[Federal Register: June 23, 2006 (Volume 71, Number 121)]
[Notices]
[Page 36100-36101]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr23jn06-54]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-2228-FN]
Medicare and Medicaid Programs; Denial of the T[Uuml]V Healthcare
Specialists Request for Deeming Authority for Hospitals
AGENCY: Centers for Medicare & Medicaid Services, HHS.
ACTION: Final notice.
-----------------------------------------------------------------------
SUMMARY: This final notice announces our decision to deny T[Uuml]V
Healthcare Specialists' (T[Uuml]VHS) request for deeming authority for
hospitals that wish to participate in the Medicare and Medicaid
programs.
EFFECTIVE DATE: This final notice is effective June 23, 2006.
FOR FURTHER INFORMATION CONTACT: Amber MacCarroll, (410) 786-6773.
SUPPLEMENTARY INFORMATION:
I. Background
Under the Medicare program, eligible beneficiaries may receive
covered services in a hospital provided certain requirements are met.
The regulations specifying the Medicare conditions of participation
(CoP) for hospitals are located at 42 CFR part 482. These conditions
implement section 1861(e) of the Social Security Act (the Act), which
specifies the conditions that a hospital program must meet in order to
participate in the Medicare program. 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, in order to enter into an agreement with CMS, a hospital
must first be certified by a State survey agency as complying with the
conditions or requirements set forth in part 482 of our regulations.
Then, the hospital 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(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 will ``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.
The Joint Commission on Accreditation of Healthcare Organizations
(JCAHO) and the American Osteopathic Association (AOA) are currently
the only approved national accreditation organizations for hospitals.
II. Deeming Applications Review Process
Section 1865(b)(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 accreditation organization's requirements for
accreditation, including health and safety standards; survey
procedures; resources for conducting required surveys; capacity to
furnish information for use in enforcement activities; monitoring
procedures for provider entities found not in compliance with the
conditions or requirements; and ability to provide us with the
necessary data for validation.
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. At the end of the 210-day period, we must
publish an approval or denial of the application.
III. Proposed Notice
On January 27, 2006, we published a proposed notice (71 FR 4584)
announcing T[Uuml]V Healthcare Specialists' (T[Uuml]VHS') request for
approval as a deeming organization for hospitals. In the proposed
notice, we detailed our evaluation criteria as set forth in section
1865(b)(2) of the Act and our regulations at Sec. 488.8 (Federal
review of accreditation organizations). Our review and evaluation of
T[Uuml]VHS was conducted in accordance with, but not necessarily
limited to, the following factors:
The equivalency of T[Uuml]VHS' standards for hospitals as
compared with our Medicare hospital conditions of participation; and
T[Uuml]VHS' survey process to determine the following:
--The composition of the survey team, surveyor qualifications, and the
ability of the organization to provide continuing survey or training.
--The comparability of T[Uuml]VHS' survey procedures to those of State
agencies, including survey frequency, and the ability to investigate
and respond appropriately to complaints against accredited facilities.
--T[Uuml]VHS' processes and procedures for monitoring providers or
suppliers found out of compliance with T[Uuml]VHS program requirements.
These monitoring procedures are used only when T[Uuml]VHS identifies
noncompliance. If noncompliance is identified through validation
reviews, the survey agency monitors corrections as specified at Sec.
488.7(d).
--T[Uuml]VHS' capacity to report deficiencies to the surveyed
facilities and respond to the facility's plan of correction in a timely
manner.
--T[Uuml]VHS' capacity to provide us with electronic data in ASCII
comparable code, and reports necessary for
[[Page 36101]]
effective validation and assessment of the organization's survey
process.
--The adequacy of T[Uuml]VHS' staff and other resources, and its
financial viability.
--T[Uuml]VHS' capacity to adequately fund required surveys.
--T[Uuml]VHS' policies with respect to whether surveys are announced or
unannounced.
--T[Uuml]VHS' 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).
IV. Analysis of and Response to Public Comments on the Proposed Notice
We received 12 comments in response to the proposed notice
published on January 27, 2006. These comments were from hospitals,
professional organizations, an accrediting body and other individuals.
Summaries of the public comments we received and our responses to those
comments are set forth below.
Comment: The majority of commenters expressed support for increased
competition in the hospital accreditation arena.
Response: We appreciate the commenters' support and agree that the
accreditation process can benefit from increased competition. CMS must,
however, ensure that any national accreditation organization approved
for deeming authority meets our requirements and can provide us with
reasonable assurance that its accredited hospitals are in compliance
with accreditation standards that meet or exceed the Medicare CoPs.
Comment: A few commenters expressed support specifically for the
approval of T[Uuml]VHS' request for deeming authority. Conversely, one
commenter expressed concerns about the T[Uuml]VHS accreditation process
and provided specific technical comments regarding the ISO 9001
certification process.
Response: Based on our findings from the review of T[Uuml]VHS'
application, T[Uuml]VHS has not demonstrated that it meets our
requirements for approval as a national accreditation organization.
Also, T[Uuml]VHS did not provide us with reasonable assurance that its
accredited hospitals are in compliance with accreditation standards
that meet or exceed the Medicare CoPs.
Comment: One commenter asked us to consider the apparent conflict
of interest that is posed by T[Uuml]VHS offering consultative services
to prepare hospitals for JCAHO's accreditation reviews, while
requesting deeming authority for Medicare participating hospitals,
which would be in direct competition to JCAHO.
Response: We agree that it is an unusual situation to have an
organization apply for deeming authority while continuing to offer
consultative services to prepare hospitals for accreditation surveys
that are conducted by another accreditation organization. Because we
are not granting deeming authority to T[Uuml]VHS at this time, the
suggested conflict of interest is not relevant.
V. Provisions of the Final Notice
Based on the findings from our review, using the evaluation
criteria described above, we determined that the T[Uuml]VHS
accreditation requirements for hospitals, including the accreditation
standards, standards application and interpretation, survey procedures,
and corrective action requirements, are not equivalent to the CMS
requirements for hospitals. Additionally, T[Uuml]VHS has not provided
reasonable assurance that the hospitals they accredit are in compliance
with accreditation standards that are at least as stringent as the
Medicare Hospital CoPs.
The findings from the review, as described above, preclude us from
granting T[Uuml]VHS deeming authority for hospitals.
VI. Executive Order 12866 Statement
In accordance with the provisions of Executive Order 12866, this
regulation was not reviewed by the Office of Management and Budget.
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--Supplementary Medical Insurance
Program)
Dated: June 9, 2006.
Mark B. McClellan,
Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. E6-9907 Filed 6-22-06; 8:45 am]
BILLING CODE 4120-01-P