[Federal Register Volume 66, Number 249 (Friday, December 28, 2001)]
[Rules and Regulations]
[Pages 67109-67111]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-31724]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

42 CFR Part 486

[CMS-3064-IFC]
RIN 0938-AK81


Medicare and Medicaid Programs; Emergency Recertification for 
Coverage for Organ Procurement Organizations (OPOs)

AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.

ACTION: Interim final rule with comment period.

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SUMMARY: This interim final rule with comment period recertifies the 
existing designated organ procurement organizations (OPOs) that meet, 
or have met, the standards for a qualified OPO within a 4 year period 
ending December 31, 2001 and have current agreements with the Secretary 
that are scheduled to terminate on July 31, 2002. Those agreements will 
be extended to July 31, 2006. The Organ Procurement Organization 
Certification Act of 2000 amended the Public Health Service Act to 
require CMS to increase the certification cycle for OPOs from 2 years 
to at least 4 years. We are issuing this interim final rule to 
establish a 4 year recertification cycle and to permit payments to 
continue to be made to all 59 OPOs after January 1, 2002.

DATES: Effective date: These regulations are effective on December 28, 
2001.
    Comment date: Comments will be considered if we receive them at the 
appropriate address, as provided below, no later than 5 p.m. on 
February 26, 2002.

ADDRESSES: In commenting, please refer to file code CMS-3064-IFC. 
Because of staff and resource limitations, we cannot accept comments by 
facsimile (FAX) transmission.
    Mail written comments (one original and three copies) to the 
following address ONLY:
    Centers for Medicare & Medicaid Services, Department of Health and 
Human Services, Attention: CMS-3064-IFC, P.O. Box 8010, Baltimore, MD 
21244-8010.
    Please allow sufficient time for mailed comments to be timely 
received in the event of delivery delays.
    If you prefer, you may deliver (by hand or courier) your written 
comments (one original and three copies) to one of the following 
addresses:
    Room 443-G, Hubert H. Humphrey Building, 200 Independence Avenue, 
SW., Washington, DC 20201, or
    Room C5-16-03, 7500 Security Boulevard, Baltimore, MD 21244-1850.
    Comments mailed to the addresses indicated as appropriate for hand 
or courier delivery may be delayed and could be considered late.
    For information on viewing public comments, see the beginning of 
the SUPPLEMENTARY INFORMATION section.

FOR FURTHER INFORMATION CONTACT: Jacqueline Morgan, (410) 786-4282.
    Marcia Newton (410) 786-5265.

SUPPLEMENTARY INFORMATION:
    Inspection of Public Comments: Comments received timely will be 
available for public inspection as they are received, generally 
beginning approximately 3 weeks after publication of a document, at the 
headquarters of the Centers for Medicare & Medicaid Services, 7500 
Security Boulevard, Baltimore, Maryland 21244, Monday through Friday of 
each week from 8:30 a.m. to 4 p.m. To schedule an appointment to view 
public comments, call telephone number (410) 786-9994.

I. Background

    Organ procurement organizations (OPOs) play a crucial role in 
ensuring that an immensely valuable but scarce resource-transplantable 
human organs-become available to seriously ill patients who are on 
waiting lists for organ transplant. OPOs are government contractors for 
the length of their contract cycle. They are responsible for 
identifying potential organ donors and for obtaining as many organs as 
possible from those donors. They are also responsible for ensuring that 
the organs they obtain are properly preserved and quickly delivered to 
a suitable recipient awaiting transplantation. OPO performance is 
therefore a critical element of the organ transplant program. An OPO 
that is efficient in procuring organs and delivering them to recipients 
will, quite literally, save more lives than an ineffective OPO. Among 
other things, Congress has directed the Secretary to establish 
performance standards for OPOs, to ensure that federal funds go 
primarily to the most efficient OPOs and to ensure that OPOs have an 
incentive to achieve higher performance.
    In order to be an OPO, an entity must be certified or recertified 
by CMS as meeting the Public Health Service Act requirements to be a 
qualified OPO and must meet performance standards specified by the 
Secretary. In addition, in order to receive payment under the Medicare 
and Medicaid programs for organ procurement costs, the entity must be 
designated or redesignated by CMS as the OPO for a defined geographic 
service area.
    There are 59 OPOs that have been certified by CMS and designated 
for specific geographic service areas. At the conclusion of the most 
recent performance data cycle (the cycle in which we analyzed OPO 
performance data generated during the period of January 1, 1998 through 
December 31, 1999), 56 of the 59 OPOs were found by CMS to have met the 
performance standards and agreements were made through July 31, 2002. 
After additional legislation was enacted in November 2000, those three 
OPOs that did not meet the performance standards were notified by CMS 
on November 17, 2000 that their agreements were extended through July 
31, 2002, based on section 1138(b)(1)(A) of the Social Security Act. 
Each of these three OPOs had been certified or recertified as meeting 
the performance standards for the previous 2 year performance period 
(January 1, 1996 through December 31, 1997.)
    We are promulgating these rules to increase the OPO recertification 
period from 2 years to 4 years, in order to be consistent with the 
period described in the new statute. We are also recertifying all 59 
OPOs and extending agreeements with these OPOs until July 31, 2006. We 
have chosen July 31, 2006 as the ending date of the agreement because 
our contracts with designated OPOs have historically ended on July 31.
    We will publish a separate notice of proposed rulemaking that, 
among other things, will set forth proposed outcome and process 
performance standards for OPOs based on empirical evidence, obtained 
through reasonable efforts, of organ donor potential and other related 
factors in each service area.

