Federal Register / Vol. 76, No. 73 / Friday, April 15, 2011 / Notices 21373 

II. Criteria for Applicants 

We are seeking eligible organizations 

which are a subsection (d) hospital, as 

defined in section 1886(d)(1)(B) of the 

Social Security Act (the Act), with high 

readmission rates that partner with 

community-based organizations (CBOs) 

or CBOs that provide care transition 

services. CBOs are defined as 

community-based organizations that 

provide care transition services across 

the continuum of care through 

arrangements with subsection (d) 

hospitals and whose governing bodies 

include sufficient representation of 

multiple health care stakeholders, 

including consumers. 

This program creates a source of 

funding for care transition services that 

effectively manage transitions from 

acute to community-based settings and 

report specified process and outcome 

measures on their results. CBOs will be 

paid on a per eligible discharge basis for 

eligible Medicare beneficiaries at high 

risk for readmission, including those 

with multiple chronic conditions, 

depression, or cognitive impairments. 

In selecting CBOs to participate in the 

program, preference will be given to 

eligible entities that are Administration 

on Aging (AoA) grantees that provide 

concurrent care transition interventions 

with multiple hospitals and 

practitioners or entities that provide 

services to medically-underserved 

populations, small communities, and 

rural areas. The program will run for 5 

years beginning April 11, 2011; 

however, participants will be awarded 

2-year agreements that may be extended 

on an annual basis for the remaining 3 

years based on performance. 

Applicants must identify root causes 

of readmissions and define their target 

population and strategies for identifying 

high risk patients. Applicants must also 

specify care transition interventions 

including strategies for improving 

provider communications in care 

transitions and improving patient 

activation. Lastly, applicants will be 

required to provide a budget including 

a per eligible discharge rate for care 

transition services, provide an 

implementation plan with milestones, 

and demonstrate prior experience with 

effectively managing care transition 

services and reducing readmissions. 

A competitive process will be used to 

select eligible organizations. We will 

accept proposals on a rolling basis. The 

program will continue through 2015. 

For specific details regarding the 

CCTP and the application process, 

please refer to the solicitation on the 

CMS Web site at http://www.cms.gov/ 

DemoProjectsEvalRpts/MD/ 

itemdetail.asp?itemID=CMS1239313. 

III. Application Information 

Please refer to file code [CMS–5055– 

N2] on the application. Proposals (an 

unbound original and 3 copies plus an 

electronic copy on CD–ROM) must be 

typed for clarity and should not exceed 

30 double-spaced pages, exclusive of 

cover letter, the executive summary, 

resumes, forms, and supporting 

documentation. Because of staffing and 

resource limitations, we cannot accept 

proposals by facsimile (FAX) 

transmission. Applicants may, but are 

not required to, submit a total of 10 

copies to assure that each reviewer 

receive a proposal in the manner 

intended by the applicant (for example, 

collated, tabulated color copies). Hard 

copies and electronic copies must be 

identical. 

IV. Eligible Organizations 

As discussed above, subsection (d) 

hospitals with high readmission rates 

that partner with CBOs or CBOs that 

provide care transition services are 

eligible to participate in the CCTP. We 

anticipate that a wide variety of 

interested parties may be eligible to 

form a CBO in order to apply in 

collaboration with other organizations 

to perform the responsibilities specified. 

CBOs may be characterized as physician 

practices, particularly primary care 

practices, a corporate entity that has a 

separate quality improvement 

organization (QIO) contract with CMS 

under Part B of title XI of the Act, in 

situations that will not result in or 

create the appearance of a conflict of 

interest between the QIO’s review tasks 

under title XI and the corporate entity’s 

role as a CBO, an Aging and Disability 

Resource Center, Area Agency on Aging, 

or other appropriate organization that 

meets the statutory definition at section 

3026(b)(1)(B) of the Act. 

Authority: Catalog of Federal Domestic 

Assistance Program No. 93.773, Medicare— 

Hospital Insurance; and Program No. 93.774, 

Medicare—Supplementary Medical 

Insurance Program. 

Dated: December 27, 2010. 

Donald M. Berwick, 

Administrator, Centers for Medicare & 

Medicaid Services. 

[FR Doc. 2011–9126 Filed 4–12–11; 11:15 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

Privacy Act of 1974; Report of a New 

System of Records 

AGENCY: Center for Consumer 

Information and Insurance Oversight 

(CCIIO), Centers for Medicare and 

Medicaid Services (CMS), Department 

of Health and Human Services (HHS). 

ACTION: Notice of a new Privacy Act 

system of records. 

