245
‘‘(1) IN GENERAL.—The Director of the Office shall
carry out the following:
‘‘(A) The Director shall recommend an agenda for
conducting and supporting research on rare diseases
through the national research institutes and centers.
The agenda shall provide for a broad range of research
and education activities, including scientific workshops
and symposia to identify research opportunities for rare
diseases.
‘‘(B) The Director shall, with respect to rare dis-
eases, promote coordination and cooperation among the
national research institutes and centers and entities
whose research is supported by such institutes.
‘‘(C) The Director, in collaboration with the direc-
tors of the other relevant institutes and centers of the
National Institutes of Health, may enter into coopera-
tive agreements with and make grants for regional cen-
ters of excellence on rare diseases in accordance with
section 404G.
‘‘(D) The Director shall promote the sufficient al-
location of the resources of the National Institutes of
Health for conducting and supporting research on rare
diseases.
‘‘(E) The Director shall promote and encourage
the establishment of a centralized clearinghouse for
rare and genetic disease information that will provide
understandable information about these diseases to the
public, medical professionals, patients and families.
‘‘(F) The Director shall biennially prepare a re-
port that describes the research and education activities
on rare diseases being conducted or supported through
the national research institutes and centers, and that
identifies particular projects or types of projects that
should in the future be conducted or supported by the
national research institutes and centers or other enti-
ties in the field of research on rare diseases.
246
‘‘(G) The Director shall prepare the NIH Direc-
tor’s annual report to Congress on rare disease re-
search conducted by or supported through the national
research institutes and centers.
‘‘(2) PRINCIPAL
ADVISOR
REGARDING
ORPHAN
DIS-
EASES.—With respect to rare diseases, the Director shall
serve as the principal advisor to the Director of NIH and
shall provide advice to other relevant agencies. The Direc-
tor shall provide liaison with national and international pa-
tient, health and scientific organizations concerned with
rare diseases.
‘‘(c) DEFINITION.—For purposes of this section, the term
‘rare disease’ means any disease or condition that affects less
than 200,000 persons in the United States.
‘‘(d) AUTHORIZATION OF APPROPRIATIONS.—For the pur-
pose of carrying out this section, there are authorized to be ap-
propriated such sums as already have been appropriated for fis-
cal year 2002, and $4,000,000 for each of the fiscal years 2003
through 2006.’’.
SEC. 932. RARE DISEASE REGIONAL CENTERS OF EXCEL-
LENCE.
Title IV of the Public Health Service Act (42 U.S.C. 281
et seq.), as amended by section 1021, is further amended by
inserting after section 404F the following:
‘‘RARE DISEASE REGIONAL CENTERS OF EXCELLENCE
‘‘SEC. 404G. (a) COOPERATIVE
AGREEMENTS
AND
GRANTS.—
‘‘(1) IN GENERAL.—The Director of the Office of Rare
Diseases (in this section referred to as the ‘Director’), in
collaboration with the directors of the other relevant insti-
tutes and centers of the National Institutes of Health, may
enter into cooperative agreements with and make grants to
public or private nonprofit entities to pay all or part of the
cost of planning, establishing, or strengthening, and pro-
viding basic operating support for regional centers of excel-
lence for clinical research into, training in, and demonstra-
247
tion of diagnostic, prevention, control, and treatment meth-
ods for rare diseases.
‘‘(2) POLICIES.—A cooperative agreement or grant
under paragraph (1) shall be entered into in accordance
with policies established by the Director of NIH.
‘‘(b) COORDINATION WITH OTHER INSTITUTES.—The Di-
rector shall coordinate the activities under this section with
similar activities conducted by other national research insti-
tutes, centers and agencies of the National Institutes of Health
and by the Food and Drug Administration to the extent that
such institutes, centers and agencies have responsibilities that
are related to rare diseases.
‘‘(c) USES FOR FEDERAL PAYMENTS UNDER COOPERA-
TIVE AGREEMENTS
OR GRANTS.—Federal payments made
under a cooperative agreement or grant under subsection (a)
may be used for—
‘‘(1) staffing, administrative, and other basic operating
costs, including such patient care costs as are required for
research;
‘‘(2) clinical training, including training for allied
health professionals, continuing education for health profes-
sionals and allied health professions personnel, and infor-
mation programs for the public with respect to rare dis-
eases; and
‘‘(3) clinical research and demonstration programs.
