law, the Secretary shall use the standard patient as-
sessment instruments established under this sub-
section in determining payments amounts under this
title for items and services.
‘‘(e) REQUIREMENTS FOR QUALITY IMPROVEMENT
ORGANIZATIONS.—The Secretary shall enter into agree-
ments with quality improvement organizations to carry out
the following functions:
‘‘(1) IMPLEMENTATION OF DATA COLLECTION
SYSTEM.—To implement a standard data collection
system established by the Secretary to collect—
‘‘(A) mandatory reports from providers
and suppliers on serious preventable adverse
events (as determined by the Secretary in regu-
lations);
‘‘(B) voluntary reports of near misses (as
determined by the Secretary in regulations),
clinical systems problems, or other failures to
meet quality or safety standards or performance
standards;
‘‘(C) reports of investigations of root
causes of serious preventable adverse events
and near misses;
‘‘(D) corrective actions taken to address
identified quality and safety problems;
‘‘(E) data and information obtained in con-
ducting sampling of medical records and other
investigations of medical care;
‘‘(F) data on performance of providers and
suppliers in achieving quality standards and
performance measures; and
‘‘(G) such other information as the Sec-
retary determines appropriate.
‘‘(2) REMOVAL
FROM
DATA
OF
PERSONALLY
IDENTIFIABLE INFORMATION.—To modify the data
received to remove identification of patients, pro-
viders or suppliers, and reporters of the information,
and to enter the information into a database.
‘‘(3) INVESTIGATIONS OF ADVERSE EVENTS.—
To investigate serious preventable adverse events at
providers and suppliers as reported through the
mandatory reporting system.
‘‘(4) ASSISTANCE
WITH
CORRECTIVE
ACTION
PLANS.—To assist providers and suppliers to imple-
ment appropriate corrective action plans in response
to identification of serious preventable adverse
events.
‘‘(5) DISSEMINATION OF INFORMATION TO PRO-
VIDERS.—To provide dissemination of information
and ongoing training to providers and suppliers re-
garding quality and safety standards, performance
measures, best practices, analyses of information re-
garding quality or safety, and other quality and
safety improvement information.
‘‘(6) FORUMS FOR DISCUSSIONS OF BEST PRAC-
TICES AND MEDICAL ERRORS.—To provide a means
of convening of providers and suppliers to discuss
medical errors, failures to achieve quality or safety
standards, performance measures, best practices,
lessons learned by other providers and suppliers, and
other quality and safety issues.
‘‘(7) REVIEW OF MEDICAL RECORDS.—To con-
duct ongoing sampling and clinical data abstraction
of medical records of providers and suppliers and
data submitted by providers and suppliers on patient
assessment instruments to identify quality and safe-
ty problems and opportunities for improvement.
‘‘(8) ANALYSIS OF DATA.—To conduct analyses
of the data included in the database to identify
issues indicating quality or safety problems, needed
systems changes, and opportunities for improvement.
‘‘(9) FEEDBACK
TO
PROVIDERS.—To provide
ongoing feedback to providers, suppliers, and other
individuals regarding reports, lessons learned from
reports, investigations, and corrective actions.
‘‘(10) PROTECTING PERSONALLY IDENTIFIABLE
INFORMATION.—The provisions of section 1160 (re-
lating to prohibition against disclosure of informa-
tion) apply with respect to data or information on
adverse events reported to quality improvement or-
ganizations under this section, including such infor-
mation disseminated or discussed as provided for
under this subsection, in the same manner as such
provisions apply to information data or information
acquired by such an organization in the exercise of
its duties and functions under section 1160.
‘‘(11) MAINTENANCE OF A TOLL-FREE TELE-
PHONE NUMBER.—To provide information via a toll-
free telephone number.
‘‘(f) REQUIREMENTS
FOR PROVIDERS
AND SUP-
PLIERS.—Providers and suppliers furnishing items and
services under this title shall establish and maintain a
Medicare Quality and Safety Program, which shall include
the following elements:
‘‘(1) CHIEF MEDICAL QUALITY AND SAFETY OF-
FICER.—Designation of a senior level Chief Medical
Quality and Safety Officer.