SUMMARY: In accordance with the 

requirements of the Privacy Act of 1974, 

the Centers for Medicare and Medicaid 

Services (CMS), Center for Consumer 

Information and Insurance Oversight 

(CCIIO) is establishing a new system of 

records (SOR) titled the ‘‘Health 

Insurance Assistance Database (HIAD),’’ 

System No. 09–70–0586. This SOR is 

established under the authority of 

Sections 2719, 2723, and 2761 of the 

Public Health Service Act (PHS Act) 

(Public Law (Pub. L.) 97–35) and 

§ 1321(c) of the Patient Protection and 

Affordable Care Act (Affordable Care 

Act) (Pub. L. 111–148). Section 1321(c) 

of the Affordable Care Act authorizes 

HHS (1) to ensure that States with 

Exchanges are substantially enforcing 

the Federal standards to be set for the 

Exchanges and (2) to set up Exchanges 

in States that elect not to do so or are 

not substantially enforcing related 

provisions. Sections 2723 and 2761 of 

the PHS Act authorize HHS to enforce 

provisions that apply to non-Federal 

governmental plans and to enforce PHS 

Act provisions that apply to other health 

insurance coverage in States that HHS 

has determined are not substantially 

enforcing those provisions. The HIAD 

database will be maintained by the 

Office of Consumer Support Health 

Insurance Assistance Team (the Team) 

to assist the Office of Oversight with its 

compliance activities. HIAD is the 

primary tool through which the Team 

will track information for the purposes 

of oversight. 

The primary purpose of this system is 

to collect and maintain information on 

consumer inquiries and complaints 

regarding insurance issuers that will 

permit CCIIO to exercise its direct 

enforcement authority over non-Federal 

governmental health plans, investigate 

any inquiries or complaints from 

enrollees of those plans, to determine 

which States may not be substantially 

enforcing the Affordable Care Act and 

PHS Act provisions and to determine 

whether complaints that indicate 


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21374 Federal Register / Vol. 76, No. 73 / Friday, April 15, 2011 / Notices 

possible noncompliance with Federal 

law are resolved by the plans. In 

addition, information maintained will 

enable CCIIO to develop aggregate 

reports that will inform CMS and HHS 

about compliance issues. Information in 

this system will also be disclosed to: (1) 

Support regulatory and programmatic 

activities such as investigations and 

reporting activities performed by an 

Agency contractor, consultants, CMS 

grantees, student volunteers, interns and 

other workers who do not have the 

status of Federal employees; (2) assist 

another Federal and/or State agency, 

agency of a State government, or an 

agency established by State law; (3) 

support litigation involving the Agency; 

(4) combat fraud, waste, and abuse in 

certain health benefits programs, and (5) 

assist in a response to a suspected or 

confirmed breach of the security or 

confidentiality of information. We have 

provided background information about 

this new system in the SUPPLEMENTARY

INFORMATION section below. Although 

the Privacy Act requires only that CMS 

provide an opportunity for interested 

persons to comment on the proposed 

routine uses, CMS invites comments on 

all portions of this notice. See ‘‘Effective 

Dates’’ section for information about the 

comment period. 

DATES: Effective Dates: CMS filed a new 

system report with the Chair of the 

House Committee on Government 

Reform and Oversight, the Chair of the 

Senate Committee on Homeland 

Security & Governmental Affairs, and 

the Administrator, Office of Information 

and Regulatory Affairs, Office of 

Management and Budget (OMB) on 

April 11, 2011. To ensure that all parties 

have adequate time in which to 

comment, the new system, including 

routine uses, will become effective 30 

days from the publication of the notice, 

or 40 days from the date it was 

submitted to OMB and Congress, 

whichever is later, unless CMS receives 

comments that require alterations to this 

notice. 

ADDRESSES: The public should address 

comments to: CMS Privacy Officer, 

Division of Information Security and 

Privacy Management, Enterprise 

Architecture and Strategy Group, Office 

of Information Services, CMS, Room 

N1–24–08, 7500 Security Boulevard, 

Baltimore, Maryland 21244–1850. 

Comments received will be available for 

review at this location, by appointment, 

during regular business hours, Monday 

through Friday from 9 a.m.–3 p.m., 

eastern time zone. 

FOR FURTHER INFORMATION CONTACT: Mr. 

Paul Tibbits, Team Leader, Health 

Insurance Assistance Team, Office of 

Consumer Support, Center for 

Consumer Information and Insurance 

Oversight, Centers for Medicare and 

Medicaid Services, 7500 Security 

Boulevard, Baltimore, Maryland 21244. 

His telephone number is 301–492–4229 

or via e-mail at paul.tibbits@hhs.gov. 