‘‘(d) PERIOD OF SUPPORT; ADDITIONAL PERIODS.—Sup-
port of a center under subsection (a) may be for a period of
not to exceed 5 years. Such period may be extended by the Di-
rector for additional periods of not more than 5 years if the
operations of such center have been reviewed by an appropriate
technical and scientific peer review group established by the Di-
rector and if such group has recommended to the Director that
such period should be extended.
‘‘(e) AUTHORIZATION OF APPROPRIATIONS.—For the pur-
pose of carrying out this section, there are authorized to be ap-
propriated such sums as already have been appropriated for fis-
248
cal year 2002, and $20,000,000 for each of the fiscal years
2003 through 2006.’’.
Subtitle E—Other Provisions
Relating to Drugs
SEC. 941. GAO STUDY REGARDING DIRECT-TO-CON-
SUMER 
ADVERTISING 
OF 
PRESCRIPTION
DRUGS.
(a) IN GENERAL.—The Comptroller General of the United
States shall conduct a study for the purpose of determining—
(1) whether and to what extent there have been in-
creases in utilization rates of prescription drugs that are
attributable to guidance regarding direct-to-consumer ad-
vertising of such drugs that has been issued by the Food
and Drug Administration under section 502(n) of the Fed-
eral Food, Drug, and Cosmetic Act; and
(2) if so, whether and to what extent such increased
utilization rates have resulted in increases in the costs of
public or private health plans, health insurance, or other
health programs.
(b) CERTAIN DETERMINATIONS.—The study under sub-
section (a) shall include determinations of the following:
(1) The extent to which advertisements referred to in
such subsection have resulted in effective consumer edu-
cation about the prescription drugs involved, including an
understanding of the risks of the drugs relative to the bene-
fits.
(2) The extent of consumer satisfaction with such ad-
vertisements.
(3) The extent of physician satisfaction with the ad-
vertisements, including determining whether physicians be-
lieve that the advertisements interfere with the exercise of
their medical judgment by influencing consumers to prefer
advertised drugs over alternative therapies.
(4) The extent to which the advertisements have re-
sulted in increases in health care costs for taxpayers, for
employers, or for consumers due to consumer decisions to
249
seek advertised drugs rather than lower-costs alternative
therapies.
(5) The extent to which the advertisements have re-
sulted in decreases in health care costs for taxpayers, for
employers, or for consumers due to decreased hospitaliza-
tion rates, fewer physician visits (not related to hospitaliza-
tion), lower treatment costs, or reduced instances of em-
ployee absences to care for family members with diseases
or disorders.
(c) REPORT.—Not later than two years after the date of
the enactment of this Act, the Comptroller General of the
United States shall submit to the Congress a report providing
the findings of the study under subsection (a).
SEC. 942. CERTAIN HEALTH PROFESSIONS PROGRAMS
REGARDING PRACTICE OF PHARMACY.
Part E of title VII of the Public Health Service Act (42
U.S.C. 294n et seq.) is amended by adding at the end the fol-
lowing subpart:
‘‘Subpart 3—Pharmacist Workforce Programs
‘‘SEC. 771. PUBLIC SERVICE ANNOUNCEMENTS.
‘‘(a) PUBLIC SERVICE ANNOUNCEMENTS.—
‘‘(1) IN GENERAL.—The Secretary shall develop and
issue public service announcements that advertise and pro-
mote the pharmacist profession, highlight the advantages
and rewards of being a pharmacist, and encourage individ-
uals to enter the pharmacist profession.
‘‘(2) METHOD.—The public service announcements de-
scribed in subsection (a) shall be broadcast through appro-
priate media outlets, including television or radio, in a
manner intended to reach as wide and diverse an audience
as possible.
‘‘(b) STATE
AND LOCAL PUBLIC SERVICE ANNOUNCE-
MENTS.—
‘‘(1) IN GENERAL.—The Secretary shall award grants
to entities to support State and local advertising campaigns
through appropriate media outlets to promote the phar-
macist profession, highlight the advantages and rewards of
250
being a pharmacist, and encourage individuals to enter the
pharmacist profession.
