205
ployees of the Department to carry out the fol-
lowing:
(A) To oversee the project.
(B) To establish policy and criteria for
medicare disease management programs within
the Department, including the establishment of
policy and criteria for such programs.
(C) To identify targeted medical conditions
and targeted individuals.
(D) To select areas in which such pro-
grams are carried out.
(E) To monitor health outcomes under
such programs.
(F) To measure the effectiveness of such
programs in meeting any budget neutrality re-
quirements.
(G) Otherwise to serve as a central focal
point within the Department for dissemination
of information on medicare disease management
programs.
(d) APPLICATION
OF MEDIGAP PROTECTIONS
TO
DEMONSTRATION PROJECT ENROLLEES.—(1) Subject to
paragraph (2), the provisions of section 1882(s)(3) (other
than clauses (i) through (iv) of subparagraph (B)) and
1882(s)(4) of the Social Security Act shall apply to enroll-
206
ment (and termination of enrollment) in the demonstra-
tion project under this section, in the same manner as they
apply to enrollment (and termination of enrollment) with
a Medicare+Choice organization in a Medicare+Choice
plan.
(2) In applying paragraph (1)—
(A) any reference in clause (v) or (vi) of section
1882(s)(3)(B) of such Act to 12 months is deemed
a reference to the period of the demonstration
project; and
(B) the notification required under section
1882(s)(3)(D) of such Act shall be provided in a
manner specified by the Secretary of Health and
Human Services.
(e) DURATION.—The project shall last for not longer
than 3 years.
(f) WAIVER.—The Secretary of Health and Human
Services shall waive such provisions of title XVIII of the
Social Security Act as may be necessary to provide for
payment for services under the project in accordance with
subsection (c)(3).
(g) REPORT.—The Secretary of Health and Human
Services shall submit to Congress an interim report on the
project not later than 2 years after the date it is first im-
plemented and a final report on the project not later than
207
6 months after the date of its completion. Such reports
shall include information on the impact of the project on
costs and health outcomes and recommendations on the
cost-effectiveness of extending or expanding the project.
(h) GAO STUDY ON DISEASE MANAGEMENT PRO-
GRAMS.—The Comptroller General of the United States
shall conduct a study that compares disease management
programs under title XVIII of the Social Security Act with
such programs conducted in the private sector, including
the prevalence of such programs and programs for case
management. The study shall identify the cost-effective-
ness of such programs and any savings achieved by such
programs. The Comptroller General shall submit a report
on such study to Congress by not later than 18 months
after the date of the enactment of this Act.
SEC. 623. DEMONSTRATION PROJECT FOR MEDICAL ADULT
DAY CARE SERVICES.
(a) ESTABLISHMENT.—Subject to the succeeding
provisions of this section, the Secretary of Health and
Human Services shall establish a demonstration project
(in this section referred to as the ‘‘demonstration project’’)
under which the Secretary shall, as part of a plan of an
episode of care for home health services established for
a medicare beneficiary, permit a medical adult day care
facility or a home health agency, directly or under ar-
208
rangements with a medical adult day care facility, to pro-
vide medical adult day care services as a substitute for
a portion of home health services that would otherwise be
provided in the beneficiary’s home.
(b) PAYMENT.—
(1) IN GENERAL.—The amount of payment for
an episode of care for home health services, a por-
tion of which consists of substitute medical adult
day care services, under the demonstration project
shall be made at a rate equal to 95 percent of the
amount that would otherwise apply for such home
health services under section 1895 of the Social Se-
curity Act (42 u.s.c. 1395fff). In no case may a a
medical adult day care facility or home health agen-
cy, or a medical adult day care facility under ar-
rangements with a home health agency, separately
charge a beneficiary for medical adult day care serv-
ices furnished under the plan of care.
