[Federal Register Volume 77, Number 165 (Friday, August 24, 2012)]
[Notices]
[Pages 51537-51539]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-20199]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-3258-FN]


Medicare and Medicaid Programs; Continued Approval of Det Norske 
Veritas Healthcare's (DNVHC's) Hospital Accreditation Program

AGENCY: Centers for Medicare and Medicaid Services, HHS.

ACTION: Final notice.

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SUMMARY: This final notice announces our decision to approve the Det 
Norske Veritas Healthcare (DNVHC) for continued recognition as a 
national accrediting organization for hospitals that wish to 
participate in the Medicare or Medicaid programs. A hospital that 
participates in Medicaid must also meet the Medicare conditions of 
participation as referenced in 42 CFR 488.5(3)(b) and 42 CFR 488.6(b). 
This approval is effective September 26, 2012, through September 26, 
2018.

DATES: This final notice is effective September 26, 2012, through 
September 26, 2018.

FOR FURTHER INFORMATION CONTACT: Barbara Easterling, (410) 786-0482; 
Cindy Melanson, (410) 786-0310; or Patricia Chmielewski, (410) 786-
6899.

SUPPLEMENTARY INFORMATION:

I. Background

    Under the Medicare program, eligible beneficiaries may receive 
covered services in a hospital provided certain requirements are met. 
Section 1861(e) of the Social Security Act (the Act) establishes 
distinct criteria for facilities seeking designation as a hospital. 
Regulations concerning provider agreements are at 42 CFR part 489 and 
those pertaining to activities relating to the survey and certification 
of facilities are at part 488. The regulations at part 482 specify the 
conditions that a hospital must meet to participate in the Medicare 
program, the scope of covered services and the conditions for Medicare 
payment for hospitals.
    Generally, to enter into an agreement, a hospital must first be 
certified by a state survey agency as complying with the conditions or 
requirements set forth in part 482. Thereafter, the hospital is subject 
to regular surveys by a state survey agency to determine whether it 
continues to meet these requirements. However, there is an alternative 
to surveys by state agencies. Certification by a nationally recognized 
accreditation program can substitute for ongoing state review.

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    Section 1865(a)(1) of the Act provides that, if a provider entity 
demonstrates through accreditation by an approved national accrediting 
organization (AO) that all applicable Medicare conditions are met or 
exceeded, we will deem those provider entities as having met the 
requirements. Accreditation by an accrediting organization is voluntary 
and is not required for Medicare participation.
    If an accrediting organization is recognized by the Secretary of 
the Department of Health and Human Services as having standards for 
accreditation that meet or exceed Medicare requirements, any provider 
entity accredited by the national accrediting body's approved program 
would be deemed to have met the Medicare conditions. A national 
accrediting organization applying for approval of its accreditation 
program under part 488, subpart A, must provide us with reasonable 
assurance that the accrediting organization requires the accredited 
provider entities to meet requirements that are at least as stringent 
as the Medicare conditions. Our regulations concerning the approval of 
accrediting organizations are set forth at Sec.  488.4 and Sec.  
488.8(d)(3). The regulations at Sec.  488.8(d)(3) require accrediting 
organizations to reapply for continued approval of its accreditation 
program every 6 years or sooner as determined by us.
    Det Norske Veritas Healthcare's current term of approval for their 
hospital accreditation program expires September 26, 2012.

II. Application Approval Process

    Section 1865(a)(3)(A) of the Act provides a statutory timetable to 
ensure that our review of applications for CMS-approval of an 
accreditation program is conducted in a timely manner. The statute 
provides CMS 210 days after the date of receipt of a complete 
application, with any documentation necessary to make the 
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 
accrediting 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

    In the March 23, 2012 Federal Register (77 FR 17070), we published 
a proposed notice in the announcing DNVHC's request for approval of its 
hospital accreditation program. In the March 23, 2012 proposed notice, 
we detailed our evaluation criteria. Under section 1865(a)(2) of the 
Act and in our regulations at Sec.  488.4 and Sec.  488.8, we conducted 
a review of DNVHC'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 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.
     The comparison of DNVHC's accreditation to our current 
Medicare hospital conditions of participation.
     A documentation review of DNVHC's survey process to 
determine the following:
    + Determine the composition of the survey team, surveyor 
qualifications, and DNVHC's ability to provide continuing surveyor 
training.
    + 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.
    + Evaluate DNVHC's procedures for monitoring hospitals out of 
compliance with DNVHC's 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).
    + Assess DNVHC's ability to report deficiencies to the surveyed 
facilities and respond to the facility's plan of correction in a timely 
manner.
    + Establish DNVHC's ability to provide us with electronic data and 
reports necessary for effective validation and assessment of the 
organization's survey process.
    + Determine the adequacy of staff and other resources.
    + Confirm DNVHC's ability to provide adequate funding for 
performing required surveys.
    + Confirm DNVHC's policies with respect to whether surveys are 
announced or unannounced.
    + 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 section 1865(a)(3)(A) of the Act, the March 23, 
2012 proposed notice also solicited public comments regarding whether 
DNVHC's requirements met or exceeded the Medicare conditions of 
participation for hospitals. We received two comments in response to 
our proposed notice. The commenters expressed continued support for 
DNVHC's hospital accreditation program. In addition, the commenters 
stated DNVHC's standards are closely aligned with the hospital 
conditions of participation, thus allowing hospitals to be in 
compliance with the Medicare requirements.

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 requirements and survey process with 
the Medicare conditions of participation and survey process as outlined 
in the State Operations Manual (SOM). Our review and evaluation of 
DNVHC's hospital application, which were conducted as described in 
section III. of this final notice, yielded the following:
     To meet the requirements at Sec.  482.13(a), DNVHC revised 
its standards to include language to address the hospital's 
responsibility to protect and promote each patient's rights.
     To meet the requirements at Sec.  482.13(a)(2), DNVHC 
revised its standards to require prompt resolution of patient 
grievances.
     To meet the requirements at Sec.  482.13(b)(3), DNVHC 
revised its standards to include the requirements at Sec.  489.100, 
Sec.  489.102, Sec.  489.104 regarding advanced directive.
     To meet the requirements at Sec.  482.52(b), DNVHC revised 
its standards to ensure anesthesia services are consistent with the 
needs and resources of the hospital.
     To meet the requirements at Sec.  489.13, DNVHC modified 
its policies related to the accreditation effective date.
     To meet the survey process requirements in Appendix A of 
the SOM, DNVHC revised its policy outlining the minimum number of 
inpatient records required for review during an accreditation survey.
     To meet the requirements at Sec.  488.4, DNVHC revised its 
policies to require a copy of the surveyor's annual evaluation be 
included in the surveyor's file.
     DNVHC revised its complaint policies to ensure all 
complaint investigations are conducted in

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accordance with the requirements at SOM chapter five.
     DNVHC revised its policies and procedures to clarify that 
they do not have authority to advise facilities regarding certification 
issues. Instead, DNVHC must contact the CMS Regional Office on facility 
specific certification issues for consultation and direction.

B. Term of Approval

    Based on our 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 DVNHC 
as a national accreditation organization for hospitals that request 
participation in the Medicare program, effective September 26, 2012, 
through September 26, 2018.

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--Supplementary Medical Insurance 
Program)

    Dated: August 9, 2012.
Marilyn Tavenner,
Acting Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2012-20199 Filed 8-23-12; 8:45 am]
BILLING CODE 4120-01-P