TITLE 25. HEALTH SERVICES

PART 1. DEPARTMENT OF STATE HEALTH SERVICES

CHAPTER 421. HEALTH CARE INFORMATION

The Executive Commissioner of the Health and Human Services Commission, on behalf of the Department of State Health Services (DSHS), adopts amendments to §§421.1, 421.4, 421.6 - 421.9, and repeals of §421.5 and §421.10, concerning collection and release of hospital discharge data; new §§421.45 - 421.47, concerning reports, data requests, and data fees; amendments to §§421.61, 421.64, 421.66 - 421.68, and new §421.69, concerning collection and release of outpatient surgical and radiological procedures at hospitals and ambulatory surgical centers; amendments to §§421.71, 421.78, and new 421.79, concerning collection and release of hospital outpatient emergency room data; and new §421.81, concerning health care facility exemptions.

The amendments to §§421.4, 421.7, 421.8, 421.66, 421.68, and 421.78 are adopted with changes to the proposed text as published in the March 31, 2017, issue of the Texas Register (42 TexReg 1703). The amendments to §§421.1, 421.6, and 421.9; the repeals of §421.5 and §421.10; new §§421.45 - 421.47; amendments to §§421.61, 421.64, and 421.67 and new 421.69; amendments to §421.71 and new §421.79; and new §421.81 are adopted without changes to the proposed text as published in the March 31, 2017, issue of the Texas Register and will not be republished.

BACKGROUND AND JUSTIFICATION

The amendments, new sections, and repealed sections are necessary to comply with the following Legislative bills and Sunset Advisory Commission recommendations.

Senate Bill (SB) 219 (84th Texas Legislature Regular Session) amended Health and Safety Code, Chapter 108 and requires that fees for the recoupment and support of the program be established in the rules.

House Bill (HB) 2641 (84th Texas Legislature, Regular Session) amended Government Code, §531.0162 and requires that any data collection efforts that are implemented after September 1, 2015, to use the American National Standards Institute (ANSI) approved formats and the 2014-2015 Sunset Advisory Commission Recommendation 7.1 Modification 3 for the Texas Health Care Information Collection program (THCIC) within DSHS to reduce the time for health care facilities to certify the data submitted to DSHS and consolidate and clarify the rules. The amendments update technology language on how data is stored for transfer. The amendments consolidate language that is repetitive in several sections regarding similar processes for data requests and release of public use data and research data files, which requires the Institutional Review Board approval.

The purpose of the amendments to §421.9(c)(1) - (2) and §421.67(c)(1) - (2) were necessary to comply with changes made to the Government Code, §531.0162, by HB 2641, 84th Regular Legislative Session, which requires the department rules to be applicable to the data exchange standards developed by the ANSI. By moving the location of the data fields for the patient ethnicity and patient race and moving the patient's social security number over two characters in the information system will satisfy the Health Insurance Portability and Accountability Act of 1996 (HIPAA) and subsequent amendments and revisions requirements which are outlined in Government Code, §531.0162.

COMMENTS

The 30-day comment period ended on May 1, 2017. DSHS has reviewed and prepared responses to comments regarding the proposed rules that were submitted during the 30-day comment period.

During the comment period, DSHS received comments regarding the proposed rules from two commenters, including the Dallas Fort Worth Hospital Council Foundation and the Texas Ambulatory Surgery Center Society.

DSHS has prepared responses to the comments received regarding the proposed rules. The commenters were not against the rules in their entirety; however, the commenters recommended changes as discussed in the summary of comments.

Comment: Regarding proposed §421.7(b) (reducing the deadline for submitting corrections at the time of certification) and §421.7(d) (reducing the certification period by two months), the Dallas Forth Worth Hospital Council Foundation provided a written comment that the 30-day timeframe to perform the required validation, including the physician validation of reports was too short and recommended a 60-day certification deadline.

Response: HHSC disagrees with revising the certification deadline to 60 days but agrees to extend the correction at time of certification to 30 days in §421.7(b) and the certification period to 45 days instead of the commenter's suggested time of 60 days in §421.7(d).

Comment: Regarding proposed "§421 et al, not shorten the time for ASCs (ambulatory surgery centers) to certify the requested information from THCIC and the certification time limit for ASCs remain 90 days" as suggested by the Texas Ambulatory Surgery Center Society. DSHS staff assumes the amendments to §421.66(d) is the subsection referred to by the commenter, because that subsection is the only subsection in 25 TAC Chapter 421 that addresses the certification deadline affecting ASCs.

