[Federal Register Volume 75, Number 219 (Monday, November 15, 2010)]
[Notices]
[Pages 69682-69685]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-28666]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-2336-FN]
Medicare and Medicaid Programs; Approval of Det Norske Veritas
Healthcare for Deeming Authority for Critical Access Hospitals
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Final notice.
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SUMMARY: This final notice announces our decision to approve Det Norske
Veritas Healthcare (DNVHC) for recognition as a national accreditation
program for critical access hospitals seeking to participate in the
Medicare or Medicaid programs.
DATES: Effective Date: This final notice of approval is effective
December 23, 2010, through December 23, 2014.
FOR FURTHER INFORMATION CONTACT:
Lillian Williams, (410) 786-8636.
Patricia Chmielewski, (410) 786-6899.
SUPPLEMENTARY INFORMATION:
I. Background
Under the Medicare program, eligible beneficiaries may receive
covered services in a critical access hospitals (CAHs) provided certain
requirements are met. Sections 1820(c)(2)(B) and 1861(mm) of the Social
Security Act (the Act) establish distinct criteria for facilities
seeking designation as a CAH. The minimum requirements that a CAH must
meet to participate in Medicare are set forth in regulation at 42 CFR
part 485, subpart F. Conditions for Medicare payment for CAHs are set
forth at Sec. 413.70. Applicable regulations concerning provider
agreements are located in 42 CFR part 489, and those pertaining to
facility survey and
[[Page 69683]]
certification are in 42 CFR part 488, subparts A and B.
For a CAH to enter into a provider agreement with the Medicare
program, a CAH must first be certified by a State survey agency as
complying with the conditions or requirements set forth in section 1820
of the Act, and 42 CFR part 485 of the regulations. Subsequently, the
CAH is subject to ongoing review by a State survey agency to determine
whether it continues to meet the Medicare requirements. However, there
is 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 provides that, if a provider entity
demonstrates through accreditation by an approved national
accreditation organization (AO) that all applicable Medicare conditions
are met or exceeded, we may ``deem'' that provider entity as having met
the requirements. Accreditation by an AO is voluntary and is not
required for Medicare participation. A national AO applying for deeming
authority under 42 CFR 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.
II. Deeming Application Approval Process
Section 1865(a)(3)(A) of the Act provides a statutory timetable to
ensure that our review of applications for deeming authority is
conducted in a timely manner. The statute provides us 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 process. Within 60 days after 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 a
notice in the Federal Register approving or denying the application.
III. Provisions of the Proposed Notice and Response to Comments
In the July 26, 2010 Federal Register (75 FR 43531), we published a
proposed notice announcing DNVHC's request for approval as a deeming
organization for CAHs. 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, 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.
A comparison of DNVHC's CAH accreditation standards to our
current Medicare CAH conditions of participation (CoPs).
A documentation review of DNVHC's survey processes to:
+ 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 providers or suppliers
found to be 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 DNVHC's
survey process.
+ Determine the adequacy of staff and other resources.
+ Review 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 July 26,
2010 proposed notice also solicited public comments regarding whether
DNVHC's requirements met or exceeded the Medicare CoPs for CAHs. We
received five comments in response to our proposed notice.
All of the commenters expressed support for DNVHC's application for
CAH deeming authority. The commenters stated that DNVHC's standards are
clearly written and closely align with the Medicare CoPs, and that
DNVHC's accreditation program provides CAHs with a viable alternative
to other healthcare AOs.
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 CAH accreditation requirements and survey
process with the Medicare 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:
To meet the requirements at Sec. 485.641(b)(4), DNVHC
revised its crosswalk to ensure deficiencies regarding credentialing
and quality assurance are correctly cited and cross-walked to the
Medicare requirements.
To ensure consistent and accurate documentation, DNVHC
revised its onsite survey protocol to require surveyors use and forward
all surveyor worksheets to the corporate office for inclusion in the
survey file.
To meet the survey process requirements at appendix W of
the SOM, DNVHC revised its policies to require the medical record
sample size be no less than 20 inpatient records.
To meet the requirements at appendix W of the SOM, DNVHC
revised its policies to require the conduct of patient interviews
during the survey.
To meet the requirements at section 5075.9 of the SOM,
DNVHC revised its policies to require an onsite survey within 45
calendar days for complaints triaged as operational requiring a special
survey.
To meet the requirements at Sec. 485.608(d), DNVHC
revised its standards to address the certification or registration
requirements of CAH personnel.
To meet the requirements at Sec. 485.618(c)(2) and Sec.
485.618(d)(1), DNVHC revised its standards to replace the term
physician with ``doctor of medicine or osteopathy.''
To meet the requirements at Sec. 485.618(d)(3)(iii)
through Sec. 485.618(d)(4), DNVHC revised its onsite surveyor protocol
to require surveyors to verify, if applicable, that the CAH has
received permission from
[[Page 69684]]
CMS to use registered nurses with training and experience as qualified
professionals in emergency care, on a temporary basis, be included in
the list of personnel immediately available to provide emergency care.
