Proposed Rules Title 25

TITLE 25. HEALTH SERVICES

PART 1. DEPARTMENT OF STATE HEALTH SERVICES

CHAPTER 49. ORAL HEALTH IMPROVEMENT SERVICES PROGRAM

The Executive Commissioner of the Health and Human Services Commission (HHSC) on behalf of the Department of State Health Services (department) proposes the repeal of §§49.1 - 49.15, and 49.17, and new Subchapters A - D, §§49.1 - 49.18, concerning the dental program authorized under the Oral Health Improvement Act, Health and Safety Code, Chapter 43.

BACKGROUND AND PURPOSE

The Oral Health Improvement Services Program (program) rules are used to administer the State Oral Health Program. When fully funded, the program can provide comprehensive oral health services to eligible individuals. Currently, only the dental surveillance, data collection and reporting, and preventive services are funded. The treatment services, which include emergency and restorative services but not orthodontic services, and oral health promotion and education, currently are not funded.

The purpose of the program is to provide comprehensive oral health services to eligible individuals. Based on available funding and priority, oral health services may include dental surveillance, data collection and reporting; provision of preventive oral health services; provision of emergency oral health services; provision of comprehensive oral health services; and oral health promotion and education. Through currently available funding derived from state general revenue and federal grant dollars, central office staff and five regional dental teams consisting of a dentist and dental hygienist conduct dental surveillance, data collection and reporting, and provide preventive oral health services. These services are offered to eligible individuals, which are primarily pre-school and school-age children on the free and reduced lunch program in rural areas of the state who have limited or no access to preventive dental services. Historically, the funds were allocated for the provision of preventive, emergency and comprehensive dental services as well as oral health promotion and education.

Government Code, §2001.039, requires that each state agency review and consider for re-adoption each rule adopted by that agency pursuant to the Government Code, Chapter 2001 (Administrative Procedure Act). Sections 49.1 - 49.15 and 49.17 have been reviewed, and the department has determined that reasons for adopting the sections continue to exist, because rules on this subject are needed. Although the treatment, health promotion, and education portions of the program are not currently funded, retaining the rules allows the oral health treatment program to be implemented quickly if adequate funding is made available.

SECTION-BY-SECTION SUMMARY

Subchapter A. General Provisions. Section 49.1 describes the purpose and application of the rules. Section 49.2 sets forth the definitions used in the rules. Section 49.3 addresses the issue of program priorities and the fact that the provision of services is dependent upon funding. Section 49.4 indicates the methods the department may use to deliver services.

Subchapter B. Recipient Participation. Section 49.5 describes the application process for an individual to be prior authorized for oral health treatment services. Section 49.6 sets forth financial and residency requirements related to eligibility. Section 49.7 addresses the final eligibility determinant to receive oral health treatment services, which involves a dental examination. Section 49.8 addresses the criteria and process for denial, modification, suspension, and termination of oral health treatment services. Section 49.9 addresses a recipient's financial obligations and the potential for recovery of costs by the department.

Subchapter C. Provider Participation. Section 49.10 describes the criteria and requirements for providers to participate in the program. Section 49.11 describes the provider application and contracting process. Section 49.12 addresses the criteria and process for termination of a provider contract. Section 49.13 addresses the payment of a non-provider for emergency care. Section 49.14 describes process and requirements for payment of provider claims. Section 49.15 describes when administrative sanctions may be imposed against a provider.

Subchapter D. Appeals Process. Section 49.16 addresses the administrative review process for an applicant, recipient, or provider to appeal certain program actions and decisions. Section 49.17 sets forth the basis for the right to request a due process hearing by an applicant, recipient, or provider. Section 49.18 describes the due process hearing.

FISCAL NOTE

Ms. Jann Melton-Kissel, the Director of Specialized Health Services Section, has determined that for each year of the first five-year period that the sections are in effect, there will be no fiscal implications to state or local governments as a result of enforcing and administering the sections as proposed.

SMALL AND MICRO-BUSINESS IMPACT ANALYSIS

Ms. Melton-Kissel also has determined that there will be no effect on small businesses or micro-businesses required to comply with the sections as proposed. Interpretation of the rules determined that small businesses and micro-businesses will not be required to alter their business practices in order to comply with the sections. There are no anticipated economic costs to persons who are required to comply with the sections as proposed. There is no anticipated negative impact on local employment.

PUBLIC BENEFIT

Ms. Jann Melton-Kissel, also has determined that for each year of the first five years the sections are in effect, the public will benefit from adoption of the sections. The anticipated public benefit is a clearly worded and succinct set of rules that will facilitate understanding by providers and recipients about benefits, services, rights and responsibilities associated with the Oral Health Improvement Services Program.

REGULATORY ANALYSIS

The department has determined that this proposal is not a "major environmental rule" as defined by Government Code, §2001.0225. "Major environmental rule" is defined to mean a rule the specific intent of which is to protect the environment or reduce the risk to human health from environmental exposure and that may adversely affect, in a material way, the economy, a sector of the economy, productivity, competition, jobs, the environment or the public health and safety of a state or a sector of the state. This proposal is not specially intended to protect the environment or reduce risks to human health from environmental exposure.

TAKINGS IMPACT ASSESSMENT

The department has determined that the proposal does not restrict or limit an owner's right to his or her property that would otherwise exist in the absence of government action and, therefore, does not constitute a taking under Texas Government Code, §2007.043.

PUBLIC COMMENT

Comments on the proposal may be submitted to Dr. Linda M. Altenhoff, DDS, Department of State Health Services, P.O. Box 149347, MC-1938, Austin, Texas 78714-9347, (512) 458-7111, extension 3001, or by email to Linda.Altenhoff@dshs.state.tx.us. Comments will be accepted for 30 days following publication of the proposal in the Texas Register.

LEGAL CERTIFICATION

The Department of State Health Services General Counsel, Lisa Hernandez, certifies that the proposed rules have been reviewed by legal counsel and found to be within the state agencies' authority to adopt.

25 TAC §§49.1 - 49.15, 49.17

(Editor's note: The text of the following sections proposed for repeal will not be published. The sections may be examined in the offices of the Department of State Health Services or in the Texas Register office, Room 245, James Earl Rudder Building, 1019 Brazos Street, Austin.)

STATUTORY AUTHORITY

The proposed repeals are authorized by the Health and Safety Code, Chapter 43, which authorizes the department to provide comprehensive oral health services to eligible individuals; and Government Code, §531.0055, and Health and Safety Code, §1001.075, which authorize the Executive Commissioner of the Health and Human Services Commission to adopt rules and policies necessary for the operation and provision of health and human services by the department and for the administration of Health and Safety Code, Chapter 1001. The review of the rules implements Government Code, §2001.039.

The proposed repeals affect Health and Safety Code, Chapters 43 and 1001; and Government Code, Chapter 531.

§49.1.Purpose.

§49.2.Definitions.

§49.3.Program Priorities.

§49.4.Application Process.

§49.5.Eligibility Requirements.

§49.6.Denial, Modification, Suspension, and Termination of Services.

§49.7.Procedures for Providing Services.

§49.8.Providers.

§49.9.Emergency Selection of Providers.

§49.10.Payment for Services.

§49.11.Coordination of Benefits and Recovery of Costs.

§49.12.Appeals.

§49.13.Confidentiality.

§49.14.Gifts and Donations.

§49.15.Nondiscrimination.

§49.17.Income Guidelines.

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

Filed with the Office of the Secretary of State on June 2, 2008.

TRD-200802830

Lisa Hernandez

General Counsel

Department of State Health Services

Earliest possible date of adoption: July 13, 2008

For further information, please call: (512) 458-7111 x6972

SUBCHAPTER A. GENERAL PROVISIONS

25 TAC §§49.1 - 49.4

STATUTORY AUTHORITY

The proposed new sections are authorized by the Health and Safety Code, Chapter 43, which authorizes the department to provide comprehensive oral health services to eligible individuals; and Government Code, §531.0055, and Health and Safety Code, §1001.075, which authorize the Executive Commissioner of the Health and Human Services Commission to adopt rules and policies necessary for the operation and provision of health and human services by the department and for the administration of Health and Safety Code, Chapter 1001. The review of the rules implements Government Code, §2001.039.

The proposed new sections affect Health and Safety Code, Chapters 43 and 1001; and Government Code, Chapter 531.

§49.1.Purpose and Application.

(a) The rules in this chapter implement the Texas Oral Health Improvement Act, Health and Safety Code, Chapter 43 (Act). The Act authorizes the Department of State Health Services (department) to furnish oral health services to eligible individuals. Oral health services may include oral health promotion and education, preventive oral health services, and oral health treatment services to eligible low-income individuals.

(b) Subchapters B - D of this chapter apply only to the delivery of oral health treatment services under the department's Fee-for-Service Dental Care Program.

§49.2.Definitions.

The following words and terms, where used in these sections, shall have the following meanings, unless the context clearly indicates otherwise.

(1) Act--The Texas Oral Health Improvement Act, Health and Safety Code, Chapter 43.

(2) Action--Denial, modification, suspension or termination of treatment services or participation rights of an applicant or a recipient of the program.

(3) Administrative review--A secondary level of review available to applicants, recipients, and providers who want to resolve a conflict or appeal an administrative sanction or a denied claim.

(4) Administrative sanctions--Penalties imposed on a provider who fails to comply with program rules, policies, procedures or standards, which may include recoupment or adjustment of payments, or payment hold.

(5) Applicant--A person applying to receive oral health treatment services under the program, but for whom eligibility has not been established.

(6) Business day--Normal department operating hours from 8:00 a.m. - 5:00 p.m. Monday through Friday with the exception of state and federal holidays.

(7) Commissioner--The Commissioner of the Department of State Health Services.

(8) Conflict--The proposed modification, suspension or termination of a contract with a provider.

(9) Dentist--An individual licensed by the Texas State Board of Dental Examiners to practice dentistry in the State of Texas.

(10) Dentally accepted standards--Operating in accordance with the laws relating to the practice of dentistry and the rules of the Texas State Board of Dental Examiners and standards of practice.

(11) Department--Department of State Health Services.

(12) Eligible individual--An individual who meets the criteria necessary to receive oral health treatment services under the Act and the rules in this chapter.

(13) Emergency care--Oral health treatment services for relief of pain and infection, including extractions and basic restorative services to prevent premature loss of teeth.

(14) Manual--A compilation of policies, procedures, and instructions prepared by the department's Oral Health Program for the Fee-for-Service Dental Care Program to be used by providers of oral health treatment services. Participating providers will receive a copy of the Manual and any updates, changes, and amendments and must comply with its requirements during participation in the program.

(15) Non-provider--A dentist or physician licensed to practice under Texas state law but not currently under contract with the department to participate in the program.

(16) Oral Health Program (OHP)--The Oral Health Program of the department comprised of central office staff and regional dental teams.

(17) Oral health services--Preventive or treatment services affecting the structures of the mouth, including the hard and soft tissues such as teeth, jaws, gums, vestibule, tongue, checks, lips, floor and roof of the mouth, and adjacent masticatory structure, and oral health education and promotion activities.

(18) Other benefit--A benefit to which an individual is entitled, other than a benefit provided under the Act, for the payment of costs of oral health treatment services, including benefits available from:

(A) an insurance policy, group oral health plan, or prepaid oral care plan;

(B) Title XVIII or Title XIX of the Social Security Act, as amended (42 U.S.C. §1395 et seq. and 42 U.S.C. §1396 et seq.);

(D) the Civilian Health and Medical Program of the Uniformed Services;

(E) worker's compensation or any other compulsory employer's insurance program;

(F) a public program created by federal law, state law, or the ordinances or rules of a municipality or political subdivision of the state; or

(G) a cause of action for dental or oral health treatment services expenses or a settlement or judgment based upon the cause of action, if the expenses are related to the need for treatment services provided under the Act.

(19) Physician--An individual licensed by the Texas Medical Board to practice medicine in the State of Texas.

(20) Program--The department's Fee-for-Service Dental Care Program administered by the department's OHP, which provides oral health treatment services to eligible individuals.

(21) Provider--A person with whom the department contracts to provide oral health treatment services under the Act.

(22) Recipient--A person approved as eligible to receive oral health treatment services.

(23) State dental director--A Texas licensed dentist who serves as the manager of the OHP, or that person's designee.

(24) State fiscal year--The period from September 1 through August 31 of the following year.

(25) Support--The contribution of money or services necessary for a person's maintenance, including food, clothing, shelter, transportation, and health care.

(26) Third-party nominator--A person aware of an applicant's economic condition who refers the applicant to the program for services. Third-party nominators include school administrators, school nurses, social workers, city or county officials, public health clinics, community health centers, dentists, physicians, or hospitals or any other source acceptable to the Executive Commissioner of the Health and Human Services Commission.

§49.3.Program Priorities.

(a) The provision of any and all oral health services is subject to the availability of funds.

(b) The department determines at the beginning of each biennium the categories of persons that will have priority for oral health services under the program, based upon the funding that is available. The department may change program priorities at any time.

(c) Providers must comply with all policies, procedures, and requirements for participation, including program priorities, and the program Manual.

(1) The department adopts by reference the program Manual, including all related policies, procedures, and any updates, changes, and amendments.

(2) A copy of the Manual is given to each provider participating in the program and is available for public inspection during regular business hours at the department's headquarters at Department of State Health Services, Texas Health Steps Branch, Mail Code 1938, 1100 West 49th Street, Austin, Texas 78756.