Response: HHSC disagrees with retaining the certification period at 90 days but agrees to extend the proposed 30-day certification period to 45 days in §421.7(d) and §421.66(d).

Comment: The Texas Ambulatory Surgery Center Society submitted a comment regarding DSHS referencing the "2014-2015 Sunset Advisory Commission Recommendation 7.1 Modification 3" in the preamble as statutory authority for proposing the change in §421.7(d) and §421.66(d) from 90 days to 30 days to reduce the time for facilities to certify the data submitted to DSHS.

Response: HHSC acknowledges the comment. The Sunset Advisory Commission was created by the legislature, is charged with monitoring state agency performance, and is authorized by Government Code, Chapter 325 to make recommendations, such as amendments to rules. They did so here, and HHSC considered the recommendation and proposed the amendments to §421.7(d) and §421.66(d).

On May 9, 2017, the THCIC program staff arranged a conference call meeting with the Data Collection Workgroup. This informal group meets periodically at the request of staff to discuss issues that may affect data collection, providers, researchers, publications, or data release. This meeting was called by staff to discuss the issues and concerns of the stakeholders on moving the certification period to 45 days or 60 days. The following organizations participated in the conference call: Baylor-Scott & White Health System; Dallas-Fort Worth Hospital Council Foundation; DSHS; Texas A&M Health Science Center; Texas Association of Businesses; Texas Hospital Association; RPC Consulting and System13, Inc. A summary of the comments and responses follows.

Comment: Concerning §421.7(d) and §421.66(d), the Data Collection Workgroup did not oppose the rules in their entirety; Dallas Fort Worth Hospital Council Foundation and the Texas Hospital Association did, however, express a concern that the 30-day certification period was too short for the health care facilities to make changes to their data. These representatives stated that the facility's vendors generally took more than 30 days to make changes to the information systems. They also noted that the physician review and comment requirement (Health and Safety Code, §108.011(g)) requires a significant amount of time for the outpatient data, due to the large number of physicians that are in some health care facilities. The Data Collection Workgroup had a consensus that 45 days is an acceptable time for the quarterly certification deadline.

Response: HHSC agrees to modify the certification period and has changed the certification period in communication with the Data Collection Workgroup to 45 days. The changes were made because the Sunset Advisory Commission's recommendation of 30 days for certification, which was proposed, creates a burden on the health care facilities to meet the deadline. Extending the certification period will provide additional time for the health care facilities required to submit the data under Health and Safety Code, Chapter 108, and to correct any erroneous data that is identified during this certification period.

HHSC has extended the certification period from the proposed 30 days to 45 days in §421.7(d) and §421.66(d). The certification period will have a due date of the fifteenth day of the seventh month (Quarter 1- October 15; Quarter 2- January 15; Quarter 3- April 15; and Quarter 4- July 15) after the end of the reporting period.

Also, HHSC has extended the correction at the time of certification deadline from the proposed 15 days to 30 days in §421.7(b) and §421.66(b) to be within the certification period in §421.7(d) and §421.66(d). The corrections at the time of certification will have the due date of the first day of the month (Quarter 1- October 1; Quarter 2- January 1; Quarter 3- April 1; and Quarter 4- July 1.)

Comment: Texas Ambulatory Surgery Center Society, which is a member of the Data Collection Workgroup, did not participate in the conference call but contacted THCIC staff approximately one hour after the meeting. The commenter expressed that they preferred that the certification period in §421.66(d) should remain at 90 days. Alternatively, the commenter stated that changing the certification period to 60 days is a workable time period.

Response: HHSC disagrees to retain the 90-day certification period or change the certification period to 60 days because the Sunset Advisory Commission made a recommendation to shorten the certification time period. However, HHSC agreed to extend the certification period from the proposed 30 days to 45 days.

The following language was revised to update rule and statute references.

The following language "The department's instructions shall follow Department of Information Resources standards for data storage media established under 1 TAC Chapter 201." was removed from §421.4(a)(4), as the Department of Information Resources rules in 1 TAC no longer addresses standards for magnetic data storage.

Health and Safety Code, §108.011(i)(2) was corrected to §108.011(i) in §421.8(c)(7), §421.68(d)(7) and §421.78(d)(7) due to the removal of numbering by SB 219, but the same language applies.

