Federal Register / Vol. 60, No. 96 / Thursday, May 18, 1995 / Proposed Rules 26705

INFORMATION CONTACT. If no one requests

an opportunity to testify at the public

hearing, the hearing will not be held.

Filing of a written statement at the

time of the hearing is requested as it

will greatly assist the transcriber.

Submission of written statements in

advance of the hearing will allow OSM

officials to prepare adequate responses

and appropriate questions.

The public hearing will continue on

the specified date until all persons

scheduled to testify have been heard.

Persons in the audience who have not

been scheduled to testify, and who wish

to do so, will be heard following those

who have been scheduled. The hearing

will end after all persons scheduled to

testify and persons present in the

audience who wish to testify have been

heard.

3. Public Meeting

If only one person requests an

opportunity to testify at a hearing, a

public meeting, rather than a public

hearing, may be held. Persons wishing

to meet with OSM representatives to

discuss the proposed amendment may

request a meeting by contacting the

person listed under FOR FURTHER

INFORMATION CONTACT. All such meetings

will be open to the public and, if

possible, notices of meetings will be

posted at the locations listed under

ADDRESSES. A written summary of each

meeting will be made a part of the

administrative record.

IV. Procedural Determinations

1. 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).

2. 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 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 AMLR plans

and revisions thereof since each such

plan is drafted and promulgated by a

specific State, not by OSM. Decisions on

proposed State AMLR plans and

revisions thereof submitted by a State

are based on a determination of whether

the submittal meets the requirements of

Title IV of SMCRA (30 U.S.C. 1231–

1243) and the applicable Federal

regulations at 30 CFR Parts 884 and 888.

3. National Environmental Policy Act

No environmental impact statement is

required for this title since agency

decisions on proposed State AMLR

plans and revisions thereof are

categorically excluded from compliance

with the National Environmental Policy

Act (42 U.S.C. 4332) by the Manual of

the Department of the Interior (516 DM

6, appendix 8, paragraph 8.4B(29)).

4. 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.).

5. 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 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

established by SMCRA or 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 in the analyses for

the corresponding Federal regulations.

List of Subjects in 30 CFR Part 950

Intergovernmental relations, Surface

mining, Underground mining.

Dated: May 12, 1995.

John Heider,

Acting Regional Director, Western Regional

Coordinating Center.

[FR Doc. 95–12264 Filed 5–17–95; 8:45 am]

BILLING CODE 4310–05–M

DEPARTMENT OF DEFENSE

Office of the Secretary

32 CFR Part 199

[DoD 6010.8–R]

RIN 0720–AA29

Civilian Health and Medical Program of

the Uniformed Services (CHAMPUS);

Clarification of the CHAMPUS

Definition of Experimental

AGENCY: Office of the Secretary, DoD.

ACTION: Proposed rule.

SUMMARY: This rule proposes to clarify

the CHAMPUS definition of

‘‘experimental’’ and describes the

process that the Office of CHAMPUS

follows in determining when an

experimental procedure has moved from

the status of experimental to the

position of nationally accepted medical

practice. This clarification is necessary

to ensure the CHAMPUS beneficiary

and provider population understand the

process the Office of CHAMPUS

(OCHAMPUS) follows prior to

endorsement by CHAMPUS of a new

emerging medical technology, drug, or

device for which the safety and efficacy

have been proven to be comparable or

superior to conventional therapies.

DATES: Written public comments must

be received on or before July 17, 1995.

ADDRESSES: Forward comments 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:

Ruth Smith, Program Development

Branch, OCHAMPUS, telephone (303)

361–1181.

SUPPLEMENTARY INFORMATION:

A. Discussion of CHAMPUS Policy

Under statutes governing CHAMPUS

including 10 U.S.C. 1079, CHAMPUS

payments are prohibited for health care

services that are ‘‘not medically or

psychologically necessary.’’ The

purpose of this provision, common in

health care payment programs, is to

prevent CHAMPUS beneficiaries from

being exposed to less than fully

developed and tested medical

procedures and to avoid the associated

risk of unnecessary unproven treatment.

CHAMPUS regulations and program

policies restrict benefits to those

procedures for which the safety and

efficacy have been proven to be

comparable or superior to conventional

therapies. In general, the CHAMPUS

regulations and program policies

exclude cost-sharing of procedures

which are experimental or

investigational. The evolution of any

medical technology or procedure from

experimental status to one of national

acceptance is often controversial, with

those members of the medical

community who are using and

promoting the procedure arguing that

the procedure has national acceptance.