SUPPLEMENTARY INFORMATION: CCIIO has 

direct enforcement authority over nonFederal governmental health plans, and 

any inquiries or complaints from 

enrollees of those plans will be logged 

into this database for the purpose of 

following up to determine whether 

complaints that indicate possible 

noncompliance with Federal law are 

resolved by the plans. In addition, 

consumer inquiries and complaints 

regarding insurance issuers will be 

logged into the database in order to help 

CCIIO determine which States may not 

be substantially enforcing Affordable 

Care Act and PHS Act provisions, and, 

in the event Federal enforcement is 

necessary, in order to follow up to 

determine whether complaints that 

indicate possible noncompliance with 

Federal law are resolved by the issuers. 

Section 1321(c) of the Affordable Care 

Act authorizes HHS (1) to ensure that 

States with Exchanges are substantially 

enforcing the Federal standards to be set 

for the Exchanges and (2) to set up 

Exchanges in States that elect not to do 

so or are not substantially enforcing 

related provisions. Sections 2723 and 

2761 of the PHS Act authorize HHS to 

enforce PHS Act provisions that apply 

to non-Federal governmental plans and 

to enforce PHS Act provisions that 

apply to other health insurance coverage 

in States that HHS has determined are 

not substantially enforcing those 

provisions. 

The database will be maintained by 

the Team to help CCIIO Office of 

Oversight with its compliance activities 

under the Affordable Care Act and PHS 

Act. Consumer inquiries and complaints 

addressed by the Team will help CCIIO 

conduct direct enforcement over nonFederal governmental health plans; the 

database will also help CCIIO determine 

which States are not substantially 

enforcing PHS Act provisions under 

HHS’s Federal fallback authority in 

sections 2723 and 2761 of the PHS Act. 

In the course of its work, the Team 

will: (1) Receive consumer inquiries; (2) 

respond to consumer inquiries in order 

to obtain the necessary information to 

determine the best course of action; (3) 

refer consumers to appropriate entities; 

and (4) when appropriate, gather 

information about consumers in order to 

assist CCIIO oversight capacity. 

When responding to consumer 

contacts, the Team will pursue one of 

the following courses of action: (1) If it 

is determined that the consumer is 

covered by a non-Federal governmental 

plan, the Team will obtain enough 

information to determine whether the 

case merits referral to the Office of 

Oversight; (2) if it is determined that 

jurisdiction over a consumer’s case lies 

with another entity, the Team will refer 

consumers to that entity, such as a State 

insurance department, the U.S. 

Department of Labor, or a State 

Consumer Assistance Program; or (3) if 

it is determined that the consumer seeks 

to file an appeal in a State or territory 

without an external appeals process in 

place, the Team will refer the consumer 

to the appropriate entity carrying out 

the Federal external appeals process. 

As mentioned, the system will be 

used to create reports regarding the 

types of consumer inquiries and 

Affordable Care Act and PHS Act 

compliance issues that are brought to 

the attention of CCIIO by consumers. 

These reports will assist the Office of 

Oversight in identifying areas where 

compliance concerns may arise, and 

will be stripped of any information in 

identifiable form (IIF) and personal 

health information when written and 

prepared. 

I. Description of the Proposed System of 

Records 

A. Statutory and Regulatory Basis for 

System 

Authority for the collection, 

maintenance, and disclosures from this 

system is provided under provisions of 

§§ 2719, 2723, and 2761 of the Public 

Health Service Act (PHS Act) (Pub. L. 

97–35) and § 1321(c) of the Patient 

Protection and Affordable Care Act 

(AFFORABLE CARE ACT) (Pub. L. 

111—148). 

B. Collection and Maintenance of Data 

in the System 

The Health Insurance Assistance 

Database (HIAD) contains information 

on individuals who contact CCIIO’s 

Health Insurance Assistance Team, 

complainants or other individuals with 

health insurance issues. The HIAD 

contains the name, address, State of 

residence and zip code; contact 

information such as telephone numbers, 

e-mail address, demographic 

information such as age, gender, 

ethnicity, family status, employment 

status, income level and veteran’s 

status; and health insurance 

identification number, health insurance 

status, background, recent history and 

available options. 


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II. Agency Policies, Procedures, and 

Restrictions on Routine Uses 

A. The Privacy Act permits us to 

disclose information without an 

individual’s consent if the information 

is to be used for a purpose that is 

compatible with the purpose(s) for 

which the information was collected. 

Any such disclosure of data is known as 

a ‘‘routine use.’’ The government will 

only release information collected in the 

HIAD that can be associated with an 

individual as provided for under 

‘‘Section III. Proposed Routine Use 

Disclosures of Data in the System.’’ 

Identifiable data may be disclosed under 

a routine use. 

