President
Bush signed H.R. 3926, the Organ Donation & Recovery Improvement
Act, on April 5, 2004
President
Bush signed H.R. 3926, the Organ Donation & Recovery Improvement
Act, on April 5, 2004 (Public Law 108-216). The National Kidney Foundation
(NKF) worked with the sponsors to help craft the final bill. Despite
the steady increase in organ donation (primarily from living donors),
the need for organs for transplantation continues to far outweigh availability.
There are almost 85,000 Americans on the waiting list to receive an
organ as of April 2004.
A key provision of the legislation establishes a federal grant program
to provide assistance to living donors with travel and subsistence expenses
and incidental nonmedical expenses incurred by individuals toward making
living organ donations. This provision has been an NKF priority. The
NKF believes in the principle that living organ donors should not personally
bear any financial costs associated with donation. Moreover, the NKF
maintains that removing the financial barriers associated with donation
could possibly expand access to transplantation for members of lower
socio-economic groups who are often precluded from considering living
donation.
The legislation also grants money to states for organ donor awareness,
public education and outreach activities designed to increase the number
of organ donors. It will also award grants to organ procurement organizations
and hospitals to establish programs coordinating organ donation activities
to increase the rate of organ donations for such hospitals. Other provisions
of the legislation require the Secretary of Health and Human Services
(HHS) to establish a public education program to increase awareness
about organ donation and the need to provide for an adequate rate of
donation and to support the development and dissemination of educational
materials to inform health care professionals about organ, tissue, and
eye donation issues. H.R. 3926 authorizes the Secretary to establish
mechanisms to evaluate the long-term effects associated with living
organ donations.
The bill also requires the Secretary of Health and Human Services to
submit a report to Congress that evaluates the ethical implications
of proposals to increase non-living donation, which could include financial
incentives. However, it does not authorize demonstration projects to
examine whether financial incentives would increase non-living donation.
A previous Senate version of the legislation would have permitted such
demonstration projects, but a successful advocacy effort by NKF resulted
in the removal of the provision. Many transplant societies and organizations
supported the demonstration authority (because of their belief that
incentives could ease the organ shortage or because they believe the
issue should be studied and resolved).
Issue Background
Research conducted by the National Kidney Foundation’s Council
of Nephrology Social Workers (CNSW) indicates that 25% of potential
donors are hesitant to donate because of potential financial burden
incurred by the living donor and that a similar percentage of living
donors regretted their decision because of the economic consequences.
The National Kidney Foundation applauds Congress for taking the step
forward to assist living organ donors with financial burdens often associated
with donation. NKF will continue to support efforts aimed at increasing
the donor pool.
In addition to payment for travel and subsistence, the Foundation is
a strong supporter of organ donor leave policies. Modeled after federal
law, for federal employees, many states have begun to offer state employees
up to 30 days paid leave for serving as a living organ donor; this leave
is considered separate from any annual or sick leave already accrued
by an employee.
If you have questions about H.R. 3926, about financial assistance for
living donors, organ donor leave or other issues related to organ donation
and transplantation please contact the NKF Government Relations Division
at (800) 889-9559.
To read text of the law, please scroll to the bottom
of the page:
More
Legislative Initiatives
Legislation Introduced in the
108th Congress
ORGAN DONATION
HR 399 "Organ Donation Improvement Act of 2003
Representative Michael Bilirakis (R-FL)
This bill would award grants/contracts to States, transplant centers,
qualified OPO's, public or private entities for the travel and non-medical
expenses incurred by individuals for living donation. It would (through
grants) implement a public education program regarding organ donation,
including living donation. It would provide for grants to public and
nonprofit entities for demonstration projects to increase organ donation.
S. 186 "Living Organ Donor Protections
Act" Senator Mike DeWine (R-OH)
This bill would prohibit health insurance discrimination (for those
covered by group premiums) for individuals who are or become living
organ donors.
