Health and Human Services announced a final rule from the Centers for Medicare and Medicaid Services (CMS) that will require direct-to-consumer television advertisements for prescription pharmaceuticals covered by Medicare or Medicaid to include the list price if that price is equal to or greater than $35 for a month’s supply or the usual course of therapy.

In May 2018, the Trump administration introduced the American Patients First blueprint to bring down prescription drug prices. The blueprint laid out four strategies for solving the problems patients face: boosting competition, enhancing negotiation, creating incentives for lower list prices, and bringing down out-of-pocket costs.

Less than a year later, this final rule has been published to implement the vision laid out in the blueprint. Up until now, drug companies were required to disclose the major side effects a drug can have.

The new rule takes effect in 60 days, The information should appear in text large enough for most people to read and include a statement that patients with health insurance may pay a different sum.

The rule allows companies to include list prices of competitor products, and says HHS will publicize companies that create false or misleading ads. But primary enforcement will be left to industry. If a drug company fails to include required information, a competitor can file suit under the deceptive and unfair trade practice provisions of the Lanham Act.

HHS Secretary Alex Azar told reporters he could not provide an estimate of whether or how much the rule would change drug prices because “the behavioral aspects of this are too unpredictable” to quantify. But when combined with other steps the administration is taking on drug costs, the rule will lower medication prices, he said.

He dismissed statements from drug companies that the ads could cause some insured patients to stop filling their prescriptions out of the mistaken belief the drugs would cost them too much.

“If a drug company is afraid that their prices are so excessive and abhorrent that they will scare patients away from using their drugs, well they ought to look inside themselves and think about whether they should be lowering their prices,” Azar said.

“If you are ashamed of your drug prices, change your drug prices, it’s that simple,” he said.

The drug lobby PhRMA has been pushing a different plan that would not put prices directly in ads, but direct patients to more nuanced information, such as a website that includes the drug’s list price, an expected range of patient out-of-pocket costs and financial support available to patients.

PhRMA has as indicated it may mount a First Amendment challenge to the administration’s plan – but HHS says it believes the rule is consistent with Supreme Court precedent.

The drug industry spent more than $5.5 billion on advertising in 2017, including nearly $4.2 billion on television ads, according to HHS.