[Federal Register Volume 68, Number 86 (Monday, May 5, 2003)]
[Notices]
[Pages 23731-23743]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-10949]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office of Inspector General


OIG Compliance Program Guidance for Pharmaceutical Manufacturers

AGENCY: Office of Inspector General (OIG), HHS.

ACTION: Notice

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SUMMARY: This Federal Register notice sets forth the recently issued 
Compliance Program Guidance for Pharmaceutical Manufacturers developed 
by the Office of Inspector General (OIG). Through this notice, the OIG 
is setting forth its general views on the value and fundamental 
principles of compliance programs for pharmaceutical manufacturers and 
the specific elements that pharmaceutical manufacturers should consider 
when developing and implementing an effective compliance program.

FOR FURTHER INFORMATION CONTACT: Mary E. Riordan or Nicole C. Hall, 
Office of Counsel to the Inspector General, (202) 619-2078.

SUPPLEMENTARY INFORMATION:

Background

    Compliance program guidance is a major initiative of the OIG in its 
effort to engage the health care community in preventing and reducing 
fraud and abuse in federal health care programs. The purpose of the 
compliance program guidance is to encourage the use of internal 
controls to efficiently monitor adherence to applicable statutes, 
regulations and program requirements. In the last several years, the 
OIG has developed and issued compliance program guidance directed at 
the following segments of the health care industry: the hospital 
industry; home health agencies; clinical laboratories; third-party 
medical billing companies; the durable medical equipment, prosthetics, 
orthotics and supply industry; Medicare+Choice organizations offering 
coordinated care plans; hospices; nursing facilities; individual and 
small group physician practices; and ambulance suppliers.
    Copies of these compliance program guidances can be found on the 
OIG Web site at http://oig.hhs.gov/fraud/complianceguidance.html.

Developing the Compliance Program Guidance for Pharmaceutical 
Manufacturers

    On June 11, 2001, the OIG published a solicitation notice seeking 
information and recommendations for developing compliance program 
guidance for the pharmaceutical industry (66 FR 31246). In response to 
that solicitation notice, the OIG received eight comments from various 
outside sources. We carefully considered those comments, as well as 
previous OIG publications, such as other compliance program guidances 
and Special Fraud Alerts. In addition, we have taken into account past 
and ongoing fraud investigations conducted by the OIG's Office of 
Investigations and the Department of Justice, and have consulted with 
the Centers for Medicare and Medicaid Services (CMS) (formerly known as 
the Health Care Financing Administration). In an effort to ensure that 
all parties had a reasonable opportunity to provide input into a final 
product, draft compliance program guidance for the pharmaceutical 
industry was published in the Federal Register on October 3, 2002 (67 
FR 62057) for further comments and recommendations.

Elements for an Effective Compliance Program

    This compliance program guidance for pharmaceutical manufacturers 
contains seven elements that have been widely recognized as fundamental 
to an effective compliance program:
    [sbull] Implementing written policies and procedures;
    [sbull] Designating a compliance officer and compliance committee;
    [sbull] Conducting effective training and education;
    [sbull] Developing effective lines of communication;
    [sbull] Conducting internal monitoring and auditing;
    [sbull] Enforcing standards through well-publicized disciplinary 
guidelines; and
    [sbull] Responding promptly to detected problems and undertaking 
corrective action.
    These elements are included in previous guidances issued by the 
OIG. As with previously issued guidances, this compliance program 
guidance represents the OIG's suggestions on how pharmaceutical 
manufacturers can establish internal controls to ensure adherence to 
applicable rules and program requirements. The contents of this 
guidance should not be viewed as mandatory or as an exclusive 
discussion of the advisable elements of a compliance program. The 
document is intended to present voluntary guidance to the industry and 
not to represent binding standards for pharmaceutical manufacturers.

Office of Inspector General's Compliance Program Guidance for 
Pharmaceutical Manufacturers

I. Introduction

    The Office of Inspector General (OIG) of the Department of Health 
and Human Services is continuing in its efforts to promote voluntary 
compliance programs for the health care industry. This compliance 
guidance is intended to assist companies that develop, manufacture, 
market, and sell pharmaceutical drugs or biological products 
(pharmaceutical manufacturers) in developing and implementing internal 
controls and procedures that promote adherence to applicable statutes, 
regulations, and requirements of the federal health care programs\1\ 
and in evaluating and, as necessary, refining existing compliance 
programs.
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    \1\ (Endnotes appear at end of document)
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    This guidance provides the OIG's views on the fundamental elements 
of pharmaceutical manufacturer compliance programs and principles that 
each pharmaceutical manufacturer should consider when creating and 
implementing an effective compliance program. This guide is not a 
compliance program. Rather, it is a set of guidelines that 
pharmaceutical manufacturers should consider when developing and 
implementing a compliance program or evaluating an existing one. For 
those manufacturers with an existing compliance program, this guidance 
may serve as a benchmark or comparison against which to measure ongoing 
efforts.
    A pharmaceutical manufacturer's implementation of an effective 
compliance program may require a significant commitment of time and 
resources by various segments of the organization. In order for a 
compliance program to be effective, it must have the support and 
commitment of senior management and the company's governing body. In 
turn, the corporate leadership should strive to foster a culture that 
promotes the prevention, detection, and resolution of instances of 
problems. Although an effective compliance program may require a 
reallocation of existing resources, the long-term benefits of 
establishing a compliance program significantly outweigh the initial 
costs.
    In a continuing effort to collaborate closely with the 
pharmaceutical industry, the OIG published a notice in

[[Page 23732]]

the Federal Register soliciting comments and recommendations on what 
should be included in this compliance program guidance.\2\ Following 
our review of comments received in response to the solicitation notice, 
we published draft compliance guidance in the Federal Register in order 
to solicit further comments and recommendations.\3\ In addition to 
considering the comments received in response to that solicitation 
notice and the draft compliance guidance, in finalizing this guidance 
we reviewed previous OIG publications, including OIG advisory opinions, 
safe harbor regulations (including the preambles) relating to the 
federal anti-kickback statute,\4\ Special Fraud Alerts, as well as 
reports issued by the OIG's Office of Audit Services and Office of 
Evaluation and Inspections relevant to the pharmaceutical industry. 
(These materials are available on the OIG Web page at http://oig.hhs.gov.) In addition, we relied on the experience gained from 
investigations of pharmaceutical manufacturers conducted by OIG's 
Office of Investigations, the Department of Justice, and the state 
Medicaid Fraud Control Units. We also held meetings with four groups of 
industry stakeholders--Pharmaceutical Research and Manufacturers of 
America (PhRMA) and pharmaceutical manufacturer representatives; health 
plan and health plan association representatives; representatives of 
pharmacy benefit managers (PBMs) and representatives of the American 
Medical Association (AMA) and its member organizations.

A. Benefits of a Compliance Program

    The OIG believes a comprehensive compliance program provides a 
mechanism that addresses the public and private sectors' mutual goals 
of reducing fraud and abuse; enhancing health care provider operational 
functions; improving the quality of health care services; and reducing 
the cost of health care. Attaining these goals provides positive 
results to the pharmaceutical manufacturer, the government, and 
individual citizens alike. In addition to fulfilling its legal duty to 
avoid submitting false or inaccurate pricing or rebate information to 
any federal health care program or engaging in illegal marketing 
activities, a pharmaceutical manufacturer may gain important additional 
benefits by voluntarily implementing a compliance program. The benefits 
may include:
    [sbull] A concrete demonstration to employees and the community at 
large of the company's commitment to honest and responsible corporate 
conduct;
    [sbull] An increased likelihood of preventing, or at least 
identifying, and correcting unlawful and unethical behavior at an early 
stage;
    [sbull] A mechanism to encourage employees to report potential 
problems and allow for appropriate internal inquiry and corrective 
action; and
    [sbull] Through early detection and reporting, minimizing any 
financial loss to the government and any corresponding financial loss 
to the company.
    The OIG recognizes that the implementation of a compliance program 
may not entirely eliminate improper conduct from the operations of a 
pharmaceutical manufacturer. However, a good faith effort by the 
company to comply with applicable statutes and regulations as well as 
federal health care program requirements, demonstrated by an effective 
compliance program, significantly reduces the risk of unlawful conduct 
and any penalties that result from such behavior.

