Text: H.R.5938 — 102nd Congress (1991-1992)All Information (Except Text)

Text available as:

Shown Here:
Reported in House

 
 
Union Calendar No. 505
102d CONGRESS
2d Session
H. R. 5938
[Report No. 102-889]
A BILL
To amend the Public Health Service Act to establish the authority for the
regulation of mammography services and radiological equipment, and for
other purposes.
September 22, 1992
Reported with an amendment, committed to the Committee of the Whole House
on the State of the Union, and ordered to be printed
HR 5938 RH
Union Calendar No. 505
102d CONGRESS
2d Session
 H. R. 5938
[Report No. 102-889]
To amend the Public Health Service Act to establish the authority for the
regulation of mammography services and radiological equipment, and for
other purposes.
IN THE HOUSE OF REPRESENTATIVES
September 15, 1992
Mr. DINGELL (for himself, Mr. WAXMAN, Mrs. SCHROEDER, Mrs. LLOYD, Mr. FORD
of Michigan, Mr. SIKORSKI, Mr. BRUCE, Mr. ROWLAND, Mr. TOWNS, Mr. STUDDS,
Mr. SCHEUER, Mr. WYDEN, Mr. RICHARDSON, Mr. SYNAR, and Mr. BILIRAKIS)
introduced the following bill; which was referred to the Committee on Energy
and Commerce
September 22, 1992
Additional sponsors: Mr. MANTON, Mr. ROSE, Mr. STOKES, Mr. HOCHBRUECKNER,
Mr. HARRIS, Mr. EVANS, Mr. MAZZOLI, Mr. BLACKWELL, and Ms. Horn
September 22, 1992
Reported with an amendment, committed to the Committee of the Whole House
on the State of the Union, and ordered to be printed
[Strike out all after the enacting clause and insert the part printed
in italic]
[For text of introduced bill, see copy of bill as introduced on September
15, 1992]
A BILL
To amend the Public Health Service Act to establish the authority for the
regulation of mammography services and radiological equipment, and for
other purposes.
  Be it enacted by the Senate and House of Representatives of the United
  States of America in Congress assembled,
SECTION 1. SHORT TITLE.
  This Act may be cited as the `Mammography Quality Standards Act of 1992'.
SEC. 2. CERTIFICATION OF MAMMOGRAPHY FACILITIES.
  Part F of title III of the Public Health Service Act (42 U.S.C. 262 et
  seq.) is amended by adding at the end the following new subpart:
`Subpart 3--Mammography Facilities
`SEC. 354. CERTIFICATION OF MAMMOGRAPHY FACILITIES.
  `(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)(2)(A) to accredit
  mammography facilities.
  `(2) CERTIFICATE- The term `certificate' means the certificate described
  in subsection (b)(1).
  `(3) CERTIFIED FACILITY- The term `certified facility' means a facility to
  which the Secretary has issued and, if appropriate, renewed a certificate
  in accordance with subsection (c).
  `(4) 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 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 taken, the facility
  taking the mammogram shall be responsible for meeting the quality standards
  described in subsection (f).
  `(5) INSPECTION- The term `inspection' means an onsite evaluation of the
  facility by the Secretary, or State agency on behalf of the Secretary.
  `(6) MAMMOGRAM- The term `mammogram' means a radiographic image produced
  through mammography.
  `(7) MAMMOGRAPHY- The term `mammography' means radiography of the breast.
  `(8) SURVEY- The term `survey' means an onsite physics consultation and
  evaluation performed by a medical physicist as described in subsection
  (f)(1)(E).
  `(b) CERTIFICATE REQUIREMENT-
  `(1) CERTIFICATE- No facility may conduct an examination or procedure
  described in paragraph (2) involving mammography after July 1, 1994,
  unless the facility obtains--
  `(A) a certificate--
  `(i) that is issued, and, if applicable, renewed, by the Secretary in
  accordance with subsection (c)(1);
  `(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--
  `(i) that is issued by the Secretary in accordance with subsection (c)(2);
  `(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 subsection and subsections (c) and
(d) includes a provisional certificate.
