Medicare and Medicaid Programs; Announcement of Application From Hospital Requesting Waiver for Organ Procurement Service Area, 60703-60704 [2012-24496]

Download as PDF Federal Register / Vol. 77, No. 193 / Thursday, October 4, 2012 / Notices must be received at the Reserve Bank indicated or the offices of the Board of Governors not later than October 29, 2012. A. Federal Reserve Bank of Chicago (Colette A. Fried, Assistant Vice President) 230 South LaSalle Street, Chicago, Illinois 60690–1414: 1. Wintrust Financial Corporation, Rosemont, Illinois; to acquire 100 percent of the voting shares of HPK Financial Corporation, and thereby indirectly acquire voting shares of Hyde Park Bank & Trust Company, both in Chicago, Illinois. B. Federal Reserve Bank of Minneapolis (Jacqueline G. King, Community Affairs Officer) 90 Hennepin Avenue, Minneapolis, Minnesota 55480–0291: 1. Forstrom Bancorporation, Inc., Clara City, Minnesota; to acquire 100 percent of the voting shares of Murdock Bancor, Inc., Mendota Heights, Minnesota, and thereby indirectly acquire voting shares of First State Bank of Murdock, Murdock, Minnesota. C. 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[FR Doc. 2012–24503 Filed 10–3–12; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [CMS–1453–NC] Medicare and Medicaid Programs; Announcement of Application From Hospital Requesting Waiver for Organ Procurement Service Area Centers for Medicare & Medicaid Services (CMS), HHS. ACTION: Notice with comment period. AGENCY: This notice with comment period announces a hospital’s request for a waiver from the requirement to have an agreement with its designated Organ Procurement Organization (OPO). The request was made in accordance with section 1138(a)(2) of the Social Security Act (the Act). In addition, this notice requests comments from OPOs and the general public for our consideration in determining whether we should grant the requested waiver. DATES: Comment Date: To be assured consideration, comments must be received at one of the addresses provided below, no later than 5 p.m. on December 3, 2012. ADDRESSES: In commenting, please refer to file code CMS–1453–NC. Because of staff and resource limitations, we cannot accept comments by facsimile (FAX) transmission. You may submit comments in one of four ways (please choose only one of the ways listed): 1. Electronically. You may submit electronic comments on this regulation to https://www.regulations.gov. Follow the instructions under the ‘‘More Search Options’’ tab. 2. By regular mail. You may mail written comments to the following address ONLY: Centers for Medicare & Medicaid Services, Department of Health and SUMMARY: PO 00000 Frm 00033 Fmt 4703 Sfmt 4703 60703 Human Services, Attention: CMS– 1453–NC, P.O. Box 8010, Baltimore, MD 21244–1850. 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 to the following address ONLY: Department of Health and Human Services, Attention: CMS–1453–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 before the close of the comment period to either of the following addresses: a. For delivery in Washington, DC— Centers for Medicare & Medicaid Services, Department of Health and Human Services, Room 445–G, Hubert H. Humphrey Building, 200 Independence Avenue SW., Washington, DC 20201. (Because access to the interior of the Hubert H. Humphrey 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.) b. For delivery in Baltimore, MD— Centers for Medicare & Medicaid Services, Department of Health and Human Services, 7500 Security Boulevard, Baltimore, MD 21244– 1850. 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. 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: Patricia Taft, (410) 786–4561. SUPPLEMENTARY INFORMATION: 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. We post all comments E:\FR\FM\04OCN1.SGM 04OCN1 60704 Federal Register / Vol. 77, No. 193 / Thursday, October 4, 2012 / Notices emcdonald on DSK67QTVN1PROD with NOTICES received before the close of the comment period on the following Web site as soon as possible after they have been received: https:// www.regulations.gov. Follow the search instructions on that Web site to view public comments. Comments received timely will also 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 are responsible for the procurement, preservation, and transport of transplantable organs to transplant centers throughout the country. Qualified OPOs are designated by the Centers for Medicare & Medicaid Services (CMS) to recover or procure organs in CMS-defined exclusive geographic service areas, pursuant to section 371(b)(1) of the Public Health Service Act (42 U.S.C. 273(b)(1) and our regulations at 42 CFR § 486.306. 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, pursuant to section 1138(a)(1)(C) 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)(A) 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)(A) 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 VerDate Mar<15>2010 15:21 Oct 03, 2012 Jkt 229001 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 changes made in definitions for metropolitan statistical areas; 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 received from a hospital 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 § 486.308(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 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 Health Resources and Services Administration’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 § 486.308(e), the following hospital has requested a waiver in order to enter into an agreement with a designated OPO other than the OPO designated for the service area in which the hospital is located: PO 00000 Frm 00034 Fmt 4703 Sfmt 4703 Quitman County Hospital, LLC. of Marks, Mississippi, is requesting a waiver to work with: Mississippi Organ Recovery Agency, 4400 Lakeland Drive, Flowood, MS 39232. The Hospital’s Designated OPO is: Mid-South Transplant Foundation, Inc., 8001 Centerview Parkway, Suite 302, Memphis, TN 38018. (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: September 28, 2012. Marilyn Tavenner, Acting Administrator and Chief Operating Officer, Centers for Medicare & Medicaid Services. [FR Doc. 2012–24496 Filed 10–3–12; 8:45 am] BILLING CODE 4120–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA–2012–M–0371, FDA– 2012–M–0372, FDA–2012–M–0373, FDA– 2012–M–0390, FDA–2012–M–0407, FDA– 2012–M–0562, and FDA–2012–M–0638] Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is publishing a list of premarket approval applications (PMAs) that have been approved. This list is intended to inform the public of the availability of safety and effectiveness summaries of approved PMAs through the Internet and the Agency’s Division of Dockets Management. ADDRESSES: Submit written requests for copies of summaries of safety and effectiveness data to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Please cite the appropriate docket number as listed in table 1 of this document when submitting a written request. See the SUPPLEMENTARY INFORMATION section for electronic access to the summaries of safety and effectiveness. FOR FURTHER INFORMATION CONTACT: Nicole Wolanski, Center for Devices and Radiological Health, Food and Drug SUMMARY: E:\FR\FM\04OCN1.SGM 04OCN1