II. Provisions of the Interim Final Rule

    We are establishing a new Sec. 486.309, Recertification for the 
January 1, 2002 through December 31, 2005 period. This section 
specifies that OPOs that were certified by CMS in the past and 
currently have agreements with CMS are recertified. The current 
agreements will be extended through July 31, 2006.
    Additionally, we are amending Sec. 486.301 by adding a new 
paragraph (b)(4) to reflect this change in the scope of the subpart.

III. Response to Comments

    Because of the large number of items of correspondence we normally 
receive on Federal Register documents published for comment, we are not 
able to acknowledge or respond to them individually. We will consider 
all

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comments we receive by the date and time specified in the ``DATES'' 
section of this preamble, and, when we proceed with a subsequent 
document, we will respond to the comments in the preamble to that 
document.

IV. Waiver of Proposed Rulemaking and Delayed Effective Date

    We ordinarily publish a notice of proposed rulemaking in the 
Federal Register and invite public comment on the proposed rule. The 
notice of proposed rulemaking includes a reference to the legal 
authority under which the rule is proposed, and the terms and 
substances of the proposed rule or a description of the subjects and 
issues involved. This procedure can be waived, however, if an agency 
finds good cause that a notice-and-comment procedure is impracticable, 
unnecessary, or contrary to the public interest and incorporates a 
statement of the finding and its reasons in the rule issued (5 U.S.C. 
553(b)(3)(B)).
    Further, we generally provide for final rules to be effective no 
sooner than 30 days after the date of publication unless we find good 
cause under 5 U.S.C. 553(d)(3) to waive the delay. The purpose of the 
30-day waiting period between publication of an administrative agency 
final rule and its effective date is to give affected parties 
reasonable time to adjust their behavior before the final rule takes 
place. This 30-day delay can be waived for good cause.
    Section 701 of Pub. L. 106-505 was enacted on November 13, 2000. 
Section 701(b) included Congressional findings and section 701(c) 
amended 42 U.S.C. 273(b)(1) to state that a qualified organ procurement 
organization for which grants are made under 42 U.S.C 273(a) must meet 
the other requirements of 42 U.S.C. 273 and has been certified or 
recertified by the Secretary within the previous 4-year period as 
meeting the performance standards to be a qualified OPO, through a 
process that either granted certification or recertification within 
such 4-year period with such certification or recertification in effect 
as of January 1, 2001 and remaining in effect through the earlier of 
January 1, 2002 or the completion of recertification through 
regulations meeting the requirements of 42 U.S.C. 273(b)(1)(D)(ii) that 
are promulgated by the Secretary by not later than January 1, 2002. 
Congress then enacted section 219 of Pub. L. 106-554 on December 21, 
2000. Section 219(a)-(b) is identical to the language of section 
701(b)-(c) in Pub. L. 106-505.
    The statute requires CMS to recertify OPOs and to establish at 
least a 4-year recertification period by January 1, 2002. Otherwise, 
OPOs would not be certified and we would be unable to make payments to 
OPOs (or to hospitals on behalf of OPOs) after that date. As discussed 
later in this preamble, this would put the nation's organ procurement 
system in jeopardy.
    When the legislation was enacted, CMS had just been briefed 
(November 15, 2000) on results from the Association of Organ 
Procurement Organization's (AOPO's) model for estimating organ donation 
potential in hospitals. CMS was in the process of analyzing a similar 
model developed by the Partnership for Organ Donation and the Harvard 
School of Public Health, following the completion of a 1-year contract 
with Harvard to apply their model nationwide. CMS met with AOPO 
representatives and researchers from the AOPO Death Record Review (DRR) 