In determining whether a procedure is

investigational, CHAMPUS uses the

following hierarchy of assessment

sources:
26706 Federal Register / Vol. 60, No. 96 / Thursday, May 18, 1995 / Proposed Rules

1. Outcome-based, Phase III trials

published in refereed medical literature.

2. Formal technology assessments

from nationally recognized technology

assessment groups, such as the:

—Agency for Health Care Policy and

Research (AHCPR); the

—Emergency Care Research Institute

(ECRI); and the

—Food and Drug Administration (FDA).

3. National medical policy

organization positions such as the:

—Medical Advisory Panel of the

National Blue Cross/Blue Shield

Association.

4. National professional medical

associations such as those promulgated

by the:

—American College of Obstetricians and

Gynecologists.

5. National expert opinion

organizations such as the

—Diagnostic and Therapeutic

Technology Assessment (DATTA)

group of the American Medical

Association;

—Health Care Financing Administration

Technical Advisory Committee; and

the

—Office of CHAMPUS Physician

Advisory Panel (representing the

Uniformed Services Surgeons

General). OCHAMPUS has chosen

Phase III clinical trials as the test for

measuring the safety and efficacy of

evolving medical technology

procedures. Clinical trials are

organized into three phases according

to the extent to which a therapy,

procedure, drug or device, has

progressed in testing. The phase

number affixed to a study does not

necessarily correspond to the disease

stage of patients enrolled in it. For

example, in:

Phase I clinical trials, the therapies,

procedures, drugs or devices used in

this stage of testing have been

extensively studied in laboratory and

animal tests and are usually now being

given to humans for the first time. The

aim is to find out how to give a drug or

use a procedure, and to make sure that

it does not have harmful side effects.

Because the side effects in humans are

unknown, only a relatively small

number of people are allowed to

participate.

Therapies, procedures, drugs or

devices, that successfully complete

Phase I trials then proceed to Phase II

clinical trials. Since the therapies,

procedures, drugs, or devices were

extensively studied in Phase I clinical

trials, side effects of each are generally

known and more people are included at

this phase. Many of the people involved

in Phase II clinical trials still have other

treatment options available to them if

the trial therapy, procedure, drug, or

device is not effective for them.

Next, the therapies, procedures, drugs

or devices used in Phase II clinical trials

move to Phase III clinical trials if each

is continuing to demonstrate safety and

effectiveness. In this phase the therapy,

procedure, drug or device being tested

is compared directly with the nationally

accepted standard therapy to determine

if one is superior to the other, or if one

is more effective for specific types or

stages of disease. Since reasonable

safety and effectiveness have been

shown through Phase I and Phase II,

many more patients are used in a Phase

III clinical trial. Additionally, the

patients participating in a Phase III

clinical trial usually have not undergone

standard treatment. The patients

participating in Phase III clinical trials

are started on either standard or

experimental therapy so the results can

be compared. Additionally, instead of

focusing on a single agent, some clinical

trials study a new drug used in

combination with one or more other

compounds or other treatments such as

surgery or radiation. These clinical trials

usually enroll large numbers of people,

and often they produce the most

dramatic results.

CHAMPUS policy and benefit

structure are never based solely on

coverage offered by other third party

payers, including Medicare, since each

operates under different rules and

requirements.

B. Need for the Regulation

This proposed rule does not present

new agency policy. Rather, it proposes

to reaffirm and clarify existing

CHAMPUS policy in the body of the

CHAMPUS regulation. We propose this

primarily in response to a series of U.S.

district court decisions concerning one

particular experimental treatment, high

dose chemotherapy (HDC) with stem

cell rescue (SCR) as a treatment for

breast cancer (discussed more below), in

which the courts held that the

CHAMPUS determination regarding this

treatment was not sufficiently

established to be accepted by the courts.

