II

103D CONGRESS

1ST SESSION S. 1494

To amend the Social Security Act to improve the exchange of information

relating to health care services, to provide for measurement of health

care quality, and for other purposes.

IN THE SENATE OF THE UNITED STATES

SEPTEMBER 24 (legislative day, SEPTEMBER 7), 1993

Mr. BOND (for himself, Mr. RIEGLE, and Mr. BURNS) introduced the following bill; which was read twice and referred to the Committee on Labor

and Human Resources

A BILL

To amend the Social Security Act to improve the exchange

of information relating to health care services, to provide

for measurement of health care quality, 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 ‘‘Health Care Informa5 tion Modernization and Security Act of 1993’’.
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1 SEC. 2. ESTABLISHMENT OF HEALTH CARE DATA INTER2 CHANGE SYSTEM.

3 (a) IN GENERAL.—The Social Security Act (42

4 U.S.C. 301 et seq.) is amended by adding at the end the

5 following new title:

6 ‘‘TITLE XXI—HEALTH CARE DATA

7 INTERCHANGE SYSTEM

8 ‘‘HEALTH CARE DATA PANEL

9 ‘‘SEC. 2101. (a) ESTABLISHMENT.—There is estab10 lished a panel to be known as the Health Care Data Panel

11 (referred to in this section as the ‘Panel’).

12 ‘‘(b) MEMBERSHIP.—

13 ‘‘(1) IN GENERAL.—The Panel shall be com14 posed of the following members:

15 ‘‘(A) The Secretary (or his or her des16 ignee).

17 ‘‘(B) The Secretary of Defense (or his or

18 her designee).

19 ‘‘(C) The Secretary of Veterans Affairs (or

20 his or her designee).

21 ‘‘(D) A representative of the Agency for

22 Health Care Policy and Research.

23 ‘‘(E) A representative of the National In24 stitute of Standards and Technology.
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1 ‘‘(F) A representative of the National Tele2 communication and Information Administra3 tion.

4 ‘‘(G) Six additional Federal officers deter5 mined appropriate by the Secretary.

6 ‘‘(2) CHAIRPERSON.—The Secretary shall be

7 the Chairperson of the Panel.

8 ‘‘(c) MEETINGS.—

9 ‘‘(1) IN GENERAL.—Except as provided in para10 graph (2), the Panel shall meet at the call of the

11 Chairperson.

12 ‘‘(2) INITIAL AND SUBSEQUENT MEETINGS.—

13 The Panel shall hold a meeting not later than 30

14 days after the date of the enactment of this section

15 and at least annually thereafter.

16 ‘‘(3) QUORUM.—A majority of the members of

17 the Panel shall constitute a quorum, but a lesser

18 number of members may hold hearings.

19 ‘‘(d) POWERS OF THE PANEL.—

20 ‘‘(1) HEARINGS.—The Panel may hold such

21 hearings, sit and act at such times and places, take

22 such testimony, and receive such evidence as the

23 Panel considers advisable to carry out the purposes

24 of this section.
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1 ‘‘(2) INFORMATION FROM FEDERAL AGEN2 CIES.—The Panel may secure directly from any Fed3 eral department or agency such information as the

4 Panel considers necessary to carry out the provisions

5 of this section. Upon request of the Chairperson of

6 the Panel, the head of such department or agency

7 shall furnish such information to the Panel.

8 ‘‘(3) POSTAL SERVICES.—The Panel may use

9 the United States mails in the same manner and

10 under the same conditions as other departments and

11 agencies of the Federal Government.

12 ‘‘(4) GIFTS.—The Panel may accept, use, and

13 dispose of gifts or donations of services or property.

14 ‘‘(e) PANEL PERSONNEL MATTERS.—

15 ‘‘(1) COMPENSATION OF MEMBERS.—Members

16 of the Panel shall serve without compensation in ad17 dition to that received for their services as officers

18 or employees of the Federal Government.

19 ‘‘(2) STAFF.—

20 ‘‘(A) DETAIL OF GOVERNMENT EMPLOY21 EES.—Upon the request of the Chairperson any

22 Federal Government employee may be detailed

23 to the Panel without reimbursement, and such

24 detail shall be without interruption or loss of

25 civil service status or privilege.
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1 ‘‘(B) CONTRACTS.—The Chairperson may

2 enter into contracts or other arrangements that

3 may be necessary for the Panel to perform its

4 duties.

5 ‘‘(C) INTERNAL ORGANIZATION.—The

6 Chairperson may prescribe such rules as the

7 Chairperson determines necessary with respect

8 to the internal organization of the Panel.

9 ‘‘(f) DUTIES OF THE PANEL.—

10 ‘‘(1) IN GENERAL.—The Panel shall, in con11 sultation with the Health Informatics Commission

12 established under section 2102, develop proposed

13 regulations for the implementation and ongoing op14 eration of an integrated electronic health care data

15 interchange system which are based on the operating

16 requirements for the system established, selected, or

17 developed by the Panel under paragraphs (1)

18 through (7) of subsection (i). Such proposed regula19 tions shall ensure—

20 ‘‘(A) the integration of all participants in

21 the health care system (as defined in subsection

22 (l)(1));

23 ‘‘(B) the use of uniform processes which

24 will permit participants in the health care sys-
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1 tem to communicate electronically for the sub2 mission and receipt of health care data;

3 ‘‘(C) the privacy of individuals who are pa4 tients receiving health care services and the

5 confidentiality of information in the data inter6 change system;

7 ‘‘(D) that the data in the system is verifi8 able, timely, accurate, reliable, useful, complete,

9 relevant, time and date stamped, and com10 parable; and

11 ‘‘(E) an overall reduction in the adminis12 trative burdens and costs of the health care sys13 tem, an overall increase in the productivity, ef14 fectiveness, and efficiency of the system, and an

15 overall increase in the quality of care furnished

16 by the system.

