Medicare and Medicaid Programs; Approval of Det Norske Veritas Healthcare, Inc. for Deeming Authority for Hospitals, 56588-56590 [E8-22585]
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56588
Federal Register / Vol. 73, No. 189 / Monday, September 29, 2008 / Notices
to lengthy delays due to heightened
security precautions.
The FTC Act and other laws the
Commission administers permit the
collection of public comments to
consider and use in this proceeding as
appropriate. The Commission will
consider all timely and responsive
public comments that it receives,
whether filed in paper or electronic
form. Comments received will be
available to the public on the FTC
website, to the extent practicable, at
www.ftc.gov. As a matter of discretion,
the FTC makes every effort to remove
home contact information for
individuals from the public comments it
receives before placing those comments
on the FTC website. More information,
including routine uses permitted by the
Privacy Act, may be found in the FTC’s
privacy policy at (https://www.ftc.gov/
ftc/privacy.shtm).
FOR FURTHER INFORMATION CONTACT:
Requests for additional information
should be addressed to Jock K. Chung,
Attorney, Division of Enforcement,
Bureau of Consumer Protection, Federal
Trade Commission, NJ-2122, 600
Pennsylvania Avenue, N.W.,
Washington, D.C. 20580, (202) 3262984.
SUPPLEMENTARY INFORMATION: Under the
Paperwork Reduction Act (‘‘PRA’’), 44
U.S.C. 3501-3520, federal agencies must
obtain approval from OMB for each
collection of information they conduct
or sponsor. On June 18, 2008, the FTC
sought comment on the information
collection requirements pertaining to
the Commission’s Amplifier Rule (OMB
Control Number 3084-0105).2 No
comments were received. Pursuant to
the OMB regulations that implement the
PRA (5 CFR Part 1320), the FTC is
providing this second opportunity for
public comment while seeking OMB
approval to extend the existing
paperwork clearance for the
Commission’s Amplifier Rule. All
comments should be filed as prescribed
in the ADDRESSES section above, and
must be received on or before October
29, 2008.
The Amplifier Rule assists consumers
by standardizing the measurement and
disclosure of power output and other
performance characteristics of
amplifiers in stereos and other home
entertainment equipment. The Rule also
specifies the test conditions necessary to
make the disclosures that the Rule
requires.
Estimated annual hours burden: 450
hours (300 testing-related hours; 150
disclosure-related hours).
2
The Rule’s provisions require affected
entities to test the power output of
amplifiers in accordance with a
specified FTC protocol. The
Commission staff estimates that
approximately 300 new amplifiers and
receivers come on the market each year.
High fidelity manufacturers routinely
conduct performance tests on these new
products prior to sale. Because
manufacturers conduct such tests, the
Rule imposes no additional costs except
to the extent that the FTC protocol is
more time-consuming than alternative
testing procedures. In this regard, a
warm-up (‘‘precondition’’) period that
the Rule requires before measurements
are taken may add approximately one
hour to the time testing would
otherwise entail. Thus, staff estimates
that the Rule imposes approximately
300 hours (1 hour x 300 new products)
of added testing burden annually.
In addition, the Rule requires
disclosures if a manufacturer makes a
power output claim for a covered
product in an advertisement,
specification sheet, or product brochure.
This requirement does not impose any
additional costs on manufacturers
because, absent the Rule, media
advertisements, as well as manufacturer
specification sheets and product
brochures, would contain a power
specification obtained using an
alternative to the Rule-required testing
protocol. The Rule, however, also
requires disclosure of harmonic
distortion, power bandwidth, and
impedance ratings in manufacturer
specification sheets and product
brochures that might not otherwise be
included.
Staff assumes that manufacturers
produce one specification sheet and one
brochure each year for each new
amplifier and receiver. The burden of
disclosing the harmonic distortion,
bandwidth, and impedance information
on the specification sheets and
brochures is limited to the time needed
to draft and review the language
pertaining to the aforementioned
specifications. Staff estimates the time
involved for this task to be a maximum
of fifteen minutes for each new
specification sheet and brochure for a
total of 150 hours ([300 new products x
1 specification sheet) + (300 new
products x 1 brochure)] x 15 minutes).
The total annual burden imposed by
the Rule, therefore, is approximately
450 burden hours for testing and
disclosures.
73 FR 34750.
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16:48 Sep 26, 2008
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Estimated annual cost burden:
$19,000, rounded to the nearest
thousand.3
Generally, electronics engineers
perform the testing of amplifiers and
receivers. Staff estimates a labor cost of
$12,300 for such testing (300 hours for
testing x $41 per hour). Staff assumes
advertising or promotions managers
prepare the disclosures contained in
product brochures and manufacturer
specification sheet and estimates a labor
cost of $6,600 (150 hours for disclosures
x $44 per hour). Accordingly, staff
estimates the total labor costs associated
with the Rule to be approximately
$19,000 per year, rounded to the nearest
thousand ($12,300 for testing + $6,600
for disclosures).
