[Federal Register Volume 66, Number 226 (Friday, November 23, 2001)]
[Notices]
[Pages 58743-58745]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-29326]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-1190-NC]


Medicare Program; Establishment of Procedures That Permit Public 
Consultation Under the Existing Process for Making Coding and Payment 
Determinations for New Clinical Laboratory Tests and for New Durable 
Medical Equipment

AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.

ACTION: Notice of public meetings with comment period.

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SUMMARY: This notice announces the addition of public meetings under 
our existing process for making coding and payment determinations for 
new clinical laboratory tests and new durable medical equipment (DME). 
Section 531(b) of the Medicare, Medicaid, and SCHIP Benefits 
Improvement and Protection Act of 2000(BIPA) requires us to establish 
procedures that permit public consultation for coding and payment 
determinations for new clinical laboratory tests and for new DME in a 
manner consistent with the procedures established for implementing 
coding modifications for International Classification of Diseases (ICD-
9-CM).
    In addition, this notice announces the dates and general details of 
public meetings to be held in 2002. We are requesting comments on our 
plan to fulfill the requirements of section 531(b) of BIPA.

DATES: Laboratory Public Meeting: The meeting regarding the assignment 
of payment rates for new laboratory tests to be included in Medicare's 
Clinical Laboratory Fee Schedule for calendar year 2003 is scheduled 
for Monday, August 5, 2002. The meeting will begin at 8:30 a.m. and end 
at 4:30 p.m., E.S.T. The development of the codes for clinical 
laboratory tests is largely performed by the Current Procedural 
Terminology (CPT) Editorial Panel and will not be further discussed at 
the CMS meeting.
    DME Public Meeting Dates: There will be three meetings regarding 
coding and payment for new DME. The meetings are scheduled for March 
11, 2002, May 13, 2002, and June 17, 2002. All three meetings will 
begin at 8 a.m. and end at 5 p.m., E.S.T.
    Comment Date: We are requesting comments on the procedures in this 
notice for establishing public consultation on our existing coding and 
payment determinations for new clinical laboratory tests and new DME. 
Comments will be considered if we receive them at the appropriate 
address, as provided below, no later than 5 p.m. on January 22, 2002.

ADDRESSES: Meetings: All four meetings in 2002 will be held at the 
Centers for Medicare & Medicaid Services, CMS Auditorium, 7500 Security 
Boulevard, Baltimore, MD 21244.
    Website: For clinical laboratory tests, a summary of the August 
2002 meeting will be posted on our website (www.hcfa.gov/audience/planprov.htm) within 1 month after the meeting.
    For DME items, you may access up-to-date meeting information on the 
HCPCS website at: http://www.hcfa.gov/medicare/hcpcs.htm.
    Comments: Mail an original and three copies of written comments to 
the following address ONLY: Centers for Medicare & Medicaid Services, 
Department of Health and Human Services, Attention: CMS-1190-NC, P.O. 
Box 8017, Baltimore, MD 21244-8017.
    To ensure that mailed comments are received in time for us to 
consider them, please allow for possible delays in delivering them. If 
you prefer, you may deliver an original and three copies of your 
written comments to one of the following addresses: Room 443-G, Hubert 
H. Humphrey Building, 200 Independence Avenue, SW., Washington, DC 
20201, or Room C5-14-03, 7500 Security Boulevard, Baltimore, MD 21244-
1850.
    (Because access to the interior of the HHH Building is not readily 
available to persons without Federal Government identification, 
commenters are encouraged to leave their comments in the CMS drop slots 
located in the main lobby of the building. A stamp-in clock is 
available for commenters wishing to retain a proof of filing by 
stamping in and retaining an extra copy of the comments being filed.)
    Because of staff and resource limitations, we cannot accept 
comments by facsimile (FAX) transmission. In commenting, please refer 
to file code CMS-1190-NC. For information on viewing public comments, 
see the beginning of the SUPPLEMENTARY INFORMATION section.

FOR FURTHER INFORMATION CONTACT: Anita Greenberg, (410) 786-4601 for 
clinical laboratory payment rates; Kaye Riley, (410) 786-5323 for HCPCS 
coding for DME items; Joel Kaiser, (410) 786-4499 for DME payment 
rates.

