[Federal Register: November 23, 2007 (Volume 72, Number 225)]
[Notices]
[Page 65738-65740]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr23no07-78]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-2272-FN]
Medicare and Medicaid Programs; Approval of the American
Osteopathic Association's Deeming Authority for Critical Access
Hospitals
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Final notice.
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SUMMARY: This notice announces our decision to approve the American
Osteopathic Association (AOA) for recognition as a national
accreditation program for critical access hospitals (CAHs) seeking to
participate in the Medicare or Medicaid programs.
DATES: Effective Date: This final notice is effective December 28, 2007
through December 28, 2013.
FOR FURTHER INFORMATION CONTACT:
Cindy Melanson, (410) 786-0310.
Patricia Chmielewski, (410) 786-6899.
SUPPLEMENTARY INFORMATION:
I. Background
Under the Medicare program, eligible beneficiaries may receive
covered services in a CAH provided certain requirements are met.
Sections 1820(c)(2)(B) and 1861(mm) of the Social Security Act (the
Act) establish distinct criteria for facilities seeking designation as
a CAH. Under this authority, the minimum requirements that a CAH must
meet to participate in Medicare are set forth in regulations at 42 CFR
part 485, subpart F (Conditions of Participation: Critical Access
Hospitals (CAHs)) which determine the basis and scope of CAH covered
services. Conditions for Medicare payment for CAHs can be found at 42
CFR 413.70. Applicable regulations concerning provider agreements are
at 42 CFR part 489 (Provider Agreements and Supplier Approval) and
those pertaining to facility survey and certification are at part 488,
subparts A and B.
A. Verifying Medicare Conditions of Participation
In general, we approve a CAH for participation in the Medicare
program if it is participating as a hospital at the time it applies for
CAH designation, and it is in compliance with parts 482 (Conditions of
Participation for Hospitals) and 485, subpart F (Conditions of
Participation: Critical Access Hospital (CAHs)).
For a CAH to enter into a provider agreement, a State survey agency
must certify that the CAH is in compliance with the conditions or
standards set forth in Section 1820 of the Social Security Act and part
485 of our regulations. Thereafter, the CAH is subject to ongoing
review by a State survey agency to determine whether it continues to
meet the Medicare requirements. There is, however, an alternative to
State compliance surveys. Certification by a nationally-recognized
accreditation program can substitute for ongoing State review.
Section 1865(b)(1) of the Act provides that, if a provider entity
demonstrates through accreditation by an approved national
accreditation organization that all applicable Medicare conditions are
met or exceeded, we may ``deem'' those provider entities as having met
the requirements. Accreditation by an accreditation organization is
voluntary and is not required for Medicare participation.
If an accreditation organization is recognized by the Secretary as
having standards for accreditation that meet or exceed Medicare
requirements, a provider entity accredited by the national accrediting
body's approved program may be deemed to meet the Medicare conditions.
A national accreditation organization applying for approval of deeming
authority under part 488, subpart A must provide us with reasonable
assurance that the accreditation organization requires the accredited
provider entities to meet requirements that are at least as stringent
as the Medicare conditions. Our regulations concerning re-approval of
accrediting organizations are set forth at section Sec. 488.4 and
Sec. 488.8(d)(3). The regulations at Sec. 488.8(d)(3) require
accreditation organizations to reapply for continued approval of
deeming authority every six years, or sooner as we determine. The
American Osteopathic Association's (AOA) term of approval as a
recognized accreditation program for CAHs expires December 27, 2007.
II. Deeming Applications Approval Process
Section 1865 (b) (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
[[Page 65739]]
comment period. At the end of the 210-day period, we must publish an
approval or denial of the application.
III. Proposed Notice
On July 27, 2007, we published a proposed notice (72 FR 41331)
announcing the AOA's request for re-approval as a deeming organization
for CAHs. In the proposed notice, we detailed our evaluation criteria.
Under section 1865(b)(2) of the Act and our regulations at Sec. 488.4
(Application and reapplication procedures for accreditation
organizations), we conducted a review of the AOA application in
accordance with the criteria specified by our regulation, which
include, but are not limited to the following:
An onsite administrative review of AOA's (1) corporate
policies; (2) financial and human resources available to accomplish the
proposed surveys; (3) procedures for training, monitoring, and
evaluation of its surveyors; (4) ability to investigate and respond
appropriately to complaints against accredited facilities; and (5)
survey review and decision-making process for accreditation;
A comparison of AOA's CAH accreditation standards to our
current Medicare CAH conditions for participation; and,
A documentation review of AOA's survey processes to:
Determine the composition of the survey team, surveyor
qualifications, and the ability of AOA to provide continuing surveyor
training;
Compare AOA's processes to those of State survey agencies,
including survey frequency, and the ability to investigate and respond
appropriately to complaints against accredited facilities;
Evaluate AOA's procedures for monitoring providers or
suppliers found to be out of compliance with AOA program requirements.
The monitoring procedures are used only when the AOA identifies
noncompliance. If noncompliance is identified through validation
reviews, the survey agency monitors corrections as specified at Sec.
