42 U.S.C. § 263b — Certification of mammography facilities

(a) Definitions. This part explains several words used later in the section. An "accreditation body" is a group the Secretary has approved to accredit mammography facilities. A "certificate" is the certificate described in part (b). A "facility" is a hospital, outpatient department, clinic, radiology practice, mobile unit, a doctor's office, or another place the Secretary names, that screens or diagnoses breast cancer using mammography — but not a Department of Veterans Affairs facility. A facility's covered activities include running the equipment, processing the film, giving the first reading of the mammogram, and providing proper viewing conditions for that reading. If the film processing or the reading happens somewhere else, the facility that actually took the mammogram must still meet the quality standards in part (f). An "inspection" is an onsite check by the Secretary, or by a state or local agency acting for the Secretary. A "mammogram" is the x-ray image; "mammography" is the process of x-raying the breast. A "survey" is an onsite check by a medical physicist, as described in part (f)(1)(E). A "review physician" is a doctor who meets the Secretary's rules and any extra rules an accreditation body sets, to review clinical images for that accreditation body under part (e)(1)(B)(i). (b) Certificate requirement. Starting October 1, 1994, no facility may do a mammography exam or procedure unless it holds a certificate that has been issued (and renewed, if needed), that covers the exam being done, and that is displayed prominently in the facility. This can be a regular certificate or temporary renewal certificate issued under part (c)(1) or (2), or a provisional certificate or limited provisional certificate issued under part (c)(3) or (4). Wherever this section mentions a "certificate," that includes all four kinds. A facility needs a certificate to run mammography equipment that images the breast, to interpret the resulting mammogram (even if that reading happens elsewhere), and to process the film (even if that happens elsewhere too). (c) Issuing and renewing certificates. The Secretary may issue or renew a certificate, for up to 3 years at a time, if the facility's owner or agent meets the application requirements in part (d)(1). The Secretary may also give a facility a temporary renewal certificate, lasting no more than 45 days, while it works on reaccreditation — but only if the accreditation body has granted the facility a matching extension of up to 45 days, because either the facility filed its paperwork on time but the accreditation body couldn't finish the review before the old certificate expired, or the facility got new equipment, had major staff changes, or hit some other unexpected problem that delayed reaccreditation without (in the accreditation body's judgment) hurting mammography quality. An accreditation body can also ask the Secretary to give an entity a limited provisional certificate, letting it do exams for training purposes while the accreditation body's site-visit team is physically there; this certificate is only valid while the team is on site, and never for more than 72 hours. Getting one of these doesn't stop the entity from also qualifying for a full provisional certificate. A provisional certificate lets an entity start operating as a facility; the applicant must meet the normal application rules in part (d)(1), except it does not have to submit the physicist-survey proof or the accreditation proof. A provisional certificate lasts up to 6 months, and can be extended once, for up to 90 more days, if the facility's owner, lessor, or agent shows the Secretary that without the extension, mammography access in the area the facility serves would shrink a lot — and describes, in a report to the Secretary, the steps the facility will take to become fully certified. (d) Applying for a certificate. To apply, the person who owns or leases the facility, or their authorized agent, must give the Secretary, in the form the Secretary requires: a description of the manufacturer, model, and type of each x-ray machine, image receptor, and processor the facility uses for mammography; a description of its current mammography procedures, including the types and number of procedures done in the past 12 months, the methods used, and the names and qualifications — education, training, and experience — of the staff who perform mammography and the physicians who read the results; proof that a qualified medical physicist has surveyed the site as described in part (f)(1)(E); and proof of accreditation, in the form the Secretary requires. The applicant must also give the Secretary satisfactory assurance that the facility will follow the Secretary's safety and accuracy standards under part (f); will allow inspections under part (g); will make records and information available and submit reports the Secretary asks for; will keep the submitted information and assurances updated on a timely basis; and will provide anything else the Secretary requires. An applicant does not have to resubmit information it already gave to the accreditation body that accredited it, unless the Secretary specifically requires it. If the Secretary denies a facility's application, the owner, lessor, or agent who applied must be given a written statement of the reasons and a chance to appeal, under the procedures in the Secretary's regulations at 42 C.F.R. part 498. If the application is denied, the facility may not operate unless it wins that appeal. (e) Accreditation. The Secretary may approve a private nonprofit organization or a state agency as an accreditation body if it meets the Secretary's standards for accreditation bodies and gives the required assurances. The standards must include: requiring the body to review clinical images from each facility it accredits at least every 3 years, and to review a random sample of clinical images from those facilities every 3 years starting October 1, 1994, both done by qualified review physicians; barring anyone who does those reviews from having any relationship with the facility being reviewed that would be a conflict of interest; keeping accreditation fees reasonable; requiring, as a