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[Federal Register Volume 79, Number 225 (Friday, November 21, 2014)]
[Notices]
[Pages 69482-69486]
From the Federal Register Online via the Government Printing 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
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