[Federal Register Volume 79, Number 225 (Friday, November 21, 2014)]
[Notices]
[Pages 69482-69486]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-27576]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-3301-FN]
Medicare and Medicaid Programs; Continued Approval of DNV GL--
Healthcare (DNV GL) Critical Access Hospital (CAH) Accreditation
Program
AGENCY: Centers for Medicare & Medicaid Services, HHS.
[[Page 69483]]
ACTION: Final notice.
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SUMMARY: This final notice announces our decision to approve DNV GL--
Healthcare (DNV GL) \1\ for continued recognition as a national
accrediting organization (AO) for critical access hospitals (CAH) that
wish to participate in the Medicare or Medicaid programs.
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\1\ Formerly known as Det Norske Veritas Healthcare, Inc.
(DNVHC).
DATES: This final notice is effective December 23, 2014 through
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December 23, 2020.
FOR FURTHER INFORMATION CONTACT: Barbara Easterling, (410) 786-0482,
Lillian Williams, 410-786-8636, 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 Critical Access Hospital (CAH) provided certain
requirements are met. Sections 1820(c)(2)B, 1820(e) and 1861(mm)(1) of
the Social Security Act (the Act) establish distinct criteria for
facilities seeking designation as a CAH. 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 485, subpart F,
specify the conditions that a CAH must meet to participate in the
Medicare program, the scope of covered services, and the conditions for
Medicare payment for CAHs.
Generally, to enter into an agreement, a CAH must first be
certified by a state survey agency as complying with the conditions or
requirements set forth in part 485, subpart F. Thereafter, the CAH 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.
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 AO 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 AO applying
for approval of its accreditation program under part 488, subpart A,
must provide us with reasonable assurance that the AO requires the
accredited provider entities to meet requirements that are at least as
stringent as the Medicare conditions.
Our regulations concerning the approval of AOs are set forth at
Sec. 488.4 and Sec. 488.8(d)(3). The regulations at Sec. 488.8(d)(3)
require an AO to reapply for continued approval of its accreditation
program every 6 years or sooner as determined by us. The DNV GL's
current term of approval for their CAH accreditation program expires
December 23, 2014.
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 with 210 calendar 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
On June 27, 2014, we published a proposed notice in the Federal
Register (79 FR 36521) announcing DNV GL's request for approval of its
CAH 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. 488.4 and Sec. 488.8, we conducted a review of
DNV GL'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 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 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 DNV GL's accreditation to our current
Medicare CAH conditions of participation (CoPs).
A documentation review of DNV GL'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 of state survey agencies,
including survey frequency, and the ability to investigate and respond
appropriately to complaints against accredited facilities.
++ Evaluate DNV GL's procedures for monitoring CAHs out of
compliance with DNV GL's program requirements. The monitoring
procedures are used only when DNV GL identifies noncompliance. If
noncompliance is identified through validation reviews, the state
survey agency monitors corrections as specified at Sec. 488.7(d).
++ Assess DNV GL's ability to report deficiencies to the surveyed
facilities and respond to the facility'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 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 whether surveys are
announced or 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 June 27,
2014 proposed notice also solicited public comments regarding whether
DNV GL's requirements met or exceeded the Medicare conditions of
participation for CAHs. We received no comments in response to our
proposed notice.
IV. Provisions of the Final Notice
A. Differences Between DNV GL's Standards and Requirements for
Accreditation and Medicare's Conditions and Survey Requirements
We compared DNV GL's CAH 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 DNV
GL's
[[Page 69484]]
CAH accreditation program application, which were conducted as
described in section III of this final notice, yielded the following:
To meet the requirements at Sec. 412.25(d), DNV GL
revised its standards to address the number of excluded units
permitted.
To meet the requirements at Sec. 412.27(c)(2)(vii), DNV
GL revised its standards to include the requirement for an inventory of
the inpatient's assets in a descriptive fashion and ensured that
consistent language is used in the crosswalk and manual.