17 ‘‘(2) TIMING FOR DEVELOPMENT AND SUBMIS18 SION OF PROPOSED REGULATIONS.—Not later than

19 30 days after the date on which the Panel is re20 quired to establish, select, or develop any of the op21 erating requirements for the system as set forth in

22 paragraphs (1) through (7) of subsection (i), the

23 Panel shall submit to the Office of Management and

24 Budget (referred to in this section as the ‘OMB’)

25 the proposed regulations developed by the Panel
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1 under paragraph (1) which relate to such operating

2 requirements.

3 ‘‘(g) IMPLEMENTATION OF THE REGULATORY PRO4 POSALS DEVELOPED BY THE PANEL.—

5 ‘‘(1) PROMULGATION OF REGULATIONS.—

6 ‘‘(A) IN GENERAL.—OMB shall promul7 gate regulations based on the proposed regula8 tions submitted under paragraph (1) within 90

9 days after the date such proposed regulations

10 are submitted.

11 ‘‘(B) REGULATIONS NOT BASED ON

12 ‘‘(2) APPLICABILITY.—

13 ‘‘(A) IN GENERAL.—The regulations pro14 mulgated by OMB shall apply to any health

15 care program administered by the Department

16 of Health and Human Services, the Department

17 of Defense, and the Department of Veterans

18 Affairs and any participants in the health care

19 system affected by such programs.

20 ‘‘(B) SPECIAL RULE REGARDING THE MED21 ICARE PROGRAM.—The Secretary may incor22 porate the capabilities of the common working

23 file used in the medicare program under title

24 XVIII into a uniform working file system devel-
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1 oped and operated according to regulations pro2 mulgated under subparagraph (A).

3 ‘‘(3) COMPLIANCE WITH REGULATIONS.—

4 ‘‘(A) IN GENERAL.—Except as provided in

5 subparagraph (B), not later than 1 year after

6 the date on which any regulations are promul7 gated by OMB, the persons described in para8 graph (2)(A) shall be required to comply with

9 such regulations.

10 ‘‘(B) COMPREHENSIVE QUALITY MEASURE11 MENT DATA.—Not later than 2 years after the

12 date on which any regulations are promulgated

13 by OMB relating to standards, conventions, and

14 requirements for comprehensive quality meas15 urement data (as described in subsection

16 (i)(1)(E)(iv)), the persons described in para17 graph (2)(A) shall be required to comply with

18 such regulations.

19 ‘‘(h) MODIFICATIONS.—The Panel shall continuously

20 monitor the implementation of the regulations promul21 gated by OMB under paragraph (1) of subsection (g) and

22 shall submit to OMB any proposed modifications to such

23 regulations determined appropriate by the Panel. The re24 quirements of subsection (g) shall apply to any such pro25 posed modifications in the same manner as such require-
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1 ments apply to the proposed regulations initially submit2 ted by the Panel.

3 ‘‘(i) OPERATING STANDARDS, CONVENTIONS, RE4 QUIREMENTS, AND PROCEDURES FOR THE DATA INTER5 CHANGE SYSTEM.—

6 ‘‘(1) SELECTION AND ESTABLISHMENT OF

7 DATA AND TRANSACTION STANDARDS, CONVEN8 TIONS, AND REQUIREMENTS FOR THE DATA INTER9 CHANGE SYSTEM.—

10 ‘‘(A) IN GENERAL.—The Panel, in con11 sultation with the American National Standards

12 Institute (referred to in this section as ‘ANSI’),

13 shall select and establish data and transaction

14 standards, conventions, and requirements that

15 permit the electronic interchange of any health

16 care data the Panel determines necessary for

17 the efficient and effective administration of the

18 health care system.

19 ‘‘(B) MINIMUM REQUIREMENTS.—The

20 data and transaction standards, conventions,

21 and requirements selected and established by

22 the Panel under this paragraph shall, at a mini23 mum—

24 ‘‘(i) ensure that the data interchange

25 system shall have the capability to comply
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1 with such standards, conventions, and re2 quirements; and

3 ‘‘(ii) be based on any standards that

4 are in use and generally accepted on the

5 date of the enactment of this Act or that

6 are recommended by nationally recognized

7 standard setting groups, including ANSI,

8 the National Uniform Billing Committee,

9 the Uniform Claim Form Task Force, the

10 National Committee for Prescription Drug

11 Programs, and the Healthcare Informatics

12 Standards Planning Panel.

13 ‘‘(C) APPLICABILITY.—The proposed regu14 lations developed by the Panel shall provide

15 that—

16 ‘‘(i) any participant in the health care

17 system who has the capability to inter18 change data through a uniform working

19 file developed by the Panel under para20 graph (2) shall be required to transmit and

21 receive such data using the standards, con22 ventions, and requirements developed by

23 the Panel under this paragraph; and

24 ‘‘(ii) any participant in the health

25 care system who does not have such capa-
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1 bility shall be required to transmit and re2 ceive data through a health care informa3 tion clearinghouse or a health care value

4 added network that is certified under the

5 procedure established pursuant to sub6 section (k).

