01-8070. Proposed Collection; Comment Request

AGENCY:

Office of the Assistant Secretary of Defense Health Affairs, DoD.

ACTION:

Notice.

In accordance with section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Office of the Assistant Secretary of Defense for Health Affairs announces the proposed public information collection and seeks public comment on the provisions thereof. Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the information collection; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the information collection on respondents, including through the use of automated collection techniques or other forms of information technology.

DATES:

Consideration will be given to all comments received June 4, 2001.

ADDRESSES:

Written comments and recommendations on the information collection should be sent to TRICARE Management Activity, Medical Benefits and Reimbursement Systems, 16401 East Centretech Parkway, ATTN: Marty Maxey, Aurora, CO 80011-9066.

FOR FURTHER INFORMATION CONTACT:

To request more information on this proposed information collection, please write to the above address or call TRICARE Management Activity, Medical Benefits and Reimbursement Systems, at [phone].

Title of Information Collection: Criteria for TRICARE/CHAMPUS Coverage of Organ Transplantation.

Needs and Uses: TRICARE/CHAMPUS participating hospitals must file a narrative application to be approved for coverage and payment of organ transplants performed on TRICARE/CHAMPUS beneficiaries.

Affected Public: Business or other for profit.

Annual Burden Hours: 100.

Number of Respondents: 1.

Responses per Respondent: 1.

Average Burden per Response: 100 hours.

Frequency: Collected at the time of initial application. A facility that wishes to obtain TRICARE/CHAMPUS coverage for organ transplantation shall submit a narrative application for approval and, once approved, report events or changes that would affect its approved status.

SUPPLEMENTARY INFORMATION:

Summary of Information Collection

TRICARE Management Activity (TMA), formerly known as OCHAMPUS, is in the process of submitting a final rule for publication in the Federal Register, clarifying coverage of organ transplants. 32 CFR Part 199(e)(5) allows coverage for organ transplant procedures provided the procedure is in accordance with accepted professional medical standards and is not considered unproven. In the case of organ transplantation, we believe many other factors are related to the safety and efficacy of the transplant. Thus, coverage of organ transplantation requires detailed criteria to identify the context in which organ transplantation can be considered medically reasonable and necessary. The requested information is needed to ensure a hospital meets the criteria to qualify for CHAMPUS coverage and payment of transplants performed by the facility.

If a facility is a Medicare approved transplant center, TRICARE/CHAMPUS recognizes the facility as a TRICARE/CHAMPUS approved center for the specific organ for which the facility has received approval. If a facility is not Medicare approved, the hospital must provide information on patient selection, patient management, commitment, facility plans, experience and survival rates, maintenance of data, organ procurement, laboratory procedures and billing when it applies to TRICARE/CHAMPUS for a coverage determination.

This notice contains information collection requirements that are subject to the Office of Management and Budget approval under the Paperwork Reduction Act of 1980. The information collection concerns the requirement that a facility that wishes to obtain TRICARE/CHAMPUS coverage for organ transplantation submit an application for approval and, once approved, report events or changes that would affect its approved status. Public reporting burden for this collection of information is expected to be 100 hours.

There are no strict formats facilities must use in applying for coverage. The application is primarily narrative and has no standard format.

Dated: March 22, 2001.

Patricia Toppings,

Alternate Federal Register Liaison Officer, Department of Defense.