488.7(d);
Assess AOA's ability to report deficiencies to the
surveyed facilities and respond to the facility's plan of correction in
a timely manner;
Establish AOA's ability to provide us with electronic data
in ASCII-comparable code and reports necessary for effective validation
and assessment of AOA's survey process;
Determine the adequacy of staff and other resources;
Review AOA's ability to provide adequate funding for
performing required surveys;
Confirm AOA's policies with respect to whether surveys are
announced or unannounced; and
Obtain AOA's agreement to provide us with a copy of the
most current accreditation survey together with any other information
related to the survey as we may require, including corrective action
plans.
In accordance with section 1865(b)(3)(A) of the Act, the July 27,
2007 proposed notice (72 FR 41331) also solicited public comments
regarding whether AOA's requirements met or exceeded the Medicare
conditions of participation for CAHs. We received no public comments in
response to our proposed notice.
IV. Provisions of the Final Notice
A. Differences Between the AOA's Standards and Requirements for
Accreditation and Medicare's Conditions and Survey Requirements
We compared the standards contained in AOA's accreditation
requirements for CAHs and its survey process in AOA's Application for
Renewal of Deeming Authority for CAH Facilities with the Medicare CAH
conditions for participation and our State Operations Manual. Our
review and evaluation of AOA's deeming application, which were
conducted as described in section III of this final notice, yielded the
following:
AOA provided a list of trained surveyors that are able to
provide consultative services to requesting facilities. In order to
eliminate any real or perceived conflict of interest between the AOA's
accreditation activities and AOA's list of surveyors able to provide
consultation, AOA has formalized policies and procedures that
adequately cover the conflict of interest process for surveyors that
provide consultations;
AOA has revised its complaint policies to address
timeframes for addressing complaints that involve immediate jeopardy;
AOA modified its application process for facilities
undergoing a certification or recertification survey to allow fewer
``black-out'' dates to address CMS' concern of ensuring that surveys
conducted by AOA comply with CMS' policy of unannounced surveys;
AOA formalized a process to ensure that all surveyors are
receiving an annual performance evaluation;
AOA added standards to their CAH Manual to meet the
requirements at Sec. 485.603 rural health network, Sec. 485.604
Personnel qualification, Sec. 485.606 Designation and certification of
CAHs, Sec. 485.610 Status and location, and Sec. 485.612 Compliance
with hospital requirements at the time of application;
In order to meet the requirements at Sec. 485.616(b), AOA
added language to its standards to address agreements for credentialing
and quality assurance requirements for CAHs that are members of a rural
health network;
To meet the requirements at Sec. 485.623(a), AOA revised
its standard at 11.00.01 to address the requirement of adequate space
for the provision of direct services;
To meet the requirements at Sec. 485.623(d)(7), AOA
revised its standards to address alcohol based hand rubs;
AOA revised its standards to address the supervision
requirements for patients cared for by nurse practitioners, clinical
nurse specialists, certified nurse midwives, and physician assistants
in order to meet the requirements at Sec. 485.631(b)(1)(v) and Sec.
485.631(b)(1)(vi);
In order to meet the requirements at Sec. 485.635(a)(1),
AOA added clarifying language to specify that health care services
provided in the CAH are consistent with applicable State laws;
To meet the requirements of Sec. 485.635(a)(2), AOA added
language to its standard to address the requirement that policies are
developed with at least one member of a group of professional personnel
that is not a member of the CAH staff;
In order to meet the requirements of Sec.
485.635(a)(3)(vii), AOA inserted language to address the requirements
at Sec. 483.25(i) with respect to inpatients receiving post-hospital
skilled nursing facility (SNF) care;
AOA revised its standard to include a representative
sample of active and closed records in the periodic evaluation of its
total program in order to meet the requirements at Sec.
485.641(a)(1)(ii);
AOA added language to its standards to address the
requirements at Sec. 482.30(b)(1) through Sec. 482.30(b)(3) regarding
requirements for utilization review;
In order to meet the additional criteria in a distinct
part unit of the CAH, the language addressed in the Medicare
requirements Sec. 412.25 Excluded hospital units: Common requirements
and Sec. 412.29 Excluded rehabilitation units: Additional requirements
were adopted and added to AOA standards;
AOA added additional standards to meet the eligibility
requirements for CAH distinct part units found at Sec. 485.647;
Once AOA has implemented their revised standards, CMS will
conduct a survey observation at the next available
[[Page 65740]]
opportunity to validate proper application of the standards.
In order to meet the requirements of Sec. 488.8(a)(2)(v),
AOA has agreed to provide CMS with timely electronic data for effective
validation and assessment of the organization's survey process; and
To comply with the Medicare requirements of conducting
unannounced certification and recertification surveys, AOA revised its
survey procedures to prohibit any advance mailings of surveyor
materials to the facility prior to the survey and will not permit the
hospital to mail back the surveyor findings to AOA after completion of
the survey.
B. Term of Approval
Based on the review and observations described in section III of
this final notice, we have determined that AOA's requirements for CAHs
meet or exceed our requirements. Therefore, we approve the AOA as a
national accreditation organization for CAHs that request participation
in the Medicare program, effective December 28, 2007 through December
28, 2013.
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: October 11, 2007.
Kerry Weems,
Acting Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. E7-22628 Filed 11-21-07; 8:45 am]
BILLING CODE 4120-01-P