Howard Sklamberg and Heide Bajnrauh Speak with Corporate Counsel on Health Care Trends in 2018
Corporate Counsel has featured Akin Gump health partner Howard Sklamberg and senior policy advisor Heide Bajnrauh in the article “Akin Gump Health Care Leaders Share 4 Important Trends for 2018,” discussing what in-house lawyers within the industry should keep in mind in the new year, and beyond. The remarks, as the article notes, follow what was a year of uncertainty in 2017.
Sklamberg first spoke about the topic of FDA enforcement, pointing out that FDA Commissioner Scott Gottlieb has “embraced the role of enforcement in public health.” He has also talked about fraudulent therapies, Sklamberg said, and about “the need for enforcement in dangerous imports, and he’s proceeded with the reorganization of the Office of Regulatory Affairs, which works on enforcement.”
Sklamberg added, that “if companies thought that there was going to be a pullback on FDA enforcement, I think that would be an incorrect assumption. … Gottlieb has affirmatively said that enforcement is important for public health and that enforcement is an important function.”
Sklamberg also spoke about an increase in the FDA’s pre-certification programs, which he said would be an important step in reducing regulatory burdens. He predicts there will be “a lot more versions of trusted company programs, whether it’s pre-certification or other similarities.” He also advised that companies “would want to be ready for that when pilot programs are announced and be ready to have a record to show that they should be among that list,” since it will be important to be in that group.
Bajnrauh then addressed the topic of rulemaking, which she expects to be the source of additional policy changes. “Some broader policy issues that we normally have not seen coming out of the Centers for Medicare & Medicaid Services through regulations, we are now seeing more and more, so that trend will certainly continue,” she said.
In addition, Bajnrauh expects a heightened emphasis on value-based payment models, whereby health care providers are rewarded with incentive payments for the quality of care they give to people with Medicare. It will be voluntary, however, which, she said, means “there will be more flexibility as to what type of payment models CMS will want to pursue.” That could also lead to skewed numbers, making it difficult to determine “whether or not a pilot would have been successful or not on a national or broader scale.” In the end, Bajnrauh said “increasing quality will still be a priority for CMS.”