TAG:
genetic testing
Labs May Be Excluded from Revised Stark, AKS Rules
CEO SUMMARY: When CMS and the OIG issued proposed rules last fall to make it easier for providers to participate in value-based and coordinated care arrangements, they considered excluding clinical labs, pharma companies, and DME firms because of concerns that the proposed rules could pro…
Labs May Be Excluded from Revised Stark Law, AKS Rules
This is an excerpt of a 1,460-word article in the Jan. 6, 2020 issue of THE DARK REPORT (TDR). The full article is available to members of The Dark Intelligence Group. CEO SUMMARY: Here are early insights about a federal compliance reform that has not gotten much attention among clinical la…
Lab Benefit Managers Want to Help Health Plans
CEO SUMMARY: Laboratory benefit management companies that offer a range of services to health insurers are gaining influence over clinical lab testing in important ways. On behalf of health insurers, LBMs will select labs for a payer’s network, then manage that network. They also manage…
2019’s Top 10 Lab Stories Reveal Major Laboratory Industry Trends
This is an excerpt of a 3,163-word article in the Dec. 16, 2019 issue of THE DARK REPORT (TDR). The full article is available to members of The Dark Intelligence Group. CEO SUMMARY: There was plenty of bad news in 2019 for clinical labs and pathology groups. Yet lurking inside this new…
How Labs Can Add Value for Providers, Insurers, Pharma
CEO SUMMARY: For pathologists and clinical, molecular, and genetic testing labs, appropriate reuses of lab data can provide a new source of revenue. Labs that serve as preferred providers of diagnostic testing data can help health systems, ordering physicians, pharmaceutical companies, an…
Medicare Affiliation Rule Targets Criminal Behavior
CEO SUMMARY: Under a new federal rule in effect this month, all healthcare providers—including clinical laboratories and pathology groups—will need to scour the records of all officers, directors, and affiliates to identify any that have had negative dealings with CMS or other federal…
DOJ Charges 35 Individuals In Genetic Testing Scam
CEO SUMMARY: Federal prosecutors said those charged illegally lured elderly patients nationwide into giving cheek swabs for fraudulent genetic tests. The indicted individuals allegedly paid kickbacks and bribes to medical professionals working with telemedicine companies in exchange for r…
Are Feds Now More Serious about Prosecuting Fraud?
IS IT A COINCIDENCE THAT, IN THIS ISSUE OF THE DARK REPORT, we cover two related developments, both involving the federal government’s efforts to control healthcare fraud and abuse? First, you’ll read about the new federal rule scheduled to take effect on Nov. 4. It gives federal healthcare inve…
PGx Testing Labs Concerned by FDA’s Statements, Actions
This is a synopsis of two in-depth articles in the Sept. 3, 2019 issue of THE DARK REPORT (TDR). The full articles are available to members of The Dark Intelligence Group. CEO SUMMARY: Since April, 2019, the federal Food and Drug Administration (FDA) ha…
PGx Labs Concerned by FDA’s Statements, Actions
CEO SUMMARY: Since April, the federal Food and Drug Administration has taken steps that target clinical laboratories that perform pharmacogenetic (PGx) tests. In response to letters from the FDA, some PGx lab companies have stopped reporting data that predicts a patient’s response to ce…
CURRENT ISSUE
Volume XXXI, No. 5 – April 8, 2024
The fragmentation of consumer markets is reflected in clinical lab services, and The Dark Report examines this trend and how it will impact labs in the coming years. Also, The Dark Report notes that the FDA has issued a controversial memo to reclassify many high-risk IVD assays.
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