II 

108TH CONGRESS 

2D SESSION S. 2421 

To modernize the health care system through the use of information technology and to reduce costs, improve quality, and provide a new focus 

on prevention with respect to health care. 

IN THE SENATE OF THE UNITED STATES 

MAY 13, 2004 

Mr. KENNEDY introduced the following bill; which was read twice and referred 

to the Committee on Health, Education, Labor, and Pensions 

A BILL 

To modernize the health care system through the use of 

information technology and to reduce costs, improve 

quality, and provide a new focus on prevention with 

respect to health care. 

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; TABLE OF CONTENTS. 

4 (a) SHORT TITLE.—This Act may be cited as the 

5 ‘‘Health Care Modernization, Cost Reduction, and Quality 

6 Improvement Act’’. 

7 (b) TABLE OF CONTENTS.—The table of contents of 

8 this Act is as follows: 
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Sec. 1. Short title; table of contents. 

TITLE I—INFORMATION TECHNOLOGY 

Subtitle A—Improving the Quality of Health Care Through Clinical 

Informatics 

Sec. 101. Improving the quality of health care through clinical informatics. 

Sec. 102. Reimbursement for operation of qualified clinical informatics system. 

Subtitle B—Reducing Administrative Costs and Improving Service Through 

Information Technology 

Sec. 111. Requirement for health insurers to implement computerized claims 

processing systems. 

Sec. 112. Making health care more responsive to the consumer. 

Sec. 113. Regulations. 

Subtitle C—Application to Public Health Service Act and Employee 

Retirement Income Security Act of 1974 

Sec. 121. Application to group health plans and group health insurance coverage under the Public Health Service Act. 

Sec. 122. Application to individual health insurance coverage under the Public 

Health Service Act. 

Sec. 123. Application to group health plans and group health insurance coverage under the Employee Retirement Income Security Act of 

1974. 

Subtitle D—Miscellaneous Provisions 

Sec. 131. Definitions. 

TITLE II—PAYING FOR PERFORMANCE 

Sec. 201. Health care provider quality standards. 

TITLE III—TARGETED QUALITY INITIATIVES 

Sec. 301. Improving the quality of care for Americans with diabetes. 

‘‘PART R—IMPROVING THE QUALITY OF CARE FOR AMERICANS WITH

DIABETES

‘‘Sec. 399A. State diabetes control and prevention programs. 

‘‘Sec. 399A–1. Improving quality of diabetes prevention and care. 

‘‘Sec. 399A–2. National diabetes education and outreach. 

‘‘Sec. 399A–3. Definition. 

Sec. 302. Improving the quality of care for Americans with arthritis. 

‘‘PART S—IMPROVING THE QUALITY OF CARE FOR AMERICANS WITH

ARTHRITIS

‘‘Sec. 399B. State arthritis control and prevention programs.

‘‘Sec. 399B–1. Comprehensive arthritis action grants.

‘‘Sec. 399B–2. National arthritis education and outreach.

‘‘Sec. 399B–3. Definition. 

Sec. 303. Stroke prevention, treatment, and rehabilitation. 
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‘‘PART T—STROKE PREVENTION, TREATMENT, AND REHABILITATION

PROGRAMS

‘‘Sec. 399C. Definitions. 

‘‘Sec. 399C–1. Grants to States for stroke care systems. 

‘‘Sec. 399C–2. Planning grants. 

‘‘Sec. 399C–3. Responsibilities of the secretary. 

Sec. 304. Increasing language access for Americans with limited English proficiency. 

‘‘PART C—INCREASING LANGUAGE ACCESS FOR AMERICANS WITH LIMITED

ENGLISH PROFICIENCY

‘‘Sec. 251. Improving access to services for individuals with limited 

English proficiency. 

‘‘Sec. 252. National standards for culturally and linguistically appropriate 

services in healthcare. 

‘‘Sec. 253. Innovations in language access grants. 

‘‘Sec. 254. Standards for language access services. 

‘‘Sec. 255. Report on Federal efforts to provide culturally and linguistically appropriate health care services. 

Sec. 305. Federal reimbursement for culturally and linguistically appropriate 

services. 

Sec. 306. National Quality Advisory Council. 

TITLE IV—PREVENTIVE HEALTH SERVICES 

Sec. 401. Increasing health insurance coverage for prevention. 

Sec. 402. Activities relating to nutrition and physical activity. 

‘‘PART U—PREVENTIVE HEALTH CARE

‘‘Sec. 399D. Encouraging consumption of healthy diets. 

‘‘Sec. 399D–1. Increasing physical activity. 

Sec. 403. Improving immunization. 

‘‘PART V—IMPROVING IMMUNIZATION

‘‘Sec. 399E. Programs to improve the rate of immunization in adults and 

adolescents. 

‘‘Sec. 399E–1. Curriculum development. 

‘‘Sec. 399E–2. Assuring adequate supply of vaccines for adult and adolescent immunization programs. 

‘‘Sec. 399E–3. Research on immunization programs. 

‘‘Sec. 399E–4. Definition. 

Sec. 404. Improving oral health. 

‘‘PART W—IMPROVING ORAL HEALTH

‘‘Sec. 399F. Public education. 

‘‘Sec. 399F–1. Health care provider education. 

‘‘Sec. 399F–2. Monitoring and evaluating the quality of oral health. 

‘‘Sec. 399F–3. Studies and reports by the Institute of Medicine. 

‘‘Sec. 399F–4. Definition. 
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•S 2421 IS 

1 TITLE I—INFORMATION 

2 TECHNOLOGY 

3 Subtitle A—Improving the Quality 

4 of Health Care Through Clinical 

5 Informatics 

6 SEC. 101. IMPROVING THE QUALITY OF HEALTH CARE 

7 THROUGH CLINICAL INFORMATICS. 

8 (a) GRANTS TO ENHANCE THE USE OF CLINICAL

9 INFORMATICS.— 

10 (1) IN GENERAL.—The Secretary shall award 

11 grants or cooperative agreements to eligible entities 

12 to assist such entities to acquire, develop, enhance, 

13 or implement (including the training of personnel 

14 needed for effective implementation) qualified clin15 ical informatics systems that are consistent with the 

16 technical standards promulgated by the Secretary 

17 under subsection (d). 

18 (2) DEFINITION.—In this section, the term 

19 ‘‘qualified clinical informatics system’’ means a com20 puterized system (including both hardware and soft21 ware components of such system) that— 

22 (A) maintains and provides immediate ac23 cess to patients’ medical records in an elec24 tronic format; 
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1 (B) permits a qualified practitioner who 

2 wishes to enter an order for a medication, treat3 ment, diagnostic procedure, or other interven4 tion or service to enter such order via a com5 puter that is linked to a database capable of ac6 cessing the medical record of the patient who is 

7 intended to receive such medication, treatment, 

8 diagnostic procedure, or other intervention; 

9 (C) incorporates error notification software 

10 so that a warning is generated by such system 

11 if an order is entered that is likely to lead to 

12 a significant adverse outcome for the patient; 

13 (D) provides information to a qualified 

14 practitioner regarding optimal or recommended 

15 alternatives to an order described in subpara16 graph (B), provided that such information is 

17 not primarily commercial in nature; 

18 (E) provides electronic alerts and remind19 ers to improve compliance with best practices, 

20 promote regular screenings and other preventive 

21 practices, and facilitate diagnoses and treat22 ments; 

23 (F) allows the secure electronic trans24 mission of information to other health care pro25 viders. 
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1 (3) GUIDANCE.—The Secretary, acting through 

2 the Director of the Agency for Healthcare Research 

3 and Quality and such other officials as may be ap4 propriate, shall provide technical guidance con5 cerning the elements described in paragraph (2). 

6 (4) ENTITIES ELIGIBLE FOR GRANTS OR COOP7 ERATIVE AGREEMENTS.—To be eligible to receive a 

8 grant or cooperative agreement under this sub9 section, an entity shall— 

10 (A) be a— 

11 (i) Federally qualified health center 

12 (as defined in section 1861(aa)(4) of the 

13 Social Security Act (42 U.S.C. 

14 1395x(aa)(4)); 

15 (ii) nonprofit hospital, health care 

16 clinic, skilled nursing facility, or other non17 profit health care facility determined by 

18 the Secretary to be eligible and to be in 

19 need of significant financial assistance to 

20 implement a qualified clinical informatics 

21 system; or 

22 (iii) group practice as defined in sec23 tion 1877(h)(4) of the Social Security Act 

24 (42 U.S.C. 1395nn(h)(4)), including a 

25 practice that meets the requirements of 
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•S 2421 IS 

1 such section except that such practice has 

2 only one physician, and that is in need of 

3 significant assistance to implement a quali4 fied clinical informatics system; 

5 (B) prepare and submit to the Secretary 

6 an application at such time, in such manner, 

7 and containing such information as the Sec8 retary may require, including a description of 

9 the qualified clinical informatics system that 

10 the entity intends to implement using amounts 

11 received under paragraph (1); and 

12 (C) submit assurances satisfactory to the 

13 Secretary that the entity will conduct the qual14 ity improvement activities described in sub15 section (e)(1)(A) and subsection (e)(1)(B) if ap16 plicable. 

17 (5) MATCHING REQUIREMENT.—The Secretary 

18 may not make an award under paragraph (1) to an 

19 entity described in paragraph (4)(A) unless that en20 tity agrees that, with respect to the costs to be in21 curred by the entity in carrying out the activities for 

22 which the grant or cooperative agreement is being 

23 awarded, the entity will make available (directly or 

24 through donations from public or private entities) 
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•S 2421 IS 

1 non-Federal contributions toward such costs in an 

2 amount equal to— 

3 (A) with respect to an entity described in 

4 paragraph (4)(A)(i), $1 for each $10 of Federal 

5 funds provided under the grant or cooperative 

6 agreement; and 

7 (B) with respect to an entity described in 

8 paragraph (4)(A)(ii) or (iii), $1 for each $5 of 

9 Federal funds provided under the grant or co10 operative agreement. 

11 (b) REVOLVING LOAN FUND TO ENHANCE CLINICAL

12 INFORMATICS.— 

13 (1) ESTABLISHMENT OF REVOLVING LOAN

14 FUND.—The Secretary shall establish a revolving 

15 loan fund— 

16 (A) from which the Secretary shall make 

17 loans (subject to the conditions described in 

18 paragraph (3)) to eligible entities to assist such 

19 entities to acquire, develop, enhance, or imple20 ment (including the training of personnel need21 ed for effective implementation) qualified clin22 ical informatics systems that are consistent 

23 with the technical standards promulgated by 

24 the Secretary under subsection (d); and 
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1 (B) into which all payments, interest, 

2 charges, and other amounts collected from 

3 loans made under subparagraph (A) shall, not4 withstanding any other provision of law, be de5 posited. 

6 (2) ELIGIBLE ENTITIES.—To be eligible to re7 ceive a loan under this subsection, an entity shall— 

8 (A) be a— 

9 (i) nonprofit hospital, health care clin10 ic, community health center, skilled nurs11 ing facility, or other nonprofit health care 

12 facility; or 

13 (ii) group practice as defined in sec14 tion 1877(h)(4) of the Social Security Act 

15 (42 U.S.C. 1395nn(h)(4)), including a 

16 practice that meets the requirements of 

17 such section except that such practice has 

18 only one physician; 

19 (B) prepare and submit to the Secretary 

20 an application at such time, in such manner, 

21 and containing such information as the Sec22 retary may require, including a description of 

23 the qualified clinical informatics system that 

24 the entity intends to implement using amounts 

25 received under paragraph (1); and 
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1 (C) submit assurances satisfactory to the 

2 Secretary that the entity will conduct the qual3 ity improvement activities described in sub4 section (e)(1)(A) and subsection (e)(1)(B) if ap5 plicable. 

6 (3) CONDITIONS OF LOANS.— 

7 (A) IN GENERAL.—Each loan under this 

8 subsection shall be made at a rate of interest 

9 that is the greater of— 

10 (i) a rate that is 3 percentage points 

11 below the rate of interest payable on obli12 gations of the Federal Government having 

13 terms of maturity of 10 years; or 

14 (ii) zero. 

15 (B) TERM.—Each loan made under this 

16 subsection shall be for a term that does not ex17 ceed 7 years. 

18 (C) REPAYMENT.—The Secretary may not 

19 make a loan to an eligible entity under this sub20 section unless the Secretary determines that 

21 there is a reasonable expectation that the entity 

22 will repay the loan according to the terms of 

23 the loan. 

24 (D) COLLATERAL.—The Secretary may re25 quire an eligible entity receiving a loan under 
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•S 2421 IS 

1 this subsection to provide such collateral as the 

2 Secretary determines to be necessary to secure 

3 the loan. 

4 (E) DEFAULTS AND COLLECTIONS.—Prior 

5 to making a loan under this subsection, the 

6 Secretary shall establish written procedures and 

7 definitions relating to defaults and collections of 

8 payments on such loans and shall provide to 

9 each applicant for such a loan, at the time of 

10 the application, a written copy of such proce11 dures and definitions. 

12 (F) REGULATIONS.—The Secretary may 

13 promulgate such other regulations as may be 

14 necessary to carry out the purposes of this sub15 section, including regulations involving report16 ing and auditing. 

17 (4) SEPARATE ACCOUNT AND INVESTMENTS.— 

18 The revolving loan fund established under this sub19 section shall be maintained by the Secretary as a 

20 separate account. Any portion of the revolving loan 

21 fund that is not required for expenditure shall be in22 vested in obligations of the United States or in obli23 gations guaranteed or insured by the United States. 

24 (c) LOAN GUARANTEES.— 
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•S 2421 IS 

1 (1) IN GENERAL.—The Secretary shall establish 

2 a program under which the Secretary may guarantee 

3 up to 90 percent of the principal and interest on 

4 loans made by non-Federal lenders to eligible enti5 ties for the costs of acquiring qualified clinical 

6 informatics systems. 

7 (2) ELIGIBLE ENTITIES.—To be eligible to re8 ceive a loan guarantee under this subsection, an en9 tity shall— 

10 (A) be a— 

11 (i) nonprofit hospital, health care clin12 ic, community health center, skilled nurs13 ing facility, or other nonprofit health care 

14 facility; or 

15 (ii) group practice as defined in sec16 tion 1877(h)(4) of the Social Security Act 

17 (42 U.S.C. 1395nn(h)(4)), including a 

18 practice that meets the requirements of 

19 such section except that such practice has 

20 only one physician; 

21 (B) prepare and submit to the Secretary 

22 an application at such time, in such manner, 

23 and containing such information as the Sec24 retary may require, including a description of 

25 the qualified clinical informatics system that 
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•S 2421 IS 

1 the entity intends to implement using amounts 

2 received under paragraph (1); and 

3 (C) submit assurances satisfactory to the 

4 Secretary that the entity will conduct the qual5 ity improvement activities described in sub6 section (e)(1)(A) and subsection (e)(1)(B) if ap7 plicable. 

8 (3) USE OF FUNDS.—Loan funds guaranteed 

9 under this subsection may be used to acquire quali10 fied clinical informatics systems that are consistent 

11 with the technical standards promulgated by the 

12 Secretary under subsection (d). 

13 (4) CONDITIONS OF LOAN.—Guarantees of 

14 loans under this subsection shall be subject to such 

15 further terms and conditions as the Secretary deter16 mines to be necessary to assure that the purposes of 

17 this subsection will be achieved. 

18 (d) PROMULGATION OF TECHNICAL STANDARDS.— 

19 Not later than January 1, 2006, the Secretary shall de20 velop or adopt technical standards for qualified clinical 

21 informatics systems relating to— 

22 (1) interoperability; 

23 (2) security; 

24 (3) the protection of confidentiality, consistent 

25 with the regulations promulgated under section 
14 

•S 2421 IS 

1 264(c) of the Health Insurance Portability and Ac2 countability Act (42 U.S.C. 1320d–2 note); and 

3 (4) such other subjects determined appropriate 

4 by the Secretary. 

5 (e) QUALITY IMPROVEMENT ACTIVITIES.— 

6 (1) IN GENERAL.—As used in this section, the 

7 term ‘‘quality improvement activities’’ means— 

8 (A) the use of a qualified clinical 

9 informatics system to report data on the health 

10 care quality standards developed under section 

11 201 of this Act to a utilization and quality con12 trol peer review organization with a contract 

13 under part B of title XI of the Social Security 

14 Act (42 U.S.C. 1320c et seq.), or to any other 

15 patient safety organization recognized by the 

16 Secretary, and to the Secretary in a manner 

17 consistent with the standards developed under 

18 the regulations promulgated under section 

19 264(c) of the Health Insurance Portability and 

20 Accountability Act (42 U.S.C. 1320d–2 note); 

21 and 

22 (B) with respect to a health care provider 

23 that employs more than 50 physicians (as such 

24 term is defined in 1861(r) of the Social Secu25 rity Act (42 U.S.C. 1395x(r)) or that is a hos-
15 

•S 2421 IS 

1 pital or other institutional provider, the imple2 mentation of a program to— 

3 (i) analyze (through a process that 

4 may include the receipt of analyses con5 ducted by other appropriate entities) data 

6 on the quality of health care provided by 

7 such provider; and 

8 (ii) institute measures, based on the 

9 analysis conducted under clause (i), to im10 prove the quality of health care provided 

11 by such provider. 

