[Federal Register Volume 70, Number 57 (Friday, March 25, 2005)]
[Notices]
[Pages 15331-15333]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-5033]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-2204-FN]


Medicare and Medicaid Programs; Reapproval of the Deeming 
Authority of the Joint Commission on Accreditation of Healthcare 
Organizations (JCAHO) for Home Health Agencies

AGENCY: Centers for Medicare & Medicaid Services, HHS.

ACTION: Final notice.

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SUMMARY: This notice announces our decision to approve the Joint 
Commission on Accreditation of Healthcare Organizations for continued 
recognition as a national accreditation program for home health 
agencies seeking to participate in the Medicare or Medicaid programs.

EFFECTIVE DATE: This final notice is effective March 31, 2005 through 
March 31, 2008.

FOR FURTHER INFORMATION CONTACT: Cindy Melanson, (410) 786-0310.

SUPPLEMENTARY INFORMATION:

I. Background

    Under the Medicare program, eligible beneficiaries may receive 
covered services in a Home Health Agency (HHA) provided certain 
requirements are met. Sections 1861(o) and 1891 of the Social Security 
Act (the Act) establish distinct criteria for facilities seeking 
designation as an HHA program. The regulations at 42 CFR part 484 
specify the conditions that an HHA must meet in order to participate in 
the Medicare program, the scope of covered services, and the conditions 
for Medicare payment for home health care. 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.
    Generally, to enter into an agreement, an HHA must first be 
certified by a state survey agency as complying with the conditions or 
requirements set forth in part 484 of our regulations. Then, the HHA is 
subject to regular surveys by a state survey agency to determine 
whether it continues to meet those requirements. There is an 
alternative, however, to surveys by state agencies.
    Section 1865(b)(1) of the Act provides that, if a provider entity 
demonstrates through accreditation by an approved national 
accreditation organization that all applicable Medicare conditions are 
met or exceeded, we would ``deem'' those provider entities as having 
met the requirements. Accreditation by an accreditation organization is 
voluntary and is not required for Medicare participation.
    If an accreditation organization 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 would be deemed to meet the 
Medicare conditions. A national accreditation organization applying for 
approval of deeming authority under part 488, subpart A must provide us 
with reasonable assurance that the accreditation organization requires 
the accredited provider entities to meet requirements that are at least 
as stringent as the Medicare conditions. Our regulations concerning 
reapproval 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 
accreditation organizations to reapply for continued approval of 
deeming authority every 6 years or sooner as we determine. The Joint 
Commission on Accreditation of Healthcare Organizations' (JCAHO's) term 
of approval as a recognized accreditation program for HHAs expires 
March 31, 2005.

II. Deeming Applications Approval Process

    Section 1865(b)(3)(A) of the Act provides a statutory timetable to 
ensure that our review of deeming applications is conducted in a timely 
manner. The Act provides us with 210-calendar days after the date of 
receipt of an application to complete our survey activities and 
application review process. Within 60 days of receiving a completed 
application, we must publish a notice in the Federal Register that 
identifies the national accreditation 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 an 
approval or denial of the application.

III. Proposed Notice

    On September 24, 2004, we published a proposed notice (69 FR 57305) 
announcing the JCAHO's request for reapproval as a deeming organization 
for HHAs. In the proposed notice, we detailed our evaluation criteria. 
Under section 1865(b)(2) of the Act and our regulations at Sec.  488.4 
(Application and reapplication procedures for accreditation 
organizations) and Sec.  488.8 (Federal review of accreditation 
organization), we conducted a review of the JCAHO application in 
accordance with the criteria specified by our regulation, which 
include, but are not limited to the following:
     An onsite administrative review of JCAHO'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 JCAHO's HHA accreditation standards to our 
current Medicare HHA conditions for participation.

[[Page 15332]]

     A documentation review of JCAHO's survey processes to:
    + Determine the composition of the survey team, surveyor 
qualifications, and the ability of JCAHO to provide continuing surveyor 
training.
    + Compare JCAHO'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 JCAHO's procedures for monitoring providers or suppliers 
found to be out of compliance with JCAHO program requirements. The 
monitoring procedures are used only when the JCAHO identifies 
noncompliance. If noncompliance is identified through validation 
reviews, the survey agency monitors corrections as specified at Sec.  
488.7(d).
    + Assess JCAHO's ability to report deficiencies to the surveyed 
facilities and respond to the facility's plan of correction in a timely 
manner.
    + Establish JCAHO's ability to provide us with electronic data in 
ASCII-comparable code and reports necessary for effective validation 
and assessment of JCAHO's survey process.
    + Determine the adequacy of staff and other resources.
    + Review JCAHO's ability to provide adequate funding for performing 
required surveys.
    + Confirm JCAHO's policies with respect to whether surveys are 
announced or unannounced.
    + Obtain JCAHO'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(b)(3)(A) of the Act, the September 
24, 2004 proposed notice (69 FR 57305) also solicited public comments 
regarding whether JCAHO's requirements met or exceeded the Medicare 
conditions of participation for HHA. We received no public comments in 
response to our proposed notice.

