President Donald Trump announced a new effort to decrease the cost of in vitro fertilization and other fertility care on Thursday, following through on a campaign promise to help make the procedure affordable for families struggling with infertility.
The executive actions announced by Trump and his Cabinet officials in the Oval Office on Thursday strike a middle ground that appears likely to minimize the blowback from anti-abortion advocates, who have fought for months to prevent Trump from imposing coverage mandates for IVF through Obamacare.
“We’re here today to announce a historic victory for American women, mothers, and families,” Trump said Thursday. “With the actions I will outline this afternoon, we’ll dramatically slash the cost of IVF and the treatment and many of the most common fertility drugs for countless millions of Americans, prices are going way down, way, way down.”
The new White House effort is meant to increase insurance coverage of fertility care and lower drug prices for hormone-stimulating medications necessary for each IVF cycle.
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In the U.S., data suggests that more than 10 million American women have struggled to conceive. A single cycle of IVF can cost anywhere from $12,000 to $30,000, a prohibitive cost for many couples.
The president signed an executive order in February that directed policy recommendations to protect IVF access and aggressively reduce out-of-pocket and health plan costs for such treatments within 90 days.
That deadline passed without a firm plan in place that was accessible to the public, but the Thursday announcement appears to be part of the administration’s efforts to boost the nation’s fertility rate.
Conservative groups have split on how far the Trump administration should go in subsidizing IVF treatment, largely objecting to the destruction or discarding of embryos created in the IVF process that are not used by couples.
Anti-abortion advocates in particular have been opposed to making IVF and other assisted fertility care procedures a mandated insurance benefit. Yet, the White House appeared confident that the new initiatives would help couples give birth to more babies.
“The result will be healthier pregnancies, healthier babies, and many more beautiful American children. It’s a big factor. It’s a big deal,” Trump said.
New category of insurance benefit
As part of the new deal, the Department of Labor, the Treasury Department, and Health and Human Services will issue guidance offering fertility benefits outside of major medical insurance plans as an optional add-on benefit.
“We’re also taking historic steps to vastly expand access to insurance coverage for fertility care, including IVF, something that, as you know, was not covered,” said Trump. “Effective immediately, for the first time ever, we will make it legal for companies to offer supplemental insurance plans specifically for fertility.”
Following concerns from anti-abortion groups of a coverage mandate similar to contraception under Obamacare, the White House opted to ensure that IVF and other fertility care coverage is entirely optional for employers and that there will be no subsidies for employers to offer this type of benefit.
“We believe that there is significant market demand from employers to offer fertility benefits. And so by creating the solution that does that, we think you’re going to have significant market forces that will increase fertility coverage,” a senior administration official told reporters in a briefing Thursday before Trump’s afternoon announcement.
Employers will “determine how much they can afford to spend on fertility benefits, bid out directly to these benefit companies, and offer a cost-certain fertility benefits specifically to those who opt in,” a senior administration official told reporters.
In practice, companies will have the flexibility to offer fertility benefits comparable to additional coverage typically offered by employers, such as dental or vision plans, bypassing complicated issues such as prior authorization for IVF treatments. It will also bring some financial relief to employees with high-deductible health care plans who had to spend exorbitant amounts of money on fertility treatments before employer contributions kicked in.
“By pulling it out of major medical, the employees are able to receive coverage before hitting that deductible in their major medical plan, while allowing the employer and employee to continue to contribute tax-free to that HSA,” said the official. “Which we think is a pretty massive shift towards affordability relative to the way the major medical plans work today.”
Administration officials told the Washington Examiner that employers could begin offering stand-alone fertility care benefits right away if they chose, but that the logistics of setting up these types of coverage options will likely take time.
Premiums for fertility care add-on plans will depend on a multitude of factors, including how much employers are willing to spend, how much employers are willing to spend on their plans, and what services are covered.
“I’m asking all employers to make these new fertility benefit options available to their employees immediately,” Trump said.
Most Favored Nation drug pricing
Trump administration officials also announced Thursday that the Centers for Medicare and Medicaid Services negotiated with the pharmaceutical company EMD Serono to substantially lower the cost of prescription medications essential to the IVF process.
Trump issued an executive action this summer directing CMS to negotiate with drug companies to lower prices for all prescription drugs to bring them in line with the prices of other developed nations, under the threat of increased tariffs for both the companies and other countries if they did not comply.
AstraZeneca and Pfizer each separately announced earlier this month that they were voluntarily willing to lower their prescription drug prices for Medicaid and cash-pay patients. The White House announced alongside those deals a new platform, dubbed TrumpRx, where patients can directly purchase drugs from the manufacturers at MFN prices.
“As part of this agreement, EMD Serrano will list their fertility drugs online at Trump rx.gov at very, very heavily reduced prices, prices that you won’t even believe, and ultimately that’s because of the Favored Nations,” Trump said.
Libby Horne, director of fertility medicine at EMD Serono, said during the Oval Office briefing that Americans “will have access to our leading IVF therapies for an 84% discount off list prices.”
Pharmaceuticals make up a significant portion of the cost of IVF due to the necessary hormone regulation, and Gonal-f is one of the most common medications used currently in the US.
Female patients undergoing IVF typically start the process by using a follicle stimulating hormone, or FSH, injection to allow for multiple eggs to be released during an ovulation cycle. Those eggs are then extracted and used to create embryos for the IVF process.
FSH can sometimes also be used for spontaneous natural conception as well as assisted reproductive technologies like IVF or intrauterine insemination, or IUI.
Senior White House officials told reporters ahead of the announcement that patients under 550% of the federal poverty level, making about $116,000 annually for a couple, would see the price of this drug reduce to $1,200 per cycle, compared to the current $3,400.
Individuals earning more than 550% of the federal poverty level will see their out-of-pocket costs reduced to $1,900 per treatment.
EMD Serono also committed that “all future drugs and everything that it develops and sells in the United States will be offset at Most Favored Nation Prices,” Trump said.
Fast-track approval for a new drug
Food and Drug Administration Commissioner Dr. Marty Makary announced at the White House that EMD Serono company would be getting a fast-track approval for its drug Pergoveris, a recombinant hormone product.
“If approved, Pergoveris would combine two key reproductive hormones in synergy designed to mimic reproductive physiology,” Horne said. “This therapeutic option could mean fewer injections, fewer co-pays and lower self pay cost, all of which make a real difference in the IVF patient experience.”
Makary said earlier this month that pharmaceutical companies would be offered fast-track approvals for new drugs if they committed to having their introductory list price in the U.S. be the same as other developed countries following Trump’s MFN policy.
Senior administration officials told reporters that the drug has already been given approval in other countries and has resulted in half a million successful live births, increasing the success of the IVF process.
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CMS administrator Dr. Mehmet Oz said the accelerated approval process for Pergoveris “will further reduce the price and make this whole process more seamless for the American people.”
