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 (department), proposes amendments to §§421.1, 421.4, 421.6, 421.7, 421.8, and 421.9, and repeal of §421.5 and §421.10, concerning collection and release of hospital discharge data; new §§421.45, 421.46 and 421.47, concerning reports, data requests, and data fees; amendments to §§421.61, 421.64, 421.66, 421.67 and 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.

BACKGROUND AND PURPOSE

The amendments are necessary to implement the following Legislative bills and Sunset Review 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 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 Review Commission recommendation 7.1 Modification 3 for the Texas Health Care Information Collection program (THCIC) within the department to reduce the time for facilities to certify the data submitted to the department from ninety days to thirty days and consolidate and clarify the rules. The proposed amendments update technology language on how data is stored for transfer. The proposed amendments consolidate language that is repetitive in a several sections regarding similar processes for data requests and release of public use data and research data files, which requires Institutional Review Board approval.

The purpose of the amendments to §421.9(c)(1) - (2) and §421.67(c)(1) - (2) are necessary to comply with changes made to the Government Code, §531.0162, by HB 2641, 84th Regular Legislative Session, which requires the department 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.

SECTION-BY-SECTION SUMMARY

The amendment to §421.1(15) deletes the term "magnetic" and inserts the term "portable data storage." These revisions are made throughout the rule text to update technological advances in data storage.

The amendment to §421.1(26) updates the rule reference from §421.10 to §421.46 for the duties of the Institutional Review Board concerning research data file requests. Section 421.10 is being repealed and moved to new §421.46.

The amendment to §421.1(38) updates the title of §421.8 to "Hospital Discharge Data Creation" by deleting the word "Release" and adding the word "Creation."

The amendment to §421.4(a) deletes the term "Magnetic" and inserts the phrase "Portable Data Storage;" and deletes "nine track tapes" and inserts "USB flash drive."

The amendment to §421.4(a)(1)(A) deletes the term "Diskette" and inserts the phrase "Optical Media: Devices or disc that uses digital optical disc data storage format, for example Compact Disc (CD) or Digital Video Disc (DVD)." The following text is deleted "; 3.5 inch diskette, 1.4 megabyte, high density."

The amendment to §421.4(a)(1)(B) deletes the language "Nine track tape: Density = 1600 or 6250 BPI, nine track; Collating sequence = EBCDIC; Labeling = IBM standard or facsimile." and inserts the phrase "Universal Serial Bus (USB) flash drive: portable data memory device using flash memory with a USB interface."

The amendment to §421.4(a)(1)(C) inserts the word "electronic," between "other" and "magnetic." The phrase "or other portable data storage" is inserted between "magnetic" and "media." The phrase "data storage" replaces the second use of the word "magnetic."

The amendment to §421.4(a)(4) replaces the word "magnetic" with "data storage."

The amendment to §421.4(b) updates the rule reference from §421.5 to §421.81 and updates the title change for the new section. "Health Care Facilities" is inserted before "Exemptions from Filing Requirements."

The repeal of §421.5 deletes the language regarding hospital exemptions and moves the language to new §421.81, Health Care Facilities Exemptions from Filing Requirements.

The amendment to §421.6(d) deletes the word "or" between "paper" and "magnetic." A comma is inserted after "magnetic" and the text "or other portable data storage" is inserted between "magnetic" and "media." The revised text states "paper, magnetic, or other portable data storage media."

The amendment to §421.7(b) reduces the quarterly deadline dates by two months for corrections at the time of certification for the following quarters: for Quarter 1- "October" is deleted and "September" is inserted; for Quarter 2- "January" is deleted and "December" is inserted; for Quarter 3- "April" is deleted and "March" is inserted; and for Quarter 4- "July" is deleted and "June" is inserted.

The amendment to §421.7(d) reduces the certification time from 90 days (three months) to 30 days (one) month which reduces the deadline from the first day of the "ninth" month to the "seventh" month. The term "ninth" is deleted and "seventh" is inserted, also the following quarterly deadline months are replaced as follows: Quarter 1 - "December" is deleted and "October" is inserted; Quarter 2 - "March" is deleted and "January" is inserted; Quarter 3 - "June" is deleted and "April" is inserted; and Quarter 4 - "September" is deleted and "July" is inserted.

The amendment updates the title of §421.8 to Hospital Discharge Data Creation by deleting the word "Release" and adding the word "Creation." The language in §421.8(d)- (l) are deleted and moved to new §421.45, Data Requests and Releases. The language is modified to address the inpatient, outpatient and emergency department data set requests for public used data or research data files.

The amendments to the data element "Patient country" inserts the word "the" after "not in" and before "United States of America" to state "when address is not in the United States of America" in §421.8(c)(11)(HHHH), §421.9(d)(2)(F), §421.67(d)(2)(F), §421.67(e)(2)(F), existing §421.68(g)(10)(XXX) is renumbered as proposed §421.68(d)(10)(XXX), and existing §421.78(g)(10)(XXX) is renumbered as proposed §421.78(d)(10)(XXX).

In §421.8(c)(11)(A) - (IIII) and §421.9(d)(1) - (47), punctuation was added to the data elements list to be consistent with the rules in this subchapter.

The amendments to §421.9(a) delete the rule reference to "§421.5" and is replaced by new "§421.81" that references the modified language regarding health care facility exemption requirements. Section 421.5 is being repealed and moved to new §421.81.

The amendment to §421.9(c)(1) deletes the data element location language "2010BA or 2010CA in the segment DMG05 as a numeric value" for submission of patient race code and inserts the following phrase "2300 in the K3 segment" between "Loop" and "as." The word "a" is deleted and the phrase "the second" was added between "as" and "numeric" and the phrase "in this data segment" was added in the first sentence. The sentence states " Patient race - This data element shall be reported at Loop 2300 in the K3 segment as the second numeric value in this data segment." This moves the collection of the patient's code for their racial background code to the fixed length data segment "K3." The "K3" data segment is specifically for capturing State Required Data Elements.

