The Physician Payments Sunshine Act is part of the Patient Protection and Affordable Care Act, all of which hangs in the balance Thursday morning when the U.S. Supreme Court will likely rule on the constitutionality of all or parts of the package.
One legal possibility is that the court could decide to defer a decision until the law is fully implemented in 2014, but the betting line has the nine justices making history, one way or another. And, yes, there is a betting line.
The Sunshine Act requires pharmaceutical and medical device companies to report payments made to doctors and teaching hospitals. It is designed to give patients and others more information and shed light on potential conflicts of interest. The question is whether a doctor paid by a company is more inclined to prescribe that company's drug over a competitor's drug or no drug because of his or her financial relationship with the first company, regardless of the effect on the patient.
The Sunshine Act was the topic of a panel discussion Wednesday afternoon at the Drug Information Association's 48th annual meeting at the Philadelphia Convention Center. The meeting concludes Thursday morning.
The panelists had differing opinions on the Sunshine Act, especially the complexity and tightness of rules that are still being written by the personnel at the Department of Health and Human Services, but most thought more disclosure was coming regardless of Thursday's Supreme Court decision.
"It's very hard for me to see how transparency and disclosure can be unconstitutional," said Dr. Dan Carlat, director of the Pew Prescription Project. He added that if the court overturns the current law, a subsequent law would mimic the essence of the Sunshine Act.
"I think transparency is here to stay," said Kendra Martello, an attorney with the Pharmaceutical Research and Manufacturers of America (PhRMA), the lobbying group for brand-name drug manufacturers. "If the whole thing comes down, there will be a lot of questions with the states, because a lot of the trends toward transparency started with the states. Companies have made significant investments in data collections. Those investments are staggering and I think transparency is here to stay."
Six states had transparency requirements before the federal law was signed by President Obama in March 2010.
The panel moderator was John Kamp, who is director of the Coalition for Healthcare Communication. Earlier in his career, Kamp taught constitutional law at the University of Tulsa Law School.
Kamp predicted that the Supreme Court would uphold the law by a vote of 6-3 with Chief Justice John Roberts writing the majority opinion.
"The chief being the chief will want to write this one," Kamp said. "But the push for transparency in our business will continue. In effect, we are all government contractors. The idea that the American people have a right to see where the money goes - one way or another - that push is going to happen. If there is a pause, there will be sober, second thoughts. The idea that we have to count bagels and or every separate cup of coffee [given to doctors] is not a reasonable, good idea. The costs of implementing that is way too high vs. the benefits."
John Lewis, vice president for public affairs with the Association of Clinical Research Organizations (ACRO), spoke before Kamp and also predicted a 6-3 vote to uphold the law with Roberts writing the majority opinion.
"However," Lewis said, "I would add that in January with President Romney, a Republican Senate and Republican House, they will repeal the law."
Sandi Dennis, who is deputy general counsel for the Biotechnology Industry Organization (BIO), grew up in Philadelphia and was scheduled to have dinner with family after the panel before returning to Washington to await Thursday's decision.
"I might be one of the few people who think it might be upheld," Dennis said, speaking before Kamp and Lewis. And perhaps echoing the thought running through the minds of many Americans, she added, "Plus, I think it will drive us all crazy to have to do everything again."