Trump signs limited drug price orders after last-minute debate


But ambitious plans are fraught with limitations. The reimbursement order comes with a caveat that any plan cannot increase seniors’ premiums, the unfeasible problem that led the administration to drop its original reimbursement rule last year.

And while Trump called the so-called favored nations rule, which ties senior citizen costs for certain doctor-administered drugs to lower prices paid abroad, the “grandfather” of policies announced today, also vowed to abandon the plan if drug companies could come up with a better option within the next month.

Pharmaceutical executives will meet at the White House on Tuesday.

Orders are not immediately enforceable. Health officials have been working on ways to implement some of the proposals, namely guidelines for states to implement import plans. But it is unlikely that it can be finalized before the November presidential election, especially since the most-favored-nations plan would not progress for at least a month.

A third order will encourage the importation of cheaper drugs by states, wholesalers, and pharmacies, an effort that has been underway since last year. A fourth runs clinics that qualify for large drug discounts under a government program for low-income patients. to pass savings on insulin and EpiPens directly to those patients But it will only apply to approximately 1,000 community health centers, not hospitals that are often branded as diverting patient discounts to other programs.

The deployment culminated a frantic 48 hours for the Trump administration, as officials debated what policies should be included in the approval of executive orders until just hours before the president was scheduled to sign them.

The fate of the so-called refund rule was in question until the last few hours. HHS Secretary Alex Azar and Chief of Staff Mark Meadows have endorsed the policy. But Vice President Mike Pence and other White House officials expressed concern that the rule would increase seniors’ premiums, and as of Thursday it was no longer on the table.

The final decision was made so late that various health officials learned what the final orders contained when the president publicly announced them.

On Wednesday, Trump gave the green light to three orders, including the importation, the insulin plan for needy patients, and the favored nations rule that links certain Medicare Part B payments to lower prices for those drugs paid abroad. . At the time, he rejected a resurrection of the refund rule that has divided his administration for more than a year.

But those plans were thrown into limbo the next day amid intense outside pressure from the pharmaceutical industry, and renewed attempts within the administration to convince Trump to reconsider his opposition to the refund rules, three people close to the process said.

The internal debate over the policies Trump should demand finally spilled over into Friday morning, and the refund rule was finally added to the mix. “It’s super chaotic,” said one person with knowledge of the round-trip changes to POLITICO hours before Trump formally announced the executive orders.

‘A very difficult request’

The Favored Nations Plan, which links Medicare Part B drug payments to a lower international price basket, is vehemently opposed to the pharmaceutical industry and many conservative groups.

Trump gave the pharmaceutical industry a month to come up with an alternative plan to remove the rule, which the administration once projected would save 30 percent on certain drugs, which has divided his party and the administration. If drug manufacturers are successful, “we may not need to implement the fourth executive order, a very difficult order,” he said.

Patient advocacy organizations have also expressed concern, saying that the policy would not actually reduce costs for patients but would reduce or decrease incentives to develop new therapies.

“Right now the White House and Trump [are] trying to cut costs on Medicare and do it at our expense, “Maria Town of the American Association for People with Disabilities said in a call to reporters ahead of the event.

The original favored nations proposal, later called the International Price Index, has been in the White House budget office since last summer. Last fall, Azar said the administration was reworking the rule because Trump “did not find it satisfactory.”

With the presidential elections less than four months away, the industry and analysts are skeptical that any major move can be completed before the November vote.

“Drug EOs are a way to give the appearance of movement on Trump’s price agenda without actually doing anything,” wrote Rob Smith of Capital Alpha Partners in a note, adding that the original government of favored nations has languished with budget officials for over a year. year. “A more impactful step would be to issue this actual proposed rule and begin the process of finalizing it rather than holding what amounts to a glorified press conference.”

The Trump administration released a draft plan to allow states to import cheaper drugs from Canada at the end of last year. But the regulations have not been finalized and most of the responsibility falls on the states to demonstrate that they can save money and ensure the safety of medicines. While several states, including Florida, Maine, and Colorado, have passed laws to import drugs, none have yet submitted a plan to the federal government.

Trump thanked Florida Governor Ron DeSantis, who attended the signing, on Friday for being at the forefront of import efforts.

“It is something that Ron and I have been discussing since Ron was elected,” the president said of his former ally. “It takes a long time from a legal point of view … we have it all figured out.”

But critics of drug imports have called it a trick that would not reduce costs for patients. Canada itself has been reluctant to board, and officials noted that the country does not have enough supply to meet the needs of the United States and would not be responsible for ensuring security.

The fourth order would force federally qualified health centers to collect massive pharmaceutical discounts through a program called 340B to pass discounts on insulin and EpiPens to low-income or uninsured patients. But it is a limited version of a policy that has been on the wish list of pharmaceutical lobbyists and a priority for critics of the program, mostly Republicans, in Congress.

The order does not apply to hospitals that have been the focus of critics’ anger, but only to around 1,000 community health centers. By law, facilities that participate in the 340B program can use the money they get from discounts for almost anything that works. patients in need But critics accuse some hospitals of taking advantage of lax rules to fill their operating budgets with little benefit to their community.