II 

110TH CONGRESS 

1ST SESSION S. 1056 

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 SENATE OF THE UNITED STATES 

MARCH 29, 2007 

Mrs. FEINSTEIN (for herself and Mr. BROWNBACK) introduced the following 

bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions 

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, 

3 SECTION 1. SHORT TITLE; TABLE OF CONTENTS. 

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

5 ‘‘National Cancer Act of 2007’’. 

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

7 this Act is as follows: 

Sec. 1. Short title; table of contents. 

Sec. 2. Findings. 


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TITLE I—EXPANSION OF CANCER-RELATED RESEARCH, 

PREVENTION, DETECTION, AND TREATMENT PROGRAMS 

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

Sec. 102. Sense of the Senate 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. National Center on Minority Health and Health Disparities. 

Sec. 106. Comprehensive cancer control plans. 

Sec. 107. Lung cancer early detection demonstration project. 

Sec. 108. Colorectal cancer screening. 

Sec. 109. National program of cancer registries. 

Sec. 110. Other transactions authority. 

TITLE II—EXPANDING ACCESS TO CANCER DRUGS AND 

TREATMENT 

Sec. 201. Drugs to prevent cancer. 

Sec. 202. Compassionate access to investigational drugs and devices. 

Sec. 203. Oncology Drugs Advisory Committee. 

Sec. 204. Technical amendment. 

TITLE III—PAYMENTS FOR CANCER-RELATED SERVICES AND 

PRODUCTS 

Sec. 301. Coordinating cancer care for patients. 

Sec. 302. Elimination of optional exclusion from medicaid prescription drug 

coverage for tobacco cessation medications. 

TITLE IV—PROMOTING BIOSPECIMEN COLLECTION TO ACCELERATE THE GENOMIC MAPPING OF THE MOST LETHAL CANCERS 

Sec. 401. Adoption of National Cancer Institute guidelines for biorepositories. 

Sec. 402. MedPac report on payments for specimen collection. 

1 SEC. 2. FINDINGS. 

2 Congress makes the following findings: 

3 (1) Cancer killed 6,700,000 people around the 

4 world in 2002 and this figure is expected to rise to 

5 10,100,000 in 2020. 

6 (2) In 2007, an estimated 1,444,920 new can7 cer cases will be diagnosed in the United States. 

8 More than 1,000,000 cases of skin cancer are also 


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1 expected to be diagnosed this year. Cancer accounts 

2 for one in every four deaths, and about 559,650 

3 Americans are expected to die from cancer this year. 

4 Approximately 40 percent of all Americans in the 

5 United States will be diagnosed with cancer at some 

6 point in their lives, 1 of every 2 men and 1 of every 

7 3 women. 

8 (3) The National Institutes of Health estimated 

9 the overall cost of cancer for 2006 at 

10 $206,300,000,000. 

11 (4) Cancer can strike at any age, but it remains 

12 largely a disease of aging. As the American popu13 lation ages, the number of cancer cases will rise. It 

14 is estimated that between 2000 and 2010, the num15 ber of cancer diagnoses will increase by 20 percent 

16 based on this change in population dynamics and no 

17 change in cancer risk. With such increases in the in18 cidence of cancer, not only will costs continue to 

19 grow, but there will be a serious shortage of individ20 uals in the workforce to provide cancer care, particu21 larly in long-term care settings. 

22 (5) Since 1971, when the National Cancer Act 

23 was enacted, and the ‘‘War on Cancer’’ was de24 clared, the science of cancer has advanced dramati25 cally. The revolution in molecular and cellular biolVerDate Aug 31 2005 01:50 Apr 11, 2007 Jkt 059200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\S1056.IS S1056

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1 ogy and advances in technology have created unprec2 edented opportunities for understanding cancer and 

3 the role of genetics, environmental risk factors, and 

4 lifestyle factors in relation to cancer. 

5 (6) Since 1971, mortality rates for some can6 cers have decreased, while such rates for other can7 cers remain high. The United States has seen the 

8 number of cancer deaths drop for 2 consecutive 

9 years, despite an older and larger population. This 

10 success is largely due to reductions in smoking prev11 alence over the past several decades, improvements 

12 in cancer screening rates, and the use of increasingly 

13 effective treatment regimens. 

14 (7) Since 1971, the United States population 

15 has become increasingly diverse and cancer affects 

16 various minority, socioeconomic, and ethnic groups 

17 disproportionately. For example, in 2003, the death 

18 rate from cancer among African American males 

19 was 35 percent higher than that among white males 

20 and for African American females, it was 18 percent 

21 higher than white females. 

22 (8) The quality of cancer care is uneven across 

23 the Nation. Many cancer patients do not receive op24 timal care. 


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1 (9) Cancer is the chief cause of death by dis2 ease in children between the ages of 1 and 14. Each 

3 year, 14,000 children and adolescents are diagnosed 

4 with cancer. However, while nearly every childhood 

5 cancer diagnosis 20 years ago was fatal, today ap6 proximately 80 percent of children diagnosed with 

7 cancer survive at least 5 years. 

8 (10) Survivors of childhood cancer are 5 times 

9 more likely to suffer moderate to severe health prob10 lems in adulthood than their healthy siblings. 

11 (11) Adolescents and young adults diagnosed 

12 with cancer between ages 15 and 39 have seen little 

13 or no improvement in cancer survival rates in dec14 ades and are the least represented population in 

15 clinical trials. Survivors in this age range are at risk 

16 for many long-term adverse treatments effects such 

17 as second primary cancers, heart failure, hearing 

18 loss, and cognitive dysfunction. 

19 (12) Cancers that can be prevented or detected 

20 earlier by screening account for at least half of all 

21 new cancer cases. Screening can detect cancers of 

22 the breast, colon, rectum, cervix, prostate, oral cav23 ity and skin at early stages, resulting in a 5-year 

24 survival rate of about 86 percent, a reflection of real 

25 reductions in mortality as well as earlier diagnosis 


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1 because of screening. Cancer screening rates vary by 

2 cancer site, population group, and health insurance 

3 coverage. 

4 (13) Approximately 10,500,000 cancer sur5 vivors are living in the United States. These sur6 vivors may experience physical, psychological, social 

7 and economic effects as a result of cancer and its 

8 treatment. 

9 (14) About 76 percent of all cancers are diag10 nosed at age 55 and older, and 6 of every 10 cancer 

11 diagnoses are at age 65 and above. Medicare plays 

12 a critical role in providing cancer care for many 

13 Americans. 

14 (15) Scientific advances in cancer treatment 

15 since 1971 have helped shift cancer care, such as the 

16 administration of chemotherapy, increasingly from 

17 inpatient to outpatient settings. 

18 (16) Clinical trials are a critical resource for 

19 the discovery of new prevention, diagnostic, and 

20 treatment methods for cancer. However, only 3 to 5 

21 percent of the nearly 1,400,000 adult cancer pa22 tients each year participate in cancer clinical trials, 

23 contrasted with the 60 percent participation rate of 

24 children with cancer. 


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1 (17) New translational research centers focused 

2 on cancer are needed to provide the preclinical and 

3 early clinical trial support required to advance sci4 entific discoveries into new drugs and technologies to 

5 prevent, detect, treat, and diagnose cancer. 

6 (18) The number of medical researchers is de7 clining, a decrease which will negatively affect the 

8 prevention, detection, and treatment of cancer. 

9 (19) Since 1971, the conduct of research has 

10 involved more collaboration between public and pri11 vate sectors and more multidisciplinary approaches. 

12 The biotechnology pharmaceutical and device indus13 tries have grown and provided a broad array of pre14 vention, detection, and treatment approaches and 

15 scientific opportunities for cancer patients, pro16 viders, and researchers. 

17 (20) In May 2001, Gleevec, the first in what is 

18 expected to be a number of targeted cancer treat19 ments, was approved for use by the Food and Drug 

20 Administration. It appeared to be effective in stop21 ping the growth of deadly Chronic Myeloid Leu22 kemia cells within 3 months of use. In 2002, Gleevec 

23 showed ability to stop growth of gastrointestinal 

24 stromal tumors. Trials have now demonstrated that 


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1 89 percent of CML patients taking Gleevec are alive 

2 5 years after diagnosis. 

3 (21) Other targeted cancer therapies, such as 

4 Avastin, Tarceva, and Herceptin are emerging as 

5 promising cancer treatments. 

6 (22) In 2006, the Food and Drug Administra7 tion approved the first vaccine to prevent the two 

8 strains of Human Papillomavirus (HPV) responsible 

9 for 70 percent of cervical cancer cases. 

10 (23) Tobacco use is the leading preventable 

11 cause of disease and premature death in the United 

12 States, resulting in approximately 1/3 of all cancer 

13 deaths, including 87 percent of lung cancer deaths. 

14 Smoking alone causes more than $167,000,000 in 

15 annual health related costs. 

16 (24) The development of molecular technology 

17 and chemopreventative agents to attack 

18 precancerous cells before they develop into tumors is 

19 a promising way to reduce cancer incidence and 

20 death rates. 


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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 SENATE CONCERNING INVEST6 MENTS IN CANCER RESEARCH FUNDING. 