To meet the requirements at Sec. 485.620, DNVHC revised
its standards to address the number of beds and length of stay
requirements for CAHs.
To meet the requirements at Sec. 485.623(b), DNVHC
revised its standards to include housekeeping and preventive
maintenance programs.
To meet the requirements at Sec. 485.623(c)(3), DNVHC
revised its standards to ensure the CAH provides an emergency fuel
supply.
To meet the requirements at Sec. 485.623(d)(7)(iv), DNVHC
revised its standards to include the reference to the National Fire
Protection Association (NFPA) Tentative Interim Amendments (TIA) 00-01
(101).
To meet the requirements at Sec. 485.623(d)(7)(i) through
Sec. 485.623(d)(7)(iv), DNVHC revised its standards to ensure alcohol-
based dispensers are installed in accordance with chapter 18.3.2.7 or
chapter 19.3.2.7 of the 2000 edition of the Life Safety Code.
To meet the requirements at Sec. 485.635(a)(3)(i), DNVHC
revised its standards to ensure the CAH's policies include a
description of the services provided, either directly or through an
agreement or arrangement.
To meet the requirements at Sec. 485.635(a)(3)(iii),
DNVHC revised its standards to ensure the CAH's policies include
guidelines for healthcare conditions that may require a patient
referral.
To meet the requirements at Sec. 485.635(a)(4), DNVHC
revised its standards to require that a group of professional personnel
review the CAH policies on an annual basis.
To meet the requirements at Sec. 485.635(b)(1), DNVHC
revised its standards to ensure direct services of the CAH include the
medical history, physical examination, specimen collection, assessment
of health status, and treatment for a variety of medical conditions.
To meet the requirements at Sec. 485.635(b)(3), DNVHC
revised its standards to ensure staff and patients of the CAH are not
exposed to radiation hazards.
To meet the requirements at Sec. 485.635(d)(3), DNVHC
revised its standards to ensure drugs and biologicals are administered
by and under the supervision of a registered nurse, a doctor of
medicine or osteopathy, or, where permitted, a physician assistant, in
accordance with written and signed orders.
To meet the requirements at Sec. 485.635(e), DNVHC
revised its standards to ensure therapy services provided at the CAH
are consistent with the requirements at Sec. 409.17 of our rules.
To meet the requirements at Sec. 485.638(a)(4)(i), DNVHC
revised its standards to ensure the patient's medical record include a
brief summary of the episode.
To meet the requirements at Sec. 485.638(c), DNVHC
revised its standards to ensure clinical records are retained longer
than six years from the date of the record's last entry, if such is
required by State statute, or if the records are needed for a pending
proceeding.
To meet the requirements at Sec. 485.639(b)(3), DNVHC
revised its standards to ensure patients receiving surgical services at
the CAH are evaluated for proper anesthesia recovery by a qualified
practitioner.
To meet the requirements at Sec. 485.641(b)(1), DNVHC
revised its standards to ensure all CAH services that affect patient
health and safety are evaluated.
To meet the requirements at Sec. 485.645(a)(2), DNVHC
revised its standards to ensure the CAH provides no more than 25
inpatient beds.
To meet the requirements at Sec. 485.645(d)(8), DNVHC
revised its standards to address the requirement that if the CAH
provides or obtains dental services from an outside resource, that
service must be in accordance with the requirements at Sec. 483.55 and
Sec. 483.75(h).
To meet the Skilled Nursing Facilities (SNF) requirements
applicable to swing beds at Sec. 483.12(a)(1), DNVHC revised its
standards to ensure transfer and discharge of a patient includes
transfer to a bed outside of the certified facility.
To meet the SNF swing bed requirements at Sec.
483.20(b)(2), DNVHC revised its standards to ensure the comprehensive
assessment is completed within 14 calendar days after admission and not
less than every 12 months.
To meet the requirements at Sec. 483.20(k)(1)(ii), DNVHC
revised its standards to ensure that the comprehensive care plan
addresses situations where services that would be otherwise required
under Sec. 483.25 are not provided due the patient's right to refuse
treatment under Sec. 483.10(b)(4).
To meet the requirements at Sec. 483.20(l)(2), DNVHC
revised its standards to ensure the discharge summary includes a final
summary of the patient's status and is available for release to
authorized persons and agencies, with the consent of the patient or
legal representative.
To meet the requirements at Sec. 412.25(a)(2), DNVHC
revised its standards to ensure the CAH's written admission criteria is
applied uniformly to both Medicare and non-Medicare patients.
To meet the requirements at Sec. 412.25(d), DNVHC revised
its standards to ensure the CAH has only one psychiatric or
rehabilitation unit excluded from the prospective payment systems.
To meet the requirements at Sec. 412.27(d)(1), DNVHC
revised its standards to ensure the CAH provides an adequate number of
qualified doctors of medicine and osteopathy for essential psychiatric
services.