(2) BUDGET
NEUTRALITY
FOR
DEMONSTRA-
TION PROJECT.—Notwithstanding any other provi-
sion of law, the Secretary shall provide for an appro-
priate reduction in the aggregate amount of addi-
tional payments made under section 1895 of the So-
cial Security Act (42 U.S.C. 1395fff) to reflect any
increase in amounts expended from the Trust Funds
209
as a result of the demonstration project conducted
under this section.
(c) DEMONSTRATION PROJECT SITES.—The project
established under this section shall be conducted in not
more than 5 sites in States selected by the Secretary that
license or certify providers of services that furnish medical
adult day care services.
(d) DURATION.—The Secretary shall conduct the
demonstration project for a period of 3 years.
(e) VOLUNTARY PARTICIPATION.—Participation of
medicare beneficiaries in the demonstration project shall
be voluntary. The total number of such beneficiaries that
may participate in the project at any given time may not
exceed 15,000.
(f) PREFERENCE IN SELECTING AGENCIES.—In se-
lecting medical adult day care facilities and home health
agencies to participate under the demonstration project,
the Secretary shall give preference to those facilities and
agencies that—
(1) are currently licensed or certified to furnish
medical adult day care services; and
(2) have furnished medical adult day care serv-
ices to medicare beneficiaries for a continuous 2-year
period before the beginning of the demonstration
project.
210
(g) WAIVER AUTHORITY.—The Secretary may waive
such requirements of title XVIII of the Social Security Act
as may be necessary for the purposes of carrying out the
demonstration project, other than waiving the requirement
that an individual be homebound in order to be eligible
for benefits for home health services.
(h) EVALUATION AND REPORT.—The Secretary shall
conduct an evaluation of the clinical and cost effectiveness
of the demonstration project. Not later 30 months after
the commencement of the project, the Secretary shall sub-
mit to Congress a report on the evaluation, and shall in-
clude in the report the following:
(1) An analysis of the patient outcomes and
costs of furnishing care to the medicare beneficiaries
participating in the project as compared to such out-
comes and costs to beneficiaries receiving only home
health services for the same health conditions.
(2) Such recommendations regarding the exten-
sion, expansion, or termination of the project as the
Secretary determines appropriate.
(i) DEFINITIONS.—In this section:
(1) HOME HEALTH AGENCY.—The term ‘‘home
health agency’’ has the meaning given such term in
section 1861(o) of the Social Security Act (42
U.S.C. 1395x(o)).
211
(2) MEDICAL ADULT DAY CARE FACILITY.—The
term ‘‘medical adult day care facility’’ means a facil-
ity that—
(A) has been licensed or certified by a
State to furnish medical adult day care services
in the State for a continuous 2-year period;
(B) is engaged in providing skilled nursing
services and other therapeutic services directly
or under arrangement with a home health agen-
cy;
(C) meets such standards established by
the Secretary to assure quality of care and such
other requirements as the Secretary finds nec-
essary in the interest of the health and safety
of individuals who are furnished services in the
facility; and
(D) provides medical adult day care serv-
ices.
(3) MEDICAL
ADULT
DAY
CARE
SERVICES.—
The term ‘‘medical adult day care services’’ means—
(A) home health service items and services
described in paragraphs (1) through (7) of sec-
tion 1861(m) furnished in a medical adult day
care facility;
212
(B) a program of supervised activities fur-
nished in a group setting in the facility that—
(i) meet such criteria as the Secretary
determines appropriate; and
(ii) is designed to promote physical
and mental health of the individuals; and
(C) such other services as the Secretary
may specify.
(4) 
MEDICARE
BENEFICIARY.—The 
term
‘‘medicare beneficiary’’ means an individual entitled
to benefits under part A of this title, enrolled under
part B of this title, or both.
SEC. 624. PUBLICATION ON FINAL WRITTEN GUIDANCE
CONCERNING PROHIBITIONS AGAINST DIS-
CRIMINATION BY NATIONAL ORIGIN WITH
RESPECT TO HEALTH CARE SERVICES.
Not later than January 1, 2003, the Secretary shall
issue final written guidance concerning the application of
the prohibition in title VI of the Civil Rights Act of 1964
against national origin discrimination as it affects persons
with limited English proficiency with respect to access to
health care services under the medicare program.
