Federal Register / Vol. 66, No. 126 / Friday, June 29, 2001 / Notices 34695

amounts. For calendar year 2002,

section 1833(h) of the Act requires the

national limitation amount for each test

to be established at 74 percent of the

median of all local laboratories’ fee

schedule amounts, or 100 percent of the

median in the case of a clinical

diagnostic laboratory test performed on

or after January 1, 2001, that the

Secretary determines is a new test for

which no limitation amount has

previously been established.

Payment Codes

The codes used on the Clinical

Laboratory Fee Schedule are largely the

CPT codes that are developed and

published by the American Medical

Association (AMA). The codes are a

listing of descriptive terms for reporting

clinical laboratory tests. The AMA

publishes the updated codes (through

books and magnetic tape) every year in

October for use by payers and providers

for the upcoming calendar year.

Approximately 1,000 separate clinical

laboratory codes are currently listed in

the 80000–89399 CPT code series. In

addition, the Clinical Laboratory Fee

Schedule contains a small number (less

than 50) of HCFA’s Common Procedure

Coding System (HCPCS) alpha-numeric

codes that are developed by the Blue

Cross and Blue Shield Association

(BCBSA), the Health Insurance

Association of America (HIAA), and

HCFA. These codes were created to

include clinical laboratory codes that

are unique to the Medicare payment

system. An example of this type of code

is G0103, prostate cancer screening;

prostate specific antigen blood test. This

alphanumeric code was introduced

effective January 1, 2000, to implement

section 4103 of the Balanced Budget Act

of 1997 that mandates additional

coverage and tracking of expenditures

for this type of test for Medicare

beneficiaries.

The AMA’s CPT Editorial Panel has

procedures for receiving requests to

change codes and conducts meetings to

review the requests. The CPT codes are

updated annually to reflect changes in

the practice of medicine and provision

of health care. A request for a code

change may be submitted by any

interested party. The CPT meetings

occur several times a year and result in

annual additions, deletions, and

modifications of codes. By June of each

year, the CPT Editorial Panel has largely

completed its coding decisions for the

upcoming calendar year. In the past, to

accord with the AMA CPT publication

schedule, we have not been able to

make the new codes publicly available

until October. This constraint did not

permit us sufficient time to seek public

input on the determination of pricing of

new codes before we had to transmit the

new fee schedule to our contractors.

However, this year the AMA has agreed

to make the codes available in draft

during the summer so that we can

proceed with this meeting to obtain

public input.

Two methods for determining the

payment rates for new codes are

available, which may be summarized as

follows:

• In the first method, called ‘‘cross

walking,’’ we determine a new test to be

similar to an existing test, multiple

existing test codes, or a portion of an

existing test code. The new test code is

then assigned the related existing local

fee schedule amounts and resulting

national limitation amount. In some

instances, we determine that a test may

only equate to a portion of an existing

test, and, in those instances, we specify

payment at an appropriate percentage of

the payment for the existing test.

• The second method, called ‘‘gap

filling,’’ is used when no comparable,

existing test is available. We then

instruct each Medicare carrier to

determine a payment amount for its area

for use in the first year. Then, we use

the carrier-specific amounts to establish

a national limitation amount for the

following year.

For each new code, we must

determine whether it is appropriate to

cross walk or to gap fill, and, if cross

walking is appropriate, we need to

know what tests to which to cross walk.

These are the decisions on which we

will seek public input at this meeting.

Authority: Section 1102 and 1871 of the

Social Security Act (42 U.S.C. 1302 and 42

U.S.C. 1395hh)

(Catalog of Federal Domestic Assistance

Program No. 93.774, Medicare—

Supplementary Medical Insurance Program)

Dated: June 22, 2001.

Thomas A. Scully,

Administrator, Health Care Financing

Administration.

[FR Doc. 01–16370 Filed 6–28–01; 8:45 am]

BILLING CODE 4120–01–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

Government-Owned Inventions;

Availability for Licensing

AGENCY: National Institutes of Health,

Public Health Service, DHHS.

ACTION: Notice.

SUMMARY: The inventions listed below

are owned by agencies of the U.S.

