Medicare Program; Public Meetings in Calendar Year 2013 for All New Public Requests for Revisions to the Healthcare Common Procedure Coding System (HCPCS) Coding and Payment Determinations, 11202-11204 [2013-03479]

Download as PDF 11202 Federal Register / Vol. 78, No. 32 / Friday, February 15, 2013 / Notices DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [CMS–1438–N] Medicare Program; Public Meetings in Calendar Year 2013 for All New Public Requests for Revisions to the Healthcare Common Procedure Coding System (HCPCS) Coding and Payment Determinations Centers for Medicare & Medicaid Services (CMS), HHS. ACTION: Notice. AGENCY: This notice announces the dates, time, and location of the Healthcare Common Procedure Coding System (HCPCS) public meetings to be held in calendar year 2013 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. The discussion will be focused on responses to our specific preliminary recommendations and will include all items on the public meeting agenda. DATES: Meeting Dates: The following are the 2013 HCPCS public meeting dates: 1. Wednesday, May 8, 2013, 9 a.m. to 5 p.m., eastern daylight time (e.d.t.) (Drugs/Biologicals/ Radiopharmaceuticals/Radiologic Imaging Agents). 2. Thursday, May 9, 2013, 9 a.m. to 5 p.m., e.d.t. (Drugs/Biologicals/ Radiopharmaceuticals/Radiologic Imaging Agents). 3. Wednesday, May 29, 2013, 9 a.m. to 5 p.m., e.d.t. (Supplies and Other). 4. Tuesday, June 4, 2013, 9 a.m. to 5 p.m., e.d.t. (Durable Medical Equipment (DME) and Accessories & (Orthotics and Prosthetics)). 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 24, 2013 for the May 8, 2013 and May 9, 2013 public meetings. • May 15, 2013 for the May 29, 2013 public meeting. • May 22, 2013 for the June 4, 2013 public meeting. Deadline for Attendees that are Foreign Nationals Registration: Attendees that are foreign nationals (as described in section IV. of this notice) mstockstill on DSK4VPTVN1PROD with NOTICES SUMMARY: VerDate Mar<15>2010 19:09 Feb 14, 2013 Jkt 229001 are required to identify themselves as such, and provide the necessary information for security clearance (as described in section IV. of this notice) to the public meeting coordinator at least 12 business days in advance of the date of the public meeting date the individual plans to attend. Therefore, the deadlines for attendees that are foreign nationals are as follows: • April 22, 2013 for the May 8, 2013 and May 9, 2013 public meetings. • May 10, 2013 for the May 29, 2013 public meeting. • May 16, 2013 for the June 4, 2013 public meeting. Deadlines for all Other Attendees Registration: All other individuals who plan to enter the building to attend the public meeting must register for each date that they plan on attending. The registration deadlines are different for each meeting. Registration deadlines are as follows: • May 1, 2013 for the May 8, 2013 and May 9, 2013 public meeting dates. • May 22, 2013 for the May 29, 2013 public meeting date. • May 29, 2013 for the June 4, 2013 public meeting date. Deadlines for Requesting Special Accommodations: Individuals who plan to attend the public meetings and require sign-language interpretation or other special assistance must request these services by the following deadlines: • April 24, 2013 for the May 8, 2013 and May 9, 2013 public meetings. • May 15, 2013 for the May 29, 2013 public meeting. • May 22, 2013 for the June 4, 2013 public meeting. Deadline for Submission of Written Comments: Written comments must be received by the date of the meeting at which the code 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 may either be emailed to HCPCS@cms.hhs.gov or sent via regular mail to Jennifer Carver or Kimberlee Combs Miller, HCPCS Public Meeting Coordinator, Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Mail Stop C5–08– 27, Baltimore, MD 21244–1850. Registration and Special Accommodations: Individuals wishing to participate or who need special accommodations or both must register by completing the on-line registration PO 00000 Frm 00070 Fmt 4703 Sfmt 4703 located at www.cms.hhs.gov/ medhcpcsgeninfo or by contacting one of the following persons: Jennifer Carver at (410) 786–6610 or Jennifer.Carver@cms.hhs.gov; or Kimberlee Combs Miller at (410) 786– 6707 or Kimberlee.CombsMiller@cms.hhs.gov. FOR FURTHER INFORMATION CONTACT: Jennifer Carver at (410) 786–6610 or Jennifer.Carver@cms.hhs.gov. Kimberlee Combs Miller at (410) 786–6707 or Kimberlee.CombsMiller@cms.hhs.gov. 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 Healthcare Common Procedure Coding System (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 a meeting speaker wishes us 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:\FR\FM\15FEN1.SGM 15FEN1 Federal Register / Vol. 78, No. 32 / Friday, February 15, 2013 / Notices • Email address. • Special needs information. C. Additional Meeting/Registration Information A CMS staff member will confirm your registration by email. 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. This exception applies only to the page limit and not the submission deadline. The materials may be emailed or delivered by regular mail to one of the HCPCS Public Meeting Coordinators as specified in the ADDRESSES section of this notice. The materials must be emailed or postmarked no later than the deadline specified in the DATES section of this notice. Individuals will need to provide 35 copies if materials are delivered by mail. mstockstill on DSK4VPTVN1PROD with NOTICES 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. Individuals 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. VerDate Mar<15>2010 19:09 Feb 14, 2013 Jkt 229001 We were able this year to combine the Orthotics/Prosthetics and DME meeting into one public meeting date. That public meeting will be Tuesday, June 4, 2013. The product category reported by the applicant may not be the same as that assigned by us. Prior to registering to attend a public meeting, all participants are advised to review the public meeting agendas at 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 our preliminary decision will be posted on our HCPCS Web site at 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 official HCPCS Web site at www.cms.hhs.gov/medhcpcsgeninfo. The document titled ‘‘Guidelines for Participation in Public Meetings for All New Public Requests for Revisions to the Healthcare Common Procedure Coding System (HCPCS)’’ will be made available on the HCPCS Web site at least 4 weeks before the first public meeting in 2013 for all new public requests for revisions to the HCPCS. Individuals who intend to provide a presentation at a public meeting will need to familiarize themselves with the HCPCS Web site and the valuable information it provides to prospective registrants. The HCPCS Web site also contains a document titled ‘‘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 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 a 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 2013. 