‘‘(2) 
WRITTEN
STANDARDS
OF
QUALITY
CARE.—Written standards for quality of care and
patient and employee safety, including error preven-
tion, consistent with those promulgated by the Sec-
retary under subsection (b)(2), and policies and pro-
cedures for implementing those standards, including
disciplinary standards.
‘‘(3) WRITTEN
STANDARDS
FOR
PATIENTS
CARE.—Written standards for patient assessment,
preparation of a plan of care for each patient (in-
cluding participation of the patient in clinical deci-
sion making), coordination of services among all
those providing services for the patient, monitoring
of quality, safety, and patient improvement, and
records management.
‘‘(4) ONGOING
EDUCATION
AND
TRAINING.—
Ongoing conduct of effective education and training
of employees regarding quality and safety, including
the prevention of errors.
‘‘(5) ONGOING MONITORING AND REPORTING.—
Ongoing monitoring and internal reporting of med-
ical quality and safety, including monitoring and re-
porting of serious preventable adverse events.
‘‘(6) 
PROMPT
DISCUSSION
OF
ADVERSE
EVENTS.—Prompt discussion with patients of ad-
verse events, including adverse events that result
from errors, and providing access to the patients of
information relating to such events.
‘‘(7) PROMPT
REPORTING
OF
MEDICAL
ER-
RORS.—Prompt reporting (as determined by the
Secretary) to the quality improvement organizations
of serious preventable adverse events, including ad-
verse events that result from errors, using standard
formats promulgated by the Secretary, and including
encouragement of reporting by employees.
‘‘(8) COOPERATION
IN
CASE
OF
INVESTIGA-
TIONS.—Cooperation with the quality improvement
organizations in investigating causes of serious pre-
ventable adverse events, including adverse events
that result from errors, near misses, or other inves-
tigations of quality or safety.
‘‘(9) COOPERATION IN DEVELOPMENT OF COR-
RECTIVE
ACTION
PLANS.—Cooperation with the
quality improvement organizations in developing cor-
rective action plans to address a serious preventable
adverse event, including an adverse event that re-
sults from an error, or a corrective action plan to
address other quality or safety problems.
‘‘(10) COOPERATION
IN
PREPARING
ANNUAL
REPORTS.—Cooperation with the quality improve-
ment organizations in preparing public annual re-
ports on progress in meeting quality and safety
standards and performance measures, as determined
by the Secretary.
Notwithstanding any other provision of law, a provider or
supplier may report adverse events, including those result-
ing from errors, as provided under this section without
the consent of the individual who was furnished the med-
ical care which gave rise to the adverse event.
‘‘(g) WHISTLEBLOWER PROTECTIONS.—A provider
of services or supplier may not penalize or take adverse
action against an employee because the employee reports
an adverse event to a quality improvement organization,
or submits data or information to the Secretary with re-
spect to the quality of items or services furnished under
this title by such provider or supplier, consistent with the
requirements of this section.
‘‘(h) MEDICARE QUALITY AND SAFETY ADVISORY
COMMITTEE.—
‘‘(1) ESTABLISHMENT.—The Secretary shall es-
tablish the Medicare Quality Advisory Committee
(hereinafter in this subsection referred to as the
‘Committee’). The Secretary shall consult with the
Committee, and may consult directly with any panel
that the Committee establishes.
‘‘(2) DUTIES.—The Committee, and its panels,
shall provide advice and recommendations to the
Secretary with respect to—
‘‘(A) the quality and safety of medical care
furnished to individuals entitled to benefits
under this title, including such individuals en-
rolled in Medicare+Choice plans under part C
of this title;
‘‘(B) establishment of goals and specific
annual objectives with respect to such quality
and safety; and
‘‘(C) other issues relating to such quality
and safety, including—
‘‘(i) reporting and collection of data,
‘‘(ii) appropriate research and anal-
ysis of data,
‘‘(iii) quality and safety standards,
performance measures, and best practices,
‘‘(iv) dissemination of information to
beneficiaries on treatment options,
‘‘(v) dissemination of information on
quality of care and safety to providers and
suppliers, and
‘‘(vi) such other quality of care and
safety issues as the Committee may con-
sider appropriate, or of which as the Sec-
retary requests recommendations.
