I 

108TH CONGRESS 

1ST SESSION H. R. 2741

To provide for a comprehensive Federal effort relating to early detection 

of, treatments for, and the prevention of cancer, and for other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

JULY 15, 2003

Mrs. CAPPS (for herself, Mr. GEORGE MILLER of California, Mrs. MALONEY, 

Mr. FROST, and Mr. TOWNS) introduced the following bill; which was referred to the Committee on Energy and Commerce, and in addition to 

the Committees on Education and the Workforce and Ways and Means, 

for a period to be subsequently determined by the Speaker, in each case 

for consideration of such provisions as fall within the jurisdiction of the 

committee concerned 

A BILL

To provide for a comprehensive Federal effort relating to 

early detection of, treatments for, and the prevention 

of cancer, and for other purposes.

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled,
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1 SECTION 1. SHORT TITLE; TABLE OF CONTENTS. 

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

3 ‘‘National Cancer Act of 2003’’. 

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

5 this Act is as follows:

Sec. 1. Short title; table of contents. 

Sec. 2. Findings. 

TITLE I—EXPANSION OF CANCER-RELATED RESEARCH, 

PREVENTION, DETECTION, AND TREATMENT PROGRAMS 

Sec. 101. Sense of the House of Representatives concerning investments in cancer research funding. 

Sec. 102. Sense of the House of Representatives concerning investments in cancer research to develop targeted drugs. 

Sec. 103. Expansion of cancer-related research, prevention, detection, treatment, and survivorship programs. 

Sec. 104. National Institute for Environmental Health Sciences. 

Sec. 105. Comprehensive cancer control plans. 

Sec. 106. Breast, cervical, and colorectal cancer screening. 

Sec. 107. IHS grants for model community cancer and chronic disease care and 

prevention; IHS grants for patient navigators. 

TITLE II—EXPANDING ACCESS TO CANCER DRUGS AND 

TREATMENT 

Sec. 201. Acceleration of the drug treatment approval process of the Food and 

Drug Administration. 

Sec. 202. FDA amendment. 

TITLE III—CANCER-RELATED HEALTH INSURANCE COVERAGE 

Subtitle A—Clinical Trials Coverage 

Sec. 301. Coverage for clinical trials under the Public Health Service Act. 

Sec. 302. Coverage for clinical trials under the Employee Retirement Income 

Security Act of 1974. 

Sec. 303. Coverage for clinical trials under other public health insurance. 

Subtitle B—Cancer Screening and Other Coverage 

Sec. 311. Cancer screening coverage. 

Subtitle C—Physicians and Quality of Care 

Sec. 321. Managing physicians and quality of care for cancer patients under 

the Public Health Service Act. 

Sec. 322. Managing physicians and quality of care for cancer patients under 

the Employee Retirement Income Security Act of 1974. 

Sec. 323. Managing physicians and quality of care for cancer patients under 

medicare. 
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Sec. 324. Managing physicians and quality of care for cancer patients under 

medicaid and SCHIP. 

Subtitle D—General Provisions 

Sec. 331. Coverage under other public health insurance. 

TITLE IV—PATIENT NAVIGATOR AND CANCER CARE WITHIN THE 

HEALTH RESOURCES AND SERVICES ADMINISTRATION 

Sec. 401. HRSA grants for model community cancer and chronic disease care 

and prevention and grants for patient navigators.

1 SEC. 2. FINDINGS. 

2 Congress makes the following findings: 

3 (1) Each year 1,300,000 Americans are diag4 nosed with cancer. Each year 560,000 Americans die 

5 from cancer. Approximately 40 percent of all Ameri6 cans in the United States will be diagnosed with 

7 cancer at some point in their lives. 

8 (2) Since 1971, when the National Cancer Act 

9 was enacted, and the ‘‘War on Cancer’’ was de10 clared, the science of cancer has advanced dramati11 cally. The revolution in molecular and cellular biol12 ogy has created unprecedented opportunities for un13 derstanding cancer and the role of genetics, environ14 mental risk factors, and lifestyle factors in relation 

15 to cancer. 

16 (3) Since 1971, mortality rates for some can17 cers have decreased, while such rates for other can18 cers have not. 

19 (4) Since 1971, the Nation’s population has be20 come increasingly diverse and cancer affects various 
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1 minority, socioeconomic, and ethnic groups dis2 proportionately. 

3 (5) Cancer screening can reduce cancer mor4 tality, in some cases by 30 percent or more. While 

5 effective screening tools have yet to be developed for 

6 the majority of cancers, proven screening tools for 

7 early detection do exist for some of the more com8 mon cancers. Screening for some cancers, such as 

9 breast, colorectal, and cervical cancers, has improved 

10 dramatically; however, screening rates are still lower 

11 than optimal. Cancer screening rates vary by cancer 

12 site, population group, and health insurance cov13 erage. 

14 (6) Public and private health insurance cov15 erage offered in the United States has dramatically 

16 changed since 1971. Today, managed care coverage 

17 is more typical than the fee-for-service coverage that 

18 was more common in the past. This change in the 

19 form of coverage has introduced more economic con20 siderations into medical decisionmaking, which can 

21 affect the quality of all health care provided, includ22 ing cancer care. 

23 (7) Fewer than 5 percent of adult cancer pa24 tients participate in cancer trials. 
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1 (8) New translational cancer research centers 

2 are needed to provide the preclinical and early clin3 ical trials support required to advance scientific dis4 coveries into new drugs and technologies to prevent, 

5 detect, treat, and diagnose cancer. 

6 (9) The quality of cancer care is uneven across 

7 the Nation and can be based on pure coincidence of 

8 where one lives. Many cancer patients do not receive 

9 optimal care. 

10 (10) Cancer is a disease of aging and as the 

11 American population ages, cancer incidence will 

12 grow. It is estimated that the number of cancer di13 agnoses in 2010 will increase by 20 percent. The 

14 number of cancer deaths is anticipated to increase 

15 by 20 percent, at an annual cost of over 

16 $200,000,000,000. With such increases in the inci17 dence of cancer, there will be a serious shortage of 

18 individuals in the workforce to provide cancer care, 

19 particularly in long-term care settings. 

20 (11) The number of medical researchers is de21 clining, a decrease which will negatively affect the 

22 prevention, detection, and treatment of cancer. 

23 (12) Since 1971, there has been a shift in can24 cer care, such as the administration of chemo-
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1 therapy, moving from inpatient to outpatient set2 tings.

3 (13) Since 1971, the conduct of research has 

4 involved more collaboration between the public and 

5 private sectors and more multidisciplinary ap6 proaches. The biotechnology pharmaceutical and de7 vice industry has grown and provided a broad array

8 of new treatment options and scientific opportunities 

9 for cancer patients, providers, and researchers. 

10 (14) Since 1971, technology and communica11 tions have expanded and increased in complexity, 

12 transforming research methodologies and making the 

13 accessing and transmitting of information more 

14 widespread and more readily available. 

15 (15) Tobacco use is the leading preventable 

16 cause of disease and premature death in the United 

States, resulting in 1 17 ⁄3 of all cancer deaths, including 

18 87 percent of lung cancer deaths. Research consist19 ently shows that smoking cessation services can be 

20 1 of the most cost-effective health interventions and 

21 can reduce smoking-related health care costs. Ces22 sation services offered as a combination of tobacco 

23 medication therapy and counseling effectively help 

24 smokers quit successfully and prevent premature 

25 death from tobacco-related cancers. 
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1 TITLE I—EXPANSION OF CAN2 CER-RELATED RESEARCH, 

3 PREVENTION, DETECTION, 

4 AND TREATMENT PROGRAMS 

5 SEC. 101. SENSE OF THE HOUSE OF REPRESENTATIVES 

6 CONCERNING INVESTMENTS IN CANCER RE7 SEARCH FUNDING. 

8 It is the sense of the House of Representatives that—

9 (1) past investments in cancer research have re10 sulted in better health, an improved quality of life, 

11 and a reduction in national health care expenditures; 

12 and 

13 (2) to build on, and sustain, the progress made 

14 over the past 5 years during which Congress doubled 

15 the budget at the National Institutes of Health, the 

16 National Cancer Institute requires continued in17 creases in Federal funding, as outlined in the Na18 tional Cancer Institute Directors Bypass Budget, to 

19 achieve a balanced research portfolio and to develop 

20 more targeted, more effective therapies or drugs and 

21 other cancer treatments and to address those rare, 

22 deadly cancers lacking effective early detection tests 

23 or treatments for a wide range of cancers, commen24 surable with the National Cancer Institute bypass 

25 budget. 
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1 SEC. 102. SENSE OF THE HOUSE OF REPRESENTATIVES 

2 CONCERNING INVESTMENTS IN CANCER RE3 SEARCH TO DEVELOP TARGETED DRUGS. 

4 (a) FINDINGS.—The House of Representatives finds 

5 that—

6 (1) all cells have molecular signatures, unique 

7 identifiable characteristics related to a cell’s function 

8 in the body; 

9 (2) as a normal cell becomes malignant, its sig10 nature changes and this change becomes a signal of 

11 the presence of cancer; and 

12 (3) with new technologies, scientists are reading 

13 cancer-associated signatures and using this informa14 tion to devise treatments that target specific cells. 

15 (b) SENSE OF THE HOUSE OF REPRESENTATIVES.—

16 It is the sense of the House of Representatives that to 

17 build on the research currently conducted by the National 

18 Institutes of Health, increased funding is necessary to fur19 ther develop this new generation of low toxicity, high effi20 cacy agents which target only the cancer cells leaving in 

21 place the healthy cells. 

22 SEC. 103. EXPANSION OF CANCER-RELATED RESEARCH, 

23 PREVENTION, DETECTION, TREATMENT, AND 

24 SURVIVORSHIP PROGRAMS. 

25 Subpart 1 of part C of title IV of the Public Health 

26 Service Act (42 U.S.C. 285) is amended—
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1 (1) by inserting after the subpart heading the 

2 following: 

3 ‘‘CHAPTER I—PURPOSE OF INSTITUTE AND 

4 NATIONAL CANCER PROGRAMS’’; 

5 and 

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

7 ‘‘CHAPTER II—PROGRAMS TO PREVENT AND 

8 TREAT CANCER 

9 ‘‘SEC. 417E. STUDY AND STRATEGIC PLANS. 

10 ‘‘(a) IN GENERAL.—Not later than July 1, 2005, the 

11 Institute shall prepare 1 or more strategic plans to iden12 tify unmet needs and the level of funding in the areas of 

13 prevention, treatment, early detection, and quality of life, 

14 and to expand and intensify cancer research and cancer15 related research by July 1, 2006, for—

16 ‘‘(1) behavioral research associated with caus17 ing and preventing cancer; 

18 ‘‘(2) research regarding prevention of cancer 

19 other than behavioral interventions; 

20 ‘‘(3) research to reduce disparities among racial 

21 and ethnic minorities and other disparity popu22 lations; 

23 ‘‘(4) research regarding palliative care, pain 

24 management; 
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1 ‘‘(5) research regarding preserving and restor2 ing quality-of-life for cancer patients; 

3 ‘‘(6) research regarding environmental risk fac4 tors for cancer and gene-environment interactions; 

5 ‘‘(7) research regarding management of symp6 toms;

7 ‘‘(8) research regarding tools for early detec8 tion, especially for which there currently are no ade9 quate screening technologies; and 

10 ‘‘(9) cancer survivorship. 

11 ‘‘(b) PRIORITIES.—The Institute shall determine pri12 orities based on scientific opportunities, in consultation 

13 with medical, scientific, patient, and provider representa14 tives, and prepare 1 or more strategic plans by July 1, 

15 2005. 

16 ‘‘SEC. 417E–1. GRANTS FOR TRANSLATIONAL CANCER RE17 SEARCH. 

18 ‘‘(a) IN GENERAL.—The Director of the Institute 

19 shall carry out a program to establish translational cancer 

20 research centers. 

21 ‘‘(b) DUTIES OF DIRECTOR.—In carrying out the 

22 program, the Director of the Institute shall—

23 ‘‘(1) award grants to public or nonprofit private 

24 entities to plan and operate a national network of at 

25 least 20 existing or new translational cancer re-
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1 search centers to conduct translational, multidisci2 plinary cancer research; 

3 ‘‘(2) establish networks and partnerships link4 ing the translational cancer research centers de5 scribed in paragraph (1) to community cancer pro6 viders (hospitals, clinics, providers’ practices, par7 ticularly in underserved areas) and expand opportu8 nities for all cancer patients to participate in clinical 

9 trials of new agents developed by these centers; 

10 ‘‘(3) facilitate the process to award grants, con11 tracts, and cooperative agreements to private entities 

12 to conduct translational cancer research in the fol13 lowing areas—

14 ‘‘(A) cancer drugs, biologics, and devices; 

15 and 

16 ‘‘(B) cancer detection diagnostic tests, 

17 techniques, and technology; and 

18 ‘‘(4) develop and implement a strategic plan by 

19 July 1, 2005, in collaboration with translational cen20 ters as authorized in paragraph (7) for intensifying, 

21 expanding, and disseminating results of translational 

22 research to providers of cancer care. 

23 ‘‘(c) GRANTS.—

24 ‘‘(1) IN GENERAL.—The Director of the Insti25 tute shall award grants to public or nonprofit pri-
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1 vate entities to establish translational cancer re2 search centers to conduct translational, multidisci3 plinary cancer research. Funds shall not be used for 

4 construction of new facilities. 

5 ‘‘(2) EQUITY.—The Director of the Institute 

6 shall award grants under subsection (b)(1) to pro7 vide, to the greatest extent practicable, a broad dis8 tribution of such grants among geographic regions 

9 of the United States. 

10 ‘‘(3) DUTIES.—A public or nonprofit entity that 

11 receives a grant under subsection (b)(1) shall use 

12 funds received through such grant to establish and 

13 operate a translational cancer research center. 

14 ‘‘(4) APPLICATION.—A public or nonprofit enti15 ty desiring a grant under this subsection shall sub16 mit an application to the Director of the Institute at 

17 such time, in such manner, and containing such in18 formation as the Director of the Institute may rea19 sonably require. 

20 ‘‘(d) DUTIES OF TRANSLATIONAL RESEARCH CEN21 TERS.—The translational research centers shall—

22 ‘‘(1) perform research for discovery and pre23 clinical evaluation of drugs, biologics, devices, tech24 nologies, and strategies with potential to improve the 

25 prevention, detection, diagnosis, and treatment of
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1 cancer and to improve pain and symptom manage2 ment and quality of life of cancer patients; 

3 ‘‘(2) perform clinical research studies on prom4 ising cancer treatments or strategies, in appropriate 

5 human populations; 

6 ‘‘(3) evaluate promising cancer diagnostic tests, 

7 techniques, or technologies in individuals being eval8 uated for the presence of cancer; 

9 ‘‘(4) perform all phases of clinical trials of new 

10 drugs, devices, biologics, or other strategies for 

11 treating patients with cancer, in collaboration with 

12 the existing NCI Cooperative Groups; 

13 ‘‘(5) develop and implement a plan to ensure 

14 the availability of adequate sources of patients for 

15 each type of clinical research study; 

16 ‘‘(6) create systems and external relationships, 

17 which do not duplicate capabilities available in the 

18 private sector, to accelerate the findings from 

19 translational research to a stage that private compa20 nies can assume development and commercialization; 

21 and 

22 ‘‘(7) develop and implement a plan expanding 

23 and disseminating the efficacious products of 

24 translational research to providers of cancer care, in-
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1 cluding products approved by the Food and Drug 

2 Administration. 

3 ‘‘(e) DEFINITIONS.—In this section: 

4 ‘‘(1) CLINICAL TRIAL.—The term ‘clinical trial’ 

5 means a scientifically-designed clinical investigation 

6 in which a patient participates in examining the ef7 fects of a drug, biologic medical treatment, or med8 ical device for the prevention, early detection, or 

9 treatment of cancer or the potential side effects of 

10 treatment or of the disease. 

11 ‘‘(2) TRANSLATIONAL CANCER RESEARCH.—

12 The term ‘translational cancer research’ means sci13 entific laboratory and clinical research and testing 

14 needed to transform scientific discoveries into new 

15 approaches and products that can prevent, detect, 

16 control, diagnose, and treat cancer, optimize quality 

17 of life, and ultimately, cure cancer. 

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

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

20 $100,000,000 in fiscal year 2004, and $100,000,000 for 

21 each of the fiscal years 2005, 2006, 2007, and 2008. 

22 ‘‘SEC. 417E–2. GRANTS FOR DEVELOPMENT OF TARGETED 

23 DRUGS. 

24 ‘‘(a) IN GENERAL.—The Director of the Institute 

25 shall carry out a research grant program to provide fund-
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1 ing to projects that seek to develop cancer treatments that 

2 target cancer cells. 

3 ‘‘(b) DUTIES OF DIRECTOR.—In carrying out the 

4 program under subsection (a), the Director of the Insti5 tute shall—

6 ‘‘(1) award grants and facilitate the process to 

7 award grants to public or nonprofit private entities 

8 to conduct research to develop a molecularly-ori9 ented, knowledge-based approach to cancer drug dis10 covery and development; and 

11 ‘‘(2) not later than July 1, 2005, develop and 

12 implement a strategic plan for intensifying and ex13 panding research conducted to increase the number 

14 of cancer treatments available that are low toxicity, 

15 high efficacy agents, and in particular, research to 

16 develop treatments that selectively target malignant 

17 or cancerous cells. 

18 ‘‘(c) LIMITATIONS.—Amounts awarded under grants 

19 under this section shall not be used for the construction 

20 of facilities. 

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

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

23 $20,000,000 in fiscal year 2004, and $20,000,000 for 

24 each of the fiscal years 2005, 2006, 2007, and 2008. 
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1 ‘‘SEC. 417E–3. CLINICAL TRIALS. 

2 ‘‘(a) IN GENERAL.—The Director of the Institute 

3 shall carry out a program to increase patient and provider 

4 participation in clinical trials. 

5 ‘‘(b) PROGRAM.—The program described in sub6 section (a) shall include—

7 ‘‘(1) an outreach program; 

8 ‘‘(2) a diversity assurance program; 

9 ‘‘(3) an assistance program, including recom10 mending sources of funding for patients support 

11 costs; and 

12 ‘‘(4) culturally appropriate materials. 

13 ‘‘(c) OUTREACH PROGRAM.—In carrying out the out14 reach program described in subsection (a), the Director 

15 of the Institute shall regularly provide information to can16 cer care providers, professional and patient organizations, 

17 including community-based organizations, and patients to 

18 increase provider participation and patient enrollment in 

19 clinical trials. 

20 ‘‘(d) DIVERSITY ASSURANCE PROGRAM.—In carrying 

21 out the diversity assurance program described in sub22 section (a), the Director of the Institute shall require that 

23 all research grant applications include assurances that the 

24 applicant will actively recruit a diverse patient population, 

25 including disparity populations, to participate in trials, 

26 when such recruitment is medically appropriate. 
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1 ‘‘SEC. 417E–4. CANCER CARE RESEARCHERS. 