(d) Based upon the availability of funds, program services may be made available in every health service region of the state. The department determines the amount of funds to allocate to a health service region, and may modify the allocation at any time. Program administration is carried out through the department's central office and health service regions.

§49.4.Methods of Delivering Services.

Delivery of oral health services may be accomplished by any of the following methods.

(1) The department may provide or contract for oral health services, which may be limited to preventive services or oral health education and promotion activities.

(2) The department may contract with providers to participate in the program and provide oral health treatment services for eligible individuals. Requirements for provider participation and reimbursement are set forth in the program guidelines, instructions, and fee schedules in the Manual and related program policies and procedures.

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

Filed with the Office of the Secretary of State on June 2, 2008.

TRD-200802831

Lisa Hernandez

General Counsel

Department of State Health Services

Earliest possible date of adoption: July 13, 2008

For further information, please call: (512) 458-7111 x6972

SUBCHAPTER B. RECIPIENT PARTICIPATION

25 TAC §§49.5 - 49.9

STATUTORY AUTHORITY

The proposed new sections affect Health and Safety Code, Chapters 43 and 1001; and Government Code, Chapter 531.

§49.5.Application Process.

(a) An applicant for oral health treatment services must be referred to the program by a third-party nominator who knows the individual's economic condition.

(b) Each applicant for oral health treatment services must complete or cause to be completed an application form, which shall include the following information for the individual needing services:

(1) personal information, including name, address, birthdate, gender and ethnicity;

(2) a statement from the referring third-party nominator that the oral health treatment services are necessary to prevent or reduce the probability of pain, infection, or disease; and

(3) a statement by the applicant or the person responsible for the applicant's support that:

(A) services are requested;

(B) the applicant is a bona fide resident of Texas and the family income does not exceed the financial guidelines as required in §49.6 of this title (relating to Eligibility Requirements for Referral);

(D) the applicant or the person responsible for the applicant's support is financially unable to pay for all or part of the cost of the necessary oral health treatment services.

(c) Each applicant who will be referred for oral health treatment services, as described in §49.7 of this title (relating to Eligibility Requirements to Receive Oral Health Treatment Services), must have his/her application prior authorized in accordance with program policies and procedures, as defined in the Manual and any updates, changes, and amendments.

(d) The denial of any application must be in writing and must include the reason(s) for such denial. Unless the application is denied because program funds are reduced, curtailed, or unavailable, the individual applying for oral health treatment services has the right to an administrative review and a due process hearing in accordance with Subchapter D of this chapter (relating to Appeals Process).

(e) An individual has the right to reapply for program coverage at any time when there is a change of situation or condition.

§49.6.Eligibility Requirements for Referral.

(a) In order for a person to be eligible for referral for oral health treatment services, the applicant must meet the following criteria:

(1) the person must be a bona fide resident of Texas, which is a person who:

(A) is physically present within the geographic boundaries of the state;

(B) has an intent to remain within the state;

(D) does not claim residency in any other state or country; or

(2) the person is:

(A) residing in Texas and his/her parent(s), conservator, guardian, or caretaker, with whom the person consistently resides, is a bona fide resident of Texas; or

(B) residing in Texas and is the legal dependent spouse of a bona fide resident.

(b) The person must establish a financial need for oral health treatment services, which is based on family income, in accordance with program policies, procedures, and the Manual.

(1) The family income used to determine eligibility is the gross annual income of the applicant and his/her spouse, if applicable, or the gross annual income of person(s) legally obligated to support the applicant;

(2) Gross annual income includes earned wages, pensions or retirement benefits, child support payments received, alimony, unemployment compensation, worker's compensation, income from rental properties, or any monies received on a regular basis for family support purposes; and

(3) Income guidelines are based on current United States Department of Agriculture (USDA) poverty guidelines for determining eligibility for free meals (e.g. school free lunch program guidelines), which are incorporated by reference.

§49.7.Eligibility Requirements to Receive Oral Health Treatment Services.

(a) Following prior authorization of an application in accordance with §49.5 of this title (relating to Application Process), an applicant will be referred for a dental examination to determine whether the applicant is eligible to receive oral health treatment services. With the exception described in §49.13 of this title (relating to Treatment Services by Non-providers), a prior authorized applicant will be referred to a provider for this examination.

(1) The examining provider must certify to the department that he/she has examined the applicant and that the applicant is eligible to receive oral health treatment services in accordance with program policies and procedures, program priorities, and the Manual.

(A) If the applicant meets the eligibility requirements to receive oral health treatment services, the provider will perform the services in accordance with program policies, procedures, and the Manual.

(B) If the applicant does not meet the eligibility requirements to receive oral health treatment services, the provider will be paid only for the examination services provided, in accordance with program policies, procedures, and the Manual.

(2) Notwithstanding the provisions of paragraph (1) of this subsection, the final determination concerning an applicant's eligibility to receive oral health treatment services is made by the state dental director, in accordance with program policies, procedures, and the Manual.

(b) The applicant's initial eligibility date shall be the date upon which the application was prior authorized, as described in §49.5 of this title and will be effective for the remainder of the state fiscal year. Eligibility must be re-established for any subsequent state fiscal year in which oral health treatment services are sought, in accordance with the policies, procedures, and program priorities in effect at that time. To maintain eligibility for oral health treatment services throughout a state fiscal year, the individual must continue to meet the eligibility requirements set forth in §49.6 of this title (relating to Eligibility Requirements for Referral).

§49.8.Denial, Modification, Suspension, and Termination of Oral Health Treatment Services.

(a) Any person requesting or receiving oral health treatment services from the program may be notified that such services may be denied, modified, suspended, or terminated if:

(1) information in the application is erroneous or falsified;

(2) the person is not eligible;

(3) required personal information is not provided;

(4) obligated reimbursement to the program is not provided;

(5) program funds are reduced or curtailed; or

(6) program priorities are modified.

(b) The program will notify in writing the applicant or recipient or the person legally obligated to support the applicant or recipient of the action proposed to be taken and the reasons for such proposed action. The applicant or recipient shall have the right to an administrative review and/or a due process hearing in accordance with Subchapter D of this chapter (relating to Appeals Process) unless the action resulted from the reduction or cessation of program funds.

§49.9.Financial Obligations and Recovery of Costs.

(a) An individual is not eligible to receive oral health treatment services furnished by the Act to the extent that the individual or any person who has the legal obligation to support the individual is eligible for some other benefit that would pay for all or part of the services.

(b) An individual who applies for or receives oral health treatment services furnished under the Act must inform the department at the time of application and at any time during a period of eligibility to receive oral health treatment services of any other benefit to which the individual or any person who has the legal obligation to support the individual may be entitled.

(c) An individual who has received oral health treatment services covered by some other benefit, or any person who has a legal obligation to support that individual, must reimburse the department to the extent of the oral health treatment services furnished when the other benefit is received.

(d) The eligibility requirement in subsection (a) of this section may be waived by the commissioner in certain individually considered cases where its enforcement will deny oral health treatment services to a class of otherwise eligible individuals because of conflicting state, local, or federal laws or regulations.

(e) The department may recover the cost of oral health treatment services provided under the Act from:

(1) a person who does not pay or reimburse the department as required by the Act and the rules in this chapter; or

(2) from any third party who has a legal obligation to pay other benefits and to whom notice of the obligation has been given.

(f) At the request of the commissioner, the attorney general may bring suit in the appropriate court of Travis County, Texas, on behalf of the department. The court may award attorney's fees, court costs, and interest accruing from the date on which the department provides the service to the date the department is reimbursed pursuant to a judgment in favor of the department.

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

Filed with the Office of the Secretary of State on June 2, 2008.

TRD-200802832

Lisa Hernandez

General Counsel

Department of State Health Services

Earliest possible date of adoption: July 13, 2008

For further information, please call: (512) 458-7111 x6972

SUBCHAPTER C. PROVIDER PARTICIPATION

25 TAC §§49.10 - 49.15

STATUTORY AUTHORITY

The proposed new sections affect Health and Safety Code, Chapters 43 and 1001; and Government Code, Chapter 531.

§49.10.Provider Participation Requirements.

Providers must meet the following criteria in order to participate in the program:

(1) agree to comply with all program policies, procedures, rules and requirements, and the Manual;

(2) agree to accept program fees as payment in full;

(3) treat all applicants and recipients without discrimination;

(4) ensure that program recipients or persons legally responsible to support program recipients are not billed for the difference between the provider's regular fees and those paid by the program; and

(5) be licensed to practice dentistry in Texas and in good standing with the Texas State Board of Dental Examiners. Prospective providers under suspension by the licensing board will not be approved to participate in the program.

§49.11.Provider Application and Contract.

A prospective provider who meets the criteria for participation in the program, as described in §49.10 of this title (relating to Provider Participation Requirements), is eligible to contract with the department to provide oral health treatment services. To apply for program participation, a prospective provider must, after receiving information on the program including the schedule of current fees, sign a letter of agreement (contract) with the department. After the contract is properly executed, the prospective provider will be provided written notice of approval to participate in the program and a copy of the program Manual.

§49.12.Provider Termination.

(a) The contract between the provider and the department may be terminated without cause by either party with 30 days written notice. The department may modify, suspend, or terminate the contract of any provider from the program for due cause. Due cause includes but is not limited to:

(1) breach of contract;

(2) suspension or revocation of the provider's license by the Texas State Board of Dental Examiners;

(3) disciplinary action(s) taken by the Texas State Board of Dental Examiners;

(4) submission of false or fraudulent claims;

(5) amendment or judicial interpretation of federal or state laws or other requirements in a way that would make it infeasible or impossible for either party to fulfill the agreement, or if either party is unable to agree on changes necessary for continuation of the agreement;

(6) any violation of program policies, procedures, rules, or requirements; or

(7) any other reason authorized by rule, regulation, statute, or contract.

(b) An administrative review and due process hearing is available to any provider for the resolution of conflict between the department and the provider in accordance with Subchapter D of this chapter (relating to Appeals Process).

(c) The department may not terminate a contract during the pendency of a hearing. The department may withhold payments during the pendency of a hearing, but the department must pay the withheld payments and resume contract payments if the final determination is favorable to the provider.

(d) Subsections (b) and (c) of this section do not apply if a contract is canceled by the department because of exhaustion of funds, if the contract expires according to its terms, or if the contract is canceled because program services are restricted or eliminated due to limited or unavailable funds.

§49.13.Treatment Services by Non-Providers.

The department may pay a non-provider for emergency care, in accordance with program policies, procedures, and the Manual, in cases where program providers are not available or able to provide the emergency care and when delay in providing care would be detrimental to the recipient's health.

§49.14.Payment of Claims.

(a) Payment will not be made to providers or non-providers for services not authorized in accordance with program policies, procedures, the Manual, and the rules in this chapter. Payment for any service may be made only after the service has been delivered.

(b) Provider claims will be processed and considered for payment in accordance with program policies, procedures, and the Manual. Claims will be denied if the claim:

(1) contains incomplete or inaccurate information; or

(2) is not submitted in accordance with program policies, procedures, and the Manual.

(c) A provider claim that has been denied may be reconsidered for payment if the provider requests an administrative review, as described in §49.16 of this title (relating to Administrative Review). In order to receive an administrative review of the denied claim, the provider must request the administrative review in writing and return the claim, with the alleged error identified, to the OHP no later than 20 business days after the date of the notice of denial, accompanied by appropriate documentation for review.

§49.15.Administrative Sanctions.

Any provider who fails to provide and maintain quality services or dentally accepted standards, or who violates program policies, procedures, the Manual, or the rules in this chapter, may be subject to administrative sanctions, as determined appropriate by the state dental director, in accordance with program policies and procedures. A provider may request an administrative review, as described in §49.16 of this title (relating to Administrative Review), if a written request is received by the OHP no later than 20 business days after the date of the notice of administrative sanction.

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

Filed with the Office of the Secretary of State on June 2, 2008.

TRD-200802833

Lisa Hernandez

General Counsel

Department of State Health Services

Earliest possible date of adoption: July 13, 2008

For further information, please call: (512) 458-7111 x6972

SUBCHAPTER D. APPEALS PROCESS

25 TAC §§49.16 - 49.18

STATUTORY AUTHORITY

The proposed new sections affect Health and Safety Code, Chapters 43 and 1001; and Government Code, Chapter 531.

§49.16.Administrative Review.

(a) An administrative review is available under the following circumstances:

(1) an applicant or recipient receives notice of a proposed action; or

(2) a provider receives notice of an administrative sanction, conflict, or denied claim.

(b) No later than 20 business days after the date of notice of the action, conflict, sanction, or claim denial, the aggrieved person may request an administrative review. The request must be made in writing and received by the OHP within the required timeframe. Additional information bearing on the decision to be reviewed may be submitted at this time. Failure to make a timely request for an administrative review is deemed to be a waiver of the right to administrative review.

(c) Upon timely receipt of a request for an administrative review, an administrative review team will review and consider all relevant materials submitted by the program and the aggrieved person. The administrative review team will affirm or reverse the decision being appealed and respond in writing to the aggrieved person, giving the reason(s) for the decision.

§49.17.Due Process Hearing.

(a) A due process hearing is available under the following circumstances:

(1) an applicant or recipient receives notice of a proposed action or an administrative review team decision that supports the department; or

(2) a provider receives notice of a conflict with the department or an administrative review team decision that supports the department regarding a conflict.

