Medicare

The pharmaceutical industry has been quiet on Trump's early federal government overhauls that could harm the drug business, still betting he will help produce better results than Biden.

The "interwoven" nature of the offices within the agency likely means Medicare and Medicaid benefits may be disrupted by staff cuts despite assurances from the administration, Brooks-LaSure warned.

Congress may be empowered to change the Part D stabilization demo, but a health policy expert said CMS is more likely to repeal, adjust or replace the program.

Several first-term Trump veterans are returning to leadership roles at the US Centers for Medicare and Medicaid Services ahead of the expected confirmation of Mehmet Oz to lead the agency.

AbbVie, J&J, Merck and Pfizer discussed recent projections for the redesign's impact.

Manufacturers will address what constitutes appropriate therapeutic alternatives for the selected drugs as part of the negotiation process.

HHS Secretary nominee Robert F. Kennedy Jr. discussed the Trump Administration's support for Medicare price negotiation during his confirmation hearing.

Pink Sheet reporter and editors discuss the uncertainty created by the Trump Administration freezing most communications at the Health and Human Services Department, new travel and telework bans, as well as the delay in announcing an acting FDA leader and the impact of new executive orders on the FDA and CMS.

Since CMMI does not need an executive order to conduct demonstrations, President Trump's executive order does not appear to mean the models developed under the Biden Administration will be suspended, yet.

Speculation that the Trump Administration may "pause" the second negotiation cycle to make changes to the program adds uncertainty to an already challenging scenario.

Stelara, Xarelto, Januvia and Farxiga, which are expected to have biosimilar or generic competition before the end of 2026, could be the first negotiated drugs subject to the policy.

Anti-PBM sentiment continues to rise, but industry observers still question whether the reforms being discussed will be effective.

Any Trump Administration policy involving international pricing should include foreign governments paying higher prices, as well as lowering US prices, CEOs say.

A TD Cowen survey explored expectations about the impact of the Inflation Reduction Act, access to 340B discounts and general price trends.

Data illustrates the 2025 Medicare Part D plan landscape, including changes in premiums and plan options.

Despite GOP criticism of the Part D stabilization program and its budgetary impact, the Trump Administration may decide to keep it in part to avoid blame for a premium increase.

If successful, the new CMS cell and gene therapy access model eventually could expand to oncology or hemophilia products, an Avalere Health expert said.

The much-anticipated report from the US Centers for Medicare and Medicaid Services is heavily redacted and lacks a specific justification for the prices, but preserves agency flexibility to shape the program going forward.

In the proposed rule, CMS said it would begin reviewing Part D plan formularies and utilization practices to see if programs include incentives to reduce costs, as well as offered suggestions for implementing the new Medicare Prescription Payment Plan.

The new discount obligation will more than offset the increased sales expected to be driven by the redesign's $2,000 cap on beneficiary spending. The forecast is the first public discussion of the Part D redesign's impact on an individual company.