S. 178 "Comprehensive Immunosuppressive
Drug Coverage for Transplant Patients Act of 2003 Senator Richard Durbin
(D-IL)
This bill would essentially extend immunosuppressive drug coverage to
those with End-Stage-Renal disease. It would continue prescription drug
coverage for immunosuppressive drugs for those who received a kidney
or other organ for which payment was made under Medicare, and extends
it to Medicare secondary payer requirements for End-Stage Renal Disease
beneficiaries.
S. 376 "DONATE Act" Senator
Richard Durbin (D-IL)
This appears to be a re-introduction of his legislation from last year.
It includes:
1. Establishment of an organ and tissue donor registry - establishment
of a National Organ and Tissue Donor Registry with the duties of the
Center being to advance development/expansion of State registries; exchange
of information between centers; develop consensus on model registry
models; provide technical assistance to States on establishment and
operation of State registries; maintain a clearinghouse to collect and
disseminate best practice information; and provide grants for state
registries.
2. Establishment of a "Advisory Task Force" (membership of
10 - a physician, a member with experience in organ procurement, 2 members
with experience in conducting national awareness campaigns and donor
outreach, 2 members representing States with donor registries, member
with experience in information systems, and a member of a donor family).
The charge for the Task Force appears to be to produce a report on best
practices for state registries.
3. Provision of money for living donors' travel and
medical expenses
4. Establishment of a public education program about organ donation
5. Provision of congressional medals for organ donors (or families)
6. Provision of an IOM report on organ donation practices
7. Provision of grants to hospitals or OPO's to increase organ donation,
and to see how certain entities have increased donation
CLONING
H.R. 801 "Cloning Prohibition Act of 2003"
Representative Jim Greenwood (R-PA)
This legislation would prohibit human cloning but allow human somatic
cell nuclear transfer technology (allow research on therapeutic issues
for cloning/stem cell research).
H.R. 916 Representative Cliff Stearns
(R-FL)
This legislation would prohibit the use of federal funds for cloning
of humans and establish equivalent restrictions for other countries.
H.R. 534 "Human Cloning Prohibition
Act of 2003" Representative Dave Weldon (R-FL)
This legislation bans all cloning research.
S. 303 "Human Cloning Ban and
Stem Cell Research Protection Act of 2003" Senator Orrin Hatch
(R-UT)
This legislation opposes human cloning but allows stem cell research.
S. 245 "Human Cloning Prohibition
Act of 2003" - Senator Sam Brownback (R-KS)
This legislation would ban all cloning research.
NURSING RELATED
H.R. 745 and S. 373 Representative
Pete Stark (D-CA) and Senator Edward Kennedy (D-MA)
This legislation would place limitations on mandatory overtime for nurses
and protect nurses against retaliation.
Look
up any bill in the Senate and or in The US House Of Representatives
LI
TRIO's Link to THOMAS, a place to find Legislative
Information Online
The
following is some background information (with
respect
to Transplantation) compiled
from the UCongress:
Nutritional
Counseling for Kidney Transplant Recipients
Included in the Beneficiary
Improvements and Protection Act (BIPA) signed into law in
December, 2000 is a provision
providing for Medicare coverage for nutritional counseling for pre-dialysis
and post-transplant patients.
This has been in effect
since January 1, 2002.
The provision authorizes
nutritional counseling for beneficiaries
with diabetes and kidney disease. The legislation
is based
upon recommendations from an Institute of Medicine panel which, in turn,
had received documentation from NKF in support of this benefit. Special
thanks are due to the hardworking staff and volunteers of the NKF.
Indefinite Medicare
Coverage of Immunosuppressive Drugs for Aged and Disabled
On December 21, 2000,
President Clinton signed into law the Beneficiary Improvements
and Protection Act (BIPA)
or
Public Law 106-554.
