Mammography Authorization

PURPOSE: This rule establishes requirements for mammography authorization and payment of fees by mammography suppliers. (1) All mammography suppliers shall meet the requirements of applicable rules of Chapter 10 of 19 CSR 20. (2) Each applicant for mammography authorization shall submit a registration fee to the Department of Health prior to issuance of the mammography authorization. Fees are as follows: three (3)-year authorization, six hundred dollars ($600); temporary authorization for twelve (12) months, two hundred dollars ($200); and temporary authorization for six (6) months, one hundred dollars ($100). (A) Each radiation machine shall be individually registered for mammography authorization. (B) Application for authorization renewal shall be submitted not more than ninety (90) days and not less than thirty (30) days prior to the expiration date of the current authorization. (C) Registration fees shall not be required for reinstatement of a mammography authorization which has been withdrawn by the Department of Health; reinstatement shall be effective only for the remainder of the original period of authorization. (3) The Department of Health shall perform an initial inspection of each machine during the first year of authorization and annual inspections after that. A reinspection shall be performed after a mammography authorization has been withdrawn by the Department of Health. Fees for initial inspection, annual inspection and reinspection shall be one hundred dollars ($100) respectively, per radiation machine. (A) Fees for initial inspection shall be submitted with the application for mammography authorization. (B) Fees for annual inspection shall be submitted ten (10) working days prior to the anniversary date of the mammography authorization. (C) Fees for reinspection shall be submitted upon application for reinstatement of mammography authorization. (4) The Department of Health may accept mammography accreditation certificates issued by the American College of Radiology (ACR) as evidence of compliance with criteria for authorization. Suppliers who submit ACR accreditation certificates as evidence of compliance shall inform the Department of Health, in writing, of any change in their ACR accreditation status within thirty (30) days of that change. If the Department of Health evaluates mammography systems to determine compliance with criteria for authorization, evaluation shall be performed every three (3) years and shall include review and on-site evaluation of staff qualifications, equipment, quality control and quality assurance programs, phantom image quality, breast dose and processor quality control. In addition, the supplier shall submit two (2) sets of clinical films, one (1) of a fatty and one (1) of a dense breast, for image quality evaluation to the Department of Health or its designee. Each set shall consist of two (2) views of each breast totaling four (4) films for each type of breast. Failure to meet clinical image quality evaluation criteria shall result in the withholding or withdrawal of mammography authorization. The supplier may submit additional clinical films for reevaluation; however, all costs incurred for additional clinical image quality evaluation shall be the responsibility of the supplier. Fees for evaluation shall be five hundred dollars ($500) for the first radiation machine and four hundred dollars ($400) for each additional radiation machine. Fees for the Department of Health evaluation shall be submitted prior to the evaluation. The supplier shall provide to the Department of Health all evidence required to determine compliance with criteria for authorization. (5) Failure of the supplier, upon inspection or evaluation, to meet the requirements of this chapter that significantly affect clinical image quality or interpretation shall result in immediate withdrawal of authorization. The Department of Health shall provide an opportunity for a hearing within five (5) working days after withdrawal of authorization. Whenever the Department of Health finds upon inspection or evaluation that there is a violation of other provisions of this chapter, the Department of Health shall notify the supplier of the nature of the violation and order that prior to a time fixed by the Department of Health, which shall not be later than thirty (30) days from the date of service of the notice, the supplier shall cease and abate causing, allowing or permitting the violation. Failure to meet this requirement shall result in withdrawal of authorization. (6) Fees submitted to the Department of Health under this rule are nonrefundable. Failure to submit fees as required shall result in withdrawal of the mammography authorization. AUTHORITY: sections 192.760, 192.762, 192.764 and 192.766, RSMo Supp. 1992.* This rule was previously filed as 19 CSR 2011.010. Emergency rule filed Oct. 5, 1992, effective Oct. 15, 1992, expired Feb. 12, 1993. Emergency rule filed Feb. 3, 1993, effective Feb. 13, 1993, expired June 12, 1993. Original rule filed Nov. 4, 1992, effective June 7, 1993. Changed to 19 CSR 3011.010 July 30, 1998. *Original authority 1992.