SUPPLEMENTARY INFORMATION:

I. Background

    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(b) of BIPA mandates that we establish, no later 
than 1 year after the date of enactment, procedures that permit public 
consultation for coding and payment determinations for new clinical 
diagnostic laboratory tests and new DME under Part B of title XVIII of 
the Social Security Act (the Act) in a manner consistent with the 
procedures established for implementing coding modifications for ICD-9-
CM. The ICD-9-CM process involves holding regularly scheduled public 
meetings that are announced in the Federal Register 30 days before the 
meeting date. The ICD-9-CM meetings are open to the public and are held 
in the CMS auditorium. The agenda for each meeting is posted on the CMS 
website before each meeting under the heading for meetings and 
announcements. A preliminary ICD-9-CM coding determination for each 
agenda item is presented by CMS at the meeting.
    The procedures and public meetings announced in this notice for new 
clinical laboratory tests and new DME are in response to the mandate of 
section 531(b) of BIPA. Also, our HCPCS website at http//www.hcfa.gov/
medicare/hcpcs.htm includes a description of our existing HCPCS

[[Page 58744]]

coding process and the additional public consultation process. The 
website provides a detailed explanation of the procedures we use to 
make coding and payment determinations for DME and other items and 
services that are coded in the HCPCS. We may make modifications to our 
process in the future as a result of comments we receive or based on 
our experience in implementing these procedures in 2002 and subsequent 
years.

II. Public Meetings

Registration

    Deadline for Registration: Individuals must register for the 
meetings by the following dates:

 
             DME meeting dates                   Registration dates
 
March 11, 2002............................  January 28, 2002.
May 13, 2002..............................  April 1, 2002.
June 17, 2002.............................  May 3, 2002.
 


 
          Laboratory meeting date                 Registration date
 
August 5, 2002............................  July 24, 2002.
 

Presentations

    Laboratory Agenda Item: Individuals who want to make a presentation 
on the Laboratory agenda item must register by sending a fax to the 
attention of Anita Greenberg at (410) 786-0169, no later than July 24, 
2002. Please provide name, company name, address, and telephone number.
    DME Agenda Item: Individuals who want to make presentations on a 
DME agenda item must register by sending a fax to the attention of Joel 
Kaiser at (410) 786-0765, by the registration dates listed above. 
Please provide name, company name, address, telephone number, and 
agenda item you want to address.
    The agenda will consist of HCPCS coding requests for new DME. 
Requests must be submitted through the HCPCS coding process to Kaye 
Riley; Center for Medicare Management; Centers for Medicare & Medicaid 
Services; 7500 Security Boulevard; Mail Stop C5-08-27; Baltimore, MD 
21244. Requests must be received by April 1 of each year in order to be 
considered during the review cycle for the next annual HCPCS update. 
The annual HCPCS update is January 1 of each year. Requests will be 
reviewed by CMS's HCPCS Alpha-Numeric Workgroup, which will make CMS's 
preliminary recommendation on what action needs to be taken in response 
to the request. Once the Workgroup's preliminary recommendation has 
been developed, the request will be added to the agenda for the next 
available public meeting.

General Information

    The meetings 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 
provide registration information.
    Persons attending the meetings in Baltimore who are hearing or 
visually impaired and have special requirements or a condition that 
requires special assistance or accommodations, should notify the 
individuals listed below.
    Laboratory Meeting: Anita Greenberg at fax number (410) 786-0169 or 
call (410) 786-4601.
    DME Meetings: Joel Kaiser at fax number (410) 786-0765 or call 
(410) 786-4499.

Purpose of the Meetings

    New Laboratory Tests: The introduction of new codes may call for us 
to determine the rates at which the new codes will be paid. The 
laboratory meeting is intended to provide us with expert input on the 
nature of new tests before rate determinations are made. Discussion 
will be limited to the codes listed on the CMS Internet website at 
www.hcfa.gov/audience/planprov.htm by June 26, 2002.
    New DME: Beginning in March 2002, CMS plans to schedule three 
public meetings per year on coding and pricing of new DME that will 
allow interested parties the opportunity to make oral presentations and 
submit written comments regarding coding and pricing recommendations 
for new DME that have been submitted using the HCPCS coding 
modification process. These public meetings will be held during the 
months of March, May, and June. Each meeting will be a full day.
    Before each public meeting, the HCPCS workgroup will meet to review 
the coding requests that will be on the agenda for the next public 
meeting. In advance of a meeting, the Workgroup will complete a fact 
sheet that will include the following information for each agenda item:
     The nature of the request for a coding modification.
     Background information pertinent to the request.
     The fact sheet will also include for each request on the 
agenda the HCPCS workgroup's preliminary recommendation, and the 
rationale for this recommendation.
    In addition, the fact sheet will also include the Workgroup's 
preliminary recommendation regarding the applicable payment category 
and the methodology that will be used to set a payment amount, for 
example, supplier price lists, price of a comparable item, or 
reasonable charge data. The preliminary recommendations of the HCPCS 
workgroup regarding the coding requests and CMS's preliminary payment 
methodology decision will be presented at the public meetings for 
discussion. After a public meeting, the workgroup will reconsider its 
preliminary coding recommendations, and CMS staff will reconsider 
pricing recommendations in view of the information presented at the 
public meeting. After reconsidering its preliminary coding 
recommendations in light of the discussions at the public meeting, the 
workgroup will decide what recommendations it should make to the HCPCS 
National Alpha-Numeric Editorial Panel, the entity that maintains the 
permanent HCPCS level II codes and that is hereafter referred to as the 
National Panel. The HCPCS National Panel is comprised of the Health 
Insurance Association of America, the Blue Cross and Blue Shield 
Association, and CMS.

