[Federal Register Volume 79, Number 48 (Wednesday, March 12, 2014)]
[Notices]
[Pages 14049-14051]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-05328]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-3286-FN]


Medicare and Medicaid Programs; Application From the Joint 
Commission for Continued Approval of Its Home Health Agency (HHA) 
Accreditation Program

AGENCY: Centers for Medicare and Medicaid Services, HHS.

ACTION: Final Notice.

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SUMMARY: This notice announces our decision to approve the Joint 
Commission for continued recognition as a national accreditation 
program for Home Health Agencies (HHAs) seeking to participate in the 
Medicare or Medicaid programs. An HHA that participates in Medicaid 
must, in accordance with Sec.  440.70(d) meet the Medicare 
participation requirements, and may demonstrate compliance through 
deemed status, as provided for under Sec.  488.6(b), with the exception 
of the capitalization requirements at Sec.  489.28.

DATES: Effective Date: This final notice is effective March 31, 2014 
through March 31, 2020.

FOR FURTHER INFORMATION CONTACT: Lillian Williams, (410) 786-8636, 
Patricia Chmielewski, (410) 786-6899, or Monda Shaver, (410) 786-3410.

SUPPLEMENTARY INFORMATION: 

I. Background

    Under the Medicare program, eligible beneficiaries may receive 
covered services from a HHA provided certain requirements are met. 
Sections 1861(o) and 1891 of the Social Security Act (the Act), 
establish distinct criteria for facilities seeking to participate in 
Medicare as an HHA. Regulations concerning Medicare provider agreements 
are at part 489 and those pertaining to activities relating to the 
survey and certification of facilities are at part 488. The regulations 
at part 484 specify the minimum conditions that a HHA must meet to be 
certified to participate in the Medicare program.
    Generally, to enter into a Medicare agreement, a HHA must first be 
certified by a state survey agency as complying with the conditions set 
forth in part 484 of the Medicare regulations. Thereafter, the HHA is 
subject to regular surveys by a State survey agency to determine 
whether it continues to meet these requirements. There is an 
alternative, however, to surveys by State agencies.
    Section 1865(a) of the Act provides that, if an accrediting 
organization is recognized by the Secretary as having standards for 
accreditation that meet or exceed all applicable Medicare conditions or 
requirements, as well as comparable survey procedures, a provider 
entity accredited under the national accrediting body's approved 
Medicare accreditation program would be deemed to meet the Medicare 
conditions or requirements. Accreditation under an approved Medicare 
accreditation program of an accrediting organization is voluntary and 
is not required for Medicare participation.
    A national accrediting organization applying for approval of its 
accreditation program in accordance with section 1865(a)(2) and (3) of 
the Act and our implementing regulations at part 488, subpart A, must 
provide us with reasonable assurance that the accrediting organization 
requires the accredited provider entities to meet requirements that are 
at least as stringent as all of the applicable Medicare conditions or 
requirements. Our regulations concerning the approval of accrediting 
organizations are set forth at Sec.  488.4 and Sec.  488.8(d)(3). The 
regulations at Sec.  488.8(d)(3) require accrediting organizations to 
reapply for continued approval of a Medicare accreditation program 
every 6 years or sooner, as determined by us.
    The Joint Commission's current term of approval for its HHA 
accreditation program expires March 31, 2014.

II. Approval of Deeming Organizations

    Section 1865(a)(2) of the Act and our regulations at Sec.  488.8(a) 
require that our findings concerning review and approval of a national 
accrediting organization's requirements consider, among other factors, 
the applying accrediting organization's requirements for accreditation; 
its survey procedures; its ability to provide adequate resources for 
conducting required surveys and to furnish us information for use in 
enforcement activities; its monitoring procedures for provider entities 
found not in compliance with the conditions or requirements; and its 
ability to provide us with the necessary data for validation.

