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Senate Finance Draft Aims To Change Hospital, GPO Drug Procurement

The Senate Finance Committee released a draft bill that would create a new program within Medicare aimed at incentivizing hospitals, group purchasing organizations (GPOs) and other drug supply chain stakeholders to help create stable pricing for generic drug manufacturers by rewarding quality, reliability and long-term sustainable contracts.

LDT News

FDA Guide Lays Out LDT Enforcement Discretion For Public Health Threats

In light of its new rule asserting regulatory authority over laboratory-developed tests, FDA will continue to exercise enforcement discretion for some tests during public health emergencies (PHEs) and for emergent public health threats, the agency says, depending on public health needs, especially if unauthorized tests are the only options available to diagnose an emerging disease.

FDA Adds Significant Enforcement Discretion ‘Carve Outs’ In Final LDT Rule

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Health insurers can use an invalidated methodology to calculate the qualifying payment amounts (QPAs), or median in-network rates, that are integral to the No Surprises Act’s patient cost-sharing requirements -- and its independent dispute resolution (IDR) process -- for an additional six months, CMS announced this week.

Republicans raised concerns about any research collaboration between the United States and China at a House hearing this week, arguing work with scientists from China is inherently problematic, but a health researcher defended the work as necessary to guard against future pandemics.

Experts say the new center set up by FDA drug officials to boost clinical trial innovation has the potential to increase diverse enrollment in trials, and they hope the new initiative will end up encouraging decentralized trials, including greater use of wearable apps, and community-based approaches to recruitment.

Another health official from the Biden administration has expressed interest in incentivizing states to conduct more Medicaid audits -- an idea floated by a key Republican on the House Energy & Commerce Committee as part of broader congressional efforts to crack down on fraud and waste in public health insurance programs.