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[Federal Register Volume 76, Number 185 (Friday, September 23, 2011)]
[Notices]
[Pages 59134-59136]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-24496]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-2375-FN]

Medicare and Medicaid Programs; Approval of the Joint 
Commission's Continued 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 Joint 
Commission for continued 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 November 21, 2011 
through November 21, 2017.

FOR FURTHER INFORMATION CONTACT:

L. Tyler Whitaker, (410) 786-5236.
Patricia Chmielewski, (410) 786-6899.

SUPPLEMENTARY INFORMATION:

I. Background

    Under the Medicare program, eligible beneficiaries may receive 
covered services in a critical access hospital (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. The minimum requirements that a CAH must 
meet to participate in Medicare are set forth in regulations at 42 CFR 
part

[[Page 59135]]

485, subpart F. Conditions for Medicare payment for CAHs are set forth 
at Sec.  413.70. Applicable regulations concerning provider agreements 
are located in 42 CFR part 489 and those pertaining to facility survey 
and certification are located in 42 CFR part 488, subparts A and B.
    For a CAH to enter into a provider agreement with the Medicare 
program, a CAH must first be certified by a State survey agency as 
complying with the conditions or requirements set forth in section 1820 
of the Act, and 42 CFR part 485 of the regulations. Subsequently, the 
CAH is subject to ongoing review by a State survey agency to determine 
whether it continues to meet the Medicare requirements. However, there 
is an alternative to State compliance surveys. Certification by a 
nationally recognized accreditation program can substitute for ongoing 
State review.
    Section 1865(a)(1) of the Act stipulates that, if a provider entity 
demonstrates through accreditation by an approved national 
accreditation organization (AO) that all applicable Medicare conditions 
are met or exceeded, we may ``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 deeming 
authority under 42 CFR part 488, subpart A must provide us 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 reapproval of AO's are set forth at 
Sec.  488.4 and Sec.  488.8(d)(3). The regulations at Sec.  488.8(d)(3) 
require AO's to reapply for continued approval of deeming authority 
every 6 years, or sooner as we determine. The Joint Commission's term 
of approval as a recognized accreditation program for CAHs expires 
November 21, 2011.
    We received a complete application from the Joint Commission for 
continued recognition as a national accrediting organization for CAHs 
on April 1, 2011. In accordance with the requirements at Sec.  488.4 
and Sec.  488.8(d)(3), we published a proposed notice on May 13, 2011 
(76 FR 30107). This final notice is required to be published no later 
than November 21, 2011.

II. Deeming Application Approval Process

    Section 1865(a)(3)(A) of the Act provides a statutory timetable to 
ensure that our review of applications for deeming authority is 
conducted in a timely manner. The statute provides us 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 process. Within 60 days after receiving a 
complete 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 
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 and Response to Comments

    In the May 13, 2011 Federal Register (76 FR 28040), we published a 
proposed notice announcing the Joint Commission's request for continued 
approval as a deeming organization for critical access hospitals. 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 we 
conducted a review of the Joint Commission'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 the Joint Commission's:
    ++ Corporate policies.
    ++ Financial and human resources available to accomplish the 
proposed surveys.
    ++ Procedures for training, monitoring, and evaluation of its 
surveyors.
    ++ Ability to investigate and respond appropriately to complaints 
against accredited facilities.
    ++ Survey review and decision-making process for accreditation.
     A comparison of the Joint Commission's CAH accreditation 
standards to our current Medicare CAH conditions of participation 
(CoPs).
     A documentation review of the Joint Commission's survey 
processes to:
    ++ Determine the composition of the survey team, surveyor 
qualifications, and the Joint Commission's ability to provide 
continuing surveyor training.
    ++ Compare the Joint Commission'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 the Joint Commission's procedures for monitoring CAHs 
found to be out of compliance with the Joint Commission's program 
requirements. The monitoring procedures are used only when the Joint 
Commission identifies noncompliance. If noncompliance is identified 
through validation reviews, the State survey agency monitors 
corrections as specified at Sec.  488.7(d).
    ++ Assess the Joint Commission's ability to report deficiencies to 
the surveyed facilities and respond to the facility's plan of 
correction in a timely manner.
    ++ Establish the Joint Commission's ability to provide us with 
electronic data and reports necessary for effective validation and 
assessment of the Joint Commission's survey process.
    ++ Determine the adequacy of staff and other resources.
    ++ Review the Joint Commission's ability to provide adequate 
funding for performing required surveys.
    ++ Confirm the Joint Commission's policies with respect to whether 
surveys are announced or unannounced.
    ++ Obtain the Joint Commission'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 May 13, 
2011 proposed notice also solicited public comments regarding whether 
the Joint Commission's requirements meet or exceed the Medicare CoPs 
for CAHs. We received one comment in response to our proposed notice.
    The commenter expressed strong support for the Joint Commission's 
application for CAH deeming authority. The commenter stated that the 
Joint Commission's standards are clearly written and closely align with 
the Medicare CoPs, and that the Joint Commission's accreditation 
program provides CAHs with a viable alternative to other healthcare 
AOs.

