[Federal Register Volume 72, Number 225 (Friday, November 23, 2007)]
[Notices]
[Pages 65738-65740]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-22628]


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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

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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