It provides Medicare coverage
of immunosuppressive medications
without a
time limitation for those
65 or older and for
those transplant recipients receiving Social Security Disability Income
payments for
as long as their transplant is viable. Transplant recipients who are
not aged or
whose disability is based solely on their End Stage Renal Disease (ESRD)
are unfortunately not eligible for this indefinite coverage. These individuals
would continue to receive Medicare
coverage for their anti-rejection
medications for 36 months following
their transplant.
The original bill before
it became President signed it into law:
Assistance for Living
Donors
The need for organs for transplantation continues to far outweigh availability.
There are currently over 82,000 Americans on the waiting list to receive
an organ and the increase in organ donation over the last decade was
due almost entirely to tremendous growth in the number of living organ
donors during that period. The National Kidney Foundation (NKF), believes
strongly in the principle that living organ donors should not personally
bear any financial costs associated with donation and has therefore
made living donor financial disincentives a priority for advocacy.
Moreover, the NKF maintains that removing the financial barriers associated
with donation could possibly expand access to transplantation for members
of lower socio-economic groups who, unfortunately, have been less likely
to be listed for transplant.
Representative Michael Bilirakis (R-FL) introduced H.R. 399; one provision
of that bill would provide grants and contracts to states, transplant
centers and qualified organ procurement organizations to assist with
payment of travel and subsistence expenses incurred by living organ
donors. The bill sets forth payment eligibility criteria and limitations,
including that the payments for the qualifying donor only apply if the
state of the donating individual and the state of the intended recipient
are different. In addition, the annual income of the organ recipient
cannot exceed $35,000. The bill passed the House of Representatives
on March 12, 2003 by a vote of 425-3 and has been referred to the Senate
Health, Education, Labor & Pensions Committee.
Senator Bill Frist (R-TN) has also introduced legislation aimed at alleviating
financial disincentives for living donors; S. 573 contains a provision
that, much like the Bilirakis bill, provides grants to states and other
entities to assist with payment for travel and subsistence expenses.
However, the Frist provision does not establish an income limit for
the transplant recipient nor does it stipulate guidelines regarding
interstate or intrastate travel.
Issue Background
The rate of living donation in the United States has increased 123%
over the last decade. Despite this increase, the gap between the need
for organs and their availability continues to widen. Research conducted
by the National Kidney Foundation's Council of Nephrology Social Workers
indicates that 25% of potential donors are hesitant to donate because
of the financial burden often incurred by the living donor and that
a similar percentage of living donors regretted their decision because
of the economic consequences.
The National Kidney Foundation will continue to support efforts aimed
at increasing the donor pool. In addition to payment for travel and
subsistence, the Foundation is a strong supporter of organ donor leave
policies. Modeled after federal law, for federal employees, many states
have begun to offer state employees up to 30 days paid leave for serving
as a living organ donor; this leave is considered separate from any
annual or sick leave already accrued by an employee.
If you have questions about H.R. 399, S. 573 or about financial assistance
for living donors, please contact the NKF Government Relations Division
at (800) 889-9559 or to see the bills in their entirety visit http://thomas.loc.gov.
The following bill is currently in committee
in the U.S. House of Representatives.
Medicare Fairness for Organ Transplant
Recipients Act of 2003 Introduced in House
HR 588 IH
108th CONGRESS 1st Session H.
R. 588
To amend title XVIII of the Social Security Act to provide for coverage
under the Medicare Program of immunosuppressive drugs for Medicare beneficiaries
who receive an organ transplant without regard to when the
transplant was received.
On February 5, 2003, Mr. LATOURETTE introduced the following
bill; which was referred to the Committee on Ways and Means, and in
addition to the Committee on Energy and Commerce, 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 amend title XVIII of the Social Security Act to provide for coverage
under the Medicare Program of immunosuppressive drugs for Medicare beneficiaries
who receive an organ transplant without regard to when the transplant
was received.