B. Application of Compliance Program Guidance

    Given the wide diversity within the pharmaceutical industry, there 
is no single ``best'' pharmaceutical manufacturer compliance program. 
The OIG recognizes the complexities of this industry and the 
differences among industry members. Some pharmaceutical manufacturers 
are small and may have limited resources to devote to compliance 
measures. Conversely, other companies are well-established, large 
multi-national corporations with a widely dispersed work force. Some 
companies may have well-developed compliance programs already in place; 
others only now may be initiating such efforts. The OIG also recognizes 
that pharmaceutical manufacturers are subject to extensive regulatory 
requirements in addition to fraud and abuse-related issues and that 
many pharmaceutical manufacturers have addressed these obligations 
through compliance programs. Accordingly, the OIG strongly encourages 
pharmaceutical manufactures to develop and implement or refine (as 
necessary) compliance elements that uniquely address the areas of 
potential problems, common concern, or high risk that apply to their 
own companies (or, as applicable, to the U.S. operations of their 
companies).
    For example, although they are not exhaustive of all potential risk 
areas, the OIG has identified three major potential risk areas for 
pharmaceutical manufacturers: (1) Integrity of data used by state and 
federal governments to establish payment; (2) kickbacks and other 
illegal remuneration; and (3) compliance with laws regulating drug 
samples. The risk areas are discussed in greater detail in section 
II.B.2. below. The compliance measures adopted by a pharmaceutical 
manufacturer should be tailored to fit the unique environment of the 
company (including its organizational structure, operations and 
resources, as well as prior enforcement experience). In short, the OIG 
recommends that each pharmaceutical manufacturer should adapt the 
objectives and principles underlying the measures outlined in this 
guidance to its own particular circumstances.\5\

II. Compliance Program Elements

A. The Basic Compliance Elements

    The OIG believes that every effective compliance program must begin 
with a formal commitment by the pharmaceutical manufacturer's board of 
directors or other governing body. Evidence of that commitment should 
include the allocation of adequate resources, a timetable for the 
implementation of the compliance measures, and the identification of an 
individual to serve as a compliance officer to ensure that each of the 
recommended and adopted elements is addressed. Once a commitment has 
been undertaken, a compliance officer should immediately be chosen to 
oversee the implementation of the compliance program.
    The elements listed below provide a comprehensive and firm 
foundation upon which an effective compliance program may be built. 
Further, they are likely to foster the development of a corporate 
culture of compliance. The OIG recognizes that full implementation of 
all elements may not be immediately feasible for all pharmaceutical 
manufacturers. However, as a first step, a good faith and meaningful 
commitment on the part of the company's management will substantially 
contribute to the program's successful implementation. As the 
compliance program is implemented, that commitment should filter down 
through management to every employee and contractor of the 
pharmaceutical manufacturer, as applicable for the particular 
individual.
    At a minimum, a comprehensive compliance program should include the 
following elements:
    (1) The development and distribution of written standards of 
conduct, as well as written policies, procedures and protocols that 
verbalize the company's commitment to compliance (e.g., by including 
adherence to the compliance

[[Page 23733]]

program as an element in evaluating management and employees) and 
address specific areas of potential fraud and abuse, such as the 
reporting of pricing and rebate information to the federal health care 
programs, and sales and marketing practices;
    (2) The designation of a compliance officer and other appropriate 
bodies (e.g., a corporate compliance committee) charged with the 
responsibility for developing, operating, and monitoring the compliance 
program, and with authority to report directly to the board of 
directors and/or the president or CEO;
    (3) The development and implementation of regular, effective 
education and training programs for all affected employees;
    (4) The creation and maintenance of an effective line of 
communication between the compliance officer and all employees, 
including a process (such as a hotline or other reporting system) to 
receive complaints or questions, and the adoption of procedures to 
protect the anonymity of complainants and to protect whistleblowers 
from retaliation;
    (5) The use of audits and/or other risk evaluation techniques to 
monitor compliance, identify problem areas, and assist in the reduction 
of identified problems;
    (6) The development of policies and procedures addressing the non-
employment or retention of individuals or entities excluded from 
participation in federal health care programs, and the enforcement of 
appropriate disciplinary action against employees or contractors who 
have violated company policies and procedures and/or applicable federal 
health care program requirements; and
    (7) The development of policies and procedures for the 
investigation of identified instances of noncompliance or misconduct. 
These should include directions regarding the prompt and proper 
response to detected offenses, such as the initiation of appropriate 
corrective action and preventive measures and processes to report the 
offense to relevant authorities in appropriate circumstances.

B. Written Policies and Procedures

    In developing a compliance program, every pharmaceutical 
manufacturer should develop and distribute written compliance 
standards, procedures, and practices that guide the company and the 
conduct of its employees in day-to-day operations. These policies and 
procedures should be developed under the direction and supervision of 
the compliance officer, the compliance committee, and operational 
managers. At a minimum, the policies and procedures should be provided 
to all employees who are affected by these policies, and to any agents 
or contractors who may furnish services that impact federal health care 
programs (e.g., contractors involved in the co-promotion of a 
manufacturer's products).
1. Code of Conduct
    Although a clear statement of detailed and substantive policies and 
procedures is at the core of a compliance program, the OIG recommends 
that pharmaceutical manufacturers also develop a general corporate 
statement of ethical and compliance principles that will guide the 
company's operations. One common expression of this statement of 
principles is the code of conduct. The code should function in the same 
fashion as a constitution, i.e., as a document that details the 
fundamental principles, values, and framework for action within an 
organization. The code of conduct for a pharmaceutical manufacturer 
should articulate the company's expectations of commitment to 
compliance by management, employees, and agents, and should summarize 
the broad ethical and legal principles under which the company must 
operate. Unlike the more detailed policies and procedures, the code of 
conduct should be brief, easily readable, and cover general principles 
applicable to all employees.
    As appropriate, the OIG strongly encourages the participation and 
involvement of the pharmaceutical manufacturer's board of directors, 
CEO, president, members of senior management, and other personnel from 
various levels of the organizational structure in the development of 
all aspects of the compliance program, especially the code of conduct. 
Management and employee involvement in this process communicates a 
strong and explicit commitment by management to foster compliance with 
applicable federal health care program requirements. It also 
communicates the need for all employees to comply with the 
organization's code of conduct and policies and procedures.
2. Specific Risk Areas
    This section is intended to help prudent pharmaceutical 
manufacturers identify areas of their operations that present potential 
risk of liability under several key federal fraud and abuse statutes 
and regulations.\6\ This section focuses on areas that are currently of 
concern to the enforcement community and is not intended to address all 
potential risk areas for pharmaceutical manufacturers. Importantly, the 
identification of a particular practice or activity in this section is 
not intended to imply that the practice or activity is necessarily 
illegal in all circumstances or that it may not have a valid or lawful 
purpose underlying it.
    This section addresses the following areas of significant concern 
for pharmaceutical manufacturers: (1) Integrity of data used by state 
and federal governments to establish payment amounts; (2) kickbacks and 
other illegal remuneration; and (3) compliance with laws regulating 
drug samples.
    This guidance does not create any new law or legal obligations, and 
the discussions that follow are not intended to present detailed or 
comprehensive summaries of lawful and unlawful activity. Rather, these 
discussions should be used as a starting point for a manufacturer's 
legal review of its particular practices and for development of 
policies and procedures to reduce or eliminate potential risk.
    a. Integrity of Data Used To Establish or Determine Government 
Reimbursement. Many federal and state health care programs establish or 
ultimately determine reimbursement rates for pharmaceuticals, either 
prospectively or retrospectively, using price and sales data directly 
or indirectly furnished by pharmaceutical manufacturers. The government 
sets reimbursement with the expectation that the data provided are 
complete and accurate. The knowing submission of false, fraudulent, or 
misleading information is actionable. A pharmaceutical manufacturer may 
be liable under the False Claims Act\7\ if government reimbursement 
(including, but not limited to, reimbursement by Medicare and Medicaid) 
for the manufacturer's product depends, in whole or in part, on 
information generated or reported by the manufacturer, directly or 
indirectly, and the manufacturer has knowingly (as defined in the False 
Claims Act) failed to generate or report such information completely 
and accurately. Manufacturers may also be liable for civil money 
penalties under various laws, rules and regulations. Moreover, in some 
circumstances, inaccurate or incomplete reporting may be probative of 
liability under the federal anti-kickback statute.
    Where appropriate, manufacturers' reported prices should accurately 
take into account price reductions, cash discounts, free goods 
contingent on a purchase agreement, rebates, up-front payments, 
coupons, goods in kind, free or reduced-price services, grants, or

[[Page 23734]]

