, advocates, and department personnel will analyze available information regarding historical cost and operational data and level-of-need assessment. TDMHMR will use the analysis to make recommendations to the Texas MHMR Board for adjusting the rates or rebasing model-based rates. (4) TDMHMR will recommend adjustments to rate factors if required, based on the results of the analysis of the sample of cost and operational information. (5) Revised rates, as well as the rationale supporting the rates, will be presented to the Texas MHMR Board for final approval and implementation. 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 March 5, 1997. TRD-9703052 Ann Utley Chairman, Texas MHMR Board Texas Department of Mental Health and Mental Retardation Effective date: March 25, 1997 Proposal publication date: December 24, 1997 For further information, please call: (512) 206-4516 SUBCHAPTER G.Additional Facility Responsibilities 25 TAC sec.406.302 The Texas Department of Mental Health and Mental Retardation (TDMHMR) adopts the repeal of existing sec.406.302, of Chapter 406, ICF/MR Programs, Subchapter G, relating to additional facility responsibilities. The repeal accommodates the contemporaneous adoption of new sec.406.302 in this issue of the Texas Register. Existing sec.406.302 is repealed without changes to the text as published in the December 24, 1996, issue of the Texas Register (21 TexReg 12379). The repeal would enable the adoption of a new section to Chapter 406, Subchapter G. There was no oral or written testimony regarding the repeal at a public hearing held on January 13, 1997. The repeal is adopted under the Health and Safety Code, sec.532.015(a), which provides the Texas Mental Health and Mental Retardation Board with broad rulemaking authority; and under the provisions of Texas Government Code, sec.531.021, which provides the Texas Health and Human Services Commission with the authority to administer federal medical assistance funds. The repeal affects Texas Human Resources Code, sec.sec.32.001- 32.040, and Texas Government Code, sec.531.021. 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 March 5, 1997. TRD-9703050 Ann Utley Chairman, Texas MHMR Board Texas Department of Mental Health and Mental Retardation Effective date: March 25, 1997 Proposal publication date: December 24, 1997 For further information, please call: (512) 206-4516 The Texas Department of Mental Health and Mental Retardation (TDMHMR) adopts new sec.406.302 of Chapter 406, Subchapter G, governing Additional Facility Responsibilities. Existing sec.406.302 is contemporaneously repealed in this issue of the Texas Register. Section 406.302 is adopted with changes to the proposed text as published in the December 24, 1996, issue of the Texas Register (21 TexReg 12379). The adopted new sec.406.302 clarifies services reimbursed under day services (e.g., community integration supports and supported employment). The language in sec.406.302 is modified to more fully outline the service components of day services and to enhance grammar and readability. Written comments were received from three respondents regarding adoption of the rule, with several commenters offering recommendations for revision. Those respondents offering comment on the rule include: Private Provider Association of Texas; Reimbursement Advisory Panel of TDMHMR; and, Parents of the Retarded in Texas. Concerning proposed sec.406.302(d)(1), two commenters stated that the phrase "unless contraindicated by the interdisciplinary team (IDT)" should be added to the text, or the entire last sentence should be deleted. The department responds that it agrees with the comment and has deleted the last sentence in 406.302(d)(1). Concerning proposed sec.406.302.(d)(2), one commenter stated that it is not clear whether supported employment is a service that can be billed in addition to day habilitation or whether the two services are mutually exclusive. The department responds that it agrees with the comment regarding the wording and has reorganized the section for reading clarity. There were no changes to the meaning of the text. Supported employment remains a type of day services and there will be no additional funding beyond the day services rate. The new section is adopted under the Health and Safety Code, sec.532.015(a), which provides the Texas Mental Health and Mental Retardation Board with broad rulemaking authority; and under the provisions of Texas Government Code, sec.531.021, which provides the Texas Health and Human Services Commission with the authority to administer federal medical assistance funds. The new section affects Texas Human Resources Code, sec.sec.32.001- 32.040, and Texas Government Code, sec.531.021. sec.406.302.Day Services. (a) In accordance with the requirements of 42 Code of Federal Regulations (CFR) sec.483.410(d)(3) and sec.483.440(a), each facility must ensure that day services furnished by an outside source meet the needs of each client and are integrated with the other components of the client's active treatment program. (b) When an outside source furnishes services to a client, the client's facility must establish and maintain a written agreement with the outside source in accordance with 42 CFR sec.483.410(d)(1)-(3). (c) If subminimum wages are paid to a client, the service provider must maintain the appropriate certification required by the United States Department of Labor. (d) Day services include day habilitation and supported employment. (1) Day habilitation assists individuals in the acquisition, retention, and/or improvement of self-help, socialization, cognitive, and adaptive skills necessary to be successful in the community. Day habilitation provides individuals with opportunities to participate in activities that increase attendance to task, elicit appropriate social and emotional interaction, relieve isolation, and encourage independent utilization of community resources. These opportunities may include enclaves, mobile crews, and other congregate training sites. Day habilitation services include individual assessments, career development, other person-centered services, transportation to and from day services, and attendant care for individuals who are unable to manage their personal care needs away from the residential setting. Whenever possible, public transportation will be utilized. Day habilitation must be designed to provide individuals with opportunities for meaningful activities that enhance their self-esteem, maximize their functioning level, and increase their level of independence. (2) Supported employment is individualized employment in an integrated setting with on-going support services. Employment is work performed by the individual for which the individual is compensated by an employer in accordance with the Fair Labor Standards Act. An integrated setting is a job site away from the individual's place of residence, in which generally no more than one employee or three percent of the employees, whichever is more, have mental retardation or a related condition. Supported employment includes activities that are necessary to sustain paid work by an individual with developmental disabilities. Supported employment is intended to assist individuals in maintaining employment in the community. (A) Reimbursement for supported employment services is available only if documentation verifies that supported employment services have been denied or are otherwise unavailable to the client through either the Texas Rehabilitation Commission or the public school system. (B) All clients receiving supported employment services must have an identified need and desire for employment. 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 March 5, 1997. TRD-9703051 Ann Utley Chairman, Texas MHMR Board Texas Department of Mental Health and Mental Retardation Effective date: March 25, 1997 Proposal publication date: December 24, 1997 For further information, please call: (512) 206-4516 CHAPTER 409.Medicaid Programs SUBCHAPTER A.General Reimbursement Methodology for all Medical Assistance Programs 25 TAC sec.sec.409.1-409.7 The Texas Department of Mental Health and Mental Retardation (TDMHMR) adopts the repeal of existing sec.sec.409.1-409.7 of Chapter 409, Medicaid Programs, Subchapter A, governing reimbursement methodology for all Medicaid assistance programs. New sections would replace existing sec.sec.409.1-409.7 of Chapter 409, Medicaid Programs, Subchapter A, which are adopted contemporaneously in this issue of the Texas Register. Existing sec.sec.409.1-409.7 are repealed without changes as published in the December 24, 1996, issue of the Texas Register (21 TexReg 12380). The repeals would allow for the adoption of new sections governing eligibility and review. There was no oral or written testimony regarding the repeal at a public hearing held on January 13, 1997. The repeals are adopted under the Health and Safety Code, sec.532.015(a), which provides the Texas Mental Health and Mental Retardation Board with broad rulemaking authority; and under the provisions of Texas Government Code, which provides the Texas Health and Human Services Commission with the authority to administer federal medical assistance funds. The repeal affects Texas Human Resources Code, sec.sec.32.001- 32.040, relating to General Provisions, and Texas Government Code, sec.531.021. 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 March 5, 1997. TRD-9703049 Ann Utley Chairman, Texas MHMR Board Texas Department of Mental Health and Mental Retardation Effective date: March 25, 1997 Proposal publication date: December 24, 1997 For further information, please call: (512) 206-4516 25 TAC sec.sec.409.1-409.9 The Texas Department of Mental Health and Mental Retardation (TDMHMR) adopts new sec.sec.409.1-409.9 of Chapter 409, Subchapter A, governing general reimbursement methodology for all medical assistance programs. Existing sec.sec.409.1-409.7 of Chapter 409, Subchapter A, are contemporaneously repealed in this issue of the Texas Register. Sections 409.1-409.5 and sec.sec.409.7- 409.8 are adopted with changes to the proposed text as published in the December 24, 1996, issue of the Texas Register (21 TexReg 12381). Section 409.006 and 409.009 are adopted without changes. The new sections provide a uniform cost reporting process for all Medicaid programs administered by TDMHMR; outline general allowable and unallowable Medicaid costs and reporting practices; and require compliance with federal circular OMB A-87, with additional clarifying information. Language in sec.409.001 was modified to add several definitions. Language in sec.409.2 was modified to identify the sources for cost determination rules. Language in sec.409.3 was modified to incorporate procedures regarding cost of out-of- state audits, which was moved from sec.409.3. Language in sec.409.007 was modified to state informal reviews of exclusions or adjustments will be made by persons not involved in prior reviews of the cost report. Language in sec.sec.409.004- 409.006 and sec.409.008 were modified to correct grammatical usage. A public hearing was convened on January 13, 1997; no testimony was presented. Written comments were received from the Private Provider Association of Texas (PPAT), Austin; Volunteers of America, Arlington; Develocepts, Austin; Educare, Austin; and the Reimbursement Methodology Advisory Panel consisting of representatives of provider agencies, provider associations, advocates, and community mental health and mental retardation centers. Five commenters said they could not support the rules without having an opportunity to review the final versions. The department responds that staff have attempted to provide all interested parties with working drafts of revisions. The response to comments included below reflect an evolving set of rules crafted by numerous interested parties. One commenter expressed concern that massive changes to the computer system would result in disruptions in billing. The department responds that it has attempted to anticipate billing problems and has worked closely with the Texas Department of Human Services (TDHS) to ensure that providers will be paid accurately and on a timely basis. It is anticipated that minor billing edits will occur throughout the spring. Two commenters recommended that generally accepted accounting principles (GAAP) should be referenced in sec.409.001 as the primary standard for determining the cost of services. The department responds that