The amendment to §421.9(c)(2) inserts the segment identifier "K3" between "the" and "segment." The segment identifier "NTE02" is deleted between the words "segment" and "as." Also, the word "a" is deleted and the phrase "the first" is inserted between the words "as" and "numeric." The sentence states "Patient ethnicity - This data element shall be reported at Loop 2300 in the K3 segment as the first numeric value." The K3 segment is the ANSI Accredited Standards Committee X12N, 837 Health Care Institutional Claim Implementation Guide (ANSI 837 Institutional Guide) standard reporting format location. This location is compliant with the HIPAA of 1996 and subsequent amendments and revision requirements which are outlined in Government Code, §531.0162 which establishes standard reporting guides for hospital inpatient claims.

The repeal of §421.10 deletes the Institutional Review Board language from this section and moves the rule to new §421.46.

The amendment to the title of Subchapter C of Chapter 421 deletes the phrase "Created by the Council" and adds the comma and phrase "Data Requests, and Data Fees" to state "Rules relating to Reports, Data Requests, and Data Fees. This amendment updates the rules of this subchapter and synchronizes language and requirements for data requests and the recoupment of funds for the program for collection and processing of data under Health and Safety Code, Chapter 108.

New §421.45, Data Requests and Releases, includes consolidated language regarding requests and release of "public used data" files and requests for "research data files" (which require the department's Institutional Review Board approval). The language is being moved from §421.8(d) - (l), §421.68(c) - (e) and (h) - (i), and §421.78(c) - (e) and (h) - (i) and consolidated in §421.45.

New §421.46 updates the Institutional Review Board language that was repealed from §421.10.

New §421.47, Data Fees, language is added to establish the fees for recoupment of funds to help sustain the program as mandated by the Health and Safety Code, §108.012(b) and SB 219 (84th Texas Legislature Regular Session).

The amendment to §421.61(17), definition of DSHS, deletes the term "Council" and inserts the phrase "Collection program." This amendment updates the rule in removing the previous agency name and synchronizes with the prior agency consolidation of HB 2292 (78th Texas Legislature) statutory language cleanup of SB 219 (84th Texas Legislature).

The amendment to §421.61(19) updates the definition of "Electronic Filing" and deletes the words "or other" between "diskette" and "magnetic" and inserts a comma after diskette. The text "or portable data storage" is inserted between "magnetic" and "media" to state "computer diskette, magnetic, or portable data storage media."

The amendment to §421.64(c) deletes the deletes the word "or" between "electronic" and "magnetic" from the first and second sentences and inserts a comma after "electronic." The following text "or portable data storage" is inserted between "magnetic" and "media."

The amendment to §421.64(c)(1)(A) inserts "Optical Media: Devices or disc that uses digital optical disc data storage format, for example Compact Disc (CD) or Digital Video Disc (DVD)." as the first sentence to update the technology. The word "computer" is deleted and replaced with "compact" before "disk (CD)."

The amendment to §421.64(c)(1)(B) inserts new language "Universal Serial Bus (USB) flash drive: portable data memory device using flash memory with a USB interface."

The amendment to §421.64(c)(1)(C) modifies language from §421.64(c)(1)(B) to address the new technologies. The first sentence deletes the word "or" between "electronic" and "magnetic" and inserts a comma after "electronic" and the text "or portable data storage" is inserted between "magnetic" and "media." The following new language is inserted as the second sentence "The department will not normally approve any medium which the department is not currently equipped to read."

The amendment to §421.64(c)(3) deletes the word "or" between "electronic" and "magnetic" from the first and second sentences and inserts a comma after "electronic." The text ", or portable data storage" is inserted between "magnetic" and "media."

The amendment to §421.64(d) removes the implementation date of July 1, 2009.

The amendment to §421.66(b) reduces the quarterly deadline dates by two months for corrections at the time of certification for the following quarters: for Quarter 1- "October" is deleted and "September" is inserted; for Quarter 2- "January" is deleted and "December" is inserted; for Quarter 3- "April" is deleted and "March" is inserted; and for Quarter 4- "July" is deleted and "June" is inserted.

The amendment to §421.66(d) reduces the certification time from 90 days (three months) to 30 days (one) month which reduces the deadline from the first day of the "ninth" month to "seventh" month. The term "ninth" is deleted and "seventh" is inserted. Also, the following quarterly deadline months are replaced as follows: (Quarter 1 - "December" is deleted and "October" is inserted; Quarter 2 - "March" is deleted and "January" is inserted; Quarter 3 - "June" is deleted and "April" is inserted; and Quarter 4 - "September" is deleted and "July" is inserted.

The amendment to §421.67(c)(1) deletes the data element location language "Loop 2010BA or 2010CA in the segment DMG05 as a numeric value" for submission of patient race code and inserts the following phrase "2300 in the K3 segment" after "Loop" and before "as." The phrase "the second" was added between "as" and "numeric." Also, in this sentence the phrase "in this data segment" is inserted after "value." The sentence states " Patient race - This data element shall be reported at Loop 2300 in the K3 segment as the second numeric value in this data segment." The K3 segment is the ANSI Accredited Standards Committee X12N, ANSI 837 Institutional Guide standard reporting format location. This location is compliant with the HIPAA and subsequent amendments and revision requirements which are outlined in Government Code, §531.0162, which establishes standard reporting guides for hospital inpatient, hospital and ambulatory surgical center, and hospital emergency department visit claims.