The Rule imposes no capital or other
non-labor costs because its requirements
are incidental to testing and advertising
done in the ordinary course of business.
William Blumenthal,
General Counsel.
[FR Doc. E8–22811 Filed 9–26–08: 8:45 am]
[BILLING CODE 6750–01–S]
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
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Final notice.
AGENCY:
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
3 Staff’s labor cost estimates are based on recent
data from the Bureau of Labor and Statistics found
here: (https://www.bls.gov/news.release/pdf/
ocwage.pdf).
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Federal Register / Vol. 73, No. 189 / Monday, September 29, 2008 / Notices
mstockstill on PROD1PC66 with NOTICES
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
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16:48 Sep 26, 2008
Jkt 214001
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 30day 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 § 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 decisionmaking 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:
Æ Determine the composition of the
survey team, surveyor qualifications,
and DNVHC’s ability to provide
continuing surveyor training;
Æ 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;
Æ 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 § 488.7(d);
Æ Assess DNVHC’s ability to report
deficiencies to the surveyed facilities
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Fmt 4703
Sfmt 4703
56589
and respond to the facility’s plan of
correction in a timely manner;
Æ Establish DNVHC’s ability to
provide us with electronic data and
reports necessary for effective validation
and assessment of DNVHC’s survey
process;
Æ Determine the adequacy of staff
and other resources;
Æ Review DNVHC’s ability to
provide adequate funding for
performing required surveys;
Æ Confirm DNVHC’s policies with
respect to whether surveys are
announced or unannounced; and,
Æ 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 § 488.4.
Comment: One commenter stated that
although he agrees with DNVHC’s
premise, he believes that a single,
E:\FR\FM\29SEN1.SGM
29SEN1
56590
Federal Register / Vol. 73, No. 189 / Monday, September 29, 2008 / Notices
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 § 488.4 and § 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
mstockstill on PROD1PC66 with NOTICES
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 § 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
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16:48 Sep 26, 2008
Jkt 214001
all deficiencies cited contain a
regulatory reference, a clear and
detailed description of the deficient
practice and relevant finding;
• In accordance with § 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 § 488.20(a) and § 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
§ 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 § 482.12(f)(2),
§ 482.23(a), and § 482.23(c)(1);
• DNVHC amended its interpretive
guidance and surveyor tools to meet the
requirements at § 482.13(c)(3),
§ 488.22(c)(3), § 482.23(c)(3),
§ 482.24(c)(1)(iii), § 482.25(b)(2)(i),
§ 482.25(b)(6), § 482.25(b)(7),
§ 482.30(b)(3)(i), § 482.43(e),
§ 482.45(a)(1), § 482.51(a), § 482.52,
§ 482.53(b), § 482.54, § 482.54(a), and
§ 482.56;
• DNVHC added language to its
standards, and interpretive guidance to
address the requirements at
§ 482.13(e)(9), § 482.30, and
§ 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 § 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
PO 00000
Frm 00050
Fmt 4703
Sfmt 4703
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Proposed Information Collection
Activity; Comment Request
Proposed Projects
Title: Child Care and Development
Fund Plan for States/Territories for FFY
2010–2011 (ACF–118).
OMB No.: 0970–0114.
Description: The Child Care and
Development Fund (CCDF) Plan (the
Plan) for States and Territories is
required from each CCDF Lead agency
in accordance with Section 658E of the
Child Care and Development Block
Grant Act of 1990, as amended (Pub. L.
101–508, Pub. L. 104–193, and 42 U.S.C.
9858). The implementing regulations for
the statutorily required Plan are set forth
at 45 CFR 98.10 through 98.18. The
Plan, submitted on the ACF–118, is
required biennially, and remains in
effect for two years. The Plan provides
ACF and the public with a description
of, and assurance about, the States or
the Territories child care program. The
ACF–118 is currently approved through
June 30, 2009, making it available to
States and Territories needing to submit
Plan Amendments through the end of
the FY 2009 Plan Period. However, in
July 2009, States and Territories will be
required to submit their FY 2010–2011
E:\FR\FM\29SEN1.SGM
29SEN1
]]>Agencies
[Federal Register Volume 73, Number 189 (Monday, September 29, 2008)]
[Notices]
[Pages 56588-56590]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-22585]
=======================================================================
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
[[Page 56589]]
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,
[[Page 56590]]
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
