Federal Register / Vol. 62, No. 220 / Friday, November 14, 1997 / Proposed Rules 61057

name] or other pain relievers. [Product

name] may increase your risk of liver

damage and stomach bleeding.’’

(b) Requirements to supplement

approved application. Holders of

approved applications for OTC drug

products that contain internal analgesic/

antipyretic active ingredients that are

subject to the requirements of paragraph

(a) of this section must submit

supplements under § 314.70(c) of this

chapter to include the required warning

in the product’s labeling. Such labeling

may be put into use without advance

approval of FDA provided it includes at

least the information included in

paragraph (a) of this section.

(c) Any drug product subject to this

section that is not labeled as required

and that is initially introduced or

initially delivered for introduction into

interstate commerce after (date 6

months after

date of publication of the final rule in

the Federal Register), is misbranded

under section 502 of the Federal Food,

Drug, and Cosmetic Act and is subject

to regulatory action.

Dated: August 20, 1997.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 97–30035 Filed 11–13–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF THE INTERIOR

Bureau of Indian Affairs

25 CFR Part 11

RIN 1076–AD76

Law and Order on Indian Reservations;

Correction

AGENCY: Bureau of Indian Affairs,

Interior.

ACTION: Correction to proposed

regulations.

SUMMARY: This document contains

corrections to the proposed regulations

which were published Friday, July 5,

1996 (61 FR 35158) and corrections to

the proposed regulations which were

published Wednesday, February 26,

1997 (62 FR 8665). The proposed rule

amends regulations governing Courts of

Indian Offenses.

DATES: Comments must be received on

or before December 15, 1997.

ADDRESSES: Comments are to be mailed

to Bettie Rushing, Office of Tribal

Services, Bureau of Indian Affairs, 1849

C Street, NW, MS 4641–MIB,

Washington, DC 20240; or, hand

delivered to Room 4641 at the same

address.

FOR FURTHER INFORMATION CONTACT:

Bettie Rushing, Bureau of Indian Affairs

(202) 208–4400.

SUPPLEMENTARY INFORMATION:

Background

The proposed rule that is the subject

of these corrections supersedes 25 CFR

11.100(a) and affects those tribes that

have exercised their inherent

sovereignty by removing the names of

those tribes from the list of Courts of

Indian Offenses.

The Assistant Secretary-Indian

Affairs, or her designee, has received

law and order code adopted by the

Confederated Tribes of the Goshute

Reservation of Nevada in accordance

with their constitutions and by-laws and

approved by the appropriate bureau

official. The Assistant Secretary-Indian

Affairs recognizes that this court was

established in accordance with the

tribe’s constitutions and by-laws. Also,

the list of Courts of Indian Offenses has

been corrected to include tribes

inadvertently omitted from the

correction and to reflect the decision of

the Court in Fletcher v. United States,

No. 95–5208 (10th Cir. Dec. June 10,

1997, reh. den. Aug. 18, 1997).

Inclusion in § 11.100, Where are

Courts of Indian Offenses established?,

does not defeat the inherent sovereignty

of a tribe to establish tribal courts and

exercise jurisdiction under tribal law.

Tillett v. Lujan, 931 F.2d 636, 640 (10th

Cir. 1991) (CFR courts ‘‘retain some

characteristics of an agency of the

federal government’’ but they ‘‘also

function as tribal courts’’); Combrink v.

Allen, 20 Indian L. Rep. 6029, 6030 (Ct.

Ind. App., Tonkawa, Mar. 5, 1993) (CFR

court is a ‘‘federally administered tribal

court’’); Ponca Tribal Election Board v.

Snake, 17 Indian L. Rep. 6085, 6088 (Ct.

Ind. App., Ponca, Nov. 10, 1988) (‘‘The

Courts of Indian Offenses act as tribal

courts since they are exercising the

sovereign authority of the tribe for

which the court sits.’’). Such exercise of

inherent sovereignty and the

establishment of tribal courts shall

comply with the requirements in 25

CFR 11.100(c).

Need for Correction

As published, the proposed rule and

the correction to the proposed rule

contain errors which may prove to be

misleading and are in need of

clarification.