[[Page 14050]]

    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. Proposed Notice

    On October 25, 2013, we published a proposed notice (78 FR 63984) 
announcing the Joint Commission's request for re-approval of its 
Medicare accreditation program for HHAs. In the proposed notice, we 
detailed our evaluation criteria. Under section 1865(a)(2) of the Act 
and our regulations at Sec.  488.4 (Application and reapplication 
procedures for accreditation organizations), we conducted a review of 
the Joint Commission's application in accordance with the criteria 
specified by our regulation, which include, but are not limited to the 
following:
     An onsite administrative review of the Joint Commission'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 the Joint Commission's HHA accreditation 
standards to our current Medicare HHA conditions of participation.
     A documentation review of the Joint Commission's survey 
processes to:
    ++ Determine the composition of the survey team, surveyor 
qualifications, and the ability of the Joint Commission to provide 
continuing surveyor training.
    ++ Compare the Joint Commission's processes to those we require of 
State survey agencies, including survey frequency, and the ability to 
investigate and respond appropriately to complaints against accredited 
facilities.
    ++ Evaluate the Joint Commission's procedures for monitoring 
providers or suppliers found to be out of compliance with the Joint 
Commission HHA program requirements. The monitoring procedures are 
required only when the Joint Commission identifies noncompliance. If 
substantial noncompliance is identified through a state validation 
survey, the state survey agency monitors corrections as specified at 
Sec.  488.7(d).
    ++ Assess the Joint Commission's ability to report deficiencies to 
the surveyed facility and respond to the facility's plan of correction 
in a timely manner.
    ++ Establish the Joint Commission's ability to provide us with 
electronic data and reports in requested format necessary for effective 
validation and assessment of the Joint Commission's survey process.
    ++ Review the Joint Commission's ability to provide adequate 
funding for performing required surveys.
    ++ Confirm the Joint Commission's policies with respect to whether 
surveys are announced or unannounced.
    ++ Obtain the Joint Commission's agreement to provide us with a 
copy of the most recent 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 
25, 2013 proposed notice (78 FR 63984) also solicited public comments 
regarding whether the Joint Commission's requirements meet or exceed 
the Medicare conditions of participation for HHAs. We received no 
public comments in response to our proposed notice.

IV. Provisions of the Final Notice

A. Differences Between the Joint Commission's Standards and 
Requirements for Accreditation and Medicare's Conditions and Survey 
Requirements

    We compared the standards contained in the Joint Commission's 
Medicare program accreditation requirements for HHAs and its survey 
process in the Joint Commission's Application for Renewal of Deeming 
Authority for HHA Facilities with the Medicare HHA conditions for 
participation and our State Operations Manual. Our review and 
evaluation of the Joint Commission's accreditation application, which 
were conducted as described in section III. of this final notice, 
yielded the following:
     To meet the requirements at Sec.  484.2, the Joint 
Commission revised its glossary to include all HHA definitions.
     To meet the requirements at Sec.  484.4(a)(1), the Joint 
Commission revised it's glossary to include the required qualifications 
for an Occupational Therapist and Occupational Therapy assistant.
     To meet the requirements at Sec.  484.4, the Joint 
Commission revised it's glossary to include the required qualifications 
for a Physical Therapist and Physical Therapy Assistant.
     To meet the requirements at Sec.  484.10, the Joint 
Commission revised its standards to address the requirement that the 
HHA protect and promote the exercise of a patient's rights.
     To meet the requirements at Sec.  484.10(b)(5), the Joint 
Commission revised its standards to address the requirement that the 
HHA ``must'' investigate complaints.
     To meet the requirements at Sec.  484.10(d), the Joint 
Commission modified its standards to ensure the patient's right to 
confidentiality of the medical record.
     To meet the requirements at Sec.  484.10(f), the Joint 
Commission revised its standards to address the patient's right to use 
the HHA hotline to lodge complaints concerning the implementation of 
the advance directives requirements.
     To meet the requirements at Sec.  484.36(c)(1), the Joint 
Commission revised its policies and procedures to ensure patient care 
instructions provided to the home health aide are clearly written and 
do not include the use of visit ranges and other assignments at the 
discretion of the aide.
     To meet the requirements at Sec.  484.14(b), the Joint 
Commission revised its standards to address the governing body's 
responsibility to adopt and periodically review written bylaws or an 
acceptable equivalent and oversee fiscal affairs.
     To meet the requirements at Sec.  484.16, the Joint 
Commission modified its standards to require that the group of 
professional personnel establish and annually review policies governing 
medical supervision, plans of care, and personnel qualifications.
     To meet the requirements at Sec.  484.18, the Joint 
Commission revised its standards to require the plan of care be 
established by a doctor of medicine, osteopathy, or podiatric medicine.
     To meet the requirements at Sec.  484.18(c), the Joint 
Commission revised its standards to require ``an assessment for 
contraindications'' be conducted prior to administration of drugs and 
treatment.
     To meet the requirements at Sec.  484.32(a), the Joint 
Commission revised its standards to address the requirement that a 
physical therapy assistant or occupational therapy assistant can 
perform services planned, delegated, and supervised by the therapist.
     To meet the requirements at Sec.  484.36, the Joint 
Commission modified its standards to ensure the home health aide's 
competence in providing care.
     To meet the requirements at Sec.  484.36(a)(2)(i)(B), the 
Joint Commission revised its standards to