SUBCHAPTER A. COLLECTION AND RELEASE OF HOSPITAL DISCHARGE DATA

25 TAC §§421.1, 421.4, 421.6 - 421.9

The amendments are adopted under Health and Safety Code, §§108.006, 108.009 - 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, establish fees for the recoupment and support of the program, and disseminate data as authorized by the chapter regarding hospital inpatient stays, hospital and ambulatory surgical center outpatient visits including hospital emergency department visit data in public use data files and the DSHS Institutional Review Board approved research data files; 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 DSHS and for the administration of Health and Safety Code, Chapter 1001.

§421.4.Instructions for Filing Discharge Reports.

(a) Portable Data Storage Media. A discharge report may be filed on computer diskettes, USB flash drive, or other portable data storage media approved by the department. All discharges shall be reported using the same file and record formats specified in §421.9 of this title (relating to Discharge Reports--Records, Data Fields and Codes) regardless of medium.

(1) Media specifications are:

(A) Optical Media: Devices or disc that uses digital optical disc data storage format, for example Compact Disc (CD) or Digital Video Disc (DVD): MS-DOS formatted; PC Text file (ASCII).

(B) Universal Serial Bus (USB) flash drive: portable data memory device using flash memory with a USB interface.

(C) Other electronic, magnetic or other portable data storage media: Discharge reports may be filed on other data storage media only with the prior written approval of the department. The department will not normally approve any medium which the department is not currently equipped to read.

(2) Hospitals shall submit no more than one tape or two diskettes per submission, with the following external identification affixed as listed in subparagraphs (A) - (G) of this paragraph:

(A) hospital name;

(B) facility identifier (THCIC 6 digit identifier);

(C) reporting period for discharges;

(D) number of transaction sets;

(E) tape density: 1600/6250 BPI (if applicable);

(F) collating sequence for tapes (if applicable);

(G) the description: "DISCHARGE DATA."

(3) Data for more than one hospital may be submitted on a single tape if the submitter provides external identification items in subparagraphs (A) - (D) of this paragraph for each hospital.

(4) In addition to the provisions of this section, the department shall document instructions for filing discharge reports on data storage media and shall make this documentation available to hospitals at no charge and to the public for the cost of reproduction. The department shall notify hospitals or their designated agents directly in writing at least 90 days in advance of any change in instructions for filing discharge reports on data storage media.

(b) Electronic Data Interchange. Discharge reports may be filed by modem using electronic data interchange (EDI). All discharges shall be reported using the same file and record formats specified in §421.9 of this title regardless of the medium of transmission, unless the hospital has obtained an exemption authorized by §421.81 of this title (relating to Health Care Facilities Exemptions from Filing Requirements). The department shall document instructions for filing discharge reports by EDI and shall make this documentation available to hospitals at no charge and to the public for the cost of reproduction. The department shall notify hospitals and their designated agents directly in writing at least 90 days in advance of any change in instructions for filing discharge reports by EDI. The department's instructions shall follow Department of Information Resources standards for EDI.

§421.7.Certification of Discharge Reports.

(a) Within five months after the end of each reporting quarter, the department shall compile one or more electronic data files for each reporting hospital using all discharge claims received from each hospital. The file shall have one record for each patient discharged during the reporting quarter and one record for any patient discharged during one prior reporting quarter for whom additional discharge claims have been received. This file will include all data submitted by the hospital, which the department intends to use in the creation of the public use data file. The data files, including reports and any additional information returned to the hospital, allows the hospital to provide physicians and other health professionals the opportunity to review, request correction of, and comment on records of discharged patients for whom they are shown as "attending" or "operating or other". The department shall determine the format and medium in which the quarterly file will be delivered to hospitals.

(b) The chief executive officer or chief executive officer's designated agent of each hospital shall indicate whether the hospital is certifying or not certifying the discharge encounter data specified in subsection (a) of this section, sign and return the form corresponding to the discharge report for each quarter using forms supplied by the department. The certification form may be signed by a person designated by the chief executive officer and acting as the officer's agent. 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 the department with detailed comments regarding the errors or submit a written request (on a form supplied by the department) and provide the data necessary to correct any inaccuracy and certify the file subject to those corrections being made prior to the deadlines specified in this subsection. Corrections to certification discharge data shall be submitted on or prior to the following schedule: Quarter 1- October 1; Quarter 2- January 1; Quarter 3- April 1; and Quarter 4- July 1. 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 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 hospital's processes to validate and assure the accuracy of the discharge encounter data and any corrections submitted; and

(2) all errors and omissions known to the hospital have been corrected or the 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 hospital's administrative status of discharged inpatients for the reporting quarter; and

(4) the hospital has provided physicians and other health professionals a reasonable opportunity to review and comment on the discharge 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 §421.9 of this title (relating to Discharge Reports--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 the chief executive officer or the chief executive officer's designated agent, shall address any comments by the physicians or other health professionals.

