PhRMA sued HHS over a rule set that would require drugmakers to pay higher rebates to state Medicaid programs unless they ensure that patients are able to keep all financial assistance for themselves.
A district court judge has struck down a federal rule that opponents say would have made it harder for pharmaceutical manufacturers to offer cost-sharing assistance to commercially insured patents.
Reuters reported that U.S. District Judge Carl Nichols in Washington, D.C., sided with the Pharmaceutical Research and Manufacturers of America (PhRMA), ruling that the U.S. Department of Health and Human Services overstepped its authority when it passed the rule in 2020.
Recommended For You
"In recent years, some insurers have established so-called accumulator adjustment programs, in which they do not count assistance toward patients' deductibles and out-of-pocket maximums," according to Reuters. "Such programs effectively capture some of the assistance for insurers instead of patients."
PhRMA sued HHS in May 2021 after the department's Center for Medicare and Medicaid Services adopted a rule set to take effect in January 2023 that would require drugmakers to pay higher rebates to state Medicaid programs unless they ensure that patients are able to keep all financial assistance for themselves.
PhRMA —the largest drug industry group in the United States — argued that the Medicaid statute defines the "best price" as a price offered by drugmakers to health insurers and does not allow any accounting for insurers capturing patient assistance. Nichols agreed, writing in his decision for Pharmaceutical Research and Manufacturers of America v. Becerra, U.S. District Court, District of Columbia that the rule "stretches the statutory text too thin."
"Today's decision to vacate the patient assistance penalty … is a win for patients," PhRMA president and chief executive officer Stephen J. Ubl said in a statement. "Manufacturers provide patient assistance to do just that — assist patients and address gaps in insurance — but instead insurers are siphoning that money away for themselves. We will continue to work with policymakers on solutions that make medicines more affordable and lower what Americans pay out of pocket."
America's Health Insurance Plans (AHIP) has also spoken out against these programs, arguing that copay coupon programs are a tactic used by pharmaceutical companies to keep prices high. "Policymakers should ban these promotions and other third-party payments for brand-name drugs when a less expensive alternative is available to stop manipulating patients – and the market – for Big Pharma's profit," the organization wrote earlier this month. "Another solution would be to require drugmakers to offer those coupons to all patients for the full year."
Reuters noted that HHS did not respond to a request for comment.
© 2025 ALM Global, LLC, All Rights Reserved. Request academic re-use from www.copyright.com. All other uses, submit a request to [email protected]. For more information visit Asset & Logo Licensing.
