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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
New Breast Density Reporting Final Rule Set to Be Released
FDA confirms the new rule, which will update the Mammography Quality Standards Act, will publish before the end of 2022, or early 2023.
Changing Times and Eroding Margins: RCM Solutions
Learn how to comprehend the difficulties of revenue cycle management and practical technology-based solutions in this free webinar.
FDA to Consider Health Disparities in Granting Breakthrough Device Designation
Medical device makers will have to show that their products will be accessible to disadvantaged populations.
The State of State Licensing Law Restrictions on Telehealth
With temporary waivers of restriction relating to telehealth likely to end soon, here’s a roundup of the current state of state telehealth licensing law.
Four Things You Need to Know About the 2023 OPPS Payments Rule
The final Outpatient Prospective Payment System Final Rule for 2023 provides for a rate increase of nearly four percent.
Court Nixes COVID-19 Lab Test Reimbursement Lawsuit Against Private Payor
Despite Congress’ clear policy on private insurer payment of COVID-19 tests, many labs have been struggling to get reimbursed.
Five Things Labs Need to Know About the 2023 Clinical Lab and Physician Fee Schedule
In case you don’t feel like reading all 3,300+ pages of the Final Rule, here’s a quick briefing on the main changes you should be aware of.
Weekly Enforcement Report: COVID-19-Related Cases Take Center Stage
Though light on lab-related cases, last week’s enforcement actions cracked down on COVID-19-related violations.
CMS Hikes 2023 Medicare OPPS Reimbursement Rate 3.8 Percent
However, the increase still isn’t enough to keep pace with inflation, providers contend.
Healthcare Staffing Shortages Are Number 1 Issue in Recent Report
While likely not a surprise to medical labs, a new report may add more urgency to solving recruitment and retention issues.