I

106TH CONGRESS

2D SESSION H. R. 5404

To amend title XVIII of the Social Security Act to establish and implement

a comprehensive system under the Medicare Program to assure quality

of care furnished to medicare beneficiaries, and reduce the incidence

of medical errors, and for other purposes.

IN THE HOUSE OF REPRESENTATIVES

OCTOBER 5, 2000

Mr. STARK (for himself, Mr. NEAL of Massachusetts, Mr. JEFFERSON, and

Mr. COYNE) introduced the following bill; which was referred to the Committee on Ways and Means, and in addition to the Committee on Commerce, for a period to be subsequently determined by the Speaker, in

each case for consideration of such provisions as fall within the jurisdiction of the committee concerned

A BILL

To amend title XVIII of the Social Security Act to establish

and implement a comprehensive system under the Medicare Program to assure quality of care furnished to

medicare beneficiaries, and reduce the incidence of medical errors, and for other purposes.

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled,

3 SECTION 1. SHORT TITLE.

4 This Act may be cited as the ‘‘Medicare Comprehen5 sive Quality of Care and Safety Act of 2000’’.
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1 SEC. 2. ESTABLISHMENT OF MEDICARE COMPREHENSIVE

2 QUALITY OF CARE AND SAFETY SYSTEM.

3 (a) MEDICARE COMPREHENSIVE QUALITY OF

4 CARE.—

5 (1) IN GENERAL.—Section 1863 of the Social

6 Security Act (42 U.S.C. 1395z) is amended to read

7 as follows:

8 ‘‘COMPREHENSIVE QUALITY OF CARE AND SAFETY

9 ‘‘SEC. 1863. (a) COMPREHENSIVE QUALITY OF CARE

10 AND SAFETY SYSTEM.—

11 ‘‘(1) ESTABLISHMENT OF SYSTEM.—The Sec12 retary shall establish and maintain a comprehensive

13 quality of care and safety system for improving and

14 monitoring the quality of care and safety of medical

15 care furnished to individuals entitled to benefits

16 under this title and for reducing medical errors and

17 protecting the safety of such individuals in their

18 care. In establishing and maintaining the com19 prehensive quality of care and safety system in this

20 paragraph, the Secretary shall—

21 ‘‘(A) consult with the Medicare Quality

22 Advisory Committee established in subsection

23 (h);

24 ‘‘(B) perform the functions described in

25 this section and such other functions as the

26 Secretary determines appropriate in achieving
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1 quality of care and protecting the safety of indi2 viduals entitled to benefits under this title;

3 ‘‘(C) coordinate and, to the extent prac4 ticable, ensure consistency between the quality

5 of care activities in this section and other qual6 ity of care activities under this title and title

7 XI, including those for Medicare+Choice plans

8 under part C of this title; and

9 ‘‘(D) coordinate all medicare quality of

10 care activities with other quality of care activi11 ties being conducted within the Department of

12 Health and Human Services.

13 ‘‘(2) CHIEF MEDICARE QUALITY AND SAFETY

14 OFFICER.—The Secretary shall appoint a Chief

15 Medicare Quality and Safety Officer to oversee the

16 comprehensive quality of care and safety system in

17 this section and other quality of care activities in

18 this title and title XI.

19 ‘‘(b) QUALITY AND SAFETY IMPROVEMENT.—

20 ‘‘(1) ESTABLISHMENT OF SYSTEM.—The Sec21 retary shall establish a system to achieve continuous

22 quality and safety improvement in the delivery of

23 medical care to individuals entitled to benefits under

24 this title.
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1 ‘‘(2) GOALS AND OBJECTIVES.—The Secretary

2 shall establish goals and specific annual objectives

3 for achieving continuous quality and safety improve4 ments in the delivery of medical care to individuals

5 entitled to benefits under this title, including annual

6 goals and specific objectives for—

7 ‘‘(A) types of providers and suppliers of

8 services;

9 ‘‘(B) categories of individuals entitled to

10 benefits under this title, such as racial, gender,

11 and socioeconomic categories;

12 ‘‘(C) types of services, such as specific pre13 ventive services and other specific services; and

14 ‘‘(D) such other categories as the Sec15 retary determines appropriate and beneficial.

16 ‘‘(3) COMMON SETS OF MEASUREMENTS.—The

17 Secretary shall establish common sets of quality and

18 safety standards, performance measures, and best

19 practices for each type of provider and supplier and

20 type of service affecting quality and safety of both

21 individuals receiving care and employees of providers

22 and suppliers in providing that care. In establishing

23 such quality and safety standards, performance

24 measures, and best practices, the Secretary shall—
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1 ‘‘(A) collect information concerning quality

2 and safety standards, performance measures,

3 and best practices from private sector organiza4 tions and individuals and other governmental

5 organizations and individuals;

6 ‘‘(B) fund research as appropriate to de7 velop knowledge and understanding of quality

8 of care, patient safety, and medical errors to

9 gain insight into better system design to im10 prove quality and safety, and to develop quality

11 and safety standards and performance meas12 ures; and

13 ‘‘(C) establish and maintain a national

14 clearinghouse of quality and safety standards,

15 performance measures, and best practices.

