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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Care Financing Administration

[BPD-894-NC]

Medicare and Medicaid Programs; Announcement of Additional

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: This notice announces eight additional applications that HCFA

has received from hospitals requesting waivers from dealing with their

designated organ procurement organizations (OPOs) in accordance

[[Page 19327]]

with section 1138(a)(2) of the Act. It supplements notices published in

the Federal Register on January 19, 1996, May 17, 1996, and November 8,

1996, that announced hospital waiver requests received by HCFA. This

notice requests comments from OPOs and the general public for our

consideration in determining whether these waivers 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 June

20, 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-894-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.

Because of staffing and resource limitations, we cannot accept

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

to file code BPD-894-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, May 17, 1996, and November 8, 1996, we

published notices in the Federal Register (61 FR 1389, 61 FR 24941, and

61 FR 57876) 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 three notices. 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)

(Pub. L. 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)(3)(B) of the Act). The hospital 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 (section

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.

Regulations at 42 CFR 486.318(d) provide that if HCFA changes 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 will use to evaluate the waiver in these

cases are the same as that described above under section 1138(a)(2)(A)

of the Act and incorporated in the regulations at Sec. 486.318(e). The

regulations further specify that a hospital may continue to operate

under its existing agreement with an out-of-area OPO while HCFA is

processing the waiver request.

HCFA recently redesignated all OPO service areas as a result of the

2-year recertification process required under the statute and

regulations at Sec. 486.304(e)(2).

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

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 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 the HCFA Central Office, 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 Requests

As allowed under Sec. 483.316(d), the following seven hospitals

have requested waivers to have an agreement with an alternative, out-

of-area OPO, as a result of changes in their designated OPOs due to the

recent redesignation of OPO service areas. The listing includes the

name of the facility, the city and State location of the facility, the

requested OPO, and the currently designated area OPO. These hospitals

have submitted timely waiver requests and may work on an interim basis

with the requested out-of-area OPO, pending receipt of public comments

and our final determination.

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Name of facility City State Requested OPO Designated OPO

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Wing Memorial Hospital.......... Palmer............. MA MAOB CTHH

[[Page 19328]]

Noble Memorial Hospital......... Westfield.......... MA MAOB CTHH

Holyoke Hospital................ Holyoke............ MA MAOB CTHH

Crestline Memorial Hosptial..... Crestline.......... OH OHLC OHLP

River Valley Health System...... Ironton............ OH KYDA OHLP

Samaritan Health System......... Lake Havasu........ AZ AZOB NVLV

Kingman Regional Medical Center. Kingman............ AZ AZOB NVLV

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In addition, the following hospital has requested a waiver that is

unrelated to changes made as a result of recent redesignations of OPO

service areas. This hospital's request was made on a prospective basis.

Therefore, our determination on this request will be made only upon

receipt of public comments and completion of our review. Any approval

of this request will be prospective.

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Name of facility City State Requested OPO Designated OPO

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Hutcheson Medical Center........ Fort Oglethorpe.... GA GALL TNDS

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IV. Keys to the OPO Codes

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

their addresses are as follows:

AZOB

DONOR NETWORK OF ARIZONA, 3877 North Seventh Street, Phoenix, AZ

85014

CTHH NORTHEAST OPO AND TISSUE BANK, Hartford Hospital, 80 Seymour

Street, Hartford, CT 06102-5037

GALL LIFELINK OF GEORGIA, 3715 Northside Parkway, 100 Northcreek, Suite

300, Atlanta, GA 30327

KYDA

KENTUCKY ORGAN DONOR AFFILIATES, 105 East Broadway, Louisville, KY

40202

MAOB

NEW ENGLAND ORGAN BANK, One Gateway Center, Newton, MA 02158

NVLV

NEVADA DONOR NEWTWORK, 4580 Southeastern Avenue, Suite 33, Las

Vegas, NV 89119

OHLC

LIFE CONNECTION OF OHIO, 1545 Holland Road, Suite C, Maumee, OH

43537

OHLP

LIFELINE OF OHIO, 770 Kinnear Road, Suite 200, Columbus, OH 43212

TNDS

TENNESSEE DONOR SERVICES, 1714 Hayes Street, Nashville, TN 37203

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 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 to be

collected.

The information collection requirement and the burden associated

with requiring a Medicare or Medicaid participating hospital to have an

agreement with the OPO designated for its area or to submit a waiver

request to HCFA for approval to have an agreement with a designed OPO

other than the OPO designated for its service area currently are

approved under OMB approval number 0938-0688 (HCFA-R-13), with an

expiration date of November 30, 1997.

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; and Program No. 93.774, and No.

93.778, Medical Assistance Program)

Dated: March 21, 1997.

Barbara Wynn,

Acting Director, Bureau of Policy Development, Health Care Financing

Administration.

[FR Doc. 97-10144 Filed 4-18-97; 8:45 am]

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