50372 Federal Register / Vol. 70, No. 165 / Friday, August 26, 2005 / Notices 

Authority: Section 1923(a)(2), (f), and (h) of 

the Social Security Act (42 U.S.C. 1396r–

4(a)(2), (f), and (h), and Pub. L. 105–33).

(Catalog of Federal Domestic Assistance 

Program No. 93.778, Medical Assistance 

Program)

Dated: May 6, 2005. 

Mark B. McClellan, 

Administrator, Centers for Medicare & 

Medicaid Services. 

Approved: May 20, 2005. 

Michael O. Leavitt, 

Secretary.

[FR Doc. 05–16997 Filed 8–25–05; 8:45 am] 

BILLING CODE 4120–01–P

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–1309–NC] 

Medicare and Medicaid Programs; 

Announcement of an Application From 

a Hospital Requesting Waiver for 

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 October 25, 2005.

ADDRESSES: In commenting, please refer 

to file code CMS–1309–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/regulations/

ecomments. (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–1309–

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–1309–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 with comment 

period to assist us in fully considering 

issues and developing policies. You can 

assist us by referencing the file code 

CMS–1309–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 

[If you choose to comment on issues in 

this section, please include the caption 

‘‘BACKGROUND’’ at the beginning of 

your comments.]

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 transplant, 

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 to identify 

potential donors only with its 

designated OPO. 

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 

Federal Register / Vol. 70, No. 165 / Friday, August 26, 2005 / Notices 50373

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 

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 period 

beginning on the publication date in the 

Federal Register. 

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 and the 

designated and requested OPOs. 

III. Hospital Waiver Request 

As permitted by 42 CFR 486.316(e), 

Rockford Health System of Rockford, 

Illinois has requested a waiver in order 

to enter into an agreement with an 

alternative, out-of-area OPO. Rockford 

Health System is requesting a waiver to 

work with: University of Wisconsin 

OPO, University of Wisconsin Hospital 

and Clinic, 600 Highland Avenue, 

Madison, Wisconsin 53792. Rockford 

Health System’s designated OPO is: Gift 

of Hope Organ and Tissue Donor 

Network, 660 North Industrial Drive, 

Elmhurst, Il 60126–1520. Rockford 

Health System must continue to work 

with its designated OPO until the 

completion of our review.

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: August 9, 2005. 

Mark B. McClellan, 

Administrator, Centers for Medicare & 

Medicaid Services.

[FR Doc. 05–16796 Filed 8–25–05; 8:45 am] 

BILLING CODE 4120–01–P

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–4106–PN] 

Medicare Program; Changes in 

Medicare Advantage Deeming 

Authority

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS.

ACTION: Proposed notice.

SUMMARY: This proposed notice 

announces that on September 26, 2005, 

we will begin to accept revisions from 

private accrediting organizations (AOs) 

who seek to modify their deeming 

authority.

EFFECTIVE DATE: This proposed notice is 

effective on September 26, 2005.

FOR FURTHER INFORMATION CONTACT:

Shaheen Halim, 410–786–0641.

SUPPLEMENTARY INFORMATION: 

I. Background 

Section 4001 of the Balanced Budget 

Act of 1997 (BBA) (Pub. L. 105–33), 

enacted on August 5, 1987, added 

section 1852(e)(4) to the Social Security 

Act (the Act), which gives us the 

authority to determine that a Medicare 

Advantage (MA) organization is deemed 

to be in compliance with certain 

Medicare requirements if the MA 

organization has been accredited (and is 

periodically reaccredited) by an 

accrediting organization that we have 

determined applies and enforces 

requirements at least as stringent as 

those the MA organization would be 

deemed to meet. Section 518 of the 

Balanced Budget Refinement Act of 

1999 (BBRA) (Pub. L. 106–113), enacted 

on November 29, 1999, amended section 

1852(e)(4) of the Act to expand the 

scope of deeming from two to six areas. 

Accrediting organizations may seek 

authority for any of the categories. The 

BBRA specified that we cannot require 

an accrediting entity to be able to certify 

plans for all the deeming categories. It 

also required us to determine, within 

210 days from the day the application 

is determined to be complete, the 

eligibility of the accrediting 

organizations to be granted deeming 

authority. Conditions and procedures 

for granting deeming authority to 

accrediting organizations are outlined in 

§ 422.157 and § 422.158 of title 42 of the 

Code of Federal Regulations. 

Since the start of the Medicare 

Deeming program, we have approved 

three organizations to be AOs. These 

consist of the National Committee for 

Quality Assurance, the Joint 

Commission on the Accreditation of 

Healthcare Organizations, and 

Accreditation Association for 

Ambulatory Health Care (AAAHC). 

Section 722 of the Medicare 

Prescription Drug, Improvement, and 

Modernization Act of 2003 (MMA) (Pub. 

L. 108–173) revised section 1852(e)(4) of 

the Act. When we published the final 

rule of the Medicare Advantage program 

on January 28, 2005 (70 FR 4588), we 

made further changes to several sections 

of the rules that apply to the AOs. These 

changes consisted of the addition of the 

Chronic Care Improvement Program 

requirements (§ 422.152), and the 

deletion of some requirements in the 

areas of access and quality improvement 

projects. (§ 422.112 and § 422.152). 

Furthermore, it added prescription drug 

program requirements to the deemable 

areas. These areas include: 

• Access to covered drugs, as 

provided under § 423.120 and § 423.124. 

• Drug utilization management 

programs, quality assurance measures 

and systems, and Medication Therapy 

Management Programs as provided 

under § 423.153. 

• Privacy, confidentiality, and 

accuracy of enrollee records, as 

provided under § 423.136. 

• A program to protect against fraud, 

waste and abuse, as described in 

§ 423.504(b)(4)(vi)(H). 

II. Provisions of the Proposed Notice 

This proposed notice announces that 

30 days after publication, we will begin 

to accept applications from national 

private AOs who seek to modify their 

deeming authority. The application will 

consist of a letter stating how the 

applicant will modify their