The amendment to §421.67(c)(2), deletes "NTE02" and inserts "K3" between "segment" and "as." The word "a" is deleted and the phrase "the first" is inserted between "as" and "numeric." The sentence states "Patient ethnicity - This data element shall be reported at Loop 2300 in the K3 segment as the first numeric value.

Section 421.68(c), (d), (e), (h) and (i) are deleted and the language concerning data requests and releases was moved to new §421.45. Subsections (f) and (g) are renumbered to (c) and (d).

The new language in new §421.69, Exemptions from Filing Requirements, directs the reader to new §421.81, Health Care Facilities Exemptions from Filing Requirements, which addresses exemption requirements for each of the three subchapters of claims data collection rules: §§421.1 - 421.10 - Collection And Release Of Hospital Discharge Data, §§421.61 - 421.69 Collection And Release Of Outpatient Surgical And Radiological Procedures At Hospitals And Ambulatory Surgical Centers and §§421.71 - 421.79 Collection And Release Of Hospital Outpatient Emergency Room Data.

The amendment to §421.71(14), definition of DSHS, deletes the term "Council" and inserts the phrase "Collection program." This amendment updates the rules in removing the previous agency name and synchronizes with the prior agency consolidation of HB 2292 (78th Texas Legislature) statutory language cleanup of SB 219 (84th Texas Legislature).

The amendment to §421.71(16) updates the definition of "Electronic Filing" and deletes the word "or other" between "diskette" and "magnetic" and inserts a comma after diskette. The following text, "or other portable data storage" is inserted between "magnetic" and "media." to state "computer diskette, magnetic, or portable data storage media."

In §421.78, subsections (c), (d), (e), (h) and (i) are deleted and the language concerning data requests and releases was moved to new §421.45. Subsections (f) and (g) are renumbered to (c) and (d).

The language in new §421.79, Exemptions from Filing Requirements directs the reader to new §421.81, Health Care Facilities Exemptions from Filing Requirements, which addresses exemption requirements for each of the three sets of subchapters of claims data collection rules: §§421.1 - 421.10 - Collection And Release Of Hospital Discharge Data; §§421.61 - 421.69 Collection And Release Of Outpatient Surgical And Radiological Procedures At Hospitals And Ambulatory Surgical Centers and §§421.71- 421.79 Collection And Release Of Hospital Outpatient Emergency Room Data.

New §421.81, Health Care Facilities Exemptions from Filing Requirements, adds language regarding requirements for health care facilities exemptions from filing discharge reports for §§421.1 - 421.9, 421.61 - 421.69 and 421.71 - 421.79.

FISCAL NOTE

Bruce Burns, Manager, THCIC, in the Center for Health Statistics has determined that for each year of the first five years that the sections will be in effect, there will be a fiscal impact of approximately $1,000 per facility to state or local governments (state owned hospitals and one ambulatory surgery center). The state cost is anticipated to be approximately $17,000 for the first year in 2017. Local government facility cost estimates were requested. The total cost estimates received were for one-time programming costs and ranged from zero dollars ($0) to approximately $2,000 per facility (facility would be for those state owned facilities or facilities owned by local governments). The costs are a result of enforcing and administering the sections as proposed. THCIC is rebidding the health care data collection system contract, which includes the proposed changes in the formatting; therefore, there are no additional costs to the department to comply with the propose rules.

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

Bruce Burns has also determined that there will be an adverse impact on small businesses or micro-businesses required to comply with the sections as proposed. This was determined by interpretation of the rules that small businesses and micro-businesses will be required to alter their business practices in order to comply with the sections.

THCIC staff requested cost estimates from facilities and their professional organizations regarding drafts of the proposed amendments, repeal of sections and new sections. In order for hospitals and ambulatory surgery centers to comply with moving the patient ethnicity and race code to the K3 segments and moving the patient social security number over, two (single digit code) characters will require programming changes to the information systems for the facilities/providers. The cost estimate anticipated is to be in the range of zero dollars ($0) to $2,000 (the average cost per facility of estimates received was $1,093). The cost will be dependent on the health care facilities information system, staffing or their contracted information system services. The facilities may require their claim data file to be mapped differently when being sent to THCIC's vendor under the ANSI approved format. The rules currently require the codes to be collected and reported, at this time, the providers only need to ensure the codes be reported in a different location than was previously required.

IMPACT ON LOCAL EMPLOYMENT

There is no anticipated negative impact on local employment.

PUBLIC BENEFIT

In addition, Bruce Burns has also determined that for each year of the first five years the sections are in effect, the public will benefit from adoption of the sections. The public benefit anticipated as a result of enforcing or administering the sections will be receiving data approximately two months earlier than the previously released, thus making the data more actionable for the recipients of the data.

REGULATORY ANALYSIS

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

TAKINGS IMPACT ASSESSMENT

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

PUBLIC COMMENT

Comments on the proposal may be submitted to Bruce Burns, Department of State Health Services, Mail Code 1898, P.O. Box 149347, Austin, Texas 78714-9347, or by email to bruce.burns@dshs.state.tx.us. Comments will be accepted for 30 days following publication of the proposal in the Texas Register.

PUBLIC HEARING

A public hearing to receive comments on the proposal is not scheduled. If THCIC staff receive numerous questions after publication in the Texas Register, THCIC staff will consult with executive leadership as to whether a public hearing ought to be scheduled. If a public hearing is to be scheduled, a meeting location, time and contact personnel will be posted in the Texas Register.

LEGAL CERTIFICATION

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

SUBCHAPTER A. COLLECTION AND RELEASE OF HOSPITAL DISCHARGE DATA

25 TAC §§421.1, 421.4, 421.6 - 421.9

STATUTORY AUTHORITY

The amendments are authorized by Health and Safety Code, §§108.006, 108.009, 108.010, 108.011 and 108.013, which require the Executive Commissioner to adopt rules necessary to carry out Chapter 108 including rules on data collection requirements, to prescribe the process of data submission, to implement a methodology to collect, 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 department 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 the department and for the administration of Health and Safety Code, Chapter 1001.

