Medicare and Medicaid Programs; Announcement of an Application From a Hospital Requesting Waiver for Organ Procurement Service Area, 50372-50373 [05-16796]
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50372
Federal Register / Vol. 70, No. 165 / Friday, August 26, 2005 / Notices
Authority: Section 1923(a)(2), (f), and (h) of
the Social Security Act (42 U.S.C. 1396r–
4(a)(2), (f), and (h), and Pub. L. 105–33).
(Catalog of Federal Domestic Assistance
Program No. 93.778, Medical Assistance
Program)
Dated: May 6, 2005.
Mark B. McClellan,
Administrator, Centers for Medicare &
Medicaid Services.
Approved: May 20, 2005.
Michael O. Leavitt,
Secretary.
[FR Doc. 05–16997 Filed 8–25–05; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[CMS–1309–NC]
Medicare and Medicaid Programs;
Announcement of an Application From
a Hospital Requesting Waiver for
Organ Procurement Service Area
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Notice with comment period.
AGENCY:
SUMMARY: This notice announces a
hospital’s request for a waiver from
entering into an agreement with its
designated organ procurement
organization (OPO), in accordance with
section 1138(a)(2) of the Social Security
Act. This notice requests comments
from OPOs and the general public for
our consideration in determining
whether we should grant the requested
waiver.
DATES: To be assured consideration,
comments must be received at one of
the addresses provided below, no later
than 5 p.m. on October 25, 2005.
ADDRESSES: In commenting, please refer
to file code CMS–1309–NC. Because of
staff and resource limitations, we cannot
accept comments by facsimile (FAX)
transmission.
You may submit comments in one of
four ways (no duplicates, please):
1. Electronically. You may submit
electronic comments on specific issues
in this regulation to https://
www.cms.hhs.gov/regulations/
ecomments. (Attachments should be in
Microsoft Word, WordPerfect, or Excel;
however, we prefer Microsoft Word.)
2. By regular mail. You may mail
written comments (one original and two
copies) to the following address ONLY:
Centers for Medicare & Medicaid
Services, Department of Health and
Human Services, Attention: CMS–1309–
VerDate jul<14>2003
16:18 Aug 25, 2005
Jkt 205001
NC, P.O. Box 8015, Baltimore, MD
21244–8015.
Please allow sufficient time for mailed
comments to be received before the
close of the comment period.
3. By express or overnight mail. You
may send written comments (one
original and two copies) to the following
address ONLY: Centers for Medicare &
Medicaid Services, Department of
Health and Human Services, Attention:
CMS–1309–NC, Mail Stop C4–26–05,
7500 Security Boulevard, Baltimore, MD
21244–1850.
4. By hand or courier. If you prefer,
you may deliver (by hand or courier)
your written comments (one original
and two copies) before the close of the
comment period to one of the following
addresses. If you intend to deliver your
comments to the Baltimore address,
please call telephone number (410) 786–
9994 in advance to schedule your
arrival with one of our staff members.
Room 445–G, Hubert H. Humphrey
Building, 200 Independence Avenue,
SW., Washington, DC 20201; or 7500
Security Boulevard, Baltimore, MD
21244–1850.
(Because access to the interior of the
HHH Building is not readily available to
persons without Federal Government
identification, commenters are
encouraged to leave their comments in
the CMS drop slots located in the main
lobby of the building. A stamp-in clock
is available for persons wishing to retain
a proof of filing by stamping in and
retaining an extra copy of the comments
being filed.)
Comments mailed to the addresses
indicated as appropriate for hand or
courier delivery may be delayed and
received after the comment period.
For information on viewing public
comments, see the beginning of the
SUPPLEMENTARY INFORMATION section.
FOR FURTHER INFORMATION CONTACT:
Mark A. Horney, (410) 786–4554.
SUPPLEMENTARY INFORMATION:
Submitting Comments: We welcome
comments from the public on all issues
set forth in this notice with comment
period to assist us in fully considering
issues and developing policies. You can
assist us by referencing the file code
CMS–1309–NC and the specific ‘‘issue
identifier’’ that precedes the section on
which you choose to comment.
