PhRMA slams proposed change to Medicaid line-extension definition

In  comments recently submitted to the administration, trade group Pharmaceutical Research and Manufactures of America (PhRMA) raised concerns with a number of changes included in the Centers for Medicare & Medicaid Services (CMS) Medicaid proposed rule.

Writing on the PhRMA website, Nicole Longo, director of public affairs focusing on Medicare, 340B, importation and more, says we’re diving deeper into CMS’s proposal to vastly expand the types of medicines that would fall under the definition of a “line extension” and how that change threatens future development of needed cures and treatments by establishing a tax on innovation.

To provide some context, the proposed change builds on a concept initially introduced by Congress in the Affordable Care Act, which created a higher Medicaid rebate for “line extensions” of medicines – meaning slight changes to a medicine, such as a tablet’s color or shape, that were viewed as not providing any meaningful difference for patients. The CMS’ proposed change to the line extension definition under the rule, however, would extend well beyond Congress’s original intent. In general, it would broaden the definition of a “line extension” to include any change to a “parent” medicine, where the “child” medicine contains at least one active ingredient in common with the parent medicine.