For example, in Hawkins v. Mail

Handlers Benefit Plan and CHAMPUS,

Civil No. 1:94CV6, W.D.N.C. (Jan. 28,

1994), the court ruled on a motion for

a preliminary injunction filed by a

beneficiary of both the Mail Handlers

Benefit Plan and CHAMPUS, seeking a

court order overruling the exclusion in

both plans of coverage for HDC/SCR as

a treatment for breast cancer. The court

ruled in favor of the Mail Handlers

Benefit Plan, but against CHAMPUS

based on judgment that the

determination that this procedure was

experimental was not clearly

established by CHAMPUS and was not

supported by the beneficiary’s evidence.

Similarly, in Wheeler v. Dynamic

Engineering Inc., and CHAMPUS, No.

4.94CV16, E.D.Va. (April 4, 1994),

another case of a beneficiary covered by

both an employer plan and CHAMPUS

who sought a judgment that both should

cover HDC/SCR for breast cancer

treatment, the court made a distinction

between a new company plan that

specifically excluded the procedure and

the former company plan and

CHAMPUS, both of which did not

expressly do so. After determining that

the former plan was applicable (based

on the date the treatment began), the

court ruled that neither the plan nor

CHAMPUS could properly exclude

coverage of the procedure.

OCHAMPUS has carefully reviewed

the evidence on HDC/SCR as a

treatment for breast cancer. It is our

conclusion that it is experimental

treatment because on Phase III trials

have proven the safety and efficacy of

HDC/SCR to be comparable or superior

to conventional therapies for breast

cancer (and certain other cancers as

well), and because formal technology

assessment studies have concluded

similarly. The CHAMPUS policy

regarding the investigational nature of

HDC/SCR for breast cancer is based

upon four primary sources:

1. The 1988 study entitled ‘‘Public

Health Service Reassessment:

Autologous Bone Marrow

Transplantation’’ prepared by the Office

of Health Technology Assessment,

Agency for Health Care Policy and

Research (OHTA/AHCPR) of the Public

Health Service, and authored by Harry

Handelsman, D.O.; and

2. The American Medical Association

Diagnostic and Therapeutic Technology

Assessment (AMA DATTA) evaluation

of January 1990 entitled ‘’Autologous

Bone Marrow Transplantation 0

Reassessment’’ by Elizabeth Brown,

M.D.; and

3. The June 1993 study entitled

‘‘Autologous Bone Marrow Transplant

and Peripheral Blood Stem Cell Rescue

for the Treatment of Breast Cancer’’

copyright by ECRI, 5200 Butler Pike,

Plymouth Meeting, PA 19462; and

4. The most recent ECRI assessment of

‘‘Autologous Bone Marrow Transplant

and Peripheral Blood Stem Cell Rescue

for the Treatment of Breast Cancer.’’

Summary information on this

assessment was published in Health

Technology Trends in June 1994.

OCHAMPUS received a copy of

essentially the same material in press
Federal Register / Vol. 60, No. 96 / Thursday, May 18, 1995 / Proposed Rules 26707

release form directly from ECRI on June

7, 1994. Based upon the information

contained in these press releases,

OCHAMPUS has requested the purchase

of the completed Health Technology

Assessment Report from ECRI, a draft

which has already been received.

Since the time the 1988 and 1990

reports mentioned above were initially

prepared, OCHAMPUS has performed a

continuous review of the refereed

medical literature on this topic, and has

had numerous confirming discussions

with the Office of Health Technology

Assessment (OHTA) of the Public

Health Service regarding their position.

The latest of these discussions

confirmed the lack of refereed medical

literature that would support

CHAMPUS coverage of this procedure

for the treatment of breast carcinoma.

Therefore, although the initial policy

classifying HDC/SCR as investigational

under CHAMPUS was based upon

literature and technical assessments

dating from the 1988–1990 time-frame,

OCHAMPUS has continually monitored

the development of the literature and

the status of ongoing Phase III trials

regarding the safety and effectiveness of

this form of treatment for breast

carcinoma and other carcinomas for

which it is not currently authorized as

a CHAMPUS benefit. The June 1993

formal assessment by ECRI provides

independent reconfirmation of the

CHAMPUS position. This independent

reconfirmation has been substantially

bolstered by the most recent ECRI

studies which indicate that ‘‘results

from the experimental procedure are not

any better than published results for

conventional therapy to treat breast

cancer,’’ and that ‘‘the impetus for this

(treatment) is more political than

scientific * * * (It) is a treatment that’s

becoming mandated by popular

opinion.’’ This most recent information

reconfirms, in even stronger terms and

with newer studies and literature, the

earlier conclusions of previous

technology assessments that HDC/SCR

is experimental in the treatment of

breast cancer. To date there has been no

new evidence which would warrant a

departure from the original coverage

determination to exclude CHAMPUS

cost-sharing of this procedure as

investigational for the treatment of

breast carcinoma. The CHAMPUS

position is further supported by the

Consensus Conference on Intensive

Chemotherapy Plus Hematopoietic Stem

Cell Transplantation in Malignacies

(Journal of Oncology, Volume 12,

Number 1, (January 1994); pages 226–

231; (Attachment 5) which states in

part:

