February 05, 2019
On January 31, 2019, the Department of Health and Human Services (HHS) released a proposed rule (seen here) which would amend the safe harbor regulation concerning rebates between drug manufacturers, insurers, and pharmacy benefits managers (PBMs) (third-party administrators of a prescription drug program). The proposal, which applies to federal healthcare programs, is designed to reduce out-of-pocket spending on prescription drugs by encouraging manufacturers to pass rebates directly on to patients at the point of sale (instead of the PBMs), hopefully resulting in lower prescription drug prices to consumers.
If implemented, the proposed rule will take effect on January 1, 2020.
Generally, a drug manufacturer pays a rebate, or discount, to a PBM, in order to gain favorable status for their drugs versus others on the list approved for reimbursement. Existing regulations contain a safe harbor that protects this practice from liability under Section 1128(b) of the Social Security Act, the federal anti-kickback statute.
This proposed rule would amend the current safe harbor regulation to eliminate the protection status for those discounts offered by prescription drug manufacturers to plan sponsors under Medicare Part D, Medicaid managed care organizations, or PBMs under contract with them. In addition, new safe harbors are being proposed to protect certain point-of-sale reductions on prescription drug products and PBM service fees.
The proposed rule would apply directly to those purchasing prescription drugs under Medicare drug plans and Medicaid managed-care plans. Employers would not be affected by this current executive order for their traditional employer health plan. However, if implemented, this rule may incentivize Congress to take further action to halt the rise in pharmaceutical costs- including the potential to enact legislation to prohibit rebates in commercial insurance. Furthermore, private insurers typically use government programs as a gauge for taking action, and this may be no exception.
According to Kaiser Health News , there may be both winners and losers as a result of ending drug rebates. Possible winners include chronically ill patients who take lots of expensive medicine, as well as the drug manufacturers themselves (who will not be impacted by a drop in profits as a result). It is also hopeful that eliminating the rebates would slow down the steep rate of list-price increases that have been occurring lately. Losers potentially include PBMs and insurance companies, as well as patients without chronic conditions and high drug costs, who could see insurance costs increase without getting the benefits of lower out-of-pocket expense for purchased drugs.
PBMs play an important role in the administration of outpatient prescription drugs, and this proposed regulation does not mean they will be going away anytime soon. With the increase in rebates, especially over the past 3 years, many employers have enjoyed lower Rx costs in their health plans. The elimination of these rebates could provide some short term cost increases until the pricing of drugs are adjusted for a new non-rebate environment. This adjustment would take time.
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