As I write this, the presidential candidates are crusading through the neighboring state of New Hampshire in anticipation of what promises to be an exciting and unpredictable primary and election year. One thing is certain: healthcare is a top priority issue for candidates and voters.
While conventional wisdom holds that Democratic administrations are tougher on the pharmaceutical industry, the regulatory environment certainly heated up under the current Republican administration. Regardless of who wins the Presidency, I think it's safe to say that the government crackdown on the continuing medical education and pharmaceutical industries will intensify. A few indications:
Under the Phase III Stark Law, which went into effect December 2007, free, hospital-based CME is considered to be remuneration to physicians and can violate the law, depending on various factors. Attorney Seth Lundy, a specialist in healthcare regulations, expects the federal government to ramp up its scrutiny of hospital/physician relationships in the near future. (See page 9.)
The Physician Payments Sunshine Act, sponsored by several U.S. senators, would require pharmaceutical companies to disclose all their expenditures on physicians, including CME. While the legislation stalled at the end of 2007, CME experts who are monitoring developments expect the law to be taken up for a vote in 2008.
There is increasing activity on the state level as well. In addition to laws limiting or prohibiting pharma companies' gifts to physicians and requiring companies to disclose expenditures on doctors, several states have proposed legislation that would require the licensing and training of pharmaceutical sales reps.
Moving ahead into 2008, healthcare education and meeting professionals need to explore new ways of developing programs, given the current regulatory environment. I'm encouraged by two examples we feature in this issue. George Mejicano, MD, at the University of Wisconsin School of Medicine and Public Health, has spearheaded a groundbreaking CME initiative, bringing together nine organizations from across the country to create a major tobacco-cessation program, funded by Pfizer with a $12.5 million grant. By aiming to measure the highest level of outcomes — the effect on population health — this project not only exemplifies the goals of the new Accreditation Council for CME criteria, it also has the potential to demonstrate to the government the positive power of pharma-funded CME. (See page 12.)
On the other end of the spectrum, Memorial Sloan-Kettering Hospital disallowed commercial support for CME in January 2007, leaving CME staff afraid the program would be decimated. One year later, the program is thriving — and there have been beneficial side effects. Without grant money, administrators scaled back on advertising to reduce costs, and in the process they discovered marketing opportunities in the hospital that they hadn't seen until they were forced to change their approach. They've also added new courses that were not feasible when they relied on commercial support. (See page 24.)
To rephrase the old saying, sometimes it's not until the door shuts that you find a window. I encourage you to face forward and figure out how you can be effective in achieving your goals — educating healthcare professionals and improving patient care — despite the ever-changing, restrictive regulatory arena. I'm eager to hear about your innovations.
Best wishes for a happy, healthy, and successful 2008.