CMS has the following policies and 

procedures concerning disclosures of 

information that will be maintained in 

the system. In general, disclosure of 

information from the system will be 

approved only for the minimum 

information necessary to accomplish the 

purpose of the disclosure and only after 

CMS: 

1. Determines that the use or 

disclosure is consistent with the reason 

that the data is being collected, e.g., to 

collect, maintain, and process 

information on consumer inquiries and 

complaints regarding insurance issuers 

that will permit CCIIO to exercise its 

direct enforcement authority over nonFederal governmental health plans, if 

CMS; 

2. Determines that: 

a. the purpose of the disclosure can 

only be accomplished if the record is 

provided in an individually identifiable 

form; 

b. the purpose for which the 

disclosure is to be made is of sufficient 

importance to warrant the effect and/or 

risk on the privacy of the individual 

provider that additional exposure of the 

record might bring; and 

c. there is a strong probability that the 

proposed use of the data would in fact 

accomplish the stated purpose(s). 

3. Requires the information recipient 

to: 

a. establish administrative, technical, 

and physical safeguards to prevent 

unauthorized use of disclosure of the 

record; 

b. remove or destroy at the earliest 

time all individually identifiable 

information; and 

c. agree to not use or disclose the 

information for any purpose other than 

the stated purpose under which the 

information was disclosed. 

4. Determines that the data are valid 

and reliable. 

III. Proposed Routine Use Disclosures 

of Data in the System 

A. Entities Who May Receive Disclosure 

Under Routine Use 

These routine uses specify 

circumstances, in addition to those 

provided by statute in the Privacy Act 

of 1974, under which CMS may release 

information from the HIAD without the 

consent of the individual to whom such 

information pertains. Each proposed 

disclosure of information under these 

routine uses will be evaluated to ensure 

that the disclosure is legally 

permissible, including but not limited to 

ensuring that the purpose of the 

disclosure is compatible with the 

purpose for which the information was 

collected. We propose to establish the 

following routine use disclosures of 

information maintained in the system: 

1. To support Agency contractors, 

consultants, CMS grantees, student 

volunteers, interns and other workers 

who do not have the status of Federal 

employees, and who have been engaged 

by the Agency to assist in 

accomplishment of a CMS function 

relating to the purposes for this SOR 

and who need to have access to the 

records in order to assist CMS. 

We contemplate disclosing 

information under this routine use only 

in situations in which CMS may enter 

into a contractual or similar agreement 

with a third party to assist in 

accomplishing a CMS function relating 

to purposes for this SOR. 

CMS occasionally contracts out 

certain of its functions when doing so 

would contribute to effective and 

efficient operations. CMS must be able 

to give a contractor, consultant, CMS 

grantees, student volunteers, interns and 

other workers who do not have the 

status of Federal employees whatever 

information is necessary for the 

contractor or consultant to fulfill its 

duties. In these situations, safeguards 

are provided in the contract prohibiting 

the contractor, consultant, CMS 

grantees, student volunteers, interns and 

other workers who do not have the 

status of Federal employees from using 

or disclosing the information for any 

purpose other than that described in the 

contract and requires the contractor, 

consultant, CMS grantees, student 

volunteers, interns and other workers 

who do not have the status of Federal 

employees to return or destroy all 

information at the completion of the 

contract. 

2. To assist another Federal or State 

agency, agency of a State government, or 

an agency established by State law 

pursuant to agreements with CMS to: 

a. Increase consumer assistance and 

accessibility to health care coverage by 

identifying insurer noncompliance with 

Federal, State and other applicable law, 

and 

b. Assist Federally funded health 

insurance programs in administering 

functions tasked to them pursuant to the 

Affordable Care Act and other relevant 

Federal and State laws which may 

require CCIIO Program information 

related to this system. 

c. Assist other Federal/State agencies 

that have the authority to perform 

collection of debts owed to the Federal 

government. 

State Departments of Insurance can 

achieve greater regulation and oversight 

of the health insurance industry and 

strengthen enforcement in areas where 

problems arise by identifying trends and 

patterns in consumer inquiries and 

complaints. 

The Internal Revenue Service (IRS), 

Department of the Treasury, can use 

CCIIO information for the purpose of 

resolving difficulties with obtaining 

premium tax credits under 36B of the 

Internal Revenue Code (IRC) of 1986 

and to understand the consumer needs 

leading to the State health insurance 

Exchanges starting in 2014. 

Federal, State, and local law 

enforcement agencies and private 

security contractors, may require CCIIO 

information to protect CCIIO employees 

and customers, provide security for 

CCIIO facilities or to assist 

investigations or prosecutions with 

respect to activities that affect such 

safety and security or activities that 

disrupts the operation of CCIIO 

operations and facilities. 