16 ‘‘(c) MONITORING QUALITY OF CARE AND SAFETY.—

17 ‘‘(1) DATA COLLECTION.—The Secretary shall

18 establish such data collection systems and collect

19 such data as may be necessary on an ongoing basis

20 to monitor the quality of care and safety of care pro21 vided to individuals entitled to benefits under this

22 title, and the safety of employees of providers and

23 suppliers who provide that care. Such data collection

24 systems shall include—
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1 ‘‘(A) assessments of health and functional

2 status of individuals receiving care;

3 ‘‘(B) measures of appropriate use and out4 comes of care provided;

5 ‘‘(C) identification of adverse events, in6 cluding adverse events that result from errors;

7 ‘‘(D) performance of providers and sup8 pliers in meeting quality and safety standards

9 and performance measures;

10 ‘‘(E) corrective actions taken by providers

11 and suppliers when errors and other adverse

12 events are identified;

13 ‘‘(F) satisfaction of individuals receiving

14 care with the care provided; and

15 ‘‘(G) quality standards, performance meas16 ures, and best practices used by providers and

17 suppliers in achieving improvements in quality

18 and safety and achieving performance meas19 ures.

20 ‘‘(2) ESTABLISHMENT OF COMMON SETS OF

21 DATA ELEMENTS.—The Secretary shall establish

22 common sets of data elements and shall ensure com23 parability of data.

24 ‘‘(3) COORDINATION OF DATA.—The Secretary

25 shall coordinate the data systems described in sub-
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1 section (e)(1) to form a national database of infor2 mation reported to the quality improvement organi3 zations.

4 ‘‘(4) USE OF DATA.—The Secretary shall con5 duct analyses of such data—

6 ‘‘(A) to evaluate achievement in meeting

7 quality and safety standards and performance

8 standards among various types of providers and

9 suppliers;

10 ‘‘(B) to develop knowledge and under11 standing of medical errors and other adverse

12 events, to gain insight into better system design

13 to improve quality and safety, and to develop

14 quality and safety standards and performance

15 measures; and

16 ‘‘(C) to examine differences in quality of

17 care, safety, outcomes of care, and satisfaction

18 with care among different categories of individ19 uals entitled to benefits under this title by gen20 der, race, socioeconomic status, geography, and

21 type and severity of illness.

22 ‘‘(5) PUBLIC ACCESS TO DATA.—The Secretary

23 shall make such data available for public use in a

24 form that does not identify individuals, providers or

25 suppliers, or reporters of information.
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1 ‘‘(d) STANDARD PATIENT ASSESSMENT INSTRU2 MENTS.—

3 ‘‘(1) The Secretary shall establish and imple4 ment standard patient assessment instruments that

5 provide comparability of information.

6 ‘‘(2) CONSULTATION.—In establishing the

7 standard patient assessment instruments under this

8 subsection, the Secretary shall consult with rep9 resentatives of providers of services, suppliers, and

10 with appropriate organizations and entities rep11 resenting private sector entities to promote the de12 velopment and use of common sets of quality meas13 ures that represent the full spectrum of care ob14 tained by individuals entitled to benefits under this

15 title.

16 ‘‘(3) SOLE ASSESSMENT INSTRUMENTS.—The

17 standard patient assessment instruments established

18 under this subsection shall be the sole patient as19 sessment instrument utilized by the Secretary with

20 respect to items and services furnished under this

21 title, and shall supersede any patient assessment in22 strument or method utilized by the Secretary with

23 respect to such items and services.

24 ‘‘(4) ADJUSTMENT TO PAYMENT AMOUNTS FOR

25 SERVICES.—Notwithstanding any other provision of
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1 law, the Secretary shall use the standard patient as2 sessment instruments established under this sub3 section in determining payments amounts under this

4 title for items and services.

5 ‘‘(e) REQUIREMENTS FOR QUALITY IMPROVEMENT

6 ORGANIZATIONS.—The Secretary shall enter into agree7 ments with quality improvement organizations to carry out

8 the following functions:

9 ‘‘(1) IMPLEMENTATION OF DATA COLLECTION

10 SYSTEM.—To implement a standard data collection

11 system established by the Secretary to collect—

12 ‘‘(A) mandatory reports from providers

13 and suppliers on serious preventable adverse

14 events (as determined by the Secretary in regu15 lations);

16 ‘‘(B) voluntary reports of near misses (as

17 determined by the Secretary in regulations),

18 clinical systems problems, or other failures to

19 meet quality or safety standards or performance

20 standards;

21 ‘‘(C) reports of investigations of root

22 causes of serious preventable adverse events

23 and near misses;

24 ‘‘(D) corrective actions taken to address

25 identified quality and safety problems;
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1 ‘‘(E) data and information obtained in con2 ducting sampling of medical records and other

3 investigations of medical care;

4 ‘‘(F) data on performance of providers and

5 suppliers in achieving quality standards and

6 performance measures; and

7 ‘‘(G) such other information as the Sec8 retary determines appropriate.

9 ‘‘(2) REMOVAL FROM DATA OF PERSONALLY

10 IDENTIFIABLE INFORMATION.—To modify the data

11 received to remove identification of patients, pro12 viders or suppliers, and reporters of the information,

13 and to enter the information into a database.

14 ‘‘(3) INVESTIGATIONS OF ADVERSE EVENTS.—

15 To investigate serious preventable adverse events at

16 providers and suppliers as reported through the

17 mandatory reporting system.