other price concessions or similar benefits offered to some or all 
purchasers. Any discount, price concession, or similar benefit offered 
on purchases of multiple products should be fairly apportioned among 
the products (and could potentially raise anti-kickback issues). 
Underlying assumptions used in connection with reported prices should 
be reasoned, consistent, and appropriately documented, and 
pharmaceutical manufacturers should retain all relevant records 
reflecting reported prices and efforts to comply with federal health 
care program requirements.
    Given the importance of the Medicaid Rebate Program, as well as 
other programs that rely on Medicaid Rebate Program benchmarks (such as 
the 340B Program \8\), manufacturers should pay particular attention to 
ensuring that they are calculating Average Manufacturer Price and Best 
Price accurately and that they are paying appropriate rebate amounts 
for their drugs.\9\
    In sum, pharmaceutical manufacturers are responsible for ensuring 
the integrity of data they generate that is used for government 
reimbursement purposes.
    b. Kickbacks and Other Illegal Remuneration--A. General 
Considerations. Pharmaceutical manufacturers, as well as their 
employees and agents, should be aware of the federal anti-kickback 
statute and the constraints it places on the marketing and promotion of 
products reimbursable by the federal health care programs, including, 
but not limited to, Medicare and Medicaid. In the health care sector, 
many common business activities, including, for example, sales, 
marketing, discounting, and purchaser relations, potentially implicate 
the anti-kickback statute. Pharmaceutical manufacturers and their 
employees and agents should be aware that the anti-kickback statute 
prohibits in the health care industry some practices that are common in 
other business sectors. In short, practices that may be common or 
longstanding in other businesses are not necessarily acceptable or 
lawful when soliciting federal health care program business.
    The anti-kickback statute is a criminal prohibition against 
payments (in any form, whether the payments are direct or indirect) 
made purposefully to induce or reward the referral or generation of 
federal health care business. The anti-kickback statute addresses not 
only the offer or payment of anything of value for patient referrals, 
but also the offer or payment of anything of value in return for 
purchasing, leasing, ordering, or arranging for or recommending the 
purchase, lease, or ordering of any item or service reimbursable in 
whole or part by a federal health care program. The statute extends 
equally to the solicitation or acceptance of remuneration for 
referrals. Liability under the anti-kickback statute is determined 
separately for each party involved. In addition to criminal penalties, 
violators may be subject to civil monetary sanctions and exclusion from 
the federal health care programs. Under certain circumstances, a 
violation of the anti-kickback statute may give rise to liability under 
the False Claims Act.
    Although liability under the anti-kickback statute ultimately turns 
on a party's intent, it is possible to identify arrangements or 
practices that may present a significant potential for abuse. 
Initially, a manufacturer should identify any remunerative relationship 
between itself (or its representatives) and persons or entities in a 
position to generate federal health care business for the manufacturer 
directly or indirectly. Persons or entities in a position to generate 
federal health care business include, for example, purchasers, benefit 
managers, formulary committee members, group purchasing organizations 
(GPOs), physicians and certain allied health care professionals, and 
pharmacists. The next step is to determine whether any one purpose of 
the remuneration may be to induce or reward the referral or 
recommendation of business payable in whole or in part by a Federal 
health care program. Importantly, a lawful purpose will not legitimize 
a payment that also has an unlawful purpose.
    Although any arrangement satisfying both tests requires careful 
scrutiny from a manufacturer, the courts have identified several 
potentially aggravating considerations that can be useful in 
identifying arrangements at greatest risk of prosecution. In 
particular, manufacturers should ask the following questions, among 
others, about any problematic arrangements or practices they identify:
    [sbull] Does the arrangement or practice have a potential to 
interfere with, or skew, clinical decision-making? Does it have a 
potential to undermine the clinical integrity of a formulary process? 
If the arrangement or practice involves providing information to 
decision-makers, prescribers, or patients, is the information complete, 
accurate, and not misleading?
    [sbull] Does the arrangement or practice have a potential to 
increase costs to the federal health care programs, beneficiaries, or 
enrollees? Does the arrangement or practice have the potential to be a 
disguised discount to circumvent the Medicaid Rebate Program Best Price 
calculation?
    [sbull] Does the arrangement or practice have a potential to 
increase the risk of overutilization or inappropriate utilization?
    [sbull] Does the arrangement or practice raise patient safety or 
quality of care concerns?
    Manufacturers that have identified problematic arrangements or 
practices can take a number of steps to reduce or eliminate the risk of 
an anti-kickback violation. Detailed guidance relating to a number of 
specific practices is available from several sources. Most importantly, 
the anti-kickback statute and the corresponding regulations establish a 
number of ``safe harbors'' for common business arrangements, including 
personal services and management contracts, 42 CFR 1001.952(d), 
warranties, 42 CFR 1001.952(g), discounts, 42 CFR 1001.952(h), 
employment, 42 CFR 1001.952(i), GPOs, 42 CFR 1001.952(j), and certain 
managed care and risk sharing arrangements, 42 CFR 1001.952(m), (t), 
and (u). Safe harbor protection requires strict compliance with all 
applicable conditions set out in the relevant safe harbor. Although 
compliance with a safe harbor is voluntary and failure to comply with a 
safe harbor does not mean an arrangement is illegal, many arrangements 
can be structured to fit in safe harbors, and we recommend that 
pharmaceutical manufacturers structure arrangements to fit in a safe 
harbor whenever possible. Other available guidance includes special 
fraud alerts and advisory bulletins issued by the OIG identifying and 
discussing particular practices or issues of concern and OIG advisory 
opinions issued to specific parties about their particular business 
arrangements. Parties may apply for an OIG advisory opinion using the 
procedures set out at 42 CFR part 1008. The safe harbor regulations 
(and accompanying Federal Register preambles), fraud alerts and 
bulletins, advisory opinions (and instructions for obtaining them), and 
other guidance are available on the OIG web site at http://oig.hhs.gov.
    B. Key Areas of Potential Risk. The following discussion highlights 
several known areas of potential risk. The propriety of any particular 
arrangement can only be determined after a detailed examination of the 
attendant facts and circumstances. The identification of a given 
practice or activity as ``suspect'' or as an area of ``risk'' does not 
mean it is necessarily illegal or unlawful, or that it

[[Page 23735]]

cannot be properly structured to fit in a safe harbor. Nor does it mean 
that the practice or activity is not beneficial from a clinical, cost, 
or other perspective. Rather, the areas identified below are those 
areas of activity that have a potential for abuse based on historical 
law enforcement experience and that should receive close scrutiny from 
manufacturers. The discussion highlights potential risks under the 
anti-kickback statute arising from pharmaceutical manufacturers' 
relationships with three groups: purchasers (including those using 
formularies) and their agents; persons and entities in a position to 
make or influence referrals (including physicians and other health care 
professionals); and sales agents.
    (1) Relationships with Purchasers and their Agents--(a) Discounts 
and Other Remuneration to Purchasers. Pharmaceutical manufacturers 
offer purchasers a variety of price concessions and other remuneration 
to induce the purchase of their products. Purchasers include direct 
purchasers (e.g., hospitals, nursing homes, pharmacies, some 
physicians), as well as indirect purchasers (e.g., health plans). 
Inducements offered to purchasers potentially implicate the anti-
kickback statute if the purchased products are reimbursable to the 
purchasers, in whole or in part, directly or indirectly, by any of the 
federal health care programs. Any remuneration from a manufacturer 
provided to a purchaser that is expressly or impliedly related to a 
sale potentially implicates the anti-kickback statute and should be 
carefully reviewed.
    Discounting arrangements are prevalent in the pharmaceutical 
industry and deserve careful scrutiny particularly because of their 
potential to implicate the Best Price requirements of the Medicaid 
Rebate Program. Because the Medicaid Rebate Program in many instances 
requires that states receive rebates based on the Best Price offered by 
a pharmaceutical manufacturer to other purchasers, manufacturers have a 
strong financial incentive to hide de facto pricing concessions to 
other purchasers to avoid passing on the same discount to the states. 
Because of the potential direct and substantial effect of such 
practices on federal health care program expenditures and the interest 
of some manufacturers in avoiding price concessions that would trigger 
rebates to the states, any remuneration from a manufacturer to a 
purchaser, however characterized, should be carefully scrutinized.
    Discounts. Public policy favors open and legitimate price 
competition in health care. Thus, the anti-kickback statute contains an 
exception for discounts offered to customers that submit claims to the 
federal health care programs, if the discounts are properly disclosed 
and accurately reported. See 42 U.S.C. 1320a-7b(b)(3)(A); 42 CFR 
1001.952(h). However, to qualify for the exception, the discount must 
be in the form of a reduction in the price of the good or service based 
on an arms-length transaction. In other words, the exception covers 
only reductions in the product's price. Moreover, the regulations 
provide that the discount must be given at the time of sale or, in 
certain cases, set at the time of sale, even if finally determined 
subsequent to the time of sale (i.e., a rebate).
    Manufacturers offering discounts should thoroughly familiarize 
themselves, and have their sales and marketing personnel familiarize 
themselves, with the discount safe harbor at 42 CFR 1001.952(h) (and, 
if relevant, the safe harbors for price reductions in the managed care 
context, 42 CFR 1001.952(m), (t), and (u)). In particular, 
manufacturers should pay attention to the discount safe harbor 
requirements applicable to ``sellers'' and ``offerors'' of discounts. 
Under the safe harbor, sellers and offerors have specific obligations 
that include (i) informing a customer of any discount and of the 
customer's reporting obligations with respect to that discount, and 
(ii) refraining from any action that would impede a customer's ability 
to comply with the safe harbor. To fulfill the safe harbor 
requirements, manufacturers will need to know how their customers 
submit claims to the federal health care programs (e.g., whether the 
customer is a managed care, cost-based, or charge-based biller). 
Compliance with the safe harbor is determined separately for each 
party.
    Product Support Services. Pharmaceutical manufacturers sometimes 
offer purchasers certain support services in connection with the sale 
of their products. These services may include billing assistance 
tailored to the purchased products, reimbursement consultation, and 
other programs specifically tied to support of the purchased product. 
Standing alone, services that have no substantial independent value to 
the purchaser may not implicate the anti-kickback statute. However, if 
a manufacturer provides a service having no independent value (such as 
limited reimbursement support services in connection with its own 
products) in tandem with another service or program that confers a 
benefit on a referring provider (such as a reimbursement guarantee that 
eliminates normal financial risks), the arrangement would raise 
kickback concerns. For example, the anti-kickback statute would be 
implicated if a manufacturer were to couple a reimbursement support 
service with a promise that a purchaser will pay for ordered products 
only if the purchaser is reimbursed by a federal health care program.
    Educational Grants. Pharmaceutical manufacturers sometimes provide 
grant funding for a wide range of educational activities. While 
educational funding can provide valuable information to the medical and 
health care industry, manufacturer grants to purchasers, GPOs, PBMs and 
similar entities raise concerns under the anti-kickback statute. 
Funding that is conditioned, in whole or in part, on the purchase of 
product implicates the statute, even if the educational or research 
purpose is legitimate. Furthermore, to the extent the manufacturer has 
any influence over the substance of an educational program or the 
presenter, there is a risk that the educational program may be used for 
inappropriate marketing purposes.
    To reduce the risks that a grant program is used improperly to 
induce or reward product purchases or to market product 
inappropriately, manufacturers should separate their grant making 
functions from their sales and marketing functions. Effective 
separation of these functions will help insure that grant funding is 
not inappropriately influenced by sales or marketing motivations and 
that the educational purposes of the grant are legitimate. 
Manufacturers should establish objective criteria for making grants 
that do not take into account the volume or value of purchases made by, 
or anticipated from, the grant recipient and that serve to ensure that 
the funded activities are bona fide. The manufacturer should have no 
control over the speaker or content of the educational presentation. 
Compliance with such procedures should be documented and regularly 
monitored.
    Research Funding. Manufacturers often contract with purchasers of 
their products to conduct research activities on behalf of the 
manufacturer on a fee-for-service basis. These contracts should be 
structured to fit in the personal services safe harbor whenever 
possible. Payments for research services should be fair market value 
for legitimate, reasonable, and necessary services. Post-marketing 
research activities should be especially scrutinized to ensure that 
they are legitimate and not simply a pretext to generate prescriptions 
of a drug. Prudent manufacturers will develop contracting procedures 
that

