TITLE 25.HEALTH SERVICES

Part 16. TEXAS HEALTH CARE INFORMATION COUNCIL

Chapter 1301. HEALTH CARE INFORMATION

Subchapter E. COLLECTION AND RELEASE OF AMBULATORY SURGICAL CARE AND EMERGENCY DEPARTMENT DATA ON REPORTING HOSPITALS

25 TAC §§1301.61 - 1301.69

The Texas Health Care Information Council (Council) proposes new §§1301.61 - 1301.69, concerning the collection and release of Ambulatory Surgical Care and Emergency Department Data on reporting hospitals. The new rules are proposed under §§108.006(a)(1), (3), (7), and 108.009(a), (b), (h), Health and Safety Code, which authorize the Council to collect hospital ambulatory care data and hospital emergency department data. Submission of the data will be voluntary, not required. The sections are proposed to enhance the statewide health care data collection system established by the Council and provide additional information to the legislature, governor and public regarding the quality and effectiveness of health care and access to health care by the citizens of Texas.

Mike Gilliam, Jr., MSW, MPH Director, Texas Department of Health, Center for Health Statistics, (which provides all administrative support to the Council), has determined that for the first five-year period the new rules are in effect there will be approximately $859,000 in additional costs to the state.

The $858,000 figure was determined as follows: Developmental costs of $237,000, including additional staff and contractual costs for additional data collection, auditing, and modifications to existing software applications, will be expended in the first two years. In years three through five the state will expend approximately $207,000 annually in payments to the entity that currently receives inpatient data for the Council's Health Care Data Collection System. The costs are associated with the projected costs of staff time for data cleansing, analysis for file (public use data, research data, or open records requests) and report release. The staff time includes the time and resources necessary to retrieve, review and post comments on the files and Internet as required by Chapter 108, Health and Safety Code, as a result of the proposed rules.

The total cost of the project is $2,272,000 and the state if awarded the Health Information Technology contract (AHRQ Solicitation #04-0015) through the United States Department of Health and Human Services, Agency for Healthcare Research and Quality (AHRQ) competitive process could anticipate receiving federal monies in the amount of $1,413,000 from AHRQ. The estimates are derived from the contract bid submitted to AHRQ.

Mr. Gilliam has determined that for the first five-year period the new rules are in effect there will be between $6,823 and $14,230 in costs to local governments for each hospital owned and participating in this data collection and reporting effort (cost breakdowns are provided in the section below in the impact statement to providers). There is $5,053 to $9,952 per hospital in fiscal implications relating to administrative costs of the local governments as a result of §§1301.61-1301.69, because local governments are affected if they own a hospital that participates in this data collection program.

Mr. Gilliam has determined that for the first five-year period the new rules are in effect there will be between $6,823 and $14,230 in costs to small businesses for each hospital owned and participating in this data collection and reporting effort (cost breakdowns are provided in the section below in the impact statement to providers). A comparison of the cost for small businesses with the cost of compliance for the largest business affected by the rule indicates that the cost for each hour of labor for small business is between $35.41 and $42.78 (Computer Programmers wages, Occupational Wages for All Industries: State of Texas; Data Collected May-November 2003, Source: Occupational Employment Statistics Program, Labor Market Information, Texas Workforce Commission) and the cost per hour of labor for the largest business is $35.41 and $42.78 (Occupational Wages for All Industries: State of Texas; Data Collected May-November 2003, Source: Occupational Employment Statistics Program, Labor Market Information, Texas Workforce Commission). The one time programming costs would be the hourly wages times and estimated 50 - 100 hours of programming time giving a range of $1,171 to $4,278. A comparison of the cost for small businesses with the cost of compliance for the largest business affected by the rule indicates that the cost for each hour of labor for the first year of the five years for small business is between $30.48 and $36.02 (Medical and Health Services Mangers, Occupational Wages for All Industries: State of Texas; Data Collected May-November 2003, Source: Occupational Employment Statistics Program, Labor Market Information, Texas Workforce Commission) and the cost per hour of labor for the largest business is $30.48 and $36.02 (Medical and Health Services Mangers, Occupational Wages for All Industries: State of Texas; Data Collected May-November 2003, Source: Occupational Employment Statistics Program, Labor Market Information, Texas Workforce Commission). The annual costs would be the hourly wages times the estimated 30 to 50 hours per year for administrative work for submitting, correcting and certifying the data ranges between $5,053 and $9,952 per hospital. The annual costs estimate a 5% increase in the hourly wages each year.

