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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Care Financing Administration

[BPD-854-NC]

Medicare and Medicaid Programs; Announcement of Applications From

Hospitals Requesting Waivers for Organ Procurement Service Area

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

ACTION: Notice with comment period.

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SUMMARY: In accordance with the Social Security Amendments of 1994,

this notice announces applications received from hospitals requesting

waivers from dealing with their designated area organ procurement

organizations (OPOs). Effective January 1, 1996, a hospital is required

to have an agreement with the OPO designated for the area in which it

is located unless granted a waiver to have an agreement with an

alternative OPO. This notice requests comments from OPOs and the

general public for consideration by us in determining whether such a

waiver should be granted.

DATES: Written comments will be considered if we receive them at the

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

19, 1996.

ADDRESSES: Mail written comments (one original and three copies) to the

following address: Health Care Financing Administration, Department of

Health and Human Services, Attention: BPD-854-NC, P.O. Box 7517,

Baltimore, MD 21244-0517.

[[Page 1390]]

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

and three copies) to one of the following addresses:

Room 309-G, Hubert H. Humphrey Building, 200 Independence Avenue SW.,

Washington, DC 20201, or

Room C5-09-26, 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 BPD-854-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 309-G of

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

DC, on Monday through Friday of each week 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 of the Social Security Act (the Act) provides that a

hospital or rural primary care hospital that participates in the

Medicare or Medicaid programs must establish written protocols for the

identification of potential organ donors. Section 155 of the Social

Security Amendments of 1994 (SSA '94) (Public Law 103-432) amended

section 1138 of the Act to require that effective January 1, 1996, a

hospital may have an agreement concerning organ procurement only with

its designated Organ Procurement Organization (OPO) unless it obtains a

waiver from the Secretary that would allow the hospital to have an

agreement with a different OPO. This section also provides that any

hospital that had an agreement with an out-of-area OPO on the date of

enactment, October 31, 1994, must submit a waiver request to the

Secretary by January 1, 1996, if it wishes to retain the agreement. The

existing agreement would remain in effect pending the Secretary's

determination.

The law further states that in granting a waiver for an out-of-area

agreement, the Secretary must determine that such a waiver: (1) Would

be expected to increase donation; and (2) will assure equitable

treatment of patients referred for transplants within the service area

served by the designated OPO and within the service area served by the

out-of-area OPO. In making a waiver determination, 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 definition of metropolitan

statistical areas (MSA); and (4) the length and continuity of a

hospital's relationship with the out-of-area OPO. Under section

1138(a)(2)(D) of the Act, the Secretary is required to publish a notice

of any waiver applications within 30 days of receiving the application

and offer interested parties an opportunity to comment in writing

within 60 days of the published notice.

II. Hospital Requests for Waiver

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

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

detailed the waiver process and discussed the information that may be

provided by hospitals requesting a waiver. As required by law, we

indicated that upon receipt of the waiver requests, we would publish a

notice to solicit comments.

Upon receipt of the comments, we will review the request and

comments received. During the review process, we may consult on an as

needed basis with parties other than those that submitted comments

including the Public Health Service's Division of Transplantation, the

United Network for Organ Sharing, and HCFA regional offices. If

necessary, we may also request additional clarifying information from

the applying hospital. It should be noted that there is no time limit

upon which we must complete our review. We then will make a

determination on the waiver requests and notify the affected hospitals

and OPOs.

III. Hospitals Requesting Waivers

To date, we have received waiver applications from the following

hospitals:

Hospital Name: West Florida Regional Medical Center

City & State: Pensacola, FL

Requested OPO: Alabama Organ Center

City & State: Birmingham, AL

Designated OPO: University of Florida

City & State: Gainesville, FL

Hospital Name: Singing River Hospital System

City & State: Pascagoula, MS

Requested OPO: Alabama Organ Center

City & State: Birmingham, AL

Designated OPO: Mississippi Organ Recovery Agency

City & State: Jackson, MS

Hospital Name: Jefferson Memorial Hospital

City & State: Ranson, WV

Requested OPO: Virginia's Organ Procurement Agency

City & State: Midlothian, VA

Designated OPO: Center Organ Recovery & Education

City & State: Pittsburgh, PA

Hospital Name: City Hospital

City & State: Martinsburg, WV

Requested OPO: Virginia's Organ Procurement Agency

City & State: Midlothian, VA

Designated OPO: Center Organ Recovery & Education

City & State: Pittsburgh, PA

Hospital Name: Princeton Community Hospital

City & State: Princeton, WV

Requested OPO: Virginia's Organ Procurement Agency

City & State: Midlothian, VA

Designated OPO: Center Organ Recovery & Education

City & State: Pittsburgh, PA

Hospital Name: Fort Walton Beach Medical Center

City & State: Ft. Walton Beach, FL

Requested OPO: Alabama Organ Center

City & State: Birmingham, AL

Designated OPO: University of Florida

City & State: Gainesville, FL

Hospital Name: Baylor Medical Center at Grapevine

City & State: Grapevine, TX

Requested OPO: Southwest Organ Bank

City & State: Dallas, TX

Designated OPO: Life Gift Organ Donation Center

City & State: Houston, TX

Hospital Name: St. Joseph Regional Health Center

City & State: Bryan, TX

Requested OPO: Southwest Organ Bank

City & State: Dallas, TX

Designated OPO: Life Gift Organ Donation Center

City & State: Houston, TX

Authority: Section 1138 of the Social Security Act (42 U.S.C.

1320b-8).

(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: November 30, 1995.

Bruce C. Vladeck,

Administrator, Health Care Financing Administration.

[FR Doc. 96-644 Filed 1-17-96; 8:45 am]

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