Call it the New Age of Transparency and Accountability: So far this year, two states—Massachusetts and Vermont—have enacted strict laws that codify and regulate the interactions between health care providers and pharmaceutical sales and marketing representatives. Whether you consider such legislation “draconian” (as some critics do) or essential, it appears to be part of a trend that advocates hope will continue.
While lauding Massachusetts and Vermont for “taking the lead” in these matters—going beyond other states’ laws that allow gifts and payments from pharmaceutical and device manufacturers to health care providers, as long as they are disclosed—Howard Brody, MD, PhD, Director of the Institute for the Medical Humanities at the University of Texas Medical Branch in Galveston, laments that legislation has been necessary.
“I think it would really be ideal if professionally, we just decided among ourselves—doctors, nurse practitioners, physician assistants, and so on—that we would not accept this money,” Brody says. “Because it’s tainted money, really, and it compromises our commitment to our patients.”
Massachusetts: The Microcosm
The Massachusetts code of conduct—officially designated “105 CMR 970.000: Pharmaceutical and Medical Device Manufacturer Conduct”—is outlined in a 13-page document available at the Web site for the state’s Department of Public Health (www.mass.gov/dph). The code applies to industry interactions with any health care provider licensed to practice in Massachusetts—even if the encounter occurs in another state (say, at a national conference). Helpfully, there are three “frequently asked questions” sections in which the finer points of the regulations are explained, often with specific examples.
In a nutshell, the code prohibits gifts of entertainment or recreation (eg, trips, tickets to concerts or sporting events); complimentary branded items (eg, pens, mugs, calendars); and meals, unless certain circumstances are met. All provided meals must be “modest” and “occasional,” must take place in the practitioner’s office or hospital setting, and must be accompanied by an informational presentation. Items that have potential benefit to patients—such as drug samples or demonstration models of medical devices—are permissible under the new regulations.
With regard to sponsorship of continuing medical education (CME) programs, the code stipulates that pharmaceutical and medical device manufacturers may not provide financial support for travel, lodging, meals, or personal expenses to nonfaculty health care providers attending such events. They are also prohibited from sponsoring or paying for CME that does not comply with the Standards for Commercial Support set forth by the Accreditation Council for Continuing Medical Education or an equivalent accrediting body. Further, companies are also barred from providing “any advice or guidance to the CME provider regarding the content or faculty for a particular CME program funded by the company.”
Pharmaceutical and medical device manufacturers are required to disclose “the value, nature, purpose, and particular recipient of any fee, payment, subsidy, or other economic benefit with a value of at least $50 to any covered recipient in connection with the company’s sales and marketing activities.” Disclosure reports must be filed by July 1 each year, beginning in 2010, and must be accompanied by a $2,000 fee. The first reports will cover the six-month period from the regulations’ implementation on July 1, 2009, through December 31, 2009. Subsequent annual reports will cover the entire previous calendar year.
While the demise of the “free lunch” has received the most media attention, it is the CME restrictions that may pose the biggest challenges to clinicians in Massachusetts. Both the NP and PA professional organizations in the state have already started planning how they will continue to provide CME opportunities to their members while complying with the code.
“Since the change in attitude toward pharmaceutical company funding of CME events, we have had to be more creative in how we provide CME to our members,” says David Probert, PA-C, the Massachusetts Association of Physician Assistants (MAPA) Delegate to the American Academy of Physician Assistants, who has served on MAPA’s CME committee. “The continued operation of our professional organization will rely more on member support—ie, dues—than in the past.” MAPA is applying for grants from nonpharmaceutical sources, including the AAPA, local hospitals, and other employers of PAs.
The Massachusetts Coalition of Nurse Practitioners (MCNP) is also working to develop educational programs in partnership with larger institutions and universities. “We’re looking at how we can develop quarterly educational offerings … that we could open to our members for a small fee,” says MCNP President Nancy O’Rourke, MSN, ACNP, ANP, RnC, FAANP. “We haven’t had to charge them anything for their educational opportunities, but at this point, we’re going to have to start. It’s probably going to be a nominal fee, but it still has to cover the cost of putting on the program. Speakers for these programs typically get a large honorarium, and that’s where the pharmaceutical companies were helping us—paying that honorarium.”