An on-site pharmacy at an employer’s facility or at a hospital, which usually is the preferred pharmacy for that employer or organization.

A pharmacy that is either stand-alone or part of a group of two or three pharmacies that are pharmacist-owned, privately held businesses.

The IRA, enacted in 2022, made several changes to Medicare, including the following changes affecting drug pricing:

Medicare Drug Price Negotiations: The IRA authorized Medicare Part D to negotiate prices for covered drugs. Negotiations are underway as of 2024 between CMS and manufacturers of the first 10 drugs selected; prices are expected to be finalized so that they can be in effect under Part D in 2026. Negotiated drugs must be covered in Part D, but plans are not prohibited from putting them on non-preferred formulary tiers or imposing prior authorization of step therapy restrictions .

Medicare Part D Redesign: The IRA made several changes to the Part D drug benefit, which generally require Part D plans and manufacturers to pay a greater share of costs for enrollees with high drug costs, including:

• As of 2024, once enrollees hit the catastrophic phase (which is set at $8,000), they no longer have to pay the 5% coinsurance.


• As of 2025, there will be an annual $2,000 cap on enrollee out-of-pocket (OOP) drug spending.


• As of 2025, Part D plan sponsors and manufacturers will pay a larger share of costs for catastrophic coverage, and Medicare will pay a smaller


• Other changes include limits on increases to the base beneficiary premium, establishment of insulin copay caps, and a new option for enrollees to spread out their OOP costs over the year rather than face high OOP costs in a given month .

A pharmacy benefit that is developed and administered by the health plan sponsor as part of its overall health care benefits offering.

An interchangeable biological product is a biosimilar that meets additional study requirements and may be substituted for the brand reference product at the pharmacy, depending on state pharmacy laws. Interchangeable biological products (also called interchangeable biosimilars or interchangeable products) may help increase patient access to biologics.

The IND is an application that exempts a drug that is in development from current federal law requirements on transportation or distribution across state, thus permitting testing of its diagnostic or therapeutic potential in humans through clinical trials.