[Federal Register Volume 78, Number 230 (Friday, November 29, 2013)]
[Notices]
[Pages 71619-71620]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-28521]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-3285-FN]


Medicare and Medicaid Programs; Continued Approval of American 
Osteopathic Association/Healthcare Facilities Accreditation Program's 
Critical Access Hospital Accreditation Program

AGENCY: Centers for Medicare & Medicaid Services, HHS.

ACTION: Final notice.

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

SUMMARY: This final notice announces our decision to approve the 
American Osteopathic Association/Healthcare Facilities Accreditation 
Program (AOA/HFAP) for continued recognition as a national accrediting 
organization (AO) for critical access hospitals (CAH) that wish to 
participate in the Medicare or Medicaid programs.

DATES: This final notice is effective December 27, 2013 through 
December 27, 2019.

FOR FURTHER INFORMATION CONTACT:

James Cowher, (410) 786-41948,
Cindy Melanson, (410) 786-0310, or 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), 1820(e), and 1861(mm)(1) of the Social Security 
Act (the Act) establish distinct criteria for facilities seeking 
designation as a CAH. Regulations concerning provider agreements are at 
42 CFR part 489 and those pertaining to activities relating to the 
survey and certification of facilities are at 42 CFR part 488. The 
regulations at 42 CFR 485, subpart F specify the conditions that a CAH 
must meet to participate in the Medicare program, the scope of covered 
services, and the conditions for Medicare payment for CAHs.
    Generally, to enter into an agreement, a CAH must first be 
certified by a state survey agency as complying with the conditions or 
requirements set forth in part 485, subpart F. Thereafter, the CAH is 
subject to regular surveys by a state survey agency to determine 
whether it continues to meet these requirements. However, there is an 
alternative to surveys by state agencies. Certification by a nationally 
recognized accreditation program can substitute for ongoing state 
review.
    Section 1865(a)(1) of the Act provides that, if a provider entity 
demonstrates through accreditation by an approved national AO that all 
applicable Medicare conditions are met or exceeded, we will deem those 
provider entities as having met the requirements. Accreditation by an 
AO is voluntary and is not required for Medicare participation. A 
national AO applying for approval of its accreditation program under 
part 488, subpart A, must provide CMS with reasonable assurance that 
the AO requires the accredited provider entities to meet requirements 
that are at least as stringent as the Medicare conditions.
    Our regulations concerning the approval of AOs are set forth at 
Sec.  488.4 and Sec.  488.8(d)(3). The regulations at Sec.  488.8(d)(3) 
require AOs to reapply for continued approval of its accreditation 
program every 6 years or sooner as determined by CMS. The AOA/HFAP's 
current term of approval for their CAH accreditation program expires 
December 27, 2013.

II. Application Approval Process

    Section 1865(a)(3)(A) of the Act provides a statutory timetable to 
ensure that our review of applications for CMS-approval of an 
accreditation program is conducted in a timely manner. The Act provides 
us 210 days after the date of receipt of a complete application, with 
any documentation necessary to make the determination, to complete our 
survey activities and application process. Within 60 days after 
receiving a complete application, we must publish a notice in the 
Federal Register that identifies the national accrediting body making 
the request, describes the request, and provides no less than a 30-day 
public comment period. At the end of the 210-day period, we must 
publish a notice in the Federal Register approving or denying the 
application.

III. Provisions of the Proposed Notice

    On June 25, 2013, we published a proposed notice in the Federal 
Register (78 FR 38043) announcing AOA/HFAP's request for approval of 
its CAH accreditation program. In the proposed notice, we detailed our 
evaluation criteria. Under section 1865(a)(2) of the Act and in our 
regulations at Sec.  488.4 and Sec.  488.8, we conducted a review of 
AOA/HFAP's application in accordance with the criteria specified by our 
regulations, which include, but are not limited to the following:
     An onsite administrative review of AOA/HFAP'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 decisionmaking process for accreditation.
     The comparison of AOA/HFAP's accreditation to our current 
Medicare CAH conditions of participation (CoPs).
     A documentation review of AOA/HFAP's survey process to:
    ++ Determine the composition of the survey team, surveyor 
qualifications, and AOA/HFAP's ability to provide continuing surveyor 
training.
    ++ Compare AOA/HFAP'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/HFAP's procedures for monitoring CAHs out of 
compliance with AOA/HFAP's program requirements. The monitoring 
procedures are used only when AOA/HFAP identifies noncompliance. If 
noncompliance is identified through validation reviews, the state 
survey agency monitors corrections as specified at Sec.  488.7(d).

[[Page 71620]]

    ++ Assess AOA/HFAP's ability to report deficiencies to the surveyed 
facilities and respond to the facility's plan of correction in a timely 
manner.
    ++ Establish AOA/HFAP's ability to provide us with electronic data 
and reports necessary for effective validation and assessment of the 
organization's survey process.
    ++ Determine the adequacy of staff and other resources.
    ++ Confirm AOA/HFAP's ability to provide adequate funding for 
performing required surveys.
    ++ Confirm AOA/HFAP's policies with respect to whether surveys are 
announced or unannounced.
    ++ Obtain AOA/HFAP'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 June 25, 
2013 proposed notice also solicited public comments regarding whether 
AOA/HFAP's requirements met or exceeded the Medicare conditions of 
participation for CAHs. We received no comments in response to our 
proposed notice.

IV. Provisions of the Final Notice

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

    We compared AOA/HFAP's CAH 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/HFAP's CAH application, 
which were conducted as described in section III of this final notice, 
yielded the following:
     To meet the requirements at Sec.  485.623(b)(5), AOA/HFAP 
revised its standards to require all ventilation systems, both new and 
existing, supplying operating rooms to meet the humidity control 
requirements..
     To meet the requirements at Sec.  485.623(c)(1), AOA/HFAP 
revised its standards to incorporate specific staff training 
requirements for protection in place or methods for the evacuation of 
patients, when necessary.
     To meet the requirements at Sec.  485.635(e), AOA/HFAP 
revised its standards to include staff qualification requirements for 
rehabilitation therapy services.
     To meet the requirements at Sec.  488.4(a)(6), AOA/HFAP 
revised its ``Complaint/Incident Management Policy,'' to ensure all 
onsite complaint surveys are documented on a survey report.
     To meet the requirements of section 2728 of the SOM, AOA/
HFAP will continue to use its internal monitoring plan to ensure 
timeframes for sending or receiving a plan of correction (PoC) are met.
     To meet the requirements of section 2728B of the SOM, AOA/
HFAP will continue to conduct monthly internal audits to ensure 
accepted PoC's contain all of the required elements.

B. Term of Approval

    Based on our review and observations described in section III of 
this final notice, we have determined that AOA/HFAP's CAH accreditation 
program requirements meet or exceed our requirements. Therefore, we 
approve AOA/HFAP as a national AO for CAHs that request participation 
in the Medicare program, effective December 27, 2013 through December 
27, 2019.

V. Collection of Information Requirements

    This document does not impose information collection, recordkeeping 
or third party disclosure 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. Chapter 35).

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

    Dated: November 12, 2013.
Marilyn Tavenner,
Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2013-28521 Filed 11-27-13; 8:45 am]
BILLING CODE 4120-01-P