31246 Federal Register / Vol. 66, No. 112 / Monday, June 11, 2001 / Notices

1As part of its obligations under the Privacy Act,

the Department previously announced a $10 fee for

health care practitioners, providers or suppliers to

self-query (64 FR 58851; November 1, 1999).

1The Advisory Opinions and the Special Fraud

Alert can be found on the OIG web site at http://

www.hhs.gov/oig.

2The reports issued by the Office of Evaluation

and Inspections also can be found on the OIG web

site.

EFFECTIVE DATE: This increase will be

effective on October 1, 2001.

SUPPLEMENTARY INFORMATION:

User Fee Amount

Section 1128E(d)(2) of the Social

Security Act (the Act), as added by

section 221(a) of the Health Insurance

Portability and Accountability Act

(HIPAA) of 1996, specifically authorizes

the establishment of fees for the costs of

processing requests for disclosure and

for providing such information, and the

final regulations at 45 CFR part 61 set

forth the criteria and procedures for

information to be reported to and

disclosed by the HIPDB. The Act

requires that the Department recover the

full costs of operating the HIPDB

through user fees. In determining any

changes in the amount of the user fee,

the Department is employing the criteria

set forth in § 61.13(b) of the HIPDB

regulations.

Specifically, § 61.13(b) states that the

amount of each fee will be determined

based on the following criteria:

• Direct and indirect personnel costs;

• Physical overhead, consulting, and

other indirect costs including rent and

depreciation on land, buildings and

equipment;

• Agency management and

supervisory costs;

• Costs of enforcement, research and

establishment of regulations and

guidance;

• Use of electronic data processing

equipment to collect and maintain

information, i.e., the actual cost of the

service, including computer search

time, runs and printouts; and

• Any other direct or indirect costs

related to the provision of services.

The current fee structure of $4 for

each separate query submitted by

authorized entities was announced in a

Federal Register notice on March 3,

2000 (65 FR 11589). Based on the above

criteria and our analysis of the

comparative costs of the various

methods for filing and paying for

queries, the Department is now

increasing the fee for each query

submitted by authorized entities by one

dollar—from $4 to $5.1

When an authorized entity query is

submitted for information on one or

more health care practitioners,

providers or suppliers, the appropriate

total fee will be $5 multiplied by the

number of individuals or organizations

about whom information is being

requested.

In order to minimize administrative

costs, the Department will accept

queries submitted by authorized entities

by credit card or electronic funds

transfer. The Department will continue

to accept payment for self-queries only

by credit card. The HIPDB accepts Visa,

MasterCard, and Discover. To submit

queries, registered entities (including

law enforcement agencies) must use the

HIPDB web site at www.npdbhipdb.com.

The Department will continue to

review the user fee periodically, and

will revise it as necessary. Any future

changes in the fee and its effective date

will be announced through notice in the

Federal Register.

Examples

Query method

Fee per

name in

query, by

method of

payment

Examples

Authorized Entity query ......................................................................................... $5.00 10 names in query: 10 × $5 = $50.00.

Self-query .............................................................................................................. $10.00 10 self-queries 10 × 10 = $100.

Dated: May 31, 2001.

Michael F. Mangano,

Acting Inspector General.

[FR Doc. 01–14599 Filed 6–8–01; 8:45 am]

BILLING CODE 4152–01–U

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Office of Inspector General

Solicitation of Information and

Recommendations for Developing a

Compliance Program Guidance for the

Pharmaceutical Industry

AGENCY: Office of Inspector General

(OIG), HHS.

ACTION: Notice.

SUMMARY: This Federal Register notice

seeks the input and recommendations of

interested parties as the OIG develops a

compliance program guidance for the

pharmaceutical industry, especially

those segments of the industry related to

manufacturing, marketing or providing

goods or services to Medicare, Medicaid

and other Federal health care program

beneficiaries. The pharmaceutical

industry has experienced a number of

instances of fraud and abuse and has

expressed interest in increasing the

awareness of the industry to assist in

protecting against such conduct. In

response to the industry’s concerns, the

OIG has written Advisory Opinions on

a variety of industry-related issues and,

in 1994, published a Special Fraud Alert

relating to Prescription Drug Marketing

Schemes.1 Also, in the early 1990s, the

OIG’s Office of Evaluation and

Inspections issued reports relating to

prescription drug promotional

practices.2

In an effort to provide further

guidance, the OIG is soliciting

comments, recommendations and other

suggestions from concerned parties and

organizations on how best to develop a

compliance program guidance for the

pharmaceutical industry to reduce the

potential for fraud and abuse.

DATES: To assure consideration,

comments must be delivered to the

address provided below by no later than

5 p.m. on August 10, 2001.

ADDRESSES: Please mail or deliver your

written comments, recommendations

and suggestions to the following

address:Department of Health and

Human Services,Office of Inspector

General,Attention: OIG–8–CPG,Room

5527 A, Cohen Building,330

Independence Avenue,

SW.,Washington, DC 20201.

We do not accept comments by

facsimile (FAX) transmission. In

commenting, please refer to the file code

OIG–8–CPG. Timely-filed comments

will be available for public inspection as

they are received, generally beginning

approximately 3 weeks after receipt of a

document, in Room 5541 of the Office

of Inspector General at 330

Independence Avenue, S.W.,

Washington, D.C. 20201 on Monday

Federal Register / Vol. 66, No. 112 / Monday, June 11, 2001 / Notices 31247

3The OIG has issued compliance program

guidance for the following nine industry sectors:

hospitals, clinical laboratories, home health

agencies, durable medical equipment suppliers,

third-party medical billing companies, hospices,

Medicare+Choice organizations offering

coordinated care plans, nursing facilities, and

individual and small group physician practices.

