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comprehensive draft guidance that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
Federal Register / Vol. 63, No. 152 / Friday, August 7, 1998 / Notices 42411

3Recent case law suggests that the failure of a

corporate Director to attempt in good faith to

institute a compliance program in certain situations

may be a breach of a Director’s fiduciary obligation.

See, e.g., In re Caremark International Inc.

Derivative Litigation, 698 A.2d 959 (Ct. Chanc. Del.

1996).

4Current Health Care Financing Administration

(HCFA) reimbursement principles provide that

certain of the costs associated with the creation of

a voluntarily established compliance program may

be allowable costs on certain types of home health

agencies’ cost reports. These allowable costs, of

course, must at a minimum be reasonable and

related to patient care. See generally 42 U.S.C.

1395x(v)(1)(A) (definition of reasonable cost); 42

CFR 413.9(a), (b)(2) (costs related to patent care). In

contract, cost specifically associated with the

implementation of a corporate integrity agreement

in response to a Government investigation resulting

in a civil or criminal judgment or settlement are

unallowable, and are also made specifically and

expressly unallowable in corporate integrity

agreements and civil fraud settlements.

5The OIG, for example, will consider the

existence of an effective compliance program that

pre-dated any governmental investigation when

addressing the appropriateness of administrative

sanctions. The burden is on the provider to

demonstrate the operational effectiveness of a

compliance program. Further, the False Claims Act,

31 U.S.C. 3729–3733, provides that a person who

Continued

home health agencies, which is to

provide quality care to patients.

Within this document, the OIG first

provides its general views on the value

and fundamental principles of home

health agency compliance programs,

and then provides the specific elements

that each home health agency should

consider when developing and

implementing an effective compliance

program. While this document presents

basic procedural and structural

guidance for designing a compliance

program, it is not in itself a compliance

program. Rather, it is a set of guidelines

to be considered by a home health

agency interested in implementing a

compliance program.

The OIG recognizes the sizedifferential that exists between

operations of the different home health

agencies and organizations that

compose the home health industry.

Appropriately, this guidance is

pertinent for all home health agencies,

whether for-profit or non-profit, large or

small, urban or rural. The applicability

of the recommendations and guidelines

provided in this document depends on

the circumstances of each particular

home health agency. However,

regardless of a home health agency’s

size and structure, 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 recommended within this

guidance.

Fundamentally, compliance efforts

are designed to establish a culture

within a home health agency that

promotes prevention, detection, and

resolution of instances of conduct that

do not conform to Federal and State

law, and Federal, State, and private

payor health care program requirements,

as well as the home health agency’s

business policies. In practice, the

compliance program should effectively

articulate and demonstrate the

organization’s commitment to ethical

conduct. The existence of benchmarks

that demonstrate implementation and

achievements are essential to any

effective compliance program.

Eventually, a compliance program

should become part of the fabric of

routine home health agency operations.

Specifically, compliance programs

guide a home health agency’s governing

body (e.g., Board of Directors or

Trustees), Chief Executive Officer

(CEO), managers, clinicians, billing

personnel, and other employees in the

efficient management and operation of a

home health agency. They are especially

critical as an internal control in the

reimbursement and payment areas,

where claims and billing operations are

often the source of fraud and abuse, and

therefore, historically have been the

focus of Government regulation,

scrutiny, and sanctions.

It is incumbent upon a home health

agency’s corporate officers and

managers to provide ethical leadership

to the organization and to assure that

adequate systems are in place to

facilitate ethical and legal conduct.

Employees, managers, and the

Government will focus on the words

and actions of a home health agency’s

leadership as a measure of the

organization’s commitment to

compliance. Indeed, many home health

agencies have adopted mission

statements articulating their

commitment to high ethical standards.

A formal compliance program, as an

additional element in this process,

offers a home health agency a further

concrete method that may improve

quality of care and reduce waste.

Compliance programs also provide a

central coordinating mechanism for

furnishing and disseminating

information and guidance on applicable

Federal and State statutes, regulations,

and other requirements.

Implementing an effective compliance

program requires a substantial

commitment of time, energy, and

resources by senior management and the

home health agency’s governing body.3

Superficial programs that simply

purport to comply with the elements

discussed and described in this

guidance or programs that are hastily

constructed and implemented without

appropriate ongoing monitoring will

likely be ineffective and could expose

the home health agency to greater

liability than no program at all. While

it may require significant additional

resources or reallocation of existing

resources to implement an effective

compliance program, the OIG believes

that the long term benefits of

implementing the program outweigh the

costs.4

A. Benefits of a Compliance Program

In addition to fulfilling its legal duty

to ensure that it is not submitting false

or inaccurate claims to Government and

private payors, a home health agency

may gain numerous additional benefits

by voluntarily implementing an

effective compliance program. Such

programs make good business sense

because they help a home health agency

fulfill its fundamental care-giving

mission to patients and the community,

and assist home health agencies in

identifying weaknesses in internal

systems and management. Other

important potential benefits include the

ability to:

• Concretely demonstrate to

employees and the community at large

the home health agency’s strong

commitment to honest and responsible

provider and corporate conduct;

• Provide a more accurate view of

employee and contractor behavior

relating to fraud and abuse;

• Identify and prevent illegal and

unethical conduct;

• Tailor a compliance program to a

home health agency’s specific needs;

• Improve the quality, efficiency, and

consistency of patient care;

• Create a centralized source for

distributing information on health care

statutes, regulations, and other program

directives related to fraud and abuse

and related issues;

• Formulate a methodology that

encourages employees to report

potential problems;

• Develop procedures that allow the

prompt, thorough investigation of

alleged misconduct by corporate

officers, managers, employees,

independent contractors, consultants,

nurses, and other health care

professionals;

• Initiate immediate, appropriate, and

decisive corrective action;

• Minimize, through early detection

and reporting, the loss to the

Government from false claims, and

thereby reduce the home health

agency’s exposure to civil damages and

penalties, criminal sanctions, and

administrative remedies, such as

program exclusion; 5 and
42412 Federal Register / Vol. 63, No. 152 / Friday, August 7, 1998 / Notices

has violated the Act, but who voluntarily discloses

the violation to the Government, in certain

circumstances will be subject to not less than

double, as opposed to treble, damages. See 31

U.S.C. 3729(a).

6Nothing stated within this document should be

substituted for, or used in lieu of, competent legal

advice from counsel.

7See 63 FR. 8987 (1998) for the Compliance

Program Guidance for Hospitals. See 62 FR 9435

(1997) for the clinical laboratory compliance

program guidance. These documents are also

located on the Internet at http://www.dhhs.gov/

progorg/oig.

8Corporate integrity agreements are executed as

part of a civil settlement between the health care

provider and the Government to resolve a case

based on allegations of health care fraud or abuse.

These OIG-imposed programs are in effect for a

period of 3 to 5 years and require many of the

elements included in this compliance program

guidance.

9This is particularly true in the context of the

home health industry, which includes many small

independent home health agencies with limited

financial resources and staff, as well as the larger

multi-home health agency organizations and

networks with extensive financial resources and

staff.

10See United States Sentencing Commission

Guidelines, Guidelines Manual, 8A1.2, Application

Note 3(k). The Federal Sentencing Guidelines are

detailed policies and practices for the Federal

criminal justice system that prescribe the

appropriate sanctions for offenders convicted of

Federal crimes.

• Enhance the structure of home

health agency operations and gain

consistency between separate business

units.

Overall, the OIG believes that an

effective compliance program is a sound

investment on the part of a home health

agency.

The OIG recognizes that the

implementation of a compliance

program may not entirely eliminate

fraud, abuse, and waste from the home

health agency system. However, a

sincere effort by home health agencies

to comply with applicable Federal and

State standards, as well as the

requirements of private health care

programs, through the establishment of

an effective compliance program,

significantly reduces the risk of

unlawful or improper conduct.

B. Application of Compliance Program

Guidance

Given the diversity within the

industry, there is no single ‘‘best’’ home

health agency compliance program. The

OIG understands the variances and

complexities within the home health

industry and is sensitive to the

differences among large national and

regional multi-home health agency

organizations, specialty home health

agencies, small independent home

health agencies, and other types of

home health agency organizations and

systems. However, elements of this

guidance can be used by all home health

agencies, regardless of size, location, or

corporate structure, to establish an

effective compliance program.

Similarly, a hospital or corporation that

owns a home health agency or provides

home health services may incorporate

these elements into its system-wide

compliance or managerial structure. We

recognize that some home health

agencies may not be able to adopt

certain elements to the same

comprehensive degree that others with

more extensive resources may achieve.

This guidance represents the OIG’s

suggestions on how a home health

agency can best establish internal

controls and monitoring to correct and

prevent fraudulent activities. By no

means should the contents of this

guidance be viewed as an exclusive

discussion of the advisable elements of

a compliance program.

The OIG believes that input and

support by representatives of the major

home health trade associations is

critical to the development and success

of this compliance program guidance.

Therefore, in drafting this guidance, the

OIG received and considered input from

various home health and medical

associations, as well as professional

practice organizations. Further, we took

into consideration previous OIG

publications, such as Special Fraud

Alerts, the recent findings and

recommendations in reports issued by

OIG’s Office of Audit Services and

Office of Evaluation and Inspections, as

well as the experience of past and recent

fraud investigations related to home

health agencies conducted by OIG’s

Office of Investigations and the

Department of Justice. As appropriate,

this guidance may be modified and

expanded as more information and

knowledge is obtained by the OIG, and

as changes in the law, rules, policies,

and procedures of the Federal, State,

and private health plans occur. New

compliance practices may eventually be

incorporated into this guidance if the

OIG discovers significant enhancements

to better ensure an effective compliance

program.

The OIG recognizes that the

development and implementation of

compliance programs in home health

agencies often raise sensitive and

complex legal and managerial issues.6

However, the OIG wishes to offer what

it believes is critical guidance for

providers who are sincerely attempting

to comply with the relevant health care

statutes and regulations.

II. Compliance Program Elements

The elements proposed by these

guidelines are similar to those of the

Compliance Program Guidance for

Hospitals that was published by the OIG

in February 1998, the clinical laboratory

compliance program guidance

published by the OIG in February 1997,7

and our corporate integrity agreements.8

The elements represent a guide that can

be tailored to fit the needs and financial

realities of a particular home health

agency.9 The OIG is cognizant that, with

regard to compliance programs, one

model is not suitable to every home

health agency. Nonetheless, the OIG

believes that every home health agency,

regardless of size or structure, can

benefit from the principles espoused in

this guidance.

The OIG believes that every effective

compliance program must begin with a

formal commitment by the home health

agency’s governing body to include all

of the applicable elements listed below.

These elements are based on the seven

steps of the Federal Sentencing

Guidelines.10 Further, we believe that

every home health agency can

implement most of our recommended

elements that expand upon the seven

steps of the Federal Sentencing

Guidelines. We recognize that full

implementation of all elements may not

be immediately feasible for all home

health agencies. However, as a first step,

a good faith and meaningful

commitment on the part of the home

health agency administration, especially

the governing body and the CEO, will

substantially contribute to a program’s

successful implementation. As the

compliance program is implemented,

that commitment should cascade down

through the management of the home

health agency to every employee at all

levels in the organization.

At a minimum, comprehensive

compliance programs should include

the following seven elements:

(1) The development and distribution

of written standards of conduct, as well

as written policies and procedures that

promote the home health agency’s

commitment to compliance (e.g., by

including adherence to the compliance

program as an element in evaluating

managers and employees) and address

specific areas of potential fraud, such as

claims development and submission

processes, cost reporting, and financial

relationships with physicians and other

health care professionals and entities;

(2) The designation of a compliance

officer and other appropriate bodies,

e.g., a corporate compliance committee,

charged with the responsibility for

operating and monitoring the

compliance program, and who reports
Federal Register / Vol. 63, No. 152 / Friday, August 7, 1998 / Notices 42413

11The integral functions of a compliance officer

and a corporate compliance committee in

implementing an effective compliance program are

discussed throughout this compliance program

guidance. However, the OIG recognizes that a home

health agency may tailor the structure of those

positions in consideration of the size and design of

the home health agency, while endeavoring to

address and accomplish all of the underlying

objectives of a compliance officer and a corporate

compliance committee.

12The term ‘‘Federal health care programs’’ is

applied in this document as defined in 42 U.S.C.

1320a–7b(f), which includes any plan or program

that provides health benefits, whether directly,

through insurance, or otherwise, which is funded

directly, in whole or in part, by the United States

Government (i.e., via programs such as Medicare,

Federal Employees’ Compensation Act, Black Lund,

or the Longshore and Harbor Worker’s

Compensation Act) or any State health plan (e.g.,

Medicaid, or a program receiving funds from block

grants for social services or child health services).

Also, for the purposes of this document, the term

‘‘Federal health care program requirements’’ refers

to the statutes, regulations, rules, requirements,

directive, and instructions governing Medicare,

Medicaid, and all other Federal health care

programs.