‘‘(3) MEMBERSHIP; TERMS; COMPENSATION.—
‘‘(A) MEMBERSHIP.—
‘‘(i) NUMBER
AND
APPOINTMENT.—
The Commission shall be composed of 17
members, of whom 14 shall be appointed
in accordance with clause (ii) and 3 ap-
pointed in accordance with in clause (iii).
‘‘(ii) PRIVATE INDIVIDUALS.—
‘‘(I) IN
GENERAL.—The Sec-
retary shall appoint 14 members from
among individuals who are qualified
by training and experience to evaluate
the matters referred to the Committee
and who are not officers or employees
of the United States.
‘‘(II) PROVISIONS FOR CONFLICT
OF INTEREST.—Members shall recuse
themselves from participation in mat-
ters which present a potential per-
sonal conflict of interest or appear-
ance of such conflict that might intro-
duce bias in the process of making
recommendations 
under 
this 
sub-
section.
‘‘(iii) 
INDIVIDUALS
REPRESENTING
ORGANIZATIONS.—The Secretary shall ap-
point one member from each of the fol-
lowing organizations:
‘‘(I) The Medicare Coverage Ad-
visory Committee.
‘‘(II) A quality improvement or-
ganization.
‘‘(III) The National Advisory
Council for Healthcare Research and
Quality.
‘‘(B) TERMS.—
‘‘(i) IN
GENERAL.—Members of the
Committee appointed under subparagraph
(A) shall serve for a term of 3 years.
‘‘(ii) STAGGERED TERMS.—To ensure
the staggered rotation of one-third of the
members of the Committee each year, the
Secretary is authorized to appoint the ini-
tial members of the Committee for terms
of 1, 2, or 3 years.
‘‘(iii) SERVICE
BEYOND
TERM.—A
member of the Committee appointed under
subparagraph (A) may continue to serve
after the expiration of the term of the
members until a successor is appointed.
‘‘(iv) VACANCIES.—If a member of
the Advisory Council appointed under sub-
paragraph (A) does not serve the full term
applicable under this subparagraph, the in-
dividual appointed to fill the resulting va-
cancy shall be appointed for the remainder
of the term of the predecessor of the indi-
vidual.
‘‘(v) CHAIR.—The Secretary shall,
from among the members of the Com-
mittee 
appointed 
under 
subparagraph
(A)(ii), designate an individual to serve as
the chair of the Committee.
‘‘(C) COMPENSATION.—
‘‘(i) PRIVATE
INDIVIDUALS.—Mem-
bers of the Committee appointed under
subparagraph (A)(ii) shall receive com-
pensation for each day (including travel
time) engaged in carrying out the duties of
the Advisory Council unless declined by the
member. Such compensation may not be in
an amount in excess of the daily equivalent
of the annual rate of basic pay prescribed
for level IV of the Executive Schedule
under section 5315 of title 5, United
States Code, for each day during which
such member is engaged in the perform-
ance of the duties of the Advisory Council.
‘‘(ii) INDIVIDUALS REPRESENTING OR-
GANIZATIONS.—Members appointed under
subparagraph (A)(iii) may not receive com-
pensation for service on the Committee in
addition to the compensation otherwise re-
ceived for duties carried out as members of
the organization.
‘‘(4) REPORT.—
‘‘(A) ANNUAL
REPORT
TO
THE
SEC-
RETARY.—Not later than May 1 of every year
beginning with 2002, the Committee shall sub-
mit to the Secretary a report on—
‘‘(i) the activities of the Committee
during the preceding year;
‘‘(ii) progress by providers of services
and suppliers in meeting goals and objec-
tives for improvement of the quality of
items and services furnished under this
title during such fiscal year; and
‘‘(iii) any recommendation of the
Committee with respect to quality of care
issues under this title.
‘‘(B) PUBLICATION OF REPORT.—Not later
than 60 days after receipt of the report under
subparagraph (A), the Secretary shall publish
the report, together with any supplemental
views of the Secretary, on the Internet site of
the Department of Health and Human Services.
‘‘(5) DURATION.—Section 14(a)(2)(B) of the
Federal Advisory Committee Act (5 U.S.C. App.; re-
lating to the termination of advisory committees)
shall not apply to the Committee.