Inspection of Public Comments: All
comments received before the close of
the comment period are available for
viewing by the public, including any
personally identifiable or confidential
business information that is included in
a comment. CMS posts all electronic
comments received before the close of
the comment period on its public Web
PO 00000
Frm 00082
Fmt 4703
Sfmt 4703
site as soon as possible after they have
been received. Hard copy comments
received timely will be available for
public inspection as they are received,
generally beginning approximately 3
weeks after publication of a document,
at the headquarters of the Centers for
Medicare & Medicaid Services, 7500
Security Boulevard, Baltimore,
Maryland 21244, Monday through
Friday of each week from 8:30 a.m. to
4 p.m. To schedule an appointment to
view public comments, phone 1–800–
743–3951.
I. Background
[If you choose to comment on issues in
this section, please include the caption
‘‘BACKGROUND’’ at the beginning of
your comments.]
Organ Procurement Organizations
(OPOs) are not-for-profit organizations
that recover human organs from
potential donors in hospitals and
distribute them to transplant centers
throughout the country. Qualified OPOs
are designated by the Centers for
Medicare & Medicaid Services (CMS) to
recover organs in CMS-defined
exclusive geographic service areas,
according to section 371(b)(1)(F) of the
Public Health Service Act (42 U.S.C.
273(b)(1)(F)) and our regulations at 42
CFR 486.307. Once an OPO has been
designated for an area, hospitals in that
area that participate in Medicare and
Medicaid are required to work with that
OPO in providing organs for transplant,
according to section 1138(a) of the
Social Security Act (the Act), and our
regulations at 42 CFR 482.45. Section
1138(a)(1)(A)(iii) of the Act provides
that a hospital must notify the
designated OPO (for the service area in
which it is located) of potential organ
donors. Under section 1138(a)(1)(C) of
the Act, every participating hospital
must have an agreement to identify
potential donors only with its
designated OPO.
However, section 1138(a)(2) of the Act
provides that a hospital may obtain a
waiver of the above requirements from
the Secretary under certain specified
conditions. A waiver allows the hospital
to have an agreement with an OPO other
than the one initially designated by
CMS, if the hospital meets certain
conditions specified in section
1138(a)(2) of the Act. In addition, the
Secretary may review additional criteria
described in section 1138(a)(2)(B) of the
Act to evaluate the hospital’s request for
a waiver.
Section 1138(a)(2)(A) of the Act states
that in granting a waiver, the Secretary
must determine that the waiver: (1) Is
expected to increase organ donations;
and (2) will ensure equitable treatment
E:\FR\FM\26AUN1.SGM
26AUN1
Federal Register / Vol. 70, No. 165 / Friday, August 26, 2005 / Notices
of patients referred for transplants
within the service area served by the
designated OPO and within the service
area served by the OPO with which the
hospital seeks to enter into an
agreement under the waiver. In making
a waiver determination, section
1138(a)(2)(B) of the Act provides that
the Secretary may consider, among
other factors: (1) Cost-effectiveness; (2)
improvements in quality; (3) whether
there has been any change in a
hospital’s designated OPO due to the
changes made in definitions for
metropolitan statistical areas (MSAs);
and (4) the length and continuity of a
hospital’s relationship with an OPO
other than the hospital’s designated
OPO. Under section 1138(a)(2)(D) of the
Act, the Secretary is required to publish
a notice of any waiver application
within 30 days of receiving the
application, and to offer interested
parties an opportunity to comment in
writing during the 60-day period
beginning on the publication date in the
Federal Register.
The criteria that the Secretary uses to
evaluate the waiver in these cases are
the same as those described above under
sections 1138(a)(2)(A) and (B) of the Act
and have been incorporated into the
regulations at 42 CFR 486.316(e) and (f).
II. Waiver Request Procedures
In October 1995, we issued a Program
Memorandum (Transmittal No. A–95–
11) detailing the waiver process and
discussing the information that
hospitals must provide in requesting a
waiver. We indicated that upon receipt
of a waiver request, we would publish
a Federal Register notice to solicit
public comments, as required by section
1138(a)(2)(D) of the Act.
According to these requirements, we
will review the request and comments
received. During the review process, we
may consult on an as-needed basis with
the Public Health Service’s Division of
Transplantation, the United Network for
Organ Sharing, and our regional offices.
If necessary, we may request additional
clarifying information from the applying
hospital or others. We will then make a
final determination on the waiver
request and notify the hospital and the
designated and requested OPOs.