2 ‘‘(a) SUPPLY OF CANCER RESEARCHERS.—In order 

3 to ensure a sufficient number of researchers trained in the 

4 prevention, early detection, diagnosis, cure, and treatment 

5 of cancer in future fiscal years, the Director of the Insti6 tute, in coordination with the Secretary of Veterans Af7 fairs, shall carry out activities to—

8 ‘‘(1) increase the number and amount of insti9 tutional training grants to institutions supporting 

10 cancer research; and 

11 ‘‘(2) increase the number of career development 

12 awards for health professionals, particularly minori13 ties, who intend to have, or who expand, careers in 

14 basic, clinical, and translational cancer research, in15 cluding cancer prevention, cancer information tech16 nology, bioinformatics, behavioral research, and re17 search on palliative, psychosocial, and end-of-life 

18 care. 

19 ‘‘(b) LOAN REPAYMENT.—

20 ‘‘(1) ESTABLISHMENT.—The Director of the 

21 Institute, in consultation with the Director of the 

22 National Institutes of Health, shall establish a can23 cer research loan repayment program. 

24 ‘‘(2) CONTRACTS.—Under the program estab25 lished under paragraph (1), the Director of the In26 stitute shall enter into contracts with qualified
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1 health professionals under which such professionals 

2 will agree to conduct cancer research, in consider3 ation of the Federal Government agreeing to repay, 

4 for each year of such services, not more than 

5 $35,000 of the principal and interest of the edu6 cational loans of such professionals obtained to sup7 port training for degrees or licenses, as determined 

8 appropriate by the Director of the Institute. 

9 ‘‘(c) POSTDOCTORAL STIPENDS.—

10 ‘‘(1) IN GENERAL.—The Director of the Insti11 tute, shall develop and implement, for postdoctoral 

12 trainees and fellows, a stipend schedule that by Oc13 tober 1, 2004, begins for entry-level positions and 

14 individuals with no or limited experience comparable 

15 to grade 11 of the Federal general schedule under 

16 title 5, United States Code (civil service salary 

17 schedule) and that adequately reflects training, edu18 cation, experience, and comparable salaries or sti19 pends for comparable work in non-Federal settings, 

20 and provides for annual cost-of-living adjustments. 

21 ‘‘(2) AUTHORIZATION OF APPROPRIATIONS.—

22 There is authorized to be appropriated to carry out 

23 this subsection, $79,000,000 for fiscal year 2004, 

24 and $86,000,000 for fiscal year 2005, $95,000,000 
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1 for fiscal year 2006, $105,000,000 for fiscal year 

2 2007, and $115,000,000 for fiscal year 2008. 

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

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

5 $10,500,000 for fiscal year 2004, and $10,500,000 for 

6 each of fiscal years 2005 through 2008. 

7 ‘‘SEC. 417E–5. CANCER CARE WORKFORCE. 

8 ‘‘(a) IN GENERAL.—The Secretary shall establish a 

9 program to address current and future cancer care work10 force needs. 

11 ‘‘(b) PROGRAM.—The program described in sub12 section (a) shall—

13 ‘‘(1) set annual and long-term training goals to 

14 assure an adequate cancer care workforce; 

15 ‘‘(2) prepare and implement a plan to provide 

16 assistance to individuals based on cancer health pro17 fessions with the most severe shortages; 

18 ‘‘(3) award grants, scholarships, fellowships, 

19 and loans to eligible individuals to increase the can20 cer care workforce; 

21 ‘‘(4) make awards to eligible individuals to in22 crease cancer care workforce training for all individ23 uals to become cancer care providers, especially but 

24 not limited to, such individuals who make a commit25 ment to serve in underserved communities or areas 
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1 with disproportionately high cancer incidence or 

2 mortality and for health professions for which there 

3 are anticipated shortages, including providers, phar4 macists, nurses for all settings, allied health profes5 sionals, physicians, specialists, and public health 

6 professionals; and 

7 ‘‘(5) be coordinated with existing programs to 

8 prevent duplication. 

9 ‘‘(c) ELIGIBILITY.—To be eligible to receive a schol10 arship, loan, or fellowship under this section, an individual 

11 shall submit an application to the Secretary at such time, 

12 in such manner, and containing such information as the 

13 Secretary reasonably requires. In such application, such 

14 individual shall demonstrate the intent to seek training to 

15 get a certificate, license, or postsecondary degree in health 

16 care, or in the case of licensed health care professionals, 

17 the intent to seek professional development to upgrade 

18 skills and knowledge or to obtain specialized knowledge ac19 cording to criteria developed by the Secretary. 

20 ‘‘(d) USE OF FUNDS.—A recipient of a grant, schol21 arship, loan, or fellowship under this section may use 

22 funds from such grant, scholarship, loan, or fellowship to 

23 pay the costs of tuition and fees for training in—

24 ‘‘(1) care and treatment of cancer patients and 

25 survivors; 
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1 ‘‘(2) quality of life and symptom management; 

2 ‘‘(3) early detection and diagnosis; 

3 ‘‘(4) cancer prevention; 

4 ‘‘(5) genetic testing and counseling; 

5 ‘‘(6) language and cultural competency in can6 cer care; and

7 ‘‘(7) palliative and end-of-life care. 

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

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

10 $100,000,000 in fiscal year 2004 and such sums as may 

11 be necessary in each year for fiscal years 2005, 2006, 

12 2007, and 2008. 

13 ‘‘SEC. 417E–6. CENTERS FOR DISEASE CONTROL AND PRE14 VENTION. 

15 ‘‘(a) PROGRAM.—The Director of the Centers for 

16 Disease Control and Prevention shall—

17 ‘‘(1) expand and update the National Com18 prehensive Cancer Control Program; 

19 ‘‘(2) assist States, territories, tribal organiza20 tions, and the District of Columbia in developing 

21 and implementing a cancer prevention and control 

22 program so that each entity will have an active plan 

23 in place and so that States, territories, tribal organi24 zations, and the District of Columbia will conduct 
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1 activities to prevent and control cancer and so that 

2 disparities in specific populations will be addressed; 

3 ‘‘(3) establish programs that demonstrate how 

4 to prevent and control cancer and improve access to 

5 and the quality of cancer care among racial and eth6 nic minority and medically underserved populations 

7 with disproportionate incidence of or death from 

8 cancer; 

9 ‘‘(4) promote cancer education, prevention, and 

10 early detection of cancer; and 

11 ‘‘(5) award grants to public and nonprofit orga12 nizations for cancer control and prevention. 

13 ‘‘(b) AUTHORIZATION OF APPROPRIATIONS.—There 

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

15 $65,000,000 for fiscal year 2004 and such sums as may 

16 be necessary for fiscal years 2005, 2006, 2007, and 2008. 

17 ‘‘SEC. 417E–7. CANCER SURVIVORSHIP. 

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

19 the Director of the Centers for Disease Control and Pre20 vention, shall conduct a study of the unique health chal21 lenges associated with cancer survivorship and carry out 

22 projects and interventions to improve the long-term health 

23 status of cancer survivors. Such projects shall be carried 

24 out directly or through the awarding of grants or con25 tracts.
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1 ‘‘(b) ACTIVITIES.—Activities that may be carried out 

2 under subsection (a) include—

3 ‘‘(1) the expansion of current cancer surveil4 lance systems to track the health status of cancer 

5 survivors and determine whether cancer survivors 

6 are at-risk for other chronic and disabling condi7 tions; 

8 ‘‘(2) assess the unique challenges associated 

9 with cancer survivorship; and 

10 ‘‘(3) the development of a national cancer survi11 vorship action plan, in partnership with health orga12 nizations focused on cancer survivorship, to be car13 ried out in coordination with the State-based com14 prehensive cancer control program of the Centers for 

15 Disease Control and Prevention to—

16 ‘‘(A) develop unique and innovative post17 treatment programs, services, and demonstra18 tions designed to support and advance cancer 

19 survivorship through—

20 ‘‘(i) promotion of physical activity and 

21 healthy lifestyles; 

22 ‘‘(ii) educational outreach programs 

23 for health care providers; 
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1 ‘‘(iii) support for innovative programs 

2 to improve the quality of life among cancer 

3 survivors; 

4 ‘‘(iv) home and community-based 

5 interventions; 

6 ‘‘(v) peer support and mentor pro7 grams;

8 ‘‘(vi) public awareness and outreach 

9 campaigns; and 

10 ‘‘(vii) information dissemination to in11 form health care providers and cancer sur12 vivors of their health care options and 

13 available survivorship programs; and 

14 ‘‘(B) develop unique cancer survivorship 

15 demonstration programs designed to address 

16 the needs of underserved populations, including 

17 minorities, children, and individuals residing in 

18 rural areas. 

19 ‘‘(c) COORDINATION OF ACTIVITIES.—The Secretary 

20 shall ensure that activities carried out under this section 

21 are coordinated as appropriate with other agencies of the 

22 Public Health Service. 

23 ‘‘(d) REPORT TO CONGRESS.—Not later than Octo24 ber 1, 2004, the Secretary shall submit to Congress a re25 port describing the results of the study conducted under 
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1 subsection (a), and as applicable, the strategies developed 

2 under such subsection. 

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

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

5 $35,000,000 for fiscal year 2004, and such sums as may 

6 be necessary for each of fiscal years 2005 through 2008. 

7 ‘‘SEC. 417E–8. OFFICE OF CANCER SURVIVORSHIP. 

8 ‘‘(a) ESTABLISHMENT.—There is established within 

9 the Institute an Office on Cancer Survivorship (in this sec10 tion referred to as the ‘Office’), to be headed by an Asso11 ciate Director, to implement and direct the expansion and 

12 coordination of the activities of the Institute with respect 

13 to cancer survivorship research. 

14 ‘‘(b) COLLABORATION AMONG AGENCIES.—In car15 rying out the activities described in subsection (a), the Of16 fice shall collaborate with other institutes, centers, and of17 fices within the National Institutes of Health that are de18 termined appropriate by the Office. 

19 ‘‘(c) REPORT.—Not later than 1 year after the date 

20 of enactment of this section, the Secretary shall prepare 

21 and submit to the appropriate committees of Congress a 

22 report providing a description of the survivorship activities 

23 of the Office and strategies for future activities. 

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

25 are authorized to be appropriated to carry out this section, 
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1 such sums as may be necessary for each of fiscal years 

2 2004 through 2008. 

3 ‘‘SEC. 417E–9. MONITORING AND EVALUATING QUALITY 

4 CANCER CARE AND CANCER SURVIVORSHIP. 

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

6 the Director of the Institute and the Director of the Cen7 ters for Disease Control and Prevention, shall make grants 

8 to eligible entities for the purpose of enabling such entities 

9 to monitor and evaluate quality cancer care, develop infor10 mation concerning quality cancer care, and monitor cancer 

11 survivorship. 

12 ‘‘(b) ELIGIBLE ENTITIES.—An entity shall be eligible 

13 for a grant under this section for a fiscal year if such enti14 ty—

15 ‘‘(1) operates a statewide cancer registry with 

16 funds from a grant made under section 399B for 

17 such fiscal year; and 

18 ‘‘(2) is certified by the North American Asso19 ciation of Central Cancer Registries or another simi20 lar certification organization. 

21 ‘‘(c) CONTRACTING AUTHORITY.—In carrying the 

22 purpose described in subsection (a), an eligible entity may 

23 expend a grant under such subsection to enter into con24 tracts with academic institutions, cancer centers, and 
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1 other entities, when determined appropriate by the Sec2 retary. 

3 ‘‘(d) APPLICATION.—To be eligible for a grant under 

4 subsection (a), an eligible entity shall submit to the Sec5 retary an application at such time, in such manner, and 

6 containing such agreements, assurances, and information 

7 as the Secretary determines to be necessary to carry out 

8 this section. 

9 ‘‘(e) AUTHORITY OF SECRETARY REGARDING USE OF

10 GRANT FUNDS.—The Secretary shall determine the ap11 propriate uses of grant funds under subsection (a) to 

12 achieve the purpose described in such subsection. 

13 ‘‘(f) AUTHORIZATION OF APPROPRIATIONS.—For the 

14 purpose of carrying out this section, there are authorized 

15 to be appropriated such sums as may be necessary for 

16 each of fiscal years 2004 through 2008. 

17 ‘‘SEC. 417E–10. MODEL COMMUNITY CANCER AND CHRONIC 

18 DISEASE CARE AND PREVENTION; PATIENT 

19 NAVIGATORS. 

20 ‘‘(a) DEFINITIONS.—In this section: 

21 ‘‘(1) APPROPRIATE FOLLOW-UP CARE.—The 

22 term ‘appropriate follow-up care’ includes palliative 

23 and end-of-life care. 

24 ‘‘(2) CULTURALLY COMPETENT.—The term 

25 ‘culturally competent’, with respect to providing
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1 health-related services, means services that, in ac2 cordance with standards and measures of the Sec3 retary, are designed to effectively and efficiently re4 spond to the cultural and linguistic needs of pa5 tients. 

6 ‘‘(3) ELIGIBLE ENTITY.—The term ‘eligible en7 tity’ means any public or private entity determined 

8 to be appropriate by the Director of the Institute 

9 that provides services described in subsection 

10 (b)(1)(A) for cancer and chronic diseases, or any of 

11 the following entities that demonstrates the ability to 

12 perform all of the functions outlined in subsections 

13 (b) through (d): 

14 ‘‘(A) A designated cancer center of the In15 stitute. 

16 ‘‘(B) An academic institution. 

17 ‘‘(C) An Indian Health Service Clinic. 

18 ‘‘(D) A tribal government. 

19 ‘‘(E) An urban Indian organization. 

20 ‘‘(F) A tribal organization. 

21 ‘‘(G) A hospital. 

22 ‘‘(H) A qualified nonprofit entity that 

23 partners with 1 or more centers providing 

24 health care to provide navigation services. 
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1 ‘‘(4) HEALTH DISPARITY POPULATION.—The 

2 term ‘health disparity population’ means a popu3 lation where there exists a significant disparity in 

4 the overall rate of disease incidence, morbidity, mor5 tality, or survival rates in the population as com6 pared to the health status of the general population. 

7 Such term includes—

8 ‘‘(A) racial and ethnic minority groups (as 

9 defined under section 1707); and

10 ‘‘(B) medically underserved groups, such 

11 as rural and low-income individuals and individ12 uals with low levels of literacy. 

13 ‘‘(5) PATIENT NAVIGATOR.—

14 ‘‘(A) IN GENERAL.—The term ‘patient 

15 navigator’ means an individual whose functions 

16 include—

17 ‘‘(i) assisting and guiding patients 

18 with a symptom, abnormal finding, or di19 agnosis of cancer or other chronic disease 

20 within the health care system to accom21 plish the follow-up and diagnosis of an ab22 normal finding as well as the treatment 

23 and appropriate follow-up care of cancer or 

24 other chronic disease, including providing 

25 information about clinical trials; and 
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1 ‘‘(ii) identifying, anticipating, and 

2 helping patients overcome barriers within 

3 the health care system to ensure prompt 

4 diagnostic and treatment resolution of an 

5 abnormal finding of cancer or other chron6 ic disease. 

7 ‘‘(B) INCLUSIONS.—The term ‘patient nav8 igator’ includes representatives of the target 

9 health disparity population, such as nurses, so10 cial workers, cancer survivors, and patient ad11 vocates. 

12 ‘‘(b) MODEL COMMUNITY CANCER AND CHRONIC

13 DISEASE CARE AND PREVENTION.—

14 ‘‘(1) IN GENERAL.—The Director of the Insti15 tute may make grants to eligible entities for the de16 velopment and operation of model programs that—

17 ‘‘(A) provide to individuals of health dis18 parity populations prevention, early detection, 

19 treatment, and appropriate follow-up care serv20 ices for cancer and chronic diseases; 

21 ‘‘(B) ensure that the health services are 

22 provided to such individuals in a culturally com23 petent manner; 

24 ‘‘(C) assign patient navigators, in accord25 ance with applicable criteria of the Secretary, 
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1 for managing the care of individuals of health 

2 disparity populations to—

3 ‘‘(i) accomplish, to the extent possible, 

4 the follow-up and diagnosis of an abnormal 

5 finding and the treatment and appropriate 

6 follow-up care of cancer or other chronic 

7 disease; and 

8 ‘‘(ii) facilitate access to appropriate 

9 health care services within the health care 

10 system to ensure optimal patient utiliza11 tion of such services, including aid in co12 ordinating and scheduling appointments 

13 and referrals, community outreach, assist14 ance with transportation arrangements, 

15 and assistance with insurance issues and 

16 other barriers to care and providing infor17 mation about clinical trials; 

18 ‘‘(D) require training for patient naviga19 tors employed through such model programs to 

20 ensure the ability of navigators to perform all 

21 of the duties required in this subsection and in 

22 subsection (c), including training to ensure that 

23 navigators are informed about health insurance 

24 systems and are able to aid patients in resolv25 ing access issues; and
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1 ‘‘(E) ensure that consumers have direct ac2 cess to patient navigators during regularly 

3 scheduled hours of business operation. 

4 ‘‘(2) APPLICATION FOR GRANT.—An eligible en5 tity that desires to receive a grant under paragraph 

6 (1) shall submit an application to the Director of the 

7 Institute at such time, in such manner, and con8 taining such agreements, assurances, and informa9 tion as the Director of the Institute determines to be 

10 necessary to carry out this section. 

11 ‘‘(3) OUTREACH SERVICES.—In order to be eli12 gible to receive a grant under paragraph (1), an eli13 gible entity shall agree to provide ongoing outreach 

14 activities while receiving the grant, in a manner that 

15 is culturally competent for the health disparity popu16 lation served by the program, to inform the public 

17 and the specific community that the program is 

18 serving of the services of the model program under 

19 the grant. Such activities shall include facilitating 

20 access to appropriate health care services and pa21 tient navigators within the health care system to en22 sure optimal patient utilization of such services. 

23 ‘‘(4) DATA COLLECTION AND REPORT.—In 

24 order to allow for effective program evaluation, an 

25 eligible entity that receives a grant under this sub-
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1 section shall collect specific patient data recording 

2 services provided to each patient served by the pro3 gram and shall establish and implement procedures 

4 and protocols, consistent with applicable Federal and 

5 State laws (including sections 160 and 164 of title 

6 45, Code of Federal Regulations) to ensure the con7 fidentiality of all information shared by a participant 

8 in the program, or their personal representative and 

9 their health care providers, group health plans, or 

10 health insurance insurers with the program. The 

11 program may, consistent with applicable Federal and 

12 State confidentiality laws, collect, use, or disclose ag13 gregate information that is not individually identifi14 able (as defined in sections 160 and 164 of title 45, 

15 Code of Federal Regulations). With this data, the 

16 grantee shall submit an annual report to the Sec17 retary that summarizes and analyzes the data and 

18 provides information on needs for navigation serv19 ices, types of access difficulties resolved, sources of 

20 repeated resolution, and flaws in the system of ac21 cess, including insurance barriers. 

