ADVERTISING, DISTRIBUTION, & SALES
Medical device manufacturers must walk an increasingly narrow line between the aggressive marketing necessary to successfully launch a product in today's competitive environment and avoiding violations of the federal antikickback statute. As prescription drug and medical device utilization has increased in recent years, the cost of these items to federal healthcare programs has skyrocketed and has led to intense governmental scrutiny of manufacturers' marketing practices.
Although the pharmaceutical industry has garnered most of the headlines, medical device companies are also a target of inquiries, as demonstrated by recent Department of Justice investigations of orthopedic product and heart device marketing efforts. Failure to understand the interaction of a company's marketing efforts and the antikickback statute can be costly to a manufacturer in terms of negative publicity, the costs of responding to a government investigationeven investigations that do not result in sanctionsand potential penalties.
The Federal Antikickback Statute
The antikickback statute is a criminal prohibition against direct and indirect payments made for the purpose of inducing or rewarding the referral or generation of federal healthcare business.1 The statute extends equally to the solicitation or acceptance of remuneration for referrals. In addition to criminal penalties, violators may be subject to civil monetary sanctions and exclusion from federal healthcare programs.
Although liability under the antikickback statute ultimately hinges on a party's intent, it is possible to identify practices that may present significant potential for abuse. In order to do this, a manufacturer should examine remunerative relationships between itself or its representatives and persons or entities in a position to generate federal healthcare business for the manufacturer. Such relationships can include those with benefit managers, physicians, and pharmacists. Any single component of an arrangement that induces or rewards referrals or recommendations of federal healthcare business is enough to violate the antikickback law. In evaluating whether an arrangement involves a prohibited inducement, it is useful to consider whether the arrangement has the potential to interfere with or skew clinical decision making, increase costs to federal healthcare programs or beneficiaries, increase the risk of inappropriate utilization or overutilization, or raise patient-safety or quality-of-care concerns.
In 2003, the U.S. Department of Health and Human Services Office of Inspector General (OIG) issued "Compliance Program Guidance for Pharmaceutical Manufacturers" to encourage pharmaceutical companies to take certain measures to reduce fraud and abuse in federally funded healthcare programs.2 The compliance guidance identified a number of industry practices that could result in kickbacks and other illegal remuneration under the federal antikickback statute, and OIG indicated that this guidance may also have applications for medical device manufacturers.
Likewise, device industry association AdvaMed (Washington, DC) in 2003 published The Code of Ethics for Interactions with Health Care Professionals.3 These two documents provide useful direction for device manufacturers in managing risks under the antikickback statute that arise from practices such as discounting, incentive arrangements for independent sales agents, and various promotional activities aimed at physicians or those in a position to influence decisions and referrals.
Risks associated with marketing initiatives generally arise in connection with manufacturers' relationships with three groups: purchasers and their agents, including pharmacies, physicians, and health plans; sales agents; and persons or entities in a position to make or influence referrals, such as physicians. Based on historical law enforcement, this article identifies conduct that has the potential for abuse under the antikickback statute (see Figures 1 and 2). These same risks arise when manufacturers subcontract with outside firms to handle their marketing. Although there are certain steps manufacturers can take to minimize marketing-related risks, companies should place an emphasis on continually training every person involved in the firm's marketingboth employees and personnel at subcontracted firmsregarding the organization's standards for acceptable marketing practices.
Relationships with Purchasers and Their Agents
Among medical device manufacturers, offering an incentive to convince purchasers to buy a particular product has been a long-standing method for increasing sales. Although incentives are integral to competition, OIG recommends that manufacturers review all incentives closely to monitor for potential abuse.
In particular, discounting arrangements are a widespread marketing practice. Manufacturers frequently offer purchasersincluding direct buyers such as hospitals and pharmacies, as well as indirect buyers such as health plans--a variety of price concessions, which is considered remuneration. Any price concession that is related to a sale must be carefully structured. In addition to simple reductions in the price paid by a buyer, either in the form of a discount or rebate, manufacturers are constantly testing different types of discount arrangements. For example, a manufacturer might offer a coupon for a free glucose meter when the customer purchases a package of test strips to be used with that meter.
Current public policy favors price competition in healthcare, and discounts create price competition. Therefore, the antikickback statute provides a safe harbor for discounts that are offered to customers that submit claims to a federal healthcare programso long as those discounts are properly disclosed and accurately reported. The rules to qualify for the discount safe harbor are complicated, but the guiding principle is that discounts should be transparent to all parties involved in the transaction, including the healthcare program that ultimately pays for the device. In general, manufacturers that offer discounts should do the following.
