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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Federal Register / Vol. 77, No. 165 / Friday, August 24, 2012 / Notices 51541 

requirements set forth in section 

1852(e)(4)(B) of the Act. For an AO to 

be able to ‘‘deem’’ an MA plan 

compliant with these MA requirements, 

the AO must prove to CMS that its 

standards are at least as stringent as 

Medicare requirements. Health 

maintenance organizations (HMOs) or 

preferred provider organizations (PPOs) 

accredited by an approved AO may 

receive, at their request, ‘‘deemed’’ 

status for CMS requirements with 

respect to the following six MA criteria: 

Quality Improvement; 

Antidiscrimination; Access to Services; 

Confidentiality and Accuracy of 

Enrollee Records; Information on 

Advanced Directives; and Provider 

Participation Rules. (See 42 CFR 

422.156(b)). At this time, recognition of 

accreditation does not include the Part 

D areas of review set out at § 423.165(b). 

AOs that apply for MA deeming 

authority are generally recognized by 

the health care industry as entities that 

accredit HMOs and PPOs. As we specify 

at § 422.157(b)(2)(ii), the term for which 

an AO may be approved by CMS may 

not exceed 6 years. For continuing 

approval, the AO must apply to CMS to 

renew its ‘‘deeming authority’’ for a 

subsequent approval period. 

The Accreditation Association for 

Ambulatory Health Care, Inc. (AAAHC) 

was approved by CMS as an 

accreditation organization for MA 

HMOs and PPOs on July 12, 2006, and 

that term will expire on July 11, 2012. 

On December 14, 2011, AAAHC 

submitted an application to renew its 

deeming authority. On that same date, 

AAAHC submitted materials requested 

from CMS which included updates and/ 

or changes to items set out in Federal 

regulations at § 422.158(a) that are 

prerequisites for receiving approval of 

its accreditation program from CMS, 

and which were furnished to CMS by 

AAAHC as a part of their renewal 

applications for HMOs and PPOs. 

II. Deeming Applications Approval 

Process 

Section 1865(a)(3)(A) of the Act 

provides a statutory timetable to ensure 

that our review of deeming applications 

is conducted in a timely manner. The 

Act provides us with 210 calendar days 

after the date of receipt of an application 

to complete our survey activities and 

application review process. Within 60 

days of receiving a completed 

application, we must publish a notice in 

the Federal Register that identifies the 

national accreditation body making the 

request, describes the request, and 

provides no less than a 30-day public 

comment period. At the end of the 210- 

day period, we must publish an 

approval or denial of the application. 

III. Proposed Notice 

In the March 30, 2012, Federal 

Register (76 FR 19290), we published a 

proposed notice announcing AAAHC’s 

request for continued CMS approval of 

its deeming authority for MA HMOs and 

PPOs. In the proposed notice, we 

detailed our evaluation criteria. Under 

section 1852(e)(4) of the Act and our 

regulations at § 422.158 (Federal review 

of accrediting organizations), we 

conducted a review of AAAHC’s 

application in accordance with the 

criteria specified by our regulations, 

which include, but are not limited to the 

following: 

• The types of MA plans that it would 

review as part of its accreditation 

process. 

• A detailed comparison of the 

organization’s accreditation 

requirements and standards with the 

Medicare requirements (for example, a 

crosswalk). 

• Detailed information about the 

organization’s survey process, including 

the following— 

++ Frequency of surveys and whether 

surveys are announced or unannounced. 

++ Copies of survey forms, and 

guidelines and instructions to 

surveyors. 

++ Descriptions of— 

—The survey review process and the 

accreditation status decision making 

process; 

—The procedures used to notify 

accredited MA organizations of 

deficiencies and to monitor the 

correction of those deficiencies; and 

—The procedures used to enforce 

compliance with accreditation 

requirements. 

• Detailed information about the 

individuals who perform surveys for the 

accreditation organization, including 

the following— 

++ The size and composition of 

accreditation survey teams for each type 

of plan reviewed as part of the 

accreditation process; 

++ The education and experience 

requirements surveyors must meet; 

++ The content and frequency of the 

in-service training provided to survey 

personnel; 

++ The evaluation systems used to 

monitor the performance of individual 

surveyors and survey teams; and 

++ The organization’s policies and 

practice with respect to the 

participation, in surveys or in the 

accreditation decision process by an 

individual who is professionally or 

financially affiliated with the entity 

being surveyed. 

