E9-4124. Medicare Program; Public Meetings in Calendar Year 2009 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 2009 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 2009 HCPCS public meeting dates:

1. Tuesday, April 28, 2009, 9 a.m. to 5 p.m., eastern daylight time (e.d.t.) (Drugs/Biologicals/Radiopharmaceuticals/Radiologic Imaging Agents).

2. Wednesday, April 29, 2009, 9 a.m. to 5 p.m., e.d.t. (Drugs/Biologicals/Radiopharmaceuticals/Radiologic Imaging Agents).

3. Tuesday, May 12, 2009, 9 a.m. to 5 p.m., e.d.t. (Supplies and Other).

4. Wednesday, May 13, 2009, 9 a.m. to 5 p.m., e.d.t. (Supplies and Other).

5. Wednesday, May 27, 2009, 9 a.m. to 5 p.m., e.d.t. (Orthotics and Prosthetics).

6. Thursday, May 28, 2009, 9 a.m. to 5 p.m., e.d.t. (Durable Medical Equipment (DME) and Accessories).

7. Thursday, July 9, 2009, 9 a.m. to 5 p.m., e.d.t. (Durable Medical Equipment (DME) and Accessories, including Negative Pressure Wound Therapy (NPWT) devices.

Deadlines for Primary Speaker Registration and Presentation Materials: The deadline for registering to be a primary speaker, and submitting materials and writings that will be used in support of an oral presentation are as follows:

• April 14, 2009 for the April 28 and 29, 2009 public meetings.
• April 28, 2009 for the May 12 and 13, 2009 public meetings.
• May 13, 2009 for the May 27 and 28, 2009 public meetings.
• June 25, 2009 for the July 9, 2009 public meeting.

Deadlines for All Other Attendees Registration: All individuals must register for each date that they plan on attending. The registration deadlines are different for each meeting. Registration deadlines are as follows:

• April 21, 2009 for the April 28 and 29, 2009 public meeting dates.
• May 5, 2009 for the May 12 and 13, 2009 public meeting dates.
• May 20, 2009 for the May 27 and 28, 2009 public meetings.
• July 2, 2009 for the July 9, 2009 public meeting.

Deadlines for Requesting Special Accommodations:

• April 14, 2009 for the April 28 and 29, 2009 public meeting dates.
• April 28, 2009 for the May 12 and 13, 2009 public meeting dates.
• May 13, 2009 for the May 27 and 28, 2009 public meetings.
• June 25, 2009 for the July 9, 2009 public meeting.

Deadline for Submission of Written Comments: Written comments must be received by the date of meeting at which a request is scheduled for discussion.

ADDRESSES:

Meeting Location: The public meetings will be held in the main auditorium of the central building of the Centers for Medicare and Medicaid Services, 7500 Security Boulevard, Baltimore, MD 21244-1850.

Submission of Written Comments: Written comments can be e-mailed to [e-mail] or sent via regular mail to Jennifer Carver or Gloria Knight, HCPCS Public Meeting Coordinator, Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Mail Stop C5-08-27, Baltimore, MD 21244.

Registration and Special Accommodations: Individuals wishing to participate or who need special accommodations or both must register by completing the on-line registration located at http://www.cms.hhs.gov/​medhcpcsgeninfo or by contacting one of the following persons: Jennifer Carver at [phone] or [e-mail]; or Gloria Knight at [phone] or [e-mail].

FOR FURTHER INFORMATION CONTACT:

Jennifer Carver at [phone] or [e-mail]; or Gloria Knight at [phone] or [e-mail].

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 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.

In the November 23, 2001 Federal Register (66 FR 58743), we published a notice 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. Therefore, we are implementing a 10-page submission limit and firm deadlines for receipt of any presentation materials the meeting participant wishes CMS to consider for this reason, our HCPCS Public Meeting Coordinators will only accept and review presentation materials received by the deadline for each public meeting, as specified in the DATES section of this notice.

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.

II. Meeting Registration

A. Required Information for Registration

The following information must be provided when registering:

• Name;
• Company name and address;
• Direct-dial 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.

B. Registration Process

1. 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. 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 submissions for each public meeting as specified in the DATES section of this notice. The sum of all materials including the 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 complete publication as soon as possible.