7 ‘‘(D) ADDITIONAL REQUIREMENTS.—

8 ‘‘(i) IN GENERAL.—The proposed reg9 ulations developed by the Panel shall pro10 vide that no participant in the health care

11 system shall be permitted to establish data

12 requirements in addition to such stand13 ards, conventions, and requirements estab14 lished by the Panel and included in regula15 tions promulgated by OMB—

16 ‘‘(I) unless two or more partici17 pants voluntarily establish such addi18 tional requirements and the require19 ments meet all of the privacy and con20 fidentiality standards developed by the

21 Panel under this section and included

22 in any regulations promulgated by

23 OMB under subsection (g); or
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1 ‘‘(II) a waiver is granted under

2 clause (ii) to establish such additional

3 requirements.

4 ‘‘(ii) CONDITIONS FOR WAIVERS.—

5 ‘‘(I) IN GENERAL.—The proposed

6 regulations developed by the Panel

7 shall provide that any participant in

8 the health care system may request a

9 waiver to establish additional data re10 quirements.

11 ‘‘(II) CONSIDERATION OF WAIV12 ER REQUESTS.—The proposed regula13 tions developed by the Panel shall pro14 vide that no waiver shall be granted

15 under this clause unless the entity

16 granting such waiver considers the

17 value of the additional data to be ex18 changed for research or other pur19 poses determined appropriate by the

20 Panel, the administrative cost of the

21 additional data requirements, the bur22 den of the additional data require23 ments, and the burden of the timing

24 of the imposition the additional data

25 requirements.
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1 ‘‘(III) CERTAIN REQUESTS FOR

2 WAIVERS.—The proposed regulations

3 developed by the Panel shall provide

4 that if a participant in the health care

5 system attempts to impose additional

6 data requirements on any other such

7 participant, the participant on which

8 such requirements are being imposed

9 may contact the Secretary. The Panel

10 shall develop a procedure under which

11 any participant in the health care sys12 tem contacting the Secretary under

13 the preceding sentence shall remain

14 anonymous. The Secretary shall notify

15 the participant imposing the addi16 tional data requirements that such re17 quirements may not be imposed on

18 any other participant unless such

19 other participant voluntarily agrees to

20 such requirements or a waiver is ob21 tained under this clause.

22 ‘‘(E) TIMETABLE FOR STANDARDS, CON23 VENTIONS, AND REQUIREMENTS.—

24 ‘‘(i) INITIAL STANDARDS, CONVEN25 TIONS, AND REQUIREMENTS RELATING TO
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1 FINANCIAL AND ADMINISTRATIVE TRANS2 ACTIONS.—Not later than 9 months after

3 the date of the enactment of this section,

4 the Panel shall develop data and trans5 action standards, conventions, and require6 ments for the following items relating to

7 the financing and administration of health

8 care:

9 ‘‘(I) Enrollment.

10 ‘‘(II) Eligibility.

11 ‘‘(III) Payment and remittance

12 advice.

13 ‘‘(IV) Claims.

14 ‘‘(V) Claims status.

15 ‘‘(VI) Coordination of benefits.

16 ‘‘(VII) Crossover billing.

17 ‘‘(VIII) First report of injury.

18 ‘‘(IX) Standardized claim attach19 ments.

20 ‘‘(ii) OTHER STANDARDS, CONVEN21 TIONS, AND REQUIREMENTS RELATING TO

22 FINANCIAL AND ADMINISTRATIVE TRANS23 ACTIONS.—Not later than 9 months after

24 the date of the enactment of this section,

25 the Panel shall develop data and trans-
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1 action standards, conventions, and require2 ments for items relating to the financing

3 and administration of health care delivery

4 that are not described in clause (i).

5 ‘‘(iii) STANDARDS, CONVENTIONS,

6 AND REQUIREMENTS RELATING TO INITIAL

7 QUALITY MEASUREMENT INDICATORS.—

8 Not later than 12 months after the date of

9 the enactment of this section, the Panel

10 shall develop data and transaction stand11 ards, conventions, and requirements for

12 participants in the health care system to

13 transmit data derived from the financial

14 and administrative transactions data de15 scribed in clause (i) on quality measure16 ment, utilization monitoring, risk assess17 ment, patient satisfaction, outcomes, and

18 access.

19 ‘‘(iv) STANDARDS, CONVENTIONS, AND

20 REQUIREMENTS RELATING TO COM21 PREHENSIVE QUALITY MEASUREMENT

22 DATA.—Not later than 24 months after

23 the date of the enactment of this section,

24 the Panel shall develop standards, conven25 tions, and requirements for participants in
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1 the health care system to transmit com2 prehensive data collected at the site of care

3 on quality measurement, utilization mon4 itoring, risk assessment, patient satisfac5 tion, outcomes, and access.

