Federal Register / Vol. 66, No. 249 / Friday, December 28, 2001 / Rules and Regulations 67109

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.

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 organsbecome 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 § 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

§ 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

67110 Federal Register / Vol. 66, No. 249 / Friday, December 28, 2001 / Rules and Regulations

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.

Federal Register / Vol. 66, No. 249 / Friday, December 28, 2001 / Rules and Regulations 67111

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 performancerelated 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:

§ 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:

§ 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

FEDERAL COMMUNICATIONS

COMMISSION

47 CFR Parts 1, 43, and 63

[DA 01–2825]

Removal of References to Sections in

the Commission’s Rules That No

Longer Exist

AGENCY: Federal Communications

Commission.

ACTION: Final rule.

SUMMARY: In this document the

Commission amends references to

sections that have been removed from

the Commission’s rules and amends a

section heading.

DATES: Effective December 28, 2001.

FOR FURTHER INFORMATION CONTACT:

Peggy Reitzel, Telecommunications

Division, International Bureau, at (202)

418–1499.

SUPPLEMENTARY INFORMATION: We have

removed references to sections in the