Federal Register / Vol. 63, No. 152 / Friday, August 7, 1998 / Notices 42409

1 62 FR 9435 (March 3, 1997) for clinical

laboratories and 63 FR 8987 (February 23, 1998) for

hospitals. The guidances can also be found on the

OIG web site at http:/www.dhhs.gov/progorg/oig.

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

[Document Identifier: HCFA–R–246]

Agency Information Collection

Activities: Proposed Collection;

Comment Request

In compliance with the requirement

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

Paperwork Reduction Act of 1995, the

Health Care Financing Administration

(HCFA), 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 the 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.

Type of Information Request:

Extension of Currently Approved

Collection.

Title of Information Collection: HEDIS

3.0 (Health Plan Data and Information

Set) CAHPS (Consumer Assessment of

Health Plans Study) Survey and

Supporting Regulations 42 CFR 417.470,

417.126.

Form Number: HCFAR–246 (OMB

approval #: 0938–0732).

Use: This collection effort (CAHPS)

will be used to hold the Medicare

managed care industry accountable for

the quality of care they are delivering.

This requirement will allow HCFA to

obtain the information necessary for the

proper oversight of the program. It is

critical to HCFA’s mission that we

collect and disseminate information that

will help beneficiaries choose among

plans, contribute to the improved

quality of care through identification of

quality improvement opportunities, and

assist HCFA in carrying out its

responsibilities.

Frequency: Annually.

Affected Public: Businesses or other

for profit, Individuals or Households.

Number of Respondents: 150,240.

Total Annual Responses: 150,240.

Total Annual Hours Requested:

49,579

To obtain copies of the supporting

statement for the proposed paperwork

collections referenced above, E-mail

your request, including your address

and phone number, to

Paperwork@hcfa.gov, or call the Reports

Clearance Office on (410) 786–1326.

Written comments and

recommendations for the proposed

information collections must be mailed

within 60 days of this notice directly to

the HCFA Paperwork Clearance Officer

designated at the following address:

HCFA, Office of Information Services,

Security and Standards Group, Division

of HCFA Enterprise Standards,

Attention: John Rudolph, Room N2–14–

26 7500, Security Boulevard, Baltimore,

Maryland 21244–1850.

Dated: July 27, 1998.

John P. Burke III,

HCFA Reports Clearance Officer, Division of

HCFA Enterprise Standards, Security and

Standards Group, Health Care Financing

Administration.

[FR Doc. 98–21109 Filed 8–6–98; 8:45 am]

BILLING CODE 4120–03–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Office of Inspector General

Solicitation of Information and

Recommendations for Developing OIG

Compliance Program Guidance for the

Durable Medical Equipment Industry

AGENCY: Office of Inspector General

(OIG), HHS.

ACTION: Notice.

SUMMARY: This Federal Register notice

seeks the input and recommendations of

interested parties into the OIG’s

development of a compliance program

guidance for the durable medical

equipment (DME) industry, its providers

and suppliers. Many providers and

provider organizations have expressed

an interest in better protecting their

operations from fraud and abuse.

Previously, the OIG has developed

compliance program guidances for

hospitals, clinical laboratories and home

health agencies. In order to provide

clear and meaningful guidance to those

segments of the health care industry

involved in the supply and distribution

of DME, we are soliciting comments,

recommendations and other suggestions

from concerned parties and

organizations on how best to develop

compliance program guidance and

reduce fraud and abuse within the DME

industry.

DATES: To assure consideration,

comments must be delivered to the

address provided below by no later than

5 p.m. on September 21, 1998.

ADDRESSES: Please mail or deliver your

written comments, recommendations

and suggestions to the following

address:

Office of Inspector General,

Department of Health and Human

Services, Attention: OIG–3–CPG, Room

5246, Cohen Building, 330

Independence Avenue, SW,

Washington, DC 20201.

We do not accept comments by

facsimile (FAX) transmission. In

commenting, please refer to file code

OIG–3–CPG. Comments received timely

will be available for public inspection as

they are received, generally beginning

approximately 3 weeks after publication

of a document, in Room 5541 of the

Office of Inspector General at 330

Independence Avenue, SW,

Washington, DC, on Monday through

Friday of each week from 8:00 a.m. to

4:30 p.m.

FOR FURTHER INFORMATION CONTACT:

Christine Saxonis, Office of Counsel to

the Inspector General, (202) 619–2078,

or Joel Schaer, Office of Counsel to the

Inspector General, (202) 619–0089.

SUPPLEMENTARY INFORMATION: The

creation of compliance program

guidance has become a major initiative

of the OIG in its effort to engage the

private health care community in

addressing and fighting fraud and abuse.

Recently, the OIG has developed and

issued compliance program guidance

directed at various segments of the

health care industry.1 This guidance is

designed to provide clear direction and

assistance to specific sections of the

health care industry that are interested

in reducing and eliminating fraud and

abuse within their organizations.

The guidances represent the OIG’s

suggestions on how providers can best

establish internal controls and

monitoring to correct and prevent

fraudulent activities. The contents of the

guidances should not be viewed as

mandatory for providers or as an

exclusive discussion of the advisable

elements of a compliance program.

In an effort to formalize the process by

which the OIG receives public

comments in connection with

compliance program guidances, we are

seeking, through this Federal Register

notice, formal input from all interested

parties as the OIG begins developing

compliance program guidance directed

at the DME industry, its providers and

suppliers. The OIG will give

consideration to all comments,

recommendations and suggestions
42410 Federal Register / Vol. 63, No. 152 / Friday, August 7, 1998 / Notices

1The term ‘‘home health agency’’ is applied in

this document as defined in section 1861(o) of the

Social Security Act, 42 U.S.C. 1395x(o).