[[Page 23736]]

clearly separate the awarding of research contracts from marketing. 
Research contracts that originate through the sales or marketing 
functions--or that are offered to purchasers in connection with sales 
contacts--are particularly suspect.
    Pharmaceutical manufacturers sometimes provide funding to their 
purchasers for use in the purchasers' own research. In many cases, the 
research provides valuable scientific and clinical information, 
improves clinical care, leads to promising new treatments, promotes 
better delivery of health care, or otherwise benefits patients. 
However, as with educational grants, if linked directly or indirectly 
to the purchase of product, research grants can be misused to induce 
the purchase of business without triggering Medicaid Best Price 
obligations. To reduce risk, manufacturers should insulate research 
grant making from sales and marketing influences.
    Other remuneration to purchasers. As already noted, any 
remuneration from a manufacturer provided to a purchaser that is 
expressly or impliedly related to a sale potentially implicates the 
anti-kickback statute and should be carefully reviewed. Examples of 
remuneration in connection with a sale include, but are not limited to, 
``prebates'' and ``upfront payments,'' other free or reduced-price 
goods or services, and payments to cover the costs of ``converting'' 
from a competitor's product. Selective offers of remuneration (i.e., 
offers made to some but not all purchasers) may increase potential risk 
if the selection criteria relate directly or indirectly to the volume 
or value of business generated. In addition, manufacturers may contract 
with purchasers to provide services to the manufacturer, such as data 
collection services. These contracts should be structured whenever 
possible to fit in the personal services safe harbor; in all cases, the 
remuneration should be fair market value for legitimate, reasonable, 
and necessary services.
    (b) Formularies and Formulary Support Activities. To help control 
drug costs while maintaining clinical appropriateness and quality of 
patient care, many purchasers of pharmaceutical products, including 
indirect purchasers such as health plans, have developed drug 
formularies to promote rational, clinically appropriate, safe, and 
cost-effective drug therapy. Formularies are a well-established tool 
for the effective management of drug benefits. The formulary 
development process--typically overseen by a committee of physicians, 
pharmacists, and other health care professionals--determines the drugs 
that are covered and, if tiered benefit levels are utilized, to which 
tier the drugs are assigned. So long as the determination of clinical 
efficacy and appropriateness of formulary drugs by the formulary 
committee precedes, and is paramount to, the consideration of costs, 
the development of a formulary is unlikely to raise significant issues 
under the anti-kickback statute.
    Formulary support activities, including related communications with 
patients and physicians to encourage compliance, are an integral and 
essential component of successful pharmacy benefits management. Proper 
utilization of a formulary maximizes the cost-effectiveness of the 
benefit and assures the quality and appropriateness of the drug 
therapy. When provided by a PBM, these services are part of the PBM's 
formulary and benefit management function--a service provided to its 
customers--and markedly different from its purchasing agent/price 
negotiator role. Most importantly, the benefits of these formulary 
support activities inure directly to the PBM and its customers through 
lower costs.
    To date, Medicare and Medicaid involvement with outpatient drug 
formularies has been limited primarily to Medicaid and Medicare managed 
care plans. In light of the safe harbors under the anti-kickback 
statute for those managed care arrangements, the financial arrangements 
between health plans and pharmaceutical manufacturers or, where the 
pharmacy benefit is managed by a PBM, the arrangements among the three 
parties, have received relatively little scrutiny. However, as federal 
program expenditures for, and coverage of, outpatient pharmaceuticals 
increase, scrutiny under the anti-kickback statute has also increased. 
Several practices appear to have the potential for abuse.
    [sbull] Relationships with formulary committee members. Given the 
importance of formulary placement for a manufacturer's products, 
unscrupulous manufacturers and sales representatives may attempt to 
influence committee deliberations. Any remuneration from a manufacturer 
or its agents directly or indirectly to person in a position to 
influence formulary decisions related to the manufacturer's products 
are suspect and should be carefully scrutinized. Manufacturers should 
also review their contacts with sponsors of formularies to ensure that 
price negotiations do not influence decisions on clinical safety or 
efficacy.
    [sbull] Payments to PBMs. Any rebates or other payments by drug 
manufacturers to PBMs that are based on, or otherwise related to, the 
PBM's customers' purchases potentially implicate the anti-kickback 
statute. Protection is available by structuring such arrangements to 
fit in the GPO safe harbor at 42 CFR 1001.952(j). That safe harbor 
requires, among other things, that the payments be authorized in 
advance by the PBM's customer and that all amounts actually paid to the 
PBM on account of the customer's purchases be disclosed in writing at 
least annually to the customer. In addition, arrangements with PBMs 
that assume risk may raise different issues; depending on the 
circumstances, protection for such arrangements may be available under 
the managed care safe harbors at 42 CFR 1001.952(m), (t) and (u).
    [sbull] Formulary placement payments. Lump sum payments for 
inclusion in a formulary or for exclusive or restricted formulary 
status are problematic and should be carefully scrutinized.
    In addition, some manufacturers provide funding for purchasers' or 
PBMs' formulary support activities, especially communications with 
physicians and patients. While the communications may indirectly 
benefit the manufacturer, the primary economic beneficiary is typically 
the formulary sponsor. In other words, the manufacturer's dollars 
appear to replace dollars that would or should be spent by the sponsor. 
To the extent the manufacturers' payments are linked to drug purchases 
directly or indirectly, they potentially implicate the anti-kickback 
statute. Among the questions that should be examined by a manufacturer 
in connection with these activities are: Is the funding tied to 
specific drugs or categories? If so, are the categories especially 
competitive? Is the formulary sponsor funding similar activities for 
other drug categories? Has funding of PBM activities increased as 
rebates are increasingly passed back to PBM customers?
    (c) Average Wholesale Price. The ``spread'' is the difference 
between the amount a customer pays for a product and the amount the 
customer receives upon resale of the product to the patient or other 
payer. In many situations under the federal programs, pharmaceutical 
manufacturers control not only the amount at which they sell a product 
to their customers, but also the amount those customers who purchase 
the product for their own accounts and thereafter bill the federal 
health care programs will be reimbursed. To the extent that a 
manufacturer controls the ``spread,'' it controls its customer's 
profit.

[[Page 23737]]

