Marti L. McCulloch, BS, MBA, RDCS, FASE

Have you noticed a difference in your relationship with industry lately? Remember all of the social functions (dinner/happy hour) and educational vendor-sponsored events that no longer happen? Well, changes evidently began with the pharmaceutical companies and are now affecting medical equipment and device companies. Venders are no longer allowed to provide food or beverage at educational (local society) events, as this is viewed as trying to win favor with attendees. They can’t provide speakers at educational events, nor can they hand out “giveaways” like notepads, pens, keychains, or the like. They are restricted to handouts that provide educational content only.

The cause for change (right or wrong) essentially stems from perceived conflicts of interest that can occur between the medical profession and industry. And as with most consequences of change, there are always additional driving forces in the background manipulating the rules for engagement.

Over the last several years there has been significant focus on conflicts of interest within the medical profession. In fact, physician referral to facilities in which they have financial interest was one of the first conflicts of interest issues addressed by what is known today as the Stark Law. Stark I was initiated in Congress as a provision in the Omnibus Budget Reconciliation Act of 1989 (OBRA 1989) that went into effect in 1992, restricting self referrals for laboratory services provided to Medicare patients. Since then, Stark II (OBRA 1993) extended restrictions for other services (including cardiovascular ultrasound) that some believe may represent unwarranted intrusion into the practice of medicine.

Regardless of the intent of the Stark Law, conflicts of interest continue to get a great deal of attention due to the public perception of medical relations with industry, especially when there is a financial transaction. In fact, Massachusetts Health and Human Services recently published data from 2009 regarding industry payments (device and pharmaceutical) to physicians and health care professionals. The www.mass.gov web site has prepared reports regarding payment from manufacturers to physicians and acute care hospitals. The reports even include listings of the top paid hospitals and physicians, with a function to search for specific facilities or individuals. This is most likely in response to the new health reform law, the Patient Protection and Affordable Care Act (PPACA), that incorporates the proposed Physician Payment Sunshine Act introduced by Senators Grassley and Kohl in 2009 and passed in 2010. The Sunshine Act enforces transparency in disclosing information with respect to the date, amount, and nature (e.g., speakers’ bureau, consultant, advisory board) of the payment. The Act has planned recording (requires manufacturers to record financial transactions with physicians and others) in 2011 and planned reporting (financial transactions will be made public) for January 2012.

In addition to the government mandate for disclosure, multiple organizations/entities including the Joint Commission, IRS, NIH and Institute of Medicine (IOM) have crafted policies/criteria for identifying conflicts of interest that may be impacting the policy followed at your facility. One of the most influential, the Council of Medical Specialty Societies (CMSS), has produced a “Code for Interactions with Companies” ( www.cmss.org ). This code, which supports transparency, a move away from industry engagement in physician activities and guidelines on company giveaway items, was supported and signed by 30 major medical specialties, including the American College of Cardiology.

There are also several organizations guiding industry compliance for appropriate interaction of vendors with healthcare professionals. The outcome can be noted by differences in the rules that are applied depending on what “guidelines” the vendor is using. Below are a few of the compliance resources and associated web sites for more information:

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  Office of Inspector General (OIG) Compliance Program Guidance for Pharmaceutical Manufacturers – http://oig.hhs.gov/publications/docs/workplan/2010/Work_Plan_FY_2010.pdf

  
  
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  The Pharmaceutical Research and Manufacturers of America (PhRMA) Code on Interactions with Healthcare Professionals – http://www.phrma.org/about/principles-guidelines/code-interactions-healthcare-professionals

  
  
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  The International Federation of Pharmaceutical Manufacturers Association (IFPMA) code of Pharmaceutical Marketing Practices – http://www.ifpma.org/news/news_market.aspx

  
  
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  Advanced Medical Technology Association Code of Ethics on Interactions with Health Care Professional (AdvaMed Code) – http://www.neuromodulation.com/assets/documents/advamed-code-of-ethics_33.pdf

Okay, so we have government and organizational bodies dictating transparency for the healthcare professional as well as various codes of conduct for vendors. What really complicates the healthcare provider/vendor relationship are the rules associated with continuing medical education (CME). Traditionally, the key element tying healthcare professionals to vendors was the educational opportunities provided by the vendors. The rules for CME have changed dramatically since 2004, and many national and local societies are feeling a significant impact related to reduced funding for educational programs. The Accreditation Council for Continuing Medical Education (ACCME) has specific policies regarding commercial support and disclosure for all approved CME providers. The policy essentially states that CME activities must be free of commercial influence (vendor has no say in content) and speaker conflicts must be identified, resolved and disclosed to the learner. In addition to the ACCME policies, vendors have specific restrictions on what educational venues they are able to support, and depending on what compliance code the vendor adheres to, the rules may differ from vendor to vendor. As a result, many CME endeavors have become extremely labor intensive for CME providers, with notable frustration from all stakeholders.

When you consider the tightened rules for engagement with industry, keep in mind that many of the vendors with whom you interact have no say in the rules they must follow, and that what may have been okay in the past is most likely no longer allowed. In an effort to continue to appropriately support educational opportunities, there must be collaborative effort from the vendor, the sponsoring organization/society and the CME provider. In addition, it seems the rules may continue to get even more specific with respect to tracking transparency, even to the point that physicians will be asked by vendors for their provider license numbers when enjoying vendor activities, including lunches. It will be a challenge to keep up with the future changes, but they are inevitable.

Please visit the ASE web site to see this month’s Sonographer Volunteer of the month – Sue Maisey, MBA, RDCS, FASE. Sue is the Director of Non-Invasive Cardiology/Arrhythmia Center at St. Lukes’ Episcopal Hospital and will be transitioning as the sonographer representative for Advocacy in June. Please visit the web site to learn more about Sue.