California recently passed Assembly Bill 315 to create greater regulatory oversight of pharmacy benefit managers (“PBMs”). [1] The bill requires PBMs to provide more transparency regarding their operations. PBMs will have to register with the California Department of Managed Health Care (“DMHC”) and provide new disclosures to the purchasers of their services. The bill will also establish a new pilot project and task force run by the DMHC to analyze how PBMs are affecting the pharmaceutical market.
Impact on Pharmacy Benefit Managers
The bill defines a PBM as a person or entity that enters into a contractual agreement to manage the prescription drug coverage of a health care service plan. This management includes tasks such as processing and paying claims for prescription drugs, processing drug prior authorization requests, adjudicating appeals related to prescription drug coverage, contracting with network pharmacies, and controlling the cost of covered prescription drugs. However, the bill excludes licensed health care service plans, and their employees, who perform these services from this definition.
The bill imposes a new duty on PBMs to exercise “good faith and fair dealing”. This duty is engendered by new rules that will require PBMs to reveal direct and indirect conflicts of interest, and to provide quarterly reports upon request, to the purchasers of their services, such as health care plans. The reports include eight different financial disclosures that cover information ranging from the aggregate amount of the fees imposed on network pharmacies to any administrative fees the PBMs received from pharmaceutical manufacturers.
PBMs will also have to register with the DMHC and meet new contractual standards. The contractual standards cover both new requirements and prohibitions. For instance, PBMs will be prohibited from preventing providers from informing patients of less costly alternatives for prescribed medicines. This will affect contracts that are created on or after January 1, 2019.
Impact on Pharmacies
The bill requires pharmacies to either inform customers purchasing covered drugs if the retail price is lower than their cost-sharing amount, or just automatically charge them the lower amount. If the customer ends up paying the retail price, the pharmacy must still submit the claim to the health care service plan or insurer. The payment made by the customer will apply to their deductible and maximum out-of-pocket limit. This enforcement will be required for any contract that is created on or after January 1, 2019.
New Pilot Program and Task Force
The bill also creates a new pilot project that is designed to assess how permitting enrollees to access the same quantity of prescription drugs at a retail pharmacy as they would otherwise be able to access through a mail order pharmacy will impact network pharmacies. The project will take place in the northern county of Sonoma, and the southern county of Riverside from July 1, 2020 to July 1, 2023. During that time the designated plans will be required to make annual reports to the DMHC concerning how the project is changing the cost and utilization of prescription drugs.
The bill also requires the DMHC to create a task force that will convene by July 1, 2019 and will determine reporting criteria for PBMs related to pharmaceutical costs. The reporting criteria might include data related to drug rebates, payments made to network pharmacies, exclusivity arrangements, and the wholesale cost of pharmaceuticals. The task force is to report its determinations to the State Legislature by February 1, 2020.
*John Tilton is a Law Clerk in Sheppard Mullin's Century City office.
[1] The bill is available at: https://leginfo.legislature.ca.gov/faces/billTextClient.xhtml?bill_id=201720180AB315.