6 ‘‘(v) STANDARDS, CONVENTIONS, AND

7 REQUIREMENTS RELATING TO DATA ON

8 PATIENT CARE RECORDS.—Not later than

9 36 months after the date of the enactment

10 of this section, the Panel shall develop

11 standards, conventions, and requirements

12 related to the inclusion of data from pa13 tient care records into the health care data

14 interchange system, including standards,

15 conventions, and requirements on the iden16 tification of the origin of any data from

17 such records that is included in such sys18 tem.

19 ‘‘(F) DATA AND TRANSACTION STAND20 ARDS, CONVENTIONS, AND REQUIREMENTS FOR

21 THE CENTERS FOR DISEASE CONTROL AND

22 PREVENTION.—Not later than 36 months after

23 the date of the enactment of this section, the

24 Panel, in collaboration with the Centers for

25 Disease Control and Prevention (referred to in
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1 this section as the ‘CDCP’) and in consultation

2 with State departments of health, shall develop

3 data and transaction standards, conventions,

4 and requirements for the electronic interchange

5 of data on vital health statistics collected by

6 CDCP or the States or any other such data as

7 CDCP determines appropriate.

8 ‘‘(G) WAIVERS OF COMPLIANCE.—

9 ‘‘(i) FINANCIAL AND ADMINISTRATIVE

10 TRANSACTIONS.—The proposed regulations

11 developed by the Panel shall provide that

12 any of the data and transaction standards,

13 conventions, and requirements relating to

14 financial and administrative transactions

15 developed by the Panel under subpara16 graph (E)(i) may be waived until January

17 1, 1995 for a health care provider that—

18 ‘‘(I) does not have access to a

19 health care information clearinghouse

20 or a health care value added network,

21 is in the process of developing a sys22 tem that complies with such stand23 ards, conventions, and requirements,

24 and executes an agreement with the

25 appropriate regulatory entity that
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1 such provider will meet such stand2 ards, conventions, and requirements

3 by a specified date (not later than

4 January 1, 1995); or

5 ‘‘(II) is a small rural hospital (as

6 defined by the Panel and included in

7 regulations promulgated by OMB

8 under subsection (g)).

9 ‘‘(ii) ADVANCED QUALITY MEASURE10 MENT DATA.—The proposed regulations

11 developed by the Panel shall provide that

12 any of the data and transaction standards,

13 conventions, and requirements relating to

14 advanced quality measurement data devel15 oped by the Panel under subparagraph

16 (E)(iv) may be waived until January 1,

17 1998 for a health care provider that—

18 ‘‘(I) does not have access to a

19 health care information clearinghouse

20 or a health care value added network,

21 is in the process of developing a sys22 tem that complies with such stand23 ards, conventions, and requirements,

24 and executes an agreement with the

25 appropriate regulatory entity that
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1 such provider will meet such stand2 ards and requirements by a specified

3 date (not later than January 1,

4 1998); or

5 ‘‘(II) agrees to obtain from such

6 provider’s records the data elements

7 that are needed to meet the standards

8 and requirements developed under

9 subparagraph (E)(iv) and agrees to

10 subject the provider’s data transfer

11 process to a quality assurance pro12 gram that is satisfactory to the appro13 priate regulatory entity.

14 ‘‘(2) STANDARDS FOR OPERATION OF A UNI15 FORM WORKING FILE.—

16 ‘‘(A) IN GENERAL.—Not later than 24

17 months after the date of the enactment of this

18 section the Panel shall establish standards for

19 the development and operation of a uniform

20 working file system that is national in scope.

21 Such standards shall ensure—

22 ‘‘(i) that all participants in the health

23 care system may be linked electronically

24 (directly or indirectly) to the uniform

25 working file system;
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1 ‘‘(ii) that any privacy and confiden2 tiality standards established by the Panel

3 under paragraph (5) are satisfied;

4 ‘‘(iii) that the uniform working file

5 system improves the efficiency and effec6 tiveness of the administration of the health

7 care system, including health care quality

8 measurement;

9 ‘‘(iv) the interoperability of the uni10 form working file system by—

11 ‘‘(I) supporting the data and

12 transaction standards, conventions,

13 and requirements selected and estab14 lished by the Panel; and

15 ‘‘(II) making use of such stand16 ards, conventions, and requirements;

17 and

18 ‘‘(v) the support of any other require19 ments selected or established by the Panel.

20 ‘‘(3) CODE SETS FOR SYSTEM.—

21 ‘‘(A) IN GENERAL.—Not later than 9

22 months after the date of the enactment of this

23 section the Panel shall select and establish code

24 sets that are maintained by private and public

25 entities as the Panel’s official code sets for use
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1 in a national uniform working file system. The

2 proposed regulations developed by the Panel

3 shall provide that any changes or updates to

4 such code sets that are established or requested

5 by the private or public entity which maintains

6 the code set—

7 ‘‘(i) shall preserve the informational

8 value of data retained either within the

9 uniform working file system or within the

10 information systems of parties making use

11 of the data and transactions standards,

12 conventions, and requirements;

13 ‘‘(ii) shall include instructions on how

14 existing data containing such codes is to be

15 converted or translated so as to preserve

16 its value;

17 ‘‘(iii) shall be incorporated into the of18 ficial code set in such a manner as to mini19 mize the disruption to the national uniform

20 working file system and minimize the cost

21 to all entities within the system for

22 reprogramming to accommodate such

23 changes or updates; and

24 ‘‘(iv) shall be implemented—
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1 ‘‘(I) only after at least 90 days

2 advance notice has been provided to

3 participants in the health care system;

4 and

5 ‘‘(II) no more frequently than on

6 an annual basis.