III. Hospital Waiver Request
As permitted by 42 CFR 486.316(e),
Rockford Health System of Rockford,
Illinois has requested a waiver in order
to enter into an agreement with an
alternative, out-of-area OPO. Rockford
Health System is requesting a waiver to
work with: University of Wisconsin
OPO, University of Wisconsin Hospital
and Clinic, 600 Highland Avenue,
VerDate jul<14>2003
16:18 Aug 25, 2005
Jkt 205001
Madison, Wisconsin 53792. Rockford
Health System’s designated OPO is: Gift
of Hope Organ and Tissue Donor
Network, 660 North Industrial Drive,
Elmhurst, Il 60126–1520. Rockford
Health System must continue to work
with its designated OPO until the
completion of our review.
Authority: Section 1138 of the Social
Security Act (42 U.S.C. 1320b–8).
(Catalog of Federal Domestic Assistance
Program No. 93.773, Medicare—Hospital
Insurance; Program No. 93.774, MedicareSupplementary Medical Insurance, and
Program No. 93.778, Medical Assistance
Program)
Dated: August 9, 2005.
Mark B. McClellan,
Administrator, Centers for Medicare &
Medicaid Services.
[FR Doc. 05–16796 Filed 8–25–05; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[CMS–4106–PN]
Medicare Program; Changes in
Medicare Advantage Deeming
Authority
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Proposed notice.
AGENCY:
SUMMARY: This proposed notice
announces that on September 26, 2005,
we will begin to accept revisions from
private accrediting organizations (AOs)
who seek to modify their deeming
authority.
This proposed notice is
effective on September 26, 2005.
FOR FURTHER INFORMATION CONTACT:
Shaheen Halim, 410–786–0641.
SUPPLEMENTARY INFORMATION:
EFFECTIVE DATE:
I. Background
Section 4001 of the Balanced Budget
Act of 1997 (BBA) (Pub. L. 105–33),
enacted on August 5, 1987, added
section 1852(e)(4) to the Social Security
Act (the Act), which gives us the
authority to determine that a Medicare
Advantage (MA) organization is deemed
to be in compliance with certain
Medicare requirements if the MA
organization has been accredited (and is
periodically reaccredited) by an
accrediting organization that we have
determined applies and enforces
requirements at least as stringent as
those the MA organization would be
deemed to meet. Section 518 of the
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Frm 00083
Fmt 4703
Sfmt 4703
50373
Balanced Budget Refinement Act of
1999 (BBRA) (Pub. L. 106–113), enacted
on November 29, 1999, amended section
1852(e)(4) of the Act to expand the
scope of deeming from two to six areas.
Accrediting organizations may seek
authority for any of the categories. The
BBRA specified that we cannot require
an accrediting entity to be able to certify
plans for all the deeming categories. It
also required us to determine, within
210 days from the day the application
is determined to be complete, the
eligibility of the accrediting
organizations to be granted deeming
authority. Conditions and procedures
for granting deeming authority to
accrediting organizations are outlined in
§ 422.157 and § 422.158 of title 42 of the
Code of Federal Regulations.
Since the start of the Medicare
Deeming program, we have approved
three organizations to be AOs. These
consist of the National Committee for
Quality Assurance, the Joint
Commission on the Accreditation of
Healthcare Organizations, and
Accreditation Association for
Ambulatory Health Care (AAAHC).
Section 722 of the Medicare
Prescription Drug, Improvement, and
Modernization Act of 2003 (MMA) (Pub.
L. 108–173) revised section 1852(e)(4) of
the Act. When we published the final
rule of the Medicare Advantage program
on January 28, 2005 (70 FR 4588), we
made further changes to several sections
of the rules that apply to the AOs. These
changes consisted of the addition of the
Chronic Care Improvement Program
requirements (§ 422.152), and the
deletion of some requirements in the
areas of access and quality improvement
projects. (§ 422.112 and § 422.152).
Furthermore, it added prescription drug
program requirements to the deemable
areas. These areas include:
• Access to covered drugs, as
provided under § 423.120 and § 423.124.
• Drug utilization management
programs, quality assurance measures
and systems, and Medication Therapy
Management Programs as provided
under § 423.153.
• Privacy, confidentiality, and
accuracy of enrollee records, as
provided under § 423.136.
• A program to protect against fraud,
waste and abuse, as described in
§ 423.504(b)(4)(vi)(H).