18 ‘‘(4) ASSISTANCE WITH CORRECTIVE ACTION

19 PLANS.—To assist providers and suppliers to imple20 ment appropriate corrective action plans in response

21 to identification of serious preventable adverse

22 events.

23 ‘‘(5) DISSEMINATION OF INFORMATION TO PRO24 VIDERS.—To provide dissemination of information

25 and ongoing training to providers and suppliers re-
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1 garding quality and safety standards, performance

2 measures, best practices, analyses of information re3 garding quality or safety, and other quality and

4 safety improvement information.

5 ‘‘(6) FORUMS FOR DISCUSSIONS OF BEST PRAC6 TICES AND MEDICAL ERRORS.—To provide a means

7 of convening of providers and suppliers to discuss

8 medical errors, failures to achieve quality or safety

9 standards, performance measures, best practices,

10 lessons learned by other providers and suppliers, and

11 other quality and safety issues.

12 ‘‘(7) REVIEW OF MEDICAL RECORDS.—To con13 duct ongoing sampling and clinical data abstraction

14 of medical records of providers and suppliers and

15 data submitted by providers and suppliers on patient

16 assessment instruments to identify quality and safe17 ty problems and opportunities for improvement.

18 ‘‘(8) ANALYSIS OF DATA.—To conduct analyses

19 of the data included in the database to identify

20 issues indicating quality or safety problems, needed

21 systems changes, and opportunities for improvement.

22 ‘‘(9) FEEDBACK TO PROVIDERS.—To provide

23 ongoing feedback to providers, suppliers, and other

24 individuals regarding reports, lessons learned from

25 reports, investigations, and corrective actions.
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1 ‘‘(10) PROTECTING PERSONALLY IDENTIFIABLE

2 INFORMATION.—The provisions of section 1160 (re3 lating to prohibition against disclosure of informa4 tion) apply with respect to data or information on

5 adverse events reported to quality improvement or6 ganizations under this section, including such infor7 mation disseminated or discussed as provided for

8 under this subsection, in the same manner as such

9 provisions apply to information data or information

10 acquired by such an organization in the exercise of

11 its duties and functions under section 1160.

12 ‘‘(11) MAINTENANCE OF A TOLL-FREE TELE13 PHONE NUMBER.—To provide information via a toll14 free telephone number.

15 ‘‘(f) REQUIREMENTS FOR PROVIDERS AND SUP16 PLIERS.—Providers and suppliers furnishing items and

17 services under this title shall establish and maintain a

18 Medicare Quality and Safety Program, which shall include

19 the following elements:

20 ‘‘(1) CHIEF MEDICAL QUALITY AND SAFETY OF21 FICER.—Designation of a senior level Chief Medical

22 Quality and Safety Officer.

23 ‘‘(2) WRITTEN STANDARDS OF QUALITY

24 CARE.—Written standards for quality of care and

25 patient and employee safety, including error preven-
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1 tion, consistent with those promulgated by the Sec2 retary under subsection (b)(2), and policies and pro3 cedures for implementing those standards, including

4 disciplinary standards.

5 ‘‘(3) WRITTEN STANDARDS FOR PATIENTS

6 CARE.—Written standards for patient assessment,

7 preparation of a plan of care for each patient (in8 cluding participation of the patient in clinical deci9 sion making), coordination of services among all

10 those providing services for the patient, monitoring

11 of quality, safety, and patient improvement, and

12 records management.

13 ‘‘(4) ONGOING EDUCATION AND TRAINING.—

14 Ongoing conduct of effective education and training

15 of employees regarding quality and safety, including

16 the prevention of errors.

17 ‘‘(5) ONGOING MONITORING AND REPORTING.—

18 Ongoing monitoring and internal reporting of med19 ical quality and safety, including monitoring and re20 porting of serious preventable adverse events.

21 ‘‘(6) PROMPT DISCUSSION OF ADVERSE

22 EVENTS.—Prompt discussion with patients of ad23 verse events, including adverse events that result

24 from errors, and providing access to the patients of

25 information relating to such events.
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1 ‘‘(7) PROMPT REPORTING OF MEDICAL ER2 RORS.—Prompt reporting (as determined by the

3 Secretary) to the quality improvement organizations

4 of serious preventable adverse events, including ad5 verse events that result from errors, using standard

6 formats promulgated by the Secretary, and including

7 encouragement of reporting by employees.

8 ‘‘(8) COOPERATION IN CASE OF INVESTIGA9 TIONS.—Cooperation with the quality improvement

10 organizations in investigating causes of serious pre11 ventable adverse events, including adverse events

12 that result from errors, near misses, or other inves13 tigations of quality or safety.

14 ‘‘(9) COOPERATION IN DEVELOPMENT OF COR15 RECTIVE ACTION PLANS.—Cooperation with the

16 quality improvement organizations in developing cor17 rective action plans to address a serious preventable

18 adverse event, including an adverse event that re19 sults from an error, or a corrective action plan to

20 address other quality or safety problems.

21 ‘‘(10) COOPERATION IN PREPARING ANNUAL

22 REPORTS.—Cooperation with the quality improve23 ment organizations in preparing public annual re24 ports on progress in meeting quality and safety
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1 standards and performance measures, as determined

2 by the Secretary.

