BIO, PhRMA comment on Medicare drug rule

The Biotechnology Industry Organization urged the Centers for Medicare & Medicaid Services to modify its proposed rule that would implement the Medicare Part D prescription drug benefit. The benefit is slated to come into effect in 2006. In comments submitted Monday, BIO asked CMS to expand the model formulary guidelines crafted by the US Pharmacopoeia (USP) and to establish separate formulary standards for rare diseases. BIO also expressed concern about CMS's proposal to require that physicians document off-label uses of drugs and biologics. ...