‘‘(2) USE OF FUNDS.—An entity that receives a grant
under subsection (a) shall use funds received through such
grant to acquire local television and radio time, place ad-
vertisements in local newspapers, and post information on
billboards or on the Internet, in order to—
‘‘(A) advertise and promote the pharmacist profes-
sion;
‘‘(B) promote pharmacist education programs;
‘‘(C) inform the public of public assistance regard-
ing such education programs;
‘‘(D) highlight individuals in the community that
are presently practicing as pharmacists to recruit new
pharmacists; and
‘‘(E) provide any other information to recruit indi-
viduals for the pharmacist profession.
‘‘(3) METHOD.—The campaigns described in sub-
section (a) shall be broadcast on television or radio, placed
in newspapers as advertisements, or posted on billboards or
the Internet, in a manner intended to reach as wide and
diverse an audience as possible.
‘‘SEC. 772. DEMONSTRATION PROJECT.
‘‘(a) IN GENERAL.—The Secretary shall establish a dem-
onstration project to enhance the participation of individuals
who are pharmacists in the National Health Service Corps
Loan Repayment Program described in section 338B.
‘‘(b) SERVICES.—Services that may be provided by phar-
macists pursuant to the demonstration project established
under this section include medication therapy management
services to assure that medications are used appropriately by
patients, to enhance patients’ understanding of the appropriate
use of medications, to increase patients’ adherence to prescrip-
tion medication regimens, to reduce the risk of adverse events
associated with medications, and to reduce the need for other
costly medical services through better management of medica-
tion therapy. Such services may include case management, dis-
251
ease management, drug therapy management, patient training
and education, counseling, drug therapy problem resolution,
medication administration, the provision of special packaging,
or other services that enhance the use of prescription medica-
tions.
‘‘(c) PROCEDURE.—The Secretary may not provide assist-
ance to an individual under this section unless the individual
agrees to comply with all requirements described in sections
338B and 338D.
‘‘(d) LIMITATIONS.—The demonstration project described
in this section shall provide for the participation of—
‘‘(1) individuals to provide services in rural and urban
areas; and
‘‘(2) enough individuals to allow the Secretary to prop-
erly analyze the effectiveness of such project.
‘‘(e) DESIGNATIONS.—The demonstration project de-
scribed in this section, and any pharmacists who are selected
to participate in such project, shall not be considered by the
Secretary in the designation of a health professional shortage
area under section 332 during fiscal years 2003 through 2005.
‘‘(f) RULE OF CONSTRUCTION.—This section shall not be
construed to require any State to participate in the project de-
scribed in this section.
‘‘(g) REPORT.—The Secretary shall prepare and submit a
report on the project to—
‘‘(A) the Committee on Health, Education, Labor,
and Pensions of the Senate;
‘‘(B) the Subcommittee on Labor, Health and
Human Services, and Education of the Committee on
Appropriations of the Senate;
‘‘(C) the Committee on Energy and Commerce of
the House of Representatives; and
‘‘(D) the Subcommittee on Labor, Health and
Human Services, and Education of the Committee on
Appropriations of the House of Representatives.
252
‘‘SEC. 773. INFORMATION TECHNOLOGY.
‘‘(a) GRANTS AND CONTRACTS.—The Secretary may make
awards of grants or contracts to qualifying schools of pharmacy
for the purpose of assisting such schools in acquiring and in-
stalling computer-based systems to provide pharmaceutical edu-
cation. Education provided through such systems may be grad-
uate education, professional education, or continuing education.
The computer-based systems may be designed to provide on-site
education, or education at remote sites (commonly referred to
as distance learning), or both.
‘‘(b) QUALIFYING SCHOOL OF PHARMACY.—For purposes
of this section, the term ‘qualifying school of pharmacy’ means
a school of pharmacy (as defined in section 799B) that requires
students to serve in a clinical rotation in which pharmacist
services are part of the curriculum.
‘‘SEC. 774. AUTHORIZATION OF APPROPRIATIONS.
‘‘For the purpose of carrying out this subpart, there are
authorized to be appropriated such sums as may be necessary
for each of the fiscal years 2003 through 2006.’’.
TITLE X—HEALTH-CARE RELATED
TAX PROVISIONS
SEC. 1001. ELIGIBILITY FOR ARCHER MSA’S EXTENDED
TO 
ACCOUNT 
HOLDERS 
OF
MEDICARE+CHOICE MSA’S.