    Average Wholesale Price (AWP) is the benchmark often used to set 
reimbursement for prescription drugs under the Medicare Part B program. 
For covered drugs and biologicals, Medicare Part B generally reimburses 
at ``95 percent of average wholesale price.'' 42 U.S.C. 1395u(o). 
Similarly many state Medicaid programs and other payers base 
reimbursement for drugs and biologicals on AWP. Generally, AWP or 
pricing information used by commercial price reporting services to 
determine AWP is reported by pharmaceutical manufacturers.
    If a pharmaceutical manufacturer purposefully manipulates the AWP 
to increase its customers' profits by increasing the amount the federal 
health care programs reimburse its customers, the anti-kickback statute 
is implicated. Unlike bona fide discounts, which transfer remuneration 
from a seller to a buyer, manipulation of the AWP transfers 
remuneration to a seller's immediate customer from a subsequent 
purchaser (the federal or state government). Under the anti-kickback 
statute, offering remuneration to a purchaser or referral source is 
improper if one purpose is to induce the purchase or referral of 
program business. In other words, it is illegal for a manufacturer 
knowingly to establish or inappropriately maintain a particular AWP if 
one purpose is to manipulate the ``spread'' to induce customers to 
purchase its product.
    In the light of this risk, we recommend that manufacturers review 
their AWP reporting practices and methodology to confirm that marketing 
considerations do not influence the process. Furthermore, manufacturers 
should review their marketing practices. The conjunction of 
manipulation of the AWP to induce customers to purchase a product with 
active marketing of the spread is strong evidence of the unlawful 
intent necessary to trigger the anti-kickback statute. Active marketing 
of the spread includes, for example, sales representatives promoting 
the spread as a reason to purchase the product or guaranteeing a 
certain profit or spread in exchange for the purchase of a product.
    (2) Relationships with Physicians and Other Persons and Entities in 
a Position to Make or Influence Referrals. Pharmaceutical manufacturers 
and their agents may have a variety of remunerative relationships with 
persons or entities in a position to refer, order, or prescribe--or 
influence the referral, ordering, or prescribing of--the manufacturers' 
products, even though the persons or entities may not themselves 
purchase (or in the case of GPOs or PBMs, arrange for the purchase of) 
those products. These remunerative relationships potentially implicate 
the anti-kickback statute. The following discussion focuses on 
relationships with physicians, but the same principles would apply when 
evaluating relationships with other parties in a position to influence 
referrals, including, without limitation, pharmacists and other health 
care professionals.
    Manufacturers, providers, and suppliers of health care products and 
services frequently cultivate relationships with physicians in a 
position to generate business for them through a variety of practices, 
including gifts, entertainment, and personal services compensation 
arrangements. These activities have a high potential for fraud and 
abuse and, historically, have generated a substantial number of anti-
kickback convictions. There is no substantive difference between 
remuneration from a pharmaceutical manufacturer or from a durable 
medical equipment or other supplier--if the remuneration is intended to 
generate any federal health care business, it potentially violates the 
anti-kickback statute.
    Any time a pharmaceutical manufacturer provides anything of value 
to a physician who might prescribe the manufacturer's product, the 
manufacturer should examine whether it is providing a valuable tangible 
benefit to the physician with the intent to induce or reward referrals. 
For example, if goods or services provided by the manufacturer 
eliminate an expense that the physician would have otherwise incurred 
(i.e., have independent value to the physician), or if items or 
services are sold to a physician at less than their fair market value, 
the arrangement may be problematic if the arrangement is tied directly 
or indirectly to the generation of federal health care program business 
for the manufacturer. Moreover, under the anti-kickback statute, 
neither a legitimate purpose for an arrangement (e.g., physician 
education), nor a fair market value payment, will necessarily protect 
remuneration if there is also an illegal purpose (i.e., the purposeful 
inducement of business).
    In light of the obvious risks inherent in these arrangements, 
whenever possible prudent manufacturers and their agents or 
representatives should structure relationships with physicians to fit 
in an available safe harbor, such as the safe harbors for personal 
services and management contracts, 42 CFR 1001.952(d), or employees, 42 
CFR 1001.952(i). An arrangement must fit squarely in a safe harbor to 
be protected. In addition, arrangements that do not fit in a safe 
harbor should be reviewed in light of the totality of all facts and 
circumstances, bearing in mind the following factors, among others:
    [sbull] Nature of the relationship between the parties. What degree 
of influence does the physician have, directly or indirectly, on the 
generation of business for the manufacturer? Does the manufacturer have 
other direct or indirect relationships with the physician or members of 
the physician's group?
    [sbull] Manner in which the remuneration is determined. Does the 
remuneration take into account, directly or indirectly, the volume or 
value of business generated (e.g., is the remuneration only given to 
persons who have prescribed or agreed to prescribe the manufacturer's 
product)? Is the remuneration conditioned in whole or in part on 
referrals or other business generated? Is there any service provided 
other than referrals?
    [sbull] Value of the remuneration. Is the remuneration more than 
trivial in value, including all gifts to any individual, entity, or 
group of individuals? \10\ Do fees for services exceed the fair market 
value of any legitimate, reasonable, and necessary services rendered by 
the physician to the manufacturer?
    [sbull] Potential federal program impact of the remuneration. Does 
the remuneration have the potential to affect costs to any of the 
federal health care programs or their beneficiaries or to lead to 
overutilization or inappropriate utilization?
    [sbull] Potential conflicts of interest. Would acceptance of the 
remuneration diminish, or appear to diminish, the objectivity of 
professional judgment? Are there patient safety or quality of care 
concerns? If the remuneration relates to the dissemination of 
information, is the information complete, accurate, and not misleading?
    These concerns are addressed in the PhRMA Code on Interactions with 
Healthcare Professionals (the ``PhRMA Code''), adopted on April 18, 
2002, which provides useful and practical advice for reviewing and 
structuring these relationships. (The PhRMA Code is available through 
PhRMA's Web site at http://www.phrma.org.) Although compliance with the 
PhRMA Code will not protect a manufacturer as a matter of law under the 
anti-kickback statute, it will substantially reduce the risk of fraud 
and abuse and help demonstrate a good faith effort to comply with the 
applicable federal health care program requirements.

[[Page 23738]]

    The following paragraphs discuss in greater detail several common 
or problematic relationships between manufacturers and physicians, 
including ``switching'' arrangements, consulting and advisory payments, 
payments for detailing, business courtesies and other gratuities, and 
educational and research activities.
    [sbull] Switching'' arrangements. As noted in the OIG's 1994 
Special Fraud Alert (59 FR 65372; December 19, 1994), product 
conversion arrangements (also known as ``switching'' arrangements) are 
suspect under the anti-kickback statute. Switching arrangements involve 
pharmaceutical manufacturers offering physicians or others cash 
payments or other benefits each time a patient's prescription is 
changed to the manufacturer's product from a competing product. This 
activity clearly implicates the statute, and, while such programs may 
be permissible in certain managed care arrangements, manufacturers 
should review very carefully any marketing practices utilizing 
``switching'' payments in connection with products reimbursable by 
federal health care programs.
    Consulting and advisory payments. Pharmaceutical manufacturers 
frequently engage physicians and other health care professionals to 
furnish personal services as consultants or advisers to the 
manufacturer. In general, fair market value payments to small numbers 
of physicians for bona fide consulting or advisory services are 
unlikely to raise any significant concern. Compensating physicians as 
``consultants'' when they are expected to attend meetings or 
conferences primarily in a passive capacity is suspect.
    Also of concern are compensation relationships with physicians for 
services connected directly or indirectly to a manufacturer's marketing 
and sales activities, such as speaking, certain research, or preceptor 
or ``shadowing'' services. While these arrangements are potentially 
beneficial, they also pose a risk of fraud and abuse. In particular, 
the use of health care professionals for marketing purposes--including, 
for example, ghost-written papers or speeches--implicates the anti-
kickback statute. While full disclosure by physicians of any potential 
conflicts of interest and of industry sponsorship or affiliation may 
reduce the risk of abuse, disclosure does not eliminate the risk.
    At a minimum, manufacturers should periodically review arrangements 
for physicians' services to ensure that: (i) The arrangement is set out 
in writing; (ii) there is a legitimate need for the services; (iii) the 
services are provided; (iv) the compensation is at fair market value; 
and (v) all of the preceding facts are documented prior to payment. In 
addition, to further reduce their risk, manufacturers should structure 
services arrangements to comply with a safe harbor whenever possible.
    Payments for detailing. Recently, some entities have been 
compensating physicians for time spent listening to sales 
representatives market pharmaceutical products. In some cases, these 
payments are characterized as ``consulting'' fees and may require 
physicians to complete minimal paperwork. Other companies pay 
physicians for time spent accessing web sites to view or listen to 
marketing information or perform ``research.'' All of these activities 
are highly suspect under the anti-kickback statute, are highly 
susceptible to fraud and abuse, and should be strongly discouraged.
    Business Courtesies and Other Gratuities. Pharmaceutical companies 
and their employees and agents often engage in a number of other 
arrangements that offer benefits, directly or indirectly, to physicians 
or others in a position to make or influence referrals. Examples of 
remunerative arrangements between pharmaceutical manufacturers (or 
their representatives) and parties in a position to influence referrals 
include:
    [sbull] Entertainment, recreation, travel, meals, or other benefits 
in association with information or marketing presentations; and
    [sbull] Gifts, gratuities, and other business courtesies.
    As discussed above, these arrangements potentially implicate the 
anti-kickback statute if any one purpose of the arrangement is to 
generate business for the pharmaceutical company. While the 
determination of whether a particular arrangement violates the anti-
kickback statute depends on the specific facts and circumstances, 
compliance with the PhRMA Code with respect to these arrangements 
should substantially reduce a manufacturer's risk.
    Educational and Research Funding. In some cases, manufacturers 
contract with physicians to provide research services on a fee-for-
service basis. These contracts should be structured to fit in the 
personal services safe harbor whenever possible. Payments for research 
services should be fair market value for legitimate, reasonable, and 
necessary services. Research contracts that originate through the sales 
or marketing functions--or that are offered to physicians in connection 
with sales contacts--are particularly suspect. Indicia of questionable 
research include, for example, research initiated or directed by 
marketers or sales agents; research that is not transmitted to, or 
reviewed by, a manufacturer's science component; research that is 
unnecessarily duplicative or is not needed by the manufacturer for any 
purpose other than the generation of business; and post-marketing 
research used as a pretense to promote product. Prudent manufacturers 
will develop contracting procedures that clearly separate the awarding 
of research contracts from marketing or promotion of their products.
    In addition, pharmaceutical manufacturers also provide other 
funding for a wide range of physician educational and research 
activities. Manufacturers should review educational and research grants 
to physicians similarly to educational and research grants to 
purchasers (described above). As with grants to purchasers, the OIG 
recognizes that many grant-funded activities are legitimate and 
beneficial. When evaluating educational or research grants provided by 
manufacturers to physicians, manufacturers should determine if the 
funding is based, in any way, expressly or implicitly, on the 
physician's referral of the manufacturer's product. If so, the funding 
plainly implicates the anti-kickback statute. In addition, the 
manufacturer should determine whether the funding is for bona fide 
educational or research purposes. Absent unusual circumstances, grants 
or support for educational activities sponsored and organized by 
medical professional organizations raise little risk of fraud or abuse, 
provided that the grant or support is not restricted or conditioned 
with respect to content or faculty.
    Pharmaceutical manufacturers often provide funding to other 
sponsors of continuing medical education (CME) programs. Manufacturers 
should take steps to ensure that neither they, nor their 
representatives, are using these activities to channel improper 
remuneration to physicians or others in a position to generate business 
for the manufacturer or to influence or control the content of the 
program.\11\ In addition, manufacturers and sponsors of educational 
programs should be mindful of the relevant rules and regulations of the 
Food and Drug Administration. Codes of conduct promulgated by the CME 
industry may provide a useful starting point for manufacturers when 
reviewing their CME arrangements.
    (3) Relationships with Sales Agents. In large part, a 
pharmaceutical manufacturer's commitment to an effective fraud and 
abuse compliance program can be measured by its

