Medicare and Medicaid Programs; Reapproval of Deeming Authority of the Accreditation Association for Ambulatory Health Care, Inc. for Medicare Advantage Health Maintenance Organizations and Local Preferred Provider Organizations, 3854-3856 [E7-1274]

Download as PDF 3854 Federal Register / Vol. 72, No. 17 / Friday, January 26, 2007 / Notices advised the Secretary of the Department of Health and Human Services (DHHS) and the Administrator of the Centers for Medicare and Medicaid Services (CMS), as requested by the Secretary, whether medical items and services were reasonable and necessary under Title XVIII of the Social Security Act (the Act). The MCAC consisted of a pool of 100 appointed members. Members were selected from among authorities in clinical medicine of all specialties, administrative medicine, public health, biologic and physical sciences, health care data and information management and analysis, patient advocacy, the economics of health care, medical ethics, and other related professions such as epidemiology and biostatistics, and methodology of trial design. A maximum of 88 members are standard voting members, 12 are nonvoting members, 6 of whom are representatives of consumer interests, and 6 of whom are representatives of industry interests. II. Provisions of This Notice sroberts on PROD1PC70 with NOTICES A. Renewal of the Charter and the Renaming of the Committee This notice announces the signing of the MedCAC charter renewal by the Secretary on November 24, 2006. The charter will terminate on November 24, 2008, unless renewed by the Secretary. The new charter makes the following changes: • Redesignates the Committee from the MCAC to Medicare Evidence Development Coverage Advisory Committee. • Gives the MedCAC an explicit responsibility to advise CMS as part of its coverage with evidence development (CED) activity. The CED initiative involves the issuance of national coverage determinations that include, a condition of payment, requirements for developing additional clinical data on a particular medical technology. • Formalizes the role of patient advocates on the MedCAC role. By establishing the patient advocate as a permanent MedCAC role, CMS is ensuring that beneficiary community is represented on the panels. These advocates will identify issues most important to patients, communicate the patient perspective, and vote on the Committee’s recommendations with patients’ general interests in mind. To accompany the changes in the MedCAC charter, we have issued a guidance document entitled, ‘‘Factor CMS Considers in Referring Topics to the Medicare Evidence Development and Coverage Advisory Committee.’’ This document is consistent with VerDate Aug<31>2005 17:19 Jan 25, 2007 Jkt 211001 Section 731 of the Medicare Prescription Drug Improvement, and Modernization Act (MMA) of 2003, and is in line with our goal of continuing to develop a more open, transparent, and understandable national coverage process. B. Request for Nominations As of May 2007, there will be 28 terms of membership expiring, 2 of which are nonvoting consumer representatives, 1 of which is a nonvoting industry representative and 6 voting patient advocates. Accordingly, we are requesting nominations for both voting and nonvoting members to serve on the MedCAC. Members are invited to serve for overlapping 4 year terms. A member may serve after the expiration of the member’s term until a successor takes office. Any interested person may nominate one or more qualified persons. Self-nominations are also accepted. We have a special interest in ensuring that women, minority groups, and physically challenged individuals are adequately represented on the MedCAC. Therefore, we encourage nominations of qualified candidates from these groups. Nominees are selected based upon their individual qualifications and not as representatives of professional associations or societies. The MedCAC functions on a committee basis. The committee reviews and evaluates medical literature, reviews technology assessments, and examines data and information on the effectiveness and appropriateness of medical items and services that are covered or eligible for coverage under Medicare. The Committee works from an agenda provided by the designated Federal official that lists specific issues, and develops technical advice to assist us in determining reasonable and necessary applications of medical services and technology when we make national coverage decisions for Medicare. 