  `(2) EXAMINATION OR PROCEDURE- A facility shall obtain a certificate in
  order to--
  `(A) operate equipment that is used to image the breast in performing
  mammography;
  `(B) provide the interpretation of a mammogram produced by such equipment
  regardless of whether the interpretation is performed at a site different
  from where the mammography examination is performed; and
  `(C) provide for the processing of film produced by such equipment,
  regardless of whether the processing is performed at a site 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, entity, or agent described in subsection (d)(1)
  meets the applicable requirements of subsection (d) with respect to
  the facility. The Secretary may issue or renew a certificate under this
  paragraph for not more than 3 years.
  `(2) PROVISIONAL CERTIFICATE- The Secretary may issue a provisional
  certificate for an entity to enable the entity to qualify as a facility. A
  provisional certificate--
  `(A) may not be renewed and the applicant for a provisional certificate
  shall meet the requirements of subsection (d), except providing information
  required by subparagraphs (C) and (D) of subsection (d)(1), and
  `(B) may be in effect no longer than 6 months from the date it is issued.
  `(d) APPLICATION FOR CERTIFICATE- The Secretary may issue or renew a
  certificate for a facility if--
  `(1) the person or entity who owns or leases the facility or an authorized
  agent of the person, submits to the Secretary, in such form and manner as
  the Secretary shall prescribe, an application that contains at a minimum--
  `(A) a description of the manufacturer, model, and type of each x-ray
  machine, image receptor, and processor operated in the performance of
  mammography by the facility;
  `(B) a description of the procedures currently used to provide mammography,
  or other procedures related to the detection of cancerous or potentially
  cancerous breast tissue, at the facility, including--
  `(i) the types of procedures performed and the number of such procedures
  performed in the prior 12 months;
  `(ii) the methodologies for mammography; and
  `(iii) the names and qualifications (educational background, training,
  and experience) of the personnel performing mammographies, the medical
  physicist surveying mammography equipment and providing oversight for the
  quality assurance program at the facility, and the physicians reading and
  interpreting the results from the procedures;
  `(C) proof of on-site survey by a qualified medical physicist as described
  in subsection (f)(1)(E);
  `(D) proof of accreditation in such manner as the Secretary shall prescribe;
  and
  `(2) the person, entity, or agent submits to the Secretary--
  `(A) a satisfactory assurance that the facility will be operated in
  accordance with standards established by the Secretary under subsection
  (f) to assure the safety and accuracy of mammography;
  `(B) a satisfactory assurance that the facility will--
  `(i) permit inspections under subsection (g);
  `(ii) make such records and information available, and submit such reports,
  to the Secretary as the Secretary may require; and
  `(iii) update the information submitted under paragraph (1) or this
  paragraph not later than 30 days after the date the information becomes
  incomplete or inaccurate; and
  `(C) such other information as the Secretary may require.
The Secretary shall attempt to limit the information supplied by an applicant
under paragraph (1) with respect to any information which the applicant has
supplied to the accreditation body which accredited the applicant.
  `(e) ACCREDITATION-
  `(1) IN GENERAL- The Secretary may consider a facility to be accredited
  for purposes of subsection (d)(1)(D) if the facility--
  `(A) meets the standards of an approved accreditation body as described
  in paragraph (2)(A); and
  `(B) authorizes the accreditation body to submit to the Secretary (and
  such State agency as the Secretary may designate) such information as the
  Secretary may require.
  `(2) APPROVAL OF ACCREDITATION BODIES-
  `(A) IN GENERAL- The Secretary may approve a private nonprofit organization
  or State agency to accredit facilities for purposes of subsection (d)(1)(D)
  if the accreditation body meets the standards for accreditation established
  by the Secretary as described in subparagraph (B).