(5) if the chief executive officer or the officer's designee elects not to certify the discharge encounter data 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. Discharge data that has been edited, returned to hospital and is not certified may be released and published in the public use data file.

(d) Each hospital shall submit its certification form for each quarter's data to the department by the fifteenth day of the seventh month (Quarter 1- October 15; Quarter 2- January 15; Quarter 3- April 15; and Quarter 4- July 15) following the last day of the reporting quarter as specified in §421.3(a)(1) - (4) of this title (relating to Schedule for Filing Discharge Reports). Individual hospital requests for an extension to these deadlines will not be granted. The department may extend the deadline for all hospitals when deemed necessary.

(e) Hospitals, physicians or other health professionals may submit concise written comments regarding any data submitted by them or relating to services, they have delivered which may be released as public use data. Comments shall be submitted to the department 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 §421.4(a) and (b) of this title (relating to Instructions for Filing Discharge Reports).

(f) Failure to either correct a discharge report which has been submitted and contains errors or omissions known to the hospital on or prior to the dates specified in subsection (b) of this section or to address in the comments the errors known to the hospital contained in the data and return the comments on or prior to the dates specified in subsection (d) of this section is punishable by a civil penalty pursuant to Health and Safety Code, §108.014(b).

§421.8.Hospital Discharge Data Creation.

(a) Department records are public records under Government Code, Chapter 552, except as specifically exempted by Health and Safety Code, §108.010 and §108.013. Copies of such records may be obtained upon request and upon payment of user fees established by the department. The public use data file shall be available for public inspection during normal business hours. Discharge claims in the original format as submitted to the department are not available to the public, are not stored at the department'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 the department through editing of hospital data shall not be released.

(b) Creation of codes and identifiers. The department 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) The executive director 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) The executive director shall create a process for assigning geographic identifiers to each discharge record.

(c) Creation of public use data file. The department will create a public use data file by creating a single record for each inpatient discharge and adding, modifying or deleting data elements in the following manner as listed in paragraphs (1) - (11) 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) of the Health and Safety Code shall be five, unless the department determines that a higher cell size is required to protect the confidentiality of an individual patient or physician;

(8) convert all procedure codes to ICD 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 risk and severity adjustment scores utilizing an algorithm approved by the department;

(10) suppress admission source data at patient level when the admission type code represents "Newborn;"

(11) 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 Code;

(P) Type of Bill;

(Q) Encounter Indicator: This indicates whether more than one claim was used to create the encounter;

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

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

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

(U) Other Procedure codes (Up to 24 procedure codes can be submitted and report Current version of ICD codes at the time data is submitted);

(V) Admitting Diagnosis (Current version of ICD codes at the time data is submitted);

(W) 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;

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

(Y) Length of Stay;

(Z) Age of patient;

(AA) Day number of Principal Procedure (Calculated: Principal Procedure Date minus Admission/Start of Care Date);

(BB) Day number of Procedure (1) (Calculated: Procedure Date (1) minus Admission/Start of Care Date);

(CC) Day number of Procedure (2) (Calculated: Procedure Date (2) minus Admission/Start of Care Date);

(DD) Day number of Procedure (3) (Calculated: Procedure Date (3) minus Admission/Start of Care Date);

(EE) Day number of Procedure (4) (Calculated: Procedure Date (4) minus Admission/Start of Care Date);

(FF) Day number of Procedure (5) (Calculated: Procedure Date (5) minus Admission/Start of Care Date);

(GG) Major Diagnostic Category (MDC);

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

(II) APR-DRG Code (Obtained from 3M APR-DRG Grouper);

(JJ) Risk of Mortality Score (Obtained from 3M APR-DRG Grouper);

(KK) Severity of Illness Score (Obtained from 3M APR-DRG Grouper);