(a) IN GENERAL.—Subparagraph (B) of section 220(c)(2)
of the Internal Revenue Code of 1986 is amended by adding
at the end the following new clause:
‘‘(iii) MEDICARE+CHOICE MSA’S.—In the case
of an individual who is covered under an MSA plan
(as defined in section 1859(b)(3) of the Social Se-
curity Act) which such individual elected under sec-
tion 1851(a)(2)(B) of such Act—
‘‘(I) such plan shall be treated as a high
deductible health plan for purposes of this sec-
tion,
253
‘‘(II) subsection (b)(2)(A) shall be applied
by substituting ‘100 percent’ for ‘65 percent’
with respect to such individual,
‘‘(III) with respect to such individual, the
limitation under subsection (d)(1)(A)(ii) shall
be 100 percent of the highest annual deductible
limitation under section 1859(b)(3)(B) of the
Social Security Act,
‘‘(IV) paragraphs (4), (5), and (7) of sub-
section (b) and paragraph (1)(A)(iii) of this
subsection shall not apply with respect to such
individual, and
‘‘(V) the limitation which would (but for
this subclause) apply under subsection (b)(1)
with respect to such individual for any taxable
year shall be reduced (but not below zero) by
the amount which would (but for subsection
106(b)) be includible in such individual’s gross
income for the taxable year.’’.
(b) ACCOUNTS NOT COUNTED AGAINST NUMERICAL LIM-
ITS.—
(1) IN GENERAL.—Paragraph (3) of section 220(j) of
such Code is amended—
(A) in the heading, by striking ‘‘PREVIOUSLY UN-
INSURED’’ and inserting ‘‘CERTAIN’’,
(B) in subparagraph (A), by striking ‘‘by not
counting the Archer MSA of any previously uninsured
individual.’’ and inserting ‘‘by not counting—
‘‘(i) the Archer MSA of any previously unin-
sured individual, and
‘‘(ii) the Archer MSA of any eligible individual
who qualifies as such an individual by reason of
subsection (c)(2)(B)(iii).’’.
(2) REPORTING REQUIREMENT.—Subparagraph (A) of
section 220(j)(4) of such Code is amended in clause (ii) by
striking ‘‘and’’ at the end, in clause (iii) by striking the pe-
254
riod and inserting ‘‘, and’’, and by adding at the end the
following new clause:
‘‘(iv) the number of such accounts which are
accounts of eligible individuals who qualify as such
individuals by reason of subsection (c)(2)(B)(iii).’’.
(c) EFFECTIVE DATE.—The amendments made by this
section shall apply to taxable years beginning after December
31, 2002.
SEC. 1002. ADJUSTMENT OF EMPLOYER CONTRIBU-
TIONS TO COMBINED BENEFIT FUND TO RE-
FLECT 
MEDICARE 
PRESCRIPTION 
DRUG
SUBSIDY PAYMENTS.
Section 9704(b) of the Internal Revenue Code of 1986 (re-
lating to health benefit premium) is amended by adding at the
end the following new paragraph:
‘‘(4) ADJUSTMENTS
FOR
MEDICARE
PRESCRIPTION
DRUG
SUBSIDIES.—The trustees of the Combined Fund
shall decrease the per beneficiary premium for each plan
year in which a subsidy payment is provided to it under
section 1860H of the Social Security Act by the amount
which would place the Combined Fund in the same finan-
cial position as if such subsidy payment had not been re-
ceived.’’.
SEC. 1003. EXPANSION OF HUMAN CLINICAL TRIALS
QUALIFYING FOR ORPHAN DRUG CREDIT.
(a) IN GENERAL.—Paragraph (2) of section 45C(b) of the
Internal Revenue Code of 1986 is amended by adding at the
end the following new subparagraph:
‘‘(C) TREATMENT
OF
CERTAIN
EXPENSES
IN-
CURRED BEFORE DESIGNATION.—For purposes of sub-
paragraph (A)(ii)(I), if a drug is designated under sec-
tion 526 of the Federal Food, Drug, and Cosmetic Act
not later than the due date (including extensions) for
filing the return of tax under this subtitle for the tax-
able year in which the application for such designation
of such drug was filed, such drug shall be treated as
having been designated on the date that such applica-
tion was filed.’’.