Bloomberg Quotes Kelly Cleary on Infrastructure Deal’s Impact on Drug Rebate Rule Fight

Akin Gump health care and life sciences partner Kelly Cleary has been quoted in the Bloomberg article “Infrastructure Deal Puts Fight Over Drug Rebate Rule in Peril.” The story reports that a deal in the Senate on infrastructure legislation could put an end to a lawsuit challenging the rule governing payments that drugmakers make to pharmacy liaisons. Instead, the article says, the savings from those payments could be put toward billions of dollars in infrastructure and health care improvements.

The current infrastructure proposal, according to Bloomberg, would delay the rule’s implementation until 2026, leaving the pharmacy benefit managers who are challenging it with less of a basis for the lawsuit.

Cleary, a former Deputy General Counsel at the Department of Health and Human Services (HHS) and Chief Legal Officer for the Centers for Medicare & Medicaid Services, stated that the delay should not affect the plaintiffs’ standing “since the alleged injuries are no less real.” It could, however, affect how relevant the suit is right now. Pushing back the effective date by many years, she pointed out, “may also change plaintiffs’ incentives to continue the litigation at this time.”

Cleary added that Congress’s use of the rule to pay for infrastructure could be seen as an endorsement of the regulation and HHS’s authority to issue it. “You can imply Congress’s views as to whether or not the rule itself is consistent with congressional intent and HHS’s statutory authority,” she said.