Federal Register / Vol. 77, No. 227 / Monday, November 26, 2012 / Notices 70447 

exceeded the Medicare conditions for 

coverage for ASCs. We received no 

public comments in response to our 

proposed notice. 

IV. Provisions of the Final Notice 

A. Differences Between AAAASF’s 

Standards and Requirements for 

Accreditation and Medicare’s 

Conditions and Survey Requirements 

We compared AAAASF’s ASC 

requirements and survey process with 

the Medicare conditions for coverage 

and survey process as outlined in the 

State Operations Manual (SOM). Our 

review and evaluation of AAAASF’s 

ASC application, which were conducted 

as described in section III of this final 

notice, yielded the following: 

• To meet the requirements at 

§ 416.41(b)(2), AAAASF revised its 

standards to ensure the ASC’s transfer 

agreement is with a local, Medicareparticipating hospital that meets the 

requirements for emergency services. 

• To meet the requirements at 

§ 416.44(a)(2), AAAASF revised its 

standards to address the requirement 

that ‘‘the ASC must have a separate 

recovery room and waiting area.’’ 

• AAAASF revised its crosswalk to 

ensure that all regulatory references are 

correct for the following citations: 

§ 416.42(a)(2), § 416.42(c)(2), 

§ 416.44(c)(3), § 416.50(c)(1), § 416.50(e), 

and § 416.50(g). 

• To meet the requirements at 

§ 488.4(a)(4), AAAASF modified its 

policies to ensure all personnel files are 

accurate and complete. 

• To meet the requirements at 

§ 488.4(a)(5), AAAASF modified its 

policies to improve the accuracy and 

consistency of data submissions to CMS. 

• To meet the requirements at 

§ 488.4(a)(6), AAAASF modified its 

policies to ensure all compliant 

investigations are conducted in 

accordance with the requirements in 

chapter Five of the SOM. 

• To meet the requirements at 

§ 488.6(a), AAAASF revised its policies 

and procedures to ensure deemed status 

survey files are complete and accurate. 

• To meet the requirements at 

§ 488.12, AAAASF modified its policies 

to ensure all pertinent survey 

information, including all surveys 

conducted, is included in the final 

accreditation decision letters. 

• To meet the medical record 

requirements at Appendix L of the 

SOM, AAAASF revised its policies to 

ensure surveyors review the required 

number of medical records during a 

survey. 

• To meet the requirements at Section 

2728 of the SOM, AAAASF modified its 

policies regarding timeframes for 

sending and receiving a plan of 

correction. 

• To meet the requirements at Section 

3012 of the SOM, AAAASF modified its 

policies to ensure follow-up, focused 

surveys for condition level 

noncompliance are conducted timely. 

• To meet the requirements at Section 

2700A of the SOM, AAAASF modified 

its policies to ensure all surveys are 

conducted unannounced. 

B. Term of Approval 

Based on our review and observations 

described in section III of this final 

notice, we have determined that 

AAAASF’s requirements for ASCs meet 

or exceed our requirements. Therefore, 

we approve AAAASF as a national 

accreditation organization for ASCs that 

request participation in the Medicare 

program, effective November 27, 2012 

through November 27, 2018. 

V. Collection of Information 

Requirements 

This document does not impose any 

information reporting, recordkeeping or 

third-party disclosure 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. 35). 

Authority: Section 1865 of the Social 

Security Act (42 U.S.C. 1395bb). 

(Catalog of Federal Domestic Assistance 

Program No. 93.778, Medical Assistance 

Program; No. 93.773 Medicare—ASC 

Insurance Program; and No. 93.774, 

Medicare—Supplementary Medical 

Insurance Program) 

Dated: November 20, 2012. 

Marilyn Tavenner, 

Acting Administrator, Centers for Medicare 

& Medicaid Services. 

[FR Doc. 2012–28640 Filed 11–23–12; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–1597–N] 

Medicare Program; Semi-Annual 

Meeting of the Advisory Panel on 

Hospital Outpatient Payment (HOP 

Panel)—March 11 and 12, 2013 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Notice. 

SUMMARY: This notice announces the 

first semi-annual meeting of the 

Advisory Panel on Hospital Outpatient 

Payment (HOP, the Panel), (the 

Ambulatory Payment Classification 

(APC) Panel) for 2013. The purpose of 

the Panel is to advise the Secretary of 

the Department of Health and Human 

Services (DHHS) (the Secretary) and the 

Administrator of the Centers for 

Medicare & Medicaid Services (CMS) 

(the Administrator) on the clinical 

integrity of the APC groups and their 

associated weights, and hospital 

outpatient therapeutic supervision 

issues. 

DATES: Meeting Date: The first semiannual meeting in 2013 is scheduled for 

the following dates and times. 

