February 7, 2003
Department of Health and Human Services
330 Independence Avenue, S.W.
Washington, DC 20201
Re: OIG-71-N - Solicitation of New Safe Harbors and Special Fraud Alerts
Dear Ms. Rehnquist:
In response to the Office of Inspector General's (OIG) December 9, 2002 solicitation of new anti-kickback safe harbors, the American Urological Association (AUA) is pleased to comment on your request for new safe harbors and also the granting of hospital staff privileges.
I. Request for a new safe harbor
The AUA requests that the OIG develop a safe harbor for continuing medical education (CME) and non-CME programs that are sponsored by medical societies, financed by pharmaceutical manufacturers and meet certain requirements as discussed below.
In its October 3, 2002 Draft Compliance Program Guidance for Pharmaceutical Manufacturers, the OIG identifies financing of third-party educational meetings or conferences by pharmaceutical manufacturers to be a potential implication of the anti-kickback statute. We do not agree that such financing necessarily implicates the Anti-Kickback Statute. The mere fact that a pharmaceutical company provides financial support for a third-party educational conference which includes attendees who are physicians who may be in a position to prescribe the pharmaceutical company's products does not automatically mean that the Anti-Kickback Statute has been violated. As a threshold matter, there must be some linkage between payments and referrals in order for the federal statute to come into play.
There is no such link, however, when, as is the case with the AUA's meetings, the financial support is not provided directly to the physician attendees, but is provided directly to the conference's sponsor (i.e., AUA), which, in turn, uses this support to subsidize the conference registration fee for all attendees, including any non-physician attendees, as well as physicians who may not be in a position to order products manufactured by the pharmaceutical sponsors. Also, the content of the educational meetings is determined by the AUA, not the pharmaceutical sponsors. Since sponsors do not determine which AUA members participate in AUA programs and enrollment is not based on the "volume or value" of any pharmaceutical purchases, we fail to see any linkage that could implicate the statute in any meaningful manner.
Because of this, we requested that the OIG omit the relevant statement from the final guidance or add the following language:
The OIG is not intending by this comment to discourage third-party sponsorship where a medical specialty association offers a broad array of scientific, clinical and practice-related educational programs and the physicians who choose to attend do so voluntarily without regard to whether they use sponsor products or to the volume or value of the products that they could potentially use from the sponsor.
We explained our great concern that, in the absence of this kind of clarifying statement, the OIG guidance will have a fundamentally negative effect and will be viewed by the physician community as the product of a lack of clear understanding of the medical profession, the specialty associations that are dedicated to the highest standards of patients under their care and the education offered in order to fulfill that mission.
Also in our comments on the draft guidance, because this issue is so vital for physicians in our country, we said it would be helpful for the OIG to engage in some type of process to give separate guidance on this issue. Exploring the possibility of developing a safe harbor is an appropriate process to use in conjunction with the OIG's work on the final guidance document, as a safe harbor is certainly one way to resolve this issue. However, we are concerned that a safe harbor may not be available within a reasonable time frame and continue to stress that eliminating the language indicated above would be the best solution without disrupting the important educational activities of medical specialties.
Continuing medical education (CME) courses sponsored by medical societies are governed by the requirements of the Accreditation Council for Continuing Medical Education (ACCME). The ACCME's "Essential Areas, Elements, and Decision-Making Criteria" and "Standards for Commercial Support of Continuing Medical Education" ensure that the financial support provided by industry does not compromise the integrity of educational programming or unduly influence physician attendees. The ACCME's Standards for Commercial Support address several areas that the OIG identified in its draft guidance, including independence of providers, faculty payments and expenses of non-faculty attendees. Thus, most of the groundwork is already completed for the OIG to fit CME offered by ACCME-accredited medical societies, such as the AUA, into a safe harbor.
Also, non-CME courses sponsored by medical societies and financed by pharmaceutical manufacturers are governed by the Pharmaceutical Research and Manufacturers of America's Guidelines, "Code on Interaction with Healthcare Professionals." And, as we discussed above, there is no link to establish an anti-kickback violation, especially as related to the factors listed in the December 9 proposed rule, such as access to health care services, the quality of care services, patient freedom of choice among health care providers, competition among health care providers, the cost to federal health care providers, the potential overutilization of health care services and the ability of health care facilities to provide services in medically underserved areas or to medically underserved populations.
Also, there is no potential financial benefit to health care professionals or providers that may vary based on their decisions to order a health care item or service or arrange for a referral for health care items or services to a particular practitioner or provider. Though some educational programs do not meet the ACCME's formal definition of CME, they provide important information to physicians in many different area such as practice management, medical coding and compliance. Thus, these programs, if they receive industry financial support and comply with the conflict of interest components of the ACCME's Standards for Commercial Support, should also be protected by a safe harbor.
II. Granting of hospital staff privileges for physicians
The AUA supports policy of the American Medical Association (AMA) that opposes the use of economic criteria unrelated to quality to determine an individual physician's qualifications for the granting or renewal of medical staff membership or privileges (AMA policy H-230.976). Policies or credentialing practices that exclude physicians based on the number of patient referrals are anti-competitive and should be closely evaluated by the OIG to determine whether they violate the anti-kickback statute. When a hospital bases clinical privileges on whether the physician will refer all patients to that hospital, clinical privileges become remuneration, which the OIG has defined to include "anything of value." When this happens, the privileges offered to the physician by the hospital can be seen as an inducement for patient referrals.
Hospitals compete with other hospitals as well as other entities including ambulatory surgical centers (ASC) and physician practices that do surgery in their office. It is best to determine the place of medical treatment based on the type of procedure being done and the clinical needs of each individual patient. It is often more convenient and less costly for patients if their clinical status allows their care to be provided in an ambulatory setting such as an ASC or physician office. If a hospital denies clinical privileges because it feels the physician will refer patients to a competitor, whether it be another hospital or any other entity, this limits patient choice and access to care and also undermines physicians' professional judgment. Decisions about where a patient receives care should be based on quality, not on competition considerations.
Thank you for considering our safe-harbor request and our comments on hospital credentialing of physicians for hospital staff privileges. If you have any questions or need additional information, contact Robin Hudson, Manager of Regulatory Affairs, at 410-689-3762.
Winston K. Mebust, MD
American Urological Association