Medicare Program; Public Meeting in Calendar Year 2005 for New Clinical Laboratory Tests Payment Determinations, 30734-30735 [05-10263]

Download as PDF 30734 Federal Register / Vol. 70, No. 102 / Friday, May 27, 2005 / Notices Nicollet Institute for Research and Education; Dr. David Lansky, Director, Health Program, Markle Foundation; Donald J. Lott, Executive Director, Indian Family Health Clinic; Dr. Frank I. Luntz, President and Chief Executive Officer, Luntz Research Companies; Dr. Daniel Lyons, Senior Vice President, Government Programs, Independence Blue Cross; Katherine Metzger, Director, Medicare and Medicaid Programs, Fallon Community Health Plan; Dr. Keith Mueller, Professor and Section Head, Health Services Research and Rural Health Policy, University of Nebraska; David Null, Financial Advisor, Merrill Lynch; Lee Partridge, Senior Health Policy Advisor, National Partnership for Women and Families; Dr. Marlon Priest, Professor of Emergency Medicine, University of Alabama at Birmingham; Susan O. Raetzman, Associate Director, Public Policy Institute, AARP; Catherine Valenti, Chairperson and Chief Executive Officer, Caring Voice Coalition, and Grant Wedner, Senior Director, New Services Department, WebMD. The agenda for the June 21, 2005, meeting will include the following: • Recap of the previous meeting (March 22, 2005). • Centers for Medicare & Medicaid Services update. • Medicare Modernization Act: Education and outreach strategies. • Public comment. • Listening session with CMS leadership. • Next steps. Individuals or organizations that wish to make a 5-minute oral presentation on an agenda topic should submit a written copy of the oral presentation to Lynne Johnson, Health Insurance Specialist, Division of Partnership Development, Center for Beneficiary Choices, Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Mail stop S2–23– 05, Baltimore, MD 21244–1850 or by email at Lynne.Johnson@cms.hhs.gov, no later than 12 noon, e.d.t., June 14, 2005. The number of oral presentations may be limited by the time available. Individuals not wishing to make a presentation may submit written comments to Ms. Johnson by 12 noon, (e.d.t.), June 14, 2005. The meeting is open to the public, but attendance is limited to the space available. Special Accommodation: Individuals requiring sign language interpretation or other special accommodations should contact Ms. Johnson at least 15 days before the meeting. Authority: Sec. 222 of the Public Health Service Act (42 U.S.C. 217a) and sec. 10(a) VerDate jul<14>2003 16:42 May 26, 2005 Jkt 205001 of Pub. L. 92–463 (5 U.S.C. App. 2, sec. 10(a) and 41 CFR 102–3). (Catalog of Federal Domestic Assistance Program No. 93.733, Medicare—Hospital Insurance Program; and Program No. 93.774, Medicare—Supplementary Medical Insurance Program) Dated: May 18, 2005. Mark B. McClellan, Administrator, Centers for Medicare & Medicaid Services. [FR Doc. 05–10569 Filed 5–26–05; 8:45 am] BILLING CODE 4120–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [CMS–1293–N] Medicare Program; Public Meeting in Calendar Year 2005 for New Clinical Laboratory Tests Payment Determinations Centers for Medicare & Medicaid Services (CMS), HHS. ACTION: Notice. AGENCY: SUMMARY: This notice announces a public meeting to discuss payment determinations for specific new Physicians’ Current Procedural Terminology (CPT) codes for clinical laboratory tests. The meeting provides a forum for interested parties to make oral presentations and submit written comments on the new codes that will be included in Medicare’s Clinical Laboratory Fee Schedule for calendar year 2006, which will be effective on January 1, 2006. Discussion is directed toward technical issues relating to payment determinations for a specified list of new clinical laboratory codes. The development of the codes for clinical laboratory tests is largely performed by the CPT Editorial Panel and will not be further discussed at the CMS meeting. DATES: The public meeting is scheduled for Monday, July 18, 2005, from 10 a.m. to 4 p.m., e.d.t. ADDRESSES: The meeting will be held in the auditorium at the Centers for Medicare & Medicaid Services, located at 7500 Security Boulevard, Baltimore, Maryland 21244. FOR FURTHER INFORMATION CONTACT: Anita Greenberg, (410) 786–4601. SUPPLEMENTARY INFORMATION: I. Background Section 531(b) of the Medicare, Medicaid, and SCHIP Benefits Improvement and Protection Act of PO 00000 Frm 00060 Fmt 4703 Sfmt 4703 2000 (BIPA), Pub. L. 106–554, mandated procedures that permit public consultation for payment determinations for new clinical laboratory tests 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 International Classification of Diseases (ICD–9–CM). The procedures and public meeting announced in this notice for new clinical laboratory tests are in accordance with the procedures published on November 23, 2001, in the Federal Register (66 FR 58743) to implement section 531(b) of BIPA. Also, section 942(b) of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA), Pub. L. 108–173, amends section 1833(h)(8)(B)(iii) of the Act to require that we convene a public meeting to receive comments and recommendations (and data on which recommendations are based) for establishing payment amounts for new clinical laboratory tests. The public meeting is intended to provide expert input on the nature of new clinical laboratory tests and receive recommendations to either cross-walk or gap-fill for payment. Decisions regarding payment for the newly created Physicians’ Current Procedural Terminology (CPT) codes will not be made at this meeting. A summary of the new codes and the payment recommendations that are presented during the public meeting will be posted on our website by September 8, 2005 and can be accessed at https:// www.cms.hhs.gov/suppliers/clinlab. The summary will also display our tentative payment determinations, and interested parties may submit written comments on the tentative payment determinations by September 23, 2005, to the address specified in the summary. II. Registration Registration Procedures: Beginning June 20, 2005, registration may be completed on-line at https:// www.cms.hhs.gov/suppliers/clinlab. To register by telephone contact Anita Greenberg at (410) 786–4601. The following information must be submitted when registering: • Name; • Company name; • Address; • Telephone number(s); and • E-mail address(es). When registering, individuals who want to make a presentation must also specify which new clinical laboratory test code(s) they will be presenting. A confirmation