16790 Federal Register / Vol. 76, No. 58 / Friday, March 25, 2011 / Notices 

information collection and 

recordkeeping requirements must be 

mailed and/or faxed to the designees 

referenced below by April 25, 2011. 

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, Room C4–26–05, 7500 

Security Boulevard, Baltimore, 

Maryland 21244–1850. 

3. By Facsimile or E-mail to OMB. 

OMB, Office of Information and 

Regulatory Affairs, Attention: CMS Desk 

Officer, Fax Number: (202) 395–6974, Email: OIRA_submission@omb.eop.gov. 

Dated: March 18, 2011. 

Martique Jones, 

Director, Regulations Development Group, 

Division B, Office of Strategic Operations and 

Regulatory Affairs. 

[FR Doc. 2011–7106 Filed 3–24–11; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare and Medicaid 

Services 

[Document Identifier CMS–370, CMS–377, 

CMS–378; CMS–10145, CMS–10362, CMS– 

10384, CMS–10342 and CMS–10338] 

Agency Information Collection 

Activities: Proposed Collection; 

Comment Request 

AGENCY: Centers for Medicare and 

Medicaid Services, HHS. 

In compliance with the requirement 

of section 3506(c)(2)(A) of the 

Paperwork Reduction Act of 1995, the 

Centers for Medicare & Medicaid 

Services (CMS) is publishing the 

following summary of proposed 

collections for public comment. 

Interested persons are invited to send 

comments regarding this burden 

estimate or any other aspect of this 

collection of information, including any 

of the following subjects: (1) The 

necessity and utility of the proposed 

information collection for the proper 

performance of the agency’s functions; 

(2) the accuracy of the estimated 

burden; (3) ways to enhance the quality, 

utility, and clarity of the information to 

be collected; and (4) the use of 

automated collection techniques or 

other forms of information technology to 

minimize the information collection 

burden. 

1. Type of Information Collection 

Request: Revision of a currently 

approved collection; Titles of 

Information Collection: (CMS–370) 

Health Insurance Benefits Agreement, 

(CMS–377) ASC Request for 

Certification or Update of Certification 

Information in the Medicare Program, 

and (CMS–378) Ambulatory Surgical 

Center (ASC) Survey Report Form; Use: 

CMS–370 has not been revised and will 

continue to be used to establish 

eligibility for payment under Title XVIII 

of the Social Security Act (the ‘‘Act’’). As 

revised, CMS–377 will be used to 

collect facility-specific characteristics 

that facilitate CMS’ oversight of ASCs. 

The data also enables CMS to respond 

to inquiries from the Congress, GAO, 

and the OIG concerning the 

characteristics of Medicare-participating 

ASCs. The data base that supports 

survey and certification activities will 

be revised to reflect changes in the data 

fields on this revised form, such as the 

data on the types of surgical procedures 

performed in the ASC. CMS–378 will be 

discontinued since it duplicates 

information collected by other means; 

Form Numbers: CMS–370, –377 and 

–378 (OCN: 0938–0266); Frequency: 

Occasionally (initially an then every 

three years); Affected Public: Private 

Sector: Business or other for-profit and 

Not-for-profit institutions; Number of 

Respondents: 7,213; Total Annual 

Responses: 1,795; Total Annual Hours: 

648. (For policy questions regarding this 

collection contact Gail Vong at 410– 

786–0787. For all other issues call 410– 

786–1326.) 

2. Type of Information Collection 

Request: Extension without change of a 

currently approved collection; Title of 

Information Collection: Medicare Part B 

Drug and Biological Competitive 

Acquisition Program (CAP) and 

Supporting Regulations in 42 CFR 

Sections 414.906, 414.908, 414.910, 

414.914, 414.916, and 414.917; Use: 

Section 303(d) of the Medicare 

Prescription Drug, Improvement, and 

Modernization Act of 2003 (MMA) 

provides an alternative payment 

methodology for Part B covered drugs 

that are not paid on a cost or 

prospective payment basis. In 

particular, Section 303(d) of the MMA 

amends Title XVIII of the Social 

Security Act by adding a new section 

1847B, which establishes a competitive 

acquisition program for the acquisition 

of and payment for Part B covered drugs 

and biologicals furnished on or after 

January 1, 2006. Since its inception, 

additional legislation has augmented the 

CAP. Section 108 of the Medicare 

Improvements and Extension Act under 

Division B, Title I of the Tax Relief 

Health Care Act of 2006 (MIEA–TRHCA) 

amended Section 1847b(a)(3) of the 

Social Security Act and requires that 

CAP implement a post payment review 

process. This procedure is done to 

assure that payment is made for a drug 

or biological under this section only if 

the drug or biological has been 

administered to a beneficiary. Form 

Number: CMS–10145 (OCN: 0938– 

0945); Frequency: Weekly, quarterly and 

occasionally; Affected Public: Private 

sector—Business or other for-profit and 

Not-for-profit institutions; Number of 

Respondents: 3000; Total Annual 

Responses: 156,020; Total Annual 

Hours: 31,208. 

