06-2566. Medicare Program; Public Meetings in Calendar Year 2006 for All New Public Requests for Revisions to the Healthcare Common Procedure Coding System (HCPCS) Coding and Payment Determinations

AGENCY:

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

ACTION:

Notice.

SUMMARY:

This notice announces the dates, time, and location of the Healthcare Common Procedure Coding System (HCPCS) public meetings to be held in calendar year 2006 to discuss our preliminary coding and payment determinations for all new public requests for revisions to the HCPCS.

These meetings provide a forum for interested parties to make oral presentations or to submit written comments in response to preliminary coding and payment determinations. Discussion will be directed toward responses to our specific preliminary recommendations and will include all items on the public meeting agenda.

DATES:

Meeting Dates: The following are the 2006 HCPCS public meeting dates:

1. Tuesday, April 25, 2006, 9 a.m. to 5 p.m., e.d.s.t. (Durable Medical Equipment (DME) and Accessories).

2. Wednesday, April 26, 2006, 9 a.m. to 5 p.m., e.d.s.t. (Orthotics and Prosthetics).

3. Thursday, April 27, 2006, 9 a.m. to 12 p.m., e.d.s.t. (Orthotics and Prosthetics).

4. Thursday, May 4, 2006, 9 a.m. to 5 p.m., e.d.s.t. (Supplies and Other).

5. Friday, May 5, 2006, 9 a.m. to 5 p.m., e.d.s.t. (Supplies and Other).

6. Thursday, May 11, 2006, 9 a.m. to 5 p.m., e.d.s.t. (Drugs/Biologicals/Radiopharmaceuticals/Radiologic Imaging Agents).

7. Friday, May 12, 2006, 9 a.m. to 5 p.m., e.d.s.t. (Drugs/Biologicals/Radiopharmaceuticals/Radiologic Imaging Agents).

The product category reported by the meeting participant may not be the same as that assigned by CMS. All meeting participants are advised to review the public meeting agenda at http://www.cms.hhs.gov/​medhcpcsgeninfo which identifies our category determinations, and the dates each item will be discussed. Draft agendas, including a summary of each request and CMS' preliminary decision will be posted on our HCPCS Web site at http://www.cms.hhs.gov/​medhcpcsgeninfo at least one month before each meeting.

Each meeting day will begin at 9 a.m. and end at 5 p.m., e.d.s.t., except for Thursday, April 27, 2006, the meeting will begin at 9 a.m. and end at 12 p.m., e.d.s.t.

ADDRESSES:

The public meetings will be held in the auditorium at the Centers for Medicare and Medicaid Services, 7500 Security Boulevard, Baltimore, Maryland 21244.

Meeting Registration

Registration Procedures: Registration can be completed online at http://www.cms.hhs.gov/​medhcpcsgeninfo. To register by telephone or e-mail, for the April 25, April 26, and April 27, 2006 meetings, contact Felicia Eggleston at [e-mail] or telephone [phone]; or Trish Brooks at [e-mail] or telephone [phone].

For the May 4, May 5, May 11, and May 12, 2006 meetings, contact Jennifer Carver at [e-mail] or telephone [phone]; or Gloria Knight at [e-mail] or telephone [phone].

The following information must be provided when registering: Name, company name and address, telephone and fax numbers, e-mail address, and special needs information. A CMS staff member will confirm your registration by mail, e-mail, or fax.

Registration Deadlines: Individuals must register for each date they plan either to attend or to provide a presentation. For the April 25, 26, and 27 public meeting dates, the deadline for registration is April 18, 2006; for the May 4 and 5, 2006 public meeting, the deadline for registration is April 27, 2006; for the May 11 and 12 public meetings, the deadline for registration is May 4, 2006.

Primary Speakers: Individuals must also indicate whether they are the “primary speaker” for an agenda item. Primary speakers must be designated by the entity that submitted the HCPCS coding request. When registering, primary speakers must provide a brief written statement regarding the nature of the information they intend to provide, and advise the HCPCS Public Meeting Coordinator regarding needs for audio/visual support. In order to avoid disruption of the meeting and ensure compatibility with our systems, tapes and disk files are tested and arranged in speaker sequence well in advance of the meeting. We will accept tapes and disk files that are received by the deadline for each public meeting, as listed in section I-A titled “Oral Presentation Procedures.” The sum of all materials including presentation may not exceed 10 pages (each side of a page counts as 1 page). An exception will be made to the 10-page limit for relevant studies published between the application deadline and the public meeting date, in which case, we would like a copy of the entire study as published as soon as possible.

These materials may be delivered by regular mail (postmark date no later than deadline date) or by e-mail to the respective HCPCS Public Meeting Coordinators listed under the section titled “Meeting Registration.” Individuals will need to provide 35 copies if materials are delivered by mail.

5-Minute Speakers: In order to afford the same opportunity to all attendees, there is no pre-registration for 5-minute speakers. Attendees can sign up only on the day of the meeting to do a 5-minute presentation. They must provide their name, company name and address, contact information as specified on the sign-up sheet, and identify the specific agenda item that will be addressed.

Web Site: Additional details regarding the public meeting process for all new public requests for revisions to the HCPCS, along with information on how to register and guidelines for an effective presentation, will be posted at least 1 month before the first meeting date on the HCPCS Web site: http://www.cms.hhs.gov/​medhcpcsgeninfo. Individuals who intend to provide a presentation at a public meeting need to familiarize themselves with the HCPCS Web site and the valuable information it provides to prospective registrants. The same URL, the HCPCS Web site, also contains a document titled “The Healthcare Common Procedure Coding System (HCPCS) Level II Coding Procedures,” which is a description of the HCPCS coding process, including a detailed explanation of the procedures used to make coding and payment determinations for all the products, supplies, and services that are coded in the HCPCS. A summary of each public meeting will be posted on the HCPCS Web site by the end of August 2006.