13According to the Federal Sentencing

Guidelines, an organization must have established

compliance standards and procedures to be

followed by its employees and other agents in order

to receive sentencing credit for an ‘‘effective’’

compliance program. The Federal Sentencing

Guidelines define ‘‘agent’’ as ‘‘any individual,

including a director, an officer, an employee, or an

independent contractor, authorized to act on behalf

of the organization.’’ See United States Sentencing

Commission Guidelines, Guidelines Manual, 8A1.2,

Application Note 3.

14The OIG strongly encourages high-level

involvement by the home health agency’s governing

body, chief executive officer, chief operating officer,

general counsel, and chief financial officer, as well

as other medical or clinical personnel, as

appropriate, in the development of standards of

conduct. Such involvement should help

communicate a strong and explicit statement of

compliance goals and standards.

15E.g., pharmacies, other home health agencies,

and supplemental staffing entities.

16The OIG recognizes that not all standards,

policies, and procedures need to be communicated

to all employees. However, the OIG believes that

the bulk of the standards that relate to complying

with fraud and abuse laws and other ethical areas

should be addressed and made part of all affected

employees’ training. The home health agency must

decide which additional educational programs

should be limited to the different levels of

employees, based on job functions and areas of

responsibility.

17A home health agency can conduct focus

groups composed of managers from various

departments to solicit their concerns and ideas

about compliance risks that may be incorporated

into the home health agency’s policies and

procedures. Such employee participation in the

development of the home health agency’s

compliance program can enhance its credibility and

foster employee acceptance of the program.

18The OIG periodically issues Special Fraud

Alerts setting forth activities believed to raise legal

and enforcement issues. Home health agency

compliance programs should require that the legal

staff, compliance officer, or other appropriate

personnel carefully consider any and all Special

Fraud Alerts issued by the OIG that relate to home

health agencies. Moreover, the compliance

programs should address the ramifications of failing

to cease and correct any conduct criticized in such

a special Fraud Alert, if applicable to home health

agencies, or to take reasonable action to prevent

such conduct from reoccurring in the future. If

appropriate, a home health agency should take the

steps described in section G.2. regarding

investigations, reporting, and correction of

identified problems.

19The OIG’s work plan is currently available on

the Internet at http://www.dhhs.gov/progorg/oig.

Continued

directly to the CEO and the governing

body; 11

(3) The development and

implementation of regular, effective

education and training programs for all

affected employees;

(4) The creation and maintenance of

a process, such as a hotline or other

reporting system, to receive complaints,

and the adoption of procedures to

protect the anonymity of complainants

and to protect whistleblowers from

retaliation;

(5) The development of a system to

respond to allegations of improper/

illegal activities and the enforcement of

appropriate disciplinary action against

employees who have violated internal

compliance policies, applicable statutes,

regulations, or Federal health care

program requirements; 12

(6) The use of audits and/or other

evaluation techniques to monitor

compliance and assist in the reduction

of identified problem areas;

(7) The investigation and remediation

of identified systemic problems and the

development of policies addressing the

non-employment or retention of

sanctioned individuals.

A. Written Policies and Procedures

Every compliance program should

require the development and

distribution of written compliance

policies, standards, and practices that

identify specific areas of risk and

vulnerability to the home health agency.

These policies, standards, and practices

should be developed under the

direction and supervision of, or subject

to review by, the compliance officer and

compliance committee and, at a

minimum, should be provided to all

individuals who are affected by the

particular policy at issue, including the

home health agency’s agents and

independent contractors.13 In addition

to these general corporate policies, it

may be necessary to implement

individual policies for independent

components of the home health agency.

1. Standards of Conduct

Home health agencies should develop

standards of conduct for all affected

employees that include a clearly

delineated commitment to compliance

by the home health agency’s senior

management 14 and its divisions,

including affiliated providers operating

under the home health agency’s 15

control and other health care

professionals (e.g., physical therapists,

occupational therapists, speech

therapists, and medical social workers).

Standards should articulate the home

health agency’s commitment to comply

with all Federal and State standards,

with an emphasis on preventing fraud

and abuse. They should explicitly state

the organization’s mission, goals, and

ethical requirements of compliance and

reflect a carefully crafted, clear

expression of expectations for all home

health agency governing body members,

officers, managers, employees,

clinicians, and, where appropriate,

contractors and other agents. Standards

should be distributed to, and

comprehensible by, all affected

employees (e.g., translated into other

languages when necessary and written

at appropriate reading levels). Standards

should not only address compliance

with statutes and regulations, but

should also set forth broad principles

that guide employees in conducting

business professionally and properly.

Further, to assist in ensuring that

employees continuously meet the

expected high standards set forth in the

code of conduct, any employee

handbook delineating or expanding

upon these standards of conduct should

be regularly updated as applicable

statutes, regulations, and Federal health

care program requirements are modified

and/or clarified.16

When they first begin working for the

home health agency, and each time new

standards of conduct are issued,

employees should be asked to sign a

statement certifying that they have

received, read, and understood the

standards of conduct. An employee’s

certification should be retained by the

home health agency in the employee’s

personnel file, and available for review

by the compliance officer.

2. Risk Areas

The OIG believes that a home health

agency’s written policies and

procedures should take into

consideration the particular statutes,

rules, and program instructions that

apply to each function or department of

the home health agency.17

Consequently, we recommend that the

individual policies and procedures be

coordinated with the appropriate

training and educational programs with

an emphasis on areas of special concern

that have been identified by the OIG

through its investigative and audit

functions.18 Some of the special areas of

OIG concern include: 19
42414 Federal Register / Vol. 63, No. 152 / Friday, August 7, 1998 / Notices

The OIG Work Plan details the various projects of

the Office of Audit Services, Office of Evaluation

and Inspections, Office of Investigations, and Office

of Counsel to the Inspector General that are planned

to be addressed during each Fiscal Year.

20Billing for services not actually rendered

involves submitting a claim that represents the

provider performed a service all or part of which

was simply not performed. This form of billing

fraud occurs in many health care entities, including

home health agencies, hospitals, laboratories, and

nursing homes, and represents a significant part of

the OIG’s investigative caseload.

21Billing for medically unnecessary services

involves knowingly seeking reimbursement for a

service that is not warranted by the patient’s current

and documented medical condition. See 42 U.S.C.

§ 1395y(a)(1)(A) (‘‘no payment may be made under

part A or part B [of Medicare] for any expenses

incurred for items or services which * * * are not

reasonable and necessary for the diagnosis or

treatment of illness or injury or to improve the

functioning of the malformed body member’’).

Upon submission of an HCFA claim form (whether

paper or electronic), a home health agency certifies

that the services provided and billed were

medically necessary for the health of the

beneficiary, and were rendered in accordance with

orders prescribed by the beneficiary’s physician.

See also discussion in section II.A.3.a and

accompanying notes.

22 Duplicate billing occurs when the home health

agency submits more than one claim for the same

service or the bill is submitted to more than one

primary payor at the same time. Although duplicate

billing can occur due to simple error, knowing,

duplicate billing—which is sometimes evidenced

by systematic or repeated double billing—can create

liability under criminal, civil, or administrative

law, particularly if any overpayment is not

promptly refunded.

23The submission of false cost reports is usually

limited to certain Medicare Part A providers, such

as home health agencies, hospitals, and skilled

nursing facilities, which are reimbursed in part on

the basis of their self-reported operating costs. The

OIG is aware of practices in which home health

agencies maintain records that indicate salaries are

paid to employees that do not exist, lump

nonpatient-related expenses with patient-related

ones in an attempt to bury the non-reimbursable

costs, bill Medicare for patient visits with no

records to substantiate that the services were

performed, inappropriately shift certain costs to

cost centers that are below their reimbursement cap,

shift non-Medicare related costs to Medicare cost

centers, and fail to properly disclose related

organizations (see 42 CFR 413.17(b)), e.g., entities

that provide leased space or equipment, financial

management consulting, and direct patient services

and supplies.

24A credit balance is an improper or excess

payment made to a health care provider as a result

of patient billing or claims processing errors.

Examples of Medicare credit balances include

instances where a provider is: (1) Paid twice for the

same service either by Medicare or by Medicare and

another insurer; or (2) paid for services planned but

not performed or for non-covered services. See

Home Health Agency Manual § 489. Home health

agencies should institute procedures to provide for

the timely and accurate reporting of Medicare and

other Federal health care program credit balances.

25Examples of arrangements that may run afoul

of the anti-kickback statute include practices in

which a home health agency pays a fee to a

physician for each plan of care certified, provides

items or services for free or below fair market value

to beneficiaries of Federal health care programs,

provides nursing or administrative services for free

or below fair market value to physicians, hospitals

and other potential referral sources, and provides

salaries to a referring physician for services either

not rendered or in excess of fair market value for

services rendered. See 42 U.S.C. 1320a–7b; 60 FR

40, 847 (1995). See also discussion in section II.A.4.

and accompanying notes.

26Equally troubling to the OIG is the proliferation

of business arrangements that may violate the antikickback statute. Such arrangements are generally

established between those in a position to refer

business, such as physicians, and those providing

items or services for which a Federal health care

program pays. Sometimes established as ‘‘joint

ventures,’’ these arrangements may take a variety of

forms. The OIG currently has a number of

investigations and audits underway that focus on

such areas of concern.

27Under the Stark physician self-referral law, if

a physician (or an immediate family member of

such physician) has a financial relationship with a

home health agency, the physician may not make

a referral to the home health agency for the

furnishing of home health services for which

payment may be made under the Federal health

care programs. See 42 U.S.C. 1395nn.

28See discussion in section II.A.3.b. and

accompanying notes.

29See discussion in section II.A.3.d. and

accompanying notes.

30Physicians often rely on home health agencies

to determine the need, type, and frequency of home

health services provided to a beneficiary. Since

Medicare does not limit the number of visits or the

length of home health coverage for an individual

beneficiary, home health agencies have incentives

to furnish as many visits as possible, which can

lead to over-utilization. Although it is a physician

that determines medical necessity, a home health

agency has an obligation to ensure that services it

provides are medically necessary, and should

consult with physicians as appropriate for the

requisite assurances.

31 In other words, knowing denial of needed care

in order to keep costs low.

32Home health coordination is intended to

manage and facilitate the transfer of patients from

a hospital or skilled nursing facility to the care of

a home health agency. Although some costs of

performing this service may be allowable under

Medicare, the costs of services performed by home

health agency personnel that constitute patient

solicitation or activities duplicative of an

institution’s discharge planning responsibilities are

not allowable. These non-reimbursable activities, as

well as the allowable costs of performing home

health coordination, are more specifically described

in the Provider Reimbursement Manual, Part I,

§ 2113. Further, the OIG’s Home Health Fraud Alert

of June 1995 specifically warned home health

agencies that providing hospitals with discharge

planners, home health coordinators, or home care

liaisons in order to induce referrals can constitute

a kickback.

33See discussion in section II.A.3.c. and

accompanying notes.

34Home health agencies should not utilize

prohibited or inappropriate conduct (e.g., offer free

gifts or services to patients) to carry out their

initiatives and activities designed to maximize

business growth and patient retention. Also, any

marketing information offered by home health

agencies should be clear, correct, non-deceptive,

and fully informative.

35The current nature of the home health benefit

(i.e., no limits on reimbursable home health visits

in a cost-reimbursed system) and customary

business pressures create risks associated with

incentives (e.g., payments benefits, etc.) for

productivity and volume of services. Such risks

include over-utilization and billing for services not

provided in order to meet internal goals and budget

benchmarks imposed by home health agency

management.

36Under the Medicare conditions of

participation, a home health agency has the duty to

fully inform a beneficiary in advance of termination

of services when further care or treatment is

necessary. See generally 42 U.S.C. 395bbb.

Moreover, State licensure statutes and regulations

may stipulate additional requirements (e.g., the

minimum time period of advance notice allowed)

that home health agencies must follow when

• Billing for items or services not

actually rendered; 20

• Billing for medically unnecessary

services; 21

• Duplicate billing; 22

• False cost reports; 23

• Credit balances—failure to

refund; 24

• Home health agency incentives to

actual or potential referral sources (e.g.,

physicians, hospitals, patients, etc.) that

may violate the anti-kickback statute or

other similar Federal or State statute or

regulation; 25

• Joint ventures between parties, one

of whom can refer Medicare or

Medicaid business to the other; 26

• Stark physician self-referral law; 27

• Billing for services provided to

patients who are not confined to their

residence (or ‘‘homebound’’); 28

• Billing for visits to patients who do

not require a qualifying service; 29

• Over-utilization 30 and underutilization; 31

• Knowing billing for inadequate or

substandard care;

• Insufficient documentation to

evidence that services were performed

and to support reimbursement;

• Billing for unallowable costs of

home health coordination; 32

• Billing for services provided by

unqualified or unlicensed clinical

personnel;

• False dating of amendments to

nursing notes;

• Falsified plans of care; 33

• Untimely and/or forged physician

certifications on plans of care;

• Forged beneficiary signatures on

visit slips/logs that verify services were

performed;

• Improper patient solicitation

activities and high-pressure marketing

of uncovered or unnecessary services; 34

• Inadequate management and

oversight of subcontracted services,

which results in improper billing;

• Discriminatory admission and

discharge of patients;

• Billing for unallowable costs

associated with the acquisition and sale

of home health agencies;

• Compensation programs that offer

incentives for number of visits

performed and revenue generated; 35

• Improper influence over referrals by

hospitals that own home health

agencies;

• Patient abandonment in violation of

applicable statutes, regulations, and

Federal health care program

requirements; 36
Federal Register / Vol. 63, No. 152 / Friday, August 7, 1998 / Notices 42415

terminating the services provided to a patient. The

risk of abandonment may arise when a home health

agency attempts to keep costs of providing services

low.