(b) A request for a due process hearing is not contingent upon initially requesting an administrative review. If a request for a hearing is made without first requesting an administrative review, the right to an administrative review is deemed to be waived.

(c) A request for a due process hearing must be made in writing and received by the OHP no later than 20 business days after the date of the notice or decision that the aggrieved person wants to appeal, as described in subsection (a) of this section. Failure to make a timely request for a due process hearing is deemed to be a waiver of the right to a due process hearing and the department's decision is upheld and implemented.

§49.18.Hearing Process.

(a) Upon receiving a written request for a due process hearing, the department will assign a hearing examiner who will set a date, time, and place for the hearing. The hearing will not be conducted under the contested case provisions of the Administrative Procedure Act, Texas Government Code, Chapter 2001, but will include the following:

(1) a written notice to the aggrieved person of the matters asserted and the basis for the proposed action or conflict;

(2) an opportunity for the aggrieved person to receive a fair hearing by a hearing examiner, either by telephone conference call or in person, under §§1.51 - 1.55 of this title (relating to Fair Hearing Procedures);

(3) an opportunity for the aggrieved person to be represented by counsel or other representative;

(4) an opportunity for the aggrieved person or his/her representative to be heard in person, to call witnesses, and to present documentary evidence;

(5) an opportunity for the aggrieved person to cross-examine witnesses;

(6) a written recommendation by the hearing examiner to the commissioner, setting forth the reasons for the recommendation and the evidence upon which the recommendation is based; and

(7) the final written decision to be made by the commissioner.

(b) The department's administrative decision is final in a due process hearing and is not subject to further appeal.

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

Filed with the Office of the Secretary of State on June 2, 2008.

TRD-200802834

Lisa Hernandez

General Counsel

Department of State Health Services

Earliest possible date of adoption: July 13, 2008

For further information, please call: (512) 458-7111 x6972

CHAPTER 421. HEALTH CARE INFORMATION

SUBCHAPTER D. COLLECTION AND RELEASE OF OUTPATIENT SURGICAL AND RADIOLOGICAL PROCEDURES AT HOSPITALS AND AMBULATORY SURGICAL CENTERS

25 TAC §§421.61 - 421.68

The Executive Commissioner of the Health and Human Services Commission, on behalf of the Department of State Health Services (department), proposes amendments to §§421.61 - 421.67, and new §421.68 concerning the collection and release of patient level data relating to patients that have surgical procedures or radiological procedures (under specified revenue codes) performed in Texas hospitals (as an outpatient service including in the emergency department) or ambulatory surgical centers.

BACKGROUND AND PURPOSE

Sections 421.61 - 421.67 relate to the collection and release of ambulatory surgical care and emergency department data on reporting hospitals. The sections were previously adopted as a voluntary submission process to the department. The department did not collect any data from hospital outpatient services or emergency department services because grant funds were requested, but not awarded to the department for this data collection. The rules were originally developed and adopted by the Texas Health Care Information Council (council) and were transferred to the Department of State Health Services on September 1, 2004, as a result of the consolidation of health and human services agencies under House Bill 2292 (HB 2292), 78th Texas Legislature, 2003.

The proposed rules are necessary to comply with Sections 2 and 3, Senate Bill 1731 (SB 1731), 80th Texas Legislature, 2007, amending the Health and Safety Code, Chapter 108. Chapter 108 requires the Executive Commissioner to adopt rules to implement the collection and release of data from health care facilities. Section 2 added "free-standing imaging center" to the list of facilities included under the term "Health Care Facility" in Health and Safety Code, §108.002(10), thereby authorizing the department to collect data from free-standing imaging centers which are neither defined nor licensed by the state. Section 3 amended Health and Safety Code, §108.009(k), and established the prioritization of data collection efforts for the department as "inpatient and outpatient surgical and radiological procedures from hospitals, ambulatory surgical centers, and free-standing radiology centers." The proposed amendments and new section do not address or include language requiring the collection of data from free-standing imaging centers, but does require submission of select revenue codes that include surgical and radiological procedures from hospitals and ambulatory surgical centers. The proposed amendments to §§421.61 - 421.67 establish rules regarding the submission, correction, certification requirements and the new §421.68 provides rules regarding the release specifications of select revenue codes which cover surgical procedures or radiological procedures occurring in hospitals or ambulatory surgical centers.

Health and Safety Code, §108.009(h), requires the department to accept data in data submission formats used by hospitals and other providers and to use the format developed by the National Uniform Billing Committee (Uniform Hospital Billing Form UB 92) and HCFA-1500 (Health Care Financing Administration Form 1500) or their successors or other universally accepted standardized forms. The UB 04 is the successor to the UB 92 and the CMS-1500 (Centers for Medicare and Medicaid Services Form 1500) is the successor to the HCFA-1500. These are paper forms of the patient claims, CMS has discouraged the use and submission of paper based claims. The federal government, CMS and the State of Texas have encouraged the submission of electronic data, including Medicare claims as a result of the regulations and amendments to the Paperwork Reduction Act, Printing Act, and the Government Printing Office Electronic Information Access Enhancement Act of 1993 (Public Law 103 - 40), which have extended the definition of government publications beyond paper formats. The proposed amendments require hospitals and ambulatory surgical centers to submit data in HIPAA (Health Insurance Portability and Accountability Act of 1996, Public Law 104 - 191, 104th Congress) compatible formats, which are modified to collect patient race and ethnicity. The current accepted standardized forms are approved through federal transaction and code sets regulations under HIPAA. Those versions are the American National Standards Institute, Accredited Standards Committee X12N, 837 Health Care Institutional Claim Implementation Guide (ANSI 837 Institutional Guide) and American National Standards Institute, Accredited Standards Committee X12N, 837 Health Care Professional Claim Implementation Guide (ANSI 837 Professional Guide). The current approved version of the ANSI 837 Institutional Guide is Version 4, Release 1, Sub-release 0, Transmission Type X096 with Addendum 1, 004010X096A1, and the approved version for the ANSI 837 Professional Guide is 004010X098A1.

Health and Safety Code, §108.009(k) requires the department to collect health care data elements relating to the racial and ethnic background of patients. These data elements are not routinely collected or reported on the standardized claim forms. The current HIPAA compliant 4010A1 versions of ANSI 837 Institutional Guide and ANSI 837 Professional Guide have a data element field listed for Race or Ethnicity Code (DMG05), and it is marked as "Not Used" (for billing) in the manuals printed by the Washington Publishing Company. The ANSI 4010A1 data translators (software that reads and interprets the code) only allow for one character in the field. The department requires for hospital inpatient data submissions under §421.9(c)(1) of this title that the "Race Code" be submitted in this location. The patient ethnicity code is reported in the NTE02 data field for hospital inpatient data under §421.9(c)(2) of this title, which is marked as a "Situational" (submission is required sometimes and dependent upon additional criteria) data field.

In the proposed amendment, the department will collect race and ethnicity by requiring the same codes and locations as required by the current hospital inpatient data submission rules. The department has not received or heard of any reported incidences of claims rejected for facilities submitting to third party payers that included these data elements on the billing claim. The department anticipates modifying the rules regarding the collection of the patient race and ethnicity codes after federal approval of other versions of the ANSI 837 Institutional Guide or ANSI 837 Professional Guide. The next versions will expand the number of characters because the United States Office Management and Budget (OMB) recommended that multiple race codes be allowed and collected for data analysis. The proposed amendments allow for matching to the code set recommended by OMB, except that Hawaiian - Pacific Islanders are included with the Asian race code (2). The latest United States Census information (2006) indicates that Hawaiian - Pacific Islanders are approximately 0.1 percent of the Texas population (http://quickfacts.census.gov/qfd/states/48000.html). The department anticipates expanding the list in the future to include all federally approved codes. Expansion of the list will allow facilities to be more precise in their reporting and will allow the data to be classified into the more basic categories as research requires or allows.

Health and Safety Code, §108.009(i), requires the department to develop reasonable alternate data submission procedures for providers that do not possess electronic data processing capacity. The department knows of no facilities that are without electronic data processing capabilities. One facility reported that they did not have an electronic billing system. Several facilities have expressed concern that they do not have the ability to transfer data over the secured Internet connections or direct connections with the department's contract vendor who receives and processes the data. The department's contract vendor will provide free data entry software that can be utilized by the facilities to create an electronic data submission file that can be encrypted and placed on electronic media, (e.g., CD (Computer Disk), or other department approved portable electronic media), that can be mailed to the contract vendor or transferred via telephone using a computer MODEM (Modulator/demodulator - an electronic device for converting between serial data from a computer and an audio signal suitable for transmission over a telephone line connected to another modem).

The definition of "public use data" in Health and Safety Code, Chapter 108, requires that the data be severity and risk adjusted. The department is not aware of any severity and risk adjustment methodology software for outpatient data that assigns risk and severity scores to outpatient data for public data release. The department has investigated three products from 3M™, the "Ambulatory Patient Classification" (APC) software, Ambulatory Patient Group (APG) software and Clinical Risk Group (CRG) software and one product from the Agency for Healthcare Research an Quality (AHRQ) has a Clinical Classifications Software and each provide adjustment information regarding outpatient data that can be useful to the public, policy makers and health data researchers. Therefore, those data elements are included in the list of data elements to be included in the public use data file in new §421.68. The department requests that commenters submit recommendations regarding such methodologies or procedures.

Health and Safety Code, §108.009, requires providers to submit data as required by these sections. The HIPAA privacy regulations at 45 Code of Federal Regulations, §164.512(a), allow health care providers to disclose protected health information without a patient's consent or authorization when disclosure is required by law. Since state law requires disclosure to the department, the HIPAA regulations allow the submission of the data.

The data cannot be required to be submitted to the department before the 90th day after the date the rules are adopted and must take effect not later than the first anniversary after the date the rules are adopted.

Government Code, §2001.039, requires that each state agency review and consider for readoption each rule adopted by that agency pursuant to the Government Code, Chapter 2001 (Administrative Procedure Act). Sections 421.61 - 421.67 have been reviewed and the department has determined that reasons for adopting the sections continue to exist because rules on this subject are needed.

SECTION-BY-SECTION SUMMARY

In response to the consolidation of the council into the department, the term "Council" is replaced with the term "DSHS" throughout the sections and the referenced section numbers are updated throughout to reflect the numbers assigned when the rules were transferred to the department in 2004.

Throughout the sections the term "reporting hospital" is replaced with "facility" and "reporting hospitals" replaced with "facilities."

Section 421.61, Definitions, is amended by adding the following new terms and definitions to clarify new language: "Ambulatory surgical center," "Anesthetized patient," "ANSI 837 Professional Guide," "APG," "CRG," "Other Provider," "Outpatient," "Referring Provider" or Referring Other Health Professional," and "Rendering Provider" or "Rendering Other Health Professional."

The following terms and definitions were deleted because the terms were deleted from this subchapter are no longer used or necessary: "Attending physician," "Council," "CPT," "Discharge," "DRG," "Executive Director," "Panel," "Reporting hospital," "Scientific Review Panel" and "TDH."

The following term descriptions are amended: "Certification file" adds a clarifying statement regarding the contents of the file; "Certification Process" updates the title of the reference section; "Clinical Classifications Software" adds clarifying language regarding the developer of the software; "Event claim" removes the section title name of the reference section and adds reference to the ANSI 837 Professional Guide; "Event file" removes the section title name of the reference section and adds the phrase "and ANSI 837 Professional Guide" as a reference for the terms usage; "Facility" adds ambulatory surgical centers to hospitals as being required to report under this subchapter; "Facility Type Indicators" adds ambulatory surgical centers to the list of indicators which provide information to the data user regarding the type of health services provided by the facility; "Geographic identifiers" changes the phrase "public health region" to "health service region" in response to departmental terminology for the region; "HCPCS" updates changes at the United States Department of Health and Human Services and adds a clarifying statement that "Current Procedural Terminology" (CPT) codes which are maintained by the American Medical Association (AMA) are "Level 1" HCPCS codes; "Hospital" updates the referenced section; "IRB" adds clarifying language regarding the composition of the IRB and their role regarding release of outpatient event data; "Operating or Other Physician" updates agency name and adds the phrase "or radiological" between "surgical" and "procedure"; in "Physician" the Latin phrase "et seq." is added to the legal citation; "Public use data file" adds the phrase "For the purposes of this subchapter" to the description and removes the reference to ambulatory surgical care and emergency department, because the subchapter addresses the types of data in the file; "Required minimum data set" adds clarifying language about the ANSI 837 Institutional Guide and ANSI 837 Professional Guide, updates the referenced sections and removes language that is no longer necessary; "Research data file" updates language to the current policy regarding research data release; "Submission" updates referenced rule section and removes the title name in accordance with administrative format guidelines; in "THCIC Identification Number" a clarifying statement is added regarding the assignment of the distinguishable identifier for multiple location facilities under one license number; and, "Uniform physician identifier" adds clarifying language regarding the assignment of a uniform physician identifier for this title.

Section 421.62 is amended to include hospital outpatient and ambulatory surgical center data. Hospitals and ambulatory surgical centers will be required to report data to the department. The data to be reported will be determined by what surgical procedures or radiological services are covered by the revenue codes specified in §421.67(f) and were received by a patient of the facility. Also, the sectioned names in the referenced rules are revised to reflect the correct rule information and administrative format guidelines.

