Recommendations to Members on Industry Relations:

NAPNAP provides members with guidance on working with industry sponsors. To review the recommendations created by NAPNAP's Washington Representatives and approved by the NAPNAP Executive Board, please see below.

I. Introduction

Relations between health care providers and pharmaceutical, medical device, and medical supply companies are being examined closely by the government and even targeted by enforcement authorities. Recent government enforcement developments, particularly the TAP Pharmaceuticals investigation, are causing many health care providers to reevaluate their relationships with pharmaceutical and device manufacturers and other vendors.

The DIG intends to focus on what it estimates to be $12 billion annually spent by the drug companies on "physician detailing." In particular, the DIG has expressed concern about drug companies providing anything of value to health care providers as an inducement to order their products. In the view of the DIG, such conduct creates both inherent conflicts of interest as well as kickback violations. The TAP investigation, for example, centered largely around the company's sales and marketing practices. At least nineteen TAP employees, including the vice president and several sales representatives, were indicted on charges of defrauding the federal health care programs by causing free samples of Lupron to be billed to the Medicare and Medicaid programs, and illegally inducing physicians to order the company's product, Lupron. In addition, at least four physician-customers have pleaded guilty to fraud arising from the investigation against TAP.

The members of the National Association of Pediatric Nurse Practitioners (NAPNAP) are leaders in their field. While nurse practitioners have not yet been the direct target of a government investigation, as providers with prescriptive authority, NPs are increasingly becoming recognized as highly desirable customers from the perspective of industry, and it is reasonable to expect that it is only a matter of time until NPs will be targets, whether directly or indirectly, for aggressive competitors and enforcement authorities. NAPNAP believes, therefore, that it is prudent and advisable for its members to give serious thought and consideration to their own interactions with industry. Even if a given activity is not clearly illegal or unethical, the appearance of impropriety or a conflict of interest can result in unnecessary and expensive inquiries. Moreover, even the appearance of a conflict of interest can diminish patients' perception of, and confidence in, their health care provider, and, thus, should be avoided. The NAPNAP Board of Directors as well as many NAPNAP members, acting with tremendous foresight and an abundance of caution, asked for recommendations on how to appropriately interact with industry and avoid accusations of impropriety.

NAPNAP remains mindful, however, of the many socially beneficial purposes of the interactions between health care professionals and industry that benefit patients and patient care. As the advocate for pediatric nurse practitioners, NAPNAP has developed this guidance for its members to enable them to better avoid accusations of impropriety, while still enhance or supplement patient care through beneficial and appropriate interactions with industry. The recommendations that follow are not legal advice and do not state the legal standards or requirements. Rather, these recommendations are intended to help NAPNAP members understand how to avoid scrutiny by steering clear of certain situations.

II. General Guidance

Pediatric nurse practitioners must be sensitive to assure appropriate interactions between themselves and the promotional and sales efforts associated with the pharmaceutical and medical device manufacturing industries. In order to avoid allegations of illegality or impropriety, NAPNAP recommends that its members follow these basic principles with industry:

. NAPNAP members should use their judgment as ethical health care professionals and err on the side of caution; if something feels uncomfortable, they should trust that instinct.

. Compensation, in cash or in kind, provided by industry should only be in return for actual work or time provided by the health care professional and must be commensurate with the value of the work or time provided.

. The receipt of any compensation, in cash or in kind, or other promotional benefits should never be linked with any promise of future prescribing activity, future purchases or other types of support for products.

. Lavish gifts or entertainment, should not be accepted.

. PNPs should use caution when charging patients for items or goods that the professional receives at a discount, and should avoid charging patients for goods or items received for free.

III. Recommended Questions NAPNAP Members Should Ask Themselves When Interacting With Industry

NAPNAP recommends that, whenever a PNP is approached by an industry representative, the health care professional should ask himself or herself the following initial questions. If the answer to any of these questions is yes, then the activity likely could be characterized as a conflict, inappropriate, or even as a legal or regulatory risk. In such instances, NAPNAP recommends that its members exercise extreme caution.

. Are you being offered a gift of more than token value by the company? (Any gifts accepted by PNPs should primarily be for patients' benefit, not the PNP's benefit. This would include items of token value such as pens or notepads. Gifts of textbooks, stethoscopes are appropriate if they serve a genuine educational function.)

. Did the presentation or pitch address the fact that you have historically been a high prescriber of that company's products? That is, has it been made obvious to you that the reason you have been selected as the recipient of a "perk" is the fact that you have been a high prescriber of the company's products?

. Is the company proposing to provide some type of financial benefit to you, if you agree to switch from a competing product to that company's product?

. Do you feel an obligation to respond (for example, by prescribing the company's products) when offered a financial benefit from a company? That is, is the offer likely to affect your prescribing habits?

. Are you being asked to participate in a "research grant" program in which you are given payments for minimal or nonexistent record keeping tasks? Are you being offered restricted research or education grant funds? Are you being offered compensation to participate in a study which has no apparent benefit to the company or the patient community?

. Are you being offered grants for studies of drugs or devices when the studies are of questionable scientific value and require little or no actual scientific pursuit?

IV. Specific Operational Suggestions

In addition to the recommendations articulated above, NAPNAP refers its members to the PhRMA Code on Interactions with Healthcare Professionals for additional information. The following operational recommendations are based, in part, on the PhRMA guidelines, and are provided to NAPNAP members as practical considerations.

Receipt of Gifts and Entertainment: General Recommendations

Gifts received by a health care professional in a position to make or influence purchasing decisions from industry should be related primarily to the health care professional's work and/or produce a benefit to patients. Gifts should be items of no more than modest value, and should be limited to items that primarily benefit patients, and are not primarily a benefit to a PNP's practice or business.