3 Notwithstanding any other provision of law, a provider or

4 supplier may report adverse events, including those result5 ing from errors, as provided under this section without

6 the consent of the individual who was furnished the med7 ical care which gave rise to the adverse event.

8 ‘‘(g) WHISTLEBLOWER PROTECTIONS.—A provider

9 of services or supplier may not penalize or take adverse

10 action against an employee because the employee reports

11 an adverse event to a quality improvement organization,

12 or submits data or information to the Secretary with re13 spect to the quality of items or services furnished under

14 this title by such provider or supplier, consistent with the

15 requirements of this section.

16 ‘‘(h) MEDICARE QUALITY AND SAFETY ADVISORY

17 COMMITTEE.—

18 ‘‘(1) ESTABLISHMENT.—The Secretary shall es19 tablish the Medicare Quality Advisory Committee

20 (hereinafter in this subsection referred to as the

21 ‘Committee’). The Secretary shall consult with the

22 Committee, and may consult directly with any panel

23 that the Committee establishes.
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1 ‘‘(2) DUTIES.—The Committee, and its panels,

2 shall provide advice and recommendations to the

3 Secretary with respect to—

4 ‘‘(A) the quality and safety of medical care

5 furnished to individuals entitled to benefits

6 under this title, including such individuals en7 rolled in Medicare+Choice plans under part C

8 of this title;

9 ‘‘(B) establishment of goals and specific

10 annual objectives with respect to such quality

11 and safety; and

12 ‘‘(C) other issues relating to such quality

13 and safety, including—

14 ‘‘(i) reporting and collection of data,

15 ‘‘(ii) appropriate research and anal16 ysis of data,

17 ‘‘(iii) quality and safety standards,

18 performance measures, and best practices,

19 ‘‘(iv) dissemination of information to

20 beneficiaries on treatment options,

21 ‘‘(v) dissemination of information on

22 quality of care and safety to providers and

23 suppliers, and

24 ‘‘(vi) such other quality of care and

25 safety issues as the Committee may con-
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1 sider appropriate, or of which as the Sec2 retary requests recommendations.

3 ‘‘(3) MEMBERSHIP; TERMS; COMPENSATION.—

4 ‘‘(A) MEMBERSHIP.—

5 ‘‘(i) NUMBER AND APPOINTMENT.—

6 The Commission shall be composed of 17

7 members, of whom 14 shall be appointed

8 in accordance with clause (ii) and 3 ap9 pointed in accordance with in clause (iii).

10 ‘‘(ii) PRIVATE INDIVIDUALS.—

11 ‘‘(I) IN GENERAL.—The Sec12 retary shall appoint 14 members from

13 among individuals who are qualified

14 by training and experience to evaluate

15 the matters referred to the Committee

16 and who are not officers or employees

17 of the United States.

18 ‘‘(II) PROVISIONS FOR CONFLICT

19 OF INTEREST.—Members shall recuse

20 themselves from participation in mat21 ters which present a potential per22 sonal conflict of interest or appear23 ance of such conflict that might intro24 duce bias in the process of making
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1 recommendations under this sub2 section.

3 ‘‘(iii) INDIVIDUALS REPRESENTING

4 ORGANIZATIONS.—The Secretary shall ap5 point one member from each of the fol6 lowing organizations:

7 ‘‘(I) The Medicare Coverage Ad8 visory Committee.

9 ‘‘(II) A quality improvement or10 ganization.

11 ‘‘(III) The National Advisory

12 Council for Healthcare Research and

13 Quality.

14 ‘‘(B) TERMS.—

15 ‘‘(i) IN GENERAL.—Members of the

16 Committee appointed under subparagraph

17 (A) shall serve for a term of 3 years.

18 ‘‘(ii) STAGGERED TERMS.—To ensure

19 the staggered rotation of one-third of the

20 members of the Committee each year, the

21 Secretary is authorized to appoint the ini22 tial members of the Committee for terms

23 of 1, 2, or 3 years.

24 ‘‘(iii) SERVICE BEYOND TERM.—A

25 member of the Committee appointed under
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1 subparagraph (A) may continue to serve

2 after the expiration of the term of the

3 members until a successor is appointed.

4 ‘‘(iv) VACANCIES.—If a member of

5 the Advisory Council appointed under sub6 paragraph (A) does not serve the full term

7 applicable under this subparagraph, the in8 dividual appointed to fill the resulting va9 cancy shall be appointed for the remainder

10 of the term of the predecessor of the indi11 vidual.

12 ‘‘(v) CHAIR.—The Secretary shall,

13 from among the members of the Com14 mittee appointed under subparagraph

15 (A)(ii), designate an individual to serve as

16 the chair of the Committee.

17 ‘‘(C) COMPENSATION.—

18 ‘‘(i) PRIVATE INDIVIDUALS.—Mem19 bers of the Committee appointed under

20 subparagraph (A)(ii) shall receive com21 pensation for each day (including travel

22 time) engaged in carrying out the duties of

23 the Advisory Council unless declined by the

24 member. Such compensation may not be in

25 an amount in excess of the daily equivalent
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1 of the annual rate of basic pay prescribed

2 for level IV of the Executive Schedule

3 under section 5315 of title 5, United

4 States Code, for each day during which

5 such member is engaged in the perform6 ance of the duties of the Advisory Council.