To meet the requirements at Sec. 412.27(d)(3), DNV GL
revised its standards to more fully address nursing services
requirements.
To meet the requirements Sec. 412.27(d)(4), DNV GL
revised its standards to address ``service objectives'' for
psychological services.
To meet the requirements at Sec. 412.27(d)(6)(ii), DNV GL
revised its standards to address the number of ``qualified therapists,
support personnel and consultants'' needed to provide comprehensive
therapeutic activities consistent with each inpatient's active
treatment program.
To meet the requirements at Sec. 412.29(h), DNV GL
revised its standards to ensure a plan of treatment for each inpatient
that is established, reviewed, and revised as needed by a physician in
consultation with other professional personnel who provide services to
the patient.
To meet the requirements at Sec. 482.12(c)(1)(iv), DNV GL
revised its standards related to a doctor of optometry.
To meet the requirements at Sec. 482.12(c)(2), DNV GL
revised its standards to address the regulatory language, ``patients
are admitted to the hospital only on the recommendation of a licensed
practitioner.''
To meet the requirements at Sec. 482.13(h)(1), DNV GL
revised its standards to more fully address the requirement to inform
each patient (or ``support person, where appropriate'') of his or her
visitation rights, including any clinical restriction or limitation on
such rights, when he or she is informed of his or her rights under this
section, and ensured consistent language is used in its manual and
crosswalk.
To meet the requirements at Sec. 482.21(e)(1), DNV GL
revised its standards to ensure that an ongoing quality assurance
performance improvement program is ``maintained.''
To meet the requirements at Sec. 482.22(c)(5)(i) through
(ii), DNV GL revised its standards to ensure that a medical history and
physical is conducted, completed, and updated in accordance with
``hospital policy.''
To meet the requirements at Sec. 482.25(b)(2)(i), DNV GL
revised its crosswalk to address the requirement that all drugs and
biologicals must be kept in a secure area, and locked when appropriate.
To meet the requirements at Sec. 482.27(b)(3)(i), DNV GL
revised its standards to more fully address the regulatory language
related to HIV testing of blood and blood components from a blood donor
who tested negative at the time of donation, but tests reactive for
evidence of HIV or HCV infection on a later donation, ``or who is at
increased risk for transmitting HIV or HCV infection.''
To meet the requirements at Sec. 482.30(f), DNV GL
revised its crosswalk to address review of professional services.
To meet the requirements at Sec. 482.41(b)(6), DNV GL
revised its standards to include a requirement for the proper routine
storage and prompt disposal of all trash.
To meet the requirements at Sec. 482.41(b)(7), DNV GL
revised its standards to address the evacuation and relocation plan
requirement, periodic instruction for employees and a readily available
plan in the telephone operator's position at the security center.
To meet the requirements at Sec. 483.12(a)(8), DNV GL
revised its standards to address written advance notice of facility
closure.
To meet the requirements at Sec. 483.15(f)(2)(i), DNV GL
revised its standards to address this requirement for a qualified
therapeutic recreational specialist or an activities professional.
To meet the requirements at Sec. 483.15(f)(2)(i), DNV GL
revised its standards to include standards requiring a qualified
therapeutic recreation specialist.
To meet the requirements at Sec. 483.55(a)(1), DNV GL
revised its standards to address the requirement that the facility
provide or obtain from an outside resource, routine and emergency
dental services to meet the needs of each resident.
To meet the requirements at Sec. 485.604(c)(3), DNV GL
revised its standards to include the requirement that physician
assistants must have been assisting primary care physicians for a total
of 12 months during the 18-month period immediately preceding June 25,
1993.
To meet the requirements at Sec. 485.604(b)(3), DNV GL
revised its standards and crosswalk to address the requirement that the
nurse practitioner must have ``been performing an expanded role in the
delivery of primary care for a total of 12 months during the 18-month
period immediately preceding June 25, 1993.''