[[Page 23739]]

commitment to training and monitoring its sales force. A pharmaceutical 
manufacturer should: (i) Develop a regular and comprehensive training 
program for its sales force, including refresher and updated training 
on a regular basis, either in person or through newsletters, memoranda, 
or the like; (ii) familiarize its sales force with the minimum PhRMA 
Code standards and other relevant industry standards; (iii) institute 
and implement corrective action and disciplinary policies applicable to 
sales agents who engage in improper marketing; (iv) avail itself of the 
advisory opinion process if it has questions about particular practices 
used by its sales force; and (v) establish an effective system for 
tracking, compiling, and reviewing information about sales force 
activities, including, if appropriate, random spot checking.
    In addition, manufacturers should carefully review their 
compensation arrangements with sales agents. Sales agents, whether 
employees or independent contractors, are paid to recommend and arrange 
for the purchase of the items or services they offer for sale on behalf 
of the pharmaceutical manufacturer they represent. Many arrangements 
can be structured to fit in the employment or personal services safe 
harbor. Arrangements that cannot fit into a safe harbor should be 
carefully reviewed. Among the factors that should be evaluated are:
    [sbull] The amount of compensation;
    [sbull] The identity of the sales agent engaged in the marketing or 
promotional activity (e.g., is the agent a ``white coat'' marketer or 
otherwise in a position of exceptional influence);
    [sbull] The sales agent's relationship with his or her audience;
    [sbull] The nature of the marketing or promotional activity;
    [sbull] The item or service being promoted or marketed; and
    [sbull] The composition of the target audience.
    Manufacturers should be aware that a compensation arrangement with 
a sales agent that fits in a safe harbor can still be evidence of a 
manufacturer's improper intent when evaluating the legality of the 
manufacturer's relationships with persons in a position to influence 
business for the manufacturer. For example, if a manufacturer provides 
sales employees with extraordinary incentive bonuses and expense 
accounts, there may well be an inference to be drawn that the 
manufacturer intentionally motivated the sales force to induce sales 
through lavish entertainment or other remuneration.
    c. Drug Samples. The provision of drug samples is a widespread 
industry practice that can benefit patients, but can also be an area of 
potential risk to a pharmaceutical manufacturer. The Prescription Drug 
Marketing Act of 1987 (PDMA) governs the distribution of drug samples 
and forbids their sale. 21 U.S.C. 353(c)(1). A drug sample is defined 
to be a unit of the drug ``that is not intended to be sold * * * and is 
intended to promote the sale of the drug.'' 21 U.S.C. 353(c)(1). 
Failure to comply with the requirements of PDMA can result in 
sanctions. In some circumstances, if the samples have monetary value to 
the recipient (e.g., a physician) and are used to treat federal health 
care program beneficiaries, the improper use of samples may also 
trigger liability under other statutes, including the False Claims Act 
and the anti-kickback statue.
    Pharmaceutical manufacturers should closely follow the PDMA 
requirements (including all documentation requirements). In addition, 
manufacturers can minimize their risk of liability by: (i) Training 
their sales force to inform sample recipients in a meaningful manner 
that samples may not be sold or billed (thus vitiating any monetary 
value of the sample); (ii) clearly and conspicuously labeling 
individual samples as units that may not be sold (thus minimizing the 
ability of recipients to advertently or inadvertently commingle samples 
with purchased product); and (iii) including on packaging and any 
documentation related to the samples (such as shipping notices or 
invoices) a clear and conspicuous notice that the samples are subject 
to PDMA and may not be sold. Recent government enforcement activity has 
focused on instances in which drug samples were provided to physicians 
who, in turn, sold them to the patient or billed them to the federal 
health care programs on behalf of the patient.

C. Designation of a Compliance Officer and a Compliance Committee

1. Compliance Officer
    Every pharmaceutical manufacturer should designate a compliance 
officer to serve as the focal point for compliance activities.\12\ This 
responsibility may be the individual's sole duty or added to other 
management responsibilities, depending upon the size and resources of 
the company and the complexity of the task. If the individual has 
additional management responsibilities, the pharmaceutical manufacturer 
should ensure that the individual is able to dedicate adequate and 
substantive time and attention to the compliance functions. Similarly, 
if the compliance officer delegates some of the compliance duties, he 
or she should, nonetheless, remain sufficiently involved to fulfill the 
compliance oversight function.
    Designating a compliance officer with the appropriate authority is 
critical to the success of the program, necessitating the appointment 
of a high-level official with direct access to the company's president 
or CEO, board of directors, all other senior management, and legal 
counsel. The compliance officer should have sufficient funding, 
resources, and staff to perform his or her responsibilities fully. The 
compliance officer should be able to effectuate change within the 
organization as necessary or appropriate and to exercise independent 
judgment. Optimal placement of the compliance officer within the 
organization will vary according to the particular situation of a 
manufacturer.\13\
    Coordination and communication with other appropriate individuals 
or business units are the key functions of the compliance officer with 
regard to planning, implementing or enhancing, and monitoring the 
compliance program. The compliance officer's primary responsibilities 
should include:
    [sbull] Overseeing and monitoring implementation of the compliance 
program; \14\
    [sbull] Reporting on a regular basis to the company's board of 
directors, CEO or president, and compliance committee (if applicable) 
on compliance matters and assisting these individuals or groups to 
establish methods to reduce the company's vulnerability to fraud and 
abuse;
    [sbull] Periodically revising the compliance program, as 
appropriate, to respond to changes in the company's needs and 
applicable federal health care program requirements, identified 
weakness in the compliance program, or identified systemic patterns of 
noncompliance;
    [sbull] Developing, coordinating, and participating in a 
multifaceted educational and training program that focuses on the 
elements of the compliance program, and seeking to ensure that all 
affected employees and management understand and comply with pertinent 
federal and state standards;
    [sbull] Ensuring that independent contractors and agents, 
particularly those agents and contractors who are involved in sales and 
marketing activities, are aware of the requirements of the company's 
compliance program with respect to sales and marketing activities, 
among other things;
    [sbull] Coordinating personnel issues with the company's Human 
Resources/

[[Page 23740]]

Personnel office (or its equivalent) to ensure that the List of 
Excluded Individuals/Entities \15\ has been checked with respect to all 
employees and independent contractors;
    [sbull] Assisting the company's internal auditors in coordinating 
internal compliance review and monitoring activities;
    [sbull] Reviewing and, where appropriate, acting in response to 
reports of noncompliance received through the hotline (or other 
established reporting mechanism) or otherwise brought to his or her 
attention (e.g., as a result of an internal audit or by corporate 
counsel who may have been notified of a potential instance of 
noncompliance);
    [sbull] Independently investigating and acting on matters related 
to compliance. To that end, the compliance officer should have 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 
policies and practices, and taking appropriate disciplinary action) 
with various company divisions or departments;
    [sbull] Participating with the company's counsel in the appropriate 
reporting of any self-discovered violations of federal health care 
program requirements; and
    [sbull] Continuing the momentum and, as appropriate, revision or 
expansion of the compliance program after the initial years of 
implementation.\16\
    The compliance officer must have the authority to review all 
documents and other information relevant to compliance activities. This 
review authority should enable the compliance officer to examine 
interactions with government programs to determine whether the company 
is in compliance with federal health care program reporting and rebate 
requirements and to examine interactions with health care professionals 
that could violate kickback prohibitions or other federal health care 
programs requirements. Where appropriate, the compliance officer should 
seek the advice of competent legal counsel about these matters.
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.\17\ When developing an appropriate team of people 
to serve as the pharmaceutical manufacturer's compliance committee, the 
company should consider a variety of skills and personality traits that 
are expected from the team members. The company 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 company employees. These 
interpersonal skills are as important as the professional experience of 
the compliance officer and each member of the compliance committee.
    Once a pharmaceutical manufacturer chooses the people who will 
accept the responsibilities vested in members of the compliance 
committee, the company needs to train these individuals on the policies 
and procedures of the compliance program, as well as how to discharge 
their duties. The OIG recognizes that some pharmaceutical manufacturers 
(e.g., small companies or those with limited budgets) may not have the 
resources or the need to establish a compliance committee. However, 
when potential problems are identified at such companies, the OIG 
recommends the creation of a ``task force'' to address the particular 
issues. The members of the task force may vary depending upon the area 
of concern. For example, if the compliance officer identifies issues 
relating to improper inducements to the company's purchasers or 
prescribers, the OIG recommends that a task force be organized to 
review the arrangements and interactions with those purchasers or 
prescribers. In essence, the compliance committee is an extension of 
the compliance officer and provides the organization with increased 
oversight.

