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Texas
Laws Affecting HIM Professionals  |
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Title 25, Health Services
Proposed Preamble
The Texas Department of Health (department) proposes amendments of §§91.1, 91.4, 91.6, 91.7, the repeal of §§91.2, 91.3, 91.5, 91.8 - 91.14 and new §§91.2, 91.3, 91.5, 91.8 - 91.12 concerning the cancer registry and the reporting of cancer incidence data to the department or its authorized representatives. The amended and new sections specify who is required to report and has access to records for reporting; what cancer information is to be reported; when, how and where this information should be reported; a definition of reporting compliance and a cost-recovery method to access cancer information from persons failing to report in the prescribed format; quality assurance activities; confidentiality and disclosure of cancer information; and requests for and release of statistical and personal cancer data.
Specifically, these amendments, repeals, and new sections are required by Chapter 82, Texas Health and Safety Code which was revised by Senate Bill 285, 77th Legislature, 2001, to include cancer reporting by health care practitioners and to clarify and improve cancer incidence reporting. These changes also are needed to fulfill federal grant requirements for Texas to maintain a statewide population-based cancer registry that meets national standards. State law and regulations must support the National Program of Cancer Registries’ requirements (42 U.S.C. §§280e to 280e-4) for receipt of federal funding.
New §91.3 reflects the expanded scope of the law for cancer reporting to include health care practitioners (physicians and dentists). New §§91.3 and 91.9 address cancer case reporting and data disclosure under the Health Insurance Portability and Accountability Act of 1996 and the Texas Health and Safety Code, Chapter 181, Medical Records Privacy. An amendment to §91.4 reflects changes in the reportable conditions and information and requires electronic reporting with one exception. New §91.5 outlines reporting timeframes and frequency of reporting for health care facilities, health care practitioners and clinical laboratories. New §91.12 reflects a new approval process for release of personal cancer data.
Nancy S. Weiss, Ph.D., Director, Cancer Registry Division has determined that for the first five-year period the sections are in effect, there will be fiscal implications as a result of enforcing or administering the sections as proposed. These sections are necessary for the department to continue to receive federal grant funds. For FY 2002, those funds are $2.1 million. The amounts for subsequent years have not yet been determined. It is estimated that costs to the state to administer the new data collection method will be offset by the federal funds received. There will be no fiscal implications for most local governments. Local governments that are providing cancer diagnosis and/or treatment will incur costs of $8 to $15 per case.
Dr. Weiss has also determined that for each year of the first five years the sections are in effect, the public benefit anticipated as a result of enforcing the sections will be to have complete and accurate cancer data reported within six months of initial diagnosis or admission for the diagnosis or treatment of cancer. This will increase the availability of timely, statewide cancer incidence data for use in cancer prevention and control efforts in the state and for securing cancer research funding. The anticipated effect on micro-businesses or small businesses (as well as large businesses) that do not report will be the cost of data collection by the department estimated to be $35 to $65 per unreported cancer case. The economic costs to persons who are required to comply with the sections as proposed will be the staff time to complete reporting requirements which is estimated to be 15 to 45 minutes per case (estimated $8 to $15 per case). There will be no impact on local employment.
Government Code, §2001.039 requires that each state agency review and consider for readoption each rule adopted by that agency pursuant to the Government Code, Chapter 2001 (Administrative Procedure Act). The department has reviewed §§91.1 - 91.14 and has determined that reasons for adopting the sections continue to exist; however §§91.1, 91.4, 91.6, and 91.7 are being amended, and proposed new §§91.2, 91.3, 91.5, 91.8 - 91.12 are necessary as described in this preamble. Sections 91.2, 91.3, 91.5, 91.8 - 91.14 have been reviewed and the department has determined that the reasons for adopting these sections no longer continue to exist and the rules will be repealed.
The department published a Notice of Intention to Review for §§91.1 - 91.14 in the Texas Register on January 7, 2000 (25 TexReg 218). No comments were received due to publication of this notice.