* * * ‘‘Although there is currently

insufficient evidence to justify the use

of HDC/plus HSC (Hematopoietic Stem

Cell) transplantation outside the setting

of clinical trial for any stage of breast

cancer, there is ample scientific

background for vigorous clinical

investigation in this important area

* * *’’.

Based on the evidence regarding this

procedure, which demonstrates that it is

experimental, and the series of recent

court rulings declining to follow an

exclusion not clearly established in the

governing instruments of the program,

we believe this rule is necessary to

reaffirm and clarify CHAMPUS policy

on experimental procedures and to

specifically list a number of procedures

we have determined are experimental.

C. Provisions of the Proposed Rule

The proposed rule describes the

criteria we use to identify the

experimental nature of procedures,

drugs, devices, includes a partial list,

and makes provision for promptly

treating a drug, device or procedure as

no longer experimental when the

scientific evidence supports that view

and the resultant. Any change to the

partial list will be published as a notice

in the Federal Register.

In emphasizing refereed medical

literature as the primary source of

persuasive evidence that a particular

procedure’s safety and efficacy have

been proven to be comparable or

superior to conventional therapies for

widespread use, we also underscore our

support for committed efforts to

advance medical research. A number of

military medical centers are engaged in

such research protocols. In addition, we

are beginning a new DoD demonstration

project, under the authority of 10 U.S.C.

1092, to authorize payments for

experimental treatments provided to

CHAMPUS beneficiaries under certain

government approved phase III clinical

protocols. Initially, the demonstration

project will apply to clinical trials under

approved National Cancer Institute

protocols for high dose chemotherapy

with stem cell rescue for breast cancer

treatment.

D. Regulatory Procedures

Executive Order 12866 requires

certain regulatory assessments for any

‘‘significant regulatory action,’’ defined

as one which would result in an annual

effect on the economy of $100 million

or more, or have other substantial

impacts.

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

significant impact on a substantial

number of small entities.

This proposed rule is not a significant

regulatory action under Executive Order

12866. This proposed rule will not

involve any significant burden on the

CHAMPUS beneficiary or provider

population. This proposed rule only

clarifies the CHAMPUS definition of

experimental and describes the process

that OCHAMPUS follows in

determining for purposes of benefit

coverage when an experimental

procedure, drug, or device has moved

from the status of experimental to the

position of nationally accepted medical

practice. This proposed rule does not

impose information collection

requirements on the public under the

Paperwork Reduction Act of 1980 (44

U.S.C. 3501–3511).

This is a proposed rule. Comments

from all interested parties are solicited.

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:

1. The authority citation for Part 199

continues to read as follows:

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

55.

2. Section 199.2 is amended in

paragraph (b) by revising the definition

of ‘‘Experimental’’, removing the Note

following the definition of

‘‘Experimental’’ and adding the

definitions for ‘‘Rare diseases’’ and

‘‘Unlabelled or off labeled drugs’’ in

alphabetical order to read as follows:

§ 199.2 Definitions.

* * * * *

(b) * * *

Experimental. A drug, device, or

medical treatment or procedure is

experimental or investigational;

(1) If the drug or device cannot be

lawfully marketed without approval of

the Untied States Food and Drug

Administration (FDA) and approval for

marketing has not been given at the time

the drug or device is furnished to the

patient; or

(2) If reliable evidence shows that the

drug, device, or medical treatment or

procedure is the subject of ongoing

Phase I, II, or III clinical trials or is

under study to determine its maximum

tolerated dose, its toxicity, its safety, its

efficacy as compared with the standard

means of treatment or diagnosis; or

(3) If reliable evidence shows that the

consensus of opinion among experts

regarding the drug, device, or medical
26708 Federal Register / Vol. 60, No. 96 / Thursday, May 18, 1995 / Proposed Rules

treatment or procedure is that further

studies or clinical trials are necessary to

determine its maximum tolerated dose,

its toxicity, its safety, or its efficacy as

compared with the standard means of

treatment or diagnosis. (See Exclusions

and limitations, ‘‘Not in accordance

with accepted standards, experimental

or investigational’’ in § 199.4 for

procedures in determining

experimental.)