Agencies

[Federal Register Volume 77, Number 193 (Thursday, October 4, 2012)]
[Notices]
[Pages 60703-60704]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-24496]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-1453-NC]


Medicare and Medicaid Programs; Announcement of Application From 
Hospital Requesting Waiver for Organ Procurement Service Area

AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.

ACTION: Notice with comment period.

-----------------------------------------------------------------------

SUMMARY: This notice with comment period announces a hospital's request 
for a waiver from the requirement to have an agreement with its 
designated Organ Procurement Organization (OPO). The request was made 
in accordance with section 1138(a)(2) of the Social Security Act (the 
Act). In addition, this notice requests comments from OPOs and the 
general public for our consideration in determining whether we should 
grant the requested waiver.

DATES: Comment Date: To be assured consideration, comments must be 
received at one of the addresses provided below, no later than 5 p.m. 
on December 3, 2012.

ADDRESSES: In commenting, please refer to file code CMS-1453-NC. 
Because of staff and resource limitations, we cannot accept comments by 
facsimile (FAX) transmission.
    You may submit comments in one of four ways (please choose only one 
of the ways listed):
    1. Electronically. You may submit electronic comments on this 
regulation to https://www.regulations.gov. Follow the instructions under 
the ``More Search Options'' tab.
    2. By regular mail. You may mail written comments to the following 
address ONLY:

Centers for Medicare & Medicaid Services, Department of Health and 
Human Services, Attention: CMS-1453-NC, P.O. Box 8010, Baltimore, MD 
21244-1850.

    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 to 
the following address ONLY:

Department of Health and Human Services, Attention: CMS-1453-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 before the close of the comment period 
to either of the following addresses:
    a. For delivery in Washington, DC--

Centers for Medicare & Medicaid Services, Department of Health and 
Human Services, Room 445-G, Hubert H. Humphrey Building, 200 
Independence Avenue SW., Washington, DC 20201.

    (Because access to the interior of the Hubert H. Humphrey 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.)
    b. For delivery in Baltimore, MD--

Centers for Medicare & Medicaid Services, Department of Health and 
Human Services, 7500 Security Boulevard, Baltimore, MD 21244-1850.

    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.
    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: Patricia Taft, (410) 786-4561.

SUPPLEMENTARY INFORMATION: 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. We 
post all comments

[[Page 60704]]

received before the close of the comment period on the following Web 
site as soon as possible after they have been received: https://www.regulations.gov. Follow the search instructions on that Web site to 
view public comments.
    Comments received timely will also 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 are responsible for the procurement, preservation, 
and transport of transplantable organs to transplant centers throughout 
the country. Qualified OPOs are designated by the Centers for Medicare 
& Medicaid Services (CMS) to recover or procure organs in CMS-defined 
exclusive geographic service areas, pursuant to section 371(b)(1) of 
the Public Health Service Act (42 U.S.C. 273(b)(1) and our regulations 
at 42 CFR Sec.  486.306. 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, 
pursuant to section 1138(a)(1)(C) 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)(A) 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)(A) 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 changes made 
in definitions for metropolitan statistical areas; 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 
received from a hospital 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 Sec.  486.308(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 
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 Health Resources and Services Administration'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 Sec.  486.308(e), the following hospital has 
requested a waiver in order to enter into an agreement with a 
designated OPO other than the OPO designated for the service area in 
which the hospital is located:
    Quitman County Hospital, LLC. of Marks, Mississippi, is requesting 
a waiver to work with:

Mississippi Organ Recovery Agency, 4400 Lakeland Drive, Flowood, MS 
39232.

    The Hospital's Designated OPO is:

Mid-South Transplant Foundation, Inc., 8001 Centerview Parkway, Suite 
302, Memphis, TN 38018.

(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: September 28, 2012.
Marilyn Tavenner,
Acting Administrator and Chief Operating Officer, Centers for Medicare 
& Medicaid Services.
[FR Doc. 2012-24496 Filed 10-3-12; 8:45 am]
BILLING CODE 4120-01-P
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