Medicare and Medicaid Programs; Announcement of Additional Applications From Hospitals Requesting Waivers for Organ Procurement Service Areas

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Care Financing Administration

[HCFA-1055-NC]

Medicare and Medicaid Programs; Announcement of Additional

Applications From Hospitals Requesting Waivers for Organ Procurement

Service Areas

AGENCY: Health Care Financing Administration (HCFA), HHS.

ACTION: Notice with comment period.

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

SUMMARY: This notice announces additional applications that we have

received from hospitals requesting waivers from entering into

agreements with their designated organ procurement organizations.

Section 1138(a)(2) of the Social Security Act allows the Secretary of

the Department of Health and Human Services to grant waivers to

hospitals that want to enter into an agreement with a specific OPO that

is not the designated OPO for the hospital's service area. This notice

requests comments from OPOs and the general public for our

consideration in determining whether these waivers should be granted.

COMMENT DATE: Comments will be considered if we receive them at the

appropriate address, as provided below, no later than 5 p.m. on October

8, 1999.

ADDRESSES: Mail written comments (1 original and 3 copies) to the

following address: Health Care Financing Administration, Department of

Health

[[Page 43199]]

and Human Services, Attention: HCFA-1055-NC, P.O. Box 9016, Baltimore,

MD 21244-9016.

If you prefer, you may deliver your written comments (1 original

and 3 copies) to one of the following addresses:

Room 443-G, Hubert H. Humphrey Building, 200 Independence Avenue, SW.,

Washington, DC 20201, or

Room C5-14-03, 7500 Security Boulevard, Baltimore, MD 21244-1850.

Because of staffing and resource limitations, we cannot accept

comments by facsimile (FAX) transmission. In commenting, please refer

to file code HCFA-1055-NC. Comments received timely will be available

for public inspection as they are received, generally beginning

approximately 3 weeks after publication of a document, in Room 443-G of

the Department's offices at 200 Independence Avenue, SW., Washington,

DC, Monday through Friday from 8:30 a.m. to 5 p.m. (phone: (202) 690-

7890).

FOR FURTHER INFORMATION CONTACT: Mark A. Horney, (410) 786-4554.

SUPPLEMENTARY INFORMATION:

I. Background

Section 1138(a)(1)(A)(iii) of the Social Security Act (the Act)

provides that a participating hospital must notify its designated organ

procurement organization (OPO) of potential organ donors. The

designated OPO, as defined under section 1138(a)(3)(B) of the Act, is

determined by the service area in which the hospital is located. Under

section 1138(a)(1)(C) of the Act, the hospital must have an agreement

with only that designated OPO to identify potential organ donors.

Section 1138(a)(2) of the Act provides that a participating

hospital may obtain a waiver of these requirements from the Secretary

of the Department of Health and Human Services (the Secretary). A

waiver allows the hospital to have an agreement with an OPO other than

the designated OPO if the conditions specified in section 1138(a)(2)(A)

of the Act are met.

Section 1138(a)(2)(A) 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

hospital's 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 service area due to the

changes made on or after December 28, 1992, in definition of

metropolitan statistical areas (MSAs); and (4) the length and

continuity of a hospital's relationship with the OPO other than the

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 offer interested parties an opportunity

to comment in writing within 60 days of the published notice.

The regulations at 42 CFR 486.316(d) provide that if we change the

OPO designated for an area, hospitals located in that area must enter

into agreements with the newly designated OPO or submit a request for a

waiver within 30 days of notice of the change in designation. The

criteria that the Secretary uses to evaluate the waiver in these cases

are the same as those described above under section 1138(a)(2)(A) of

the Act and have been incorporated into the regulations at

Sec. 486.316(e). Section 486.316(g) further specifies that a hospital

may continue to operate under its existing agreement with an out-of-

area OPO while we process its waiver request it submitted in accordance

with Sec. 486.316(d).

This notice supplements previous notices announcing OPO waivers

published in the Federal Register on January 19, 1996 (61 FR 1389), May

17, 1996 (61 FR 24941), November 8, 1996 (61 FR 57876), April 21, 1997

(62 FR 19326), September 17, 1997 (62 FR 48872), September 23, 1998 (63

FR 50919), and January 12, 1999 (64 FR 1811).

II. Waiver Request Procedures

In October 1995, we issued a Program Memorandum (Transmittal No. A-

95-11) that was supplied to each hospital. This Program Memorandum

detailed the waiver process and discussed the information that

hospitals must provide in requesting a waiver. We indicated that upon

receipt of the waiver requests, we would publish a Federal Register

notice to solicit public comments, as required by section 1138(a)(2)(D)

of the Act.