213
TITLE VII—MEDICAID AND
OTHER HEALTH PROVISIONS
Subtitle A—Medicaid Provisions
SEC. 701. DSH PROVISIONS.
(a) CONTINUATION OF MEDICAID DSH ALLOTMENT
ADJUSTMENTS UNDER BIPA2000.—
(1) IN GENERAL.—Section 1923(f) (42 U.S.C.
1396r–4(f))—
(A) in paragraph (2)—
(i) 
in 
the 
heading, 
by 
striking
‘‘THROUGH 2002’’ and inserting ‘‘THROUGH
2000’’;
(ii) by striking ‘‘ending with fiscal
year 2002’’ and inserting ‘‘ending with fis-
cal year 2000’’; and
(iii) in the table in such paragraph, by
striking the columns labeled ‘‘FY 01’’ and
‘‘FY02’’;
(B) in paragraph (3)(A), by striking
‘‘paragraph (2)’’ and inserting ‘‘paragraph
(4)’’; and
(C) in paragraph (4), as added by section
701(a)(1) of BIPA—
(i) by striking ‘‘FOR
FISCAL
YEARS
2001 AND 2002’’ in the heading;
214
(ii) in subparagraph (A), by striking
‘‘Notwithstanding paragraph (2), the’’ and
inserting ‘‘The’’;
(iii) in subparagraph (C)—
(I) by striking ‘‘NO
APPLICA-
TION’’ and inserting ‘‘APPLICATION’’;
and
(II) by striking ‘‘without regard
to’’ and inserting ‘‘taking into ac-
count’’.
(2) INCREASE IN MEDICAID DSH ALLOTMENT
FOR THE DISTRICT OF COLUMBIA.—
(A) IN GENERAL.—Effective for DSH al-
lotments beginning with fiscal year 2002, the
item 
in 
the 
table 
contained 
in 
section
1923(f)(2) of the Social Security Act (42
U.S.C. 1396r–4(f)(2)) for the District of Co-
lumbia for the DSH allotment for FY 00 (fiscal
year 2000) is amended by striking ‘‘32’’ and in-
serting ‘‘49’’.
(B) CONSTRUCTION.—Nothing in subpara-
graph (A) shall be construed as preventing the
application of section 1923(f)(4) of the Social
Security Act (as amended by subsection (a)) to
215
the District of Columbia for fiscal year 2002
and subsequent fiscal years.
(b) INCREASE IN FLOOR FOR TREATMENT AS AN EX-
TREMELY LOW DSH STATE TO 3 PERCENT IN FISCAL
YEAR 2002.—
(1) 
INCREASE
IN
DSH
FLOOR.—Section
1923(f)(5) (42 U.S.C. 1396r–4(f)(5)) is amended—
(A) by striking ‘‘fiscal year 1999’’ and in-
serting ‘‘fiscal year 2001’’;
(B) by striking ‘‘August 31, 2000’’ and in-
serting ‘‘August 31, 2002’’;
(C) by striking ‘‘1 percent’’ each place it
appears and inserting ‘‘3 percent’’; and
(D) by striking ‘‘fiscal year 2001’’ and in-
serting ‘‘fiscal year 2003’’.
(2) EFFECTIVE DATE.—The amendments made
by paragraph (1) take effect on October 1, 2002,
and apply to DSH allotments under title XIX of the
Social Security Act for fiscal year 2003 and each fis-
cal year thereafter.
SEC. 702. 1-YEAR EXTENSION OF Q–I1 PROGRAM.
Section 
1902(a)(10)(E)(E)(iv) 
(42 
U.S.C.
1396a(a)(10)(E)(E)(iv)) is amended by striking ‘‘2002’’
and inserting ‘‘2003’’.
216
Subtitle B—Internet Pharmacies
SEC. 711. INTERNET SALES OF PRESCRIPTION DRUGS.