Mr. Gilliam has determined that for the first five-year period the new rules are in effect there will be between $6,823 and $14,230 for each hospital owned and participating in this data collection and reporting effort in costs to each of the providers. There is $5,053 and $9,952 per hospital in fiscal implications relating to administrative costs of the providers as a result of §§1301.61- 1301.69, because the providers would need to modify their computer records systems identify and submit the ambulatory surgical care and emergency department data to the Council. Texas Hospital Association (THA) provided an estimate range of costs for each hospital participating of $8,000 - $22,000 based on 50-100 hours programming times $160 - $220 per hour of programming time for computer programmer. The THA programmer wages are significantly higher than the states experience computer programmer hourly wage average ("Occupational Wages for All Industries: State of Texas; Data Collected May-November 2003", Source: Occupational Employment Statistics Program, Labor Market Information, Texas Workforce Commission) for an experience programmer ($42.78 per hour), which would provide an estimate range of cost of $2,139 - $4,278. The THA estimate also assumes that the hospitals would be creating or building a separate data extract file for submission to the Council. The Council's estimates are based on the belief that reporting hospitals are able to submit a Health Insurance Portability and Accountability Act of 1996 (HIPAA) compliant billing claim file and the only modifications needed would be to modify the reporting hospitals current process to create and submit a HIPAA compatible claim file that includes the addition of Race and Ethnic background for each patient and potentially up to 9 additional external cause of injury codes (E-codes). The submission of additional E-codes in the ANSI Institutional Guide format only requires submitting the additional data elements with the proper qualifying code in the Health Information (HI) data segments. Section 2001.024(a)(4)(A) and 2001.024(a)(5)(B), Government Code, requires that the fiscal note estimate additional costs associated with implementing the proposed amendments and the probable economic cost to persons required to comply with the rule. The fiscal note is not required to anticipate costs for providing optional features based on the amendments, such as building a separate data extract system to submit data to the Council.

The Council's estimates for the first year costs for each reporting hospital to range from $2,685 - $6,079 with annual costs (second year - $960-$1,891; third year - $1,008 - $1,986; fourth year - $1,059 - $2,085; fifth year - $1,111 - $2,189) associated with the submission, correction and certification of the ambulatory surgical care and emergency department data (The costs were based on the average hourly wage and the experienced average hourly wage of Medical and Health Services mangers for 2003 and a 5% increase in the hourly wage each year. ("Occupational Wages for All Industries: State of Texas; Data Collected May-November 2003", Source: Occupational Employment Statistics Program, Labor Market Information, Texas Workforce Commission).

Mr. Gilliam has determined for each year of the first five-year period the proposed sections are in effect, the anticipated public benefit will be greater ease in identifying under educated and underserved areas. The new data will provide information regarding the access to care for the citizens of Texas and assist in identifying populations at risk. The data will provide information to the Texas Department of Health (TDH) and the Department of State Health Services (DSHS) regarding areas and subjects requiring additional health education or assistance.

Mr. Gilliam has determined for each year of the first five-year period the proposed sections are in effect, there is no anticipated impact to local employment.

Comments on the proposed rules may be submitted to Bruce M. Burns, D.C., Program Specialist, Texas Department of Health, Center for Health Statistics, 1100 West 49th Street, Room M-660 Austin, Texas 78751. Comments must arrive no later than 30 calendar days after the date that these proposed sections are published in the Texas Register .

The Council will entertain requests for a public hearing until the 25th day after the date the rules are published in the Texas Register .

The new sections are proposed under the Health and Safety Code, §108.006 and §108.009. The Council interprets §108.006 as authorizing it to adopt rules necessary to carry out Chapter 108, including rules concerning data collection requirements. The Council interprets §108.009 as authorizing the Council to adopt rules regarding the collection of data from hospitals in uniform submission formats in order for the incoming data to be substantially valid, consistent, compatible and manageable.

