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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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Public Citizen Hits Eli Lilly For Not Disclosing Lobbying Expenses Ahead Of Shareholder Vote

As a handful of key Senate Democrats and consumer advocates engage in a broader effort to get companies to disclose lobbying expenses, Public Citizen on Friday (May 3) blasted drug maker Eli Lilly for not making all its expenditures public in the run-up to its annual meeting next week where shareholders are slated to hold a vote demanding transparency.

Cassidy Calls For More Bird Flu Transparency From FDA, Administration

The ranking Republican on the Senate health committee, Sen. Bill Cassidy (LA), is asking the Biden administration to provide more transparency on its gathering of scientific evidence surrounding the current outbreak of avian influenza, including information about the testing FDA is doing to measure the safety of the milk supply.

CMS Extends Enforcement Discretion For No Surprises Act QPA Calculations

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.

GOP Skeptical Of Research Collaboration With China, NIH Oversight

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.