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, 8969-8972 [E9-4124]

Download as PDF Federal Register / Vol. 74, No. 38 / Friday, February 27, 2009 / Notices + Surveyor performance evaluation systems; and + Conflict of interest policies relating to individuals in the survey and accreditation decision process. • Descriptions of the organization’s— + Data management and analysis system; + Policies and procedures for investigating and responding to complaints against accredited organizations; and+ Types and categories of accreditation offered and PDP sponsors and MA organizations currently accredited within those types and categories. In accordance with § 423.171(b) of our regulations, the applicant must provide documentation relating to the following: • Its ability to provide data in a CMS compatible format. • The adequacy of personnel and other resources necessary to perform the required surveys and other activities. • Assurances that it will comply with ongoing responsibility requirements specified in § 423.168(c) of our regulations. Additionally, the accrediting organization must provide CMS with the opportunity to observe its accreditation process on site at a managed care organization and must provide any other information that CMS requires to prepare for an onsite visit. These site visits will help to verify that the information presented in the application is correct and to make a determination on the application. In accordance with section 1865(a)(3)(A) of the Act and our regulations at § 423.168(b)(1), this proposed notice solicits public comment on the ability of URAC’s accreditation program to meet or exceed the Medicare requirements for PDP sponsors which it seeks authority to deem as being in compliance with such requirements. In accordance with § 423.168(b)(1)(iii), comments are due [at least 30] days after the date of publication of this proposed notice. rwilkins on PROD1PC63 with NOTICES2 III. Collection of Information Requirements This document does not impose information collection and recordkeeping requirements. Consequently, it need not be reviewed by the Office of Management and Budget under the authority of the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35). IV. Response to Comments Because of the large number of public comments we normally receive on Federal Register documents, we are not able to acknowledge or respond to them VerDate Nov<24>2008 16:39 Feb 26, 2009 Jkt 217001 individually. We will consider all comments we receive by the date and time specified in the DATES section of this preamble, and, when we proceed with a subsequent document, we will respond to the comments in the preamble to that document. V. Regulatory Impact Statement In accordance with the provisions of Executive Order 12866, this regulation was not reviewed by the Office of Management and Budget. (Catalog of Federal Domestic Assistance Program No. 93.773, Medicare—Hospital Insurance Program; and No. 93.774, Medicare—Supplementary Medical Insurance Program) Dated: February 13, 2009. Charlene Frizzera, Acting Administrator, Centers for Medicare & Medicaid Services. [FR Doc. E9–4320 Filed 2–26–09; 8:45 am] BILLING CODE 4120–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [CMS–1497–N] 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). PO 00000 Frm 00074 Fmt 4703 Sfmt 4703 8969 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. E:\FR\FM\27FEN1.SGM 27FEN1 8970 Federal Register / Vol. 74, No. 38 / Friday, February 27, 2009 / Notices Submission of Written Comments: Written comments can be e-mailed to HCPCS@cms.hhs.gov 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 https://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 Gloria Knight at (410) 786–4598 or Gloria.Knight@cms.hhs.gov. FOR FURTHER INFORMATION CONTACT: Jennifer Carver at (410) 786–6610 or Jennifer.Carver@cms.hhs.gov; or Gloria Knight at (410) 786–4598 or Gloria.Knight@cms.hhs.gov. SUPPLEMENTARY INFORMATION: rwilkins on PROD1PC63 with NOTICES2 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 VerDate Nov<24>2008 16:39 Feb 26, 2009 Jkt 217001 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 PO 00000 Frm 00075 Fmt 4703 Sfmt 4703 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 https://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 https://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 https://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 https:// 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 E:\FR\FM\27FEN1.SGM 27FEN1 Federal Register / Vol. 74, No. 38 / Friday, February 27, 2009 / Notices 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. 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. 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. 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. rwilkins on PROD1PC63 with NOTICES2 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 VerDate Nov<24>2008 16:39 Feb 26, 2009 Jkt 217001 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 PO 00000 Frm 00076 Fmt 4703 Sfmt 4703 8971 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 E:\FR\FM\27FEN1.SGM 27FEN1 8972 Federal Register / Vol. 74, No. 38 / Friday, February 27, 2009 / Notices 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. [FR Doc. E9–4124 Filed 2–26–09; 8:45 am] BILLING CODE 4120–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health rwilkins on PROD1PC63 with NOTICES2 Proposed Collection: Comment Request; Revision of OMB No. 0925– 0002, Exp. 9/30/11, ‘‘Ruth L. Kirschstein NRSA Individual Fellowship Application and Related Forms’’ SUMMARY: In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the Office of Extramural