ERISA

Although the Supreme Court has already weighed in on one case regarding states’ ability to regulate PBMs, the top law enforcement officials in more than 30 states are asking the high court to review another case that they claim will remove lingering uncertainty about the limits of states’ authority.

In PCMA v. Mulready, the current case, the Pharmaceutical Care Management Association is challenging an Oklahoma law — the Patient’s Right to Pharmacy Choice Act — which sets geography-based access standards for pharmacy networks. Among other provisions, it also bans PBMs from using discounts or cost-sharing differences to push plan members to certain in-network pharmacies, particularly those owned by that same PBM’s parent company.

Although the Supreme Court has already weighed in on one case regarding states’ ability to regulate PBMs, the top law enforcement officials in more than 30 states are asking the high court to review another case that they claim will remove lingering uncertainty about the limits of states’ authority.

In PCMA v. Mulready, the current case, the Pharmaceutical Care Management Association is challenging an Oklahoma law — the Patient’s Right to Pharmacy Choice Act — which sets geography-based access standards for pharmacy networks. Among other provisions, it also bans PBMs from using discounts or cost-sharing differences to push plan members to certain in-network pharmacies, particularly those owned by that same PBM’s parent company.

A lawsuit filed by an employee against Johnson & Johnson could signal that significant changes in the legal obligations of commercial plan sponsors and PBMs around drug pricing are coming, experts say. The suit alleges that J&J violated its fiduciary obligations as a health plan sponsor under the Employee Retirement Income Security Act (ERISA) of 1974 by overpaying the plan’s PBM for employees’ medications.

If it’s successful, the suit could expose plans, plan sponsors and PBMs to significant, ongoing legal risk, experts say. However, they add that the opacity and complexity of drug pricing dynamics mean that the suit’s success is far from certain.

A lawsuit filed by an employee against Johnson & Johnson could signal that significant changes in the legal obligations of commercial plan sponsors and PBMs around drug pricing are coming, experts say. The suit alleges that J&J violated its fiduciary obligations as a health plan sponsor under the Employee Retirement Income Security Act (ERISA) of 1974 by overpaying the plan’s PBM for employees’ medications.

If it’s successful, the suit could expose plans, plan sponsors and PBMs to significant, ongoing legal risk, experts say. However, they add that the opacity and complexity of drug pricing dynamics mean that the suit’s success is far from certain.

U.S. patients paid an estimated 278% more for prescription drugs than patients in other high-income countries did for the same drugs in 2022, according to a RAND Corp. study. U.S. gross prices for brand-name originator drugs were 422% higher than drugs in the comparison countries, RAND found; after rebates were applied, brand-name drugs still cost more than three times the amount paid in other countries. Unbranded generics were the only category that were not “substantially higher” in price than drugs in other countries. As RAND pointed out, unbranded generics account for 90% of U.S. drug volume but just 8% of total drug spending at manufacturer gross prices.

A Johnson & Johnson employee sued the firm over allegations that the medical manufacturing giant overpaid for prescription drugs dispensed by the firm’s employee health plan — which she alleges is a violation of J&J’s fiduciary duty under the Employee Retirement Income Security Act of 1974 (ERISA). The suit is part of what some legal experts have predicted will be a “” of litigation against plan sponsors that may have paid more than they should have for certain health care services and products, potentially including prescription drugs or pharmacy benefits. The plaintiff in the suit is Ann Lewandowski, a health care policy and advocacy director at J&J, STAT reported.

PBM and drug pricing regulation will continue to be hot topics at the state level after several years of busy lawmaking, experts predict, even as PBM reforms are diluted and stalled in Congress. They predict that more states than ever will continue to embrace or pursue policies like drug affordability review boards.

“I do think the momentum is still strong, because states have the ability to do a lot more,” Kate Sikora, associate principal at Avalere Health, tells AIS Health, a division of MMIT. “Federal bills typically get a little bit watered down by the time they actually pass. So some of these state laws are a little bit heartier — a little bit more robust — in terms of what they attempt to do.”

PBM and drug pricing regulation will continue to be hot topics at the state level after several years of busy lawmaking, experts predict, even as PBM reforms are diluted and stalled in Congress. They predict that more states than ever will continue to embrace or pursue policies like drug affordability review boards.

“I do think the momentum is still strong, because states have the ability to do a lot more,” Kate Sikora, managing director at Avalere Health, tells AIS Health, a division of MMIT. “Federal bills typically get a little bit watered down by the time they actually pass. So some of these state laws are a little bit heartier — a little bit more robust — in terms of what they attempt to do.”

Last year, as the country’s three dominant PBMs faced an unprecedented amount of scrutiny, smaller firms saw an opportunity to step into the spotlight. Thus, they founded Transparency-Rx, a coalition of PBMs with “transparent” business models and a shared goal of pushing for the reform their larger rivals were resisting.

One of the members of that new coalition, SmithRx, announced on Jan. 23 that it closed a $60 million Series C financing round led by the health care venture capital firm Venrock. The latest funding infusion, which builds on a $20 million Series B round raised in 2022, positions SmithRx to continue fixing a “broken” pharmacy pricing system, according to its founder and CEO, Jake Frenz.

In a move decried by the major PBM trade group but hailed by employer plan sponsors and a pro-reform coalition of smaller PBMs, the U.S. House of Representatives on Dec. 11 passed legislation that would usher in a host of new transparency requirements for what has become a heavily criticized industry.

The Lower Costs, More Transparency Act (H.R. 5378) passed on a 320-71 vote, but an uncertain fate awaits the measure in the Senate. The bill was initially due to be voted on in September but was tabled amid concerns over lawmakers’ support and the House’s focus at the time on passing a stopgap government spending package.

In a recent report, the Pharmaceutical Care Management Association (PCMA), the trade group representing the largest PBMs, claimed that employers often choose spread pricing when they set up their PBM contracts. But employer plan sponsor groups, which have pushed for years for a federal ban on spread pricing, tell AIS Health that the way PCMA describes employers’ pharmacy benefit options is misleading — instead, the plan sponsor groups say, PBMs manipulate employers into spread pricing arrangements.

PBMs are under intense scrutiny in Congress: Legislators from both parties seem likely to pass more aggressive regulation of the industry this year. A ban on spread pricing is one of the key policies under consideration. Spread pricing is the business practice in which PBMs pay pharmacies dispensing a drug less than what they charge payers, with the PBM pocketing the difference. This can result in substantial revenue for the PBM, as the “spread” for the same pharmaceutical product can vary widely from pharmacy to pharmacy.