The Health and Safety Code, §§108.002, 108.006, 108.009, 108.010 and 108.011, are affected by the new sections.

§1301.61.Definitions.

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

(1) Accurate and Consistent Data--Data that has been edited by DSHS and subjected to provider validation and certification.

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

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

(4) APC--Ambulatory Payment Classification.

(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.

(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.

(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 submitted for each 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.

(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 §1301.66 of this title (relating to Certification of Event Data).

(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.

(10) Clinical Classification Software--A classification systems that groups ICD-9-CM diagnoses and procedures into a limited number of clinically meaningful categories.

(11) Comments--The notes or explanations submitted by the 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.

(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.

(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) EDI--Electronic Data Interchange--A method of sending data electronically from one computer to another. EDI helps providers and payers maintain a flow of vital information by enabling the transmission of claims and managed care transactions.

(19) Electronic Filing--The submission of computer records in machine readable form by modem transfer from one computer to another (EDI) or by recording the records on a nine track magnetic tape, computer diskette or other magnetic media acceptable to DSHS.

(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) Emergency Department Data--Events associated with hospital services in an emergency department or emergency room.

(22) Error--Data submitted on a event file which are not consistent with the format and data standards contained in this subchapter or with auditing criteria established by DSHS.

(23) Ethnicity--The status of patients relative to Hispanic background. 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 with in the authority of a reporting hospital.

(25) Event claim--A set of computer records as specified in §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 term, "Transaction set."

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

(28) Facility--For the purposes of this subchapter a facility is a reporting hospital.

(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). A hospital may have more than one indicator.

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

(31) HCPCS--HCFA's Common Procedure Coding System (HCFA-Health Care Finance Administrations (Now called Centers for Medicare and Medicaid Services)).

(32) HIPPS--Health Insurance Prospective Payment System.

(33) Hospital--A public, for-profit, or nonprofit institution licensed as a general or special hospital (25 TAC §133.2(22)(52)), or a hospital owned by the state.

(34) ICD--International Classification of Disease.

(35) IRB--Institutional Review Board.

(36) Operating or Other Physician--The "physician" licensed by the 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 procedure most closely related to the principal diagnosis.

(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 reporting hospital to examine, observe or treat patients.

(38) Panel--Scientific Review Panel.

(39) Patient account number--A number assigned to each patient by the hospital, which appears on each computer record in a patient event claim. This number is not consistent for a given patient from one hospital to the next, or from one admission to the next in the same 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.

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

(42) Public use data file--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. 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) 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.

(45) Required minimum data set--The list of data elements for which reporting hospitals may submit an event claim for each patient event occurring in the hospital. The required minimum data set is specified in §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 the data elements that are required by the ANSI 837 Institutional 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).

(46) Research data file--A customized data file, which 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. The data elements may be released to a requestor when the requirements specified in §1301.67(j) of this title (relating to Release of Ambulatory Surgical Care and Emergency Department Data from Reporting Hospitals) are completed.

(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. Described in §1301.69 of this title (relating to Scientific Review Panel).

(48) Submission--The transfer of a set of computer records as specified in §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 reporting hospitals and submits them under this subchapter. A submitter may be a hospital or an agent designated by a hospital or its owner.

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

(51) THCIC Identification Number--A string of 6 characters assigned by DSHS to identify hospitals for reporting and tracking purposes.

(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 hospitals and patient events. The relationship of the identifier to the patient-specific data elements used to assign it is confidential.

(53) Uniform physician identifier--A unique identifier assigned by the Council to a physician or other health professional who is reported as attending or treating a patient in a hospital and which remains constant across 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.

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

§1301.62.Collection of Ambulatory Surgical Care and Emergency Department Data.

(a) Reporting hospitals in operation for all or any of the reporting periods described in §1301.63 of this title (relating to Schedule for Filing Event Files) may submit event claims as specified in §1301.68 of this title (relating to Event Files--Records, Data Fields and Codes) on all patient events to DSHS. 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 §1301.68(d)(33)-(36) of this title shall be filled accordingly or data elements §1301.68(d)(38) or (41) shall be marked with one of DSHS approved temporary "Physician" or "Other health professional" code numbers and data elements §1301.68(d)(31)(A-C) or (34)(A-C) may be left blank. .

