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have to provide a short statement about 

why they are electing to implement an 

unreasonable rate increase. This 

statement would be entered into a data 

entry text box in the Rate Review Data 

Collection System and would not need 

to be more than a paragraph or two in 

length. There is no form or instructions 

associated with this statement apart 

from the requirements provided in the 

regulation. 

The Final Justification Statement will 

be posted on an HHS Web site in the 

same location as the Preliminary 

Justification and Rate Review Final 

Determination. Additionally, health 

insurance issuers implementing rate 

increases that were determined to be 

unreasonable, must post all of this 

information—the Preliminary 

Justification, the Rate Review Final 

Determination, and the Final 

Justification Statement on their Web 

sites for a period of 3 years. 

In addition to the aforementioned 

requirements, we revised the 

information collection request as a 

result of an amendment to the 

regulation discussed in the final rule 

that published September 6, 2011 (76 

FR 54969). The amendment to the rate 

review final rule updated the 

applicability of the rate review 

requirements to include products that 

would be considered part of the 

individual or small group market had 

they not been sold through associations, 

including those that are consider to be 

large group products under State law or 

have been otherwise excluded from 

State’s existing definitions for 

individual and small group products. 

This change resulted in an increase in 

the total number of rate increases that 

are subject to the rate review reporting 

requirements. The amendment did not 

propose any changes to the information 

that issuers must submit for each rate 

increase. Thus, burden associated with 

each rate increase submission remains 

unchanged from the final rate review 

rule. The revised association product 

reporting requirements took effect on 

November 1, 2011. CMS received a 6 

month Emergency PRA approval for the 

revised association reporting 

requirements on October 31, 2011 

(OMB–0938–1141). CMS is now 

requesting a 3-year OMB approval of 

these collection requirements. Form 

Number: CMS–10379 (OCN: 0938– 

1141); Frequency: Annually; Affected 

Public: Private Sector and States; 

Number of Respondents: 452; Number 

of Responses: 3,571; Total Annual 

Hours: 14,630. (For policy questions 

regarding this collection, contact Sally 

McCarty at (301) 492–4489. For all other 

issues call (410) 786–1326.) 

4. Type of Information Collection 

Request: New information collection; 

Title of Information Collection: Medical 

Loss Ratio Annual Reporting and Rebate 

Calculation; Use: Under Section 2718 of 

the Affordable Care Act and 

implementing regulations at 45 CFR Part 

158 (75 FR 74864, December 1, 2010 

(Interim Final Rule); 75 FR 82277, 

December 30, 2010 (Technical 

Correction); and 76 FR 76574, December 

7, 2011 (Final Rule with comment 

period)), a health insurance issuer 

(issuer) offering group or individual 

health insurance coverage must submit 

a report to the Secretary concerning the 

amount the issuer spends each year on 

claims, quality improvement expenses, 

non-claims costs, Federal and State 

taxes and licensing and regulatory fees, 

and the amount of earned premium. An 

issuer must provide an annual rebate to 

enrollees if the amount it spends on 

certain costs compared to its premium 

revenue (excluding Federal and States 

taxes and licensing and regulatory fees) 

does not meet a certain ratio, referred to 

as the medical loss ratio (MLR). An 

interim final rule (IFR) implementing 

the MLR was published on December 1, 

2010 (75 FR 74865) and modified by 

technical corrections on December 30, 

2010 (75 FR 82277), which added Part 

158 to Title 45 of the Code of Federal 

Regulations. The IFR is effective January 

1, 2011. A final rule regarding selected 

provisions of the interim final rule was 

published on December 7, 2011 (76 FR 

76574) and an interim final rule 

regarding an issue not included in 

issuers’ reporting requirements 

(distribution of rebates by non-federal 

governmental plans) was also published 

on December 7, 2011 (76 FR 76596). 

Each issuer is required to submit MLR 

data annually, including information 

about any rebates it must provide, on a 

form prescribed by CMS for each large 

group market, small group market, and 

individual market within each State in 

which the issuer conducts business. 

Data is to be submitted electronically 

through CMS’ Health Insurance 

Oversight System (HIOS). Additionally, 

each issuer is required to maintain for 

a period of seven years all documents, 

records and other evidence that support 

the data included in each issuer’s 

annual report to the Secretary. Form 

Number: CMS–10418; Frequency: 

Annually; Affected Public: Private 

Sector: Business or other for-profits and 

not-for-profit institutions; Number of 

Respondents: 527; Number of 

Responses: 5,530; Total Annual Hours: 

352,563. (For policy questions regarding 

this collection, contact Carol Jimenez at 

(301) 492–4457. For all other issues, call 

(410) 786–1326.) 