D. Conducting Effective Training and Education

    The proper education and training of officers, directors, 
employees, contractors, and agents, and periodic retraining of 
personnel at all levels are critical elements of an effective 
compliance program. A pharmaceutical manufacturer must take steps to 
communicate effectively its standards and procedures to all affected 
personnel by requiring participation in appropriate training programs 
and by other means, such as disseminating publications that explain 
specific requirements in a practical manner. These training programs 
should include general sessions summarizing the manufacturer's 
compliance program, written standards, and applicable federal health 
care program requirements. All employees and, where feasible and 
appropriate, contractors should receive the general training. More 
specific training on issues, such as (i) the anti-kickback statute and 
how it applies to pharmaceutical sales and marketing practices and (ii) 
the calculation and reporting of pricing information and payment of 
rebates in connection with federal health care programs, should be 
targeted at those employees and contractors whose job requirements make 
the information relevant. The specific training should be tailored to 
make it as meaningful as possible for each group of participants.
    Managers and employees of specific divisions can assist in 
identifying specialized areas that require training and in carrying out 
such training. Additional areas for training may also be identified 
through internal audits and monitoring and from a review of any past 
compliance problems of the pharmaceutical manufacturer or similarly 
situated companies. A pharmaceutical manufacturer should regularly 
review its training and, where appropriate, update the training to 
reflect issues identified through audits or monitoring and any relevant 
changes in federal health care program requirements. Training 
instructors may come from outside or inside the organization, but must 
be qualified to present the subject matter involved and sufficiently 
experienced in the issues presented to adequately field questions and 
coordinate discussions among those being trained. Ideally, training 
instructors should be available for follow-up questions after the 
formal training session has been conducted.
    The pharmaceutical manufacturer should train new employees soon 
after they have started working. 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 company as part of the compliance 
program. The company should retain adequate records of its training of 
employees, including attendance logs, descriptions of the training 
sessions, and copies of the material distributed at training sessions.
    The OIG suggests that all relevant personnel (i.e., employees as 
well as agents of the pharmaceutical manufacturer) participate in the 
various educational and training programs of the company. For example, 
for sales representatives who are responsible for the sale and 
marketing of the company's products, periodic training in the anti-
kickback statute and its safe harbors should be required. Employees 
should be required to have a minimum number of educational hours per 
year, as appropriate, as part of their employment responsibilities.

[[Page 23741]]

    The OIG recognizes that the format of the training program will 
vary depending upon the size and resources of the pharmaceutical 
manufacturer. For example, a company with limited resources or whose 
sales force is widely dispersed may want to create a videotape or 
computer-based program for each type of training session so new 
employees and employees outside of central locations can receive 
training in a timely manner. If videos or computer-based programs are 
used for compliance training, the OIG suggests that the company make a 
qualified individual available to field questions from trainees. Also, 
large pharmaceutical manufacturers may find training via the Internet 
or video conference capabilities to be a cost-effective means of 
reaching a large number of employees. Alternatively, large companies 
may include training sessions as part of regularly scheduled regional 
meetings.
    The OIG recommends that participation in training programs be made 
a condition of continued employment and that failure to comply with 
training requirements should result in disciplinary action. Adherence 
to the training requirements as well as other provisions of the 
compliance program should be a factor in the annual evaluation of each 
employee.

E. Developing Effective Lines of Communication

1. Access to Supervisors and/or the Compliance Officer
    In order for a compliance program to work, employees must be able 
to ask questions and report problems. Supervisors play a key role in 
responding to employee concerns and it is appropriate that they serve 
as a first line of communications. Pharmaceutical manufacturers should 
consider the adoption of open-door policies in order to foster dialogue 
between management and employees. In order to encourage communications, 
confidentiality and non-retaliation policies should also be developed 
and distributed to all employees.\18\
    Open lines of communication between the compliance officer and 
employees are equally important to the successful implementation of a 
compliance program and the reduction of any potential for fraud and 
abuse. In addition to serving as a contact point for reporting problems 
and initiating appropriate responsive action, the compliance officer 
should be viewed as someone to whom personnel can go to get 
clarification on the company's policies. Questions and responses should 
be documented and dated and, if appropriate, shared with other staff so 
that compliance standards or polices can be updated and improved to 
reflect any necessary changes or clarifications. Pharmaceutical 
manufacturers may also consider rewarding employees for appropriate use 
of established reporting systems as a way to encourage the use of such 
systems.
2. Hotlines and Other Forms of Communication
    The OIG encourages the use of hotlines, e-mails, newsletters, 
suggestion boxes, and other forms of information exchange to maintain 
open lines of communication. In addition, an effective employee exit 
interview program could be designed to solicit information from 
departing employees regarding potential misconduct and suspected 
violations of company policy and procedures. Pharmaceutical 
manufacturers may also identify areas of risk or concern through 
periodic surveys or communications with sales representatives about the 
current marketing environment. This could provide management with 
insight about and an opportunity to address conduct occurring in the 
field, either by the company's own sale representatives or those of 
other companies.
    If a pharmaceutical manufacturer establishes a hotline or other 
reporting mechanism, information regarding how to access the reporting 
mechanism should be made readily available to all employees and 
independent contractors by including that information in the code of 
conduct or by circulating the information (e.g., by publishing the 
hotline number or e-mail address on wallet cards) or conspicuously 
posting the information in common work areas. Employees should be 
permitted to report matters on an anonymous basis.
    Reported matters that suggest substantial violations of compliance 
policies or applicable Federal health care program requirements should 
be documented and investigated promptly to determine their veracity and 
the scope and cause of any underlying problem. The compliance officer 
should maintain a detailed log that records such reports, including the 
nature of any investigation, its results, and any remedial or 
disciplinary action taken. Such information, redacted of individual 
identifiers, should be summarized and included in reports to the board 
of directors, the president or CEO, and compliance committee. Although 
the pharmaceutical manufacturer should always strive to maintain the 
confidentiality of an employee's identity, it should also make clear 
that there might be a point where the individual's identity may become 
known or need to be revealed in certain instances. The OIG recognizes 
that protecting anonymity may be infeasible for small companies. 
However, the OIG believes all employees, when seeking answers to 
questions or reporting potential instances of fraud and abuse, should 
know to whom to turn for a meaningful response and should be able to do 
so without fear of retribution.

F. Auditing and Monitoring

    An effective compliance program should incorporate thorough 
monitoring of its implementation and an ongoing evaluation process. The 
compliance officer should document this ongoing monitoring, including 
reports of suspected noncompliance, and provide these assessments to 
company's senior management and the compliance committee. The extent 
and frequency of the compliance audits may vary depending on variables 
such as the pharmaceutical manufacturer's available resources, prior 
history of noncompliance, and the risk factors particular to the 
company. The nature of the reviews may also vary and could include a 
prospective systemic review of the manufacturer's processes, protocols, 
and practices or a retrospective review of actual practices in a 
particular area.
    Although many assessment techniques are available, it is often 
effective to have internal or external evaluators who have relevant 
expertise perform regular compliance reviews. The reviews should focus 
on those divisions or departments of the pharmaceutical manufacturer 
that have substantive involvement with or impact on federal health care 
programs (such as the government contracts and sales and marketing 
divisions) and on the risk areas identified in this guidance. The 
reviews should also evaluate the company's policies and procedures 
regarding other areas of concern identified by the OIG (e.g., through 
Special Fraud Alerts) and federal and state law enforcement agencies. 
Specifically, the reviews should evaluate whether the: (1) 
Pharmaceutical manufacturer has policies covering the identified risk 
areas; (2) policies were implemented and communicated; and (3) policies 
were followed.

G. Enforcing Standards Through Well-Publicized Disciplinary Guidelines

    An effective compliance program should include clear and specific 
disciplinary policies that set out the consequences of violating the 
law or the pharmaceutical manufacturer's code of

[[Page 23742]]

conduct or policies and procedures. A pharmaceutical manufacturer 
should consistently undertake appropriate disciplinary action across 
the company in order for the disciplinary policy to have the required 
deterrent effect. Intentional and material noncompliance should subject 
transgressors to significant sanctions. Such sanctions could range from 
oral warnings to suspension, termination or other sanctions, as 
appropriate. Disciplinary action also may be appropriate where a 
responsible employee's failure to detect a violation is attributable to 
his or her negligence or reckless conduct. Each situation must be 
considered on a case-by-case basis, taking into account all relevant 
factors, to determine the appropriate response.