7 It is the sense of the Senate that— 

8 (1) past investments in cancer research have re9 sulted in better health, an improved quality of life, 

10 and new discoveries; and 

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

12 between 1998 and 2003 during which Congress dou13 bled the budget at the National Institutes of Health, 

14 the National Cancer Institute requires continued 

15 Federal investment, as outlined in the National Can16 cer Institute Directors Bypass Budget: The Nation’s 

17 Investment in Cancer, to achieve a balanced research 

18 portfolio and to develop more targeted, more effec19 tive therapies or drugs and other cancer treatments 

20 and to address those rare, deadly cancers lacking ef21 fective early detection tests or treatments for a wide 

22 range of cancers, commensurable with the National 

23 Cancer Institute bypass budget. 


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1 SEC. 102. SENSE OF THE SENATE CONCERNING INVEST2 MENTS IN CANCER RESEARCH TO DEVELOP 

3 TARGETED DRUGS. 

4 (a) FINDINGS.—The Senate finds that— 

5 (1) all cells have molecular signatures, unique 

6 identifiable characteristics related to a cells’ function 

7 in the body; 

8 (2) as a normal cell becomes malignant, its sig9 nature changes and this change becomes a signal of 

10 the presence of cancer; and 

11 (3) with new technologies, scientists are reading 

12 cancer-associated signatures and using this informa13 tion to devise treatments that target specific cells. 

14 (b) SENSE OF THE SENATE.—It is the sense of the 

15 Senate that to build on the research currently conducted 

16 by the National Institutes of Health, continued funding 

17 is necessary to further develop this new generation of low 

18 toxicity, high efficacy agents which target only the cancer 

19 cells leaving in place the healthy cells. 

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

21 PREVENTION, DETECTION, TREATMENT, AND 

22 SURVIVORSHIP PROGRAMS. 

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

24 Service Act (42 U.S.C. 285) is amended— 

25 (1) by inserting after the subpart heading the 

26 following: 


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1 ‘‘CHAPTER I—PURPOSE OF INSTITUTE 

2 AND NATIONAL CANCER PROGRAMS’’; 

3 and 

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

5 ‘‘CHAPTER II—PROGRAMS TO PREVENT 

6 AND TREAT CANCER 

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

8 ‘‘(a) IN GENERAL.—Not later than 6 months after 

9 the date of enactment of the National Cancer Act of 2007, 

10 the Institute shall prepare a progress report on the goal 

11 of reducing death and suffering from cancer in the next 

12 10 years, that identifies unmet needs, recommends 

13 progress goals and benchmarks, recommends pro14 grammatic restructuring, and recommends a level of fund15 ing necessary in the following areas: 

16 ‘‘(1) Understanding the causes of cancer. 

17 ‘‘(2) Research regarding cancer prevention. 

18 ‘‘(3) Improving early detection and diagnosis of 

19 cancer. 

20 ‘‘(4) Developing effective and efficient cancer 

21 treatments. 

22 ‘‘(5) Understanding the factors that influence 

23 patient outcomes. 

24 ‘‘(6) Improving the quality of cancer care. 


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1 ‘‘(7) Research regarding the quality of life for 

2 cancer patients and survivors. 

3 ‘‘(8) Overcoming cancer health disparities. 

4 ‘‘(b) DETAILED REPORT.—The Institute shall in5 clude in future reports to Congress an accounting for the 

6 manner in which Congressional funding for cancer activi7 ties described in subsection (a) was used during the 5- 

8 fiscal year period preceding the date of enactment of the 

9 National Cancer Act of 2007, that includes a detailed de10 scription of the type of cancer and the treatment, device, 

11 tool, or discovery that was procured and the estimated 

12 number of individuals with cancer who benefitted from 

13 such activities. 

14 ‘‘(c) PRIORITIES.—Not later than 6 months after the 

15 date of enactment of the National Cancer Act of 2007, 

16 the Institute shall determine priorities based on scientific 

17 opportunities, in consultation with medical, scientific, pa18 tient, and provider representatives, and prepare 1 or more 

19 strategic plans. 

20 ‘‘SEC. 417E–1. GRANTS FOR DEVELOPMENT OF TARGETED 

21 DRUGS. 

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

23 shall carry out a research grant program to provide fund24 ing to projects that seek to develop cancer treatments that 

25 target cancer cells. 


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

2 program under subsection (a), the Director of the Insti3 tute shall— 

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

5 award grants to public or nonprofit private entities 

6 to conduct research to develop a molecularly-ori7 ented, knowledge-based approach to cancer drug dis8 covery and development; and 

9 ‘‘(2) not later than 6 months after the date of 

10 enactment of the National Cancer Act of 2007, de11 velop and implement a strategic plan for intensifying 

12 and expanding research conducted to increase the 

13 number of cancer treatments available that are low 

14 toxicity, high efficacy agents, and in particular, re15 search to develop treatments that selectively target 

16 malignant or cancerous cells. 

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

18 under this section shall not be used for the construction 

19 of facilities. 

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 2008 through 2011. 


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1 ‘‘SEC. 417E–2. CLINICAL TRIALS. 

2 ‘‘(a) IN GENERAL.—For the purpose of enhancing 

3 patient access to clinical trials and investigational thera4 pies for the treatment or prevention of cancer, the Na5 tional Cancer Institute shall establish an education pro6 gram that provides patients and providers with— 

7 ‘‘(1) information about how to access and use 

8 the National Cancer Institute clinical trials database 

9 online; 

10 ‘‘(2) information about the Food and Drug Ad11 ministration process for approving the use of drugs 

12 and biologics for a single patient; 

13 ‘‘(3) information targeted to populations of age 

14 and cultural demographics that are frequently 

15 underrepresented in clinical trials; and 

16 ‘‘(4) recommendations regarding logistical sup17 port and sources of funding for patients support 

18 costs. 

19 ‘‘(b) INFORMATION DISSEMINATION.—In carrying 

20 out such information dissemination described under this 

21 section, the Director of the Institute shall regularly pro22 vide information to cancer care providers, professional and 

23 patient organizations, including community-based organi24 zations, and patients to increase provider participation 

25 and patient enrollment in clinical trials. 


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1 ‘‘(c) DIVERSITY ASSURANCE.—The Director of the 

2 Institute shall require that all research grant applications 

3 include assurances that the applicant will actively recruit 

4 a diverse patient population, including disparity popu5 lations, to participate in trials, when such recruitment is 

6 medically appropriate. 

7 ‘‘(d) SENSE OF THE SENATE ON A CENTRAL INSTI8 TUTIONAL REVIEW BOARD.—It is the sense of the Senate 

9 that— 

10 ‘‘(1) the current procedure of sending 1 clinical 

11 trial through multiple local institutional review 

12 boards may not be the most efficient method for the 

13 protection of patients enrolled in the trial and may 

14 delay the process of bringing lifesaving treatment to 

15 cancer patients; 

16 ‘‘(2) the National Cancer Institute should be 

17 commended for its work in centralizing the institu18 tional review board process and should continue to 

19 recommend and support meaningful reform of the 

20 existing Central Institutional Review Board Initia21 tive; and 

22 ‘‘(3) the research community should continue to 

23 streamline the institutional review board process in 

24 order to bring lifesaving treatments to patients as 

25 quickly as possible. 


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1 ‘‘SEC. 417E–3. CANCER CARE RESEARCHERS. 

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

3 to ensure a sufficient number of researchers who are 

4 trained in the prevention, early detection, diagnosis, cure, 

5 and treatment of cancer in future fiscal years, the Director 

6 of the Institute, in coordination with the Secretary of Vet7 erans Affairs and the National Institute of Nursing Re8 search, shall conduct a study as described in section 

9 417E–4 for the purpose of recommending activities to pro10 mote training and education for health care professionals 

11 and institutions supporting cancer research. 

12 ‘‘(b) LOAN REPAYMENT.— 

13 ‘‘(1) IN GENERAL.—The Director of the Insti14 tute shall establish a program of entering into con15 tracts with qualified health professionals under 

16 which such health professionals agree to engage in 

17 cancer prevention research in consideration of the 

18 Federal Government agreeing to repay, for each year 

19 of engaging in such research, not more than 

20 $35,000 of the principal and interest of the edu21 cational loans of such health professionals. 

22 ‘‘(2) SERVICE PROVISIONS.—The provisions of 

23 sections 338B, 338C, and 338E shall, except as in24 consistent with paragraph (1), apply to the program 

25 established in such paragraph to the same extent 

26 and in the same manner as such provisions apply to 


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1 the National Health Service Corps Loan Repayment 

2 Program established in subpart III of part D of title 

3 III. 

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

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

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

7 2008 through 2011. 

8 ‘‘SEC. 417E–4. CANCER CARE WORKFORCE. 

9 ‘‘(a) IN GENERAL.— 

10 ‘‘(1) STUDY.—The Secretary shall conduct a 

11 study on the current and future cancer care work12 force needs in the following areas: 

13 ‘‘(A) Cancer research. 

14 ‘‘(B) Care and treatment of cancer pa15 tients and survivors. 

16 ‘‘(C) Quality of life, symptom manage17 ment, and pain management. 

18 ‘‘(D) Early detection and diagnosis. 

19 ‘‘(E) Cancer prevention. 

20 ‘‘(F) Genetic testing, counseling, and eth21 ical considerations related to such testing. 

22 ‘‘(G) Diversity and appropriate care for 

23 disparity populations. 

24 ‘‘(H) Palliative and end-of-life care. 


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1 ‘‘(2) REPORT.—Not later than 1 year after the 

2 date of enactment of the National Cancer Act of 

3 2007, the Secretary shall submit to Congress a re4 port that describes the findings of the study con5 ducted under subsection (a). 

6 ‘‘(b) PROGRAM.— 

7 ‘‘(1) ESTABLISHMENT.—The Secretary shall 

8 issue programmatic recommendations and establish 

9 a program to carry out activities based on the re10 sults of the study conducted under subsection (a). 

