TITLE 25.HEALTH SERVICES

Part 1. TEXAS DEPARTMENT OF HEALTH

Chapter 61. CHRONIC DISEASES

Subchapter C. BREAST AND CERVICAL CANCER CONTROL PROGRAM

25 TAC §§61.31 - 61.42

The Texas Department of Health (department) adopts amendments to §§61.31 - 61.42 concerning the operation of the Texas Breast and Cervical Cancer Control Program (program). Sections 61.32, 61.34 - 61.35, 61.37, and 61.41 are adopted with changes to the proposed text as published in the November 9, 2001 issue of the Texas Register (26 TexReg 9012). Sections 61.31, 61.33, 61.36, 61.38 - 61.40 and 61.42 are adopted without changes, and therefore the sections will not be republished.

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 sections have been reviewed and the department has determined that reasons exist for readopting the sections continue to exist.

Specifically, the sections concern purpose and scope; federal authorization and requirements; eligible applicants; target population; selection process; program requirements; financial eligibility and screening guidelines; quality assurance standards; follow-up; maintenance of current services; reimbursement of costs; and client charges.

Section 61.31 is adopted to update the purpose and scope of the program. An amendment to §61.32 is adopted to incorporate references to the re-authorization of the enabling federal legislation and to clarify the department's role in managing the program. Section 61.33 is adopted to clarify the program's income eligibility requirements and the types of organizations eligible to apply for program funds. Adoption of §61.34 clarifies eligibility for program services. Adoption of amendment to §61.35 clarifies the criteria for selection of program service providers. Section 61.36 is adopted to clarify the requirements that applicant organizations must meet to qualify for program funding, including the addition of requirements for matching contributions. Adoption of §61.37 clarifies program financial eligibility and updates requirements for screening and diagnostic services. Section 61.38 concerning Quality Assurance Standards is adopted to repeal reference to publications in §61.32. Adoption of §61.39 adds requirements for follow-up and case management. Adoption of §61.40 updates the intent of the program to provide diagnostic services, client education, professional education, and case management. Adoption of §61.41 revises the reimbursement method used by the program and updates the method for determining reimbursement rates. Additionally, the amendment describes the conditions under which administrative and other costs are reimbursed. Adoption of §61.42 clarifies the program policy prohibiting the charging of fees to program clients.

The department is making the following minor changes due to staff comments to clarify the intent and improve the accuracy of the sections.

Change: Concerning §61.32, the phrase "prevention and control of" was deleted and replaced with "early detection of and prevention of mortality from" to clarify the program's intent and the department's authorization from the federal government.

Change: Concerning §61.34 in general, the department has stated specific eligibility criteria for breast cancer and for cervical cancer services, and deleted the references to the program's "target population" and "priority populations" to clarify that any woman who meets the age and income eligibility criteria will be served. The duty to designate "priority populations" in their respective service areas and to affirm that they will make a priority outreach effort to contact and to serve those populations applies only to applicants for program funding and will be addressed through the application process.

Change: Concerning §61.34(a), the phrase "and who do not have access to third-party payment for breast and cervical cancer screening or diagnostic services" was deleted for clarity because the same language already exists in §61.37(1).

Change: Concerning §61.35, the phrase "using criteria in §61.34 of this title (relating to Target and Priority Populations)" has been deleted for clarity because §61.34 has been amended to delete references to target and priority populations.

Change: Concerning §61.41(c), the phrase "and support services" has been added and the phrase "administrative costs include costs" has been deleted to clarify the definition of "reimbursable services".

Change: Concerning §61.41(d), the phrase "and support services" has been added to clarify the definition of reimbursable services.

The following comments were received concerning the proposed sections. Following each comment is the department's response and any resulting changes.

Comment: Concerning §61.34(a), one commenter asked if women 65 and over who do not have Medicare, even if eligible to apply but do not due to lack of funding, would be eligible for the BCCCP.

Response: Women eligible for Medicare but who do not have Part B coverage would not be eligible for Medicare reimbursement for outpatient physician services. Therefore, women age 65 who have access to no other third-party payment for breast and cervical cancer screening or diagnostic services would be eligible for BCCCP services. No changes were made as a result of this comment.

Comment: Concerning §61.37(5), one commenter stated that the section is unclear because it does not does not clearly state that women under age 18 are ineligible for cervical cancer services. The commenter compared §61.37(5) with §61.37(3), which states that women under age 40 are eligible for diagnostic services only.