12 (2) PUBLIC AVAILABILITY OF DATA ON QUAL13 ITY IMPROVEMENT.—The Secretary shall analyze 

14 and make publicly available the data reported to the 

15 Secretary under paragraph (1)(A) in a manner de16 termined to be of value to patients and health care 

17 practitioners. 

18 (f) REQUIREMENTS FOR STANDARDS.— 

19 (1) CONSULTATION.—In developing the tech20 nical standards under subsection (d), the Secretary 

21 shall consult with participants in the Consolidated 

22 Health Informatics initiative, or any successor to 

23 such initiative, and with public and private entities 

24 determined appropriate by the Secretary. In devel25 oping the standards under subsection (d), the Sec-
16 

•S 2421 IS 

1 retary shall take into consideration applicable rec2 ommendations of— 

3 (A) the National Committee on Vital and 

4 Health Statistics; and 

5 (B) the Consolidated Health Informatics 

6 initiative or any successor to such initiative. 

7 (2) OBJECTIVE.—Any standard developed or 

8 adopted under subsection (d) shall be consistent with 

9 the objectives of improving— 

10 (A) patient safety; and 

11 (B) the quality of care provided to pa12 tients. 

13 (3) CONSISTENCY.—The Secretary shall ensure 

14 that, to the maximum extent practicable, the stand15 ards adopted or developed under subsection (d) shall 

16 be consistent with— 

17 (A) any standards otherwise adopted or de18 veloped by the Secretary under the Social Secu19 rity Act for transactions and data elements to 

20 enable the electronic transmission of prescrip21 tions; and 

22 (B) any standards adopted by the Consoli23 dated Health Informatics initiative, or any suc24 cessor to such initiative. 
17 

•S 2421 IS 

1 (4) ADDITIONS AND MODIFICATIONS TO STAND2 ARDS.—Not later than January 1, 2007, and annu3 ally thereafter, the Secretary shall review the stand4 ards developed or adopted under subsection (d), and 

5 may modify such standards and measures if deter6 mined appropriate. Any addition or modification to 

7 such standards shall be completed in a manner 

8 which minimizes the disruption and cost of compli9 ance. 

10 (g) RESPONSIBILITIES OF THE SECRETARY.— 

11 (1) RESEARCH ON EFFECTIVENESS.—The Sec12 retary shall conduct research on a representative 

13 sample of entities receiving awards under sub14 sections (a), (b), and (c) to determine the extent to 

15 which qualified clinical informatics systems imple16 mented by such entities have improved the quality of 

17 care provided to patients receiving care from such 

18 entities and reduced the costs of providing high 

19 quality health care. 

20 (2) TECHNICAL ASSISTANCE.—The Secretary 

21 shall provide such technical assistance as is feasible 

22 to eligible entities in carrying out activities under 

23 this section. 
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•S 2421 IS 

1 (3) USE OF TECHNOLOGY SYSTEMS AND ELEC2 TRONIC PAYMENT OF CLAIMS.—The Secretary shall, 

3 to the extent technically practicable— 

4 (A) utilize information technology systems 

5 for— 

6 (i) processing financial transactions; 

7 (ii) providing reimbursement to pro8 viders; 

9 (iii) adjudicating claims for reim10 bursement; and 

11 (iv) providing statements of account 

12 or explanations of benefits to providers; 

13 and 

14 (B) require the submission of claims for 

15 payment via electronic means. 

16 (4) CONSISTENCY WITH STANDARDS.—Begin17 ning on January 1, 2006, the Secretary may not 

18 purchase information technology systems unless such 

19 systems are consistent with the applicable standards 

20 developed under subsection (d). 

21 (h) AUTHORIZATION OF APPROPRIATIONS.—There 

22 are authorized to be appropriated to carry out this section, 

23 such sums as may be necessary. 
19 

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1 SEC. 102. REIMBURSEMENT FOR OPERATION OF QUALI2 FIED CLINICAL INFORMATICS SYSTEM. 

3 (a) INCREASED REIMBURSEMENT FOR OPERATING

4 CLINICAL INFORMATICS SYSTEM.— 

5 (1) IN GENERAL.—The Secretary shall increase, 

6 by the amount specified in paragraph (2), the reim7 bursement provided under any Federal health pro8 gram to any provider that— 

9 (A) operates a qualified clinical informatics 

10 system that is consistent with the technical 

11 standards promulgated under section 101(d); 

12 and 

13 (B) conducts the quality improvement ac14 tivities described in section 101(e)(1)(A) and 

15 section 101(e)(1)(B) if applicable. 

16 (2) AMOUNT OF INCREASED REIMBURSE17 MENT.—The amount of the increase in a reimburse18 ment under paragraph (1) shall be equal to— 

19 (A) for fiscal year 2005, 1 percent of the 

20 amount of the reimbursement involved; 

21 (B) for fiscal year 2006, 0.8 percent of the 

22 amount of the reimbursement involved; 

23 (C) for fiscal year 2007, 0.6 percent of the 

24 amount of the reimbursement involved; 

25 (D) for fiscal year 2008, 0.4 percent of the 

26 amount of the reimbursement involved; and 
20 

•S 2421 IS 

1 (E) for fiscal year 2009, 0.2 percent of the 

2 amount of the reimbursement involved. 

3 (b) DECREASED REIMBURSEMENT FOR FAILURE TO

4 OPERATE A CLINICAL INFORMATICS SYSTEM.— 

5 (1) IN GENERAL.—The Secretary shall de6 crease, by the amount specified in paragraph (2), 

7 the reimbursement provided under any Federal 

8 health program to any provider unless such pro9 vider— 

10 (A) operates a qualified clinical informatics 

11 system that is consistent with the technical 

12 standards promulgated under section 101(d); 

13 and 

14 (B) conducts the quality improvement ac15 tivities described in section 101(e)(1)(A) and 

16 section 101(e)(1)(B) if applicable. 

17 (2) AMOUNT OF DECREASED REIMBURSE18 MENT.—The amount of the decrease in a reimburse19 ment under paragraph (1) shall be equal to— 

20 (A) for fiscal year 2010, 0.2 percent of the 

21 amount of the reimbursement involved; 

22 (B) for fiscal year 2011, 0.4 percent of the 

23 amount of the reimbursement involved; 

24 (C) for fiscal year 2012, 0.6 percent of the 

25 amount of the reimbursement involved; 
21 

•S 2421 IS 

1 (D) for fiscal year 2013, 0.8 percent of the 

2 amount of the reimbursement involved; and 

3 (E) for fiscal year 2014, and each subse4 quent fiscal year, 1.0 percent of the amount of 

5 the reimbursement involved. 

6 (c) LIMITATION.—Subsection (b) shall not apply to 

7 any provider that employs less than 50 health care profes8 sionals. 

9 Subtitle B—Reducing Administra10 tive Costs and Improving Serv11 ice Through Information Tech12 nology 

13 SEC. 111. REQUIREMENT FOR HEALTH INSURERS TO IM14 PLEMENT COMPUTERIZED CLAIMS PROC15 ESSING SYSTEMS. 

16 (a) IN GENERAL.—Not later than December 31, 

17 2008, each group health plan and health insurance issuer 

18 offering health insurance coverage shall have in effect an 

19 automated, integrated system that allows for efficient and 

20 effective adjudication of claims and the detection of fraud 

21 and abuse in accordance with this section. 

22 (b) ELEMENTS OF ADJUDICATION.—The system de23 scribed in subsection (a) shall include determinations con24 cerning payments and coverage for items or services under 

25 the terms and conditions of the plan or coverage involved, 
22 

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1 including any cost-sharing amount that the participant, 

2 beneficiary, or enrollee is required to pay with respect to 

3 such claim. 

4 (c) TIMEFRAME.—The plan or issuer shall complete 

5 the adjudication of claims under this section immediately 

6 after the plan or issuer receives— 

7 (1) the claim; and 

8 (2) any additional information requested by the 

9 plan or issuer that is necessary to make a deter10 mination relating to the claim. 

11 (d) ACCURACY.—In adjudicating claims under this 

12 section the plan or issuer shall ensure that— 

13 (1) such claims are adjudicated with an accu14 racy of at least 99 percent; 

15 (2) the plan or issuer has the ability to accept 

16 claims submitted via the Internet; and 

17 (3) the plan or issuer has the ability to issue 

18 denials where necessary instantaneously via the 

19 Internet, and to provide an opportunity for challenge 

20 to and resolution of such denials (except in cases of 

21 dispute over medical necessity) via the Internet. 

22 (e) DETECTION SYSTEM.—Not later than December 

23 31, 2008, each group health plan and health insurance 

24 issuer offering health insurance coverage shall use the sys25 tem described in subsection (a) to detect fraud and abuse 
23 

•S 2421 IS 

1 in real-time as part of the adjudication of claims under 

2 this section. 

3 (f) REGULATIONS.—The Secretary shall issue such 

4 regulations as may be necessary or appropriate to carry 

5 out this section. 

6 SEC. 112. MAKING HEALTH CARE MORE RESPONSIVE TO 

7 THE CONSUMER. 

8 (a) STATEMENT OF ACCOUNT FOR CONSUMERS.— 

9 (1) IN GENERAL.—Not later than December 31, 

10 2008, each group health plan and health insurance 

11 issuer offering health insurance coverage shall have 

12 in effect a computerized system that provides each 

13 participant, beneficiary, or enrollee with a statement 

14 of account that— 

15 (A) includes information, with respect to 

16 the participant, beneficiary, or enrollee, on— 

17 (i) claims received, claims denied, and 

18 the reasons for any denials; 

19 (ii) status of coverage; and 

20 (iii) deductible information; and 

21 (B) is issued quarterly. 

22 (2) INTERNET ACCESS.—The plan or issuer 

23 may comply with this subsection by making the 

24 quarterly statements available on the Internet 24 

25 hours a day, 7 days a week, through a secure website. 
24 

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1 (b) STATEMENT OF ACCOUNT FOR EMPLOYERS AND

2 PURCHASES.—Not later than December 31, 2008, each 

3 group health plan and health insurance issuer shall have 

4 in effect a computerized system to provide to employers 

5 and other purchasers of health insurance products a state6 ment of account that— 

7 (1) includes— 

8 (A) current information on coverage sta9 tus; and 

10 (B) reports of customer satisfaction that 

11 are updated annually; and 

12 (2) is available 24 hours a day, 7 days a week, 

13 through— 

14 (A) the Internet through a secure website; 

15 or 

16 (B) a toll-free telephone number. 

17 (c) INTERNET ENROLLMENT.— 

18 (1) IN GENERAL.—Not later than December 31, 

19 2008, each group health plan and health insurance 

20 issuer shall have in effect a computerized system to 

21 provide to employers and other purchasers of health 

22 insurance products an option to enroll for coverage 

23 under such health insurance products on the Inter24 net through a secure website. 
25 

•S 2421 IS 

1 (2) ELIGIBILITY REQUIREMENTS.—The Inter2 net website described in paragraph (1) shall include 

3 information on eligibility requirements for coverage. 

4 (d) CONSUMER EXPLANATION OF BENEFITS.— 

5 (1) IN GENERAL.—Not later than December 31, 

6 2008, each group health plan and health insurance 

7 issuer shall have in effect a computerized system to 

8 provide, to a participant, beneficiary, or enrollee— 

9 (A) an explanation of benefits at the point 

10 of service or not later than 48 hours after the 

11 time that service is provided; and 

12 (B) a description of the coverage and cost 

13 of each services provided to the participant, 

14 beneficiary, or enrollee under the plan or cov15 erage. 

16 (2) LANGUAGE.—Any explanation of benefits 

17 under this subsection shall be provided in a printed 

18 form and written in a manner calculated to be un19 derstood by the average participant, beneficiary, or 

20 enrollee. 

21 (e) REFERRALS AND AUTHORIZATIONS.— 

22 (1) IN GENERAL.—Not later than December 31, 

23 2008, each group health plan and health insurance 

24 issuer shall have in effect a computerized system for 

25 making and checking referrals and pre-authoriza-
26 

•S 2421 IS 

1 tions where such referrals and pre-authorizations are 

2 required under the plan or coverage. 

3 (2) ACCESS.—The system described in para4 graph (1) shall permit access by physicians and by 

5 participants, beneficiaries, and enrollees to informa6 tion on the completion of referrals and pre-author7 izations and whether health care services and prod8 ucts have been authorized, through— 

9 (A) the Internet through a secure website; 

10 or 

11 (B) a toll-free telephone number. 

12 (f) MODERNIZING FINANCIAL TRANSACTIONS IN

13 HEALTH CARE.—Not later than December 31, 2008, each 

14 group health plan and health insurance issuer offering 

15 health insurance coverage shall have in effect a computer16 ized system that— 

17 (1) permits health care providers to receive 

18 claim payments through electronic transfer of funds; 

19 (2) permits participants, beneficiaries, and en20 rollees to make payments for deductibles or other re21 quired cost sharing through electronic transfer of 

22 funds; and 

23 (3) provides automated, integrated audit con24 trols to monitor any duplicate payments or overpay25 ments within the adjudication system. 
27 

•S 2421 IS 

1 SEC. 113. REGULATIONS. 

2 The Secretary shall issue such regulations as may be 

3 necessary or appropriate to carry out this subtitle. 

4 Subtitle C—Application to Public 

5 Health Service Act and Em6 ployee Retirement Income Secu7 rity Act of 1974 

8 SEC. 121. APPLICATION TO GROUP HEALTH PLANS AND 

9 GROUP HEALTH INSURANCE COVERAGE 

10 UNDER THE PUBLIC HEALTH SERVICE ACT. 

11 (a) IN GENERAL.—Subpart 2 of part A of title 

12 XXVII of the Public Health Service Act is amended by 

13 adding at the end the following new section: 

14 ‘‘SEC. 2707. IMPROVED QUALITY AND REDUCED COSTS. 

15 ‘‘Each group health plan shall comply with the re16 quirements under title I of the Health Care Moderniza17 tion, Cost Reduction, and Quality Improvement Act, and 

18 each health insurance issuer shall comply with health care 

19 modernization requirements under such title with respect 

20 to group health insurance coverage it offers, and such re21 quirements shall be deemed to be incorporated into this 

22 subsection.’’. 

23 (b) CONFORMING AMENDMENT.—Section 

24 2721(b)(2)(A) of such Act (42 U.S.C. 300gg–21(b)(2)(A)) 

25 is amended by inserting ‘‘(other than section 2707)’’ after 

26 ‘‘requirements of such subparts’’. 
28 

•S 2421 IS 

1 SEC. 122. APPLICATION TO INDIVIDUAL HEALTH INSUR2 ANCE COVERAGE UNDER THE PUBLIC 

3 HEALTH SERVICE ACT. 

4 Part B of title XXVII of the Public Health Service 

5 Act is amended by inserting after section 2752 the fol6 lowing new section: 

7 ‘‘SEC. 2753. IMPROVED QUALITY AND REDUCED COSTS. 

8 ‘‘Each health insurance issuer shall comply with re9 quirements under title I of the Health Care Moderniza10 tion, Cost Reduction, and Quality Improvement Act with 

11 respect to individual health insurance coverage it offers, 

12 and such requirements shall be deemed to be incorporated 

13 into this subsection.’’. 

14 SEC. 123. APPLICATION TO GROUP HEALTH PLANS AND 

15 GROUP HEALTH INSURANCE COVERAGE 

16 UNDER THE EMPLOYEE RETIREMENT IN17 COME SECURITY ACT OF 1974. 

18 (a) IN GENERAL.—Subpart B of part 7 of subtitle 

19 B of title I of the Employee Retirement Income Security 

20 Act of 1974 is amended by adding at the end the following 

21 new section: 

22 ‘‘SEC. 714. IMPROVED QUALITY AND REDUCED COSTS. 

23 ‘‘(a) IN GENERAL.—A group health plan (and a 

24 health insurance issuer offering group health insurance 

25 coverage in connection with such a plan) shall comply with 

26 the requirements of title I of the Health Care Moderniza-
29 

•S 2421 IS 

1 tion, Cost Reduction, and Quality Improvement Act (as 

2 in effect as of the date of the enactment of such Act), 

3 and such requirements shall be deemed to be incorporated 

4 into this subsection. 

