Federal Register / Vol. 60, No. 52 / Friday, March 17, 1995 / Proposed Rules 14403

Office by contacting the person listed

under FOR FURTHER INFORMATION

CONTACT. All such meetings shall be

open to the public and, if possible,

notices of the meetings will be posted at

the locations listed under ADDRESSES. A

written summary of each public meeting

will be made a part of the

Administrative Record.

IV. Procedural Determinations

Executive Order 12866

This rule is exempted from review by

the Office of Management and Budget

(OMB) under Executive Order 12866

(Regulatory Planning and Review).

Executive Order 12778

The Department of the Interior has

conducted the reviews required by

section 2 of Executive Order 12778

(Civil Justice Reform) and has

determined that, to the extent allowed

by law, this rule meets the applicable

standards of subsections (a) and (b) of

that section. However, these standards

are not applicable to the actual language

of State regulatory programs and

program amendments since each such

program is drafted and promulgated by

a specific State, not by OSM. Under

sections 503 and 505 of SMCRA (30

U.S.C. 1253 and 1255) and 30 CFR

730.11, 732.15 and 732.17(h)(10),

decisions on proposed State regulatory

programs and program amendments

submitted by the States must be based

solely on a determination of whether the

submittal is consistent with SMCRA and

its implementing Federal regulations

and whether the other requirements of

30 CFR Parts 730, 731, and 732 have

been met.

National Environmental Policy Act

No environmental impact statement is

required for this rule since section

702(d) of SMCRA [30 U.S.C. 1292(d)]

provides that agency decisions on

proposed State regulatory program

provisions do not constitute major

Federal actions within the meaning of

section 102(2)(C) of the National

Environmental Policy Act (42 U.S.C.

4332(2)(C)).

Paperwork Reduction Act

This rule does not contain

information collection requirements that

require approval by OMB under the

Paperwork Reduction Act (44 U.S.C.

3507 et seq.).

Regulatory Flexibility Act

The Department of the Interior has

determined that this rule will not have

a significant economic impact on a

substantial number of small entities

under the Regulatory Flexibility Act (5

U.S.C. 601 et seq.). The State submittal

which is the subject of this rule is based

upon corresponding Federal regulations

for which an economic analysis was

prepared and certification made that

such regulations would not have a

significant economic effect upon a

substantial number of small entities.

Accordingly, this rule will ensure that

existing requirements previously

promulgated by OSM will be

implemented by the State. In making the

determination as to whether this rule

would have a significant economic

impact, the Department relied upon the

data and assumptions for the

corresponding Federal regulations.

List of Subjects in 30 CFR Part 935

Intergovernment relations, Surface

mining, Underground mining.

Dated: March 10, 1995.

Richard J. Seibel,

Acting Assistant Director, Eastern Support

Center.

[FR Doc. 95–6591 Filed 3–16–95; 8:45 am]

BILLING CODE 4310–05–M

DEPARTMENT OF DEFENSE

Office of the Secretary

32 CFR Part 199

RIN 0720–AA28

[DOD 6010.8–R]

Civilian Health and Medical Program of

the Uniformed Services (CHAMPUS);

Transplants

AGENCY: Office of the Secretary, DoD.

ACTION: Proposed rule.

SUMMARY: This rule proposes to

establish coverage for heart-lung, single

or double lung, and combined liverkidney transplantation for those patients

who meet specific patient selection

criteria; establish preauthorization

requirements for heart, liver, heart-lung,

single or double lung, combined liverkidney transplantation, high dose

chemotherapy and stem cell

transplantation, and air ambulance (in

conjunction with lung or heart-lung

transplantation preauthorizations);

extend coverage of cardiac rehabilitation

to those patients who have had heart

valve surgery, heart or heart-lung

transplantation, authorize an exception

to the ambulance benefit to allow organ

transplantation candidates to be

transported to a certified CHAMPUS

organ transplant center instead of the

closest appropriate facility, and

authorize pulmonary rehabilitation for

beneficiaries whose conditions are

considered appropriate for pulmonary

rehabilitation according to guidelines

adopted by the Director, OCHAMPUS,

or a designee, recognize certain

transplant centers that meet specific

criteria as an authorized CHAMPUS

institutional provider, and clarify the

CHAMPUS position on consortium

programs for organ transplantation to

allow individual hospitals which are

members of a consortium to use the

combined (pooled) experience and

survival data of the consortium team to

meet CHAMPUS requirements for

authorization as a certified CHAMPUS

organ transplant center.

DATES: Comments must be received on

or before May 16, 1995.

ADDRESSES: All comments concerning

this proposed rule should be addressed

to the Office of the Civilian Health and

Medical Program of the Uniformed

Services (OCHAMPUS), Program

Development Branch, Aurora, CO

80045–6900.

