Part 1. DEPARTMENT OF STATE HEALTH SERVICES
Chapter 289. RADIATION CONTROL
Subchapter D. GENERAL
The Executive Commissioner of the Health and Human Services Commission (commission), on behalf of the Department of State Health Services (department), adopts an amendment to §289.204 concerning radiation control fees, specifically mammography certification and accreditation fees, without changes to the proposed text as published in the December 29, 2006, issue of the Texas Register (31 TexReg 10515) and, therefore, the section will not be republished.
BACKGROUND AND PURPOSE
The amendment is necessary because the department is applying to the United States Food and Drug Administration (FDA) to become a certifying body for mammography facilities. Currently, the department has a contract with the FDA to perform inspections and the FDA bills individual facilities for the cost of those inspections. When the department becomes a certifying body, the contract with the FDA will not be extended and fees for performing inspections as well as fees for the certification process will be incorporated into one certification fee paid to the agency by each facility. In addition, the department has fees for mammography accreditation. Increases to the mammography accreditation fees reflect increases to costs charged to the department for services provided by the American College of Radiology (ACR). The department contracts with the ACR to provide quality assurance reviews of mammography films for accreditation. Additional costs of administration and enforcement of the program, due to a recent legislative increase in pay, longevity pay, and travel reimbursement, were also included in the evaluation to determine the direct and indirect costs of each program.
SECTION-BY-SECTION SUMMARY
In §289.204(b)(1)(C), the amendment changes references to §289.230 (relating to Certification of Mammography Systems and Mammography Machines Used for Interventional Breast Radiography) to state the correct title of the rule being cited. Section §289.234 (relating to Mammography Accreditation) is added to reflect a new rule section. Amendments to §289.204(g) clarify the subsection title and add language stating that no application will be accepted for filing or processed prior to payment of the full amount specified. Section 289.204(g)(1) reflects changes in the fees charged to a facility for certification. Currently a facility pays a $422 certification fee to the department and a $1,749 inspection fee to the FDA for a total of $2,171. When the department becomes a certifying body, fees for performing inspections as well as fees for the certification process will be incorporated into one certification fee of $1,745 paid to the department by each facility. Certifications with more than one machine (system) on the same certification will be charged an additional $204 for each additional machine. Section 289.204(g)(2) changes the annual fee to $1,745 with an additional charge of $204 for each additional machine on the certification.
Language is added to §289.204(g)(3)(A) to clarify that the fee for mammography machines used for interventional breast radiography is $422. Certifications with more than one interventional breast radiography machine on the same certification will be charged an additional $204 for each additional machine. In §289.204(g)(3)(B), the annual fee for mammography machines used for interventional breast radiography is $422 with an additional $204 charged for each additional machine on the certification.
In §289.204(h)(2)(A)-(B), the cost of quality assurance reviews of mammography films by the ACR is increasing. The accreditation fee will increase from $880 to $980 for the first machine. The fee for each additional machine will increase from $490 to $585. Other fees charged by the ACR are also increasing. In §289.204(h)(2)(C), the fee for re-evaluation of clinical images is changing from $270 to $305. In §289.204(h)(2)(D), the fee for phantom image review is increasing from $210 to $340. The fee for reinstatement of mammography machines in §289.204(h)(2)(F) is changing from $610 to $585. Section 289.204(h)(2)(G) reflects a $5 increase in the amount for processing thermolumenescent dosimeters.
COMMENTS
The department, on behalf of the commission, has reviewed and prepared a response to a comment received regarding the proposed rule during the comment period, which the commission has reviewed and accepts. The commenter was a representative from the FDA. The commenter was in favor of the rule; however, the commenter suggested recommendations for change as discussed in the summary of comments.
Comment: Concerning the lack of a fee for follow-up inspections in §289.204(g), the commenter asked if the State of Texas was planning to absorb the cost of conducting follow-up inspections from the other certification fees collected or should a fee for this activity be included.