7 ‘‘(ii) INDIVIDUALS REPRESENTING OR8 GANIZATIONS.—Members appointed under

9 subparagraph (A)(iii) may not receive com10 pensation for service on the Committee in

11 addition to the compensation otherwise re12 ceived for duties carried out as members of

13 the organization.

14 ‘‘(4) REPORT.—

15 ‘‘(A) ANNUAL REPORT TO THE SEC16 RETARY.—Not later than May 1 of every year

17 beginning with 2002, the Committee shall sub18 mit to the Secretary a report on—

19 ‘‘(i) the activities of the Committee

20 during the preceding year;

21 ‘‘(ii) progress by providers of services

22 and suppliers in meeting goals and objec23 tives for improvement of the quality of

24 items and services furnished under this

25 title during such fiscal year; and
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1 ‘‘(iii) any recommendation of the

2 Committee with respect to quality of care

3 issues under this title.

4 ‘‘(B) PUBLICATION OF REPORT.—Not later

5 than 60 days after receipt of the report under

6 subparagraph (A), the Secretary shall publish

7 the report, together with any supplemental

8 views of the Secretary, on the Internet site of

9 the Department of Health and Human Services.

10 ‘‘(5) DURATION.—Section 14(a)(2)(B) of the

11 Federal Advisory Committee Act (5 U.S.C. App.; re12 lating to the termination of advisory committees)

13 shall not apply to the Committee.

14 ‘‘(i) REPORT TO CONGRESS.—The Secretary shall

15 submit to Congress an annual report on the progress of

16 providers and suppliers in meeting the goals and objectives

17 for improving quality of medical care and safety for indi18 viduals entitled to benefits under this title.

19 ‘‘(j) DEFINITIONS.—In this section:

20 ‘‘(1) ADVERSE EVENT.—The term ‘adverse

21 event’ means an unintended effect of medical inter22 vention that results in harm to a patient.

23 ‘‘(2) PREVENTABLE ADVERSE EVENT.—The

24 term ‘preventable adverse event’ means an adverse
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1 event that is preventable, including those that result

2 from errors.’’.

3 (2) EFFECTIVE DATE.—The amendment made

4 by paragraph (1) shall apply to items and services

5 furnished on or after—

6 (A) in the case of a hospital, rehabilitation

7 unit, or end stage renal disease provider, Octo8 ber 1, 2001; and

9 (B) in the case of any other provider or

10 supplier, at such time as the Secretary deter11 mines appropriate, but in no event earlier than

12 October 1, 2001.

13 (3) CONFORMING AMENDMENTS.—

14 (A) CONSULTATION WITH STATE AGEN15 CIES.—(i) Section 1864 of the Social Security

16 Act (42 U.S.C. 1395aa) is amended by adding

17 at the end the following new subsection:

18 ‘‘(f) In carrying out functions, relating to determina19 tion of conditions of participation by providers of services,

20 under subsections (e)(9), (f)(4), (j)(15), (o)(6), (cc)(2)(I),

21 and (dd)(2) of section 1861, or by ambulatory surgical

22 centers under section 1832(a)(2)(F)(i), the Secretary shall

23 consult with appropriate State agencies and recognized

24 national listing or accrediting bodies, and may consult

25 with appropriate local agencies. Such conditions pre-
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1 scribed under any of such subsections may be varied for

2 different areas or different classes of institutions or agen3 cies and may, at the request of a State, provide higher

4 requirements for such State than for other States; except

5 that, in the case of any State or political subdivision of

6 a State which imposes higher requirements on institutions

7 as a condition to the purchase of services (or of certain

8 specified services) in such institutions under a State plan

9 approved under title I, XVI, or XIX, the Secretary shall

10 impose like requirements as a condition to the payment

11 for services (or for the services specified by the State or

12 subdivision) in such institutions in such State or subdivi13 sion.’’.

14 (ii) The heading to such section is amended by

15 adding at the end the following:

16 ‘‘CONSULTATION WITH STATE AGENCIES AND OTHER OR17 GANIZATIONS TO DEVELOP CONDITIONS OF PARTICI18 PATION FOR PROVIDERS OF SERVICES’’.

19 (B) CHIEF MEDICARE QUALITY AND SAFE20 TY OFFICER.—Section 1117 of the Social Secu21 rity Act (42 U.S.C. 1317) is amended—

22 (i) in the heading, by striking ‘‘AND

23 CHIEF ACTUARY’’ and inserting ‘‘, CHIEF

24 ACTUARY, AND CHIEF MEDICARE QUALITY

25 AND SAFETY OFFICER’’; and
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1 (ii) by adding at the end the fol2 lowing:

3 ‘‘(c)(1) There is established in the Health Care Fi4 nancing Administration the position of Chief Medicare

5 Quality and Safety Officer. The Chief Medicare Quality

6 and Safety Officer shall be appointed by, and in direct

7 line of authority to, the Administrator of such Administra8 tion. The Chief Medicare Quality and Safety Officer shall

9 be appointed from among individuals who have dem10 onstrated, by their education and experience, superior ex11 pertise in the quality in the delivery of health care services.

12 The Chief Medicare Quality and Safety Officer shall exer13 cise such duties as are appropriate for the office of the

14 Chief Medicare Quality and Safety Officer. The Chief

15 Medicare Quality and Safety Officer may be removed only

16 for cause.

