[Federal Register Volume 83, Number 160 (Friday, August 17, 2018)]
[Notices]
[Pages 41073-41075]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-17815]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-3357-FN]


Medicare and Medicaid Program; Application From DNV GL--
Healthcare (DNV GL) for Continued Approval of Its Hospital 
Accreditation Program

AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.

ACTION: Final notice.

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SUMMARY: This final notice announces our decision to approve the DNV 
GL-- Healthcare for continued recognition as a national accrediting 
organization for hospitals that wish to participate in the Medicare or 
Medicaid programs.

DATES: This decision is effective August 17, 2018 through September 26, 
2022.

FOR FURTHER INFORMATION CONTACT:  Karena Meushaw (410) 786-6609, or 
Monda Shaver (410) 786-3410.

SUPPLEMENTARY INFORMATION: 

I. Background

    Under the Medicare program, eligible beneficiaries may receive 
covered services from a hospital, provided that 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 42 CFR part 488. The regulations at 
42 CFR part 482 specify the minimum conditions that a hospital must 
meet to participate in the Medicare program.
    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 of our regulations. Thereafter, the 
hospital is subject to regular surveys by a State survey agency to 
determine whether it continues to meet these requirements. There is an 
alternative, however, to surveys by State agencies.
    Section 1865(a)(1) of the Act provides that, if a provider entity 
demonstrates through accreditation by an approved national accrediting 
organization that all applicable Medicare conditions are met or 
exceeded, we may 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 
may be deemed to meet the Medicare conditions. A national accrediting 
organization applying for approval of its accreditation program under 
part 488, subpart A, must provide the Centers for Medicare and Medicaid 
Services (CMS) 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.  488.5. The regulations at Sec.  488.5(e)(2)(i) 
require accrediting organizations to reapply for continued approval of 
its accreditation program

[[Page 41074]]

every 6 years or sooner as determined by CMS. DNV GL's current term of 
approval for their hospital accreditation program expires September 26, 
2018.

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 Act provides 
us 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 April 17, 2018 Federal Register (83 FR 16862), we published 
a proposed notice announcing DNV GL's request for continued approval of 
its Medicare hospital accreditation program. In the proposed notice, we 
detailed our evaluation criteria. Under section 1865(a)(2) of the Act 
and in our regulations at Sec.  488.5, we conducted a review of DNV 
GL's Medicare hospital accreditation renewal application in accordance 
with the criteria specified by our regulations, which include, but are 
not limited to the following:
    <bullet> An onsite administrative review of DNV GL's: (1) Corporate 
policies; (2) financial and human resources available to accomplish the 
proposed surveys; (3) procedures for training, monitoring, and 
evaluation of its hospital surveyors; (4) ability to investigate and 
respond appropriately to complaints against accredited hospitals; and, 
(5) survey review and decision-making process for accreditation.
    <bullet> The comparison of DNV GL's Medicare hospital accreditation 
program standards to our current Medicare hospitals Conditions of 
Participation (CoPs).
    <bullet> A documentation review of hospital's survey process to:
    ++ Determine the composition of the survey team, surveyor 
qualifications, and DNV GL's ability to provide continuing surveyor 
training.
    ++ Compare DNV GL's processes to those we require of state survey 
agencies, including periodic resurvey and the ability to investigate 
and respond appropriately to complaints against accredited hospitals.
    ++ Evaluate DNV GL's procedures for monitoring hospitals it has 
found to be out of compliance with DNV GL's program requirements. (This 
pertains only to monitoring procedures when DNV GL identifies non-
compliance. If noncompliance is identified by a state survey agency 
through a validation survey, the state survey agency monitors 
corrections as specified at Sec.  488.9(c)).
    ++ Assess DNV GL's ability to report deficiencies to the surveyed 
hospital and respond to the hospital's plan of correction in a timely 
manner.
    ++ Establish DNV GL'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 DNV GL's staff and other resources.
    ++ Confirm DNV GL's ability to provide adequate funding for 
performing required surveys.
    ++ Confirm DNV GL's policies with respect to surveys being 
unannounced.
    ++ Obtain DNV GL'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 April 17, 
2018 proposed notice also solicited public comments regarding whether 
DNV GL's requirements met or exceeded the Medicare CoPs for hospitals. 
We received two comments in response to our proposed notice. All of the 
comments received expressed unanimous support for DNV GL's hospital 
accreditation program.