To obtain copies of the supporting 

statement and any related forms for the 

proposed paperwork collections 

referenced above, access CMS’ Web Site 

address at http://www.cms.hhs.gov/ 

PaperworkReductionActof1995, or 

Email your request, including your 

address, phone number, OMB number, 

and CMS document identifier, to 

Paperwork@cms.hhs.gov, or call the 

Reports Clearance Office on (410) 786– 

1326. 

In commenting on the proposed 

information collections please reference 

the document identifier or OMB control 

number. To be assured consideration, 

comments and recommendations must 

be submitted in one of the following 

ways by February 14, 2012: 

1. Electronically. You may submit 

your comments electronically to http:// 

www.regulations.gov. Follow the 

instructions for ‘‘Comment or 

Submission’’ or ‘‘More Search Options’’ 

to find the information collection 

document(s) accepting comments. 

2. By regular mail. You may mail 

written comments to the following 

address: CMS, Office of Strategic 

Operations and Regulatory Affairs, 

Division of Regulations Development, 

Attention: Document Identifier/OMB 

Control Number llll, Room C4–26– 

05, 7500 Security Boulevard, Baltimore, 

Maryland 21244–1850. 

Dated: December 13, 2011. 

Martique Jones, 

Director, Regulations Development Group, 

Division B Office of Strategic Operations and 

Regulatory Affairs. 

[FR Doc. 2011–32290 Filed 12–15–11; 8:45 a.m.] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–9068–N] 

Medicare and Medicaid Programs; 

Quarterly Listing of Program 

Issuances—July Through September 

2011 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Notice. 

SUMMARY: This quarterly notice lists 

CMS manual instructions, substantive 

and interpretive regulations, and other 

Federal Register notices that were 

published from July through September 

2011, relating to the Medicare and 


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Medicaid programs and other programs 

administered by CMS. 

FOR FURTHER INFORMATION CONTACT: It is 

possible that an interested party may 

need specific information and not be 

able to determine from the listed 

information whether the issuance or 

regulation would fulfill that need. 

Consequently, we are providing contact 

persons to answer general questions 

concerning each of the addenda 

published in this notice. 

Addenda Contact Phone number 

I CMS Manual Instructions ....................................................................... Ismael Torres .................................................... (410) 786–1864 

II Regulation Documents Published in the Federal Register ................. Terri Plumb ....................................................... (410) 786–4481 

III CMS Rulings ........................................................................................ Tiffany Lafferty .................................................. (410) 786–7548 

IV Medicare National Coverage Determinations ..................................... Wanda Belle ..................................................... (410) 786–7491 

V FDA–Approved Category B IDEs ......................................................... John Manlove ................................................... (410) 786–6877 

VI Collections of Information .................................................................... Mitch Bryman .................................................... (410) 786–5258 

VII Medicare –Approved Carotid Stent Facilities ..................................... Sarah J. McClain .............................................. (410) 786–2294 

VIII American College of Cardiology-National Cardiovascular Data Registry Sites.JoAnna Baldwin, MS ........................................ (410) 786–7205 

IX Medicare’s Active Coverage-Related Guidance Documents .............. Lori Ashby ......................................................... (410) 786–6322 

X One-time Notices Regarding National Coverage Provisions ............... Lori Ashby ......................................................... (410) 786–6322 

XI National Oncologic Positron Emission Tomography Registry Sites ... Stuart Caplan, RN, MAS .................................. (410) 786–8564 

XII Medicare-Approved Ventricular Assist Device (Destination Therapy) 

Facilities.

JoAnna Baldwin, MS ........................................ (410) 786–7205 

XIII Medicare-Approved Lung Volume Reduction Surgery Facilities ...... JoAnna Baldwin, MS ........................................ (410) 786–7205 

XIV Medicare-Approved Bariatric Surgery Facilities ................................ Kate Tillman, RN, MAS .................................... (410) 786–9252 

XV Fluorodeoxyglucose Positron Emission Tomography for Dementia 

Trials.

Stuart Caplan, RN, MAS .................................. (410) 786–8564 

All Other Information ................................................................................ Annette Brewer ................................................. (410) 786–6580 

I. Background 

Among other things, the Centers for 

Medicare & Medicaid Services (CMS) is 

responsible for administering the 

Medicare and Medicaid programs and 

coordination and oversight of private 

health insurance. Administration and 

oversight of these programs involves the 

following: (1) Furnishing information to 

Medicare and Medicaid beneficiaries, 

health care providers, and the public; 

and (2) maintaining effective 

communications with CMS regional 

offices, State governments, State 

Medicaid agencies, State survey 

agencies, various providers of health 

care, all Medicare contractors that 

process claims and pay bills, National 

Association of Insurance Commissioners 

(NAIC), health insurers, and other 

stakeholders. To implement the various 

statutes on which the programs are 

based, we issue regulations under the 

authority granted to the Secretary of the 

Department of Health and Human 

Services under sections 1102, 1871, 

1902, and related provisions of the 

Social Security Act (the Act) and Public 

Health Service Act. We also issue 

various manuals, memoranda, and 

statements necessary to administer and 

oversee the programs efficiently. 