* * * * *

Rare diseases. CHAMPUS defines a

rare disease as one which affects fewer

than one in 200,000 Americans.

* * * * *

Unlabelled or off labeled drugs.

Medications that are otherwise Food

and Drug Administration (FDA)

approved for general use in humans.

The drug must be medically necessary

for the treatment of the condition for

which it is administered, according to

accepted standards of medical practice.

* * * * *

3. Section 199.4 is amended by

revising paragraph (g)(15) as follows:

§ 199.4 Basic program benefits.

* * * * *

(g) Exclusions and limitations. * * *

* * * * *

(15) Not in accordance with accepted

standards, experimental, or

investigational. Among the services

excluded from CHAMPUS program

benefits on the grounds that they are not

medically or psychologically necessary

are services and supplies not provided

in accordance with accepted

professional medical standards, or

related to essentially experimental or

investigational procedures or treatment

regimens. (See the definition of

‘‘experimental’’ in § 199.2.)

(i) General. For the purpose of

determining experimental:

(A) The term reliable evidence shall

mean only:

(1) Outcome-based, Phase III trials

published in refereed medical literature.

(2) Published formal technology

assessments.

(3) The published reports of national

professional medical associations.

(4) Published national medical policy

organization positions.

(5) The published reports of national

expert opinion organizations.

(B) The order given in the iteration of

sources of evidence in paragraph

(g)(15)(i)(A) of this section is in the

order of the relative weight to be given

to any particular source. Only those

reports and articles containing

scientifically validated data and

published in the refereed medical and

scientific literature shall be considered

as meeting the requirements of reliable

evidence. Specifically not included in

the meaning of reliable evidence are

reports, articles, or statements by

providers or groups of providers

containing only abstracts, anecdotal

evidence or personal professional

opinions. Also not included in the

meaning of reliable evidence is the fact

that a provider or a number of providers

have elected to adopt a drug, device, or

medical treatment or procedure as their

personal treatment or procedure of

choice or standard of practice.

(C)(1) Use of drugs and medicines and

devices not approved by the FDA for

commercial marketing, that is, for

general use by humans (even though

permitted for testing on human beings)

is considered experimental. Drugs

grandfathered by the Federal Food, Drug

and Cosmetic Act of 1938 may be

covered under CHAMPUS as if FDA

approved. Certain cancer drugs,

designated as Group C drugs (approved

and distributed by the National Cancer

Institute) and Treatment Investigational

New Drugs (INDs), cannot be costshared under CHAMPUS because they

are not approved for commercial

marketing by the FDA. However,

medical care related to the use of Group

C drugs and Treatment INDs can be

cost-shared under CHAMPUS when the

patient’s medical condition warrants

their administration and the care is

provided in accordance with generally

accepted standards of medical practice.

In areas outside the United States,

standards comparable to those of the

FDA are the CHAMPUS objective.

(2) CHAMPUS can consider costsharing ‘‘unlabelled or off label’’ uses of

medications that are otherwise

approved by the FDA for general use in

humans. Approval for cost-sharing of

‘‘off label or unlabelled’’ indications

requires review for medical necessity,

and also requires demonstrations from

medical literature, national

organizations, and/or technology

assessment bodies that the ‘‘off label or

unlabelled’’ usage of the drug is safe,

effective, and a nationally accepted

standard of practice in the medical

community.

(D) CHAMPUS benefits for a rare

disease are reviewed on a case-by-case

basis by the Director, OCHAMPUS, or

designee. In reviewing the case, the

Director, OCHAMPUS, or designee may

consult with any or all of the following

sources to determine if the proposed

therapy is considered safe and effective:

(1) Trials published in refereed

medical literature.

(2) Formal technology assessments.

(3) National medical policy

organization positions.

(4) National professional associations.

(5) Regional expert opinion

organizations.

(6) Individual and small group expert

opinion.

