[Federal Register Volume 86, Number 38 (Monday, March 1, 2021)]
[Notices]
[Pages 12005-12006]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-04169]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-3400-FN]


Medicare and Medicaid Programs; Application From the 
Accreditation Commission for Health Care (ACHC) for Continued Approval 
of its Home Health Agency Accreditation Program

AGENCY: Centers for Medicare & Medicaid Services (CMS), Department of 
Health and Human Services (HHS).

ACTION: Final notice.

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

SUMMARY: This final notice announces our decision to approve The 
Accreditation Commission for Health Care (ACHC) for continued 
recognition as a national accrediting organization for home health 
agencies (HHAs) that wish to participate in the Medicare or Medicaid 
programs. An HHA that participates in Medicaid must also meet the 
Medicare conditions of participation (CoPs).

DATES: This decision announced in this final notice is effective 
February 24, 2021 through February 24, 2025.

FOR FURTHER INFORMATION CONTACT: Tara Lemons (410) 786-3030. Lillian 
Williams (410) 786-8636.

SUPPLEMENTARY INFORMATION:

I. Background

    Under the Medicare program, eligible beneficiaries may receive 
covered services from a home health agency (HHA), provided certain 
requirements are met. Sections 1861(m) and (o), 1891 and 1895 of the 
Social Security Act (the Act) establish distinct criteria for an entity 
seeking designation as an HHA. Regulations concerning provider 
agreements are at 42 CFR part 489 and those pertaining to activities 
relating to the survey and certification of facilities and other 
entities are at 42 CFR part 488. The regulations at 42 CFR parts 409 
and 484 specify the conditions that an HHA must meet to participate in 
the Medicare program, the scope of covered services and the conditions 
for Medicare payment for home health care.
    Generally, to enter into a provider agreement with the Medicare 
program, an HHA must first be certified by a state survey agency as 
complying with the conditions or requirements set forth in 42 CFR part 
484 of our regulations. Thereafter, the HHA 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 
certification surveys by state agencies. Accreditation by a nationally 
recognized Medicare accreditation program approved by CMS may 
substitute for both initial and 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 that all applicable Medicare conditions are met or 
exceeded, we will deem those provider entities as having met our 
requirements. Accreditation by an accrediting organization is voluntary 
and is not required for Medicare participation.
    If an accrediting organization is recognized by the Secretary 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 
would be deemed to meet the Medicare conditions. A national accrediting 
organization applying for CMS approval of their accreditation program 
under 42 CFR part 488, subpart A, must provide CMS with reasonable 
assurance that the accrediting organization requires the accredited 
provider entities to meet requirements that are at least as stringent 
as the Medicare conditions. Our regulations concerning the approval of 
accrediting organizations are set forth at Sec.  488.5. Section 
488.5(e)(2)(i) requires accrediting organizations to reapply for 
continued approval of its Medicare accreditation program every 6 years 
or sooner as determined by CMS.
    The Accreditation Commission for Health Care (ACHC's) term of 
approval for their HHA accreditation program expires February 24, 2021.

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

    In the September 28, 2020 Federal Register (85 FR 60796), we 
published a proposed notice announcing ACHC's request for continued 
approval of its Medicare HHA accreditation program. In the September 
28, 2020 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 ACHC's Medicare HHA accreditation application in 
accordance with the criteria specified by our regulations, which 
include, but are not limited to the following:
     An administrative review of ACHC's: (1) Corporate 
policies; (2) financial and human resources available to accomplish the 
proposed surveys; (3) procedures for training, monitoring, and 
evaluation of its HHA surveyors; (4) ability to investigate and respond 
appropriately to complaints against accredited HHAs; and (5) survey 
review and decision-making process for accreditation.
     The comparison of ACHC's Medicare HHA accreditation 
program standards to our current Medicare conditions of participation 
(CoPs) for HHAs.
     A documentation review of ACHC's survey process to do the 
following:
    ++ Determine the composition of the survey team, surveyor 
qualifications, and ACHC's ability to provide continuing surveyor 
training.
    ++ Compare ACHC'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 HHAs.
    ++ Evaluate ACHC's procedures for monitoring HHAs it has found to 
be out of compliance with ACHC's program requirements. (This pertains 
only to monitoring procedures when ACHC 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 ACHC's ability to report deficiencies to the surveyed 
HHAs and respond to the HHAs plan of correction in a timely manner.
    ++ Establish ACHC's ability to provide CMS with electronic data and 
reports necessary for effective validation and assessment of the 
organization's survey process.

[[Page 12006]]

    ++ Determine the adequacy of ACHC's staff and other resources.
    ++ Confirm ACHC's ability to provide adequate funding for 
performing required surveys.
    ++ Confirm ACHC's policies with respect to surveys being 
unannounced.
    ++ Confirm ACHC's policies and procedures to avoid conflicts of 
interest, including the appearance of conflicts of interest, involving 
individuals who conduct surveys or participate in accreditation 
decisions.
    ++ Obtain ACHC'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 September 
28, 2020 proposed notice also solicited public comments regarding 
whether ACHC's requirements met or exceeded the Medicare CoPs for HHAs. 
No comments were received in response to our proposed notice.

IV. Provisions of the Final Notice

A. Differences Between ACHC's Standards and Requirements for 
Accreditation and Medicare Conditions and Survey Requirements

    We compared ACHC's HHA accreditation requirements and survey 
process with the Medicare CoPs of parts 409 and 484, and the survey and 
certification process requirements of parts 488 and 489. Our review and 
evaluation of ACHC's HHA 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, ACHC has completed revising its 
standards and certification processes in order to meet the following 
requirements:
     Section 484.102(b) to include the requirement to review 
and update emergency preparedness policies and procedures at least 
every 2 years.
     Section 484.105(b)(1)(i) to ensure that the administrator 
is appointed by and reports to the governing body.
     Section 488.26(b) to ensure surveyor documentation 
relating to non-compliance with particular Medicare conditions reflects 
the manner and degree of non-compliance, cited at the appropriate level 
(that is, condition versus standard level).
     Section 488.5(a)(4)(vii) to describe ACHC's procedures and 
timelines for monitoring provider's or supplier's correction of 
identified non-compliance with relevant standards, including the 
criteria ACHC uses to determine when a desk review versus an on-site 
review would be acceptable for monitoring the correction of non-
compliance.

B. Term of Approval

    Based on our review and observations described in section III. of 
this final notice, we approve ACHC as a national accreditation 
organization for HHAs that request participation in the Medicare 
program, effective February 24, 2021 through February 24, 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. 3501 et seq.).
    The Acting Administrator of the Centers for Medicare & Medicaid 
Services (CMS), Elizabeth Richter, having reviewed and approved this 
document, authorizes Lynette Wilson, who is the Federal Register 
Liaison, to electronically sign this document for purposes of 
publication in the Federal Register.

    Dated: February 24, 2021.
Lynette Wilson,
Federal Register Liaison, Centers for Medicare & Medicaid Services.
[FR Doc. 2021-04169 Filed 2-26-21; 8:45 am]
BILLING CODE 4120-01-P