FOR FURTHER INFORMATION CONTACT:

Marty Maxey, OCHAMPUS, Program

Development Branch, telephone (303)

361–1227.

SUPPLEMENTARY INFORMATION:

OCHAMPUS has been actively

following the development of organ

transplantation for the past 10 years to

define an established method of

treatment for patients who have

exhausted more conservative medical

and surgical treatments. Following is an

overview of the events which have led

to the decision to allow CHAMPUS

coverage for heart-lung, single or double

lung, and combined liver-kidney

transplantation:

• In November 1990, OCHAMPUS

requested the Agency for Health Care

Policy and Research (AHCPR) to

conduct a technology assessment on the

safety and efficacy of heart-lung and

single or double lung transplantation. In

response to our request, AHCPR

informed OCHAMPUS that an

assessment was already in progress as a

result of a request by the Health Care

Financing Administration (HCFA).

Because of an increase in demand for

heart-lung and single or double lung

transplantation by the CHAMPUS

beneficiary population, OCHAMPUS

urged AHCPR to provide preliminary

interim guidelines for heart-lung and

single or double lung transplantation

which could be used until finalization

of their formal technology assessment.

In response to this request, AHCPR

asked the National Heart Lung and

Blood Institute (NHLBI) to assist in the

development of interim guidelines. On

February 28, 1991, NHLBI completed

the AHCPR request for preliminary
14404 Federal Register / Vol. 60, No. 52 / Friday, March 17, 1995 / Proposed Rules

interim guidelines on heart-lung and

single or double lung transplantation.

• In September 1992, CHAMPUS

requested the AHCPR to conduct a

technology assessment regarding the

safety and efficacy of combined liverkidney transplantation. The AHCPR

technology assessment was completed

on November 12, 1992. The findings of

the AHCPR assessment indicated that

combined liver-kidney transplantation

is an effective intervention in improving

survival in patients with end-stage renal

and hepatic disease.

• By August 1993, AHCPR finalized

the formal technology assessment on

both heart-lung and single or double

lung transplantation for HCFA and

forwarded a copy to OCHAMPUS. The

AHCPR assessments indicated that

heart-lung and single or double lung

transplantations were safe and effective

treatment for patients meeting specific

clinical criteria when performed by

institutions having demonstrated certain

levels of experience and success. The

patient selection and institutional

criteria recommended by the AHCPR

technology assessments were very

similar to the interim guidelines

developed by NHLBI in February 1991.

Due to the Presidential moratorium on

publication of regulations, OCHAMPUS

decided to proceed without rulemaking

and to implement the recommendations

of the interim guidelines for heart-lung

and single or double lung

transplantations from NHLBI and the

final recommendations from AHCPR for

combined liver-kidney transplantation

to meet the increasing needs of the

CAMPUS beneficiary population for

coverage of these procedures.

OCHAMPUS established effective dates

of coverage based on NHLBI and

AHCPR reports. OCHAMPUS adopted

the following beginning dates of

coverage for:

• Combined liver-kidney

transplantation on November 12, 1992.

• Heart-lung and single or double

lung transplantations on February 28,

1991. However, CHAMPUS would

consider retroactive coverage for any

heart-lung; single or double lung

transplantation performed at a facility

which met the interim criteria

established by NHLBI for both patient

selection and facility certification

criteria.

OCHAMPUS is publishing this

proposed rule to formally notify the

public of the specific CHAMPUS

requirements for coverage of benefits for

heart-long, single or double lung and

combined liver-kidney transplantations

to include related services and supplies

such as air ambulance in certain

circumstances when determined to be

medically necessary.

This proposed rule also authorizes

cardiac rehabilitation following heart

valve surgery, heart and heart-lung

transplantation, and pulmonary

rehabilitation for beneficiaries who

conditions are considered appropriate

according to guidelines that will be

implemented by the Director,

OCHAMPUS, or a designee.

In addition, this proposed rule

outlines the specific requirements for

providers who wish to be certified as a

CHAMPUS approved organ transplant

center including requirements for

consortia programs. CHAMPUS

recognizes that many facilities

performing organ transplantations

(particularly pediatric hospitals) are not

able to meet CHAMPUS standards for

certification as an authorized transplant

center. However, CHAMPUS will allow

facilities not able to meet the standards

to qualify as a CHAMPUS authorized

transplant center when they belong to a

consortium program whose combined

experience and survival data meet the

CHAMPUS criteria for qualifying as a

certified CHAMPUS organ transplant

center.

The specified definitions and

procedures outlined in the rule for

facilities to use in calculating survival

rates for transplantation use a simpler

format but are indential to those

published by HCFA (52 FR 10947, April

6, 1987).

