48872 Federal Register / Vol. 62, No. 180 / Wednesday, September 17, 1997 / Notices

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

[BPD–898–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.

SUMMARY: This notice announces six

additional applications that HCFA has

received from hospitals requesting

waivers from dealing with their

designated organ procurement

organizations (OPOs) in accordance

with section 1138(a)(2) of the Act. It

supplements notices published in the

Federal Register on January 19, 1996,

May 17, 1996, November 8, 1996, and

April 21, 1997, 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. This

notice also makes a technical correction

to two of the listings in the April 21,

1997 notice.

DATES: Written comments will be

considered if we receive them at the

appropriate address, as provided below,

no later than 5:00 p.m. on November 17

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–898–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–898–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. Honey, (410) 786–4554.

SUPPLEMENTARY INFORMATION:

I. Background

On January 19, 1996, May 17, 1996,

November 8, 1996, and April 21, 1997,

we published notices in the Federal

Register (61 FR 1389, 61 FR 24941, 61

FR 57876, and 62 FR 19326) 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 four notices. Section

1138(a)(1)(A)(iii) of 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 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-ofarea 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 486.316(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

§ 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 HCFA is

processing the waiver request.

Earlier this year HCFA redesignated

all OPO service areas as a result of the

2-year recertification process required

under the statute and regulations at

§ 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 asneeded 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 § 486.316(e), the

following six 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 redesignation of OPO service

areas earlier this year. The listing

includes the name of the facility, the

city and State location of the facility, the
Federal Register / Vol. 62, No. 180 / Wednesday, September 17, 1997 / Notices 48873

requested OPO, and the currently

designated area OPO. These hospitals

have submitted timely waiver requests

and may work with the requested OPO

rather than the designated OPO pending

our review.

Name of facility City State Requested

OPO

Designated

OPO

Alamance Regional Medical Center ................................ Burlington ....................................................... NC NCNC NCBG

Bullhead Community Hospital .......................................... Bullhead City .................................................. AZ AZOB NVLV

Cooley Dickinson Hospital Inc ......................................... Northhampton ................................................ MA MAOB CTHH

Ohio Valley Medical Center ............................................. Wheeling ........................................................ WV PATF OHLP

Reynolds Memorial Hospital ............................................ Glen Dale ....................................................... WV PATF OHLP

Wheeling Hospital ............................................................ Wheeling ........................................................ WV PATF OHLP

IV. Technical Correction

In the April 21, 1997, notice with comment period at 62 FR 19328, in the first chart, the listings of the OPO

codes of the requested and designated OPOs for Crestline Memorial Hospital and River Valley Health System were

inadvertently reversed. The corrected entries for these hospitals read as follows:

Name of facility City State Requested

OPO

Designated

OPO

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

Crestline Memorial Hospital ............................................. Crestline ......................................................... OH OHLP OHLC

V. 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

KYDA—KENTUCKY ORGAN DONOR

AFFILIATES, 105 East Broadway,

Louisville, KY 40202

MAOB—NEW ENGLAND ORGAN

BANK, INC., One Gateway Center,

Newton, MA 02158

NCBG—CAROLINA LIFE CARE, North

Carolina Baptist Hospitals, Medical

Center Boulevard, Winston-Salem, NC

27157

NCNC—CAROLINA ORGAN

PROCUREMENT, 702 Johns Hopkins

Drive, Greenville, NC 27834

NVLV—NEVADA DONOR NETWORK,

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

PATF—CENTER FOR ORGAN

RECOVERY AND EDUCATION, 204

Sigma Drive, RIDC Park, Pittsburgh,

PA 15238.

VI. 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 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 an 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; Program No. 93.774 Medicare—

Supplementary Medical Insurance, and

Program No. 93.778, Medical Assistance

Program)

Dated: September 2, 1997.

Bruce M. Fried,

Director, Center for Health Plans and

Providers, Health Care Financing

Administration.

[FR Doc. 97–24644 Filed 9–16–97; 8:45 am]

BILLING CODE 4120–01–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Office of Inspector General

Program Exclusions: December 1996

AGENCY: Office of Inspector General,

HHS.

ACTION: Notice of program exclusions.

During the month of December 1996,

the HHS Office of Inspector General

imposed exclusions in the cases set

forth below. When an exclusion is

imposed, no program payment is made

to anyone for any items or services

(other than an emergency item or

service not provided in a hospital

emergency room) furnished, ordered or

prescribed by an excluded party under

the Medicare, Medicaid, Maternal and

Child Health Services Block Grant and

Block Grants to States for Social

Services programs. In addition, no

program payment is made to any

business or facility, e.g., a hospital, that

submits bills for payment for items or

services provided by an excluded party.

Program beneficiaries remain free to

decide for themselves whether they will

continue to use the services of an