  `(B) STANDARDS- The Secretary shall establish standards for accreditation
  bodies, including--
  `(i) standards that require accreditation bodies to perform--
  `(I) a review of clinical images from each facility required to have a
  certificate under subsection (b) not less often than every 3 years which
  review will be made by qualified practicing physicians; and
  `(II) a review by qualified practicing physicians of a random sample of
  clinical images from such facilities in each 3-year period beginning July
  1, 1994;
  `(ii) standards that prohibit individuals conducting the review described
  in clause (i) from maintaining any contractual or financial relationship
  to the facility undergoing review;
  `(iii) standards that limit the imposition of fees for accreditation to
  reasonable amounts.
  `(C) ASSURANCES- The accrediting body shall provide the Secretary
  satisfactory assurances that the body will--
  `(i) comply with the standards as described in subparagraph (B);
  `(ii) comply with the requirements described in paragraphs (4) and (5);
  `(iii) submit to the Secretary the name of any facility for which the
  accreditation body denies, suspends, withdraws, or revokes accreditation,
  or against which the body takes any other adverse action, within 48 hours
  of the action;
  `(iv) notify the Secretary at least 60 days before the accreditation body
  changes the standards of the body; and
  `(v) notify each facility accredited by the accreditation body if the
  Secretary withdraws approval of the accreditation body under paragraph
  (3), within 21 days of the withdrawal.
  `(D) REGULATIONS- The Secretary shall promulgate regulations under which
  the Secretary may approve an accreditation body.
  `(3) WITHDRAWAL OF APPROVAL-
  `(A) IN GENERAL- The Secretary shall promulgate regulations under which
  the Secretary may withdraw the approval of an accreditation body if the
  Secretary determines that the accreditation body does not meet the standards
  under subparagraph (B) of paragraph (2) and the requirements of clauses
  (i) through (iv) of subparagraph (C) of paragraph (2).
  `(B) EFFECT OF WITHDRAWAL- If the Secretary withdraws the approval of an
  accreditation body under subparagraph (A), the certificate of any facility
  accredited by the body shall continue in effect until the expiration of
  a reasonable period, as determined by the Secretary, for such facility to
  obtain another accreditation.
  `(4) ACCREDITATION- In determining whether or not to accredit a facility,
  an approved accreditation body shall--
  `(A) require as a condition of accreditation that each facility undergo a
  survey at least annually by a medical physicist as described in subsection
  (f)(1)(E) to ensure that the facility meets the standard described in
  subsection (f)(1)(A); and
  `(B) monitor and evaluate such survey, as prescribed by the Secretary; and
  `(C) apply standards equal to or more stringent than the relevant standards
  established by the Secretary under subsection (f).
  `(5) COMPLIANCE- To ensure that facilities accredited by an accreditation
  body will continue to meet the standards of the accreditation body, the
  accreditation body shall--
  `(A) make onsite visits on an annual basis of a percentage of the facilities
  accredited by the accreditation body as determined by the Secretary;
  `(B) report the results of such onsite visits to the Secretary on an annual
  basis; and
  `(C) take such additional measures as the Secretary determines to be
  appropriate.
Visits made under subparagraph (A) shall be made after providing 48 hours
notice.
  `(6) REVOCATION OF ACCREDITATION- If an accreditation body withdraws or
  revokes the accreditation of a facility, the certificate of the facility
  shall continue in effect until the later of--
  `(A) 90 days after the facility receives notice of the withdrawal or
  revocation of the accreditation; or
  `(B) the effective date of any action taken by the Secretary under subsection
  (h) or (i).
  `(7) EVALUATION AND REPORT-
  `(A) EVALUATION- The Secretary shall evaluate annually the performance of
  each approved accreditation body by--
  `(i) inspecting under subsection (g)(2) a sufficient number of the facilities
  accredited by the body to allow a reasonable estimate of the performance
  of the body; and
  `(ii) such additional means as the Secretary determines to be appropriate.
  `(B) REPORT- The Secretary shall annually prepare and submit to the
  Committee on Labor and Human Resources of the Senate, the Committee on
  Energy and Commerce of the House of Representatives, and the National
  Mammography Quality Assurance Advisory Board established under subsection
  (o) a report that describes the results of the evaluation conducted in
  accordance with subparagraph (A).