We will review the requests 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 Organ Procurement and Transplantation Network Contractor, 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 requests and notify the affected hospitals and OPOs.

III. Hospital Waiver Requests

As allowed under Sec. 486.316(e), each of the following hospitals

has requested a waiver to have an agreement with an alternative, out-

of-area OPO. The listing includes the name of the facility, the city

and state of the facility, the currently designated area OPO and the

requested OPO.

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

Name of facility City State Designated OPO Requested OPO

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

Keweenaw Memorial Hospital...... Laurium............ MI WIWU MIOP

Jefferson Memorial Hospital..... Ranson............. WV DCTC VAOP

Dickinson County Healthcare Iron Mountain...... MI WIWU MIOP

System.

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

The following two hospitals have requested a waiver under

Sec. 486.316 (e) for a reason unrelated to a change in the designated

service area of an OPO. These waivers will only be effective upon

completion of our review if the provider meets the requirement of

Sec. 486.316 (e).

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

Name of facility City State Designated OPO Requested OPO

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

Fairview Hospital............... Great Barrington... MA MAOB NYAP

Elko General Hospital........... Elko............... NV NVLV UTOP

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

[[Page 43200]]

IV. Key to the OPO Codes

The key to the acronyms used in the listings to identify OPOs and

their addresses are as follows:

DCTC--WASHINGTON REGIONAL TRANSPLANT CONSORTIUM, 8110 Gatehouse Road,

Suite 101 W, Falls Church, VA 22042

MAOB--NEW ENGLAND ORGAN BANK, One Gateway Center, Newton, MA 02458

MIOP--ORGAN PROCUREMENT AGENCY OF MICHIGAN, 2203 Platt Road, Ann Arbor,

MI 48104

NVLV--NEVADA DONOR NETWORK, 4850 Southeastern Avenue, Suite 33, Las

Vegas, NV 89119

NYAP--CENTER FOR DONATION AND TRANSPLANT, 218 Great Oaks Blvd., Albany,

NY 12203

UTOP--INTERMOUNTAIN ORGAN PROCUREMENT AGENCY, 230 South 500 East, Suite

290, Salt Lake City, UT 84102

VAOP--VIRGINIA ORGAN PROCUREMENT AGENCY, 1527 Houguenot Road,

Midlothian, VA 23113

WIWU--UNIVERSITY OF WISCONSIN OPO, University of Wisconsin Hospitals

and Clinics, 600 Highland Avenue, Madison, Wisconsin 53792

V. Collection of Information Requirements

Under the Paperwork Reduction Act of 1995, we are required to

provide 60-day notice in the Federal Register and solicit public

comment before a collection of information requirement is submitted to

the Office of Management and Budget (OMB) for review and approval. In

order to fairly evaluate whether an information collection requirement

should be approved by OMB, section 3506(c)(2)(A) of the Paperwork

Reduction Act of 1995 requires that we solicit comment on the following

issues:

The need for the information collection and its usefulness

in carrying out the proper functions of our agency.

The accuracy of our estimate of the information collection

burden.

The quality, utility, and clarity of the information to be

collected.

Recommendations to minimize the information collection

burden on the affected public, including automated collection

techniques.

Therefore, we are soliciting public comment on the following issue

for the information collection requirements described below.

Designation of one OPO for each service area:

Section 486.316(e) states the requirements for a Medicare or

Medicaid participating hospital to qualify for a waiver permitting the

hospital to have an agreement with a designated OPO other than the OPO

designated for the service area in which the hospital is located. The

burden associated with these requirements is currently approved under

OMB 0938-0688, HCFA-R-13, Conditions of Coverage for Organ Procurement

Organizations, with an expiration date of November 30, 1999.

If you comment on any of these information collection and

recordkeeping requirements, please mail copies directly to the

following:

Health Care Financing Administration, Office of Information Services,

Security and Standards Groups, Division of HCFA Enterprise Standards,

Attention: Louis Blank, HCFA-1055-NC, Room N2-14-26, 7500 Security

Boulevard, Baltimore, MD 21244-1850, and

Office of Information and Regulatory Affairs, Office of Management and

Budget, Attention: Allison Eydt, HCFA Desk Officer, Room 10235, New

Executive Office Building, Washington, DC 20503.

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 2, 1999.

Robert A. Berenson,

Director, Center for Health Plans and Providers, Health Care Financing

Administration.

[FR Doc. 99-20403 Filed 8-6-99; 8:45 am]

BILLING CODE 4120-01-P