IV. Provisions of the Final Notice

A. Differences Between DNV GL's Standards and Requirements for 
Accreditation and Medicare Conditions and Survey Requirements

    We compared DNV GL's hospital accreditation program requirements 
and survey process with the Medicare CoPs at 42 CFR part 482, and the 
survey and certification process requirements of Parts 488 and 489. Our 
review and evaluation of DNV GL's hospital application, which were 
conducted as described in section III of this final notice, yielded the 
following areas where, as of the date of this notice, DNV GL has 
revised its standards and certification processes in order to meet the 
requirements at:
    <bullet> Section 482.11 through 482.58, to ensure its standards 
replace the use of the word ``shall'' to ``must'' in all situations 
where CMS regulations use the word ``must'' or, clarify in DNV's 
glossary the intended definition of the word ``shall'' means ``must.''
    <bullet> State Operations Manual, Section 3012, to ensure that DNV 
GL's policies related to the timeframe(s) for follow-up activities, 
including follow-up surveys, for facilities that have previously 
demonstrated non-compliance at the condition level.
    <bullet> Section 488.5(a)(4)(iv), to ensure that the hospital and 
provider-based locations (or a sample when allowed) are included in the 
hospital survey and deficiencies cited under the appropriate CoPs.
    <bullet> Section 488.5(a)(11)(ii), to ensure that the data 
submitted in to CMS is timely, complete and accurate.
    <bullet> Section 488.5(a)(12), to ensure a clearly defined 
complaint investigation process is in place that meets the requirements 
in the State Operations Manual Chapter 5 Section 5010 and Chapter 5 
Section 5075.2 that includes the following:
    ++ Complete and accurate tracking of complaints as well as a 
process for maintaining a documented record of contacts made (for 
example, phone, email and United States mail) with the complainant, and 
others, if applicable;
    ++ Define the number of contact attempts required before closing 
out a complaint, if the complainant does not respond;
    ++ Educate DNV GL complaint intake staff that when complaint 
allegations could potentially result in condition-level non-compliance 
affecting the health and safety of patients, a survey is to be 
considered regardless if the allegation also involves payment related 
allegations; and,
    ++ The complaint must be investigated onsite within an appropriate 
timeframe.
    <bullet> Section 488.26(b), to ensure that DNV GL survey 
documentation includes a detailed deficiency statement that clearly 
supports the manner and degree of non-compliance and that all observed 
non-compliance is cited at the appropriate level (condition verses 
standard level).
    <bullet> Section 488.26(c)(4), to ensure that DNV GL surveyors 
review a sufficient number of inpatient and outpatient medical records 
during the survey process; the appropriate number of documents, logs, 
personnel and credentialing files are reviewed during the survey 
process; the document sources are clearly identified in the survey 
file; and that DNV GL surveyors have been appropriately trained and 
determined by DNV GL to be competent in identifying Immediate Jeopardy 
(IJ)

[[Page 41075]]

situations and appropriateness of facility actions to mitigate IJ risk 
factors prior to the exit of the survey team.
    <bullet> Section 488.28(a), to ensure that the corrective action 
plan submitted by hospitals fully addresses the deficiencies cited and 
that the hospital's corrective actions are hospital wide and not 
focused solely on the area in which the deficiency was identified.
    <bullet> Section 488.28(d), to ensure that all corrective action 
plans contain an expected correction completion date, consistent with 
CMS requirements.
    <bullet> Section 488.18(a), to ensure all observations of non-
compliance are adequately documented in the survey report and ensure 
corrective action is required by the hospital.

B. Term of Approval

    Based on our review and observations described in section III of 
this final notice, we approve DNV GL as a national accreditation 
organization for hospitals that request participation in the Medicare 
program, effective August 17, 2018 through September 26, 2022.
    To verify DNV GL's continued compliance with the provisions of this 
final notice, CMS will conduct a follow-up corporate on-site visit and 
survey observation within 18 months of the publication date of this 
notice.

V. Collection of Information Requirements

    This document does not impose information collection requirements, 
that is, reporting, recordkeeping or third-party disclosure 
requirements. Consequently, there is no need for review by the Office 
of Management and Budget under the authority of the Paperwork Reduction 
Act of 1995 (44 U.S.C. 3501 et seq.).

    Dated: August 6, 2018.
Seema Verma,
Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2018-17815 Filed 8-16-18; 8:45 am]
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