3. To support the Department of 

Justice (DOJ), court, or adjudicatory 

body when: 

a. the Agency or any component 

thereof, or 

b. any employee of the Agency in his 

or her official capacity, or 

c. any employee of the Agency in his 

or her individual capacity where the 

DOJ has agreed to represent the 

employee, or 

d. the United States Government, 

is a party to litigation or has an interest 

in such litigation, and by careful review, 

HHS determines that the records are 

both relevant and necessary to the 

litigation and that the use of such 

records by the DOJ, court or 

adjudicatory body is compatible with 

the purpose for which the agency 

collected the records. 

Whenever HHS is involved in 

litigation, or occasionally when another 

party is involved in litigation and HHS’s 

policies or operations could be affected 


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21376 Federal Register / Vol. 76, No. 73 / Friday, April 15, 2011 / Notices 

by the outcome of the litigation, HHS 

would be able to disclose information to 

the DOJ, court, or adjudicatory body 

involved. 

4. To assist a CMS contractor 

(including, but not limited to Medicare 

Administrative Contractors, fiscal 

intermediaries, and carriers) that assists 

in the administration of a CMSadministered health benefits program, 

or to a grantee of a CMS-administered 

grant program, when disclosure is 

deemed reasonably necessary by CMS to 

prevent, deter, discover, detect, 

investigate, examine, prosecute, sue 

with respect to, defend against, correct, 

remedy, or otherwise combat fraud, 

waste or abuse in such program. 

We contemplate disclosing 

information under this routine use only 

in situations in which CMS may enter 

into a contract or grant with a third 

party to assist in accomplishing CMS 

functions relating to the purpose of 

combating fraud, waste or abuse. 

CMS occasionally contracts out 

certain of its functions when doing so 

would contribute to effective and 

efficient operations. CMS must be able 

to give a contractor or grantee whatever 

information is necessary for the 

contractor or grantee to fulfill its duties. 

In these situations, safeguards are 

provided in the contract prohibiting the 

contractor or grantee from using or 

disclosing the information for any 

purpose other than that described in the 

contract and requiring the contractor or 

grantee to return or destroy all 

information. 

5. To assist another Federal agency or 

to an instrumentality of any 

governmental jurisdiction within or 

under the control of the United States 

(including any State or local 

governmental agency), that administers, 

or that has the authority to investigate 

potential fraud, waste or abuse in a 

health benefits program funded in 

whole or in part by Federal funds, when 

disclosure is deemed reasonably 

necessary by CMS to prevent, deter, 

discover, detect, investigate, examine, 

prosecute, sue with respect to, defend 

against, correct, remedy, or otherwise 

combat fraud, waste or abuse in such 

programs. 

Other agencies may require CCIIO 

Program information for the purpose of 

combating fraud, waste or abuse in such 

Federally-funded programs. 

6. To assist appropriate Federal 

agencies and Department contractors 

that have a need to know the 

information for the purpose of assisting 

the Department’s efforts to respond to a 

suspected or confirmed breach of the 

security or confidentiality of 

information maintained in this system 

of records, and the information 

disclosed is relevant and unnecessary 

for the assistance. 

Other Federal agencies and 

contractors may require CCIIO Program 

information for the purpose of assisting 

in a respond to a suspected or 

confirmed breach of the security or 

confidentiality of information. 

IV. Safeguards 

CMS has safeguards in place for 

authorized users and monitors such 

users to ensure against unauthorized 

use. Personnel having access to the 

system have been trained in the Privacy 

Act and information security 

requirements. Employees who maintain 

records in this system are instructed not 

to release data until the intended 

recipient agrees to implement 

appropriate management, operational 

and technical safeguards sufficient to 

protect the confidentiality, integrity and 

availability of the information and 

information systems and to prevent 

unauthorized access. 

This system will conform to all 

applicable Federal laws and regulations 

and Federal, HHS, and CMS policies 

and standards as they relate to 

information security and data privacy. 

These laws and regulations include but 

are not limited to: the Privacy Act of 

1974; the Federal Information Security 

Management Act of 2002; the Computer 

Fraud and Abuse Act of 1986; the 

Health Insurance Portability and 

Accountability Act of 1996; the E– 

Government Act of 2002, the ClingerCohen Act of 1996; the Medicare 

Modernization Act of 2003, and the 

corresponding implementing 

regulations. OMB Circular A–130, 

Management of Federal Resources, 

Appendix III, Security of Federal 

Automated Information Resources also 

applies. Federal, HHS, and CMS 

policies and standards include but are 

not limited to: all pertinent National 

Institute of Standards and Technology 

publications; the HHS Information 

Systems Program Handbook and the 

CMS Information Security Handbook. 

V. Effects of the New System on the 

Rights of Individuals 

CMS proposes to establish this system 

in accordance with the principles and 

requirements of the Privacy Act and will 

collect, use, and disseminate 

information only as prescribed therein. 