17 ‘‘(2) The Chief Medicare Quality and Safety Officer

18 shall be compensated at the highest rate of basic pay for

19 the Senior Executive Service under section 5382(b) of title

20 5, United States Code.’’.

21 (b) AGREEMENTS WITH PROVIDERS AND SUP22 PLIERS.—

23 (1) IN GENERAL.—Section 1866(a)(1) of the

24 Social Security Act (42 U.S.C. 1395cc(a)(1)) is

25 amended—
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1 (A) at the end of subparagraph (R) by

2 striking ‘‘and’’;

3 (B) at the end of subparagraph (S) by

4 striking the period and inserting ‘‘, and’’; and

5 (C) by inserting after subparagraph (S)

6 the following new subparagraph:

7 ‘‘(T) to carry out requirements with respect to

8 comprehensive quality of medical care and safety for

9 items and services furnished to individuals entitled

10 to benefits under this title imposed under section

11 1863, in such manner and within such timeframes

12 as the Secretary establishes in regulations, including

13 prompt reporting of medical errors to the Secretary

14 or to quality improvement organizations.’’.

15 (2) EFFECTIVE DATE.—The amendments made

16 by paragraph (1) shall apply to items and services

17 furnished on or after—

18 (A) in the case of a hospital, rehabilitation

19 unit, or end stage renal disease provider, Octo20 ber 1, 2001; and

21 (B) in the case of any other provider or

22 supplier, at such time as the Secretary deter23 mines appropriate, but in no event earlier than

24 October 1, 2001.
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1 (c) REDESIGNATION OF PEER REVIEW ORGANIZA2 TION AS QUALITY IMPROVEMENT ORGANIZATION.—

3 (1) UTILIZATION AND QUALITY CONTROL PEER

4 REVIEW ORGANIZATION.—

5 (A) IN GENERAL.—The following sections

6 of the Social Security Act are each amended by

7 striking ‘‘utilization and quality control peer re8 view organization’’ each place it appears and in9 serting ‘‘quality improvement organization’’:

10 (i) TITLE XI.—1128A(h), 1151,

11 1153(b)(1), the second sentence of

12 1153(c), 1153(d)(3), 1153(d)(4), 1154(a),

13 1154(c), 1154(d), 1156(c), 1158(a), and

14 1161(a)(1) (42 U.S.C. 1320a–7a(h),

15 1320c, 1320c–2(b)(1), 1320c–2(c), 1320c–

16 2(d)(3), 1320c–2(d)(4), 1320c–3(a),

17 1320c–3(c), 1320c–3(d), 1320c–5(c),

18 1320c–7(a), 1320c–10(a)(1), respectively).

19 (ii) TITLE XVIII.—1862(a)(15)(A),

20 1862(g), 1866(a)(1)(F)(i),

21 1866(a)(1)(F)(ii), 1867(d)(3),

22 1876(i)(7)(A), 1879(a), and 1886(f)(2)

23 (42 U.S.C. 1395y(a)(15)(A), 1395y(g),

24 1395cc(a)(1)(F)(i), 1395cc(a)(1)(F)(ii),

25 1395dd(d)(3), 1395mm(i)(7)(A),
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1 1395pp(a), and 1395ww(f)(2) respec2 tively).

3 (iii) TITLE XIX.—1902(d),

4 1903(a)(3)(C)(i), and section 1921(b)(4)

5 (42 U.S.C. 1396a(d), 1396b(a)(3)(C)(i),

6 and 1396r–2(b)(4), respectively).

7 (B) HEADINGS.—The headings of the fol8 lowing sections of title XI of the Social Security

9 Act are each amended by striking ‘‘UTILIZA10 TION AND QUALITY CONTROL PEER REVIEW OR11 GANIZATION’’ each place it appears and insert12 ing ‘‘QUALITY IMPROVEMENT ORGANIZATION’’:

13 1152, 1153, and 1163 (42 U.S.C. 1320c–1,

14 1320c–2, and 1320c–12, respectively).

15 (2) PEER REVIEW ORGANIZATION.—The fol16 lowing sections of the Social Security Act are each

17 amended by striking ‘‘peer review organization’’ each

18 place it appears and inserting ‘‘quality improvement

19 organization’’:

20 (A) TITLE XI.—1153(e)(2), 1153(h)(3),

21 1154(a)(2)(B), 1154(a)(3)(E)(i),

22 1154(a)(4)(A), 1154(a)(4)(C), 1154(e)(2),

23 1154(e)(3)(A)(ii), 1154(e)(3)(B),

24 1154(e)(4)(B), 1155, 1156(a)(3), and

25 1160(b)(1) (42 U.S.C. 1320c–2(e)(2), 1320c–
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1 2(h)(3), 1320c–3(a)(2)(B), 1320c–

2 3(a)(3)(E)(i), 1320c–3(a)(4)(A), 1320c–

3 3(a)(4)(C), 1320c–3(e)(2), 1320c–

4 3(e)(3)(A)(ii), 1320c–3(e)(3)(B), 1320c–

5 3(e)(4)(B), 1320c–4, 1320c–5(a)(3), and

6 1320c–9(b)(1), respectively).

7 (B) TITLE XVIII.—1820(c)(2)(B)(iii),

8 1820(d)(2)(C)(ii), 1842(l)(1)(A)(iii)(I),

9 1842(l)(2), and 1866(a)(3) (42 U.S.C. 1395i–

10 4(c)(2)(B)(iii), 1395i–4(d)(2)(C)(ii),

11 1395u(l)(1)(A)(iii)(I), 1395u(l)(2), and

12 1395cc(a)(3), respectively).

