On April 28, 2003, the Office of the Inspector General (OIG) of the U.S. Department of Health and Human Services released its Compliance Program Guidance for Pharmaceutical Manufacturers (the Guidance), the latest in a recent series of OIG compliance guidances directed to a specific sector of the health care industry. The Guidance outlines steps to assist pharmaceutical manufacturers in promoting compliance with applicable health care laws and regulations, particularly the U.S. Anti-Kickback Statute, False Claims Act and Medicaid Drug Rebate Act (also known as the Medicaid Best Price Act). Generally, the Guidance reaffirms positions advanced by the OIG in an initial draft released in October of 2002 (Draft OIG Compliance Program Guidance for Pharmaceutical Manufacturers, 67 Fed. Reg. 62057 (October 3, 2002)). However, the final Guidance revises the OIG’s position on several issues, including consulting arrangements with physicians and educational and research grants.
The release of the Guidance reflects the OIG’s heightened scrutiny of financial relationships between drug manufacturers, drug purchasers and prescribers. Although the OIG states that the Guidance creates no new law and that compliance is voluntary, the Guidance calls into question certain common industry practices. Accordingly, drug manufacturers, purchasers and prescribers should evaluate their business relationships to assess compliance with the principles set forth in the Guidance and determine what, if any, changes may be advisable to current business practices.
Implementation of Compliance Program
Suspect Arrangements
Integrity of Data and Government Reimbursement
To avoid liability under the False Claims Act and federal Anti-Kickback Statute for AWP or AMP manipulation, the Guidance indicates that reported prices should reflect actual wholesale price transactions adjusted to account for all forms of purchasing concessions. These concessions may take the form of price reductions, discounts, rebates, up-front payments, free or discounted "bundled" goods or services, grants, coupons or other items of value.
As in the draft guidance, the final Guidance expresses concern regarding active marketing of the "spread" by pharmaceutical companies. The "spread" is the difference between the wholesale price of the manufacturer and the reimbursement rate recoverable by the purchaser. "Marketing the spread" refers to the practice of encouraging product purchases based on the potential profit that customers can realize from the spread in relation to similar margins on competing brand-name or generic drugs. AWP manipulation in conjunction with marketing the spread (i.e., acting to inflate profits to drug purchasers) would appear to be particularly suspect conduct in the view of the OIG. The Guidance describes it as evidence of "unlawful intent."
The Guidance also indicates that the federal Anti-Kickback Statute is potentially implicated when manufacturers manipulate the AWP to increase customer profits from federal drug reimbursement programs. The Guidance, however, does not clarify how to accurately calculate an AWP, an issue of debate within the industry. In addition, though the Guidance states that "marketing considerations" should not "inappropriately" influence AWP reporting by manufacturers, it is not clear what "inappropriately" means in this context. Manufacturers by definition must consider marketing and profitability in the course of setting prices. On the other hand, inaccurate reporting of wholesale price sales for purposes of manipulating AWP is clearly improper in the view of the OIG. What is not entirely clear is whether the OIG views marketing the spread alone, in the absence of AWP manipulation by the manufacturer, as potentially involving the offering of illegal "remuneration" under the Anti-Kickback statute.
Kickbacks to Purchasers Providers and Agents
- Does the arrangement or practice have potential to interfere with or skew clinical decision-making? Is all provided information fully accurate?
- Does the arrangement or practice have the potential to increase costs to the federal healthcare program? Does the arrangement have the potential to be a disguised discount to circumvent the Medicaid Rebate Program Best Price calculation?
- Does the arrangement or practice have the potential to increase the risk of overutilization?
- Does the arrangement or practice raise patient safety or quality of care concerns?
The Guidance specifically addresses Anti-Kickback risks in manufacturer relationships with purchasers, physicians and sales agents.
