Medicaid
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.
The FDA’s Peter Marks warned novel approvals will suffer if the agency is forced to spend its time relitigating vaccines. At the top HHS post Kennedy could impact pharma from basic research funding to drug pricing.
The US Medicaid agency will not require diagnostic codes on prescriptions any time soon after hearing “overwhelming” opposition from stakeholders.
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.’
The move is positive for manufacturers and follows the agency’s decision to drop another contentious proposal that would have ‘stacked’ drug discounts when calculating Medicaid best prices.
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.
Vertex’s fertility preservation assistance program would provide up to $70,000 in financial support for in vitro fertilization and other services to patients prescribed Casgevy.
The agency says it will collect additional information from manufacturers on methods for adding up price concessions from the supply chain before moving ahead.
The authorized generic also could mitigate the impact of eliminating the cap on Medicaid price inflation rebates, which went into effect in January.
Sandoz argued against paying higher rebates for two of its drugs via the Centers for Medicare and Medicaid Services’ Medicaid drug rebate program in a US court six years after the suggestion was first made.
Various government and private payer initiatives are good steps forward, but lack coordination. Payers continue to face perverse incentives to use high-cost drugs because of rebates in 340B, while providers don’t have enough incentives to use cost-saving clinical decision tools.