Government and are available for

licensing in the U.S. in accordance with

35 U.S.C. 207 to achieve expeditious

commercialization of results of

federally-funded research and

development. Foreign patent

applications are filed on selected

inventions to extend market coverage

for companies and may also be available

for licensing.

ADDRESSES: Licensing information and

copies of the U.S. patent applications

listed below may be obtained by writing

to the indicated licensing contact at the

Office of Technology Transfer, National

Institutes of Health, 6011 Executive

Boulevard, Suite 325, Rockville,

Maryland 20852–3804; telephone: 301/

496–7057; fax: 301/402–0220. A signed

Confidential Disclosure Agreement will

be required to receive copies of the

patent applications.

Structure Determination of Materials

Using Electron Microscopy

Sriram Subramaniam (NCI)

[DHHS Reference No. E–187–01/0 filed 23

Apr 2001]

Licensing Contact: Dale Berkley; 301/

496–7735 ext. 223; e-mail:

berkleyd@od.nih.gov

The invention is a method for

automating the acquisition of electron

microscopic images from a desktop

computer interface to provide for data

collection by any user from any

location. Automated low-dose image

acquisition procedures are used to

record high-resolution images on either

film or CCD, at desired defocus values,

and under conditions that satisfy userspecified limits for drift rates of the

specimen stage. In a fully automated

procedure of the invention, the

determination of regions suitable for

imaging are carried out automatically

using spiral search algorithms. All steps

subsequent to insertion of the specimen

in the microscope can be carried out on

a remote personal computer connected

to the microscope computer via the

Internet.

Lever Coil Sensor for Respiratory and

Cardiac Motion

Kenneth W. Fishbein (NIA)

DHHS Reference No. E–134–01/0 filed 30

Mar 2001]

Licensing Contact: Dale Berkley; 301/

496–7735 ext. 223; e-mail:

berkleyd@od.nih.gov

The invention is a device that

generates a signal for synchronizing an

MRI scanner with a subject’s respiratory

and cardiac motion to prevent blurring

of the image during the scan. This

device uses a small electromagnetic

pickup coil to simultaneously sense

34696 Federal Register / Vol. 66, No. 126 / Friday, June 29, 2001 / Notices

respiratory and cardiac motion and

provide a synchronization signal. The

invention uses a mechanical linkage to

keep the pickup coil far from the center

of the scanner’s radio frequency and

gradient coils, thereby eliminating

artifacts in the sensor signal and

magnetic resonance images caused by

mutual inductance. The signal

generated by this device is proportional

to chest velocity rather than chest height

and is, therefore, free of any offset

voltages, permitting peak location with

a simple threshold detector, and is large

in amplitude even for small animal

subjects. The invention operates

without the need for any electrical leads

inside the magnet and thus eliminates

any burn hazards for the patient. This

device provides an inexpensive

alternative to commercially available

bellows sensors and fiber optically

coupled units. Unlike competing

sensors, this invention can be inserted,

removed, or adjusted without removing

the subject from the magnet and can

operate with the subject in a prone or

supine position. This invention has

applications in both animal and human

imaging studies.

Vessel Surface Reconstruction With a

Tubular Deformable Model

Yim et al. (CC)

[DHHS Reference No. E–239–01/0 filed 15

Feb 2001]

Licensing Contact: Dale Berkley; 301/

496–7735 ext. 223; e-mail:

berkleyd@od.nih.gov

The invention is a method for

modeling a carotid or renal artery to

measure stenosis from 3D angiographic

data that may otherwise exhibit limited

image resolution and contrast. The

method reconstructs vessel surfaces

from 3D angiographic data using a

deformable model that employs a

tubular coordinate system. Vertex

merging is incorporated into the

coordinate system to maintain even

vertex spacing and to avoid problems of

self-intersection of the surface. This

method produces reconstructed surfaces

that have a realistic smooth appearance

and accurately represent vessel shape.

The method allows for an objective

evaluation of vessel shape and may

improve the precision of shape

measurements from 3D angiography.

This abstract revises one published in

the Federal Register on Tuesday, May

20, 2001 (66 FR 29154) as DHHS

Reference No. E–202–00/1.