Relationships with Purchasers
The final Guidance expands on the draft guidance by including a detailed discussion of manufacturer grants to purchasers for research and education. The OIG advises manufacturers to use "Chinese walls" for marketing and grant making activities to demonstrate that grants are bona fide and not improperly influenced by marketing considerations. The OIG also recommends that research grants be structured within the personal services safe harbor to the Anti-Kickback Statute. This may be difficult to accomplish since many grants are not given in exchange for "fair market value" research consideration, and the precise schedule and intervals of research activities are not knowable in advance or conducive to being reduced to written agreements.
The final Guidance also expands on the draft guidance by addressing manufacturer relationships with health insurers and pharmacy benefit manufacturer companies (PBM) with respect to influencing formulary listings. The OIG acknowledges in the Guidance that formularies can promote the effective cost-management of drug benefits, so long as formulary selection is driven by considerations of clinical efficacy uncompromised by improper financial inducements. Practices that the OIG believes pose a significant potential for abuse include financial relationships with formulary committee members, lump-sum payments for formulary placement and the use of rebates outside of the safe harbors for group purchasing organizations or managed care arrangements.
Relationships with Providers
Because health care providers may refer, order or otherwise influence the volume of drugs prescribed, some common relationships between manufacturers and providers raise potential Anti-Kickback concerns for the OIG. The final Guidance voices the OIG’s concerns that payments to physicians engaged by manufacturers for consulting and advisory services may be disguised kickbacks to induce prescribing the manufacturer’s products. The Guidance cites hiring physicians to help ghostwrite marketing speeches, or funding manufacturer-sponsored preceptorships in which physicians learn by "shadowing" other providers, as examples of arrangements that the OIG may find questionable.
A new section of the Guidance discusses "drug detailing" practices, which are marketing practices designed to educate providers about the available scientific information relating to a specific drug. The OIG describes as "highly suspect" compensation given to providers in return for their attendance at "educational" presentations or for filling out minimal paperwork. The final Guidance also expresses concern that the Anti-Kickback Statute may be implicated by "switching" arrangements (referring to the practice of offering rebates to a physician for switching from a competing product to the manufacturer’s product).
The Guidance also identifies "indicia of questionable research" that may cover disguised kickbacks. The indicia include research contracts that come through the drug company’s marketing department; research that is not reviewed by the manufacturer’s science department; research that is "unnecessarily duplicative" or not needed for any purpose other than the generation of business; and post-marketing research used as a pretense for product promotion.
As noted above, the Guidance recommends that, whenever possible, manufacturer relationships with providers, including research relationships, be structured within the personal services safe harbor to the Anti-Kickback Statute. However, many common business relationships cannot fit squarely within this safe harbor. For these more complicated business relationships, the Guidance refers manufacturers to model guidelines published by the Pharmaceutical Research and Manufacturers of America (PhRMA). PhRMA is a trade association composed of research-based pharmaceutical and biotechnology companies. In April of 2002, PhRMA adopted its Code on Interactions with Health care Professionals (the Code) to provide its members with rules for ethical interactions with providers. Generally, the Code focuses on structuring relationships to preserve the provider’s independence of clinical decision-making. The Code advises manufacturers that "nothing should be offered or provided in a manner or on conditions that would interfere with the independence of a healthcare professional's prescribing practices."
The Guidance indicates that compliance with the Code can "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." This endorsement by the OIG suggests that manufacturers and providers would be well advised to follow the rules outlined in the Code.
Relationships with Sales Agents
Drug Sample Regulation
The Guidance raises questions regarding many common pharmaceutical industry arrangements with sales agents, purchasers, providers and prescribers. While recommending that arrangements be structured to meet Anti-Kickback Statute safe harbors, in some instances, the OIG suggests that it may not respect the impregnability of safe harbor protection. Although the OIG cites the PhRMA Code with favor, it offers little guidance or comfort for the many business arrangements in the pharmaceutical industry that fall outside the narrow scope of the Anti-Kickback safe harbors. Drug manufactures, drug purchasers and providers should review and reevaluate, as necessary, their current arrangements in light of the heightened government sensitivity to, and scrutiny of, financial relationships with pharmaceutical companies.
The content of this article does not constitute legal advice and should not be relied on in that way. Specific advice should be sought about your specific circumstances.