Politics, Policy & Law

Fate of Trump’s 11th hour drug price rules uncertain

Legal and logistic challenges could block implementation of most favored nation, rebate rules

Legal and logistic challenges could block implementation of the most favored nation and rebate rules.

If they withstand withering legal challenges from the biopharmaceutical industry, hospitals and medical groups, and overcome steep logistic obstacles, rules released by the Trump administration Friday could reshape the U.S. drug pricing landscape. The Trump administration has not had much success in defending controversial regulatory policies from legal assaults.

At a White House press conference, President Donald Trump announced a final interim rule  “most favored nation” (MFN) that caps Medicare Part B drug reimbursement for 50 drugs at the lowest price paid by any developed country. The Trump administration estimates that the rule would yield savings to taxpayers, and reduced drug company revenues, of more than $85 billion over seven years.

Trump also announced a rule scrapping rebate payments to PBMs and insurance companies for Medicare Part D drugs.

The White House set Jan. 1, 2021 as the implementation date for both the MFN and rebate rules, a timetable that would be extraordinarily difficult to meet without causing disruption to drug supplies and payments to physicians and pharmacies.

In a move taken without FDA’s advance knowledge, Trump used the press conference