9562 Federal Register / Vol. 71, No. 37 / Friday, February 24, 2006 / Notices 

Dated: February 10, 2006. 

Mark B. McClellan, 

Administrator, Centers for Medicare & 

Medicaid Services. 

[FR Doc. 06–1648 Filed 2–23–06; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–1332–NC] 

Medicare and Medicaid Programs; 

Announcement of an Application From 

a Hospital Requesting a Waiver From 

Its Designated Organ Procurement 

Service Area 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Notice with comment period. 

SUMMARY: This notice announces a 

hospital’s request for a waiver from 

entering into an agreement with its 

designated organ procurement 

organization (OPO), in accordance with 

section 1138(a)(2) of the Social Security 

Act. This notice requests comments 

from OPOs and the general public for 

our consideration in determining 

whether we should grant the requested 

waiver. 

DATES: To be assured consideration, 

comments must be received at one of 

the addresses provided below, no later 

than 5 p.m. on April 25, 2006. 

ADDRESSES: In commenting, please refer 

to file code CMS–1332–NC. Because of 

staff and resource limitations, we cannot 

accept comments by facsimile (FAX) 

transmission. 

You may submit comments in one of 

four ways (no duplicates, please): 

1. Electronically. You may submit 

electronic comments on specific issues 

in this regulation to http:// 

www.cms.hhs.gov/eRulemaking. 

(Attachments should be in Microsoft 

Word, WordPerfect, or Excel; however, 

we prefer Microsoft Word.) 

2. By regular mail. You may mail 

written comments (one original and two 

copies) to the following address ONLY: 

Centers for Medicare & Medicaid 

Services, Department of Health and 

Human Services, Attention: CMS–1332–

NC, P.O. Box 8015, Baltimore, MD 

21244–8015. 

Please allow sufficient time for mailed 

comments to be received before the 

close of the comment period. 

3. By express or overnight mail. You 

may send written comments (one 

original and two copies) to the following 

address ONLY: Centers for Medicare & 

Medicaid Services, Department of 

Health and Human Services, Attention: 

CMS–1332–NC, Mail Stop C4–26–05, 

7500 Security Boulevard, Baltimore, MD 

21244–1850. 

4. By hand or courier. If you prefer, 

you may deliver (by hand or courier) 

your written comments (one original 

and two copies) before the close of the 

comment period to one of the following 

addresses. If you intend to deliver your 

comments to the Baltimore address, 

please call telephone number (410) 786–

9994 in advance to schedule your 

arrival with one of our staff members. 

Room 445–G, Hubert H. Humphrey 

Building, 200 Independence Avenue, 

SW., Washington, DC 20201; or 7500 

Security Boulevard, Baltimore, MD 

21244–1850. 

(Because access to the interior of the 

HHH Building is not readily available to 

persons without Federal Government 

identification, commenters are 

encouraged to leave their comments in 

the CMS drop slots located in the main 

lobby of the building. A stamp-in clock 

is available for persons wishing to retain 

a proof of filing by stamping in and 

retaining an extra copy of the comments 

being filed.) 

Comments mailed to the addresses 

indicated as appropriate for hand or 

courier delivery may be delayed and 

received after the comment period. 

For information on viewing public 

comments, see the beginning of the 

SUPPLEMENTARY INFORMATION section. 

FOR FURTHER INFORMATION CONTACT: 

Mark A. Horney, (410) 786–4554. 

SUPPLEMENTARY INFORMATION: 

Submitting Comments: We welcome 

comments from the public on all issues 

set forth in this notice to assist us in 

considering whether we should grant 

the requested waiver. You can assist us 

by referencing the file code CMS–1332–

NC and the specific ‘‘issue identifier’’

that precedes the section on which you 

choose to comment. 