At this time, OCHAMPUS, wishing to

protect beneficiaries from incurring outof-pocket expenses as a result of

noncovered care related to organ

transplantation and to ensure the

prudent expenditure of public funds, is

proposing to require transplantation

preauthorization for high dose

chemotherapy and stem cell

transplantation, all initial and

retransplanted organs, except kidney

and cornea, and preauthorization for air

ambulance for heart-lung and single or

double lung transplantation. The

preauthorization requirement will

protect both the beneficiary and the

provider.

Regulatory Procedures

OMB has determined that this is not

a significant rule as defined by

Executive Order 12866.

The Regulatory Flexibility Act (RFA)

requires that each federal agency

prepare, and make available for public

comment, a regulatory flexibility

analysis when the agency issues

regulations which would have a

significant impact on a substantial

number of small entities.

This proposed rule will not involve

any significant burden on OCHAMPUS

beneficiaries or providers. Based on

national statistics for heart-lung, single

or double lung and combined liverkidney transplantation, it is estimated

that .005% or less of the 6 million

CHAMPUS user population, will require

a heart-lung, single or double lung, or a

combined liver-kidney transplantation.

The proposed rule will broaden the

scope of CHAMPUS benefits while

protecting the beneficiaries and

providers from incurring additional

costs.

This rule represents an expansion of

benefits under the CHAMPUS program,

resulting in facility certification of

transplant centers and narrative

summaries for evaluation and

assessment for preauthorization of

transplantations. These transplant

centers are accustomed to the proposed

reporting requirements and would not

review this as an administrative

intrusion. Based on the above rationale,

it is felt that proposed reporting

requirements would not need to be

reviewed by the Executive Office of

Management and Budget under

authority of the Paperwork Reduction

Act of 1980 (44 U.S.C. 3501–3511).

List of Subjects in 32 CFR Part 199

Claims, Handicapped, Health

insurance, Military personnel.

Accordingly, 32 CFR part 199 is

proposed to be amended as follows:

PART 199—[AMENDED]

1. The authority citation for part 199

is proposed to be revised to read as

follows:

Authority: 5 U.S.C. 301; 10 U.S.C. chapter

55.

2. Section 199.4 is proposed to be

amended by revising paragraphs

(d)(3)(v)(B), (d)(3)(v)(D), and (e)(5) and

by adding paragraphs (d)(3)(v)(E),

(e)(18)(i)(F), (e)(18)(i)(G), and (e)(20) to

read as follows:

§ 199.4 Basic program benefits.

* * * * *

(d) * * *

(3) * * *

(v) * * *

(B) Ambulance service cannot be used

instead of taxi service and is not payable

when the patient’s condition would

have permitted use of regular private

transportation; nor is it payable when

transport or transfer of a patient is

primarily for the purpose of having the

patient nearer to home, family, friends,

or personal physician. Except as

described in paragraph (d)(3)(v)(A) and

(d)(3)(v)(E) of this section transport
Federal Register / Vol. 60, No. 52 / Friday, March 17, 1995 / Proposed Rules 14405

must be to the closest appropriate

facility by the least costly means.

* * * * *

(D) Except as described in paragraph

(d)(3)(v)(E) of this section ambulance

service by other than land vehicles

(such as a boat or airplane) may be

considered only when the pickup point

is inaccessible by a land vehicle, or

when great distance or other obstacles

are involved in transporting the patient

to the nearest hospital with appropriate

facilities and the patient’s medical

condition warrants speedy admission or

is such that transfer by other means is

contraindicated.

(E) (i) Advanced life support air

ambulance and certified advanced life

support attendant are covered services

for heart-lung; single or double lung

transplantation candidates and may be

preauthorized in conjunction with the

preauthorization for the transplantation.

Air ambulance transport for organ

transplantation candidates other than

heart-lung; single or double lung

transplantation may be covered if

determined to be medically necessary.

(ii) Advanced life support air

ambulance and certified advanced life

support attendant shall be reimbursed

subject to standard reimbursement

methodologies.

* * * * *

(e) * * *

(5) Organ transplanation—(i) General.

(A) CHAMPUS may cost-share

medically necessary services and

supplies related to organ transplants for:

(1) Evaluation of a potential

candidate’s suitability for organ

transplant, whether or not the patient is

ultimately accepted as a candidate for

transplant.

(2) Pre- and post-transplant inpatient

hospital and outpatient services.

(3) Pre- and post-operative services of

the transplant team.

(4) Blood and blood products.

(5) FDA approved

immunosuppression drugs to include

off-label uses when determined to be

medically necessary and generally

accepted practice within the general

medical community, (i.e., noninvestigational).

(6) Complications of the transplant

procedure, including inpatient care,

management of infection and rejection

episodes.

(7) Periodic evaluation and

assessment of the successfully

transplanted patient.

