STAT+: CBO says revised cost of orphan drug exemptions will add $3.9 billion to Medicare

The Congressional Budget Office has revised its forecast showing the recently enacted One Big Beautiful Bill Act will cost taxpayers as much as $8.8 billion — up from earlier estimates of $4.9 billion — over 10 years thanks to provisions that will exempt or delay certain drugs from Medicare pricing negotiations.

The update, which was attributed to the added expense of exempting three drugs for which Medicare has spent great sums of money, was quickly seized upon by patient advocates and three leading congressional Democrats as evidence of a “sweetheart” deal that the White House and Republican lawmakers made with the pharmaceutical industry at the expense of seniors.

Here’s why: Initially, the Inflation Reduction Act, which went into effect three years ago, allowed Medicare to negotiate prices, but exempted orphan drugs, which are used to treat rare diseases. Specifically, the exemption extended to a drug with just one orphan designation that was granted and approved by the Food and Drug Administration.

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