(b) All patient events shall be reported by the reporting hospitals, for which the reporting hospital prepares one or more bills for patient services, the reporting hospital shall submit an event claim corresponding to each bill containing the data elements required by §1301.68 of this title (relating to Event Files - Records, Data Fields and Codes). For all patients for which the hospital does not prepare a bill for patient services, the hospital shall submit an event claim containing the required minimum data set.

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

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

(e) 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 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) Reporting hospitals may submit event files themselves, or may designate an agent to submit the event files. If a 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 reporting hospital shall inform DSHS in writing at least 30 calendar days prior to changing agents or making the submissions itself.

§1301.63.Schedule for Filing Event Files.

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

(1) Each event claim covering patient events occurring between January 1 and March 31, inclusive, shall be submitted no later than June 1 of the calendar year in which the discharge occurred.

(2) Each event file covering patient events occurring between April 1 and June 30, inclusive, shall be submitted no later than September 1 of the calendar year in which the discharge occurred.

(3) Each event file covering patient events occurring between July 1 and September 30, inclusive, shall be submitted no later than December 1 of the calendar year in which the discharge occurred.

(4) Each event file covering patient events occurring between October 1 and December 31, inclusive, shall be submitted no later than March 1 of the year following the year in which the discharge occurred.

(b) Extensions to processing due dates may be granted by DSHS in response to a written request signed by the 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.

§1301.64.Instructions for Filing Event Files.

(a) Electronic Data Interchange. Event files may be filed 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 §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 reporting hospitals at no charge and to the public for the cost of reproduction. DSHS shall notify hospitals reporting under this subchapter and their designated agents directly in writing at least 90 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 reporting hospitals at no charge and to the public for the cost of reproduction or on DSHS' Internet website. DSHS shall notify hospitals reporting under this subchapter and their designated agents directly in writing at least 90 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.

§1301.65.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 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 §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 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 §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 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 reporting hospital disagrees with any identified error, the hospital may indicate that the discharge claim is as accurate as it can be or cannot be corrected. Each 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 §1301.66 of this title (relating to Certification of Compiled Event Data). Corrections to a event file shall be submitted on approved media and formats as specified in §1301.64 of this title (relating to Instructions for Filing Event Files) and §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 reporting hospital, DSHS shall notify the reporting hospital of any remaining errors. The 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 reporting hospital is able to certify the event file as required by §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 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 §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 §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 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 reporting hospitals.

§1301.66.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 reporting hospital using the event claims received from each 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 reporting hospitals, allows the reporting hospital to provide physicians and other health professionals the opportunity to review, request correction of, and comment on patients for whom and event occurred under the jurisdiction of the 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 reporting hospitals.

(b) The chief executive officer or chief executive officer's designated agent of each reporting hospital shall mark the appropriate box on the form provided whether the 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.

(c) The signed certification form shall represent that:

(1) policies and procedures are in place within the 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 reporting hospital have been corrected or the 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 reporting hospital's administrative status of discharged patients for the reporting quarter; and

(4) the 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 §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 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 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 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 §1301.63(a)(1)-(4) of this title (relating to Schedule for Filing Event Files). DSHS may extend the deadline for any or all reporting hospitals when deemed necessary.

(e) Reporting hospitals, physicians or other health professionals may submit concise written comments regarding any data submitted by the associated 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 §1301.64(a) and (b) of this title (relating to Instructions for Filing Event Files).

(f) Failure to submit a signed certification form that is supplied by DSHS on or before the dates specified in subsection (d) of this section corresponding to event data previously submitted shall be considered as not certified.

§1301.67.Release of Ambulatory Surgical Care and Emergency Department Data from Reporting Hospitals.

(a) DSHS shall review and verify the accuracy of the data. Until DSHS determines the data are reliable and valid, data, tables or reports generated from ambulatory surgical care data and emergency department data are not subject to Texas Public Information Act. After DSHS determines the data are reliable and valid, the hospital ambulatory surgical care data or hospital emergency department data, and subsequent reports may be published and made available to the public, on a time schedule DSHS considers appropriate. 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's office and are exempt from disclosure pursuant to Health and Safety Code, §108.010 and §108.013, and shall not be released. Likewise, patient and physician identifying data collected by DSHS through editing of the reporting hospital data shall not be released. Reporting hospital data collected under this subchapter and determined by DSHS in consultation with the Health Data Collection Workgroup as not reliable or valid shall be kept confidential and not released to the public.