3. Type of Information Collection 

Request: New collection; Title of 

Information Collection: Autism 

Spectrum Disorders (ASD): State of the 

States Services and Supports for People 

with ASD; Use: The information that is 

collected in the interviews will be used 

to communicate additional information 

about services available to people with 

ASD and the public policy issues that 

affect people with ASD to key 

stakeholder audiences. The format of 

the report will include data tables from 

various state programs and narrative 

about the data being presented based on 

the interviews with state agency staff. 

We propose interviewing multiple staff 

in each state because several state 

agencies have an impact on services and 

supports for people with ASD; Form 

Number: CMS–10362 (OCN: 0938– 

New); Frequency: Once; Affected Public: 

State, local, or Tribal Governments; 

Number of Respondents: 459; Total 

Annual Responses: 459; Total Annual 

Hours: 803. (For policy questions 

regarding this collection contact Ellen 

Blackwell at 410–786–4498. For all 

other issues call 410–786–1326.) 

4. Type of Information Collection 

Request: New Collection; Title of 

Information Collection: Health 

Insurance Assistance Database; Use: In 

October 2010, the Office of Consumer 

Support began to take and respond to 

direct consumer inquiries related to the 

Affordable Care Act. As of February 

15th 2011, CCIIO has received 906 

consumer inquiries. Consumer inquiries 

continue to come in to CCIIO at a rate 

of 30 to 35 inquiries per week. Starting 

in January 2011, the HHS Hotline will 

begin to refer ACA calls to CCIIO. To 

date, the HHS Hotline receives, on 

average, 400 calls per month pertaining 

to ACA. 

Accordingly, a system to collect, track 

and store consumer information is 

urgently needed in order to accomplish 


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Federal Register / Vol. 76, No. 58 / Friday, March 25, 2011 / Notices 16791 

successful case management to ensure 

that the information, coverage, and 

health care needs of consumers are 

addressed fairly and in a timely fashion. 

Further, the Team will provide detailed 

reports on these consumer inquiries 

with a focus on Affordable Care Act and 

PHS Act compliance issues. These 

reports will assist the Office of 

Oversight in identifying areas where 

compliance concerns may arise. Reports 

will be stripped of any information in 

identifiable form (IIF) and personal 

health information when written and 

prepared. Authority for maintenance, 

collection and disclosures of this 

information is given under sections 

2719, 2723, and 2761 of the Public 

Health Service Act (PHS Act) and 

section 1321(c) of the Affordable Care 

Act. 

Analysis of this data reporting will 

help identity patterns of practice in the 

insurance marketplaces and uncover 

suspected patterns of noncompliance. 

HHS may share program data reports 

with the Departments of Labor and 

Treasury, and State regulators. Program 

data also can offer CCIIO one indication 

of the effectiveness of State 

enforcement, affording opportunities to 

provide technical assistance and 

support to State insurance regulators 

and, in extreme cases, inform the need 

to trigger federal enforcement. Form 

Number: CMS–10384 (OCN: 0938– 

New); Frequency: Occasionally; 

Affected Public: Individuals or 

households; Number of Respondents: 

1200; Number of Responses: 1,860; 

Total Annual Hours: 195 (For policy 

questions regarding this collection, 

contact Paul Tibbits (301) 492–4229. For 

all other issues call (410) 786–1326.) 

5. Type of Information Collection 

Request: Extension of a currently 

approved collection; Title of 

Information Collection: Annual Limits 

Waiver Online Application Form; Use: 

Under section 2711(a)(2) of the Public 

Health Service Act, as amended by the 

Affordable Care Act section 1302(b), 

The Secretary of Health and Human 

Services is required to impose 

restrictions on the dollar value of 

essential benefits provided by new or 

existing group health plans or 

individual policies in the market 

between September 23, 2010 and 

January 1, 2014. The interim final 

regulations published June 28, 2010 

(45 CFR § 147.126) give the Secretary 

the authority to waive these restricted 

annual limits if compliance would 

result in a significant increase in 

premium or significant decrease in 

access to benefits for those already 

covered. CMS is in the process of 

evaluating applications for waivers of 

annual limits and seeks to publish an 

updated Microsoft Excel spreadsheet to 

standardize and simplify the data 

collection process. Applicants must fill 

out (1) spreadsheet per application. The 

spreadsheet is a mandatory component 

of each waiver application necessary to 

fulfill the statutory requirements under 

section 2711(a)(2) of the Public Health 

Service Act. The information collected 

includes applicant contact information; 