Response: The department agrees that the section as proposed does not specifically deny eligibility for cervical cancer services to women under age 18, and has amended the section accordingly.

The commenter was the San Antonio Metropolitan Health District, expressing concerns and asking questions.

The amendments are adopted under the Health and Safety Code, §12.001, which provides the Texas Board of Health (board) with authority to adopt rules for the performance of every duty imposed by law on the board, the department, and the commissioner of health.

§61.32.Federal Authorization and Requirements.

The Breast and Cervical Cancer Mortality Prevention Act of 1990 (Act), Public Law 101-354, and its re-authorization, the Women's Health Research and Prevention Amendments of 1998, Public Law 105-340, establish a program of grants to states, territories, and tribal organizations for early detection of and prevention of mortality from breast and cervical cancer. The Texas Department of Health, through a cooperative agreement with the Centers for Disease Control and Prevention and in compliance with the Act and its reauthorization, manages the statewide Breast and Cervical Cancer Control Program (program).

§61.34.Eligibility For Program Services.

(a) Women eligible for Breast and Cervical Cancer Control Program (program) services must have incomes at or below 200% of the federal poverty level.

(b) Women age 40 or older with incomes at or below 200% of the federal poverty level are eligible for breast cancer screening services. Women under age 40 with incomes at or below 200% of the federal poverty level are eligible for diagnostic services only.

(c) Women age 18 or older with incomes at or below 200% of the federal poverty level are eligible for cervical cancer screening services.

§61.35.Selection Process.

Selection of applicants eligible to provide program services, as defined in §61.33 of this title (relating to Eligible Applicants), will be based on previous performance as service providers, and/or the merits of proposals submitted by eligible applicants.

§61.37.Program Eligibility Requirements.

Service providers shall demonstrate their ability to apply the following financial eligibility and screening services requirements:

(1) Only women with incomes at or below 200% of the federal poverty level and who have no access to third-party payment for screening and/or diagnostic services are eligible to receive Breast and Cervical Cancer Control Program (program) services. The program must be the payer of last resort.

(2) Breast cancer screening shall include a clinical breast examination and a mammogram.

(3) Only women age 40 or older are eligible for program-funded breast cancer screening services. Women under age 40 are eligible for diagnostic services only.

(4) Cervical cancer screening shall include a clinical breast examination, pelvic examination, and a Pap test.

(5) Only women age 18 or older are eligible for program-funded cervical cancer screening and diagnostic services.

(6) Participating providers may subcontract with other providers for clinical services.

§61.41.Reimbursement for Services.

(a) Reimbursement for clinical screening and diagnostic services shall be on a fee-for-service basis.

(b) Reimbursement will be subject to audit by the department. The Breast and Cervical Cancer Control Program (program) shall approve all covered procedures and reimbursement rates, which shall not exceed the maximum state Medicare rate for that procedure. A list of procedures approved for reimbursement shall be included in all program requests for proposals, contracts, and the program Manual of Operations.

(c) The program shall reimburse providers for administrative and support services costs associated with the following activities:

(1) eligibility determination;

(2) outreach;

(3) client education;

(4) data collection and reporting; and

(5) other activities authorized in advance.

(d) In order to be reimbursed for administrative and support services costs, a provider must request such reimbursement in its annual proposed budget. Administrative and support services cost reimbursement shall not exceed 10% of a service provider's budget for clinical services.

This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority.

Filed with the Office of the Secretary of State on May 3, 2002.

TRD-200202775

Susan K. Steeg

General Counsel

Texas Department of Health

Effective date: May 23, 2002

Proposal publication date: November 9, 2001

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


Chapter 99. OCCUPATIONAL DISEASES

25 TAC §99.1

The Texas Department of Health (department) adopts an amendment to §99.1 concerning Occupational Conditions with a change to the proposed text as published in the February 1, 2002, issue of the Texas Register (27 TexReg 676).

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 section has been reviewed and the department has determined that reasons for adopting the section continue to exist; however changes were necessary as described in this preamble.

The department published a Notice of Intention to Review the section as required by Government Code §2001.039 in the Texas Register on April 13, 2001 (26 TexReg 2855). No comments were received due to the publication of this notice.