(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 discharge record.

(c) Creation of public use data file. DSHS will create a public use data file by creating a single record for each patient event and adding, modifying or deleting data elements in the following manner as listed in paragraphs (1)-(8) of this subsection:

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

(2) convert patient birth date to age;

(3) convert admission and discharge dates to a length of stay measured in days and a code for the day of the week of the admission;

(4) convert procedure and occurrence dates to day of stay 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 "attending" or "operating or other" on discharged patients;

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

(7) the minimum cell size required by §108.011(i)(2) of the Health and Safety Code shall be 5, unless DSHS determines that a higher cell size is required to protect the confidentiality of an individual patient or physician. When determining a higher cell size, DSHS shall consider comments submitted by a hospital;

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

(A) Discharge Year and Quarter;

(B) Provider Name (Facility Name);

(C) THCIC Identification Number;

(D) Facility Type Indicators;

(E) Patient Sex/Gender;

(F) Type of Admission;

(G) Source of Admission;

(H) Patient ZIP Code;

(I) County Code;

(J) Public Health Region Code;

(K) Patient State;

(L) Patient Status;

(M) Patient Race;

(N) Patient Ethnicity;

(O) Claim Type Indicator;

(P) Type of Bill;

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

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

(S) Principal Procedure code (if applicable) (Current version of ICD or CPT codes at the time data is submitted);

(T) Other Procedure codes (Up to 24 procedure codes can be submitted and reported) (Current version of ICD or CPT codes at the time data is submitted);

(U) Patient's Reason for Visit (Current version of ICD or CPT codes at the time data is submitted);

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

(W) Day of Week Patient is admitted code (Sun. = 1, Mon. = 2, Tues. = 3, Wed. = 4, Thur. = 5, Fri. = 6, Sat. = 7);

(X) Length of Stay;

(Y) Age of patient;

(Z) HCFA-DRG Code (Obtained from the 3M HCFA-DRG Grouper);

(AA) Uniform Physician Identifier assigned to Attending Physician;

(BB) Uniform Physician Identifier assigned to Operating or Other Physician;

(CC) Ambulatory Payment Classifications (APC);

(DD) Ancillary Service--Other Charges;

(EE) Ancillary Service--Pharmacy Charges;

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

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

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

(II) Ancillary Service--Physical Therapy Charges;

(JJ) Ancillary Service--Occupational Therapy Charges;

(KK) Ancillary Service--Speech Pathology Charges;

(LL) Ancillary Service--Inhalation Therapy Charges;

(MM) Ancillary Service--Blood Charges;

(NN) Ancillary Service--Blood Administration Charges;

(OO) Ancillary Service--Operating Room Charges;

(PP) Ancillary Service--Lithotripsy Charges;

(QQ) Ancillary Service--Cardiology Charges;

(RR) Ancillary Service--Anesthesia Charges;

(SS) Ancillary Service--Laboratory Charges;

(TT) Ancillary Service--Radiology Charges;

(UU) Ancillary Service--MRI Charges;

(VV) Ancillary Service--Outpatient Services Charges;

(WW) Ancillary Service--Emergency Service Charges;

(XX) Ancillary Service--Ambulance Charges;

(YY) Ancillary Service--Professional Fees Charges;

(ZZ) Ancillary Service--Organ Acquisition Charges;

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

(BBB) Ancillary Service--Clinic Visit Charges;

(CCC) Total Charges--Ancillary;

(DDD) Total Non-Covered Ancillary Charges;

(EEE) Total Charges;

(FFF) Total Non-Covered Charges;

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

(HHH) Service Line Revenue Code;

(III) Service Line Procedure Code;

(JJJ) HCPCS/HIPPS Procedure Code;

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

(LLL) Service Line Charge Amount;

(MMM) Service Line Unit Code;

(NNN) Service Line Unit Count;

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

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

(d) Texas State agencies that request data solely for internal use in accordance with Health and Safety Code, §108.012(b,) shall abide by the data users agreement.