37According to Medicare reimbursement

principles, where a family member or other person

is or will be providing services that adequately meet

a patient’s needs, it is not reasonable and necessary

for a home health agency to furnish such services.

Therefore, if a home health agency has first hand

knowledge of an able and willing person to provide

the services being rendered by the home health

agency, or a patient (or patient’s family) objects to

a home health agency providing such services, the

home health agency should neither provide nor bill

for such services. See Home Health Agency Manual

§ 203.2.

38See 42 U.S.C. 1395bbb for the Medicare

conditions of participation that apply to home

health agencies.

39 ‘‘Recurrence of misconduct similar to that

which an organization has previously committed

casts doubt on whether it took all reasonable steps

to prevent such misconduct’’ and is a significant

factor in the assessment of whether a compliance

program is effective. See United States Sentencing

Commission Guidelines, Guidelines Manual. 8A1.2,

Application Note 3(k)(iii).

40The OIG recommends that, at a minimum, a

valid statistical sample of claims should be

reviewed before and after billing is submitted.

41E.g., plan of care is dated and signed by a

physician, beneficiary is homebound, skilled

service is required, finite and predictable endpoint

exists and is documented for skilled nursing

services is excess of 35 hours of per week, etc. 42

U.S.C. 1395m(x); 42 CFR 424.22; Home Health

Agency Manual § 204.

42The official reimbursement coverage guidelines

for participating providers in the Medicare program

are promulgated by HCFA in the Provider

Reimbursement Manual and the Home Health

Agency Manual. Generally, to qualify for the home

health benefit covered by Medicare, individuals

must be confined to their residences (be

‘‘homebound’’), be under a physician’s care, and

need part-time or intermittent skilled nursing care

and/or physical or speech therapy. See Home

Health Agency Manual § 204 entitled ‘‘Conditions

the Patient Must Need to Qualify for Coverage of

Home Health Services.’’

43The OIG undertaken numerous audits,

investigations, inspections, and national

enforcement initiatives aimed at reducing potential

and actual fraud, abuse, and waste. For example,

OIG audit reports, which have focused on issues

such as home health agency billing for services not

authorized by a physician, not medically necessary,

not eligible for reimbursement, not rendered, and

for unallowable general and administrative costs,

continue to reveal abusive, wasteful or fraudulent

behavior by some home health agencies. Our report

on the practices of problem providers, our

Operation Restore Trust Audit Report of July 1997,

and our special fraud alert on home health fraud,

illustrate how certain home health agency billing

and business practices may result in fraudulent and

abusive behavior.

• Knowing misuse of provider

certification numbers, which results in

improper billing;

• Duplication of services provided by

assisted living facilities, hospitals,

clinics, physicians, and other home

health agencies;

• Knowing or reckless disregard of

willing and able caregivers when

providing home health services; 37

• Failure to adhere to home health

agency licensing requirements and

Medicare conditions of participation; 38

and

• Knowing failure to return

overpayments made by Federal health

care programs. A home health agency’s

prior history of noncompliance with

applicable statutes, regulations, and

Federal health care program

requirements may indicate additional

types of risk areas where the home

health agency may be vulnerable and

that may require necessary policy

measures to be taken to prevent

avoidable recurrence.39 Additional risk

areas should be assessed by home health

agencies as well and incorporated into

the written policies and procedures and

training elements developed as part of

their compliance programs.

3. Claim Development and Submission

Process

Of the risk areas identified above,

those pertaining to the claim

development and submission process

have been the frequent subject of

administrative recoveries, as well as

investigations and prosecutions under

the civil False Claims Act and criminal

statutes. Settlement of these cases often

has required the defendants to execute

corporate integrity agreements, in

addition to paying significant civil

damages and/or criminal fines and

penalties. These corporate integrity

agreements have provided the OIG with

a mechanism to specify practices that

help ensure compliance with applicable

Federal and State statutes, and Federal

health care program requirements. The

following recommendations include a

number of provisions from various

corporate integrity agreements. As

previously discussed, each home health

agency should develop its own specific

policies tailored to fit its individual

needs.

With respect to the reimbursement

process, a home health agency’s written

policies and procedures should reflect

and reinforce current Federal health

care requirements regarding the

submission of claims and Medicare cost

reports. The policies must create a

mechanism for the billing or

reimbursement staff to communicate

effectively and accurately with the

clinical staff. Policies and procedures

should:

• Provide for sufficient and timely

documentation of all nursing and other

home health services, including

subcontracted services, prior to billing

to ensure that only accurate and

properly documented services are

billed;

• Emphasize that a claim should be

submitted only when appropriate

documentation supports the claim and

only when such documentation is

maintained, appropriately organized in

a legible form, and available for audit

and review. The documentation should

record the activity leading to the record

entry, the identity of the individual

providing the service, and any

information needed to support medical

necessity and other applicable

reimbursement coverage criteria. The

home health agency should consult with

its medical director(s), clinical staff,

and/or governing body to establish other

appropriate documentation guidelines;

• Indicate that the diagnosis and

procedure codes for home health

services reported on the reimbursement

claim should be based on the patient’s

medical record and other

documentation, as well as comply with

all applicable official coding rules and

guidelines. Any Health Care Financing

Administration Common Procedure

Coding System (HCPCS), International

Classification of Disease (ICD), Home

Health Agency’s Current Procedural

Terminology (CPT), or revenue code (or

successor codes) used by the billing staff

should accurately describe the service

that was ordered by the physician and

performed by the home health agency.

The documentation necessary for

accurate billing should be available to

billing staff;

• Provide that the compensation for

billing department personnel and billing

consultants should not offer any

financial incentive to submit claims

regardless of whether they meet

applicable coverage criteria for

reimbursement or accurately represent

the services rendered; and

• Establish and maintain a process for

pre-and post-submission review of

claims 40 to ensure that claims

submitted for reimbursement accurately

represent medically necessary services

actually provided, supported by

sufficient documentation, and in

conformity with any applicable

coverage criteria for reimbursement.41

The written policies and procedures

concerning proper billing should reflect

the current reimbursement principles

set forth in applicable regulations 42 and

should be developed in tandem with

private payor and organizational

standards. Particular attention should be

paid to issues associated with medical

necessity, homebound status of

beneficiary, physician certification of

plan of care, and qualifying services to

establish coverage eligibility.43

a. Medical necessity—Reasonable and

necessary services. A home health

agency’s compliance program should

provide that claims should only be
42416 Federal Register / Vol. 63, No. 152 / Friday, August 7, 1998 / Notices

44For Medicare reimbursement purposes, a plan

for furnishing home health services must be

certified by a physician who is a doctor of

medicine, osteopathy, or podiatric medicine, and

who does not have a significant ownership interest

in, or a significant financial or contractual

relationship with, the home health agency. See 42

CFR 424.22.

45Civil monetary penalties and administrative

sanctions, as well as remedies available under

criminal and civil law, including the civil False

Claims Act, may be imposed against any person

who submits a claim for services ‘‘that [the] person

knows or should know are not medically

necessary.’’ See 42 U.S.C. 1320a–7a(a).

46Medicare fiscal intermediaries and carriers

have the authority to require home health agencies,

which furnish items or services under the program,

to submit documentation that substantiates services

are actually provided and medically necessary. See

Medicare Intermediary Manual § 3116.1.B.

47As it applies to private plan requirements, this

compliance function may be delegated to

supervisory personnel with suitable oversight by

the compliance officer.

48A home health agency may consider including

attestations on nursing note forms to be signed by

caregivers for the purpose of reinforcing the

importance of accurate documentation of services

performed and billed.

49Title XVIII of the Social Security Act,

§ 1861(m), 42 U.S.C. 1395×(m), authorizes the

provision of home health services to patients who

are confined to their home (or homebound). In

general, a patient will be considered to be

homebound if the patient has a condition due to an

illness or injury that restricts the patient’s ability to

leave his or her place of residence except with the

aid of supportive devices such as crutches, canes,

wheelchairs, and walkers, or the assistance of

another person or if leaving home is medically

contraindicated. The condition of these patients

should be such that there exists a normal inability

to leave the home and, consequently, leaving home

would require a considerable and taxing effort. See

Home Health Agency Manual § 204.1. HHS plans to

submit a report to Congress by October 1, 1998,

recommending criteria that should be applied, and

the method of applying such criteria, in the

determination of whether an individual is

homebound for Medicare reimbursement purposes.

See Balanced Budget Act of 1997, Pub. L. 105–33,

§ 4614. Any new criteria developed by HHS should

be incorporated into the public applicable policies

and procedures of a home health agency.

50Recent audits, investigations, and studies of

home health agencies have concluded that many

home health agencies have billed Medicare for

services provided to beneficiaries who are not

homebound. See note 43.

51 If a question is raised as to whether a patient

is confined to the home, the home health agency

will be requested to furnish its Medicare fiscal

intermediary with the information necessary to

establish that the patient is homebound. Home

Health Agency Manual § 204.1.

52 42 CFR 424.22(a)(1)(ii).

53These prompts can be in the form of directions

(e.g., ‘‘Consult with the patient and physician as to

the patient’s ability to leave the home.’’) or

questions (e.g., ‘‘Does the patient ever leave the

home, and if so, where does the patient go and how

often? Does the patient require supportive devices

to leave the home?’’).

54See 42 CFR 484.10(a)(1).

55As a condition for payment of home health

services by Medicare, a physician must certify that

a plan for furnishing the services has been

established and is periodically reviewed by a

physician. 42 CFR 424.22(a) and (b); Home Health

Agency Manual § 204.2 If employees of a home

health agency believe that services ordered by a

physician are excessive or otherwise inappropriate,

the home health agency cannot avoid liability for

filing improper claims simply because a physician

submitted for services that the home

health agency has reason to believe are

medically necessary and were ordered

by a physician 44 or other appropriately

licensed individual.

As a preliminary matter, the OIG

recognizes that licensed health care

professionals must be able to order any

services that are appropriate for the

treatment of their patients. However,

Medicare and other Government and

private health care plans will only pay

for those services otherwise covered that

meet appropriate medical necessity

standards (i.e., in the case of Medicare,

‘‘reasonable and necessary’’ services).

Providers may not bill for services that

do not meet the applicable standards.45

The home health agency is in a unique

position to deliver this information to

the health care professionals on its staff

and to the physicians who refer

patients. Upon request, a home health

agency must be able to provide

documentation, such as physician

orders and other patient medical

records, to support the medical

necessity of a service that the home

health agency has provided.46 The

compliance officer should ensure that a

clear, comprehensive summary of the

‘‘medical necessity’’ definitions and

applicable rules of the various

Government and private plans is

prepared, disseminated, and explained

to appropriate home health agency

personnel.47

We recommend that home health

agencies formulate policies and

procedures that include periodic

clinical reviews, both prior and

subsequent to billing for services, as a

means of verifying that patients are

receiving only medically necessary

services. As part of such reviews, home

health agencies should examine the

frequency and duration of the services

they perform to determine, in

consultation with a physician, whether

patients’ medical conditions justify the

number of visits provided and billed.

Home health agencies may choose to

incorporate this clinical review function

into pre-existing quality assurance

mechanisms or any other quality

assurance processes that may become

part of the conditions of participation

for home health agencies.