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 `Medicare Fairness for Organ
Transplant Recipients Act of 2003'.SEC. 2. COVERAGE OF IMMUNOSUPPRESSIVE
DRUGS FOR MEDICARE BENEFICIARIES WITHOUT REGARD TO WHEN AN ORGAN TRANSPLANT
OCCURRED.(a) IN GENERAL- Section 1861(s)(2)(J) of the Social Security
Act (42 U.S.C. 1395x(s)(2)(J)) is amended by striking `for which payment
is made under this title'.(b) STYLISTIC AMENDMENT- Such section is further
amended by striking the comma after `furnished'.(c) EFFECTIVE DATE-
The amendments made by this section shall apply to drugs furnished on
or after the date of the enactment of this Act.
Thanks to The
NKF Government Relations Division
Prescription Drug and Medicare
Improvement Act of 2003
On Passage of the Bill 06/26/2003
Senate Roll Call No. 262 108th Congress, 1st Session
Passed: 76-21
By yeas to nays (Vote No. 262), Senate passed S. 1, to amend title XVIII
of the Social Security Act to make improvements in the Medicare program,
to provide prescription drug coverage under the Medicare program, after
agreeing to the committee amendment in the nature of a substitute.
Medicare prescription drug benefit legislation passes
House and Senate
Challenges lie ahead as Congress reconciles differences
in two versions.
By a one-vote margin in the House of Representatives and a comfortable
margin in the Senate, Congress passed bills that would create a federal
prescription drug benefit for Medicare beneficiaries. While differences
between the two houses' versions must be worked out in conference, elderly
Americans appear likely to have drug coverage beginning in 2006.More:
Medicare Bill Is Tough Medicine
CRAWFORD, Texas-2003
(AP / CBS)
"At this juncture, we've got to get this right. We can't afford
to make mistakes or miss any details."
Majority Leader Sen. Bill Frist, R-Tenn.
The Medicare changes will be almost as historic as its creation. Above:
LBJ signs the bill, as Harry Truman checks his watch for the exact time,
as their wives and Hubert Humphrey look on. (AP (file))
(CBS/AP) Ready to sign Medicare reform legislation and hand it
to voters, President Bush asked lawmakers to quickly resolve their differences
and offer America's seniors prescription drug coverage for the first
time in the program's 38-year history.
"The Congress must now pass a final bill that makes the Medicare
system work better for America's seniors," Mr. Bush said in his
Saturday radio address taped before he arrived at his Texas ranch for
the weekend.
"This is an issue of vital importance to senior citizens all across
our country. They have waited years for a modern Medicare system and
they should not have to wait any longer." More:
| Here
is another opinion from medicareadvocacy.org |
THE TRUTH ABOUT THE MEDICARE PRESCRIPTION
DRUG LEGISLATION
------------------------------------------------------------------------
HIDDEN CHANGES TO THE MEDICARE PROGRAM
S. 1 and H.R. 1, the prescription drug legislation that passed the Senate
and the House of Representatives, respectively, on June 27, 2003, do
more than add a prescription drug benefit to Medicare. Both bills make
substantial changes to the Medicare program, including imposing additional
costs on beneficiaries for current Medicare services. Both bills increase
reliance on private insurance to provideMedicare services. These changes
are so dramatic in scope that, given the inadequacy of the prescription
drug benefits proposed, they raise serious questions about the overall
merits of both bills.
DID YOU KNOW THAT:
*
Both bills are designed to force elders and people with disabilities
who rely on Medicare into HMOs and other private insurance plans.* More:
MEDICARE DRUG BILLS PASS IN HOUSE AND SENATE
Medicare prescription drug legislation passed in both chambers of Congress
early Friday, but negotiators face major differences between the bi-partisan
Senate measure and the bill largely backed by Republicans that barely
passed in the House.
June 17, 2003
More than in the Senate bill,
the House bill creates economic incentives for seniors to leave traditional
Medicare and enter a private managed-care plan. After 2010, it also
changes the way Medicare sets its prices, giving a far greater role
to private sector competition.Democrats say the movement will lead to
the privatization of Medicare.More:
H.R.3926 : To amend the Public Health Service Act to
promote organ donation, and for other purposes.
