[Federal Register: October 24, 2008 (Volume 73, Number 207)]
[Notices]
[Page 63480-63483]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr24oc08-84]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-2896-FN]
Medicare and Medicaid Programs; Conditional Approval of the Joint
Commission's Continued Deeming Authority for Critical Access Hospitals
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Conditional Notice of Approval.
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SUMMARY: This notice announces our decision to conditionally approve,
with a probationary period, the Joint Commission's request 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 conditional notice of approval is effective
November 21, 2008 through November 21, 2011, with a 180-day
probationary period through May 20, 2009.
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. Accreditation 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
[[Page 63481]]
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 Joint
Commission's term of approval as a recognized accreditation program for
CAHs expires November 21, 2008.
II. Deeming Applications Approval Process
Section 1865(b)(3)(A) of the Act, recodified under the Medicare
Improvements for Patients and Providers Act of 2008 (Pub. L. 110-275,
July 15, 2008)(MIPPA) as section 1865(a)(3)(A), 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 to conduct our
survey activities and application review process. Within 60 days of
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 an approval or denial of the application.
III. Provisions of the Proposed Notice and Response to Comments
On May 23, 2008, we published a proposed notice (73 FR 30107)
announcing the Joint Commission'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 (now section
1865(a)(2))and our regulations at Sec. 488.4 (Application and
reapplication procedures for accreditation organizations), we conducted
a review of the Joint Commission application in accordance with the
criteria specified by our regulation, which include, but are not
limited to the following:
An onsite administrative review of Joint Commission'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 the Joint Commission's CAH accreditation
standards to our current Medicare CAH conditions for participation;
and,
A documentation review of the Joint Commission's survey
processes to:
[cir] Determine the composition of the survey team, surveyor
qualifications, and the ability of the Joint Commission to provide
continuing surveyor training;
[cir] 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;
[cir] Evaluate the Joint Commission's procedures for monitoring
providers or suppliers found to be out of compliance with the Joint
Commission program requirements. The monitoring procedures are used
only when the Joint Commission identifies noncompliance. If
noncompliance is identified through validation reviews, the survey
agency monitors corrections as specified at Sec. 488.7(d);
[cir] 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;
[cir] 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;
[cir] Determine the adequacy of staff and other resources;
[cir] Review the Joint Commission's ability to provide adequate
funding for performing required surveys;
[cir] Confirm the Joint Commission's policies with respect to
whether surveys are announced or unannounced; and,
[cir] 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 23,
2008 proposed notice (73 FR 30107) also solicited public comments
regarding whether the Joint Commission's requirements met or exceeded
the Medicare conditions of participation (CoPs) for CAHs. We received
one public comment in response to our proposed notice.
Comment: This commenter expressed serious concerns related to the
Joint Commission statutory deeming authority for hospitals set forth in
1865(a) of the Social Security Act. This commenter contends that the
Joint Commission's special deeming authority for hospitals has led to a
significant decline in hospital quality.
Response: On July 15, 2008, Congress enacted MIPPA. Section 125 of
this Act revoked the Joint Commission's previously unique irrevocable
statutory deeming authority for hospitals, and includes a 24-month
transition period. Effective July 15, 2010, the Secretary may recognize
the Joint Commission as a national accreditation body for hospitals
based on terms and conditions, and upon submission of such information,
as the Secretary may require. In order to be considered for approval as
a nationally recognized accreditation program for hospitals, the Joint
Commission will have to submit an application in accordance with our
requirements at Sec. 488.4, so that we can ensure that their
requirements for hospital accreditation meet or exceed those of
Medicare's. The Joint Commission's hospital program will be subject to
the same initial and periodic CMS review as all other accreditation
organization's deemed programs. However, we note that the Joint
Commission has always been required by section 1865(b) of the Act (now
section 1865(a)) to apply for deeming authority for CAHs, subject to
the same terms and conditions as all other national accrediting
organizations. Consequently, we note that the commenter's observations
are not directly related to this application for continued deeming
authority for CAHs. The Joint Commission last was granted recognition
as an approved accreditation organization for CAHs for a six year term
effective November 21, 2002 (67 FR 54657, August 23, 2002).
