[Federal Register Volume 71, Number 37 (Friday, February 24, 2006)]
[Notices]
[Pages 9564-9565]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 06-1650]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-2227-FN]


Medicare and Medicaid Programs; Approval of Deeming Authority of 
the Accreditation Commission for Healthcare (ACHC) for Home Health 
Agencies

AGENCY: Centers for Medicare and Medicaid Services, HHS.

ACTION: Final notice.

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SUMMARY: This notice announces our decision to approve the 
Accreditation Commission for Healthcare (ACHC) for recognition as a 
national accreditation program for home health agencies seeking to 
participate in the Medicare or Medicaid programs.

DATES: Effective Date: This final notice is effective February 24, 2006 
through February 24, 2009.

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

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(o) and 1891 of the Social Security 
Act (the Act) establish distinct criteria for facilities seeking 
designation as an HHA in the Medicare 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. Regulations concerning eligibility 
for home health and certain payment requirements are at 42 CFR part 
409, Subpart E.
    Generally, to enter into an agreement, a 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.

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 23, 2005, we published a proposed notice (70 FR 55862) 
announcing the Accreditation Commission for Healthcare's (ACHC's) 
request for approval 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), we 
conducted a review of the ACHC application in accordance with the 
criteria specified by our regulation, which include, but are not 
limited to the following:
     An onsite 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 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 ACHC's HHA accreditation standards to our 
current Medicare HHA conditions for participation.
     A documentation review of ACHC's survey processes to:
    [boxvh] Determine the composition of the survey team, surveyor 
qualifications, and the ability of ACHC to provide continuing surveyor 
training.
    [boxvh] Compare ACHC's processes to those of State survey agencies, 
including survey frequency, and the ability to investigate and respond 
appropriately to complaints against accredited facilities.
    [boxvh] Evaluate ACHC's procedures for monitoring providers or 
suppliers found to be out of compliance with ACHC program requirements. 
The monitoring procedures are used only when the ACHC identifies 
noncompliance. If noncompliance is identified through validation 
reviews, the survey agency monitors corrections as specified at Sec.  
488.7(d).
    [boxvh] Assess ACHC's ability to report deficiencies to the 
surveyed facilities and respond to the facility's plan of correction in 
a timely manner.
    [boxvh] Establish ACHC's ability to provide us with electronic data 
in ASCII-comparable code and reports necessary for effective validation 
and assessment of ACHC's survey process.
    [boxvh] Determine the adequacy of staff and other resources.
    [boxvh] Review ACHC's ability to provide adequate funding for 
performing required surveys.
    [boxvh] Confirm ACHC's policies with respect to whether surveys are 
announced or unannounced.
    [boxvh] Obtain ACHC'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 
23, 2005 proposed notice (70 FR 55862) also solicited public comments 
regarding whether ACHC's requirements met or exceeded 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 ACHC's Standards and Requirements for 
Accreditation and Medicare's Conditions and Survey Requirements

    We compared the standards contained in ACHC's accreditation manual 
for

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HHAs and its survey process in ACHC's Surveyor Training Manual with the 
Medicare HHA conditions for participation and our State Operations 
Manual. Our review and evaluation of ACHC's deeming application, which 
were conducted as described in section III of this final notice yielded 
the following:
     To meet the full intent of all Medicare standards and 
conditions, ACHC crosswalked the corresponding Medicare standard to 
each of its standards and stated that HHAs undergoing a deemed status 
survey from ACHC would meet the ACHC standard as well as the 
corresponding Medicare standard.
     ACHC added time frames to respond to complaints in all 
categories listed in its complaint process.
     ACHC revised its survey procedures to add triggers for 
identification of Immediate Jeopardy and the guidelines to determine 
when Immediate Jeopardy is removed.
     ACHC amended its guidelines for determining survey 
frequency for HHAs in accordance with the State Operations Manual (SOM) 
2195.
     In order to be consistent with our policy, ACHC modified 
the language in its policies to state that Branch Office Additions must 
first be approved by the CMS Regional Office before scheduling a 
survey.
     ACHC modified its policies to conform with our standards 
in SOM 2200 that HHAs applying for an initial certification survey 
provide care to at least 10 patients and that 7 of those 10 are still 
active at the time of the initial survey.
     To meet our standards listed in SOM 2200C4, ACHC amended 
its policies to include criteria necessary for the required number of 
home visits required during the survey.
     ACHC developed a systematic way to ensure that the 
appropriate number of active and closed records was reviewed for the 
size of the facility being surveyed in order to meet the standards 
listed at SOM 2200C5.
     ACHC established a new policy that requires all deemed 
HHAs to submit a Plan of Correction for all deficiencies identified.
     A new policy was developed by ACHC concerning the 
qualifications and training necessary for lead surveyors.
     ACHC will implement an annual training program for all its 
surveyors and incorporate a measurement tool that evaluates 
effectiveness of training.
     To meet the requirements listed in Sec.  488.4(b)(3)(v), 
ACHC established a policy that permits its surveyors to serve as 
witnesses if we take an adverse action based on accreditation findings.
     ACHC revised its policies to eliminate pre-survey contact 
and notification of surveyors to HHAs in order to meet our requirements 
of fully unannounced HHA surveys.

B. Term of Approval

    Based on the review and observations described in section III of 
this final notice, we have determined that ACHC's requirements for HHAs 
meet or exceed our requirements. Therefore, we recognize the ACHC as a 
national accreditation organization for HHAs that request participation 
in the Medicare program, effective February 24, 2006 through February 
24 2009.

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.

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) (Public 
Law 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 ACHC 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 ACHC 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)

    Dated: January 30, 2006.
Mark B. McClellan,
Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 06-1650 Filed 2-23-06; 8:45 am]
BILLING CODE 4120-01-P