  `(f) QUALITY STANDARDS-
  `(1) IN GENERAL- The standards referred to in subsection (d)(2)(A) are
  standards established by the Secretary which include--
  `(A) standards that require establishment and maintenance of a quality
  assurance and quality control program at the facility that is adequate and
  appropriate to ensure the reliability, clarity, and accurate interpretation
  of mammographies and standards for appropriate radiation doses;
  `(B) standards that require use of radiological equipment specifically
  designed for mammography, including radiologic standards and standards for
  other equipment and materials used in conjunction with the radiological
  equipment;
  `(C) a requirement that personnel who perform mammography--
  `(i)(I) be licensed by a State to perform mammographies; or
  `(II) be certified as qualified to perform mammographies by an organization
  described in paragraph (2)(A); and
  `(ii) meet minimum training standards for personnel who perform mammograms;
  `(D) a requirement that mammograms be interpreted by a physician who is
  certified as qualified to interpret mammography by--
  `(i)(I) a board described in paragraph (2)(B); or
  `(II) a program that complies with the standards described in paragraph
  (2)(C); and
  `(ii) meets training and continuing medical education requirements as
  established by the Secretary;
  `(E) a requirement that individuals who survey mammography facilities be
  medical physicists--
  `(i) licensed or approved by a State to perform such surveys, reviews,
  or inspections for mammography facilities;
  `(ii) certified in diagnostic radiological physics or certified as qualified
  to perform such surveys by a board as described in paragraph (2)(D); or
  `(iii) in the first 5 years after the date of the enactment of this section,
  who meet other criteria established by the Secretary which are comparable
  to the criteria described in clause (i) or (ii);
  `(F) a requirement that a medical physicist who is qualified in mammography
  as described in subparagraph (E) survey mammography equipment and oversee
  quality assurance practices at each facility;
  `(G) a requirement that--
  `(i)(I) a facility that performs any mammogram maintain the mammogram in
  the permanent medical records of the patient for a period of not less than
  5 years, or not less than 10 years if no additional mammograms of such
  patient are taken at the facility, or longer if mandated by State law; or
  `(II) until such time as the patient should request that the patient's
  medical records be forwarded to a medical institution or a physician of
  the patient; and
  `(ii)(I) a facility must assure the preparation of a written report of the
  results of the mammography examination signed by the interpreting physician;
  `(II) such written report shall be provided to the patient's referring or
  primary care physician (if any);
  `(III) if such a physician is not available or if there is not such a
  physician, the written report shall be sent directly to the patient; and
  `(IV) if such report is sent to the patient, the report shall include a
  summary written in terms easily understood by a lay person; and
  `(H) standards relating to special techniques for mammography of patients
  with breast implants.
Subparagraph (G) shall not be construed to limit a patient's access to the
patient's medical records.
  `(2) CERTIFICATION OF PERSONNEL- The Secretary shall by regulation--
  `(A) specify organizations eligible to certify individuals to perform
  mammographies, as required by paragraph (1)(C);
  `(B) specify boards eligible to certify physicians to interpret mammograms
  as required by paragraph (1)(D);
  `(C) establish standards regarding the qualifications for physicians
  described in subparagraph (B) for programs certifying the physicians, and
  `(D) specify boards eligible to certify medical physicists who are qualified
  to survey mammography equipment and to oversee quality assurance practices
  at mammography facilities.
  `(g) INSPECTIONS-
  `(1) ANNUAL INSPECTIONS-
  `(A) IN GENERAL- The Secretary may enter and inspect certified facilities
  to determine compliance with the standards established under subsection
  (f). The Secretary may delegate to a State agency the authority to make
  such inspections.
  `(B) IDENTIFICATION- The Secretary, or State agency acting on behalf of
  the Secretary, may conduct inspections only on presenting identification
  to the owner, operator, or agent in charge of the facility to be inspected.
