Keep Informed on Legal and Compliance Developments Affecting Diagnostic Labs
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Analysis and insight on key compliance, legal, and business developments affecting laboratories
- Updates on changes to regulations
- Healthcare-related laws
- FDA approvals
- Business deals in the diagnostics space, and more
Latest Articles
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
Industry Trends: New Report Sheds Light on DX Tech Capital Flows
From - Laboratory Industry Report
The health care industry has raised $5 billion in venture fund investment in the first half of 2017 and is well on pace to smash the single year record of…
LDTs: TRICARE Beneficiaries Get At Least 3 More Years of Access
From - National Intelligence Report
Some of the labs that participate in TRICARE got some good news when the Department of Defense announced that it has extended the so called…
Chlamydia Testing Falls in Young Women, Following Change in Cervical Cancer Guidelines; Simultaneous Overtesting of Males Seen
From - Diagnostic Testing & Emerging Technologies
Recent cervical cancer screening guideline changes are associated with reduced chlamydia testing, particularly among women aged 15 to 19 years, who are…
2017 Looking Good for Health Care Investment;
Diagnostic Industry Poised for Large, Future Exits
From - Diagnostic Testing & Emerging Technologies
So far, 2017 is proving to be a good year for fundraising and investment in the broad health care industry, according to report by…
FDA Watch: Diagnostics Industry Is Losing a Longstanding “Frenemy”
From - Laboratory Industry Report
The diagnostics community is saying goodbye to a frenemy of 25 years. On Aug. 29, Alberto Gutierrez, director of the…
That CAN’T Be Right: Court Says Labs Must Independently Verify Medical Necessity of M.D. Ordered Tests
From - G2 Compliance Advisor
Based on the enforcement track record, if your lab ever gets charged with falsely billing Medicare for lab tests, failure to document the…
Draft 2018 CLFS Reveals Fundamental Flaws in PAMA Reporting Exercise; Time to Take Action
By Lâle White bio
As XIFIN predicted, the PAMA reporting exercise has resulted in significant proposed laboratory fee cuts. In fact…