(8) The donor acquisition team,

including the costs of transportation to

the location of the donor organ and

transportation of the team and the

donated organ to the location of the

transplant center.

(9) The maintenance of the viability of

the donor organ after all existing legal

requirements for excision of the donor

organ have been met.

(B) CHAMPUS benefits are payable

for recipient costs when the recipient of

the transplant is a beneficiary, whether

or not the donor is a beneficiary.

(C) Donor costs are payable when:

(1) Both the donor and recipient are

CHAMPUS beneficiaries.

(2) The donor is a CHAMPUS

beneficiary but the recipient is not.

(3) The donor is the sponsor and the

recipient is a beneficiary. (In such an

event, donor costs are paid as a part of

the beneficiary and recipient costs.)

(4) The donor is neither a CHAMPUS

beneficiary nor a sponsor, if the

recipient is a CHAMPUS beneficiary.

(Again, in such an event, donor costs are

paid as a part of the beneficiary and

recipient costs.)

(D) If the donor is not a beneficiary,

CHAMPUS benefits for donor costs are

limited to those directly related to the

transplant procedure itself and do not

include any medical care costs related

to other treatment of the donor,

including complications.

(E) CHAMPUS benefits will not be

allowed for:

(1) Expenses waived by the transplant

center.

(2) Services and supplies not

provided in accordance with applicable

program criteria.

(3) Administration of an experimental

or investigational immunosuppressant

drug that is not FDA approved.

(4) Pre- or post-transplant nonmedical

expenses.

(5) Transportation of an organ donor.

(ii) Preauthorization requirements.

The Director, OCHAMPUS, or a

designee, is the preauthorizing authority

for stem cell transplantation and all

initial and retransplanted solid organs,

except kidney and corneal.

Preauthorization approval for stem cell,

solid organ transplantations, and

transportation by air ambulance (for

lung or heart-lung transplantation

patients) shall remain in effect as long

as the beneficiary continues to meet the

specific transplant criteria set forth

herein, or until the approved transplant

occurs.

(iii) Kidney transplantation. (A) With

specific reference to acquisition costs

for kidneys, each hospital that performs

kidney transplantations is required for

Medicare purposes to develop for each

year separate standard acquisition costs

for kidneys obtained from live donors

and kidneys obtained from cadavers.

The standard acquisition costs for

cadaver kidneys is compiled by dividing

the total cost of cadaver kidneys

acquired by the number of

transplantations using cadaver kidneys.

The standard acquisition cost for

kidneys from live donors is compiled

similarly using the total acquisition cost

of kidneys from live donors and the

number of transplantations using

kidneys from live donors. All recipients

of cadaver kidneys are charged the same

standard cadaver kidney acquisition

cost and all recipients of kidneys from

live donors are charged the same

standard live donor acquisition cost.

The appropriate hospital standard

kidney acquisition costs (live donor or

cadaver) required for Medicare in every

instance must be used as the acquisition

cost for purposes of providing

CHAMPUS benefits.

(B) In most instances for costs related

to kidney transplantation, Medicare (not

CHAMPUS) benefits will be applicable.

If a CHAMPUS beneficiary participates

as a kidney donor for a Medicare

beneficiary, Medicare will pay for

expenses in connection with the kidney

transplantation to include all reasonable

preparatory, operation and

postoperation recovery expenses

associated with the donation

(postoperative recovery expenses are

limited to the actual period of recovery).

(Refer to § 199.3(e)(3)(vi), ‘‘Eligibility.’’)

(iv) Liver transplantation.—(A)

Patient selection criteria. On July 1,

1983, CHAMPUS benefits are payable

for liver transplantation for beneficiaries

who:

(1) Are suffering from an irreversible

liver process; and,

(2) Have exhausted more conservative

medical and surgical treatments; and,

(3) Are approaching the terminal

phase of their illness (e.g., death is

imminent, irreversible damage to the

central nervous system is inevitable, or

the quality of life has deteriorated to

unacceptable levels), and

(4) Are considered appropriate for

liver transplantation according to

guidelines adopted by the Director,

OCHAMPUS.

(B) Contraindications. CHAMPUS

shall not provide coverage for liver

transplantation when any of the

following contraindications exist;

(1) Significant systemic or

multisystemic disease (other than

hepatic failure) which limits the

possibility of full recovery and may

compromise the function of the newly

transplanted organ.

(2) Active alcohol or other substance

abuse.