The amendment changes the current name of the division responsible to receive reports of reportable occupational conditions. The division name has changed from Noncommunicable Disease Epidemiology and Toxicology Division to Environmental Epidemiology and Toxicology Division. Minor editorial changes were made to improve the accuracy of the section.

No comments were received during the comment period; however, a change was made due to a staff comment to correct punctuation in §99.1(c).

The amendment is adopted under Health and Safety Code, §84.003, which authorizes the board of health (board) to adopt rules relating to the reporting of occupational diseases and Health and Safety Code, §12.001, which provides the board with the authority to adopt rules for its procedure and for the performance of each duty imposed by law on the board, the department, or the commissioner of health.

§99.1.General Provisions.

(a) Purpose. This section implements the Texas Occupational Conditions Reporting Act, Health and Safety Code, Chapter 84, House Bill 2091, 69th Legislature, 1985, which authorizes the Texas Board of Health to adopt rules concerning the reporting and control of occupational conditions.

(b) Definitions. The following words and terms, when used in these sections, shall have the following meanings unless the context clearly indicates otherwise.

(1) Case--A person in whom an occupational condition is diagnosed by a physician based upon clinical evaluation, interpretation of laboratory and/or roentgenographic findings, and an appropriate occupational history.

(2) Commissioner--The commissioner of health.

(3) Department--The Texas Department of Health, 1100 West 49th Street, Austin, Texas 78756.

(4) Local health authority--The chief administrative officer of a public health district or a local health department, or the physician who is to administer state and local laws relating to public health.

(5) Occupational conditions--Those diseases, abnormal health conditions or laboratory findings that are caused by or are related to exposures in the workplace.

(6) Reportable occupational condition--Any occupational disease, condition or laboratory finding for which an official report is required. See subsection (d) of this section.

(7) Report of occupational condition--The notification to the appropriate authority of the occurrence of a specific occupational disease in a human, including all information required by the procedures established by the Board of Health.

(8) Suspected case--A case in which an occupational condition is suspected, but the final diagnosis is not yet made.

(c) Reporting requirements.

(1) It is the duty of every physician holding a license to practice in the State of Texas to report promptly to the local health authority each patient she or he shall examine and who has or is suspected of having any reportable occupational condition. The local health authority may authorize a staff member to transmit reports.

(2) It is the duty of every person who is in charge of a clinical or hospital laboratory, blood bank, mobile unit, or other facility in which a laboratory examination of any specimen derived from a human body yields microscopical, cultural, serological, chemical, or other evidence suggestive of a reportable condition to report promptly that information to the local health authority.

(3) The reporting physician or laboratory director shall make the report in writing. A local health authority may authorize one or more employees under his or her supervision to receive the report from the physician or laboratory director by telephone; use of this alternative, if authorized, is at the option of the reporter. The local health authority shall implement a method for verifying the identity of the telephone caller when that person is unfamiliar to the employee.

(4) The local health authority shall collect the reports and transmit the information at weekly intervals to the Environmental Epidemiology and Toxicology Division, Bureau of Epidemiology, Texas Department of Health, 1100 West 49th Street, Austin, Texas 78756. Transmission may be made by mail, courier, or electronic transfer.

(A) If by mail or courier, the reports shall be placed in a sealed envelope addressed to the attention of the Environmental Epidemiology and Toxicology Division, Bureau of Epidemiology, Texas Department of Health, 1100 West 49th Street, Austin, Texas, 78756, and marked "Confidential Medical Records."

(B) If by electronic transmission, including facsimile transmission by telephone, it shall be in a manner and form authorized by the commissioner or his or her designee in each instance. Any electronic transmission of the reports must provide at least the same degree of protection against unauthorized disclosure as those of mail or courier transmission. The commissioner or his or her designee shall, before authorizing such transmission, establish guidelines for establishing and conducting such transmission.

(5) When an occupational condition is reported to a local health authority, and the person diagnosed as having the condition resides outside his or her area of local health jurisdiction, the local health authority receiving the report shall notify the appropriate local health authority where the person or persons reside. The department shall assist the local health authority in providing such notifications if requested.

(d) List of reportable occupational conditions. Occupational conditions reportable by name, address, age, sex, race/ethnicity, method of diagnosis, and relevant occupation(s) and employer(s) of the case, and identity of the reporter, are: asbestosis, silicosis, blood lead levels at or above 25 micrograms lead/100 milliliters of blood in persons 15 years of age or older, and acute occupational pesticide poisoning.