information about the annual limit(s) on 

the overall plan or policy and on 

essential health benefits (as defined by 

the Affordable Care Act section 

1302(b)); information about plan design 

such as copayment, coinsurance, and 

deductibles; financial projections by 

enrollee tier; and a description of how 

a significant decrease in access to 

benefits would result from compliance 

with section 2711(a)(2) of the Affordable 

Care Act. This information is required to 

accurately and objectively assess 

whether compliance with the restricted 

annual limits would result in the 

aforementioned significant increase in 

premium or significant decrease in 

access to benefits, on which the grant of 

a waiver is conditioned in the interim 

final regulations. The updated 

spreadsheet contains a more detailed 

description of what values should be 

entered into each cell. This description 

should save applicants time when 

completing the spreadsheet initially, 

and it should lessen the need for 

applicants to go back and correct 

mistakes after submission. Form 

Number: CMS–10342 (OCN: 0938– 

1105); Frequency: Annually; Affected 

Public: Private Sector; Number of 

Respondents: 4,872; Number of 

Responses: 4,608,372; Total Annual 

Hours: 178,183. (For policy questions 

regarding this collection, contact Erika 

Kottenmeier at (301) 492–4170. For all 

other issues call (410) 786–1326.) 

6. Type of Information Collection 

Request: Extension of a currently 

approved collection; Title of 

Information Collection: Affordable Care 

Act Internal Claims and Appeals and 

External Review Procedures for Nongrandfathered Group Health Plans and 

Issuers and Individual Market Issuers; 

Use: The Patient Protection and 

Affordable Care Act, Public Law 111– 

148, (the Affordable Care Act) was 

enacted by President Obama on March 

23, 2010. As part of the Act, Congress 

added PHS Act section 2719, which 

provides rules relating to internal claims 

and appeals and external review 

processes. These interim final 

regulations (IFR) set forth rules 

implementing PHS Act section 2719 for 

internal claims and appeals and external 

review processes. With respect to 

internal claims and appeals processes 

for group health coverage, PHS Act 

section 2719 and paragraph (b)(2)(i) of 

the interim final regulations provide 

that group health plans and health 

insurance issuers offering group health 

insurance coverage must comply with 

the internal claims and appeals 

processes set forth in 29 CFR 2560.503– 

1 (the DOL claims procedure regulation) 

and update such processes in 

accordance with standards established 

by the Secretary of Labor in paragraph 

(b)(2)(ii) of the regulations. Paragraph 

(b)(3)(i) requires issuers offering 

coverage in the individual health 

insurance market to also comply with 

the DOL claims procedure regulation as 

updated by the Secretary of HHS in 

paragraph (b)(3)(ii) of the interim final 

regulations for their internal claims and 

appeals processes. 

The DOL claims procedure regulation 

requires plans to provide every claimant 

who is denied a claim with a written or 

electronic notice that contains the 

specific reasons for denial, a reference 

to the relevant plan provisions on which 

the denial is based, a description of any 

additional information necessary to 

perfect the claim, and a description of 

steps to be taken if the participant or 

beneficiary wishes to appeal the denial. 

The regulation also requires that any 

adverse decision upon review be in 

writing (including electronic means) 

and include specific reasons for the 

decision, as well as references to 

relevant plan provisions. In addition, 

paragraph (b)(3)(ii)(C) of the interim 

final regulations adds an additional 

requirement that non-grandfathered 

ERISA-covered group health plans 

provide to the claimant, free of charge, 

any new or additional evidence 

considered relied upon, or generated by 

the plan or issuer in connection with 

the claim. 

Also PHS Act section 2719 and these 

interim final regulations provide that 

group health plans and issuers offering 

group health insurance coverage must 

comply either with a State external 

review process or a Federal review 

process. The regulations provide a basis 

for determining when plans and issuers 

must comply with an applicable State 

external review process and when they 

must comply with the Federal external 

review process. Form Number: CMS– 

10338 (OCN: 0938–1099); Frequency: 

Occasionally; Affected Public: State, 

Local, Tribal Governments; Number of 

Respondents: 36,344; Number of 

Responses: 2,762,824; Total Annual 

Hours: 211,216,845. (For policy 

questions regarding this collection, 


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16792 Federal Register / Vol. 76, No. 58 / Friday, March 25, 2011 / Notices 

contact Tara Oakman at (301) 492–4253. 

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 

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 at 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 May 24, 2011: 

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, Room C4–26–05, 7500 

Security Boulevard, Baltimore, 

Maryland 21244–1850. 

Dated: March 18, 2011. 

Martique Jones, 

Director, Regulations Development Group, 

Division B, Office of Strategic Operations and 

Regulatory Affairs. 