• A description of the organization’s 

data management and analysis system 

with respect to its surveys and 

accreditation decisions, including the 

kinds of reports, tables, and other 

displays generated by that system. 

• A description of the organization’s 

procedures for responding to and 

investigating complaints against 

accredited organizations, including 

policies and procedures regarding 

coordination of these activities with 

appropriate licensing bodies and 

ombudsmen programs. 

• A description of the organization’s 

policies and procedures with respect to 

the withholding or removal of 

accreditation for failure to meet the 

accreditation organization’s standards or 

requirements, and other actions the 

organization takes in response to 

noncompliance with its standards and 

requirements. 

• A description of all types (for 

example, full, partial) and categories (for 

example, provisional, conditional, 

temporary) of accreditation offered by 

the organization, the duration of each 

type and category of accreditation and a 

statement identifying the types and 

categories that would serve as a basis for 

accreditation if CMS approves the 

accreditation organization. 

• A list of all currently accredited MA 

organizations and the type, category, 

and expiration date of the accreditation 

held by each of them. 

• A list of all full and partial 

accreditation surveys scheduled to be 

performed by the accreditation 

organization as requested by CMS. 

• The name and address of each 

person with an ownership or control 

interest in the accreditation 

organization. 

• CMS also considers AAAHC’s past 

performance in the deeming program 

and results of recent deeming validation 

reviews, or look-behind audits 

conducted as part of continuing Federal 

oversight of the deeming program under 

§ 422.157(d). 

In accordance with section 

1865(a)(3)(A) of the Act, the March 30, 

2012 proposed notice (76 FR 19290) also 

solicited public comments regarding 

whether AAAHC’s requirements met or 

exceeded the Medicare conditions of 

participation as an accrediting 

organization for MA HMOs and PPOs. 

We received no public comments in 

response to our proposed notice. 


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51542 Federal Register / Vol. 77, No. 165 / Friday, August 24, 2012 / Notices 

IV. Provisions of the Final Notice 

A. Differences Between AAAHC’s 

Standards and Requirements for 

Accreditation and Medicare’s 

Conditions and Survey Requirements 

We compared the standards and 

survey process contained in AAAHC’s 

application with the Medicare 

conditions for accreditation. Our review 

and evaluation of AAAHC’s application 

for continued CMS-approval were 

conducted as described in section III of 

this final notice, and yielded the 

following: 

• To meet the requirements at 

§ 488.10(b), AAAHC modified its 

policies to include ‘‘person(s) receiving 

hospice benefits prior to completing an 

enrollment request for an MSA plan’’ as 

an exception where an MAO may deny 

enrollment based on medical status. 

• AAAHC amended its crosswalk to 

ensure current AAAHC standards are 

clearly crosswalked to the following 

regulatory requirements: 

§§ 422.112(a)(7); 422.118(d); 

422.202(d)(1); and 422.204(b)(2). 

• To meet the amendments made at 

§ 422.156 by the final rule published in 

the April 15, 2011 Federal Register (76 

CFR 21498), AAAHC removed Quality 

Improvement Projects and Chronic Care 

Improvement Programs from its 

deeming process. 

B. Term of Approval 

Based on the review and observations 

described in section III of this final 

notice, we have determined that 

AAAHC’s accreditation program 

requirements meet or exceed our 

requirements. Therefore, we approve 

AAAHC as a national accreditation 

organization with deeming authority for 

MA HMOs and PPOs, effective July 11, 

2012 through July 10, 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—Supplemental Medical Insurance 

Program). 

Dated: August 9, 2012. 

Marilyn Tavenner, 

Acting Administrator, Centers for Medicare 

& Medicaid Services. 

[FR Doc. 2012–20195 Filed 8–23–12; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–1596–N] 

Medicare Program; Solicitation of Two 

Nominations to the Advisory Panel on 

Hospital Outpatient Payment 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Notice. 

