Washington Post Profiles Akin Gump’s Health Care Innovations Practice
Akin Gump’s new health care innovations practice was featured in The Washington Post article “With health lobbying team from Patton Boggs, Akin Gump poised for new business.”
The practice, the article notes, is aimed at “helping pharmaceutical companies and medical device makers navigate roadblocks” between the Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS) whose rules are often “at odds with one another.” The FDA determines whether a drug or treatment is safe and effective, while CMS determines whether it should be covered by Medicare.
Senior policy advisor Todd Tuten said he and his colleagues are trying to “connect the dots between FDA and CMS decision-making” where, for several years, there has been a “growing disconnect in the minds of some companies bringing new treatments and products to market … between approval of a product and actual coverage by government-funded health care programs.” As an example of the type of work the group does, Tuten cited a 2006 case on behalf of Kos Pharmaceuticals, the maker of the cholesterol drug Niaspan. The medication was approved by the FDA as a prescription drug, but CMS considered it a prescription vitamin, making it ineligible for coverage under Medicare. CMS later reversed course after the team gathered and presented its case.
The innovations practice also includes health care and life sciences practice partner Nathan Brown, a former FDA lawyer; health policy practice partner Karen Thiel and senior policy advisor Heide Bajnrauh; and consultant Lu Zawistowich. Brown points out the group was not created as a direct response to the Affordable Care Act. Instead, it seeks to represent those entering the health care industry for the first time, encouraged by incentives written into the law.
As an example, the law expanded incentives for technology companies performing certain functions, such as the production of software that helps doctors diagnose or treat patients. Brown says many of these companies are not familiar with the regulatory regimes of the health care industry and “need help thinking through whether they want to be in the U.S. market, how are they positioning their product, will it result in a need for approval by the FDA, and are they interested in reimbursement by Medicare and Medicaid in a way that would shape their product?”
To read more about the group that joined Akin Gump from Patton Boggs, please click here. To read more about Nathan Brown’s arrival at the firm, click here. To read more about our health care innovations practice, please click here.