13 (C) TITLE XIX.—1921(a)(1) (42 U.S.C.

14 1396r–2(a)(1)).

15 (3) PEER REVIEW ORGANIZATIONS.—

16 (A) IN GENERAL.—Sections 1151,

17 1153(g), 1154(a)(10)(B), and 1154(f) of the

18 Social Security Act (42 U.S.C. 1320c, 1320c–

19 2(g), and 1320c–3(a)(10)(B), respectively) are

20 each amended by striking ‘‘peer review organi21 zations’’ each place it appears and inserting

22 ‘‘quality improvement organizations’’.

23 (B) HEADINGS.—The headings of sections

24 1154 and 1867(d)(3) of the Social Security Act

25 (42 U.S.C. 1320c–3 and 1395dd, respectively)
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1 are each amended by striking ‘‘PEER REVIEW

2 ORGANIZATIONS’’ and inserting ‘‘QUALITY IM3 PROVEMENT ORGANIZATIONS’’.

4 (4) QUALITY CONTROL AND PEER REVIEW OR5 GANIZATION.—The following sections of title XVIII

6 of the Social Security Act are each amended by

7 striking ‘‘quality control and peer review organiza8 tion’’ each place it appears and inserting ‘‘quality

9 improvement organization’’: 1815(b),

10 1832(a)(2)(F)(ii)(I), 1861(v)(1)(G)(i), 1861(w)(2),

11 and 1879(e) (42 U.S.C. 1395g(b),

12 1395k(a)(2)(F)(ii)(I), 1395x(v)(1)(G)(i),

13 1395x(w)(2), and 1395pp, respectively).

14 (5) REFERENCES.—Any reference in a law, reg15 ulation, document, paper, or other record of the

16 United States to a ‘‘peer review organization’’, ‘‘uti17 lization and quality control peer review organiza18 tion’’, or ‘‘quality control and peer review organiza19 tion’’ under part B of title XI of the Social Security

20 Act shall be deemed to be a reference to a ‘‘quality

21 improvement organization’’ under such part.

22 (d) ADDITIONAL PROVISIONS REGARDING QUALITY

23 IMPROVEMENT ORGANIZATIONS.—

24 (1) EXPANSION OF QUALITY REVIEW AUTHOR25 ITY TO ALL PROVIDERS AND SUPPLIERS.—
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1 (A) IN GENERAL.—Section 1154 of the So2 cial Security Act (42 U.S.C. 1320c–3) is

3 amended by adding at the end the following

4 new subsection:

5 ‘‘(g) In this section, the terms ‘providers of health

6 care services’ and ‘provider’ includes suppliers of items

7 under title XVIII and Medicare+Choice organizations of8 fering Medicare+Choice plans under part C of such title.

9 (B) EXPANSION OF CATEGORY OF SERV10 ICES FOR WHICH REVIEW MAY BE RE11 QUESTED.—Section 1154(e) of the Social Secu12 rity Act (42 U.S.C. 1320c–3(e)) is amended—

13 (i) in paragraph (1)(A)—

14 (I) by striking ‘‘hospital’’ and in15 serting ‘‘provider’’; and

16 (II) by striking ‘‘inpatient hos17 pital care’’ and inserting ‘‘items or

18 services furnished’’;

19 (ii) in paragraph (1)(B) by striking

20 ‘‘hospital’s’’ and inserting ‘‘provider’s’’;

21 (iii) in the matter following subpara22 graph (B) of paragraph (1), by striking

23 ‘‘hospital’’ and inserting ‘‘provider’’;

24 (iv) in paragraph (2)(A)—
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1 (I) by striking ‘‘hospital’’ and in2 serting ‘‘provider’’; and

3 (II) by striking ‘‘inpatient hos4 pital care’’ and inserting ‘‘items or

5 services furnished’’;

6 (v) in paragraph (2)(B) by striking

7 ‘‘hospital’s’’ and inserting ‘‘provider’s’’;

8 (vi) in the matter following subpara9 graph (B) of paragraph (2)—

10 (I) by striking ‘‘hospital’’ each

11 place it appears and inserting ‘‘pro12 vider’’; and

13 (II) by striking ‘‘hospital’s’’ and

14 inserting ‘‘provider’s’’;

15 (vii) in paragraph (3)(A), in the mat16 ter following clause (ii) of such

17 paragraph—

18 (I) by striking ‘‘hospital’s’’ and

19 inserting ‘‘provider’s’’;

20 (II) by striking ‘‘the hospital’’

21 each place it appears and inserting

22 ‘‘the provider’’; and

23 (III) by striking ‘‘continued hos24 pital care’’ and inserting ‘‘continued

25 care’’;
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1 (viii) in paragraph (3)(B)—

2 (I) in the matter preceding clause

3 (i), by striking ‘‘an inpatient in the

4 hospital’’ and inserting ‘‘a patient

5 being furnished items or services by

6 the provider’’; and

7 (II) in clause (i), by striking

8 ‘‘hospital’’ and inserting ‘‘provider’’;

9 and

10 (ix) in paragraph (4)—

11 (I) by striking ‘‘the hospital’’ and

12 inserting ‘‘the provider’’; and

13 (II) by striking ‘‘inpatient hos14 pital services’’ and inserting ‘‘items or

15 services’’.