Comments on the proposal may be submitted to Nancy S. Weiss, Ph.D., Director, Cancer Registry Division, Texas Department of Health, 1100 West 49th Street, Austin, Texas, 78756, (512) 458-7523. Comments will be accepted for 30 days following publication of this proposal in the Texas Register.
The amendments, repeals, and new sections are proposed under Health and Safety Code §82.006 which provides the department with the authority to adopt rules necessary to implement Chapter 82 (Cancer Registry); §81.004 which provides the Texas Board of Health with the authority to administer Chapter 81 for protecting the public’s health and preventing the introduction of disease in the state; and §12.001, which provides the Texas Board of Health with the authority to adopt rules for the performance of every duty imposed by law on the board, the department, and the commissioner of health.
The amendments, repeals, and new sections affect Health and Safety Code, Chapter 82.
Sections for Repeal.
§91.2. Definitions. §91.3. Who Reports. §91.5. When To Report. §91.8. Compliance. §91.9. Immunity from Liability. §91.10. Confidentiality and Disclosure. §91.11. Quality Assurance. §91.12. Requests for Statistical Cancer Data. §91.13. Requests and Release of Personal Cancer Data. §91.14. Statistical Reports.
Legend: (Proposed Amendments) Single Underline = Proposed new language [Bold Print and Brackets] = Current language proposed for deletion Regular Print = Current language (No change.) = No changes are being considered for the designated subdivision
Legend: (Proposed New Rule) Regular Print = Proposed new language
§91.1. Purpose. (Amendment)
These sections implement the Texas Cancer Incidence Reporting Act, Health and Safety Code, Chapter 82, which authorizes the Texas Board of Health to adopt rules concerning the reporting of cases [of precancerous and tumorous diseases and] cancer for the recognition, prevention, cure, or control of those diseases, and to facilitate participation in the national program of cancer registries established by 42 United States Code §§280e to 280e-4. Nothing in these sections shall preempt the authority of facilities or individuals providing diagnostic or treatment services to patients with cancer to maintain their own cancer [facility based tumor] registries.
§91.2. Definitions. (New)
The following words and terms, when used in these sections, shall have the following meanings, unless the context clearly indicates otherwise.
(1) Act – The Texas Cancer Incidence Reporting Act, Texas Health and Safety Code, Chapter 82.
(2) Cancer - Includes a large group of diseases characterized by uncontrolled growth and spread of abnormal cells; any condition of tumors having the properties of anaplasia, invasion, and metastasis; a cellular tumor the natural course of which is fatal, including malignant and benign tumors of the central nervous system; and malignant neoplasm, other than nonmelanoma skin cancers such as basal and squamous cell carcinomas.
(3) Cancer reporting handbook - The division’s manual for cancer reporters that documents reporting procedures and format.
(4) Clinical laboratory - An accredited facility in which tests are performed identifying findings of anatomical changes; specimens are interpreted and pathological diagnoses are made.
(5) Department - Texas Department of Health.
(6) Division - Cancer Registry Division of the department.
(7) Health care facility – A general or special hospital as defined by the Health and Safety Code, Chapter 241; an ambulatory surgical center licensed under the Health and Safety Code, Chapter 243; an institution licensed under the Health and Safety Code, Chapter 242; or any other facility, including an outpatient clinic, that provides diagnostic or treatment services to patients with cancer.
(8) Health care practitioner – A physician as defined by Occupations Code, §151.002 or a person who practices dentistry as described by the Occupations Code, §251.003.
(9) Personal cancer data - Information that includes items that may identify an individual.
(10) Quality assurance - Operational procedures by which the accuracy, completeness, and timeliness of the information reported to the department can be determined and verified.
(11) Regional cancer registry - The organization authorized by the department to receive and collect cancer data for a designated area of the state and which maintains the system by which the collected information is reported to the department.
(12) Regional director - The physician who is the chief administrative officer of a public health region and is designated by the department under the Local Public Health Reorganization Act, Health and Safety Code, §121.007.
(13) Report - Information provided to the department that notifies the appropriate authority of the occupancy of a specific cancer in a person, including all information required to be provided to the department.
(14) Research – A systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.