5 ‘‘(b) PLAN SATISFACTION OF CERTAIN REQUIRE6 MENTS.—For purposes of subsection (a), insofar as a 

7 group health plan provides benefits in the form of health 

8 insurance coverage through a health insurance issuer, the 

9 plan shall be treated as meeting the requirements of title 

10 I of the Health Care Modernization, Cost Reduction, and 

11 Quality Improvement Act with respect to such benefits 

12 and not be considered as failing to meet such requirements 

13 because of a failure of the issuer to meet such require14 ments so long as the plan sponsor or its representatives 

15 did not cause such failure by the issuer. 

16 ‘‘(c) CONFORMING REGULATIONS.—The Secretary 

17 shall issue regulations to coordinate the requirements on 

18 group health plans and health insurance issuers under this 

19 section with the requirements imposed under the other 

20 provisions of this title.’’. 

21 (b) CONFORMING AMENDMENTS.— 

22 (1) IN GENERAL.—Section 732(a) of the Em23 ployee Retirement Income Security Act of 1974 (29 

24 U.S.C. 1185(a)) is amended by striking ‘‘section 

25 711’’ and inserting ‘‘sections 711, 714, and 715’’. 
30 

•S 2421 IS 

1 (2) TABLE OF CONTENTS.—The table of con2 tents in section 1 of the Employee Retirement In3 come Security Act of 1974 is amended by inserting 

4 after the item relating to section 713 the following 

5 new item: 

‘‘Sec. 714. Improved quality and reduced costs.’’. 

6 Subtitle D—Miscellaneous 

7 Provisions 

8 SEC. 131. DEFINITIONS. 

9 In this title: 

10 (1) CLAIM.—The term ‘‘claim’’ means any re11 quest for coverage (including authorization of cov12 erage), for eligibility, or for payment in whole or in 

13 part, for an item or service under a group health 

14 plan or health insurance coverage. 

15 (2) COST SHARING.—The term ‘‘cost-sharing’’ 

16 means any deductibles, coinsurance, copayment 

17 amounts, and liability for balance billing, for which 

18 the participant, beneficiary, or enrollee will be re19 sponsible. 

20 (3) ENROLLEE.—The term ‘‘enrollee’’ means, 

21 with respect to health insurance coverage offered by 

22 a health insurance issuer, an individual enrolled with 

23 the issuer to receive such coverage. 

24 (4) GROUP HEALTH PLAN.—The term ‘‘group 

25 health plan’’ has the meaning given such term in 
31 

•S 2421 IS 

1 section 733(a) of the Employee Retirement Income 

2 Security Act of 1974 (29 U.S.C. 1191b(a)). 

3 (5) HEALTH CARE PROVIDER.—The term 

4 ‘‘health care provider’’ has the meaning given such 

5 term in section 1855(d)(5) of the Social Security 

6 Act. 

7 (6) HEALTH INSURANCE ISSUER.—The term 

8 ‘‘health insurance issuer’’ has the meaning given 

9 such term in section 733(b) of the Employee Retire10 ment Income Security Act of 1974 (29 U.S.C. 

11 1191b(b)). 

12 (7) SECRETARY.—The term ‘‘Secretary’’ means 

13 the Secretary of Health and Human Services. 

14 TITLE II—PAYING FOR 

15 PERFORMANCE 

16 SEC. 201. HEALTH CARE PROVIDER QUALITY STANDARDS. 

17 (a) ESTABLISHMENT.— 

18 (1) IN GENERAL.—Not later than 2 years after 

19 the date of enactment of this Act, the Secretary of 

20 Health and Human Services (referred to in this sec21 tion as the ‘‘Secretary’’) shall establish quality 

22 standards for health care providers to be used as an 

23 element of payment or reimbursement for health 

24 care items or services, including providers providing 
32 

•S 2421 IS 

1 items or services that are paid for by the Federal 

2 Government. 

3 (2) REQUIREMENTS.—Standards under para4 graph (1) shall— 

5 (A) be selected and developed in consulta6 tion with the National Quality Advisory Coun7 cil, other Federal agencies, and the private sec8 tor; 

9 (B) be established in any area where such 

10 a standard is determined by the Secretary to be 

11 feasible and appropriate as a basis for payment 

12 or reimbursement; 

13 (C) be periodically revised and updated; 

14 and 

15 (D) include standards relating to the proc16 ess and outcome of care, as determined feasible 

17 and appropriate by the Secretary. 

18 (3) APPROPRIATENESS.—In determining feasi19 bility and appropriateness under paragraph (2)(B), 

20 the Secretary shall take into account the cost of de21 termining compliance with the standard relative to 

22 the benefit of such standard. 

23 (b) PAYMENTS BASED ON COMPLIANCE WITH

24 STANDARDS.— 

25 (1) IN GENERAL.—Each health care payor— 
33 

•S 2421 IS 

1 (A) shall, except as provided in subsection 

2 (c), provide enhanced payments to health care 

3 providers that achieve or make appropriate 

4 progress toward compliance with the applicable 

5 quality standards developed under subsection 

6 (a); and 

7 (B) may provide for reduced payments to 

8 health care providers that fail to make appro9 priate progress toward, or fail to comply with, 

10 such standards. 

11 (2) FLEXIBILITY.—In determining whether to 

12 provide enhanced or reduced payments under para13 graph (1), the health care payor may provide for a 

14 time-limited period in which— 

15 (A) compliance with the standards are vol16 untary for the health care provider involved; 

17 and 

18 (B) with respect to a health care provider 

19 that has failed to comply with the standards, 

20 the provider may achieve compliance with the 

21 standard in order to gain an enhanced payment 

22 or avoid a reduced payment. 

23 (3) RULE OF CONSTRUCTION.—Nothing in this 

24 subsection shall be construed to— 
34 

•S 2421 IS 

1 (A) prohibit a health care payor from mak2 ing payments to health care providers for their 

3 performance based on standards in addition to 

4 the standards developed under subsection (a); 

5 and 

6 (B) prohibit a health care payor from re7 ducing payments to health care providers who 

8 do not meet the standard, unless specifically 

9 prohibited by the Secretary. 

10 (c) AUTHORITY TO LIMIT TO CERTAIN CATEGORIES

11 OR TYPES OF PROVIDERS.—Each health care payor 

12 may— 

13 (1) limit the requirement for enhanced pay14 ments based on compliance with a standard devel15 oped under subsection (a) to certain categories or 

16 types of health care providers; 

17 (2) establish alternative standards applicable to 

18 the same condition or course of treatment for dif19 ferent types or categories of health care providers; 

20 and 

21 (3) provide for exceptions to the requirements 

22 for enhanced payments based on circumstances in 

23 which payment based on a standard would not serve 

24 the public interest. 
35 

•S 2421 IS 

1 (d) MANDATORY NEGOTIATION OF PAYMENT FOR

2 VALUE.— 

3 (1) IN GENERAL.—If a health care provider de4 termines— 

5 (A) that, notwithstanding the standards 

6 developed under subsection (a), it can provide 

7 health care items or services in a manner that 

8 will reduce cost and improve the quality of care; 

9 and 

10 (B) that providing the items or services de11 scribed in subparagraph (A) will reduce the 

12 amount of reimbursement that would otherwise 

13 be available to the provider; 

14 the provider may request that the payor involved 

15 enter into negotiations to establish an alternative 

16 basis of payment. 

17 (2) GOOD FAITH NEGOTIATION.—A payor that 

18 pays for items or services described in paragraph (1) 

19 shall negotiate an alternative basis of payment for 

20 health care items or services in good faith. Nothing 

21 in the preceding sentence shall be construed to re22 quire any payor to agree to a particular method of 

23 payment or a level of payment that would result in 

24 increased total costs to the payor. 

25 (e) SPECIAL STANDARDS FOR CHRONIC CARE.— 
36 

•S 2421 IS 

1 (1) IN GENERAL.—Standards developed under 

2 subsection (a) for chronic care shall include— 

3 (A) coordination of care; 

4 (B) patient education in self-management; 

5 and 

6 (C) systems for tracking and assuring 

7 achievement of process and outcome objectives. 

8 (2) CONTRACTS.—In carrying out this sub9 section, health care payors shall enter into contracts 

10 with health care providers that are willing to accept 

11 responsibility for the outcome of care for specific in12 dividuals and shall make standards-based payments 

13 to such providers. Such payments shall cover the 

14 costs of services, such as training in patient self15 management and coordination of care, either directly 

16 or through payments to a contracting provider, pur17 suant to standards specified by the Secretary. 

18 (f) HEALTH CARE PAYOR.—In this section, the term 

19 ‘‘health care payor’’ means any entity that pays for, or 

20 reimburses others for payment to, a health care provider 

21 for health care items or services, including a health insur22 ance issuer and the Federal Government. 

23 (g) REPORTING REQUIREMENTS.— 

24 (1) IN GENERAL.—Each health care provider to 

25 which this section applies shall report to the Sec-
37 

•S 2421 IS 

1 retary data on the compliance of the provider with 

2 this section, including data on the quality of health 

3 care provided by such provider and measures to im4 prove the quality of health care provided by such 

5 provider. 

6 (2) PUBLIC AVAILABILITY OF DATA.—The Sec7 retary shall analyze and make publicly available the 

8 data reported to the Secretary under paragraph (1) 

9 in a manner determined to be of value to patients 

10 and health care practitioners. 

11 TITLE III—TARGETED QUALITY 

12 INITIATIVES 

13 SEC. 301. IMPROVING THE QUALITY OF CARE FOR AMERI14 CANS WITH DIABETES. 

15 Title III of the Public Health Service Act (42 U.S.C. 

16 241 et seq.) is amended by adding at the end the fol17 lowing: 

18 ‘‘PART R—IMPROVING THE QUALITY OF CARE 

19 FOR AMERICANS WITH DIABETES 

20 ‘‘SEC. 399A. STATE DIABETES CONTROL AND PREVENTION 

21 PROGRAMS. 

22 ‘‘(a) IN GENERAL.—The Secretary, acting through 

23 the Director of the Centers for Disease Control and Pre24 vention and in consultation with appropriate agencies, 

25 shall support comprehensive diabetes control and preven-
38 

•S 2421 IS 

1 tion programs by awarding grants to eligible entities to 

2 provide public health surveillance, prevention, and control 

3 activities, and to assure affordable, high-quality diabetes 

4 care. 

5 ‘‘(b) ELIGIBILITY.—A State or territory is an eligible 

6 entity under this section. 

7 ‘‘(c) USE OF FUNDS.—Consistent with the com8 prehensive diabetes control and prevention plan submitted 

9 under subsection (d), an eligible entity that receives a 

10 grant under this section may use funds received under 

11 such grant to— 

12 ‘‘(1) conduct health and community research, 

13 including research on behavioral interventions, to 

14 prevent diabetes (including the development of re15 lated complications) and the onset of type 2 diabetes 

16 in persons with pre-diabetes or persons at high risk 

17 for developing diabetes; 

18 ‘‘(2) conduct projects, including community19 based programs of diabetes control and prevention, 

20 and similar collaborations with academic institu21 tions, hospitals, community centers, health insurers, 

22 researchers, health professionals, and nonprofit or23 ganizations; 

24 ‘‘(3) conduct public health surveillance and epi25 demiological activities relating to the prevalence of 
39 

•S 2421 IS 

1 diabetes and assessing disparities in diabetes control 

2 and prevention, including such disparities in under3 served populations; 

4 ‘‘(4) provide public information and education 

5 programs; and 

6 ‘‘(5) provide education and training for health 

7 professionals, including allied health professionals. 

8 ‘‘(d) APPLICATION.—An eligible entity that seeks 

9 funding under this section shall submit an application to 

10 the Secretary at such time, in such manner, and con11 taining such information as the Secretary may require, in12 cluding a comprehensive plan for diabetes-related preven13 tion and control strategies and activities to be undertaken 

14 or supported by the eligible entity, which— 

15 ‘‘(1) is developed with the advice of stake16 holders from the public, private, and nonprofit sec17 tors with expertise relating to diabetes control, pre18 vention, and treatment; 

19 ‘‘(2) is intended to reduce the incidence, mor20 bidity, and mortality of type 1 and 2 diabetes, with 

21 a priority on preventing and controlling diabetes in 

22 at-risk populations and reducing disparities in un23 derserved populations; and 
40 

•S 2421 IS 

1 ‘‘(3) describes the diabetes-related services and 

2 activities to be undertaken or supported by the eligi3 ble entity. 

4 ‘‘SEC. 399A–1. IMPROVING QUALITY OF DIABETES PREVEN5 TION AND CARE. 

6 ‘‘(a) IN GENERAL.—After completion of activities 

7 under subsection (d), the Secretary, acting through the 

8 Director of the Centers for Disease Control and Preven9 tion, and in collaboration with the Director of the Agency 

10 for Healthcare Research and Quality, shall award competi11 tive grants to eligible entities to apply the best practices 

12 identified by the Secretary under subsection (d) for diabe13 tes prevention and control. 

14 ‘‘(b) ELIGIBILITY.—An entity is eligible for a grant 

15 under this section if such entity is— 

16 ‘‘(1) a State, territory, Indian tribe, tribal orga17 nization, public or nonprofit entity; or 

18 ‘‘(2) a partnership of an entity described in 

19 paragraph (1) and an appropriate private sector or20 ganization. 

21 ‘‘(c) PRIORITY.—In awarding grants under this sec22 tion, the Secretary shall give priority to eligible entities 

23 that propose to carry out programs to reduce disparities 

24 in diabetes prevention and control for high-risk or under25 served populations. 
41 

•S 2421 IS 

1 ‘‘(d) BEST PRACTICES.— 

2 ‘‘(1) IN GENERAL.—Not later than 1 year after 

3 the date of enactment of this section, the Secretary 

4 shall identify evidence-based best practices, evidence5 based guidelines and other effective models for dia6 betes prevention and control, which may be adopted 

7 and applied by eligible entities under this section. 

8 ‘‘(2) SPECIFIC BEST PRACTICES.—Best prac9 tices, as described in paragraph (1), may include— 

10 ‘‘(A) State or community-based interven11 tions, school-based screening, care and preven12 tion programs, health systems improvement 

13 strategies, and health and environmental poli14 cies that promote improved nutrition and phys15 ical activity; 

16 ‘‘(B) case management or disease manage17 ment quality improvements programs; 

18 ‘‘(C) appropriate communication, training, 

19 or regional outreach and health promotion ini20 tiatives, including Internet-based initiatives; or 

21 ‘‘(D) models developed or validated by dia22 betes research and training centers established 

23 under section 431. 

24 ‘‘(e) APPLICATION.—An eligible entity that seeks 

25 funding under this section shall prepare and submit to the 
42 

•S 2421 IS 

1 Secretary an application at such time, in such manner, 

2 and containing such information as the Secretary deter3 mines to be necessary, including information regarding 

4 how such entity would use funds received under this sec5 tion to supplement activities carried out under such enti6 ty’s comprehensive diabetes control and prevention plan 

7 under section 399A. 

8 ‘‘(f) AUTHORIZATION OF APPROPRIATIONS.—There 

9 are authorized to be appropriated to carry out this section, 

10 $50,000,000 for fiscal year 2005, and such sums as may 

11 be necessary for each of fiscal years 2006 through 2009. 

12 ‘‘SEC. 399A–2. NATIONAL DIABETES EDUCATION AND OUT13 REACH. 

14 ‘‘(a) PURPOSE.—The Secretary, acting through the 

15 Diabetes Mellitus Interagency Coordinating Committee, 

16 shall coordinate a national diabetes education program to 

17 support, develop, and implement education initiatives and 

18 outreach strategies appropriate for both type 1 and 2 dia19 betes. Such activities may include public awareness cam20 paigns, public service announcements and community 

21 partnership workshops, as well as programs targeted at 

22 businesses and employers, managed care organizations, 

23 and health care providers. 

24 ‘‘(b) PRIORITY.—The Secretary shall emphasize 

25 translation of new scientific and clinical findings into uti-
43 

•S 2421 IS 

1 lizable information for health care providers and patients. 

2 The Secretary shall also give priority to reaching high-risk 

3 or underserved populations. 

4 ‘‘(c) COLLABORATION.—In carrying out this section, 

5 the Secretary shall consult and collaborate with stake6 holders from the public, private, and nonprofit sectors 

7 with expertise relating to diabetes control, prevention, and 

8 treatment. 

9 ‘‘(d) AUTHORIZATION OF APPROPRIATIONS.—There 

10 is authorized to be appropriated to carry out this section, 

11 $15,000,000 for fiscal year 2005 and such sums as may 

12 be necessary for each of fiscal years 2006 through 2009.’’. 

13 ‘‘SEC. 399A–3. DEFINITION. 

14 ‘‘In this part, the term ‘State’ has the meaning given 

15 such term in section 2, and includes Indian tribes.’’. 