Research, the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval. Proposed Collection: Title: Ruth L. Kirschstein NRSA Individual Fellowship Application and Related Forms. Type of Information Collection Request: Revision, OMB 0925–0002, Expiration Date 9/30/11. Form Numbers: PHS 416–1, 416–9, 416–5, 416–7, 6031, 6031–1. Need and Use of Information Collection: The PHS 416–1and 416–9 are used by individuals to apply for direct research training support. Awards are made to individual applicants for specified training proposals in biomedical and behavioral research, selected as a result of a national competition. The other related forms (PHS 416–5, 416–7, 6031, 6031–1) are used by these individuals to activate, terminate, and provide for payback of a National Research Service Award. Frequency of response: Applicants may submit applications for published receipt dates. If awarded, annual progress is reported and trainees may be appointed or reappointed. Affected Public: Individuals or households; businesses or other for profit; not-forprofit institutions; Federal Government; and State, Local or Tribal Governments. Type of Respondents: Adult scientific trainees and Respondents: 34,454; Estimated Number of Responses per VerDate Nov<24>2008 16:39 Feb 26, 2009 Jkt 217001 Respondent: 1; Average Burden Hours Per Response: 3.9; and Estimated Total Annual Burden Hours Requested: 132,501. The annualized cost to respondents is estimated at: $4,637,535. There are no Capital Costs to report. There are no Operating or Maintenance Costs to report. Request for Comments: Written comments and/or suggestions from the public and affected agencies are invited on one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) the accuracy of the agency’s estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. For Further Information Contact: To request more information on the proposed project or to obtain a copy of the data collection plans and instruments, contact Ms. Mikia Currie, Project Clearance Branch, Office of Policy for Extramural Research Administration, NIH, Rockledge 1 Building, Room 3505, 6705 Rockledge Drive, Bethesda, MD 20892–7974, or call non-toll-free number 301–435– 0941, or e-mail your request, including your address to: [curriem@od.nih.gov]. Comments Due Date: Comments regarding this information collection are best assured of having their full effect if received within 60-days of the date of this publication. Dated: February 20, 2009. George Gardner, Assistant Grants Policy Officer, OPERA, OER, National Institutes of Health. [FR Doc. E9–4209 Filed 2–26–09; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center for Scientific Review; Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of the following meetings. PO 00000 Frm 00077 Fmt 4703 Sfmt 4703 The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: Center for Scientific Review Special Emphasis Panel, Special Review of Cognition, Language and Perception Fellowships. Date: March 2, 2009. Time: 1 p.m. to 2 p.m. Agenda: To review and evaluate grant applications. Place: The Fairmont Washington, DC, 2401 M Street, NW., Washington, DC 20037. Contact Person: Dana Jeffrey Plude, PhD, Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3176, MSC 7848, Bethesda, MD 20892, 301–435– 2309, pluded@csr.nih.gov. This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. Name of Committee: Center for Scientific Review Special Emphasis Panel, Mechanisms of Tumor Initiation and Progression. Date: March 16, 2009. Time: 8:30 a.m. to 10:30 a.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892. (Telephone Conference Call). Contact Person: Elaine Sierra-Rivera, PhD, Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 6184, MSC 7804, Bethesda, MD 20892, 301–435– 1779, riverase@csr.nih.gov. This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. Name of Committee: Center for Scientific Review Special Emphasis Panel, Small Business: Psychopathology and Adult Disorders. Date: March 17, 2009. Time: 8 a.m. to 6 p.m. Agenda: To review and evaluate grant applications. Place: Bahia Resort Hotel, 998 W. Mission Bay Drive, San Diego, CA 92109. Contact Person: Dana Jeffrey Plude, PhD, Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3176, MSC 7848, Bethesda, MD 20892, 301–435– 2309, pluded@csr.nih.gov. This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. E:\FR\FM\27FEN1.SGM 27FEN1

Agencies

[Federal Register Volume 74, Number 38 (Friday, February 27, 2009)]
[Notices]
[Pages 8969-8972]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-4124]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-1497-N]


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.

[[Page 8970]]

    Submission of Written Comments: Written comments can be e-mailed to 
HCPCS@cms.hhs.gov 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 https://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 Gloria 
Knight at (410) 786-4598 or Gloria.Knight@cms.hhs.gov.

FOR FURTHER INFORMATION CONTACT: Jennifer Carver at (410) 786-6610 or 
Jennifer.Carver@cms.hhs.gov; or Gloria Knight at (410) 786-4598 or 
Gloria.Knight@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 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 https://
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 https://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 https://
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 https://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

[[Page 8971]]

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

[[Page 8972]]

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.
[FR Doc. E9-4124 Filed 2-26-09; 8:45 am]
BILLING CODE 4120-01-P
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