(LL) Uniform Physician Identifier assigned to Attending Physician;

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

(NN) Service unit indicator from which the patient received services;

(OO) Accommodations Private Room Charges;

(PP) Accommodations Semi-Private Charges;

(QQ) Accommodations Ward Charges;

(RR) Accommodations Intensive Care Charges;

(SS) Accommodations Coronary Care Charges;

(TT) Ancillary Service - Other Charges;

(UU) Ancillary Service - Pharmacy Charges;

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

(WW) Ancillary Service - Durable Medical Equipment Charges;

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

(YY) Ancillary Service - Physical Therapy Charges;

(ZZ) Ancillary Service - Occupational Therapy Charges;

(AAA) Ancillary Service - Speech Pathology Charges;

(BBB) Ancillary Service - Inhalation Therapy Charges;

(CCC) Ancillary Service - Blood Charges;

(DDD) Ancillary Service - Blood Administration Charges;

(EEE) Ancillary Service - Operating Room Charges;

(FFF) Ancillary Service - Lithotripsy Charges;

(GGG) Ancillary Service - Cardiology Charges;

(HHH) Ancillary Service - Anesthesia Charges;

(III) Ancillary Service - Laboratory Charges;

(JJJ) Ancillary Service - Radiology Charges;

(KKK) Ancillary Service - MRI Charges;

(LLL) Ancillary Service - Outpatient Services Charges;

(MMM) Ancillary Service - Emergency Service Charges;

(NNN) Ancillary Service - Ambulance Charges;

(OOO) Ancillary Service - Professional Fees Charges;

(PPP) Ancillary Service - Organ Acquisition Charges;

(QQQ) Ancillary Service - ESRD Revenue Setting Charges;

(RRR) Ancillary Service - Clinic Visit Charges;

(SSS) Total Charges - Accommodations;

(TTT) Total Charges - Ancillary;

(UUU) Total Non-Covered Accommodation Charges;

(VVV) Total Non-Covered Ancillary Charges;

(WWW) Total Charges;

(XXX) Total Non-Covered Charges;

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

(ZZZ) Service Line Revenue Code;

(AAAA) Service Line Procedure Code;

(BBBB) HCPCS/HIPPS Procedure Code;

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

(DDDD) Service Line Charge Amount;

(EEEE) Service Line Unit Code;

(FFFF) Service Line Unit Count;

(GGGG) Service Line Non-Covered Charge Amount;

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

(IIII) POA indicator (if applicable).

The agency certifies that legal counsel has reviewed the adoption and found it to be a valid exercise of the agency's legal authority.

Filed with the Office of the Secretary of State on June 15, 2017.

TRD-201702334

Lisa Hernandez

General Counsel

Department of State Health Services

Effective date: July 5, 2017

Proposal publication date: March 31, 2017

For further information, please call: (512) 776-6972


25 TAC §421.5, §421.10

The repealed sections are adopted under Health and Safety Code, §§108.006, 108.009 - 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, establish fees for the recoupment and support of the program, and disseminate data as authorized by the chapter regarding hospital inpatient stays, hospital and ambulatory surgical center outpatient visits including hospital emergency department visit data in public use data files and the DSHS Institutional Review Board approved research data files; 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 DSHS and for the administration of Health and Safety Code, Chapter 1001.

The agency certifies that legal counsel has reviewed the adoption and found it to be a valid exercise of the agency's legal authority.

Filed with the Office of the Secretary of State on June 15, 2017.

TRD-201702335

Lisa Hernandez

General Counsel

Department of State Health Services

Effective date: July 5, 2017

Proposal publication date: March 31, 2017

For further information, please call: (512) 776-6972


SUBCHAPTER C. RULES RELATING TO REPORTS, DATA REQUESTS AND DATA FEES

25 TAC §§421.45 - 421.47

The new sections are adopted under Health and Safety Code, §§108.006, 108.009 - 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, establish fees for the recoupment and support of the program, and disseminate data as authorized by the chapter regarding hospital inpatient stays, hospital and ambulatory surgical center outpatient visits including hospital emergency department visit data in public use data files and the DSHS Institutional Review Board approved research data files; 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 DSHS and for the administration of Health and Safety Code, Chapter 1001.

The agency certifies that legal counsel has reviewed the adoption and found it to be a valid exercise of the agency's legal authority.

Filed with the Office of the Secretary of State on June 15, 2017.