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

§421.1.Definitions.

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

(1) - (14) (No change.)

(15) 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 portable data storage [magnetic ] media acceptable to the executive director.

(16) - (25) (No change.)

(26) Institutional Review Board--The department's 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 as described in §421.46 [§421.10] of this title (relating to Institutional Review Board). The Institutional Review Board acts as the Scientific Review Panel described in the Health and Safety Code, §108.0135.

(27) - (37) (No change.)

(38) 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 the department, 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 §421.8 of this title (relating to Hospital Discharge Data Creation [Release]) are completed.

(39) - (48) (No change.)

§421.4.Instructions for Filing Discharge Reports.

(a) Portable Data Storage [Magnetic] Media. A discharge report may be filed on computer diskettes, USB flash drive, [nine track tapes] or other portable data storage [magnetic] 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) [Diskette]: MS-DOS formatted; PC Text file (ASCII) [; 3.5 inch diskette, 1.4 megabyte, high density].

(B) Universal Serial Bus (USB) flash drive: portable data memory device using flash memory with a USB interface. [Nine track tape: Density = 1600 or 6250 BPI, nine track; Collating sequence = EBCDIC; Labeling = IBM standard or facsimile.]

(C) Other electronic, magnetic or other portable data storage media: Discharge reports may be filed on other data storage [magnetic] 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 [(A) through (D)] for each hospital.

(4) In addition to the provisions of this section, the department shall document instructions for filing discharge reports on data storage [magnetic] 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 [magnetic] media. The department's instructions shall follow Department of Information Resources standards for data storage [magnetic] media established under 1 TAC Chapter 201.

(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 [§421.5] 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.

§421.6.Acceptance of Discharge Reports and Correction of Errors.

(a) - (c) (No change.)

(d) The department will document and the department will approve all acceptance and editing criteria utilized in reviewing discharge reports. If acceptance and editing criteria are incorporated into computer software, and if the software is the property of the department, the department will make copies of the portions of the software containing the criteria available on paper, [or] magnetic, or other portable data storage media. The department shall make this information available to submitters without charge and to others for the cost of reproduction.

(e) (No change.)

§421.7.Certification of Discharge Reports.

(a) (No change.)

(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 - September [October] 15; Quarter 2 - December [January] 15; Quarter 3 - March [April] 15; Quarter 4 - June [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 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) (No change.)

(d) Each hospital shall submit its certification form for each quarter's data to the department by the first day of the seventh [ninth] month (Quarter 1 - October [December ] 1; Quarter 2 - January [March] 1; Quarter 3 - April [June] 1; Quarter 4 - July [September] 1) 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) - (f) (No change.)

§421.8.Hospital Discharge Data Creation [Release].

(a) - (b) (No change.)

(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)(2) 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).

[(d) Release of public use data files. The department shall release public use data that has the identities masked relating to hospitals that are low volume providers to protect the confidentiality and privacy of the patients, physicians and other health professionals.]

[(e) The department will make available a public use data file on electronic, magnetic or optical media for each quarter:]

[(1) The department shall release public use data from hospitals that have certified the data as required by §421.7 of this title (relating to Certification of Discharge Reports). A hospital's failure to execute the certification form by the dates specified in §421.7(d) of this title, or elects to not certify the discharge encounter data shall not prevent the department from releasing the hospital's data if the department believes the data submitted is reasonably accurate and complete. The department may suppress for any quarter's data one or more data elements if deemed necessary to comply with provisions of the statutes. If an element is ordered suppressed by a judicial authority, the department may suppress the element.]

[(2) If additional discharge claims (not previously submitted as specified in §421.6(c)(4) of this title (relating to Acceptance of Discharge Reports and Correction of Errors), excluding replacement, adjustments and void/cancel discharge claims become available after the initial release of the public use data file for any quarter, the department will add the discharge claims, that are received on or prior to the date specified in §421.3(a)(1) of this title (relating to Schedule for Filing Discharge Reports) of the following quarter, to the public use data file and make the additional records available to the public.]

[(f) 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.]

[(g) The department 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).]

[(h) The data elements specified for discharge reports in §421.9 of this title (relating to Discharge Reports--Records, Data Fields and Codes) do not constitute "Provider Quality Data" as discussed in Health and Safety Code, §108.010.]

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

[(j) Requests for data files including data on one or more providers are matters of public record and copies of all requests shall be maintained by the department for two years from the date of receipt. The department shall make available on the department's Internet site and publish in the department's numbered letter for hospitals a summary of all requests received for public use data.]

[(k) With any public use data file prepared by the department, the department shall attach all comments submitted by providers, which relate to any data included in the file. The department shall also make these comments available at the department's offices and on the department's Internet site.]

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

[(1) the department's Hospital Discharge Data Research Data File Request Form is completed and submitted to the department; and]

[(2) the requestor has made payment according to the department's fee schedule. The department's fee includes a non-refundable "Review of Request Fee"; and]

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

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

[(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.]

§421.9.Discharge Reports--Records, Data Fields and Codes.

(a) Hospitals that have not obtained an exemption letter authorized by §421.81 [§421.5] of this title (relating to Health Care Facilities Exemptions from Filing Requirements) shall submit discharge reports, electronically in the file format for inpatient hospital bills defined by the American National Standards Institute (ANSI), commonly known as the ANSI ASC X12N form 837 Health Care Claims (ANSI 837 Institutional Guide) transaction for institutional claims and/or encounters. ANSI updates this format from time to time by issuing new versions.

(b) (No change.)