22 ‘‘(5) EVALUATIONS.—

23 ‘‘(A) IN GENERAL.—The Director of the 

24 Institute, directly or through grants or con25 tracts, shall provide for evaluations to deter-
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•HR 2741 IH 

1 mine which outreach activities under paragraph 

2 (3) were most effective in informing the public 

3 and the specific community that the program is 

4 serving of the model program services and to 

5 determine the extent to which such programs 

6 were effective in providing culturally competent 

7 services to the health disparity population 

8 served by the programs.

9 ‘‘(B) DISSEMINATION OF FINDINGS.—The 

10 Director of the Institute shall, as appropriate, 

11 disseminate to public and private entities the 

12 findings made in evaluations under subpara13 graph (A). 

14 ‘‘(6) COORDINATION WITH OTHER PRO15 GRAMS.—The Secretary shall coordinate the pro16 gram under this subsection with—

17 ‘‘(A) the program under subsection (c); 

18 ‘‘(B) the program under section 330M; 

19 and 

20 ‘‘(C) to the extent practicable, programs 

21 for prevention centers that are carried out by 

22 the Director of the Centers for Disease Control 

23 and Prevention. 

24 ‘‘(c) PROGRAM FOR PATIENT NAVIGATORS.—
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1 ‘‘(1) IN GENERAL.—The Director of the Insti2 tute may make grants to eligible entities for the de3 velopment and operation of programs to pay the 

4 costs of such entities in—

5 ‘‘(A) assigning patient navigators, in ac6 cordance with applicable criteria of the Sec7 retary, for managing the care of individuals of 

8 health disparity populations for the duration of 

9 receipt of health services from the health cen10 ters, including aid in coordinating and sched11 uling appointments and referrals, community 

12 outreach, assistance with transportation ar13 rangements, assistance with insurance issues 

14 and other barriers to care, and providing infor15 mation about clinical trials; 

16 ‘‘(B) ensuring that the services provided by 

17 the patient navigators to such individuals in18 clude case management and psychosocial as19 sessment and care or information and referral 

20 to such services; 

21 ‘‘(C) ensuring that the patient navigators 

22 with direct knowledge of the communities they 

23 serve provide services to such individuals in a 

24 culturally competent manner; 
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•HR 2741 IH 

1 ‘‘(D) developing model practices for patient 

2 navigators, including with respect to—

3 ‘‘(i) coordination of health services, 

4 including psychosocial assessment and 

5 care; 

6 ‘‘(ii) follow-up services, including psy7 chosocial assessment and care; 

8 ‘‘(iii) determining coverage under 

9 health insurance and health plans for all 

10 services; 

11 ‘‘(iv) ensuring the initiation, continu12 ation, or sustained access to care pre13 scribed by the patients’ health care pro14 viders; and 

15 ‘‘(v) aiding patients with health insur16 ance coverage issues; 

17 ‘‘(E) requiring training for patient naviga18 tors to ensure the ability of navigators to per19 form all of the duties required in this sub20 section and in subsection (b), including train21 ing, to ensure that navigators are informed 

22 about health insurance systems and are able to 

23 aid patients in resolving access issues; and
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•HR 2741 IH 

1 ‘‘(F) ensuring that consumers have direct 

2 access to patient navigators during regularly 

3 scheduled hours of business operation. 

4 ‘‘(2) APPLICATION FOR GRANT.—An eligible en5 tity that desires to receive a grant under paragraph 

6 (1) shall submit an application to the Director of the 

7 Institute at such time, in such manner, and con8 taining such agreements, assurances, and informa9 tion as the Director of the Institute determines to be 

10 necessary to carry out this section. 

11 ‘‘(3) OUTREACH SERVICES.—In order to be eli12 gible to receive a grant under paragraph (1), an eli13 gible entity shall agree to provide ongoing outreach 

14 activities while receiving the grant, in a manner that 

15 is culturally competent for the health disparity popu16 lation served by the program, to inform the public 

17 and the specific community that the patient navi18 gator is serving of the services of the model program 

19 under the grant. 

20 ‘‘(4) DATA COLLECTION AND REPORT.—In 

21 order to allow for effective patient navigator pro22 gram evaluation, an eligible entity that receives a 

23 grant under this subsection shall collect specific pa24 tient data recording navigation services provided to 

25 each patient served by the program and shall estab-
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1 lish and implement procedures and protocols, con2 sistent with applicable Federal and State laws (in3 cluding sections 160 and 164 of title 45, Code of 

4 Federal Regulations) to ensure the confidentiality of 

5 all information shared by a participant in the pro6 gram, or their personal representative and their 

7 health care providers, group health plans, or health 

8 insurance insurers with the program. The patient 

9 navigator program may, consistent with applicable 

10 Federal and State confidentiality laws, collect, use, 

11 or disclose aggregate information that is not individ12 ually identifiable (as defined in sections 160 and 164 

13 of title 45, Code of Federal Regulations). With this 

14 data, the grantee shall submit an annual report to 

15 the Secretary that summarizes and analyzes the 

16 data and provides information on needs for naviga17 tion services, types of access difficulties resolved, 

18 sources of repeated resolution, and flaws in the sys19 tem of access, including insurance barriers. 

20 ‘‘(5) EVALUATIONS.—

21 ‘‘(A) IN GENERAL.—The Director of the 

22 Institute, directly or through grants or con23 tracts, shall provide for evaluations to deter24 mine the effects of the services of patient navi25 gators on the health disparity population for 
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1 whom the services were provided, taking into 

2 account the matters referred to in paragraph 

3 (1)(C). 

4 ‘‘(B) DISSEMINATION OF FINDINGS.—The 

5 Director of the Institute shall as appropriate 

6 disseminate to public and private entities the 

7 findings made in evaluations under subpara8 graph (A). 

9 ‘‘(6) COORDINATION WITH OTHER PRO10 GRAMS.—The Secretary shall coordinate the pro11 gram under this subsection with the programs under 

12 subsection (b) and section 330M.

13 ‘‘(d) REQUIREMENTS REGARDING FEES.—

14 ‘‘(1) IN GENERAL.—In order to be eligible to 

15 receive a grant under subsection (b) or (c), the pro16 gram for which the grant is made shall have in ef17 fect—

18 ‘‘(A) a schedule of fees or payments for 

19 the provision of such program’s health care 

20 services related to the prevention and treatment 

21 of disease that is consistent with locally pre22 vailing rates or charges and is designed to cover 

23 such program’s reasonable costs of operation; 

24 and 
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1 ‘‘(B) a corresponding schedule of discounts 

2 to be applied to the payment of such fees or 

3 payments, which discounts are adjusted on the 

4 basis of the ability of the patient to pay. 

5 ‘‘(2) RULE OF CONSTRUCTION.—Nothing in 

6 this subsection shall be construed to require pay7 ment for navigation services or to require payment 

8 for health care services in cases where care is pro9 vided free of charge, including the case of services 

10 provided through programs of the Indian Health 

11 Service. 

12 ‘‘(e) MODEL.—Not later than 5 years after the date 

13 of enactment of this section, the Director of the Institute 

14 shall develop a peer-reviewed model of systems for the 

15 services provided by this section. The Director of the Insti16 tute shall update such model as may be necessary to en17 sure that the best practices are being utilized. 

18 ‘‘(f) DURATION OF GRANT.—The period during 

19 which payments are made to an eligible entity from a 

20 grant under subsection (b)(1) or (c)(1) may not exceed 

21 5 years. The provision of such payments are subject to 

22 annual approval by the Director of the Institute and sub23 ject to the availability of appropriations for the fiscal year 

24 involved. Nothing in this subsection shall be construed as 

25 establishing a limitation on the number of grants under 
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1 subsections (b) and (c) that may be made to an eligible 

2 entity. 

3 ‘‘(g) AUTHORIZATION OF APPROPRIATIONS.—

4 ‘‘(1) MODEL PROGRAMS.—For the purpose of 

5 carrying out subsection (b), there are authorized to 

6 be appropriated such sums as may be necessary for 

7 each of the fiscal years 2004 through 2008. 

8 ‘‘(2) PATIENT NAVIGATORS.—For the purpose 

9 of carrying out subsection (c), there are authorized 

10 to be appropriated such sums as may be necessary 

11 for each of the fiscal years 2004 through 2008. 

12 ‘‘(3) RELATION TO OTHER AUTHORIZATIONS.—

13 Authorizations of appropriations under paragraphs 

14 (1) and (2) are in addition to other authorizations 

15 of appropriations that are available for the purposes 

16 of carrying out subsections (b) and (c). 

17 ‘‘SEC. 417E–11. CANCER CARE GUIDELINES. 

18 ‘‘The Agency for Healthcare Research and Quality 

19 shall regularly convene cancer experts, providers, patients, 

20 representatives of disparity populations, and other rel21 evant experts, including representatives of the Institute, 

22 the Health Resources Administration, and the Centers for 

23 Disease Control and Prevention, to coordinate the develop24 ment and regularly update—
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•HR 2741 IH 

1 ‘‘(1) consensus protocols and practice guidelines 

2 for optimal cancer treatments and prevention, in3 cluding palliation, symptom management, and end4 of-life care; 

5 ‘‘(2) quality of care measures to assist providers 

6 and patients in making and evaluating treatment de7 cisions; and 

8 ‘‘(3) guidelines for providing patients with 

9 multi-disciplinary consultation before treatment is 

10 initiated and with 1 physician, preferably a specialist 

11 when feasible, to provide overall coordination and 

12 management of cancer care among all providers of 

13 the patient’s treatment and services. 

14 ‘‘SEC. 417E–12. RESEARCH AND OTHER ACTIVITIES OF THE 

15 AGENCY FOR HEALTHCARE RESEARCH AND 

16 QUALITY TO IMPROVE THE QUALITY AND 

17 OUTCOMES OF CANCER CARE. 

18 ‘‘(a) IN GENERAL.—

19 ‘‘(1) RESEARCH.—The Director for Healthcare 

20 Research and Quality shall conduct and support re21 search and other activities to build an evidence base 

22 regarding effective clinical and organizational inter23 vention strategies to improve the quality and out24 comes of cancer care, and access to such care, at all 

25 stages of the health care continuum and to facilitate 
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1 the prompt use of that information to improve prac2 tice. 

3 ‘‘(2) FACTORS.—In carrying out paragraph (1), 

4 the Director for Healthcare Research and Quality 

5 shall take into account the breadth of the continuum 

6 of cancer care, from prevention and early detection, 

7 through diagnosis and treatment, to rehabilitation, 

8 long term survivorship and remission, through psy9 chosocial, palliative, and end-of-life care. 

10 ‘‘(b) SPECIFIC REQUIREMENTS.—The Agency for 

11 Healthcare Research and Quality shall—

12 ‘‘(1) conduct and support research to develop 

13 new scientific knowledge regarding the effectiveness 

14 and cost-effectiveness of interventions that improve 

15 the quality and outcomes of cancer care, and access 

16 to such care; 

17 ‘‘(2) regularly assess and synthesize existing 

18 scientific evidence on the effectiveness of such inter19 ventions; 

20 ‘‘(3) ensure the targeted dissemination of the 

21 most current scientific evidence in appropriate for22 mats for use by professional societies and organiza23 tions representing clinicians and other caregivers, or24 ganizations through which health care and support 
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1 services are delivered, and organizations rep2 resenting cancer patients and their families; 

3 ‘‘(4) facilitate, as appropriate, the prompt use 

4 of existing scientific information by the professional 

5 societies and organization listed in paragraph (3) to 

6 develop guidance, best practices, quality improve7 ment strategies or other initiatives to improve prac8 tice; 

9 ‘‘(5) develop quality of care measures to assist 

10 clinicians and other caregivers, providers and health 

11 plans, patients and their families, and purchasers;

12 ‘‘(6) collect information, as appropriate, and 

13 conduct and support research on trends in medical 

14 care practice patterns and the relationship of such

15 trends to the quality and outcomes of cancer care; 

16 and 

17 ‘‘(7) assess effective strategies by which an in18 dividual physician can provide overall coordination 

19 and management of cancer care. 

20 ‘‘(c) COORDINATION OF FEDERAL QUALITY IM21 PROVEMENT ACTIVITIES AND REPORTING OF DATA.—In 

22 carrying out subsection (b)—

23 ‘‘(1) the Director for Healthcare Research and 

24 Quality, working through the Quality Interagency 

25 Coordination (QUIC) Task Force, and in collabora-
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1 tion with the Director of the Institute, shall facili2 tate coordination of Federal research and implemen3 tation initiatives to improve the quality and out4 comes of cancer care; 

5 ‘‘(2) the Agency for Healthcare Research and 

6 Quality shall serve as a resource for other Federal 

7 agencies in the measurement of the quality of cancer 

8 care; 

9 ‘‘(3) the Director for Healthcare Research and 

10 Quality and the Director of the Institute shall work 

11 cooperatively to develop data in order to set bench12 marks for, and subsequently measure changes in the 

13 quality of cancer care for inclusion, as soon as prac14 ticable, in the annual report required by section 

15 913(b)(2); and 

16 ‘‘(4) the Director for Healthcare Research and 

17 Quality shall ensure coordination of these activities, 

18 as appropriate, with his responsibilities for research 

19 on health disparities under section 903. 

20 ‘‘(d) 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 2004 through 2008. 
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1 ‘‘SEC. 417E–13. INSTITUTE OF MEDICINE STUDY ON CAN2 CER. 

3 ‘‘(a) INSTITUTE OF MEDICINE STUDY.—The Sec4 retary shall request the Institute of Medicine of the Na5 tional Academies of Sciences to initiate a study by Janu6 ary 1, 2004, of the feasibility and costs of providing medi7 care coverage under title XVIII of the Social Security Act 

8 to individuals who are diagnosed with cancer and cancer 

9 survivors through 5 years of remission of cancer at any 

10 age and who have no other means of purchasing health 

11 care or health insurance, as determined under criteria es12 tablished by the Secretary. 

13 ‘‘(b) CONTENT.—

14 ‘‘(1) IN GENERAL.—The study under subsection 

15 (a) shall be conducted in 2 parts. 

16 ‘‘(2) FIRST PART.—The first part shall—

17 ‘‘(A) examine options for providing medi18 care coverage to such individuals; 

19 ‘‘(B) estimate the cost to the medicare pro20 gram and to current and future beneficiaries; 

21 and 

22 ‘‘(C) identify advantages associated with 

23 medicare coverage in terms of access to cancer 

24 care, improved quality of care and patient out25 comes and assess the feasibility of providing 

26 medicare coverage to uninsured cancer patients
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1 through 5 years of remission and make a rec2 ommendation to Congress about whether medi3 care should be expanded to this population 

4 group. 

5 ‘‘(3) SECOND PART.—The second part shall—

6 ‘‘(A) identify changes in medicare benefits 

7 to facilitate the provision of care consistent with 

8 quality cancer care standards, including pre9 scription drug benefits and benefits to improve 

10 home care, symptom management, psychosocial 

11 services, and palliative and hospice care; 

12 ‘‘(B) estimate the cost to the medicare pro13 gram and to beneficiaries; and 

14 ‘‘(C) assess the medical advantages and 

15 disadvantages associated with expanding bene16 fits. 

17 ‘‘(4) DEADLINES.—The first part shall be com18 pleted by June 30, 2005, and the second part shall 

19 be completed by December 31, 2005. 

20 ‘‘(c) AUTHORIZATION OF APPROPRIATIONS.—There 

21 are authorized to be appropriated to carry out this section 

22 $1,000,000 in fiscal year 2004 and $1,200,000 in fiscal 

23 year 2005.’’. 
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1 SEC. 104. NATIONAL INSTITUTE FOR ENVIRONMENTAL 

2 HEALTH SCIENCES. 

3 (a) IN GENERAL.—Not later than October 1, 2004, 

4 the Director of the National Institute for Environmental 

5 Health Sciences shall, in coordination with the National 

6 Cancer Institute, prepare and submit to the Secretary of 

7 Health and Human Services a strategic plan that identi8 fies the unmet needs regarding research on environmental 

9 risk factors for cancer and gene-environment interactions 

10 and describes how to increase the amount of such research 

11 and resources for such research. 

12 (b) AUTHORIZATION OF APPROPRIATIONS.—There is 

13 authorized to be appropriated to carry out this section 

14 such sums as may be necessary. 

15 SEC. 105. COMPREHENSIVE CANCER CONTROL PLANS. 

16 Section 412 of the Public Health Service Act (42 

17 U.S.C. 285a–1) is amended—

18 (1) in the first sentence, by inserting ‘‘, for sur19 vivorship,’’ after ‘‘treatment of cancer’’; 

20 (2) in paragraph (1)(B), by striking ‘‘cancer 

21 patients’’ and all that follows and inserting the fol22 lowing: ‘‘cancer patients, families of cancer patients, 

23 and cancer survivors, and’’; and 

24 (3) in paragraph (3), by inserting ‘‘and con25 cerning cancer survivorship programs,’’ after ‘‘con26 trol of cancer’’. 
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1 SEC. 106. BREAST, CERVICAL, AND COLORECTAL CANCER 

2 SCREENING. 

3 (a) BREAST AND CERVICAL CANCER.—Section 

4 1510(a) of the Public Health Service Act (42 U.S.C. 

5 300n–5(a)) is amended by striking ‘‘$50,000,000’’ and all 

6 that follows through the period, and inserting 

7 ‘‘$250,000,000 for fiscal year 2004, and such sums as 

8 may be necessary for fiscal years 2005 through 2008.’’. 

9 (b) COLORECTAL CANCER.—Title XV of the Public 

10 Health Service Act (42 U.S.C. 300k et seq.) is amended 

11 by adding at the end the following:

12 ‘‘SEC. 1511. COLORECTAL CANCER SCREENING DEM13 ONSTRATION PROJECT. 

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

15 the Director of the Centers for Disease Control and Pre16 vention, shall award competitive grants to public and non17 profit private entities to enable such entities to establish 

18 demonstration programs pursuant to the general authority 

19 of title III to carry out colorectal screening activities in20 cluding—

21 ‘‘(1) screening asymptomatic individuals for 

22 colorectal cancer as a preventive health measure ac23 cording to scientific evidence-based screening guide24 lines; 

25 ‘‘(2) providing appropriate referrals for medical 

26 treatment of individuals screened pursuant to this 
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1 section and to ensure, to the extent practicable, the 

2 provision of appropriate follow-up services and sup3 port services such as case management; 

4 ‘‘(3) activities to improve the education, train5 ing, and skills of health professionals (including al6 lied health professionals) in the detection and con7 trol of colorectal cancer; 

8 ‘‘(4) activities to evaluate the programs under 

9 this section through appropriate surveillance or pro10 gram monitoring activities; 

11 ‘‘(5) the development and dissemination of find12 ings derived through such evaluations through public 

13 and professional education; and 

14 ‘‘(6) activities to promote the benefits of 

15 colorectal cancer screening. 