PNPs should use their judgment concerning an estimated value for a gift or entertainment in the "open market." Regardless, even gifts of no more than modest value should not be accepted frequently nor be received by large numbers of individuals in the same practice or organization.

Examples:

Examples of appropriate gifts from industry that are not likely to cause a conflict of interest or kickback include:

. Pens, notepads, or magnets.

. Modest lunches or dinners if accompanied with an educational presentation or discussion.

. Diagnostic equipment, or medical or scientific textbooks, of no more than modest value.

Not Recommended:

NAPNAP members should use extreme caution when being offered the following

from industry:

. Cash or cash equivalents. These should never be accepted in the absence of actual services. This includes such items as gift certificates, coupons exchangeable for a gift of the recipient's choice, airline frequent flyer points, or vouchers covering the cost of uncompensated care.

. "Points" based rewards or gifts.

Faculty or Consultant Arrangements/Focus Groups:

Individuals who are bona fide meeting faculty, company consultants, researchers,

or individuals who participate in industry focus groups may receive reasonable

compensation for services rendered. In addition, NAPNAP advises its members to

provide these services in accordance with an appropriate written contract.

. Compensation for personal services may include reasonable travel costs and either an honorarium or payment for the faculty member's time. Payment for time should reflect fair-market value.

. PNPs serving as faculty or company consultants should provide only legitimate, commercially reasonable services with real value, and he or she should perform the described services personally.

. PNPs should decline token consulting or advisory arrangements. If a NAPNAP

member believes that the benefits received exceed the value of the contribution made, the member should consider a reevaluation of the relationship.

Attendance at Continuing Medical Education and Similar Activities

Underwritten Costs of Continuing Education Activities

Pharmaceutical or other companies frequently will underwrite the costs of continuing education activities such as grand rounds, continuing educational conferences or provider specialty association meetings. NAPNAP recommends that its members consider the following principles regarding attendance at such events or activities:

. Nurse practitioners attending the activity or event should not accept educational grants or other funds or benefits merely for attending the activity or event, or to cover the cost of attending the activity or event.

. Educational grants may be used to reduce or eliminate the registration fee for a conference or continuing medical education course for all attendees, but not on an individual or per-case basis. PNPs should not accept checks or vouchers to offset the registration fee at a particular conference or at a conference of the recipient's choosing.

Educational Dinners

Pharmaceutical or other companies may sponsor special educational dinners or other similar programs. The meal or other social activity should not be extravagant. Even for programs that do not carry continuing education credit, the educational component of the program should be of legitimate educational value. Otherwise, the program should be considered to be a gift or pure entertainment.

Faculty or Organizer

PNPs who present or organize continuing education programs or similar events should at all times retain responsibility and control over the content or choice of faculty of the conference, meeting, or lecture.

In order to assure that all educational activities have balance, independence, and objectivity all faculty participating in sponsored programs should disclose to the program audiences any associated or apparent conflicts(s) of interest related to the content of their presentations).

Students

PNP students may receive sponsorship funds to attend the educational, scientific, or policy-making meetings of national, regional and specialty professional associations. Payments, however, may not be made directly to any individual and the institution or professional association must select the attendee(s).

Promotional Events

PNPs should not accept cash or cash equivalents to attend promotional events such as product launches or presentations about new label indications. NAPNAP recommends that in such situations pediatric nurse practitioners accept only a modest gift and/or a modest meal.

Attendance at Social Events

Attendance by PNPs at industry sponsored social events such as a sporting event or a theatrical performance generally should be avoided unless the event is compensation for bona fide services provided by the PNP to the sponsoring company. Moreover, PNPs should be wary of the potential impropriety of the aggregation of several such events. Spouses, relatives, or friends of the PNP who attend any event must pay their own expenses, including the price of any ticket or the cost of their meals.

Drug Samples and Free Drug Product

Patients should never be billed or charged, directly or indirectly, for the provision or use of products labeled as "Samples -Not for Resale or Distribution."

Free and Discounted Drugs

As for free or discounted products that are not samples, PNPs should not, directly or indirectly, bill patients or receive any remuneration for the provision or use of products that the health care professional or his or her practice receives for free (and not part of a contractual based volume discount). In many circumstances, however, volume discounts are appropriate.

NAPNAP advises all of its members to be wary of companies that attempt to sell their products by marketing the profitability potential or spread of their products.

In addition, NAPNAP recommends that to avoid impropriety, PNPs should not accept samples of products for their own personal use or use by their families.

Promotional Items for Patients

PNPs sometimes receive from industry various products or items that directly benefit patients, such as "new baby packs." NAPNAP members should be aware of potential issues which may arise.

· PNPs should never accept such packages or similar items in return for ordering or recommending items or services such as prescription drugs or other health care supplies. Such conduct risks violating federal and/or state anti-kickback statutes, as well as ethical standards. The sale of such items to patients creates further kickback and ethical problems.

The receipt of gifts, entertainment or other promotional benefits should never be linked with any promise of future prescribing activity, future purchases or other types of support for products.

This guidance is intended to establish general advice and recommendations for NAPNAP members regarding their interactions with pharmaceutical medical device and medical drug companies and should not be considered to articulate specific legal standards. Further. the recommendations are neither definitive nor binding. Questions about specific activities or arrangements should be directed to a competent health care attorney.

Resources

For additional guidance, NAPNAP refers its members to:

· PhRMA Code on Interactions with Healthcare Professionals.

http: www. phrma.org/mediaroompressreleases/9.04.2002.390.cfm

· The Federal Anti-Kickback Statute at 42 U.S.c. 1320a-7b(b), and the

corresponding safe harbor regulations at 42 C.F.R. 1001.952.