‘‘(i) REPORT TO CONGRESS.—The Secretary shall
submit to Congress an annual report on the progress of
providers and suppliers in meeting the goals and objectives
for improving quality of medical care and safety for indi-
viduals entitled to benefits under this title.
‘‘(j) DEFINITIONS.—In this section:
‘‘(1) ADVERSE
EVENT.—The term ‘adverse
event’ means an unintended effect of medical inter-
vention that results in harm to a patient.
‘‘(2) PREVENTABLE
ADVERSE
EVENT.—The
term ‘preventable adverse event’ means an adverse
event that is preventable, including those that result
from errors.’’.
(2) EFFECTIVE DATE.—The amendment made
by paragraph (1) shall apply to items and services
furnished on or after—
(A) in the case of a hospital, rehabilitation
unit, or end stage renal disease provider, Octo-
ber 1, 2001; and
(B) in the case of any other provider or
supplier, at such time as the Secretary deter-
mines appropriate, but in no event earlier than
October 1, 2001.
(3) CONFORMING AMENDMENTS.—
(A) CONSULTATION
WITH
STATE
AGEN-
CIES.—(i) Section 1864 of the Social Security
Act (42 U.S.C. 1395aa) is amended by adding
at the end the following new subsection:
‘‘(f) In carrying out functions, relating to determina-
tion of conditions of participation by providers of services,
under subsections (e)(9), (f)(4), (j)(15), (o)(6), (cc)(2)(I),
and (dd)(2) of section 1861, or by ambulatory surgical
centers under section 1832(a)(2)(F)(i), the Secretary shall
consult with appropriate State agencies and recognized
national listing or accrediting bodies, and may consult
with appropriate local agencies. Such conditions pre-
scribed under any of such subsections may be varied for
different areas or different classes of institutions or agen-
cies and may, at the request of a State, provide higher
requirements for such State than for other States; except
that, in the case of any State or political subdivision of
a State which imposes higher requirements on institutions
as a condition to the purchase of services (or of certain
specified services) in such institutions under a State plan
approved under title I, XVI, or XIX, the Secretary shall
impose like requirements as a condition to the payment
for services (or for the services specified by the State or
subdivision) in such institutions in such State or subdivi-
sion.’’.
(ii) The heading to such section is amended by
adding at the end the following:
‘‘CONSULTATION WITH STATE AGENCIES AND OTHER OR-
GANIZATIONS TO DEVELOP CONDITIONS OF PARTICI-
PATION FOR PROVIDERS OF SERVICES’’.
(B) CHIEF MEDICARE QUALITY AND SAFE-
TY OFFICER.—Section 1117 of the Social Secu-
rity Act (42 U.S.C. 1317) is amended—
(i) in the heading, by striking ‘‘AND
CHIEF ACTUARY’’ and inserting ‘‘, CHIEF
ACTUARY, AND CHIEF MEDICARE QUALITY
AND SAFETY OFFICER’’; and
(ii) by adding at the end the fol-
lowing:
‘‘(c)(1) There is established in the Health Care Fi-
nancing Administration the position of Chief Medicare
Quality and Safety Officer. The Chief Medicare Quality
and Safety Officer shall be appointed by, and in direct
line of authority to, the Administrator of such Administra-
tion. The Chief Medicare Quality and Safety Officer shall
be appointed from among individuals who have dem-
onstrated, by their education and experience, superior ex-
pertise in the quality in the delivery of health care services.
The Chief Medicare Quality and Safety Officer shall exer-
cise such duties as are appropriate for the office of the
Chief Medicare Quality and Safety Officer. The Chief
Medicare Quality and Safety Officer may be removed only
for cause.
‘‘(2) The Chief Medicare Quality and Safety Officer
shall be compensated at the highest rate of basic pay for
the Senior Executive Service under section 5382(b) of title
5, United States Code.’’.