Response: The commission disagrees with the comment because the program has not been requested by the FDA to conduct follow-up inspections; however, should this become an issue in the future, it will be reviewed. No change was made to the rule as a result of this comment.
LEGAL CERTIFICATION
The Department of State Health Services, General Counsel, Cathy Campbell, certifies that the rule, as adopted, has been reviewed by legal counsel and found to be a valid exercise of the agencies' legal authority.
STATUTORY AUTHORITY
The amendment is adopted under the Health and Safety Code, §12.0111, which requires the department to charge fees for issuing or renewing a license; Health and Safety Code, §401.301, which allows the department to collect fees for radiation control registrations that it issues; §401.051, which provides the Executive Commissioner of the Health and Human Services Commission with authority to adopt rules and guidelines relating to the control of radiation; 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.
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 April 10, 2007.
TRD-200701339
Cathy Campbell
General Counsel
Department of State Health Services
Effective date: April 30, 2007
Proposal publication date: December 29, 2006
For further information, please call: (512) 458-7111 x6972
Subchapter A. VETERANS AGENT ORANGE ASSISTANCE PROGRAM
The Executive Commissioner of the Health and Human Services Commission (commission), on behalf of the Department of State Health Services (department), adopts the repeal of §§339.1 - 339.6, concerning the Veterans Agent Orange Assistance Program without changes to the proposed text as published in the November 10, 2006, issue of the Texas Register (31 TexReg 9205) and, therefore, the sections will not be republished.
BACKGROUND AND PURPOSE
House Bill 2129, 67th Legislature, Regular Session, 1981, created the Texas Veterans Agent Orange Assistance Program. It was amended by Senate Bill 370, 68th Legislature, Regular Session, 1983. This legislation is codified as Health and Safety Code, Chapter 83. The purpose of the program was to assist Texas veterans of the Vietnam conflict who may have been exposed to Agent Orange, an herbicide used as a defoliant in Vietnam from 1965-1971 by U.S. military forces, and suspected of creating long-term health problems to those exposed. Legacy agency, Texas Department of Health, Bureau of Epidemiology, administered the Agent Orange program and investigated the cause and effect relationships between the exposure of Vietnam veterans to herbicides, chemical defoliants, or other causative agents and the emergence of health problems.
The repeal of the rules is based on Health and Safety Code, §83.010, Termination of Program and Duties. The Texas Legislature did not continue funding for the Agent Orange program; therefore, the program was phased out as of August 31, 1985. The original legislation provided that programs required by Health and Safety Code, Chapter 83, could be discontinued if "an agency of the federal government is performing the referral and screening functions required" under this law. The Veteran's Administration has long provided these services, so this program is no longer required by law.
Government Code, §2001.039, requires that each state agency review and consider for readoption each rule adopted by that agency pursuant to Government Code, Chapter 2001 (Administrative Procedure Act). Sections 339.1 - 339.6 have been reviewed and the department has determined that reasons for adopting the sections no longer exist.
SECTION-BY-SECTION SUMMARY
The repeal of §§339.1 - 339.6 is allowed because the Veteran's Administration now offers Agent Orange services.
COMMENTS
The department, on behalf of the commission, did not receive any comments regarding the proposed rules during the comment period, and no changes were made to the proposal.
LEGAL CERTIFICATION
The Department of State Health Services, General Counsel, Cathy Campbell, certifies that the rules, as adopted, have been reviewed by legal counsel and found to be a valid exercise of the agencies' legal authority.
STATUTORY AUTHORITY
The repeals are authorized under Health and Safety Code, §83.010, Termination of Program and Duties; 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 review of the sections implements Government Code, §2001.039.
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 April 10, 2007.
TRD-200701340
Cathy Campbell
General Counsel
Department of State Health Services
Effective date: April 30, 2007
Proposal publication date: November 10, 2006
For further information, please call: (512) 458-7111 x6972