  `(C) SCOPE OF INSPECTION- In conducting inspections, the Secretary or
  State agency acting on behalf of the Secretary--
  `(i) shall have access to all equipment, materials, records, and information
  that the Secretary or State agency considers necessary to determine whether
  the facility is being operated in accordance with this section; and
  `(ii) may copy, or require the facility to submit to the Secretary or the
  State agency, any of the materials, records, or information.
  `(D) ELEMENTS OF INSPECTION- Inspections shall include an inspection of the
  beam quality, average glandular dose, film processing, phantom image quality
  of the mammography system, and other features as determined by the Secretary.
  `(E) QUALIFICATIONS OF INSPECTORS- Qualified individuals, as determined
  by the Secretary, shall conduct all inspections. The Secretary may request
  that a State agency acting on behalf of the Secretary designate a qualified
  officer or employee to conduct the inspections, or designate a qualified
  Federal officer or employee to conduct inspections. The Secretary shall
  establish minimum qualifications and appropriate training for inspectors
  and criteria for certification of inspectors in order to inspect facilities
  for compliance with subsection (f).
  `(F) FREQUENCY- The Secretary or State agency acting on behalf of the
  Secretary shall conduct inspections of each certified facility not less
  often than annually.
  `(G) RECORDS AND ANNUAL REPORTS- The Secretary or a State agency
  acting on behalf of the Secretary which is responsible for inspecting
  mammography facilities shall maintain records of annual inspections
  required under subsection (g) for not less than 7 years after the date of
  the inspection. Such a State agency shall annually prepare and submit to
  the Secretary a report concerning the inspections carried out under this
  paragraph. Such reports shall include a description of the facilities
  inspected and the results of such inspections.
  `(2) INSPECTION OF ACCREDITED FACILITIES- The Secretary shall inspect a
  sufficient number of the facilities accredited by each accreditation body
  to provide the Secretary with a reasonable estimate of the performance of
  such body.
  `(3) INSPECTION OF FACILITIES INSPECTED BY STATE AGENCIES- The Secretary
  shall inspect facilities inspected by State agencies acting on behalf of
  the Secretary to assure a reasonable performance by such State agencies.
  `(4) TIMING- The Secretary, or State agency, may conduct inspections under
  paragraphs (1), (2), and (3) after providing 48 hours of notice unless the
  Secretary waives the notice period or prescribes circumstances under which a
  shorter notice period for visits to a facility would be appropriate because
  the continued performance of mammographies at such facility threatens the
  public health.
  `(h) SANCTIONS-
  `(1) IN GENERAL- The Secretary may, in lieu of taking the actions authorized
  by subsection (i), impose the following sanctions:
  `(A) Directed plans of correction.
  `(B) Payment for the cost of onsite monitoring.
  `(2) CIVIL MONEY PENALTIES- The Secretary may assess civil money penalties
  in an amount not to exceed $10,000 for--
  `(A) failure to obtain a certificate as required by subsection (b),
  `(B) each failure by a facility to substantially comply with, or each
  day on which a facility fails to substantially comply with, the standards
  established under subsection (f) or the requirements described in clauses
  (i) through (iii) of subsection (d)(2)(B), and
  `(C) each violation, or for each aiding and abetting in a violation of,
  any provision of, or regulation promulgated under, this section by an owner,
  operator, or any employee of a facility required to have a certificate.
  `(3) PROCEDURES- The Secretary shall develop and implement procedures
  with respect to when and how each of the sanctions is to be imposed under
  paragraphs (1) and (2). Such procedures shall provide for notice to the owner
  or operator of the facility and a reasonable opportunity for the owner or
  operator to respond to the proposed sanctions and appropriate procedures
  for appealing determinations relating to the imposition of sanctions.