16 ‘‘(b) PAYMENTS FOR SCREENINGS.—The amount 

17 paid by a grantee under this section to an entity on behalf 

18 of an individual for the furnishing of services to such indi19 vidual shall not exceed the amount that would be paid 

20 under part B of title XVIII of the Social Security Act for 

21 such services if such payment were made under such part 

22 for such services. 

23 ‘‘(c) REQUIREMENTS.—

24 ‘‘(1) PRIORITY.—To be eligible for a grant 

25 under subsection (a), an entity shall agree to give 
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1 priority with respect to activities and services under 

2 the grant to a low-income—

3 ‘‘(A) individual who is at least 50 years of 

4 age; or 

5 ‘‘(B) individual at high risk for colorectal 

6 cancer (as defined in section 1861(pp)(2) of the 

7 Social Security Act (42 U.S.C. 1395x(pp)(2))). 

8 ‘‘(2) RELATIONSHIP TO ITEMS AND SERVICES

9 UNDER OTHER PROGRAMS.—To be eligible for a 

10 grant under subsection (a), an entity shall agree 

11 that grant funds will not be expended to make pay12 ments for any item or service to the extent that pay13 ment has been made, or can reasonably be expected 

14 to be made, with respect to such item or service—

15 ‘‘(A) under any State compensation pro16 gram, under an insurance policy, or under any 

17 Federal or State health benefits program; or 

18 ‘‘(B) by an entity that provides health 

19 service on a prepaid basis. 

20 ‘‘(3) RESTRICTIONS ON USE OF GRANT.—To be 

21 eligible for a grant under subsection (a), an entity 

22 shall agree that grant funds will not be expended to 

23 provide inpatient hospital services for an individual.
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1 ‘‘(4) RECORDS AND AUDITS.—To be eligible for 

2 a grant under subsection (a), an entity shall agree 

3 that the entity will—

4 ‘‘(A) establish such fiscal control and fund 

5 accounting procedures as may be necessary to 

6 ensure proper disbursal of, and accounting for, 

7 amounts received under this section; and 

8 ‘‘(B) provide agreed upon annual reports 

9 to the Secretary or the Comptroller of the 

10 United States for the purposes of auditing the 

11 expenditures by the entity. 

12 ‘‘(5) REPORTS.—To be eligible for a grant 

13 under subsection (a), an entity shall agree to submit 

14 to the Secretary such reports as the Secretary deter15 mines appropriate. 

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

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

18 $50,000,000 for fiscal year 2004, and such sums as may 

19 be necessary for each of fiscal years 2005 through 2008.’’. 

20 SEC. 107. IHS GRANTS FOR MODEL COMMUNITY CANCER 

21 AND CHRONIC DISEASE CARE AND PREVEN22 TION; IHS GRANTS FOR PATIENT NAVIGA23 TORS. 

24 (a) DEFINITIONS.—In this section: 
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1 (1) IN GENERAL.—The terms ‘‘culturally com2 petent’’, ‘‘appropriate follow-up care’’, ‘‘health dis3 parity population’’, and ‘‘patient navigator’’ have the 

4 meanings given those terms in section 417E–10 of 

5 the Public Health Service Act. 

6 (2) SECRETARY.—The term ‘‘Secretary’’ means 

7 the Secretary of Health and Human Services. 

8 (b) MODEL COMMUNITY CANCER AND CHRONIC DIS9 EASE CARE AND PREVENTION.—

10 (1) IN GENERAL.—The Director of the Indian 

11 Health Service may make grants, for the develop12 ment and operation of model programs that perform 

13 the same functions outlined in section 417E–

14 10(b)(1) of the Public Health Service Act, to Indian 

15 Health Service Centers, tribal governments, urban 

16 Indian organizations, tribal organizations, and quali17 fied nonprofit entities demonstrating the ability to 

18 perform all of the functions in this subsection and 

19 subsections (c) and (d) that partner with providers 

20 or centers providing health care services to Native 

21 American populations to provide navigation services. 

22 (2) APPLICATION FOR GRANT.—An entity that 

23 desires to receive a grant under paragraph (1) shall 

24 submit an application to the Secretary at such time, 

25 in such manner, and containing such agreements, 
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•HR 2741 IH 

1 assurances, and information as the Secretary deter2 mines to be necessary to carry out this section. 

3 (3) OUTREACH SERVICES.—In order to be eligi4 ble to receive a grant under paragraph (1), an entity 

5 shall agree to provide ongoing outreach activities 

6 while receiving the grant, in a manner that is cul7 turally competent for the health disparity population 

8 served by the program, to inform the public and the 

9 specific community that the program is serving of 

10 the services of the model program under the grant. 

11 Such activities shall include facilitating access to ap12 propriate health care services and patient navigators

13 within the health care system to ensure optimal pa14 tient utilization of such services. 

15 (4) DATA COLLECTION AND REPORT.—In order 

16 to allow for effective program evaluation, an entity 

17 that receives a grant under this subsection shall col18 lect specific patient data recording services provided 

19 to each patient served by the program and shall es20 tablish and implement procedures and protocols, 

21 consistent with applicable Federal and State laws 

22 (including sections 160 and 164 of title 45, Code of 

23 Federal Regulations) to ensure the confidentiality of 

24 all information shared by a participant in the pro25 gram, or their personal representative and their 
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•HR 2741 IH 

1 health care providers, group health plans, or health 

2 insurance insurers with the program. The program 

3 may, consistent with applicable Federal and State 

4 confidentiality laws, collect, use, or disclose aggre5 gate information that is not individually identifiable 

6 (as defined in sections 160 and 164 of title 45, Code 

7 of Federal Regulations). With this data, the grantee 

8 shall submit an annual report to the Secretary that 

9 summarizes and analyzes the data and provides in10 formation on needs for navigation services, types of 

11 access difficulties resolved, sources of repeated reso12 lution, and flaws in the system of access, including 

13 insurance barriers. 

14 (5) EVALUATIONS.—

15 (A) IN GENERAL.—The Secretary, acting 

16 through the Director of the Indian Health Serv17 ice, shall, directly or through grants or con18 tracts, provide for evaluations to determine 

19 which outreach activities under paragraph (3) 

20 were most effective in informing the public and 

21 the specific community that the program is 

22 serving of the model program services and to 

23 determine the extent to which such programs 

24 were effective in providing culturally competent 
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•HR 2741 IH 

1 services to the health disparity population 

2 served by the programs. 

3 (B) DISSEMINATION OF FINDINGS.—The 

4 Secretary shall as appropriate disseminate to 

5 public and private entities the findings made in 

6 evaluations under subparagraph (A). 

7 (6) COORDINATION WITH OTHER PROGRAMS.—

8 The Secretary shall coordinate the program under 

9 this subsection with—

10 (A) the program under subsection (c); 

11 (B) the program under section 417E–10 of 

12 the Public Health Service Act; and 

13 (C) to the extent practicable, programs for 

14 prevention centers that are carried out by the 

15 Director of the Centers for Disease Control and 

16 Prevention. 

17 (c) PROGRAM FOR PATIENT NAVIGATORS.—

18 (1) IN GENERAL.—The Secretary, acting 

19 through the Director of the Indian Health Service, 

20 may make grants to Indian Health Service Centers, 

21 tribal governments, urban Indian organizations, trib22 al organizations, and qualified nonprofit entities 

23 demonstrating the ability to perform all of the func24 tions in this subsection and subsections (b) and (d) 

25 that partner with providers or centers providing
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•HR 2741 IH 

1 health care services to Native American populations 

2 to provide navigation services, for the development 

3 and operation of model programs to pay the costs 

4 of such entities in carrying out the same activities 

5 outlined in section 417E–10(c)(1) of the Public 

6 Health Service Act. 

7 (2) APPLICATION FOR GRANT.—An entity that 

8 desires to receive a grant under paragraph (1) shall 

9 submit an application to the Secretary at such time, 

10 in such manner, and containing such agreements, 

11 assurances, and information as the Secretary deter12 mines to be necessary to carry out this section. 

13 (3) OUTREACH SERVICES.—In order to be eligi14 ble to receive a grant under paragraph (1), an entity 

15 shall agree to provide ongoing outreach activities 

16 while receiving the grant, in a manner that is cul17 turally competent for the health disparity population 

18 served by the program, to inform the public and the 

19 specific community that the patient navigator is 

20 serving of the services of the model program under 

21 the grant. 

22 (4) DATA COLLECTION AND REPORT.—In order 

23 to allow for effective patient navigator program eval24 uation, an entity that receives a grant under this 

25 subsection shall collect specific patient data record-
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•HR 2741 IH 

1 ing navigation services provided to each patient 

2 served by the program and shall establish and imple3 ment procedures and protocols, consistent with ap4 plicable Federal and State laws (including sections 

5 160 and 164 of title 45, Code of Federal Regula6 tions) to ensure the confidentiality of all information 

7 shared by a participant in the program, or their per8 sonal representative and their health care providers, 

9 group health plans, or health insurance insurers 

10 with the program. The patient navigator program 

11 may, consistent with applicable Federal and State 

12 confidentiality laws, collect, use, or disclose aggre13 gate information that is not individually identifiable 

14 (as defined in sections 160 and 164 of title 45, Code 

15 of Federal Regulations). With this data, the grantee 

16 shall submit an annual report to the Secretary that 

17 summarizes and analyzes the data and provides in18 formation on needs for navigation services, types of 

19 access difficulties resolved, sources of repeated reso20 lution, and flaws in the system of access, including 

21 insurance barriers. 

22 (5) EVALUATIONS.—

23 (A) IN GENERAL.—The Secretary, acting 

24 through the Director of the Indian Health Serv25 ice, shall, directly or through grants or con-
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•HR 2741 IH 

1 tracts, provide for evaluations to determine the 

2 effects of the services of patient navigators on 

3 the individuals of health disparity populations 

4 for whom the services were provided, taking 

5 into account the matters referred to in section 

6 417E-10(c)(1)(C) of the Public Health Service 

7 Act. 

8 (B) DISSEMINATION OF FINDINGS.—The 

9 Secretary shall as appropriate disseminate to 

10 public and private entities the findings made in 

11 evaluations under subparagraph (A).

12 (6) COORDINATION WITH OTHER PROGRAMS.—

13 The Secretary shall coordinate the program under 

14 this subsection with the programs under subsection 

15 (b) and section 417E–10 of the Public Health Serv16 ice Act. 

17 (d) REQUIREMENTS REGARDING FEES.—

18 (1) IN GENERAL.—In order to be eligible to re19 ceive a grant under subsection (b) or (c), the pro20 gram for which the grant is made shall have in ef21 fect—

22 (A) a schedule of fees or payments for the 

23 provision of such program’s health care services 

24 related to the prevention and treatment of dis25 ease that is consistent with locally prevailing 
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1 rates or charges and is designed to cover such 

2 program’s reasonable costs of operation; and 

3 (B) a corresponding schedule of discounts 

4 to be applied to the payment of such fees or 

5 payments, which discounts are adjusted on the 

6 basis of the ability of the patient to pay. 

7 (2) RULE OF CONSTRUCTION.—Nothing in this 

8 subsection shall be construed to require payment for 

9 navigation services or to require payment for health 

10 care services in cases where care is provided free of 

11 charge, including the case of services provided 

12 through programs of the Indian Health Service. 

13 (e) MODEL.—Not later than 5 years after the date 

14 of enactment of this section, the Secretary shall develop 

15 a peer-reviewed model of systems for the services provided 

16 by this section. The Secretary shall update such model as 

17 may be necessary to ensure that the best practices are 

18 being utilized. 

19 (f) DURATION OF GRANT.—The period during which 

20 payments are made to an entity from a grant under sub21 section (b)(1) or (c)(1) may not exceed 5 years. The provi22 sion of such payments are subject to annual approval by 

23 the Secretary and subject to the availability of appropria24 tions for the fiscal year involved. Nothing in this sub25 section shall be construed as establishing a limitation on 
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1 the number of grants under subsections (b) and (c) that 

2 may be made to an entity. 

3 (g) AUTHORIZATION OF APPROPRIATIONS.—

4 (1) IN GENERAL.—

5 (A) MODEL PROGRAMS.—For the purpose 

6 of carrying out subsection (b), there are author7 ized to be appropriated such sums as may be 

8 necessary for each of the fiscal years 2004 

9 through 2008. 

10 (B) PATIENT NAVIGATORS.—For the pur11 pose of carrying out subsection (c), there are 

12 authorized to be appropriated such sums as 

13 may be necessary for each of the fiscal years 

14 2004 through 2008. 

15 (C) BUREAU OF PRIMARY HEALTH

16 CARE.—Amounts appropriated under subpara17 graph (A) or (B) shall be administered through 

18 the Bureau of Primary Health Care. 

19 (2) PROGRAMS IN RURAL AREAS.—

20 (A) MODEL PROGRAMS.—For the purpose 

21 of carrying out subsection (b) in making grants 

22 under such subsection for model programs in 

23 rural areas, there are authorized to be appro24 priated such sums as may be necessary for each 

25 of the fiscal years 2004 through 2008.
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1 (B) PATIENT NAVIGATORS.—For the pur2 pose of carrying out subsection (c) in making 

3 grants under such subsection for programs in 

4 rural areas, there are authorized to be appro5 priated such sums as may be necessary for each 

6 of the fiscal years 2004 through 2008. 

7 (C) OFFICE OF RURAL HEALTH POLICY.—

8 Amounts appropriated under subparagraph (A) 

9 or (B) shall be administered through the Office 

10 of Rural Health Policy. 

11 (3) RELATION TO OTHER AUTHORIZATIONS.—

12 Authorizations of appropriations under paragraphs 

13 (1) and (2) are in addition to other authorizations 

14 of appropriations that are available for the purposes 

15 of carrying out subsections (b) and (c). 

16 TITLE II—EXPANDING ACCESS 

17 TO CANCER DRUGS AND 

18 TREATMENT 

19 SEC. 201. ACCELERATION OF THE DRUG TREATMENT AP20 PROVAL PROCESS OF THE FOOD AND DRUG 

21 ADMINISTRATION. 

22 Not later than July 1, 2004, the Commissioner of 

23 Food and Drugs shall prepare and submit to Congress a 

24 strategic plan that outlines the steps that the Commis-
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1 sioner is taking to accelerate the process for reviewing and 

2 approving new cancer drugs and treatments. 

3 SEC. 202. FDA AMENDMENT. 

4 Section 526(a)(2) of the Federal Food, Drug, and 

5 Cosmetic Act (21 U.S.C. 360bb(a)(2)) is amended by in6 serting ‘‘or targets and mechanisms of pathogenesis of dis7 eases’’ after ‘‘disease or condition’’. 

8 TITLE III—CANCER-RELATED 

9 HEALTH INSURANCE COVERAGE 

10 Subtitle A—Clinical Trials 

11 Coverage 

12 SEC. 301. COVERAGE FOR CLINICAL TRIALS UNDER THE 

13 PUBLIC HEALTH SERVICE ACT. 

14 (a) GROUP.—Subpart 2 of part A of title XXVII of 

15 the Public Health Service Act (42 U.S.C. 300gg–4 et seq.) 

16 is amended by adding at the end the following: 

17 ‘‘SEC. 2707. COVERAGE FOR INDIVIDUALS PARTICIPATING 

18 IN CLINICAL TRIALS. 

19 ‘‘(a) COVERAGE.—

20 ‘‘(1) IN GENERAL.—If a group health plan, or 

21 health insurance issuer that is providing health in22 surance coverage, provides coverage to a qualified in23 dividual (as defined in subsection (b)), the plan or 

24 issuer—
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1 ‘‘(A) may not deny the individual partici2 pation in the clinical trial referred to in sub3 section (b)(2); 

4 ‘‘(B) subject to subsection (c), may not 

5 deny (or limit or impose additional conditions 

6 on) the coverage of routine patient costs for 

7 items and services furnished in connection with 

8 participation in the trial; and

9 ‘‘(C) may not discriminate against the in10 dividual on the basis of the enrollee’s participa11 tion in such trial. 

12 ‘‘(2) EXCLUSION OF CERTAIN COSTS.—For pur13 poses of paragraph (1)(B), routine patient costs do 

14 not include the cost of the tests or measurements 

15 conducted primarily for the purpose of the clinical 

16 trial involved. 

17 ‘‘(3) USE OF IN-NETWORK PROVIDERS.—If 1 or 

18 more participating providers is participating in a 

19 clinical trial, nothing in paragraph (1) shall be con20 strued as preventing a plan or issuer from requiring 

21 that, if a qualified individual is enrolling in the same 

22 clinical trial, the qualified individual participate in 

23 the trial through such a participating provider if the 

24 provider will accept the individual as a participant in 

25 that same trial. If the qualified individual is to enroll 
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•HR 2741 IH 

1 in a trial and no acceptable in-network provider is 

2 participating in the trial or if a participating pro3 vider cannot accept new enrollees, then the qualified 

4 individual may enroll in the trial through an out-of5 network provider. 

6 ‘‘(b) QUALIFIED INDIVIDUAL DEFINED.—For pur7 poses of subsection (a), the term ‘qualified individual’ 

8 means an individual who has cancer and is a participant 

9 or beneficiary in a group health plan, or who is an enrollee 

10 under health insurance coverage, and who meets the fol11 lowing conditions: 

12 ‘‘(1) The individual is eligible to participate in 

13 an approved clinical trial according to the trial pro14 tocol with respect to treatment of such illness. 

15 ‘‘(2) Either the referring physician is author16 ized by the plan to treat the patient and has con17 cluded that the individual’s participation in such 

18 trial would be appropriate based upon the individual 

19 meeting the condition described in paragraph (1), or 

20 the participant, beneficiary, or enrollee provides 

21 medical and scientific information establishing that 

22 the individual’s participation in such trial would be 

23 appropriate based upon the individual meeting the 

24 condition described in paragraph (1). 

25 ‘‘(c) PAYMENT.—
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1 ‘‘(1) IN GENERAL.—Under this section a group 

2 health plan and a health insurance issuer shall pro3 vide for payment for routine patient costs described 

4 in subsection (a)(2) but are not required to pay for 

5 costs of items and services that are reasonably ex6 pected (as determined by the appropriate Secretary) 

7 to be paid for by the sponsors of an approved clin8 ical trial. 

9 ‘‘(2) PAYMENT RATE.—In the case of covered 

10 items and services provided by—

11 ‘‘(A) a participating provider, the payment 

12 rate shall be at the agreed upon rate; or 

13 ‘‘(B) a nonparticipating provider, the pay14 ment rate shall be at the rate the plan or issuer 

15 would normally pay for comparable services 

16 under subparagraph (A). 