11 ‘‘(2) RECOMMENDATIONS.—The programmatic 

12 recommendations described in paragraph (1) shall— 

13 ‘‘(A) set annual and long-term training 

14 goals to assure an adequate cancer care work15 force; 

16 ‘‘(B) prepare and implement a plan to as17 sist to cancer healthcare professions with the 

18 most severe shortages, under which awards will 

19 be made under this section to eligible individ20 uals to increase cancer care workforce training 

21 for individuals to become cancer care providers, 

22 which may include such individuals who make a 

23 commitment to serve in underserved commu24 nities or areas with disproportionately high can25 cer incidence or mortality and for health profesVerDate Aug 31 2005 01:50 Apr 11, 2007 Jkt 059200 PO 00000 Frm 00018 Fmt 6652 Sfmt 6201 E:\BILLS\S1056.IS S1056

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1 sions for which there are anticipated shortages; 

2 and 

3 ‘‘(C) be coordinated with existing programs 

4 to prevent duplication. 

5 ‘‘(c) ELIGIBILITY.—To be eligible to receive assist6 ance under this section, an individual shall submit an ap7 plication to the Secretary at such time, in such manner, 

8 and containing such information as the Secretary reason9 ably requires. In such application, such individual shall 

10 demonstrate the intent to seek training to obtain a certifi11 cate, license, or postsecondary degree as the Secretary 

12 provides in the report under subsection (a), or in the case 

13 of licensed health care professionals, the intent to seek 

14 professional development to upgrade skills and knowledge 

15 or to obtain specialized knowledge according to criteria de16 veloped by the Secretary. 

17 ‘‘(d) USE OF FUNDS.—The use of funds by a recipi18 ent of assistance under this section shall be deemed by 

19 the Secretary and reported to Congress not later than 1 

20 year after the issuance of the report under subsection (a). 

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

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

23 such sums as may be necessary in each year for each of 

24 fiscal years 2008 through and 2011. 


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1 ‘‘SEC. 417F–5. CANCER SURVIVORSHIP. 

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

3 the Director of the National Cancer Institute, shall con4 duct a study of the unique health challenges associated 

5 with cancer survivorship and carry out projects and inter6 ventions to improve the long-term health status of cancer 

7 survivors. Such projects shall be carried out directly or 

8 through the awarding of grants or contracts. 

9 ‘‘(b) ACTIVITIES.—Activities that may be carried out 

10 under subsection (a) include— 

11 ‘‘(1) the coordination of a partnership between 

12 the National Cancer Institute and the Centers for 

13 Disease Control and Prevention to assess the unique 

14 challenges associated with cancer survivorship and 

15 the enhancement of cancer related surveillance sys16 tems to track the status of cancer survivors and de17 termine whether cancer survivors are at-risk for 

18 other chronic and disabling conditions; 

19 ‘‘(2) the development of a national cancer survi20 vorship action plan, in partnership with health orga21 nizations focused on cancer survivorship, including 

22 further support for the Childhood Cancer Survivors 

23 Study, to be carried out in coordination with the 

24 State-based comprehensive cancer control program 

25 of the Centers for Disease Control and Prevention 

26 to— 


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1 ‘‘(A) develop unique and innovative post2 treatment programs, services, and demonstra3 tions designed to support and advance cancer 

4 survivorship through— 

5 ‘‘(i) promotion of physical activity and 

6 healthy lifestyles; 

7 ‘‘(ii) educational outreach programs 

8 for health care providers; 

9 ‘‘(iii) support for innovative programs 

10 to improve the quality of life among cancer 

11 survivors; 

12 ‘‘(iv) home and community-based 

13 interventions; 

14 ‘‘(v) peer support and mentor pro15 grams; 

16 ‘‘(vi) public awareness and outreach 

17 campaigns; and 

18 ‘‘(vii) information dissemination to in19 form health care providers and cancer sur20 vivors of their health care options and 

21 available survivorship programs; and 

22 ‘‘(B) develop unique cancer survivorship 

23 demonstration programs designed to address 

24 the needs of underserved populations, including 


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1 minorities, children, and individuals residing in 

2 rural areas. 

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

4 shall ensure that activities carried out under this section 

5 are coordinated as appropriate with other agencies of the 

6 Public Health Service. 

7 ‘‘(d) REPORT TO CONGRESS.—Not later than Octo8 ber 1, 2008, the Secretary shall submit to Congress a re9 port describing the results of the study conducted under 

10 subsection (a), and as applicable, the strategies developed 

11 under such subsection. 

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

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

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

15 2008 through 2011. 

16 ‘‘SEC. 417G–6. MONITORING AND EVALUATING CANCER 

17 CARE IN CANCER SURVIVORSHIP. 

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

19 the Director of the Institute and the Director of the Na20 tional Cancer Institute, shall make grants to eligible enti21 ties for the purpose of enabling such entities to develop, 

22 monitor, and evaluate information concerning quality can23 cer care in cancer survivorship. 


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

2 for a grant under this section for a fiscal year if such enti3 ty— 

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

5 funds from a grant made under section 399B for 

6 such fiscal year; or 

7 ‘‘(2) has the capacities for ideal systems and 

8 the ability to link data on phases of cancer care that 

9 go beyond medical record data (on initial course of 

10 cancer diagnosis and treatment) to longer term care 

11 and to also allow for ascertaining patient’s needs 

12 and perspectives. 

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

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

15 expend a grant under such subsection to enter into con16 tracts with academic institutions, cancer centers, and 

17 other entities, when determined appropriate by the Sec18 retary. 

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

20 subsection (a), an eligible entity shall submit to the Sec21 retary an application at such time, in such manner, and 

22 containing such agreements, assurances, and information 

23 as the Secretary determines to be necessary to carry out 

24 this section. 


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

2 GRANT FUNDS.—The Secretary shall determine the ap3 propriate uses of grant funds under subsection (a) to 

4 achieve the purpose described in such subsection. 

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

6 purpose of carrying out this section, there are authorized 

7 to be appropriated such sums as may be necessary for 

8 each of fiscal years 2007 through 2011. 

9 ‘‘SEC. 417E–7. CANCER CARE GUIDELINES. 

10 ‘‘The National Cancer Institute shall regularly con11 vene cancer experts, cancer care providers, practicing 

12 oncologists, patients, representatives of disparity popu13 lations, and other relevant experts and organizations, in14 cluding representatives of the Agency for Healthcare Re15 search and Quality, the Health Resources Administration, 

16 and the Centers for Disease Control and Prevention, to 

17 coordinate the development and regularly update— 

18 ‘‘(1) consensus protocols and guidelines for op19 timal cancer treatments and prevention, including 

20 palliation, symptom management, and end-of-life 

21 care; and 

22 ‘‘(2) guidelines for providing patients with mul23 tidisciplinary consultation before treatment is initi24 ated to provide overall coordination and management 


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1 of cancer care among all providers of the patient’s 

2 treatment and services. 

3 ‘‘SEC. 417E–8. OTHER ACTIVITIES TO IMPROVE OUTCOMES 

4 OF CANCER CARE. 

5 ‘‘(a) IN GENERAL.— 

6 ‘‘(1) RESEARCH.—The Director of the Insti7 tute, in consultation with the entities described in 

8 section 417E–8, shall conduct and support research 

9 and other activities to build an evidence base regard10 ing effective clinical and organizational intervention 

11 strategies to improve the quality and outcomes of 

12 cancer care, and access to such care, at all stages 

13 of the health care continuum. 

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

15 the Director of the Institute shall take into account 

16 the breadth of the continuum of cancer care, from 

17 prevention and early detection, through diagnosis 

18 and treatment, to rehabilitation, long term survivor19 ship and remission, through psychosocial, palliative, 

20 and end-of-life care. 

21 ‘‘(b) SPECIFIC REQUIREMENTS.—The Director of the 

22 Institute shall— 

23 ‘‘(1) ensure the targeted dissemination of the 

24 most current scientific evidence in appropriate for25 mats for use by organizations representing cancer 


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1 patients and their families, professional societies and 

2 organizations representing cancer care providers, 

3 and organizations through which health care and 

4 support services are delivered; and 

5 ‘‘(2) develop effective strategies to facilitate pa6 tient communication with health care providers re7 garding such protocols and guidelines and to ensure 

8 overall coordination and management of cancer care 

9 by providers. 

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

11 is authorized to be appropriated to carry out this section 

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

13 2007 through 2011.’’. 

14 SEC. 104. NATIONAL INSTITUTE FOR ENVIRONMENTAL 

15 HEALTH SCIENCES. 

16 (a) IN GENERAL.—Not later than 6 months after the 

17 date of enactment of this Act, the Director of the National 

18 Institute for Environmental Health Sciences shall, in co19 ordination with the National Cancer Institute, prepare 

20 and submit to the Secretary of Health and Human Serv21 ices a strategic plan that identifies the unmet needs, 

22 progress goals and benchmarks, and the level of funding 

23 necessary for research on environmental risk factors for 

24 cancer and gene-environment interactions. 


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1 (b) AUTHORIZATION OF APPROPRIATIONS.—There is 

2 authorized to be appropriated to carry out this section 

3 such sums as may be necessary. 

4 SEC. 105. NATIONAL CENTER ON MINORITY HEALTH AND 

5 HEALTH DISPARITIES. 

6 Not later than 6 months after the date of enactment 

7 of this Act, the Director of the National Cancer Institute, 

8 in coordination with the National Center on Minority 

9 Health and Health Disparities, shall prepare a strategic 

10 plan that identifies progress goals, benchmarks, and need11 ed resources for research on disparities in cancer treat12 ment, control, and prevention. 

13 SEC. 106. COMPREHENSIVE CANCER CONTROL PLANS. 

14 Section 412 of the Public Health Service Act (42 

15 U.S.C. 285a–1) is amended— 

16 (1) in the first sentence, by inserting ‘‘, for sur17 vivorship,’’ after ‘‘treatment of cancer’’; 

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

19 patients’’ and all that follows and inserting the fol20 lowing: ‘‘cancer patients, families of cancer patients, 

21 and cancer survivors, and’’; and 

22 (3) in paragraph (3), by inserting ‘‘and con23 cerning cancer survivorship programs,’’ after ‘‘con24 trol of cancer’’. 