(a) IN GENERAL.—Chapter 5 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amend-
ed by inserting after section 503A the following section:
‘‘SEC. 503B. INTERNET SALES OF PRESCRIPTION DRUGS.
‘‘(a) REQUIREMENTS REGARDING INFORMATION ON
INTERNET SITE.—
‘‘(1) IN GENERAL.—A person may not dispense
a prescription drug pursuant to a sale of the drug
by such person if—
‘‘(A) the purchaser of the drug submitted
the purchase order for the drug, or conducted
any other part of the sales transaction for the
drug, through an Internet site; and
‘‘(B) such site, or any other Internet site
used by such person for purposes of sales of a
prescription drug, fails to meet each of the re-
quirements specified in paragraph (2) (other
than a site or pages on a site that are not in-
tended to be accessed by purchasers or prospec-
tive purchasers).
‘‘(2) REQUIREMENTS.—With respect to an
Internet site, the requirements referred to in sub-
217
paragraph (B) of paragraph (1) for a person to
whom such paragraph applies are as follows:
‘‘(A) Each page of the site shall include ei-
ther the following information or a link to a
page that provides the following information:
‘‘(i) The name of such person; the ad-
dress of the principal place of business of
the person with respect to sales of pre-
scription drugs through the Internet; and
the telephone number for such place of
business.
‘‘(ii) Each State in which the person
is authorized by law to dispense prescrip-
tion drugs.
‘‘(iii) The name of each individual
who serves as a pharmacist for purposes of
the site, and each State in which the indi-
vidual is authorized by law to dispense pre-
scription drugs.
‘‘(iv) If the person provides for med-
ical consultations through the site for pur-
poses of providing prescriptions, the name
of each individual who provides such con-
sultations; each State in which the indi-
vidual is licensed or otherwise authorized
218
by law to provide such consultations; and
the type or types of health professions for
which the individual holds such licenses or
other authorizations.
‘‘(B) A link to which paragraph (1) applies
shall be clearly visible on the page involved,
shall not be of a size smaller than other links
on the page (if any), and shall include in the
caption for the link the words ‘licensing and
contact information’.
‘‘(b) INTERNET
SALES
WITHOUT
APPROPRIATE
MEDICAL RELATIONSHIPS.—
‘‘(1) IN GENERAL.—A person may not dispense
a prescription drug, or arrange the dispensing of
such a drug, pursuant to a sale of the drug if—
‘‘(A) for purposes of such sale, the pur-
chaser communicated with the person through
the Internet;
‘‘(B) the patient for whom the drug was
purchased did not, when such communications
began, have a prescription for the drug;
‘‘(C) pursuant to such communications, the
person provided for the involvement of a practi-
tioner and the practitioner issued a prescription
for the drug that was purchased;
219
‘‘(D) the person knew, or had reason to
know, that the practitioner did not, when
issuing the prescription, have a qualifying med-
ical relationship with the patient; and
‘‘(E)(i) the person received payment for
the drug from the purchaser; or
‘‘(ii) in the case of arranging the dis-
pensing of the drug, the person received pay-
ment for doing so from the person who dis-
pensed the drug.
For purposes of subparagraph (E), payment is re-
ceived if money or other valuable consideration is re-
ceived.
‘‘(2) QUALIFYING MEDICAL RELATIONSHIP.—
‘‘(A) 
IN
GENERAL.—With 
respect 
to
issuing a prescription for a drug for a patient,
a practitioner has a qualifying medical relation-
ship with the patient for purposes of this sec-
tion if at least one in-person medical evaluation
of the patient has been conducted by the practi-
tioner. This subparagraph and subparagraph
(B) may not be construed as having any appli-
cability beyond this section.
‘‘(B) IN-PERSON MEDICAL EVALUATION.—
A medical evaluation by a practitioner is an in-
220
person medical evaluation for purposes of this
section if the practitioner is in the physical
presence of the patient as part of conducting
the evaluation, without regard to whether por-
tions of the evaluation are conducted by other
health professionals.