17 ‘‘(d) APPROVED CLINICAL TRIAL DEFINED.—In this 

18 section, the term ‘approved clinical trial’ means a clinical 

19 research study or clinical investigation—

20 ‘‘(1) approved and funded (which may include 

21 funding through in-kind contributions) by—

22 ‘‘(A) the National Institutes of Health; 

23 ‘‘(B) a cooperative group or center of the 

24 National Institutes of Health, including a quali25 fied nongovernmental research entity to which
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1 the National Cancer Institute has awarded a 

2 center support grant; 

3 ‘‘(C) the Department of Veterans Affairs, 

4 if the conditions described in subsection (e) are 

5 met; or 

6 ‘‘(D) the Department of Defense, if the 

7 conditions described in subsection (e) are met; 

8 ‘‘(2) approved by the Food and Drug Adminis9 tration; or 

10 ‘‘(3) approved by a qualified nongovernmental 

11 research entity identified in the guidelines issued by 

12 the National Institutes of Health for center support 

13 grants or an institutional review board that—

14 ‘‘(A) is registered with the Department of 

15 Health and Human Services; and 

16 ‘‘(B) is associated with an institution that 

17 has a Federal assurance approved by the De18 partment of Health and Human Services speci19 fying compliance with section 46 of title 45, 

20 Code of Federal Regulations. 

21 ‘‘(e) CONDITIONS FOR DEPARTMENTS.—The condi22 tions for a study or investigation conducted by a depart23 ment, are that the study or investigation has been re24 viewed and approved through a system of peer review that 

25 the appropriate Secretary determines—
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1 ‘‘(1) to be comparable to the system of peer re2 view of studies and investigations used by the Na3 tional Institutes of Health; and 

4 ‘‘(2) assures unbiased review of the highest eth5 ical standards by an institutional review board or 

6 other body that meets the standards outlined in sec7 tion 46 of title 45, and sections 50 and 56 of title 

8 21, Code of Federal Regulations. 

9 ‘‘(f) CONSTRUCTION.—Nothing in this section shall 

10 be construed to limit a plan’s or issuer’s coverage with 

11 respect to clinical trials.’’. 

12 (b) INDIVIDUAL.—Part B of title XXVII of the Pub13 lic Health Service Act is amended by inserting after sec14 tion 2752 (42 U.S.C. 300gg–52) the following: 

15 ‘‘SEC. 2753. PATIENT PROTECTION STANDARDS. 

16 ‘‘The provisions of section 2707 shall apply to health 

17 insurance coverage offered by a health insurance issuer 

18 in the individual market in the same manner as such pro19 visions apply to health insurance coverage offered by a 

20 health insurance issuer in connection with a group health 

21 plan.’’. 
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1 SEC. 302. COVERAGE FOR CLINICAL TRIALS UNDER THE 

2 EMPLOYEE RETIREMENT INCOME SECURITY 

3 ACT OF 1974. 

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

5 B of title I of the Employee Retirement Income Security 

6 Act of 1974 (29 U.S.C. 1185 et seq.) is amended by add7 ing at the end the following: 

8 ‘‘SEC. 714. COVERAGE FOR INDIVIDUALS PARTICIPATING IN 

9 CLINICAL TRIALS. 

10 ‘‘(a) COVERAGE.—

11 ‘‘(1) IN GENERAL.—If a group health plan, or 

12 health insurance issuer that is providing health in13 surance coverage, provides coverage to a qualified in14 dividual (as defined in subsection (b)), the plan or 

15 issuer—

16 ‘‘(A) may not deny the individual partici17 pation in the clinical trial referred to in sub18 section (b)(2); 

19 ‘‘(B) subject to subsection (c), may not 

20 deny (or limit or impose additional conditions 

21 on) the coverage of routine patient costs for 

22 items and services furnished in connection with 

23 participation in the trial; and 

24 ‘‘(C) may not discriminate against the in25 dividual on the basis of the enrollee’s participa26 tion in such trial. 
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1 ‘‘(2) EXCLUSION OF CERTAIN COSTS.—For pur2 poses of paragraph (1)(B), routine patient costs do 

3 not include the cost of the tests or measurements 

4 conducted primarily for the purpose of the clinical 

5 trial involved. 

6 ‘‘(3) USE OF IN-NETWORK PROVIDERS.—If 1 or 

7 more participating providers is participating in a 

8 clinical trial, nothing in paragraph (1) shall be con9 strued as preventing a plan or issuer from requiring 

10 that, if a qualified individual is enrolling in the same 

11 clinical trial, the qualified individual participate in 

12 the trial through such a participating provider if the 

13 provider will accept the individual as a participant in 

14 that same trial. If the qualified individual is to enroll 

15 in a trial and no acceptable in-network provider is 

16 participating in the trial or if a participating pro17 vider cannot accept new enrollees, then the qualified 

18 individual may enroll in the trial through an out-of19 network provider. 

20 ‘‘(b) QUALIFIED INDIVIDUAL DEFINED.—For pur21 poses of subsection (a), the term ‘qualified individual’ 

22 means an individual who has cancer and is a participant 

23 or beneficiary in a group health plan, or who is an enrollee 

24 under health insurance coverage, and who meets the fol25 lowing conditions: 
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1 ‘‘(1) The individual is eligible to participate in 

2 an approved clinical trial according to the trial pro3 tocol with respect to treatment of such illness. 

4 ‘‘(2) Either the referring physician is author5 ized by the plan to treat the patient and has con6 cluded that the individual’s participation in such 

7 trial would be appropriate based upon the individual 

8 meeting the condition described in paragraph (1), or 

9 the participant, beneficiary, or enrollee provides 

10 medical and scientific information establishing that 

11 the individual’s participation in such trial would be 

12 appropriate based upon the individual meeting the 

13 condition described in paragraph (1). 

14 ‘‘(c) PAYMENT.—

15 ‘‘(1) IN GENERAL.—Under this section a group 

16 health plan and a health insurance issuer shall pro17 vide for payment for routine patient costs described 

18 in subsection (a)(2) but are not required to pay for 

19 costs of items and services that are reasonably ex20 pected (as determined by the appropriate Secretary) 

21 to be paid for by the sponsors of an approved clin22 ical trial. 

23 ‘‘(2) PAYMENT RATE.—In the case of covered 

24 items and services provided by—
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1 ‘‘(A) a participating provider, the payment 

2 rate shall be at the agreed upon rate; or 

3 ‘‘(B) a nonparticipating provider, the pay4 ment rate shall be at the rate the plan or issuer 

5 would normally pay for comparable services 

6 under subparagraph (A). 

7 ‘‘(d) APPROVED CLINICAL TRIAL DEFINED.—In this 

8 section, the term ‘approved clinical trial’ means a clinical 

9 research study or clinical investigation—

10 ‘‘(1) approved and funded (which may include 

11 funding through in-kind contributions) by—

12 ‘‘(A) the National Institutes of Health; 

13 ‘‘(B) a cooperative group or center of the 

14 National Institutes of Health, including a quali15 fied nongovernmental research entity to which 

16 the National Cancer Institute has awarded a 

17 center support grant; 

18 ‘‘(C) the Department of Veterans Affairs, 

19 if the conditions described in subsection (e) are 

20 met; or 

21 ‘‘(D) the Department of Defense, if the 

22 conditions described in subsection (e) are met; 

23 ‘‘(2) approved by the Food and Drug Adminis24 tration; or 
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1 ‘‘(3) approved by a qualified nongovernmental 

2 research entity identified in the guidelines issued by 

3 the National Institutes of Health for center support 

4 grants or an institutional review board that—

5 ‘‘(A) is registered with the Department of 

6 Health and Human Services; and 

7 ‘‘(B) is associated with an institution that 

8 has a Federal assurance approved by the De9 partment of Health and Human Services speci10 fying compliance with section 46 of title 45, 

11 Code of Federal Regulations. 

12 ‘‘(e) CONDITIONS FOR DEPARTMENTS.—The condi13 tions for a study or investigation conducted by a depart14 ment, are that the study or investigation has been re15 viewed and approved through a system of peer review that 

16 the appropriate Secretary determines—

17 ‘‘(1) to be comparable to the system of peer re18 view of studies and investigations used by the Na19 tional Institutes of Health; and 

20 ‘‘(2) assures unbiased review of the highest eth21 ical standards by an institutional review board or 

22 other body that meets the standards outlined in sec23 tion 46 of title 45, and sections 50 and 56 of title 

24 21, Code of Federal Regulations. 
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1 ‘‘(f) CONSTRUCTION.—Nothing in this section shall 

2 be construed to limit a plan’s or issuer’s coverage with 

3 respect to clinical trials.’’. 

4 (b) CONFORMING AMENDMENT.—The table of con5 tents in section 1 of the Employee Retirement Income Se6 curity Act of 1974 is amended by inserting after the item 

7 relating to section 713 the following new item:

‘‘Sec. 714. Coverage for individuals participating in clinical trials.’’.

8 SEC. 303. COVERAGE FOR CLINICAL TRIALS UNDER OTHER 

9 PUBLIC HEALTH INSURANCE. 

10 Coverage for individuals participating in clinical 

11 trials, as described in section 2707 and 2753 of the Public 

12 Health Service Act (as added under section 301), shall be 

13 provided for any individual, participant, or beneficiary who 

14 have coverage under—

15 (1) the medicaid program under title XIX of 

16 the Social Security Act (42 U.S.C. 1396 et seq.); 

17 (2) the medicare program under title XVIII of 

18 the Social Security Act (42 U.S.C. 1395 et seq.); 

19 (3) the State Children’s Health Insurance Pro20 gram under title XXI of the Social Security Act (42 

21 U.S.C. 1398 et seq.); 

22 (4) a health plan offered under chapter 89 of 

23 title 5, United States Code; 

24 (5) programs offered by the Department of De25 fense; 
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1 (6) a medical care program of the Indian 

2 Health Service or of a tribal organization; and 

3 (7) a health benefit plan under section 5(e) of 

4 the Peace Corps Act (22 U.S.C. 2504(e)). 

5 Subtitle B—Cancer Screening and 

6 Other Coverage 

7 SEC. 311. CANCER SCREENING COVERAGE. 

8 (a) GROUP HEALTH PLANS.—

9 (1) PUBLIC HEALTH SERVICE ACT AMEND10 MENTS.—

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

12 title XXVII of the Public Health Service Act 

13 (42 U.S.C. 300gg–4 et seq.), as amended by 

14 section 301(a), is further amended by adding at 

15 the end the following: 

16 ‘‘SEC. 2708. COVERAGE OF CANCER SCREENING. 

17 ‘‘(a) REQUIREMENT.—A group health plan, and a 

18 health insurance issuer offering group health insurance 

19 coverage, shall provide coverage and payment under the 

20 plan or coverage for the following items and services under 

21 terms and conditions that are no less favorable than the 

22 terms and conditions applicable to other screening benefits 

23 otherwise provided under the plan or coverage: 

24 ‘‘(1) MAMMOGRAMS.—In the case of a female 

25 participant or beneficiary who is 40 years of age or 
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1 older, or is under 40 years of age but is at high risk 

2 (as defined in subsection (e)) of developing breast 

3 cancer, an annual mammography (as defined in sec4 tion 1861(jj) of the Social Security Act) conducted 

5 by a facility that has a certificate (or provisional cer6 tificate) issued under section 354. 

7 ‘‘(2) CLINICAL BREAST EXAMINATIONS.—In the 

8 case of a female participant or beneficiary who—

9 ‘‘(A)(i) is 40 years of age or older or (ii) 

10 is at least 20 (but less than 40) years of age 

11 and is at high risk of developing breast cancer, 

12 an annual clinical breast examination; or 

13 ‘‘(B) is at least 20, but less than 40, years 

14 of age and who is not at high risk of developing 

15 breast cancer, a clinical breast examination 

16 each 3 years. 

17 ‘‘(3) PAP TESTS AND PELVIC EXAMINATIONS.—

18 In the case of a female participant or beneficiary 

19 who is 18 years of age or older, or who is under 18 

20 years of age and is or has been sexually active—

21 ‘‘(A) an annual diagnostic laboratory test 

22 (popularly known as a ‘pap smear’) consisting 

23 of a routine exfoliative cytology test (Papani24 colaou test) provided to a woman for the pur25 pose of early detection of cervical or vaginal
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•HR 2741 IH 

1 cancer and including an interpretation by a 

2 qualified health professional of the results of 

3 the test; and 

4 ‘‘(B) an annual pelvic examination. 

5 ‘‘(4) COLORECTAL CANCER SCREENING PROCE6 DURES.—

7 ‘‘(A) IN GENERAL.—In the case of a par8 ticipant or beneficiary who is 50 years of age or 

9 older, or who is under 50 years of age and is 

10 an individual at high risk for colorectal cancer, 

11 the group health plan or health insurance issuer 

12 shall cover methods of colorectal cancer screen13 ing that—

14 ‘‘(i) are deemed appropriate by a phy15 sician (as defined in section 1861(r) of the 

16 Social Security Act (42 U.S.C. 1395x(r))) 

17 treating the participant or beneficiary, in 

18 consultation with the participant or bene19 ficiary; 

20 ‘‘(ii) are—

21 ‘‘(I) described in section 

22 1861(pp)(1) of the Social Security Act 

23 (42 U.S.C. 1395x(pp)(1)) or section 

24 410.37 of title 42, Code of Federal 

25 Regulations; or 
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1 ‘‘(II) specified by the Secretary 

2 based upon the recommendations of 

3 appropriate organizations with special 

4 expertise in the field of colorectal can5 cer; and 

6 ‘‘(iii) are performed at a frequency 

7 not greater than that—

8 ‘‘(I) described for such method in 

9 section 1834(d) of the Social Security 

10 Act (42 U.S.C. 1395m(d)) or section 

11 410.37 of title 42, Code of Federal 

12 Regulations; or 

13 ‘‘(II) specified by the Secretary 

14 for such method if the Secretary 

15 finds, based upon new scientific 

16 knowledge and consistent with the 

17 recommendations of appropriate orga18 nizations with special expertise in the 

19 field of colorectal cancer, that a dif20 ferent frequency would not adversely 

21 affect the effectiveness of such screen22 ing. 

23 ‘‘(B) DEFINITION OF HIGH RISK.—In this 

24 paragraph, the term ‘individual at high risk for 

25 colorectal cancer’ has the meaning given the 
79

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1 term in section 1861(pp)(2) of the Social Secu2 rity Act (42 U.S.C. 1395x(pp)(2)). 

3 ‘‘(5) PROSTATE CANCER SCREENING.—In the 

4 case of a male participant or beneficiary who is 50 

5 years of age or older, or who is younger than 50 

6 years of age and is at high risk for prostate cancer 

7 (including African American men or a male who has

8 a history of prostate cancer in a first degree family 

9 member), the procedures described in section 

10 1861(oo)(2) of Social Security Act (42 U.S.C. 

11 1395x(oo)(2)) shall be furnished to the individual 

12 for the early detection of prostate cancer. The group 

13 health plan or health insurance issuer shall provide 

14 coverage for the method and frequency of prostate 

15 cancer screening determined to be appropriate by a 

16 health care provider treating such participant or 

17 beneficiary, in consultation with the participant or 

18 beneficiary. 

19 ‘‘(6) TOBACCO THERAPY AND COUNSELING.—

20 ‘‘(A) IN GENERAL.—Therapy and coun21 seling for cessation of tobacco use for individ22 uals who use tobacco products or who are being 

23 treated for tobacco use that is furnished—

24 ‘‘(i) by or under the supervision of a 

25 physician; or 
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•HR 2741 IH 

1 ‘‘(ii) by any other health care profes2 sional— 

3 ‘‘(I) who is legally authorized to 

4 furnish such services under State law 

5 (or the State regulatory mechanism 

6 provided by State law) of the State in 

7 which the services are furnished; and 

8 ‘‘(II) who, for medicare bene9 ficiaries, is authorized to receive pay10 ment for other services under this title 

11 or is designated by the Secretary for 

12 this purpose. 

13 ‘‘(B) LIMITATION.—Subject to subpara14 graph (C), such therapy and counseling are lim15 ited to—

16 ‘‘(i) therapy and counseling services 

17 recommended in ‘Treating Tobacco Use 

18 and Dependence: A Clinical Practice 

19 Guideline’, published by the Public Health 

20 Service in June 2000, or any subsequent 

21 modification of such Guideline; and 

22 ‘‘(ii) such other therapy and coun23 seling services that the Secretary recog24 nizes to be effective. 
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•HR 2741 IH 

1 ‘‘(C) EXCLUSION.—Such therapy and 

2 counseling shall not include coverage for drugs 

3 or biologicals that are not otherwise covered 

4 under the plan or coverage. 

5 ‘‘(7) MEDICAL NUTRITION THERAPY SERV6 ICES.—Medical nutrition therapy services, as defined 

7 in section 1861(vv) of the Social Security Act (42 

8 U.S.C. 1395x(vv)) for the purpose of improving the 

9 health of cancer patients and preventing cancer in 

10 other beneficiaries. 

11 ‘‘(8) GENETIC TESTS AND GENETIC SERV12 ICES.—

13 ‘‘(A) IN GENERAL.—Genetic tests and ge14 netic services provided by a licensed health care 

15 professional to obtain predictive genetic infor16 mation about an individual at risk of cancer for 

17 purposes of a health assessment, cancer man18 agement, cancer prevention, other diagnostic or 

19 therapeutic purposes, or genetic education and 

20 counseling. 

21 ‘‘(B) DEFINITIONS.—In this paragraph: 

22 ‘‘(i) FAMILY MEMBER.—The term 

23 ‘family member’ means with respect to an 

24 individual—

25 ‘‘(I) the spouse of the individual;
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1 ‘‘(II) a dependent child of the in2 dividual, including a child who is born 

3 to or placed for adoption with the in4 dividual; and 

5 ‘‘(III) all other individuals re6 lated by blood to the individual or the 

7 spouse or child described in subclause 

8 (I) or (II). 

9 ‘‘(ii) GENETIC INFORMATION.—The 

10 term ‘genetic information’ means informa11 tion about genes, gene products, or inher12 ited characteristics that may derive from 

13 an individual or a family member of such 

14 individual (including information about a 

15 request for or the receipt of genetic serv16 ices by such individual or family member 

17 of such individual). 

18 ‘‘(iii) GENETIC SERVICES.—The term 

19 ‘genetic services’ means health services, in20 cluding genetic tests, provided to obtain, 

21 assess, or interpret genetic information for 

22 diagnostic and therapeutic purposes, and 

23 for genetic education and counseling. 