Inspection of Public Comments: All 

comments received before the close of 

the comment period are available for 

viewing by the public, including any 

personally identifiable or confidential 

business information that is included in 

a comment. CMS posts all electronic 

comments received before the close of 

the comment period on its public Web 

site as soon as possible after they have 

been received. Hard copy 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, phone 1–800–

743–3951. 

I. Background 

Organ Procurement Organizations 

(OPOs) are not-for-profit organizations 

that recover human organs from 

potential donors in hospitals and 

distribute them to transplant centers 

throughout the country. Qualified OPOs 

are designated by the Centers for 

Medicare & Medicaid Services (CMS) to 

recover organs in CMS-defined 

exclusive geographic service areas, 

according to section 371(b)(1)(F) of the 

Public Health Service Act (42 U.S.C. 

273(b)(1)(F)) and our regulations at 42 

CFR 486.307. Once an OPO has been 

designated for an area, hospitals in that 

area that participate in Medicare and 

Medicaid are required to work with that 

OPO in providing organs for 

transplantation, according to section 

1138(a) of the Social Security Act (the 

Act), and our regulations at 42 CFR 

482.45. Section 1138(a)(1)(A)(iii) of the 

Act provides that a hospital must notify 

the designated OPO (for the service area 

in which it is located) of potential organ 

donors. Under section 1138(a)(1)(C) of 

the Act, every participating hospital 

must have an agreement with its 

designated OPO to identify potential 

donors only within its service area. 

However, section 1138(a)(2) of the Act 

provides that a hospital may obtain a 

waiver of the above requirements from 

the Secretary under certain specified 

conditions. A waiver allows the hospital 

to have an agreement with an OPO other 

than the one initially designated by 

CMS, if the hospital meets certain 

conditions specified in section 

1138(a)(2) of the Act. In addition, the 

Secretary may review additional criteria 

described in section 1138(a)(2)(B) of the 

Act to evaluate the hospital’s request for 

a waiver. 

Section 1138(a)(2)(A) of the Act states 

that in granting a waiver, the Secretary 

must determine that the waiver: (1) Is 

expected to increase organ donations; 

and (2) will ensure equitable treatment 

of patients referred for transplants 

within the service area served by the 

designated OPO and within the service 

area served by the OPO with which the 

hospital seeks to enter into an 

agreement under the waiver. In making 

a waiver determination, section 

1138(a)(2)(B) of the Act provides that 

the Secretary may consider, among 

other factors: (1) Cost-effectiveness; (2) 

improvements in quality; (3) whether 

there has been any change in a 

hospital’s designated OPO due to the 


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Federal Register / Vol. 71, No. 37 / Friday, February 24, 2006 / Notices 9563 

changes made in definitions for 

metropolitan statistical areas (MSAs); 

and (4) the length and continuity of a 

hospital’s relationship with an OPO 

other than the hospital’s designated 

OPO. Under section 1138(a)(2)(D) of the 

Act, the Secretary is required to publish 

a notice of any waiver application 

within 30 days of receiving the 

application, and to offer interested 

parties an opportunity to comment in 

writing, during the 60-day public 

comment period. 

The criteria that the Secretary uses to 

evaluate the waiver in these cases are 

the same as those described above under 

sections 1138(a)(2)(A) and (B) of the Act 

and have been incorporated into the 

regulations at 42 CFR 486.316(e) and (f). 

II. Waiver Request Procedures 

In October 1995, we issued a Program 

Memorandum (Transmittal No. A–95–

11) detailing the waiver process and 

discussing the information that 

hospitals must provide in requesting a 

waiver. We indicated that upon receipt 

of a waiver request, we would publish 

a Federal Register notice to solicit 

public comments, as required by section 

1138(a)(2)(D) of the Act. 

According to these requirements, we 

will review the request and comments 

received. During the review process, we 

may consult on an as-needed basis with 

the Public Health Service’s Division of 

Transplantation, the United Network for 

Organ Sharing, and our regional offices. 