  `(i) SUSPENSION, REVOCATION, AND LIMITATION-
  `(1) IN GENERAL- The certificate of a facility issued under subsection
  (b) may be suspended, revoked, or limited if the Secretary finds, after
  providing, except as provided in paragraph (2), reasonable notice and
  an opportunity for a hearing to the owner or operator of the facility,
  that the owner, operator, or any employee of the facility--
  `(A) has been guilty of misrepresentation in obtaining the certificate;
  `(B) has performed, or represented the facility as entitled to perform,
  a type of examination or procedure described in subparagraphs (A) through
  (C) of subsection (b)(2) that is outside the scope of the certificate for
  the facility;
  `(C) has failed to comply with the requirements of subsection (d)(2)(B)(iii)
  or the standards established by the Secretary under subsection (f);
  `(D) has failed to comply with reasonable requests of the Secretary for
  any record, information, report, or material that the Secretary concludes
  is necessary to determine the continued eligibility of the facility for a
  certificate or continued compliance with the standards established under
  subsection (f);
  `(E) has refused a reasonable request of the Secretary, any Federal officer
  or employee duly designated by the Secretary, or any State officer
  or employee duly designated by the State, for permission to inspect
  the facility or the operations and pertinent records of the facility in
  accordance with subsection (g);
  `(F) has violated or aided and abetted in the violation of any provision
  of, or regulation promulgated under, this section; or
  `(G) has failed to comply with a sanction imposed under subsection (h).
  `(2) ACTION BEFORE A HEARING-
  `(A) IN GENERAL- The Secretary may suspend or limit the certificate of
  the facility before holding a hearing required by paragraph (1) if the
  Secretary makes the finding described in paragraph (1) and determines that--
  `(i) the failure of a facility to comply with the standards established
  by the Secretary under subsection (f) presents an imminent and serious
  risk to human health; or
  `(ii) a facility has engaged in an action described in subparagraph (D)
  or (E) of paragraph (1).
  `(B) HEARING- If the Secretary suspends or limits a certificate under
  subparagraph (A), the Secretary shall provide an opportunity for a
  hearing to the owner or operator of the facility not later than 60 days
  from the effective date of the suspension or limitation. The suspension
  or limitation shall remain in effect until the decision of the Secretary
  made after the hearing.
  `(3) INELIGIBILITY TO OWN OR OPERATE FACILITIES AFTER REVOCATION- If the
  Secretary revokes the certificate of a facility on the basis of an act
  described in paragraph (1), no person who owned or operated the facility at
  the time of the act may, within 2 years of the revocation of the certificate,
  own or operate a facility that requires a certificate under this section.
  `(j) INJUNCTIONS- If the Secretary determines that--
  `(1) continuation of any activity related to the provision of mammography by
  a facility would constitute an imminent and serious risk to human health,
  the Secretary may bring suit in the district court of the United States
  for the district in which the facility is situated to enjoin continuation
  of the activity; and
  `(2) a facility is operating without a certificate as required by subsection
  (b), the Secretary may bring suit in the district court of the United
  States for the district in which the facility is situated to enjoin the
  operation of the facility.
Upon a proper showing, the district court shall grant a temporary injunction
or restraining order against continuation of the activity or against operation
of a facility, as the case may be, without requiring the Secretary to post
a bond, pending issuance of a final order under this subsection.
  `(k) JUDICIAL REVIEW-
  `(1) PETITION- If the Secretary imposes a sanction on a facility under
  subsection (h) or suspends, revokes, or limits the certificate of a facility
  under subsection (i), the owner or operator of the facility may, not later
  than 60 days after the date the action of the Secretary becomes final,
  file a petition with the United States court of appeals for the circuit
  in which the facility is situated for judicial review of the action. As
  soon as practicable after receipt of the petition, the clerk of the court
  shall transmit a copy of the petition to the Secretary or other officer
  designated by the Secretary. As soon as practicable after receipt of the
  copy, the Secretary shall file in the court the record on which the action
  of the Secretary is based, as provided in section 2112 of title 28, United
  States Code.
