12322 Federal Register / Vol. 78, No. 36 / Friday, February 22, 2013 / Notices 

Dated: February 15, 2013. 

Martique Jones, 

Deputy Director, Regulations Development 

Group, Office of Strategic Operations and 

Regulatory Affairs. 

[FR Doc. 2013–04015 Filed 2–21–13; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifier: CMS–R–282] 

Agency Information Collection 

Activities: Proposed Collection; 

Comment Request 

AGENCY: Centers for Medicare & 

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: Extension. Title of Information 

Collection: Medicare Advantage 

Appeals and Grievance Data Disclosure 

Requirements (42 CFR 422.111). Use: 

Section 1852(c)(2)(C) of the Social 

Security Act and 42 CFR 422.111(c)(3) 

require that Medicare Advantage (MA) 

organizations and demonstrations 

disclose information pertaining to the 

number of disputes, and their 

disposition in the aggregate, with the 

categories of grievances and appeals to 

any individual eligible to elect an MA 

organization who requests this 

information. MA organizations and 

demonstrations remain under a 

requirement to collect and provide this 

information to individuals eligible to 

elect an MA organization, we continue 

to need the same format and form for 

reporting. Form Number: CMS–R–282 

(OCN 0938–0778). Frequency: Annually 

and semi-annually. Affected Public: 

Private Sector (business or other forprofit and not-for-profit institutions). 

Number of Respondents: 51,370. Total 

Annual Responses: 52,260. Total 

Annual Hours: 5,414. (For policy 

questions regarding this collection 

contact Stephanie Simons at 206–615– 

2420. 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 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 April 23, 2013: 

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: February 19, 2013. 

Martique Jones, 

Deputy Director, Regulations Development 

Group, Office of Strategic Operations and 

Regulatory Affairs. 

[FR Doc. 2013–04120 Filed 2–21–13; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifier: CMS–10430, CMS– 

10164 and CMS–838] 

Agency Information Collection 

Activities: OMB Review; Comment 

Request 

AGENCY: Centers for Medicare & 

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: Reinstatement of a previously 

approved collection; Title: Information 

Collection Requirements for Compliance 

with Individual and Group Market 

Reforms under Title XXVII of the Public 

Health Service Act; Use: The provisions 

of title XXVII of the Public Health 

Service Act (PHS Act) are designed to 

make it easier for people to get access 

to health care coverage and to reduce 

the limitations that can be put on the 

coverage. Sections 2723 and 2761 of the 

PHS Act direct CMS to enforce a 

provision (or provisions) of title XXVII 

of the PHS Act with respect to health 

insurance issuers when a state has 

notified CMS that it has not enacted 

legislation to enforce or that it is not 

otherwise enforcing a provision (or 

provisions) of the individual and group 

market reforms with respect to health 

insurance issuers, or when CMS has 

determined that a state is not 

substantially enforcing one or more of 

those provisions. This collection also 

pertains to notices issued by individual 

and group health insurance issuers and 

self-funded non-Federal governmental 

plans. This collection includes the 

issuance of certificates of creditable 

coverage; notification of preexisting 

condition exclusions; notification of 

special enrollment rights; and review of 

issuers’ filings of individual and group 

market products or similar Federal 

review in cases in which a state is not 

enforcing a title XXVII individual or 

group market provision. This 

information collection is a reinstatement 

of a previously approved collection 

(which expired on September 30, 2012 

(OMB#: 0938–0702 and OMB#: 0938– 

0703)) with minimal changes to reflect 


sroberts on DSK5SPTVN1PROD with NOTICES
Federal Register / Vol. 78, No. 36 / Friday, February 22, 2013 / Notices 12323 

laws passed since the previous 

collection document was approved. 

While the OMB control number for this 

proposed collection will remain the 

same as the previously approved 

collection, this proposed collection will 

be given a new CMS Form Number. 

Form Number: CMS–10430 (OCN: 

0938–0702); Frequency: Annually; 

Occasionally; Affected Public: Private 

Sector; Business or other for-profits and 

Not-for-profit institutions, and State, 

Local, or Tribal Governments; Number 

of Respondents: 8,716; Total Annual 

Responses: 39,831,442; Total Annual 

Hours: 3,760,422 hours. (For policy 

questions regarding this collection 

contact Lisa Campbell at 301–492–4114. 

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

2. Type of Information Collection 

Request: Reinstatement with a change of 

a previously approved collection; Title: 

Medicare Electronic Data Interchange 

(EDI) Registration and Electronic Data 

Interchange (EDI) Enrollment Form; 

Use: The purpose of this collection is to 

obtain information that will be 

subsequently used during transaction 

exchange for identification of Medicare 

providers/suppliers and authorization of 

requested Electronic Data Interface (EDI) 

functions. The EDI Enrollment and the 

Medicare Registration Forms are 

completed by Medicare providers, 

suppliers, or both suppliers and 

submitted to Medicare contractors. 