Sponsor: Rep Bilirakis, Michael [FL-9] (introduced 3/10/2004) Cosponsors
(8)
Committees: House Energy and Commerce
Latest Major Action: Became Public Law No: 108-216 [GPO:DOCID:
f:publ216.108]
[[Page 583]]
ORGAN DONATION AND RECOVERY IMPROVEMENT ACT
[[Page 118 STAT. 584]]
Public Law 108-216
108th Congress
An Act
To amend the Public Health Service Act to promote organ donation, and
for other purposes. <<NOTE: Apr. 5, 2004 - [H.R. 3926}>>
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress <<NOTE: Organ Donation and
Recovery
Improvement Act.>> assembled,
SECTION 1. <<NOTE: 42 USC 201 note.>> SHORT TITLE.
This Act may be cited as the ``Organ Donation and Recovery
Improvement Act''.
SEC. 2. SENSE OF CONGRESS.
(a) Public Awareness of Need for Organ Donation.--It is the sense of
Congress that the Federal Government should carry out programs to
educate the public with respect to organ donation, including the need
to
provide for an adequate rate of such donations.
(b) Family Discussions of Organ Donations.--Congress recognizes the
importance of families pledging to each other to share their lives as
organ and tissue donors and acknowledges the importance of discussing
organ and tissue donation as a family.
(c) Living Donations of Organs.--Congress--
(1) recognizes the generous contribution made by each living
individual who has donated an organ to save a life; and
(2) acknowledges the advances in medical technology that
have enabled organ transplantation with organs donated by living
individuals to become a viable treatment option for an
increasing number of patients.
SEC. 3. REIMBURSEMENT OF TRAVEL AND SUBSISTENCE EXPENSES INCURRED TOWARD
LIVING ORGAN DONATION.
Section 377 of the Public Health Service Act (42 U.S.C. 274f) is
amended to read as follows:
``SEC. 377. REIMBURSEMENT OF TRAVEL AND SUBSISTENCE EXPENSES INCURRED
TOWARD LIVING ORGAN DONATION.
``(a) In General.--The Secretary may award grants to States,
transplant centers, qualified organ procurement organizations under
section 371, or other public or private entities for the purpose of--
``(1) providing for the reimbursement of travel and
subsistence expenses incurred by individuals toward making
living donations of their organs (in this section referred to as
`donating individuals'); and
``(2) providing for the reimbursement of such incidental
nonmedical expenses that are so incurred as the Secretary
determines by regulation to be appropriate.
[[Page 118 STAT. 585]]
``(b) Preference.--The Secretary shall, in carrying out subsection
(a), give preference to those individuals that the Secretary determines
are more likely to be otherwise unable to meet such expenses.
``(c) Certain Circumstances.--The Secretary may, in carrying out
subsection (a), consider--
``(1) the term `donating individuals' as including
individuals who in good faith incur qualifying expenses toward
the intended donation of an organ but with respect to whom, for
such reasons as the Secretary determines to be appropriate, no
donation of the organ occurs; and
``(2) the term `qualifying expenses' as including the
expenses of having relatives or other individuals, not to exceed
2, accompany or assist the donating individual for purposes of
subsection (a) (subject to making payment for only those types
of expenses that are paid for a donating individual).
``(d) Relationship to Payments Under Other Programs.--An award may
be made under subsection (a) only if the applicant involved agrees that
the award will not be expended to pay the qualifying expenses of a
donating individual to the extent that payment has been made, or can
reasonably be expected to be made, with respect to such expenses--
``(1) under any State compensation program, under an
insurance policy, or under any Federal or State health benefits
program;
``(2) by an entity that provides health services on a
prepaid basis; or
``(3) by the recipient of the organ.
``(e) Definitions.--For purposes of this section:
``(1) The term `donating individuals' has the meaning
indicated for such term in subsection (a)(1), subject to
subsection (c)(1).