  `(2) ADDITIONAL EVIDENCE- If the petitioner applies to the court for leave
  to adduce additional evidence, and shows to the satisfaction of the court
  that the additional evidence is material and that there were reasonable
  grounds for the failure to adduce such evidence in the proceeding before
  the Secretary, the court may order the additional evidence (and evidence
  in rebuttal of the additional evidence) to be taken before the Secretary,
  and to be adduced upon the hearing in such manner and upon such terms
  and conditions as the court may determine to be proper. The Secretary may
  modify the findings of the Secretary as to the facts, or make new findings,
  by reason of the additional evidence so taken, and the Secretary shall file
  the modified or new findings, and the recommendations of the Secretary,
  if any, for the modification or setting aside of the original action of
  the Secretary with the return of the additional evidence.
  `(3) JUDGMENT OF COURT- Upon the filing of the petition referred to in
  paragraph (1), the court shall have jurisdiction to affirm the action, or to
  set the action aside in whole or in part, temporarily or permanently. The
  findings of the Secretary as to the facts, if supported by substantial
  evidence, shall be conclusive.
  `(4) FINALITY OF JUDGMENT- The judgment of the court affirming or setting
  aside, in whole or in part, any action of the Secretary shall be final,
  subject to review by the Supreme Court of the United States upon certiorari
  or certification, as provided in section 1254 of title 28, United States
  Code.
  `(l) FEES- The Secretary shall, as part of the delegation to a State
  agency of inspection authority, limit the amount of fees which such State
  agency may impose for inspections to the costs of the State to make such
  inspections. The Secretary shall issue regulations establishing criteria
  for the establishment of fees by a State agency acting on behalf of the
  Secretary.
  `(m) INFORMATION-
  `(1) IN GENERAL- Not later than July 1, 1996, and annually thereafter, the
  Secretary shall compile and make available to physicians and the general
  public information that the Secretary determines is useful in evaluating
  the performance of a facility, including a list of facilities--
  `(A) that have been convicted under Federal or State laws relating to
  fraud and abuse, false billings, or kickbacks;
  `(B) that have been subject to sanctions under subsection (h), together
  with a statement of the reasons for the sanctions;
  `(C) that have had certificates revoked, suspended, or limited under
  subsection (i), together with a statement of the reasons for the revocation,
  suspension, or limitation;
  `(D) against which the Secretary has taken action under subsection (j),
  together with a statement of the reasons for the action;
  `(E) whose accreditation has been withdrawn or revoked, together with a
  statement of the reasons of the withdrawal or revocation; and
  `(F) that meets such other measures of performance as the Secretary may
  develop.
  `(2) DATE- The information to be compiled under paragraph (1) shall be
  information for the calendar year preceding the date the information is
  to be made available to the public.
  `(3) EXPLANATORY INFORMATION- The information to be compiled under
  paragraph (1) shall be accompanied by such explanatory information as may
  be appropriate to assist in the interpretation of the information compiled
  under such paragraph.
  `(n) STATE AND LOCAL LAWS- Nothing in this section shall be construed as
  affecting the power of any State or locality to enact and enforce laws
  relating to the matters covered by this section to the extent that the
  laws are not in conflict with this section or with the regulations issued
  under this section.
  `(o) NATIONAL ADVISORY COMMITTEE-
  `(1) ESTABLISHMENT- In carrying out this section, the Secretary shall
  establish an advisory committee to be known as the National Mammography
  Quality Assurance Advisory Committee (hereafter in this subsection referred
  to as the `Advisory Committee').
  `(2) COMPOSITION- The Advisory Committee shall be composed of not fewer
  than 18, nor more than 24 individuals, who are not officers or employees
  of the Federal Government. The Secretary shall make appointments to the
  Advisory Committee from among--
  `(A) physicians,
  `(B) practitioners, and
  `(C) other health professionals,
whose clinical practice, research specialization, or professional expertise
include a significant focus on mammography. The Secretary shall appoint at
least 5 individuals from among national breast cancer or consumer health
organizations with expertise in mammography.
