April 18, 2023
Life Sciences | Tea Leaves
  • The industry lobby group PhRMA made a list of complaints to the Centers for Medicare and Medicaid Services (CMS) about Medicare’s new drug price negotiation program, including complaints of only allowing for a 30-day comment period on guidance, limited meetings between the agency and manufacturers during the price-setting process, and gag clauses on manufacturers during negotiations, among other criticisms. The group said that the program is in “no way a ‘negotiation,'” adding that CMS “chose to go beyond what was outlined in the statute, taking the most extreme stance to sweep in as many medicines as possible and be as punitive as possible.” CMS’ Medicare Drug Price Negotiation Program will kick off in 2026 with “maximum fair prices” for up to 10 Part D drugs with no generic or biosimilar competition, according to initial guidance for the program released by the agency Wednesday. The release was accompanied by a call for public comment on the initial guidance, and CMS will consider comments received by April 14 for the release of its revised guidance, which it “anticipates” issuing for the 2026 negotiations sometime this summer. (Article here)