Members of the pharmaceutical industry recently told the Department of Health and Human Services they are concerned about the uncertainty of changing compliance regulations.
But Mary Riordan, senior counsel at the department’s Office of Inspector General, said Monday that she hopes those worries will now be settled as the presidential election has been decided and final regulations, including those set forth in the Affordable Care Act, are put in place.
Riordan spoke at the 13th Annual Pharmaceutical Regulatory and Compliance Congress on Monday in Washington, D.C., relaying the results of a round table with members of the IG’s office and compliance officers at 23 different pharmaceutical companies. The meeting, held in February, brought together 42 compliance officers and 15 members of the IG’s office to talk about corporate integrity agreements, an enforcement tool that allows companies to avoid indictment by agreeing to a number of remedial conditions from the government. Many such CIAs require companies to submit to an outside monitor to ensure they are meeting regulatory requirements.
Riordan said Monday that round table participants’ biggest concern was staying up-to-date on regulatory complexities. The office’s report on the meeting said that many of the round table participants cited the Affordable Care Act’s transparency provisions, including new requirements for companies to report payments to doctors and teaching hospitals and disclose any investment interests in them by doctors.
Riordan also said she was surprised by the number of industry officials asking for more government guidance on the proper use of social media to distribute product information. The round table participants “voiced a consensus that there is a lack of clarity and guidance in these areas.”
Riordan was joined by HHS OIG Chief Counsel Gregory Demske, who recently replaced the long-serving Lewis Morris. Demske offered a broader picture of the IG office’s enforcement over the past decade.
Healthcare costs are hitting $3 trillion a year nationally — a figure larger than the economy of all but four countries in the world, he said. The medical industry estimates that 30 percent of that amount is wasted money. For an agency seeking to root out waste and fraud in federal health care programs, Demske called the statistics “extremely sobering.”
“We at OIG have accomplished a lot, but I don’t know that we can clearly say we have done everything we can do,” he said Monday. “We at OIG will continue to look at ways to use enforcement tools… and challenge you to think about ways your company can think differently and boldly to promote compliance in the way you do business every day.”