SUMMARY: This notice solicits 

nominations for two new members to 

the Advisory Panel on Hospital 

Outpatient Payment (HOP, the Panel). 

There will be two vacancies on the 

Panel beginning September 30, 2012. 

The purpose of the Panel is to advise 

the Secretary of the Department of 

Health and Human Services (DHHS) 

(the Secretary) and the Administrator of 

the Centers for Medicare & Medicaid 

Services (CMS) (the Administrator) on 

the clinical integrity of the Ambulatory 

Payment Classification (APC) groups 

and their associated weights, and 

supervision of hospital outpatient 

services. 

The Secretary rechartered the Panel in 

2011 for a 2-year period effective 

through November 15, 2013. 

DATES: Submission of Nominations: We 

will consider nominations if they are 

received no later than 5 p.m. (e.s.t.) 

October 23, 2012. 

ADDRESSES: Please mail or hand deliver 

nominations to the following address: 

Centers for Medicare & Medicaid 

Services; Attn: Raymond Bulls, 

Advisory Panel on HOP; Center for 

Medicare, Hospital & Ambulatory Policy 

Group, Division of Outpatient Care; 

7500 Security Boulevard, Mail Stop C4– 

05–17; Baltimore, MD 21244–1850. 

Web site: For additional information 

on the Panel and updates to the Panel’s 

activities, we refer readers to our Web 

site at the following: http://

www.cms.gov/RegulationsandGuidance/Guidance/FACA/

AdvisoryPanelonAmbulatoryPayment

ClassificationGroups.html. 

FOR FURTHER INFORMATION CONTACT: 

Contact: Persons wishing to nominate 

individuals to serve on the Panel or to 

obtain further information may also 

contact Raymond Bulls at the following 

email address: APCPanel@cms.hhs.gov 

or call 410–786–7267. 

Advisory Committees’ Information 

Lines: You may also refer to the CMS 

Federal Advisory Committee Hotlines at 

1–877–449–5659 (toll-free) or 410–786– 

3985 (local) for additional information. 

News Media: Representatives should 

contact the CMS Press Office at 202– 

690–6145. 

SUPPLEMENTARY INFORMATION: 

I. Background 

The Secretary is required by section 

1833(t)(9)(A) of the Social Security Act 

(the Act), and section 222 of the Public 

Health Service Act (PHS Act) to consult 

with an expert outside advisory panel 

regarding the clinical integrity of the 

APC groups and relative payment 

weights that are components of the 

Medicare Hospital Outpatient 

Prospective Payment System (OPPS), 

and the appropriate supervision level 

for hospital outpatient services. The 

panel may use data collected or 

developed by entities and organizations 

(other than DHHS) in conducting the 

review. The Panel is governed by the 

provisions of the Federal Advisory 

Committee Act (FACA) (Public Law 92– 

463), as amended (5 U.S.C. Appendix 2), 

which sets forth standards for the 

formation and use of advisory panels. 

The Charter requires that the Panel 

meet up to three times annually. CMS 

considers the technical advice provided 

by the Panel as we prepare the proposed 

and final rules to update the OPPS for 

the following calendar year. 

The Panel shall consist of a chair and 

up to 19 members who are full-time 

employees of hospitals, hospital 

systems, or other Medicare providers 

that are subject to the OPPS. (For 

purposes of the Panel, consultants or 

independent contractors are not 

considered to be full-time employees in 

these organizations.) 

The current Panel members are as 

follows: (Note: The asterisk [*] indicates 

the Panel members whose terms end on 

September 30, 2012.) 

• E. L. Hambrick, M.D., J.D., Chair, a 

CMS Medical Officer 

• Karen Borman, M.D. 

• Ruth L. Bush, M.D., M.P.H. 

• Lanny Copeland, M.D. 

• Kari S. Cornicelli, C.P.A., FHFMA 

• Dawn L. Francis, M.D., M.H.S. 

• David A. Halsey, M.D. 

• Brain D. Kavanagh, M.D., M.P.H. 

• Judith T. Kelly, B.S.H.A., RHIT, RHIA, 

CCS* 

• Scott Manaker, M.D., Ph.D. 

• John Marshall, CRA, RCC, RT 

• Jim Nelson 


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