I 

108TH CONGRESS 

2D SESSION H. R. 5213 

To expand research information regarding multidisciplinary research projects 

and epidemiological studies. 

IN THE HOUSE OF REPRESENTATIVES 

OCTOBER 5, 2004 

Mr. BILIRAKIS (for himself and Mrs. KELLY) introduced the following bill; 

which was referred to the Committee on Energy and Commerce, and in 

addition to the Committee on 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 expand research information regarding multidisciplinary 

research projects and epidemiological studies. 

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

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Research Review Act 

5 of 2004’’. 

6 SEC. 2. MULTI-DISCIPLINARY RESEARCH TEAM AND CON7 SORTIA REPORT. 

8 (a) IN GENERAL.—The Secretary of Health and 

9 Human Services (referred to in this Act as the ‘‘Sec-
2 

•HR 5213 IH 

1 retary’’), in coordination with the Director of the National 

2 Institutes of Health, shall prepare a report outlining the 

3 methods by which the Roadmap for Medical Research, an 

4 initiative of such Institutes, has advanced the use of multi5 disciplinary research teams and consortia of research in6 stitutions to advance treatments, develop new therapies, 

7 and collaborate on clinical trials, including with respect 

8 to spinal cord injury and paralysis research. 

9 (b) REPORT.—Not later than February 1, 2005, the 

10 Secretary shall submit the report under subsection (a) to 

11 the Committee on Energy and Commerce of the House 

12 of Representatives and to the Committee on Health, Edu13 cation, Labor, and Pensions of the Senate. 

14 SEC. 3. EPIDEMIOLOGICAL STUDY REPORT. 

15 (a) IN GENERAL.—The Secretary, acting through the 

16 Director of the Centers for Disease Control and Preven17 tion, shall prepare a report outlining the epidemiological 

18 studies currently underway at such Centers, future 

19 planned studies, the criteria involved in determining what 

20 epidemiological studies to conduct, defer, or suspend, and 

21 the scope of those studies, including with respect to the 

22 inflammatory bowel disease epidemiological study. The re23 port shall include a description of the activities the Cen24 ters for Disease Control and Prevention undertakes to es-
3 

•HR 5213 IH 

1 tablish partnerships with research and patient advocacy 

2 communities to expand epidemiological studies. 

3 (b) REPORT.—Not later than February 1, 2005, the 

4 Secretary shall submit the report under subsection (a) to 

5 the Committee on Energy and Commerce of the House 

6 of Representatives and to the Committee on Health, Edu7 cation, Labor, and Pensions of the Senate. 

8 SEC. 4. STUDY BY GOVERNMENT ACCOUNTABILITY OFFICE 

9 ON MEDICARE AND MEDICAID COVERAGE 

10 STANDARDS. 

11 (a) IN GENERAL.—The Comptroller General of the 

12 United States shall conduct a study on the coverage stand13 ards that, under the programs under titles XVIII and XIX 

14 of the Social Security Act (commonly known as Medicare 

15 and Medicaid, respectively), apply to patients with inflam16 matory bowel disease for the following therapies: 

17 (1) Parenteral nutrition. 

18 (2) Enteral nutrition formula. 

19 (3) Medically necessary food products. 

20 (4) Ostomy supplies. 

21 (5) Therapies approved by the Food and Drug 

22 Administration for Crohn’s disease and ulcerative 

23 colitis. 
4 

•HR 5213 IH 

1 (b) CONTENT.—The study under subsection (a) shall 

2 take into account the appropriate outpatient or home 

3 health care delivery settings. 

4 (c) REPORT.—Not later than six months after the 

5 date of the enactment of this Act, the Comptroller General 

6 shall submit to the Congress a report describing the find7 ings of the study under subsection (a). 

8 SEC. 5. STUDY BY GOVERNMENT ACCOUNTABILITY OFFICE 

9 INVOLVING DISABILITY INSURANCE. 

10 (a) IN GENERAL.—The Comptroller General of the 

11 United States shall conduct a study of the problems pa12 tients encounter when applying for disability insurance 

13 benefits under title II of the Social Security Act. The 

14 study shall include recommendations for improving the ap15 plication process for patients with inflammatory bowel dis16 ease. 

17 (b) REPORT.—Not later than six months after the 

18 date of the enactment of this Act, the Comptroller General 

19 shall submit to the Congress a report describing the find20 ings of the study under subsection (a). 

Æ