condition of accreditation, that each facility get an annual onsite survey from a medical physicist under part (f)(1)(E), to check it meets the standards in part (f)(1)(A) and (B); requiring monitoring and evaluation of those surveys, as the Secretary prescribes; requiring standards at least as strong as the Secretary's own relevant standards under part (f); and any other standards the Secretary adds. The accreditation body must also assure the Secretary that it will follow those standards; meet the ongoing compliance duties in paragraph (4); tell the Secretary the name of any facility whose accreditation it denies, suspends, or revokes; give the Secretary timely notice before changing its own standards; timely notify each facility it accredits if the Secretary withdraws the body's approval under paragraph (2); and give the Secretary any other information required. The Secretary had to issue regulations for approving accreditation bodies within 9 months of October 27, 1992. The Secretary can withdraw an accreditation body's approval, under regulations the Secretary must write, if it stops meeting the standards or assurance requirements described above; when that happens, any facility the body accredited keeps its certificate until a reasonable deadline the Secretary sets, so it has time to get accredited by someone else. To be accredited, a facility must meet the standards from paragraph (1)(B) that the Secretary says apply to it, plus any other standards the accreditation body requires. To keep making sure its accredited facilities still meet its standards, an accreditation body must make onsite visits, after giving notice the Secretary requires, to enough of its facilities each year to reasonably judge its own overall performance, plus take any other steps the Secretary decides are appropriate. If an accreditation body revokes a facility's accreditation, the facility's certificate stays in effect until the Secretary decides otherwise. The Secretary must evaluate every approved accreditation body's performance each year — partly by inspecting, under part (g)(2), enough of the body's accredited facilities to fairly judge it, and partly by any other means the Secretary finds appropriate — and must send Congress's Senate Labor and Human Resources Committee and House Energy and Commerce Committee an annual report describing the results. (f) Quality standards. The standards the Secretary sets under part (d)(1)(B)(i) must require: each facility to run a quality assurance and quality control program strong enough to keep mammogram readings reliable, clear, and accurate, and to keep radiation doses appropriate; use of x-ray equipment built specifically for mammography, meeting standards for that equipment and any related materials; that people performing mammography be either state-licensed for radiological procedures or certified by an approved organization, that during the two years starting October 1, 1994 they meet training standards or have at least 1 year of mammography experience, and that after those two years they meet the regular minimum training standards; that mammograms be read by a physician certified — by an approved board, or through a program meeting the Secretary's standards — as qualified to interpret mammography, and who also meets the Secretary's training and continuing-education requirements; that people who survey mammography facilities be medical physicists who are state-licensed or state-approved for such surveys, certified in diagnostic radiological physics or by an approved board, or — for the first 5 years after October 27, 1992 — meet other comparable criteria the Secretary sets; that a medical physicist qualified under the previous point survey each facility's equipment and oversee its quality-assurance work; that a facility keep each mammogram in the patient's permanent medical record for at least 5 years — or at least 10 years if the patient has no later mammogram there, or longer if state law requires — and send the mammogram to another medical provider or to the patient on request; that a facility prepare a written report of each mammogram's results, signed by the interpreting physician, send that report to the patient's doctor if there is one, send it directly to the patient if there isn't, and — either way — always send the patient a plain-language summary of the results; and standards for special mammography techniques for patients with breast implants. None of this limits a patient's own right to access their medical records. Separately, the Secretary must decide, by regulation, which organizations may certify people to perform mammography, which boards may certify physicians to interpret it, what a physician-certification program must require, and which boards may certify the medical physicists who survey equipment and oversee quality assurance. (g) Inspections. The Secretary may enter and inspect facilities to check they meet the certificate rules in part (b) and the standards in part (f), and should hand this job to a state or local agency whenever that's practical. Inspectors — from the Secretary or from a state or local agency working for the Secretary — must show identification before inspecting. During an inspection, they may access, and may copy or require the facility to submit, any equipment, materials, records, or information they consider necessary to check whether the facility is following this section. Only qualified inspectors may conduct inspections; the Secretary sets minimum qualifications, training, and certification criteria for them, and may ask a state or local agency, or designate a federal officer or employee, to do the inspecting. Each facility must be inspected at least once a year, unless it's part of the demonstration program described below. The Secretary or the inspecting agency must keep inspection records for a period the Secretary sets, and an inspecting state or local agency must send the Secretary an annual report describing which facilities it inspected and what it found. On top of the annual inspections, the Secretary must separately inspect enough accredited facilities each year to reasonably judge how well each accreditation body is performing, and must separately inspect enough facilities that state or