The compliance program guidances for these

industry sectors can be found on the OIG web site

at http://www.hhs.gov/oig or by calling the OIG

Public Affairs office at (202) 619–1343.

through Friday of each week from 8 a.m.

to 4:30 p.m.

FOR FURTHER INFORMATION CONTACT:

Mary E. Riordan or Nicole C. Hall,

Office of Counsel to the Inspector

General, (202) 619–2078.

SUPPLEMENTARY INFORMATION: The

development of compliance program

guidances has become a major initiative

of the OIG in its effort to engage the

private health care industry in

addressing and combating fraud and

abuse. Over the past several years, the

OIG has developed and issued

compliance program guidances directed

at various segments of the health care

industry.3 These guidances are designed

to provide clear direction and assistance

to specific sections of the health care

industry that are interested in reducing

and eliminating fraud and abuse within

their organizations.

The guidances have represented the

culmination of the OIG’s suggestions on

how providers can most effectively

establish internal controls and

implement monitoring procedures to

identify, correct and prevent fraudulent

or wasteful activities. The suggestions

contained in the guidances are not

mandatory for providers, nor do they

represent an exclusive discussion of the

advisable elements of a compliance

program.

The compliance program guidance for

the pharmaceutical industry will be

designed to reach segments of the health

care industry which have not been

covered by previous guidances, but

which have recently been the subject of

increasing scrutiny, such as

pharmaceutical manufacturers and retail

pharmacy chains. As the public debate

about prescription drug costs and a

potential expansion of the Medicare

drug benefit continues, this scrutiny is

likely to intensify.

Through this Federal Register notice,

the OIG is seeking input from interested

parties as the OIG considers developing

a compliance program guidance

directed at the pharmaceutical industry.

The OIG will consider all comments,

recommendations and suggestions

received within the time frame

indicated above.

We anticipate that the guidance for

the pharmaceutical industry 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 programs;

• 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 initiate

corrective action.

The OIG would appreciate specific

comments, recommendations and

suggestions on (1) risk areas for the

pharmaceutical industry, and (2) aspects

of the seven elements contained in the

previous guidances that may need to be

modified to reflect the unique

characteristics of the pharmaceutical

industry. Detailed justifications and

empirical data supporting any

suggestions would be appreciated.

We request that any comments,

recommendations and suggestions be

submitted in a format that addresses the

topics outlined above in a concise

manner, rather than in the form of a

comprehensive draft guidance that

mirrors previous guidances.

Dated: May 31, 2001.

Michael F. Mangano,

Acting Inspector General,

[FR Doc. 01–14598 Filed 6–8–01; 8:45 am]

BILLING CODE 4152–01–U

DEPARTMENT OF THE INTERIOR

Fish and Wildlife Service

Notice of Intent To Prepare a

Comprehensive Conservation Plan

AGENCY: U.S. Fish and Wildlife Service,

Department of the Interior.

ACTION: Notice of intent to prepare a

Comprehensive Conservation Plan and

Associated National Environmental

Policy Act Document for the

Sacramento River National Wildlife

Refuge, Butte, Glenn, and Tehama

Counties, California.

SUMMARY: The U.S. Fish and Wildlife

Service (Service) is preparing a

Comprehensive Conservation Plan

(CCP) and National Environmental

Policy Act (NEPA) document for

Sacramento River National Wildlife

Refuge (NWR). This notice advises the

public that the Service intends to gather

information necessary to prepare a CCP

and environmental documents pursuant

to the National Wildlife Refuge System

Administration Act of 1966, as

amended, and NEPA. The public is

invited to participate in the planning

process. The Service is furnishing this

notice in compliance with the Service

CCP policy:

1. To advise other agencies and the

public of our intentions, and

2. To obtain suggestions and

information on the scope of issues to

include in the environmental

documents.

3. To announce a series of public

open houses to occur in May and June

2001. Information about the time and

location of the open house is available

by contacting the Refuge.

DATES: To ensure that the Service has

adequate time to evaluate and

incorporate suggestions and other input

into the planning process, comments

should be received on or before July 11,

2001.

ADDRESSES: Send written comments or

requests to be added to the mailing list

to the following address: Planning Team

Leader—Sacramento River NWR,

California / Nevada Refuge Planning

Office, U.S. Fish and Wildlife Service,

2800 Cottage Way, W–1916,

Sacramento, California, 95825.

FOR FURTHER INFORMATION CONTACT: Mr.

Miki Fujitsubo, Planning Team Leader,

(916) 414–6507.

History and Background

The Refuge was established in 1989

by the authority provided under the

Endangered Species Act of 1973 and the

Emergency Wetlands Resources Act of

1986, using monies made available

through the Land and Water

Conservation Fund Act of 1965. The

Service proposed acquisition of 18,000

acres of land for establishment of the

multi-unit Sacramento River NWR. The

multiple units of the refuge are located

along both banks of the Sacramento

River between Red Bluff and Princeton

in Glenn, Butte, and Tehama Counties,

California. A combination of fee title

and conservation easement acquisitions

was used to protect this habitat.

Riparian habitat along the Sacramento

River has been identified as critically

important for various threatened and

endangered species, fish, migratory

birds, plants, and to the natural

ecosystem of the River itself. There has

been an 89 percent reduction of riparian

vegetation throughout the Sacramento