American Society of
Interventional Pain Physicians
Recommendations for
Minimizing Legal Risk in Relationships between Health Professionals and
Industry
(Revised June 2004)
This guidance is intended to offer general
advice and recommendations to ASIPP members regarding their interactions with
pharmaceutical and medical device companies, and should not be considered
legal advice. Further, these
recommendations are neither definitive nor binding. Members with questions about specific activities or arrangements
should seek the advice of legal counsel.
I. Summary
Over the last several years, the federal government has begun to pay closer attention to relationships between the pharmaceutical, medical device and durable medical equipment industries and the provider community. Through enforcement activity, regulation and other official guidance, the government has made clear that certain financial relationships between providers, manufacturers and suppliers constitute an improper inducement for referrals and can be prosecuted under health care fraud and abuse laws. Potentially suspect relationships may arise out of seemingly ordinary physician activities such as participating in industry funded research, providing consulting services, meeting with industry sales personnel or attending educational seminars. While these and other similar relationships between providers and industry often serve a socially beneficial purpose, inappropriately structuring the arrangement may result in unnecessary government inquiries. Moreover, even the appearance of a conflict of interest can undermine patients’ trust and confidence in their interventional pain care professionals.
The members of the American Society of Interventional Pain Physicians (“ASIPP”) are leaders in their field, performing state of the art interventional pain procedures. Because of the size of their practices as well as their reputation in their profession, ASIPP members are highly desirable customers from the perspective of industry, and high profile targets for both competitors and aggressive enforcement authorities. Accordingly, many ASIPP members have asked for recommendations on how to appropriately interact with industry and avoid accusations of impropriety. ASIPP agrees that its members should give serious thought to their own interactions with industry. Members are advised to educate themselves about the risks associated with industry relationships in order to protect themselves and their practices.
ASIPP remains mindful that interactions between professionals and industry frequently, directly or indirectly, benefit patients and patient care. As the patient’s quality interventional pain advocate, ASIPP has developed guidance for its members in order to enable them to avoid accusations of impropriety, while at the same time continue advancing patient care through beneficial and appropriate interactions with industry. The recommendations that follow do not explain any specific legal standards or requirements, but rather are intended to help ASIPP members understand how best to recognize and avoid potentially troublesome relationships with industry.
II. General Guidance
As a general matter, members are advised to use careful judgment and a little common sense in evaluating arrangements with industry; to err on the side of caution; and to trust their instincts. In other words, if a proposed arrangement feels uncomfortable or too good to be true, then it probably should be avoided. More specifically, ASIPP recommends that its members follow these basic principles:
· Compensation, in cash or in kind, provided by industry should only be in return for actual work or time provided by the 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 either to continue using, purchasing or prescribing a manufacturer’s product or to do so in the future.
· Gifts of any kind that have more than a nominal value should not be accepted.
· Professionals 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; provided that physicians should never bill any patient or insurer for free drug samples provided to patients.
III. Recommended Questions ASIPP Members
Should Ask Themselves When Interacting With Industry
ASIPP recommends that whenever a professional is approached by an industry representative, the professional should ask himself or herself the following initial questions:
§
Are you being
offered a gift of more than token value by the company?
§
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?
§
Is the
arrangement likely to influence your prescribing habits? In other words, has the company offered you
anything of value that could be viewed as affecting your professional judgment?
§
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 unreasonably large or unrestricted 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?
§ Does the arrangement or practice have a potential to increase the risk of overutilization or inappropriate utilization? Is there a risk of unnecessarily increasing health care costs?
If the answer to any of these questions is “yes,” then the activity could be characterized as a conflict of interest or even an improper inducement to the member. In such instances, the arrangement may present legal risks to the professional and, therefore, ASIPP recommends that its members exercise extreme caution.
IV. Specific Operational Suggestions
As the government agency primarily responsible for investigating allegations of federal health care fraud and abuse laws, the Office of Inspector General for the Department of Health and Human Services (“OIG”) has become increasingly concerned about the affect relationships between professionals and industry have had on the integrity of healthcare in the United States. In an effort to encourage industry and providers alike to pay attention to this issue, the OIG issued guidance for minimizing risk in relationships with pharmaceutical companies. Similarly, the American Medical Association (“AMA”), the Pharmaceutical Research and Manufacturers of America (“PhRMA”) and the Advanced Medical Technology Association (“AdvaMed”) have also published compliance guidance for their members. On behalf of its members, ASIPP has considered the recommendations offered by each of these entities and has developed the following operational recommendations for ASIPP members.