(15) Statistical data - Aggregate presentation of individual records on cancer cases excluding patient identifying information.
(16) Texas Cancer Registry - The cancer incidence reporting system administered by the Cancer Registry Division.
§91.3. Who Reports, Access to Records. (New)
(a) Each health care facility, clinical laboratory or health care practitioner shall report to the department, by methods specified in §§91.4-91.7 of this title (relating to Cancer Registry), required data from each medical record pertaining to a case of cancer in its custody or under its control except for cases to which subsection (d) of this section would apply.
(b) A health care facility or clinical laboratory providing screening, diagnostic or therapeutic services to patients with cancer shall grant the department or its authorized representative access to but not removal of all medical records which would identify cases of cancer, establish characteristics or treatment of cancer, or determine the medical status of any identified cancer patient.
(c) A health care practitioner providing diagnostic or treatment services to patients with cancer shall grant the department or its authorized representative access to but not removal of all medical records which would identify cases of cancer, establish characteristics or treatment of cancer, or determine the medical status of any identified cancer patient except for cases to which subsection (d) of this section would apply.
(d) The department may not require a health care practitioner to furnish data or provide access to records if:
(1) the data or records pertain to cases reported by a health care facility providing screening, diagnostic, or therapeutic services to cancer patients that involve patients referred directly to or previously admitted to the facility; and
(2) the facility reported the same data the practitioner would be required to report.
(e) Health care facilities, clinical laboratories, and health care practitioners are subject to federal law known as the Health Insurance Portability and Accountability Act of 1996 found at Title 42 United States Code §1320d et seq.; the federal privacy rules adopted in Title 45 Code of Federal Regulations (C.F.R.) Parts 160 and 164; and state law found in the Health and Safety Code, Chapter 181, Medical Records Privacy, §181.101. Because state law requires reporting of cancer data, persons subject to this chapter are permitted to provide the data to the department without patient consent or authorization under 45 C.F.R. §164.512(a) relating to uses and disclosures required by law and §164.512(b)(1) relating to disclosures for public health activities. Both of these exceptions to patient consent or authorization are recognized in the state law in Health and Safety Code, §181.101.
§91.4. What to Report. (Amendment)
(a) Reportable conditions.
(1) The cases [Cases] of cancer [or those precancerous or tumorous diseases] to be reported to the division are as follows:
(A) all neoplasms with a behavior code of two or three in the most current edition of the International Classification on Diseases for Oncology (ICD-O) of the World Health Organization with the exception of those designated by the division as non-reportable in the cancer reporting handbook; and
(B) all benign and borderline neoplasms of the [brain and] central nervous system[;].
[(C) cystadenomas of borderline malignancy of ovary (ICDO-2 codes C56.9 and M83801);]
[(D) hydatiform mole, malignant (ICDO-2 codes C58.9 and M91001); and]
[(E) any neoplasm specified malignant.]
(2) Codes and taxa of the most current edition of the International Classification of Diseases, [Ninth Revision,] Clinical Modification of the World Health Organization which correspond to the division’s reportable list are specified in the cancer reporting handbook.
(b) Reportable information.
(1) The data required to be reported [produced or furnished] shall include, but not be limited to:
(A) (No change.)
(B) social security number, date of birth, gender [sex], race and [Spanish] ethnicity, marital status, and birthplace, to the extent such information is available from the medical record;
(C) (No change.)
(D) diagnosis including the cancer site and laterality, cell type, tumor behavior, grade and size, stage of disease, date of diagnosis, and diagnostic confirmation method;
(E) (No change.)
(F) text information to support cancer diagnosis, stage and treatment codes, unless another method acceptable to the division is used to confirm these codes.[to be provided by facilities without a documented data quality program such as one approved by the American College of Surgeons.]
(2) Each report shall:
(A) be legible and contain all data items required in paragraph (b)(1) of this section [relating to reporting requirements and complete documentation];
(B) – (C) (No change.)