TRD-201702336

Lisa Hernandez

General Counsel

Department of State Health Services

Effective date: July 5, 2017

Proposal publication date: March 31, 2017

For further information, please call: (512) 776-6972


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

25 TAC §§421.61, 421.64, 421.66 - 421.69

The amendments and new section are adopted under Health and Safety Code, §§108.006, 108.009 - 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, establish fees for the recoupment and support of the program, and disseminate data as authorized by the chapter regarding hospital inpatient stays, hospital and ambulatory surgical center outpatient visits including hospital emergency department visit data in public use data files and the DSHS Institutional Review Board approved research data files; 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 DSHS and for the administration of Health and Safety Code, Chapter 1001.

§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 using the event claims received from each facility. 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, allow the facility to provide physicians and other health professionals the opportunity to review, request correction of, and comment on patients for whom an event occurred under the jurisdiction of the facilities 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.

(b) The chief executive officer or chief executive officer's designated agent of each facility shall mark the appropriate box on the form provided indicating whether the facility 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 1; Quarter 2- January 1; Quarter 3- April 1; and Quarter 4- July 1. 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 facility'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 have been corrected or the facility 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 administrative status of patients for which the services covered by the revenue codes or surgical and radiological categories identified in §421.67(f) or §421.67(g) of this title (relating to Event File--Records, Data Fields and Codes) were provided for the reporting quarter; and

(4) the facility 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 of this title (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 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 and is not certified, may be released and published in the public use data file and used by DSHS for analysis.

(d) Each facility shall submit its certification form for each quarter's data to DSHS by the fifteenth day of the seventh month (Quarter 1- October 15; Quarter 2- January 15; Quarter 3- April 15; and Quarter 4- July 15) following the last day of the reporting quarter as specified in §421.63(a)(1) - (4) of this title (relating to Schedule for Filing Event Files). DSHS may extend the deadline for any or all facilities when deemed necessary.

(e) Facilities, physicians or other health professionals may submit concise written comments regarding any data submitted by the associated facilities 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) 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.

§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 any format as submitted to DSHS are not available to the public 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) 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.

(d) 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 "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), 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);

(C) THCIC Identification Number;

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

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

(R) 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);

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

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

(U) Age group of patient;

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

(LL) Ancillary Service--Other Charges;

(MM) Ancillary Service--Pharmacy Charges;

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

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

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

(QQ) Ancillary Service--Physical Therapy Charges;

(RR) Ancillary Service--Occupational Therapy Charges;

(SS) Ancillary Service--Speech Pathology Charges;

(TT) Ancillary Service--Inhalation Therapy Charges;

(UU) Ancillary Service--Blood Charges;

(VV) Ancillary Service--Blood Administration Charges;

(WW) Ancillary Service--Operating Room Charges;

(XX) Ancillary Service--Lithotripsy Charges;

(YY) Ancillary Service--Cardiology Charges;

(ZZ) Ancillary Service--Anesthesia Charges;

(AAA) Ancillary Service--Laboratory Charges;

(BBB) Ancillary Service--Radiology Charges;

(CCC) Ancillary Service--MRI Charges;

(DDD) Ancillary Service--Outpatient Services Charges;

(EEE) Ancillary Service--Emergency Service Charges;

(FFF) Ancillary Service--Ambulance Charges;

(GGG) Ancillary Service--Professional Fees Charges;

(HHH) Ancillary Service--Organ Acquisition Charges;

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

(JJJ) Ancillary Service--Clinic Visit Charges;

(KKK) Total Charges--Ancillary;

(LLL) Total Non-Covered Ancillary Charges;

(MMM) Total Charges;

(NNN) Total Non-Covered Charges;

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

(PPP) Service Line Revenue Code;

(QQQ) Service Line Procedure Code;

(RRR) HCPCS/HIPPS Procedure Code;

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

(TTT) Service Line Charge Amount;

(UUU) Service Line Unit Code;

(VVV) Service Line Unit Count;

(WWW) Service Line Non-Covered Charge Amount;

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

(YYY) Point of Origin (Source of Admission) (Hospital Emergency Department Visits only); and

(ZZZ) Patient Status (Hospital Emergency Department Visits only).

The agency certifies that legal counsel has reviewed the adoption and found it to be a valid exercise of the agency's legal authority.

Filed with the Office of the Secretary of State on June 15, 2017.

