[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:
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.
The comparison of DNV GL's Medicare hospital accreditation
program standards to our current Medicare hospitals Conditions of
Participation (CoPs).
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:
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.''
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.
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.
Section 488.5(a)(11)(ii), to ensure that the data
submitted in to CMS is timely, complete and accurate.
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.
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).
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.
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.
Section 488.28(d), to ensure that all corrective action
plans contain an expected correction completion date, consistent with
CMS requirements.
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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