(D) in the case of individuals who have more than one form of cancer, be submitted separately for each primary cancer [or precancerous or tumorous disease] diagnosed;
(E) be submitted to the division electronically, or manually if electronic means are unavailable; and the annual cancer caseload of the health care facility, clinical laboratory or health care practitioner is 50 or fewer cases; and
(F) (No change.)
§91.5. When to Report. (New)
(a) All reports shall be submitted to the department within six months of the patient’s admission, initial diagnosis or treatment for cancer.
(b) Data shall be submitted no less than quarterly by health care facilities with annual caseloads of 400 or less. Monthly submissions are required for all other health care facilities.
(c) Data shall be submitted no less than quarterly by health care practitioners initially diagnosing a patient with cancer and performing the in-house pathological tests for that patient. Otherwise, data shall be submitted within 4 months of the request to a health care practitioner by the department or its authorized representative for a report or subset of a report on a patient diagnosed or treated elsewhere and for whom the same cancer data has not been reported.
(d) Data shall be submitted no less than bi-annually by clinical laboratories.
§91.6. How to Report. (Amendment)
A report of cancer can be made to the department by any of the following methods:
(1) submission of an original of a completed Confidential Cancer Reporting Form (TCR No.1)[;] if electronic means are unavailable and the annual cancer caseload of the health care facility, clinical laboratory or health care practitioner is 50 or fewer cases; or
(2) submission electronically of a TCR No. 1 or a subset of data items acceptable to the division using one of the following methods:
(A) (No change.)
(B) compact disc [magnetic tape];
(C) – (D) (No change.)
§91.7. Where to Report. (Amendment)
(a) Forms.
[(1)] All counties shall be assigned by the division to a [designated] regional cancer registry. [of a public health region.] Completed forms shall be submitted to the regional director or his designee at the regional cancer registry [public health region] designated to receive data from the county where the person with cancer [or precancerous or tumorous disease] is admitted, diagnosed or treated.
[(2) A map and list of public health regions, and the addresses of respective regional directors are available from the Texas Department of Health, 1100 West 49th Street, Austin, Texas, 78756-3199.]
(b) All electronic data reports should be submitted to the division as specified in the cancer reporting handbook. [central office of the division to the Cancer Registry Division, Texas Department of Health, 1100 West 49th Street, Austin, Texas 78756-3199.]
§91.8. Compliance. (New)
(a) Each health care facility, clinical laboratory or health care practitioner that reports to the department, by methods specified in §§91.4-91.7 of this title (relating to Cancer Registry), is considered compliant.
(b) A person will be notified in writing if the person has not reported in compliance with this chapter within 30 days following the end of the calendar year quarter and will be given an opportunity to take corrective action within 60 days from the date of the notification letter. A second notification letter will be sent 30 days after the date of the original notification letter if no corrective action has been taken.
(c) If a person is non-compliant and takes no corrective action within 60 days of the original notification letter, the department or its authorized representative may access the information from the health care facility, clinical laboratory or health care practitioner as provided in §91.3 of this title (relating to Who Reports, Access to Records) and report it in the appropriate format. (1) The health care facility, clinical laboratory or health care practitioner shall be notified at least two weeks in advance before a scheduled arrival for collection of the information. (2) A health care facility, clinical laboratory or health care practitioner that knowingly or in bad faith fails to furnish data as required by this chapter shall reimburse the department or its authorized representative for its cost to access and report the information. The costs must be reasonable, based on the actual costs incurred by the department or by its authorized representative in the collection of the data and may include salary and travel expenses. It is presumed that a health care facility, clinical laboratory or health care practitioner acted knowingly or in bad faith if it failed to take corrective action within 60 days of the date of the original notification letter. (3) A health care facility, clinical laboratory or health care practitioner may request the department to conduct a hearing under the department’s fair hearing rules to determine whether reimbursement to the department is appropriate.
(d) Any health care facility, clinical laboratory or health care practitioner which is required to reimburse the department or its authorized representative for the cost to access and report the information pursuant to subsection (c)(2) of this section shall provide payment to the department or its authorized representative within 60 days of the day this payment is demanded. In the event any health care facility, clinical laboratory or health care practitioner fails to make payment to the department or its authorized representative within 60 days of the day the payment is demanded, the department or its authorized representative may, at its discretion, assess a late fee not to exceed 1-1/2 % per month of the outstanding balance.