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 accreditation requirements and
survey process with the Medicare CAH CoPs
[[Page 63482]]
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:
The Joint Commission amended their policies to eliminate
the use of supplemental findings. All survey findings will be
identified as a requirement for improvement, and will, therefore,
require resolution through the evidence of standards compliance
process;
The Joint Commission modified its evidence of standards
compliance process (ESC) to ensure that accepted ESCs contain the
critical information necessary to provide assurance that an identified
deficiency had been adequately corrected;
The Joint Commission modified its survey report to clearly
identify whether an identified deficient practice represented
condition-level noncompliance or standard-level noncompliance;
The Joint Commission developed and conducted training on
the CMS documentation requirements for its surveyors to ensure that
issues cited would provide a clear and detailed description of the
deficient practice and relevant finding;
The Joint Commission modified its policies regarding
complaint investigation activities to comply with the requirements at
Sec. 488.4(a)(6) and chapter five of the SOM;
To meet the Medicare requirements related to unannounced
surveys at 2700A of the SOM, the Joint Commission modified its
electronic application process to no longer allow the CAH to indicate
``avoid dates'' or ``a ready month'' in which organizations could
receive an accreditation survey for deemed status;
The Joint Commission revised its accreditation decision
letters to ensure they are accurate and contain all the required
elements necessary for the CMS Regional Office to render a decision
regarding deemed status of a CAH;
The Joint Commission modified its policies regarding
condition-level noncompliance identified during an initial
certification survey for participation in Medicare in accordance with
section 2005A of the SOM;
The Joint Commission added language to its standards, and
interpretive guidance to address the requirements at Sec. 485.610(e)
(off-campus and co-location requirements) and Sec. 485.635(e)
(rehabilitation therapy services);
To meet the Medicare requirements at Sec. 485.616(a)
(agreements with network hospitals), the Joint Commission amended its
standards to include a requirement for CAHs that are part of a rural
health network to have an agreement with at least one hospital;
To meet the Medicare requirements at Sec. 485.618(c)(2)
(blood storage facilities) and Sec. 485.635(c)(4)(i) (contractual and
arranged services), the Joint Commission amended its standards to
clarify that the governing body must approve all services provided at
the CAH through contractual agreements;
To meet the Medicare requirements at Sec. 485.623(b)(5),
the Joint Commission revised several of its elements of performance
(EP) to address the ventilation, lighting, and temperature control in
pharmaceutical, patient care, and food preparation areas;
To meet the Medicare requirements at Sec. 485.623(c)(1),
the Joint Commission modified its standards and EPs to address training
of staff on handling emergencies;
To meet the Medicare requirements at Sec. 485.623(d)(3),
the Joint Commission added language to the appendix of the CAH manual
to clarify the provision of waivers related to life safety code (LSC);
To meet the Medicare requirements at Sec. 485.623(d)(4),
the Joint Commission added an EP to address the requirement that the
CAH must maintain written evidence of regular inspection and approval
by state and local fire control agencies;
To meet the Medicare requirements at Sec. 485.623(d)(7),
the Joint Commission amended its crosswalk to include language related
to requirements of alcohol-based hand rubs;
The Joint Commission added language to its standards to
address the requirements at Sec. 485.627(b) (disclosure of ownership
and control);
To meet the Medicare requirements at Sec. 485.635(d)(2),
the Joint Commission added language to its standards to address the
requirements related to the physician assistants (specifically,
supervision and evaluation of nursing care);
To meet the Medicare requirements at Sec. 485.639(c), the
Joint Commission added language to its standards to address who may
administer anesthesia;
To meet the Medicare requirements of Sec. 12.25(e), the
Joint Commission added language to the CAH manual that states that CAHs
are not permitted to have satellite facilities;
To meet the Medicare requirements at Sec. 412.27(a), the
Joint Commission added language to its standards to include provisions
related to admission of psychiatric patients;
To meet the Medicare requirements at Sec. 412.27(c)(4),
the Joint Commission added language to its standards to address the
requirements related to progress notes;
To meet the Medicare requirements at Sec. 412.27(d)(5),
the Joint Commission added language to its standards to address the
responsibilities of the social work staff;
To address the requirement that a doctor manage or
coordinate a patient's general medical condition at Sec. 482.12(c)(4),
the Joint Commission added language to its standards for a distinct
part unit(s) (DPU);
To address the requirements related to budget and capital
expenditures at Sec. 482.12(d)(2)-(5), the Joint Commission added
language to its standards for DPUs;
To address the requirements related to the governing
body's responsibility to review and resolve grievances at Sec.