Additionally, home health agencies

should implement policies and

procedures to verify that beneficiaries

have actually received the appropriate

level and number of services billed. The

OIG believes that a home health agency

has a duty to sufficiently monitor

services its employees provide to

patients for confirmation that all

services were provided as claimed.48 To

satisfy such an objective, home health

agencies may choose to periodically

contact (i.e., via mail, telephone, or in

person) a random sample of patients

and interview the clinical staff involved.

b. Homebound beneficiaries. For a

home health agency to receive

reimbursement for home health services

under either Medicare Part A or Part B,

the beneficiary must be ‘‘confined to the

home.’’ 49 Home health agencies should

create oversight mechanisms to ensure

that the homebound status of a

Medicare beneficiary is verified and the

specific factors qualifying the patient as

homebound are properly documented.50

Any determinative assessment of the

homebound status of a Medicare

beneficiary should be completed prior

to billing Medicare for home health

services provided to the beneficiary.51

As with other conditions for Medicare

coverage, a physician must certify that

the beneficiary was confined to the

home at the time when services were

provided.52

One means by which home health

agencies may verify the homebound

status of a Medicare beneficiary is the

inclusion of written prompts on nursing

note forms. These prompts can direct

the home health agency’s clinicians

(e.g., registered nurse or licensed

practical nurse) to adequately assess and

document the homebound status of a

Medicare beneficiary based upon

clinical expertise, consultation with the

beneficiary, and orders of the attending

physician.53 Carefully designed prompts

on nursing note forms may help ensure

the complete and appropriate

documentation necessary to substantiate

the homebound status of a Medicare

beneficiary for reimbursement purposes.

Home health agencies can further

ensure compliance with the homebound

requirement by distributing written

notices to Medicare beneficiaries,

reminding them that they must satisfy

the regulatory requirements for

homebound status to be eligible for

Medicare coverage. Since the Medicare

conditions of participation require home

health agencies to give all beneficiaries

a written notice of their legal rights

before furnishing them with home

health services, providers can include

reminders of homebound requirements

in these notices.54

c. Physician certification of the plan

of care. A home health agency should

take all reasonable steps to ensure that

claims for home health services are

ordered and authorized by a

physician.55 The home health agency’s
Federal Register / Vol. 63, No. 152 / Friday, August 7, 1998 / Notices 42417

has ordered the services. Medicare, through

certifications that are incorporated into the claim

forms (paper or electronic) and ratified by home

health agencies upon submission, imposes a duty

to investigate the truth, accuracy, and completeness

of claims before they are submitted. To illustrate,

the HCFA–1500 claim form states that the person

submitting the form certifies ‘‘the services shown

on the[e] form were medically necessary for the

health of the patient.’’

56The Home Health Agency Manual uses the term

‘‘plan of care’’ to refer to the medical treatment plan

established by the treating physician with the

assistance of the home health care nurse. Among

other things, the plan of care must contain all

pertinent diagnoses, including the patient’s mental

status, the types of services, supplies, and

equipment required, the frequency of visits to be

made, prognosis, rehabilitation potential, functional

limitations, activities permitted, nutritional

requirements, and all medications and treatments.

See Home Health Agency Manual § 204.2. The plan

of care is presented in writing on the HCFA–485

form entitled ‘‘Home Health Certification and Plan

of Treatment.’’

57The home health agency should employ

reasonable measures to verify that the physician is

appropriately licensed and no adverse actions, such

as criminal conviction, debarment, or an exclusion,

have been taken against the physician.

58The plan of care must be reviewed and signed

by the physician who established the plan of care,

in consultation with the home health agency

professional personnel, at least every 62 days. Each

review of a patient’s plan of care must contain the

signature of the physician and the date of review.

42 C.F.R. § § 424.22(a), (b); Home Health Agency

Manual § 204.2.F.

59The physician must certify that: (1) The patient

is confined to the home; (2) the patient is in need

of intermittent skilled nursing care, physical

therapy and/or speech therapy or continues to need

occupational therapy; (3) the patient is under the

care of the physician while the services are or were

furnished; and (4) a plan of care has been

established and is periodically reviewed by the

physician. See Home Health Agency Manual § 204.5

and the HCFA–485 form.

60 In practice, home health agencies often accept

the responsibility of assessing a beneficiary’s status

and completing the HCFA–485 plan of care form for

approval by a physician. In the July 1997 OIG Audit

Report (A–04–96–02121) entitled, ‘‘Results of the

Operation Restore Trust Audit of Medicare Home

Health Services in California, Illinois, New York,

and Texas’’ (hereinafter ‘‘OIG ORT Report’’), the

OIG concluded that physicians did not always

review or actively participate in developing the

plans of care they signed, especially for less

complex cases. The report found that physicians

relied heavily on home health agencies to make

determinations as to homebound status, as well as

the need, type, and frequency of home health

services without physician participation. Since

such lack of physician involvement may likely

result in non-covered services, it is advisable that

home health agencies undertake all reasonable

efforts to procure sufficient physician consultation

to ensure that an appropriate plan of care is

established for medically necessary services.

61This can be accomplished through provider

education and liaison activities with physicians and

physician support personnel. See Provider

Reimbursement Manual § 2113.4

62Among other criteria, to receive Medicare

reimbursement for home health services, a

beneficiary must have a need for skilled nursing

care on an intermittent basis, physical therapy,

speech-language pathology services, or a continuing

need for occupational therapy. See Home Health

Agency Manual § 205. To qualify as skilled nursing

services, the services must require the skills of a

registered nurse or a licensed practical (vocational)

nurse under the supervision of a registered nurse,

must be reasonable and necessary to the treatment

of the patient’s illness or injury, and must be

intermittent (as discussed in Home Health Agency

Manual, § 206.7). Where a service can be safely and

effectively performed (or self-administered) by the

average nonmedical person without the direct

supervision of a licensed nurse, the service cannot

be regarded as a skilled service even if a skilled

nurse actually provides the service. Home Health

Agency Manual § 205.1 A.2.

63 If an eligible beneficiary requires a qualifying

service, Medicare also covers visits by home health

aides, medical social workers, and occupational

therapists, as well as medical supplies needed and

used. Hands-on personal care services, such as

bathing, feeding, and assistance with medications,

are services customarily performed by home health

aides in conjunction with a qualifying service.

However, a beneficiary who needs only this type of

personal or custodial care does not qualify for the

home health benefit. Consequently, with no

allowable skilled services, the home health aide

services are also not medically necessary or

reasonable. See Home Health Agency Manual

§ 206.2.

64Recent audits conducted by the OIG have

revealed several instances where home health

agencies have submitted substantial numbers of

claims for home health aide visits to beneficiaries

that did not require any skilled qualifying service.

See OIG ORT Report.

65For administrative, overhead, and other general

costs to be allowable under Medicare, regulations

require that they be reasonable, necessary for the

maintenance of the health care entity, and related

to patient care. 42 CFR 413.9; see also Provider

Reimbursement Manual, Chapter 21.

66E.g., time must be accurately split between

reimbursable home health coordination and nonreimbursable patient solicitation activities (see note

32), and between visits to Medicare beneficiaries

and visits to non-Medicare beneficiaries.

written policies and procedures should

require, at a minimum, that:

• Before the home health agency bills

for services provided to a beneficiary,

the plan of care 56 must be established,

dated, and signed by a qualified

physician; 57

• The plan of care must be

periodically reviewed by a physician in

order for the beneficiary to continue to

qualify for Medicare coverage of home

health benefits; 58

• Home health services are only

billed if the home health agency is

acting upon a physician’s certification

attesting that the services provided to a

patient are medically necessary and

meet the requirements for home health

services to be covered by Medicare; 59

• When consulted, the home health

agency assists the physician in

determining the medical necessity of

home health services and formulating

an appropriate and certified plan of

care; 60

• The home health agency properly

documents any assessment it has made

of a beneficiary’s home health needs,

which may be used by a physician in

developing and authorizing a plan of

care; and

• The home health agency reminds or

educates physicians, as appropriate,

about the scope of their duty to certify

patients for home health services to be

reimbursed by Medicare.61

d. Lack of qualifying service. In

addition to addressing the issues

associated with other reimbursement

coverage criteria, a home health

agency’s policies and procedures should

ensure that all claims satisfy the

requisite need of a qualifying service.62

Since reimbursement coverage of

services by other disciplines may

depend on the need and the provision

of the qualifying service, 63 it is critical

for a home health agency to enlist

measures to prevent billing for

dependent services after any qualifying

service has ceased.64 Any procedures or

practices that a home health agency may

implement in response to this identified

risk will most likely correspond with

other policy measures taken by the

home health agency to ensure medical

necessity.

e. Cost reports. In addition to

submitting claims for specific services,

home health agencies submit annual

cost reports to Medicare for

reimbursement of administrative,

overhead, and other general costs. With

regard to cost report issues, the written

policies should include procedures that

seek to ensure full compliance with

applicable statutes, regulations, and

Federal health care program

requirements. Among other things, the

home health agency’s procedures

should ensure that:

• Costs are not claimed unless they

are reimbursable, reasonable, and are

based on appropriate and accurate

documentation;

• Allocations of costs to various cost

centers are accurately made and

supportable by verifiable and auditable

data;

• Unallowable costs are not claimed

for reimbursement; 65

• Accounts containing both allowable

and unallowable costs are analyzed to

determine the unallowable amount that

should not be claimed for

reimbursement;

• Costs are properly classified; 66

• Medicare fiscal intermediary prior

year audit adjustments are implemented

and are either not claimed for

reimbursement or if claimed for

reimbursement, are clearly identified as

protested amounts on the cost report;

• All related parties are identified on

the cost report and all related party

charges are reduced to the cost to the

related party;

• Allocations from a home health

agency chain’s home office cost

statement to individual home health

agency cost reports are accurately made
42418 Federal Register / Vol. 63, No. 152 / Friday, August 7, 1998 / Notices

67 Individuals who reside in assisted living

facilities may be eligible for Medicare coverage of

home health services. See Home Health Agency

Manual § 204.1B. However, if it is determined that

the services furnished by the home health agency

are duplicative of services furnished by an assisted

living facility, such as when provision of such care

is required of the facility under State licensure

requirements, claims for such services are

unallowable under 42 U.S.C. 1395y(a)(1)(A) and

should not be submitted. Services to people who

already have access to appropriate care from a

willing caregiver would not be considered

reasonable and necessary to the treatment of the

individual’s illness or injury. See Home Health

Agency Manual § 203.2. See also note 37.

68Audits and investigations by both the OIG and

Medicare fiscal intermediaries have revealed

several instances where home health aids of home

health agencies have provided personal care

services, such as meal preparation, room cleaning,

and bathing, to Medicare beneficiaries who reside

in assisted living facilities required by State license

to provide such services. In addition to the

customary liability assumed by a home health

agency for submitting claims for such duplicative

and unallowable services, a home health agency

may violate the anti-kickback statute for providing

these services at no charge to an assisted living

facility, an entity that is responsible to perform the

services and is a potential source of referrals.

69See Balanced Budget Act of 1997, Pub. L. 105–

33, § 4603.

70Towards this end, the home health agency’s inhouse counsel or compliance officer should, among

other things, obtain copies of all relevant OIG

regulations, special fraud alerts, and advisory

opinions (these documents are located on the

Internet at http://www.dhhs.gov/progorg/oig), and

ensure that the home health agency’s policies

reflect the guidance provided by the OIG.

71 In addition to the anti-kickback statutes and the

Stark physician self-referral law provisions, 42 CFR

424.22 expressly prohibits a home health agency

from providing services certified or recertified by

any physician who has a significant ownership

interest in, or a significant financial or contractual

relationship with, that home health agency.

72See 42 U.S.C. 1320a–7b(b); 60 FR 40847 (1995).

73See 42 CFR 1001.952.

74This records system should be tailored to fit the

individual needs and financial resources of the

home health agency.

and supportable by verifiable and

auditable data;

• Management fees are reasonable

and necessary, and do not include

unallowable costs, such as certain

acquisition costs associated with the

purchase of a home health agency (e.g.,

good will, non-competes);

• Any return of overpayments,

including those resulting from an

internal review or audit, are

appropriately reflected in cost reports,

i.e., a repayment of an overpayment

received in a prior year may necessitate

changes or amendments to the cost

report applicable to the prior year; and

• Procedures are in place and

documented for notifying promptly the

Medicare fiscal intermediary (or any

other applicable payor, e.g., TRICARE

(formerly CHAMPUS) and Medicaid) in

writing of errors discovered after the

submission of the home health agency

cost report, and, where applicable, after

the submission of a home health agency

chain’s home office cost statement.

f. Services provided to patients who

reside in assisted living facilities. Home

health agencies should formulate

effective policies and procedures to

evaluate home health services provided

to individuals who reside in assisted

living facilities (also called residential

care facilities, personal care homes,

group homes, etc.) to determine whether

the services are appropriate for

reimbursement.67 To avoid the

submission of improper claims for

services to such individuals, the

adoption of the following measures is

advisable upon a request to provide

home health services to a resident of an

assisted living facility:

• Contact the appropriate State

licensing authority to determine any

applicable State licensure and service

requirements for the specific facility

involved;

• Make reasonable attempts to verify

the specific license, if any, held by the

facility, e.g., view the license certificate

hanging on the facility’s wall;

• Request to view the service

agreement between the facility and the

resident during the initial assessment

visit to determine the extent and type of

the services that the facility is

contractually obligated to provide to the

resident; and

• Provide home health services to the

resident only to the extent that they are

appropriate and not duplicative of those

services provided or required to be

provided by the facility.68

The OIG strongly recommends that a

home health agency contact the

appropriate State licensing authority if

there is reason to believe a Statelicensed facility is failing to provide

care that is required by its licensure,

regardless of whether claims for services

provided to residents of such facilities

would otherwise be reimbursable by

Medicare or another Federal health care

program.

g. Prospective payment system. The

Balanced Budget Act of 1997 provides

for the establishment of a prospective

payment system (PPS) for all costs of

home health services. Upon the

commencement of such system, all

services covered and paid on a

reasonable cost basis under the

Medicare home health benefit,

including medical supplies, will be paid

for on the basis of a computed

prospective payment amount.69 Once

HHS institutes the PPS, home health

agencies should guard against new types

of fraud, abuse, and waste that might

arise in such a reimbursement system.

