By Jimmy Jackson, senior VP and chief policy officer, Biocom

Some of the most significant FDA drug approvals of the past 12 months have come in oncology, with many therapies meaningfully improving survival rates for patients. Yet this progress now faces a serious threat: federal policy that could curb future breakthroughs.

The Center for Medicare and Medicaid Innovation (CMMI) has proposed a “most-favored nation” (MFN) pricing model, GLOBE, which would require manufacturers to pay a rebate on certain Medicare Part B drugs administered in a clinical setting. Oncology therapies are among the most commonly prescribed Part B drugs and biologics. Therefore, the effects of GLOBE would be widespread and disproportionately affect small and mid-sized companies, including those without an approved product. CMMI has proposed an equivalent MFN model, GUARD, for certain Medicare Part D drugs. Biocom has prepared an FAQ on GLOBE and GUARD for members.

In practice, CMS would require manufacturers to pay a rebate whenever the U.S. Medicare price for a covered drug exceeds the international benchmark price. The rebate would apply only to specified drugs used by beneficiaries in randomly selected geographic regions—representing 25% of Part B beneficiaries and 25% of Part D enrollees.

Review Biocom’s comment letters on these proposals here and here.

If the proposed models are finalized, Biocom will consider legal remedies on behalf of our members to challenge the Trump Administration’s new CMMI GUARD and GLOBE models, which would impose far-reaching “most-favored-nation” pricing requirements on certain Medicare Part D and Part B products, respectively. Companies who may be interested in joining this effort are asked to contact Laure Clark in Biocom’s Washington, D.C. office.

Biocom will keep tracking both rules through finalization and will update members as CMS’s plans become clear.