(c) In addition to the data elements contained in the ANSI 837 Institutional Guide, the department has defined the following data elements shown in this subsection and as defined the location in the ANSI 837 Institutional Guide where each element is to be reported. Data element content, format and locations may change as federal and state legislative requirements change in regards to Public Law 104-191, Health Insurance Portability and Accountability Act of 1996 (HIPAA), as amended, is implemented.

(1) Patient race - This data element shall be reported at Loop 2300 in the K3 segment [2010BA or 2010CA in the segment DMG05] as the second [a] numeric value in this data segment. 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 K3 segment [NTE02] as the first [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 nine (9)) 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 reported in Loop 2300 segment HI04-2).

(4) THCIC Identification Number - This data element shall be submitted in data segment REF02 of Loop 2010AA or Loop 2010AB (in the Pay-to provider reported provided the services), or Loop 2310E (if the Service Facility Provider is submitted).

(d) Hospitals shall submit the required minimum data set for all patients for which a discharge claim is required by this title. 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;

(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;

(F) Patient Country (if address is not in the 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 (Payer Source - primary and secondary (if applicable for secondary payer source);

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

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

(13) Type of Bill;

(14) Statement Dates (replaces Statement From and Statement Thru dates);

(15) Admission / Start of Care:

(A) Admission / Start of Care Date;

(B) Admission / Start of Care Hour;

(16) Admission Type;

(17) Admission Source;

(18) Patient (Discharge) Status;

(19) Patient Discharge Hour;

(20) Principal Diagnosis;

(21) Admitting Diagnosis;

(22) Principle External Cause of Injury (E-Code);

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

(24) External Cause Of Injury (E-Code) - up to 9 occurrences (if applicable);

(25) Principal Procedure Code (if applicable);

(26) Principal Procedure Date (if applicable);

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

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

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

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

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

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

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

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

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

(36) Attending Physician or Attending Practitioner Name:

(A) Attending Practitioner Last Name;

(B) Attending Practitioner First Name;

(C) Attending Practitioner Middle Initial;

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

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

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

(A) Operating Physician or Other Practitioner Last Name;

(B) Operating Physician or Other Practitioner First Name;

(C) Operating Physician or Other Practitioner Middle Initial;

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

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

(42) Total Claim Charges;

(43) 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;

(K) Non-covered Charge Amount;

(44) Service Provider Name;

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

(46) 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;

(E) Service Provider ZIP;

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

(e) - (f) (No change.)

The agency certifies that legal counsel has reviewed the proposal and found it to be within the state agency's legal authority to adopt.

Filed with the Office of the Secretary of State on March 20, 2017.

TRD-201701187

Lisa Hernandez

General Counsel

Department of State Health Services

Earliest possible date of adoption: April 30, 2017

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


25 TAC §421.5, §421.10

STATUTORY AUTHORITY

The repeals are authorized by Health and Safety Code, §§108.006, 108.009, 108.010, 108.011 and 108.013, which require the Executive Commissioner to adopt rules necessary to carry out Chapter 108 including rules on data collection requirements, to prescribe the process of data submission, to implement a methodology to collect, 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 department 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 the department and for the administration of Health and Safety Code, Chapter 1001.

The repeals affect Health and Safety Code, Chapters 108 and 1001; and Government Code, Chapter 531.

§421.5.Exemptions from Filing Requirements.

§421.10.Institutional Review Board.

The agency certifies that legal counsel has reviewed the proposal and found it to be within the state agency's legal authority to adopt.

Filed with the Office of the Secretary of State on March 20, 2017.

TRD-201701188

Lisa Hernandez

General Counsel

Department of State Health Services

Earliest possible date of adoption: April 30, 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

STATUTORY AUTHORITY

The new sections are authorized by Health and Safety Code, §§108.006, 108.009, 108.010, 108.011 and 108.013, which require the Executive Commissioner to adopt rules necessary to carry out Chapter 108 including rules on data collection requirements, to prescribe the process of data submission, to implement a methodology to collect, 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 department 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 the department and for the administration of Health and Safety Code, Chapter 1001.

The new sections affect Health and Safety Code, Chapters 108 and 1001; and Government Code, Chapter 531.

§421.45.Data Requests and Releases.

(a) Data Requests - General Information.

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

(2) Requests for data files including data on one or more providers are matters of public record and copies of all requests shall be maintained by the department for two years from the date of receipt. The department shall make available on the department's Internet site summary of all requests received for public use data.

(3) 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.

(4) The data elements specified for discharge reports in §421.9 of this title (relating to Discharge Reports--Records, Data Fields and Codes) or event files in §421.67 of this title (Event Files--Records, Data Fields and Codes) or §421.77 of this title (Event Files--Records, Data Fields and Codes) of this title do not constitute "Provider Quality Data" as discussed in Health and Safety Code, §108.010.

(b) Public Use Data File Requests and Releases.

(1) Release of public use data files. The department shall release public use data that has the identities masked relating to health care facilities that are low volume providers to protect the confidentiality and privacy of the patients, physicians and other health professionals.

(2) The department will make available a public use data file on electronic, magnetic or portable data storage media for each quarter as authorized by Health and Safety Code, Chapter 108 and by this section.

(3) The department shall release public use data from health care facilities that have certified the data as required by §421.7 of this (relating to Certification of Discharge Reports), or §421.66 (relating to Certification of Compiled Event Data) or §421.76 of this title (relating to Certification of Compiled Event Data) of this title. A health care facility's failure to execute the certification form by the dates specified in §421.7(d) or §421.66(d) or §421.76 of this title, or elects to not certify the discharge encounter data shall not prevent the department from releasing the hospital's data if the department believes the data submitted is reasonably accurate and complete. The department may suppress for any quarter's data one or more data elements if deemed necessary to comply with provisions of the statutes. If an element is ordered suppressed by a judicial authority, the department may suppress the element.