local agencies inspected to reasonably judge how well those agencies are performing. Inspections normally happen during business hours or at an agreed time, after the Secretary's required notice — except the Secretary can skip those requirements if a facility's continued mammography work threatens public health. Nothing here limits the Secretary's power to do extra, limited reinspections of facilities already found out of compliance. The Secretary may also run a demonstration program that inspects certain low-risk facilities less often than once a year. This program could not start before April 1, 2001, though preparations could begin earlier. It may only include facilities that are substantially free of past violations of the part (f) standards, and the Secretary can remove a facility from the program at any time. Enough facilities must be included to form a statistically meaningful sample. Facilities in the program must still be inspected often enough that the Secretary can reasonably be sure they're staying in compliance. (h) Sanctions. To encourage facilities to comply voluntarily, the Secretary may use lighter penalties instead of suspending or revoking a certificate under part (i): ordering a facility to follow a plan that corrects violations on a set timetable, or making the facility pay for the cost of onsite monitoring. If the Secretary decides a facility's mammography quality fell so far below the part (f) standards that it created a real risk to individual or public health — whether or not the facility is certified — the Secretary can require it to notify the patients it examined, and their doctors, about the problems, the possible harm, the right fix, and anything else the Secretary requires. The Secretary can also fine a facility up to $10,000 for each of these: failing to get a required certificate; each failure, or each day of failure, to substantially meet the part (f) standards or the reporting and inspection assurances in part (d)(1)(B)(ii); each failure to give a patient the risk notice the Secretary required under the point above; and each violation — or each instance of helping someone else violate — this section or its regulations, committed by a facility's owner, operator, or employee. The Secretary must set up procedures spelling out when and how each sanction is used, including notice to the facility's owner or operator, a reasonable chance to respond before a sanction is imposed, and a way to appeal sanction decisions. (i) Suspension and revocation. The Secretary may suspend or revoke a facility's certificate — after giving the owner or operator reasonable notice and a chance for a hearing, except as described below — if the Secretary finds that the facility's owner, operator, or an employee: lied to get the certificate; failed to meet the reporting assurance in part (d)(1)(B)(ii)(III) or the part (f) standards; failed to give the Secretary, or an approved accreditation body, records, information, reports, or materials reasonably needed to check the facility's continued eligibility or compliance; refused a reasonable request by the Secretary or a designated federal, state, or local officer to inspect the facility under part (g); violated, or helped someone else violate, this section or its regulations; or failed to comply with a sanction imposed under part (h). The Secretary may suspend a certificate before that hearing if there's reason to believe one of those findings will hold up, and either the violation was intentional or it poses a serious risk to human health. In that case, the Secretary must still offer a hearing within 60 days of the suspension, and the suspension stays in effect until the Secretary decides the case after the hearing. If the Secretary revokes a certificate based on one of these findings, no one who owned or operated that facility when the violation happened may own or operate a facility that needs a certificate under this section for 2 years after the revocation. (j) Injunctions. If the Secretary decides that a facility's continued mammography activity would seriously risk human health, the Secretary may sue in the federal district court where the facility is located to stop that activity; if the Secretary decides a facility is operating without a required certificate under part (b), the Secretary may sue there to stop the facility from operating. On a proper showing, the district court must grant a temporary injunction or restraining order — without requiring the Secretary to post a bond — while the case is pending. (k) Judicial review. If the Secretary sanctions a facility under part (h), or suspends or revokes its certificate under part (i), the facility's owner or operator may, within 60 days after the Secretary's action becomes final, petition the federal court of appeals for that circuit to review it. The court clerk sends the petition to the Secretary, who must file the record the decision was based on. If the petitioner asks the court to allow new evidence, and shows it's material and that there was a reasonable excuse for not presenting it earlier, the court can send it back to the Secretary to take that evidence (and any rebuttal). Based on that new evidence, the Secretary may then revise or add findings and send them back to the court along with any recommendation to change the original decision. The court can affirm the Secretary's action, or set it aside in whole or in part, temporarily or permanently; the Secretary's factual findings are final if supported by substantial evidence. The court's final judgment can still be reviewed by the Supreme Court on certiorari or certification. (l) Public information. Starting October 1, 1996 and every year after, the Secretary must compile and make public information useful for judging how facilities perform, including lists of facilities that: were convicted under federal or state fraud, false-billing, or kickback laws; were sanctioned under part (h), with the reasons; had a certificate revoked or suspended under part (i), with the reasons; the Secretary took action against under part (j), with the reasons; had their accreditation revoked, with the reasons; had adverse action taken against them by a state; or meet any other performance measure the Secretary develops. Each