[Federal Register Volume 70, Number 225 (Wednesday, November 23, 2005)]
[Proposed Rules]
[Pages 70765-70768]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-23149]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration

42 CFR Part 121

RIN 0906AA62


Organ Procurement and Transplantation Network

AGENCY: Health Resources and Services Administration, HHS.

ACTION: Notice of proposed rulemaking.

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SUMMARY: This notice sets forth the Secretary's proposal to include 
intestines within the definition of organs covered by the rules 
governing the operation of the Organ Procurement and Transplantation 
Network. The Secretary further proposes a corresponding change to the 
definition of human organs covered by section 301 of the National Organ 
Transplant Act, as amended.

DATES: To be considered, comments on this proposed rule must be 
submitted by January 23, 2006. Subject to consideration of the comments 
submitted, the Department intends to publish final regulations.

ADDRESSES: You may submit comments, identified by RIN 0906AA62, by any 
of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments.
     Agency Web site: http://www.hrsa.gov/. Follow the 
instructions for submitting comments on the Agency Web site.
     E-mail: [email protected]. Include RIN 0906AA62 in the 
subject line of the message.
     Fax: 301-594-6095.
     Mail: Jim Burdick, M.D., Director, Division of 
Transplantation, Healthcare Systems Bureau, Health Resources and 
Services Administration (HRSA), 5600 Fishers Lane, Room 12C-06, 
Rockville, Maryland 20857.
     Hand Delivery/Courier: Jim Burdick, M.D., Director, 
Division of Transplantation, Healthcare Systems Bureau, Health 
Resources and Services Administration (HRSA), 5600 Fishers Lane, Room 
12C-06, Rockville, Maryland 20857.
    Instructions: All submissions received must include the agency name 
and Regulatory Information Number (RIN) for this rulemaking. All 
comments received will be posted without change to http://www.hrsa.gov/
, including any personal information provided. For detailed 
instructions on submitting comments and additional information on the 
rulemaking process, see the ``Public Participation'' heading of the 
SUPPLEMENTARY INFORMATION section of this document.
    Docket: For access to the docket to read background documents or 
comments received, go to the Division of Transplantation, Healthcare 
Systems Bureau, Health Resources and Services Administration (HRSA), 
5600 Fishers Lane, Room 12C-06, Rockville, Maryland 20857 weekdays 
(Federal holidays excepted) between the hours of 8:30 a.m. and 5 p.m. 
To schedule an appointment to view public comments, phone (301) 443-
7757.

FOR FURTHER INFORMATION CONTACT: Jim Burdick, M.D. at the above 
address; telephone number (301) 443-7577.

SUPPLEMENTARY INFORMATION:

Adding Intestines to the Definition of Organs Covered by the Rules 
Governing the Operation of the Organ Procurement and Transplantation 
Network (OPTN)

    Based upon a review of intestinal transplants, the Secretary 
believes that intestines should now be included within the definition 
of organs covered by the rules governing the operation of the OPTN (42 
CFR part 121) (hereinafter the final rule). This notice sets forth the 
history of intestinal transplants, the factors that have persuaded the 
Department of the advisability of including intestines within the ambit 
of the regulations governing the operation of the OPTN, and the 
anticipated consequences of this proposal.
    The first successful intestinal transplant was performed in 1989. 
Intestinal transplantation may be considered for patients with 
irreversible intestinal failure due to surgery, trauma, or acquired or 
congenital disease who cannot be managed through the intravenous 
delivery of nutrients, also referred to as total parenteral nutrition 
(TPN). Although intestinal transplants have been performed for years, 
considerable morbidity and mortality have limited widespread clinical 
use. Complications are frequent and include acute and chronic 
rejection, lymphoproliferative disease, and serious infections such as 
cytomegalovirus disease. For patients who received intestinal 
transplants in the United States from January 2000 through June 2002, 
one-year graft and patient survival rates were 67 percent and 81 
percent respectively for adults, and 58 percent and 65 percent 
respectively for pediatric recipients. Despite the shortcomings, the 
number of candidates for intestinal transplants and the number of 
intestinal