will be sent upon receipt E:\FR\FM\27MYN1.SGM 27MYN1 Federal Register / Vol. 70, No. 102 / Friday, May 27, 2005 / Notices of the registration. Individuals may also register by calling Anita Greenberg at (410) 786–4601. Registration Deadline: Individuals must register by July 14, 2005. III. Presentations This meeting is open to the public. The on-site check-in for visitors will be held from 9:30 a.m. to 10 a.m., followed by opening remarks. Registered persons from the public may discuss and recommend payment determinations for specific new CPT codes for the 2005 Clinical Laboratory Fee Schedule. A newly created CPT code can either represent a refinement or modification of existing test methods, or a substantially new test method. The newly created CPT codes for the calendar year 2005 will be listed at the Web site https://www.cms.hhs.gov/ suppliers/clinlab on or after June 20, 2005. Oral presentations must be brief, and must be accompanied by three written copies. Presenters may also make copies available for approximately 50 meeting participants. Presenters should address the new test code(s) and descriptor, the test purpose and method, costs, charges, and a recommendation with rationale for one of two methods (cross-walking or gap-fill) for determining payment for new clinical laboratory codes. The first method, called crosswalking, a new test is determined 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. The second method, called gap-filling, is used when no comparable, existing test is available. When using this method, instructions are provided to each Medicare carrier to determine a payment amount for its geographic area(s) for use in the first year, and the carrier-specific amounts are used to establish a national limitation amount for following years. For each new clinical laboratory test code, a determination must be made to either cross-walk or to gap-fill, and, if cross-walking is appropriate, to know what tests to which to cross-walk. IV. Security, Building, and Parking Guidelines The meetings are held in a Federal government building; therefore, Federal security measures are applicable. In planning your arrival time, we recommend allowing additional time to clear security. In order to gain access to the building and grounds, participants must bring government-issued photo VerDate jul<14>2003 16:42 May 26, 2005 Jkt 205001 identification and a copy of your written meeting registration confirmation. Persons without proper identification may be denied access. Individuals who are not registered in advance will not be permitted to enter the building and will be unable to attend the meeting. The public may not enter the building earlier than 30 to 45 minutes prior to the convening of the meeting each day. Security measures also include inspection of vehicles, inside and out, at the entrance to the grounds. In addition, all persons entering the building must pass through a metal detector. All items brought to CMS, whether personal or for the purpose of demonstration or to support a presentation, are subject to inspection. We cannot assume responsibility for coordinating the receipt, transfer, transport, storage, setup, safety, or timely arrival of any personal belongings or items used for demonstration or to support a presentation. Parking permits and instructions are issued upon arrival by the guards at the main entrance. All visitors must be escorted in areas other than the lower and first-floor levels in the Central Building. V. Special Accommodations Individuals attending a meeting who are hearing or visually impaired and have special requirements, or a condition that requires special assistance or accommodations, must provide this information when registering for the meeting. Authority: Section 1102 and 1871 of the Social Security Act (42 U.S.C. 1302 and 42 U.S.C. 1395hh). Dated: May 12, 2005. Mark B. McClellan, Administrator, Centers for Medicare & Medicaid Services. [FR Doc. 05–10263– 5–26–05; 8:45 am] BILLING CODE 4120–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services Statement of Organization, Functions, and Delegations of Authority Part F of the Statement of Organization, Functions, and Delegations of Authority for the Department of Health and Human Services, Centers for Medicare & Medicaid Services (CMS), (Federal Register, Vol. 68, No. 34, pp. 8297– 8299, dated February 20, 2003) is PO 00000 Frm 00061 Fmt 4703 Sfmt 4703 30735 amended to reflect changes to the organizational structure of CMS. The changes include: (1) Renaming the Public Affairs Office to the Office of External Affairs, (2) restructuring the Center for Beneficiary Choices to implement Titles I and II of the Medicare Prescription Drug, Improvement and Modernization Act of 2003, (3) realigning functions of the Center for Medicaid and State Operations, (4) renaming the Office of Health Insurance Portability and Accountability Acts Standards to the Office of E-Health Standards and Services, and (5) establishing the Office of Acquisition and Grants Management. The specific amendments to Part F. are described below: • Section F.10. (Organization) is amended to read as follows: 1. Office of External Affairs (FAC). 2. Center for Beneficiary Choices (FAE). 3. Office of Legislation (FAF). 4. Center for Medicare Management (FAH). 5. Office of Equal Opportunity and Civil Rights (FAJ). 6. Office of Research, Development, and Information (FAK). 7. Office of Clinical Standards and Quality (FAM). 8. Office of the Actuary (FAN). 9. Center for Medicaid and State Operations (FAS). 10. Office of Operations Management (FAY). 11. Office of Information Services (FBB). 12. Office of Financial Management (FBC). 13. Office of Strategic Operations and Regulatory Affairs (FGA). 14. Office of E-Health Standards and Services (FHA). 15. Office of Acquisition and Grants Management (FKA). • Section F. 20. (Functions) is amended by deleting the functional statements in their entirety for the Public Affairs Office, the Center for Beneficiary Choices, the Office of Health Insurance Portability and Accountability Act Standards, and the Center for Medicaid and State Operations. The new functional statements for the Office of External Affairs, Center for Beneficiary Choices, Center for Medicaid and State Operations, Office of E-Health Standards and Services, and the Office of Acquisition and Grants Management read as follows: 1. Office of External Affairs (FAC) • Serves as the focal point for the Agency to the news media and provides leadership for the Agency in the area of E:\FR\FM\27MYN1.SGM 27MYN1