Gifts and Entertainment
General Recommendations
Gifts received by a professional in a position to make or influence purchasing decisions from industry should be related primarily to the professional’s work and/or produce a benefit to patients. Gifts should be items of no more than modest value. Members should use their judgment concerning an estimated value for a gift or entertainment expense 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 include:
· Token gifts provided for marketing purposes such as pens, notepads, coffee mugs.
· Modest meals, as long as a company representative attends and relevant business is discussed. ASIPP cautions against permitting the company to pay for guests of the professional that have no legitimate professional interest in attending.
· Diagnostic equipment (e.g. anatomical models, stethoscopes), or medical or scientific textbooks, of no more than modest value (typically, $100 or less).
Not
Recommended
In most instances, ASIPP members should decline the following gifts from industry:
· Cash or cash equivalents in the absence of the professional’s performance 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.
· Lavish gifts or entertainment (e.g., palm pilots, World Series tickets)
Consultant Arrangements/Focus Groups
Individuals who are bona fide company consultants, researchers, or individuals who participate in industry focus groups may receive reasonable compensation for services rendered. In addition, ASIPP 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.
· Professionals serving as faculty or company consultants should provide only legitimate, commercially reasonable services with real value, and should perform the described services personally.
· Professionals should decline token consulting or advisory arrangements. If an ASIPP member believes that the benefits received exceed the value of the contribution made, the member should consider reevaluating the relationship.
Continuing Medical Education and Similar Activities
Costs of Continuing Education
Activities
Pharmaceutical, medical device or other companies frequently will underwrite the costs of continuing education activities such as grand rounds, continuing educational conferences, or medical specialty association meetings. ASIPP recommends that its members consider the following principles regarding attendance at such events or activities:
· Professionals 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. Professionals 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, medical device 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 medical education credit, the educational component of the program should be of legitimate value to the professional. Otherwise, the program should be considered to be a gift or pure entertainment. For instance, members should not accept advance payment, vouchers or reimbursement for meals or entertainment not attended by a company representative.
Faculty
or Organizer
Professionals who present or organize CME or similar events should at all times retain responsibility and control over the content or choice of faculty of the conference, meeting, or lecture. Participants in these events may receive reasonable compensation for their efforts as long as such fees are commensurate with the value of their work and time.
Medical Students or Residents
Medical students, residents, or fellows may receive sponsorship funds to attend the educational, scientific, or policy-making meetings of national, regional and specialty professional associations. However, payments may not be made directly to any individual and the institution or professional association must select the attendee(s).
Promotional
Events
Professionals should not accept cash or cash equivalents to attend promotional events such as product launches or presentations about new label indications. ASIPP recommends that in such situations professionals accept only token gifts and/or modest meals.
Free
Samples and Product or Device Demos
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.”
ASIPP recommends that professionals not accept samples of products for their own personal use or use by their families. In contrast, the AMA guidelines permit the receipt and use of samples for personal or family use, so long as such practices to do not interfere with patient access to samples. ASIPP, however, urges its members to use caution and avoid even the appearance of a conflict in this regard.
With respect to free or discounted products that are not samples, professionals should not, directly or indirectly, bill patients or receive any remuneration for the provision or use of products that the professional or his or her practice receives for free. The professional may be able to bill for items received at a reduced charge or free of charge if the items were part of an appropriate volume-based discount from the manufacturer. However, ASIPP members should be sure that the discount arrangement is in fact permissible. For instance, it may be illegal to bill for discounted products if the products are reimbursed under the Medicare fee schedule or the same DRG.
V. Conclusion
Although compliance with ASIPP’s or other industry guidance has no binding legal authority and cannot guarantee protection from potential legal consequences, it can substantially reduce the risk of fraud and abuse and help demonstrate a good faith effort to comply with the law. More importantly, ASIPP believes that by understanding the issues, members will be better equipped to ask the right questions and identify potential risk areas in their interactions with industry. ASIPP’s members have worked hard to earn their reputations as caring and highly skilled interventional pain physicians. It is for this reason that ASIPP recommends that its members be cautious in their relationships with industry and, above all, avoid any situation that could be construed as compromising your independent professional judgment.
* * *
Prepared By: Allison W. Shuren, Esq., Arent Fox PLLC, 1050 Connecticut Avenue, NW, Washington, D.C. 20036
E-mail: shuren.allison@arentfox.com
For additional guidance, ASIPP refers its members to
· OIG Compliance Program Guidance for Pharmaceutical Manufacturers, 68 Fed. Reg. 23731 (May 5, 2003).