24 ‘‘(iv) GENETIC TEST.—The term ‘ge25 netic test’ means the analysis of human 
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•HR 2741 IH 

1 DNA, RNA, chromosomes, proteins, and 

2 certain metabolites in order to detect 

3 genotypes, mutations, or chromosomal 

4 changes. 

5 ‘‘(v) PREDICTIVE GENETIC INFORMA6 TION.—

7 ‘‘(I) IN GENERAL.—The term 

8 ‘predictive genetic information’ 

9 means—

10 ‘‘(aa) information about an 

11 individual’s genetic tests; 

12 ‘‘(bb) information about ge13 netic tests of family members of 

14 the individual; or 

15 ‘‘(cc) information about the 

16 occurrence of a disease or dis17 order in family members. 

18 ‘‘(II) LIMITATIONS.—The term 

19 ‘predictive genetic information’ shall 

20 not include—

21 ‘‘(aa) information about the 

22 sex or age of the individual; 

23 ‘‘(bb) information about 

24 chemical, blood, or urine analyses 
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•HR 2741 IH 

1 of the individual, unless these 

2 analyses are genetic tests; or 

3 ‘‘(cc) information about 

4 physical exams of the individual, 

5 and other information relevant to 

6 determining the current health 

7 status of the individual.

8 ‘‘(9) OTHER TESTS AND PROCEDURES.—Such 

9 other tests or procedures for the detection of cancer, 

10 and modifications to the tests and procedures, with 

11 such frequency, as the Secretary determines to be 

12 appropriate, in consultation with appropriate organi13 zations and agencies, for the diagnosis or detection 

14 of cancer.

15 ‘‘(b) PROHIBITIONS.—A group health plan, and a 

16 health insurance issuer offering group health insurance 

17 coverage in connection with a group health plan, shall 

18 not—

19 ‘‘(1) deny to an individual eligibility, or contin20 ued eligibility, to enroll or to renew coverage under 

21 the terms of the plan, solely for the purpose of 

22 avoiding the requirements of this section; 

23 ‘‘(2) provide monetary payments or rebates to 

24 individuals to encourage such individuals to accept 
85

•HR 2741 IH 

1 less than the minimum protections available under 

2 this section; 

3 ‘‘(3) penalize or otherwise reduce or limit the 

4 reimbursement of a provider because such provider 

5 provided care to an individual participant or bene6 ficiary in accordance with this section; or 

7 ‘‘(4) provide incentives (monetary or otherwise) 

8 to a provider to induce such provider to provide care 

9 to an individual participant or beneficiary in a man10 ner inconsistent with this section. 

11 ‘‘(c) RULES OF CONSTRUCTION.—

12 ‘‘(1) Nothing in this section shall be construed 

13 to require an individual who is a participant or bene14 ficiary to undergo a procedure, examination, or test 

15 described in subsection (a). 

16 ‘‘(2) Nothing in this section shall be construed 

17 as preventing a group health plan or issuer from im18 posing deductibles, coinsurance, or other cost-shar19 ing in relation to benefits described in subsection (a) 

20 consistent with such subsection, except that such co21 insurance or other cost-sharing shall not discrimi22 nate on any basis related to the coverage required 

23 under this section. 
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•HR 2741 IH 

1 ‘‘(3) Nothing in this section shall be construed 

2 to result in a reduction, diminishment, or change in 

3 coverage resulting in less coverage. 

4 ‘‘(d) NOTICE.—A group health plan under this part 

5 shall comply with the notice requirement under section 

6 714(d) of the Employee Retirement Income Security Act 

7 of 1974 with respect to the requirements of this section 

8 as if such section applied to such plan. 

9 ‘‘(e) RISK DEFINED.—For purposes of this section, 

10 an individual is considered to be at ‘risk’ of developing 

11 a particular type of cancer if, under guidelines developed 

12 or recognized by the Secretary based upon scientific evi13 dence, the individual—

14 ‘‘(1) has 1 or more first degree family members 

15 who have developed that type of cancer; 

16 ‘‘(2) has previously had that type of cancer; 

17 ‘‘(3) has the presence of an appropriate recog18 nized gene marker that is identified as putting the 

19 individual at a higher risk of developing that type of 

20 cancer; or 

21 ‘‘(4) has other predisposing or environmental 

22 risk factors that significantly increases the risk of 

23 the individual contracting that type of cancer.
87

•HR 2741 IH 

1 For purposes of this subsection, the term ‘type of cancer’ 

2 includes other types of cancer that the Secretary recog3 nizes as closely related for purposes of establishing risk. 

4 ‘‘SEC. 2709. PATIENT ACCESS TO INFORMATION. 

5 ‘‘(a) DISCLOSURE REQUIREMENT.—A group health 

6 plan, and health insurance issuer offering group health in7 surance coverage shall—

8 ‘‘(1) provide to participants and beneficiaries at 

9 the time of initial coverage under the plan (or the 

10 effective date of this section, in the case of individ11 uals who are participants or beneficiaries as of such 

12 date), and at least annually thereafter, the informa13 tion described in subsection (b) in printed form; 

14 ‘‘(2) provide to participants and beneficiaries, 

15 within a reasonable period (as specified by the ap16 propriate Secretary) before or after the date of sig17 nificant changes in the information described in sub18 section (b), information in printed form regarding 

19 such significant changes; and 

20 ‘‘(3) upon request, make available to partici21 pants and beneficiaries, the applicable authority, and 

22 prospective participants and beneficiaries, the infor23 mation described in subsection (b) in printed form. 

24 ‘‘(b) INFORMATION PROVIDED.—The information de25 scribed in subsection (a) that shall be disclosed includes 
88

•HR 2741 IH 

1 the following, as such relates to cancer screening required 

2 under section 2708(a): 

3 ‘‘(1) BENEFITS.—Benefits offered under the 

4 plan or coverage, including—

5 ‘‘(A) covered benefits, including benefit 

6 limits and coverage exclusions; 

7 ‘‘(B) cost-sharing, such as deductibles, co8 insurance, and copayment amounts, including 

9 any liability for balance billing, any maximum 

10 limitations on out of pocket expenses, and the 

11 maximum out of pocket costs for services that 

12 are provided by nonparticipating providers or 

13 that are furnished without meeting the applica14 ble utilization review requirements; 

15 ‘‘(C) the extent to which benefits may be 

16 obtained from nonparticipating providers; and 

17 ‘‘(D) the extent to which a participant, 

18 beneficiary, or enrollee may select from among 

19 participating providers and the types of pro20 viders participating in the plan or issuer net21 work. 

22 ‘‘(2) ACCESS.—A description of the following: 

23 ‘‘(A) The number, mix, and distribution of 

24 providers under the plan or coverage. 
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•HR 2741 IH 

1 ‘‘(B) Out-of-network coverage (if any) pro2 vided by the plan or coverage. 

3 ‘‘(C) Any point-of-service option (including 

4 any supplemental premium or cost-sharing for 

5 such option). 

6 ‘‘(D) The procedures for participants, 

7 beneficiaries, and enrollees to select, access, and 

8 change participating primary and specialty pro9 viders. 

10 ‘‘(E) The rights and procedures for obtain11 ing referrals (including standing referrals) to 

12 participating and nonparticipating providers.

13 ‘‘(F) The name, address, and telephone 

14 number of participating health care providers 

15 and an indication of whether each such provider 

16 is available to accept new patients. 

17 ‘‘(G) How the plan or issuer addresses the 

18 needs of participants, beneficiaries, and enroll19 ees and others who do not speak English or 

20 who have other special communications needs in 

21 accessing providers under the plan or coverage, 

22 including the provision of information under 

23 this subsection.’’. 

24 (B) TECHNICAL AMENDMENT.—Section 

25 2723(c) of the Public Health Service Act (42 
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•HR 2741 IH 

1 U.S.C. 300gg–23(c)) is amended by striking 

2 ‘‘section 2704’’ and inserting ‘‘sections 2704 

3 and 2708’’. 

4 (2) ERISA AMENDMENTS.—

5 (A) IN GENERAL.—Subpart B of part 7 of 

6 subtitle B of title I of the Employee Retirement 

7 Income Security Act of 1974 (29 U.S.C. 1185 

8 et seq.), as amended by section 302, is further 

9 amended by adding at the end the following 

10 new section: 

11 ‘‘SEC. 715. COVERAGE OF CANCER SCREENING. 

12 ‘‘(a) REQUIREMENT.—A group health plan, and a 

13 health insurance issuer offering group health insurance 

14 coverage, shall provide coverage and payment under the 

15 plan or coverage for the following items and services under 

16 terms and conditions that are no less favorable than the

17 terms and conditions applicable to other screening benefits 

18 otherwise provided under the plan or coverage: 

19 ‘‘(1) MAMMOGRAMS.—In the case of a female 

20 participant or beneficiary who is 40 years of age or 

21 older, or is under 40 years of age but is at high risk 

22 (as defined in subsection (e)) of developing breast 

23 cancer, an annual mammography (as defined in sec24 tion 1861(jj) of the Social Security Act) conducted 

25 by a facility that has a certificate (or provisional cer-
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•HR 2741 IH 

1 tificate) issued under section 354 of the Public 

2 Health Service Act. 

3 ‘‘(2) CLINICAL BREAST EXAMINATIONS.—In the 

4 case of a female participant or beneficiary who—

5 ‘‘(A)(i) is 40 years of age or older or (ii) 

6 is at least 20 (but less than 40) years of age 

7 and is at high risk of developing breast cancer, 

8 an annual clinical breast examination; or 

9 ‘‘(B) is at least 20, but less than 40, years 

10 of age and who is not at high risk of developing 

11 breast cancer, a clinical breast examination 

12 each 3 years. 

13 ‘‘(3) PAP TESTS AND PELVIC EXAMINATIONS.—

14 In the case of a female participant or beneficiary 

15 who is 18 years of age or older, or who is under 18 

16 years of age and is or has been sexually active—

17 ‘‘(A) an annual diagnostic laboratory test 

18 (popularly known as a ‘pap smear’) consisting 

19 of a routine exfoliative cytology test (Papani20 colaou test) provided to a woman for the pur21 pose of early detection of cervical or vaginal

22 cancer and including an interpretation by a 

23 qualified health professional of the results of 

24 the test; and 

25 ‘‘(B) an annual pelvic examination.
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•HR 2741 IH 

1 ‘‘(4) COLORECTAL CANCER SCREENING PROCE2 DURES.—

3 ‘‘(A) IN GENERAL.—In the case of a par4 ticipant or beneficiary who is 50 years of age or 

5 older, or who is under 50 years of age and is 

6 an individual at high risk for colorectal cancer, 

7 the group health plan or health insurance issuer 

8 shall cover methods of colorectal cancer screen9 ing that—

10 ‘‘(i) are deemed appropriate by a phy11 sician (as defined in section 1861(r) of the 

12 Social Security Act (42 U.S.C. 1395x(r))) 

13 treating the participant or beneficiary, in 

14 consultation with the participant or bene15 ficiary; 

16 ‘‘(ii) are—

17 ‘‘(I) described in section 

18 1861(pp)(1) of the Social Security Act 

19 (42 U.S.C. 1395x(pp)(1)) or section 

20 410.37 of title 42, Code of Federal 

21 Regulations; or 

22 ‘‘(II) specified by the Secretary 

23 based upon the recommendations of 

24 appropriate organizations with special 
93

•HR 2741 IH 

1 expertise in the field of colorectal can2 cer; and 

3 ‘‘(iii) are performed at a frequency 

4 not greater than that—

5 ‘‘(I) described for such method in 

6 section 1834(d) of the Social Security 

7 Act (42 U.S.C. 1395m(d)) or section 

8 410.37 of title 42, Code of Federal 

9 Regulations; or 

10 ‘‘(II) specified by the Secretary 

11 for such method if the Secretary 

12 finds, based upon new scientific 

13 knowledge and consistent with the 

14 recommendations of appropriate orga15 nizations with special expertise in the 

16 field of colorectal cancer, that a dif17 ferent frequency would not adversely 

18 affect the effectiveness of such screen19 ing. 

20 ‘‘(B) DEFINITION OF HIGH RISK.—In this 

21 paragraph, the term ‘individual at high risk for 

22 colorectal cancer’ has the meaning given the 

23 term in section 1861(pp)(2) of the Social Secu24 rity Act (42 U.S.C. 1395x(pp)(2)). 
94

•HR 2741 IH 

1 ‘‘(5) PROSTATE CANCER SCREENING.—In the 

2 case of a male participant or beneficiary who is 50 

3 years of age or older, or who is younger than 50 

4 years of age and is at high risk for prostate cancer 

5 (including African American men or a male who has 

6 a history of prostate cancer in a first degree family 

7 member), the procedures described in section 

8 1861(oo)(2) of the Social Security Act (42 U.S.C. 

9 1395x(oo)(2)) shall be furnished to the individual 

10 for the early detection of prostate cancer. The group

11 health plan or health insurance issuer shall provide 

12 coverage for the method and frequency of prostate 

13 cancer screening determined to be appropriate by a 

14 health care provider treating such participant or 

15 beneficiary, in consultation with the participant or 

16 beneficiary. 

17 ‘‘(6) TOBACCO THERAPY AND COUNSELING.—

18 ‘‘(A) IN GENERAL.—Therapy and coun19 seling for cessation of tobacco use for individ20 uals who use tobacco products or who are being 

21 treated for tobacco use that is furnished—

22 ‘‘(i) by or under the supervision of a 

23 physician; or 

24 ‘‘(ii) by any other health care profes25 sional who— 
95

•HR 2741 IH 

1 ‘‘(I) is legally authorized to fur2 nish such services under State law (or 

3 the State regulatory mechanism pro4 vided by State law) of the State in 

5 which the services are furnished; and 

6 ‘‘(II) for medicare beneficiaries, 

7 is authorized to receive payment for 

8 other services under this title or is 

9 designated by the Secretary for this 

10 purpose. 

11 ‘‘(B) LIMITATION.—Subject to subpara12 graph (C), such therapy and counseling are lim13 ited to—

14 ‘‘(i) therapy and counseling services 

15 recommended in ‘Treating Tobacco Use 

16 and Dependence: A Clinical Practice 

17 Guideline’, published by the Public Health 

18 Service in June 2000, or any subsequent 

19 modification of such Guideline; and 

20 ‘‘(ii) such other therapy and coun21 seling services that the Secretary recog22 nizes to be effective. 

23 ‘‘(C) EXCLUSION.—Such therapy and 

24 counseling shall not include coverage for drugs 
96

•HR 2741 IH 

1 or biologicals that are not otherwise covered 

2 under the plan or coverage. 

3 ‘‘(7) MEDICAL NUTRITION THERAPY SERV4 ICES.—Medical nutrition therapy services, as defined 

5 in section 1861(vv) of the Social Security Act (42 

6 U.S.C. 1395x(vv)) for the purpose of improving the 

7 health of cancer patients and preventing cancer in 

8 other beneficiaries. 

9 ‘‘(8) GENETIC TESTS AND GENETIC SERV10 ICES.—

11 ‘‘(A) IN GENERAL.—Genetic tests and ge12 netic services provided by a licensed health care 

13 professional to obtain predictive genetic infor14 mation about an individual at risk of cancer for 

15 purposes of a health assessment, cancer man16 agement, cancer prevention, other diagnostic or 

17 therapeutic purposes, or genetic education and 

18 counseling. 

19 ‘‘(B) DEFINITIONS.—In this paragraph: 

20 ‘‘(i) FAMILY MEMBER.—The term 

21 ‘family member’ means with respect to an 

22 individual—

23 ‘‘(I) the spouse of the individual; 

24 ‘‘(II) a dependent child of the in25 dividual, including a child who is born
97

•HR 2741 IH 

1 to or placed for adoption with the in2 dividual; and 

3 ‘‘(III) all other individuals re4 lated by blood to the individual or the 

5 spouse or child described in subclause 

6 (I) or (II). 

7 ‘‘(ii) GENETIC INFORMATION.—The 

8 term ‘genetic information’ means informa9 tion about genes, gene products, or inher10 ited characteristics that may derive from 

11 an individual or a family member of such 

12 individual (including information about a 

13 request for or the receipt of genetic serv14 ices by such individual or family member 

15 of such individual). 

16 ‘‘(iii) GENETIC SERVICES.—The term 

17 ‘genetic services’ means health services, in18 cluding genetic tests, provided to obtain, 

19 assess, or interpret genetic information for 

20 diagnostic and therapeutic purposes, and 

21 for genetic education and counseling. 

22 ‘‘(iv) GENETIC TEST.—The term ‘ge23 netic test’ means the analysis of human 

24 DNA, RNA, chromosomes, proteins, and 

25 certain metabolites in order to detect
98

•HR 2741 IH 

1 genotypes, mutations, or chromosomal 

2 changes. 

3 ‘‘(v) PREDICTIVE GENETIC INFORMA4 TION.—

5 ‘‘(I) IN GENERAL.—The term 

6 ‘predictive genetic information’ 

7 means—

8 ‘‘(aa) information about an 

9 individual’s genetic tests;

10 ‘‘(bb) information about ge11 netic tests of family members of 

12 the individual; or 

13 ‘‘(cc) information about the 

14 occurrence of a disease or dis15 order in family members. 

16 ‘‘(II) LIMITATIONS.—The term 

17 ‘predictive genetic information’ shall 

18 not include—

19 ‘‘(aa) information about the 

20 sex or age of the individual; 

21 ‘‘(bb) information about 

22 chemical, blood, or urine analyses 

23 of the individual, unless these 

24 analyses are genetic tests; or 
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•HR 2741 IH 

1 ‘‘(cc) information about 

2 physical exams of the individual, 

3 and other information relevant to 

4 determining the current health 

5 status of the individual. 

6 ‘‘(9) OTHER TESTS AND PROCEDURES.—Such 

7 other tests or procedures for the detection of cancer, 

8 and modifications to the tests and procedures, with 

9 such frequency, as the Secretary determines to be 

10 appropriate, in consultation with appropriate organi11 zations and agencies, for the diagnosis or detection 

12 of cancer. 

13 ‘‘(b) PROHIBITIONS.—A group health plan, and a 

14 health insurance issuer offering group health insurance 

15 coverage in connection with a group health plan, may 

16 not—

17 ‘‘(1) deny to an individual eligibility, or contin18 ued eligibility, to enroll or to renew coverage under 

19 the terms of the plan, solely for the purpose of 

20 avoiding the requirements of this section; 

21 ‘‘(2) provide monetary payments or rebates to 

22 individuals to encourage such individuals to accept 

23 less than the minimum protections available under 

24 this section; 
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•HR 2741 IH 

1 ‘‘(3) penalize or otherwise reduce or limit the 

2 reimbursement of a provider because such provider 

3 provided care to an individual participant or bene4 ficiary in accordance with this section; or 

5 ‘‘(4) provide incentives (monetary or otherwise) 

6 to a provider to induce such provider to provide care 

7 to an individual participant or beneficiary in a man8 ner inconsistent with this section. 