1. Membership Criteria Nominees for voting membership must have expertise and experience in one or more of the following fields: clinical medicine of all specialties, administrative medicine, public health, patient advocacy, biologic and physical sciences, health care data and information management and analysis, the economics of health care, medical ethics, and other related professions such as epidemiology and biostatistics, and methodology of trial design. 2. Submission of Nominations All nominations must be accompanied by nomination letter and curricula vitae. Nomination packages PO 00000 Frm 00076 Fmt 4703 Sfmt 4703 must be sent to the address specified in the ADDRESSES section this notice. The nomination letter must include—(1) A statement that the nominee is willing to serve as a member of the MedCAC and believes that he or she does not have a conflict of interest that would preclude his or her committee membership; and (2) specify whether the nominee is applying for a voting position, consumer representative; industry representative or patient advocate. The curricula vitae must include the following: (1) Date of birth; (2) place of birth; (3) social security number; (4) title and current position; (5) professional affiliation; (6) home and business addresses; (7) telephone and fax numbers; (8) e-mail address; and (9) list of the nominee’s areas of expertise. Potential candidates will be asked to provide detailed information concerning such matters as financial holdings, consultancies, and research grants or contracts in order to permit evaluation of possible sources of conflict of interest. Authority: 5 U.S.C. App. 2, section 10(a)(1) and (a)(2). (Catalog of Federal Domestic Assistance Program No. 93.774, Medicare— Supplementary Medical Insurance Program) Dated: January 11, 2007. Barry M. Straube, Chief Medical Officer, Director, Office of Clinical Standards and Quality, Centers for Medicare &Medicaid Services. [FR Doc. E7–1113 Filed 1–25–07; 8:45 am] BILLING CODE 4120–03–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [CMS–4126–FN] Medicare and Medicaid Programs; Reapproval of Deeming Authority of the Accreditation Association for Ambulatory Health Care, Inc. for Medicare Advantage Health Maintenance Organizations and Local Preferred Provider Organizations Centers for Medicare & Medicaid Services (CMS), HHS. ACTION: Final notice. AGENCY: SUMMARY: This notice announces our decision to approve Medicare Advantage Deeming Authority of the Accreditation Association for Ambulatory Health Care, Inc. for health maintenance organizations and local preferred provider organizations for a term of 6 years. E:\FR\FM\26JAN1.SGM 26JAN1 Federal Register / Vol. 72, No. 17 / Friday, January 26, 2007 / Notices Effective Date: This final notice is effective July 12, 2006 through July 11, 2012. FOR FURTHER INFORMATION CONTACT: Shaheen Halim, (410) 786–0641. SUPPLEMENTARY INFORMATION: DATES: sroberts on PROD1PC70 with NOTICES I. Background Under the Medicare program, eligible beneficiaries may receive covered services through a managed care organization (MCO) that has a Medicare Advantage (MA) (formerly, Medicare+Choice) contract with the Centers for Medicare & Medicaid Services (CMS). The regulations specifying the Medicare requirements that must be met in order for an MCO to enter into an MA 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 MCO 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 MCO to be an MA organization, the MCO must be licensed by the State as a risk bearing organization as set forth in part 422 of our regulations. Additionally, the MCO must file an application demonstrating that it meets other Medicare requirements in part 422 of our regulations. Following approval of the MA contract, we engage in routine monitoring and oversight audits of the MA organization to ensure continuing compliance. The monitoring and oversight audit process is comprehensive and uses a written protocol that itemizes the Medicare requirements the MA organization must meet. As an alternative for meeting some Medicare requirements, an MA organization may be exempt from CMS monitoring of certain requirements as described in section 1852(e)(4)(B) of the Social Security Act (the Act) as a result of an MA organization’s accreditation by a CMS-approved accrediting organization (AO). In essence, the Secretary ‘‘deems’’ that the Medicare requirements are met based on a determination that the AO’s standards are at least as stringent as Medicare requirements. Therefore, MA