These materials may be delivered by regular mail postmark date no later than deadline date or by e-mail to one of the HCPCS Public Meeting Coordinators as specified in the ADDRESSES section of this notice. Individuals will need to provide 35 copies if materials are delivered by mail.

2. 5-Minute Speakers

To afford the same opportunity to all attendees, 5-minute speakers are not required to register as primary speakers; however, 5-minute speakers must still register as attendees by the deadline set forth under “Deadlines for all Other Attendees Registration” in the DATES section of this notice. 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 they will address.

C. Additional Meeting/Registration Information

Public Meetings are scheduled far in advance of the influx of HCPCS applications each cycle. At the time they are scheduled we can only anticipate the number of applications that we receive in each category. As a result, we may not need the second day of Drugs/Biologicals/Radiopharmaceuticals/Radiologic Imaging Agents Public Meeting (Wednesday, April 29, 2009). We have scheduled this date tentatively. The Public Meeting Agendas published on CMS' HCPCS Web site at http://www.cms.hhs.gov/​medhcpcsgeninfo will serve as final notification regarding whether a meeting will be held on April 29, 2009.

The product category reported by the applicant may not be the same as that assigned by CMS. Prior to registering to attend a public meeting, all participants are advised to review the public meeting agendas at http://www.cms.hhs.gov/​medhcpcsgeninfo which identify 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 4 weeks before each meeting.

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 4 weeks before the first meeting date on the HCPCS Web site at 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 HCPCS Web site 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.

The HCPCS Web site also contains a document titled “HCPCS Decision Tree & Definitions” which illustrates, in flow diagram format, HCPCS coding standards as described in our Coding Procedures document. A summary of each public meeting will be posted on the HCPCS Web site by the end of August 2009.

III. 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 that will register for each meeting. Meeting participants should arrive early to allow time to clear security and sign-in. Each meeting is expected to begin promptly as scheduled. 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 one of the HCPCS Public Meeting Coordinators.

These materials may be delivered by regular mail (postmark date no later than deadline date) or by e-mail to one of the HCPCS Public Meeting Coordinators specified in the ADDRESSES section. 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.

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 4 weeks before the first public meeting in 2009 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 “Meeting Registration” section of this notice and contact one of the HCPCS Public Meeting Coordinators, specified in the ADDRESSES section. Primary speakers must also separately register as primary speakers by the date specified in the DATES section of this notice.

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.

Each primary speaker and 5-minute speaker must declare in their presentation at the meeting, as well as in their written summary, whether they have any financial involvement with the manufacturers or competitors of any items 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

(1) Written comments will be accepted from the general public and meeting registrants anytime up to the date of the public meeting at which a request is discussed. Comments must be sent to the address listed in the ADDRESSES section of this notice.

(2) Meeting attendees may also submit their written comments at the meeting.

(3) 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.

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 will be denied access.

To ensure that foreign visitors have appropriate access to Department facilities, HHS has established a policy regarding HHS employees hosting foreign nationals to clear such visits with the appropriate security officials. Attendees that are Foreign Nationals (reside outside the U.S.) need to identify themselves as such, and provide the following information for security clearance to the public meeting coordinator by the registration date:

• Visitor's full name (as it appears on passport);
• Gender;
• Country of origin and citizenship;
• Biographical data and related information;
• Date of birth;
• Place of birth;
• Passport number;
• Passport issue date;
• Passport expiration date; and
• Dates of visits.

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 45 minutes before the convening of the meeting each day.

Security measures will also include inspection of vehicles, inside and outside, at the entrance to the grounds and buildings. In addition, all persons entering the building must pass through a metal detector. All items brought to CMS 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. Special arrangements and approvals are required in order to bring pieces of equipment or medical devices at least 2 weeks prior to each public meeting. These arrangements need to be made with the public meeting coordinator. It is possible that certain requests made in advance of the public meeting could be denied because of unique safety, security or handling issues related to the equipment. A minimum of 2 weeks is required for approvals and security procedures. Any request not submitted at least 2 weeks in advance of the public meeting will be denied.

Parking permits and instructions are issued upon arrival by the guards at the main entrance.

All visitors must be escorted by agency staff in order to enter areas other than the public areas on the lower and first-floor levels in the Central Building.

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

Dated: February 20, 2009.

Charlene Frizzera,

Acting Adminstrator, Centers for Medicare & Medicaid Services.