9 ‘‘(c) RULES OF CONSTRUCTION.—

10 ‘‘(1) Nothing in this section shall be construed 

11 to require an individual who is a participant or bene12 ficiary to undergo a procedure, examination, or test 

13 described in subsection (a). 

14 ‘‘(2) Nothing in this section shall be construed 

15 as preventing a group health plan or issuer from im16 posing deductibles, coinsurance, or other cost-shar17 ing in relation to benefits described in subsection (a) 

18 consistent with such subsection, except that such co19 insurance or other cost-sharing shall not discrimi20 nate on any basis related to the coverage required 

21 under this section. 

22 ‘‘(3) Nothing in this section shall be construed 

23 to result in a reduction, diminishment, or change in 

24 coverage resulting in less coverage. 
101

•HR 2741 IH 

1 ‘‘(d) NOTICE UNDER GROUP HEALTH PLAN.—The 

2 imposition of the requirement of this section shall be treat3 ed as a material modification in the terms of the plan de4 scribed in section 102(a), for purposes of assuring notice 

5 of such requirements under the plan; except that the sum6 mary description required to be provided under the last 

7 sentence of section 104(b)(1) with respect to such modi8 fication shall be provided by not later than 60 days after 

9 the first day of the first plan year in which such require10 ment apply. 

11 ‘‘(e) RISK DEFINED.—For purposes of this section, 

12 an individual is considered to be at ‘risk’ of developing 

13 a particular type of cancer if, under guidelines developed 

14 or recognized by the Secretary based upon scientific evi15 dence, the individual—

16 ‘‘(1) has 1 or more first degree family members 

17 who have developed that type of cancer; 

18 ‘‘(2) has previously had that type of cancer; 

19 ‘‘(3) has the presence of an appropriate recog20 nized gene marker that is identified as putting the 

21 individual at a higher risk of developing that type of 

22 cancer; or 

23 ‘‘(4) has other predisposing or environmental 

24 risk factors that significantly increases the risk of 

25 the individual contracting that type of cancer.
102

•HR 2741 IH 

1 For purposes of this subsection, the term ‘type of cancer’ 

2 includes other types of cancer that the Secretary recog3 nizes as closely related for purposes of establishing risk. 

4 ‘‘SEC. 716. PATIENT ACCESS TO INFORMATION. 

5 ‘‘(a) DISCLOSURE REQUIREMENT.—A group health 

6 plan, and health insurance issuer offering group health in7 surance coverage shall—

8 ‘‘(1) provide to participants and beneficiaries at 

9 the time of initial coverage under the plan (or the 

10 effective date of this section, in the case of individ11 uals who are participants or beneficiaries as of such 

12 date), and at least annually thereafter, the informa13 tion described in subsection (b) in printed form; 

14 ‘‘(2) provide to participants and beneficiaries, 

15 within a reasonable period (as specified by the ap16 propriate Secretary) before or after the date of sig17 nificant changes in the information described in sub18 section (b), information in printed form regarding 

19 such significant changes; and 

20 ‘‘(3) upon request, make available to partici21 pants and beneficiaries, the applicable authority, and 

22 prospective participants and beneficiaries, the infor23 mation described in subsection (b) in printed form. 

24 ‘‘(b) INFORMATION PROVIDED.—The information de25 scribed in subsection (a) that shall be disclosed includes 
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•HR 2741 IH 

1 the following, as such relates to cancer screening required 

2 under section 715(a): 

3 ‘‘(1) BENEFITS.—Benefits offered under the 

4 plan or coverage, including—

5 ‘‘(A) covered benefits, including benefit 

6 limits and coverage exclusions; 

7 ‘‘(B) cost-sharing, such as deductibles, co8 insurance, and copayment amounts, including 

9 any liability for balance billing, any maximum 

10 limitations on out of pocket expenses, and the 

11 maximum out of pocket costs for services that

12 are provided by nonparticipating providers or 

13 that are furnished without meeting the applica14 ble utilization review requirements; 

15 ‘‘(C) the extent to which benefits may be 

16 obtained from nonparticipating providers; and 

17 ‘‘(D) the extent to which a participant, 

18 beneficiary, or enrollee may select from among 

19 participating providers and the types of pro20 viders participating in the plan or issuer net21 work. 

22 ‘‘(2) ACCESS.—A description of the following: 

23 ‘‘(A) The number, mix, and distribution of 

24 providers under the plan or coverage.
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•HR 2741 IH 

1 ‘‘(B) Out-of-network coverage (if any) pro2 vided by the plan or coverage. 

3 ‘‘(C) Any point-of-service option (including 

4 any supplemental premium or cost-sharing for 

5 such option). 

6 ‘‘(D) The procedures for participants, 

7 beneficiaries, and enrollees to select, access, and 

8 change participating primary and specialty pro9 viders. 

10 ‘‘(E) The rights and procedures for obtain11 ing referrals (including standing referrals) to 

12 participating and nonparticipating providers. 

13 ‘‘(F) The name, address, and telephone 

14 number of participating health care providers 

15 and an indication of whether each such provider 

16 is available to accept new patients. 

17 ‘‘(G) How the plan or issuer addresses the 

18 needs of participants, beneficiaries, and enroll19 ees and others who do not speak English or 

20 who have other special communications needs in 

21 accessing providers under the plan or coverage, 

22 including the provision of information under 

23 this subsection.’’. 

24 (B) TECHNICAL AMENDMENTS.—
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•HR 2741 IH 

1 (i) Section 731(c) of the Employee 

2 Retirement Income Security Act of 1974 

3 (29 U.S.C. 1191(c)) is amended by strik4 ing ‘‘section 711’’ and inserting ‘‘sections 

5 711 and 715’’. 

6 (ii) Section 732(a) of the Employee 

7 Retirement Income Security Act of 1974 

8 (29 U.S.C. 1191a(a)) is amended by strik9 ing ‘‘section 711’’ and inserting ‘‘sections 

10 711 and 715’’. 

11 (iii) The table of contents in section 1 

12 of the Employee Retirement Income Secu13 rity Act of 1974, as amended by section 

14 302, is further amended by inserting after 

15 the item relating to section 714 the fol16 lowing new items:

‘‘Sec. 715. Coverage of cancer screening. 

‘‘Sec. 716. Patient access to information.’’.

17 (b) INDIVIDUAL HEALTH INSURANCE.—

18 (1) IN GENERAL.—Part B of title XXVII of the 

19 Public Health Service Act is amended by inserting 

20 after section 2753, as added by section 301(b), the 

21 following new section:
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1 ‘‘SEC. 2754. STANDARD RELATING PATIENT FREEDOM OF 

2 CHOICE. 

3 ‘‘(a) IN GENERAL.—The provisions of section 2708 

4 (other than subsection (d)) shall apply to health insurance 

5 coverage offered by a health insurance issuer in the indi6 vidual market with respect to an enrollee under such cov7 erage in the same manner as they apply to health insur8 ance coverage offered by a health insurance issuer in con9 nection with a group health plan in the small or large 

10 group market to a participant or beneficiary in such plan. 

11 ‘‘(b) NOTICE.—A health insurance issuer under this 

12 part shall comply with the notice requirement under sec13 tion 715(d) of the Employee Retirement Income Security 

14 Act of 1974 with respect to the requirements referred to 

15 in subsection (a) as if such section applied to such issuer 

16 and such issuer were a group health plan. 

17 ‘‘SEC. 2755. PATIENT ACCESS TO INFORMATION. 

18 ‘‘The provisions of section 2709 shall apply health in19 surance coverage offered by a health insurance issuer in 

20 the individual market with respect to an enrollee under 

21 such coverage in the same manner as they apply to health 

22 insurance coverage offered by a health insurance issuer 

23 in connection with a group health plan in the small or 

24 large group market to a participant or beneficiary in such 

25 plan.’’.
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1 (2) TECHNICAL AMENDMENT.—Section 

2 2762(b)(2) of such Act (42 U.S.C. 300gg–62(b)(2)) 

3 is amended by striking ‘‘section 2751’’ and inserting 

4 ‘‘sections 2751 and 2754’’. 

5 (c) EFFECTIVE DATES.—

6 (1) GROUP HEALTH PLANS.—Subject to para7 graph (3), the amendments made by subsection (a) 

8 shall apply with respect to group health plans for 

9 plan years beginning on or after January 1, 2004. 

10 (2) INDIVIDUAL PLANS.—The amendment made 

11 by subsection (b) shall apply with respect to health 

12 insurance coverage offered, sold, issued, renewed, in 

13 effect, or operated in the individual market on or 

14 after such date. 

15 (3) COLLECTIVE BARGAINING AGREEMENT.—In 

16 the case of a group health plan maintained pursuant 

17 to 1 or more collective bargaining agreements be18 tween employee representatives and 1 or more em19 ployers ratified before the date of enactment of this 

20 Act, the amendments made to subsection (a) shall 

21 not apply to plan years beginning before the later 

22 of—

23 (A) the date on which the last collective 

24 bargaining agreements relating to the plan ter25 minates (determined without regard to any ex-
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1 tension thereof agreed to after the date of en2 actment of this Act), or 

3 (B) January 1, 2004. 

4 For purposes of subparagraph (A), any plan amend5 ment made pursuant to a collective bargaining 

6 agreement relating to the plan which amends the 

7 plan solely to conform to any requirement added by 

8 subsection (a) shall not be treated as a termination 

9 of such collective bargaining agreement. 

10 (d) COORDINATED REGULATIONS.—Section 104(1) 

11 of the Health Insurance Portability and Accountability 

12 Act of 1996 (Public Law 104–191) is amended by striking 

13 ‘‘this subtitle (and the amendments made by this subtitle 

14 and section 401)’’ and inserting ‘‘the provisions of part 

15 7 of subtitle B of title I of the Employee Retirement In16 come Security Act of 1974, the provisions of parts A and

17 C of title XXVII of the Public Health Service Act, and 

18 chapter 100 of the Internal Revenue Code of 1986’’. 

19 (e) MODIFICATION OF COVERAGE.—

20 (1) IN GENERAL.—The Secretary of Health and 

21 Human Services may modify the coverage require22 ments for the amendments under this subtitle to 

23 allow such requirements to incorporate and reflect 

24 new scientific and technological advances regarding 

25 cancer screening, practice pattern changes in such 
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1 screening, or other updated medical practices re2 garding such screening, such as the use of new tests 

3 or other emerging technologies. Such modifications 

4 shall not in any way diminish the coverage require5 ments listed under this subtitle. Such modifications 

6 may be made on the Secretary’s own initiative or 

7 upon petition to the Secretary by an individual or 

8 organization. 

9 (2) CONSULTATION.—In modifying coverage re10 quirements under paragraph (1), the Secretary of 

11 Health and Human Services shall consult with ap12 propriate organizations, experts, and agencies. 

13 (3) PETITIONS.—The Secretary of Health and 

14 Human Services may issue requirements for the pe15 titioning process under paragraph (1), including re16 quirements that the petition be in writing and in17 clude scientific or medical bases for the modification 

18 sought. Upon receipt of such a petition, the Sec19 retary shall respond to the petitioner and decide 

20 whether to propose a regulation proposing a change 

21 within 90 days of such receipt. If a regulation is re22 quired, the Secretary shall propose such regulation 

23 within 6 months of such determination. The Sec24 retary shall provide the petitioner the reasons for 

25 the decision of the Secretary. The Secretary may
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1 make changes requested by a petitioner in whole or 

2 in part. 

3 Subtitle C—Physicians and Quality 

4 of Care 

5 SEC. 321. MANAGING PHYSICIANS AND QUALITY OF CARE 

6 FOR CANCER PATIENTS UNDER THE PUBLIC 

7 HEALTH SERVICE ACT. 

8 (a) GROUP.—Subpart 2 of part A of title XXVII of 

9 the Public Health Service Act (42 U.S.C. 300gg–4 et 

10 seq.), as amended by sections 301 and 311, is further 

11 amended by adding at the end the following: 

12 ‘‘SEC. 2710. MANAGING PHYSICIANS AND QUALITY OF CARE 

13 FOR CANCER PATIENTS. 

14 ‘‘(a) MANAGING PHYSICIAN.—A group health plan, 

15 or health insurance issuer that is providing health insur16 ance coverage, shall ensure that with respect to items or 

17 services provided under the plan or coverage relating to 

18 the treatment of cancer, a lead managing physician be des19 ignated at the time of diagnosis by the provider and paid 

20 a bonus by the plan, in consultation with the participant 

21 or beneficiary, and other providers involved to provide for 

22 the overall coordination and management of the cancer 

23 care of the participant or beneficiary among all providers 

24 who provide items or services to the participant or bene25 ficiary and paid for overall coordination of services. 
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1 ‘‘(b) QUALITY OF CARE.—A group health plan, or 

2 health insurance issuer that is providing health insurance 

3 coverage, shall require that all participating health care 

4 professionals who provide primary care cancer services fol5 low the most current quality-of-care cancer care guide6 lines, as developed by medical professionals with expertise 

7 in the field of medicine for which the guidelines are de8 signed and widely recognized as medically necessary and 

9 appropriate. 

10 ‘‘(c) PROHIBITIONS.—A group health plan, and a 

11 health insurance issuer offering group health insurance 

12 coverage in connection with a group health plan, shall 

13 not—

14 ‘‘(1) deny to an individual eligibility, or contin15 ued eligibility, to enroll or to renew coverage under 

16 the terms of the plan, solely for the purpose of 

17 avoiding the requirements of this section; 

18 ‘‘(2) provide monetary payments or rebates to 

19 individuals to encourage such individuals to accept 

20 less than the minimum protections available under 

21 this section; 

22 ‘‘(3) penalize or otherwise reduce or limit the 

23 reimbursement of a provider because such provider 

24 provided care to an individual participant or bene25 ficiary in accordance with this section; or
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1 ‘‘(4) provide incentives (monetary or otherwise) 

2 to a provider to induce such provider to provide care 

3 to an individual participant or beneficiary in a man4 ner inconsistent with this section. 

5 ‘‘(d) RULES OF CONSTRUCTION.—Nothing in this 

6 section shall be construed as preventing a group health 

7 plan or issuer from imposing deductibles, coinsurance, or 

8 other cost-sharing in relation to benefits described in sub9 sections (a) or (b) consistent with such subsections, except 

10 that such coinsurance or other cost-sharing shall not dis11 criminate on any basis related to the coverage required 

12 under this section. 

13 ‘‘(e) NOTICE.—A group health plan under this part 

14 shall comply with the notice requirement under section 

15 714(d) of the Employee Retirement Income Security Act 

16 of 1974 with respect to the requirements of this section 

17 as if such section applied to such plan.’’. 

18 (b) INDIVIDUAL.—Part B of title XXVII of the Pub19 lic Health Service Act is amended by inserting after sec20 tion 2755, as added by section 311, the following: 

21 ‘‘SEC. 2756. MANAGING PHYSICIANS AND QUALITY OF CARE 

22 FOR CANCER PATIENTS. 

23 ‘‘The provisions of section 2710 shall apply to health 

24 insurance coverage offered by a health insurance issuer 

25 in the individual market in the same manner as such pro-
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1 visions apply to health insurance coverage offered by a 

2 health insurance issuer in connection with a group health 

3 plan.’’. 

4 SEC. 322. MANAGING PHYSICIANS AND QUALITY OF CARE 

5 FOR CANCER PATIENTS UNDER THE EM6 PLOYEE RETIREMENT INCOME SECURITY 

7 ACT OF 1974. 

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

9 B of title I of the Employee Retirement Income Security 

10 Act of 1974 (29 U.S.C. 1185 et seq.), as amended by sec11 tions 302 and 311, is further amended by adding at the 

12 end the following:

13 ‘‘SEC. 717. MANAGING PHYSICIANS AND QUALITY OF CARE 

14 FOR CANCER PATIENTS. 

15 ‘‘(a) MANAGING PHYSICIAN.—A group health plan, 

16 or health insurance issuer that is providing health insur17 ance coverage, shall ensure that with respect to items or 

18 services provided under the plan or coverage relating to 

19 the treatment of cancer, a lead managing physician be des20 ignated at the time of diagnosis by the participant or bene21 ficiary involved to provide for the overall coordination and 

22 management of the cancer care of the participant or bene23 ficiary among all providers who provide items or services 

24 to the participant or beneficiary and paid for overall co25 ordination of services. 
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1 ‘‘(b) QUALITY OF CARE.—A group health plan, or 

2 health insurance issuer that is providing health insurance 

3 coverage, shall require that all participating health care 

4 professionals who provide primary care cancer services fol5 low the most current quality-of-care cancer care guide6 lines, as developed by medical professionals with expertise 

7 in the field of medicine for which the guidelines are de8 signed and widely recognized as medically necessary and 

9 appropriate. 

10 ‘‘(c) PROHIBITIONS.—A group health plan, and a 

11 health insurance issuer offering group health insurance 

12 coverage in connection with a group health plan, shall 

13 not—

14 ‘‘(1) deny to an individual eligibility, or contin15 ued eligibility, to enroll or to renew coverage under 

16 the terms of the plan, solely for the purpose of 

17 avoiding the requirements of this section; 

18 ‘‘(2) provide monetary payments or rebates to 

19 individuals to encourage such individuals to accept 

20 less than the minimum protections available under 

21 this section; 

22 ‘‘(3) penalize or otherwise reduce or limit the 

23 reimbursement of a provider because such provider 

24 provided care to an individual participant or bene25 ficiary in accordance with this section; or 
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1 ‘‘(4) provide incentives (monetary or otherwise) 

2 to a provider to induce such provider to provide care 

3 to an individual participant or beneficiary in a man4 ner inconsistent with this section. 

5 ‘‘(d) RULES OF CONSTRUCTION.—Nothing in this 

6 section shall be construed as preventing a group health 

7 plan or issuer from imposing deductibles, coinsurance, or 

8 other cost-sharing in relation to benefits described in sub9 sections (a) or (b) consistent with such subsections, except 

10 that such coinsurance or other cost-sharing shall not dis11 criminate on any basis related to the coverage required 

12 under this section. 

13 ‘‘(e) NOTICE.—A group health plan under this part 

14 shall comply with the notice requirement under section 

15 714(d) of the Employee Retirement Income Security Act 

16 of 1974 with respect to the requirements of this section 

17 as if such section applied to such plan.’’. 

18 (b) CONFORMING AMENDMENT.—The table of con19 tents in section 1 of the Employee Retirement Income Se20 curity Act of 1974, as amended by sections 302 and 311, 

21 is further amended by inserting after the item relating to 

22 section 716 the following new item:

‘‘Sec. 717. Managing physicians and quality of care for cancer patients.’’.
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1 SEC. 323. MANAGING PHYSICIANS AND QUALITY OF CARE 

2 FOR CANCER PATIENTS UNDER MEDICARE. 

3 (a) APPLICATION OF CANCER COVERAGE REQUIRE4 MENTS.—Part B of title XVIII of the Social Security Act 

5 (42 U.S.C. 1395j et seq.) is amended by adding at the 

6 end the following: 

7 ‘‘APPLICATION OF CANCER COVERAGE REQUIREMENTS

8 ‘‘SEC. 1849. The provisions of sections 2707, 2708, 

9 and 2710 of the Public Health Service Act shall apply to 

10 an individual who has been diagnosed with cancer and who 

11 is covered under the insurance program established under 

12 this part.’’. 