``(2) The term `qualifying expenses' means the expenses
authorized for purposes of subsection (a), subject to subsection
(c)(2).
``(f) Authorization of Appropriations.--For the purpose of carrying
out this section, there is authorized to be appropriated $5,000,000
for
each of the fiscal years 2005 through 2009.''.
SEC. 4. PUBLIC AWARENESS; STUDIES AND DEMONSTRATIONS.
Part H of title III of the Public Health Service Act (42 U.S.C. 273
et seq.) is amended by inserting after section 377 the following:
``SEC. 377A. <<NOTE: Grants. Contracts. 42 USC 274f-1.>>
PUBLIC
AWARENESS; STUDIES AND DEMONSTRATIONS.
``(a) Organ Donation Public Awareness Program.--The Secretary shall,
directly or through grants or contracts, establish a public education
program in cooperation with existing national public awareness campaigns
to increase awareness about organ donation and the need to provide for
an adequate rate of such donations.
``(b) Studies and Demonstrations.--The Secretary may make peer-
reviewed grants to, or enter into peer-reviewed contracts with, public
and nonprofit private entities for the purpose of carrying out studies
and demonstration projects to increase organ donation and recovery
rates, including living donation.
``(c) Grants to States.--
``(1) In general.--The Secretary may make grants to States
for the purpose of assisting States in carrying out organ
[[Page 118 STAT. 586]]
donor awareness, public education, and outreach activities and
programs designed to increase the number of organ donors within
the State, including living donors.
``(2) Eligibility.--To be eligible to receive a grant under
this subsection, a State shall--
``(A) submit an application to the Department in the
form prescribed;
``(B) establish yearly benchmarks for improvement in
organ donation rates in the State; and
``(C) <<NOTE: Reports.>> report to the Secretary on
an annual basis a description and assessment of the
State's use of funds received under this subsection,
accompanied by an assessment of initiatives for
potential replication in other States.
``(3) Use of funds.--Funds received under this subsection
may be used by the State, or in partnership with other public
agencies or private sector institutions, for education and
awareness efforts, information dissemination, activities
pertaining to the State donor registry, and other innovative
donation specific initiatives, including living donation.
``(d) Educational Activities.--The Secretary, in coordination with
the Organ Procurement and Transplantation Network and other appropriate
organizations, shall support the development and dissemination of
educational materials to inform health care professionals and other
appropriate professionals in issues surrounding organ, tissue, and eye
donation including evidence-based proven methods to approach patients
and their families, cultural sensitivities, and other relevant issues.
``(e) Authorization of Appropriations.--For the purpose of carrying
out this section, there are authorized to be appropriated $15,000,000
for fiscal year 2005, and such sums as may be necessary for each of
the
fiscal years 2006 through 2009. Such authorization of appropriations
is
in addition to any other authorizations of appropriations that are
available for such purpose.
``SEC. 377B. <<NOTE: 42 USC 274f-2.>> GRANTS REGARDING HOSPITAL
ORGAN
DONATION COORDINATORS.
``(a) Authority.--
``(1) In general.--The Secretary may award grants to
qualified organ procurement organizations and hospitals under
section 371 to establish programs coordinating organ donation
activities of eligible hospitals and qualified organ procurement
organizations under section 371. Such activities shall be
coordinated to increase the rate of organ donations for such
hospitals.
``(2) Eligible hospital.--For purposes of this section, the
term `eligible hospital' means a hospital that performs
significant trauma care, or a hospital or consortium of
hospitals that serves a population base of not fewer than
200,000 individuals.
``(b) Administration of Coordination Program.--A condition for the
receipt of a grant under subsection (a) is that the applicant involved
agree that the program under such subsection will be carried out
jointly--
``(1) by representatives from the eligible hospital and the
qualified organ procurement organization with respect to which
the grant is made; and
``(2) by such other entities as the representatives referred
to in paragraph (1) may designate.