(3) Malignancies metastasized to or

extending beyond the margins of the

liver; or

(4) Life threatening or uncontrollable

abdominal or systemic sepsis.
14406 Federal Register / Vol. 60, No. 52 / Friday, March 17, 1995 / Proposed Rules

(v) Combined liver-kidney

transplantation—(A) Patient selection

criteria. On November 12, 1992,

CHAMPUS benefits are payable for

combined liver-kidney transplantation

for beneficiaries who:

(1) Are suffering from concomitant,

irreversible hepatic and renal failure;

and

(2) Have exhausted more conservative

medical and surgical treatments for

hepatic and renal failure; and

(3) Have plans for long-term

adherence to a disciplined medical

regimen that are feasible and realistic;

and

(4) Are considered appropriate for

combined liver-kidney transplantation

according to guidelines adopted by the

Director, OCHAMPUS.

(B) Contraindications. CHAMPUS

shall not provide coverage for combined

liver-kidney transplantation when any

of the following contraindications exist:

(1) Significant systemic or

multisystemic disease (other than

hepatorenal failure) which limits the

possibility of full recovery and may

compromise the function of the newly

transplanted organs.

(2) Active alcohol or other substance

abuse.

(3) Malignancies metastasized to or

extending beyond the margins of the

liver and/or kidney.

(4) Life threatening or uncontrollable

abdominal or systemic sepsis.

(vi) Heart transplantation: Patient

selection criteria. On November 7, 1986,

CHAMPUS benefits are payable for

heart transplantation for beneficiaries

who:

(A) Have an end-stage cardiac disease

which has not responded to or no longer

responds to other appropriate medical

and surgical therapies which might be

expected to yield both short- and longterm (3 to 5 year) survival comparable

to that of heart transplantation; and

(B) Have a very poor prognosis as a

result of poor cardiac functional status

(e.g., less than a 25 percent likelihood

of survival for six months); and

(C) Have plans for long-term

adherence to a disciplined medical

regimen that are feasible and realistic.

(D) Are considered appropriate for

heart transplantation according to

guidelines adopted by the director,

OCHAMPUS.

(vii) Heart-lung and lung

transplantation: Patient selection

criteria. On February 28, 1991,

CHAMPUS benefits are payable for

heart-lung and lung transplantation for

beneficiaries who:

(A) Have irreversible, progressively

disabling, end-stage pulmonary or

cardiopulmonary disease (for example,

less than a 50 percent likelihood of

survival for 8 months). Prognosis

otherwise must be good for both

survival and rehabilitation.

(B) Have tried or considered all other

medical and surgical therapies that

might have been expected to yield both

short- and long-term survival

comparable to that of transplantation.

(C) Have a realistic understanding of

the range of clinical outcomes that may

be encountered.

(D) Have plans for long-term

adherence to a disciplined medical

regimen that are feasible and realistic.

(E) Are considered appropriate for

heart-lung or lung transplantation

according to guidelines adopted by the

Director, OCHAMPUS.

(viii) High dose chemotherapy and

stem cell transplantation. CHAMPUS

benefits are payable for beneficiaries

whose conditions are considered

appropriate for high dose chemotherapy

and stem cell transplantation according

to guidelines adopted by the Director,

OCHAMPUS, or a designee.

* * * * *

(18) * * *

(i) * * *

(F) Heart valve surgery.

(G) Heart or Heart-lung

Transplantation.

* * * * *

(20) Pulmonary rehabilitation.

CHAMPUS benefits are payable for

beneficiaries whose conditions are

considered appropriate for pulmonary

rehabilitation according to guidelines

adopted by the Director, OCHAMPUS,

or a designee.

* * * * *

3. Section 199.6 is proposed to be

amended by revising paragraph

(b)(4)(ii), by removing paragraph

(b)(4)(iii); and redesignating paragraphs

(b)(4)(iv) through (b)(4)(xiv) as (b)(4)(iii)

through (b)(4)(xiii) to read as follows:

§ 199.6 Authorized providers.

* * * * *

(b) * * *

(4) * * *

(ii) Organ transplant centers—(A)

Certification requirements. To obtain

CHAMPUS approval as an organ

transplant center, the center must have:

(1) An active solid organ transplant

program.

(2) Participation in a donor organ

procurement program and network.

(3) An interdisciplinary team to

determine the suitability of candidates

for transplantation on an equitable

basis.

(4) An anesthesia team that is

available at all times.

(5) A nursing service team trained in

the hemodynamic support of the patient

and in managing immunosuppressed

patients.

(6) Pathology and immunology

resources that are available for studying

and reporting the pathological responses

to transplantation.

(7) Evidence that the center

safeguards the rights and privacy of

patients.

(8) Continual compliance with State

transplantation laws and regulations, if

any.

(9) Legal counsel familiar with

transplantation laws and regulations.

(B) Administrative requirement. A

CHAMPUS authorized organ transplant

center must provide a written statement

to the certifying authority agreeing to

the following administrative

requirements:

(1) Bill for all services and supplies

related to the organ transplantation

performed by its staff and bill for

services rendered by the donor hospital

after all existing legal requirements for

excision of the donor organ are met.

