Federal Register / Vol. 77, No. 165 / Friday, August 24, 2012 / Notices 51539 

accordance with the requirements at 

SOM chapter five. 

• DNVHC revised its policies and 

procedures to clarify that they do not 

have authority to advise facilities 

regarding certification issues. Instead, 

DNVHC must contact the CMS Regional 

Office on facility specific certification 

issues for consultation and direction. 

B. Term of Approval 

Based on our review and observations 

described in section III. of this final 

notice, we have determined that 

DNVHC’s requirements for hospitals 

meet or exceed our requirements. 

Therefore, we approve DVNHC as a 

national accreditation organization for 

hospitals that request participation in 

the Medicare program, effective 

September 26, 2012, through September 

26, 2018. 

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 (44 

U.S.C. 35). 

Authority: Section 1865 of the Social 

Security Act (42 U.S.C. 1395bb). 

(Catalog of Federal Domestic Assistance 

Program No. 93.778, Medical Assistance 

Program; No. 93.773, Medicare—Hospital 

Insurance Program; and No. 93.774, 

Medicare—Supplementary Medical 

Insurance Program) 

Dated: August 9, 2012. 

Marilyn Tavenner, 

Acting Administrator, Centers for Medicare 

& Medicaid Services. 

[FR Doc. 2012–20199 Filed 8–23–12; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–1452–NC] 

Medicare and Medicaid Programs; 

Announcement of 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 with comment 

period announces a hospital’s request 

for a waiver from the requirement to 

have an agreement with its designated 

Organ Procurement Organization (OPO). 

The request was made in accordance 

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

Security Act (the Act). In addition, this 

notice requests comments from OPOs 

and the general public for our 

consideration in determining whether 

we should grant the requested waiver. 

DATES: Comment Date: To be assured 

consideration, comments must be 

received at one of the addresses 

provided below, no later than 5 p.m. on 

October 23, 2012. 

ADDRESSES: In commenting, please refer 

to file code CMS–1452–NC. Because of 

staff and resource limitations, we cannot 

accept comments by facsimile (FAX) 

transmission. 

You may submit comments in one of 

four ways (please choose only one of the 

ways listed): 

1. Electronically. You may submit 

electronic comments on this regulation 

to http://www.regulations.gov. Follow 

the ‘‘Submit a comment’’ instructions. 

2. By regular mail. You may mail 

written comments to the following 

address ONLY: 

Centers for Medicare & Medicaid 

Services, Department of Health and 

Human Services, Attention: CMS–1452– 

NC, P.O. Box 8010, Baltimore, MD 

21244–1850. 

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 to the 

following address ONLY: 

Centers for Medicare & Medicaid 

Services, Department of Health and 

Human Services, Attention: CMS–1452– 

NC, Mail Stop C4–26–05, 7500 Security 

Boulevard, Baltimore, MD 21244–1850. 

4. By hand or courier. Alternatively, 

you may deliver (by hand or courier) 

your written comments ONLY to the 

following addresses: 

a. For delivery in Washington, DC— 

Centers for Medicare & Medicaid 

Services, Department of Health and 

Human Services, Room 445–G, Hubert 

H. Humphrey Building, 200 

Independence Avenue SW., 

Washington, DC 20201. 

(Because access to the interior of the 

Hubert H. Humphrey 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.) 

b. For delivery in Baltimore, MD— 

Centers for Medicare & Medicaid 

Services, Department of Health and 

Human Services, 7500 Security 

Boulevard, Baltimore, MD 21244–1850. 

If you intend to deliver your 

comments to the Baltimore address, call 

telephone number (410) 786–9994 in 

advance to schedule your arrival with 

one of our staff members. 

Comments erroneously 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: 

Patricia Taft, (410) 786–4561. 

SUPPLEMENTARY INFORMATION: 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. We post all comments 

received before the close of the 

comment period on the following Web 

site as soon as possible after they have 

been received: http:// 

www.regulations.gov. Follow the search 

instructions on that Web site to view 

public comments. 