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1 SEC. 107. LUNG CANCER EARLY DETECTION AND RE2 SEARCH DEMONSTRATION PROJECT. 

3 Title XV of the Public Health Service Act (42 U.S.C. 

4 300k et seq.) is amended by adding at the end the fol5 lowing: 

6 ‘‘SEC. 1511. LUNG CANCER EARLY DETECTION AND RE7 SEARCH DEMONSTRATION PROJECT. 

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

9 the Director of the Centers for Disease Control and Pre10 vention, shall award not less than 10 competitive grants 

11 to public and non-profit private entities to enable such en12 tities to establish demonstration programs pursuant to the 

13 general authority under title III to carry out lung cancer 

14 early detection and research activities using Computer To15 mography (CT) scanning within a high risk population 

16 utilizing the comprehensive protocol that encompasses pre17 diagnosis and post-diagnosis, that was developed under 

18 the best published clinical practices, and that was estab19 lished by the multi-institutional, multi-disciplinary re20 search program initiated in the year 1993. Such dem21 onstration programs shall continue and enhance the re22 search initiated by such protocol into all aspects of early 

23 detection and disease management, the incorporation of 

24 technological advances in imaging and the development of 

25 computer assisted diagnostic tools, and shall include the 

26 provision of appropriate referral and case management for 


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1 the medical treatment of individuals screened pursuant to 

2 this section to ensure appropriate follow-up services for 

3 abnormal tests, diagnostic and therapeutic services, and 

4 treatment for detected cancers subject to the requirements 

5 of this section. 

6 ‘‘(b) REQUIREMENTS.— 

7 ‘‘(1) IN GENERAL.—To be eligible for a grant 

8 under this section, an entity shall agree to adopt the 

9 protocol as defined in subsection (a) for the selection 

10 of participants in the program funded under the 

11 grant, the scanning equipment used in such pro12 gram, the personnel involved in the scanning and di13 agnoses provided under such program, the method of 

14 diagnosing used in the program, the scans utilized 

15 under the program, and the follow-up procedures 

16 used under such program. 

17 ‘‘(2) COLLECTION OF IMAGING DATA.—To be 

18 eligible for a grant under this section, an entity shall 

19 agree to collect, transmit, and preserve imaging data 

20 as required under the protocol as defined in sub21 section (a). Prior to such collection, transmission, 

22 and preservation of imaging data, patient consent 

23 shall be obtained from participating entities as de24 fined by subsection (a). 


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1 ‘‘(3) RELATIONSHIP TO ITEMS AND SERVICES

2 UNDER OTHER PROGRAMS.—To be eligible for a 

3 grant under this section, an entity shall agree that 

4 grant funds will not be expended to make payments 

5 for any item or service to the extent that payment 

6 has been made, or can reasonably be expected to be 

7 made, with respect to such item or service— 

8 ‘‘(A) under any State compensation pro9 gram, under an insurance policy, or under any 

10 Federal or State health benefits program; or 

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

12 service on a prepaid basis. 

13 ‘‘(4) RECORDS AND AUDITS.—To be eligible for 

14 a grant under this section, an entity shall— 

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

16 accounting procedures as may be necessary to 

17 ensure proper disbursal of, and accounting for, 

18 amounts received under this section; and 

19 ‘‘(B) provide agreed upon annual reports 

20 to the Secretary or the Comptroller General of 

21 the United States for the purposes of auditing 

22 the expenditures of the entity. 

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

24 under subsection (a) an entity shall agree to submit 


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1 to the Secretary such reports as the Secretary deems 

2 appropriate. 

3 ‘‘(c) DEFINITION.—In this section, the term ‘high 

4 risk population’ means those individuals over the age of 

5 50 with a smoking history of 20 pack years or a family 

6 history of lung cancer, or those individuals whose occupa7 tion or military service exposed them to asbestos, Agent 

8 Orange and other herbicides, beryllium, radon, nuclear 

9 fuels or waste, or other lung cancer carcinogens. 

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

11 is authorized to be appropriated to carry out this section 

12 such sums as may be necessary for each of the fiscal years 

13 2007 through 2011.’’. 

14 SEC. 108. COLORECTAL CANCER SCREENING. 

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

16 300k et seq.), as amended by section 106, is further 

17 amended by adding at the end the following: 

18 ‘‘SEC. 1512. COLORECTAL CANCER SCREENING DEM19 ONSTRATION PROJECT. 

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

21 the Director of the Centers for Disease Control and Pre22 vention, shall award competitive grants to public and non23 profit private entities to enable such entities to establish 

24 demonstration programs pursuant to the general authority 


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1 of title III to carry out colorectal screening activities in2 cluding— 

3 ‘‘(1) screening asymptomatic individuals for 

4 colorectal cancer as a preventive health measure ac5 cording to scientific evidence-based screening guide6 lines; 

7 ‘‘(2) providing the full continuum of cancer care 

8 for individuals screened pursuant to this section and 

9 to ensure the appropriate follow-up services for ab10 normal tests, diagnostic and therapeutic services, 

11 and treatment for detected cancers, subject to the 

12 requirements of subsection (c)(2); 

13 ‘‘(3) activities to improve the education, train14 ing, and skills of health professionals (including al15 lied health professionals) in the detection and con16 trol of colorectal cancer; 

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

18 this section through appropriate surveillance or pro19 gram monitoring activities; 

20 ‘‘(5) the development and dissemination of find21 ings derived through such evaluations through public 

22 and professional education; and 

23 ‘‘(6) activities to promote participation in the 

24 colorectal cancer screening under this section. 


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1 ‘‘(b) USE OF CERTAIN STANDARDS UNDER MEDI2 CARE PROGRAM.—A grant may be awarded under sub3 section (a) only if the applicant involved agrees that— 

4 ‘‘(1) screenings under subsection (a)(1) will be 

5 carried out as preventive health measures in accord6 ance with evidence-based screening procedures as 

7 specified in section 1861(pp)(1) of the Social Secu8 rity Act; 

9 ‘‘(2) an individual will be considered high risk 

10 for purposes of subsection (a)(1)(B)(ii) only if the 

11 individual is high risk within the meaning of section 

12 1861(pp)(2) of such Act; and 

13 ‘‘(3) the payment made from the grant for a 

14 screening procedure under subsection (a)(1) will not 

15 exceed the amount that would be paid under part B 

16 of title XVIII of such Act if payment were made 

17 under such part for furnishing the procedure to an 

18 individual enrolled under such part. 

19 ‘‘(c) REQUIREMENTS.— 

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

21 under subsection (a), an entity shall agree to give 

22 priority with respect to activities and services under 

23 the grant to a low-income— 

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

25 age; or 


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

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

3 Social Security Act) and is under 50 years of 

4 age. 

5 ‘‘(2) RELATIONSHIP TO ITEMS AND SERVICES

6 UNDER OTHER PROGRAMS.—To be eligible for a 

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

8 that grant funds will not be expended to make pay9 ments for any item or service to the extent that pay10 ment has been made, or can reasonably be expected 

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

12 ‘‘(A) under any State compensation pro13 gram, under an insurance policy, or under any 

14 Federal or State health benefits program; or 

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

16 service on a prepaid basis. 

17 ‘‘(3) RECORDS AND AUDITS.—To be eligible for 

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

19 that the entity will— 

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

21 accounting procedures as may be necessary to 

22 ensure proper disbursal of, and accounting for, 

23 amounts received under this section; and 

24 ‘‘(B) provide agreed upon annual reports 

25 to the Secretary or the Comptroller General of 


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1 the United States for the purposes of auditing 

2 the expenditures by the entity. 

3 ‘‘(4) REPORTS.—To be eligible for a grant 

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

5 to the Secretary such reports as the Secretary deter6 mines appropriate. 

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

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

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

10 2007 through 2011.’’. 

11 SEC. 109. NATIONAL PROGRAM OF CANCER REGISTRIES. 

12 Part M of title III of the Public Health Service Act 

13 (42 U.S.C. 280e et seq.) is amended by inserting after 

14 section 399B the following: 

15 ‘‘SEC. 399B–1. ENHANCING CANCER REGISTRIES AND PRE16 PARING FOR THE FUTURE. 

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

18 of the National Cancer Act of 2007 the Secretary shall 

19 develop a plan and submit a report to Congress that out20 lines strategies by which the State cancer registries funded 

21 with grants under section 399B and the Surveillance, Epi22 demiology, and End Results program of the National Can23 cer Institute (in this section referred to as the ‘SEER pro24 gram’) can share information to ensure more comprehenVerDate Aug 31 2005 01:50 Apr 11, 2007 Jkt 059200 PO 00000 Frm 00035 Fmt 6652 Sfmt 6201 E:\BILLS\S1056.IS S1056

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1 sive cancer data. The report shall include ways in which 

2 the Secretary will— 

3 ‘‘(1) standardize data between State cancer reg4 istries and the SEER program; 

5 ‘‘(2) increase the portability and usability of 

6 data files from each registry for researchers and 

7 public health planners; 

8 ‘‘(3) ensure data collection from the greatest 

9 number of health care facilities possible; 

10 ‘‘(4) maximize the use of State registry data 

11 and data from the SEER program in State and re12 gional public health planning processes; and 

13 ‘‘(5) promote the use of data to— 

14 ‘‘(A) improve the health status of cancer 

15 survivors; and 

16 ‘‘(B) research quality of cancer care and 

17 access to that care. 

18 ‘‘SEC. 399B–2. NATIONAL CHILDHOOD CANCER REGISTRY. 

