[Federal Register: September 29, 2008 (Volume 73, Number 189)]
[Notices]
[Page 56588-56590]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr29se08-83]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-2895-FN]
Medicare and Medicaid Programs; Approval of Det Norske Veritas
Healthcare, Inc. for Deeming Authority for Hospitals
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Final notice.
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SUMMARY: This notice announces our decision to approve Det Norske
Veritas Healthcare, Inc. (DNVHC) for 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 26,
2008 through September 26, 2012.
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
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services in 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 at 42 CFR part
489 and those pertaining to the activities relating to the survey and
certification of facilities are 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 set forth in the statute and part 482 of the regulations.
Then, the hospital is subject to routine surveys by a State survey
agency to determine whether it continues to meet the Medicare
requirements.
There is, however, 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 (as
amended by section 125(a) of the Medicare Improvements for Patients and
Providers Act of 2008, Public Law 110-275, July 15, 2008) (MIPPA))
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
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.
II. Deeming Applications Approval Process
Section 1865(a)(3)(A) of the Act (as amended) provides a statutory
time table 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 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 April 25, 2008, we published a proposed notice in the Federal
Register (73 FR 22420) announcing DNVHC's request for approval as a
deeming organization for hospitals. In the proposed notice, we detailed
our evaluation criteria. Under section 1865(a)(2) of the Act (as
amended) and our regulations at Sec. 488.4 (Application and
reapplication procedures for accreditation organizations), we conducted
a review of DNVHC's application in accordance with the criteria
specified by our regulation, which include, but are not limited to the
following:
An onsite administrative review of DNVHC'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 DNVHC's hospital accreditation standards
to our current Medicare hospital CoPs; and,
A documentation review of DNVHC's survey processes to:
[cir] Determine the composition of the survey team, surveyor
qualifications, and DNVHC's ability to provide continuing surveyor
training;
[cir] Compare DNVHC'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 DNVHC's procedures for monitoring providers or
suppliers found to be out of compliance with DNVHC program
requirements. The monitoring procedures are used only when DNVHC
identifies noncompliance. If noncompliance is identified through
validation reviews, the State survey agency monitors corrections as
specified at Sec. 488.7(d);
[cir] Assess DNVHC's ability to report deficiencies to the
surveyed facilities and respond to the facility's plan of correction in
a timely manner;
[cir] Establish DNVHC's ability to provide us with electronic data
and reports necessary for effective validation and assessment of
DNVHC's survey process;
[cir] Determine the adequacy of staff and other resources;
[cir] Review DNVHC's ability to provide adequate funding for
performing required surveys;
[cir] Confirm DNVHC's policies with respect to whether surveys are
announced or unannounced; and,
[cir] Obtain DNVHC'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 former section 1865(b)(3)(A) of the Act, (now
section 1865(a)(3)(A) of the Act), the April 25, 2008 proposed notice
also solicited public comments regarding whether DNVHC's requirements
met or exceeded the Medicare CoPs for hospitals. We received 33 public
comments in response to our proposed notice.
The majority of commenters expressed support for DNVHC's
application for hospital deeming authority. Many of these commenters
stated that it is important for hospitals to have alternatives for
accreditation. Other commenters specifically voiced support for DNVHC's
integration of the Medicare CoPs and the ISO 9001 quality management
systems. These commenters stated that DNVHC's accreditation program
provides hospitals with a unique, refreshing approach to ensure
compliance with the Medicare requirements and facilitates continuous
improvement.
Comment: One commenter stated that it would be inappropriate to
issue DNVHC exclusive deeming authority to certify hospitals using the
ISO 9001 standards and the Medicare CoPs.
Response: As a CMS approved national accreditation organization,
DNVHC does not have exclusive deeming authority for hospitals based on
a program that integrates the ISO 9001 standards and the Medicare
hospital CoPs. Any accreditation organization that can demonstrate that
its accreditation program meets or exceeds the Medicare requirements
can apply for deeming authority. CMS' application process for deeming
authority is outlined in the Code of Federal Regulations at Sec.
488.4.
Comment: One commenter stated that although he agrees with DNVHC's
premise, he believes that a single,
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standardized, regulatory approach to healthcare is necessary.
Response: The Medicare CoPs are the minimum health and safety
requirements that all hospitals must meet to participate in the
Medicare program and serves as a single, standardized federal
regulatory approach. Accreditation by an accreditation organization is
voluntary and is not required for Medicare participation. A hospital
may opt for routine surveys by a State survey agency to determine
whether it meets the Medicare requirements.