Potential risks may include failure to

report or mischaracterization of a

change in patient conditions used to

establish the PPS charge, denial of

medically necessary care resulting in

under-utilization, and duplicate billing

of charges subsumed within the PPS

payment. Accordingly, home health

agencies should prepare to implement

policies and procedures to properly

address any potential risk areas

associated with the PPS.

4. Anti-Kickback and Self-Referral

Concerns

The home health agency should have

policies and procedures in place with

respect to compliance with Federal and

State anti-kickback statutes, as well as

the Stark physician self-referral law.70

Such policies should provide that:

• All of the home health agency’s

contracts and arrangements with actual

or potential referral sources are

reviewed by counsel and comply with

all applicable statutes and

regulations; 71

• The home health agency does not

submit or cause to be submitted to the

Federal health care programs claims for

patients who were referred to the home

health agency pursuant to contracts or

financial arrangements that were

designed to induce such referrals in

violation of the anti-kickback statute,

Stark physician self-referral law, or

similar Federal or State statute or

regulation; and

• The home health agency does not

offer or provide gifts, free services, or

other incentives to patients, relatives of

patients, physicians, hospitals,

contractors, assisted living facilities, or

other potential referral sources for the

purpose of inducing referrals in

violation of the anti-kickback statute,

Stark physician self-referral law, or

similar Federal or State statute or

regulation.72

Further, the policies and procedures

should specifically reference and take

into account the OIG’s safe harbor

regulations, which clarify those

payment practices that would be

immune from prosecution under the

anti-kickback statute.73

5. Retention of Records

Home health agency compliance

programs should provide for the

implementation of a records system.

This system should establish policies

and procedures regarding the creation,

distribution, retention, storage, retrieval,

and destruction of documents.74 The

three categories of documents

developed under this system should

include: (1) All records and

documentation (e.g., clinical and
Federal Register / Vol. 63, No. 152 / Friday, August 7, 1998 / Notices 42419

75For example, as a condition of participation,

Medicare requires that home health agencies retain

records regarding their claims to Medicare for a

minimum of 5 years after the month the cost report

to which the records apply is filed with the fiscal

intermediary. See 42 CFR 484.48(a).

76The creation and retention of such documents

and reports may raise a variety of legal issues, such

as patient privacy and confidentiality. These issues

are best discussed with legal counsel.

77The OIG believes that it is not advisable for the

compliance function to be subordinate to the home

health agency’s general counsel, or comptroller or

similar home health agency financial officer. Free

standing compliance functions help to ensure

independent and objective legal reviews and

financial analyses of the institution’s compliance

efforts and activities. By separating the compliance

function from the key management positions of

general counsel or chief financial officer (where the

size and structure of the home health agency make

this a feasible option), a system of checks and

balances is established to more effectively achieve

the goals of the compliance program.

78For multi-home health agency organizations or

hospital-owned home health agencies, the OIG

encourages coordination with each home health

agency owned by the corporation or hospital

through the use of a headquarter’s compliance

officer, communicating with parallel positions in

each facility, regional office, or business line, as

appropriate.

79The National Practitioner Data Bank is a data

base that contains information about medical

malpractice payments, sanctions by boards of

medical examiners or State licensing boards,

adverse clinical privilege actions, and adverse

professional society membership actions. Health

care entities can have access to this data base to

seek information about their own medical or

clinical staff, as well as prospective employees.

80The Cumulative Sanction Report is an OIGproduced report available on the Internet at

http://www.dhhs.gov/progorg/oig. It is updated on

a regular basis to reflect the status of health care

providers who have been excluded from

participation in the Medicare and Medicaid

programs. In addition, the General Services

Administration maintains a monthly listing of

debarred contractors on the Internet at http://

www.arnet.gov/epls.

81The compliance officer may also have to ensure

that the criminal backgrounds of employees have

been checked depending upon State requirements

or home health agency policy. See note 105.

medical records, and billing and claims

documentation) required either by

Federal or State law for participation in

Federal health care programs 75 or any

other applicable Federal and State laws

and regulations (e.g., document

retention requirements to maintain State

licensure); (2) all records,

documentation, and verifiable and

auditable data that support the home

health agency’s Medicare cost report,

and, where applicable, the home health

agency chain’s home office cost

statement; and (3) all records necessary

to protect the integrity of the home

health agency’s compliance process and

confirm the effectiveness of the

program. The third category includes:

documentation that employees were

adequately trained; reports from the

home health agency’s hotline, including

the nature and results of any

investigation that was conducted;

documentation of corrective action,

including disciplinary action taken and

policy improvements introduced, in

response to any internal investigation or

audit; modifications to the compliance

program; self-disclosures; and the

results of the home health agency’s

auditing and monitoring efforts.76

6. Compliance as an Element of a

Performance Plan

Compliance programs should require

that the promotion of, and adherence to,

the elements of the compliance program

be a factor in evaluating the

performance of all employees, who

should be periodically trained in new

compliance policies and procedures. In

addition, all managers and supervisors

involved in the claims and cost report

development and submission processes

should:

• Discuss with all supervised

employees and relevant contractors the

compliance policies and legal

requirements pertinent to their function;

• Inform all supervised personnel

that strict compliance with these

policies and requirements is a condition

of employment; and

• Disclose to all supervised personnel

that the home health agency will take

disciplinary action up to and including

termination for violation of these

policies or requirements.

In addition to making performance of

these duties an element in evaluations,

the compliance officer or home health

agency management should include in

the home health agency’s compliance

program a policy that managers and

supervisors will be sanctioned for

failing to adequately instruct their

subordinates or for failing to detect

noncompliance with applicable policies

and legal requirements, where

reasonable diligence on the part of the

manager or supervisor would have led

to the discovery of any problems or

violations and given the home health

agency the opportunity to correct them

earlier.

B. Designation of a Compliance Officer

and a Compliance Committee

1. Compliance Officer

Every home health agency should

designate a compliance officer to serve

as the focal point for compliance

activities. This responsibility may be the

individual’s sole duty or added to other

management responsibilities, depending

upon the size and resources of the home

health agency and the complexity of the

task. Designating a compliance officer

with the appropriate authority is critical

to the success of the program,

necessitating the appointment of a highlevel official in the home health agency

with direct access to the home health

agency’s president or CEO, governing

body, all other senior management, and

legal counsel.77 The officer should have

sufficient funding and staff to perform

his or her responsibilities fully.

Coordination and communication are

the key functions of the compliance

officer with regard to planning,

implementing, and monitoring the

compliance program.

The compliance officer’s primary

responsibilities should include:

• Overseeing and monitoring the

implementation of the compliance

program; 78

• Reporting on a regular basis to the

home health agency’s governing body,

CEO, and compliance committee (if

applicable) on the progress of

implementation, and assisting these

components in establishing methods to

improve the home health agency’s

efficiency and quality of services, and to

reduce the home health agency’s

vulnerability to fraud, abuse, and waste;

• Periodically revising the program in

light of changes in the organization’s

needs, and in the law and policies and

procedures of Government and private

payor health plans;

• Reviewing employees’ certifications

that they have received, read, and

understood the standards of conduct;

• Developing, coordinating, and

participating in a multifaceted

educational and training program that

focuses on the elements of the

compliance program, and seeks to

ensure that all relevant employees and

management are knowledgeable of, and

comply with, pertinent Federal and

State standards;

• Ensuring that independent

contractors and agents who furnish

nursing or other health care services to

the clients of the home health agency,

or billing services to the home health

agency, are aware of the requirements of

the home health agency’s compliance

program with respect to coverage,

billing, and marketing, among other

things;

• Coordinating personnel issues with

the home health agency’s Human

Resources/Personnel office (or its

equivalent) to ensure that the National

Practitioner Data Bank 79 and

Cumulative Sanction Report 80 have

been checked with respect to all

employees, medical staff, and

independent contractors (as

appropriate); 81

• Assisting the home health agency’s

financial management in coordinating

internal compliance review and
42420 Federal Register / Vol. 63, No. 152 / Friday, August 7, 1998 / Notices

82E.g., physical therapists, occupational

therapists, speech therapists, medical social

workers, and supplemental staffing entities.

83Periodic on-site visits of home agency

operations, bulletins with compliance updates and

reminders, distribution of audiotapes or videotapes

on different risk areas, lectures at management and

employee meetings, circulation of recent health care

article covering fraud and abuse, and innovative

changes to compliance training are various

examples of approaches and techniques the

compliance officer can employ for the purpose of

ensuring continued interest in the compliance

program and the home health agency’s commitment

to its policies and principles.

84The compliance committee benefits from

having the perspectives of individuals with varying

responsibilities in the organization, such as

operations, finance, audit, human resources, and

clinical management (e.g., Medical Director), as

well as employees and managers of key operating

units. These individuals should have the requisite

seniority and comprehensive experience within

their respective departments to implement any

necessary changes to home health agency policies

and procedures as recommended by the committee.

A compliance committee for a home health agency

that is part of a hospital might benefit from the

participation of officials from other departments in

the hospital, such as the accounting and billing

departments.

85A health care provider should expect its

compliance committee members and compliance

officer to demonstrate high integrity, good

judgment, assertiveness, and an approachable

demeanor, while eliciting the respect and trust of

employees of the home health agency and having

significant professional experience working with

billing, clinical records, documentation, and

auditing principles.

86E.g., understanding the practical implications

of the fraud and abuse provisions of the Balanced

Budget Act of 1997, Pub. L. 105–33, and the Health

Insurance Portability and Accountability Act of

1996, Pub. L. 104–191.

87This includes, but is not limited to, compliance

with the Medicare conditions of participation. See

42 U.S.C. 1395bbb.

88With respect to multi-home health agency

organizations and hospital-owned home health

agencies, this may include fostering coordination

and communication between those employees

responsible for compliance at the corporation or

hospital and those responsible for compliance at the

home agencies.

89Specific compliance training should

complement any ‘‘in-service’’ training sessions that

a home health agency may regularly schedule to

reinforce adherence to policies and practices of the

particular home health agency.

monitoring activities, including annual

or periodic reviews of departments;

• Independently investigating and

acting on matters related to compliance,

including the flexibility to design and

coordinate internal investigations (e.g.,

responding to reports of problems or

suspected violations) and any resulting

corrective action (e.g., making necessary

improvements to home health agency

policies and practices, taking

appropriate disciplinary action, etc.)

with all home health agency

departments, subcontracted providers,

and health care professionals under the

home health agency’s control, 82 and

any other agents if appropriate;

• Developing policies and programs

that encourage managers and employees

to report suspected fraud and other

improprieties without fear of retaliation;

and

• Continuing the momentum of the

compliance program and the

accomplishment of its objectives long

after the initial years of

implementation.83

The compliance officer must have the

authority to review all documents and

other information that are relevant to

compliance activities, including, but not

limited to, patient records, billing

records, and records concerning the

marketing efforts of the facility and the

home health agency’s arrangements

with other parties, including employees,

professionals on staff, relevant

independent contractors, suppliers,

agents, supplemental staffing entities,

and physicians. This policy enables the

compliance officer to review contracts

and obligations (seeking the advice of

legal counsel, where appropriate) that

may contain referral and payment

provisions that could violate the antikickback statute, as well as the Stark

physician self-referral prohibition and

other legal or regulatory requirements.

2. Compliance Committee

The OIG recommends that a

compliance committee be established to

advise the compliance officer and assist

in the implementation of the

compliance program.84 When

developing an appropriate team of

people to serve as the home health

agency’s compliance committee,

including the compliance officer, a

home health agency should consider a

variety of skills and personality traits

that are expected from those in such

positions.85 Once a home health agency

chooses the people that will accept the

responsibilities vested in members of

the compliance committee, the home

health agency needs to train these

individuals on the policies and

procedures of the compliance program,

as well as how to discharge their duties.