7 ‘‘(4) ESTABLISHMENT OF UNIQUE IDENTIFI8 ERS.—

9 ‘‘(A) IN GENERAL.—Not later than 9

10 months after the date of the enactment of this

11 section the Panel shall develop unique identifi12 ers for each participant in the health care sys13 tem.

14 ‘‘(B) SPECIAL RULES.—

15 ‘‘(i) INDIVIDUALS.—Each individual

16 shall have a unique identifier developed by

17 the Panel.

18 ‘‘(ii) HEALTH CARE BENEFIT PLANS

19 OR PROVIDERS.—In developing unique

20 identifiers for each health insurance plan

21 or provider, the Panel shall take into ac22 count multiple uses for such identifiers and

23 shall consider multiple physical locations

24 and specialty classifications for providers.

25 The unique identifiers for health insurance
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1 plans or providers may be based on the

2 system used under title XVIII on the date

3 of the enactment of this section.

4 ‘‘(5) PRIVACY AND CONFIDENTIALITY STAND5 ARDS.—

6 ‘‘(A) IN GENERAL.—Not later than 9

7 months after the date of the enactment of this

8 section the Panel, after taking into consider9 ation the Insurance Information and Privacy

10 Protection Model Act of the National Associa11 tion of Insurance Commissioners, other model

12 legislation, and international guidelines, shall

13 develop requirements which protect the privacy

14 of participants in the health care system and

15 ensure the confidentiality of information in the

16 data interchange system.

17 ‘‘(B) PRINCIPLES CONSIDERED.—In devel18 oping the requirements referred to in subpara19 graph (A), the Panel shall take into consider20 ation the following principles:

21 ‘‘(i) Information relating to an identi22 fiable or identified individual should be col23 lected only to the extent necessary to carry

24 out the purpose for which the information

25 is collected.
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1 ‘‘(ii) Information relating to an identi2 fiable or identified individual collected for

3 a particular purpose should generally not

4 be used for another purpose without the

5 individual’s informed consent unless the

6 pooling of information renders an individ7 ual’s data unidentifiable.

8 ‘‘(iii) Information relating to an iden9 tifiable or identified individual should be

10 disposed of when no longer necessary to

11 carry out the purpose for which it was col12 lected, unless the pooling of information

13 renders an individual’s data unidentifiable.

14 ‘‘(iv) Methods to ensure the verifi15 ability, timeliness, accuracy, reliability,

16 utility, completeness, relevance, and com17 parability of information relating to an

18 identifiable or identified individual should

19 be instituted.

20 ‘‘(v) An individual should be notified

21 in advance of the collection of information

22 relating to such individual with regard

23 to—

24 ‘‘(I) whether the furnishing of in25 formation is mandatory or voluntary;
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1 ‘‘(II) the recordkeeping practices

2 with respect to any information pro3 vided; and

4 ‘‘(III) the uses to be made of any

5 information provided.

6 ‘‘(vi) If informed consent is necessary

7 for the intended primary or secondary use

8 of information relating to an identifiable or

9 identified individual, the individual should

10 be provided the opportunity to reject such

11 uses at the time the information is col12 lected, except where such uses are nec13 essary to comply with law.

14 ‘‘(vii) An individual should be per15 mitted to inspect and correct any informa16 tion which concerns such individual and

17 should be able to obtain information on

18 how such information is being used.

19 ‘‘(6) TRANSFER OF INFORMATION BETWEEN

20 HEALTH BENEFIT PLANS.—Not later than 9 months

21 after the date of the enactment of this section, the

22 Panel shall develop rules and procedures—

23 ‘‘(A) for determining the financial liability

24 of health benefit plans when health care bene-
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1 fits are payable under two or more health bene2 fit plans; and

3 ‘‘(B) concerning the transfer among health

4 benefit plans of appropriate official data sets

5 needed to carry out the coordination of benefits,

6 the sequential processing of claims, and other

7 health data as determined necessary by the

8 Panel for individuals who have more than one

9 health care benefit plan, according to the prior10 ities established under the rules and procedures

11 established under subparagraph (A).

12 ‘‘(7) FINES AND PENALTIES FOR FAILURE TO

13 COMPLY.—

14 ‘‘(A) COMPLIANCE WITH STANDARDS FOR

15 PRIVACY AND CONFIDENTIALITY.—Not later

16 than 9 months after the date of the enactment

17 of this section the Panel shall develop civil fines

18 and penalties, as determined appropriate by the

19 Panel, to enforce any of the requirements devel20 oped by the Panel under paragraph (5) relating

21 to privacy and confidentiality. The civil pen22 alties developed by the Panel under this sub23 paragraph shall not be less than $1,000 for

24 each violation.
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1 ‘‘(B) COMPLIANCE WITH OTHER REQUIRE2 MENTS.—

3 ‘‘(i) IN GENERAL.—Not later than 9

4 months after the date of the enactment of

5 this section the Panel shall develop civil

6 fines and penalties, as determined appro7 priate by the Panel, to enforce any of the

8 requirements developed by this Panel

9 under this section other than the require10 ments related to privacy and confidential11 ity. The civil fines and penalties developed

12 by the Panel under this subparagraph shall

13 not exceed $100 for each violation.