study twice in late January 2001 for further analysis of the AOPO study 
results and to discuss possible denominators for the numeric 
performance standards. AOPO's written recommendations for new 
performance standards were received in March and April 2001, and CMS 
staff continued discussions with AOPO through May 2001 to gain 
additional industry input. Analysis of the Harvard and AOPO models 
continued throughout this time.
    CMS concluded that the time needed to develop accurate new 
performance standards ``based on empirical evidence, obtained through 
reasonable efforts, of organ donor potential and other related 
factors'' precluded the possibility of completing all of the required 
rulemaking by the statutory timeframe. Therefore, the agency is 
publishing an interim final rule with comment that recertifies all 59 
OPOs. We are also extending our agreements with all 59 of the current 
OPOs until July 31, 2006, on the basis of our observations and 
experience with those OPOs.
    According to section 371(b) of the Public Health Service Act, an 
OPO must be a ``qualified'' OPO, as determined by the Secretary. 
According to section 1138 of the Social Security Act, an OPO must be 
certified or recertified by the Secretary as meeting the standards to 
be a qualified OPO, must meet performance-related standards prescribed 
by the Secretary, and must be designated by the Secretary as an OPO in 
order to receive reimbursement under title XVIII or title XIX. Because 
section 273(b)(1)(D)(i) would terminate certifications after January 1, 
2002, we are issuing this interim final rule to permit all 59 OPOs to 
continue to function, procure organs and obtain appropriate 
reimbursement.
    The nation's 59 OPOs are responsible for all cadaveric organ 
recovery in the United States; without OPOs, cadaveric organs will not 
be recovered. Without recovery of cadaveric organs, very few organ 
transplants will take place. That is, only organs from living donors 
would be recovered and transplanted.
    As of October 31, 2001, there were 78,518 men, women, and children 
waiting for an organ transplant. Many of them will die waiting. In 
fact, every day, more than 15 patients die waiting for an organ. In 
2000, there were 17,255 transplants of organs from cadaveric donors, or 
nearly 47 transplants per day from cadaveric donors. This means that 
even a 1-day disruption in the nation's organ procurement system could 
result in the deaths of 47 patients waiting for organs. A 1-week 
disruption to the nation's organ procurement system could result in the 
deaths of 329 patients waiting for organs, and a 1-month disruption 
could result in 1,410 deaths.
    Clearly, it is critical that OPOs be recertified by January 1, 2002 
in order to continue this work. It would be contrary to the public 
interest to delay recertifying OPOs until after new outcome and process 
performance standards were established through notice and comment 
procedures. Moreover, because OPOs that are currently experienced in 
providing these services will continue to do so on January 1, 2002, 
they will not require additional time to prepare to implement these 
rules. Thus, there is good cause to waive the 30-day delay in effective 
date established by 5 U.S.C. 553(d). Therefore, we have chosen to 
publish a final rule with comment recertifying all 59 existing OPOs and 
establishing a 4-year recertification cycle. Publication as an 
immediately effective final rule will avert the impending problem that 
would occur under section 273(b)(1)(D)(i) after January 1, 2002.
    Therefore, we find good cause to waive the notice of proposed 
rulemaking and to issue this final rule on an interim basis. We are 
providing a 60-day public comment period.

V. Collection of Information Requirements

    This document does not impose information collection and 
recordkeeping requirements. Consequently, it need not be reviewed by 
the Office of Management and Budget under the authority of the 
Paperwork Reduction Act of 1995.

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VI. Regulatory Impact Statement