IV. Provisions of the Final Notice

A. Differences Between the Joint Commission on Accreditation of 
Healthcare Organizations' and Medicare's Conditions and Survey 
Requirements

    We compared the standards contained in JCAHO's ``Comprehensive 
Accreditation Manual for Home Care'' and its survey process in the 
``Request for Continued Deeming Authority for Home Health Agencies 
Handbook'' with the Medicare HHA conditions for participation and our 
State Operations Manual. Our review and evaluation of JCAHO's deeming 
application, which were conducted as described in section III of this 
final notice yielded the following:
     To comply with the requirements at Sec.  484.20(a), JCAHO 
has agreed not to schedule the unannounced home health survey without 
written confirmation of a successful Outcomes and Assessment 
Information Set (OASIS) transmission.
     To meet the requirements at Sec.  488.4(b)(3)(v), JCAHO 
amended its policies and procedures to permit its surveyors to serve as 
witnesses if we take an adverse action based on accreditation findings.

B. Term of Approval

    Based on the review and observations described in sections III and 
IV of this final notice, we have determined that JCAHO's requirements 
for HHAs meet or exceed our requirements. Therefore, we recognize the 
JCAHO as a national accreditation organization for HHAs that request 
participation in the Medicare program. Because we are planning to 
revise the conditions of participation for HHAs over the next 3 years, 
we believe it is most appropriate to renew the current deeming 
authority for a similar period. As a result, we are approving JCAHO's 
program effective March 31, 2005 through March 31, 2008.

V. Collection of Information Requirements

    This final notice does not impose any information collection and 
record keeping requirements subject to the Paperwork Reduction Act 
(PRA). Consequently, it does not need to be reviewed by the Office of 
Management and Budget (OMB) under the authority of the PRA. The 
requirements associated with granting and withdrawal of deeming 
authority to national accreditation organizations, codified in 42 CFR 
part 488, ``Survey, Certification, and Enforcement Procedures,'' are 
currently approved by OMB under OMB approval number 0938-0690.

VI. Regulatory Impact Statement

    We have examined the impact of this final notice as required by 
Executive Order 12866 and the Regulatory Flexibility Act (RFA) (Pub. L. 
98-354). Executive Order 12866 directs agencies to assess all costs and 
benefits of available regulatory alternatives and, when regulation is 
necessary, to select regulatory approaches that maximize net benefits 
(including potential economic, environmental, public health and safety 
effects; distributive impacts; and equity). The RFA requires agencies 
to analyze options for regulatory relief for small businesses. For 
purposes of the RFA, States and individuals are not considered small 
entities.
    Also, section 1102(b) of the Act requires the Secretary to prepare 
a regulatory impact analysis for any notice that may have a significant 
impact on the operations of a substantial number of small rural 
hospitals. Such an analysis must conform to the provisions of section 
604 of the RFA. For purposes of section 1102(b) of the Act, we consider 
a small rural hospital as a hospital that is located outside of a 
Metropolitan Statistical Area and has fewer than 100 beds.
    This final notice recognizes JCAHO as a national accreditation 
organization for HHAs that request participation in the Medicare 
program. There are neither significant costs nor savings for the 
program and administrative budgets of Medicare. Therefore, this final 
notice is not a major rule as defined in Title 5, United States Code, 
section 804(2) and is not an economically significant rule under 
Executive Order 12866. We have determined, and the Secretary certifies, 
that this final notice will not result in a significant impact on a 
substantial number of small entities and will not have a significant 
effect on the operations of a substantial number of small rural 
hospitals. Therefore, we are not preparing analyses for either the RFA 
or section 1102(b) of the Act.
    In an effort to better assure the health, safety, and services of 
beneficiaries in HHAs already certified as well as provide relief to 
State budgets in this time of tight fiscal restraints, we deem HHAs 
accredited by JCAHO as meeting our Medicare requirements. Thus, we 
continue our focus on assuring the health and safety of services by 
providers and suppliers already certified for participation in a cost-
effective manner.
    In accordance with the provisions of Executive Order 12866, this 
notice was not reviewed by the Office of Management and Budget. In 
accordance with Executive Order 13132, we have determined that this 
final notice will not significantly affect the rights of States, local, 
or tribal governments.

    Authority: Section 1865 of the Social Security Act (42 U.S.C. 
1395bb)

(Catalog of Federal Domestic Assistance Program No. 93.778, Medical 
Assistance Program; No. 93.773 Medicare--Hospital Insurance Program; 
and No. 93.774, Medicare'Supplemental Medical Insurance Program)



[[Page 15333]]


    Dated: February 18, 2005.
Mark B. McClellan,
Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 05-5033 Filed 3-24-05; 8:45 am]
BILLING CODE 4120-01-P