14 ‘‘(ii) LIMITATIONS.—

15 ‘‘(I) PENALTIES NOT TO APPLY

16 WHERE NONCOMPLIANCE NOT DISCOV17 ERED EXERCISING REASONABLE DILI18 GENCE.—No civil fine or penalty de19 veloped by the Panel under this sub20 paragraph shall be imposed if it is es21 tablished that the person liable for the

22 fine or penalty did not know, and by

23 exercising reasonable diligence would

24 not have known, that such person
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1 failed to comply with any of the re2 quirements described in clause (i).

3 ‘‘(II) PENALTIES NOT TO APPLY

4 TO COMPLIANCE FAILURES COR5 RECTED WITHIN 30 DAYS.—No civil

6 fine or penalty developed by the Panel

7 under this subparagraph shall be im8 posed if—

9 ‘‘(aa) the failure to comply

10 was due to reasonable cause and

11 not to willful neglect, and

12 ‘‘(bb) the failure to comply

13 is corrected during the 30-day

14 period beginning on the 1st date

15 the person liable for the fine or

16 penalty knew, or by exercising

17 reasonable diligence would have

18 known, that the failure to comply

19 occurred.

20 ‘‘(III) WAIVER.—In the case of a

21 failure to comply which is due to rea22 sonable cause and not to willful ne23 glect, any civil fine or penalty devel24 oped by the Panel under this subpara25 graph may be waived to the extent
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1 that the payment of such fine or pen2 alty would be excessive relative to the

3 compliance failure involved.

4 ‘‘(j) REPORTS TO THE CONGRESS.—

5 ‘‘(1) LEGISLATIVE PROPOSAL ON CERTAIN

6 CRIMINAL FINES AND PENALTIES.—Not later than

7 12 months after the date of the enactment of this

8 section the Panel shall submit to the Congress a leg9 islative proposal relating to any criminal fines and

10 penalties determined appropriate by the Panel to en11 force any of the requirements developed by the Panel

12 under paragraph (5) relating to privacy and con13 fidentiality.

14 ‘‘(2) ANNUAL REPORTS.—

15 ‘‘(A) IN GENERAL.—The Panel shall annu16 ally prepare and submit to Congress a report

17 on—

18 ‘‘(i) the status of the data interchange

19 system, including the system’s ability to

20 provide data on cost, quality, and patient

21 satisfaction;

22 ‘‘(ii) the savings and costs of imple23 menting the data interchange system; and

24 ‘‘(iii) any legislative recommendations

25 related to the data interchange system.
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1 ‘‘(B) AVAILABILITY TO THE PUBLIC.—Any

2 information in the report submitted to Congress

3 under subparagraph (A) shall be made available

4 to the public unless such information may not

5 be disclosed by law.

6 ‘‘(k) OVERSIGHT OF UNIFORM WORKING FILE,

7 HEALTH CARE INFORMATION CLEARINGHOUSES, AND

8 VALUE ADDED NETWORKS.—

9 ‘‘(1) PERIODIC REVIEWS.—Not later than 9

10 months after the date of the enactment of this sec11 tion the Secretary shall establish a procedure for the

12 periodic review of business practices, performance,

13 and fees with respect to the uniform working file

14 and each health care information clearinghouse and

15 value added network to ensure that such entities are

16 not taking unfair advantage of participants in the

17 health care system through the application of any

18 regulations promulgated by OMB under subsection

19 (g).

20 ‘‘(2) CERTIFICATION PROCEDURE.—Not later

21 than 12 months after the date of the enactment of

22 this section the Panel shall establish a certification

23 procedure for the uniform working file, health care

24 information clearinghouses, and value added net-
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1 works. The requirements for certification shall in2 clude—

3 ‘‘(A) adherence to the data and transaction

4 standards and requirements and the privacy

5 and confidentiality standards included in any

6 regulations promulgated by OMB under sub7 section (g);

8 ‘‘(B) making public standardized indica9 tors of performance such as accessibility, trans10 action responsiveness, administrative efficiency,

11 reliability, dependability, and any other indica12 tors determined appropriate by the Secretary;

13 and

14 ‘‘(C) any other requirements determined

15 appropriate by the Secretary.

16 ‘‘(l) DEFINITIONS.—For purposes of this section:

17 ‘‘(1) PARTICIPANT IN THE HEALTH CARE SYS18 TEM.—

19 ‘‘(A) IN GENERAL.—The term ‘participant

20 in the health care system’ means any Federal

21 health care program, State, administrator, em22 ployee welfare benefit plan, health insurance

23 plan, insurer, or provider.

24 ‘‘(B) ADMINISTRATOR.—The term ‘admin25 istrator’ has the meaning given that term in
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1 section 3(16)(A) of the Employee Retirement

2 Income Security Act of 1974.

3 ‘‘(C) EMPLOYEE WELFARE BENEFIT

4 PLAN.—The term ‘employee welfare benefit

5 plan’ has the meaning given that term in sec6 tion 3(1) of the Employee Retirement Income

7 Security Act of 1974.

8 ‘‘(D) HEALTH INSURANCE PLAN.—The

9 term ‘health insurance plan’ means any con10 tract or arrangement under which an entity

11 bears all or part of the cost of providing health

12 care items and services, including a hospital or

13 medical expense incurred policy or certificate,

14 hospital or medical service plan contract, or

15 health maintenance subscriber contract (includ16 ing any self-insured health insurance plan).