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 PO 00000 Frm 00071 Fmt 4703 Sfmt 4703 11203 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 All primary speakers 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. The materials may be emailed or delivered by regular mail to one of the HCPCS Public Meeting Coordinators as specified in the ADDRESSES section of this notice. The materials must be emailed or postmarked no later than the deadline specified in the DATES section of this notice. 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. 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. E:\FR\FM\15FEN1.SGM 15FEN1 11204 Federal Register / Vol. 78, No. 32 / Friday, February 15, 2013 / Notices 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 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. Meeting attendees may also submit their written comments at the meeting. 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. mstockstill on DSK4VPTVN1PROD with NOTICES IV. Security, Building, and Parking Guidelines The meetings are held within the CMS Complex which is not open to the general public. Visitors to the complex are required to show a valid U.S. Government issued photo identification, preferably a driver’s license, at the time of entry. Participants will also be subject to a vehicular search before access to the complex is granted. Participants not in possession of a valid identification or who are in possession of prohibited items will be denied access to the complex. Prohibited items on Federal property include but are not limited to, alcoholic beverages, illegal narcotics, explosives, firearms or other dangerous weapons (including pocket knives), dogs or other animals except service animals. Once cleared for entry to the complex participants will be directed to parking by a security officer. In order to ensure expedited entry into the building it is recommended that participants have their ID and a copy of their written meeting registration confirmation readily available and that they do not bring laptops or large/bulky items into the building. Participants are VerDate Mar<15>2010 19:09 Feb 14, 2013 Jkt 229001 reminded that photography on the CMS complex is prohibited. CMS has also been declared a tobacco free campus and violators are subject to legal action. In planning arrival time, we recommend allowing additional time to clear security. 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. Guest access to the complex is limited to the meeting area, the main lobby, and the cafeteria. If a visitor is found outside of those areas without proper escort they may be escorted out of the facility. Also be mindful that there will be an opportunity for everyone to speak and we request that everyone waits for the appropriate time to present their product or opinions. Disruptive behavior will not be tolerated and may result in removal from the meetings and escort from the complex. No visitor is allowed to attach USB cables, thumb drives or any other equipment to any CMS information technology (IT) system or hardware for any purpose at anytime. Additionally, CMS staff is prohibited from taking such actions on behalf of a visitor or utilizing any removable media provided by a visitor. 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 at least 2 weeks prior to each public meeting in order to bring pieces of equipment or medical devices. 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. CMS policy requires that every foreign national (as defined by the Department of Homeland Security is ‘‘an individual who is a citizen of any country other than the United States’’) is assigned a host (in accordance with the Department Foreign Visitor Management Policy, Appendix C, Guidelines for Hosts and Escorts). The host/hosting official is required to inform the Division of Critical Infrastructure Protection (DCIP) at least 12 business days in advance of any visit PO 00000 Frm 00072 Fmt 4703 Sfmt 4703 by a foreign national. Foreign nationals will be required to produce a valid passport at the time of entry. Attendees that are foreign nationals need to identify themselves as such, and provide the following information for security clearance to the public meeting coordinator by the date specified in the DATES section of this notice: • 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. • Dates of visits. • Company Name. • Position/Title. Dated: February 8, 2013. Marilyn Tavenner, Acting Administrator, Centers for Medicare & Medicaid Services. [FR Doc. 2013–03479 Filed 2–14–13; 8:45 am] BILLING CODE 4120–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2013–D–0145] Accreditation and Reaccreditation Process for Firms Under the Third Party Review Program: Part I; Draft Guidance for Industry, Food and Drug Administration Staff, and Third Party Reviewers; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ‘‘Accreditation and Reaccreditation Process for Firms Under the Third Party Review Program: Part I.’’ The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Food and Drug Administration Safety and Innovation Act (FDASIA), requires FDA to establish and publish criteria to reaccredit or deny reaccreditation to persons accredited by FDA under the FD&C Act to perform premarket review of medical devices. This draft guidance describes the accreditation, reaccreditation, and accreditation withdrawal processes, including criteria that will be considered to accredit, reaccredit, deny accreditation to, and deny reaccreditation to third party SUMMARY: E:\FR\FM\15FEN1.SGM 15FEN1