Note: The times listed in this notice are 

Eastern Daylight Time (EDT) and are 

approximate times; consequently, the 

meetings may last longer than the times 

listed in this notice, but will not begin before 

the posted times: 

• Monday, March 11, 2013, 1 p.m. to 5 

p.m. EDT 

• Tuesday, March 12, 2013, 9 a.m. to 5 

p.m. EDT 

Deadlines 

Deadline for Presentations and 

Comments 

The email copy of a presentation or 

comment and form CMS–20017 must be 

in the Designated Federal Official’s 

(DFO’s) email inbox 

(APCPanel@cms.hhs.gov) by 5 p.m. 

EDT, Friday, January 25, 2013. The 

hardcopy of the presentation must be 

received by the DFO on or before 

Friday, February 1, 2013. Presentations 

and comments that are not received by 

the due dates will be considered late 

and will not be included on the agenda. 

(See below for submission instructions 

for both hardcopy and electronic 

submissions.) 

Meeting Registration Timeframe: 

Monday, January 9, 2013 through 

Friday, February 22, 2013 at 5 p.m. EDT. 

Participants planning to attend this 

meeting in person must register online, 

during the above specified timeframe at: 

https://www.cms.gov/apps/events/

default.asp. On this Web page, double 

click the ‘‘Upcoming Events’’ hyperlink, 

and then double click the ‘‘HOP Panel’’ 

event title link and enter the required 

information. Include any requests for 

special accommodations. Note: 

Participants who do not plan to attend 

this meeting in person should not 

register. No registration is required for 

participants that plan to view the 

meeting via webcast. 

mstockstill on DSK4VPTVN1PROD with NOTICES

70448 Federal Register / Vol. 77, No. 227 / Monday, November 26, 2012 / Notices 

Submission Instructions for 

Presentations and Comments 

Because of staffing and resource 

limitations, we cannot accept written 

comments and or presentations by FAX. 

Presentations 

Presentation subject matter must be 

within the scope of the Panel designated 

in the Charter. Any presentations 

outside of the scope of this Panel will 

be returned and/or amendments 

requested. Unrelated topics include, but 

are not limited to, the conversion factor, 

charge compression, revisions to the 

cost report, pass-through payments, 

correct coding, new technology 

applications (including supporting 

information/documentation), provider 

payment adjustments, supervision of 

hospital outpatient diagnostic services 

and the types of practitioners that are 

permitted to supervise hospital 

outpatient services. The Panel may not 

recommend that services be designated 

as nonsurgical extended duration 

therapeutic services. 

All presentations are limited to 5 

minutes total presentation time, 

regardless of the number of individuals 

or organizations represented by a single 

presentation. Presenters may use their 5 

minutes to represent either one or more 

agenda items. 

All presentations will be considered 

public information and may be posted 

on the CMS Web site and will be shared 

with the public. Presenters should not 

send pictures of patients or Medicare 

beneficiaries in any of the documents 

(unless their faces have been blocked 

out) or include any examples with 

personally identifiable information. 

In order to consider presentation and/ 

or comment requests, we will need to 

receive the following information: 

1. A hardcopy of your presentation; 

only hardcopy comments and 

presentations can be reproduced for 

public dissemination. 

2. An email copy of your presentation 

sent to the DFO mailbox, APCPanel@

cms.hhs.gov. 

3. Form CMS–20017 with complete 

contact information that includes name, 

address, phone, and email addresses for 

all presenters and a contact that can 

answer any questions and or provide 

revisions that are requested for the 

presentation. 

Æ Presenters must clearly explain the 

action(s) that they are requesting CMS to 

take in the appropriate section of the 

form. A presenter’s relationship to the 

organization that they represent must 

also be clearly listed. 

Æ The form is now available through 

the CMS Forms Web site. The Uniform 

Resource Locator (URL) for linking to 

this form is as follows: http://www.cms.

hhs.gov/cmsforms/downloads/

cms20017.pdf. 

Meeting Location and Webcast: The 

meeting will be held in the Auditorium, 

CMS Central Office, 7500 Security 

Boulevard, Woodlawn, Maryland 

21244–1850. 

Alternately, the public may view this 

meeting via a webcast. During the 

scheduled meeting, webcasting is 

accessible online at: http://cms.gov/live 

or http://www.ustream.tv. Viewers 

interested in receiving the webcast from 

http://www.ustream.tv will need to type 

‘‘CMS Public Events’’ in the search bar 

to access the webcast. 

