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Photo: John Smith/VIEWpress

Pfizer cannot directly or indirectly pay out-of-pocket costs for Medicare patients to get the company's $225,000-a-year heart drug because doing so would violate federal kickback law, a U.S. district judge ruled Thursday.

Why it matters: The ruling in this closely-watched case means pharmaceutical companies still cannot cover the copays and other costs of their drugs for patients who are enrolled in government insurance programs because it would be viewed as an illegal inducement.

The big picture: Medicare is prohibited from setting drug prices, although Democrats are attempting to change that, so the federal program uses cost-sharing as a check on prices.

  • Pfizer argued the out-of-pocket costs are preventing Medicare patients from getting a drug they need. The drugs in question, Vyndaqel and Vyndamax, also known as tafamidis, treat a rare form of heart failure that mostly occurs in older people who are on Medicare.
  • Federal attorneys and auditors said Pfizer "priced itself out of the market" by listing the drug at $225,000. They also warned a ruling in Pfizer's favor would lead to a "gold rush" of other pharmaceutical companies paying patients' copays for their drugs while getting guaranteed reimbursement from Medicare at almost any price they set.

What they're saying: Legal experts said the ruling is unsurprising because federal law clearly does not allow drug makers to induce people on Medicare to take their drugs, either by directly paying their copays or by indirectly funding a charity and telling the charity to pay those copays.

  • Pfizer sent a statement, saying: "We are disappointed in the ruling and believe that providing copay assistance to patients who have been prescribed tafamidis through Medicare Part D represents an equitable way to lower out-of-pocket costs for this breakthrough treatment."

The bottom line: "While there may be an administrative or legislative remedy to the problems Pfizer seeks to correct here, the remedy does not lie with the court," Judge Mary Kay Vyskocil wrote in her ruling.

Go deeper

Appeals court scraps order mandating COVID protections for immigrant detainees

ICE detention center in downtown Los Angeles. Photo: Mark Ralston/AFP via Getty Images

Judges on a federal appeals court Wednesday voted 2-1 to overturn an order requiring authorities to monitor and possibly release immigrants being held at detention centers if they are at high-risk for long term COVID-19 complications, the Los Angeles Times reports.

Why it matters: In its ruling, the San Fransisco-based panel said a federal district judge overreached in 2020 when he issued a preliminary injunction requiring the monitoring. The Trump administration appealed that ruling, and Biden's Justice Department continued to argue against it when he took office.

Updated 2 hours ago - Health

NYC firefighters union urges members to defy mayor's vaccine mandate

New York City Mayor Bill de Blasio. Photo: Michael M. Santiago/Getty Images

The president of New York City's firefighters union told reporters Wednesday that he's advised unvaccinated members to ignore Mayor Bill de Blasio's COVID-19 vaccine mandate for city workers, per Reuters.

Why it matters: Under de Blasio's order that's due to take effect Friday, unvaccinated city employees would be placed on unpaid leave. But Uniformed Firefighters Association head Andrew Ansbro said he told members that "if they choose to remain unvaccinated, they must still report for duty," according to Reuters.

3 hours ago - Health

Study: Common antidepressant guards against COVID hospitalization

A COVID-19 intensive Care Unit in Rio De Janeiro, Brazil on May 27, 2021. Photo: Fabio Teixeira/Anadolu Agency via Getty Images

The readily available antidepressant fluvoxamine significantly reduced COVID-related hospitalizations, according to a large study published Wednesday.

Why it matters: The clinical trial suggests that a cheap, readily available drug could dramatically reduce serious illness and death when prescribed early.