19 ‘‘(a) IN GENERAL.—The Director of the National In20 stitute of Health (in this section referred to as the ‘Direc21 tor’) shall, through the awarding of a grant to, or contract 

22 or cooperative agreement with, support the existing Na23 tional Cancer Institute-designated multi-center national 

24 infrastructure for collaborative pediatric cancer research 

25 to support a national population-based childhood cancer 


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1 database, the Childhood Cancer Research Network, in 

2 order to— 

3 ‘‘(1) formalize the consent process by which pe4 diatric cancer patients enroll on to a clinical trial or 

5 receive treatment within the multi-center infrastruc6 ture; 

7 ‘‘(2) conduct non-therapeutic studies, monitor 

8 and evaluate the incidence, survival rate, and long9 term health outcomes of childhood cancer patients, 

10 develop information concerning best practices in pe11 diatric cancer care; and 

12 ‘‘(3) evaluate the quality of pediatric cancer 

13 care, and monitor long-term pediatric cancer survi14 vorship. 

15 ‘‘(b) COORDINATION.—The Director shall carry out 

16 this section jointly through the Director of the Centers 

17 for Disease Control and Prevention and the Director of 

18 the National Cancer Institute. 

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

20 is authorized to be appropriated, such sums as may be 

21 necessary to carry out this section.’’. 

22 SEC. 110. OTHER TRANSACTIONS AUTHORITY. 

23 Section 402(i) of the Public Health Service Act (42 

24 U.S.C. 282(i)) is amended by adding at the end the fol25 lowing: 


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1 ‘‘(4) Notwithstanding any other provision of law, the 

2 Director of the National Cancer Institute may use 

3 amounts appropriated under section 417B(a) to enter into 

4 transactions (other than contracts, cooperative agree5 ments, or grants) to carry out research in support of the 

6 development of advanced technologies leading to the expe7 dited delivery of clinical products to benefit the cancer pa8 tient.’’. 

9 TITLE II—EXPANDING ACCESS 

10 TO CANCER DRUGS AND 

11 TREATMENT 

12 SEC. 201. DRUGS TO PREVENT CANCER. 

13 (a) IN GENERAL.—Chapter V of the Federal Food, 

14 Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amend15 ed by adding at the end the following: 

16 ‘‘Subtitle G—Chemoprevention 

17 Drugs 

18 ‘‘SEC. 581. RECOMMENDATIONS FOR INVESTIGATIONS OF 

19 CHEMOPREVENTION DRUGS. 

20 ‘‘(a) IN GENERAL.—The sponsor of a 

21 chemoprevention drug in the States may request the Sec22 retary to provide written recommendations for the nonclin23 ical and clinical investigations which must be conducted 

24 with the drug before— 


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1 ‘‘(1) it may be approved under section 505 for 

2 the high-risk condition that the drug is designed to 

3 treat; or 

4 ‘‘(2) if the drug is a biological product, it may 

5 be licensed under section 351 of the Public Health 

6 Service Act for such condition. 

7 If the Secretary has reason to believe that a drug for 

8 which a request is made under this section is a 

9 chemoprevention drug, the Secretary shall provide the per10 son making the request written recommendations for the 

11 nonclinical and clinical investigations which the Secretary 

12 believes, on the basis of information available to the Sec13 retary at the time of the request under this section, would 

14 be necessary for approval under section 505 or licensing 

15 under section 351 of the Public Health Service Act of such 

16 chemoprevention drug for the high-risk condition that 

17 such drug is designed to treat. 

18 ‘‘(b) REGULATIONS.—The Secretary shall by regula19 tion promulgate procedures for the implementation of sub20 section (a). 

21 ‘‘SEC. 582. DESIGNATION OF CHEMOPREVENTION DRUGS. 

22 ‘‘(a) DESIGNATION.— 

23 ‘‘(1) IN GENERAL.—The manufacturer or the 

24 sponsor of a drug may request the Secretary to des25 ignate the drug as a chemoprevention drug. A reVerDate Aug 31 2005 01:50 Apr 11, 2007 Jkt 059200 PO 00000 Frm 00039 Fmt 6652 Sfmt 6201 E:\BILLS\S1056.IS S1056

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1 quest for designation of a drug shall be made before 

2 the submission of an application under section 

3 505(b) for the drug or the submission of an applica4 tion for licensing of the drug under section 351 of 

5 the Public Health Service Act. If the Secretary finds 

6 that a drug for which a request is submitted under 

7 this subsection is a chemoprevention drug that is 

8 being or will be investigated for a high-risk condition 

9 and— 

10 ‘‘(A) if an application for such drug is ap11 proved under section 505; or 

12 ‘‘(B) if a license for such drug is issued 

13 under section 351 of the Public Health Service 

14 Act, 

15 the approval or license would be for use for such 

16 high-risk condition, the Secretary shall designate the 

17 drug as a chemoprevention drug for such high-risk 

18 condition. A request for a designation of a drug 

19 under this subsection shall contain the consent of 

20 the applicant to notice being given by the Secretary 

21 under subsection (b) respecting the designation of 

22 the drug. 

23 ‘‘(2) DEFINITIONS.—In this subtitle: 


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1 ‘‘(A) CHEMOPREVENTION DRUG.—The 

2 term ‘chemoprevention drug’ means a drug de3 signed to treat a high-risk condition. 

4 ‘‘(B) HIGH-RISK CONDITION.—The term 

5 ‘high-risk condition’ means a medical condition 

6 that— 

7 ‘‘(i) has been diagnosed in individuals 

8 who have not been diagnosed with cancer 

9 or who do not currently have progressive, 

10 life-threatening cancer; and 

11 ‘‘(ii) unless treated, could develop into 

12 progressive and life-threatening cancer 

13 ‘‘(C) DETERMINATION.—Determinations 

14 under subparagraphs (A) and (B) with respect 

15 to any drug shall be made on the basis of the 

16 facts and circumstances as of the date the re17 quest for designation of the drug under this 

18 subsection is made. 

19 ‘‘(b) CONDITIONS OF DESIGNATION.—A designation 

20 of a drug under subsection (a) shall be subject to the con21 dition that— 

22 ‘‘(1) if an application was approved for the 

23 drug under section 505(b) or a license was issued 

24 for the drug under section 351 of the Public Health 

25 Service Act, the manufacturer of the drug will notify 


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1 the Secretary of any discontinuance of the produc2 tion of the drug at least 1 year before discontinu3 ance; and 

4 ‘‘(2) if an application has not been approved for 

5 the drug under section 505(b) or a license has not 

6 been issued for the drug under section 351 of the 

7 Public Health Service Act and if preclinical inves8 tigations or investigations under section 505(i) are 

9 being conducted with the drug, the manufacturer or 

10 sponsor of the drug will notify the Secretary of any 

11 decision to discontinue active pursuit of approval of 

12 an application under section 505(b) or approval of 

13 a license under section 351 of the Public Health 

14 Service Act. 

15 ‘‘(c) NOTICE.—Notice respecting the designation of 

16 a drug under subsection (a) shall be made available to the 

17 public. 

18 ‘‘(d) REGULATIONS.—The Secretary shall by regula19 tion promulgate procedures for the implementation of sub20 section (a). 

21 ‘‘SEC. 583. PROTECTION FOR CHEMOPREVENTION DRUGS. 

22 ‘‘(a) IN GENERAL.—Except as provided in subsection 

23 (b), if the Secretary— 

24 ‘‘(1) approves an application filed pursuant to 

25 section 505(b); or 


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1 ‘‘(2) issues a license under section 351 of the 

2 Public Health Service Act, 

3 for a drug designated as a chemoprevention drug under 

4 section 582, the Secretary may not approve another appli5 cation under section 505(b) or issue another license under 

6 section 351 of the Public Health Service Act for such drug 

7 for the high-risk condition that such drug is designated 

8 for a person who is not the holder of such approved appli9 cation or of such license until the expiration 7 years from 

10 the date of the approval of the approved application or 

11 the issuance of the license. Section 505(c)(2) does not 

12 apply to the refusal to approve an application under the 

13 preceding sentence. 

14 ‘‘(b) OTHER APPLICATION APPROVAL.—If an appli15 cation filed pursuant to section 505(b) is approved for a 

16 drug designated as a chemoprevention drug under section 

17 582 or if a license is issued under section 351 of the Public 

18 Health Service Act for such a drug, the Secretary may, 

19 during the 7-year period beginning on the date of the ap20 plication approval or of the issuance of the license, approve 

21 another application under section 505(b) or issue a license 

22 under section 351 of the Public Health Service Act, for 

23 such drug for the high-risk condition that such drug is 

24 designated for a person who is not the holder of such ap25 proved application or of such license if— 


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1 ‘‘(1) the Secretary finds, after providing the 

2 holder notice and opportunity for the submission of 

3 views, that in such period the holder of the approved 

4 application or of the license cannot assure the avail5 ability of sufficient quantities of the drug to meet 

6 the needs of persons with such high-risk condition 

7 for which the drug was designated; or 

8 ‘‘(2) such holder provides the Secretary in writ9 ing the consent of such holder for the approval of 

10 other applications or the issuance of other licenses 

11 before the expiration of such 7-year period. 

