Relationships between physicians and medical device manufacturers are essential to the development of new technologies and innovative treatments.
However, a recent article from the American Academy of Orthopaedic Surgeons (AAOS) noted that physician-industry relationships have potential implications for fraud and abuse with programs in the Centers for Medicare and Medicaid Services (CMS). The article noted that, “when engaging in relationships with manufacturers, physicians must be careful to avoid any arrangements that could be interpreted as violating antikickback or self-referral statutes.
The AAOS, AdvaMed (the association of medical device makers), and PhRMA (the association of drug manufacturers) have all established ethical codes to guide interactions between companies and healthcare professionals. These codes prohibit companies from using financial agreements and other gratuitous arrangements to encourage physicians to use their products.
AAOS noted that, “surgeons who are presented with the opportunity to work as paid consultants or promotional speakers should evaluate whether the compensation being offered for the service(s) is fair and at market value. An inflated figure could be seen as an attempt to induce physician loyalty and promote bias in the presentation.”
AAOS further explained that, “all consulting arrangements should be in writing and describe all services to be provided. Agreements covering clinical research services should include a written research protocol. Additionally, consulting arrangements should be based on a legitimate need for the services and consultants should be chosen on the basis of their qualifications and expertise.”
In addition, the article noted that, “arrangements with device companies that influence a physician’s decision to use a specific device based solely on financial incentives violate antikickback statutes.” Such violates could lead to physicians incurring significant penalties, losing licensure, and even facing jail time. Other arrangements that might be seen as violating antikickback statutes include
– Preferred lease agreements with a hospital where the physician practices;
– Research support;
– Gifts, travel, or entertainment unrelated to the provision of services; and
– Food or meals provided by an industry representative for the physician and office staff.
The article also explained that orthopaedic surgeons who initiate innovations or inventions, which may result in the payment of royalties by a manufacturer, should disclose their role in the device’s development to patients—as well as their receipt of royalties for its use to avoid the inference of impropriety. It is important for patients to know that the use of a medical device is in the patient’s best interest and not tied to a surgeons financial interests.
Transparency and gift reporting
The AdvaMed Code of Ethics on Interactions with Health Care Professionals states that companies “may not give health care professionals any type of non-educational branded promotional items, even if the item is of minimal value and related to the health care professional’s work or for the benefit of patients.”
The article noted that under the Patient Protection and Affordable Care Act (PPACA), the Physician Payment Sunshine Act will require drug, device, and biologic companies to track all payments and transfers of value to U.S. healthcare providers made on or after Jan. 1, 2012. The law also requires companies to report any payment or transfer of value with a minimum value of $10/payment or $100/year (cumulative) to HHS and to publicly disclose the information on their websites, beginning in 2013.
AAOS also pointed out how some academic institutions have also chosen to regulate interactions between faculty members (or affiliated physicians) and industry. Accordingly, the article recommend that, “physicians who are affiliated with such institutions should reference their institution’s policies before engaging in industry-sponsored research, applying for industry-sponsored educational or research grants, or serving as a consultant or director for a device company.”
The article also recommended that physicians should carefully note the distinctions between promotional sessions, which generally focus solely on a particular device brand, and education sessions such as continuing medical education (CME), which take a broader approach, assessing all available treatment options and devices for a specific condition. “Physicians should also pay attention to the conflict of interest disclosures made by the presenters, as well as the degree of bias in the presentations.”
A compliance program
Finally, the article noted that under PPACA, physicians who treat Medicare and Medicaid beneficiaries must establish compliance programs. Although the law does not specify when this mandate will be implemented, AAOS recommended initiating a program now. According to the Office of the Inspector General (OIG), an adequate compliance program should include the following components:
- Internal monitoring and auditing
- Written compliance and practice standards
- A compliance officer or contact
- Appropriate training and education
- Appropriate response to offenses and timely corrective action
- Open lines of communication
- Enforcement of clear, well-publicized disciplinary standards