Healthcare regulations could be thrown into question following a Supreme Court decision last month that curtails a different agency's authority to interpret laws.
While the ruling may not have much of an immediate impact on healthcare, it creates a landscape of uncertainty that could hamper healthcare companies that need regulatory clarity to plan ahead.
The Supreme Court ruled that a method the Environmental Protection Agency created to cap emissions went beyond the scope of the agency's congressionally delegated authority. The 6-3 opinion written by Chief Justice John Roberts indicates the current court majority believes big policy questions need to be left to the legislative branch. …
The Supreme Court ruled the EPA policy counted as "major" because of its economic impact. But the high court didn't rely on this doctrine in decisions this term on whether HHS correctly interpreted the law for disproportionate share hospital payments or the 340B drug discount program, each of which is worth billions of dollars, said Robert Wanerman, an attorney at law firm Epstein Becker Green. …
But the fuzziness of the major questions doctrine also means it can't be seen as an automatic win for those trying to challenge health regulations they don't like, Wanerman said. "You're probably gambling a bit if that's what you're going to hang your hat on," he said.
Whether something is a major question is a "tough call to make because the vast majority of what CMS does already fits within either an express congressional mandate or it fits within a long-recognized area where they have regulated for many years," Wanerman said.
Wanerman doesn't believe the EPA decision and its repercussions for judicial review of regulations will have much of an immediate effect on healthcare regulation. But he does anticipate the ruling will prompt more challenges to federal rules. HHS and CMS are likely to pay closer attention to statutory text when writing regulations, he said. Regulators may also be more specific when advising congressional committees on healthcare legislation, he said.
"They may say, 'All right, we kind of see this coming. We want to build in more specific language so that we don't get hamstrung by litigation,'" Wanerman said.