[[Page 14051]]

include a reference to the personnel qualifications at Sec.  484.4.
     To meet the requirements at Sec.  484.38, the Joint 
Commission revised its standards to address the additional health and 
safety requirements set forth in Sec.  485.711, Sec.  485.713, Sec.  
485.715, Sec.  485.719, Sec.  485.723, and Sec.  485.727 of the Code of 
Federal Regulations (CFR) to implement section 1861(p) of the Act.
     To meet the requirements at Sec.  484.48(b), the Joint 
Commission revised its standards to ensure clinical record information 
is ``safeguarded against loss.''
     To meet the requirements at Sec.  484.52, the Joint 
Commission revised its standards to ensure the HHA's required annual 
self-evaluation assess the extent to which the agency's program is 
appropriate, adequate, effective and efficient.
     To meet the requirements at Sec.  484.52(b), the Joint 
Commission revised its standards to ensure the HHA include appropriate 
health professionals that represent ``the scope of the program'' in the 
required quarterly internal HHA review of a sample of clinical records.
     To meet the requirements at Sec.  488.4(b)(3)(iii) and 
Sec.  488.8(d)(1), the Joint Commission revised its policies to ensure 
that CMS is notified in advance of any proposed changes in its approved 
Medicare HHA accreditation program.
     To meet the requirements of the Joint Commission's 
Appendix L ``Addendum for Home Health Deemed Status Surveys'', the 
Joint Commission modified its policy to ensure surveyors conduct the 
required number of case reviews that include observing home visits.
     The Joint Commission amended its policy to clearly state 
that follow-up surveys following identification of condition-level non-
compliance are conducted within 45 ``calendar'' days of the survey end 
date.
     During the review of the Joint Commission's application, 
CMS issued notice to the Joint Commission with respect to all of its 
CMS-approved Medicare accreditation programs, in connection with its 
citation practices and its use of standards that are frequency-based 
and require a minimum frequency of observations of deficient practices 
before a citation will be made, so-called ``C- weighted'' standards. 
Due to the fact that this letter was released late in the review of the 
Joint Commission's current HHA application, there was not sufficient 
time for the Joint Commission to fully implement and provide evidence 
of sustained compliance with the provisions of this notice. To verify 
compliance in this area, CMS will conduct a follow-up survey 
observation and corporate onsite within one year of the date of 
publication of this notice.

B. Term of Approval

    Based on the review and observations described in section III. of 
this final notice, we have determined that the Joint Commission's 
requirements for HHAs meet or exceed our requirements. Therefore, we 
approve the Joint Commission as a national accreditation organization 
for HHAs that request participation in the Medicare program, effective 
March 31, 2014 through March 31, 2020.

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).

    Dated: March 6, 2014.
Marilyn Tavenner,
Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2014-05328 Filed 3-11-14; 8:45 am]
BILLING CODE 4120-01-P