Federal Register / Vol. 66, No. 126 / Friday, June 29, 2001 / Notices 34693

Provision of Medicare, Medicaid, and SCHIP Benefits

Improvement and Protection Act of 2000 (BIPA)

Additional FY 2002 Medicare

Home Health Estimated Expenditures Due to the BIPA

Provision

Section 501—additional year delay of 15-percent reduction ..................................................................................... $890 million.

Section 502—restoration of full home health market basket in FY 2001 .................................................................. $170 million.

Section 508—10-percent rural add-on for Medicare home health services furnished in a rural area ...................... $310 million.

FY 2002 Update to Home Health PPS Rates Required by the Act

Additional FY 2002 Medicare Home Health Estimated Expenditures Due to

Annual Update Required by

Law

Section 1895(b)(3)(B) of the Act requires HH PPS rates increased by home health market basket minus 1.1 percentage points in FY 2002 (2.5% increase).$350 million.

2. Effects on Providers

This notice with comment period will

have a positive effect on providers of

Medicare home health services by

increasing their rate of Medicare

payment. We do not anticipate specific

effects on other providers. This notice

with comment period reflects the

statutorily required annual update to the

HH PPS rates published in the July 3,

2000 final rule. Also, as discussed

above, this notice with comment period

provides an update to all Medicare

HHAs. We do not believe there is a

differential impact due to the consistent

and aggregate nature of the update.

C. Alternatives Considered

As discussed in section II, this notice

with comment period reflects an annual

update to the HH PPS rates as required

by statute. Due to the lack of discretion

provided in the statutory requirements

governing this notice with comment

period, we believe the statute provides

no latitude for alternatives other than

the approach set forth in this notice

reflecting the FY 2002 annual update to

the HH PPS rates. Also, as discussed in

section II for clarification, this notice

addresses the 10 percent rural add-on

required under section 508 of the BIPA

for home health services furnished to

beneficiaries who reside in a rural nonMSA area. Other than the positive effect

of the market basket increase, this notice

with comment will not have a

significant economic impact nor will it

impose an additional burden on small

entities. When a regulation or notice

imposes additional burden on small

entities, we are required under the RFA

to examine alternatives for reducing

burden. Since this notice with comment

period will not impose an additional

burden, we have not examined

alternatives.

D. Conclusion

We have examined the economic

impact of this notice with comment

period on small entities and have

determined that the economic impact is

positive, significant, and that all HHAs

will be affected. To the extent that small

rural hospitals are affiliated with HHAs,

the impact on these facilities will also

be positive. Finally, we have

determined that the economic effects

described above are largely the result of

the BIPA provisions which this notice

serves to announce.

We continue to analyze the

appropriateness and accuracy of

payments for differing case mixes. In the

fall of 2001, we intend to undertake a

re-evaluation of the OASIS reporting

system’s utility in ensuring more

accurate and equitable PPS payments.

In accordance with the provisions of

notice with comment Executive Order

12866, this was reviewed by the Office

of Management and Budget.

(Catalog of Federal Domestic Assistance

Program No. 93.773, Medicare—Hospital

Insurance; and Program No. 93.774,

Medicare—Supplementary Medical

Insurance Program)

Dated: March 15, 2001.

Michael McMullan,

Acting Deputy Administrator, Health Care

Financing Administration.

Dated: April 23, 2001.

Tommy G. Thompson,

Secretary.

[FR Doc. 01–16384 Filed 6–28–01; 8:45 am]

BILLING CODE 4120–01–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

[HCFA–1186–N]

Medicare Program; Public Meeting for

New Clinical Laboratory Tests—

Payment Determinations for Calendar

Year 2002

AGENCY: Health Care Financing

Administration (HCFA), HHS.

ACTION: Notice of meeting.

SUMMARY: This notice announces a

public meeting to discuss the

assignment of payment rates for specific

new Current Procedural Terminology

(CPT) codes for clinical laboratory tests.

These codes will be included in

Medicare’s Clinical Laboratory Fee

Schedule for calendar year 2002, which

will be effective on January 1, 2002. The

meeting is directed towards the

discussion of technical issues relating to

payment determinations for a specified

list of new codes, and discussion will be

limited to the codes on that list.

DATES: The Meeting: August 6, 2001,

from 8:30 a.m. until 4 p.m., E.D.T.

Deadline for Registration: Individuals

may register by sending a fax to the

attention of Anita Greenberg at (410)

786–0169, no later than July 25, 2001.

Please provide name, company name,

address, telephone number, and

indicate whether interested in making

an oral presentation.

Special Accommodations: Persons

attending the meeting who are hearing

or visually impaired and have special

requirements, or a condition that

requires special assistance or

accommodations, should notify Anita

Greenberg at fax number (410) 786–0169

or at telephone number (410) 786–4601

so that accommodations can be made.

ADDRESSES: The Meeting: The meeting

will be held at the Health Care

Financing Administration (HCFA)

Auditorium, 7500 Security Boulevard,

Baltimore, Maryland 21244.

Website: A summary of the meeting

will be posted on HCFA’s Internet

website (www.hcfa.gov) within 1 month

after the meeting.

General Information: The meeting

will be held in a government building;

therefore, security measures will be

applicable. Anyone without government

identification will need to present photo

identification, sign-in, and supply

registration information.

34694 Federal Register / Vol. 66, No. 126 / Friday, June 29, 2001 / Notices

FOR FURTHER INFORMATION CONTACT:

Anita Greenberg (410) 786–4601

(telephone); (410) 786–0169 (fax).

SUPPLEMENTARY INFORMATION: On

December 21, 2000, the Congress passed

the Medicare, Medicaid, and SCHIP

Benefits Improvement and Protection

Act of 2000 (BIPA), Pub. L. 106–554.

