[Federal Register: February 24, 2006 (Volume 71, Number 37)]
[Notices]
[Page 9562-9563]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr24fe06-89]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-1332-NC]
Medicare and Medicaid Programs; Announcement of an Application
From a Hospital Requesting a Waiver From Its Designated 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 April 25, 2006.
ADDRESSES: In commenting, please refer to file code CMS-1332-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 http://www.cms.hhs.gov/eRulemaking.
(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-1332-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-1332-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 to assist us in considering whether we
should grant the requested waiver. You can assist us by referencing the
file code CMS-1332-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
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 transplantation,
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 with its designated OPO to identify potential donors
only within its service area.
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 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
[[Page 9563]]
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 public comment period.
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, the
designated OPO, and the requested OPO.
III. Hospital Waiver Request
As permitted by 42 CFR 486.316(e), Piedmont Healthcare Systems of
Rock Hill, South Carolina has requested a waiver in order to enter into
an agreement with an alternative, out-of-area OPO. Piedmont Healthcare
Systems is requesting a waiver to work with: LifePoint, 4200 Faber
Place Drive, Charleston, SC 29105.
Piedmont Healthcare System's designated OPO is: LifeShare of the
Carolinas, 5000-D Airport Center Parkway, Charlotte, NC 28208.
Piedmont Healthcare Systems must continue to work with its
designated OPO while we complete our review.
IV. Collection of Information Requirements
This document does not impose information collection and
recordkeeping requirements. Consequently, it need not be reviewed by
the Office of Management and Budget under the authority of the
Paperwork Reduction Act of 1995 (44 U.S.C. 35).
Section 486.316 sets forth the requirements for a Medicare or
Medicaid participating hospital to request a waiver permitting the
hospital to have an agreement with an OPO other than the OPO designated
for the service area in which the hospital is located. The burden
associated with those requirements is currently approved under OMB
0938-0688, and HCFA-R-13, Conditions of Coverage for Organ Procurement
Organizations, with an expiration date of February 28, 2007.
V. Response to Comments
Because of the large number of public comments we normally receive
on Federal Register documents, we are not able to acknowledge or
respond to them individually. We will consider all comments we receive
by the date and time specified in the DATES section of this preamble.
VI. Regulatory Impact Statement
We have examined the impact of this notice as required by Executive
Order 12866 (September 1993, Regulatory Planning and Review), the
Regulatory Flexibility Act (RFA) (September 19, 1980, Pub. L. 96-354),
section 1102(b) of the Social Security Act, the Unfunded Mandates
Reform Act of 1995 (Pub. L. 104-4), and Executive Order 13132.
Executive Order 12866 directs agencies to assess all costs and
benefits of available regulatory alternatives and, if regulation is
necessary, to select regulatory approaches that maximize net benefits
(including potential economic, environmental, public health and safety
effects, distributive impacts, and equity). A regulatory impact
analysis (RIA) must be prepared for major rules with economically
significant effects ($100 million or more in any 1 year). This notice
does not reach the economic threshold and thus is not considered a
major rule.
The RFA requires agencies to analyze options for regulatory relief
of small businesses. For purposes of the RFA, small entities include
small businesses, nonprofit organizations, and small governmental
jurisdictions. Most hospitals and most other providers and suppliers
are small entities, either by nonprofit status or by having revenues of
$6 million to $29 million in any 1 year. Individuals and States are not
included in the definition of a small entity. We are not preparing an
analysis for the RFA because we have determined that this rule will not
have a significant economic impact on a substantial number of small
entities.
In addition, section 1102(b) of the Act requires us to prepare a
regulatory impact analysis if a rule may have a significant impact on
the operations of a substantial number of small rural hospitals. This
analysis must conform to the provisions of section 603 of the RFA. For
purposes of section 1102(b) of the Act, we define a small rural
hospital as a hospital that is located outside of a Core-Based
Statistical Area and Metropolitan Statistical Area and has fewer than
100 beds. We are not preparing an analysis for section 1102(b) of the
Act because we have determined that this notice will not have a
significant impact on the operations of a substantial number of small
rural hospitals.
Section 202 of the Unfunded Mandates Reform Act of 1995 also
requires that agencies assess anticipated costs and benefits before
issuing any rule whose mandates require spending in any 1 year of $100
million in 1995 dollars, updated annually for inflation. That threshold
level is currently approximately $120 million. This notice will have no
consequential effect on State, local, or tribal governments or on the
private sector.
Executive Order 13132 establishes certain requirements that an
agency must meet when it promulgates a proposed rule (and subsequent
final rule) that imposes substantial direct requirement costs on State
and local governments, preempts State law, or otherwise has Federalism
implications. Since this notice does not impose any costs on State or
local governments, the requirements of E.O. 13132 are not applicable.
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: February 9, 2006.
Mark B. McClellan,
Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 06-1646 Filed 2-23-06; 8:45 am]
BILLING CODE 4120-01-P