12 ‘‘(c) MARKET EXCLUSIVITY FOR CHEMOPREVENTION

13 DRUGS DESIGNATED FOR A HIGH-RISK CONDITION.—If 

14 the Secretary designates a drug as a chemoprevention 

15 drug for a high-risk condition under section 582— 

16 ‘‘(1)(A) the period referred to in subsection 

17 (c)(3)(E)(ii) of section 505, and in subsection 

18 (j)(5)(F)(ii) of such section, is deemed to be twelve 

19 years rather than five years, and the references in 

20 subsections (c)(3)(E)(ii) and (j)(5)(F)(ii) of such 

21 section to four years, to forty-eight months, and to 

22 seven and one-half years are deemed to be eleven 

23 years, one hundred thirty-two months, and fourteen 

24 and one-half years, respectively; or 


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1 ‘‘(B) the period referred to in clauses (iii) and 

2 (iv) of subsection (c)(3)(E) of such section, and in 

3 clauses (iii) and (iv) of subsection (j)(5)(F) of such 

4 section, is deemed to be ten years rather than three 

5 years; 

6 ‘‘(2)(A) if the drug is the subject of— 

7 ‘‘(i) a listed patent for which a certification 

8 has been submitted under subsection 

9 (b)(2)(A)(ii) or (j)(2)(A)(vii)(II) of section 505; 

10 or 

11 ‘‘(ii) a listed patent for which a certifi12 cation has been submitted under subsections 

13 (b)(2)(A)(iii) or (j)(2)(A)(vii)(III) of section 

14 505, 

15 the period during which an application may not 

16 be approved under section 505(c)(3) or section 

17 505(j)(5)(B) shall be extended by a period of 

18 seven years after the date the patent expires 

19 (including any patent extensions); or 

20 ‘‘(B) if the drug is the subject of a listed patent 

21 for which a certification has been submitted under 

22 subsection (b)(2)(A)(iv) or (j)(2)(A)(vii)(IV) of sec23 tion 505, and in the patent infringement litigation 

24 resulting from the certification the court determines 

25 that the patent is valid and would be infringed, the 


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1 period during which an application may not be ap2 proved under section 505(c)(3) or section 

3 505(j)(5)(B) shall be extended by a period of seven 

4 years after the date the patent expires (including 

5 any patent extensions); and 

6 ‘‘(3) with respect to a drug that is so des7 ignated that is also subject to market exclusivity ex8 tension under section 505A, the extension of the pe9 riods described under paragraphs (1) and (2) of this 

10 subsection shall be increased by six months in ac11 cordance with such section 505A. 

12 ‘‘SEC. 584. OPEN PROTOCOLS FOR INVESTIGATIONS OF 

13 CHEMOPREVENTION DRUGS. 

14 ‘‘If a drug is designated under section 582 as a 

15 chemoprevention drug and if notice of a claimed exemption 

16 under section 505(i) or regulations issued thereunder is 

17 filed for such drug, the Secretary shall encourage the 

18 sponsor of such drug to design protocols for clinical inves19 tigations of the drug which may be conducted under the 

20 exemption to permit the addition to the investigations of 

21 persons with the high-risk condition for which such drug 

22 was designated.’’. 

23 (b) GRANTS AND CONTRACTS FOR DEVELOPMENT OF

24 CHEMOPREVENTION DRUGS.— 


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1 (1) IN GENERAL.—The Secretary may make 

2 grants to and enter into contracts with public and 

3 private entities and individuals to assist in— 

4 (A) defraying the costs of qualified clinical 

5 testing expenses incurred in connection with the 

6 development of chemoprevention drugs; 

7 (B) defraying the costs of developing 

8 chemoprevention devices; and 

9 (C) defraying the costs of developing 

10 chemoprevention foods. 

11 (2) DEFINITIONS.—For purposes of this sub12 section: 

13 (A) CHEMOPREVENTION DEVICE.—The 

14 term ‘‘chemoprevention device’’ means a device 

15 to be approved to treat a high-risk condition. 

16 (B) CHEMOPREVENTION DRUG.—The term 

17 ‘‘chemoprevention drug’’ means a drug designed 

18 to treat a high-risk condition. 

19 (C) CHEMOPREVENTION FOOD.—The term 

20 ‘‘chemoprevention food’’ means a food which is 

21 formulated to be consumed or administered 

22 enterally under the supervision of a physician 

23 and which is intended for the specific dietary 

24 management of a type of high-risk condition for 

25 which distinctive nutritional requirements, 


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1 based on recognized scientific principles, are es2 tablished by medical evaluation. 

3 (D) HIGH-RISK CONDITION.— 

4 (i) IN GENERAL.—The term ‘‘high5 risk condition’’ means, with respect to a 

6 chemoprevention drug, chemoprevention 

7 device, or chemoprevention food, a medical 

8 condition that— 

9 (I) has been diagnosed in individ10 uals who have not been diagnosed 

11 with cancer or who do not currently 

12 have progressive, life-threatening can13 cer; and 

14 (II) unless treated, could develop 

15 into progressive and life-threatening 

16 cancer. 

17 (ii) DETERMINATION.—Determina18 tions under this subparagraph with respect 

19 to any drug, device, or food shall be made 

20 on the basis of the facts and circumstances 

21 as of the date the request for designation 

22 of the drug or food under section 582 of 

23 the Federal Food, Drug, and Cosmetic Act 

24 is made. 


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1 (E) QUALIFIED TESTING.—The term 

2 ‘‘qualified testing’’ means— 

3 (i) human clinical testing— 

4 (I) which is carried out under an 

5 exemption for a chemoprevention drug 

6 under section 505(i) of the Federal 

7 Food, Drug, and Cosmetic Act (21 

8 U.S.C. 355(i)); and 

9 (II) which occurs after the date 

10 such drug is designated under section 

11 582 of such Act (as added by sub12 section (a)) and before the date on 

13 which an application with respect to 

14 such drug is submitted under section 

15 505(b) of such Act (21 U.S.C. 

16 355(b)) or under section 351 of the 

17 Public Health Service Act (42 U.S.C. 

18 292); and 

19 (ii) preclinical testing involving a drug 

20 is designated under such section 582 and 

21 before the date on which an application 

22 with respect to such drug is submitted 

23 under such section 505(b) or under such 

24 section 351. 


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1 (3) AUTHORIZATION OF APPROPRIATIONS.— 

2 There is authorized to be appropriated to carry out 

3 this section such sums as may be necessary for each 

4 of fiscal years 2008 through 2010. 

5 (c) STUDIES.— 

6 (1) MEDICAL DEVICES OR MEDICAL FOOD FOR

7 HIGH RISK CONDITIONS.—The Secretary of Health 

8 and Human Services shall conduct a study to deter9 mine whether the application of subchapter G of 

10 chapter V of the Federal Food, Drug, and Cosmetic 

11 Act (as added by subsection (a)) to medical devices 

12 or medical foods for the high-risk condition for 

13 which such devices or foods are designated, or to 

14 both, is needed to encourage the development of 

15 such devices and foods. The Secretary shall report 

16 the results of the study to the Committee on Energy 

17 and Commerce of the House of Representatives and 

18 the Committee on Health, Education, Labor and 

19 Pensions of the Senate not later than 1 year after 

20 the date of the enactment of this Act. 

21 (2) CHEMOPREVENTION PRODUCTS.—The Di22 rector of the Institute of Medicine shall conduct a 

23 study to measure the quality and quantity of 

24 chemoprevention products resulting from the appli25 cation of subpart G of chapter V of the Federal 


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1 Food, Drug, and Cosmetic Act to drugs, medical de2 vices, and medical foods for which such drugs, de3 vices, and foods are designated, or to all. 

4 (d) CHEMOPREVENTION PRODUCTS BOARD.—Part A 

5 of title II of the Public Health Service Act (42 U.S.C. 

6 202 et seq.) is amended by adding at the end the fol7 lowing: 

8 ‘‘SEC. 229. CHEMOPREVENTION PRODUCTS BOARD. 

9 ‘‘(a) IN GENERAL.—There is established in the De10 partment of Health and Human Services a board for the 

11 development of chemoprevention drugs (including bio12 logics) and devices (including diagnostic products), to be 

13 known as the Chemoprevention Products Board (referred 

14 to in this section as the ‘Board’). The Board shall be com15 prised of the Assistant Secretary for Health of the Depart16 ment of Health and Human Services and representatives, 

17 selected by the Secretary, of the Food and Drug Adminis18 tration, the National Institutes Health, the Centers for 

19 Disease Control and Prevention, and any other Federal 

20 department or agency which the Secretary determines has 

21 activities relating to chemoprevention drugs and devices. 

22 The Assistant Secretary for Health shall chair the Board. 

23 ‘‘(b) DEFINITIONS.—In this section: 

24 ‘‘(1) CHEMOPREVENTION DEVICE.—The term 

25 ‘chemoprevention device’ has the meaning given such 


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1 term in section 582 of the Federal Food, Drug, and 

2 Cosmetic Act. 

3 ‘‘(2) CHEMOPREVENTION DRUG.—The term 

4 ‘chemoprevention drug’ has the meaning given such 

5 term in section 582 of the Federal Food, Drug, and 

6 Cosmetic Act. 

7 ‘‘(3) HIGH-RISK CONDITION.—The term ‘high8 risk condition’ has the meaning given such term in 

9 section 582 of the Federal Food, Drug, and Cos10 metic Act. 

11 ‘‘(c) FUNCTION.—The function of the Board shall be 

12 to promote the development of chemoprevention drugs and 

13 devices and the coordination among Federal, other public, 

14 and private agencies in carrying out their respective func15 tions relating to the development of such articles for such 

16 drugs to treat high-risk conditions. 