‘‘(c) ACTIONS BY STATES.—
‘‘(1) IN GENERAL.—Whenever an attorney gen-
eral of any State has reason to believe that the in-
terests of the residents of that State have been or
are being threatened or adversely affected because
any person has engaged or is engaging in a pattern
or practice that violates section 301(l), the State
may bring a civil action on behalf of its residents in
an appropriate district court of the United States to
enjoin such practice, to enforce compliance with such
section (including a nationwide injunction), to obtain
damages, restitution, or other compensation on be-
half of residents of such State, to obtain reasonable
attorneys fees and costs if the State prevails in the
civil action, or to obtain such further and other relief
as the court may deem appropriate.
‘‘(2) NOTICE.—The State shall serve prior writ-
ten notice of any civil action under paragraph (1) or
(5)(B) upon the Secretary and provide the Secretary
221
with a copy of its complaint, except that if it is not
feasible for the State to provide such prior notice,
the State shall serve such notice immediately upon
instituting such action. Upon receiving a notice re-
specting a civil action, the Secretary shall have the
right—
‘‘(A) to intervene in such action;
‘‘(B) upon so intervening, to be heard on
all matters arising therein; and
‘‘(C) to file petitions for appeal.
‘‘(3) CONSTRUCTION.—For purposes of bring-
ing any civil action under paragraph (1), nothing in
this chapter shall prevent an attorney general of a
State from exercising the powers conferred on the
attorney general by the laws of such State to con-
duct investigations or to administer oaths or affir-
mations or to compel the attendance of witnesses or
the production of documentary and other evidence.
‘‘(4) VENUE; SERVICE OF PROCESS.—Any civil
action brought under paragraph (1) in a district
court of the United States may be brought in the
district in which the defendant is found, is an inhab-
itant, or transacts business or wherever venue is
proper under section 1391 of title 28, United States
Code. Process in such an action may be served in
222
any district in which the defendant is an inhabitant
or in which the defendant may be found.
‘‘(5) ACTIONS BY OTHER STATE OFFICIALS.—
‘‘(A) Nothing contained in this section
shall prohibit an authorized State official from
proceeding in State court on the basis of an al-
leged violation of any civil or criminal statute of
such State.
‘‘(B) In addition to actions brought by an
attorney general of a State under paragraph
(1), such an action may be brought by officers
of such State who are authorized by the State
to bring actions in such State on behalf of its
residents.
‘‘(d) DEFINITIONS.—
‘‘(1) INTERNET-RELATED
DEFINITIONS.—For
purposes of this section:
‘‘(A) The term ‘Internet’ means collectively
the myriad of computer and telecommunications
facilities, including equipment and operating
software, which comprise the interconnected
world-wide network of networks that employ the
transmission control protocol/internet protocol,
or any predecessor or successor protocols to
223
such protocol, to communicate information of
all kinds by wire or radio.
‘‘(B) The term ‘link’, with respect to the
Internet, means one or more letters, words,
numbers, symbols, or graphic items that appear
on a page of an Internet site for the purpose
of serving, when activated, as a method for exe-
cuting an electronic command—
‘‘(i) to move from viewing one portion
of a page on such site to another portion
of the page;
‘‘(ii) to move from viewing one page
on such site to another page on such site;
or
‘‘(iii) to move from viewing a page on
one Internet site to a page on another
Internet site.
‘‘(C) The term ‘page’, with respect to the
Internet, means a document or other file
accessed at an Internet site.
‘‘(D)(i) The terms ‘site’ and ‘address’, with
respect to the Internet, mean a specific location
on the Internet that is determined by Internet
Protocol numbers. Such term includes the do-
main name, if any.
224
‘‘(ii) The term ‘domain name’ means a
method of representing an Internet address
without direct reference to the Internet Protocol
numbers for the address, including methods
that use designations such as ‘.com’, ‘.edu’,
‘.gov’, ‘.net’, or ‘.org’.
