Medicare and Medicaid Programs; Announcement of Additional Application From Hospital Requesting Waivers for Organ Procurement Service Area and Technical Correction

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Care Financing Administration

[BPD-879-NC]

Medicare and Medicaid Programs; Announcement of Additional

Application From Hospital Requesting Waivers for Organ Procurement

Service Area and Technical Correction

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

ACTION: Notice with comment period.

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

SUMMARY: This notice announces an additional application which HCFA has

received from a hospital requesting a waiver from dealing with its

designated area organ procurement organization (OPO) in accordance with

section 1138(a)(2) of the Social Security Act. It supplements notices

published in the Federal Register on January 19, 1996 and May 17, 1996,

that announced hospital waiver requests received by HCFA. 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 HCFA grants

it a waiver to have an agreement with an alternative, out-of-area OPO.

This notice requests comments from OPOs and the general public for our

consideration 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,

[[Page 57877]]

no later than 5:00 p.m. on January 7, 1997.

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-879-NC, P.O. Box 7517,

Baltimore, MD 21244-0517.

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.

Comments may also be submitted electronically to the following e-

mail address: [email protected]. E-mail comments must include the

full name and address of the sender and must be submitted to the

referenced addresss in order to be considered. All comments must be

incorporated in the e-mail message because we may not be able to access

attachments. Electronically submitted comments will be available for

public inspection at the Independence Avenue address, below.

Because of staffing and resource limitations, we cannot accept

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

to file code BPD-879-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

On January 19, 1996 and May 17, 1996, we published notices in the

Federal Register (61 FR 1389 and 61 FR 24941) that announced

applications which HCFA had received from hospitals requesting a waiver

from dealing with their designated organ procurement organizations

(OPOs) in accordance with section 1138 (a)(2) of the Social Security

Act (the Act). This notice supplements these two notices and makes a

technical correction to one of the groupings listed in the May 17, 1996

notice.

Section 1138 (a)(1)(A)(iii) 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 Act Amendments of 1994 (SSA '94)

(Public Law 103-432) amended section 1138 of the Act to require that

effective January 1, 1996, a hospital must notify the organ procurement

organization (OPO) designated for the service area in which it is

located of potential organ donors (sections 1138 (a)(1)(A)(iii) and

(a)(1)(B) of the Act). It must also have an agreement to do so only

with that designated OPO (sections 1138 (a)(1)(C) and (a)(3)(A)).

The statute also provides that the hospital may obtain a waiver of

these requirements from the Secretary. A waiver would allow the

hospital to have an agreement with an ``out-of-area'' OPO (section 1138

(a)(2)) if it meets conditions specified in the statute (sections 1138

(a)(2)(A) (i) and (ii)).

The law further states that in granting a waiver, 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 (section 1138

(a)(2)(A)). 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 the definition of metropolitan

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

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

1138(a)(2)(B)). 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. Section 155(a)(2) of SSA '94 provides that any hospital that

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

that legislation, October 31, 1994, may obtain a temporary or interim

waiver of the requirements of sections 1138(a)(1)(A)(iii) and

(a)(l)(C). The statute requires that the hospital must have submitted a

waiver request to the Secretary by January 1, 1996. The statute

specifically provides that the hospital's existing agreement with the

out-of-area OPO would remain in effect pending the Secretary's final

determination under section 1138(a)(2) as to whether the hospital

should be granted a permanent waiver.

For hospitals that do not meet these conditions, but that entered

into agreements with out-of-area OPOs prior to January 1996, we have

established a similar process. Under our section 1138(a)(2) authority

to grant waivers if statutory conditions are met, we will make a

preliminary determination as to whether the hospital's request meets

the requirements of section 1138(a)(2)(A)(i) and (ii) based upon an

initial review of its waiver request. If we determine that the hospital

appears preliminarily to meet those standards, we will grant the

hospital a temporary, interim waiver while we consider further the

merits of the hospital's waiver request on a permanent basis. In the

meantime, the hospital may continue its relationship with the OPO with

which it has an agreement.

II. Waiver Request Procedures

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. We indicated that upon

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

notice to solicit public comments, as required by law (section

1138(a)(2)(D)).

We will then review the requests and comments received. During the

review process, we may consult on an as-needed basis with agencies

outside HCFA, including the Public Health Service's Division of

Transplantation, the United Network for Organ Sharing, and HCFA

regional offices. If necessary, we may request additional clarifying

information from the applying hospital or others. We then will make a

final determination on the waiver requests and notify the affected

hospitals and OPOs.

III. Additional Hospital Waiver Request

This notice adds an additional hospital to the May 17, 1996 notice.

We are adding the Hutcheson Medical Center, Inc. of Fort Oglethorpe,

GA. The Hutcheson Medical Center currently designated area OPO is

Tennessee Donor Services (TNDS), 1714 Hayes Street, Nashville, TN

37203. The center's requested out-of-area OPO is Lifelink of Georgia

(GALL), 3715 Northside Parkway, 100 Northcreek, Suite 300, Atlanta, GA

30327.

IV. Technical Corrections

In the May 17, 1996, notice with comment period on page 24943, in

the Group I listing, we inadvertently carried the incorrect requested

OPO code for

[[Page 57878]]

Mercy Hospital. The corrected entries for this hospital read as

follows:

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

Name of facility City State Requested OPO Designated OPO

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

Mercy Hospital.................. Willard............ OH............ OHLC................ OHLB

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

Key:

OHLC Life Connection of Ohio, 1545 Holland Road, Suite C, Maumme, OH 43537.

OHLB Lifebanc, 20600 Chagrin Blvd., Suite 350, Cleveland, OH 44122.

In the Group II listing, on page 24944, we inadvertently carried

the incorrect code for the requested OPO and the designated OPO for New

Milford Hospital. The corrected entries for this hospital read as

follows:

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

Name of facility City State Requested OPO Designated OPO

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

New Milford Hospital............ New Milford........ CT............ NYRT................ CTHH

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

Key:

NYRT New York Regional Transplant Program, 475 Riverside Drive-Suite 1244, New York, NY 10115.

CTHH Northeast OPO and Tissue Bank, Hartford Hospital, 80 Seymour Street, Hartford, CT 06102-5037.

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: September 20, 1996.

Thomas A. Ault,

Director, Bureau of Policy Development, Health Care Financing

Administration.

[FR Doc. 96-28684 Filed 11-7-96; 8:45 am]

BILLING CODE 4120-01-P