FDA Watch: New Guidance on Charging for Investigational Drugs
On August 21, the FDA proposed new guidelines on charging for investigational drugs; here are the key highlights.
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Final Surprise Billing Rules Seek to Provide Fairer Price Dispute Resolution
Revised final rule essentially disarms the threat of insurers having the advantage in out-of-network price disputes.
Labcorp Continues Its Outreach Labs Buying Spree
While the overall M&A market has been slow in 2022, Labcorp has been on a bit of an acquisitions binge.
Amazon Ends Telehealth Services, but Forges Ahead with Healthcare Disruption
In a surprise move, the e-retail giant announced it will close down its Amazon Care Primary Health Services for employees at the end of 2022.
CMS Proposes Significant Increases to CLIA Fees
While the rule is not yet final, it’s likely that labs will have to pay more in direct CLIA compliance expenses, starting in October.
FY 2022 Q2 Earnings Trend Down, but Much Less than Predicted
While not nearly as robust as a year ago, diagnostic companies’ revenues held up surprisingly well in Q2 2022.
FDA Re-Opens Pre-Submission Requests for Non-COVID-19 IVD Tests
The agency is once more accepting pre-submissions for all in vitro diagnostic tests, not just those for COVID-19.
Quest and Color Health Join CDC to Promote Equitable COVID-19 Testing
In July, ICATT took a major step toward equitable access to testing by enlisting two of the country’s leading COVID-19 PCR test providers.
Fate of Illumina’s Grail Acquisition Remains Very Much in Doubt
It’s beginning to look like Illumina’s roll of the dice is going to come up snake eyes regarding the potential acquisition.
Surprise Billing Rules Would Give Private Health Plans Advantage in Disputes
The way the No Surprises Act is implemented would essentially allow private health plans to set out-of-network rates in billing disputes.
FDA to Continue Remote Regulatory Assessments after Pandemic Ends
Meant to be temporary, remote regulatory assessments proved so successful that the agency will not only continue, but expand their use.
COVID-19 Test Profits Make Labs Potential Target for Public Backlash
Independent labs accrued a profit of at least $10 on each PCR COVID-19 test performed in the period from May to December 2020, study says.
Becton Dickinson, Cepheid Unveil Monkeypox PCR Test Collaborations
Some of the lab industry’s biggest players are teaming up to develop new monkeypox diagnostics in response to the current outbreak.