Relationships with Independent Sales Agents
When a manufacturer employs a sales agent, the relationship is usually protected by a safe harbor. However, OIG has expressed long-standing concern about relationships with independent sales agentssuch as representatives from large distributors of medical devices and pharmaceuticalsdue to the tendency for those agents to be less accountable to a manufacturer than its direct employees.
The nature of a sales agent's job is to sell, and manufacturers want to encourage sales agents to sell their products. Manufacturer incentives to encourage more sales may include prizes, cash bonuses for increased sales volume, or a commission based on a percentage of sales of consumables to a particular provider. The risk of such incentives is that they can be considered remuneration in exchange for referrals. Recognizing the widespread use of incentives for sales agents, OIG has provided guidance to manufacturers regarding practices that should be avoided or minimized when dealing with independent sales agents because they could signal an intent to induce referrals.4
These practices are generally acceptable for employed sales agents due to the safeguards of the employment relationship and the protection of the personal services safe harbor. However, OIG states that the same practices present increased potential for program abuseparticularly overutilization and excessive program costswhen independent sales agents are involved. Practices that OIG has identified as heightening its concern about compensation paid to independent sales agents include the following.
Relationships with Physicians and Pharmacists
Payments to providers who are in a position to order devices present potential for abuse; and suspect manufacturer practices, such as providing lavish trips for physicians and their spouses, have been well publicized. Other potentially abusive practices are illustrated in the recent corporate-integrity agreement between the United States and Bayer Corp., under which Bayer is required to pay for independent review of all payments it makes to physicians for activities such as speaking agreements, consulting arrangements, and educational grants.5
Consulting and Advisory Payments. Manufacturers commonly pay physicians to serve as consultants by attending meetings, sitting on advisory boards, participating in focus groups, or accessing Web sites to view marketing information about a product or device. Without doubt, healthcare professionals are often best qualified to perform these services. However, arrangements in which physicians are paid to attend a meeting in a passive capacity are suspect because such events are often little more than a vehicle for the manufacturer to promote its product.
Another practice that threatens to violate the antikickback statute is referred to as detailing. In these arrangements, manufacturers pay physicians for time they spend accessing Web sites to view or listen to marketing information. Such materials are often characterized as "educational." In light of the government's concerns about these abuses, manufacturers should ensure that physicians are providing bona fide consulting services and are being paid fair market value pursuant to a written agreement for those services.
Educational Grants. Medical device manufacturers have long provided funding for educational activities. Such activities include financing conferences and endorsing monographs on diseases related to a manufacturer's products. Although such funding can be valuable, it also presents a perfect opportunity for improper inducements. Educational funding crosses the line of the antikickback statute when funding is contingent on the purchase of a product or is awarded to entities or individuals in a position to influence Medicare and Medicaid purchasing decisions. Likewise, if the manufacturer has influence over the content of a program or presentation, there is an additional risk that the educational event is a vehicle for inappropriate marketing.
In order to minimize risks inherent in educational grants, manufacturers should ensure that the activities and materials funded by grant money are bona fide educational activities. They cannot maintain control over the speaker or the content of a presentation, and the manufacturer's marketing department is not permitted to control the awarding of grants.
Marketing is integral to healthy competition, but many practices that are common in other industriesand have long been accepted in the healthcare industrynow present unacceptable risks for medical device manufacturers. Companies may continue to pursue creative marketing initiatives, so long as everyone involved understands governmental concerns regarding improper inducements. To avoid abuses and their potentially expensive consequences, manufacturers should implement strict controls over marketing practicesand monitor them continually.
1. Federal Healthcare Antikickback Act, U.S. Code, vol. 42, sec. 1320 (2000).
2. "OIG Compliance Program Guidance for Pharmaceutical Manufacturers," Federal Register, 68 FR:23731- 23734 (May 5, 2003).
3. Code of Ethics for Interactions with Health Care Professionals (Washington, DC: AdvaMed, 2003); available from Internet: www.advamed.org/publicdocs/code_of_ethics.pdf.
4. "OIG Advisory Opinion 98-10" (August 31, 1998); available from Internet: www.oig.hhs.gov/fraud/docs/advisoryopinions/1998/ao98_10.htm.
5. "Addendum to Corporate Integrity Agreement between the Office of Inspector General of the Department of Health and Human Services and Bayer Corporation" (2003); available from Internet: www.oig.hhs.gov/fraud/cia/agreements/BayerCorporation120301.pdf.