The committee’s functions should

include:

• Analyzing the organization,86

regulatory environment, the legal

requirements with which it must

comply,87 and specific risk areas;

• Assessing existing policies and

procedures that address these risk areas

for possible incorporation into the

compliance program;

• Working with appropriate home

health agency departments to develop

standards of conduct and policies and

procedures to promote compliance with

legal and ethical requirements;

• Recommending and monitoring, in

conjunction with the relevant

departments, the development of

internal systems and controls to carry

out the organization’s standards,

policies, and procedures as part of its

daily operations; 88

• Determining the appropriate

strategy/approach to promote

compliance with the program and

detection of any potential violations,

such as through hotlines and other fraud

reporting mechanisms;

• Developing a system to solicit,

evaluate, and respond to complaints and

problems; and

• Monitoring internal and external

audits and investigations for the

purpose of identifying troublesome

issues and deficient areas experienced

by the home health agency, and

implementing corrective and preventive

action.

The committee may also address other

functions as the compliance concept

becomes part of the overall home health

agency operating structure and daily

routine.

C. Conducting Effective Training and

Education

The proper education and training of

corporate officers, managers, employees,

nurses, and other health care

professionals, and the continual

retraining of current personnel at all

levels, are significant elements of an

effective compliance program. As part of

their compliance programs, home health

agencies should require personnel to

attend specific training on a periodic

basis, including appropriate training in

Federal and State statutes, regulations,

and guidelines, and the policies of

private payors, and training in corporate

ethics, which emphasizes the

organization’s commitment to

compliance with these legal

requirements and policies.89

These training programs should

include sessions highlighting the

organization’s compliance program,

summarizing fraud and abuse laws,

Federal health care program

requirements, claim development and

submission processes, patient rights,

and marketing practices that reflect

current legal and program standards.

The organization must take steps to

communicate effectively its standards

and procedures to all affected

employees, physicians, independent

contractors, and other significant agents,

e.g., by requiring participation in

training programs and disseminating

publications that explain specific
Federal Register / Vol. 63, No. 152 / Friday, August 7, 1998 / Notices 42421

90Some publications, such as OIG’s Special Fraud

Alerts, audit and inspection reports, and advisory

opinions, as well as the annual OIG work plan, are

readily available from the OIG and could be the

basis for standards, educational courses, and

programs for appropriate home health agency

employees.

91Significant variations in the functions and

responsibilities of different departments or groups

may create the need for training materials that are

tailored to compliance concerns associated with

particular operations and duties.

92Certain positions, such as those that involve the

billing of home health services, create a greater

organizational legal exposure, and therefore require

specialized training. One recommendation would

be for a home health agency to attempt to fill such

positions with individuals who have the

appropriate educational background and training.

93Post-training tests can be used to assess the

success of training provided and employee

comprehension of the home health agency’s

policies and procedures.

94 In addition, where feasible, the OIG

recommends that a home health agency afford

outside contractors the opportunity to participate in

the home health agency’s compliance training and

educational programs, or develop their own

programs that complement the home health

agency’s standards of conduct, compliance

requirements, and other rules and practices.

95Currently, the OIG is monitoring a significant

number of corporate integrity agreements that

require many of these training elements. The OIG

usually requires a minimum of 1 to 3 hours

annually for basic training in compliance areas.

Additional training is required for specialty fields

such as billing and marketing.

96Appropriate billing depends upon the quality

and completeness of the clinical documentation.

Therefore, OIG believes that active clinical staff

participation in educational programs focusing on

billing and documentation should be emphasized

by the home health agency. Clinical staff should be

reminded that thorough, precise, and timely

documentation of services provided services the

interests of the patient, as well as the interests of

the billing department.

97The OIG believes that whistleblowers should be

protected against retaliation, a concept embodied in

the provisions of the False Claims Act. See 31

U.S.C. 3730(h). In many causes, employees sue their

employers under the False Claims Act’s qui tam

provisions out of frustration because of the

company’s failure to take action when a

questionable, fraudulent, or abusive situation was

brought to the attention of senior corporate officials.

98Home health agencies can also consider

rewarding employees for appropriate use of

established systems.

requirements in a practical manner.90

Managers of specific departments or

groups can assist in identifying areas

that require training and in carrying out

such training.91 Training instructors

may come from outside or inside the

organization, but must be qualified to

present the subject matter involved and

experienced enough in the issues

presented to adequately field questions

and coordinate discussions among those

being trained. New employees should be

trained early in their employment.92

Training programs and materials should

be designed to take into account the

skills, experience, and knowledge of the

individual trainees. The compliance

officer should document any formal

training undertaken by the home health

agency as part of the compliance

program.

A variety of teaching methods, such

as interactive training, and training in

several different languages, particularly

where a home health agency has a

culturally diverse staff, should be

implemented so that all affected

employees are knowledgeable of the

institution’s standards of conduct and

procedures for alerting senior

management to problems and

concerns.93 Targeted training should be

provided to corporate officers,

managers, and other employees whose

actions affect the accuracy of the claims

submitted to the Government, such as

employees involved in the billing, cost

reporting, and marketing processes.

Given the complexity and

interdependent relationships of many

departments, proper coordination and

supervision of this process by the

compliance officer is important. In

addition to specific training in the risk

areas identified in section II.A.2, above,

primary training for appropriate

corporate officers, managers, and other

home health agency staff should include

such topics as:

• Government and private payor

reimbursement principles;

• General prohibitions on paying or

receiving remuneration to induce

referrals;

• Improper alterations to clinical

records;

• Providing home health services

with proper authorization;

• Proper documentation of services

rendered, including the correct

application of official ICD and CPT

coding rules and guidelines;

• Patient rights and patient

education;

• Compliance with Medicare

conditions of participation; and

• Duty to report misconduct.

Clarifying and emphasizing these

areas of concern through training and

educational programs are particularly

relevant to a home health agency’s

marketing and financial personnel, in

that the pressure to meet business goals

may render these employees vulnerable

to engaging in prohibited practices.

The OIG suggests that all relevant

levels of personnel be made part of

various educational and training

programs of the home health agency.94

Employees should be required to have a

minimum number of educational hours

per year, as appropriate, as part of their

employment responsibilities.95 For

example, for certain employees involved

in the billing functions, periodic

training in applicable reimbursement

coverage and documentation of clinical

records should be required.96 In home

health agencies with high employee

turnover, periodic training updates are

critical.

The OIG recommends that attendance

and participation in training programs

be made a condition of continued

employment and that failure to comply

with training requirements should result

in disciplinary action, including

possible termination, when such failure

is serious. Adherence to the provisions

of the compliance program, such as

training requirements, should be a factor

in the annual evaluation of each

employee. The home health agency

should retain adequate records of its

training of employees, including

attendance logs and material distributed

at training sessions.

Finally, the OIG recommends that

home health agency compliance

programs address the need for periodic

professional education courses that may

be required by statute and regulation for

certain home health agency employees.

D. Developing Effective Lines of

Communication

1. Access to the Compliance Officer

An open line of communication

between the compliance officer and

home health agency employees is

equally important to the successful

implementation of a compliance

program and the reduction of any

potential for fraud, abuse, and waste.

Written confidentiality and nonretaliation policies should be developed

and distributed to all employees to

encourage communication and the

reporting of incidents of potential

fraud.97 The compliance committee

should also develop independent

reporting paths for an employee to

report fraud, waste, or abuse so that

employees can feel comfortable

reporting outside the normal chain of

command and supervisors or other

personnel cannot divert such reports.98

The OIG encourages the establishment

of a procedure so that home health

agency personnel may seek clarification

from the compliance officer or members

of the compliance committee in the

event of any confusion or question with

regard to a home health agency policy,

practice, or procedure. Questions and

responses should be documented and

dated and, if appropriate, shared with

other staff so that standards, policies,

practices, and procedures can be

updated and improved to reflect any

necessary changes or clarifications. The
42422 Federal Register / Vol. 63, No. 152 / Friday, August 7, 1998 / Notices

99The OIG recognizes that it may not be

financially feasible for a smaller home health

agency to maintain a telephone hotline dedicated to

receiving calls about compliance issues.

100 In addition to methods of communication

used by current employees, an effective employee

exit interview program could be designed to solicit

information from departing employees regarding

potential misconduct and suspected violations go

home health agency policy and procedures.

101Home health agencies should also post in a

prominent, available area the HHS–OIG Hotline

telephone number, 1–800–447–8477 (1–800–HHS–

TIPS), in addition to any company hotline number

that may be posted.

102To efficiently and accurately fulfill such an

obligation, the home health agency should create an

intake form for all compliance issues identified

through reporting mechanisms. The form could

include information concerning the date that the

potential problem was reported, the internal

investigative methods utilized, the results of the

investigation, the corrective action implemented,

the disciplinary measures imposed, and any

identified overpayments and monies returned.

103 Information obtained over the hotline may

provide valuable insight into management practices

and operations, whether reported problems are

actual or perceived.

104See note 80.

105Slightly over a quarter of the States require,

and several home health agencies voluntarily

conduct, criminal background checks for

prospective employees of home health agencies.

Identification of a criminal background of an

applicant, who may have been recently convicted

of serious crimes that relate to the proposed

employment duties, could be grounds for denying

employment. Further, criminal background

screening may deter those individuals with

criminal intent from entering the field of home

health. See United States General Accounting

Office’s September 27, 1996, Letter Report entitled

‘‘Long-Term Care: Some States Apply Criminal

Background Checks to Home Care Workers,’’ GAO/

PEMD–96–5.

106Since providers of home health services have

frequent, relatively unsupervised access to

potentially vulnerable people and their property, a

home health agency should also strictly scrutinize

whether it should employ individuals who have

been convicted of crimes of neglect, violence, or

financial misconduct.

107Likewise, home health agency compliance

programs should establish standards prohibiting the

compliance officer may want to solicit

employee input in developing these

communication and reporting systems.

2. Hotlines and Other Forms of

Communication

The OIG encourages the use of

hotlines,99 e-mails, written memoranda,

newsletters, suggestion boxes, and other

forms of information exchange to

maintain these open lines of

communication.100 If the home health

agency establishes a hotline, the

telephone number should be made

readily available to all employees and

independent contractors, possibly by

circulating the number on wallet cards

or conspicuously posting the telephone

number in common work areas.101

Employees should be permitted to

report matters on an anonymous basis.

Matters reported through the hotline or

other communication sources that

suggest substantial violations of

compliance policies, Federal health care

program requirements, regulations, or

statutes should be documented and

investigated promptly to determine their

veracity. A log should be maintained by

the compliance officer that records such

calls, including the nature of any

investigation and its results.102 Such

information should be included in

reports to the governing body, the CEO,

and compliance committee.103 Further,

while the home health agency should

always strive to maintain the

confidentiality of an employee’s

identity, it should also explicitly

communicate that there may be a point

where the individual’s identity may

become known or may have to be

revealed in certain instances.

The OIG recognizes that assertions of

fraud and abuse by employees who may

have participated in illegal conduct or

committed other malfeasance raise

numerous complex legal and

management issues that should be

examined on a case-by-case basis. The

compliance officer should work closely

with legal counsel, who can provide

guidance regarding such issues.

E. Enforcing Standards Through WellPublicized Disciplinary Guidelines

1. Discipline Policy and Actions

An effective compliance program

should include guidance regarding

disciplinary action for corporate

officers, managers, employees, and other

health care professionals who have

failed to comply with the home health

agency’s standards of conduct, policies

and procedures, Federal health care

program requirements, or Federal and

State laws, or those who have otherwise

engaged in wrongdoing, which have the

potential to impair the home health

agency’s status as a reliable, honest, and

trustworthy health care provider.

The OIG believes that the compliance

program should include a written policy

statement setting forth the degrees of

disciplinary actions that may be

imposed upon corporate officers,

managers, employees, and other health

care professionals for failing to comply

with the home health agency’s

standards and policies and applicable

statutes and regulations. Intentional or

reckless noncompliance should subject

transgressors to significant sanctions.

Such sanctions could range from oral

warnings to suspension, termination, or

financial penalties, as appropriate. Each

situation must be considered on a caseby-case basis to determine the

appropriate sanction. The written

standards of conduct should elaborate

on the procedures for handling

disciplinary problems and those who

will be responsible for taking

appropriate action. Some disciplinary

actions can be handled by department

or agency managers, while others may

have to be resolved by a senior home

health agency administrator.

Disciplinary action may be appropriate

where a responsible employee’s failure

to detect a violation is attributable to his

or her negligence or reckless conduct.

Personnel should be advised by the

home health agency that disciplinary

action will be taken on a fair and

equitable basis. Managers and

supervisors should be made aware that

they have a responsibility to discipline

employees in an appropriate and

consistent manner.

It is vital to publish and disseminate

the range of disciplinary standards for

improper conduct and to educate

officers and other home health agency

employees regarding these standards.

The consequences of noncompliance

should be consistently applied and

enforced, in order for the disciplinary

policy to have the required deterrent

effect. All levels of employees should be

potentially subject to the same types of

disciplinary action for the commission

of similar offenses. The commitment to

compliance applies to all personnel

levels within a home health agency. The

OIG believes that corporate officers,

managers, supervisors, clinical staff, and

other health care professionals should

be held accountable for failing to

comply with, or for the foreseeable

failure of their subordinates to adhere

to, the applicable standards, laws, and

procedures.