To meet the requirements at Sec. 482.11(b)(2), DNVHC
revised its standards to require hospitals located in States that do
not provide licensure meet the approved standards established by that
State.
To meet the requirements at Sec. 482.12(c)(2) through
Sec. 482.12(c)(4)(ii), DNVHC revised its standards to address who can
admit patients.
Regarding our capitalization and capital plan requirements
for health maintenance organizations (HMOs) and civil monetary
penalties (CMP) that operate hospitals, DNVHC revised its standards to
ensure, with respect to such entities, the institutional plan and
budget include the following requirements:
+ The facilities do not provide common services at the same site.
+ The facilities are not available under a contract of reasonable
duration.
+ Full and equal medical staff privileges in the facilities are not
available.
+ Arrangements with these facilities are not administratively
feasible.
+ The purchase of these services is more costly than if the health
maintenance organization (HMO) or competitive medical plan (CMP)
provided services directly.
To meet the requirements at Sec. 485.618, DNVHC revised
its standards to clarify that emergency services must be provided
directly.
To meet the requirements at Sec. 482.13(e)(13), DNVHC
revised its standards to address the requirement that States are free
to have restraint and seclusion requirements by statute or regulation
that are more restrictive than CMS standards.
To meet the requirements at Sec. 482.21, DNVHC revised
its standards to require that hospitals maintain and
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demonstrate evidence of its quality assessment and performance
improvement program (QAPI) program for review by CMS.
To meet the requirements at Sec. 482.21(a)(1), DNVHC
revised its standards to ensure QAPI is an ongoing program that shows
measurable improvements in indicators for which there is evidence that
it will improve health outcomes and identify and reduce medical errors.
To meet the requirements at Sec. 482.21(a)(2), DNVHC
revised its standards to ensure the hospital's QAPI program includes
aspects of performance that assess process of care, hospital service,
and operations.
To meet the requirements at Sec. 482.21(c)(2), DNVHC
revised its standards to address the hospital's responsibility to,
among other things, implement preventive actions and mechanisms that
include feedback and learning throughout the hospital as part of its
performance improvement activities.
To meet the requirements at Sec. 482.21(d)(2), DNVHC
revised its standards to clarify that a hospital may chose, as one of
its quality initiatives, to develop and implement an information
technology system to improve patient safety and quality.
To meet the requirements at Sec. 482.23(c), DNVHC revised
its standards to ensure all drugs and biologicals are administered
under the orders of a practitioner responsible for the care of the
patient as specified at Sec. 482.12(c).
To meet the requirements at Sec. 482.23(c)(3), DNVHC
revised its standards to include the requirement that blood
transfusions and intravenous medications must be administered in
accordance with State laws and approved medical staff policies and
procedures.
To meet the requirements at Sec. 482.23(c)(4), DNVHC
revised its standards to require blood transfusion reactions be
reported immediately to the attending physician.
To meet the requirements at Sec. 482.30(a)(2), DNVHC
revised its standards to address situations where CMS has determined
that the utilization review (UR) procedures established by a State
under title XIX of the Act are superior to those listed in 42 CFR part
482, thus requiring hospitals in that State to meet the utilization
control requirements at Sec. 456.50 through Sec. 456.245 of this
chapter of the regulations.
To meet the requirements at Sec. 482.30(c)(4) and Sec.
482.30(e)(2), DNVHC revised its standards to require that the CAH
review cases where the patient's length of stay exceeds the mean length
of stay for the applicable diagnostic-related group (DRG) and the
hospitals charges for covered services exceed the DRG payment rate.
To meet the requirements at Sec. 482.30(d)(1)(i) through
Sec. 482.30(d)(3), DNVHC revised its standards to ensure
determinations regarding admissions or continued stays are made by the
practitioner responsible for the patient as specified in Sec.
482.12(c).
To meet the requirements at Sec. 482.30(e)(ii), DNVHC
revised its standards to require that the utilization review committee
conduct a periodic review of each current inpatient receiving hospital
services during a continuous period of extended duration for hospitals
not paid under the prospective payment system.
To meet the requirements at Sec. 482.42(a)(2), DNVHC
revised its standards to require the infection control officer maintain
a log of incidents related to infections and communicable diseases.
To meet the requirements at Sec. 482.43(e), DNVHC revised
its standards to require that the CAH periodically reevaluate its
discharge planning process.
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
CAHs meet or exceed our requirements. Therefore, we approve DNVHC as a
national accreditation organization for CAHs that request participation
in the Medicare program, effective December 23, 2010, through December
23, 2014.
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).
VI. Regulatory Impact Statement
In accordance with the provisions of Executive Order 12866, this
regulation was not reviewed by the Office of Management and Budget.
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) (Catalog of Federal Domestic Assistance Program
No. 93.773, Medicare--Hospital Insurance; and Program No. 93.774,
Medicare--Supplementary Medical Insurance Program).
Dated: October 27, 2010.
Donald M. Berwick,
Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2010-28666 Filed 11-12-10; 8:45 am]
BILLING CODE 4120-01-P