# 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 *http://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 *http://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 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 *http://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.