Correction of Publication

Accordingly, the publication on July

5, 1996 (61 FR 35158), of the proposed

regulations, which were the subject of

FR Doc. 96–16039, and the publication

of February 26, 1997 (62 FR 8664),

corrections to the proposed regulations,

which were the subject of FR Doc. 97–

4686, are corrected as follows:

§ 11.100 [Corrected]

In the Federal Register published July

5, 1996 on page 35159, and corrected on

February 26, 1997 on 1997 on page

8665, in § 11.100, paragraph (a) is,

corrected to read as follows:

§ 11.100 Where are Courts of Indian

Offenses established?

(a) Unless indicated otherwise in this

part, the regulations in this part apply

to the Indian country (as defined in 18

U.S.C. 1151) occupied by the tribes

listed below:

(1) Red Lake Band of Chippewa

Indians (Minnesota).

(2) Te-Moak Band of Western

Shoshone Indians (Nevada).

(3) Yomba Shoshone Tribe (Nevada).

(4) Kootenai Tribe (Idaho).

(5) Shoalwater Bay Tribe

(Washington).

(6) Eastern Band of Cherokee Indians

(North Carolina).

(7) Ute Mountain Ute Tribe

(Colorado).

(8) Quechan Indian Tribe (Arizona)

(except resident members).

(9) Hoopa Valley Tribe, Yurok Tribe

and Coast Indian Community of

California (California jurisdiction

limited to special fishing regulations).

(10) Louisiana Area (includes

Coushatta and other tribes located in the

State of Louisiana which occupy Indian

country and which accept the

application of this part); Provided, that

this part shall not apply to any

Louisiana tribe other than the Coushatta

Tribe until notice of such application

has been published in the Federal

Register.

(11) For the following tribes located in

the former Oklahoma Territory

(Oklahoma):

(i) Absentee Shawnee Tribe of Indians

of Oklahoma.

(ii) Apache Tribe of Oklahoma.

(iii) Caddo Tribe of Oklahoma.

(iv) Cheyenne-Arapaho Tribe of

Oklahoma.

(v) Citizen Band of Potawatomi

Indians of Oklahoma.

(vi) Comanche Tribe of Oklahoma

(Except Comanche Children’s Court).

(vii) Delaware Tribe of Western

Oklahoma.

(viii) Fort Sill Apache Tribe of

Oklahoma.

(ix) Iowa Tribe of Oklahoma.

(x) Kaw Tribe of Oklahoma.

(xi) Kickapoo Tribe of Oklahoma.

(xii) Kiowa Tribe of Oklahoma.

(xiii) Otoe-Missouria Tribe of

Oklahoma.
61058 Federal Register / Vol. 62, No. 220 / Friday, November 14, 1997 / Proposed Rules

(xiv) Pawnee Tribe of Oklahoma.

(xv) Ponca Tribe of Oklahoma.

(xvi) Tonkawa Tribe of Oklahoma.

(xvii) Wichita and Affiliated Tribes of

Oklahoma.

(12) For the following tribes located in

the former Indian Territory (Oklahoma):

(i) Chickasaw Nation.

(ii) Choctaw Nation.

(iii) Thlopthlocco Tribal Town.

(iv) Seminole Nation.

(v) Eastern Shawnee Tribe.

(vi) Miami Tribe.

(vii) Modoc Tribe.

(viii) Ottawa Tribe.

(ix) Peoria Tribe.

(x) Quapaw Tribe.

(xi) Wyandotte Tribe.

(xii) Seneca-Cayuga Tribe.

(xiii) Osage Tribe.

Dated: October 29, 1997.

Ada E. Deer,

Assistant Secretary—Indian Affairs.

[FR Doc. 97–29938 Filed 11–13–97; 8:45 am]

BILLING CODE 4310–02–P

DEPARTMENT OF DEFENSE

Office of the Secretary

32 CFR Part 199

RIN–0720–AA37

Civilian Health and Medical Program of

the Uniformed Services (CHAMPUS);

TRICARE Program; Reimbursement

AGENCY: Office of the Secretary, DoD.

ACTION: Proposed rule.

SUMMARY: This rule proposes to revise

certain requirements and procedures for

reimbursement under the TRICARE

program, the purpose of which is to

implement a comprehensive managed

health care delivery system composed of

military medical treatment facilities and

CHAMPUS. Issues addressed in this

proposed rule include: implementation

of changes made to the Medicare

Prospective Payment System (PPS) upon

which the CHAMPUS DRG-based

payment system is modeled and

required by law to follow wherever

practicable, along with changes to make

our DRG-based payment system operate

better; extension of the balance billing

limitations currently in place for

individual and professional providers to

non-institutional, non-professional

providers; adjusting the CHAMPUS

maximum allowable charge (CMAC) rate

in the small number of cases where the

CMAC rate is less than the Medicare

rate; and implementing the governmentwide debarment rule where any

provider excluded or suspended form

CHAMPUS shall be excluded from all

other programs and activities involving

Federal financial assistance, such as

Medicare or Medicaid, and adding

violations of our balance billing or

claims filing requirements to the list of

provider actions considered violations

of the TRICARE/CHAMPUS program.