Comments received timely will also 

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 are responsible for the 

procurement, preservation, and 

transport of organs to transplant centers 

throughout the country. Qualified OPOs 

are designated by the Centers for 

Medicare & Medicaid Services (CMS) to 

recover or procure organs in CMSdefined exclusive geographic service 

areas, pursuant to section 371(b)(1) of 

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

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

486.306. 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, 

pursuant to section 1138(a)(1)(C) 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 


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51540 Federal Register / Vol. 77, No. 165 / Friday, August 24, 2012 / Notices 

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 only with its 

designated OPO to identify potential 

donors. 

However, section 1138(a)(2)(A) 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)(A) 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 

changes made in definitions for 

metropolitan statistical areas; 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 received from 

a hospital within 30 days of receiving 

the application, and to offer interested 

parties an opportunity to submit 

comments during the 60-day comment 

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 § 486.308(e) and (f). 

II. Waiver Request Procedures 

On October 1995, we issued a 

Program Memorandum (Transmittal No. 

A–95–11) detailing the waiver process 

and discussing the information 

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 comments received. 

During the review process, we may 

consult on an as-needed basis with the 

Health Resources and Services 

Administration’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 486.308(e), 

the following hospital has requested a 

waiver in order to enter into an 

agreement with a designated OPO other 

than the OPO designated for the service 

area in which the hospital is located: 

Tri-Lakes Medical Center in 

Batesville, Mississippi, is requesting a 

waiver to work with: Mississippi Organ 

Recovery Agency, 12 River Bend Pl., 

Flowood, MS 39232. 

The Hospital’s Designated OPO is: 

Mid-South Transplant Foundation, Inc., 

8001 Centerview Parkway, Suite 302, 

Memphis, TN 38018. 

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). 

IV. 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, and, when we proceed 

with a subsequent document, we will 

respond to the comments in the 

preamble to that document. 

(Catalog of Federal Domestic Assistance 

Program No. 93.773, Medicare—Hospital 

Insurance; Program No. 93.774, Medicare— 

Supplementary Medical Insurance, and 

Program No. 93.778, Medical Assistance 

Program) 

Dated: August 20, 2012. 

Marilyn Tavenner, 

Acting Administrator, Centers for Medicare 

& Medicaid Services. 

[FR Doc. 2012–20920 Filed 8–23–12; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–4166–FN] 

Medicare Program; Approved Renewal 

of Deeming Authority of the 

Accreditation Association for 

Ambulatory Health Care, Inc. for 

Medicare Advantage Health 

Maintenance Organizations and Local 

Preferred Provider Organizations 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Final notice. 

SUMMARY: This notice announces our 

decision to renew the Medicare 

Advantage ‘‘deeming authority’’ of the 

Accreditation Association for 

Ambulatory Health Care, Inc. (AAAHC) 

for Health Maintenance Organizations 

and Preferred Provider Organizations for 

a term of 6 years. 

DATES: This final notice is effective 

through July 10, 2018. 

FOR FURTHER INFORMATION CONTACT: 

Abraham Weinschneider, (410) 786– 

5688; or Edgar Gallardo, (410) 786– 

0361. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Under the Medicare program, eligible 

beneficiaries may receive covered 

services through a Medicare Advantage 

(MA) organization that contracts with 

CMS. The regulations specifying the 

Medicare requirements that must be met 

for a Medicare Advantage Organization 

(MAO) to enter into a contract with 

CMS are located at 42 CFR part 422. 

These regulations implement Part C of 

Title XVIII of the Social Security Act 

(the Act), which specifies the services 

that an MAO must provide and the 

requirements that the organization must 

meet to be an MA contractor. Other 

relevant sections of the Act are Parts A 

and B of Title XVIII and Part A of Title 

XI pertaining to the provision of 

services by Medicare-certified providers 

and suppliers. Generally, for an entity to 

be an MA organization, the organization 

must be licensed by the State as a riskbearing organization as set forth in part 

422. 

As a method of assuring compliance 

with certain Medicare requirements, an 

MA organization may choose to become 

accredited by a CMS-approved 

accrediting organization (AO). Once 

accredited by such a CMS-approved AO, 

we deem the MA organization to be 

compliant in one or more of six 


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