Section 1871(c) of the Act requires 

that we publish a list of all Medicare 

manual instructions, interpretive rules, 

statements of policy, and guidelines of 

general applicability not issued as 

regulations at least every 3 months in 

the Federal Register. 

II. Summary of the Solicitation for 

Comments and Response to Comments 

As explained in the notice with 

comment period that published in the 

August 8, 2011 Federal Register (76 FR 

48564), technology has advanced since 

we published our first notice on June 9, 

1988, and the information provided in 

this notice is now available in more 

efficient, economical, and accessible 

ways to meet the requirement for 

publication set forth in the statute. Each 

quarter, we publish the most current 

and relevant information; however, 

many of the quarterly notices simply 

duplicate the information that was 

previously published, since there often 

are no new relevant updates in some 

categories for the quarter. In addition, 

there is a 3-month lapse between the 

information available on the Web site 

and information covered by this 

quarterly notice. 

In the August 8, 2011 notice (76 FR 

48564), we solicited comments on 

alternative formats to provide this 

information to the public. For example, 

we explained that we could publish a 

notice that provided only Web links to 

the addenda, or provide this 

information on a newly-created CMS 

Quarterly Issuance Web page. We 

solicited comments and any additional 

information as to whether these 

alternative processes would improve 

accessibility to information. We also 

inquired whether a new format would 

pose a problem to those who access the 

information contained in this notice or 

pose an unintended burden to 

beneficiaries, providers, and suppliers. 

We did not receive any comments in 

response to our solicitation. 

III. Revised Format for the Quarterly 

Issuance Notices 

While we are publishing the quarterly 

notice required by section 1871(c) of the 

Act, we will no longer republish 

duplicative information that is available 

to the public elsewhere. We believe this 

approach is in alignment with CMS’ 

commitment to the general principles of 

the President’s Executive Order 13563 

released January 2011entitled 

‘‘Improving Regulation and Regulatory 

Review,’’ which promotes modifying 

and streamlining an agency’s regulatory 

program to be more effective in 

achieving regulatory objectives. Section 

6 of Executive Order 13563 requires 

agencies to identify regulations that may 

be ‘‘outmoded, ineffective, insufficient, 

or excessively burdensome, and to 

modify, streamline, expand or repeal 

them in accordance with what has been 

learned.’’ This approach is also in 

alignment with the President’s Open 

Government and Transparency Initiative 

that establishes a system of 

transparency, public participation, and 

collaboration. 

Therefore, beginning with this 

quarterly notice, we will provide only 

the specific updates that have occurred 

in the 3-month period along with a 

hyperlink to the full listing that is 

available on the CMS Web site or the 

appropriate data registries that are used 

as our resources. This information is the 

most current up-to-date information, 

and will be available earlier than we 

publish our quarterly notice. We believe 


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the Web site list provides more timely 

access for beneficiaries, providers, and 

suppliers. We also believe the Web site 

offers a more convenient tool for the 

public to find the full list of qualified 

providers for these specific services and 

offers more flexibility and ‘‘real 

time’’accessibility. In addition, many of 

the Web sites have listservs; that is, the 

public can subscribe and receive 

immediate notification of any updates to 

the Web site. These listservs avoid the 

need to check the Web site, as 

notification of updates is automatic and 

sent to the subscriber as they occur. If 

assessing a Web site proves to be 

difficult, the contact person listed can 

provide information. 

IV. How To Use the Notice 

This notice is organized into 15 

addenda so that a reader may access the 

subjects published during the quarter 

covered by the notice to determine 

whether any are of particular interest. 

We expect this notice to be used in 

concert with previously published 

notices. Those unfamiliar with a 

description of our Medicare manuals 

should view the manuals at http://www.

cms.gov/manuals. 

Authority: (Catalog of Federal Domestic 

Assistance Program No. 93.773, Medicare— 

Hospital Insurance, Program No. 93.774, 

Medicare—Supplementary Medical 

Insurance Program, and Program No. 93.714, 

Medical Assistance Program) . 

Dated: December 8, 2011 . 

Jacquelyn Y. White, 

Director, Office of Strategic Operations and 

Regulatory Affairs. 