DATES: Comments must be received on

or before January 13, 1998.

ADDRESSES: Tricare Support Office

(TSO), Program Development Branch,

Aurora, CO 80045–6900.

FOR FURTHER INFORMATION CONTACT:

Kathleen Larkin, Office of the Assistant

Secretary of Defense (Health Affairs),

telephone (703) 695–3350.

Questions regarding payment of

specific claims under the CHAMPUS

allowable charge method should be

addressed to the appropriate TRICARE/

CHAMPUS contractor.

SUPPLEMENTARY INFORMATION:

I. Proposed Changes Regarding The

Champus DRG-Based Payment System

The final rule published on

September 1, 1987, (52 FR 32992) set

forth the basic procedures used under

the CHAMPUS DRG-based payment

system. This was subsequently amended

by final rules published on August 31,

1988 (53 FR 33461), October 21, 1988

(53 FR 41331), December 16, 1988 (53

FR 50515), May 30, 1990 (55 FR 21863),

and October 22, 1990 (55 FR 42560).

This rule proposes to amend 32 CFR 199

to conform to changes made to the

Medicare Prospective Payment System

(PPS) upon which the CHAMPUS DRGbased payment system is modeled and

required by law to follow whenever

practicable. In addition, the rule

proposes to: eliminate the requirement

for the physician attestation form and

change the requirement for physician

acknowledgment statements; clarify

authorized payment reductions by

managed care support contractors for

noncompliance with required

utilization review procedures and; limit

the ambulatory surgery group payment

rate to the amount that would be

allowed if the services were provided on

an inpatient basis.

A. Heart and Liver Transplants

When we first implemented the

CHAMPUS DRG-based payment system

in 1987, we exempted all services

related to heart and liver

transplantation. Although both of these

types of transplants are subject to the

Medicare PPS, we initially exempted

them because at that time we had

limited experience and claims data for

them. We believed these limitations

could significantly skew the relative

weights we would calculate for such

transplants.

Since 1987 we have continued to

collect data on these services. From the

beginning, heart transplants were

grouped to DRG 103 and exempted. For

Fiscal Year 1991 the Health Care

Financing Administration (HCFA)

created DRG 480 for liver transplants,

but we continued to exempt them.

In our notice of updated rates and

weights for Fiscal Year 1991, which was

published on November 5, 1990 (55 FR

46545), we noted that we intended to

consider including both heart and liver

transplants in our DRG system in the

future, and we invited any comments in

that regard. We received none.

Since we have enough claims data to

calculate accurate weights for these

transplants, we are proposing to end the

DRG exemption for all CHAMPUS

covered solid organ transplants for

which there is an assigned DRG and

enough data to calculate the DRG

weight. Just as Medicare does, we will

continue to exempt acquisition costs for

all CHAMPUS covered solid organ

transplants.

B. Payment Requests for Capital and

Direct Medical Education Costs

Initially we required that hospitals

submit their request for payment of

capital and direct medical education

costs within three months of the end of

the hospital’s Medicare cost-reporting

period. However, some hospitals

encountered difficulties in meeting this

deadline, because HCFA implemented

changes which resulted in extensions to

the filing deadline. Therefore, we often

did not enforce our deadline, and as of

October 1988 we eliminated the

requirement entirely.

We eliminated the requirement

because we believed hospitals would

submit their requests at the earliest

possible time anyway. Also, we believed

there would be no adverse impact on

TRICARE/CHAMPUS. Neither of these

has proven to be correct. We continually

receive these requests well after the end

of the Medicare cost-reporting period—

in some cases several years later. As a

result, it is necessary for our contractors

to retain claims data in their systems

indefinitely, so that they can verify the

reported amounts when the requests are

submitted. This is proving to be a very

burdensome and costly requirement for

our contractors.

On June 27, 1995, HCFA published a

final rule (60 FR 33137) extending the

time frame providers have to file cost

reports from no later than 3 months after

the close of the period covered by the

report to no later than 5 months after the

close of that period. The rule also