CMS ex­plains how it will ne­go­ti­ate the most ex­pen­sive drug prices with bio­phar­ma be­gin­ning in 2026

The Cen­ters for Medicare and Med­ic­aid Ser­vices (CMS) late Wednes­day pub­lished its first long-await­ed guid­ance on how ex­act­ly bio­phar­ma com­pa­nies will have to ne­go­ti­ate with the fed­er­al gov­ern­ment when it comes to the most ex­pen­sive of drugs, be­gin­ning in 2026.

The 91-page guid­ance doc­u­ment sets the re­quire­ments for man­u­fac­tur­ers of Medicare Part D and B drugs that are se­lect­ed for ne­go­ti­a­tions, and CMS is so­lic­it­ing feed­back, be­fore April 14, on every­thing from the ini­tial of­fer and coun­terof­fer ex­changes be­tween CMS and man­u­fac­tur­ers, how the max­i­mum fair price (i.e. the ne­go­ti­at­ed price) will be ap­plied across dif­fer­ent dosage forms and strengths of a drug cho­sen for ne­go­ti­a­tions, as well as the process for is­su­ing mon­e­tary penal­ties to those vi­o­lat­ing the new law.

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