[Federal Register Volume 84, Number 62 (Monday, April 1, 2019)]
[Notices]
[Pages 12260-12262]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-06149]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-3369-FN]
Medicare and Medicaid Programs: Application From the American
Association for Accreditation of Ambulatory Surgery Facilities, Inc.
(AAAASF) for Its Outpatient Physical Therapy and Speech Language
Pathology Services Accreditation Program
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Final notice.
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SUMMARY: This final notice announces our decision to approve the
American Association for Accreditation of Ambulatory Surgery
Facilities, Inc. (AAAASF) for continued recognition as a national
accrediting organization for clinics, rehabilitation agencies, or
public health agencies that furnish outpatient physical therapy and
speech language pathology services that wish to participate in the
Medicare or Medicaid programs.
DATES: The approval announced in this notice is effective on April 4,
2019 through April 4, 2025.
FOR FURTHER INFORMATION CONTACT: Erin Imhoff, (410) 786-2337; Monda
Shaver, (410) 786-3410; or Tara Lemons, (410) 786-3030.
[[Page 12261]]
SUPPLEMENTARY INFORMATION:
I. Background
Under Section 1861(p) of the Social Security Act (the Act),
eligible beneficiaries may receive outpatient physical therapy and
speech language pathology (OPT) services from a provider of services, a
clinic, rehabilitation agency, a public health agency, or others,
provided certain requirements are met. Section 1832(a)(2)(C) of the Act
permits payment for OPT services. 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 H, specify the
conditions that a clinic, rehabilitation agency or public health agency
(``OPT providers'') must meet in order to participate in the Medicare
program, the scope of covered services, and the conditions for Medicare
payment for OPT providers.
Generally, to enter into an agreement, an OPT provider must first
be certified by a State survey agency as complying with the conditions
of participation set forth in part 485, subpart H of our Medicare
regulations. Thereafter, the OPT provider is subject to regular surveys
by a state survey agency to determine whether it continues to meet
these requirements.
Section 1865(a)(1) of the Act provides that, if a provider entity
demonstrates through accreditation by a Centers for Medicare & Medicaid
Services (CMS) approved national accrediting organization (AO) that all
applicable Medicare conditions are met or exceeded, we may deem those
provider entities as having met the requirements. Accreditation by an
AO is voluntary and is not required for Medicare participation.
If an AO is recognized by the Secretary of the Department of Health
and Human Services (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)(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 210 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 October 30, 2018, we published a proposed notice in the Federal
Register (83 FR 54591) announcing the American Association for
Accreditation of Ambulatory Surgery Facilities, Inc. (AAAASF's) request
for continued approval of its Medicare OPT 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. 488.5, we
conducted a review of AAAASF's Medicare OPT accreditation renewal
application in accordance with the criteria specified by our
regulations, which include, but are not limited to the following:
An onsite administrative review of AAAASF's: (1) Corporate
policies; (2) financial and human resources available to accomplish the
proposed surveys; (3) procedures for training, monitoring, and
evaluation of its OPT surveyors; (4) ability to investigate and respond
appropriately to complaints against accredited OPTs; and, (5) survey
review and decision-making process for accreditation.
The comparison of AAAASF's Medicare OPT accreditation
program standards to our current Medicare OPT CoPs.
A documentation review of AAAASF's survey process to:
++ Determine the composition of the survey team, surveyor
qualifications, and AAAASF's ability to provide continuing surveyor
training.
++ Compare AAAASF's processes to those we require of state survey
agencies, including periodic resurvey and the ability to investigate
and respond appropriately to complaints against accredited OPTs.
++ Evaluate AAAASF's procedures for monitoring OPTs it has found to
be out of compliance with AAAASF's program requirements. (This pertains
only to monitoring procedures when AAAASF identifies non-compliance. If
noncompliance is identified by a state survey agency through a
validation survey, the state survey agency monitors corrections as
specified at Sec. 488.9(c).)
++ Assess AAAASF's ability to report deficiencies to the surveyed
OPT and respond to the OPTs plan of correction in a timely manner.
++ Establish AAAASF'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 AAAASF's staff and other resources.
++ Confirm AAAASF's ability to provide adequate funding for
performing required surveys.
++ Confirm AAAASF's policies with respect to surveys being
unannounced.
++ Obtain AAAASF'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 October
30, 2018 proposed notice also solicited public comments regarding
whether AAAASF's requirements met or exceeded the Medicare CoPs for
OPTs. We received no comments in response to our proposed notice.
IV. Provisions of the Final Notice
A. Differences Between AAAASF's Standards and Requirements for
Accreditation and Medicare Conditions and Survey Requirements
We compared AAAASF's OPT accreditation program requirements and
survey process with the Medicare CoPs at part 485 subpart H, and the
survey and certification process requirements of parts 488 and 489. Our
review and evaluation of AAAASF's OPT application, which were conducted
as described in section III of this final notice, yielded the following
areas where, as of the date of this notice, AAAASF has revised its
standards and certification processes in order to meet the requirements
at:
Section 485.701, to ensure AAAASF's standards
appropriately reference the CMS standards;
Section 485.703, definition of ``supervision'' at (2)(ii),
to ensure AAAASF's standards appropriately reference the CMS standards;
Section 485.705(a), to ensure AAAASF's standards
appropriately reference the CMS standards;
[[Page 12262]]
Section 485.705(c)(2) through (c)(6), to ensure AAAASF's
standards appropriately reference the CMS standards;
Section 485.719(b)(3), to ensure AAAASF's standards
appropriately reference the statutory requirements;
Section 488.5(a)(4)(ii), to ensure that an appropriate
number of medical records are fully reviewed during the survey process
and that survey record totals are accurately reflected in the overall
deficiency statement;
Section 488.5(a)(4)(iv), to ensure all deficiencies found
on survey are cited in AAAASF's final survey report;
Section 488.5(a)(4)(vii), to ensure appropriate monitoring
of non-compliance correction;
Section 488.5(a)(11)(ii), to ensure accurate survey
findings are reported to CMS;
Section 488.5(a)(13)(ii), to ensure AAAASF notifies CMS
regarding any decision to revoke, withdraw, or revise the accreditation
status of a deemed status supplier;
Section 488.26(b) and (c), to ensure deficiencies are
cited at the appropriate level based on manner and degree of findings;
Section 488.28(a), to ensure AAAASF's policies for an
acceptable plan of correction meet the CMS requirements;
Section 488.28(d), to ensure that AAAASF's policies for
correction of deficiencies in OPTs is comparable to CMS requirements,
requiring that deficiencies normally must be corrected within 60 days;
and
Section 489.13(b)(1), to ensure all enrollment
requirements are met prior to AAAASF surveying an initial applicant.
B. Term of Approval
Based on our review and observations described in section III of
this final notice, we approve AAAASF as a national accreditation
organization for OPTs that request participation in the Medicare
program, effective April 4, 2019 through April 4, 2025.
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. Chapter 35).
Dated: March 15, 2019.
Seema Verma,
Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2019-06149 Filed 3-29-19; 8:45 am]
BILLING CODE 4120-01-P