(2) Bill all donor services in the name

of the CHAMPUS patient.

(C) Reporting requirements. The

transplant center must report to the

certifying authority any decrease in

actuarial survival rates below the

actuarial survival rate established by

CHAMPUS for initial facility

certification.

(D) Liver transplant centers.

CHAMPUS shall provide coverage for

liver transplantation procedures

performed only by experienced

transplant surgeons at centers

complying with the provisions in

paragraph (b)(4)(ii)(A) of this section.

The transplant center must:

(1) Have board eligible or board

certified physicians and other experts in

the fields of hepatology, pediatrics,

infectious disease, nephrology with

dialysis capability, pulmonary medicine

with respiratory therapy support,

pathology, immunology, and

anesthesiology to complement a

qualified transplant team.

(2) Have a transplant surgeon that is

specifically trained for liver grafting

who can assemble and train a team to

function successfully whenever a donor

liver is available.

(3) Have at least a 70 percent one year

actuarial survival rate for 10 cases as

calculated using the Kaplan-Meier

product limit method. At least a 70

percent one year actuarial survival rate

for all subsequent liver transplants must

be maintained for continued CHAMPUS

approval.

(E) Heart transplant centers.

CHAMPUS shall provide coverage for

heart transplantation procedures

performed only by experienced
Federal Register / Vol. 60, No. 52 / Friday, March 17, 1995 / Proposed Rules 14407

transplant procedures performed only

by experienced transplant surgeons at

centers complying with provisions in

paragraph (b)(4)(ii)(A) of this section.

The transplant center must:

(1) Have experts in the fields of

cardiology, cardiovascular surgery,

anesthesiology, immunology, infectious

disease, nursing, social services, and

organ procurement to complement the

transplant team.

(2) Have an active cardiovascular

medical and surgical program as

evidenced by a minimum of 500 cardiac

catheterization and coronary

arteriograms and 250 open heart

procedures per year.

(3) Have an established heart

transplant program with documented

evidence of 12 or more heart transplants

in each of the three consecutive

preceding 12-month periods prior to the

date of application (a total of 36 or more

heart transplant procedures).

(4) Demonstrate actuarial survival

rates of 73 percent for one year and 65

percent for two years for patients who

have had heart transplants since January

1, 1982 at that facility. The KaplanMeier product limit method shall be

used to calculate actuarial survival.

(5) CHAMPUS approval will lapse if

either the number of heart transplants

falls below 8 in 12 months or if the oneyear actuarial survival rate falls below

60 percent for a consecutive 24-month

period.

(F) Lung transplant. This policy

applies only to those centers seeking

CHAMPUS certification for lung

transplantation only. Centers seeking

CHAMPUS certification as heart-lung

transplant centers must meet additional

requirements outlined in paragraph

(b)(4)(ii)(H) of this section.

(1) CHAMPUS shall provide coverage

for lung transplant procedures

performed only be experienced

transplant surgeons at centers

complying with the provisions outlined

in paragraph (b)(4)(ii)(A) of this section,

and meeting the following criteria:

(2) The center must have:

(i) Experts in the fields of cardiology,

cardiovascular surgery, pulmonary

disease, anesthesiology, immunology,

infectious disease, nursing, social

services, and organ procurement to

complement the transplant team.

(ii) Performed lung (single and/or

double) transplantation in at least 10

patients within the 12 months prior to

application and in at least an additional

10 patients prior thereto.

(iii) Demonstrated Kaplan-Meier

actuarial survival rates of no less than

65 percent at one-year post-transplant

for patients who have undergone a lung

transplantation at the center since

January 1, 1987.

(G) Heart-Lung and lung transplant.

CHAMPUS shall provide coverage for

heart-lung transplantation procedures

performed only by experienced

transplant surgeons at centers

complying with the provisions outlined

in paragraph (b)(4)(ii)(A) of this section,

and meeting the following criteria:

(1) The institutional and team

experience shall be based upon all lung

and heart-lung transplantations

performed since January 1, 1987, both

for transplant experience and actuarial

survival rates.

(2) To be accepted for lung

transplantation (single and/or double),

an institution and team must have:

(i) Performed lung and/or heart-lung

transplantation in at least 10 patients

within the 12 months prior to

application and in at least an additional

10 patients prior thereto, and

(ii) Achieved a documented KaplanMeier actuarial survival rate of no less

than 65 percent at one-year.

(iii) Fulfilled existing facility

certification criteria for heart

transplantation (either Medicare or

CHAMPUS); or fulfilled the CHAMPUS

facility certification criteria for facilities

applying only for lung transplantation

as outlined in paragraph (b)(4)(ii)(G) of

this section.