Agencies

[Federal Register Volume 78, Number 32 (Friday, February 15, 2013)]
[Notices]
[Pages 11202-11204]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-03479]



[[Page 11202]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-1438-N]


Medicare Program; Public Meetings in Calendar Year 2013 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 2013 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. The discussion will be 
focused on responses to our specific preliminary recommendations and 
will include all items on the public meeting agenda.

DATES: Meeting Dates: The following are the 2013 HCPCS public meeting 
dates:
    1. Wednesday, May 8, 2013, 9 a.m. to 5 p.m., eastern daylight time 
(e.d.t.) (Drugs/Biologicals/Radiopharmaceuticals/Radiologic Imaging 
Agents).
    2. Thursday, May 9, 2013, 9 a.m. to 5 p.m., e.d.t. (Drugs/
Biologicals/Radiopharmaceuticals/Radiologic Imaging Agents).
    3. Wednesday, May 29, 2013, 9 a.m. to 5 p.m., e.d.t. (Supplies and 
Other).
    4. Tuesday, June 4, 2013, 9 a.m. to 5 p.m., e.d.t. (Durable Medical 
Equipment (DME) and Accessories & (Orthotics and Prosthetics)).
    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 24, 2013 for the May 8, 2013 and May 9, 2013 public 
meetings.
     May 15, 2013 for the May 29, 2013 public meeting.
     May 22, 2013 for the June 4, 2013 public meeting.
    Deadline for Attendees that are Foreign Nationals Registration: 
Attendees that are foreign nationals (as described in section IV. of 
this notice) are required to identify themselves as such, and provide 
the necessary information for security clearance (as described in 
section IV. of this notice) to the public meeting coordinator at least 
12 business days in advance of the date of the public meeting date the 
individual plans to attend. Therefore, the deadlines for attendees that 
are foreign nationals are as follows:
     April 22, 2013 for the May 8, 2013 and May 9, 2013 public 
meetings.
     May 10, 2013 for the May 29, 2013 public meeting.
     May 16, 2013 for the June 4, 2013 public meeting.
    Deadlines for all Other Attendees Registration: All other 
individuals who plan to enter the building to attend the public meeting 
must register for each date that they plan on attending. The 
registration deadlines are different for each meeting. Registration 
deadlines are as follows:
     May 1, 2013 for the May 8, 2013 and May 9, 2013 public 
meeting dates.
     May 22, 2013 for the May 29, 2013 public meeting date.
     May 29, 2013 for the June 4, 2013 public meeting date.
    Deadlines for Requesting Special Accommodations: Individuals who 
plan to attend the public meetings and require sign-language 
interpretation or other special assistance must request these services 
by the following deadlines:
     April 24, 2013 for the May 8, 2013 and May 9, 2013 public 
meetings.
     May 15, 2013 for the May 29, 2013 public meeting.
     May 22, 2013 for the June 4, 2013 public meeting.
    Deadline for Submission of Written Comments: Written comments must 
be received by the date of the meeting at which the code 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 may either be 
emailed to HCPCS@cms.hhs.gov or sent via regular mail to Jennifer 
Carver or Kimberlee Combs Miller, HCPCS Public Meeting Coordinator, 
Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Mail 
Stop C5-08-27, Baltimore, MD 21244-1850.
    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 www.cms.hhs.gov/medhcpcsgeninfo or by contacting one of the following persons: Jennifer 
Carver at (410) 786-6610 or Jennifer.Carver@cms.hhs.gov; or Kimberlee 
Combs Miller at (410) 786-6707 or Kimberlee.CombsMiller@cms.hhs.gov.

FOR FURTHER INFORMATION CONTACT: Jennifer Carver at (410) 786-6610 or 
Jennifer.Carver@cms.hhs.gov. Kimberlee Combs Miller at (410) 786-6707 
or Kimberlee.CombsMiller@cms.hhs.gov.

