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