  `(3) FUNCTIONS AND DUTIES- The Advisory Committee shall--
  `(A) advise the Secretary on appropriate quality standards and regulations
  for mammography facilities;
  `(B) advise the Secretary on appropriate standards and regulations for
  accreditation bodies;
  `(C) advise the Secretary in the development of regulations with respect
  to sanctions;
  `(D) assist in developing procedures for monitoring compliance with
  standards under subsection (f);
  `(E) make recommendations and assist in the establishment of a mechanism
  to investigate consumer complaints;
  `(F) report on new developments concerning breast imaging that should be
  considered in the oversight of mammography facilities; and
  `(G) perform other activities that the Secretary may require.
  `(4) MEETINGS- The Advisory Committee shall meet not less than quarterly
  for the first 3 years of the program and thereafter, at least biannually.
  `(5) CHAIRPERSON- The Secretary shall appoint a chairperson of the Advisory
  Committee.
  `(p) CONSULTATIONS- In carrying out this section, the Secretary shall consult
  with appropriate Federal agencies for the purposes of developing standards,
  regulations, evaluations, and procedures for compliance and oversight.
  `(q) BREAST CANCER SCREENING SURVEILLANCE RESEARCH GRANTS-
  `(1) RESEARCH-
  `(A) GRANTS- The Secretary shall award grants to such entities as the
  Secretary may determine to be appropriate to establish surveillance systems
  in selected geographic areas to provide data to evaluate the functioning
  and effectiveness of breast cancer screening programs in the United States,
  including assessments of participation rates in screening mammography,
  diagnostic procedures, incidence of breast cancer, mode of detection
  (mammography screening or other methods), outcome and follow up information,
  and such related epidemiologic analyses that may improve early cancer
  detection and contribute to reduction in breast cancer mortality. Such
  information systems should include information concerning the techniques
  for the practical application of, and compliance with such surveillance
  systems. Grants may be awarded for further research on breast cancer
  surveillance systems upon the Secretary's review of the evaluation of
  the program.
  `(B) USE OF FUNDS- Grants awarded under subparagraph (A) may be used--
  `(i) to study--
  `(I) methods to link mammography and clinical breast examination records
  with population-based cancer registry data;
  `(II) methods to provide diagnostic outcome data, or facilitate the
  communication of diagnostic outcome data, to radiology facilities for
  purposes of evaluating patterns of mammography interpretation; and
  `(III) mechanisms for limiting access and maintaining confidentiality of
  all stored data; and
  `(ii) to conduct pilot testing of the methods and mechanisms described in
  subclauses (I), (II), and (III) of clause (i) on a limited basis.
  `(C) GRANT APPLICATION- To be eligible to receive funds under this paragraph,
  an entity shall submit an application to the Secretary at such time,
  in such manner, and containing such information as the Secretary may require.
  `(D) REPORT- A recipient of a grant under this paragraph shall submit a
  report to the Secretary containing the results of the study and testing
  conducted under clauses (i) and (ii) of subparagraph (B), along with
  recommendations for methods of establishing a breast cancer screening
  surveillance system.
  `(2) ESTABLISHMENT- The Secretary shall establish a breast cancer screening
  surveillance system based on the recommendations contained in the report
  described in paragraph (1)(D).
  `(3) STANDARDS AND PROCEDURES- The Secretary shall establish standards and
  procedures for the operation of the breast cancer screening surveillance
  system, including procedures to maintain confidentiality of patient records.
  `(4) INFORMATION- The Secretary may require that facilities provide to
  the breast cancer screening surveillance system relevant data that could
  help in the research of the causes, characteristics, and prevalence of,
  and potential treatments for, breast cancer and benign breast conditions,
  if the information may be disclosed under section 552 of title 5, United
  States Code.
  `(r) AUTHORIZATION OF APPROPRIATIONS- There are authorized to be appropriated
  to carry out this section--
  `(1) to award research grants under subsection (q), $1,200,000 for each
  of the fiscal years 1993 through 1997; and
  `(2) to carry out other activities which are not supported by fees
  authorized and collected under subsection (l), $2,500,000 for fiscal year
  1993, $12,000,000 for fiscal year 1994, and such sums as may be necessary
  for each of the fiscal years 1995, 1996, and 1997.'.
HR 5938 RH----2
HR 5938 RH----3