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 Healthcare Common Procedure Coding 
System (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 a meeting speaker wishes us 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.

[[Page 11203]]

     Email address.
     Special needs information.

A CMS staff member will confirm your registration by email.

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. This exception 
applies only to the page limit and not the submission deadline.
    The materials may be emailed or delivered by regular mail to one of 
the HCPCS Public Meeting Coordinators as specified in the ADDRESSES 
section of this notice. The materials must be emailed or postmarked no 
later than the deadline specified in the DATES 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. Individuals 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

    We were able this year to combine the Orthotics/Prosthetics and DME 
meeting into one public meeting date. That public meeting will be 
Tuesday, June 4, 2013.
    The product category reported by the applicant may not be the same 
as that assigned by us. Prior to registering to attend a public 
meeting, all participants are advised to review the public meeting 
agendas at 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 our preliminary 
decision will be posted on our HCPCS Web site at 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 official 
HCPCS Web site at www.cms.hhs.gov/medhcpcsgeninfo. The document titled 
``Guidelines for Participation in Public Meetings for All New Public 
Requests for Revisions to the Healthcare Common Procedure Coding System 
(HCPCS)'' will be made available on the HCPCS Web site at least 4 weeks 
before the first public meeting in 2013 for all new public requests for 
revisions to the HCPCS. Individuals who intend to provide a 
presentation at a public meeting will need to familiarize themselves 
with the HCPCS Web site and the valuable information it provides to 
prospective registrants. The HCPCS Web site also contains a document 
titled ``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 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 a 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 2013.

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

    All primary speakers 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.
    The materials may be emailed or delivered by regular mail to one of 
the HCPCS Public Meeting Coordinators as specified in the ADDRESSES 
section of this notice. The materials must be emailed or postmarked no 
later than the deadline specified in the DATES section of this notice. 
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.
    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.

[[Page 11204]]

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

    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.
    Meeting attendees may also submit their written comments at the 
meeting. 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 within the CMS Complex which is not open to 
the general public. Visitors to the complex are required to show a 
valid U.S. Government issued photo identification, preferably a 
driver's license, at the time of entry. Participants will also be 
subject to a vehicular search before access to the complex is granted. 
Participants not in possession of a valid identification or who are in 
possession of prohibited items will be denied access to the complex. 
Prohibited items on Federal property include but are not limited to, 
alcoholic beverages, illegal narcotics, explosives, firearms or other 
dangerous weapons (including pocket knives), dogs or other animals 
except service animals. Once cleared for entry to the complex 
participants will be directed to parking by a security officer.
    In order to ensure expedited entry into the building it is 
recommended that participants have their ID and a copy of their written 
meeting registration confirmation readily available and that they do 
not bring laptops or large/bulky items into the building. Participants 
are reminded that photography on the CMS complex is prohibited. CMS has 
also been declared a tobacco free campus and violators are subject to 
legal action. In planning arrival time, we recommend allowing 
additional time to clear security. 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.
    Guest access to the complex is limited to the meeting area, the 
main lobby, and the cafeteria. If a visitor is found outside of those 
areas without proper escort they may be escorted out of the facility. 
Also be mindful that there will be an opportunity for everyone to speak 
and we request that everyone waits for the appropriate time to present 
their product or opinions. Disruptive behavior will not be tolerated 
and may result in removal from the meetings and escort from the 
complex. No visitor is allowed to attach USB cables, thumb drives or 
any other equipment to any CMS information technology (IT) system or 
hardware for any purpose at anytime. Additionally, CMS staff is 
prohibited from taking such actions on behalf of a visitor or utilizing 
any removable media provided by a visitor.
    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 at least 
2 weeks prior to each public meeting in order to bring pieces of 
equipment or medical devices. 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.
    CMS policy requires that every foreign national (as defined by the 
Department of Homeland Security is ``an individual who is a citizen of 
any country other than the United States'') is assigned a host (in 
accordance with the Department Foreign Visitor Management Policy, 
Appendix C, Guidelines for Hosts and Escorts). The host/hosting 
official is required to inform the Division of Critical Infrastructure 
Protection (DCIP) at least 12 business days in advance of any visit by 
a foreign national. Foreign nationals will be required to produce a 
valid passport at the time of entry.
    Attendees that are foreign nationals need to identify themselves as 
such, and provide the following information for security clearance to 
the public meeting coordinator by the date specified in the DATES 
section of this notice:
     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.
     Dates of visits.
     Company Name.
     Position/Title.

    Dated: February 8, 2013.
Marilyn Tavenner,
Acting Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2013-03479 Filed 2-14-13; 8:45 am]
BILLING CODE 4120-01-P