GAAP is used as the accounting methodology used in the rules, and has reorganized the GAAP references to clarify this point. The method of determining the allowability of costs is contained in federal circular OMB A-87. Two commenters requested that sec.409.002(b) should specify that the department will provide adequate notice and reasonable timelines for the completion of requested reports and surveys. The department responds that the proposed rules provide for adequate notice and reasonable deadlines for reports and surveys and has not altered the text as proposed. Two commenters requested that "may" be changed to "will" in the last line of sec.409.002(d). The department agrees with the commenter and has reorganized the section for reading clarity. In subsection (e) of the same section, two commenters requested the addition of language requiring that providers be notified of any exclusions or adjustments made under this section. The department agrees and has revise the language accordingly. In subsection (i) of the same section, two commenters requested that language be included which requires the department to include any data used to determine the payment rates in the rate packet provided to the public prior to a public hearing. The department responds that the material to be provided prior to a public hearing is defined in the state law which requires a public hearing for Medicaid rates. All other data used for rate analysis are available through an open records request and is usually too voluminous to include in a rate packet. In subsection (j) of the same section two commenters requested "cost report based rates" be replaced with "methodology based rates." The department responds that the rule states "may", not "will", so the department does not agree with the comment and has made no changes to the proposed text. Concerning sec.409.003(a), two commenters recommended that "or its designee" be added after the reference to TDMHMR to allow flexibility. The department agrees and has developed new language that provides more specificity regarding the responsibilities of the department. Concerning sec.409.005(c), two commenters requested that on- site audit reports and notices of desk review exclusions and adjustments be mailed to the address provided by the provider on the cost report. The department agrees with the suggestion and modified the language Concerning sec.409.006(a) and (b), two commenters recommended that "may" be change to "shall" and that the sentence referencing a 2.0% threshold be deleted. The department responds that the suggested language would restrict the Texas MHMR Board's decision making ability and would require board action for minor shifts in cost and declines to make the recommended revisions. Concerning sec.409.007(b)(4), two commenters recommended that the membership of the review panel assembled to hear informal reviews should be clearly spelled out and should ensure at least some measure of objectivity by utilizing individuals from outside of the Medicaid Office or from outside of the department. The department concurs with the recommendation and has revised the language accordingly. Concerning sec.409.008(a), two commenters stated that GAAP should provide the primary standard for determining costs and should be mentioned in this section in that context. The commenters further suggested that OMB A-87 should be only a supplementary guide. The department responds that GAAP is used as the accounting methodology used in the rules, and has reorganized the GAAP references to clarify this point. In addition, the department notes that the definitive authority for determining the allowability of costs is federal circular OMB A- 87. In subsection (c) of the same section, two commenters recommended that the last sentence of the first paragraph is unnecessary and confusing. The department concurs and has deleted the sentence. Concerning sec.409.008(c)(3) and (4), two commenters stated that the definitions of direct and indirect costs are inconsistent with those used in the model based rates for ICF/MR and HCS. The department agrees and has clarified the language. In sec.409.008(e)(1), two commenters requested the addition of language describing circumstances under which expenses related to preparation of tax forms and audit/management reports are allowable. The department concurs with the suggestion and has revised the language accordingly. In paragraph (e)(2) of the same subsection, two commenters requested that the second sentence be deleted as unnecessary and inappropriate. The department has clarified the language but declines to delete the language as requested. Still in the same subsection but concerning paragraph (10), two commenters recommended revising the definition of related party and stated that a provider automatically should be limited to the lessor of costs. The department disagrees with the recommendations and declines to revise the language as proposed. The new sections are adopted under the Health and Safety Code, sec.532.015(a), which provides the Texas Mental Health and Mental Retardation Board with broad rulemaking authority; and under the provisions of Texas Government Code, sec.531.021, which provides the Texas Health and Human Services Commission with the authority to administer federal medical assistance funds. sec.409.1.Definitions and General Specifications. (a) The following words and terms, when used in this chapter, shall have the following meanings, unless the context clearly indicates otherwise: Cost Report-any cost data or financial information submitted by a provider to TDMHMR. Direct Services Cost Survey-annual survey conducted by TDMHMR in which cost data related to direct services is submitted by providers. Full Cost Report- cost data required by TDMHMR that includes all costs of providing services including direct care costs, administration, facility costs, and all other operating costs relevant to the provision of services. GAAP-Generally accepted accounting principles. GAAS-Generally accepted auditing standards. Person-An individual, partnership, corporation, association, governmental subdivision or agency, or a public or private organization of any character. Provider-Any person with whom TDMHMR has a provider agreement. Provider agreement-Any written agreement that obligates TDMHMR to pay money to a person for goods or services under the Title XIX Medical Assistance Program. Related Party-Two or more individuals or organizations constitute related parties whenever they are affiliated or associated in a manner that entails some degree of legal control or practical influence of one over the other. TDMHMR-The Texas Department of Mental Health and Mental Retardation or its designee. (b) The Texas Department of Mental Health and Mental Retardation (TDMHMR) reimburses Texas Medicaid contracted providers for medical assistance provided to Medicaid recipients. The Texas Mental Health and Mental Retardation Board determines prospective uniform reimbursement rates at least annually. When program specific rules are in conflict with sections of this subchapter, the program specific rules shall prevail. sec.409.2.Method For Cost Determination. (a) Cost determination rules. Except when otherwise specified under this title, the TDMHMR follows the requirements set forth in the Generally Accepted Accounting Principles (GAAP), the Generally Accepted Auditing Standards (GAAS), and federal circular OMB A-87, Attachment B, and in subsections (b) through (j) of this section as the cost determination rules for providers of services to Medicaid recipients. In cases in which cost reporting rules differ from GAAP, GAAS, IRS, or other authorities, the individual program rules take precedence for provider cost-reporting purposes. (b) Cost reports and cost surveys. Cost reports, when used in this subchapter, will include all types of cost data requested by the TDMHMR including, but not limited to, the Time and Financial Information (TAFI), cost surveys of direct service costs, cost reports, and special cost studies. Cost report due dates will be included with the request for cost data or on the report form. (c) Cost report due dates. (1) Cost Reports. All contracted providers must submit cost reports to the Texas Department of Mental Health and Mental Retardation (TDMHMR) in a manner prescribed by the department. The Department will provide adequate notice and reasonable time lines for the completion of requested reports. The due date of the cost report is included in the cost report instructions. Failure to submit cost reports by the deadline could result in administrative penalties against the provider. (2) Amended Cost Reports. TDMHMR accepts amended cost reports submitted on the request of the provider until 45 days after the due date. Since this is a prospective reimbursement system without a provision for reconciliation, amended cost reports filed after this 45 day extension have no effect on the rate and are not accepted. Amended cost report information that cannot be verified within ten working days of receipt will not be used in rate determination. (d) Exclusions and adjustments. In addition to the exclusions and adjustments made during desk reviews and on-site audits, TDMHMR may exclude or adjust certain expenses in the cost report data base in order to base rates on the reasonable and necessary costs that an economical and efficient provider must incur. These adjustments include, but are not necessarily limited to, revenue offsets, fixed capital asset cost limits, percentile cap limits on administration and facility costs, occupancy adjustments, and cost projections. As specified in sec.409.005 of this title (relating to Notification), providers will be notified about exclusions and adjustments to their reported expenses. (e) Cost inflation. TDMHMR projects expenses in the cost report data base to account for cost inflation between the reporting period and the prospective rate period. The department's procedures for determining inflation indices to account for cost inflation between the reporting period and the prospective rate period are specified in sec.409.004 of this title (relating to Determination of Inflation Indices) (f) Other adjustments. TDMHMR may also adjust rates when new legislation, regulations, or economic factors affect costs, as specified in sec.409.006 of this title (relating to Adjusting Rates When New Legislation, Regulations, or Economic Factors Affect Costs). (g) Projecting cost per unit for programs that are cost-based. After making appropriate exclusions and adjustments, TDMHMR uses the adjusted cost report data to project the cost per unit of service during the prospective rate period. (h) Public hearing. TDMHMR must hold a public hearing before the Texas Mental Health and Mental Retardation Board sets payment rates. The purpose of the hearing is to give interested persons an opportunity to comment on the department's proposed rates. The department must provide notice of the hearing to the public; and at least ten days before the hearing takes place, the department must make material pertinent to the proposed rates available to the public. At a minimum, this material must include the department's proposed rates, the inflation rates used to determine them, and the impact on rates of the major cost limits applied under the provisions of subsection (d) of this section. TDMHMR must furnish this material to anyone who requests it from the TDMHMR division responsible for rate recommendations. After the hearing, TDMHMR must provide the Texas Mental Health and Mental Retardation Board with a written summary of the comments made during the public hearing. (i) Pro forma analysis. If, in the professional opinion of TDMHMR staff, an insufficient number of accurate, full-year cost reports is submitted or there is information that causes doubt about the accuracy or applicability of the available data, the Texas Mental Health and Mental Retardation Board may promulgate payment rates based on a pro forma analysis by TDMHMR. A pro forma analysis is defined as an item-by-item calculation of the essential expenses necessary for an economic and efficient provider to operate. The pro forma analysis must be based on all the information available, including valid cost report data and survey data, in a way that ensures that the resultant rates are sufficient to support an economical and efficient provider. The analysis may involve assumptions about the salary of