A. Overall Impact

    We have examined the impacts of this rule as required by Executive 
Order 12866 (September 1993, Regulatory Planning and Review) and the 
Regulatory Flexibility Act (RFA) (September 19, 1980 Pub. L. 96-354). 
Executive Order 12866 directs agencies to assess all costs and benefits 
of available regulatory alternatives and, if regulation is necessary, 
to select regulatory approaches that maximize net benefits (including 
potential economic, environmental, public health and safety effects, 
distributive impacts, and equity). A regulatory impact analysis (RIA) 
must be prepared for major rules with economically significant effects 
($100 million or more annually). This interim final rule is not a major 
rule. It does not have any cost or savings impact as it merely 
recertifies the existing 59 OPOs and does not introduce any new 
requirements.
    The RFA requires agencies to analyze options for regulatory relief 
of small businesses. For purposes of the RFA, small entities include 
small businesses, nonprofit organizations and government agencies. Most 
hospitals and most other providers and suppliers are small entities, 
either by nonprofit status or by having revenues of $25 million or less 
annually. For purposes of the RFA, all OPOs are considered to be small 
entities. Individuals and States are not included in the definition of 
a small entity.
    In addition, section 1102(b) of the Act requires us to prepare a 
regulatory impact analysis if a rule may have a significant impact on 
the operations of a substantial number of small rural hospitals. This 
analysis must conform to the provisions of section 603 of the RFA. For 
purposes of section 1102(b) of the Act, we define a small rural 
hospital as a hospital that is located outside of a Metropolitan 
Statistical Area and has fewer than 100 beds.
    Section 202 of the Unfunded Mandates Reform Act of 1995 also 
requires that agencies assess anticipated costs and benefits before 
issuing any rule that may result in expenditure in anyone year by 
State, local, or tribal governments, in the aggregate, or by the 
private sector, of $110 million. This rule will not have an effect on 
the governments mentioned, nor does it have associated private sector 
costs. This rule does not have any cost or savings impact as it extends 
the time period for payments under existing agreements and does not 
introduce any new requirements.
    According to section 1138 of the Social Security Act, an OPO must 
be certified or recertified by the Secretary as meeting the standards 
to be a qualified OPO, must meet performance-related standards 
prescribed by the Secretary, and must be designated by the Secretary as 
an OPO in order to receive reimbursement under title XVIII or title 
XIX. Because section 273(b)(1)(D)(i) would terminate certifications 
after January 1, 2002, we are issuing this interim final rule to permit 
all 59 OPOs to continue to function, procure organs and obtain 
appropriate reimbursement.
    Executive Order 13132 establishes certain requirements that an 
agency must meet when it promulgates a proposed rule (and subsequent 
final rule) that imposes substantial direct requirement costs on State 
and local governments, preempts State law, or otherwise has Federalism 
implications. As stated previously, this rule does not have a 
substantial effect on State or local governments.

B. Conclusion

    For these reasons, we are not preparing analyses for either the RFA 
or section 1102(b) of the Act because we have determined, and we 
certify, that this rule will not have a significant economic impact on 
a substantial number of small entities or a significant impact on the 
operations of a substantial number of small rural hospitals.
    In accordance with the provisions of Executive Order 12866, this 
regulation was reviewed by the Office of Management and Budget.

List of Subjects in 42 CFR Part 486

    Health professionals, Medicare, Organ procurement, X-rays.

PART 486--CONDITIONS OF COVERAGE OF SPECIALIZED SERVICES FURNISHED 
BY SUPPLIERS

    For the reasons set forth in the preamble, the Centers for Medicare 
& Medicaid Services is amending 42 CFR chapter IV as set forth below:
    1. The authority citation for part 486 continues to read as 
follows:

    Authority: Sections 1102 and 1871 of the Social Security Act (42 
U.S.C. 1302 and 1395hh).

Subpart G--Conditions of Coverage: Organ Procurement Organizations

    2. Section 486.301 is amended by adding paragraph (b)(4) to read as 
follows:


Sec. 486.301  Basis and scope.

* * * * *
    (b) * * *
    (4) The requirements for an OPO to be recertified for the 
performance data cycle from January 1, 2002 through December 31, 2005.
    3. Section 486.309 is added to read as follows:


Sec. 486.309  Recertification from January 1, 2002 through December 31, 
2005.

    An OPO will be considered to be recertified for the period of 
January 1, 2002 through December 31, 2005 if an entity meets, or has 
met, the standards to be a qualified OPO within a four year period 
ending December 31, 2001 and has an agreement with the Secretary that 
was scheduled to terminate on July 31, 2002. Agreements based on this 
recertification will end on July 31, 2006.

    (Catalog of Federal Domestic Assistance Program No. 93.778, 
Medical Assistance Program)

    (Catalog of Federal Domestic Assistance Program No. 93.773, 
Medicare--Hospital Insurance; and Program No. 93.774, Medicare--
Supplementary Medical Insurance Program)

    Dated: December 7, 2001.
Thomas A. Scully,
Administrator, Centers for Medicare & Medicaid Services.
    Approved: December 14, 2001.
Tommy G. Thompson,
Secretary.
[FR Doc. 01-31724 Filed 12-21-01; 11:04 am]
BILLING CODE 4120-01-P