[Federal Register Volume 84, Number 24 (Tuesday, February 5, 2019)]
[Notices]
[Pages 1737-1739]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-01103]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-3366-FN]
Medicare and Medicaid Programs: Approval of an Application From
National Dialysis Accreditation Commission for CMS Approval of Its End
Stage Renal Disease (ESRD) Facility Accreditation Program
AGENCY: Centers for Medicare and Medicaid Services (CMS), HHS.
ACTION: Final notice.
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SUMMARY: This final notice announces our decision to approve National
Dialysis Accreditation Commission (NDAC) for recognition as a national
accrediting organization (AO) for End Stage Renal Disease (ESRD)
Facilities that wish to participate in the Medicare or Medicaid
programs.
DATES: The approval announced in this notice is effective January 4,
2019 through January 4, 2023.
FOR FURTHER INFORMATION CONTACT: Renee Henry, (410) 786-7828, Monda
Shaver, (410) 786-3410 or Joann Fitzell (410) 786-4280.
SUPPLEMENTARY INFORMATION:
I. Background
Under the Medicare program, eligible beneficiaries may receive
covered services in an end stage renal disease (ESRD) facility,
provided the facility meets the requirements established by the
Secretary of the Department of Health and Human Services (the
Secretary). Section 1881(b) of the Social Security Act (the Act)
establishes distinct requirements for facilities seeking designation as
an ESRD facility under Medicare. Regulations concerning provider
agreements and supplier approval are at 42 CFR part 489 and those
pertaining to activities relating to the survey, certification, and
enforcement procedures of suppliers, which include ESRD facilities are
at 42 CFR part 488. The regulations at part 494 subparts A through D
implement section 1881(b) of the Act, which specify the conditions that
an ESRD facility must meet in order to participate in the Medicare
program and the conditions for Medicare payment for ESRD facilities.
For an ESRD facility to enter into a provider agreement with the
Medicare program, an ESRD facility must first be certified by a State
survey agency as complying with the conditions or requirements set
forth in section 1881(b) of the Act and our regulations at part 494
subparts A through D. Subsequently, the ESRD facility 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 the Secretary finds
that accreditation of a provider entity by an approved national
accrediting organization (AO) meets or exceeds all applicable Medicare
conditions, we may treat the provider entity as having met those
conditions, that is, we may ``deem'' the provider entity to be in
compliance. Accreditation by an AO is voluntary and is not required for
Medicare participation.
Section 1865(a)(1) of the Act had historically excluded dialysis
facilities from participating in Medicare via a Centers for Medicare &
Medicaid Services (CMS)-approved accreditation program; however,
section 50404 of the Bipartisan Budget Act of 2018 (Pub. L. 115-123)
amended section 1865(a) of the Act to include renal dialysis facilities
as provider entities allowed to participate in Medicare through a CMS-
approved accreditation program.
If an AO is recognized by the Secretary 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. An AO applying for
approval of its accreditation program under part 488, subpart A, must
provide CMS 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. 488.5.
II. Application Approval Process
Section 1865(a)(2) of the Act and our regulations at Sec. 488.5
require that our findings concerning review and approval of an AO's
requirements consider, among other factors, the applying AO's
requirements for accreditation; survey procedures; resources for
conducting required surveys; capacity to furnish information for use in
enforcement activities; monitoring procedures for provider entities
that were not in compliance with the conditions or requirements; and
their ability to provide CMS with the necessary data for validation.
Section 1865(a)(3)(A) of the Act further requires that we publish,
within 60 days of receipt of an organization's complete application, a
notice identifying the national accrediting body making the request,
describing the nature of the request, and providing at least a 30-day
public comment period. We have 210 days from the receipt of a complete
application to publish notice of approval or denial of the application.
III. Provisions of the Proposed Notice
On August 7, 2018, we published a proposed notice in the Federal
Register announcing National Dialysis Accreditation Commission's
(NDAC's) request for approval of its Medicare ESRD facility
accreditation program (83 FR 38697). 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 NDAC's
Medicare ESRD Facility accreditation application in accordance with the
criteria specified by our regulations, which include, but are not
limited to, the following:
An onsite administrative review of NDAC'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 ESRD facilities;
and, (5) survey review and decision-making process for accreditation.
A comparison of NDAC's Medicare accreditation program
standards to our current Medicare ESRD facility Conditions for Coverage
(CfCs).
A documentation review of NDAC's survey process to do the
following:
++ Determine the composition of the survey team, surveyor
qualifications, and NDAC's ability to provide continuing surveyor
training.
++ Compare NDAC's processes to those we require of State survey
agencies, including periodic re-survey and the ability to investigate
and respond appropriately to complaints against accredited ESRD
Facilities.
++ Evaluate NDAC's procedures for monitoring ESRD Facilities it has
found to be out of compliance with NDAC's program requirements. (This
pertains only to monitoring procedures when NDAC identifies non-
compliance. If non-compliance is identified by a State survey agency
through a validation survey, the State survey agency monitors
corrections as specified at Sec. 488.9(c)(1).
++ Assess NDAC's ability to report deficiencies to the surveyed
facilities
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and respond to the facility's plan of correction in a timely manner.
++ Establish NDAC's ability to provide CMS with electronic data and
reports necessary for effective validation and assessment of the
organization's survey process.
++ Determine the adequacy of NDAC's staff and other resources.
++ Confirm NDAC's ability to provide adequate funding for
performing required surveys.
++ Confirm NDAC's policies with respect to surveys being
unannounced.