II. Provisions of the Proposed Notice
This proposed notice announces that
30 days after publication, we will begin
to accept applications from national
private AOs who seek to modify their
deeming authority. The application will
consist of a letter stating how the
applicant will modify their
E:\FR\FM\26AUN1.SGM
26AUN1
]]>Agencies
[Federal Register Volume 70, Number 165 (Friday, August 26, 2005)]
[Notices]
[Pages 50372-50373]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-16796]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-1309-NC]
Medicare and Medicaid Programs; Announcement of an Application
From a Hospital Requesting Waiver for Organ Procurement Service Area
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Notice with comment period.
-----------------------------------------------------------------------
SUMMARY: This notice announces a hospital's request for a waiver from
entering into an agreement with its designated organ procurement
organization (OPO), in accordance with section 1138(a)(2) of the Social
Security Act. This notice requests comments from OPOs and the general
public for our consideration in determining whether we should grant the
requested waiver.
DATES: To be assured consideration, comments must be received at one of
the addresses provided below, no later than 5 p.m. on October 25, 2005.
ADDRESSES: In commenting, please refer to file code CMS-1309-NC.
Because of staff and resource limitations, we cannot accept comments by
facsimile (FAX) transmission.
You may submit comments in one of four ways (no duplicates,
please):
1. Electronically. You may submit electronic comments on specific
issues in this regulation to https://www.cms.hhs.gov/regulations/
ecomments. (Attachments should be in Microsoft Word, WordPerfect, or
Excel; however, we prefer Microsoft Word.)
2. By regular mail. You may mail written comments (one original and
two copies) to the following address ONLY: Centers for Medicare &
Medicaid Services, Department of Health and Human Services, Attention:
CMS-1309-NC, P.O. Box 8015, Baltimore, MD 21244-8015.
Please allow sufficient time for mailed comments to be received
before the close of the comment period.
3. By express or overnight mail. You may send written comments (one
original and two copies) to the following address ONLY: Centers for
Medicare & Medicaid Services, Department of Health and Human Services,
Attention: CMS-1309-NC, Mail Stop C4-26-05, 7500 Security Boulevard,
Baltimore, MD 21244-1850.
4. By hand or courier. If you prefer, you may deliver (by hand or
courier) your written comments (one original and two copies) before the
close of the comment period to one of the following addresses. If you
intend to deliver your comments to the Baltimore address, please call
telephone number (410) 786-9994 in advance to schedule your arrival
with one of our staff members. Room 445-G, Hubert H. Humphrey Building,
200 Independence Avenue, SW., Washington, DC 20201; or 7500 Security
Boulevard, Baltimore, MD 21244-1850.
(Because access to the interior of the HHH Building is not readily
available to persons without Federal Government identification,
commenters are encouraged to leave their comments in the CMS drop slots
located in the main lobby of the building. A stamp-in clock is
available for persons wishing to retain a proof of filing by stamping
in and retaining an extra copy of the comments being filed.)
Comments mailed to the addresses indicated as appropriate for hand
or courier delivery may be delayed and received after the comment
period.
For information on viewing public comments, see the beginning of
the SUPPLEMENTARY INFORMATION section.
FOR FURTHER INFORMATION CONTACT: Mark A. Horney, (410) 786-4554.
SUPPLEMENTARY INFORMATION: Submitting Comments: We welcome comments
from the public on all issues set forth in this notice with comment
period to assist us in fully considering issues and developing
policies. You can assist us by referencing the file code CMS-1309-NC
and the specific ``issue identifier'' that precedes the section on
which you choose to comment.
Inspection of Public Comments: All comments received before the
close of the comment period are available for viewing by the public,
including any personally identifiable or confidential business
information that is included in a comment. CMS posts all electronic
comments received before the close of the comment period on its public
Web site as soon as possible after they have been received. Hard copy
comments received timely will be available for public inspection as
they are received, generally beginning approximately 3 weeks after
publication of a document, at the headquarters of the Centers for
Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore,
Maryland 21244, Monday through Friday of each week from 8:30 a.m. to 4
p.m. To schedule an appointment to view public comments, phone 1-800-
743-3951.
I. Background
[If you choose to comment on issues in this section, please include the
caption ``BACKGROUND'' at the beginning of your comments.]