[[Page 118 STAT. 587]]
``(c) Requirements.--Each entity receiving a grant under subsection
(a) shall--
``(1) establish joint organ procurement organization and
hospital designated leadership responsibility and accountability
for the project;
``(2) develop mutually agreed upon overall project
performance goals and outcome measures, including interim
outcome targets; and
``(3) collaboratively design and implement an appropriate
data collection process to provide ongoing feedback to hospital
and organ procurement organization leadership on project
progress and results.
``(d) Rule of Construction.--Nothing in this section shall be
construed to interfere with regulations in force on the date of
enactment of the Organ Donation and Recovery Improvement Act.
``(e) Evaluations.--Within <<NOTE: Deadline.>> 3 years after
the
award of grants under this section, the Secretary shall ensure an
evaluation of programs carried out pursuant to subsection (a) in order
to determine the extent to which the programs have increased the rate
of
organ donation for the eligible hospitals involved.
``(f) Matching Requirement.--The Secretary may not award a grant to
a qualifying organ donation entity under this section unless such entity
agrees that, with respect to costs to be incurred by the entity in
carrying out activities for which the grant was awarded, the entity
shall contribute (directly or through donations from public or private
entities) non-Federal contributions in cash or in kind, in an amount
equal to not less than 30 percent of the amount of the grant awarded
to
such entity.
``(g) Funding.--For the purpose of carrying out this section, there
are authorized to be appropriated $3,000,000 for fiscal year 2005, and
such sums as may be necessary for each of fiscal years 2006 through
2009.''.
SEC. 5. STUDIES RELATING TO ORGAN DONATION AND THE RECOVERY,
PRESERVATION, AND TRANSPORTATION OF ORGANS.
Part H of title III of the Public Health Service Act (42 U.S.C. 273
et seq.) is amended by inserting after section 377B, as added by section
4, the following:
``SEC. 377C. <<NOTE: 42 USC 274f-3.>> STUDIES RELATING TO
ORGAN DONATION
AND THE RECOVERY, PRESERVATION, AND TRANSPORTATION OF
ORGANS.
``(a) Development of Supportive Information.--The Secretary, acting
through the Director of the Agency for Healthcare Research and Quality,
shall develop scientific evidence in support of efforts to increase
organ donation and improve the recovery, preservation, and
transportation of organs.
``(b) Activities.--In carrying out subsection (a), the Secretary
shall--
``(1) conduct or support evaluation research to determine
whether interventions, technologies, or other activities improve
the effectiveness, efficiency, or quality of existing organ
donation practice;
``(2) undertake or support periodic reviews of the
scientific literature to assist efforts of professional
societies to ensure that the clinical practice guidelines that
they develop reflect the latest scientific findings;
[[Page 118 STAT. 588]]
``(3) ensure that scientific evidence of the research and
other activities undertaken under this section is readily
accessible by the organ procurement workforce; and
``(4) work in coordination with the appropriate professional
societies as well as the Organ Procurement and Transplantation
Network and other organ procurement and transplantation
organizations to develop evidence and promote the adoption of
such proven practices.
``(c) Research and Dissemination.--The Secretary, acting through the
Director of the Agency for Healthcare Research and Quality, as
appropriate, shall provide support for research and dissemination of
findings, to--
``(1) develop a uniform clinical vocabulary for organ
recovery;
``(2) apply information technology and telecommunications to
support the clinical operations of organ procurement
organizations;
``(3) enhance the skill levels of the organ procurement
workforce in undertaking quality improvement activities; and
``(4) assess specific organ recovery, preservation, and
transportation technologies.
``(d) Authorization of Appropriations.--For the purpose of carrying
out this section, there are authorized to be appropriated $2,000,000
for
fiscal year 2005, and such sums as may be necessary for each of fiscal
years 2006 through 2009.''.