(3) To be accepted for heart-lung

transplantation, an institution and team

must fulfill the CHAMPUS facility

certification criteria for lung

transplantation and the existing facility

certification criteria (either Medicare of

CHAMPUS) for heart transplantation.

(H) Calculation of survival rates for

transplantation. Each facility seeking

CHAMPUS certification as a transplant

center must calculate survival rates

using the Kaplan-Meier (product-limit)

technique utilizing the definitions and

rules below. Each applicant facility

must identify its Kaplan-Meier actuarial

survival percentage at one year. Heart

transplant facilities must also identify

its Kaplan-Meier actuarial survival

percentage at two year point. Each

applicant facility must also submit

calculations to support the reported

actuarial survival percentage.

(1) Each applicant facility will report

all transplantation experience from its

inception at the facility, unless this

section otherwise prescribes a starting

date for the reporting of specific

transplantation experience.

(2) CHAMPUS recognizes the team

experience gained in retransplantation.

Therefore, retransplantation experience

must be reported and calculated in the

same manner as first transplantation

experience.

(3) All experience and survival rates

must be reported as of a point in time

that is no more than 90 days prior to the

submission of the application for

CHAMPUS certification. That date is

referred to as the fiducial date.

(4) Calculations assume survival only

to (and censoring on) the date of last

ascertained survival.

(5) Patients who are not thought to be

dead are considered ‘‘lost to follow-up’’

if they were:

(i) Operated more than 120 days

before the fiducial date, but have no

ascertained survival within 60 days of

the fiducial date; or

(ii) Operated from 61 to 120 days

before the fiducial date, but ascertained

survival is less than 60 days from date

of transplantation; or

(iii) Operated within 60 days of the

fiducial date, but not ascertained to

have survived as of the fiducial date.

(6) Survival must be calculated with

the assumption that each patient in the

‘‘lost to follow-up’’ category died on or

one day after the date of last ascertained

survival.

(7) Clearly defined and well justified

secondary or alternate treatment of ‘‘lost

to follow-up’’ may also be submitted,

but primary attention will be given to

the results using definitions and

procedures specified above.

(8) Facilities seeking certification for

lung and/or heart-lung transplantation

must report all lung and heart-lung

transplantation experience beginning

January 1, 1987. When facility

experience is reported and the actuarial

survival is calculated, lung and heartlung transplantation experience must be

combined to arrive at a single one year

survival percentage.

(I) Combined liver-kidney transplants.

If the facility is authorized as a

CHAMPUS (or Medicare) approved liver

transplant center as outlined in

paragraphs (b)(4)(ii)(B) and (b)(4)(ii)(E)

of this section, the facility may be

considered to be a CHAMPUS approved

center to perform combined liver-kidney

transplantations.

(J) Organ transplant consortia.

CHAMPUS shall approve individual

organ transplant centers which meet the

above provisions in paragraph

(b)(4)(ii)(B) of this section, and would

otherwise qualify as a CHAMPUSauthorized transplant center by:

(1) Using the combined experience

and actuarial survival data of a

consortium of which a single transplant

team rotates among member hospitals

for purposes of meeting the certification

requirements outlined in paragraphs

(b)(4)(ii)(E), (b)(4)(ii)(F), (b)(4)(ii)(G),

(b)(4)(ii)(H), and (b)(4)(ii)(I) of this
14408 Federal Register / Vol. 60, No. 52 / Friday, March 17, 1995 / Proposed Rules

section, for liver, heart, lung, heart-lung

and combined liver-kidney when,

(i) The hospitals are under common

control or have a formal affiliation

arrangement with each other under the

auspices of an organization such as a

university or a legally-constituted

medical research institute;

(ii) The hospitals share resources by

using the same personnel or services in

their transplant programs. The

individual physician members of the

transplant team practice in all of the

hospitals;

(iii) The same organ procurement

organization, immunology, and tissue

typing services are used by all the

hospitals; and

(iv) The hospital submits its

individual and combined experience

and survival data to the CHAMPUS

authorizing authority, and

(v) If one of the hospitals is a pediatric

transplant program, in addition to the

requirements previously listed the

following apply;

(A) Although pediatric surgeons and

pathologists are not required to practice

in the adult hospital and vice versa, it

can be documented that they otherwise

function as members of the transplant

team.

(B) The facility must have other solid

organ transplant program(s) that meet

CHAMPUS criteria for certification

based on actuarial survival rates and

experience.