(e) DSHS shall establish procedures for screening all requests to assure that filling the request will not violate the provisions of Health and Safety Code, §108.013(c).

(f) The data elements specified for event files in §1301.68 of this title (relating to Event Files--Records, Data Fields and Codes) do not constitute "Provider Quality Data" as discussed in Health and Safety Code, §108.010.

(g) A public use data file, which is specified by the requestor, shall not be considered a "report issued by DSHS" as referenced in Health and Safety Code, §108.011(f).

(h) Requests for data files including data on one or more providers are matters of public record and DSHS shall maintain copies of all requests for two years from the date of receipt. DSHS shall make available on DSHS' Internet site and publish in DSHS' numbered letter for reporting hospitals a summary of all requests received for public use data.

(i) With any public use data file prepared by 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 on DSHS' Internet site.

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

(1) DSHS has determined, subject to this rule, that data are reliable and valid.

(2) the Ambulatory Surgical Care and Emergency Department Research Data Request Form is completed and submitted to DSHS;

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

(4) DSHS' Scientific Review Panel grants authorization to the request or restricts access to specified data elements determined to be inappropriate for the research proposal in accordance with this subsection of this section (relating to Scientific Review Panel);

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

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

§1301.68.Event Files--Records, Data Fields and Codes.

(a) 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. ANSI updates this format from time to time by issuing new versions.

(b) DSHS will make detailed specifications for these data elements available to submitters and to the public.

(c) In addition to the data elements contained in the ANSI 837 Institutional Guide, DSHS has specified the location where each the following data elements in this subsection shall be reported in the ANSI 837 Institutional format Guide. Data element content, format and locations may change as state legislative requirements or federal legislative 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 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 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 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 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 in the following ANSI X12N Form 837 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).

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

(A) Loop 2010AA associated with the "Billing Provider"; or

(B) Loop 2010AB associated with the "Pay-to provider"; or

(C) Loop 2310E associated with the "Service Facility Provider".

(d) Reporting hospitals shall submit the required minimum data set for all patients for which an event claim is required by this subchapter. The required minimum data set includes the following data elements as listed in this subsection:

(1) Patient Name:

(A) Patient Last Name;

(B) Patient First Name; and

(C) Patient Middle Initial.

(2) Patient Address:

(A) Patient Address Line 1;

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

(C) Patient City;

(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;

(10) Claim Filing Indicator Code (primary and secondary);

(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;

(14) Statement Dates;

(15) Start of Care:

(A) Start of Care Date; and

(B) Start of Care Hour;

(16) Patient (Discharge) Status;

(17) Patient Discharge Hour;

(18) Principal Diagnosis;

(19) Patient's Reason for Visit;

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

(21) Other Diagnosis Codes - up to 24 occurrences (all applicable);

(22) Principal Procedure Code (if applicable);

(23) Principal Procedure Date (if applicable);

(24) Other Procedure Codes - up to 24 occurrences (if applicable);

(25) Other Procedure Dates - up to 24 occurrences (if applicable);

(26) Occurrence Code - up to 24 occurrences (if applicable);

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

(28) Value Code - up to 24 occurrences (if applicable);

(29) Value Code Associated Amount - up to 24 occurrences (if applicable);

(30) Condition Code - up to 24 occurrences (if applicable);

(31) Attending Physician or Attending Practitioner Name:

(A) Attending Practitioner Last Name;

(B) Attending Practitioner First Name; and

(C) Attending Practitioner Middle Initial.

(32) Attending Practitioner Primary Identifier (National Provider Identifier, when HIPAA rule is implemented);

(33) Attending Practitioner Secondary Identifier (Texas state license number or UPIN);

(34) Operating Physician or Other Practitioner Name (if applicable):

(A) Operating Physician or Other Practitioner Last Name;

(B) Operating Physician or Other Practitioner First Name; and

(C) Operating Physician or Other Practitioner Middle Initial.