We will only disclose the minimum 

personal data necessary to achieve the 

purpose of the data collection and the 

routine uses contained in this notice. 

Disclosure of information from the 

system will be approved only to the 

extent necessary to accomplish the 

purpose of the disclosure. CMS has 

assigned a higher level of security 

clearance for the information 

maintained in this system in an effort to 

provide added security and protection 

of data in this system. 

CMS will take precautionary 

measures to minimize the risks of 

unauthorized access to the records and 

the potential harm to individual privacy 

or other personal or property rights. 

CMS will collect only that information 

necessary to perform the system’s 

functions. In addition, CMS will make 

disclosure from the proposed system 

only with consent of the subject 

individual, or his/her legal 

representative, or in accordance with an 

applicable exception provision of the 

Privacy Act. CMS, therefore, does not 

anticipate an unfavorable effect on 

individual privacy as a result of the 

disclosure of information relating to 

individuals. 

Dated: March 18, 2011. 

Steve Larsen, 

Director, Center for Consumer Information 

and Insurance Oversight, Centers for 

Medicare & Medicaid Services. 

SYSTEM NUMBER: 

09–70–0586. 

SYSTEM NAME: 

‘‘Health Insurance Assistance 

Database’’ (HIAD), HHS/CMS/CCIIO. 

SECURITY CLASSIFICATION: 

Level Three Privacy Act Sensitive. 

SYSTEM LOCATION: 

CMS Data Center, 7500 Security 

Boulevard, North Building, First Floor, 

Baltimore, Maryland 21244–1850 and at 

various contractor sites. 

Center for Consumer Information and 

Insurance Oversight, Centers for 

Medicare and Medicaid Services, U.S. 

Department of Health & Human 

Services, Triple-I Core Site, 12100 

Sunrise Valley Drive, Reston, Virginia 

20191. 

CATEGORIES OF INDIVIDUALS COVERED BY THE

SYSTEM: 

Information in this system is 

maintained on individuals who contact 

the CCIIO Health Insurance Assistance 

Team, complainants or other 

individuals with health insurance 

issues. 

CATEGORIES OF RECORDS IN THE SYSTEM: 

The HIAD contains the name, address, 

State of residence and zip code; contact 

information such as telephone numbers, 

e-mail address, demographic 

information such as age, gender, 

ethnicity, family status, employment 

status, income level and veteran’s 


srobinson on DSKHWCL6B1PROD with NOTICES
Federal Register / Vol. 76, No. 73 / Friday, April 15, 2011 / Notices 21377 

status; and health insurance 

identification number, health insurance 

status, background, recent history and 

available options. 

AUTHORITY FOR MAINTENANCE OF THE SYSTEM: 

Authority for the collection, 

maintenance, and disclosures from this 

system is provided under provisions of 

§§ 2719, 2723, and 2761 of the Public 

Health Service Act (PHS Act) (Public 

Law (Pub. L.) 97–35) and § 1321(c) of 

the Patient Protection and Affordable 

Care Act (Affordable Care Act) (Pub. L. 

111–148). 

PURPOSE(S) OF THE SYSTEM: 

The primary purposes of this system 

is to collect and maintain information 

on consumer inquiries and complaints 

regarding insurance issuers that will 

permit CCIIO to exercise its direct 

enforcement authority over non-Federal 

governmental health plans, investigate 

any inquiries or complaints from 

enrollees of those plans, to determine 

which States may not be substantially 

enforcing the Affordable Care Act and 

PHS Act provisions and to determine 

whether complaints that indicate 

possible noncompliance with Federal 

law are resolved by the plans. In 

addition, information maintained will 

enable CCIIO to develop aggregate 

reports that will inform CMS and HHS 

about compliance issues. Information in 

this system will also be disclosed to: (1) 

Support regulatory and programmatic 

activities such as investigations and 

reporting activities performed by an 

Agency contractor, consultants, CMS 

grantees, student volunteers, interns and 

other workers who do not have the 

status of Federal employees; (2) assist 

another Federal and/or State agency, 

agency of a State government, or an 

agency established by State law; (3) 

support litigation involving the Agency; 

(4) combat fraud, waste, and abuse in 

certain health benefits programs, and (5) 

assist in a response to a suspected or 

confirmed breach of the security or 

confidentiality of information. 