To meet the requirements at Sec. 485.604(c)(2)(ii), DNV
GL revised its standards to more fully address physician assistant
supervised clinical practice and classroom instruction program
requirements.
To meet the requirements at Sec. 485.606, DNV GL revised
its referenced standard and crosswalk to address how DNV GL determines
that the appropriate CAH designations and certifications have been made
by CMS and/or the state agency.
To meet the requirements at Sec. 485.608, DNV GL revised
its standards to include compliance with federal, state and local CAH
laws and regulations and to reconcile the inconsistent language between
the manual and crosswalk.
To meet the requirements at Sec. 485.608(a), DNV GL
revised its standards to address the requirement that the CAH must be
licensed in accordance with federal ``regulations.''
To meet the requirements at Sec. 485.608(b), DNV GL
revised its standards and crosswalk to address the requirement that all
patient services are furnished in accordance with applicable ``local''
laws, and to address furnishing patient care services in accordance
with state and local ``regulations.''
To meet the requirements at Sec. 485.608(c), DNV GL
revised its standards to address the requirement that the CAH is
licensed in accordance with applicable federal, state, and local
``regulations.''
To meet the requirements at Sec. 485.608(d), DNV GL
revised its standards to address the requirement that staff of the CAH
are ``licensed, certified, or registered in accordance with applicable
federal, state, and local regulations.''
To meet the requirements at Sec. 485.612, DNV GL revised
its standards to ensure the facility is a hospital that has a provider
agreement to participate in the Medicare program as a hospital at the
time the hospital applies for designation as a CAH.
To meet the requirements at Sec. 485.616(a), DNV GL
revised its standards and crosswalk to address agreements with network
hospitals.
To meet the requirements at Sec. 485.616(b), DNV GL
revised its standards and crosswalk to address agreements for
credentialing and quality assurance.
To meet the requirements at Sec. 485.616(c) through
(c)(1)(ii), DNV GL
[[Page 69485]]
revised its standards to address agreements for credentialing and
privileging of telemedicine physicians and practitioners.
To meet the requirements at Sec. 485.616(c)(2)(iv), DNV
GL updated their Medicare cross-walk to include standards to address
when telemedicine services are provided to the CAH's patients through
an agreement with a distant site hospital, the CAH's governing body or
responsible individual may choose to rely upon the credentialing and
privileging decisions of the distant site hospital.
To meet the requirements at Sec. 485.616(c)(3), DNV GL
revised its standards to address the governing body of the CAH must
ensure that telemedicine services are furnished in accordance with
Sec. 485.635(c)(4)(ii) and to ensure consistent language in its
crosswalk.
To meet the requirements at Sec. 485.618(c), DNV GL
revised its standards to address the requirement that the facility
provide blood and blood products, either directly or under arrangement.
To meet the requirements at Sec. 485.618(c)(1), DNV GL
revised its standards to address the requirement that the facility
provide services for the procurement, safekeeping, and transfusion of
blood, including the availability of blood products needed for
emergencies on a 24-hour a day basis.
To meet the requirements at Sec. 485.618(c)(2), DNV GL
revised its standards and crosswalk to address blood storage
facilities.
To meet the requirements at Sec. 485.618(d)(1), DNV GL
revised its standards to address personnel requirements and to ensure
consistent language in its crosswalk.
To meet the requirements at Sec. 485.623, DNV GL revised
its standards to address physical plant and environment and to ensure
consistent language in its crosswalk.
To meet the requirements at Sec. 485.631(b)(1)(ii), DNV
GL revised its standards to address written policies governing services
the CAH furnishes.
To meet the requirements at Sec. 485.631(b)(1)(iii), DNV
GL revised its standards to address the requirement for providing
medical orders.
To meet the requirements at Sec. 485.631(b)(2), DNV GL
revised its standards to address the requirement for providing medical
care services.
To meet the requirements at Sec. 485.631(c)(1)(i), DNV GL
revised its standards to address other CAH non-clinical written
policies.