2. New Employee Policy

For all new employees who have

discretionary authority to make

decisions that may involve compliance

with the law or compliance oversight,

home health agencies should conduct a

reasonable and prudent background

investigation, including a reference

check,104 as part of every such

employment application. The

application should specifically require

the applicant to disclose any criminal

conviction,105 as defined by 42 U.S.C.

1320a–7(i), or exclusion action.

Pursuant to the compliance program,

home health agency policies should

prohibit the employment of individuals

who have been recently convicted of a

criminal offense related to health

care 106 or who are listed as debarred,

excluded, or otherwise ineligible for

participation in Federal health care

programs.107 In addition, pending the
Federal Register / Vol. 63, No. 152 / Friday, August 7, 1998 / Notices 42423

execution of contracts with companies that have

been recently convicted of a criminal offense

related to health care or that are listed by a Federal

agency as debarred, excluded, or otherwise

ineligible for participation in Federal health care

programs. See note 80.

108Prospective employees who have been

officially reinstated into the Medicare and Medicaid

programs by the OIG may be considered for

employment upon proof of such reinstatement.

109Even when a home health agency or group of

home health agencies is owned by a larger corporate

entity, the regular auditing and monitoring of the

compliance activities of an individual home health

agency must be a key feature in any annual review.

Appropriate reports on audit findings should be

periodically provided and explained to a parent

organization’s senior staff and officers.

110See also section II.A.2.

111The OIG recommends that when a compliance

program is established in a home health agency, the

compliance officer, with the assistance of

department managers, should take a ‘‘snapshot’’ of

their operations from a compliance perspective.

This assessment can be undertaken by outside

consultants, law or accounting firms, or internal

staff, with authoritative knowledge of health care

compliance requirements. This ‘‘snapshot,’’ often

used as part of benchmarking analyses, becomes a

baseline for the compliance officer and other

managers to judge the home health agency’s

progress in reducing or eliminating potential areas

of vulnerability.

112 In addition, when appropriate, as referenced

in section G.2, below, reports of fraud or systemic

problems should also be made to the appropriate

governmental authority.

113One way to assess the knowledge, awareness,

and perceptions of the home health agency’s

employees is through the use of a validated survey

instrument (e.g., employee questionnaires,

interviews, or focus groups).

114Such records should include, but not be

limited to, logs of hotline calls, logs of training

attendees, training agenda materials, and

summaries of corrective action taken and

improvements made to home health agency policies

as a result of compliance activities.

resolution of any criminal charges or

proposed debarment or exclusion, the

OIG recommends that an individual

who is the subject of such actions

should be removed from direct

responsibility for or involvement in any

Federal health care program.108 With

regard to current employees or

independent contractors, if resolution of

the matter results in conviction,

debarment, or exclusion, the home

health agency should terminate its

employment or other contract

arrangement with the individual or

contractor.

F. Auditing and Monitoring

An ongoing evaluation process is

critical to a successful compliance

program. The OIG believes that an

effective program should incorporate

thorough monitoring of its

implementation and regular reporting to

senior home health agency or corporate

officers.109 Compliance reports created

by this ongoing monitoring, including

reports of suspected noncompliance,

should be maintained by the

compliance officer and shared with the

home health agency’s senior

management and the compliance

committee. The extent and frequency of

the audit function may vary depending

on factors such as the size and available

resources, prior history of

noncompliance, and the risk factors that

a particular home health agency

confronts.

Although many monitoring

techniques are available, one effective

tool to promote and ensure compliance

is the performance of regular, periodic

compliance audits by internal or

external auditors who have expertise in

Federal and State health care statutes,

regulations, and Federal health care

program requirements. The audits

should focus on the home health

agency’s programs or divisions,

including external relationships with

third-party contractors, specifically

those with substantive exposure to

Government enforcement actions. At a

minimum, these audits should be

designed to address the home health

agency’s compliance with laws

governing kickback arrangements, the

physician self-referral prohibition, claim

development and submission,

reimbursement, cost reporting, and

marketing. The audits and reviews

should inquire into the home health

agency’s compliance with the Medicare

conditions of participation and the

specific rules and policies that have

been the focus of particular attention on

the part of the Medicare fiscal

intermediaries or carriers, and law

enforcement, as evidenced by

educational and other communications

from OIG Special Fraud Alerts, OIG

audits and evaluations, and law

enforcement’s initiatives.110 In addition,

the home health agency should focus on

any areas of concern that are specific to

the individual home health agency and

have been identified by any entity,

whether Federal, State, or internal.

Monitoring techniques may include

sampling protocols that permit the

compliance officer to identify and

review variations from an established

baseline.111 Significant variations from

the baseline should trigger a reasonable

inquiry to determine the cause of the

deviation. If the inquiry determines that

the deviation occurred for legitimate,

explainable reasons, the compliance

officer and home health agency

management may want to limit any

corrective action or take no action. If it

is determined that the deviation was

caused by improper procedures,

misunderstanding of rules, including

fraud and systemic problems, the home

health agency should take prompt steps

to correct the problem. Any

overpayments discovered as a result of

such deviations should be returned

promptly to the affected payor, with

appropriate documentation and a

sufficiently detailed explanation of the

reason for the refund.112

Monitoring techniques may also

include a review of any reserves the

home health agency has established for

payments that it may owe to Medicare,

Medicaid, or other Federal health care

programs. Any reserves discovered that

include funds that should have been

paid to such programs, or funds set

aside for potential reimbursement of a

known overpayment to the home health

agency, should be paid promptly,

regardless of whether demand has been

made for such payment.

An effective compliance program

should also incorporate periodic (at

least annual) reviews of whether the

program’s compliance elements have

been satisfied, e.g., whether there has

been appropriate dissemination of the

program’s standards, training, ongoing

educational programs, and disciplinary

actions, among other elements.113 This

process will verify actual conformance

by all departments with the compliance

program and may identify the necessity

for improvements to be made to the

compliance program, as well as the

home health agency’s operations. Such

reviews could support a determination

that appropriate records have been

created and maintained to document the

implementation of an effective

program.114 However, when monitoring

discloses that deviations were not

detected in a timely manner due to

program deficiencies, proper

modifications must be implemented.

Such evaluations, when developed with

the support of management, can help

ensure compliance with the home

health agency’s policies and procedures.

As part of the review process, the

compliance officer or reviewers should

consider techniques such as:

• Visits and interviews of patients at

their homes;

• Analysis of utilization patterns;

• Testing clinical and billing staff on

their knowledge of reimbursement

coverage criteria and official coding

guidelines (e.g., present hypothetical

scenarios of situations experienced in

daily practice and assess responses);

• Assessment of existing

relationships with physicians, hospitals,

and other potential referral sources;

• Unannounced mock surveys,

audits, and investigations;

• Reevaluation of deficiencies cited

in past surveys for Medicare conditions

of participation;
42424 Federal Register / Vol. 63, No. 152 / Friday, August 7, 1998 / Notices

115The OIG recognizes that home health agencies

that are small in size and have limited resources

may not be able to use internal reviewers who are

not part of line management or hire outsider

reviewers.

116 Instances of noncompliance must be

determined on a case-by-case basis. The existence,

or amount, of a monetary loss to a health care

program is not solely determinative of whether or

not the conduct should be investigated and reported

to governmental authorities. In fact, there may be

instances where there is no readily identifiable

monetary loss at all, but corrective action and

reporting are still necessary to protect the integrity

of the applicable program and its beneficiaries, (e.g.,

where services required by a plan of care were not

provided.

117Advice from the home health agency’s inhouse counsel or an outside law firm may be sought

to determine the extent of the home health agency’s

liability and to plan the appropriate course of

action.

118The OIG currently maintains a voluntary

disclosure program that encourages providers to

report suspected fraud. The concept of voluntary

self-disclosure is premised on a recognition that the

Government alone cannot protect the integrity of

the Medicare and other Federal health care

programs. Health care providers must be willing to

police themselves, correct underlying problems,

and work with the Government to resolve these

matters. The OIG’s voluntary self-disclosure

program has four prerequisites: (1) The disclosure

must be on behalf of an entity and not an

individual; (2) the disclosure must be truly

voluntary (i.e., no pending proceeding or

investigation); (3) the entity must disclose the

nature of the wrongdoing and the harm to the

Federal health care programs; and (4) the entity

must not be the subject of a bankruptcy proceeding

before or after the self-disclosure.

119The parameters of a claim review subject to an

internal investigation will depend on the

• Examination of home health agency

complaint logs;

• Checking personnel records to

determine whether any individuals who

have been reprimanded for compliance

issues in the past are among those

currently engaged in improper conduct;

• Interviews with personnel involved

in management, operations, claim

development and submission, patient

care, and other related activities;

• Questionnaires developed to solicit

impressions of a broad cross-section of

the home health agency’s employees

and staff;

• Interviews with physicians who

order services provided by the home

health agency;

• Reviews of clinical documentation

(e.g., plan of care, nursing notes, etc.),

financial records, and other source

documents that support claims for

reimbursement and Medicare cost

reports;

• Validation of qualifications of

physicians who order services provided

by the home health agency;

• Evaluation of written materials and

documentation outlining the home

health agency’s policies and procedures;

and

• Trend analyses, or longitudinal

studies, that uncover deviations,

positive or negative, in specific areas

over a given period.

The reviewers should:

• Have the qualifications and

experience necessary to adequately

identify potential issues with the subject

matter that is reviewed;

• Be objective and independent of

line management to the extent

reasonably possible; 115

• Have access to existing audit and

health care resources, relevant

personnel, and all relevant areas of

operation;

• Present written evaluative reports

on compliance activities to the CEO,

governing body, and members of the

compliance committee on a regular

basis, but no less often than annually;

and

• Specifically identify areas where

corrective actions are needed.

With these reports, home health

agency management can take whatever

steps are necessary to correct past

problems and prevent them from

recurring. In certain cases, subsequent

reviews or studies would be advisable to

ensure that the recommended corrective

actions have been implemented

successfully.

The home health agency should

document its efforts to comply with

applicable statutes, regulations, and

Federal health care program

requirements. For example, where a

home health agency, in its efforts to

comply with a particular statute,

regulation or program requirement,

requests advice from a Government

agency (including a Medicare fiscal

intermediary or carrier) charged with

administering a Federal health care

program, the home health agency

should document and retain a record of

the request and any written or oral

response. This step is extremely

important if the home health agency

intends to rely on that response to guide

it in future decisions, actions, or claim

reimbursement requests or appeals. A

log of oral inquiries between the home

health agency and third parties will

help the organization document its

attempts at compliance. In addition, the

home health agency should maintain

records relevant to the issue of whether

its reliance was ‘‘reasonable’’ and

whether it exercised due diligence in

developing procedures and practices to

implement the advice.

G. Responding to Detected Offenses and

Developing Corrective Action Initiatives

1. Violations and Investigations

Violations of a home health agency’s

compliance program, failures to comply

with applicable Federal or State law,

and other types of misconduct threaten

a home health agency’s status as a

reliable, honest and trustworthy

provider capable of participating in

Federal health care programs. Detected

but uncorrected misconduct can

seriously endanger the mission,

reputation, and legal status of the home

health agency. Consequently, upon

reports or reasonable indications of

suspected noncompliance, it is

important that the compliance officer or

other management officials immediately

investigate the conduct in question to

determine whether a material violation

of applicable law or the requirements of

the compliance program has occurred,

and if so, take decisive steps to correct

the problem.116 As appropriate, such

steps may include an immediate referral

to criminal and/or civil law enforcement

authorities, a corrective action plan,117

a report to the Government,118 and the

return of any overpayments, if

applicable.

Where potential fraud or False Claims

Act liability is not involved, the OIG

recommends that normal repayment

channels should be used for returning

overpayments to the Government as

they are discovered. However, even if

the overpayment detection and return

process is working and is being

monitored by the home health agency’s

audit or billing divisions, the OIG still

believes that the compliance officer

needs to be made aware of these

overpayments, violations, or deviations

that may reveal trends or patterns

indicative of a systemic problem.

Depending upon the nature of the

alleged violations, an internal

investigation will probably include

interviews and a review of relevant

documents. Some home health agencies

should consider engaging outside

counsel, auditors, or health care experts

to assist in an investigation.

Records of the investigation should

contain documentation of the alleged

violation, a description of the

investigative process (including the

objectivity of the investigators and

methodologies utilized), copies of

interview notes and key documents, a

log of the witnesses interviewed and the

documents reviewed, the results of the

investigation, e.g., any disciplinary

action taken, and the corrective action

implemented. While any action taken as

the result of an investigation will

necessarily vary depending upon the

home health agency and the situation,

home health agencies should strive for

some consistency by utilizing sound

practices and disciplinary protocols.119
Federal Register / Vol. 63, No. 152 / Friday, August 7, 1998 / Notices 42425

circumstances surrounding the issue(s) identified.