I. PROPOSED ROUTINE USES OF RECORDS

MAINTAINED IN THE SYSTEM, INCLUDING

CATEGORIES OR USERS AND THE PURPOSES OF

SUCH USES: 

B. Entities Who May Receive 

Disclosure Under Routine Use 

These routine uses specify 

circumstances, in addition to those 

provided by statute in the Privacy Act 

of 1974, under which CMS may release 

information from the HIAD without the 

consent of the individual to whom such 

information pertains. Each proposed 

disclosure of information under these 

routine uses will be evaluated to ensure 

that the disclosure is legally 

permissible, including but not limited to 

ensuring that the purpose of the 

disclosure is compatible with the 

purpose for which the information was 

collected. We propose to establish the 

following routine use disclosures of 

information maintained in the system: 

3. To support Agency contractors, 

consultants, CMS grantees, student, 

volunteers, interns and other workers 

who do not have the status of Federal 

employees, who have been engaged by 

the Agency to assist in accomplishment 

of a CMS function relating to the 

purposes for this SOR and who need to 

have access to the records in order to 

assist CMS. 

4. To assist another Federal or State 

agency, agency of a State government, or 

an agency established by State law 

pursuant to agreements with CMS to: 

a. Increase consumer assistance and 

accessibility to health care coverage by 

identifying insurer noncompliance with 

Federal, State and other applicable law, 

and 

b. Assist Federally funded health 

insurance programs in administering 

functions tasked to them pursuant to the 

Affordable Care Act and other relevant 

Federal and State laws which may 

require CCIIO Program information 

related to this system. 

c. Assist other Federal/State agencies 

that have the authority to perform 

collection of debts owed to the Federal 

government. 

5. To support the Department of 

Justice (DOJ), court, or adjudicatory 

body when: 

e. The Agency or any component 

thereof, or 

f. Any employee of the Agency in his 

or her official capacity, or 

g. Any employee of the Agency in his 

or her individual capacity where the 

DOJ has agreed to represent the 

employee, or 

h. The United States Government, 

is a party to litigation or has an 

interest in such litigation, and by careful 

review, CMS determines that the 

records are both relevant and necessary 

to the litigation and that the use of such 

records by the DOJ, court or 

adjudicatory body is compatible with 

the purpose for which the agency 

collected the records. 

6. To assist a CMS contractor 

(including, but not limited to Medicare 

Administrative Contractors, fiscal 

intermediaries, and carriers) that assists 

in the administration of a CMSadministered health benefits program, 

or to a grantee of a CMS-administered 

grant program, when disclosure is 

deemed reasonably necessary by CMS to 

prevent, deter, discover, detect, 

investigate, examine, prosecute, sue 

with respect to, defend against, correct, 

remedy, or otherwise combat fraud, 

waste or abuse in such program. 

7. To assist another Federal agency or 

to an instrumentality of any 

governmental jurisdiction within or 

under the control of the United States 

(including any State or local 

governmental agency), that administers, 

or that has the authority to investigate 

potential fraud, waste or abuse in a 

health benefits program funded in 

whole or in part by Federal funds, when 

disclosure is deemed reasonably 

necessary by CMS to prevent, deter, 

discover, detect, investigate, examine, 

prosecute, sue with respect to, defend 

against, correct, remedy, or otherwise 

combat fraud, waste or abuse in such 

programs. 

8. To assist appropriate Federal 

agencies and Department contractors 

that have a need to know the 

information for the purpose of assisting 

the Department’s efforts to respond to a 

suspected or confirmed breach of the 

security or confidentiality of 

information maintained in this system 

of records, and the information 

disclosed is relevant and unnecessary 

for the assistance. 

II. SAFEGUARDS: 

CMS has safeguards in place for 

authorized users and monitors such 

users to ensure against unauthorized 

use. Personnel having access to the 

system have been trained in the Privacy 

Act and information security 

requirements. Employees who maintain 

records in this system are instructed not 

to release data until the intended 

recipient agrees to implement 

appropriate management, operational 

and technical safeguards sufficient to 

protect the confidentiality, integrity and 

availability of the information and 

information systems and to prevent 

unauthorized access. 

This system will conform to all 

applicable Federal laws and regulations 

and Federal, HHS, and CMS policies 

and standards as they relate to 

information security and data privacy. 

These laws and regulations include but 

are not limited to: The Privacy Act of 

1974; the Federal Information Security 

Management Act of 2002; the Computer 

Fraud and Abuse Act of 1986; the 

Health Insurance Portability and 

Accountability Act of 1996; the EGovernment Act of 2002, the ClingerCohen Act of 1996; the Medicare 

Modernization Act of 2003, and the 

corresponding implementing 

regulations. OMB Circular A–130, 

Management of Federal Resources, 

Appendix III, Security of Federal 

Automated Information Resources also 


srobinson on DSKHWCL6B1PROD with NOTICES
21378 Federal Register / Vol. 76, No. 73 / Friday, April 15, 2011 / Notices 

applies. Federal, HHS, and CMS 

policies and standards include but are 

not limited to: all pertinent National 

Institute of Standards and Technology 

publications; the HHS Information 

Systems Program Handbook and the 

CMS Information Security Handbook. 