Development of Mutations Useful for

Attenuating Dengue Viruses and

Chimeric Dengue Viruses

Stephen S. Whitehead, Brian R.

Murphy, Kathryn A. Hanley, Joseph E.

Blaney Jr. (NIAID)

[DHHS Reference No. E–120–01/0 filed 22

May 2001]

Licensing Contact: Carol Salata; 301/

496–7735 ext. 232; e-mail:

salatac@od.nih.gov

Although flaviviruses cause a great

deal of human suffering and economic

loss, there is a shortage of effective

vaccines. This invention relates to

dengue virus mutations that may

contribute to the development of

improved dengue vaccines. Site directed

and random mutagenesis techniques

were used to introduce mutations into

the dengue virus genome and to

assemble a collection of useful

mutations for incorporation in

recombinant live attenuated dengue

virus vaccines. The resulting mutant

viruses were screened for several

valuable phenotypes, including

temperature sensitivity in Vero cells or

human liver cells, host cell restriction in

mosquito cells or human liver cells, host

cell adaptation for improved replication

in Vero cells, and attenuation in mice or

in mosquitoes. The genetic basis for

each observed phenotype was

determined by direct sequence analysis

of the genome of the mutant virus.

Mutations identified through these

sequencing efforts have been further

evaluated by re-introduction of the

identified mutations, singly, or in

combination, into recombinant dengue

virus and characterization of the

resulting recombinant virus for

phenotypes. In this manner, a menu of

attenuating and growth promoting

mutations was developed that is useful

in fine-tuning the attenuation and

growth characteristics of dengue virus

vaccine candidates. The mutations

promoting growth in Vero cells have

usefulness for the production of live or

inactivated dengue virus vaccines.

Subgenomic Replicons of the Flavivirus

Dengue

Xiaowu Pang (CBER/FDA)

[DHHS Reference No. E–228–00/0 filed 09

Mar 2001]

Licensing Contact: Carol Salata; 301/

496–7735 ext. 232; e-mail:

salatac@od.nih.gov

Dengue virus, with its four serotypes

Den-1 to Den-4, is the most important

member of the Flavivirus genus with

respect to infection of human producing

diseases that range from flu-like

symptoms of dengue fever (DF) to severe

or fatal illness of dengue hemorrhagic

fever (DHF) and dengue shock

syndrome (DSS). Dengue outbreaks

continue to be a major public health

problem in densely populated areas of

the tropical and subtropical regions,

where mosquito vectors are abundant.

This invention relates to the

construction of all four types of dengue

subgenomic replicons (chromosome and

plasmid which contain genetic

information necessary for their own

replication) containing large deletions

in the structural region (C-preM-E) of

the genome. Immunization using these

replicons should be effective in eliciting

not only a humoral-mediated immune

response but also a cell-mediated

immune response. These replicons

should be safer than a live attenuated

vaccine because they cannot cause

disease in the host and they should be

better than subunit vaccines because

they can replicate in the host.

Dated: June 22, 2001.

Jack Spiegel,

Director, Division of Technology Development

and Transfer, Office of Technology Transfer,

National Institutes of Health.

[FR Doc. 01–16366 Filed 6–28–01; 8:45 am]

BILLING CODE 4140–01–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

National Cancer Institute; Notice of

Closed Meeting

Pursuant to section 10(d) of the

Federal Advisory Committee Act, as

amended (5 U.S.C. Appendix 2), notice

is hereby given of a meeting of the

Board of Scientific Counselors, National

Cancer Institute.

The meeting will be closed to the

public as indicated below in accordance

with the provisions set forth in section

552b(c)(6), Title 5 U.S.C., as amended

for the review, discussion, and

evaluation of individual intramural

programs and projects conducted by the

National Cancer Institute, including

consideration of personnel

qualifications and performance and the

competence of individual investigators,

the disclosure of which would

constitute a clearly unwarranted

invasion of personal privacy.

Name of Committee: Board of Scientific

Counselors, National Cancer Institute,

Subcommittee A-Clinical Sciences and

Epidemiology.

Date: July 23, 2001.

Time: 9 am to 3:30 p.m.

Agenda: To review and evaluate personal

qualifications and performance, and

competence of individual investigators.