IV. Provisions of the Final Notice

A. Differences Between the Joint Commission's Standards and 
Requirements for Accreditation and Medicare's Conditions and Survey 
Requirements

    We compared the Joint Commission's CAH 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 the Joint Commission's deeming application, which were 
conducted as described in section III of this final notice, yielded the 
following:
     To meet the requirements at Sec.  485.618(c)(2), the Joint 
Commission revised its crosswalk to include the requirement that an 
organization's

[[Page 59136]]

medical staff and the person directly responsible for operation of the 
facility approve contractual agreements.
     To meet the requirements at Sec.  485.623(b)(2), the Joint 
Commission revised its crosswalk and survey process to address the 
proper routine storage and prompt disposal of trash.
     To meet the requirements at Sec.  485.631(c)(2), the Joint 
Commission revised its crosswalk to address the requirement that 
physician assistants, nurse practitioners, or clinical nurse 
specialists provide services in accordance with the CAH's policies.
     To meet the requirements at Sec.  485.635(a)(3)(iii), the 
Joint Commission revised its standards to include guidelines for the 
maintenance of health care records, and procedures for the periodic 
review and evaluation of the services furnished by the CAH.
     To meet the requirements at Sec.  485.635(f) through 
(f)(2), the Joint Commission revised its crosswalk to include the 
patient visitation right standards and related survey process 
revisions.
     To meet the requirements at Sec.  485.638(a)(2), the Joint 
Commission revised its crosswalk to address the requirement that 
medical records are readily accessible.
     To meet the requirements at Sec.  485.639(b)(1), the Joint 
Commission revised its standards to include the requirement that a 
qualified practitioner must examine the patient immediately before 
surgery to evaluate the risk of the procedure to be performed.
     To meet the requirements at Sec.  485.639(b)(2), the Joint 
Commission revised its standards to include the requirement that a 
qualified practitioner examine each patient before surgery to evaluate 
the risk of anesthesia.
     To meet the requirements at Sec.  485.639(b)(3), the Joint 
Commission revised its standards to address the requirement that a 
qualified practitioner must evaluate each patient for proper anesthesia 
recovery before discharge from the CAH.
     To meet the requirements at Sec.  485.643(f), the Joint 
Commission revised its glossary to ensure that the definition of organ 
includes ``intestines (or multivisceral organs).''
     To meet the requirements at Sec.  485.645(d)(1), the Joint 
Commission revised its crosswalk to include standards which address the 
residents' right to send and receive mail that is not opened.
     To meet the requirements at Sec.  412.27(d)(6)(i), the 
Joint Commission revised its crosswalk to include the requirement that 
programs be directed toward restoring and maintaining optimal levels of 
physical and psychosocial functioning.
     To meet the requirements at Sec.  412.29(c), the Joint 
Commission revised it crosswalk to include standards to ensure patients 
receive social services, psychological services (including 
neuropsychological services), orthotic and prosthetic services, as 
needed.
     To meet the requirements at Sec.  482.13(h) through 
(h)(4), the Joint Commission revised its crosswalk to include the 
patient visitation right standards and related survey process 
revisions.
     To meet the requirements at Sec.  482.30(d)(3), the Joint 
Commission revised its standards to ensure that written notification 
regarding the admission to or continued stay in the hospital when it is 
not medically necessary, is given no later than 2 days after this 
determination has been made.
     To meet the requirements at Sec.  482.41(b)(1)(i), the 
Joint Commission revised its standards to require quarterly testing of 
tamper and water flow devices.
     To meet the requirements at Sec.  482.41(b)(8), the Joint 
Commission revised its standards to ensure the CAH maintains written 
evidence of regular inspections and approval by State or local fire 
control agencies for the entire CAH.
     To meet the requirements at Sec.  482.51, the Joint 
Commission revised its standards to ensure that if the hospital 
provides surgical services, the services are well organized and 
provided in accordance with acceptable standards of practice and if 
outpatient surgical services are offered the services must be 
consistent in quality with inpatient care in accordance with the 
complexity of services offered.
     To meet the requirements at Sec.  488.4(a)(7), the Joint 
Commission revised its survey process to include policies and 
procedures with respect to the withholding or removal of accreditation 
status or requirements, and other actions taken by the Joint Commission 
in response to noncompliance with standards and requirements.
     To meet the requirements at section 2728 of the State 
Operations Manual (SOM), the Joint Commission modified its policies 
regarding timeframes for sending and receiving a plan of correction 
(PoC).
     To meet the requirements at Sec.  488.12, the Joint 
Commission modified its policies and procedures to ensure its survey 
files are complete.

B. Term of Approval

    Based on the review and observations described in section III of 
this final notice, we have determined that the Joint Commission's 
requirements for CAHs meet or exceed our requirements. Therefore, we 
approve the Joint Commission as a national accreditation organization 
for CAHs that request participation in the Medicare program, effective 
November 21, 2011 through November 21, 2017.

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. 93.773, 
Medicare--Hospital Insurance; and Program No. 93.774, Medicare--
Supplementary Medical Insurance Program)

    Dated: August 31, 2011.
Donald M. Berwick,
Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2011-24496 Filed 9-22-11; 8:45 am]
BILLING CODE 4120-01-P
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