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
- Updates on changes to regulations
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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
Labs in Court Weekly Roundup
False and fraudulent claims and billing were the theme in key enforcement actions relating to the health care industry announced last week.
FDA Reorganizes Its Center for Devices and Radiological Health
The changes affect the Office of Product Evaluation and Quality’s Office of In Vitro Diagnostics and Radiological Health.
Get Ready for G2’s New Website
By the end of this month, G2 Intelligence’s website will have a new look and feel, plus simplified site navigation.
Physician Practices See Strong Q1 2022, but Challenges Remain
Recent report shows physician revenues, compensation, and productivity rose in the first quarter of 2022, but so did subsidies and expenses.
New EU IV Diagnostic Regulation Set to Roll Out
The IVDR will bring around 80 percent of in vitro diagnostic medical devices under the control of so-called Notified Bodies.
New EU IV Diagnostic Regulation Takes Effect on May 26
While the much-delayed IVDR will take effect at the end of the month, it will be rolled out gradually.
Many Medical Device Companies Are Not Ready for Cyberattacks
According to a recent survey of product security experts, despite many saying their companies are ready for hacks, data show otherwise.
Watch Out for Fake COVID-19 Tests, FDA Warns
Agency warns the public to be on the lookout as counterfeit at-home OTC COVID-19 diagnostic tests appear on the US market.
OIG: Medicare Advantage Plans Are Stiffing Physicians on Reimbursement
New report shows a fair portion of prior authorization and physician reimbursement request denials actually met Medicare coverage rules.
Precision Oncology Company Nabs Coverage for Advanced Cancer Test
In this month’s Business Roundup, we cover key happenings including Medicare coverage and reimbursement, as well as the US surpassing Europe as medtech’s market of choice.