the administrator, staff salaries, employee benefits and payroll taxes, facility depreciation, mortgage interest, dietary expenses, and other facility and administration expenses. To determine the cost per unit of service, TDMHMR adds all the pro forma expenses and divides the total by the estimated number of units of service that a fully operational provider is likely to provide. When TDMHMR determines that sufficient and reliable cost report data have become available, the Texas Mental Health and Mental Retardation Board may replace pro forma rates with cost report based rates. sec.409.3.Basic Objectives and Criteria for Review of Cost Reports. (a) TDMHMR conducts desk reviews of all provider cost reports to ensure that the financial and statistical information submitted in the cost reports conforms to all applicable rules and instructions. (b) The basic objective of TDMHMR desk reviews is to verify that each provider's cost reports: (1) display financial and statistical information in the format required by TDMHMR, (2) report expenses in conformity with TDMHMR's lists of allowable and unallowable costs, and (3) follow generally accepted accounting principles except as otherwise specified in TDMHMR's lists of allowable and unallowable costs, or as otherwise permitted in the case of governmental entities operating on a cash basis. (c) TDMHMR verifies the information specified in subsection (b) of this section by: (1) comparing each provider's reported costs to: (A) past patterns of expenditures for similar services; (B) the results of previous on-site audits; (C) normal operating cost relationships; and (D) industry average costs; (2) reviewing each provider's reported costs to search for: (A) reported unallowable costs; (B) omitted allowable costs; and (C) overstated or understated allowable costs; (3) checking for completion of required information; (4) checking the format for proper cost classification; (5) checking for mathematical accuracy; and (6) adjusting improperly prepared reports. (d) TDMHMR may conduct on-site audits of cost reports. (e) Cost of out-of-state audits. As specified in sec.409.003(a) of this title (relating to Basic Objectives and Criteria for Desk Review of Cost Reports), TDMHMR conducts desk reviews of all the cost reports that it receives. The department also conducts on- site audits of provider records and cost reports. Although the number of on-site audits performed each year may vary, the department seeks to maximize the number of on-site audited cost reports available for use in its cost projections. Whenever possible, the records necessary to verify information submitted to TDMHMR on Medicaid cost reports, including related party transactions and other business activities engaged in by the provider, must be accessible to TDMHMR audit staff in the state of Texas. When records are not available to TDMHMR audit staff within the state, the provider must pay the actual costs for TDMHMR staff to travel and review the records out of state. If a provider fails to reimburse TDMHMR for these costs within 60 days of the request for payment, TDMHMR will place a hold on the vendor payments until the costs are paid in full. As specified in sec.409.005 of this title (relating to Notification), providers will be notified about exclusions and adjustments to reported expenses made during desk reviews and on- site audits. sec.409.4.Determination of Inflation Indices. (a) Function and types of indices. To account for cost inflation between the reporting period and the prospective rate period as specified in sec.409.002 of this title (relating to Methodology), the Texas Department of Mental Health and Mental Retardation (TDMHMR) uses a general cost inflation index and several item- specific and program-specific inflation indices. (b) General cost inflation index. For all medical assistance programs TDMHMR uses the Implicit Price Deflator-Personal Consumption Expenditures (IPD-PCE) as its general cost inflation index. The IPD-PCE is a nationally recognized measure of inflation published by the Bureau of Economic Analysis of the U.S. Department of Commerce. To project or inflate costs from the reporting period to the prospective rate period, TDMHMR uses the lowest feasible IPD-PCE forecast consistent with the forecasts of nationally recognized sources available to TDMHMR at the time rates are prepared for public dissemination and comment. (c) Item-specific and program-specific inflation indices. When TDMHMR can obtain item-specific or program-specific inflation indices for cost report line items such as wages, facility depreciation, and lease appreciation, the department uses these specific indices in place of the general cost inflation index specified in subsection (b) of this section. The specific indices that the department uses include the following: (1) Wage and benefit inflation rates for state school ICF-MR employees are determined by the Texas Legislature and Department merit policy. (2) The inflation index for facility depreciation and lease appreciation is limited by federal regulations (OBRA 1984, COBRA 1985) that require the use of no more than one-half of the Consumer Price Index For All Urban Consumers (CPI- U) for depreciated ICF-MR facilities that change ownership after July 18, 1984. All leased ICF-MR facilities are inflated by no more than one-half of the CPI-U compounded annual rate of change for the most recent consecutive two year period for which information is available at the time reimbursement rates are determined. Other medical assistance programs use the IPD-PCE inflation index to project facility lease costs. (3) The medical care CPI-U is used as the inflation index for the state school ICFs/MR comprehensive medical cost center. To project costs from the reporting period to the prospective rate period, TDMHMR uses the lower of the two medical care CPI-U forecasts reported by Data Resources Incorporated and Wharton Econometric Forecasting Associates. sec.409.5.Notification. (a) TDMHMR mails notification of the exclusions and adjustments to reported expenses. TDMHMR mails notices of desk review exclusions and adjustments within ten working days after entering them in the cost report data base. The notice consists of a letter to the provider and a one page desk review adjustment sheet that specifies: (1) the line items on the cost report that have been adjusted or excluded; (2) the amount of each adjustment or exclusion; and (3) the principal reason for each adjustment, capitation, or exclusion. (b) TDMHMR also furnishes providers with written reports of the results of on- site audits. TDMHMR mails each on-site audit report within 30 days after the final exit interview with the provider. An exit interview is final when TDMHMR has received, reviewed, and analyzed all documentation from the provider pertinent to the scope of the audit. The on-site audit report consists of a multiple page professional report prepared by TDMHMR to enumerate the results of an on-site audit. Each on-site audit report includes a specification of: (1) cost report line items that have been adjusted or excluded; (2) the amount of each adjustment or exclusion; and (3) the principal reason for each adjustment or exclusion. (c) TDMHMR mails on-site audit reports and notices of desk review exclusions and adjustments to the address provided by the provider on their cost report. (d) A provider may also submit a written request for TDMHMR to provide additional information about exceptions and adjustments to the provider's cost reports, including citations of the laws or regulations that constitute the grounds for the exceptions and adjustments. TDMHMR must respond to such requests in writing within 30 calendar days of receiving the request. sec.409.7.Reviews and Administrative Hearings. (a) General requirements. A provider who disagrees with an exclusion or adjustment made during a desk review or on-site audit of that provider, the determination of an inflation index, or a rate adjustment made in response to new legislation, regulations or economic factors under the provisions of this subchapter (relating to General Reimbursement Methodology for Medical Assistance Programs) must follow the procedures for informal reviews and administrative hearings set forth in this section to appeal the action. (b) Informal review. An informal review is conducted according to the following procedures: (1) If a provider disagrees with an exclusion or adjustment made during a desk review or on-site audit of that provider and the provider wants to appeal the exclusion or adjustment, the provider must submit a written request for an informal review within 30 calendar days of receiving TDMHMR's written notification of the exclusion or adjustment. (2) If a provider disagrees with TDMHMR's determination of an inflation index or with a rate adjustment made in response to legislation, regulations or economic factors, and the provider wants to appeal the inflation index or rate adjustment, the provider must submit a written request for an informal review within 30 calendar days of the setting of rates by the TDMHMR Board. An informal review requested under the provisions of this paragraph may only consider whether the requirements of this chapter were followed in developing the rates. (3) A written request for an informal review must be submitted to TDMHMR Medicaid Administration. (4) On receipt of a timely request for an informal review, TDMHMR will appoint a review panel, to be composed of no less than two persons not involved in prior reviews of the cost report. The panel will arrange a meeting at the earliest possible date convenient to both the provider and the panel members. At the meeting, the provider may present any information it considers pertinent to its position. The review panel will consider information presented by the provider and any information from TDMHMR that the panel deems necessary to reach a decision. Within 30 calendar days from the meeting, the panel will send the provider the panel's written decision. The decision will be sent by certified mail, return receipt requested. (c) Administrative hearings. If a provider disagrees with the decision reached in an informal review and the provider wants to appeal the decision, the provider must request an administrative hearing in accordance with Chapter 409, Subchapter B of this title (relating to Adverse Actions) within 15 days after receiving the review panel's decision. (d) Rate not stayed. An informal review or administrative hearing requested under the provisions of this section will not stay the determination, adoption, or implementation of reimbursement rates by TDMHMR. sec.409.8.Allowable and Unallowable Costs. (a) General principles. Allowable and unallowable costs, both direct and indirect, identify expenses which are reasonable and necessary to provide contracted services and are consistent with federal and state laws and regulations. If a particular type of expense is classified as unallowable, then the classification means only that the expense will not be included in the database for reimbursement determination purposes because the expense is not considered reasonable and/or necessary. The classification does not mean that individual contracted providers may not make the expenditure. The description of allowable and unallowable costs is designed to be a general guide and to clarify certain key expense areas. The primary determinant of allowability is whether or not the cost is consistent with the criteria set forth in GAAP and federal circular OMB A-87, Attachment B. This circular is not comprehensive, and the failure to identify a particular cost does not necessarily mean that the cost is an allowable or unallowable cost. (b) Generally accepted accounting principles. Except as otherwise specified by the cost determination rules of this chapter, cost report instructions, or policy clarifications, cost reports should be prepared consistent with generally accepted accounting principles (GAAP) which are those principles approved by the American Institute of Public Accountants (AICPA). Internal Revenue Service (IRS) laws and regulations do not necessarily apply in the preparation of the cost report. In cases in which cost reporting rules differ from GAAP, IRS, or other authorities, TDMHMR rules take precedence for provider cost reporting purposes. (c) Allowable costs. Allowable costs are expenses, both direct and indirect, that are reasonable and necessary, as