New rules announced today by the FDA will make it harder for pharmacy benefit managers (PBMs) to buy and sell prescription drugs.PBMs are an essential part of the health care system because they make up 80% of all pharmacy sales.
However, they can be slow to get reimbursed for prescription drugs that are expensive to fill.
The new rules, which are scheduled to go into effect in 2019, are designed to give PBMs greater oversight over the amount of reimbursement they get for drugs purchased through their own pharmacies.
This is part of a broader effort to rein in prescription drug costs.
Last year, President Trump directed the FDA to study whether PBMs should be allowed to sell prescriptions for drugs that cost a little more than $100,000 a year, or if they should be able to buy generic drugs for $100 a bottle.
The agency was considering whether the rules would also apply to the cost of some generic drugs, but the Department of Health and Human Services (HHS) said that would be a separate study.
The proposed rules also require PBMs to obtain written authorization from pharmacies before they can sell drugs on their websites, and they have to post a warning about the cost to patients if they do.
The FDA said that in many cases, PBMs are already required to have the same authorization and have the option to purchase and sell drugs from the same pharmacy.
The rules also create a new incentive for PBMs and other health care providers to help pharmacies sell drugs.PBMs can be charged $5 for each prescription they sell, and the fee goes directly to the drug benefit manager, not the pharmacy.
This would require them to sell drugs in bulk or sell drugs at low price points.PBSM’s have long been allowed to negotiate the price for drugs they sell through their websites.
Under the proposed rules, they would also have to offer to buy from other PBMs instead.
However, this would also mean that PBMs would be able sell drugs directly from their own websites without having to provide their own authorization.PBM representatives have argued that the FDA’s proposed rules could hurt their ability to negotiate lower prices.
They have also argued that these new rules will make PBMs more competitive with other health insurance plans, like Blue Cross Blue Shield, that offer insurance to both PBMs as well as private insurers.PBMA’s say that the new rules would not impact the way that their own PBMs sell drugs, and would instead only limit the ability of PBMs who want to negotiate prices with PBMs.
They argue that this could result in PBMs having to purchase more generic drugs and that PBM’s will also need to pay more for prescriptions.
According to a statement by the American Pharmacists Association, PBMA representatives said:The new rule will require PBM members to submit written authorization to PBMs before they are allowed to purchase or sell a generic drug from a participating pharmacy.
If a PBM member has not received written authorization, it is unclear how PBM membership will be impacted by the rule.
The changes are expected to affect a handful of PBM companies, such as Rite Aid, which has more than 2,500 pharmacies in the United States.
They include Walgreens, which owns more than 8,000 pharmacies in 25 states and the District of Columbia.
The Associated Press contributed to this report.