17 ‘‘(d) DUTIES.—In the case of chemoprevention drugs, 

18 the Board shall— 

19 ‘‘(1) evaluate— 

20 ‘‘(A) the effect of subchapter G of chapter 

21 V of the Federal Food, Drug, and Cosmetic Act 

22 on the development of such drugs; and 

23 ‘‘(B) the implementation of such sub24 chapter; and 


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1 ‘‘(2) evaluate the activities of the National In2 stitutes of Health and the Alcohol, Drug Abuse, and 

3 Mental Health Administration for the development 

4 of such drugs for high-risk conditions; 

5 ‘‘(3) assure appropriate coordination among the 

6 Food and Drug Administration, the National Insti7 tutes of Health, the Alcohol, Drug Abuse, and Men8 tal Health Administration, and the Centers for Dis9 ease Control and Prevention in the carrying out of 

10 their respective functions relating to the development 

11 of drugs for high-risk conditions to assure that the 

12 activities of each agency are complementary; 

13 ‘‘(4) assure appropriate coordination among all 

14 interested Federal agencies, manufacturers, and or15 ganizations representing patients, in their activities 

16 relating to such drugs; 

17 ‘‘(5) with the consent of the sponsor of a 

18 chemoprevention drug exempt under section 505(i) 

19 of the Federal Food, Drug, and Cosmetic Act or 

20 regulations issued under such section, inform physi21 cians and the public respecting the availability of 

22 such drug for the high-risk condition for which it is 

23 designated under section 582 of such Act and in24 form physicians and the public respecting the avail25 ability of drugs approved under section 505(c) of 


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1 such Act or licensed under section 351 of this Act 

2 for chemoprevention; 

3 ‘‘(6) seek business entities and others to under4 take the sponsorship of chemoprevention drugs, seek 

5 investigators to facilitate the development of such 

6 drugs, and seek business entities to participate in 

7 the distribution of such drugs; 

8 ‘‘(7) reorganize and incentivize collaborative ef9 forts between public and private entities and efforts 

10 by individuals seeking the development of 

11 chemoprevention drugs in developing such drugs; 

12 and 

13 ‘‘(8) promote healthy competition to support 

14 the steady movement of chemoprevention products 

15 through the research and development process. 

16 ‘‘(e) CONSULTATION.—The Board shall consult with 

17 interested persons respecting the activities of the Board 

18 under this section and as part of such consultation shall 

19 provide the opportunity for the submission of oral views. 

20 ‘‘(f) ANNUAL REPORT.— 

21 ‘‘(1) IN GENERAL.—Not later than June 1 of 

22 each year, the Board shall submit to the Committee 

23 on Health, Education, Labor and Pensions of the 

24 Senate and the Committee on Energy and Com25 merce of the House of Representatives an annual reVerDate Aug 31 2005 01:50 Apr 11, 2007 Jkt 059200 PO 00000 Frm 00054 Fmt 6652 Sfmt 6201 E:\BILLS\S1056.IS S1056

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1 port, that, with respect to the preceding calendar 

2 year— 

3 ‘‘(A) identifies the drugs which have been 

4 designated under section 582 of the Federal 

5 Food, Drug, and Cosmetic Act as 

6 chemoprevention drugs; 

7 ‘‘(B) describes the activities of the Board; 

8 and 

9 ‘‘(C) contains the results of the evaluations 

10 carried out by the Board. 

11 ‘‘(2) ADDITIONAL INFORMATION FOR INCLU12 SION IN ANNUAL REPORT.— 

13 ‘‘(A) RESEARCH ACTIVITIES.—The Direc14 tor of the National Institutes of Health and the 

15 Administrator of the Alcohol, Drug Abuse, and 

16 Mental Health Administration shall submit to 

17 the Board for inclusion in the annual report 

18 under paragraph (1) a report on the 

19 chemoprevention research activities of the Insti20 tutes of the National Institutes of Health and 

21 the Alcohol, Drug Abuse, and Mental Health 

22 Administration. 

23 ‘‘(B) EFFECT OF PROVISIONS.—The Sec24 retary shall submit to the Board for inclusion 

25 in the annual report under paragraph (1) a reVerDate Aug 31 2005 01:50 Apr 11, 2007 Jkt 059200 PO 00000 Frm 00055 Fmt 6652 Sfmt 6201 E:\BILLS\S1056.IS S1056

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1 port on the program of assistance under section 

2 ll(c) of the National Cancer Act of 2007 for 

3 the development of chemoprevention drugs.’’. 

4 (e) SENSE OF THE SENATE ON CHEMOPREVENTION

5 DRUGS.—It is the sense of the Senate that— 

6 (1) adequate chemoprevention drugs have not 

7 been developed; 

8 (2) there is reason to believe that promising 

9 chemoprevention drugs will not be developed unless 

10 changes are made in the applicable Federal laws to 

11 reduce the costs of developing such drugs and to 

12 provide incentives to develop such drugs; and 

13 (3) it is in the public interest to provide such 

14 changes and incentives for the development of 

15 chemoprevention drugs. 

16 SEC. 202. COMPASSIONATE ACCESS TO INVESTIGATIONAL 

17 DRUGS AND DEVICES. 

18 (a) IN GENERAL.—Section 561 of the Federal Food, 

19 Drug, and Cosmetic Act (21 U.S.C. 360bbb) is amended 

20 by adding at the end the following: 

21 ‘‘(f) ONCOLOGIC COMPASSIONATE ACCESS PRO22 GRAM.—Acting under the existing expanded access pro23 gram, the Secretary shall establish a new program to ex24 pand access to investigational treatments for individuals 

25 diagnosed with cancer who have exhausted all treatment 


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1 options approved by Secretary for the condition or disease 

2 for which the patient is a reasonable candidate, and have 

3 unsuccessfully sought treatment, or obtained treatment 

4 that was not effective, with an investigational drug, bio5 logical product, or device for which such individual is a 

6 reasonable candidate. In carrying out this compassionate 

7 access program, the Secretary shall publish and broadly 

8 disseminate written guidance to health care providers and 

9 organizations representative of patients diagnosed with 

10 cancer that— 

11 ‘‘(1) describes such compassionate access pro12 grams for investigational drugs, biological products, 

13 and devices intended to treat cancer; 

14 ‘‘(2) facilitates the provision of investigational 

15 drugs and devices to seriously ill cancer patients 

16 without unreasonable delay by recognizing that the 

17 use of available investigational products for treat18 ment is the responsibility of the physician and the 

19 patient; and 

20 ‘‘(3) facilitates the contribution of safety and 

21 efficacy data of investigational treatments from par22 ticipants in such compassionate access program. 

23 ‘‘(g) IMPLEMENTATION OF COMPASSIONATE ACCESS

24 PROGRAMS.— 


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1 ‘‘(1) TRAINING OF PERSONNEL.—Not later 

2 than 90 days after the date of enactment of this 

3 subsection, the Secretary shall implement training 

4 programs at the Food and Drug Administration with 

5 respect to existing expanded access program estab6 lished under this section. 

7 ‘‘(2) POLICIES, REGULATIONS, AND GUID8 ANCE.—The Secretary shall establish policies, regu9 lations, and guidance designed to most directly ben10 efit seriously ill cancer patients.’’. 

11 (b) DEVELOPMENT OF SURROGATE ENDPOINTS AND

12 BIOMARKERS.—The Federal Food, Drug, and Cosmetic 

13 Act is amended by inserting after section 561 (21 U.S.C. 

14 360bbb) the following: 

15 ‘‘SEC. 561A. DEVELOPMENT OF SURROGATE ENDPOINTS 

16 AND BIOMARKERS. 

17 ‘‘The Secretary shall— 

18 ‘‘(1) establish a program to encourage the de19 velopment of surrogate endpoints and biomarkers, 

20 which shall include medical images, that are reason21 ably likely to predict— 

22 ‘‘(A) clinical benefit for cancer-related con23 ditions for which there exist significant unmet 

24 medical needs; and 


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1 ‘‘(B) individual risk for cancer-related con2 ditions for which there exist unmet medical 

3 needs; 

4 ‘‘(2) request the Institute of Medicine to under5 take a study to identify validated surrogate 

6 endpoints and biomarkers, which shall include med7 ical images, and recommend research to validate 

8 such surrogate endpoints and biomarkers, that may 

9 support approvals for products intended for the 

10 treatment of cancer; 

11 ‘‘(3) request the Institute of Medicine to under12 take a study to evaluate the practicality of expand13 ing the use of large, community-based simple trials 

14 designed to identify product safety and efficacy in a 

15 larger and more representative patient population of 

16 individuals diagnosed with cancer prior to approving 

17 the product for widespread use; and 

18 ‘‘(4) make available to the public a list of 

19 drugs, biological products, and devices that are being 

20 investigated for cancer and that are in no earlier 

21 than the Phase II stage of clinical trials.’’. 

22 (c) CONFORMING AMENDMENT.—Section 561(c) of 

23 the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

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1 ing ‘‘COMPASSIONATE ACCESS TO INVESTIGATIONAL

2 DRUGS AND DEVICES FOR CANCER PATIENTS.—’’. 

3 SEC. 203. ONCOLOGY DRUGS ADVISORY COMMITTEE. 

4 Subchapter E of chapter V of the Federal Food, 

5 Drug, and Cosmetic Act (21 U.S.C. 360bbb et seq.) is 

6 amended by adding at the end the following: 

7 ‘‘SEC. 566. MEMBERSHIP OF ONCOLOGY DRUGS ADVISORY 

8 COMMITTEE. 

9 ‘‘Membership of the Oncology Drugs Advisory Com10 mittee of the Food and Drug Administration shall consist 

11 of no less than 2 patient representatives who are voting 

12 members of the committee.’’. 

13 SEC. 204. TECHNICAL AMENDMENT. 

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

15 Cosmetic Act (21 U.S.C. 360bb(a)(2)) is amended by in16 serting ‘‘or targets and mechanisms of pathogenesis of dis17 eases’’ after ‘‘disease or condition’’. 

18 TITLE III—PAYMENTS FOR CAN19 CER-RELATED SERVICES AND 

20 PRODUCTS 

21 SEC. 301. COORDINATING CANCER CARE FOR PATIENTS. 

22 (a) CANCER COVERAGE REQUIREMENTS.—Part B of 

23 title XVIII of the Social Security Act (42 U.S.C. 1395j 

24 et seq.) is amended by adding at the end the following: 


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1 ‘‘CANCER COVERAGE REQUIREMENTS

2 ‘‘SEC. 1849. (a) IN GENERAL.—The following provi3 sions shall apply to a participating cancer care coordinator 

4 treating an individual who has been diagnosed with cancer 

5 and who is covered under the insurance program estab6 lished under this part. 