year's information covers the calendar year before it is released, and must come with enough explanation to help readers interpret it. (m) State laws. Nothing here limits a state's power to pass and enforce its own laws on these same subjects, as long as those laws are at least as strict as this section or its regulations. (n) National Advisory Committee. The Secretary must set up the National Mammography Quality Assurance Advisory Committee, made up of 13 to 19 people who are not federal officers or employees, appointed from physicians, other practitioners, and health professionals whose work has a real focus on mammography — including at least 4 people from national breast cancer or consumer health groups with mammography expertise, at least 2 people from mammography-equipment companies, and at least 2 practicing physicians who provide mammography services. The Committee must advise the Secretary on quality standards and regulations for facilities and for accreditation bodies; advise on developing sanction regulations; help develop ways to monitor compliance with the part (f) standards; help set up a way to investigate consumer complaints; report on new breast-imaging developments relevant to overseeing facilities; determine whether rural and health-professional-shortage areas lack enough facilities, and how the part (f) requirements affect access there; determine whether there will be enough medical physicists after October 1, 1999 to meet the part (f)(1)(E) requirements; determine the costs and benefits of complying with this section and its regulations; and do any other work the Secretary assigns. The Committee had to report its findings on the rural-access and cost-benefit questions to the Secretary and Congress by October 1, 1993. It must meet at least quarterly for its first 3 years, then at least annually after that, and the Secretary appoints its chairperson. (o) Consultations. In carrying out this section, the Secretary must consult with the relevant agencies inside the Department of Health and Human Services when developing standards, regulations, evaluations, and compliance and oversight procedures. (p) Breast cancer screening surveillance research grants. The Secretary must award grants to appropriate entities to set up surveillance systems in selected areas that gather data to evaluate how well breast cancer screening programs work in the United States — including screening participation rates, diagnostic procedures, breast cancer rates, how cancers are found (screening or otherwise), outcomes, follow-up, and related research that could improve early detection and reduce breast cancer deaths. The Secretary may award more grants for further surveillance research after reviewing how the program is going. Grant money may be used to study ways to link mammography and clinical breast exam records with population-based cancer registry data, ways to give diagnostic outcome data back to radiology facilities (or help communicate it to them) so they can evaluate their own mammography interpretation patterns, and ways to limit access to and keep confidential all stored data — and to pilot-test those methods on a limited basis. To get a grant, an entity must apply as the Secretary requires. A grant recipient must report back to the Secretary on the results of its study and testing, along with recommendations for building a breast cancer screening surveillance system. Based on those recommendations, the Secretary must then build an actual breast cancer screening surveillance system, and must set standards and procedures for running it, including procedures to keep patient records confidential. The Secretary must also recruit facilities to send data to that system that could help research the causes, characteristics, prevalence, and possible treatments of breast cancer and benign breast conditions, as long as disclosing that information is allowed under section 552 of title 5. (q) State programs. The Secretary may, if a state applies, let that state take over — subject to paragraph (2) — the certification-program work under parts (b), (c), (d), (g)(1), (h), (i), and (j) (including their regulations), and apply the Secretary's part (f) standards, for mammography facilities operating in that state. The Secretary may approve such an application if the state has enacted laws and issued regulations matching this section's requirements, and gives satisfactory assurance that it has the legal authority and qualified staff to enforce them, will spend adequate funds enforcing them, and will give the Secretary the information and reports required. In an approved state, the Secretary still carries out the accreditation and standard-setting work under parts (e) and (f); may still take action under the sanctions, suspension/revocation, and injunction rules in parts (h), (i), and (j); and still handles the oversight inspections described in parts (g)(2) and (g)(3). The Secretary may, after giving notice and a chance to fix the problem, withdraw a state's approval — under regulations the Secretary must write — if the state stops meeting these requirements. If approval is withdrawn, a facility's state-issued certificate stays in effect for a reasonable period the Secretary sets, so the facility has time to get certified by the Secretary instead. (r) Funding. The Secretary must assess and collect fees from facility owners or agents described in part (d)(1)(A) — except government entities — to cover the cost of the annual inspections done under part (g)(1) by the Secretary or by a state acting under a delegation. Fees must be set so that the total collected in a fiscal year roughly equals that year's total inspection costs for those facilities, and each person's fee must reasonably reflect their share of those costs. These fees are deposited as an offsetting collection to the Department of Health and Human Services' appropriations and stay available without a year limit, but only to the extent Congress's appropriations acts allow them to be collected and spent. Congress is authorized to appropriate whatever sums are necessary to fund the research grants under part (p), and the Secretary's other work under this section not covered by fees, for each of fiscal years 1993 through 2007.