16 SEC. 302. IMPROVING THE QUALITY OF CARE FOR AMERI17 CANS WITH ARTHRITIS. 

18 Title III of the Public Health Service Act (42 U.S.C. 

19 241 et seq.), as amended by section 301, is further amend20 ed by adding at the end the following: 
44 

•S 2421 IS 

1 ‘‘PART S—IMPROVING THE QUALITY OF CARE 

2 FOR AMERICANS WITH ARTHRITIS 

3 ‘‘SEC. 399B. STATE ARTHRITIS CONTROL AND PREVENTION 

4 PROGRAMS. 

5 ‘‘(a) IN GENERAL.—The Secretary shall award 

6 grants to eligible entities to provide support for com7 prehensive arthritis control and prevention programs and 

8 to enable such entities to provide public health surveil9 lance, prevention, and control activities related to arthritis 

10 and other rheumatic diseases. 

11 ‘‘(b) ELIGIBILITY.—To be eligible to receive a grant 

12 under this section, an entity shall be a State or Indian 

13 tribe. 

14 ‘‘(c) APPLICATION.—To be eligible to receive a grant 

15 under this section, an entity shall submit to the Secretary 

16 an application at such time, in such manner, and con17 taining such agreements, assurances, and information as 

18 the Secretary may require, including a comprehensive ar19 thritis control and prevention plan that— 

20 ‘‘(1) is developed with the advice of stake21 holders from the public, private, and nonprofit sec22 tors that have expertise relating to arthritis control, 

23 prevention, and treatment that increase the quality 

24 of life and decrease the level of disability; 

25 ‘‘(2) is intended to reduce the morbidity of ar26 thritis, with priority on preventing and controlling 
45 

•S 2421 IS 

1 arthritis in at-risk populations and reducing dispari2 ties in arthritis prevention, diagnosis, management, 

3 and quality of care in underserved populations; 

4 ‘‘(3) describes the arthritis-related services and 

5 activities to be undertaken or supported by the enti6 ty; and 

7 ‘‘(4) is developed in a manner that is consistent 

8 with the National Arthritis Action Plan or a subse9 quent strategic plan designated by the Secretary. 

10 ‘‘(d) USE OF FUNDS.—An eligible entity shall use 

11 amounts received under a grant awarded under subsection 

12 (a) to conduct, in a manner consistent with the com13 prehensive arthritis control and prevention plan submitted 

14 by the entity in the application under subsection (c)— 

15 ‘‘(1) public health surveillance and epidemiolog16 ical activities relating to the prevalence of arthritis 

17 and assessment of disparities in arthritis prevention, 

18 diagnosis, management, and care; 

19 ‘‘(2) public information and education pro20 grams; and 

21 ‘‘(3) education, training, and clinical skills im22 provement activities for health professionals, includ23 ing allied health personnel. 

24 ‘‘(e) AUTHORIZATION OF APPROPRIATIONS.—There 

25 are authorized to be appropriated to carry out this section 
46 

•S 2421 IS 

1 such sums as may be necessary for each of fiscal years 

2 2005 through 2009. 

3 ‘‘SEC. 399B–1. COMPREHENSIVE ARTHRITIS ACTION 

4 GRANTS. 

5 ‘‘(a) IN GENERAL.—The Secretary shall award 

6 grants on a competitive basis to eligible entities to enable 

7 such eligible entities to assist in the implementation of a 

8 national strategy for arthritis control and prevention. 

9 ‘‘(b) ELIGIBILITY.—To be eligible to receive a grant 

10 under this section, an entity shall be a national public or 

11 private nonprofit entity. 

12 ‘‘(c) APPLICATION.—To be eligible to receive a grant 

13 under this section, an entity shall submit to the Secretary 

14 an application at such time, in such manner, and con15 taining such agreements, assurances, and information as 

16 the Secretary may require, including a description of how 

17 funds received under a grant awarded under this section 

18 will— 

19 ‘‘(1) supplement or fulfill unmet needs identi20 fied in the comprehensive arthritis control and pre21 vention plan of a State or Indian tribe; 

22 ‘‘(2) otherwise help achieve the goals of the Na23 tional Arthritis Action Plan or a subsequent stra24 tegic plan designated by the Secretary. 
47 

•S 2421 IS 

1 ‘‘(d) PRIORITY.—In awarding grants under this sec2 tion, the Secretary shall give priority to eligible entities 

3 submitting applications proposing to carry out programs 

4 for controlling and preventing arthritis in at-risk popu5 lations or reducing disparities in underserved populations. 

6 ‘‘(e) USE OF FUNDS.—An eligible entity shall use 

7 amounts received under a grant awarded under subsection 

8 (a) for 1 or more of the following purposes: 

9 ‘‘(1) To expand the availability of physical ac10 tivity programs designed specifically for people with 

11 arthritis. 

12 ‘‘(2) To provide awareness education to pa13 tients, family members, and health care providers, to 

14 help such individuals recognize the signs and symp15 toms of arthritis, and to address the control and 

16 prevention of arthritis. 

17 ‘‘(3) To decrease long-term consequences of ar18 thritis by making information available to individ19 uals with regard to the self-management of arthritis. 

20 ‘‘(4) To provide information on nutrition edu21 cation programs with regard to preventing or miti22 gating the impact of arthritis. 

23 ‘‘(f) EVALUATION.—An eligible entity that receives a 

24 grant under this section shall submit to the Secretary an 

25 evaluation of the operations and activities carried out 
48 

•S 2421 IS 

1 under such grant that includes an analysis of increased 

2 utilization and benefit of public health programs relevant 

3 to the activities described in the appropriate provisions of 

4 subsection (e). 

5 ‘‘(g) AUTHORIZATION OF APPROPRIATIONS.—There 

6 are authorized to be appropriated to carry out this section 

7 such sums as may be necessary for each of fiscal years 

8 2005 through 2009. 

9 ‘‘SEC. 399B–2. NATIONAL ARTHRITIS EDUCATION AND OUT10 REACH. 

11 ‘‘(a) IN GENERAL.—The Secretary shall coordinate 

12 a national education and outreach program to support, de13 velop, and implement education initiatives and outreach 

14 strategies appropriate for arthritis and other rheumatic 

15 diseases. 

16 ‘‘(b) INITIATIVES AND STRATEGIES.—Initiatives and 

17 strategies implemented under the program described in 

18 paragraph (1) may include public awareness campaigns, 

19 public service announcements, and community partnership 

20 workshops, as well as programs targeted at businesses and 

21 employers, managed care organizations, and health care 

22 providers. 

23 ‘‘(c) PRIORITY.—In carrying out subsection (a), the 

24 Secretary— 
49 

•S 2421 IS 

1 ‘‘(1) may emphasize prevention, early diagnosis, 

2 and appropriate management of arthritis, and op3 portunities for effective patient self-management; 

4 and 

5 ‘‘(2) shall give priority to reaching high-risk or 

6 underserved populations. 

7 ‘‘(d) COLLABORATION.—In carrying out this section, 

8 the Secretary shall consult and collaborate with stake9 holders from the public, private, and nonprofit sectors 

10 with expertise relating to arthritis control, prevention, and 

11 treatment. 

12 ‘‘(e) AUTHORIZATION OF APPROPRIATIONS.—There 

13 are authorized to be appropriated to carry out this section 

14 such sums as may be necessary for each of fiscal years 

15 2005 through 2009. 

16 ‘‘SEC. 399B–3. DEFINITION. 

17 ‘‘In this part, the term ‘State’ has the meaning given 

18 such term in section 2, and includes Indian tribes.’’. 

19 SEC. 303. STROKE PREVENTION, TREATMENT, AND REHA20 BILITATION. 

21 Title III of the Public Health Service Act (42 U.S.C. 

22 241 et seq.), as amended by section 302, is further amend23 ed by adding at the end the following: 
50 

•S 2421 IS 

1 ‘‘PART T—STROKE PREVENTION, TREATMENT, 

2 AND REHABILITATION PROGRAMS 

3 ‘‘SEC. 399C. DEFINITIONS. 

4 In this part: 

5 ‘‘(1) STROKE CARE SYSTEM.—The term ‘stroke 

6 care system’ means a statewide system to provide 

7 for the diagnosis, prehospital care, hospital definitive 

8 care, and rehabilitation of stroke patients. 

9 ‘‘(2) STROKE.—The term ‘stroke’ means a 

10 ‘brain attack’ in which blood flow to the brain is in11 terrupted or in which a blood vessel or aneurysm in 

12 the brain breaks or ruptures. 

13 ‘‘SEC. 399C–1. GRANTS TO STATES FOR STROKE CARE SYS14 TEMS. 

15 ‘‘(a) GRANTS.—The Secretary shall award grants to 

16 States for the development and implementation of stroke 

17 care systems that provide high-quality prevention, diag18 nosis, treatment, and rehabilitation. 

19 ‘‘(b) REQUIRED USES.— 

20 ‘‘(1) IN GENERAL.—In carrying out activities 

21 described in subsection (a), each State that is 

22 awarded a grant under this section shall— 

23 ‘‘(A) establish, enhance, or expand a state24 wide stroke care system for the purpose of en25 suring access to high-quality stroke prevention, 

26 diagnosis, treatment, and rehabilitation, except 
51 

•S 2421 IS 

1 that activities conducted under this subpara2 graph shall be consistent with guidelines or rec3 ommendations issued by the Secretary under 

4 section 399C–3(a)(2) to the extent that such 

5 guidelines or recommendations have been 

6 issued; 

7 ‘‘(B) establish, enhance, or expand, as ap8 propriate, stroke care centers, except that ac9 tivities conducted under this subparagraph shall 

10 be consistent with guidelines or recommenda11 tions issued by the Secretary under section 

12 399C–3(a)(2), to the extent that such guide13 lines or recommendations have been issued; 

14 ‘‘(C) conduct evaluation activities to mon15 itor clinical outcomes and procedures and to 

16 verify resources, infrastructure, and operations 

17 devoted to stroke care; 

18 ‘‘(D) enhance, develop, and implement a 

19 model curriculum for training emergency med20 ical services personnel in the identification, as21 sessment, stabilization, and prehospital treat22 ment of stroke patients, which curriculum may, 

23 at the discretion of the State, consist of or be 

24 based on the model curriculum developed by the 

25 Secretary under section 399C–3(a)(1); 
52 

•S 2421 IS 

1 ‘‘(E) enhance coordination of emergency 

2 medical services with respect to stroke care; 

3 ‘‘(F) establish, enhance, or improve a cen4 tral data reporting and analysis system de5 scribed in subsection (c); 

6 ‘‘(G) establish, enhance, or improve a sup7 port network described in subsection (d) to pro8 vide assistance to facilities with smaller popu9 lations of stroke patients or less advanced on10 site stroke treatment resources; 

11 ‘‘(H) consult with organizations and indi12 viduals with expertise in stroke prevention, di13 agnosis, treatment, and rehabilitation; and 

14 ‘‘(I) with respect to carrying out subpara15 graph (C) through (H), use the best available 

16 evidence and consensus recommendations of 

17 professional associations. 

18 ‘‘(2) PERMISSIBLE USES.—In developing and 

19 implementing a stroke care system described in 

20 paragraph (1), each State that is awarded a grant 

21 under this section may— 

22 ‘‘(A) improve existing State stroke preven23 tion programs; and 

24 ‘‘(B) conduct a stroke education and infor25 mation campaign, including by— 
53 

•S 2421 IS 

1 ‘‘(i) making public service announce2 ments about the warning signs of stroke 

3 and the importance of treating stroke as a 

4 medical emergency; and 

5 ‘‘(ii) providing education regarding 

6 ways to prevent stroke and the effective7 ness of stroke treatment. 

8 ‘‘(c) CENTRAL DATA REPORTING AND ANALYSIS

9 SYSTEM.—A central data reporting and analysis system 

10 described in this section is a system that collects data from 

11 facilities that provide direct care to stroke patients and 

12 uses the data— 

13 ‘‘(1) to identify the number of stroke patients 

14 treated in the State; 

15 ‘‘(2) to monitor patient care in the State for 

16 stroke patients at all phases of stroke for the pur17 pose of evaluating the diagnosis, treatment, and 

18 treatment outcome of such stroke patients; 

19 ‘‘(3) to identify the total amount of uncompen20 sated and under-compensated stroke care expendi21 tures for each fiscal year by each stroke care facility 

22 in the State; 

23 ‘‘(4) to identify the number of acute stroke pa24 tients who receive advanced drug therapy; and 
54 

•S 2421 IS 

1 ‘‘(5) to identify patients transferred within the 

2 statewide stroke care system, including reasons for 

3 such transfer. 

4 ‘‘(d) SUPPORT NETWORK.—A support network de5 scribed in this section may include the following: 

6 ‘‘(1) The use of telehealth technology to connect 

7 facilities described in subsection (b)(1)(G) to more 

8 advanced stroke care facilities. 

9 ‘‘(2) The provision of neuroimaging, laboratory, 

10 and any other equipment necessary to facilitate the 

11 establishment of a telehealth network. 

12 ‘‘(3) The use of phone consultation, where use13 ful. 

14 ‘‘(4) The use of referral links when a patient 

15 needs more advanced care than is available at the 

16 facility providing initial care. 

17 ‘‘(5) The provision of any other assistance de18 termined appropriate by the State. 

19 ‘‘(e) RESTRICTIONS ON USE OF PAYMENTS.—The 

20 Secretary may not make payments to a State under this 

21 section for a fiscal year unless the State agrees that the 

22 payments will not be expended— 

23 ‘‘(1) to make cash payments to intended recipi24 ents of services provided pursuant to this section; 
55 

•S 2421 IS 

1 ‘‘(2) to satisfy any requirement for the expendi2 ture of non-Federal funds as a condition for the re3 ceipt of Federal funds; 

4 ‘‘(3) to provide financial assistance to any enti5 ty other than a public or nonprofit private entity; or 

6 ‘‘(4) for construction, alteration, or improve7 ment of any building or facility. 

8 ‘‘(f) FAILURE TO COMPLY WITH AGREEMENTS.— 

9 ‘‘(1) REPAYMENT OF PAYMENTS.— 

10 ‘‘(A) REQUIREMENT.—The Secretary may, 

11 in accordance with paragraph (2), require a 

12 State to repay any payments received by the 

13 State under this section that the Secretary de14 termines were not expended by the State in ac15 cordance with the agreements required to be 

16 made by the State as a condition of the receipt 

17 of the payments. 

18 ‘‘(B) OFFSET OF AMOUNTS.—If a State 

19 fails to make a repayment required in subpara20 graph (A), the Secretary may offset the amount 

21 of the repayment against any amount due to be 

22 paid to the State under this section. 

23 ‘‘(2) OPPORTUNITY FOR A HEARING.—Before 

24 requiring repayment of payments under paragraph 
56 

•S 2421 IS 

1 (1), the Secretary shall provide to the State an op2 portunity for a hearing. 

3 ‘‘(g) APPLICATION REQUIREMENTS.—The Secretary 

4 may not award a grant to a State under this section un5 less— 

6 ‘‘(1) the State submits an application con7 taining agreements in accordance with this section; 

8 ‘‘(2) the agreements are made through certifi9 cation from the chief executive officer of the State; 

10 ‘‘(3) with respect to such agreements, the appli11 cation provides assurances of compliance satisfactory 

12 to the Secretary; 

13 ‘‘(4) the application contains the plan provi14 sions and the information required to be submitted 

15 to the Secretary; and 

16 ‘‘(5) the application otherwise is in such form, 

17 is made in such manner, and contains such agree18 ments, assurances, and information as the Secretary 

19 determines to be necessary to carry out this section. 

20 ‘‘(h) TECHNICAL ASSISTANCE.—The Secretary shall, 

21 without charge to a State receiving payments under this 

22 section, provide to the State (or to any public or nonprofit 

23 entity designated by the State) technical assistance with 

24 respect to the planning, development, and operation of any 

25 program carried out pursuant to this section. The Sec-
57 

•S 2421 IS 

1 retary may provide such technical assistance directly, 

2 through contracts, or through grants. 

3 ‘‘(i) SUPPLIES AND SERVICES IN LIEU OF GRANT

4 FUNDS.— 

5 ‘‘(1) IN GENERAL.—Upon the request of a 

6 State receiving payments under this section, the Sec7 retary may, subject to paragraph (2), provide sup8 plies, equipment, and services to the State and may 

9 detail to the State any officer or employee of the De10 partment of Health and Human Services, for the 

11 purpose of assisting the State to achieve the purpose 

12 of the payments. 

13 ‘‘(2) REDUCTION IN PAYMENTS.—With respect 

14 to a request described in paragraph (1), the Sec15 retary shall reduce the amount of payments to the 

16 State under this section by an amount equal to the 

17 costs of detailing personnel and the fair market 

18 value of any supplies, equipment, or services provided 

19 by the Secretary. The Secretary shall, for the pay20 ment of expenses incurred in complying with such re21 quest, expend the amounts withheld. 