organizations that are licensed as health maintenance organizations (HMOs) or preferred provider organizations (PPOs) and are accredited by an approved accrediting organization may receive, at their request, deemed status for the MA VerDate Aug<31>2005 17:19 Jan 25, 2007 Jkt 211001 requirements in the following six areas: Quality Improvement, Information on Advance Directives, Antidiscrimination, Confidentiality and Accuracy of Enrollee Records, Access to Services, and Provider Participation Rules. At this time, deeming does not include the Part D areas of review listed in § 422.156(b). Organizations that apply for MA deeming authority are generally recognized by the industry as entities that accredit MCOs that are licensed as an HMO or a PPO. As we specify at § 422.157(b)(2) of our regulations, the term for which an AO may be approved by CMS may not exceed 6 years. For continuing approval, the AO must reapply to CMS. Accreditation Association for Ambulatory Health Care, Inc. (AAAHC) was approved as an authorized AO for Medicare Advantage deeming on June 15, 2002. AAAHC was granted a term of approval of 4 years beginning June 15, 2002, and ending on June 14, 2006. On June 13, 2006, we issued a letter to AAAHC with instructions regarding application for a renewal of term. On June 14, 2006, AAAHC submitted a letter of intent to renew its MA deeming authority, and subsequently submitted all materials requested by CMS for a complete renewal application. The materials requested by CMS included updates and/or changes to items listed in Federal regulations at 42 CFR 422.158(a) that are prerequisites for receiving deeming program approval by CMS, and which were furnished to CMS by AAAHC as part of its initial application for deeming authority in 2002. II. Deeming Applications Approval Process Section 1852(e)(4)(C) 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. At the end of the 210-day period, we must publish an approval or denial of the application in the Federal Register. III. Proposed Notice On October 27, 2006, we published a proposed notice (71 FR 63019) announcing reapproval of Medicare Advantage Deeming Authority of the Accreditation Association for Ambulatory Health Care, Inc. In the proposed notice, we detailed our evaluation criteria. Under section 1852(e)(4) of the Act and our regulations at § 422.158, we conducted a review and evaluation of the AAAHC’s PO 00000 Frm 00077 Fmt 4703 Sfmt 4703 3855 accreditation program (including its standards and monitoring protocol) in accordance with the criteria specified by our regulation, which includes, but are not limited to the following: A. Components of the Review Process The review of AAAHC’s application for approval of MA deeming authority included the following components: 1. Desk-Top Review We conducted a desk-top review of updated materials regarding AAAHC’s managed care accreditation program, including— • A description of AAAHC’s survey process for managed care plans, including the frequency of surveys performed, whether the surveys are announced or unannounced, surveyor instructions, the review and accreditation status decision-making process, procedures used to notify accredited MA organizations of deficiencies and monitoring of the correction of deficiencies, and the procedures used to enforce compliance with accreditation requirements; • Information about the individuals who perform network accreditation reviews, including the size and composition of the survey team, the methods of compensation, the education and experience requirements, the content and frequency of the in-service training, the evaluation system used to monitor performance, and conflict of interest requirements governing AAAHC staff and surveyors; • A description of the data management and analysis system, the types (full, partial, or denial) and categories (provisional, conditional, temporary) of accreditation offered by AAAHC, the duration of each category of accreditation, and a statement identifying the types and categories that would serve as a basis for accreditation, if we grant AAAHC organization deeming authority; • The procedures used to respond to and investigate complaints or identify other problems with accredited organizations, including coordination of these activities with licensing bodies and ombudsmen programs; • A description of how AAAHC provides accreditation information to the general public; • The policies and procedures for (1) withholding, denying and removing accreditation status, and the other actions AAAHC may take in response to noncompliance with their standards and requirements, and (2) how AAAHC treats accreditation of organizations that are acquired by another organization, have merged with another organization, E:\FR\FM\26JAN1.SGM 26JAN1 3856 Federal Register / Vol. 72, No. 17 / Friday, January 26, 2007 / Notices or that undergo a change of ownership or management; • Lists of all AAAHC-accredited MA organizations, managed care plans surveyed by AAAHC in the past 3 years, and managed care plans that were scheduled to be surveyed by AAAHC within 3 months of submitting their application. 