(b) AGREEMENTS
WITH
PROVIDERS
AND
SUP-
PLIERS.—
(1) IN GENERAL.—Section 1866(a)(1) of the
Social Security Act (42 U.S.C. 1395cc(a)(1)) is
amended—
(A) at the end of subparagraph (R) by
striking ‘‘and’’;
(B) at the end of subparagraph (S) by
striking the period and inserting ‘‘, and’’; and
(C) by inserting after subparagraph (S)
the following new subparagraph:
‘‘(T) to carry out requirements with respect to
comprehensive quality of medical care and safety for
items and services furnished to individuals entitled
to benefits under this title imposed under section
1863, in such manner and within such timeframes
as the Secretary establishes in regulations, including
prompt reporting of medical errors to the Secretary
or to quality improvement organizations.’’.
(2) EFFECTIVE DATE.—The amendments made
by paragraph (1) shall apply to items and services
furnished on or after—
(A) in the case of a hospital, rehabilitation
unit, or end stage renal disease provider, Octo-
ber 1, 2001; and
(B) in the case of any other provider or
supplier, at such time as the Secretary deter-
mines appropriate, but in no event earlier than
October 1, 2001.
(c) REDESIGNATION OF PEER REVIEW ORGANIZA-
TION AS QUALITY IMPROVEMENT ORGANIZATION.—
(1) UTILIZATION AND QUALITY CONTROL PEER
REVIEW ORGANIZATION.—
(A) IN GENERAL.—The following sections
of the Social Security Act are each amended by
striking ‘‘utilization and quality control peer re-
view organization’’ each place it appears and in-
serting ‘‘quality improvement organization’’:
(i) 
TITLE
XI.—1128A(h), 
1151,
1153(b)(1), 
the 
second 
sentence 
of
1153(c), 1153(d)(3), 1153(d)(4), 1154(a),
1154(c), 1154(d), 1156(c), 1158(a), and
1161(a)(1) 
(42 
U.S.C. 
1320a–7a(h),
1320c, 1320c–2(b)(1), 1320c–2(c), 1320c–
2(d)(3), 
1320c–2(d)(4), 
1320c–3(a),
1320c–3(c), 
1320c–3(d), 
1320c–5(c),
1320c–7(a), 1320c–10(a)(1), respectively).
(ii) 
TITLE
XVIII.—1862(a)(15)(A),
1862(g), 
1866(a)(1)(F)(i),
1866(a)(1)(F)(ii), 
1867(d)(3),
1876(i)(7)(A), 1879(a), and 1886(f)(2)
(42 U.S.C. 1395y(a)(15)(A), 1395y(g),
1395cc(a)(1)(F)(i), 
1395cc(a)(1)(F)(ii),
1395dd(d)(3), 
1395mm(i)(7)(A),
1395pp(a), 
and 
1395ww(f)(2) 
respec-
tively).
(iii) 
TITLE
XIX.—1902(d),
1903(a)(3)(C)(i), and section 1921(b)(4)
(42 U.S.C. 1396a(d), 1396b(a)(3)(C)(i),
and 1396r–2(b)(4), respectively).
(B) HEADINGS.—The headings of the fol-
lowing sections of title XI of the Social Security
Act are each amended by striking ‘‘UTILIZA-
TION AND QUALITY CONTROL PEER REVIEW OR-
GANIZATION’’ each place it appears and insert-
ing ‘‘QUALITY IMPROVEMENT ORGANIZATION’’:
1152, 1153, and 1163 (42 U.S.C. 1320c–1,
1320c–2, and 1320c–12, respectively).
(2) PEER
REVIEW
ORGANIZATION.—The fol-
lowing sections of the Social Security Act are each
amended by striking ‘‘peer review organization’’ each
place it appears and inserting ‘‘quality improvement
organization’’:
(A) TITLE
XI.—1153(e)(2), 1153(h)(3),
1154(a)(2)(B), 
1154(a)(3)(E)(i),
1154(a)(4)(A), 
1154(a)(4)(C), 
1154(e)(2),
1154(e)(3)(A)(ii), 
1154(e)(3)(B),
1154(e)(4)(B), 
1155, 
1156(a)(3), 
and
1160(b)(1) (42 U.S.C. 1320c–2(e)(2), 1320c–
2(h)(3), 
1320c–3(a)(2)(B), 
1320c–
3(a)(3)(E)(i), 
1320c–3(a)(4)(A), 
1320c–
3(a)(4)(C), 
1320c–3(e)(2), 
1320c–
3(e)(3)(A)(ii), 
1320c–3(e)(3)(B), 
1320c–
3(e)(4)(B), 
1320c–4, 
1320c–5(a)(3), 
and
1320c–9(b)(1), respectively).