(35) Operating Physician or Other Practitioner Primary Identifier (National Provider Identifier, when HIPAA rule is implemented);

(36) Operating Physician or Other Practitioner Secondary Identifier (Texas state license number or UPIN);

(37) Total Claim Charges;

(38) Revenue Service Line Details (up to 999 service lines) (all applicable);

(A) Revenue Code;

(B) Procedure Code;

(C) HCPCS/HIPPS Procedure Modifier 1;

(D) HCPCS/HIPPS Procedure Modifier 2;

(E) HCPCS/HIPPS Procedure Modifier 3;

(F) HCPCS/HIPPS Procedure Modifier 4;

(G) Charge Amount;

(H) Unit Code;

(I) Unit Quantity;

(J) Unit Rate; and

(K) Non-covered Charge Amount.

(39) Service Provider Name;

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

(41) Service Provider Address:

(A) Service Provider Address Line 1;

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

(C) Service Provider City;

(D) Service Provider State; and

(E) Service Provider ZIP; and

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

§1301.69.Scientific Review Panel.

(a) DSHS establishes the Scientific Review Panel (Panel) for the purposes of:

(1) evaluating applications for various measures or variables in the ambulatory surgical care and emergency department data "research" file; and

(2) deciding whether the data requests should be granted.

(b) The Scientific Review Panel is abolished at such time as DSHS ceases to maintain an ambulatory surgical care and emergency department data "research" file.

(c) DSHS may establish the scientific review function through a contract with an existing institutional review board that meets federal guidelines or by appointing a separate review panel.

(d) Membership if Scientific Review Panel is appointed. The Scientific Review Panel will consist of the Department of State Health Services Institutional Review Board (DSHS IRB).

(e) Meetings.

(1) The Scientific Review Panel shall meet as necessary to conduct business, but in any case, at least once every three months if applications for all or part of the research file are pending.

(2) A simple majority of the members of the Scientific Review Panel shall constitute a quorum for the purpose of transacting business. All action of the Panel must be approved by majority vote. Each member shall have one vote and may not vote by proxy or in absentia.

(3) Meetings of the Panel or Subcommittees of the Panel shall be posted and conducted in accordance with the Texas Open Meetings Act, Government Code, Chapter 551. All meetings of the Panel or any Subcommittee will be recorded.

(4) Minutes of all Panel and Subcommittee meetings shall be maintained by DSHS staff and shall include the names of members in attendance and a record of all formal actions and votes taken.

(5) DSHS staff shall provide administrative support for the Panel and any Subcommittees, including making of meeting arrangements. Each Panel or Subcommittee member shall be informed of a meeting at least 10 calendar days prior to a meeting.

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

(f) Decision-Making Guidelines.

(1) Requests should reasonably identify and justify the requested data elements. Requesters who have detailed information that would assist in justifying the records request are urged to provide such information in order to expedite the handling of the request. Envelopes in which written requests are submitted should be clearly identified as Open Records requests. Requests should include the fee or request determination of the fee.

(2) Fee structures for the public use data file and the research file shall be set by DSHS in consultation with the "Health Data Collection Workgroup".

(3) Waiver or reduction of the fees charged for the public use data file or the research file may be made upon a determination by DSHS in consultation with the "Health Data Collection Workgroup" when such waiver or reduction is in the best interest of the State of Texas and it's citizens.

(4) All requests for data must be submitted in writing, either on the form provided by DSHS or on a similar form containing all of the same information. Denials of written requests will be in writing and will contain the reasons for the denial including, as appropriate, a statement that a document or data element requested is nonexistent or is not reasonably described, or is subject to one or more clearly described exemption(s). Denials will also provide the requester with appropriate information on how to exercise the right of appeal to the DSHS.

(5) In cases where there is an alleged conflict between the Texas Public Information Act and DSHS' procedures, DSHS will refer the issue to the Office of the Attorney General.

(6) Only data elements requested by the requestor and approved for release by the Scientific Review Panel, shall be included in the research file for release to the requestor in accordance with this subchapter.

(g) Reports to the DSHS. The Chair of the Scientific Review Panel shall file with DSHS a written report of all action taken at any meeting of the Panel or of a Subcommittee within three working days of such meeting, including a detailed list of how each participating member voted.

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 21, 2004.

TRD-200404067

Lewis E. Foxhall, M.D.

Presiding Officer

Texas Health Care Information Council

Earliest possible date of adoption: August 1, 2004

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