‘‘(iii) The term ‘Internet Protocol num-
bers’ includes any successor protocol for deter-
mining a specific location on the Internet.
‘‘(2) OTHER
DEFINITIONS.—For purposes of
this section:
‘‘(A) The term ‘practitioner’, with respect
to the issuance of a prescription for a drug for
a patient, means—
‘‘(i) an individual authorized by law to
administer the drug; or
‘‘(ii) an individual who is not so au-
thorized but represents himself or herself
as an individual who is so authorized.
‘‘(B) The term ‘prescription drug’ means a
drug that is subject to section 503(b).
‘‘(C) The term ‘qualifying medical relation-
ship’, with respect to a practitioner and a pa-
tient, has the meaning indicated for such term
in subsection (b).’’.
225
(b) INCLUSION AS PROHIBITED ACT.—Section 301 of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
331) is amended by inserting after paragraph (k) the fol-
lowing:
‘‘(l) The dispensing of a prescription drug in violation
of section 503B, or arranging for the dispensing of such
a drug in violation of such section.’’.
SEC. 712. INTERNET SALES OF PRESCRIPTION DRUGS; CON-
SIDERATION BY SECRETARY OF PRACTICES
AND PROCEDURES FOR CERTIFICATION OF
LEGITIMATE BUSINESSES.
In carrying out section 503B of the Federal Food,
Drug, and Cosmetic Act (as added by section 711 of this
Act), the Secretary of Health and Human Services shall
take into consideration the practices and procedures of
public or private entities that certify that businesses sell-
ing prescription drugs through Internet sites are legiti-
mate businesses, including practices and procedures re-
garding disclosure formats and verification programs.
SEC. 713. EFFECTIVE DATE.
The amendments made by section 711 take effect
upon the expiration of the 60-day period beginning on the
date of the enactment of this Act, without regard to
whether a final rule to implement such amendments has
been promulgated by the Secretary of Health and Human
226
Services under section 701(a) of the Federal Food, Drug,
and Cosmetic Act. The preceding sentence may not be con-
strued as affecting the authority of such Secretary to pro-
mulgate such a final rule.
Subtitle C—Treatment of Rare
Diseases
SEC. 721. NIH OFFICE OF RARE DISEASES AT NATIONAL IN-
STITUTES OF HEALTH.
Title IV of the Public Health Service Act (42 U.S.C.
281 et seq.), as amended by Public Law 107–84, is
amended by inserting after section 404E the following:
‘‘OFFICE OF RARE DISEASES
‘‘SEC. 404F. (a) ESTABLISHMENT.—There is estab-
lished within the Office of the Director of NIH an office
to be known as the Office of Rare Diseases (in this section
referred to as the ‘Office’), which shall be headed by a
Director (in this section referred to as the ‘Director’), ap-
pointed by the Director of NIH.
‘‘(b) DUTIES.—
‘‘(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 ac-
227
tivities, including scientific workshops and
symposia to identify research opportunities for
rare diseases.
‘‘(B) The Director shall, with respect to
rare diseases, promote coordination and co-
operation among the national research insti-
tutes and centers and entities whose research is
supported by such institutes.
‘‘(C) The Director, in collaboration with
the directors of the other relevant institutes and
centers of the National Institutes of Health,
may enter into cooperative agreements with and
make grants for regional centers of excellence
on rare diseases in accordance with section
404G.
‘‘(D) The Director shall promote the suffi-
cient allocation of the resources of the National
Institutes of Health for conducting and sup-
porting research on rare diseases.
‘‘(E) The Director shall promote and en-
courage the establishment of a centralized
clearinghouse for rare and genetic disease infor-
mation that will provide understandable infor-
mation about these diseases to the public, med-
ical professionals, patients and families.
228
‘‘(F) The Director shall biennially prepare
a report that describes the research and edu-
cation activities on rare diseases being con-
ducted or supported through the national re-
search institutes and centers, and that identi-
fies particular projects or types of projects that
should in the future be conducted or supported
by the national research institutes and centers
or other entities in the field of research on rare
diseases.