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(b) of BIPA mandated that we establish procedures that permit public consultation for coding and payment determinations for new durable medical equipment (DME) under Medicare Part B of title XVIII of the Social Security Act (the Act). The procedures and public meetings announced in this notice for new DME are in response to the mandate of section 531(b) of BIPA.

We published a notice in the November 23, 2001 Federal Register (66 FR 58743) providing information regarding the establishment of the public meeting process for DME. It is our intent to distribute any materials submitted to CMS to the HCPCS workgroup members for their consideration. CMS and the HCPCS workgroup members require sufficient preparation time to review all relevant materials. For this reason, our HCPCS Public Meeting Coordinators will only accept and review presentation materials received by the deadline for each public meeting, as listed in section I-A titled “Oral Presentation Procedures.” Therefore, we are implementing a 10-page submission limit and firm deadlines for receipt of any materials and presentations the meeting participant wishes CMS to consider.

The public meeting process provides an opportunity for the public to become aware of coding changes under consideration, as well as an opportunity for CMS to gather public input.

I. Presentations and Comment Format

We can only estimate the amount of meeting time that will be needed since it is difficult to anticipate the total number of speakers for each meeting. Meeting participants should arrive early since each meeting is anticipated to begin promptly at 9 a.m. Speakers need to arrive prepared and wait until it is their turn to speak. Meetings may end earlier than the stated ending time.

A. Oral Presentation Procedures

Individuals who are planning to provide an oral presentation must register as provided under the section titled “Meeting Registration.” Materials and writings that will be used in support of an oral presentation should be submitted to the HCPCS Public Meeting Coordinators as listed under the section titled “Meeting Registration.”

The deadline for submitting materials and writings that will be used in support of an oral presentation are as follows: For the April 25, 26, and 27, 2006 public meetings, the deadline is April 11, 2006; for the May 4 and 5, 2006 public meetings, the deadline is April 20, 2006; for the May 11 and 12, 2006 meetings, the deadline is April 26, 2006. These materials may be delivered by regular mail (postmark date no later than deadline date) or by e-mail to the respective HCPCS Public Meeting Coordinators listed in the section titled “Meeting Registration.” Individuals will need to include 35 copies if materials are delivered by mail.

B. Primary Speaker Presentations

The individual or entity requesting revisions to the HCPCS coding system for a particular agenda item may designate one “primary speaker” to make a presentation for a maximum of 15 minutes. Fifteen minutes is the total time interval for the presentation, and the presentation must incorporate the demonstration, set-up, and distribution of material. In establishing the public meeting agenda, we may group multiple, related requests under the same agenda item. In that case, we will decide whether additional time will be allotted, and may opt to increase the amount of time allotted to the speaker by increments of less than 15 minutes. In other words, the amount of time allotted to aggregate proposals might not be expanded exponentially by the number of requests.

We will post “Guidelines for Participation in Public Meetings for All New Public Requests for Revisions to the Healthcare Common Procedure Coding System (HCPCS) Coding and Payment Determinations” on the official HCPCS Web site at least a month before the first public meeting in 2006 for all new public requests for revisions to the HCPCS. Individuals designated to be the primary speaker must register to attend the meeting using the registration procedures described under the section titled “Meeting Registration” and, at least 15 days before the meeting, contact the appropriate HCPCS Public Meeting Coordinators, listed under the section titled “Meeting Registration.”

C. “5-Minute” Speaker Presentations

Meeting attendees can sign up at the meeting, on a first-come, first-served basis, to make 5-minute presentations on individual agenda items. Based on the number of items on the agenda and the progress of the meeting, a determination will be made at the meeting by the meeting coordinator and the meeting moderator regarding how many 5-minute speakers can be accommodated.

D. Speaker Declaration

On the day of the meeting, before the end of the meeting, all primary speakers and 5-minute speakers must provide a brief written summary of their comments and conclusions to the HCPCS Public Meeting Coordinator.

The primary speakers and the 5-minute speakers must declare in their presentations at the meeting, as well as in their written summaries, whether they have any financial involvement with the manufacturers or competitors of any items or services being discussed; this includes any payment, salary, remuneration, or benefit provided to that speaker by the manufacturer or the manufacturer's representatives.

E. Written Comments From Meeting Attendees

Written comments are welcome from all persons in attendance at a public meeting, regardless of whether they make an oral presentation. Written comments can be submitted either at the meeting or before the meeting via e-mail to http://www.cms.hhs.gov/​medhcpcsgeninfo or via regular mail to the HCPCS Public Meeting Coordinator, Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Mail Stop C5-08-27, Baltimore, MD 21244. Written comments to this address are also accepted from the general public anytime up to the date of the public meeting at which a request is discussed. Due to the close timing of the public meetings, subsequent workgroup reconsiderations, and final decisions, we are able to consider only those comments received in writing by the close of the public meeting at which the request is discussed.

II. 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 before the convening of the meeting each day.

Security measures will 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.

III. 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: Sections 1102 and 1871 of the Social Security Act (42 U.S.C. 1302 and 42 U.S.C. 139hh).

Dated: March 10, 2006.

Mark B. McClellan,

Administrator, Centers for Medicare & Medicaid Services.