22 ‘‘(j) LIMITATION ON ADMINISTRATIVE EXPENSES.— 

23 The Secretary may not award a grant to a State under 

24 this section unless the State agrees to use not more than 
58 

•S 2421 IS 

1 10 percent of amounts received under the grant for admin2 istrative expenses. 

3 ‘‘(k) AUTHORIZATION OF APPROPRIATIONS.—There 

4 is authorized to be appropriated to carry out this section, 

5 such sums as may be necessary for each of fiscal years 

6 2005 through 2009. 

7 ‘‘SEC. 399C–2. PLANNING GRANTS. 

8 ‘‘(a) GRANTS.—The Secretary may award a grant to 

9 a State to assist such State in formulating a plan to de10 velop a stroke care system in accordance with section 

11 399C–1 or in otherwise meeting the requirements of such 

12 section. 

13 ‘‘(b) SUBMISSION TO SECRETARY.—The chief execu14 tive officer of a State that receives a grant under this sec15 tion shall submit to the Secretary a copy of the plan devel16 oped using the amounts provided under such grant. Such 

17 plan shall be submitted to the Secretary as soon as prac18 ticable after the plan has been developed. 

19 ‘‘(c) SINGLE GRANT LIMITATION.—A State is not eli20 gible to receive a grant under this section if the State pre21 viously received a grant under this section. 

22 ‘‘(d) AUTHORIZATION OF APPROPRIATIONS.—There 

23 is authorized to be appropriated to carry out this section, 

24 such sums as may be necessary for each of fiscal years 

25 2005 through 2009. 
59 

•S 2421 IS 

1 ‘‘SEC. 399C–3. RESPONSIBILITIES OF THE SECRETARY. 

2 ‘‘(a) IN GENERAL.—The Secretary shall, with respect 

3 to stroke care— 

4 ‘‘(1) develop a model curriculum for training 

5 emergency medical services personnel, including dis6 patchers, first responders, emergency medical techni7 cians, and paramedics, in the identification, assess8 ment, stabilization, and prehospital treatment of 

9 stroke patients; and 

10 ‘‘(2) issue recommendations or guidelines on 

11 best practices for the establishment and operation of 

12 statewide stroke care systems, including rec13 ommendations or guidelines on best practices for the 

14 establishment and operation of stroke care centers. 

15 ‘‘(b) GRANTS, COOPERATIVE AGREEMENTS, AND

16 CONTRACTS.—The Secretary may make grants, and enter 

17 into cooperative agreements and contracts, for the purpose 

18 of carrying out subsection (a). 

19 ‘‘(c) RULES OF CONSTRUCTION.— 

20 ‘‘(1) EXISTING GUIDELINES.—Nothing in sub21 section (a)(2) shall be construed to require the Sec22 retary to issue new recommendations or guidelines 

23 where existing recommendations or guidelines issued 

24 or adopted by the Secretary are applicable to the es25 tablishment of statewide stroke systems. Where an 

26 existing recommendation or guideline is applicable to 
60 

•S 2421 IS 

1 the establishment of statewide stroke systems, the 

2 Secretary may deem such recommendation or guide3 line to have been issued under subsection (a)(2). 

4 ‘‘(2) ADVISORY NATURE OF GUIDELINES.—Rec5 ommendations or guidelines issued under subsection 

6 (a)(2) shall be considered advisory in nature and 

7 shall not be construed to constitute a standard of 

8 care for the treatment of stroke.’’. 

9 SEC. 304. INCREASING LANGUAGE ACCESS FOR AMERICANS 

10 WITH LIMITED ENGLISH PROFICIENCY. 

11 Title II of the Public Health Service Act (42 U.S.C. 

12 202 et seq.) is amended by adding at the end thereof the 

13 following: 

14 ‘‘PART C—INCREASING LANGUAGE ACCESS FOR 

15 AMERICANS WITH LIMITED ENGLISH PRO16 FICIENCY 

17 ‘‘SEC. 251. IMPROVING ACCESS TO SERVICES FOR INDIVID18 UALS WITH LIMITED ENGLISH PROFICIENCY. 

19 ‘‘(a) PURPOSE.—As provided in Executive Order 

20 13166, it is the purpose of this section— 

21 ‘‘(1) to improve access to Federally conducted 

22 and Federally assisted programs and activities for 

23 individuals who are limited in their English pro24 ficiency; 
61 

•S 2421 IS 

1 ‘‘(2) to require each Federal agency to examine 

2 the services it provides and develop and implement 

3 a system by which limited English proficient individ4 uals can enjoy meaningful access to those services 

5 consistent with, and without substantially burdening, 

6 the fundamental mission of the agency; 

7 ‘‘(3) to require each Federal agency to ensure 

8 that recipients of Federal financial assistance pro9 vide meaningful access to their limited English pro10 ficient applicants and beneficiaries; 

11 ‘‘(4) to ensure that recipients of Federal finan12 cial assistance take reasonable steps, consistent with 

13 the guidelines set forth in the Limited English Pro14 ficient Guidance of the Department of Justice (as 

15 issued on June 12, 2002), to ensure meaningful ac16 cess to their programs and activities by limited 

17 English proficient individuals; and 

18 ‘‘(5) to ensure compliance with title VI of the 

19 Civil Rights Act of 1964 and that health care pro20 viders and organizations do not discriminate in the 

21 provision of services. 

22 ‘‘(b) FEDERALLY CONDUCTED PROGRAMS AND AC23 TIVITIES.— 

24 ‘‘(1) IN GENERAL.—Not later than 120 days 

25 after the date of enactment of this Act, each Federal 
62 

•S 2421 IS 

1 agency that carries out health care-related activities 

2 shall prepare a plan to improve access to the feder3 ally conducted health care-related programs and ac4 tivities of the agency by limited English proficient 

5 individuals. 

6 ‘‘(2) PLAN REQUIREMENT.—Each plan under 

7 paragraph (1) shall provide for, at a minimum, the 

8 factors and principles set forth in the Department of 

9 Justice guidance published on June 12, 2002, and 

10 shall include the steps the agency will take to ensure 

11 that limited English proficient individuals have ac12 cess to the agency’s health care-related programs 

13 and activities. Each agency shall send a copy of such 

14 plan to the Department of Justice, which shall serve 

15 as the central repository of the agencies’ plans. 

16 ‘‘(c) FEDERALLY ASSISTED PROGRAMS AND ACTIVI17 TIES.— 

18 ‘‘(1) IN GENERAL.—Not later than 120 days 

19 after the date of enactment of this Act, each Federal 

20 agency providing health care-related Federal finan21 cial assistance shall ensure that the guidance for re22 cipients of Federal financial assistance developed by 

23 the agency to ensure compliance with title VI of the 

24 Civil Rights Act of 1964 (42 U.S.C. 2000d et seq.) 

25 is specifically tailored to the recipients of such as-
63 

•S 2421 IS 

1 sistance and provides for, at a minimum, the factors 

2 and principles set forth in the Department of Justice 

3 guidance published on June 12, 2002. Each agency 

4 shall send a copy of such guidance to the Depart5 ment of Justice which shall serve as the central re6 pository of the agencies’ plans. After approval by the 

7 Department of Justice, each agency shall publish its 

8 guidance document in the Federal Register for pub9 lic comment. 

10 ‘‘(2) REQUIREMENTS.—The agency-specific 

11 guidance developed under paragraph (1) shall— 

12 ‘‘(A) detail how the general standards will 

13 be applied to the agency’s recipients; and 

14 ‘‘(B) take into account the types of health 

15 care services provided by the recipients, the in16 dividuals served by the recipients, and other 

17 factors set out in such standards. 

18 ‘‘(3) EXISTING GUIDANCES.—A Federal agency 

19 that has developed a guidance for purposes of title 

20 VI of the Civil Rights Act of 1964 that the Depart21 ment of Justice determines provides for, at a min22 imum, the factors and principles set forth in the De23 partment of Justice guidance published on June 12, 

24 2002, shall examine such existing guidance, as well 

25 as the programs and activities to which such guid-
64 

•S 2421 IS 

1 ance applies, to determine if modification of such 

2 guidance is necessary to comply with this subsection. 

3 ‘‘(4) CONSULTATION.—Each Federal agency 

4 shall consult with the Department of Justice in es5 tablishing the guidances under this subsection. 

6 ‘‘(d) CONSULTATIONS.— 

7 ‘‘(1) IN GENERAL.—In carrying out this sec8 tion, each Federal agency that carriers out health 

9 care-related activities shall ensure that stakeholders, 

10 such as limited English proficient individuals and 

11 their representative organizations, recipients of Fed12 eral assistance, and other appropriate individuals or 

13 entities, have an adequate and comparable oppor14 tunity to provide input with respect to the actions of 

15 the agency. 

16 ‘‘(2) EVALUATION OF NEEDS.—Each Federal 

17 agency described in paragraph (1) shall evaluate the 

18 particular needs of the limited English proficient in19 dividuals served by the agency, and by a recipient of 

20 assistance provided by the agency, and the burdens 

21 of compliance with the agency guidance and its re22 cipients of the requirements of this section. 
65 

•S 2421 IS 

1 ‘‘SEC. 252. NATIONAL STANDARDS FOR CULTURALLY AND 

2 LINGUISTICALLY APPROPRIATE SERVICES IN 

3 HEALTHCARE. 

4 ‘‘Recipients of Federal financial assistance from the 

5 Secretary shall, to the extent reasonable and practicable 

6 after applying the 4-factor analysis described in title V 

7 of the Guidance to Federal Financial Assistance Recipi8 ents Regarding Title VI Prohibition Against National Ori9 gin Discrimination Affecting Limited-English Proficient 

10 Persons (June 12, 2002)— 

11 ‘‘(1) implement strategies to recruit, retain, and 

12 promote individuals at all levels of the organization 

13 to maintain a diverse staff and leadership that can 

14 provide culturally and linguistically appropriate 

15 healthcare to patient populations of the service area 

16 of the organization; 

17 ‘‘(2) ensure that staff at all levels and across all 

18 disciplines of the organization receive ongoing edu19 cation and training in culturally and linguistically 

20 appropriate service delivery; 

21 ‘‘(3) offer and provide language assistance serv22 ices, including bilingual staff and interpreter serv23 ices, at no cost to each patient with limited English 

24 proficiency at all points of contact, in a timely man25 ner during all hours of operation; 
66 

•S 2421 IS 

1 ‘‘(4) notify patients of their right to receive lan2 guage assistance services in their primary language; 

3 ‘‘(5) ensure the competence of language assist4 ance provided to limited English proficient patients 

5 by interpreters and bilingual staff, and ensure that 

6 family and friends are not used to provide interpre7 tation services— 

8 ‘‘(A) except in case of emergency; or 

9 ‘‘(B) except on request of the patient, who 

10 has been informed in his or her preferred lan11 guage of the availability of free interpretation 

12 services; 

13 ‘‘(6) make available easily understood patient14 related materials including information or notices 

15 about termination of benefits and post signage in 

16 the languages of the commonly encountered groups 

17 or groups represented in the service area of the or18 ganization; 

19 ‘‘(7) develop and implement clear goals, poli20 cies, operational plans, and management account21 ability and oversight mechanisms to provide cul22 turally and linguistically appropriate services; 

23 ‘‘(8) conduct initial and ongoing organizational 

24 self-assessments of culturally and linguistically ap25 propriate services-related activities and integrate cul-
67 

•S 2421 IS 

1 tural and linguistic competence-related measures 

2 into the internal audits, performance improvement 

3 programs, patient satisfaction assessments, and out4 comes-based evaluations of the organization; 

5 ‘‘(9) ensure that, consistent with the privacy 

6 protections provided for under the regulations pro7 mulgated under section 264(c) of the Health Insur8 ance Portability and Accountability Act of 1996 (42 

9 U.S.C. 1320d–2 note)— 

10 ‘‘(A) data on the individual patient’s race, 

11 ethnicity, and primary language are collected in 

12 health records, integrated into the organiza13 tion’s management information systems, and 

14 periodically updated; and 

15 ‘‘(B) if the patient is a minor or is inca16 pacitated, the primary language of the parent 

17 or legal guardian is collected; 

18 ‘‘(10) maintain a current demographic, cultural, 

19 and epidemiological profile of the community as well 

20 as a needs assessment to accurately plan for and im21 plement services that respond to the cultural and 

22 linguistic characteristics of the service area of the 

23 organization; 

24 ‘‘(11) develop participatory, collaborative part25 nerships with communities and utilize a variety of 
68 

•S 2421 IS 

1 formal and informal mechanisms to facilitate com2 munity and patient involvement in designing and im3 plementing culturally and linguistically appropriate 

4 services-related activities; 

5 ‘‘(12) ensure that conflict and grievance resolu6 tion processes are culturally and linguistically sen7 sitive and capable of identifying, preventing, and re8 solving cross-cultural conflicts or complaints by pa9 tients; 

10 ‘‘(13) regularly make available to the public in11 formation about their progress and successful inno12 vations in implementing the standards under this 

13 section and provide public notice in their commu14 nities about the availability of this information; and 

15 ‘‘(14) regularly make available to the head of 

16 each Federal entity from which Federal funds are 

17 received, information about their progress and suc18 cessful innovations in implementing the standards 

19 under this section as required by the head of such 

20 entity. 

21 ‘‘SEC. 253. INNOVATIONS IN LANGUAGE ACCESS GRANTS. 

22 ‘‘(a) IN GENERAL.—The Secretary, acting through 

23 the Administrator of the Centers for Medicare and Med24 icaid Services, the Administrator of the Health Resources 

25 and Services Administration, and the Director of the Of-
69 

•S 2421 IS 

1 fice of Minority Health, shall award grants to eligible enti2 ties to enable such entities to design, implement, and 

3 evaluate innovative, cost-effective programs to improve lin4 guistic access to health care for individuals with limited 

5 English proficiency. 

6 ‘‘(b) ELIGIBILITY.—To be eligible to receive a grant 

7 under subsection (a) an entity shall— 

8 ‘‘(1) be a city, county, Indian tribe, State, terri9 tory, community-based nonprofit organization, 

10 health center or community clinic, university, col11 lege, or other entity designated by the Secretary; 

12 and 

13 ‘‘(2) prepare and submit to the Secretary an 

14 application, at such time, in such manner, and ac15 companied by such additional information as the 

16 Secretary may require. 

17 ‘‘(c) USE OF FUNDS.—An entity shall use funds re18 ceived under a grant under this section to— 

19 ‘‘(1) develop, implement, and evaluate models of 

20 providing real-time interpretation services through 

21 in-person interpretation, communications, and com22 puter technology, including the Internet, teleconfer23 encing, or video conferencing; 

24 ‘‘(2) develop short-term medical interpretation 

25 training courses and incentives for bilingual health 
70 

•S 2421 IS 

1 care staff who are asked to interpret in the work2 place; 

3 ‘‘(3) develop formal training programs for indi4 viduals interested in becoming dedicated health care 

5 interpreters; 

6 ‘‘(4) provide language training courses for 

7 health care staff; 

8 ‘‘(5) provide basic health care-related English 

9 language instruction for limited English proficient 

10 individuals; or 

11 ‘‘(6) develop other language assistance services 

12 as determined appropriate by the Secretary. 

13 ‘‘(d) PRIORITY.—In awarding grants under this sec14 tion, the Secretary shall give priority to entities that have 

15 developed partnerships with organizations or agencies with 

16 experience in language access services. 

17 ‘‘(e) EVALUATION.—An entity that receives a grant 

18 under this section shall submit to the Secretary an evalua19 tion that describes the activities carried out with funds 

20 received under the grant, and how such activities improved 

21 access to health care services and the quality of health 

22 care for individuals with limited English proficiency. Such 

23 evaluation shall be collected and disseminated through the 

24 Center for Linguistic and Cultural Competence in 

25 Healthcare. 
71 

•S 2421 IS 

1 ‘‘(f) GRANTEE CONVENTION.—The Secretary, acting 

2 through the Director of the Center for Linguistic and Cul3 tural Competence in Healthcare, shall at the end of the 

4 grant cycle convene grantees under this section to share 

5 findings and develop and disseminate model programs and 

6 practices. 

7 ‘‘(g) AUTHORIZATION OF APPROPRIATIONS.—There 

8 is authorized to be appropriated to carry out this section, 

9 such sums as may be necessary for each of fiscal years 

10 2005 through 2010. 

11 ‘‘SEC. 254. STANDARDS FOR LANGUAGE ACCESS SERVICES. 

