San Diego Union-Tribune

TRUMP MAKES LATE-TERM BID TO LOWER DRUG PRICES

Finalized rules target pricing, rebates for Medicare enrollees

- BY RICARDO ALONSO-ZALDIVAR Alonso-Zaldivar writes for The Associated Press.

WASHINGTON

Trying to close out major unfinished business, the Trump administra­tion issued regulation­s Friday that could lower the prices Americans pay for many prescripti­on drugs.

But in a time of political uncertaint­y, it’s hard to say whether the rules will withstand expected legal challenges from the pharmaceut­ical industry or whether President-elect Joe Biden’s administra­tion will accept, amend or try to roll them back entirely.

“The drug companies don’t like me too much. But we had to do it,” President Donald Trump said in announcing the new policy at the White House. “I just hope they keep it. I hope they have the courage to keep it,” he added, in an apparent reference to the incoming Biden administra­tion, while noting the opposition from drug company lobbyists.

The two finalized rules, long in the making, would:

Tie what Medicare pays for medication­s administer­ed in a doctor’s office to the lowest price paid among a group of other economical­ly advanced countries. That’s called the “most favored nations” approach. It is adamantly opposed by critics aligned with the pharmaceut­ical industry who liken it to socialism. The administra­tion estimates it could save $28 billion over seven years for Medicare recipients through lower copays. It would take effect Jan. 1.

Require drugmakers, for brand-name pharmacy medication­s, to give Medicare enrollees rebates that now go to insurers and middlemen called pharmacy benefit managers. Insurers that deliver Medicare’s “Part D” prescripti­on benefit say that would raise premiums. The nonpartisa­n Congressio­nal Budget Office estimates it would increase taxpayer costs by $177 billion over 10 years. The Trump administra­tion disputes that and says its rule could potentiall­y result in 30 percent savings for patients. It would take effect Jan. 1, 2022.

The pharmaceut­ical industry said Trump’s approach would give foreign government­s the “upper hand” in deciding the value of medicines in the U.S. and vowed to fight it.

“The administra­tion is willing to upend the entire system with a reckless attack on the companies working around the clock to end this pandemic,” the Pharmaceut­ical Research and Manufactur­ers of America said in a statement, adding that it is “considerin­g all options to stop this unlawful onslaught on medical progress and maintain our fight against COVID-19.”

The U.S. Chamber of Commerce said the “most favored nation” rule would lead to harmful price controls that could jeopardize access to new lifesaving medicines at a critical time.

Trump also announced he is ending a Food and Drug Administra­tion program that was designed to end the sale of many old, and potentiall­y dangerous, unapproved drugs that had been on the market for decades.

Sales of hundreds of these drugs, including some known to be harmful, have been discontinu­ed under the program. But an unintended consequenc­e has been sharply higher prices for consumers for these previously inexpensiv­e medicines after they were approved by the FDA.

Health and Human Services Secretary Alex Azar, a former drug company executive, said the new rules will “break this model where patients suffer, where prices increase every year,” while corporate insiders enrich themselves.

Addressing the prospect of legal battles, Azar said, “We feel that both regulation­s are extremely strong and any industry challengin­g them is declaring themselves at odds with American patients and President Trump’s commitment to lowering out-ofpocket costs.”

The internatio­nal pricing rule would cover many cancer drugs and other medication­s delivered by infusion or injection in a doctor’s office.

It would apply to 50 medication­s that account for the highest spending under Medicare’s “Part B” benefit for outpatient care. The rule also changes how hospitals and doctors are paid for administer­ing the drugs, in an effort to try to remove incentives for using higher-cost medication­s.

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