16 (C) CONDITION OF PARTICIPATION FOR

17 ALL PROVIDERS, SUPPLIERS, AND

18 MEDICARE+CHOICE ORGANIZATIONS.—Section

19 1886(a) of the Social Security Act (42 U.S.C.

20 1395ww(a)) is amended—

21 (i) in paragraph (1)(F)(ii), by striking

22 ‘‘and home health agencies,’’ and ‘‘or agen23 cy’’ and inserting ‘‘home health agencies,

24 other provider of services, suppliers, and

25 Medicare+Choice organizations offering
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1 Medicare+Choice plans under part ’’ and

2 ‘‘agency, other provider of services, sup3 plier, or Medicare+Choice organization’’,

4 respectively; and

5 (ii) in paragraph (3), by striking ‘‘or

6 agency’’ each place it appears and insert7 ing ‘‘agency, other provider of services,

8 supplier, or Medicare+Choice organiza9 tion’’.

10 (D) CONDUCT OF PROVIDER AND SUP11 PLIER PROFILING.—Section 1154(a) of the So12 cial Security Act (42 U.S.C. 1320c–3(a)) is

13 amended by adding at the end the following

14 new paragraph:

15 ‘‘(17) The organization shall monitor and pro16 file billing patterns of providers of services within

17 each area or locality and provide comparative data

18 to providers of services whose utilization patterns

19 vary significantly from other providers of services in

20 the same payment area or locality.’’.

21 (2) PROHIBITION ON CONDUCT OF FRAUD AND

22 ABUSE INVESTIGATIONS.—Section 1154(a) of the

23 Social Security Act (42 U.S.C. 1320c–3(a)) is

24 amended by inserting after paragraph (11) the fol25 lowing new paragraph:
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1 ‘‘(12) The organization shall not conduct activi2 ties that the Secretary, acting through the Office of

3 the Inspector General of the Department of Health

4 and Human Services, and the Attorney General con5 duct under sections 1128C, 1128D, or 1128E with

6 respective to the program to control fraud and abuse

7 established and carried out under those sections and

8 under the Medicare Integrity Program under section

9 1893.’’.

10 (3) AUTHORIZING THE SECRETARY TO APPROVE

11 CONTRACT OBJECTIVES.—(A) Section 1153(c)(7) of

12 the Social Security Act (42 U.S.C. 1320c–2(c)(7)) is

13 amended—

14 (i) by striking ‘‘shall’’ and inserting

15 ‘‘may’’; and

16 (ii) by striking ‘‘negotiated’’ each place it

17 appears.

18 (B) Section 1154(a)(4)(A) of such Act (42

19 U.S.C. 1320c–3(a)(4)(A)) is amended by striking

20 ‘‘after consultation with the Secretary’’ and insert21 ing ‘‘upon approval of the Secretary’’.

22 (4) CLARIFYING THE AUTHORITY OF THE SEC23 RETARY TO REQUIRE ORGANIZATIONS TO CONSIDER

24 CERTAIN CRITERIA AND CASES.—Section

25 1154(a)(4)(A) of the Social Security Act (42 U.S.C.
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1 1320c–3(a)(4)(A)), as amended by paragraph

2 (3)(B), is further amended by inserting after the

3 first sentence the following: ‘‘IN carrying out the

4 previous sentence, the organization shall consider

5 types and kinds of cases and shall apply such guide6 lines as the Secretary determines appropriate, in7 cluding national, professionally-developed standards

8 of care.’’.

9 (5) ELIMINATION OF REQUIREMENT FOR MAN10 DATORY PRIOR APPROVAL FOR USE OF ASSISTANT

11 AT CATARACT SURGERY.—Section 1862(a)(15) of

12 the Social Security Act (42 U.S.C. 1395y(a)(15)) is

13 amended by striking ‘‘(A) which are for’’ and all

14 that follows through ‘‘(B) which are for’’ and insert15 ing ‘‘which are for’’.

16 (6) ELIMINATION OF ON SITE REVIEW RE17 QUIREMENT.—Section 1154(a) of the Social Security

18 Act (42 U.S.C. 1320c–3(a)) is amended by striking

19 paragraph (15).

20 (7) CLARIFYING THE AUTHORITY OF THE SEC21 RETARY TO DECLINE TO RENEW A CONTRACT WITH

22 AN ORGANIZATION FOR REASONS OTHER THAN POOR

23 PERFORMANCE.—Section 1153(c)(4) of the Social

24 Security Act (42 U.S.C. 1320c–2(c)(4)) is amended

25 by inserting ‘‘on the basis of the organization’s per-
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1 formance or of any other criteria the Secretary de2 termines appropriate’’ after ‘‘if the Secretary intends

3 not to renew a contract’’.

4 (8) ELIMINATION OF DUPLICATIVE REPORTING

5 REQUIREMENT.—Title XI of the Social Security Act

6 (42 U.S.C. 1301 et seq.) is amended by striking sec7 tion 1161.

8 (9) EFFECTIVE DATE.—The amendments made

9 by this subsection take effect the date of the enact10 ment of this Act and apply to contracts entered into

11 or renewed on or after that date.

Æ