(e) General control measures for reportable occupational conditions. The commissioner or his or her duly authorized representative shall, as circumstances may require, proceed as follows:

(1) investigation shall be made for the purpose of verifying the diagnosis, ascertaining the source of the causative agent, obtaining an occupational and employment history and discovering unreported cases;

(2) collection of specimens of the body tissues, fluids, or discharges and of materials directly or indirectly associated with the case, as may be necessary in confirmation of the diagnosis, and their submission to a laboratory for examination;

(3) obtaining samples of air or materials from the current or former business or place of employment of a case, as may be necessary to ascertain if a public health hazard exists. If a hazard is found the commissioner or his/her designee shall make appropriate recommendations concerning the hazard.

(f) Confidential nature of case reporting.

(1) All case reports received by the local health authority or the Texas Department of Health are confidential records and not public records. These records will be held in a secure location and accessed only by authorized personnel.

(2) The department may use information obtained from reports or health records for statistical and epidemiological studies which may be public information as long as an individual is not identifiable.

This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority.

Filed with the Office of the Secretary of State on May 3, 2002.

TRD-200202773

Susan K. Steeg

General Counsel

Texas Department of Health

Effective date: May 23, 2002

Proposal publication date: February 1, 2002

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


Chapter 229. FOOD AND DRUG

Subchapter T. LICENSURE OF TANNING FACILITIES

25 TAC §§229.343, 229.346, 229.350, 229.354

The Texas Department of Health (department) adopts amendments to §§229.343, 229.346, 229.350, and 229.354, concerning the licensure of tanning facilities. Section 229.346 is adopted with changes to the proposed text as published in the December 14, 2001 issue of the Texas Register (26 TexReg 10215). Sections 229.343, 229.350, and 229.354 are adopted without changes, and therefore will not be republished.

The amendments clarify and update the minimum standards for tanning facilities in order to conform with changes to the statutory provisions of House Bill 663, passed during the 77th Texas Legislature, and to allow the department to recover the costs of administering a regulatory program to inspect tanning facilities. Specifically, the amendments contain a new definition for "Fitzpatrick scale" that clarifies requirements for determining the skin type of consumers. In addition, the rules establish new licensure fees for tanning facilities to allow the department to recover the costs associated with inspecting tanning facilities and administering the program. The amended sections update warning signs required to be displayed at tanning facilities in order to reflect a toll-free telephone number for reporting to the department alleged injuries to consumers. The rules include new warnings that are added to the notice required to be furnished to consumers and contain new language to further define under what conditions minors are allowed access to tanning devices. Finally, the amendments clarify and add to the information required to be kept in individual consumer records, provide for restrictions to the public disclosure of these records, and establish a requirement for a log to be maintained by tanning facilities in order to track incidents of alleged injuries, failure to use protective eyewear, mechanical problems with a tanning device, and consumer complaints.

No comments were received during the comment period on the proposed amendments; however, the department is making the following change resulting from review of fiscal year 2001 cost data affecting the tanning facility inspection program:

Change: Concerning §229.346(a) and (b), the proposed annual licensure fees were adjusted downward from $245 to $220 so that the fees offset actual program costs incurred during the fiscal reporting period.

The amendments are adopted under Health and Safety Code, §145.011, which provides the department with the authority to adopt necessary regulations pursuant to the enforcement of Chapter 145; and §12.001, which provides the Texas Board of Health (board) 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.

§229.346.Licensing Fees.

(a) All tanning facilities in Texas shall pay a nonrefundable initial license fee of $220.

(b) All tanning facilities shall pay a nonrefundable annual renewal fee of $220 each year following issuance of the initial license.

(c) A tanning facility shall pay a $100 delinquency fee if:

(1) the license renewal fee is paid after the expiration date of the current license; or

(2) the initial license fee is paid more than 30 days following the effective date of a change in location, name, or ownership of an existing tanning facility as described in §229.345(h) of this title (relating to Licensing of Tanning Facilities).

(d) The department may, upon receipt of a written request from a license holder, prorate an annual license fee for the purpose of consolidating the anniversary dates of multiple licenses issued in the name of the license holder.

This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority.

Filed with the Office of the Secretary of State on May 6, 2002.

TRD-200202778

Susan K. Steeg

General Counsel

Texas Department of Health

Effective date: May 26, 2002

Proposal publication date: December 14, 2001

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