Format and Agenda

    New Laboratory Tests: This meeting is open to the public. The on-
site check-in for visitors who have registered to attend the meeting 
will be held from 8 a.m. to 8:30 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-4) codes for the 2003 Clinical 
Laboratory Fee Schedule, which are to become effective January 1, 2003. 
A newly created CPT-4 code can represent either 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-4 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 presentations should be brief, and three written copies should be 
submitted to accompany any oral presentations. 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. The specific codes 
that will be discussed at the meeting will be identified on the CMS 
Internet

[[Page 58745]]

website at www.hcfa.gov/audience/planprov.htm by June 26, 2002.
    New DME: This meeting is open to the general public. The on-site 
check-in for visitors who have registered to attend the meeting will be 
held from 7:30 a.m. to 8 a.m., followed by opening remarks. The purpose 
of the open meeting is to allow the public an opportunity, in a public 
forum, to do the following:
     Present to CMS representatives information and 
recommendations regarding the coding requests listed on the agenda.
     Discuss with representatives of the HCPCS Workgroup its 
preliminary recommendation regarding these coding requests.
     Discuss preliminary recommendations of CMS regarding 
payment for new DME items.
    For each item on the agenda, the discussion will begin with CMS's 
presenting an overview of the request and the factors we considered in 
reaching our preliminary recommendations. Following the CMS overview, 
the entity that requested the HCPCS coding change will be given a 
maximum of 15 minutes to make a public presentation concerning its 
coding change application and payment for the item. For a requestor to 
participate in the public meeting as a primary presenter, the requestor 
must be registered with the HCPCS Coordinator, Kaye Riley, (410) 786-
5323. For purposes of registering as a primary presenter, you must, at 
least 15 days prior to the meeting, submit the following to the HCPCS 
coordinator:
     A brief statement, one to two pages, of the general nature 
of the information you plan to present.
     The names and addresses of the proposed presenters.
     An estimate of the time required to make the presentation.
    Primary presenters will be given up to 15 minutes for their 
presentations. Other presenters will be permitted to sign up at the 
meeting on a first come basis to make 5-minute presentations on agenda 
items. Time constraints will determine how many presenters, besides the 
primary presenter, will be allowed to make a public presentation. 
Speakers following the primary presenters will also be required to 
submit on the day of the meeting a one to two-page summary of their 
presentation. Other persons in attendance, who do not have the 
opportunity to make a presentation, may, at the meeting, submit their 
comments in a written statement of one to two typed pages.
    We will request that speakers declare at the meeting and in any 
written statements whether or not they have any financial involvement 
with manufacturers of any items or services being discussed (or with 
their competitors). This would include any payment, salary, 
remuneration, or benefit provided to the speaker by the manufacturer. A 
summary of each meeting will be posted on the HCPCS website within 3 
weeks following the meeting. The HCPCS website is http://www.hcfa.gov/medicare/hcpcs.htm.
    The DME public meetings will be held in the main auditorium at 
CMS's Central Office, located at 7500 Security Boulevard, Baltimore, 
MD, 21244. The first meeting is scheduled for March 11, 2002. For the 
remainder of 2002, meetings are also scheduled for May 13 and June 17. 
The meetings will begin at 8 a.m., E.S.T. For a coding request to be 
included on the agenda for the May or June meeting, it must received by 
April 1. For a coding request to be included on the agenda for the 
March meeting, it must be received at least 45 days before the 
scheduled date of the March meeting. If a coding request does not meet 
this deadline, it will be placed on the agenda for the next meeting.
    The agenda for an upcoming DME public meeting will be posted on the 
HCPCS website at least 30 days before the scheduled date for the 
meeting. Posted with the agenda, there will also be a fact sheet, as 
described above, for each coding request to be reviewed at the meeting.

    Authority: Sections 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: November 19, 2001.
Thomas A. Scully,
Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 01-29326 Filed 11-21-01; 8:45 am]
BILLING CODE 4120-01-P