Section 421.63(a) is amended to use defined terms regarding outpatient data submission. Section 421.63(b) is amended to clarify that a delay in the due date requirements is allowed upon a timely written request until the department renders a decision regarding the delay request.

Section 421.64 is amended to revise the section name of the referenced section in accordance with administrative format guidelines. An alternative data submission method is added for submitting the required minimum data set on events required by this chapter. This alternative method requires that the facilities and the media be approved by the department prior to submission of the data file.

Section 421.65 is amended to revise section names of referenced sections in accordance with administrative format guidelines.

Section 421.66(c)(3) is amended to state which outpatient data is being certified by the facility and rule references were revised.

Section 421.67(a) is amended to specify that data could be submitted in either the modified ANSI 837 Institutional Guide format or the ANSI 837 Professional Guide format. The department intends to follow as closely as possible the HIPAA transaction and code set guidelines as allowable in order to fulfill the mandate in Health and Safety Code, Chapter 108, to use accepted standardized formats.

Section 421.67(c) is amended to include the ANSI 837 Professional Guide as a valid data format for submitting the required data elements to DSHS and clarify that the format may change in response to changes in state law or federal legislative or federal regulation requirements. A clarifying statement is added in §421.67(c)(3) for the submission of External Cause of Injury codes (E-codes) in the ANSI 837 Professional Guide. In §421.67(c)(4)(C) clarifying language is added to reference the corresponding Loops in the ANSI 837 Institutional Guide and the ANSI 837 Professional Guide for the "Service Facility Provider" identification number.

Section 421.67(d) is amended to state the required minimum data set for facilities that provide one or more of the services that are included under the revenue codes specified in §421.67(f) of this title for patients which are uninsured, considered as self pay, or are covered by a third-party payer which requires the facility to submit a claim in an ANSI 837 Institutional Guide format or CMS-1450 format.

Section 421.67(e) specifies the required minimum data set for facilities that provide one or more of the services that are included under the revenue codes specified in §421.67(f) of this title for patients for whom the third-party payer requires the claim to be submitted in the ANSI 837 Professional Guide format or the CMS-1500 format. Language is added to provide a facility the option of submitting to the department the required minimum data set specified in §421.67(d) instead of the modified ANSI 837 Professional Guide format.

Section 421.67(f) is added to specify revenue codes, which cover surgical and radiological procedures of outpatients whose data shall be submitted to the department in compliance with this subchapter.

New §421.68 establishes rules regarding the protection of patient and physician identifying data and release of event data collected under this subchapter as mandated by Health and Safety Code, Chapter 108.

FISCAL NOTE

Ramdas Menon, Ph.D., Director, Center for Health Statistics, has determined that for each calendar year of the first five years that the sections are in effect, there will be fiscal implications to the state as a result of enforcing or administering the sections as proposed. The effect on state government will be a one time cost to the department of $486,000 for development and modification of the current health care data collection system (data file format, file structures, logs, reports and three associated data software tools) and the University of Texas Medical Branch at Galveston (UTMB) stated a one time cost of $10,000 for programming to submit the data as required by the proposed rule. The following four years there will be $1,516,297 (average of $379,000 per year, including a three percent increase per year) additional costs to the department. The Texas Center for Infectious Disease stated that there would be $350 per year in additional costs: Harris County Psychiatric Center stated no additional costs would be incurred. The other state facilities provided no estimate of costs.

The fiscal implications of submitting the patient level data for the surgical procedures or radiological procedure codes covered by the specified revenue codes in §421.67(f) and associated data as proposed for local governments that own or operate hospitals or ambulatory surgical centers will vary dependent on the complexity of the hospital's or ambulatory surgical center's information technology and contract requirements with any vendors involved in their information systems process. No cost estimates were received from local government entities. The department estimates that costs for local government entities may range from no additional costs up to a similar one-time cost of $10,000 as submitted by UTMB.

SMALL AND MICRO-BUSINESS IMPACT ANALYSIS AND ECONOMIC IMPACT TO PERSONS

Dr. Menon anticipates that those hospitals or ambulatory surgical centers required to report under Health and Safety Code, Chapter 108, and these sections will incur costs dependent upon the complexity and status of their information systems. Hospitals and ambulatory surgical centers that do not collect racial and ethnic background information on their patients who receive the surgical services or radiological services covered under the revenue codes specified in the sections or do not submit data electronically will incur additional costs dependent on the complexity of their information technology system. Rural hospitals are exempt from reporting; therefore, rural hospitals that might qualify as a small business or micro-business are not included in this analysis.

Based on licensure records held by the department and department staff knowledge of hospitals and ambulatory surgical centers in Texas, the department believes that the number of hospitals and ambulatory surgical centers (ASC) that are small businesses (for-profit, independently owned, and under 100 employees or under $6 million in annual gross receipts) is approximately 170. The department is not aware of any hospitals (not including rural hospitals) that are micro-businesses (for-profit, independently owned, and under 20 employees). The department believes that the number of ambulatory surgical centers that are small businesses or micro-businesses is approximately 69.

Dr. Menon anticipates that hospitals and ambulatory surgical centers that are required to submit data will modify or have modified their computer systems to capture and submit the data. The hospitals and ambulatory surgical centers that are small businesses or micro-businesses that contract with a vendor or have built a computer system that is separate from their billing system will incur varying costs. These costs depend upon the complexity of their systems and contract requirements with any vendors involved with the hospital's or ambulatory surgical center's information technology systems for submitting the data, in particular the racial and ethnic background indicator codes as proposed.

Licensed hospitals and ambulatory surgical centers were contacted, several ambulatory surgical centers, which are small businesses or micro-businesses provided a cost estimate as requested by the department. Two facilities responded that there would be no significant costs. One facility responded that it would cost about $40,500 for hardware and software to comply with the requirements in the proposed rules, because their current software system did not collect many of the data elements proposed. The cost estimate included a new server and new software, but did not include programming costs to collect ethnicity. One facility stated their vendor costs would be $500 for first year and $200 in maintenance costs. One facility reported a one-time cost of $3,000 and minimal ongoing costs. One facility responded that they would incur costs from $3000 to $4000. One facility provided a cost estimate of $5,500 for initial development and $11,856 for annual costs to report the required data to the data under the proposed amendments. One facility reported that it would require $9,800 for a software upgrade and $4,500 for printing and storing the new form to collect race/ethnic data elements, and training for staff, and an annual maintenance charge of $1,700 and $5,500 for the office manager to verify and correct the data. One facility responded that they would have a one-time cost of $16,000 and annual costs of $16,000. One facility responded they would have one time cost of $17,500. One facility reported that it would cost them $50,000 for the first year and $35,000 each year thereafter, citing they would need to hire a person just to collect and submit the data. One ambulatory surgery center estimated that it would cost $65,000 the first year with $40,000 in annually for personnel and maintenance costs to comply with the proposed amendments. One facility provided a cost estimate of $220,000 stating it is to upgrade their server and computer network to handle the software applications and they would require $125,000 in personnel and maintenance costs; however the costs appear to include much more than is required by the proposed rules. For example, the cost estimate appears to include a new server and network that the department does not believe would be necessitated because of the rules. The department is unable to determine how much of this cost estimate relates directly to implementation of the rules as proposed. The small hospitals contacted did not provide any cost estimates or did not meet the criteria of a small business or micro-business. Based on this information, the department estimates that the economic impact of the sections on hospitals and ambulatory surgical centers that are small businesses or micro-businesses will range from no additional costs to an estimated $65,000 for first year costs with approximately $40,000 per subsequent year on personnel and maintenance costs.

The department considered alternative methods of achieving the purposes of the proposed sections. The purposes of the sections could be broadly stated as enhancing the ability of the state and the department to collect data for analysis to assist the public in making informed choices when selecting a hospital or ambulatory surgical center for services. One alternative could be to not collect the outpatient data that will be required by these sections; in other words, not propose or adopt any new sections or amendments to these sections. Under that alternative, the department would continue to only collect the inpatient hospital data that it currently collects. While this alternative would provide the public with the current data to help the public make choices, it would not provide any new data to the public on hospital outpatient services and would provide no data on ambulatory surgical center services. In addition SB 1731 mandated prioritization of data collection efforts of the department as to inpatient and outpatient surgical and radiological procedures from hospital, ambulatory surgical centers, and free-standing radiology centers. The Texas Legislature appropriated funds for additional data collection, which funds are estimated by the department to be sufficient for the outpatient data collection and analysis mandated by these sections for hospitals and ambulatory surgical centers. This alternative was not accepted.

Another alternative could be to collect only hospital outpatient data but not ambulatory surgical center outpatient data. While this alternative would provide the public with the current data to help the public make choices and new data on hospital outpatient services, it would not provide any data on ambulatory surgical center services. In addition SB 1731 mandated prioritization of data collection efforts of the department as to inpatient and outpatient surgical and radiological procedures from hospital, ambulatory surgical centers, and free-standing radiology centers. The Texas Legislature appropriated funds for additional data collection, which funds are estimated by the department to be sufficient for the outpatient data collection and analysis mandated by these sections for hospitals and ambulatory surgical centers. This alternative was not accepted.

A third alternative could be to collect data based on procedures codes, rather than revenue codes. In meetings and discussions with stakeholders representing hospitals and ambulatory surgical centers, the department was requested by the stakeholders to use revenue codes because revenue codes would change fewer times than procedure codes and require fewer rule amendments and information system changes. Use of either type of codes would meet the purposes of these sections. The alternative of using procedures codes was not accepted because of the stated preference of the stakeholders.

The anticipated economic costs to persons (hospitals or ambulatory surgical centers that are required to report under Health and Safety Code, Chapter 108) who are required to comply with the sections as proposed will be dependent upon the complexity and status of their information systems and will range from no additional costs to an estimated $65,000 for the first year. The annual costs thereafter would range from zero to $40,000.

There will be little effect on local employment. The department assumes that any person hired would be hired in the first year that the rules are in effect. No additional local employment is anticipated in the subsequent years. Several facilities stated they would need to hire one full time person to collect and submit the data.

PUBLIC BENEFIT

Dr. Menon has also determined that for each year of the first five years the sections are in effect, the public will benefit from the adoption of the amended sections. The public benefit anticipated as a result of collecting and reporting of this data is the ability to provide the public with data and information regarding the type of surgical services or radiological services, volume, average charges, and the complexity of patient services provided by the hospitals or ambulatory surgical centers. The public will benefit from health care provider reports and information about the quality of care being provided by hospital outpatient surgical services and ambulatory surgical centers. The standardized data and the reports and information developed by the department from the data will assist the consumer in making informed decisions on healthcare issues. The public will also benefit by having these rules updated to reflect the current organization of the department.

REGULATORY ANALYSIS

The department has determined that the proposal is not a "major environmental rule" as defined by Government Code, §2001.0225. "Major environmental rule" is defined to mean a rule the specific intent of which is to protect the environment or reduce risk to human health from environmental exposure and that may adversely affect, in a material way, the economy, a sector of the economy, productivity, competition, jobs, the environment or the public health and safety of a state or a sector of the state. The proposal is not specifically intended to protect the environment or reduce risks to human health from environmental exposure.

TAKINGS IMPACT ASSESSMENT

The department has determined that the proposed rules do not restrict or limit an owner's right to his or her property that would otherwise exist in the absence of government action and, therefore, do not constitute a taking under Government Code, §2007.043.

PUBLIC COMMENT

Comments on the proposal may be submitted to Bruce M. Burns, D.C., Center for Health Statistics, Department of State Health Services, Mail Code - 1898, P.O. Box 149347, Austin, TX 78714-9347, Fax (512) 458-7740. Comments will be accepted for 30 days following publication of the proposal in the Texas Register.

LEGAL CERTIFICATION

STATUTORY AUTHORITY

The proposed amendments and new rule are authorized by Health and Safety Code, §§108.006, 108.009, 108.010, 108.011 and 108.013, which require the Executive Commissioner to adopt rules necessary to carry out Chapter 108 including rules on data collection requirements, to prescribe the process of data submission, to implement a methodology to collect and disseminate data reflecting provider quality, to specify data elements to be required for submission to the department and which data elements are to be released in a outpatient event public use data file; and Government Code, §531.0055, and Health and Safety Code, §1001.075, which authorize the Executive Commissioner to adopt rules and policies necessary for the operation and provision of health and human services by the department and for the administration of Health and Safety Code, Chapter 1001. Review of the rules implements Government Code, §2001.039.

The proposed amendments and new rule affect the Health and Safety Code, Chapters 108 and 1001; and Government Code, Chapter 531.

§421.61.Definitions.

The following words and terms, when used in this subchapter, shall have the following meanings, unless the context clearly indicates otherwise.

(1) (No change.)

(2) Ambulatory Surgical Care Data--Data for events associated with facility [~~reporting hospital~~] services, which require surgery to be performed in an operating room on an anesthetized patient.

(3) Ambulatory surgical center--An establishment licensed as an ambulatory surgical center under the Health and Safety Code, Chapter 243.

(4) Anesthetized patient--For the purposes of this subchapter, an outpatient who receives an anesthetic (a substance that reduces sensitivity, feeling, or awareness to pain or bodily sensations or renders the patient unconscious) prior to surgical services from a hospital or ambulatory surgical center.

(5) [~~(3)~~ ] ANSI 837 Institutional Guide--American National Standards Institute, Accredited Standards Committee X12N, 837 Health Care Institutional Claim Implementation Guide.