Authorization is needed for providers 

and suppliers to send and receive 

HIPAA standard transactions directly 

(or through a designated 3rd party) to 

and from Medicare contractors. 

Medicare contractors would use the 

information for initial set-up and 

maintenance of the access privileges. 

The use of the standard form provides 

an efficient uniform means by which 

Medicare captures information 

necessary to drive Medicare EDI 

security and EDI access privileges. All 

EDI providers will complete and sign 

the EDI Enrollment Form along with the 

Medicare EDI Registration Form. They 

will also reconfirm their access 

privileges annually. 

The information collected will be 

uploaded into Medicare contractor 

computer systems. Medicare contractors 

will store this information in a database 

accessed at the time of provider 

connection to the Medicare Data 

Contractor Network (MDCN). When 

authentication is successful and 

connectivity is established, transactions 

may be exchanged. The information will 

be stored in a computer data base and 

used to authenticate the user on day-today electronic commerce, support the 

submitter and password administration 

function, and validate access 

relationships between providers/ 

suppliers and their designated EDI 

submitter/receiver on a per transaction 

basis. Form Number: CMS–10164 (OCN: 

0938–0983); Frequency: Once; Affected 

Public: Private Sector—Business or 

other for-profits, Not for-profit 

institutions; Number of Respondents: 

240,000; Total Annual Responses: 

240,000; Total Annual Hours: 80,000. 

(For policy questions regarding this 

collection contact Claudette Sikora at 

410–786–5618. For all other issues call 

410–786–1326.) 

3. Type of Information Collection 

Request: Reinstatement without change 

of a previously approved collection. 

Title of Information Collection: 

Medicare Credit Balance Reporting 

Requirements and Supporting 

Regulations in 42 CFR 405.371, 405.378 

and 413.20; Use: Section 1815(a) of the 

Social Security Act authorizes the 

Secretary to request information from 

providers which is necessary to 

properly administer the Medicare 

program. Quarterly credit balance 

reporting is needed to monitor and 

control the identification and timely 

collection of improper payments. The 

information obtained from Medicare 

credit balance reports will be used by 

the contractors to identify and recover 

outstanding Medicare credit balances 

and by Federal enforcement agencies to 

protect Federal funds. The information 

will also be used to identify the causes 

of credit balances and to take corrective 

action. Form Number: CMS–838 (OCN: 

0938–0600); Frequency: Yearly; Affected 

Public: Private sector—Business or other 

for-profits; Number of Respondents: 

45,838; Total Annual Responses: 

183,352; Total Annual Hours: 550,056. 

(For policy questions regarding this 

collection contact Milton Jacobson at 

410–786–7553. 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, and phone number as well the 

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 March 25, 2013. 

OMB, Office of Information and 

Regulatory Affairs, Attention: CMS 

Desk Officer, Fax Number: (202) 395– 

6974, Email: 

OIRA_submission@omb.eop.gov. 

Dated: February 19, 2013. 

Martique Jones, 

Deputy Director, Regulations Development 

Group, Office of Strategic Operations and 

Regulatory Affairs. 

[FR Doc. 2013–04135 Filed 2–21–13; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–3279–N] 

Announcement of the Re-Approval of 

the Commission on Office Laboratory 

Accreditation (COLA) as an 

Accreditation Organization Under the 

Clinical Laboratory Improvement 

Amendments of 1988 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Notice. 

SUMMARY: This notice announces the 

application of the Commission on Office 

Laboratory Accreditation (COLA) for 

approval as an accreditation 

organization for clinical laboratories 

under the Clinical Laboratory 

Improvement Amendments of 1988 

(CLIA) program. We have determined 

that COLA meets or exceeds the 

applicable CLIA requirements. In this 

notice, we announce the approval and 

grant COLA deeming authority for a 

period of 6 years. 

DATES: Effective Date: This notice is 

effective from February 22, 2013 to 

February 22, 2019. 

FOR FURTHER INFORMATION CONTACT: 

Raelene Perfetto, (410) 786–6876. 

SUPPLEMENTARY INFORMATION: 

I. Background and Legislative 

Authority 

On October 31, 1988, the Congress 

enacted the Clinical Laboratory 

Improvement Amendments of 1988 

(CLIA) (Pub. L. 100–578). CLIA 

amended section 353 of the Public 

Health Service Act. We issued a final 

rule implementing the accreditation 

provisions of CLIA on July 31, 1992 (57 

FR 33992). Under those provisions, 

CMS may grant deeming authority to an 

accreditation organization if its 

requirements for laboratories accredited 

under its program are equal to or more 

stringent than the applicable CLIA 

program requirements in 42 CFR part 

493 (Laboratory Requirements). Subpart 


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