§91.9. Confidentiality and Disclosure. (New)
(a) Pursuant to the Act, Chapter 82, 82.009, all data obtained is for the confidential use of the department and the persons or public or private entities that the department determines are necessary to carry out the intent of the Act.
(b) Limited release of the data is allowed by the Act, §§82.008(h) and 82.009(b).
(c) Any requests for confidential or statistical data shall be made in accordance with §§91.11 or 91.12 of this title (relating to Cancer Registry).
(d) The Texas Cancer Registry is subject to the Health and Safety Code, Chapter 181, Medical Records Privacy, §181.101 that requires compliance with portions of the federal law and regulations cited in §91.3(e) of this title (relating to Who Reports, Access to Records). The department is authorized to use and disclose, for purposes described in the Act, cancer data without patient consent or authorization under 45 C.F.R §164.512(a) relating to uses and disclosures required by law, §164.512(b)(1) and (2) relating to uses and disclosures for publish health activities, and §164.512(i) relating to uses and disclosures for research purposes.
§91.10. Quality Assurance. (New)
The department shall cooperate and consult with persons required to comply with this chapter so that such persons may provide timely, complete and accurate data. The department will provide:
(1) reporting training, on-site case-finding studies, and reabstracting studies;
(2) quality assessment reports to ascertain that the computerized data utilized for statistical information and data compilation is accurate; and
(3) educational information on cancer morbidity and mortality statistics available from the Texas Cancer Registry and the department.
§91.11. Requests for Statistical Cancer Data. (New)
(a) Statistical cancer data previously analyzed and printed are available upon written or oral request to the division. All other requests for statistical data shall be in writing and directed to: Cancer Registry Division, Texas Department of Health, 1100 West 49th Street, Austin Texas 78756-3199.
(b) To ensure that the proper data are provided, the request shall include, but not be limited to, the following information:
(1) name, address, and telephone number of the person requesting the information;
(2) type of data needed and for what years (e.g. lung cancer incidence rates, Brewster County, 1992-1995); and
(3) name and address of person(s) to who data and billings are to be sent (if applicable).
§91.12. Requests and Release of Personal Cancer Data. (New)
(a) Data requests for research.
(1) Requests for personal cancer data shall be in writing and directed to: Texas Department of Health, Institutional Review Board (IRB), 1100 West 49th Street, Austin, Texas 78756-3199.
(2) Written requests for personal data shall meet the submission requirements of the department’s IRB before release.
(3) The division may release personal cancer data to state, federal, local, and other public agencies and organizations if approved by the IRB.
(4) The division may release personal cancer data to private agencies, organizations, and associations if approved by the IRB.
(5) The division may release personal cancer data to any other individual or entities for reasons deemed necessary by the department to carry out the intent of the Act if approved by the IRB.
(b) Data requests for non-research purposes.
(1) The division may provide reports containing personal data back to the respective reporting entity from records previously submitted to the division from each respective reporting entity for the purposes of case management and administrative studies. These reports will not be released to any other entity.
(2) The division may release personal data to other bureaus of the department, provided that the disclosure is required or authorized by law. All communications of this nature shall be clearly labeled “Confidential” and will follow established departmental internal protocols and procedures.
(3) The division may release personal data to the department’s Cancer Registry Program personnel headquartered in public health regions or public health departments to facilitate the collection, editing, and analysis of cancer registry data for the respective geographic area. All communications of this nature shall be clearly labeled “Confidential” and will follow established departmental internal protocols and procedures.
(4) The division may release personal cancer data to state, federal, local, and other public agencies and organizations in accordance with subsection (a) of this section.
(5) The division may release personal cancer data to any other individual or entities for reasons deemed necessary by the board to carry out the intent of the Act and in accordance with subsection (a) of this section.
(6) A person who submits a valid authorization for release of an individual cancer record shall have access to review or obtain copies of the information described in the authorization for release. |
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