[FR Doc. 2011–7104 Filed 3–24–11; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare and Medicaid 

Services 

[Document Identifier CMS–10328 and CMS– 

10319] 

Agency Information Collection 

Activities: Submission for OMB 

Review; Comment Request 

AGENCY: Centers for Medicare and 

Medicaid Services, HHS. 

In compliance with the requirement 

of section 3506(c)(2)(A) of the 

Paperwork Reduction Act of 1995, the 

Centers for Medicare & Medicaid 

Services (CMS), Department of Health 

and Human Services, is publishing the 

following summary of proposed 

collections for public comment. 

Interested persons are invited to send 

comments regarding this burden 

estimate or any other aspect of this 

collection of information, including any 

of the following subjects: (1) The 

necessity and utility of the proposed 

information collection for the proper 

performance of the Agency’s function; 

(2) the accuracy of the estimated 

burden; (3) ways to enhance the quality, 

utility, and clarity of the information to 

be collected; and (4) the use of 

automated collection techniques or 

other forms of information technology to 

minimize the information collection 

burden. 

1. Type of Information Collection 

Request: Revision of currently approved 

collection; Title of Information 

Collection: Medicare Self-Referral 

Disclosure Protocol; Use: Section 6409 

of the ACA requires the Secretary to 

establish and post information on the 

CMS’ public Internet Web site 

concerning a self-referral disclosure 

protocol (SRDP) that sets forth a process 

for providers of services and suppliers 

to self-disclose actual or potential 

violations of section 1877 of the Act. In 

addition, section 6409(b) of the ACA 

gives the Secretary authority to reduce 

the amounts due and owing for the 

violations. This information collection 

request is necessary in order to inform 

the public of the process and the types 

of information needed to participate in 

the SRDP. 

The SRDP is a voluntary selfdisclosure instrument that will allow 

providers of services and suppliers to 

disclose actual or potential violations of 

section 1877 of the Act. CMS will 

analyze the disclosed conduct to 

determine compliance with section 

1877 of the Act and the application of 

the exceptions to the physician selfreferral prohibition. In addition, the 

authority granted to the Secretary under 

section 6409(b) of the ACA, and 

subsequently delegated to CMS, may be 

used to reduce the amount due and 

owing for violations. Form Number: 

CMS–10328 (OMB#: 0938–1106; 

Frequency: Once; Affected Public: 

Private Sector, Business and other forprofit and not-for-profit institutions; 

Number of Respondents: 50; Total 

Annual Responses: 50; Total Annual 

Hours: 1,175. (For policy questions 

regarding this collection contact Ronke 

Fabayo at 410–786–4460. For all other 

issues call 410–786–1326.) 

2. Type of Information Collection 

Request: Extension of a currently 

approved collection; Title of 

Information Collection: Pre-Existing 

Condition Insurance Plan Program 

Solicitation and Contractor’s Proposal 

Package; Use: The Department of Health 

and Human Services (HHS) is 

requesting a renewal of this package by 

the Office of Management and Budget 

(OMB); specifically, HHS is now seeking 

a three-year approval for this collection. 

On March 23, 2010, the President signed 

into law H.R. 3590, the Patient 

Protection and Affordable Care Act 

(Affordable Care Act), Public Law 111– 

148. Section 1101 of the law establishes 

a ‘‘temporary high risk health insurance 

pool program’’ (which has been named 

the Pre-Existing Condition Insurance 

Plan, or PCIP) to provide health 

insurance coverage to currently 

uninsured individuals with pre-existing 

conditions. The law authorizes HHS to 

carry out the program directly or 

through contracts with states or private, 

non-profit entities. 

This package renewal is requested as 

a result of a possible transition in 

administration of the program from a 

federally-run to a State administered 

program. A State who originally decided 

to have HHS administer the program in 

their State may in the future notify HHS 

of their desire to administer the PreExisting Condition Plan (PCIP) program. 

PCIP is also referred to as the temporary 

qualified high risk insurance pool 

program, as it is called in the Affordable 

Care Act, but we have adopted the term 

PCIP to better describe the program and 

avoid confusion with the existing state 

high risk pool programs. Form Number: 

CMS–10319 (OMB#: 0938–1085); 

Frequency: Occasionally; Affected 

Public: State governments; Number of 

Respondents: 2; Total Annual 

Responses: 2; Total Annual Hours: 

2,992. (For policy questions regarding 

this collection contact Laura Dash at 

301–492–4296. 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. 

To be assured consideration, 

comments and recommendations for the 

proposed information collections must 

be received by the OMB desk officer at 

the address below, no later than 5 p.m. 

on April 25, 2011. OMB, Office of 

Information and Regulatory Affairs, 

Attention: CMS Desk Officer, Fax 

Number: (202) 395–6974, E-mail: 

OIRA_submission@omb.eop.gov. 


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