[[Page 70766]]

transplants performed annually is increasing.
    The OPTN first adopted voluntary intestinal organ allocation 
policies and began to maintain a list of patients waiting for 
intestinal transplants in 1993. On December 31, 1993, only 43 
candidates were listed on the intestinal transplant waiting list, 
compared to 169 candidates on this list on October 24, 2003. The number 
of intestinal transplants performed annually has more than tripled from 
34 transplants in 1993 to 109 transplants in 2002. However, the volume 
of transplants per transplant center is relatively small. Ten 
transplant centers performed one or more intestinal transplants in 
2002; only five of these centers performed ten or more transplants. 
Overall median waiting time was 319 days for patients added to the 
intestinal transplant waiting list in 2001.
    According to the OPTN, intestinal organ allocation may include the 
stomach, small and/or large intestine, or any portion of the 
gastrointestinal tract as determined by the medical needs of individual 
patients (OPTN Policy 3.11). OPTN voluntary policies are available at 
http://www.optn.org/policiesandbylaws/policies.asp. In addition to 
allocation for isolated intestinal transplants, the OPTN addresses 
allocation of the liver-intestine combination and multiple organs.
    The nature of the regulatory framework governing the operation of 
the OPTN underlies the importance of including intestines within the 
definition of organs covered by the final rule. Under the final rule, 
the OPTN must submit proposed policies for review and approval by the 
Secretary. 42 CFR 121.4. Upon consideration of public comments on 
proposed policies that are considered significant, the Secretary will 
determine whether to make such proposed policies enforceable in 
accordance with Sec.  121.10 of the final rule. Any transplant hospital 
that fails to comply with any allocation policy approved as enforceable 
by the Secretary under this process will be subject to the enforcement 
sanctions delineated in Sec.  121.10 of the rule, including termination 
from the Medicare and Medicaid programs.
    The Secretary is legally obliged, as part of his responsibilities 
in administering the Medicare and Medicaid programs, to require 
hospitals that transplant organs to comply with the rules and 
requirements of the OPTN as a condition of their participation in 
Medicare and Medicaid. 42 U.S.C. 1320b-8(a)(1)(B). Because intestines 
are not included within the final rule's definition of organs, the 
Secretary cannot currently make any intestinal allocation policy 
enforceable. If intestines are added as covered organs under the final 
rule as proposed here, the Secretary could take appropriate enforcement 
actions against a transplant hospital for failing to comply with the 
OPTN's intestinal allocation policy if such a policy has been approved 
as enforceable by the Secretary under the process outlined above. This 
enforcement authority is particularly significant given that many 
recipients of transplanted intestines receive such organs together with 
other organs covered under the final rule. It is necessary to ensure 
that intestinal organ allocation, whether pertaining to isolated 
intestinal transplants or combined/multi-organ transplants, is 
consistent with the goal of an equitable national system for organ 
allocation, as described in the final rule. Enforcing allocation for 
organs currently covered under the final rule, such as livers, would be 
difficult in instances in which intestines are transplanted together 
with such organs if intestinal allocation is not subject to the 
Secretary's enforcement authority.
    As the field of intestinal transplantation evolves, it will become 
more critical that intestinal organ allocation keeps pace with advances 
in the field; that policy development include performance indicators to 
assess whether the goals of an equitable transplant system are being 
achieved; that the Secretary has the authority to make those policies 
enforceable; and that patients and physicians have timely access to 
accurate data that will assist them in making decisions regarding 
intestinal transplantation. Upon consideration of the foregoing 
factors, and in order to achieve the most equitable and medically 
effective use of donated organs, the Secretary announces his conclusion 
that intestines should explicitly be added to the definition of organs 
covered by the final rule.

Public Participation

    Additional information on the submission of comments and/or the 
rulemaking process can be obtained from the Director, Division of 
Policy Review and Coordination, Health Resources and Services 
Administration (HRSA), 5600 Fishers Lane, Room 14A-11, Rockville, 
Maryland 20857.

Soliciting Public Comment as to Whether Any Other Organs Should Be 
Covered by the Rules Governing the Operation of the OPTN

    The Secretary also invites public comment as to the advisability of 
including any other organ within the ambit of the final rule. In 
addition to intestines, there may be other organs not currently covered 
under the final rule that, as a result of factors such as medical 
advances, a growing demand for transplantation, and concerns about 
equitable allocation, should be considered for inclusion under the 
final rule.