(6) ANSI 837 Professional Guide--American National Standards Institute, Accredited Standards Committee X12N, 837 Health Care Professional Claim Implementation Guide.

(7) [~~(4)~~] APC--Ambulatory Payment Classification.

(8) APG - Ambulatory Patient Group (APG)--A prospective payment system (PPS) for hospital-based outpatient care developed by 3M™. APGs provide information regarding the kinds and amounts of resources utilized in an outpatient visit and classify patients with similar clinical characteristics.

[(5) Attending Physician--The individual licensed under the Medical Practice Act (Occupations Code, Chapter 151) who would normally be expected to certify and recertify the medical necessity of the services rendered during the hospital episode.]

(9) [~~(6)~~] Audit--An electronic standardized process developed and implemented by DSHS to identify potential errors and mistakes in file structure format or data element content by reviewing data fields for the presence or absence of data and the accuracy and appropriateness of data.

(10) [~~(7)~~] Certification File--One or more electronic files (may include reports concerning the data and its compilation process) compiled by DSHS that contain one record for each patient event which has at least one procedure covered in the revenue codes specified in §421.67(f) of this title (relating to Event Files--Records, Data Fields and Codes) submitted for each facility [~~reporting hospital~~] under this subchapter during the reporting quarter and may contain one record for any patient event occurring during one prior reporting quarter for whom additional event claims have been received.

(11) [~~(8)~~] Certification Process--The process by which a provider confirms the accuracy and completeness of the certification file required to produce the public use data file as specified in §421.66 [~~§1301.66~~] of this title (relating to Certification of Compiled Event Data).

(12) [~~(9)~~] Charge--The amount billed by a provider for specific procedures or services provided to a patient before any adjustment for contractual allowances, government mandated fee schedules or write offs for charity care, bad debt or administrative courtesy. The term does not include co-payments charged to health maintenance organization enrollees by providers paid by capitation or salary in a health maintenance organization.

(13) [~~(10)~~] Clinical Classifications [ ~~Classification~~] Software--A classification system that groups diagnoses and procedures into a limited number of clinically meaningful categories developed at the United States Department of Health and Human Services, Agency for Healthcare Research and Quality (AHRQ).

(14) CRG--Clinical Risk Grouping software which classifies individuals into mutually exclusive categories and, using claims data, assigns the patient to a severity level if they have a chronic health condition. Developed by 3M™ Corporation.

(15) [~~(11)~~] Comments--The notes or explanations submitted by the facilities [ ~~reporting hospitals~~ ], physicians or other health professionals concerning the provider quality reports or the encounter data for public use as described in the Texas Health and Safety Code, §108.010(c) and (e) and §108.011(g) respectively.

~~[(12) Council--The Texas Health Care Information Council, until the abolition of the Council, the Department of State Health Services after abolition of the Council.]~~

~~[(13) CPT--Current Procedural Terminology.]~~

(16) [~~(14)~~] Data format--The sequence or location of data elements in an electronic record according to prescribed specifications.

[(15) Discharge--The formal release of a patient by a physician authorized to practice in a reporting hospital ambulatory surgical unit or emergency department; that is, the termination of a period of medical services by death or by disposition to a residence or another health care provider.]

(17) [~~(16)~~] DSHS--Department of State Health Services, the successor state agency to the Texas Health Care Information Council and the Texas Department of Health.

~~[(17) DRG--Diagnosis Related Group.]~~

(18) - (19) (No change.)

(20) Emergency Department--Department or room within a [~~reporting~~] hospital as determined by federal or state law for the provision of emergency health care.

(21) - (22) (No change.)

(23) Ethnicity--The status of patients relative to Hispanic background. Facilities [~~Reporting hospitals~~] shall report this data element according to the following ethnic types: Hispanic or Non-Hispanic.

(24) Event--The medical screening examination, triage, observation, diagnosis or treatment of a patient within the authority of a facility [~~reporting hospital~~].

(25) Event claim--A set of computer records as specified in §421.67 [~~§1301.68~~] of this title [ ~~(relating to Event Files--Records, Data Fields and Codes)~~] relating to a specific patient. "Event claim" corresponds to the ANSI 837 Institutional Guide and ANSI 837 Professional Guide term, "Transaction set."

(26) Event file--A computer file as defined in §421.67 [~~§1301.68~~] of this title [ ~~(relating to Event Files--Records, Data Fields and Codes)~~ ] periodically submitted on or on behalf of a facility [ ~~reporting hospital~~] in compliance with the provisions of this subchapter. "Event File" corresponds to the ANSI 837 Institutional Guide and ANSI 837 Professional Guide terms, "Communication Envelope" or "Interchange Envelope."

~~[(27) Executive director--The chief administrative officer of the Council or of the department designated by the Department of State Health Services to perform the functions of the Council.]~~

(27) [~~(28)~~] Facility--For the purposes of this subchapter a facility is a [~~reporting~~] hospital or ambulatory surgical center, required to report under the Health and Safety Code, Chapter 108 and this subchapter.

(28) [~~(29)~~] Facility Type Indicators--An indicator that provides information to the data user as to the type of facility or the primary health services delivered at that [ ~~reporting~~ ] hospital (e.g., Hospital based ambulatory surgical unit and hospitals with an emergency department or emergency room) and ambulatory surgical centers. A facility [ ~~hospital~~] may have more than one indicator.

(29) [~~(30)~~] Geographic identifiers--A set of codes indicating the [~~public~~] health service region and county in which the patient resides.

(30) [~~(31)~~] HCPCS--Healthcare [ ~~HCFA's~~] Common Procedure Coding System of the [ ~~(HCFA-Health Care Finance Administrations (Now called~~ ] Centers for Medicare and Medicaid Services[))]. This includes the "Current Procedural Terminology" (CPT) codes (maintained by the "American Medical Association" (AMA)), which are "Level 1" HCPCS codes.

(31) [~~(32)~~] HIPPS--Health Insurance Prospective Payment System.

(32) [~~(33)~~] Hospital--A public, for-profit, or nonprofit institution licensed as a general or special hospital (25 TAC, §133.2(21)) of this title [ ~~(25 TAC §133.2(22)(52))~~], or a hospital owned by the state.

(33) [~~(34)~~] ICD--International Classification of Disease.

(34) [~~(35)~~] IRB--Institutional Review Board composed of DSHS' appointees or agents who have experience and expertise in ethics, patient confidentiality, and health care data who review and approve or disapprove requests for data or information other than the outpatient event public use data.

(35) [~~(36)~~] Operating or Other Physician--The "physician" licensed by the Texas Medical Board [ ~~Texas State Board of Medical Examiners~~ ], or "other health professional" licensed by the State of Texas who performed the principal procedure or performed the surgical or radiological procedure most closely related to the principal diagnosis.

(36) [~~(37)~~] Other health professional--A person licensed to provide health care services other than a physician. An individual other than a physician who provides diagnostic or therapeutic procedures to patients. The term encompasses persons licensed under various Texas practice statutes, such as psychologists, chiropractors, dentists, nurse practitioners, nurse midwives, and podiatrists who are authorized by the facilities [~~reporting hospital~~] to examine, observe or treat patients.

(37) Other Provider--For the purposes of reporting on the modified ANSI 837 Institutional Guide, the physician or other health professional who performed the principal surgical or radiological procedure on the patient for the event if they are not reported as the operating physician or other physician. In the case where a substitute provider (locum tenens) is used, that physician or other health professional shall be submitted as specified in this subchapter.

(38) Outpatient or patient--For the purposes of this subchapter a patient who receives surgical or radiological services from an ambulatory surgical center or a patient who receives surgical or radiological services from a hospital and is not admitted to a hospital for inpatient services. Outpatients include patients who receive one or more services covered by the revenue codes that are specified in §421.67(f) of this title, which may occur in the emergency department, ambulatory care, radiological, imaging or other types of hospital units. Outpatient includes a patient who is transferred from an ambulatory surgical center to another facility or a hospital patient who is under observation and not admitted to the hospital.

~~[(38) Panel--Scientific Review Panel.]~~

(39) Patient account number--A number assigned to each patient by the facility [~~hospital~~], which appears on each computer record in a patient event claim. This number is not consistent for a given patient from one facility [ ~~hospital~~] to the next, or from one admission to the next in the same facility [~~hospital~~ ]. DSHS will delete or encrypt this number to protect patient confidentiality prior to release of data.

(40) Physician--An individual licensed under the laws of this state to practice medicine under the Medical Practice Act, Occupations Code, Chapter 151 et seq.

(41) Provider--For the purposes of this subchapter, a physician or facility [~~reporting hospital~~].

(42) Public use data file--For the purposes of this subchapter, a [ A] data file composed of event claims which have been altered by the deletion, encryption or other modification of data fields to protect patient and physician confidentiality and to satisfy other restrictions on the release of [ ~~ambulatory surgical care and emergency department~~ ] data imposed by statute.

(43) Race--A division of patients according to traits that are transmissible by descent and sufficient to characterize them as distinctly human types. Facilities [~~Reporting hospitals~~ ] shall report this data element according to the following racial types: American Indian, Eskimo, or Aleut; Asian or Pacific Islander; Black; White; or Other.

(44) Referring provider or referring other health professional--The physician or other health professional or facility that referred the patient for the principal procedure or event. For purposes of this definition, the term "provider" is not limited to only a physician, or facility as defined in paragraphs (27), (37) and (41) of this section. For purposes of this definition, the term "facility" means any health care facility entity, or office not just a hospital or ambulatory surgical center as defined in paragraph (27) of this section.

(45) Rendering provider or rendering other health professional--For the purposes of reporting on the modified ANSI 837 Professional Guide, the physician or other health professional who performed the surgical or radiological procedure on the patient for the event. In the case where a substitute provider (locum tenans) is used, that physician or other health professional shall be submitted as specified in this subchapter. For purposes of this definition, the term "provider" is not limited to only a physician, or facility as defined in paragraphs (27), (37) and (41) of this section.

[(44) Reporting hospital--A public, for-profit, or nonprofit institution licensed or owned by this state as a general or special hospital or a hospital owned by the state that volunteers to participate in the data collection, correction, certification and analysis process specified in this subchapter.]

(46) [~~(45)~~] Required minimum data set--The list of data elements for which facilities [~~reporting hospitals~~ ] may submit an event claim for each patient event occurring in the facility [~~hospital~~]. The required minimum data sets are [~~set is~~] specified in §421.67(d) and (e) [~~§1301.68(d)~~] of this title [~~(relating to Event Files--Records, Data Fields and Codes) and is only required if the hospital chooses to participate in reporting under this subchapter~~]. This list does not include all the data elements that are required by the modified ANSI 837 Institutional Guide or modified ANSI 837 Professional Guide to submit an acceptable event file. For example: Interchange Control Headers and Trailers, Functional Group Headers and Trailers, Transaction Set Headers and Trailers and Qualifying Codes (which identify or qualify subsequent data elements).

(47) [~~(46)~~] Research data file--A customized data file, which may include [~~includes~~] the data elements in the public use file and may include data elements other than the required minimum data set submitted to DSHS, except those data elements that could reasonably identify a patient or physician.

[(47) Scientific Review Panel--DSHS' appointees or agent who have experience and expertise in ethics, patient confidentiality, and health care data who review and approve or disapprove requests for data or information other than the public use data.]

(48) Submission--The transfer of a set of computer records as specified in §421.67 [~~§1301.68~~] of this title [~~(relating to Event Files--Records, Data Fields and Codes)~~] that constitutes the event file for one or more reporting hospitals under this subchapter.

(49) Submitter--The person or organization, which physically prepares an event file for one or more facilities [~~reporting hospitals~~ ] and submits them under this subchapter. A submitter may be a facility [~~hospital~~] or an agent designated by a facility [~~hospital~~] or its owner.

~~[(50) TDH--Texas Department of Health, or its successor agency, the Department of State Health Services.]~~

(50) [~~(51)~~] THCIC Identification Number--A string of 6 characters assigned by DSHS to identify facilities [~~hospitals~~ ] for reporting and tracking purposes. For a facility operating multiple facility locations under one license number and duplicating services at those locations, the department will assign a distinguishable identifier for each separate facility location under one license number. The relationship of the identifier to the name and license number of the facility is public information.

(51) [~~(52)~~ ] Uniform patient identifier--A unique identifier assigned by DSHS to an individual patient and composed of numeric, alpha, or alphanumeric characters, which remains constant across facilities [~~hospitals~~] and patient events. The relationship of the identifier to the patient-specific data elements used to assign it is confidential.

(52) [~~(53)~~] Uniform physician identifier--A unique identifier assigned by DSHS [~~theCouncil~~ ] to a physician or other health professional who is reported as referring, operating, rendering or other provider providing health care services [~~attending~~] or treating a patient in a facility [~~hospital~~] and which remains constant across facilities [~~hospitals~~]. The relationship of the identifier to the physician-specific data elements used to assign it is confidential. The uniform physician identifier shall consist of alphanumeric characters.

(53) [~~(54)~~] Validation--The process by which a provider verifies the accuracy and completeness of data and corrects any errors identified before certification.

§421.62.Collection of Hospital Outpatient and Ambulatory Surgical Center [~~Care and Emergency Department~~] Data.