‘‘(G) The Director shall prepare the NIH
Director’s annual report to Congress on rare
disease research conducted by or supported
through the national research institutes and
centers.
‘‘(2) PRINCIPAL ADVISOR REGARDING ORPHAN
DISEASES.—With respect to rare diseases, the Direc-
tor shall serve as the principal advisor to the Direc-
tor of NIH and shall provide advice to other relevant
agencies. The Director shall provide liaison with na-
tional and international patient, 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.
229
‘‘(d) AUTHORIZATION OF APPROPRIATIONS.—For the
purpose of carrying out this section, there are authorized
to be appropriated such sums as already have been appro-
priated for fiscal year 2002, and $4,000,000 for each of
the fiscal years 2003 through 2006.’’.
SEC. 722. 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 721, is further amend-
ed 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 institutes and centers of the National
Institutes of Health, may enter into cooperative
agreements with and make grants to public or pri-
vate 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
excellence for clinical research into, training in, and
demonstration of diagnostic, prevention, control, and
treatment methods for rare diseases.
230
‘‘(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 Director shall coordinate the activities under this sec-
tion with similar activities conducted by other national re-
search institutes, centers and agencies of the National In-
stitutes of Health and by the Food and Drug Administra-
tion to the extent that such institutes, centers and agen-
cies have responsibilities that are related to rare diseases.
‘‘(c) USES FOR FEDERAL PAYMENTS UNDER COOP-
ERATIVE AGREEMENTS OR GRANTS.—Federal payments
made under a cooperative agreement or grant under sub-
section (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 al-
lied health professionals, continuing education for
health professionals and allied health professions
personnel, and information programs for the public
with respect to rare diseases; and
‘‘(3) clinical research and demonstration pro-
grams.
231
‘‘(d) PERIOD OF SUPPORT; ADDITIONAL PERIODS.—
Support of a center under subsection (a) may be for a
period of not to exceed 5 years. Such period may be ex-
tended by the Director 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 Director and if such group
has recommended to the Director that such period should
be extended.
‘‘(e) AUTHORIZATION OF APPROPRIATIONS.—For the
purpose of carrying out this section, there are authorized
to be appropriated such sums as already have been appro-
priated for fiscal year 2002, and $20,000,000 for each of
the fiscal years 2003 through 2006.’’.
Subtitle D—Other Provisions
Relating to Drugs
SEC. 731. GAO STUDY REGARDING DIRECT-TO-CONSUMER
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
increases in utilization rates of prescription drugs
that are attributable to guidance regarding direct-to-
consumer advertising of such drugs that has been
232
issued by the Food and Drug Administration under
section 502(n) of the Federal Food, Drug, and Cos-
metic Act; and
(2) if so, whether and to what extent such in-
creased utilization rates have resulted in increases in
the costs of public or private health plans, health in-
surance, or other health programs.
(b) CERTAIN DETERMINATIONS.—The study under
subsection (a) shall include determinations of the fol-
lowing:
(1) The extent to which advertisements referred
to in such subsection have resulted in effective con-
sumer education about the prescription drugs in-
volved, including an understanding of the risks of
the drugs relative to the benefits.
(2) The extent of consumer satisfaction with
such advertisements.
(3) The extent of physician satisfaction with the
advertisements, including determining whether phy-
sicians believe that the advertisements interfere with
the exercise of their medical judgment by influencing
consumers to prefer advertised drugs over alter-
native therapies.
(4) The extent to which the advertisements
have resulted in increases in health care costs for
233
taxpayers, for employers, or for consumers due to
consumer decisions to seek advertised drugs rather
than lower-costs alternative therapies.
(5) The extent to which the advertisements
have resulted in decreases in health care costs for
taxpayers, for employers, or for consumers due to
decreased hospitalization rates, fewer physician visits
(not related to hospitalization), lower treatment
costs, or reduced instances of employee 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. 732. CERTAIN HEALTH PROFESSIONS PROGRAMS RE-
GARDING 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 following 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 adver-
tise and promote the pharmacist profession, high-
234
light the advantages and rewards of being a phar-
macist, and encourage individuals to enter the phar-
macist profession.