Including Intestines Within the Definition of Human Organs Covered by 
Section 301 of NOTA

    The Secretary further proposes including intestines within the 
definition of human organs covered by section 301, as amended, of the 
National Organ Transplant Act (NOTA) (hereinafter section 301), which 
prohibits the purchase or sale of human organs for human 
transplantation. Specifically, section 301, as amended, provides as 
follows:

Prohibition of Organ Purchases

(a) Prohibition

    It shall be unlawful for any person to knowingly acquire, receive, 
or otherwise transfer any human organ for valuable consideration for 
use in human transplantation if the transfer affects interstate 
commerce.

(b) Penalties

    Any person who violates subsection (a) of this section shall be 
fined not more than $50,000 or imprisoned not more than five years, or 
both.

(c) Definitions

    For purposes of subsection (a) of this section:
    (1) The term ``human organ'' means the human (including fetal) 
kidney, liver, heart, lung, pancreas, bone marrow, cornea, eye, bone, 
and skin or any subpart thereof and any other human organ (or any 
subpart thereof, including that derived from a fetus) specified by the 
Secretary of Health and Human Services by regulation.
    (2) The term ``valuable consideration'' does not include the 
reasonable payments associated with the removal, transportation, 
implantation, processing, preservation, quality control, and storage of 
a human organ or the expenses of travel, housing, and lost wages 
incurred by the donor of a human organ in connection with the donation 
of the organ.
    (3) The term ``interstate commerce'' has the meaning prescribed for 
it by section 321(b) of Title 21.

42 U.S.C. 274e. When it originally enacted NOTA, Congress defined the 
term ``human organ,'' within the

[[Page 70767]]

meaning of this section as ``the human kidney, liver, heart, lung, 
pancreas, bone marrow, cornea, eye, bone, and skin and any other human 
organ specified by the Secretary of Health and Human Services by 
regulation.'' NOTA, Pub. L. 98-507, Title III, section 301, 98 Stat. 
2346-2347 (1984). This section was subsequently amended by Congress to 
include fetal organs, as well as subparts of the specified organs. Pub. 
L. 100-607, Title IV, section 407, 102 Stat. 3116 (1988).
    As set forth by statute, Congress authorized the Secretary to add 
additional organs to the definition of ``human organ'' covered by 
section 301 through rulemaking in order to include the transplantation 
of additional human organs within section 301's prohibition. Through 
this notice, the Secretary proposes to add intestines to the list of 
human organs covered by section 301. The Secretary proposes adding a 
new section to part 121 to effectuate this addition, which section 301 
authorizes the Secretary to make by rulemaking.

Economic and Regulatory Impact

    Executive Order 12866 directs agencies to assess all costs and 
benefits of available regulatory alternatives and, when rulemaking is 
necessary, to select regulatory approaches that provide the greatest 
net benefits (including potential economic, environmental, public 
health, safety, distributive and equity effects). In addition, under 
the Regulatory Flexibility Act, if a rule has a significant economic 
effect on a substantial number of small entities the Secretary must 
specifically consider the economic effect of a rule on small entities 
and analyze regulatory options that could lessen the impact of the 
rule.
    Executive Order 12866 requires that all regulations reflect 
consideration of alternatives, of costs, of benefits, of incentives, of 
equity, and of available information. Regulations must meet certain 
standards, such as avoiding an unnecessary burden. Regulations which 
are ``significant'' because of cost, adverse effects on the economy, 
inconsistency with other agency actions, effects on the budget, or 
novel legal or policy issues, require special analysis.
    The Secretary has determined that no resources are required to 
implement the requirements in this rule. Therefore, in accordance with 
the Regulatory Flexibility Act of 1980 (RFA), and the Small Business 
Regulatory Enforcement Act of 1996, which amended the RFA, the 
Secretary certifies that this rule will not have a significant impact 
on a substantial number of small entities. Since independent and 
hospital-based organ procurement organizations (OPOs) are not 
considered small rural hospitals, because OPOs generally service large 
geographical areas, a regulatory flexibility analysis under the RFA and 
a rural impact analysis under section 1102(b) of the Act are not 
required.
    The Secretary has also determined that this proposed rule does not 
meet the criteria for a major rule as defined by Executive Order 12866 
and would have no major effect on the economy or Federal expenditures. 
We have determined that the proposed rule is not a ``major rule'' 
within the meaning of the statute providing for Congressional Review of 
Agency Rulemaking, 5 U.S.C. 801. Similarly, it will not have effects on 
State, local, and tribal governments and on the private sector such as 
to require consultation under the Unfunded Mandates Reform Act of 1995.
    Nor on the basis of family well-being will the provisions of this 
rule affect the following family elements: Family safety, family 
stability, marital commitment; parental rights in the education, 
nurture and supervision of their children; family functioning, 
disposable income or poverty; or the behavior and personal 
responsibility of youth, as determined under section 654(c) of the 
Treasury and General Government Appropriations Act of 1999.
    As stated above, this proposed rule would modify the regulations 
governing the OPTN and section 301 of NOTA based on legal authority.