(4) If additional discharge claims (not previously submitted as specified in §421.6(c)(4) of this title (relating to Acceptance of Discharge Reports and Correction of Errors) or §421.65(b)(4) of this title (relating to Acceptance of Event Files and Correction of Data Content Errors) or §421.75 of this title (relating to Acceptance of Event Files and Correction of Data Content Errors) of this title, excluding replacement, adjustments and void/cancel discharge claims become available after the initial release of the public use data file for any quarter, the department will add the discharge claims, that are received on or prior to the date specified in §421.3(a)(1) of this title (relating to Schedule for Filing Discharge Reports) or §421.63(a)(1) - (4) of this title (relating to Schedule for Filing Event Files) or §421.73 of this title (relating to Schedule for Filing Event Files) of this title of the following quarter, to the public use data file and make the additional records available to the public.

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

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

(c) Research Data File Requests and Releases - A research data file may be released provided the following criteria are met:

(1) the department's Hospital Discharge Data Research Data File Request Form, or Outpatient Research Data File Request Form, or Emergency Department Research Data File Request Form is completed and submitted to the department;

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

(3) the Institutional Review Board and department's Executive Steering Committee grants authorization to the request or restricts access to specified data elements determined to be inappropriate for the research proposal in accordance with §421.46 of this title (relating to Institutional Review Board);

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

(5) the requestor has signed a written data release agreement; and

(6) the requestor has made payment according to §421.47 of this title (relating to Data Fees).

§421.46.Institutional Review Board.

(a) The department shall use the Institutional Review Board for the purposes of:

(1) evaluating applications for various measures or variables that are found in the department's hospital discharge data "research" file or outpatient surgical and radiological procedures at hospitals and ambulatory surgical centers "research" file or hospital outpatient emergency department data "research" file; and

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

(b) The Institutional Review Board functions relating to §421.45 of this title (relating to Data Requests and Release) and this section are abolished at such time as the department ceases to maintain a hospital discharge data "research" file or outpatient surgical and radiological procedures at hospitals and ambulatory surgical centers "research" file or hospital outpatient emergency department data "research" file.

(c) Meetings. Meetings of the Institutional Review Board shall be posted and conducted in accordance with the Texas Open Meetings Act, Government Code, Chapter 551.

(d) 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 the executive commissioner.

(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 the department in consultation with the executive commissioner when such waiver or reduction is in the department's interest.

(4) All requests for data must be submitted in writing, either on the form provided by the department 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).

(5) Only data elements requested by the requestor and approved for release by the Institutional Review Board, shall be included in the research file for release to the requestor in accordance with this chapter.

(e) Reports to the department. The Chair of the Institutional Review Board shall file with the Program Director a written report of all action taken relating to requests under this section at any meeting of the Institutional Review Board or of a Subcommittee within three working days of such meeting, including a detailed list of how each participating member voted.

§421.47.Data Fees.

(a) Public Use Data File Fees. Fees shall be charged for hospital inpatient data, outpatient data, and hospital emergency department data collected and created under Health and Safety Code, Chapter 108 and §421.8 of this title (relating to Hospital Discharge Data Creation), §421.67 of this title (relating to Event Files--Records, Data Fields and Codes) and §421.77 of this title (relating to Event Files--Records, Data Fields and Codes), respectively:

(1) State Agencies (including State owned universities) - $0.00.

(2) Texas City/County/Local Government Health Departments:

(A) Three most recent calendar years of data - $1,500.00;

(B) Calendar quarters for the three most recent calendar years - $438.00; or

(C) Calendar quarters that are four or more years than the current date - $156.25.

(3) Texas Reporting Hospitals, Texas In-State Media, and Out of State Health Departments:

(A) Three most recent calendar years of data - $3,000.00;

(B) Calendar quarters for the three most recent calendar years - $875.00; or

(C) Calendar quarters that are four or more years than the current date - $312.50.

(4) Texas private universities/colleges, out of state universities, out of state media, out of state agencies, out of state hospitals and all other businesses or consumers, including hospital or ambulatory surgery center affiliates, organizations, institutions and corporate offices:

(A) Three most recent calendar years of data - $6,000.00;

(B) Calendar quarters for the three most recent calendar years - $1,750.00; or

(C) Calendar quarters that are four or more years than the current date - $625.00.

(5) Multiple site location organizations:

(A) Two to four license locations:

(i) Three most recent calendar years of data - $9,000.00;

(ii) Calendar quarters for the three most recent calendar years - $2,750.00; or

(iii) Calendar quarters that are four or more years than the current date - $982.00.

(B) Five to nine license locations:

(i) Three most recent calendar years of data - $12,000.00;

(ii) Calendar quarters for the three most recent calendar years - $4,000.00; or

(iii) Calendar quarters that are four or more years than the current date - $1429.00.

(C) Ten or more license locations:

(i) Three most recent calendar years of data - $15,000.00;

(ii) Calendar quarters for the three most recent calendar years - $5,250.00; or

(iii) Calendar quarters that are four or more years than the current date - $1875.00.

(b) Research Data File Fees. Research data file requests require Institutional Review Board approval in §421.46 of this title (relating to Institutional Review Board).

(1) State Agencies:

(A) Health and Human Services Agencies - $0.00.

(B) Texas State Agencies (other than Health and Human Services Agencies) and Texas State universities - Refer to paragraph (3) of this subsection.

(2) All other requestors - Refer to paragraph (3) of this subsection.

(3) Research Data File Fee Structure - All Institutional Review Board approved Research Data Files are custom built and may incur one or more of the following charges dependent on the approved request.