(C) The surgeon responsible for the

transplant is commonly involved in the

type of surgery (i.e., related to

hepatology, cardiology and pulmonary

medicine) with children of the age and

size in whom the transplant is being

performed, and

(D) If the program involves heart

transplant, the facility must have an

active pediatric cardiovascular medical

and surgical program with a minimum

of 150 cardiac catheterizations

performed per year on patients in the

pediatric range. A surgical case load of

200 operations per year should be

performed in combined adult and

pediatric programs: Of these, at least

100 operation per year (three of four

should use extracorporeal circulation)

should be on pediatric patients. In

programs serving only a pediatric

population, at least 100 cardiac surgical

procedures (three of four should use

extracorporeal circulation) should be

performed per year.

* * * * *

4. Section 199.7 is proposed to be

amended by revising paragraph (f)(1)(ii)

to read as follows:

§ 199.7 Claims submission, review, and

payment.

* * * * *

(f) * * *

(1) * * *

(ii) Time limit on preauthorization.

Approved preauthorizations are valid

for specific periods of time, appropriate

for the circumstances presented and

specified at the time the

preauthorization is approved. In

general, preauthorizations are valid for

30 days. If the preauthorized service or

supplies are not obtained or commenced

within the specified time limit, a new

preauthorization is required before

benefits may be extended. Special rules

apply for organ, stem cell

transplantation, and air ambulance (in

conjunction with lung or heart-lung

transplantation preauthorizations) (refer

to § 199.4(e)(5)(ii)).

* * * * *

5. Section 199.15 is proposed to be

amended by revising paragraph

(b)(4)(ii)(C) to read as follows:

§ 199.15 Quality and utilization review peer

review organization program.

* * * * *

(b) * * *

(4) * * *

(ii) * * *

(C) An approved preauthorization

shall state the number of days,

appropriate for the type of care

involved, for which it is valid. In

general, preauthorizations will be valid

for 30 days. If the services or supplies

are not obtained within the number of

days specified, a new preauthorization

request is required. Special rules apply

for organ, stem cell transplantation, and

air ambulance (in conjunction with lung

or heart-lung transplantation

preauthorizations (refer to

§ 199.4(e)(5)(ii)).

* * * * *

Dated: March 13, 1995.

L.M. Bynum,

Alternate OSD Federal Register Liaison

Officer, Department of Defense.

[FR Doc. 95–6561 Filed 3–16–95; 8:45 am]

BILLING CODE 5000–04–M

DEPARTMENT OF THE INTERIOR

Fish and Wildlife Service

50 CFR Part 18

RIN 1018–AD21

Marine Mammals; Incidental Take

During Specified Activities

AGENCY: Fish and Wildlife Service,

Interior.

ACTION: Proposed rule.

SUMMARY: The Fish and Wildlife Service

(Service) hereby proposes to extend for

an additional 42 months through

December 15, 1998, the effectiveness of

the final regulations that authorize and

govern the incidental, unintentional

take of small numbers of polar bear and

walrus during year-round oil and gas

industry operations (exploration,

development, and production) in the

Beaufort Sea and adjacent northern

coast of Alaska.

DATES: Comments on this proposed rule

must be received by May 16, 1995.

ADDRESSES: Written comments should

be submitted by mail to Supervisor,

Office of Marine Mammals

Management, Fish and Wildlife Service,

1011 E. Tudor Road, Anchorage, AK

99503. Comments may also be hand

delivered to the same address during

normal working hours of 8 a.m. to 4:30

p.m., Monday through Friday, or sent by

FAX to 907/786–3816. Comments and

materials received in response to this

proposed action will be available for

public inspection at this address during

the normal working hours identified

above.

FOR FURTHER INFORMATION CONTACT:

Dave McGillivary, Supervisor, Office of

Marine Mammals Management, Fish

and Wildlife Service, 1011 E. Tudor

Road, Anchorage, AK 99503, 907/786–

3800, or Jeff Horwath, in the Service’s

Division of Fish and Wildlife

Management Assistance, Arlington,

Virginia, at 703/358–1718.

SUPPLEMENTARY INFORMATION: Under

provisions of section 101(a)(5)(A) of the

Marine Mammal Protection Act of 1972,

as amended (MMPA), the taking of

small numbers of marine mammals may

be allowed incidental to specified

activities other than commercial fishing

if the Director of the Service finds,

based on the best available scientific

evidence available, that the cumulative

total of such taking over a 5-year period

will have a negligible effect on these

species and will not have an

unmitigable adverse impact on the

availability of these species for

subsistence uses by Alaskan Natives. If

these findings are made, the Service is

required to establish specific regulations

for the activity that set forth:

Permissible methods of taking; means of

effecting the least practicable adverse

impact on the species and their habitat

and on the availability of the species for

subsistence uses; and requirements for

monitoring and reporting.

On December 17, 1991, BP

Exploration (Alaska), Inc., for itself and

on behalf of 14 other energy related

entities (hereafter collectively referred

to as ‘‘Industry’’) petitioned the Service