Impact of the New Rule

    This proposed rule would have the effect of including transplanted 
human intestines within the ambit of the regulations governing the 
operation of the OPTN, and would include transplanted human intestines 
within the prohibition set forth at section 301 of NOTA. If 
implemented, the proposals set forth in this rule would authorize the 
Secretary to take enforcement actions against entities violating OPTN 
policies pertaining to the transplantation of intestines once such 
policies are approved as enforceable by the Secretary. In addition, if 
this proposal is implemented, individuals violating section 301 of NOTA 
with respect to intestinal transplants would be subject to criminal 
penalties.

Paperwork Reduction Act of 1995

    The amendments proposed in this notice of proposed rulemaking will 
not impose any additional data collection requirements beyond those 
already imposed under the current final rule, which have been approved 
by the Office of Management and Budget (OMB No. 0915-0157). The 
currently approved data collection includes worksheets and burden for 
intestinal transplants.

List of Subjects in 42 CFR Part 121

    Health care, Hospitals, Organ transplantation, Reporting and 
recordkeeping requirements.

    Dated: March 1, 2005.
Elizabeth M. Duke,
Administrator, Health Resources and Services Administration.
    Approved: May 20, 2005.
Michael O. Leavitt,
Secretary.

    Editorial Note: This document was received at the Office of the 
Federal Register November 18, 2005.

    Accordingly, 42 CFR part 121 is proposed to be amended as set forth 
below:

PART 121--ORGAN PROCUREMENT AND TRANSPLANTATION NETWORK

    1. The authority citation for part 121 is revised to read as 
follows:

    Authority: Sections 215, 371-376 of the Public Health Service 
Act (42 U.S.C. 216, 273-274d); sections 1102, 1106, 1138 and 1871 of 
the Social Security Act (42 U.S.C. 1302, 1306, 1320b-8 and 1395hh); 
and section 301 of the National Organ Transplant Act, as amended (42 
U.S.C. 274e).

    2. Amend Sec.  121.1 as follows:
    a. Revise paragraph (a) by replacing the phrase ``this part apply'' 
with the phrase ``this part, with the exception of Sec.  121.13, 
apply.''
    b. Redesignate paragraph (b) as paragraph (c).
    c. Add a new paragraph (b).
    The revision reads as follows:


Sec.  121.1  Applicability.

* * * * *
    (b) The provisions of Sec.  121.13 apply to the prohibition set 
forth in section 301 of the National Organ Transplant Act, as amended.
* * * * *
    3. Revise the definition of ``organ'' in Sec.  121.2 to read as 
follows:


Sec.  121.2  Definitions.

* * * * *
    Organ means a human kidney, liver, heart, lung, pancreas, or 
intestine.
* * * * *
    4. Add a new Sec.  121.13 to read as follows:


Sec.  121.13  Definition of Human Organ Under section 301 of the 
National Organ Transplant Act, as amended.

    ``Human organ,'' as covered by section 301 of the National Organ 
Transplant

[[Page 70768]]

Act, as amended, means the human (including fetal) kidney, liver, 
heart, lung, pancreas, bone marrow, cornea, eye, bone, skin, and 
intestine (or any subpart thereof).

[FR Doc. 05-23149 Filed 11-22-05; 8:45 am]
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