(a)Each facility [~~Reporting hospitals~~] in operation for all or any of the reporting periods described in §421.63 [~~§1301.63~~ ] of this title (relating to Schedule for Filing Event Files) shall [~~may~~] submit toDSHS event claims as specified in §421.67 [~~§1301.68~~ ] of this title (relating to Event Files--Records, Data Fields and Codes) on all patient events in which the patient received one or more of the surgical procedures or radiological services covered by the revenue codes specified in §421.67(f) of this title [~~to DSHS~~]. All facilities that are exempt under the Health and Safety Code, §108.0025, but choose [~~If a hospital chooses~~] to participate in reporting under this subchapter, [~~the hospital~~] shall comply with the requirements in this subchapter. To the extent the medical screening examination, triage, observation, diagnosis or treatment is made by a health professional, other than a physician, data elements specified in §421.67(d)(29) - (34) or (e)(24) [~~§1301.68(d)(31)-(36)~~ ] of this title shall be filled accordingly or data elements in §421.67(d)(30) [~~§1301.68(d)(33)~~] or (33) [~~(36)~~] in the modified ANSI 837 Institutional Guide or §421.67(e)(25) in the modified ANSI 837 Professional Guide shall be marked with one of DSHS approved temporary "Physician" or "Other health professional" code numbers and data elements in §421.67(d)(29)(A) - (C) [~~§1301.68(d)(31)(A-C)~~] or (32)(A) - (C) [~~(34)(A-C)~~] in the ANSI 837 Institutional Guide format or §421.67(e)(24)(A) - (C) in the ANSI 837 Professional Guide format may be left blank.

(b) All patient events in which the patient received one or more of the surgical procedures or radiological services covered by the revenue codes specified in §421.67(f) of this title shall be reported by the facility that [~~reporting hospitals, for which the reporting hospital~~] prepares one or more bills for patient services. The facility [~~, the reporting hospital~~] shall submit an event claim corresponding to each bill containing the data elements required by §421.67 [~~§1301.68~~] of this title [ ~~(relating to Event Files - Records, Data Fields and Codes)~~ ]. For all patients who received one or more of the surgical procedures or radiological services covered by the revenue codes specified in §421.67(f) of this title for which the facility [~~hospital~~] does not prepare a bill for patient services, the facility [ ~~hospital~~] shall submit an event claim containing the required minimum data set.

(c) Each facility [~~All reporting hospitals~~ ] shall submit event files by electronic filing unless the facility [~~hospital~~ ] receives an exemption letter from DSHS.

(d) Each facility [~~All reporting hospitals~~ ] shall submit event claims and event files in the format specified in §421.67 [~~§1301.68~~] of this title [~~(relating to Event Files--Records, Data Fields and Codes)~~].

(e) Each facility [~~All reporting hospitals~~ ] shall submit event files, data certifications and other required information to DSHS or its agents at physical or telephonic addresses specified by DSHS. DSHS shall notify all facilities [ ~~reporting hospitals~~ ] and submitters in writing and by publication in the Texas Register at least 30 calendar days before any change in the addresses.

(f) Each facility [~~Reporting hospitals~~] may submit event files [~~themselves~~], or may designate an agent to submit the event files. If a facility [~~hospital~~ ] designates an agent, it shall inform DSHS of the designation in writing at least 30 calendar days prior to the agent's submission of any discharge report. The facility [~~reporting hospital~~] shall inform DSHS in writing at least 30 calendar days prior to changing agents or making the submissions itself.

§421.63.Schedule for Filing Event Files.

(a) For patient events [~~discharges~~] occurring on or after January 1, 2009 [~~2006~~], as specified by DSHS, facilities [~~reporting hospitals~~] shall file event files according to the following schedule as shown in paragraphs (1) - (4) of this subsection:

(1) - (4) (No change.)

(b) Extensions to processing due dates may be granted by DSHS in response to a written request signed by the facility's [~~reporting hospital's~~ ] chief executive officer. Requests must be in writing, must be received at least 5 working days prior to the due date and must be accompanied by adequate justification for the delay. A timely written request shall constitute a stay (delay) of the due date until a decision is issued by DSHS.

§421.64.Instructions for Filing Event Files.

(a) Electronic Data Interchange. Event files may be filed electronically [~~by modem~~] using electronic data interchange (EDI). All event files and event claims shall be reported using the same file and record formats specified in §421.67 [~~§1301.68~~ ] of this title (relating to Event Files--Records, Data Fields and Codes) regardless of the medium of transmission. DSHS shall document instructions for filing event files by EDI and shall make this documentation available to facilities [~~reporting hospitals~~ ] at no charge and to the public for the cost of reproduction. DSHS shall notify facilities [ ~~hospitals~~] reporting under this subchapter and their designated agents directly in writing at least 90 calendar days in advance of any change in instructions for filing event files by EDI. DSHS' instructions shall follow Department of Information Resources standards for EDI.

(b) File Transfer Protocol (FTP). Event files may be filed by FTP using a Transmission Control Protocol over Internet Protocol (TCP/IP) Network connection. DSHS shall document instructions for filing event files by FTP and shall make this documentation available to facilities [~~reporting hospitals~~] at no charge and to the public for the cost of reproduction or on DSHS' Internet website. DSHS shall notify facilities [~~hospitals~~] reporting under this subchapter and their designated agents directly in writing at least 90 calendar days in advance of any change in instructions for filing event files by FTP. DSHS' instructions shall follow Department of Information Resources standards for FTP.

(c) Other Electronic or Magnetic Media. An event report may be filed on other electronic or magnetic media with prior written approval by DSHS. All events shall be reported using the same file and record formats specified in §421.67 of this title regardless of medium. DSHS will not normally approve any medium, which the department or the DSHS contract vendor is not currently equipped to read at the time of the request for approval.

(1) Media specifications are:

(A) computer disk (CD): MS-DOS formatted; PC Text file (ASCII); or

(B) other electronic or magnetic media only with the prior written approval from the department.

(2) Facilities shall submit to DSHS only pre-approved media with the following external identification affixed:

(A) hospital name;

(B) facility identifier;

(D) number of records by record type; and

(E) the description: "OUTPATIENT DATA."

(3) In addition to the provisions of this section, DSHS shall document instructions for filing discharge reports on electronic or magnetic media and shall make this documentation available to facilities at no charge and to the public for the cost of reproduction. DSHS shall notify facilities or their designated agents directly in writing at least 90 calendar days in advance of any change in instructions for filing event reports on electronic or magnetic media.

§421.65.Acceptance of Event Files and Correction of Data Content Errors.

(a) Upon receipt of an event file, DSHS shall establish a process to determine if it satisfies minimum criteria for processing. If it does not, DSHS shall establish a process to provide a report to be returned to the submitter regarding the invalid event file in a format and media that is approved for that provider and states the deficiencies. The facility [~~reporting hospital~~] shall submit a corrected event file within 10 calendar days of notification by DSHS or DSHS' agent. An event file does not meet minimum standards for processing if the file structure does not conform to the specifications in §421.67 [~~§1301.68~~] of this title (relating to Event Files--Records, Data Fields and Codes).

(b) Correction of Data Content Errors.

(1) DSHS shall establish an audit process for all event files accepted for processing. DSHS shall notify the facility [~~reporting hospital~~ ] identified from the event file in detail of all errors detected in an event file which was received in an acceptable format as provided in §421.67 [~~§1301.68~~] of this title [~~(relating to Event Files - Records, Data Fields and Codes)~~].

(2) Within 30 calendar days of receiving initial notice of errors in an event file, the facility [~~reporting hospital~~] shall correct all event claims containing errors, add any event claims determined to be missing from the initial event file and resubmit the corrected and/or previously missing event claims. If the facility [~~reporting hospital~~] disagrees with any identified error, the facility [~~hospital~~] may indicate that the event [~~discharge~~] claim is as accurate as it can be or cannot be corrected. Each facility [~~reporting hospital~~ ] shall submit such modified and/or additional event claims as may be required to allow the chief executive officer or the chief executive officer's designated agent to certify the quarterly event file as required by §421.66 [~~§1301.66~~] of this title (relating to Certification of Compiled Event Data). Corrections to an [a] event file shall be submitted on approved media and formats as specified in §421.64 [ ~~§1301.64~~] of this title (relating to Instructions for Filing Event Files) and §421.67 [~~§1301.68~~] of this title [~~(relating to Event Files-Records, Data Fields and Codes)~~] unless DSHS approves another medium or format.

(3) Within 10 calendar days of receiving corrections to an event file from a facility [~~reporting hospital~~], DSHS shall notify the facility [~~reporting hospital~~] of any remaining errors. The facility [~~reporting hospital~~ ] shall have 10 calendar days from receipt of this notice to correct the errors noted or indicate why the data should be deemed acceptable and complete. This process may be repeated until the data is substantially accurate and the facility [~~reporting hospital~~] is able to certify the event file as required by §421.66 [~~§1301.66~~] of this title [ ~~(relating to Certification of Compiled Event Data)~~ ] or the deadline for submitting corrections prior to certification is reached. Corrected data is required to be submitted on or before the following dates for the respective quarter's discharges; Quarter 1 - August 1, Quarter 2 - November 1, Quarter 3 - February 1, Quarter 4 - May 1. DSHS may grant an extension to all facilities [~~hospitals with ambulatory surgical units or emergency departments~~] when deemed necessary.

(4) Event claims that have not been previously submitted shall be submitted prior to the deadline for the following quarter's data. Correction and certification of these previously missing or additional event claims for the prior calendar quarter shall be made according to the deadlines established for following quarter in which the data that is scheduled to be processed as specified in §421.63(a) [~~§1301.63(a)~~ ] of this title (relating to the Schedule for Filing Event Files), paragraph (3) of this subsection concerning the acceptance of event files and correction of data content errors), and §421.66(b) [~~§1301.66(b)~~] and (d) of this title [~~(relating to the Certification of Compiled Event Data)~~]. Corrections to event claims previously submitted or that have a statement [~~discharge~~] date prior to calendar quarter immediately before the calendar quarter being processed scheduled will not be processed.

(c) DSHS will document format acceptance criteria for event files. DSHS shall make this information available to submitters and facilities [~~reporting hospitals~~].

§421.66.Certification of Compiled Event Data.

(a) Within 5 months after the end of each reporting quarter, DSHS shall establish a process to compile one or more electronic data files for each facility [~~reporting hospital~~] using the event claims received from each facility [ ~~reporting hospital~~ ]. The certification file shall have one record for each patient event during the reporting quarter and one record for any patient event occurring during one prior reporting quarter for which additional event claims have been received. The data files, including reports returned to the facilities [~~reporting hospitals~~], allow [~~allows~~] the facility [~~reporting hospital~~ ] to provide physicians and other health professionals the opportunity to review, request correction of, and comment on patients for whom an [~~and~~ ] event occurred under the jurisdiction of the facilities [ ~~reporting hospitals~~] and they are indicated as "attending" or "operating or other". DSHS shall determine the format and medium in which the quarterly file will be delivered to facilities [~~reporting hospitals~~].

(b) The chief executive officer or chief executive officer's designated agent of each facility [~~reporting hospital~~] shall mark the appropriate box on the form provided indicating whether the facility [~~reporting hospital~~ ] is certifying or not certifying the event data and reports in the certification file specified in subsection (a) of this section. The chief executive officer or chief executive officer's designated agent shall sign and return the form to DSHS by fax or mail. A person designated by the chief executive officer and acting as the officer's agent may sign the certification form. Designation of an agent does not relieve the chief executive officer of personal responsibility for the certification. If the chief executive officer or chief executive officer's designated agent does not believe the quarterly file is accurate, the officer shall provide DSHS with detailed comments regarding the errors or submit a written request (on a form supplied by DSHS) and provide the data, processes and resources necessary to correct any inaccuracy and certify the certification file subject to those corrections being made prior to the deadlines specified in this subsection. Corrections to certification event data shall be submitted on or prior to the following schedule: Quarter 1 - October 15; Quarter 2 - January 15; Quarter 3 - April 15; Quarter 4 - July 15. Chief Executive Officers or designees that elect not to certify shall submit a reasoned justification explaining their decision to not certify their discharge encounter data and attach the justification to the certification form. Election to not certify data does not prevent certification file data from appearing in the public use data file. Data that is not corrected and submitted by the deadline may appear in the public use data file.

(1) policies and procedures are in place within the facility's [~~reporting hospital's~~ ] processes to validate and assure the accuracy of the event data and any corrections submitted; and

(2) all errors and omissions known to the facility [ ~~reporting hospital~~] have been corrected or the facility [ ~~reporting hospital~~] has submitted comments describing the errors and the reasons why they could not be corrected; and

(3) to the best of their knowledge and belief, the data submitted accurately represents the facility's [~~reporting hospital's~~ ] administrative status of [~~discharged~~] patients for which the services covered by the revenue codes identified in §421.67(f) of this title (relating to Event File--Records, Data Fields and Codes) were provided for the reporting quarter; and

(4) the facility [~~reporting hospital~~] has provided physicians and other health professionals a reasonable opportunity to review and comment on the event data of patients for which they were reported in one of the available physician number and name fields provided on the acceptable formats specified in §421.67 [~~§1301.68~~] of this title [ ~~(relating to Event Files--Records, Data Fields and Codes)~~ ] (for example, "attending physician" or "operating or other physician" as applicable ). The physicians or other health professionals may write comments and have errors brought to the attention of the chief executive officer or the chief executive officer's designated agent who [~~and~~ ] shall address any comments by the physicians or other health professionals; or

(5) if the chief executive officer or the officer's designee elects not to certify the event data file for a specific quarter, a written justification of any unresolved data issues concerning the accuracy and completeness of the data at the time of the certification shall be included on the certification form. Event claim data that has been audited, returned to the facility [~~reporting hospital~~] and is not certified, may be released and published in the public use data file and used by DSHS for analysis.