defined in paragraphs (1) and (2), of this subsection, and which are required in the normal conduct of operations to provide contracted client services meeting all pertinent state and federal requirements. (1) "Reasonable" refers to the amount expended. The test of reasonableness includes the expectation that the provider seeks to minimize costs and that the amount expended does not exceed what a prudent and cost-conscious buyer pays for a given item or service. (2) "Necessary" refers to the relationship of the cost, direct or indirect, incurred by a provider in the provision of client care. Necessary costs are direct and indirect costs appropriate in developing and maintaining the required standard of operation for providing client care in accordance with the contract, and with state and federal regulations. (3) Direct service costs are those costs which are incurred by a provider which are definitely attributable to the operation of providing contracted client services. Whether or not a cost is considered a direct service cost depends upon the specific rules that define the methodology for each program and the contracted client services covered by the program. (4) Indirect costs are those shared costs which benefit, or contribute to, the operation of providing contracted services, other business components, or the overall entity with which the TDMHMR has contracted. Unless defined otherwise in program methodology rules, indirect costs must be allocated, directly or as a pool of costs, across those business components sharing in the benefits of those costs. (d) Unallowable costs. Unallowable costs are expenses that are not reasonable or necessary to the provision of contracted services. The placement as an allowable cost on a cost report of a cost which has been determined to be unallowable may constitute an administrative contract violation and/or may constitute fraud. (e) Specifications for allowable and unallowable costs. The primary criteria of allowability is whether or not the cost meets the definitions as set forth in the federal circular OMB A-87, Attachment B. Except where specific exceptions are noted, the allowability of all costs is subject to the general principles in subsections (a) and (b) of this section and/or in circular OMB A- 87, Attachment B. The following are exceptions, or elaborations, to circular OMB A-87, Attachment B and subsection (b): (1) Accounting and audit fees. Except for Schedule C or Partnership returns related to a contracted provider, expenses for preparation of personal tax returns, and production and/or distribution of annual reports for stockholders or investors are not allowable. Expenses for the preparation of audit/management reports for use by management staff or board members in directing or managing provider operations are allowable. (2) Legal expenses. Legal retainers are not allowable in and of themselves. Legal costs associated with the provision of client services are allowable. Legal costs associated with litigation between the provider and a governmental entity are unallowable. Legal costs associated with any other unallowable cost are also unallowable. (3) Depreciation and use allowances/equipment and other capital expenditures. Purchases of equipment with an asset value at, or more than, $2,500 and an estimated useful life of more than one year must be depreciated or amortized, using the straight line method. In determining whether to expense or depreciate a purchased item, a contracted provider may expense any single item costing less than $2,500 or having a useful life of one year or less. Depreciation and amortization expenses for unallowable assets and costs are also unallowable, including amounts in excess of those resulting from the straight line method, capitalized lease expenses in excess of actual lease payments, and goodwill or any excess above the actual value of physical assets at the time of purchase. (4) Tax expense and credits. Income taxes (federal, state and local) are not allowable. Taxes in connection with financing, refinancing, or refunding operations, such as taxes on the issuance of bonds, property transfers, issuance or transfer of stocks are unallowable as a tax expense. Expenses based on tax fines or tax penalties, and any associated interest, are not allowable. (5) Grants, gifts, and income from the endowments and operating revenue. (A) Grants and contracts from federal government such as transportation grants, United States Department of Agriculture grants, education grants, Housing and Urban Development grants, and Community Service Block Grants, should be offset, prior to reporting on the cost report, against the particular cost or group of costs for which the grant was intended. (B) Contracts, grants, gifts, and income from endowments from private sources, or state and/or local governments, used to purchase allowable program items should not be offset by the contracted provider prior to reporting on the cost report. All such funds which are properly allocable to the cost report should be reported on a contracted provider's cost report, as well as any allowable costs to which the unrestricted funds were applied. (C) Nonroutine revenues such as income from operations not associated with providing contracted services should be offset or reduced by the related expenses prior to reporting the revenue on the cost report. Expenses related to providing these types of non-contracted operations are unallowable costs. If nonroutine operating expenses, (including overhead costs) generate nonroutine operating revenue, in excess of nonroutine operating revenues, the net nonroutine operating expenses are not allowable costs. (6) Losses resulting from theft or embezzlement. Losses resulting from theft or embezzlement of property or funds of clients held in trust by the contracted provider are not allowable costs. (7) Direct reimbursement. Any expenses directly reimbursable to the contracted provider which are considered outside the reimbursement payment system are not allowable costs. (8) Charity or courtesy allowance. A charity allowance is a reduction in normal charges due to the indigence of the client or resident. A courtesy allowance is a reduction in charges granted as a courtesy to certain individuals, such as physicians and clergy. These allowances themselves are not costs since the costs of the services rendered are already included in the contracted provider's costs. (9) Partial allocation of expenses for items not used entirely in the provision of contracted services. Whenever otherwise allowable expenses for facilities, materials, supplies, or services are attributable partially to personal or other business interests and partially to contracted services, the latter portion may be allowed on a pro rata basis if the proportion used for contracted services is well-documented. (10) Related-party transactions. Allowable costs are those which result from arm's length transactions involving unrelated parties. In related-party transactions, the allowable cost is limited to the cost to the related party, either the actual purchase prices paid by the related party or to the usual and customary charges for comparable goods and services, whichever is less. Two or more individuals or organizations constitute related parties whenever they are affiliated or associated in a manner that entails some degree of legal control or practical influence of one over the other. This can be based on common ownership, past or present mutual interests in any type of enterprise, or family ties. (11) Fines assessed as administrative penalties and costs or interest associated with such penalties are unallowable. (f) Medicaid as payor of last resort. Medicaid is the payor of last resort. Costs for which a recipient had Medicare Part A or B benefits, third-party payor benefits, vendor drug coverage, or any other benefits available are not allowable unless the provider can document that a provider of services was not accessible. At a minimum, the documentation must include a list of the providers contacted, date(s) of contact, person to whom spoken, telephone number, and reason for rejection. 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 March 5, 1997. TRD-9703048 Ann Utley Chairman, Texas MHMR Board Texas Department of Mental Health and Mental Retardation Effective date: March 25, 1997 Proposal publication date: December 24, 1997 For further information, please call: (512) 206-4516 SUBCHAPTER D.Home and Community-based Services 25 TAC sec.sec.409.100, 409.101, 409.103, 409.106, 409.107, 409.118, 409.120 The Texas Department of Mental Health and Mental Retardation (TDMHMR) adopts amendments to sec.409.101 and new sec.sec.409.100, 409.103, 409.106, 409.107, 409.118, and 409.120 of Chapter 409, Subchapter D, relating to home and community-based services (HCS). Existing sec.sec.409.103, 409.106, 409.107, and 409.118 are contemporaneously repealed in this issue of the Texas Register. Sections 409.100-409.101, 409.103, 409.106, 409.107, 409.118, and 409.120 are adopted with changes to the proposed text as published in the December 24, 1996, issue of the Texas Register (21 TexReg 12386). New sec.409.100 specifies the service components provided by the HCS program, with any associated exclusions or limitations, and the service delivery units for each component. The amendments to sec.409.101 revise the current rule language to indicate the specific conditions under which an applicant or participant may request a fair hearing. New sec.409.103 defines a process and criteria for the initial assignment and annual reevaluation of a payment category assignment for a program participant based on a determination of an individual's level of need. This section replaces the current per diem reimbursement methodology with a fee-for-service methodology and defines the general and specific conditions for payment of program provider claims for reimbursement for each HCS service component. New sec.409.106 delineates the specific circumstances under which an HCS program provider may request an administrative hearing from the department. New sec.409.107 revises the cost reporting process and requirement to conform to the proposed reimbursement and rate setting methodology. New sec.409.118 implements a model-based rate setting methodology by which the fee-for-service reimbursement rates are established for each HCS service component. New sec.409.120 provides criteria and processes for departmental review and approval of revisions to level-of-need assignments and of specified individual plans of care. Language in sec.409.100 has been revised from the proposal to include the basis for selecting HCS Program service components, to remove references to billable service units and to include requirements for documenting an individual's need for services. This section was also modified to clarify what respite care is reimbursable under HCS when provided to individuals living in their family homes and to indicate that supported employment is provided in conjunction with day habilitation and may be provided to individuals without a previous history of institutionalization with general revenue funding. Section 409.101(c) was revised to allow greater flexibility in determining program eligibility with regard to maximum estimated service costs. Language in sec.409.103 was revised to clarify the level of need assignment process and to remove inconsistencies in terminology. Section 409.107 was revised to exclude providers submitting full cost reports from requirements to submit a direct service cost survey for the same reporting period, to change the cost reporting period to the state fiscal year, and to remove inconsistencies in terminology. Reporting and record keeping requirements included in this section were revised to parallel the requirements for the intermediate care facilities for the mentally retarded (ICF/MR) program. Section 409.107 was modified to include a section addressing fiscal accountability. Section 409.118 was revised to change the term "model-based rates" to modeled rates, to specify that relevant historical and operation cost information will be used in determining modeled rates and to specify that an independent firm will be included on the reimbursement advisory panel. Other terminology in sec.409.118 was revised to correct inconsistencies with Chapter 409, Subchapter A of this title (relating to General Reimbursement Methodology for all Medical Assistance Programs) and