Medicare

A growing number of future Part B candidates for Medicare price negotiation may avoid price controls in the program with injectable versions.

But the prospects for attaching the legislation to a federal spending package in December will be dependent on the outcome of the upcoming elections.

The proposed CMS innovation center's $2 drug list model will not address the barriers to newer generics getting on Part D formularies and plans may have little incentive to participate in the demo, an industry group said. 

Policy experts and consultants recount their experiences shepherding manufacturers through the first round of Medicare price negotiations during a recent webinar.

Prior authorization reforms could emerge as an important under-the-radar area of drug policy next year. An upcoming Medicare proposed rule, the extraordinary uptake of weight loss therapies, and the launch of the overhauled Part D benefit design will all drive attention to the issue.

HRSA threatens nuclear option and Johnson & Johnson suspends its 340B rebate model. But the company also ‘reserves all of its legal rights with respect to this matter.’

Instead of $5bn in 2025, the redesign could cost the federal government two to four times that amount, the Congressional Budget Office told Republican lawmakers. And the Part D premium stabilization demonstration will cost an additional $7bn, the office projected.

The final Medicare price negotiation guidance for the next cycle includes improvements from last year’s patient listening sessions.

Manufacturers ‘strongly object’ to the possibility floated by the Centers for Medicare and Medicaid Services that it could extend price inflation rebates to Part B drugs furnished to enrollees in Medicare Advantage plans in addition to those covered by fee-for-service Medicare.

New terms for Medicare Part D beneficiaries interested in enrolling in Pfizer’s oncology patient assistance program in 2025 involve attestations that assistance is still needed after enrolling in the new M3P program and that they have not yet met the $2,000 out-of-pocket spending cap.

The US Medicare agency is encouraging use of observational trials to fulfill Coverage With Evidence Development requirements, but details will await an upcoming guidance on “fit for purpose” studies.

Medicare coverage with evidence development final guidance includes few substantive changes from the proposed version despite biopharma stakeholder concerns.

Congressional Budget Office responses to questions from US lawmakers on pharmacy benefit managers could add to the momentum for PBM reforms to go further than the current leading proposals.

Pink Sheet reporter and editors discuss the take-aways from the landmark first Medicare negotiated drug prices and what additional information remains outstanding.

But the amount of savings realized when the Medicare negotiated prices go into effect in 2026 remains the subject of debate.

CBO estimated Medicare would get 50% net price reductions under the IRA, but CMS actually garnered 22%. The CBO analysis could not account for some of the particulars of the negotiations, but some health policy experts stressed any net gain over private Part D plan negotiation is a win.

Some manufacturers may have the dubious distinction of being targeted in the first and second rounds of the negotiation program, but at least will be familiar with the process the next time.

Net per drug savings achieved by the negotiation process is unclear because many of the products already have significant rebates. The announcement also leaves much of the agency’s negotiation process in the dark.

The CMS supplemental reimbursement for the gene therapies is higher than usual for new technologies, but is similar to the formula used for antibiotics.

The analysis was released days before the Biden Administration is expected to announce a reduced Medicare Part D price for Johnson & Johnson’s immunosuppressant resulting from the government negotiation program established by the Inflation Reduction Act.