Comment: One commenter stated that it is CMS' responsibility to
review DNVHC's application thoroughly to ensure DNVHC will meet the
intent of the regulations. This commenter also expressed concerns
related to a potential conflict of interest issue as DNVHC currently
provides Joint Commission readiness consulting services to prepare
hospitals for a Joint Commission accreditation survey.
Response: All deeming applications are reviewed in accordance with
the requirements at Sec. 488.4 and Sec. 488.8 to ensure that the
applicant's accreditation program meets or exceeds Medicare's
requirements. In terms of the conflict of interest issue raised by the
commenter, DNVHC has provided a written statement as part of its
application that this consultative service will be discontinued when
DNVHC is approved as a nationally recognized accreditation organization
for hospitals.
IV. Provisions of the Final Notice
A. Differences Between DNVHC's Standards and Requirements for
Accreditation and Medicare's Conditions and Survey Requirements
We compared DNVHC's hospital accreditation requirements and survey
process with the Medicare hospital CoPs and survey process as outlined
in the State Operations Manual (SOM). Our review and evaluation of
DNVHC's deeming application, which were conducted as described in
section III of this final notice, yielded the following:
DNVHC modified its policies related to the effective date
of participation in Medicare for new providers in accordance with
requirements at Sec. 489.13;
DNVHC modified its policies regarding time frames for
sending and receiving a required plan of correction, and the required
elements of an approved plan of correction in accordance with section
2728 of the SOM;
DNVHC developed and conducted training for its surveyors
to ensure that all deficiencies cited contain a regulatory reference, a
clear and detailed description of the deficient practice and relevant
finding;
In accordance with Sec. 488.3(a) and Appendix A of the
SOM, DNVHC modified its policies to ensure that all off-campus provider
based locations, satellite locations and services provided at remote
locations that are under the hospital's CCN number will be surveyed at
least once every three years;
To meet the Medicare requirements at Sec. 488.20(a) and
Sec. 488.28(a), DNVHC developed a policy regarding our requirements
for submission of a plan of correction by the hospital and the
completion of an onsite follow-up survey to determine compliance with
Medicare CoPs after citing condition level noncompliance during a
recertification survey;
DNVHC developed a policy regarding condition level
noncompliance identified during an initial certification survey for
participation in Medicare in accordance with section 2005A2 of the SOM;
DNVHC modified its policies regarding complaint
investigation activities with appropriate licensing bodies and
ombudsmen programs in accordance with the requirements at Sec.
488.4(a)(6);
DNVHC amended its interpretive guidance and surveyor tool
to include the survey methods its surveyors would use to determine
compliance with the requirements at Sec. 482.12(f)(2), Sec.
482.23(a), and Sec. 482.23(c)(1);
DNVHC amended its interpretive guidance and surveyor tools
to meet the requirements at Sec. 482.13(c)(3), Sec. 488.22(c)(3),
Sec. 482.23(c)(3), Sec. 482.24(c)(1)(iii), Sec. 482.25(b)(2)(i),
Sec. 482.25(b)(6), Sec. 482.25(b)(7), Sec. 482.30(b)(3)(i), Sec.
482.43(e), Sec. 482.45(a)(1), Sec. 482.51(a), Sec. 482.52, Sec.
482.53(b), Sec. 482.54, Sec. 482.54(a), and Sec. 482.56;
DNVHC added language to its standards, and interpretive
guidance to address the requirements at Sec. 482.13(e)(9), Sec.
482.30, and Sec. 482.30(b)(1)(ii)(A)-(B);
DNVHC amended its policies by eliminating recommendations
referred to as ``opportunities for improvement'' from the written
survey findings to meet the requirements at Sec. 488.28(a) and Section
2726 of the SOM.
B. Term of Approval
Based on the review and observations described in section III of
this final notice, we have determined that DNVHC's requirements for
hospitals meet or exceed our requirements. Therefore, we approve DNVHC
as a national accreditation organization for hospitals that request
participation in the Medicare program, effective September 26, 2008
through September 26, 2012.
V. Collection of Information Requirements
This document does not impose information collection and record
keeping 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: August 21, 2008.
Kerry Weems,
Acting Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. E8-22585 Filed 9-25-08; 11:15 am]
BILLING CODE 4120-01-P