sec.409.107 of this title (relating to Reporting Costs). Section 409.120 was reorganized and revised to delineate the department's authority to conduct utilization and review activities, to specify the responsibilities of the department and of providers in the utilization review process, the conditions for reimbursement approval, and procedures providers must use to request the department to reconsider its decision. A public hearing regarding the proposed rules was held January 13, 1997, at which no comments were received. Written comment was received from the Reimbursement Methodology Advisory Panel consisting of representatives of provider agencies, provider associations, advocates, and community mental health and mental retardation centers; Central Gulf State-Operated Community MHMR Services, Richmond; Educare, Austin; and the Private Providers Association of Texas (PPAT), Austin. Several commenters requested the inclusion of clarifications of specific billing units and billing procedures in the sec.409.100. The department responds that in order to retain the original purpose of the section and avoid misunderstanding of the actual billing process, references to the billable service delivery units in the section have been removed and detailed instructions and explanations are being included in the billing procedures distributed to HCS Program providers. The section will retain the reimbursement limits for supported employment, adaptive aids, minor home modifications, and dental treatment. The billing and reimbursement procedures also will be revised to address the following concerns expressed by commenters: clarification of billing for case management services in the event a consumer transfers between program providers mid-month; and the need for definitions of the allowable full and partial billing units for each service component. One commenter expressed concern that the term "supported home living" in the HCS service array may cause confusion with another service term "supported living" which is used by the department. The department appreciates the commenter's concern and will track and respond to any confusion that may result from the use of the two terms. The HCS waiver request and the provider instructions will contain a specific definition of the services covered under the supported home living service component and the qualifications of eligible service providers. Two commenters suggested that the proposed description of respite care implied that individuals receiving HCS residential support or HCS foster care could not receive respite through a source other than the HCS program. The department has revised sec.409.100(a)(5) to clarify that respite care provided to individuals receiving residential support or HCS foster care is not reimbursable through the HCS program. This service could be included on the portion of the individual plan of care detailing community services provided through other resources. One commenter urged the department to allow up to six program participants to receive respite in the same setting. The capacity of HCS respite settings is outside the purview of this proposed rule and the rule will not be revised to address the capacity of these settings. However, the department is studying this recommendation and, if a decision is made to change the capacity of respite settings, the change will be reflected in a revision to the HCS Consumer Principles for Evidentiary Certification. Two commenters recommended that the department clarify the distinction between the supported home living component and the respite care component as soon as possible. The department agrees this distinction requires clarification and will distribute guidelines to providers in the near future. Two commenters recommended that sec.409.100(a)(6) specify that documentation of a denial of services for day habilitation is not required in order to provide these services through the HCS Program. The department appreciates the commenters' concern but declines to revise the rule as recommended. In most cases, the department does not intend to require documentation of a denial of day habilitation services through another source in order for day habilitation to be initially approved as part of an individual plan of care. The department needs to retain the option to review such documentation and to challenge a provider's billing for day habilitation when the service is provided free of cost to the provider or is clearly available through and the responsibility of another source. Two commenters requested that the department revise sec.409.100(a)(7) to clearly state that supported employment may be provided as a billable service in addition to day habilitation services for an individual. Three commenters additionally recommended that this section clearly include the department's intent to reimburse providers for supported employment provided to individuals who had not been previously institutionalized in an ICF/MR or nursing facility. The department has revised the language to stipulate that supported employment may be provided in conjunction with day habilitation and that supported employment may be provided as a state fund reimbursed, but not Medicaid reimbursed, service to individuals without a history of such institutionalization, contingent on availability of state funding. Two commenters stated that the allowable lifetime maximum expenditure specified in sec.409.100(a)(9) for minor home modifications of $7,500 per individual was too restrictive and did not allow for changes in an individual's choice of residence or extenuating circumstances requiring a change in a living setting. It was recommended that a special review and approval process be available when additional minor home modifications were needed. The department appreciates the commenters' concerns but declines to make adjustments to this maximum expenditure. The department will investigate the alternative processes for review and approval suggested by the commenters. One commenter recommended that the department eliminate the requirement for day habilitation services to be provided six hours per day since it will be possible to bill for this service in partial units. The department responds that although providers were not reimbursed through the HCS program, they historically have been required to assure that six hours of age appropriate day services be available to program participants. Inclusion of day habilitation as a reimbursable service does not change this program standard and, therefore, sec.409.100(6) will not be revised as recommended. A commenter asked for clarification in this subchapter that consumers can pay for services in excess of the yearly or lifetime maximum HCS reimbursement amounts for services. The department responds that while the commenter is correct that consumers may pay for additional services in excess of the allowable maximum, the department does not agree this should be stipulated in this rule. One commenter urged the department to examine the impact of the new fee-for- service reimbursement methodology on continued eligibility of currently enrolled consumers and to consider an alternative to the current criteria limiting the annual cost of services for an individual to a maximum of 125% of the average annualized per capita cost of ICF/MR services. The commenter recommended more flexibility in the criteria while continuing to place limits on the maximum cost of services for an individual. The department agrees and has revised sec.409.101(c) to allow flexibility to approve service plans with an estimated cost exceeding the average ICF/MR cost of services based on the demonstration of an individual's need for more extensive services. The revised section incorporates the program standard requiring services to be necessary to prevent an individual's institutionalization, to supplement rather than replace the individual's natural supports, and to be based on needs identified through assessment of the individual's condition. The revised section limits the cost of HCS program services to a maximum cost equal to 125% of the cost of services delivered in a small ICF/MR facility to an individual having a comparable level of need or equal to 125% of the average annualized per capita cost for ICF/MR services, whichever is greater. In addition, the process and criteria for approving individual service plans exceeding the average annual ICF/MR cost has been included in sec.409.120. Two commenters recommended that, in the future, the department consider including definitions of services and billing units within sec.409.103. The department appreciates the commenters' remarks and will consider their recommendation in future rule revisions. Two commenters requested that sec.409.103(b) be modified to define the terminology "at cost" to include reimbursement for a "nominal administrative fee" as part of the cost for providing adaptive aids, minor home modifications and dental treatment. The department does not agree that an additional administrative charge over and above that in the case management rate should be included in the reimbursement for provision of these services. Two commenters recommended that sec.409.103(c)(1)(B) be revised to allow the department some discretion in reviewing level of need assignments that do not directly correspond to the Inventory for Client and Agency Planning (ICAP) service level scores. The department agrees and has revised this section to indicate that levels of need not directly corresponding to the ICAP service level score are subject to utilization review. Two commenters pointed out an apparent error in sec.409.103 regarding the Form 3650 documentation related to the intervention code designating the staff intervention necessary to classify an individual as having a pervasive plus level of need. The department has corrected the language to state "an intervention code of 2 on at least one of the Items 70-73" and thanks the commenters. Two commenters specified that timelines for billing stated in sec.409.103(g)(4) appeared to be acceptable but asked for clarification on how the timelines were determined and documented. The department has reviewed this section and believes the explanation of timelines to be clear and consistent with the billing instructions for other Medicaid programs operated by the department. A commenter recommended that the department modify language in sec.409.103(g)(3) to provide a mechanism to remedy situations in which payment for services is denied when an individual plan of care has expired but services continued to be provided. The department responds that the existence of a current individual plan of care is an eligibility requirement and the department cannot make a payment for an ineligible individual. A commenter stated that the timelines for billing for service contained in sec.409.103(g)(4) were not acceptable for billing for adaptive aids or minor home modifications due to the process being more cumbersome than for other services. The commenter also requested that the rule be modified to require the department to process claims for adaptive aids and home modifications on a timely basis. The department responds that adaptive aids and home modifications are considered to be provided on the date they are delivered or completed. The department believes that 95 days from the date the aid or modification is provided is an adequate amount of time for a provider to submit the reimbursement request. A commenter recommended that sec.409.103(g)(5) be revised to allow opportunities for providers to retroactively revise individual plans of care to include, and, therefore, allow billing for services which were delivered based on an individual's legitimate need but were not listed on the plan at the time the services were delivered. The department appreciates the commenter's concern but declines to allow this exception until the implications can be studied in light of the new policies concerning approvals of IPC service cost maximums and the new fee-for-service methodology. Two commenters recommended that sec.409.107 parallel the comparable section in ICF/MR program. The department has revised appropriate portions of sec.409.107 to parallel the reporting process for the ICF/MR program. Two commenters recommended the addition of a new subsection to sec.409.107 regarding fiscal accountability. The department agrees with the recommendation and has added sec.409.107(s) to address fiscal