(A) Base fee - Approved Institutional Review Board research data file requests that require no additional work to prepare the data (For example, filtering or linking) the fee shall be $30 per data element per calendar quarter;

(B) Fee for identifying and extracting Institutional Review Board approved data according to the specific criteria noted on the Institutional Review Board documentation and in consultation with the requestor. The data shall be extracted from the complete dataset of requested data noted in the Institutional Review Board documentation. The fee will be dependent on the amount of labor determined by the department program staff performing the service to prepare, process and verify the Institutional Review Board approved data for the requestor, times the hourly midpoint range rate of the Salary Group for Class Title "Research Specialist IV" determined by the State Auditor's Office. This fee shall be added to the fee noted in subparagraph (A) of this paragraph and if applicable, subparagraph (C) of this paragraph; or

(C) Fee for linking of approved research data file requests with other datasets: The fee will be dependent on the amount time of labor determined by the department program staff performing the service to prepare, process and verify the Institutional Review Board approved data for the requestor, times the hourly midpoint range rate of the Salary Group for Class Title "Research Specialist IV" determined by the State Auditor's Office.

The agency certifies that legal counsel has reviewed the proposal and found it to be within the state agency's legal authority to adopt.

Filed with the Office of the Secretary of State on March 20, 2017.

TRD-201701189

Lisa Hernandez

General Counsel

Department of State Health Services

Earliest possible date of adoption: April 30, 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

STATUTORY AUTHORITY

The amendments and new section are authorized by Health and Safety Code, §§108.006, 108.009, 108.010, 108.011 and 108.013, which require the Executive Commissioner to adopt rules necessary to carry out Chapter 108 including rules on data collection requirements, to prescribe the process of data submission, to implement a methodology to collect, 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 department 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 the department and for the administration of Health and Safety Code, Chapter 1001.

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

§421.61.Definitions.

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

(1) - (16) (No change.)

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

(18) (No change.)

(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, or portable data storage media acceptable to DSHS.

(20) - (54) (No change.)

§421.64.Instructions for Filing Event Files.

(a) - (b) (No change.)

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

(1) Media specifications are:

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

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

(C) [(B)] other electronic, [or] magnetic or other portable data storage media only with the prior written approval from the department. The department will not normally approve any medium which the department is not currently equipped to read.

(2) (No change.)

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

(d) This section is effective 90 calendar days after being published in the Texas Register. [The department will not implement or enforce this section until July 1, 2009, at the earliest.]

§421.66.Certification of Compiled Event Data.

(a) (No change.)

(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 - September [October] 15; Quarter 2 - December [January] 15; Quarter 3 - March [April] 15; Quarter 4 - June [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) (No change.)

(d) Each facility shall submit its certification form for each quarter's data to DSHS by the first day of the seventh [ninth] month (Quarter 1- October [December] 1; Quarter 2- January [March] 1; Quarter 3 - April [June] 1; Quarter 4 - July [September] 1) 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) - (f) (No change.)

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

(a) - (b) (No change.)

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

(1) Patient race - This data element shall be reported at Loop 2300 in the K3 segment [2010BA or 2010CA in the segment DMG05] as the second [a] numeric value in this data segment. Acceptable codes are 1 = American Indian/Eskimo/Aleut, 2 = Asian or, Pacific Islander, 3 = Black, 4 = White and 5 = Other Race. In order to obtain this data, the facility staff retrieves the patient's response from a written form or asks the patient, or the person speaking for the patient to classify the patient. If the patient, or person speaking for the patient, declines to answer, the facility 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 K3 [NTE02] as the first [a] numeric value. Acceptable codes are 1 = Hispanic or Latino Origin and 2 = Not of Hispanic or Latino Origin. In order to obtain this data, the facility staff retrieves the patient's response from a written form or asks the patient, or the person speaking for the patient to classify the patient. If the patient, or person speaking for the patient, declines to answer, the facility staff is to use its best judgment to make the correct classification based on available data.

(3) - (4) (No change.)

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

(1) (No change.)

(2) Patient Address:

(A) - (E) (No change.)

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

(3) - (39) (No change.)

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

(1) (No change.)

(2) Patient Address.

(A) - (E) (No change.)

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

(3) - (26) (No change.)

(f) - (g) (No change.)

(h) This section is effective 90 calendar days after being published in the Texas Register.

§421.68.Event Data Release.

(a) (No change.)

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

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

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

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

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

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

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

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

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

(2) convert patient birth date to age;

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

(4) convert occurrence dates to day values;

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

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

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

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

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

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

(A) Event Year and Quarter;

(B) Provider Name (Facility Name);

(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).

[(h) Release of public use data files.]

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

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

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

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

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

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

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

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

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

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

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

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

§421.69.Exemptions from Filing Requirements.

Refer to §421.81 of this title (relating to Health Care Facilities Exemptions from Filing Requirements) for exemptions from filing discharge reports.

The agency certifies that legal counsel has reviewed the proposal and found it to be within the state agency's legal authority to adopt.

Filed with the Office of the Secretary of State on March 20, 2017.

TRD-201701190

Lisa Hernandez

General Counsel

Department of State Health Services

Earliest possible date of adoption: April 30, 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

STATUTORY AUTHORITY

The amendments and new section are authorized by Health and Safety Code, §§108.006, 108.009, 108.010, 108.011 and 108.013, which require the Executive Commissioner to adopt rules necessary to carry out Chapter 108 including rules on data collection requirements, to prescribe the process of data submission, to implement a methodology to collect, 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 department 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 the department and for the administration of Health and Safety Code, Chapter 1001.

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

§421.71.Definitions.

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

(1) - (13) (No change.)

(14) DSHS--Department of State Health Services, the successor state agency to the Texas Health Care Information Collection program [Council] and the Texas Department of Health.

(15) (No change.)

(16) 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, or other portable data storage media acceptable to DSHS.

(17) - (50) (No change.)