17 ‘‘(E) INSURER.—The term ‘insurer’ means

18 any entity that offers a health insurance plan

19 under which such entity is at risk for all or part

20 of the cost of benefits under the plan, and in21 cludes any agent of such entity.

22 ‘‘(F) PROVIDER.—The term ‘provider’

23 means a physician, hospital, pharmacy, labora24 tory, or other person licensed or otherwise au-
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1 thorized under applicable State laws to furnish

2 health care items or services.

3 ‘‘(G) STATE.—The term ‘State’ has the

4 meaning given to such term by section

5 1101(a)(1).

6 ‘‘(2) HEALTH CARE INFORMATION CLEARING7 HOUSE.—The term ‘health care information clear8 inghouse’ means a public or private entity that—

9 ‘‘(A) processes data that cannot be sent di10 rectly due to lack of proper formatting or edit11 ing; and

12 ‘‘(B) facilitates the translation of data to

13 the standardized data set and code sets between

14 persons who normally would send or receive the

15 transaction;

16 but does not store information processed beyond the

17 time required to complete its task and communicate

18 the information.

19 ‘‘(3) HEALTH CARE VALUE ADDED NET20 WORK.—The term ‘health care value added network’

21 means any entity that provides additional services

22 beyond the transmission of data or value, such as

23 the storage of electronic data or value and the trans24 fer of such data or value between health care enti25 ties.
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1 ‘‘(4) CODE SETS.—The term ‘code sets’ means

2 any codes used for supplying specific data in a uni3 form data set, including tables of terms, medical di4 agnostic codes, medical procedure codes, identifica5 tion numbers, and any code sets of the National

6 Uniform Billing Committee, the Health Care Fi7 nancing Administration, or ANSI.

8 ‘‘NATIONAL HEALTH INFORMATICS COMMISSION

9 ‘‘SEC. 2102. (a) APPOINTMENT.—The Health Care

10 Data Interchange Panel (referred to in this section as the

11 ‘Panel’) shall provide for appointment of a National

12 Health Informatics Commission (referred to in this section

13 as the ‘Commission’) to advise the Panel on its activities.

14 ‘‘(b) MEMBERSHIP.—

15 ‘‘(1) IN GENERAL.—The Commission shall con16 sist of 15 members. The Panel shall designate 1

17 member of the Commission as the Chairperson.

18 ‘‘(2) EXPERTISE.—Members of the Commission

19 shall be individuals who—

20 ‘‘(A) represent different professions and

21 different geographic areas, including urban and

22 rural areas;

23 ‘‘(B) represent Federal or State govern24 ment health programs;

25 ‘‘(C) represent applicable standard-setting

26 groups, including the National Uniform Billing
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1 Committee, the Uniform Claim Form Task

2 Force, American National Standards Institute,

3 and the Healthcare Informatics Standards

4 Planning Panel;

5 ‘‘(D) represent consumers of health care

6 services; and

7 ‘‘(E) have expertise in—

8 ‘‘(i) electronic data interchange of

9 health care information and computerized

10 information systems associated with the

11 operation and administration of matters

12 relating to health care;

13 ‘‘(ii) the provision and financing of

14 health care;

15 ‘‘(iii) conducting and interpreting

16 health economics research;

17 ‘‘(iv) research and development of

18 technological and scientific advances in

19 health care;

20 ‘‘(v) health care eligibility, enrollment,

21 and claims administration;

22 ‘‘(vi) health care financial manage23 ment;

24 ‘‘(vii) health care reimbursement; or

25 ‘‘(viii) health care outcomes research.
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1 ‘‘(3) TERMS.—The Chairperson shall serve on

2 the Commission at the pleasure of the Panel. Each

3 other member of the Commission shall be appointed

4 for a term of 5 years, except with respect to the

5 members first appointed—

6 ‘‘(A) 3 members shall be appointed for a

7 term of 1 year;

8 ‘‘(B) 3 members shall be appointed for

9 terms of 2 years;

10 ‘‘(C) 3 members shall be appointed for

11 terms of 3 years;

12 ‘‘(D) 3 members shall be appointed for

13 terms of 4 years; and

14 ‘‘(E) 2 members shall be appointed for

15 terms of 5 years.

16 ‘‘(4) VACANCIES.—

17 ‘‘(A) IN GENERAL.—A vacancy on the

18 Commission shall be filled in the manner in

19 which the original appointment was made and

20 shall be subject to any conditions which applied

21 with respect to the original appointment.

22 ‘‘(B) FILLING UNEXPIRED TERM.—An in23 dividual chosen to fill a vacancy shall be ap24 pointed for the unexpired term of the member

25 replaced.
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1 ‘‘(C) EXPIRATION OF TERMS.—The term

2 of any member shall not expire before the date

3 on which the member’s successor takes office.

4 ‘‘(c) MEETINGS.—

5 ‘‘(1) IN GENERAL.—Except as provided in para6 graph (2), the Commission shall meet at the call of

7 the Chairperson.

8 ‘‘(2) INITIAL MEETING.—No later than 30 days

9 after the date on which all members of the Commis10 sion have been appointed, the Commission shall hold

11 its first meeting.