accountability. Two commenters recommended that sec.409.118(d) specify that the model rates are based on relevant information. The department revised the subsection as requested. Two commenters recommended that sec.409.118(f) be revised to specify the inclusion of an independent consultant in the development of model rate recommendations. The department has revised this section to specify the inclusion of an independent firm along with service providers, advocates and department personnel in the development of model rate recommendations. Two commenters suggested that proposed language in sec.409.118(g)(1) be revised to be consistent with new language included in sec.409.107 relating to fiscal accountability. The department agrees and has removed language inconsistent with the new language regarding fiscal accountability. Two commenters requested that the reference in sec.409.118(g)(2) to the department's analysis of the model rates "at least every three years" be changed to "every three years." The department declines the revised the language as requested, and explains that the intent of the rule is to establish the minimum frequency for rebasing the model rates and not to restrict the ability of the Texas MHMR Board to manage the program. Two commenters recommended that the process used to adjust the model rates parallel the ICF/MR process for non-stated operated ICF/MRs. The department responds that language in sec.409.118(g)(2) parallels the process used to adjust the model rates for non-state operated ICF/MRs with the exception that the HCS process will be based on a state fiscal year cycle. Two commenters recommended that the requirement for a written request for approval of a plans of care would be unnecessarily burdensome and bureaucratic since the department is able to identify plans which exceed the specified cost threshold. The commenters recommended that provider initiated requests for approval be limited to instances of increases in levels of need. The department revised the proposed section on utilization review to indicate instances requiring utilization review prior to authorization of reimbursement and to clarify provider and departmental responsibilities for completing the process. The revised section incorporates the proposed process for reconsideration of departmental decisions. The new sections and amendments are adopted under the Healthand Safety Code, sec.532.015(a), which provides the Texas Mental Health and Mental Retardation Board with broad rulemaking authority; and under the provisions of Texas Government Code, which provides the Texas Health and Human Services Commission with the authority to administer federal medical assistance funds. sec.409.100.Service Components of Home and Community-based Services (HCS) Program. (a) HCS service components are selected for inclusion in an applicant's or program participant's Individual Plan of Care (IPC) to supplement rather than replace that individual's natural community supports. HCS service components are selected based on assessments which identify specific services and supports necessary for the individual to continue living in the community and prevent the individual's admission to institutional based services. The following service components are available to all individuals enrolled in the HCS Program unless indicated otherwise: (1) Case management is provided to all individuals enrolled in the HCS Program. (2) Counseling and therapies, consisting of physical therapy, occupational therapy, speech and language pathology, audiology, social work, psychology, and dietary services may be provided according to the IPC. (3) Nursing care may be provided in accordance with the IPC by licensed nurses. (4) Residential assistance does not include payments for room and board and may be provided in accordance with the IPC in one of the following three ways: (A) Supported home living is provided to individuals who are living in their own homes or the homes of their natural families; (B) HCS foster care is provided to individuals who are living in the home of a foster family provider or paid companion; or (C) Residential support is provided to individuals who reside in homes in which residential assistance is provided by staff who share the residence or who provide assistance on a scheduled shift basis. (5) Respite care may be provided to individuals who are living in the homes of their natural or adoptive family. Respite care is not an HCS reimbursable service for individuals who are receiving HCS foster care or residential support. Respite care may be provided in the individual's residence or in an approved setting outside of the individual's residence. Reimbursement for over- night respite care provided in a setting other than the individual's residence includes payment for room and board. The maximum annual reimbursement per IPC year (an IPC year is defined by the begin and end dates of an individual's IPC, which encompasses a 12-month period of time)is equal to 30 multiplied by the daily reimbursement rate for respite care. (6) Day habilitation may be provided to all enrolled individuals participating in day habilitation program activities which are exclusive of any other separately funded service including but not limited to, public school educational services, rehabilitative services for persons with mental illness, or programs funded by the Texas Department of Human Services or the Texas Rehabilitation Commission. Day habilitation is normally provided outside the individual's residence six or more hours per day five days per week. (7) Supported employment is provided in conjunction with day habilitation and may be provided up to an annual maximum of $3,000 per individual. Supported employment reimbursement is available only if documentation verifies that supported employment services have been denied or are otherwise unavailable to the individual through either the Texas Rehabilitation Commission or the public school system. Medicaid-reimbursed supported employment may be provided only if the participant has a documented previous history of institutionalization in a nursing facility or an intermediate care facility for persons with mental retardation or a related condition. Supported employment may be provided as a state-funded, non-Medicaid reimbursed HCS service component for individuals without a prior history of institutionalization subject to the availability of state funding. Any person receiving supported employment must have an identified need and desire for employment. (8) Adaptive aids may be provided for each individual up to a maximum of $10,000 per IPC year. The individual's interdisciplinary team must approve the provision of all adaptive aids. Provision of adaptive aids outside the scope of those specified in the HCS waiver as approved by the Health Care Financing Administration (HCFA) must be preapproved by TDMHMR Medicaid Administration. (9) Minor home modifications may be provided to each individual up to a life- time maximum of $7,500, after which $300 per IPC year may be provided for maintenance or additional modifications. Provision of minor home modifications outside the scope of those specified in the HCS waiver as approved by HCFA must be preapproved by TDMHMR Medicaid Administration. (10) Dental services may be provided to each individual according to the IPC up to a maximum of $1,000 per IPC year. Dental services outside those specified in the HCS waiver as approved by HCFA will not be reimbursed. (b) The provider must retain in the individual's record results and recommendations of individualized assessments documenting the current need for each service component included in the IPC. IPCs must be developed and updated in accordance with the Consumer Principles for Evidentiary Certification and with sec.409.101(4) of this title (relating to Client Eligibility Criteria.) sec.409.101.Client Eligibility Criteria. (a)-(b) (No change.) (c) An individual will be determined eligible for HCS Program services if the estimated annual cost of services in the individual's IPC (IPC cost) does not exceed 100% of the estimated annualized per capita cost for ICF/MR services. If an individual's IPC cost exceeds 100% of the estimated annualized per capita cost for ICF/MR services, the individual will be eligible for HCS Program services if TDMHMR approves reimbursement, in accordance with sec.409.120 of this subchapter, and the IPC cost does not exceed 125% of the annual ICF/MR reimbursement rate paid to a small ICF/MR, as defined in sec.406.156 of this title (relating to Rate Setting Methodology) for the individual's level of need as it would be assigned under sec.406.204(b) of this title (relating to Level- of-Care Determination and Level-of-Need Assignment) or 125% of the estimated annualized per capita cost for ICF/MR services, whichever is greater. Services included in the IPC must be based on the individual's condition and environment, must be necessary to prevent institutionalization and must supplement rather than replace the individual's natural supports in the community. (d) (No change) (e) Any individual whose request for eligibility for the HCS Program is denied or is not acted upon with reasonable promptness, or whose HCS Program services have been terminated, suspended or reduced by TDMHMR is entitled to a fair hearing, conducted by TDHS, in accordance with 40 TAC sec.79.1101 et seq, except that a request for a fair hearing must be submitted to the TDMHMR Office of Medicaid Administration and received within 90 days from the date of the notice of denial of eligibility for the HCS Program or notice of termination, suspension, or reduction of HCS Program services. sec.409.103.Payment Category Assignment and Provider Claims Payment. (a) Reimbursement to providers for case management, supported home living, counseling and therapies, nursing, and respite care is based upon the unit reimbursement rate for the specific service component. (b) TDMHMR will reimburse providers the actual cost of minor home modifications, adaptive aids, and dental services in accordance with waiver request as approved by HCFA, the HCS provider contract, the individual's IPC, and provider manual requirements. (c) Reimbursement for HCS foster care, residential supports, and day habilitation is based upon the program participant's payment category assignment and the reimbursement rate for the specific service component provided. (1) The payment category for a program participant is based upon a level-of-need (LON) assignment completed by TDMHMR or its designee as part of the level-of- care determination according to 25 TAC sec.406.203. LON assignments are derived from the service level score obtained from the administration of the Inventory for Client and Agency Planning (ICAP) to the program applicant/participant and from selected items on the Level-of-Care Assessment Form (TDHS Form 3650). (A) An HCS Program applicant or participant is assigned one of the following five levels of need; (i) An intermittent LON (LON 1) is assigned if the ICAP service level score equals 7, 8, or 9; (ii) A limited LON (LON 5) is assigned if the ICAP service level score equals 4,5, or 6; (iii) An extensive LON (LON 6) is assigned if the ICAP service level score equals 2 or 3; (iv) A pervasive LON (LON 8) is assigned if the ICAP service level score equals 1. (v) A "pervasive plus" LON (LON 9) is assigned when the TDHS Form 3650 documents an intervention code of 2 on at least one of Items 70-73. (B) The LON assignment may be modified to take into account extraordinary service needs that result from unusual behavioral challenges. The LON for these individuals combines ICAP service level scores and needs identified on selected items on the TDHS Form 3650. A LON that does not directly correspond to the ICAP service level score will be subject to utilization review by TDMHMR or its designee. (i) Individuals who have very challenging behaviors that require a behavior intervention program that includes constant preventive actions by additional provider staff will be assigned the next higher LON from the original level. Additional staff may assist in the supervision of other individuals. Individuals originally assigned a pervasive LON will retain that assignment. Very challenging behaviors have the following characteristics: (I) The behavior presents a danger to the individual or to others; (II) The behavior warrants individualized objectives which include written intervention