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”
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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
USPSTF Recommends Hepatitis C Virus Infection Screening for All Adults
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FDA Finalizes CLIA Waiver Guidance for Approval of New In Vitro Diagnostic Devices
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Billing & Coding: CMS Sets Rules for Medicare Coronavirus Testing Reimbursement with Private Payors Expected to Follow Suit
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Reimbursement: Congress Calls on Insurers to Cover Coronavirus Testing without Charging Patients
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Free G2 Report COVID-19PANDEMIC: The Lab Industry Response & How to Protect Your Employees
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Why Cleaning Up Your Dirty Data is Critical to Clinical Interoperability and Financial Survival
By Gregg Church bio
Hospital-based and commercial labs are flooded with all types of mismatched patient data. However, disparate systems coupled with a lack of universally mandated data standards and protocols means that big data just gets bigger—and clinical interoperability challenges just get larger…
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…
Compliance Perspectives: Using Document Management Systems to Avoid HIPAA Pitfalls
By Andreas Rivera bio
Record-keeping can be one of the most stressful aspects of running a healthcare business since privacy compliance is scrutinized in healthcare more than any other industry.
Anyone with experience in the healthcare industry knows that violating HIPAA comes with steep penalties…
LDTs: FDA Gets Tough with Non-Approved PGx Testing Claims
From - National Intelligence Report
The FDA has apparently set its enforcement sights on Laboratory Developed Tests (LDTs) that claim to predict…