Keep Informed on Legal and Compliance Developments Affecting Diagnostic Labs
Best practices and expert insight to help lab professionals comply with regulations and identify strategic trends in business and technology
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Lab Industry Advisor Subscriptions Include
Analysis and insight on key compliance, legal, and business developments affecting laboratories
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Latest Articles
LDTs Rule Update: More Support for Legal Challenges Against FDA
Key clinical laboratory organizations file amicus brief, reiterating that the FDA is overstepping its authority, and its new rule would cause “irreparable patient harm”
New FDA LDTs Guidance Offers Useful Summary, But Questions Remain
Recently released document for small labs offers a more digestible version of the final rule requirements but still lacks key details
CMS Slated to Close Change Healthcare Payment Program
Program meant to ease cash flow disruptions experienced by some Medicare providers and suppliers due to the cyberattack will conclude in mid-July
Sweeping New FTC Rules Could Chill Healthcare Mergers and Acquisitions
Proposed rule would require businesses to undergo even more stringent review to secure regulatory approval for such deals.
OIG Sheds Light on Kickback Implications of Online Healthcare Directories
Recent advisory opinion offers insight on how healthcare providers may want to structure arrangements involving online directories.
What Are the Latest CFTR Carrier Screening Recommendations?
New ACMG recommendations aim to make CFTR carrier detection more equitable among a wider range of ancestries.
Diagnostic Error: What Harm Can It Do?
Research reveals that diagnostic error in the US may cause up to 800,000 serious outcomes annually.
The Diagnostics Pipeline: FDA Proceeds without Congress Over LDTs Reform
The agency recently sent its own proposed LDTs regulation rule to the White House Office of Information and Regulatory Affairs for review.
Enforcement Trends: OIG Calls Out CMS for Not Preventing Medicare Genetic Testing Overpayments
Inadequate CMS oversight resulted in $888.2 million in improper payments for the highest reimbursing molecular pathology genetic tests, report says.
Medicare Reimbursement: CMS Proposes to Cut Part B Payments to Physicians
The proposed PFS rule also includes other changes that will affect physician, lab, and other reimbursements in 2024 and beyond.
New CMS TCET Rule Likely Won’t Hasten Medicare Coverage of Breakthrough Devices
Recently proposed rule seems too stringent to reduce the lag between FDA approval and Medicare coverage.
2023 Lab Industry Layoffs: Where Do Things Stand?
An overview of the layoffs announced by major lab diagnostic companies in the first half of 2023 and the key trends.
Expert Discusses Key Developments in Breath Biopsy
Owlstone Medical CEO discusses recent trends, the advantages of breath testing, and the challenges that must be met for wider clinical use.