(B) 
TITLE
XVIII.—1820(c)(2)(B)(iii),
1820(d)(2)(C)(ii), 
1842(l)(1)(A)(iii)(I),
1842(l)(2), and 1866(a)(3) (42 U.S.C. 1395i–
4(c)(2)(B)(iii), 
1395i–4(d)(2)(C)(ii),
1395u(l)(1)(A)(iii)(I), 
1395u(l)(2), 
and
1395cc(a)(3), respectively).
(C) TITLE
XIX.—1921(a)(1) (42 U.S.C.
1396r–2(a)(1)).
(3) PEER REVIEW ORGANIZATIONS.—
(A) 
IN
GENERAL.—Sections 
1151,
1153(g), 1154(a)(10)(B), and 1154(f) of the
Social Security Act (42 U.S.C. 1320c, 1320c–
2(g), and 1320c–3(a)(10)(B), respectively) are
each amended by striking ‘‘peer review organi-
zations’’ each place it appears and inserting
‘‘quality improvement organizations’’.
(B) HEADINGS.—The headings of sections
1154 and 1867(d)(3) of the Social Security Act
(42 U.S.C. 1320c–3 and 1395dd, respectively)
are each amended by striking ‘‘PEER REVIEW
ORGANIZATIONS’’ and inserting ‘‘QUALITY IM-
PROVEMENT ORGANIZATIONS’’.
(4) QUALITY CONTROL AND PEER REVIEW OR-
GANIZATION.—The following sections of title XVIII
of the Social Security Act are each amended by
striking ‘‘quality control and peer review organiza-
tion’’ each place it appears and inserting ‘‘quality
improvement 
organization’’: 
1815(b),
1832(a)(2)(F)(ii)(I), 1861(v)(1)(G)(i), 1861(w)(2),
and 
1879(e) 
(42 
U.S.C. 
1395g(b),
1395k(a)(2)(F)(ii)(I), 
1395x(v)(1)(G)(i),
1395x(w)(2), and 1395pp, respectively).
(5) REFERENCES.—Any reference in a law, reg-
ulation, document, paper, or other record of the
United States to a ‘‘peer review organization’’, ‘‘uti-
lization and quality control peer review organiza-
tion’’, or ‘‘quality control and peer review organiza-
tion’’ under part B of title XI of the Social Security
Act shall be deemed to be a reference to a ‘‘quality
improvement organization’’ under such part.
(d) ADDITIONAL PROVISIONS REGARDING QUALITY
IMPROVEMENT ORGANIZATIONS.—
(1) EXPANSION OF QUALITY REVIEW AUTHOR-
ITY TO ALL PROVIDERS AND SUPPLIERS.—
(A) IN GENERAL.—Section 1154 of the So-
cial Security Act (42 U.S.C. 1320c–3) is
amended by adding at the end the following
new subsection:
‘‘(g) In this section, the terms ‘providers of health
care services’ and ‘provider’ includes suppliers of items
under title XVIII and Medicare+Choice organizations of-
fering Medicare+Choice plans under part C of such title.
(B) EXPANSION OF CATEGORY OF SERV-
ICES
FOR
WHICH
REVIEW
MAY
BE
RE-
QUESTED.—Section 1154(e) of the Social Secu-
rity Act (42 U.S.C. 1320c–3(e)) is amended—
(i) in paragraph (1)(A)—
(I) by striking ‘‘hospital’’ and in-
serting ‘‘provider’’; and
(II) by striking ‘‘inpatient hos-
pital care’’ and inserting ‘‘items or
services furnished’’;
(ii) in paragraph (1)(B) by striking
‘‘hospital’s’’ and inserting ‘‘provider’s’’;
(iii) in the matter following subpara-
graph (B) of paragraph (1), by striking
‘‘hospital’’ and inserting ‘‘provider’’;
(iv) in paragraph (2)(A)—