(ii) Care excluded. This exclusion

includes all services directly related to

the experimental or investigational

procedure. However, CHAMPUS may

cost-share services or supplies when

there is no logical or causal relationship

between the experimental or

investigational procedure and the

treatment at issue or where such a

logical or causal relationship cannot be

established with a sufficient degree of

certainty. This CHAMPUS cost-sharing

is authorized in the following

circumstances:

(A) Treatment that is not related to the

investigational or experimental

procedure; e.g., medically necessary in

the absence of the experimental or

investigational treatment.

(B) Treatment which is a necessary

follow-on to the experimental or

investigational procedure but which

might have been necessary in the

absence of the experimental or

investigational treatment.

(iii) Examples of experimental

procedures. This paragraph consists of a

partial list of experimental or

investigational procedures. Such

procedures are excluded from

CHAMPUS program benefits. This list is

not all inclusive. Other experimental

procedures, as defined in § 199.2, are

similarly excluded, although they do

not appear on this partial list. With

respect to any procedure included on

this partial list, if and when the

Director, OCHAMPUS determines that

based on the standards established in

the definition of ‘‘experimental’’ in

§ 199.2, such procedure is no longer

experimental or investigational, the

Director will initiate action to remove

the procedure from this partial list of

experimental procedures. From the date

established by the Director as the date

the procedure became no longer

experimental until the date the

regulatory change is made to remove the

procedures from the partial list of

experimental procedures, the Director,

OCHAMPUS will suspend treatment of

the procedure as an experimental

procedure. Following is the noninclusive, partial list of experimental

procedures, all of which are excluded

from CHAMPUS benefits:

(A) Radial keratotomy (refractive

keratoplasty).

(B) Cellular therapy.

(C) Histamine therapy.

(D) Stem cell assay, a laboratory

procedure which allows a determination

to be made of the type and dose of
Federal Register / Vol. 60, No. 96 / Thursday, May 18, 1995 / Proposed Rules 26709

cancer chemotherapy drugs to be used,

based on in vitro analysis of their effects

on cancer cells taken from an

individual.

(E) Topical application of oxygen.

(F) Immunotherapy for malignant

disease.

(G) Prolotherapy, joint sclerotherapy,

and ligamentous injections with

sclerosing agents.

(H) Transcervical block silicone plug.

(I) Whole body hyperthermia in the

treatment of cancer.

(J) Portable nocturnal hypoglycemia

detectors.

(K) Testosterone pellet implants in the

treatment of females.

(L) Estradiol pellet implants.

(M) Epikeratophakia for treatment of

aphakia and myopia.

(N) Bladder stimulators.

(O) Ligament replacement with

absorbable copolymer carbon fiber

scaffold.

(P) Intraoperative radiation therapy.

(Q) Gastric bubble or balloon.

(R) Single and dual photon

absorptiometry for the detection and

monitoring of osteoporosis.

(S) Dorsal root entry zone (DREZ)

thermocoagulation or microcoagulation

neurosurgical procedure.

(T) Brain electrical activity mapping

(BEAM).

(U) Topographic brain mapping

(TBM) procedure.

(V) Ambulatory blood pressure

monitoring.

(W) Bilateral carotid body resection to

relieve pulmonary symptoms.

(X) Intracavitary administration of

cisplatin for malignant disease.

(Y) Cervicography.

(Z) Ambulatory home monitoring—

uterine contractions.

(AA) Sperm evaluation, hamster

penetration test.

(BB) Transfer factor (TF).

(CC) Continuous ambulatory

esophageal pH monitoring (CAEpHM) is

considered investigational for patients

under age 12 for all indications, and for

patients over age 12 for sleep apnea.

(DD) Adrenal-to-brain transplantation

for Parkinson’s disease.

(EE) Videofluoroscopy evaluation in

speech pathology.

(FF) Herniography.

(GG) Applied kinesiology.

(HH) Hair analysis to identify mineral

deficiencies from the chemical

composition of the hair. Hair analysis

testing may be reimbursed when

necessary to determine lead poisoning.

(II) Iridology (links flaws in eye

coloration with diseases elsewhere in

the body).

(JJ) Small intestinal bypass

(jejunoileal bypass) for treatment of

morbid obesity.

(KK) Biliopancreatic bypass.

(LL) Gastric wrapping/gastric

banding.

