[Federal Register Volume 72, Number 46 (Friday, March 9, 2007)]
[Rules and Regulations]
[Pages 10616-10619]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-4267]


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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: Final rule.

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SUMMARY: This Final Rule sets forth the Secretary's decision to include 
intestines within the definition of organs covered by the regulations 
governing the operations of the Organ Procurement and Transplantation

[[Page 10617]]

Network. The Secretary under the authority granted by section 301 of 
the National Organ Transplant Act, as amended, further effects a 
corresponding change to the definition of human organs covered in the 
statute with this Final Rule.

DATES: This Final Rule is effective March 9, 2007.

FOR FURTHER INFORMATION CONTACT: 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.

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 Final Rule 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 Rule.
    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 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 
esophagus, 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 regulations. Under the final rule, 
the OPTN must submit proposed policies for review and approval by the 
Secretary according to the requirements of 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 42 CFR 121.10. 
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 42 CFR 121.10, 
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 under 42 U.S.C. 1320b-8(a)(1)(B). Because 
intestines currently are not included within the regulation's 
definition of organs, the Secretary cannot make any intestinal 
allocation policy enforceable. The inclusion of intestines as covered 
organs under this Final Rule will allow the Secretary to take 
appropriate enforcement actions against a transplant hospital that 
fails to comply with any OPTN intestinal allocation policy if such a 
policy is approved by the Secretary. This enforcement authority is 
particularly significant given that many recipients of transplanted 
intestines receive such organs together with other organs covered under 
the regulations. 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. Enforcing the 
allocation for organs currently covered under the regulations, such as 
livers, would be difficult when intestines are transplanted together 
with other such organs if an 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 has determined that 
intestines should explicitly be added to the definition of organs 
covered by the OPTN regulations at 42 CFR Part 121.

Public Participation

    The public was invited to respond to the Notice of Proposed 
Rulemaking (NPRM) which was published in the Federal Register on 
November 23, 2005 (70 FR 70765-70768). The NPRM provided for a 60-day 
comment period. We received a total of three comments from the public. 
All three comments were in support of adding intestines to the 
definition of organs covered by the rules governing the OPTN and 
encouraged coordination with the Centers for Medicare and Medicaid 
Services. Consequently, this Final Rule is the same as the proposed 
rule published on November 23, 2005.

[[Page 10618]]

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

    The Secretary invited public comment as to the advisability of 
including any other organ within the ambit of this final rule. The 
comments we received did not request the inclusion of any other organ 
under the OPTN regulations.

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

    The Secretary further invited public comment on 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.
    Originally as enacted section 301 of NOTA (Pub. L. 98-507) defined 
the term ``human organ'' 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, Public Law 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, by 
Public Law 100-607, section 407.
    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. Through this Final Rule, the Secretary adds 
intestines to the list of human organs covered by section 301. The 
Secretary adds a new section to 42 CFR Part 121 to effectuate this 
change.
    The comments we received supported adding intestines to the 
definition of organs covered under section 301 of NOTA and encouraged 
coordination with the Centers for Medicare and Medicaid Services 
regarding implementation of the respective but related authorities 
regarding organ procurement and transplantation.

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 Final 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 Final Rule does not 
meet the criteria for a major rule as defined by Executive Order 12866, 
as amended by Executive Order 13258, and would have no major effect on 
the economy or Federal expenditures. We have determined that the Final 
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 
Final 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 Final Rule will modify the regulations 
governing the OPTN and section 301 of NOTA based on legal authority.

Impact of the New Rule

    This Final Rule will have the effect of including human intestines 
within the ambit of the regulations governing the operation of the 
OPTN, and will include transplanted human intestines within the changes 
made at section 301 of NOTA. The changes made in this Rule will 
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, individuals violating section 301 of NOTA with respect to 
intestinal transplants will be subject to criminal penalties.

Paperwork Reduction Act of 1995

    The amendments proposed in this Rule will not impose any additional 
data collection requirements beyond those already imposed under the 
current regulations, 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 9, 2007.
Elizabeth M. Duke,
Administrator, Health Resources and Services Administration.

    Approved: November 27, 2006.
Michael O. Leavitt,
Secretary.

0
Accordingly, 42 CFR part 121 is amended as set forth below:

PART 121--ORGAN PROCUREMENT AND TRANSPLANTATION NETWORK

0
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).


0
2. Amend Sec.  121.1 as follows:
0
a. Amend paragraph (a) by removing the phrase ``this part apply'' and 
adding in its place the phrase ``this part, with the exception of Sec.  
121.13, apply.''

[[Page 10619]]

0
b. Redesignate paragraph (b) as paragraph (c).
0
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.
* * * * *


Sec.  121.2  [Amended]

0
3. Amend the definition of ``organ'' in Sec.  121.2 by removing the 
word ``or'' and by adding the phrase ``, or intestine (including the 
esophagus, stomach, small and/or large intestine, or any portion of the 
gastrointestinal tract)'' after the term ``pancreas.''

0
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 Act, as amended, means the human (including fetal) kidney, 
liver, heart, lung, pancreas, bone marrow, cornea, eye, bone, skin, and 
intestine, including the esophagus, stomach, small and/or large 
intestine, or any portion of the gastrointestinal tract.

 [FR Doc. E7-4267 Filed 3-8-07; 8:45 am]
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