TRD-201702338

Lisa Hernandez

General Counsel

Department of State Health Services

Effective date: July 5, 2017

Proposal publication date: March 31, 2017

For further information, please call: (512) 776-6972


SUBCHAPTER E. COLLECTION AND RELEASE OF HOSPITAL OUTPATIENT EMERGENCY ROOM DATA

25 TAC §§421.71, 421.78, 421.79

The amendments and new section are adopted under Health and Safety Code, §§108.006, 108.009 - 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, establish fees for the recoupment and support of the program, and disseminate data as authorized by the chapter regarding hospital inpatient stays, hospital and ambulatory surgical center outpatient visits including hospital emergency department visit data in public use data files and the DSHS Institutional Review Board approved research data files; 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 DSHS and for the administration of Health and Safety Code, Chapter 1001.

§421.78.Outpatient Emergency Visit 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. Event claims in any format as submitted to DSHS are not available to the public 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) The data elements specified for outpatient emergency visit event reports in this section do not constitute "Provider Quality Data" as discussed in Health and Safety Code, §108.010.

(d) Creation of public use data file. DSHS will create a public use data file by creating a single record for each reportable outpatient emergency visit 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 "Attending", or "operating or other" 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), 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);

(C) THCIC Identification Number;

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

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

(R) 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);

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

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

(U) Age group of patient;

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

(LL) Ancillary Service--Other Charges;

(MM) Ancillary Service--Pharmacy Charges;

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

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

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

(QQ) Ancillary Service--Physical Therapy Charges;

(RR) Ancillary Service--Occupational Therapy Charges;

(SS) Ancillary Service--Speech Pathology Charges;

(TT) Ancillary Service--Inhalation Therapy Charges;

(UU) Ancillary Service--Blood Charges;

(VV) Ancillary Service--Blood Administration Charges;

(WW) Ancillary Service--Operating Room Charges;

(XX) Ancillary Service--Lithotripsy Charges;

(YY) Ancillary Service--Cardiology Charges;

(ZZ) Ancillary Service--Anesthesia Charges;

(AAA) Ancillary Service--Laboratory Charges;

(BBB) Ancillary Service--Radiology Charges;

(CCC) Ancillary Service--MRI Charges;

(DDD) Ancillary Service--Outpatient Services Charges;

(EEE) Ancillary Service--Emergency Service Charges;

(FFF) Ancillary Service--Ambulance Charges;

(GGG) Ancillary Service--Professional Fees Charges;

(HHH) Ancillary Service--Organ Acquisition Charges;

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

(JJJ) Ancillary Service--Clinic Visit Charges;

(KKK) Total Charges--Ancillary;

(LLL) Total Non-Covered Ancillary Charges;

(MMM) Total Charges;

(NNN) Total Non-Covered Charges;

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

(PPP) Service Line Revenue Code;

(QQQ) Service Line Procedure Code;

(RRR) HCPCS Procedure Code;

(SSS) HCPCS Procedure Modifiers (Up to 4 may be submitted and reported);

(TTT) Service Line Charge Amount;

(UUU) Service Line Unit Code;

(VVV) Service Line Unit Count;

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

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

The agency certifies that legal counsel has reviewed the adoption and found it to be a valid exercise of the agency's legal authority.

Filed with the Office of the Secretary of State on June 15, 2017.

TRD-201702340

Lisa Hernandez

General Counsel

Department of State Health Services

Effective date: July 5, 2017

Proposal publication date: March 31, 2017

For further information, please call: (512) 776-6972


SUBCHAPTER F. HEALTH CARE FACILITY EXEMPTIONS

25 TAC §421.81

The new section is adopted under Health and Safety Code, §§108.006, 108.009 - 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, establish fees for the recoupment and support of the program, and disseminate data as authorized by the chapter regarding hospital inpatient stays, hospital and ambulatory surgical center outpatient visits including hospital emergency department visit data in public use data files and the DSHS Institutional Review Board approved research data files; 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 DSHS and for the administration of Health and Safety Code, Chapter 1001.

The agency certifies that legal counsel has reviewed the adoption and found it to be a valid exercise of the agency's legal authority.

Filed with the Office of the Secretary of State on June 15, 2017.

TRD-201702341

Lisa Hernandez

General Counsel

Department of State Health Services

Effective date: July 5, 2017

Proposal publication date: March 31, 2017

For further information, please call: (512) 776-6972