++ Obtain NDAC's agreement to provide CMS 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 August 7,
2018, proposed notice also solicited public comments regarding whether
NDAC's requirements met or exceeded the Medicare CfCs for ESRD
facilities. Six comments were submitted. Of these comments, four were
in full support of approving NDAC as a new AO for ESRD Facilities. They
welcomed the additional support this would provide the industry in
certifying facilities. CMS thanks them for their support. One commenter
voiced support of allowing accreditation of ESRD facilities, but
expressed concern that continuing to allow State Survey Agencies to
conduct surveys when accreditation is allowed would cause confusion for
facilities. CMS thanks the commenter for their submission; however, the
law allows an ESRD facility to be surveyed by a State Survey Agency or
an accrediting organization. Accreditation by an AO is a voluntary
choice made by the ESRD facility. In addition, this process of allowing
certification either through accreditation by an AO or through a survey
performed by a State Survey Agency has been well established in other
programs and does not, to our knowledge, present any confusion to
providers. One commenter encouraged CMS to continue to recognize the
value of home-only programs. Another commenter expressed concern with
NDAC's ability to provide sufficient national coverage with limited
staffing available to travel and respond to certification needs and
complaints. This commenter also expressed concern over Conflict of
Interest related to NDAC conducting mock surveys in the past for some
facilities, which may be potential clients. In its application, NDAC
addressed staffing requirements adequately to support national
expansion. With respect to conflict of interest concerns, we believe
that NDAC addressed these concerns adequately in their application and
will conduct unbiased surveys. Firewalls and policies surrounding
conflicts of interest are in line with other approved AO programs.
IV. Provisions of the Final Notice
A. Differences Between NDAC's Standards and Requirements for
Accreditation and Medicare Conditions and Survey Requirements
We compared NDAC's ESRD facility accreditation requirements and
survey process with the Medicare CfCs at part 494, and the survey and
certification process requirements of parts 488 and 489. NDAC's
standards and standards crosswalk were also examined to ensure that the
appropriate CMS regulations would be included in citations as
appropriate. Our review and evaluation of NDAC's ESRD facility
application, which was conducted as described in section III of this
final notice, yielded the following areas where, as of the date of this
notice, NDAC has revised the following standards and certification
processes:
Section 494.30(a)(1)(i), to ensure that its interpretive
guidance accurately reflects the appropriate CMS standard.
Section 494.40(a), to ensure that appropriate maximum
allowable limits for microbial and endotoxin counts are comparable to
CMS requirements and to clarify that bacteria counts can be tested via
outside lab or dip test.
Section 494.60(d)(4)(ii), to correct its related standards
crosswalk to accurately reflect the CMS standards references and the
2012 edition of the Life Safety Code.
Section 494.70(a)(14), to clarify language that each
facility must develop and implement an internal grievance process.
Section 494.70(a)(16), to clarify language that each
facility must inform patients that they can file a grievance.
Section 494.70(d), to accurately reflect current CMS
regulations and references.
Section 494.90(b)(1)(i), to ensure that allowing an
Advanced Practice Registered Nurse or Physician Assistant to conduct
patient assessments and plans of care does not eliminate the physician
from participation in the interdisciplinary team and team discussions.
Section 494.170(b)(3), to ensure that ESRD facilities must
also meet this CMS requirement for home care patients who receive
supplies and equipment from a durable medical equipment supplier.
Section 494.180(b)(1), to ensure that State-specific
staffing requirements that are more stringent than CMS requirements
will be cited at as the appropriate CMS standard.
Section 494.180(c)(1), to ensure that State-specific
Medical-staff requirements that are more stringent than CMS
requirements will be cited at the appropriate CMS standard.
NDAC revised its policies and procedures to ensure that
its documentation demonstrates that the organization's survey reports
identify, for each finding of noncompliance with accreditation
standards, the appropriate comparable Medicare CfCs.
NDAC revised its policies and procedures to ensure that
all observations of non-compliance are noted on the final deficiency
report and to require that an acceptable plan of correction must be
submitted by the ESRD facility.
NDAC revised its policies, procedures and surveyor
worksheets to ensure that survey documentation is consistently and
accurately completed.
NDAC updated its policies and procedures to ensure that
the effective date of full accreditation does not precede the receipt
date of an acceptable plan of correction.
NDAC revised its policy to include language that would
specifically restrict the accreditation time period to no more than 36
months.
NDAC revised its policies and procedures to review and
assess surveyor documentation on survey reports to ensure that all
findings noted on the surveyor worksheets are clearly and accurately
reflected in the final survey (deficiency) report and that these
findings are quantifiable where appropriate.
NDAC revised its policies and procedures to ensure that a
survey report is generated for each survey, irrespective of
deficiencies found on a follow-up survey.
NDAC revised its policies and procedures to ensure that a
follow-up survey conducted for the purposes of ``clearing'' a previous
observation of non-compliance at the condition level, assesses
compliance with the entire condition that was previously cited.
NDAC revised its policies and procedures to include
``denial'' of accreditation when condition-level non-compliance is
found on an initial survey.
NDAC revised its policy related to conducting follow-up
surveys to clarify that the follow-up survey for condition-level non-
compliance must take place within 45 calendar days from the survey end
date for which the condition-level finding was originally made.
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B. Term of Approval
Based on our review and observations described in section III of
this final notice, we have determined that NDAC's ESRD facility
accreditation program requirements meet or exceed our requirements, and
its survey processes are also comparable. Therefore, we approve NDAC as
a national accreditation organization for ESRD facilities that request
participation in the Medicare program, effective January 4, 2019
through January 4, 2023.
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: January 2, 2019.
Seema Verma,
Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2019-01103 Filed 2-4-19; 8:45 am]
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