[Federal Register Volume 73, Number 189 (Monday, September 29, 2008)]
[Notices]
[Pages 56588-56590]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-22585]


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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:
    <bullet> 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;
    <bullet> A comparison of DNVHC's hospital accreditation standards 
to our current Medicare hospital CoPs; and,
    <bullet> 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:
    <bullet> DNVHC modified its policies related to the effective date 
of participation in Medicare for new providers in accordance with 
requirements at Sec.  489.13;
    <bullet> 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;
    <bullet> 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;
    <bullet> 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;
    <bullet> 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;
    <bullet> 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;
    <bullet> 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);
    <bullet> 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);
    <bullet> 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;
    <bullet> 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);
    <bullet> 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