2This Compliance Program Guidance for Home

Health Agencies is not intended to address issues

specific to suppliers of durable medical equipment,

infusion therapy, and other services typically

provided in the home setting.

submitted and received by the time

frame indicated above.

We anticipate that the DME guidance

will contain the seven elements that we

consider necessary for a comprehensive

compliance program. These seven

elements have been discussed in our

previous guidances and include:

• The development of written

policies and procedures;

• The designation of a compliance

officer and other appropriate bodies;

• The development and

implementation of effective training and

education;

• The development and maintenance

of effective lines of communication;

• The enforcement of standards

through well-publicized disciplinary

guidelines;

• The use of audits and other

evaluation techniques to monitor

compliance; and

• The development of procedures to

respond to detected offenses and to

initiate corrective action.

We would appreciate specific

comments, recommendations and

suggestions on (1) risk areas for the DME

industry, and (2) aspects of the seven

elements contained in previous

guidances that may need to be modified

to reflect the unique characteristics of

the DME industry. Detailed

justifications and empirical data

supporting suggestions would be

appreciated. We are also hopeful that

any comments, recommendations and

input be submitted in a format that

addresses the above topics in a concise

manner, rather than in the form of

comprehensive draft guidance that

mirrors previous guidance.

Dated: July 28, 1998.

June Gibbs Brown,

Inspector General.

[FR Doc. 98–20965 Filed 8–6–98; 8:45 am]

BILLING CODE 4150–04–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Office of Inspector General

Publication of the OIG Compliance

Program Guidance for Home Health

Agencies

AGENCY: Office of Inspector General

(OIG), HHS.

ACTION: Notice.

SUMMARY: This Federal Register notice

sets forth the recently issued

Compliance Program Guidance for

Home Health Agencies developed by the

Office of Inspector General (OIG) in

cooperation with, and with input from,

several provider groups and industry

representatives. Many home health care

providers have expressed interest in

better protecting their operations from

fraud and abuse through the adoption of

a voluntary compliance program. The

OIG has previously developed and

published compliance program

guidances focused on the clinical

laboratory and hospital industries (62

FR 9435, March 3, 1997 and 63 FR 8987,

February 23, 1998, respectively). We

believe that the development of this

compliance program guidance for the

home health industry will continue as a

positive step towards promoting a

higher level of ethical and lawful

conduct throughout the entire health

care community.

FOR FURTHER INFORMATION CONTACT:

Michael Shaw, Office of Counsel to the

Inspector General, (202) 619–2078.

SUPPLEMENTARY INFORMATION: The

creation of compliance program

guidances has become a major initiative

of the OIG in its efforts to engage the

health care community in combating

fraud and abuse. In formulating

compliance guidances, the OIG has

worked closely with the Health Care

Financing Administration, the

Department of Justice and various

sectors of the health care industry to

provide clear guidance to those

segments of the industry that are

interested in reducing fraud and abuse

within their organizations. The first of

these compliance program guidances

focused on clinical laboratories and was

published in the Federal Register on

March 3, 1997 (62 FR 9435). Building on

basic elements of the first issuance, the

second compliance program guidance

developed by the OIG focused on the

hospital industry and was published in

the Federal Register on February 23,

1998 (63 FR 8987). The development of

these types of compliance program

guidance is based on our belief that a

health care provider can use internal

controls to more efficiently monitor

adherence to applicable statutes,

regulations and program requirements.

The OIG has identified seven

fundamental elements to an effective

compliance program. They are:

• Implementing written policies,

procedures and standards of conduct;

• Designating a compliance officer

and compliance committee;

• Conducting effective training and

education;

• Developing effective lines of

communication;

• Enforcing standards through wellpublicized disciplinary guidelines;

• Conducting internal monitoring and

auditing; and

• Responding promptly to detected

offenses and developing corrective

action.

Using these seven basic elements, the

OIG has identified specific areas of

home health operations that, based on

prior Government enforcement efforts,

have proven to be vulnerable to fraud

and abuse. The development of this

Compliance Program Guidance for

Home Health Agencies has been further

enhanced by input from various home

health trade associations and others

with expertise in the home health

industry. Regardless of a home health

agency’s size and structure—whether

large or small, urban or rural, for-profit

or non-profit—the OIG believes that

every home health agency can and

should strive to accomplish the

objectives and principles underlying all

of the compliance policies and

procedures set forth in this

accompanying guidance. Like the

previously-issued compliance guidances

for hospitals and clinical laboratories,

adoption of the Compliance Program

Guidance for Home Health Agencies set

forth below will be voluntary.

A reprint of the OIG’s Compliance

Program Guidance for Home Health

Agencies follows.

Office of Inspector General’s

Compliance Program Guidance for

Home Health Agencies

I. Introduction

The Office of Inspector General (OIG)

of the Department of Health and Human

Services (HHS) continues in its efforts to

promote voluntarily developed and

implemented compliance programs for

the health care industry. The following

compliance program guidance is

intended to assist home health

agencies 1 and their agents and

subproviders (referred to collectively in

this document as ‘‘home health

agencies’’) develop effective internal

controls that promote adherence to

applicable Federal and State law, and

the program requirements of Federal,

State, and private health plans.2 The

adoption and implementation of

voluntary compliance programs

significantly advance the prevention of

fraud, abuse, and waste in these health

care plans while at the same time

further the fundamental mission of all