BILLING CODE 4120–01–P 


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[FR Doc. 2011–32107 Filed 12–15–11; 8:45 am] 

BILLING CODE 4120–01–C 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–1586–N] 

Medicare Program; First Semi-Annual 

Meeting of the Advisory Panel on 

Hospital Outpatient Payment (HOP— 

Formerly Known as the Advisory Panel 

on Ambulatory Payment Classification 

Groups—APC Panel)—February 27, 28, 

and 29, 2012 

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), formerly known as the 

Advisory Panel on Ambulatory Payment 

Classification Groups (the APC Panel) 

for 2012. 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 supervision issues. 

DATES: Meeting Date: The first semiannual meeting in 2012 is scheduled for 

the following dates and times: 

• Monday, February 27, 2012, 1 p.m. 

to 5 p.m. eastern standard time (e.s.t.) 1

• Tuesday, February 28, 2012, 9 a.m. 

to 5 p.m. (e.s.t.) 1

• Wednesday, February 29, 2012, 9 

a.m. to 5 p.m. (e.s.t.) 1

Note: 1The times listed in this notice are 

approximate times; consequently, the 

meetings may last longer than listed in this 

notice, but will not begin before the posted 

times. 

Deadlines 

Deadline for Presentations and 

Comments (which includes both 

hardcopy and email submissions)—5 

p.m. (e.s.t.), Friday, December 30, 2011. 

(See below for submission instructions.) 

Deadline for Meeting Registration 

(Note: Those who do not pre register 

may not be able to attend the meeting 

since seating space is limited)—5 p.m. 

(e.s.t.), Friday, January 27, 2012. 

Deadline for Requests for Special 

Accommodations—5 p.m. (e.s.t.), 

Friday, January 27, 2012. 

Submission Instructions for 

Presentations and Comments 

Because of staffing and resource 

limitations, we cannot accept written 

comments and or presentations by FAX, 

nor can we print written comments and 

presentations received by email for 

dissemination at the meeting. 

Presentations: 

Presentations must be based on 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, and which types of 

practitioners are permitted to supervise 

hospital outpatient services. 

All presentations will be considered 

public information and will be posted 

on the CMS Web site. Presenters should 

not send pictures of patients in any of 

the documents (unless their faces have 

been blocked out) or include any 

examples with patient 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. We note that all 

presentations are limited to 5 minutes 

per individual or organization. 

2. An email copy of your 

presentations sent to the Panel mailbox, 

APCPanel.cms.hhs.gov or to the DFO, 

Paula.Smith@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 person that 

can answer any questions and or 

provide revisions that are requested for 

the presentation. 

Æ Presenters must clearly explain the 

actions 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. 

ADDRESSES: Meeting Location: The 

meeting will be held in the Auditorium, 

CMS Central Office, 7500 Security 

Boulevard, Woodlawn, Maryland 

21244–1850. 

FOR FURTHER INFORMATION CONTACT: For 

inquiries about the Panel, contact the 

Designated Federal Officier (DFO): 

Paula Smith, 7500 Security Boulevard, 

Mail Stop C4–05–17, Woodlawn, MD 

21244–1850. Phone: (410) 786–4709. 

Mail hardcopies and email copies to 

the following addresses: 

Paula Smith, DFO, CMS, CM, HAPC, 

DOC—HOPS Panel, 7500 Security 

Blvd., Woodlawn, MD 21244–1850, 

Mail Stop C4–05–17, Paula.Smith@

cms.hhs.gov or APCPanel@cms.hhs.

gov. 

Note: We recommend that you advise 

couriers of the following information: When 

delivering hardcopies of presentations to 

CMS, if no one answers at the above phone 

number, call (410) 786–4532 or (410) 786– 

7267. 

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) 

786–9379 (local). 

Web Sites: For additional information 

on the Panel and updates to the Panel’s 

activities, we are referring readers to 

view our Web site at the following: 

http://www.cms.hhs.gov/FACA/05_

AdvisoryPanelonAmbulatoryPayment

ClassificationGroups.asp#TopOfPage. 

(Use control + click the mouse in order 

to access the previous URL.) 

Note: There is an underscore after FACA/ 

05 (like this_); there is no space. 

You may also search information 

about the Panel and its membership in 

the FACA database at the following 

URL: https://www.fido.gov/ 

facadatabase/public.asp. 

SUPPLEMENTARY INFORMATION: 

I. Background 

The Secretary of the Department of 

Health and Human Services (DHHS) 

(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 Hospital Outpatient 

Payment (HOP) 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 

(FACA) (Pub. L. 92–463), as amended (5 

U.S.C. Appendix 2), which sets forth 

standards for the formation and use of 

advisory panels. 


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