Organ Procurement Organizations (OPOs) are not-for-profit
organizations that recover human organs from potential donors in
hospitals and distribute them to transplant centers throughout the
country. Qualified OPOs are designated by the Centers for Medicare &
Medicaid Services (CMS) to recover organs in CMS-defined exclusive
geographic service areas, according to section 371(b)(1)(F) of the
Public Health Service Act (42 U.S.C. 273(b)(1)(F)) and our regulations
at 42 CFR 486.307. Once an OPO has been designated for an area,
hospitals in that area that participate in Medicare and Medicaid are
required to work with that OPO in providing organs for transplant,
according to section 1138(a) of the Social Security Act (the Act), and
our regulations at 42 CFR 482.45. Section 1138(a)(1)(A)(iii) of the Act
provides that a hospital must notify the designated OPO (for the
service area in which it is located) of potential organ donors. Under
section 1138(a)(1)(C) of the Act, every participating hospital must
have an agreement to identify potential donors only with its designated
OPO.
However, section 1138(a)(2) of the Act provides that a hospital may
obtain a waiver of the above requirements from the Secretary under
certain specified conditions. A waiver allows the hospital to have an
agreement with an OPO other than the one initially designated by CMS,
if the hospital meets certain conditions specified in section
1138(a)(2) of the Act. In addition, the Secretary may review additional
criteria described in section 1138(a)(2)(B) of the Act to evaluate the
hospital's request for a waiver.
Section 1138(a)(2)(A) of the Act states that in granting a waiver,
the Secretary must determine that the waiver: (1) Is expected to
increase organ donations; and (2) will ensure equitable treatment
[[Page 50373]]
of patients referred for transplants within the service area served by
the designated OPO and within the service area served by the OPO with
which the hospital seeks to enter into an agreement under the waiver.
In making a waiver determination, section 1138(a)(2)(B) of the Act
provides that the Secretary may consider, among other factors: (1)
Cost-effectiveness; (2) improvements in quality; (3) whether there has
been any change in a hospital's designated OPO due to the changes made
in definitions for metropolitan statistical areas (MSAs); and (4) the
length and continuity of a hospital's relationship with an OPO other
than the hospital's designated OPO. Under section 1138(a)(2)(D) of the
Act, the Secretary is required to publish a notice of any waiver
application within 30 days of receiving the application, and to offer
interested parties an opportunity to comment in writing during the 60-
day period beginning on the publication date in the Federal Register.
The criteria that the Secretary uses to evaluate the waiver in
these cases are the same as those described above under sections
1138(a)(2)(A) and (B) of the Act and have been incorporated into the
regulations at 42 CFR 486.316(e) and (f).
II. Waiver Request Procedures
In October 1995, we issued a Program Memorandum (Transmittal No. A-
95-11) detailing the waiver process and discussing the information that
hospitals must provide in requesting a waiver. We indicated that upon
receipt of a waiver request, we would publish a Federal Register notice
to solicit public comments, as required by section 1138(a)(2)(D) of the
Act.
According to these requirements, we will review the request and
comments received. During the review process, we may consult on an as-
needed basis with the Public Health Service's Division of
Transplantation, the United Network for Organ Sharing, and our regional
offices. If necessary, we may request additional clarifying information
from the applying hospital or others. We will then make a final
determination on the waiver request and notify the hospital and the
designated and requested OPOs.
III. Hospital Waiver Request
As permitted by 42 CFR 486.316(e), Rockford Health System of
Rockford, Illinois has requested a waiver in order to enter into an
agreement with an alternative, out-of-area OPO. Rockford Health System
is requesting a waiver to work with: University of Wisconsin OPO,
University of Wisconsin Hospital and Clinic, 600 Highland Avenue,
Madison, Wisconsin 53792. Rockford Health System's designated OPO is:
Gift of Hope Organ and Tissue Donor Network, 660 North Industrial
Drive, Elmhurst, Il 60126-1520. Rockford Health System must continue to
work with its designated OPO until the completion of our review.
Authority: Section 1138 of the Social Security Act (42 U.S.C.
1320b-8).
(Catalog of Federal Domestic Assistance Program No. 93.773,
Medicare--Hospital Insurance; Program No. 93.774, Medicare-
Supplementary Medical Insurance, and Program No. 93.778, Medical
Assistance Program)
Dated: August 9, 2005.
Mark B. McClellan,
Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 05-16796 Filed 8-25-05; 8:45 am]
BILLING CODE 4120-01-P