‘‘(2) METHOD.—The public service announce-
ments described in subsection (a) shall be broadcast
through appropriate media outlets, including tele-
vision or radio, in a manner intended to reach as
wide and diverse an audience as possible.
‘‘(b) STATE
AND LOCAL PUBLIC SERVICE AN-
NOUNCEMENTS.—
‘‘(1) IN GENERAL.—The Secretary shall award
grants to entities to support State and local adver-
tising campaigns through appropriate media outlets
to promote the pharmacist profession, highlight the
advantages and rewards of being a pharmacist, and
encourage individuals from disadvantaged back-
grounds 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 advertisements in local newspapers,
and post information on billboards or on the Inter-
net, in order to—
‘‘(A) advertise and promote the pharmacist
profession;
235
‘‘(B) promote pharmacist education pro-
grams;
‘‘(C) inform the public of public assistance
regarding such education programs;
‘‘(D) highlight individuals in the commu-
nity that are presently practicing as phar-
macists to recruit new pharmacists; and
‘‘(E) provide any other information to re-
cruit individuals for the pharmacist profession.
‘‘(3) METHOD.—The campaigns described in
subsection (a) shall be broadcast on television or
radio, placed in newspapers as advertisements, or
posted on billboards or the Internet, in a manner in-
tended to reach as wide and diverse an audience as
possible.
‘‘SEC. 772. DEMONSTRATION PROJECT.
‘‘(a) IN GENERAL.—The Secretary shall establish a
demonstration project to enhance the participation of indi-
viduals who are pharmacists in the National Health Serv-
ice Corps Loan Repayment Program described in section
338B.
‘‘(b) SERVICES.—Services that may be provided by
pharmacists pursuant to the demonstration project estab-
lished under this section include medication therapy man-
agement services to assure that medications are used ap-
236
propriately by patients, to enhance patients’ under-
standing of the appropriate use of medications, to increase
patients’ adherence to prescription medication regimens,
to reduce the risk of adverse events associated with medi-
cations, and to reduce the need for other costly medical
services through better management of medication ther-
apy. Such services may include case management, disease
management, drug therapy management, patient training
and education, counseling, drug therapy problem resolu-
tion, medication administration, the provision of special
packaging, or other services that enhance the use of pre-
scription medications.
‘‘(c) PROCEDURE.—The Secretary may not provide
assistance to an individual under this section unless the
individual agrees to comply with all requirements de-
scribed in sections 338B and 338E.
‘‘(d) LIMITATIONS.—The demonstration project de-
scribed 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 properly analyze the effectiveness of such project.
‘‘(e) DESIGNATIONS.—The demonstration project de-
scribed in this section, and any pharmacists who are se-
237
lected to participate in such project, shall not be consid-
ered by the Secretary in the designation of a health profes-
sional 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 described in this section.
‘‘(g) REPORT.—The Secretary shall prepare and sub-
mit a report on the project to—
‘‘(1) the Committee on Health, Education,
Labor, and Pensions of the Senate;
‘‘(2) the Subcommittee on Labor, Health and
Human Services, and Education of the Committee
on Appropriations of the Senate;
‘‘(3) the Committee on Energy and Commerce
of the House of Representatives; and
‘‘(4) the Subcommittee on Labor, Health and
Human Services, and Education of the Committee
on Appropriations of the House of Representatives.
‘‘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 installing computer-based systems to pro-
vide 
pharmaceutical 
education. 
Education 
provided
238
through such systems may be graduate education, profes-
sional education, or continuing education. The computer-
based systems may be designed to provide on-site edu-
cation, or education at remote sites (commonly referred
to as distance learning), or both.
‘‘(b) QUALIFYING SCHOOL OF PHARMACY.—For pur-
poses of this section, the term ‘qualifying school of phar-
macy’ 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.’’.
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