S 2006 — Breast Density and Mammography Reporting Act of 2017

(a) Definitions As used in this section: (1) Accreditation body The term “accreditation body” means a body that has been approved by the Secretary under subsection (e)(1)(A) to accredit mammography facilities. (2) Certificate The term “certificate” means the certificate described in subsection (b)(1). (3) Facility (A) In general The term “facility” means a hospital, outpatient department, clinic, radiology practice, or mobile unit, an office of a physician, or other facility as determined by the Secretary, that conducts breast cancer screening or diagnosis through mammography activities. Such term does not include a facility of the Department of Veterans Affairs. (B) Activities For the purposes of this section, the activities of a facility include the operation of equipment to produce the mammogram, the processing of the film, the initial interpretation of the mammogram and the viewing conditions for that interpretation. Where procedures such as the film processing, or the interpretation of the mammogram are performed in a location different from where the mammogram is performed, the facility performing the mammogram shall be responsible for meeting the quality standards described in subsection (f). (4) Inspection The term “inspection” means an onsite evaluation of the facility by the Secretary, or State or local agency on behalf of the Secretary. (5) Mammogram The term “mammogram” means a radiographic image produced through mammography. (6) Mammography The term “mammography” means radiography of the breast. (7) Survey The term “survey” means an onsite physics consultation and evaluation performed by a medical physicist as described in subsection (f)(1)(E). (8) Review physician The term “review physician” means a physician as prescribed by the Secretary under subsection (f)(1)(D) who meets such additional requirements as may be established by an accreditation body under subsection (e) and approved by the Secretary to review clinical images under subsection (e)(1)(B)(i) on behalf of the accreditation body. (b) Certificate requirement (1) Certificate No facility may conduct an examination or procedure described in paragraph (2) involving mammography after October 1, 1994, unless the facility obtains— (A) a certificate or a temporary renewal certificate— (i) that is issued, and, if applicable, renewed, by the Secretary in accordance with paragraphs 1 (1) or (2) of subsection (c); (ii) that is applicable to the examination or procedure to be conducted; and (iii) that is displayed prominently in such facility; or (B) a provisional certificate or a limited provisional certificate— (i) that is issued by the Secretary in accordance with paragraphs (3) and (4) of subsection (c); (ii) that is applicable to the examination or procedure to be conducted; and (iii) that is displayed prominently in such facility. The reference to a certificate in this section includes a temporary renewal certificate, provisional certificate, or a limited provisional certificate. (2) Examination or procedure A facility shall obtain a certificate in order to— (A) operate radiological equipment that is used to image the breast; (B) provide for the interpretation of a mammogram produced by such equipment at the facility or under arrangements with a qualified individual at a facility different from where the mammography examination is performed; and (C) provide for the processing of film produced by such equipment at the facility or under arrangements with a qualified individual at a facility different from where the mammography examination is performed. (c) Issuance and renewal of certificates (1) In general The Secretary may issue or renew a certificate for a facility if the person or agent described in subsection (d)(1)(A) meets the applicable requirements of subsection (d)(1) with respect to the facility. The Secretary may issue or renew a certificate under this paragraph for not more than 3 years. (2) Temporary renewal certificate The Secretary may issue ...