[Federal Register: February 24, 2006 (Volume 71, Number 37)]
[Notices]
[Page 9564-9565]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr24fe06-90]
[[Page 9564]]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
[[Page 9565]]
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