FOR FURTHER INFORMATION CONTACT: For 

inquiries about the Panel, contact the 

DFO: Chuck Braver, 7500 Security 

Boulevard, Mail Stop: C4–05–17, 

Woodlawn, MD 21244–1850. Phone: 

(410) 786–3985. Email: APCPanel@cms.

hhs.gov 

Mail hardcopies and email copies to 

the following addresses: Chuck Braver, 

DFO, CMS, CM, HAPG, DOC—HOP 

Panel, 7500 Security Blvd. Mail Stop: 

C4–05–17, Woodlawn, MD 21244–1850 

Email: APCPanel@cms.hhs.gov 

Note: We recommend that you advise 

couriers of the following information: When 

delivering hardcopies of presentations to 

CMS, call (410) 786–4532 or (410) 786–6719 

to ensure receipt of documents by 

appropriate staff. 

News Media: Representatives must 

contact our Public Affairs Office at (202) 

690–6145. 

Advisory Committees’ Information 

Lines: The phone numbers for the CMS 

Federal Advisory Committee Hotline are 

1–877–449–5659 (toll free) and (410) 

786–3985 (local). 

Web Sites: For additional information 

on the Panel and updates to the Panel’s 

activities, we refer readers to view our 

Web site at the following: http://www.

cms.gov/Regulations-and-Guidance/

Guidance/FACA/AdvisoryPanelon

AmbulatoryPaymentClassification

Groups.html. 

You may also search information 

about the Panel and its membership in 

the Federal Advisory Committee Act 

(FACA) database at the following URL: 

https://www.fido.gov/facadatabase/

public.asp. 

SUPPLEMENTARY INFORMATION: 

I. Background 

The Secretary is required by section 

1833(t)(9)(A) of the Social Security Act 

(the Act) and section 222 of the Public 

Health Service Act (PHS Act) to consult 

with an expert outside advisory panel 

regarding the clinical integrity of the 

Ambulatory Payment Classification 

(APC) groups and relative payment 

weights. The Panel (which was formerly 

known as the Advisory Panel on 

Ambulatory Payment Classification 

Groups) is governed by the provisions of 

the Federal Advisory Committee Act 

(Pub. L. 92–463), as amended (5 U.S.C. 

Appendix 2), to set forth standards for 

the formation and use of advisory 

panels. 

The Charter provides that the Panel 

shall meet up to 3 times annually. We 

consider the technical advice provided 

by the Panel as we prepare the proposed 

and final rules to update the outpatient 

prospective payment system (OPPS). 

II. Agenda 

The agenda for the March 2013 

meeting will provide for discussion and 

comment on the following topics as 

designated in the Panel’s Charter: 

• Addressing whether procedures 

within an APC group are similar both 

clinically and in terms of resource use. 

• Evaluating APC group weights. 

• Reviewing the packaging of OPPS 

services and costs, including the 

methodology and the impact on APC 

groups and payment. 

• Removing procedures from the 

inpatient list for payment under the 

OPPS. 

• Using single and multiple 

procedure claims data for CMS’ 

determination of APC group weights. 

• Addressing other technical issues 

concerning APC group structure. 

• Recommending the appropriate 

supervision level (general, direct, or 

personal) for individual hospital 

outpatient therapeutic services. 

The subject matter before the Panel 

will be limited to these and related 

topics. Unrelated topics include, but are 

not limited to, the conversion factor, 

charge compression, revisions to the 

cost report, pass-through payments, 

correct coding, new technology 

applications (including supporting 

information/documentation), provider 

payment adjustments, hospital 

outpatient supervision of diagnostic 

services and the types of practitioners 

who are permitted to supervise hospital 

outpatient services. 

The Panel may not recommend that 

services be designated as nonsurgical 

extended duration therapeutic services. 

The Panel may use data collected or 

developed by entities and organizations, 

other than the DHHS and CMS in 

conducting its review. We recommend 

organizations submit data for the Panel’s 

and CMS staff’s review. The Agenda 

will be posted on the CMS Web site 

before the meeting. 

mstockstill on DSK4VPTVN1PROD with NOTICES

Federal Register / Vol. 77, No. 227 / Monday, November 26, 2012 / Notices 70449 

III. Oral Comments 

In addition to formal oral 

presentations, which are limited to 5 

minutes total per presentation, there 

will be an opportunity during the 

meeting for public oral comments, 

which will be limited to 1 minute for 

each individual and a total of 3 minutes 

per organization. 

IV. Meeting Attendance 

The meeting is open to the public; 

however, attendance is limited to space 

available. Priority will be given to those 

who pre-register, and attendance may be 

limited based on the number of 

registrants and the space available. 

Persons wishing to attend this 

meeting, which is located on Federal 

property, must register by following the 

instructions in the ‘‘Meeting 

Registration Timeframe’’ section of this 

notice. A confirmation email will be 

sent to the registrants shortly after 

completing the registration process. 