7 ‘‘(b) DEFINITIONS.—In this section: 

8 ‘‘(1) CANCER CARE COORDINATOR.— 

9 ‘‘(A) IN GENERAL.—The term ‘cancer care 

10 coordinator’ means, with respect to items or 

11 services provided under the coverage related to 

12 the treatment of cancer, a lead managing physi13 cian, nurse practitioner with an oncology certifi14 cation (as provided by a nationally accredited 

15 organization), or registered nurse (as provided 

16 by a nationally accredited organization) that is 

17 designated at the time of cancer diagnosis by 

18 the provider, in consultation with the partici19 pant or beneficiary, and other providers in20 volved to provide for the overall coordination 

21 and management of the cancer care of the indi22 vidual among all providers who provide items or 

23 services to the individual, and who otherwise 

24 meet the requirements of this paragraph. 


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1 ‘‘(B) RESPONSIBILITIES.—A designee 

2 under subparagraph (A) shall be responsible for 

3 the overall coordination and management of the 

4 medical, nursing, and other health services pro5 vided to the individual during the period in 

6 which the individual is undergoing treatment 

7 for such cancer. 

8 ‘‘(C) COORDINATION AND MANAGEMENT.— 

9 ‘‘(i) IN GENERAL.—The overall co10 ordination and management under sub11 paragraph (A) shall include the develop12 ment of a plan of care that— 

13 ‘‘(I) details, to the greatest ex14 tent practicable, all aspects of the 

15 care to be provided to the individual, 

16 with respect to the treatment of such 

17 cancer, including any curative treat18 ment and comprehensive symptom 

19 management (such as palliative care) 

20 involved; 

21 ‘‘(II) is furnished in written form 

22 to the individual in person within a 

23 period specified by the Secretary that 

24 is as soon as practicable after the date 


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1 on which the individual is so diag2 nosed; 

3 ‘‘(III) is furnished in a form that 

4 is appropriate for use by disparity 

5 populations, to the extent practicable; 

6 and 

7 ‘‘(IV) is in accordance with 

8 standards determined by the Sec9 retary to be appropriate; 

10 ‘‘(ii) COVERED INDIVIDUAL.—With re11 spect to an individual for whom the plan of 

12 care has been developed under clause (i), 

13 such plan shall be revised as necessary to 

14 account for any substantial change in the 

15 condition of the individual, if such revi16 sion— 

17 ‘‘(I) is in accordance with sub18 clauses (I) and (III) of such clause; 

19 and 

20 ‘‘(II) is furnished in written form 

21 to the individual within a period speci22 fied by the Secretary that is as soon 

23 as practicable after the date of such 

24 revision. 


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1 ‘‘(iii) FOLLOW-UP PLAN.—With re2 spect to an individual who has completed 

3 the primary treatment for cancer, as de4 fined by the Secretary (such as completion 

5 of chemotherapy or radiation treatment), 

6 the development of a follow-up cancer care 

7 plan that— 

8 ‘‘(I) describes the elements of the 

9 primary treatment, including symp10 tom management, furnished to such 

11 individual; 

12 ‘‘(II) provides recommendations 

13 for the subsequent care of the indi14 vidual with respect to the cancer in15 volved; 

16 ‘‘(III) is furnished in written 

17 form to the individual in person with18 in a period specified by the Secretary 

19 that is as soon as practicable after the 

20 completion of such primary treatment; 

21 ‘‘(IV) is furnished in a form that 

22 is appropriate for use by disparity 

23 populations to the extent practicable; 

24 and 


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1 ‘‘(V) is in accordance with stand2 ards determined by the Secretary to 

3 be appropriate. 

4 ‘‘(iv) REVISIONS TO FOLLOW UP

5 PLAN.—With respect to an individual for 

6 whom a follow-up cancer care plan has 

7 been developed under clause (iii), the revi8 sion of such plan as necessary to account 

9 for any substantial change in the condition 

10 of the individual, if such revision— 

11 ‘‘(I) is in accordance with sub12 clauses (I), (II), and (IV) of such 

13 clause; and 

14 ‘‘(II) is furnished in written form 

15 to the individual within a period speci16 fied by the Secretary that is as soon 

17 as practicable after the date of such 

18 revision. 

19 ‘‘(D) STANDARDS.—The Secretary shall 

20 establish standards to carry out this paragraph 

21 in consultation with appropriate organizations 

22 that represent providers of services related to 

23 cancer treatment and organizations rep24 resenting survivors of cancer. Such standards 

25 shall include standards for determining the 


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1 need and frequency for revisions of the plans of 

2 care and follow-up plans based on changes in 

3 the condition of the individual and standards 

4 for the communication of the plan to the pa5 tient. 

6 ‘‘(2) INDIVIDUAL.—The term ‘individual’ means 

7 a person who has been diagnosed with cancer and 

8 who is covered under the insurance program estab9 lished under this part.’’. 

10 (b) ADDITIONAL PAYMENT.—Section 1833(m) of the 

11 Social Security Act (42 U.S.C. 1395 l(m)) is amended by 

12 adding at the end the following new paragraph: 

13 ‘‘(5) In the case of physician or nursing services 

14 furnished to an individual under this section who re15 ceives care for such cancer, there shall be paid to the 

16 cancer care coordinator of that individual during the 

17 period in which that individual is undergoing treat18 ment for such cancer from the Federal Supple19 mentary Medical Insurance Trust Fund, a separate 

20 and additional payment amount for the services 

21 under this part in addition to any amount otherwise 

22 paid under this part.’’. 


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1 SEC. 302. ELIMINATION OF OPTIONAL EXCLUSION FROM 

2 MEDICAID PRESCRIPTION DRUG COVERAGE 

3 FOR TOBACCO CESSATION MEDICATIONS. 

4 (a) IN GENERAL.—Section 1927(d)(2) of the Social 

5 Security Act (42 U.S.C. 1396r–8(d)(2)) is amended— 

6 (1) by striking subparagraph (E); 

7 (2) by redesignating subparagraphs (F) 

8 through (K) as subparagraphs (E) through (J), re9 spectively; and 

10 (3) in subparagraph (F) (as redesignated by 

11 paragraph (2)), by inserting before the period at the 

12 end the following: ‘‘, other than agents approved by 

13 the Food and Drug Administration for purposes of 

14 promoting, and when used to promote, tobacco ces15 sation’’. 

16 (b) EFFECTIVE DATE.—The amendments made by 

17 subsection (a) shall apply to services furnished on or after 

18 the date of enactment of this Act. 


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1 TITLE IV—PROMOTING BIO2 SPECIMEN COLLECTION TO 

3 ACCELERATE THE GENOMIC 

4 MAPPING OF THE MOST LE5 THAL CANCERS 

6 SEC. 401. ADOPTION OF NATIONAL CANCER INSTITUTE 

7 GUIDELINES FOR BIOREPOSITORIES. 

8 (a) IN GENERAL.—A biorepository may adopt the 

9 First-Generation Guidelines for NCI-Supported Biospeci10 men Resources, published by the National Cancer Insti11 tute of the National Institutes of Health on November 21, 

12 2006 (or any successor guidelines), for the collection of 

13 biospecimens and any accompanying data. 

14 (b) DEFINITIONS.—For purposes of this section: 

15 (1) BIOREPOSITORY.—The term ‘‘bioreposi16 tory’’ means a collection of biological materials 

17 (which may include tissues, biomolecules, body 

18 fluids, and medical imaging) derived from patients, 

19 stored under specifically-defined conditions, and 

20 accessed for the purpose of scientific research or pa21 tient care. 

22 (2) BIOSPECIMEN.—The term ‘‘biospecimen’’ 

23 means any material or medical images of material 

24 that is biologically-derived, such as blood, tissue, and 

25 urine, and used for diagnosis and analysis. 


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1 SEC. 402. MEDPAC REPORT ON PAYMENTS FOR SPECIMEN 

2 COLLECTION. 

3 (a) IN GENERAL.—Not later than 1 year after the 

4 date of enactment of this Act, the Medicare Payment As5 sessment Commission shall submit to Congress a report 

6 (in this section referred to as the ‘‘report’’) on approaches 

7 to developing a payment system within Medicare for the 

8 collection and storage of cancer and related tissues for use 

9 in research involving the application of genomic or 

10 proteomic technologies. 

11 (b) REPORT DETAILS.— 

12 (1) IN GENERAL.—The report shall include rec13 ommendations on the following: 

14 (A) Potential billing code systems for the 

15 collection, storage, and pathological definition 

16 of cancer and related tissues. 

17 (B) Potential payment systems for the col18 lection, storage, and pathological definition of 

19 cancer and related tissues. 

20 (C) The feasibility of expanding the rec21 ommended payment system to cover tissue col22 lection, storage, and pathological definition for 

23 research on conditions unrelated to cancer. 

24 (2) PAYMENT SYSTEMS.—Proposed payment 

25 systems referred to in paragraph (1)(B) shall con26 sider the following factors: 


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1 (A) Numbers and types of cancer tissues 

2 collected for the purpose of research involving 

3 the application of genomic or proteomic tech4 nologies. 

5 (B) Professional time required for patholo6 gists, surgeons, other experts to collect these 

7 tissues for post-genomics research. 

8 (C) Specific annotation of collected tissue 

9 required beyond normal diagnostic needs cur10 rently in practice. 

11 (D) Numbers of tissues collected on gov12 ernment sponsored clinical trials and method of 

13 coverage for the collection of these tissues. 

14 (E) The cost of maintenance of such highly 

15 annotated resources. 

16 (F) The cost of overseeing the standards 

17 needed to ensure that the tissues collected for 

18 molecular oncology research, including the cer19 tification and oversight by a qualified profes20 sional body. 

Æ 


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