H. R. 5213

One Hundred Eighth Congress

of the

United States of America

AT THE SECOND SESSION

Begun and held at the City of Washington on Tuesday,

the twentieth day of January, two thousand and four

An Act

To expand research information regarding multidisciplinary research projects and

epidemiological studies.

Be it enacted by the Senate and House of Representatives of

the United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

This Act may be cited as the ‘‘Research Review Act of 2004’’.

SEC. 2. MULTI-DISCIPLINARY RESEARCH TEAM AND CONSORTIA

REPORT.

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

(referred to in this Act as the ‘‘Secretary’’), in coordination with

the Director of the National Institutes of Health, shall prepare

a report outlining the methods by which the Roadmap for Medical

Research, an initiative of such Institutes, has advanced the use

of multidisciplinary research teams and consortia of research

institutions to advance treatments, develop new therapies, and

collaborate on clinical trials, including with respect to spinal cord

injury and paralysis research.

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

shall submit the report under subsection (a) to the Committee

on Energy and Commerce of the House of Representatives and

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

the Senate.

SEC. 3. EPIDEMIOLOGICAL STUDY REPORT.

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

of the Centers for Disease Control and Prevention, shall prepare

a report outlining the epidemiological studies currently under way

at such Centers, future planned studies, the criteria involved in

determining what epidemiological studies to conduct, defer, or suspend, and the scope of those studies, including with respect to

the inflammatory bowel disease epidemiological study. The report

shall include a description of the activities the Centers for Disease

Control and Prevention undertakes to establish partnerships with

research and patient advocacy communities to expand epidemiological studies.

(b) REPORT.—Not later than May 1, 2005, the Secretary shall

submit the report under subsection (a) to the Committee on Energy

and Commerce of the House of Representatives and to the Committee on Health, Education, Labor, and Pensions of the Senate.
H. R. 5213—2

SEC. 4. STUDY BY GOVERNMENT ACCOUNTABILITY OFFICE ON MEDICARE AND MEDICAID COVERAGE STANDARDS.

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

shall conduct a study on the coverage standards that, under the

programs under titles XVIII and XIX of the Social Security Act

(commonly known as Medicare and Medicaid, respectively), apply

to patients with inflammatory bowel disease for the following therapies:

(1) Parenteral nutrition.

(2) Enteral nutrition formula.

(3) Medically necessary food products.

(4) Ostomy supplies.

(5) Therapies approved by the Food and Drug Administration for Crohn’s disease and ulcerative colitis.

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

account the appropriate outpatient or home health care delivery

settings.

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

enactment of this Act, the Comptroller General shall submit to

the Congress a report describing the findings of the study under

subsection (a).

SEC. 5. STUDY BY GOVERNMENT ACCOUNTABILITY OFFICE INVOLVING

DISABILITY INSURANCE.

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

shall conduct a study of the problems patients encounter when

applying for disability insurance benefits under title II of the Social

Security Act. The study shall include recommendations for

improving the application process for patients with inflammatory

bowel disease.

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

enactment of this Act, the Comptroller General shall submit to

the Congress a report describing the findings of the study under

subsection (a).

Speaker of the House of Representatives.

Vice President of the United States and

President of the Senate.