[Federal Register Volume 66, Number 126 (Friday, June 29, 2001)]
[Notices]
[Pages 34693-34695]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-16370]


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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.

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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.

[[Page 34694]]


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

    <bullet> Code 82xxx: Blood, occult, by fecal hemoglobin 
determination by immunoassay, qualitative, feces, 1-3 simultaneous 
determinations.
    <bullet> Code 86683: (deleted).
    <bullet> Code 83xxx: Oncoprotein, HER-2 neu (For tissue, see codes 
88342 and 88365).

Immunology

    <bullet> Code 86140: C-reactive protein;
    Code xxxxx: high sensitivity (hsCRP).
    <bullet> Code 863xx: Inhibin A.
    <bullet> Code 871xx: Cytomegalovirus direct fluorescent antibody 
(DFA).
    <bullet> Code 871xx: Enterovirus direct fluorescent antibody (DFA).

Microbiology

    <bullet> Code 878xx: Infectious agent antigen detection by 
immunoassay with direct optical observation; Streptococcus, group B.
    Code xxxxx: Clostridium difficile toxin A.
    Code xxxxx: Influenza.
    <bullet> 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

[[Page 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:
    <bullet> 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.
    <bullet> 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