12 ‘‘Not later than 120 days after the date of enactment 

13 of this subtitle, the head of each Federal agency that car14 ries out health care-related activities shall develop and 

15 adopt a guidance on language services for those with lim16 ited English proficiency who attempt to have access to or 

17 participate in such activities that provides at the minimum 

18 the factors and principles set forth in the Department of 

19 Justice guidance published on June 12, 2002. 

20 ‘‘SEC. 255. REPORT ON FEDERAL EFFORTS TO PROVIDE 

21 CULTURALLY AND LINGUISTICALLY APPRO22 PRIATE HEALTH CARE SERVICES. 

23 ‘‘Not later than 1 year after the date of enactment 

24 of this subtitle and annually thereafter, the Secretary shall 

25 enter into a contract with the Institute of Medicine for 
72 

•S 2421 IS 

1 the preparation and publication of a report that describes 

2 federal efforts to ensure that all individuals have meaning3 ful access to culturally and linguistically appropriate 

4 health care services. Such report shall include— 

5 ‘‘(1) a description and evaluation of the activi6 ties carried out under this part; and 

7 ‘‘(2) a description of best practices, model pro8 grams, guidelines, and other effective strategies for 

9 providing access to culturally and linguistically ap10 propriate health care services.’’. 

11 SEC. 305. FEDERAL REIMBURSEMENT FOR CULTURALLY 

12 AND LINGUISTICALLY APPROPRIATE SERV13 ICES. 

14 (a) MEDICARE.—Title XVIII of the Social Security 

15 Act (42 U.S.C. 1395 et seq.) is amended by adding at 

16 the end the following: 

17 ‘‘MEDICARE PAYMENT FOR CULTURALLY AND

18 LINGUISTICALLY APPROPRIATE SERVICES

19 ‘‘SEC. 1898. (a) PAYMENT FOR CULTURALLY AND

20 LINGUISTICALLY APPROPRIATE SERVICES.—Notwith21 standing any other provision of this title, by not later than 

22 January 1, 2006, the Secretary shall provide several alter23 native additions to the payment amounts for items and 

24 services for which payment may be made under the pay25 ment systems described in subsection (d) for items and 

26 services furnished to a LEP beneficiary (as defined by the 
73 

•S 2421 IS 

1 Secretary) for the estimated cost of providing quality cul2 turally and linguistically appropriate language services 

3 (including in-person and telephonic interpreter services 

4 and written translation services. 

5 ‘‘(b) APPLICATION TO SPECIFIC PROVIDERS.—The 

6 Secretary shall apply the addition described in subsection 

7 (a) to each specific individual or entity paid under a pay8 ment system described in subsection (d) that reflects the 

9 cost of most efficiently providing such quality services by 

10 that individual or entity. 

11 ‘‘(c) CONSIDERATIONS IN DEVELOPING ALTER12 NATIVE AMOUNTS.—In developing the alternative 

13 amounts described in subsection (a), the Secretary shall— 

14 ‘‘(1) consider which types of language access 

15 services are most appropriate for the improvement of 

16 the quality of care of LEP beneficiaries (as so de17 fined), and ensure that interpretation is one of these 

18 services; 

19 ‘‘(2) consider what those services should include 

20 and such other factors as the Secretary determines 

21 to be appropriate; 

22 ‘‘(3) consider the cost to a hospital of con23 tracting for such services, the cost of providing such 

24 services internally, the cost of providing such serv25 ices through electronic and telecommunications 
74 

•S 2421 IS 

1 means, the extra cost of ensuring such services are 

2 available with respect to languages not frequently 

3 used in the United States, and the extra cost of en4 suring such services are available in rural areas; 

5 ‘‘(4) ensure the adequate adjustment of such 

6 additions for annual changes in the cost of providing 

7 such services. 

8 ‘‘(d) PAYMENT SYSTEMS DESCRIBED.—The payment 

9 systems described in this subsection are the payments sys10 tems under this title, including the following: 

11 ‘‘(1) INPATIENT HOSPITAL SERVICES.—The 

12 prospective payment system for inpatient hospital 

13 services under section 1886(d). 

14 ‘‘(2) HOSPITAL OUTPATIENT DEPARTMENT

15 SERVICES.—The prospective payment system for 

16 hospital outpatient department services under sec17 tion 1833(t). 

18 ‘‘(3) PSYCHIATRIC HOSPITALS.—The payment 

19 system applicable with respect to psychiatric hos20 pitals (as defined in section 1861(f)). 

21 ‘‘(4) REHABILITATION FACILITIES.—The pro22 spective payment system for rehabilitation facilities 

23 under section 1886(j). 

24 ‘‘(5) CHILDREN’S, LONG-TERM CARE, AND CAN25 CER HOSPITALS.—The payment systems applicable 
75 

•S 2421 IS 

1 with respect to hospitals described in clause (iii), 

2 (iv), or (v) of section 1886(d)(1)(B). 

3 ‘‘(6) SKILLED NURSING FACILITIES.—The pro4 spective payment system for skilled nursing facility 

5 services under section 1888(e). 

6 ‘‘(7) HOME HEALTH SERVICES.—The prospec7 tive payment system for home health services under 

8 section 1895. 

9 ‘‘(8) RENAL DIALYSIS FACILITIES.—The pay10 ment system for services provided to end-stage renal 

11 disease patients under section 1881. 

12 ‘‘(9) PHYSICIANS’ FEE SCHEDULE.—The physi13 cians’ fee schedule under section 1848. 

14 ‘‘(10) MEDICARE ADVANTAGE PROGRAM.—The 

15 Medicare Advantage program under part C. 

16 ‘‘(11) VOLUNTARY PRESCRIPTION DRUG BEN17 EFIT PROGRAM.—The voluntary prescription drug 

18 benefit program under part D.’’. 

19 (b) MEDICAID.—Section 1903(a)(3) of the Social Se20 curity Act (42 U.S.C. 1396b(a)(3)) is amended— 

21 (1) in subparagraph (D), by striking ‘‘plus’’ at 

22 the end and inserting ‘‘and’’; and 

23 (2) by adding at the end the following: 

24 ‘‘(E) 90 percent of the sums expended with 

25 respect to costs incurred during such quarter as 
76 

•S 2421 IS 

1 are attributable to the provision of culturally 

2 and linguistically appropriate services, including 

3 oral interpretation, translations of written ma4 terials, and other cultural and linguistic services 

5 for individuals with limited English proficiency 

6 and disabilities who apply for, or receive, med7 ical assistance under the State plan (including 

8 any waiver granted to the State plan); plus’’. 

9 (c) SCHIP.—Section 2105(a)(1) of the Social Secu10 rity Act (42 U.S.C.1397ee(a)), as amended by section 

11 515, is amended— 

12 (1) in the matter preceding subparagraph (A), 

13 by inserting ‘‘or, in the case of expenditures de14 scribed in subparagraph (D)(iv), 90 percent’’ after 

15 ‘‘enhanced FMAP’’; and 

16 (2) in subparagraph (D)— 

17 (A) in clause (iii), by striking ‘‘and’’ at the 

18 end; 

19 (B) by redesignating clause (iv) as clause 

20 (v); and 

21 (C) by inserting after clause (iii) the fol22 lowing: 

23 ‘‘(iv) for expenditures attributable to 

24 the provision of culturally and linguistically 

25 appropriate services, including oral inter-
77 

•S 2421 IS 

1 pretation, translations of written materials, 

2 and other language services for individuals 

3 with limited English proficiency and dis4 abilities who apply for, or receive, child 

5 health assistance under the plan; and’’. 

6 (d) EFFECTIVE DATE.—The amendments made by 

7 this section take effect on October 1, 2005. 

8 SEC. 306. NATIONAL QUALITY ADVISORY COUNCIL. 

9 (a) ESTABLISHMENT.—There is hereby established 

10 the National Quality Advisory Council (in this section re11 ferred to as the ‘‘Council’’). 

12 (b) MEMBERS.— 

13 (1) NUMBER AND APPOINTMENT.—The Council 

14 shall be composed of 15 members to be appointed by 

15 the Comptroller General in accordance with this sub16 section. 

17 (2) QUALIFICATION.— 

18 (A) IN GENERAL.—The members of the 

19 Council shall include individuals with national 

20 recognition for their expertise in health care 

21 quality, quality measurement systems, con22 sumer reporting, health care management, 

23 health plans and integrated delivery systems, 

24 health care financing, minority (and other vul25 nerable populations) health, and other related 
78 

•S 2421 IS 

1 fields who provide a mix of different professions 

2 and broad geographic and culturally diverse 

3 representation. 

4 (B) INCLUSION.—The members of the 

5 Council shall include physicians and other 

6 health professionals, employers, third-party pay7 ers, individuals skilled in the conduct and inter8 pretation of biomedical health services and 

9 health quality research and with expertise in 

10 outcomes and effectiveness research and tech11 nology assessment, and representatives of con12 sumers from diverse backgrounds. 

13 (C) MAJORITY NONPROVIDERS.—Individ14 uals who are directly involved in the provision, 

15 or management of the delivery, of items and 

16 services covered under this title shall not con17 stitute a majority of the members of the Coun18 cil. 

19 (D) ETHICAL DISCLOSURE.—The Comp20 troller General shall establish a system for the 

21 public disclosure, by members of the Council, of 

22 financial and other potential conflicts of interest 

23 relating to such members. 

24 (3) TERMS.— 
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•S 2421 IS 

1 (A) IN GENERAL.—The terms of the mem2 bers of the Council shall be for 5 years except 

3 that the Comptroller General shall stagger the 

4 terms of the members first appointed. 

5 (B) VACANCIES.—Any member appointed 

6 to fill a vacancy occurring in the Council before 

7 the expiration of the term for which the mem8 ber’s predecessor was appointed shall be ap9 pointed only for the remainder of that term. A 

10 member may serve after the expiration of that 

11 member’s term until a successor has been ap12 pointed. A vacancy in the membership of the 

13 Commission shall be filled in the manner in 

14 which the original appointment was made. 

15 (4) COMPENSATION.—While carrying out the 

16 business of the Council (including travel time), a 

17 member of the Council shall be entitled to compensa18 tion at the per diem equivalent rate provided for 

19 level IV of the Executive Schedule under section 

20 5315 of title 5, United States Code, and while so 

21 serving away from home and the member’s regular 

22 place of business, a member may be allowed travel 

23 expenses, as authorized by the Chairperson of the 

24 Council. Physicians who are members of the Council 

25 may be provided a physician comparability allowance 
80 

•S 2421 IS 

1 by the Council in the same manner as Government 

2 physicians may be provided such an allowance by an 

3 agency under section 5948 of title 5, United States 

4 Code. For purposes of pay (other than pay of mem5 bers of the Council) and employment benefits, 

6 rights, and privileges, all personnel of the Commis7 sion shall be treated as if they were employees of the 

8 United States Senate. 

9 (5) CHAIRPERSON; VICE CHAIRPERSON.—The 

10 Comptroller General shall designate a member of the 

11 Council, at the time of the appointment of such 

12 member, to serve as the Chairperson of the Council 

13 and another member to serve as Vice Chairperson of 

14 the Council for that term of appointment, except 

15 that in the case of the vacancy of the 

16 Chairpersonship or Vice Chairpersonship, the Comp17 troller General may designate another member to 

18 serve for the remainder of that member’s term. 

19 (6) MEETINGS.—The Council shall meet at the 

20 call of the Chairperson, but in no event less than 

21 once every 6 months. 

22 (c) DUTIES.— 

23 (1) REVIEW OF NATIONAL HEALTH CARE QUAL24 ITY.—The Council shall— 
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•S 2421 IS 

1 (A) identify national aims and objectives 

2 for health care quality improvement; 

3 (B) track the progress of the United 

4 States in meeting the aims and objectives iden5 tified under subparagraph (A); 

6 (C) make recommendations to Congress 

7 and the public concerning health care quality 

8 policies and programs for improvement; and 

9 (D) not later than March 1 of each year 

10 (beginning in 2005), submit a report to Con11 gress and the public containing the results of 

12 reviews conducted under this subsection and the 

13 recommendations of the Council concerning 

14 health care quality policies and programs. 

15 (2) TOPICS TO BE REVIEWED.— 

16 (A) NATIONAL AIMS.—The Council shall 

17 review, at the minimum, the following national 

18 aims: 

19 (i) Reducing avoidable mortality and 

20 the underlying causes of illness, injury, 

21 and disability. 

22 (ii) Expanding research on new treat23 ments and evidence on effectiveness. 

24 (iii) Assuring the appropriate use of 

25 health care services. 
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•S 2421 IS 

1 (iv) Reducing health care errors. 

2 (v) Addressing oversupply and under3 supply of health care resources. 

4 (vi) Increasing patients’ participation 

5 in their care and the public’s engagement 

6 in improving health system performance. 

7 (B) NATIONAL OBJECTIVES.—The Council 

8 shall develop measurable objectives within each 

9 of the national aims described in subparagraph 

10 (A) (as well as within any newly identified 

11 aims) and such objectives should be revised over 

12 time as improvements occur and new concerns 

13 arise. 

14 (C) QUALITY MEASUREMENT AND REPORT15 ING STANDARDS.—The Council shall conduct 

16 the following activities: 

17 (i) Conduct assessments of the ade18 quacy of current quality measures and re19 porting standards for the American popu20 lation at large as well as for sub-popu21 lations defined by age, gender, race, eth22 nicity, income, disability, and geography. 

23 (ii) Identify processes for the develop24 ment of new quality measures and report25 ing standards as needed. 
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•S 2421 IS 

1 (iii) Make recommendations to health 

2 care organizations and providers regarding 

3 quality measurement and reporting, both 

4 publicly and privately. 

5 (iv) Track the use of recommended 

6 quality measurement and reporting stand7 ards. 

8 (v) Make recommendations to Con9 gress concerning health care quality meas10 urement and reporting requirements. 

11 (D) DISPARITIES IN HEALTH CARE QUAL12 ITY.—The Council shall include as part of its 

13 overall review under this paragraph, an assess14 ment of health care quality for, at the min15 imum, the following populations: 

16 (i) Children and adolescents. 

17 (ii) Senior citizens. 

18 (iii) Disabled individuals. 

19 (iv) Racial, ethnic and limited English 

20 proficient individuals. 

21 (v) Women. 

22 (vi) Low income individuals. 

23 (vii) Geographically diverse popu24 lations. 
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•S 2421 IS 

1 (E) INTERVENTIONS FOR IMPROVEMENT

2 OF HEALTH CARE QUALITY AND HEALTH SYS3 TEM PERFORMANCE.—The Council shall con4 duct the following activities: 

5 (i) Review the evidence base to deter6 mine the most effective methods for im7 proving patient care and the performance 

8 of the health care system, including regula9 tion, accreditation, performance based pay10 ment, information technologies, manage11 ment systems, professional certification, 

12 and public reporting of data. 

13 (ii) Identify gaps and deficiencies of 

14 research to ascertain the most predictable 

15 processes and policies associated with im16 provements in quality. 

17 (iii) Make recommendations to health 

18 care organizations and providers regarding 

19 quality improvement methods, including 

20 appropriate clinical guidelines, both pub21 licly and privately. 

22 (iv) Make recommendations to Con23 gress concerning policies and processes for 

24 improvement. 
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•S 2421 IS 

1 (F) CONSUMER BILL OF RIGHTS AND RE2 SPONSIBILITIES.—The Council shall assess the 

3 implementation of this Act with attention to the 

4 following areas: 

5 (i) Information disclosure. 

6 (ii) Choice of providers and plans. 

7 (iii) Access to emergency services. 

8 (iv) Participation in treatment deci9 sions. 

10 (v) Respect and nondiscrimination. 

11 (vi) Confidentiality of health informa12 tion. 

13 (vii) Complaints and appeals. 

14 (viii) Consumer responsibilities. 

15 (3) COMMENTS ON CERTAIN SECRETARIAL RE16 PORTS.—If the Secretary of Health and Human 

17 Service (referred to in this section as the ‘‘Sec18 retary’’) submits to Congress (or a committee of 

19 Congress) a report that is required by law, and that 

20 relates to health care quality, including the National 

21 Healthcare Quality Report and the National 

22 Healthcare Disparities Report, the Secretary shall 

23 transmit a copy of the report to the Council. The 

24 Council shall review the report and, not later than 

25 6 months after the date on which such report is 
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•S 2421 IS 

1 transmitted to the Council, shall submit to the ap2 propriate committees of Congress written comments 

3 on such report. Such comments may include such 

4 recommendations as the Council determines appro5 priate. 

6 (4) AGENDA AND ADDITIONAL REVIEWS.—The 

7 Council shall consult periodically with the chairmen 

8 and ranking minority members of the appropriate 

9 committees of Congress concerning the Council’s 

10 agenda and progress towards achieving the agenda. 

11 The Council may conduct additional reviews and 

12 submit additional reports to the appropriate commit13 tees of Congress, from time to time, on such topics 

14 relating to the program under this title as may be 

15 requested by such chairperson and members and as 

16 the Council determines appropriate. 

17 (5) AVAILABILITY OF REPORTS.—The Council 

18 shall transmit to the Secretary a copy of each report 

19 submitted under this subsection and shall make such 

20 reports available to the public. 

