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-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.

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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-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 486.316(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 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 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 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. 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

[[Page 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.

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Name of facility City State Requested OPO Designated OPO

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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:

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Name of facility City State Requested OPO Designated OPO

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

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

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

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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]

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