(d) Each facility [~~reporting hospital~~] shall submit its certification form for each quarter's data to DSHS by the first day of the ninth month (Quarter 1 - December 1; Quarter 2 - March 1; Quarter 3 - June 1; Quarter 4 - September 1) following the last day of the reporting quarter as specified in §421.63(a)(1)- (4) [~~§1301.63(a)(1)-(4)~~ ] of this title (relating to Schedule for Filing Event Files). DSHS may extend the deadline for any or all facilities [~~reporting hospitals~~] when deemed necessary.

(e) Facilities [~~Reporting hospitals~~], physicians or other health professionals may submit concise written comments regarding any data submitted by the associated facilities [~~reporting hospitals~~] or relating to services[ ,] they have delivered which may be released as public use data. Comments shall be submitted to DSHS on or before the dates specified in subsection (d) of this section, regarding the submission of the certification form. Commenters are responsible for assuring that the comments contain no patient or physician identifying information. Comments shall be submitted electronically using the method described in §421.64(a) [~~§1301.64(a)~~ ] and (b) of this title (relating to Instructions for Filing Event Files).

(f) (No change.)

§421.67.Event Files--Records, Data Fields and Codes.

(a) Facilities [~~Reporting Hospitals~~] shall submit event files, electronically in the file format for outpatient [~~hospital~~] bills defined by the American National Standards Institute (ANSI), commonly known as the ANSI ASC X12N form 837 Health Care Claims transaction for institutional claims or ANSI ASC X12N form 837 Health Care Claims transaction for professional claims .ANSI updates these formats [~~this format~~] from time to time by issuing new versions and the United States Department of Health and Human Services adopts regulations regarding HIPAA that update the version allowed for claim submissions.

(b) (No change.)

(c) In addition to the data elements contained in the ANSI 837 Institutional Guide and the ANSI 837 Professional Guide, DSHS has specified the location where each of the following data elements in this subsection shall be reported in the ANSI 837 Institutional [~~format~~] Guide format and the ANSI 837 Professional Guide format. Data element content, format and locations may change as state legislative requirements , or federal legislative or regulation requirements change [~~changes~~] (i.e., HIPAA).

(1) Patient race - This data element shall be reported at Loop 2010BA or 2010CA in the segment DMG05 as a numeric value. Acceptable codes are 1 = American Indian/Eskimo/ Aleut, 2 = Asian or, Pacific Islander, 3 = Black, 4 = White and 5 = Other Race. In order to obtain this data, the facility [~~hospital~~] staff retrieves the patient's response from a written form or asks the patient, or the person speaking for the patient to classify the patient. If the patient, or person speaking for the patient, declines to answer, the facility [~~hospital~~] staff is to use its best judgment to make the correct classification based on available data.

(2) Patient ethnicity - This data element shall be reported at Loop 2300 in the segment NTE02 as a numeric value. Acceptable codes are 1 = Hispanic or Latino Origin and 2 = Not of Hispanic or Latino Origin. In order to obtain this data, the facility [~~hospital~~ ] staff retrieves the patient's response from a written form or asks the patient, or the person speaking for the patient to classify the patient. If the patient, or person speaking for the patient, declines to answer, the facility [~~hospital~~] staff is to use its best judgment to make the correct classification based on available data.

(3) Other E-codes - These additional E-codes (maximum of 9 other E-codes, a total of 10 E-codes may be submitted) shall be reported (if applicable) in the following ANSI [~~X12N Form~~] 837 Institutional Guide locations: Loop 2300, segments, HI05-2, HI06-2, HI07-2, HI08-2, HI09-2, HI10-2, HI11-2 and HI12-2. (The first E-code is generally reported in Loop 2300 segment HI04-2). E-codes may be submitted in the ANSI 837 Professional Guide in the following locations Loop 2300, data fields: HI02-2, HI03-2, HI04-2, HI05-2, HI06-2, HI07-2 or HI08-2 if applicable preceded by "BN" qualifying code in the respective data field HI02-1, HI03-1, HI04-1, HI05-1, HI06-1, HI07-1 or HI08-1.

(4) THCIC Identification Number - This data element shall be submitted in data segment REF02 (Secondary Identification Number) of one of the following [~~followings~~] Loops where the patient received the event services:

(A) - (B) (No change.)

(C) Loop 2310E (ANSI 837 Institutional Guide) or Loop 2310D (ANSI 837 Professional Guide) associated with the "Service Facility Provider".

(d) Facilities [~~Reporting hospitals~~] shall submit the required minimum data set in the following modified ANSI 837 Institutional Guide format for all patients that are uninsured or considered self-pay or covered by third party payers in which the payer requires the claim be submitted in an ANSI 837 Institutional Guide format or CMS-1450 format for which an event claim is required by this subchapter. The required minimum data set for the modified (as specified in subsection (c) of this section) ANSI 837 Institutional Guide format includes the following data elements as listed in this subsection:

(1) - (12) (No change.)

(13) Type of Bill (Facility Type Code plus Claim Frequency Code);

(14) (No change.)

~~[(15) Start of Care:]~~

~~[(A) Start of Care Date; and]~~

~~[(B) Start of Care Hour;]~~

~~[(16) Patient (Discharge) Status;]~~

~~[(17) Patient Discharge Hour;]~~

(15) [~~(18)~~] Principal Diagnosis;

(16) [~~(19)~~] Patient's Reason for Visit;

(17) [~~(20)~~] External Cause of Injury (E-Code) up to 10 occurrences (if applicable);

(18) [~~(21)~~] Other Diagnosis Codes - up to 24 occurrences (all applicable);

(19) [~~(22)~~] Principal Procedure Code (if applicable);

(20) [~~(23)~~] Principal Procedure Date (if applicable);

(21) [~~(24)~~] Other Procedure Codes - up to 24 occurrences (if applicable);

(22) [~~(25)~~] Other Procedure Dates - up to 24 occurrences (if applicable);

(23) [~~(26)~~] Occurrence Code - up to 24 occurrences (if applicable);

(24) [~~(27)~~] Occurrence Code Associated Date - up to 24 occurrences (if applicable);

(25) [~~(28)~~] Value Code - up to 24 occurrences (if applicable);

(26) [~~(29)~~] Value Code Associated Amount - up to 24 occurrences (if applicable);

(27) [~~(30)~~] Condition Code - up to 24 occurrences (if applicable);

(28) Related Cause Code - up to 3 occurrences (if applicable);

(29) [~~(31)~~] Other Provider [ ~~Attending Physician~~] or Other Health Professional [ ~~Attending Practitioner~~] Name:

(A) Other Provider or Other Health Professional [ ~~Attending Practitioner~~] Last Name;

(B) Other Provider or Other Health Professional [ ~~Attending Practitioner~~] First Name; and

(30) [~~(32)~~] Other Provider or Other Health Professional [~~Attending Practitioner~~] Primary Identifier (National Provider Identifier [~~, when HIPAA rule is implemented~~]);

(31) [~~(33)~~] Other Provider or Other Health Professional [~~Attending Practitioner~~] Secondary Identifier (Texas state license number [~~or UPIN~~]);

(32) [~~(34)~~] Operating Physician or Other Health Professional [~~Practitioner~~] Name [~~(if applicable)~~]:

(A) Operating Physician or Other Health Professional [ ~~Practitioner~~] Last Name;

(B) Operating Physician or Other Health Professional [ ~~Practitioner~~] First Name; and

(33) [~~(35)~~] Operating Physician or Other Health Professional [~~Practitioner~~] Primary Identifier (National Provider Identifier[~~, when HIPAA rule is implemented~~]);

(34) [~~(36)~~] Operating Physician or Other Health Professional [~~Practitioner~~] Secondary Identifier (Texas state license number [~~or UPIN~~]);

(35) [~~(37)~~] Total Claim Charges;

(36) [~~(38)~~] Revenue Service Line Details (up to 999 service lines) (all applicable);

(A) Revenue Code;

(B) Procedure Code;

(D) HCPCS [~~HCPCS/HIPPS~~] Procedure Modifier 2;

(E) HCPCS [~~HCPCS/HIPPS~~] Procedure Modifier 3;

(F) HCPCS [~~HCPCS/HIPPS~~] Procedure Modifier 4;

(G) Charge Amount;

(H) Unit Code;

(I) Unit Quantity;

(J) Unit Rate; and

(K) Non-covered Charge Amount.

(37) [~~(39)~~] Service Provider Name;

(38) [~~(40)~~] Service Provider Primary Identifier - Provider Federal Tax ID (EIN) or National Provider Identifier [~~(when HIPAA rule is implemented)~~];

(39) [~~(41)~~] Service Provider Address:

(A) Service Provider Address Line 1;

(B) Service Provider Address Line 2 (if applicable);

(D) Service Provider State; and

(E) Service Provider ZIP; and

(40) [~~(42)~~] Service Provider Secondary Identifier - THCIC 6-digit facility [~~Hospital~~] ID assigned to each facility;[.]

(41) Referring Provider or Referring Other Health Professional Name (if applicable) (Up to 2 Occurrences):

(A) Referring Provider or Referring Other Health Professional Last Name;

(B) Referring Provider or Referring Other Health Professional First Name;

(42) Referring Provider or Referring Other Health Professional Primary Identifier (National Provider Identifier) (if applicable) (Up to 2 Occurrences); and

(43) Referring Provider or Referring Other Health Professional Secondary Identifier (Texas state license number) (if primary identifier not available) (if applicable) (Up to 2 Occurrences).

(e) Facilities shall submit the following required minimum data set in the following modified ANSI 837 Professional Guide format for all patients for which an event claim is required by a third party payer to be in the ANSI 837 Professional Guide format or CMS-1500 format and required to be submitted under this subchapter. At a facility's option, a facility may choose to submit the required data set listed in subsection (d) of this section. The required minimum data set for the modified (as specified in subsection (c) of this section) ANSI 837 Professional Guide format includes the following data elements as listed in this subsection.

(1) Patient Name.

(A) Patient Last Name;

(B) Patient First Name; and

(2) Patient Address.

(A) Patient Address Line 1;

(B) Patient Address Line 2 (if applicable);

(D) Patient State;

(E) Patient ZIP; and

(F) Patient Country (if address is not in United States of America or one of its territories);

(3) Patient Birth Date;

(4) Patient Sex;

(5) Patient Race;

(6) Patient Ethnicity;

(7) Patient Social Security Number;

(8) Patient Account Number;

(9) Patient Medical Record Number (if applicable);

(10) Claim Filing Indicator Code (Payer Source - primary and secondary (if applicable for secondary payer source);

(11) Payer Name - Primary and secondary (if applicable, for both);

(12) National Plan Identifier - for primary and secondary (if applicable) payers (National Health Plan Identification number, if applicable and when assigned by the federal government);

(13) Type of Bill (Facility Type Code plus Claim Frequency Code);

(14) Service Date;

(15) Principal Diagnosis;

(16) Other Diagnosis Codes - up to 7 occurrences (all applicable);

(17) Related Cause Code - up to 3 occurrences (if applicable);

(18) Principal Procedure Code (if applicable);

(19) Principal Procedure Date (if applicable);

(20) Procedure Codes - up to 50 occurrences (all applicable):

(A) HCPCS Procedure Modifier 1;

(B) HCPCS Procedure Modifier 2;

(D) HCPCS Procedure Modifier 4;

(E) Charge Amount;

(F) Unit Code; and

(G) Unit Quantity;

(21) Referring Provider or Referring Other Health Professional Name (if applicable) (Up to 2 occurrences):

(A) Referring Provider or Referring Other Health Professional Last Name;

(B) Referring Provider or Referring Other Health Professional First Name; and

(22) Referring Provider or Referring Other Health Professional Primary Identifier (National Provider Identifier) (if applicable) (Up to 2 occurrences);

(23) Referring Provider or Referring Other Health Professional Secondary Identifier (Texas state license number) (if primary identifier not available) (if applicable) (Up to 2 occurrences);

(24) Rendering Provider or Rendering Other Health Professional Name (Up to 2 occurrences):

(A) Rendering Provider or Rendering Other Health Professional Last Name;

(B) Rendering Provider or Rendering Other Health Professional First Name; and

(25) Rendering Provider or Rendering Other Health Professional Primary Identifier (National Provider Identifier) (Up to 2 occurrences);

(26) Rendering Provider or Rendering Other Health Professional Secondary Identifier (Texas state license number) (if primary identifier not available) (Up to 2 occurrences);

(27) Total Claim Charges;

(28) Service Provider Name;

(29) Service Provider Primary Identifier--Provider Federal Tax ID (EIN) or National Provider Identifier;

(30) Service Provider Address:

(A) Service Provider Address Line 1;

(B) Service Provider Address Line 2 (if applicable);

(D) Service Provider State; and

(E) Service Provider ZIP;

(31) Service Provider Secondary Identifier--THCIC 6-digit Hospital ID assigned to each facility.

(f) Facilities shall submit the required minimum data set to DSHS for each patient who has one or more of the following revenue codes for services rendered to the patient in the facility.