POLICIES AND PRACTICES FOR STORING, 

RETRIEVING, ACCESSING, RETAINING, AND

DISPOSING OF RECORDS IN THE SYSTEM: 

STORAGE: 

Records are maintained electronically 

in the CCIIO developed database for 

collection, tracking and storage of 

casework information and for reporting 

purposes. Any manually maintained 

records will be kept in locked cabinets 

or otherwise secured areas. 

RETRIEVABILITY: 

The records are retrieved 

electronically by a variety of fields, 

including but not limited to name, State, 

zip code, and health insurance 

identification number issued to the 

individual. 

RETENTION AND DISPOSAL: 

Records are maintained with 

identifiers for all transactions after they 

are entered into the system for a period 

of 10 years. Records are housed in both 

active and archival files. All claimsrelated records are encompassed by the 

document preservation order and will 

be retained until notification is received 

from the Department of Justice. 

SYSTEM MANAGER(S) AND ADDRESS: 

Team Lead, Health Insurance 

Assistance Team, Office of Consumer 

Support, Center for Consumer 

Information and Insurance Oversight, 

Centers for Medicare and Medicaid 

Services, 7500 Security Boulevard, 

Baltimore, Maryland 21244. 

NOTIFICATION PROCEDURE: 

For purpose of notification, the 

subject individual should write to the 

system manager who will require the 

system name and the retrieval selection 

criteria (e.g., name, health insurance 

claim number, SSN, etc.). 

RECORD ACCESS PROCEDURE: 

For purpose of access, use the same 

procedures outlined in Notification 

Procedures above. Requestors should 

also reasonably specify the record 

contents being sought. (These 

procedures are in accordance with 

Department regulation 45 CFR 

5b.5(a)(2)). 

CONTESTING RECORD PROCEDURES: 

The subject individual should contact 

the system manager named above, and 

reasonably identify the record and 

specify the information to be contested. 

State the corrective action sought and 

the reasons for the correction with 

supporting justification. (These 

procedures are in accordance with 

Department regulation 45 CFR 5b.7). 

RECORD SOURCE CATEGORIES: 

The identifying information contained 

in these records is provided voluntarily 

by the individual consumers, 

confidential informants, or by reports 

received from other sources . Additional 

case-relevant information may also be 

provided by the individual’s employer 

or insurer to assist in achieving 

resolution of the specific case. 

SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS

OF THE ACT: 

None. 

[FR Doc. 2011–9105 Filed 4–14–11; 8:45 am] 

BILLING CODE 4120–03–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0264] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Request for 

Designation as Country Not Subject to 

the Restrictions Applicable to Human 

Food and Cosmetics Manufactured 

From, Processed With, or Otherwise 

Containing, Material From Cattle 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing an 

opportunity for public comment on the 

proposed collection of certain 

information by the Agency. Under the 

Paperwork Reduction Act of 1995 (the 

PRA), Federal Agencies are required to 

publish notice in the Federal Register 

concerning each proposed collection of 

information, including each proposed 

extension of an existing collection of 

information, and to allow 60 days for 

public comment in response to the 

notice. This notice solicits comments on 

the information collection provisions of 

existing FDA regulations regarding 

countries seeking to be designated as 

not subject to certain bovine spongiform 

encephalopathy (BSE)-related 

restrictions applicable to FDA-regulated 

human food and cosmetics. 

DATES: Submit either electronic or 

written comments on the collection of 

information by June 14, 2011. 

ADDRESSES: Submit electronic 

comments on the collection of 

information to http:// 

www.regulations.gov. Submit written 

comments on the collection of 

information to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. All 

comments should be identified with the 

docket number found in brackets in the 

heading of this document. 

FOR FURTHER INFORMATION CONTACT: 

Denver Presley, Jr., Office of Information 

Management, Food and Drug 

Administration, 1350 Piccard Dr., PI50– 

400B, Rockville, MD 20850, 301–796– 

3793. 

SUPPLEMENTARY INFORMATION: Under the 

PRA (44 U.S.C. 3501–3520), Federal 

Agencies must obtain approval from the 

Office of Management and Budget 

(OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined in 

44 U.S.C. 3502(3) and 5 CFR 1320.3(c) 

and includes Agency requests or 

requirements that members of the public 

submit reports, keep records, or provide 

information to a third party. Section 

3506(c)(2)(A) of the PRA (44 U.S.C. 

3506(c)(2)(A)) requires Federal Agencies 

to provide a 60-day notice in the 

Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, FDA invites 

comments on these topics: (1) Whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology. 


srobinson on DSKHWCL6B1PROD with NOTICES