The Federal Trade Commission is launching an inquiry into the pharmacy benefit manager industry and requiring the six largest PBMs to provide information and records regarding their business practices.
The inquiry will look at the effect of vertically integrated PBMs on access and affordability of prescription drugs through compulsory orders to CVS Caremark, Express Scripts, OptumRx, Humana, Prime Therapeutics and MedImpact Healthcare Systems, according to a June 7 news release.
The companies will have 90 days from the date they receive the order to respond.
"Although many people have never heard of pharmacy benefit managers, these powerful middlemen have enormous influence over the U.S. prescription drug system," FTC Chair Lina Khan said. "This study will shine a light on these companies' practices and their impact on pharmacies, payers, doctors and patients."
Specifically, the inquiry will analyze:
- Fees and clawbacks charged to unaffiliated pharmacies
- Methods used to direct patients toward PBM-owned pharmacies
- Potentially unfair audits of independent pharmacies
- Complicated and unclear methods to determine pharmacy reimbursement
- Prevalence of prior authorizations and other administrative restrictions
- Use of specialty drug lists and policies
- Impact of rebates and fees from drug manufacturers on formulary design and costs of prescription drugs to payers and patients
In February, the agency issued a request for comment about how PBM practices affect patients, physicians, employers and pharmacies. Comments were due April 25, and 24,000 were collected.
On May 24, bipartisan legislation was introduced in the Senate that would allow the FTC to increase drug pricing transparency and suppress pharmacy benefit manager practices such as spread pricing and payment clawbacks.
Over the last year, over a dozen state legislatures have proposed or passed legislation also aimed at increasing regulations around the PBM industry.