To meet the requirements at Sec. 485.635(a)(3)(ii), DNV
GL revised its standards to address the requirement for emergency
medical services policies and procedures.
To meet the requirements at Sec. 485.635(a)(3)(iii), DNV
GL revised its standards to address ``the maintenance of health care
records.''
To meet the requirements at Sec. 485.635(a)(3)(iv), DNV
GL revised its standards to address the requirement that current and
accurate records are kept of the receipt and disposition of all
scheduled drugs.
To meet the requirements at Sec. 485.635(b)(1)(ii), DNV
GL revised its standards to clarify how their surveyors determine that
a CAH furnishes acute care inpatient services when no inpatients are
present at the time of the survey.
To meet the requirements at Sec. 485.635(d)(1), DNV GL
revised its standards to clarify under what authority nursing services
may be provided or supervised by a Physician Assistant (PA) where
permitted by state law.
To meet the requirements at Sec. 485.635(d)(4), DNV GL
revised its standards and crosswalk to fully address the requirement
that a nursing care plan must be developed and kept current for each
patient.
To meet the requirements at Sec. 485.638(a)(4), DNV GL
revised its standards to more fully address the requirement that the
CAH maintains a medical record for each patient receiving health care
services.
To meet the requirements at Sec. 485.638(a)(4)(iii), DNV
GL revised its standards to fully address the requirement that the
medical record contains ``reports of treatments and medications.''
To meet the requirements at Sec. 485.639(a), DNV GL
revised its standards to fully address the requirement related to
designation of qualified practitioners allowed to perform surgery ``in
accordance with approved policies and procedures, and with state scope
of practice laws.''
To meet the requirements at Sec. 485.639(b)(2) and
(b)(3), DNV GL revised its standards to address the requirement to
specify a ``qualified'' practitioner examine each patient before
surgery to evaluate the risk of anesthesia.
To meet the requirements at Sec. 485.641(b)(5)(i), DNV GL
revised its standards to fully address the requirement that the CAH
consider the findings of the evaluations, ``including any findings or
recommendations of the Quality Improvement Organization (QIO),'' and
takes corrective action if necessary.
To meet the requirements at Sec. 485.645, DNV GL revised
its standards to explain how it would determine that we have granted
approval for the CAH to provide and be paid for post-hospital SNF level
care as specified in 42 CFR 409.30.
To meet the requirements Sec. 488.28(a) and section 2728B
of the State Operations Manual (SOM), DNV GL amended its policies to
ensure that the accepted PoCs contains the elements comparable to those
specified in the SOM, section 2728B.
To meet the requirements at Sec. 488.6, DNV GL provided a
written plan to address the components of the CAH application for
Distinct Part Units (DPUs) and swing beds, and to ensure that the
surveys consistently document evaluation of the CAH's DPUs and swing
beds, as applicable.
To meet the requirements at Sec. 488.8(a)(2)(iv), DNV GL
developed an action plan designed to: Strengthen DNV GL surveyor
documentation skills; consistently develop more detailed, quantifiable
deficiency statements that contain all evidence collected by the survey
team; and support the determination of the manner and degree of non-
compliance and the appropriate level of citation.
To meet the requirements at Sec. 489.13(b), DNV GL
revised its policy for determining the effective date of accreditation
for an initial and re-accreditation survey.
B. Term of Approval
Based on our review and observations described in section IV of
this final notice, we have determined that DNV GL's CAH accreditation
program requirements meet or exceed our requirements. Therefore, we
approve DNV GL as a national accreditation organization for CAHs that
request participation in the Medicare program, effective December 23,
2014 through December 23, 2020.
V. Collection of Information Requirements
This document does not impose information collection, recordkeeping
requirements or third party disclosure 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).
[[Page 69486]]
Dated: November 13, 2014.
Marilyn Tavenner,
Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2014-27576 Filed 11-20-14; 8:45 am]
BILLING CODE 4120-01-P