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

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

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

(c) [(f)] 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) [(g)] 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)(2), shall be five, unless DSHS determines that a higher cell size is required to protect the confidentiality of an individual patient or physician;

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

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

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

(A) Event Year and Quarter;

(B) Provider Name (Facility Name);

(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).

[(h) Release of public use data files.]

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

[(2) DSHS shall release public use data from facilities that have certified the data as required by §421.76 of this title (relating to Certification of Compiled Event Data). A facility's failure to execute the certification form by the dates specified in 25 TAC §421.66(d) of this title (relating to Certification of Compiled Event Data), or election to not certify the discharge encounter data shall not prevent DSHS from releasing the facility's data if DSHS believes the data submitted is reasonably accurate and complete. DSHS may suppress for any quarter's data one or more data elements if deemed necessary to comply with provisions of the statute.]

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

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

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

[(i) An outpatient emergency visit event research data file may be released provided the following criteria are met:]

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

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

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

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

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

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

§421.79.Exemptions from Filing Requirements.

Refer to §421.81 of this title (relating to Health Care Facilities Exemptions from Filing Requirements) for exemptions from filing discharge reports.

The agency certifies that legal counsel has reviewed the proposal and found it to be within the state agency's legal authority to adopt.

Filed with the Office of the Secretary of State on March 20, 2017.

TRD-201701191

Lisa Hernandez

General Counsel

Department of State Health Services

Earliest possible date of adoption: April 30, 2017

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


SUBCHAPTER F. HEALTH CARE FACILITY EXEMPTIONS

25 TAC §421.81

STATUTORY AUTHORITY

The new section is authorized by Health and Safety Code, §§108.006, 108.009, 108.010, 108.011 and 108.013, which require the Executive Commissioner to adopt rules necessary to carry out Chapter 108 including rules on data collection requirements, to prescribe the process of data submission, to implement a methodology to collect, 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 department 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 the department and for the administration of Health and Safety Code, Chapter 1001.

The new section affects Health and Safety Code, Chapters 108 and 1001; and Government Code, Chapter 531.

§421.81.Health Care Facilities Exemptions from Filing Requirements.

(a) Types of Exemptions.

(1) Exemption as an exempted provider. All health care facilities except those owned by the federal government shall submit discharge reports to the department unless the department determines that the hospital shall be considered an exempted provider. The department shall make a determination of which health care facilities are entitled to this exemption and shall notify hospitals by email or by regular United States mail. This exemption, if granted, may be revoked by the department should the hospital cease to meet the criteria for exemption. Health care facilities that cease to be exempted as an exempted provider shall be responsible for submitting discharge claims on all discharges that occur 30 days after loss of the exemption. The initial discharge report shall not be due until 90 days after notice is given. Subsequent discharge reports are due as specified in §421.3(a) of this title (relating to Schedule for Filing Discharge Reports).

(2) Exemptions from Quarterly Filing of Discharge Reports. Health care facilities that wish to submit discharge reports to the department more often than quarterly may do so by requesting an exemption to the standard submission schedule. The department may also issue general exemptions based on the processing arrangements for data collection. Exemption requests meeting the following criteria as shown in subparagraphs (A) - (D) of this paragraph will normally be approved.

(A) The exemption request includes the specific schedule on which the health care facility will make its discharge reports, which will usually be daily, weekly or monthly.

(B) The exemption request states the medium in which submissions will be made.

(C) The exemption request will not result in data on any discharge being submitted to the department at a later date than it would have been if the standard schedule had been followed.

(D) The health care facility agrees to adhere to the schedule specified in the exemption request until the health care facility notifies the department in writing that it wishes to end the exemption and report according to the standard schedule, or until a new exemption letter is issued.

(b) Requests for exemptions shall be submitted and processed using the following procedures as shown in paragraphs (1) - (4) of this subsection.

(1) A health care facility requesting an exemption shall submit to the department a letter requesting the exemption and providing all information necessary to establish the hospital's entitlement to the exemption. The exemption request shall be signed by the chief executive officer of the hospital who shall certify that all information contained in the request is true and correct.

(2) The department shall review the request for exemption. The department may request additional information from the health care facility relevant to the exemption request. Within 30 days of receipt of a request, the department shall issue a letter granting or denying the exemption. If denied, the letter shall state in detail the reasons for the denial.

(3) If the department denies an exemption request the health care facility may:

(A) resubmit the request along with any additional information or analysis the health care facility deems relevant to the department. The resubmission shall be considered in the same manner as an initial submission; or

(B) appeal the department's decision to the commissioner of the department. The health care facility may make an appeal directly to the commissioner of the department. In making its determination, the department will consider only those facts and issues which have been previously presented to the department.

(4) The department may revoke any type of exemption if facts indicate that a health care facility no longer meets the criteria required for an exemption. The department shall give the health care facility written notice of the revocation at least 30 days prior to the effective date of the revocation. The notice shall include a detailed statement of the facts on which the revocation is based. A health care facility may challenge the revocation of its exemption by:

(A) requesting the department to reconsider the revocation by submitting any information or analysis the health care facility deems relevant to the department in writing at least ten days prior to the effective date of the revocation; and

(B) by appealing to the commissioner of the department if the department does not grant the request for reconsideration. In making its determination, the commissioner of the department will consider only those facts and issues which have been previously presented to the department.

(c) Reporting loss of exemptions. Health care facilities shall notify the department in writing within 30 days of their loss of an exemption authorized by subsection (a) of this section.

The agency certifies that legal counsel has reviewed the proposal and found it to be within the state agency's legal authority to adopt.

Filed with the Office of the Secretary of State on March 20, 2017.

TRD-201701192

Lisa Hernandez

General Counsel

Department of State Health Services

Earliest possible date of adoption: April 30, 2017

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