21 (6) APPROPRIATE COMMITTEES OF CON22 GRESS.—In this section, the term ‘‘appropriate com23 mittees of Congress’’ means the Committee on Ways 

24 and Means and the Committee on Energy and Com25 merce of the House of Representatives and the Com-
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•S 2421 IS 

1 mittee on Health, Education, Labor, and Pensions 

2 and the Committee on Finance of the Senate. 

3 (d) DIRECTOR; STAFF; EXPERTS; CONSULTANTS.— 

4 Subject to such review as the Comptroller General deter5 mines necessary to ensure the efficient administration of 

6 the Council, the Council may— 

7 (1) employ and fix the compensation of an Ex8 ecutive Director (subject to the approval of the 

9 Comptroller General) and such other personnel as 

10 may be necessary to carry out its duties (without re11 gard to the provision of title 5, United States Code, 

12 governing appointments in the competitive service); 

13 (2) seek such assistance and support as may be 

14 required in the performance of its duties from ap15 propriate Federal departments and agencies; 

16 (3) enter into contracts or make other arrange17 ments, as may be necessary for the conduct of the 

18 work of the Council (without regard to section 3709 

19 of the Revised Statutes (41 U.S.C. 5)); 

20 (4) make advance, progress, and other pay21 ments which relate to the work of the Council; 

22 (5) provide transportation and subsistence for 

23 persons serving without compensation; and 
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•S 2421 IS 

1 (6) prescribe such rules and regulations as the 

2 Council determines necessary with respects to the in3 ternal organization and operation of the Council. 

4 (e) POWERS.— 

5 (1) OBTAINING OFFICIAL DATA.—The Council 

6 may secure directly from any department or agency 

7 of the United States information necessary to enable 

8 it to carry out this section. Upon request of the 

9 Chairperson, the head of such a department or agen10 cy shall furnish such information to the Council on 

11 an agreed upon schedule. 

12 (2) DATA COLLECTION.—In order to carry out 

13 its functions, the Council shall— 

14 (A) utilize existing information, both pub15 lished and unpublished, where possible, collected 

16 and assessed either by the staff of the Council 

17 or under other arrangements made in accord18 ance with this section; 

19 (B) carry out, or award grants or con20 tracts for, original research and experimen21 tation, where existing information is inad22 equate; and 

23 (C) adopt procedures allowing any inter24 ested party to submit information for the Coun-
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•S 2421 IS 

1 cil’s use in making reports and recommenda2 tions. 

3 (3) ACCESS OF GAO TO INFORMATION.—The 

4 Comptroller General shall have unrestricted access 

5 to all deliberations, records, and nonproprietary data 

6 of the Council, immediately upon request. 

7 (4) PERIODIC AUDIT.—The Council shall be 

8 subject to periodic audit by the Comptroller General. 

9 (f) AUTHORIZATION OF APPROPRIATIONS.— 

10 (1) IN GENERAL.—The Council shall submit re11 quests for appropriations in the same manner as the 

12 Comptroller General submits requests for appropria13 tions, but amounts appropriated for the Council 

14 shall be separate from amounts appropriated for the 

15 Comptroller General. 

16 (2) AUTHORIZATION.—There are authorized to 

17 be appropriated such sums as may be necessary to 

18 carry out this section. 

19 TITLE IV—PREVENTIVE HEALTH 

20 SERVICES 

21 SEC. 401. INCREASING HEALTH INSURANCE COVERAGE 

22 FOR PREVENTION. 

23 (a) APPLICATION TO GROUP HEALTH PLANS AND

24 GROUP HEALTH INSURANCE COVERAGE UNDER THE

25 PUBLIC HEALTH SERVICE ACT.— 
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•S 2421 IS 

1 (1) IN GENERAL.—Subpart 2 of part A of title 

2 XXVII of the Public Health Service Act, as amend3 ed by section 121, is further amended by adding at 

4 the end the following new section: 

5 ‘‘SEC. 2708. STANDARDS RELATING TO BENEFITS FOR PRE6 VENTIVE SERVICES. 

7 ‘‘(a) REQUIREMENTS FOR COVERAGE.—A group 

8 health plan, and a health insurance issuer providing health 

9 insurance coverage in connection with a group health plan, 

10 shall provide coverage for preventive health care items and 

11 services specified by the Secretary under section 401(c) 

12 of the Health Care Modernization, Cost Reduction, and 

13 Quality Improvement Act. 

14 ‘‘(b) APPLICATION OF CERTAIN PROVISIONS.—The 

15 provisions of subsections (b) (relating to notice), (c) (relat16 ing to prohibitions), (d) (relating to rules of construction), 

17 and (e) (relating to preemption) of section 713 of the Em18 ployee Retirement Income Security Act of 1974 shall 

19 apply to subsection (a) in the same manner as such sub20 sections apply to subsection (a) of such section 713, except 

21 that the date provided for in subsection (b)(3) shall be 

22 January 1, 2005.’’. 

23 (2) CONFORMING AMENDMENT.—Section 

24 2721(b)(2)(A) of the Public Health Service Act (42 

25 U.S.C. 300gg–21(b)(2)(A)) is amended by inserting 
91 

•S 2421 IS 

1 ‘‘(other than sections 2707 and 2708)’’ after ‘‘re2 quirements of such subparts’’. 

3 (b) APPLICATION TO GROUP HEALTH PLANS AND

4 GROUP HEALTH INSURANCE COVERAGE UNDER THE EM5 PLOYEE RETIREMENT INCOME SECURITY ACT OF 1974.— 

6 (1) IN GENERAL.—Subpart B of part 7 of sub7 title B of title I of the Employee Retirement Income 

8 Security Act of 1974, as amended by section 123, is 

9 further amended by adding at the end the following 

10 new section: 

11 ‘‘SEC. 715. STANDARDS RELATING TO BENEFITS FOR PRE12 VENTIVE SERVICES. 

13 ‘‘(a) REQUIREMENTS FOR COVERAGE.—A group 

14 health plan, and a health insurance issuer providing health 

15 insurance coverage in connection with a group health plan, 

16 shall provide coverage for preventive health care items and 

17 services specified by the Secretary under section 401(c) 

18 of the Health Care Modernization, Cost Reduction, and 

19 Quality Improvement Act. 

20 ‘‘(b) APPLICATION OF CERTAIN PROVISIONS.—The 

21 provisions of subsections (b) (relating to notice), (c) (relat22 ing to prohibitions), (d) (relating to rules of construction), 

23 and (e) (relating to preemption) of section 713 shall apply 

24 to subsection (a) in the same manner as such subsections 

25 apply to subsection (a) of such section 713, except that 
92 

•S 2421 IS 

1 the date provided for in subsection (b)(3) shall be January 

2 1, 2005.’’. 

3 (2) CONFORMING AMENDMENTS.— 

4 (A) IN GENERAL.—Section 732(a) of the 

5 Employee Retirement Income Security Act of 

6 1974 (29 U.S.C. 1185(a)) is amended by strik7 ing ‘‘section 711’’ and inserting ‘‘sections 711, 

8 714 and 715’’. 

9 (B) TABLE OF CONTENTS.—The table of 

10 contents in section 1 of the Employee Retire11 ment Income Security Act of 1974 is amended 

12 by inserting after the item relating to section 

13 714 the following new item: 

‘‘Sec. 715. Standards relating to benefits for preventive services.’’. 

14 (c) PREVENTIVE HEALTH CARE ITEMS AND SERV15 ICES.—Not later than January 1, 2005, the Secretary of 

16 Health and Human Services, in consultation with the 

17 United States Preventive Services Task Force, shall speci18 fy those preventive health care items and services to be 

19 covered by group health plans and health insurance issuers 

20 under the amendments made by this section. In specifying 

21 such items and services, the Secretary shall consider the 

22 cost and effectiveness of such items and services. 

23 (d) EFFECTIVE DATE.—The amendments made by 

24 this section shall apply with respect to group health plans 
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•S 2421 IS 

1 and health insurance issuers for plan years beginning on 

2 or after January 1, 2005. 

3 SEC. 402. ACTIVITIES RELATING TO NUTRITION AND PHYS4 ICAL ACTIVITY. 

5 Title III of the Public Health Service Act (42 U.S.C. 

6 241 et seq.), as amended by section 303, is further amend7 ed by adding at the end the following: 

8 ‘‘PART U—PREVENTIVE HEALTH CARE 

9 ‘‘SEC. 399D. ENCOURAGING HEALTHY DIETS. 

10 ‘‘(a) IN GENERAL.—The Secretary, in collaboration 

11 with the Director of the Centers for Disease Control and 

12 Prevention, the Secretary of Education, and the Secretary 

13 of Agriculture, shall establish and implement activities to 

14 encourage health dietary choices (such as fruits and vege15 tables, and foods that are low in fat, sugar, and salt) in 

16 schools, worksites, and communities. 

17 ‘‘(b) SCHOOLS.—The Secretary, in collaboration with 

18 the Director of the Centers for Disease Control and Pre19 vention, the Secretary of Agriculture, and the Secretary 

20 of Education, shall require elementary and secondary 

21 schools that receive Federal funds to— 

22 ‘‘(1) ban soft drinks or other foods of minimal 

23 nutritional value from vending machines; 

24 ‘‘(2) maintain a minimum number of func25 tioning water fountains in school buildings; 
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•S 2421 IS 

1 ‘‘(3) prohibit advertisements in schools and on 

2 school grounds for foods of minimal nutritional value 

3 such as fast foods, beverages, and snack foods of 

4 which greater than 50 percent of the calories are de5 rived from fat or simple sugars; and 

6 ‘‘(4) integrate into school curricula education 

7 about lifelong healthy eating. 

8 ‘‘(c) WORKSITES.—The Secretary, in collaboration 

9 with the Director of the Centers for Disease Control and 

10 Prevention, the Secretary of Agriculture, and the Sec11 retary of Labor, shall— 

12 ‘‘(1) ensure the availability of meal selections in 

13 cafeterias, snack stands, and vending machines in 

14 Federal Government buildings that meet the rec15 ommendations of the Secretary for nutritional con16 tent and portion size; 

17 ‘‘(2) require clear and effective labeling of cal18 ories, fat, trans fat, sugar, sodium, and portion size 

19 for meal selections served in cafeterias and all foods 

20 and beverages sold in vending machines, and at 

21 snack stands in Federal Government buildings, as 

22 determined appropriate by the Secretary; 

23 ‘‘(3) work with unions, employee associations, 

24 and employer associations to provide technical as25 sistance for the establishment of employee incentive 
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•S 2421 IS 

1 programs to increase participation in worksite health 

2 promotion programs that encourage diets in accord3 ance with national standards promulgated by the 

4 Secretary; and 

5 ‘‘(4) establish incentive programs to enable em6 ployers to partner with local farmers, farmers mar7 kets, grocers, and restaurants to increase accessi8 bility and availability of fresh fruits and vegetables 

9 through worksite cafeterias, snack bars, and vending 

10 machines. 

11 ‘‘(d) COMMUNITIES.—The Secretary, acting through 

12 the Director of the Centers for Disease Control and Pre13 vention, shall award grants for projects that— 

14 ‘‘(1) implement campaigns, in communities at 

15 risk for poor nutrition, that are designed to promote 

16 the intake of foods consistent with established die17 tary guidelines through the use of different types of 

18 media including television, radio, newspapers, movie 

19 theaters, billboards, and mailings; 

20 ‘‘(2) implement campaigns, in communities at 

21 risk for poor nutrition, that promote water as the 

22 main daily drink choice through the use of different 

23 types of media including television, radio, news24 papers, movie theaters, billboards, and mailings; 
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•S 2421 IS 

1 ‘‘(3) conduct outreach to commercial food es2 tablishments, grocery stores, and other food sup3 pliers, to increase the availability and accessibility of 

4 healthy foods and beverages; 

5 ‘‘(4) partner with national programs that pro6 vide parents and mentors with the skills to help 

7 guide and influence healthy meals and snack selec8 tions for children and adolescents; or 

9 ‘‘(5) partner with national afterschool and sum10 mer programs that provide children with the edu11 cation and skills needed to make healthy meal and 

12 snack selections. 

13 ‘‘(e) HEALTH PROFESSIONALS.—The Secretary, act14 ing through the Administrator of the Health Resources 

15 and Services Administration, shall award grants to— 

16 ‘‘(1) support the development, implementation, 

17 and evaluation of curricula to educate and train 

18 health professionals about effective nutrition edu19 cation and counseling strategies for obese individuals 

20 and parents of overweight children, with emphasis 

21 on the Dietary Guidelines for Americans or other 

22 nationally accepted standards; or 

23 ‘‘(2) use web-based and related technologies to 

24 develop, implement, and evaluate the effectiveness of 

25 dietary counseling in health care settings. 
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•S 2421 IS 

1 ‘‘(f) EVALUATION.—Not later than 12 months after 

2 the date on which a grant is awarded under this section, 

3 the grantee shall submit to the Director of the Centers 

4 for Disease Control and Prevention a report that describes 

5 the activities carried out with funds received under the 

6 grant and the effectiveness of such activities in improving 

7 the intake of nutritional foods. 

8 ‘‘(g) AUTHORIZATION OF APPROPRIATIONS.—There 

9 is authorized to be appropriated to carry out this section, 

10 such sums as may be necessary for each of fiscal years 

11 2005 through 2010. 

12 ‘‘SEC. 399D–1. INCREASING PHYSICAL ACTIVITY. 

13 ‘‘(a) IN GENERAL.—The Secretary, in collaboration 

14 with the Director of the Centers for Disease Control and 

15 Prevention, the Secretary of Education, the Secretary of 

16 Labor, and the Director of the Federal Highway Adminis17 tration, shall establish and implement activities for the 

18 purpose of increasing physical activity in schools, work19 sites, and communities. 

20 ‘‘(b) SCHOOLS.—The Director of the Centers for Dis21 ease Control and Prevention, in collaboration with the Sec22 retary of Education shall award grants to public elemen23 tary and secondary schools for programs that support— 

24 ‘‘(1) the provision of daily physical education 

25 for students in kindergarten through grade 12 
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•S 2421 IS 

1 through programs that are consistent with the 

2 Guidelines for Physical Activity as reported by the 

3 Centers for Disease Control and Prevention and the 

4 American College of Sports Medicine and National 

5 Physical Education Standards; 

6 ‘‘(2) the implementation of comprehensive 

7 school curricula and school-based physical activity 

8 programs that provide education about lifelong phys9 ical activity; 

10 ‘‘(3) training for school personnel that provides 

11 the knowledge and skills needed to effectively teach 

12 lifelong physical activity; or 

13 ‘‘(4) evaluations of school physical education 

14 programs and facilities at annual intervals to deter15 mine the extent to which national guidelines de16 scribed in paragraph (1) are met. 

17 ‘‘(c) WORKSITES.—The Director of the Centers for 

18 Disease Control and Prevention, in collaboration with the 

19 Secretary, and the Secretary of Labor, shall award grants 

20 to eligible entities as determined by the Director, which 

21 may include labor organizations, trade associations, trade 

22 groups, and businesses for the establishment of projects 

23 that include— 

24 ‘‘(1) the development of activity friendly work25 sites (which may include the provision of facilities 
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•S 2421 IS 

1 for physical activity, accessible and attractive stair2 wells, walking trails, and supportive management 

3 practices) that encourage employee participation in 

4 physical activity; 

5 ‘‘(2) the development of worksite wellness pro6 grams that improve physical activity by increasing 

7 the knowledge, attitudes, skills, and behaviors of em8 ployees; and 

9 ‘‘(3) the development of employee incentive pro10 grams (such as cafeteria discounts, health club 

11 memberships, small cash bonuses, and time off) to 

12 increase the participation of employees in worksite 

13 health promotion programs that increase physical 

14 activity. 

15 ‘‘(d) COMMUNITIES.—The Director of the Centers for 

16 Disease Control and Prevention, in collaboration with the 

17 Secretary, the Secretary of Transportation, and Secretary 

18 of the Interior, shall award grants for the implementation 

19 and evaluation of activities that may include— 

20 ‘‘(1) projects to design pedestrian zones and 

21 construct safe walkways and cycling paths; 

22 ‘‘(2) projects that create greenways and open23 space areas linking parks, nature preserves, and cul24 tural or historic sites with each other and with popu-
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•S 2421 IS 

1 lated areas such as residential communities and 

2 business locations; 

3 ‘‘(3) initiatives to increase the use of walking 

4 and bicycling as a transportation mode by creating 

5 or enhancing informational outreach to parks or 

6 community recreation centers; and 

7 ‘‘(4) community-wide campaigns designed to in8 crease physical activity as part of multicomponent 

9 efforts that include strategies such as support of self 

10 help groups, physical activity counseling, risk factor 

11 screening and education, and environmental or pol12 icy changes such as the creation of walking trails. 

13 ‘‘(e) EVALUATION.—Not later than 2 years after the 

14 date on which a grant is awarded under this section, the 

15 grantee shall submit to the Director of the Centers for 

16 Disease Control and Prevention a report that describes the 

17 activities carried out with funds receive under the grant 

18 and the effectiveness of such activities in increasing phys19 ical activity. 