H. Responding to Detected Problems and Developing Corrective Action 
Initiatives

    Violation of a pharmaceutical manufacturer's compliance program, 
failure to comply with applicable federal or state law, and other types 
of misconduct threaten the company's status as a reliable, honest, and 
trustworthy participant in the health care industry. Detected but 
uncorrected misconduct can endanger the reputation and legal status of 
the company. Consequently, upon receipt of reasonable indications of 
suspected noncompliance, it is important that the compliance officer or 
other management officials immediately investigate the allegations 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.\19\ The exact nature and level 
of thoroughness of the investigation will vary according to the 
circumstances, but the review should be detailed enough to identify the 
root cause of the problem. As appropriate, the investigation may 
include a corrective action plan, a report and repayment to the 
government, and/or a referral to criminal and/or civil law enforcement 
authorities.

Reporting

    Where the compliance officer, compliance committee, or a member of 
senior management discovers credible evidence of misconduct from any 
source and, after a reasonable inquiry, believes that the misconduct 
may violate criminal, civil, or administrative law, the company should 
promptly report the existence of misconduct to the appropriate federal 
and state authorities\20\ within a reasonable period, but not more than 
60 days,\21\ after determining that there is credible evidence of a 
violation.\22\ Prompt voluntary reporting will demonstrate the 
pharmaceutical manufacturer'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 company becomes the 
subject of an OIG investigation.\23\
    When reporting to the government, a pharmaceutical manufacturer 
should provide all information relevant to the alleged violation of 
applicable federal or state law(s) and the potential financial or other 
impact of the alleged violation. 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, and especially if the investigation 
ultimately reveals that criminal, civil or administrative violations 
have occurred, the compliance officer should 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 federal health care programs or their beneficiaries.

III. Conclusion

    In today's environment of increased scrutiny of corporate conduct 
and increasingly large expenditures for prescription drugs, it is 
imperative for pharmaceutical manufacturers to establish and maintain 
effective compliance programs. These programs should foster a culture 
of compliance that begins at the executive level and permeates 
throughout the organization. This compliance guidance is designed to 
provide assistance to all pharmaceutical manufacturers as they either 
implement compliance programs or re-assess existing programs. The 
essential elements outlined in this compliance guidance can be adapted 
to the unique environment of each manufacturer. It is the hope and 
expectation of the OIG that the resulting compliance programs will 
benefit not only federal health care programs and their beneficiaries, 
but also pharmaceutical manufacturers themselves.

    Dated: April 23, 2003.
Janet Rehnquist,
Inspector General.

Endnotes

    1. The term ``Federal health care programs,'' as defined in 42 
U.S.C. 1320a-7b(f), 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 or any state health plan (e.g., Medicaid or a program 
receiving funds from block grants for social services or child 
health services). In this document, the term ``federal health care 
program requirements'' refers to the statutes, regulations and other 
rules governing Medicare, Medicaid, and all other federal health 
care programs.
    2. See 66 FR 31246 (June 11, 2001), ``Notice for Solicitation of 
Information and Recommendations for Developing a Compliance Program 
Guidance for the Pharmaceutical Industry.''
    3. See 67 FR 62057 (October 3, 2002), ``Draft OIG Compliance 
Program Guidance for Pharmaceutical Manufacturers.''
    4. 42 U.S.C. 1320a-7b(b).
    5. In addition, the compliance program elements and potential 
risk areas addressed in this compliance program guidance may also 
have application to manufacturers of other products that may be 
reimbursed by federal health care programs, such as medical devices 
and infant nutritional products.
    6. In addition, pharmaceutical manufacturers should be mindful 
that many states have fraud and abuse statutes--including false 
claims, anti-kickback and other statutes--that are not addressed in 
this guidance.
    7. The False Claims Act (31 U.S.C. 3729-33) prohibits knowingly 
presenting (or causing to be presented) to the federal government a 
false or fraudulent claim for payment or approval. Additionally, it 
prohibits knowingly making or using (or causing to be made or used) 
a false record or statement to get a false or fraudulent claim paid 
or approved by the federal government or its agents, like a carrier, 
other claims processor, or state Medicaid program.
    8. The 340B Program, contained as part of the Public Health 
Services Act and codified at 42 U.S.C. 256b, is administered by the 
Health Resources and Services Administration (HRSA).
    9. 42 U.S.C. 1396r-8. Average Manufacturer Price and Best Price 
are defined in the statute at 42 U.S.C. 1396r-8(k)(1) and 1396r-
8(c)(1), respectively. CMS has provided further guidance on these 
terms in the National Drug Rebate Agreement and in Medicaid Program 
Releases available through its Web site at http://www.hcfa.gov/medicaid/drugs/drug.mpg.htm.
    10. In this regard, pharmaceutical manufacturers should note 
that the exception for non-monetary compensation under the Stark law 
(42 U.S.C. 1395nn; 42 CFR 411.357(k)) is not a basis for protection 
under the anti-kickback statute.
    11. CME programs with no industry sponsorship, financing, or 
affiliation should not raise anti-kickback concerns, although 
tuition payments by manufacturers (or their representatives) for 
persons in a position to influence referrals (e.g., physicians or 
medical students) may raise concerns.
    12. It is also advisable to designate as a compliance officer an 
individual with prior experience or knowledge of compliance and

[[Page 23743]]

operational issues relevant to pharmaceutical manufacturers.
    13. The OIG believes it is generally not advisable for the 
compliance function to be subordinate to the pharmaceutical 
manufacturer's general counsel, or comptroller or similar financial 
officer. Separation of the compliance function helps to ensure 
independent and objective legal reviews and financial analysis of 
the company'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 pharmaceutical manufacturer make this a feasible option), a 
system of checks and balances is established to more effectively 
achieve the goals of the compliance program.
    14. For companies with multiple divisions or regional offices, 
the OIG encourages coordination with each company location through 
the use of a compliance officer located in corporate headquarters 
who is able to communicate with parallel compliance liaisons in each 
division or regional office, as appropriate.
    15. As part of its commitment to compliance, a pharmaceutical 
manufacturer should carefully consider whether to hire or do 
business with individuals or entities that have been sanctioned by 
the OIG. The List of Excluded Individuals and Entities can be 
checked electronically and is accessible through the OIG's Web site 
at: http://oig.hhs.gov.
    16. There are many approaches the compliance officer may enlist 
to maintain the vitality of the compliance program. Periodic on-site 
visits of regional operations, bulletins with compliance updates and 
reminders, distribution of audiotapes, videotapes, CD ROMs, or 
computer notifications about different risk areas, lectures at 
management and employee meetings, and circulation of recent articles 
or publications discussing fraud and abuse are some examples of 
approaches the compliance officer may employ.
    17. The compliance committee benefits from having the 
perspectives of individuals with varying responsibilities and areas 
of knowledge in the organization, such as operations, finance, 
audit, human resources, legal, and sales and marketing, as well as 
employees and managers of key operating units. The compliance 
officer should be an integral member of the committee. All committee 
members should have the requisite seniority and comprehensive 
experience within their respective departments to recommend and 
implement any necessary changes to policies and procedures.
    18. In some cases, employees sue their employers under the False 
Claims Act's qui tam provisions after a failure or apparent failure 
by the company to take action when the employee brought a 
questionable, fraudulent, or abusive situation to the attention of 
senior corporate officials. Whistleblowers must be protected against 
retaliation, a concept embodied in the provisions of the False 
Claims Act. See 31 U.S.C. 3730(h).
    19. Instances of noncompliance must be determined on a case-by-
case basis. The existence or amount of a monetary loss to a federal 
health care program is not solely determinative of whether the 
conduct should be investigated and reported to governmental 
authorities. In fact, there may be instances where there is no 
readily identifiable monetary loss, but corrective actions are still 
necessary to protect the integrity of the health care program.
    20. Appropriate federal and state authorities include the OIG, 
the Criminal and Civil Divisions of the Department of Justice, the 
U.S. Attorney in relevant districts, the Food and Drug 
Administration, the Federal Trade Commission, the Drug Enforcement 
Administration and the Federal Bureau of Investigation, 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, the 
Department of Veterans Affairs, HRSA, and the Office of Personnel 
Management (which administers the Federal Employee Health Benefits 
Program).
    21. In contrast, to qualify for the ``not less than double 
damages'' provision of the False Claims Act, the provider must 
provide the report to the government within 30 days after the date 
when the provider first obtained the information. 31 U.S.C. 3729(a).
    22. Some violations may be so serious that they warrant 
immediate notification to governmental authorities prior to, or 
simultaneous with, commencing an internal investigation. By way of 
example, the OIG believes a provider should report misconduct that: 
(1) Is a clear violation of administrative, civil, or criminal laws; 
(2) has a significant adverse effect on the quality of care provided 
to federal health care program beneficiaries; 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.
    23. The OIG has published criteria setting forth those factors 
that the OIG takes into consideration in determining whether it is 
appropriate to exclude an individual or entity 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 (December 24, 1997).

[FR Doc. 03-10949 Filed 5-2-03; 8:45 am]
BILLING CODE 4152-01-P