2. Assessment of AAAHC’s Standards and Methods of Evaluation As part of the application for renewal of term, AAAHC submitted a crosswalk that compared its standards and methods of evaluations with corresponding MA audit requirements in six areas: Quality Improvement, Access to Services, Antidiscrimination, Information on Advance Directives, Provider Participation Rules, and Confidentiality and Accuracy of Enrollee Records. 3. Past Performance and Results of Deeming Validation Review (Lookbehind Audit) We also considered 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). B. Results of the Review Process Using the information listed in section III.A. of this notice, we determined that AAAHC’s current accreditation program for managed care plans continues to be at least as stringent as the MA requirements contained in the six categories set forth in section 1852(e)(4)(C) of the Act and our methods of evaluation for those areas. sroberts on PROD1PC70 with NOTICES IV. Provisions of the Final Notice No comments were received in response to the proposed notice published October 27, 2006. Therefore, based on the review and observations described in section III of this final notice, we have determined that AAAHC’s requirements for HMOs and local PPOs continue to meet or exceed our requirements. We recognize AAAHC as a national accreditation organization for HMOs and PPOs that request participation in the Medicare program, and we approve AAAHC’s deeming program effective July 12, 2006 through July 11, 2012. V. Collection of Information Requirements This final notice does not impose any information collection and record keeping requirements subject to the VerDate Aug<31>2005 17:19 Jan 25, 2007 Jkt 211001 Paperwork Reduction Act (PRA). Consequently, it does not need to be reviewed by the Office of Management and Budget (OMB) under the authority of the PRA. The requirements associated with granting and withdrawal of deeming authority to national accreditation organizations, codified in 42 CFR part 488, ‘‘Survey, Certification, and Enforcement Procedures,’’ are currently approved by OMB under OMB approval number 0938–0690. VI. Regulatory Impact Statement We have examined the impact of this notice 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, when 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 will 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 notice 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 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 PO 00000 Frm 00078 Fmt 4703 Sfmt 4703 a substantial number of small rural hospitals. This notice merely recognizes AAAHC as a national accreditation organization that has approval for deeming authority for HMOs or PPOs that are participating in the MA program. 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 not have a 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 will not impose any costs on State or local governments, the requirements of E.O. 13132 are not applicable. In accordance with the provisions of Executive Order 12866, this notice was not reviewed by the Office of Management and Budget. Authority: Secs. 1851 and 1855 of the Social Security Act (42 U.S.C. 1395w–21 and 42 U.S.C. 1395w–25). (Catalog of Federal Domestic Assistance Program No. 93.773, Medicare—Hospital Insurance; and Program No. 93.774, Medicare—Supplementary Medical Insurance Program.) Dated: December 14, 2006. Leslie V. Norwalk, Acting Administrator, Centers for Medicare & Medicaid Services. [FR Doc. E7–1274 Filed 1–25–07; 8:45 am] BILLING CODE 4120–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [CMS–15357–CN2] RIN 0938–AO26 Medicare Program; Hospice Wage Index for Fiscal Year 2007; Correction Centers for Medicare & Medicaid Services (CMS), HHS. ACTION: Correction notice. AGENCY: SUMMARY: This document corrects a technical error that appeared in the E:\FR\FM\26JAN1.SGM 26JAN1