20 ‘‘(f) AUTHORIZATION OF APPROPRIATIONS.—There 

21 is authorized to be appropriated to carry out this section, 

22 such sums as may be necessary for each of fiscal years 

23 2005 through 2010.’’. 
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•S 2421 IS 

1 SEC. 403. IMPROVING IMMUNIZATION. 

2 Title III of the Public Health Service Act (42 U.S.C. 

3 241 et seq.), as amended by section 402, is further amend4 ed by adding at the end the following: 

5 ‘‘PART V—IMPROVING IMMUNIZATION 

6 ‘‘SEC. 399E. PROGRAMS TO IMPROVE THE RATE OF IMMUNI7 ZATION IN ADULTS AND ADOLESCENTS. 

8 ‘‘(a) DEMONSTRATION PROJECTS.—The Secretary, 

9 acting through the Director of the Centers for Disease 

10 Control and Prevention, shall award supplemental grants 

11 under section 317 to eligible entities for the development, 

12 implementation, and evaluation of evidence-based pro13 grams that improve the rate of immunization of adults 

14 and adolescents. 

15 ‘‘(b) ELIGIBILITY.—To be eligible to receive a grant 

16 under this section an entity shall— 

17 ‘‘(1) be— 

18 ‘‘(A) a hospital; 

19 ‘‘(B) an academic institution; 

20 ‘‘(C) a nonprofit community based organi21 zation; 

22 ‘‘(D) a health center; or 

23 ‘‘(E) any other public or private nonprofit 

24 entity determined appropriate by the Director 

25 of the Centers for Disease Control and Preven26 tion; 
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•S 2421 IS 

1 ‘‘(2) establish a partnership with a State or 

2 local government for purposes of carrying out activi3 ties under this section; and 

4 ‘‘(3) prepare and submit to the Director of the 

5 Centers for Disease Control and Prevention an ap6 plication at such time, in such manner, and con7 taining such information as the Director may re8 quire. 

9 ‘‘(c) USE OF FUNDS.—An entity shall use amounts 

10 received under a grant under this section to conduct 

11 projects to carry out activities consistent with evidence12 based strategies recommended by the Advisory Committee 

13 on Immunization Practices and the Task Force on Com14 munity Preventive Services, including— 

15 ‘‘(1) the conduct of public information and edu16 cation campaigns that will promote adult and adoles17 cent immunizations recommended by the Advisory 

18 Committee on Immunization Practices, through the 

19 development and dissemination to targeted audiences 

20 of appropriate messages about the risks and benefits 

21 of immunizations; 

22 ‘‘(2) the conduct of programs to offer vaccines 

23 to underimmunized adult and adolescent populations 

24 in settings that have not previously or routinely pro25 vided these services, such as family planning, HIV, 
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•S 2421 IS 

1 sexually transmitted disease, and drug treatment 

2 centers, emergency departments, pharmacies, home 

3 care agencies, senior citizen homes, and correctional 

4 facilities; 

5 ‘‘(3) the conduct of provider-based interventions 

6 to promote adult and adolescent vaccinations rec7 ommended by the Advisory Committee on Immuniza8 tion Practices, which shall include— 

9 ‘‘(A) the development and implementation 

10 of reminder or recall systems that align with 

11 State and local immunization information sys12 tems and inform health care providers when 

13 adult and adolescent patients are due or over14 due for specific vaccinations; and 

15 ‘‘(B) the establishment of standing orders 

16 in which non-physician medical personnel de17 liver adult and adolescent vaccinations without 

18 direct physician involvement at the time of the 

19 visit; and 

20 ‘‘(4) the conduct of programs to identify other 

21 interventions and to translate interventions into 

22 practice. 

23 ‘‘(d) DISSEMINATION.—The Director of the Centers 

24 for Disease Control and Prevention shall publish and dis25 seminate findings made as a result of activities conducted 
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•S 2421 IS 

1 under this section to the public in coordination with the 

2 heads of other appropriate Federal agencies. 

3 ‘‘(e) AUTHORIZATION OF APPROPRIATIONS.—There 

4 is authorized to be appropriated to carry out this section, 

5 such sums as may be necessary for each of fiscal years 

6 2005 through 2009. 

7 ‘‘SEC. 399E–1. CURRICULUM DEVELOPMENT. 

8 ‘‘(a) IN GENERAL.—The Director of the Centers for 

9 Disease Control and Prevention shall award competitive 

10 cooperative agreements for the development of innovative 

11 curricula for health care provider training and continuing 

12 education for practicing professionals concerning the as13 sessment, monitoring, improvement, and delivery of immu14 nizations for adults, adolescents, and children. 

15 ‘‘(b) ELIGIBILITY.—To be eligible to receive a cooper16 ative agreement under this section an entity shall— 

17 ‘‘(1) be— 

18 ‘‘(A) an academic institution, such as a 

19 school of medicine, nursing, or pharmacy; or 

20 ‘‘(B) any other public or private nonprofit 

21 entity determined to be appropriate by the Di22 rector of the Centers for Disease Control and 

23 Prevention; and 

24 ‘‘(2) prepare and submit to the Director of the 

25 Centers for Disease Control and Prevention an ap-
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1 plication at such time, in such manner, and con2 taining such information as the Director of the Cen3 ters for Disease Control may require. 

4 ‘‘(c) USE OF FUNDS.—An entity shall use amounts 

5 received under a cooperative agreement under this section 

6 to develop, implement, and evaluate curricula for health 

7 care providers that use innovative educational methods, to 

8 promote the awareness and implementation of immuniza9 tions for adults, adolescents, and children. Such curricula 

10 may include distance learning courses and CD–Rom and 

11 web-based educational programs. 

12 ‘‘(d) AUTHORIZATION OF APPROPRIATIONS.—There 

13 is authorized to be appropriated to carry out this section, 

14 such sums as may be necessary for each of fiscal years 

15 2005 through 2009. 

16 ‘‘SEC. 399E–2. ASSURING ADEQUATE SUPPLY OF VACCINES 

17 FOR ADULT AND ADOLESCENT IMMUNIZA18 TION PROGRAMS. 

19 ‘‘(a) IN GENERAL.—The Director of the Centers for 

20 Disease Control and Prevention shall award competitive 

21 supplemental grants to immunization grantees under sec22 tion 317 to ensure that there is an adequate supply of 

23 vaccines for adults and adolescents. 

24 ‘‘(b) ELIGIBILITY.—To be eligible to receive a grant 

25 under this section, an entity shall— 
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1 ‘‘(1) be an entity determined appropriate by the 

2 Director of the Centers for Disease Control and Pre3 vention; and 

4 ‘‘(2) prepare and submit to the Director of the 

5 Centers for Disease Control and Prevention an ap6 plication at such time, in such manner, and con7 taining such information as the Director may re8 quire. 

9 ‘‘(c) USE OF FUNDS.—An entity shall use amounts 

10 received under a grant under this section to ensure the 

11 availability of vaccines and related supplies to support the 

12 implementation of programs to improve the rate of immu13 nization in adults and adolescents. 

14 ‘‘(d) AUTHORIZATION OF APPROPRIATIONS.—There 

15 is authorized to be appropriated to carry out this section, 

16 such sums as may be necessary for each of fiscal years 

17 2005 through 2009. 

18 ‘‘SEC. 399E–3. RESEARCH ON IMMUNIZATION PROGRAMS. 

19 ‘‘(a) EFFICACY RESEARCH PROJECTS.—The Sec20 retary, acting through the Director of the Centers for Dis21 ease Control and Prevention, shall award cooperative 

22 agreements to eligible entities for the conduct of research 

23 and other activities to improve immunization program’s 

24 for adults and adolescents. 
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1 ‘‘(b) ELIGIBILITY.—To be eligible to receive a grant 

2 under this section an entity shall— 

3 ‘‘(1) be— 

4 ‘‘(A) an academic institution; 

5 ‘‘(B) a nonprofit community based organi6 zation; 

7 ‘‘(C) a State or local health agency; or 

8 ‘‘(D) any other public or private nonprofit 

9 entity determined to be appropriate by the Di10 rector of the Centers for Disease Control and 

11 Prevention; and 

12 ‘‘(2) prepare and submit to the Director of the 

13 Centers for Disease Control and Prevention an ap14 plication at such time, in such manner, and con15 taining such information as the Director may re16 quire. 

17 ‘‘(c) USE OF FUNDS.—An entity shall use amounts 

18 received under a grant under this section to conduct pro19 spective and other research projects on the effect of immu20 nization programs in high-risk and underimmunized popu21 lations on the rates of immunization, incidence of influ22 enza, pneumococcal disease, hepatitis A, hepatitis B, and 

23 other vaccine-preventable diseases and related complica24 tions. 
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1 ‘‘(d) DISSEMINATION.—The Director of the Centers 

2 for Disease Control and Prevention shall disseminate find3 ings made as a result of activities conducted under this 

4 section to the public in coordination with the heads of 

5 other appropriate Federal agencies. 

6 ‘‘(e) AUTHORIZATION OF APPROPRIATIONS.—There 

7 is authorized to be appropriated to carry out this section, 

8 such sums as may be necessary for each of fiscal years 

9 2005 through 2009. 

10 ‘‘SEC. 399E–4. DEFINITION. 

11 ‘‘In this part, the term ‘State’ has the meaning given 

12 such term in section 2, and includes Indian tribes.’’. 

13 SEC. 404. IMPROVING ORAL HEALTH. 

14 Title III of the Public Health Service Act (42 U.S.C. 

15 241 et seq.), as amended by section 403, is further amend16 ed by adding at the end the following: 

17 ‘‘PART W—IMPROVING ORAL HEALTH 

18 ‘‘SEC. 399F. PUBLIC EDUCATION. 

19 ‘‘(a) DEMONSTRATION PROJECTS.—The Secretary, 

20 acting through the Director of the Centers for Disease 

21 Control and Prevention, shall award competitive grants to 

22 eligible entities for the conduct of public education cam23 paigns to raise public awareness concerning oral health. 

24 ‘‘(b) ELIGIBILITY.—To be eligible to receive a grant 

25 under this section, an entity shall— 
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1 ‘‘(1) be— 

2 ‘‘(A) a State health agency; 

3 ‘‘(B) an academic institution; 

4 ‘‘(C) a nonprofit or community organiza5 tion; or 

6 ‘‘(D) any other public or private nonprofit 

7 entity determined to be appropriate by the Di8 rector of the Centers for Disease Control and 

9 Prevention; and 

10 ‘‘(2) prepare and submit to the Director of the 

11 Centers for Disease Control and Prevention an ap12 plication at such time, in such manner, and con13 taining such information as the Director may re14 quire. 

15 ‘‘(c) USE OF FUNDS.—An entity shall use amounts 

16 received under a grant under this section to partner with 

17 a State to— 

18 ‘‘(1) increase public awareness of oral health 

19 issues through public outreach campaigns, particu20 larly targeting adult populations including those 

21 with intellectual disabilities, and those with chronic 

22 diseases such as diabetes; and 

23 ‘‘(2) develop, implement, and evaluate programs 

24 that promote oral health in adults. 
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1 ‘‘(d) DISSEMINATION.—The Director of the Centers 

2 for Disease Control and Prevention shall disseminate find3 ings made as a result of activities conducted under this 

4 section to the public in coordination with the heads of 

5 other appropriate Federal agencies. 

6 ‘‘(e) EVALUATION.—A grantee under this section 

7 shall submit to the Director of the Centers for Disease 

8 Control and Prevention an evaluation that describes activi9 ties carried out with funds received under the grant and 

10 the effectiveness of such activities in improving oral health 

11 among adults including those with intellectual disabilities 

12 or with chronic disease. 

13 ‘‘(f) AUTHORIZATION OF APPROPRIATIONS.—There 

14 is authorized to be appropriated to carry out this section, 

15 such sums as may be necessary for each of fiscal years 

16 2005 through 2009. 

17 ‘‘SEC. 399F–1. HEALTH CARE PROVIDER EDUCATION. 

18 ‘‘(a) IN GENERAL.—The Director of the Centers for 

19 Disease Control and Prevention shall award competitive 

20 grants to entities for the development of innovative cur21 ricula for health care providers concerning the delivery of 

22 oral care to adults, including adults with intellectual dis23 abilities or with chronic disease. 

24 ‘‘(b) ELIGIBILITY.—To be eligible to receive a grant 

25 under this section, an entity shall— 
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1 ‘‘(1) be— 

2 ‘‘(A) an academic institution; 

3 ‘‘(B) a health center; or 

4 ‘‘(C) any other entity determined appro5 priate by the Director of the Centers for Dis6 ease Control and Prevention; and 

7 ‘‘(2) prepare and submit to the Director of the 

8 Centers for Disease Control and Prevention an ap9 plication at such time, in such manner, and con10 taining such information as the Director may re11 quire. 

12 ‘‘(c) USE OF FUNDS.—An entity shall use amounts 

13 received under a grant under this section to develop, im14 plement, and evaluate innovative curricula for health care 

15 providers that promotes oral health for adults, including 

16 adults with intellectual disabilities or with chronic disease. 

17 ‘‘(d) AUTHORIZATION OF APPROPRIATIONS.—There 

18 is authorized to be appropriated to carry out this section, 

19 such sums as may be necessary for each of fiscal years 

20 2005 through 2009. 

21 ‘‘SEC. 399F–2. MONITORING AND EVALUATING THE QUALITY 

22 OF ORAL HEALTH. 

23 ‘‘(a) DEMONSTRATION PROJECTS.—The Secretary, 

24 acting through the Director of the Centers for Disease 

25 Control and Prevention, shall award competitive grants to 
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1 States to expand the ability of States to improve the qual2 ity of oral health among adults including adults with intel3 lectual disabilities or with chronic disease. 

4 ‘‘(b) ELIGIBILITY.—To be eligible to receive a grant 

5 under this section a State shall prepare and submit to the 

6 Director of the Centers for Disease Control and Preven7 tion an application at such time, in such manner, and con8 taining such information as the Director may require. 

9 ‘‘(c) CONTRACTING AUTHORITY.—A State receiving 

10 a grant under this section may enter into contracts with 

11 academic institutions, and other entities determined to be 

12 appropriate by the Director, to carry out activities author13 ized under this section. 

14 ‘‘(d) USE OF FUNDS.—A State shall use amounts re15 ceived under a grant under this section for activities to 

16 improve the oral health of adults, including adults with 

17 intellectual disabilities or chronic diseases. Such activities 

18 may include— 

19 ‘‘(1) the collection of public health surveillance 

20 information; 

21 ‘‘(2) the analysis of data to determine the oral 

22 health status of adults; 

23 ‘‘(3) the development and implementation of 

24 interventions to improve oral health; 
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•S 2421 IS 

1 ‘‘(4) the dissemination of evidence-based best 

2 practices; and 

3 ‘‘(5) the coordination of the sharing of oral 

4 health data and evidence based practices between 

5 States. 

6 ‘‘(e) PRIVACY.—A State receiving a grant, or an enti7 ty entering into a contract, under this section shall comply 

8 with appropriate security and privacy protocols (including 

9 protocols required under the regulations promulgated 

10 under section 264(c) of the Health Insurance Portability 

11 and Accountability Act of 1996 (42 U.S.C. 1320d–2 

12 note)), if applicable, with respect to information collected 

13 under this section. Nothing in this section shall be con14 strued to supersede applicable Federal or State privacy 

15 laws. 

16 ‘‘(f) EVALUATION.—A grantee under this section 

17 shall submit to the Director of the Centers for Disease 

18 Control and Prevention an evaluation that describes the 

19 activities conducted with funds received under the grant 

20 and the effectiveness of such activities in improving oral 

21 health among adults, including adults with intellectual dis22 abilities or with chronic disease. 

23 ‘‘(g) AUTHORIZATION OF APPROPRIATIONS.—There 

24 is authorized to be appropriated to carry out this section 
114 

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1 and such sums as may be necessary for each of fiscal years 

2 2005 through 2009. 

3 ‘‘SEC. 399F–3. STUDIES AND REPORTS BY THE INSTITUTE 

4 OF MEDICINE. 

5 ‘‘(a) CONTRACT.—The Secretary shall enter into a 

6 contract with the Institute of Medicine to assess existing 

7 gaps in, and impediments to, quality oral health, including 

8 gaps in data, research and translation, and care provided 

9 to adult populations. 

10 ‘‘(b) AUTHORIZATION OF APPROPRIATIONS.—There 

11 is authorized to be appropriated to carry out this section, 

12 such sums as may be necessary for each of fiscal years 

13 2005 through 2009. 

14 ‘‘SEC. 399F–4. DEFINITION. 

15 ‘‘In this part, the term ‘State’ has the meaning given 

16 such term in section 2, and includes Indian tribes.’’. 

Æ