If necessary, we may request additional 

clarifying information from the applying 

hospital or others. We will then make a 

final determination on the waiver 

request and notify the hospital, the 

designated OPO, and the requested 

OPO. 

III. Hospital Waiver Request 

As permitted by 42 CFR 486.316(e), 

Piedmont Healthcare Systems of Rock 

Hill, South Carolina has requested a 

waiver in order to enter into an 

agreement with an alternative, out-ofarea OPO. Piedmont Healthcare Systems 

is requesting a waiver to work with: 

LifePoint, 4200 Faber Place Drive, 

Charleston, SC 29105. 

Piedmont Healthcare System’s 

designated OPO is: LifeShare of the 

Carolinas, 5000–D Airport Center 

Parkway, Charlotte, NC 28208. 

Piedmont Healthcare Systems must 

continue to work with its designated 

OPO while we complete our review. 

IV. 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 (44 

U.S.C. 35). 

Section 486.316 sets forth the 

requirements for a Medicare or 

Medicaid participating hospital to 

request a waiver permitting the hospital 

to have an agreement with an OPO other 

than the OPO designated for the service 

area in which the hospital is located. 

The burden associated with those 

requirements is currently approved 

under OMB 0938–0688, and HCFA–R–

13, Conditions of Coverage for Organ 

Procurement Organizations, with an 

expiration date of February 28, 2007. 

V. Response to Comments 

Because of the large number of public 

comments we normally receive on 

Federal Register documents, we are not 

able to acknowledge or respond to them 

individually. We will consider all 

comments we receive by the date and 

time specified in the DATES section of 

this preamble. 

VI. Regulatory Impact Statement 

We have examined the impact of this 

notice as required by Executive Order 

12866 (September 1993, Regulatory 

Planning and Review), the Regulatory 

Flexibility Act (RFA) (September 19, 

1980, Pub. L. 96–354), section 1102(b) of 

the Social Security Act, the Unfunded 

Mandates Reform Act of 1995 (Pub. L. 

104–4), and Executive Order 13132. 

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 

in any 1 year). This notice does not 

reach the economic threshold and thus 

is not considered a major rule. 

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 small 

governmental jurisdictions. Most 

hospitals and most other providers and 

suppliers are small entities, either by 

nonprofit status or by having revenues 

of $6 million to $29 million in any 1 

year. Individuals and States are not 

included in the definition of a small 

entity. We are not preparing an analysis 

for the RFA because we have 

determined that this rule will not have 

a significant economic impact on a 

substantial number of small entities. 

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 Core-Based Statistical Area and 

Metropolitan Statistical Area and has 

fewer than 100 beds. We are not 

preparing an analysis for section 1102(b) 

of the Act because we have determined 

that this notice will not have a 

significant impact on the operations of 

a substantial number of small rural 

hospitals. 

Section 202 of the Unfunded 

Mandates Reform Act of 1995 also 

requires that agencies assess anticipated 

costs and benefits before issuing any 

rule whose mandates require spending 

in any 1 year of $100 million in 1995 

dollars, updated annually for inflation. 

That threshold level is currently 

approximately $120 million. This notice 

will have no consequential effect on 

State, local, or tribal governments or on 

the private sector. 

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. 

Since this notice does not impose any 

costs on State or local governments, the 

requirements of E.O. 13132 are not 

applicable. 

Authority: Section 1138 of the Social 

Security Act (42 U.S.C. 1320b–8). 

(Catalog of Federal Domestic Assistance 

Program No. 93.773, Medicare-Hospital 

Insurance; Program No. 93.774, MedicareSupplementary Medical Insurance, and 

Program No. 93.778, Medical Assistance 

Program) 

Dated: February 9, 2006. 

Mark B. McClellan, 

Administrator, Centers for Medicare & 

Medicaid Services. 

[FR Doc. 06–1646 Filed 2–23–06; 8:45 am] 

BILLING CODE 4120–01–P 


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