12 ‘‘(3) QUORUM.—A majority of the members of

13 the Commission shall constitute a quorum, but a

14 lesser number of members may hold hearings.

15 ‘‘(d) DUTIES.—

16 ‘‘(1) IN GENERAL.—Not later than 60 days

17 prior to any date on which the Panel is required to

18 select, establish, or develop any requirements relat19 ing to the data interchange system, the Commission

20 shall make recommendations to the Panel with re21 spect to the issues relating to such requirements.

22 ‘‘(2) ADDITIONAL STUDIES AND PROJECTS.—As

23 directed by the Panel, the Commission shall under24 take such studies and projects as the Panel may

25 deem necessary.
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1 ‘‘(e) POWERS OF THE COMMISSION.—

2 ‘‘(1) HEARINGS.—The Commission may hold

3 such hearings, sit and act at such times and places,

4 take such testimony, and receive such evidence as

5 the Commission considers advisable to carry out the

6 purposes of this section.

7 ‘‘(2) INFORMATION FROM FEDERAL AGEN8 CIES.—The Commission may secure directly from

9 any Federal department or agency such information

10 as the Commission considers necessary to carry out

11 the provisions of this section. Upon request of the

12 Chairperson, the head of such department or agency

13 shall furnish such information to the Commission.

14 ‘‘(3) POSTAL SERVICES.—The Commission may

15 use the United States mails in the same manner and

16 under the same conditions as other departments and

17 agencies of the Federal Government.

18 ‘‘(4) GIFTS.—The Commission may accept, use,

19 and dispose of gifts or donations of services or prop20 erty.

21 ‘‘(f) COMMISSION PERSONNEL MATTERS.—

22 ‘‘(1) COMPENSATION OF MEMBERS.—Each

23 member of the Commission who is not an officer or

24 employee of the Federal Government shall be com25 pensated at a rate equal to the daily equivalent of
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1 the annual rate of basic pay prescribed for level IV

2 of the Executive Schedule under section 5315 of title

3 5, United States Code, for each day (including travel

4 time) during which such member is engaged in the

5 performance of the duties of the Commission. All

6 members of the Commission who are officers or em7 ployees of the United States shall serve without com8 pensation in addition to that received for their serv9 ices as officers or employees of the United States.

10 ‘‘(2) TRAVEL EXPENSES.—The members of the

11 Commission shall be allowed travel expenses, includ12 ing per diem in lieu of subsistence, at rates author13 ized for employees of agencies under subchapter I of

14 chapter 57 of title 5, United States Code, while

15 away from their homes or regular places of business

16 in the performance of services for the Commission.

17 ‘‘(3) STAFF.—

18 ‘‘(A) IN GENERAL.—The Chairperson may,

19 without regard to civil service laws and regula20 tions, appoint and terminate such personnel as

21 may be necessary to enable the Commission to

22 perform its duties.

23 ‘‘(B) COMPENSATION.—The Chairperson

24 may fix the compensation of personnel without

25 regard to the provisions of chapter 51 and sub-
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1 chapter III of chapter 53 of title 5, United

2 States Code, relating to classification of posi3 tions and General Schedule pay rates, except

4 that the rate of pay for the personnel may not

5 exceed the rate payable for level V of the Exec6 utive Schedule under section 5316 of such title.

7 ‘‘(C) DETAIL OF GOVERNMENT EMPLOY8 EES.—Any Federal Government employee may

9 be detailed to the Commission without reim10 bursement, and such detail shall be without

11 interruption or loss of civil service status or

12 privilege.

13 ‘‘(D) PROCUREMENT OF TEMPORARY AND

14 INTERMITTENT SERVICES.—The Chairperson

15 may procure temporary and intermittent serv16 ices under section 3109(b) of title 5, United

17 States Code, at rates for individuals which do

18 not exceed the daily equivalent of the annual

19 rate of basic pay prescribed for level V of the

20 Executive Schedule under section 5316 of such

21 title.

22 ‘‘(E) CONTRACTS.—The Chairperson may

23 enter into contracts or other arrangements that

24 may be necessary for the Commission to per25 form its duties.
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1 ‘‘(F) INTERNAL ORGANIZATION.—The

2 Chairperson may prescribe such rules as the

3 Chairperson determines necessary with respect

4 to the internal organization of the Commission.

5 The Commission shall create such committees

6 (composed of Commission members and others

7 as appointed by the Chairperson) as necessary

8 to enable the Commission to meet its respon9 sibilities and functions.

10 ‘‘(g) REPORTS.—The Commission shall submit to the

11 Panel such reports as may be requested by the Panel on

12 each study or project conducted by the Commission. Such

13 reports shall contain such information as requested by the

14 Panel.

15 ‘‘(h) TERMINATION OF COMMISSION.—The Commis16 sion shall terminate 20 years after the date of the enact17 ment of this Act.

18 ‘‘(i) AUTHORIZATION OF APPROPRIATIONS.—

19 ‘‘(1) IN GENERAL.—There are authorized to be

20 appropriated such sums as may be necessary to

21 carry out the purposes of this section.

22 ‘‘(2) AVAILABILITY.—Any sums appropriated

23 under the authorization contained in this subsection

24 shall remain available, without fiscal year limitation,

25 until expended.’’.
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1 (b) EFFECTIVE DATE.—The amendments made by

2 subsection (a) shall be effective on the date of the enact3 ment of this Act.

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