Keep Informed on Legal and Compliance Developments Affecting Diagnostic Labs
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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
FDA Watch: Agency Resounds the Alarm on Biotin Test Interference
In early November 2019, the U.S. Food and Drug Administration (FDA) updated a previous safety communication about the potential of biotin to significantly interfere with diagnostic tests. The update reiterates the warning
FDA Unveils New Process for Streamlined Review of IVD Tests Used in Cancer Drug Trials
Typically, in vitro diagnostic (IVDs) tests used in investigational cancer drug trials require two submissions: one for the IVD test and another for the drug. But on Oct. 9, 2019, the US Food and Drug Administration (FDA) issued final guidance setting out a streamlined process that allows companies to apply
Immigration alert, social media, salary threshold, minimum wage, trafficking and more
By Mike O’Brien bio
Immigration alert—more Social Security “no-match” letters to issue this fall: The Social Security Administration (SSA) has announced its plan to mail a second set of “no-match letters” to employers this fall…
Testing Trends: The Debate Continues Over Regular Colorectal Screening for Average Risk Adults
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Zika Antibody Detection Tests Go from Emergency to Commercial Clearance
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Test Utilization: ‘Cascades of Care’ Cause Wasteful, Unnecessary and Anxiety-Producing Testing
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Emerging Tests: New Genetic Tests May Be Better than PSA Screening in Assessing Prostate Cancer Risk
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New Laws: Proposed Kickback Changes Would Provide Needed Relief But Also Largely Exclude Labs
In what could be the most significant story in health care fraud and abuse compliance of the past several years, the CMS and OIG proposed new rules (the Proposal) to adapt 20th century kickback laws to 21st century market conditions,
New Product Development: FDA Issues Final Guidance on IVD Oncology Trials
On Oct. 10, 2019, the FDA finalized guidance on an optional streamlined submission process to determine whether
CMS Delays Controversial Hospital Price Transparency Rules
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