(MM) Calcium EAP/calcium orotate

and selenium (also known as Nieper

therapy)—Involves inpatient care and

use of calcium compounds and other

non-FDA approved drugs and special

diets. Used for cancer, heart disease,

diabetes, and multiple sclerosis.

(NN) Percutaneous balloon

valvuloplasty for mitral and tricuspid

valve stenosis.

(OO) Amniocentesis performed for

ISO immunization to the ABO blood

antigens.

(PP) Balloon dilatation of the prostate.

(QQ) Helium in radiosurgery.

(RR) Palladium 103Pd) seed

brachytherapy.

(SS) Electrostimulation of salivary

production in the treatment of

xerostomia secondary to Sjorgren’s

syndrome.

(TT) Interaoperative monitoring of

sensory evoked potentials (SEP). To

include visually evoked potentials,

brainstem auditory evoked response,

somatosensory evoked potentials during

spinal and orthopedic surgery, and

sensory evoked potentials monitoring of

the sciatic nerve during total hip

replacement. Recording SEPs in

unconscious head injured patients to

assess the status of the somatosensory

system. The use of SEPs to define

conceptional or gestational age in

preterm infants.

(UU) Autolymphocyte therapy (ALT)

(immunotherapy used for treating

metastatic kidney cancer patients).

(VV) Radioimmunoguided surgery in

the detection of cancer.

(WW) HLA–DNA typing.

(XX) Gait analysis (also known as a

walk study or electrodynogram).

(YY) Cryosurgery for liver metastases.

(ZZ) Use of cerebellar stimulators/

pacemakers for the treatment of

neurologic disorders.

(AAA) Signal-averaged ECG.

(BBB) Intraventricular administration

of narcotics.

(CCC) Peri-urethral Teflon injections

to manage urinary incontinence.

(DDD) Extraoperative

electrocorticography for stimulation and

recording in order to determine

electrical thresholds of neurons as an

indicator of seizure focus.

(EEE) Quantitative computed

tomography (QCT) for the detection and

monitoring of osteoporosis.

(FFF) Percutaneous transluminal

angioplasty in the treatment of

obstructive lesions of the carotid,

vertebral and cerebral arteries.

(GGG) Endoscopic third

ventriculostomy.

(HHH) Holding therapy—Involves

holding the patient in an attempt to

achieve interpersonal contact, and to

improve the patient’s ability to

concentrate on learning tasks.

(III) In utero fetal surgery.

(JJJ) Light therapy for seasonal

depression (also known as seasonal

affective disorder (SAD)).

(KKK) Transurethral laser incision of

the prostrate (TULIP).

(LLL) Contigen Bard collagen

implant.

(MMM) Dorsal column and deep brain

electrical stimulation of treatment of

motor function disorder.

(NNN) Chelation therapy, except

under specific conditions.

(OOO) All organ transplants except

heart, heart-lung, lung, kidney, some

bone marrow, liver, liver-kidney,

corneal, and heart-valve.

(PPP) Implantable infusion pumps,

except for hepatic artery perfusion

chemotherapy for the treatment of

primary liver cancer or metastatic

colorectal liver cancer.

(QQQ) Services related to the

candidiasis hypersensitivity syndrome,

yeast syndrome, or gastrointestinal

candidiasis (i.e., allergenic extracts of

Candida albicans for immunotherapy

and/or provocation/neutralization).

(RRR) Treatment of chronic fatigue

syndrome.

(SSS) Extracorporeal

immunoadsorption using protein A

columns for conditions other than acute

idiopathic thrombocytopenia purpura.

(TTT) Dynamic posturography (both

static and computerized).

(UUU) Laparoscopic myomectomy.

(VVV) Growth factor, including

platelet-derived growth factors, for

treating non-healing wounds. This

includes procuremen, a plateletderived wound-healing formula.

(WWW) High dose chemotherapy

with stem cell rescue (HDC/SCR) for any

of the following malignancies:.

(1) Breast cancer.

(2) Ovarian cancer.

(3) Testicular cancer.

(4) Multiple myeloma.

* * * * *

Dated: May 11, 1995.

L.M. Bynum,

Alternate OSD Federal Register Liaison

Officer, Department of Defense.

[FR Doc. 95–12031 Filed 5–17–95; 8:45 am]

BILLING CODE 5000–04–M