The White House’s Office of Information and Regulatory Affairs (OIRA) has signed off on FDA’s final rule for regulation of laboratory-developed tests (LDTs), indicating that the controversial, much-anticipated rule could be available at any time.
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FDA’s latest per- and polyfluoroalkyl substances (PFAS) test found the chemicals present in eight of the 95 food samples tested in a regional collection from the agency’s Total Diet Study (TDS).
Vice President Kamala Harris on Monday morning (April 22) announced CMS’ nursing home final staffing minimums and a sweeping long-term care worker rule stemming from the Biden administration’s April 2023 executive order on the direct care workforce.
The White House’s Office of Information and Regulatory Affairs (OIRA) has signed off on FDA’s final rule for regulation of laboratory-developed tests (LDTs), indicating that the controversial, much-anticipated rule could be available at any time.
The White House is releasing a new National Strategy for Suicide Prevention, updating the federal approach to the issue for the first time in more than a decade and launching a federal action plan with more 200 steps that the Biden administration hopes to take over the next three years, emphasizing priorities like health equity.
While the leading lobbying group for pharmacy benefit managers (PBMs) highlights the role of PBMs in rural pharmacy access, pharmacists’ groups remain steadfast in urging Congress to pass comprehensive legislation that would prohibit PBMs from engaging in business practices they say lead to higher prescription drug costs for patients and payers and pose a threat to the sustainability and operations of independent community pharmacies.
The Biden administration is keeping itself busy this week with lawmakers out of town, releasing Monday (April 22) its long-awaited rule instituting the nation’s first minimum staffing standards for skilled nursing homes, requiring facilities receiving Medicaid/Medicare reimbursement to have a registered nurse onsite 24/7and other requirements. HHS also unveiled the final “Ensuring Access To Medicaid Services” rule that aims to boost access to home care and to quality jobs in the sector by mandating at least 80% of Medicaid pay for home services goes toward workers’ wages.
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House Budget Chair Jodey Arrington (R-TX) during a Rules Committee markup Thursday (April 18) floated enacting site neutral payments in Medicare to pay for the $95 billion national security supplemental bill and reduce the deficit by an additional $50 billion. |
Women’s rights advocates, providers and other stakeholders are raising concerns that the consolidated pair of impending Supreme Court cases up for oral arguments Wednesday (April 24) could have dire consequences for emergency medical protections and access to stabilizing treatment. |
House Republicans appeared reluctant during a hearing this week to agree to any funding increase for FDA, despite the leading FDA stakeholder organization urging Congress for a fiscal 2025 funding amount $214 million above what President Joe Biden’s funding request asks for. |
A report co-sponsored by FDA suggests many clinical trial sponsors want the agency’s help on how to comply with the reporting requirements for HHS’ clinical trials database, Clinicaltrials.gov -- a database suffering from significant gaps and over which FDA has enforcement responsibility. |
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