V. Security, Building, and Parking 

Guidelines 

The following are the security, 

building, and parking guidelines: 

• Persons attending the meeting, 

including presenters, must be preregistered and on the attendance list by 

the prescribed date. 

• Individuals who are not preregistered in advance may not be 

permitted to enter the building and may 

be unable to attend the meeting. 

• Attendees must present valid photo 

identification to the Federal Protective 

Service or Guard Service personnel 

before entering the building. Without a 

current, valid photo ID, persons may not 

be permitted entry to the building. 

• Security measures include 

inspection of vehicles, inside and out, at 

the entrance to the grounds. 

• All persons entering the building 

must pass through a metal detector. 

• All items brought into CMS 

including personal items, for example, 

laptops and cell phones are subject to 

physical inspection. 

• The public may enter the building 

30 to 45 minutes before the meeting 

convenes each day. 

• All visitors must be escorted in 

areas other than the lower and first-floor 

levels in the Central Building. 

• The main-entrance guards will 

issue parking permits and instructions 

upon arrival at the building. 

VI. Special Accommodations 

Individuals requiring sign-language 

interpretation or other special 

accommodations must include the 

request for these services during 

registration. 

VII. Panel Recommendations and 

Discussions 

The Panel’s recommendations at any 

Panel meeting generally are not final 

until they have been reviewed and 

approved by the Panel on the last day 

of the meeting, before the final 

adjournment. These recommendations 

will be posted to our Web site after the 

meeting. 

VIII. 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. 35). 

(Catalog of Federal Domestic Assistance 

Program; No. 93.773 Medicare—Hospital 

Insurance Program; and No. 93.774, 

Medicare—Supplementary Medical 

Insurance Program) 

Dated: November 14, 2012. 

Marilyn Tavenner, 

Acting Administrator, Centers for Medicare 

& Medicaid Services. 

[FR Doc. 2012–28639 Filed 11–23–12; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2012–N–1021] 

Medical Device User Fee and 

Modernization Act; Notice to Public of 

Web Site Location of Fiscal Year 2013 

Proposed Guidance Development 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

Web site location where the Agency will 

post two lists of guidance documents 

that the Center for Devices and 

Radiological Health (CDRH) is intending 

to publish in Fiscal Year (FY) 2013. In 

addition, FDA has established a docket 

where stakeholders may provide 

comments and/or propose draft 

language for those topics, suggest new 

or different guidance documents, and 

comment on the priority of topics for 

guidance. 

DATES: Submit either electronic or 

written comments at any time. 

ADDRESSES: Submit electronic 

comments on the proposed guidance to 

http://www.regulations.gov. Submit 

written comments to the Division of 

Dockets Management (HFA–305), Food 

and Drug Administration, 5630 Fishers 

Lane, rm. 1061, Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Philip Desjardins, Center for Devices 

and Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, rm. 5452, Silver Spring, 

MD 20993–0002, 301–796–5678. 

SUPPLEMENTARY INFORMATION: 

I. Background 

During negotiations over the Medical 

Device User Fee Amendments of 2012 

(MDUFA III), Title II, Food and Drug 

Administration Safety and Innovation 

Act (Pub. L. 112–114), FDA agreed, in 

return for additional funding from 

industry, to meet a variety of 

quantitative and qualitative goals 

intended to help get safe and effective 

medical devices to market more quickly. 

These commitments include annually 

posting a list of prioritized medical 

device guidance documents that the 

Agency intends to publish within 12 

months of the date this list is published 

each fiscal year (the ‘‘A-list’’) and a list 

of device guidance documents that the 

Agency intends to publish, as the 

Agency’s guidance-development 

resources permit each fiscal year (the 

‘‘B-list’’). In addition to posting lists of 

prioritized device guidance documents, 

FDA has committed to updating its Web 

site in a timely manner to reflect the 

Agency’s review of previously 

published guidance documents, 

including the deletion of guidance 

documents that no longer represent the 

Agency’s interpretation of, or policy on, 

a regulatory issue, and notation of 

guidance documents that are under 

review by the Agency. Fulfillment of 

this commitment will be reflected 

through the issuance of updated 

guidance on existing topics, removal of 

guidances that that no longer reflect 

FDA’s current thinking on a particular 

topic, and annual updates to A-list and 

B-list announced in this notice. 

This notice announces the Web site 

location of the two lists of guidance 

documents which CDRH is intending to 

publish during FY 2013. We note that 

the Agency is not required to publish 

every guidance on either list if the 

resources needed would be to the 

detriment of meeting quantitative 

review timelines and statutory 

obligations. The Agency is not 

precluded from issuing guidance 

documents that are not on either list. 

FDA and CDRH priorities are subject 

to change at any time. Topics on this 

and past guidance priority lists may be 

removed or modified based on current 

mstockstill on DSK4VPTVN1PROD with NOTICES