Section 531 of BIPA mandates that we

establish, no later than 1 year after the

date of enactment, procedures for

coding and payment determinations for

new clinical diagnostic laboratory tests

under Part B of title XVIII of the Social

Security Act (the Act) that permit public

consultation. In addition, section 531

specifies that the procedures for coding

and payment that permit public

consultation be conducted in a manner

consistent with the procedures

established for implementing coding

modifications for International

Classification of Diseases (ICD–9–CM).

The procedures to be implemented

according to section 531 of BIPA are

still under development. The public

meeting announced in this notice will

provide experience that will help

inform the development of the

procedures mandated by section 531 of

BIPA for public consultation on

payment of new clinical laboratory tests.

Meeting Topic

The introduction of new codes

requires us to determine the rates at

which the new codes will be paid. The

meeting is intended to provide us with

expert input on the nature of new tests

before these determinations are made so

that these decisions can be better

informed. Discussion will be limited to

the codes listed below. The nature of the

payment determinations is described

more fully in the background section,

which follows.

The following is a list of new codes

that will be discussed at the meeting.

Final determinations for the actual

numbering of the codes had not yet been

completed at the time of publication of

this notice. However, the identifying

information we have included in this

notice should be sufficient for those

knowledgeable in coding for clinical

laboratory services to be able to discuss

the assignment of payment for the new

codes. The list of newly created CPT

codes for the calendar year 2002 is as

follows:

Chemistry

• Code 82xxx: Blood, occult, by fecal

hemoglobin determination by

immunoassay, qualitative, feces, 1–3

simultaneous determinations.

• Code 86683: (deleted).

• Code 83xxx: Oncoprotein, HER–2

neu (For tissue, see codes 88342 and

88365).

Immunology

• Code 86140: C-reactive protein;

Code xxxxx: high sensitivity (hsCRP).

• Code 863xx: Inhibin A.

• Code 871xx: Cytomegalovirus direct

fluorescent antibody (DFA).

• Code 871xx: Enterovirus direct

fluorescent antibody (DFA).

Microbiology

• Code 878xx: Infectious agent

antigen detection by immunoassay with

direct optical observation;

Streptococcus, group B.

Code xxxxx: Clostridium difficile

toxin A.

Code xxxxx: Influenza.

• Code 87901: Infectious agent

genotype analysis by nucleic acid (DNA

or RNA): HIV1, reverse transcriptase

and protease.

Code xxxxx: Hepatitis C virus.

Procedure and Agenda

This meeting is open to the public.

The on-site registration will be held

from 8:30 a.m. to 9 a.m., followed by

opening remarks. Registered persons

from the public may present discussion

and individual recommendations on

payment determinations for specific

new Current Procedural Terminology

(CPT) codes for the 2002 Clinical

Laboratory Fee Schedule, which is to

become effective January 1, 2002. A

newly created CPT code can either

represent a refinement or modification

of existing test methods, or a

substantially new test method.

Decisions regarding payment levels or

methods for determining them for the

newly created CPT codes will not be

made at this meeting. However, the

meeting will provide an opportunity for

us to receive public input before we

determine payments for the new codes.

All discussions should be brief, and a

written version should accompany any

oral presentation. Information we find

helpful for presenters to address

includes the nature of the test method,

applications, costs, and any

recommendation the presenter may

have regarding the method for

establishing a payment rate (as

discussed below). Due to time

constraints, we may limit the number

and duration of oral presentations to fit

the time available.

Background

The Deficit Reduction Act of 1984

(DEFRA) established prospectively set

local fee schedules for outpatient

clinical diagnostic laboratory services to

be paid under the Medicare Part B

benefit under section 1833(h) of the Act.

According to section 1833 of the Act,

payment for those services is the lower

of the submitted charge, the national

limitation amount, or the local fee

schedule amount for a laboratory

service. Each local fee schedule is

developed by the carrier, that is, the

local contractor that processes Medicare

Part B claims for a designated

geographic area, using the 1983

customary charge data for existing

payment codes.

Carriers continue to pay laboratory

claims primarily from independent

freestanding laboratories and physician

office laboratories. Intermediaries use

the same fee schedules as carriers when

paying for outpatient laboratory tests

performed by hospitals, nursing homes,

and end-stage renal disease centers.

Payment is only made to laboratories

that are certified to perform laboratory

services under the Clinical Laboratory

Improvement Amendments (CLIA)

under section 353 of the Public Health

Service Act.

To enhance efficiencies in setting

payment rates, we gather the carriers’

local fee schedules into one data set

referred to as the Clinical Laboratory

Fee Schedule. By the 1st of November

of each year, we update payments for

inflation, when appropriate, and

incorporate new payment codes into the

data set, assign a payment rate to the

new codes, and distribute the data set to

the carriers and intermediaries

electronically. In addition, we issue a

corresponding Program Memorandum

announcing the new codes and payment

rates. The Program Memorandum lists

an address for the public to send

comments for the development of the

following year’s Clinical Laboratory Fee

Schedule. We also make the data set and

Program Memorandum available to the

public through the Internet website at

http://www.hcfa.gov. During the months

of November and December, carriers,

intermediaries, and laboratories upload

the new data set, educate their

customers, and test their claims systems

in order to be ready for the new

calendar year Clinical Laboratory Fee

Schedule that will be effective on the

1st of January.

Payment Rates

Medicare pays the lesser of actual

charges, the local carrier fee schedule

amount, or a national limitation amount

based on the local fee schedule

amounts. The national limitation

amount or maximum payment amount

for each laboratory test is equal to a

percentage specified by statute of the

median of all carriers’ local fee schedule

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