On October 7, technology company Kalderos Inc. filed a lawsuit in the U.S. District Court for the District of Columbia against HHS alleging that HRSA’s contract pharmacy policy is unlawful. The complaint refers to HRSA’s May 17 letter sent to manufacturers notifying them that their unlawful contract pharmacy policies have resulted in overcharges to covered entities that could subject the manufacturers to civil monetary penalties. Kalderos did not receive one of these letters but still alleges that the letter and HRSA’s “new” contract pharmacy policy harm Kalderos by “substantially reducing the demand for its services”. Kalderos asks the Court to set aside HRSA’s contract pharmacy policy and that the agency be prohibited from taking any enforcement actions based on that policy.
In 2020, Kalderos introduced a new “340B Pay” platform which, if implemented, would fundamentally change how the 340B drug discount program operates – shifting a manufacturer’s responsibility from providing a 340B discount at the point of sale to paying a rebate after the drug is purchased, dispensed, and billed. On November 13, 2020, 217 members of the House of Representatives signed a bipartisan letter to former Secretary of HHS Alex Azar expressing concern over Kalderos’ attempts to fundamentally change how the 340B program operates. However, Kalderos alleges in its complaint that it was previously advised that “HRSA had recommended to [HHS] that its [340B Pay] model be acknowledged as entirely consistent with the 340B statute.” Kalderos offers no evidence of HRSA making such a recommendation.