(1) 0321 Radiology--Diagnostic Angiocardiology;

(2) 0322 Radiology--Diagnostic Arthrography;

(3) 0323 Radiology--Diagnostic Arteriography;

(4) 0329 Radiology--Diagnostic Other Radiology - Diagnostic;

(5) 0330 Radiology--Therapeutic General Classification;

(6) 0333 Radiology--Therapeutic Radiation Therapy;

(7) 0339 Radiology--Therapeutic Other Radiology - Therapeutic;

(8) 0340 Nuclear Medicine General Classification;

(9) 0341 Nuclear Medicine Diagnostic;

(10) 0342 Nuclear Medicine Therapeutic;

(11) 0343 Nuclear Medicine Diagnostic Pharmaceuticals;

(12) 0344 Nuclear Medicine Therapeutic Pharmaceuticals;

(13) 0349 Nuclear Medicine Other Nuclear Medicine;

(14) 0350 Computed Tomography (CT) Scan General Classification;

(15) 0351 Computed Tomography (CT)--Head Scan;

(16) 0352 Computed Tomography (CT)--Body Scan;

(17) 0359 Computed Tomography (CT)--Other;

(18) 0360 Operating Room Services General Classification;

(19) 0361 Operating Room Services Minor Surgery;

(20) 0369 Operating Room Services Other Operating Room Services;

(21) 0400 Other Imaging Services General Classification;

(22) 0401 Other Imaging Services Diagnostic Mammography;

(23) 0403 Other Imaging Services Screening Mammography;

(24) 0404 Other Imaging Services Positron Emission Tomography (PET);

(25) 0409 Other Imaging Services Other Imaging Services;

(26) 0481 Cardiology Cardiac Catheterization Lab;

(27) 0483 Cardiology Echocardiology;

(28) 0489 Cardiology Other Cardiology Services;

(29) 0490 Ambulatory Surgical Care General Classification;

(30) 0499 Ambulatory Surgical Care Other Ambulatory Surgical;

(31) 0500 Outpatient Services General Classification;

(32) 0509 Outpatient Services Other Outpatient;

(33) 0610 Magnetic Resonance Technology General Classification;

(34) 0611 Magnetic Resonance Technology Magnetic Resonance Imaging (MRI)--Brain/Brainstem;

(35) 0612 Magnetic Resonance Technology Magnetic Resonance Imaging (MRI)--Spinal Cord/Spine;

(36) 0614 Magnetic Resonance Technology Magnetic Resonance Imaging (MRI)--Other;

(37) 0615 Magnetic Resonance Technology Magnetic Resonance Angiography (MRA)--Head and Neck;

(38) 0616 Magnetic Resonance Technology Magnetic Resonance Angiography (MRA)--Lower Extremities;

(39) 0618 Magnetic Resonance Technology Magnetic Resonance Angiography (MRA)--Other;

(40) 0619 Magnetic Resonance Technology Other Magnetic Resonance Technology;

(41) 0760 Specialty Room--Treatment/Observation Room General Classification;

(42) 0761 Specialty Room--Treatment Room;

(43) 0762 Specialty Room--Observation Room; and

(44) 0769 Specialty Room--Other Specialty Room.

§421.68.Event Data Release.

(a) DSHS records are public records under Government Code, Chapter 552, except as specifically exempted by Health and Safety Code, §§108.010, 108.011 and 108.013 or other state or federal law. Copies of such records may be obtained upon request and upon payment of user fees established by DSHS. The public use data file shall be available for public inspection during normal business hours. Event claims in the original format as submitted to DSHS are not available to the public, are not stored at DSHS and are exempt from disclosure pursuant to Health and Safety Code, §§108.010, 108.011 and 108.013, and shall not be released. Likewise, patient and physician identifying data collected by the DSHS through editing of facility data shall not be released.

(b) Creation of codes and identifiers. DSHS shall develop the following codes and identifiers, as listed in paragraphs (1) - (2) of this subsection, required for creation of the public use data file and for other purposes.

(1) DSHS shall create a process for assigning uniform patient identifiers, uniform physician identifiers and uniform other health professional identifiers using data elements collected. This process is confidential and not subject to public disclosure. Any documents or records produced describing the process or disclosing the person associated with an identifier are confidential and not subject to public disclosure.

(2) DSHS shall create a process for assigning geographic identifiers to each event record.

(c) Requests for outpatient event data files including data on one or more providers are matters of public record and copies of all requests shall be maintained by DSHS in accordance with DSHS records retention schedule.

(d) All users including Texas state agencies that request outpatient event data shall abide by the data use agreement.

(e) DSHS shall establish procedures for screening all requests to assure that filling the request will not violate the confidentiality provisions of Health and Safety Code, Chapter 108.

(f) The data elements specified for outpatient event reports in this section do not constitute "Provider Quality Data" as discussed in Health and Safety Code, §108.010.

(g) Creation of public use data file. DSHS will create a public use data file by creating a single record for each reportable outpatient event and adding, modifying or deleting data elements in the following manner as listed in this subsection:

(1) delete patient and insured name, Social Security number, address and certificate data elements, any patient identifying information, and patient control and medical record numbers;

(2) convert patient birth date to age;

(3) convert procedure dates to a code for the day of the week;

(4) convert occurrence dates to day values;

(5) delete physician and other health professional names and numbers and assign a alphanumeric uniform physician identifier for the physicians and other health professionals who were reported as "referring," "rendering," "operating or other" or "other provider" on patients;

(6) assign codes indicating the primary and secondary sources of payment;

(7) the minimum cell size required by Health and Safety Code, §108.011(i)(2), shall be five, unless DSHS determines that a higher cell size is required to protect the confidentiality of an individual patient or physician;

(8) convert all procedure codes to HCPCS codes (in the version that is current for the date the data was due to be submitted or the version in effect at the date of service);

(9) add nationally accepted risk and severity adjustment scores utilizing an algorithm approved by DSHS, when available and applicable;

(10) data elements to be included in the public use data file:

(A) Event Year and Quarter;

(B) Provider Name (Facility Name);

(D) Facility Type Indicators;

(E) Patient Sex/Gender;

(F) Patient ZIP Code;

(G) County Code;

(H) Health Service Region Code;

(I) Patient State;

(J) Patient Race;

(K) Patient Ethnicity;

(L) Claim Type Indicator;

(M) Type of Bill;

(N) Principal Diagnosis Code (Current version of ICD codes at the time data is submitted);

(O) Other Diagnosis Codes (Up to 24 diagnosis codes can be submitted and reported. Current version of ICD codes at the time data is submitted);

(P) Principal Procedure code (if applicable) (Current version of HCPCS codes at the time data is submitted);

(Q) Other Procedure codes (Up to 24 procedure codes can be submitted and reported. Current version of HCPCS codes at the time data is submitted);

(R) Reason For Visit (Current version of ICD or HCPCS codes at the time data is submitted);

(S) External Cause of Injury (E-codes), (if applicable) (Current version of ICD codes at the time data is submitted. Up to nine (9) E-codes can be submitted and reported);

(T) Related Cause Code, (if applicable) (Up to three (3) codes can be submitted and reported);

(U) Day of Week Patient is provided services code (Sunday = 1, Monday = 2, Tuesday = 3, Wednesday = 4, Thursday = 5, Friday = 6, Saturday = 7);

(V) Age group of patient;

(W) CRG Code (and associated codes if applicable);

(X) APG Code (Obtained from 3M APG Grouper) if applicable (Up to 10);

(Y) APG Category Code (Obtained from 3M APG Grouper) if applicable (Up to 10);

(Z) APG Type Code (Obtained from 3M APG Grouper) if applicable (Up to 10);

(AA) Final APG Assignment Code (Obtained from 3M APG Grouper) if applicable (Up to 10);

(BB) Final APG Category Code (Obtained from 3M APG Grouper) if applicable (Up to 10);

(CC) APC Procedure Code (if applicable) (Up to 10);

(DD) APC Procedure Status Indicator Code (if applicable) (Up to 10);

(EE) APC Diagnosis Edits (if applicable) (Up to 10);

(FF) APC Procedure Code Edits (if applicable) (Up to 10);

(GG) APC Weight (if applicable) (Up to 10);

(HH) APC Base Procedure (if applicable) (Up to 10);

(II) Clinical Classification Software Category Codes and associated codes, if applicable;

(JJ) Uniform Physician Identifier assigned to Rendering Physician or Rendering Other Health Professional;

(KK) Uniform Physician Identifier assigned to Operating Physician or Other Physician or Other Health Professional;

(LL) Uniform Physician Identifier assigned to Other Provider or Other Health Professional;

(MM) Uniform Physician Identifier assigned to Referring Provider or Referring Other Health Professional;

(NN) Ancillary Service--Other Charges;

(OO) Ancillary Service--Pharmacy Charges;

(PP) Ancillary Service--Medical/Surgical Supply Charges;

(QQ) Ancillary Service--Durable Medical Equipment Charges;

(RR) Ancillary Service--Used Durable Medical Equipment Charges;

(SS) Ancillary Service--Physical Therapy Charges;

(TT) Ancillary Service--Occupational Therapy Charges;

(UU) Ancillary Service--Speech Pathology Charges;

(VV) Ancillary Service--Inhalation Therapy Charges;

(WW) Ancillary Service--Blood Charges;

(XX) Ancillary Service--Blood Administration Charges;

(YY) Ancillary Service--Operating Room Charges;

(ZZ) Ancillary Service--Lithotripsy Charges;

(AAA) Ancillary Service--Cardiology Charges;

(BBB) Ancillary Service--Anesthesia Charges;

(CCC) Ancillary Service--Laboratory Charges;

(DDD) Ancillary Service--Radiology Charges;

(EEE) Ancillary Service--MRI Charges;

(FFF) Ancillary Service--Outpatient Services Charges;

(GGG) Ancillary Service--Emergency Service Charges;

(HHH) Ancillary Service--Ambulance Charges;

(III) Ancillary Service--Professional Fees Charges;

(JJJ) Ancillary Service--Organ Acquisition Charges;

(KKK) Ancillary Service--ESRD Revenue Setting Charges;

(LLL) Ancillary Service--Clinic Visit Charges;

(MMM) Total Charges--Ancillary;

(NNN) Total Non-Covered Ancillary Charges;

(OOO) Total Charges;

(PPP) Total Non-Covered Charges;

(QQQ) Encounter Identifier--a unique number for each encounter for the quarter;

(RRR) Service Line Revenue Code;

(SSS) Service Line Procedure Code;

(TTT) HCPCS/HIPPS Procedure Code;

(UUU) HCPCS/HIPPS Procedure Modifiers (Up to 4 may be submitted and reported);

(VVV) Service Line Charge Amount;

(WWW) Service Line Unit Code;

(XXX) Service Line Unit Count;

(YYY) Service Line Non-Covered Charge Amount; and

(ZZZ) Patient Country (when the address is not in United States of America and confidentiality can be maintained).

(h) Release of public use data files. DSHS shall release in an aggregate form, without uniform patient, physician or other health professional identifiers, public use data relating to facilities described by the Health and Safety Code, §108.0025(1), that are not rural providers because they do not meet the requirements of Health and Safety Code, §108.0025(2).

(1) DSHS will make available a public use data file on electronic, magnetic or optical media for each quarter.

(2) DSHS shall release public use data from facilities that have certified the data as required by §421.66 of this title (relating to Certification of Compiled Event Data). A facility's failure to execute the certification form by the dates specified in §421.66(d) of this title, or election to not certify the discharge encounter data shall not prevent the DSHS from releasing the facility's data if DSHS believes the data submitted is reasonably accurate and complete. DSHS may suppress for any quarter's data one or more data elements if deemed necessary to comply with provisions of the statute.

(3) If additional event claims (not previously submitted as specified in §421.65(b)(4) of this title (Acceptance of Event Files and Correction of Data Content Errors), excluding replacement, adjustments and void/cancel claims become available after the initial release of the public use data file for any quarter, DSHS will add the discharge claims, that are received on or prior to the dates specified in §421.63(a)(1) - (4) of this title (relating to Schedule for Filing Event Files) of the following quarter, to the public use data file and make the additional records available to the public.

(4) A public use data file which is disseminated to a requestor shall not be considered a report issued by DSHS as referenced in Health and Safety Code, §108.011(f), and requires no additional opportunity for the facility to review or comment on the data.

(5) With any public use data file prepared by the DSHS, DSHS shall attach all comments submitted by providers, which relate to any data included in the file. DSHS shall also make these comments available at DSHS offices and on the DSHS Internet site.

(i) A outpatient event research data file may be released provided the following criteria are met:

(1) the DSHS Outpatient Data Research Data File Request Form is completed and submitted to DSHS;

(2) the requestor has made payment according to DSHS' fee schedule;

(3) the Institutional Review Board reviews the research request and has determined the proposed research outcome can be achieved with the requested data;

(4) the Institutional Review Board grants authorization to the request or restricts access to specified data elements determined to be inappropriate for the research proposal in accordance with §421.10 of this title (relating to Institutional Review Board);

(5) the requestor agrees to dispose of the research data using authorized methods by the established end date stated on the written data use agreement; and

(6) the requestor has signed a written data use agreement.

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

Filed with the Office of the Secretary of State on June 2, 2008.

TRD-200802829

Lisa Hernandez

General Counsel

Department of State Health Services

Earliest possible date of adoption: July 13, 2008

For further information, please call: (512) 458-7111 x6972