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 

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. 

mstockstill on DSK4VPTVN1PROD with NOTICES

Federal Register / Vol. 78, No. 32 / Friday, February 15, 2013 / Notices 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. 

mstockstill on DSK4VPTVN1PROD with NOTICES

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. 

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 

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. 

SUMMARY: 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 

mstockstill on DSK4VPTVN1PROD with NOTICES