procedures; (III) The frequency of the behavior is reduced only with constant staffing and a highly structured environment; (IV) The behavior is difficult or impossible for a single staff person to control when it occurs; (V) The behavior precludes some activities and an environment that cannot be structured. The interventions used to control the behavior require regular documentation, monitoring, and revisions as needed to meet the needs of the individual; and (VI) TDHS Form 3650 indicates an intervention code of 1 on at least one of Items 70-73. (ii) Individuals who have extremely challenging behaviors which pose a risk of harm to themselves or others and who require constant one-to-one staff supervision, 16 hours per day, will be assigned a pervasive plus LON. Extremely challenging behaviors have the following characteristics: (I) The behavior may be life-threatening; (II) The behavior warrants the highest priority of individualized objectives which include a written record of every occurrence of the behavior; (III) The frequency of the behavior is difficult to reduce; (IV) The consequences of the behavior are difficult to minimize; and (V) TDHS Form 3650 indicates an intervention code of 2 on at least one of the Items 70-73. (2) The provider completes the ICAP, enters the resulting service level score on the TDHS Form 3650, and completes the remainder of Form 3650. Information entered on the Form 3650 must represent the applicant's/participant's current status. Completed Form 3650 is submitted to TDHS for initial program enrollment or to TDMHMR for annual eligibility reevaluation. (3) TDMHMR reviews LON assignments and, if made in accordance with criteria in this subsection, approves the LON assignment. (A) If TDMHMR determines that information submitted for a LON was not correct or if information previously submitted has changed, the LON assignment is reevaluated and may be changed by TDMHMR. If the LON assignment is changed, reimbursement paid to providers will be adjusted back to the date of the original LON assignment in order to reflect the appropriate LON assignment. (B) The provider in disagreement with an individual's changed LON assignment may request reconsideration by TDMHMR or its designee. Providers must submit written requests for reconsideration of a changed LON assignment in accordance with sec.409.120 to TDMHMR or its designee within ten calendar days of notification of a changed LON assignment. (4) TDMHMR performs annual reevaluations of LON assignments in conjunction with annual reevaluations of ICF-MR LOC. (A) If a higher LON assignment is requested at the time of the annual eligibility reevaluation, the provider must submit supporting documentation to TDMHMR describing the changes in the individual's needs in accordance with sec.409.120 relating to Utilization Review. (B) A provider in disagreement with TDMHMR's denial to increase an individual's LON assignment may request reconsideration by TDMHMR. The provider must submit written requests for reconsideration of the denial in accordance with sec.409.120 to TDMHMR or its designee within ten calendar days of notification of the denial. (5) Providers requesting a change to a higher LON at times other than the annual reevaluation must submit TDHS Form 3650 with supporting documentation describing the changes in the individual's needs to TDMHMR in accordance with sec.409.120, relating to Utilization Review. A provider in disagreement with TDMHMR's denial to increase an individual's LON assignment may request reconsideration by TDMHMR or its designee. The provider must submit written requests for reconsideration of the denial in accordance with sec.409.120 to TDMHMR within ten calendar days of notification of the denial. (d) Units of service must be provided and documented according to the individual plan of care. (e) The provider must submit reimbursement requests in accordance with TDMHMR procedures and accept TDMHMR's payment as payment in full for waiver services. (f) Room and board are not included in the reimbursement rate to providers except in the case of overnight respite care provided in a residence other than the participant's own home or family home. (g) The provider is not entitled to payment if: (1) the client is ineligible for the HCS program, Medicaid benefits, or is an inpatient of a hospital, nursing facility, or ICF-MR; (2) TDMHMR has not authorized client enrollment on the Approval of Application for Enrollment form; (3) services were delivered during gaps in the coverage period for the IPC for HCS form. Coverage periods are defined by the begin and end dates on the IPC for HCS form; (4) the initial claim for service is not received by TDMHMR within 95 calendar days from the end of the month of service or within 30 days of notification of approval of enrollment by TDMHMR, whichever is later; (5) the provider bills for services not included in the IPC during the time the services were provided; (6) the service billed was not provided; (7) the client is discharged from the HCS program. Payment is not made for the day of discharge from the HCS program. sec.409.106.Provider's Right to Administrative Hearing. (a) A provider may request an administrative hearing in accordance with 25 TAC, Chapter 409, Subchapter B of this title, relating to Adverse Actions, if TDMHMR takes or proposes to take the following action: (1) vendor hold; (2) contract termination; (3) recoupment of payments made to the provider; or (4) denial of a provider's request for payment. (b) If the basis of an administrative hearing requested under subsection (a) is a dispute regarding a level-of-need assignment, the provider may receive an administrative hearing only if reconsideration was requested by the provider in accordance with sec.409.103, of this title (relating to Payment Category Assignment and Provider Claims Payment). sec.409.107.Reporting Costs. (a) On an annual basis, all state-operated providers must submit cost reports as directed by TDMHMR or its designee in accordance with Chapter 409, Subchapter A of this title (relating to General Reimbursement Methodology for all Medicaid Assistance Programs). (b) Non-state operated providers must report direct service costs as specified in this subsection and in accordance with Chapter 409, Subchapter A of this title (relating to General Reimbursement Methodology for all Medicaid Assistance Programs). (1) On an annual basis, non-state operated providers will submit direct service cost data except for providers selected to file a full cost report for the same reporting period. (2) Providers must report the following costs: (A) Staff wages related to the delivery of direct services including residential assistance, and day habilitation services; and the direct supervision of the delivery of these services. (B) These costs may be either the provider's actual expense or contracted expenditures. (c) At least every three state fiscal years beginning September 1, 1997, TDMHMR will select a sample of non-state operated providers which will be required to submit a full and accurate account of all costs related to the provision of services for a provider's fiscal year. (d) TDMHMR will conduct desk audits of all cost reports and/or direct service cost surveys, and will conduct on-site reviews of a sample of providers submitting cost reports and/or cost surveys. (e) Record keeping requirements. Each provider must retain records according to the department's requirements. Providers must ensure that records are accurate and sufficiently detailed to support the legal, financial, and statistical information provided to TDMHMR. (f) Noncompliance with record keeping requirements. Failure to maintain records that support the information submitted to TDMHMR constitutes a violation of the HCS provider contract. (g) Allowable and unallowable costs. Providers must complete cost reports in accordance with sec.409, Subchapter A of this title (relating to General Reimbursement Methodology for all Medical Assistance Programs). (h) Certification. Providers must certify the accuracy of cost reports submitted to TDMHMR. Providers may be liable for civil and/or criminal penalties if the cost report is not completed according to TDMHMR requirements. (i) Due date. Providers must submit direct service cost surveys no later than 45 calendar days after the end of the reporting period or 45 days after the date that TDMHMR mails the form to the provider, whichever is later. Providers must submit full cost reports no later than 90 days after the reporting period or 90 days after the date that TDMHMR mails the form to the provider, whichever is later. (j) Extension of due date. TDMHMR may grant extensions of due dates for good cause. Good cause is defined as one that the provider could not reasonably be expected to control. A provider must submit a request for extension in writing to TDMHMR before the cost survey/cost report due date. TDMHMR will respond to a request for extension within ten working days of its receipt. (k) Cost data. TDMHMR may at times require additional financial and statistical information to ensure the fiscal integrity of the HCS Program. Each provider must submit additional information to TDMHMR upon request, unless the information is not at the provider's disposal. (l) Failure to submit requested data. Failure to submit acceptable cost data by the due date constitutes a violation of the HCS provider contract. (m) Review of cost data. TDMHMR or its designee reviews each provider's cost data to ensure that the financial and statistical information submitted conforms to all applicable rules and instructions. Forms that are not completed according to TDMHMR's instructions or rules may be returned to the provider for proper completion. (n) On-site audits. TDMHMR or its designee performs a sufficient number of on- site financial audits to ensure the fiscal integrity of the HCS Programs. The number of on-site audits performed may vary. (o) On-site audit standards. TDMHMR or its designee performs on-site financial audits in a manner consistent with the generally accepted auditing standards (GAAS) approved by the American Institute of Certified Public Accountants and included in Standards for Audit of Governmental Organizations, Programs, Activities and Functions, issued by the United States Comptroller General. (p) Access to records. Each provider must allow access to TDMHMR or its designee to any and all records necessary to verify cost data submitted to TDMHMR or its designee. This requirement includes records pertaining to related-party transactions and other business activities engaged in by the provider that are directly or indirectly related to the provision of contracted services. Failure to allow inspection of pertinent records within ten working days following written notice from TDMHMR constitutes a violation of the HCS provider contract. If the administrative office or other entity pertaining to a multi-contract operation refuses access to records, then the penalties are extended to all of the provider's entities having Medicaid contracts with TDMHMR. Additional rules regarding access to records that are out-of-state may be found in Chapter 409, Subchapter A, sec.409.002 (relating to Methods for Cost Determination). (q) Reviews of exclusions or adjustments. A provider who disagrees with TDMHMR's exclusion or adjustment of items in cost reports may request an informal review and, when appropriate, an administrative hearing as specified in sec.409.007 of this title (relating to Reviews and Administrative Hearings). (r) Notification of exclusions and adjustments. TDMHMR will notify a provider of exclusions and any adjustments, including caps applied, to reported costs in accordance with sec.409.005 of this title (relating to Notification). (s) Fiscal Accountability. (1) General principles. Fiscal accountability is a process used to gauge the ongoing financial performance under the non-state operated reimbursement rates. (2) Fiscal accountability will consist of the annual reporting of direct service costs including wages, benefits, staffing, and supervisory span-of-control information from all non-state operated providers. The data will be collected on a cost survey designed by TDMHMR. (3) In the initial rate period, providers are required to submit direct services costs on a survey during a uniform three month period of the year, as selected by the department. The survey will reflect the provider's actual direct costs for the