[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]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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

[[Page 69685]]

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