13 (b) ADDITIONAL PAYMENT.—Section 1833(m) of the 

14 Social Security Act (42 U.S.C. 1395l(m)) is amended—

15 (1) by inserting ‘‘(1)’’ after ‘‘(m)’’; and 

16 (2) by adding at the end the following new 

17 paragraph: 

18 ‘‘(2) In the case of physicians’ services furnished to 

19 an individual who has been diagnosed with cancer, who 

20 is covered under the insurance program established under 

21 this part who receives care for such cancer from a team 

22 of physicians, and who incurs expenses for physicians’ 

23 services that are related to that diagnosis, there shall be 

24 paid to the physician designated by such team of physi25 cians at the time of diagnosis of the individual as the phy26 sician responsible for the overall coordination and manage-
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1 ment of the medical and other health services provided to 

2 that individual during the period in which that individual 

3 is undergoing treatment for such cancer (or to an em4 ployer or facility in the cases described in subparagraph 

5 (A) of section 1842(b)(6)) (on a monthly or quarterly 

6 basis) from the Federal Supplementary Medical Insurance 

7 Trust Fund a separate and additional payment amount 

8 for the services under this part in addition to any amount 

9 otherwise paid under this part.’’. 

10 SEC. 324. MANAGING PHYSICIANS AND QUALITY OF CARE 

11 FOR CANCER PATIENTS UNDER MEDICAID 

12 AND SCHIP. 

13 (a) MEDICAID.—Section 1902(a) of the Social Secu14 rity Act (42 U.S.C. 1396a(a)) is amended—

15 (1) in paragraph (64), by striking ‘‘and’’ at the 

16 end; 

17 (2) in paragraph (65), by striking the period 

18 and inserting ‘‘; and’’; and 

19 (3) by inserting after paragraph (65) the fol20 lowing: 

21 ‘‘(66) provide—

22 ‘‘(A) that the provisions of sections 2707, 

23 2708, and 2710 of the Public Health Service 

24 Act shall apply to individuals eligible for med-
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1 ical assistance under the State plan who have 

2 been diagnosed with cancer; and 

3 ‘‘(B) that, in the case of an individual who 

4 has been diagnosed with cancer, who is eligible 

5 for medical assistance under this title, and who 

6 receives care for such cancer from a team of 

7 physicians, and who incurs expenses for physi8 cians’ services that are related to that diag9 nosis, that there shall be paid to the physician 

10 designated by such team of physicians at the 

11 time of diagnosis of the individual as the physi12 cian responsible for the overall coordination and 

13 management of the medical and other health 

14 services provided to that individual during the 

15 period in which that individual is undergoing

16 treatment for such cancer, a separate and addi17 tional payment amount for the services provided 

18 in addition to any amount otherwise paid under 

19 the State plan.’’. 

20 (b) SCHIP.—Section 2103(f) of the Social Security 

21 Act (42 U.S.C. 1397cc(f)) is amended by adding at the 

22 end the following: 

23 ‘‘(3) APPLICATION OF CANCER COVERAGE PRO24 VISIONS.—
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1 ‘‘(A) IN GENERAL.—The provisions of sec2 tions 2707, 2708, and 2710 of the Public 

3 Health Service Act shall apply to the coverage 

4 offered under the State child health plan. 

5 ‘‘(B) ADDITIONAL PAYMENT.—The State 

6 child health plan shall provide in the case of an 

7 individual who has been diagnosed with cancer, 

8 who is eligible for child health assistance under 

9 this title, and who receives care for such cancer 

10 from a team of physicians, and who incurs ex11 penses for physicians’ services that are related 

12 to that diagnosis, that there shall be paid to the 

13 physician designated by such team of physicians 

14 at the time of diagnosis of the individual as the 

15 physician responsible for the overall coordina16 tion and management of the medical and other 

17 health services provided to that individual dur18 ing the period in which that individual is under19 going treatment for such cancer, a separate and 

20 additional payment amount for the services pro21 vided in addition to any amount otherwise paid 

22 under the State child health plan.’’.
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1 Subtitle D—General Provisions 

2 SEC. 331. COVERAGE UNDER OTHER PUBLIC HEALTH IN3 SURANCE. 

4 (a) IN GENERAL.—The coverage described in sub5 section (b) shall be provided for any individual, partici6 pant, or beneficiary who has coverage under—

7 (1) the medicaid program under title XIX of 

8 the Social Security Act (42 U.S.C. 1396 et seq.); 

9 (2) the medicare program under title XVIII of 

10 the Social Security Act (42 U.S.C. 1395 et seq.); 

11 (3) the State Children’s Health Insurance Pro12 gram under title XXI of the Social Security Act (42 

13 U.S.C. 1398 et seq.); 

14 (4) a health plan offered under chapter 89 of 

15 title 5, United States Code; 

16 (5) programs offered by the Department of De17 fense; 

18 (6) a medical care program of the Indian 

19 Health Service or of a tribal organization; and 

20 (7) a health benefit plan under section 5(e) of 

21 the Peace Corps Act (22 U.S.C. 2504(e)). 

22 (b) COVERAGE DESCRIBED.—The coverage described 

23 in this subsection is—

24 (1) the coverage described in section 2708 of 

25 the Public Health Service Act (as added by section
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1 311) for individuals participating in cancer screening 

2 activities; and 

3 (2) the coverage described in section 2710 of 

4 the Public Health Service Act (as added by section 

5 321) for individuals receiving cancer-related items or 

6 services. 

7 (c) APPLICATION TO OTHER HEALTH CARE COV8 ERAGE.—Chapter 89 of title 5, United States Code, is 

9 amended by adding at the end the following: 

10 ‘‘§ 8915. Standards relating to coverage of cancer-re11 lated activities 

12 ‘‘(a) The provisions of sections 2707, 2708, 2709, 

13 and 2710 of the Public Health Service Act shall apply to 

14 the provision of items and services under this chapter. 

15 ‘‘(b) Nothing in this section or section 2707, 2708, 

16 2709, or 2710 of the Public Health Service Act shall be 

17 construed as authorizing a health insurance issuer or enti18 ty to impose cost-sharing with respect to the coverage or 

19 benefits required to be provided under such sections that 

20 is inconsistent with the cost-sharing that is otherwise per21 mitted under this chapter.’’. 
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1 TITLE IV—PATIENT NAVIGATOR 

2 AND CANCER CARE WITHIN 

3 THE HEALTH RESOURCES 

4 AND SERVICES ADMINISTRA5 TION 

6 SEC. 401. HRSA GRANTS FOR MODEL COMMUNITY CANCER 

7 AND CHRONIC DISEASE CARE AND PREVEN8 TION AND GRANTS FOR PATIENT NAVIGA9 TORS. 

10 Subpart I of part D of title III of the Public Health 

11 Service Act (42 U.S.C. 254b et seq.) is amended by adding 

12 at the end the following: 

13 ‘‘SEC. 330M. MODEL COMMUNITY CANCER AND CHRONIC 

14 DISEASE CARE AND PREVENTION; PATIENT 

15 NAVIGATORS. 

16 ‘‘(a) DEFINITIONS.—In this section, the terms ‘‘cul17 turally competent’’, ‘‘appropriate follow-up care’’, ‘‘health 

18 disparity population’’, and ‘‘patient navigator’’ have the 

19 meanings given those terms in section 417E–10. 

20 ‘‘(b) MODEL COMMUNITY CANCER AND CHRONIC

21 DISEASE CARE AND PREVENTION.—

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

23 through the Administrator of the Health Resources 

24 and Services Administration, may make grants to 

25 public and nonprofit private health centers (includ-
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1 ing health centers under section 330, Indian Health 

2 Service Centers, tribal governments, urban Indian 

3 organizations, tribal organizations, clinics serving 

4 Asian Americans and Pacific Islanders and Alaskan 

5 Natives, rural health clinics, and qualified nonprofit 

6 entities that partner with 1 or more centers pro7 viding health care services to provide navigation 

8 services that demonstrate the ability to perform all 

9 of the functions outlined in this subsection and sub10 sections (c) and (d)) for the development and oper11 ation of model programs that perform the same 

12 functions outlined in section 417E–10(b)(1). 

13 ‘‘(2) APPLICATION FOR GRANT.—An entity that 

14 desires to receive a grant under paragraph (1) shall 

15 submit an application to the Secretary at such time, 

16 in such manner, and containing such agreements, 

17 assurances, and information as the Secretary deter18 mines to be necessary to carry out this section. 

19 ‘‘(3) OUTREACH SERVICES.—In order to be eli20 gible to receive a grant under paragraph (1), an en21 tity shall agree to provide ongoing outreach activities 

22 while receiving the grant, in a manner that is cul23 turally competent for the health disparity population

24 served by the program, to inform the public and the 

25 specific community that the program is serving of 
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1 the services of the model program under the grant. 

2 Such activities shall include facilitating access to ap3 propriate health care services and patient navigators 

4 within the health care system to ensure optimal pa5 tient utilization of such services. 

6 ‘‘(4) DATA COLLECTION AND REPORT.—In 

7 order to allow for effective program evaluation, an 

8 entity that receives a grant under this subsection 

9 shall collect specific patient data recording services 

10 provided to each patient served by the program and 

11 shall establish and implement procedures and proto12 cols, consistent with applicable Federal and State 

13 laws (including sections 160 and 164 of title 45, 

14 Code of Federal Regulations) to ensure the confiden15 tiality of all information shared by a participant in 

16 the program, or their personal representative and 

17 their health care providers, group health plans, or 

18 health insurance insurers with the program. The 

19 program may, consistent with applicable Federal and 

20 State confidentiality laws, collect, use, or disclose ag21 gregate information that is not individually identifi22 able (as defined in sections 160 and 164 of title 45, 

23 Code of Federal Regulations). With this data, the 

24 grantee shall submit an annual report to the Sec25 retary that summarizes and analyzes the data and 
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1 provides information on needs for navigation serv2 ices, types of access difficulties resolved, sources of 

3 repeated resolution, and flaws in the system of ac4 cess, including insurance barriers. 

5 ‘‘(5) EVALUATIONS.—

6 ‘‘(A) IN GENERAL.—The Secretary, acting 

7 through the Administrator of the Health Re8 sources and Services Administration, shall, di9 rectly or through grants or contracts, provide 

10 for evaluations to determine which outreach ac11 tivities under paragraph (3) were most effective 

12 in informing the public and the specific commu13 nity that the program is serving of the model 

14 program services and to determine the extent to 

15 which such programs were effective in providing 

16 culturally competent services to the health dis17 parity population served by the programs. 

18 ‘‘(B) DISSEMINATION OF FINDINGS.—The 

19 Secretary shall as appropriate disseminate to 

20 public and private entities the findings made in 

21 evaluations under subparagraph (A). 

22 ‘‘(6) COORDINATION WITH OTHER PRO23 GRAMS.—The Secretary shall coordinate the pro24 gram under this subsection with—

25 ‘‘(A) the program under subsection (c); 
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1 ‘‘(B) the program under section 417E–10 

2 of the Public Health Service Act; and 

3 ‘‘(C) to the extent practicable, programs 

4 for prevention centers that are carried out by 

5 the Director of the Centers for Disease Control 

6 and Prevention. 

7 ‘‘(c) PROGRAM FOR PATIENT NAVIGATORS.—

8 ‘‘(1) IN GENERAL.—The Secretary, acting 

9 through the Administrator of the Health Resources 

10 and Services Administration, may make grants to 

11 public and nonprofit private health centers (includ12 ing health centers under section 330, Indian Health 

13 Service Centers, tribal governments, urban Indian 

14 organizations, tribal organizations, clinics serving 

15 Asian Americans and Pacific Islanders and Alaskan 

16 Natives, rural health clinics, and qualified nonprofit 

17 entities that partner with 1 or more centers pro18 viding health care to provide navigation services, 

19 that demonstrate the ability to perform all of the 

20 functions outlined in this subsection and subsections 

21 (b) and (d)) for the development and operation of 

22 programs to pay the costs of such health centers in 

23 carrying out the same activities outlined in section 

24 417E–10(c)(1).
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1 ‘‘(2) APPLICATION FOR GRANT.—An entity that 

2 desires to receive a grant under paragraph (1) shall 

3 submit an application to the Secretary at such time, 

4 in such manner, and containing such agreements, 

5 assurances, and information as the Secretary deter6 mines to be necessary to carry out this section. 

7 ‘‘(3) OUTREACH SERVICES.—In order to be eli8 gible to receive a grant under paragraph (1), an en9 tity shall agree to provide ongoing outreach activities 

10 while receiving the grant, in a manner that is cul11 turally competent for the health disparity population 

12 served by the program, to inform the public and the 

13 specific community that the patient navigator is 

14 serving of the services of the model program under 

15 the grant. 

16 ‘‘(4) DATA COLLECTION AND REPORT.—In 

17 order to allow for effective patient navigator pro18 gram evaluation, an entity that receives a grant 

19 under this subsection shall collect specific patient 

20 data recording navigation services provided to each 

21 patient served by the program and shall establish 

22 and implement procedures and protocols, consistent 

23 with applicable Federal and State laws (including 

24 sections 160 and 164 of title 45, Code of Federal 

25 Regulations) to ensure the confidentiality of all in-
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•HR 2741 IH 

1 formation shared by a participant in the program, or 

2 their personal representative and their health care 

3 providers, group health plans, or health insurance 

4 insurers with the program. The patient navigator 

5 program may, consistent with applicable Federal and 

6 State confidentiality laws, collect, use, or disclose ag7 gregate information that is not individually identifi8 able (as defined in sections 160 and 164 of title 45, 

9 Code of Federal Regulations). With this data, the 

10 grantee shall submit an annual report to the Sec11 retary that summarizes and analyzes the data and 

12 provides information on needs for navigation serv13 ices, types of access difficulties resolved, sources of 

14 repeated resolution, and flaws in the system of ac15 cess, including insurance barriers. 

16 ‘‘(5) EVALUATIONS.—

17 ‘‘(A) IN GENERAL.—The Secretary, acting 

18 through the Administrator of the Health Re19 sources and Services Administration, shall, di20 rectly or through grants or contracts, provide 

21 for evaluations to determine the effects of the 

22 services of patient navigators on the individuals

23 of health disparity populations for whom the 

24 services were provided, taking into account the 
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1 matters referred to in section 417E–

2 10(c)(1)(C). 

3 ‘‘(B) DISSEMINATION OF FINDINGS.—The 

4 Secretary shall, as appropriate, disseminate to 

5 public and private entities the findings made in 

6 evaluations under subparagraph (A). 

7 ‘‘(6) COORDINATION WITH OTHER PRO8 GRAMS.—The Secretary shall coordinate the pro9 gram under this subsection with the programs under 

10 subsection (b) and section 417E–10. 

11 ‘‘(d) REQUIREMENTS REGARDING FEES.—

12 ‘‘(1) IN GENERAL.—In order to be eligible to 

13 receive a grant under subsection (b) or (c), the pro14 gram for which the grant is made shall have in ef15 fect—

16 ‘‘(A) a schedule of fees or payments for 

17 the provision of such program’s health care 

18 services related to the prevention and treatment 

19 of disease that is consistent with locally pre20 vailing rates or charges and is designed to cover 

21 such program’s reasonable costs of operation; 

22 and 

23 ‘‘(B) a corresponding schedule of discounts 

24 to be applied to the payment of such fees or 
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1 payments, which discounts are adjusted on the 

2 basis of the ability of the patient to pay. 

3 ‘‘(2) RULE OF CONSTRUCTION.—Nothing in 

4 this subsection shall be construed to require pay5 ment for navigation services or to require payment 

6 for health care services in cases where care is pro7 vided free of charge, including the case of services 

8 provided through programs of the Indian Health 

9 Service. 

10 ‘‘(e) MODEL.—Not later than 5 years after the date 

11 of enactment of this section, the Secretary shall develop 

12 a peer-reviewed model of systems for the services provided 

13 by this section. The Secretary shall update such model as 

14 may be necessary to ensure that the best practices are 

15 being utilized. 

16 ‘‘(f) DURATION OF GRANT.—The period during 

17 which payments are made to an entity from a grant under 

18 subsection (b)(1) or (c)(1) may not exceed 5 years. The 

19 provision of such payments are subject to annual approval 

20 by the Secretary and subject to the availability of appro21 priations for the fiscal year involved. Nothing in this sub22 section shall be construed as establishing a limitation on 

23 the number of grants under subsections (b) and (c) that 

24 may be made to an entity. 

25 ‘‘(g) AUTHORIZATION OF APPROPRIATIONS.—
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1 ‘‘(1) IN GENERAL.—

2 ‘‘(A) MODEL PROGRAMS.—For the purpose 

3 of carrying out subsection (b), there are author4 ized to be appropriated such sums as may be 

5 necessary for each of the fiscal years 2004 

6 through 2008. 

7 ‘‘(B) PATIENT NAVIGATORS.—For the pur8 pose of carrying out subsection (c), there are 

9 authorized to be appropriated such sums as 

10 may be necessary for each of the fiscal years 

11 2004 through 2008. 

12 ‘‘(C) BUREAU OF PRIMARY HEALTH

13 CARE.—Amounts appropriated under subpara14 graph (A) or (B) shall be administered through 

15 the Bureau of Primary Health Care. 

16 ‘‘(2) PROGRAMS IN RURAL AREAS.—

17 ‘‘(A) MODEL PROGRAMS.—For the purpose 

18 of carrying out subsection (b) in making grants 

19 under such subsection for model programs in 

20 rural areas, there are authorized to be appro21 priated such sums as may be necessary for each 

22 of the fiscal years 2004 through 2008. 

23 ‘‘(B) PATIENT NAVIGATORS.—For the pur24 pose of carrying out subsection (c) in making 

25 grants under such subsection for programs in 
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1 rural areas, there are authorized to be appro2 priated such sums as may be necessary for each 

3 of the fiscal years 2004 through 2008. 

4 ‘‘(C) OFFICE OF RURAL HEALTH POL5 ICY.—Amounts appropriated under subpara6 graph (A) or (B) shall be administered through 

7 the Office of Rural Health Policy. 

8 ‘‘(3) RELATION TO OTHER AUTHORIZATIONS.—

9 Authorizations of appropriations under paragraphs 

10 (1) and (2) are in addition to other authorizations 

11 of appropriations that are available for the purposes 

12 of carrying out subsections (b) and (c).’’.

Æ