By limiting the scope of an internal audit to current

billing, a home health agency may fail to discover

major problems and deficiencies in operations, as

well as be subject to certain liability.

120Appropriate Federal and State authorities

include the Office of Inspector General of the

Department of Health and Human Services, the

Criminal and Civil Divisions of the Department of

Justice, the U.S. Attorney in relevant districts, and

the other investigative arms for the agencies

administering the affected Federal or State health

care programs, such as the State Medicaid Fraud

Control Unit, the Defense Criminal Investigative

Service, and, the Department of Veterans Affairs

and the Office of Personnel Management (which

administers the Federal Employee Health Benefits

Program).

121 In contrast, to qualify for the ‘‘not less than

double damages’’ provision of the False Claims Act,

the report must be provided to the government

within thirty (30) days after the date when the home

health agency first obtained the information. 31

U.S.C. 3729(a).

122The OIG believes that some violations may be

so serious that they warrant immediate notification

to governmental authorities, prior to, or

simultaneous with, commencing an internal

investigation, e.g., if the conduct: (1) Is a clear

violation of criminal law; (2) has a significant

adverse effect on the quality of care provided to

program beneficiaries (in addition to any other legal

obligations regarding quality of care); or (3)

indicates evidence of a systemic failure to comply

with applicable laws or an existing corporate

integrity agreement, regardless of the financial

impact on Federal health care programs.

123The OIG has published criteria setting forth

those factors that the OIG takes into consideration

in determining whether it is appropriate to exclude

a health care provider from program participation

pursuant to 42 U.S.C. 1320a–7(b)(7) for violations

of various fraud and abuse laws. See 62 FR 67392

(1997).

124See note 120.

125A home health agency should consult with its

Medicare fiscal intermediary or HCFA for any

further guidance regarding normal repayment

channels. The home health agency’s Medicare fiscal

intermediary or HCFA may require certain

information (e.g., alleged violation or issue causing

overpayment, description of the internal

investigative process with methodologies used to

determine any overpayments, disciplinary actions

taken, and corrective actions taken, etc.) To be

submitted with return of any overpayments, and

that such repayment information be submitted to a

specific department or individual. Interest will be

assessed, when appropriate. See 42 CFR 405.376.

126See U.S.C. 130a–7b(a)(3).

Further, after a reasonable period, the

compliance officer should review the

circumstances that formed the basis for

the investigation to determine whether

similar problems have been uncovered

or modifications of the compliance

program are necessary to prevent and

detect other inappropriate conduct or

violations.

If an investigation of an alleged

violation is undertaken and the

compliance officer believes the integrity

of the investigation may be at stake

because of the presence of employees

under investigation, those subjects

should be removed from their current

work activity until the investigation is

completed (unless an internal or

Government-led undercover operation

known to the home health agency is in

effect). In addition, the compliance

officer should take appropriate steps to

secure or prevent the destruction of

documents or other evidence relevant to

the investigation. If the home health

agency determines that disciplinary

action is warranted, it should be prompt

and imposed in accordance with the

home health agency’s written standards

of disciplinary action.

2. Reporting

If the compliance officer, compliance

committee, or management official

discovers credible evidence of

misconduct from any source and, after

a reasonable inquiry, has reason to

believe that the misconduct may violate

criminal, civil, or administrative law,

then the home health agency should

promptly report the existence of

misconduct to the appropriate Federal

and State authorities 120 within a

reasonable period, but not more than

sixty (60) days 121 after determining that

there is credible evidence of a

violation.122 Prompt reporting will

demonstrate the home health agency’s

good faith and willingness to work with

governmental authorities to correct and

remedy the problem. In addition,

reporting such conduct will be

considered a mitigating factor by the

OIG in determining administrative

sanctions (e.g., penalties, assessments,

and exclusion), if the reporting provider

becomes the target of an OIG

investigation.123

When reporting misconduct to the

Government, a home health agency

should provide all evidence relevant to

the alleged violation of applicable

Federal or State law(s) and potential

cost impact. The compliance officer,

under advice of counsel, and with

guidance from the governmental

authorities, could be requested to

continue to investigate the reported

violation. Once the investigation is

completed, the compliance officer

should be required to notify the

appropriate governmental authority of

the outcome of the investigation,

including a description of the impact of

the alleged violation on the operation of

the applicable health care programs or

their beneficiaries. If the investigation

ultimately reveals that criminal, civil, or

administrative violations have occurred,

the appropriate Federal and State

authorities 124 should be notified

immediately.

As previously stated, the home health

agency should take appropriate

corrective action, including prompt

identification of any overpayment to the

affected payor and the imposition of

proper disciplinary action. If potential

fraud or violations of the False Claims

Act are involved, any repayment of the

overpayment should be made as part of

the discussion with the Government

following a report of the matter to law

enforcement authorities. Otherwise,

normal repayment channels should be

used for repaying identified

overpayments.125 Failure to disclose

overpayments within a reasonable

period of time could be interpreted as

an intentional attempt to conceal the

overpayment from the Government,

thereby establishing an independent

basis for a criminal violation with

respect to the home health agency, as

well as any individuals who may have

been involved.126 For this reason, home

health agency compliance programs

should emphasize that overpayments

obtained from Medicare and other

Federal health care programs should be

promptly disclosed and returned to the

payor that made the erroneous payment.

III. Conclusion

Through this document, the OIG has

attempted to provide a foundation to the

process necessary to develop an

effective and cost-efficient home health

agency compliance program. As

previously stated, however, each

program must be tailored to fit the needs

and resources of an individual home

health agency, depending upon its

particular corporate structure, mission,

and employee composition. The

statutes, regulations, and guidelines of

the Federal and State health insurance

programs, as well as the policies and

procedures of the private health plans,

should be integrated into every home

health agency’s compliance program.

The OIG recognizes that the health

care industry in this country, which

reaches millions of beneficiaries and

expends about a trillion dollars

annually, is constantly evolving. In

particular, the home health industry is

currently responding to recent

legislative changes that have created

additional program participation

requirements and is gearing up for the

changes underway in the areas of home

health reimbursement and payment

methodologies. However, the time is

right for home health agencies to

implement a strong voluntary

compliance program concept in health

care. As stated throughout this

guidance, compliance is a dynamic

process that helps to ensure that home

health agencies and other health care

providers are better able to fulfill their

commitment to ethical behavior, as well

as meet the changes and challenges
42426 Federal Register / Vol. 63, No. 152 / Friday, August 7, 1998 / Notices

being imposed upon them by Congress

and private insurers. Ultimately, it is

OIG’s hope that a voluntarily created

compliance program will enable home

health agencies to meet their goals,

improve the quality of patient care, and

substantially reduce fraud, waste, and

abuse, as well as the cost of health care

to Federal, State, and private health

insurers.

Dated: July 31, 1998.

June Gibbs Brown,

Inspector General.

[FR Doc. 98–20966 Filed 8–6–98; 8:45 am]

BILLING CODE 4150–04–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

National Cancer Institute; Notice of

Closed Meeting

Pursuant to section 10(d) of the

Federal Advisory Committee Act, as

amended (5 U.S.C. Appendix 2), notice

is hereby given of the following

meeting.

The meeting will be closed to the

public in accordance with the

provisions set forth in sections

552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,

as amended. The grant applications and

the discussions could disclose

confidential trade secrets or commercial

property such as patentable material,

and personal information concerning

individuals associated with the grant

applications, the disclosure of which

would constitute a clearly unwarranted

invasion of personal privacy.

Name of Committee: National Cancer

Institute Special Emphasis Panel Cooperative

Trials in Diagnostic Imaging.

Date: August 11–12, 1998.

Time: 7:00 p.m. to 3:00 p.m.

Agenda: To review and evaluate grant

applications.

Place: Ramada Inn, 1775 Rockville Pike,

Rockville, MD 20852.

Contact Person: Ray Bramhall, Scientific

Review Administrator, Special Review,

Referral and Resources Branch, Division of

Extramural Activities, National Cancer

Institute, National Institutes of Health, 6130

Executive Blvd., Rockville, MD 20892, (301)

496–3428.

This notice is being published less than 15

days prior to the meeting due to the timing

limitations imposed by the review and

funding cycle.

(Catalogue of Federal Domestic Assistance

Program Nos. 93.392, Cancer Construction;

93.393, Cancer Cause and Prevention

Research; 93.394, Cancer Detection and

Diagnosis Research; 93.395, Cancer

Treatment Research; 93.396, Cancer Biology

Research; 93.397, Cancer Centers Support;

93.398, Cancer Research Manpower; 93.399,

Cancer Control, National Institutes of Health,

HHS)

Dated: July 31, 1998.

LaVerne Y. Stringfield,

Committee Management Officer, NIH.

[FR Doc. 98–21240 Filed 8–6–98; 8:45 am]

BILLING CODE 4140–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

National Cancer Institute; Notice of

Closed Meeting

Pursuant to section 10(d) of the

Federal Advisory Committee Act, as

amended (5 U.S.C. Appendix 2), notice

is hereby given of the following

meeting.

The meeting will be closed to the

pubic in accordance with the provisions

set forth in sections 552b(c)(4) and

552b(c)(6), Title 5 U.S.C., as amended.

The contract proposals and the

discussions could disclose confidential

trade secrets or commercial property

such as patentable material, and

personal information concerning

individuals associated with the contract

proposals, the disclosure of which

would constitute a clearly unwarranted

invasion of personal privacy.

Name of Committee: National Cancer

Institute Special Emphasis Panel Prostate,

Lung Colorectal and Ovarian Cancer

Screening Trial Expansion.

Date: August 10, 1998.

Time: 12:00 PM to 2:00 PM.

Agenda: To review and evaluate contract

proposals.

Place: 6130 Executive Blvd. 6th Floor,

Rockville, MD 20852.

Contact Person: Wilna A. Woods, Deputy

Chief, Special Review, Referral and Research

Branch, Division of Extramural Activities,

National Cancer Institute, National Institutes

of Health, Rockeville, MD 20852, (301) 496–

7903.

This notice is being published less than 15

days prior to the meeting due to the timing

limitations imposed by the review and

funding cycle.

(Catalogue of Federal Domestic Assistance

Program Nos. 93.393, Cancer Cause and

Prevention Research; 93.394, Cancer

Detection and Diagnosis Research; 93.395,

Cancer Treatment Research; 93.396, Cancer

Biology Research; 93.397, Cancer Centers

Support; 93.398, Cancer Research Manpower;

93.399, Cancer Control; 93.392, Cancer

Construction, National Institutes of Health,

HHS)

Dated: August 4, 1998.

LaVerne Y. Stringfield,

Committee Management Officer, NIH.

[FR Doc. 98–21246 Filed 8–6–98; 8:45 am]

BILLING CODE 4140–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

National Center For Research

Resources; Notice of Closed Meetings

Pursuant to section 10(d) of the

Federal Advisory Committee Act, as

amended (5 U.S.C. Appendix 2), notice

is hereby given of the following

meetings.

The meetings will be closed to the

public in accordance with the

provisions set forth in sections

552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,

as amended. The grant applications and

the discussions could disclose

confidential trade secrets or commercial

property such as patentable material,

and personal information concerning

individuals associated with the grant

applications, the disclosure of which

would constitute a clearly unwarranted

invasion of personal privacy.

Name of Committee: National Center for

Research Resources Special Emphasis Panel,

American Type Culture Collection (ATCC)

Contract Evaluation.

Date: September 2, 1998.

Time: 8 a.m. to 5 p.m.

Agenda: To review and evaluate contract

proposals.

Place: The Bethesda Ramada, Ambassador

One, 8400 Wisconsin Avenue, Bethesda, MD

20814.

Contact Person: D.G. Patel, PHD, Scientific

Review Administrator, Office of Review,

National Center For Research Resources,

6705 Rockledge Drive, MSC 7965, Room

6018, Bethesda, MD 20892–7965, 301–435–

0824.

Name of Committee: National Center for

Research Resources Special Emphasis Panel

Small Business Innovation Research.

Date: October 8, 1998.

Time: 10 a.m. to 12 p.m.

Agenda: To review and evaluate contract

proposals.

Place: 6705 Rockledge Drive, Suite 6018,

Bethesda, MD 20892, (Telephone Conference

Call).

Contact Person: D.G. Patel, PHD, Scientific

Review Administrator, Office of Review,

National Center for Research Resources, 6705

Rockledge Drive, MSC 7965, Room 6018,

Bethesda, MD 20892–7965, 301–435–0824.

(Catalogue of Federal Domestic Assistance

Program Nos. 93.306, Comparative Medicine,

93.306; 93.333, Clinical Research, 93.333;

93.371, Biomedical Technology; 93.389,

Research Infrastructure, National Institutes of

Health, HHS)

Dated: July 31, 1998.

LaVerne Y. Stringfield,

Committee Management Officer, NIH.

[FR Doc. 98–21241 Filed 8–6–98; 8:45 am]

BILLING CODE 4140–01–M