[Federal Register: January 26, 2007 (Volume 72, Number 17)]
[Notices]
[Page 3854-3856]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr26ja07-126]
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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.
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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