Agencies

[Federal Register Volume 70, Number 102 (Friday, May 27, 2005)]
[Notices]
[Pages 30734-30735]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-10263]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-1293-N]


Medicare Program; Public Meeting in Calendar Year 2005 for New 
Clinical Laboratory Tests Payment Determinations

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

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: This notice announces a public meeting to discuss payment 
determinations for specific new Physicians' Current Procedural 
Terminology (CPT) codes for clinical laboratory tests. The meeting 
provides a forum for interested parties to make oral presentations and 
submit written comments on the new codes that will be included in 
Medicare's Clinical Laboratory Fee Schedule for calendar year 2006, 
which will be effective on January 1, 2006. Discussion is directed 
toward technical issues relating to payment determinations for a 
specified list of new clinical laboratory codes. The development of the 
codes for clinical laboratory tests is largely performed by the CPT 
Editorial Panel and will not be further discussed at the CMS meeting.

DATES: The public meeting is scheduled for Monday, July 18, 2005, from 
10 a.m. to 4 p.m., e.d.t.

ADDRESSES: The meeting will be held in the auditorium at the Centers 
for Medicare & Medicaid Services, located at 7500 Security Boulevard, 
Baltimore, Maryland 21244.

FOR FURTHER INFORMATION CONTACT: Anita Greenberg, (410) 786-4601.

SUPPLEMENTARY INFORMATION:

I. Background

    Section 531(b) of the Medicare, Medicaid, and SCHIP Benefits 
Improvement and Protection Act of 2000 (BIPA), Pub. L. 106-554, 
mandated procedures that permit public consultation for payment 
determinations for new clinical laboratory tests 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 
International Classification of Diseases (ICD-9-CM). The procedures and 
public meeting announced in this notice for new clinical laboratory 
tests are in accordance with the procedures published on November 23, 
2001, in the Federal Register (66 FR 58743) to implement section 531(b) 
of BIPA. Also, section 942(b) of the Medicare Prescription Drug, 
Improvement, and Modernization Act of 2003 (MMA), Pub. L. 108-173, 
amends section 1833(h)(8)(B)(iii) of the Act to require that we convene 
a public meeting to receive comments and recommendations (and data on 
which recommendations are based) for establishing payment amounts for 
new clinical laboratory tests.
    The public meeting is intended to provide expert input on the 
nature of new clinical laboratory tests and receive recommendations to 
either cross-walk or gap-fill for payment. Decisions regarding payment 
for the newly created Physicians' Current Procedural Terminology (CPT) 
codes will not be made at this meeting. A summary of the new codes and 
the payment recommendations that are presented during the public 
meeting will be posted on our website by September 8, 2005 and can be 
accessed at https://www.cms.hhs.gov/suppliers/clinlab. The summary will 
also display our tentative payment determinations, and interested 
parties may submit written comments on the tentative payment 
determinations by September 23, 2005, to the address specified in the 
summary.

II. Registration

    Registration Procedures:
    Beginning June 20, 2005, registration may be completed on-line at 
https://www.cms.hhs.gov/suppliers/clinlab. To register by telephone 
contact Anita Greenberg at (410) 786-4601. The following information 
must be submitted when registering:
     Name;
     Company name;
     Address;
     Telephone number(s); and
     E-mail address(es).
    When registering, individuals who want to make a presentation must 
also specify which new clinical laboratory test code(s) they will be 
presenting. A confirmation will be sent upon receipt

[[Page 30735]]

of the registration. Individuals may also register by calling Anita 
Greenberg at (410) 786-4601. Registration Deadline: Individuals must 
register by July 14, 2005.

III. Presentations

    This meeting is open to the public. The on-site check-in for 
visitors will be held from 9:30 a.m. to 10 a.m., followed by opening 
remarks. Registered persons from the public may discuss and recommend 
payment determinations for specific new CPT codes for the 2005 Clinical 
Laboratory Fee Schedule. A newly created CPT code can either represent 
a refinement or modification of existing test methods, or a 
substantially new test method. The newly created CPT codes for the 
calendar year 2005 will be listed at the Web site https://
www.cms.hhs.gov/suppliers/clinlab on or after June 20, 2005.
    Oral presentations must be brief, and must be accompanied by three 
written copies.
    Presenters may also make copies available for approximately 50 
meeting participants. Presenters should address the new test code(s) 
and descriptor, the test purpose and method, costs, charges, and a 
recommendation with rationale for one of two methods (cross-walking or 
gap-fill) for determining payment for new clinical laboratory codes.
    The first method, called cross-walking, a new test is determined 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. The second method, called gap-filling, is used when 
no comparable, existing test is available. When using this method, 
instructions are provided to each Medicare carrier to determine a 
payment amount for its geographic area(s) for use in the first year, 
and the carrier-specific amounts are used to establish a national 
limitation amount for following years. For each new clinical laboratory 
test code, a determination must be made to either cross-walk or to gap-
fill, and, if cross-walking is appropriate, to know what tests to which 
to cross-walk.

IV. Security, Building, and Parking Guidelines

    The meetings are held in a Federal government building; therefore, 
Federal security measures are applicable. In planning your arrival 
time, we recommend allowing additional time to clear security. In order 
to gain access to the building and grounds, participants must bring 
government-issued photo identification and a copy of your written 
meeting registration confirmation. Persons without proper 
identification may be denied access.
    Individuals who are not registered in advance will not be permitted 
to enter the building and will be unable to attend the meeting. The 
public may not enter the building earlier than 30 to 45 minutes prior 
to the convening of the meeting each day.
    Security measures also include inspection of vehicles, inside and 
out, at the entrance to the grounds. In addition, all persons entering 
the building must pass through a metal detector. All items brought to 
CMS, whether personal or for the purpose of demonstration or to support 
a presentation, are subject to inspection. We cannot assume 
responsibility for coordinating the receipt, transfer, transport, 
storage, set-up, safety, or timely arrival of any personal belongings 
or items used for demonstration or to support a presentation.
    Parking permits and instructions are issued upon arrival by the 
guards at the main entrance.
    All visitors must be escorted in areas other than the lower and 
first-floor levels in the Central Building.

V. Special Accommodations

    Individuals attending a meeting who are hearing or visually 
impaired and have special requirements, or a condition that requires 
special assistance or accommodations, must provide this information 
when registering for the meeting.

    Authority: Section 1102 and 1871 of the Social Security Act (42 
U.S.C. 1302 and 42 U.S.C. 1395hh).

    Dated: May 12, 2005.
Mark B. McClellan,
Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 05-10263- 5-26-05; 8:45 am]
BILLING CODE 4120-01-P
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