Agencies

[Federal Register Volume 72, Number 17 (Friday, January 26, 2007)]
[Notices]
[Pages 3854-3856]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-1274]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-4126-FN]


Medicare and Medicaid Programs; Reapproval 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 approve Medicare 
Advantage Deeming Authority of the Accreditation Association for 
Ambulatory Health Care, Inc. for health maintenance organizations and 
local preferred provider organizations for a term of 6 years.

[[Page 3855]]


DATES: Effective Date: This final notice is effective July 12, 2006 
through July 11, 2012.

FOR FURTHER INFORMATION CONTACT: Shaheen Halim, (410) 786-0641.

SUPPLEMENTARY INFORMATION:

I. Background

    Under the Medicare program, eligible beneficiaries may receive 
covered services through a managed care organization (MCO) that has a 
Medicare Advantage (MA) (formerly, Medicare+Choice) contract with the 
Centers for Medicare & Medicaid Services (CMS). The regulations 
specifying the Medicare requirements that must be met in order for an 
MCO to enter into an MA 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 MCO 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 MCO to be an MA organization, the MCO must be licensed by the State 
as a risk bearing organization as set forth in part 422 of our 
regulations. Additionally, the MCO must file an application 
demonstrating that it meets other Medicare requirements in part 422 of 
our regulations.
    Following approval of the MA contract, we engage in routine 
monitoring and oversight audits of the MA organization to ensure 
continuing compliance. The monitoring and oversight audit process is 
comprehensive and uses a written protocol that itemizes the Medicare 
requirements the MA organization must meet. As an alternative for 
meeting some Medicare requirements, an MA organization may be exempt 
from CMS monitoring of certain requirements as described in section 
1852(e)(4)(B) of the Social Security Act (the Act) as a result of an MA 
organization's accreditation by a CMS-approved accrediting organization 
(AO). In essence, the Secretary ``deems'' that the Medicare 
requirements are met based on a determination that the AO's standards 
are at least as stringent as Medicare requirements. Therefore, MA 
organizations that are licensed as health maintenance organizations 
(HMOs) or preferred provider organizations (PPOs) and are accredited by 
an approved accrediting organization may receive, at their request, 
deemed status for the MA requirements in the following six areas: 
Quality Improvement, Information on Advance Directives, 
Antidiscrimination, Confidentiality and Accuracy of Enrollee Records, 
Access to Services, and Provider Participation Rules. At this time, 
deeming does not include the Part D areas of review listed in Sec.  
422.156(b).
    Organizations that apply for MA deeming authority are generally 
recognized by the industry as entities that accredit MCOs that are 
licensed as an HMO or a PPO. As we specify at Sec.  422.157(b)(2) of 
our regulations, the term for which an AO may be approved by CMS may 
not exceed 6 years. For continuing approval, the AO must re-apply to 
CMS.
    Accreditation Association for Ambulatory Health Care, Inc. (AAAHC) 
was approved as an authorized AO for Medicare Advantage deeming on June 
15, 2002. AAAHC was granted a term of approval of 4 years beginning 
June 15, 2002, and ending on June 14, 2006. On June 13, 2006, we issued 
a letter to AAAHC with instructions regarding application for a renewal 
of term. On June 14, 2006, AAAHC submitted a letter of intent to renew 
its MA deeming authority, and subsequently submitted all materials 
requested by CMS for a complete renewal application. The materials 
requested by CMS included updates and/or changes to items listed in 
Federal regulations at 42 CFR 422.158(a) that are prerequisites for 
receiving deeming program approval by CMS, and which were furnished to 
CMS by AAAHC as part of its initial application for deeming authority 
in 2002.

II. Deeming Applications Approval Process

    Section 1852(e)(4)(C) 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. At the end of the 210-day period, we must 
publish an approval or denial of the application in the Federal 
Register.

III. Proposed Notice

    On October 27, 2006, we published a proposed notice (71 FR 63019) 
announcing reapproval of Medicare Advantage Deeming Authority of the 
Accreditation Association for Ambulatory Health Care, Inc. In the 
proposed notice, we detailed our evaluation criteria. Under section 
1852(e)(4) of the Act and our regulations at Sec.  422.158, we 
conducted a review and evaluation of the AAAHC's accreditation program 
(including its standards and monitoring protocol) in accordance with 
the criteria specified by our regulation, which includes, but are not 
limited to the following:

A. Components of the Review Process

    The review of AAAHC's application for approval of MA deeming 
authority included the following components:
1. Desk-Top Review
    We conducted a desk-top review of updated materials regarding 
AAAHC's managed care accreditation program, including--
     A description of AAAHC's survey process for managed care 
plans, including the frequency of surveys performed, whether the 
surveys are announced or unannounced, surveyor instructions, the review 
and accreditation status decision-making process, procedures used to 
notify accredited MA organizations of deficiencies and monitoring of 
the correction of deficiencies, and the procedures used to enforce 
compliance with accreditation requirements;
     Information about the individuals who perform network 
accreditation reviews, including the size and composition of the survey 
team, the methods of compensation, the education and experience 
requirements, the content and frequency of the in-service training, the 
evaluation system used to monitor performance, and conflict of interest 
requirements governing AAAHC staff and surveyors;
     A description of the data management and analysis system, 
the types (full, partial, or denial) and categories (provisional, 
conditional, temporary) of accreditation offered by AAAHC, the duration 
of each category of accreditation, and a statement identifying the 
types and categories that would serve as a basis for accreditation, if 
we grant AAAHC organization deeming authority;
     The procedures used to respond to and investigate 
complaints or identify other problems with accredited organizations, 
including coordination of these activities with licensing bodies and 
ombudsmen programs;
     A description of how AAAHC provides accreditation 
information to the general public;
     The policies and procedures for (1) withholding, denying 
and removing accreditation status, and the other actions AAAHC may take 
in response to noncompliance with their standards and requirements, and 
(2) how AAAHC treats accreditation of organizations that are acquired 
by another organization, have merged with another organization,

[[Page 3856]]

or that undergo a change of ownership or management;
     Lists of all AAAHC-accredited MA organizations, managed 
care plans surveyed by AAAHC in the past 3 years, and managed care 
plans that were scheduled to be surveyed by AAAHC within 3 months of 
submitting their application.
2. Assessment of AAAHC's Standards and Methods of Evaluation
    As part of the application for renewal of term, AAAHC submitted a 
crosswalk that compared its standards and methods of evaluations with 
corresponding MA audit requirements in six areas: Quality Improvement, 
Access to Services, Antidiscrimination, Information on Advance 
Directives, Provider Participation Rules, and Confidentiality and 
Accuracy of Enrollee Records.
3. Past Performance and Results of Deeming Validation Review (Look-
behind Audit)
    We also considered 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 Sec.  422.157(d).

B. Results of the Review Process

    Using the information listed in section III.A. of this notice, we 
determined that AAAHC's current accreditation program for managed care 
plans continues to be at least as stringent as the MA requirements 
contained in the six categories set forth in section 1852(e)(4)(C) of 
the Act and our methods of evaluation for those areas.

IV. Provisions of the Final Notice

    No comments were received in response to the proposed notice 
published October 27, 2006. Therefore, based on the review and 
observations described in section III of this final notice, we have 
determined that AAAHC's requirements for HMOs and local PPOs continue 
to meet or exceed our requirements. We recognize AAAHC as a national 
accreditation organization for HMOs and PPOs that request participation 
in the Medicare program, and we approve AAAHC's deeming program 
effective July 12, 2006 through July 11, 2012.

V. Collection of Information Requirements

    This final notice does not impose any information collection and 
record keeping requirements subject to the Paperwork Reduction Act 
(PRA). Consequently, it does not need to be reviewed by the Office of 
Management and Budget (OMB) under the authority of the PRA. The 
requirements associated with granting and withdrawal of deeming 
authority to national accreditation organizations, codified in 42 CFR 
part 488, ``Survey, Certification, and Enforcement Procedures,'' are 
currently approved by OMB under OMB approval number 0938-0690.

VI. Regulatory Impact Statement

    We have examined the impact of this notice 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, when 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 
will 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 notice 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 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.
    This notice merely recognizes AAAHC as a national accreditation 
organization that has approval for deeming authority for HMOs or PPOs 
that are participating in the MA program.
    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 not 
have a 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 will not impose any costs on State or 
local governments, the requirements of E.O. 13132 are not applicable.
    In accordance with the provisions of Executive Order 12866, this 
notice was not reviewed by the Office of Management and Budget.

    Authority: Secs. 1851 and 1855 of the Social Security Act (42 
U.S.C. 1395w-21 and 42 U.S.C. 1395w-25).

(Catalog of Federal Domestic Assistance Program No. 93.773, 
Medicare--Hospital Insurance; and Program No. 93.774, Medicare--
Supplementary Medical Insurance Program.)

    Dated: December 14, 2006.
Leslie V. Norwalk,
Acting Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. E7-1274 Filed 1-25-07; 8:45 am]
BILLING CODE 4120-01-P
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