[Federal Register Volume 74, Number 166 (Friday, August 28, 2009)]
[Notices]
[Pages 44370-44371]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-20203]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-2299-FN]


Medicare and Medicaid Programs; Application of the American 
Osteopathic Association for Continued Deeming Authority for Hospitals

AGENCY: Centers for Medicare and 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 continued recognition as a national 
accreditation program for hospitals seeking to participate in the 
Medicare or Medicaid programs.

DATES: Effective Date: This final notice is effective September 25, 
2009 through September 25, 2013.

FOR FURTHER INFORMATION CONTACT: Lillian Williams, (410) 786-8636. 
Patricia Chmielewski, (410) 786-6899.

SUPPLEMENTARY INFORMATION:

I. Background

    Under the Medicare program, eligible beneficiaries may receive 
covered services from a hospital provided certain requirements are met. 
The regulations specifying the Medicare conditions of participation 
(CoPs) for hospitals are located at 42 CFR part 482. These conditions 
implement section 1861(e) of the Social Security Act (the Act), which 
specifies services covered as hospital care and the conditions that a 
hospital program must meet in order to participate in the Medicare 
program.
    Regulations concerning provider agreements are located at 42 CFR 
part 489 and those pertaining to activities relating to the survey and 
certification of facilities are located at 42 CFR part 488.
    Generally, in order to enter into a provider agreement, a hospital 
must first be certified by a State survey agency as complying with the 
conditions or requirements set forth in the statute and part 482 of the 
regulations. Then, the hospital is subject to routine State agency 
surveys to determine whether it continues to meet the Medicare 
requirements. There is an alternative, however, to State compliance 
surveys.
    Section 1865(a)(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.
    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 
accreditation organization approved program would be deemed to meet the 
Medicare conditions. Accreditation by an accreditation organization is 
voluntary and is not required for Medicare participation.
    A national accreditation organization applying for 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 the reapproval of accreditation 
organizations are set forth at Sec.  488.4 and Sec.  488.8(d)(3). The 
regulations at Sec.  488.8(d)(3) require accreditation organizations to 
reapply for continued deeming authority every 6 years or sooner as 
determined by CMS.
    AOA's term of approval as a recognized accreditation program for 
hospitals expires September 25, 2009.

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 a complete application, with any documentation necessary to 
make a determination, to complete our survey activities and application 
review. Within 60 days of receiving a complete application, we must 
publish a notice in the Federal Register that identifies the national 
accreditation organization making the request, describes the request, 
and provides no less that 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. Provisions of the Proposed Notice and Response to Comments

    On April 24, 2009, we published a proposed notice in the Federal 
Register (74 FR 18728) announcing AOA's request for reapproval as a 
deeming organization for hospitals. In this notice, we detailed the 
evaluation criteria. Under section 1865(a)(2) of the Act and our 
regulations at Sec.  488.4, we conducted a review of the AOA's 
application in accordance with the criteria specified by our 
regulations, which include, but are not limited to the following 
factors:
    <bullet> 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.
    <bullet> A comparison of AOA's hospital accreditation standards to 
our current Medicare hospital CoPs.
    <bullet> A documentation review of AOA's survey processes to:
    + Determine the composition of the survey team, surveyor 
qualifications, and AOA's ability 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 AOA identifies noncompliance. 
If noncompliance is identified through validation reviews, the State 
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 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.
    + 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(a)(3)(A) of the Act, the April 24, 
2009 proposed notice also solicited public comments regarding whether

[[Page 44371]]

AOA's requirements met or exceeded the Medicare CoPs for hospitals. We 
received 28 comments in response to our proposed notice.
    All commenters expressed support for AOA's continued deeming 
authority for hospitals. Commenters stated that AOA's standards are 
clearly written and closely aligned with the Medicare CoPs, and that 
AOA's accreditation program provides hospitals with a viable 
alternative to other healthcare accreditation organizations.

IV. Provision of the Final Notice

A. Differences Between AOA's Standards and Requirements for 
Accreditation and Medicare's Conditions and Survey Requirements

    We compared AOA's hospital accreditation requirements and survey 
process with the Medicare CoPs and survey process as outlined in the 
State Operations Manual (SOM). Our review and evaluation of AOA's 
deeming application, which were conducted as described in section III 
of this final notice, yielded the following:
    <bullet> AOA revised its standards to ensure that a medical history 
and physical is completed and documented in accordance with the 
requirements at Sec.  482.51(b)(1).
    <bullet> To meet the requirements in the SOM Appendix A, AOA 
amended its surveyor team handbook to ensure all hospital survey teams 
include a Registered Nurse.
    <bullet> AOA modified its policies related to the accreditation 
effective date in accordance with the requirements at Sec.  489.13.
    <bullet> AOA modified its policies regarding timeframes for sending 
and receiving a plan of correction (PoC) in accordance with section 
2728 of the SOM.
    <bullet> AOA revised its policies to include timeframes for 
investigation of complaints in accordance with the requirements at 
section 5075.9 of the SOM.
    <bullet> AOA developed and implemented internal monitoring 
procedures to ensure its surveyors are trained and qualified to meet 
the requirements at Sec.  488.4(a)(4).
    <bullet> AOA developed an action plan to ensure that deemed status 
survey files are complete, accurate, and consistent with the 
requirements at Sec.  488.6(a).
    <bullet> AOA developed and conducted surveyor training on the 
documentation of deficiencies to ensure that all cited deficiencies 
contain a regulatory reference, a clear and detailed description of the 
deficient practice, and relevant finding.
    <bullet> To meet the requirements at Sec.  488.20(a) and Sec.  
488.28(a), AOA developed a policy to ensure that facilities with 
condition level non-compliance on a recertification survey submit an 
acceptable PoC, and receive a follow up onsite focused survey.
    <bullet> To meet the requirements at section 2005A2 of the SOM, AOA 
revised its policies and developed an internal tracking tool to ensure 
that facilities with condition level non-compliance on an initial 
survey receive an onsite follow-up full survey.
    <bullet> To meet the requirements at Sec.  488.4(b), AOA developed 
and incorporated measures to improve the accuracy and consistency of 
data submissions to CMS.
    <bullet> To meet the requirements at 2700A of the SOM, AOA revised 
its policies on blackout dates.
    <bullet> AOA revised its accreditation decision letters to ensure 
that they are accurate and contain all the required elements for the 
CMS Regional Office to render a decision regarding the deemed status of 
an accredited hospital.
    <bullet> To meet the survey process requirements in Appendix A of 
the SOM, AOA developed a policy outlining the minimum number of 
inpatient records required for review during a certification survey.
    <bullet> AOA removed all references to mandatory consultative 
services from its policies to avoid potential conflict of interest 
issues.
    <bullet> To verify AOA's continued compliance with the provisions 
of this final notice, CMS will conduct a follow-up corporate onsite 
visit within one year of the date of publication of this notice.

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 
hospitals meet or exceed our requirements. Therefore, we approve AOA as 
a national accreditation organization for hospitals that request 
participation in the Medicare program, effective September 25, 2009 
through September 25, 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).

VI. Regulatory Impact Statement

    In accordance with the provisions of Executive Order 12866, this 
regulation was not reviewed by the Office of Management and Budget.

    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)

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

    Dated: July 30, 2009.
Charlene Frizzera,
Acting Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. E9-20203 Filed 8-27-09; 8:45 am]
BILLING CODE 4120-01-P