482.13(a)(2), the Joint Commission added language to its standards for
DPUs;
To address the requirements of the patient's right to
access records at Sec. 482.13(d)(2), the Joint Commission added
language to the standards for DPUs;
To address the requirements related to duties and
privileges of the medical staff at Sec. 482.22(c)(2), the Joint
Commission added language to its standards for DPUs;
To address the requirements related to autopsies at Sec.
482.22(d), the Joint Commission added language to its standards for
DPUs; and,
To address the requirements related to the availability of
a registered nurse at Sec. 482.23(b), the Joint Commission added
language to its standards for DPUs.
Since the Joint Commission's last application for deeming authority
for CAHs in 2002, CMS revised the CAH requirements August 11, 2004 (60
FR 49272) to include a new condition at Sec. 485.647. This condition
of participation outlines the eligibility requirements for CAHs that
wish to have a DPU. Under this condition, a CAH can provide inpatient
psychiatric or rehabilitation services in a DPU so long as the services
furnished in this DPU comply with the hospital requirements specified
at Sec. 482, the requirements for excluded hospital units at Sec.
412.25, and the additional requirements at Sec. 412.27 for excluded
psychiatric units; and Sec. Sec. 412.29 and 412.30 for excluded
rehabilitation units.
As a result, the Joint Commission had to address all of the DPU
requirements
[[Page 63483]]
at Sec. 485.647, including a crosswalk addressing the Medicare
hospital CoPs at Sec. 482, as part of its application for renewal of
CAH deeming authority. Given the Joint Commission's unique statutory
deeming authority for hospitals as set forth in former section 1865(a)
of the Act, the Joint Commission had previously not been subject to a
comparability review of its hospital accreditation program in
accordance with the requirements at Sec. Sec. 488.4 and 488.8. Review
of the Joint Commission revised accreditation standards for hospitals
revealed that significant gaps remain between the Joint Commission
standards and the Medicare hospital CoPs.
In accordance with Sec. 488.8(d)(3), every six years, or sooner as
determined by CMS, an approved accreditation organization must reapply
for continued approval of deeming authority. CMS notifies the
organization of the materials the organization must submit as part of
the reapplication procedure. An accreditation organization that is not
meeting the requirements of this subpart, as determined through a
comparability review, must furnish CMS, upon request and at any time,
with the reapplication materials CMS requests. CMS will establish a
deadline by which the materials are to be submitted.
In accordance with Sec. 488.8(f)(3)(i), if we determine that an AO
has failed to adopt requirements comparable to CMS requirements, we may
grant a conditional approval of the AO's deeming authority for a period
of up to 180 days to adopt comparable requirements. Within 60 days
after the end of this period, CMS will make a final determination as to
whether or not the Joint Commission's CAH accreditation requirements
are comparable to CMS requirements and issue an appropriate notice that
includes reasons for our determination no later than July 19, 2009. If
the Joint Commission has not made improvements acceptable to CMS during
this period, CMS may remove recognition of deemed authority for its CAH
program effective up to 30 days from the date we provide written notice
to the Joint Commission that its CAH deeming authority will be removed.
In addition, because of our concern about DPU standards, once the Joint
Commission has implemented their revised CAH DPU standards, we will
conduct a survey observation at the next available opportunity to
validate proper application of the standards.
B. Term of Approval
Based on the review and observations described in section III of
this final notice, specifically remaining significant gaps between the
Joint Commission hospital standards for DPUs and Medicare hospital
CoPs. We have determined that the Joint Commission's accreditation
standards for CAH DPUs require further revision and subsequent review.
We are confident that with additional time, the Joint Commission will
make the necessary revisions to their DPU standards and implement these
revised standards to ensure that the Joint Commission's accreditation
program for CAH DPUs meets or exceeds the Medicare requirements as
stated at Sec. 485. Therefore, we conditionally approve the Joint
Commission as a national accreditation organization for CAHs that
request participation in the Medicare program, effective November 21,
2008 through November 21, 2011, with a 180 day probationary period
through May 20, 2009.
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: September 11, 2008.
Kerry Weems,
Acting Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. E8-25193 Filed 10-23-08; 8:45 am]
BILLING CODE 4120-01-P