SEC. 6. REPORT RELATING TO ORGAN DONATION AND THE RECOVERY,
PRESERVATION, AND TRANSPORTATION OF ORGANS.
Part H of title III of the Public Health Service Act (42 U.S.C. 273
et seq.) is amended by inserting after section 377C, as added by section
5, the following:
``SEC. 377D. <<NOTE: 42 USC 274f-4.>> REPORT RELATING TO
ORGAN DONATION
AND THE RECOVERY, PRESERVATION, AND TRANSPORTATION OF
ORGANS.
``(a) In General.--Not <<NOTE: Deadline.>> later than December
31,
2005, and every 2 years thereafter, the Secretary shall report to the
appropriate committees of Congress on the activities of the Department
carried out pursuant to this part, including an evaluation describing
the extent to which the activities have affected the rate of organ
donation and recovery.
``(b) Requirements.--To the extent practicable, each report
submitted under subsection (a) shall--
``(1) evaluate the effectiveness of activities, identify
effective activities, and disseminate such findings with respect
to organ donation and recovery;
``(2) assess organ donation and recovery activities that are
recently completed, ongoing, or planned; and
``(3) evaluate progress on the implementation of the plan
required under subsection (c)(5).
``(c) Initial Report Requirements.--The initial report under
subsection (a) shall include the following:
``(1) An evaluation of the organ donation practices of organ
procurement organizations, States, other countries, and other
appropriate organizations including an examination across all
populations, including those with low organ donation rates, of--
``(A) existing barriers to organ donation; and
[[Page 118 STAT. 589]]
``(B) the most effective donation and recovery
practices.
``(2) An evaluation of living donation practices and
procedures. Such evaluation shall include an assessment of
issues relating to informed consent and the health risks
associated with living donation (including possible reduction of
long-term effects).
``(3) An evaluation of--
``(A) federally supported or conducted organ
donation efforts and policies, as well as federally
supported or conducted basic, clinical, and health
services research (including research on preservation
techniques and organ rejection and compatibility); and
``(B) the coordination of such efforts across
relevant agencies within the Department and throughout
the Federal Government.
``(4) An evaluation of the costs and benefits of State donor
registries, including the status of existing State donor
registries, the effect of State donor registries on organ
donation rates, issues relating to consent, and recommendations
regarding improving the effectiveness of State donor registries
in increasing overall organ donation rates.
``(5) A plan to improve federally supported or conducted
organ donation and recovery activities, including, when
appropriate, the establishment of baselines and benchmarks to
measure overall outcomes of these programs. Such plan shall
provide for the ongoing coordination of federally supported or
conducted organ donation and research activities.''.
SEC. 7. NATIONAL LIVING DONOR MECHANISMS.
Part H of title III of the Public Health Service Act (42 U.S.C. 273
et seq.) is amended by inserting after section 371 the following:
``SEC. 371A. <<NOTE: 42 USC 273a.>> NATIONAL LIVING DONOR
MECHANISMS.
``The Secretary may establish and maintain mechanisms to evaluate
the long-term effects associated with living organ donations by
individuals who have served as living donors.''.
SEC. 8. <<NOTE: Deadline. Reports.>> STUDY.
Not later than December 31, 2004, the Secretary of Health and Human
Services, in consultation with appropriate entities, including advocacy
groups representing those populations that are likely to be
disproportionately affected by proposals to increase cadaveric donation,
shall submit to the appropriate committees of Congress a report that
evaluates the ethical implications of such proposals.
[[Page 118 STAT. 590]]
SEC. 9. QUALIFIED ORGAN PROCUREMENT ORGANIZATIONS.
Section 371(a) of the Public Health Service Act (42 U.S.C. 273(a))
is amended by striking paragraph (3).
Approved April 5, 2004.
LEGISLATIVE HISTORY--H.R. 3926:
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CONGRESSIONAL RECORD, Vol. 150 (2004):
Mar. 23, 24, considered and passed House.
Mar. 25, considered and passed Senate.