three month period. The direct service costs will be compared to the "direct service cost" component of the modeled rates. Instances where a provider's actual direct service costs, as captured by the quarterly cost surveys, are less than 85% of the direct service revenues in the model, will require additional reporting of costs and other information from the provider. (4) TDMHMR will review the results obtained from the direct services cost surveys submitted for 1997 with representatives of provider associations and advocacy groups to further refine the fiscal accountability process. Direct services cost surveys will be collected in each fiscal year and instances where a provider's actual direct service costs are less than 85% of the direct service revenues in the model, TDMHMR may require the provider to: (A) Report more detailed financial information; (B) Submit to a quality assurance survey and review; (C) Submit to a utilization review of all services provided, and/or; (D) Submit to a detailed audit of all relevant financial records. sec.409.118.Reimbursement Methodology for Home and Community-Based Services (HCS). (a) TDMHMR determines reimbursement rates according to Chapter 409, Subchapter A of this title (relating to General Reimbursement Methodology for all Medicaid Assistance Programs). (b) Reimbursement rates apply to all non-state operated providers uniformly by type of service component provided and the individual's level-of-need. Reimbursements for state-operated providers are adjusted based on allowed costs reported at the end of the state fiscal year, in accordance with Chapter 409, Subchapter A of this title (relating to General Reimbursement Methodology for all Medicaid Assistance Programs). The state- operated cost adjustment will not exceed allowable federal maximums. (c) Rates are adopted annually by the board and are prospective in nature. (d) Modeled rates are based on relevant cost information including a sample of historical cost information and operational experience of service providers in Texas. The modeled rates are reasonable and adequate to meet the costs that must be incurred by efficiently and economically operated providers to provide services in conformity with applicable state and federal laws, regulations, and quality and safety standards. (e) Rates for service components may also take into account the individual's level of need as defined in sec.409.103 of this title (relating to payment category assignment and provider claims payment). Rates vary by level of need for residential support, HCS foster care, and day habilitation. (f) The modeled rates effective January 1, 1997, are based on cost components deemed appropriate for a provider. The determination of these components is based on historical cost and operational information collected from a representative sample of providers. An advisory panel consisting of service providers, advocates, an independent firm and department personnel, will analyze available information regarding historical cost and operational data and level- of-need assessment. The analysis will result in recommendations to the board for rates which are reasonable and adequate. (g) The rates are derived for each type of service and, when appropriate, each level-of-need and include the following cost factors: direct service staffing costs (wages for direct care, direct care supervisors, benefits, modeled staffing ratios); non- personnel operating costs; facility costs (for respite care only); room and board costs for overnight, out-of-home respite care; administrative costs; and professional consultation and program support costs. (1) Annual rates for the time period between the years that modeled rates are rebased are set by inflating the direct cost portion of the previous year's rates by the IPD-PCE as defined in Chapter 409, Subchapter A of this title, (relating to General Reimbursement Methodology for All Medical Assistance Programs.) TDMHMR will collect the direct costs on a survey during a three month period of the current rate year. The data will reflect the provider's actual costs for the fiscal quarter ending during the three-month period. The direct service costs will be compared to the direct service cost component of the modeled rates. (2) Beginning September 1997, the modeled rates will be analyzed at least every three state fiscal years to determine if rebasing is necessary, using the following process: (A) TDMHMR will seek to retain an independent firm in accordance with Texas Government Code, Chapter 2254, to perform a detailed analysis of cost and operational information for a sample of providers throughout the state. (B) Site visits will be made to each of the sample providers to collect cost data and discuss operations. (C) An advisory panel will be formed consisting of service providers, advocates, and department personnel who will analyze available information regarding historical cost and operational data and level-of-need assessment. TDMHMR will use the analysis to make recommendations to the board for rates which are deemed appropriate. (D) The advisory panel, TDMHMR, and the independent firm will recommend adjustments to rate factors if required, based on the results of the analysis of the sample of cost and operational information. (E) Revised rates, as well as the rationale supporting the rates, will be presented to the TDMHMR Board for final approval and implementation. (3) Refinement/adjustment of the cost factors and model assumptions will be considered, as appropriate, by the TDMHMR Board based on the overall industry results and recommendations of department staff. sec.409.120.Utilization Review. (a) TDMHMR or its designee may conduct a utilization review prior to authorization for HCS reimbursement in any circumstance including but not limited to the following: (1) The provider submits an initial, revised or renewal IPC having an annual cost exceeding 100% of the estimated annualized average per capita cost for ICF/MR services; (2) The provider reports an increase in an individual's LON either at the time of the annual eligibility reevaluation or at any other time; (3) The HCS provider reports the consumer's LON is 9 (Pervasive Plus); and/or; (4) The provider reports a LON for the consumer which appears inconsistent with other clinical or service provision evidence/history about the consumer. (b) TDMHMR or its designee will not approve reimbursement in the circumstances included in subsection (a)(1)-(3) of this section until the provider has submitted documentation supporting the level of service delivery included in the IPC, an increase in a previous LON assignment or the assignment of an LON 9. Providers should send this documentation to TDMHMR, Medicaid Administration, at the same time as the electronic submission of the IPC or the TDHS Form 3650. (1) In order for reimbursement to be approved, providers must submit documentation to TDMHMR which demonstrates the following, as appropriate: (A) that the IPC services proposed for the individual are derived from assessments of the individual's needs, are necessary to prevent the individual from being institutionalized, and support rather than replace the individual's natural community supports and; (B) that the proposed initial or revised LON assignment reflects the individual's current service level need which is expected to continue for at least 12 months. (2) Information submitted by providers must include the Individual Service Plan containing the interdisciplinary team deliberations and conclusions and, as applicable, documentation of assessments or interventions by qualified psychologists or other professional staff/consultants, staff requirements to conduct behavioral intervention plans, medical and physical assessment results and recommendations; time sheets of assigned service providers, and any other documentation providing support of the LON assignment or the level of IPC services. (3) Within ten working days of receiving the supporting documentation, TDMHMR or its designee will notify the provider in writing of the approval or disapproval of the requested LON or the level of service delivery. TDMHMR will establish the effective date of approved requests. (A) If additional documentation is requested by TDMHMR, the provider must respond to the request within five working days of receipt of the request. (B) Within five working days of receipt of the additional information, TDMHMR will inform the provider in writing of the approval or disapproval of the requested LON or the level of service delivery. (c) The provider may request a reconsideration of TDMHMR's decision by submitting a written request to TDMHMR, Medicaid Administration within ten days of the date of notification of the department's decision. The request will be considered and the provider will be notified in writing of the results of TDMHMR's reconsideration within ten working days of receipt of the request. (d) Providers in disagreement with a reconsideration decision related to a LON assignment may request an administrative hearing in accordance with sec.409.106 of this title (relating to Provider's Right to Administrative Hearing). (e) TDMHMR Medicaid Utilization Review Department, or its designee, will conduct periodic retrospective reviews. Based on such reviews, TDMHMR may recoup or deny payment to a provider. This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority. Issued in Austin, Texas, on March 5, 1997. TRD-9703046 Ann Utley Chairman, Texas MHMR Board Texas Department of Mental Health and Mental Retardation Effective date: March 25, 1997 Proposal publication date: December 24, 1997 For further information, please call: (512) 206-4516 25 TAC sec.sec.409.103, 409.106, 409.107, 409.118 The Texas Department of Mental Health and Mental Retardation (TDMHMR) adopts the repeal of existing sec.sec.409.103, 409.106, 409.107, and 409.118 of Chapter 409, Subchapter D, relating to home and community-base services. The repeal accommodates the contemporaneous adoption of new sec.sec.409.103, 409.106, 409.107, and 409.118 in this issue of the Texas Register. Existing sec.sec.409.103, 409.106, 409.107, and 409.118 are repealed without changes as published in the December 24, 1996, issue of the Texas Register (21 TexReg 12390). The repeals would enable the adoption of new sections to Chapter 409, Subchapter D. There was no oral or written testimony regarding the repeal at a public hearing held on January 13, 1997. The repeals are adopted under the Health and Safety Code, sec.532.015(a), which provides the Texas Mental Health and Mental Retardation Board with broad rulemaking authority; and under the provisions of Texas Government Code, which provides the Texas Health and Human Services Commission with the authority to administer federal medical assistance funds. The repeal affects Texas Human Resources Code, sec.sec.32.001- 32.040, relating to General Provisions, and Texas Government Code, sec.531.021. 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 March 5, 1997. TRD-9703047 Ann Utley Chairman, Texas MHMR Board Texas Department of Mental Health and Mental Retardation Effective date: March 25, 1997 Proposal publication date: December 24, 1997 For further information, please call: (512) 206-4516 TITLE 40. SOCIAL SERVICES AND ASSISTANCE PART VI. Texas Commission for the Deaf and Hard of Hearing CHAPTER 181. General Rules of Practice and Procedures SUBCHAPTER F. Fees 40 TAC sec.181.830 The Texas Commission for the Deaf and Hard of Hearing adopts an amendment to sec.181.830, concerning Recommended Fees Schedule for the Payment of Certified Interpreters for the Deaf and Hard of Hearing without changes to the proposed text as published in the September 24, 1996, issue of the Texas Register (21 TexReg 9155). This amendment will clarify the issues of minimum assignment time, portal to portal calculation, and cancellation of assignment pay. No comments were received regarding adoption of the amendment. This amendment is adopted under the Human Resources Code, sec.81.006(b) (3), which provides the Texas Commission for the Deaf and Hard of Hearing with the authority to adopt rules for administration and programs. 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 February 21, 1997. TRD-9702530 David W. Myers Executive Director Texas Commission for the Deaf and Hard of Hearing Effective date: March 13, 1997 Proposal publication date: September 24, 1996 For further information, please call: (512) 451-8494