Medicaid
Manufacturers have supported the proposed shift in oversight authority, which could create a more pharma-friendly environment in the drug discount program, but uncertainty remains.
Coverage data from the two programs suggest Medicare beneficiaries may be more disappointed than Medicaid enrollees by the Trump Administration’s decision not to mandate the programs cover obesity drugs.
As CMS administrator, Mehmet Oz will oversee the second cycle of Medicare drug price negotiations and Part D redesign issues, but will have experienced deputies to help.
Calley Means defended reductions in force at the Health and Human Services Department that shocked and outraged federal workers and stakeholders.
A former CMS manager worries casework and other necessary functions could suffer as a result of the 300 staff cuts at the agency that are part of a massive HHS restructuring.
About 3,500 full-time FDA employees are expected to be laid off as part of a restructuring of the Health and Human Services Department and experts questioned whether the cuts could be implemented without harming FDA’s core mission.
Democrats opposed the nomination because they believe Mehmet Oz will not defend Medicaid from spending cuts. His pledge to continue lowering drug costs in Medicare and Medicaid did not offset the concerns.
US CMS Administrator nominee Mehmet Oz promises to inspire the agency he is set to lead and seems likely to succeed compared to other Trump Administration nominees.
Physician and TV personality Mehmet Oz, who is President Trump's nominee for CMS administrator, said he was instructed by President Trump to explore “every single way” the agency could lower drug costs.
Recently retired CMS veteran John Coster discussed potential Medicaid cuts, rebate cap elimination and obesity drug coverage in an interview with the Pink Sheet.
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.
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.
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.
If successful, the new CMS cell and gene therapy access model eventually could expand to oncology or hemophilia products, an Avalere Health expert said.
A Catalyst fix, a pediatric rare disease voucher reauthorization that should prevent future workload imbalances for FDA, and a boost for out-of-state coverage in Medicaid are among Congress’s year end commitments to pediatric and rare disease patients that now seem in doubt.
Scant evidence has emerged proving that carving out retail pharmacy benefit management from Medicaid managed care organization contracts helps limit costs.
The proposal states that Part D plans could define "obesity" for coverage determination, but CMS said overly restrictive criteria would be inconsistent with formulary review requirements and step-therapy would not be allowed.
Proposed rule on GLP-1s sets up an expensive benefit that would need to be implemented (or rejected) by the incoming Trump administration. Move suggests the next round of drugs subject to Medicare price-setting will include Novo’s semaglutide – and could be announced by the Biden team before they leave.
But the expected nominee brings little experience running a large government organization or with the policy and budget challenges confronting Medicare and Medicaid.